Tuesday report

David Ermer

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

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Energy and Commerce Subcommittee on Health held a hearing Sept. 15 to discuss more than a dozen legislative proposals regarding Medicare provider payment and healthcare cybersecurity. The AHA provided comments to the subcommittee on bills designed to improve long-term physician payments, including proposals to increase the budget neutrality threshold in the Medicare physician fee schedule and a bill to replace the Merit-based Incentive Payment System with the Data-driven Performance Payment System. The AHA also commented on bills to provide grants for the adoption of cybersecurity best practices, direct the Department of Health and Human Services to create a strategy for rural hospital cybersecurity staff training, and improve obstetric emergency preparedness in rural healthcare settings.” 
       
  • MedPage Today relates,
    • “Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearing Tuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • “Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearingopens in a new tab or windowTuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • “Committee chairman Sen. Mike Crapo (R-Idaho) took the opposite view. “You have met all of the requirements and standards of this committee in vetting a nominee, and you are completely and well qualified to be deputy secretary at the Department of Health and Human Services,” he told Klomp.” 
  • The Wall Street Journal adds,
    • “Pennsylvania health officials announced Tuesday a fourth measles-associated death, the latest fatality in the commonwealth where recently reported deaths from the vaccine-preventable disease have inflamed politics at the local and national level.
    • “The death follows those of two infants in the state’s Lancaster County in mid-August amid a growing measles outbreak. The state health department’s classification of those deaths spurred a highly politicized debate over vaccinations and sparring between the state’s Democratic governor and the nation’s health secretary.
    • “Over the weekend, a coroner in Pennsylvania’s Jefferson County said a 40-year-old woman there died from complications from measles. The Mifflin County Coroner’s Office on Tuesday said an 18-year-old resident died due to a rare neurological complication from measles. The state health department said it worked with local coroners’ offices to determine both individuals tested positive for measles and the deaths didn’t result from an unrelated cause.
    • “That’s four total measles-associated deaths in our Commonwealth and the first Pennsylvania has seen in 35 years,” Pennsylvania Gov. Josh Shapirosaid in a post on social media Tuesday. “These are tragedies, and four families are grieving.”
  • Per a U.S. Census Bureau news release,
    • “The U.S. Census Bureau today announced that real median household income was $87,460 in 2025, the highest on record dating back to 1967.
    • “The official poverty rate fell 0.5 percentage points to 10.2% in 2025. The following 2025 findings were not statistically different from 2024: the Supplemental Poverty Measure (SPM) rate in 2025 was 13.1% and in 2025, 26.7 million people (7.9%) were uninsured for the entire year, according to the 2026 Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
    • ‘These findings come from three Census Bureau reports, “Income in the United States: 2025,” “Poverty in the United States: 2025” and “Health Insurance Coverage in the United States: 2025.”
  • Beckers Hospital Review tells us,
    • CMS will add four condition tracks to its Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model starting in spring 2027, the agency said in a Sept. 15 news release.  
    • Four things to know: 
      • “The expansion adds heart failure, chronic obstructive pulmonary disease, substance use disorders and tobacco cessation to the model. CMS will also expand support for chronic musculoskeletal pain, extending coverage for certain conditions beyond the model’s initial 12-month care period.
      • “The model already covers hypertension, diabetes, chronic musculoskeletal pain and depression. CMS says 3 out of 4 Medicare beneficiaries qualify for at least one track.
      • “The ACCESS model ties Medicare payments to measurable improvements in patient health rather than paying solely for individual services. Participating organizations can offer virtual care, health coaching, remote monitoring, and connected devices and wearables between regular doctor visits.
      • “There are currently 160 organizations participating in the ACCESS model, and CMS said Medicare will continue to add to the list throughout the model’s 10-year run. The model supports those with traditional Medicare. Medicare Advantage enrollees are not eligible, but CMS said MA plans may offer similar programs.”

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

  • OPM included the following additions in today’s Federal Register.
    • Rules
      • Reduction in Force; Correction
      • Shared Certificates and Pooled Hiring Actions
    • Proposed Rules
      • Promoting Employee Accountability
  • Federal News Network reports,
    • “The fewest number of federal employees submitted their retirement papers in August as compared to the rest of 2026. The Office of Personnel Managements says it received only 7,618 retirement claims last month. This is down from more than 10,000 claims OPM received in July. Additionally, OPM’s backlog of retirement claims is at the lowest of the year at just over 15,400. The average number of days to process a claim for August also dropped considerably: to 70 days for a digital claim, down from 98 days the month before, and to 79 days for all claims, down from 109 days in July. (Federal retirement claims down, as the backlog hit lows for 2026 – OPM)”
  • Kevin Moss, writing in Federal News Network, discusses
    • “Healthcare affordability series part 8: Enrollment flexibility for two-person families can lead to premium savings.”
      • “Most of the time, self-plus-one is cheaper, but there are plans where you’ll save more enrolling as self & family.”
  • Govexec relates,
    • “More ‘Big Balls’-type young feds are what the OPM chief wants 
      • “In an interview on Monday, Scott Kupor also discussed implementing skills-based hiring, which had been a priority of the Biden administration as well.”

From the U.S. Food and Drug Administration front,

  • STAT News relates,
    • “The Food and Drug Administration is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday. 
    • “The pilot was first announced in June as part of Operation TrialBlazer, the Department of Health and Human Services initiative that pledged to shorten the FDA’s drug approval timelines and help the U.S. compete with the rapidly accelerating biotechnology industries in countries like China and Australia.
    • “Too often, the U.S. pathway can be measured in years, while other countries’ pathways are measured in months,” the department wrote in the TrialBlazer roadmap.”
  • and
    • “Vera Therapeutics said Tuesday that its recently approved drug Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in patients with a chronic autoimmune kidney disease, according to final, two-year results from a Phase 3 clinical trial. 
    • “In July, the Food and Drug Administration granted accelerated approval to Trutakna for the treatment of IgA nephropathy, or IgAN, a disease caused by the buildup of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.
    • “With the final data from the study in hand, Vera said it will seek full approval of the drug from the FDA during the fourth quarter.”
  • Cardiovascular Business tells us,
    • “XCath Robotics has received the FDA’s breakthrough device designation for its Iris surgical robotic system that performs remote robotic-assisted mechanical thrombectomy in acute ischemic stroke patients.
    • “This represents a significant step forward for the Houston-based medtech company. The FDA’s breakthrough devices drogram helps support the development of medical devices that have the potential to provide more effective treatment for patients with life-threatening or irreversibly debilitating conditions. This provides XCath Robotics with more opportunities to interact with FDA experts and receive support as the company works toward U.S. regulatory approval for the Iris system.
    • “Back in March, the Iris system was used to complete the world’s first telerobotic stroke thrombectomy. Neurosurgeon Vitor Mendes Pereira, MD, chair of advanced neurovascular interventions at the University of Toronto, used the system to perform the historic procedure in Santiago, Panama, while the patient was 120 miles away in Panama City.”

No Surprises Act News

  • The FEHBlog did receive his CMS invitation to join its Independent Dispute Resolution Gateway this morning, and the FEHBlog promptly took CMS up on its offer. The process went smoothly.
  • The Paragon Institute September 15, 2026, Newletter’s kicks off with an article about “Fixing the No Surprises Act’s Broken Arbitration System.”
    • “Congress already required much of this transparency through the NSA’s Advanced Explanation of Benefits provisions, but those requirements have yet to be fully implemented. The administration should finish that work. Once patients have meaningful advance information about networks and prices, there is no justification for a federal arbitration system setting payments for elective care.
    • “For emergency services, a different approach is needed, and Congress has two reasonable options. It could eliminate federal IDR entirely while maintaining the prohibition on balance billing, leaving insurers and providers to settle payment disputes through private arbitration, litigation, or state law.
    • “Alternatively, Congress could retain IDR solely for emergency services but impose meaningful guardrails. Awards should have a reasonable upper limit so arbitration does not continue producing payments wildly disconnected from market prices. Congress should also reform how arbitrators are paid, and if an upper limit is implemented, insurers should face penalties when they fail to pay awards on time.
    • “The administration can make additional improvements now: require arbitrators to explain their decisions, audit firms with unusually high provider win rates or awards, strengthen eligibility reviews, improve arbitrator training, prohibit conflicts of interest and forum shopping, and restore a meaningful filing fee.
    • “The No Surprises Act solved a real problem by protecting patients from bills they could neither anticipate nor avoid. Those protections should remain. But protecting patients from surprise bills does not require a federal arbitration system that rewards providers for staying out of network and raises health care costs for everyone.”

From the fraud, waste, and abuse front,

  • Healthcare Dive reports,
    • “The federal government is once again targeting fraud in durable medical equipment suppliers, publishing a report Monday through the HHS’ Office of the Inspector General that urges regulators to crack down on suspect billing in Medicare Advantage.
    • “The OIG found that, in addition to other issues, MA organizations don’t screen for fraudulent medical equipment suppliers as often when they’re out of network, compared to in-network suppliers.
    • “MA organizations should tighten the screening process for suppliers and the CMS should use its fraud prevention tool more regularly, the OIG said.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “In recognition of Suicide Prevention Month, Susan Szulewski, M.D., president and chief operating officer, McLean Hospital and vice president, Mass General Brigham Behavioral and Mental Health, wrote on the importance of healthcare organizations working to reduce the stigma surrounding suicide and create a supportive environment with timely access to care and a clear path forward. READ MORE“
  • Per a CDC news release,
    • “Today, the Centers for Disease Control and Prevention and the Ad Council are launching a new round of public service announcements (PSAs) encouraging people to understand their risk of prediabetes and take action to prevent or delay type 2 diabetes.
    • “Now in its 10th year, the national “Do I Have Prediabetes?” campaign encourages viewers to take a 1-minute prediabetes risk test on DoIHavePrediabetes.org. This year’s “Undo It” PSAs spotlight that while there are many scenarios in life we can’t undo, prediabetes is something that can be reversed. 
    • “Prediabetes is a serious health condition that increases the risk of type 2 diabetes, heart attack and stroke. Because prediabetes often has no symptoms, many people do not know they have it. Research shows that early diagnosis can inspire individuals to adopt healthier habits, including eating better, being active and managing weight, that can reverse prediabetes and delay or prevent type 2 diabetes.
    • ‘If someone receives a high score on the risk test, that person is encouraged to speak to a doctor to confirm a diagnosis of prediabetes with a blood test, then enroll in the National Diabetes Prevention Program.” 
  • Healio tells us,
    • “Development of alcohol use disorder, depression or stress after a traumatic event was a strong predictor of major adverse cardiac and cerebrovascular events for both men and women, researchers reported.
    • “Evaluation of psychiatric predictors of major adverse events may be an important step in the prediction of CV risk after a traumatic event, according to data published in the Journal of the American Heart Association.
    • “Experiencing traumatic events can have long-lasting consequences for mental health that can take many forms, but research to date had yet to comprehensively consider these. Indeed, nearly all work on trauma and CVD had focused on PTSD and other stress-related disorders — the quintessential trauma-related mental health disorders — but depression, anxiety and substance use disorders are also common following trauma and are relevant to cardiovascular disease risk,” Jennifer A. Sumner, PhD, associate professor of psychology at the University of California, Los Angeles, told Healio. “We wanted to comprehensively investigate different posttraumatic mental health conditions as possible predictors of CVD onset. Also, given sex differences in both posttraumatic psychopathology and CVD, we examined whether links between various psychiatric disorders following trauma and CVD might differ for men vs. women.”
  • Health Day informs us
    • “New research suggests that the blood pressure and heart rate guidelines doctors use to guide emergency treatment in children are misleading in cases of traumatic injury. 
    • “These thresholds for “hemodynamic instability” — the inability of the circulatory system to get blood to organs — may be different for children with traumatic injuries versus healthy children, researchers wrote Sept. 9 in the Journal of the American College of Surgeons.
    • “Recognizing hemodynamic instability is fundamental in trauma care because these vital signs tell us when a child may be at increased risk of death or complications and when we may need to intervene,” explained study senior author Dr. Zain Hashmi. He’s an assistant professor of trauma and acute care surgery at the University of Alabama at Birmingham.
    • “Blood pressure and heart rate guidelines are often used by doctors to decide when to start resuscitation treatments, including blood transfusions, Hashmi said in a news release. However, the values used in children were not developed specifically for trauma patients and may not accurately reflect when the risk of death begins to rise in injured children, he added.” 
  • Medscape points out,
    • “A new international consensus statement providing evidence-based guidance on smoking cessation for people with type 2 diabetes (T2D) has been issued by a multidisciplinary international panel called the DiaSmokeFree Working Group. 
    • “The central message “is that smoking cessation needs to be treated as an integral part of diabetes management rather than as generic lifestyle advice,” statement co-author Riccardo Polosa, MD, PhD, professor of internal medicine at the University of Catania in Catania, Italy, told Medscape Medical News.
    • “There is evidence that this is under-prioritized in diabetes care,” he added. “Clinicians understandably focus on glucose, blood pressure, lipids, and medications, while smoking may receive only brief and mostly ineffective advice.”
  • Today’s issue of NIH’s Research Matters covers the following topics:
    • “Depression may stall development of new neurons 
      • “Researchers found that a part of the brain important for memory struggles to make new neurons in people with depression.
      • “The study sheds light on how the brain is altered in depression and suggests new treatment targets.”
    • GLP-1 drug slows aging in mice 
      • A GLP-1 drug extended lifespan and prevented age-related decline in older female mice.
      • Understanding how calorie restriction and GLP-1 drugs slow aging could lead to new ways to treat age-related diseases.
    • Antibodies may prevent tick-related syndrome 
      • “Researchers identified rare antibodies that may help combat alpha-gal syndrome, a condition that causes allergic reactions to red meat and dairy products.
      • “With further development, the finding could lead to treatments for this tick-related allergic condition.”

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

  • Beckers Payer Issues reports,
    • “Aetna’s two-year financial turnaround has taken hold following a leadership overhaul, thousands of ongoing cost management initiatives and a margin recovery plan expected to complete by 2027.
    • “Once you get the fundamentals in place, you start getting credibility, not only with investors, but internally with our employees, and then, in particular, with our members,” Aetna President Steve Nelson said Sept. 9 at the Wells Fargo Healthcare Conference. “We can be a little more disruptive and innovative. Aetna has a legacy of being innovative in terms of product and clinical programs, and we are getting back to that.”
    • “The insurer has spent the past two years in recovery mode after a period of financial turmoil driven by Medicare Advantage cost pressures, previously unfavorable star ratings and major losses in the ACA business, which it exited for 2026. Mr. Nelson, who also serves as executive vice president at CVS Health, was tapped to lead the insurer in late 2024.”
  • and 
    • “Health Care Service Corp. has completed the rebranding of its Medicare supplement and supplemental health and life products under the HealthSpring name.
    • “The move finishes a transition that began last year, when HCSC shifted the Medicare Advantage and Part D business it acquired from Cigna for $3.3 billion to the HealthSpring brand. 
    • “HealthSpring has more than 3 million members. HCSC said it is the second-largest Medicare supplement carrier by policyholders, with plans available in 48 states and Washington, D.C. Its supplemental health and life products, which include hospital indemnity and dental, vision and hearing benefits, are offered in 49 markets and D.C.”
  • and
    • “The Blue Cross Blue Shield Association has tapped Daniel Serrano to serve as CFO.
    • “The president and CEO of the BCBS Association, Kim Keck, announced the update Sept. 14 on LinkedIn. 
    • “With critical capabilities for this moment, including a practitioner’s orientation to data-driven financial management and a strong track record of aligning financial performance with operational outcomes, Dan is a great fit for our organization,” she said.”
  • Fierce Healthcare adds,
    • “Member trust in insurers is on the decline among Gen Z and Millennials, down 10.5% between 2023 and 2026, new research from Accenture found.
    • “This trust gap, according to analysts, could cost $3 billion in future member lifetime value for the largest commercial payers over the next decade. 
    • “When members don’t trust their health plan, they don’t just disengage; they route around it,” said Bracken Flynn, Accenture’s Health industry principal director, in a statement. “Our data shows that younger consumers aren’t asking for less from their insurer. They want more. They’re looking for a partner that helps them navigate care, understand costs, and make confident decisions. The insurers that earn that trust now will define what health coverage means for the next generation.”
    • “During a Sept. 14 AHIP webinar, Flynn said the report—which polled 1,200 consumers—found members trust insurers when they believe the health plan will help them make good healthcare decisions and navigate them to the best care.
    • “That’s across clinical and administrative touchpoints,” Flynn said. “And so it’s a partnership. In practice, it’s a partnership.”
    • “The lack of trust in insurers is causing younger members to turn to artificial intelligence tools, with 62% of respondents saying they have used AI to help choose a health plan.”
  • The American Hospital Association News relates,
    • “A new report from Kaufman Hall prepared for the AHA highlights new insights and data on hospital mergers and acquisitions. An AHA blog accompanying the report is also available.
    • “The report discusses how hospital merger reviews should look beyond the potential impact on commercial insurance prices and consider what proposed transactions mean for all patients, particularly the nearly 60% of hospital patient days attributable to Medicare, Medicaid and Medicare Advantage beneficiaries whose payment rates are largely set by government programs. Drawing on analyses of challenged and canceled transactions, the report also finds that hospitals seeking partners often serve more vulnerable communities and face greater financial pressures, and that when proposed deals do not move forward, struggling hospitals can experience significant financial deterioration that threatens services, workforce stability and access to care.
    • “These findings suggest that a more comprehensive analysis of hospital M&A transactions, one that considers impacts on all patients served, broadens the focus to impacts beyond pricing, and considers the consequences if an M&A transaction is not permitted to proceed, would ensure not only competitive but also healthy hospital markets that can continue to provide the fullest possible range of services,” the report says.”
  • AHIP relates,
    • “New data highlighted by Washington Post Intelligence show hospital system consolidation continues to accelerate, with 40 new mergers and acquisitions announced already in the first half of 2026 — nearly as many as throughout all of 2025. 
    • “Clear evidence demonstrates that anticompetitive hospital consolidation leads to higher healthcare costs for patients, families and employers. Hospital spending already makes up the largest share (40%) of insurance premiums, accounting for over $1.6 trillion in spending nationwide.”
  • Beckers Hospital Review adds,
    • “Salt Lake City-based Intermountain Health has acquired the nine-story, 235,000 square-foot Fairbourne Building in West Valley City, Utah, and plans to convert it into a medical campus.”
  • and
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said.”
  • Cardiovascular Business points out,
    • “U.S. News & Report has published its annual ranking of the top children’s hospitals in the United States, once again producing a separate list for the best hospitals for cardiology and heart surgery. This represents the 20th year that U.S. News.& World Report has compiled these rankings.
    • “For two decades, U.S. News has helped guide families to top-tier pediatric care,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement. “Finding the right medical team for a rare diagnosis or complex surgery can be overwhelming, and U.S. News’ annual evaluation of the Best Children’s Hospitals provides a clear starting point for parents and referring pediatricians alike.”
    • “Nearly 200 U.S. facilities were eligible for these rankings. Each one is either a freestanding children’s hospital or a large multidisciplinary pediatric department working within a major medical center.
    • “This latest ranking of the Best Children’s Hospitals for Cardiology and Heart Surgery includes some familiar names at the top. For instance, Texas Children’s Hospital in Houston is No. 1, just like it was in 2019, 2020, 2021, 2022, 2023, 2024 and 2025. 
    • “Meanwhile, Children’s Hospital Colorado and Duke Children’s Hospital and Health Center are No. 2 and No. 3, respectively. That is where each one landed in the previous year’s ranking as well. 
    • “Going a bit deeper, Children’s Hospital of Philadelphia came in at No. 4, and Children’s Health Dallas came in at No. 5.” 
  • MedCity News lets us know,
    • “Virtual solutions for chronic kidney disease (CKD) management don’t slow disease progression, nor do they reduce total healthcare spending, according to a new analysis by the Peterson Health Technology Institute (PHTI).
    • “PHTI is an independent evaluator of digital health solutions. For the analysis, PHTI reviewed more than 5,400 articles and other evidence. The solutions evaluated in the report include DaVita IKC, Evergreen Nephrology, Healthmap Solutions, Interwell Health, Kidneylink, Monogram Health, Somatus and Strive Health. These companies take on financial responsibility for the total cost of care for patients with stage 3–5 CKD, and typically work with Medicare Advantage plans and Medicare’s Kidney Care Choices model.
    • “The assessment focuses on managing chronic kidney disease before patients progress to end-stage kidney disease, including the need for dialysis or a kidney transplant.”
  • Managed Healthcare Executive tells us,
    • “GLP-1s now dominate market momentum, with obesity products surging from near-zero in 2022 to $55B annually and diabetes GLP-1s sustaining double-digit year-over-year growth. 
    • “Independent pharmacies are reassessing dispensing economics, with refusal rates declining to 35% for weight-loss GLP-1s and 8% for diabetes GLP-1s. 
    • “Distribution remains retail-heavy (~80%), but mail fulfillment is increasing, reaching 12.9% of GLP-1 prescriptions as direct-to-consumer channels expand. 
    • “Diabetes category mix is shifting away from insulin, whose sales share has dropped to 9.8% and prescription share to 16%, reflecting GLP-1 substitution dynamics. 
    • “Medicare Part D Bridge uptake appears immediate, with 9,000 paid claims in three days, alongside a large pipeline exploring neuropsychiatric, SUD, cancer-risk, women’s health, and systemic inflammation indications.”
  • The Wall Street Journal informs us,
    • “Legend Names Novartis Executive as CEO
      • “Ingrid Zhang takes the helm of the cancer therapy company, filling a post vacant since its previous CEO abruptly resigned in July.”
  • Per Beckers Health IT,
    • “Oracle has expanded its fiscal 2026 restructuring plan by approximately $700 million, bringing expected costs to roughly $2.8 billion as the company pursues strategic initiatives and operational efficiencies that include adopting and integrating AI across certain functions.
    • “The Sept. 11 Securities and Exchange Commission filing does not specify what actions the additional $700 million will cover or how many employees could be affected. Oracle said restructuring expenses under the broader plan include employee severance, contract termination and other exit costs.
    • “As of Aug. 31, prior to the additional $700 million, Oracle estimated total restructuring costs of up to $2.1 billion.
    • ‘The disclosure comes as Oracle employees across social media reported a recent round of layoffs, including at Oracle Health. Business Insider first reported the layoffs Sept. 14, citing three people affected and an email notification.”
  • and
    • “Mayo Clinic and Thermo Fisher Scientific have launched Precure, a joint venture designed to detect biological signs of disease before patients develop symptoms, according to a news release shared with Becker’s.
    • “Rochester, Minn.-based Mayo Clinic, will serve as majority owner of the entity and Thermo Fisher joins as a minority partner. Precure will build one of the world’s largest human multi-omics datasets — integrating proteomic and genomic data with longitudinal clinical information drawn from 1 million biospecimens collected over several years, according to the release.
    • “At Mayo Clinic, we are committed to transforming patient care through innovation,” said Gianrico Farrugia, MD, president and CEO of Mayo Clinic. “By harnessing the full potential of multi-omics data, Precure, LLC aims to help us better understand disease before symptoms appear.”
    • “Thermo Fisher will contribute its Olink Explore HT proteomics platform and Orbitrap mass spectrometry technology to the effort. Marc Casper, Thermo Fisher Scientific’s chairman and CEO, said the venture has “the potential to create a step change in how we generate and apply multi-omics data to improve human health.”
    • “Target disease areas include cancer, cardiometabolic conditions, neurological disorders and immune-mediated disease — conditions where biological changes often precede clinical diagnosis by years. Advanced AI and large-scale data analytics will be used to identify patterns across the datasets and translate them into actionable insights.”
  • Per Beckers Clinical Leadership,
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said. 
    • “These efforts aim to create a public, multimodal dataset to “help reach a future where cancer patients can get rapid personalized cancer vaccines when they are diagnosed,” the OpenAI Foundation said in a Sept. 15 news release. 
    • “UNC Lineberger’s $40 million grant is part of a $125 million funding program, called Public Data for Health, established by the foundation.”
  • and
    • “Ambient artificial intelligence handed many physicians their evenings back. For nurses, the same promise is proving harder to keep, and the reason is buried in the flow sheet.
    • “Physician ambient scribes listen to a visit and draft a narrative note when it ends. Nursing documentation does not work like that. It lives in structured flow sheets, entered field by field across a shift, every time a nurse assesses, medicates or turns a patient.
    • “Nursing documentation occurs throughout the entire shift. It’s every time we interact with a patient,” said Stephanie Clements, BSN, RN, senior vice president and chief nurse executive at Chesterfield, Mo.-based Mercy. “It’s very different than summarizing care at the end of a period.” 
    • “That difference is why early attempts to copy the physician model — record the encounter, generate the note — have not mapped cleanly onto the bedside, and why some nurses have found the tools slower, not faster, at first.
    • “Yet the systems furthest along say the payoff is real when the technology is built for nurses from the get-go.” 

Notable Deaths

  • The New York Times reports
    • “Harold P. Freeman, an influential oncology surgeon whose knowledge of the devastating effects of breast cancer on poor Black women inspired him to create a landmark program at Harlem Hospital Center, helping patients navigate the health care bureaucracy, died on Aug. 11 in Atlanta. He was 93.
    • “His death, at a hospital, was confirmed by his son Neale.
    • “Dr. Freeman’s patient navigation program became a model for hospitals around the world, helping to eliminate barriers to early cancer detection. The program’s success influenced the passage of the federal Patient Navigator Outreach and Chronic Disease Prevention Act of 2005, which provided $25 million for similar programs across the United States. In 2024, Medicare began providing providers with reimbursement for some navigation services for cancer, heart failure, H.I.V./AIDS and other high-risk conditions.
    • “There are no navigation events or meetings that don’t acknowledge Dr. Freeman’s role in patient navigation,” Dr. Shanthi Sivendran, the interim chief patient officer of the American Cancer Society, said in an interview. “There wasn’t a patient navigation concept before him.”
  • and
    • “The milk truck would pull up to the house, and out would come the groceries — not just milk, but also eggs, cheese, juice, cereal and baby formula. It might have stopped at a rich family’s house, or a poor one. No one could tell the difference, which was precisely the point.
    • “Vermont’s supplemental food program for low-income women, infants and children, the first in the nation to be implemented statewide, began in 1974. It was the brainchild in part of Dr. Anthony Robbins, then one of the country’s youngest state health commissioners, at 33; he had secured a federal grant to made the program possible.
    • “Not only did the program provide much-needed supplies, but it also shielded families from the stigma of receiving public assistance.
    • “The milk truck was stopping at practically every house — high income, low income, whatever,” Donna Bister, a former director of the program, known widely as WIC, said in an interview. The program is now available in all 50 states.” * * *
    • “Dr. Robbins died on July 5 at his home in Rockport, Mass. He was 85. His death, which was not widely reported at the time, was caused by complications of long Covid, heart disease and Parkinson’s disease, his wife, Phyllis Freeman, said.
    • “He was considered to be on the cutting edge of health care,” Madeleine Kunin, a former governor of Vermont, said in an interview. “He was a bright light.”
  • RIP Doctors.

Monday report

David Ermer–Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Beckers Payer Issues reports,
    • “Pharmacies have been seeing compelling interest in Medicare’s GLP-1 Bridge program since its July launch, NPR first reported.
    • “The demonstration, designed to give eligible Medicare Part D beneficiaries access to certain GLP-1s at a fixed monthly cost, will run through 2027. Manufacturers are supplying GLP-1s at a monthly net price of $245, and beneficiaries cover $50. Unlike the proposed voluntary “Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth” — or BALANCE — model pilot, Bridge bypasses Part D sponsors.” * * *
    • “Becker’s connected with Walgreens and CVS Health to unpack how Bridge has been progressing so far. To date, each company has filled more than 100,000 GLP-1 prescriptions through the program.
    • “We have seen actually uptake be pretty strong in the first part of the program,” Rick Gates, chief pharmacy officer for Walgreens, told Becker’s. “… I would say it is far exceeding from a volume perspective what we expected at this point.”
    • “Mr. Gates said Bridge is continuing to grow. When asked about expectations for 2027, he said the program could still hit a ceiling with participation, though.”
  • Beckers Hospital Review relates
    • “Federal health officials are exploring how Medicare could pay for artificial intelligence tools that provide medical care or diagnoses as the Trump administration pushes to expand the technology’s role in patient care, The New York Times reported Sept. 14.
    • “Officials are working to develop a new Medicare payment category that could reimburse companies for AI software supporting medical care or diagnosis, according to the Times. Medicare officials have also encouraged private insurers to reimburse for certain forms of technology-supported care if they improve care and lower costs.
    • “The efforts come as federal officials move forward with several initiatives involving AI in patient care, including technologies capable of performing tasks traditionally handled by physicians.
    • “Within the administration, officials have discussed whether AI doctors operated by technology companies and startups should be paid as much as 60% to 80% of what human physicians earn for the same service, according to a person involved in the discussions cited by the Times.
    • “The payment discussions are unfolding as regulators determine how to oversee increasingly autonomous AI tools. The FDA has approved more than 1,500 medical devices that include AI and perform discrete tasks, such as identifying tumors or blood clots. But the agency does not have rules designed to address newer models, including chatbots and agentic AI systems capable of performing tasks such as prescribing medications.”
  • Fierce Healthcare tells us,
    • “The country’s largest hospital lobby is urging antitrust regulators to look beyond commercial insurance prices and market-wide concentration when weighing the impact of a proposed hospital merger.
    • “The American Hospital Association (AHA), armed with a new analysis report commissioned from healthcare advisory firm Kaufman Hall, called on Monday for a “more comprehensive analysis” of deals under increasing scrutiny because research ties consolidation to higher healthcare prices. 
    • “Regulators, the association and the report said, should place more weight on the types of patients merging hospitals serve, what could happen to care delivery if a deal falls through, and how hospitals within a shared market compete at the service-line level.
    • “Hospital mergers receive careful antitrust review. But careful review is not the same thing as a narrow review,” AHA General Counsel and Secretary Chad Golder wrote in a blog post highlighting the new report. “The relevant question is not just whether a transaction might affect the prices commercial insurers negotiate. It is what the transaction—or its failure—is likely to mean for patients: whether healthcare services remain available, whether hospitals can invest in their workforce and facilities, and whether local communities retain access to care.”
  • Healthsystem CIO informs us
    • “Almost 90 percent of the information blocking complaints filed with the federal government target healthcare providers, according to ASTP. The portal collecting them had logged 2,450 claims through July 31, up from roughly 1,600 in February. The conduct those claims describe is records release, patient registration and app access. That puts a health system’s exposure inside workflows the technology executive rarely supervises.”

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

  • OPM released the following request for public input today in the Federal Register,
    • This request for information (RFI) seeks public input on how to optimize health benefits plan options offered in the Federal Employees Health Benefits (FEHB) Program, which includes the Postal Service Health Benefits (PSHB) Program, to give enrollees high value choices at competitive costs while ensuring the appropriate number and distribution of options are available to enrollees. Currently, health benefits plans in the FEHB Program are limited to offering three options or two options and a high-deductible health plan (HDHP) pursuant to 5 CFR 890.201(b)(3)(i). The information gathered through this RFI will inform the Office ofPersonnel Management (OPM) as to whether modifications to the current FEHB regulations are needed through future notice and comment rulemaking as OPM explores ways to optimize the FEHB and PSHB portfolio and provide enrollees with high value choices at competitive costs.
    • The public comment deadline is November 16, 2026.
  • FEHBlog observation — In order for such a proposal to be successful, OPM should allow plans to combine plan reserves and use a combined medical loss ratio so that the new options can grow.

From the Food and Drug Administration front,

  • Reuters reports,
    • “Doctors, veterans, pharmacists and therapists on Monday urged the U.S. Food and Drug Administration to establish clear safety ‌and access standards for psychedelic therapies during a four-hour public meeting convened by the agency amid efforts to speed up their development.
    • “The hearing is the latest in a months-long push launched by U.S. President Donald Trump’s administration in April to bring qualified psychedelic drug programs to market.
    • “Discussions at the ​meeting focused on practical issues that could shape how psychedelic therapies are tested and delivered, including provider training ​and credentials, patient screening and monitoring, access and reimbursement, clinic capacity and the collection of long-term ⁠safety data.
    • “Experts said any approved psychedelic treatment must include trained staff in the room during sessions — which could last six ​to 12 hours — alongside proper screening, follow-up care and community support.”
  • STAT News adds,
    • “Definium Therapeutics said Monday that its LSD therapy helped patients with anxiety in a second late-stage trial, setting up the company to seek the first approval of a psychedelic drug for anxiety.
    • “In the 12-week trial, patients taking a 100-microgram dose of the drug, called DT120, experienced a 9.8-point drop on a test called the Hamilton Anxiety Rating Scale, while those on placebo experienced a 4.7-point drop. The difference of 5.1 points is similar to what was seen in Definium’s first late-stage anxiety study and larger than what’s been observed with many other anxiety therapies, though it’s difficult to compare results across studies.
    • “Definium is among the first wave of biotechs nearing regulatory approval for psychedelic therapies, a class of treatments that may be especially attractive to patients since they appear to exert rapid benefits. (In the latest trial, Definium said patients experienced changes as early as the second day after dosing.) In contrast, the effects of traditional options like antidepressants take weeks to kick in.
    • “However, commercializing the drug could be challenging. Patients will have to commit a large amount of time traveling to a clinic and taking the treatment under monitoring by a clinician, potentially for up to eight hours. 
    • “Still, Definium’s development approach may give it an advantage. Many other biotechs are studying psychedelics specifically in depression, including Compass Pathways, which is furthest ahead with its psilocybin candidate. Definium is testing its therapy in both anxiety and depression, and because there are so many people with both conditions, doctors may be inclined to prescribe Definium’s product to such patients.”
  • The Wall Street Journal notes
    • Regulators are trying to curb the supply of illicit, unapproved versions of Eli Lilly’s experimental weight-loss drug retatrutide.
    • The black-market compound enters the U.S. from overseas suppliers, often based in China or India, and is sold by clinics and online sellers.
    • The Ohio State Board of Pharmacy conducted 1,102 proactive inspections of wellness clinics and medical spas between March 2025 and August 2026.
  • BioPharma Dive relates,
    • “The Food and Drug Administration has approved a new kind of medication for the rare genetic disease spinal muscular atrophy. 
    • “Called apitegromab and to be sold as Isembyld, the treatment on Friday was cleared for use alongside existing targeted therapies in adults with SMA as well as children at least 2 years of age. For a typical SMA patient, the drug will have an annual list price of about $310,000 per year, executives revealed on a Monday conference call. Costs will vary person-to-person based on a patient’s weight and insurance coverage.
    • “Isembyld’s clearance will once again change the treatment landscape for a potentially lethal disease that had no approved medicines as recently as a decade ago.” 
  • MedTech Dive tells us,
    • “Beta Bionics received Food and Drug Administration clearance on Friday for the company’s first insulin patch pump.
    • “The device, called Mint, has a three day wear time and a 200-unit insulin reservoir. It is designed with a mixture of disposable and reusable components. 
    • “Leerink Partners analyst Mike Kratky wrote in a research note Monday that the FDA authorization should help level the playing field with competitor Insulet, which has dominated new device starts with its patch pump.”
  • Radiology Business adds,
    • “The U.S. Food and Drug Administration has approved a new brain cancer imaging agent from Telix, the Australia-based pharma firm announced Monday. 
    • “Pixclara is a radioactive diagnostic drug paired with positron emission tomography imaging. It’s used to help doctors distinguish between returning brain cancer or harmless changes caused by previous treatments.
    • “The agency’s approval of Telix’s New Drug Application comes after the company previously received a rejection from the agency last year. 
    • “As the first FDA-approved PET imaging drug for glioma [a type of brain cancer], Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients,” Kevin Richardson, CEO of Telix Precision Medicine, said in a statement Sept. 14.” 

From the judicial front,

  • Beckers Hospital Review reports,
    • “Brentwood, Tenn.-based optometric physician Helen Boerman has been sentenced to 42 months in federal prison for defrauding Medicare and other government health care programs out of nearly $7 million, according to a Sept. 14 news release from the U.S. Attorney’s Office for the Middle District of Tennessee.
    • “Ms. Boerman, 48, used her practice, Brentwood Eye Care, to submit false Medicare claims over about three and a half years, billing for services patients did not receive and for wound care products she split for single use rather than purchasing separately, according to court documents. She also submitted false claims to TennCare and the Federal Employees Health Benefits Program between March 2020 and October 2024. As part of her guilty plea, she admitted to submitting roughly $11 million in false claims and receiving about $6.9 million.
    • “Chief U.S. District Judge William Campbell Jr. imposed the sentence Sept. 10, along with one year of supervised release, $6.9 million in restitution and a $100 special assessment.”
  • The Wall Street Journal reports,
    • “Abbott Laboratories has agreed to pay $385 million to settle allegations related to its management of a baby formula facility where deadly bacteria was suspected of causing infant deaths, the Justice Department said Monday.
    • “The settlement is a more lenient outcome than some prosecutors had advocated for, believing they had evidence to criminally charge Abbott under a law that has been used to pursue other businesses for selling contaminated foods, the Journal previously reported. But senior Justice Department officials believed criminal charges would have been heavy handed and closed the probe. 
    • “They opted instead for the civil settlement, which claws back money the company earned from selling formula through federally funded nutrition programs.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “In 2024, 71.5% of adults reported experiencing fatigue at least some days in the past three months, a Sept. 3 CDC report found. 
    • “The CDC used 2024 National Health Interview Survey data to estimate fatigue symptoms among about 27,000 adults 18 and older. Fatigue statistics are based on the reported frequency of fatigue in the past three months. Fatigue is defined as physical or mental tiredness or exhaustion that does not improve with additional sleep or rest. 
    • “Fatigue is “one of the most frequently reported health concerns in primary care visits in the U.S.,” sociologist Natalie Young, PhD, lead author of the report, said.”  
    • “Among adults who reported fatigue in the past three months, 54.9% of adults reported it on some days, 10.7% most days, and 5.9% every day.
    • “Frequent fatigue was most common among women at 20% — compared to 13% of men — and younger adults.”
  • Wallet Hub offers a chart showing the U.S. States that vaccinate the most.
    • “In order to see where people are most responsible about getting vaccines, WalletHub examined the 50 states and the District of Columbia across 16 key metrics. Our data set ranges from the rates of children, teens and adults vaccinated against various diseases to the share of people without health insurance.”
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) is awarding $21 million to launch a research program aimed at spurring the development of computer-based methods that model and simulate the self-regulating processes of human hormones, known as hormone homeostasis. Hormone activity varies widely, resulting in differences in how men and women react to drug therapy, including varying outcomes to dosing, treatment response, and drug toxicity. The program, known as the Computational Modeling of Hormone Homeostasis Initiative, will advance novel human-based, data-driven models tailored to a man or a woman’s complex physiology through advanced computational techniques.
    • “Current mathematical and animal models do not sufficiently capture variations between men and women. Addressing this gap is critical to the understanding of sex-specific biology and the development of more individualized approaches to therapeutics,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives. “By leveraging advanced computer-based models that use human biological data to simulate hormone activity across the lifespan, we can help researchers improve the evaluation of new treatments and support more informed clinical decisions.”
  • and
    • “A National Institutes of Health (NIH)-funded scientific team has shown that a new brain-computer interface (BCI) can allow people with vocal tract and bodily paralysis to convey both speech and upper-body gestures simultaneously. While BCIs have facilitated one or the other in the past, this new system is the first to enable both modes of communication at once, more closely replicating natural expression.
    • “Scientists at the University of California, San Francisco, used machine learning to decipher the unique brain activity that underpins concurrent speech and physical gesture in three patients. Their BCI successfully translated the thoughts of two participants into commands that dictated the expressions of a full-body virtual avatar.
    • “Conversation is about much more than the words being spoken. It’s a multilayered, dynamic process involving the whole motor cortex,” said corresponding author Edward Chang, M.D., a professor of neurological surgery at UCSF. “This proof-of-concept shows us it’s possible for a BCI to restore some of this freedom and flexibility.”
  • and
    • “Advancing Childhood Cancer Research: A Conversation with Dr. Brigitte Widemann.”
      • “September is Childhood Cancer Awareness Month, a time to recognize children and adolescents with cancer, their families, and those working to improve their lives. Brigitte C. Widemann, M.D., is chief of the Pediatric Oncology Branch in NCI’s Center for Cancer Research and special advisor to the NCI director for childhood cancer. A pediatric oncologist and physician-scientist who cares for patients at the NIH Clinical Center, she has devoted her career to developing better treatments, particularly for young people with rare tumors and genetic cancer predisposition syndromes. In this Q&A, Dr. Widemann discusses recent advances, the importance of sustained federal investment, and the promise of shared data and artificial intelligence.”
  • Health Day relates,
    • “Patients with a cancer diagnosis have an increased risk for ischemic stroke (IS), with risk peaking during the first three months, according to a study published online Sept. 8 in Cancer.
    • “Carmit Libruder, from the University of Haifa in Israel, and colleagues conducted a retrospective cohort study linking the Israel National Cancer and Stroke Registries to examine the risk for IS after cancer diagnosis. Residents aged 40 years and older diagnosed with a first invasive cancer during 2014 to 2021 were followed for first-ever IS within one year.”
  • and
    • “A spinal implant can significantly reduce pain suffered by people with diabetes-related nerve damage, a new study says.
    • “Spinal cord stimulation blunted pain and improved sensation in patients suffering from diabetic neuropathy, researchers reported Sept. 9  in the journal Diabetes Care.” 
  • Beckers Behavioral Health informs us,
    • “Frequent smartphone check-ins predicted 75% of suicide attempts and 87% of suicide-related events like hospitalization in the week before they occurred, according to a Sept. 11 Boston Globe report. 
    • “Researchers from Cambridge, Mass.-based Harvard followed 619 adults and adolescents who had sought care for suicidal thoughts or behavior at two Boston-area hospitals. On a sliding scale from 1 to 10, participants were asked how hopeless and agitated they felt, how strong their urge to kill themselves was and how capable they felt of resisting that urge. For three months, participants received 20-question surveys on their smartphones six times a day. Researchers used the responses and information about survey completion in machine-learning models to predict suicide attempts or other suicide-related crises in the following seven days. 
  • MedPage Today points out,
    • “Menopause hormone therapy is FDA approved for other common menopause symptoms but not for mood disturbances.
    • “In an observational study, women using menopause hormone therapy had significantly improved scores for psychological symptoms, including depressive mood, irritability, anxiety, and mental exhaustion.
    • “The proportion of patients with severe mood symptoms decreased from 62.3% at baseline to 24.6% at follow-up.”
  • and discusses
    • “Preserving Muscle During GLP-1 Weight Loss
      • — Experts advise tracking body composition, boosting protein, and resistance training.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of a study by scientists at Wellcome Sanger Institute, University of Cambridge, University College London, and collaborators indicate that cancer treatments, including chemotherapy and radiotherapy, give a growth advantage to cells with particular genetic changes in healthy tissue. The team used DNA sequencing to map mutations in normal esophagus tissue from esophageal cancer patients who had received either chemotherapy, chemotherapy and radiotherapy, or no treatment before surgery.
    • “The results showed that different cancer treatments changed the landscape of mutations in normal tissue. In particular, combined treatment using chemotherapy and radiotherapy led to significantly more normal cells with cancer-related mutations in these patients. The team suggests that sequencing normal tissue from cancer patients receiving treatment could show how our genes regulate our tissue’s response to drugs, including side effects.”
  • Per BioPharma Dive,
    • “Akeso and Summit Therapeutics’ experimental dual-acting cancer drug helped people with lung cancer live about eight months longer than those who got Merck & Co.’s Keytruda in a Phase 3 clinical trial and showed an even stronger benefit in people whose tumors express high levels of a protein that both medicines target.
    • “The findings could help Akeso and Summit shed doubts about the promise of their drug, called ivonescimab, as well as other experimental therapies that target the proteins “PD-1” and “VEGF” as potential heirs to Keytruda as a backbone of lung cancer care.”
  • Per Fierce Pharma,
    • “An unfavorable overall survival trend in a phase 3 trial threatens to thwart AstraZeneca and Daiichi Sankyo’s bid to establish their star antibody-drug conjugate Enhertu as a first-line treatment for patients with HER2-mutant non-small cell lung cancer.
    • “Treatment with Enhertu showed a preliminary 15% increased risk of death compared with Keytruda plus chemotherapy in the phase 3 Destiny-Lung04 study, according to results shared at the 2026 World Conference on Lung Cancer.
    • “At an interim analysis of the study, patients in the Enhertu arm lived a median 29.3 months, versus 33.1 months in the Keytruda-chemo arm. At that point, 213 patients (46.9%) enrolled in the study had passed away, including 115 (50.7%) in the Enhertu group and 98 (43.2%) in the control arm.” 
  • and
    • “GSK is advancing its inaugural lung cancer asset, Jideytro, toward a landmark first-line FDA approval, aided by an unprecedented complete response rate.
    • “In a quick return for GSK’s $10.6 billion acquisition of Nuvalent, an early FDA nod in July has made Jideytro GSK’s first commercial lung cancer drug, with a label covering advanced ROS1-positive non-small cell lung cancer following treatment with a prior ROS1 tyrosine kinase inhibitor (TKI). Now, the company is gunning for an expansion into the TKI-naïve population. 
    • “That plan is supported by new data from the single-arm Arros-1 trial. Among 94 efficacy-evaluable TKI-naïve patients, Jideytro triggered an objective response in 88 patients (94%), according to data presented at the 2026 World Conference on Lung Cancer in Seoul. These patients were allowed to have received up to one prior line of chemotherapy with or without immunotherapy before entering the study.”
  • and
    • “Akeso and Summit Therapeutics’ ivonescimab reduced the risk of death by 27% compared with Keytruda in patients with treatment-naïve, PD-L1-positive advanced non-small cell lung cancer in the phase 3 Harmoni-2 trial conducted in China.
    • “The result, to be presented at the 2026 World Conference on Lung Cancer in Seoul, marks another positive readout from ivonescimab, whose Keytruda head-to-head win two years ago on the trial’s primary endpoint of progression-free survival sparked a gold rush for similar PD-(L)1xVEGF bispecific antibodies. 
    • “In Keytruda’s monotherapy setting, having such strong data help[s] physicians understand that this is an approach capable of beating current PD-1 standards of care in this indication,” Akeso CEO Michelle Xia, Ph.D., told Fierce.”

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

  • Beckers Payer Issues reports,
    • “Nationally, the average annual deductible for single coverage under an employer-based health insurance plan is $2,169, according to an analysis from KFF.”
  • and
    • “Nationally, the average annual deductible for family coverage under an employer-based health insurance plan is $3,997, according to an analysis from KFF.”
  • Chief Health Executive explains how Baptist Health reduced emergency room boarding in its Arkansas facilities,
    • “Predictive discharge analytics shifted discharge ordering earlier, aligning bed availability with afternoon admission surges and improving system-wide throughput and transfer capacity. 
    • “Real-time identification of modifiable discharge barriers enabled safe, prompt disposition, recapturing capacity without new brick-and-mortar and reducing ED boarding by about 525 patients per month. 
    • “A phased, two-hospital start with iterative frontline feedback built provider trust in the data, reinforcing a “work smarter” culture rather than intensifying labor demands. 
    • “Robust governance integrating physicians, nursing, IT, laboratory, radiology, and environmental services supported transparency, accountability, and sustained process redesign to maintain flow improvements.”
  • Healthcare Dive relates,
    • “Oracle Health’s clinical artificial intelligence agent is now available for nurses in the U.S., roughly two years after the tool launched first for physicians, the company announced Monday.
    • “For doctors, the AI agent works autonomously to draft clinical notes, propose follow-up lab tests and generate discharge summaries. Oracle tacked on new capabilities in August, adding chart review assistance, dictation and automated coding.
    • “The tool works similarly for nurses, but with role-specific considerations, Oracle says. Nurses can use voice commands to search for and navigate patient charts and generate nursing summaries to limit administrative work.”
  • Fierce Healthcare adds,
    • “Abridge expanded its artificial intelligence capabilities into the mid-revenue cycle workflow. The company launched a pre-bill review capability designed specifically for clinical documentation integrity (CDI), coding and revenue cycle teams.
    • “The pre-bill reviews inpatient claims before submission, comparing coded diagnoses and diagnosis-related groups (DRGs) against what the clinical documentation supports to identify potential discrepancies and provide supporting evidence, the company announced on Monday.
    • “Abridge started with ambient listening and AI-powered clinical notes and has steadily expanded beyond clinical documentation to tackle other admin tasks, developing what it calls a “clinical intelligence” platform. The company has built its platform around the clinical conversation and is expanding both upstream to support visit preparation and downstream into administrative and revenue cycle workflows.
    • “Abridge says its clinical AI technology captures the record as the clinical interactions happen and the company can extend that into reimbursement workflows. Extending that same platform into pre-bill review allows Abridge to compare the clinical record with the diagnoses and DRG on the claim and show where they do not align. CDI and coding teams can then determine before submission whether the coded record accurately reflects the documented complexity of care.”
  • The Wall Street Journal lets us know,
    • “Wegovy maker Novo Nordisk NOVO.B is rebranding as Novo, betting a shorter name will help it resonate more with consumers as it competes with rival Eli Lilly.
    • “The move by the Danish drugmaker comes as Chief Executive Mike Doustdarworks to revive the fortunes of a company that has ceded the crown in the weight-loss market it pioneered to Lilly.
    • “Since taking the reins in August last year, Doustdar has implemented a cost-savings plan that included 9,000 job cuts and the launch of a pill version of Wegovy, placing the company ahead of its U.S. rival in the market for oral weight-loss medications. Doustdar is expected to detail the next phase of his comeback plan in an investor update later this month.”
  • Medtech Dive informs us,
    • “Medtronic said Monday that it has started an exchange offer to split off up to 80.1% of the shares of MiniMed.
    • “Formerly Medtronic’s diabetes technology business, MiniMed went public in March as part of a two-step separation process. Exchanging the remainder of Medtronic’s shares is the second part of the process. Medtronic currently owns 89.9% of the company.
    • “Medtronic CEO Geoff Martha said the offer “reflects our confidence in MiniMed as an independent company, giving the diabetes company more focus and flexibility, and allowing Medtronic to focus capital on its cardiovascular, neuroscience and surgical portfolios.”

Weekend update

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Hill explains,
    • “House and Senate lawmakers will return to Washington this week with a packed agenda before much of their focus shifts to the fast-approachingmidterm elections.
    • “The Senate is expected to continue talks over the budget resolution and hold a procedural vote on the cryptocurrency regulation bill, among other priorities. The House, meanwhile, will reportedly consider a Senate-passed Russia sanctions bill prior to departing again until mid-November, after House Republican leaders recently cut two weeks from the chamber’s September schedule ahead of the midterms.”
  • MedPage Today reports,
    • “Healthy Moms, Healthy Babies America, a bipartisan campaign founded by philanthropists Olivia and Tom Walton, announced a $100 million pledge to make giving birth in the U.S. safer.
    • “The 5-year commitment aims to cut the maternal mortality rate in the U.S. in half by 2031.
    • “For millions of moms in America, maternal health is bad and getting worse,” Olivia Walton told the Associated Press in an interview. “There’s just so much bipartisan consensus around wanting to fix this. I really think the political will is there and part of our job is to help surface that with an information campaign.” * * *
    • “According to the most recent data available, the U.S. has one of the highest maternal mortality rates among wealthy nations. The CDC said 688 people died in 2024 during pregnancy or shortly after giving birth. The maternal mortality rate rose to 19 deaths per 100,000 live births in 2024, up from 18.6 the year before.
    • “Improving data collection and accelerating hospitals’ reporting of deaths is an important pillar of the new Healthy Moms, Healthy Babies America initiative, Walton said. The most recent state-level data on maternal mortality is still from 2022, with annual totals based on provisional data available through 2024.”

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

  • Per Department of War news release,
    • “The Department of War has extended and expanded the Pilot Health Insurance Enhancement for DOW Civilian Employees in Japan, reaffirming its commitment to securing high-quality healthcare navigation and mitigating upfront medical costs for its overseas civilian workforce and their families.
    • “The contract extension, awarded to International SOS Government Services, Inc., begins Sept. 30, 2026, and runs through Sept. 29, 2027. In direct response to feedback from the DOW civilians, eligibility is now expanded to include authorized dependents of DOW civilian employees, provided they are enrolled in a participating Federal Employee Health Benefit plan.” * * *
    • “The pilot program, which originally launched on Jan. 1, 2025, was designed to provide no-cost supplemental health support services to DOW civilian employees. The program addresses longstanding challenges in navigating Japan’s healthcare system and managing upfront medical costs. In response to DOW civilian employee feedback, the program previously added interpreter services to address language barriers and improve access to care.
    • “Alongside the expansion of eligibility to dependents and as part of the contract extension, the program is updating call center hours. Beginning Sept. 30, 2026, the bilingual call center will operate Monday through Friday, from 7 a.m. to 7 p.m. Japan Standard Time.
    • “To participate in the pilot, DOW civilian employees and their dependents must be enrolled in one of the following participating FEHB plans:
      • “Federal Blue Cross Blue Shield
      • “Foreign Service Benefit Plan
      • “Hawaii Medical Service Association
      • “Government Employees Health Association
      • “Mail Handlers Benefit Plan
    • “Nonappropriated Fund employees and their dependents in Japan are also eligible if enrolled in Aetna International and should coordinate support through their insurance carrier first.”

From the Food and Drug Administration front,

  • MedCity News reports,
    • “Nutromics landed FDA breakthrough device designation this week for its wearable patch that monitors vancomycin levels in real time. 
    • “Vancomycin is a widely used antibiotic for treating life-threatening infections like sepsis, but it’s notoriously difficult to dose correctly, with doctors typically relying on periodic blood draws to track it.
    • “Nutromics was founded in 2017 with the goal of replacing these blood draws with continuous data for the roughly 2.9 million patients in the U.S. who receive vancomycin each year. The new designation gives the company faster, closer engagement with the FDA as it works toward an eventual commercial launch.”

No Surprises Act News

  • On September 15, 2026, the Centers for Medicare and Medicaid Services will open its Independent Dispute Resolution Gateway to registration by non-initiating parties, typically health insurers and plans.
    • “All potential users of the IDR Gateway can begin creating accounts on September 15, 2026.
    • “Your organization should select at least one IDR Gateway administrator (CMS recommends two, and no more than 10) to set up your organization in the IDR Gateway.
    • “The Federal IDR Team will email selected administrators instructions to create their accounts and set up their organizations.
    • “If your organization selects you as an administrator and the Federal IDR Team did not email you instructions, email IDRGatewayHelp@cms.hhs.gov.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A 40-year-old Pennsylvania woman died Saturday from complications associated with measles, the local coroner said.
    • “It was the first measles-related death in Jefferson County, according to county coroner Greg Furlong. The woman was unvaccinated, Furlong said.” * * *
    • “Measles cases in the U.S. are at their highest level in three decades, with 3,924 confirmed cases so far this year, according to the Centers for Disease Control and Prevention. There were 2,289 confirmed measles cases in the U.S. last year, including the first measles-related death in a decade.
    • “The rapid spread illustrates a new normal in the U.S., where falling vaccination rates have made more communities vulnerable to the highly infectious disease that the country declared eliminated more than 25 years ago.”
  • The Washington Post relates,
    • “The number of cancer deaths estimated to be attributable to alcohol in the United States doubled from 1990 to 2023, particularly among men and people aged 55 years and older, according to a University of Miami study published this month, adding to the body of recent research underscoring the health risks of alcohol consumption.
    • “Around 23,126 people died of alcohol-attributable cancer in 2023, up from 11,361 in 1990, according to the study, which estimated the deaths using a global database of disease mortality and population-level estimates of alcohol exposure.
    • “The impact of alcohol, a known carcinogen, increased over the past decades as cancer mortality decreased overall, according to the study. 
    • “Even though overall the cancer mortality was going down for some of these cancers … alcohol-associated mortality was going up,” said Chinmay Jani, a hematology-oncology fellow at the University of Miami’s Sylvester Comprehensive Cancer Center and one of the authors of the study. “Which means that alcohol as a risk factor was impacting more cancer deaths in 2023 than it was in 1990.” * * *
    • “Gilberto Lopes, chief of the division of medical oncology at Sylvester and another author of the study, added that the data did not establish a safe threshold for alcohol consumption. 
    • “It is difficult to ascertain exactly what the safe level of alcohol is,” Lopes said. But “it is quite clear that we do know the mechanisms through which alcohol causes cancer. So that there’s no dispute about.”
  • The New York Times considers whether “Motion Sickness is Preventable?”
    • “Experts say there are ways to stave off that dreaded queasy feeling.”
  • Health Day tells us,
    • “A widely used weight-loss and diabetes drug may offer a surprising bonus: healthier lungs.
    • “Researchers compared tens of thousands of patients prescribed either a GLP-1 medication or another type of diabetes treatment to see if they helped with asthma or COPD.
    • “The results: Only one — semaglutide, the active ingredient in drugs like Ozempic and Wegovy — made a difference.
    • “It was associated with nearly 40 percent fewer asthma attacks and 20 percent fewer COPD flare-ups.
    • “No significant association was found with the other GLP-1 meds, regardless of dose or underlying lung disease.
    • “The lead researcher calls the findings encouraging but says, for now: “People with asthma or COPD should not start GLP-1 receptor agonists specifically for their lung condition outside current prescribing guidance.”
  • STAT News informs us,
    • “AstraZeneca said Friday that a breast cancer pill failed in a pivotal trial testing it as a first-line therapy in advanced tumors, a result that could limit the use of the medicine.
    • “The drug, camizestrant, in combination with another medicine did not outperform standard treatment on a measure of how long patients went before their cancer progressed. The SERENA-4 trial enrolled patients with ER-positive, HER2-negative advanced cancer who hadn’t had another systemic therapy for advanced disease.”
    • “Camizestrant earlier this month won accelerated approval in the U.S. as Etcamah as a treatment for patients who develop a mutation in their tumors that’s a sign of emerging drug resistance. The SERENA-4 trial, had it been successful, could have opened up a much larger market for the drug. 
    • “AstraZeneca is also testing camizestrant in early breast cancer.
    • “Early breast cancer represents an important opportunity, and we remain confident in the long-term potential of Etcamah in the early setting as we advance our broader program,” Susan Galbraith, AstraZeneca’s head of oncology R&D, said in a statement, adding that the company was “disappointed by the SERENA-4 outcome.”
  • The New York Times points out,
    • “Until last Friday, cardiologists thought they were on the verge of a new frontier in treating heart disease.
    • “Three companies were conducting large clinical trials on experimental drugs that slash levels of a blood protein, Lp(a), thought to cause heart attacks and stroke. Doctors were eagerly awaiting the results, hoping the drug could be as important as a statin.
    • “When Novartis, the first company to complete its trial, announced its results, late Friday afternoon, after the markets closed, cardiologists were shocked. The drug could lower Lp(a) levels by 80 percent, but it did not prevent heart attacks and strokes. It had failed.
    • “There’s something we don’t understand here,” said Dr. John Alexander, a cardiologist at Duke.
    • “Cardiologists regularly see patients who have had heart attacks even though their cholesterol and blood pressure levels are low. They do not have diabetes or obesity, and they do not smoke, either. All too often, though, they have high levels of Lp(a).”
    • “About 20 percent of Americans have elevated levels; people with the highest levels of the protein can have double or triple the risk of a heart attack.
    • “So there was no question that Lp(a) was important. A drug to lower the level of the protein, cardiologists hoped, could provide a way for these patients to protect themselves.
    • “But the failure of the Novartis study raised an uncomfortable possibility: Maybe Lp(a) is not a cause of heart disease, but instead is a marker of heart disease risk, like white hair is a mark of aging.
    • “If Lp(a) is a marker, though, what is it marking? Is there another cause of heart disease that no one has thought of?
    • “That is “the nagging question we are all pondering,” said Dr. David Maron, president of the American Society for Preventive Cardiology.”

From the U.S. healthcare business front,

  • Benefits Pro reports,
    • Executives from Aetna and its parent, CVS Health, are hoping that focusing on Aetna’s relationships with doctors will be good medicine for soaring health coverage costs.
    • Steve Nelson — an executive vice president at CVS and president of Aetna — talked about Aetna’s efforts to hold down health coverage cost increases today [September 9, 2026], in Boston, during a session at a health care conference for investors organized by Wells Fargo.
    • “Absolute health care costs are still much higher than any of us would like to see them,” Nelson said.
    • “Aetna is organizing about 2,000 different initiatives to get cost trends under control, he said.
    • “If initiatives to support relationships with the providers succeed, that should make many of the initiatives work more smoothly, Nelson said.
    • “CVS streamed audio of the call live on the web and posted a recording online.”
  • Reuters relates,
    • “GE HealthCare Technologies (GEHC.O) is ​in talks over a possible $1 ‌billion deal to buy radiopharmaceutical developer Sofie Biosciences, the Financial Times reported on ​Sunday [September 13, 2206], citing people familiar with ​the matter.
    • “A deal ⁠for Sofie, which specializes in ​radioactive chemicals used in cancer scans, ​could be announced as soon as next week, the report said.
    • “Reuters could not immediately ​verify the report. GE HealthCare ​declined to comment while Sofie Biosciences could ‌not ⁠be immediately reached for comment outside regular business hours.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Congress, Cybersecurity–

From the frontier AI / Project Glasswing front

  • Daniel Borish writes in LinkedIn,
    • “Anthropic released its fourth threat intelligence report on September 10, 2026, covering activity its Threat Intelligence team disrupted between December 2025 and August 2026. The report documents cases across seven categories of harm: cyber operations, surveillance, influence operations, conventional weapons development, biological misuse, scams and fraud, and illicit distillation. The company assigns each disrupted actor an internal designator, a Generative Threat Group (GTG) number, and publishes case studies detailing how each group used Claude models, along with indicators of compromise for other defenders to act on.
    • “The report’s central claim is not that AI created new categories of attack. Credential theft, phishing, SQL injection, and unpatched edge devices remain the entry points they have always been. What changed is who can run these attacks at what speed. Anthropic’s investigators found a suspected Russian state espionage unit, a network of financially motivated ShinyHunters affiliates, Chinese university students moonlighting in exploit research, and a lone French hacktivist all using functionally similar AI-orchestrated methodologies to run multi-victim campaigns that would previously have required coordinated teams.”
  • The Wall Street Journal reports,
    • “Artificial intelligence agents being tested by OpenAI launched a cyberattack against a popular software service two months before they hacked the AI software company Hugging Face, a new signal of the potential for advanced AI tools to slip out of human control.
    • “The attack overwhelmed maintainers of an online service for coders, called RubyGems, and forced them to shut down new account registrations as they dealt with the chaos it had caused, operators of the service said.
    • “A coalition of AI researchers said it had unearthed evidence that OpenAI agents were behind the May attack and shared its findings with The Wall Street Journal and OpenAI. The AI developer on Friday confirmed that its agents had been involved in an incident involving RubyGems.
    • “Based on our review, our agents used the RubyGems platform to access the internet to carry out benign tasks and retrieve public information. We’ll continue to investigate as part of our broader review of agent activity during training and evaluation,” an OpenAI spokeswoman said in a statement.”
  • and
    • “An Anthropic researcher is quitting the artificial-intelligence industry over fears that the lab and its competitors are racing to build systems they won’t be able to control, a sign of mounting safety concerns within top AI companies.
    • “Jacob Coxon, a researcher who specializes in training new AI models by having them consume vast amounts of data, said Tuesday that he is leaving the company because he doesn’t want to participate in an industrywide rush to build AI systems that can improve themselves, worried such systems could spiral out of control and destroy humanity.
    • “The 27-year old Brit, who previously studied mathematics, said many of his industry colleagues now use phrases like “crunchtime” and “endgame” to describe the trajectory toward self-improving models.” * * *
    • “Anthropic didn’t immediately comment on the departure. Chief Executive Dario Amodei and other company leaders have repeatedly warned about the risks of rogue AI models, and urged the industry to slow development. 
    • “After Coxon announced his departure, a top scientist at the company, Evan Hubinger, wrote on X that he thought Coxon was correct about the risks of AI development.
    • “We really do earnestly believe AI could kill all humans! I personally think it is >10% within the next decade,” Hubinger wrote. “I believe Anthropic is trying its best, but we do not yet have a plan to solve alignment for superintelligence and are not clearly on track to.” Others also amplified the view.”
  • Per Axios: “Nvidia CEO Jensen Huang: AI fears designed to generate cybersecurity business.”
  • BigGo Finance lets us know,
    • “A bipartisan group of US senators is negotiating legislation that would create a legal duty of care for frontier AI developers, requiring them to prevent catastrophic risks and giving the federal government authority to block unsafe model releases. The proposal, led by John Thune, Ted Cruz and Amy Klobuchar, would apply to advanced models from companies such as OpenAI, Anthropic and Google, with national laboratory experts potentially conducting hands-on testing for nuclear, biological and cyber threats. Companies could appeal government blocking decisions in federal court. The measure would also preempt state AI safety laws. With the House in session only one week before the November 3 midterms, passage remains uncertain despite growing pressure on Congress to address frontier AI risks.”
  • Axios adds,
    • “A letter is circulating among House members urging Speaker Mike Johnson (R-La.) to bring back the House “immediately” and keep it in session until Congress passes AI safeguards, Axios has learned.”
  • The Wall Street Journal notes,
    • “President Trump, who has taken a light touch overseeing the sector, previously said he is in favor of kill switches and other steps to keep AI safe but has warned burdensome regulation could cost the U.S. in the tech race.”
  • and
    • “The leaders of three of the biggest AI companies agreed [September 12] that they needed to slow development of the technology before their advances create a menace that can’t be controlled.
    • “It was a rare display of unity by Elon Musk, Sam Altman and Dario Amodei, who have been spending tens of billions of dollars to develop evermore powerful artificial intelligence models. Altman even suggested that his company, OpenAI, may need to delay its much-anticipated IPO to focus on safety.”

From the cybersecurity policy and law enforcement front,

  • Per GovCIO Media,
    • “Federal agencies are looking to deepen their partnership with the private sector to protect critical infrastructure, with joint efforts to identify vulnerabilities, deploy technology and scale solutions.
    • “National Cyber Director Sean Cairncross said Thursday [September 10] at the Billington Cybersecurity Summit in Washington that government and industry need to work “hand in glove” rather than rely on compliance checklists as technology increasingly shapes both critical infrastructure and the threats against it.
    • “We’re in a moment technologically where security and innovation have melded, and in order to move forward, protect critical infrastructure, make sure the systems that our citizens rely on for daily life are protected and secure, we need a relationship that is hand in glove, and that means we cannot be dictating a compliance checklist to industry,” said Cairncross.”
  • Federal News Network reports,
    • “The FBI released its first agency-wide, unclassified cyber strategy on Wednesday, with the goal of unifying efforts across the bureau’s 56 field offices to counter both nation-state threats and cyber criminals.
    • “The 17-page strategy details a four-pillar approach to countering cyber threats across the bureau. Brett Leatherman, assistant director of the FBI’s Cyber Division, said previous cyber strategies for the bureau have either been classified or focused on specific threats, like countering China.
    • “This is a comprehensive strategy that directs our teams, our field offices, our global presence, and how we are to align all our efforts to counter this work,” Leatherman told reporters after speaking at the Billington Cybersecurity Summit in Washington on Wednesday morning [September 9].”
  • and
    • “The CIA is pushing to bring more scientific and technical expertise into its workforce, with a top official touting a big year for hiring despite widespread cuts across the intelligence community over the past year.
    • “Michael Ellis, the deputy director of the CIA, said the spy agency is seeking to recruit more employees with backgrounds in science and technology. Ellis described a STEM background as not a prerequisite for intelligence in work in 2026, but “it sure helps make things easier.”
    • “When I think about, you know, where we want the CIA workforce to be five years from now, it’s an elite workforce,” Ellis said at the Billington Cybersecurity Summit in Washington on Tuesday. “It’s a nimble workforce. It’s one that has more technical background than it has today, and it’s one that is motivated by mission.”
  • Cybersecurity Dive adds,
    • “As the federal government scrambles to protect its own networks and support critical infrastructure operators, CISA is preparing to bring in roughly 250 new employees to rebuild core teams.
    • “We’re looking forward to welcoming hundreds of new CISA employees in the very near future,” acting CISA Director Nick Andersen told reporters after a talk at the Billington Cybersecurity Summit here on Wednesday.
    • “The employees have received tentative job offers and are “waiting to get that official start date,” Andersen said during his speech.”
  • Cyberscoop points out,
    • “The private sector still isn’t sharing enough cyber information with the FBI in part because organizations are operating on false assumptions about what the bureau will do with what it collects, the FBI’s top cyber official said Wednesday.
    • “Brett Leatherman, assistant director of the FBI’s cyber division, said in remarks at the Billington CyberSecurity Summit and in a discussion with reporters that organizations stand to benefit from bringing in the bureau when it’s compromised by hackers from the People’s Republic of China (PRC) and others. But one of the “key misconceptions” is that “the FBI is somehow sharing information with regulators for regulatory purposes, and that’s not the case.”
    • “From my standpoint over the last few years, I think we’ve seen a hesitancy on some companies to engage [with the] FBI,” Leatherman said.”
  • and
    • “The U.S. government is accusing Chinese AI companies of engaging in a deliberate and “systematic” effort to illegally distill U.S. frontier AI models and their capabilities. 
    • “According to a joint cybersecurity advisory from the National Security Agency, the Cybersecurity and Infrastructure Security Agency and the FBI, the sheer scale of these efforts since 2024 indicate that distillation is a critical part of China’s AI industrial policy.
    • “China-based artificial intelligence companies are conducting systematic extraction of proprietary functionalities and capabilities of U.S. AI companies’ models through industrial-scale knowledge distillation campaigns that form the core—not merely a supplement—of their AI development strategy,” the agencies wrote. 
    • “The advisory names Chinese companies like DeepSeek, Moonshot AI, Alibaba, MiniMax, StepFun, and Z.AI, saying they spent billions of tokens across millions of exchanges and requests with frontier U.S. AI models like Anthropic’s Claude, OpenAI’s ChatGPT, Google Gemini, and xAI’s Grok, since at least late 2024.”
  • The Justice Department made available “Remarks by Deputy Assistant Attorney General Josh Goldfoot of the Justice Department’s Criminal Division at the International Symposium on Cybercrime Response” held in Seoul, Korea.
  • Beckers Health IT notes,
    • “A Ukrainian national who helped deploy Conti ransomware against more than 1,000 victims worldwide has been sentenced to four years in prison for conspiracy to commit wire fraud.
    • “Oleksii Oleksiyovych Lytvynenko, 44, formerly of Cork, Ireland, admitted to joining the Conti operation and coding a “loader” — malware used to deliver other malicious software onto compromised systems, according to a Sept. 10 U.S. Justice Department news release. He pleadedguilty June 10.
    • “Conti attacked computers and networks in 47 states, the District of Columbia, Puerto Rico and 31 countries between 2020 and 2022, and the FBI estimates the group collected more than $150 million in ransom payments. Evidence from Mr. Lytvynenko’s online accounts showed he possessed data stolen from eight U.S. victims and four overseas victims. He was arrested in County Cork, Ireland, in July 2023.”

From the cybersecurity breaches and vulnerabilities front,

  • HIPAA Journal released its June 2026 Healthcare Data Breach Report.
    • “In June 2026, 66 large healthcare data breaches – data breaches involving the protected health information of 500 or more individuals – were reported to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) – a slight increase from the 64 data breaches reported in May. More than two large data breaches a day is the new normal. Over the past 12 months, an average of 65 large healthcare data breaches have been reported per day; eight years ago in 2018, large healthcare data breaches occurred at a rate of around one per day.”
  • Beckers Health IT reports,
    • “Houston-based Nutex Health says the hackers behind its August cyberattack have published the data they allegedly stole on their own website.
    • “The publicly traded micro-hospital operator is now downloading, processing and analyzing that data to determine its contents, scope and authenticity, according to a Sept. 10 SEC filing. Nutex said the review could take several weeks given the volume of data involved.” * * *
    • “Nutex said it has not identified any material impact on its business operations or financial reporting systems, and its materiality assessment from the Aug. 31 filing remains unchanged. The company said it continues to evaluate regulatory and legal notification requirements and intends to notify affected patients and employees.
    • “Several purported class action lawsuits have been filed against Nutex in the U.S. District Court for the Southern District of Texas’ Houston Division on behalf of individuals whose personal or health information was allegedly accessed. Nutex said it cannot predict the litigation’s outcome or its potential financial impact.”
  • and
    • “Annapolis, Md.-based Luminis Health’s phone system and MyChart patient portal remain unavailable as the health system continues responding to a cybersecurity incident involving an unauthorized criminal actor.
    • “In a Sept. 10 update, Luminis Health said its investigation is ongoing and teams are working with third-party experts to safely restore affected systems.
    • “The health system said its hospitals remain open and continue providing patient care.”
  • and
    • Recent cybersecurity warnings and incidents are highlighting risks for healthcare organizations that extend beyond ransomware, including cloud authorization abuse, voice phishing, brand impersonation, third-party access and publicly exposed information.
    • [The article describes] five recent cybersecurity developments Becker’s has reported on in September.]
  • Security Week adds,
    • “More than 4.1 million individuals had their personal, health, and insurance information stolen in a data breach at healthcare company AdaptHealth.
    • “Operating over 680 facilities across the US, AdaptHealth describes itself as a network of medical equipment companies that provides patients with healthcare solutions and medical equipment.
    • “The company was hacked in early June, when a threat actor gained access to its cloud-based applications, including internal systems used for patient management and document storage.
    • “After the attacker contacted the company, it confirmed the data breach, including the theft of a password file associated with insurance billing.
    • “The hacker used social engineering to compromise a user session at a third-party contractor, AdaptHealth said.”
  • and
    • “Future phishing campaigns may no longer involve a detectable physical web page.
    • “Barracuda has analyzed a new type of phishing campaign that adds both stealth and flexibility to traditional phishing. Rather than standard social engineering to persuade a target to visit a static compromised web page, this campaign generates a blob URL to render and deliver the phishing page inside the target’s own browser. This reduces the possibility of security scanners detecting either the social engineering email or the static residence of the phishing page.”
  • HIPAA Journal lets us know,
    • “Three high-severity vulnerabilities have been identified in NextGen Healthcare Mirth Connect (Mirth Connect), a cross-platform healthcare integration engine for connecting, routing, transforming, and exchanging clinical and administrative data between different healthcare systems. The vulnerabilities are due to improper neutralization of special elements used in SQL commands and improper restriction of XML External Entity Reference. Successful exploitation of the vulnerabilities could allow denial-of-service attacks and data exfiltration.
    • “The vulnerabilities were identified by security researcher Abhinav Agarwal using autonomous agents running his published methodology on AI-assisted vulnerability discovery. “Mirth Connect is effectively a switchboard between healthcare systems. It can sit between lab systems, imaging systems, databases, and clinical applications, so a vulnerability in the integration layer can expose much more than one isolated application,” Agarwal told The HIPAA Journal. A potential problem is that healthcare organizations may not know that they have a vulnerable component in one of their products. “A hospital may not see the name Mirth anywhere on the product it bought. Integration software can be managed, resold, or embedded inside another product, which is why SBOMs and exact version disclosure matter after vulnerabilities like these,” explained Agarwal.”
  • CISA added 14 known exploited vulnerabilities to its catalog this week.
    • September 8, 2026
      • CVE-2026-75650 Adobe Commerce and Magento Improper Neutralization of Special Elements Used in a Template Engine Vulnerability
      • CVE-2026-81963 Microsoft Windows Link Following Vulnerability  
      • CVE-2026-85880 Microsoft Windows Heap-Based Buffer Overflow Vulnerability 
      • CVE-2026-86218 N-able N-central Static Code Injection Vulnerability
        • SOC Prime discusses the Adobe KVE here.
        • The Hacker News discusses the Microsoft KVEs here.
        • Cybersecurity Dive discusses the N-able KVE here. 
    • September 9, 2026
      • CVE-2025-25249 Fortinet Multiple Products Heap-based Buffer Overflow Vulnerability
      • CVE-2026-19490 Citrix NetScaler Authentication Bypass Using an Alternate Path or Channel Vulnerability
      • CVE-2026-87491 Google Chromium V8 Out of Bounds Write Vulnerability
      • CVE-2026-20079 Cisco Firewall Management Center Authentication Bypass Using an Alternate Path or Channel Vulnerability 
        • Security Week discusses the Fortinet KVE here.
        • Cybersecurity News discusses the Citrix KVE here.
        • SOC Prime discusses the Google KVE here.
        • The Cybersecurity Hub discusses the Cisco KVE here.
    • September 10, 2026
      • CVE-2026-67277 MikroTik RouterOS Missing Authentication for Critical Function Vulnerability
      • CVE-2026-86060 MikroTik RouterOS Improper Neutralization of Argument Delimiters in a Command Vulnerability
        • Bleeping Computer discusses these KVEs here.
    • September 11, 2026 (1)
      • CVE-2026-42016 JFrog Artifactory Incorrect Authorization Vulnerability 
      • CVE-2026-42018 JFrog Artifactory Improper Authentication Vulnerability 
      • CVE-2026-84869 ConnectWise ScreenConnect Improper Privilege Management and Missing Authorization Vulnerability
        • The Hacker News discusses the JFrog KVEs here.
        • Security Arsenal discusses the ConnectWise KVE here.
    • September 11, 2026 (2)
      • CVE-2026-85706. GitLab Community Edition and Enterprise Edition Path Traversal Vulnerability
        • Cyberscoop discusses this KVE here.
  • Dark Reading adds,
    • “A new analysis of public data from Anthropic’s Project Glasswing has highlighted a significant gap between the number of vulnerability findings generated by its Claude frontier model and those that ultimately prove to be real, serious, and worth fixing.
    • “The distinction matters because it suggests that the bottleneck in vulnerability research may increasingly lie in validating new flaws and coordinating their remediation rather than in discovering them.”
  • Security Week tells us,
    • “Anthropic disrupted a cyberespionage operation whose tradecraft and targeting match the Russian state-nexus group tracked as Midnight Blizzard, the company said in a threat intelligence report published this week. 
    • “The report covers activity the company identified and shut down between December 2025 and August 2026.
    • “According to Anthropic, Midnight Blizzard used Claude to monitor how well its malware evaded detection by security products. When a tool was flagged, AI agents automatically modified and rebuilt it, then redeployed it, repeating the process until the malware went undetected again.”

From the ransomware front,

  • The Hacker News reports,
    • “Cisco has revealed that three distinct threat clusters linked to ransomware and state-sponsored attacks have been exploiting two recently patched Secure Firewall Management Center (FMC) vulnerabilities.
    • “The attacks leverage CVE-2026-20079 (CVSS score: 10.0), an authentication bypass vulnerability in the web interface of FMC software that could allow an unauthenticated, remote attacker to bypass authentication and execute script files on an affected device to obtain root access to the underlying operating system.
    • “The second flaw under exploitation is CVE-2026-20316 (CVSS score: 5.3), which could allow an unauthenticated, remote attacker to log in to an affected device using a low-privilege account to access sensitive data within susceptible systems. It can be paired with other Cisco Secure FMC vulnerabilities to elevate privileges.” * * *
  • Cybersecurity Insiders relates,
    • “Ransomware attacks are becoming increasingly common, posing a serious threat to businesses across industries. A recent study conducted by Object First in collaboration with technology research firm Omdia highlights not only the growing frequency of these attacks, but also the increasing difficulty businesses face in recovering their data after an incident.
    • “According to the study, ransomware is having a significant impact on business operations. Over the past 24 months, around 84 percent of businesses surveyed admitted that file-encrypting malware had severely disrupted their operations. This represents a considerable increase from the previous year, when only 64 percent of businesses reported experiencing such disruption.
    • “The findings become even more concerning when it comes to data recovery. Only 39 percent of ransomware victims said they were able to recover at least 80 percent of their data following an attack. This is a sharp decline from the 57 percent reported the previous year. The figures indicate that businesses are not only encountering ransomware more frequently but are also finding it increasingly difficult to restore their systems and recover critical information.” * * *
    • “The decline in successful data recovery also highlights the importance of preparedness. Simply preventing an attack is no longer enough. Organizations need comprehensive backup and recovery strategies that can help them restore critical systems quickly in the event of a successful breach. Regularly tested backups, robust access controls, employee awareness training and well-defined incident-response plans can all play an important role in reducing the damage caused by ransomware.
    • “The latest findings suggest that ransomware has evolved into a broader business continuity challenge. As attacks become more frequent and sophisticated, organizations must focus equally on prevention, detection and recovery. Investing in resilient infrastructure and reliable data protection could prove crucial in ensuring that a ransomware incident does not turn into a prolonged business crisis.”
  • Help Net Security adds,
    • “In this Help Net Security video, Kerri Shafer-Page, VP of Incident Response at Arctic Wolf, walks through the ransomware decision tree in this video. She covers four areas where decisions need settling in advance, starting with containment.
    • “Someone has to know the network well enough to judge what pulling a system offline does to client data, a manufacturing line, or a website. Then comes the extortion demand. Who is authorized to negotiate, and what is the ceiling?
    • “Shafer-Page treats paying as a business decision, noting that a demand can cost less than an insurance retention and higher renewal rates. She argues law enforcement belongs in the playbook, since agencies may know the threat actor and can help you avoid sanctions problems.
    • “Communication matters too, from cyber legal counsel on disclosure deadlines to a spokesperson and a prepared help desk. Her advice: make these decisions on a Tuesday afternoon, not at 2 a.m. on a holiday weekend.”
  • and
    • “In this Help Net Security video, Dave Ross, Senior Director of the Intelligence Fusion Team at Intel 471, explains what happens behind the scenes during ransomware negotiations.
    • “Ross walks through the tactics groups use once an attack begins, from research on a victim’s revenue and insurance coverage to test decryptions that prove they hold a working key.
    • “He describes how demands are often set at roughly 1% to 5% of annual revenue, why deadlines move depending on how a victim responds, and how some groups split work between researchers, negotiators, and staff who apply public pressure.”

From the cybersecurity business and defenses front,

  • Cryptobriefing reports,
    • “Tenable Holdings is embedding Anthropic’s Claude Mythos 5 directly into its flagship cybersecurity product, betting that frontier AI models can fundamentally change how organizations spot and neutralize threats before attackers exploit them.
    • “The integration, announced on September 8, 2026, will bring AI-driven exposure analysis and attack-path discovery into the Tenable One Exposure Management Platform. The first concrete feature shipping under this effort is called Tenable One Adversary View, which uses Claude Mythos 5 to reconstruct how an attacker could move from an initial foothold all the way to an organization’s most critical systems.”
  • Per MedTech Dive,
    • “Boston Scientific disclosed Tuesday the cyberattack that recently hit the company is likely to affect third-quarter and full-year results.
    • “The medical device maker believes it is unlikely to meet net sales growth and adjusted earnings per share guidance ranges provided in July for the third quarter and full year, according to a new filing with the Securities and Exchange Commission.
    • “The Company anticipates recovering some portion of the impacted revenue as it continues to ramp operations globally, fulfill customer orders and reduce remaining backlogs, however the full impacts are not yet known,” Boston Scientific said in the filing.”
  • Cybersecurity Dive relates,
    • “After suffering a series of high-profile cyberattacks over the past decade, Microsoft says a new initiative to reinvigorate its security culture is bearing fruit.”
  • and
    • “Chief information security officers are largely expected to ensure the security of AI across the enterprise, but many say they are not receiving adequate support, according to findings from Proofpoint. 
    • “About 85% of CISOs said ensuring the safe use of AI assistants, copilots and automation is a top priority over the next two years, according to Proofpoint’s annual Voice of the CISO report. Eight of every 10 CISOs said they are expected to manage AI-related security risks without receiving a proportional increase in resources or expertise. 
    • “CISOs have a significant role to play in securing AI adoption, but they can’t own the risk alone,” Patrick Joyce, global resident CISO at Proofpoint, told Cybersecurity Dive. “AI is being adopted across the business, often faster than traditional governance models can keep up.”
  • and
    • “Advances in artificial intelligence aren’t changing the fact that simple cybersecurity failures remain the most consequential, government and industry leaders warned on Tuesday.
    • “What will prevent the attacks in the next 18 months are the same things that would have prevented the attacks of yesterday,” Jason Bilnoski, a deputy assistant director in the FBI’s Cyber Division, said during a panel here at the Billington Cybersecurity Summit.
    • “Core practices such as identity management, perimeter monitoring, cyber hygiene and strong multifactor authentication remain as essential as ever, Bilnoski said.
    • “Speed and capability is certainly increasing with the use of AI, but the end state is still the same,” he said. “How actors are compromising, whether it’s criminal or nation-state, still stays the same.”
  • HIPAA Journal tells us,
    • “The HHS has released an updated version of the Security Risk Assessment (SRA) Tool (v3.7). The tool is ideally suited for small- and medium-sized entities to guide them through the risk analysis process, help them identify risks and vulnerabilities to electronic protected health information (ePHI), and comply with the risk analysis implementation specification of the Security Management Process standard of the HIPAA Security Rule.”
  • CISA has released the 2026 edition of its Insider Threat Mitigation Guide.
    • “The Cybersecurity and Infrastructure Security Agency’s Insider Threat Mitigation Guide aids critical infrastructure stakeholders in comprehending the concept of insider threats, identifying the various forms these threats can take, and implementing best practices to establish or enhance an insider threat mitigation program. Such a program is essential for protecting critical assets, deterring violence, countering unintentional incidents, preventing loss of revenue or intellectual property, averting the compromise of sensitive data, and ultimately saving lives.”
  • Healthcare IT News informs us,
    • “Devices and sensors that collect heart rate and other health data and rely on applications to share information with third parties pose serious questions about data protection for patients and the health systems that care for them.
    • “While smart ring and watch data might help doctors treat patients, security experts say low security standards in consumer tech and improperly configured APIs present potential security risks for providers.
    • “Hackers can exploit such flaws, using consumer devices as entry points to breach receiving electronic health record systems and access centralized databases.
    • “To mitigate these threats, security experts say healthcare organizations must establish strict security protocols, including mandatory transit encryption, multi-factor authentication and account monitoring. They recommend zero-trust approaches to catch rogue traffic and implementation of rigorous engineering frameworks.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Never forget.

The New York Times reports

  • “Mourners and dignitaries gathered this morning in Lower Manhattan to honor the thousands of people who were killed on this day 25 years ago, when terrorists crashed two airplanes into the World Trade Center, shaking America and the world. It took four hours for family members of the victims to read aloud the names of all of the nearly 3,000 people who lost their lives: Gordon M. Aamoth Jr.; Edelmiro Abad; Marie Rose Abad …
  • “Solemn ceremonies were also held at the Pentagon and in Shanksville, Pa., where the other hijacked planes crashed. At the Pentagon, President Trump spoke of American resilience: “Sept. 11 reminded us of the terrible power of hate,” he said. “The 25 years since have shown us the even greater power of the American spirit to endure and prevail and to win.”
  • “All four other living presidents attended the memorial in New York. Zohran Mamdani, the city’s first Muslim mayor, was also in attendance, despite a petition signed by thousands of people, including the family members of some victims, urging him to stay away.
  • “That ceremony began, as always, at 8:46 a.m., with a beat of silence honoring the moment when the first plane, American Airlines Flight 11, struck the North Tower. Five more silences marked the times when other flights crashed and buildings fell. But this year, a new, seventh moment of silence was observed, to mourn those who have died from cancer and other illnesses inflicted by the toxic dust they inhaled after the attacks.”

From Washington, DC,

  • Tammy Flanagan, writing in Govexec, tells us,
    • Every year, the anniversary of Sept. 11, 2001, brings back the same difficult truth: federal service is not always performed behind a desk, and risk does not always announce itself in advance. Sixty-nine federal employees were among those who died that day — including 62 at the Pentagon, three at the World Trade Center, three aboard Flight 93, one aboard Flight 77 at the Pentagon and one aboard Flight 175 at the World Trade Center. Many more reported for duty afterward to secure facilities, investigate the attacks, transport people, provide emergency assistance and help the country recover.
    • For their families, the lesson is not only one of remembrance. It is also a benefits lesson. If a civilian federal employee is injured, develops an occupational illness or dies because of federal employment, the Federal Employees’ Compensation Act may provide important protection.
    • FECA is the federal government’s workers’ compensation program for civilian employees, administered by the Labor Department’s Office of Workers’ Compensation Programs. It can pay for medical treatment, replace part of lost wages, provide compensation for permanent impairment and, in fatal cases, provide benefits to eligible survivors.
    • This is where many employees and families get into trouble: They know there are “benefits,” but they do not know which benefit applies, who administers it or what evidence is needed. A traumatic injury is generally tied to a specific incident during one workday or shift and is reported on Form CA-1. An occupational disease or illness develops over more than one workday or shift and is reported on Form CA-2. Wage-loss compensation is generally claimed separately, often with Form CA-7.
    • These distinctions are more than paperwork. They affect deadlines, agency responsibilities, medical documentation and how the claim is developed.
  • FEHBlog observation: While OWCP pays benefits before FEHB /PSHB plans for OWCP compensable illnesses and injuries, OWCP does not give the beneficiary an OWCP benefits ID card which would put the provider on notice to bill OWCP, not the FEHB/PSHB plan.
  • Healthcare Dive reports,
    • “The number of hospitals complying with price transparency rules is increasing. But more than half of facilities still aren’t posting full information about the cost of their services, according to the latest analysis from PatientRightsAdvocate.org.
    • “About 51% of U.S. hospitals aren’t fully complying with the rules, despite them taking effect more than half a decade ago, according to the patient advocacy group’s latest scorecard of 2,000 hospitals.
    • “Still, the roughly 49% of hospitals in compliance is up significantly from the last time PRA analyzed the industry in 2024, and is the highest rate since the group began tracking the issue in 2021. PRA chalked the improvement up to regulators stepping up enforcement.”
  • AHIP adds,
    • “Hospital spending makes up the largest share (40%) of health insurance premiums and continues to grow, now exceeding $1.6 trillion annually. One major driver of high hospital costs is that routine services are often reimbursed at substantially higher prices — sometimes up to 13 times more — in hospital outpatient departments (HOPDs) than in physician offices and other non-facility settings, even though the care is the same.” 
  • Beckers ASC Review tells us,
    • “Physician assistants and advanced practice registered nurses can now order every noninvasive colorectal cancer screening test Medicare covers, ending a long-standing physician-only requirement under a CMS coverage change.
    • “CMS authorized the expanded coverage in June when it finalized a decision memo revising the “Screening for Colorectal Cancer — Non-Invasive Biomarker Tests” national coverage determination, the American Academy of Physician Associates said in a Sept. 10 news release.
    • “The determination previously covered the tests only when a physician ordered them. CMS reopened it after new evidence emerged on stool-based RNA tests.
    • “PAs and APRNs may now order RNA-based stool tests, DNA-based stool tests, DNA-based blood tests and fecal occult blood tests.”
  • Beckers Hospital Review informs us,
    • “Johnson & Johnson will require 340B covered entities to submit claims-level data for its covered outpatient drugs starting Sept. 15, according to a notice the drugmaker sent to providers Sept. 4.
    • “Covered entities that don’t submit will receive at least two noncompliance notices and a notice of pricing suspension, with suspension beginning at least five business days after the final notice. J&J said 340B pricing will be restored within 10 business days once a covered entity submits compliant data.
    • “The policy applies to all covered entity types regardless of dispensing or administration location, inventory management system or payer coverage. J&J said it will continue to offer 340B pricing upfront at the time of purchase rather than moving to a rebate model, and that the policy supersedes claims-data provisions in a prior notice from February 2023.
    • “Covered entities must submit data within 45 days of a drug’s dispensation; a list of oncology, autoimmune and other specialty drugs, including Stelara, Darzalex and Tremfya, carries a 60-day window.” 

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

  • Federal New Network offers an interview with OPM Director Scott Kupor, and further reports
    • “Federal employees’ performance ratings will now be the top consideration during future reductions in force, as a final rule from the Office of Personnel Management takes full force this month.
    • “OPM’s final regulations, which became effective Sept. 2, mark a significant turning point in the way agencies develop RIF retention registers, which determine whether employees are retained, reassigned, demoted or separated during RIFs.
    • “Following the publication of the final rule in August, OPM detailed further expectations about the new system in guidance to agencies. During any future RIFs, agencies will have to rank employees using a point system directly tied to their performance ratings. An employee with a level 5 performance rating will receive seven points on the RIF register, while level 4 receives five points; level 3 receives three points; and levels 1 and 2 each receive zero points.
    • “Agencies will also place competitive service and excepted service employees on separate retention registers in any future RIFs. Within each list, employees will then be numerically ranked based on their performance levels, with points added for veterans’ preference. Tenure and seniority will be used only as tiebreakers between employees.”

From the Food and Drug Administration front,

  • The Pharmacy Times reports,
    • “The FDA approved leniolisib (Joenja; Pharming Healthcare) tablets for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 to 11 years who weigh at least 27 kg. The decision makes leniolisib the first FDA-approved treatment for children in this age and weight group with the rare genetic immune disorder.”
  • Cardiovascular Business relates,
    • “Emboline, a California-based medtech company, has received U.S. Food and Drug Administration (FDA) approval for its Emboliner Embolic Protection System. The device was built to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) procedures. This is seen as a way to reduce the risk of stroke, which clinicians have been battling since TAVR was first introduced, as well as other potential complications.
    • “We developed the Emboliner to address important unmet needs with existing embolic protection approaches for TAVR,” Scott Russell, president and CEO of Emboline, said in a statement. “We are excited to now be able to put the Emboliner in the hands of physicians so that they can offer a more comprehensive embolic protection solution for their patients. We are grateful to the clinical investigators whose partnership and feedback helped us reach this point.”
    • “The Emboliner device includes a self-expanding filter that covers all three cerebral vessels. The filter’s double-layer mesh captures debris without restricting blood flow in any way.
    • “Emboline plans on beginning its commercial launch of the newly approved device by the end of 2026.”
  • Fierce Pharma tells us,
    • “The FDA has delayed its approval decision for Exelixis’ oral kinase inhibitor zanzalintinib in combination with Roche’s Tecentriq for the treatment of patients with metastatic colorectal cancer (mCRC). 
    • “Exelixis explained in a Securities and Exchange Commission filing that the agency has asked for the extension while it awaits updated safety and efficacy data from the company. It means the biopharma should now expect a decision in March 2027 as opposed to the previous deadline of Dec. 3, 2026.”

No Surprises Act News

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury have added Physio Solutions, LLC as a new independent dispute resolution entity increasing the total to 17. IDR arbitrators help make payment determinations in disputes between providers, group health plans and health insurance issuers under the No Surprises Act.”
  • Beckers Payer Issues summarizes five other recent NSA updates for us.

From the judicial front,

  • Bloomberg Law reports,
    • “A federal judge blocked the Trump administration’s use of a question for federal job applicants that critics said amounted to a test of their political beliefs. 
    • “The Trump administration can no longer require thousands of government job seekers to say why the president’s policies are personally significant to them, and how they would further them if hired, according to a Friday ruling in the US District Court for the District of Massachusetts.” * * *
    • “While the ruling prevents the administration from using the question on job applications, O’Toole denied the unions’ request for a broader preliminary injunction barring the government from incorporating applicants’ answers or non-answers into hiring decisions. 
    • The case is AFGE v. Kupor, Office of Personnel Management, D. Mass., 25-13305-GAO, 9/11/26

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 11, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP adds,
    • “The number of confirmed US cases of measles has reached 3,294, fully 1,000 more than all of last year, the Centers for Disease Control and Prevention (CDC) noted in its weekly update today. 
    • “The total includes 160 new cases, most of them in Pennsylvania, the nation’s measles hot spot. The country has now seen five straight weeks of triple-digit increases.”* * *
    • “As noted in the data from the CDC map, cases in Wisconsin are also ramping up. In an update today, the Wisconsin Department of Health Services (DHS) confirmed 163 cases across the state so far this year. Four cases are new since September 8.” * * *
    • “Ohio this week confirmed 11 new cases, 133 total. In good news, Utah, which was a measles hot spot earlier this year, has gone more than three weeks without a confirmed case. Its case count stands at 518.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention Sept. 10 released an advisory on a nationwide increase of reported human exposures to rabid or possibly rabid animals and rabies post-exposure prophylaxis administration errors. The CDC said it received 17% more rabies-related inquiries from July through August this year — including reports of mass exposure events — compared to the same period in 2025. The agency said that weekly pharmacy data as of Sept. 2 showed that utilization for the two rabies vaccines and two rabies immunoglobulins licensed in the U.S. increased by an estimated 33% and 76%, respectively, compared with the same period last year. The advisory includes recommendations for clinicians and healthcare facilities on rabies treatment and appropriate rabies PEP assessment and administration.”
  • The Wall Street Journal informs us,
    • “Public-health officials declared an end to a cyclosporiasis outbreak linked to iceberg lettuce that spread across the U.S. this summer.
    • “The outbreak has resulted in a total of 12,883 reported cases of the gastrointestinal food-borne illness across 21 states, the Centers for Disease Control and Prevention said Friday.
    • “Federal health officials have linked the outbreak to shredded iceberg lettuce from Taylor Farms, a major supplier of fresh produce to retailers such as Walmart, Costco Wholesale and Amazon.com’s Whole Foods Market, as well as restaurant chains including McDonald’s and Yum Brands’ Taco Bell.
    • “The CDC said the contaminated lettuce linked to the outbreak is no longer available in stores or restaurants, and the products’ best-by dates have passed. Recent infections linked to the outbreak have declined, with fewer than two infections per day on average in August compared to a peak of more than 1,000 daily infections, the CDC said.”
  • Health Day points out,
    • “Talking to a counselor before major surgery might boost seniors’ recovery following a procedure, a new study says.
    • “Mental health coaching before surgery can help reduce seniors’ risk of post-surgery anxiety and depression, researchers reported Sept. 9 in JAMA Network Open.
    • “The time around surgery is a window of both risk and opportunity,” lead researcher Joanna Abraham said in a news release.
    • “The stress of surgery can worsen anxiety and depression symptoms and affect patients’ recovery and overall health, but it also offers a critical opportunity to identify these concerns proactively and connect patients with the support they need,” said Abraham, a professor of anesthesiology at Washington University School of Medicine in St. Louis.”
  • Nature notes,
    • “Injected vaccines can raise an army of antibodies in the blood to stave off major illness, but don’t prevent infection at the points where respiratory viruses enter the body. Researchers hope that nasal vaccines could bolster protection at the moist mucosal barriers that line the respiratory tract, which could enable a person to rapidly ward off pathogens and prevent them from spreading a virus to others. A long line of failures demonstrates that developing a mucosal vaccine is a challenging task, but their promise is still enough to maintain commercial interest.”
  • Per Beckers Clinical Leadership,
    • “The rise of GLP-1 medications is one of the most consequential changes in obesity care in decades. Not surprisingly, bariatric surgery is feeling the impact. As patients gain access to powerful medications such as semaglutide and tirzepatide, fewer are immediately choosing an operation. The trend is real, but [as explained in the article,] the conclusion that GLP-1s will simply replace bariatric surgery misses the larger story.”

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

  • Beckers Hospital Review reports,
    • “Septicemia is the most expensive condition treated in hospitals, amounting to $60 billion in annual costs, a Healthcare Cost and Utilization Project report found. 
    • “The report, published February 2026, used 2022 data from the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project on hospital costs of inpatient stays in nonfederal acute care hospitals. Using the 2022 HCUP National Inpatient Sample, the report found the distribution of costs by primary expected payer and the conditions that accounted for the largest percentage of payer’s hospital costs. Hospital charges were converted to costs using HCUP cost-to-charge ratios. Payers included Medicare, Medicaid, private insurance and self-pay/no charge. 
    • “The report found: 
      • “The aggregate hospital costs for 32.9 million hospital stays totaled $548.5 billion.
      • “The 20 most expensive conditions account for 46.8% of aggregate hospital costs in 2022, and amounted to 43.1% of all hospital stays.
      • “Septicemia accounted for 10.9% of aggregate costs for all hospital stays in 2022 across all payer groups — more than three times higher than the next most expensive condition: liveborn infants which accounted for 3.6% of aggregate costs.
      • “Among the most expensive conditions, liveborn infants were the most common reason for hospitalization at 10.6% of all hospital stays, followed by septicemia at 7.4%, heart failure at 3.3% and COVID-19 at 2.5%.
      • “Circulatory system conditions were the most frequent of the top 20 diagnoses for Medicare, private insurance or self-pay/no charge.
      • “Pregnancy and childbirth conditions were the most frequent among the top 20 conditions for Medicaid.”
  • and
    • “More than 150 independent rural hospitals across eight states have banded together into clinically integrated networks over the past three years, betting that shared scale, data and negotiating leverage can keep them out of the arms of consolidating systems and payers.
    • “The newest addition is the Show-Me High Value Network, a Missouri coalition of 23 independent hospitals that collectively serve more than 1.8 million residents across urban, rural and underserved communities. It joins a fast-growing map of rural high-value networks that includes: 
    • “Cibolo Health, a Texas-based consultancy that specializes in building rural hospital collaboratives, manages seven of the networks, including those in North Dakota, Minnesota, Ohio, Montana, Nebraska, Wisconsin and Kansas.”
  • and
    • “St. Louis-based Mercy recorded an operating income of $500.8 million (4.5% margin) for fiscal year 2026, up from $21.4 million (0.2% margin) in fiscal 2025, according to its Sept. 11 financial report.”
  • and
    • “Hershey, Pa.-based Penn State Health reported a $131.2 million operating gain on $5 billion in revenue for the fiscal year ended June 30, a significant improvement from the prior year, according to its audited financial statements.”
  • Beckers Payer Issues relates,
    • “Ujjwal Ratan has joined UnitedHealth Group’s consulting and analytics division, Optum Insight, as chief AI officer.
    • “In a Sept. 10 LinkedIn post, Mr. Ratan said his role is to enable Optum Insight to operate as a connected agentic network in healthcare.”
  • and
    • “Taft Parsons III, MD, is leaving his role as CVS Health’s chief psychiatric officer.
    • “Executives decide to try something different, and organizational structures and jobs change,” he said Sept. 11 on LinkedIn. “I’ve benefited from those changes more often than not, and I understand this is simply my turn to find another path toward improving healthcare.”
  • Beckers ASC Review tells us,
    • “National Healthcare Properties completed the sale of 30 primarily multi-tenant outpatient medical facilities for $198 million.
    • “The transaction represents the first tranche of its previously announced sale of 86 outpatient medical facilities for approximately $528 million, according to a Sept. 10 news release from the company. The remaining 56 facilities are expected to close in the fourth quarter of 2026.”
  • The Wall Street Journal points out,
    • “France’s Ipsen IPN is considering building a production site in the U.S., joining other European drugmakers looking across the pond when planning new investments.
    • “Discussions are ongoing,” Ipsen Chief Executive David Loew said in an interview. “No decision has been reached yet on exactly when, but this is certainly something that we are taking into consideration.”
    • “Loew said the next big plant the company builds will manufacture either its Dysport drug—a rival to AbbVie’s ABBV Botox—or a next-generation medicine called corabotase that is still under development.
    • “Many of the world’s top pharmaceutical companies pledged to make multibillion-dollar investments to bring manufacturing and other operations to the U.S. over the coming years, in a bid to mitigate tariff threats by the Trump administration. In addition to big companies like AstraZeneca and Roche, smaller drugmakers like Belgium’s UCB and Australia’s CSL also plan to invest in new U.S. facilities.”
  • Fierce Pharma lets us know,
    • “Both Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo saw their highest total prescriptions so far over the past week as the companies’ oral obesity battle continues to play out.  
    • “According to IQVIA data cited by Citi, the Wegovy pill reached an approximate 183K total scripts for the most recent reporting period, versus 181K the week prior. Foundayo, for its part, climbed nearly 8% to reach 47.5K scripts. Citi analysts emphasized that IQVIA may still be missing some Foundayo prescriptions made through telehealth channels. 
    • “Meanwhile, using the last four weeks as a guide, total GLP-1 prescriptions have increased by 5.4%, compared to a 6.8% decline the prior year, the Citi team said. Citi analysts attributed the 12-percentage-point swing to the expansion of oral GLP-1 therapies, which is likely broadening access to the class and drawing in new patients.  
    • “Across the broader landscape, Lilly’s tirzepatide currently holds a nearly 57% share of the total GLP-1 market, compared to around 49.5% last year, while Novo’s semaglutide has stayed relatively flat at a 37% share, the analysts added.”  

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • Modern Healthcare reports.
    • “Congress extended most annually funded healthcare programs through December, setting a likely end-of-year deadline for action.
    • “Lawmakers will have to decide which stalled health initiatives, from prior-authorization rules to transparency measures, would advance alongside must-pass extensions.
    • “Anti-fraud proposals could provide budgetary offsets to fund more expensive measures like a new Medicare physician payment system.”
  • Beckers Hospital Review relates,
    • “The Trump administration says it will mail $500 checks to nearly one million Americans in 30 states to refund what it called “overcharges” from ACA exchange fees collected under the Biden administration.
    • “On Sept. 10, the White House said insurers that sell plans on the federal exchange pay user fees to fund the platform’s operations, and that those fees generated a surplus that was never returned to consumers. The refunds, which are set to go out starting in October, will be provided to enrollees who did not receive premium tax credit assistance and paid the full cost of their premiums.” 
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced awards to 132 hospitals totaling nearly $25 million through the Rural Hospital Provider Assistance Program to help eligible small rural hospitals maintain their medical workforce, sustain essential healthcare services, and strengthen access to care for the communities they serve across 13 states.” * * *
    • “Awarded hospitals may use this funding to retain physicians, nurses, and other healthcare providers, allowing hospitals to preserve essential services, including emergency, inpatient, and other critical healthcare services. This support helps ensure rural communities can continue to access affordable care when and where they need it.
    • “A complete list of award recipients and more information about the program is available at Rural Hospital Provider Support Program FY 2026 Grant Awards.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that an $11.7 million investment is being delivered to support rural nursing care facilities and strengthen the healthcare workforce across rural communities in Vermont through the federal Rural Health Transformation Program (RHTP). Of this, Vermont is committing $9 million of those funds to provide tuition benefits to healthcare professionals in underserved or hard-to-fill positions who commit to serving rural communities within the state for at least five years after graduation. The remaining $2.7 million provides funding for three rural nursing homes to increase their capacity to serve residents with complex medical issues and four community partners to increase training of Licensed Nursing Assistants (LNA) to serve in rural healthcare and long-term care settings across the state.”
  • Cardiovascular Business relates,
    • “On Thursday, Sept. 10, CMS officially finalized a new national coverage determination (NCD) for TAVR. Arguably the biggest change is that TAVR will now be covered in Medicare beneficiaries who present with asymptomatic severe aortic stenosis (AS). The treatment of asymptomatic patients has been a hot topic in recent years. Some specialists see it as a way to treat patients early and avoid long-term damage. Others disagree, preferring to save TAVR for patients who present with symptoms. 
    • “Another key update is that Medicare beneficiaries with symptomatic severe AS is now covered without any sort of coverage with evidence development (CED) requirements. The TAVR NCD has always required facilities performing TAVR to follow certain CED rules that require patient data to be collected through clinical trials or registries. This is no longer the case when it comes to performing TAVR on symptomatic patients. 
    • “Five leading U.S. medical societies—the American Association for Thoracic Surgery, American College of Cardiology, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions and Society of Thoracic Surgeons—did work together to argue that CED requirements should still be in place, but CMS still moved forward with that particular proposal. 
    • “It is worth noting, however, that CED requirements are still in place when it comes to performing TAVR on asymptomatic patients.”
  • The American Hospital Association News tells us,
    • “The National Institutes of Health has launched its Connecting the Community for Maternal Health Challenge: Research Capacity Building in Maternity Care Deserts 2.0. The competition will award more than $3 million to encourage and reward biomedical research in maternal health with an emphasis on maternal morbidity and mortality and maternal health deserts. The challenge consists of four phases: recruitment, training, proposal and research. The recruitment phase closes Sept. 23 and is required to be eligible for later phases. If selected, participants in each phase will be considered for awards ranging from $10,000 to $300,000.”
  • and
    • “The Federal Trade Commission announced Sept. 9 that it rescinded its 2021 policy statement that extended applicability of its health breach notification rule to health apps and connected devices that collect consumer health information. The commission said the 2021 statement was superseded by its 2024 update to the health breach notification rule. The FTC said the recission is part of the administration’s deregulation efforts and follows the commission’s policy of avoiding unnecessary use of subregulatory guidance.”
  • Fierce Healthcare relates,
    • “Federal healthcare agencies are accelerating efforts to expand artificial intelligence’s role in healthcare, with clinical AI emerging as a top strategic priority for the Centers for Medicare & Medicaid Services.
    • “At a healthcare AI event hosted by the Consumer Technology Association (CTA) in Washington, D.C., on Wednesday, Stephanie Carlton, deputy administrator at CMS, outlined the agency’s evolving AI strategy as it aims to establish clearer pathways for AI market access and regulation while also exploring reimbursement frameworks for AI-enabled technologies.
    • “Carlton also serves as chief clinical AI officer at CMS, a newly created position that signals the Trump administration’s push to advance AI in clinical care.
    • “A centerpiece of CMS’ AI strategy is the ACCESS model—Advancing Chronic Care with Effective, Scalable Solutions. Carlton hinted that the agency would soon expand that model. Announced in December and launched in July, ACCESS is a new 10-year program for value-based chronic condition management that leans heavily on technology and AI to scale to large populations of patients.”
  • Healthcare Dive tells us,
    • “The Department of Veterans Affairs has selected Amwell to facilitate telehealth delivery across the agency.  
    • “Amwell’s platform, which mainly offers virtual health visits, will help veterans connect with VA providers or other specialists in clinic. It will also support other telehealth services, such as virtual care delivery and care coordination within VA hospitals. 
    • “The VA signed a letter of intent to implement Amwell’s platform. A binding contract will depend on Amwell satisfying federal requirements, including a review by the VA’s chief information officer.”
  • Per an Institute for Clincical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will develop a special report for the Centers for Medicare & Medicaid Services (CMS) on darolutamide (Nubeqa®, Bayer) for treatment of prostate cancer. This report will be submitted to CMS as part of the 2027 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2029. 
    • “While the final list of drugs subject to negotiation will not be released until February 2027, ICER is developing this report with the expectation that darolutamide will be subject to negotiation next year. The report will reflect legislative specifications in the Inflation Reduction Act and the most recent CMS guidance regarding price negotiations.
    • “ICER’s expertise in comparative clinical effectiveness and value will continue to help inform the important conversations around Medicare drug price negotiation,” said ICER’s President and CEO Sarah K. Emond, MPP. “While we know CMS may consider many different factors and inputs during negotiations, we believe ICER’s approach to applying the guidance in a consistent framework offers important information to all stakeholders engaged in this process.”
    • “The research protocol is now available.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“

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

  • Federal News Network reports,
    • “It may not come as a surprise that Americans’ trust in government has declined over the last several decades. When the first systematic measurement was taken by the National Election Study in 1958, about 75 percent of Americans said they trusted their government.
    • “Today that number has basically inverted, sitting at a discouraging 27 percent, according to the annual survey by the Partnership for Public Service.
    • “The unexpected news may not be Americans’ low confidence in government as much as how they report feeling about the federal employees who work for it. The same survey found that 65 percent of Americans view federal workers as competent, even while giving low marks to government as a single entity. Even more favorable, public perception of the federal workforce is the highest it’s been since the Partnership first asked the question in 2021.”
  • and
    • interviews a financial expert about the F Fund available in the Thrift Savings Plan.
      • “The TSP’s F Fund has trailed the G Fund over the last several years. Before deciding what that means for your own investments, it helps to understand what’s happening in the bond market.”

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Salmonella Bovismorbificans infections linked to recalled broccoli sprouts grown by Evergreen Fresh Sprouts, LLC of Moyie Springs, ID. This outbreak is currently being investigated separately from the shiga toxin-producing E. coli and Salmonella outbreak linked to alfalfa sprouts also being investigated by FDA, CDC, and state partners.
    • “Based on epidemiological information collected by CDC and state partners, a total of 22 people infected with the outbreak strain of Salmonella have been reported from four states. Illnesses started on dates ranging from July 7, 2026, to August 26, 2026. Of the 19 people interviewed, all 19 (100%) reported eating sprouts and 17 (89%) reported specifically eating broccoli sprouts. There have been two hospitalizations and no deaths.
    • “FDA’s and state partners’ traceback investigations have identified Evergreen Fresh Sprouts, LLC as the common grower of broccoli sprouts that were eaten by patients before becoming ill. On September 4, 2026, Evergreen Fresh Sprouts, LLC initiated a recall of broccoli sprouts based on a positive Salmonella result from a broccoli sprouts sample collected and analyzed by Montana state officials. According to whole genome sequencing analysis conducted by state partners and reviewed by FDA, the positive sample is the same strain of Salmonella that is causing illnesses in this outbreak. Consumers, restaurants, and retailers should not eat, sell, or serve recalled broccoli sprouts grown by Evergreen Fresh Sprouts, LLC with expiration dates of 9/7, 9/9, 9/11, 9/14, and 9/16.”
  • The Washington Post reports,
    • “Federal officials are poised to declare the end of the nation’s largest known cyclosporiasis outbreak after thousands of people became sick after eating shredded iceberg lettuce, according to two people familiar with the matter.
    • “The update may come as soon as later Thursday, according to the people, who spoke on the condition of anonymity to discuss an ongoing investigation. However, the timing is not guaranteed. In mid-July, Taylor Farms voluntarily recalled products from the market as federal officials began linking its lettuce from central Mexico to a cyclosporiasis outbreak. Food and Drug Administration enforcement records show recalled products were packaged for nine food service and retail operations, such as Subway and Yum Brands, which owns Taco Bell, KFC and Pizza Hut.”
  • BioPharma Dive relates.
    • Biohaven shares fell by more than 10% Thursday after the company revealed that the Food and Drug Administration has placed a partial hold on an experimental epilepsy medicine it recently sold off rights to in a licensing deal.
    • In a regulatory filing, Biohaven disclosed that the FDA has requested additional data related to a “metabolite,” or drug-related substance, that was identified in rodent studies of its treatment opakalim. The agency instructed Biohaven to pause recruitment in an ongoing late-stage trial until it can provide more information. Dosing will continue for those already involved in that study, “RISE-2.”
    • Importantly, the hold doesn’t affect a separate late-stage trial, “RISE-3,” that’s fully enrolled. That study is still expected to produce results later this year in what is a “key event” for Biohaven, wrote William Blair analyst Myles Minter. Should opakalim succeed in testing and win approval, Biohaven will be eligible for milestone payments and sales royalties from licensing partner SK Pharmaceuticals.

No Surprises Act News

  • Modern Healthcare reports,
    • “A group of nearly 70 employers, unions, patient advocates and other organizations is calling on Congress to rework the No Surprises Act of 2020. 
    • “The letter, led by left-leaning advocacy group Families USA and cosigned by 67 organizations, asked congressional leaders to address concerns about the law’s Independent Dispute Resolution process.
    • “Under the No Surprises Act, IDR arbitrators determine appropriate out-of-network reimbursement rates, with claims predominantly filed by providers or their aligned companies.” * * *
    • “Letter signers are calling on Congress to replace what they call the “baseball-style” arbitration process with a benchmark payment methodology that promotes market-based prices and discourages excessive reimbursement. 
    • “In an accompanying report, Families USA is also advocating for subjecting ground ambulance services to the law’s requirements; strengthening the federal process for certifying mediators; and requiring arbitrators to disclose their ownership structures, payment agreements and dispute outcomes information.” 

From the fraud, waste, and abuse front,

  • Per a Justice Department news release,
    • “Dompé U.S. Inc. (Dompé), based in California, has agreed to pay $32 million to resolve allegations that, between 2018 and 2021, it paid Medicare beneficiary co-pays through two patient assistance foundations to induce the purchase of its drug, Oxervate, in violation of the Anti-Kickback Statute and the False Claims Act.”
    • The claims resolved by the settlement are allegations only and there has been no determination of liability.

From the public health and medical / Rx research front

  • MedCity News reports,
    • “Heart disease is the leading cause of death among women in the United States, yet it remains chronically underrecognized, underdiagnosed and undertreated in this population. According to research from the American Heart Association (AHA), by the year 2050, the rate of total cardiovascular disease (CVD) in women will rise to 14.4%, a 3.7% increase from 2020 data.
    • “Data for reproductive age women (ages 20 to 44) shows a similarly troubling increase, from 1 in 4 in 2020 to nearly 1 in 3 in 2050 having clinical CVD. Diabetes in this same young age group is also projected to more than double, from 6% to nearly 16%.
    • “A critical opportunity exists at the intersection of prevention and rapid diagnostics in women’s health. Early intervention based on accurate diagnosis of both metabolic risk factors and acute cardiac events could help make the difference between life and death for women.”
  • Cardiovascular Business adds,
    • “Too much light exposure at night, both when asleep and awake, may be bad for the heart. That was the eye-opening takeaway from a new study published in European Heart Journal.
    • “Previous observational studies have linked nighttime light exposure with a higher risk of cardiovascular disease, but little is known about the related cardiac structure and functional changes,” senior author Lu Qi, MD, PhD, a researcher with Tulane University, said in a statement. “We carried out this research to find out what happens to the heart over time when people are exposed to too much light at nighttime.”
    • “Qi et al. tracked data from more than 11,000 UK Biobank participants. They wore a light sensor on their wrists for seven days. Three years later, they all underwent a cardiac MRI scan.
    • “Overall, study participants exposed to the most light—three lux or more—were associated with thickening of the wall of the left ventricle not seen in participants exposed to lower amounts of light. MRI results also showed that participants exposed to high amounts of light were experiencing issues with their heart muscle’s ability to flex during heartbeats, an early sign of heart damage.  
  • The New York Times relates,
    • “In the last few years, there’s been a cultural push for women in midlife to build strong bones.
    • “Menopause influencers and medical organizations alike have focused on the message that women’s risk for fractures increases dramatically after menopause, and that they should think about their bone density much earlier than their mothers might have.
    • “The American Medical Association recommends that women get their first DEXA scan — a low-dose X-ray that is the gold standard test for determining bone density — at 65 or older, unless they have a risk factor for osteoporosis.
    • “But a growing number of doctors and bone health experts now recommend earlier scans. They argue that if women wait until 65, they may miss a critical window to prevent osteoporosis.” The article delves into the details of this issue.
  • MedPage Today lets us know,
    • “People who consumed their hot beverages at a “very hot” temperature had a threefold higher risk for squamous cell carcinoma of the esophagus compared with those who drank them at a “warm” temperature, an analysis of two large U.K. cohorts suggested.”
  • and
    • “Borderline anemia — hemoglobin levels 0 to 1 g/dL above the WHO threshold — was associated with a higher risk of mortality, a prospective cohort study suggested.
    • “When stratifying results by age and sex, borderline anemia was associated with higher risks for all-cause, cardiovascular, and cancer mortality in men of all ages and in women 60 and older.
    • “These findings suggest that the relationship between hemoglobin concentration and long-term health cannot be captured by a single diagnostic cutoff, researchers said.”
  • The Washington Post tells us,
    • “People tend to think about supplements the way they think about food: Things that are inherently good or bad for you. Green beans are good. Potato chips are bad. Vitamin D and fish oil belong, presumably, on the green-bean side of the ledger.
    • “But the aging brain may change the calculation, putting some of America’s most popular supplements under new scrutiny.
    • “Recent research is raising a largely overlooked question: Can something that benefits (or is at least neutral to) a young, healthy brain become less helpful — or even harmful — as the brain ages?”
    • “In January, researchers reported an association between vitamin D supplement use and faster cognitive decline among older adults who already had normal vitamin D blood levels. In April, another study found that adults 55 and older taking omega-3 supplements showed greater cognitive deterioration over time than nonusers. Then, in June, researchers reported that people taking glucosamine, used for joint pain, appeared to have a much higher likelihood of progressing from mild cognitive impairment to dementia over five years than their peers who were not taking it.
    • “I was stunned,” said Ramon Sun, a professor of biochemistry and molecular biology at the University of Florida and the lead author of the glucosamine paper.” * * *
    • “The studies are mostly observational, meaning they don’t prove causation, and those links with mental deterioration may be because of the supplements or something else entirely.
    • “But together they point toward a possibility that researchers are beginning to take seriously: Aging changes how the brain handles fats, calcium and glucose, and how it responds to inflammation, which could alter how nutrients and drugs reach brain tissue in the first place.”
  • Beckers Health IT informs us,
    • “The American Heart Association’s PREVENT cardiovascular risk equations is now integrated into Epic’s EHR platform.
    • “The integration brings the cardiovascular risk assessment tool into clinicians’ existing workflows, where it can be used to estimate patients’ risk for heart attack, stroke and heart failure and inform prevention and treatment discussions.
    • “The PREVENT equations incorporate measures of cardiovascular, kidney and metabolic health and provide estimates of cardiovascular disease risk over 10- and 30-year periods. The tool is intended for adults ages 30 to 79 without a history of cardiovascular disease, according to a Sept. 10 news release.
    • “The equations were developed using health information from more than 6.5 million adults from a range of racial, ethnic, geographic and socioeconomic backgrounds, according to the association.”
    • “Recent American Heart Association and American College of Cardiology guidelines for managing high blood pressure, abnormal cholesterol and cardiovascular-kidney-metabolic syndrome recommend use of the PREVENT equations for cardiovascular risk assessment and treatment decisions.
    • “Embedding the equations within Epic is intended to make the risk estimates available at the point of care without requiring clinicians to use a separate tool, according to the association.”
  • Beckers Hospital Review points out,
    • “Among 31 cancer centers, 100% said they were experiencing a shortage of at least one anti-cancer drug, according to data published Sept. 10 by the National Comprehensive Cancer Network.
    • “The data summarizes August survey responses from pharmacy directors and other clinical and administrative leaders at 31 NCCN members, a Sept. 10 news release said.”

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

  • Healthcare Dive reports,
    • “Medicare Advantage insurers could see their star ratings fall next year — and lose out on the lucrative bonuses the ratings represent — after regulators boosted many of the thresholds for achieving the quality scores.
    • “Earlier this week, the CMS released draft cutpoints, the thresholds the agency uses to convert MA plans’ quality and performance scores into a 1 to 5 star rating, as part of the preview process before regulators announce official results in early October.
    • “About 50% of cutpoints got harder, 33% were unchanged and 17% actually got easier, according to analysis by the Newton Smith Group, an MA consultancy.”
  • Health Exec relates,
    • “For certain aspects of healthcare, Arizona is the freest state in the nation. The least free? New Jersey.
    • “The findings have nothing to do with no-cost services and everything to do with the legal, regulatory and policy environments governing healthcare across the United States. 
    • “They’re from the Center for Modern Health, a libertarian think tank focused on advancing free-market ideas in health policy.
    • “In the Center’s own words, the 2026 Health Freedom Index reflects state-level data on the degree of choice and freedom available to patients, healthcare professionals, insurers and entrepreneurs. 
    • “For each state, the project’s researchers measured performance across 54 variables and five kinds of “freedom”—professional, institutional, patient, payment and delivery—and used the sums to index the states from best to worst. 
    • “In addition, the project “aims to promote transparency and informed discussion about the role of freedom, voluntary exchange and institutional design in American healthcare.”
  • Beckers Hospital Review points out the top rehabilitation hospital in each State based on U.S. News & World Report compilation of a list of the top rehabilitation hospitals in every state. 
  • The Wall Street Journal informs us,
    • “An Association for Accessible Medicines report says 90% of biologic drugs losing patent protection by 2034 have no biosimilars in development.
    • “The lack of low-cost alternatives could cost Americans nearly $200 billion in healthcare savings over the next decade.
    • “The dispensing rate of available biosimilars over brand-name drugs fell to 23% in 2025, down from about 40% in 2024.”
  • STAT News notes,
    • “When Kura Oncology decided to take aim at a protein involved in cell division and signaling, researchers reported a bonus finding: Targeting the protein, menin, didn’t just control the growth of leukemia cells, it also helped control blood sugar levels in animal studies. The biotech on Wednesday announced that it is turning that insight into a new company.
    • “The new firm, Caspian Therapeutics, is launching with $50 million in financing to develop menin inhibitors for diabetes and other cardiometabolic diseases. The initial funding, led by BVF Partners and joined by Eli Lilly and members of Kura’s leadership team, among others, is meant to advance Caspian’s lead small molecule drug through an early-phase clinical trial in diabetes and support the development of a second candidate.”
  • Per Beckers Physician Leadership,
    • “Physician assistants averaged a salary of $155,000 in 2026, continuing a run of steady raises since 2022, according to a report from Medscape.
    • “The topline number hides a more complicated picture: pay growth varies widely by specialty setting, state and gender, and base salary itself grew more slowly than the bonus and incentive pay layered on top of it.”
  • Per Fierce Healthcare,
    • “Electronic prescribing platform Interra Health announced Tuesday that it now supports the U.S. Centers for Medicare and Medicaid Services’ (CMS) GLP-1 Bridge program for Medicare Part D beneficiaries.
    • “Eligible Part D enrollees can access GLP-1 medications at $50 per month through the program, which launched July 1. For Interra patients, the platform alerts providers when patients may be eligible to enroll in the program. Moreover, it instructs providers to submit proper codes and complete required prior authorizations.
    • “Interra Health Chief Business Development Officer J.B. Powell told Fierce Healthcare the program has delivered “more than 170,000 point-of-prescribing alerts to more than 30,000 unique prescribers” since its launch, adding that its requirements could “be confusing” for providers and patients to understand eligibility.”
  • and
    • “Plans to build a new, $2 billion-plus patient care tower and other accompanying upgrades at the University of Iowa Health Care’s main campus are off the table in favor of smaller-scale upgrades to existing facilities, the academic system said Wednesday. 
    • “Iowa Health Care had previously described the new patient tower as “critical to our ability to meet the healthcare needs of Iowans for years to come.” Primary construction wasn’t scheduled to begin in earnest until 2028 and targeted a 2032 completion.
    • “The organization is still facing a capacity crunch, noting in Wednesday’s announcement that it turns away 3,000 to 5,000 patient transfers a year “due to space constraints” even as it recorded over 41,000 inpatient admissions, almost 1.7 million clinical visits and over 43,000 major surgeries last fiscal year. 
    • “However, “significant financial challenges” facing the healthcare industry at large have limited Iowa Health Care’s ability to “responsibly” deploy capital toward the project. The organization stressed that its finances are stable, but now plans to submit a revised $380 million capital plan to its board later this month.”

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Department of Health and Human Services announced Sept. 8 through the Substance Abuse and Mental Health Services Administration that it will award $383.4 million in grants to support behavioral health treatment, prevention and crisis response efforts. HHS said $252 million will support the 988 Suicide and Crisis Lifeline, suicide prevention and mobile crisis services. Of the remaining grants, $81.4 million will be used toward substance use treatment and prevention initiatives, and $50 million will be used to support mental health services. The Sept. 8 announcement coincided with 988 Day, which raises awareness about the 988 lifeline and the importance of mental health and suicide prevention.” 
  • Bloomber Law reports,
    • “The Trump administration is pursuing additional drug pricing deals with pharmaceutical companies, Centers for Medicare and Medicaid Services Administrator Mehmet Oz told Bloomberg Television.
    • “Officials have announced more than two dozen voluntary agreements with pharmaceutical companies so far, and Oz said “there are more deals in the works.” He spoke ahead of his scheduled keynote address at the Republican midterm convention in Dallas Wednesday night.
    • “Each of the agreements is bespoke, but companies generally have agreed to lower the prices they charge public programs for medicines and to launch new drugs at prices similar to those paid by other developed nations in exchange for relief from tariffs. Some companies also are offering the discounted prices directly to consumers on a Trump-branded website, though critics argue the savings are minimal for patients with insurance.”
  • Axios adds,
    • “There are troubling new signs that the overhaul of Medicare drug coverage in the Inflation Reduction Act is dramatically driving up program spending. 
    • “Why it matters: The upward trajectory could threaten some seniors’ coverage for outpatient prescription drugs — and it could force painful tradeoffs over the next decade as Medicare consumes a growing share of the nation’s debt. 
    • “Follow the money: The IRA limited what seniors have to pay for outpatient drugs and shifted the remaining cost to taxpayers, insurers who provide stand-alone Medicare drug plans and drug manufacturers.
    • That was good news for enrollees who take expensive drugs for conditions like cancer, multiple sclerosis or rheumatoid arthritis and faced potentially crushing out-of-pocket costs.
    • But federal data shows demand for drugs is surging as they become more affordable, exceeding congressional scorekeepers’ spending estimates and setting off more alarms.
    • “Driving the news: Last week, congressional Medicare advisers reported that more than 1 in 5 enrollees hit Medicare Part D’s $2,000 patient cost cap in 2025 — shifting new costs to the government.”
  • Beckers Behavioral Health breaks down the Labor Department’s September 8 enforcement guidance concerning the mental health parity act into seven things to know:
    • “Certain behavioral health treatment exclusions could draw scrutiny.
    • “Prior authorization and medical necessity processes are a key enforcement area.
    • “The agency is looking closely at behavioral health networks.
    • “Compliance depends on how policies operate in practice.
    • “Telehealth, cost-sharing and visit limits can also raise compliance concerns.
    • “Plans are expected to use monitoring mechanisms to identify disparities.
    • “Corrective actions can require changes to coverage and plan operations.”
  • STAT News relates,
    • “ARPA-H, the government agency that funds cutting-edge health research, plans to commit $62.7 million to develop artificial intelligence bots that direct treatment of heart failure. Among the goals of the program, called ADVOCATE, is to produce partially autonomous AI devices authorized by the Food and Drug Administration to help treat patients, including assessing symptom severity, prescribing drugs, and ordering lab tests. 
    • “ARPA-H on Wednesday announced the first batch of awards to health tech companies Atman Health, UpDoc, Tempus AI, and teams from Stanford University, Duke University, and the Kaiser Permanente health system. ARPA-H may still fund additional teams. The amount committed for the first year is $33.7 million, and the remainder may be renegotiated up or down.” 

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

  • My Federal Retirement tells us about “What FEHB Enrollees Should Know if They Get a Letter from Medicare This Month.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “In an accelerated decision, the FDA expanded Bayer’s Hyrnuo indication, granting first-line approval for a rare tumor type in patients with non-small cell lung cancer. 
    • “Before the expansion, Hyrnuo was available only after other NSCLC treatments failed. But the FDA’s latest go-ahead makes the tyrosine kinase inhibitor (TKI) an initial therapy option for any patient with locally advanced or metastatic non-squamous NSCLC whose tumors test positive for HER2 tyrosine kinase domain activating mutations.   
    • “The expanded indication was won using data from Bayer’s ongoing phase 1/2 Soho-01 trial, in which Hyrnuo demonstrated a 75% objective response rate in previously untreated patients. Six percent of patients showed a complete response, and 70% showed a partial response to the twice-daily oral medication, Bayer said Wednesday. Responses lasted more than six months for 73% of patients.”
  • and
    • “With a phase 3 win now fleshed out and an FDA filing recently submitted, BioMarin is advancing expansion plans for Voxzogo, looking to extend the dwarfism drug’s reach as it faces new pressure in its inaugural achondroplasia indication. 
    • “On Wednesday, BioMarin unveiled detailed results from the phase 3 CANOPY-HCH-3 trial assessing Voxzogo in children with hypochondroplasia (HCH), a milder form of achondroplasia, where the company announced a topline win back in May. 
    • “Aside from the average 2.33 cm/year improvement in annualized growth velocity (AGV) on Voxzogo that BioMarin reported out earlier this year, the company dug deeper into the magnitude of benefit its medicine could offer to children with HCH across measures like standing height and arm span after a year of treatment.
    • “BioMarin shared the data Wednesday at the European Society for Paediatric Endocrinology annual meeting and simultaneously published the results in the New England Journal of Medicine.” 
  • Cardiovascular Business points out,
    • “Luma Vision, an Irish medtech company focused on electrophysiology and interventional cardiology technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its updated Verafeye imaging and visualization platform. The company previously received FDA clearance for the artificial intelligence-powered offering in 2025; this update covers the platform’s expanded capabilities ahead of a planned commercial launch in 2027.
    • “The Verafeye platform provides ultrasound imaging courtesy of a 360° catheter that creates real-time 2D and 3D maps of the patient’s heart. It also offers advanced visualization and navigation capabilities, helping users track imaging and ablation catheters during treatment. In addition, users are able mark locations as they go to confirm they achieve the necessary alignment.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “First responders and other New Yorkers around the World Trade Center that day have reported conditions including respiratory issues, mental health impacts and dementia. Toxins were present in the air soon after the attacks even though people were assured it was safe, according to a trove of records released this week by New York City officials.
    • “Twenty-five years later, attention is increasingly falling on cancer. 
    • “The number of 9/11 survivors who are receiving aid for cancer has roughly tripled over the last five years, according to a Washington Post analysis of reports from the World Trade Center Health Program, which funds health care for first responders and 9/11 survivors in New York. In June 2021, 8,870 survivors received aid for cancer treatment, jumping to 27,300 survivors in 2026 — numbers that sharply outpaced cancer claims among first responders.
    • “Of the roughly 54,000 survivors enrolled in the health program as of June, about half are receiving aid for cancer. Five years ago, that share was 35 percent.” * * *
    • “A recent New York University study of a smaller cohort of 9/11 survivors receiving medical aid as of 2024 reported a similar increase in cancer cases; it found that cases had increased around 2.5-fold between 2019-2024.
    • “This is something that we are worried about,” said Alan Arslan, an associate professor of population health at NYU and one of the authors of the study. “We’re seeing more and more patients.”
  • The Wall Street Journal relates,
    • “Dr. Henry Heimlich devised a new technique more than 50 years ago to stop people from choking. Simplicity, studies, shrewd promotion by its inventor—and a demonstration on The Tonight Show Starring Johnny Carson—made the Heimlich maneuver a go-to method.
    • “Now, it is fighting for the stage.
    • “Advocates, companies and some politicians argue that the Heimlich maneuver and back blows, another established method of rescuing people from choking, aren’t always enough. On social media and in state legislatures, they are plugging portable anti-choking devices, designed to suction stuck food or other objects from a person’s airway.
    • “Texas enacted a law last year requiring school districts to stock at least one such device on each campus with at least one employee trained to use it. New York City passed one, too. At least nine other states have weighed or are weighing bills to put devices into schools or other facilities.
    • “It’s a priority,” said New Jersey state Sen. Kristin Corrado, who co-sponsored one bill. “If we have the opportunity to save a life, we have to use all means available.” 
    • “The main U.S. maker—a company called LifeVac—has donated more than 10,000 devices to schools across the country.” * * *
    • “But medical guidelines and many researchers say there isn’t enough evidence to recommend anti-choking devices. State health departments, emergency responders and teachers unions have pushed back against proposals to require them in schools because medical guidelines haven’t endorsed them. New York City said it wouldn’t implement its law unless the devices are recommended in medical guidelines.”
  • Beckers Behavioral Health tells us,
    • “The synthetic opioid cychlorphine has been linked to at least 55 deaths nationally from 2025 to 2026, with prevalence highest in Ohio, Tennessee and Texas, MedPage Today reported Sept. 8.
    • “The Office of National Drug Control Policy said in an April drug threat notice that cychlorphine may be “up to 10 times more potent than fentanyl” and an overdose may require multiple doses of naloxone.
    • “In Tennessee, the Knox County Regional Forensic Center reported 41 overdose deaths between July 2025 and February 2026. The center tracked as many as 63 cychlorphine-associated deaths through June 30, and cychlorphine was found to be the cause in 58 of those cases.
    • “Cychlorphine has been found mainly in powders and tablets as well as counterfeit pills. Shravani Durbhakula, MD, MPH, of Vanderbilt University School of Medicine in Nashville, Tennessee, said snorting and inhaling are common, though oral exposure and injection are also possible.”
  • Cardiovascular Business informs us,
    • “A majority of transcatheter aortic valve replacement (TAVR) present with a history of heart failure (HF). According to new data published in the Journal of Cardiovascular Medicine, however, many of those patients are not being given the HF medications they need after undergoing TAVR.
    • “Cardiovascular morbidity and mortality remain high after TAVR,” wrote first author Elena Surkova, MD, MSc, PhD, a senior medical director at AstraZeneca and consultant cardiologist with Royal Brompton and Harefield Hospitals, and colleagues. “There is a lack of detailed data on the prevalence of HF in patients undergoing TAVR, medication prescription rates, including the main pillars of HF standard of care, and predictors of HF worsening following the procedure.”
  • The American Medical Association lets us know what doctors want patients to know about West Nile virus
    • “Most West Nile virus infections cause no symptoms, but some can lead to severe illness. Mosquito-bite prevention remains the best defense.”
  • MedPage Today adds,
    • “A gender gap historically seen in the suicide rates of 10- to 14-year-olds in the U.S. has tightened.
    • “In 2017, the suicide rate of boys was twice that of girls, but by 2024, it was only 4% higher.
    • “The author noted that the nearly equal suicide rates for 10- to 14-year-old boys and girls in the current study marked the “first time this has happened in the available records.”
  • Health Day notes,
    • “Autism spectrum disorder (ASD) diagnoses increased disproportionately among females after 2020, across age groups, while remaining stable or declining among males, according to a study published online July 22 in JAMA Network Open.
    • “Erick Messias, M.D., Ph.D., from St. Louis University, and colleagues evaluated age- and sex-specific incidence trends of ASD from 2016 to 2024 to quantify the temporal patterns before and after the COVID-19 pandemic. The analysis included electronic health record data from 171,134 individuals who had at least one clinical encounter annually at a large health care system.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of a preclinical study by researchers at the University of East Anglia suggest that an experimental anticancer drug could stop osteoporosis and help women prevent weight gain after the menopause. Their study in mice found that the small molecule drug CADD522 not only protected against osteoporosis but could also reduce body fat and reverse some of the metabolic changes linked to menopause. Currently in development for cancer therapy, CADD522 is a small molecule inhibitor of the transcription factor RUNX2, which is helps to drive the growth and spread of several cancers.
    • “Research lead Darrell Green, PhD, at UEA’s Norwich Medical School, said, “We have uncovered an entirely new way of tackling the disease. We found that a drug originally developed to stop cancer could help millions of women facing the twin challenge of fragile bones and midlife weight gain. We hope our work could lead to a new generation of osteoporosis treatments that tackle bone loss while also addressing some of the wider metabolic consequences of menopause.”
    • “Green is senior and co-corresponding author of the team’s report in npj Drug Discovery, titled “RUNX2 inhibitor CADD522 improves bone microarchitecture and lipid metabolism in post-menopausal bone loss.” In their paper the team concluded that their collective studies “… identify RUNX2 inhibition as a therapeutic strategy that simultaneously improves skeletal integrity and metabolic homeostasis, supporting further development of CADD522 for osteoporosis and other RUNX2-driven diseases.”

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

  • The International Foundation of Employee Benefit Plans reports,
    • “Medical stop-loss premiums in 2026 show an increase from 13.6% on a $100,000 deductible to 15.9% on a $750,000 deductible, as reported by the 2026 Aegis Risk Medical Stop-Loss Premium Survey, cosponsored by the International Society of Certified Employee Benefit Specialists. Notably, this increase is approximately 5% to 5.5% higher than increases seen for the previous 2025 renewals. This impact was not surprising, as many underwriters reported increased severity and frequency in stop loss-claims in late 2024 and a resulting erosion in claims-to-premium loss ratios thereafter and throughout 2025. The survey captured necessary correction to 2026 premiums. The measured increases, rising alongside the size of deductible, reflect leveraged medical trend, as the underlying growth in expense of a catastrophic medical claimant is fully borne by an unchanged deductible.
    • “Survey response uniquely captures final, negotiated premium and reflects any pricing improvement from renewal marketings and concessions across all deductibles. In comparison, several large direct underwriters reported an average 2026 increase in the low 20% range on their own book-of-business. However, those are weighted by in-force policies unable to locate lower cost alternatives. The comparatively lower increases observed in this survey reflect the 2026 renewal rate opportunity found in the market. Looking ahead, an ongoing return to underwriter discipline and need to restore insurer loss ratios to a more profitable position does not indicate any easing on the 2027 renewal cycle.”
  • Fierce Pharma relates,
    • “Shifts in drug pricing and market access policies around the world have caused an “earthquake” that will reverberate for years to come, a survey of industry leaders found.
    • “Healthcare consultancy Numerof & Associates generated the insights in a survey of 175 executives from 67 pharmaceutical companies. The qualitative survey revealed the belief that the current era of policy change is unlike anything that the industry has experienced before. After going through a period of fast change, the industry is braced for more upheaval in the coming years. 
    • “While there has always been change throughout the industry, the past 24 to 36 months have felt more exponentially transformative than anything I have seen over the last 30 years,” an executive said. “What we may experience over the next five years could exceed the cumulative level of change we saw over the previous several decades.”
    • “Another executive characterized the policy environment as an “earthquake” that is “not going to settle down soon,” while a third person predicted that the need for politicians to try to address the cost of healthcare will ensure ongoing change. 
    • “The executives were talking after a succession of policy changes in key markets. Medicare gained the authority to directly negotiate prices for some drugs, and the most-favored-nation (MFN) policy tied U.S. prices to overseas markets.” 
  • Healthcare Dive tells us,
    • “UnitedHealthcare is still drilling down on actions it can take to make its Medicare Advantage plans more profitable next year, even as the insurer is expected to exit more underperforming geographies. But the company could be poised for growth in the markets where it remains, according to new comments from a top executive.
    • “We think we’re going to be very competitive in terms of our pricing next year,” CFO Wayne DeVeydt said during Wells Fargo’s annual healthcare conference Wednesday morning. “We think our benefits will be competitive … We still have a few markets where we’re right-sizing some of the products, but I think we’ll be well-positioned for 2027.”
    • “DeVeydt’s comments come as market watchers try to get a sense of how 2027 open enrollment will pan out, following an especially turbulent sign-up period for 2026 after insurers culled their plans in a bid to resuscitate flagging margins.”
  • Modern Healthcare adds,
    • “UnitedHealth Group and CVS Health are looking into acquisitions, executives said at a Wells Fargo conference.
    • “UnitedHealth Group identified value-based care companies and companies that would fit into its Optum Insight division as targets.
    • “CVS Health will seek “bolt-on” acquisitions and resume share buybacks next year.”
  • Beckers Payer Issues informs us,
    • “Anthem is now covering three surgical meshes for breast reconstruction, according to a clinical guideline published Aug. 27.
    • “DuraSorb Monofilament Mesh, GalaFLEX and TIGR Matrix Surgical Mesh “are considered medically necessary when used for breast reconstruction surgery,” the guidance said.
    • “We regularly review our medical coverage policies to ensure they’re aligned with credible medical evidence and the latest treatment standards and expert recommendations,” an Elevance Health spokesperson told Becker’s.” * * *
    • “ABC affiliate WFTS-TV in Tampa, Fla., has been reporting on breast cancer insurance denials, including for mesh, in recent years. It reported how Cigna updated its policy to cover mesh for breast reconstruction in 2025.
    • “Despite calls for insurer coverage, mesh for breast reconstruction has not secured FDA approval.”
  • and
    • “UnitedHealth Group’s Optum has sold interest in some of Optum’s Florida WellMed clinics to private equity company TPG, Bloomberg originally reported Sept. 9. UnitedHealth Chief Financial Officer Wayne DeVeydt told Bloomberg that the healthcare company was looking for a partner “that could actually work with us locally,” and UnitedHealth “didn’t need the dollars.” 
    • “We entered a strategic partnership designed to strengthen operating performance through dedicated support for clinic operations, targeted investments in technology and tools, and enhanced operating capabilities,” an Optum spokesperson told Becker’s Sept. 9. “The transitioning clinics will remain part of Optum’s network and continue providing high-quality care to patients. We remain committed to serving Florida patients through our integrated, value-based care model.”
  • Beckers Behavioral Health lets us know,
    • “Santa Fe, N.M.-based Quel Health launched a telehealth platform focused on using GLP-1 receptor agonists in addiction care. 
    • “The platform is available in 41 states and the District of Columbia, with national coverage planned by year-end, according to a Sept. 8 news release from the company. Quel also named Wernersville, Pa.-based Caron Treatment Centers a founding strategic partner.” * * *
    • “The approach follows work at Caron’s Pennsylvania and Florida campuses, where Steven Klein, MD, PhD, co-founder and chief medical officer of Quel Health, and his team evaluate GLP-1 receptor agonists in patients whose primary diagnosis was substance use disorder rather than obesity or diabetes.” 
       
  • Per Fierce Healthcare,
    • “Employers Health and Judi Health are teaming up to launch StarkRx, a new cost-plus benefit offering designed to drive transparency for employers.
    • “The approach unites the expertise of Employers Health as a group purchasing organization for pharmacy benefits that’s backed by employers with the technology available through Judi. The goal, the partners said, is to ensure that self-funded employers have greater access to transparency data that they can use to identify and manage cost drivers.
    • “Employers are expected to see another year of significant healthcare cost increases in 2027, with pharmaceuticals serving as a major factor behind the trend. A recent analysis from Marsh (formerly Mercer) estimated that costs could increase by 8.2% next year.
    • “Advanced, high-cost therapies and GLP-1 medications were both cited as key cost drivers in that analysis.”
  • and
    • “H1 has acquired Defacto Health, a healthcare data company focused on provider network intelligence, in a move to expand its offerings for health plans and strengthen its healthcare data assets.
    • “H1 is an AI-powered platform that brings healthcare data, domain expertise and an artificial intelligence platform to life science companies. The company built an AI-powered platform that helps identify and engage the right doctors for critical workflows across pharma, health plan, health system and technology companies. 
    • “Defacto Health is an AI-driven provider intelligence platform that aggregates and analyzes health insurance payer networks, provider directories and medical demographics data. The company maintains data on payer networks, healthcare providers and the insurance plans providers accept, helping health plans assess directory accuracy, isolate error clusters and benchmark their networks.”
  • Beckers Hospital Review reports,
    • “The American Medical Association released its 2027 Current Procedural Terminology (CPT) code set Sept. 9, an update that adds 299 codes and continues to build out billing for clinical AI.
    • “The set takes effect Jan. 1 and carries 453 total editorial changes: 299 new codes, 74 revisions and 80 deletions, the AMA said.
    • “Ten of the new codes describe AI-related services, raising the total number of AI-related CPT codes to 43. The AMA also updated Appendix S, its taxonomy that sorts medical AI by how much of the work the machine does — assistive, augmentative or autonomous — and guides how new tools get coded.
    • “As new technologies and clinical approaches emerge, the nation’s health system needs a reliable way to describe the care physicians provide,” said AMA President Willie Underwood III, MD. Dr. Underwood said a physician-led coding system gives that work “unmatched scale, expertise and legitimacy.”
    • “The set’s key clinical change, released in August, is a maternity coding overhaul that retires the decades-old global maternity bundle in favor of separate reporting across antepartum, labor, delivery and postpartum care.”
  • MedTech Dive offers “5 takeaways from Oura’s IPO filing.”
    • The wearables firm’s sales are growing, and it is adding more paid members, but questions loom about whether the company will need to approach future features as a medical device.
  • and tells us,
    • “Labcorp said Tuesday it has acquired MLM Medical Labs to add global central laboratory and biomarker capabilities for clinical trials.
    • “MLM is a global central and specialty laboratory provider with operations in the U.S., Germany and South Africa. 
    • “The deal makes Labcorp the only central laboratory provider with a wholly owned lab network across four continents, the acquiring company said. Neither party disclosed the financial terms of the deal.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC

  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, September 15, 2026, at 10:00 AM ET to consider Gerard Klomp to be Deputy Secretary of Health and Human Services (HHS); James Gadwood to be Chief Counsel for the Internal Revenue Service (IRS) and an Assistant General Counsel in the Department of the Treasury; Ge Bai to be an Assistant Secretary of HHS; and Andrew A. De Mello to be a Judge of the United States Tax Court.” * * *
    • “Opening statements and a live video of the hearing will be available on www.finance.senate.gov.”
  • Beckers Hospital Review reports,
    • “HHS has selected four senior leaders for the FDA, including directors for the agency’s drug, biologics and tobacco centers and its first deputy commissioner focused on technology and artificial intelligence.
    • “Jared Seehafer was selected as the FDA’s first deputy commissioner for technology and artificial intelligence, according to a Sept. 8 HHS news release. He will serve as the agency’s senior leader for technology, software and AI and lead FDA-wide strategy and priorities in those areas.
    • “Michael Davis, MD, PhD, was selected as director of the Center for Drug Evaluation and Research after serving as acting director since May, when his predecessor was fired days after the agency’s commissioner stepped down. He will lead the center responsible for helping ensure safe, effective and high-quality drugs are available to the public.
    • “Karim Mikhail was selected as director of the Center for Biologics Evaluation and Research after serving as acting director, a post that has seen frequent turnover over the past year and a half. The center regulates biological products, including vaccines, blood and blood products and cellular and gene therapies.
    • “Bret Koplow, PhD, was selected as director of the Center for Tobacco Products after serving as acting director. He has served at the FDA since 2011.”
  • Behavioral Health Business informs us,
    • “The Trump administration today released guidelines on renewed enforcement efforts under the Mental Health Parity and Addiction Equity Act (MHPAEA), after halting enforcement of the law in 2025.  
    • “The latest guidelines are not the administration’s revised parity law, but rather a framework for enforcement action and identifying red flags during the interim. 
    • “A Sept. 8 bulletin from the Assistant Secretary for the Department of Labor’s Employee Benefits Security Administration (EBSA), Daniel Aronowitz, describes the agency’s intent to more substantially enforce the parity law’s nonquantitative treatment limitation (NQTL) requirements, which resulted from collective industry feedback.” * * *
    • “The renewed enforcement focus will fall into three buckets, identified as areas of enforcement need in a 2025 report from the agency to Congress: treatment limitations and exclusions; standards for medical necessity and review and standards for determining network adequacy, admissions and provider reimbursement methodologies.” 
  • Beckers Hospital Review tells us,
    • “ACA insurers requested a median rate increase of 15% for 2027, according to a Peterson-KFF Health System Tracker analysis. However, [as explained in the article,] some states are pushing back — while others are abiding by those requests — as they finalize increases.”

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

  • FedScoop reports,
    • “The Office of Personnel Management is looking to prevent data on the federal government’s public job board, USAJobs, from making its way onto misleading websites. 
    • “Last week, OPM updated terms of service for users of its USAJobs application programming interface (API) to include prohibitions on several actions related to the sale or redistribution of data from the website “to third parties as a standalone product or feed.” 
    • “Data provided to you through the API is for the explicit use of the requesting company or individual identified on the USAJOBS Program Office API Registration Form. No other use of the data provided is permitted without prior approval, in writing, from OPM USAJOBS,” said an emailed notice sent to API users, including FedScoop. 
    • ‘While the reason for that change wasn’t initially clear, an OPM spokesperson told FedScoop via email Friday that the policy change is aimed at preventing “unauthorized services that appear to be USAJOBS or allow users to apply for federal jobs outside USAJOBS.” 
  • Federal News Network interviews Tammy Flanagan about questions that federal and postal employees may have about their FEHB and PSHB coverage as they turn 65 years old.

From the judicial front,

  • Beckers Payer Issues reports,
    • “Humana lodged a federal complaint Sept. 3 against Bayer AG and its acquired company, Monsanto, the business behind the weedkiller Roundup, seeking recoveries to address payments for Medicare Advantage members’ non-Hodgkin lymphoma-related care.
    • “Roundup’s active ingredient, glyphosate, has previously been linked to cancer risks. The lawsuit, filed in the U.S. District Court for the District of New Jersey, follows Monsanto’s proposed $7.25 billion settlement in February to resolve Roundup claims alleging non-Hodgkin lymphoma injuries. The settlement would act as a long-term compensation program, addressing current and future claims. Monsanto announced other settlement agreements in 2020, as well.
    • “However, Humana argues the February proposal does not confirm reimbursement for Medicare Advantage organizations that have already paid for relevant care. While the settlement acknowledges government payers, it establishes an “other insurers” category, including contracted payers. The complaint said this settlement lacks a “functional” lien-resolution program.”

From the fraud, waste, and abuse front,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “As part of the White House Anti-Fraud Task Force’s ongoing efforts to crush fraud in the healthcare system and protect taxpayer dollars, the Centers for Medicare & Medicaid Services (CMS) has identified and is barring 11 medical supply companies with more than $3.4 billion in suspected fraudulent billing practices in 2025 and 2026 from receiving future Medicare Advantage (MA) Part C and Part D payments. These 11 durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers, (1) had submitted no claims prior to 2025; (2) used improper billing practices for their claims; (3) had billed for medical equipment to beneficiaries already deceased; and (4) supplied equipment to beneficiaries who never requested or received it. Four of the suppliers had already been revoked from Original Medicare and began billing Medicare Advantage plans instead.” 

From the public health and medical / Rx research front,

  • Beckers Hospital Review reports,
    • “Albuquerque, N.M.-based Presbyterian Hospital said it found Legionella pneumophila in limited areas of the water system, including two rooms, Fox affiliate KRQE reported Sept. 7.
    • “The hospital implemented testing for the bacteria after a patient who recently received care at the hospital tested positive for Legionnaires’ disease. However, officials with the New Mexico Department of Health told CBS affiliate KOAT there is no definitive evidence showing the patient contracted the bacteria from Presbyterian. No additional cases have been identified and there is no known exposure to other patients or staff.
    • “The hospital received the environmental testing results Sept. 3 and immediately implemented safety precautions in affected areas.”
  • MedPage Today relates,
    • “Nicotine was long thought to fuel the inverse relationship between smoking and Parkinson’s disease.
    • “In this study, nonsmokers with high carbon monoxide (CO) levels had less Parkinson’s risk, suggesting CO may underlie smoking’s neuroprotective effects.
    • “The study followed more than 500,000 people for 12 years, measuring exhaled CO at baseline.”
  • and
    • “In a study of perimenopausal and recently postmenopausal women with vasomotor symptoms, initiation of menopausal hormone therapy (MHT) was associated with a 22% reduction in cardiovascular events.
    • “Notably, benefits were observed in those who initiated hormone therapy within 10 years of menopause onset and in Black women.
    • “The authors cautioned that given the lack of consistent cardiovascular benefit and the overall risk-benefit balance, the findings shouldn’t be used to support the use of MHT for cardiovascular prevention.”
  • Healio adds,
    • “Menopause remains inconsistently documented in electronic health records, according to a new systematic review published in Menopause.
    • “We expected to find some variation in how menopause was documented, but the extent of the inconsistency was striking,” Robin R. Austin, PhD, DNP, DC, MSN, RN, NI-BC, FAMIA, FAAN, an associate professor at the University of Minnesota School of Nursing, told Healio. “Menopause status and symptoms were often identified indirectly or incompletely, making it difficult to understand where a woman is in the menopause transition.”
  • Reuters tells us,
    • “Prescriptions for GLP-1 weight-loss drugs among children under 12 in the U.S. have risen more than 300-fold since 2019 as doctors seek new, effective ​treatments for younger patients with obesity, according to a study published on ‌Friday.
    • “The study, which included more than 3.5 million children aged between eight and 11 years with obesity but not diabetes, found that prescriptions for GLP-1 weight-loss drugs rose from 0.03% in ​2019 to 9.3% as of June.” * * *
    • “Although the drugs are not approved ​for use in children under 12 years, clinical guidelines allow the ⁠medications to be used for obesity in children as young as eight years ​old in certain cases.
    • “94% of the children prescribed GLP-1s had severe obesity, and ​about 65% had at least one related condition, such as high cholesterol, high blood pressure, and sleep apnea.” * * *
    • “While the absolute numbers of ​children under 12 receiving GLP-1 treatment is still low, the study shows that GLP-1 use ‌is ⁠accelerating rapidly, said lead investigator and obesity medicine specialist Dr. Babak Orandi of NYU Langone Health.”
  • Fierce Pharma adds,
    • Novo Nordisk has reported a phase 3 weight-management win for Wegovy in children, with two out of five kids no longer classified as having obesity after receiving the GLP-1 drug for 68 weeks.
    • Wegovy, the brand name for semaglutide in indications including obesity, is FDA approved for reducing body weight in people aged 12 years and older. Yet Wegovy and other GLP-1 drugs are increasingly used off-label in younger children, with a recent study finding that prescriptions in kids aged 8 to 11 jumped from 0.03% in 2019 to 9.3% in 2026.
    • Novo’s Step Young phase 3 trial suggests the younger children may benefit from Wegovy. Participants received weekly Wegovy injections of either 1.7 mg or 2.4 mg, based on their weight at the start of the trial, or placebo. All participants were assigned a reduced-calorie diet and increased physical activity.
  • STAT News informs us,
    • “In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday. 
    • “Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that “tozo,” as the injectable drug is dubbed, could reap billions in annual sales if approved, both in COPD — which, as the third-leading cause of death globally, remains greatly underserved — and in other conditions including asthma.” 
  • BioPharma Dive adds,
    • “Roivant said Tuesday a would-be treatment for a particular kind of high blood pressure associated with lung inflammation met all of its main and secondary objectives in a Phase 2 trial. Roivant’s medication, “mosliciguat,” reduced by 56% a measure of how difficult it is for blood to flow through the lungs of people with pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Roivant claimed that result was the “highest ever reported” in a randomized pulmonary hypertension trial and has already begun a Phase 3 study. The “exceptional” results, along with plans to develop mosliciguat in other conditions, could yield a drug with more than $10 billion in yearly sales, wrote Leerink Partners analyst David Risinger. Roivant shares surged 20%.”
  • and
    • “A new kind of cancer cell therapy from Bristol Myers Squibb has come through in a mid-stage trial, the company announced Tuesday. Dubbed arlocabtagene autoleucel or arlo-cel, the therapy is a CAR-T treatment directed at GPRC5D, a cell surface protein that’s overexpressed on diseased cells in multiple myeloma. Bristol Myers didn’t provide specific details. But it said arlo-cel demonstrated a “statistically significant and clinically meaningful” response rate in people whose multiple myeloma had progressed following at least four treatment lines — among them drugs aimed at BCMA, a more established multiple myeloma target.”
  • Fierce Pharma notes,
    • “In further validation of the DLL3 target pioneered by Amgen’s Imdelltra, the T-cell engager has delivered an overall survival win in first-line small cell lung cancer (SCLC).
    • “Imdelltra, used together with AstraZeneca’s Imfinzi, led to a “statistically significant and clinically meaningful” improvement in overall survival (OS) compared with Imfinzi alone as a first-line maintenance treatment for extensive stage SCLC, Amgen announced Tuesday.
    • “The Imdelltra regimen also showed superior progression-free survival and objective response rate, with safety consistent with the drugs’ known profiles, the company added.”
  • Genetic Engineering and BioTechnology News lets us know,
    • “Although the highly contagious bacterium Clostridioides difficile (C. diff) causes severe disease in adults, it has been reported to not cause symptoms in infants. Based on that, the assumption has been that infant colonization was not a serious health issue. That said, the consequences of early-life colonization on host development remain unknown. Now, in a new study, researchers at Children’s Hospital of Philadelphia (CHOP) are challenging that long-held assumption, with new findings suggesting that the bacterium can reshape the developing infant gut and may have long-term consequences.
    • “This work was published in Science in the paper, “Early-life colonization with Clostridioides difficile remodels the developing gut.”
  • The New York Times points out,
    • “Last year, a clinical trial conducted by Insilico Medicine, a company that aims to accelerate drug discovery using artificial intelligence, indicated that one of its drug candidates could help treat patients suffering from a chronic lung disease.
    • “Now, the company says that data from the same clinical trial shows a more intriguing possibility: that the drug could also slow the aging process.
    • “The molecular structure of the drug, called rentosertib, was generated with the assistance of A.I. Results of the new study, published Monday in the journal Nature Biotechnology, show that the drug reduced the biological markers of age as measured by six “aging clocks,” a different kind of A.I. technology designed to predict a person’s morbidity and mortality.
    • ‘This elaborate clinical trial is a milestone in the widespread effort to improve health care using the same A.I. techniques that underpin popular chatbots like ChatGPT and image generators like Midjourney. Insilico is just one of many start-ups, tech giants and academic labs working to accelerate drug discovery and honeother medical tasks with help from these methods.”
  • and
    • “It is one of biology’s most ingenious rhythms: Every baby is born young. No matter how much wear and tear their parents’ DNA accumulated over their lifetimes, reproduction erases the molecular scars, handing a clean slate to the next generation.
    • “Now, a new frontier in biotechnology aims to harness this natural mechanism to do something once thought impossible: scrub away the biological detritus of our own past. By mimicking Mother Nature’s magic eraser, geneticists are working to open a new avenue for treating or preventing disease later in life — not by editing genes themselves, but by altering when, where and how genes are expressed.
    • “All of this is possible thanks to the epigenome, a network of chemical tags throughout the body that latch on to DNA and tell each cell type how to behave. If a person’s DNA is a string of notes in a musical score, the epigenome is the collection of the conductor’s pencil markings left on the page — accumulated through experience over time, indicating which notes to play louder or softer or to skip entirely.”

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

  • Beckers Payer Issues reports,
    • “Growth in healthcare spending, not insurer profit margins, drove the vast majority of commercial premium increases over more than a decade, according to a study published Sept. 4 in JAMA Health Forum.
    • “Researchers at Yale University and the University of Wisconsin-Madison analyzed CMS data from 2011 to 2024 covering the large group, small group and individual markets, which included information on premiums, health spending and insurer markups for each state and year. The data did not include self-insured employers, which cover roughly half the U.S. population.”
  • Fierce Healthcare relates,
    • “After a failed round of in vitro fertilization this year, Anne Hug’s fertility doctor said she had a single polyp in her uterus that should be removed to improve the chance of pregnancy. Hug, a professor of radiology, learned that the American College of Obstetricians and Gynecologists says the procedure can be done in a doctor’s office with local numbing.
    • “Her doctor referred her to a physician at the same hospital, which is part of a large Ohio health system. That doctor’s plan was to do the procedure in a hospital operating room, with anesthesia administered by an anesthesiologist.
    • “Hug balked at the $18,000 estimate.
    • “The estimate for the in-office procedure was around $3,000. The bill when she was forced at the last minute to switch to the surgery center was around $6,000. She now wonders, “How is it legal for these hospitals to force patients to have procedures done in a hospital when professional organizations recommend differently?”
    • “Hug’s experience is a classic example of the predicted outcome of “vertical integration” in the healthcare system, when one company owns or controls multiple parts of a supply chain and can therefore direct patients to more expensive treatment options.”
  • Beckers ASC Review tells us,
    • “Twenty-seven states [listed in the article] have opted out of the federal requirement that a physician supervise CRNAs administering anesthesia, according to the American Association of Nurse Anesthesiology’s most recent fact sheet, updated in July 2026.
    • “Vermont and Ohio became the 26th and 27th states to opt out, making the move in July 2026. The full list stretches back more than two decades, and for ASC leaders dealing with anesthesia staffing costs, where a state falls on that list is directly relevant to how much flexibility they have to restructure anesthesia coverage.” * * *
    • “In opt-out states — provided state law and facility policy also allow it — ASCs have more room to build CRNA-based staffing model models. Seattle-based Proliance Surgeons moved to a CRNA-only staffing model in 2025 after the anesthesiology group it was partnered with decided not to renew its contract. After switching the new model, the organization reported no patient care delays and no cases redirected to hospitals over provider-availability concerns.
    • ‘That’s just one case study, but as more states move away from the federal supervision requirement, the staffing-model conversation for ASCs is likely to keep shifting from “how much do we pay for anesthesiologist coverage” to “do we need anesthesiologist coverage for this case mix at all.”
  • The American Hospital Association News notes,
    • “A report on obstetric services in hospitals by the University of Minnesota Rural Health Research Center found that between 2010 and 2024, 718 hospitals nationwide lost obstetric services due to obstetric unit or hospital closure. The report found that 9% of those losses happened from 2023-2024. Between 2010-2024, 14% of hospitals (16% of rural hospitals, 13% of urban hospitals) lost obstetric services, while 35% (42% rural, 30% urban) never had obstetric services during that period. By 2024, 57.5% of rural hospitals and 43.6% of urban hospitals across the U.S. were without obstetric services.” 
  • Healthcare IT News explains how “telemedicine becomes more deeply embedded into hospital workflows.”
    • “Health systems are using virtual nursing, tele-ICU, remote specialty care and EHR-integrated teams to extend scarce expertise, support bedside clinicians and redesign care delivery.”
  • Beckers Physician Leadership discusses the “uneven collapse of private medical practice.”
    • “While the decline of independent practice has persisted as a general trend across medicine, the consolidation of physician practices has played out differently across specialties. 
    • “A 2025 specialty-level breakdown of independent practice published by the American Medical Association found private-practice rates ranging from 70.4% in ophthalmology down to 30.7% in gastroenterology, a nearly 40-percentage-point gap between the most and least independent of the five specialties driving the bulk of physician practice mergers and acquisitions activity.”
  • Fierce Healthcare informs us,
    • “Oura, the smart ring maker and health tracking company, filed to go public on Thursday [September 10] to fuel its next phase of growth as it aims to build an artificial intelligence-powered health platform.
    • “The company has not specified the number of shares to be offered or the price range for the proposed offering. Oura intends to list on the Nasdaq under the ticker symbol “OURA.”
    • “Founded in Finland in 2013, Oura’s smart rings continuously track more than 50 health metrics, including heart rate, sleep, daily movement and activity, stress, fertility windows and metabolic health.”
  • and
    • “Five Kansas health systems have launched a regional collaboration, called Astra Health, to pool resources and coordinate services while retaining their independence. 
    • “The new shared services organization was announced Tuesday and will include LMH Health, The University of Kansas Health System, Amberwell Health, Newman Regional Health and Salina Regional Health Center. Together, the organizations see more than half a million patients annually and extend into every county in the state. 
    • “The partnership will help participating hospitals improve quality, share best practices, enhance performance measurement, and strengthen care delivery in the communities they serve,” Shelly Kortkamp, M.D., president and CEO of LMH Health, said in an announcement.”
  • and
    • “Health tech startup Forus banked $150 million in series C funding as it aims to expand its artificial intelligence-powered network to more medical specialties and care settings.
    • “The fresh funding comes just four months after the company announced it raised $160 million in a series B round. The latest funding round boosts Forus’ valuation to $3 billion, tripling from its series B round in May, according to the company. Forus has raised more than $300 million to date.
    • “Bain Capital Ventures, an investor in Forus since its seed round, led the latest round, with every existing institutional investor reinvesting, including Thrive Capital, General Catalyst, Accel, Redpoint, BoxGroup, Pear VC, Vast Ventures and SV Angel.”
  • Per BioPharma Dive,
    • “BrainChild Bio, a cell therapy developer making CAR-T treatments for children with rare brain cancers, has banked $116 million in a round of venture financing, the company announced Tuesday.
    • “CAR-T therapies are powerful treatments engineered from immune cells. A handful have been approved to treat certain blood cancers, and many companies are studying their potential on other tumors and even autoimmune diseases.
    • “But according to BrainChild founder and Chief Scientific Officer Michael Jensen, few companies have tried to test CAR-T treatments against brain cancer. “The prejudice is that the brain would be intolerant to having cells directly administered,” he said. 
    • “BrainChild is different. Spun out of research at Seattle Children’s Hospital three years ago, the company is working on a pair of brain cancer cell therapies designed specifically for children.”
  • Per Fierce Pharma,
    • “Spying a “golden decade” beyond the branded drug industry’s looming patent cliff, Sandoz is making big bets on its biosimilar capabilities in the coming years. 
    • “Under the company’s so-called Bio100 plan, Sandoz is setting the ambitious goal to establish a portfolio of more than 100 biosimilars by 2040, up substantially from the 13 it currently markets. Meanwhile, the company also aims to expand the overall biosimilar loss of exclusivity (LOE)-value it holds from some 50% today to around 80% from 2035 onwards.
    • “Part and parcel to that, Sandoz hopes to double its net sales from 2025 through the middle of the next decade, according to a Sept. 8 release outlining the strategy. For all of last year, the Swiss drugmaker reported 5% net sales growth at constant currencies to $11.1 billion.” 
  • Tech Target offers “6 use cases for improving employee retention using predictive analytics.”
    • Predictive analytics can identify employees who are good candidates for promotion. Learn other use cases for improving employee retention using predictive analytics.

Happy Labor Day

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

Simplicity is a virtue.

From Washington, DC

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

From the public health and medical / Rx research front

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

From the U.S. healthcare business front,

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

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the frontier AI front,

  • The Wall Street Journal reports,
    • “Nvidia NVDA is planning to use a $6 billion deal it struck this week [August 22] to build one of the world’s most powerful open-weight AI models, one that would compete with Chinese heavyweights like DeepSeek and Kimi K3, according to people familiar with the matter.
    • “The chip giant’s licensing deal with the AI startup Poolside is also set to present a direct challenge to frontier U.S. AI companies including OpenAI and Anthropic, since open-weight models are generally far cheaper to operate and allow easy customization.
    • “Although Nvidia counts big labs like OpenAI and Anthropic as some of its closest partners, the move reflects Chief Executive Jensen Huang’s efforts to position Nvidia for success in multiple AI battlegrounds simultaneously, ensuring the company is able to hold on to its dominant market position.”
  • and
    • Nvidia and CrowdStrike are addressing what they see as one of cybersecurity’s biggest gaps: the need for cyber defenders to harness AI at the velocity of cyber attackers.
    • In the current cyber landscape, frontier AI models are discovering bugs at machine speed—raising alarm bells among experts, who warn that when autonomous hacking models go rogue or attack companies, chaos is on the horizon.
    • But cyber defenders aren’t getting enough of that same AI firepower, according to Nvidia and CrowdStrike, who on Tuesday [September 1] introduced a new family of agentic AI models, dubbed SafeMind, which can both find attack paths and close them for customers. The models are available in CrowdStrike’s flagship Falcon platform and through its API. * * *
    • “SafeMind has two models: Red Tempest, which is an “offensive” model that emulates AI adversaries, and Blue Solano, which is a “defensive” model designed to fix identified issues. The two models are connected by software called a harness, which runs the models in a closed-loop system that pits them against each other for self-improvement.”
  • The New York Times reports,
    • “Nvidia said on Thursday [September 3] that it is buying Hugging Face, a library of open artificial intelligence models, for $12.9 billion, as the chipmaker extends a spending spree in the escalating global race to dominate the technology.
    • “The deal marries Nvidia’s chip and data center infrastructure with Hugging Face’s millions of open-source A.I. models that can be freely downloaded and modified. And it puts Nvidia’s deep pockets firmly on one side of a debate over how A.I. systems should be built.
    • “Together, we will make A.I. more open, more capable and more accessible to people and institutions around the world,” wrote Jensen Huang, the chief executive of Nvidia, in a blog post.
    • “The acquisition is also another sign of Nvidia’s growing role as Silicon Valley’s central banker, using its vast financial resources to bolster A.I. start-ups and funnel money to customers for its chips. With $197 billion in current assets and nearly $60 billion in profits from its most recent quarter, the Silicon Valley giant has been spending heavily on A.I.”
  • Daniel Borish writing in LinkedIn lets us know,
    • “Anthropic released Claude Fable 5.1 and Claude Mythos 5.1 this week, positioning them as its most capable models yet for coding and knowledge work. The two are the same underlying model, split only by the safeguards wrapped around them. Fable 5.1 is generally available. Mythos 5.1 is restricted to vetted cybersecurity and life sciences professionals through trusted access programs run in partnership with the US government.” * * *
    • “On the cybersecurity side, Claude Code users should see roughly 60% fewer safeguard interventions per session, and Fable 5.1 can now be used to find software vulnerabilities, though not to write exploits for them. Tasks like penetration testing, exploit generation, and binary-based vulnerability scanning still route to Anthropic’s Opus models. On biology, updated safeguards reportedly fire 85% less often on benign medical and elementary biology questions, though research-grade life sciences queries still get redirected to Opus, and full access to Mythos 5.1’s biology capabilities is limited to the government-linked Life Sciences Verification Program.
    • “Anthropic’s safety testing found Mythos 5.1 better aligned than its predecessor on several measures it tracks: less likely to seek resources outside its assigned environment when given an impossible task, less likely to reason its way around explicit constraints, and less likely to attempt or succeed at reward hacking. The company also disclosed limits to that picture, noting its behavioral audits have less visibility into very long-context work, multi-agent settings, and testing found the model can still sometimes bypass approval steps and automated review classifiers.
    • “Fable 5.1 also ships with new anti-distillation measures. New API accounts created from launch onward can no longer edit Claude’s prior context in a conversation while preserving the model’s recorded thinking, closing off a publicly documented technique used to extract that thinking at scale.”
  • The Wall Street Journal adds,
    • Anthropic has signed a cloud-computing deal worth $35 billion with NvidiaNVDA 3.21%increase; up pointing triangle-backed cloud provider Lambda, with Nvidia itself holding the lease on the data center, according to people familiar with the deal. 
    • The data center is being developed by Hut 8, a bitcoin miner and data-center developer, in Nueces County, Texas. Nvidia signed an agreement with Hut 8 a few weeks ago to secure the capacity, the people said. 
    • The convoluted arrangement is another example of Nvidia’s growing role in helping non-investment-grade firms such as Anthropic get access to its expensive computing resources. The deal also helped a nascent cloud provider, Lambda, secure a lucrative contract with Anthropic without needing to procure the data-center space on its own. 
    • Lambda will use the data center Hut 8 is developing to plug in chips bought from Nvidia, which is also its investor. It is not clear how much Lambda will pay Nvidia to access the data-center space.
    • Anthropic has been racing to sign cloud-capacity deals after hitting a supply crunch earlier this year that coincided with its products gaining traction. The AI developer signed a $45 billion deal earlier this month with another Nvidia-backed neocloud, Nscale, to rent Nvidia capacity from its West Virginia site, according to people familiar with the deal. 
  • Security Week relates,
    • OpenAI said its newest model, Astra, has reached the ‘Critical’ cybersecurity capability level under the company’s Preparedness Framework, the first time any of its models has been placed in that category. 
    • The designation applies when a model can independently find and exploit zero-day vulnerabilities across many well-defended systems, or carry out a complete cyberattack against a hardened target from only a high-level instruction. OpenAI said the classification requires additional safeguards before the model can be released.
    • In testing described by the company, Astra achieved a perfect score on ExploitBench, a benchmark that measures a model’s ability to turn known vulnerabilities into working exploits. During a separate evaluation involving more recently disclosed flaws, Astra uncovered two zero-day vulnerabilities on its own. 
    • The model also broke out of a browser sandbox to run commands on the underlying machine, and separately chained several flaws in a hardened operating system to gain root-level access.
    • OpenAI reported that Astra now declines 91.5% of cyber-related jailbreak attempts in its testing, up from 59% for its predecessor, GPT-5.6 Sol. The company also said Astra showed far less tendency than Sol to bypass safety restrictions or take advantage of deliberately placed “honeypot” targets during evaluations. 
    • Full cybersecurity capabilities will not be widely available at launch. OpenAI plans to give a group of testers early access, with wider availability to follow through its Daybreak Blue program.
  • Cybersecurity Dive adds,
    • “OpenAI on Thursday [September 3] said it would commit $1 billion in subsidized access and training to help small IT security teams use frontier AI to protect essential services, including electricity, water and local government services. 
    • “The Daybreak for Frontline Defenders program will be used to help defenders search for critical vulnerabilities in their software, hunt for suspicious activity in their technology stacks and stop malicious actions if hackers are able to gain access to their systems.
    • “OpenAI plans to roll out a six-month pilot program with the Multi-State Information Sharing and Analysis Center (MS-ISAC), which will train and support a group of water utilities and other public sector defenders.” 
  • Dark Reading points out,
    • “A new study suggests that while AI is rapidly accelerating vulnerability discovery, enterprise organizations are better equipped to handle the surge than generally assumed.
    • “The key is their ability to quickly validate findings, prioritize risk, and get available fixes into production.
    • “Software supply chain security firm Echo recently analyzed nearly 40,000 CVE life cycles across 250 open source container projects, drawing on a year of its own platform telemetry, survey responses from more than 80 security leaders, and an independent analysis of Anthropic’s Claude Mythos.
    • “The results, detailed in a report titled “Mythos Readiness Report,” show how AI is transforming vulnerability discovery and exploit development — something that security teams have been encountering firsthand over the past year.”
  • and
    • “With multiple benchmarks confirming that at least one frontier model can autonomously execute an end-to-end compromise, cybersecurity experts are warning that companies have to pick up the pace in securing their attack surfaces and adopting AI-speed defenses.
    • “On Sept. 2, consulting firm Booz Allen became the latest organization to confirm that a frontier model — Anthropic’s Mythos 5 — can act as a fully autonomous hacker and compromise a production-grade enterprise network. The company also released a metric, dubbed the Cyber Weapon Index (CWI), to benchmark a model’s capabilities, pairing the ability to find and exploit vulnerabilities with the ability to execute and attack a target.
    • “In their evaluation, Mythos scored an 80, while the next-closest contender, SpaceXAI‘s Grok-4.5, scored a 49. However, the current standings are not as important as where we will be in six months, says Brad Medairy, president of Booz Allen’s National Cyber practice.
    • “Our view is there’s going to be some level of parity, at least between the frontier models and the Chinese models over probably a six-month horizon, and so everyone is in a rapid race to evolve these capabilities,” he says, adding that, when facing human attackers, defenders had the advantage, but “in the future, the balance of power shifts to the offense, because the attacker can deliver effects at speed and scale that the traditional defenses can’t keep pace with.”

From the cybersecurity policy and law enforcement front,

  • Federal News Network reports,
    • “Congress is kicking the can down the road again on a long term debate over reauthorizing the Cybersecurity Information Sharing Act of 2015.
    • “The continuing resolution passed by the House on Tuesday would extend CISA 2015 through the stopgap funding period into early December. The Senate has already passed the measure, meaning it now heads to President Donald Trump’s desk. [FEHBlog note: The President signed the continuing resolution into law on September 2.]
    • “There has been a persistent chorus of voices in industry calling on Congress to find a long-term solution to re-authorizing CISA 2015. Those calls have only grown louder amid advancements in artificial intelligence models and recent cyber attacks on critical infrastructure.
    • “The 2015 law provides privacy and liability protections to encourage companies to share data about cyber vulnerabilities and threats with government and each other. The information sharing law briefly lapsed during last fall’s shutdown and again earlier this year before being extended through Sept. 30.”
  • The Wall Street Journal points out,
    • “The U.S. Defense Department is expected to release its cyber plan as early as Tuesday, NextGov reported, citing people familiar with the matter. The plan is due to outline how the Pentagon will integrate cyber tactics into military strategy, emphasizing offensive actions, and address training requirements. The most recent Defense Department cyber strategy was issued in 2023.”
  • Per a CISA news release,
    • “CISA and the Group of Seven (G7) Cyber Security Working Group released Preparing for the Post-Quantum Era: A Call to Action highlighting the urgent need for organizations and governments to begin transitioning to post-quantum cryptography (PQC) to protect sensitive data, authentication systems, and critical assets from emerging quantum computing threats.  
    • “The G7 Cyber Security Working Group’s call to action outlines five priorities for a successful transition to PQC:
      • “Raising awareness of quantum risks and the importance of PQC;
      • “Developing national strategies that support PQC adoption and integration;
      • “Advancing research and development for quantum-safe technologies;
      • “Fostering public-private partnerships to share expertise and resources; and
      • “Integrating PQC into cybersecurity requirements and procurement processes.” 
  • Cyberscoop relates,
    • “The Trump administration rolled out a six-month test program in Texas on Monday that will draw on volunteer expertise and technology from cyber and artificial intelligence companies to protect the water sector.
    • “Project Watershed 250” is the first of the state-based, industry-centric pilot projects to cross the finish line that the Office of the National Cyber Director has previewedsince the publication of its national cybersecurity strategy earlier this year. Water systems have long been viewed as among the most vulnerable and neediest critical infrastructure sectors, and in recent months the sector has been the victim of a spree of attacks.
    • “Project Watershed 250 is a commitment from the states, industry and federal government that we will continue to prioritize our nation’s safety and deliver on America-first policies for the American people,” National Cyber Director Sean Cairncross said at a rollout event in San Antonio Monday.”
  • and
    • “Sen. Ron Wyden, D-Ore., is asking the National Security Agency to update public guidance on the security risks associated with commercial virtual private networks, and to answer questions about foreign surveillance threats against standard VPNs.
    • “In a letter to NSA Director Gen. Joshua Rudd that Wyden sent Wednesday, the senator continued his push to warn about standard, commercial VPNs, following letters to federal agency leaders in March and July.
    • “While commercial Virtual Private Networks (VPNs) are recommended by federal agencies and widely marketed as shields against online spying, standard consumer VPNs do not sufficiently protect users from sophisticated adversaries,” Wyden wrote in the letter, first reported by CyberScoop. “Other, more secure alternatives are widely available.”
    • “Wyden took aim at “single-hop” VPNs that routes data through one server before arriving at the destination.”
  • Cybersecurity Dive tells us,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) is scaling back the free assessments it offers to critical infrastructure organizations, a move that marks a significant retreat from the agency’s core mission of helping secure the nation’s infrastructure.
    • “CISA’s regional staff will no longer perform its Cyber Resilience Reviews, Cyber Resilience Essentials surveys, Ransomware Readiness Assessments, Incident Management Reviews, External Dependencies Management Assessments or Cyber Infrastructure Surveys, the agency confirmed to Cybersecurity Dive.”
  • and
    • “U.S. law-enforcement agencies and the cybersecurity firm CrowdStrike took down a 23-year-old Russia-based botnet on Monday.
    • “Authorities from the Justice Department, the FBI and the Defense Criminal Investigative Service seized U.S.-based domain namesbelonging to the Sality botnet, while CrowdStrike analysts worked with the agencies to sever infected computers from the botnet. Investigators in Bulgaria, Hungary and Romania also took down Sality domain names in their jurisdictions.
    • “Since 2003, Sality powered spam campaigns, credential-theft operations, distributed denial-of-service (DDoS) attacks and malicious proxy networks. In 2018, the botnet began deploying malware that hijacked cryptocurrency transactions by replacing copied wallet addresses with attacker-controlled ones.
    • “Sality “has been one of the most persistent threats on the internet, not because of its payloads but because of the robustness of its architecture,” CrowdStrike said in its report on the botnet’s takedown.”

From the cybersecurity breaches and vulnerabilities front,

  • Dark Reading reports,
    • “Social engineers are trying to convince companies to make large-dollar transfers to their own accounts, under the guise of fake merger & acquisition (M&A) deals.
    • ‘It’s one of the oldest gambits in cybersecurity — the advance fee scam — for a new generation, and with more on the line. Gen, the parent company of cybersecurity brands Norton and Avast, was targeted by a ruse masquerading as a corporate acquisition. Gen investigated the attempted attack and discovered the company was just one of at least five targets, all of which were at risk of losing massive sums of money.
    • “Social engineers are trying to convince companies to make large-dollar transfers to their own accounts, under the guise of fake merger & acquisition(M&A) deals.
    • “It’s one of the oldest gambits in cybersecurity — the advance fee scam — for a new generation, and with more on the line. Gen, the parent company of cybersecurity brands Norton and Avast, was targeted by a ruse masquerading as a corporate acquisition. Gen investigated the attempted attack and discovered the company was just one of at least five targets, all of which were at risk of losing massive sums of money.”
  • HelpNetSecurity relates,
    • “Attackers are targeting prominent individuals, their relatives and personal contacts to gain persistent access to their accounts, including private emails and files, the FBI has warned.
    • “The FBI’s Internet Crime Complaint Center (IC3) says the activity, which uses a technique called “OAuth consent phishing,” has been ongoing since late 2025. The FBI describes it as “a deceptive, sophisticated approach to access user accounts without requiring a password.”
    • OAuth is a framework that lets one application request access to a user’s account on another service without the user handing over login credentials directly.
    • “Recently observed activity includes impersonating government officials, media, and other publicly known personalities on a commercial messaging application (CMA) and soliciting the targeted individual to access a malicious link under the guise of a file sharing service through an application under the malicious actor’s control,” the FBI wrote in its advisory.”
  • Dark Reading tells us,
    • “A coordinated operation has targeted at least 150 Microsoft Teams users across multiple companies with voice phishing (vishing) attacks aimed at installing remote monitoring and management (RMM) and malware tools onto their machines. The campaign also attempts in some instances to compromise organizations’ domain controllers.
    • “Researchers from Palo Alto Networks observed the operations — which they’ve dubbed “Spring Ring” — between January and April attacking employees across at least 10 organizations, according to a report published this week. The campaign illustrates a growing shift away from traditional email phishing toward attacks conducted through trusted enterprise collaboration platforms, which adds authenticity to the interaction.
    • “The Spring Ring operation represents an evolution from previous campaigns by merging vishing into the Teams workflow,” Noam Sala, a Palo Alto Networks staff researcher, wrote in the post. “This shift moves the attack from a passive click-and-harvest model to a real-time engagement.”
  • The Cybersecurity and Infrastructure Security Agency added ten known exploited vulnerabilities to its catalog this week.
    • August 31, 2026
      • CVE-2026-81578 PaperCut NG/MF Missing Authentication for Critical Function Vulnerability 
      • CVE-2026-82078 PaperCut NG/MF Unsafe Reflection Vulnerability
        • The Hacker News discusses these KVEs here.
    • September 2, 2026
      • CVE-2026-9586 Sangoma Switchbox SQL Injection Vulnerability
      • CVE-2026-48710 Kludex Starlette HTTP Request/Response Smuggling Vulnerability 
      • CVE-2026-49869 Kestra OSS OS Command Injection Vulnerability 
      • CVE-2026-59822 BerriAI LiteLLM Improper Authentication Vulnerability 
      • CVE-2026-82329 JFrog Artifactory Improper Authentication Vulnerability 
      • CVE-2026-83548 SonicWall SMA1000 Appliances Server-Side Request Forgery Vulnerability 
      • CVE-2026-83549 SonicWall SMA1000 Appliances OS Command Injection Vulnerability 
        • Cybersecurity Dive discusses the SonicWall KVEs here.
        • ePlanetSecurity discusses the Sangoma KVE here.
        • AssurePort discusses the Kludex KVE here.
        • Sentinel One discusses the Kestra KVE here.
        • CSurface discusses the BerriAI KVE here.
        • Security Week discusses the JFrog KVE here.
      • September 4, 2026
        • CVE-2026-85046. Google Chromium V8 Type Confusion Vulnerability\
          • The Hacker News discusses the Google KVE here.
  • Security Week tells us,
    • “Anthropic has warned some Claude users that infostealer malware on their computers allowed attackers to hijack login sessions and run up usage limits, according to an email the company sent to affected customers. 
    • “The company said it detected the activity, signed out the compromised sessions, and removed saved payment methods from affected accounts as a precaution.
    • “Anthropic is alerting Claude AI users whose computers were infected with infostealer malware such as Vidar, Lumma, StealC, RedLine, and Acreed on Windows, along with Atomic Stealer (AMOS) on a small number of macOS devices.
    • “The AI giant emphasized that the malware is general-purpose and not tied to Claude itself, typically arriving via unofficial downloads or malicious apps.” 

From the ransomware front,

  • HIPAA Journal reports,
    • “Data breaches have been confirmed by Alta Orthopaedics in California, Cornerstone Behavioral Healthcare in Maine, Cameron Regional Medical Center in Missouri, Suntree Internal Medicine in Florida, and Associated Endocrinologists in Michigan. Ransomware groups have claimed responsibility for the attacks.”
  • The Register adds,
    • “US hospital operator Nutex Health says attackers stole private or confidential patient, employee, provider, business, and financial information during the cyberattack it disclosed last week.
    • “In an updated filing submitted to the Securities and Exchange Commission (SEC) on Monday, Nutex also said an unauthorized third party had threatened to publish the stolen information.” * * *
    • “Nutex did not identify the intruders. However, The Gentlemen ransomware-as-a-service (RaaS) operation added the company to its leak site on Monday and claimed responsibility for the attack.
    • “The gang offered no evidence or details to substantiate its claim. Naming victims on a leak site and threatening to publish their data is a standard pressure tactic in double-extortion attacks.”
  • InfoSecurity Magazine relates,
    • “Aurora ransomware actors have been observed abusing SpaceX’s AI Cursor Agent as part of exploitation campaigns, according to a new study by Gambit Security’s Threat Intelligence team.
    • “The threat actors ran Claude Sonnet through Cursor Agent to assist with various exploitation activities against 10 victims between April 8 and May 26, 2026.
    • “These tasks included scanning the victim’s environment for reconnaissance purposes, installing a VPN client and running certificate attacks.
    • “While Cursor Agent did not always achieve its stated objectives, the research demonstrated how threat actors are continuously experimenting with AI tools to speed up and enhance their campaigns.
    • “Cursor Agent is used by software developers to complete complex coding tasks independently, run terminal commands and edit code.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • “Palo Alto PANW Networks swung to a loss in the fiscal fourth quarter, but posted higher revenue and projected double-digit revenue growth in the current fiscal year as customers continue to boost their cybersecurity spending in response to advancements in artificial-intelligence.
    • “The cybersecurity company on Tuesday [September 1] said it is expecting revenue to rise between 23% and 24% to $14.1 billion to $14.2 billion in fiscal 2027. Analysts polled by FactSet are expecting $13.84 billion in revenue.
    • “Chief Executive Officer Nikesh Arora said the results and outlook reflect growing recognition among enterprises that they need to modernize their cyber defenses to meet the capabilities of ever-more-powerful AI models, especially following the release of Anthropic’s Mythos earlier this year.
    • “In that context, people are gravitating towards the largest players in the industry and looking at us to provide the antidotes to this development in AI,” Arora said in an interview.”
  • and
    • Zscaler ZS posted a narrower loss after revenue rose 25% in its fiscal fourth-quarter, as artificial intelligence helps drive demand for its cybersecurity offerings.
    • The San Jose, Calif.-based company also said it would restructure and cut 3% of its workforce as it reallocates resources to support its AI and growth initiatives.
    • Zscaler on Thursday [September 3] reported a loss of $3.37 million, or 2 cents a share, compared with a loss of $17.6 million, or 11 cents a share, a year earlier.
    • Adjusted earnings were $1.19 a share. Analysts were looking for $1.09 a share, according to FactSet.
  • and
    • “Blackstone is placing an early bet on Huskeys, a cybersecurity startup building an artificial intelligence gatekeeper to protect companies from the growing chaos of automated web traffic.
    • “The firm’s early-stage venture-capital arm, Blackstone Innovations Investments, led a $27 million Series A investment that values the year-old company at more than $100 million.
    • “The deal makes Blackstone the second-largest outside investor in Huskeys, behind Israeli venture-capital firm 10D, according to a Huskeys representative. So far, investors have put $35 million into the startup.
    • “Other backers in the most recent transaction include the investment arm of publicly traded cybersecurity company Zscaler and Bright Pixel Capital, the venture arm of Portuguese retailer Sonae.
    • “New York-based Huskeys was founded in Tel Aviv in 2025 by Itai Gafni and Roy Weisfeld, veterans of the Israeli army’s elite Unit 8200 cybersecurity division. Gafni is Huskeys’ chief executive and Weisfeld is its chief technology officer.”
  • Tech Crunch offers a tip
    • “How to find cyber-risk data sources for a FAIR analysis
      • “Cyber-risk quantification with FAIR can change the game for CISOs — but sourcing enough accurate data for analysis can feel impossible. Learn how and where to find it.”
      • “The Factor Analysis of Information Risk (FAIR) model is a widely respected, mathematically based open standard for CRQ that enables CISOs to translate cyber-risk into financial risk. One of the biggest challenges of using the FAIR model, however, is that its analytical output is only as good as its data inputs — and finding accurate data to feed the model is not always easy or intuitive.”
  • Per a CISA news release,
    • “Developed by CISA, the Federal Bureau of Investigation, and international partners, this guidance describes how organizations can plan and execute clear, timely, accurate, and audience-appropriate communications during IT and operational technology (OT) outages. Whether caused by cyber threat actors, human error, equipment failure, or natural hazards, service outages can create disruption and societal panic even without speculation from end users and the public as added factors. Outages at one organization may cascade across interconnected systems, increasing uncertainty and alarm. The guidance emphasizes clarity, accountability, and transparency as core principles and details key elements of effective crisis messaging to inform affected stakeholders and the public while aligning with legal requirements, operational security, law enforcement, and containment efforts. 
    • “CISA’s CI Fortify initiative provides information and resources that help critical infrastructure organizations prepare to isolate and recover vital OT systems during a major cyber incident or crisis. Changes in service availability, whether from outages or isolation as a defensive strategy, require transparent and ongoing communication to help end users minimize operational impact, limit speculation, and preserve trust. For emergency planning purposes, critical infrastructure owners and operators should assume that telecommunications services may be disrupted or otherwise unreliable, making it crucial for organizations to have crisis communications plans in place that integrate backup communication methods and understand the type of communication they should expect from their service providers.”
  • Cyberscoop explains why judgment is emerging as cybersecurity’s defining skill.
  • Here’s a link to Dark Reading’s CISO Corner.