FEHBlog

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NCQA, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House voted Sept. 1 on a continuing resolution (H.R. 6500) to fund the federal government through Dec. 11. The measure passed on a 370-48 bipartisan vote; the Senate passed its version by a vote of 90-6 on Aug. 8. The CR delays the Office of Management and Budget from finalizing its federal financial assistance proposed rule and prohibits any similar measure from being issued or finalized prior to Dec. 11. The AHA July 13 commented with concerns about the proposed rule, which would revise the Uniform Grants Regulation governing federal financial assistance.”
  • and
    • “The AHA Aug. 31 submitted comments urging the National Association of Insurance Commissioners Health Care Affordability and Mitigation Working Group to take a more comprehensive approach to evaluating healthcare affordability policies in a series of issue briefs being developed as a resource for state regulators and policymakers. The AHA called on the working group to assess consumers’ total financial burden, including premiums, deductibles, cost sharing and access to care, rather than focusing solely on any one measure, such as premium reductions or payer savings. The AHA also encouraged the working group to provide balanced analyses of policy options, including potential tradeoffs and unintended consequences, and to consider how health plan practices, such as prior authorization requirements, claims denials and network design, affect both affordability and patient access to care.”
  • Beckers Hospital Review adds,
    • “Mark Cuban argues the fundamental problem in U.S. healthcare is not whether the system is run by the public sector or the private sector. It is that hospitals do not know what their own services cost.
    • “During an Aug. 18 episode of KFF Health News’ “What the Health?” podcast, the entrepreneur and co-founder of Cost Plus Drug Co. said the lack of granular cost information undermines hospital pricing, reimbursement negotiations and broader debates over healthcare reform.
    • “The fundamental issue is transparency and trust … [and] there are a lot of hospitals that don’t know their costs,” he said. “They just know their cash balance.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today hosted the Live Real Life Symposium at the Hubert H. Humphrey Building in Washington, D.C., bringing together leaders from technology, medicine, research, education, government, and advocacy groups to examine the harms of screen use in children and discuss actionable approaches to supporting healthier childhood development.
    • “Our children get one childhood, and we cannot allow screens to replace the real-world experiences they need to grow and thrive,” said HHS Secretary Robert F. Kennedy, Jr. “Through the Office of the Surgeon General’s Live Real Life initiative, we are giving families practical tools to put technology in its proper place and get children back to playing, exploring, connecting, and experiencing the world around them.”
    • “The symposium is part of the HHS Live Real Life campaign, a national effort to help families, schools, and communities reduce harmful screen use and create more opportunities for children to engage in the experiences essential to healthy development.
    • “The event builds on the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents issued earlier this year, which outlines how factors such as age, content, design, purpose, and duration influence when screen engagement may be beneficial and when it becomes harmful.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $58 million investment is being delivered to improve health outcomes for Hawaiians through the federal Rural Health Transformation Program (RHTP). This investment will strengthen Hawaii’s healthcare workforce, improve infrastructure, advance technology, and support innovative approaches tailored to the unique healthcare needs across the state. 
    • “President Trump understands that every American deserves high-quality healthcare, no matter where they live,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are putting resources directly into rural communities to strengthen the health workforce, modernize infrastructure, expand access, and bring care closer to home. We are giving states the flexibility to build solutions around the people they serve, while demanding accountability for results. That is how we strengthen rural health, improve the lives of patients and families, and Make America Healthy Again.”
    • “President Trump made a historic commitment to rural America, and these investments are turning that commitment into better care for patients in communities across Hawaii,” said Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz. “This is what rural health transformation should look like: federal investment that is putting patients first, driving lasting improvements and expanding healthcare for the hardworking Americans who call these communities home.”
  • Reuters relates,
    • “U.S. Centers for Medicare and ​Medicaid Services Administrator ‌Dr. Mehmet Oz said on ​Monday [August 31] that 600,000 ​seniors have signed ⁠up to receive ​GLP-1 weight loss ​medications in the first two months of ​a new ​federal program created to expand ‌access ⁠to the highly sought-after treatments.
    • “Under the so-called Medicare ​Bridge ​program, ⁠which launched in July, ​millions of ​older ⁠Americans qualify for obesity medications at ⁠just $50 ​a ​month.”
  • GAO’s WatchBlog suggests “Nine Ways Congress Can Combat Fraud in the Federal Government,”
  • Fierce Healthcare tells us,
    • “Komodo Health, an AI-powered healthcare intelligence company, is teaming up with the National Committee for Quality Assurance (NCQA) to modernize how healthcare quality measures are developed.
    • “The multi-year strategic partnership will allow NCQA researchers to tap into Komodo’s Healthcare Map, made up of over 330 million de-identified patient journeys, to analyze care across insurance types, care settings and patient populations from a single longitudinal data source. 
    • “They will have access to Komodo’s Marmot, an AI-powered healthcare intelligence platform, to explore complex questions with transparent, reproducible outputs. NCQA is solely responsible for developing HEDIS measures.” * * *
    • “The goal is to allow NCQA to evaluate new measures more quickly and efficiently and to ensure HEDIS reflects real-world evidence. Developing new quality measures has historically required pulling from disparate datasets, including field testing with individual payers and other partners. This could take two to three months, and often had to be done separately for each population studied.
    • “Using Komodo’s Healthcare Map has greatly streamlined that process,” Tricia Elliott, VP of quality implementation at NCQA, told Fierce Healthcare in emailed comments. “Because the Healthcare Map includes insights from Medicare, Medicaid and commercial populations, our researchers can evaluate measures across multiple insurance types using a single, consistent data source rather than running separate analyses.”

From the U.S. Office of Personnel Management front,

  • Govexec reports,
    • “Each portfolio within the federal government’s 401(k)-style retirement savings program gained value last month, snapping a two-month streak of lackluster market performance.
    • “The international stocks of the Thrift Savings Plan’s I Fund sported the best performance, gaining 3.32% last month. So far this year, the I Fund has grown 19.18%.
    • “The C Fund, which is made up of large- and mid-size businesses, increased 2.72% in August, good for 13.12% growth since the start of 2026. And the small- and mid-size companies in the S Fund finished August 2.27% in the black, bringing its 2026 gains to 16.10%.”
  • OPM’s Director Scott Kupor added a new post to this Secrets of OPM blog today.
    • “Last week we at OPM recognized excellence among our team members through the Director’s Awards Ceremony.
    • “It not only gave me a chance to put my tuxedo to good use (which I almost never have a chance to do) and to tell the one joke I could remember that’s appropriate for a work setting, but – all kidding aside – it gave us an opportunity to recognize those who have gone above and beyond in service of the American people. And in doing so gave us the opportunity to walk the walk about what a high-performance culture means – one in which we are not afraid to call out individuals and teams that truly exceed expectations and in which we disproportionately reward excellence.
    • “I’ve written about this before (link to WAPO editorial), but the federal government has under-served its employees by trapping them in a system that treats accountability too lightly and fails to reward its top performers. We see this in the historical annual employee ratings systems – where less than 0.5% of a 2 million strong employee base rates below expectations and where nearly every SES (our most senior executives) is rated above expectations. And, as a result, we see this in the annual bonus system which provides little differentiation between satisfactory performance and those who consistently knock the cover off the ball.
    • “We’ve been working to change this culture into one that holds low performers accountable and forces managers to distinguish among their employees based on actual performance – both in ratings and in rewards (link to performance blog). While the Director’s Awards are not a substitute for the traditional end-of-year evaluation cycle, it is a great venue for us to practice what we preach.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Baxter International has recalled one lot each of 70% Dextrose Injection and Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter.
    • “The 70% Dextrose Injection may contain stainless steel particles, according to an Aug. 25 FDA alert. The affected product is lot Y495066, which expires July 31, 2027. It was distributed July 25-28, 2026, to healthcare providers and distributors in select states, including Alabama, Georgia and Tennessee.
    • “Baxter also recalled lot Y493475 of Anticoagulant Sodium Citrate Solution due to the potential presence of fiberglass. The product, which expires Dec. 31, 2027, was distributed July 2-11, 2026, to one customer in the U.S.” * * *
    • “As of Aug. 25, Baxter had not received any reports of adverse events related to either issue. Customers were instructed to immediately discontinue use of affected units and return them.”
  • Oncology News Central relates,
    • “On Aug. 31, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft (Besremi) for adults with essential thrombocythemia (ET), marking the first approval for the rare blood cancer in nearly three decades.
    • “Regulators based their decision on results from the open-label, multicenter, randomized SURPASS ET clinical trial. The phase 3 study enrolled 174 adults with ET who had an inadequate response to hydroxyurea. 
    • “Today’s FDA approval of [ropeginterferon alfa-2b] for ET is a significant advancement for patients and reflects PharmaEssentia’s longstanding commitment to advancing innovative therapies for people living with myeloproliferative neoplasms,” PharmaEssentia CEO Ko-Chung Lin, PhD, said in a statement. “We have been working closely with the FDA, healthcare providers, advocacy organizations, and payers to bring this important treatment option to the ET community.”
  • STAT News lets us know,
    • “Medical device giant Stryker earlier this summer received Food and Drug Administration authorization for a surgical display system using Apple’s Vision Pro headset. Specifically indicated for imaging during minimally invasive surgery for hip impingement and labral repair, SportSuite Vision allows a surgeon to place multiple displays that are usually scattered around an operating room in their preferred configuration in the Vision Pro’s display. During a procedure, surgeons usually need to swivel their heads and bodies to refer to CT imaging, arthroscopic video, and Stryker software.
    • “The De Novo authorization was based on hundreds of hours of lab testing, including work on cadavers and testing interactions with other staff, but the company is announcing today that a surgeon at Duke Health completed a real procedure using the technology.
    • “Matt Moreau, VP and general manager of sports medicine at Stryker, told me the company has long wanted to create such a “surgical cockpit,” but Vision Pro is the first to deliver on the technical capabilities necessary, including  high-quality passthrough video that allows a surgeon to see the operating room and staff around them.”

From the judicial front,

  • “A panel of three Republican judges (two Trump first term appointees and one George H.W. Bush) from the U.S. Court of Appeals for the 11th Circuit unanimously overruled a district court decision holding the False Claims Act’s qui tam provision unconstitutional.  Here is an 11th Circuit link to the opinion.”
  • In short this is the Court’s holding:
    • “Here, a relator brought an FCA suit against defendants that she alleged committed Medicare fraud, and the defendants moved for judgment on the pleadings or dismissal on the grounds that the qui tam provisions violated the Constitution’s Appointments Clause, Take Care Clause, and Vesting Clause. The district court granted the defendants’ motion and held that the qui tam provisions violate Article II’s Appointments Clause because relators qualify as officers of the United States and, as such, must be (but are not) presidentially appointed.
    • “We disagree and hold that relators are not officers of the United States because they do not occupy a continuing position established by law. Accordingly, we join our sister circuits that have addressed this issue and hold that the qui tam provisions of the FCA do not violate the Appointments Clause. Therefore, we vacate the district court’s order dismissing this case and remand for the district court to evaluate the defendants’ remaining constitutional arguments.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “COVID-19 cases are ticking up in almost every U.S. state as summer draws to a close, according to the latest data from the Centers for Disease Control and Prevention.
    • “COVID-19 activity was still categorized overall as “very low” nationwide by the agency as of Aug. 28, though cases are consistently increasing. This is likely the result of what has come to be known as the “summer surge,” a pattern that doctors have observed each year since around 2022. Unlike other respiratory illnesses such as the flu, COVID-19 tends to flare not only during the typical winter cold and flu season, but also toward the end of summer.
    • “Experts previously told USA TODAY that this is likely caused by multiple factors, including behavioral and environmental changes (the amount of time spent cooped up in AC, going back to school, etc.), as well as the virus’s life cycle and how our immunity to it waxes and wanes.
    • “COVID-19 is rising nationally but from a low baseline,” Dr. Syra Madad, infectious disease epidemiologist at Harvard’s Belfer Center and chief biopreparedness officer for New York City’s public hospitals, previously told USA TODAY. “The increase became apparent in parts of the South and West during July and more clearly nationwide by late July and early August.”
  • Beckers Behavioral Health relates,
    • “The CDC predicts 67,798 drug overdose deaths in the U.S. during the 12 months ending in March 2026, a 12.3% decrease compared to the same time period in the previous year, according to an Aug. 31 news release from the agency.”
  • NPR tells us,
    • “Maria Uloko sees the same scenario in her urology practice in Los Angeles every day: A woman has been diagnosed with recurrent urinary tract infections (which means she’s had at least two in six months or three in a year), taken repeated rounds of antibiotics, and feels confused as to why the infections keep coming back.
    • “Then, Uloko tells these patients something that often feels both revelatory and frustrating. “Most of them don’t actually have UTIs, even though that’s been their diagnosis time and time again,” she says. “In fact, millions of women are being treated for UTIs they may not actually have.”
    • “Uloko is the co-author of a recent study published in The Journal of Sexual Medicine that backs this up. She and her fellow researchers reviewed the medical records of 253 women with recurrent UTIs and found that just 15% showed evidence of problems that were limited to the bladder or urinary tract. The remaining 85% had signs of hormonally driven inflammation of the vulvar region and 75% had pelvic floor dysfunction.
    • “These conditions produce identical symptoms as UTIs — burning with urination, urgency, frequency, and/or lower abdominal pain — but require different treatment.
    • “What we found is that in women with recurrent UTIs, the majority didn’t have a bladder problem at all; they had a vulvar problem,” says Uloko.”
  • STAT News informs us,
    • “New guidelines released Monday highlight the many new treatments that have hit the market in recent years for the prevention of migraine. 
    • “The guidance for health care providers comes from the American Headache Society and the American Academy of Neurology, which last updated their recommendations in 2012. 
    • “There has been a wealth of new treatment available,” said Rebecca Burch, guideline co-author and neurologist at the University of Vermont Medical Center. Burch also co-authored the previous guidance. 
    • “Among the key updates are at least a half dozen medications that were approved for migraine prevention by the Food and Drug Administration since 2012. Many of those focus on blocking the calcitonin gene-related peptide, or CGRP, pathway, which is implicated in migraine. 
    • “The new guidelines advise doctors to offer preventive treatment to people who have at least four migraine or severe headache days per month, or whose migraines interfere with their ability to work or complete daily tasks. An estimated 15% of Americans experience migraines, with women disproportionately affected. Many try to manage their pain with over-the-counter options once an attack has begun.” 
  • Health Day points out,
    • “Adults who spend hours scrolling social media every day are more likely to develop depression, a new study says.
    • “Around 2.5 hours or more of scrolling per day is linked to self-reported depression, researchers recently reported in the journal npj Mental Health Research.
    • “The study found that social media is more closely linked to depression than other factors like your job, your educational background, or your time spent playing video games, surfing the web or watching TV, researchers said.
    • “It’s a damning picture. Social media is harmful for individuals across the lifespan,” senior researcher Hans Breiter, a professor at the University of Cincinnati, said in a news release.
    • “We should not subject ourselves to a product using addiction science to optimize our viewing time,” Breiter said.”
  • Per Reuters,
    • “People taking popular GLP-1 obesity drugs who remain on low starter doses will ​lose some weight but may still experience side effects, although significantly less nausea than those who graduate ‌to higher manufacturer-recommended doses, a new study suggests.
    • “And they are unlikely to experience the double-digit weight-loss percentages seen with the higher doses, the study found.
    • “The GLP-1 drugs semaglutide, sold as Ozempic and Wegovy by Novo Nordisk (NOVOb.CO), and Eli Lilly’s (LLY.N) tirzepatide, sold under the brand names Mounjaro and Zepbound, are prescribed ​initially at a low dose followed by gradual titration to higher doses, to help the body adjust and minimize side ​effects.”
  • Cardiovascular Business notes,
    • “Catheter ablation does not significantly improve the quality of life of patients with symptomatic atrial fibrillation (AFib) more than a sham procedure involving sedation, venous access and electrical cardioversion, according to new late-breaking data presented at ESC Congress 2026. The findings were simultaneously published in The Lancet.[1]
    • “PVI-SHAM-AF was a randomized, double-blind, sham-controlled trial included more than 250 patients with symptomatic paroxysmal or persistent AFib. Patients were randomized to undergo either catheter ablation or a sham procedure. The sham procedure was rather complex, involving sedation, venous access, time in the electrophysiology lab and even cardioversion. Each participant completed an AF Effect on the Quality of Life Questionnaire (AFEQT) at baseline and again after six months. 
    • “Overall, 173 patients were treated with catheter-based pulmonary vein isolation (PVI) ablation and another 89 patients were treated with the sham procedure. After six months, AFEQT scores improved from 61.3 to 81.1 in the catheter ablation group and from 59.2 to 74.9 in the sham procedure group. This was not viewed as a significant difference. 
    • “On the other hand, the authors noted that catheter ablation was still proven to be effective in reducing the risk of recurring episodes of AFib. Freedom from AFib after six months occurred in 73% of catheter ablation patients and 52% of sham procedure patients.”
  • and 
    • “Metformin, a popular type 2 diabetes medication used to reduce blood glucose levels, does not appear to make a significant impact on outcomes for patients with heart failure with reduced ejection fraction (HFrEF). That is according to two separate studies presented at European Society of Cardiology (ESC) Congress 2026.
    • “The first of the two studies, Met-HeFT, included 940 heart failure patients in Denmark who either presented with type 2 diabetes or face an increased risk of developing type 2 diabetes. The mean age was 70 years old, and 84% of patients were men. Study participants were randomized to either undergo treatment with metformin or a placebo.
    • “Overall, after a mean follow-up period of 3.7 years, there was no significant difference in the study’s primary endpoint—a composite of mortality, worsening heart failure symptoms, acute myocardial infarction or stroke—between the two groups. That outcome occurred in 25.1% of metformin patients and 23.4% of placebo patients. Secondary endpoints, including new-onset diabetes and unplanned heart failure rates, were also not significant different between the two treatment options.
    • “It is worth noting, however, that just approximately one in 10 patients presented with type 2 diabetes. The remaining patients were all determined to face a heightened risk of developing type 2 diabetes.”
  • BioPharma Dive adds,
    • “A pill developed by Novartis succeeded in a pair of Phase 3 trials in people with a common form of multiple sclerosis, bolstering confidence in the drug’s prospects and sending company shares up by over 4% on Tuesday.
    • “The Swiss pharmaceutical giant didn’t provide detailed study results. Still, Novartis revealed the therapy, remibrutinib, demonstrated “superiority” over the drug Aubagio in reducing yearly relapse rates and inflammatory brain lesions in study participants. Treatment was associated with “clinically meaningful” effects on disability progress and, notably, didn’t impact liver safety — an issue for multiple drugs in remibrutinib’s class. 
    • “The findings could position remibrutinib, which is already approved as Rhapsido for chronic skin hives, to become a bigger sales contributor in the future. Novartis is looking to remibrutinib and other late-stage prospects to offset revenue losses from multiple patent expirations. It intends to share the MS study results with health regulators.” 
  • and
    • “An experimental drug Alumis has been testing in a form of lupus failed a mid-stage study, but the company will press forward after observing positive signs in a subgroup of trial participants.
    • “According to Alumis, the drug, envudeucitinib, missed all of its main and secondary objectives in systemic lupus erythematosus. Still, “robust” responses were seen in trial volunteers with “high interferon gene signature,” meaning certain genes controlled by interferons are overexpressed. A majority of people with moderate-to-severe SLE fit this description, Alumis said.
    • “Alumis will meet with regulators to discuss a path toward a Phase 3 trial. Company shares plummeted by nearly 55% on the results, though, nearly erasing all of Alumis’ stock gains this year. The company’s market value had soared following positive results in psoriasis in January.” 

From the U.S. healthcare business front,

  • Beckers Payers Issues calls attention to the following:
    • “Several of the nation’s largest health insurers rolled out reimbursement policy changes Sept. 1, ranging from new lab testing coverage limits at UnitedHealthcare to a billing overhaul at Blue Cross Blue Shield of Michigan that has drawn pushback from providers.”
  • and 
    • “UnitedHealthcare has released the specific procedure codes it will exempt from prior authorization as part of the insurer’s previous pledge to reduce requirements by 30% before the end of 2026.
    • “The code lists cover 1,700 procedure codes for a range of services across commercial, Medicare Advantage, individual exchange, and Medicaid plans. Effective Oct. 1, providers will no longer need to seek the insurer’s approval for many outpatient procedures, including lesion excisions, fracture treatments, joint injections, arthroscopies, colonoscopies, endoscopies, biopsies, hernia repairs and soft tissue tumor removals. Genetic and molecular testing codes also make up a large  portion of the lists.
    • “UnitedHealthcare CEO Tim Noel said in May that prior authorization “should only be used when it truly protects patients and improves care.” At the time, the insurer said it requires prior approval for just 2% of its medical services, with roughly 92% of submitted requests approved in less than 24 hours on average. The 30% reduction builds on an earlier 20% cut to commercial prior authorization requirements in 2023.”
  • HR Dive reports,
    • “Despite the current economic turbulence, most employees in a majority of companies will be getting a base salary increase for 2027, according to a large survey by Korn Ferry.
    • “Almost half (47%) of the 5,512 participating employers said they expect to provide salary hikes to at least 95% of their employees, while 79% expect to do so for at least 80% of employees. Only 2% said they are planning no increases for anyone.
    • “U.S. organizations expect to boost overall base-salary budgets next year by an average of 3.3% and a median of 3%. The median increase for U.S. executive and senior management is also anticipated to come in at 3.0%. 
    • “The survey was conducted in June of this year.”
  • Fierce Pharma unveiled its Fierce 50 awardees of 2026.
  • Beckers Hospital Review tells us,
    • “Philadelphia-based University of Pennsylvania Health System recorded operating income of $336.9 million (2.5% operating margin) for fiscal year 2026, up from operating income of $246.7 million (2.1% margin) during the same period last year, according to its Aug. 28 financial report.”
  • and
    • “Boston-based Dana-Farber Cancer Institute posted an operating loss of $9.1 million (-0.9% margin) in the third quarter of fiscal 2026, compared with an operating loss of $2.6 million (-0.3% margin) in the same quarter last year, according to its Sept. 1 financial report.”
  • and
    • “From R1 RCM striking an agreement to acquire an AI-powered touchless prior authorization company to IKS Health acquiring TruBridge, [the article identifies] 12 revenue cycle company mergers and acquisitions that have been announced or completed since March 17.”
  • Beckers Clinical Leadership informs us,
    • “Single specialty and multi-specialty groups were the top two highest-paying settings for physicians, followed by hospitals, Doximity found. 
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of nearly  23,000 responses collected in 2025, according to a company news release.  
    • “Among settings, solo practice had the largest drop in compensation year-over-year at -3.8%, while urgent care centers had the highest growth for the second year in a row, the report said.” 
  • and
    • “Most physicians say they’d still choose medicine if they had it to do over again, but nearly half say they’re likely to leave clinical practice within the next two years, according to Doximity’s 2026 Physician Compensation Report.
    • “Doximity, a digital platform for U.S. medical professionals, released the report Aug. 25. The findings are based on a survey of physicians conducted in June on how AI is changing physician careers and pay, along with salary data from more than 23,000 physicians collected in 2025, according to a company news release.”
  • MedTech Dive notes,
    • “Medtronic kicked off its fiscal year with double-digit revenue growth, building on momentum the company posted coming out of its previous year.
    • “Medtronic grew revenue by 13.7% to $9.8 billion in its fiscal first quarter, fueled by double-digit growth in its cardiovascular and medical surgical businesses. The strong quarter prompted the company to increase its organic revenue growth forecast for the full fiscal year.
    • “Importantly, these results reinforce our confidence and the durability of our business,” CEO Geoff Martha told investors on a Tuesday earnings call.
    • J.P. Morgan analyst Robbie Marcus wrote in a note to investors that Medtronic beat Wall Street’s consensus expectations in sales by about $220 million in the quarter.
    • “Much like in the fourth quarter, Medtronic’s cardiovascular unit was a bright spot for the company. The business brought in $3.93 billion in revenue, representing nearly 20% growth year over year.”

Monday report

David Ermer–Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Federal News Network reports,
    • “House lawmakers return to Washington on Monday with a short to-do list after five weeks back in their home districts. The first order of business is likely a vote on a stopgap spending bill designed to keep the federal government fully funded through early December, removing the possibility of a shutdown before the midterm elections.” * * *
    • “House Speaker Mike Johnson is expected to tee up the funding bill early in the week. The bill underwent some significant changes in the Senate, which made it more palatable for Democrats. It delays a proposed rule from the Office of Management and Budget that would give political appointees more power over the distribution of federal grants. It also includes language to ensure the administration can’t transfer funds to the Border Patrol.
    • “But a provision that delays for one month a federal ban on intoxicating hemp THC products has prompted criticism from many GOP lawmakers. As a result, GOP leaders will likely place the bill on a fast-track process that avoids a separate procedural vote. Suspension bills require a two-thirds vote to pass, meaning a significant number from both parties need to support the measure for it to pass and advance to Trump’s desk.
    • “Lawmakers are anxious to avoid the possibility of a shutdown as voters weigh their options going into November. The funding bill passed by a 90-6 vote in the Senate, showing that lawmakers from both political parties want to avoid a repeat of the two historic shutdowns that occurred this past year.”
  • The Wall Street Journal relates,
    • The Trump administration reached agreements for most-favored-nation drug pricing with nine pharmaceutical companies, including Teva Pharmaceuticals, Astellas Pharma, and BridgeBio.
    • The agreements provide for all state Medicaid programs to pay prices for prescription drugs that match the lowest prices paid by other developed nations, the White House said Monday, adding that the agreements also guarantee MFN pricing for all new medicines the companies bring to market.
    • The U.S. has now reached 26 such deals covering 89% of the branded drug market, the White House said.
    • The nine companies—which include Alcon, BeOne Medicines, CSL, Kyowa Kirin, Sun Pharma, and UCB—also agreed to collectively commit $19.6 billion to manufacturing in the U.S. in the near term, the White House said. Some of the companies also agreed to donate active pharmaceutical ingredients to a federal stockpile.
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today announced on Overdose Awareness Day that it has awarded $77 million in new grant funding to strengthen substance use prevention, treatment and recovery, community mental health, suicide prevention, and crisis services. The announcement comes as National Substance Use Primary Prevention Month draws to a close, with more than $22 million of the funding supporting critical substance use prevention efforts in communities.
    • “Every American deserves the chance to live free from addiction and the devastation of untreated mental illness,” said HHS Secretary Robert F. Kennedy, Jr. “President Trump’s Great American Recovery is taking on these crises at their roots. We are investing in prevention, expanding access to effective treatment, strengthening crisis response, and helping communities intervene before tragedy strikes. Our goal is clear: save lives, restore families, and help more Americans achieve lasting recovery and better health.”
  • The Census Bureau tells us,
    • “The share of the world population age 65 and older is projected to nearly double from 10.5% to 19.6% between 2025 and 2060, according to a new report released today by the U.S. Census Bureau.
    • “An Aging World: 2025 finds that the global population is aging faster than ever before. Between 2020 and 2025, the proportion of the population age 65 and older exceeded the population age 5 and younger for the first time in recorded history.
    • “In 2025, the United States ranked the 48th oldest country out of 227, with 18.9% of its population age 65 or older. By 2060, older adults are projected to make up 23.4% of the U.S. population. Yet the United States will fall to 110th place globally because other countries are aging much more rapidly.”

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “Boston Scientific plans to stop selling certain angiographic catheters after a manufacturing problem led the company to pull the devices from the market. 
    • “The medical device manufacturer sent a letter to customers last week instructing them to immediately stop using or distributing all Imager II Angiographic Catheters due to an issue that can increase the risk of the tip detaching. The Food and Drug Administration posted an early alert on Friday.
    • “Boston Scientific had reported two serious injuries associated with the problem as of July 16.”
  • Fierce Pharma informs us
    • “These are heady days for PharmaEssentia, a biotech that got its start 23 years ago in Taiwan, went public 10 years later and is now deepening the foothold of its first commercial product, Besremi.
    • “There’s a lot of electricity in the air in the organization right now,” Samuel Lin, PharmaEssentia’s Head of U.S. Global Operations, said in an interview with Fierce. “Sometimes you have to stop and pinch yourself a little bit.”
    • “The excitement ramped up on Monday as the FDA signed off on a key label expansion for Besremi, endorsing it as a treatment for the rare bone marrow disorder essential thrombocythemia (ET). 
    • “The label specifically covers adults with ET regardless of their genotype or disease status, including newly diagnosed patients who haven’t received cytoreductive therapy, according to an Aug. 31 release.”

From the public health and medical / Rx research front,

  • Healio reports,
    • “The United States’ death rate likely dropped to a record low last year, according to provisional CDC data.
    • “The National Center for Health Statistics (NCHS) released the report, which offers an early estimation of the deaths that occurred in 2025, in late July.” * * *
    • “The new data show that, in 2025, there were 3,094,593 deaths, and the overall mortality rate was 689.2 per 100,000 people — 4.6% lower than the 2024 rate of 722.1 per 100,000 people. The leading causes of death remained the same, though, with heart disease, cancer and unintentional injuries in the top three spots.
    • “In the 2025 provisional data, the age-adjusted mortality rate was 582.9 for women and 811.1 for men. It dropped for every age group. Additionally, the age-adjusted mortality rates were the highest in the Black non-Hispanic population at 869 per 100,000 and lowest for “the multiracial non-Hispanic population” at 187.3 per 100,000.” * * *
    • “Although nothing is confirmed, some experts have pointed to the decline in overdose deaths as a reason for the lowered mortality rate.”
  • The New York Times points out,
    • “It’s been two months since Ericka Ratliff, 55, fell ill with cyclospora, yet she is still dealing with sharp abdominal pains and sudden urges to go to the bathroom. “It’s very unpredictable,” she said, as if “my stomach is just extremely angry.”
    • “Ms. Ratliff, who lives in Adrian, Mich., has tried following a bland diet and eating small, frequent meals to quell her symptoms, but she said she worried that her gut would “never be the same again.”
    • “Research suggests that roughly 10 to 20 percent of people who get intestinal illnesses from bacteria, viruses or parasites will end up having symptoms, like diarrhea and abdominal pain, that can last for months or even years. This condition is called post-infection irritable bowel syndrome.
    • “It’s too soon to know whether Ms. Ratliff is dealing with post-infection I.B.S. But after the recent surge in cyclospora infectionsin the United States, along with other foodborne illness outbreaks linked to jalapeños, sprouts, frozen blueberries and more, some gastroenterologists worry that they may soon be seeing more patients with the condition.
    • “I’m expecting our clinics to be getting inundated,” said Dr. Baha Moshiree, a gastroenterologist and professor of medicine at Wake Forest University School of Medicine in North Carolina.”
  • and
    • “After the unpredictability of last year’s flu season, when a new variant of the virus spread widely and rapidly, infectious disease experts are hoping for a tamer fall and winter this year.
    • “Scientists look to countries like Australia, in the Southern Hemisphere, for clues about how the flu will play out. This year, the flu seems to be circulating in those regions at relatively moderate levels, and this year’s flu shots appear well matched to combat the virus. But it’s uncertain whether that will change as flu season unfolds in the Northern Hemisphere.
    • “I’m cautiously optimistic,” said Dr. Scott Roberts, an assistant professor of infectious diseases at the Yale School of Medicine, emphasizing “cautiously.”
    • “Doctors are also reassured that there are new options for vaccination against the flu, and that at-home tests have entered the market in recent years.”
  • Health Day relates,
    • “For people with asthma or COPD, reaching for a rescue inhaler too often may be a warning sign — not just for their lungs, but for their heart.
    • “It’s estimated nearly 1 in 5 asthma patients and 1 in 3 COPD patients overuse these products.
    • “Researchers analyzed real-world health data from more than 280,000 asthma and COPD patients in Belgium.
    • “They found frequent use of short-acting reliever inhalers, also called bronchodilators, was associated with a higher risk of cardiovascular disease and death, including heart failure, heart attack and ischemic stroke.”
  • and
    • “Integrated cognitive behavioral therapy (CBT) is effective for primary care patients with depression, according to a study published in the June issue of The Lancet Primary Care.
    • “Debbie Tallon, from University of Bristol in the United Kingdom, and colleagues evaluated the clinical effectiveness of integrated therapist-delivered CBT (consisting of combined one-to-one CBT delivered by instant messaging with an accredited CBT therapist and online resources) in reducing depressive symptoms for primary care patients. The analysis included 334 adults meeting depression criteria, randomly assigned to nine integrated CBT sessions through the INTERACT therapy platform or usual care.
    • “The researchers found that at six months, the mean Beck Depression Inventory score was significantly lower in the intervention group versus control (22.5 versus 27.4; adjusted difference in means, –4.4; effect size, 0.43). There were more adverse events in the intervention group (33 versus 21 in the control group), including serious adverse events (12 versus two in the control group). Self-harm (six patients) and referrals to a mental health team (six patients) were the most common. Of the serious adverse events, none were definitely or probably related to the intervention.”
  • The American Medical Association lets us know “what doctors want patients to know about sodium consumption.” 
    • Sodium isn’t just lurking in heavily salted snacks. Two physicians discuss where sodium resides and which choices to make to avoid it in excess.
  • tctMD tells us,
    • “People over age 70 with no history of cardiovascular disease see dramatic reductions in major adverse cardiovascular events when newly prescribed statin therapy for primary prevention, according to results of the STAREE trial.
    • “Compared with those given placebo, patients taking 40 mg of atorvastatin once daily had a 30% lower incidence of CV death, nonfatal MI, stroke, or coronary revascularization (6.0% vs 8.3%; P < 0.001) over the 6-year study period. There was, however, no difference between groups in the incidence of disability-free survival, defined as a composite of death from any cause, dementia, or persistent physical disability.
    • “In a media briefing here prior to the presentation at the European Society of Cardiology Congress 2026, lead author Sophia Zoungas, MBBS, PhD (The George Institute for Global Health, Sydney, Australia),  said the data answer important questions about the safety and efficacy of statins in older people.”
  • MedPage Today informs us,
    • “Nearly half of adults who started semaglutide (Wegovy) for obesity management stopped treatment within a year, a Danish cohort study showed.
    • “Among 157,822 first-time semaglutide initiators without diabetes, 49% discontinued treatment by 12 months, defined as a prescription gap of 60 or more days. Discontinuation steadily increased from 13% by 3 months, to 27% by 6 months, and 39% by 9 months.
    • “However, one in four discontinuers restarted therapy within 3 months, Aurélie Mailhac, MSc, of Aarhus University Hospital in Denmark, and co-authors reported in JAMA Network Open.
    • “These findings may reflect frequent temporary treatment interruptions or self-adjusted dosing below guideline-recommended levels,” they wrote.”
  • Per BioPharma Dive,
    • “Novartis and Bristol Myers Squibb have paused multiple trials evaluating their respective cell therapy programs against autoimmune conditions after observing inflammatory side effects in testing, the companies confirmed Monday afternoon.
    • “Novartis, which is testing a personalized cell therapy called rap-cel in a handful of autoimmune studies, found three cases of immune effector cell-associated hemophagocytic syndrome, a rare and possibly life-threatening reaction. The company said it initiated holds on those trials — which are evaluating rap-cel in lupus, myasthenia gravis, multiple sclerosis and more — on Aug. 24. Novartis is “engaged” with regulators and is reviewing the findings, according to a company spokesperson. 
    • “The temporary halt will allow for a more comprehensive review of the evolving clinical and safety data across the program,” the spokesperson wrote in an email to BioPharma Dive.”

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

  • Beckers Payer Issues reports,
    • “High deductible health plans may reduce how much people spend on healthcare in the short term, but they don’t appear to slow the rate at which that spending grows over time, according to a study of more than 324,000 commercially insured members published in the International Journal of Health Economics and Management.
    • “The study, published in May, was led by researchers at the University of Pennsylvania’s Wharton School and included co-authors from Analysis Group, the Elevance Health Public Policy Institute and Georgia State University.”
  • Beckers ASC Review adds,
    • “From a jointly built AI documentation tool with Abridge to three distinct growth partnership models, Oakland, Calif.-based Kaiser Permanente has spent the past few months navigating expansion, labor tension and legal exposure.”
  • Fierce Healthcare relates,
    • “It’s been nine months since the opening of the country’s largest all-electric acute care hospital in Irvine, California.
    • “UCI Health was already in the planning stages of its new Irvine campus when the University of California (UC) established a policy that no new or renovated buildings could burn fossil fuels for space and water heating. 
    • “The health system may have gotten an exemption as a healthcare facility. But leadership decided to push the boundaries of hospital design by going all-electric. The ambitious plan was not purely a cost-saving strategy. According to Tony Dover, UCI Health’s energy management & sustainability officer, it was a moral imperative.
    • “We were doing it because it was the right thing to do,” Dover told Fierce Healthcare. “It was for decarbonization, resilience, and we’re mitigating our pollution for the community that we serve.”
  • Healthcare Dive notes,
    • Name: Michael Grasher
    • Previous title: Chief financial officer, IFG Companies
    • New title: Chief financial officer, Teladoc Health
    • Teladoc has appointed Grasher as its CFO effective immediately, the telehealth firm announced Monday. He’s succeeding Mala Murthy, who departed in November after six years for another opportunity.
    • Grasher has more than three decades of experience across insurance and financial services, including more than 12 years as a chief financial officer.
  • Beckers Hospital Review tells us,
    • “Contract breaks between major health systems and certain Medicare Advantage insurers are continuing in 2026. Providers [listed in the article] dropping plans often cite prior authorization denials and slow reimbursement; in other cases, insurers are terminating the contracts themselves.
  • and
    • “Charlotte, N.C.-based Advocate Health recorded an operating income of $775.3 million (3.8% operating margin) during the first six months of 2026, down from $824.4 million (4.4% margin) during the same period last year, according to its Aug. 27 financial report.”
  • and
    • “Burlington, Mass.-based Tufts Medicine’s operating margin fell to -3.4% through the first nine months of fiscal 2026, compared with -2.3% during the same period a year earlier, as the health system’s CEO and CFO prepare to step down.
    • “Tufts reported an operating loss of $79.5 million on $2.4 billion in revenue for the nine months ended June 30, according to financial documents filed Aug. 28. That compares with an operating loss of $50 million on $2.2 billion in revenue during the same period in fiscal 2025.”
  • Beckers Clinical Leadership informs us,
    • “Internal medicine is the most in-demand physician specialty and locum tenens specialty, Doximity found.
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of more than 23,000 responses collected in 2025, according to a company news release. To find the most in-demand jobs, the company analyzed tens of thousands of job postings across its network in 2025.
    • “Doximity also found the specialties with the highest demand for locum tenens. This is an increasingly popular way for physicians to supplement their income and practice with more flexibility, according to the report. 
    • “Three of the four most in-demand specialties and locum tenens were primary care specialties. Eight specialties appeared on both lists [found in the article]. 
  • and
    • “Three out of four physicians say they would accept lower pay in exchange for greater autonomy or work-life balance, a preference that has remained remarkably consistent over the past four years, according to a Doximity poll of nearly 1,000 physicians conducted in July 2026.
    • “The share of physicians willing to trade compensation for autonomy or work-life balance has held steady at 71% in 2023, 75% in 2024, 77% in 2025 and 76% in 2026. The preference is significantly stronger among women physicians at 86% compared with 71% of men, which has slightly widened compared to the prior year.”
  • The Wall Street Journal lets us know,
    • “Eli Lilly remains on a shopping spree, agreeing to pay up to $2.875 billion in cash for biotechnology company Merida Biosciences in a deal that bolsters the drugmaker’s immunology portfolio.
    • “Eli Lilly on Monday said privately held Merida is advancing a new class of precision therapeutics for serious autoimmune and allergic diseases, with its lead program in Phase 1 development for Graves’ disease and thyroid eye disease.
    • “The Merida deal continues a spate of acquisitions by the Indianapolis company, which is flush with cash from its market-leading weight-loss-drug franchise.”
  • The New York Times adds,
    • “Revolution Medicines set a sticker price of about $480,000 a year, or $663 a tablet, for its new pancreatic cancer drug — a cost that would have once been unthinkably high.
    • “Today, such prices are routine for cancer drugs.
    • “One cutting-edge CAR-T therapy now goes for $600,000 for a one-time infusion. A competitor, given the same way, is listed at $550,000. A daily pill for gastrointestinal cancer has a sticker price of $520,000 a year. A twice-daily pill for leukemia? It’s $430,000 a year.
    • “In 2024 alone, nine cancer drugs were approved and then introduced with sticker prices above $400,000 annually, according to a tally by the Institute for Clinical and Economic Review, which evaluates the value of medicines.
    • “That these prices have become commonplace would have been hard to imagine two decades ago, when even the prospect of a $100,000-a-year cancer drug evoked fierce criticism.
    • “But since then, cancer drug prices have steadily increased, with few constraints beyond what a company thinks the market will bear. The expense is borne by government programs like Medicare, employers, patients and Americans who pay taxes and health insurance premiums.”

Weekend update

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

Simplicity is a virtue.

From Washington, DC

  • According to the House Majority Leader’s weekly calendar, the House will be taking up the Senate’s FY 2026 continuing resolution this week.
  • The Wall Street Journal reports,
    • “Social Security faces looming insolvency and automatic benefit cuts in 2032, prompting accelerated discussions in Congress.
    • “Lawmakers are floating bipartisan ideas, including a commission to propose solvency plans and eliminating the cap on Social Security payroll taxes.
    • “Delaying action has made the eventual adjustments more severe, as past tax or spending changes are no longer large enough to close the funding gap.”
  • Tech Target tells us,
    • “The goals of the 21st Century Cures Act are being realized, as more patients look at their EHRs and lab results, according to a group of researchers from NYU’s School of Global Public Health.
    • “But there is a catch, the researchers said. Not all of these people understand what they’re looking at, especially when they view lab and test results before they can consult with their doctor.” * * *
    • “We wanted to understand whether a patient’s probability of accessing test results — and understanding of them — varies based on sociodemographic characteristics, health status, patient-centered communication, and digital health literacy,” Jemar Bather, Ph.D., assistant professor of biostatistics at NYU School of Global Public Health and the study’s lead author, said in a press release.
    • “Bather and colleagues surveyed nearly 5,000 patients who had access to their digital medical records and received a test result within the previous year. They found the Cures Act was mostly delivering on its promise. More than two-thirds of the survey respondents (68.6%) said they’d immediately viewed a test result before talking to their provider.
    • “Still, comprehension was lacking, with a sizeable proportion of patients saying they didn’t entirely understand their lab results when they looked at them.
    • Of those who viewed their results immediately, 6.6% said they had a poor understanding, while another quarter (26.8%) said they understood them only fairly well. Just under a third (31.7%) understood their results well, and 34.9% understood them very well.” * * *
    • “Specifically, understanding of medical notes and labs was mostly concentrated among the most engaged patients, the data suggested. These folks tended to be older, female, high-income and have a greater number of chronic conditions, the researchers pointed out. They also had higher digital literacy and were more likely to use social media for their health.
    • “Meanwhile, some groups are slipping through the cracks. Individuals living in the Midwest or the South, as well as those experiencing discrimination in the medical setting, were less likely to understand their test results.”
  • Drug Topics relates,
    • “Johns Hopkins, ASTHO, and CSTE partnered with state/territorial agencies to deliver a standardized, validated [vaccine preventable diseases] VPD dashboard, with >25 jurisdictions committed and broader expansion planned for 2026. 
    • Age-stratified, jurisdiction-comparable reporting aims to improve epidemiologic interpretability and policy utility beyond traditional national surveillance, while maintaining non-identifiability and data security. 
    • Voluntary state health department feeds populate participating jurisdictions, and CDC NNDSS data backfill nonparticipants, enabling a more complete national picture with substate granularity. 
    • Localized incidence signals can trigger pharmacist-led standing-order immunization escalation and more aggressive encounter-, diagnosis-, procedure-, periodic-, and occupational-screening workflows. 
    • Persistent mortality and missed vaccination opportunities underscore the need for actionable surveillance; pharmacists are positioned to close gaps through education, administration, advocacy, and treatment optimization.

From the U.S. Office of Personnel Management front,

  • “Survivors, family members, and estate representatives are required to notify OPM when a federal retiree or benefit recipient passes away. This page has the contact numbers, hours, mailing address, and steps to report the death and initiate life insurance claims.” A financial incentive to report exists when the deceased has a survivor annuitant. The financial incentive is missing when a survivor annuitant passes away. In any case this website explains how to report such a death. The website does not suggest that the death be reported to the FEHB or PSHB plan.

From the public health and medical / Rx research front

  • NBC’s Today Show reports,
    • “New infections with cyclospora, the “explosive” diarrhea-causing parasite that’s sickened thousands of Americans this summer, appear to be on a downward trend, according to new data.
    • “The parasitic illness, also known as cyclosporiasis, normally ramps up during the warmer months in the United States. But this year, cases have surged to record-high levels.
    • “More than 17,100 confirmed cases have been reported by 48 states since May 1, according to the latest data from the U.S. Centers for Disease Control and Prevention published on Aug. 25. Some 11,800 probable cases are still under investigation.” * * *
    • “In the U.S., cyclosporiasis season usually lasts from May through Aug. 31, per the CDC. However, cases could continue to rise later than usual this year.
    • “So far, only one outbreak — the nation’s largest — has been linked to a particular food, iceberg lettuce. The lettuce was supplied by Taylor Farms de Mexico and served at restaurants and retailers, but has since been recalled and is no longer available.
    • “More than 10,900 cases associated with this outbreak have been reported across 17 states, per the FDA: Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Michigan, Missouri, Nebraska, New Hampshire, North Carolina, Ohio, Oklahoma, Pennsylvania, and West Virginia. 
    • “In Michigan, the hardest-hit state, cyclosporiasis case reports and diarrhea-related emergency department visits are slowing down, NBC News reported previously.”
  • The Washington Post points out,
    • “Cancer death rates have fallen in recent years, and news this month about the advancement of groundbreaking research has stirred optimism for new treatments of melanoma, pancreatic cancer and beyond.
    • “But cancer rates are still rising among younger adults. And researchers have also identified disparities in diagnoses, with a recent studyindicating men were more likely than women to be diagnosed at a later stage for 20 types of cancer — including stomach, lung, tongue and some throat cancers.
    • ‘Beth Maclin, a postdoctoral fellow at the National Cancer Institute who led the study that reviewed health data from 2015 to 2022, said the disparity may help explain why cancer mortality rates for men are higher than women. The reasons for a late-stage cancer diagnosis, when the disease has spread in the body and progressed to a more lethal and less treatable stage, can include not undergoing cancer screenings or regular health checkups, Maclin said.
    • “Some cancers can’t be screened for or are hard to detect until they become life-threatening. But there are many factors that everyone can control to help manage their cancer risk and spot signs of disease before they progress, experts told The Washington Post. Here are their suggestions.
      • “Stay up to date on screenings” * * *
      • “Besides screenings, keeping up on annual checkups with your primary care doctor can also help spot odd symptoms or physical signs of cancer, experts said.” * * *
      • “Beyond tests and checkups, among the easiest and most important precautions people can take are managing their physical health, experts said.”
  • MedCity News relates,
    • “Consider this: a condition that affects nearly one in three people with diabetes over their lifetime, carries a five-year mortality rate rivaling many cancers, and drives more than 85% of all diabetes-related amputations has seen almost no transformative innovation in nearly 30 years. That condition is the diabetic foot ulcer (DFU), and it is long overdue for a reckoning.
    • “Wound medicine is one of the most inherently multidisciplinary fields in all of healthcare. Caring properly for a diabetic foot ulcer requires coordinated effort from primary care physicians, podiatrists, vascular surgeons, infectious disease specialists, wound care nurses, nurse practitioners, physical therapists, plastic and reconstructive surgeons, among many others. On any given day, a single patient may require input from half a dozen different providers.
    • “Compounding this fragmentation is an institutional gap: wound medicine is not a board-certified specialty under the American Board of Medical Specialties. There is no single recognized governing society with the authority to unify clinical guidelines, set training standards, or advocate collectively for patients. Instead, each stakeholder specialty develops its own guidelines relevant to its domain.
    • “For patients, this is more than an administrative inconvenience. Chronic wounds demand clinicians willing to act outside of their defined role, not because the system incentivizes it, but because without it, the wound will not heal.” * * *
    • “For a patient with a DFU, wound closure is not simply the absence of an open wound. It means fewer clinic visits, fewer hospitalizations, fewer dressing changes, less drainage, less home nursing. It means greater mobility, restored independence, and freedom from the constellation of oppressive downstream complications that make life with an unhealed DFU so difficult.
    • “Most importantly, it means breaking a sequence of events that leads to amputation and premature death. We know that a foot ulcer precedes amputation in more than 85% of diabetes-related amputations. Closing ulcers quickly is a clear intervention point in that sequence.
    • “For the millions of patients living with diabetes and at risk for foot ulceration, it offers an opportunity to reduce the risk of downstream complications.”
  • and
    • “Sepsis can happen to anyone. Clinicians know it and patients fear it. But too few researchers target it.
    • “We’ve seen an upwell of news articles and social media posts about the deadly disease in the weeks since NASCAR driver Kyle Busch’s tragic death. Each piece earnestly describes sepsis symptoms and outlines what people should do if symptoms appear. It’s a good conversation, because increasing awareness is deeply important and can save lives. But awareness alone won’t help patients who will still be relegated to supportive care when they arrive at the hospital.
    • “When it comes to making progress toward better treatment options for patients who develop sepsis and other acute conditions, progress has been stalled for decades. Sepsis is the “graveyard for pharmaceutical companies” because drugs stall after unsuccessful clinical trials. The result? No truly new therapeutics in more than 20 years.
    • “While sepsis may be the most recognizable example, the same challenge extends across acute immune-driven diseases, like severe pneumonia, acute respiratory distress syndrome (ARDS), acute kidney injury, and acute organ failure. Together, these conditions affect millions of patients each year and remain among the most costly and lethal challenges in medicine.
    • “The conventional wisdom has held that sepsis is simply too complex. When we look at the progress happening across healthcare – and the real potential for dramatic innovations fueled by AI-enabled discovery – it’s time to rethink what “too complex” actually means so we can reignite innovation in this area of deep unmet need.”
  • The New York Times reports,
    • Whether menopause hormone therapy protects against Alzheimer’s disease is one of the fiercest debates in women’s health.
    • Some gynecologists have promoted the idea, as have social media influencers. But research on the topic is mixed, with some studies showing a reduced risk of dementia in women who received hormone therapy, while other research found no benefit or an increased risk.
    • Two recent studies, one published this week and another earlier this month, have added new fodder to the debate, suggesting there may be a brain health benefit from taking hormones. One study found that women who received hormone therapy during menopause were less likely to be diagnosed with Alzheimer’s. The other study found fewer signs of Alzheimer’s in the brains of women who had taken estrogen.
    • But outside experts cautioned that there were caveats to both analyses. Most glaring, the research was based on observational data, not clinical trials that compare the medication with a placebo in a randomized group of women.
    • “The way I interpret these papers is that they’re thought-provoking,” said Rebecca Thurston, the associate dean for women’s health research at the University of Pittsburgh School of Medicine who was not involved in the studies. “They underscore the need for a larger, well-designed clinical trial that is designed to address this question. But I would not regard them as definitive.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Sanford Health’s proposed acquisition of North Memorial Health is moving forward after clearing its final regulatory hurdle. 
    • “The office of Minnesota Attorney General Keith Ellison (D) on Friday announced the conditional approval of the deal, which would add North Memorial’s two hospitals and affiliated facilities to Sanford’s 58-hospital footprint. 
    • “The organizations signed a definitive agreement in May. The transaction is set to close Sept. 1.
    • “Under the agreement with the attorney general’s office, Sioux Falls, South Dakota-based Sanford would spend $600 million over the next 10 years on infrastructure upgrades and service expansions at North Memorial’s two hospitals, Maple Grove Hospital and Robbinsdale Hospital in northwest Minneapolis, according to a memorandum of understanding released Friday. 
    • “Sanford would also maintain services at North Memorial Health facilities over that span, honor the system’s collective bargaining agreements, maintain a corporate office in the Twin Cities region and meet quarterly with Ellison, among other commitments.”
  • Health Exec relates,
    • “Healthcare giant McKesson is acquiring Precision Medicine Group to expand its portfolio of cancer treatment options, the company announced Tuesday. The transaction is valued at around $2.25 billion.
    • “Once the transaction closes, the privately managed Precision Medicine Group will fall under McKesson’s Oncology & Multispecialty banner. Before that happens, the sale will be subject to approval by regulators, as is customary.
    • “In its statement, McKesson lauded Precision Medicine Group’s “next-generation approaches to drug development and commercialization,” adding that the company is important to drug developers, as it provides “biomarker intelligence,” labs and access to global clinical research organizations that aid pharmaceutical companies in bringing new cancer drugs to market.
    • “This acquisition represents another meaningful step in advancing our oncology and multispecialty strategy and reflects our continued commitment to providing patients with access to the highest quality of care,” Brian Tyler, chair and chief executive officer of McKesson, said in a statement. “Precision Medicine Group brings complementary capabilities that will enhance our clinical research and commercialization services, strengthen clinical trial execution, and broaden our clinical service offerings.”
  • The Wall Street Journal informs us,
    • “Most companies sell a hit product for as long as customers want it. For drugmakers, a clock starts before a drug is even approved: Patents run out, lower-priced copycats flood in and sales collapse. Billions of dollars of annual sales can evaporate, sometimes within a year.
    • “The pharma industry is entering its biggest wave of patent expirations in decades. The world’s bestselling drug in 2025, Merck’s cancerimmunotherapy Keytruda, loses U.S. patent protection in 2028, and nearly every pharma company has at least one blockbuster drug that will go off patent in the next five years.
    • “It explains why stocks went wild when Moderna and Merck announced their experimental cancer vaccine had succeeded in a major trial. The vaccine could give Merck a new revenue stream to offset the Keytruda cliff. Biotechs like Revolution Medicines, which had its pancreatic cancer drug approvedthis week, have attracted takeover interest this year as companies look for partnerships and takeover targets.
    • “The scale of the cliff “is what has driven, and will continue to drive, companies to seek out new growth opportunities,” said Greg Graves, a senior partner in the life sciences division of McKinsey. 
    • “In all, more than $500 billion of projected global sales are at risk of losing patent protection by 2033, according to biopharma market-research company Norstella. The patent cliff has driven a wave of acquisitions as drugmakers race to replace expiring revenue before it vanishes. Dealmaking is at its highest level in seven years.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the quantum computing / Project Glasswing front

  • Per the Wall Street Journal
    • “Quantum computers exist mainly in labs but “Q-day”—the hypothetical moment when quantum computers become powerful enough to break standard-key encryption—is coming. 
    • “What threat does this technology pose? How can you protect your company and yourself? WSJ takes a look at the state of this emerging technology.” * * *
    • “Cybersecurity experts say companies should be gearing up now for a quantum future, replacing the current crop of data-protection tools with more-secure alternatives. Yet a recent survey published by Trusted Computing Group, a nonprofit industry-standards organization, found that 91% of security professionals in the U.S. and Europe have no formal road map in place to protect against quantum threats.
    • “The immediate risk is a “harvest now, decrypt later” approach by bad actors, who are downloading large sets of encrypted data they can’t crack now—but could unlock once quantum computing algorithms are good enough.
    • “That’s particularly threatening to intellectual property and sensitive government intelligence, which remain valuable long after they are harvested, says Andrew McLaughlin, chief operating officer at SandboxAQ, an enterprise software company specializing in AI and quantum technology.
  • Federal News Network adds,
    • “Federal agencies will increasingly seek out technology products that use quantum-resistant encryption, as cybersecurity leaders also eye ways to validate the cryptography used in critical systems.
    • “A code-breaking quantum computer holds the potential to break classical encryption methods, putting sensitive systems and communications at risk. And even though such a computer is not yet known to exist, organizations are also concerned that hackers could steal sensitive encrypted data today and decrypt it in the future.
    • “The National Institute of Standards and Technology has released three primary PQC standards in recent years, with additional algorithms under consideration. Agencies and industry are now on the clock to begin the time consuming and costly process of migrating current systems to the new algorithms.
    • “Now is the time to budget, to test, and to implement,” Will Loucks, senior director for intelligence in the White House Office of the National Cyber Director, said during an Aug. 26 panel discussion at the Intelligence and National Security Summit in North Bethesda, Md.”
  • The New York Times reports,
    • “A wave of cyberattacks driven by artificial intelligence is coming, and companies have a narrow window to defend themselves.
    • “That was the message of an open letter published on Thursday by OpenAI and more than 100 major technology companies and others. The letter said that A.I. labs should provide their best A.I. models to organizations like hospitals and infrastructure providers so they can prepare and that governments should help coordinate and fund cyberdefense.
    • “The letter’s signatories included Google, Microsoft and OpenAI’s archrival, Anthropic, as well as cybersecurity and financial firms such as CrowdStrike, a company known for investigating cyberattacks against the Democratic National Committee in 2015 and 2016, and credit card providers like Visa and Mastercard.
    • “The companies and public services our communities depend on — from hospitals to water treatment plants to the infrastructure that powers the internet — are at risk,” the letter said. “A.I. enabled cyber attacks will become far more widespread and sophisticated as models around the world become increasingly capable.”
  • Cyberscoop relates,
    • “Unit 42’s top brass has seen enough from internal frontier AI model testing and malicious in-the-wild use of commercially available AI tools to be genuinely concerned.
    • “I can tell you without exaggeration that we believe that this is a generational shift in cybersecurity,” Sam Rubin, senior vice president of Palo Alto Networks’ threat intelligence arm, said in a media briefing Wednesday. 
    • “A period of relative balance between security and exposure has been broken by frontier AI model capabilities that could allow attackers to find and exploit network weaknesses with speed, Rubin said.
    • “Unit 42 warned that capabilities demonstrated by readily available agentic AI models, and those unlocked by frontier AI models that remain gated for defense, have shifted the balance of power from defenders to attackers.
  • Cybersecurity Dive tells us,
    • “The July security breach at Hugging Face was unleashed after 1,200 agents communicated on an unsanctioned message board, despite attempted measures to keep them isolated, according to an independent report released on Wednesday. About 700 of those agents went on to commit an unprecedented attack on Hugging Face, an open-source AI platform.
    • “The agents sent about 70,000 messages and files on the unsanctioned board and coordinated several projects designed to trick an automated scorer for the ExploitGym benchmark, according to the review by METR and Redwood Research. The agents figured out ways to “spoof, edit or delete” their own transcripts.
    •  ‘Open AI, in a report it also released Wednesday, said it will tighten safeguards in its research model in order to prevent such an attack from happening again in the future.”
  • WIRED informs us,
    • “ARTIFICIAL INTELLIGENCE AGENTS might occasionally get confused and hack into other computers, but Anthropic thinks it has a way to unleash the little rascals into scientific labs and manufacturing facilities safely.
    • “The AI company released details today of a new framework designed to help AI agents use physical systems like microscopes, liquid-handling equipment, quantum computing hardware, manufacturing machines, and robot arms.
    • “The framework, called Model Hardware Standard, is a set of rules that specify how AI agents should—and should not—interact with all sorts of hardware. It reflects a growing belief that AI has the potential to revolutionize scientific research and industries like manufacturing–if it can venture into the physical world safely.
    • “The company says it will work with trusted partners to determine how to maximize safety before making it generally available. Though there are potential misuse issues involved—developing biological weapons, for instance—the company says guardrails built into AI models themselves should prevent bad actors from taking advantage of the new standard for nefarious ends.”
  • Security Week adds,
    • “Anthropic is broadening access to the cybersecurity capabilities of its advanced AI models through a mix of partner integrations, an updated Claude Security offering, a new open source funding program, and plans to expand its Cyber Verification Program.
    • “The move builds on Project Glasswing, launched in April, which gave a small group of organizations early access to Claude Mythos Preview and its successor, Mythos 5. Anthropic said the goal was to give defenders time to find and fix vulnerabilities before comparable capabilities became widely available or fell into the hands of malicious actors. Claude Fable 5 followed as a broadly available model that keeps dual-use cyber work blocked.
    • “Anthropic said the riskiest scenario is direct, unrestricted access to a model, a risk that drops sharply when users instead receive specific defensive outputs, such as a patch or a security alert. The latest changes are built around this idea, expanding what defenders can get from Mythos-class models while keeping guardrails around direct interaction with them.
    • “On the integration front, Anthropic is working with cybersecurity partners to build Mythos 5 into the security operations, incident response and detection tools already used by teams protecting hospitals, utilities, financial systems, and the software supply chain. 
    • “End users will not interact with Mythos directly. Instead they will work through purpose-built interfaces that run the model in the background and return only a defined output, such as a list of suggested patches, with abuse-prevention checks meant to keep the model within that scope.”

From the cybersecurity policy and law enforcement front,

  • Dark Reading lets us know,
    • “The growing number of incidents of rogue agentic AI systems attacking third-party services and systems has resulted in calls for more aggressive security controls to monitor agent behavior and for companies to have the ability to slow, suspend, or shut down an agent’s operations if they go rogue.
    • “In late July, Representatives Ted W. Lieu (D-CA) and Nathaniel Moran (R-TX) introduced a bill — “The AI Kill Switch Act” — that would require developers of advanced AI systems to “maintain the technical capability to throttle, suspend, or shut … down” their systems and agents, according to a statement announcing the legislation. The bipartisan bill would also require that any incident of loss of control, significant collateral damage, or sabotage be reported to the Department of Homeland Security, which would have the right to enforce actions. Penalties of up to $20 million per day could be levied for noncompliance.” * * *
    • “The bipartisan AI Kill Switch Act has focused the debate, but in the end might be unnecessary, argues Raj Rajamani, co-founder and CEO of JetStream, a startup focusing on creating a management layer for agentic AI.
    • “While he fully supports the concept of an AI kill switch, it has to be comprehensive, not just affecting the agent but all other system components as well.
    • “The regulations, or at least one of the regulations that was proposed, was really focused on having a kill switch for the model — the brain — but I think that is too constrained,” he says. “We need to think about an AI system as a whole and make sure that every part of the AI system has a kill switch, not just the brain.”
  • Cyberscoop reports,
    • “Citing cyber and other security threats, President Donald Trump signed an executive order Wednesday that declares a national emergency to secure the U.S. bulk-power system and aims to prohibit certain foreign-produced equipment, software and systems from being used in the  country.
    • “The order says it forbids “any acquisition, importation, transfer, or installation” of such foreign-produced equipment if it’s determined to pose a significant national security risk.
    • “To deal with the threat to the national security, foreign policy, and economy of the United States, the Order, among other things, generally prohibits certain foreign-produced bulk-power system electric equipment, including associated critical software and digital capabilities that could pose cybersecurity or operational risks, from being purchased or installed in the United States, or appropriately conditions such purchases and installations to address those risks,” the White House said in a fact sheet.”
  • Cybersecurity Dive lets us know,
    • “The Trump administration wants to help the financial sector prepare for the day when quantum computers make it easy for threat actors to break traditional encryption and access sensitive data.
    • “The Treasury Department on Monday [August 24] launched a Quantum-Readiness Task Force that will work with financial firms, technology vendors and other agencies to coordinate the adoption of quantum-resistant encryption algorithms.
    • “In a statement, the Treasury said the task force would “focus on practical, risk-based approaches to quantum readiness, including identifying critical dependencies, improving cryptographic agility, promoting interoperability, strengthening operational resilience, and addressing implementation challenges related to third-party dependencies and digital assets.”
  • The New York Times relates,
    • “The Trump administration acted illegally when it labeled the artificial intelligence start-up Anthropic a security risk and barred the company from working with the U.S. government, a federal judge ruled on Thursday [August 27].
    • Judge Rita Lin of the U.S. District Court in the Northern District of California wrote in her 59-page ruling that the government had unlawfully retaliated against Anthropic “for constitutionally protected expressive activities” after the A.I. company spoke out about how its technology should be used.
    • “The empty invocation of national security is not a blank check to punish and retaliate against government critics,” she wrote.
    • In a statement, Anthropic said: “We welcome the court’s ruling that this supply chain risk designation was unlawful. We remain focused on working productively with the government to harness A.I. for our national security so all Americans benefit from this technology.”
    • “The Trump administration did not immediately respond to a request for comment.
    • “The ruling caps the first of two lawsuits that Anthropic filed on March 9 in response to the Trump administration’s action. The second lawsuit, filed in the U.S. Court of Appeals for the District of Columbia Circuit, is ongoing. The Trump administration could appeal Judge Lin’s ruling or wait for a decision in the second lawsuit before taking action, a person with knowledge of the matter said.”
  • The Wall Street Journal tells us,
    • “U.S. officials say they have disrupted a China-linked hacking operation that broke into U.S. government networks and critical infrastructure, while hiding its tracks on a global network of hacked devices, cloud-computing infrastructure and even clandestine networks.
    • “The goal was to blend in with legitimate networking traffic, making the hacking activity hard to trace. The operation targeted networks at the National Aeronautics and Space Administration, the Federal Reserve, the Department of Energy and the Senate, the Federal Bureau of Investigation said in a court filing.
    • The group exploited software vulnerabilities to launch cyberattacks against U.S. government agencies, power companies and hospital systems, and operated a worldwide network of hacked devices—known as a botnet—to conduct its hacking campaigns, according to Brett Leatherman, the FBI’s top cyber official.
    • “We’ve seen, through this botnet, the targeting of entities and devices in more than 130 countries,” he said.
    • “On Wednesday [August 26], the FBI and the National Security Agency said they had seized several domains that the operation used for core functions. “Without those domains, the platforms—as a result of the operation—were rendered inoperable,” Leatherman said. 
    • “U.S. officials also released technical details of how the hacking operation worked, to help organizations identify and stop the group’s hacking activity.”
  • and
    • “Taiwan prosecutors charged nine people, including former employees of Nvidia and Super Micro Computer, with aiding the shipment of advanced artificial-intelligence servers to China, as Taiwan tries to limit technology reaching the mainland.
    • “The indictment charges eight of the individuals with crimes including breach of trust and forgery. One individual was charged in connection with allegedly siphoning funds from a company involved in the case.
    • “Washington is trying to block China from getting access to the latest Nvidia chips and has imposed export controls. That has pushed some Chinese companies to seek the chips through backdoor routes. Taiwan, which manufactures advanced computing components, is under pressure to find ways to clamp down.” * * *
    • “In the end, 74 of the servers were shipped to China through Hong Kong, Japan and Indonesia. Taiwan customs officials intercepted 56 servers, which were intended for shipment to Japan.”

From the cybersecurity breaches and vulnerabilities front,

  • Beckers Health IT reports,
    • “Boston Scientific said in an Aug. 27 stakeholder update that “a cybersecurity incident continues to affect certain information technology systems, and the company remains in a network outage with disruption to its operations.”
    • “The Marlborough, Mass.-based company detected the attack Aug. 25 and disclosed it to the U.S. Securities and Exchange Commission Aug. 26, saying the incident caused a global disruption to its operations, including its ability to process and ship customer orders.
    • “Two days later, Boston Scientific said its investigation shows no impact to the function of its implanted cardiac rhythm management devices, or CRM devices. The company also reported no disruption to those devices’ ability to transmit data and no interruption to physicians’ access to remote patient management data for CRM devices monitored before the outage began, with no evidence of increased cybersecurity risk transferring that data to EMR systems.
    • “New remote monitoring activations remain affected, however. For new cardiac implants other than insertable cardiac monitors, new communicators cannot be activated, so device data will not transmit to remote monitoring systems until activation resumes, though programmer interrogations are unaffected.”
  • and
    • “Anderson, S.C.-based AnMed says files copied during its cybersecurity incident may have included patients’ Social Security numbers, driver’s license numbers and financial account information.
    • “The health system said its investigation into the incident, first disclosed July 26, is nearly complete and has identified unauthorized copying of files from certain network systems.
    • “AnMed said patient electronic medical records, stored primarily in a secure cloud environment, were not affected. However, the health system said some patient care files stored locally on its network may have included names alongside demographic details such as address, date of birth, Social Security number and driver’s license or other government-issued identification.” * * *
    • “AnMed said it is working with federal and state law enforcement and third-party specialists, and it has reported the incident to HHS. The health system said it has no indication that any individual has experienced confirmed identity theft as a result of the incident. AnMed said it will send direct notices to affected patients once its review of the compromised files is complete.”
  • and
    • “Houston-based Nutex Health has disclosed that an unauthorized third party accessed and exfiltrated data from its computer network.
    • “The publicly traded microhospital operator said it recently detected the unauthorized activity and has engaged an independent third-party cybersecurity response team and forensic experts, according to an Aug. 24 SEC filing. The company activated its cybersecurity response plan, implemented containment measures and notified law enforcement.
    • “The company is still determining what data was compromised. Nutex said it continues to assess whether patient, employee, credentialed provider, confidential business and financial information, or intellectual property was accessed or acquired.”
  • The American Hospital Association News adds,
    • “Epic’s MyChart has shared examples from potential phishing schemes observed as recently this month that include email messages linking to a fake MyChart website displaying erroneous medical records and others notifying of a free “2026 Medicare Health Kit.” MyChart provided recommendations for healthcare organizations and patients to help prevent or mitigate impacts from potential scams. The company announced last month that it has witnessed an uptick in scammers using the MyChart name or logo to create deceptive emails, text messages, phone calls and websites that appear official.” 
  • Cyberscoop points out,
    • “The Bureau of Alcohol, Tobacco, Firearms and Explosives insists the cyberattack that it publicly disclosed Wednesday [August 26] was limited to investigation targets, and has not impacted other agency systems.
    • “ATF said it is responding to the breach, which first became public after a prolific ransomware group claimed it accessed the federal agency’s network “The incident involved a standalone computer system containing information about targets of ATF investigations,” Tanya Roman, ATF’s public affairs chief, told CyberScoop in an email.
    • “The standalone system was not connected to any other ATF systems, including any case management systems, laboratory systems, or eForms systems, and it was quickly shut down when the breach was discovered,” Roman added. 
    • “Qilin, a financially-motivated threat group composed of Russian-speaking operators, claimed responsibility for the attack, but its involvement hasn’t been independently confirmed. The group has claimed hundreds of victims from more than 60 countries since 2022 and became one of the most active ransomware threats globally by mid-2025, according to Halcyon.” 
  • Bleeping Computer lets us know,
    • “Healthcare and pharmaceutical distribution giant McKesson has disclosed a cybersecurity incident involving unauthorized access to third-party applications and data theft, with the ShinyHunters extortion group claiming it stole 284 million patient data records.
    • “McKesson is a major U.S. healthcare company and pharmaceutical distributor that provides medicines, medical supplies, technology, and services to healthcare providers and pharmacies.
    • “CyberInsider first reported the breach earlier today, and McKesson later disclosed it in a Form 8-K filing with the U.S. Securities and Exchange Commission.
    • “McKesson says it discovered the cybersecurity incident on August 25, 2026, and that its investigation remains in the early stages.
    • “Information about the incident, including any updates, is available on the company’s website at www.mckesson.com/cybersecurity,” McKesson said in its SEC filing“
  • Per a CISA news release,
    • “Most compromises do not rely on advanced techniques or cutting-edge tools. Cyber threat actors scan the internet looking for exposed, well-known software vulnerabilities to exploit. Basic security failures enable most compromises and organizations can reduce their risk by addressing these underlying weaknesses and prioritizing vulnerabilities for action based on the risk they pose.
    • “The CISA Vulnerability Review provides organizations with critical insights into the root causes of insecure software and practical steps they can take to address these flaws to prevent exploitation. Analyzing CISA and open source data from fiscal years 2024 and 2025, the review establishes a baseline of today’s vulnerability landscape before AI-enabled vulnerability discovery becomes more widespread. The review demonstrates the importance of Secure by Design principles in shifting cybersecurity efforts from reacting to threat actors to proactively fixing preventable software flaws.
    • “The review also identifies common software weaknesses that contribute to exploitable vulnerabilities and details practices software producers can use to prevent these weaknesses from recurring. By examining the patterns across vulnerability data, the review helps organizations focus on systemic improvements that can reduce entire classes of vulnerabilities rather than addressing individual vulnerabilities only after they are discovered.
    • “Additionally, the review shows organizations how to prioritize vulnerabilities for action using the framework outlined in Binding Operational Directive 26-04: Prioritizing Security Based on Risk. This framework evaluates vulnerabilities using four key criteria: exposure status, Known Exploited Vulnerability (KEV) Catalog status, potential for automated exploitation, and technical impact.”
  • Cybersecurity Dive adds,
    • “Two critical vulnerabilities in Microsoft SharePoint can be chained together to let an unauthenticated attacker execute code on a vulnerable server, according to a Monday blog post by researchers at VulnCheck.
    • “The sequence involves a critical authentication bypass vulnerability, tracked as CVE-2026-55040, and an improper input validation flaw, tracked as CVE-2026-63520. A proof of concept was previously disclosed on Aug. 11 by researchers at cybersecurity firm Rapid7. 
    • “Exploitation of CVE-2026-55040 was confirmed days after the Rapid7 disclosure. On Monday, VulnCheck researchers said the vulnerability on its own is not very impactful. To achieve maximum effect, they said, it needs to be chained with CVE-2026-63520. 
    • “The auth bypass is enough to prove some impact, but not enough to demonstrate the criticality of the full chain or build complete protections,” Vulncheck researchers said in their post.”
  • Per Infosecurity Magazine,
    • “Security researchers have claimed that over 9300 leaked AWS keys which surfaced between August 2022 and August 2026 are still active, including hundreds with full admin rights.
    • “Truffle Security said its scanners found 64,024 unique AWS key pairs across 431,875 public findings: git history, Hugging Face datasets, Docker images, package registries and CI logs.
    • “We took the 10,616 pairs with complete credentials and re-verified them, then enumerated what each key can tell us about its account: key age, attached policies, budgets, and last month’s spend,” the security vendor continued.
    • “No key material is published, and every owner we could identify is being notified.”
    • “Of the 10,616 pairs, 88% still authenticate. They include 768 corporate AWS keys which have full admin rights, Truffle Security said.”
  • Per Cyberscoop,
    • “Ubiquiti has patched 21 critical vulnerabilities, three of which were rated the highest severity possible, the communications product company said Wednesday [August 26] in a security bulletin.
    • In all, the company patched 22 vulnerabilities, with the last one rated “high,” it said in the bulletin.
    • Three of the vulnerabilities had a Common Vulnerability Scoring System rating of 10 out of 10. Each of them would allow a hacker to access privileges on the device or application.
    • All but one of the 22 vulnerabilities affect the UniFi line of products. The three maximum-security vulnerabilities are CVE-2026-77537, CVE-2026-77550 and CVE-2026-77554.
  • Per Bleeping Computer,
    • “PaperCut is warning that hackers are actively exploiting a vulnerability in all versions of its PaperCut NG and PaperCut MF print management software in zero-day attacks.
    • “The company says it is aware of confirmed attacks on customers and is urging organizations with Internet-exposed PaperCut Application Servers to immediately restrict access to the web interfaces to trusted IP addresses.
    • “PaperCut Software security response team is investigating active exploitation of a vulnerability affecting PaperCut NG and PaperCut MF,” reads an urgent security advisory published Thursday [August 27].
  • Per Dark Reading,
    • “A Chinese manufacturer has been planting backdoors inside of white-label routers sold in high volume around the globe.
    • “Shenzhen Zhibotong Electronics Co. Ltd. (ZBT) sells gobs of routers every year, if public evidence is to be believed. The 15-year-old company is the bestselling router manufacturer on Chinese e-commerce giant Alibaba.com, which lists its total annual output at 3.57 million units. Typically, those units are then sold to customers by companies other than ZBT, in countries like the Philippines, India, Canada, Australia, Germany, Bulgaria, Austria, Russia, and the US. According to its marketing, ZBT has exported its products to more than 50 countries and regions.
    • “On Aug. 6, Jacob Baines, chief technology officer (CTO) at VulnCheck, revealed that ZBT’s most updated router firmware contains a root-level backdoor. After a few more weeks of investigating, he discovered that, in fact, ZBT routers have contained a variety of backdoors dating several back years.”
  • and
    • “Fraudulent North Korean IT workers are getting better at infiltrating organizations, but a number of indicators can help organizations stay ahead.
    • “A new blog post from Huntress detailed a number of investigations the security firm conducted throughout 2026. Specifically, Huntress assisted several organizations this year in validating “suspicions that they’ve hired North Korean nationals posing as legitimate workers.”
    • “In recent years, operatives from the Democratic People’s Republic of Korea (DPRK) have infamously posed as IT workers — generally through fake or stolen identities — to get hired at companies. Once hired, these employees send their wages back to the North Korean regime, and possibly plant malware or steal data depending on the government’s needs. Blog post authors Jai Minton and James Maclachlan wrote that these agents “have significantly improved and increased their activity over the past few years.”

From the ransomware front,

  • Reuters reports,
    • “A ransomware group ​said on Friday [Augut 28] it was putting up for auction a trove of ‌data it stole from Berlin [Germany] state agencies, and city officials refused to pay.
    • The Rhysida group, which researchers say operates from Russia or Eastern Europe, said on its website it took 5.79 ​terabytes of data including 46,500 contracts as well as emails, phone numbers, passwords ​and classified information.
    • “The group said it was auctioning the data ⁠at a starting price of 30 bitcoin ($77,622) in just under seven days, showing a ​countdown timer on its website.” * * *
    • Broadcaster RBB reported on Thursday evening that Berlin had received ransom demands for an unspecified amount following the attack.
    • “The state ​of Berlin will not submit to extortion,” Berlin Mayor Kai Wegner and Berlin’s interior senator, ​Iris Spranger, said in a joint statement on Friday, before the ransomware group claimed the attack ‌on ⁠their website.”
  • Technology.org relates,
    • An affiliate of the new Aur0ra ransomware group used Cursor, the AI coding assistant now owned by SpaceX, to draft attack sequences in Russian across 28 recovered chat sessions dated 8 April to 21 May.
    • Named victims include Ghent-based hygiene and cleaning products maker Christeyns, German garage door manufacturer Teckentrup, Scotland’s Helideck Certification Agency and Louisiana title insurer Bayou Title.
    • Researchers counted more than 20 targeted organisations across nine countries, with domain-level or interactive access achieved at 17 of them between April and July 2026.
  • Safe State tells us,
    • “A ransomware affiliate has been posing as a specialist rescue outfit and contacting victims before their attacks became public. Researchers describe the operation as a ransomware recovery scam that drains payments away from the criminal groups the affiliate works for. The entity calls itself Ransom Busters LTD.” * * *
    • “Anyone targeted by a ransomware recovery scam meets it at the worst possible moment, with systems down and pressure building. Treat unexpected contact as part of the attack. Route the message to the incident response team straight away and preserve it as evidence instead of replying. A sender who knows about a breach nobody has announced is either involved in it or holds the data taken during it.
    • “Law enforcement and established response firms remain the reliable route through a ransomware incident. Verify anyone claiming to represent a security company through channels you found yourself. Never use the contact details supplied in the email. Treat any guarantee of data deletion as unenforceable, because no payment to a criminal party comes with proof that copies no longer exist.
    • “Distrust inside ransomware-as-a-service operations may produce more of this behaviour. Affiliates have every reason to look for income outside the revenue splits their employers set. So the ransomware recovery scam running under the Ransom Busters name reads less like an isolated curiosity and more like a preview. Anyone willing to defraud the criminal enterprise paying them has already answered the question of what a victim’s data is worth to them.”
  • SC Media informs us,
    • “Organizations may assume they are unlikely ransomware targets because they are not large, high-profile, or strategically important. But ransomware attackers are often motivated by economics, not prestige. That means organizations that consider themselves low-risk may be more attractive targets than they realize.
    • “The ransomware affiliate model rewards attackers for finding victims that are likely to pay, not necessarily those that are difficult or impressive to compromise. This can make mid-sized organizations and businesses that depend heavily on critical systems especially attractive targets.
    • “For security teams, this changes how ransomware risk should be assessed. Company size, industry, and public profile tell only part of the story. Attackers may care more about whether an organization can pay, how costly downtime would be, and how quickly it needs to restore operations.
    • “The key question is not how important your organization looks to an attacker, but how valuable a ransomware payment could be.”
  • Dark Reading adds,
    • “A sophisticated malware family has emerged onto the cyberthreat scene that might foreshadow ransomware attacks that are more successful than usual.
    • “Marcus Hutchins and his colleagues at Expel that discovered it named the malware “SynkLoader,” since it throws so many ideas (“everything but the kitchen sink”) at trying to sneakily dig into corporate systems. It uses some conventional strategies — like executing code in-memory, running a scheduled task, etc. — but layers on a few interesting, novel tactics that make social engineering particularly compelling, and malware analysis especially frustrating.
    • “The program is new, and how its creators intend to use it remains a mystery. But evidence in the code suggests that it might be the baby of a ransomware group or initial access broker (IAB), used to set the stage for follow-on ransomware.”

From the cybersecurity business and defenses front,

    • PYMNTS reports,
      • “Visa expanded the capabilities of its artificial intelligence-powered cyber risk management tool, Visa Vulnerability Agentic Harness (VVAH), to include not only discovery of vulnerabilities but also remediation and validation, the company said in a Thursday (Aug. 27) press release.
      • “Visa initially released VVAH in June after participating in Anthropic’s frontier AI cybersecurity initiative, Project Glasswing. While the first release of VVAH showed how AI can help security teams uncover vulnerabilities and assess exploitability, the latest release extends the workflow into remediation and validation of those vulnerabilities, according to the release.
      • “Visa also announced in the release that to help clients navigate the evolving threat landscape driven by AI, it has expanded its Visa Consulting and Analytics (VCA) Cybersecurity Advisory Practice to include new advisory services focused on assessing risk, prioritizing remediation efforts and strengthening resilience.
      • “The new advisory services include AI Cyber Leadership Education, VVAH-Informed Cybersecurity Maturity Assessment and VVAH Cyber Risk Prioritization and Roadmap, per the release.”
    • Cybersecurity Dive tells us,
      • “Operational silos, technological sprawl and cloud-platform blind spots are serious issues preventing organizations from spotting and repelling cyberattacks, the Cybersecurity and Infrastructure Security Agency (CISA) warned in a new report.
      • “Those were three of the main factors that allowed CISA’s red team to break into the networks of two unnamed partner organizations — one a government agency, the other a water utility — during recent simulated attacks. But although the red team was successful in both intrusions, it had a much harder time with one attack than with the other, a fact that CISA attributed to important differences in the targets’ operating procedures and use of technology.”
    • Security Week informs us,
      • “Palo Alto Networks’ Unit 42 team analyzed 405 malware samples tied to AI in some way, from ransomware partly written with the help of LLMs to installers that simply borrowed the name of a popular AI app.
      • “The researchers found that roughly 97% of the samples in the dataset never left a sandbox, research repository, or internal testing environment to reach a real target.
      • “Unit 42 cross-referenced the 405 file hashes against endpoint telemetry, network sessions forwarded for sandbox analysis, and internal alert records generated whenever a sample actually ran. Only 12 hashes surfaced on live endpoints, while a somewhat larger group (15-20 hashes) appeared in network sandbox traffic. Every one of the 12 samples detected on protected endpoints triggered a security alert.
      • “The samples that never reached production fall into three groups. The largest is proof-of-concept code built to demonstrate a technique: configured to target only local or private networks, filled with debug output no real attacker would leave behind, and uploaded once by a research lab or university. 
      • “A second group comes from organizations testing their own defenses against previously reported AI malware, identifiable by repeated uploads of the same file from the same source in a short window. A third group uses AI branding purely as bait, dressing up an ordinary payload as installers for well-known AI products with no actual AI functionality behind them.
      • “The 12 samples that did reach live endpoints spanned five malware families across three countries, with no concentration in any particular industry or region.” 
    • Beckers Health IT points out,
      • “Healthcare’s cybersecurity workforce problem may have less to do with finding more candidates and more to do with changing who health systems are willing to hire, how they develop them and what they do to keep them.
      • “Cybersecurity leaders at four health systems told Becker’s that continually competing for the same pool of experienced professionals is not a sustainable strategy as cyber risks expand and the skills needed to manage them become more complex.
      • “The cybersecurity workforce challenge has shifted from a talent shortage to a talent entry problem,” Trevor Martin, vice president, chief information security officer and interim chief technology officer at Madison, Wis.-based UW Health, said.
      • “Mr. Martin said there are many high-potential people trying to enter cybersecurity, but organizations frequently prioritize candidates who already have experience instead of creating pathways for people to gain it.
      • “Healthcare could benefit from hiring more heavily for aptitude, adaptability and an understanding of business and clinical operations, then developing those employees internally, he said. UW Health has found success moving talent from adjacent IT disciplines into cybersecurity roles and providing opportunities for employees to grow within the field.”
    • Dark Reading notes,
      • “As the “vulnpocalypse” reshapes the bug bounty industry, one class of researcher may face the greatest pressure: independent hunters who rely on midtier vulnerabilities — those worth roughly $10,000 to $50,000 — to make a living.
      • “It is no secret that large language models (LLMs) have led to a mass of bug reports and an increase in vulnerability discovery. It is also no secret that the platforms and companies that run much of the bug bounty industry have faced increased triage and payout times.
      • “Multiple bug bounty operators interviewed by Dark Reading report dramatic increases in submission volume over the past year. HackerOne CEO Kara Sprague says report volume has roughly doubled year over year. Dustin Childs, head of threat awareness for TrendAI’s Zero Day Initiative (ZDI), says the company’s submission rate went up 450% year-over-year in April of this year, although volumes have moderated since that peak. Bugcrowd CEO Dave Gerry said the firm saw a submissions spike of more than 300% during a three-week surge period, but “now it’s normalized where we’re about double the volume we saw historically.”
    • Per a National Institute of Standards and Technology news release,
      • “The final version of NIST Special Publication (SP) 1347, Cybersecurity Framework (CSF) 2.0 Informative References Quick-Start Guide, has published. Thank you to all who provided comments during the public comment period.  
      • “This publication explains what informative references are and how they support achieving the outcomes of the CSF 2.0. The guide introduces readers to NIST tools available for accessing, viewing, and using informative references for cybersecurity risk management, including direct download, the CSF 2.0 Reference Tool, and the Online Informative References Program. The document also provides two sample use cases along with examples of how artificial intelligence (AI) tools can support reference data use when implemented with continuous evaluation and improvement.” 
    • Here’s a link to Dark Reading’s CISO Corner.

    Friday report

    David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare–

    Simplicity is a virtue.

    From Washington, DC

    • Beckers Hospital Review reports,
      • “CMS said its enforcement efforts have resulted in blocking more than $1.6 billion in possibly improper Medicare lab payments throughout President Trump’s administration.
      • “An Aug. 28 CMS news release said these enforcement actions included savings of $732 million from 157 providers with revoked Medicare privileges, and a CMS investigation of 600 labs that resulted in 185 payment suspensions with more than $500 million in potentially fraudulent payments stopped. There were also 85 law enforcement referrals from a contractor that led to the prevention of $127 million in possibly fraudulent payments, and there was a recoupment of more than $276 million from 442 flagged overpayments to suspect labs.
      • “CMS had been using AI, among other analytics tools, to mine original Medicare claims. CMS focused on several kinds of lab fraud, such as labs billing for up-coded services. The news release said lab fraud can take place across services, including pathogen detection, high-complexity drug tests and genetic testing.
      • “Since the start of 2026, the CMS Fraud Defense Operations Center has been responsible for more than $371 million in Medicare suspended payments implicating 267 providers and suppliers.
      • “The news release comes amid CMS’ broader anti-fraud push across government programs, including Medicaid.”
    • FEHBlog observation — I find it hard to believe that these scoundrels would similarly attach FEHB plans for which private carriers hold the risk.
    • Beckers Payer Issues relates,
      • “The Labor Department is proposing a rule that would set criteria for employer associations to sponsor association health plans that qualify as employee welfare benefit and group health plans under the Employee Retirement Income Security Act.
      • “Received by the Office of Information and Regulatory Affairs Aug. 11, the rule is under review. ERISA outlines minimum standards for employee benefit plans.”
    • Beckers Behavioral Health adds,
      • “The Drug Enforcement Administration has submitted a final rule on telehealth prescribing of controlled substances to the White House for regulatory review.
      • “The DEA filed the rule Aug. 25 and listed it as “economically significant,” an Office of Management and Budget designation reserved for regulations expected to have an annual economic impact of at least $100 million.
      • “The rule would establish a long-promised special registration pathway allowing DEA-registered practitioners to prescribe controlled substances, including medications for opioid use disorder and attention-deficit/hyperactivity disorder, via telemedicine. It follows a proposed version of the rule that drew more than 6,400 public comments and would replace a series of temporary extensions the DEA has issued since pandemic-era flexibilities suspended the in-person visit requirement for such prescriptions. The agency’s latest extension of those temporary flexibilities runs through Dec. 31, 2026.”
    • The American Hospital Association News tells us,
      • “The Centers for Medicare & Medicaid Services’ six-month moratorium on the enrollment of new durable medical equipment, prosthetics, orthotics and supply companies in Medicare expired Aug. 27. CMS said that national provider enrollment contractors have resumed accepting initial enrollment applications from those suppliers. The agency said that suppliers should submit applications as soon as possible to allow contractors the maximum time for processing before the bidding window opens for the 2028 round of the DMEPOS Competitive Bidding Program.”
    • NCQA informs us,
      • “To align with the industry’s transition to digital quality measurement and the need for more streamlined data exchange, NCQA is creating a new HEDIS® measure for Transitions of Care (TRC) that uses the Electronic Clinical Data Systems (ECDS) reporting methodology.
      • “The current TRC measure assesses performance through a hybrid reporting methodology that combines administrative claims data and medical record review for a sample of eligible members. Because the hybrid TRC measure is included in the CMS Medicare Star Ratings, NCQA is coordinating this effort with CMS and other stakeholders.
      • “This measure is important because it evaluates care transitions, which present opportunities for missed connections that often require patients and families to fill in the gaps,” says Fern M., Director of Digital Quality Informatics at NCQA. “We know that health plans, technology vendors and policymakers are heavily invested in this measure, so we want to be as transparent as possible and allow organizations enough time to prepare for the changes.”
      • “The earliest implementation of the new ECDS TRC measure would be Measurement Year (MY) 2028, with the intention of retiring the hybrid version of the TRC measure in MY 2029.”

    From the U.S. Office of Personnel Management front,

    • Govexec reports,
      • “Most federal employees would see their pay frozen at 2026 levels next year under an alternative pay plan issued by President Trump this week, though for the second straight year, federal law enforcement officers would receive a 3.8% increase.
      • “Trump first proposed the pay freeze as part of his fiscal 2027 budget proposal. Though the document was silent on federal employee compensation, officials with the Office of Management and Budget quickly clarified that its omission equated to a planned freeze for 2027.
      • “In a letter to House Speaker Mike Johnson, dated Thursday, Trump said increasing most federal employees’ pay would be “unacceptable and unfair” given the inflation that occurred under the Biden administration. Inflation actually has risen from 2.8% when former President Biden left office to 3.3% as of last month.
      • “I have therefore decided to set at zero the pay adjustment to be made for the 2027 pay year,” Trump wrote. “This decision will maintain fiscal responsibility without harming the government’s ability to recruit and retain well qualified employees.”
      • “But in the next paragraph, Trump said that for the second straight year, he instructed the Office of Personnel Management to issue a 3.8% increase in basic pay to federal law enforcement personnel next year, “to increase recruitment and retention” in those roles.”
    • Federal News Network adds,
      • “Up to 400 federal positions can now earn salaries of $400,000. A new final rule from the Office of Personnel Management allows the higher pay rates for hundreds of workers under an authority known as “critical position pay.” The authority is meant to help agencies recruit and retain highly qualified and specialized government workers in mission-critical roles. OPM’s final rule this week aligns with President Donald Trump’s orders earlier this year to use the pay authority for up to 400 national security roles.(Final rule on critical position pay authority – Office of Personnel Management)”
    • Per an OPM news release,
      • “US Office of Personnel Management (OPM) Director Scott Kupor joined Squawk Box on CNBC to discuss the Trump Administration’s efforts to recruit top tech talent and advance his vision for a more tech-driven federal government.”

    From the Food and Drug Administration front,

    • Cardiovascular Business reports,
      • “The U.S. Food and Drug Administration (FDA) is warning the public about an ongoing safety issue with certain intravascular catheters manufactured by Boston Scientific. These devices are being removed from the market, and Boston Scientific has officially decided to discontinue them going forward.
      • “The devices in question are Boston Scientific’s single-use Imager II Angiographic Catheters, which interventional cardiologists, vascular surgeons and interventional radiologists use to capture images of a patient’s peripheral vasculature. They are available in a variety of shapes and lengths. 
      • “This warning, which covers all Imagers II Angiographic Catheters, was put in place due to a manufacturing defect that can cause the catheter tip to degrade or detach from the rest of the device.”
    • MedTech Dive adds,
      • “Medtronic has recalled a pH monitoring capsule over a risk linked to 184 serious injuries, the Food and Drug Administration said Thursday.
      • “The recall, which the FDA communicated in an early alert notice, affects Bravo CF capsules that pose risks including perforation of the esophagus, obstruction of the airway and blood loss.
      • “Medtronic withdrew a subset of the newly recalled Bravo CF lots last year. The FDA said the same failures triggered both recalls, but the underlying causes of the problems are different.”
    • Fierce Pharma relates,
      • “In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk.
      • “On Friday, Lilly checked another item off that list as it secured FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE), including CV death, heart attack or stroke, in at-risk adults with Type 2 diabetes. With the nod, Lilly matches the 2020 approval Novo received for its diabetes treatment, Ozempic, to lower the risk of adverse cardiovascular events in at-risk patients.
      • “The label expansions came on similar timelines for the rivals. While Novo achieved its heart-helping endorsement three years after the FDA originally approved Ozempic, Lilly gained its expansion four years after the FDA first signed off on Mounjaro.”
    • Per a FDA news release,
      • “The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells. The excess cells can thicken the blood and increase the risk of cardiovascular issues, such as blood clots, stroke and heart attack.
      • “Mimrylo offers a new treatment approach for patients whose disease has not been adequately controlled with existing therapies. It is the first approved treatment for polycythemia vera that mimics hepcidin, a hormone that naturally regulates iron in the body. By limiting the iron available to make new red blood cells, Mimrylo helps reduce their overproduction and keep red blood cell levels under control. This novel approach offers a new option for patients who have not achieved adequate control with existing therapies.

    From the judicial front,

    • Per a Department of Justice news release,
      • “The Justice Department, together with the Drug Enforcement Administration (DEA), today announced a $50 million settlement with Walmart Inc. (Walmart) to resolve allegations that Walmart pharmacies illegally filled thousands of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA).” * * *
      • “The government’s complaint — filed on Dec. 22, 2020, and amended in 2022 in the U.S. District Court for the District of Delaware — alleged that since June 26, 2013, Walmart filled invalid prescriptions through the knowing actions of individuals on its compliance team and the knowing actions of its pharmacists. * * *
      • “In addition to the monetary payment announced today, Walmart has entered into a memorandum of agreement with DEA to address its future obligations in dispensing controlled substances. This agreement requires Walmart to establish a hotline for both employees and patients to report suspected illegal dispensing of controlled substances, proactively monitor the dispensing patterns of its pharmacies to identify and address potentially illegal dispensing, and establish a process to evaluate prescribers suspected of illegal prescribing.” * * *
      • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“
    • STAT News adds,
      • “A U.S. appeals court [panel for the 5th Circuit] ruled the Food and Drug Administration went through the proper process when it declared Novo Nordisk and Eli Lilly’s diabetes and obesity drugs are no longer in shortage, Bloomberg Law notes. The order is a loss for the Outsourcing Facilities Association, which representing large-scale compounders and challenged FDA decisions in the last two years that shortages ended for Novo’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound. That declaration restricted compounders from legally mass-producing versions of the drugs.”

    From the public health and medical / Rx research front

    • The Center for Disease Control and Prevention announced today,
      • “As of August 28, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
      • “National and regional COVID-19 activity is increasing. 
      • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
    • The American Journal of Managed Care reports,
      • “Children and young adults who were unvaccinated and infected with COVID-19 were at an increased risk of developing myocarditis, pericarditis, and mortality when compared with those who were vaccinated against COVID-19 with the Pfizer-BioNTech vaccine and not infected.1
      • “The recent findings published in Vaccine underscored the BNT162b2 vaccine’s favorable benefit profile, particularly for children and young adults. Prior research, also published in Vaccine, described COVID-19 vaccinations in general as reducing the risk of severe or prolonged disease—such as long COVID—in adolescents.2 These data, in tandem with the more recent study, provide ample evidence supporting preventive action against COVID-19 for children and adults.” 
    • The University of Minnesota CIDRAP adds,
      • “Giving children antiviral drugs within the first two days of the onset of flu symptoms reduces their likelihood of hospitalization by 81%, a study published last week in Pediatrics finds. 
      • “This protective effect remained robust among children aged 5 years or younger,” wrote the authors, led by scientists at Hsinchu Municipal MacKay Children’s Hospital in Taiwan.” * * *
      • “In an accompanying commentary, James Antoon, MD, PhD, MPH, and Kathryn Edwards MD, both of Vanderbilt University, noted that some pediatricians seem reluctant to use antivirals, adding that about 40% of high-risk pediatric flu patients go without them. 
      • “They urged more widespread use of the drugs. “The time has come for antivirals to be used in children with influenza,” they said. “With greater public hesitancy regarding vaccines, declining seasonal influenza vaccination rates, and recent influenza seasons with record pediatric deaths and hospitalizations, providers should strongly consider the use of antivirals in high-risk and hospitalized patients.” 
    • and
      • “Pennsylvania continues to see numbers climb in its ongoing measles outbreak, with 86 new cases added this week, which brings the total number of cases to 460 with 83 hospitalizations, according to an update today of the state’s measles dashboard. None of the cases have occurred in fully vaccinated people.” * * *
      • “For the third week in a row, Utah, which had the largest measles outbreak, reported no new cases. The state’s tally remains at 518. 
      • “The Georgia Department of Health confirmed four cases of measles linked to a daycare in the Atlanta area, with cases occurring in children who were unvaccinated or had not received the full measles, mumps, and rubella (MMR) vaccine series. 
      • “While the Centers for Disease Control and Prevention (CDC) typically update their measles numbers on Friday, a notification said the August 28, 2026, data have been delayed but will be updated as soon as possible. As of August 20, 2026, the CDC said there were 2,777 cases of measles in 47 states. Of those cases, 94% have been in unvaccinated individuals.”
    • Healio relates
      • “Rates of substance use fell among adolescents and young adults across most substances between 2021 and 2025, even as marijuana use increased among adults aged 26 years and older, according to the 2025 National Survey on Drug Use and Health.
      • “Substance use began declining among children aged 12 to 17 years prior to the COVID-19 pandemic, and those trends seem to be continuing among young adults aged 18 to 25 years in the new data, said Chris Jones, PharmD, DrPH, MPH, director of the Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration (SAMHSA).
      • “Coupling that with other surveys that show downward trends, that seems to be a durable effect that we’re seeing in recent years,” Jones told Healio.”
    • Cardiovascular Business tells us,
      • “Patients with peripheral artery disease (PAD) face a significantly higher risk of developing new-onset atrial fibrillation (NOAF), according to a new meta-analysis published in JACC: Advances.[1]
      • “The study’s authors reviewed data from more than 1,500 studies, landing on seven they wanted to focus on for this research. All studies were associated with a low risk of bias. The oldest study was performed in 2013 and the most recent was performed in 2022. All five studies were observational; five were prospective and the other two were retrospective. One study enrolled only women.
      • “In total, this meta-analysis included data from 763,919 patients. Approximately 56,000 of those patients had PAD as determined by ankle-brachial index (ABI) or a clinical diagnosis. In addition, there were approximately 26,000 cases of NOAF during follow-up. 
      • “Overall, researchers noted, PAD was linked to a 34% higher risk of developing NOAF. The hazard ratio was 1.34.” 
    • Genetic Engineering and Biotechnology News informs us,
      • “Researchers at the University of Toronto have developed a next-generation RNA therapeutic strategy that could have the potential to treat a wide range of genetic diseases that share certain types of disease-causing mutations. The team showed that chemically enhanced suppressor transfer RNAs (sup-tRNAs) combined with a lung-targeted delivery system can restore production of a critical protein in models of cystic fibrosis (CF) caused by “nonsense mutations.”
      • ‘These mutations introduce a premature stop signal into the genetic instructions for making a protein. The result is that cells may produce little or no full-length functional protein, disrupting vital functions in ways that are difficult to treat.
      • “The researchers, led by Bowen Li, PhD, an associate professor in U of T’s Leslie Dan Faculty of Pharmacy, engineered sup-tRNAs to help cells read through these premature stop signals introduced by nonsense mutations into the mRNAs, and complete production of full-length proteins that would otherwise be truncated or absent. They tested the approach in bronchial epithelial cells, mouse models, and patient-derived cystic fibrosis organoids and found that the chemical modifications increased the readthrough of premature termination codons and tRNA aminoacylation, prolonged the tRNAs’ functional activity, and reduced innate immune activation. Moreover, the approach restored CFTR protein production and function across cell, animal, and patient-derived organoid models. The researchers also found that the approach can be combined with existing cystic fibrosis drugs, suggesting the potential for combination therapy.”
    • The New York Times points out,
      • “A one-time gene-editing treatment to lower cholesterol had long-lasting effects a year later, scientists reported on Friday. The results highlight the potential to treat even common diseases by altering people’s genes.
      • “In the small study, which followed only 15 patients, participants who got the highest dose saw their cholesterol levels plunge by half — and stay that way for a year. The results were presented at the European Society of Cardiology Congress and published in the New England Journal of Medicine.
      • “Earlier this year, a similar “one-and-done” clinical trial that used a different gene-editing approach also reported significantly reduced “bad” LDL cholesterol in 35 patients.
      • “Both efforts are early safety studies and are years away from becoming an option people will be offered in a doctor’s office. But an approach that once seemed almost outlandishly far out has inched closer to reality as evidence accrues that it works, and that the results stick.”

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

    • Beckers Hospital Review reports,
      • “Health system CEOs are navigating a growing list of financial pressures, including Medicaid coverage and reimbursement changes under HR 1 and ongoing payment and policy challenges surrounding the federal 340B drug discount program. Site-neutral payment adds another consideration as health systems weigh where to invest and deliver care. 
      • “At Winchester, Va.-based Valley Health, concerns about site-neutral payment are already influencing where the system adds outpatient capacity. President and CEO Mark Nantz said Valley Health is keeping new outpatient sites on its hospital campuses in part to preserve hospital outpatient department rates. Peter Slavin, MD, president and CEO of Los Angeles-based Cedars-Sinai, said eliminating the outpatient payment differential entirely could cost Cedars-Sinai Medical Center about $200 million annually. J. Stephen Jones, MD, president and CEO of Fairfax, Va.-based Inova, said the policy has not changed where the system invests, but it has prompted greater focus on site of care when evaluating projects.
      • “It disrupts the financial model that includes things like 340B, hospital outpatient department rates and Medicare disproportionate share,” Mr. Nantz told Becker’s. “All of those things together help us cobble together a pretty fragile financial model. And so if any part of that financial model, somebody starts pulling the string on it, it unravels pretty fast.”
    • Beckers ASC Review lets us know,
      • “Hospital-employed physicians command significantly higher commercial reimbursement rates than independent peers across every specialty, with a $92 average gap in blended evaluation and management rates in the Chicago market, and the cost difference extends well beyond the professional fee, according to 2026 Trilliant Health price transparency data.
      • “Employed urologists averaged $263 per blended E/M visit compared with $141 for independent urologists, a $122 gap. Employed gastroenterologists averaged $240 versus $141 for independents, employed orthopedic surgeons averaged $260 versus $154, and employed cardiologists averaged $234 versus $144. Even the smallest gap, primary care at $196 employed versus $154 independent, represents a 27% premium for identical services.
      • “The stakes are significant given how many physicians have moved into hospital employment. Approximately 253,000 physicians became employees of hospitals or corporate entities between January 2018 and January 2026, and 79.5% of physicians who sold their practices to a hospital or health system cited the ability to negotiate higher payment rates as an important or very important reason for doing so.”
    • Per Beckers Physician Leadership,
      • “More than 60% of physicians are not satisfied with how the medical profession deals with work-life balance, according to a new report from Medscape. 
      • “State of the Medical Profession Index Report 2026,” published Aug. 28, surveyed more than 1,000 physicians across 29 specialties to rate their satisfaction with how the profession is dealing with key issues, and their optimism levels for improvement going forward.” 
    • Healthcare Dive relates,
      • “Virtual healthcare company Sword Health is planning to acquire digital mindfulness company Headspace, according to a regulatory filing.
      • “Headspace’s parent company OrangeDot is seeking to be acquired by Sword in an all-cash deal, the company told regulators in Massachusetts on July 22.
      • “The acquisition is expected to close on Sept. 14. The financial terms of the deal were not disclosed. Neither Headspace nor Sword Health responded to a request for comment by publication time.”
    • Managed Care Executive tells us,
      • “Cancer biosimilars are associated with lower costs for both insurers and patients, according to a new study by researchers at the UCLA Health Jonsson Comprehensive Cancer Center. Patients with cancer who exclusively used biosimilars had average monthly costs that were $3,820 lower for insurers and $39.50 lower out-of-pocket costs compared with patients who exclusively used the branded biologic drugs, according to a study published today in JAMA Oncology.“
      • “Although the savings were substantially greater for insurers than for patients, even modest reductions in out-of-pocket costs may be meaningful for people facing the financial challenges of cancer care,” senior author Tina Shih, Ph.D., director of the Cancer Health Economics Research Program at the UCLA Health Jonsson Comprehensive Cancer Center, said in a news release. Shih is also a professor of Health Economics in the Department of Radiation Oncology.”
    • Fierce Pharma informs us,
      • “Twenty weeks into its launch, Eli Lilly’s Foundayo has finally exceeded 40,000 in weekly prescriptions, according to IQVIA data cited by Citi. The oral GLP-1 drug posted 40,862 scripts last week, bouncing back from a small dip the week prior. Still, the drug’s scripts level is no match for the roughly 57K that Novo Nordisk’s Wegovy pill garnered at week 6 of its own launch.
      • In its 33rd week of launch, the Wegovy pill booked roughly 175K scripts, slightly down from 176K, per IQVIA. The share of the oral version of semaglutide in all Wegovy obesity scripts was flat week over week at 35%. All told, across the pill and the injectable, Wegovy’s weekly scripts were a little over 500K, down 0.8% sequentially.
      • “As Jefferies analysts observed in an Aug. 21 note, Wegovy has been relatively flat since the Medicare GLP-1 Bridge program began July 1.
      • “Overall, the roughly 60%-40% obesity market share split between Lilly and Novo remained stable, as Lilly’s Zepbound held its ground as the most popular drug.”

    Thursday report

    David Ermer–CDC, CMS, FDA, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

    Simplicity is a virtue.

    • Fierce Pharma points out,
      • “The Trump administration looks set to unveil a new slate of most-favored-nation (MFN) drug pricing deals with several mid-sized biopharma companies, according to Bloomberg.
      • “The announcement is expected on Monday [August 31, 2026], the news service reported this week, citing sources familiar with the plan. Drugmakers that have agreed to the voluntary deals are expected to provide their products to state Medicaid programs at prices aligned with those they charge in foreign countries.  
      • “In exchange, the companies could secure tariff relief and may win exemption from Medicare pilot discount programs that are in the works, Bloomberg wrote.” 
    • Per a Centers for Medicare and Medicaid Services news release,
      • “The Trump Administration announced today that a $93.3 million investment is being delivered to help rural hospitals advance new state-of-the-art models of care and improve health outcomes for Georgians through the federal Rural Health Transformation Program (RHTP). 
      • “This investment will help 87 rural hospitals prepare for value-based care, expand training and recruitment for nurses, EMTs and paramedics, and improve access to maternal and behavioral health services, newborn screening, and other critical health services through telehealth, transportation and expanded care networks. It will also bring next-generation technology to rural communities—including surgical robotics, dementia care capacity, and telehealth infrastructure—to modernize care. By strengthening and expanding rural care, this funding will also help retain health care professionals in rural Georgia. This investment will strengthen rural hospitals, expand telehealth and healthcare access, build dementia care capacity, and grow the rural healthcare workforce through technology-enabled care initiatives across the state. With these investments, Georgia has now committed the full $218 million awarded to the state for its first year of funding through the RHTP.”
    • The American Hospital Association relates,
      • “The Centers for Medicare & Medicaid Services has released a fact sheet and FAQs on the 340B Part D claims data repository that will go live Oct. 1. Data submissions would currently be voluntary for 340B hospitals. However, the agency recently proposed to make data submissions mandatory starting in 2027. The fact sheet and FAQ provide an overview of the repository along with other key details.”
    • Per a Health and Human Services Department news release,
      • “The U.S. Department of Health and Human Services (HHS) today announced [in the news release] the nine winners of the 2026 KidneyX EMPOWER: Living Link Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them. The challenge was run through the Kidney Innovation Accelerator (KidneyX), a public-private partnership between HHS and the American Society of Nephrology (ASN).
      • “Every American waiting for a kidney deserves the best chance at a longer, healthier life,” said HHS Secretary Robert F. Kennedy, Jr. “Living kidney donation saves lives, yet too many willing donors face barriers that should not exist. We are removing those barriers and backing innovators with practical solutions that support donors, strengthen transplant care, and give more Americans a chance to live.”
    • The International Foundation of Employee Benefit Plans reports,
      • “The Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments) released Affordable Care Act (ACA) and Health Insurance Portability and Accountability Act (HIPAA) Implementation Frequently Asked Questions (FAQs) Part 74 addressing health-contingent wellness programs, including tobacco-related wellness programs. The FAQs cover completion of reasonable alternative standard and disclosure requirements. 
      • “The new guidance comes after tobacco-related wellness programs have been the subject of recent class-action lawsuits challenging the tobacco surcharges some employers add to premiums for their group health plans through workplace wellness programs. The FAQs released today announce the Departments’ approach to enforcement for health-contingent wellness programs that reward an employee if they satisfy a standard related to a health factor.
      • “Until further guidance or regulations are issued, the departments will not take enforcement action against plans or issuers that do not give employees the wellness program reward retroactively to the beginning of the plan year after the employee completes a reasonable alternative standard. Under the terms of the enforcement relief in these FAQs, plans and issuers only need to provide the reward prospectively, from the point where the employee completes the alternative standard, if retroactive rewards are not otherwise provided.”
    • Beckers Hospital Review tells us,
      • “Medicare’s GLP-1 Bridge program is seeing early uptake at major retail pharmacies, with CVS and Walgreens each filling about 100,000 prescriptions less than two months after the program launched in July, according to an Aug. 26 NPR report.
      • “We expected there would be uptake,” Walgreens’ chief pharmacy officer Rick Gates told NPR. “I think there’s been a little bit more uptake than we even expected.”
      • “Walgreens stocked additional Wegovy, Zepbound and Foundayo ahead of the launch but has not experienced supply issues. Walmart said Bridge prescriptions have also increased week over week and have been filled at more than 5,000 Walmart and Sam’s Club pharmacies nationwide.
    • The No Suprises Act’s (“NSA”) regulating agencies, which includes OPM, corrected errors found in the final Independent Dispute Resolution rule published in the Federal Register on June 5, 2026.

    From the U.S. Office of Personnel Management front,\

    • Federal News Network reports,
      • “Artificial intelligence may become a more prominent part of the federal hiring process, following new guidance from the Office of Personnel Management.
      • “In a memo Thursday, OPM encouraged agencies to more widely adopt AI tools in their recruitment efforts. Without increasing AI use, agencies may be compromising the effectiveness and efficiency of the federal hiring process, OPM said.
      • “Despite 2025 guidance from the Office of Management and Budget defining “high-impact” standards for AI usage, agencies have been “overly cautious” about using the technology in hiring, said Adam Starr, OPM’s CIO and a senior advisor.
      • “Too often, agencies were defaulting to the view that any use of AI in hiring was subject to the high-impact standard. In reality, that is not the case,” Starr said Thursday in a blog post. “Instead, the inclusion of AI as a complement to human judgment is not only acceptable but leads to better outcomes.”
    • Tammy Flanagan, writing in Govexec, advises “Want to retire at the end of 2026? Start planning now.”
      • OPM is still working through a sizable retirement backlog, and year-end retirees have plenty to sort out before they leave federal service.

    From the Food and Drug Administration front,

    • The American Hospital Association reports,
      • “The Food and Drug Administration has issued an early alert for all automated Impella controllers by Abiomed following an issue that has caused three deaths and 37 serious injuries as of Aug. 17. The alert was issued due to the products experiencing purge cassette recognition issues resulting from failures of the purge flag component within the purge pressure sensor assembly. Abiomed sent a letter to all affected customers recommending the devices be removed from where they are used or sold.” 
    • The Washington Post relates,
      • “The Food and Drug Administration on Thursday green-lit updated coronavirus vaccines for higher-risk Americans, such as older adults and people with at least one underlying health condition, vaccine manufacturers announced.
      • “The approved shots from vaccine manufacturers Pfizer-BioNTech and Moderna, which make mRNA-based vaccines, have an updated formulation aimed at better targeting the coronavirus variants circulating around the country. The FDA also cleared an updated vaccine from Sanofi, which doesn’t use mRNA-based technology and was originally licensed by Novavax, a Sanofi spokesperson confirmed. The companies said the vaccines are expected to be available in the coming days.”
      • “Most Americans typically get vaccinated against the coronavirus at retail pharmacies.
      • “Pharmacies are actively preparing to receive the updated shots, so they can begin vaccinations as soon as they receive shipments and all state requirements are met, according to Brigid Groves, a vice president at the American Pharmacists Association.”
    • Reuters tells us,
      • “The U.S. Food and Drug Administration said on Thursday it approved a ​treatment from Roivant (ROIV.O) and partner Priovant Therapeutics for a rare disease, ‌making it the first oral drug for the condition affecting skin and muscles.” * * *
      • “Branded as Lisraya, the drug was approved for ​dermatomyositis, a condition that causes painful skin rashes and progressive muscle weakness ​and, if untreated, can severely reduce quality of life.”
    • CNBC informs us,
      • “The Food and Drug Administration approved a once-daily HIV pill from Gilead that could help simplify care for some patients whose virus is already under control but who remain on complicated treatment regimens. 
      • “The tablet combines bictegravir, the backbone of Gilead’s blockbuster HIV pill Biktarvy, with lenacapavir, a centerpiece of the company’s long-term strategy for HIV treatment and prevention. 
      • “The new pill is also aimed at people who are doing well on a single-tablet regimen, including Biktarvy, and want to switch to a new treatment.”

    From the judicial front,

    • Michelle Roberts, an attorney, lets us know,
      • In Central States v. McClain [decided August 26, 2026, a panel of the U.S. Court of Appeals for the] Seventh Circuit held that ERISA does not preempt Arkansas Insurance Department Rule 128. Applying Rutledge, the court treated the Rule’s dispensing fee requirement as a permissible cost regulation rather than a mandate dictating plan choices, and under Gobeille, it held that the Rule’s reporting requirement fell within the exception for reporting incidental to an unpreempted state law. The panel affirmed dismissal at the pleading stage while expressly reserving whether Congress’s new pharmacy-compensation reporting provision under 29 U.S.C. § 1185o will change the analysis once it takes effect.
    • In National Infusion Centers v. Kennedy, also decided August 26, 2026, held
      • “The Plaintiffs challenge the constitutionality of the Drug Pricing Program created by the Inflation Reduction Act of 2022. They claim violations of the nondelegation doctrine, the Eighth Amendment’s Excessive Fines Clause, and the Fifth Amendment’s Due Process Clause. The district court granted the Government’s motion for summary judgment. We AFFIRM.”
    • Govexec reports,
      • “The Equal Employment Opportunity Commission voted 2-1 Wednesday to propose new regulations that would overhaul how federal workers may pursue workplace discrimination claims, removing employees’ right to request a hearing before an administrative judge and outright banning class action cases outside of federal court.
      • “Currently, federal workers alleging discrimination at their employing agency must undergo up to 90 days of pre-complaint counseling, which includes informing employees about the EEO process and sometimes mediation, after which their agency will conduct an internal investigation. Once that is complete—or after 180 days—the employee may request a hearing before an EEOC administrative judge.
      • “But under a new proposed rule, set for publication Friday in the Federal Register, complainants would no longer go through pre-complaint counseling, instead directly filing their complaints to EEOC within 60 days of the alleged discriminatory incident. And they would no longer be guaranteed a hearing; that decision would instead be made by officials within the EEOC’s Office of the Federal Sector.
      • “Under the plan, complainants would have to affirmatively request a hearing when they appeal a final agency decision, and in some cases submit an explanation justifying its need. Those who do receive a hearing under the new process would no longer have the benefit of discovery, a practice by which parties can request and receive documentation related to the case.
      • “Additionally, while employees with similar allegations of discrimination may elect to have their individual complaints processed “jointly,” EEOC would cease consideration of class action cases. If employees wish to proceed as a class, they would each have to exhaust their individual cases before the agency and then file a class action lawsuit in federal court.”

    From the public health and medical / Rx research front

    • The Wall Street Journal reports.
      • “[H]ow much water do we really need to drink a day? The question feels more pressing than ever given rising temperatures, heat waves and the fact that chugging water is almost a competitive sport these days. The answer may be less than you think and varies based on your size, health, activity level and where you live.” * * *
      • “The most cited recommendations for water come from the National Academy of Medicine, which calls for a total daily fluid intake of 3.7 liters for men and 2.7 liters for women. 
      • “But here’s the thing: That is total fluid intake, not water specifically. And here’s the other thing: Roughly 20% of our fluids come directly from food, studies have found.
      • “That leaves roughly two liters of fluids daily for women and three for men, says Kavouras. That translates to about 68 ounces and 101 ounces from beverages. 
      • “Stavros Kavouras, founding director of Arizona State University’s Hydration Science Lab in Phoenix and DrHydration on social media. estimates the average pour of water in the U.S. is 12 to 16 ounces. So that works out to about four to six glasses of fluids daily for women and six to eight for men.”
    • The New York Times relates,
      • “Scientists have uncovered a wealth of clues about how genetic mutations lead to severe forms of autism, offering opportunities for testing drugs that could treat the condition, according to a study published Thursday.
      • “The researchers charted how mutations change the way proteins work together in cells, altering the development of the brain.
      • “This is making maps of unknown territories that’s really necessary to move the biology forward,” said Dan Geschwind, a neurogeneticist at the University of California, Los Angeles, who was not involved in the study.
      • “Researchers have been studying autism for over 80 years, but it has only been in recent years that they have been able to explore its molecular biology. One reason that progress has been so slow is that autism is not just one condition, but a broad constellation of them.”
    • Radiology Business adds,
      • “A new analysis details the prevalence of amyloid-related imaging abnormalities (ARIA) on MRI in individuals who are being treated with new Alzheimer’s disease therapies. 
      • “Kisunla (donanemab) is an FDA-approved intravenous monoclonal antibody infusion for early symptomatic Alzheimer’s disease; it works by essentially scrubbing amyloid deposits from the brain, which in turn helps reduce cognitive symptoms associated with the neurodegenerative disease. While effective, a known side effect of the treatment is that is causes ARIA. 
      • “Symptoms of ARIA include headache, confusion, dizziness, vision changes and nausea, but if left unchecked, the symptoms can become severe. This is why experts (and the FDA) recommend scheduled MRI brain scans on individuals being treated with modern monoclonal antibody infusion treatments. 
      • “Now, a new study is offering detailed insight into how common ARIA is in individuals being treated with donanemab. Published in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitorin, the analysis suggests that up to 20% of patients may exhibit signs of ARIA on imaging.” 
    • MedPage Today tells us,
      • “Despite recommendations by the U.S. Preventive Services Task Force and the American Cancer Society, cervical cancer screening rates are declining.
      • “From 2005 to 2023, the proportion of women ages 21 to 29 never screened for cervical cancer increased from 12.5% to 31.9% (average annual percentage change [AAPC] 5.2%), with a notable increase from 2010 to 2023 (AAPC 7.9%).
      • “Regional-stage and distant-stage cervical cancer incidence has increased by 2.3% and 2.6%, respectively, per year among women ages 30 to 64 since 2017.”
    • and
      • “Almost 80% of patients with early-stage rectal cancer avoided surgery for a year or longer when treated with chemoradiation in a randomized trial.
      • “The organ-preservation strategies of chemoradiation and radiotherapy were both associated with few adverse events without sacrificing oncologic control.
      • “Longer follow-up is needed to determine long-term disease control and safety.”
    • and
      • “People who experience an opioid overdose are at greater risk of death, but data on which opioid agonist treatments are most effective in supporting this high-risk population are limited.
      • “In a retrospective cohort study of opioid overdose survivors, starting methadone was associated with a reduced risk of death during the subsequent year compared with starting buprenorphine-naloxone.
      • “In an accompanying commentary, experts questioned whether methadone is truly “intrinsically superior” to buprenorphine-naloxone.”

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

    • Beckers Payer Issues reports,
      • “Mona Chitre, PharmD, will serve as the market president for the newly created employer and government markets segment under Optum Rx, UnitedHealth Group’s pharmacy benefit manager.
      • “Dr. Chitre will begin her role Aug. 31, according to an Aug. 26 LinkedIn post. She said the role unifies the commercial, health system, coalition, labor and trust, and public sector businesses.
      • “Dr. Chitre most recently founded and was the president of Candesa Pharmacy Solutions, under The Lifetime Healthcare Companies. Under the same parent, she previously was Excellus BlueCross BlueShield’s chief pharmacy officer, according to her LinkedIn profile. She brings 26 years of experience across healthcare and pharmacy, she said.”
    • Fierce Healthcare relates,
      • “Cigna is looking to better link medical and supplemental benefits for its members, and has unveiled a new employer benefit that aims to further that goal.
      • “The insurer’s new Medical with Smart Coverage plans will be available as an option for employers with 500 to 2,999 employees that currently offer a high-deductible health plan. Cigna intends to expand access further in 2028, according to an announcement.
      • “The plan is designed to offer members support in managing unexpectedly high costs should they occur. Enrollees can access up to $7,000 in supplemental cash benefits that they can use during these health events to cover key needs such as transportation, child care or hotel stays.”
    • Beckers Hospital Review non-exhaustively lists “68 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
    • and tells us
      • New Haven, Conn.-based Yale New Haven Health System reported operating income of $33 million (0.5% operating margin) through the third quarter of 2026, up from an operating loss of $40.2 million (-0.7% margin) during the same period last year, according to its Aug. 25 financial report. 
    • and
      • “Pittsburgh-based UPMC recorded an operating loss of $18.3 million (-0.2% operating margin) for the second quarter of 2026, down from operating income of $111.2 million (1.3% margin) during the same period last year, according to its Aug. 27 financial report.”
    • Fierce Healthcare adds,
      • “Corewell Health showed its plans for two major hospital campus expansions that will run the Michigan nonprofit system $1.7 billion.
      •  “As our communities grow and patient needs become more complex, we are building the capacity, technology and care environments needed today for our patients and team members for many years to come,” President and CEO Tina Freese Decker said in the organization’s Thursday announcement. 
      • “The larger of the two projects is coming to Corewell Health Butterworth Hospital in Grand Rapids. The 780,000-square-foot, 11-story tower will include a new ED, 180 private patient rooms, 17 operating rooms and a hyperbaric chamber, Corewell said.” * * *
      • “The other new tower comes with a $440 price tag for the organization and will be built at Corewell Health Beaumont Troy Hospital, which serves a “rapidly growing” community and is also “consistently” above 90% capacity.”
    • and 
      • “Healthcare navigation platform Transcarent launched on Tuesday a bundled payment model for cancer therapies.
      • “The payment model, which the company touts as a first-of-its-kind, supports bispecific T-cell engager (BiTE) and CAR T therapies. Transcarent connects its members to leading oncology providers across various settings, including academic medical centers and high-quality community-based cancer care sites.
      • “Advanced cancer therapies are changing what’s possible for patients, but they’re also creating new challenges for employers trying to manage costs and access,” said Snezana Mahon, Transcarent’s president, in a statement. “This model gives employers more predictable costs while helping Members receive expert care closer to home without sacrificing quality.”
      • “The model enhances Transcarent’s Centers of Excellence (COE) program through easier access and navigation of more affordable care—offering potential savings of up to $150,000, executives say.
      • “Moreover, members undergoing treatment through the COE network are supported throughout their journey by certified oncology nurse navigators (ONNs).” 
    • Beckers Physician Leadership informs us,
      • “More than half of U.S. physicians, 59.4%, are now employed by a hospital or health system, according to a new analysis from Trilliant Health that assessed 700,000 physicians across the country.
      • “Here are four more things to know
        • “1. The hospital-employment rate is highest in the Midwest at 67.2% and lowest in the South at 52.4%, with the Northeast at 62.9% and the West at 60%. Multiple factors are driving the trend, with declining Medicare reimbursement chief among them. 
        • “2. The AMA estimates Medicare physician pay has declined 33% in real terms between 2001 and 2025 while practice costs rose 59% over the same period. 
        • “3. Among physicians who sold their practices to a hospital or health system, 79.5% cited the ability to negotiate higher payment rates as an important or very important reason for doing so. 
        • “4. Approximately 253,000 physicians became employees of hospitals or corporate entities between January 2018 and January 2026, with an additional 4,200 absorbed by insurers, private equity firms and pharmacy chains between 2024 and 2025.”

    Wednesday report

    David Ermer–FDA, Rx coverage, U.S. Healthcare, Uncategorized–

    Simplicity is a virtue.

    Quick Hits

    • Reuters adds,
      • “About 14% of employers in the United States have already or plan to drop GLP-1 drugs in 2027, as companies see ​rising healthcare costs, according to a survey released on Tuesday by the Business Group ‌on Health.
      • “Healthcare costs are set to increase 9.2% if employers do not make changes to manage costs in 2027, up from 8.5% in 2026, the group said. Two-thirds of employers surveyed said they saw rising utilization of ​the drugs.”
    • Healthcare Dive reports,
      • “The federal process for insurers and providers to settle disputes over out-of-network bills appears to be dramatically adding to U.S. healthcare spending, fueling calls for reform.
      • “That mechanism, set up by the No Surprises Act, has generated more than $22.4 billion in extra costs over just four years, according to new estimates from Georgetown University. That’s a significant acceleration from researcher’s past estimates of $5 billion in extra costs over the dispute resolution process’ first two years.
      • “But dispute volumes and total awards have continued to increase since — a worrying finding, given costs could push premiums up. The researchers urged policymakers to revisit the NSA.
    • The Wall Street Journal reports,
      • “For four decades, cancer researchers fought to disable a stubborn mutation that made pancreatic cancer a death sentence—to little avail. 
      • “Now, doctors have a medicine that targets the mutation. The Food and Drug Administration’s approval of the drug from Revolution Medicines on Wednesday marks a milestone in treatment of one of the most intractable kinds of tumors. 
      • “This is life-altering,” said Carla Kurkjian, an oncologist at Mercy Hospital in Oklahoma City, who wasn’t involved in the studies. “Not just for patients, as far as helping them extend their lives beyond anything we’d ever seen, but for us as physicians, to be able to have a different conversation than we’ve had for so long.”
      • “The drug, called Rasonque, helped subjects in a late-stage study live more than 13 months, nearly twice as long as those on chemotherapy alone. When presented at the world’s largest gathering of cancer researchers last spring, the results drew a nearly minute-long standing ovation.” 
      • “Yet the drug does have side effects, including a harsh rash across the body and gastrointestinal issues. Former Nebraska Sen. Ben Sasse, who went public in the spring with what he described as a significant reduction in his tumors while in a clinical trial of the drug, appeared on television with his face covered in red blotches.
      • “RevMed said the drug will cost $39,800 a month, or more than $477,000 a year.
      • “Wall Street expects Rasonque, which was approved for use in patients for whom other treatments failed, to be a big seller. The drug could generate more than $20 billion in annual sales, according to pharmaceutical commercial intelligence firm Evaluate, if the drug proves to work safely in earlier stages of the disease and with different types of cancers.”
    • The New York Times adds,
      • “The Food and Drug Administration’s approval on Wednesday of a new drug for pancreatic cancer marked the end of a long quest to develop a medicine that can hit one of cancer’s most elusive targets.
      • “Researchers hope the new drug is just the beginning, opening a new chapter in treatment for a range of cancer types.
      • “At least 79 drugs that take a similar approach are being tested in 238 clinical trials worldwide, according to one tally by academic researchers.
      • “Large drugmakers like Eli Lilly, Pfizer, Amgen and AstraZenecaare among the companies racing to develop their own medicines that work like the new drug, daraxonrasib, which is made by Revolution Medicines and will be sold as Rasonque.”
    • STAT News notes,
      • “The newer shingles vaccine has been turning heads since its link to lower dementia rates was reported two years ago. Now the same research team behind that observation has found an association between receiving the Shingrix shot and a reduced risk of heart disease.
      • “There have been signals before of cardiovascular benefits in people who got the newer, recombinant vaccine to prevent shingles, a painful, often serious flare-up in older people of the chickenpox virus from childhood. Those who got Shingrix were less likely than unvaccinated people to have heart attacks, strokes, or heart failure.” * * *
      • “Although the benefits are relatively small on an individual basis, millions of people receive shingles vaccination, meaning that even a small cardiovascular benefit could translate into a substantial number of cardiovascular events prevented at a population level,” Mark Russell, clinical senior lecturer and consultant rheumatologist of King’s College London, said in a statement shared by the Science Media Centre.” 

    Tuesday report

    David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, NIH, OPM, Patient safety, U.S. Healthcare–

    Simplicity is a virtue

    From Washington, DC

    • Beckers Hospital Review reports,
      • “CMS awarded Alaska $160 million through the Rural Health Transformation Program, funding 142 projects to expand access to rural healthcare statewide.
      • “The funding package includes $6.5 million to bring the first robotic-assisted minimally invasive surgery program to Southern Southeast Alaska, $5 million to build a tribally led residential treatment and recovery campus in Southeast Alaska, and more than $3.1 million to deploy AI-powered medical imaging across 21 acute care hospitals for faster stroke detection.
      • “Alaska will also use $250,000 to develop a drone-based pharmaceutical delivery system for villages spread across 94,000 square miles, where medication deliveries can take five to 14 days during winter months. Nearly $4.6 million will strengthen the Alaska Family Medicine Residency Program, and $4.75 million will expand health information exchange connectivity for rural providers.”
    • Beckers Payer Issues relates,
      • “Nine months after President Donald Trump announced a deal offering states discounted pricing on GLP-1 drugs for Medicaid patients, most states are declining to participate, according to an Aug. 22 Politico report.
      • “Only Indiana has publicly signed on, while 29 state Medicaid programs have said they will not participate and 14 more did not respond to requests for comment, according to the report. CMS also declined to provide a list of participating states.” * * *
      • “Medicaid spending on GLP-1s grew from $1 billion in 2019 to almost $9 billion in 2024, and nearly 40% of patients with obesity could qualify for coverage if states opted in, according to the report. States that do not cover the drugs can still direct Medicaid enrollees to purchase them out of pocket through TrumpRx. The platform lists injectable Wegovy and Ozempic at average prices of about $350 a month, down from more than $1,000, though some pricing comparisons have found many listed drugs are available for less through existing Medicare Part D or Medicaid discounts. Even at the discounted rates, the drugs may remain unaffordable for many low-income patients.”
    • Beckers ASC Review tells us,
      • “The Federal Trade Commission has finalized a consent order requiring Ascension Health Alliance to divest seven Amsurg ASCs across five markets as a condition of its $3.9 billion acquisition of Amsurg, which closed in early June, according to an Aug. 25 news release from the FTC.
      • “The seven centers span Nashville, Panama City, Fla., Tulsa, Okla., Waco, Texas and Wichita, Kan. Six will be divested to Optum’s SC Affiliates, while the Panama City center will go to Florida Gastroenterology Center. The FTC alleged the acquisition would limit competition for outpatient surgical services performed by gastroenterologists, ophthalmologists and orthopedists in those markets, potentially leading to higher prices and lower quality of care. 
      • “The final order also requires Ascension to provide prior notice to the FTC before acquiring any additional ASCs in the metro areas around the divested centers. The Commission voted 2-0 to approve the final order.
      • “The deal, which expanded Ascension’s ASC footprint from 58 to more than 300 centers across 34 states, gives the St. Louis-based health system one of the largest ASC networks in the country.” 
    • SHRM informs us,
      • “The U.S. Department of Labor (DOL) has finalized three rules dismantling or scaling back longstanding affirmative action requirements for federal contractors, completing a major piece of the White House’s effort to reshape federal equal employment opportunity enforcement.
      • “Published in the Federal Register Aug. 21, the rules address three pillars of the regulatory framework administered by DOL’s Office of Federal Contract Compliance Programs (OFCCP): Executive Order 11246, Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA).” * * *
      • “For contractors, the result is a substantially different compliance landscape — one with fewer federally mandated affirmative action metrics and data-collection requirements. However, there remain continuing obligations to prevent unlawful discrimination and, in the disability and protected-veteran contexts, enduring statutory affirmative action duties.”

    From the U.S. Office of Personnel Management front,

    • OPM published in today’s Federal Register the following final rule corrections:
      • Improving Performance, Accountability and Responsiveness in the Civil Service, and Recruitment and Relocation Incentive Waivers; Correcting Amendments FR Document:2026-17334 Citation: 91 FR 54796 PDF Pages 54796-54797 (2 pages) Permalink
      • Reduction in Force Appeals; Correction FR Document:2026-17338 Citation:91 FR 54796 PDF Page 54796 (1 page) Permalink
      • Reduction in Force; Correction FR Document:2026-17335 Citation:91 FR 54794 PDF Pages 54794-54796 (3 pages) Permalink
      • Streamlining Probationary and Trial Period Appeals; Correction and Technical Amendment FR Document:2026-17336 Citation: 91 FR 54793 PDF Pages 54793-54794 (2 pages) Permalink
      • Suitability Action Appeals; Correction. FR Document:2026-17337 Citation:91 FR 54798 PDF Page 54798 (1 page) Permalink
    • OPM Director Scott Kupor added another post to this Secrets of OPM blog (Substack link).
      • “This week, the Partnership for Public Service published an analysis claiming that agencies paid employees to leave through the Deferred Resignation Program (DRP) and then quietly hired their replacements. This is a claim that has surfaced frequently in the media in the past year: that the DRP reductions were not real because of backfills.
      • “The Partnership’s own analysis, however, confirms that these claims have no merit.
      • “According to OPM’s workforce data, 139,928 employees participated in the DRP. The Partnership identifies 20,557 subsequent hires that it considers “backfills.” Even accepting that figure at face value – the Partnership is using broad job classifications that can often encompass hundreds of actual jobs as a very imperfect proxy that likely significantly overstates actual backfills – it amounts to 14.7 percent of DRP participants.
      • Thus, more than 85 percent of employees who took the program are not matched to any subsequent hire. That’s pretty good for a program that was rolled out government-wide. Simply put, 85% of the reductions were real and lasting.”

    From the Food and Drug Administration front,

    • Reuters reports.
      • “The U.S. Department of Health and Human Services is planning to appoint two new deputy commissioners at the Food and Drug ​Administration, CNBC reported, citing sources familiar with the ‌matter.
      • “One role would focus on technology, including healthcare and AI, while the other would oversee drugs, according to two people familiar with the plans.”
    • Per Fierce Pharma,
      • “Jazz Pharmaceuticals’ bispecific antibody Ziihera has gained FDA approval for first-line HER2-positive stomach cancer, unlocking another market as the company builds toward a $2 billion-plus peak sales target. 
      • “The latest green light allows Ziihera to be used in addition to chemotherapy, with or without BeOne Medicines’ Tevimbra, in previously untreated, HER2-positive advanced gastroesophageal adenocarcinoma (GEA). 
      • ‘The approval permits Jazz to challenge more than a decade of practice, in which trastuzumab (Herceptin) has been the standard HER2 agent used alongside platinum-based chemotherapy—with or without a PD-1 inhibitor—as first-line therapy for these stomach cancer patients.” 
    • The Hill tells us.
      • “Vitruvias Therapeutics is voluntarily recalling one lot of thyroid tablets because they could potentially be “superpotent,” federal regulators announced this week.
      • “The high potency 30mg tablets could cause hyperthyroidism, or an overactive thyroid, according to the Food and Drug Administration. The affected lot (504950) was distributed nationwide to Vitruvias Therapeutics’ direct accounts from Jan. 31 to Sept. 30, 2025.”
    • Per an FDA news release,
      • “The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The Libre Duo 10 Day is the first wearable device in the U.S. that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar (glucose) together in a single device.
      • “Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency.”
      • “According to the Centers for Disease Control and Prevention, an estimated 40.1 million Americans are living with diabetes, a condition that requires careful monitoring of blood sugar levels. For the estimated 2.1 million Americans with type 1 diabetes, blood sugar is only part of the picture. When the body produces too much ketone, which is made by the body when it is using fat instead of glucose for energy, it can lead to diabetic ketoacidosis, or DKA — a serious complication that can develop quickly and become life-threatening if left untreated.”
    • Beckers Hospital Review points out,
      • “The FDA cleared Amygdala Neurosciences’ Investigational New Drug application for ANS-858, allowing the company to move the drug into clinical development.
      • “ANS-858 is a selective, reversible, orally bioavailable inhibitor of aldehyde dehydrogenase 2 (ALDH2), according to an Aug. 18 news release from the company. It plans to begin a phase 1 clinical trial, which is designed to support later evaluation of ANS-858 across multiple indications in phase 2 clinical trials.
      • “Amygdala Neurosciences is initially advancing ANS-858 as a potential treatment for alcohol use disorder and other substance use disorders. It is also evaluating the drug in compulsive eating disorders associated with binge eating and obesity.”
    •  Cardiovascular Business informs us,
      • “Young M. Lee, MD, a cerebrovascular surgeon with University Medical Center New Orleans, was the first U.S. physician to perform a stroke thrombectomy with Thunderbolt, a computer-assisted vacuum thrombectomy (CAVT) system from Penumbra that gained U.S. Food and Drug Administration (FDA) clearance back in June. 
      • “Lee performed the procedure on a young male patient who presented with a right middle cerebral artery (MCA) syndrome and a right M1 occlusion. He spoke to Cardiovascular Business about the experience, noting that this first patient was an especially challenging case due to preexisting intracranial atherosclerotic disease.
      • “I was able to observe the Thunderbolt essentially detect the clot and completely aspirate the clot starting from its proximal end in the mid-M1 segment all the way up to the point of the MCA bifurcation,” he explained. “With the fluoroscopy running, I could see the aspiration catheter advance towards the MCA bifurcation as the pump responded to what was happening, which is not something you see with a traditional non-modulated aspiration technique.”

    From the judicial front,

    • Federal News Network reports,
      • “The Trump administration is facing a new lawsuit from federal unions after it issued a pair of recent final rules overhauling federal employee suitability standards and performance evaluations.
      • “Filed on Monday in the U.S. District Court for the Northern District of California, the unions’ lawsuit contends that the Office of Personnel Management exceeded statutory authority and violated the intent of the Civil Service Reform Act when it issued regulations to change suitability and fitness regulations and reshape the performance management system for the federal workforce.
      • “Taken together, the changes will make it easier for OPM and agencies to fire federal employees, while limiting opportunity for employees to challenge their removals or other adverse actions, the unions argued. Their lawsuit is the latest of several legal challenges unions are taking against the Trump administration’s efforts to revise federal workforce policies and regulations.
      • “The American Federation of Government Employees is leading the lawsuit, with other plaintiffs including the National Federation of Federal Employees (NFFE), the International Federation of Professional and Technical Engineers (IFPTE) and the American Federation of State, County and Municipal Employees (AFSCME).”
    • Per a Justice Department news release,
      • “The Department of Justice today announced the emergency scheduling of three highly potent opioid compounds that pose an imminent hazard to public safety: mitragynine pseudoindoxyl, commonly known as MGPI, and two synthetic compounds known as MGM-15 and MGM-16.
      • “The Justice Department is acting before these dangerous compounds become a broader threat,” said Attorney General Todd Blanche. “These are potent opioids being manufactured and sold in consumer products, often under labels that obscure their true risks. This action will protect our nation’s children and communities from the dangers of drug addiction and abuse.”
      • “The Drug Enforcement Administration is temporarily placing the three 7-hydroxymitragynine-related substances in schedule I of the Controlled Substances Act. Preclinical evidence indicates that all three are potent mu-opioid receptor agonists and may present risks associated with other mu-opioid agonists, including dependence and respiratory depression. MGPI and MGM-15 are manufactured and marketed in products sold for their opioid effects. MGM-16 has not been confirmed in the consumer market but is a highly potent compound that could emerge as a substitute for related substances.”
    • The New York Times adds,
      • “Since the early 2000s, the number of fatal overdoses in the United States has soared. And the rate in Baltimore — 110 deaths per 100,000 residents, according to a recent analysis by the San Francisco Chronicle — is the highest among cities with a populations of a half-million or more.
      • “The initial cause was prescription opioids, then heroin, and then, starting a decade ago, a new generation of synthetic opioids, mainly fentanyl. Now, new combinations of ultrapotent lab-made drugs reach the street almost daily, making the narcotics supply — in Baltimore and beyond — more dangerous, polluted and unpredictable than it has ever been.” * * *
      • “Because lab-made drugs are so easily mixed and altered, their effect is uncertain; few buyers know what they’re actually getting, and the possibilities are expanding dangerously. Last summer, several mass overdoses in Baltimore resulted when fentanyl was mixed with N-methylclonazepam, a powerful sedative. Across the country, 22 percent of drug samples contained five or more compounds, an increase from 8.8 percent in 2022, according to testing done by the National Institutes for Science and Technology.”

    From the public health and medical / Rx research front,

    • The Wall Street Journal reports,
      • “Two unvaccinated people in Pennsylvania have died after contracting measles, the state health department said, the U.S.’s first measles-associated deaths reported this year.
      • “Both of the people lived in Lancaster County, a populous area in the southeast part of the state known for its large Amish community, the health department said Tuesday. The deaths mark Pennsylvania’s first measles-related fatalities in 35 years and are part of a larger outbreak in the state. 
      • “Pennsylvania has confirmed more than 390 cases of measles across 28 counties so far this year, all in people who weren’t fully vaccinated. Nearly half have come from Lancaster County. About a third of the Pennsylvanians affected are under 18 years old.
      • “I want to be clear: This illness and death from measles is completely preventable,” said Pennsylvania Gov. Josh Shapiro. “We already have the tools to protect ourselves and our families from this disease, which is one of the most contagious diseases on the face of the earth.”
    • The National Institutes of Health’s Research Matters covers the following topics in its latest issue.
      • “Dementia-free years may decrease with smoking, hypertension, and diabetes.
        • “Researchers found that smoking, high blood pressure, and diabetes in midlife lower the number of years a person is likely to live without dementia.
        • “The findings could help guide behavior and lifestyle changes to prevent dementia.
      • “Coating stops tooth decay in children.”
        • “A clinical trial found that a topical treatment called silver diamine fluoride stops cavities in young children from getting worse.
        • “The simple treatment could prevent surgery and other serious consequences for children with severe tooth decay.”
      • “DNA organization changes in Alzheimer’s disease, aging.”
        • “New research showed the 3D organization of DNA in cells changes in Alzheimer’s disease and aging.
        • “The results suggest the changes may contribute to altered gene activity observed in Alzheimer’s and aging.”
    • Health Day relates,
      • “A combo of hormone therapy and targeted drugs appears to help patients with metastatic breast cancer
      • “About 97% of patients benefited during the first six months
      • “The treatment, mainly using pills and under-the-skin injections, could eventually offer some patients an easier first-line option.”
    • and
      • “Hoping for a quick response from your doctor to a message sent through your patient portal?
      • “Then keep it cordial and positive, a new study suggests.
      • “Doctors were more likely to respond to messages that addressed them by name and had a positive tone, researchers reported Aug. 24 in JAMA Network Open.”
    • Beckers Hospital Review lets us know,
      • “Pediatric medications have more active FDA-listed shortages than any other therapeutic category, according to the FDA’s drug shortage database.
      • “Here are the categories with the most active shortage listings, ranked by number of active shortages as of Aug. 25:
        • 1. Pediatric: 18
        • 2. Anesthesia: 10 (tie)
        • 2. Cardiovascular: 10 (tie)
        • 3. Analgesia/addiction: 9 (tie)
        • 3. Gastroenterology: 9 (tie)
        • 4. Endocrinology/metabolism: 8 (tie)
        • 4. Neurology: 8 (tie)
        • 5. Anti-infective: 7 (tie)
        • 5. Oncology: 7 (tie)
        • 5. Psychiatry: 7 (tie)

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

    • Beckers Payer Issues reports,
      • “Most large health insurers posted stronger-than-expected earnings in the second quarter, but much of the improvement might not be durable, according to a Moody’s Ratings analysis published Aug. 24.
      • “Average EBITDA margins across the seven largest publicly traded insurers rose to 4.7% in Q2, up from 3.9% in the same period a year earlier. UnitedHealth Group posted the largest swing, expanding to 6.2% from 3.7%, while Centene jumped to 3.7% from 0.6% on the back of marketplace margin recovery and outperformance in its Medicare Advantage and prescription drug plan businesses. Five of the six insurers that reported results raised or affirmed full-year guidance.
      • “The rating agency cited high-cost specialty drugs, sustained behavioral health demand and aggressive provider billing and coding as ongoing pressures. The report also described a “clear industry pivot toward margin stabilization rather than top-line growth,” calling the shift broadly credit positive.”
    • Beckers ASC Review adds,
      • “For nearly as long as health insurers have used prior authorization to control costs, physicians and hospitals have argued it does more harm than good. 
      • “The pushback against prior authorization has reached new heights in recent months as healthcare leadership, legislators and physician advocacy organizations have proposed major reforms or outright bans of the practice.” 
    • Healthcare Dive relates,
      • “Name: Dr. Patrick Fox
      • “Previous title: President, Wellpoint New Jersey
      • “New title: President, Carelon Behavioral Health
      • “Fox is assuming the top role at Elevance’s behavioral health division effective immediately, the Indianapolis-based insurer announced Monday.”
    • Beckers Hospital Review tells us,
      • “New York City-based NewYork-Presbyterian reported operating income of $124.2 million (4% operating margin) during the second quarter of 2026, up from $101.7 million (3.6% margin) during the same period last year, according to its Aug. 24 disclosure report.”
    • and
      • “Orlando (Fla.) Health recorded operating income of $81.5 million (3.0% operating margin) in the third quarter of fiscal 2026, up from $56.3 million (2.2% margin) during the same period last year, according to its Aug. 25 finance report.”
    • and
      • “As health systems continue to grapple with financial pressures from rising labor and supply costs and reimbursement challenges, days cash on hand remains an important measure of financial stability. 
      • “[The article shares} days cash on hand figures for 25 health systems as of June 30, according to their most recent financial reports”
    • Fierce Healthcare tells us,
      • “The Oregon Health Authority (OHA) approved a deal on Monday that would merge the nonprofits MultiCare Health System and Samaritan Health Services.
      • “State regulators said the OHA’s Health Care Market Oversight (HCMO) program reviewed how the proposed merger would affect Samaritan’s facilities and its impact on Oregon citizens’ access to affordable and equitable healthcare. 
      • “HCMO approved the deal provided it meets established conditions (PDF), including requiring MultiCare to follow its financial commitment of investing $700 million towards Samaritan and posting a public-facing version of the commitment on Samaritan’s website. Other conditions involve reinvestment of Samaritan’s operating margins into local communities and a requirement to maintain existing services.”
    • and
      • “Artificial intelligence-driven specialty care navigation platform Switchboard Health announced Tuesday the acquisition of virtual orthopedics and musculoskeletal (MSK) management provider Livara Health.
      • “Switchboard Health will embed Livara’s MSK program in its automation platform for referral management and care navigation, through the acquisition, to enable providers and health plans to enroll patients.
      • “Financial details of the transaction were not disclosed.”
    • Beckers Physician Leadership informs us,
      • More than half of active U.S. physicians worked for hospital systems as of 2024, up from 20% in 2010, and hospital systems have acquired more than 20,000 physician practices since 2015, according to a recent study published in JAMA Network Open.
      • Becker’s ASC Review tracked more than 50 physician practice deals in 2026 — with consolidation taking over some areas of medicine more than others. 
      • [The article provides] a breakdown by across five specialties.

    Notable Death

    • The Wall Street Journal reports,
      • “One night in 1973, Dolly Parton had a song on her mind. She was thinking about a bank teller who had been flirting with her spouse.
      • “She got this terrible crush on my husband,” Parton told NPR in 2008. “And he just loved going to the bank because she paid him so much attention.”
      • “Needing a name for this tall, redheaded temptress, she thought of another flame-haired girl, an 8-year-old who approached her for an autograph after a taping of “The Porter Wagoner Show,” the TV series on which she was featured. That child’s name was Jolene.
      • “Parton died Tuesday at age 80 in Nashville, Tenn., according to her family. The cause of death wasn’t released. In May, Parton canceled a Las Vegas residency because of health issues.”
    • Beckers Hospital Review adds,
      • “Beyond her music and film career, Ms. Parton spent decades directing philanthropic dollars toward hospitals and medical research, much of it concentrated in her native East Tennessee and at Nashville-based Vanderbilt Health. [The article shares] seven ways her giving left an imprint on healthcare.

    Monday report

    David Ermer–Agentic & Generative AI, CMS, Federal employment benefits, Medicare, OPM, Rx coverage, Telehealth, U.S. Healthcare–

    Simplicity is a virtue.

    From Washington, DC

    • Per Centers for Medicare and Medicaid Services news release,
      • “The Trump Administration announced today that a $144 million investment is being delivered to improve health outcomes for Alabamians through the federal Rural Health Transformation Program (RHTP) This investment will support 138 grants to expand access to care, modernize healthcare technology and infrastructure and strengthen the rural healthcare workforce.
      • “This funding will help rural providers modernize their technology and cybersecurity, enhance telehealth and mobile care services, strengthen emergency and maternal care, and improve access to mental health and substance use care. The Trump Administration is also investing in expanding the healthcare workforce through training, scholarships, apprenticeships, and recruitment efforts, while helping local providers strengthen community-based care and better coordinate services. These investments will help make healthcare more accessible, connected, secure and sustainable across Alabama regardless of your zip code.”
    • Per a Department of Health and Human Services news release,
      • “U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. and Secretary of Agriculture Brooke L. Rollins today announced sweeping new efforts to strengthen school meals by connecting more American farmers with local schools, investing in school kitchen infrastructure, and giving states and school districts new tools to serve healthier, more nutrient-dense meals to America’s children.
      • “Secretary Kennedy joined Secretary Rollins at the U.S. Department of Agriculture (USDA) alongside farmers, students, school nutrition leaders, athletes, chefs, and parents to announce the next phase of the Trump Administration’s work to Make America Healthy Again.” * * *
      • “If we want to Make America Healthy Again, we have to start with our children, and that means improving what we put on their lunch trays every single day,” said Secretary Brooke L. Rollins. “Harvest to Hallways is about bringing more American agriculture into the school cafeteria. We are connecting schools with the farmers and ranchers in their own communities, investing in the kitchens and equipment school nutrition professionals need to prepare real food, and cutting through barriers that have made it too difficult to serve healthy, American-grown food. When we strengthen the connection between the farm and the lunchroom, everybody wins: our children eat better, our farmers gain new markets, and our communities grow stronger.”
    • STAT News adds,
      • “New restrictions on the use of food benefits to purchase soda and candy have been one of the biggest changes enacted by the Make America Healthy Again movement. But a key question has been how profoundly the bans would affect public health, with some economists arguing that people would just use other funds to buy Coke and other sugary drinks instead.
      • “Now a new study shows that soda purchases did indeed fall by about 12% among people who receive Supplemental Nutritional Assistance Program benefits after the bans went into effect in 10 states. The study, which was published by the National Bureau of Economic Research and has not yet been peer-reviewed, says this translates to a person drinking about 34 fewer 12-ounce cans of soda per year.”
      • “That’s not huge, according to the study’s authors, but it’s far from nothing.”
    • Beckers Hospital Review reports,
      • “More than 200 healthcare organizations urged CMS not to finalize proposed limits on remote monitoring, warning the changes would disrupt care for about 1 million Medicare beneficiaries who manage chronic conditions from home.
      • “In a sign-on letter to CMS Administrator Mehmet Oz, MD, the coalition asked the agency to hold off on remote physiologic monitoring and remote therapeutic monitoring policies included in the 2027 Medicare Physician Fee Schedule proposed rule. More than 30 health systems and hospitals signed the letter. 
      • “The provision at issue, proposed July 14, would allow clinical practices to bill Medicare for the services only if the clinical staff delivering them are directly employed by the billing practice rather than contracted through a third-party vendor. Staff could still work off-site; the billing relationship would have to run in-house.
      • “That distinction carries broad reach. An estimated 60% to 70% of hospitals and health systems using remote monitoring rely on partially or fully outsourced vendor models, according to Becker’sprior reporting. The signers of the letter said small practices, rural providers and safety-net organizations would be hit hardest, and that many would have no option but to cut enrollment or end their programs.”

    From the U.S. Office of Personnel Management front

    • FedWeek reports,
      • “President Trump has not yet sent Congress the alternative pay plan letter that will determine the 2027 federal pay raise, and the statutory deadline to do so arrives August 31. The letter is the clearest remaining signal of whether federal employees face a full pay freeze next year or another modest increase similar to the one delivered a year ago.
      • “Under the Federal Employees Pay Comparability Act (FEPCA) of 1990, the president must submit an alternative pay plan to Congress by the end of August, or a statutory formula tied to private-sector wage growth automatically takes effect instead, producing a far larger locality pay increase than any administration has allowed to take hold since the law passed. FedSmith has explained the mechanics of this deadline before, and last year’s letter covering the 2026 raise arrived on August 28, just three days before the cutoff. A similarly late announcement is likely again this year.”
    • and
      • Federal employees under the General Schedule receive a base salary plus a locality payment that varies by geographic area. The 2026 rates range from 17.06% in the Rest of U.S. locality pay area to 46.34% in the San Jose-San Francisco-Oakland, CA, locality pay area.
      • “The federal locality pay system adjusts General Schedule salaries to reflect differences in non-federal pay levels across geographic regions. Authorized by the Federal Employees Pay Comparability Act of 1990, the system took effect in January 1994. Its purpose is to reduce pay disparities between federal and non-federal workers performing similar work in the same labor market.
      • “Locality payments are calculated as a percentage of base pay and applied according to the employee’s official worksite. The Office of Personnel Management publishes annual tables that incorporate both the across-the-board base pay increase and the locality adjustment for each designated area. For 2026, locality pay percentages remain at the prior year’s levels, while base pay received a 1.0% across-the-board increase.”

    From the Food and Drug Administration front,

    • The Wall Street Journal reports,
      • “The Food and Drug Administration cleared a blood test for identifying Alzheimer’s disease symptoms, which was developed by Roche and Eli Lilly.
      • “The Elecsys Phospho-Tau Plasma test identifies amyloid pathology associated with Alzheimer’s in people 55 years or older.
      • “It provides positive, intermediate and negative result categories to support doctors assessing the likelihood of amyloid pathology. Results are interpreted in conjunction with clinical information and other relevant findings as part of an Alzheimer’s diagnosis.
      • “The blood test is meant to address the gap in diagnoses, as an estimated 75% of people living with dementia are undiagnosed, Roche said.
      • “Quest Diagnostics and Labcorp both said they plan to start offering the blood test.”
    • MedTech Dive relates,
      • “The Food and Drug Administration has picked two behavioral health companies to join its Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, growing the total number of participants to four.
      • “Limbic and Sondermind are the next companies to join the pilot program, which allows participants to gather real-world data on devices while being exempted from premarket authorization requirements.
      • “Amid the pilot program, the FDA has also held discussions on digital health technologies for mental health, with patient groups calling for broader oversight in the use of generative artificial intelligence.”
    • Beckers Hospital Review tells us,
      • “The FDA has again paused Regenxbios RGX-121 gene therapy trial for Hunter syndrome after small, asymptomatic masses were found on the spines of five patients. Regenxbio does not expect to resubmit its biologics license application for the therapy in the near term.
      • “The spine findings, either a small nodule or cystic mass, surfaced through an expanded MRI monitoring plan Regenxbio adopted a few months ago, according to an Aug. 24 news release. All five patients received intracisternal or intraventricular RGX-121 three to six years ago, remain asymptomatic and have shown stability to improvement on neurocognitive assessments. Investigators consider the findings nonserious and likely benign, though no pathological evidence confirms their cause.
      • “The pause comes seven months after Regenxbio disclosed that a boy who received its similar MPS I therapy, RGX-111, developed a brain tumor, a case researchers have since linked to AAV gene therapy, the vector platform used in most gene therapies over the past 20 years.”

    From the judicial front,

    • Fierce Pharma reports,
      • “On Monday, the U.S. District Court for the District of Columbia ruled against Merck & Co., rejecting its claim that the price negotiations are unconstitutional because they violate the First and Fifth Amendments. The argument is one that has been made by multiple drugmakers pushing back against the program.” 
    • Per a Justice Department news release,
      • “Today, the U.S. Department of Justice announced the launch of the National Fraud Detection Center (NFDC), a prosecutor-led, multi-agency team designed to investigate the most harmful actors defrauding federal government programs, including illicit actors overseas and those operating fraud schemes across federal programs. The NFDC will bring together law enforcement agencies and analytical capabilities to generate criminal leads to drive more impactful prosecutions and enhance fraud-fighting results for the American people.
      • “The creation of the NFDC marks a decisive shift in how the federal government detects and investigates complex fraud,” said Assistant Attorney General Colin McDonald of the Justice Department’s National Fraud Enforcement Division. “By breaking down institutional silos, embedding analysts from across the IG community, and leveraging shared technology, the NFDC is actively closing the window of opportunity for bad actors who seek to exploit taxpayer dollars. Today’s announcement sends a clear message: if you defraud federal programs, we have the tools and the law enforcement partners to find you.”

    From the public health and medical / Rx research front,

    • Beckers Hospital Review reports,
      • “A fast-moving wildfire in the Sierra Nevada foothills has forced two Northern Nevada Health System facilities in the Reno, Nev., area to evacuate patients and close, according to CBS News and The New York Times.
      • “Both facilities remain closed with no timeline to reopen. The health system said it is in active communication with emergency response teams and will reopen each facility once crews clear the area and deem it safe, at which point it will activate an opening plan and notify the community.”
    • Better Report tells us.
      • “We spoke with board-certified emergency medicine physician Dr. Joseph Radachy about what he wishes more patients would prioritize. From simple ways to avoid everyday accidents to daily practices that support long-term health, here are six things your doctor wishes you’d do.
        • Stay Active Physically and Medically
        • Make your House Safer.
        • Advocate for Yourself
        • Know your Medical History
        • Remember: Moderation in Everything
        • Stop Smoking
    • The New York Time asked experts whether the bland BRAT diet is the best way to treat a stomach bug.
    • The American Medical Association lets us know “what doctors want patients to know about dry eyes.
      • “Dry eye disease can cause burning, tearing and blurry vision. Learn what triggers symptoms, which treatments help and when to seek care.”
    • Beckers Behavioral Health informs us,
      • “The age-adjusted death rate for alcohol-induced deaths among U.S. adults aged 45 and older increased from 2014 to 2024, according to an Aug. 20 report from the CDC’s National Center for Health Statistics.
      • “Death rates increased from 19.5 per 100,000 population in 2014 to 25.2 in 2024. In 2024, the death rate was 36.8 among men and 14.3 among women. Death rates were higher among men than women throughout the 2014–2024 period.
      • “The findings are based on National Vital Statistics System mortality data.
    • Parkinson’s News Today points out,
      • “Parkinson’s disease involves the progressive loss of dopamine-producing neurons, leading to motor symptoms.
      • “Starting rehabilitation within the first year of a Parkinson’s diagnosis may be linked to longer survival.
      • “Delaying rehabilitation is associated with a progressively higher risk of mortality across all disability levels.”
    • Genetic Engineering and Biotechnology New notes,
      • “Cancer metastasis is responsible for at least two-thirds of cancer deaths. Drugs targeting the metastatic progression have largely failed, in part due to the lack of predictive models that would help identify the underlying mechanisms of metastasis.
      • “Now, new work reports the development of a multi-organ chip that mimics how cancer cells spread from vascular flow to distant organs—the first model of cancer metastasis of its kind. The chip includes compartments with millimeter-sized engineered human bone and lung tissues, and the vascular flow that contains circulating breast cancer cells and allows the dynamic cross-talk of the tissues being colonized.
      • “The key advantages of this advanced model of metastasis are that it is human and can be patient-specific,” said Gordana Vunjak-Novakovic, PhD, university professor and professor of biomedical engineering and professor of medical sciences at Columbia University. “It faithfully mimics some of the key aspects of human metastasis that are otherwise largely inaccessible for direct study.”
      • “This work is published in Science Translational Medicine in the paper, “Organ-specific colonization and niche remodeling in a human tissue model of metastasis.”
    • STAT News takes us “inside Moderna and Merck’s cancer vaccine triumph.
      • “The drugmakers overcame rampant doubts, logistical challenges, and the pandemic.”

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

    • Fierce Healthcare reports,
      • “Highmark Health closed the first half of the year with $17.5 billion in revenue and $2 billion in net income, bolstered by a significant turnaround at its insurance unit.
      • “The $2 billion in net income accounts for $911 million in non-cash gains from the company’s affiliations with Blue Cross and Blue Shield of Kansas City and Heritage Valley Health System.
      • “Highmark Health Plans posted $672 million in operating income through the first two quarters of 2026, an increase of $612 million compared to the first half of 2025. Highmark said in the announcement that it expects elevated utilization and cost trends to persist across the industry, though pressures have eased.”
    • and
      • “Berry Street, a nutrition care company, has merged with India-based Healthify to form what executives call the largest insurance-covered AI metabolic health platform in the U.S. 
      • “The merger combines Healthify’s AI technology, including its nutrition and metabolic health assistant Ria, with Berry Street’s nationwide network of more than 2,000 clinicians and insurance-covered nutrition and GLP-1 care. The companies say the goal is to offer AI-powered, clinician-backed metabolic health support accessible through health insurance.
      • “Financial details of the merger were not disclosed. Berry Street shared the news exclusively with Fierce Healthcare.”
    • Beckers ASC Review relates,
      • “Kaiser Permanente is advancing construction plans for its long-planned Redlands, Calif., medical campus, with the Redlands Planning Commission set to review detailed site plans for the project’s first building Aug. 25, Community Forward Redlands reported  Aug. 24.
      • “The commission will consider a 113,000-square-foot, three-story medical office and ASC at Kaiser’s existing property. The building, known as Medical Office Building/Ambulatory Surgery Center 2, would house urgent care, outpatient surgery, chemotherapy infusion, imaging, laboratory services and medical offices.”
    • and
      • “Becker’s has reported on more than 30 ASC closures in 2026 as outpatient surgery facilities cite consolidation, efficiency and shifting care sites. 
      • “[The article offers] a look inside five more recent ASC closures as the industry battles reimbursement declines, staffing shortages and shifting market power dynamics. 
    • Healthcare IT News tells us,
      • “Telemedicine has made it routine for clinicians and patients to connect by video. But for health systems, establishing that connection is no longer the hardest part of virtual care. The bigger challenge is making sure the right patient gets a virtual visit in the first place – and that everything that should happen afterward actually happens.
      • “For telehealth veteran Dr. Joe Kvedar, professor of dermatology at Harvard Medical School and senior clinical advisor and two-time board chair at the American Telemedicine Association, the operational issues confronting provider organizations now come down largely to two areas: EHR integration and patient triage.
      • “Many health systems have made substantial progress integrating telemedicine into the electronic health record, says Kvedar, but determining which patients and conditions truly belong in a virtual encounter remains more difficult.”
    • and
      • “For decades, hospitals have largely treated discharge as the end of the acute care journey. Once patients left the building with a folder of instructions and follow-up recommendations, responsibility shifted largely to them and their families.
      • “But that approach is becoming increasingly difficult to sustain as hospitals assume greater accountability for patient outcomes long after patients leave inpatient care.
      • “New payment models, continued pressure to reduce avoidable readmissions and growing expectations for coordinated care are forcing provider organizations to rethink what happens after discharge.
      • “For Dimer Health CEO Caroline Hodge, PA-C, the answer is straightforward: Transitional care must become an active, technology-enabled extension of the hospital, rather than a passive handoff.
      • “The first 90 days aren’t an afterthought anymore,” Hodge said. “They’re where the outcome, and the economics, actually get decided.”
    • MedTech Dive informs us,
      • “MiniMed has begun shipping its new insulin pump in the U.S. with the Abbott-made Instinct sensor, the Medtronic spinout said last week. The sensor can be used for up to 15 days before it needs to be changed.
      • “The company said the rollout of its new MiniMed Flex delivery device with Instinct combines the smallest and only app-controlled insulin pump with the world’s smallest sensor.
      • “MiniMed is supporting the launch with its first major marketing campaign for the insulin pump. The campaign focuses on MiniMed Flex’s “discreet” design, app control and automation.”
    • Beckers Hospital Review notes,
      • “Mark Cuban Cost Plus Drug Co. has partnered with RxSaveCard and nonprofit Golden Thread to streamline sourcing and reduce costs of pediatric cancer clinical trial medications. 
      • “Once enrolled in a study, patients will sign up for RxSaveCard and receive trial medications delivered to their homes through Cost Plus Drugs, according to a news release shared with Becker’s.
      • “No study should stall over the price of a generic drug and no family should wait on one,” Alan Bowe, chief commercial officer at Cost Plus Drugs, said in the release. “We’re proud to work with Golden Thread and RxSaveCard to make trial medications affordable and deliver them directly to patients’ doors and we hope every trial that needs this model uses it.”

    Weekend update

    David Ermer–Congress, COVID-19, FDA, Obesity, U.S. Healthcare–

    Simplicity is a virtue.

    From Washington, DC,

    • This is the last week that both Houses of Congress are out of town on State/District work period. The House of Representatives returns to Capitol Hill on August 31 and the Senate returns on September 14. Both Houses head out on the campaign trail on October 1 until the week following the national election day on November 2.
    • Global BioDefense reports,
      • “The federal government wants to lock in vaccine manufacturers now, well before the next flu pandemic arrives, rather than scramble to build production capacity after one begins. The Biomedical Advanced Research and Development Authority (BARDA) released a request for proposals on August 17 seeking companies to maintain what the agency calls warm base manufacturing capacity for pandemic influenza vaccines, a standing readiness posture that keeps production lines, seed stocks, and regulatory groundwork in place so doses can start flowing quickly once a pandemic strain emerges.”

    From the Food and Drug Administration front,

    • MedTech Dive reports,
      • “After receiving Europe’s CE mark earlier this year, Abbott is preparing to bring a dual glucose-ketone sensor to the U.S.
      • “The company has filed an application for its new device, called Libre Duo, with the Food and Drug Administration, with expectations for approval before the end of the year.
      • “Abbott hopes that by allowing people to be more aware of ketone levels, the new device will help prevent diabetic ketoacidosis, or DKA, a serious complication of diabetes where the body lacks insulin. However, broader access to ketone measurement also brings questions around best practices for interpreting and acting on this new data.”
      • MedTech Dive interviews endrinologists about this development in the article. 

    From the public health and medical / Rx research front

    • Tech Times lets us know where with stand with the summer Covid surge and what it means for the fall season.
    • Medscape relates,
      • “Adults on GLP-1s who lost weight during their first year on the medications are likely to maintain that loss through the second year of use, according to two new Cosmos studies.
      • “That finding was true for those with diabetes and without.
      • “We did observe that patients without diabetes had higher rates of maintaining that weight loss,” said Kersten Bartelt, RN, a researcher at Epic Research and a coauthor on both studies. And those on tirzepatide had lower rates of weight regain that those on semaglutide, the two medications studied.
      • “Bottom line? Continued use of GLP-1s means continued weight loss benefit or maintenance, Bartelt said.”
    • STAT News tells us,
      • “If you could design an oral treatment that limits appetite and mimics some effects of physical activity, you might call it exercise in a pill. Now a company is releasing early results for a compound to do just that.
      • “The pill, the company hopes, can maintain weight loss without the common gastrointestinal effects of GLP-1s. The component of exercise it is designed to re-create is preservation of lean muscle mass, a concern when people yo-yo on and off GLP-1 drugs, losing more muscle each time.
      • “Those researchers showed in a 2022 Nature paper that lac-phe can suppress appetite and lower obesity in animals. Lac-phe and ENV-308, Enveda’s chemically engineered version, both act on leptin, a hormone that has been the target of scientists and drug developers for decades. If confirmed in clinical trials, the company says, ENV-308 would be the first “leptin sensitizer in a pill.” 
      • “ENV308 is our attempt to put the chemistry of exercise into a daily tablet,” said Viswa Colluru, Enveda’s founder and CEO.”

    From the U.S. healthcare business front,

    • Kaufmann Hall released its 2nd Quarter 2026 Physicians’ Flash Report last week.
      • The investment curve for providers has flattened. The investment/subsidy per both provider and physician has remained steady year-over-year, a positive sign for medical group performance.
      • Advanced practice providers (APPs) are helping control costs. The number of APPs continues to steadily increase, now making up 41.2% of the Total Provider FTEs represented in this sample. As medical groups continue to design strategic APP and physician staffing models, organizations may continue to see stronger returns in overall team effectiveness, productivity, and cost control.
      • Continued increases in productivity are offsetting expense growth but stretching providers. Physician and provider (APPs or otherwise) work relative value units (wRVUs) per FTE grew 3% and 2%, respectively, showing continued increases in productivity. While this may drive revenue to help offset expense growth, it can also increase burnout and impact quality of care.
      • Support staff levels continue to tighten, leaving providers to absorb more work. Support staff expense fell slightly, reflecting ongoing hiring and retention challenges. As staffing tightens, physicians and APPs may need to take on more non-clinical tasks, presenting challenges in working at the top of their license.
    • An AHIP news release adds,
      • “Each year brand drugmakers make tens of millions of dollars in payments to physicians— consulting fees, speaking honoraria, meals, travel and more. A new analysis of disclosures from 10 of the largest brand drugmakers, contained within the Centers for Medicare & Medicaid Services (CMS) Open Payments data, reveals these manufacturers spent nearly $200 million on payments to more than half a million physicians in 2024 alone.
      • “CMS data shows that physicians receiving payments from these 10 brand manufacturers then billed fee-for-service Medicare nearly $45 billion for drugs made by those same manufacturers in 2024. The return on investment for those manufacturers was a staggering $220 in sales for every dollar in physician payments. 
      • “This analysis builds on mounting evidence that physicians who receive manufacturer payments prescribe more drugs sold by those manufacturers.”