Cybersecurity Saturday

David Ermer

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

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Federal News Network tells us,
    • “The House Homeland Security Committee plans to convene in early September to mark up a reauthorization bill for a soon-to-expire cybersecurity law that’s viewed as critical to cyber collaboration across government and industry.
    • “In a statement, House Homeland Security Committee Chairman Andrew Garbarino (R-N.Y.) confirmed the committee will mark up a reauthorization bill for the Cybersecurity Information Sharing Act of 2015 once Congress returns from August recess.
    • “Reauthorizing the Cybersecurity and Information Sharing Act is essential as the deadline nears and as threats evolve,” Garbarino said. “The House Committee on Homeland Security plans to mark up our legislative text for its reauthorization shortly after Congress returns from recess in September. In a 10-year extension, I will preserve the privacy protections in the law, and I aim to provide enhanced clarity to certain pre-existing provisions to better address the evolving threat landscape.”
    • “CISA 2015, as it’s known, expires at the end of September. The law provides liability protections and privacy guardrails to especially encourage private sector organizations to voluntarily share data with each other and government agencies.”
  • Cybersecurity Dive reports,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) has updated its recommendations for the minimum features of a software bill of materials (SBOM), the latest step in the agency’s campaign to encourage transparency in the software market.
    • “The updates and additions included in this document will better position Federal Government agencies and other SBOM consumers to address a range of use cases, understand the generation process, and improve data quality,” CISA said in the new publication, which it released on Thursday [August 21].” * * *
    • “The publication, which is open for public comment through Oct. 3, is aimed primarily at government agencies but is also designed to help other organizations understand what to expect from their vendors’ SBOMs.”
  • and
    • “The National Institute of Standards and Technology [NIST] wants public feedback on a plan to develop guidance for how companies can implement various types of artificial intelligence systems in a secure manner. 
    • “NIST on Thursday [August 14] released a concept paper about creating control overlays for securing AI systems based on the agency’s widely used SP 800-53 framework. The overlays are designed to help ensure that companies implement AI in a way that maintains the integrity and confidentiality of the technology and the data it uses in a series of different test cases. 
    • “The agency also created a Slack channel to collect community feedback on the development of the overlays.”
  • Per NIST news releases,
  • and
    • “NIST has released the initial public draft (IPD) of Special Publication (SP) 1331, Quick-Start Guide for Using CSF 2.0 to Improve the Management of Emerging Cybersecurity Risks, for public comment. The document highlights the topic of emerging cybersecurity risks and explains how organizations can improve their ability to address such risks through existing practices within the cyber risk discipline in conjunction with the NIST Cybersecurity Framework (CSF) 2.0. The guide also emphasizes the importance of integrating these practices with organizational enterprise risk management (ERM) to proactively address emerging risks before they occur. 
    • “The comment period is open through September 21, 2025, at 11:59 PM. Please send your feedback about this draft publication to csf@nist.gov.”
  • Per an HHS news release,
    • “Today [August 18], the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with BST & Co. CPAs, LLP (“BST”), a New York public accounting, business advisory, and management consulting firm, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. BST is a HIPAA business associate and receives financial information that also contains protected health information (PHI) from a HIPAA covered entity.” * * *
    • “The settlement resolves an investigation of BST that OCR initiated after receiving a breach report that BST filed on February 16, 2020. BST reported that on December 7, 2019, BST discovered that part of its network was infected with ransomware, impacting the PHI of its covered entity client. OCR’s investigation determined that BST had failed to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by BST.
    • “Under the terms of the resolution agreement, BST agreed to implement a corrective action plan that will be monitored by OCR for two years and paid $175,000 to OCR.”
  • Cybersecurity Dive informs us,
    • “Federal prosecutors on Tuesday [August 19] charged an Oregon man for allegedly running a global botnet-for-hire operation called Rapper Bot that used hacked IoT devices to conduct large-scale distributed denial-of-service (DDoS) attacks.
    • “Authorities charged Ethan Foltz, 22, with one count of aiding and abetting computer intrusions. Police executed a search warrant at Foltz’s house on Aug. 6, shut down the botnet and took control of its infrastructure, according to the U.S. Department of Justice.
    • “Rapper Bot allegedly used between 65,000 and 95,000 infected devices for DDoS attacks that often measured between two and three terabits per second. The largest attack may have exceeded six terabits per second, prosecutors said.
    • “Rapper Bot was “one of the most powerful DDoS botnets to ever exist,” said Michael Heyman, the U.S. attorney in Alaska, where authorities believe the botnet infected at least five devices.”
  • Cyberscoop adds,
    • “A 20-year-old Florida man received a 10-year federal prison sentence Wednesday for his role in the notorious Scattered Spider cybercrime organization, marking the first conviction of a member from the group responsible for breaching more than 130 major companies.
    • “Noah Michael Urban, 20, of Palm Coast, Fla., pleaded guilty to conspiracy, wire fraud and aggravated identity theft charges in two separate federal cases spanning Florida and California. A federal judge sentenced Urban to 120 months in prison with three years of supervised release and ordered him to pay $13 million in restitution to victims.
    • “The sentence exceeded federal prosecutors’ recommendation of eight years, reflecting the scope of Urban’s criminal activities that investigators say caused between $9.5 million and $25 million in total losses.”

From the cybersecurity vulnerabilities and breaches front,

  • The American Hospital Association News informs us,
    • “The FBI Aug. 20 released an advisory warning of malicious activity by Russian cyber actors targeting end-of-life devices running an unpatched vulnerability in Cisco Smart Install software. The agency said the actors, attributed to the Russian Federal Security Service’s Center 16, have been detected collecting configuration files for thousands of networking devices associated with U.S. entities across critical infrastructure sectors. On some devices, the files were modified to enable unauthorized access to the devices. The vulnerability was initially publicized in 2018.
    • “If you have vulnerable equipment in your network, please pay particular attention to ensuring that it is patched and running as securely as possible,” said Scott Gee, AHA deputy national advisor of cybersecurity and risk. “It is recommended that hospitals also make this equipment a priority for replacement since it’s no longer supported for updates by Cisco. It is also a good time to review the process for patch management and equipment upgrades, particularly focusing on patching known exploited vulnerabilities. The Cybersecurity Infrastructure and Security Agency maintains a catalog of KEVs.”
  • CISA added two known exploited vulnerabilities to that catalog this week.
  • Cyberscoop adds,
    • “The Chinese state-backed threat group Silk Typhoon has raised the pace of attacks targeting government, technology, legal and professional services in North America since late spring, according to CrowdStrike.
    • “We were calling this jokingly, ‘the summer of Murky Panda,’ because we’ve seen so much activity from them over the last couple of months,” said Adam Meyers, senior vice president of counter adversary operations at CrowdStrike, using the firm’s nomenclature for the cyberespionage group.
    • “CrowdStrike has worked on more than a dozen cases involving Murky Panda during the past few months, including two active incident response cases, Meyers said. The group, which has been active since at least 2023, is “one of the top-tier Chinese threats that we’ve been seeing a lot this summer,” he said.
    • “Murky Panda exemplifies how Chinese attackers are gaining access to victim networks and infrastructure via vulnerabilities, unmanaged devices, the cloud and pivots between cloud services. 
    • “The group’s advanced techniques in cloud environments are evident, as it enables prolonged access and lateral movement to downstream victims by abusing delegated administrative privileges in cloud solution providers, CrowdStrike said in a research report released Thursday. [August 21].
  • Bleeping Computer reports,
    • “Hackers have stolen the personal information of 1.1 million individuals in a Salesforce data theft attack, which impacted U.S. insurance giant Allianz Life in July.
    • “Allianz Life has nearly 2,000 employees in the United States and is a subsidiary of Allianz SE, which has over 128 million customers worldwide and ranks as the world’s 82nd largest company based on revenue.
    • “As the company disclosed last month, information belonging to the “majority” of its 1.4 million customers was stolen by attackers who gained access to a third-party cloud CRM system on July 16th.” * * *
    • “On Monday, data breach notification service Have I Been Pwned revealed the extent of the incident, reporting that the email addresses, names, genders, dates of birth, phone numbers, and physical addresses of 1.1 million Allianz Life customers were stolen during the breach.
    • “Bleeping Computer has also confirmed with multiple people affected by this breach that their data (including their tax IDs, phone numbers, email addresses, and other information) in the leaked files is accurate.
    • “Many other high-profile companies worldwide were also breached in this campaign, including Google, Adidas, Qantas, Louis Vuitton, Dior, Tiffany & Co., Chanel, and, most recently, human resources giant Workday.”
  • Cybersecurity Dive notes,
    • The attack [on WorkDay] follows a string of social-engineering intrusions linked to ShinyHunters, a hacker group associated with an underground cybercrime collective known as The Com. The Com also has ties to the notorious hacker team Scattered Spider, which has targeted companies in multiple industries over the past several months, including retail, insurance and aviation. 
    • ShinyHunters has launched numerous attacks in recent months targeting Salesforce instances, according to researchers at Google. The group targeted one of Google’s own Salesforce instances earlier this month. 
    • Reliaquest recently published evidence of possible collaboration between ShinyHunters and Scattered Spider, including ticket-themed phishing domains and Salesforce credential-harvesting pages. 
  • Per Dark Reading,
    • “In this interview from Black Hat USA 2025, Philippe Laulheret, a senior vulnerability researcher at Cisco Talos, discusses his discovery of the “ReVault” vulnerability affecting millions of Dell business laptops. 
    • “Laulheret found that the Control Vault (also called a unified secure hub) — a control board connecting peripherals like fingerprint readers and smart card readers to Dell Latitude and Precision laptops — contained multiple security flaws that allow any user to communicate with the board through undocumented APIs, potentially leading to memory corruption, code execution, extraction of secret keys, and permanent firmware modification.”
  • Per Bleeping Computer,
    • “Six major password managers with tens of millions of users are currently vulnerable to unpatched clickjacking flaws that could allow attackers to steal account credentials, 2FA codes, and credit card details.
    • “Threat actors could exploit the security issues when victims visit a malicious page or websites vulnerable to cross-site scripting (XSS) or cache poisoning, where attackers overlay invisible HTML elements over the password manager interface.
    • “While users believe they are interacting with harmless clickable elements, they trigger autofill actions that leak sensitive information.
    • “The flaws were presented during the recent DEF CON 33 hacker conference by independent researcher Marek Tóth. Researchers at cybersecurity company Socket later verified the findings and helped inform impacted vendors and coordinate public disclosure.
    • “The researcher tested his attack on certain versions of 1Password, Bitwarden, Enpass, iCloud Passwords, LastPass, and LogMeOnce, and found that all their browser-based variants could leak sensitive info under certain scenarios.”
  • and
    • “A new infostealer malware targeting Mac devices, called ‘Shamos,’ is targeting Mac devices in ClickFix attacks that impersonate troubleshooting guides and fixes.
    • “The new malware, which is a variant of the Atomic macOS Stealer (AMOS), was developed by the cybercriminal group “COOKIE SPIDER,” and is used to steal data and credentials stored in web browsers, Keychain items, Apple Notes, and cryptocurrency wallets.
    • “CrowdStrike, which detected Shamos, reports that the malware has attempted infections against over three hundred environments worldwide that they monitor since June 2025.”

From the ransomware front,

  • Cybersecurity Dive reports on August 20,
    • “The pharmaceutical and biotechnology company Inotiv Inc. is investigating a cyberattack that led to hackers encrypting the firm’s data, it said in a filing on Monday with the U.S. Securities and Exchange Commission. 
    • “The Aug. 8 attack disrupted access to certain data storage and business applications, according to Innotiv. The company said it is working to bring certain systems back online and has moved some operations to offline alternatives in order to maintain business continuity.  
    • The company has restricted access to its systems, retained third-party experts and notified law enforcement, according to its SEC filing.” * * *
    • “The hackers behind the Qilin ransomware have claimed credit for the attack, according to researchers at Huntress and Kroll.”
  • Bleeping Computer adds on August 22,
    • “Kidney dialysis firm DaVita has confirmed that a ransomware gang that breached its network stole the personal and health information of nearly 2.7 million individuals.
    • “DaVita serves over 265,400 patients across 3,113 outpatient dialysis centers, 2,660 in the United States, and 453 centers in 13 other countries worldwide. The company reported revenues of over $12 billion in 2024 and of $3.3 billion for the second quarter of 2025.
    • “In April, the healthcare provider revealed in a filing with the U.S. Securities and Exchange Commission (SEC) that its operations were disrupted after attackers partially encrypted its network over the weekend.
    • “According to a dedicated website with more information regarding the resulting data breach, the attackers gained access to DaVita’s network on March 24 and were evicted after the company detected the incident on April 12.” * * *
    • “Although the kidney dialysis firm hasn’t linked the attack to a specific ransomware operation, the Interlock ransomware gang claimed responsibility for the breach in late April.
    • “Interlock also leaked the allegedly stolen data on its dark web portal after negotiations with DaVita had failed, claiming it had stolen roughly 1.5 terabytes of data from the company’s compromised systems, or nearly 700,000 files containing what appeared to be sensitive patient records, insurance details, user account information, and financial data.”
  • Dark Reading points out that “Researchers highlight how Warlock, a new ransomware heavyweight, uses its sophisticated capabilities to target on-premises SharePoint instances.”

From the cybersecurity business and defenses front,

  • Cybersecurity Dive reports,
    • “Enterprise software spending will sustain double-digit growth through 2029, according to Forrester projections. Vendor revenues grew 11% on average during the first quarter of the year, the analyst firm said in a July report.
    • “Infrastructure software spend will lead the charge, increasing 13.3% over the next four years, as enterprises stock up on cloud services, security tools and AI capabilities. The market for application software, a category that includes IT operations management, enterprise resource planning, and supply chain tools, will see slower growth of 9.5%, the firm said.
    • “Database management services will help shore up software market growth, as enterprises lay the groundwork for generative AI and agentic automation tools. The firm previously estimated off-the-shelf AI governance software spend to more than quadruple from 2024 to 2030, nearing $16 billion and capturing 7% of the software market.”
  • and
    • “Many business leaders still aren’t following cybersecurity best practices to protect their organizations from costly intrusions, according to a report that the consulting giant Unisys published on Tuesday [August 21].
    • “Only 62% of organizations have or are setting up a zero-trust network architecture, only 61% are prioritizing post-incident recovery and only 45% deploy or plan to deploy managed detection and response software.
    • “Only 42% of organizations said they use or plan to use digital identity and access management services, which are considered essential for stopping attacks that exploit legitimate credentials.”
  • Dark Reading informs us,
    • “Cyber insurers are testing out new ways to hold policyholders accountable for outdated security, limiting payouts when policyholders fall prey to attacks that use older vulnerabilities or take advantage of holes in the organizations’ defenses.
    • “Potential risk-limiting approaches include a sliding scale of accountability — and payouts — based on an unpatched vulnerability’s half-life, or whether a company failed to fix a critical vulnerability within a certain number of days, according to a blog post penned by cyber insurer Coalition, which does not support such approaches. Dubbed CVE exclusions, after the Common Vulnerabilities and Exposures (CVE) system widely used to assign identifiers to software security issues, the tactic is not yet widely adopted, and most examples are from insurers outside the US, the firm stated.
    • The limits could start showing up in companies’ policies, however, if demand for cyber insurance continues to grow, creating a seller’s market, says John Coletti, head of cyber underwriting at Coalition
    • “While we will not name names, there are specific examples of this occurring within the industry,” he says. “A company should be highly skeptical of buying a policy with a CVE exclusion.”
  • Info-Security Magazine relates,
    • “The US National Institute of Standards and Technology (NIST) has published new guidelines it claims will help organizations optimize their efforts to detect face morphing software.
    • “Face morphing is a type of deepfake technology that enables threat actors to blend the photos of two people into a single image. In doing so, it simplifies identity fraud by tricking face recognition systems into erroneously identifying an image as belonging to both original individuals.
    • “In this way, individual A can assume the identity of individual B and vice versa, NIST said.
    • “The new report, Face Analysis Technology Evaluation (FATE) MORPH 4B: Considerations for Implementing Morph Detection in Operations (NISTIR 8584), offers an introduction to the topic and key detection methods.
    • “It focuses mainly on the pros and cons of various investigatory techniques, and ways to prevent morphs from entering operational systems in locations such as passport application offices and border crossings.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

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

From Washington, DC,

  • Here is a link to the OPM Director’s weekly blog post.
    • “Of course, government doesn’t – and shouldn’t – function like private entrepreneurship. We can’t shoot for the moon and embrace unbridled risk as do venture-backed startups. But government can embrace a growth mindset – not leaving good enough alone, but instead always thinking about ways in which we can improve operational efficiency, try new things, and embrace change.”
  • Govexec reports,
    • “President Trump has just nine days to issue his likely plan to freeze federal employees’ salaries in 2026, before sizeable automatic and across-the-board increases take hold.
    • “Each August, the president must issue an alternative pay plan, declaring an economic emergency to avert the automatic implementation of sizeable increases to locality pay due to the 1990 Federal Employees Pay Comparability Act. Administrations of both parties have bemoaned the way that the law calculates those automatic adjustments, hence the annual sidestep of that provision.”
  • and
    • “The Internal Revenue Service is no longer planning to pursue layoffs as it seeks to rebuild parts of its workforce. The tax agency is now working to plug staffing holes with hiring, reassignments and rescinding the administration’s deferred resignation offer for some employees upon finding mission-critical staffing gaps. 
    • “The decision to forgo layoffs, confirmed by two sources briefed on the matter, marks a significant reversal for an agency that has shed about a quarter of its staff and had earlier this year planned to issue widespread reductions in force.”
  • Per a National Institutes of Health news release,
    • “I [NIH Director Jay Bhattacharya, MD] am pleased to announce the release of NIH’s new plan to promote gold standard science across all agency activities. Building on NIH’s longstanding commitment to scientific integrity, this forward-looking plan incorporates the nine, interlocking tenets of gold standard science adopted by the U.S. Government and aligns with the Department of Health and Human Services’ framework for achieving these principles.”
  • STAT News lets us know,
    • “The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting System, was updated quarterly. 
    • “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public,” FDA Commissioner Marty Makary said in a statement. “We’re closing that waiting period and will continue to streamline the process from start to finish.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal court in Maryland has blocked [Dropbox link to opinion] several parts of a health insurance exchange enrollment and eligibility rule days before they were set to take effect.
    • “The U.S. District Court for the District of Maryland temporarily stayed seven provisions from a Centers for Medicare and Medicaid Services rule issued June 20 and set to go live Monday.
    • “Judge Brendan Herson’s Friday ruling temporarily blocks a $5 premium penalty on auto-reenrollments, along with a policy disqualifying people for advance payment of subsidies if they didn’t file income taxes and failed to reconcile their tax credits in a previous year. 
    • “It also stops regulators from eliminating guaranteed insurance coverage for individuals with past-due premiums and pauses a requirement that exchanges verify certain household income data.
    • “Also on pause are policies to require pre-enrollment eligibility checks ahead of a special enrollment period and a change to the formula used to calculate plan tiers. 
    • “The ruling allows CMS’ methodology for calculating premium adjustments, along with its elimination of a 60-day window for enrollees to resolve household income data, to go forward. 
    • “The court did not weigh in on other provisions in the regulation, such as the shorter open enrollment period. Plaintiffs are not contesting the changes to the low-income enrollee signup period.”

From the public health and medical research front,

  • The Centers for Disease Prevention 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 and highest in young children. COVID-19 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.
    • “Vaccination
      • “Research finding: An MMWR report released August 21, 2025, found that in the first RSV season (2023–24) where RSV prevention products were available, 29% of infants born during October 2023–March 2024 were immunized against RSV through receipt of nirsevimab (a monoclonal antibody) or maternal RSV vaccination during pregnancy. The report used data from immunization information systems representing 33 states and the District of Columbia. State-specific immunization coverage ranged from 11% to 53%. Preliminary data from the 2024–25 season suggested that RSV immunization coverage increased nationally.
      • “The recent FDA approval and CDC recommendation for an additional monoclonal antibody, clesrovimab, could further increase access and immunization coverage for infants in the 2025–26 respiratory virus season. RSV immunization products will be available beginning in September for most of the continental United States.”
  • The University of Minnesota’s CIDRAP adds,
    • “Emergency department (ED) visits for COVID, still at low levels, also rose, up 15.2% compared to the previous week. Levels are higher in the South, Southeast, and West compared with other parts of the country. The CDC said ED visits are rising for all age groups and are highest in young children.
    • “Hospitalization rates have shown a slight upward trend since July, and the rate of deaths from COVID remains low with no change reported compared with the previous week. 
    • “Due to technical issues, the CDC did not report wastewater data for COVID, influenza A, or respiratory syncytial virus (RSV) today and said it would resume updates as soon as possible. Last week, it said the overall detection level was low and highest in the West.”
  • and
    • “The Kansas Department of Health and Environment (KDHE) yesterday announced the end of a large measles outbreak in the southwestern part of the state, after two incubation periods passed with no new cases.” * * *
    • “Elsewhere, the Wisconsin Department of Health Services and Oconto County Public Health have identified five more measles infections linked to nine earlier cases reported from Oconto County in early August, bringing the total to 14. 
    • “Officials said the ongoing investigation indicates that measles is spreading locally. Oconto County is located in northeastern Wisconsin and is part of the Green Bay area.
    • “In other measles developments, the Pennsylvania Department of Health yesterday issued an alert about potential measles exposures in four counties after an out-of-state traveler visited the state while contagious. The exposures occurred in Adams, Clearfield, Lancaster, and York counties. Locations included two Mennonite facilities, along with a travel center, a restaurant, and an entertainment venue.”
  • Genetic Engineering and Biotechnology tells us,
    • In neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Parkinson’s, and Alzheimer’s, healthy brain cells are damaged by aberrant reactive oxygen species (ROS). A potential treatment involves neutralizing ROS using antioxidant drugs. But these approaches failed to penetrate the brain effectively or proved unstable or indiscriminately damaged healthy cells. 
    • Now, a new study led by scientists at the Institute for Basic Science (IBS) in Daejeon, South Korea explores how the brain defends itself against hydrogen peroxide, a particularly harmful ROS. Using advanced imaging and molecular analysis, they discovered that hemoglobin exists in the nucleolus of astrocytes, where it acts as a “pseudoperoxidase” that breaks down H₂O₂ into harmless water. Full details are published in a new Signal Transduction and Targeted Therapy paper titled “Hemoglobin as a pseudoperoxidase and drug target for oxidative stress-related diseases.”
    • “The key was to uncover hemoglobin’s antioxidant potential in the brain and design a ‘first-in-class’ compound that could selectively enhance it,” said Won Woojin, PhD, first author on the study. “By boosting a natural defense mechanism rather than introducing an external antioxidant, we achieved strong and lasting protection across multiple disease models associated with oxidative stress.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Pittsburgh-based insurer Highmark brought in $16.5 billion in revenue for the first half of 2025, leaning on its health system and other diversified businesses as headwinds batter its payer unit.
    • “That includes $121 million in operating income and $329 million in net income for the first six months of the year. As of June 30, the company had $10.3 billion in net assets.
    • “The midyear financial results reflect an ongoing rebound at Allegheny Health Network, Highmark’s health system. The AHN posted $2.8 billion in revenue and $72 million in operating income for the first half of the year, bolstered by significant improvements to volumes across multiple categories.
    • “In the first half of the year, inpatient discharges and observations were up by 4% and outpatient registrations were up by 5% compared to the first six months of 2024. The AHN also saw a 7% increase in physician visits and a 4% increase in emergency room visits year over year.”
  • Beckers Hospital Review points out,
    • “Boston-based New England Baptist Hospital has the lowest hospital wide readmission rate, while Oroville (Calif.) Hospital has the highest, according to CMS’ Unplanned Hospital Visits database.
    • “The data, released Aug. 6, is based on provider data for hospital return days, including unplanned readmission measures and measures of unplanned hospital visits after outpatient procedures. The data was collected between July 1, 2023, and June 30, 2024.
    • “The article identifies] the 10 hospitals with the highest and lowest hospital wide readmission rates, along with their respective scores.
  • Medical Economics relates,
    • “For decades, referrals and word-of-mouth were the main routes to finding a new physician. Now, according to rater8’s 2025 report, “The Next Evolution of Patient Choice: The Rise of AI in Healthcare Search,” patients are increasingly relying on artificial intelligence (AI), online reviews and social media when deciding where they should seek care.
    • “The survey of more than 1,000 U.S. adults found that 70% are open to — or are already using — AI tools to research physicians. Among patients, 26% said AI recommendations directly influenced their decision — nearly equal to primary care referrals (28%) and health care review sites (29%).”
  • MedTech Dive calls attention to the fact that the “robotic surgery market battle is heating up. After a busy summer of surgical robotics news, check out MedTech Dive’s roundup of coverage in the space.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NCQA, NIH, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The OPM Inspector General recently issued a data brief titled Evaluation of FEHBP Medical Conditions by Premium Expenditure during Contract Years 2019 through 2021. The most expense conditions, representing 10% of spending, was cancer.
  • STAT News reports,
    • “The Centers for Disease Control and Prevention is increasing security after the shooting at its Atlanta headquarters earlier this month, leaders told employees in an email reviewed by STAT.
    • “Additional guards have been added to nearly all campuses, according to the email. CDC is in talks with the Federal Protective Services to increase security at two the campuses where it provides security as well, per the email.”
  • and
    • “Sens. Roger Marshall (R-Kansas) and John Hickenlooper (D-Colo.) are leading a new push to strengthen requirements on price transparency in hospitals, Marshall writes in a new STAT First Opinion article.
    • “The two senators introduced a new bill, the Patients Deserve Price Tags Act, which would require machine-readable files for all negotiated and cash prices, require hospitals to post prices for services, and require patients to receive an explanation of benefits as well as an itemized bill.
    • “It’s part of a years-long movement to crack down on billing practices among providers — one the White House joined in earlier this year via executive order.
    • “But the bipartisan push is far from a guarantee of changes in the current law. Even some widely backed health proposals in Congress have been left behind in must-pass packages. Read Marshall’s piece.”
  • Per a CMS news release,
    • “The U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) are establishing the Healthcare Advisory Committee—a group of experts charged with delivering strategic recommendations directly to HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz to improve how care is financed and delivered across Medicare, Medicaid and the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.
    • “Every American high-quality, affordable care – without red tape, corporate greed, or excessive costs,” said HHS Secretary Robert F. Kennedy Jr. “This new advisory committee will unite the best minds in healthcare to help us deliver real results, hold the system accountable, and drive forward our mission to Make America Healthy Again.” * * *
    • “For more information or to submit nominations, visit the Federal Register Notice at: https://www.federalregister.gov/d/2025-16136.” 
  • Healthcare Dive observes,
    • “White House data sharing plan boasts big ambitions, but has scant details.
    • “Improving health data exchange is a worthy goal, but the initiative has to overcome challenges like data security, under-resourced providers and slow technology uptake, experts say.”
  • Per BioPharma Dive,
    • “The United States and the European Union formalized the terms of the framework trade agreement the two trading partners announced at the end of July, per a joint statement published by the White House Thursday.
    • “The statement provides additional clarity and detail surrounding the terms U.S. President Donald Trump and European Commission President Ursula von der Leyen shared following negotiations in Scotland on July 27, including a 15% tariff on EU imports by the U.S. The two trading partners will “promptly document” the agreement, per the statement.
    • “Under the agreement, the U.S. committed to apply either a tariff of 15% or a “most-favored nation” duty rate on EU imports, with the higher of the two to be enforced. The U.S. will set a cap of 15% on tariffs for imports of pharmaceuticals, semiconductors and lumber, per the statement. Those sectors are currently under Section 232 investigation. Similar probes have led to sector-specific tariffs of up to 50%.
    • “The U.S. also plans to apply only the most-favored nation rate set by the World Trade Organization to aircraft and aircraft parts, generic pharmaceuticals, chemical precursors and “unavailable natural resources,” effective Sept. 1. The two trading partners will “consider other sectors” to add to that group.”
  • The Government Accountability Office tells us,
    • “Over the last decade, federal revenues from tobacco excise taxes have dropped by more than 30%—from about $14 billion to $9 billion from fiscal years 2014 to 2024.   
    • “This loss in revenues is the result of 1) declines in sales for smoking products and 2) differing tax rates for these products. It also coincides with the emergence of new products that aren’t taxed at all.” * * *
    • “If similar tobacco products were taxed the same rate (keeping in mind that some aren’t taxed at all), federal revenues would increase. We estimated that if the tax rate for pipe tobacco were increased to the same rate as roll-your-own tobacco, the federal government could collect at least $1.5 billion dollars in additional revenue for both products from fiscal years 2025-2029.  
    • “Federal revenue would also likely increase if the minimum tax rate for large cigars was the same as that for small cigars. However, it’s a bit trickier to determine a precise estimate because of limited information about the retail prices of large cigars and how consumers might respond to increased taxes.  
    • “We previously recommended that Congress consider leveling (or equalizing) the tax rate on similar tobacco products.  For a more in-depth look at tobacco taxes, check out our new report.” 
  • Tammy Flanagan, writing in Govexec, points out that “Federal employees older than 70 may be leaving thousands on the table. Find out if you or your spouse is missing Social Security benefits.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds.
    • “Plant, once owned by Catalent and now owned by Novo Nordisk, is widely used by pharma industry.
  • and
    • “The Food and Drug Administration has agreed to decide by late next month whether to approve an ultra-rare disease drug developed by Stealth BioTherapeutics, a significant step after the company claimed it may have to close its doors if an agency endorsement is not made in coming weeks.
    • “The move comes after protracted uncertainty surrounding the fate of the medication, which was developed to treat Barth syndrome, a rare illness that afflicts about 150 people in the U.S. The company and the FDA have struggled to agree on ways to generate enough of the right kind of study data to make the drug available to this tiny population of patients.”
  • PharmaPhorum lets us know,
    • “Iterum Therapeutics has become the first drugmaker to bring an oral antibiotic in the penem class to market in the US, launching Orlynvah as a treatment for uncomplicated urinary tract infections (uUTIs).
    • The launch of the product – which comes a few months after Orlynvah (sulopenem etzadroxil and probenecid) was approved by the FDA – keeps the Dublin, Ireland-headquartered biotech ahead of rival companies bidding to bring new therapies for uUTIs to the US market.
    • That includes GSK with Blujepa (gepotidacin) – which was approved in March by the FDA as the first drug with a new mechanism of action for uUTIs in nearly three decades – as well as Alembic Pharma with Pivya (pivmecillinam), cleared for uUTIs in 2024 and acquired when Alembic bought Utility Therapeutics last month. Both Blujepa and Pivya are due to be launched in the US before the end of the year.
    • Specifically, Orlynvah was given a green light by the FDA for adult women with uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis with limited or no alternative oral antibacterial options. It was initially turned down by the agency, which issued a complete response letter (CRL) to Iterum in 2021 with a request for more data.
  • Per MedTech Dive,
    • “NeuroOne Medical Technologies received Food and Drug Administration clearance for a minimally invasive nerve ablation system to treat trigeminal neuralgia, a condition that causes severe, chronic facial pain.
    • “Trigeminal neuralgia is typically treated with medication or invasive procedures. NeuroOne’s OneRF ablation system uses radiofrequency energy to create lesions to interrupt pain signals.
    • “NeuroOne filed its FDA submission in April, earlier than previously anticipated. The Eden Prairie, Minnesota-based company said Monday it now expects to launch the device on a limited basis in the fourth quarter of this year.”
  • BioPharma Dive informs us,
    • “The Food and Drug Administration on Thursday approved a drug Ionis Pharmaceuticals developed for the rare genetic disease hereditary angioedema, making the therapy, known as donidalorsen, the third new medicine to reach market this year for the rare genetic condition.
    • “Donidalorsen, which Ionis will sell under the brand name Dawnzera, is approved to prevent the swelling attacks associated with hereditary angioedema in adults and children at least 12 years of age. Dawnzera has a list price of $57,642 per dose, company executives said in a conference call.
    • “The price is “based on the efficacy, the data and the supporting evidence,” Chief Global Product Strategy Officer Kyle Jenne told analysts on the call. “The payers, we believe, will be very accepting of the price, since it’s in line with the other products that are in the HAE space today.”
  • and
    • “A total of 1,176 products have received the Food and Drug Administration’s breakthrough device designation since 2015, according to the agency’s latest update on Wednesday.
    • “The FDA gives the designation to devices that may provide more effective treatment or diagnosis of life-threatening or debilitating conditions. In its 2025 fiscal year, which began in October, the agency had granted 136 breakthrough designations as of June 30.
    • “The FDA shared the update as medical device companies lobby for faster Medicare coverage of breakthrough devices.”

From the judicial front,

  • Bloomberg Law reports,
    • “A divided US Supreme Court let the Trump administration cut off potentially hundreds of millions of dollars in medical research grants that government officials say don’t align with the president’s policies.
    • “The justices largely put on hold a federal trial judge’s decision that the National Institutes of Health acted in an “arbitrary and capricious” manner when it terminated thousands of grants as part of President Donald Trump’s crackdown on diversity, equity and inclusion.”

From the public health and medical research front,

  • Per an FDA news release,
    • “FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Frozen, Raw, Half-shell Oysters from Republic of Korea Potentially Contaminated with Norovirus.”
  • Health Day informs us,
    • “Seniors with known heart-related problems aren’t doing a very good job taking steps to protect their health, a new study says.
    • “Older folks with high blood pressure, stroke survivors and heart failure patients in the United States all have been neglecting Life’s Essential 8 — a checklist of lifestyle factors that can protect heart health, researchers found.
    • “On average, participants with one cardiovascular disease had a Life’s Essential 8 score 9 points lower than those without cardiovascular disease,” lead researcher James Walker, a medical student at Northwestern University in Chicago, said in a news release.
    • “Life’s Essential 8 recommends that people eat healthy, exercise, avoid smoking, sleep better, lose excess weight, and manage their cholesterol, blood sugar and blood pressure levels, according to the American Heart Association.”
  • MedPage Today lets us know,
    • “Patients taking GLP-1 agonists for weight loss had a small but significantly lower risk of developing cancer, a large retrospective cohort study showed.
    • “With follow-up ranging from 1 to 11 years, use of GLP-1 agonists, such as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), was associated with a 17% lower cancer risk as compared with non-users. Cancer incidence was lower for 12 of 13 recognized obesity-related cancers, plus lung cancer. The difference between users and non-users reached statistical significance for endometrial and ovarian cancers and meningioma.
    • “The only outlier was kidney cancer, which occurred more often among users of GLP-1 agonists and was associated with a non-significant 38% increased risk, reported Jiang Bian, PhD, of the Regenstrief Institute in Indianapolis, and co-authors in JAMA Oncology.
    • “Given that more than 137 million individuals in the U.S. are currently eligible for GLP-1RA [receptor agonist] therapies, even modest changes in cancer risk could have substantial public health implications,” the authors stated in their discussion. “This study is one of the first to assess the association between GLP-1RA use and cancer risk in the broad, real-world population with obesity or overweight who are eligible for AOMs [anti-obesity medications].”
  • Per a National Institute of Standards and Technology news release,
    • “Scientists at the National Institute of Standards and Technology (NIST) have developed a new technology for measuring how radiation damages DNA molecules. This novel technique, which passes DNA through tiny openings called nanopores, detects radiation damage much faster and more accurately than existing methods. It could lead to improved radiation therapy for cancer and more personalized care for individuals during radiological emergencies.
    • “With nanopore sensing, we’re not just measuring radiation damage; we’re rewriting the rules on how quickly and effectively we can respond to both cancer care and emergencies,” said NIST physical scientist Joseph Robertson.”
  • Per a National Institutes of Health news release,
    • “In a first-of-its-kind study, researchers found that the brain’s control center for a lost appendage can persist long after surgical amputation, which stands in stark contrast to longstanding theories about the brain’s ability to reorganize itself, also known as plasticity. Scientists from the National Institutes of Health (NIH) and their colleagues examined human brain activity before and after arm amputation and found that the loss of a limb does not prompt a large-scale cerebral overhaul. Published in the journal Nature Neuroscience, this study offers new insight into the mysterious phantom limb syndrome and could help guide the development of neuroprosthetics and pain treatments for people with limb loss.
    • “A team of scientists from NIH and University College London acted on a unique window of opportunity, running MRI scans on three participants in the months prior to a planned amputation (performed for separate medical purposes) and then up to five years after.
    • “It’s not often you get the chance to conduct a study like this one, so we wanted to be exceedingly thorough,” said co-author Chris Baker, Ph.D., of NIH’s National Institute of Mental Health (NIMH). “We approached our data from a variety of angles and all of our results tell a consistent story.”
  • Per NCQA.
    • ‘Chronic kidney disease (CKD) affects nearly 36 million adults in the U.S., yet it remains underdiagnosed and undertreated. NCQA convened an expert panel of clinicians and patient advocates to discuss current challenges and future opportunities associated with the assessment, diagnosis and management of CKD.’
    • This NCQA article discusses this convention.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth is forming a new board committee to “monitor and oversee financial, regulatory and reputational risks” as the healthcare juggernaut tries to improve its standing with lawmakers, regulators, investors and the U.S. public.
    • “The “public responsibility committee” will “provide an additional layer of governance,” UnitedHealth said in a securities filing on Wednesday. The committee’s key responsibilities include underwriting and forecasting, regulatory relationships, reputational matters and mergers and acquisitions — all areas for which UnitedHealth has been in the public eye.
    • “Michele Hooper, who’s served on UnitedHealth’s board since 2007, will step down as lead independent director to chair the committee. Hooper, who will remain a director, will be replaced as lead independent director by F. William McNabb, the former CEO of investing firm the Vanguard Group who has served on UnitedHealth’s board since 2018.”
  • The International Foundation of Employee Benefit Plans discusses various GLP-1 coverage strategies.
  • Per Beckers Hospital Review,
    • “Philadelphia-based Temple Health has acquired Redeemer Health’s 20% stake in Chestnut Hill Hospital, giving the academic system an 80% ownership interest in the hospital.
    • “This was a planned transaction that comes approximately two and a half years after Chestnut Hill Hospital was acquired by an alliance consisting of Temple Health, [Meadowbrook, Pa.-based] Redeemer and the Philadelphia College of Osteopathic Medicine,” a spokesperson for the health system told Becker’s. “Temple Health manages Chestnut Hill Hospital and now has an 80% ownership stake in the hospital.”
    • “With the transaction, Redeemer has exited the alliance, while the Philadelphia College of Osteopathic Medicine retains a 20% ownership stake in the148-bed hospital.”
  • and
    • “Sacramento-based Sutter Health plans to close its Jackson, Calif.-based Sutter Amador Surgery Center on Oct. 3.
    • “In an open letter to the community, obtained by Becker’s, Sutter Amador Hospital CEO Michael Cureton, Sutter Amador Surgery Center’s ambulatory services administrator, Branden Nelson, and the surgery center’s executive of operations, Johnny Russell, said the outpatient surgery center closure will help “align resources with areas of growing need” in the community it serves.”
  • Radiology Business relates,
    • “A “hybrid” artificial intelligence strategy—using a combination of radiologist readers and standalone AI interpretation of cases—can cut rads’ workloads by nearly 40%, according to new research. 
    • “Such technology has shown great promise in boosting physician performance, including helping to triage scans requiring added attention. However, AI implementation in breast cancer screening remains limited for various reasons, amid concerns it may miss some relevant cases, experts wrote Tuesday in RSNA’s Radiology.” 
  • BioPharma Dive reports,
    • Gilead Sciences is deepening its investment in cancer cell therapy, announcing Thursday a deal to pay $350 million to buy privately held Interius BioTherapeutics for a technology designed to reprogram immune cells in patients’ bodies.
    • If successful, Interius’ “in vivo” approach could yield a simpler alternative to the CAR-T therapies Gilead’s Kite Pharma division have brought to market, each of which includes extravagant production processes that involve manipulating cells in a lab. 
    • Gilead spent $12 billion to buy Kite nearly a decade ago and, since then, has become a leader in CAR-T therapies. That business has sputtered recently amid declining demand and competition from other developers. But Gilead is still investing through acquisitions and partnerships, such as a collaboration with Arcellx in multiple myeloma.
  • and
    • “Sarepta on Thursday said it’s reached agreements that remove about $700 million from a pile of debt due in 2027.
    • “The private agreements with debt holders will allow Sarepta to exchange the 1.25% convertible senior notes due in 2027 for $602 million worth of 4.875% convertible senior notes due in 2030, up to 6.7 million shares of Sarepta stock and about $123 million in cash. Separately, the company entered into a private placement of about 1.4 million shares.
    • “The transaction “significantly enhances our balance sheet flexibility and strengthens our financial position,” Sarepta CEO Doug Ingram said in a statement. Sarepta will still have $450 million in existing convertible notes due in 2027.”
  • and
    • “Xoma Royalty Corp. is acquiring another struggling biotechnology company in further sign of interest among certain firms in buying floundering drugmakers and shutting them down.
    • “Xoma on Wednesday agreed to buy Mural Oncology, a cancer biotech once spun out of Alkermes. Per deal terms, a Xoma subsidiary will acquire Mural for $2.035 per share. Mural stockholders could get up to another $0.205 per share if the company’s net cash holdings at the deal’s closing exceeds $36.2 million.
    • “The deal values Mural at the level of its cash reserves and represents a roughly 13% premium to the company’s closing share price of $1.80 on Tuesday. Xoma will wind down Mural’s business afterwards, according to the announcement.
    • “In acquiring and liquidating Mural, Xoma is extending a pattern among certain firms and investors to shut down drug companies whose depressed share prices leave them worth less than their cash holdings. Historically, these biotech “zombies” would pivot to new projects or merge with another drug company. Of late, however, investors are heightening pressure on company boards to return cash to shareholders instead.”

Midweek report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Bloomberg Law notes,
    • Gender-affirming care will no longer be covered for federal workers in 2026, according to a letter the Trump administration sent to insurance carriers. * * *
    • The announcement, dated Aug. 15, cements the administration’s expected move to halt gender-affirming care following President Donald Trump’s January executive order to enforce laws based on a person’s biological sex. The exclusion likely tees up legal challenges under Title VII of the 1964 Civil Rights Act and Section 1557 of the Affordable Care Act, both of which contain anti-discrimination protections.
    • “This discriminatory policy denying medical care to government employees and their dependents is not only cruel—it is illegal,” Omar Gonzalez-Pagan, Lambda Legal counsel and health-care strategist, said in a statement. “The federal government cannot simply strip away essential healthcare coverage from transgender employees while providing comprehensive medical care to all other federal workers.”
  • The American Hospital Association News points out,
    • “A JAMA study published Aug. 18 found that plan design changes by Medicare Part D insurers, particularly for Medicare Advantage plans, following passage of the Inflation Reduction Act of 2022 could lead to higher cost sharing for some beneficiaries who do not reach the $2,000 out-of-pocket maximum for prescription drug coverage in 2025. Researchers said policies prevented premium increases in 2025, but Part D plans may have responded by increasing deductibles or medication cost sharing. The study found mean deductibles for MA plans decreased from $153 in 2019 to $66 in 2024, before sharply increasing to $228 for 2025. Additionally, the proportion of MA beneficiaries with coinsurance for preferred brand-name drugs ranged from 0.8% to 2.5% from 2019 to 2024, before increasing to 27.7% in 2025.”
  • BioPharma Dive tells us,
    • “A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this month. But nestled within leaked documents is a strategy that reveals more about health leaders’ goals, including potential new oversight of pharma’s direct-to-consumer advertising practices.
    • “DTC advertising has long been a target of Health and Human Services Secretary and MAHA leader Robert F. Kennedy Jr. While Congress has taken some interest in passing a ban on those ads, real reform hasn’t gained momentum.” * * *
    • “Listed under “policy reforms” within the draft, the focus on DTC advertising states that the FDA, HHS, the Federal Trade Commission and Department of Justice would “increase oversight and enforcement” under current laws for DTC prescription drug advertising violations. Instead of focusing on all media platforms, the agencies will “prioritize the most egregious violations,” such as those by social media influencers and telehealth companies.”
  • AP reports,
    • “When the Food and Drug Administration needs outside guidance, it normally turns to a trusted source: a large roster of expert advisers who are carefully vetted for their independence, credentials and judgment.
    • “But increasingly, the agency isn’t calling them.
    • “Instead, FDA Commissioner Marty Makary has launched a series of ad hoc “expert panels” to discuss antidepressants, menopause drugs and other topics with physicians and researchers who often have contrarian views and financial interests in the subjects.”

From the judicial front,

  • Beckers Payer Issues informs us,
    • “A federal judge has approved a $2.8 billion settlement resolving antitrust claims brought by healthcare providers against the Blue Cross Blue Shield Association and its independent entities, ending more than a decade of litigation.
    • “The settlement was approved Aug. 19 and covers a class of millions of hospitals, physician practices, and other providers nationwide who accused the Blues of conspiring to divide up markets to avoid competing with one another, which allegedly drove up costs and reduced reimbursements.
    • “Under the agreement, about $1.78 billion will be distributed to healthcare facilities, while $152 million is earmarked for medical professionals. The settlement also implements structural reforms valued at more than $17 billion, including how BCBS plans process claims, and how they communicate, contract with, and make payments to providers. The settlement applies to providers who treated BCBS members between July 2008 and October 2024.”
  • Per Healthcare Dive,
    • “A federal judge has vacated a Biden-era rule that would have curbed Medicare Advantage plans’ payouts to agents and brokers.
    • “On Monday, Judge Reed O’Connor of the Texas Northern District Court ruled that the CMS overstepped its authority in trying to cap payments to MA sales organizations beyond direct compensation, and in prohibiting contracts that incentivize brokers to steer seniors to specific plans.
    • “CMS may only regulate how compensation is used, not engage in ratemaking,” O’Connor wrote in his decision. It’s a loss for smaller plans, which argue that the status quo benefits larger and wealthier insurers, and a setback for efforts to curb predatory marketing in the privatized Medicare program.”
  • and
    • “Elevance has lost a legal bid to improve its Medicare Advantage quality ratings for 2025.
    • “On Monday, a Texas federal judge threw out the insurer’s suit and offered a biting indictment of Elevance’s legal argument, saying it relied on distorted math.
    • “The lower star ratings will cost Elevance at least $375 million in bonus payments and rebates.”
  • Per a U.S. Justice Department news release,
    • “Troy Health, Inc. (Troy), a North Carolina-based provider of Medicare Advantage, Medicare Part D, and Dual Eligible Special Needs Plans, has entered into a non-prosecution agreement with the Department of Justice to resolve a criminal investigation into a health care fraud and identity theft scheme involving the use of artificial intelligence and automation software to illegally obtain Medicare beneficiary information and fraudulently enroll beneficiaries into its Medicare Advantage plans.
    • “Troy told low-income Medicare beneficiaries that it would use new technologies, including its proprietary artificial intelligence platform, to improve patient health outcomes,” said Acting Assistant Attorney General Matthew Galeotti of the Justice Department’s Criminal Division. “Instead, the company misused patient data to enroll beneficiaries in its Medicare Advantage plan without their consent. Today’s resolution reflects the Criminal Division’s emerging focus on corporate enforcement in the health care space and holding both individuals and companies accountable when they defraud our medical system to enrich themselves at the expense of the American taxpayer.”
  • Per a news release from the U.S. Attorney for the Northern District of California,
    • “American Psychiatric Centers, Inc., doing business under the name Comprehensive Psychiatric Services (CPS), has agreed to pay $2.75 million to resolve allegations that CPS violated the False Claims Act by submitting false claims to government healthcare payors for certain psychotherapy services.
    • “CPS, which is headquartered in Walnut Creek, Calif., provides behavioral medicine services for individuals and families in the State of California.  Since at least 2015, CPS and its healthcare providers have submitted claims to government payors using Current Procedural Terminology codes 90833 and 90836, which are “add-on” codes to be used when psychotherapy services are performed in conjunction with an evaluation and management visit, and which require specific documentation.
    • “The settlement announced today resolves the government’s allegations that, from Jan. 1, 2015, through Dec. 31, 2022, CPS submitted fraudulent claims using these add-on codes in instances where its healthcare providers either had not provided the services described by those codes or had failed to sufficiently document that such services had been provided.  CPS will pay $2,615,569.32 to the United States and $134,430.68 to the State of California. * * *
    • “False claims increase costs and undermine the integrity of our federal health care programs, including the Federal Employees Health Benefits Program,” said Derek M. Holt, Special Agent in Charge, the U.S. Office of Personnel Management Office of the Inspector General (OPM OIG). “We support the work of our law enforcement partners and colleagues to investigate fraudulent medical billing that wastes taxpayer dollars.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 19, 2025, a total of 1,375 confirmed measles cases were reported by 42 jurisdictions: Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York City, New York State, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.
    • “There have been 35 outbreaks reported in 2025, and 87% of confirmed cases (1,190 of 1,375) are outbreak-associated. For comparison, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.”
  • Per Medscape,
    • “The experimental drug obicetrapib, a potent oral cholesteryl ester transfer protein (CETP) inhibitor, significantly slowed Alzheimer’s disease (AD) biomarker progression over 12 months in patients with cardiovascular disease, new research showed.
    • “Results revealed the drug led to a 20% improvement in levels of phosphorylated tau 217 (p-tau217) — an important indicator of AD pathology — in patients carrying the apolipoprotein E (APOE4) allele. About 65% of people with AD are APOE4 carriers.
    • “The treatment was already shown to reduce LDL cholesterol and increase HDL cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
    • “It’s encouraging to have a drug that treats cardiovascular disease and treats or prevents AD, study investigator Philip Scheltens, MD, PhD, professor of neurology and founder of the Alzheimer’s Center, Amsterdam University Medical Center, Amsterdam, the Netherlands, told Medscape Medical News.“
  • Per the University of Minnesota’s CIDRAP,
    • “Non-White US Lyme disease patients with Medicaid or Medicare coverage were more likely than their White peers to be female, hospitalized at diagnosis, diagnosed outside of primary care and the summer months, and to have disseminated disease (more widespread in the body), per a new study by Pfizer scientists co-developing a vaccine against the tick-borne infection with Valneva.
    • “From 2016 to 2021, the researchers analyzed claims-based data from 15 Lyme-prevalent states and Washington, DC, on Medicaid beneficiaries 18 years and younger and 19 and older and Medicare fee-for-service beneficiaries younger than 65 and 65 and older. 
    • “The findings were published Monday in Emerging Infectious Diseases.”
  • Medscape also calls attention to five things to know about cervical cancer.
  • Per the AHA News,
    • “B. Braun Medical has voluntarily recalled two lots of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL IV fluids due to particles inside the container, according to the Food and Drug Administration. The company said there have been no reports of serious injury, death or other adverse events associated with the issue. B. Braun said affected products should be returned to the company and not be destroyed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance companies are looking to cut costs by ranking providers like they tier pharmaceuticals.
    • “Last week, HealthPartners announced plans to offer large employers its Simplica NextGen Copay, a plan that sets fixed copays by provider and eliminates coinsurance and deductibles. CVS Health subsidiary Aetna is rolling out Aetna Informed Choice, a new plan for employers based on its variable copay plan, a spokesperson said in an email. In February, Blue Cross and Blue Shield of Minnesota launched a new investment arm focused on developing tools for its variable copay plan, Coupe Health.
    • “There’s been a resurgence in them,” said Katherine Hempstead, senior policy officer at the Robert Wood Johnson Foundation, a healthcare research philanthropy. 
    • “Variable copay plans are part of the tide of alternative health plans that have emerged in recent years, promising to help employers save costs without shifting more of the expenses to employees by raising deductibles. Like high-deductible plans, variable copay plans operate on the assumption that giving consumers “skin in the game” will drive them to select the most cost-effective service. High-deductible plans often raise costs for patients and insurers because high upfront costs drive patients to forego preventive care or drugs needed to manage their condition, worsening their health, according to a 2018 study by the University of Southern California Leonard D. Schaeffer Center Institute for Public Policy and Government Service. 
    • “The variable copay plans are constructed similarly to a tiered provider network, a long-standing health insurance benefits design that gives members the option of seeing the full array of providers but lowers cost-sharing if enrollees choose the preferred clinicians. 
    • “These are not new and not shiny,” said Sabrina Corlette, co-director of the Georgetown University Center on Health Insurance Reforms.”
  • Per Beckers Hospital Review,
    • Rochester, Minn.-based Mayo Clinic recorded an income from current activities of $380 million (7.1% margin) in the second quarter of 2025 quarter, down from $449 million (8.9% margin) during the same period last year, according to its Aug. 18 financial report. 
    • Total operating revenue was $5.3 billion for the three months ended June 30, up from $5 billion during the same period last year. Mayo’s net patient service revenue was $4.5 billion, an 8.6% increase year over year. The system attributed the growth to strong outpatient, surgical and hospital volumes, as well as increased service demand. 
  • and
    • “Somerville, Mass.-based Mass General Brigham recorded an operating income of $74.4 million (1.3% operating margin) in the third quarter of 2025, up from $47.2 million (0.9% margin) during the same period last year, according to its Aug. 15 financial report. 
    • “The system reported total operating revenue of $5.8 billion for the three months ended June 30, a 12% increase year over year. Patient care revenue totaled $3.7 billion, an 8% increase year over year. The system said this reflected a 3% increase in acute care discharges. Premium revenue increased 19% year over year to $671 million.”
  • Modern Healthcare adds,
    • Hospital costs are growing as an increasing number of sicker patients visit the emergency department, according to a new report.
    • “The average cost of an inpatient stay rose 4.8% from mid-2023 to early 2025, according to the latest national data from Sg2, a data analytics company owned by group purchasing organization Vizient. At academic medical centers, per-case cost growth nearly doubled the rate of expense inflation at community hospitals between the first quarters of 2022 and 2025.
    • “Most people arriving at emergency departments require immediate attention, which may help explain why treatment costs are increasing. Hospitals are having a tough time keeping up with demand for care as the population ages, leading to overcrowded ERs and full inpatient units. 
    • “Providers are expected to get even busier over the next 10 years, potentially creating more care backlogs, according to the report.” 
  • Beckers Hospital Review also shares RN median hourly rates by state.
    • “Median hourly base pay for registered nurses varies across states, with RNs in California earning the most, according to SullivanCotter’s “2025 Health Care Staff Compensation Survey Report.”
    • “The survey, released in July, covers nearly 2.5 million healthcare employees across over 2,660 participating organizations, including more than 800,000 individual RNs, licensed practical nurses and nursing managers.”
  • MedTech Dive offers an interview with Josep Solà, the CEO of Aktiia, whose company received In July, FDA authoriz[ation for] the first over-the-counter cuffless blood pressure monitor.
  • and tells us
    • “Venture capital investment in medtech surged at the start of 2025, prompting PitchBook to forecast a strong year ahead for funding in the sector after several sluggish years.
    • “The market data research firm counted 11 rounds worth at least $100 million each, and $4.1 billion in total venture capital funding in the first quarter alone. Brain implant startup Neuralink’s $650 million Series E financing, announced in June, was a standout as momentum continued in the second quarter.
    • “In a steady stream of private financings this summer, heart devices have been a focus. In July, Kardium announced it raised $250 million as it prepares to launch its pulsed field ablation system for atrial fibrillation, and Field Medical brought in another $35 million to study PFA in ventricular tachycardia.”
  • Beckers Hospital Review relates,
    • “Walgreens Specialty Pharmacy, which earned $25.9 billion last year from U.S. prescription revenue, has expanded its limited distribution drug portfolio to 265 medications, the company said Aug. 19. 
    • “Limited distribution drugs are specialty medications that have complex regimens, high costs and/or special handling requirements. Therapies for chronic diseases and cancers are typically administered at specialty pharmacies. These medications account for about 75% of drugs in development, according to Walgreens. 
    • “The company’s specialty pharmacy added leukemia drug Imkeldi (imatinib), HIV preventive Yeztugo (lenacapavir) and chronic skin condition treatment Imkeldi (imatinib) to its network.” 

Tuesday Report

David Ermer–Uncategorized–

From Washington, DC,

  • OPM’s second addendum to its call letter for 2026 benefit and rate proposals now appears on OPM’s website.
  • The reginfo.gov website now features the following advisory:
    • “Reginfo.gov is currently undergoing revisions. Until this temporary issue is resolved, data related to EO 12866 reviews and information collection requests (ICRs) may not accurately update. EO 12866 meeting requests and public comments submitted for ICRs will be handled via email until this issue is resolved.
    • “To request an EO 12866 meeting, please send an email to MBX.OMB.OIRA.EO12866Requests@omb.eop.gov
      • For EO 12866 Meeting Requests, please use the following subject line: “EO 12866 Meeting Request: [RIN] [Rule Title].” The Regulatory Identification Number (RIN) can be found on reginfo.gov. Please list the requestor’s name and affiliation, as well as anticipated attendees in the body of the email request.
    • “To submit a comment on an information collection request, please email your comment to MBX.OMB.OIRA.ICRComments@omb.eop.gov with the subject line: “ICR Comment: [OMB Control Number] [Collection Title].”
  • That’s right; the advisory does not mention the premature semi-annual regulatory update which triggered several days of a blank screen with an “under maintenance” notice.
  • Federal News Network tells us,
    • “Federal employees traveling for business will not see an increase in the rates the government will pay for hotels, meals and incidentals in fiscal 2026. The General Services Administration said the per diem rates for the continental United States will stay the same for next fiscal year. GSA said the decision not to increase the rates reflects the government’s commitment to being a responsible steward of taxpayer dollars, ensuring that federal funds are utilized appropriately, cost-effectively and for core mission-related activities. The standard rate applies to most of CONUS, which for lodging is $110. There are 296 non-standard areas with individual rates that are higher than the standard rate. The meals and incidental rates range from $59 to $92.(Per diem rates for 2026 will not increase – General Services Administration)”
    • The GSA rates also apply to experience rated FEHB and PSHB carrier employee travel expenses.
  • The Beers Hamerman account firm reminds us,
    • A significant shift is underway in how the federal government will deliver some tax refunds and benefit payments. Starting September 30, 2025, paper checks from the IRS, Social Security Administration (SSA) and other federal agencies will become a thing of the past. The move toward a fully electronic system aims to cut costs, minimize fraud and streamline payment delivery — but it will require action from some taxpayers.
    • The shift applies OPM’s retirement program (CSRS and FERS) benefits payment system.
    • Most taxpayers will benefit from faster, safer payments. However, not every scenario fits neatly into this digital transformation. Here are examples of taxpayers that may experience challenges:
      • “Taxpayers abroad. U.S. citizens living overseas may not have access to U.S.-based banks. Because the IRS doesn’t support direct deposit to most foreign accounts, expatriates may face unique challenges. The federal government is expected to address this issue in future guidance, possibly by offering alternative methods.
      • “Estates and trusts. Executors handling final tax returns for deceased individuals may face complications. For example, a tax refund must be deposited into an account matching the taxpayer’s name — an issue when dealing with estate accounts. The American Institute of Certified Public Accountants has asked the U.S. Treasury Department to issue updated procedures and offer flexibility in these cases.
      • “Privacy concerns. Some taxpayers are uncomfortable sharing their banking information with the IRS. While electronic payments are safer overall, public concerns about data privacy remain a barrier for some.”
  • Federal News Network summarizes OPM’s latest guidance about leave, awards, and more for federal employees.
    • “In the last few weeks alone, OPM has offered answers to questions about the Trump administration’s changes to the federal probationary period, as well as updates on the use of paid administrative leave.
    • “On top of that, there are some changing expectations in how the administration wants agencies to manage employee reviews, and how top performers should be awarded for their work.”

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “FDA is actively investigating reports of Cesium-137 (Cs-137) contamination in shipping containers and frozen shrimp products processed by PT. Bahari Makmur Sejati (doing business as BMS Foods) of Indonesia. The U.S. Customs & Border Protection (CBP) alerted FDA to the detection of Cs-137 in shipping containers at four U.S. ports (Los Angeles, Houston, Savannah, and Miami). FDA collected multiple samples for radionuclide analysis, with results confirming the presence of Cs-137 in one sample of breaded shrimp. All containers and product testing positive or alerting for Cs-137 have been denied entry into the country. The agency continues to coordinate with CBP to prevent any contaminated products from reaching consumers and is working with Indonesian seafood regulatory authorities to investigate the root cause of the contamination. 
    • “Although testing to date has not confirmed the presence of contamination in any product in commerce, the product appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with Cs-137 and may pose a safety concern. To date, FDA has learned that Walmart has received implicated raw frozen shrimp, imported after the date of first detection of Cs-137 by CBP, but from shipments that did not alert for Cs-137. FDA has recommended Walmart recall this product. 
    • “Consumers should not eat or serve certain lots of Great Value raw frozen shrimp sold at Walmart stores in AL, AR, FL, GA, KY, LA, MO, MS, OH, OK, PA, TX, and WV:  
      • Great Value brand frozen raw shrimp, lot code: 8005540-1, Best by Date: 3/15/2027 
      • Great Value brand frozen raw shrimp, lot code: 8005538-1, Best by Date: 3/15/2027 
      • Great Value brand frozen raw shrimp, lot code: 8005539-1, Best by Date: 3/15/2027. 
    • If you have recently purchased raw frozen shrimp from Walmart that matches this description, throw it away. Do not eat or serve this product.
  • and
    • “The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling 246.5 Lbs. of 100% Grass-fed Pepper Jack Cheese, sold in 8 oz. packages, 5 lb. loaves and 40 lb. loaves, 2.5 Lbs. of Horseradish Flavored Cheese, sold in 8 oz. packages, 640 Lbs. of Monterey Jack Cheese sold in 8 oz. packages, 5 lb. loaves and 40 lb. loaves, and 4,544.5 Lbs. of White Cheddar Cheese sold in 40 Lb. loaves because of potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
    • “The recalled products were produced on June 16, 2025, June 24, 2025, and July 16th, and distributed in the state of Ohio between July 14, 2025, and August 7, 2025. Products were shipped to manufacturers and distributors and sold in retail stores.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today issued a declaration that allows the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations (EUAs) for animal drugs to treat or prevent infestations caused by the New World Screwworm (NWS). This declaration applies only to drugs for animals.
    • “NWS infests warm-blooded animals, including livestock, pets, wildlife, and, in rare cases, humans, causing severe tissue damage and sometimes death. The risk to human health in the United States remains very low, but the potential future threat to animal populations and the food supply chain requires proactive action. Although eradicated from North America and Central America decades ago, NWS has progressed north since 2022 and is now approaching the U.S. border with Mexico. This parasite poses an emerging threat to livestock and food security, with potential impacts on both national security and animal health.
    • “Today we are taking decisive action to safeguard the nation’s food supply from this emerging threat,” said HHS Secretary Robert F. Kennedy, Jr. “This authorization equips FDA to act quickly, limit the spread of New World Screwworm, and protect America’s livestock.”
  • Per MedTech Dive,
    • “Medtronic has recalled cardiac catheters because of a problem cited in three reports of serious injuries.
    • “The Food and Drug Administration published an early alert about the removal of the products Friday, after Medtronic sent a letter to customers on Aug. 6.
    • “Medtronic asked customers to quarantine three models over reports of problems shaping the malleable materials. The issues could delay procedures or cause cuts to heart tissue.”
  • Per Fierce Pharma,
    • “With a win in a D.C. appeals court, Vanda Pharmaceuticals has earned a point over the FDA in the yearslong face-off between the drugmaker and the drug regulator.
    • “Vanda has been fighting to market its sleep disorder med Hetlioz for jet lag disorder since 2019, when the FDA first rebuffed the bid with a complete response letter (CRL). The company unsuccessfully attempted to dispute the rejection and eventually took the FDA to court after the agency delayed requests for a hearing on the matter.” * * *
    • “Now, the appeals court has agreed with Vanda in a “sweeping win,” setting aside the FDA’s action, Vanda announced in a Monday release. The court determined that the FDA’s “treatment of Vanda’s evidence is cursory” and that each of its trials of Hetlioz in jet lag disorder “showed statistically significant improvement on the primary endpoint measured.”
    • “The court decision throws the ball back in the FDA’s court, where Vanda expects the agency to approve the application or allow a hearing. The company “looks forward to further demonstrating that Hetlioz should be approved to treat jet lag disorder,” it said.
    • “Vanda is no stranger to taking the FDA to court and has done so several times regarding both Hetlioz and other matters. With the latest win against the agency under its belt, the company suggests that other drug manufacturers can do the same.”

From the public health and medical research front,

  • MedPage Today informs us,
    • “The incidence of herpes zoster and herpes zoster ophthalmicus increase after age 50, and both are associated with an increased risk of cardiovascular complications.
    • “For patients ages 50 and older, the adjusted effectiveness of two doses of the recombinant herpes zoster vaccine against herpes zoster ophthalmicus was 72.9%.
    • “The recombinant shingles vaccine also reduced the risks of hospitalization for acute myocardial infarction and stroke.”
  • Patient Care includes the shingles vaccine among the five essential vaccinations for all adults.
  • The Wall Street Journal reports,
    • “A prominent pediatrician group is recommending parents inoculate their young children against Covid-19, diverging from current federal health leaders who have questioned and shifted the guidance for the shots for kids.
    • “The American Academy of Pediatrics, in its immunization guidelines released Tuesday, recommended Covid-19 shots for all children ages 6 months through 23 months. Children in that age group are particularly vulnerable to severe Covid-19 infections and the vaccines would protect them from serious illness, the pediatrician group said. * * *
    • “The CDC now recommends parents of children ages 6 months to 17 years old talk about the risks and benefits of the vaccine with their doctors. The agency previously recommended children and adults ages 6 months and older get Covid-19 vaccines.”
    • “The American Academy of Pediatrics, which has made childhood vaccine recommendations since the 1930s, and other medical groups have criticized the CDC’s shift and sued the Trump administration over these changes earlier this year. The organization has said it has typically collaborated and aligned with the government on vaccination guidance.
    • “The AAP also recommended the Covid-19 shot for individuals ages 2 to 18 if they or people in their household are at high-risk for the severe illness or if they have never been vaccinated, among other considerations. The pediatrician group said children who don’t fall into those categories should have access to the vaccine.”
  • Per a National Institute of Health news release,
    • “The Dietary Approaches to Stop Hypertension (DASH) diet was developed more than 30 years ago by NIH-supported research teams. It was designed to reduce high blood pressure. Studies have since shown that the DASH diet can have positive effects on cardiovascular health and may have other health benefits.
    • A recent study lets us know,
      • “Compared to a typical American diet, a DASH-style eating plan for people with diabetes led to more time with blood glucose in the recommended range.
      • “The results suggest that a modified DASH diet could help control blood sugar levels in adults with type 2 diabetes.”
  • Also check out NIH’s Research Matters which was updated today.
  • Consumer Reports, writing in the Washington Post, notes,
    • “New Dietary Guidelines are expected to be issued this year, and there may be major changes. For the first time, the guidelines advisory committee is recommending that people favor plant protein over animal sources — even those that are considered healthy, such as chicken and fish.
    • “Beans, peas, and lentils would move to the top of the list of protein sources, encouraging people to emphasize those, while red meat moves to the bottom as the protein source you should eat least,” says Christopher Gardner, a professor of medicine at Stanford Prevention Research Center in Palo Alto, California, and one of the committee members.”
    • “The article explains how to eat more plant-based protein.”
  • Health Day points out,
    • “COVID-19 is associated with early vascular aging, as assessed by carotid-femoral pulse wave velocity (PWV), an established biomarker of large artery stiffness, and this association is particularly strong in women, according to a study published online Aug. 18 in the European Heart Journal.” * * *
    • “One of the reasons for the difference between women and men could be differences in the function of the immune system,” [Dr. Rosa] Bruno said in a statement. “Women mount a more rapid and robust immune response, which can protect them from infection. However, this same response can also increase damage to blood vessels after the initial infection.”
  • STAT News reports,
    • “A new oral weight loss drug developed by Viking Therapeutics hit the mark in a mid-stage clinical trial, but the side effect and discontinuation rates have disappointed investors. 
    • “Viking reported Tuesday that its pill, dubbed VK2735, succeeded in a Phase 2 study. The medication led to statistically significant reductions in weight, as much as 12.2% after 13 weeks, on the highest dose of the medication. The company also reported the rate of weight loss didn’t plateau, setting the stage for further weight loss on a longer-term study. 
    • “The rate of gastrointestinal distress was substantial, though. Approximately 38% of the subjects taking the highest dose of VK2735 ultimately discontinued the medication early. Across all of the dose levels, 28% of the trial participants discontinued treatment, compared to 18% of placebo subjects.”
  • Cigna, writing in LinkedIn, explains why “Shared Values and Cultural Backgrounds Matter in Therapy.”
    • “Taking care of your mental and emotional health is just as important as looking after your physical health. Going to therapy can be effective, but how well it works often depends on the kind of connection you have with your therapist. One thing that can really help is when your therapist understands where you’re coming from—culturally and personally.
    • “When you and your therapist share similar values or cultural experiences, you may feel more at ease. You’re more likely to talk honestly, knowing that your therapist understands and respects your background. This helps build trust and makes the whole process feel safer and more supportive.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Employers expect their healthcare costs to increase a whopping 9% next year, which — if the forecast pans out — would represent the largest annual increase in more than a decade, according to a new survey from the Business Group on Health.
    • “Spiking pharmacy spending is fueling much of the cost growth, as are rising incidences of chronic and complex conditions like cancer. Employers expect to lower the cost increase to 7.6% through plan design changes.
    • “But “the story this year is perhaps more daunting and sobering than it has ever been,” Ellen Kelsay, the president and CEO of the BGH, said on a Tuesday call with press.”
  • MedCity News adds,
    • “Market research firm Trilliant Health released research Monday revealing striking differences in the prices providers charge for identical services. The report, which examined data from 2,659 hospitals and 3,491 ambulatory surgery centers, found that commercially insured patients pay widely varying amounts for the same services — and these costs are primarily absorbed by employers. 
    • ‘For instance, it showed that the median rate for a coronary bypass without cardiac catheterization or major complications is $68,194, but negotiated rates ranged from $27,683 to $247,902 — a difference of more than $220,000.”
  • The Milliman consulting firm discusses “approaches to assessing and managing the effects of GLP-1 drugs on health and financial outcomes.”
  • MedCity News considers how interoperability can improve health equity.
  • Fierce Healthcare discusses J.D. Powers’ annual Medicare Advantage plan study.
    • “The highest-scoring plans in the study have robust digital offerings, according to J.D. Power, and most (85%) of the people enrolled in these plans have connected with their member portal. By comparison, 76% of people enrolled in the lower-performing plans used a member portal.
    • “More than half (52%) of people enrolled in the higher-performing plans said the tools offered through their health plan’s website were easy to use.
    • “The study also identified that new members are frequently unsatisfied with the service provided by their plan. Just 38% of first year members said that insurer met their expectations, compared to 45% of established members.”
  • STAT News tells us,
    • “Elaine Chen writes about the limitations of selling drugs directly to consumers. The aim is to lower prices by cutting out insurance companies and their drug middlemen PBMs. 
    • “Some of Trump’s proposals have not been popular with the drug industry, but drug companies are enthusiastic about DTC sales. Some had already started doing so for weight-loss treatments, and others have announced their intention to do so in response to Trump’s demands. 
    • “But the scheme is unlikely to make most drugs more affordable, several health policy and drug pricing experts tell Elaine Chen. Read more for why.”
  • CBS News reports,
    • “Two years after the U.S. Food and Drug Administration approved the first over-the-counter birth control pill, new research is looking at who’s switching to it and why.
    • “In the study, published Monday in JAMA Network Open, researchers used survey data from 986 people, ages 15 to 45, in 44 states who obtained the over-the-counter pill either online or at a pharmacy. They found that a significant portion of users shifted to the over-the-counter pill from a less-effective method of birth control or from using no contraception at all.” * * *
    • “The new research “is one of the first studies to show that over-the-counter birth control pills are reaching the very people they’re meant to help — those who face the greatest barriers to care,” lead author Dr. Maria Rodriguez, professor of obstetrics and gynecology in the Oregon Health & Science University School of Medicine, said in a news release.” 

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.”