Happy Labor Day

Mental health care

Happy Labor Day

David Ermer–Congress, Mental health care, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The House of Representatives and the Senate will be on District/State work breaks this week following Labor Day.

From the public health and medical / Rx research front

  • The New York Times reports,
    • “Medications are like barnacles,” said Dr. Michael Steinman, a geriatrician at the University of California, San Francisco, and co-director of the U.S. Deprescribing Research Network. “They’re easy to start, but they can be hard to stop.” * * *
    • “Recent studies of three medications or classes of drugs widely used among older Americans illustrate the problem.
      • The Drawbacks of Benzodiazepines
      • Overprescribing Antibiotics
      • When Aspirin isn’t the Answer.
  • Health Day relates,
    • “Heart-pumping aerobic exercise can boost key thinking skills among women after menopause, a new study says.
    • “Postmenopausal women who practiced aerobic exercise four days a week for half a year performed better on cognitive tests than those who focused on stretching and toning, researchers reported recently in the Journal of Alzheimer’s Disease.
    • “Women who did aerobics specifically improved in their executive function — the brain skills that help people plan, juggle tasks, stay focused and maintain independence, results showed.”
  • Beckers Behavioral Health tells us,
    • “Suicide-related emergency department visits among children increased 74% from 2016 to 2022, according to a study published Sept. 3 in Annals of Emergency Medicine. The study represented more than 5 million pediatric mental health ED visits in the U.S.”

From the U.S. healthcare business front,

  • Avalere Health points out,
    • “Publicly traded health plans recently reported their second quarter financial performance. To assess reported trends, Avalere Health analyzed 10Q forms and filings and earnings call transcripts from six publicly traded health plans: Centene, Cigna, CVS Health, Elevance Health, Humana, and UnitedHealth. Overall, we found that while margins have increased year-over-year, elevated medical costs continue to pressure plans, forcing plans to reexamine membership profitability and reevaluate growth strategies.”
  • The Wall Street Journal reports,
    • “About 92% of U.S. health providers now encourage or require prepayment or collect a payment method on file during the medical estimate process.
    • “The trend is driven by insurers shifting more costs to patients, leaving hospitals struggling to collect unpaid bills after procedures.
    • “While federal law doesn’t bar prepayment requests for nonemergency services, some states are enacting laws to address aspects of the trend.”
  • and
    • “China is emerging as a favored destination for overseas cancer patients seeking CAR-T therapy due to lower costs and biotech innovation.
    • “CAR-T therapy in China can range from $150,000 to $230,000, compared with $550,000 to $850,000 in the U.S.
    • “Chinese regulators have approved nine CAR-T products, the most in the world, including the first approved CAR-T therapy for solid tumors.”
  • Beckers Hospital Review offers “A tale of 2 retailers: What drives success for co-branded Medicare Advantage plans.”

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.”

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.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Mental health care, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Hill reports,
    • “Lawmakers are sounding the alarm over the nation’s $40 trillion debt, lamenting Congress’s inability to meaningfully confront a problem that has grown increasingly difficult to ignore.
    • “Both parties have spent years trying to tackle the rising debt. Republicans have frequently pointed to federal spending and entitlement programs as the main drivers, while Democrats have emphasized the need for higher taxes on wealthy Americans and corporations alongside spending reforms.
    • “But efforts to reach a broader deal have repeatedly stalled as both parties have balked at the politically painful trade-offs needed to put the nation on a more sustainable fiscal path.” 
  • Modern Healthcare relates,
    • “A Senate bill [S. 3097 – Health Information Privacy Reform Act] would create medical privacy protections for consumer health products such as wearables and wellness apps.
    • “The legislation unanimously passed the Senate health committee last month and a similar bill is pending in the House.
    • “Stronger privacy rules could hamper some tech companies while benefiting others as well as providers eager to tap into new technology.”
  • Per a CMS news release,
    • “The Trump Administration announced an additional $4.2 million, made possible through the federal Rural Health Transformation Program (RHTP), is being put to work in West Virginia to expand patients’ transportation options and remove service barriers.
    • “By injecting millions into the Rural Health Link initiative, the Administration is upending the status quo that has limited transportation options for residents in need of critical healthcare services and delivering on its commitment to West Virginians who deserve the best access to care no matter their zip code. These funds will help increase medical transportation capacity, service availability, and improve geographic coverage for patients across the Mountain State.” 

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

  • Today’s Washington Post included an oped written by OPM Director Scott Kupor about his agency’s efforts to improve the merit system.
    • “At the Office of Personnel Management — Washington’s chief HR agency — my team has spent the past 20 months reforming this system. Our goal is simple and uncontroversial: Merit matters, not how long employees have been in a role or what college degree they earned, both in hiring and in day-to-day performance. That means accountability for employees who can’t deliver and distinction for those who knock the cover off the ball.”
  • Govexec adds,
    • “An agency spokeswoman said that a four-person communications team — all under the age of 30 — is spearheading the effort to make OPM’s social media more appealing to younger potential hires.”
  • Tammy Flanagan writing in Govexec, lets us know,
    • “Retiring from federal service is a major milestone, of course, but it does not end the need to understand how federal benefits work. In the years after retirement, life events and new opportunities can raise important questions about insurance, survivor benefits, beneficiary designations and the effect of returning to government employment.
    • “Today I will highlight several post-retirement issues that federal employees may want to plan for in advance. This is not an all-inclusive list, but it’s a list that will hopefully remind you that it is important to review your benefits and be sure to understand how they can change as life goes on.” * * *
    • “Health benefits can also change after retirement, not only the premiums and the benefits, but your needs may change over time. Outside of open season, FEHB changes generally must be tied to a Qualifying Life Event (QLE), such as marriage, divorce, death of a family member, or a move out of a plan’s service area, and many changes must be requested within 60 days of the event.
    • “Annuitants should confirm the effective date with OPM because the timing can depend on the type of change. For example, some enrollment decreases may be made at any time and are commonly effective at the beginning of the month after OPM receives the election, while other changes follow the qualifying life event rules.
    • “There is a little-known option to change insurance just because you have reached age 65, it is QLE 2L. This is your “ace in the hole” that you can only use once in your lifetime to change plans outside of open season.
    • “This is generally used to change plans when enrolling in Medicare after retirement, but if not used at age 65, it can be used later – but only once!”

From the Food and Drug Administration front,

  • CBS News reports,
    • “A New York-based consumer healthcare company is recalling nearly 40,000 bottles of eye drops over concerns about the product’s sterility. 
    • “Prestige Consumer Healthcare initiated the recall on July 29 due to “lack of assurance of sterility,” according to a U.S. Food and Drug Administration notice.
    • “The recall is due to potential contamination,” the notice says.
    • “The recall affects 15mL bottles of Clear Eyes’ Maximum Itchy Eye Relief, which mitigates itchiness, redness and other eye irritations, according to the product description. The eye drops were distributed nationwide.”
  • Fierce Pharma relates,
    • “If at first you don’t succeed in gene therapy, then try, try again. That’s the lesson Ultragenyx likely took home this week as it pocketed its first FDA nod in the class just over a year after a separate program stalled on manufacturing grounds. 
    • “Late Wednesday, the FDA gave an accelerated go-ahead to pariglasgene brecaparvovec-opnr, Ultragenyx’s AAV gene therapy for the rare genetic disorder glycogen storage disease type Ia (GSDIa), which will now head to market with the brand name Genglycos. 
    • “The accelerated approval specifically covers the gene therapy—previously coded as DTX401—in adults and kids over the age of 8 years with GSDIa, an ultrarare genetic disorder driven by a deficiency of the enzyme G6PC, which is needed to release glucose from the liver into the bloodstream. The liver is less capable of controlling glucose levels in these patients, leading to potentially life-threatening hypoglycemia episodes and other complications. 
    • “By Ultragenyx’s reckoning, there are between 1,500 and 2,500 people living with GSDIa in the U.S. out of an estimated global patient population of 6,000 to 8,000 “within commercially accessible geographies,” the company said in an Aug. 19 release.” 
  • HCPLive tells us,
    • “The U.S. Food and Drug Administration (FDA) has approved Glenmark Pharmaceuticals’ fluticasone propionate nasal spray, USP, 0.05 mg (50 mcg)/spray, a generic version of Haleon’s Flonase Nasal Spray indicated for nasal symptoms of allergic rhinitis, the company announced on August 20, 2026.¹
    • “The approval of fluticasone propionate nasal spray, USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area,” said Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals. “We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.” * * *
    • “FDA approval was secured through the bioequivalence pathway, so no independent clinical efficacy or safety program accompanied authorization beyond equivalence to the reference product.” * * *
    • “Distribution will be handled by Glenmark Pharmaceuticals Inc., USA, while pricing and launch timing were not disclosed.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A growing number of Americans say their cannabis use is problematic, according to a large new study released Wednesday.
    • “The study, based on nationally representative data of U.S. adults, found that more than 9 percent of the men — or almost 1 in 10 — reported symptoms of cannabis use disorder in 2024, up from about 7 percent in 2021. The prevalence of cannabis use disorder also rose among women, increasing to nearly 6 percent in 2024, up from about 5 percent in 2021. Symptoms of the disorder include not being able to cut back or quit, or continuing to use the drug despite it leading to interpersonal problems.
    • “The notion that cannabis is not addictive may basically be incorrect,” said Dr. Nora D. Volkow, the director of the National Institute on Drug Abuse and the paper’s senior author.”
  • and
    • “There is no one-size-fits-all approach to managing treatment-resistant depression.
    • “At the UC Davis clinic, if patients don’t improve after trying two antidepressants in succession and undergoing psychotherapy, they may be prescribed a low dose of an additional drug such as an atypical antipsychotic or lithium, Dr. Debra Kahn, director of the Advanced Psychiatric Therapeutics Clinic at UC Davis Health said. Clinicians will ensure that medical problems that could be contributing to symptoms are addressed, too.
    • “One additional therapy that has been shown to help people with treatment-resistant depression is transcranial magnetic stimulation, or T.M.S., which was cleared by the U.S. Food and Drug Administration to treat depression in 2008, Dr. Kahn said. It uses magnetic pulses to stimulate parts of the brain to release mood-boosting chemicals including norepinephrine, dopamine and serotonin, she said.
    • “T.M.S. is tolerated well and has no long-term serious side effects, Dr. Kahn said. * * *
    • “Ketamine, an anesthetic commonly used in surgery, is increasingly used to address treatment-resistant depression. In 2019, the FDA approved Spravato, an intranasal spray containing esketamine. In a 2019 trial, 52.5 percent of patients with treatment-resistant depression who took esketamine with an antidepressant for 28 days experienced a significant resolution of their symptoms compared with about 31 percent of people who took an antidepressant with a placebo.” * * *
    • [T]here is unlikely to be one “magic pill” that cures treatment-resistant depression, Dr. Kahn said. People may benefit from a combination of approaches, and they may also need to combine treatments with lifestyle changes.”
  • MedPage Today tells us,
    • “The relationship between physical activity and dementia risk may depend on whether the activity is recreational exercise or job-related labor, a study of more than 4.2 million people suggested.
    • “High physical activity levels were linked to a 20% lower risk of all-cause dementia (relative risk [RR] 0.80, 95% CI 0.75-0.86) over 10 years compared with the lowest level of physical activity, reported Natan Feter, PhD, of the University of Southern California in Los Angeles, and colleagues in a systematic review and meta-analysis.
    • “Leisure-time activities like walking, running, swimming, cycling, or playing sports followed a similar pattern and were tied to lower dementia risk (RR 0.76, 95% CI 0.65-0.88), the researchers wrote in Lancet Public Healthopens in a new tab or window. Household physical activity also appeared beneficial, but evidence was from a single study.”
  • and
    • “A recent report advocated against using BMI as a standalone tool in measuring health risk.
    • “Longitudinal data suggested that high waist circumference was associated with elevated mortality risks, while high BMI was tied to lower mortality risks, among older adults.
    • “Underweight status was associated with a higher mortality risk compared with normal weight in both men and women, regardless of waist circumference.”
  • The American Medical Association lets us know “what doctors want patients to know about mosquito bites.
    • “Mosquito bites spark immune reactions from itchy bumps to Skeeter syndrome and severe illnesses, but prevention and knowing warning signs can reduce risks.”
  • Cardiovascular Business informs us
    • “Transcatheter aortic valve replacement (TAVR) continues to gain momentum as a go-to treatment option for severe, symptomatic aortic stenosis. However, surgical aortic valve replacement (SAVR) remains a significantly safer option for patients 60 years old and younger, researchers confirmed in a new study published in JTCVS Open.[1]
    • “Current guidelines recommend SAVR for patients younger than 65 years, yet an increasing number of younger patients are undergoing TAVR with uncertain long-term results,” wrote first author Jessan A. Jishu, MD, with the Tulane University School of Medicine, and colleagues. “Given this lack of clarity and growing real-world adoption of TAVR among younger individuals, this study uses a large-scale database representative of practices in the United States to confirm the findings from these previous studies by assessing short- and long-term outcomes of SAVR versus TAVR in patients younger than 60 years, a population in whom long-term durability and reintervention risk are of particular concern.”
    • “Jishu et al. explored the TriNetX database, exploring real-world data from nearly 10,000 patients who underwent TAVR or SAVR from 2006 to 2025. Approximately 80% of patients were treated with SAVR, but TAVR grew more common from 2020 to the end of the study.”
  • and
    • “A Cedars-Sinai Health Sciences University-led study has identified molecular changes that appear to trigger atherosclerosis years before inflammation, sharing their findings in European Heart Journal.
    • “The group believes this could a key discovery in the development of next-generation early prevention therapies. 
    • “The study’s authors found previously unrecognized molecular pathways and a possible master regulator protein called MLXIPL that could become future targets for clinicians working to stop plaque from ever developing.
    • “We analyzed proteins and gene activity in coronary artery tissue from young adults who died of trauma and had no known coronary artery disease, and we found that more than half already had preclinical atherosclerosis,” first author Sarah Parker, PhD, an associate professor of cardiology and biomedical sciences and co-director of the proteomics and metabolomics core at Cedars-Sinai Health Sciences University, said in a statement. “This suggests that changes in cellular metabolism and communication begin before the inflammation long considered a hallmark of the disease.”
    • “Parker said this research provides a direct picture of what is happening inside the artery wall and may explain why some people are more vulnerable to heart disease than others.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of ifezuntrigene inilparvovec (uniQure N.V.) for Huntington’s disease. This therapy is also known as AMT-130.
    • “The assessment will be publicly discussed during a meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in March 2027, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
    • “Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including relevant patient groups, and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.”  

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

  • The Wall Street Journal reports,
    • “Surging healthcare costs are walloping U.S. workers, and they will only worsen next year. For 2027, employers may be facing the biggest health-insurance increase in at least two decades.
    • “Americans with workplace coverage are expected to spend an average $5,297 this year on healthcare, $388 more than 2025, according to a new estimate from benefits-consulting firm Aon. The spending represents a combination of payroll deductions for premiums and out-of-pocket charges like deductibles and copays.
    • “The burden is likely to grow significantly next year, when U.S. employers expect their healthcare costs to go up by 11.1%, according to a new survey from WTW, another big benefits consultant—the steepest rise in more than 20 years.
    • “That would represent the fifth year of escalating increases, according to WTW. “Employers are telling us that this is utterly unsustainable,” said Jeff Levin-Scherz, population-health leader at WTW. Expensive cancer treatments and wide adoption of weight-loss drugs are among the factors pushing up spending.”
  • and
    • “Costco sells its dedicated members everything from travel packages to gasoline. Now the retail giant is gearing up to enter a huge new market: Medicare. 
    • “The warehouse chain plans a limited rollout of Costco-branded Medicare plans, working with SCAN Group, a nonprofit insurer. Nationally, Medicare is a more than $600 billion business for insurers, but the two companies said they would start by selling their jointly named Medicare Advantage products in two states, and a Medicare supplement in a third. 
    • “SCAN and Costco executives said the three target markets include around five million Medicare enrollees but declined to disclose exact locations or timing, citing regulatory limits on disclosure pending approval by the Medicare agency.
    • “SCAN is based in Long Beach, Calif., and Southern California is a core market for the nonprofit, which focuses on Medicare and has about 460,000 members. SCAN also offers Medicare Advantage plans in Arizona, Nevada, New Mexico, Texas and Washington state.”
  • Modern Healthcare adds,
    • “Centene is scaling back its Medicare Advantage presence next year as the health insurance company looks to cut costs. 
    • “The insurer plans to completely withdraw from Oklahoma, Tennessee and Hawaii, according to a notice the company distributed to third-party marketing organizations last week.
    • “Centene is also preparing to exit at least 158 counties and cancel 133 Medicare Advantage plans, according to a Modern Healthcare analysis. Modern Healthcare compared the company’s list of available policies for 2027 to the Centers for Medicare and Medicaid Services enrollment file for this month.
    • “The cancellations would drive about a third of Centene’s Medicare Advantage membership, or more than 340,300 enrollees, to shop for new coverage, according to the Modern Healthcare analysis. Members may have alternative Centene plans from which to choose.” 
       
  • The Health Care Cost Institute released a report about the “Effects of vertical integration on providers’ billing and practice patterns in Medicare (2018-2022)”
  • Fierce Healthcare notes,
    • “The blockbuster success of GLP-1 weight loss drugs has caused major ripple effects across healthcare and pharma, representing a significant growth engine for drugmakers but a cost challenge for payers.
    • “GLP-1s are also potentially disrupting a healthcare system built around treating obesity-related complications, forcing providers, insurers and investors to rethink where future revenue and growth will come from, according to a new report from Wells Fargo.
    • “For decades, the healthcare industry has built service lines, reimbursement models and care pathways around the downstream consequences of obesity. Diabetes clinics, cardiology service lines, sleep medicine, orthopedics, bariatric surgery, pharmacy and chronic disease management have all grown inside a system where obesity was widespread, persistent and often untreated.
    • “GLP-1s may be starting to upend that model as the growing use of obesity drugs begins to influence utilization patterns, hospital economics, pharmaceutical R&D and long-term healthcare spending, wrote Robin Wenzel, head of Wells Fargo Industry Insights and John Teasley, market executive, Wells Fargo Healthcare Banking, in the report.
    • “The latest data from the Centers for Disease Control and Prevention and the National Center for Health Statistics indicates that 40.3% of U.S. adults have obesity, and 9.4%, roughly one in ten, have severe obesity. That makes obesity not an outlier, but a baseline condition around which much of U.S. healthcare now operates, the report authors assert.
    • “GLP-1 drugs for weight management move the management of obesity upstream, to prevention in the context of a system designed around late-stage disease. That puts traditional obesity-related service lines, and healthcare’s obesity revenue engine, under pressure, according to the report.”
  • Beckers Hospital Review points out how 14 large health systems performed financially during the three months ended June 30, and tells us,
    • “New CMS data shows emergency department visit times climbed in the vast majority of states compared with the same period last year, though wide variation persists across the country.
    • “The agency’s “Timely and Effective Care” dataset covers children and adults treated at hospitals paid under the Inpatient Prospective Payment System or Outpatient Prospective Payment System, as well as those that voluntarily report data on relevant measures. Data was collected in the 12-month period ending Sept. 30, 2025. Learn more about the methodology here.
    • :Nationwide, the median time patients spent in the ED was 162 minutes for the 12-month period ending September 2025, stable from the same period a year prior, according to CMS data.:
  • Healthcare Dive notes,
    • “Name: Dr. Shantanu Nundy
    • “Previous title: Executive vice president of care delivery and chief health officer, Accolade
    • “New title: Chief medical officer, Humana
    • “Nundy will become Humana’s new CMO effective Aug. 31, the Kentucky-based insurer announced Thursday.
    • “He’s replacing Kate Goodrich, who served as CMO from 2022 to October 2025, when she left for a role in the health services division of Humana’s rival insurer UnitedHealth. The CMO post has sat empty since.
    • “As CMO, Nundy will help design Humana’s products, platforms and use of artificial intelligence with a clinical eye, according to the release.”
  • and
    • “Name: Arun Kumar Bhaskara-Baba
    • “Previous title: Chief information officer, Honeywell Aerospace and Defense
    • “New title: Chief information officer, Mayo Clinic
    • “Bhaskara-Baba joined Mayo Clinic as CIO in May, the Minnesota-based health system confirmed in a statement. He’s at the helm of Mayo’s information technology systems across its network of 16 hospitals and 45 multispecialty clinics.
    • “Bhaskara-Baba is succeeding Cris Ross, who retired in 2024 after 12 years in the role.
    • “Bhaskara-Baba brings more than 25 years of tech experience to the role. He joins Mayo from Honeywell Aerospace and Defense, where he directed digital strategy and scaled the company’s artificial intelligence capabilities as CIO.”
  • Fierce Healthcare informs us,
    • “Cityblock Health, a company primarily focused on providing care for urban Medicaid and dual-eligible members, plans to acquire Homeward Health to expand deep into rural markets, the company announced Thursday.
    • “Combined, the two companies will serve nearly 250,000 people and are positioned to reach the 120 million people receiving government-funded healthcare in the U.S., Toyin Ajayi, Cityblock Health CEO and co-founder, wrote in a blog post.
    • “Cityblock said it signed a definitive agreement to acquire Homeward in an all-stock transaction. Financial details of the deal were not disclosed.”
  • and
    • “Carrum Health, a company with value-based Centers of Excellence for employers, is teaming up with Included Health, a virtual care and health navigation company working with employers and plans.
    • “Carrum’s Centers of Excellence network for specialty care will be embedded directly into Included Health’s Alternative Health Plan to help connect members to high-quality specialty care with more predictable costs. The partners will connect plan design, navigation and value-based care into one coordinated experience. 
    • “As employers face steep healthcare cost increases, specialty care often drives a lot of healthcare spending. From 2023 to 2025, the U.S. saw the highest three-year stretch of healthcare cost growth in over a decade, according to the Business Group on Health. The Carrum integration will deliver greater cost predictability with bundled rates, outcomes accountability and streamlined contracting.”
  • Healthcare Dive adds,
    • “Healthcare revenue cycle management company R1 has agreed to acquire Humata Health, a company specializing in artificial intelligence-powered prior authorizations.
    • “R1 is banking that Humata’s AI expertise will help it streamline the preapproval process required by insurers for certain medical treatments, and further its goal of automating how healthcare providers get paid for their services.
    • “The acquisition is expected to close in the third quarter this year, after which Humata’s team will start integrating its technology into R1’s revenue cycle platform. An R1 spokesperson declined to share the financial terms of the deal.”

Monday report

David Ermer–ACA, CDC, CMS, FDA, Medical / Rx research, Mental health care, OPM, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    •  “In the chapel of a homeless shelter, health secretary Robert F. Kennedy Jr. stood behind a lectern with a “Cancel Corruption” sign and lambasted local officials for mishandling the city’s homelessness and substance use crisis.
    • “Just 24 hours earlier, Kennedy was in the Oval Office, standing alongside President Trump, as the president signed an executive order calling for major changes to childhood vaccinations.
    • “The change in tone — from day to day and coast to coast — shows how Kennedy’s sprawling political messages tied to his Make America Healthy Again movement vary depending on the audience he is in front of.”
    • “In Los Angeles, Kennedy kept the message fairly local, speaking before conservative city officials and a mission group of roughly a hundred teenagers and praising the shelter he was visiting. But from Washington, Kennedy has become a spokesman of the administration’s more far-reaching policies: fewer vaccines for kids and more regulation of food additives, both announced on Monday from the nation’s capital, before he headed West.” 
  • Per an HHS news release,
    • The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today announced $96.7 million in grants and cooperative agreements to strengthen behavioral health services and supports across the country. The awards provide funding for a range of behavioral health services and initiatives, including services for people with serious mental illness who are homeless, suicide prevention and early intervention, substance use disorder treatment, training and technical assistance, peer support, and disaster-related emotional support.
    • “Every American deserves the opportunity to recover and live with dignity,” said HHS Secretary Robert F. Kennedy, Jr. “These investments will expand access to treatment, strengthen behavioral health services, and help more people move from crisis to recovery. That is how we restore health, rebuild lives, and strengthen our communities.”
  • Meritalk interviews the U.S. Office of Personnel Management’s Chief Information Officer Adam Starr.
    • “As CIO roles become more strategic, OPM CIO Adam Starr says agencies need to give technologists room to move faster, embed AI and security into the business, and create a culture that rewards measured risk.”
  • Federal News Network relates,
    • “The Defense Logistics Agency’s five-year IT modernization journey reached an important milestone earlier this summer.
    • “DLA moved its catalog system off a 35-year-old COBOL-based system and onto a new modern platform.
    • “Adarryl Roberts, DLA’s chief information officer, said the agency will now have a system that will allow it to process data and requests much faster.”
  • FEHBlog observation — This is another example of IT modernization that causes the FEHBlog to wonder why OPM cannot convert its outdated CLER system to the modern HIPAA 820 electronic transaction that allows carriers to reconcile premiums at the individual enrollee level.
  • Fierce Healthcare tells us,
    • “Amid instability in the Affordable Care Act marketplaces, proponents of ICHRA have suggested that these models could help support risk pools. A new survey from the HRA Council adds to the body of evidence on the matter. 
    • “The council, a nonpartisan organization that pushes for expanded coverage options, released its latest look at trends around individual coverage reimbursement arrangements, or ICHRA, and found that a growing number of larger employers are considering it as an option.
    • “The larger employee base from these firms could bring more younger, healthier individuals into the market, adding greater stability to the risk pools that would be felt on the exchanges, according to the report.”

From the Food and Drug Administration front,

  • The Hill reports,
    • “More cases have been linked to outbreaks of cyclospora that do not have an identified source, according to the Food and Drug Administration. The outbreak linked to iceberg lettuce, meanwhile, has expanded to two additional states. 
    • “There have been nearly 14,000 cases of domestically acquired cyclospora confirmed in the U.S. since May this year, the Centers for Disease Control and Prevention report. That’s well over the roughly 1,180 cases reported from May through August last year.
    • :Of this year’s cases, at least 9,480 were reported in the 17 states connected to the cyclospora outbreak traced back to iceberg lettuce, according to the FDA and the CDC. Two states, Maine and Massachusetts, were added to that tally late last week.
    • At least some of the nation’s cases are also linked to the ongoing cyclospora outbreaks that the FDA has been investigating. 
    • “There are seven active investigations into cyclospora outbreaks, the FDA’s tracking shows. Three – sickening 18, eight and two people, respectively – are listed as ended. Only the outbreak linked to iceberg lettuce has an identified source.
    • “Two outbreaks have grown, according to the FDA. One, which was first reported in early August, has grown to 11 cases. Another, from late July, has grown to 172 cases, up from 115. The FDA continues to conduct traceback in both outbreaks, as well as three other still active outbreaks.
    • “We may never know the cause of the outbreak. Because of how long it can take for people to experience symptoms, and the difficulties of sequencing cyclospora, investigations can “take a significant amount of time,” Gwen Biggerstaff, the deputy director of the CDC’s Division of Foodborne, Waterborne, and Environmental Diseases, previously explained.”
  • MedTech Dive relates,
    • “Johnson & Johnson said Monday its Monarch bronchoscopy robot for lung cancer diagnosis received Food and Drug Administration clearance for a software update that adds several new features to the platform, including artificial intelligence tools designed to make pre-procedure planning more intuitive.
    • “Other improvements broaden compatibility with commonly used imaging systems and support navigation and targeting to help physicians address anatomical changes that can occur during the procedure.
    • “The Quest 3 update is the Monarch system’s fourth major software launch in the past 18 months, according to J&J.”
  • and
    • “The Food and Drug Administration has selected Cadence, a software company that makes an artificial intelligence-assisted tool for hypertension management, as the second company for its digital health pilot. 
    • “The Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, exempts certain digital health devices from FDA premarket authorization requirements while allowing companies to collect real-world data through a related Medicare program. 
    • “Cadence, which announced the FDA’s selection last week, plans to report real-world data related to the safety, performance and patient outcomes associated with its device to help inform how clinical AI systems are built and regulated in the future.”

From the judicial front,

  • On August 3, 2026, a Title VII class action was filed in the U.S. District Court for the District of Columbia against OPM Director Scott Kupor and his agency due to OPM’s exclusion of gender affirming care in the FEHB and PSHB programs.  On August 14, the Chief Judge granted the named plaintiffs’ motion to use pseudonyms and seal certain identifying information. On August 17, the District Court’s Clerk assigned the case to U.S. District Judge Amit T. Mehta.

From the public health and medical / research front,

  • The Washington Post reports,
    • “More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
    • “Starting this week, that grueling regimen can be reduced to just one shot a week.
    • “Novo Nordisk announced Tuesday that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
    • More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
    • “Starting this week, that grueling regimen can be reduced to just one shot a week.
    • “The appeal of reducing 365 shots a year to 52 is obvious: greater convenience, less pain. Novo Nordisk says removing the daily requirement can create “a routine that feels more manageable.” 
    • “But there are other issues to keep in mind — most importantly, the risk of hypoglycemia, or low blood sugar, which Novo Nordisk said was a common adverse reaction in Awiqli clinical trials. Hypoglycemia can make people feel shaky, irritable, and, if the blood sugar gets very low, confused. It can be dangerous and can even cause death if it gets excessively low.
    • “Novo Nordisk announced Tuesday [August 11, 2026] that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
    • “Another factor is access: It is not yet clear which insurance plans will cover Awiqli and whether they will require patients to jump through hoops to qualify for coverage.”
  • MedPage Today relates,
    • “Using a panel of 11 genes linked to pediatric cancer predisposition syndromes, researchers found pathogenic or likely pathogenic variants in 7% of newborns who later developed a solid or brain tumor.
    • “Targeted sequencing of this panel would identify approximately 1/27,000 infants who will develop cancer by age 8 years in the setting of a genetic cancer predisposition syndrome.
    • “Researchers said it is feasible to conduct genomic newborn screening universally.” * * *
    • “[E]arly identification of these children could alter their survival outcomes, Diller and team noted.
    • “It’s become clear over the past few decades that at least 10% or more of kids who develop cancer have genetic predisposition to cancer, and a good chunk of those kids are diagnosed in the first few years of life,” Diller told MedPage Today. “It predisposes them to very-early-onset cancers. So the clinical problem is, can we do anything other than wait for them to develop their cancers?”
  • Health Day tells us,
    • “Ultra-processed foods might be linked to a higher risk of prostate cancer, a new study says.
    • “Men who ate the most ultra-processed foods had as much as a 34% higher risk of prostate cancer, compared to those who ate less, researchers reported recently in theAmerican Journal of Medicine.
    • “Among adult men in this nationally representative U.S. population, those who consumed higher amounts of UPFs had significantly higher risks of the subsequent development of prostate cancer,” said senior researcher Dr. Charles Hennekens, a professor of medicine and preventive medicine at Florida Atlantic University.
    • “These findings add to emerging evidence that UPFs have major adverse health effects and underscore the need for large-scale observational studies and randomized trials to adequately test the hypothesis,” Hennekens said in a news release.”
  • and
    • “A person’s sleep patterns could be an early sign of Alzheimer’s disease, a new study says.
    • “A greater number of micro-awakenings during sleep is linked to a greater genetic risk for Alzheimer’s, researchers reported recently in the journal Sleep.
    • “In fact, more frequent micro-awakenings go hand in hand with that genetic risk, long before any memory problems arise, according to a team from the University of Liege in Belgium. 
    • “Sleep could become an accessible marker for the early identification of vulnerable individuals,” senior researcher Gilles Vandewalle said in a news release.
    • “It’s well-known that people with Alzheimer’s have sleep problems, but sleep hasn’t been established as an early indicator of the disease, researchers noted.”
  • The Wall Street Journal informs us,
    • “AstraZeneca AZN  said it is ending the Phase 3 trial of volrustomig plus chemotherapy for metastatic non-small-cell lung cancer.
    • “The Cambridge-based pharmaceutical company said Monday that the decision is based on the recommendation of the Independent Data Monitoring Committee after a planned review of trial data.
    • “The committee concluded that the volrustomig combination was unlikely to reach either of the primary endpoints for the drug in the eVolve-Lung02 trial.” * * *
    • “The other Phase 3 volrustomig trials will continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.
    • “Separately, AstraZeneca said Tagrisso plus Orpathys showed a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival in a Phase 3 trial in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer.” * * *
    • “The company said this was the first global Phase 3 trial to show significant progression-free and overall survival benefits in this setting.
    • “Tagrisso plus Orpathys is being jointly developed with Hutchmed, but is being solely commercialized by AstraZeneca.
    • “AstraZeneca also said a Phase 3 trial of Enhertu showed a significant and clinically meaningful improvement in progression-free survival as a treatment for unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small-cell lung cancer.”
  • BioPharma Dive points out,
    • “Shares for Argenx soared over 13% Monday morning after the company announced positive data from a Phase 3 trial for a rare autoimmune condition that could expand use of its blockbuster drug Vyvgart. 
    • “The Dutch biopharmaceutical company said Monday an under-the-skin injection version of Vyvgart, called Vyvgart Hytrulo, met its primary endpoint in a late-stage combined study of people with myositis, a rare autoimmune disease that attacks the muscles and has limited treatments. The company said that Vyvgart, when compared to placebo, showed improvements in two subsets of the disease, as measured by a scale evaluating muscle strength and physical health known as Total Improvement Score, or TIS.”
  • and
    • “EyePoint, a Boston-area biotechnology company, lost nearly a billion dollars in market value Monday after its main drug failed to hit the central goal of a key clinical trial.
    • “Titled LUGANO, the trial enrolled roughly 400 people with the less common “wet” form of age-related macular degeneration, meaning they have impaired vision because of abnormal, fluid-leaking blood vessels in their eyes. They received inside-the-eye injections of either “aflibercept,” the active ingredient in Regeneron Pharmaceuticals’ blockbuster medicine Eylea, or EyePoint’s drug, which the company has branded as Durayvu.
    • “Researchers then evaluated these participants for a little over a year, with a particular focus on any changes in average “best-corrected visual acuity” — a measure of how clearly a person, when outfitted with optimal prescription lenses, can read the kind of standard eye chart found in an optometrist office. EyePoint has now revealed that, on that measure, across the trial’s full dataset, its drug didn’t prove “non-inferior” to aflibercept.
    • “The company largely blamed the failure on an “asymmetric cohort” of nine patients in the Durayvu-treated group, who had vision loss — or a dropoff of at least 15 letters on the eye exam — that was “unrelated to wet AMD.” According to EyePoint, an after-the-fact analysis found the drug would have achieved non-inferiority had that group been excluded.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente reported nearly $1.7 billion in operating income (4.6% operating margin) during the second quarter of 2026, a more than $600 million improvement over the same period in 2025. 
    • “The country’s largest nonprofit health system, in a quarterly financial update shared Friday that precedes its more granular regulatory filing, outlined $35.6 billion in operating revenues, a 10.9% year-over-year increase, and nearly $34 billion in operating expenses, a 9.3% year-over-year increase.
    • “Kaiser noted that its structure as a membership-based, premiums-collecting integrated health system typically yields stronger operating income in the first half of the calendar year “due to health plan enrollment cycles,” moderating later on “as care utilization, labor costs, and other expenses increase while revenue stays relatively flat.”
    • “The quarter’s performance follows an opening frame in which the organization’s $711 million operating income (2.1% operating margin) reflected a pullback from early 2025’s $932 million operating gain (2.9% operating margin), due in part to a major month-long work strike. Year to date, that still places Kaiser and its subsidiaries about $400 million ahead of 2025. 
    • “In today’s complex health care environment, positive operating performance helps us make care more affordable, invest in our future, and expand access to value-based care,” Kaiser Permanente Chair and CEO Greg A. Adams said in a statement. “Together, Kaiser Permanente and Risant Health are helping more people benefit from evidence-based, coordinated care that improves quality, enhances the patient experience, and makes high-quality care more accessible and affordable. I’m grateful to our employees and physicians for bringing our mission to life every day.”
  • Beckers Payer Issues relates,
    • “Blue Cross Blue Shield of Massachusetts earned $83.4 million in after-tax second-quarter profit. 
    • “This was made up of $35.7 million in operating and other income, as well as $47.7 million in investment income. The insurer’s revenue was $2.7 billion, marking a net margin of 3%. During the same period in 2025, BCBS Massachusetts had a $129.7 million loss on revenue of $2.6 billion.
    • “Since the beginning of the year, after-tax net income has been $142.9 million with revenue at $5.4 billion, a 2.7% net margin. The results include a premium deficiency reserve.
    • “After two consecutive years of record losses, we are also laser focused on restoring our company’s financial health,” Executive Vice President and CFO Ruby Kam said in an Aug. 14 news release. “We are doing this by carefully managing our own administrative costs and making necessary adjustments to our pricing and benefits.”
  • Healthcare Dive tells us,
    • “Universal Health Services has completed its $835 million acquisition of online therapy provider Talkspace, bolstering the for-profit system’s already extensive behavioral health offerings.
    • “The deal closed Monday five months following its announcement, after the companies secured necessary regulatory approvals.
    • “With the buy, UHS will be able to provide a full range of behavioral health services, including inpatient, intensive outpatient, partial hospitalization, therapy sessions and virtual assessments.”
  • Beckers Clinical Leadership adds,
    • “Salt Lake City-based Intermountain Health is approaching behavioral health access challenges by first addressing one quality concern in particular: whether patients are actually getting better.
    • “That’s the premise behind the health system’s push to embed measurement-based care across its behavioral health service line, Tammer Attallah, executive clinical director of Intermountain’s behavioral health clinical program, told Becker’s. The nonprofit system has locations in six primary states and additional operations across the western U.S., operating 34 hospitals and more than 400 clinics.
    • “We want more patients to get better faster. That’s all,” he said. “It’s as simple as that.” 
  • Beckers Physician Leadership informs us,
    • “Three physician leaders shared what they believe healthcare organizations and the system as a whole need to stop asking of physicians, pointing to burdensome technology, systemic dysfunction and workflows that pull clinicians away from patient care. 
    • “James Augustine, MD. Medical Director for Lee County EMS (Fort Myers, Fla.): Mandated use of very unfriendly computer systems, which don’t contribute to good practice.
    • “Peter Bravos, MD. Chief Medical Officer of Sutter Health’s Surgery Center Division (Yuba City, Calif.): Asking physicians to personally absorb systemic dysfunction and calling it resilience. When the schedule is broken, the staffing is thin, and the administrative load keeps climbing, a wellness webinar isn’t a solution. It’s a way of relocating a system’s problem onto the individual and then measuring the individual for how well they cope with it. Resilience was never meant to be a substitute for fixing the conditions that exhaust people. Build systems worthy of the people working in them, and resilience takes care of itself.
    • “Walter Allen Fink, DO. Associate Vice President and Chief Medical Officer UT Health San Antonio: We need to stop putting unnecessary things between physicians and the work they were educated and trained to do.
    • “Too much physician time is spent working around inefficient processes, navigating technology, dealing with fragmented workflows, and doing tasks that do not really require a physician’s expertise.
    • “For me, this is bigger than just reducing administrative burden. We should be designing systems that allow physicians to spend more of their time caring for patients, making complex clinical decisions, talking with patients and families, and improving care.”
  • Fierce Healthcare notes,
    • “Since April, more than 300 enterprise health systems have adopted Abridge’s artificial intelligence-based decision support solution, and the company is now making the tool available to every clinician at its partner health systems.
    • “It’s part of Abridge’s strategy to broadly expand from AI documentation to functioning as an enterprise AI assistant for clinicians.
    • “Adoption of decision support has outpaced anything we’ve shipped before because it feels like a natural extension of Abridge. It understands the context of the patient in front of the clinician, it’s grounded in the evidence they already trust, and it connects to what they want to do next,” Shiv Rao, M.D., CEO and co-founder of Abridge, and a practicing cardiologist, said in a statement.

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The House of Representatives Budget Committee lets us know,
    • “A new report from the Department of Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) finds reforms to Medicaid provider taxes and state-directed payments in The One Big Beautiful Bill will lower health care prices for Americans across the board.
    • “The report projects the reforms will reduce non-Medicaid health care prices by as much as 3.5 percent, generating between $502 billion and $875 billion in savings for taxpayers, families, and businesses over the next decade, with annual savings reaching $100 to $175 billion once the reforms are fully in place.
    • “The savings extend beyond Medicaid: ASPE estimates that every $100 billion in Medicaid savings produces another $29 billion in savings for Medicare and commercial coverage plans, which lowers health care costs and the tax burden for hardworking American families.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced that health systems represented by the past, current, and incoming chair of the American Hospital Association (AHA) have joined the Make Hospital Food Healthier Pledge, strengthening a nationwide effort to improve the quality of food served in America’s hospitals and reinforce the role of nutrition in patient care. Corewell Health in Michigan, Houston Methodist in Texas, and Sanford Health in South Dakota all signed onto the pledge.
    • “Hospitals cannot promote healing while serving food that contributes to chronic disease,” said HHS Secretary Robert F. Kennedy, Jr. “By joining this pledge, these health systems are putting nutrition where it belongs — at the center of patient care. We are working with hospitals across America to serve healthier food, improve patient health, and Make America Healthy Again.”
  • Fierce Healthcare reports,
    • “The Pharmaceutical Care Management Association announced Thursday that its members had reached an agreement with the feds to offer information on cash prices available through TrumpRx.
    • “The commitment encompasses nine of the industry’s leading pharmacy benefit managers, including the “Big Three” in CVS’ Caremark, UnitedHealth Group’s Optum Rx and Cigna’s Express Scripts. Other participants that have signed on include Elevance Health’s CarelonRx, Humana, MedImpact Healthcare Systems, Navitus Health Solutions, Prime Therapeutics, VtylOne and WellDyne.
    • “Members covered by these PBMs will be able to see costs for drugs purchased through TrumpRx when using their plan’s real-time benefit or other pricing tools, PCMA said.”
  • McKnight’s Homecare relates,
    • “In a new memo outlining the National Fraud Enforcement Division’s enforcement priorities in a variety of industries, the Department of Justice called out home health and hospice fraud as an area of focus in the healthcare sector.
    • “National healthcare expenditures are expected to grow from over $3 trillion a year to over $7 trillion, and estimates are that between 3–10% of that amount is lost to fraud,” the Aug. 13 memo from Colin M. McDonald, assistant attorney general, said. “Home health aide and hospice scams directly impact vulnerable elderly Americans and erode patient care.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Aug. 14 released a request for comments through the Office of the National Coordinator for Health IT on a proposed three-year generic clearance to collect routine customer feedback on service delivery and performance related to the Trusted Exchange Framework and Common Agreement. TEFCA is a nationwide network for health information sharing established by ONC to fulfill mandates under the 21st Century Cures Act. HHS said data collection under the clearance would be used to standardize monitoring and performance reports for TEFCA participants. Comments are due 30 days following publication in the Federal Register.”

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

  • Govexec reports,
    • “Federal wildland firefighters will soon have more opportunities to receive hazard pay in connection with their work fighting and preventing wildfires, thanks to newly finalized regulations from the Office of Personnel Management.
    • “Currently, federal firefighters are eligible for hazard pay—a 25% increase over their normal salary—only when working to extinguish an unplanned wildfire. But they do not receive this increased pay when working on prescribed burns, in which officials intentionally ignite decaying forest material in the hopes of mitigating the risk of an uncontrolled wildfire breaking out in the future.
    • “In a new rule published in the Federal Register Friday, OPM finalized its April proposal to expand firefighters’ access to hazard pay to include prescribed burns, effective Sept. 13. The regulation authorizes hazardous duty pay for prescribed burns for firefighters hired under the “General Schedule pay sale, as well as environmental differential pay for those serving under the Federal Wage System.
    • “But OPM noted that the new hazard pay will not be available for every activity associated with a prescribed burn.
  • Also in today’s Federal Register, OPM issued a new direct final rule. Here is the summary and comment information:
    • SUMMARY: Pursuant to the President’s direction in Executive Order 14410, Implementing Schedule Policy/Career in the Excepted Service, the Office of Personnel Management (OPM) is issuing a direct final rule to update and amend obsolete and outdated provisions of the
    • Civil Service Rules that do not substantively affect agency operations.
    • DATES: This rule is effective October 13, 2026, unless significant adverse comments are received by September 14, 2026. If significant adverse comments are received, OPM will withdraw the relevant provisions of this direct final rule.
  • Federal News Network relates,
    • “Retirement is supposed to be the payoff for decades of saving, planning and serving the federal government. But for some federal employees, the first year of retirement can bring surprises they never saw coming, whether that be a delayed pension, a tax bill that looks very different from what they expected, anxiety about spending the money they’ve saved for decades, and decisions that can affect a spouse’s benefits for years to come.
    • “On this episode of Fed Thread [which the article summarizes], we called back our three financial professionals—James Campbell of Federal Employees Benefit Association, Katelyn Murray of RJFS and Serving Those Who Serve, and Chris Campbell of CJC Wealth Management and the DC Society for Financial Awareness—to talk through the financial and psychological traps feds may encounter before or after their last day. Because retirement isn’t just the day your paycheck stops. It’s the beginning of a completely different financial system.”

From the Food and Drug Administration front,

  • The Washington Post informs us,
    • “About 1.5 million dozen white and brown cage-free eggs recalled for potential salmonella contamination have been upgraded to the U.S. Food and Drug Administration’s highest-risk warning. 
    • “The agency reclassified the recall of Midwest Poultry Services eggs to Class I due to the reasonable possibility that exposure to the product would cause serious health issues or death, it said in a safety alert. 
    • “Salmonella is a bacteria that can cause diarrhea, vomiting, fever and stomach pain.
    • “The eggs were available to consumers in Brookshire Grocery stores in Texas, Louisiana, Oklahoma, Arkansas, New Mexico and Mississippi. Other locations include Kroger stores in Texas and Louisiana, as well as other small retail outlets, the FDA said.”
  • The UPI reports,
    • “U.S. health officials said they have begun inspections at the Mexican processing plant of the U.S. food distributor Taylor Farms as they deal with a continuing cyclosporiasis outbreak that has spread across 17 states.
    • “The Food and Drug Administration and the Centers for Disease Control and Prevention announced Thursday they have “initiated an onsite inspection and sampling” at Taylor Farms de Mexico’s facility in Guanajuato, Mexico, located about 185 miles northwest of Mexico City.”
  • The University of Minnesota’s CIDRA adds,
    • “The best-if-used-by dates of recalled iceberg lettuce associated with the massive Cyclospora outbreak have passed, according to an update from the US Food and Drug Administration (FDA) yesterday. This means that Cyclospora-tainted Taylor Farms lettuce should no longer be available at stores and restaurants.” 
  • Radiology Business relates,
    • “The U.S. Food and Drug Administration has approved a new brain imaging agent targeted toward Alzheimer’s, drugmaker Lantheus announced Friday. 
    • “Tauklarify, also known as MK-6240, is a radiodiagnostic agent indicated for PET (positron emission tomography) imaging of adults. Ideal candidates have cognitive impairment, with physicians evaluating them for abnormal buildup of tau—twisted, insoluble protein fibers in brain cells—a potential sign of the neurodegenerative disease. 
    • “Bedford, Massachusetts-based Lantheus—which recently reached a deal to be sold to rival Curius for $8 billion—said the drug’s safety was tested in two clinical trials. Across over 1,700 subjects, researchers reported strong results, with only about less than 1% of subjects experiencing adverse reactions.”

No Surprises Act News

  • The Centers for Medicare and Medicaid Service posted a notice today (Dropbox link) about implementation of changes to the Independent Dispute Resolution Gateway required by a recent final rule.
    • “Organizations and individuals thatprocess disputes, represent parties, or submit IDR web forms in the current Federal IDR process must sign up to manage disputes in the IDR Gateway. If a party uses a third-party administrator or another organization to process disputes, the party does notneed to sign up for the IDR Gateway but must ensure the third-party administrator or organization responsible for managing dispute processing activities signs up for an IDR Gateway account.
    • “Details about signing up for the IDR Gateway are coming soon. Until then, continue using the Federal IDR web.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “Luigi Mangione, whose coldblooded killing of an insurance executive on a Manhattan sidewalk rattled the nation and struck fear into Corporate America, pleaded guilty Friday to two federal stalking charges in the death of UnitedHealthcare leader Brian Thompson.
    • “On the morning of Dec. 4, 2024, I shot Mr. Thompson in Manhattan and he died,” Mangione solemnly told the judge during a court hearing.
    • “Mangione, wearing tan jail garb, told the judge that he spent years enduring severe pain, including a broken back, and witnessed others with similar experiences. He said that after learning of an investor conference, he emailed UnitedHealthcare, posing as an investor at a firm managing over $50 million in assets, to request information about it.
    • “Unlike my previous interactions with insurers, I received an immediate response within an hour,” Mangione added. He said he made part of a gun using a 3-D printer and planned the killing.
    • “U.S. District Judge Margaret Garnett said Mangione faces up to life in prison at his sentencing, which she set for December. Jamie McDonald, the U.S. attorney for the Southern District of New York, said after Friday’s hearing that his office intended to seek the maximum penalty, saying Mangione committed the crime in order to “draw public attention to his dislike of certain businesses.” 
    • “No grievance, political belief or ideological cause can ever justify murder,” McDonald said. “There can be no celebrity in assassination.”
  • FEHBlog observation: Well put observation, Mr. McDonald.
  • Healthcare Dive tells us,
    • “A patient advocacy group is going up against the most powerful doctor’s association in the U.S. in a bid to wrest away its ownership of U.S. medical codes and release them into the public domain.
    • “On Thursday, PatientRightsAdvocate.org sued the American Medical Association, challenging its copyright over the current procedural terminology, or CPT, billing code system, which shapes billions of dollars in healthcare payments every year.
    • “The goal of the lawsuit is to get the codes published online and let the public access them for free, the group, which lobbies for better price transparency in healthcare, said. Currently, the AMA charges licensing fees to retrieve and use CPT codes.”
  • FEHBlog observation — It’s no problem looking up CPT Codes on the internet.

From the public healh and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 14, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Based on multiple data sources, COVID-19 activity is low in many regions but is increasing in the West and South.
    • “RSV activity is very low in most areas of the country.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 101 newly confirmed measles cases nationwide, the US total has now reached 2,566 this year, the Centers for Disease Control and Prevention (CDC) said today in its weekly update.
    • “This is the second straight week of about 100 new cases after previous weeks’ totals of about half that. Most this week’s cases are in Pennsylvania, though Ohio also saw a substantial increase. 
    • “The CDC noted 38 outbreaks, the same as last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level several weeks ago. 
    • “All but 16 of this year’s cases have been locally acquired, with the rest tied to international travel.
    • “Of the 2026 cases, 19% involve children age 5 and under, and 67% involve kids and teens. Seven percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status.”
  • and
    • “A pair of new studies confirm that recently developed immunizations against respiratory syncytial virus (RSV) protect infants in their first year of life. 
    • “The research, including one study conducted in France and another in the United Kingdom, confirm that the immunizations are effective in the real world, not just in carefully supervised clinical trials”
  • MedPage Today relates,
    • “By this time of year, both the FDA and CDC normally have weighed in on fall respiratory virus vaccine recommendations. But given ongoing controversies over vaccination spurred by the Trump administration, a wrench has once again been thrown into the gears of that process.
    • “The FDA has done its part, making recommendations about vaccine composition for influenza vaccines in March, followed by recommendations for COVID shots in May. But the CDC’s Advisory Committee on Immunization Practices (ACIP) hasn’t done its part as it hasn’t held its March or June meetings this year.” * * *
    • But clinicians shouldn’t worry, because medical groups have stepped in to fill the gaps. The IDSA, the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians (AAFP) have issued guidance on fall respiratory virus shots and more, as the Trump administration has also tried to make significant changes to the pediatric immunization schedule.
    • At the same time, insurers have pledged to cover all recommended vaccines without cost-sharing through the end of 2027, Richard Hughes IV, MPH, legal counsel for AAP, said in an email in June.
    • “There are some shades of gray, however, as the FDA approved the first mRNA flu shot (mFlusiva) from Moderna earlier this month. While the company has said its shot — approved for adults 50 and up — should be available for the upcoming 2026-2027 season, it’s unclear whether it will be written into recommendations.”
  • and
    • “GLP-1 agonists and bariatric surgery are top obesity treatments, raising questions of their combined efficacy.
    • “A retrospective study found that patients taking GLP-1 drugs before surgery achieved similar 12-month weight loss as non-users (24% vs 25%).
    • “Treatment groups had comparable outcomes on surgical complications and diabetes control.”
  • Health Exec informs us,
    • “Right now U.S. healthcare has almost everything it needs to eliminate one awful affliction—and then to adapt the resulting victory for going after many others.  
    • “All it would take to set the precedent is responsible AI deployment, attuned government leadership, cross-sector partnerships and generational investments.  
    • “That, and an orchestrated targeting of the low-hanging fruit at hand—cervical cancer.  
    • “The cure-in-waiting for this maddeningly preventable cancer represents a “breakthrough with a failure to follow through,” physician-researchers explain in an article published Aug. 13 in JAMA.  
    • “Erstwhile Surgeon General Special Advisor Adam Beckman, MD, MBA, and co-author Dave Chokshi, MD, MSc, believe cervical cancer is a prime candidate for first dibs because of its 90%-plus early-stage survival rate on top of the near-perfect efficacy of vaccines for human papillomavirus (HPV), which causes many if not most cervical cancers. 
    • “All that’s lacking is the will to “bridge the stubborn gap between what we know and what we do in public health and healthcare,” the researchers write.”
  • Health Day points out,
    • “Taking the stairs instead of the elevator may do more for your health than you think.
    • “A large study published in the American Journal of Cardiovascular Drugs found people who regularly climbed the stairs were 39% less likely to die from cardiovascular disease. And 24% less likely to die from any cause. Their odds of heart attack, stroke and heart failure were also lower.
    • “Taking the stairs is a practical and often overlooked way to build physical activity into daily life,” said senior author Dr. Vassilios Vassiliou, a professor of cardiac medicine at Norwich Medical School at the University of East Anglia in the U.K. “We wanted to better understand how this everyday activity could have life-saving potential.”
  • and
    • “Gambling is a powerful temptation for today’s college students, and those hooked have a greater risk of deeper mental health issues, a new study says.
    • “Student gambling frequently occurs alongside depression, anxiety and substance use, researchers reported recently in the International Journal of Mental Health and Addiction.
    • “What’s interesting about this study is even though mental health concerns were very prominent, students who tended to gamble more were more likely to be experiencing greater levels of problems among a sample that was already experiencing plenty,” said lead researcher Nicholas McAfee, director of the William Magee Center for AOD and Wellness Education at the University of Mississippi.
    • “Gambling is a real concern for college students, given the proliferation of online betting and prediction markets in the United States, researchers said in background notes.”

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

  • The International Foundation of Employee Benefit Plans reports,
    • “U.S. employers project a median health care cost increase of 10% for 2027, according to Health Care Costs Pulse Survey: 2027 Cost Trend, a new survey from the International Foundation of Employee Benefit Plans. A similar International Foundation survey conducted in 2025 also projected a 10% increase for 2026.” 
  • Healthcare Dive adds,
    • “Nearly 4 in 5 U.S. adults said either high insurance premiums or out-of-pocket spending were the most important problem in the healthcare system, according to a Commonwealth Fund survey released Thursday. 
    • “Affordability concerns crossed party and coverage lines. Premiums were the top problem for 45% of Republicans, 44% of Democrats and 42% of independents, while more than 8 in 10 adults with employer, individual or marketplace coverage — as well as uninsured adults — said either premiums or out-of-pocket costs were the biggest issue.
    • “Still, according to the survey, Americans are split over who’s best to tackle the problem. Most respondents said the federal government is best suited to solve high healthcare prices, while Republicans were more likely to say insurance companies were best to address the issue.”
  • FEHBlog observation — Consumers pay insurance premiums and cost sharing but evidently fail to understand that those costs are driven by hospital, doctors and pharmacy charges.
  • In that regards, The Washington Post relates,
    • Prescription drug prices recorded the biggest year-over-year drop in more than 60 years in July, a startling reduction experts chalked up to an array of factors, including more generics and discount GLP-1 weight-loss drugs. 
    • While overall costs for medical services continued to rise, prices for medicinal drugs fell 2.7 percent over the 12 months ending in July, the largest annual drop on record, according to Bureau of Labor Statistics data released Wednesday. Prescription drugs, part of the medicinal drug category, fell by 3.1 percent, the steepest annual decline since March 1963.
  • EBRI calls to our attention,
    • “Plan sponsors that wish to introduce or continue offering health savings account (HSA)-eligible health plans as part of their workplace benefit program can benefit from a long-term view of HSA accountholder behaviors. As such, the Employee Benefit Research Institute (EBRI) has undertaken a series of longitudinal studies from its HSA Database, examining trends in account balances, individual and employer contributions, distributions, invested assets, and account-owner characteristics from 2011‒2024. Such analysis can help plan sponsors, providers, and policymakers better understand strategies that can help improve employee financial wellness.”
    • “HSAs offer a triple tax advantage to accountholders, enabling them to stretch money they save for health care expenses further than they otherwise could. The tax benefits of HSAs are maximized when accountholders contribute the statutory maximum and minimize withdrawals for current medical expenditures — if they are able — and invest their HSA balances in assets other than cash. However, the majority of accountholders appear to use their HSAs to pay for current expenses and do not take complete advantage of the tax benefits HSAs offer. Average contributions are well below the statutory maximum, most accountholders take a distribution from their HSA, and relatively few accountholders invest. We do find that as time goes on, accountholders tend to take fuller advantage of the benefits HSAs offer. And, despite out-of-pocket spending on health care rising by 5.9 percent in 2024, average balances in HSAs increased, rising from $4,747 in the prior year to $5,532. Further, the share of accountholders who invest their HSAs has crept steadily upward since EBRI began analyzing its HSA Database, reaching 18 percent in 2024.”
  • Beckers Hospital Review tells us,
    • “Providence Health Plan will completely shut down after it was unable to reach a deal with a national insurer to operate its Medicare Advantage business.
    • “We are in discussion with regulators about this development and the broader wind-down of Providence’s health plan operations,” a spokesperson for the system told Becker’s. “We will share more details with our members and the public as we are able under applicable regulations.”
    • “In May, the Renton, Wash.-based health system said it would shutter most of its insurance business beginning in 2027 after operating more than 40 years as a regional payer and serving more than 440,000 members. 
    • “At the time, President and CEO Erik Wexler said state and federal regulations and consolidation among large insurers had left Providence “in an untenable situation” and unable to continue operating the health plan.”
  • and
    • “Cleveland Clinic recorded operating income of $245.6 million (5% operating margin) during the second quarter of 2026, down from operating income of $255.3 million (5.6% margin) during the same period last year, according to its Aug. 14 financial report.”
  • and
    • “New Orleans-based Ochsner Health recorded operating income of $32.5 million (0.8% operating margin) in the first half of 2026, up from an operating loss of $42.7 million (-1.1% margin) during the same period last year, according to its Aug. 13 financial report.” 
  • Beckers Physician Leadership points out,
    • “Hollywood, Fla.-based DermCare Management and Dallas-based U.S. Dermatology Partners have partnered to form one of the largest dermatology groups in the U.S. 
    • “The combined company will expand patient access, preserve physician autonomy, support national dermatology clinical trials, improve practice management support and unify culture, according to an Aug. 13 news release from DermCare Management. 
    • “DermCare Management partners with more than 270 dermatology practices, and U.S. Dermatology Partners supports a network of more than 120 locations across nine states.” 

Tuesday report

David Ermer–CDC, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Washington Post reports about the President’s August 10, 2026, executive order on child vaccinations.
    • “Insurers probably would still cover childhood vaccines even if Trump administration officials change the schedule. 
    • “If this EO were to withstand legal scrutiny, it appears insurers should still cover recommended vaccines for free,” Jennifer Kates, a senior vice president at KFF, a health policy research and news organization, wrote in an email. She added that spacing the shots over multiple visits is already an option for parents. 
    • “Major insurers have also previously indicated they would continue to cover vaccines even in the face of potential changes. White House officials told reporters on Monday that they believed health insurers would continue to cover vaccines currently on the childhood immunization schedule regardless of whether recommendations change.”
  • STAT News relates,
    • “As of July 1, eligible Medicare beneficiaries may obtain these medications for a sharply discounted out-of-pocket cost of $50 per month. That is the headline many patients will hear and remember.
    • “What follows, however, is far more complicated. Eligibility depends on a detailed checklist of body mass index thresholds, specific combinations of chronic conditions, and prior treatment histories. Many patients will not absorb these details, and many clinics will need time and effort to interpret them.” * * *
    • “As a result, the administrative workload associated with GLP‑1 prescribing often rivals the clinical work itself, stretching already limited primary care resources and diverting attention from other critical aspects of chronic disease management.
    • “Each step introduces friction — points where patients may be delayed, confused, or lost in the process entirely. Programs that are difficult to navigate tend to benefit those with time, health literacy, and persistent advocacy while leaving behind those who are already at risk of poorer outcomes. A benefit that exists on paper is altogether different from access in practice.
    • “For clinicians, the burden is also real. Primary care is already stretched thin, managing rising patient complexity alongside mounting administrative demands. Many practices will absorb this new Bridge workload, driven, as always, by a commitment to their patients. But that commitment is not an unlimited resource. Each additional administrative layer adds to the strain on a specialty already facing workforce shortages, burnout, and declining morale.
    • “Faced with these demands, some private practices may decide that participation in the Bridge program is simply not sustainable.” 
  • MedTech Dive tells us,
    • “Orthopedics firms are shrugging off worries that a new, mandatory Medicare joint replacement model could drive down implant payments.
    • “The Centers for Medicare and Medicaid Services finalized the Comprehensive Care for Joint Replacement Expanded Model, called CJR-X, as part of its hospital inpatient payments rule at the end of July. CJR-X would go into effect in 2028, making hospitals responsible for more spending on joint replacement surgery and associated costs, including the hospital stay and follow-up care provided in the first 90 days of recovery. Hospitals may be eligible for an additional payment from Medicare, or may be required to repay a portion of a patient’s care, depending on quality and spending. Regulators expect the model to save the government $725 million over five years.”

From the Food and Drug Administration front,

  • Reuters reports,
    • “The U.S. Food and Drug Administration on Tuesday finalized guidance for preparation and ‌packaging of fresh-cut produce, recommending measures such as sanitation control, supplier verification and refrigeration to reduce the risk of foodborne illnesses.
    • “The guidance for ready-to-eat produce comes as ongoing outbreaks of cyclosporiasis and salmonella due to contaminated lettuce and jalapenos ​have sickened thousands of people in the United States.”
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has finalized a new recall related to an issue with certain Johnson & Johnson MedTech introducer sheaths. 
    • “These devices are used to introduce Impella heart pumps to the bodies of patients. Johnson & Johnson MedTech and Oscor, the company’s manufacturing partner, received multiple reports of the sheaths leaking in ways that could result in access-site bleeding. 
    • “If leakage does occur, it would come from the device’s sidearm or under the sheath cap. This issue has only been seen with specific lots of 14 and 23 French introducer kits compatible with the Impella RP Flex with SmartAssist, Impella RP Set with SmartAssist, Impella 5.5 Set with SmartAssist, and Impella CP Set.”
  • and
    • “Bracco Imaging has secured U.S. Food and Drug Administration (FDA) clearance for VueJect, a new ultrasound contrast delivery system built specifically for cardiovascular imaging procedures. This represents the latest addition to Bracco’s contrast-enhanced ultrasound (CEUS) portfolio. 
    • “According to Bracco, VueJect was designed to improve workflow efficiency, provide consistency from one operator to the next and enable the continuous administration of ultrasound contrast agents such as Bracco’s Lumason.” 

From the judicial front,

  • The International Foundation of Employee Benefit Plans notes,
    • “The Federal Trade Commission’s settlements with Caremark Rx and Express Scripts could reshape how pharmacy benefit managers present pricing options to plan sponsors. While the PBMs denied allegations that they inflated insulin costs, the settlement orders require new standard offerings designed to increase transparency, limit member out-of-pocket costs and give plan sponsors clearer alternatives to rebate-driven pricing.
    • “A previous blog covered the FTC orders requiring Caremark Rx and Express Scripts to stop favoring high-list-price versions of drugs over identical low-list-price versions on their standard formularies. This post looks at the settlement terms most relevant to plan sponsors and members.”

From the public health and medical / Rx research front

  • The Washington Post reports,
    • “About 30,000 pounds of Argentine beef has been recalled by the U.S. Agriculture Department because it wasn’t inspected before entering the country. 
    • “The different cuts of raw beef from the company Corte Argentino USA were shipped to retailers and grocery distributors in Florida and Texas. The meat was produced from May 15 to May 20 and had freeze-by dates of Sept. 15-20. 
    • “The recalled meat included cuts of top sirloin and eye round.
    • “The Agriculture Department’s Food and Safety Inspection Service checks imported products for packaging, documentation, condition and contamination. The agency said no confirmed cases of illness have been linked to the products. 
    • “Consumers are advised not to eat the meat, and either discard it or return it for a refund.”
  • MedPage Today relates,
    • “The CDC on Tuesday warned doctors about the risk for severe arboviral neuroinvasive diseaseopens in a new tab or window in patients on B cell-depleting or modulating agents, calling out anti-CD20 monoclonal antibodies in particular.
    • “Published case reports indicate an overall mortality of about 40% for patients on anti-CD20 antibodies with arboviral neuroinvasive disease, and neurologic sequelae were common in survivors. The most common virus involved in the reports was West Nile, but severe cases also involved eastern equine encephalitis, Powassano, La Crosse, and others.
    • “In recent years, a novel clinical presentation of chronic, neurodegenerative encephalitis developing over months to years has been described in at least five patients receiving rituximab who were infected with an orthobunyavirus, including Jamestown Canyon virus, Cache Valley virus, or Potosi virus,” the CDC said in a Health Alert Network advisory.”
  • and
    • “Guidelines recommend individualizing HbA1c goals to health status in older adults with type 2 diabetes.
    • “A review of electronic health records found that most older adults with type 2 diabetes outside target HbA1c goals didn’t receive medication adjustments in the right direction.
    • “Only 17% of below-goal patients had their regimen deintensified, while 33% of above-goal patients had their treatment intensified.”
  • Beckers Hospital Review tells us,
    • “Researchers at Baltimore-based University of Maryland School of Medicine found approximately 5% of adults hospitalized with firearm injuries develop a bacterial infection, with most infections occurring during hospitalization.
    • “The study, published Aug. 3 in JAMA Network Open, used the Premier Healthcare Database to analyze 24,024 adults hospitalized with firearm injuries at 323 hospitals between January 2019 and May 2021. Bacterial infection was defined by positive culture results from any source and antibiotics initiated within 2 days of those results that were continued for at least four days or until discharge.”
  • Healio adds,
    • “Percentages of adolescents who engaged in suicidal thoughts and behavior fell from 2021 to 2025, according to the 2025 National Survey on Drug Use and Health.
    • “These are encouraging trends,” Brandon Johnson, MHS, MCHES, chief, suicide prevention branch, Substance Abuse and Mental Health.”
  • Cardiovascular Business informs us,
    • “Abdominal fat is a more accurate predictor of heart disease than body mass index (BMI) alone, according to new findings published in JACC.[1]
    • “BMI remains the most common way that clinicians determine if an individual is overweight or obese. The team behind this new analysis hoped to learn if taking waist circumference (WC) and waist-to-hip ratio (WHR) into account could lead to better assessments of a person’s risk of developing cardiovascular disease (CVD). 
    • “The study included data from more than 260,000 adults over the age of 20 years old. The median follow-up period was 20 years. 
    • “Among patients with a normal weight as determined bv BMI, 5% had a high WC and 18% had a higher WHR. Among overweight patients, 39% had a high WC and 40% had a high WHR. Finally, among obese patients, 9% had a low WC and 45% had a low WHR.”
  • The New York Times points out “The Best Healthy Eating Advice of 2026 (So Far).”
    • “Frozen yogurt is not exactly a health food.”
    • “Your diet influences your cancer risk.”
    • “Be wary of ‘low-carb’ diets.”
    • “The science of intermittent fasting isn’t as sound as you may think.”
    • “Oats are powerhouses of nutrition.”
    • “There is such a thing as too much protein.”
    • “You should probably try to get more fiber.”
    • “The dangers of alcohol start at one drink per day.”
    • “Don’t pass on peas.”
    • “Sipping warm water before breakfast has benefits, but is not a cure-all.”
  • The latest NIH Research Matters post covers the following topics,
    • Childhood screen detects mental health risks
      • Screening for home and family stresses may help identify children at risk for depression and sleep disorders that traditional adversity screening misses.
      • This type of screening could be used to identify and intervene with children at risk of mental health conditions.
    • Immune cells cross blood-brain barrier during human aging
      • “Researchers found that some of the brain’s immune cells are replaced by immune cells from bone marrow as people age.
      • “The findings suggest that scientists might one day be able to use immune cells born outside the brain to deliver therapies for brain disorders.”
    • Improving Parkinson’s disease treatment
      • “Researchers identified a drug candidate that enhanced effectiveness and reduced side effects of the standard Parkinson’s disease treatment in animal models.
      • “If the drug candidate proves effective in people, it could be an effective way to improve treatment for Parkinson’s disease.”
  • Health Day points out,
    • “Heart health appears to affect brain health among people with a genetic risk for Alzheimer’s disease, a new study says. 
    • “People whose hearts are pumping blood less effectively tend to have brains that are shrinking faster, researchers recently reported in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.
    • “This is true among people who carry APOE-ε4, a genetic variant that is known to increase risk of Alzheimer’s, researchers said.
    • “Our findings suggest that even subtle reductions in cardiac function may have important implications for brain health, particularly among individuals at increased genetic risk for Alzheimer’s disease,” lead researcher Dr. Elizabeth Moore said in a news release. She’s a clinical fellow in neurology at Mass General Brigham in Boston.”
  • and
    • “If you have atrial fibrillation, or A-fib, getting moving may make a real difference.
    • “A-fib is an irregular heartbeat that raises the risk of stroke — and it affects an estimated 10.5 million adults in the U.S. Yet research shows that people with A-fib tend to be less active than the general population.
    • “A new study of more than 87,000 adults found that even a little physical activity was tied to better odds of avoiding stroke and death — and the benefits held up whether or not participants had A-fib.”
  • The New York Times lets us know,
    • “A.I. Is Finding Sperm Where Doctors Couldn’t
    • “New technology may make it easier for men with extremely low sperm counts to have biological children.”

From the U.S. healthcare business front

  • Beckers Hospital Review reports,
    • “Kaiser Permanente has committed up to $32 million to support the expansion of the Hope Emergency Center at Martin Luther King Jr. Community Hospital in Los Angeles.
    • “The commitment includes a $25 million charitable grant, the largest gift in the hospital’s history, along with the purchase and loan of a $7 million modular building to keep emergency care running during construction, according to an Aug. 11 news release. The funding will also support long-term improvements to emergency services in South Los Angeles.”
  • and
    • “Nonprofit systems expand into Pennsylvania as for-profits exit.” * * *
    • “The expansion of large nonprofit systems into Pennsylvania might suggest the state has become more attractive, but worsening conditions are leaving smaller hospitals with fewer options.
    • “I’d actually say it’s less attractive to expand [into Pennsylvania] than in the past,” Ben Gerber, CEO of Peak Health and senior vice president and chief strategy officer of WVU Medicine, told Becker’s. “But the hospitals there are running out of options, and they can’t survive on their own. They need partners with broader scale and capability.
    • “It’s not that it’s become more attractive for us; it’s that it’s become impossible for smaller health systems to continue standing, and someone’s got to step in.” 
  • Beckers Behavioral Health relates,
    • “Smithfield, N.C.-based Johnston Health has the lowest median emergency department visit time for psychiatric and mental health patients.
    • “Becker’s has compiled lists of hospitals and health systems with the shortest and longest emergency department visit times for psychiatric and mental health patients using CMS’ Timely and Effective Care-Hospital data. 
    • “The CDC tracks the median length of stay for ED patients as part of its “timely and effective care” measure set. The data was released May 13 and covers ED visits recorded from July 2024 through June 2025. Measures in this dataset apply to all adults and children treated in hospitals paid under either the inpatient or outpatient prospective payment systems. Learn more about the measures here.
    • “Most hospitals on the list of the shortest visit times are small community or critical access hospitals that may see lower annual ED volumes and patient acuities than facilities operating level 1 or 2 trauma centers. CMS does not include hospitals’ total ED volumes or case mix index in its dataset. To effectively assess ED performance, experts recommend benchmarking against a cohort of similar facilities.
    • [The article identifies] 20 hospitals and health systems with the shortest and longest median ED visit times before leaving the visit, along with the sample size.
  • Fierce Healthcare lets us know,
    • “Health insurers are under significant financial pressure, and the gap between the organizations that are adapting and those that are not is growing, according to a new report.
    • “HealthScape Advisors, an organization under Chartis, released its annual look at health plans’ financial performance and found that the number of plans posting an operating loss has increased over the past several years. In 2023, 54% of health plans reported an operating loss, and that grew to 70% in 2024.
    • “The number of insurers with an operating loss then rose a second time to 73% in 2025, according to the report.
    • “Operating losses are concentrated among regional plans and Blues plans, with 72% of regional insurers and 83% of Blues reporting one in 2025.”
  • MedTech Dive tells us,
    • “Teledyne Technologies said Monday it has agreed to buy Varex Imaging for about $1.1 billion. 
    • “Varex designs, manufactures and sells X-ray imaging components and other products for use in medical and industrial applications. 
    • “Teledyne provides digital imaging technologies for industrial, government and medical use but has minimal overlap between its portfolio and Varex’s products.”
  • Drug Channels blog informs us,
    • “The United States has almost 8,000 fewer retail pharmacies than it did in 2018, and more than 2,000 closed in 2025 alone. Rite Aid has liquidated. Walgreens is working through a multi-year plan to shutter hundreds of stores. CVS has trimmed hundreds more.
    • “Yet total U.S. prescription dispensing revenues for all dispensing formats reached a record $751 billion in 2025, up 10% from 2024.
    • “Record closures and record revenue in the same year may seem contradictory, but national totals obscure very different effects on the community. The impact of the retail pharmacy shakeout on patient access has become geographically K-shaped: dense markets can absorb pharmacy closures with little loss of patient access, while rural communities can lose their only nearby pharmacy.
    • “The economic pressures on pharmacies are similar across the country. The access consequences of a closure are not. [In the article,] we examine what is driving the shakeout and why geography determines which communities can absorb them.

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • The Senate remains in session this evening while it considers Senator Susan Collins substitute amendment #6732 to H.R.6500, the Senate’s legislative vehicle for a Continuing Resolution to fund the federal goverment from October 1, 2026, through December 11, 2026.
  • Roll Call adds,
    • “Sen. Bill Cassidy of Louisiana said Friday he intended to vote to confirm Todd Blanche to be attorney general, ending a weekslong back-and-forth with the White House to win over GOP holdouts.
    • “All eyes were on Cassidy’s Friday morning floor speech after his fellow Republican Sens. Susan Collins of Maine and Lisa Murkowski of Alaska announced they would vote against Blanche, citing myriad concerns such as the Epstein files, the so-called “anti-weaponization” fund and questions of his independence.
    • “With Sen. Mitch McConnell, R-Ky., still absent after a hospitalization, Senate Republicans could afford to lose only two votes in their ranks if all Democrats vote against Blanche. Had Cassidy not supported Blanche, Majority Leader John Thune, R-S.D., would lack the votes to confirm him before the August recess. Now he can move ahead and hold a final vote on the Senate floor.”
  • and
    • “A bipartisan bill aimed at combating hepatitis C is stalled in the Senate due to a high score from the Congressional Budget Office, the bill’s lead sponsor Bill Cassidy, R-La., said on Thursday.
    • “The bill, co-sponsored by Sen Chris Van Hollen, D-Md., proposes a national strategy to reduce hepatitis C infections by providing free medications and expanding testing for high-risk and vulnerable groups.
    • “Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee, is a former liver doctor who spent much of his career treating the disease and has said getting this bill across the finish line is a priority before he leaves Congress in January. But the measure has not advanced since its introduction in June 2025, despite bipartisan interest.
    • “There was a score on it that was a disappointing score, but there’s at least some conversations taking place by some with the CBO to get that re-scored,” Cassidy said Thursday afternoon.
    • “Cassidy’s office would not provide the exact figure for the bill’s estimated cost but did say it was higher than a related CBO estimate last Congress.”
  • Govexec points out, “The Senate on Friday confirmed in a 51-47 party-line vote multiple executive branch nominees, including several involved in government oversight and federal employee matters.” 
  • Per an August 5, 2026, AHIMA news release,
    • “AHIMA, a founding member of the Patient ID Now coalition, applauds the Senate introduction of the Patient Matching and Transparency in Certified Health IT (MATCH IT) Act of 2026 by Senators Mark Warner (D-VA) and Jim Banks (R-IN), a companion bill to H.R.2002 introduced in the US House of Representatives by Representatives Mike Kelly (R-PA) and Bill Foster (D-IL).
    • “The MATCH IT Act addresses the problem of patient misidentification within the healthcare ecosystem. The bill would create an industry standard definition for how patient match rates are measured and would improve standardization of patients’ demographic elements entered into certified health IT products to ensure patients are accurately matched with the correct medical record.”
  • FEHBlog observation: Congress should pass this bill.
  • Per an August 6, 2026, White House news release,
    • President Donald J. Trump and Vice President JD Vance are waging war on the fraudsters and scammers who have looted hardworking Americans for far too long.
    • Today, that war becomes fully transparent at fraud.gov — a new website where Americans can track every action, every takedown, and every dollar recovered as part of the unrelenting effort.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Aug. 7 released a procedural notice on its new pathway to expedite access to certain Food and Drug Administration-designated Class II and Class III devices for Medicare beneficiaries. The Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, is designed to reduce delays between FDA market authorization and Medicare national coverage determinations. CMS is accepting comments on the procedural notice for 60 days following publication in the Federal Register.”
  • Beckers Hospital Review reports,
    • “The U.S. economy lost 23,000 jobs in July, but healthcare kept adding positions, according to the Aug. 7 jobs report from the U.S. Bureau of Labor Statistics.
    • “Here are [three] things to know from the July jobs report:
      • 1. Healthcare employment continued its upward trend in July, adding 22,000 jobs, though that marked a slower pace than the average monthly gain of 36,000 over the prior 12 months.
      • 2. Hospitals were essentially flat in July, dipping by about 400 jobs after adding roughly 9,500 in June. 
      • 3. Ambulatory healthcare services drove most of the sector’s gains, adding 18,100 jobs, including 4,200 in offices of physicians and 4,600 in home health care services. Nursing and residential care facilities added 4,300 jobs. 
  • Per an August 7, 2026, U.S. Postal Service news release,
    • “The U.S. Postal Service today announced its financial results for the third quarter of fiscal year 2026 (Apr. 1, 2026 – Jun. 30, 2026). Controllable loss, which excludes certain expenses that are not controllable by management, was $1.0 billion for the quarter, compared to controllable loss of $1.6 billion for the same quarter last year.
    • “Net loss for the quarter under generally accepted accounting principles (GAAP) totaled $2.5 billion, compared to $3.1 billion for the same quarter last year. This $562 million decrease is attributed to an operating revenue increase of $1.1 billion along with a decrease in workers’ compensation of $416 million. These are partially offset by increases in retirement benefits of $324 million, retiree health benefits of $195 million, and compensation and benefits of $129 million.
    • “Our results this quarter reflect some progress relative to those areas of the business where we can exercise control, namely with revenue generation, cost control and service improvement,” said Postmaster General David Steiner. “Nevertheless, the Postal Service is today continuing to face a severe liquidity crisis, and our financial losses this quarter reflect systemic challenges inherent in our Congressionally established business model and regulatory framework. We are taking responsible steps to conserve cash to extend our operating window, but we require thoughtful legislative and other actions to establish a financially sustainable Postal Service capable of serving the American public far into the future.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “A Food and Drug Administration advisory committee meeting is scheduled for September to evaluate data for Grail’s Galleri multicancer early detection blood test.
    • “Grail launched Galleri as a laboratory developed test in 2021. Designed to detect signals from multiple cancers using a single blood sample, the MCED test hit a setback in February when a clinical trial missed its primary endpoint.
    • “CEO Josh Ofman told analysts on an earnings call this week that Grail continues to expect Galleri to receive FDA approval in the first part of 2027.”
  • Targeted Oncology tells us,
    • “The FDA has granted fast track designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of advanced platinum-resistant ovarian cancer in combination with pembrolizumab (Keytruda), according to a news release from BioInvent International AB.”
  • Fierce Pharma informs us,
    • “Fresenius Kabi voluntarily recalled one lot of morphine sulfate injection due to a labeling mix-up with prefilled syringes of the opioid dilaudid that could trigger an overdose resulting in severe respiratory distress or death.
    • “The recall, issued in a letter dated Aug. 4 and posted to the FDA website, is for a single lot of morphine sulfate marketed as Simplist 2 mg/1 ml that was mislabeled and could contain a prefilled syringe of dilaudid 0.5 mg/0.5 ml.”

No Surprises Act News,

  • The American Hospital Association News reports,
    • “Guidance on the implementation timeline for the No Surprises Act independent dispute resolution operations final rule was released Aug. 7 by the Departments of Labor, Health and Human Services, and the Treasury, along with the Office of Personnel Management. The final rule, issued May 28, was designed to streamline communication between group health plans and health insurance issuers, providers and certified IDR entities, while clarifying timelines and processes. The guidance includes details on applicability dates of certain provisions associated with the final rule, including the stand-alone claim adjustment reason codes and remittance advice remark codes guidance.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 7, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Based on multiple data sources, COVID-19 activity is low in many regions but is increasing in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The American Hospital Association reports,
    • “A study published Aug. 5 by Nature found that COVID-19 infection can reactivate dormant, chronic viruses such as Epstein-Barr and cytomegalovirus. The study found that reactivation is correlated with the severity of the COVID-19 infection. The study included data from more than 1,100 hospitalized patients with COVID-19 and found reactivation of various Herpesviridae and Anelloviridae viruses. Researchers said that reactivation occurred frequently in “immunocompetent” individuals during severe illness.”
  • The University of Minnesota CIDRAP relates,
    • “Working-age adults living with long COVID feel less satisfied with life, experience less happiness, and have less hope, according to a study published this week in BMC Public Health. The paper highlights the association between having long COVID and poorer wellbeing. 
    • “The findings underscore that the burden of long COVID extends beyond clinical health outcomes to encompass how individuals evaluate and experience their lives,” wrote the authors, from Syracuse University in New York.
    • “Long COVID symptoms were significantly associated with lower levels of subjective wellbeing in a dose-dependent manner.”  
    • “The World Health Organization defines long COVID “as the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation.”
  • and
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 94 new measles infections—most of them in Pennsylvania—bringing the US total for the year to 2,465, the agency said in its weekly update.
    • “The numbers likely provide additional data to move the United States toward losing its measles elimination status this year. The nation gained that distinction in 2000, but  has now logged consecutive years of more than 2,200 measles cases (2,289 for all of last year). This year’s total is the highest since 1991.”
  • The Washington Post tells us,
    • “Michigan health officials say new cases of cyclosporiasis are declining in the state hit hardest by an outbreak that has sickened more than 12,000 people and left two dead in the state since June. 
    • “The state’s health department said new case reports are slowing and diarrhea-related emergency department visits are trending downward. The drop in cases prompted officials to lift their broad recommendation to avoid bagged salad mixes. But Michigan continues to recommend avoiding recalled lettuce from Taylor Farms de Mexico sourced from central Mexico.
    • “Michigan officials said they believe most of their exposures took place in late June to early July and that most contaminated produce is probably no longer available for consumption.
    • “Cyclospora infections typically cause symptoms about seven days after exposure, although symptoms can take up to 14 days to appear. The health department said residents can now return to routine food-safety guidance for handling and consuming produce, including lettuce and salad greens.”
  • The AP informs us,
    • “In the past year, the U.S. has seen a jump in frequent marijuana users going to the hospital with a nausea and vomiting condition, according to a report released Thursday.
    • “The abruptness and sustained magnitude of the increase” is largely due to the condition getting its own diagnosis code last fall, which is providing a more accurate picture of what was an underrecognized problem, the authors of the U.S. Centers for Disease Control and Prevention report wrote.
    • “Hospital emergency room diagnoses of the condition, cannabis hyperemesis syndrome, rose 16% from last October to May of this year, federal researchers found.
    • “The syndrome — seen in people who frequently use marijuana, especially smokers — is characterized by recurring nausea, uncontrollable vomiting and excruciating abdominal pain.
    • “Past research has suggested that an estimated 2.75 million Americans suffer from it each year, and that hospital emergency room visits have been rising as daily recreational marijuana use has increased.”
  • MedPage Today points out,
    • “Maintaining three key health factors during midlife — normal blood pressure, no diabetes, and not smoking — was associated with nearly 13 additional dementia-free years, a study of 12,000 people in the U.S. showed.
    • “Individuals who met these criteria at age 55 lived an average 30.1 more years dementia-free, reported Josef Coresh, MD, PhD, of NYU Langone Health in New York City, and co-authors.
    • “Conversely, those who smoked, had hypertension, and had diabetes at age 55 had dementia-free survival of only 17.5 years, Coresh and colleagues wrote in Neurology Open Accessopens in a new tab or window.”
  • and
    • “Low-fat vegan diets can help aid in weight loss, but the mechanisms behind this have been unclear.
    • “Adults on a low-fat vegan diet reduced dietary energy density by 30% compared with controls in a secondary analysis of a randomized trial.
    • “Reductions in dietary energy density were significantly associated with greater weight loss after adjusting for overall energy intake.”
  • Medscape adds,
    • “Adding coronary artery calcium (CAC) scoring to risk estimates helped better identify adults at lower and higher risk for atherosclerotic cardiovascular disease (ASCVD) events. People with no detectable CAC had lower observed risk, while those with CAC had higher observed risk, especially when the decision about starting a statin was uncertain.”
  • Healio notes,
    • “Adults with type 2 diabetes and established CVD had lower risk for CV events with tirzepatide [a/k/a Zepbound] compared with sitagliptin [a/k/a Januvia].
    • “Tirzepatide decreased risk for infections leading to hospital admission.
  • Per Genetic Engineering and Biotechnology News,
    • “For people with severe food allergies, avoiding a trigger food like peanuts or tree nuts can mean constant vigilance. Approximately 8% of children and 10.8% of adults in the United States experience some type of food allergy. Even trace exposures can provoke reactions, and while oral immunotherapy can raise the threshold for some patients, the protection often depends on continued treatment and is associated with disease relapse in many patients. A new study suggests that another route to food tolerance may run through the gut microbiome.
    • “In a small Phase I open-label trial (NCT02960074), researchers at Boston Children’s Hospital tested whether oral encapsulated fecal microbiome transplantation (FMT) could safely increase peanut tolerance in adults with peanut allergy. The work, published in Science Translational Medicine, also used mouse models to probe how donor gut microbes might help restore oral tolerance. The study is titled, “Fecal microbiome transplant in food allergy in humans and mice identifies a role for bile acid metabolites in oral tolerance.”
  • The Wall Street Journal adds,
    • “Artificial-intelligence systems have been displaying some eye-opening new abilities in recent weeks: breaking out of their enclosures, hacking other companies, lying to people. 
    • “And now, for the first time, an AI model has created a new virus. A whole family of them, in fact. 
    • “In a study published in the journal Science, researchers at Stanford University and elsewhere said they successfully directed an AI model to create a collection of simple viruses that only infect bacteria and pose no threat to humans.
    • “In an interview, two of the authors said their research could help develop designer viruses that could be used to eliminate drug-resistant bacteria, which according to the World Health Organization kill millions of people every year.
    • “If we develop responsibly, I think it can lead to tremendous benefits in human health,” said Brian Hie, a computational biologist at Stanford and an author of the study.”

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

  • Fierce Healthcare reports, “Insurers see positive results in managing health costs in Q2.”
    • “The health insurance industry weathered a rough 2025, and the turnaround for some companies through the midpoint has surprised even Wall Street analysts.”
  • Beckers Payer Issues adds,
    • “Clover Health posted a $28 million profit for the second quarter of 2026, according to a recent earnings filing.
    • “During the same period last year, Clover logged a $10.6 million loss. The company had its first profitable quarter in 2024.
    • “Total revenue for the second quarter of 2026 was $743.2 million, up nearly 56% year over year. The company attributed the improved results to membership growth and a disciplined approach to administrative spend.
    • “On June 30, Clover had 157,309 members. The company’s benefit-expense ratio dipped to 87.6% this past quarter from 88.4% during the same time in 2025.”
  • and
    • “CVS Health’s pharmacy benefit manager, CVS Caremark, is bringing on Keith Reynolds as chief growth officer.
    • “Chief Sales Officer Jim Fowler will transition into retirement, according to an Aug. 7 LinkedIn post from Mr. Reynolds.” 
  • Beckers Hospital Review relates,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • [The article identifies] 52 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1
  • Health Exec adds,
    • “When a nursing home closes down, the local population and press often perceive the move as a simple exit from the market due to failing fiscal health. But in about half the cases, additional forces are in play—and “closures” may be, in truth, do-overs of one kind or another. 
    • “Researchers at the University of Massachusetts fill out the picture with facts in a study published July 31 by JAMA Health Forum.
    • “Joohyun Chung, PhD, RN, and colleagues suggest understanding the dynamics behind nursing-home closings is important because such events can disrupt continuity of care, place additional burdens on remaining facilities and disproportionately affect vulnerable populations.” 
  • Fierce Pharma tells us,
    • “Injected weight loss drugs remain favored over newer oral treatments by a significant margin, with Eli Lilly’s Zepbound leading the pack, according to a survey of healthcare specialists by Spherix Global Insights.
    • “In the poll, which includes input from 185 specialists in the United States, 80% were highly satisfied with Zepbound, compared with 59% for Novo Nordisk’s rival injectable, Wegovy. Though it remains early in the launches of Novo’s oral version of Wegovy and Lilly’s GLP-1 pill Foundayo, 48% and 47% of those surveyed were highly satisfied with the newer products, respectively.”
  • and 
    • “Prescriptions for Eli Lilly’s Foundayo continue to build, jumping 16% sequentially to 34,219 the previous week, according to IQVIA data cited by Citi. The oral GLP-1 med has been on a roll lately as it appears to celebrate four weeks of consecutive growth in total scripts. However, as Citi noted, there’s still a potential gap in IQVIA’s capture of telehealth data, and it’s not clear how much of the scripts growth was from IQVIA getting better at including those data, or, if the actual growth was much faster in telehealth channels.
    • “This week, Lilly’s reported Foundayo sales for the second quarter—$98 million in total, including $67 million in the U.S.—disappointed many. As CEO David Ricks noted on an earnings call, Lilly began broad direct-to-consumer marketing to raise consumer awareness after securing commercial access across the three major pharmacy benefit managers in June. Besides, The Medicare GLP-1 Bridge program went live on July 1, offering coverage for certain weight-loss medications, including Foundayo, for a $50 copayment per month. Ilya Yuffa, president of Lilly USA and global customer capabilities, said the company is “starting to see an inflection point on Foundayo now.”
    • “As for Novo Nordisk’s Wegovy pill, total scripts recorded by IQVIA have been largely flat with small upticks in the past two weeks, having reached roughly 172K in the previous week. The oral version of semaglutide now makes up 35% of total Wegovy scripts, which take up about 40.6% of the U.S. obesity market share, as Lilly’s Zepbound remains the leader.” 
  • Fierce Healthcare informs us,
    • “Despite the rapid implementation of artificial intelligence solutions across the healthcare industry, many organizations are still working on establishing necessary infrastructures and governance foundations, a new report from UPMC’s Center for Connected Medicine and KLAS Research found.
    • “Ninety-three percent of respondents report that their organizations deploy third-party AI solutions, though only 44% have a dedicated data platform or environment for tool testing. But 92% of respondents report testing third-party tools prior to deployment.
    • “What’s emerging from this research is a clear recognition that implementation is only the first step,” said Rob Bart, M.D., UPMC chief medical officer, in a statement. “Health systems are now focused on building the governance structures, testing capabilities and organizational strategies necessary to ensure AI delivers meaningful and measurable value.”
    • “The “Validation and Trust: The Governance of AI Solutions at Health Systems” report drew insights from 27 healthcare leaders, including those from health systems and ambulatory care organizations.” 
  • Healio adds,
    • “Many patients report high comfort with health systems using AI-written portal messages, noting it gets them information quickly and reduces clinician workload.
    • “Their comfort comes with caveats, though. Patients want both clinician oversight and transparency that AI is being used.”

Thursday report

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

Simplicity is a virtue.

From of a Washington, DC

  • The New York Times reports,
    • “The White House’s push to delay a ban on intoxicating hemp products that President Trump signed into law last year has snarled an otherwise straightforward effort to pass legislation that would lock in government funding through the fall before senators leave Washington on a summer recess.
    • “In an unusual display of defiance, a group of Republicans led by Senator Ted Budd of North Carolina was vowing to kill the hemp proposal that Senate leaders had tucked into the spending bill at the request of Mr. Trump.
    • “The measure would postpone the date the ban will go into effect, from November to Dec. 11.”
  • Beckers Hospital Review relates,
    • “Sens. Maggie Hassan, D-N.H., and Roger Marshall, R-Kan., introduced the Stop Superbugs Act on Aug. 4 alongside a Joint Economic Committee-Minority report estimating antimicrobial resistance costs the U.S. healthcare system at least $5.7 billion annually.”
  • Beckers Behavior Health adds,
    • Federal lawmakers have introduced or revived several bills this year [discussed in the article] aimed at expanding access to addiction and mental health treatment, from new Medicare coverage for residential opioid treatment to permanent funding for community behavioral health clinics.
  • The current president of the Infectious Diseases Society of America, Ronald Nahass, suggests in STAT News that “The U.S. needs a 9/11 Commission-style independent body to investigate Covid response.” The FEHBlog heartily agrees.
  • Beckers Payer Issues tells us,
    • “This fall, CMS will start sharing monthly utilization reports with Part D plans on how their enrollees are using the Medicare GLP-1 Bridge program.
    • “The agency said in an Aug. 5 memo that the reports will be organized at both the contract and plan level and will include claims-level data such as the date of service, drug dispensed, quantity, days supply, prescriber, fill number and beneficiary identifier. All Part D plans will be covered, except for PACE organizations, cost plans and private fee-for-service plans.
    • “CMS uses a central processor to handle prior authorization, claims adjudication and pharmacy reimbursement, meaning Part D sponsors don’t carry risk for GLP-1 drugs furnished through the demonstration. The utilization reports would give insurers a window into how their own members are using the program despite having no direct role in administering it.”
  • The Wall Street Journal adds,
    • “Amazon AMZN .com said patients with Medicare Part D prescription plans now have access to certain GLP-1 weight-loss medications through Amazon Pharmacy.
    • “Oral and injectable versions of Novo Nordisk’s NOVO.B  Wegovy and Eli Lilly’s LLY  Zepbound KwikPen and Foundayo pills will be available and cost $50 a month with free home delivery, Amazon said. It’s offering same-day delivery in more than 3,100 U.S. locations, and no Prime membership is required, the company added.
    • “The medications are available through the Medicare GLP-1 Bridge Program, a short-term federal initiative running through Dec. 31, 2027, that allows eligible Medicare Part D members who meet specific clinical criteria to access weight management prescriptions.” * * *
    • “Amazon Pharmacy manages the entire process, including verifying eligibility, handling prior authorizations, and initiating enrollment, once a clinician submits an electronic GLP-1 prescription, the company said. Customers need to link their Medicare information and Bridge insuranceplan to their account.
    • “Once a patient’s clinician sends the prescription, we take care of the rest and deliver their medication to their door,” said Tanvi Patel, vice president and general manager of Amazon Pharmacy.”

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

  • Govexec reports,
    • “President Trump is expected sometime this month to issue a plan to freeze federal employee pay in 2027, though if last year was any indication, it may not be that straightforward.
    • “When the White House published its fiscal 2027 budget proposal in April, the document, which normally lays out the administration’s pay plan for the following year, was silent on civilian compensation. The Office of Management and Budget later confirmed that Trump was in fact proposing “no pay increase” for 2027, while military service members would see between a 5% and 7% raise, depending upon their rank.
    • “Trump now has until the end of August to formalize his alternative pay plan for next year; otherwise, much larger automatic increases in locality pay would take effect, due to a formula in the 1990 Federal Pay Comparability Act that has been criticized by presidents of both parties since its enactment.”
  • Federal News Network explains how “OPM is preparing to take over federal employee appeals” as the FEHBlog has noted.
    • “OPM outlined significant changes in the new appeal adjudication process, including the loss of federal employees’ “categorical right” to a hearing.” 
  • Fed Agent informs us,
    • “Federal employees who file claims for back pay, unpaid overtime, unused leave, and other compensation issues will soon be required to submit them through the Office of Personnel Management’s (OPM) eFile system rather than by mail or email. 
    • “The changes could be especially relevant for law enforcement officers and other federal employees who file Fair Labor Standards Act (FLSA) overtime claims.
    • “In an updated rule for Procedures on Settling Claims, OPM said switching to an eFile system “will be used for all appeals and claims to allow for faster receipt facilitating OPM’s processing and review.”
    • “The new system will apply to a wide range of submissions, including claims filed by current and former federal employees, as well as claims submitted by beneficiaries of deceased federal employees and deceased veterans.”

From the FDA front,

  • The Wall Street Journal reports,
    • “Replimune Group said Thursday that the Food and Drug Administration has approved its therapy for advanced skin cancer, ending a regulatory saga that spanned three submissions and two rejections and was a flashpoint in the tenure of the agency’s last commissioner.
    • “Replimune’s drug, marketed as Tudriqev, is a genetically modified virus that doctors inject directly into tumors, where it is designed to kill cancer cells and trigger an immune response against tumors elsewhere in the body.
    • “The drug’s arduous journey through the FDA made it a poster child for the biotech industry’s criticism of the agency under former Commissioner Marty Makary. Replimune and other industry officials said the FDA, in its rejections, had reversed positions it had established in earlier meetings with the company.”
  • Targeted Oncology relates,
    • “The FDA granted accelerated approval to RP1 (vusolimogene oderparepvec; Tudriqev), an oncolytic virus therapy, in combination with nivolumab (Opdivo), for the treatment of advanced melanoma following progression on an anti–PD-1–containing regimen.
    • “The decision follows a July 30, 2026, meeting of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), which voted 10-3 in favor of the potential accelerated approval based on data from the phase 2 IGNYTE trial (NCT03767348). Despite the FDA raising concerns over the study design and clinical meaningfulness of the trial data, the committee supported the accelerated approval because of the unmet need in this setting, with the confirmatory IGNYTE-3 trial (NCT06264180) already underway to support regular approval.”

No Surprises Act News,

  • FHAS, a certifed independent dispute resolution entity, offers helpful guidance about implementing the NSA RARC codes in out-of-network electronic and paper claims.

From the judicial front,

  • Beckers Physician Leadership reports,
    • “A physician in Texas was sentenced to 12.5 years in prison for operating a medical clinic as an illegal pill mill. 
    • “Maryam Qayum, MD, owned, operated and was the sole prescriber at Recare Health Clinic in Houston. The clinic was operated as a cash-only pill mill, and Dr. Qayum issued prescriptions without a legitimate medical purpose, according to an Aug. 5 news release from the Justice Department. 
    • ‘Between 2022 and 2025, Dr. Qayum issued more than 3 million prescriptions for opioids including oxycodone and hydrocodone. Law enforcement shut down the clinic in 2025.”
  • Beckers Health IT relates,
    • “Health systems, insurers and AI companies are facing a wave of litigation in 2026 over how artificial intelligence is used to make or influence decisions about patient care, coverage and billing.”
    • The article discusses three such cases. 

From the public health and medical / Rx research front,

  • Health Exec identifies “Current and potential outbreaks to be aware of—and ready to talk about.”
  • Cardiology Business adds,
    • “The American College of Cardiology (ACC) has shared a new concise clinical guidance (CCG) detailing specific vaccine recommendations for adults and children with a history of cardiovascular disease (CVD).[1] The group reviewed its own evidence-based guidelines as well as updated resources developed by the American College of Physicians and U.S. Centers for Disease Control and Prevention. 
    • “Patients with heart disease face a higher risk of adverse outcomes, including hospitalization and death, following respiratory virus infection compared with the general population,” wrote first author Paul A. Heidenreich, MD, a cardiologist with Stanford University and chair of the CCG’s writing committee, and colleagues. “Additionally, the likelihood of infection after exposure may be elevated in this population.”
    • “Heidenreich et al. also emphasized that both randomized clinical trials and observational studies have consistently demonstrated the advantages of vaccination. Adverse side effects, the group added, are “exceedingly rare and are far outweighed by the demonstrated benefits.”  
  • MedPage Today notes,
    • “The U.S. Preventive Services Task Force recommends annual fecal immunochemical test screening starting at age 45 among average-risk adults to reduce the risk of death from colorectal cancer.
    • “In a retrospective population-based cohort study from Spain, fecal immunochemical test-based screening was linked to an ongoing decline in colorectal cancer mortality.
    • “Counterfactual analyses suggested a 41.7% relative reduction in mortality overall, a 46.2% relative reduction in those ages 50 to 69, and a 45.4% relative reduction in those ages 70 and older compared with projected trends without screening.”
  • The American Medical Association lets us know what doctors want their patients to know about hand, foot, and mouth disease.
  • The Washington Post reports,
    • “Hundreds of people in 27 states have been sickened in a salmonella outbreak linked to jalapeño peppers, including at Chipotle and Qdoba restaurants, the Centers for Disease Control and Prevention said.
    • “As of Tuesday, 345 cases had been reported with 36 people hospitalized, the agency said Wednesday. The cases, which date back to June 19, are expected to rise and expand to more states. 
    • “Twenty-seven “illness clusters” have been identified at Chipotle and Qdoba locations in seven states, the agency said, after health officials found that most of those who got sick reported eating in a Mexican-style restaurant. * * *
    • Neither restaurant is considered an ongoing risk, the CDC said. The distributor is recalling the affected peppers, and other businesses are being urged to check their stocks for recalled jalapeños and not sell or serve them, it said.
    • Salmonella bacteria, the most frequently reported cause of foodborne illness, can cause diarrhea, vomiting, fever and stomach pain.
  • Beckers Hospital Review relates,
    • “The CDC is tracking clinical cases of Candida auris in more than half of U.S. states this year, though the total number of infections from the deadly fungus is down from this time in 2025.
    • “The agency has recorded 3,302 clinical cases of Candida auris across 27 states through the week ending July 18, according to National Notifiable Diseases Surveillance System data. That’s down from 4,102 clinical cases reported over the same period in 2025.
    • “A separate CDC screening count, which tracks colonization detected before any illness develops, logged 3,130 cases across 23 states over the same period, essentially flat compared with 3,348 a year earlier.
    • ‘California leads all states in clinical cases with 826, followed by Texas with 391 and Ohio and Tennessee tied at 274 each. The screening count tells a different geographic story: Texas leads with 706 screening cases, followed by Michigan (503) and Illinois (366).”
  • Beckers Clinical Leadership adds,
    • “The Virginia Department of Health said Aug. 4 it has identified the state’s first locally acquired case of dengue.
    • “The patient lives in the Fairfax and Loudoun county area and had not traveled outside Virginia before falling ill.
    • “State officials traced the infection to an earlier traveler who had contracted dengue abroad. A local Aedes mosquito bit that infectious patient, then transmitted the virus to the second resident. The health department said it has found no evidence of continued local spread.
    • “The department called the overall risk of acquiring dengue in Virginia low.”
  • MedPage Today tells us,
    • “Anxiety and depression have been extensively studied in patients with inflammatory bowel disease (IBD), but research has rarely investigated the pre-diagnostic period.
    • “In a Swedish cohort study, the relative rate of any psychiatric disorder started to increase 2-3 years before IBD diagnosis, peaked soon after diagnosis, and rapidly decreased post diagnosis, but remained elevated at 10 years.
    • “This increased risk was mainly driven by major depressive disorders, anxiety disorders, and substance misuse.”
  • STAT News informs us,
    • “In the race for new ways to treat Alzheimer’s and other devastating neurologic diseases, the protein tau has become a tantalizing target for drug developers. A new study lends support to those efforts by describing a previously unknown role that tau plays in neurodegeneration — and suggesting a novel way researchers might block the protein’s activity.
    • “A team led by Stanford scientists found that tau can gum up the works of a cell’s mitochondria, its energy-producing powerhouse. The protein sends electrons flowing in the opposite direction of their usual microscopic relay race, a reversal that generates reactive oxygen species, cellular stress, and inflammation. Scientists found that blocking this phenomenon, known as reverse electron transport, reversed many of the harmful effects and improved learning and memory in flies and mice.
    • “Whether the same will hold true in people is for now unclear, though an analysis of human cells grown in the lab and patient brain tissue suggests blocking the retrograde flow of electrons could make neurons healthier. Two of the study’s authors have started a biotech startup to put this idea to the test. 
    • “The findings, published on Thursday in the journal Neuron, have implications for a range of so-called tauopathies, diseases marked by an abnormal buildup of tau, such as Alzheimer’s, Huntington’s, and frontotemporal dementia.”
  • Genetic Engineering and Biotechnology News points out,
    • Chronically infecting viruses—such as Epstein Barr, cytomegalovirus, and herpes virus—are ubiquitous in humans. Although their presence is often innocuous and asymptomatic, the viruses can reactivate during stress, and emerging evidence suggests that their reactivation may contribute to autoimmune disease and other chronic conditions. SARS-CoV-2 infection is known to reactivate some chronic viruses, yet the full extent of the effects is not well understood.
    • Now, a study including 15 biomedical research institutions across the United States, Boston Children’s Hospital researchers and their collaborators have discovered that COVID-19 reactivates certain dormant viruses in hospitalized patients. These findings expand understanding of chronically infecting viruses and could inform development of strategies to combat their reactivation.
    • “This work is published in a new study in Nature, entitled, “Virus reactivation in acute and long COVID-19.”
  • The New York Times notes,
    • “Novo Nordisk stunned the cardiology world last week when it announced that a large study it was running on an experimental drug for heart disease had failed. The drug, widely expected to be a blockbuster, was no better than a placebo.
    • “The drug, ziltivekimab, reduces inflammation, which is generally thought to be a cause of atherosclerosis. Stopping that inflammation was hoped to be a way to save lives.
    • “Now the drug’s failure is raising a troubling question. Is inflammation really a cause or is it just a marker of atherosclerosis, the way gray hair is a marker of aging?
    • “Cardiologists had mixed reactions to the news. Dr. Sanjay Kaul, a cardiologist at Cedars Sinai, quoted Thomas Huxley on X: “The great tragedy of science — the slaying of a beautiful hypothesis by an ugly fact.”

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

  • Health Exec points out,
    • “The latest lineup of America’s “best of the best” hospitals from US News & World Report is something of an embarrassment of riches for a few cities and health systems. 
    • “The list—which ranked hospitals numerically until 2023 but now presents 20 institutions alphabetically as an “honor roll”—names one health system three times.
    • “That would be Mayo Clinic, recognized for each of its operations in Rochester, Minn., Phoenix, Ariz., and Jacksonville, Fla. 
    • “Meanwhile New York City is home to three winning institutions—Mount Sinai, NewYork-Presbyterian and NYU Langone. 
    • “A few cities have two hospitals in the roll. These are Boston (Brigham and Women’s, Massachusetts General), Chicago (Northwestern, Rush) and Los Angeles (Cedars-Sinai, UCLA Ronald Reagan).
    • “The state with the most honorees is California, which has bragging rights to five—the two L.A. hospitals named above plus Stanford Health Care in Palo Alto, UC San-Diego Health in that city and UCSF Health in San Francisco.”
  • Beckers Hospital Review adds,
    • “The Emergency Nurses Association awarded a record-breaking 126 emergency departments with the 2026 Lantern Award.
    • “To receive a Lantern Award, EDs must submit a comprehensive application which measures how they excel in meeting challenges, including ED boarding, improving pediatric readiness and enhancing nurse professional development, according to a July 27 news release. ENA Lantern Award Committee reviews and scores applications based on evidence-based practices and innovation in emergency care. Learn more here. The Lantern Awards have been awarded annually since 2011.
    • “Last year, 96 hospitals received a Lantern Award.”
    • The article lists the 2026 awardees by State.
  • Beckers Hospital Review outlines the 23 hospital M&A transactions that have happened this year.
  • Beckers Payer Issues calls attention to “the thread running through payers’ and for-profit [health] systems’ Q2 earnings,” and tells us,
    • “Oscar Health’s membership as of June 30 was 2,963,002, up from 2,027,148 at the same time in 2025.
    • “The company reported net income of $361.8 million for the second quarter of 2026, up from a $228.4 million loss during the same period last year. Revenue was roughly $4.9 billion, up 70.4% year over year. Earnings from operations were $388.6 million versus a prior $230.5 million loss, driven by stronger underwriting performance, along with favorable prior period development.
    • “The insurer logged a medical loss ratio of 79.2% for the quarter, down from 91.1%. 
    • ‘The full-year 2026 outlook for earnings from operations is now $500 million to $700 million, a boost from $250 million to $450 million previously.”
  • BioPharma Dive reports,
    • “LifeMine Therapeutics, a biotechnology company led by serial entrepreneur Greg Verdine, said Thursday it raised $263 million in a pair of venture financings that will push a novel, protective treatment for organ transplants deeper into later clinical testing.
    • “To find that new drug, codenamed “LIFE-001,” LifeMine looked to a billion-year-old place: the fungal genome. It’s the same starting point that led to the first statin, penicillin, and a widely used immunosuppressant called cyclosporine. While these and many other medicines are derived from fungi, LifeMine has for years been working to make the discovery process more systematic and repeatable, amassing a database of genomic information in the hopes of uncovering promising drug prospects. 
  • MedTech Dive interviews “Medtronic’s George Murgatroyd [about] an advanced computing platform that works with the company’s Hugo robot will power AI algorithms that can assist surgeons as they operate.”

  • Beckers Physician Leadership notes,
    • “Aflac’s fourth annual Wellness Matters Survey found 76% of Gen Z and 63% of millennials now turn to artificial intelligence as their first line of primary healthcare, according to results released Aug. 4.
    • “The survey, conducted in March 2026 by Kantar Profiles among 2,000 employed U.S. adults ages 18 to 65, found AI use for healthcare drops sharply with age: 47% of all Americans surveyed use AI for health information, compared to 76% of Gen Z and 63% of millennials.
    • “The shift toward AI comes as younger workers skip in-person care. Sixty-five percent of Gen Z and 61% of millennials reported skipping routine checkups in the past year, compared to 47% of Gen X and 33% of baby boomers. Only 48% of Gen Z respondents have a primary care doctor, versus 87% of baby boomers.
    • “Emergency and urgent care use also rose among Gen Z, climbing to 62% in 2026 from 51% in 2025. Usage increased among Hispanic, Black, and Asian American respondents as well.
    • “Matthew Owenby, Aflac’s chief human resources officer and chief administrative officer, said younger Americans are substituting convenience for consistent care. “Young Americans are replacing in-person preventive care with the convenience and speed of digital health support,” Mr. Owenby said.”

Tuesday report

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

From Washington, DC,

  • Punchbowl News reports,
    • “The Senate’s ability to clear its pile-up of legislation and nominations before a five-week summer recess may come down to two GOP decisions: whether to attempt to pass a budget resolution and whether to force a crypto vote that could fail.
    • “A short-term government funding bill cleared its first procedural hurdle Monday night, with 89 votes — a major boost for the bipartisan push to fast-track it. That followed 86 votes for a landmark Russia sanctions bill last week.
    • “Neither bill can pass before the scheduled August recess without consent from all 100 senators. That gives Democrats leverage, and they’re using it against two Republican priorities.”
  • Beckers Behavioral Health relates,
    • “The Centers for Medicare & Medicaid Services released a toolkit to help state Medicaid and Children’s Health Insurance Program agencies strengthen oversight of applied behavior analysis (ABA) services for children with autism, according to an Aug. 4 news release from the federal agency. 
    • :This toolkit comes as Medicaid spending on autism therapy has surged in several states in recent years. In Colorado, Medicaid spent more on autism therapy for children last year than on emergency room care for all patients, according to a recent investigation by The New York Times. The investigation also found some clinics prescribe 25 or even 40 hours of therapy each week for young children. Average daily appointments also have increased over time, according to Medicaid data analyzed by Trilliant Health.” * * *
    • “CMS said the resource is designed to help states ensure ABA services are medically necessary, individualized and evidence-based while identifying fraud, waste and abuse. The agency said it does not establish new federal requirements, reduce Early and Periodic Screening, Diagnostic, and Treatment obligations, endorse a single ABA treatment approach or limit access to medically necessary care.”
  • The ABA toolkit is available at: https://www.medicaid.gov/medicaid/downloads/autism-services-aba-toolkit.pdf 
  • Beckers Clinical Leadership notes,
    • “CMS will require hospitals to report performance on a patient malnutrition measure starting in 2028 under the Hospital Inpatient Quality Reporting Program.
    • The agency finalized the measure as part of its fiscal year 2027 Inpatient Prospective Payment System final rule released July 31.
  • Beckers Payer Issues points out,
    • “ACA insurers are pitching a median rate increase of 15% for 2027, the second year in a row of double-digit premium hikes, according to a July 8 Peterson-KFF Health System Tracker analysis that was updated Aug. 3.
    • “The tracker reviewed 276 insurers in marketplaces across the country with publicly filed rates. The tracker’s analysis considered an insurer’s premium increase as the enrollment-weighted average rate change across its offerings in a state. While rates will be finalized in late summer, these filings provide a glimpse of the year ahead.” * * *
    • “For 2026, the median nationwide proposed rate change was 18%. The median finalized rate change was 20%.”

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

  • Govexec reports,
    • “Most funds offered as part of the federal government’s 401(k)-style retirement savings program finished July in the red, continuing the downward trend that began the prior month.
    • “Only the Thrift Savings Plan’s G Fund, which is made up of government securities, grew last month, increasing by its statutorily mandated rate of 0.39%. So far this year, the G Fund has gained 2.57% in value.
    • “The common stocks of the C Fund were virtually flat in July, falling 0.07% and bringing its 2026 performance down to 10.13%. And the international (I) fund lost 1.01% last month; since January, the I Fund is up 15.35%.
    • “The small- and mid-size businesses of the S Fund finished July 4.12% in the red. So far this year, the S Fund has gained 13.52%. And the fixed income (F) Fund lost 1.29% last month, bringing its 2026 losses to 0.56%.
    • “Each of the TSP’s lifecycle (L) funds, which shift toward more conservative investments as participants approach retirement age, likewise lost ground in July.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the electronic Official Personnel Folder (eOPF) Document Request Service (DRS), a secure online portal that enables eligible former federal employees to request and receive copies of their official personnel records electronically — eliminating a manual process that previously often required paper forms, agency requests, or a request to the National Personnel Records Center.”
    • * * * “Users access the Document Request Service through Login.gov, complete a one-time identity verification, and submit a brief online request. Once processed, they receive a secure email containing a time-limited download link to a password-protected ZIP file with their complete eOPF Employment Folder.
    • “The DRS is available to separated federal employees whose records are maintained in eOPF, as well as current federal employees whose agencies do not provide government-furnished equipment to access their own personnel records. Current employees with access to the eOPF application should continue to retrieve their records directly through that system.
    • “The launch of the Document Request Service is part of OPM’s broader effort to modernize federal human resources systems, improve customer service, and reduce reliance on manual, paper-based processes across the federal government. Additional information, including a user guide, is available at Documents Request Service – eOPF Resource Center.”
  • FEHBlog Observation — OPM continually is improving IT services for which the agency deserves credit. The efforts make it more puzzling why OPM has not yet implemented the HIPAA 820 Standard Enrollment Roster Transaction in the FEHB, PSHB, and FEDVIP programs.
  • Noah Peters, an OPM Senior Adviser has added a post to the Secrets of OPM blog titled (OPM.gov link) “Restoring Merit With the Right Civil Service Exam.”

From the Food and Drug Administration front,

  • QualityAssuranceMag reports,
    • “A multistate outbreak of E. coli O145:H28 infections has been linked to organic frozen blueberries from Frutas y Hortalizas del Sur S.A., of San Carlos, Chile, sold under the GreenWise brand at Publix.
    • “The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), along with state and local partners, are investigating the outbreak, which has sickened 12 and hospitalized four in two states, Florida and Georgia.
    • “Publix recalled all lots of GreenWise Organic Frozen Whole Blueberries and Whole Mixed Berries due to potential E. coli contamination. Recalled product was shipped to Publix retail stores in eight states: Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee and Virginia.” 
  • MedTech Dive relates,
    • “Caristo Diagnostics has received de novo authorization for an AI tool that quantifies coronary inflammation from routine imaging scans, the company said last week.
    • “The Food and Drug Administration authorization covers a device, CaRi-Heart, that uses coronary computed tomography angiography to estimate a patient’s risk of cardiovascular mortality over 10 years.
    • “Research suggests the tool could help physicians stratify risk among patients who present with chest pain but are free from obstructive coronary artery disease.”
  • and
    • “DeepHealth last week received the Food and Drug Administration’s 510(k) clearance for an artificial intelligence tool that reads breast ultrasound images and generates reports.
    • “The feature can help clinicians localize suspicious soft tissue lesions; characterize details about the lesion such as its shape, orientation, and margin; and generate a report with key findings and impressions. Radiologists still have control of the final assessment. 
    • “DeepHealth’s parent company, RadNet, plans to offer the tool across its network of imaging centers by the end of the year.”
  • Targeted Oncology tells us,
    • “FDA authorized a new rituximab biosimilar based on comprehensive comparability data demonstrating high similarity to reference rituximab and no clinically meaningful clinical differences. 
    • “Market expansion of CD20 biosimilars may increase competitive pressure, shaping formulary positioning, contracting, and purchasing decisions that weigh price against continuity of supply. 
    • “Rituximab remains foundational across B-cell malignancies and autoimmune indications, reflecting its CD20-binding mechanism and B-cell depletion via multiple immune effector pathways. 
    • “Class safety considerations persist, including boxed warnings for fatal infusion reactions, severe mucocutaneous reactions, HBV reactivation, and PML, alongside risks of serious infections.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has announced that Ascend Laboratories is recalling specific lots of dabigatran etexilate, a blood thinner taken to reduce the risk of stroke or blood clots in patients with nonvalvular atrial fibrillation. This is a generic version of a popular direct oral anticoagulant (DOAC) most commonly sold by Boehringer Ingelheim under the brand name Pradaxa. 
    • “The recall was put in place due to a failed impurity/degradation test. After 12 months, the drug produced an out-of-specification (OOS) test result.“
    • “The FDA is still investigating this issue. Click here for additional details from the agency.”
  • The American Hospital Association News points out.
    • “The Food and Drug Administration Aug. 3 identified Class I recalls of two convenience kit products. Certain kits by Medline Industries have been recalled due to the containment of recalled Huons Bupivacaine Hydrochloride Dextrose Injections. The injections pose a risk of infection, inflammatory response and/or reduced anesthetic effectiveness. Certain convenience kits by Medical Action Industries have also been recalled due to the containment of Medline’s Namic Angiographic Star Off Handle Manifolds, which have been found to contain particulate within the fluid path of the manifolds.
    • “In addition, the FDA issued an early alert for certain Intraosseous Vascular Access System Needle Sets by Becton Dickinson due to some lots being manufactured with out-of-tolerance dimensions. BD said it has resulted in some lots being manufactured with out-of-tolerance dimensions, with some users reporting difficulty removing the obturator following placement of the needle sets.” 

From the public health and medical/Rx research front,

  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention is expanding the largest known cyclosporiasis outbreak to 15 states, adding six states where illnesses have been traced to shredded iceberg lettuce sourced from central Mexico, according to three individuals familiar with the investigation.
    • “Missouri, which is reporting 1,095 cases, is one of the states being added, according to a state health department spokesperson. The number of state cases jumped dramatically in the past week. Patients who were interviewed at length by state and local investigators said they consumed Taco Bell before getting sick, spokesperson Lisa Cox said.
    • “The other states are Arkansas, Iowa, Nebraska, New Hampshire and North Carolina, according to a fourth person familiar with the investigation.”
  • The New York Times considers,
    • “Is It OK to Eat the Same Things Every Day?
    • “Some people do it to lose weight, others to avoid the hassle of planning meals. We asked experts how “food monotony” affects your health.”
  • Beckers Hospital Review relates,
    • “In 2025, New Mexico confirmed 100 measles cases across nine of its 33 counties, and each case cost an average $53,522, according to research published Aug. 4 in Annals of Internal Medicine. 
    • “Researchers with the CDC and New Mexico Department of Health analyzed the societal economic burden of these 100 cases through public health response costs, direct medical costs and productivity losses. The public health response costs totaled about $3.2 million, including $2.1 million for vaccination-related activities. About 130 public health responders worked on contact tracing across 205 contacts, which each cost $1,817, according to the study. 
    • “The $53,522 per measles case, equal to $5.35 million in total, ranged from February through September 2025.”
  • MedPage Today tells us,
    • “A peptide vaccine targeting KRAS mutations in patients at high risk for pancreatic cancer induced durable T-cell responses.
    • “In 16 patients with evaluable pancreatic cysts, three had complete resolution of the cysts, three had partial regression, and the rest had stable cyst status.
    • “No patient developed severe vaccine-related adverse events.”
  • and
    • “In a randomized trial, a novel system for autonomous control of supplemental oxygen for inpatients who needed it improved the proportion of time spent with adequate oxygen levels.
    • “The study showed safety of the approach and lower oxygen use overall compared with usual care.
    • “The trial could not assess clinical outcome effects like reduced respiratory decompensation, shorter hospital stays, or improved survival.”
  • Health Day points out,
    • “Women who enter menopause at an earlier age have an increased risk of high blood pressure, a new study says.
    • “Researchers found that nearly 23% of women with premature menopause and 19% of women with early menopause had high blood pressure, compared to under 17% of women with normal menopause, researchers found.
    • “Overall, premature menopause brought a 12% higher risk of high blood pressure compared to women who reached menopause after age 45, researchers reported recently in the journal Menopause.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Recurrent urinary tract infections (rUTIs) are among the most common bacterial infections worldwide. The difficult-to-treat condition, which affects primarily women, is defined as two urinary tract infections (UTIs) within six months or three UTIs within the past year. They are a leading cause of outpatient antibiotic use, accounting for more than 15% of all prescriptions.
    • “While antibiotics remain the standard treatment, frequent recurrences and rising antibiotic resistance highlight the need for alternative therapeutic approaches. Now, researchers have, for the first time, administered a combined phage therapy (PT) with fecal microbiota transplantation (FMT), to decolonize urinary and intestinal reservoirs of rUTI patients.
    • “The novel treatment approach, combining PT and elective FMT, was administered to three female patients, between May and July 2023, with rUTI that did not respond to antibiotics and commonly used non-antibiotic strategies. All had microbiologically confirmed E. coli in multiple infections.
    • “All three women received PT orally and intravesically (locally applied to the bladder via catheter) for eight days outside of acute episodes. Two of these three patients were elected to receive subsequent FMT. Since the bacteria causing the recurring infections often reside in the gut as well as the urinary tract, the FMT treatment targeted the intestinal reservoirs of E. coli that survive antibiotic treatment of acute infections and can become increasingly resistant.
    • “While phage therapy acts to remove the pathogen, FMT aims to restore a healthy microbiome, combining both immediate and long-term effects,” Lena Biehl, MD, PhD, group leader at Fraunhofer ITMP, deputy lead of Cologne Microbiota Bank, University Hospital Cologne.
    • “This work is published in Nature Microbiology in the paper, “Combined Phage therapy and fecal microbiota transplantation to treat recurrent urinary tract infection: a case series.”
  • Per Fierce Pharma,
    • “In a milestone for IgA nephropathy, Otsuka’s Voyxact has shown for the first time in a phase 3 trial that a drug can stabilize patients’ kidney function decline to the normal rate seen in healthy adults. 
    • “Results from the phase 3 Visionary trial showed that Voyxact (sibeprenlimab) achieved an annualized estimated glomerular filtration rate (eGFR) slope of a 0.3 mL/min/1.73m² gain over two years, suggesting an improvement in kidney function. The rate matches the normal age-related decline of less than 1 mL/min/1.73m² per year, as laid out in the KDIGO 2025 Clinical Practice Guideline for IgAN.
    • “To be presented at the GlomCon Hawaii 2026 conference, the latest Voyxact result is better than an annualized eGFR slope of negative 4.2 mL/min/1.73m² for placebo. It’s also better than Voyxact’s own performance over 12 months, when it recorded an annualized loss of 3 mL/min/1.73m² at an interim analysis of the Visionary trial.”
  • and
    • After a yearslong struggle, Jazz Pharmaceuticals has called time on Zepzelca as a second-line treatment for small cell lung cancer.
    • In alignment with the FDA, Jazz plans to ask the agency to remove the second-line SCLC indication from Zepzelca’s label, the company said Monday alongside its second-quarter earnings report.
    • The decision comes after the confirmatory phase 3 Lagoon trial recently failed on its primary endpoint of overall survival. In the study, Zepzelca (lurbinectedin) monotherapy performed even worse than other chemotherapy regimens, while a combination of Zepzelca and irinotecan showed a numerical advantage that didn’t meet statistical significance.

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

  • Beckers Payer Issues tells us,
    • “Louisiana workers pay the largest share of their income toward their portion of health insurance premiums, while workers in Hawaii pay the smallest, according to an AHIP analysis of Commonwealth Fund data published in July.”
    • The article lists all of the States’ percentages. 
  • and
    • “UnitedHealthcare is rolling out new reimbursement limits on five categories of lab tests across its commercial, ACA, Medicare Advantage and Medicaid plans.
    • “The five policies cover allergen testing, liver fibrosis testing, in vitro chemotherapy sensitivity assays, testosterone blood tests and vitamin B12 testing. 
    • “The policies generally take effect Sept. 1 for commercial, exchange and MA plans, though several states have an effective date of Oct. 1 in the commercial and exchange markets. The Medicaid rollout is staggered by state, with effective dates ranging from August through November.
    • “Broadly, the policies set frequency caps or exclude specific test types from reimbursement.”
  • Fierce Healthcare informs us
    • “AI health tech company Daffodil Health is rolling out a new platform aimed at supporting payers in managing the No Surprises Act dispute process.
    • “The number of cases reaching the NSA’s independent dispute resolution process continues to grow. For example, when the process was established by regulators, they projected about 17,000 cases would make it to IDR each year—however, 1.2 million were filed in just the first half of 2025.
    • “Daffodil’s tool is built to support insurers and third-party administrators in handling that volume of disputes, starting with intake and through negotiation, arbitration and reporting, the company said in an announcement.”
  • Beckers ACS Review lets us know,
    • “Austin, Texas-based Ouma Health has acquired a multisite maternal-fetal medicine practice led by Tamara Takoudes, MD, expanding the telemedicine company’s footprint across Connecticut, Massachusetts, Maine and New Hampshire, according to an Aug. 4 news release.
    • “The acquisition adds established in-person clinical locations to Ouma’s national teleMFM network and strengthens the company’s relationships with hospitals, imaging centers, birth centers and community obstetric practices across New England. 
    • “Ouma, which describes itself as the nation’s largest independent maternity telemedicine company, said the deal is part of a broader effort to build clinical infrastructure for high-risk pregnancy care as MFM workforce shortages and hospital labor and delivery unit closures continue to limit access in many communities. Financial terms were not disclosed.”
  • Beckers Behavioral Health adds,
    • “San Francisco-based Amae Health, a provider of mental healthcare, is collaborating with Google Health Enterprise to bring wearable-derived data into its precision psychiatry care model.
    • “The collaboration will allow Amae Health’s care teams to incorporate data from wearable devices — including sleep patterns, physical activity, heart rate variability and changes in daily routines — alongside existing clinical information, according to an Aug. 4 news release. The company said the additional data is intended to help clinicians detect changes in patients’ conditions earlier and better identify potential relapses among people with schizophrenia, bipolar disorder and major depressive disorder.”
  • Per a Lown Institute news release,
    • “U.S. hospitals can excel at both clinical care and making critical investments in the people and communities they serve. That is the key takeaway of the 2026 Lown Hospitals Index ‘Honor Roll’, which recognizes 123 institutions that achieved top ratings on health equity, value of care, and patient outcomes.
    • “With financial pressures forcing painful choices on many hospitals, those on the Lown Honor Roll have found ways to put their patients and communities first,” said Vikas Saini, MD, president of the Lown Institute. “These hospitals are staying true to their mission when it matters most, and in healthcare, that’s everything.”
  • Per Beckers Hospital Review,
    • U.S. News & World Report released its 2026-27 Best Hospitals rankings and ratings Aug. 4, which included a list of 505 Best Regional Hospitals across 49 states and the District of Columbia.
    • The latest edition of Best Hospitals, now in its 37th year, evaluated hospitals on measures such as risk-adjusted mortality rates, preventable complications and patient experience. This year’s rankings placed significantly greater weight on risk-adjusted patient outcome measures in determining results. For the first time, Maternity Care recognition was also incorporated into Best Regional Hospitals point calculations. More information about the methodology is available here and here.
  • Healthcare Dive adds,
    • “New Jersey health system Hackensack Meridian Health has become the first organization to earn the Joint Commission’s seal of approval for the responsible use of artificial intelligence in healthcare.
    • “The Joint Commission, an independent accreditation organization, launched the certification in June with the goal of endorsing U.S. healthcare organizations able to demonstrate they have the proper governance, resources, policies and training programs for the safe and effective use of AI.
    • “HMH has been refining its AI systems for years, according to Dr. Lauren Koniaris, the organization’s chief medical informatics officer. “As we expand our clinical AI initiatives, we operate under the utmost governance to ensure patient quality and safety are always the priority,” she said”
  • Per the Wall Street Journal,
    • “Pfizer reported second-quarter revenue of $15.03 billion, up 3% and beating analyst expectations as non-Covid drug sales grew.
    • “Pfizer recorded a second-quarter loss of $248 million, driven by a $3.8 billion write-down on an experimental lung-cancer drug.
    • “Pfizer raised the low end of its full-year sales guidance to a range of $60.5 billion to $62.5 billion.”
  • and
    • “Amgen AMGN  lifted its outlook for the year after strong drug sales bolstered the company’s bottom line in the second quarter, but added that it would end development of an early-stage obesity treatment.
    • “The biotechnology company on Tuesday said it was halting the development of AMG 513, a potential obesity treatment currently in a phase 1 study. That study will be carried to completion to follow enrolled participants, Amgen said. The company didn’t provide a reason for the discontinuation.
    • “With development of AMG 513 ending, Amgen’s only candidate in the space is MariTide, which is currently in phase 3 studies for a range of indications such as obesity, Type 2 diabetes and chronic weight management.
    • “Amgen also lifted its guidance, saying it now expects full-year revenue between $38.2 billion and $39.4 billion, up from a previous view of $37.1 billion to $38.5 billion. Adjusted per-share earnings are expected between $22.30 and $23.50, up from a range of $21.70 to $23.10.”
  • and
    • “Gilead Sciences reported second-quarter revenue rose to $7.8 billion, but swung to a $10.5 billion loss due to acquired research expenses.
    • “Gilead Sciences’ revenue growth was driven by a 12% rise in HIV product sales to $5.69 billion, while sales of Covid-19 drug Veklury fell 81%.
    • “Gilead Sciences narrowed its full-year product-sales guidance to a range of $30.1 billion to $30.4 billion.”
  • and
    • “Novo Nordisk said annual sales and operating profit should fall less than previously expected following a boost in the second quarter.
    • “Novo Nordisk expects adjusted sales and operating profit to decline up to 6% at constant exchange rates this year, compared with its prior forecast of a 4% to 12% decline.
    • “Adjusted sales for Novo Nordisk grew 7% to 78.49 billion Danish kroner in the second quarter, while adjusted operating profit rose 11%.”
  • STAT News adds,
    • “BioNTech on Monday named Guido Oelkers, formerly the leader of the Swedish biopharma company Sobi, as its new CEO, as the Covid-19 vaccine developer continues its shift to oncology.
    • “Oelkers will replace Ugur Sahin as CEO. In March, BioNTech announced that Sahin and his cofounder and wife Özlem Türeci, the company’s chief medical officer, would depart the company to lead a new biotech focused on developing mRNA medicines.
    • “Oelkers, who has worked in biopharma for more than 30 years, will start by Feb. 1, 2027, the company said. He said that he would continue BioNTech’s work to be a global company with multiple approved medicines by 2030.”
  • BioPharma Dive helps us track the patent expiration dates of name brand prescription drugs.