Midweek update

David Ermer

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

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, 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.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Hill reports,
    • “Bipartisan House lawmakers, including two battleground Republicans, introduced legislation Thursday to ensure people with private health insurance don’t pay more than $35 a month for insulin. 
    • “Lawmakers have discussed the idea of an insulin cap for years but haven’t been able to get legislation over the finish line over GOP resistance to government setting prices.  
    • “But two Republicans in contested battleground districts signing on shows that the GOP is trying to address concerns about the cost of healthcare ahead of the midterm elections.  
    • “The Insulin Act — shorthand for the Improving Needed Safeguards for Users of Lifesaving Insulin Now Act — was introduced by Reps. Diana DeGette (D-Colo.), Angie Craig (D-Minn.), Kim Schrier (D-Wash.), Mariannette Miller-Meeks (R-Iowa) and Rob Bresnahan (R-Pa.). 
    • “It’s a companion version of legislation that advanced through the Senate Health Committee earlier this summer. That bill is being pushed by Sens. Susan Collins (R-Maine), Jeanne Shaheen (D-N.H.), Raphael Warnock (D-Ga.) and John Kennedy (R-La.). In total, it has 28 co-sponsors divided equally between the parties.” 
  • Beckers Payer Issues relates,
    • “House Democrats are discussing a healthcare policy agenda that could include an expansion of the Medicare program, the Washington Post reported Sept. 3.
    • “House Minority Leader Hakeem Jeffries told NBC News that reversing the Medicaid cuts under H.R.1 and reviving enhanced ACA premium tax credits have “uniform Democratic support” ahead of the midterms. But privately, members have been discussing a broader expansion of Medicare, including widening eligibility, adding new benefit categories and capping enrollee costs, as well as creating some form of public insurance option, according to the Post, citing four people familiar with the discussions. 
    • “Breaking up vertically integrated healthcare companies like UnitedHealth Group and CVS Health is also under discussion, the Post reported, mirroring a theme that has drawn bipartisan support in Congress since January’s hearings with the CEOs of major insurers.
    • “Other policy ideas Democrats are reportedly looking at are cracking down on Medicare Advantage billing practices they say are fraudulent, expanding Medicare’s authority to negotiate drug prices beyond the current scope under the Inflation Reduction Act, passing a federal right to abortion and providing public coverage to people up to 26 years old.”
  • and
    • “CMS has rebranded individual coverage health reimbursement arrangements to CHOICE Arrangements, or Custom Health Option and Individual Care Expense.
    • “The new name for the alternative health insurance model was announced Sept. 3 by CMS Administrator Mehmet Oz, MD, at an event in Indiana.
    • “ICHRAs let employers give workers a fixed, tax-free amount to buy their own individual health insurance on or off the exchange instead of offering a traditional group plan. The number of people covered by ICHRAs surpassed 500,000 at the start of 2026, according to the HRA Council.”
  • Beckers Hospital Review adds,
    • “States are earmarking specific slices of their Rural Health Transformation Program dollars for technology upgrades, service expansions and workforce pipeline development.
    • “[As noted in the FEHBlog] CMS has announced 15 such efforts over the past month. Each state’s full fiscal year 2026 award was set in December 2025, when CMS approved $50 billion in Rural Health Transformation Program funding across all 50 states. The entries below represent specific initiatives or sub-awards within those existing awards — not new money on top of them.
      • New York — $76 million. CMS said Sept. 4 the funding will strengthen coordination among rural hospitals, primary care providers, federally qualified health centers and behavioral health providers, and expand clinical training programs for the rural workforce.
      • Michigan — $25 million. The funding will modernize healthcare technology, expand telehealth and remote patient monitoring capabilities, and improve high-speed internet connectivity in rural areas, according to a Sept. 4 news release. 
      • Rhode Island — $5.48 million. CMS announced Sept. 4 that the funding will expand career and technical education in healthcare fields at 14 local education agencies and schools, building student pathways into nursing, EMS, behavioral health and other high-demand professions.
  • 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 awarded $11.2 million to support the development of 15 new physician residency programs in rural communities across 14 states. The Rural Residency Planning and Development (RRPD) Program awards will create new residency programs in family medicine, internal medicine, preventive medicine, psychiatry, and general surgery, helping to strengthen the health workforce in rural and tribal communities.
    • “Where you live should not determine whether you can find a doctor,” said HHS Secretary Robert F. Kennedy, Jr. “We are bringing physician training directly into rural and tribal communities, where doctors are needed most. By training physicians in these communities, we can build a stronger local workforce, expand access to care, and ensure rural families can get the care they need close to home.”
    • “Since the RRPD program was established in 2019, HRSA has invested nearly $77 million across 36 states and one territory to build a pipeline of physicians trained in rural communities. As of July 2026, these investments have resulted in 66 accredited rural residency programs, 818 approved residency positions, and more than 850 resident physicians enrolled in rural training settings.”

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

  • Federal News Network reports,
    • “Agencies may get more flexibility in disciplining federal employees, after the Merit Systems Protection Board finalized a rule ending decades-old standards for reviewing misconduct cases.
    • “MSPB on Thursday lifted a requirement to consider the “Douglas factors” in every employee misconduct case — 12 considerations the board has used for the last 45 years to determine whether a penalty, such as a firing or demotion, was reasonable.
    • “Once the final rule takes effect in 30 days, MSPB will evaluate whether an agency’s penalty for an employee accused of misconduct was reasonable on a case-by-case basis rather than reviewing all 12 considerations listed under the Douglas factors.
    • “Stemming from a 1981 Department of Veterans Affairs case, MSPB has relied on the Douglas factors in reviewing misconduct appeals, looking at the seriousness of the offense, the employee’s disciplinary record, and the potential for the employee to be rehabilitated, among other considerations.”
  • and
    • “Federal employees traveling for business will see a slight bump in their daily reimbursable allowance, according to new per diem rates set by the General Services Administration.
    • “Starting Oct. 1, employees on official travel will see a $3 increase in the standard lodging per diem rate, from $110 to $113, GSA announced last month. Allowances for meals and incidental expenses (M&IE) will remain between $68 and $92 for the upcoming fiscal year, with the lower end of that range serving as the standard base rate.
    • “Agencies use per diem rates to reimburse federal employees for lodging, meals and other expenses during official travel. GSA announces the government’s per diem rates each August, ahead of the upcoming fiscal year.”

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns who cannot receive nutrition by mouth or through a feeding tube.
    • “The FDA became aware of the potential supply gap after children’s hospitals raised concerns about continued access to neonatal starter parenteral nutrition. The concerns were based on the discontinuation of certain standardized neonatal starter PN products made by two outsourcing facilities that are permanently shutting down.
    • “The FDA is committed to deploying every regulatory tool available to prevent critical supply chain gaps from threatening patient care,” said Acting FDA Commissioner Kyle Diamantas, J.D. “We are working closely with healthcare providers and industry partners to help ensure that vulnerable populations continue to have access to the care they need.”
  • and
    • “The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.
    • “FDA granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy, based on an FDA-authorized test.
    • “ESR1 mutations are acquired resistance mutations that a tumor may develop during treatment with an aromatase inhibitor, a type of endocrine therapy that is a common front-line treatment for locally advanced or metastatic breast cancer. At the diagnosis of HR-positive metastatic breast cancer, fewer than 5 percent of patients will have this tumor mutation. After disease progression on an aromatase inhibitor, nearly 40 percent of patients will have this tumor mutation.
    • “Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment. We owe them every weapon in our arsenal.” said Acting FDA Commissioner Kyle Diamantas, J.D. “Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”
  • Cardiovascular Business relates,
    • “Powerful Medical, a New York-based medtech company, has been granted De Novo authorization from the U.S. Food and Drug Administration (FDA) for an artificial intelligence (AI) model designed to detect signs of an ST-elevation myocardial infarction (STEMI) in electrocardiography results.
    • “The newly authorized AI model, Queen of Hearts, can flag STEMI as well as STEMI equivalents. It was trained by Stephen W. Smith, MD, an emergency physician at Hennepin County Medical Center. The technology already gained European CE mark approval and it received the FDA’s breakthrough device designation in March 2025. Approximately seven months later, new data on Queen of Hearts was presented at TCT 2025 in San Francisco and simultaneously published in JACC: Cardiovascular Interventions.[1] That study linked the advanced AI model to a significant improvement in heart attack detection and a reduced risk of false-positive alerts.
    • “With this FDA authorization in place, Powerful Medical is now ramping up the deployment of its PMcardio platform, which can embed Queen of Hearts—and other algorithms when desired—into existing clinical workflows.” 

From the judicial front,

  • Per a Department of Justice news release,
    • “Two Florida men were sentenced to multiple years in prison for their roles in a $34.8 million health care fraud conspiracy billing Medicare for thousands of orthotic braces sent to Medicare beneficiaries who did not need them.
    • “These fraudsters billed Medicare $34.8 million for braces that patients didn’t need and didn’t request — and now they’re paying the price,” said Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division. “They paid kickbacks for fake doctors’ orders, shuffled billing among several companies to dodge payment suspensions, and pocketed millions that belonged to American taxpayers. Their prison sentences make clear: if you steal from Medicare, you will be caught, you will be prosecuted, and you will be held accountable.”
    • “According to court documents, Kenneth Charles Kessler III, 43, of Miami, Florida, and Michael Andrew Gomez, 43, of Miramar, Florida, owned and operated seven durable medical equipment (DME) supply companies based in Florida. Through these DME companies, they submitted millions of dollars in false claims to Medicare for medically unnecessary orthotic braces.
    • “Kessler and Gomez also paid illegal kickbacks and bribes to obtain fraudulent signed doctors’ orders. They used these orders to ship orthotic braces to Medicare beneficiaries nationwide, including to beneficiaries who neither requested nor needed the braces, and then claimed payment for those braces from Medicare. Kessler and Gomez used their multiple DME companies to evade Medicare payment suspensions by shifting their fraudulent billing between their DME companies.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 4, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
      • “National and regional COVID-19 activity is increasing.
      • “RSV activity is very low in most areas of the country.
      • “Seasonal influenza activity is low.
      • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
  • Yahoo adds,
    • “As the most up-to-date vaccines are set to come out, Texas has experienced rising rates of COVID infection, data suggests. 
    • “Wastewater COVID readings in Texas have surged well beyond the national average, starting in July, according to data from the Centers for Disease Control and Prevention. 
    • “The state’s wastewater viral activity level hovered a little above the U.S. average through most of June. It crested twice in the summer before reaching the CDC’s “very high” threshold during the week ending Aug. 22, the latest date for which data is available. 
    • “Texas was the only state in the nation with “very high” wastewater COVID levels as of Aug. 22. Wastewater data can alert public health officials to rising illness beyond other indicators, like positive test rates, ER visits and deaths, which have limitations due to how they’re collected.”
  • Per a Walgreens news release,
    • “Walgreens is now offering 2026-2027 COVID-19 vaccines for eligible patients.1 With multiple viruses and seasonal illnesses expected to circulate this fall and winter, Walgreens is making it easy for patients to stay protected by offering COVID-19, flu, RSV, pneumococcal and other recommended vaccines during a single visit. 
    • “Patients can walk into their local Walgreens pharmacy or schedule an appointment at Walgreens.com/ScheduleVaccine, through the Walgreens app, by texting “Flu” to 66879 or by calling 1-800-WALGREENS in most states. 
    • “As respiratory virus season ramps up, many people are thinking about how to protect themselves and their loved ones,” said Rick Gates, chief pharmacy officer, Walgreens. “Getting multiple recommended vaccines at the same time is a safe and effective way to reduce the risk of illness and help protect yourself, your family and your community heading into the fall and winter. Our goal is to make getting vaccinated as convenient as possible so patients can save time and stay protected.” 
  • MedPage Today tells us,
    • “Viral persistence is thought to be a possible cause of long COVID.
    • “In this phase II trial, nirmatrelvir-ritonavir (Paxlovid) — which is approved for acute COVID-19 — was no better than placebo-ritonavir at reducing long COVID symptoms.
    • “The NIH-sponsored study included participants with cognitive, autonomic, and exercise phenotypes.”
  • The University of Minnesota CIDRAP reports,
    • “Today, the CDC updated the country’s measles case count, which stands at 3,134, including the two Pennsylvania deaths. Eight percent of measles patients have been hospitalized. 
    • “Of the total, 231 infections are new. That compares with 126 new cases last week.
    • “Of all cases, 94% occurred in people who were unvaccinated or had an unknown vaccination status. All cases but 16 were locally transmitted. In all of 2025, 2,289 measles case were confirmed in the United States.
    • “In Pennsylvania, officials today added 115 new cases—about half of all new US infections—from the past week to its state case tally, raising it to 577 cases. None of the state’s cases involve people fully vaccinated against the virus. In total, 98 people (17%) have been hospitalized. Thirty percent of infections occurred in children.
    • “The Pennsylvania Department of Health also warned that travelers at the New Stanton Service Plaza on the westbound Pennsylvania Turnpike in Westmoreland County may have been exposed to measles by a person from another state who stopped at the plaza on August 17 and later tested positive for the virus.
    • “On the cusp of the Labor Day weekend, which entails travel for many people, healthcare professionals are urging travelers to be vigilant in monitoring for symptoms of the highly contagious disease, such as rash, fever, and red, watery eyes.
    • “Ohio is reporting 15 new cases, including five cases in Wayne County, amid its third measles outbreak of the year, raising its tally for the year to 122.” 
  • and
    • “For the fourth year in a row, the number of US teenagers being vaccinated against human papillomavirus (HPV) has not increased, according to survey results published yesterday in Morbidity and Mortality Weekly Report. 
    • “A smaller percentage of adolescents received the HPV series compared with recipients of the tetanus, diphtheria, and pertussis (whooping cough) vaccine (Tdap) and the conjugate meningococcal vaccine against the A, C, W, and Y strains (Men ACWY). But uptake of these immunizations declined slightly from last year. 
    • “The consistently lower HPV vaccination coverage compared with other routine adolescent vaccines might, in part, reflect differences in school entry requirements,” wrote the authors, from the Centers for Disease Control and Prevention (CDC). “Tdap is required for school entry in all states, and MenACWY is required in most states; however, few states require HPV vaccination.” * * *
    • “Continued efforts are needed to increase adolescent vaccination coverage with recommended vaccines and reduce geographic differences in coverage, particularly with HPV vaccine,” the authors wrote. “Efforts to address barriers to vaccination, including improving access to preventive care, strengthening provider communication regarding recommendations, and increasing vaccine confidence, could help improve coverage.”
  • The Washington Post offers a look at “The behind-the-scenes effort to contain the nation’s worst ongoing measles outbreak.”
    • Public health workers are relying on word of mouth to fight the largest ongoing outbreak in the United States.
  • Beckers Clinicial Leadership informs us,
    • “Two patients who received genetically engineered pig kidney transplants at Somerville, Mass.-based Mass General Brigham have since successfully undergone human donor kidney transplants, Cambridge, Mass.-based eGenesis said in a Sept. 3 update on its Expanded Access program.
    • “The cases mark the first reported transitions from xenotransplantation to allotransplantation, according to eGenesis, and provide early evidence that a genetically engineered pig kidney can bridge patients to a human donor organ.”
  • and
    • “Death rates from cancers associated with alcohol consumption doubled between 1990 and 2023, according to a study published Sept. 2 in The Lancet Regional Health — Americas. 
    • “Led by the Sylvester Comprehensive Cancer Center at the University of Miami, researchers used the Global Burden of Disease database to analyze age-standardized mortality rates for all cancers and 10 specific cancers, and the percentage of those rates that could be attributed to heavy alcohol use, between 1990 and 2023.”
  • Health Day points out,
    • “A person’s memory starts to get worse much sooner than previously thought, a new study says.
    • “Folks in their 50s start showing signs of decreased memory function, likely due to changes in the brain region responsible for stabilizing memories, researchers reported recently in the journal Cerebral Cortex.
    • “This is one of a growing list of studies highlighting that the period of middle age is really important for memory functioning and shouldn’t be ignored,” senior researcher Ian McDonough, an associate professor of psychology at Binghamton University in New York, said in a news release.”
  • and
    • “Simple walking tests could be an easy way to assess the well-being of a patient with multiple sclerosis (MS), a new study says.
    • “Better walking performance and higher levels of daily physical activity are linked to better quality of life among people with intermittent forms of MS, researchers report in the October issue of the journal Multiple Sclerosis and Related Disorders.
    • “These findings reinforce previous research and highlight the potential benefits of maintaining an active lifestyle,” lead author Marko Luostarinen, a doctoral researcher at the University of Eastern Finland, said in a news release.”
  • Per BioPharma Dive,
    • “AbbVie said its dual-acting drug for multiple myeloma met the main goal of a Phase 3 clinical trial, helping people who’ve progressed on two or more lines of therapy survive longer without progression than those who received standard treatment regimens, the company said Thursday.
    • “The drug, called etentamig, could be safer than rival drugs launched by Johnson & Johnson, Pfizer and Regeneron, with low rates of two kinds of serious immune responses common to other drugs of its type. AbbVie said its safety profile could enable greater use in community oncology centers because of reduced need for post-treatment patient monitoring.
    • “Etentamig is a type of drug called a bispecific antibody that can simultaneously bind to diseased tumor cells and T cells, triggering an immune response to fight multiple myeloma. It trails by more than four years the first drug in its class, J&J’s Tecvayli, which booked $462 million in sales through the first six months of 2026.”
  • The Wall Street Journal notes,
    • “Bristol Myers Squibb told regulators, researchers and patient-advocacy groups in early June that it had paused closely watched drug research because of life-threatening side effects. It took three months for the company to share that with the broader public.
    • “Novartis paused research into a similar therapy last month, which it confirmed only after a Wall Street analyst noticed while scouring a database. It took a week for the company to reveal that three study patients had died.
    • “Novartis and Bristol Myers are both studying their own new forms of faster-to-produce CAR-T therapy for autoimmune diseases, a promising new area of drug research that re-engineers a person’s own cells to attack disabling conditions such as lupus or rheumatoid arthritis.”
  • Per Genetic Engineering and Biotechnology News,
    • “A cancer drug designed to push malignant cells toward death may also help researchers chip away at one of the toughest barriers to curing HIV: the long-lived viral reservoir that persists despite antiretroviral therapy.
    • “In a study titled, “BCL-2 inhibition at antiretroviral therapy initiation reduces the intact SIV reservoir in macaques,” and published in Nature Microbiology, researchers at Emory University reported that a short course of venetoclax, a BCL-2 inhibitor approved for certain blood cancers, reduced the intact simian immunodeficiency virus (SIV) reservoir in rhesus macaques when given at the start of antiretroviral therapy (ART). SIV infection in macaques is commonly used as a nonhuman primate model for studying HIV persistence and cure strategies.”

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

  • Modern Healthcare reports,
    • “Cambia Health Solutions’ strategic affiliation with Arkansas Blue Cross and Blue Shield has been approved by state regulators.
    • “The deal will take effect Oct. 1, according to a Friday news release from the companies.
    • “Cambia, which operates Regence Blue Cross plans in Idaho, Oregon, Utah and Washington, in February completed a similar affiliation with Blue Cross Blue Shield of North Dakota.
    • “Arkansas Blue Cross will retain its regional brand name, local board and philanthropic foundation, and its reserve funds and foundation resources will stay in the state, according to the news release. 
    • “Curtis Barnett will remain president and CEO of Arkansas Blue Cross, with Jared Short still president and CEO of Cambia, a Cambia spokesperson said Friday. No assets will be transferred.
    • “The affiliation will enable the companies to pool resources and develop new technology and care management services, executives said in November.” 
  • The Wall Street Journal relates,
    • “Most people do not appeal health insurers’ prior authorization denials, even though many who do are successful.
    • “Successful appeals require doctors to provide precise diagnosis details and authoritative medical information to counter insurer objections.
    • “Patients can appeal denials for drugs not on a formulary list or for step therapy requirements by providing medical records.”
  • Beckers Hospital Review tells us,
    • “Lebanon, N.H.-based Dartmouth Health recorded an operating loss of $22.9 million (-2% operating margin) in the third quarter of fiscal year 2026, compared to operating income of $47.7 million (4.3% margin) during the same period last year, according to its Aug. 28 financial report. ” * * *
    • “Dartmouth-Hitchcock Medical Center — its flagship hospital — has implemented a financial resiliency plan aimed at increasing patient access and reducing costs to improve its ongoing operating margin. The system engaged an external consultant in the second half of fiscal year 2026 to accelerate the plan and identify additional margin opportunities systemwide.”
  • Beckers ASC Review informs us,
    • “CMS’ 2026 Hospital Outpatient Prospective Payment System and ASC Payment System Final Rule marked the largest single-year expansion of outpatient-eligible surgery since at least 2018, surpassing, in one year, the 59 procedures Becker’s tracked as added to the ASC-covered list over the entire five-year span from 2018 to 2023. 
    • “Two policy changes drove it: a revision of the ASC covered procedures list criteria, and the start of a three-year phase-out of the inpatient-only list. CMS finalized the addition of 289 surgical procedures to the ASC covered procedures list for CY 2026, and separately added 271 of the codes removed from the inpatient-only list to that same list. Combined, more than 500 procedures became newly eligible for the outpatient/ASC setting in a single year.
    • [The article provides] a breakdown of the newly eligible procedures by specialty.
  • Healthcare Innovation lets us know,
    • “A five-year reimbursement horizon allows health systems to plan and invest in building comprehensive Hospital at Home programs.
    • “Workforce development and training are identified as major challenges, requiring new curricula and integration into the healthcare workforce.
    • “Technology must be designed around patient needs, with passive data capture and seamless EHR integration being key priorities.
    • “Implementation science is crucial to understanding why some programs scale successfully while others remain small.
    • “Hospital at Home is not suitable for all patients; careful patient selection and problem-focused planning are essential for success.”
  • Healthcare Dive points out,
    • “Adena Health has acquired Fairfield Medical Center, months after federal regulators scrutinized its previous planned merger with OhioHealth, the state’s largest health system.
    • “The Federal Trade Commission said Fairfield and OhioHealth scrapped their merger plans after an investigation concluded that a merger between the two systems would violate antitrust guidelines and negatively affect the quality and cost of care.
    • “Now, federal regulators are praising Fairfield’s new deal, which closed on Tuesday. “Today’s announcement should serve as a reminder that we will stop bad hospital deals,” Daniel Guarnera, Director of the Federal Trade Commission’s Bureau of Competition said in a Wednesday statement.”
  • Per Fierce Pharma,
    • “Total prescriptions for Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo both grew over the past week, reaching roughly 181K (+3%) and 44K (+8%), IQVIA data showed, as cited by Citi. Both numbers are the two meds’ highest so far. 
    • “While Foundayo has yet to catch up with the Wegovy pill, the market share gap between the two oral drugs is slowly narrowing. According to an Aug. 28 Jefferies note based on data the previous week, Foundayo’s share of new prescriptions (NRx), which exclude refills, was 21.5% in the oral obesity market.
    • “Back to the most recent week, the Wegovy pill’s position within the Wegovy family remained stable at 35%, as total Wegovy scripts increased 2.7% sequentially to 513.5K. During the same period, Lilly’s Zepbound scripts climbed 1.6% to a little fewer than 772K.” 

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “House Republicans are scrapping the last two weeks the chamber was scheduled to be in session before the midterm elections.
    • “Under the revised schedule announced Thursday, the House will return for votes the evening of Monday, Sept. 14, a week after Labor Day, for what is now expected to be only a one-week session before members return to their home districts.
    • “President Donald Trump signed a stopgap spending bill on Wednesday that will keep the government open through Dec. 11, which some argue has essentially negated the need for an extended September session. 
    • “I don’t think there’s any probably compelling reason that we need to be here” late in the month, said Rep. Robert B. Aderholt, R-Ala., a House appropriator.
    • “I think everybody’s so focused on the election at this point that we’ll just have to wait till the election’s over,” he added, when asked about passing more of the House’s fiscal 2027 spending bills.”
  • FEHBlog observation — September 14 also is the first day that the Senate returns from its State work break.
  • Fierce Healthcare relates,
    • “A leading Democrat in the House is probing the behavior of No Surprises Act arbiters.
    • Energy and Commerce Committee Ranking Member Frank Pallone, D-New York, sent letters to six certified independent dispute resolution (IDR) entities, seeking details on how each of them is conducting arbitration and staying in compliance with the law as IDR payouts rise.
    • “Pallone’s office sent letters to C2C Innovative Solutions, Inc.; Commence; Dane Street, LLC; EdiPhy Advisors, LLC; National Medical Reviews, Inc.; and ProPeer Resources, LLC on Thursday, per an announcement.
    • “In the letters, he notes the rising number of surprise medical bills that are reaching IDR, rather than being resolved in negotiations, and escalating payments for services resolved through arbitration. A study released in August by researchers at the Georgetown University Center on Health Insurance Reforms estimated that costs related to IDR reached $22.4 billion at the end of 2025.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $120 million investment is being delivered to strengthen rural health and expand access to high-quality care for Hoosiers through the federal Rural Health Transformation Program (RHTP). These investments will support locally driven solutions across eight regions of the state including removing barriers to technology, transportation, and health education. They will provide nutritional support and counseling with community-specific pilot programs that will address the impact food and nutrition have on health and healthcare. This funding will also help address prevention and management of chronic conditions such as diabetes and obesity.
    • “This investment will strengthen maternal and infant health services, expand access to primary and behavioral health care, and provide critical mental health and crisis response resources. It will also help build the next generation of the rural health workforce through expanded recruitment, training and retention efforts, while creating a coordinated transportation network to help patients get to the care they need.” 
  • Beckers ASC Review lets us know,
    • The Federal Trade Commission has widened its scrutiny of healthcare deal-making and dominant vendors over the past month, touching hospital M&A, ASC consolidation and the EHR  market in quick succession. 
    • [The article points out] three recent FTC moves to know.

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

  • Tammy Flanagan, writing in Govexec, discusses reliable rules for your retirement recordkeeping.
  • Ronald Sanders, a NAPA fellow, former OPM associate director and former agency CHCO, writing in Federal News Network, “explains why federal HR leaders should be treated like adults and held accountable.”

From the Food and Drug Administration front,

  • Eating Well reports,
    • “The FDA recalled 75,250 packages of Hodo’s Chili Crisp Lightly Fried Tofu due to potential contamination.
    • “The 8-ounce packages contain UPC 850565007842 and contain use-by dates from May 15 through November 7, 2026.
    • “The recall affects 29 states; check your fridge and return or dispose of affected tofu for a refund.
    • “The tofu may contain ink; seek medical care if you are experiencing any health concerns.”
  • Per FDA news releases,
    • “As part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation, the U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
    • “Botanical drug products are products that include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials and are intended to diagnose, cure, mitigate, treat or prevent disease. While there is broad interest in botanical products, their inherent complexity and variability can present unique challenges for research, product development and regulatory review.” * * *
    • “The public will have 60 days following publication in the Federal Register to submit comments to the docket. Stakeholders are encouraged to submit comments electronically at https://www.regulations.gov by searching for Docket No. FDA-2026-N-9550, entitled “Advancing Development of Botanical Drug Products; Request for Information.”  Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
    • “The comment period closes November 3, 2026.”
  • and
    • “The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients. Zanvastro is the first FDA-approved treatment for Alexander disease and the first therapy to directly target the protein buildup that drives the disease.
    • “For patients with Alexander disease and their families, there have been no approved treatment options — only supportive care while the disease progresses,” said Emily Freilich, M.D., Director of the Division of Neurology I in the FDA’s Center for Drug Evaluation and Research. “Today’s approval is a landmark moment for this community, offering the first therapy that addresses the underlying cause of this rare and serious disease.”
    • “Alexander disease is a rare, progressive neurological disorder caused by mutations in the gene that produces glial fibrillary acidic protein (GFAP). When this protein is abnormal, it accumulates in the brain’s supportive cells, causing damage to the nervous system over time. The disease affects less than 1 in a million people and can cause a wide range of serious and potentially life-threatening problems, including seizures, loss of developmental milestones, difficulty walking, muscle weakness, and increased pressure in the brain.
    • “Zanvastro is an antisense oligonucleotide — a type of medicine that works by reducing the production of the abnormal GFAP protein before it can accumulate and cause further damage. It is administered as an injection into the spinal canal every three months by a trained healthcare professional.”
  • Cardiovascular Business adds,
    • “Boston Scientific is warning clinicians about an ongoing safety concern with its LUX-Dx family of insertable cardiac monitors (ICMs). 
    • “The U.S. Food and Drug Administration (FDA) has classified the issue as a Class II recall. No patient injuries have been reported at this time. 
    • “According to Boston Scientific, no devices need to be returned or replaced. However, there are steps users can take to address the issue until it can be properly fixed.”
  • and
    • “Heartvue.ai, a medtech company based in Tennessee, has secured U.S. Food and Drug Administration (FDA) clearance for its new artificial intelligence (AI)-enabled imaging software that views, processes and evaluates cardiac MRI scans. Innolitics, an Austin-based consulting firm, helped guide Heartvue.ai through the regulatory process.
    • “The newly cleared software, Heartvue.Proton, uses advanced AI algorithms to automate measurements of 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification. Automating these measurements saves time, though each result is still reviewed and confirmed by a trained clinician. The software was designed to integrate with a hospital’s PACS or EHR system and slide right into any existing cardiology or radiology workflow.
    • “This clearance also includes a Predetermined Change Control Plan (PCCP), which helps Heartvue.ai make specific updates to this software without submitting additional requests to the FDA.”

From the public health and medical / Rx research front,

  • Per a CVS Health news release,
    • “CVS Health® (NYSE: CVS) today announced that updated 2026-2027 COVID-19 vaccines are now available at CVS Pharmacy® and MinuteClinic® locations for patients at no-cost with most insurance plans. Appointments are available at CVS.com, MinuteClinic.com and through the CVS Health® app, and walk-ins are accepted at CVS Pharmacy and MinuteClinic.
    • “We know patients value having convenient access to the vaccines and preventive care services they need,” said Amy Compton-Phillips, MD, Executive Vice President and Chief Medical Officer, CVS Health. “With updated COVID-19 vaccines available at CVS Pharmacy and MinuteClinic, we’re making it easier for people to get vaccinated close to home and on a schedule that works for them.”
    • “CVS Pharmacy offers COVID-19 vaccinations for eligible patients based on state regulations*, while MinuteClinic provides vaccinations for patients beginning at 18 months of age. Pharmacists and MinuteClinic providers are available to answer questions and help patients make informed decisions about vaccination based on their individual health needs.”
  • Nature reports,
    • “Just one week after the landmark US approval of a game-changing drug for advanced pancreatic cancer, the same therapy is showing promise against the world’s biggest cancer killer: lung cancer.
    • “In a small clinical trial of the drug daraxonrasib (Rasonque), tumours shrank in more than 30% of participants with the most common form of lung cancer, non-small-cell lung cancer. Each participant had a tumour-promoting mutation in a member of the RAS family of proteins, and had previously tried other therapies.
    • “We consider the results incredibly promising,” says Kathryn Arbour, a thoracic oncologist at the Memorial Sloan Kettering Cancer Center in New York City, and an author of the study, which was published on 2 September in the New England Journal of Medicine1. “These are exciting times.”
    • “A larger study in which participants with non-small-cell lung cancer are randomly assigned to receive either daraxonrasib or standard chemotherapy is under way. Regulators such as the US Food and Drug Administration (FDA) are likely to require results from that trial before approving the drug as a lung cancer treatment.”
  • Beckers Hospital Review interviews five health system leaders about their “plans to fast-track breakthrough pancreatic cancer drug.”
  • The New York Times relates,
    • “Can psilocybin, the hallucinogenic compound also known as magic mushrooms, inoculate cancer patients against the debilitating nerve damage caused by chemotherapy? At first blush, such an outcome might seem like wishful thinking.
    • “But a study published on Thursday in the journal Science makes a compelling case that administering psilocybin shortly before cancer treatments might prevent chemotherapy-induced peripheral neuropathy, a condition that affects about two-thirds of patients who receive chemo.
    • “The scientists studied mice, but the results are so promising that human trials are beginning this month. If successful, the treatment could revolutionize cancer therapy and improve the quality of life for millions.
    • “There are no effective treatments for neuropathy, which causes pain, tingling and numbness in the hands and feet, and can force patients to scale back or halt chemotherapy when the discomfort becomes too much to bear.” * * *
    • “Researchers said they did not yet know whether psilocybin could treat or reverse the symptoms of neuropathy in patients who already have it.
    • “If the results hold up in humans, the treatment could open a new chapter in the emerging field of psychedelic medicine, which until now has largely been focused on psychiatric conditions.”
  • Beckers Hospital Review considers whether medication safety is improving.
  • BioPharma Dive adds,
    • “A dual-acting cancer drug developed by China-based Akeso helped people with lung cancer live longer after treatment than did Merck & Co.’s blockbuster immunotherapy Keytruda, the company said Thursday, results that support an emerging body of evidence suggesting the medicine may become a future backbone of non-small cell lung cancer care.
    • “Akeso and its U.S.-based licensee Summit Therapeutics didn’t disclose full results, which came from a new data cut of the trial in Chinese enrollees with non-small cell lung cancer that first brought wide attention to “ivonescimab.” Full data is expected at a lung cancer conference later this month.
    • “The trial won’t be used as the main evidence to support U.S. approval, as the Food and Drug Administration will want to see outcomes from a global trial in this setting. Those are expected to come in 2028. It does, however, build confidence that a separate, all-important trial could show ivonescimab in combination with chemotherapy outperforms Keytruda and chemo.”
  • MedTech Dive notes,
    • “Ablation with Abbott’s dual-energy catheter, the TactiFlex Duo, was safe and effective in treating atrial fibrillation patients after one year, study results showed.
    • “The device combines pulsed field ablation, or PFA, and radiofrequency energy in one catheter to give physicians more flexibility in complex cases of AFib, an irregular heart rhythm that can lead to stroke or heart failure.
    • “Data from the FlexPulse IDE study, presented at the European Society of Cardiology Congress last week and published in the journal EP Europace, is the basis for Abbott’s Food and Drug Administration submission to market TactiFlex Duo in the U.S. The catheter received Europe’s CE mark earlier this year.” 
  • Cardivascular Business tells us,
    • “Xylitol, a sugar substitute often found in gum, baked goods and toothpaste, may significantly increase a person’s risk of dying or experiencing a heart attack or stroke, according to new data presented at the European Society of Cardiology (ESC) Congress 2026.
    • “The study’s authors noted that xylitol is a sugar alcohol that does occur naturally in the body in very low amounts. However, high levels of xylitol are also added to many sugar-free foods to help them taste sweeter, and the long-term cardiovascular implications of this trend have not been sufficiently explored. 
    • “The group reviewed data more than 17,000 participants in one of two datasets: the Canadian Longitudinal Study on Aging (CLSA) and the European Prospective Investigation into Cancer (EPIC)-Norfolk. According to CLSA data, the six-year risk of a major adverse cardiovascular event (MACE) was 57% higher among individuals who consumed the most xylitol than it was among those who consumed the least xylitol. According to EPIC-Norfolk data, the 30-year risk of a MACE was 18% higher among individuals who consumed the most xylitol than it was among those who consumed the least xylitol.” 
  • and
    • “Stroke patients should begin their road to recovery as soon as they are medically stable, according to a new guideline from the American Stroke Association (ASA) and American Heart Association (AHA). In fact, starting within the first 48 hours is recommended to maximize the patient’s chance of a full recovery.
    • “The new document, published in full in Stroke, highlights the importance of giving each patient a rehabilitation plan personalized to meet their own needs.[1] It is also critical that delays are kept to a minimum, and that specialists should start addressing physical, cognitive, communication and emotional concerns as quickly as possible.
    • “Each person faces a different set of challenges,” Lorie Gage Richards, PhD, an associate professor at the University of Utah and chair of the volunteer writing group behind this new guideline, said in a statement. “Recovery doesn’t look the same for everyone, and care should be personalized to fit each person’s needs. The goal is to help individuals gain as much independence as possible to perform everyday activities while improving their overall quality of life.”
    • “Sara Kutzle, who survived a stroke in 2021 at the age of 39 years old, helped craft the new guideline. She shared her perspective with the writing group, noting that it took a lot of hard work to feel like herself again.”
  • Health Day informs us,
    • “For community-dwelling older adults without clinical cardiovascular disease, atorvastatin is associated with a lower risk for major cardiovascular events, but does not improve disability-free survival, according to a study published online Aug. 28 in the New England Journal of Medicine to coincide with the annual meeting of the European Society of Cardiology, held from Aug. 28 to 31 in Munich.”
  • and
    • “Heart disease often starts decades before symptoms appear, and a major new study shows just how early.
    • “Currently, a person’s risk of developing atherosclerotic cardiovascular disease is estimated according to their risk factors, such as age, sex, smoking status, blood pressure and cholesterol levels, and this determines whether primary prevention strategies are prescribed,” said co-lead author Dr. Henning Bundgaard of Rigshospitalet-Copenhagen University Hospital in Denmark. 
    • “This approach relies on an estimation — not on knowledge of the presence of the actual disease (i.e., atherosclerotic plaques),” he said. “And we may be missing important opportunities to prevent cardiovascular events in individuals in whom atherosclerosis has built up many years previously.”
  • MedPage Today adds,
    • “Unruptured brain aneurysms were identified more frequently in recent years, a systematic review and meta-analysis showed.
    • “In studies of healthy people who had MR or CT angiography, the prevalence of an unruptured intracranial aneurysm rose from 2.9% to 6.6% over two decades, reported Nima Etminan, MD, of the University of Heidelberg in Mannheim, Germany, and co-authors.
    • “After adjusting for age and sex, the prevalence ratio was 1.8 (95% CI 1.1-2.8) for 2016-2022 compared with 2002-2015.
    • “The increase in unruptured aneurysms “is only in part explained by aging of the population and improvements in vascular imaging, which suggests that other, as yet unknown (e.g., environmental), risk factors play a role as well,” Etminan and colleagues wrote in Lancet Neurology.”
  • Genetic Engineering and Biotechnology News points out,
    • “A study by researchers at Harvard Medical School has shown that loss of function in the aldehyde dehydrogenase family 3 member B2 (ALDH3B2) gene can convert human pancreatic duct cells into functional β-like cells that can secrete insulin in response to glucose, and which lowered blood glucose levels when transplanted into diabetic mice. The team, headed by Peng Yi, PhD, an investigator at Joslin Diabetes Center, and assistant professor of medicine at Harvard Medical School, suggests that their results point to ALDH3B2 as a gene that could potentially be targeted in human pancreatic duct cells to replenish β cell mass for diabetes therapy.
    • “Senior and co-corresponding author Yi, together with first and co-corresponding author, Jian Li, a postdoctoral research fellow in the Yi lab at Joslin Diabetes Center and Harvard Medical School, reported on their findings in Science Translational Medicine, in a paper titled “Loss of function of ALDH3B2 transdifferentiates human pancreatic duct cells into β-like cells.”

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

  • Beckers Hospital Review reports,
    • “After a brief post-pandemic lull, hospital consolidation is accelerating again, with large health systems expanding across state lines, absorbing independent hospitals and reshaping regional care markets. 
    • “From portfolio resets and strategic exits to cross-market mergers and billion-dollar investments, these moves reflect how scale, capital access and geographic reach are becoming critical advantages in today’s healthcare landscape.
    • “[The article includes a non-exhaustive list of] 31 large health systems that have announced or plan to close strategic mergers, acquisitions or partnerships this year.”
  • Beckers ASC Review relates,
    • “A Brookings Institution analysis published Sept. 3 maps how deeply the five largest U.S. health insurers — covering 126 million Americans — have expanded into owning the physician practices, ASCs, pharmacies and PBMs they also pay for care through. Researchers used 2025 SEC filings, IRS Form 990s and state insurance-subsidiary schedules to trace the money.”
  • Fierce Healthcare tells us,
    • “West Virginia University Health System and Independence Health System’s have come to terms with Pennsylvania’s Attorney’s General Office on a planned acquisition that would bring the former organization to 30 hospitals.
    • “The settlement deal (PDF), filed in state court on Aug. 31 and shared Wednesday by the attorney general, includes terms requiring WVU Health System to keep the Independence hospitals and facilities open for at least five years, and to notify the office of any significant service changes. 
    • “WVU Health System also must install policies to block competitively sensitive information from flowing between its insurance and provider subsidiaries, maintain charity care and financial assistance policies and negotiate in good faith with payers, among other terms outlined in the agreement.”
  • Per Beckers Hospital Review,
    • “Salem (Ore.) Health Hospitals & Clinics completed its affiliation Sept. 1 with Stayton, Ore.-based Santiam Hospital and Clinics.
    • “The affiliation received approval in August from the Oregon Health Authority and Oregon Department of Justice. Both parties initially submitted the transaction for review in April through Oregon’s Health Care Market Oversight program, but withdrew the filing July 3, which ended the agency’s comprehensive review, and submitted a request for an emergency exemption that same day. 
    • “Under the affiliation, Santiam employees will become Salem Health staff, with Salem Health investing millions into improvements on healthcare infrastructure at Santiam Health, according to a news release.”
  • Modern Healthcare adds,
    • “Centene will exit California and Oregon commercial group markets next year.
    • “Nationwide, Centene serves nearly 500,000 enrollees through its commercial plans, representing less than 2% of its 25.9 million members.
    • “Centene has announced leadership changes, market exits in multiple states and voluntary employees buyouts as it navigates declining enrollment and federal funding cuts.”
  • Beckers Payer Issues informs us,
    • “Pharmacy benefit managers LucyRx and Abarca Health completed their strategic combination, according to an Aug. 20 news release.
    • “Across commercial and government markets, the PBMs serve more than 9 million members total. The companies now operate as wholly owned subsidiaries of Healthcare Revolution Partners. They still maintain their independent brands, leadership and client relationships.
    • “The combination unifies LucyRx’s employer focus and clinical capabilities with Abarca’s integrated claims and benefits platform, Darwin, and its knowledge of the government, regulatory, compliance and health plan landscape.”
  • Per Fierce Healthcare,
    • “Judi Health is expanding its list of clinical partners with the addition of Color Health, WellTheory and Cylinder.
    • “Each of these organizations targets a key area of focus for employers and plan sponsors and will be immediately available to Judi Health’s clients. Initially launching as pharmacy benefit manager Capital Rx about a decade ago, the company has invested in becoming an enterprise health solution that brings medical and pharmacy together.
    • “Other partners already in the Judi fold include Sword Health and Progyny, the company said in an announcement.
    • “Color Health operates the country’s first virtual cancer clinic with certification from the American Society of Clinical Oncology, and cancer care is the top condition driving healthcare costs for many employers. WellTheory, meanwhile, offers a solution for managing autoimmune and inflammatory conditions.”
  • and
    • “Telehealth platform GoodRx announced Thursday the launch of a companion family plan as part of its subscription service that offers free and low-cost prescriptions and savings on common healthcare services.
    • “GoodRx Companion Family Plan covers a primary member and up to four members, with no age restrictions and the inclusion of pets. The plan costs $24.99 per month or $16.99 for members paying annually. 
    • “Families don’t experience healthcare costs one person at a time,” said Wendy Barnes, president and CEO of GoodRx. “They’re simultaneously managing prescriptions and care for kids, parents, partners, and even pets. Expanding Companion across the entire household allows us to support consumers in a way that reflects this reality.”
    • “Barnes added that the new plan also advances the platform’s strategy to be a “more central part of how consumers navigate and pay for healthcare.”

Midweek report

David Ermer–CDC, Congress, FDA, NIH, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Beckers Hospital Review reports,
    • “In July, committees in the House and Senate advanced price transparency legislation that aims to expand disclosure requirements for hospitals, insurers and other healthcare providers.
    • “The Senate Committee on Health, Education, Labor and Pensions advanced the Patients Deserve Price Tags Act, which would implement new price transparency requirements for hospitals, insurers, laboratories, imaging providers and ASCs, while also expanding group health plans’ access to claims and reimbursement data held by insurers and PBMs.
    • “Starting in 2027, the bill would require hospitals to extend consumer-friendly price disclosures to every shoppable service they offer, eliminating the current cap that lets hospitals limit that disclosure to 300 services. A hospital CEO, CFO or similarly senior official would have to personally attest that pricing data is accurate — an attestation the bill treats as material to federal payment, which could raise False Claims Act exposure for errors. The bill would also eliminate online price-estimator tools as a standalone compliance option, add escalating daily penalties tied to bed count, and extend similar disclosure requirements to labs, imaging providers and hospital-affiliated ASCs by mid-2027. Providers would also be barred from pursuing collections when charges exceed a prior good-faith estimate, absent documented exceptions.
    • “The American Hospital Association opposed the bill, citing added administrative burden and objecting specifically to the removal of price-estimator tools as a compliance method and to a new ownership-disclosure requirement.
    • “Meanwhile, the House Energy and Commerce Committee advanced its own package, the Lower Costs, More Transparency Act. Starting in 2028, the bill would codify existing hospital shoppable-service and cash-price posting rules into law, require hospitals to publish facility identifiers and any ownership stake of 5% or more, and extend transparency mandates to freestanding ASCs, labs and imaging centers for the first time. It would also require insurers and group plans to publicly report prior authorization data — including denial rates, appeal-overturn rates and average decision times — and to disclose how premium dollars are split between claims, taxes and fees, and retained earnings, including at the Medicare Advantage plan level.
    • “The AHA said it supports giving patients clearer price information but warned that writing current requirements into law could limit CMS’ flexibility to refine them going forward.”
  • Beckers Payer Issues relates,
    • “Enacting site-neutral payments under Medicare for imaging services would generate an estimated $9.7 billion in combined savings over 10 years, according to a new analysis commissioned by the Blue Cross Blue Shield Association.
    • “The report, prepared by external consulting groups and published Aug. 24, quantifies both the Medicare impact and the spillover effects on commercial insurance markets. In July, CMS proposedin its 2027 hospital outpatient prospective payment system rule to extend site-neutral payment policies to imaging services without contrast (X-rays and MRIs for example) to off-campus hospital outpatient departments. Under the proposal, payments would be reduced from the full OPPS rate to the physician fee schedule equivalent rate, or an estimated 60% reduction.
    • “If finalized, the BCBSA analysis estimates $7.2 billion in total Medicare savings from 2027 to 2036, with $5.3 billion going to the federal government and $1.9 billion in reduced beneficiary out-of-pocket costs. CMS itself estimated $260 million in combined savings in 2027 alone, split between $190 million in government savings and $70 million in beneficiary savings.
    • “In the commercial market, the analysis estimates $2.5 billion in total commercial savings over the 10-year period, broken down as $1.6 billion in employer premium contributions, $530 million in enrollee premium contributions and $300 million in member out-of-pocket savings.”
  • Fierce Pharma informs us,
    • “RNA-based vaccines and therapeutics may have faced a bumpy road in the U.S. recently, but a major new federal investment proves the government is still betting big on its future.
    • “The Advanced Research Projects Agency for Health (ARPA-H) has narrowed down to five teams—a mix of biotechs and academic institutions—that will now receive up to $125 million in aggregate to help automate the production process for potential on-demand, personalized RNA-based medicines. 
    • “The new project falls under ARPA-H’s Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, which it says aims to build out automated production and real-time quality control through a distributed network. The idea, according to the agency, is to enable manufacturing of treatments near the patients they serve, rather than keeping genetic medicines sequestered around “major biomanufacturing hubs.
    • “Manufacturing expenses and the logistical headaches associated with the actual administration of genetic medicines—such as gene therapies—have proven to be a limiting factor for the field’s uptake in the real world.”  

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

  • Govexec reports,
    • “The Office of Personnel Management’s healthcare and insurance division, following recent staffing reductions, is getting new leadership ahead of its busy Open Season. 
    • “Matthew Kiley, a former Department of Health and Human Services official under the first Trump administration, will serve as the associate director of OPM’s healthcare and insurance division, starting Sept. 8, according to an internal memo obtained by Government Executive.
    • “A copy of Kiley’s resume shared with OPM employees and partially viewed by GovExec shows Kiley is the founder and former president of the Weyhill Group, a boutique management consulting firm in the greater Philadelphia area that serves clients in financial services, insurance and healthcare. 
    • “According to Kiley’s LinkedIn page, he also led the Office of Health Policy within HHS’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) between November 2019 and and January 2021.”
  •  Good luck, Mr. Kiley.
  • Federal News Network tells us,
    • “Agencies have a few months left to survey their employees before the required end-of-year deadline — and for most, it will be their first time distributing the Federal Employee Viewpoint Survey on their own.
    • “The change comes in the wake of the Office of Personnel Management’s proposal to decentralize the governmentwide employee engagement survey, which OPM has run for more than 20 years. Starting this year, however, OPM intends to leave the survey creation and distribution to individual agencies.
    • “Agencies have flexibility in determining the approach, timing and methodology that best meets their needs, provided their survey addresses all required elements,” OPM wrote in a July guidance document.
    • “For some federal workforce experts, moving FEVS to an agency-specific survey has been a welcome change. The opportunity for agencies to now add in questions tailored specifically to their own workforces is “exactly how it should be,” said Sydney Heimbrock, public sector chief industry advisor at Qualtrics.”

From the Food and Drug Administration front,

  • Pharmaceutical Technology reports,
    • “The US Food and Drug Administration (FDA) has continued its clampdown on the illegal trade of black-market peptides by issuing a string of warnings to online sellers, as non-approved drugs within this class generate a significant interest amongst the public on social media. 
    • “The five warning letters, which were issued to US-headquartered Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners and TXP Innovations LLC dba Tex Peptides, all detail violations in FDA regulations related to the sale of new peptide-based drugs, which remain unapproved and unregulated.  
    • “The FDA’s issues primarily centre around each company’s attempts to sell illicit weight loss products, with all five websites flagged in this crackdown advertising their own versions of Eli Lilly’s obesity candidate, retatrutide – a drug that is yet to secure approval within any global market. This comes a little after Lilly itself sounded the alarm on the drug’s burgeoning black market, which has begun to take off as some patients look to secure cheaper alternatives to branded weight loss medications.” 
  • BioPharma Dive relates,
    • “After a year of ups and downs, UniQure on Wednesday said it’s submitted applications for what could become the first medication approved to treat the underlying cause of Huntington’s disease.
    • “The Dutch company is asking the Food and Drug Administration to give its AMT-130 gene therapy a priority review, which could result in a decision in about eight months. UniQure said it’s also completed a submission with U.K. regulators.
    • “UniQure based its applications on previously announced three-year data that showed AMT-130 could significantly slow signs of disease progression. It’s asking the FDA for an “accelerated approval,” which means it would have to later supply research confirming the product’s clinical benefits.”

From the fraud, waste and abuse front,

  • Bloomberg Tax reports,
    • “The next phase of federal fraud enforcement is going to be data-driven. After using data mining and matching to uncover pandemic-relief fraud, the Justice Department and other agencies are expanding those tools to healthcare, foreign bribery, securities, consumer fraud, and public safety cases.
    • “This shift is significant and changes how investigations begin. The DOJ recently announced it is building the most sophisticated, innovative, and data-driven white-collar law enforcement component in the world, uniquely positioned to fight fraud at every level. This will include a cross-disciplinary team of experts in data science, and cutting-edge technology and resources.
    • “Rather than waiting for tips, audits, or referrals, the government will be using analytics, AI, cloud computing, and shared agency data to spot outliers and build cases earlier. For companies and individuals operating in data-rich regulatory environments, fraud risk may surface long before a subpoena arrives.”
  • The HHS Office of Inspector General tells us,
    • “CMS oversight of Medicare Part D sponsors did not prevent payments to pharmacies for some OTC drugs sold under obsolete Rx-only labeling.
    • “Part D sponsors made payments for five drugs associated with obsolete Rx-only labeling more than 1 year after the brand-name drugs were switched to OTC use. For calendar years (CYs) 2021 through 2023, Part D sponsors made $587.7 million in ineligible payments associated with the five drugs.
    • “The ineligible payments occurred because CMS: (1) updated its Part D Formulary Reference File using obsolete FDA data on Rx-only drugs and (2) did not set a timeframe for Part D sponsors to reject payments for OTC drugs sold under obsolete Rx-only labeling.
    • “Before we issued our draft report, FDA issued a policy in December 2025 requiring generic drug manufacturers to update their labeling “at the earliest time possible and within 6 months” after FDA approves an associated brand-name drug’s switch from Rx-only to OTC use.
    • “We recommend that CMS issue guidance on timeframes for Part D sponsors to reject payments for OTC drugs sold under obsolete Rx-only labeling after an Rx-to-OTC switch. This step could have helped to prevent $587.7 million in ineligible payments for CYs 2021 through 2023.
    • “CMS concurred with our recommendation.”

No Surprises Act News

  • Beckers Hospital Review reports,
    • “The House Ways and Means Committee is working on an overhaul of the No Surprises Act and a markup could happen in September, Punchbowl News reported Aug. 19. 
    • “Congress passed legislation creating the No Surprises Act in 2020, but critics say the law’s independent dispute resolution process has produced inflated reimbursement awards, raising concerns about rising healthcare costs. 
    • “The emerging proposal would combine Rep. Greg Murphy’s bill penalizing insurers that miss payment deadlines with new provisions aimed at curbing ineligible provider claims, according to the report. For revenue cycle teams, that’s a potential two-way street: faster insurer payment on IDR-eligible claims, but stricter eligibility standards before a claim can enter the process in the first place.
    • “The Senate HELP Committee is also planning a roundtable on the No Surprises Act this fall, according to the report.” 
  • Beckers ACS Review informs us,
    • “New federal data shows the independent dispute resolution process created under the No Surprises Act is being used more than ever. Total federal IDR disputes rose from 653,445 in Q3 of 2025 to 719,118 in Q4 of 2025 — a roughly 10% jump. 
    • “One state is driving an outsize share. According to CMS’ IDR Supplemental Tables for Q3 and Q4 2025, Texas generated more arbitration disputes than the next nine states combined.”
  • Modern Healthcare shares information about the federal IDR dispute arbitrators.
    • “Arbitrators rule for providers at varying rates. Some back providers as much as 98% of the time, while others approach an even split in the fourth quarter of 2025, according to Georgetown University research published in the journal Health Affairs Forefront last month.
    • “Island Peer Review Organization, Provider Resources, EdiPhy Advisors, MCMC Services and Maximus Federal Services side with providers more than 90% of the time, while Medical Evaluators of Texas and ProPeer Resources pick providers’ bids less than 60% of the time, according to an analysis of Centers for Medicare and Medicaid Services data from the second half of 2025 by Elevance Health Vice President of Health Economics Ariel Bayewitz. * * *
    • “The sway arbitrators hold underscores their significance and why the industry needs greater transparency, said Erin Duffy, managing director of the University of Southern California Schaeffer Institute for Public Policy and Government Service. “There’s so much opacity right now,” she said.” * * *
    • “Each time an arbitrator determines a dispute is eligible and then makes a ruling, it collects a fee. If providers and insurers cannot mutually agree on an arbitrator, one is randomly assigned. 
    • “Fee amounts are decided at an arbitrator’s discretion. Island Peer Review Organization, EdiPhy Advisors and Livanta charge the most, according to a Modern Healthcare analysis of CMS data.
    • “Since the federal system has seen millions of more disputes than expected, arbitrators have received exponentially larger payouts than anticipated.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “Professional organizations representing pediatricians, family physicians, obstetricians, and other medical professionals jointly released guidelines Wednesday for who should get vaccines aimed at staving off influenza, Covid-19, and respiratory syncytial virus, or RSV, this coming winter.
    • “The combined effort, undertaken in conjunction with the University of Minnesota’s Vaccine Integrity Project, has two goals: to help medical professionals guide their patients, and to help individuals plan to get the vaccinations that should help them either evade these ailments, or minimize their risks of severe illness if they do become infected.” * * *
    • “A spokesperson for the CDC confirmed Wednesday that this respiratory season, flu and Covid vaccines, as well as monoclonal antibodies given to babies to protect them against RSV, will continue to be provided under the federal government’s Vaccines for Children program, which supplies free vaccines for roughly half of the nation’s children.” * * *
    • “Papers outlining the rationale for the various vaccination recommendations were published Wednesday in the Journal of the American Medical Association, JAMA, and an interactive tool to help doctors and the public review the science behind the decisions will be posted on the Vaccine Integrity Project’s website.”
       
  • Beckers Clinical Leadership adds,
    • “The American Academy of Pediatrics reaffirmed its recommendation that young and high-risk children receive COVID-19 vaccines and expanded the list of high-risk children it advises to receive respiratory syncytial virus immunization for a second season.
    • “The recommendations, published Sept. 2, come amid upheaval among federal health officials. About three weeks ago, President Donald Trump directed HHS to assess a reduced immunization schedule for children.
    • “COVID-19 vaccines and the respiratory syncytial virus (RSV) products are expected to remain covered under private insurance and the Vaccines for Children program.”
  • and
    • “More parents are declining hepatitis B vaccination and vitamin K prophylaxis for infants, and female infants are less likely than males to receive either, according to a research letter published Aug. 31 in JAMA. 
    • “Researchers at Children’s Hospital of Philadelphia and University of Pennsylvania, also in Philadelphia, set out to determine whether a infant’s sex was associated with a parent’s acceptance of vitamin K prophylaxis and hepatitis B vaccines. 
    • “The retrospective study analyzed live births from January 2018 to December 2025 at three University of Pennsylvania hospitals. Across 93,163 infants, 777 — or 8.3 infants per 1,000 births — did not receive vitamin K prophylaxis. For all infants, the rate of vitamin K prophylaxis declines doubled between 2018 and 2025. 
    • “A larger number, 9,400, did not receive the hepatitis B vaccine, according to the study. The rate equals 100.9 infants per 1,000 births. Parental declines increased between 2018 and 2025. 
    • “Compared to infant males, infant females were less likely to receive either the vitamin K or hepatitis B vaccine, the researchers found.”
  • Yesterday, the CDC offered recommendations for seasonal flu vaccinations.
    • Because of legal uncertainties and inquiries, the CDC states the recommendations for seasonal influenza vaccination from the July 2025 immunization schedule remain in effect for the 2026-2027 influenza season.
  • Health Day tells us,
    • “Low T” is a trendy health topic, with aging men sold testosterone as a veritable Fountain of Youth.
    • “But too much testosterone can also pose a risk to heart health, a new evidence review says.
    • “Men with low testosterone or high testosterone levels both have a higher risk of atrial fibrillation, a heart health disorder that increases risk of stroke, researchers report in the Journal of the Endocrine Society.
    • “Both too little and too much testosterone appear to raise the risk of atrial fibrillation, through separate biological mechanisms, which means the dose and the target level matter,” said senior researcher Dr. Rajat Barua in a news release. He is a cardiologist at the Kansas City Veterans Affairs Medical Center in Kansas City, Missouri.”
  • and
    • “There’s been a shocking increase in the number of kids who’ve accidentally eaten recreational drugs left around by adults, a new study says.
    • “The rate of accidental ingestions of recreational drugs among children younger than age 6 increased by more than 3,300% between 2000 and 2024, researchers report in the journal BMC Public Health. 
    • “Weed accounted for 85% of these reported ingestions, with edibles representing about half of all ingestions, researchers found.
    • “The recreational drug ingestion rate among children younger than 6 years reported to United States poison centers increased substantially over the study period, with increases especially pronounced for edible marijuana and psilocybin products,” said senior researcher Dr. Gary Smith in a news release. He is director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.”
  • and
    • “Lower predicted prevalences of birth defects are seen in association with periconception parental vitamin B12 and postconception maternal red blood cell (RBC) folate, according to a study published online Sept. 1 in the Annals of Internal Medicine.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded study has shown that the GLP-1 drug semaglutide extended lifespan in older, healthy mice by tempering the detrimental effects of aging. Researchers at the University of California, Berkeley directly compared the effects of the treatment to those of reduced food intake. They found that the drug mimicked the anti-aging benefits of calorie restriction, conferring even greater benefits in some areas.
    • “While GLP-1s have been found to delay the onset of many age-related diseases in animals, this new study in healthy older mice offers evidence that these drugs may slow physiological aging itself, a notion that could potentially tie the widespread benefits of GLP-1s to a common source.
    • “Most chronic diseases are deeply rooted in the aging process. If GLP-1 agonists do indeed slow it down, then a wide range of clinical benefits is exactly what you’d expect to see,” said Rafael de Cabo, Ph.D., a senior investigator at the NIH’s National Institute on Aging (NIA), and author of a commentary on the new study.”
  • Beckers Hospital Review points out,
    • “More than a dozen experimental obesity drugs are working their way through clinical trials, and the last year has reshuffled the leaderboard: some candidates have advanced into pivotal phase 3 studies, others have won approval overseas and at least one program has been abandoned. 
    • “[The article includes] a status check on 13 of the most closely watched drugs.
  • MedPage Today notes,
    • “In a cohort study of men with nonmetastatic prostate cancer, the highest level of post-diagnosis saturated fat consumption was associated with greater all-cause mortality compared with the lowest level.
    • “This increased risk of all-cause mortality was likely due to deaths from cardiovascular disease.
    • “There was no association between consumption of dietary fats and prostate cancer mortality.”
  • Per STAT News
    • “The biotech company Ultragenyx said Wednesday that its experimental therapy for Angelman syndrome, a rare disease that causes severe intellectual disabilities and developmental delays, showed no benefit compared to a sham treatment in a large Phase 3 trial. 
    • “The drug, GTX-102, had shown powerful results in early trials, raising the hopes of families affected by the devastating condition. Many advocates for patients with other neurological conditions also hoped it could be the first of many medicines that improve cognition, communication, and other aspects of the lives of patients with intellectual disabilities.
    • “The news is a significant blow for Ultragenyx’s business as well. Although the company has multiple approved medicines, they are for mostly ultra-rare diseases, and investors had been banking on the Angelman drug as the company’s path to profitability.”

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

  • The New York Times reports,
    • Large and small employers are bracing for what looks to be the sharpest increase in health care costs in more than two decades. The cost per worker is projected to go up an average of 11 percent next year, or somewhat lower if workers’ insurance benefits are reduced, according to a U.S. survey released Wednesday.
    • “The employers’ final costs, after they make changes to health plans, are still expected to increase about 8 percent next year, the steepest since 2003, according to Marsh, the benefits consultant formerly known as Mercer.
    • “More than a third of the 1,800 employers surveyed said they anticipated that costs would rise at least 10 percent after making cuts.” * * *
    • “The Marsh survey is the latest report by an employer group or benefit consultant predicting a sharp rise in health care costs next year. Many Americans, even those with insurance, are already struggling to afford care, according to various surveys, and health care has become a top issue for voters.
    • “This seems to be a new normal,” said Ellen Kelsay, the chief executive of Business Group on Health, which represents large employers that offer health benefits.”
  • Beckers Hospital Review adds,
    • “Hospitals are seeing more self-pay patients as coverage losses mount across both the ACA and Medicaid markets.
    • “In a study published Aug. 31, Epic Research found self-pay visits are increasing across hospital settings as Medicaid enrollment has fallen across the country following the expiration of continuous enrollment protections in place during the pandemic. 
    • “Epic’s research looked at more than 550 million U.S. healthcare encounters between the first quarter of 2022 and the second quarter of 2026 and found that self-pay visits are increasing the most in emergency departments, climbing from 5.5% to 7.6% during the period. Across the same timeframe, self-pay inpatient admissions rose from 1.9% to 2.6%, births from 0.8% to 1.3% and primary care from 1.8% to 1.9%.”
  • and
    • “New Hyde Park, N.Y.-based Northwell Health recorded operating income of $76.1 million (1.4% margin) in the second quarter of 2026, down from $100.3 million (2% margin) in the same quarter last year, according to its Aug. 31 financial report.” 
  • Healthcare Dive relates,
    • “Johns Hopkins Health Plans is elevating its finance leader to interim CEO while the Baltimore-area managed care company looks for a permanent successor for its previous chief executive, who left to join a rival insurer last month.
    • “Placing Daniel Chojnowski in the interim position will provide stability as JHHP recruits for its next CEO, the insurer said in a Tuesday post on LinkedIn. James Holland, JHHP’s former chief executive, served in the role for seven years before leaving to lead Humana’s Medicaid division in August.
    • “Chojnowski “embodies the modern CFO, which has evolved from the number-crunching budget guard to a strategic partner, helping to steer organizational decisions,” JHHP said.”
  • Tech Target tells us,
    • “Since 1936, Nemours Children’s Health has provided pediatric healthcare, research and education to children and families. Today, Nemours has more than 70 specialty, primary and urgent care facilities in Delaware, Florida, Pennsylvania and New Jersey. It is reimagining how to deliver pediatric healthcare for better health outcomes, with the belief that nearly 80% of what affects a child’s health occurs in their home, school and community.
    • “As hospitals and healthcare organizations across the U.S. face rising costs, staffing pressures and demand for capacity, hospital-at-home programs are evolving into enterprise-scale distributed care models. That shift requires healthcare providers to coordinate remote monitoring, clinical workflows, escalation processes, scheduling and patient engagement across integrated technology platforms. Nemours Children’s approached Advanced Care at Home (ACaH) not as a standalone telehealth initiative, but as a coordinated care delivery model integrated into enterprise workflows, operational oversight and its existing Epic electronic health record (EHR) infrastructure.
    • “For Nemours, hospital-at-home became less of a telehealth service and more of a distributed operating model requiring centralized workflow coordination, operational accountability and enterprise-wide visibility.
    • “Through its ACaH program, Nemours Children’s extends certain pediatric care, monitoring and recovery services into patients’ homes through remote monitoring, virtual visits, care coordination and integrated clinical workflows.”
  • Fierce Healthcare informs us,
    • “Thyme Care landed a series E financing round of more than $125 million backed by strategic payers and providers as it aims to expand beyond cancer care navigation.
    • “The fresh financing will fuel the company’s continued growth and establish a new parent organization, Thyme Companies, that aims to build a broader portfolio of businesses to address broader cancer care challenges.
    • “JPMorgan’s Morgan Health led the series E round, with participation from strategic investors including Humana and CVS Health Ventures, valuing the oncology-focused company at more than $2 billion. Institutional investors AlleyCorp, HealthQuest Capital, Foresite Capital, Concord Health Partners, Frist Cressey Ventures, Town Hall Ventures and a16z Bio + Health also backed the round.”
  • Per MedTech Dive,
    • “Medtronic said it will invest about $700 million in a partnership with Cornerstone Robotics that includes rights to distribute the Hong Kong-based company’s soft tissue surgical robot in China, Singapore and Europe.
    • “Cornerstone developed its Sentire robotic system in-house and won Europe’s CE mark in May for its use in general surgery and gynecologic, thoracic and urologic procedures. The robot is also approved in China and Singapore.
    • “Distributing Cornerstone’s Sentire robot alongside Medtronic’s Hugo system will expand access to robotic surgery and give surgeons and health systems more choice, Medtronic said. “It’s a global play for us. It’s one of a number of investments we’re making in soft tissue,” Medtronic CEO Geoff Martha told investors on the company’s earnings call Tuesday.”
  • and
    • “Stryker said Monday it has agreed to acquire ZuriMED, a company making a device to treat rotator cuff tears. The companies did not share the terms of the deal.
    • “Zurich, Switzerland-based ZuriMED makes a system for rotator cuff augmentation, a procedure where a patch is applied to a torn rotator cuff to support healing and prevent the tissue from re-tearing. 
    • “Stryker expects the acquisition to strengthen its rotator cuff portfolio and support shoulder specialists in sports medicine and arthroplasty.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Monday report

David Ermer–Uncategorized–

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend update

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

Simplicity is a virtue.

From Washington, DC

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

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

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

From the public health and medical / Rx research front

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

From the U.S. healthcare business front,

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