Thursday report

Generative AI

Thursday report

David Ermer–CMS, Congress, FDA, Generative AI, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The U.S. government is hurtling toward a shutdown in a matter of days with no exit ramp in sight, as Republicans and Democrats latch onto starkly different positions and the White House threatens to lay off more federal workers.
    • “Republicans are seeking a seven-week extension in federal funding at current levels, and they have dismissed Democrats’ demands for hundreds of billions of dollars in healthcare spending. In a move to raise the political pressure, President Trump’s budget chief late Wednesday vowed to use any lapse in funding to make deeper cuts in the federal workforce, a threat Democrats rejected as blackmail.
    • “Democrats see the funding deadline as a rare opportunity to shape legislation, and the party’s base voters are desperate for elected representatives to show more fight after months of demoralizing political defeats. Republicans are loath to offer any concessions, putting both parties on a collision course ahead of the Oct. 1 deadline.
    • “Democrats have “asked us to do something that’s totally unreasonable,” President Trump told reporters on Thursday. Asked about the possibility of a shutdown, he said: “Could be. Because the Democrats are crazed. They don’t know what they are doing.”
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) has said he plans to stand firm this time and demand bipartisan talks, rather than acquiesce to a Republican plan to keep the government open, like he did in March. He said Democrats won’t be intimidated by the latest threat of federal layoffs.
    • “This is one of their threats, and their threats are not going to succeed,” Schumer said in an interview. “A lot of my colleagues who I’ve talked to today are very angry about this.”
  • Per Roll Call,
    • “Sources on both sides of the aisle and nonpartisan analysts agreed that, beyond the tough talk, top congressional Democrats have a weak hand to play and no discernible strategy for extracting the concessions from President Donald Trump and GOP leaders that they want on health care policy.
    • “A shutdown for the sake of a shutdown doesn’t help anyone,” a former Democratic congressional aide granted anonymity to speak candidly said. “If there is a shutdown, there also needs to be a plan to get out of it — and it will require a deal on all sides to end it, at a time when tensions would be even higher. It’s hard to turn back to bipartisan negotiations after that.”
  • Federal News Network adds,
    • “The Trump administration is taking a more aggressive approach than usual to what would happen in a government shutdown, after a White House memo Wednesday night told agencies to plan for further reductions in force if government funding lapses early next week.
    • “But with just days left before a government shutdown, many are questioning the ability for agencies to put together further RIF plans at all, since the reduction-in-force process is typically complicated and time-consuming, often taking months or longer.”
  • Bloomberg reports,
    • “The US will impose a 100% tariff on branded or patented pharmaceuticals, President Donald Trump announced Thursday.
    • “Starting October 1st, 2025, we will be imposing a 100% Tariff on any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America,” Trump said in a social media post.
    • “Trump said there would be no tariffs on pharmaceutical products if companies have broken ground on a US manufacturing plant, or if such a plant is under construction.”
  • and
    • “Pharmacy middlemen are working on a proposal to voluntarily change some of their business practices to avoid new regulation from the Trump administration.
    • “The proposals under discussion include ensuring patients don’t pay more than a pharmacy would charge to someone without insurance and increasing the use of lower-cost versions of expensive biologic drugs.
    • “The Pharmaceutical Care Management Association has drafted proposals to bring to the Centers for Medicare and Medicaid Services, according to a document viewed by Bloomberg News.”
  • The American Medical Association adds,
    • “The Department of Commerce Sept. 24 released a notice seeking public comment on an investigation it launched Sept. 2 on imports of personal protective equipment, medical consumables and medical equipment under Section 232 of the Trade Expansion Act of 1962. The provision authorizes the president to impose tariffs or other trade restrictions if an investigation determines that the importation of particular goods affects national security. The department is seeking comment on a range of criteria, including the current and projected demand for PPE, medical consumables and medical equipment; the extent to which production can meet demand; the role of foreign supply chains in meeting U.S. demand; the concentration of U.S. imports of those products and more. Comments are being accepted for 21 days following publication in the Sept. 26 Federal Register.”
  • Bloomberg tops it off with this,
    • “Three hours inland from Chennai, India, traffic crawls on a half-finished road past rice fields and cow crossings until it reaches a newer complex of neat white buildings. Among them is the cancer wing of a hospital founded over a century ago by American missionaries.
    • “By morning, the line of people waiting to be seen at Christian Medical College Vellore’s Ranipet Campus snakes from the parking lot to the front door. In a basement treatment room one day in May, several of those who’ve made it inside sit in beds getting an intravenous drip of a Bristol Myers Squibb Co. drug called Opdivo or a competing Merck & Co. drug, Keytruda. A single infusion might cost at least $7,000 at the standard dose in the US, and a year’s treatment more than $200,000. Here, by financial necessity, most of the patients are getting as little as one-sixth of that.  
    • “The remarkable thing is that the radically low doses may also be effective at keeping cancer sufferers alive, doctors here and in other hospitals across India say. The science isn’t settled, but hospitals in Israel, France, the Netherlands, Canada and the UK are all testing or implementing more modest dose reductions. A small trial in the US also found some benefits. The consequences could be dramatic, expanding access to cancer treatment in poor countries and bending the curve of skyrocketing drug prices in the developed world. Smaller doses could also help limit the serious side effects many patients endure, from diarrhea to thyroid problems.
    • “A broad reevaluation of dosing has the potential to benefit hundreds of thousands of people in developing countries who otherwise wouldn’t be able to afford the drugs. One obstacle has stood in the way: the drugmakers themselves. Paid per dose, they stand to lose billions of dollars if doctors prescribe less medicine to their patients.”
  • From ARPA-H news releases
    • The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new research and development opportunity through its Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE) program. THRIVE intends to develop integrated platform technologies to accelerate precision genetic medicines (PGMs) and provide single-intervention precision treatments to slow, reverse, or prevent diseases at the genetic level. The program is designed to optimize affordability, scalability, and sustainability of lifesaving PGMs for patients through existing regional treatment centers and virtual clinics. This will allow patients to be seen and treated where they live.” * * *
    • “Learn more about THRIVE on its program page, including information about the solicitation and Proposers’ Day.” 
  • and
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new funding opportunity through its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. With cutting-edge production technologies, the program seeks to establish the U.S. as a frontrunner in advanced manufacturing methods for high-quality genetic medicines.” * * *
    • “Learn more about GIVE on its program page, including information about the ISO solicitation and Proposers’ Day registration.”
  • Per a U.S. Office of Personnel Management news release,
    • The U.S. Office of Personnel Management (OPM) today announced record levels of engagement and leadership from the Chief Human Capital Officers Council (CHCOC) under the Trump Administration, underscoring the Council’s critical role in driving forward personnel policy and workforce reform across the federal government. The Chief Human Capital Officers Council is the principal interagency forum for federal human capital leaders, bringing together the Chief Human Capital Officers from across the Executive Branch to coordinate policy, share best practices, and advance government-wide workforce initiatives.
    • Since January of this year, the Council has held 71 sessions, an increase of almost double compared to the 40 sessions held last year. These sessions cover everything from discussing the Deferred Resignation Program and return-to-office policies to SES performance and collective bargaining. Between January and March alone, the Council convened 34 times in just 50 workdays. Alongside these sessions, the Council has distributed more than 200 communications to federal agencies this fiscal year, including official memos, weekly updates, and special notices.
  • OPM also recently posted Benefits Administration Letter 25-102 about FEHB Enrollment Coordination for Married Federal Employees and Annuitants.
  • Avalere Health discusses an upcoming meeting at which new ICD-10 codes for 2026 will be selected.

From the Food and Drug Administration front,

  • BioPharma Dive relates,
    • “Capricor Therapeutics executives came out of a meeting with Food and Drug Administration officials confident that they can reverse a rejection of their experimental cell therapy for Duchenne muscular dystrophy. 
    • “The FDA turned down Capricor’s application for the drug, deramiocel, in July after questioning the research supporting its effectiveness. At the time, Capricor CEO Linda Marbán said the rejection was a surprise and that no major issues had been raised during the review.
    • “Now, FDA officials are indicating that they will reconsider the application with new data from a clinical trial called Hope-3 that’s already been completed, Capricor said Thursday. That’s important because Capricor won’t have to start all over with a new submission. “This is a giant win for us,” Marbán said during a conference call with analysts. Initial trial results are expected in the middle of the fourth quarter.”
  • and
    • “The Food and Drug Administration on Thursday approved a new medicine for breast cancer, clearing Eli Lilly’s Inluriyo for people with a specific genetic mutation.
    • “Previously known as imlunestrant, the drug has been cleared for use in a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one hormone therapy. The approval makes the treatment available specifically to people who fit that criteria and have mutations to a gene called ESR1 — an alteration Lilly believes to occur in about half of people with that form of the disease either during, or after, exposure to hormone therapy.
    • “The clearance was based on results published in the New England Journal of Medicine last year. Those findings, from a study called EMBER-3, showed that Inluriyo helped reduced the risk of disease progression or death among those with ESR1 mutations by 38% when compared to standard hormone-suppressing therapies. Inluriyo delayed tumor progression by a median of 5.5 months, or close to 2 months longer than those on typical drugs.”  
  • and
    • “Heartflow has received 510(k) clearance for an updated version of its plaque analysis algorithm, the company said Monday.
    • “The updated algorithm shows a 21% improvement in plaque detection, compared to the original version of the technology, the company said. 
    • “Heartflow disclosed the clearance alongside news that Cigna has become the second national insurer after UnitedHealthcare to update its policies to cover the plaque analysis product.”
  • MedPage Today points out,
    • “A risk evaluation and mitigation strategies (REMS) program is no longer required for the thyroid cancer therapy vandetanib (Caprelsa), the FDA announced on Thursday.
    • “The agency had required the safety program for vandetanib to ensure appropriate heart rhythm monitoring and safe use since its approval in 2011opens in a new tab or window as treatment for medullary thyroid cancer in patients whose disease has spread or cannot be surgically removed.
    • The approval of vandetanib was based on results from the phase III randomized ZETA trial in which patients randomized to receive vandetanib experienced a 65% reduction in the risk of disease progression compared to patients on placebo. A REMS was required for vandetanib due to potential for QT prolongation and reported cases of torsades de pointes and sudden death in patients taking the drug.
  • Fierce Pharma informs us,
    • “After nearly two decades in the endocrine scene, Crinetics is making its commercial debut with the approval of a game-changing treatment for the rare growth disorder acromegaly.
    • “The FDA on Thursday signed off on Crinetics’ paltusotine—now christened Palsonify—as a first-line treatment for adults with acromegaly for whom surgery didn’t work or isn’t an option.
    • “The drug is a selectively targeted somatostatin receptor type 2 (SST2) agonist. Unlike other somatostatin drugs that make up the bulk of current acromegaly care options, Palsonify is a small molecule, non-peptide therapy that can be taken orally, freeing up patients from frequent and often painful injections.
    • “The treatment marks the “next level of care for patients with acromegaly,” Scott Struthers, Ph.D., co-founder and CEO of Crinetics, said in a recent interview with Fierce Pharma, staking that claim on the drug’s ability to both help control patients’ hormone levels and address their symptoms in a once-daily treatment option.”
  • Per FDA news release,
    • “Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow the progression of the disease in children 6 to 12 years old at the initiation of treatment.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal court has tossed a rule outlining how auditors must review Medicare Advantage insurance companies for overpayments, adding uncertainty to the federal government’s plan to audit every plan annually.
    • “On Thursday, Judge Reed O’Connor, of the U.S. District Court for the Northern District of Texas in Fort Worth, vacated the 2023 Medicare Risk Adjustment Data Validation, or RADV, rule, on the grounds that regulators violated the Administrative Procedure Act of 1946.”
    • “Under the rule, which was finalized in January 2023, the Centers for Medicare and Medicaid Services eliminated a key statistical tool, the fee-for-service adjuster, used to compare error rates in traditional Medicare versus Medicare Advantage. Regulators planned to apply the new audit method retroactively to insurers’ risk-adjustment code reviews dating back to 2018. When the rule was finalized, CMS estimated that the more stringent reviews would result in insurers returning $4.7 billion to the agency between 2023 and 2032. 
    • “Humana sued over the rule in September 2023, alleging the new audit methodology held private Medicare insurers to a higher standard than the fee-for-service program. 
    • “O’Connor sided with the insurer.  In a Thursday order, he ruled that CMS failed to adequately notify the industry that actuarial equivalence between traditional and Medicare Advantage plans no longer applied.
    • “Because there was no meaningful notice of defendants’ ultimate finding that actuarial equivalence does not apply to RADV audits, there was no meaningful dialogue regarding the costs and benefits of the surprise changes,” O’Connor wrote in the order.” 

From the public health and medical / Rx research front,

  • MedPage Today lets us know,
    • “Women who missed their first screening mammogram had a 53% higher risk of stage III breast cancer over the next 25 years and almost a fourfold higher risk of stage IV breast cancer.
    • “Breast cancer mortality was 40% higher among screening nonparticipants.
    • “Breast cancer incidence was nearly identical, suggesting the increased risk of later-stage diagnosis and breast cancer mortality resulted from delayed detection.”
  • Per Health Day,
    • “During August 2021 to August 2023, only 36.4 percent of U.S. adults had no cardiovascular disease (CVD) risk factors, according to a September data brief published by the National Center for Health Statistics.
    • “Catharine A. Couch, Ph.D., R.D., from the National Center for Health Statistics in Baltimore, and colleagues presented prevalence estimates for none, one, or two or more CVD risk factors (uncontrolled high blood pressure, uncontrolled high blood lipids, uncontrolled high mean blood glucose, and high body mass index) in U.S. adults from August 2021 to August 2023.
    • “The researchers found that 36.4, 34.9, and 28.7 percent of U.S. adults had no, one, and two or more CVD risk factors, respectively. More men than women had two or more CVD risk factors (31.7 versus 25.8 percent). With age, there was a decrease in the percentage of adults with no CVD risk factors, while a higher percentage of older adults had one or two or more CVD risk factors. Those with family income 350 percent or more of the federal poverty level had the highest percentage of adults with no CVD risk factors and the lowest percentage with two or more CVD risk factors. The percentage of adults with two or more CVD risk factors increased from 2013 to 2014 to August 2021 to August 2023.”
  • and
    • “Physical frailty may contribute to the development of dementia, according to a study published online Sept. 17 in Neurology.
    • “Xiangying Suo, from the School of Public Health of Zhengzhou University in China, and colleagues conducted a prospective cohort study based on U.K. Biobank participants without dementia to examine the link between physical frailty and dementia. Five criteria were used to define physical frailty (weight loss, exhaustion, physical inactivity, slow walking speed, and low grip strength).
    • “A total of 8,900 dementia cases were documented during a median follow-up of 13.58 years among 489,573 participants. The researchers found that the risk for dementia was significantly higher in those with prefrailty and frailty compared with nonfrail individuals (hazard ratios, 1.50 and 2.82, respectively). Compared with those with low genetic risk and nonfrailty, the highest risk for dementia was seen for participants with frailty and high genetic risk (hazard ratio, 3.87 for high polygenic risk score; 8.45 for APOE-ε carriers). A potential causal relationship was seen between physical frailty and dementia in the forward Mendelian randomization (MR) analysis (odds ratio, 1.79), while a null causal association was suggested in the reverse MR. Potential underlying mechanisms linking physical frailty to dementia include genetic background and neurologic and immunometabolic function.”
  • BioPharma Dive considers “Cancer patients are living longer than ever. Pain drugmakers haven’t kept up. Decades of slow-moving research, along with broader failures of the healthcare system, have left millions of people in daily pain. Doctors fear that’s bound to continue.”
  • BioPharma Dive also notes,
    • “Eli Lilly has canceled one clinical trial of an experimental muscle-sparing obesity drug, citing “strategic business reasons,” according to a federal database. The study was one of two Phase 2 trials testing the drug, known as bimagrumab, alone or with Lilly’s marketed medicine in people with obesity. The now-halted study included Type 2 diabetics as well.
    • “In an email to BioPharma Dive, a Lilly spokesperson said company executives “routinely evaluate our clinical development programs to optimize the potential for each product” and noted that a separate trial involving non-diabetic people with obesity is still underway. The trial stoppage was first reported by Bloomberg.
    • “Bimagrumab is among the drugs designed to preserve muscle in people taking weight loss drugs like Zepbound and Novo Nordisk’s Wegovy, which can cut lean mass as well as fat. But at least one biotech has said that additive weight loss effects are an approval requirement, suggesting higher clearance standards have been established by the Food and Drug Administration.”
  • The Washington Post explains why the brain hangs on to some memories but allows others to fade. Tying “fragile” memories to emotional events could help people remember them better in the future, researchers at Boston University believe.”
  • Per a National Institutes of Health news release,
    • “Today, the National Institutes of Health (NIH) announced the award of contracts for launching the Standardized Organoid Modeling (SOM) Center, a national resource that will be dedicated to using cutting-edge technologies to develop standardized organoid-based new approach methodologies (NAMs) that deliver robust, reproducible, and patient-centered research findings. With contracts totaling $87 million for the first three years, the center will be housed at the Frederick National Laboratory for Cancer Research (FNLCR), a facility supported by NIH’s National Cancer Institute (NCI). The center’s goal will be to leverage the latest technologies to enable real-time optimization of organoid protocols.
    • “This groundbreaking initiative will transform how we conduct biomedical research through innovative approaches to advancing human-based technologies,” said NIH Director Dr. Jay Bhattacharya. “By creating standardized, reproduceable, and accessible organoid models, we will accelerate drug discovery and translational science, offering more precise tools for disease modeling, public health protection, and reducing reliance on animal models.”

From the AI front,

  • STAT New reports,
    • “Artificial intelligence may help radiologists spot disease, but throwing the technology at millions of CT scans or mammograms is not without risks to patients and may drive up costs without showing much benefit. Katie Palmer reports on two efforts to prove out the potential.
    • “A large randomized controlled trial will explore the value of AI-aided mammography in screening for breast cancer. The technology is already widely used in the U.S., but the best evidence that it’s useful comes from Europe. The $16 million trial is funded by the Patient-Centered Outcomes Research Institute. Read more on what researchers may find here.
    • “Next month, NYU Langone Health will begin checking bone density in CT scans of people over 65 for osteoporosis, a condition that often goes undetected until someone breaks a bone. The health system may expand the work if it’s proven to help. This kind of opportunistic screening, which repurposes otherwise acquired scans, could be used to identify many treatable conditions. Katie’s interview is worth a read.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health closed another fiscal year with operations in the red, with the large Catholic nonprofit pointing to expenses growth outpacing revenues “despite strong volume, salary cost management and higher productivity.”
    • “The 138-hospital system reported an as-recorded operating loss of $687 million (-1.8% operating margin) for the fiscal year ended June 30, 2025, as compared to the prior year’s $581 million operating loss (-1.5% operating margin).
    • “However, after adjustments to normalize delayed income from the California Provider Fee Program, CommonSpirit somewhat improved its stature with a $225 million operating loss (-0.6% adjusted operating margin) as opposed to fiscal 2024’s $875 million operating loss (-2.4% adjusted operating margin).
    • “Net income in fiscal 2025 was $1.1 billion as recorded and nearly $1.6 billion as adjusted, both increases over the prior year’s respective $797 million and $503 million.”
  • and
    • “Value-based cancer care navigation company Thyme Care raised $97 million in series D funding backed by major strategic investors across payers, employers, health systems and retail health.
    • “The latest funding propels Thyme Care’s valuation to north of $1 billion, a 2x increase from its valuation in July 2024 when it raised $95 million, according to a company spokesperson.
    • “The company plans to use the new funding to expand its business across verticals and to take on more breaking points in the oncology journey that drive up costs and cause friction in the patient experience, Robin Shah, CEO and co-founder of Thyme Care, told Fierce Healthcare.
    • “Thyme Care is now focused on tackling treatment denials, high drug costs and “the barriers that delay or prevent access to timely, affordable and appropriate care,” Shah said.’
  • and
    • “Medicare Advantage (MA) has been a consistent earnings booster for insurers, but recent challenges in this space are likely to ding profitability, according to a new report.
    • “Analysts at AM Best found that elevated utilization trends beginning in 2023 led to a $5.7 billion underwriting loss in 2024 for MA plans, while insurers reported gains in the previous five years. Underwriting gains in MA accounted for 40% of total gains from 2019 to 2022, but that dropped to 20% in 2023.
    • “The report found that close to three-quarters of companies with a significant concentration in MA reported underwriting losses in 2024.
    • “Medicare Advantage enrollment and premium continue to grow as more people are aging into the program. However, plans have experienced an increase in utilization and medical trends that have persisted longer than expected,” said Jason Hopper, associate director for industry research and analysis at AM Best, in a press release.“
    • “Changes to the risk-adjustment payment model by the Centers for Medicare and Medicaid Services, as well as lower Star Ratings across the industry, also have contributed to recent underwriting losses,” Hopper said.
  • MedTech Dive informs us,
    • “Guardant Health and Quest Diagnostics will collaborate to offer Guardant’s Shield blood-based colorectal cancer test through Quest’s distribution network, the companies said Wednesday.
    • “Physicians will be able to order the test through their Quest accounts and electronic health record starting in the first quarter of 2026.
    • “In an investor day presentation, Guardant Co-CEO AmirAli Talasaz also revealed plans to expand Shield to include multi-cancer detection. The multi-cancer offering will be available nationally in October.”
  • Modern Healthcare reports,
    • “As more upstarts strive to make a splash in the pharmacy benefit manager sector, RxBenefits CEO Robert Gamble thinks his company has devised something truly novel.
    • “Like other companies seeking to disrupt a market dominated by CVS Health subsidiary CVS Caremark, UnitedHealth Group division Optum Rx and Cigna unit Express Scripts, Illuminate Rx promises pharmacy benefits without spread pricing or hidden fees, and with transparency and a focus on generic and biosimilar drugs. The company launched Illuminate Rx this month.
    • “What Gamble said differentiates this offering is that RxBenefits has added an in-house PBM to its marketplace platform, where self-funded employers, brokers and benefits consultants can select among Illuminate Rx and other PBMs for the best deals.”
    • “RxBenefits, which serves 3 million insurance members and manages $3 billion in annual pharmacy spending, named veteran executive Gamble as CEO last December following Wendy Barnes’ departure to become president and chief executive of the pharmaceutical discount vendor GoodRx.”

Tuesday report

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “President Donald Trump abruptly canceled his meeting with top Democratic leaders that had been planned for Thursday to search for a deal that might avert a partial government shutdown next week.”
  • The American Hospital Association News tells us,
    • ‘The Department of Homeland Security today released a proposed rule to amend the process for selecting among prospective applicants — known as registrants — for H-1B visas that are subject to statutory numerical caps. The rule would change the agency’s current process of conducting random selections to a weighted selection process. Weighted selections would be based on an individual’s wage level, with higher wage levels weighted more heavily. The rule would also apply the process to registrations subject to the regular cap and to those asserting eligibility for the H-1B advanced degree exemption. The proposal would require the use of additional wage level information, including the Occupational Employment and Wage Statistics wage level, Standard Occupational Classification code and the area of intended employment.”
  • and
    • “The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following reports of device components detaching during procedures. The company was alerted to incidents resulting in one patient death and one injury. The product is designed to be used with ultrasound endoscopes for lung cancer biopsies. In response to the reports, Olympus has implemented an automated inspection procedure during assembly to help improve the detection of device damage, which is a step that was previously done through a visual inspection. The FDA said health care personnel treating patients with the product must ensure it is not from an affected lot.”
  • Milliman delves into why “many Medicare beneficiaries will spend less than expected to reach the IRA’s new $2,000 out-of-pocket spending limit.”
    • “Among other changes to the standard Part D benefit design, the IRA introduces a hard MOOP—once the beneficiary attains $2,000 in TrOOP costs in 2025, they are no longer responsible for any cost sharing—aligning the TrOOP more closely with the typical definition of a MOOP.5 Another important change introduced by the IRA is that cost sharing for basic Part D coverage counts toward the MOOP, even if that basic coverage is reduced by certain other payers.6 Federal regulators refer to the amount of drug cost that accumulates (or counts) toward the MOOP in Part D as “TrOOP eligible cost.”7 For enhanced plans,8 TrOOP eligible cost is based on the greater of defined standard benefit cost sharing and the actual patient out-of-pocket (including any cost-sharing subsidies), such that actual patient out-of-pocket will never be higher than TrOOP eligible costs.9 This regulatory guidance has been referred to as the “greater of” logic.
    • “This “greater of” provision is impactful because the defined standard benefit is frequently leaner (i.e., has higher cost sharing) than the benefit a beneficiary may actually have. In fact, around 90% of non-low-income (unsubsidized) beneficiaries are enrolled in plans with enhanced benefits.10 Enhanced plans generally offer fixed copays on generic tiers, either coinsurance or copays on brand tiers, and coinsurance on specialty tiers. Plans are considered “enhanced” if they are meaningfully richer than the defined standard benefit. Other plans are considered “basic” and are roughly equivalent in richness to the defined standard benefit.11
    • “The IRA’s accumulation logic means many beneficiaries who satisfy their MOOP will do so without spending $2,000 out-of-pocket—i.e., their specific MOOP will be less than their $2,000 limit in TrOOP eligible costs. Assuming enhanced benefits similar to 2024, we expect roughly half of non-low-income beneficiaries who reach MOOP will spend less than $1,200 out-of-pocket in 2025.12
    • “Most likely, the only beneficiaries who will pay the full $2,000 to satisfy their MOOPs in 2025 will be non-low-income beneficiaries who are enrolled in a plan with basic Part D coverage13 or who are in an enhanced plan but exclusively utilize drugs with cost sharing greater than or equal to what is under (i.e., leaner than) the defined standard benefit. The most common instance of the latter occurs for specialty drugs on tier 5, which are almost always subject to a coinsurance greater than or equal to the defined standard coinsurance amount. In some cases, this could also occur for non-preferred brand (tier 4) drugs, where the plan offers a coinsurance benefit (typically 40% to 50%, compared to the defined standard 25%).”
  • The HHS Inspector General released a report
    • “Congress appropriated $178 billion to HHS to provide funds to eligible providers for health care-related expenses or lost revenue attributable to COVID-19 under the Provider Relief Fund (PRF) program. HHS was responsible for initial PRF program oversight and policy decisions, and HRSA administered the PRF program.
    • “Under the PRF terms and conditions, if a patient had health insurance and sought COVID-19 treatment from an out-of-network provider that received PRF payments, the provider would not seek to collect out-of-pocket payments greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider. (We refer to this as the “balance billing requirement.”)
    • “This audit assessed whether selected hospitals that received PRF payments complied with the balance billing requirement for COVID-19 inpatients.
    • “Of the 25 selected hospitals, 17 billed patients an amount that did not comply or may not have complied with the balance billing requirement. For example, one hospital billed a patient $6,000 when the patient’s insurance carrier had waived all patient cost-sharing responsibility.
    • “Hospitals stated that they were uncertain how to comply with the requirement because HRSA did not provide sufficient guidance. If HRSA developed and provided early and detailed guidance, hospitals might not have improperly billed selected patients a total of $637,035 for services provided.”
  • Per a Justice Department news release,
    • “The Justice Department’s Criminal Division today announced the expansion of its Health Care Fraud Unit’s New England Strike Force to the District of Massachusetts. This expansion brings enhanced federal enforcement resources to one of the nation’s most significant health care and life sciences hubs.
    • “The U.S. Attorney’s Office for the District of Massachusetts has a national reputation in health care enforcement and has developed a significant record of success in investigating and prosecuting health care fraud, including complex cases involving pharmaceutical and medical device companies, providers, and executives. In FY 2025 alone, working together on health care fraud enforcement, the U.S. Attorney’s Office’s Health Care Fraud Unit and Affirmative Civil Enforcement Unit recovered more than $450 million in fraudulently obtained funds. Building on the U.S. Attorney’s Office’s historic track record and the success of the Criminal Division’s Health Care Fraud Unit’s specialized prosecutors and data-driven, multi-agency Strike Force model, the Department is deploying a powerful force multiplier, allowing it to accelerate the detection, investigation, and prosecution of complex fraud schemes throughout the District of Massachusetts.”

From the public health and medical/Rx research front,

  • NBC News reports,
    • “One of the largest measles outbreaks in the U.S. is now centered in bordering areas of southwestern Utah and Arizona. 
    • “In Southwest Utah, all but one of the 23 confirmed cases are among unvaccinated, school-age kids, the Southwest Utah Public Health Department reported. In Mohave County, Arizona, which health officials believe is connected to the Utah outbreak, there have been 42 confirmed cases of the highly contagious virus.
    • “An NBC News investigation, done in collaboration with Stanford University, has found that much of the United States doesn’t have the vaccine protection to prevent outbreaks of communicable diseases such as measles.”
  • Cardiovascular Business informs us,
    • “Approximately 6.7 million Americans over the age of 20 have heart failure, according to a new data-driven analysis published by the Heart Failure Society of America (HFSA). That number is expected to rise, the group added and could hit approximately 11.4 million by 2050.
    • “Those were just some of the eye-opening statistics included in a new HFSA report published in the Journal of Cardiac Failure.[1] In addition, the group wrote, approximately one in four Americans will develop HF in their lifetime. And the odds are even greater for Black individuals than those from other racial and ethnic groups.”
  • The Washington Post points out what researchers suspect may be fueling cancer among millenials.
  • Genetic Engineering and Biotechnology News notes,
    • “Neurological disorders, such as schizophrenia and bipolar disorder, remain challenging to diagnose due to the absence of objective biomarkers. Current assessments largely rely on subjective clinical evaluations. 
    • “In a new study published in APL Bioengineering titled, “Machine Learning-Enabled Detection of Electrophysiological Signatures in iPSC-Derived Models of Schizophrenia and Bipolar Disorder,” researchers from Johns Hopkins University (JHU) present a computational analysis pipeline designed to identify disease-specific electrophysiological signatures from patient-derived cerebral organoids and two-dimensional cortical interneuron cultures. The findings may help reduce human error when diagnosing mental health disorders that currently only rely on clinical judgement.”
  • Health Day lets us know,
    • “Tattoos might protect against melanoma
    • “People with more tattoos were less likely to develop melanoma
    • “They might take better care of their skin, or the tats might provide some sort of screen from UV rays, researchers say.”
  • Per the American Journal of Managed Care,
    • “Colorectal cancer (CRC) screening rates remain lower in rural areas compared with urban communities, according to a new analysis of more than 535,000 adults in the US. Although education, income, insurance coverage, and provider access explain part of the disparity, more than 70% of the gap remains unaccounted for, pointing to deeper structural and cultural barriers that require equity-focused interventions.
    • ‘This analysis is published in Cancer Causes & Control.“
  • Per Fierce Pharma,
    • “Moderna has early in-human data showing its next-generation COVID-19 vaccine, mNEXSPIKE, has the potential to offer strong immune protection against the latest rapidly spreading SARS-CoV-2 virus.
    • “Moderna’s updated mNEXSPIKE vaccine showed an average greater-than-16-fold increase in neutralizing antibodies against the LP.8.1 sublineage in individuals 12 years of age or older, the company said Tuesday. The result comes from a postmarketing clinical study of the latest 2025-26 formula of mNEXSPIKE, which is designed to target LP.8.1.
    • “By comparison, the company’s first-generation mRNA vaccine, Spikevax, generated a greater-than-eightfold increase in LP.8.1-neutralizing antibodies across the same age groups, Moderna said.”
  • Per BioPharma Dive,
    • “A drug combination involving Bristol Myers Squibb’s experimental medicine iberdomide met one of its main goals in a Phase 3 clinical trial, helping to eliminate signs of multiple myeloma in significantly more enrollees than a standard regimen, the company said Tuesday.
    • “The data are from an interim analysis of a study that will continue so trial investigators can measure other goals like an impact on disease progression and survival. Bristol Myers will submit the results to health regulators, although executives have previously said an approval would probably only come if iberdomide meets its other objectives.
    • “Iberdomide is one of three protein-degrading drugs Bristol Myers is positioning as successors to blockbuster blood cancer drugs like Revlimid and Pomalyst, which it acquired through its merger with Celgene. Many of the products in its large portfolio of cancer drugs have either plateaued or are in decline.”
  • Per Medscape,
    • “A compound comprising five agonists that together tackle weight loss, glucose reduction, insulin sensitization, and blood fat normalization has shown promise in mouse models of obesity.
    • “The compound under investigation is called a quintuple agonist because, together with GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, it contains lanifibranor, a molecule that activates three different peroxisome proliferator-activated receptors (PPARs) — the alpha, delta, and gamma variants — all of which are involved in energy regulation.
    • “Notably, this is not a combination therapy — the five agonists are included in a single molecule.
    • “Daniela Liskiewicz, PhD, Institute for Diabetes and Obesity, Helmholtz Zentrum München, Neuherberg, and the German Center for Diabetes Research, both in Munich, Germany, discussed the development of the novel agonist at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.”
  • Here’s a link to the National Institutes of Health’s Research Matters newsletter.
  • Beckers Hospital Review identifies “six new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • Per MedTech Dive,
    • “Multi-cancer blood tests, with the promise of detecting many cancer types from a single sample, have the potential to transform cancer screening.
    • “However, evidence is lacking to support broad use of the tests in people who do not have symptoms, according to research commissioned by the Agency for Healthcare Research and Quality and published last week in Annals of Internal Medicine.
    • “Researchers identified no completed, controlled studies reporting benefits in cancer detection, mortality or quality of life from screening with multi-cancer detection tests. They also found insufficient evidence on the accuracy and potential harm of the tests, mostly due to study limitations and unknown or inconsistent findings.
    • “Researchers from the RTI International – University of North Carolina Evidence-based Practice Center and The Ohio State University College of Medicine conducted the review.”

From the AI front,

  • The Wall Street Journal relates,
    • “AI models are being designed to predict a woman’s near-future risk of breast cancer using mammograms.
    • “Clairity’s AI model received FDA authorization and can predict a woman’s five-year breast-cancer risk.
    • “AI models outperform older risk-score calculators, but some doctors want more evidence of long-term impact.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY said it plans to build a $6.5 billion facility in Houston to make active pharmaceutical ingredients, including for a new oral weight-loss drug.
    • “The plant will bring 615 jobs to the area, including engineers and lab technicians, as well as 4,000 construction jobs while it is being built, the company said Tuesday.
    • “Eli Lilly plans to manufacture orforglipron, its first oral, small molecule GLP-1 receptor agonist, at the facility. The company expects to submit orforglipron to global regulatory agencies as a treatment for people with obesity by the end of this year.”
  • Per Fierce Healthcare,
    • “Compared to their peers, hospitals acquired by private equity reduced salary spending, cut staffing levels and experienced higher mortality rates within their emergency departments, according to a Medicare claims analysis published this week in Annals of Internal Medicine.
    • “The research, which reviewed data from 2009 to 2019, also found salary and staffing cuts among the acquired hospitals’ intensive care units, but, unlike EDs, there was no significant difference in mortality compared to other hospitals. Patient transfer rates increased in both settings among the private-equity-acquired hospitals, particularly among sicker patients, and ICU length of stay decreased.
    • “The analysis from University of Chicago, Harvard Medical School and University of Pittsburgh researchers is the latest contribution to a body of peer-reviewed evidence critical of private equity’s increasing presence among healthcare providers. It also follows a similar analysis from 2023 conducted by many of the same authors that spotted a rise in hospital-acquired adverse events among inpatients receiving care at a private-equity-acquired facility.”
  • and
    • “Pharmacy benefit manager Capital Rx has secured $400 million in fresh funding and announced a rebrand to better reflect its expansion beyond the pharmacy space.
    • “The investments include a $252 million series F round and other funding toward its securities, which is expected to close in October. Wellington Management and General Catalyst led the round, and additional supporters include Generation Investment Management, Growth Equity at Goldman Sachs Alternatives, 9Yards Capital, B Capital, Edison Partners, Prime Health Investments and Transformation Capital.
    • “With the infusion of cash, Capital Rx said it plans to lean more into its broader capabilities as a health benefits technology provider and will rebrand as Judi Health, the name of its proprietary tech stack. The company said the shift “marks a pivotal moment in addressing the fundamental inefficiencies of health benefits administration and the rising cost of care in the U.S.”
    • “The funding will also support the expansion of its PBM operations, Capital Rx said.”
  • and
    • “Health insurance startup Sidecar Health inked a partnership with Carrum Health to bring its specialty care network onto its platform.
    • “Carrum Health, a Fierce 15 of 2025 honoree, launched 10 years ago to develop value-based Centers of Excellence for employers, with the aim to revamp how the healthcare industry pays for and delivers specialty care. 
    • “Sidecar Health members will now have access to more than 1,200 vetted COE providers for surgical, cancer and substance use treatment—accessible to 90% of Americans within 50 miles of a Carrum provider, according to the companies. 
    • “Carrum’s solution makes specialty care services available at bundled prices and connects members to dedicated care navigation. The service also includes a 30-day warranty on surgery and two years on cancer care.”
  • Beckers Hospital Review relates,
    • “Walmart has expanded same-day pharmacy services to include refrigerated and reconstituted medications. 
    • “The expansion includes refrigerated access for medications such as insulin, GLP-1s and pediatric amoxicillin, according to a Sept. 22 news release from the company. Refrigerated medications make up over 30% of Walmart pharmacy sales and the company is the first retailer to deliver refrigerated prescriptions alongside everyday orders. 
    • “Once a prescription is filled, customers are notified through their Walmart pharmacy account and from there, can choose same-day scheduled delivery, on-demand delivery and express delivery with insurance applied.” 
  • BioPharma Dive tells us “why Xoma, a drug royalty firm, is hunting biotech ‘zombies.’ Distressed biotechs are facing rising investor pressure to close down, giving firms like Xoma an opportunity to step in and liquidate them for a profit.”
  • MedTech Dive explains “how SS Innovations is expanding robotic surgery’s reach. Heart surgeon Sudhir Srivastava saw a global need for less-invasive surgical care at an affordable price. His company, SS Innovations, built a robot that has now been used in over 5,000 surgeries.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • The Wall Street Journal reports,
    • “The collapse on Friday [September 19] of an emergency federal funding bill leaves the fate of cybersecurity legislation that provides legal protection for companies sharing cyber-threat intelligence up in the air.
    • Without a reprieve of the expiring cyber legislation that had been included in the funding bill, companies face uncertainty on how to communicate about cyber threats as competing reauthorization bills work through a divided House and Senate.
    • “Both the private sector and the government need certainty, including the ability to allocate resources for long-term cybersecurity planning and implementation,” said Matthew Eggers, vice president of cybersecurity policy at the U.S. Chamber of Commerce. 
    • The 2015 Cybersecurity Information Sharing Act, or CISA, is set to expire at the end of September. Friday’s scuttled emergency funding measure, which applied to a number of federal programs and sought to avert a government shutdown, would have given lawmakers more time [until November 21] to iron out critical differences between House and Senate versions of CISA renewal bills. * * *
    • “A notable difference in the House bill is the forward-thinking inclusion of artificial intelligence in the renewal,” said Justine Phillips, a partner and co-chair of the data and cyber practice group at law firm Baker McKenzie. Despite these updates, she said, “the House bill is the functional equivalent of extending the act as is, because it leaves the legal liability protections intact.”
    • “The cyber bill’s renewal by the Senate may prove more problematic, cybersecurity experts say.”
  • Cyberscoop informs us,
    • “Federal agencies are increasingly incorporating artificial intelligence into the cyber defenses of government networks, and there’s more still to come, acting Federal Chief Information Security Officer Michael Duffy said Thursday.
    • “We’re at an exciting time in the federal government to see that we’re not only putting AI in production, but we’re finding ways to accelerate emerging technology across the government, across all missions and all angles,” Duffy said at FedTalks, produced by Scoop News Group. In his “role overseeing federal cybersecurity policy,” he said, he is “able to see these at the ground level, as agencies bring excitement and enthusiasm and hope for what they can optimize through artificial intelligence.”
    • “Cyber attackers are moving faster than ever, and on a much larger scale than before, he said. They’re also using technology in new ways. But it’s not all “doom and gloom” when it comes to the cybersecurity of federal networks, especially because of feds’ move toward AI, Duffy said.
    • “I’m pleased to say that the advancements that we’ve made over the past decade in the federal government have brought us to this point: Agencies are poised now, postured, positioned, to take advantage of new capabilities, bring them into federal agencies and make them work for the mission,” he said.”
  • In related news, Cybersecurity Dive tells us,
    • “The National Institute of Standards and Technology on Thursday [September 18] published guidance describing how implementation of post-quantum cryptography (PQC) both supports and relies on the safeguards in the agency’s major cybersecurity publications.
    • “The draft NIST document, derived from the output of the agency’s PQC migration project, is designed to illustrate the connections between the tools required for adopting quantum-resistant encryption and the security practices that NIST recommends in its Cybersecurity Framework and other guidance.
    • “The capabilities demonstrated in the project support several security objectives and controls identified” in other NIST guidance documents, the agency said in its new publication. “At the same time, responsible implementation of the demonstrated capabilities is dependent on adherence to several security objectives and controls identified in these risk framework documents.”
    • “Collecting information about which technologies use cryptography supports the Cybersecurity Framework practices of creating hardware and software inventories, the document notes. Similarly, analyzing cryptographic weaknesses supports the CSF practice of identifying vulnerabilities in technology assets.”
  • A September 19, 2025, NIST news release adds,
    • “To help organizations protect their data against possible future attacks from quantum computers, the National Institute of Standards and Technology (NIST) has released a publication offering guidelines for implementing a class of post-quantum cryptography (PQC) algorithms known as key-encapsulation mechanisms, or KEMs.
    • “A KEM is a set of algorithms that can be used by two parties to securely establish a shared secret key over a public channel — a sort of first handshake between parties that want to exchange confidential information. Recent examples of KEMs include ML-KEM and HQC.
    • The new publication, Recommendations for Key-Encapsulation Mechanisms (NIST Special Publication 800-227), describes the basic definitions, properties and applications of KEMs and provides recommendations for implementing and using KEMs securely.
  • Cyberscoop reports,
    • “Two teenagers were arrested in the United Kingdom this week, accused of associating with the sprawling criminal collective known as The Com, and participating in many high-profile and damaging cyberattacks on critical infrastructure globally.
    • “Thalha Jubair, 19 of London, and Owen Flowers, 18 of Walsall, England, were arrested at their residences Tuesday and charged with crimes related to the cyberattack on the Transport for London in September 2024, the U.K.’s National Crime Agency said.
    • “Jubair and Flowers were allegedly highly involved in many other cyberattacks attributed to Scattered Spider, a nebulous offshoot of The Com that commits ransomware and data extortion. The Com is composed of thousands of members, splintered into three primary subsets of interconnected networks that commit swatting, extortion and sextortion of minors, violent crime and various other cybercrimes, according to the FBI.
    • “The Justice Department on Thursday unsealed charges against Jubair, a U.K. national, accusing him of participating in at least 120 cyberattacks as part of Scattered Spider’s sweeping extortion scheme from May 2022 to September 2025, including 47 U.S.-based organizations. Victims of those attacks paid at least $115 million in ransom payments, authorities said.”

From the cybersecurity vulnerabilities and breaches front,

  • While CISA did not add any known exploited vulnerabilities to its catalog this week, SC Media lets us know,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) on Sept. 18 issued a malware analysis report on two sets of malicious code from an organization compromised by threat actors exploiting two bugs in the Ivanti Endpoint Manager Mobile (EPMM) tool.
    • “CISA said the malware exploited two CVEs – CVE-2025-4427 and CVE-2025-4428. After exploitation, the malware let the threat actors inject and run arbitrary code on the compromised server.
    • “Lawrence Pingree, technical evangelist at Dispersive Holdings, said malware that’s instrumented to target specific vulnerabilities in centralized endpoint management solutions like these Ivanti tools is incredibly important to defend against.
    • “Isolating and microsegmenting sensitive systems like this is essential. Patching rapidly, ideally with an automated process, is essential in defending against vulnerabilities,” said Pingree.”
  • Per Dark Reading,
    • “Security vendor SonicWall suffered a data breach that exposed customer firewall configuration file backups.
    • “On Sept. 17, SonicWall, a vendor best known for its network security appliances, published a knowledge base article disclosing what it described as a “cloud backup file incident.” The company said its security teams recently detected “suspicious activity targeting the cloud backup service for firewalls” and confirmed it to be a security event in the past few days.
    • “Unidentified threat actors accessed backup firewall preference files stored in the cloud representing “fewer than 5% of our firewall install base,” according to SonicWall. Attackers were able to access encrypted credentials as well as firewall configuration files “that could make it easier for attackers to potentially exploit the related firewall.”
    • “We are not presently aware of these files being leaked online by threat actors,” SonicWall said in its disclosure. “This was not a ransomware or similar event for SonicWall, rather this was a series of brute force attacks aimed at gaining access to the preference files stored in backup for potential further use by threat actors.”
  • Per Cyberscoop,
    • “Researchers warned that a maximum-severity vulnerability affecting GoAnywhere MFT bears striking similarities with a widely exploited defect in the same file-transfer service two years ago.
    • “Fortra, the cybersecurity vendor behind the product, disclosed and released a patch for the vulnerability — CVE-2025-10035 — Thursday. The deserialization vulnerability “allows an actor with a validly forged license response signature to deserialize an arbitrary actor-controlled object, possibly leading to command injection,” the company said in a security advisory.
    • “File transfer services are a valuable target for attackers because they store a lot of sensitive data. If cybercriminals exploit these services, they can quickly access information from many users at once, making these services especially attractive for large-scale attacks. 
    • “Fortra didn’t provide any evidence of active exploitation and researchers from multiple security firms said they haven’t observed exploitation but expect that to change soon. “We believe that it’s just a matter of time and are monitoring the situation closely,” Ryan Dewhurst, head of proactive threat intelligence at watchTowr, said in an email.
    • “The vulnerability, which has a CVSS rating of 10, is “virtually identical to the description for CVE-2023-0669,” a zero-day vulnerability exploited by Clop, resulting in attacks on more than 100 organizations, and at least five other ransomware groups, Caitlin Condon, vice president of security research at VulnCheck, said in a blog post.”
  • and
    • “Apple’s latest operating systems for its most popular devices — iPhones, iPads and Macs — include patches for multiple vulnerabilities, but the company didn’t issue any warnings about active exploitation. 
    • “Apple patched 27 defects with the release of iOS 26 and iPadOS 26 and 77 vulnerabilities with the release of macOS 26, including some bugs that affected software across all three devices. Apple’s new operating systems, which are now numbered for the year of their release, were published Monday as the company prepares to ship new iPhones later this week.
    • “Users that don’t want to upgrade to the latest versions, which adopt a translucent design style Apple dubs “liquid glass,” can patch the most serious vulnerabilities by updating to iOS 18.7 and iPad 18.7 or macOS 15.7. Most Apple devices released in 2019 or earlier are not supported by the latest operating systems.
    • “None of the vulnerabilities Apple disclosed this week appear to be under active attack, Dustin Childs, head of threat awareness at Trend Micro’s Zero Day Initiative, told CyberScoop.”
  • Cybersecurity Dive points out,
    • “Most companies worry their networks aren’t safe against cyberattacks powered by artificial intelligence.
    • “Only 31% of IT leaders are at least somewhat confident that they can defend their organizations against AI-powered attacks, according to a Lenovo report published on Thursday.
    • “The report delves into why IT and security leaders are worried about hackers’ use of AI — and why they see their companies’ own use of AI systems as vulnerable.”
  • and
    • “The number of healthcare organizations that have lost more than $200,000 to cyberattacks has quadrupled this year compared with the same period in 2024, data security firm Netwrix said in a report published Thursday [September 19].
    • “Nearly half of all healthcare organizations (48%) experienced at least one intrusion between March 2024 and March 2025, the report found.
    • “Healthcare organizations experienced more cyberattack-related losses of at least $500,000 than critical infrastructure firms did, on average: 12% of healthcare organizations, compared with 6% of all organizations.”

From the ransomware front,

  • Infosecurity Magazine reports,
    • “Fifteen well-known ransomware groups, including Scattered Spider, ShinyHunters and Lapsus$, have announced that they are shutting down their operations.
    • “The collective announcement was posted on Breachforums, where the groups claimed they had achieved their goals of exposing weaknesses in digital infrastructure rather than profiting through extortion.
    • “In their statement, the gangs said they would now shift to “silence,” with some members planning to retire on the money they had accumulated, while others would continue studying and improving the systems people rely on daily.” * * *
    • “Organizations should take these announcements with a pinch of salt,” Nivedita Murthy, senior staff consultant at Black Duck, said.
    • “It could be possible that some of these groups may have decided to step back and enjoy their payday, [but] it does not stop copycat groups from rising up and taking their place.”
  • IT Pro discusses the “top ransomware trends for businesses in 2025. A splintering of top groups and changing attitudes toward payments are changing attacker tactics at speed.”
  • Morphisec calls attention to “The Top Exploited Vulnerabilities Leading to Ransomware in 2025 — and How to Stay Ahead.” 

From the cybersecurity defenses front,

  • The American Hospital Association News reports,
    • “Microsoft Sept. 16 announced it had disrupted a growing phishing service that had targeted at least 20 U.S. health care organizations. The company said it used a court order granted by the U.S. District Court for the Southern District of New York to seize 338 websites associated with RaccoonO365, a cyber threat group known for stealing Microsoft 365 credentials through phishing tactics. RaccoonO365 offers subscription-based phishing kits that allow individuals to steal Microsoft credentials by mimicking official Microsoft communications. The company said the phishing kits use Microsoft branding to create fraudulent emails, attachments and websites. Since July 2024, the kits have stolen at least 5,000 Microsoft credentials from individuals in 94 countries. The group was recently observed offering a new artificial intelligence-powered service in an attempt to scale their operations.
    • “Credentials stolen through RaccoonO365 enabled ransomware attacks against hospitals, posing a direct threat to patient and community safety,” said John Riggi, AHA national advisor for cybersecurity and risk. “This operation also highlights a disturbing trend — cybercriminals’ increased use of ‘initial access brokers’ to steal credentials and AI to accelerate the effectiveness, sophistication and impact of cyberattacks. The need for continued and evolving social engineering training for staff is essential to defend against the latest deception tactics used by hackers.”
  • Cybersecurity Dive tells us,
    • “Preemptive cybersecurity solutions will account for about half of all IT security spending by the year 2030, a significant increase from its 5% share in 2024, Gartner said in a report published Thursday.
    • “Preemptive cybersecurity will effectively replace standard detection and response technologies as the preferred defense against malicious hacking, Gartner predicted.
    • “The technology uses artificial intelligence and machine learning to anticipate threats and then neutralize them before they can compromise their targets, according to researchers.”
  • Security Week reflects on the fifteen anniversary of the Zero Trust strategy.
    • “The implementation of zero trust is essential for cybersecurity: but after 15 years, we’re still not there. Implementation is like the curate’s egg: good in parts.
    • “Zero Trust turned fifteen years old on September 14, 2025. Its invention was announced with Forrester’s publication of John Kindervag’s paper, No More Chewy Centers: Introducing The Zero Trust Model of Information Security, on that date in 2010 (archived here).
    • “Zero trust recognizes that treating cybersecurity like an M&M (a hard crunchy shell impenetrable to hackers protecting a soft chewy center where staff can work freely and safely) simply doesn’t work. “Information security professionals must eliminate the soft chewy center by making security ubiquitous throughout the network, not just at the perimeter,” wrote Kindervag.
    • “This is the basis of zero trust (or ZT): abandon the old concept of a barrier between two separate networks (one untrusted: the internet; and one trusted: the enterprise). Instead, trust nothing and verify everything, regardless of source or destination. The concept is sound and rapidly gained approval, culminating in EO14028 mandating that federal agencies must move toward a zero trust architecture while private companies should do similar – but never defining how it could be achieved.
    • “There’s the rub. Zero trust is fundamentally a concept where implementation will depend on individual different corporate ecospheres.”
  • Dark Reading recommends “Transforming Cyber Frameworks to Take Control of Cyber-Risk.”
  • Here’s a link to Dark Reading’s CISO Corner.

Thursday report

David Ermer–ACA, CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, NCQA, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “Top Senate Republicans and Democrats reached a deal Thursday night to tee up two votes on Friday on the two parties’ competing approaches to averting a partial government shutdown when current agency funding expires at the end of the month.
    • “Under the agreement announced by Senate Majority Leader John Thune, R-S.D., and Minority Leader Charles E. Schumer, D-N.Y., assuming the House passes the GOP-drafted, seven-week continuing resolution, then the Senate would take up Democrats’ alternative proposal first. That would be subject to a 60-vote threshold for passage.
    • “If Democrats can’t get 60 votes for their bill — which they aren’t expecting — then the chamber would proceed to a vote on the House-passed CR, also with a 60-vote threshold. That vote is also not expected to succeed.”
    • “However, the idea is for the two sides to head home for the weekend armed with proof that they have to start talking to each other about a compromise that can get 60 votes and get to President Donald Trump’s desk in time to prevent a shutdown.
    • “Schumer had proposed the arrangement earlier in the day, with an eye toward getting the initial votes over with in time for senators to attend conservative activist Charlie Kirk’s funeral in Arizona on Sunday.”
  • Roll Call adds,
    • “Democratic and Republican congressional leaders were engaging in a game of shutdown chicken Thursday, the day before the House’s expected vote on a seven-week stopgap bill due Sept. 30 to prevent a lapse in federal agency funding.
    • “House GOP leaders were feeling good about their odds of getting the bill through their chamber Friday morning, although they still had a little work to do on their side shoring up concerns about added member security funds in the continuing resolution being too skimpy, at $30 million. 
    • “Optimistic, but not certain,” House Appropriations Chairman Tom Cole, R-Okla., responded Thursday when asked for his outlook on passage.”
  • Per Congressional news releases
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, highlighted the importance of delivering President Trump and Secretary Kennedy’s mission to restore radical transparency at the U.S. Centers for Disease Control and Prevention (CDC) to protect children’s health.
    • “This comes after the HELP Committee held a hearing with former CDC officials Susan Monarez, PhD, and Debra Houry, M.D., about the recent high-profile departures from the agency. To deliver on the President’s mission of radical transparency, the Committee is inviting U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and HHS officials to respond by speaking with Committee members.”
  • and
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a statement following the U.S. Senate passage of the SUPPORT for Patients and Communities Reauthorization Act, which bolsters prevention, treatment, and recovery services for Americans with substance use disorders and mental illness. Earlier this year, the U.S. House of Representatives passed the bill with strong bipartisan support. The SUPPORT Reauthorization Act now heads to President Trump’s desk for signature.
    • “The opioid and mental health crisis is tearing apart families,” said Dr. Cassidy. “The SUPPORT Act equips communities with vital tools to combat this scourge and save lives. I’m grateful to my colleagues for their work to pass this bill and look forward to it being signed into law.”
  • MedTech Dive tells us,
    • “A House of Representatives committee has advanced a bill that would give eligible breakthrough devices four years of Medicare coverage.
    • “The House Ways and Means Committee debated the bill Wednesday, revealing concerns about the risk of fraud, the type of evidence required and the weakening of the Centers for Medicare and Medicaid Services’ authority.
    • “Despite the concerns, the bill received bipartisan support and was passed in a 38 to 3 vote. Two medtech trade groups welcomed progress on a topic that they have lobbied about for years.”
  • Beckers Payer Issues notes,
    • “Senate and House [Democrat] lawmakers have introduced a bill that would bar health insurers from buying independently owned clinics and require existing conglomerates to divert their provider businesses.  
    • “The Patients Over Profits Act would:
      • “Prohibit insurance companies or their subsidiaries from owning Medicare Parts B and C providers 
      • “Require insurers and their subsidiaries who also own Parts B or C providers to divest, and if they do not, a civil lawsuit can be brought by the Federal Trade Commission, state attorneys general, HHS inspector general or the Justice Department’s antitrust division. 
      • “Bars the HHS secretary from contracting with a Medicare Advantage organization that also owns a Part B or C provider.” 
  • and
    • “Three Medicare Advantage plans scored a full five stars in this year’s health plan rankings from the National Committee for Quality Assurance.
      • Kaiser Foundation Health Plan in Southern California – HMO
      • Kaiser Foundation Health Plan in Northern California – HMO
      • Network Health in Wisconsin – PPO
    • “An additional 17 plans, including six more Kaiser Foundation Health Plans from around the country, scored 4.5 stars in 2025.”
  • The Wall Street Journal reports,
    • Health secretary Robert F. Kennedy Jr.’s handpicked slate of vaccine advisers voted [8-3] to no longer recommend a combined shot for measles, mumps, rubella and varicella [chickenpox (MMRV)] for children under age 4. 
    • The move came as some states, insurers, public health leaders and a U.S. senator called into question whether Americans should rely on the committee’s decisions.
  • The FEHBlog listened to a good chunk of today’s meeting, and the ACIP decision was based on a concern about children under age 4 suffering febrile seizures as a result of the MMRV shot.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) today announced it is moving to decertify a major organ procurement organization (OPO) after an investigation uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors. In one 2024 case, a mistake led a surgeon to decline a donated heart for a patient awaiting transplant surgery.
    • “CMS’s decertification of the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, is part of Secretary Robert F. Kennedy, Jr.’s reform initiative announced in July. At that time, an HHS investigation into another OPO found that at least 28 patients may not have been deceased at the time of organ preparation, 73 patients showed neurological signs incompatible with donation, and the Biden administration had closed its own investigation without action.”
  • OPM Director Scott Kupor added to his blog last Monday September 15 with a post titled “Sorry, Not Everyone Gets an A.” In a related news release, OPM explains Director Kupor’s latest blog post explains why an OPM final rule published September 15 “promotes excellence and accountability.”
  • Federal News Network informs us,
    • “The Office of Personnel Management is putting a pause on plans to relocate some of its employees, but said “new efforts” to do so are underway.
    • “In February, OPM gave remote employees more than 50 miles away from the office an ultimatum: Agree to a “management-directed reassignment” (MDR) and relocate to office space in another geographic region, or face termination.
    • “OPM said it would cover relocation expenses for employees who accept reassignment and gave employees until March 7 to make their decision.
    • “But in a new memo, obtained by Federal News Network, the agency states “relocation efforts for OPM employees are on pause.”
    • “The memo said all employees should continue to work at their current duty station, and that “there is no longer an expectation that the first cohort of employees will be relocated to their new duty station by December 2025.”
    • “The memo suggests OPM is taking a fresh look at relocation plans under OPM Director Scott Kupor, who took office in July.“
  • Tammy Flanagan writing in Govexec, follows up on her article from last week about picking the best date for federal retirement in 2026.

From the Food and Drug Administration front,

  • MedPage Today points out,
    • “The FDA gave premarket approval to the first medical device for the treatment of women with symptomatic moderate-to-severe intrauterine adhesions, known as Asherman syndrome, maker Womed announced on Tuesday.
    • “The resorbable adhesion barrier device (Womed Leaf) is intended for women undergoing hysteroscopic surgery for Asherman syndrome.
    • “Asherman syndrome is caused by scarring of the uterus after procedures such as dilation and curettage or fibroid removal and can occur in 20% to 45% of those procedures. The condition can cause female infertility, pelvic pain, and recurrent miscarriages. Current treatment options for intrauterine adhesions have high recurrence rates.” * * *
    • “Womed said the device will be available in the U.S. in early 2026.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules to laboratory-developed tests. The final rule is in response to a March 31 federal district court decision that also vacated the FDA’s 2024 final rule. The AHA previously urged the FDA to not apply the 2024 final rule to hospital and health system LDTs when it was proposed. 
    • “The AHA appreciates that FDA and the federal district court have acknowledged the unique value and safety of laboratory tests developed by hospitals and health systems for direct use in patient care,” said Roslyne Schulman, AHA director of outpatient payment, emergency readiness and public health policy. “The return to enforcement discretion for LDTs rightly recognizes that applying the device regulations to these tests would likely prompt many hospital laboratories, particularly small ones, to stop offering safe and effective tests upon which patients and their communities rely. This action will help to assure patient access to innovative and targeted diagnostic tests while reducing regulatory burden and costs for both hospitals and the federal government.”
    • “Today’s final rule will become effective following official publication in the Federal Register Sept. 19.”

From the public health and medical/Rx research front,

  • The Wall Street Journal relates,
    • “Novo Nordisk’s daily Wegovy pill led to similar weight loss as the weekly injection in a late-stage trial.
    • “The Wegovy pill, already under review, could be the first GLP-1 pill approved for weight loss.
    • “Trial results showed improved cardiovascular risk factors and increased daily activity for patients.
    • “Currently, less than 2% of individuals with obesity in the U.S. receive obesity medication and Wegovy in a pill may also address patient preference for oral treatment,” Martin Holst Lange, chief scientific officer and head of research & development at Novo Nordisk, said.
    • “Pending FDA approval, ample supply will be available to meet the expected U.S. demand as we hope to set a new treatment benchmark for oral weight loss medications,” he added.”
  • and
    • “Lilly and Novo Nordisk haven’t disclosed specific pricing plans for their pills, but some analysts expect them to be priced at a discount to the injectables.
    • “The leading weekly injected medicines, Novo Nordisk’s Wegovy and Lilly’s Zepbound, have been highly effective at helping people lose significant weight. Zepbound’s highest dose has been shown to help people lose an average of more than 22% of their body weight after more than a year of treatment, while Wegovy can help people lose about 17%. 
    • “Yet their manufacturers have struggled to make enough to meet demand, partly because of limited manufacturing capacity for the complex task of making sterile injectable drugs packaged in an auto-injector device. Making pills is less complex, and there is more global capacity. And, pills don’t require cold-chain distribution and storage, while the injectables need to be kept refrigerated.” * * *
    • “Novo Nordisk may be constrained in how much of its new weight-loss pill it can manufacture because it must cram a lot of the main ingredient into each pill to ensure each person absorbs enough by ingestion, analysts have noted. That is because, like injected semaglutide, the pill is made up of peptides, which are larger than the small molecules that pills are traditionally made of.” * * *
    • Lilly took a different approach than Novo Nordisk. The main ingredient for its GLP-1 pill, orforglipron, is a small molecule, meaning the pills can be manufactured in a more traditional way.
  • Fierce Pharma adds,
    • “Over the last six years, three GLP-1 drugs have been approved for children aged 10 and older with type 2 diabetes. Now this rapidly growing patient population is a step closer to gaining access to Eli Lilly’s dual-action GLP-1/GIP treatment Mounjaro, as its effectiveness in controlling blood sugar has been demonstrated in a phase 3 trial of kids ages 10-17.
    • “The SURPASS-PEDS study—which enrolled 99 children with type 2 diabetes who do not get adequate blood sugar control with metformin, insulin or a combination of both—achieved its primary and secondary endpoints. After 30 weeks of treatment, Mounjaro provided improvements over placebo in the blood sugar measurement, A1C, and in patients’ body mass index (BMI).
    • “The study’s primary endpoint was accomplished, with Mounjaro-treated patients experiencing an average A1C reduction of 2.2% versus .05% for those on placebo from a mean baseline of 8.05%.
    • “Lilly said that it has submitted the results to regulators in a bid to gain an expanded indication for the juggernaut diabetes medication.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “Researchers led by a team at INSERM and King’s College London have shown how stretching the skin stimulates immune cells and increases the skin’s ability to absorb large molecules, including those present in vaccines.
    • “Using a device that applies suction pressure to stretch the skin, the researchers reported that skin stretching activated a local immune response and increased skin permeability without tissue damage via the opening of hair follicles. They also reported that applying vaccines topically while stretching the skin resulted in more effective immunization than subcutaneously injecting the vaccine in mice.”
    • “Just stretching the skin was more effective than delivering the same vaccine with a needle, which shows the practical relevance of this immune activation,” said Stuart Jones, PhD, at King’s College London. “This new pathway into the skin could be used in lots of different ways—we showed its potential for vaccine delivery, but we’re also starting to think about delivering cell therapies and whether it could be used for diagnostics.”
  • Per Healio,
    • “People with obesity and diabetes who undergo bariatric surgery face a significantly lower risk for several adverse health outcomes vs. those treated with GLP-1s, new data show.
    • “Surgery should not be reserved as a last resort; it should be part of early, shared decision-making for patients with type 2 diabetes and obesity,” Ali Aminian, MD, director of Cleveland Clinic’s Bariatric and Metabolic Institute, told Healio. “Evidence shows that surgery provides added, durable benefits beyond medications alone.”
  • Per MedPage Today,
    • “Oral bacteria and fungi may help reshape the pancreatic microbiome and promote carcinogenesis.
    • “Earlier research has connected periodontal disease and clinical candidiasis with greater pancreatic cancer risk.
    • “Altogether, the study identified a more than threefold increase in cancer risk for everyone standard deviation rise in a microbial risk score comprised of 27 bacteria and fungi.”
  • and
    • “One in 10 childhood blood cancers may result from medical imaging-associated radiation exposure.
    • “Cancer risk increased with cumulative radiation dose, ranging from 1.41 times higher to 3.59 times higher.
    • “Children exposed to at least 30 mGy had 25.6 excess blood cancers per 10,000 by age 21.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ascension wrapped its 2025 fiscal year with a $490.9 million operating loss (-1.9% operating income) but a $917.7 million net income, an improvement over the prior year it attributed to greater volumes, improved labor productivity and a tighter rein on non-labor spending.
    • “The major Catholic nonprofit is coming off of a $1.8 billion operating loss in fiscal 2024 and a $3 billion operating loss in fiscal 2023, though those dip to $1.4 billion and $1.5 billion, respectively, when removing impairment and nonrecurring losses. It’d also suffered a major cybersecurity incident at the end of fiscal 2024, the recovery from which leadership said spanned multiple quarters and included consistent volume recovery.
    • “We have been intentional in directing resources toward initiatives that generate measurable impact, from service line growth to process redesign, while also ensuring both stewardship and sustainability,” Saurabh Tripathi, executive vice president and chief financial officer, said in a statement. “This combination of operational discipline and strategic investment increases our flexibility to expand access, enhance services, and ensure the commitment to our mission.”
    • Ascension, which owns or has interests in about 120 hospitals and other healthcare facilities across 16 states, logged $25.3 billion of total operating revenue in fiscal 2025, a roughly $3.2 billion decline (-11.3%) largely reflecting the system’s recent divestments.”
  • The Wall Street Journal relates,
    • “Roche ROG Holding said it agreed to buy 89bio ETNB for up to $3.5 billion, seeking to bolster its drug pipeline by adding an experimental treatment for a liver disease linked to obesity.
    • “The Swiss drugmaker has been looking to enter the weight-loss drug field, a key target of its recent dealmaking activity. With Eli Lilly and Novo Nordisk ahead in the race due to approved drugs that are generating billions of dollars in sales, Roche is betting that a new generation of treatments and potential drug combinations for adjacent conditions can help it to carve out a future role in the market.
    • “The main asset in the pipeline of San Francisco-based 89bio is a drug candidate for a fatty liver disease known as MASH, or metabolic dysfunction-associated steatohepatitis, that is mostly due to obesity.
    • “We intend to be a leader in the cardiovascular space going forward, and being a player in the obesity space is important to make that happen,” Teresa Graham, chief executive of Roche Pharmaceuticals said in an interview.”
  • Per Modern Healthcare,
    • “Cigna aims to strengthen its grip on the specialty pharmacy market through a recent deal with Shields Health Solutions.
    • “The company’s Evernorth Health Services subsidiary, which includes the pharmacy benefit manager Express Scripts and the specialty pharmacy Accredo, announced a $3.5 billion investment into Shields Health Solutions on Sept. 2.
    • “The move shores up a slice of the specialty pharmacy market Cigna wanted to bolster, President and Chief Operating Officer Brian Evanko said during the Morgan Stanley Global Healthcare Conference Sept. 10.” * * *
    • “What caught a lot of people off guard by the [Cigna] transaction is it’s not intuitively the best fit with a retail-oriented PBM,” said Aryeh Sand, a partner at investment banking firm Solomon Partners. “Shields historically is more aligned with health systems.”
  • and
    • “Ten Wisconsin rural hospitals formed a clinically integrated network, following dozens of rural providers that have joined similar initiatives over the past two years. 
    • “The Wisconsin High Value Network looks to pool the expertise and scale of the independent rural hospitals, which have combined $880 million in net revenue, to improve care and lower costs. The Cibolo Health-backed network, announced Thursday, will give providers the data infrastructure and bargaining power to hone primary care services and expand alternative payment models, said David Hartberg, CEO of Vernon Health in Viroqua, Wisconsin, and board chair of the Wisconsin High Value Network.
    • “Cibolo, a rural hospital advisory firm, helped launch similar coalitions in North Dakota, Minnesota, Ohio, Montana and Nebraska. Cibolo will manage daily operations of the Wisconsin High Value Network.”
  • Per BioPharma Dive,
    • “Biogen is buying Alcyone Therapeutics after working with the company for more than two years on a better delivery system for neurological medicines built around antisense oligonucleotides.
    • “Under terms announced Thursday, Biogen will spend $85 million upfront to acquire the privately held company and promise additional payments to Alcyone investors if certain development and regulatory goals are reached. Biogen will gain all rights to ThecaFlex DRx, an implantable subcutaneous port and catheter device it’s been developing with Alcyone since 2023.
    • “The companies have two studies underway testing the system’s delivery of Biogen’s Spinraza drug for spinal muscular atrophy, Biogen said. Lowell, Massachusetts-based Alcyone has been developing ThecaFlex DRx since 2019 and manufactures the product locally.”
  • Per MedTech Dive,
    • “Siemens Healthineers and Stryker are partnering to develop a robotic system that can perform a range of elective and emergency neurovascular procedures, including treatment for strokes and aneurysms, the companies said Wednesday.
    • “The collaboration includes system design, access device and implant integration, imaging for robotic navigation and procedural workflow optimization. The project will combine Siemens Healthineers’ expertise in robotics and imaging with Stryker’s experience in neurovascular technologies.
    • “Carsten Bertram, head of advanced therapies at Siemens Healthineers, said the partnership will focus on creating an ecosystem of image guidance, robotics and devices to help physicians provide faster and more precise care to patients.”
  • Per Fierce Pharma,
    • “With both companies on an upward trajectory, argenx and its manufacturing partner Fujifilm Biotechnologies are taking a logical next step by expanding their collaboration.
    • “In addition to manufacturing drug substance for argenx’s autoimmune blockbuster Vyvgart at its facility in Hillerød, Denmark, Fujifilm will also make the product at its large-scale complex in Holly Springs, N.C. The CDMO will initiate production of Vyvgart at the plant in 2028.
    • “Fujifilm’s Holly Springs is slated to become operational this year and has already secured contracting work from several large drugmakers.” * * *
    • “Fujifilm began building the $2 billion Holly Springs campus in 2021, billing it then as the largest end-to-end biologics production plant in the world, with the expectation to employ roughly 725 at the facility.
    • “Then, in April of last year, Fujifilm upped its ante on the site, earmarking an additional $1.2 billion for its construction and increasing its expected headcount at the facility to 1,400 by 2031.” 

From the artificial intelligence front,

  • Beckers Payer Issues reports,
    • “Hawaii Medical Service Association and Blue Cross and Blue Shield of Kansas joined Blue Shield of California as co-founders of Stellarus, according to a Sept. 18 news release from the technology company. 
    • “Stellarus said it aims to help health plans of all sizes integrate AI and fresh technology to expedite prior authorization, reduce administrative costs and elevate member experience.
    • “Given Hawaii’s size and geographic position, we are better off if we enhance our ability to innovate and grow our technological capacities by investing in Stellarus with like-minded, mission-driven, not-for-profit health plans that are trying to accomplish the same things and solve the same problems,” said President and CEO of Hawaii Medical Service Association Mark Mugiishi, MD.” 
  • Beckers Hospital Review lets us know,
    • “Rochester, Minn.-based Mayo Clinic nurses and informatics teams have developed a [patent pending] in-house AI tool to help streamline clinical workflows.
    • “The tool, called the Nurse Virtual Assistant, integrates directly into Mayo’s EHR and provides a nurse-specific patient summary with links to resources including Lippincott guidelines, intravenous administration protocols and a clinical policy library, according to a Sept. 17 news release.
    • “Mayo Clinic said the tool is designed to reduce the time nurses spend navigating multiple systems, allowing them to focus more on patient care. It was tested and validated in a research study approved by Mayo’s institutional review board before being expanded to more than 9,600 nurses across inpatient and emergency department units.”
  • Per AHA News,
    • “The Joint Commission and the Coalition for Health AI released guidance Sept. 17 on the responsible use of artificial intelligence in health care, the first installment from their partnership that launched in June. The guidance includes recommendations on AI policies, local validation, monitoring and use for interpretation and integration into new or existing processes. CHAI and the Joint Commission plan to release further guidance and a playbook by year’s end.”

Tuesday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • An OPM news release tells us,
    • U.S. Office of Personnel Management (OPM) Director Scott Kupor joined the Ruthless Podcast to discuss a number of wide-ranging topics including OPM’s ongoing efforts to bring top talent into the federal workforce and enhance operational efficiency across government.
    • WATCH HERE
  • The American Hospital Association News informs us,
    • “The House Appropriations Committee today released bill text for a continuing resolution to fund the government through Nov. 21. The bill also extends key health care programs set to expire Sept. 30 through the length of the CR. They include extending the Medicare-dependent Hospital and low-volume adjustment programs, telehealth and hospital at home flexibilities, delaying Medicaid Disproportionate Share Hospital cuts, and extending the Cybersecurity Information Sharing Act. The House is expected to vote on the measure this week. The Senate will follow in an attempt to avert a government shutdown by Sept. 30.”
  • Politico adds,
    • “A group of GOP senators are working on legislation to extend Affordable Care Act subsidies with policy changes designed to win over conservatives, according to four people granted anonymity to disclose private discussions.
    • “This group has gotten “technical assistance” from the Senate Finance Committee, which has jurisdiction over the subsidies, according to two of the sources. The Obamacare subsidies are set to expire at the end of this year.”
  • Per the AHA News,
    • “The House Ways and Means Oversight Subcommittee today hosted a hearing on tax-exempt hospitals. The AHA submitted a statement for the hearing, highlighting the amounts that tax-exempt hospitals spend annually on community benefits and where those funds are spent. The AHA also highlighted its analysis released Sept. 10 that found tax-exempt hospitals provided nearly $150 billion in total benefits to communities in 2022, marking a nearly 50% increase in community benefit spending from 2017. Additionally, the AHA explained why a flexible community benefit approach is best for communities as opposed to suggestions for a definition and evaluation from the Internal Revenue Service.” 
  • Per a Congressional news release,
    • Sens. Chuck Grassley (R-Iowa) and Ben Ray Luján (D-N.M.) reintroduced bipartisan legislation bolstering pharmacists’ ability to serve older Americans in communities that lack easy access to doctors or where pharmacists can provide certain basic medical services.
    • The Pharmacy and Medically Underserved Areas Enhancement Act encourages pharmacists to offer health care services (like health and wellness screenings), immunizations and diabetes management by authorizing Medicare payments for those services where pharmacists are already licensed under state law to provide them. Many states already allow pharmacists to provide these services. However, there is currently no way for pharmacists to receive Medicare reimbursement for providing them. * * *
    • “Grassley and Luján also requested feedback from stakeholders on pharmacists providing services for chronic care needs, given the unique pressing challenges of chronic care among seniors. Text of the request-for-information (RFI) can be found HERE.
    • “The full text of the legislation is available HERE.”
  • Healthcare Dive reports,
    • “Doctors — especially specialists — are pushing back against proposed changes to Medicare payment that would tamp down on reimbursement next year.
    • “Medicare’s proposed physician fee schedule for 2026 includes a base rate hike of 2.5%. But it also includes an efficiency adjustment that would reduce payment by 2.5% for thousands of procedures and changes to how regulators calculate practice expense that would lower reimbursement for services performed in facilities like hospitals.
    • “The reforms are meant to account for increased efficiency in procedures that doctors perform frequently, realign payment for primary and specialty care, and recognize larger indirect costs for doctors in office-based settings.
    • “Many physicians support those goals. But the policy changes themselves are a bad idea, doctors are warning the CMS.”
  • Fierce Healthcare points out,
    • “In its annual health plan ratings, the National Committee for Quality Assurance (NCQA) found that 11 out of 998 rated plans earning top marks, more than double last year’s total. 
    • “Of the 11 plans to achieve a 5-star rating, eight were commercial plans and three were Medicare plans. They included Blue Cross and Blue Shield of Massachusetts, UPMC Health Plan and several Kaiser Foundation Health Plans.  An additional 55 plans earned a 4.5-star rating. Most plans ranked between 3 and 4 stars, same as in 2024. The NCQA says its ratings help consumers and regulators assess the quality and effectiveness of health plans. 
    • “The report found year-over-year improvements in coordination and continuity of care in Medicare. The NCQA also identified progress across nearly all six diabetes-related measures. The Kidney Health Evaluation for Patients with Diabetes metric showed an average increase of over 5% across all product lines. 
    • “Additionally, the NCQA found improved adult and adolescent immunization rates. Though childhood immunization rates continued to decline, they did so at a slower pace than last year.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “A safety issue with certain Boston Scientific defibrillation leads has resulted in a series of new Class I recalls, according to the U.S. Food and Drug Administration (FDA). Unlike some recalls, these do not require a product to be immediately removed from the market. However, there are specific recommendations all clinicians should follow. 
    • “The FDA first shared details with the public about these concerns in early August, noting that some of Boston Scientific’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) were associated with a potential risk of rising low-voltage shock impedance (LVSI). If this occurs, it can make the leads less effective over time. 
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” the agency said at the time.”
  • The AHA News adds,
    • “The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.” 
    • “In addition, the FDA issued an early alert for certain Medline convenience kits containing Medtronic DLP Left Heart Vent Catheters due to issues found with certain lots of cannula products where the catheter may not retain its shape. Medline sent a notice to affected customers that recommended they destroy any affected product after completing the list of recall actions.” 

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy weight-loss drug helps patients stop thinking about food, according to a new study.
    • “According to results of the study, which were presented at a medical conference in Austria, patients taking Wegovy for weight-loss experienced a substantial drop in so-called “food noise”—unwanted and intrusive thoughts about food—alongside improvements in their mental well-being and lifestyle.
    • “Novo Nordisk said the number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy, while 64% of respondents reported improved mental health and 80% reported healthier habits while taking the drug.
    • “It is very encouraging to see these new data from people using Wegovy that, in addition to weight-loss, Wegovy may help quiet disruptive thoughts about food, support improved mental well-being and help enable people to live healthier lives,” said Filip Knop, incoming chief medical officer at Novo Nordisk.
    • “The U.S.-based Inform study released Tuesday surveyed 550 people taking Wegovy for weight-loss to assess the impact of the drug on mental well-being and eating habits relating to food noise.”
  • MedPage Today adds,
    • “A higher 7.2 mg dose of semaglutide led to significantly greater weight loss compared with placebo in adults with obesity, with or without type 2 diabetes.
    • “Participants across two randomized trials also had improvements in cardiovascular risk factors.
    • “Secondary and exploratory analyses suggested that the 7.2 mg dose led to a greater change in body weight versus the currently approved highest dose of 2.4 mg.”
  • Per a National Institutes of Health news release,
    • ‘The National Institutes of Health (NIH) has launched effort aimed at reducing the rate of preventable stillbirths in the United States. Investigators will develop tools, devices and other technologies that have the potential to affect diagnosis and prevention efforts relevant to stillbirth, which occurs in 1 in 160 deliveries in the U.S. About 23,600 stillbirths at 20 weeks or greater gestation are reported annually.
    • “More than 60% of stillbirth cases remain unexplained even after exclusion of common causes, such as congenital abnormalities, genetic factors, and obstetric complications. NIH will fund the Stillbirth Research Consortium for more than $37 million over five years, pending the availability of funds, with $750,000 in co-funding from the Department of Health and Human Services.
    • “This consortium will provide an integrated, collaborative program to support cutting edge research to identify the root causes of stillbirth and inform evidence-based strategies to address stillbirth risks,” said Alison Cernich, Ph.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. “Too many families needlessly face the grief of stillbirth.”
    • “People who have experienced stillbirth are almost five times as likely to experience another stillbirth or other pregnancy associated complication. The rate of stillbirth is considerably higher among Black, American Indian, and Alaska Native people. About 40% of stillbirths that occur during labor and birth are considered potentially preventable.” 
  • Genetic Engineering and Biotechnology News reports,
    • “A novel strategy developed by scientists at Rice University allows scientists to zoom in on tiny segments of proteins inside living cells, revealing localized environmental changes that could indicate the earliest stages of diseases such as Alzheimer’s, Parkinson’s, and cancer. The study results could offer promise for drug screening that targets protein aggregation diseases.
    • “The research team engineered a fluorescent probe known as AnapTh into precise subdomains of proteins, creating a tool that monitors microenvironmental shifts in real time. Unlike conventional techniques that provide only broad signals, this approach reveals how distinct regions of the same protein behave differently during the aggregation process. The work, led by Han Xiao, PhD, professor of chemistry and director of Rice’s SynthX Center, enhances the basic understanding of disease mechanisms and lays the groundwork for identifying drug targets and screening potential therapeutics at an earlier stage.
    • “We essentially built a molecular magnifying glass,” Xiao said. “This allows us to visualize subtle environmental changes that previously went unnoticed, and those early changes often hold the key to understanding protein-related diseases.” Xiao and colleagues reported on their findings in Nature Chemical Biology, in a paper titled, “Real-time imaging of protein microenvironment changes in cells with rotor-based fluorescent amino acids,” in which they concluded: “These results demonstrate that the technology reported in this paper provides a versatile tool for exploring microenvironment changes of protein substructures at high spatial resolution, enabling direct visualization of the local environment around specific amino acid residues.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY unveiled plans to build a $5 billion manufacturing facility in Virginia as part of the drugmaker’s pledge to bolster its domestic medicine production with four new pharmaceutical manufacturing sites.
    • “Eli Lilly said the new plant, located just west of Richmond in Goochland County, will be the first dedicated, fully integrated active pharmaceutical ingredient and drug product facility for its emerging bioconjugate platform and monoclonal antibody portfolio.
    • “The Indianapolis company said the site also will boost its domestic manufacturing of antibody-drug conjugates.
    • “Eli Lilly said the new plant will create more than 650 new company jobs, along with 1,800 construction jobs.
    • “Eli Lilly in February said it would invest $27 billion to build four new pharmaceutical manufacturing sites in the U.S., more than doubling its U.S. capital expansion commitments since 2020 to more than $50 billion.”
  • and
    • “So far this year, more than a dozen drugmakers [, including Lilly,] have pledged to spend more than $350 billion collectively by the end of this decade on manufacturing, research and development and other functions in the U.S., a Wall Street Journal tally of company announcements showed.
    • “The vast majority of our products going into the U.S. are manufactured in the U.S.,” GSK Chief Executive Emma Walmsley said in an interview Tuesday when the company announced its $30 billion U.S. investment in research and development and supply-chain infrastructure over the next five years. “This of course adds to it, and it’s about the new pipeline that’s going through.”
  • Modern Healthcare informs us,
    • “Health systems are revamping pediatric care to fight emergency department overcrowding before Medicaid funding cuts further endanger access. 
    • “Many emergency rooms are full, leading to care delays and provider burnout. Hospital operators have responded by tasking social workers with triage duties and setting up virtual consultations with specialists. They are also consolidating emergency services and asking data analytics companies to better track and predict capacity and utilization trends, health system executives said. 
    • “Health systems have crafted many of these strategies around pediatric patients, who may bear the brunt of the Medicaid cuts authorized by the “One Big Beautiful Bill,” among other federal policy changes, experts said.
    • “The population that will get hit the hardest in emergency medicine will be pediatrics,” said Dr. Ken Heinrich, chief medical officer of emergency medicine at staffing company SCP Health. 
    • “Providers are facing a surge in pediatric mental health issues, fueling care backlogs across hospital emergency departments. Providers have enlisted social workers and adjusted their emergency department layouts to meet that demand.”
  • and
    • “Labcorp has completed its acquisition of BioReference Health’s oncology diagnostic testing assets for up to $225 million. 
    • “The independent laboratory company paid $192.5 million at closing and and could pay up to $32.5 million more in an earn-out tied to the assets’ performance, according to a Monday news release.
    • “Labcorp previously acquired select clinical, reproductive and women’s health diagnostic assets from BioReference last September for more than $237 million.”
  • MedCity News notes,
    • “Berry Street, a nutrition therapy company, has launched its GLP-1 Nutrition Pathway Program, which is meant to provide nutrition support for those starting, taking and getting off of GLP-1s.
    • “The New York City-based company works with health plans and connects patients in need of nutrition support to a network of registered dietitians. It provides personalized treatment plans for patients struggling with weight management, diabetes, heart health, kidney disease and numerous other conditions.”
  • Per a UHC press release,
    • “Building on our March announcement committing to modernize pharmacy payment models, Optum Rx has increased reimbursement minimums for brand drugs for approximately 2,300 independent pharmacies – those not affiliated with a pharmacy services administrative organization (PSAO), chain or other entity – across the country. This move, which went into effect on September 1, 2025, will support the long-term sustainability of pharmacies, which play a critical role in patient care. 
    • “This is the latest announcement from Optum Rx, which continues to expand on initiatives to transform how pharmacies are reimbursed for drugs. Optum Rx first launched improved reimbursement earlier this year, with Epic Pharmacy Network, a PSAO representing more than 1,000 independent pharmacies, being the first PSAO to partner with us.”
  • BioPharma Dive lets us know,
    • “Novartis is broadening its bet on drugs that can destroy disease-causing proteins, agreeing Monday to a new deal with biotechnology company Monte Rosa Therapeutics.
    • “Through the collaboration, the companies will work to develop multiple novel protein “degrading” drugs for immune conditions. Monte Rosa will conduct discovery and early testing before Novartis takes over development for programs it chooses to license. The biotech will get $120 million in upfront cash per deal terms. It could also receive as much as $5.7 billion overall should various development and sales milestones be met, plus royalties on sales of any eventual products.”
    • Monte Rosa is among the many companies pursuing “molecular glue” drugs, which force together a target protein with an enzyme that flags it for destruction by the cell’s waste disposal system. The approach is seen as a way to access tough-to-reach drug targets, and is one of several strategies biotechs are using to degrade harmful proteins, rather than bind and block them as traditional drugs do.
  • Per Beckers Hospital Review,
    • “Amazon has added Fay, a dietitian platform, as the first nutrition care service available through its Health Benefits Connector.
    • “The collaboration allows eligible Amazon customers to discover and enroll in Fay’s insurance-covered nutrition services while browsing for wellness and health benefits, according to a Sept. 16 news release.
    • “Fay connects individuals with registered dietitians based on their goals, health history and insurance eligibility. Services include counseling, preventive care and coaching, which the company said are often available at no cost to patients.”

From the artificial intelligence front,

  • Fierce Healthcare reports,
    • “Healthcare accreditation body URAC is rolling out the nation’s first accreditation program for users and developers of healthcare artificial intelligence. 
    • “The first-in-the-nation program will evaluate risk management, business management and performance monitoring with specific modules for users and developers. URAC accredits organizations ranging from small pharmacies to multistate payer organizations. 
    • The organization, which has been accrediting healthcare organizations for decades, hopes the URAC gold star will help promote trust in AI.
    • “We think that this is a great opportunity to give people that seal of approval, that gold star, that someone independent has gone in behind the scenes and audited to make sure that this is trustworthy,” Shawn Griffin, M.D., CEO and president of URAC, said in an interview.”
  • and
    • “Aegis Ventures’ digital consortium gained three new members as health systems look to collaborate to develop and scale artificial-intelligence-powered health tech solutions and tackle common pain points.
    • “Yale New Haven Health System, Keck Medicine of USC and Hartford HealthCare joined the collaborative, expanding its reach to 14 regional health systems. The consortium, which includes Northwell Health, UPMC, Stanford Health Care and Vanderbilt Health, will codevelop, invest in and deploy health tech solutions alongside Aegis Ventures. 
    • “The partnerships with the three new health systems will accelerate the consortium’s pipeline of companies with two startups set to launch this fall, according to John Beadle, co-founder and managing partner of Aegis Ventures.
    • “Next year, I think we could be more aggressive, just given that the model of the blueprint worked well. We have the right set of partners, the right team, the resources are in place to do it, but I think we’re most focused on seeing this year out really strong,” Beadle said.”
  • and
    • “Healthcare technology and AI company Innovaccer has acquired Story Health, a digital specialty care platform with health system inroads.
    • “Financial terms of the deal, announced Tuesday, were not disclosed. Innovaccer said the deal adds to its scalable Healthcare Intelligence Cloud offering, which in recent months was bolstered by the company’s other strategic acquisitions.
    • “Healthcare doesn’t change through dashboards alone,” Abhinav Shashank, co-founder and CEO of Innovaccer, said in the announcement. “It changes when data and AI power completely new clinical models. Story Health has proven that in specialty care; and we’re excited to bring this technology and clinical expertise to our health system customers nationwide.”
    • “Cupertino, California-based Story Health, a Fierce 15 2024 honoree, launched in late 2020 and has raised about $27 million in funding from backers such as Northpond Ventures, B Capital Group, LRVHealth, Define Ventures and General Catalyst. Its approach combines virtual coaching, biometric monitoring and care team alerts to support patients with chronic conditions between clinical visits.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Nextgov/FCW reports,
    • “A top Cybersecurity and Infrastructure Security Agency official said the agency is prepared to accept any extension Congress authorizes for a fundamental cybersecurity threat intelligence-sharing law, which is set to expire Sept. 30 unless renewed by lawmakers.
    • “We’ll take whatever the Congress decides to authorize us, wherever they see fit within their purview, to authorize and to give us our authorities to be able to use,” Nick Andersen, CISA’s executive assistant director for cybersecurity, told reporters Thursday [September 11] on the sidelines of the Billington Cyber Summit.
    • “The Cybersecurity Information Sharing Act of 2015 lets private sector providers freely transmit cyber threat information to government partners with key liability protections in place, shielding firms from lawsuits and regulatory penalties when sharing threat data with the government.
    • “So at this point, I think my primary concern is if it lapses,” Andersen added. “Give us 30 days for the Congress to do what they need to do. Give us two years. Give us ten years. Give us 50. Whatever you take, we’ll take it. Obviously, we love stability for the organization and stability for our partners to understand how we’re going to protect and exchange information. But really, that’s up to Congress.”
  • Cyberscoop tells us,
    • “The Cybersecurity and Infrastructure Agency is delaying finalization of a rule until May of next year that will require critical infrastructure owners and operators to swiftly report major cyber incidents to the federal government, according to a recent regulatory notice.
    • “Under the Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) of 2022, CISA was supposed to produce a final rule enacting the law by October of this year. But last week, the Office of Management and Budget’s Office of Information and Regulatory Affairs published an update that moved the final rule’s arrival to May 2026.
    • “A CISA official told CyberScoop that the move would give the agency time to consider streamlining and reducing the burden on industry of a previously proposed version of the rule, citing public comments in response to that version, as well as harmonizing the law with other agencies’ cyber regulations.”
  • Cybersecurity Dive lets know,
    • “National Cyber Director Sean Cairncross said [on September 9] the Trump administration plans a whole-of-nation approach in order to combat the threat of malicious cyberattacks from the U.S.’s top geopolitical rivals. 
    • “Cairncross delivered the opening keynote at the Billington Cybersecurity Summit, saying the administration will push forward an aggressive new posture to counter the risks presented by authoritarian regimes like China.” * * *
    • “The Billington keynote marks the first major public remarks by Cairncross since he won Senate confirmation to lead the Office of the National Cyber Director in August.” 
  • FedScoop informs us,
    • “The U.S. government’s acting chief information security officer outlined his three priorities for federal cyber officials over the next year at a cybersecurity event in Washington on Tuesday [September 9], emphasizing the need for collaboration across the government.  
    • “During a fireside chat at the Billington Cybersecurity Summit, acting cyber chief Michael Duffy said focusing enterprise cyber defense, increasing operational resilience, and securing a modern U.S. government are the areas he’s outlined as priorities for the next year in conversations with the federal cyber leaders on the CISO Council. 
    • “He also previewed an upcoming tabletop exercise the CISO Council will be doing in the next month to address operational resilience.” 
  • Cybersecurity Dive points out,
    • “The Cybersecurity and Infrastructure Security Agency said it remains firmly committed to supporting and further enhancing the Common Vulnerabilities and Exposures program, which is a critical program for identifying and mitigating software flaws that can expose computer systems to exploitation. 
    • “Nick Andersen, the new executive assistant director for cybersecurity at CISA, expressed staunch support for the CVE program during a discussion on Thursday at the Billington Cybersecurity Summit in Washington, D.C. 
    • “CISA on Wednesday [September 10] released a road map that outlined its priorities for the CVE program, with the full intention to further develop the program and create a plan for robust funding and wider participation. 
    • Andersen told reporters after the presentation that it’s “exceedingly important” for CISA to be able to grow and expand the program.
    • “The feedback that we’ve gotten consistently is people are looking for somebody to call objective balls and strikes out there,” Andersen said. 
  • Per Federal News Network,
    • “The Pentagon will soon issue more details on its much-hyped effort to “blow up” the Risk Management Framework used to accredit software.
    • “Katie Arrington, who is performing the duties of the Defense Department chief information officer, said DoD will unveil the “10 commandments” of the “new RMF” in the next couple of weeks. DoD’s work to revamp how it accredits software has been a top discussion point in federal technology circles in recent months.
    • “It’s the 10 tenants of the new RMF,” Arrington said at the Billington Cyber Summit on Thursday.
  • Cyberscoop notes,
    • “The Department of Justice unsealed an indictment against a Ukrainian national alleged to be central to a ransomware campaign affecting hundreds of companies worldwide. 
    • “Volodymyr Viktorovych Tymoshchuk, known online as “deadforz,” “Boba,” “msfv,” and “farnetwork,” is accused of developing and deploying ransomware variants Nefilim, LockerGoga, and MegaCortex, all of which have been used in attacks on prominent organizations in the United States, Europe, and elsewhere since at least 2018.
    • “According to the indictment, filed in the Eastern District of New York, Tymoshchuk and his alleged co-conspirators are believed to have extorted more than 250 companies across the U.S. and hundreds more globally, generating tens of millions of dollars in damages. Victims suffered not just the loss of data and disabling of business operations, but high mitigation and recovery costs. * * *
    • “Additionally, the State Department announced rewards totaling up to $10 million for information leading to the arrest or conviction of Tymoshchuk, with a separate reward of up to $1 million for information on other key leaders of the groups deploying the ransomware variants.”

From the cybersecurity vulnerabilities and breaches front,

  • CISA added one known exploited vulnerability to its catalog this week.
  • Cybersecurity Dive reports,
    • “A sophisticated phishing-as-a-service operation has been targeting Google and Microsoft accounts and can bypass traditional defense mechanisms, including multifactor authentication, researchers at Okta Threat Intelligence warned in a blog post on Thursday, 
    • “The phishing operation, dubbed VoidProxy, uses adversary-in-the-middle techniques to bypass normal authentication flow. 
    • “Researchers first learned of attacks linked to the operation in January, but Dark Web advertisements for VoidProxy appear to have begun as early as August 2024, according to Okta researchers. The attacks are ongoing, and Okta said they have targeted valuable accounts.”  * * *
    • “Google agrees with recommendations in the Okta report that users should adopt passkeys as a strong method to protect against phishing, the spokesperson added.
    • “Microsoft declined to comment, however a spokesperson provided a link with general mitigation guidance.”
  • Dark Reading adds,
    • “A recent phishing campaign that used the Salty2FA phishing kit demonstrates how the cybercriminal enterprise continues to evolve to the point where adversarial tools are nearly on par with enterprise-grade software, experts said.
    • “Researchers from Ontinue tracked a campaign using the phishing kit that shows various technical innovations in which cybercriminals are approaching phishing infrastructure “with the same methodical planning that enterprises use for their own systems,” Rhys Downing, an Ontinue threat researcher, wrote in a blog post published Tuesday.”
  • CSO tells us,
    • “Attackers are increasingly exploiting generative AI by embedding malicious prompts in macros and exposing hidden data through parsers.
    • “The switch in adversarial tactics — noted in a recent State of File Security study from OPSWAT — calls for enterprises to extend the same type of protection they already apply to software development pipelines into AI environments, according to experts in AI security polled by CSO.
    • “Broadly speaking, this threat vector — ‘malicious prompts embedded in macros’ — is yet another prompt injection method,” Roberto Enea, lead data scientist at cybersecurity services firm Fortra, told CSO. “In this specific case, the injection is done inside document macros or VBA [Visual Basic for Applications] scripts and is aimed at AI systems that analyze files.”
    • “Enea added: “Typically, the end goal is to mislead the AI system into classifying malware as safe.”
  • Per InfoSecurity Magazine,
    • “People are often described as one of the biggest security threats to any organization. At first glance, it would be hard to argue with such a sweeping statement.
    • “Whether the result of malice or negligence, the ‘human element’ featured in around 60% of data breaches over the past year, according to Verizon. A recent spate of attacks targeting corporate Salesforce instances highlights the evolving nature of the social engineering threat – and just what’s at stake.
    • “The challenge for CISOs is that insider risk is not just about negligence. Those intent on wrongdoing are usually harder to spot and exact a much heavier toll on their employer. To coincide with International Insider Threat Awareness Month, we take a look at what CISOs can do to push back the tide.”
    • Check it out.

From the ransomware front,

  • Per Security Week,
    • “Ransomware remains the primary digital threat to business. Phishing, often the initial point of failure, further expands into voice triggered transfer fraud.
    • “An analysis of risk based on cyberinsurance claims history provides an accurate overview of the true risk of cybercrime. It doesn’t provide a full global picture of risk since it can only be drawn from known cyberinsurance claims. Resilience is a cyberinsurance provider with a deep knowledge of cybersecurity.
    • “There are three major takeaways from the 2025 Midyear Cyber Risk Report produced by Resilience: vendor-related risk is down but still significant; ransomware remains the main threat; and phishing has leapt to clear prominence as the most common point of failure (aided in scale and sophistication by AI).
    • “The report notes a reduction in vendor-related risk (down from 22% of incurred losses in 2024 to 15% in H1 2025), but stresses that the downstream loss to affected companies remains high. “While incidents dropped in frequency, clients who experienced business interruption from a vendor-related incident had significant losses that rivaled losses from companies directly affected by ransomware.” This is an unseen risk that can only be addressed by continuously monitoring the vendors’ security posture.”
  • Per Check Point Research,
    • “First observed on September 5, Yurei is a newly emerged ransomware group that targeted a Sri Lankan food manufacturing company as its first leaked victim. The group follows a double-extortion model: they encrypt the victim’s files and exfiltrate sensitive data and then demand a ransom payment to decrypt and refrain from publishing the stolen information.
    • “Check Point Research (CPR) determined that Yurei’s ransomware is derived with only minor modifications from Prince-Ransomware, an open-source ransomware family written in Go. This highlights how open-source malware significantly lowers the barrier to entry for cybercriminals, enabling even less-skilled threat actors to launch ransomware operations.
    • “Yurei’s ransomware contains a flaw that may allow partial recovery through Shadow Copies, but the group primarily relies on data-theft-based extortion. As they stated on their blog, the fear and implications of data leakage are their main pressure point to get victims to pay the ransom.
    • “Since the first victim was listed on September 5, the number of victims has risen to three so far, pointing to a fast-growing operation.
    • “The investigation revealed hints that the threat actor’s origins may be in Morocco.”
  • Per Cyberscoop,
    • “Researchers and authorities are warning that Akira ransomware attacks involving exploits of a year-old vulnerability affecting SonicWall firewalls are on the rise. 
    • “A burst of about 40 attacks linked to CVE-2024-40766 hit SonicWall firewalls between mid-July and early August. Researchers have since observed another wave of ransomware attacks linked to active exploits of the defect, which affects the secure sockets layer (SSL) VPN protocol in multiple versions of SonicWall firewalls, and configuration errors. 
    • “Rapid7 has responded to a “double-digit number of attacks” related to the vulnerability and a series of misconfigurations in victim environments, the company said, expanding on a blog it published earlier this week.
    • “The Australian Cyber Security Centre also issued an advisory Wednesday noting that it, too, is responding to a recent increase in active exploitation of the defect. “We are aware of the Akira ransomware targeting vulnerable Australian organizations through SonicWall SSL VPNs,” the agency said.”
  • Per PC World,
    • “It’s a story almost as old as time: malware is wreaking havoc on Android devices again. Usually, Android malware aims to steal sensitive data and passwords in order to gain access to online accounts. Less commonly, it installs ransomware to extort large sums of money from users.
    • “A particularly dangerous malware variant that combines both techniques has now been discovered by security experts at ThreatFabric. Known as RatOn, the Trojan infiltrates an Android phone, accesses data, empties bank accounts, then locks the device to blackmail the owner.” * * *
    • “In the case of RatOn, the Trojan likely lands on Android devices through fake apps. Users are redirected to pages that imitate the Google Play Store, where attackers offer applications disguised as common social media apps like TikTok—except it’s malware.: * * *
    • To protect yourself, you should always check whether an app comes from a trustworthy provider. You should also always activate Google Play Protect in the Google Play Store so that apps are scanned for viruses and malware before they’re installed on your device.
  • Bleeping Computer warns,
    • “A recently discovered ransomware strain called HybridPetya can bypass the UEFI Secure Boot feature to install a malicious application on the EFI System Partition.
    • “HybridPetya appears inspired by the destructive Petya/NotPetya malware that encrypted computers and prevented Windows from booting in attacks in 2016 and 2017 but did not provide a recovery option.
    • “Researchers at cybersecurity company ESET found a sample of HybridPetya on VirusTotal. They note that this may be a research project, a proof-of-concept, or an early version of a cybercrime tool still under limited testing.
  • Cyberscoop adds,
    • “Researchers at New York University have taken credit for creating a piece of malware found by third-party researchers that uses prompt injection to manipulate a large language model into assisting with a ransomware attack.
    • “Last month, researchers at ESET claimed to have discovered the first piece of “AI-powered ransomware” in the wild, flagging code found on VirusTotal. The code, written in Golang and given the moniker “PromptLock,” also included instructions for an open weight version of OpenAI’s ChatGPT to carry out a series of tasks — such as inspecting file systems, exfiltrating data and writing ransom notes.
    • “ESET researchers told CyberScoop at the time that the code appeared to be unfinished or a proof of concept. Other than knowing it was uploaded by a user in the United States, the company had no further information about the malware’s origin. 
    • “Now, researchers at NYU’s Tandon School of Engineering have confirmed that they created the code as part of a project meant to illustrate the potential harms of AI-powered malware.”
    • In a corresponding academic paper, the researchers call the project “Ransomware 3.0” and describe it as a new attack method. This technique “exploits large language models (LLMs) to autonomously plan, adapt, and execute the ransomware attack lifecycle.”

From the cybersecurity business and defenses front,

  • Cyberscoop informs us,
    • “Major cyber intrusions by the Chinese hacking groups known as Salt Typhoon and Volt Typhoon have forced the FBI to change its methods of hunting sophisticated threats, a top FBI cyber official said Wednesday.
    • “U.S. officials, allied governments and threat researchers have identified Salt Typhoon as the group behind the massive telecommunications hack revealed last fall but that could have been ongoing for years. Investigators have pointed at Volt Typhoon as a group that has infiltrated critical infrastructure to cause disruptions in the United States if China invades Taiwan and Americans intervene.
    • “Those hacks were stealthier than in the past, and more patient, said Jason Bilnoski, deputy assistant director of the FBI’s cyber division. The Typhoons have focused on persistent access and gotten better at hiding their infiltration by using “living off the land” techniques that involve using legitimate tools within systems to camouflage their efforts, he said. That in turn has complicated FBI efforts to share indicators of compromise (IOCs).
    • “We’re having to now hunt as if they’re already on the network, and we’re hunting in ways we hadn’t before,” he said at the Billington Cybersecurity Summit. “They’re not dropping tools and malware that we used to see, and perhaps there’s not a lot of IOCs that we’d be able to share in certain situations.”
  • The Wall Street Journal reports,
    • “Japanese industrial giant Mitsubishi Electric said Tuesday that it intends to acquire U.S. cybersecurity company Nozomi Networks in a deal valued at about $1 billion.
    • “Nozomi will become a wholly owned subsidiary of Mitsubishi Electric under the terms of the deal and operate independently. The transaction value includes $883 million in cash as well as previous equity.
    • “Nozomi raised $100 million in a 2024 Series E funding round that included several heavyweights in operational technology, such as Mitsubishi Electric and Schneider Electric. Previous investors included Honeywell; the U.S. Central Intelligence Agency’s venture arm, In-Q-Tel; and Johnson Controls. 
    • “Nozomi Chief Executive Edgard Capdevielle said the company will continue to provide services to those prior investors and other companies after the acquisition, which is expected to close in the fourth quarter. 
    • “The fact that we’re now a wholly owned subsidiary of Mitsubishi does not change the fact that we will continue to be vendor-agnostic,” he said.”
  • Dark Reading adds,
    • “F5, a software company that improves application speed and security, today announced its plans to acquire CalypsoAI, a provider of adaptive artificial intelligence (AI) security capabilities. CalypsoAI’s technology will be integrated into the F5 Application Delivery and Security Platform (ADSP), F5 said.
    • Founded in 2018, CalypsoAI focuses on real-time protection against threats targeting AI applications and models, such as prompt injection and jailbreaking. The platform brings threat defense, red teaming at scale, and data security to businesses preparing to launch or adopt generative and agentic AI. CalypsoAI came in second place at RSAC Conference’s Innovation Sandbox earlier this year as a company that protects models and agents with prompt firewalls.
    • “By integrating CalypsoAI features into ADSP, F5 hopes to build modern firewalls and point solutions that can secure AI models, agents, and data flows. Traditional options “can’t keep up,” said François Locoh-Donou, president and CEO of F5, in a statement.”
  • Here’s a link to Dark Reading’s CISO Corner.

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “Republicans moved Thursday to speed up Senate confirmation of President Donald Trump’s nominees by changing the chamber’s rules over the objections of Democrats.
    • “Senators voted 53-45 to allow themselves to change the rules with a simple majority instead of 60 votes — a move known as the “nuclear option.”
    • “The rules change will allow the Senate to confirm multiple people at once, helping to clear a backlog of nearly 150 nominees awaiting floor votes. Republicans argue it is necessary because Democrats have held up the confirmation process by forcing time-consuming votes on each nominee rather than allowing some of them to be confirmed by voice votes, which is faster.
    • “The change excludes Cabinet officials, Supreme Court justices and federal judges, who must be confirmed one by one.”
  • Per an OPM news release,
    • “The U.S. Office of Personnel Management (OPM) announces the 2025 Combined Federal Campaign (CFC), running from October 1, 2025, to December 31, 2025. The CFC provides federal employees and military personnel opportunities to support charitable causes.
    • “OPM supports the generosity of federal employees but is reviewing the program’s administrative costs and declining participation for potential changes in 2026. Read more in OPM Director Scott
    • “Kupor’s latest blog here and read the memo to agencies here.”
  • OPM Director Scott Kupor explains in his blog,
    • “Over the years, participation in the program has continued to decline from its peak – donations have been hovering around $65-70 million over the past few years. At the same time, the costs to administer the program have continued to increase. This year, the Office of Personnel Management (OPM) estimates the program will consume $22 million in outside contractor fees and listing fees to administer the program.
    • “This means for every $1 a federal employee donates, about $0.33 (or 33%) does not reach the charity for which it was intended. Rather, dollars that could be deployed to help sick children, help veterans in need, or help victims of natural disasters get back on their feet, are instead diverted to overhead. * * *
    • “Despite all of this, we at OPM will shortly launch the 2025 CFC, only because many charities have already spent time and money preparing for this over the course of this year. We hope 2025 will be a successful campaign.
    • “But, at the same time, OPM is concerned about excessive administrative costs associated with the CFC, along with steadily declining participation, and it is evaluating changes to the CFC for 2026 (including whether to continue the program).
    • “We believe strongly in charities and in the generosity that Americans continue to show in donating in support of charities – roughly 50% of American households donate. But we also believe donors expect their dollars to benefit the very causes they intend to support and not to lose the effectiveness of their donations because of excessive administrative costs.”      
  • Tammy Flanagan, writing in Govexec, explains what to know before setting your 2026 retirement date.
  • CNBC reports,
    • “Millions of Social Security beneficiaries may see a 2.7% to 2.8% increase to their monthly checks in 2026, according to new estimates based on the latest government inflation data.
    • “A 2.8% Social Security cost-of-living adjustment may go into effect next year, estimates Mary Johnson, an independent Social Security and Medicare policy analyst. That increase would push the average retirement benefit up by about $54.70 per month, she said. * * *
    • “Those estimated increases would be up from the 2.5% boost to benefits that went into effect in 2025. The COLA has averaged 2.6% over the past 20 years, according to the Senior Citizens League.”
    • “The COLA projections are based on new consumer price index data for the month of August that was released Thursday.
    • “The official Social Security cost-of-living adjustment will include one more month of inflation data.”
  • The American Hospital News tells us,
    • “The Federal Trade Commission announced yesterday that it sent letters to many large health care employers and staffing firms, urging them to review their employment agreements — including any noncompete agreements — to ensure they are in compliance. The commission’s announcement follows one from Sept. 5, when it moved to vacate a 2024 noncompete final rule, voting 3-1 to dismiss appeals initiated by the previous administration attempting to uphold it. On Sept. 4, the FTC issued a request for information on noncompete agreements, seeking to “better understand the scope, prevalence, and effects of employer noncompete agreements, as well as to gather information to inform possible future enforcement actions.”
    • The public comment deadline is November 3, 2025.
  • Healthcare Dive informs us,
    • “The 340B drug discount program incentivizes hospitals to purchase outpatient clinics and prescribe more and higher-cost drugs — behaviors that tend to increase costs for the federal government and commercial health plans, according to a new report from the nonpartisan Congressional Budget Office.
    • “Only one-third of the sharp growth in 340B spending since 2010 is due to rising drug costs and higher prescribing of more expensive drugs, the CBO estimates. Instead, the growth has mostly been fueled by hospitals acquiring off-site clinics and contracting with more independent pharmacies, along with more providers becoming eligible for 340B.
    • “Though the CBO stressed it doesn’t have enough data to quantify the influence of each factor individually, the agency believes that the biggest driver of snowballing 340B growth is probably hospital-clinic M&A.”

From the Food and Drug Administration front,

  • BioPharma Dive tells us,
    • “Senior Food and Drug Administration official Vinay Prasad has reclaimed a role as the agency’s top doctor and scientist six weeks after his dramatic departure and one month after his surprising return to lead the regulator’s biologics medicine division.
    • “On the FDA’s website, Prasad, a physician and prolific researcher, is now listed as the agency’s chief medical and scientific officer in addition to his role as director of the Center for Biologics Evaluation and Research, or CBER. A spokesperson for the Department of Health and Human Services, the FDA’s parent agency, confirmed via email Prasad’s reappointment to his former role.
  • MedTech Dive adds,
    • “Patient groups called for substantial changes to medical device user fees in comments submitted to the Food and Drug Administration. Negotiations recently kicked off for the medical device user fee amendments, which will determine how much funding the FDA’s device center can collect from the industry in fiscal years 2028 through 2032.
    • “After a public hearing last month, clinicians and patient groups submitted comments calling for an increase to user fees, bolstering FDA staffing and more emphasis on product safety. They also called for greater transparency around negotiations and for patients to have more input on the final agreement. 
    • “The FDA received a total of 27 comments by Sept. 4, including several submissions from patients and medical groups. Two large medtech industry lobbying firms, Advamed and the Medical Device Manufacturers Association, which had opposed user fee hikes in the public hearing, had not posted comments as of Thursday.”
  • Beckers Hospital Review provides us with an update on State actions to expand access to the Covid vaccine.

From the public health and medical/Rx research front,

  • The New York Times reports,
    • “Chronic diseases like heart disease, cancer and diabetes are some of the leading causes of death around the world. A new global study shows that deaths from such “noncommunicable” conditions have been declining in most countries — but the pace of that decline, including in high-income countries like the United States, has slowed in recent years.
    • “The probability of dying from a chronic disease between birth and age 80 dropped in about 150 countries from 2010 to 2019, the study, published Wednesday in The Lancet, found. But compared to the previous decade, there was a widespread slowdown — in some cases, even a reversal — in progress.
    • “In the United States, the overall probability of dying from a chronic disease fell markedly between 2001 and 2010 but remained nearly flat over the following nine years. Among younger adults (20 to 45 years old), this probability increased — a rarity among high-income countries. The chance of dying specifically from neuropsychiatric conditions like Alzheimer’s disease and alcohol and drug use disorders also rose in the United States during this period.””
  • Cardiovascular Business notes,
    • “Diets that prioritize plant-based foods while limiting meat and dairy products are associated with reduced risks of all-cause mortality, cardiovascular disease (CVD), coronary heart disease, stroke and diabetes. 
    • “That was the primary takeaway from a new study of more than 3.4 million adults who participated in the National Health and Nutrition Examination Survey (NHANES), UK Biobank or one of 37 different clinical trials. The full analysis was published in Science Advances.” * * *
    • Click here to read the full study.
  • The Hill points out,
    • A DermaRite Industries hand soap recall has been expanded to more than 30 products, including deodorant, lotions, shampoo, hand sanitizer and more.
    • The recall was initiated in July and was expanded recently over concerns that more of its products may include Burkholderia cepacia complex. Exposure to the bacterium could “result in serious and life-threatening infections,” the company said in a release.”
    • “For healthy individuals with minor skin lesions, the use of the product may result in local infections, whereas in immunocompromised individuals the infection could spread into the blood stream, potentially leading to life-threatening sepsis,” the release noted.
    • “Symptoms of bacteria exposure include fever, fatigue and possible respiratory infections for patients with compromised immune systems, according to the Centers for Disease Control and Prevention (CDC).
    • “The products were distributed nationwide in the U.S., including Puerto Rico.”
  • The Wall Street Journal reports,
    • “More women are using cannabis during pregnancy, driven by fears about prescription drugs and beliefs it’s safe for conditions like nausea.
    • “Research on cannabis use during pregnancy is limited, but recent studies suggest potential risks to fetal brain development.
    • “Dispensary practices and conflicting advice from various sources add to confusion, highlighting the need for more research.”
  • BioPharma Dive relates,
    • “Capsida Biotherapeutics has suspended a recently begun clinical trial of an experimental gene therapy after the first participant in the study died following treatment.
    • “Capsida disclosed the death in a letter Wednesday to the patient community for the rare neurodevelopmental disease its gene therapy is designed to treat. In it, the biotechnology company noted it has informed the Food and Drug Administration and will soon provide regulators a full report of the patient’s death.
    • “We understand this devastating news will raise questions and uncertainty, and we are working with urgency to gather information and find answers,” Capsida wrote in its letter.”
  • Per Fierce Pharma,
    • “Approved 15 months ago as a pneumococcal disease vaccine for adults—and billed as the first shot designed for seniors—Merck’s Capvaxive now has data supporting its potential in children and adolescents.
    • “In a phase 3 study of 882 participants aged 2 through 17 who have completed a primary pediatric pneumococcal vaccination regimen and have one or more chronic medical conditions that put them at an increased risk of the respiratory disorder, Capvaxive made the grade in three key measures.”
  • Per Medscape
    • Pavani Chalasani, MD, MPH, is professor of medicine and director of the Division of Hematology/Oncology at The George Washington University. In this interview, Chalasani discusses how liquid biopsies are used to guide therapy in breast cancer and reviews the role of antibody-drug conjugates in current practice.

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “AbbVie has struck a deal with generic drugmakers aimed at extending patent protection for its blockbuster autoimmune drug Rinvoq well into the next decade.
    • “AbbVie on Thursday said it has settled litigation with all generic manufacturers that have filed applications with the Food and Drug Administration for generic versions of Rinvoq, which is approved for use in several autoimmune diseases.
    • “The North Chicago, Ill., biopharmaceutical company said it now doesn’t expect any U.S. generic entry for Rinvoq prior to April 2037, given the settlement and license agreements and assuming the company wins pediatric exclusivity.
    • “Analysts at William Blair, who had previously assumed a 2033 loss of U.S. patent exclusivity for Rinvoq, said the settlements are a big win for AbbVie that support longer-term protection for the franchise.”
  • STAT News reports,
    • “Consumers can now purchase Exact Sciences’ liquid biopsy early detection test, Cancerguard, and get an indication of whether they might have one of 50 different cancers included in the test’s analysis. The biotechnology company launched the test on Wednesday, and Tom Beer, Exact’s chief medical officer, relayed the news with elation.
    • “I am feeling fantastic. This is what I came to Exact to do,” Beer said. A practicing oncologist, Beer said that he’s reminded every Friday in clinic of the world of difference that catching cancer early can make. The promise of liquid biopsy tests is to do that for dozens of cancers, not just breast, prostate, colorectal, lung, and cervical cancer.”
  • Per Modern Healthcare,
    • “CVS Health has named Jon Thiboutot as president of retail health, effective immediately.
    • “Thiboutot was most recently vice president of operations at CVS MinuteClinic. He succeeds Dr. Creagh Milford, who had served as interim president of retail health since May and will continue to lead primary care provider Oak Street Health, CVS said Thursday.
    • “A CVS spokesperson declined to say whether the company will fill Thiboutot’s former role.”
  • and
    • “The American Medical Association released nearly 300 new Current Procedural Terminology billing codes Thursday as part of its proposed 2026 code set.
    • “Two other codes can be used to report remote monitoring treatment management after 10 minutes of services per calendar month, down from 20 minutes, according to an AMA news release. 
    • “Several augmented and artificial intelligence services were also included in the new code updates, ranging from tools that assess coronary disease to burn wound classification, according to the release. 
    • “The updates signal potential broader acceptance and reimbursement for digital health services in standard billing codes.
    • “The AMA’s CPT Editorial Panel organizes the association’s CPT code system, which is used in billing and reimbursement by the Centers for Medicare and Medicaid Services, as well as other payers and providers. CMS and others have the option to adopt the changes and put them into effect starting Jan. 1.” 
  • Beckers Hospital Review informs us
    • “The District of Columbia holds the highest ratio of nurses to population, to a significant degree, at 7.14 per 100 residents, while Utah has the lowest, at 1.38, according to a Becker’s analysis. [The full list is displayed in the article.]
    • “The analysis is based on U.S. Census Bureau state population estimates as of July 1, 2024, and active registered nurse and practical nurse license counts from the National Council of State Boards of Nursing database. The number of nurses per 100 residents was calculated by dividing the total number of active licenses in each state by its population and multiplying by 100. In California, the total reflects RN and vocational nurse licenses, rather than PN.”
  • and
    • “Landmark Hospital of Cape Girardeau (Mo.), a long-term acute care facility, has shared plans to close “in the coming weeks,” according to a Sept. 10 news release.
    • “The hospital has been open since early 2006 and is part of Cape Girardeau-based Landmark Holdings of Florida, which operates six long-term acute care hospitals across the U.S. The hospital operator sought Chapter 11 protection in early March and plans to find buyers for its facilities to relieve mounting financial challenges.”

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • “The Trump administration is calling on Congress to pass a four-month stopgap spending bill, in order to avoid a government shutdown, according to congressional appropriators.
    • “House Appropriations Committee Ranking Member Rosa DeLauro (D-Conn.) said in a statement Tuesday that the Trump administration is seeking a continuing resolution through Jan. 31, 2026.
    • “The administration is seeking a longer CR than some lawmakers previously considered. But the House and Senate aren’t close to getting 12 spending bills for fiscal 2026 through the normal appropriations process.”
  • The American Hospital Association adds,
    • “The House Appropriations Committee Sept. 9 advanced the fiscal year 2026 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies by a 35-28 vote. The bill provides a total discretionary allocation of $108 billion for HHS, representing roughly $7 billion or 6% below the FY 2025 enacted level. Within that total, the Health Resources and Services Administration was allocated $7.4 billion, marking an $880 million decrease. The agency was provided $1.3 billion for workforce initiatives, a $37 million decrease, and $515 million for rural health, marking a $150 million increase. 
    • “Additionally, the bill maintains funding for the Hospital Preparedness Program ($65 million), Children’s Hospitals Graduate Medical Education ($395 million), National Institutes of Health ($47 billion), as well as other key initiatives within the health care workforce, behavioral health and maternal and child health programs.”  
  • Roll Call informs us,
    • “Democrat James Walkinshaw won Tuesday’s special election for Virginia’s 11th District to fill the unexpired term of his former boss, the late Democratic Rep. Gerald E. Connolly.
    • “Walkinshaw, a Fairfax County supervisor, was leading Republican Stewart Whitson, an Army veteran and former FBI official, 75 percent to 25 percent, when The Associated Press called the race at 7:36 p.m. Eastern time. 
    • “Walkinshaw’s win was expected in the deep-blue Northern Virginia district, which encompasses the Washington, D.C., suburbs heavily populated by federal workers.” * * *
    • “Once Walkinshaw is sworn in, House Republicans will hold 219 seats to 213 for Democrats, with three vacancies that will be filled by upcoming special elections. 
    • “A special election in Arizona’s 7th District will take place later this month to elect a successor to the late Democratic Rep. Raúl M. Grijalva, who died in March from complications of his cancer treatment. There will also be special elections in Texas’ 18th District for the seat of the late Democratic Rep. Sylvester Turner and in Tennessee’s 7th District, where the Republican incumbent, Mark E. Green, resigned in July for a private sector job.”
  • The Wall Street Journal reports,
    • “U.S. population growth will slow to a crawl over the next few decades as fertility rates decline and net immigration shrinks because of stricter enforcement, the Congressional Budget Office said Wednesday. 
    • “Deaths are now projected to exceed births in 2031. Just eight months ago, CBO had projected that threshold wouldn’t be crossed until 2033.  
    • “By 2055, the U.S. population will be about 367 million, up from 350 million today. In January, CBO had projected a 2055 population of 372 million. From 1975 through 2024, U.S. population growth averaged 0.9% annually. By the early 2050s, according to the latest projections, population growth will effectively be zero.” 
  • Bloomberg Law tells us,
    • “The share of individuals in the US lacking health coverage held steady at 8%, or roughly 27 million people, in 2024, according to data the US Census Bureau released Tuesday.
    • “The data show fluctuations in the uninsured rate for different demographics, although the numbers were not considered statistically significant. Working-age Black Americans’ uninsured rate ticked up from 11.1% to 12.3%, while Hispanic Americans’ uninsured rate dipped from 23.6% to 23%. Foreign-born workers were more than twice as likely to lack health insurance as native-born workers.
    • “Coverage through public programs dropped 0.8 percentage points to 35.5%, driven by a 1.3 percentage point reduction in Medicaid enrollment. Medicaid coverage totaled 17.6% in 2024, while Medicare accounted for 19.1%.
    • “Private market coverage covered 66.1% of Americans, with 53.8% covered by their employer. Private coverage increased 0.7 percentage points, fueled by an increase in the individual market.
    • “The individual market covered 10.7% of Americans in 2024. Of that, the Affordable Care Act exchanges accounted for 4.3%.”
  • Modern Healthcare reports,
    • “A little over a month before the annual enrollment period, the Centers for Medicare and Medicaid Services is urging Medicare Advantage insurers to make significant changes to how they present their offerings to beneficiaries.
    • “Perhaps most notably, CMS will incorporate provider network lists into the Medicare Plan Finder tool enrollees use to select plans, it notified insurers last month. The agency is simultaneously developing a national provider directory that will not be ready in time for the 2026 Medicare Advantage and Part D sign-up campaign, which runs Oct. 15-Dec. 7.
    • “CMS also intends to add more details about Medicare Advantage supplemental benefits and a prescription drug pricing search tool powered by artificial intelligence.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million units of unauthorized e-cigarette products with an estimated retail value of $86.5 million – the largest-ever seizure of this kind. The seizures were part of a joint federal operation in Chicago to examine incoming shipments and prevent illegal e-cigarettes from entering the country.
    • “Almost all the illegal shipments uncovered by the operation originated in China. FDA and CBP personnel determined that many of these shipments contained vague and misleading product descriptions with incorrect values, in an apparent attempt to evade duties and the review of products for import safety concerns.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA is planning to call on the health-care industry and consumers to provide information on the benefits of switching a prescription drug to over-the-counter, the agency’s drug chief said Tuesday.
    • “What we want people to do is focus on the benefit that we can provide to society by that switch,” George Tidmarsh, director of the Center for Drug Evaluation and Research, said at a regulatory conference held by the Consumer Healthcare Products Association.
    • “I encourage industry to really focus, in the broadest way, on the benefit of the switch,” Tidmarsh added. “Not just the specifics of that, but the impact broadly in the health-care system.” 
    • “The agency will announce the request for information in the Federal Register, the drug chief said.
    • “Switching a prescription drug to over-the-counter is a highly regulated process that widens the range of medicines available to consumers.”
  • Per the AHA News,
    • “The Food and Drug Administration Sept. 10 released draft guidance on non-opioid treatments for treating chronic pain and reducing prescription opioid misuse. The guidance includes regulatory considerations regarding the categorization of multiple chronic pain conditions versus individual chronic pain indications; the design of clinical trials that ensure safety and efficacy; the evaluation of non-opioid drugs to avoid, reduce or eliminate opioid use; and the inclusion of statistical principles, patient-reported outcomes and use of expedited programs to support non-opioid drug development. The FDA is accepting comments on the guidance for 60 days following publication in the Federal Register.”
  • BioPharma Dive lets us know,
    • “The Food and Drug Administration on Tuesday approved a drug-device combination for bladder cancer that its developer, Johnson & Johnson, claims represents “a new, potentially practice-changing approach.”
    • “The treatment, which J&J will sell as Inlexzo, is a medical device that releases the chemotherapy gemcitabine into the bladder. It’s approved for use in people whose disease hasn’t yet spread but doesn’t respond or stopped responding to a commonly used immunotherapy. Historically, those patients have had have their bladders surgically removed.
    • “J&J executives have predicted Inlexzo will achieve blockbuster sales, and highlighted how the company’s internal sales estimates are more than three times higher than Wall Street’s predictions. “We really think that we’ve got a winner there,” Jennifer Taubert, the head of the company’s pharmaceuticals business, said on a conference call in July.”
  • Genetic Engineering and Biotechnology News adds,
    • “There are multiple different types of drugs available for the treatment of Alzheimer’s disease: cholinesterase inhibitors to treat symptoms from mild to severe, and disease-modifying immunotherapies to remove amyloid plaques and slow disease progression. In addition, vaccines that aim to clear the amyloid-beta plaques that accumulate in the brains of Alzheimer’s patients—or the neurofibrillary tangles formed by abnormal tau proteins—have been an area of active study.
    • “Now, a vaccine moves one step closer to approval. The Swedish biopharmaceutical company Alzinova recently announced that the FDA has approved the company’s Investigational New Drug (IND) application for its planned Phase II clinical study with the vaccine candidate ALZ-101 for Alzheimer’s disease. The company’s clinical development specializes in the treatment of Alzheimer’s disease, at the starting point of attacking toxic amyloid-beta oligomers.” * * *
    • “ALZ-101, a vaccine that stimulates the production of antibodies against the toxic Aβ oligomers, is Alzinova’s lead candidate. The company ran a first-in-human clinical study to evaluate the safety and immunogenicity of the oligomer-specific therapeutic vaccine ALZ-101 and released favorable data from part A of its Phase Ib clinical trial in November 2023.”

From the public health and medical/Rx research front,

  • ABC News reports,
    • “The United States death rate decreased by 3.8% in 2024 as COVID fell out of the top 10 leading causes of death for the first time in four years, new provisional federal data shows.
    • “The overall rate declined from 750.5 per 100,000 people in 2023 to 722 per 100,000, according to the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS).
    • “This marks the lowest death rate recorded since 2020, during the first full year of the COVID-19 pandemic and follows declines that began in 2022.
    • “The report also found that overall deaths fell from 3.09 million in 2023 to 3.07 million in 2024.
    • “Additionally, the report showed the three leading causes of death stayed the same from 2023 to 2024, with heart disease as the leading cause, followed by cancer and unintentional injury, respectively.
    • “‘It’s pretty noteworthy that COVID-19 fell off the top 10 and suicide, which had been had fallen off in recent years, is … ranked again,” Farida Ahmad, corresponding author of the report and health scientist at NCHS, told ABC News. “I think that’s a pretty interesting finding given where we spent the last five years.”
    • “Ahmad said fewer deaths from COVID in 2024 compared to 2023 may be a reason behind the 3.8% decline.”
  • STAT News points out,
    • “Many Americans take a dark view of nicotine. The stimulant, which occurs naturally in tobacco plants, is what makes cigarettes so addictive, with smoking responsible for 490,000 American deaths each year. When people try to quit smoking, it’s often cravings for nicotine, and the surge of dopamine it releases in the brain, that foil their attempts.
    • “In this sense, nicotine is responsible for many health problems. But public health experts say that while nicotine poses risks, some nicotine products are safer than cigarettes — and they worry popular misconceptions about the chemical’s effect on the body are doing more harm than good. 
    • “A majority of people in the U.S. wrongly believe that nicotine is the substance in cigarettes that causes cancer. In fact, “the harm from smoking comes from the burning of the ingredients in a cigarette, not from the nicotine itself,” said Jamie Hartmann-Boyce, a health policy researcher at the University of Massachusetts Amherst. More than 70 carcinogens have been identified in the cigarette smoke produced by the combustion of tobacco, which can damage people’s DNA and lay the groundwork for cancer.
    • “For many years, cigarettes were the main way that most Americans consumed nicotine. That meant it wasn’t a big problem from a public health perspective if people conflated the dangers of smoking with the dangers of that particular chemical, so long as that helped deter them from lighting up.
    • “Now, thanks to the more recent introductions of smoke-free options like e-cigarettes and nicotine pouches, “we are in a totally different landscape when it comes to commercial nicotine products,” Hartmann-Boyce said.”
  • The University of Minnesota’s CIDRAP notes,
    • “One more measles case has been reported in Wisconsin’s Oconto County measles outbreak. The new case raises the state’s total to 25. All 25 cases have been in unvaccinated individuals, and 2 people have required hospitalization.  
    • “The Centers for Disease Control and Prevention (CDC) has posted its weekly measles update, and 23 more cases have been recorded since last week, raising the national total to 1,454. There are two more outbreaks, raising the total number of outbreaks to 37. Eighty-six percent of cases reported this year are linked to outbreaks.”
  • and
    • “A new survey of more than 21,000 US adults shows that those who reported food insecurity had a 73% higher chance of reporting post–COVID-19 condition, or long COVID. 
    • “The study was published yesterday in JAMA Network Open and adds to a growing body of literature that links food insecurity with delayed or forgone medical care, worsened mental health, and racial disparities during the COVID-19 pandemic, the authors said. This is the first known study to link food insecurity to long COVID.”
  • Per MedPage Today,
    • “The American Academy of Family Physicians (AAFP) split with federal health officials and recommended that all U.S. adults get an updated COVID-19 vaccine for the upcoming respiratory virus season.
    • “In particular, people 65 years or older, those at increased risk for severe outcomes, and anyone who has never received a COVID-19 shot before should be prioritized for vaccination, AAFP said.
    • “The move follows recent recommendations from the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG), which broke with federal COVID-19 vaccine guidance for children and pregnant women.”
    • “History shows us that vaccines have eradicated diseases that were disabling and deadly in the past, and we can keep it that way, if we continue to vaccinate,” Margot Savoy, MD, the AAFP’s chief medical officer, said in a statement. “AAFP’s recommendations are closely aligned with other medical societies to ensure continuity for both patients and physicians.”
    • :Like the recent AAP guidance, AAFP says that all children ages 6 to 23 months should be vaccinated against COVID-19. For children and teens ages 2 to 18 years, clinicians should use a risk-based, single-dose approach, according to the new recommendations. The AAFP said it supports immunization access for any family wanting COVID-19 vaccination.
    • The AAFP also recommends that women who are pregnant at any stage or lactating should get a COVID-19 shot, in line with ACOG’s recent recommendations.
  • The Washington Post reports,
    • Persistent sleeplessness may be far worse than a passing annoyance — gradually unraveling memory and mental sharpness, according to new research.
    • A study published Wednesday in Neurology, the journal of the American Academy of Neurology, identifies a troubling link: Older people who have chronic insomnia appear more likely to experience accelerated aging of the brain. These changes are revealed in both cognitive tests and imaging scans showing the altered structure of the brain.
    • The research involved 2,750 cognitively healthy adults with an average age of 70. The participants, who were tracked on average for 5.6 years, underwent annual testing of executive functioning, visual-spatial reasoning and other dimensions of cognition.
  • Per Beckers Hospital Review,
    • “A study found that GLP-1 drugs are associated with a lower risk of fractures, including hip and osteoporotic fractures. 
    • “The research, led by scientists from China and published in Acta Diabetologica, analyzed more than 490,000 adverse event reports from the FDA’s Adverse Event Reporting System between 2004 and 2022. Of the reports, 99,000 involved GLP-1 receptor agonists. 
    • “The study found that compared to other diabetes medications, GLP-1 receptor agonists had the lowest reporting odds ratio of any fracture-related adverse events, at 0.44. 
    • “The trend surfaced across fracture types, including osteoporotic and hip fractures. Among individual GLP-1 receptor agonist drugs, albiglutide showed the most pronounced reduction in fracture risk, researchers said.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “U.S. businesses are facing the biggest health-insurance cost increases in at least 15 years, after already-steep boosts in recent years that have pushed the annual expense for family coverage high enough to equal the price of a small car.
    • “Costs for employer coverage are expected to surge about 9.5% in 2026, according to an estimate from Aon, while an employer survey by WTW suggested 9.2%. Both benefits-consulting firms’ projections, which were provided exclusively to The Wall Street Journal, would represent the fastest rate of increase since at least 2011, when the price tags for employer coverage were far lower than the recent average of roughly $25,500 for a family plan.
    • “Other employer surveys conducted this year have generated similar findings—sharp hikes in health-coverage spending for next year, on top of two years of significant increases.”
  • Modern Healthcare reports,
    • “Kaiser Permanente and Renown Health signed an agreement to form a joint venture to operate a health plan and ambulatory care services in Nevada. 
    • “As part of the deal, Kaiser would acquire a majority stake in Renown’s insurance arm, Hometown Health, which has more than 73,000 members. Kaiser plans to start offering health plan coverage in northern Nevada as Kaiser Permanente Nevada with an open enrollment period late next year, according to a Wednesday news release.
    • “Kaiser Permanente Nevada would also open ambulatory sites with Renown in the Reno, Nevada, area. 
    • “The deal is expected to close in early 2026, pending regulatory approval.
    • “If approved, the joint venture would mark Oakland, California-based Kaiser’s expansion into Nevada. Kaiser already has more than 12.6 million health plan members in eight states and Washington, D.C.”
  • and
    • “Dr. Craig Albanese, CEO of Duke University Health System, will step down from his role to become president of integrated care and coverage for Kaiser Permanente effective Sept. 29.”
  • STAT News tells us,
    • Lilly “has signed a collaboration agreement with Remedium Bio to develop gene therapies for obesity and type 2 diabetes, Remedium said yesterday.
    • “This is part of a movement by pharma companies to develop longer-lasting treatments for obesity, which they argue will be more attractive to patients than the current therapies that are injected once a week. Novo Nordisk, along with Wave Life Sciences and Arrowhead Pharmaceuticals, have been studying the potential of using RNA-interference to treat obesity.
    • “However, it’s not yet clear how feasible it would be to create a long-lasting treatment for obesity, much less one that is a one-time therapy. Some experts also fear an over-medicalized approach to addressing the issue of high obesity rates. (We wrote about all that in an earlier story here.)
  • Per MedTech Dive,
    • “Boston Scientific has agreed to buy Elutia’s two bioenvelope products for $88 million, the companies said Tuesday.
    • “The agreement will give Boston Scientific control of Elupro and Cangaroo, devices designed to promote wound healing to prevent complications after pacemaker or defibrillator implantation. 
    • “Elupro and Cangaroo compete with Medtronic’s TYRX. BTIG analysts said in a note to investors that they believe “the Elupro bioenvelope may offer clinical and handling advantages over TYRX.”
  • Per Fierce Healthcare,
    • “Oracle Health is using its data and technology muscle to move out ahead in the healthcare AI arms race.
    • “Electronic health record companies are moving quickly to integrate AI tools into their platforms as advances with agentic AI open up new opportunities to tackle clinical workflows along with revenue cycle, patient communications and even clinical trial recruitment.
    • “Oracle, which owns EHR company Cerner (now Oracle Health), touted its latest AI capabilities for providers and AI-powered EHR features Thursday morning during its Health and Life Sciences Summit in Orlando, Florida.
    • “The data and technology company is putting more focus on its AI, data and cloud capabilities as rival Epic is also ramping up its AI tech within its EHR while also extending its reach to payers, life sciences and medical device companies.”
  • Radiology Business adds,
    • “Experts are pushing for new generalist radiology artificial intelligence models that move beyond single tasks and consolidate image interpretation assistance into one total package. 
    • “Scientists made their case in an editorial published Tuesday by Radiology, noting that narrow AI solutions suffer from financial limitations such as unsustainable price scaling and market fragmentation. Generalist AI could address these and other clinical and operational challenges, producing comprehensive reports that reduce radiologist effort and “unlock new value propositions.” 
    • “Recent advancements such as foundational models—trained on diverse datasets and adaptable to a wide range of downstream tasks with minimal training—pave the way for this method.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • The Wall Street Journal reports,
    • “The clock is ticking on core federal cybersecurity legislation set to expire Sept. 30, as a divided Congress and a looming government shutdown threaten progress on a new bill that seeks to extend provisions encouraging cooperation in fighting hackers. 
    • “The decade-old Cybersecurity Information Sharing Act, or CISA, set the legal framework aimed at protecting companies that voluntarily share cyber threat intelligence with other businesses and the federal government, shielding them from antitrust and liability charges.
    • “Sunsetting the legislation risks weakening cybersecurity defenses, in both business and government, by discouraging information-sharing about hacking tactics and other cyberattacks, cybersecurity experts said.” * * *
    • “On Wednesday [September 3, 2025], the House Homeland Security Committee unanimously approved a revised version of CISA, renaming it the Widespread Information Management for the Welfare of Infrastructure and Government Act, or Wimwag.
    • “The proposed bill, which would extend the legislation until 2035, includes updated language to reflect new hacking tactics, while boosting privacy and liability protections for companies, among other changes.
    • “Democrats had called for an extension of the 2015 law while leaving any changes to be considered after the September deadline. “More improvements will be necessary as the legislative process moves forward,” based on input by cybersecurity experts, Rep. Bennie Thompson (D., Miss.) told the committee.
    • “The bill now moves to the full House for consideration.”
  • On Thursday, the federal government’s Spring 2025 semi-annual regulatory and de-regulatory agenda was posted on reginfo.gov. Of note, the Department of Health and Human Services is projecting promulgation of an amended HIPAA Security Rule in May 2026.
  • The American Hospital Association News tells us,
    • The Cybersecurity and Infrastructure Security Agency, National Security Agency and international agencies Sept. 3 released joint guidance outlining a “software bill of materials” for organizations to strengthen cybersecurity, reduce risk and decrease costs. An SBOM is a list of all components contained in a software product. 
    • “Whether it’s an application used on a computer or the software that runs a medical device, most software incorporates components to accomplish specific tasks,” said Scott Gee, AHA deputy national advisor of cybersecurity and risk. “It is critical to understand what components are used in a piece of software because if a flaw is discovered in any, it could make the entire piece of software — and the organization’s network— vulnerable to attack. A good analogy is the ingredients list on food packaging — it tells consumers exactly what additives and preservatives are in their food. Without an SBOM, an organization would have no way to determine that the vulnerable component was present in their systems.” 
    • Gee also highlighted the importance of automated monitoring of SBOMs, as they would alert of any vulnerabilities that would require patching and remediation. 
       
  • Federal News Network informs us,
    • “The Cybersecurity and Infrastructure Security Agency has named a new top cyber official. Nick Anderson is now serving as executive assistant director of CISA’s cybersecurity division. Anderson is a Marine Corps veteran who previously led the Energy Department’s top cyber office during the first Trump administration. He most recently was president and chief operating officer of Invictus International Consulting. Anderson also was chief information security officer for Lumen Technologies Public Sector.”

From the cybersecurity vulnerabilities and breaches front,

  • CISA added seven known exploited vulnerabilities to its catalog this week.
    • September 2, 2025
      • CVE-2020-24363 TP-link TL-WA855RE Missing Authentication for Critical Function Vulnerability
      • CVE-2025-55177 Meta Platforms WhatsApp Incorrect Authorization Vulnerability
        • Security Affairs discusses these KVEs here.
    • September 3, 2025
      • CVE-2023-50224 TP-Link TL-WR841N Authentication Bypass by Spoofing Vulnerability
      • CVE-2025-9377 TP-Link Archer C7(EU) and TL-WR841N/ND(MS) OS Command Injection Vulnerability
        • Security Affairs discusses these KVEs here.
    • September 5, 2025
      • CVE-2025-38352 Linux Kernel Time-of-Check Time-of-Use (TOCTOU) Race Condition Vulnerability
      • CVE-2025-48543 Android Runtime Unspecified Vulnerability
      • CVE-2025-53690 Sitecore Multiple Products Deserialization of Untrusted Data Vulnerability
        • Cybersecurity Dive discusses the Sitecore KVE here.
        • Security Week discusses the other two KVEs here.
  • Cybersecurity Dive reports,
    • “In separate disclosures, Cloudflare Inc. and Proofpoint Inc. on Tuesday said they were impacted by the August supply chain attacks linked to Salesloft Drift. 
    • “The disclosures mark the latest in a wave of attacks, where a threat actor used compromised credentials linked to the Salesloft Drift AI chatbot to gain access to the Salesforce instances at hundreds of companies. 
    • ‘Cloudflare said it was notified last week of the incident, in which an outside attacker gained access to the text fields of support cases in its Salesforce instances, according to a blog post released Tuesday.
    • “Despite being part of a much larger supply chain attack, the company took full responsibility for the breach and issued an apology. 
    • “We are responsible for the tools we use in support of our business,” company executives said in the blog post. “For that, we sincerely apologize.”
    • ‘The incidents follow disclosures by Palo Alto Networks and Zscaler of their customer Salesforce environments being impacted by the supply chain attack.” 
  • Dark Reading relates,
    • “In a blog post Thursday, SecurityBridge said it discovered an exploit for CVE-2025-42957 and confirmed it has been used in the wild. “While widespread exploitation has not yet been reported, SecurityBridge has verified actual abuse of this vulnerability,” the blog post said. “That means attackers already know how to use it – leaving unpatched SAP systems exposed.”
    • “SecurityBridge added that SAP’s patch for CVE-2025-42957 is “relatively easy” to reverse engineer, and that successful exploitation gives attackers access to the operating system and all data in the targeted SAP system.” * * *
    • “Even though an attacker would need a valid user account to exploit CVE-2025-42957, SecurityBridge said the vulnerability was “especially dangerous.” * * *
    • “SecurityBridge urged customers to immediately apply the patch for CVE-2025-42957, which was released in SAP’s August 2025 security updates. To defend against potential exploitation, the company recommended implementing SAP’s Unified Connectivity framework (UCON) to restrict RFC usage, and to monitor logs for suspicious RFC calls and newly created admin accounts.
    • “The exploitation of CVE-2025-42957 follows attacks in the spring on a critical SAP NetWeaver zero-day flaw tracked as CVE-2025-31324. The vulnerability came under subsequent waves of attacks in the weeks following its initial disclosure in late April.”
  • and
    • “A young malware-as-a-service (MaaS) operation has been outed, shortly after the debut of its newest custom remote access Trojans (RATs).
    • “In recent weeks, researchers have been slowly, independently piecing together an emerging cybercrime threat cluster. First, they found a malware loader that had been spread hundreds of times and named it “CastleLoader.” Then, they uncovered the broader MaaS service around it, and called it “CastleBot.” Now, they’ve mapped out the infrastructure propping it all up, and identified new variants of its own Trojan, called “CastleRAT” (aka “NightShadeC2“), which various MaaS customers have distributed to victims via boobytrapped GitHub repositories, the ClickFix tactic, malicious websites advertising fake software, and other methods.”
    • “Plenty of questions still remain though, about the group that Recorded Future’s Insikt Group has labeled “TAG-150.” For instance, how has it managed to spread itself so far while maintaining essentially no visible presence on the Dark Web?”
  • Bleeping Computer points out “six browser-based attacks all security teams should be ready for in 2025.

From the ransomware front,

  • Industrial Cyber informs us,
    • “New data from Comparitech shows that of the 18 confirmed ransomware attacks in August, three hit manufacturers, two targeted healthcare companies, and another two struck the food and beverage sector. Overall, worldwide ransomware attacks rose from 473 in July to 506 in August, a 7% increase and the second consecutive month of growth after a decline from March through June 2025. While government systems remain a steady target, manufacturing recorded the sharpest rise, with attack claims surging 57% from 72 in July to 113 in August. Four of these incidents have been confirmed.
    • “August saw a first-of-a-kind attack on the state of Nevada. While hundreds of U.S. government organizations have suffered ransomware attacks, this is the first-ever statewide attack. The attack was first detected on August 24, 2025, and has left many citizens and state agencies without access to essential services. No hackers have claimed the attack as of yet, but if a ransom isn’t paid, it’s likely the group will come forward in the coming days/weeks.
    • “Comparitech reported that the healthcare and education sectors each recorded one confirmed attack in August, though both reported more unconfirmed attack claims compared with July. These numbers are expected to rise as additional incidents are confirmed in the coming weeks.”
  • BitDefender alerts us,
    • “Ransomware groups continue to evolve their tactics, but few have made as sharp an impact in 2025 as SafePay. Once a lesser-known player, the group has surged into prominence by quietly amassing hundreds of victims across the globe. In June, SafePay topped Bitdefender’s Threat Debrief rankings after claiming 73 victim organizations in a single month, and the group followed up with 42 more victims in July—its second-highest monthly tally to date. 
    • “With more than 270 claimed victims so far this year, SafePay’s discreet operations, rejection of the ransomware-as-a-service (RaaS) model, and rapid-fire victim disclosures signal a significant threat that security researchers and teams should understand.”
  • CIO explains why “the latest research into cybercrime and those behind it illustrates why businesses must quickly adapt to the rising tide of high-stakes cyber extortion.”
  • SC Media discusses “how AI has changed ransomware negotiations.”

From the cybersecurity defenses and business front,

  • Cybersecurity Dive reports,
    • “The cyber insurance market is continuing to stall with organic growth slowing and rates declining, according to a report Wednesday from global insurance firm Swiss Re. 
    • “Increased competition among insurers has led to a third consecutive year of reduced rates, according to the report, as the available supply of cyber coverage has exceeded current demand. The market imbalances have forced insurers to make concessions on premiums, cybersecurity controls and coverage limits. 
    • “The insurance industry has grown increasingly concerned in recent years about systemic loss events and the risk of liability over data privacy. That has led to worries over whether additional premium cuts are sustainable.” 
  • Cybersecurity Dive also explains how Tampa General Hospital’s “CIO and CISO teamed up to translate security decisions into dollars and cents.”
  • HIPAA Journal notes,
    • “Healthcare organizations are relatively unlikely to have serious cybersecurity vulnerabilities compared to other industry sectors, as they are generally good at prevention; however, when vulnerabilities are identified, healthcare lags other sectors when it comes to remediation. These are the findings from a recent analysis of penetration testing data and a survey of 500 U.S. security leaders by the Pentest-as-a-service (PTaaS) firm Cobalt. The findings are published in its State of Pentesting in Healthcare 2025 report.”
  • The Wall Street Journal adds,
    • “A study at UCSD Health found cybersecurity training had little effect on employees’ susceptibility to simulated phishing attacks.
    • “On average, four groups of employees who received training designed by the researchers had only a 1.7% lower failure rate than employees who had no training.
    • “Employees often didn’t engage with training, spending less than a minute on training pages over 75% of the time.”
  • Per Cyberscoop,
    • “Israeli cybersecurity company Cato Networks has acquired AI security startup Aim Security in its first ever acquisition, reflecting the broader industry rush to address security challenges posed by artificial intelligence adoption.
    • “The deal combines Cato’s Secure Access Service Edge (SASE) networking platform with Aim’s AI security capabilities, allowing the company to protect customers from threats associated with generative AI tools and applications. Financial terms were not disclosed. 
    • “The acquisition underscores how cybersecurity companies are scrambling to develop solutions for AI-related risks as enterprises rapidly adopt AI tools without fully understanding potential vulnerabilities. Aim’s technology addresses three key areas: securing employee use of public AI applications, protecting private AI systems, and managing security throughout AI development lifecycles.”
  • and
    • “Varonis has acquired SlashNext, an AI-driven email security company, for up to $150 million in a move that reflects the rising role of artificial intelligence in both attack and defense.
    • “The acquisition, announced Tuesday, brings together Varonis’ focus on data-centric security and threat detection with SlashNext’s technology for blocking phishing and social engineering attacks across email and collaboration platforms. The companies cited a rapidly evolving threat environment, as cybercriminals increasingly use AI to target victims on channels reaching beyond traditional email, including Slack, Microsoft Teams, WhatsApp, and Zoom.
    • “Founded by Atif Mushtaq, who worked on FireEye’s malware detection systems, SlashNext deploys predictive AI models to identify, remove and block socially engineered threats. Its technology leverages computer vision, natural language processing, and virtual browsers to pinpoint signs of compromise.”
  • Here’s a link to Dark Reading’s CISO Corner.

Cybersecurity Dive

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Per a Congressional news release,
    • “U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Maggie Hassan (D-NH) requested information from Aflac following a recent cyberattack on their internal data systems.
    • “This comes amid increasing cyberattacks on the health care sector. In 2024, there were over 700 large data breaches that impacted approximately 276 million Americans. These attacks not only threaten Americans’ sensitive health data, but delay lifesaving care to patients.
    • “The recent cybersecurity incident affecting Aflac’s supplemental insurance systems highlights the continuing risk to patients and other stakeholders,” wrote the senators. “While Aflac has stated that it ‘stopped the intrusion within hours,’ additional transparency is needed about whether the intruders accessed private consumer and patient data, how Aflac safeguarded protected health information (PHI) prior to the incident, and steps that the company intends to take going forward.”
  • Per a National Institute of Standards and Technology news release,
    • “A revision to NIST’s catalog of security and privacy safeguards [(NIST SP 800-53)] aims to help organizations better manage risks related to software updates and patches. 
    • “The catalog revision is part of NIST’s response to a recent executive order on strengthening the nation’s cybersecurity.
    • “Completed with the help of a real-time commenting system, the revision is available in several different formats, some of which are machine-readable.”
  • Dark Reading tells us,
    • “Updated federal agency guidelines for software bills of materials (SBOM) were recently released by the US Cybersecurity and Infrastructure Security Agency (CISA) with rules intended to push for additional transparency among software and component vendors. Experts agree the new rules are a hopeful step forward but worry they overlook some serious issues facing today’s software supply chain. 
    • “Since 2021, when the federal minimum SBOM guidelines initially were released, the idea has been debated in information security circles as a great concept, but just not feasible in the real world. Vendors pushed back, arguing that the regulations are onerous. And in the ensuing years, with federal agencies leading the way, SBOMs have been embraced to varying degrees. The SBOM challenge has been connecting the gorge between the information they provide, and the ability for cyber teams operationalize it. 
    • “CISA recently released its 2025 update to SBOM guidelines for federal agencies, and while experts say they are hopeful things are headed in the right direction, they also acknowledge skepticism across the cybersecurity industry about some aspects of the new guidance.” 
  • Per a CISA news release on August 26,
    • “Today, the Cybersecurity and Infrastructure Security Agency (CISA) released the Software Acquisition Guide: Supplier Response Web Tool, a no-cost, interactive resource designed to empower information technology (IT) and industry decision makers, procurement professionals and software suppliers strengthen cybersecurity practices throughout the software procurement lifecycle.
    • “The Web Tool builds on the “Software Acquisition Guide for Government Enterprise Consumers: Software Assurance in the Cyber-Supply Chain Risk Management (C-SCRM) Lifecycle”, offering a streamlined, digital experience that simplifies how users assess software assurance and supplier risk.
    • “This tool demonstrates CISA’s commitment to offering practical, free solutions for smarter, more secure software procurement,” said CISA Director of Public Affairs, Marci McCarthy. “Transforming the Software Acquisition Guide into an interactive format simplifies integrating cybersecurity into every step of procurement.”
  • Per Cyberscoop,
    • “The Treasury Department on Wednesday [August 27] expanded efforts to disrupt the pervasive North Korean technical worker scheme by imposing sanctions on people and organizations serving as facilitators and fronts for the country’s years-long conspiracy effort to defraud businesses and earn money despite international sanctions. 
    • “Vitaly Sergeyevich Andreyev, Kim Ung Sun, Shenyang Geumpungri Network Technology and Korea Sinjin Trading Corp. were all sanctioned by the Treasury Department’s Office of Foreign Assets Control for their alleged roles in the scheme orchestrated by the North Korean government.”

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive reports,
    • “Chinese government-backed hackers are targeting critical infrastructure and government computer systems as part of a yearslong campaign that includes the well-known Salt Typhoon activity, the U.S. and 12 other countries said on Wednesday.
    • “The data stolen through this activity against foreign telecommunications and Internet service providers (ISPs), as well as intrusions in the lodging and transportation sectors, ultimately can provide Chinese intelligence services with the capability to identify and track their targets’ communications and movements around the world,” the allied governments said in a joint advisory.
    • “The China-linked campaign has penetrated organizations in more than 80 countries, including more than 200 targets in the U.S., an FBI spokesperson told Cybersecurity Dive.
    • The advisory describes the attackers’ techniques, from initial access to data exfiltration; describes an incident in which the hackers tried to decrypt network traffic to collect administrator credentials; suggests strategies for threat hunting; and recommends mitigation activities.
  • and
    • “Hackers stole user credentials from Salesforce customers in a widespread campaign earlier this month, according to researchers at Google Threat Intelligence Group, who warned that the thefts could lead to follow-up attacks.
    • “A threat actor that Google tracks as UNC6395 targeted Salesforce instances using compromised OAuth tokens that were associated with the customer engagement vendor Salesloft’s Drift AI chat agent.
    • “Researchers believe the hackers’ primary goal was to harvest credentials, as they stole large amounts of data from numerous Salesforce instances.
    • “Google’s Threat Intelligence Group “is aware of over 700 potentially impacted organizations,” Austin Larsen, a principal threat analyst at the company, told Cybersecurity Dive in a statement. “The threat actor used a Python tool to automate the data theft process for each organization that was targeted.”
    • “The attacks did not involve any vulnerability in the Salesforce platform, according to researchers. After stealing the data, the hackers looked for sensitive credentials, including access keys and passwords for Amazon Web Services as well as access tokens for the Snowflake cloud platform. 
    • “The attacks largely occurred between Aug. 8 and Aug. 18, researchers said. By Aug. 20, Salesloft had begun working with Salesforce to revoke all active access and refresh Drift tokens, according to Google.”
  • Bleeping Computer adds,
    • “Consumer credit reporting giant TransUnion warns it suffered a data breach exposing the personal information of over 4.4 million people in the United States, with BleepingComputer learning the data was stolen from its Salesforce account.
    • “TransUnion is one of the three major credit bureaus in the United States, alongside Equifax and Experian. It operates in 30 countries, employs 13,000 staff, and has an annual revenue of $3 billion.”
  • Per Security Week,
    • “Multiple phishing campaigns deploying ConnectWise ScreenConnect for remote control demonstrate the sophistication, extent, and danger of AI-supercharged social engineering.
    • “An ongoing ScreenConnect threat example highlights primary aspects of modern cybercriminality: AI-enhanced, scaled, and sophisticated social engineering; use of trust and stealth to deceive security controls; and maximum use of the professionalized crime-as-a-service (CaaS) ecosphere.
    • “Current ScreenConnect campaigns differ in their attack details, but all conform to the basic process: a phishing attack leading to deployment of ScreenConnect to allow remote access and potential control of the victim organization. Researchers have found more than 900 targeted enterprises around the world.”
  • CISA added five known exploited vulnerabilities to its catalog this week.
    • August 25, 2025
      • CVE-2024-8069 Citrix Session Recording Deserialization of Untrusted Data Vulnerability
      • CVE-2024-8068 Citrix Session Recording Improper Privilege Management Vulnerability
      • CVE-2025-48384 Git Link Following Vulnerability
        • Cyber Press discusses these KVEs here.
        • Cybersecurity Dive adds more details on the Citrix KVEs here.
        • Bleeping Computer adds more details on the Git Link KVE here.
    • August 26, 2025
      • CVE-2025-7775 Citrix NetScaler Memory Overflow Vulnerability
        • Bleeping Computer discusses this KVE here.
    • August 29, 2025
      • CVE-2025-57819 Sangoma FreePBX Authentication Bypass Vulnerability
        • Bleeping Computer discusses this KVE here.

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Federal and state authorities are investigating a ransomware attack that has disrupted key services across the state of Nevada.
    • “The Sunday [August 24] attack interrupted multiple government services, including phone systems and state agency websites. 
    • “The attackers were able to exfiltrate data during the intrusion, but officials still don’t know what they took, Tim Galluzi, Nevada chief information officer and executive director of the Governor’s Technology Office, said during a press conference Wednesday.
    • “The process of analyzing the information to determine exactly what was taken is complex, methodical and time consuming,” Galluzi said, adding that it would be reckless to speculate on the nature of the stolen information.
    • “The Cybersecurity and Infrastructure Security Agency (CISA) and the FBI are helping Nevada officials respond to the intrusion. In a statement Wednesday [August 27], CISA said its threat hunters are helping analyze Nevada’s computer networks and mitigate any potential impact from the hack.
  • Security Week adds on August 29,
    • “Four days after the hackers hit the state’s network, certain state offices have resumed working with the public, some Nevada state’s departments have reverted to pen and paper operations to serve the public, and the Nevada Health Authority has restored some of its operations, including Medicaid and the benefits program.
    • “However, the Access Nevada application portal remains inaccessible, certain phone lines are down, the Child Care & Development Program cannot access case files or certifications, and DMV offices were closed on Wednesday, although its website has been restored.
    • “Emergency services and essential operations have remained available throughout the outage. Additional information can be found on this recovery status page.”
  • SpotlightPA reports,
    • “The Pennsylvania Office of Attorney General was the victim of a ransomware attack earlier this month, Spotlight PA has learned.
    • “The attack, first reported by the office on Aug. 11 as a “cyber incident,” has impaired many functions of the agency, as some staff and prosecutors remain unable to access archived emails, files, and internal systems crucial to pursuing cases on behalf of the commonwealth.
    • “The office confirmed the attack to Spotlight PA on Friday [August 29].
  • KERA News relates,
    • A cybersecurity breach in Greenville [,Texas] has affected the city’s ability to access police and other records.
    • The city’s servers were attacked by a ransomware group on Aug. 5.
    • “Upon identification, the City immediately implemented protective measures, isolated affected systems where appropriate, contacted law enforcement and engaged a third-party cybersecurity firm to mitigate the event and restore services,” the city said in a news release.
    • Greenville’s emergency 911 service was not affected and remains in operation, however, some phone lines may experience intermittent outages or busy signals, the city said.
  • Per Cyberscoop,
    • “A financially motivated threat group operating since 2021 has refined its technical tradecraft, honing its focus on cloud-based systems that allow it to expand ransomware operations beyond the scope of on-premises infrastructure, Microsoft Threat Intelligence said in a report released Wednesday [August 27].
    • “By leveraging cloud-native capabilities, Storm-0501 has exfiltrated large volumes of data with speed, destroying data and backups within victim environments and encrypted systems. “This is in contrast to threat actors who may have relied solely on malware deployed to endpoints,” Sherrod DeGrippo, director of threat intelligence strategy at Microsoft, said in an email.
    • “This evolution is about both a technical shift and a change in impact strategy,” DeGrippo said. “Instead of just encrypting files and demanding ransom for decryption, Storm-0501 now exfiltrates sensitive cloud data, destroys backups, and then extorts victims by threatening permanent data loss or exposure.”
    • “Storm-0501 targets opportunistically by searching for unmanaged devices and security gaps in hybrid cloud environments. By exploiting these vulnerabilities, it can evade detection, escalate its access privileges and sometimes move between user accounts. This approach amplifies the impact of its attacks and raises its chance for a payout, according to Microsoft.”
  • and
    • “Researchers at cybersecurity firm ESET claim to have identified the first piece of AI-powered ransomware in the wild.
    • “”The malware, called PromptLock, essentially functions as a hard-coded prompt injection attack on a large language model, causing the model to assist in carrying out a ransomware attack.
    • “Written in Golang programming code, the malware sends its requests through Ollama, an open-source API for interfacing with large language models, and a local version of an open-weights model (gpt-oss:20b) from OpenAI to execute tasks.
    • “Those tasks include inspecting local filesystems, exfiltrating files and encrypting data for Windows, Mac and Linux devices using SPECK 128-bit encryption.
    • “According to senior malware researcher Anton Cherepanov, the code was discovered Aug. 25 by ESET on VirusTotal, an online repository for malware analysis. Beyond knowing that it was uploaded somewhere in the U.S., he had no further details on its origins.
    • “Notably, attackers don’t need to deploy the entire gpt-oss-20b model within the compromised network,” he said. ”Instead, they can simply establish a tunnel or proxy from the affected network to a server running Ollama with the model.”
    • “ESET believes the code is likely a proof of concept, noting that functionality for a feature that destroys data appears unfinished. Notably, Cherepanov told CyberScoop that they have yet to see evidence of the malware being deployed by threat actors in ESET telemetry.”

From the cybersecurity defenses front,

  • Cyberscoop lets us know,
    • “Chief information security officers are increasingly concerned about the risk of a cyberattack, and a growing number say they have experienced a material loss of data over the past year, according to a report released Tuesday by Proofpoint. 
    • “Two-thirds of CISOs said their organizations have experienced a material loss of sensitive information over the past year, compared with only 46% in the prior year, according to the report. Meanwhile, three-quarters of CISOs fear they are at risk of a material cyberattack over the next 12 months.
    • “The increase reflects not only heightened risk but also a cultural shift among CISOs, according to Proofpoint.
    • “CISOs are becoming more transparent, especially in light of increased regulatory scrutiny and evolving board expectations,” Patrick Joyce, global resident CISO at Proofpoint, told Cybersecurity Dive.
    • “The annual “Voice of the CISO” report is based on a survey of 1,600 CISOs at organizations in 16 countries. The survey took place during the first quarter of 2025, and all respondents worked at organizations with more than 1,000 employees.”
  • Dark Reading offers ransomware defense tips here and cloud security tips here.
  • The Wall Street Journal reports,
    • “Cybersecurity concierge services offer tailored protection against online threats for high-profile individuals, including monitoring and data scrubbing.
    • “These services, costing from $1,000 to tens of thousands annually, attract those with substantial assets and a significant digital footprint.
    • “Demand is rising, with wealth managers for cyber protection, especially after experiencing breaches.”
  • Here is a link to Dark Reading’s CISO corner.