Midweek update

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Electronic health records, FDA, Federal employment benefits, HSA, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC

  • Beckers Hospital Review reports,
    • “The U.S. national debt surpassed $40 trillion for the first time Aug. 19, adding another layer of financial uncertainty for hospitals already navigating elevated borrowing costs and significant federal reimbursement pressures, according to The New York Times. 
    • “The news comes as the federal government is on track to borrow more than $2 trillion this year, with rising interest expenses consuming an increasingly large share of federal spending, according to the report. 
    • “The knock-on effects extend far beyond the federal government’s balance sheet. Higher Treasury yields can increase hospitals’ cost of capital, while the deteriorating fiscal outlook could intensify scrutiny of Medicare, Medicaid and other federal healthcare programs already targeted by the Trump administration for spending reductions.”
  • STAT News relates,
    • “Erica Schwartz, the new director of the Centers for Disease Control and Prevention, told agency staff on Wednesday that she was prepared to disagree with administration leaders and sought to empower others to do the same, according to a recording of the meeting obtained by STAT.
    • “During her first all-hands address on Wednesday, Schwartz identified three priorities: preserving trust through radical transparency and scientific rigor; strengthening the CDC’s ability to respond to disease threats; and building up the agency’s relationship with state and local partners.”
    • “She said she was ready to stand up to health secretary Robert F. Kennedy Jr. if needed to accomplish those goals.
    • :Schwartz said she wasn’t blind to what her predecessor, Susan Monarez, went through — being fired because she wouldn’t agree to follow Kennedy’s orders on vaccine policy — and said she was clear with Kennedy she would act and share information as a physician.
    • “I feel very comfortable and very confident, already having like three or four meetings with them since I started this position, of speaking truth to power,” she said. “I do not feel at all challenged with speaking, you know, what the science tells me and what you all are telling me to represent for the CDC.”
  • Per a CMS news release,
    • “The Trump Administration announced a $90 million investment is being delivered to South Dakota through the federal Rural Health Transformation Program (RHTP) to accelerate digital health modernization, strengthen cybersecurity, and enhance interoperability across rural and underserved communities. This investment will strengthen South Dakota’s health 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.”
  • Beckers Payer Issues tells us,
    • “The average end-of-year balances for health savings accounts reached $5,532 in 2024, up from $4,747 the year prior.
    • “However, that balance fell far below out-of-pocket maximums. In 2025, out-of-pocket maximums for HSA-eligible health plans were $8,300 for individual coverage and $16,600 for families.
    • “The Employee Benefit Research Institute released an issue brief Aug. 13 detailing HSA trends from 2011 through 2024. The institute formed its HSA database more than a decade ago. As of the end of 2024, the database had 15.2 million accounts with total assets of $53.7 billion.
    • “The report outlined the “triple tax advantage” of HSAs: tax-free contributions, tax-free growth and tax-free qualified withdrawals.”
  • Fierce Healthcare points out,
    • “While many individuals believe they have a firm grasp on their Medicare benefits, the reality is far different, according to a new survey.
    • “Insurance agency eHealth conducted a survey of 1,000 Americans and found that 89% of beneficiaries feel “confident” that they understand their Medicare benefits and coverage options. However, just 13% could identify each of the main facets of Medicare, such as the traditional program, Medicare Advantage, Part D and Medicare supplement plans.
    • “In addition, most (88%) said they did not know there is no annual cap on out-of-pocket spending in traditional Medicare, while 82% of those nearing Medicare eligibility said they were not aware that there is a 20% coinsurance for medical services.
    • “Close to half (42%) of beneficiaries were unaware or underestimated that 20% coinsurance, according to the report.”
  • Beckers Behavioral Health informs us,
    • “The percentage of U.S. adults who report doing any kind of gambling during the past year fell to 45%, down from 64% a decade ago, according to an Aug. 17 report from Gallup. 
    • “The findings are based on telephone interviews conducted by ReconMR June 1 to July 19, 2026, with a random sample of 2,201 adults, aged 18 and older, living in all 50 U.S. states and the District of Columbia. Gallup also conducted a web survey from June 1-15, 2026, with a stratified random sample of 2,043 adults, aged 18 and older, who are members of the Gallup Panel.’ 

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

  • FedWeek lets us know,
    • “The [Federal Employee Benefits] open season this year will run November 9-December 14. Available plans and their premiums for the upcoming year typically are announced a month or so in advance, with fuller details released just ahead of the enrollment period.”
  • OPM Director Scott Kupor made his latest post to his Secrets of OPM blog available on LinkedIn today. The post concerns a recent OPM employee survey.

From the Food and Drug Administration front,

  • CBS News reports,
    • “The Food and Drug Administration upgraded a recall of frozen blueberries and mixed berries sold at Publix grocery stores across the U.S. to the highest health risk level on Tuesday, according to an enforcement report.” 
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) to reduce daily cornstarch intake as an adjunct to nutritional management in adults and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa), a rare, inherited genetic disorder caused by a deficiency of the enzyme glucose-6-phosphatase, which prevents the body from properly breaking down stored glycogen into glucose. Genglycos is the first approved treatment for this condition.
    • “The accelerated approval pathway allows the FDA to approve certain drugs or biologics intended to treat a serious or life-threatening disease or condition if the agency determines the treatment has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
    • “Patients with GSDIa face possible life-threatening complications and have limited treatment options that include primarily life-long, strict dietary management,” said Karim Mikhail, B. Pharm., M.S., acting director of the Center for Biologics Evaluation and Research (CBER). “Today’s approval is a great milestone in using a gene therapy to treat this disease and improve the quality of life for people with this condition.”
  • and
    • “The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time, which may help address the current phlebotomist shortage in the U.S.
    • “This authorization reflects the FDA’s commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists.”
  • Fierce Pharma tells us,
    • “After more than 10 years in development, Regeneron secured a landmark approval for its monoclonal antibody garetosmab, now commercially known as Pasatru. The drug has become the second cleared by the FDA to treat fibrodysplasia ossificans progressiva (FOP) and the first to reduce clinician-assessed flare-ups in adults with the disease.
    • “Pasatru, given intravenously every four weeks, is designed to block what is believed to be the key protein behind the FOP disease process—activin A—which was pinpointed by Regeneron scientists as a possible target for treating FOP more than a decade ago. 
    • “The approval follows a victory last year in a phase 3 study, which randomized 63 adults with FOP to receive one of two doses of the anti-activin A antibody or placebo every four weeks for 56 weeks. In the trial, both high- and low-dose Pasatru reduced new bone lesions in FOP patients by 90% over 56 weeks. And high dose Pasatru reduced bouts of painful localized inflammation by 89% compared to placebo, too.
    • “By the end of the trial, an independent data monitoring committee recommended all patients on placebo be switched to Pasatru as soon as possible.” 

No Surprises Act News,

  • Modern Healthcare reports,
    • “Providers are triumphing against insurers in bitter out-of-network billing battles at a record pace and by an unprecedented margin.
    • “President Donald Trump enacted the No Surprises Act in 2020. The law succeeded in protecting patients from many surprise medical bills. But its baseball-style arbitration system was quickly overwhelmed.
    • “Independent Dispute Resolution filings represent a tiny percentage of commercial health insurance claims, but cases have increased each year since the process debuted in 2022. Disputes rose almost 75% to more than 2.5 million from 2024 to 2025, according to an analysis of Centers for Medicare and Medicaid Services data the Niskanen Center published in July. CMS originally projected there would be about 17,000 cases a year.
    • “Providers won 83.6% disputes in the fourth quarter of 2025, a share that’s been consistent since 2023, according to the Niskanen Center, a centrist think tank.
    • “Provider groups maintain these wins are warranted and arbitrators have agreed. Publicly held insurers including UnitedHealth Group subsidiary UnitedHealthcare, CVS Health subsidiary Aetna and Elevance Health contend out-of-network providers are abusing the system. Last month, CMS acknowledged arbitration is not working as intended and suggested it would take action.
    • “When we look at other models of arbitration, the win rates tend to be 50-50, and it tends to be a pretty rare option of last resort,” said Christopher Whaley, a health economist at Brown University. ”Obviously, that’s not happening in the No Surprises Act arena.”
  • FEHBlog observation: The NSA IDR rules stack the deck in favor of the providers who have inside information on the provider’s credentials and the patient’s acuity.

From the judicial front,

  • Fierce Pharma reports,
    • “In their attempts to challenge the Medicare drug price negotiation program, introduced by former President Joe Biden under the Inflation Reduction Act (IRA), biopharma companies have been largely shut out in federal courts.
    • “On Tuesday, however, Teva Pharmaceuticals gained a partial win as the U.S. Court of Appeals for Washington, D.C. sent (PDF) a previous ruling back to the District Court for further review. It concerns Teva’s challenge to the requirement by the Centers for Medicare & Medicaid Services (CMS) that a generic drug be genuinely marketed before its brand-name reference product is excluded from negotiation.
    • “The appeals court did not decide on the legality of the CMS’s “bona fide marketing” standard. It only determined that it should be considered by the lower court. 
    • “The district court never addressed whether CMS’s standard comports with the IRA, and we leave that question for it to consider in the first instance,” Circuit Judge J. Michelle Childs wrote.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Packaged-food makers are testing new strategies to appeal to consumers using GLP-1 weight-loss drugs, which suppress hunger and alter taste.
    • “JPMorgan estimates that GLP-1 treatments could drain $30 billion to $55 billion in annual revenue from the food and beverage industry by 2030.
    • “Companies like Conagra and General Mills are developing protein-rich products aimed at GLP-1 users.”
  • Health Day adds,
    • “Are you worried that extra pounds might be harming your health?
    • “Check the notches on your belt, a new study suggests.
    • “Waist size might be one of the simplest and most effective measures to detect health risks associated with obesity, researchers reported recently in JAMA Network Open.
    • “Pay attention to the need to loosen your belt or get bigger pants,” lead researcher Dr. Aayush Visaria said in a news release. He is a faculty member at Rutgers Health-RWJBarnabas Health Center for Climate, Health, and Healthcare in New Jersey. 
    • “Although clothing size isn’t the same as a proper waist circumference measurement, it can be an early sign of unhealthy amounts of body fat,” Visaria said. “Measuring your waist, along with your weight, can help identify health risks earlier and provide an opportunity to reduce your risk of diabetes, heart disease, stroke and some cancers.”
  • Cardiovascular Business relates,
    • “Rates of heart failure (HF) in the United States are stable or even beginning to decline. When it comes to HF with preserved ejection fraction (HFpEF), however, the numbers are on the rise. 
    • “This prompted the American College of Cardiology (ACC) to create an expert consensus decision pathway document focused on the efficient management of HFpEF patients.[1]
    • “The new document represents an update of the ACC’s 2023 recommendations, exploring new data to provide an abbreviated, practical guidance for patient management. The format was revised to associate treatment algorithms and tables to match the evolving clinical evidence.
    • “Despite advances in HF therapy, it remains a major consumer of healthcare resources and death worldwide. HFpEF accounts for more than 50% of new cases of HF each year and has outcomes comparable to heart failure with reduced ejection fraction (HFrEF). However, the consensus authors said HFpEF is often underdiagnosed and results in substantial resource utilization.”
  • and
    • “The use of artificial intelligence (AI) to identify incidental cardiac findings is a growing area of research, and now the identification of aortic stenosis (AS) is being tested on noncardiac chest CT scans. Cedars-Sinai Medical Center researchers are conducting a real-world study of an opportunistic algorithm that looks at all chest scans for the hallmark signs of AS.
    • “Some imaging experts have said this specific use of AI could serve as an early screening system to catch patients with heart disease years before they would become symptomatic, adding diagnostic value beyond why these scans were originally ordered. AS is one of the most common and serious heart valve disease problems, but most patients are unaware they have it at first and go undiagnosed until they become symptomatic. The American Heart Association (AHA), for example, believes there is still a sizable population of patients who remain undiagnosed or untreated.” 
  • Medscape offers physicians “Five Steps to Earlier Heart Failure Detection.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded scientific team has shown that under the right circumstances, 3D cell culture models of human brain tissue, known as organoids, can express features of later stage brain development. This breakthrough could turn previously unattainable, long-term, benchtop studies of neurodevelopmental disorders into a reality.
    • “The unprecedented longevity and lifelike qualities of these tissue models could afford us the opportunity to dig deeper into how conditions such as autism emerge and unfold later in life,” said Andrea Beckel-Mitchener, Ph.D., acting director of NIH’s National Institute of Mental Health (NIMH).”
  • Genetic Engineering and BioTechnology News adds,
    • “The Human Cell Atlas (HCA) was co-founded in 2016 by Aviv Regev, PhD, currently the head, executive vice president of research and early development at Genentech and Sarah Teichmann, FMedSci FRS, professor at the University of Cambridge and vice president translational research at GSK.
    • “This year, the group celebrated its 10-year anniversary, at the annual meeting in June, held in Boston. The first day was focused on the successes of the past decade. The second day looked ahead to the future, and the impact the HCA will make on research and drug discovery. GEN spoke with Holger Heyn, PhD, ICREA professor at the Centro Nacional de Análisis Genómico (CNAG) and co-founder of Omniscope about the meeting and what the next 10 years may bring. Heyn has been with the HCA since (almost) the beginning and currently serves as the co-chair of the Standards and Technologies working group, co-chair of the Industry Partnership Program, an organizing committee member, and a member of the task force to design HCA 2.0.”
    • The interview can be found in the article.
  • In the big research news of the day, the New York Times informs us,
    • “An experimental mRNA vaccine allowed people with high-risk melanoma to live longer, cancer-free, the pharmaceutical companies Moderna and Merck announced Wednesday.
    • “For decades, cancer vaccines have been one of the most tantalizing ideas in cancer treatment — offering the hope of harnessing a person’s own immune system to attack tumors.
    • “It’s a big deal,” said Dr. Elias Sayour, a pediatric oncologist at the University of Florida, who was not involved in the trial. The results, he said, “could help usher a whole new wave of new therapeutic treatments for cancer.” * * *
    • “The study is the most advanced of a number of trials testing the approach against a variety of cancers, including lung, bladder, kidney and pancreatic cancer. While small trials have shown the promise of the approach, the Moderna and Merck trial was seen as a bellwether in demonstrating the technology — and a first step toward transforming cancer care with treatments that are individualized to a person’s tumor and that may ultimately be able to stay ahead of it as it changes.”
  • The Wall Street Journal adds,
    • “Novo Nordisk is studying smaller doses of its Wegovy weight-loss pill to find the lowest dose that still allows patients to lose weight.
    • “The study began last week, has enrolled 450 overweight people and will test two low doses of the pill compared to a placebo.
    • “Novo Nordisk recently disclosed that uptake of the pill has been particularly strong for its lowest doses across self-paying patients.”

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

  • The Association of Healthcare Journalist reports,
    • “Investing more in primary care is linked to lower health care costs, according to a new report.
    • Journalists can cover this story nationally and locally, especially in rural areas where access to primary care can be more challenging, according to the report, “Investing in Primary Care: The Missing Strategy in America’s Fight Against Chronic Disease,” from the Milbank Memorial Fund.
    • “The report matters to reporters because it shows that adults and children with primary care physicians (PCPs) or a regular source of primary care have lower health care costs than those without.
    • “The report comes as Congress and President Trump are implementing changes under the 2025 budget reconciliation bill, cutting billions of dollars in federal Medicaid spending. Such a big decrease means low-income families could lose their Medicaid coverage, and not all physicians will treat the uninsured, the Milbank report notes. 
    • “The Milbank report is also timely because federal efforts since 2021 to increase the number of primary care doctors “have fallen short”, as Dennis Thompson reported for HealthDay. Primary care positions increased by just 2% under laws Congress passed in 2021 and 2023 to increase U.S. medical residencies, while residency positions in interventional radiology and psychiatry increased the most, rising by 16% and 13% respectively, he wrote, citing research JAMA published in June.” 
  • Beckers ASC Review adds,
    • “Physicians who once worked in a physician-owned practice before their current job are significantly more likely than their peers to be heading for the exit, according to the 2026 PAI Employed Physician Survey.
    • “Among physicians with prior experience in a physician-owned setting, 35% cite a lack of clinical autonomy as a reason they’re considering a new job, compared with 21% of physicians who’ve never practiced outside a corporate structure. They’re also more likely to say they plan to leave clinical practice entirely before retiring — 20% versus 12%.
    • “That group also reports operating under tighter terms: 63% are bound by a non-compete agreement, versus 48% of physicians without prior independent-practice experience, and 53% have patient-volume targets built into their compensation, versus 41%.”
  • Beckers Hospital Review relates,
    • “Altamonte Springs, Fla.-based AdventHealth recorded operating income of $916.2 million (13.4% operating margin) during the second quarter of 2026, up from $657.4 million (11.7% margin) during the same period last year.”
  • Beckers Health IT tells us,
    • “A year ago, health system CIOs walking the halls of Epic’s Users Group Meeting were still convincing themselves — and their boards — that generative AI in the EHR was more than a demo. This year, that debate is over. The new one is about speed.
    • “What strikes me overall is just the pace is blistering,” Tom Bentley, BSN, RN, chief information and digital technology officer of Columbus-based Ohio State University Wexner Medical Center, told Becker’s at the EHR giant’s sprawling headquarters in Verona, Wis. “Epic is cranking out new functionality, and I’m thinking what every CIO is thinking about: How do we increase our pace of adoption?”
    • “Epic used its Aug. 18 keynote to detail the scope of that push, including its Agent Factory platform that will soon allow health systems to build their own AI agents, the advancement of Cosmos-powered prediction tools called Curiosity, and the debut of an AI-assisted outpatient visit called Ergo.”
  • Beckers Payer Issues adds,
    • ‘The health systems and health plans that have pushed AI furthest into their operations are among the least equipped to prove what it is returning, according to a survey of 64 U.S. healthcare CFOs and finance leaders published Aug. 12 by Deloitte.
    • ‘Only 18% of organizations Deloitte classified as “AI scalers” said they have mature financial attribution capabilities, meaning they consistently measure AI’s effect on revenue growth or cost savings with defined baselines and clear ownership of key performance indicators. Among “AI starters,” 31% reported that level of maturity.’

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) through the Administration for Children and Families (ACF) today added new peer support programs to the Title-IV Prevention Services Clearinghouse, for which all states can now claim federal reimbursement. The expansion advances the Trump Administration’s Great American Recovery and A Home for Every Child initiatives by equipping states with evidence-based resources to help parents overcome addiction, thereby strengthening families and reducing the number of children entering foster care.
    • “HHS Secretary Robert F. Kennedy Jr., White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Initiative Kathryn Burgum, and ACF Assistant Secretary Alex J. Adams joined Governor Kim Reynolds in Des Moines to make the announcement.
    • “Addiction tears families apart. Recovery brings parents home and keeps children with the families who love them,” said HHS Secretary Robert F. Kennedy, Jr. “Under President Trump’s Great American Recovery, we are expanding proven peer support that helps parents overcome addiction, strengthens families, and keeps children out of foster care.”
    • “Iowa is proud to be first in the nation to adopt new peer-support interventions,” said Iowa Governor Kim Reynolds. “By responding to addiction and supporting struggling families, we’re building a stronger America: one where recovery is real, every child has a home, and hope is never out of reach for anyone.”
  • Federal News Network relates,
    • “Kevin Rhodes, the administrator of the Office of Federal Procurement Policy, is leaving federal service.
    • “A person with knowledge of the situation confirmed that Rhodes’s last day will be Sept. 4.
    • “The Senate confirmed Rhodes in October 2025, making him the first permanent OFPP administrator since 2019. He started working at OMB as a senior advisor in February 2025.
    • It’s unclear who will be acting OFPP administrator once he leaves.”
  • Fierce Healthcare tells us,
    • “The American Medical Association (AMA) said Monday it “welcomes” updated guidance from the U.S. Centers for Medicare and Medicaid Services (CMS) that strengthens federal transparency requirements for prior authorization.
    • “The country’s largest physician organization had documented concerns and recommended specific corrective actions to the agency in May (PDF), following the group’s review of how 15 Medicare Advantage contracts were implementing transparency provisions of the CMS Interoperability and Prior Authorization final rule. 
    • “The 2024 final rule requires payers to publicly post prior authorization requirements and outcomes, with a three-day deadline for urgent requests and a seven-day deadline for standard requests.” * * *
    • “The updated metrics reporting framework (PDF) clarifies that posting required metrics only through password-protected portals or “other locations that cannot be reached through ordinary navigation from the payer’s public-facing website” does not satisfy the rule’s “publicly accessible” requirement.
    • “The agency now also specifies that plans must publicly identify all medical items and services requiring prior authorization and identify omission of entire categories of care from disclosures. Moreover, it clarifies disclosures must be understandable and turnaround-time metrics must include a unit of time.”
  • The American Hospital Association informs us,
    • “The Centers for Medicare & Medicaid Services yesterday announced the launch of QualTech, a new event created to identify innovative technology that improves health outcomes. CMS is seeking participants from U.S-based teams, academic institutions, nonprofit organizations, private sector companies, industry associations and other stakeholders to propose technology solutions in advance of the event. Applicants must align proposal submissions to one of four priority opportunity areas: using artificial intelligence to protect patients and strengthen healthcare quality; leveraging AI to increase annual wellness visits in Medicare; proposing a next-generation digital quality measure calculator; and supporting the development of a national quality hospital dashboard. CMS will select finalists to present at QualTech, which will be held at CMS headquarters, to CMS and Center for Clinical Standards and Quality leadership and other attendees. CMS said it may continue engagement with select organizations following the event, which could include future demonstrations, pilots, collaboration discussions and a potential role in the 2027 CMS Quality Conference. Applications must be uploaded to the QualTech submission link by Sept. 4, 2026.” 
  • Managed Healthcare Executive points out,
    • “CMS implemented MFPs for 10 high-volume Part D drugs in January 2026 after 2024 discount announcements, with projected net savings of ~$6 billion (≈22%) across those products. 
    • “Surveyed beneficiaries reported countervailing cost signals: 46% paid more for at least one negotiated drug, 39% saw premium increases, and coverage changes increased out-of-pocket exposure for 29%. 
    • “Access friction intensified, with 30% reporting 2026 barriers versus 25% in 2025, most commonly prior authorization and drug availability constraints. 
    • “Knowledge gaps were substantial, as ~40% were unaware of the $2,100 out-of-pocket cap or the Medicare Prescription Payment Plan, undermining uptake of IRA cost protections. 
    • “Payer responses appear consistent with broader market behavior, including expanded step therapy, higher premiums, and stronger generic/biosimilar preferencing, particularly affecting diabetes, dermatology, and rheumatology.”

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

  • Fedweek reports,
    • “OPM has told agencies that they “must verify 100 percent of Open Season elections in which a family member is added” in FEHB/PSHB enrollments for calendar year 2027, sending them a survey for them to verify their readiness to do so.
    • “Enrollment of ineligible persons has been a long-running issue, the subject of congressional oversight and reports from the OPM inspector general and the GAO—most recently, in a GAO report on high-priority recommendations to the agency. The cost of claims from ineligible persons is widely estimated at $1 billion a year, raising premium costs for both enrollees and the government.
    • “In a benefits administration letter dated July 15 but only recently posted, OPM noted scrutiny has been tightened in a series of administrative steps, including in a prior letter requiring at least 10 percent of new family member enrollments and recommending review of all. Language in a broader budget measure enacted last year “codifies and elevates this standard by requiring verification of family member eligibility when an enrollee adds a family member during Open Season,” it said.
  • and
    • “Recently finalized rules requiring that employee performance evaluations fit a mandated pattern will apply to the rating cycle closing next month, OPM has said, a process that will involve “calibration” by senior agency officials that potentially will reduce many of the ratings set by employees’ supervisors.
    • “While a recent memo on carrying out the changes does not specify an implementation schedule, in response to questions from FEDweek, OPM said that what it calls “standardized” rating “applies to both the FY26 and FY27 performance appraisal cycles.”
    • “Agencies must establish a calibration program for the FY26 performance appraisal closeout no later than September 20, 2026 (end of FY26 appraisal cycle). Additionally, agencies must design their new GS performance management systems, and have them approved by OPM, prior to October 1, 2026 (for FY27 implementation),” it said.
    • “Applying a standardized distribution of ratings, and designing and implementing a calibration program, is effective for the closeout of the FY26 cycle,” it said, adding that it “will be publishing FY2026 performance appraisal cycle close-out guidance separately. We expect that guidance to be released in the next few weeks.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “President Donald Trump has chosen White House policy aide Heidi Overton to lead the Food and Drug Administration, according to a person familiar with the matter, after a turbulent year at the agency marked by high-profile staff exits and industry complaints.
    • “Overton is a deputy assistant to the president for domestic policy at the White House working on health issues. She previously worked at the think tank America First Policy Institute. Overton is a medical doctor and has a doctorate in clinical investigation from Johns Hopkins University. She was also a White House fellow in the first Trump administration.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial intelligence-enabled medical devices. The paper includes considerations for risk assessment, premarket evaluation, post-market monitoring and other areas. The agency intends to gather early stakeholder input and advance broader discussion on policy frameworks for generative AI. The FDA said comments must be submitted by Oct. 19.”  
  • MedPage Today adds,
  • Per a corporate news release,
    • “LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA) has approved an autoinjector for LEROCHOL® (lerodalcibep-liga) Injection 300 mg/1.2 mL, a third-generation Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor that combines robust and sustained efficacy with once-monthly, single injection self-administration to support long-term adherence.
    • “The FDA also approved an update to the LEROCHOL indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events (MACE) achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy.” * * *
    • “LEROCHOL autoinjector is expected to be available by January 2027 with a direct-to-patient cash price to match that of the already available pre-filled syringe at $199 per month.
  • BioPharma Dive explains that an “FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax.”
    • “Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.”

From the judicial front,

  • Beckers ASC Review reports,
    • “The American Association of Nurse Anesthesiology said July 21 that a U.S. Court of Appeals for the Sixth Circuit ruling wrongly declined to force HHS to enforce a provider nondiscrimination provision that protects certified registered nurse anesthetists from reduced insurance reimbursement.
    • “The Sixth Circuit based its ruling on associational standing, upholding a lower court’s finding that AANA lacked standing to bring the case. Mr. Molter said AANA is evaluating what the decision means for how trade associations pursue their members’ interests in federal court and is urging other associations to do the same.
    • “AANA President Jeff Molter, MSN,  MBA, CRNA, said the ruling does not endorse insurers’ practice of reimbursing CRNAs less than physician anesthesiologists for the same services. He called the decision procedural and said AANA maintains that such reduced reimbursement remains unlawful and discriminatory under current statute.”
  • The article points out nine other current anesthesia controversies.
  • Bloomberg Law relates,
    • “A federal judge in Massachusetts mostly upheld a 2025 Trump administration rule tightening oversight of Affordable Care Act exchange enrollment, adding to the legal saga dragging on over a 2026 version of the annual rule.
    • “Judge Nathaniel M. Gorton of the US District Court for the District of Massachusetts on Friday granted summary judgment for the administration in regard to provisions reducing the grace period for premium tax credit recipients to reconcile their income from two years to one year, shortening states’ open enrollment periods, increasing insurers’ flexibility to decrease the value of their plans, and changing the methodology for calculating cost-sharing amounts.
    • “But Gorton sided with the states in determining the administration did not follow the law in excluding certain “sex-trait modification procedures” from the ACA’s essential health benefits, noting that the government refused to issue a mandated report to Congress certifying that the provisions were aligned with a “typical employer plan.”
    • “When asked about the issue at oral argument, the government maintained its position that the Agency is not required to submit such a report, notwithstanding the Court’s clear ruling that it was required to do so,” he wrote in his opinion.” * * *
    • “Gorton’s opinion conflicts with the Maryland court, which rejected CMS’s ability to limit enrollment periods and increase flexibility for insurers to vary the value of their plans.
    • “CMS finalized several of the same provisions in its 2026 rule, prompting Democratic cities and states to sue again. The rule is now mostly frozen by the Maryland court.
    • “The case is California v. Kennedy , D. Mass., No. 1:25-cv-12019, opinion filed 8/14/26.”
  • The AP informs us,
    • “Luigi Mangione’s state murder trial in the killing of UnitedHealthcare CEO Brian Thompson, which was slated to begin Sept. 8, has been postponed indefinitely as his lawyers seek to have the case thrown out on double jeopardy grounds following his guilty plea last week to federal charges.
    • “Judge Gregory Carro issued an order Monday canceling the trial and giving the Manhattan District Attorney’s office, which is prosecuting the state case, until Oct. 9 to respond to the defense’s double jeopardy claims. A hearing will be held on Dec. 10, Carro said, about a week before Mangione is scheduled to be sentenced in the federal case.”

From the public health and medical / Rx research front,

  • The New York Times lets us know,
    • “What the Newest Research on Wildfire Smoke Tells Us
      • “Scientists have found that people are being exposed to more toxins than previously known.”
  • Cardiovascular Business adds,
    • “Long-term exposure to air pollution is associated with more advanced coronary atherosclerosis, including greater plaque burden and obstructive coronary artery disease, according to a large cardiac CT study published in Radiology.[1]
    • “Researchers led by Kate Hanneman, MD, MPH, associate professor and vice chair of research in the department of medical imaging at the University of Toronto, analyzed cardiac CT data from 11,128 adults who underwent clinical scans at three Toronto hospitals between 2012 and 2023. The study linked patients’ residential postal codes with air-quality data to estimate their average exposure to pollution during the 10 years before their CT examinations.
    • “What we found is that higher air pollution exposure, both gaseous and particulate, was associated with higher coronary calcium scores, higher plaque burden, and obstructive coronary disease in unadjusted models,” Hanneman explained a video interview with Cardiovascular Business at SCCT2026, the Society of Cardiovascular Computed Tomography (SCCT) annual meeting. “When we adjusted for age, sex, and traditional cardiovascular risk factors, we found that in women, higher air pollution was also associated with obstructive disease, even in these multi-variable models. So this really builds on the existing literature that tells us that higher air pollution is not good for us and it’s not good for our heart.”
  • Genetic Engineering and Biotechnology News reports,
    • “Mass General Brigham Cancer Institute researchers found that consuming one or more sugar-sweetened beverages every day was associated with an increased risk of developing gastric cancer, while artificially sweetened beverages were not associated with an increased risk. Results from the study were published in Gastro Hep Advances, in an article titled “Association between sugar-sweetened and artificially sweetened beverage intake and gastric cancer incidence.”
    • “Previous research has linked sugar-sweetened beverages with an increased risk of colorectal, breast, and liver cancers, but evidence on gastric cancer has been limited. The study analyzed data from 112,284 participants in the Nurses’ Health Study and Health Professionals Follow-Up Study. Both studies gathered detailed diet, lifestyle, and health information on U.S. adults over many decades. During the follow-up period, which spanned decades, 278 participants developed gastric cancer.
  • MedPage Today adds,
    • “A group of physicians and scientists are calling on the National Collegiate Athletic Association (NCAA) to make changes to its massive collaboration between Big 12 athletics and Monster Energy, citing potential health risks and teen deaths associated with energy-drink consumption.
    • “As part of the partnership announced last month, Big 12 football and basketball athletes will don Monster Energy-branded jerseys during the regular seasons, and the fields and courts where teams play will display the popular energy drink’s logo.
    • “Virginia-based ophthalmologist David Jacobs, MD, noticed the prominent branding of the energy drink when he went to visit his kid’s Big 12 school, and later became concerned about how the campaign could influence children.
    • “Jacobs is an alum of a Big 12 school, as is his friend, Idaho-based cardiologist Matthew Nelson, MD. The two began reaching out to other cardiologists and created the Protect Young Fansopens in a new tab or window public health initiative, which, as of press time, has gathered over 250 signatures on their petitionopens in a new tab or window asking the NCAA to end the Monster Energy partnership.
    • “We’re concerned about an increase in energy drink consumption among children and youth,” Jacobs told MedPage Today. He noted that with high-profile Big 12 sports in particular, impressionable kids will be looking up to and copying their sports idols.
    • “Their concerns are not abstract, according to an email to NCAA leadership from Jacobs, Nelson, and other physicians and scientists that was shared with MedPage Today.”
  • The American Hospital Association News relates,
    • “For the 2025-2026 school year, exemptions from one or more vaccines among U.S. kindergartners was at 4.2%, increasing from 3.6% for the previous school year, according to data released yesterday by the Centers for Disease Control and Prevention. Exemptions rose in 41 states and Washington, D.C. Vaccination coverage declined for all reported vaccines from the previous year. Coverage with the measles, mumps and rubella, or MMR; diphtheria, tetanus, and acellular pertussis, or DTaP; polio and varicella vaccines decreased in more than half of states. The CDC said there were approximately 280,000 kindergartners that attended school in 2025-2026 without documentation of completing the two-dose MMR vaccine.” 
  • MedPage Today adds,
    • :The hepatitis A vaccine is recommended for high-risk children and adults, while the hepatitis B vaccine is recommended for all adults under 60 years.
    • “In this study, researchers estimated that 40% of U.S. adults had immunity to hepatitis A and 27% were immune to hepatitis B virus.
    • “Levels of immunity against hepatitis A and hepatitis B viruses were “suboptimal” and persisted across high-risk groups, according to the researchers.”
  • and
    • “Despite routine rotavirus vaccination in over 140 countries, the virus still causes an estimated 25% of diarrhea deaths in children younger than 5 years.
    • “In a retrospective study of children ages 3 months to 4 years, receiving at least one dose of a rotavirus vaccine was 75.8% effective at preventing rotavirus-positive acute gastroenteritis death.
    • “Rotavirus vaccination was less effective against all-cause acute gastroenteritis mortality, at 20.8%.”
  • Beckers Clincal Leadership tells us,
    • “Blacklegged ticks carrying Lyme disease have expanded into the mountains of western North Carolina, far south of the disease’s traditional Northeast and Upper Midwest range, according to an Aug. 13 CDC report.
    • “Researchers surveilling 22 residential properties in Biltmore Forest, N.C., near Asheville, collected 373 ticks from November 2024 through August 2025, according to the CDC’s “Morbidity and Mortality Weekly Report.” Blacklegged ticks — the primary Lyme vector — made up 287, or 76.9%, of them.
    • “Nearly 40% of the adult blacklegged ticks, or 19 of 48 specimens, tested positive for Borrelia burgdorferi, the bacterium that causes Lyme disease. Three of seven nymphs also carried it.
    • “Nineteen residents across 17 households reported at least one tick-borne illness while living in the town, the CDC report said. Lyme disease was the most common, with 17 cases, followed by two cases of babesiosis and one of ehrlichiosis.
    • “The findings point to an emerging clinical blind spot. Many clinicians across the South have little experience diagnosing or managing tick-borne disease, the report’s authors said, and may not consider Lyme in patients with no travel history to endemic regions.”
  • Beckers Hospital Review informs us,
    • “Nearly every U.S. hospital screens patients for sepsis, but far fewer have dedicated personnel to ensure screening is successful, the CDC found. Moreover, separate research links a lack of specific accountability to higher mortality.
    • “In its latest annual survey of hospital sepsis programs, covering 2025, the CDC found that 93% of 5,430 hospitals have a standard process to screen for sepsis and 87% use order sets tailored to their patients. But only 36% employ a sepsis coordinator to oversee day-to-day operations, and 32% have support from staff with expertise in data, analytics and information technology.
    • “When it comes to reporting, 31% of hospitals share sepsis data with nursing, physician, unit and hospital leadership at routine intervals. At the remaining two-thirds of U.S. hospitals, that data does not reach leaders on a regular basis.
    • “Sepsis accounts for about 1.7 million adult hospitalizations per year, 350,000 of which end in death or discharge to hospice — more than a third of all hospital deaths, according to the CDC.”
  • The American Medical Association lets us know “this superbug’s toll exceeds 3,400. How to protect your loved ones.”
    • “The Candida auris fungus is spreading. Here’s what to know about the superbug, who’s most at risk, symptoms and what your next steps should be.”
  • Health Day points out,
    • “Many smokers still haven’t absorbed the fact that smoking and secondhand smoke cause heart attacks and strokes, despite decades of messaging around tobacco’s health risks, a new study says.
    • “More than 90% know that smoking causes lung cancer, but fewer know about its links to other fatal conditions, researchers report in the journal BMJ Open.
    • “Only about 80% knew smoking contributes to heart disease and heart attacks, and 70% are aware it causes strokes, researchers found.
    • “In fact, across two decades they found almost no progress in knowledge of the health risks associated with smoking.
    • “Knowledge gaps about the major health effects of smoking and secondhand smoke are deeply concerning,” said lead researcher Janet Chung-Hall, a research scientist for the International Tobacco Control Policy Evaluation Project at the University of Waterloo in Canada.”
  • and
    • “There’s been a nearly 400% increase in calls to U.S. poison centers related to liver injuries, mostly related to Tylenol and other medications, a new study says.
    • “Liver injuries caused by foreign substances skyrocketed from an estimated 11 cases per million people to nearly 53 cases per million between 2000 and 2024, researchers reported Aug. 13 in the journal Clinical Gastroenterology and Hepatology.
    • :Medications accounted for most of these liver injuries, including 85% of cases among men and 94% of cases among women, researchers found.
    • “Acetaminophen (Tylenol) was the drug most frequently implicated in liver injuries reported to poison centers, researchers said. About 33% of men and 45% of women reported injuries due solely to Tylenol.”
    • “Liver injuries reported to poison centers have increased substantially over the past 25 years, with acetaminophen emerging as a growing contributor,” researcher Dr. Christopher Holstege, director of the University of Virginia Health’s Blue Ridge Poison Center, said in a news release.”
  • Per BioPharma Dive,
    • A once high-flying Boston-area drug company mounted somewhat of a comeback Tuesday, reporting positive results from a clinical trial testing a potentially first-of-its-kind treatment for the dangerously low blood sugar levels some patients experience after bariatric surgery.
    • Amylyx Pharmaceuticals said its medicine, known as avexitide, hit the main goal of the late-stage study by spurring a 55% reduction in serious to severe hypoglycemic events compared to a placebo. Such events starve the brain of the sugar it needs for fuel, leading to confusion, dizziness, slurred speech and loss of coordination. In more dire cases, patients can faint, have seizures or become comatose.
    • “According to Amylyx, its medicine also appeared safe. Researchers classified a majority of the adverse events seen in the trial as mild or moderate, with the most common being diarrhea and bruising or redness at the injection site. Amylyx now plans to, before the end of the year, formally ask the Food and Drug Administration to approve avexitide.”

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

  • Healthcare Dive reports,
    • “CVS has added Teresa Heitsenrether, JPMorgan Chase’s chief data and analytics officer, to its board of directors as the healthcare behemoth continues to progress on its financial turnaround.
    • “Heitsenrether has spent four decades in financial services, according to Monday press release announcing her appointment. She’ll be joining CVS effective Nov. 18.
    • “CVS also said that Larry Robbins, who served on the board’s audit and public policy and external affairs committees, left earlier this month. Robbins, the CEO of Glenview Capital Management, joined the board in 2024 after the hedge fund pushed for changes at CVS.”
    • “As the leader of JPMorgan’s data and analytics, Heitsenrether sets strategy and governance standards, while driving the bank’s adoption of artificial intelligence.”
  • Beckers Payer Issues relates,
    • “UnitedHealthcare expanded its child and family behavioral coaching program, giving approximately 13 million eligible commercial members access to behavioral health support. 
    • “The 2026 expansion adds access for an additional 5 million members at no added cost for employers with fully insured plans. More than 500 employers now offer the program, according to an Aug. 18 news release from the company. 
    • “The program addresses mild to moderate anxiety, attention-deficit/hyperactivity disorder, bullying, depression and sleep difficulties, with participants being 12 years old on average. It offers up to four virtual coaching sessions per month, appointments within 48 hours, unlimited secure messaging and educational resources, and access to health and wellness coaches. Members can also be referred to licensed clinicians when higher-level care is needed.”
  • and 
    • “Blue Cross Blue Shield of Tennessee has the highest-ranked Medicare Advantage plan for member satisfaction in 2026, according to JD Power’s 12th annual Medicare Advantage study.
    • “The consumer insight firm published its annual ranking of the top MA plans in 12 markets on Aug. 18 after surveying more than 14,500 enrollees and evaluating plans on eight factors, including level of trust, ability to get health services when and how members want, helping save time or money, product and coverage offerings, ease of doing business, customer service representatives, problem resolution and digital channels.
    • “The average member satisfaction rating for MA plans this year is 611 on a 1,000-point scale, down 12 points from 2025 and down 41 points from 2024, marking a second consecutive year of decline.
    • “Satisfaction dropped across all dimensions of the member experience, with the largest two-year declines in areas tied to helping members save time and money, level of trust and whether coverage offerings met member needs. Fewer than half of plan members said they strongly agreed their plan is a trusted partner in their health and wellness. High-performing plans distinguished themselves through stronger new-member onboarding and communication, while special needs plans delivered significantly higher satisfaction and trust scores overall.”
  • Fierce Healthcare tells us,
    • “While operating margins trended upward in June, hospitals’ overall performance still lags 2025 and is seeing “intensifying” uncompensated care pressures and faster-than-inflation expense growth, according to the latest monthly benchmarks from Kaufman Hall. 
    • “The healthcare advisory firm reported a calendar year-to-date operating margin index of 2.5% and a single-month operating margin index of 4.5% (both including health system allocations for the cost of shared services). The former is a 6% lag compared to the first half of 2025, while the latter reflects a 6% bump over this May’s median operating margin.
    • “Echoing commentary from some of its preceding reports this year, Kaufman Hall’s primary red flag was a 2% month-over-month increase in daily bad debt and charity logged by hospitals, which year-to-date is 17% higher than the same cutoff in 2025. As a percentage of hospitals’ gross operating revenue, year to date, uncompensated care is 8% higher than 2025.” 
  • STAT News adds,
    • “For Bon Secours Mercy Health, Ensemble Health Partners is the gift that keeps on giving. 
    • “Seven years after the nonprofit health system sold stakes in its in-house billing and collections company to private equity investors, it still rakes in eye-popping amounts of cash from its minority position, with payments topping $1 billion so far this year.
    • “About two weeks ago, the Cincinnati-based system said it got a hefty $671 million payment from Ensemble Health Partners when the company signed a new private equity sponsor. That’s on top of a $427 million distribution Bon Secours Mercy recorded in February. Both payments were reported on the nonprofit system’s financial report for the second quarter, which ended June 30. 
    • “The $1.1 billion Bon Secours Mercy received from its 41% stake in Ensemble across the two payments far exceeds the system’s operating income in the first half of the year, which was $225 million. The health system generated $7.5 billion in revenue in the first six months of 2026, compared with $6.9 billion in the first half of 2025.” 
  • Beckers Hospital Review adds
    • “After years of high length-of-stay averages, hospitals are reporting significant length-of-stay reductions.”
      ,
  • Beckers Payer Issues notes,
    • “Montgomery, Ala.-based Jackson Hospital has filed to exit bankruptcy and signed a four-year deal with Blue Cross Blue Shield of Alabama, John Quinlivan, CEO of Jackson Hospital, said during an Aug. 17 news conference. 
    • “The BCBS agreement will become active once the exit is complete.
    • “The agreement does not give us everything we felt we needed, but combined with the continued support of Blue Cross Blue Shield of Alabama, Jackson Investment Group, the City of Montgomery, Montgomery County and the State of Alabama, it enables us to execute our strategic plan,” Mr. Quinlivan said. “We will enhance operational discipline, improve quality, expand services and add new services as we grow and innovate to better serve Montgomery and the Central Alabama region.”
  • Per Beckers Physician Leadership,
    • “Corporate entities now employ 82% of U.S. physicians, and about nine out of 10 physicians in employed settings are reporting symptoms of burnout, according to a new survey.
    • “The Physicians Advocacy Institute and Healthsperien’s Center for Health Research, Policy & Strategy surveyed more than 1,000 hospital- and corporate-employed physicians and found widespread burnout, administrative burdens and pressure to put corporate interests ahead of patient care.”
  • Per Fierce Healthcare,
    • “Four health systems are now using real-time prior authorization checks embedded in the Epic electronic health record, tackling a major pain point for providers.
    • “The electronic health record giant collaborated with insurers UnitedHealthcare, Network Health and Aetna to set up the electronic workflows to modernize the manual and time-consuming prior auth process.
    • “Epic launched real-time insurance reviews directly into EHR workflows using an industry-standard application programming interface (API) called Coverage Requirements Discovery (CRD). Epic is testing the API with 16 additional payers to support wider industry adoption, the company announced Monday as its annual Users Group Meeting kicks off in Verona, Wisconsin.”

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.

Weekend Report

David Ermer–Agentic & Generative AI, CDC, Congress, COVID-19, Medical / Rx research, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • The House of Representatives is on a District work break until August 31, 2026, and the Senate is on State work break until September 14, 2026.
  • The Western Journal discusses the federal government’s efforts to stop paying benefits to beneficiaries who have passed away. FEHB and PSHB plans, as private entities, cannot use the federal government’s Do Not Pay system. It obviously would be helpful if OPM used the HIPAA 820 enrollment roster transaction which would allow FEHB and PSHB plans to reconcile premiums payments with individual enrollees. The HIPAA 820 tranaction has been in use since 2012, and FEHB and PSHB plans are reportedly the only plans serving large employers that do not benefit from the HIPAA 820.

From the public health and medical / Rx research front

  • IFL Science reports,
    • “Currently, there are more COVID cases in [California] than there were during the winter season. It is thought that this is being driven by the mutated “cicada” variant.
    • “Known more formally as BA.3.2, the variant was first identified in southern Africa in 2024. Since then, it has spread around the world, having now been detected in least 32 countries, including Australia, Germany, and the US.
    • “The variant has caught the attention of virologists and researchers because it has more than 70 spike mutations compared to the original wild-type virus.” * * *
    •  “Our summer peak was much higher in 2025 than it was in the winter,” Dr. Erica Pan, director of the California Department of Public Health and the state public health officer, said in a briefing.
    • “Summer is really the bigger peak. So if you do have patients or loved ones who have not gotten the ’25-’26 vaccines, it is still effective and highly recommended, given this surge we’re starting to see.”
    • “It seems that the shift from bigger winter to summer peaks started to occur around 2024. While so far this has been more noticeable in California, there is also evidence for this trend emerging right across the country.
    • “Why it is happening, and if the trend will continue, is still unknown.
    • “What is known, however, is that the COVID vaccines are safe and effective. A newly formulated shot is expected in the coming fall, but those at an increased risk of the disease can get a booster shot earlier if needed.”
  • The American Medical Association lets us know,
    • “One case of measles is concerning. Thousands are a warning.
    • “Our nation is experiencing the largest measles resurgence in decades—even though we have had a vaccine for more than 60 years. This year’s case count has already surpassed the total reported in all of 2025, making 2026 the worst year for measles our country has experienced in decades.
    • “For many physicians, measles is something they have read about rather than seen firsthand. That is a testament to the success of vaccination. It is also a reminder that vaccine-preventable diseases return when vaccination rates decline.
    • “For all clinicians, this resurgence is more than a public health statistic. It is a reminder that conversations about vaccination remain among the most important forms of preventive care we provide”
  • PBS News adds,
    • “The nationwide cyclospora outbreak is very likely a result of sewage contaminationin the food supply, according to scientific researchers and public health officials.” * * *
    • “As floods and droughts occur routinely across the U.S. and around the world, sewage may overflow into bodies of water or be used directly on crops. That increases the risk that diseases, including protozoa such as cyclospora, which are transmitted through ingestion of fecal matter, may spread through food and water supplies.
    • “And because cyclospora oocysts mature in outdoor heat, it is possible that increasing temperatures, such as heat domes, could speed up their maturation, exposing more people to the infectious form of the parasite.
    • “Modern technology and techniques are capable of monitoring water quality, detecting harmful pathogens and eliminating them. Expanding monitoring of wastewater for protozoan diseases and other dangers can help prevent outbreaks and slow the spread of disease from sewage-contaminated water in the future.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Memories can survive even after the brain temporarily loses more than half of its synaptic connections, according to the results of a study in mice that challenge the long-held view that long-term memories depend on stable individual synapses. The researchers, headed by a team at Okinawa Institute of Science and Technology (OIST), and including teams at the University of Tsukuba, Exploratory Research Center on Life and Living Systems (ExCELLS), and National Institutes of Physiological Sciences, used a mouse model of artificial hibernation to examine structural mechanisms underlying memory retention.
    • Their findings indicate that memory may be preserved not through individual synapses, but through resilient patterns of neural architecture, including specific clusters of connected synapses that remain protected during widespread hibernation-associated brain remodeling. These preserved structural motifs could act as a “core memory trace,” allowing the brain to rebuild functional networks after major disruptions.
    • “Research lead Kazumasa Tanaka, PhD, head of OIST’s Memory Research Unit, said, “Previously, synaptic strengthening was thought to be key to memory recall, and that stronger synapses with larger dendritic spines were fundamental to long-term memory retention. Here, we show that not every synapse matters, and demonstrate instead the vital importance of engram architecture. The study indicates that small clusters of engram-engram synapses are preserved to enable accurate recall even after hibernation.”
    • “Tanaka is senior and corresponding author of the team’s published paper in Science, titled “Artificial hibernation reveals synaptic engram architecture associated with memory retention.”
  • Health Exec points out,
    • “Higher doses of semaglutide were associated with significantly lower cardiovascular risk in patients with pre-existing cardiovascular disease, while the amount of weight loss achieved did not appear to predict subsequent cardiovascular protection, according to a large real-world analysis. This was according to a new article in the journal Nature.[1]
    • “The findings raise the possibility that semaglutide’s cardiovascular effects extend beyond weight reduction. This adds to growing clinical data showing how GLP-1 drugs are having a positive impact on patient health separate from weight loss outcomes.
    • “The degree of weight loss surprisingly did not correlate with cardiovascular protection as measured by all-cause mortality or multiple individual incident disease diagnoses,” explained lead author Karthik Murugadoss, a data scientist with nference and its Metabolism Agentic Intelligence Atlas (MAIA) initiative. “In a direct comparison of semaglutide to other anti-diabetic medications, semaglutide was associated with reduced rates of multiple cardiovascular endpoints after treatment initiation.”
    • “He said the findings suggest a cardioprotective role of semaglutide which may be related to attained dose, but is not explained simply by the amount of weight loss achieved while on therapy.”

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

  • The Wall Street Journal reports,
    • “Patients, families and healthcare professionals are turning to AI tools to help identify rare and hard-to-diagnose diseases.
    • “A study published in a JAMA journal found that two AI chatbots suggested the correct rare-disease diagnoses more often than doctors did.
    • “Doctors and researchers caution that AI tools still make mistakes and are limited by a lack of digitized data for rare conditions.”
  • Beckers Payer Issues relates,
    • “Point32Health, the parent organization of Harvard Pilgrim Health Care and Tufts Health Plan, logged an adjusted net income of $68 million for the second quarter of 2026. 
    • “According to an Aug. 14 update shared with Becker’s, this profit was up from an adjusted net loss of $25 million during the same period in 2025.
    • “For the second quarter of 2026, operating income was $38 million. The operating loss in the second quarter of 2025 was $57 million.
    • “Point32Health had 1.9 million members during the second quarter of 2026, slightly down from 2 million members during the same time in 2025. Revenue was $2.3 billion for the second quarter of 2026, down about 4% year over year.”
  • and
    • “Health insurers denied between 12% and 18% of standard prior authorization requests across Medicare Advantage, Medicaid managed care and ACA marketplace plans in 2025, with wide variation among the largest payers, according to a KFF analysis published Aug. 13.
    • “CMS previously finalized a rule requiring certain insurers to publicly report prior auth metrics, including denial rates, processing times and appeal overturn rates. The first reports, covering 2025, were due March 31. The data is aggregated across all items and services, with no breakdown by service type, so there’s limited insight into what services are being approved or denied. Payers are also not required to report reasons for denials.
    • “The rankings below only cover standard prior auth requests and they don’t include data for prescription drugs (though CMS has proposed a rule to require that information to be public as well). Denial rates for urgent requests, which are included in KFF’s analysis, were slightly lower across all markets.
    • “Prior auth denials are rarely appealed, but when they are, a considerable share are overturned, including 67% for Medicare Advantage plans, 47% in Medicaid managed care and 43% in the ACA marketplace.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity, HIPAA Privacy and Security Rules–

From the Project Glasswing front,

  • Cyberscoop reports,
    • “OpenAI announced Monday [August 10, 2026] it was expanding access to its frontier models for defensive cybersecurity, detailing different defensive and red-teaming workflows and a new partner program with major cybersecurity product providers.
    • “In a pair of blogs posted Monday, OpenAI said it was updating its Daybreak program  – which provides unreleased frontier models to private organizations and governments for defensive cybersecurity work – and introducing a new model variant.
    • “Daybreak Blue, powered by OpenAI’s ChatGPT-5.6-Sol, would operate with lower cybersecurity safeguards compared to other commercially available models and is described as “a recommended starting point for most defenders” that supports tasks like vulnerability discovery, secure code review, malware analysis, incident response and patch validation. 
    • “Daybreak Red, meant for more advanced red-teaming, would provide access to a new model, dubbed GPT-5.6-Cyber, that the company said is more purpose-trained for finding vulnerabilities and testing (or exploiting) them. The model is also less likely to refuse requests around “dual-use cyber tasks.”
    • “According to OpenAI, the organizations in Daybreak Red will have their use closely monitored and supervised, as GPT-5.6-Cyber is significantly more capable in carrying out malicious cyber tasks than Sol. A security evaluation the company devised tested both models on complex requests, including exploit chain development, authentication bypass, privilege escalation and other hacking tasks. Sol succeeded in 1.5% of the requests, while Cyber completed 95%.
    • “OpenAI said it plans to publish a more detailed system card for GPT-5.6-Cyber at a later date.”
  • Cryptobriefing adds,
    • “Anthropic has disclosed an unreleased internal AI model that it says is more capable than Claude Mythos 5, according to the company’s August 2026 Risk Report.
    • “The model, referred to only as Model 2, represents a noticeable improvement over Mythos 5 across many tasks relevant to Anthropic’s internal work. The company said the improvement is smaller than the capability jump it previously observed between Claude Opus 4.6 and Mythos Preview.
    • “Anthropic said it does not currently plan to release Model 2 externally and has not completed its full suite of typical predeployment assessments, leaving the company with somewhat lower confidence in its understanding of the model’s capabilities.”
  • Silicon Angle points out,
    • “Data resilience company Rubrik Inc. today said a month of scanning its own code with Anthropic PBC’s Mythos Preview model surfaced so many potential security issues that it rebuilt its review pipeline rather than hire reviewers.
    • “The details came in a blog post from Rubrik co-founder and Chief Technology Officer Arvind Nithrakashyap. Rubrik got access in June to Project Glasswing, Anthropic’s limited program that gives defenders early use of Mythos Preview, after the company opened it to another 150 organizations. Anthropic has kept that model out of general release. Mythos finds software flaws and strings them into working attack chains too well to hand out freely.
  • Tech Crunch relates,
    • “What happens when you pit AI agents against each other? According to Anthropic’s testing, things get messy fast.
    • “On Thursday [August 13, 2026], Anthropic’s Frontier Red Team published new research examining how groups of AI agents behave when they encounter each other in the wild. The findings provide a glimpse into potential risks that could develop as companies and governments move to implement agents working autonomously across shared codebases, markets, and computer systems.
    • “In one experiment, Anthropic gave three Claude agents access to the same software project, each with its own incompatible instructions for what to do with it. The agents weren’t told there’d be other agents working on the same project, so researchers could watch what happened when they crossed paths. 
    • “We consistently saw a multiagent turf war,” Anthropic researchers wrote. The models all assumed the others were “purposefully impeding their work” and started sabotaging each other with “increasingly aggressive, self-replicating malware.”
  • CNBC notes,
    • “Over the past two weeks, OpenAI, Anthropic and Meta all revealed that their AI models went rogue during routine security testing. In explaining what happened, the companies each mentioned the same small Israeli startup: Irregular. 
    • “Founded three years ago and based in Tel Aviv, Irregular is a niche player in artificial intelligence, backed with $80 million from Sequoia and Redpoint Ventures and valued last year at $450 million. Its technology serves as a sort of cybersecurity test bed for AI models. 
    • “With the leading models becoming ever more powerful, their ability to act in malicious ways is turning into a major threat for corporations and governments, especially as the risk involves hacking into critical computer systems and infrastructure. The recent exploits at OpenAI, Anthropic and Meta all involved their AI models accessing websites that should have been off-limits as part of the cybersecurity testing.” * * *
    • “Meta, which is way behind the other two in its effort to compete at the frontier, was the latest to disclose an AI model hacking a third-party system by accessing the internet. A spokesperson said in a statement this week that the company learned about the matter from Irregular and is investigating.
    • “Meta “will issue a full retrospective once we have all the facts,” the spokesperson said.
    • “Irregular told CNBC in a statement that the incidents were all derived from the “same evaluation-environment issue” that was first disclosed by Anthropic, and that the company is developing a white paper “to share best practices for containment and securely running cyber evals.”
    • “The situation “did not involve a sandbox escape or a sophisticated cyber action,” the company said, adding that “there are no current open issues.”
  • On a related upbeat note, the Wall Street Journal informs us,
    • “U.S. startups are finally delivering something researchers have been working on for decades: a battery in which rare, hard-to-get elements are replaced with the same stuff found in ordinary table salt.
    • “This tech has the potential to help every country on earth break its dependence on China for batteries, and the critical minerals that go into them.
    • “Like any other battery, sodium-ion cells can store and release energy. They are initially being deployed where they’re needed most, in America’s power grid and fast-expanding crop of data centers. As in our homes, giving the grid or other infrastructure the ability to stockpile energy when it is cheap and plentiful, and discharge it when it is scarce, can increase reliability and lower the cost of electricity.
    • “While grid battery storage is already growing in the U.S. at a furious pace, new sodium-based batteries are potentially cheaper, longer-lasting, safer and more reliable than conventional, lithium-based ones. They could accelerate the rollout of renewables, and be part of less-polluting alternatives to natural-gas turbines and diesel generators.”

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive reports,
    • “The Trump administration will let private companies hack foreign criminal organizations as part of a new program that could expand the U.S. government’s ability to disrupt those groups’ cybercrime activities while also introducing myriad legal challenges and perils.
    • “President Donald Trump late Wednesday [August 12, 2026] issued a memorandum directing the departments of Justice and Homeland Security to create a program allowing vetted companies to hack into criminal groups to spy on them or sabotage their operations. Trump said the program would help the U.S. combat cybercrime schemes that cost the nation tens of billions of dollars annually.” * * *
    • “Jason Healey, a senior cyber conflict researcher at Columbia University, said he “would have hated this idea ten or fifteen years ago” when the opportunity still existed to prioritize defense over offense. “But that horse left the barn a long time ago,” he said, “and we have to make decisions for the world we are in, not the one we prevented.”
    • “So, sure, let’s try to allow the private sector to get into the counter-offense game as well,” he said, “but only with very specific criteria to know when it is working and when it is making things worse.”
    • “Kyle Hanslovan, chief executive of the cybersecurity firm Huntress, said the growth of sophisticated adversaries and the threat of “AI-powered autonomous threats” meant that old models of public-private collaboration were no longer sufficient. “The only viable solution is a stronger coalition of the willing,” he said, “which we’ve been eager to support.”
    • FEHBlog note – Of course there are those questioning the memo as discussed in the article.
  • Cyberscoop adds,
    • “Under the memorandum, a federal coordination center “shall create, manage, and maintain a Program to authorize Participating Companies … to conduct Cyber Surveillance Operations and Cyber Effects Operations against foreign Cyber-Enabled Transnational Criminal Organizations (CE-TCOs), under the control and oversight of the Federal Government“ that would be “part of lawful investigatory, protective, or intelligence operations carried out by Federal law enforcement.”
    • Department of Homeland Security to “undergo rigorous vetting.” It would also allow participating companies to sign commercial agreements with other private sector entities to receive threat information. And participating companies’ agreements with federal, state and local governments would be geared toward identifying threats, and proposing cyber operations to the coordination center to address those threats.
    • The program would have to adhere to existing laws, according to the memo. That includes the Computer Fraud and Abuse Act, the main federal anti-hacking statute that prior proposals to open private sector participation in hacking operations would have amended. The memo mandates oversight to evaluate companies’ technical proficiency, ensures both small and large companies can participate, and requires regular reporting to federal officials.
  • and
    • Under the memo, the program must establish legal and constitutional procedures for the prior approval of the targeting of U.S. citizens, as well as develop procedures to halt any unintentional targeting of U.S. people or systems. * * *
    • “The coordination center charged with establishing the program under the memo has 60 days to complete its work. That process could determine a lot. Graham noted that the memo has a classified annex, too.
    • “The memo as written is quiet about what becomes of any seized assets, Graham noted.” * * *
    • “Will Barker, cybersecurity adviser at Huntress, said what’s next could be key.
    • “The 60-day implementing guidance is where the real substance lives,” he said in a written quote. “Minimum standards, operational procedures, the adjudicatory framework for target selection.”
  • MedTech Dive tells us.
    • “The Coalition for Health AI has convened a work group of nearly 100 health system, payer and industry leaders to address cyber risks associated with frontier artificial intelligence models, the nonprofit standards organization announced Wednesday.
    • “The group will meet biweekly with the goal of creating and publishing health AI cybersecurity guidance by the end of 2026. Deliverables include an AI cyber risk assessment tool and playbooks covering both defensive and offensive security strategies.
    • “Anthropic’s release of its advanced Mythos and Fable AI models this spring “fundamentally changed” the cyber threat landscape for healthcare, and was a catalyst to stand up the work group, CHAI said.”
  • Cyberscoop informs us,
    • “A tech worker who hatched an elaborate insider attack in late 2023 and attempted to extort Brightly Software for about $2.5 million was sentenced to two years in prison, the Justice Department said Thursday.
    • “Cameron Nicholas Curry, also known as “Loot,” committed a series of crimes while working as a data analyst contractor for the Siemens-owned company. The 27-year-old North Carolina man stole a trove of corporate data, including sensitive employee and compensation information, which he used to threaten various employees and executives over a six-week period in late 2023 and early 2024. 
    • “Curry ultimately extorted the company for $7,540.92 in late January 2024. He was found guilty of six counts of extortion in March.
    • “Brightly Software was named as the victim in court records filed in the U.S. District Court for the Western District of North Carolina earlier this month. The asset and maintenance management software provider, which Siemens acquired in 2022, did not immediately respond to a request for comment.”

From the cybersecurity breaches and vulnerabilities front,

  • The HIPAA Journal discusses data breaches announced by five HIPAA-regulated entities.
  • Bleeping Computer reports,
    • “The ShinyHunters extortion group stole personal information from 1.6 million RingCentral accounts after hacking the company in July, according to the data breach notification service Have I Been Pwned.
    • “RingCentral is a cloud-based collaboration and communication platform used by over 600,000 businesses for services such as calling, messaging, and voicemail.
    • “The company disclosed the incident on July 28, revealing that its systems were compromised following what it described as a “sophisticated social engineering campaign.”
  • Cyberscoop relates,
    • “As the White House and federal agencies grapple with frontier AI models and their hacking capabilities, researchers are warning that the industry’s “middle class” of smaller models may end up posing a greater threat over the long term.
    • “Research from XBOW this week shows that a growing class of both proprietary and open-source models are becoming strategically important in the offensive security ecosystem. Models like Z.ai’s  open-weight GLM-5.2, xAI’s Grok 4.5, Anthropic’s Opus 4.7, Meta’s Muse Spark 1.1, still perform very strongly at many hacking and exploitation tasks that worry policymakers.
    • “It’s not even that the open-source variants or…not quite frontline competitors are catching up [to frontier models] as such,” said Albert Ziegler, head of AI at XBOW. It’s that they are crossing a certain threshold, which means that suddenly they are providing net value at a cheaper price.
    • “That wasn’t necessarily the case as recently as six months ago, when testing on mid-tier class models showed they struggled to complete “moderately complex” agentic tasks. Today’s middle class largely can. Their relative cheapness means users can spend many times more resources—running them repeatedly—to solve the same challenges.”
  • Cybersecurity Dive adds,
    • “Criminal and state-aligned threat groups are testing frontier and open-weight AI models to develop new methods of attacking corporate IT networks. 
    • “Attackers are using AI for a range of activities, enabling them to develop new exploits, accelerate attack speeds and maintain persistence through the abuse of legitimate tools, researchers from Accenture and Google Cloud said during a media presentation at the Black Hat USA conference in Las Vegas.
  • and
    • “Criminal actors are offering a range of AI-powered hacking tools and related services for sale on underground forums on the dark web, according to a report released Wednesday by cybersecurity firm Trellix. 
    • “Researchers found a wide range of AI-based tools being sold through these markets, ranging from reconnaissance tools to credential markets, as well as AI-as-a-service platforms. 
    • “The report shows how AI is being monetized to lower the barriers of entry into sophisticated threat activity. “
  • and
    • “Security researchers are backing claims by a newly emergent data-extortion group that it has exfiltrated sensitive data from about 15 companies, governments and other organizations. 
    • “A threat group called ExfilSquad claimed on July 26 to have exfiltrated customer records and other information from a number of city governments and universities, a major public school system and private companies. After being met with skepticism, the threat actor later released samples of the allegedly stolen information. 
    • “Researchers at Fortra released a report Thursday that corroborates ExfilSquad’s breach claims. The leaked data appears to be related to misconfigured Microsoft Power Page portals, a software-as-a-service platform that is used to create public-facing business websites. The misconfiguration enabled unauthorized access to Microsoft D365, according to researchers, which led to public read access.” 
  • Per Cyberscoop,
    • “Suspected Chinese hackers used open-source artificial intelligence models to run a cyberattack against the Taiwanese government in the first publicly known case of an autonomous AI hack hitting a government target, according to research published Wednesday.
    • “The hackers extracted more than 2,500 personnel records, among other data, in the “near-autonomous attack,” researchers at Israeli cyber firm Dream wrote in a blog post. The attackers set up the framework so that it could “adapt mid-operation without human intervention.”
    • “The framework “implements dedicated research phases it calls ‘Learning Cycles’ — autonomous sessions where the AI system searches vulnerability databases, GitHub repositories, and security research publications for techniques specifically applicable to its target government’s infrastructure,” the post reads.
    • “And then it kept going.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) added three known exploited vulnerabilities to its catalog this week.
    • August 11, 2026
      • CVE-2026-20349 Cisco Secure Firewall Adaptive Security Appliance (ASA) and Firewall Threat Defense (FTD) Heap Inspection Vulnerability
      • CVE-2026-68820 Microsoft Windows Ancillary Function Driver for WinSock Use-After-Free Vulnerability
      • CVE-2026-72898 Metabase SQL Injection Vulnerability
        • Cybersecurity Dive discusses the Cisco KVE here.
        • The Hacker News discusses the Microsoft KVE here.
        • Dark Reading discusses the Metabase KVE here.
  • Cybersecurity Dive notes,
    • “The global system that catalogs technology vulnerabilities is resilient enough to survive the current onslaught of AI-generated bug reports that has alarmed cybersecurity experts, key leaders of that system said last week during panels at two security conferences here.
    • “The Common Vulnerabilities and Exposures (CVE) Program — whose unique vulnerability identifiers are the bedrock of the entire cybersecurity industry — “will find a way to scale,” Lindsey Cerkovnik, branch chief for vulnerability response and coordination at the Cybersecurity and Infrastructure Security Agency (CISA), said at the Black Hat USA conference on Thursday [August 6, 2026]. “CVE is going to continue to flourish and improve, and I feel very positively about it.”
  • Infosecurity Magazine points out,
    • “A critical-severity VMware vCenter vulnerability has been exploited within five days of disclosure by Broadcom, with attackers deploying an open-source reverse shell to hold access to compromised systems.
    • “The treat research team at German firm Quirso discovered the campaign during an incident response engagement and published its findings on August 10.
    • “The digital forensics company assessed a suspected advanced persistent threat (APT) actor was responsible, counting 361 victim IP addresses across 47 countries while cautioning that an IP address does not necessarily correspond to a single organization.
    • “The vulnerability, CVE-2026-59310, is acritical directory traversal flaw in the vCenter Syslog server rated CVSS 9.8. Broadcom said an unauthenticated attacker with network access to vCenter can exploit it to execute arbitrary code, turning a service built to collect logs into a route into the operating system.”
  • Per Cyberscoop,
    • “Delta Airlines said Tuesday [August 11] it’s investigating an incident on a Monday flight where a passenger reportedly used an unidentified device to spoof the airline’s in-flight Wi-Fi network, leading to severe delays and authorities to board the plane once it arrived at its destination.
    • “Various posts on several social media networks went viral early Tuesday detailing the incident, claiming that passengers on Delta flight 591 from Las Vegas to Atlanta used an unidentified device to create a rogue Wi-Fi network that could be used to steal people’s sensitive data or personal information.
    • “Messages from the plane’s Aircraft Communications Addressing and Reporting System (ACARS) show that the crew informed personnel on the ground that a passenger set up a network called “Delta WiFi Fast” and was “trying to scam the other passengers.”
    • “Morgan Durrant, a Delta spokesperson, told CyberScoop that the cabin crew deactivated the aircraft’s WiFi functionality for approximately 30 minutes, the flight’s safety was never in question and no aircraft operating systems were affected.” * * *
    • “The incident bears the hallmarks of an “evil twin attack,” where an attacker deploys a rogue Wi-Fi access point that masquerades as a legitimate, trusted network by cloning its name and network settings. Often paired with deauthentication attacks that forcefully disconnect devices from the real network, the fraudulent hotspot tricks nearby laptops and smartphones into automatically connecting to it instead. Once a device connects to the rogue point, an attacker can monitor unencrypted internet traffic, execute man-in-the-middle attacks, or display spoofed login portals designed to harvest sensitive user credentials and personal data.”  
  • The Wall Street Journal points out,
    • “Thousands of North Korean operatives are using fake and stolen identities to land remote jobs at U.S. companies—funneling hundreds of millions of dollars back to the regime.
    • “Leaked data, interviews and never-before-seen videos obtained by The Wall Street Journal reveal how a single team of these workers infiltrated at least eight companies in just a few months. Watch the documentary and read the practical takeaways.”

From the ransomware front,

  • Checkpoint issued its report on the State of Ransomware Q2.
  • The American Hospital Association News reports,
    • “U.S. and international agencies released a joint cybersecurity advisory Aug. 10 warning of actions by Gunra ransomware. Gunra is a ransomware-as-a-service program that has been used to target government, critical infrastructure — including healthcare — and other organizations in the U.S. and abroad.
    • Gunra actors leverage a double-extortion model, both encrypting data and threatening to publish stolen data to a dedicated leak site if a ransom is not paid. The ransomware variant initially appeared in 2025. The advisory provides details on Gunra activity and includes detection and mitigation guidance to protect organizations.”
  • Dark Reading adds,
    • “The joint advisory urged organizations to prioritize patching known exploited vulnerabilities in Internet-facing appliances such as VPNs, implement and test offline immutable backups, and implement network segmentation to limit threat actors’ ability to move laterally.”
  • The HIPAA Journal relates,
    • “AnMed has not disclosed the name of the group behind the attack, but a threat group called The Gentlemen claimed responsibility. The Gentlemen is a ransomware-as-a-service group that is thought to include affiliates and operators from other prominent ransomware groups. The group has claimed several healthcare victims in recent months, and the pace of the attacks is accelerating.
    • “According to the Industrial Ransomware Analysis from the operational technology cybersecurity company Dragos, The Gentlemen was the third most active ransomware group in Q2 2026, claiming 125 attacks in the quarter alone, up from 83 attacks in Q1 – the largest gain out of all established ransomware groups. While the group ranked third, there were only 15 attacks separating the top three ransomware groups, with no single ransomware group dominating.”
  • Bleeping Computer tells us,
    • “Oil giant Shell has confirmed it is investigating a potential security incident after the Clop ransomware gang claimed it stole 89GB of data.
    • “Shell is a British multinational energy conglomerate and one of the world’s top three oil and gas companies, after Chevron and ExxonMobil. It has 85,000 employees in more than 70 countries and operates a massive network of tens of thousands of service and recharge stations that serve over 20 million customers daily.
    • “According to a recent post on Clop’s dark web data leak site, the allegedly stolen files include engineering drawings, scans of facility testing reports, photos of the facilities, and project plans.”
  • and
    • “An Akira ransomware affiliate disabled the endpoint detection and response (EDR) solution on a compromised system by restarting the machine into Safe Mode with Networking.
    • “The attack occurred on August 4 after the hacker obtained initial access through an exposed SonicWall VPN device without multi-factor authentication (MFA).
    • “Managed detection and response (MDR) services company Huntress says that roughly two hours after a successful VPN login, the attacker connected to the domain controller via RDP, enumerated Active Directory users and computers, and then moved to an application server.”
  • and
    • “CISA confirmed today that ransomware gangs have begun abusing a high-severity Microsoft SharePoint remote code execution vulnerability, which has been flagged as actively exploited since early July.
    • “Tracked as CVE-2026-45659, this security flaw stems from a deserialization of untrusted data weakness and allows attackers with low privileges to execute arbitrary code on unpatched SharePoint servers.
    • “It can also be exploited in low-complexity attacks because (as Microsoft explained in May when it released security updates for SharePoint Enterprise Server 2016, SharePoint Server 2019, and SharePoint Server Subscription Edition) “an attacker does not require significant prior knowledge of the system and can achieve repeatable success with the payload against the vulnerable component.”
  • The Record informs us,
    • “A financially motivated threat actor linked to China is believed to be exploiting a critical vulnerability affecting widely used cybersecurity software in a supply-chain attack that could see the hackers deploy custom ransomware across a cascading list of victims’ networks. 
    • “Microsoft Threat Intelligence warned this weekend that the Storm-1175 group began deploying a new ransomware strain on August 2 called StormEncryptor. The hackers previously used the Medusa ransomware to extort healthcare, professional services and finance organizations in Australia, Britain and the United States. 
    • “Back in April, the hackers were described as operating “high-velocity ransomware campaigns” exploiting both recently disclosed vulnerabilities and zero-day exploits, “in some cases a full week before public vulnerability disclosure.” Microsoft said it had seen the group move from initial access to full encryption in under 24 hours. 
    • “In this latest campaign, Microsoft said the group is likely exploiting CVE-2026-18577 — a vulnerability in N-central, a remote monitoring and management (RMM) console used by thousands of managed service providers to administer client endpoints.”
  • The Hacker News adds,
    • “The ransomware group known as DeadLock has been observed using decentralized infrastructure to facilitate victim communications and data leak operations in a bid to improve operational resilience.
    • “Its recovery ecosystem combines the Session messaging network with blockchain-backed services that store and deliver resources used throughout the extortion process,” the Microsoft Threat Intelligence team said.
    • “The tech giant said it observed the ransomware being deployed by multiple threat actors, including an affiliate for Lynx and INC ransomware.”

From the cybersecurity business and defenses front,

  • Bloomberg reports,
    • “Anthropic PBC is telling prospective investors its second-quarter revenue jumped at least 14-fold versus the same period a year ago, according to documents seen by Bloomberg News.
    • “The Claude chatbot maker reported a preliminary revenue figure of more than $11.5 billion in its latest completed quarter, compared to $787 million in the corresponding period in 2025, and $4.73 billion in the first quarter of this year, the documents show. The second quarter of 2026 saw Anthropic report positive adjusted operating income, according to the documents.”
  • Reuters relates,
    • “Anthropic is in talks to buy Nvidia-backed startup Decart AI, according to a source familiar with ​the matter, as the Claude maker explores acquisitions that ‌could help it handle growing demand ahead of its public listing.
    • “Bloomberg News, which first reported the news on Wednesday, said a deal ​could be worth about $6 billion, citing sources.”
  • Tech Crunch adds,
    • “Anthropic will watermark text generated by its models, including Claude, to comply with European regulations, the company now says. The AI model maker confirmed the watermarking in an updated support page.” * * *
    • “It’s not clear how much editing users need to do to remove the watermark. We have asked Anthropic to clarify and will update the story if we hear back.
    • “The company noted that watermarking will apply to different products like Claude platform API, Claude, Claude Code, Claude Cowork, and Claude Tag.
    • “Platforms are now rushing to watermark AI-generated content after backlash from users and to avoid regulatory scrutiny. Last week, AI music platform Suno said it will mark tracks created on its platform after a spate of legal challenges. Last month, newsletter service Substack teamed up with Pangram to flag AI-generated content. The company’s CEO, Chris Best, called out Claudefishing, a term used for people using AI to generate content.
    • “Apart from Anthropic, other companies like Black Forest Labs, Google, Meta, Microsoft, OpenAI, and Synthesia have committed to adhering to the EU’s code.“
  • Cybersecurity Dive informs us,
    • “Cisco’s security revenue surged last quarter as the technology giant saw growing demand for products designed to protect businesses against emerging cybersecurity threats, including those enabled by artificial intelligence agents, the company reported Wednesday.
    • “The company posted $17.3 billion in total revenue for its fiscal 2026 fourth quarter ended July 25, a year-over-year increase of 18%. Security revenue rose 14% in the quarter to $2.2 billion from a year earlier.
    • “The rise of agentic AI is expanding the threat landscape, driving demand for our security and observability solutions to help monitor agent behavior and mitigate evolving threats,” CEO Chuck Robbins said during a Wednesday earnings call.”
  • The Wall Street Journal notes,
    • “Enterprise users spent $300 million on quantum computing in 2025, outranking research labs and governments as the primary spenders for the first time.
    • “A Boston Consulting Group survey found that 62% of the top 25 global companies across 11 major industries spend at least $1 million annually on quantum.
    • “Companies like HSBC, Allstate and EY are investing to prepare for future commercialization and to secure systems against quantum encryption threats.”
  • Per Dark Reading,
    • “Walmart, the world’s largest retailer, faces a complex cyber threat landscape, documenting 806 reported retail breaches in Verizon’s 2026 Data Breach Investigations Report.
    • “Security leadership stresses balancing strong cybersecurity controls with business innovation and speed, avoiding operational drag that could lead staff to bypass safeguards.
    • “Walmart’s security approach involves proactive transparency and trust-building with leadership, using color-coded executive summaries and open discussions on risks and mitigation progress.
    • “Industry experts emphasize the evolving role of security operations as essential business partners, noting there is no one-size-fits-all model but a universal need for pragmatic resilience and honest communication.”
  • and
    • “The Patch Gap: Why Defenders Need to Think in Chains, Not Checklists
    • “It’s time to turn from CVSS-backed patching to choke-point patching focused on breaking chains to critical assets.”
    • “If the volume problem and prioritization problem can’t be solved by patchingfaster and scoring harder, then the framing itself needs to change. The question that the security team should ask is not “which vulnerabilities are most severe in isolation?” but rather “which vulnerabilities, if left unpatched, create a connected path from an attacker’s foothold to our most critical assets?”
  • Per a CISA announcement,
    • “This year marks the 20th year of Cyber Storm, a full-scale national cybersecurity exercise that for two decades has brought together the people who defend the systems Americans rely on. Held every two years, Cyber Storm X arrives as threats from geo-political activity, compromised edge devices, AI risks, and more present new challenges to our nation’s critical infrastructure.
    • “As the nation’s largest cybersecurity exercise, Cyber Storm plays a vital role in preparing for potential cybersecurity incidents by testing and strengthening the nation’s ability to coordinate a unified cyber response. Participants from private and public organizations work together through a simulated crisis. Together, they learn as a team and build stronger relationships that will speed response during an actual event. Importantly, organizations can also update their response plans based on lessons learned during the exercise.” * * *
    • “Learn more about Cyber Storm and past events at cisa.gov/cyber-storm. For more information about CISA’s exercise resources, visit CISA Exercises.”
       
  • Security Boulevard adds,
    • “CrowdStrike has announced a $100,000 international competition that challenges participants to manipulate live AI agents using prompt injection and other red-teaming techniques.
    • “The competition takes the form of a virtual game called AI Unlocked: Agents of Chaos, created in collaboration with Amazon Web Services. Players take on a fictional mission to stop a shadow group from deploying malicious AI. To do that, they must manipulate the group’s own agents into revealing information and taking actions they were not authorized to perform. Their scores also depend on efficiency, with points deducted for every token used in their prompts.
    • “The contest opens Aug. 31 and is divided into three acts. The first runs through Sept. 7 with a $10,000 prize, the second ends Sept. 14 and awards $20,000, and the final act runs from Sept. 15 through Sept. 29 with a $70,000 prize. The game is available online internationally, with an in-person option to play at CrowdStrike’s Fal.Con conference. Pre-registration is open, and contestants can replay completed puzzles to refine their prompts. CrowdStrike said the highest score recorded when each act closes will receive that act’s prize.”
  • Here is a link to Dark Reading’s CISO Corner.

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.” 

Thursday report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Service news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced $102 million in New Access Points awards to significantly expand the reach of the Health Center Program. The awards represent the first major expansion of the Health Center Program since the first Trump Administration in 2019, supporting 158 new and existing health centers to establish 415 new sites and expand access to comprehensive primary care for nearly 1 million people nationwide.
    • “Strong primary care prevents disease and gives Americans greater control over their health,” said HHS Secretary Robert F. Kennedy, Jr. “This $102 million investment will bring high-quality care to nearly one million more Americans, expand prevention and nutrition services, and help communities tackle chronic disease at its roots. We are giving more Americans the tools to live healthier lives and Make America Healthy Again.”
    • “Learn more about the Health Center Program and find a health center near you.
    • “Visit the New Access Points webpage for more details on the program and a list of 2026 award recipients.”
  • Per a Government Accountability Office news release about a new report,
    • “National Crisis and Support Hotlines: Contact Volume Increased and Operations Remained Relatively Consistent in 2025
    • “GAO-26-109046. Published: Aug 13, 2026
    • “The federal government operates the following hotlines:
      • “Health and Human Services’ 988 Suicide & Crisis Lifeline provides 24/7 support to people in distress
      • “HHS’s National Maternal Mental Health Hotline provides emotional support to pregnant and postpartum women
      • “Veterans Affairs’ Veterans Crisis Line provides support to veterans, service members, and their families
    • In February 2025, the President issued an executive order aimed at reducing the size of the federal workforce. While HHS and VA reduced their staff, the hotlines’ operations and services remained mostly consistent, with an increase in chats, texts, and calls.
  • FEHBlog observation: While aware of the 988 line, he wants to call attention to the other two lines.

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

  • Federal News Network reports about, “FEHB and Medicare: Understanding how they work together in retirement.”
  • Fedweek explains “How FEDVIP Differs from FEHB in Retirement.”
  • Tammy Flanagan, writing in Govexec, advises “Before you take money out of your TSP, weigh these trade-offs.”
    • “A withdrawal can affect everything from your tax bill and Medicare premiums to how long your savings last and what your heirs receive.”
  • Federal News Network tells us,
    • “Following a year of sweeping staffing reductions, the Trump administration is laying the groundwork for agencies to ramp up recruitment efforts. The Office of Personnel Management has directed agencies to begin assembling “annual staffing plans” for fiscal 2027.”
  • Chief Data Officer Magazine informs us,
    • “The U.S. Office of Personnel Management (OPM) has directed federal agencies to make technology recruitment a key component of their fiscal year 2027 workforce plans. Guidance issued by OPM directs agencies to include dedicated hiring strategies for roles in artificial intelligence (AI), cybersecurity, software engineering, data science, digital services, and other technology fields in staffing plans due by Sept. 30.
    • “Agencies are also expected to assess how the adoption of modern technologies will affect workforce needs and align hiring accordingly.”
  • Federal News Network adds,
    • “The Merit Systems Protection Board is officially transitioning away some of its authority over adverse action appeal decisions. A new final rule from MSPB removes all references to the board’s prior jurisdiction over appeals due to firings or demotions during a reduction in force, probationary period or for a suitability-related reason. The adjustments at MSPB come after the Office of Personnel Management finalized rules to take over decisions in those three categories of workplace disputes. The change takes full effect in early September.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports.
    • “Novartis is recalling a single lot of valsartan, a blood pressure drug the company sells under the brand name Diovan, due to failed dissolution specifications. This means it is not dissolving correctly, which can impact the drug’s effectiveness. 
    • “The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, meaning exposure to the drug may lead to “temporary or medically reversible adverse health consequences.” 
    • “Diovan is an angiotensin II receptor blocker used to treat hypertension and heart failure. It may also be prescribed to patients after a heart attack. This specific lot, AV5913C, includes packages of 90 160-mg tablets that expire in June 2027. The drugs were manufactured by Pantheon Manufacturing Services in Greenville, North Carolina, and distributed by Novartis Pharmaceutical Corp. in Hanover, New Jersey.”
  • Yahoo News relates,
    • “There’s an ongoing recall on a specific type of bladder medication distributed and prescribed nationwide, according to the U.S. Food and Drug Administration (FDA). This is due to an impurity issue.
    • “The medication being recalled is 25-milligram, 30-count bottles of mirabegron extended-release tablets manufactured by Zydus Lifesciences. The recalled bottles contain a lot code of “E408618,” an NDC of “70710-1159-3” and the expiration date “11/30/2026.” * * *
    • “Check your medication, and if you have the recalled product on hand, contact your pharmacy for a refund or replacement. Seek medical attention if you are experiencing any health concerns after consuming the affected pills.”
  • Reuters tells us,
    • “The U.S. FDA on Thursday approved Bristol Myers Squibb’s (BMY.N) oral combination treatment for patients ​with a rare form of blood cancer whose illness had relapsed or ‌not responded to other treatments, the health regulator said.
    • “The drug, iberdomide, with brand name Zenbexus, is given in combination with J&J’s (JNJ.N), opens new tab Darzalex and dexamethasone, a prescription medication used to reduce inflammation.” * * *
    • “The list price of Zenbexus is $29,500 ‌for ⁠a 28-day cycle, Bristol said. The company expects product availability within the coming weeks.”
  • The American Hospital Association News adds,
    • “The AHA Aug. 13 responded to a Food and Drug Administration request for input on the risks and benefits to health and safety associated with non-device software. Among its recommendations, the AHA supported the benefits of clinical decision support software and requested the FDA to permanently adopt flexibilities for CDS that generate only one clinical recommendation. The AHA also requested that the FDA clarify its general wellness guidance by providing additional resources on labeling and clarifying or removing references to allow non-device general wellness applications to make recommendations on escalation to a healthcare provider. Finally, the AHA encouraged the FDA to continue to update guidance, education and other materials to account for novel artificial intelligence applications, including generative AI. Input will support an agency report, as required under Section 3060 of the 21st Century Cures Act.”

No Surprises Act News

  • Following up on yesterday’s discussion of the U.S. Court of Appeals for the Fifth Circuit’s opinion about the calculation of qualifying payment amounts (“QPA”), the American Hospital Association tells us,
    • “A statement posted Aug. 13 on the Centers for Medicare & Medicaid Services website said that the agencies are reviewing the court’s opinion and judgement and anticipates issuing guidance shortly.” 
  • FEHBlog Observation: The Fifth Circuit is a victory for the majority of health care providers who accept the QPAs. No one can object to that outcome.
  • Beckers Hospital Review recounts “the never-ending No Surprises saga.”
    • “When President Trump signed the No Surprises Act into law in 2020, the straightforward premise was that patients should not be blindsided by massive emergency care bills from out-of-network physicians they never chose. On that front, the law has largely worked. 
    • “But the system Congress built to resolve payment disputes between insurers and providers has led to an increasingly expensive and bitter standoff that insurers say is driving up premiums, while physicians report waiting months to get paid. And employers, particularly the self-funded plans that cover the majority of commercially insured workers, say they’re the ones now stuck with a big chunk of the bill. In recent months, the courts, Congress and federal regulators have all been moving in different directions on exactly what to do about it.”

From the judicial front,

  • Beckers Hospital Review reports,
    • “The federal government has referred dozens of hospitals, pharmacy benefit managers and pharmacies to investigators over potentially fraudulent billing related to pediatric gender-affirming care.
    • “Vice President JD Vance referred hospitals and clinics identified in a new HHS report to the Justice Department, while HHS Secretary Robert F. Kennedy Jr. referred flagged organizations to HHS’ Office of Inspector General over “potentially anomalous billing patterns” identified through an analysis of insurance claims, according to an Aug. 13 news release.” * * *
    • “In the report, HHS shared its analysis of claims data spanning 2015 to 2025, identifying $47.6 million in claims for puberty-blocking drugs prescribed to patients 9 to 17 years old with endocrine disorder diagnoses, excluding precocious puberty. The patients also did not have a gender-related diagnosis documented. Of those claims, $42.6 million stemmed from an unspecified endocrine disorder diagnosis, the report said.” * * *
    • “The referrals mark the latest escalation in a federal crackdown on pediatric gender-affirming care that began shortly after President Donald Trump returned to office in January 2025. Some pediatric hospitals, most recently Hartford-based Connecticut Children’s Medical Center, have struck deals with the Justice Department and stopped providing gender-affirming care services.”
       
  • The Wall Street Journal relates,
    • “Luigi Mangione is expected to plead guilty Friday in a Manhattan federal court, where he is facing stalking charges in connection with the killing of UnitedHealthcare CEO Brian Thompson outside a Midtown hotel in 2024, people familiar with the matter said.
    • “The expected plea potentially resolves the federal case just a month before Mangione is scheduled to go to trial in New York state court on murder and other charges. But the people familiar with the matter cautioned that Mangione still could change his mind. And his defense team has abruptly shifted strategies previously.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Arthritis in its many manifestations is among the most common chronic conditions, affecting some 53 million adult Americans, and its associated pain often impairs the ability to perform daily activities including work.
    • “The Healthy People 2030 initiative set a goal of reducing the prevalence of joint pain in the U.S. to about 52%.
    • “In this analysis of National Health Interview Survey data from 2023, moderate to severe joint pain was reported by 58% of those with arthritis, with no change from 2019 (57%) after adjusting for age distribution.”
  • and
    • “Estrogen-only menopausal hormone therapy was linked with reduced Alzheimer’s pathology in an autopsy study.
    • “Estrogen treatment was also tied to lower odds of dementia diagnosis.
    • “More than 20 years after the landmark Women’s Health Initiative trial, hormone replacement therapy remains controversial.”
  • Beckers Behavioral Health relates,
    • “A nationwide, evidence-based tobacco treatment program for cancer patients and survivors in the U.S. would save $12.32 billion in healthcare costs over 10 years, according to a study published July 14 in JCO Oncology Practice.
    • “Led by researchers from Houston-based University of Texas MD Anderson Cancer Center, the study projected 10-year survival trends and healthcare cost savings associated with a nationwide smoking cessation program targeted to 18 million U.S. cancer survivors.” * * *
    • “Read the full study here.” 
  • Healio adds,
    • “Exercise capacity, oxygen uptake and ventilation at peak exercise were significantly reduced in e-cigarette and conventional cigarette users vs. never smokers.
    • “Vascular function also followed this pattern.”
  • BioPharma Dive lets us know,
    • “Taiho Oncology and partner Cullinan Therapeutics said a targeted medicine they’re developing has succeeded in a Phase 3 trial in frontline lung cancer, with investigators halting the study at an early data check because of clearly positive results.
    • “Taiho and Cullinan have been testing that therapy, zipalertinib, alongside chemotherapy in the first-line setting in people whose lung tumors have a so-called exon 20 insertion in a gene called EGFR. They didn’t release detailed data, but on Wednesday said that the combination “demonstrated a statistically significant and clinically meaningful improvement” in progression-free survival, meeting a pre-planned threshold for unblinding the trial.
    • “The Food and Drug Administration is already reviewing zipalertinib as a second-line treatment and is expected to make a decision by Feb. 27. If approved, the drug will add to an already competitive market battle. Johnson & Johnson’s Rybrevant and AstraZeneca and Dizal’s Zegfrovy are both available, and another biotechnology company, ArriVent BioPharma, is expecting Phase 3 data later this year.”
  • and
    • “Boulevard Bio, a new startup co-founded by pioneering autoimmune disease researcher Georg Schett, officially launched Wednesday with $65 million in its coffers and three experimental drugs.
    • “One of those medicines is already in early testing. Called BLVD-101, that drug is a so-called bispecific antibody aimed at a pair of targets known to drive the progressive kidney condition IgA nephropathy.
    • “IgAN has become a popular target for drugmakers of late. In the last year, U.S. regulators have approved two drugs, Vera Therapeutics’ Trutakna and Otsuka Pharmaceutical’s Voyxact. A third from Vertex Pharmaceuticals could follow.”
  • Fierce Pharma notes,
    • “Roughly a year and a half after the approval of Vykat XR, a group of clinicians with deep ties to the Prader-Willi syndrome (PWS) community is flagging potential safety concerns about the rare disease med, acquired in Neurocrine’s $2.9 billion buyout of Soleno Therapeutics last spring.
    • “The package insert for Vykat XR (diazoxide choline)—a potassium channel activator that became the first drug approved to treat the sensation of insatiable hunger, or hyperphagia, in PWS in March 2025—already cites the risk of fluid overload, based on an increased incidence of edema seen during clinical trials. 
    • “Since becoming more widely available, additional reports of edema and related complications in patients taking Vykat XR have been posted to the FDA’s Adverse Event Monitoring System (AEMS), including seven reports of death and more than 100 other reports of serious adverse events, mostly tied to edema, respiratory and cardiac complications.
    • “The adverse event trend, which doesn’t establish that Vykat XR caused the events, was flagged in a statement (PDF) from PWS patient organizations the Foundation for Prader-Willi Research, the International Prader-Willi Syndrome Organization and Prader-Willi Syndrome USA. The issue was first reported by Stat News earlier on Wednesday.” 

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

  • The American Hospital Association News reports,
    • “A blog by Robyn Tessin, AHA director of policy, discusses the ways value-based care can meet patients’ needs, resulting in improved affordability and access to timely, coordinated care. “The promise of value-based care is a healthcare system that feels less like a collection of separate transactions and more like a connected journey centered on each patient,” Tessin writes. “No single payment model can solve every affordability challenge. But providers, policymakers, payers and patients can build on what is working — strengthening existing models such as [accountable care organizations], scaling innovations in care coordination and ensuring that the models’ financial incentives are meaningful for patients.” READ MORE 
  • Beckers Payer Issues adds,
    • “Mishawaka, Ind.-based Franciscan Alliance has partnered with Millennium Physician Group to expand value-based care and primary care access across Indiana.
    • “Fort Myers, Fla.-based Millennium is part of a national value-based care platform partially owned by Elevance Health.
    • “The partnership will combine Franciscan’s physician network with Millennium’s practice management, analytics and value-based care capabilities. Franciscan physicians will remain part of the health system’s physician network while gaining access to additional operational support, technology, care coordination resources and analytics.
    • “As Franciscan Alliance celebrates 150 years of serving Indiana, this partnership represents the next chapter in that mission,” Franciscan Alliance President and CEO Kevin Leahy said in an Aug. 12 news release. “By combining our trusted community presence with Millennium’s proven expertise in value-based care, we are strengthening our ability to expand access, enhance quality and deliver more affordable healthcare for generations to come.
    • “The organizations said the partnership is designed to reduce administrative burdens for physicians, improve clinical performance and strengthen chronic disease management and care coordination.”
  • Reuters relates,
    • “Novo Nordisk (NOVOb.CO) CEO Mike Doustdar said investors are underestimating the demand for differentiation among obesity drugs, ‌and that new treatment options like pills will keep it from becoming a winner-take-all battle with rival Eli Lilly.
    • “Novo was first to bring a highly effective GLP-1 weight-loss injection, Wegovy, to the U.S. market, but is under pressure to regain ground lost to Lilly’s (LLY.N) Zepbound in a business that ​analysts expect will be worth more than $100 billion a year by 2030.
    • “Doustdar, who took the helm at the Danish ​drugmaker a year ago, said that patients are just beginning to understand which GLP-1 drug is ⁠best suited to them, and he expects more segmentation as new medicines are approved. More than 100 million U.S. adults ​are classified as obese.
    • “Right now the investor community has thought this is supposed to be a zero-sum game between two players – ​there’s a loser and a winner,” Doustdar said in an interview with Reuters on Wednesday.
    • “As you foresee the future of GLP-1s and obesity and weight-loss drugs, it will not be Coke versus Pepsi. It will be Coke and Pepsi and Fanta and Dr Pepper and Red Bull. People are ​thirsty, and they can make their choices,” he said.”
  • Beckers ASC Review tells us,
    • “For much of the past decade, the story of physicians’ practice has moved decidedly away from independence. 
    • “Hospital and corporate employment of physicians climbed from 62% to 78% between 2019 and 2023, and private practice fell from 60% of physicians in 2012 to just 42% in 2024, according to data from the Government Accountability Office.
    • “But 2026 is producing early signs that the pendulum may be swinging back, not toward the traditional solo practitioner model, but toward a new one built around management services organizations, physician practice networks and other arrangements designed to help physicians reclaim ownership and autonomy without giving up the scale and capital that made employment attractive in the first place.”
  • Healthcare Dive informs us,
    • “Nonprofit hospitals and health systems rated by credit ratings agency Fitch raised their operating margins and extended their financial recovery last year, according to a Fitch Ratings report based on audited fiscal 2025 data.
    • “The median operating margin among 222 nonprofit providers rose to 1.5%, compared to 1.1% in 2024, according to the report, and gains were increasingly concentrated among more financially stable providers. 
    • “Still, Fitch warned that 2025 could prove to be an “operational peak” before Medicaid funding reductions and other policy changes begin to pressure hospital revenue more significantly in 2027. Financially unstable and Medicaid-dependent providers have less financial cushion to absorb the coming strain, according to the credit ratings agency.”
  • Fierce Healthcare points out,
    • “Aetna is seeing its value-based care efforts pay off in both preventive care metrics and cost savings, according to a new analysis from the company.
    • “The insurer compared (PDF) outcomes across 20 different measures for individuals in its Medicare Advantage plans between value-based models and fee-for-service, and found that the value-based arrangements supported better results across 17 of the included measures.
    • “For example, value-based care models far outpaced fee-for-service in managing blood sugar and high blood pressure. Under value-based care, 43% more members controlled their HbA1C and 34% had controlled blood pressure, according to the analysis.
    • “In addition, 20% more patients were screened for colorectal cancer under value-based care and there were 7% fewer hospitalizations. These providers also generated $315 million in savings during plan year 2023, 2.6% higher than fee-for-service providers.”
  • and
    • “Cedar, a patient financial platform for healthcare providers, launched an agentic artificial intelligence platform Thursday aimed at patient medical billing.
    • “Kora Platform is a suite of purpose-built AI agents that integrates with healthcare organizations’ existing electronic health records (EHRs), telephony and call center systems. Some of the capabilities included within the suite include autonomous inbound voice, autonomous outbound voice, two-way text and advanced reporting.
    • “We really want Kora Platform to be this agentic advocate that’s sitting in the pocket of every patient,” Cedar Chief Strategy Officer Dugan Winkie told Fierce Healthcare.”
  • The American Medical Association lets us know about “four AI prompts to help prepare for your doctor’s appointment.”
    • “Here are some top expert tips on how to use AI chatbots in a way that makes the most of your time in the exam room with your physician.”

Midweek update

David Ermer–Agentic & Generative AI, AHRQ, CDC, CMS, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a $4 million initiative to expand access to rapid, point-of-care syphilis testing, with a focus on reaching women in emergency departments and other nontraditional healthcare settings.
    • “Congenital syphilis is preventable, yet too many mothers and babies are still suffering its devastating consequences,” said HHS Secretary Robert F. Kennedy Jr. “HHS is putting rapid tests where women receive care so we can detect infections earlier, treat them faster, and protect more babies.”
  • Beckers Behavioral Health adds,
    • “HHS Secretary Robert F. Kennedy Jr., White House Office of National Drug Control Policy Director Sara Carter, and Housing and Urban Development Secretary Scott Turner released a toolkit Aug. 12 focused on addressing homelessness and addiction through treatment.
    • “The “Best Practices Toolkit: Addressing Homelessness and Addiction Through Treatment First” outlines strategies for communities to “help Americans transition from homelessness and addiction to recovery and self-sufficiency,” according to an Aug. 12 news release from HHS.
    • “The toolkit centers on a “Treatment First” model, which prioritizes coordinated and accountability-driven engagement in evidence-based treatment and recovery support services. It supports drug treatment and recovery efforts through the Great American Recovery Initiative.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services today released an advisory for certain clinicians who are qualifying alternative payment model participants and eligible to receive APM incentive payments, notifying them that their current billing information must be updated to receive funds for the 2026 payment year. CMS said that it was unable to identify a taxpayer identification number associated with some participants after processing 2026 APM incentive payments and therefore was unable to disburse payments. The agency said that all information must be received by Oct. 13. Following that date, CMS said any claim to an APM incentive payment for the 2026 payment period based on an eligible clinician’s qualifying APM participant status for the 2024 performance period will be forfeited.” 
  • Beckers Hospital Review adds,
    • “Participation in mandatory value-based payment programs from CMS is associated with significantly higher annual administrative costs for hospitals, according to a study published Aug. 7 in JAMA Health Forum.
    • “Researchers at the Brown University School of Public Health in Providence, R.I., examined 2006 to 2020 Medicare cost report data for 4,332 hospitals, including 2,820 that participated in the Hospital Value-Based Purchasing program, Hospital Readmissions Reduction Program and Hospital-Acquired Condition Reduction Program. They also assessed costs associated with participation in the Comprehensive Care for Joint Replacement model. * * *
    • “Participation in the first three programs was tied to annual administrative cost increases ranging from $650,000 per hospital compared with long-term acute care hospitals to $1.23 million compared with general acute care hospitals in Maryland. Participation in the CJR model was linked to a $1.4 million annual increase in administrative costs per hospital.
    • “Aggregated nationally, the programs accounted for more than $3 billion in additional annual administrative spending.”
  • Beckers Clinical Leadership tells us,
    • “HHS is creating a new pathway to evaluate which conditions should be added to the national newborn screening panel as part of a broader effort to modernize a review process that officials say has lagged behind advances in genetic medicine.
    • “The Health Resources and Services Administration on Aug. 11 launched a framework to streamline evidence reviews for the Recommended Uniform Screening Panel, the federal guideline nearly all state newborn screening programs follow. 
    • :A Federal Register notice published Aug. 12 laid out the mechanism: a National Newborn Screening Stakeholder Workgroup funded through a $700,000 award to the Silver Spring, Md.-based Association of Public Health Laboratories.”

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

  • My Federal Retirement reports,
    • “Based on CPI-W data through July 2026, the trend toward an estimated 2027 COLA holds at 3.1% for Social Security and CSRS retirees, which would translate to a FERS COLA of approximately 2.1% once the FERS reduction formula is applied — unchanged from last month’s estimate. The official 2027 COLA won’t be announced by the Social Security Administration until mid-October 2026. This page is updated monthly as new CPI-W data is released.”

From the Food and Drug Adminstration front,

  • The Hill reports,
    • The Food and Drug Administration (FDA) is assuring Americans that they should feel confident eating fresh produce again, seeking to ease concerns over the nation’s food supply after a cyclospora outbreak linked to iceberg lettuce spread across more than a dozen states.
    • “We have the safest food supply in the world,” acting FDA Commissioner Kyle Diamantas said in a Tuesday interview with CNBC. “Americans should feel confident in eating fresh produce including leafy greens at this point.
    • “Diamantas added that his agency “remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market” since California-based vegetable producer Taylor Farms voluntarily recalled products linked to the outbreak on July 17.” * * *
    • “The FDA and CDC are still investigating the outbreak, and officials have warned that the number of confirmed illnesses could continue to climb long after the recall because it can take as long as six weeks to determine whether an illness is connected to the outbreak.”
  • Medscape relates,
    • “Following unprecedented results from the RASolute 302 trial, cancer centers across the US are making daraxonrasib available to patients ahead of FDA approval.
    • “The RAS inhibitor has been in the news since it was shown to nearly double median overall survival vs standard chemotherapy — from 6.7 to 13.2 months — among patients with previously treated metastatic pancreatic cancer.
    • “The survival gain, in a notoriously difficult-to-treat disease, earned a standing ovation when the data were presented at this year’s American Society of Clinical Oncology annual meeting. And on July 22, daraxonrasib’s maker Revolution Medicines, announced that the FDA had accepted its approval application.”
  • Beckers Hospital Review tells us,
    • “San Francisco-based Hims & Hers plans to start selling compounded peptides by the end of 2026, with six more to follow pending final FDA rulemaking, executives said Aug. 10.
    • “The direct-to-consumer telehealth company laid out a phased rollout on its second-quarter earnings call. Executives said they expect to offer a first group of already-permitted peptides — including sermorelin, glutathione and a product it markets as MEDplus — by year’s end, then expand to six wellness peptides an FDA advisory committee recommended in July.
    • “We are currently developing a best-in-class peptide experience including U.S.-manufactured products, clinical-led guidance and ongoing blood testing,” co-founder and CEO Andrew Dudum said. He said the company is “waiting on full and final rulemaking from the FDA” before launching the recommended peptides.”

From the judicial front,

  • Bloomberg Law reports,
    • “The full Fifth Circuit partly struck down a series of federal rules on surprise medical bills, concerning the qualifying payment amount, or median in-network rate. 
    • “The court overturned a provision allowing insurers to include “ghost rates” in the QPA, and rejected a provision excluding bonuses and case-specific rates from the QPA. 
    • “The court sided with the agencies on a provision excluding one-time, case-specific agreements from the QPA calculation, saying the word rate “connotes a per-unit price for multiple units.”
  • Beckers Hospital Review adds,
    • “The court said the agencies can use their enforcement discretion to let insurers keep using existing QPAs while new calculations are completed, preserving balance billing protections for patients in the interim.”
  • The Wall Street Journal relates,
    • “Eli Lilly filed six lawsuits against U.S. entities it alleges are selling a version of its investigational weight-loss drug on the black market.
    • “The lawsuits claim the entities sell retatrutide, a GLP-1 drug that is still in trials and not yet approved by the FDA.
    • “Eli Lilly is calling on social media platforms and payment processors to help stop the black market sales of the drug.”

From the NCQA front,

  • The Cotiviti Blog tells us,
    • “Many health plans wrapped up Measurement Year (MY) 2025 with a smoother HEDIS® season than ever before. The organizations that performed best weren’t necessarily those with the largest teams or budgets—they were the ones with integrated data, aligned workflows, and the ability to identify and act on quality opportunities earlier.
    • For many health plans, MY 2025 brought an unexpected outcome: fewer fire drills. The most successful organizations relied on repeatable steps focused on:
      • Integrated clinical and quality data
      • Aligned teams around clear priorities
      • Chart review productivity reporting
      • Population-level measures dashboards
    • Established repeatable workflows that reduced operational friction throughout the season
    • High-achieving plans started by identifying the right opportunities by using HEDIS logic and integrated data sources to pinpoint the gaps that matter most. Effective approaches centered on opportunities where both impact and intervention are possible, targeting outreach at the provider, care manager, or member level depending on where change can occur most effectively.
    • Next, operationalizing those insights was key during MY 2025. Analytics may reveal performance gaps, but improvement happens when those findings are embedded directly into workflows. Plans that consistently outperform their peers translate data into outreach campaigns, care management activities, and provider engagement efforts with clearly defined accountability.
    • Standardization is equally important. Quality initiatives only create value when the work performed is accurately reflected in reporting. Aligning documentation and coding practices with NCQA-approved value sets helps ensure that quality improvements appear in measure results.
    • Finally, leading health plans embrace continuous measurement. They evaluate intervention effectiveness, monitor gap closure rates, assess outcomes, and create feedback loops that help refine future strategies. Over time, this transforms quality programs from a series of one-off campaigns into a scalable operating model built around continuous improvement.

From the public health and medical / Rx research front,

  • MedPage Today tells us,
    • “Wait times are increasing between cancer diagnosis and the start of first-course therapy for six cancer types, according to a retrospective cohort study.
    • “Predictors of longer wait times included Medicaid insurance, lowest-quartile income, Black race, increased travel distance, and treatment at academic institutions, among other factors.
    • “These results should be considered in the context of previous research linking treatment delays with worse survival outcomes, researchers said.”
  • Beckers Hospital Review notes,
    • “Ascension Saint Thomas in Nashville has rescheduled some elective surgeries and said it could be forced to cancel or delay additional cases because of shortages of blood products.
    • “Platelets are a particular concern at Saint Thomas, according to an Aug. 6 news release from the hospital, which is part of the St. Louis-based Ascension health system. Chief Clinical Officer Brian Wilcox, MD, told NBC News affiliate WNKY that the shortage is affecting hospitals nationwide as donations of blood products have fallen to a four-year summer low even as demand for transfusions holds steady.
    • :The disruption comes as the American Red Cross declared its second national blood crisis in history July 27, with type O blood critically scarce and distributions to hospitals now limited. The shortage began building in May, when a gap widened between the amount of blood hospitals need and the amount being donated. The Red Cross is currently sending hospitals roughly 3,500 more units of blood per week than expected.
    • “An Illinois Red Cross spokesperson told NBC News affiliate WGEM that without a constant blood supply, hospitals could be forced into situations where doctors have to choose who gets blood and who doesn’t, adding that elective surgeries that need transfusions may have to be postponed.”
  • Cardiovascular Business adds,
    • “Clinicians should pay close attention to any incidental lung findings identified when transcatheter aortic valve replacement (TAVR) patients undergo preprocedural CT scans. That is according to new findings published in Heart Lung, a journal from the American Association of Heart Failure Nurses.[1]
    • “Over the past decade, TAVR has transformed the therapeutic landscape of symptomatic severe aortic stenosis (AS),” wrote first author Mustafa Mousa Basha, MD, a researcher with University Hospital Bonn in Germany, and colleagues. “Pulmonary diseases are frequently co-existent in AS patients, often ranging from mild restriction to a mixed restrictive and obstructive pattern, and represent an important risk factor for postoperative complications following TAVR.”
  • STAT News relates,
    • “Not long after guidelines shifted to considering statin therapy as early as age 30, new research from France suggests there may be no harm in stopping the cholesterol-lowering drugs at age 75 in people with no history of cardiovascular disease. The lessons, however, may not translate elsewhere. 
    • “The “non-inferiority” study, published Tuesday in the Lancet Healthy Longevity, does not advise doctors to tear up statin prescriptions for older people. Nor does it conclude that going off statin therapy is better than staying on. It does say patients should talk to their doctors to see if they’d be no worse off for dropping the daily pills.
    • “Invoking patient choice, the authors highlight the lack of scientific literature on older people, noting what research does exist has found the link between cholesterol and cardiovascular events weakens with age. They believe their own study needs to be repeated for a longer period of time and extended to populations at higher cardiovascular risk or otherwise not as healthy as their participants.
    • “For the majority of American patients over the age of 75, this trial will not change anything,” Romit Bhattacharya, a general and preventive cardiologist from the Mass General Brigham Heart and Vascular Institute, told STAT in an interview. He was not involved in the research. “It does give us a little bit of permission and greater flexibility and choice for our individuals who maybe have a short time horizon to live and who are already quite healthy and engaged in care.”
  • The New York Times reports,
    • “President Trump issued an executive order this week calling for immunizations for measles, mumps and rubella, a mainstay of vaccination programs worldwide, to be offered as three individual jabs given at separate times, instead of in one combination shot.
    • “In an Oval Office signing ceremony, the president made a frightening and unsubstantiated claim about the combination shot. “Together, there could be a possibility they’re quite lethal.” 
    • “Researchers have not linked the combination M.M.R. shot to a risk of death, and there is no evidence that it is dangerous or that splitting it into its three components is any safer or more effective, vaccine experts said. Combination shots for the diseases have been used in the United States since 1971, and were introduced only after careful comparison against individual shots. They have been given to hundreds of millions of children.
    • “What’s more, separate vaccines for measles, mumps or rubella have not been available in the United States for many years. Vaccine manufacturers said it would take a minimum of five to 10 years for them to be tested and made available.”
  • Health Day informs us,
    • “Restarting obesity medications, including glucagon-like peptide-1 (GLP-1) receptor agonists, soon after sleeve gastrectomy (SG) surgery is associated with greater one-year weight loss than surgery alone in adolescents, according to a research letter published online July 22 in JAMA Surgery.”
  • and
    • “The 4C meningococcal B (MenB) vaccine confers modest protection against gonorrhea among adolescents, according to a study published online Aug. 4 in Open Forum Infectious Diseases.”
  • Genetic Engineering and Biotechnology News points out,
    • :A multi-disciplinary, multi-institutional group of researchers said they relied on their expertise in genetics, mechanics, chemistry, and biology to create a chip the size of a postage stamp to model a particular class of heart conditions.
    • “The team, led by Guang Li, PhD, an associate professor in the University of Pittsburgh School of Medicine’s department of cell biology, has grown heart valves on organoids. The study “Human iPSC-derived heart valve-like assembloids model valve development and disease pathology” appears in Cell Stem Cell and is an important step toward better understanding and treating a number of serious heart disorders, according to the scientists.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of baxdrostat (Baxfendy™, AstraZeneca) and lorundrostat (Mineralys Therapeutics, Inc.) for hypertension.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.” * * *
    • The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on September 9, 2026.

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

  • The Austin American-Statesman reports,
    • “On Wednesday, the University of Texas System Board of Regents’ Facilities Planning and Construction Committee will adopt a timeline and budget for phase one of the much-awaited artificial intelligence-native hospital, UT Dell Medical Center. 
    • “Construction on the $5 billion hospital is expected to begin this fall, and initial site preparation could begin within a month after board approval of this first phase, which does not include the actual building but includes design and site preparation as well as equipment that takes time to arrive such as MRIs. The committee’s agenda includes information such as a timeline and the cost of the project, which has not yet been disclosed publicly. 
    • “The hospital will include both specialty care and an MD Anderson Cancer Center Central Texas location. UT announced the project in 2023 as a $2.5 billion investment to expand access to high-quality healthcare for Central Texas and bring thousands of jobs to Austin, but when a new site chosen and the hospitals were combined into one, the price tag went up to an estimated $5 billion.” 
  • Modern Healthcare relates,
    • “Intermountain Health and AdventHealth have signed a definitive agreement to merge services at multiple hospitals, clinics and medical practices through a joint venture in the Denver area. 
    • “The deal is slated to close in early 2027, pending regulatory approval, according to a Wednesday notice from AdventHealth. The organizations signed the definitive agreement last week.
    • “Financial terms were not disclosed.”
  • KFF Health News explains how “Hospital Prepayment Requirements Add New Wrinkles to Patients’ Financial Responsibility.”
  • Beckers Health IT tells us,
    • “Bethlehem, Pa.-based St. Luke’s University Health Network and UnitedHealthcare have automated claim status updates for 88% of the claims exchanged between the two organizations, using Epic’s Payer Platform, according to Epic’s newly released 2026-2027 Almanac.
    • “The two organizations turned on Epic’s Claim Status feature to give St. Luke’s staff real-time visibility into where claims stand with UnitedHealthcare, replacing manual status checks that previously required calling the payer or logging into external portals. Brian Burd, IT director at St. Luke’s, said the health system’s main motivation was to improve revenue cycle efficiency by reducing manual claim status inquiries and speeding up follow-ups.
    • “UnitedHealthcare manages most of its claims operations outside Epic, so the insurer routes claim data through its own Epic environment first, then delivers it to St. Luke’s through the Payer Platform connection. That setup avoided the time and transaction fees of building a separate direct link between the two systems.
    • “Since the feature went live, UnitedHealthcare has seen a 25% drop in claim status calls from St. Luke’s, while St. Luke’s staff have shifted their time from chasing payer updates to higher-value revenue cycle work.”
  • Beckers ASC Review informs us,
    • “There comes a point when health system’s ASC moves stop being a side project and start requiring a more involved strategy, and, according to Atlas Healthcare Partners CEO Aric Burke it’s when revenue is above roughly $2 billion to $3 billion, and a portfolio has grown past about five centers.
    • “I think health systems over two to three billion in revenue probably need to have a real, dedicated ASC strategy,” Mr. Burke told Becker’s.”
  • and 
    • “Anesthesia has become one of the most persistent staffing headaches for ASCs and hospitals alike.
    • “It’s not just a bad labor market, but a pipeline problem stacked on top of an aging workforce, a bottlenecked training system and a reimbursement environment that’s making it harder to attract new anesthesiologists and certified registered nurse anesthetists into the specialty.”
  • and
    • “GI procedure demand keeps climbing while Medicare keeps cutting what it pays for the exact setting where those procedures are cheapest to perform.”
  • Beckers Hospital Review notes,
    • “U.S. News & World Report released its debut ratings Aug. 12 for the best GLP-1 telehealth platforms, its first evaluation of the online companies prescribing brand-name weight loss drugs.
    • “The media company rated 20 platforms offering FDA-approved, brand-name GLP-1 medications, including Wegovy, Zepbound, Ozempic and Foundayo, according to an Aug. 12 news release. Companies that offer only compounded GLP-1s were excluded, and for platforms selling both, U.S. News evaluated only the branded portion of the business.”
    • Here are the top five:
      • “Amazon One Medical: 4.8
      • “Found: 4.6
      • “Mochi Health: 4.4
      • “Ro: 4.4
      • “Noom: 4.3”
  • MedTech Dive lets us know,
    • “Abbott and Google plan to pair Abbott’s over-the-counter glucose sensor with Google’s artificial intelligence and consumer technology, the companies said Tuesday.
    • “The multiyear partnership is focused on making metabolic insights from Abbott’s device easier to use, helping people proactively manage their health. 
    • “The two companies plan to launch a large study that could inform Google’s AI health coaching and future features for Abbott’s Lingo sensor. Abbott did not disclose how many people they plan to enroll in the study.”

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.

Monday report

David Ermer–Uncategorized–

Simplicity is a virture.

From Washington, DC,

  • The American Hospital Association News reports
    • “The Senate’s budget resolution to set up a third reconciliation bill was released Aug. 7 by Sen. Ron Johnson, R-Wis., chairman of the Senate Budget Committee. It instructs 11 Senate committees to provide up to $150 billion in funding by Sept. 11. No healthcare committees received instructions. The House passed its budget resolution July 21. That version instructs the House committees on Administration, Agriculture, Armed Services and Intelligence to draft legislation that provides up to $95 billion in funding by Sept. 11.
    • “Legislators continue to focus their efforts on a reconciliation bill that would narrowly provide additional funding for defense, farm aid and election-related provisions. The House and Senate must pass an identical budget resolution before moving forward with a reconciliation bill. Additional legislative activity is expected in September when Congress returns to session.” 
  • The Wall Street Journal relates,
    • “President Trump signed a new executive order Monday calling for most children to receive fewer vaccines and made some of his most extensive comments yet linking childhood shots and autism—a connection that scientists have said is unfounded.
    • “The document Trump signed Monday is similar to a previous executive order to decrease the number of vaccines children receive. It also urges parents to spread out vaccines in more visits to pediatricians’ offices and encourages states to mandate fewer vaccines for school attendance. It calls for the measles, mumps and rubella vaccination to be given in separate shots rather than the combination shot commonly given in the U.S.
    • “The new executive order goes further than the prior effort by grouping vaccines into three buckets: those recommended for all children, those recommended only for high-risk children and those that are subject to “shared-decision making,” in which parents and doctors discuss risks and benefits for each child. Included in the final category are vaccines for Covid-19, the flu, hepatitis B and more.
    • “The order doesn’t explicitly link vaccines to autism, but the president did so in his remarks Monday at an Oval Office event.” * * *
    • “The order calls on Kennedy and a newly revived vaccine task force to, in the next 90 days, come up with new recommendations for the timing and sequencing of childhood vaccines and find alternatives to a common vaccine ingredient, aluminum. A study of more than one million children in Denmark last year found no link between aluminum in vaccines and childhood chronic diseases, but Kennedy denounced the study. Scientists have said children are exposed to more aluminum from daily life than they receive in vaccines.”
  • and
    • “The Trump administration took a partial step Monday toward Health Secretary Robert F. Kennedy Jr. promised food-system overhaul.
    • “Here’s what to know:
      • “Kennedy’s health department is asking food companies for more information about the substances they are putting into the U.S. food supply.” * * *
      • “The new proposed rule falls short of what some food-safety advocates have hoped for. Acting Food and Drug Administration Commissioner Kyle Diamantas said the notifications for new substances are mandatory, but it was unclear how the government will enforce the requirement. Food suppliers can still put new ingredients on the market before they notify regulators, Diamantas said.” * * *
      • “Health officials said stronger regulation—such as blocking companies from going to market before the FDA signs off on the safety of their ingredients—would require congressional action.” * * *
      • “Kennedy blames ultraprocessed food for many of America’s health woes, and in February promised to release a definition of ultraprocessed food by April. Such a move would allow the FDA to craft labeling rules based on the definition, he said. 
      • “The health department was widely expected to release the definition on Monday, but health officials said the draft was still being reviewed by other agencies.” 
  • Govexec tells us,
    • “The largely self-funded Postal Service is asking for “modest” annual funding from Congress, at least in the short term, to help the agency pay its bills. 
    • “USPS told lawmakers that it would run out of cash in early 2027, if it kept meeting all of its financial obligations. But the agency now expects to avoid a cash crisis for another few years by suspending its contributions to one of its employee retirement plans. 
    • “Agency leaders warn these extraordinary measures are just buying USPS more time to deal with what they consider a broken business model. 
    • “Postmaster General David Steiner said last Friday that USPS will seek a “relatively modest appropriation” from Congress, adding that those funds would “create a large return for the American economy.” 

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

  • An OPM news release offers a transcript of (OPM Director Scott Kupor[‘s conversation during] Greg Kelly Reports on Newsmax to discuss the Trump Administration’s efforts to restore merit-based hiring and strengthen accountability across the federal workforce.

From the Food and Drug Administration front,

  • The New York Times reports,
    • “Taylor Farms, which has been linked to a large outbreak of cyclosporiasis associated with iceberg lettuce in the United States, said on Sunday that it was voluntarily recalling several of its products made with fresh jalapeños that have been tied to a multistate salmonella outbreak.
    • “The recalled products include spicy guacamole, mango pico de gallo, taco dip and more than a dozen other Taylor Farms branded and unbranded products, the company said in a statement on its website. They were distributed across 26 states to major retailers — including Whole Foods, Trader Joe’s, Hannaford and Kroger’s — and have a “Best If Used By” date up to and including Aug. 16, 2026.”
  • STAT News relates,
    • “The Food and Drug Administration has rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor for Novartis. 
    • “The drug, ITM-11, had been developed by ITM Isotope Technologies Munich SE, a long-standing player in the field. Radiopharmaceuticals are an emerging type of treatment designed to shoot radioactive isotopes directly at tumor cells.” * * *
    • “ITM has more than a dozen drugs lined up behind ITM-11, for glioblastomas, renal cell carcinoma, as well as prostate and ovarian cancers.
    • “The company plans to resubmit the ITM-11 application. “Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL,” CEO Andrew Cavey said in a statement.” 
  • and
    • “Sanofi is experiencing shortages of two medicines used to treat Pompe disease, and the problem emerged shortly after the Food and Drug Administration warned the company over manufacturing issues at the Irish facility where the drugs are made.
    • “In recent days, the drugmaker has alerted patient groups and physicians in both the U.S. and Europe that supplies of Myozyme, an older standard of care, and Nexviazyme, a newer treatment, are dwindling due to what has been described as a bottleneck in the final manufacturing phase, as well as quality control issues at its Waterford plant.” * * *
    • “For now, it is not clear when normal supplies will return because Sanofi has indicated it could take months before production has sufficiently resumed and stabilized. But the shortage will continue to reverberate after that occurs, because it will likely take time for normal inventories to be rebuilt, according to a statement on the IPA website.”

From the judicial front,

  • Beckers Hospital Review reports,
    • “A federal judge has dismissed an antitrust lawsuit brought by compounding pharmacy Strive Specialties against Eli Lilly and Novo Nordisk.
    • “The ruling, filed Aug. 3 in the U.S. District Court for the Western District of Texas, found the company failed to plausibly allege a legally cognizable product market or a cognizable antitrust injury.
    • “Strive filed the lawsuit in January, accusing the drugmakers of using exclusive-dealing agreements with telehealth providers and public statements questioning compounded drugs’ safety to unlawfully restrict competition and limit patient access to compounded GLP-1 medications.
    • “The court found Strive’s compounded products cannot be considered reasonably interchangeable with Lilly and Novo Nordisk’s branded GLP-1 medications, because compounded versions are legally available only when a prescriber determines a branded drug is medically unsuitable for a specific patient. That determination is driven by necessity rather than ordinary consumer preference, the court ruled, undercutting Strive’s proposed cash-pay submarket and its broader GLP-1 market theory alike. Without a viable relevant market, the court found Strive’s Sherman Act and Clayton Act claims, including its challenge to Lilly and Novo Nordisk’s exclusivity arrangements with telehealth platforms, also failed.”
  • Health Exec relates,
    • “A newspaper reporter just got an exclusive peek inside a law-enforcement operation that most Americans—including the well-informed among us—know next to nothing about. He took notes and is sharing what he can. 
    • “The operation is the National Training Operations Center—NTOC, called “Noc” for short—of HHS’s Office of Inspector General (HHS-OIG). It’s largely hidden in plain sight for obvious reasons, but it’s a prime mover in the Trump administration’s ongoing crackdown on healthcare fraud. 
    • “The reporter is Chadwick Moore of the New York Post.” * * *
    • “Here are six telling observations the newshawk offers in his article, posted by the Post on Aug. 6. 
      • “More than a few agents are healthcare professionals who feel passionate about stopping healthcare fraud.” * * *
      • “The stealthy suburban facility features highly realistic mockups of medical offices—physical as well as virtual.” * * *
      • “Often the HHS-OIG anti-fraud team is not catching someone red-handed—they’re proving a negative.” * * *
      •  “A Faraday box is essential equipment for the team.” * * *
      • “HHS-OIG is exempt from HIPAA. * * *
      • “In cities where fraud is rampant, real patients are often part of the problem.” * * * 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “Department of Health and Human Services Secretary Robert F. Kennedy Jr. Aug. 7 declared a public health emergency for Washington state to address the impacts of ongoing wildfires. This follows an emergency declaration approved by President Trump Aug. 4. Because of both a presidential declaration and a PHE, the loosening of certain regulatory requirements for Medicare, Medicaid and the Children’s Health Insurance Program is permitted under the Section 1135 waiver process. 
    • “The Administration for Strategic Preparedness and Response said it has sent regional staff to support Washington state officials and partners with the public health and medical response. The Washington State Hospital Association has also provided a series of resources to assist with response efforts.”
  • The American Medical Association News lets us know “what doctors want patients to know about tickborne illnesses.”
    • “Tickborne illnesses can start with a single bite. Know the signs, prevention steps and when to call a doctor to protect your health.”
  • ALS News Today relates,
    • “Traumatic brain injuries are often linked to a higher short-term mortality risk in patients with ALS [Lou Gehrig’s Disease].”
    • “The connection could suggest reverse causation, where early, undiagnosed ALS leads to falls and resulting head injuries.
    • “Further research is required to evaluate diagnostic timing and clarify the relationship between traumatic brain injury and ALS.”
  • Health Day tells us,
    • “Yoga may help relieve symptoms of irritable bowel syndrome 
    • “People with irritable bowel syndrome who practice yoga experience fewer digestive symptoms, as well as reduced anxiety and depression
    • “Researchers think yoga’s combination of movement, breathing and mindfulness activates the body’s ‘rest and digest’ response.”
  • MedPage Today points out,
    • “In 2024, the national incidence rate of type I diabetes was 24.0 per 100,000 persons under age 20, but state-level rates ranged from 17.0 to 27.8.
    • :The ratio of board-certified pediatric endocrinologists to patients with type 1 diabetes also varied widely.
    • :Three states had fewer than five pediatric endocrinologists per 1,000 patients under age 18; in contrast, Washington, D.C. had 46.4.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Targeted protein degradation is a therapeutic strategy that leverages the ubiquitin–proteasome system to eliminate disease-associated proteins—including those that have traditionally been considered undruggable.
    • “Protein degraders remove unwanted proteins from inside a cell by disposing of them using the cell’s built-in recycling system. Specifically, a molecular glue degrader binds an E3 ligase and redirects it to tag a disease-related protein for disposal.
    • “Now, investigators at Dana-Farber Cancer Institute have developed a platform for systematically discovering molecular glues that could become protein degradation drug candidates. The platform could help drug developers expand the range of disease-related proteins that can be therapeutically targeted for elimination via protein degradation. The platform also enabled their discovery of the first molecular glue degrader that is metabolically activated, suggesting that molecular glues could be more context dependent and potentially tunable than previously thought.
    • “The study was published in Nature in the paper, “DCAF11-dependent molecular glue degrader activated by glutathionylation.”
    • “This novel platform is an exciting scalable approach to the discovery of molecular glues that could help drive the significant expansion of molecular glue applications for the treatment of cancer and other diseases,” says Eric Fischer, PhD, professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School.”
  • STAT News notes,
    • “Tenax Therapeutics on Monday reported negative results from a late-stage clinical trial evaluating an experimental treatment for a type of heart failure associated with high blood pressure in the lungs.” * * *
    • “Despite the failed study, Tenax does not appear ready to give up on oral levosimendan. The company believes the drug may have a benefit for PH-HFpEF patients with more severe disease, based on pre-specified and post-hoc analyses of the LEVEL study. 
    • “Having reviewed the available trial results, I am encouraged we have a clear path forward,” said Tenax Chief Medical Officer Stuart Rich, in a statement.
    • “The company said it will meet with the Food and Drug Administration to discuss the LEVEL study results and potentially make changes to a second Phase 3 study already underway.”
  •  and
    • “Sionna Therapeutics said Monday that its experimental pill for cystic fibrosis did not show any benefit when added onto Vertex Pharmaceuticals’ Trikafta in a Phase 2 trial. 
    • “The company will no longer try to advance the drug, called SION-719, as an add-on therapy for CF patients. And it hinted at potential layoffs, saying it will “take actions to preserve capital while evaluating next steps.”

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

  • Fierce Pharma reports,
    • “Everything is bigger in Texas. And so it is with Bristol Myers Squibb’s $2.3 billion investment in a manufacturing campus in Houston, which comes in at more than twice the price the company estimated in a government application earlier this year.
    • “In May, the New Jersey pharma filed documents with the state of Texas to build a $1 billion, 600,000-square-foot complex, with an option to expand, in the Generation Park Management District in northeast Houston. It was one of several U.S. sites BMS was considering, the company said at the time.
    • “On Monday, BMS made it official in a statement saying it intends to employ nearly 500 at the facility, which will be built to “grow in scale, capability and workforce for decades to come.” It will support drug product and finished manufacturing from late development through launch, the company added, with plans to finish construction in 2030.” 
  • BioPharma Dive adds,
    • “Jazz Pharmaceuticals has agreed to buy a San Diego-based biotechnology company developing treatments for genetic epilepsies, through a deal that could be worth just over $1.3 billion.
    • “Terms hold that privately held Actio Biosciences will receive $820 million up front and be eligible for $500 million in additional payments if its research programs hit certain regulatory and sales milestones. The company’s most advanced drug is being tested against a rare form of epilepsy caused by mutations in a gene known as KCNT1.
    • “The companies expect to close their deal sometime in the final three months of the year. Concurrent with the closing, Actio will spin out a new private entity funded by existing investors and headlined by one of its other programs, an ion channel inhibitor in early-stage testing for a form of “Charcot-Marie-Tooth,” an uncommon neurological disease. Jazz said it will hold a minority stake in the spinout — an investment that, by focusing on rare diseases, “represents a strong strategic fit” for its long-term strategy.”
  • and
    • “The race to build pharma’s most powerful supercomputer gained a new entrant last month, when Bristol Myers Squibb said a newly expanded partnership with Nvidia would give it “the most powerful and energy-efficient single-owned Nvidia infrastructure in life sciences.”
    • “Bristol Myers is the latest large pharmaceutical company to stake an AI-computing superlative claim along those lines. Eli Lilly said in October it would work with Nvidia to build “the most powerful supercomputer owned and operated by a pharmaceutical company.” In March, Roche said an expanded Nvidia collaboration gave it “the pharmaceutical industry’s largest announced hybrid-cloud AI factory,” with more than 3,500 GPUs, or graphics processing units.”
  • Beckers Payer Issues identifies the ten insurers exiting the Affordable Care Act market next year (updated as of today).
  • Beckers Hospital Review points out the 17 health systems with credit rating upgrades and tells us,
    • “A July 21 Center for Healthcare Quality and Payment Reform analysis found 700 rural hospitals are at risk of closing across the U.S. In almost every state, at least some rural hospitals are at risk of closing, with the exception of four. 
    • “The report did not classify a single rural hospital in Delaware, Maryland, New Jersey or Utah as “at risk of closing” or “at immediate risk.”
    • “Becker’s connected with hospital association and state agency leaders in each of those states to discuss what they credit for this stability. Their responses point to geography, a mix of specific state payment policy and long-standing regional partnerships.” 
  • MedTech Dive informs us,
    • “IRhythm said Thursday it has struck a deal to buy VitalConnect for $287.5 million to add mobile cardiac telemetry capabilities. 
    • “VitalConnect sells a wearable device, VitalPatch, that monitors for 21 cardiac arrhythmias and several vital signs. The device lasts seven days, after which users can apply a new patch.
    • “IRhythm sells its own cardiac monitor and is working to secure clearance of a second device, but it has identified VitalPatch as a product that can unlock another part of the market.”  
  • Beckers Clinical Leadership notes,
    • “This year, CMS has implemented eight changes to the HCAHPS survey and scoring.
    • “The changes are part of CMS’ HCAHPS 2.0 launch, which began in 2025. Last year, CMS began allowing patients to fill out the HCAHPS survey online; sunset two survey administration options; added three submeasures for care coordination, restfulness and information about symptoms; extended the data-collection period from 42 to 49 days; ended regulation that prohibits patients’ loved ones from filling out the survey on their behalf; limited the number of supplemental items; and required hospitals to collect information about the language patients speak.
    • “The first results of the HCAHPS 2.0 rollout are due to be published any day, Rick Evans, strategic advisor at New York City-based NewYork-Presbyterian, said in an Aug. 6 column.”
  • Per Fierce Healthcare,
    • “Women’s health companies drew a record $1.55 billion in disclosed equity investment in 2025, up 41% from $1.1 billion in 2024, according to a recent report from W Group.
    • “The report, the organization’s first global women’s health investment report, was built on proprietary tracking of more than 500 funding stories and around 164 equity rounds, and it reveals a sector at its largest-ever scale, with capital reaching more companies, categories and countries than at any point on record, according to W Group, a data-first intelligence platform.
    • “Eighty-five companies raised equity in 2025, the highest single-year count ever recorded, and 10 rounds reached $50 million or more, double the number in 2024.” * * *
    • But the report’s central finding is not the headline number. It is that the money has stopped concentrating at the top. In 2024, the three largest rounds accounted for 41% of all disclosed capital; in 2025 that share fell to 32%, as funding to companies outside the top three grew 56% year over year. 
  • and
    • “Doximity is boosting artificial intelligence spending, viewing it as a significant catalyst for growth, and CEO Jeff Tangney is bullish that hospital adoption of enterprise AI platforms will ramp up.
    • :Doximity is a digital platform for U.S. medical professionals that offers workflow tools such as a telehealth solution, a clinician-to-patient dialer tool and digital faxing capabilities. Its paying customers include pharmaceutical manufacturers, health systems and medical recruiting firms.
    • “The company aims to become a leading AI platform for doctors with plans to scale its clinical AI suite, including its ambient notetaking tool Scribe and clinical AI assistant and medical search engine Ask. A year ago, Doximity acquired clinical AI company Pathway and then integrated Pathway’s datasets and its AI into its free Doximity GPT product to offer DoxGPT (now Ask).
    • “Healthcare AI will increasingly be purchased by hospitals rather than individual physicians, with companies winning on accuracy and trust of the AI, Doximity executives assert.”

Notable Deaths

  • The New York Times reports
    • “Maura Gillison once told an interviewer that she had wanted to be a doctor and a scientist since childhood. She trained in ballet, but as she grew, reaching a height of 6-foot-2, dance became an unlikely career path because she felt that it would draw too much attention to her height.
    • “Instead, she forged a trailblazing career as a medical oncologist and molecular epidemiologist, studying head and neck cancers. In the early 2000s, she was credited as the first researcher to show definitively that the human papillomavirus, or HPV — the most common sexually transmitted infection — caused the so-called oropharyngeal cancers of the throat, tonsils and base of the tongue.
    • “No head and neck medical oncologist has had a bigger impact on patients than Maura Gillison,” Dr. John V. Heymach, the chair of thoracic/head and neck oncology at MD Anderson Cancer Center in Houston, where Dr. Gillison conducted research beginning in 2017, said in an interview.
    • “Dr. Gillison died on June 21 at her childhood family home in Willoughby, Ohio, northeast of Cleveland. She was 61. The cause was a rare cancer of the small intestine, her husband Dr. David E. Symer, an oncologist, said.”
  • Beckers ASC relates,
    • “American College of Cardiology Past President Robert Frye, MD, has died at age 94 after a career spanning more than 70 years in medicine, the ACC announced Aug. 7. 
    • “Dr. Frye served as ACC president from 1991 to 1992 and spent more than 60 years practicing and teaching cardiology at Mayo Clinic in Rochester, Minn.
    • “Dr. Frye earned his medical degree from Vanderbilt University School of Medicine in 1956 and trained in residency at Johns Hopkins Hospital in Baltimore. He went on to become the first physician research fellow and clinical associate at the National Institutes of Health, recruited by Eugene Braunwald, MD, MACC.” * * *
    • Valentin Fuster, MD, PhD, MACC, who worked alongside Dr. Frye as the first Braunwald fellow at the NIH, said Dr. Frye “helped lay the foundation for a generation of clinical discovery that transformed” cardiovascular medicine.
  • RIP. The FEHBlog also encourages his readers to listen to Russ Roberts’ Econtalk discussion with former U.S. Senator Ben Sasse.
    • From the transcript
      • Ben Sasse: “So, to be pushing seven months when you had 90 days to live is pretty great. And, that’s because of the really wonderful experience of being on daraxonrasib, this new miracle drug at UCSF [UCSF] and a few other places, that’s a RAS [renin-angiotensin system] inhibitor. If you’re 80-something, pancreatic cancer might be environmental. If you’re 50 something, like I am, it’s almost always a genetic mutation. 89% of people have a RAS mutation. So, this new drug–there hadn’t been good news in pancreatic cancer in 40 years–this new drug essentially tries to inhibit the RAS mutation’s ability to toggle the on-off switches the wrong way.
      • “The great news is my tumors are down over 80% right now. The bad news is, it’s probably not going to be a cure for me because I presented so far along and so metastasized, but this drug is going to be super-interesting over the next two to ten years.
      • “My two rough byproducts right now of a really aggressive dose of chemo are a real hard time growing skin and hair, so my root follicles on my head are all kind of tingly and falling out and bleeding all the time. So, my scalp is real a bloody mess, but I have an amazing dermatological oncology team at MD Anderson>