FEHBlog

Monday Report

David Ermer–Congress, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Huffington Post discusses OPM’s August 15, 2025, second addendum to its 2026 call letter for FEHB and PSHB benefit and rate proposals.
  • Bloomberg Law reports,
    • “Drugmakers are responding to President Donald Trump’s call to launch direct-to-consumer sales, sparking questions about how the strategy could upend the industry’s traditional players—or help preserve the status quo.
    • “Trump’s push for drugmakers to offer direct sales at the lowest price offered in other developed nations is stoking a burgeoning tactic by drugmakers aimed at ending rebates they pay to pharmacy benefit managers and health plans. But the strategy’s potential to lower patients’ costs is still unclear.
    • “Manufacturers are building a variety of direct-to-consumer pipelines that can either use patients’ insurance plans or bypass them in favor of cash payments. Industry observers say the range of options makes it hard to predict what the ultimate impact on insurers, pharmacy benefit managers, pharmacies, and wholesalers will be, and whether the new world benefits drugmakers more than consumers.
    • “It looks like they’re offering reduced prices, when, in fact, those prices are still unaffordable for people,” said Anna Kaltenboeck, president of Verdant Research and a former adviser to the Senate Finance Committee under ranking member Ron Wyden (D-Ore.).
    • “If drugmakers were serious about lowering costs for consumers, Kaltenboeck said, they could simply lower their prices across the board.
    • “This is yet another iteration of trying to avoid the conversation that we need to have about the way in which pharma companies set list prices in the United States,” she said.”
  • Reginfo.gov remains under maintenance at 6 pm ET today. P.S. At 8 am ET on Tuesday, reginfo.gov is back online but it’s displaying the Fall 2024 semi-annual regulatory agenda. So, there is more work to be done.
  • Per an HHS press release,
    • The U.S. Department of Health and Human Services (HHS) today launched MAHA in Action—a dynamic new platform showcasing the powerful federal initiatives and state-led reforms advancing President Donald J. Trump and Secretary Robert F. Kennedy, Jr.’s Make America Healthy Again (MAHA) agenda.
    • This interactive tool offers a clear, accessible window into the bold actions reshaping America’s food, health, and public safety systems. MAHA in Action is more than a tracker—it’s a public declaration of the profound changes already underway.
    • “Make America Healthy Again isn’t just a slogan—it’s a mission statement, and we’re delivering results, fast,” HHS Secretary Kennedy said. “The MAHA in Action tracker puts the wins on the map. It gives the public, the press, and policymakers real-time visibility into how we’re restoring health, integrity, and accountability to every corner of our public health agency.”
    • The MAHA in Action webpage features updates on federal reforms being implemented across HHS agencies, including removing petroleum-based dyes and harmful additives from the U.S. food supply, closing the GRAS loophole that allows chemicals into food often with unknown safety data, restoring public trust in vaccine safety and scientific transparency, and finding the root causes of the chronic disease epidemic including autism. * * *
    • “Explore the platform here and find out what changes are happening in your state.”
  • HCP Live tells us,
    • “On August 15, 2025, the US Food and Drug Administration (FDA) approved Tonix Pharmaceuticals’ TNX-102 SL, under the name Tonmya, for treating adults with fibromyalgia, the first new drug for the indication in more than 15 years.
    • “For many years, rheumatologists like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment needs for the majority of patients,” Philip Mease, MD, director of Rheumatology Research at the Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, said in a statement.1 “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”
    • “TNX-102 SL is a sublingual formulation of cyclobenzaprine and is also the first member of a new class of non-opioid analgesic drugs for fibromyalgia. Tonix originally announced the FDA’s acceptance of its new drug application for the medication in December 2024.

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about sodium consumption.
  • McKinsey and Company delves into “Closing the Black maternal-health gap: Healthier lives, stronger economies.”
  • The American Hospital Association News informs us,
    • “The Texas Department of State Health Services Aug. 18 announced that the state’s measles outbreak is over. The department said it had been more than 42 days since a new case was reported, surpassing the threshold to declare an end to an outbreak. There have been 762 confirmed measles cases during the West Texas-centered outbreak since late January. Of those, 99 individuals were hospitalized, and two school-aged children had died.”
    • “Nationwide, there have been 1,356 confirmed measles cases in 40 states this year, according to the latest Centers for Disease Control and Prevention data from Aug. 13. The vaccination status of 92% of all cases is classified as “unvaccinated or unknown.” 
  • Per a Senate news release,
    • “Today, 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 Texas Department of State Health Services formally declaring the end of the measles outbreak in West Texas. It has been more than 42 days since a new measles case was reported in any of the counties that previously had ongoing transmission.
    • “I commend the Texas Department of State Health Services and the Trump administration for their work to stop this measles outbreak, saving lives in Texas and beyond,” said Dr. Cassidy. “But this tragedy was entirely preventable, and work must continue to curb outbreaks in other states. Misinformation about the measles vaccine fueled the spread of this outbreak, killing three Americans and hospitalizing many more. No child in the United States should ever die of a vaccine-preventable disease.”
    • “The measles vaccine is effective, safe, and the best way to protect yourself and your family from contracting this deadly disease. I encourage every parent to vaccinate their child to prevent needless death in the future,” continued Dr. Cassidy.”
  • Amen to that statement.
  • The Wall Street Journal reports,
    • “Gwen Orilio didn’t know how long she had to live after her stage-four lung cancer diagnosis. The disease had already infiltrated her eye, so the 31-year-old didn’t bother opening a retirement account.
    • “Ten years later, Orilio is still alive. And she still has metastatic cancer. 
    • “Keeping her going is a string of new treatments that don’t cure the disease but can buy months—even years—of time, with the hope that once one drug stops working a new one will come along. Orilio started on chemotherapy, and then switched to a new treatment, and then another, and another, and another.
    • “What’s next? What do I have lined up for when this one stops working?” said Orilio, a high-school math teacher who lives in Garner, N.C. “My motto is that the science just needs to stay a step ahead of me, and so far it’s been working.” 
    • “This past winter, she started a retirement fund at age 41. 
    • “Orilio is part of a new era of cancer treatment challenging the idea of what it means to have and survive cancer. A small but growing population is living longer with incurable or advanced cancer, navigating the rest of their lives with a disease increasingly akin to a chronic illness. The trend, which started in breast cancer, has expanded to patients with melanoma, kidney cancer, lung cancer and others.”
  • NBC News relates,
    • “More children died from the flu this past season than any year outside of the swine flu pandemic in 2009. Most of them were unvaccinated. 
    • “That’s why some doctors are hoping that the first nasal flu vaccine available for use at home can improve vaccination rates among people, especially children, who are afraid of needles. 
    • “AstraZeneca’s FluMist Home, which was approved last fall, is now available with a prescription for children ages 2 and over, and adults up to age 49.” * * *
    • “FluMist Home is available only online. People ordering the nasal spray will need to complete a medical screening questionnaire at FluMist.com that is reviewed by a health care professional, according to the drugmaker. FluMist Home’s online pharmacy will then collect the insurance information and bill the health plan directly.”
  • BioPharma Dive points out,
    • “A small, New Jersey-based drug developer plans to push an experimental psychedelic compound into late-stage testing now that it’s scored positive results in a postpartum depression study.
    • “That study enrolled 84 women with moderate to severe postpartum depression, each of whom received a single injection of Reunion Neuroscience’s “RE104” and were then monitored for four weeks. Participants were split into two groups. One got the full, 30 mg dose of RE104, while the other got a far lower dose and served as an “active control” arm.
    • “According to Reunion, the trial achieved its main goal as the 30 mg group showed significantly greater reductions on a widely used depression scale where lower scores indicate less severe symptoms. Seven days after treatment, scores in the experimental arm had fallen by 23 points, versus 17.2 points in the active control arm.
    • “Reunion said researchers also saw “clinically meaningful” responses in the higher dose group that started the day they received their injections and lasted through the 28-day follow up. Just over 77% had scores that improved by 50% or more one week after treatment. In the control arm, 62% hit that milestone. Between the two groups, 71% of the former achieved “remission” of their depression symptoms at Day 7, compared to 41% in the latter.
    • “Reunion said its drug — which functions similar to psilocybin, a molecule found in some psychedelic mushroom species — was well tolerated by patients. There were no serious adverse events, nor was there any treatment-emergent treatment-emergent seizures or suicidal ideation or behavior.”

From the artificial intelligence front,

  • A journalist and mother writing in the N.Y. Times, calls attention to a material weakness in AI chatboxes.
    • “Most human therapists practice under a strict code of ethics that includes mandatory reporting rules as well as the idea that confidentiality has limits. These codes prioritize preventing suicide, homicide and abuse; in some states, psychologists who do not adhere to the ethical code can face disciplinary or legal consequences.
    • “In clinical settings, suicidal ideation like [the journalist’s late daughter Sophie expressed] typically interrupts a therapy session, triggering a checklist and a safety plan. Harry [the AI chatbox] suggested that Sophie have one. But could A.I. be programmed to force a user to complete a mandatory safety plan before proceeding with any further advice or “therapy”? Working with experts in suicidology, A.I. companies might find ways to better connect users to the right resources.
    • If Harry had been a flesh-and-blood therapist rather than a chatbot, he might have encouraged inpatient treatment or had Sophie involuntarily committed until she was in a safe place. We can’t know if that would have saved her. Perhaps fearing those possibilities, Sophie held her darkest thoughts back from her actual therapist. Talking to a robot — always available, never judgy — had fewer consequences.
    • “Harry didn’t kill Sophie, but A.I. catered to Sophie’s impulse to hide the worst, to pretend she was doing better than she was, to shield everyone from her full agony. (A spokeswoman for OpenAI, the company that built ChatGPT, said it was developing automated tools to more effectively detect and respond to a user experiencing mental or emotional distress. “We care deeply about the safety and well-being of people who use our technology,” she said.)”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Fierce Healthcare is honoring its 2025 Most Influential Minority Executives.
    • “This year, we’re recognizing 11 leaders who are leading the charge in pushing healthcare forward. They represent influence across sectors, from provider organizations to payers to digital health, and are critical voices both in the U.S. and globally.
  • Check it out.
  • MedCity Dive notes,
    • “GLP-1s have proven to be highly effective for obesity but are extremely expensive and often have serious side effects, such as nausea, vomiting, dizziness and fatigue.
    • “That’s why Noom, a digital weight loss company, has introduced microdosing for GLP-1s. The company’s program involves beginning with a very low dose and gradually increasing to no more than 25% of the standard maintenance dose, with the goal of finding the lowest effective amount that supports weight loss while minimizing side effects and reducing cost.” * * *
    • “Is this microdosing program safe and effective? Noom says that due to the smaller doses, patients reduce the risk and intensity of side effects. The company also provides clinical oversight to ensure safety.
    • “However, at least one obesity medicine specialist isn’t so convinced that Noom’s microdosing offering is safe. And the concern isn’t so much with the prescribing of smaller doses, but the use of compounded GLP-1s, as they are not FDA-approved.
    • “The microdosing itself is not necessarily an issue. … For example, for patients on Ozempic for diabetes, we would off-label do this once in a while, especially when patients had more gastrointestinal side effects or they were losing weight faster than they wanted. … What I sort of take issue with Noom is that, one, I don’t know what medication or even substance somebody’s pumping into their bodies. And then two, what are the actual doses? Or what are the actual equivalents [compared to branded GLP-1s]?” argued Dr. Disha Narang, an endocrinologist and director of obesity medicine at Endeavor Health.”
  • Fierce Healthcare lets us know,
    • “National pricing data show the cost of healthcare services varies greatly by payer, geography, setting and facility, presenting new fiduciary considerations for employers.
    • “Since 2022, health plans have been required to release machine-readable files disclosing negotiated rates of healthcare services with providers. Hospitals are also required to release the costs of shoppable services.
    • “Data analytics firm Trilliant Health ingested UnitedHealthcare and Aetna transparency files from February to April 2025 to create a new report. Now, those massive swaths of information are slowly becoming more actionable for employers, they will need to plan accordingly, said Chief Research Officer Allison Oakes in an interview with Fierce Healthcare.
    • “Because this pricing information wasn’t historically available, employers weren’t necessarily responsible for picking the highest value health plan for their employees,” she said. “This also shifts the onus and responsibility to employers to use the leverage they have in the market to start changing some of this pricing as well.”
  • CVS Health highlights its value-based program for behavioral health care through clinical collaboration.
    • “There is still a clear need for high-quality, evidence-based behavioral health care in the U.S.
    • “One way to get there is through innovative payment models, including value-based care (VBC) models.
    • “The value-based care arrangement between Aetna, a CVS Health company and health plan, and virtual eating disorder provider Equip is an example of success. Of the Aetna members treated by Equip since 2021, 86% have made progress in their eating disorder treatment and the average reduction in eating disorder symptoms is 70%, validated through the Eating Disorder Exam Questionnaire (EDE-Q).
  • Beckers Hospital Review identifies “seven new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • MedTech Dive tells us, “The Food and Drug Administration has authorized more medical devices that incorporate artificial intelligence. Keep track of the latest developments in this database” which MedTech Dive updated today.

Weekend update

David Ermer–ACA, Congress, FDA, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Congress remains on its State / District work break from Capitol Hill until September 2, 2025, roughly two more weeks.
  • The Office of Management and Budget’s reginfo.gov website remains under maintenance at 5 pm ET on Sunday.
  • STAT News reports,
    • “Novo Nordisk’s obesity drug Wegovy was cleared by U.S. regulators on Friday to treat an increasingly common liver disease, adding to the list of conditions for which the blockbuster therapy is now approved. 
    • “The Food and Drug Administration granted accelerated approval to Wegovy for patients with metabolic dysfunction-associated steatohepatitis, or MASH, with moderate to advanced liver scarring. The decision was based on Phase 3 results showing that the drug helped improve liver scarring, or fibrosis, and resolve symptoms.”

From the public health and medical research front,

  • Medscape reports,
    • “Heart disease is still the top cause of death in the US, but the types of heart disease killing people are changing, a new analysis has found. While deaths from acute conditions such as heart attacks have declined, deaths from other types of heart disease such as heart failure, hypertensive heart disease, and arrhythmias have increased.
    • “And that has important implications for primary care physicians (PCPs), who will shoulder much of the burden for caring for these patients who can survive acute threats such as a heart attack but go on to need care for chronic cardiac conditions, sometimes for decades.”
  • and
    • A significant [medical research] issue is under enrollment of women in randomized trials, meaning the percentage of women enrolled isn’t in line with the percentage of women with a particular disease in the real world — so signals that indicate an adverse event are not picked up. From a systems perspective, women do not clear drugs through their kidneys as quickly as men, and women maintain a higher blood concentration of the medication. “Women may be overmedicated,” Neurologist Irving Zucker and others wrote in a 2020 analysis of 86 medications.
    • “This can lead to adverse events (AEs). And they do.
    • “Women experience adverse drug reactions nearly twice as often as men, yet the role of sex as a biological factor in the generation of [these reactions] is poorly understood,” Zucker wrote in that study, published in the journal Biology of Sex Differences, which showed that pharmacokinetics “strongly linked” sex differences in adverse drug events.”

From the U.S. healthcare business front,

  • Beckers Payer Issues informs us,
    • “Mountain Health Co-Op, which insures more than 11,000 people in Wyoming, is exiting the state at the end of 2025, Cowboy State Daily reported Aug. 14. 
    • “Mountain Health CEO Blair Fjeseth told the news outlet that several factors contributed to the decision, but the high cost of healthcare was a top reason.” * * *
    • “The company was one of three insurers available on the ACA’s healthcare exchange in Wyoming, according to the report. 
    • “Mountain Health will continue to offer plans in Montana and Idaho, according to the report.” 
  • MedTech Dive lets us know,
    • “Philips said Thursday [August 14] that it will invest more than $150 million to expand manufacturing in the U.S. of AI-enabled technologies.
    • “The investment includes expanding manufacturing and research and development at a site in Reedsville, Pennsylvania, that makes AI-enabled ultrasound systems. The addition is expected to bring 24,000 more square feet of manufacturing space and 40,000 square feet of warehouse space. 
    • “Philips is making the investment as it expects growth in its ultrasound business and as the company works to optimize its manufacturing sites.“
  • HR Dive tells us,
    • “Regulatory requirements are combining with a cultural shift to push most U.S. companies in a recent WTW survey to adopt pay transparency practices, the consulting firm said in a press release Monday.
    • “WTW’s poll of 388 U.S.-based respondents found that 82% were either communicating, planning or considering communicating pay ranges with employees and 79% were doing so with external job candidates. However, fewer than half said they shared base pay determinations or progressions, and “even fewer” shared how pay ranges are designed or managed or shared the employee’s position within a given range.
    • “More than two-thirds of employers cited regulations as driving their pay transparency efforts, while 44% said the same of company values and culture and 41% pointed to employee expectations. These are signs of a “broader cultural shift” around communicating pay, Lindsay Wiggins, WTW’s North America pay equity co-leader, said in the release.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive tells us,
    • “The Trump administration should slash cybersecurity regulations and double down on winning the trust of the private sector, the U.S. tech industry’s largest trade group said in a paper published Tuesday [August 12, 2025].
    • “In a report laying out recommendations for the White House’s Office of the National Cyber Director — now helmed by newly confirmed Trump appointee Sean Cairncross — the Information Technology Industry Council said the government should focus on “results-driven action.”
    • “There is a need to prioritize impactful security outcomes, slash red tape, rethink legacy network architectures, invest in secure modern systems, and strengthen trusted partnerships between the public and private sectors,” ITI said.
    • “Achieving results, the group argued, “means empowering defenders with what they need to win: efficiency, appropriate resourcing, and the freedom to focus on real threats, not on navigating a web of regulatory regimes.”
  • Cyberscoop observes,
    • “Two executive orders President Donald Trump has signed in recent months could prove to have a more dramatic impact on cybersecurity than first thought, for better or for worse.
    • Overall, some of Trump’s executive orders have been more about sending a message than spurring lasting change, as there are limits to their powers. Specifically, some of the provisions of the two executive orders with cyber ramifications — one from March on state and local preparedness generally, and one from June explicitly on cybersecurity — are more puzzling to cyber experts than anything else, while others preserve policies of the prior administration which Trump has criticized in harsh terms. Yet others might fall short of the orders’ intentions, in practice.
    • But amid the flurry of personnel changes, budget cuts and other executive branch activity in the first half of 2025 under Trump, the full scope of the two cyber-related executive orders might have been somewhat overlooked. And the effects of some of those orders could soon begin coming to fruition as key top Trump cyber officials assume their posts.
  • Federal News Network reports,
    • “The Cybersecurity and Infrastructure Security Agency has rolled out new guidance to help deal with what some cyber experts say is a rising concern: a lack of visibility into threats to operational technology.
    • CISA on Wednesday [August 13, 2025] published “Foundations for OT Cybersecurity: Asset Inventory Guidance for Owners and Operators.” CISA developed the guidance in conjunction with other agencies, including the Environmental Protection Agency, the National Security Agency, the FBI and several international partners.
    • The guidance focuses on operational technology, which refers to hardware and software that monitor and control physical processes in industrial settings.
    • “OT systems are essential to the daily lives of all Americans and to national security,” Acting CISA Director Madhu Gottumukkala said in a press release. “They power everything from water systems and energy grids to manufacturing and transportation networks. As cyber threats continue to evolve, CISA through this guidance provides deeper visibility into OT assets as a critical first step in reducing risk and ensuring operational resilience.”
  • Federal News Network also interviews Steve Shirley, Executive director, National Defense Information Sharing and Analysis Center, and J.R. Williamson, “Vice president and chief information security officer, Leidos, about the evolution of zero trust. “Federal agencies are learning that implementing Zero Trust means more than deploying new tools. It requires rethinking how users, devices and data interact across every layer of the enterprise.”
  • The American Hospital Association News informs us,
    • “The Department of Justice Aug. 11 announced a series of actions taken against the BlackSuit ransomware group, also known as “Royal,” including the disruption of four servers and nine domains July 24. BlackSuit attacks have targeted health care and other critical infrastructure sectors, DOJ said. 
    • “There is no doubt that the private sector also contributed information to facilitate this disruption, once again highlighting the value of public private operational engagement,” said John Riggi, AHA national advisor for cybersecurity and risk. “The BlackSuit/Royal ransomware group is directly responsible for multiple disruptive attacks against hospitals and health systems, posing a direct risk to patient and community safety. We hope these aggressive law enforcement operations continue at a pace that will meaningfully degrade foreign cyber adversaries’ abilities to harm the American public.”  

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive reports,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) and Microsoft on Tuesday [August 12, 2025,] updated their mitigation guidance for a high-severity flaw in Exchange Server.
    • The flaw, tracked as CVE-2025-53786, could allow an attacker with administrative privileges for on-premises versions of Exchange to escalate privileges by exploiting vulnerable hybrid joined configurations, Microsoft and CISA said last week. 
    • In an update on Tuesday, CISA said it still saw no evidence of hackers exploiting the flaw, but it urged organizations to review Microsoft’s updated guidance on identifying Exchange Servers on a network and running the Microsoft Exchange Health Checker.
    • “In its updated security bulletin, Microsoft said an attacker could potentially escalate privileges from an on-premises server to a connected cloud environment without leaving an “easily detectable and auditable trace.” 
  • Bloomberg Law reports,
    • “Russian government hackers lurked in the records system of the US courts for years and stole sensitive documents that judges had ordered sealed from public view, according to two people familiar with the matter and a report seen by Bloomberg News.
    • “The attackers had access to what was supposed to be protected information for multiple years, the report on the breach shows. They gained access by exploiting stolen user credentials and a cybersecurity vulnerability in an outdated server used by the federal judiciary, according to the report, which says the hackers specifically searched for sealed records. 
    • “The report, which was reviewed in part by Bloomberg, doesn’t identify the attackers. But investigators found evidence that they were a Russian state-sponsored hacking group, according to the people, who spoke on condition that they not be named because they were not authorized to discuss the matter.
    • “It’s unclear exactly when the hackers first penetrated the system and when the courts became aware of the breach. Last fall, the judiciary hired a cybersecurity firm to help address it, said one of the people.” * * *
    • “The intrusion was previously reported by Politico, while the New York Times earlier reported that Russia was at least in part behind the cyberattack.
    • “The hackers targeted sealed documents in espionage and other sensitive cases, including ones involving fraud, money laundering and agents of foreign governments, Bloomberg Law reported on Tuesday [August 12, 2025]. Such records often include sensitive information that, in the wrong hands, could be used to compromise criminal and national security investigations, or to identify people who provide information to law enforcement.”
  • Per Cybersecurity Dive,
  • and
    • Virtually all companies have experienced some type of intrusion due to vulnerable code, application security firm Checkmarx said in a report released Thursday [August 14, 2025.
    • Nearly eight in 10 firms reported experiencing such breaches in 2023, but that figure climbed more than 90% last year and reached 98% this year.
    • At the same time, eight in 10 companies said they sometimes or often released software with code they knew was vulnerable, up from two-thirds in 2024. “This isn’t oversight,” Checkmarx said. “It’s strategy.”
  • CISA added five known exploited vulnerabilities to its catalog this week.
  • Per Bleeping Computer,
    • “Security researchers have created a new FIDO downgrade attack against Microsoft Entra ID that tricks users into authenticating with weaker login methods, making them susceptible to phishing and session hijacking.
    • “These weaker login channels are vulnerable to adversary-in-the-middle phishing attacks that employ tools like Evilginx, enabling attackers to snatch valid session cookies and hijack the accounts.
    • “Although the attack doesn’t prove a vulnerability in FIDO itself, it shows that the system can be bypassed, which is a crucial weakness.
    • “This is especially worrying considering the increased adoption of FIDO-based authentication in critical environments, a consequence of the technology being touted as extremely phishing-resistant.”
  • and
    • “Cisco is warning about a critical remote code execution (RCE) vulnerability in the RADIUS subsystem of its Secure Firewall Management Center (FMC) software.
    • “Cisco FCM is a management platform for the vendor’s Secure Firewall products, which provides a centralized web or SSH-based interface to allow administrators to configure, monitor, and update Cisco firewalls.
    • ‘RADIUS in FMC is an optional external authentication method that permits connecting to a Remote Authentication Dial-In User Service server instead of local accounts.”

From the ransomware front,

  • Halcyon informs us,
    • “Black Hat 2025 had plenty of shiny new toys and buzzword-heavy sessions, but the real story was hiding in plain sight. No ransomware track. No packed panel on the threat that has cost organizations billions and taken down some of the most secure environments on the planet. The only time it truly took center stage was when Mikko Hyppönen made it impossible to ignore. 
    • “For those paying attention, three truths stood out. Agentic AI will accelerate ransomware campaigns to speeds that will overwhelm unprepared defenders. Ransomware is the next stage in the evolution of malware, and it will only become more capable. Modern security stacks, no matter how mature or expensive, are still being bypassed with troubling ease.” 
  • Bleeping Computer adds,
    • Ransomware and infostealer threats are evolving faster than most organizations can adapt. While security teams have invested heavily in ransomware resilience, particularly through backup and recovery systems, Picus Security’s Blue Report 2025 shows that today’s most damaging attacks aren’t always about encryption.
    • Instead, both ransomware operators and infostealer campaigns often focus on credential theft, data exfiltration, and lateral movement, leveraging old-school stealth and persistence to achieve their objectives with minimal disruption.
    • The evolving adversary tactics are clearly visible when comparing the findings from the Blue Report 2025, based on over 160 million real-world attack simulations, and the Red Report 2025, which analyzes the latest trends in malware, threat actors, and exploitation techniques.
    • The overlap between the two reports reveals a clear and concerning signal: defenders are falling behind on detecting the very tactics that adversaries now favor the most.
  • InfoSecurity Magazine reports,
    • “An ongoing data extortion campaign targeting Salesforce customers could soon turn its attention to financial services firms, security experts have warned.
    • “The notorious ShinyHunters group has been blamed for a series of data breaches impacting big names in the fashion (LVMH, Chanel, Pandora, Adidas) and aviation (Qantas, Air France-KLM) sectors. These victims are typically targeted with vishing for logins to their Salesforce accounts and are sometimes also tricked into downloading a malicious app for similar purposes.”
  • Per Dark Reading,
    • “An emerging ransomware actor is using sophisticated techniques in the style of an advanced persistent threat group (APT) to target organizations with customized ransom demands, posing a significant risk to businesses.
    • “Charon is a new ransomware family (named for the ferryman from Greek mythology who carried souls across the River Styx to Hades); Trend Micro observed it being deployed in a targeted attack in the Middle East’s public sector and aviation industry — the first such record of Charon observed in the wild, according to new research from the firm.
    • “The ransomware leverages techniques such as DLL sideloading, process injection, and anti-EDR capabilities, which are typically the hallmark of advanced threat actors and — in this case — reminiscent of campaigns by the group Earth Baxia, according to a Trend Micro blog post published today.
    • “The attack chain leveraged a legitimate browser-related file, Edge.exe (originally named cookie_exporter.exe), to sideload a malicious msedge.dll (SWORDLDR), which subsequently deployed the Charon ransomware payload,” Trend Micro threat researchers wrote in the post.”
  • and
    • “Researchers spotted a new Crypto24 ransomware campaign that they say marks a “dangerous evolution” in the threat landscape.
    • “According to Trend Micro researchers, recent attacks by Crypto24 actors display a combination of advanced evasion techniques and custom tools that can disable EDR solutions — including Trend Micro’s own Vision One platform. Crypto24 was first spotted in 2024 but hadn’t made much of impact until recently, when it became the latest ransomware gang to bypass EDR platforms and security solutions.
    • Trend Micro’s report, published Thursday, details how Crypto24 has demonstrated a high level of skill that sets it apart from other ransomware gangs. For example, researchers noted how “Crypto24 actors deftly deploy a broad range of tools that include legitimate programs like PSExec and AnyDesk for remote access and lateral movement, as well as Google Drive for data exfiltration.
    • “More importantly, Crypto24’s successful deployment of a customized RealBlindingEDR (an open source tool for disabling security solutions) variant that neutralized our security controls shows their capability to maneuver around modern defenses,” the report said. “The threat actor’s customized version employs advanced evasion, likely via unknown vulnerable drivers, showcasing deep technical expertise and ongoing tool refinement.”

From the cybersecurity business and defenses front,

  • Cyberscoop names its Cyberscoop 50 award winners for 2025.
    • “The CyberScoop 50 Awards recognize those who have been honored for their work in protecting vital networks, information and critical infrastructure. Through their hard work, ingenuity, and creativity, they aim to fend off hackers, stay ahead of adversaries and protect American networks.”
  • HelpNet Security lets us know,
    • “Security leaders are rethinking their approach to cybersecurity as digital supply chains expand and generative AI becomes embedded in critical systems. A recent survey of 225 security leaders conducted by Emerald Research found that 68% are concerned about the risks posed by third-party software and components. While most say they are meeting regulatory requirements, 60% admit attackers are evolving too fast to maintain resilience.” * * *
    • “Penetration testing is no longer treated as a box to check. It has become a core element of enterprise security programs. Eighty-eight percent of security leaders now consider it vital. Over half say they use pentests to validate their own software. More than half also require third-party pentests before releasing software to customers.
    • “The survey found that 49% plan to use pentesting to identify software supply chain vulnerabilities, and 44% intend to use it to uncover insider threats. The practice is being integrated across the development life cycle and procurement workflows.
    • “Generative AI is emerging as a new and unpredictable risk. Sixty-six percent of respondents say GenAI helps attackers analyze data and evade defenses. More than half worry that AI can automate the entire attack lifecycle, and 62% are concerned that AI development tools may introduce hidden vulnerabilities into codebases.”
  • Dark Reading discusses cybersecurity budgeting here and here.
  • Following the Blackhat Conference, Dark Reading’s CISO Corner is back.

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, NIH, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor, who is a lawyer, posted his latest blog entry today. The post is titled “Building Momentum Through Legal Wins.”
  • STAT News reports,
    • “US Health Secretary Robert F. Kennedy Jr.’s regulatory roadmap shows the Trump administration plans to continue efforts scaling back on gender-affirming care, advancing its Make America Healthy Again agenda, and restructuring how it grapples with Covid-19 vaccines.
    • “The US government on Friday posted the semi-annual regulatory agenda that details planned rulemaking for the Department of Health and Human Services, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and other federal health agencies.
    • “The agenda was originally posted online Friday morning but later was removed and replaced with an “under maintenance” message. The Office of Management and Budget’s press office did not immediately respond to an email seeking comment.”
  • The reginfo.gov website on which the semi-annual regulatory agenda is posted still says “The system is under maintenance. It will be back shortly” at 6 pm ET.
  • OPM circulated a last minute 2026 benefit change via this carrier letter (Dropbox link).
    • “For Plan Year 2026, chemical and surgical modification of an individual’s sex traits through medical interventions (to include “gender transition” services) will no longer be covered under the FEHB or PSHB Programs. This exclusion expands upon Carrier Letter 2025-01a and applies regardless of age.”
    • The letter also describes exceptions to this rule.
  • The Hill informs us,
    • “By the end of 2025, the Trump administration likely will have shed around 300,000 workers, Office of Personnel Management Director Scott Kupor told Reuters on Thursday.
    • “The mass departures, which Kupor claimed were largely accounted for by voluntary buyouts rather than firings, would constitute a 12.5 percent reduction of the federal workforce from when President Trump was inaugurated in January.”
  • Federal News Network reports,
    • “The Office of Personnel Management has officially canceled this year’s version of the signature survey that assesses governmentwide satisfaction and engagement levels of federal employees.
    • “In a memo distributed to agency chief human capital officers on Friday afternoon, obtained by Federal News Network, OPM said after initially only delaying the survey, it has now fully scrapped plans to conduct the 2025 Federal Employee Viewpoint Survey.”
  • The American Hospital Association tells us,
    • “The Centers for Medicare & Medicaid Services Innovation Center Aug. 12 released an FAQ on the Wasteful and Inappropriate Service Reduction Model, a six-year technology-enabled prior authorization program pilot. CMS will partner with third-party entities to implement the program for a specified list of services delivered to patients with Original Medicare. The FAQs address patient rights, the coverage review process for beneficiaries and providers, safeguarding against inappropriate denials, protecting patient data and more. The model begins Jan. 1.”
  • and
    • “The Health Resources and Services Administration has awarded more than $15 million in grants to 58 rural health organizations for four-year projects as part of the Federal Office of Rural Health Policy’s Rural Health Care Services Outreach program. The awardees must use innovative, evidence-informed models to address health care needs unique to their communities that are designed to expand access to care and improve health outcomes. The projects will be conducted by a local network of partnering organizations that may include rural hospitals, community-based organizations, health departments, schools, health centers, rural health clinics, academic institutions and other local and state entities.  
  • NCQA, writing in LinkedIn, informs us,
    • “NCQA and The Praxis Project are collaborating on a perinatal measure development project to create, validate and implement an actionable set of measures that align health plans toward improving perinatal health. The project team is developing up to eight new measures for potential inclusion in HEDIS® (Healthcare Effectiveness Data and Information Set) and in other national accountability programs.
    • “Currently, the teams are seeking testing partners—health plans, health systems, state agencies, community-based organizations, Federally Qualified Health Centers, birth centers—to help evaluate the feasibility, validity, reliability and usability of the new measures through a learning network, beginning this fall.”

From the Food and Drug Administration front,

  • BioPharma Dive lets us know,
    • “The Food and Drug Administration granted full approval to a first-of-its-kind treatment for recurrent respiratory papillomatosis, a rare and potentially life-threatening condition caused by persistent HPV infections. Thursday’s clearance of Precigen’s Papzimeos, an immunotherapy that helps clear HPV-infected cells, was based on study results showing a little more than half of drug recipients didn’t need surgery within a year of therapy. Center for Biologics Evaluation and Research director Vinay Prasad, who rejoined the FDA this week, described the approval as proof “randomized trials are not always needed to approve medical products.”
  • Cardiology Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about ongoing safety issues with a series of cannulae used to vent the left side of the heat during cardiopulmonary bypass surgery procedures. The agency’s alert includes dozens of lots of Medtronic’s DLP Left Heart Vent Catheters with malleable bodies and vented connectors. 
    • “The FDA put this early alert in place after receiving multiple reports of the catheters “resisting shape retention when being bent.” The devices were specifically designed to be easy to bend, holding their shape in a way that helps clinicians work in safe, efficient manner. When the devices fail to retain their shape, however, it can cause delays in care while a replacement catheter is located. 
    • “If the issue is not identified prior to use and the clinician uses the cannula, it may lead to abrasion and perforation (cuts),” according to the FDA’s advisory. “Perforation of critical heart tissue may potentially lead to death if it is complicated, unnoticed or untreated.”
    • “This issue has been linked to three serious injuries as of July 28. No patient deaths have been reported.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is going up across the country. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota’s CIDRAP lets us know,
    • New survey data from the Centers for Disease Control and Prevention (CDC) shows that uptake of two vaccines routinely recommended for teens increased last year, while coverage with another recommended shot remained flat.
    • The data from the 2024 National Immunization Survey-Teen, published yesterday in Morbidity and Mortality Weekly Report, show that, among 16,325 US adolescents aged 13 to 17 years, coverage with more than one dose of the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine increased from 89.0% in 2023 to 91.3% in 2024. Coverage with one or more dose of the quadrivalent (four-strain) meningococcal conjugate vaccine (MenACWY) rose from 88.4% to 90.1%.
    • Coverage with one or more Tdap dose was 90% or higher in 39 states, while coverage with one or more MenACWY dose was 90% or higher in 30 states. The survey also found that coverage with other recommended and catch-up vaccines increased in 2024, including the meningococcal group B vaccine (up 4.5 percentage point among 17-year-olds); the measles, mumps, and rubella vaccine (a 1.3-percentage-point increase in 13- to 17-year-olds with 2 or more doses); and the hepatitis B vaccine (a 1.3-percentage-point increase in teens with 3 or more doses).
    • “These findings highlight progress in public health activities to improve vaccination coverage,” CDC researchers wrote.
    • “Human papillomavirus (HPV) vaccine coverage among teens remained unchanged for the third straight year, however, with 78.2% having received one or more doses and 62.9% reporting they were up to date with the HPV vaccine. Coverage with one or more HPV vaccine doses was 80% or higher in 26 states and the District of Columbia.”
  • MedPage Today relates,
    • “Genetic susceptibility accounts for 20% of ovarian cancer risk, and risk-reducing bilateral salpingectomy remains the gold standard for prevention.
    • “In this study, about 24% of patients with high-grade serous ovarian cancer had missed opportunities for risk-reducing surgery before cancer diagnosis.
    • “Among the women with a first-degree family history of ovarian cancer, 43.2% had mutations that increased susceptibility to ovarian cancer.”
  • and
    • “A BMJ guideline put patient risk into the equation for assessing the suitability of SGLT-2 inhibitors and GLP-1 receptor agonist drugs for type 2 diabetes.
    • “Their use in type 2 diabetes was only strongly recommended for people at higher risk of cardiovascular and kidney complications.
    • “Meanwhile, these costly medications continue to be used more and more in the U.S. for a variety of indications.”
  • The AHA News points out,
    • “The American Heart Association and American College of Cardiology Aug. 14 released new guidelines on high blood pressure prevention, suggesting earlier treatment can reduce the risk of cognitive decline and dementia, as well as cardiovascular disease, stroke and kidney disease. The new guidelines replace those issued in 2017 and include new or updated recommendations for medication options and managing high blood pressure before, during and after pregnancy. The guidelines also reinforce the importance of healthy lifestyle behaviors such as eating a nutritious diet, being physically active, and maintaining or achieving a healthy weight.”
  • Per an NIH news release,
    • “Scientists at the National Institutes of Health (NIH) successfully reduced the severity of late-onset Tay-Sachs (LOTS) disease in human cell cultures and a mouse model by using a novel gene-editing treatment. LOTS is a rare form of Tay-Sachs disease, with signs and symptoms such as muscle weakness, loss of coordination, muscle spasms, and sometimes loss of mental function beginning in late childhood to adulthood. Similar disorders for which this breakthrough has implications include GM1 gangliosidosis, Sandhoff disease, Niemann-Pick disease, Krabbe disease and Gaucher disease.
    • “LOTS is a genetic disorder caused by a mutation in the HEXA gene that causes a deficiency of an enzyme that is critical to breaking down a fatty substance in the brain, known as GM2 ganglioside. The buildup of this fatty substance damages nerve cells in the brain and spinal cord. The amount of enzyme still being produced by the body affects the severity of the disease and the age of onset. By deploying the correction to the HEXA gene, scientists were able to increase the activity of the enzyme, known as beta-hexosaminidase A, delay symptom onset and significantly extend lifespan in the mouse model.
    • “With LOTS, a slight correction will go a long way. This editing may only need to increase enzyme activity by about 10% to keep symptoms from getting worse, and improve their quality of life,” said paper author Dr. Richard Proia of NIH’s National Institute of Diabetes and Digestive and Kidney Diseases. “We’ve figured out that opening the door to increased enzyme activity is possible, now we have to figure out how to do it in a person.”

From the U.S. healthcare business front,

  • Reuters reports,
    • “Shares of UnitedHealth Group (UNH.N), opens new tab surged nearly 14% on Friday after billionaire Warren Buffett’s Berkshire Hathaway (BRKa.N), opens new tab bought 5 million shares of the company, providing a shot in the arm for investors who think the health conglomerate will turn around under its new CEO.
    • “The shares have lost nearly half their value in the last year as the company struggled to adapt to rising healthcare costs and changes to government reimbursement plans that affected its health insurance and Optum patient care businesses.”
  • The Wall Street Journal relates,
    • “Nike co-founder Phil Knight and his wife, Penny Knight, are donating $2 billion to Oregon Health & Science University’s Knight Cancer Institute—the largest known single gift to a U.S. university, coming at a time when colleges’ public funding is under siege.
    • “The gift will roughly double the size of the cancer center, expanding its capacity to treat patients and conduct research. 
    • “The effort will be led by Dr. Brian Druker, a cancer-research pioneer known for developing Gleevec, a drug that transformed the survival of patients with chronic myeloid leukemia, a cancer of the blood and bone marrow. Druker, an OHSU professor who led the Knight Cancer Institute as chief executive officer until December, will return as the organization’s president. 
    • “We couldn’t be more excited about the transformational potential of this work for humanity,” the Knights said in a news release Thursday.”
  • Per Beckers Hospital Review,
    • “Hospitals and health systems are preparing for a rise in high-risk pregnancies, even as many labor and delivery units shut down. 
    • “Vizient company Sg2 projected that the proportion of high-risk pregnancies will accelerate alongside a rise in obesity-related comorbidities, including high blood pressure and diabetes. 
    • “Baptist Medical Center Jacksonville, part of Jacksonville, Fla.-based Baptist Health, is expanding its labor and delivery services in preparation for a 14.5% increase in high-risk pregnancies over the next decade, NPR affiliate WUSF reported Aug. 14. 
    • “The conundrum is this: Multiple health systems and hospitals are ending labor and delivery services, citing a decrease in birth rates, financial challenges and a workforce shortage. And although the national birth rate is declining, neonatal ICU admissions are increasing.
    • “There are a few factors contributing to the trend, including better survival rates of premature infants, an advancing maternal age and a rise in chronic maternal conditions. 
    • “In response to this trend, a different system of the same name, Little Rock, Ark.-based Baptist Health, announced in June an effort to improve maternal and children health outcomes for high-risk pregnancies. The initiative is Nashville, Tenn.-based Vanderbilt University’s Maternal Infant Health Outreach Worker Program, which targets economically disadvantaged and geographically isolated communities.” 
  • Per MedTech Dive,
    • “Oracle Health is releasing a new artificial intelligence-backed electronic health record, months after the technology giant first teased the “next generation” system.
    • “The EHR allows clinicians to use voice commands to access information, like a patient’s latest lab results or a list of current medications, cutting down the amount of time providers spend navigating through health records, the technology giant said in a press release Wednesday. 
    • “The AI-backed product is now available for ambulatory providers in the U.S., pending certification by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT, Bharat Sutariya, SVP and chief health officer at Oracle Health, told Healthcare Dive. Oracle plans to launch functionality for the acute care market in 2026.” 

Thursday report

David Ermer–CDC, CMS, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC

  • The OPM Director Scott Kupor announced an Award for Savings program which is open to OPM employees.
    • “For all savings identified between now and October 31, we will share 5% of the annual savings with whomever discovers it, up to $10,000 per award. To qualify, savings must be new actions not already identified, and we must be able to implement them.” 
  • Federal News Network reports,
    • “The Office of Personnel Management says new questions for federal job candidates, asking how they will advance the Trump administration’s policies, will appear on nearly all job applications, but candidates can still choose not to answer them without being penalized.
    • “OPM is telling agencies it is “mandatory” to include the Trump administration’s four new essay questions on nearly all applications on USAJobs, as part of the federal hiring process.” * * *
    • “In follow-up guidance, however, OPM downplayed the importance of the essays as just one piece of a candidate’s overall application. The HR agency said it’s optional for job candidates to answer the essays, and that candidates won’t be disqualified from consideration if they skip them.”
  • Federal News Network interviews Tammy Flanagan about smart tips to use when filling out the online federal retirement application.
  • NextGov/FCW tells us,
    • “The Trump administration is pushing forward in its deregulatory effort to overhaul the primary rules for how the government purchases goods and services, known as the Federal Acquisition Regulation.
    • “The FAR Council released new text for six parts of the FAR on Thursday — parts 4, 8, 12, 38, 40 and 51 — including the section dealing with commercial acquisition. 
    • “We’re removing hundreds of unnecessary requirements,” a senior administration official told Nextgov/FCW about the changes, offering the removal of requirements for commercial contractors to report the names and compensation of the five most highly paid executives as an example. 
    • “The goal is to reduce costs and time to deliver and increase competition, they said.”
  • The Wiley law firm has been doing a good job staying abreast of the FAR changes on its Decoding the FAR Overhaul website.
  • The American Hospital Association News points out,
    • “The White House Aug. 13 released an executive order directing the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response to develop a list of 26 drugs considered critical for national health and security. The order calls for the ASPR to gather a six-month supply of drug ingredients and place them in the Strategic Active Pharmaceutical Ingredients Reserve with a preference for domestic sourcing and manufacturing. The ASPR is also instructed to update a 2022 list of 86 essential medicines and propose a plan to obtain and store a six-month supply of drug ingredients for those remedies.”
  • and
    • “The Trump administration Aug. 13 issued an executive order revoking a 2021 order by the previous administration that established a “whole-of-government” effort to promote competition in the U.S. economy. The 2021 order encompassed 72 initiatives by more than a dozen federal agencies to address competition issues across the economy, including in health care, financial services, technology and agriculture. It also established a White House Competition Council tasked with coordinating, promoting and advancing federal efforts to improve competition in the U.S. economy.”
  • and
    • “The Department of Health and Human Services Aug. 14 announced it will reinstate the Task Force on Safer Childhood Vaccines, a federal panel to provide oversight on vaccines for U.S. children. The original task force was disbanded in 1998. HHS said the new group will work with the Advisory Commission on Childhood Vaccines to provide recommendations on developing, promoting and refining childhood vaccines that result in fewer and less serious adverse reactions than vaccines currently available, as well as improvements in vaccine development, production, distribution and adverse reaction reporting. 
    • “The new group will be led by senior leadership from the National Institutes of Health, the Food and Drug Administration and the Centers for Disease Control and Prevention. NIH Director Jay Bhattacharya will serve as chairman.” 
  • AHIP notes,
    • “A new peer-reviewed study published by The American Journal of Managed Care (AJMC) found that Medicare Advantage (MA) plans consistently delivered higher quality care than fee-for-service (FFS) Medicare before and during the COVID-19 pandemic.” * * *
    • “Nearly 35 million seniors and individuals with disabilities nationwide choose MA for their health coverage because it provides them with better care at lower costs than FFS. The new study’s findings add to a growing body of evidence that MA’s coordinated, value-based approach delivers superior quality and better health outcomes—while saving beneficiaries an average of more than $3,400 per year versus FFS.”
    • “Read the full study at AJMC, and learn more about the superior value of MA.”
  • Per Modern Healthcare,
    • “Penn Medicine and Saint Francis Health System recently received federal go-ahead to launch hospital-at-home programs, despite the program’s uncertain future.
    • “The Centers for Medicare and Medicaid Services’ Acute Hospital Care at Home waiver is set expire at the end of next month. Congress still must decide if it will extend or end the program, which provides Medicare reimbursement at the same rate for in-home care as in-facility care.
    • “Still, CMS approved waivers about two weeks ago for Tulsa, Oklahoma-based Saint Francis Health System’s program at two facilities.” 
  • and
    • “With just four months to go until a new, mandatory Medicare payment model commences, the hospital sector may be behind schedule.
    • “Health systems must ready themselves for the Transforming Episode Accountability Model, a five-year bundled payment demonstration known as TEAM, which sets episode-based fee-for-service Medicare reimbursements for five common procedures at nearly 750 hospitals.
    • “With just four months to go until a new, mandatory Medicare payment model commences, the hospital sector may be behind schedule.
    • “Health systems must ready themselves for the Transforming Episode Accountability Model, a five-year bundled payment demonstration known as TEAM, which sets episode-based fee-for-service Medicare reimbursements for five common procedures at nearly 750 hospitals.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “The Centers for Disease Control and Prevention (CDC) has not updated national measles statistics since August 6.  A notice on the CDC website that appeared after last week’s shooting said, “The data on this page will not be updated on Wednesday, August 13, 2025. CDC will resume updates as soon as possible.” * * *
    • “Colorado has reported a measles case in an unvaccinated child from Adams County who had recently traveled to Chihuahua state, which is Mexico’s measles hot spot. The child is under 5 years old and is hospitalized. * * *
    • “Idaho has confirmed its first measles case since 2023, in an unvaccinated child from Kootenai County. This county includes Coeur d’Alene, where measles was recently detected in wastewater. This marks the first confirmed case of measles in the Idaho panhandle since 1991.”
  • MedPage Today lets us know,
    • “In a nationally representative survey, 34% of U.S. adults were unaware of HPV and 38% were not aware of the HPV vaccine.
    • “Even individuals who were aware of HPV often didn’t know about its links to cervical and oral cancers.
    • “Public awareness of HPV and the HPV vaccine was lowest in Midwestern and Southern states.” * * *
    • “Given that the HPV vaccine has been approved in the U.S. for nearly two decades, “it was indeed surprising that a third of U.S. adults have not heard of HPV or the HPV vaccine,” Sonawane told MedPage Today. “Our hypothesis was in the range of 10% to 15%.”
  • Per the American Journal of Managed Care,
    • “Coinfection of HIV and HCV [Hepatitis C] leads to worse outcomes, necessitating effective HCV treatment in this population.
    • “Direct-acting antivirals show over 95% efficacy, yet HCV clearance rates in coinfected individuals remain below national targets.
    • “Study across seven U.S. jurisdictions showed modest increases in HCV clearance and testing rates among coinfected patients.
    • “Undetectable HIV viral loads and certain demographics, such as men who have sex with men, were linked to higher HCV clearance rates.
    • “Study limitations included incomplete data and potential COVID-19 pandemic impacts on results.”
  • Per Medscape,
    • “Hearing aid use was linked to fewer neuropsychiatric symptoms (NPS) in patients with dementia, such as apathy and irritability, than nonuse, new research showed.
    • “In a cross-sectional cohort study of more than 10,000 participants, hearing loss was not associated with a significantly greater number of symptoms than no hearing loss. However, the use of hearing aids in individuals with both dementia and hearing loss was linked to significantly fewer and less severe NPS than nonuse.
    • “Hearing aid use may represent an underutilized, nonpharmacological intervention to address NPS,” lead study author Ahjeetha Shankar, Johns Hopkins University School of Medicine, Baltimore, and colleagues wrote.”
  • Per Cardiovascular Business,
    • “Palliative care should play a significant role in the day-to-day management of heart failure (HF) patients, according to new recommendations from the Heart Failure Society of America (HFSA).
    • “HF patients are associated with high mortality and a considerably worse quality of life, the group wrote. Care teams should be doing everything in their power to help patients control their symptoms and live the best lives possible. 
    • “The HFSA guidance is available in full in the Journal of Cardiac Failure. * * *
    • “Click here to review the full consensus statement.”
  • STAT News reports,
    • “A study in rural China demonstrating the power of intensive blood pressure control clinched the deal. The large, cluster-randomized controlled trial convincingly demonstrated that well-controlled blood pressure — below 130/80 mm Hg — lowered the risk of dementia by 15% and cognitive impairment by 16%. 
    • “That was the solid evidence reviewers needed to form the foundation for a new guideline from leading medical groups on how to treat high blood pressure, Dan Jones, chair of the guideline writing committee and a past president of the American Heart Association, told STAT. He called the study from China the first one to definitively show that rigorous lowering of blood pressure with a goal of below 120 systolic does decrease the risk of dementia.”
    • “We don’t have recommended changes related to dementia but we are able to say with certainty that lowering blood pressure reduces the risk of dementia and that’s such good news for people around the world and for Americans,” said Jones, a former dean of the University of Mississippi School of Medicine.”
  • and
    • “In a small study, an engineered antibody showed “amazing” promise in countering metastatic cancer.
    • “That is, according to a Phase 1 clinical trial published Thursday in Cancer Cell. Researchers directly injected the drug, which stimulates the immune system to attack cancer cells, into 12 patients’ tumors. Six of the patients had significant tumor reduction even in non-injected sites, with two experiencing complete remission. The research could lay the groundwork for new treatments for the most advanced cancer patients.
    • “Seeing this in humans is really great news,” said Katelyn Byrne, a cancer biologist at Oregon Health and State University who was not involved in the study. “Especially for patients where we don’t have any options on the table, to be able to put this on the table now — it’s amazing.” 
  • The New York Times adds,
    • “Treating chronic pain is hard. An experimental approach shows promise.
    • “A guitarist in a death metal band was one of several people who found that personalized deep brain stimulation eased their pain and helped them reduce pain medication.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans tells us,
    • “U.S. employers project a median health care cost increase of 10% for 2026, according to new survey results from the International Foundation of Employee Benefit Plans. A similar Foundation survey conducted in 2024 projected a median cost increase of 8% for 2025.” * * *\
    • “When I spoke to Julie Stich, CEBS, Vice President of Content at the International Foundation, she shared that the 10% projected increase is attributed to a variety of factors impacting organizations’ medical plan costs, with catastrophic claims and specialty/costly prescription drugs topping the list. Employers have indicated that cost-sharing, plan design and purchasing/provider initiatives will be the most impactful techniques to manage costs.”
  • The Wall Street Journal reports,
    • “Pharma giant Eli Lilly said it is negotiating to raise drug prices in Europe, starting in the U.K. with the weight-loss drug Mounjaro, so that it can comply with the Trump administration’s goal of bringing down prices in the U.S.
    • “Lilly said Thursday that it has an agreement with the U.K. government to raise the list price of Mounjaro for patients who pay for it out-of-pocket. Lilly will more than double the list price of Mounjaro’s highest dose from about $165 to about $446. The new price is in line with the prices paid in the rest of Europe and other developed countries, Lilly said. 
    • “Mounjaro is the only Lilly medicine with a significantly lower list price in the U.K. than average prices in Europe and other developed countries, so we are adjusting the list price to bring it into line with these countries,” a Lilly spokesman said. 
    • “The higher price, however, won’t apply to those who get it prescribed through the U.K.’s National Health Service, the spokesman said.
    • “The move is part of the pharmaceutical company’s talks with foreign governments to raise prices in developed nations, the company said. It plans to implement any price adjustments by Sept. 1.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group and Amedisys have officially closed their $3.3 billion merger deal just one week after securing a key settlement agreement with the feds that allowed proceedings to advance.
    • “In a filing with the Securities and Exchange Commission, Amedisys said that the deal had officially closed Thursday, just over two years from when it was announced in late June 2023.
    • “That makes the home health company now a wholly-owned subsidiary of UnitedHealth, where it will join the company’s Optum unit. Amedisys was originally set to be acquired by Option Care Heath, but the organization was outbid by UnitedHealth.
    • “To make sure the merger was consummated, the two parties agreed last week to divest 164 home health and hospice facilities across 19 states, securing approval from the Department of Justice to move forward.”
  • and
    • “Humana and health tech company DrFirst are joining forces in a bid to close gaps in care for people with chronic health needs.
    • “The program’s initial launch focuses on boosting the use of statins among eligible members, which can improve care for people with cardiovascular conditions or diabetes while also meeting a key Medicare metric set by the Centers for Medicare & Medicaid Services.
    • “DrFirst’s prescription orchestration platform is embedded in the provider’s workflow, and through it, Humana can send the clinical team prescription recommendations for high-risk patients. Should they agree with the suggestion, the provider can then with one click submit a script and document why the care was necessary.
    • “I think it’s a very simple and very elegant way of helping the insurer and the provider get on the same page without requiring external workflows, external portals, external faxes,” Colin Banas, M.D., chief medical officer for DrFirst, said in an interview with Fierce Healthcare.
  • Per MedTech Dive,
    • “Apple said Thursday that it is updating its watches with a redesigned blood oxygen feature after a recent U.S. customs ruling. The software update will go out to the Apple Watch Series 9, Series 10 and Ultra 2 devices on Thursday.” * * *
    • “With the update, sensor data from Apple’s blood oxygen app will be measured, calculated and displayed in the paired iPhone app. Previously, the readings were displayed on the user’s watch. Apple said that there will be no change to previously purchased Apple Watches that have the original blood oxygen feature or devices sold outside of the U.S.”

Midweek Update

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Today, the Government Accountability Office released a report on priority open recommendations made to the U.S. Office of Personnel Management.
    • “In May 2024, GAO identified 16 priority recommendations for the Office of Personnel Management (OPM). Since then, OPM has implemented three of those recommendations.
      • Specifically, OPM took actions to better mitigate cybersecurity risks, improve its payroll database, and strengthen privacy protections for personally identifiable information on its IT systems.
    • In August 2025, GAO identified one additional priority recommendation for OPM, bringing the total number to 14. These recommendations involve the following areas:
      • preventing improper payments,
      • strengthening IT security and management,
      • addressing mission critical skills gaps,
      • improving the federal classification system,
      • making hiring authorities more effective,
      • improving payroll data, and
      • addressing employee misconduct and improving performance management.
    • OPM’s continued attention to these issues could lead to significant improvements in government operations.
  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) this week released new data fueling a narrative of rampant broker fraud on the Affordable Care Act (ACA) exchanges.
    • “Plans received data finding 23% of enrollees did not have a claim in 2019. That number jumped sharply to 35% last year.
    • “Before the pandemic, the data were largely consistent across three categories: members on state-based exchanges, members on the federal exchange in Medicaid expansion states and on the federal exchange in non-expansion states. No matter the group, about 22% to 24% of enrollees did not have a claim.
    • “But, by 2024, expansion states on the federal exchange saw an increase from 22% to 32%, and the non-expansion population jumped from 24% to 41% without a claim, according to the agency’s data. Meanwhile, enrollees on state-based exchanges without claims climbed modestly from 22% to 24%.”
  • The suspicion is that brokers have been adding phantom enrollees to highly federal government subsidized silver and bronze plans.
    • The Paragon Health Institute adds,
      • “As Paragon discussed in our The Great Obamacare Enrollment Fraud series, large-scale fraud schemes have led to people enrolling in exchange plans without their knowledge, and others being misled by false offers of cash or gift cards to apply for insurance. A few months ago, a Bloomberg exposé revealed fraud rings in Florida, including brokers earning thousands daily by enrolling people who often had no idea.”
  • An HHS news release features a trip that HHS Secretary Robert F. Kennedy took to Alaska last week to highlight rural and tribal health priorities.
  • Beckers Health IT considers whether the Trump administration can achieve its goal of doing away with clipboards in healthcare. It’s worth pointing out
    • “Curtis Cole, MD, vice president and chief global information officer of Ithaca, N.Y.-based Cornell University, said he’s “hopeful that something positive” will come from the plan, but he’s not “particularly sanguine.”
    • “A lot of it looks like the all-too-frequent use of computers to make bad processes work faster, rather than fixing the fundamental problem,” he said.
    • “He pointed to the lack of a national patient identifier, which other developed nations have. The Trump administration is advocating for digital identity verification to link patients to their records, but Dr. Cole says those systems often have incorrect or incomplete information.”
  • HIPAA, a 1996 federal law, calls for HHS to create a national patient identifier but Congress has blocked funding for that initiative. 
  • STAT News reports,
    • “A handful of drug companies have formed a group to present lawmakers with research on what the industry sees as the negative impacts of Medicare drug price negotiations, according to lobbying records.
    • “The group is called the IRA Watchdog after the Inflation Reduction Act, which directed Medicare to negotiate the prices for some drugs. Its members are Merck, AstraZeneca, Bristol Myers Squibb Company, and Eli Lilly, according to lobbying disclosure records. The group describes itself as a “coalition analyzing the impact of Medicare Drug Price Negotiation on patients.” * * *
    • “The IRA Watchdog is not a stand-alone lobbying organization. It’s housed in the firm DLA Piper, and its two lobbyists were staffers for former Sen. Richard Burr (R-N.C.), who while in Congress championed the biotech sector, a key driver of the economy in his home state. Burr is a senior policy adviser at DLA Piper and the chair of its health policy strategic consulting practice.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Insmed has gained approval for its second lung disease medicine, announcing Tuesday Food and Drug Administration clearance of Brinsupri to treat a chronic condition that results in dilated airways in the lungs, chronic cough and frequent respiratory infections.
    • “Brinsupri is the first drug to treat bronchiectasis not caused by cystic fibrosis and the first in a new class of drugs called DPP-1 inhibitors that could treat multiple inflammatory conditions. Startup Expedition Therapeutics just signed a deal with Fosun Pharma for most rights to a DPP-1 inhibitor, while Boehringer Ingelheim and Haisco Pharmaceutical Group have drugs in development.
    • “Wall Street analysts forecast as much as $6 billion in annual sales for Brinsupri. Insmed’s market valuation has swelled to more than $25 billion in anticipation of coming sales from Brinsupri, its other approved drug Arikayce and pipeline candidates in lung disease and Duchenne muscular dystrophy.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “Fewer Americans are reporting that they drink alcohol amid a growing belief that even moderate alcohol consumption is a health risk, according to a Gallup pollopens in a new tab or window released Wednesday.
    • “A record high percentage of U.S. adults, 53%, now say moderate drinking is bad for their health, up from 28% in 2015. The uptick in doubt about alcohol’s benefits is largely driven by young adults — the age group most likely to believe drinking “one or two drinks a day” can cause health hazards — but older adults are also now increasingly likely to think moderate drinking carries risks.
    • “As concerns about health impacts rise, fewer Americans are reporting that they drink. The survey found that 54% of U.S. adults said they drink alcoholic beverages such as liquor, wine, or beer. That’s lower than at any other point in the past three decades.
    • “The findings of the poll, which was conducted in July, indicate that after years of many believing that moderate drinking was harmless — or even beneficial — worries about alcohol consumption are taking hold. According to Gallup’s data, even those who consume alcohol are drinking less.”
  • Health Day informs us,
    • “Nearly 70 percent of U.S. children in car crashes with a fatality are not using proper child passenger restraints, according to a study published online July 31 in Traffic Injury Prevention.
    • “Arthi S. Kozhumam, from the Northwestern University Feinberg School of Medicine in Chicago, and colleagues identified child, driver, vehicle, neighborhood, and policy-level factors associated with suboptimal child passenger safety practices in motor vehicle collisions (MVCs) with a fatality. The analysis included data from child passengers (younger than 13 years old) in cars and light trucks with known restraint status and seating location identified from the Fatality Analysis Reporting System database (2011 to 2021).”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-supported clinical trial has found that the outcome of treating complicated Staphylococcus aureus bloodstream infections with two intravenous (IV) doses of the antibiotic dalbavancin seven days apart is just as good as daily IV doses of conventional antibiotics over four to six weeks. Nearly 120,000 S. aureus bloodstream infections and 20,000 associated deaths occurred in the United States in 2017. The study results provide the clearest evidence to date for the safety and effectiveness of dalbavancin therapy for complicated S. aureus bloodstream infections, expanding the number of antimicrobial treatment options for clinicians and patients. The findings were published today in the Journal of the American Medical Association.
    • “Given the small number of antimicrobial drugs available to treat Staphylococcus aureus bloodstream infections and the bacteria’s growing drug resistance, establishing dalbavancin as a beneficial therapy for these severe infections gives us a vital new alternative to treat them,” said John Beigel, M.D., the acting director of the Division of Microbiology and Infectious Diseases at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which sponsored and funded the trial.”
  • Medscape offers “Perspectives on Managing Antibiotic Resistance.”
  • Per MedPage Today,
    • “Men had higher mortality and hospitalization rates than women after a dementia diagnosis.
    • “These relationships held even after controlling for age and comorbidity burden.
    • “The study was based on over 5.7 million Medicare patients with up to 8 years of follow-up.”
  • and
    • “Applying five published definitions for long COVID yielded a prevalence that ranged from 30.84% to 42.01% at 3 months and 14.23% to 21.94% at 6 months.
    • “Up to a third of the variation in prevalence rates could be attributed to the differences in long COVID definitions.
    • “While ideal, there may never be a single, standardized long COVID definition, given the divergent needs of researchers and clinicians.”
  • and
    • “Clear” e-cigarettes had disproportionately greater cardiovascular effects than other types of vapes when smoking conditions were controlled.
    • “Clear” e-cigarettes contained synthetic coolants, menthol, and other flavorings despite their marketing.
    • “Acute increases in blood pressure may be related to the synthetic coolants reducing tobacco or nicotine harshness and facilitating deeper inhalation.”
  • The National Institute of Standards and Technology explains why “Wearable, Implantable and Ingestible Medical Devices Could Revolutionize Your Health Care.”
  • Genetic Engineering and Biotechnology reports,
    • “Targeted DNA editing by CRISPR technology has great potential for applications in biotechnology and gene therapy. However, precise gene editing remains a challenge largely due to insufficient control of the DNA repair process. While mechanisms exist to accurately repair double-stranded breaks, DNA end joining repair can occasionally lead to genetic errors.  
    • “In a new study published in Nature Biotechnology titled, “Precise, predictable genome integrations by deep learning–assisted design of microhomology-based templates,” researchers at the University of Zurich (UZH) have found that repair at the genome-cargo interface is predictable by artificial intelligence (AI) models and adheres to sequence-context-specific rules. The AI tool, named “Pythia,” predicts how cells repair their DNA after it is cut by CRISPR/Cas9 and opens the door to more accurate modeling of human diseases and next-generation gene therapies. 
    • “Just as meteorologists use AI to predict the weather, we are using it to forecast how cells will respond to genetic interventions. That kind of predictive power is essential if we want gene editing to be safe, reliable, and clinically useful,” said Soeren Lienkamp, PhD, professor at the Institute of Anatomy of UZH and co-corresponding author of the study.” 

From the U.S. healthcare business front,

  • Fierce Healthcare relates,
    • “Providence posted a $21 million operating loss (-0.3% operating margin) for the second quarter of the year as elevated volumes and revenues outpaced year-over-year expense increases.
    • “The operating performance is an improvement over the prior year’s $123 million operating loss (-1.6% operating margin), for which the 51-hospital nonprofit credited its “continued focus on staffing and reductions from expense management initiatives.” The system is sitting at a $265 million operating loss (-1.7% operating margin) across six months.
    • “Providence executives cheered the system’s steady march toward breakeven after several consecutive years of losses.
    • “Still, the organization stressed a slew of economic headwinds it refers to as a “polycrisis” affecting nonprofit health systems like Providence as cause for continued expense reduction. Among these are inflation, tariffs, new state regulations around staffing and charity care, payment delays from commercial payers and the impending federal funding cuts of the “one big, beautiful bill.” 
  • and
    • “Health tech and artificial intelligence companies see ripe opportunities to offer solutions that help patients access and share their medical data with digital health apps. And it comes at a time when the federal government is pushing for consumer-directed data exchange.
    • “HealthEx, a company that built data rights management solutions, launched a platform to provide real-time patient access to complete health records. The company worked with a team of industry partners to develop a process that verifies patient identity, captures consent and retrieves clinical records, enabling the data to flow without the patient doing multiple patient portal logins.
    • “The company aims to create an “Apple Wallet” for health records, executives said.
    • “CLEAR, an identity verification tech company often found at airports, worked with HealthEx on the initiative, along with national electronic health record company athenahealth, healthcare interoperability company MedAllies and the CommonWell Health Alliance.”
  • Beckers Hospital Review points out,
    • “Three-quarters of the hospitals on U.S. News & World Report’s 2025-26 Honor Roll list also earned top marks in CMS’ latest Overall Hospital Quality Star Ratings, underscoring a notable overlap in national measures of hospital excellence. 
    • “CMS released its 2025 star ratings Aug. 6, evaluating more than 4,600 hospitals nationwide on 46 quality measures spanning mortality, safety, patient experience, readmissions, and timely and effective care. This year, 290 hospitals earned a five-star rating. U.S. News published its 2025-26 Honor Roll on July 29, recognizing 20 hospitals for top performance across 15 specialties and 22 procedures and conditions.
    • “While the two lists use different methodologies and scoring systems, their alignment highlights organizations that excel across quality- and reputation-based benchmarks.”
  • Beckers Payer Issues notes,
    • “Optum has acquired Kingsport, Tenn.-based Holston Medical Group, WJHL reported Aug. 11. 
    • “The 200-provider medical group has more than 70 locations in Northeast Tennessee and Southwest Virginia, according to the report. 
    • “Holston Medical Group is pleased to join Optum to support our efforts to continue to provide exceptional health care services to patients in the communities we serve,” an Optum spokesperson said in a statement shared with the news outlet. “Holston Medical Group and Optum share common goals around providing patients with high-quality, local care with a focus on value and innovation. We look forward to the breadth of clinical expertise and capabilities that we will gain as part of Optum.”
  • Per BioPharma Dive,
    • “PureTech Health, a biotechnology firm with a web of startup subsidiaries, announced Tuesday the launch of a new company that will develop a respiratory disease treatment it’s been advancing through clinical testing.
    • “Called Celea Therapeutics, the company debuts with a drug candidate nearing late-stage trials that the company believes could treat multiple inflammatory lung diseases. Known as deupirfenidone or LYT-100, the drug is initially being evaluated against idiopathic pulmonary fibrosis, a rare and chronic condition. 
    • “Sven Dethlefs, who has spearheaded the deupirfenidone program under PureTech over the last year, will lead Celea. Prior to joining PureTech, Dethlefs was the CEO of Teva North America, where he oversaw the company’s specialty and generic businesses in the U.S. and Canada.”
  • Per MedTech Dive,
    • “Heartflow’s initial public offering grossed $364.2 million after the volume and price of the shares sold exceeded the original expectations.
    • “The company listed last week and completed the sale of the overallotment on Monday, adding almost $50 million through the sale of additional shares.
    • “Heartflow’s stock rose in its first two days on public markets, closing at almost $30 on Monday. The company priced its IPO at $19 a share.
    • “Heartflow has developed software for making 3D heart models from coronary computed tomography angiography scans. In a clinical trial, the company linked its lead product, Heartflow FFRCT Analysis, to a 78% improvement in identifying patients in need of revascularization.”

Tuesday report

David Ermer–CDC, FDA, Medical / Rx research, Obesity, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Bloomberg informs us,
    • “Scott Kupor, the new director of the US government’s human resources agency [OPM], wants to make it easier to fire federal workers and drop college degree requirements for certain jobs.
    • “Kupor is exploring ideas to lure young talent from Silicon Valley and other industries, including relieving student debt and creating “information exchanges” between the private and public sectors.
    • “Kupor also suggests potentially investing pension money in a sovereign wealth fund, saying “every other major country has a sovereign wealth fund where they have professional money managers who actually manage their retirement assets on behalf of the population.” * * *
    • “[Kupor] acknowledged that he can’t move on many of these ideas without the support of the White House, Congress or other agencies, like the Treasury Department. Kupor hasn’t raised many of these proposals with the White House yet, but said his team is engaged with the executive branch on a daily basis.”
  • MedTech Dive tells us,
    • “The U.S. is extending its pause on additional retaliatory tariffs for imports from China until Nov. 10, according to an executive order signed by President Donald Trump on Monday.
    • The order said the extension is appropriate following “significant steps” from China on addressing U.S. trade concerns in ongoing discussions between the two countries.
    • Since May 14, the U.S. has been charging many imports from China an extra 30% duty. That rate — a combination of 20% tariffs tied to fentanyl trafficking and a 10% baseline reciprocal tariff — came as the two countries agreed to pause duties imposed as part of a tit-for-tat tariff escalation for 90 days. The pause was originally set to expire Aug. 12.

From the Food and Drug Administration front,

  • Per HCPLive,
    • “FDA approval of PharmaTher’s ketamine for surgical pain management follows minor application deficiencies, without requiring new trials.
    • “Ketamine’s inclusion on the WHO’s Essential Medicines list and its shortage since 2018 have led to the use of compounded products with potential risks.
    • “The ketamine market is expected to grow from $750 million to $3.42 billion by 2035, with a 16.4% compound annual growth rate.
    • “This approval supports further ketamine development for psychiatric, neurological, and chronic pain disorders, aligning with PharmaTher’s strategic goals.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has identified a Class I recall of Draeger SafeStar and TwinStar Filters due to a risk of misleading carbon dioxide readings. The readings could result in health care providers administering unnecessary or harmful treatments based on incorrect waveform interpretations. Using the affected filters could result in serious injury or death.
    • “In addition, the FDA Aug. 9 released a notice on a voluntary DermaRite recall of its DermaKleen, Dermasarra, Kleenfoam and Perigiene products due to a microbial contamination that can result in serious and life-threatening infections.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Bayer BAYN said it would commercialize and complete research into a new potential cancer drug developed by U.S. biotech company Kumquat Biosciences.
    • “Under the global exclusive license deal, announced by both companies on Tuesday, Kumquat will be responsible for the Phase 1a study of its KRAS G12D inhibitor, while Bayer will work on taking the drug to market.
    • “The inhibitor targets a type of change in the DNA of genes that drives the growth of tumors, and is most frequently linked to pancreatic, colorectal and nonsmall cell lung cancers.
    • “As part of the agreement, Kumquat will receive up to $1.3 billion, and additional tiered royalties on net sales, they said.”
  • BioPharma Dive lets us know,
    • “Padcev, an antibody-drug conjugate Pfizer acquired in its $43 billion buyout of Seagen, met the primary goal of a bladder cancer trial, helping people ineligible for chemotherapy when used in combination with Merck & Co.’s Keytruda before and after surgery, the companies said Tuesday.
    • “The drugmaker said it will discuss approval applications with health regulators, which could expand Padcev’s use in bladder cancer into the so-called neo-adjuvant and adjuvant settings. Padcev is currently used with Keytruda in locally advanced and metastatic disease that can’t be operated on, and alone in people whose disease has progressed after treatment.
    • “Padcev, which is co-promoted with Astellas in the U.S., is a fast-growing drug in Pfizer’s oncology business — on track to record around $2 billion in sales in 2025. Pfizer has been under pressure because of declining revenue from its COVID-19 vaccine and drug, and is looking to new products to lift sales.”
  • Medscape discusses the repurposing cancer drugs to treat Alzheimer’s Disease.
  • Per MedPage Today,
    • “The risk of new-onset diabetic retinopathy (DR) increased slightly, but significantly, in patients taking GLP-1 receptor agonists for diabetes, despite a lower risk of vision-threatening complications, a large retrospective study suggested.
    • “A propensity-matched comparison showed a 7% higher incidence of new DR among users of GLP-1 agonists. The risk of ischemic optic neuropathy did not differ significantly between users and non-users. Moreover, in a subgroup of patients with existing DR, use of the drugs was not associated with an increased risk of progression to proliferative retinopathy or diabetic macular edema (DME).
    • “The findings suggest that patients with type 2 diabetes treated with GLP-1 agonists require regular screening and monitoring for ophthalmic complications, regardless of baseline DR status, reported Sarju Ganatra, MD, of Beth Israel Lahey Health in Burlington, Massachusetts, and co-authors in JAMA Network Open.”

From the U.S. healthcare business front,

  • Beckers Hospital Reviews tells us,
    • “Physicians and advanced practice providers are logging more work than ever, but rising productivity isn’t translating into higher reimbursement, according to Kaufman Hall’s “Physician Flash Report,” published Aug. 11. 
    • “Productivity levels, measured in work relative value units per full-time employee, reached 6,449 for physicians and 5,030 for advanced practice providers in the second quarter of 2025. That marks a 12% increase for physicians and an 11% increase for APPs year over year.
    • “Increases in productivity metrics, coupled with higher compensation and expenses, reflect a reality that physicians and advanced practice providers are working more than ever before,” Matthew Bates, managing director and physician enterprise service line leader at Kaufman Hall, said in a news release. “Revenue has increased because physicians and providers are working more, but the data also show that reimbursement is not keeping pace. In the coming months if more patients lose insurance coverage, this trend will likely get worse.”
    • “Kaufman Hall analysts said changes to the Medicare physician fee schedule that took effect in 2021 — which initially increased wRVU totals for evaluation and management services — no longer account for the recent growth in productivity. The increases now reflect rising workloads rather than changes in how work is measured.
    • “The report also highlighted a troubling staffing trend.  Medical support staff levels continue to fall relative to wRVU generation, a pattern Kaufman Hall has tracked since 2023. The firm cautioned that ongoing workforce challenges could become a barrier to future growth if left unaddressed.
    • “Meanwhile, hospital financial performance improved in June, according to Kaufman Hall’s latest “National Hospital Flash Report.” Outpatient revenue and operating room minutes increased, contributing to stronger performance compared to the previous month.
    • “Higher performing hospitals are nimbler on both the revenue and expense sides,” said Erik Swanson, managing director and data and analytics group leader at Kaufman Hall. “They may be expanding their outpatient footprint, diversifying services, or managing expenses like purchased services by centralizing some functions. They are also more likely to have value-based care or bundled care arrangements in place.”
  • Modern Healthcare reports,
    • “Healthcare systems are reassessing their urgent care strategies as patient demand shifts and tried-and-true business models no longer bring the same returns. 
    • “Many systems are looking to facility acquisitions and joint ventures to access new patients through the lower-cost settings, rather than just provide a one-off visit. However, the booming urgent care business has turned into oversaturation in some areas, leaving systems to decide whether their resources would be better used elsewhere.”
    • Provider groups of all sizes have tapped into the urgent care model, but recent growth is driven by larger institutions, such as private equity-backed platforms and health systems, Urgent Care Consultants President Alan Ayers said. More than 430 urgent care centers opened in new locations in the first half of 2025. Nearly 40% of those centers are affiliated with hospitals, according to data from Urgent Care Consultants. 
    • Systems are increasingly viewing urgent care centers as an entry point into the larger organization that can beef up patient volumes. Health systems have to reevaluate where they stand amid retail clinics, telehealth services and other competitors. Transactional patient interactions at many urgent care centers are not sustainable, system executives said.”
  • and
    • “Cardinal Health announced an agreement to purchase Solaris Health in a $1.9 billion deal, the company’s latest acquisition in the urology category and an expansion of its multispecialty strategy.
    • “Urology is an attractive specialty for us,” said Jason Hollar, chief executive officer of Cardinal Health, in a statement. Among other recent urology acquisitions, Cardinal Health recently completed the purchase of Academic Urology & Urogynecology.
    • “Solaris Health has more than 750 providers in 14 states.”
  • and
    • “Highmark Health and clinical documentation vendor Abridge are developing a tool that uses generative artificial intelligence to approve prior authorization requests at the point of care, the companies announced Tuesday.
    • “The Pittsburgh-based health system and Blue Cross Blue Shield insurer will incorporate the software into its operations, and Highmark Health and Abridge have bigger plans.
    • “The companies intend to eventually market the utility to other health insurance companies, said Highmark Health Chief Analytics Officer Richard Clarke.” 
  • Beckers Hospital Review points out,
    • “Oak Park, Ill.-based West Suburban Medical Center is facing an uncertain future after its sister hospital, Weiss Memorial Hospital in Chicago, closed Aug. 8 prior to CMS’ termination of its Medicare program Aug. 9, NBC 5 Chicago reported.
    • “El Segundo, Calif.-based Pipeline Health System sold West Suburban and Weiss Memorial to Princeton, N.J.-based Resilience Healthcare in late 2022.”
  • Per Fierce Healthcare,
    • “Maven Clinic, a global virtual clinic for women’s and family health, is launching new features to support women and men trying to conceive.
    • “Understanding the menstrual cycle is key to increasing chances of conceiving naturally. Yet Maven providers say that new members in its Trying to Conceive track—intended to support natural conception—often do not understand their ovulation. Even though nearly 75% of members report tracking their cycles in apps, many still struggle to interpret the data. 
    • “Nobody uses a physical calendar anymore. Everyone tracks their fertility on a device or an app,” Neel Shah, M.D., Maven’s chief medical officer, explained. But simply tracking dates may not be enough. “Getting pregnant is about attempts. People might think they’re trying within their fertile window, but they’re not ovulating, and so it’s not going to work.” 
    • “Maven’s new cycle tracker, available to Fertility & Family Building members starting this fall, learns each member’s unique cycle and offers personalized predictions. It can flag possible irregularities and recommend appointments with a Maven specialist to determine potential underlying diagnoses. Finding these out early could save couples money and stress, Shah said. For example, an irregular period might be caused by a thyroid condition that could be addressed with a $5 medication.
    • “The tracker is integrated with the Apple Watch and will soon also be integrated with the Oura Ring. Wearables can offer important insights relevant to a woman’s cycle, such as body temperature, heart rate or and sleep data, according to Shah.
    • “Complementary to the offering are at-home semen test kits for men.” 

Monday update

David Ermer–CDC, CMS, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM) today issued new government-wide guidance to ensure that performance awards are meaningfully targeted to the highest-performing federal employees. The updated policy directs agencies to strengthen performance management practices, normalize ratings, and reserve the largest awards and bonuses for employees who have demonstrated exceptional contributions to their agencyʼs mission. The guidance also encourages agencies to expand use of non-cash awards, such as time-off and quality step increases, and to recognize real-time accomplishments throughout the year
  • Per an HHS news release,
    • “Health and Human Services Secretary Robert F. Kennedy, Jr. visited the CDC headquarters in Atlanta today in response to Friday’s tragic gunfire attack that claimed the life of DeKalb County Police Officer David Rose. 
    • “CDC security led Secretary Kennedy on a tour of the Roybal Campus, pointing out shattered windows across multiple buildings, including the main guard booth. Health and Human Services Deputy Secretary Jim O’Neill and CDC Director Susan Monarez accompanied him on the tour. 
    • “Secretary Kennedy visited the DeKalb County Police Department, where he met with Police Chief Greg Padrick. Later, he met privately with the widow of Officer David Rose, who courageously gave his life in the line of duty. He offered his deepest condolences and reaffirmed the agency’s commitment to honoring Officer Rose’s bravery, sacrifice, and service to the nation.” 

From the judicial front,

  • It occurred to the FEHBlog this afternoon that we recently passed the August 7 deadline for the parties to submit a joint status report to the federal court considering a challenge to the Biden Administration’s 2024 mental health parity rule amendments.  
    • It turns out that the status report (Dropbox link) was timely submitted on August 7.
    • The parties reported,
      • “The Departments continue to consider whether to issue a notice of proposed rulemaking to revise or rescind the 2024 Rule and to determine when it would be appropriate to add a MHPAEA regulatory action to the agencies’ Semiannual Regulatory Agenda.
      • “Pursuant to the Court’s May 12, 2025, Minute Order, the parties will file another joint status report on or before November 5, 2025, to report on Defendants’ progress.” 
    • The most recent semi-annual regulatory report appearing on reginfo.gov is Fall 2024 dated 12/13/2024.
  • Fierce Healthcare reports,
    • “Hospital and health system groups are skeptical the Trump administration will have enough time to weigh and incorporate providers’ concerns before opening its 340B rebate pilot program up to drugmaker applicants. 
    • “In a letter sent to the Health Resources and Services Administration (HRSA), which oversees the controversial subsidy program, seven provider associations requested HRSA extend the timeline for stakeholder comments and give itself a broader window to consider public comments. 
    • “Specifically, the current timeline outlined by HRSA in late July requires comments on the program to be submitted by Sept. 8, and for drugmakers to submit their applications and rebate plans by Sept. 15. Approvals would be made by Oct. 15, and the pilot is slated to begin at the top of the year 
    • “Instead, the associations have floated a Sept. 15 comment period, an Oct. 20 manufacturer application deadline and a Nov. 3 approval date.
    • “With the fundamental changes a rebate model will impose on all 340B stakeholders, it is impossible for the agency to meaningfully consider, in just seven days, all the feedback it will surely receive,” the associations wrote in their letter (PDF). “Moreover, drug companies have spent years developing and preparing for a rebate model, but the agency’s current timeline would give 340B hospitals far less time to prepare.”

From the public health and medical research,

  • The American Medical Association lets us know what doctors wish their patients knew about joint injuries and treatment.
  • Consumer Reports, writing in the Washington Post, discusses “how to get more out of physical therapy. It can reduce pain, boost strength, get you as healthy as possible for surgery and more.”
  • Medscape lets us know what doctors wish their patients knew about “How High-Fiber Diets and Supplements Can Improve Health for Patients With Obesity.”
  • Per MedPage Today,
    • “Previous research on associations between prediabetes and mortality has produced conflicting results.
    • “This study found that prediabetes was statistically significantly associated with mortality only among adults ages 20 to 54 years.
    • “Mortality risk in younger adults could be due to metabolic or behavioral risk factors.” * * *
    • “Elizabeth Selvin, PhD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, who was not involved in the study, told MedPage Today that the findings were “very consistent with [the 2019 study] demonstrating that prediabetes in older adults is not strongly associated with mortality.”
    • “Current definitions of prediabetes are very broad and they capture a lot of people who are not at high risk for poor outcomes, especially in old age,” she said. “In older ages, mild elevations in glucose are extraordinarily common and seem to reflect mild metabolic dysfunction corresponding with aging rather than severe hyperglycemia that leads to diabetes.”
  • BioPharma Dive reports,
    • “An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits on Monday. 
    • “IO Biotech, however, still believes the vaccine performed well enough to warrant a potential approval consideration from U.S. regulators. The company noted how the study, which compared a regimen of its shot and Merck & Co.’s immunotherapy Keytruda to Keytruda alone, failed by the slimmest of margins. Executives also pointed to other analyses showing potentially stronger benefits among those who hadn’t previously received drugs like Keytruda or aren’t likely to respond to them. 
    • “It was a very narrow miss, just by a hair,” said Mai-Britt Zocca, IO’s CEO, on a Monday conference call with Wall Street analysts.
    • “Called Cylembio, IO’s cancer vaccine consists of engineered peptides that are supposed to provoke an immune response to certain proteins expressed on tumor cells. Those proteins are two of the immune “checkpoints,” PD-L1 and IDO1, long studied by drugmakers.”
  • and
    • “An experimental Novartis drug has succeeded against a tough-to-treat autoimmune condition, boosting the outlook for a multibillion-dollar acquisition the Swiss pharmaceutical company made last year. 
    • “According to Novartis, the drug, called ianalumab, met its main goal in two Phase 3 studies in Sjögren’s syndrome, a chronic and progressive immune disease. Novartis didn’t provide specifics, but said Monday that treatment with ianalumab led to statistically significant improvements in disease activity compared to a placebo in each trial, as measured by a widely used index evaluating symptoms. The drug was also “well tolerated” and demonstrated “a favorable safety profile,” the company said in a statement. 
    • “Novartis will share the findings at an upcoming medical meeting and submit them to global health regulators.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente closed its second quarter of the year with a billion dollars of operating income and a $3.3 billion bottom line—but operating headwinds on the horizon have leadership taking a hard look at the health system’s cost structure and potential efficiencies.
    • “The quarter’s performance is a step ahead of last year, when the integrated nonprofit reported $908 million of operating income and $2.1 billion in net income.
    • “It’s also a fair jump in the scale of Kaiser’s operations. Consolidated operating revenues and expenses during the most recent quarter were $32.1 billion and $31.1 billion, respectively, up from $29.1 billion and $28.2 billion in the second quarter of 2024. These reflect a 3.2% operating margin in the second quarter of 2025 and a 3.1% operating margin in the second quarter of 2024.
    • “Together with the year’s opening quarter, Kaiser now sits at about $63.9 billion of operating revenue and nearly $2 billion of operating income for the first half of the year. Kaiser said its operating income runs highest during the beginning of the year due to the timing of its health plan’s open enrollment”
  • Healthcare Dive tells us,
    • “Major for-profit hospital chains reported lower-than-expected volumes in second quarter earnings results, causing some to cut back on volume and earnings expectations for the year.
    • “Executives at the for-profit hospital chains — HCA Healthcare, Tenet Healthcare, Community Health Systems and Universal Health Services — attributed the volumes to different factors, from lower Medicaid admissions to a decline in consumer confidence, which impacted spending on healthcare services. 
    • “Softer volumes caused HCA, Tenet and CHS to lower their full-year outlooks for admissions. UHS did not report expectations for volume growth.”
  • Here are links to Kaufmann Hall’s June 2025 flash reports on hospitals and physicians, both of which were released today.
  • Beckers Hospital Review points out CMS’s 290 five star and 229 one star hospitals.
    • “Every year, CMS assigns star ratings to U.S. hospitals based on 46 hospital quality measures, which are divided into five categories: mortality, safety, patient experience, readmission rates, and timely and effective care. Data reporting periods range from July 2020 to December 2024, depending on the measure. The ratings were updated in July and released Aug. 6.” “
  • The American Journal of Managed Care informs us,
    • “Prescribing semaglutide in routine clinical practice was associated with meaningful—but smaller than seen in clinical trials—improvements in cardiovascular risk factors, along with an unexpected rise in non-drug health care spending, according to a new study published in JAMA Network Open.1
    • “Analyzing data from more than 23,500 adult patients across Yale New Haven Health System and Sentara Healthcare, researchers found that patients experienced an average 3.8% reduction in body weight and significant reductions in blood pressure (–1.5 mm Hg for diastolic; –1.1 for systolic), total cholesterol (–12.8 mg/dL), and hemoglobin A1c (HbA1C) at 13 to 24 months following their first semaglutide prescription. However, during the same time period, monthly health care expenditures rose by $80 per patient, not including the cost of semaglutide itself.
    • “These findings highlight a disconnect between clinical benefits and short-term cost savings, warranting caution when extrapolating trial-based projections to clinical settings,” the researchers said.”

Weekend update

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

From Washington, DC

  • Congress continues on its August recess until September 2.
  • The New York Times offers a health insurance guide for young adults coming off of their parents’ employer sponsored health plan who do have their own employer sponsored coverage.
  • The New York Times article assumes that the adult children work for a large employer (typically 50 employees or more, such as FEHBA, then the employer will pay the insurer flat rates for each enrollment tier. If, however, the parents work for a smaller employer (typically under 50 employees), the employer must pay the insurer an age adjusted premium for each covered family member.

From the HHS agencies front,

  • STAT News reports,
    • “A gunman attacked the main campus of the Centers for Disease Control and Prevention in Atlanta on Friday, further shaking an agency in the midst of a tumultuous year.
    • “One police officer died in the shooting. Atlanta police said the shooter was killed and there was no ongoing threat in a release at 6:40 p.m.
    • “Susan Monarez, the agency’s director, who was sworn in just last week, said in a post on X that the agency was working with federal, state, and local law enforcement to investigate the shooting.
    • “Our top priority is the safety and well-being of everyone at CDC,” Monarez wrote.”
  • BioPharma Dive tells us,
    • “Vinay Prasad will return to lead the Food and Drug Administration office that oversees vaccines and gene therapy in a stunning reversal that comes less than two weeks after he abruptly left the job. 
    • “Andrew Nixon, a spokesperson for the Department of Health and Human Services, confirmed Prasad’s return in an emailed statement Saturday. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center of Biologics Evaluation and Research,” Nixon wrote.
    • “The news was reported earlier by Endpoints News and Stat news. 
    • “Prasad’s return marks the latest dramatic twist in what’s already been a tumultuous run leading CBER, which in addition to vaccines and some genetic medicines also reviews blood products.” 

From the public health and medical research front,

  • NPR Shots informs us,
    • “A new federal report finds that the percentage of adults with suicidal thoughts and attempts remained about the same between 2021 and 2024.
    • “But the analysis of the National Survey on Drug Use and Health did offer some good news: Over that same time period, depression and suicidal thoughts and behaviors in teens declined.
    • “I think it’s very promising, and we’re very hopeful about it,” says Jill Harkavy-Friedman, senior vice president of research at the American Foundation for Suicide Prevention.” * * *
  • The Wall Street Journal reports
    • “The author ignored pain, thinking it was nothing, due to recent surgeries and not wanting to burden family.
    • “After experiencing severe symptoms, the author went to the ER and was diagnosed with pulmonary embolisms.
    • “The author is recovering with blood thinners and lifestyle changes, grateful to have taken symptoms seriously.”
  • On’e of the author’s experts describes blood clots as the people’s disease.
    • “About 900,000 people are diagnosed with blood clots—deep vein thrombosis or pulmonary embolism—in the U.S. each year, according to the American Lung Association. For many, the first symptom is sudden death.
    • “I call it the people’s disease. It doesn’t spare anyone—rich, poor, male, female,” says Dr. Parth Rali, director of the pulmonary embolism response team at Temple University Health System in Philadelphia, who wasn’t involved in my care. “You could be the healthiest person in the world and unfortunately it can still happen to you.”
  • Following up on a superagers study discussed in the FEHBlog, the New York Times informs us,
    • “Scientists at Northwestern University have been studying this remarkable group since 2000, in the hopes of discovering how they’ve avoided typical age-related cognitive decline, as well as more serious memory disorders like Alzheimer’s disease. A new review paper published Thursday summarizes a quarter century of their findings.
    • “Super-agers are a diverse bunch; they don’t share a magic diet, exercise regimen or medication. But the one thing that does unite them is “how they view the importance of social relationships,” said Sandra Weintraub, a professor of psychiatry and behavioral sciences at the Northwestern Feinberg School of Medicine, who has been involved in the research since the start. “And personality wise, they tend to be on the extroverted side.”
    • “This doesn’t surprise Ben Rein, a neuroscientist and the author of the forthcoming book, “Why Brains Need Friends: The Neuroscience of Social Connection.”
    • “People who socialize more are more resistant to cognitive decline as they get older,” Dr. Rein said. And, he added, they “have generally larger brains.”

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “Chicago-based Weiss Memorial Hospital closed the morning of Aug. 8 amid CMS’ plan to terminateits Medicare program participation, Huy Nguyen, chief of staff for state Rep. Hoan Huynh of the 13th District, where Weiss Memorial is located, confirmed with Becker’s.
    • “IDPH is aware that Weiss Memorial Hospital has suspended operations and we continue to monitor the situation closely,” a spokesperson for the Illinois Department of Public Health said in an Aug. 8 statement shared with Becker’s. “There were no patients hospitalized at Weiss at the time this took effect. IDPH is committed to ensuring patient safety and quality of care at healthcare facilities in Illinois, and we continue to assess the impact of this on the local healthcare system.”
    • “CMS said in a late July public notice that Medicare will stop reimbursing the 239-bed acute care hospital for inpatient care delivered to patients admitted on or after Aug. 9 due to it being out of compliance with federal standards with respect to emergency services, nursing services and physician environment.” * * *
    • “The closure of Weiss Memorial comes amid a slew of Chicago hospital closures over the last few years.
    • “In 2022, Chicago Policy Review reported that 20 hospitals have closed in the city since 2000, accounting for nearly one-fourth of its hospitals. Most recently, Ascension St. Elizabeth in Chicago closed in mid-February prior to Ontario, Calif-based Prime Healthcare’s purchase of it and eight other St. Louis-based Ascension hospitals in Illinois.” 
  • BioPharma Dive points out,
    • “Arvinas may soon be looking for a new partner for a breast cancer medicine awaiting Food and Drug Administration approval after years of working with Pfizer, as company executives revealed Wednesday [August 6] that the partners are reworking their existing deal.
    • “The two companies first joined up in 2018, inking a potential $830 million deal to find and advance medicines that break down disease-causing proteins. In 2021, they entered another contract specifically for vepdegestrant, agreeing to a 50-50 collaboration for development and commercialization.
    • “Arvinas and Pfizer had hoped that the medicine could be used as an adjuvant first-line therapy and as a second-line treatment alone. But study results released earlier this year suggest that the drug only benefits a subset of breast cancer patients with a specific mutation, and the companies narrowed their focus to advancing the drug as just a second-line monotherapy.” 
  • HR Dive notes,
    • “U.S. salary budget increases are expected to stay put at 3.5% in 2026, down just 0.1% from 2025, signaling a cooling talent market, as well as increased budgetary pressure on employers, according to data published Thursday by compensation vendor PayScale.
    • “Equal shares of employers said they would either raise or lower their budgets compared to this year, PayScale said. Among those who expected an increase, many cited the rising cost of labor. Approximately two-thirds of those who expected a decrease in their budgets cited concern about economic conditions or business performance.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • NextGov/FCW tells us,
    • “The Senate confirmed Sean Cairncross to serve as national cyber director in a 59-35 vote on Saturday night [August 2], making him the first Senate-approved cybersecurity official of President Donald Trump’s second term.
    • “Cairncross is a former Republican National Committee official and was CEO of the Millennium Challenge Corporation agency during Trump’s first term. As national cyber director, he will be tasked with overseeing an office first stood up under the Biden administration, which serves as the key White House cyber policy interlocutor across federal agencies and Capitol Hill.” 
  • Cyberscoop adds,
    • “Sean Cairncross took his post this week as national cyber director at what many agree is a “pivotal” time for the office, giving him a chance to shape its future role in the bureaucracy, tackle difficult policy issues, shore up industry relations and take on key threats.
    • “The former White House official, Republican National Committee leader and head of a federal foreign aid agency became just the third Senate-confirmed national cyber director at an office (ONCD) that’s only four years old. He’s the first person President Donald Trump has assigned to the position after the legislation establishing it became law at the end of his first term.”
  • Cybersecurity Dive informs us,
    • “The Cybersecurity and Infrastructure Security Agency [CISA] has continued its work to protect federal networks and support critical infrastructure providers despite massive job cuts and resource constraints, two senior CISA officials said during the Black Hat USA cybersecurity conference here Thursday.
    • “We are not retreating, we’re advancing in a new direction,” CISA CIO Robert Costello said during a panel discussion.
    • “Chris Butera, the acting head of CISA’s Cybersecurity Division, added that, while the agency “did lose people” to the Trump administration’s downsizing program — roughly a third of its employees — CISA still has “a very talented workforce.” He cited the agency’s around-the-clock response to major vulnerabilities in Microsoft SharePoint as an example of CISA’s continued capacity.”
  • and
    • “The U.S. government is still pushing agencies to adopt zero-trust network designs, continuing a project that gained steam during the Biden administration, a senior cybersecurity policy official said on Wednesday.
    • “It must continue to move forward,” Michael Duffy, the acting federal chief information security officer, said during a panel at the Black Hat cybersecurity conference. “That architectural side of it is very important for us to get right as we integrate new technologies [like] artificial intelligence into the ways we operate.”
    • “Zero-trust networking emphasizes the concept of throwing up hurdles to hackers who penetrate a computer system, limiting the damage they can do by sealing off parts of the network and requiring strict user authentication.”
  • Per Dark Reading,
    • “As the Department of Defense (DoD) continues to make deeper strides in implementing its Cybersecurity Maturity Model Certification (currently CMMC 2.0), we find ourselves at the cusp of what feels like its next iteration, CMMC 3.0, marking the next evolution in its efforts to strengthen cybersecurity across the defense industrial base (DIB). While the updated framework builds on the structure of CMMC 2.0, this new update would include clearer expectations and stricter enforcement, particularly for organizations handling controlled unclassified information (CUI). The DoD’s message is clear: Reducing risk and enhancing resilience are now mission-critical for any company supporting national defense.”
  • Cybersecurity Dive adds,
    • “The Chinese government has such vast hacking resources that it’s targeting tiny companies in the U.S. defense industrial base that never imagined they would end up on Beijing’s radar, a National Security Agency official said here Wednesday.
    • “China’s hacking resources outnumber those of the U.S. and [its] allies combined, and China has stolen more corporate data from the United States than any other nation in the world,” Bailey Bickley, chief of DIB defense at the NSA’s Cybersecurity Collaboration Center, said during a session at the Black Hat USA cybersecurity conference.
    • “Although best known for its intelligence-collection role, the NSA is also responsible for helping defense contractors safeguard their systems. Recently, the agency has been doing that through free security services — including classified information sharing and a protective DNS offering — from the Cybersecurity Collaboration Center.
    • “When we engage with small companies” in the defense industrial base, “they often think that what they do is not important enough to be targeted” by China, Bickley said. “But when you have the significant resources like that to conduct mass scanning and mass exploitation, there is no company and no target too small.”
  • and
    • “The Defense Advanced Research Projects Agency on Friday [August 8] unveiled the winners of a competition to spur the development of artificial intelligence tools designed to autonomously find and fix software vulnerabilities.
    • “Team Atlanta, Trail of Bits and Theori claimed the top three spots in DARPA’s AI Cyber Challenge, agency officials said at the DEF CON cybersecurity conference here. They will receive prizes of $4 million, $3 million and $1.5 million, respectively.
    • “All seven finalist teams will open source their AI tools so that the entire world can use them. Four of the tools debuted on Friday, while the remaining three will be released in the next few weeks.’
  • Cyberscoop reports,
    • “BlackSuit’s technical infrastructure was seized in a globally coordinated takedown operation last month that authorities touted as a significant blow in the fight against cybercrime. The ransomware group’s leak site has displayed a seizure notice since July 24.
    • “The takedown followed a long investigation, which allowed authorities to confiscate “considerable amounts of data,” and identify 184 victims, German officials said in a news release last week. The group’s total extortion demands surpassed $500 million by August 2024, with demands typically in the range of $1 million to $10 million, the Cybersecurity and Infrastructure Security Agency said in an advisory last year. 
    • “U.S. authorities were heavily involved in the operation, but have yet to share details about the investigation or its results. BlackSuit’s extortion site was seized by the Department of Homeland Security’s Homeland Security Investigation department, a unit of U.S. Immigration and Customs Enforcement. 
    • “A spokesperson for ICE told CyberScoop the Justice Department has been waiting for court documents to be unsealed before releasing any information about the law enforcement action dubbed “Operation Checkmate.” The FBI, Secret Service, Europol and cyber authorities from the United Kingdom, Germany, France, Ireland, Ukraine, Lithuania and Romania-based cybersecurity firm Bitdefender were also involved in the operation.” 
  • Dark Reading relates,
    • “Two senior executives and founders of the Samourai Wallet cryptocurrency mixer have pleaded guilty to charges involving washing more than $200 million for cybercriminals and other nefarious types.
    • “CEO Keonne Rodriguez and chief technology officer William Lonergan Hill admitted to operating a money-transmitting business that handled criminal proceeds. They have pleaded guilty to conspiracy and face a maximum sentence of five years in prison in addition to the fine.
    • “The US Department of Justice first arrested Rodriguez and Hill in April of last year on two counts of conspiracy: operating an unlicensed money-transmitting business and money laundering, the latter of which carries a maximum sentence of 20 years.”

From the cybersecurity breaches and vulnerabilities front,

  • FedScoop reports,
    • “The U.S. judiciary announced plans to increase security for sensitive information on its case management system following what it described as “recent escalated cyberattacks of a sophisticated and persistent nature.”
    • “In a Thursday [August 7] statement, the federal judiciary said it’s “taking additional steps to strengthen protections for” that information. It also said it’s “further enhancing security of the system and to block future attacks, and it is prioritizing working with courts to mitigate the impact on litigants.”
    • “The statement from the third branch comes one day after a Politico report revealed that its case filing system had recently been breached. That report cited unnamed sources who were concerned that the identities of confidential court informants may have been compromised.”
  • Cyberscoop tells us,
    • “Federal cyber authorities issued an alert Wednesday evening about a high-severity vulnerability affecting on-premises Microsoft Exchange servers shortly after a researcher presented findings of the defect at Black Hat. 
    • “Microsoft also issued an advisory about the vulnerability — CVE-2025-53786 — and said it’s not aware of exploitation in the wild. 
    • “While the public disclosure and advisories about the defect came late in the day amid one of the largest cybersecurity conferences, Tom Gallagher, VP of engineering at Microsoft Security Response Center, told CyberScoop the timing was coordinated for release following Mollema’s presentation.
    • “Gallagher stressed that exploitation requires an attacker to achieve administrative access to an on-premises Exchange server in a hybrid environment.” 
  • and
    • “SonicWall warned customers to disable encryption services on Gen 7 firewalls in the wake of an active attack spree targeting a yet-to-be identified vulnerability affecting a critical firewall service. Attacks have increased notably since Friday, the company said in a blog post.
    • “Threat hunters and incident responders from Arctic Wolf, Google and Huntress have observed a wave of ransomware attacks beginning as early as July 15. Mounting evidence points to a zero-day vulnerability affecting the secure sockets layer (SSL) VPN protocol as the initial attack vector.
    • “A financially motivated threat actor is actively compromising victim environments and deploying Akira ransomware,” Charles Carmakal, CTO at Mandiant Consulting, said in a LinkedIn post Tuesday. “The speed and scale of the compromises suggests a potential zero-day vulnerability in SonicWall Gen 7 firewalls.”
    • “SonicWall said an ongoing investigation has yet to determine if the attacks involve a previously disclosed vulnerability or a zero-day. “If a new vulnerability is confirmed, we will release updated firmware and guidance as quickly as possible,” Bret Fitzgerald, senior director of global communications at SonicWall, told CyberScoop.”
  • Per Bleeping Computer,
    • “Trend Micro has warned customers to immediately secure their systems against an actively exploited remote code execution vulnerability in its Apex One endpoint security platform.
    • “Apex One is an endpoint security platform designed to automatically detect and respond to threats, including malicious tools, malware, and vulnerabilities.
    • “This critical security flaw (tracked as CVE-2025-54948 and CVE-2025-54987 depending on the CPU architecture) is due to a command injection weakness in the Apex One Management Console (on-premise) that enables pre-authenticated attackers to execute arbitrary code remotely on systems running unpatched software.
    • “Trend Micro has yet to issue security updates to patch this actively exploited vulnerability, but it has released a mitigation tool that provides short-term mitigation against exploitation attempts.”
  • and
    • “A recently fixed WinRAR vulnerability tracked as CVE-2025-8088 was exploited as a zero-day in phishing attacks to install the RomCom malware.
    • “The flaw is a directory traversal vulnerability that was fixed in WinRAR 7.13, which allows specially crafted archives to extract files into a file path selected by the attacker.
    • “When extracting a file, previous versions of WinRAR, Windows versions of RAR, UnRAR, portable UnRAR source code and UnRAR.dll can be tricked into using a path, defined in a specially crafted archive, instead of user specified path,” reads the WinRAR 7.13 changelog.”
  • CISA added three known exploited vulnerabilities to its catalog this week.
  • Per SC Media,
    • “Dormant service accounts with privileges were found in more than 70% of enterprise environments according to new research released by BeyondTrust on Aug. 4 at BlackHat in Las Vegas.
    • “The researchers also reported that overly permissive Entra Service Principals create direct pathways to Global Admin privileges, exposing entire Microsoft 365 environments to potential takeover.
    • “According to BeyondTrust, credentials reused across multiple service accounts by human administrators can also let a single compromised password hack numerous non-human accounts.”
    • “Our data shows that many organizations lack the complete story when it comes to their identity attack surface,” said Marc Maiffret, chief technology officer at BeyondTrust. “For many, overlooked hygiene issues silently open the door to attackers. And with the rise of Agentic AI, the stakes have never been higher, especially as most organizations lack visibility into how compromised accounts can be leveraged to seize control of application secrets, which often carry elevated privileges.”
  • Security Week points out,
    • “Five vulnerabilities in the ControlVault3 firmware and the associated Windows APIs expose millions of Dell laptops to persistent implants and Windows login bypasses via physical access, Cisco Talos reports.
    • “The issues, tracked as CVE-2025-24311, CVE-2025-25215, CVE-2025-24922, CVE-2025-25050, and CVE-2025-24919, were initially disclosed on June 13, when Dell announced that patches for them were rolled out for over 100 Dell Pro, Latitude, and Precision models.
    • “The affected component, ControlVault3 (and the ControlVault3+ iteration), is a hardware-based system meant to securely store passwords, biometric information, and security codes.”

From the ransomware front,

  • Bleeping Computer reports,
    • “Ransomware gangs have recently joined ongoing attacks targeting a Microsoft SharePoint vulnerability chain, part of a broader exploitation campaign that has already led to the breach of at least 148 organizations worldwide.
    • “Security researchers at Palo Alto Networks’ Unit 42 have discovered a 4L4MD4R ransomware variant, based on open-source Mauri870 code, while analyzing incidents involving this SharePoint exploit chain (dubbed “ToolShell”).
    • “The ransomware was detected on July 27 after discovering a malware loader that downloads and executes the ransomware from theinnovationfactory[.]it (145.239.97[.]206).
    • “The loader was spotted following a failed exploitation attempt that revealed malicious PowerShell commands designed to disable security monitoring on the targeted device.
    • “Analysis of the 4L4MD4R payload revealed that it is UPX-packed and written in GoLang. Upon execution, the sample decrypts an AES-encrypted payload in memory, allocates memory to load the decrypted PE file, and creates a new thread to execute it,” Unit 42 said.”
  • and
    • “A new Endpoint Detection and Response (EDR) killer that is considered to be the evolution of ‘EDRKillShifter,’ developed by RansomHub, has been observed in attacks by eight different ransomware gangs.
    • “Such tools help ransomware operators turn off security products on breached systems so they can deploy payloads, escalate privileges, attempt lateral movement, and ultimately encrypt devices on the network without being detected. 
    • “According to Sophos security researchers, the new tool, which wasn’t given a specific name, is used by RansomHub, Blacksuit, Medusa, Qilin, Dragonforce, Crytox, Lynx, and INC.”
  • CISA issued an Analysis report about Exploitation of SharePoint Vulnerabilities on August 6.
  • InfoSecurity Magazine explains how ransomware actors have expanded tactics beyond encryption and exfiltration.
  • Halcyon warns us,
    • “Ransomware remains one of the most destructive and expensive threats facing organizations today. With average ransom demands hitting $3.5M, victims are forced into high-stakes decisions under intense pressure: pay up or risk catastrophic disruption. 
    • “Nearly half of all targeted organizations end up paying, even after negotiations. The impact doesn’t end with encryption: recovery takes weeks, services stall, regulators circle, and trust erodes. Ransomware isn’t just a cybersecurity problem; it’s a full-blown operational crisis.  
    • “The Halcyon team of ransomware experts has put together this extortion group power rankings guide as a quick reference for the extortion threat landscape based on data from throughout Q2-2025, which can be reviewed along with earlier reports here: Power Rankings: Ransomware Malicious Quartile.”
  • MSPP Alert adds,
    • “Ransomware doesn’t play fair—and now, neither are the defenders. Sophos and Halcyon are teaming up with a direct integration that goes far beyond traditional intel feeds or industry sharing forums. This partnership isn’t about exchanging threat data after the fact. It’s about coordinating active defenses in real time, within live customer environments.
    • “What makes this different? According to Simon Reed, Chief Research and Scientific Officer at Sophos, it’s not just another “threat feed” dropped into a dashboard. “Sophos and Halcyon’s approach to threat intelligence sharing shifts the status quo from out-of-context threat intelligence (which is still hugely useful as an industry standard approach) to sharing coordinated, real-time defense that meets attackers head-on,” he told MSSP Alert.
    • “Instead of piecing together siloed signals, both companies are now synchronizing responses against a common adversary.”

From the cybersecurity business and reporting front,

  • Dark Reading reports,
    • “It was a memorable Black Hat 2025 USA for the founders of Prime Security, the winners of this year’s Startup Spotlight competition.
    • “The Startup Spotlight Competition is a pitch competition for cybersecurity startup companies to present their products and solutions in front of a live audience at Black Hat. In the first phase of the competition, startups of all stripes submitted a pitch describing the company and the products and solutions. A panel of judges reviewed submissions for the competition, looking for companies that fit the bill of “most innovative emerging companies in cybersecurity,” before narrowing down to four: FireTail, Keep Aware, Prime Security, and Twine Security. 
    • “Representatives from each of the four companies pitched their companies and products for the final time to a panel of judges at the Black Hat USA conference in Las Vegas, in a Shark Tank-style competition. While the judges deliberated on the winner, the audience also voted on their favorite. Prime Security won both the judges’ votes as well as the audience’s.”
  • Here is a link to Dark Reading’s round up of Black Hat conference news.
  • Also per Dark Reading,
    • “Investing in building a human-centric defense involves a combination of adaptive security awareness training, a vigilant and skeptical culture, and the deployment of layered technical controls.”
  • and
    • “Data Dump from APT Actor Yields Clues to Attacker Capabilities. The tranche of information includes data on recent campaigns, attack tools, compromised credentials, and command files used by a threat actor believed to be acting on behalf of China or North Korea.”

Door prize from the artificial intelligence front

  • Per Security Week,
    • “Red Teams Jailbreak GPT-5 With Ease, Warn It’s ‘Nearly Unusable’ for Enterprise
    • “Researchers demonstrate how multi-turn “storytelling” attacks bypass prompt-level filters, exposing systemic weaknesses in GPT-5’s defenses.”