Weekend Update

David Ermer

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

Weekend Update

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

Simplicity is a virtue.

From Washington, DC

  • Punchbowl News lets us know,
    • “The Senate is the only game in town on Capitol Hill for the next two weeks, with the House gone already.
    • “The late Sen. Lindsey Graham’s (R-S.C.) memorial service is Tuesday afternoon at National Cathedral. President Donald Trump, Israeli Prime Minister Benjamin Netanyahu and Ukrainian President Volodymyr Zelensky are all expected to attend. There’s also a Capitol Rotunda ceremony on Tuesday morning.
    • “The Senate has a full plate during its two-week sprint to August recess. Senate Majority Leader John Thune is under pressure from competing factions of his conference — and the White House — over the SAVE America Act, reconciliation 3.0, the midterms and much more.”
  • Bloomberg Law reports,
    • “Mehmet Oz [,an MD who administers the Centers for Medicare and Medicaid Services within the Department of Health and Human Services] has been loyal to Health and Human Services Secretary Robert F. Kennedy Jr. while cultivating a close relationship with President Donald Trump and a reputation as a serious operator in the administration.
    • Oz has been playing a significant role in the administration, with access to the president and involvement in various policy discussions, leading to speculation that he could be the heir apparent to lead the health department if Kennedy departs.
    • Despite potential challenges and criticisms, Oz has earned respect from some outside the administration, including major healthcare companies and industry groups, and has been working to implement the administration’s health policies and reduce healthcare costs.

From the public health and medical/Rx research front.

  • The Wall Street Journal relates,
    • “The eyes are a window to the soul, but the mouth may reveal just as much about a person’s health—and the diseases that shape how we age.
    • “To better understand those connections, scientists are studying how issues that start in the mouth may contribute to chronic inflammation elsewhere in the body. In particular, they’re examining how bacteria from diseased gums, and the immune response they trigger, may contribute to conditions including heart disease, diabetes, cognitive decline, arthritis, respiratory disease and chronic liver disease.
    • “The emerging science poses a challenge for healthcare, given the traditional divide between medicine and dentistry—fields that have long been divided by separate training, records and insurance systems. “Dentists haven’t traditionally been trained to think about whole-body health in relation to the mouth, and doctors haven’t been trained to see dental health as a first step to overall well-being,” says Dr. Jessica Lederhausen, a dentist and author of “Oral,” a book exploring the role of lifestyle on oral health.
    • “But that is changing. Dental schools, which have taught how diseases like diabetes affect the mouth, are also placing greater emphasis on how oral disease can affect the rest of the body. Medical-education leaders have called on medical schools to better integrate oral health into physician training.“
  • Newsweek relates,
    • “Air quality alerts spanned large swaths of the western United States on Sunday as wildfire smoke and high ozone levels triggered unhealthy breathing conditions across Oregon, Idaho, Washington, Montana, Colorado, and California.
    • “Data from AirNow, the Environmental Protection Agency’s (EPA) monitoring platform, showed widespread “unhealthy” air or worse, driven primarily by smoke from ongoing fires in Canada and the Pacific Northwest. Officials urged residents in affected zones to remain indoors, limit strenuous outdoor activities, and take precautions if they suffer from asthma, heart disease, or other respiratory ailments.”
    • The primary health threat stems from fine particulate matter, known as PM2.5, which is small enough to penetrate deep into human lung tissue.
  • Columbia University tells us,
    • “If you’re among the hundreds of millions of people now using an AI chatbot on a regular basis, chances are you’ve tried asking it for personal advice. So you know the peculiar comfort that comes from instantly receiving thorough, information-packed takes on your most private concerns, delivered in a warm, affirming tone. “That’s an excellent question and you’re smart to ask it!” a typical chatbot response might begin, whether you’re considering cosmetic surgery or leaving your spouse. “Now let’s think this through, step by step.”
    • “Today, roughly one in three US adults and nearly 20 percent of adolescents are turning to chatbots for personal guidance, seeking insights on everything from relationship problems and workplace conflicts to deeper concerns about anxiety and depression. No one knows yet exactly how this is affecting people, because the phenomenon is so new. But many experts are alarmed. 
    • “People should not be relying on chatbots for emotional support or therapy, that’s for sure,” says Ragy Girgis ’14PH, a Columbia psychiatrist and outspoken advocate for research on the issue. “The technology cannot be trusted to be accurate or helpful in that way.”
  • Oschner Health informs us,
    • “Ultra-processed foods have been a hot topic in wellness conversations, and for good reason. Research continues to link diets high in these foods with anxiety and inflammation, obesity, Type 2 diabetes, heart disease, certain cancers and more.
    • “But this isn’t a story about fear. The goal is not perfection. It’s about awareness — understanding why some foods are so easy to overeat and how small shifts can help protect our long-term health.” * * *
    • Food scientists use the term “bliss point” to describe the “sweet spot” combination of carbohydrate, salt, fat and texture that lights up our brain’s pleasure centers. That combination can make food especially rewarding to eat —and incredibly difficult to stop eating.
    • “For a recent episode of my FUELED Wellness + Nutrition podcast, I [Molly Kimball RD] interviewed Erica LaFata, PhD, a clinical psychologist and researcher whose work focuses on the addictive and reinforcing properties of ultra-processed foods.
    • “This isn’t just about willpower; people aren’t suddenly becoming worse at regulating their eating behavior,” noted LaFata. The food environment itself has changed, making highly rewarding, ultra-processed foods easier to access and consume than ever before.” * * *
    • “This isn’t about obsessing over every ingredient label. It’s about recognizing how these foods are designed and marketed to us so we can make more intentional choices.
    • “LaFata believes that awareness itself can be empowering. It helps us recognize that the issue isn’t simply willpower, but the food environment surrounding us every day.
    • “Small shifts toward whole and minimally processed foods can support overall health. Making intentional choices–even when foods are designed to keep us coming back for more–is a step in the right direction.”

From the U.S. healthcare business front,

  • The New York Times explains “What Geriatric Emergency Departments Do Differently.”
    • “These specialized units can help keep older patients out of the hospital, lower their health care costs and more.” * * *
    • “Since 2017, the American College of Emergency Physicians has accredited 624 such geriatric emergency departments across the United States, including 73 in Veterans Affairs medical centers. “A fairly exponential rate of growth,” said Dr. Kevin Biese, the emergency doctor who directs the Geriatric Emergency Department Collaborative.
    • “Few of these units are restricted to older patients. Instead, like the E.R. in La Jolla [CA], they serve all ages but incorporate senior-friendly practices and protocols in an environment aimed at staving off disorientation, falls and other elder hazards. They’re classified from Level 1, for those fulfilling the highest number of criteria, to Level 3.
    • “Adults 75 and older visit the emergency room at a higher rate than any other age group except infants: 76 visits per 100 people in 2022. Yet standard emergency care “wasn’t correctly designed for the needs of older adults,” Dr. Biese said.”
  • NavigateWell recommends
    • Questions [for employers to ask before your next [health benefits] renewal
      • Before your next renewal, work with your broker to answer these questions and identify where your greatest opportunity for activation exists.
      • Where are employees delaying preventive care or failing to act on identified risks?
      • Are our benefits connected through one experience or expected to work independently?
      • Are we measuring health improvement or simply participation?
      • Which partners are willing to share accountability for outcomes?
      • Healthcare costs will continue to rise. But employers still have an opportunity to influence what happens before tomorrow’s claims are created. The future of employer healthcare strategy requires both.
  • The Wall Street Journal relates,
    • Regeneron REGN Pharmaceuticals co-founder and chief scientific officer George Yancopoulos is more comfortable in a leather jacket than a suit—so much so, his own team had to talk him into wearing one to the White House.
    • “He conceded, but not without adding a colorful tie, hand-painted by Nobel laureate Wally Gilbert. Yancopoulos isn’t one to blend in.
    • “The meeting with President Trump in April was organized in part to tout Regeneron’s latest invention: a gene therapy that restores hearing to children born with a rare genetic deafness, affecting fewer than 50 newborns a year in the U.S. Regeneron—at Yancopoulos’s urging—decided to give it away, free.
    • “We did it to make a statement,” said Yancopoulos, 66. “We want to remind people that when people are sick, you pray for a miracle. And where do they come from? They come from our industry.”
    • “Nearly four decades since he co-founded the biotech Regeneron, Yancopoulos has more than 1,000 patents worldwide, including 77 granted in the U.S., and has authored more than 500 scientific papers. He has turned Regeneron into one of the world’s most valuable drug companies, with a market cap of roughly $70 billion, by repeatedly pioneering technologies that opened up entirely new classes of blockbuster drugs.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

“”We are in the Singularity.” Elon Musk

From the War with Iran front.

  • The American Hospital Association News tells us
    • “The Cybersecurity and Infrastructure Security Agency and other U.S. and international partners July 22 released an updated advisory on Iranian-affiliated cyber actors targeting internet-connected programmable logic controllers, which are computers used to manage and monitor equipment. PLCs can be found in climate control systems, access control systems and many other applications in healthcare. Agencies first warned of malicious activity targeting Rockwell Automation PLCs in April. The updated advisory expands the scope of incidents to include observed targeting of Schneider Electric, Siemens and potentially other manufacturers of PLCs. It also includes new guidance on detecting malicious changes in reusable code modules exploited within Rockwell Automation PLC programs.”

From the Project Glasswing / the Singularity front,

  • Cybersecurity Dive reports on July 22,
    • “Two OpenAI large language models, including one not yet released to the public, broke free of their constraints last week and autonomously hacked into the AI application library Hugging Face.
    • “The first-of-its-kind event, in which the LLMs tried to steal information that would help them excel on an important test, has highlighted the dangers of the AI industry’s increasingly powerful tools.
    • “We consider this incident to be an unprecedented cyber incident, involving state-of-the-art cyber capabilities, and are responding accordingly,” OpenAI said in a blog post on Tuesday that confirmed its models’ responsibility for the attack, which Hugging Face announced on July 16.”
  • AI Strategist David Borish, writing in LinkedIn, lets us know,
    • “On July 21, Elon Musk quote a message from OpenAI researcher Will Depue that laid out a timeline: a security incident at Hugging Face on July 21, a counterexample to the Jacobian conjecture on July 20, the disproof of Erdős’s unit distance conjecture on May 20, the solution to Erdős problem 1196 on April 14, and Anthropic’s Project Glasswing finding thousands of zero day vulnerabilities on April 7. Depue’s post noted that in “normal” times, these milestones would have been spread across months or years. Compressed into a single week of news cycles, they read differently. Musk’s reply ran five words: “We are in the Singularity.”
    • “The claim landed hard because, unlike most Singularity talk, this timeline is not speculative. Each item is a documented event with a paper trail, and the details matter more than the framing.” * * *
    • “The skeptical case. Grocery prices, commute times, and most people’s jobs look the same this week as they did a month ago. Every event on Depue’s timeline required a human to set up the evaluation, pose the conjecture, or prompt the model, and in most cases required teams of human experts to verify, formalize, or clean up afterward. Deep learning researcher Yann LeCun has argued current architectures will not reach general intelligence without a different approach entirely. Writer Freddie deBoer has made the broader point that a self-improving AI escaping human oversight remains a speculative scenario without a demonstrated mechanism, distinct from AI systems getting better at specific tasks people assign them.
    • “Both things can be true at once. The rate of capability progress across math, security research, and coding is genuinely compressing what used to take years into weeks, and the humans setting the objectives, verifying the outputs, and deciding what gets deployed have not gone anywhere. The more telling test ahead is quieter than another isolated proof or another leaderboard topper: whether formal verification, in Lean or otherwise, keeps pace with the rate of claims, and whether the containment failures at Hugging Face turn out to be a one time embarrassment or the first entry in a longer list.”
  • TechTimes adds,
    • “Microsoft is preparing to launch Project Perception, an AI-powered security platform that scans enterprise codebases for exploitable vulnerabilities — and is built around a deliberate cost-and-access argument against Anthropic’s Claude Mythos Preview, the most capable vulnerability-hunting AI available and one that most organizations on Earth cannot currently use.
    • “The platform is expected to debut before the end of July. It routes security analysis tasks across AI models from Microsoft, OpenAI, and Anthropic, using a model-selection layer that reserves expensive frontier model calls for the steps where they create real value and assigns cheaper, distilled models to high-volume scan passes. That architecture, according to reporting first published by The Information, is designed to bring the cost of running continuous, enterprise-grade vulnerability discovery well below what Anthropic charges for direct Mythos access.”

From the cybersecurity policy front,

  • Federal News Network reports,
    • “The unprecedented breach of a technology vendor by autonomous artificial intelligence agents is serving to underscore governmentwide efforts to streamline federal cloud security and prioritize faster patching of critical software vulnerabilities.
    • “OpenAI confirmed this week that its advanced AI training models broke out of their test environment and then hacked into the networks of start-up vendor Hugging Face. The incident is the latest AI cybersecurity development driving policy conversations across Washington.
    • “Pete Waterman, director of the Federal Risk and Authorization Management Program (FedRAMP) at the General Services Administration, pointed to the Hugging Face incident as a landmark moment for cybersecurity during Carahsoft’s FedRAMP Summit on Thursday.
    • “Waterman said the incident underscores his program’s shift to the FedRAMP 20x model.”
  • Cyberscoop relates,
    • “Industry groups who spoke at town halls hosted by the Cybersecurity and Infrastructure Security Agency [(CISA)] about a pending cyber incident notification regulation had a few consistent messages:
    • “We want this to apply to fewer of us. We don’t want to report to you on as many incidents. We want to give you less information when we do. 
    • “CISA last week published transcripts from the town halls, where the agency sought feedback on the delayed rule for the 2022 Cyber Incident Reporting for Critical Infrastructure Act — perhaps the most significant cyber legislation Congress has ever passed. That law required critical infrastructure owners to report major cyberattacks to the federal government within 72 hours, and ransomware payments within 24 hours.” * * *
    • “Where the rule specifies what kind of data organizations should report in a major incident, CISA should “seek to collect the least amount of information possible in the easiest to report fashion to facilitate information accuracy and reporting speed,” said Samantha Burch, vice president of technology public policy at government affairs at AHIP, a health insurance industry trade association.” * * *
    • “One industry representative told CyberScoop that CISA’s willingness to hold town halls, combined with the Trump administration strategy emphasizing “common sense regulation,” was a good sign about where the rule might be heading.
    • ‘They are not picking up on the Biden administration’s approach and tweaking it. They’re thinking, ‘What are the specific pieces of information we need during a cyber incident to help critical infrastructure companies respond?’” said Henry Young, senior director of policy for the Business Software Alliance. “In general, industry is optimistic that what we’ll end up with are a few of the most important pieces of information, so that in the emergency, companies can act quickly and actually respond to an incident rather than completing lots of paperwork.”
  • and
    • “Seven out of 10 federal cyber regulations requiring written reports to federal agencies are duplicated elsewhere, a report from a government watchdog found in a report to Congress Wednesday.
    • “And so far, efforts to de-conflict haven’t had much success, the report from the Government Accountability Office concluded.
    • “At the request of two top lawmakers, the GAO examined federal cyber regulations at 37 agencies. It counted 80 out of 117 rules that “either contain the same kind of reporting requirement applicable to a sector or the same reporting requirement as at least one other regulation.”
    • “The desire to harmonize those conflicting rules gathered steam under the Biden administration, as it undertook a more aggressive push to regulate cybersecurity than prior administrations. It has continued into the second Trump administration.”

From the cybersecurity breaches and vulnerabilities front,

  • HIPAA Journal reports,
    • “There has been a general trend of increasing data breaches over the past decade, with this year on track to set a new record. According to the H1 2026 Data Breach Report from the Identity Theft Resource Center (ITRC), there have been at least 1,803 data compromises in H1 2026, which will give an annual total of more than 3,600 data compromises if they continue to occur at a similar rate as the first half of the year.
    • “Across those data compromises, there have been 1,394 confirmed data breaches (excluding leaks, exposures, and unknown incidents), accounting for 77% of total events. More than 471 million victim notices have been issued, which already exceeds the total number of victim notices for all of 2025, and there are still six months of the year to go. While at the current rate, this year is unlikely to beat the total for 2024, even with only 6 months of data, 2026 already ranks as one of the worst years to date.
    • “As ITRC explains in the report, part of the reason is the return of mega data breaches, the biggest of which involved the Instructure Holdings’ Canvas platform, which accounted for an estimated 275 million notices. A mega data breach at Under Armour involved more than 72.7 million notices, while the SoundCloud data breach saw 29.8 million victim notices issued.
    • “There were no healthcare data breaches in the top 10 data compromise list, in contrast to H1, 2025, when three healthcare data breaches made it into the top 5. In fact, based on breach reporting to the HHS’ Office for Civil Rights, there have been relatively few mega data breaches in healthcare. In H1 2026, only 7 healthcare data breaches required more than 1 million notices.”
  • Dark Reading relates,
    • “Russian state-backed threat actors are compromising networks of Western governments and enterprises through the Zimbra Collaboration Suite (ZCS), according to intelligence and cybersecurity agencies in more than a dozen countries.
    • “In a joint advisory Thursday, the US government and several allied nations warned that an advanced persistent threat (APT) dubbed “Laundry Bear” has been targeting ZCS customers since July 2025. Laundry Bear actors used a zero-day vulnerability in ZCS, tracked as CVE-2025-66376, in a phishing campaign that featured what experts describe as a “half-click exploit” to breach Zimbra webmail servers.
    • “Unlike traditional phishing campaigns that persuade a user into taking an action, such as clicking a link or opening a file, Laundry Bear’s latest campaign leverages a view-based exploit that only requires a user to view a malicious email within a vulnerable version of the webmail service,” the agencies said in the advisory.
    • The campaign is designed “almost certainly to gather sensitive information for the Russian Federation,” according the advisory. The Laundry Bear attacks mark yet another threat from Russian APTs against US organizations.
  • Cybersecurity Dive tells us,
    • “A critical vulnerability in Check Point Software’s SmartConsole login process is being exploited, with a small number of customers already impacted, according to a security advisory released Wednesday from the company. 
    • “The authentication bypass flaw, tracked as CVE-2026-16232, allows an attacker to gain full administrative privileges after they access an application login token. An attacker can then make changes to security policy and configurations. The vulnerability has a severity score of 9.1 out of 10. 
    • Check Point on Wednesday released a jumbo hotfix to address several security issues in its firewall and management products, according to the advisory.
    • A vulnerability of this type is particularly concerning, giving an attacker the ability to make a number of changes, according to a blog post released Thursday by Rapid7. A remote hacker can “alter administrator permissions, manipulate VPN configurations, and potentially disable or tamper with logging and monitoring,” Rapid7 said. 
  • and
    • “A critical-severity deserialization vulnerability in Microsoft SharePoint is now under exploitation, according to security researchers at watchTowr and Defused. 
    • “The flaw, tracked as CVE-2026-50522, has a severity rating of 9.8 out of 10 and could enable an attacker to execute remote code over a network. 
    • “Hackers are targeting on-premises SharePoint server environments following the release of new exploit code, watchTowr researchers said in a LinkedIn post. Researchers warned that attackers are stealing machine keys to maintain long-term access.”
  • CISA added six known exploited vulnerabilities to its catalog this week.
    • July 21, 2026
      • CVE-2021-27137 DD-WRT Stack-Based Buffer Overflow Vulnerability
      • CVE-2026-0770 Langflow Inclusion of Functionality from Untrusted Control Sphere Vulnerability  
      • CVE-2026-63030 WordPress Core Interpretation Conflict Vulnerability  
      • CVE-2026-60137 WordPress Core SQL Injection Vulnerability
        • Security Affairs discusses these KVEs here.
    • July 22, 2026
      • “CVE-2026-16232 Check Point SmartConsole Improper Authentication Vulnerability
        • The Hacker News discusses this KVE here.
      • “CVE-2026-50522 Microsoft SharePoint Deserialization of Untrusted Data Vulnerability
        • Cybersecurity Dive discusses this KVE here.
  • Cyberscoop adds,
    • “Malware targeting AI coding assistants and software developers’ automated workflows is spreading into more environments with more capabilities, placing defenders at a growing disadvantage.
    • “A malware strain dubbed Sandworm_Mode, first discovered by Socket in February, represents a growing threat to software development. According to a CrowdStrike report, the self-propagating worm can spread through code repositories with minimal detection, raising alarms about software supply chains.
    • “The malware’s capabilities are extensive, but not especially unique compared to the series of supply-chain worms known as Shai-Hulud, and more recently Mini Shai-Hulud.
    • “This is the new trend,” Adam Meyers, senior vice president of counter adversary operations at CrowdStrike, told CyberScoop. “This is something we’re seeing more and more. It’s the new hotness right now.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “A threat group called Anubis claimed credit for the ransomware attack against Fairlife, the dairy products unit of Coca-Cola. 
    • “The group says it locked the servers at Fairlife and obtained 1TB of data from the attack, according to researchers at Arctic Wolf. Anubis is threatening to leak information if its demands are not met within a week. Researchers provided screenshots posted on the group’s data leak site
    • “Coca-Cola was forced to suspend U.S. production at Fairlife while it launched an investigation into the attack. Coca-Cola officials noted there was no impact on the safety or quality of its dairy products.” “
  • Dark Reading relates,
    • “Ransomware is not just growing, it is actually accelerating, with activity surging between October 2025 and March 2026, as more than 60 new groups entered an increasingly crowded criminal ecosystem.
    • “For enterprises, the surge means not only more attacks but also a larger and constantly changing pool of adversaries to track and defend against.
    • “Black Kite analyzed ransomware incidents between April 1, 2025, and March 31, 2026, and identified 7,551 known victims worldwide. That represented a 25% increase over the previous 12-month period, with much of the growth concentrated in the second half of the year. Black Kite counted 2,904 victims between April and September 2025 and 4,647 between October 2025 and March 2026, marking a 60% increase in reported ransomware victims. March 2026 was the busiest month with as many as 861 organizations — or nearly 28 per day — falling victim to a ransomware attack.
    • “This isn’t a problem we’ve contained,” says Ferhat Dikbiyik, chief research and intelligence officer at Black Kite. “It’s still a lucrative business, and the barrier to running one keeps getting lower.”
  • The Hacker News tells us,
    • “Threat actors have been observed exploiting a now-patched high-severity Palo Alto Networks PAN-OS vulnerability as an entry point to deploy Qilin (aka Agenda) ransomware on victim environments.
    • Arctic Wolf Labs said it investigated multiple intrusions in June 2026 that began with the exploitation of CVE-2026-0257 (CVSS score: 7.8), an authentication bypass flaw affecting the portal and gateway components of PAN-OS software.
    • Successful exploitation of the flaw allows unauthenticated remote attackers to sidestep authentication and establish VPN sessions without valid credentials when authentication override cookies are enabled with specific certificate configurations.
    • “Post-exploitation tradecraft varied across intrusions, from rapid encryption-only operations to full double-extortion, possibly suggesting multiple affiliates operating under the Qilin ransomware-as-a-service (RaaS) umbrella,” the cybersecurity company said.
  • Bleeping Computer points out,
    • “The Clop ransomware gang (also tracked as Cl0p) is targeting Internet-exposed PTC Windchill and FlexPLM instances in a new data theft extortion campaign.
    • “Clop has reportedly been exploiting a critical improper input validation vulnerability tracked as CVE-2026-12569, which allows attackers to execute arbitrary code on vulnerable Windchill and FlexPLM instances.
    • “As cybersecurity company ReliaQuest reported on Thursday, Clop operators have been deploying JSP webshells that allow them to exfiltrate sensitive data from targeted companies’ compromised PLM platforms.
    • “ReliaQuest has observed threat actors actively exploiting CVE-2026-12569, a critical unsafe deserialization vulnerability (CVSS 9.3) affecting PTC Windchill and FlexPLM. Exploitation enables unauthenticated remote code execution and JSP web shell deployment for remote command execution and sensitive product data exfiltration,” the company said.”
  • Per Cisco Talos,
    • “Cisco Talos has discovered a new Rust-based remote access trojan (RAT) we call “msaRAT” attributed to the Chaos ransomware group. The name is derived from the binding names found in the binary: “msaOpen,” “msaClose,” “msaError,” and “msaMessage”.
    • “msaRAT is implemented using the Tokio asynchronous runtime, with primary capabilities of browser-leveraged remote code execution and covert tunneling to establish command-and-control (C2) communications.
    • “This RAT never touches the network directly — it controls its C2 communication channel exclusively through Chrome DevTools Protocol (CDP), a browser debugging API. The binary contains a Cloudflare Workers endpoint, but it never makes HTTP connections to that domain itself; it offloads that work entirely to the browser.
    • “msaRAT manipulates the browser via CDP, performs signaling (SDP Offer/Answer exchange) with Cloudflare Workers, and establishes a WebRTC DataChannel between the browser and the C2 server using Twilio TURN (Traversal Using Relays around NAT) as a relay.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • “The Defense Department signed an up to 10-year, near $7 billion contract with Oracle intended to streamline fragmented licensing and intra-agency efficiency.
    • “The Austin-based cloud computing and software company separately maintained different contracts across the agency. The government said the deal will optimize services and deliver hundreds of millions of dollars in taxpayer savings.”
  • TechCrunch relates,
    • “Glow, a cybersecurity startup founded by former Meta and Snowflake executives, emerged from stealth as a unicorn, betting that artificial intelligence is reshaping how enterprises secure employee devices.
    • “The Palo Alto-headquartered startup on Wednesday said it raised $180 million in an all-equity Series A funding round that valued it at $1.2 billion, with backing from Sequoia Capital, Cyberstarts, Greenoaks, and Redpoint Ventures, alongside participation from Index Ventures, Swish Ventures, Lux Capital, Operator Collective, and Holly Ventures. The investment made Glow one of the latest cybersecurity startups to achieve unicorn status before publicly disclosing revenue metrics.”
  • Cybersecurity Dive relates,
    • “Many ransomware victims remain vulnerable to follow-up cyberattacks, even after they complete their incident response processes, highlighting gaps in mitigation activities that increase their odds of becoming repeat targets, the security firm Black Kite said on Tuesday in its annual ransomware report.
    • “The report described how victims fail to patch critical vulnerabilities and properly configure email security tools, underscoring the importance of thorough digital cleanup operations as part of the ransomware recovery period.” * * *
    • “Black Kite also shared fresh data on the ransomware ecosystem and its top targets.”
    • Because ransomware is a profit-motivated business, cybercriminals prioritize the easiest and most lucrative targets, and if an organization fails to fix the problems that opened the door for hackers in the first place, they are likely to return. That fact makes it imperative for hacked businesses to fix digital liabilities as soon as possible after an incident, lest hackers revictimize them seeking another payout.
  • MSN adds, “The next cyber arms race isn’t about finding bugs. It’s about fixing them first.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., defied expectations and kept his fractured conference together to pass several priority items before House members jetted home on Thursday to kick off a five-week recess. 
    • “But how much of that legislation their colleagues in the Senate will take up is a different question, as divisions continue to deepen.
    • “The House adopted a GOP-backed budget resolution along party lines on Wednesday, taking the first step toward passing a $95 billion reconciliation package that’s focused mostly on the Iran war. 
    • “But Senate Majority Leader John Thune, R-S.D. has remained lukewarm on such a package, especially if it includes certain aspects of the so-called SAVE America Act, which would require proof of citizenship to register to vote and photo ID at the polls. 
    • “I can’t count 50 right now on a budget resolution,” Thune told reporters on Thursday. He said the path to clearing the chamber’s so-called Byrd bath, which assesses compliance with reconciliation rules, “is still an open question.”
  • Beckers Clinical Leadership relates,
    • “HHS has rewritten the governing charters for the Advisory Commission on Childhood Vaccines and the National Vaccine Advisory Committee.
    • “The ACCV charter, filed July 21, removes the standalone designated federal officer section that appeared in the previous version, which specified that a full-time federal employee would approve meeting agendas, call meetings and maintain public-facing information on the committee’s activities.
    • “In its place, the new charter refers more broadly to “the federal official responsible for ACCV oversight” calling or approving meetings. The revised charter also adds a provision allowing that federal official, if appointed by the HRSA administrator, to serve as temporary chair if ACCV members have not selected a chair and vice chair. The ACCV advises the HHS secretary on the National Vaccine Injury Compensation Program, including changes to the Vaccine Injury Table and how the government collects and uses vaccine adverse event data.
    • “The revised NVAC charter adds duties not previously included in the panel’s purview, directing members to weigh what it terms “non-immunization strategies,” including healthy lifestyle and disease prevention initiatives, off-label use of already approved drugs and dietary supplements marketed for immune support.”
  • Govexex tells us,
    • “The National Active and Retired Federal Employees Association on Thursday said the Office of Personnel Management still has not sufficiently protected federal workers and retirees as part of a plan to collect claims-level health data in an effort to root out fraud.” * * *
    • “[I]n a letter to [OPM Director Scott] Kupor Thursday, NARFE National President William Shackelford said that while his organization appreciates the steps taken thus far to shield FEHBP and PSHBP participants’ identities, he remains troubled by OPM’s insistence that it be able to re-identify employees via their health records in the future. Under the Health Insurance Portability and Accountability Act, health care data should be not just pseudonymized, but de-identified entirely, he wrote.
    • “NARFE’s position is straightforward. OPM has moved in the right direction,” Shackelford wrote. “But we asked for de-identified data and OPM has offered pseudonymized data, and those are not the same commitment. Pseudonymization does not remove the risk that our members’ health information will be linked back to them; it makes that linkage a matter of OPM’s discretion, exercisable by whoever holds the relevant authority in any future administration.”
    • “Additionally, most of OPM’s reassurances about privacy and the data collection’s anti-fraud purpose exist solely within Kupor’s blog post, and not the proposal published in the Federal Register last month.”
  • Over 700 public comments were submitted by yesterday’s deadline. As the FEHBlog has noted, OPM is not giving FEHB and PSHB carriers and the OPM Inspector General credit for preventing most fraud, waste and abuse in these programs.
  • The American Hospital Association News informs us,
    • “The U.S. Trade Representative yesterday announced it is implementing a 10% or 12.5% tariff on 60 trading partners, which became effective today. These tariffs follow an investigation under Section 301 of the Trade Act of 1974 for lacking or failing to enforce a ban on goods produced with forced labor, according to the agency. Nations that the USTR said had made commitments to adopt and effectively enforce forced labor import prohibitions will receive a 10% tariff, while nations that the agency said had failed to adopt a forced labor import ban will receive a 12.5% tariff. The USTR notice outlines which products are excluded from the new tariffs, including products already subject to Section 232 tariffs, products qualifying under the U.S.-Mexico-Canada trade agreement and certain pharmaceuticals and pharmaceutical ingredients.”
  • and
    • “The Consumer Product Safety Commission yesterday announced it is modernizing the National Electronic Injury Surveillance System, the national database for tracking consumer product-related injuries. The CPSC said that it will replace its manual coding process, used since 1972, with an electronic data exchange through a Qualified Information Network. The new system, NEISS-Remodel, will expand the network to all 50 states, up from 36 under the previous system. NEISS-R is expected to become fully operational by the beginning of 2027.” 

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • It’s been over two months since Dr. Marty Makary stepped down from his post as FDA commissioner, and there has yet to be visible progress toward naming his permanent successor. The gap in leadership is sparking concerns among industry watchdogs that pharma could lack clear guidance on federal priorities for weeks or months to come.
    • The Trump administration has yet to name a nominee to replace acting commissioner Kyle Diamantas — and there are currently multiple hurdles in front of any confirmation process. In particular, the Senate isn’t going to be around much in the coming months. 
  • The Wall Street Journal relates,
    • “Biohackers, longevity enthusiasts and alternative medicine doctors want the peptide BPC-157. Now compounders may be one step closer to lawfully providing it. 
    • “The Food and Drug Administration’s Pharmacy Compounding Advisory Committee voted in favor of easing restrictions on six of seven peptides up for consideration, following strong warnings from the agency’s scientists. It’s now up to the FDA to decide whether to greenlight the drugs for compounding pharmacies to make—and pave the way for a peptide gold rush.
    • * * * “The committee voted against one peptide called Emideltide, evaluated for opioid withdrawal, chronic insomnia, and narcolepsy. David Pope, a pharmacist who voted affirmatively for other peptides, voted “no” on this one, citing a complex regimen and “potentially dangerous downstream consequences.”
  • USA Today tells us,
    • “Consumers will soon have a new over-the-counter pain relief option that combines Tylenol with naproxen, an anti-inflammatory medication.
    • “The Food and Drug Administration on July 24 approved the non-prescription combination of 650 mg of Tylenol (acetaminophen) and 220 mg of naproxen sodium.
    • “The non-opioid tablet can be used by adults and children aged 12 and ​older for temporary relief of headaches, back pain, muscle aches, toothache, menstrual cramps and minor pain from arthritis, the FDA said.
    • ‘Kenvue, which owns Tylenol, said the tablet combination will soon be available for purchase without a prescription at major retailers.”
  • Fierce Pharma informs us,
    • “With all eyes on Tavneos’ seemingly precarious approval status in the U.S., Amgen is advancing plans to defend the ANCA-associated vasculitis (AAV) drug it inherited in its $3.7 billion buyout of ChemoCentryx. 
    • “The California pharma on Thursday submitted data and analyses to the FDA to help secure a hearing in hopes of keeping Tavneos on the U.S. market. The package includes a third-party re-evaluation of the med’s controversial pivotal trial, real-world evidence and patient and HCP testimonials.
  • Cardiovascular Business lets us know,
    • “Penumbra is recalling specific lots of its RED 68 Perfusion Catheter due to an ongoing safety concern. 
    • “The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall. This means using the device without following the manufacturer’s recommendations could lead to “temporary or medically reversible adverse health consequences.” 
    • ‘The recall was put in place due to a risk of the catheters fracturing. Penumbra has said “manufacturing issues” are to blame, but the company is still investigating the issue to learn more.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 24, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Considering multiple data sources, COVID-19 activity is low and stable nationally but is beginning to show early signs of an increase in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) is elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The American Hospital Association News reports,
    • “There have been 2,318 confirmed measles cases in the U.S. so far this year, the most in the country since 1991, according to the latest data from the Centers for Disease Control and Prevention. There were 2,289 cases in 2025. Cases this year have been reported by 45 jurisdictions. The CDC said that 93% of cases are outbreak-associated. The vaccination status of 93% of cases is unvaccinated or unknown. The agency said that 7% of cases this year have been hospitalized, lower than last year’s figure of 11%.”
  • The Washington Post offers an opportunity to check out your county’ measles vaccination rates for kindgarteners.
    • “The share of U.S. counties where 95 percent or more of kindergartners were vaccinated against measles — the number doctors say is needed to achieve overall protection for the class, known as “herd immunity” — has dropped from 50 percent before the pandemic to 28 percent, according to The Post’s examination of the public records from 44 states and the District of Columbia.”
  • The Wall Street Journal tells us,
    • “Public-health officials are investigating four additional states as part of a multistate cyclospora outbreak linked to iceberg lettuce that they warn could be even broader.
    • Illinois, Kansas, Oklahoma and Pennsylvania are the latest states added to the investigation, the Centers for Disease Control and Prevention said Friday. The health agency said last week it was investigating the outbreak in Indiana, Kentucky, Michigan, Ohio and West Virginia. 
    • “The CDC said epidemiologic data continued to show the outbreak stemmed from the consumption of iceberg lettuce from Taylor Farms. Nearly 2,000 people who ate food from Taco Bell have been sickened in those nine states during the outbreak, the agency said. Nearly 100 people have been hospitalized. 
    • “The iceberg-lettuce outbreak might be even broader than what health authorities have found. The authorities are investigating a number of food-related outbreaks, including several involving cyclospora, a parasite that causes explosive diarrhea. For now, the authorities are probing the various cyclospora outbreaks as if they are distinct, but it is possible they are related and investigators so far haven’t been able to connect them.”
  • and
    • “Warmer winters and changes in land use are driving ticks carrying Lyme disease and alpha-gal syndrome into new areas such as Ohio and Michigan.
    • “In 2025, Lyme disease cases jumped more than 60% in Ohio and almost 80% in Michigan as blacklegged tick populations expanded.
    • “Lone-star ticks, which cause the meat allergy alpha-gal syndrome, are established in 19 counties in Ohio and five in Michigan.”
  • The New York Times points out,
    • “The same chemical process that turns a baking cake golden brown is at work aging your body’s cells. Over decades, your tissues, baking steadily at 98.6 degrees, slowly accumulate compounds called advanced glycation end products, or AGEs, as sugars interact with protein and fat in the bloodstream. The buildup of AGEs is a hallmark of the aging process, making tissues like collagen sticky and rigid and causing inflammation that can lead to heart disease, eye damage, kidney disease and diabetes.
    • “Researchers have tried unsuccessfully to develop medications that can stop AGEs from forming. But a new study, published on July 16 in the journal Nature Communications, describes a different tack: Scientists created an enzyme that cleans one of the most common AGEs from human tissue, helping to turn back the clock even after the aging compounds have settled in the body. This cleanse can help repair the tissue and has the potential to allow cells to act younger.
    • “It’s a small step in this bigger direction, because aging is very complicated,” said Aaron Cravens, a founder and the chief executive of Revel Pharmaceuticals, which developed the new enzyme, and the lead author of the study. “It’s the first time, I think, that anyone in the field has shown at the structural level that you can actually reverse some of these changes.”
  • MedPage adds,
    • “Exceptional memory at age 80 and beyond was not due simply to good genes, an analysis of prospective data suggested.
    • “The study assessed outcomes for superagers — people 80 or older with episodic memory at least as good as adults 20 or 30 years younger — and cognitively average controls.
    • “Genotype distributions and APOE status did not differ between groups, reported Ignazio Stefano Piras, PhD, of the Translational Genomics Research Institute at City of Hope in Phoenix, and co-authors.
    • “Neither APOE nor any of three polygenic risk scores predicted whether a person would be a superager, Piras and colleagues wrote in Alzheimer’s Research & Therapy. Results were similar after accounting for global non-European or African ancestry.”
  • Health Day informs us,
    • “About 50% to 88% of children with autism experience motor skill challenges
    • “Organized sports — especially martial arts and aquatic training — can improve motor skills
    • “Consistently large improvements were seen in balance, coordination, overall motor skills and object control.”
  • and
    • “Increases in a problematic social media use may contribute to worsening attention-deficit/hyperactivity disorder (ADHD) symptoms during adolescence, particularly among boys, according to a study published online July 17 in JAMA Network Open.”
  • The Wall Street Journal notes,
    • “Ipsen said its drug Bylvay missed the primary objective in a late-stage clinical trial for biliary atresia, a rare liver disease affecting babies.
    • “Bylvay missed the study’s primary objective of showing an improvement in native liver survival rates compared to a placebo, Ipsen said.
    • “Ipsen said biliary atresia, the leading cause of pediatric liver transplants, has no approved therapeutic options beyond surgery or transplant.”
  • Per BioPharma Dive,
    • “Sanofi is calling it quits on an experimental eczema drug that it had seen as a potential successor to its blockbuster medication Dupixent, according to a Friday announcement.
    • “Sanofi had said in January that it intended to seek clearance of the drug, amlitelimab, in atopic dermatitis despite mixed late-stage study results and signs of possible safety concerns. On Friday, though, the French pharmaceutical firm said that, during a pipeline review, it found that the “totality of efficacy and safety evidence generated to date” doesn’t support further development of amlitelimab in that indication.
    • “Sanofi’s decision follows a recent move by Amgen and Kyowa Kirin to shelve a similar experimental medicine. The pharma company will continue testing amlitelimab in celiac disease, though, and is slated to reveal data from a mid-stage study by the end of the year.”

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

  • Fierce Healthcare reports,
    • “HCA Healthcare on Friday affirmed its earlier warnings about Affordable Care Act (ACA) exchange subsidies fallout, telling analysts that patients who dropped off marketplace plan coverage due to increased premiums have “migrated almost one for one” to uninsurance. 
    • “The country’s largest for-profit brought in $20.23 billion in second-quarter revenue, up 8.7% year-over-year, net income of $1.69 billion, up 2.8%, and adjusted EBITDA of $4.027 billion, up 4.6%, according to financial results published Friday morning. The company also reported diluted earnings per share increasing 11.6% to $7.62 per share.
    • “In particular, a payer mix shift driven by increased uninsured volumes had an “unfavorable impact” on income of approximately $400 million before income taxes, above its estimates from earlier in the year.”
  • and
    • “Clinician-led artificial intelligence platform Anterior and health tech company Stellarus entered a strategic partnership Thursday to tackle automating prior authorizations.
    • “The partnership aims to support providers through automating tasks—such as case research and policy application—to allow teams to focus on complex determinations. The companies say providers will receive quicker, first-time approvals, ultimately giving members quicker care access. 
    • “Stellarus provides the healthcare technology platform, integration expertise and operational experience to help health plans put AI into practice, while Anterior brings leading clinical AI to automate the research, documentation and policy application that support prior authorization,” said Vanessa Colella, Stellarus president and CEO.”
  • and
    • “Addressing healthcare’s biggest challenges will require payers and providers working together.
    • “That’s why the team at Aetna has spent the past several years investing in ways to bridge those trust gaps and better unite the two sides of the industry that are often at odds. And a new survey suggests that work is paying off.
    • “Morning Consult polled 723 provider executives across multiple disciplines on Aetna’s behalf, and found an average provider trust score of 6.1 on a scale of one to 10. By comparison, a similar poll conducted in the first quarter found a 5.4 trust score.”
  • Modern Healthcare relates,
    • “Surgery Partners plans to sell its ownership interest in two Idaho hospitals to Intermountain Health.
    • ‘The proposed transaction, which values the facilities at an estimated $1.15 billion, would include Surgery Partners’ Idaho Falls Community Hospital and Mountain View Hospital, also in Idaho Falls, along with affiliated clinics.
    • “Surgery Partners is expected to receive about $795 million in the transaction, according to a Friday news release.”
       
  • MedTech Dive tells us,
    • “Edwards Lifesciences reported strong sales of its heart valves in the second quarter and outlined several upcoming catalysts expected to maintain solid growth rates, starting with an anticipated Medicare coverage expansion.
    • “Sales were better than the company expected for transcatheter aortic valve replacement devices, Edwards’ largest product line, as well as newer repair and replacement treatments for mitral and tricuspid diseases, due to increasing clinical demand, executives said on a Thursday earnings call.
    • “CEO Bernard Zovighian tied TAVR demand to growing evidence backing earlier use of the procedure to treat aortic stenosis patients and predicted the “durable” momentum would support the company’s 10% total sales growth target long term.”
  • Fierce Pharma informs us,
    • “After a post-[July 4th] holiday lull, prescriptions for GLP-1s have more than bounced back. Weekly prescriptions for Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo reached new highs during the previous week, collecting 169,800 and 26,760, respectively, according to IQVIA data cited by Citi. The two oral drugs’ previous records were about 161.5K and 24.3K, respectively. 
    • “Other GLP-1 drugs also enjoyed a boost, as total GLP-1 scripts across obesity and diabetes increased 6.6% sequentially, according to Citi.
    • “Against this backdrop, Lilly’s oral Foundayo seemed to enjoy a small inflection point, with a total 24,303 scripts notably breaking away from its roughly 20K level in the prior five weeks.  
    • “Meanwhile, joining the bigger trend, Wegovy pill scripts dropped to 147.5K during the week, versus about 153K the prior week or 161.5K at its peak. But the contribution of the oral version to the overall Wegovy scripts remained stable at around a third, per Citi’s note.” 

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • Bloomberg Law reports,
    • “The health insurance industry is adding to scrutiny of the American Medical Association’s control of billing codes, voicing resistance to the group’s planned overhaul of how doctors bill health plans for maternity care.
    • “Insurers say they didn’t have enough time to prepare for the change, while AMA claims the industry didn’t raise concerns during the development process. The dispute is gaining attention from policymakers amid a broader political rift between the AMA and Republicans over the country’s healthcare billing system.
    • “The AMA develops and trademarks the Current Procedural Terminology, or CPT, codes that doctors use to bill insurers for medical services. The codes are baked into government programs like Medicare, and critics—as well as Medicare’s payment advisory panel—have long questioned the conflict of interest in letting AMA help determine doctors’ payments.” * * *
    • “Overall, the new protocol eliminates 17 codes in favor of 12 new codes and six revised codes. AMA developed the codes over the course of three years with its CPT panel, which includes seats for representatives nominated by health insurance trade group AHIP and the Blue Cross Blue Shield Association. The codes were released in April, before the typical September release, to give everyone more time to prepare.
    • “But insurers say it’s not enough, pointing to the fact that babies due to be born in 2027 are already on the way. And while insurance representatives serve on the panel, participants are legally blocked from sharing information about the meetings, according to AHIP.” * * *
    • “The Centers for Medicare & Medicaid Services last week proposed extending the current coding system for an additional year alongside the new codes, saying it’s concerned the change will be disruptive.”
  • Beckers Payer Issues relates,
    • “Committees in the House and Senate each advanced healthcare price transparency legislation this week, both aiming to expand disclosure requirements for hospitals, insurers and other healthcare providers.  
    • “Both measures would expand the existing hospital and payer price transparency rules, bring ASCs and labs under similar mandates for the first time and add new reporting requirements for insurers, pharmacy benefit managers and health plan administrators, though they differ on penalty structures, effective dates and scope.” * * *
      • Patients Deserve Price Tags Act
        • “The Senate Committee on Health, Education, Labor and Pensions advanced legislation July 22 that would implement new price transparency requirements for hospitals, insurers, laboratories, imaging providers and ASCs, while also expanding group health plans’ access to claims and reimbursement data held by insurers and PBMs.
        • “The committee passed the Patients Deserve Price Tags Act by a vote of 21-1, one of several healthcare bills advanced together in the same en bloc vote. The bill now heads to the full Senate.
      • The Lower Costs, More Transparency Act
        • The House Energy and Commerce Committee advanced a broad healthcare price and cost transparency package July 21 in a 45-0 vote that would also expand price transparency rules for hospitals, insurers, ASCs and the administrators of employer-sponsored health plans if signed into law.
        • The bill was also referred to the House Ways and Means and Education and Workforce committees.
  • The Hill adds,
    • “Bipartisan legislation to cap the cost of insulin at $35 for people with private health insurance advanced through a key Senate committee Wednesday, but its future remains uncertain. 
    • “The measure cleared the Senate Health, Education, Labor and Pensions [HELP”] Committee by a bipartisan 17-5 vote, with six Republicans joining every Democrat on the panel.” 
  • STAT New notes,
    • “People with diabetes who use a popular long-acting insulin pen made by Sanofi have had to become pharmacy scouts in recent weeks as they encounter supply issues.
    • “The Lantus Solostar pen containing 3 milliliters of insulin glargine has been running low for several weeks because of increased demand “driven by broader market dynamics,” a Sanofi spokesperson told STAT. The issue is not technically considered a shortage by the Food and Drug Administration, but patients are nonetheless having trouble finding the medication.”* * *
    • “Pharmacists can try to switch patients over to Semglee or Rezvoglar, the FDA-approved biosimilars, if their insurance allows that. Or they could ask prescribers to go for Lilly’s Basaglar, which comes in pen form.”
  • Thompson Reuters tells us about
    • Rev. Proc. 2026-26 (July 21, 2026). Available at https://www.irs.gov/pub/irs-drop/rp-26-26.pdf
      • “The IRS has announced 2027 indexing adjustments for important percentages under the Affordable Care Act (ACA). The indexing adjustments are based on projections of premium growth and income growth. For 2025 and several years prior, the premium growth rate was based on per enrollee spending for employer-sponsored insurance as published in the National Health Expenditure Account. However, HHS revised the measure to also capture increases in individual market premiums, starting with the 2026 benefit year. The IRS is applying this updated premium growth measure for 2027 as well.
      • “The required contribution percentage is used to determine whether employer-sponsored health coverage is “affordable” for purposes of employer shared responsibility under Code § 4980H. It is adjusted from a 9.5% baseline to 10.22% for plan years beginning in 2027. (This is an increase from 9.96% for 2026.) The percentages used to determine the amount of household income that individuals who are eligible for premium tax credits must contribute toward the cost of Exchange coverage vary across household income bands. The 2027 percentages range from 2.15% to 10.22%.”
  • STAT News informs us,
    • “The Senate’s [HELP] panel delayed until next week a vote on Erica Schwartz to run the Centers for Disease Control and Prevention, after postponing a separate vote on Sean Kaufman for a key public health preparedness role.”
  • and
    • “Nearly 18 months after taking office, President Trump has nominated a leader for the federal agency that oversees mental health and addiction policy. 
    • “If confirmed by the Senate, Timothy Westlake, a Wisconsin-based physician with decades of experience in both clinical and policy roles, would serve as assistant secretary of mental health and substance use. The position would also make him head of the Substance Abuse and Mental Health Services Administration, which has operated without a long-term leader since Trump was inaugurated in January 2025.” 
  • Tammy Flanagan, writing in Govexec, discusses “Why your retirement experience may depend more on the agency than the benefit.”
    • “Federal retirees interact with OPM, the Thrift Savings Plan and Social Security at different stages of retirement. Their latest performance data reveals starkly different customer service experiences and highlights where delays remain most likely.”
  • OPM Director Scott Kupor added (Substack link) a post to this Secrets of OPM blog. This one concerns the vital importance of investment income to benefit programs.
    • “The federal government manages a number of trust funds, but the two largest are the Social Security Trust Fund (about $2.7 trillion today) and the Civil Service Retirement and Disability Funds (CSRDF) (about $1.1 trillion today), the latter of which we at the Office of Personnel Management (OPM) have the privilege of overseeing.”
    • “It’s unlikely we are going to get Congress to eliminate the Treasury-only investment restrictions on the Social Security Trust Fund or the CSRDF. One can dream, but we all know that hope is not a strategy. However, all hope is not lost – and we at OPM have partnered with the Treasury Department to change what we can to the benefit of the American taxpayer.
    • “Enter “duration.”
    • “A very quick lesson on the economics of treasuries (and bonds more generally). Treasuries have varying expiration dates (or “duration,” as the finance nerds prefer). For example, you can buy Treasury bills (less than 1-year in duration), Treasury notes (with 2, 3, 5, and 7-year durations) and Treasury bonds (with 20 and 30-year durations). It’s not always the case, but in general the longer the duration, the higher the interest rate the government will pay you on the bond. Today, a 30-year duration bond pays about 5% in annual interest, whereas the 10-year pays 4.5% and a 1-year pays 4%.
    • “Historically, the CSRDF has had an average duration across its entire Treasury portfolio of about 7.5 years. That means, that we had lots of different maturities, ranging from less than 1-year to up to 15-years, but the average was right in the middle. As a result, we have achieved the roughly 3-4% annualized returns that I mentioned above on the overall fund balance.”* * *
    • “Partnering with Treasury, we concluded that a longer average duration was appropriate for the CSRDF from a risk and pension liability perspective and would yield a better economic return to the fund. As a result, OPM has increased our duration from 7.5 years to 15 years by adding longer-date treasuries (e.g., 20- and 30-year bonds) to the portfolio.
    • “Who cares? Well, this enabled us to increase the expected investment return of the portfolio to approximately 4.4%.”

From the Food and Drug Administration front,

  • A Dallas Texas NBC TV station reports,
    • “The FDA announced that nearly 20 million eggs (more than 1.5 million cartons) are being recalled due to the risk of Salmonella.
    • “Midwest Poultry Services voluntarily issued the recall of white shell eggs and brown cage-free shell eggs that were sold at Kroger and Brookshire Grocery stores in Texas, as well as smaller retail outlets.
    • “The eggs are also sold in Louisiana, Oklahoma, Arkansas, New Mexico, and Mississippi.
    • “The eggs were produced and distributed in Texas between June 6 and July 3; the latest sell-by or best-by date is Aug. 17.
    • “The recalled eggs will have an identifying code number printed on the left or right sides of the carton in date-coding ink only. Only codes P-1950 or 0840962 with a Julian Date between 157 and 184 printed on the side of the carton are recalled.”
  • Fierce Pharma relates,
    • “An FDA advisory committee has recommended that two peptide drugs that were previously restricted because of potential safety concerns be restored to the 503A Bulk Drug Substances list, which would remove the restrictions on how they are produced by compounders.
    • “Eight of the 15 members of the Pharmacy Compounding Advisory Committee (PCAC) voted to add both drugs back to the list, with six members voting ‘no’ and one abstaining. 
    • “BPC-157 and KPV are the first two of seven drugs that are being reviewed Thursday and Friday by the PCAC. In 2023, 12 peptides were reclassified, which restricted their use. In addition to safety concerns, the FDA cited a lack of evidence supporting their efficacy.”
    • “BPC-157, which is not approved by the FDA, is a synthetic anti-inflammatory peptide used to treat ulcerative colitis. BPC-157 and KPV, also an anti-inflammatory,  have also gained popularity in wellness and fitness influencer circles for supposed soft-tissue healing and bone repair capabilities. 
    • “The FDA is not required to follow the recommendations of the PCAC. The agency will make the final decision on whether the peptides can be manufactured by compounders.”  
  • The Wall Street Journal informs us,
    • “The U.S. Food and Drug and Administration said Wednesday it is investigating an additional cyclospora outbreak that the agency said has sickened at least 72 people.
    • It is the latest of four continuing cyclospora outbreaks being investigated by the FDA. The largest involves at least 1,644 cases, which have been linked to shredded iceberg lettuce supplied by Taylor Farms and served at Taco Bellin five states. 
    • “The companies have said that the shredded lettuce, sourced from central Mexico, has been removed from the U.S. market. Taylor Farms said last week that it voluntarily recalled iceberg lettuce grown and processed in Mexico, including products sold in grocery stores and restaurants across 27 states in the U.S.
    • “The FDA hasn’t yet identified a source for any of the other cyclospora outbreaks.”
    • “The FDA also said it was investigating at least 106 reported cases of salmonella and eight cases of listeria. The sources of those illnesses have yet to be identified.”

No Surprises Act News

  • Modern Healthcare reports,
    • “The Centers for Medicare and Medicaid Services and its contractors can’t keep up with the ceaseless onslaught of No Surprises Act out-of-network billing cases, federal data show.
    • “Providers and health insurance plans initiated 1.43 million Independent Dispute Resolution arbitrations this year through May, 46% more than during the comparable period in 2025. The system resolved 1.36 million cases over those five months.” * * *
    • “There’s no real end in sight,” said Lawson Mansell, a senior health policy analyst at the Niskanen Center, a centrist think tank.
    • “There have been 6.3 million cases since Independent Dispute Resolution began in 2022, and arbitrators have resolved 5.9 million. Providers file the lion’s share of cases.” * * *
    • “The new gateway may reduce the backlog, Mansell said. But because providers can win large payments, they have an incentive to continue filing many cases, he said.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Health and Human Services Department will fight to restore policies it says are vital to protecting the health insurance exchanges against fraud.
    • “HHS filed an appeal with the U.S. Court of Appeals for the 4th Circuit on Tuesday to reverse a decision the U.S. District Court for the District of Maryland handed down last month that invalidated portions of a program integrity final rule the Centers for Medicare and Medicaid Services issued last year.
    • “Democratic elected officials representing Baltimore, Chicago and Columbus, Ohio, are the lead plaintiffs in the case alongside the left-leaning advocacy groups Doctors For America and the Main Street Alliance. The plaintiffs contend CMS didn’t follow proper regulatory procedure when it issued the regulation.” * * *
    • “Last week, the same district court temporarily blocked sections of a separate health insurance exchange rule in a case brought by some of the same plaintiffs.”
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services yesterday released implementation guidance following a district court ruling July 16 that enjoined eight provisions from its 2027 notice of benefit and payment parameters final rule, which were set to become effective July 20. The rule issues standards for qualified health plans offered through the health insurance marketplaces. “Accordingly, for plan year 2026, Exchanges must immediately begin to update their systems to stop removing or denying advance payments of the premium tax credit for any new applicants or existing enrollees due to having failed to file and reconcile prior years’ premium tax credits,” CMS wrote. “Exchanges must continue in this manner for plan year 2027.” The agency said that the Department of Health and Human Services reimplemented the automatic 60-day time extension to resolve inconsistencies in household income data.”

From the public health and medical / Rx research front,

  • Fox News reports,
    • “As New York City continues to investigate an outbreak of Legionnaires’ disease that has claimed multiple lives and sickened dozens of people, doctors say there are ways people can reduce the risk of exposure.
    • “As of July 21, there have been five deaths and 82 diagnoses linked to the Upper East Side outbreak, according to the New York City Department of Health and Mental Hygiene. Eight patients remain hospitalized.
    • “Health officials said no new cases had been reported in the previous six days, suggesting the source of exposure has likely been eliminated, although the investigation remains ongoing.
    • “Legionnaires’ disease is a serious type of pneumonia that is typically spread by tiny water droplets containing Legionella bacteria, according to the Centers for Disease Control and Prevention.”
  • The Wall Street Journal informs us,
    • “Many people are reconsidering their Caesar salad lunches and berry breakfasts as cases of cyclosporiasis, the explosive-diarrhea illness, continue to rise in the U.S.
    • “The good news is, they don’t have to. The Centers for Disease Control and Prevention hasn’t recommended that people cut fresh produce out of their diets, only that they avoid recalled iceberg lettuce from Taylor Farms.
    • “We asked food-safety experts what we know—and don’t—about how to safely eat produce right now.” * * *
    • The only food recalled in connection with the current cyclosporiasis outbreak is iceberg lettuce from Taylor Farms de Mexico, sourced from central Mexico. The CDC lists all of the affected products here. Of course, this list could grow so consumers should keep an eye on the latest news.
    • “The vast majority of fresh fruits and vegetables are safe to eat, food-safety experts say. All fresh produce carries some inherent risk, separate from the cyclosporiasis outbreak, but experts say the health benefits of eating these foods generally outweigh those. 
    • “It’s a special time of year,” said Kali Kniel, a professor of microbial food safety at the University of Delaware. “Go to the farmers market, buy local if you can, where you know a farmer in your area has grown that directly.”
    • “Commercial processing can magnify certain food-safety risks, including chopping and shredding in large facilities where a single contaminated leaf can mix with other produce. For salad lovers, experts recommend buying whole heads of lettuce and removing and discarding the outer couple of layers of leaves.
    • “Mixed-lettuce bags might make life easier, but they are particularly risky since the lettuce is pulled from different sources, said Marion Nestle, a professor emerita of nutrition, food studies and public health at New York University.” * * *
    • “Cooking produce to 158 degrees Fahrenheit is the surest way to eliminate risk of contamination, experts say. 
    • “Peeling, too, or removing outer layers of produce, is another effective safeguard. Cyclospora parasites often become entrapped in produce through contaminated water used to grow or wash it, so areas that come into contact with water are more likely to be affected. 
    • “Freezing might reduce some risk by eventually killing eggs of the parasite, but doesn’t guarantee safety.”
  • and
    • “Congratulations if you’re among the country’s nearly 56 million ex-smokers. Many health benefits are coming your way—some of them within just a few minutes.
    • “Over the long term, though, the health picture gets a lot more complex. Some problems caused by smoking take decades to clear up, and certain lung damage can’t be fixed. Plus, a higher risk for lung cancer never completely fades.
    • “Even so, there are plenty of steps ex-smokers can take to boost the benefits from quitting, from changing their diet to beefing up their exercise regimen. Even if restoring pristine lung condition isn’t an option, doctors say quitting still matters—both for health and quality of life.
    • “Quitting is absolutely one of the most powerful things that someone can do for their health at any stage, at any time,” says Eric Singhi, a thoracic medical oncologist with the MD Anderson Cancer Center in Houston.”
  • Cardiovascular Business tells us,
    • “Approximately 20 million routine chest CT scans are performed for non-cardiac reasons in the U.S. each year. They represent a large untapped opportunity to detect coronary artery disease.
    • “That’s according to a presentation at SCCT2026, the Society of Cardiovascular Computed Tomography (SCCT) annual meeting, by Suhny Abbara, MD, MSCCT, senior associate consultant and professor of radiology at Mayo Clinic in Jacksonville, Florida, editor-in-chief of Radiology, the flagship journal of the Radiological Society of North America (RSNA), and a former SCCT president. He urged health systems to capitalize on the incidental findings already visible on millions of imaging exams.
    • “As a cardiac CT person, I think I can make less of a difference population-wise with coronary CT,” Abbara said. “Those are patients that are already on our radar. There is a huge number of patients, 20 to 40 times more, where we can detect coronary atherosclerosis serendipitously in a CT done for other reasons.”
  • Health Day relates,
    • “Obesity treatment for young people in the U.S. is rapidly changing.
    • “Adolescents and young adults are increasingly using GLP-1 weight-loss medications, while rates of bariatric surgery are declining, according to a study published July 20 in JAMA Pediatrics.
    • “This research is the first national-scale Epic Cosmos analysis, to our knowledge, to characterize real-world use of combined GLP-1 receptor agonist therapy and metabolic and bariatric surgery among adolescents and young adults with obesity,” said lead author Sarah Messiah, associate dean for research at UT Southwestern’s Peter O’Donnell Jr. School of Public Health.
    • “Researchers analyzed records from more than 204,000 patients between 13 and 25 years of age who were treated for obesity between May 2022 and January 2026.
    • “They found exclusive GLP-1 use increased from 88.2% in 2022 to 96.1% by early 2026. During the same period, bariatric surgery rates fell from 11.6% to 3.7%.”
  • BioPharma Dive adds,
    • “Eli Lilly on Thursday bolstered the case for its new experimental obesity medicine, announcing the success of two more Phase 3 trials and plans to seek approval of the drug next year. 
    • “The Triumph-2 and Triumph-3 studies build on research released in May that found the drug, retatrutide, could help people lose 30% of their body weight after 104 weeks, reaching a level associated with bariatric surgery. The two new trials included overweight or obese patients who also had either type 2 diabetes or cardiovascular disease.
    • “The overall weight loss in the two studies was less than in the Triumph-1 study released in May, showing an average of 21% body weight loss after 80 weeks in the diabetes group and 23% loss in the cardiovascular disease cohort at the highest doses. Still, those results met expectations for patients with underlying conditions who often lose less weight, RBC Capital Markets analyst Trung Huynh wrote in a note to clients.”
  • The American Hospital Association lets us know “what doctors want patients to know about heart failure.
    • “Heart failure can affect energy, breathing and daily life, but early diagnosis, treatment and follow-up can help people manage symptoms.”
  • Fierce Pharma reports,
    • Johnson & Johnson has unveiled massive phase 3 survival data for its dual bispecific combination in earlier-line multiple myeloma, delivering another catalyst that could add a new twist in the commercial trajectories of off-the-shelf T-cell engagers versus personalized CAR-T therapies.
    • The combination of J&J’s Tecvayli and Talvey slashed the risk of disease progression or death by 89% compared to standard-of-care cocktails in second- to fifth-line multiple myeloma patients, according to results from the phase 3 MonumenTAL-6 trial. 
    • In another remarkable showing, the two T-cell engagers targeting BCMA and GPRC5D delivered a 62% reduction in the risk of death, J&J announced Thursday.

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

  • Beckers Hospital Review reports,
    • “Dallas-based Tenet Healthcare recorded an $826 million net income in the second quarter of 2026, up from $288 million during the same period, according to its July 23 financial report. 
    • “The publicly traded for-profit system reported operating income of $1.5 billion (26.7% operating margin) during the three months ended June 30, up from $823 million (15.6% margin) during the same period last year. 
    • “Total operating revenue was $5.6 billion in the second quarter of 2026, a 6.8% increase year over year. Tenet received $413 million in revenue in Q2 from the early conclusion of Conifer’s revenue-cycle services contract with Chicago-based CommonSpirit Health, bringing full control of the company back under Tenet. 
    • “Tenet’s salaries, wages and benefits totaled $2.23 billion in Q2 2026, a 3.3% increase year over year. Supply expenses totaled $984 million, a 5.6% increase. Other operating expenses totaled $1.2 billion, a 4.9% increase. 
  • and
    • “Most patients decide on a hospital before settling on a physician — or land on both in the same step — when they first encounter a new health concern, according to survey results U.S. News & World Report published July 20.
    • “U.S. News worked with PureSpectrum to poll 500 Americans nationwide who had personally arranged care for themselves or a family member within the past two years.
    • “Fifty-three percent of respondents said the hospital came first in their decision, or that hospital and physician were chosen together. The other 47% picked their physician before the hospital entered the picture.
    • “When a preferred physician cannot practice at a patient’s hospital of choice, 80% follow that physician to a different facility rather than give up the relationship. Only 20% take the opposite route, opting for a different physician to stay at the hospital they want.
    • “Patients trust referrals from physicians the most when it comes to sources of information about hospitals, averaging at 4.0 on a five-point scale of trustworthiness. Next was data directories, such as online directories or hospital websites, at 3.5 to 3.7, followed by AI chatbots, social media and podcasts, at 2.7 to 2.8.
    • “Age shifts that picture: patients between 26 and 40 place nearly as much trust in podcasts, AI chatbots and social platforms as they do in referrals or hospital websites — a gap that is far wider among older patients. That same younger group also leans on consumer reviews: 81% said sites like Google and Yelp shape what they decide.”
  • Beckers Physician Leadership points out five things to know about “the forces reshaping physician compensation in 2026.”
  • Fierce Healthcare tells us,
    • “Teladoc Health unveiled a new virtual care model for employers and health plans designed to offer a more coordinated, personalized approach for members, while tying payment to clinical and financial outcomes.
    • “The model, called Teladoc One, was built to replace fragmented, condition-specific healthcare programs with an integrated offering that dynamically supports a person’s entire health needs rather than only addressing one disease at a time, company executives said. As part of the model, Teladoc Health care teams deliver and coordinate care across virtual settings and in partnership with a member’s local providers. 
    • “Teladoc One, fundamentally, is a new care model that’s changing the way that we deliver care,” Kelly Bliss, president of U.S. Group Health at Teladoc Health, told Fierce Healthcare in an interview.”
  • and
    • “Cigna Healthcare is taking steps to significantly expand its personalized care management programs, leaning on AI to identify risks sooner and simplify the patient journey.
    • “Through the initiative, Cigna’s care teams use predictive analytics to identify individuals who may benefit from supports or intervention earlier, which can avert more negative outcomes or disease progression down the road.
    • “The insurer also deploys its more than 1,250 clinicians, including nurse managers and behavioral health professionals, to guide the care journey. They are empowered to coordinate care between providers and point members to supports available through their health plan that may be beneficial.”
  • and
    • “Erlanger Health System plans to join Prisma Health, creating a 27-hospital system in exchange for a $2 billion strategic capital commitment toward care in the Chattanooga, Tennessee area.
    • “The nonprofit health systems announced their signed non-binding letter of intent Wednesday morning but did not provide a tentative timeline for the deal. A final agreement will require approvals from Erlanger’s board of directors, who already have backed the deal, as well as Erlanger’s independent oversight monitor board, the local county commission and other state and federal regulators. 
    • “The pair said their proposed partnership will boost access to specialty care, better fund long-term capital projects, secure “mission critical programs” such as southeast Tennessee’s only Level 1 trauma center and other safety-net operations, and generally help the organization grow amid a toughening operating environment.” 
  • Beckers Health IT lets us know,
    • “OpenAI has expanded Health, a ChatGPT feature that lets users securely connect personal health data, to all eligible users in the U.S.
    • “The rollout covers logged-in users age 18 and older on web and iOS across the Free, Go, Plus and Pro plans, according to a July 23 OpenAI news release.
    • “Health lets users connect Apple Health data and supported medical records from U.S. hospital systems, One Medical or Function Health. With permission, ChatGPT can then use that information across any conversation, not just within a dedicated Health tab, to compare lab results, summarize changes since a last appointment, or factor in a recent injury or dietary restriction.
    • “OpenAI said the wider release builds on a limited early test in which more than 70% of health-related conversations happened outside the dedicated Health space, prompting the company to fold that context into everyday chats. Connected medical records and Apple Health data, along with conversations that use them, are not used to train OpenAI’s foundation models or target ads, the company said. Users can disconnect data sources at any time, and connected data is deleted from OpenAI’s systems within 30 days.
    • “The feature runs on GPT-5.5 Instant for free users and GPT-5.6 Sol for paid users, both developed with input from physicians and evaluated on OpenAI’s HealthBench Professional benchmark.” 
  • The Wall Street Journal adds,
    • “One of the looming worries about artificial intelligence is that it will automate away jobs. A report from researchers at Google released Thursday says that, so far, the technology is mainly being used as an aid to workers.
    • “It is a finding that, if it holds true as AI continues to develop, could point to a future where the demand for highly skilled workers is accentuated rather than diminished. 
    • “Just because you’re using AI doesn’t mean it’s going to automate your job,” said Google economist Scott Strand, one of the researchers.” * * *
    • “The research says that while workers in higher-paid occupations tend to use AI more, its use isn’t limited to jobs typically held by college-educated workers. People in manual and technical trades, such as electricians and auto mechanics, are using AI significantly as a hands-on collaborator, and are uploading images and videos to solve problems far more frequently than their white-collar counterparts. 
    • “The research also finds that people are turning to AI to help speed up drudge work at home, such as dealing with government paperwork, building household budgets or helping with home repairs. The gains people are getting from AI use at home are unlikely to show up in standard economic statistics.”

Midweek report

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

Simplicity is a virtue

From Washington, DC

  • Beckers Payer Issues calls attention to eight bills in Congress that payers should be following.
  • Per a Senate news release,
    • “Today the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted to favorably report multiple bills making health care more affordable and accessible to American families.” * * *
    • “The National Plan for Epilepsy Act, Expedited Access to Biosimilars Act, and Making America’s Food Safer Act passed unanimously 22-0 as amended in an en bloc vote. The Patients Deserve Price Tags Act, CLEAR LABELS Act, EMPOWER for Health Act, Title VIII Nursing Workforce Reauthorization Act of 2025, and Rural Obstetrics Readiness Act passed 21-1 as amended in an en bloc vote. The SAFE Drugs Act of 2026 passed as amended 17-5, the INSULIN Act of 2026 passed as amended 17-5, and the Childhood Diabetes Reduction Act passed as amended 12-10.”
  • Bloomberg Law reports,
    • “Legislation advanced on a bipartisan basis by the House oversight panel Wednesday aims to regulate pharmacy benefit managers contracting with health benefits for federal employees.
    • “The measure (H.R. 6610) would set standards for pharmacy reimbursement, require that drug rebates be applied to copayments and coinsurances, and prohibit PBMs from steering beneficiaries to specific pharmacies for the Federal Employees Health Benefits Program. The measure was approved 40-2.
    • “For too long, federal employees and tax payer-funded federal agencies have been held captive by a health care system manipulated at every turn by three large PBMs and their affiliate companies,” said Oversight Chair James Comer (R-Ky.).”
  • FEHBlog observation: The bill would price fix small molecule drug prescriptions. It’s not a good idea from a market place standpoint to set prices in statutes. The next step for this bill is House floor consideration, but the House will be on a District work break beginning tomorrow until August 31. So, there is time for cooler heads to prevail.
  • CBS News relates,
    • “The Trump administration is forging ahead with a controversial plan to collect the medical records of millions of federal workers and retirees, as well as their family members.
    • “The Office of Personnel Management said in a notice posted last month that it will begin routinely collecting identifiable, personal health information on more than 8 million people — despite concerns from privacy advocates and Democrats, who have demanded the agency drop the plan. The notice will go into effect July 24, allowing OPM to begin its collection at any point afterward.” * * *
    • “In its latest notice, OPM argues that the vast trove of data is necessary to ferret out fraud and overpayments in the FEHB and PSHB programs. Those programs cost roughly $80 billion a year, with about $50 billion covered by the federal government and $30 billion funded by enrollees. The Trump administration has ramped up efforts, led by Vice President JD Vance, to curtail what it says is rampant fraud and misuse of publicly funded health benefits.
    • “The effort still faces criticism that it doesn’t go far enough to protect the privacy of federal workers and their families.
    • “Clearly, this administration has not earned our trust with Americans’ sensitive data,” Sen. Mark Warner (D-Va.) said in an emailed statement to KFF Health News. “If OPM wants to work in good faith to reduce fraud, they should come to Congress, including to folks like me who are engaged on this issue and represent many federal workers and retirees and their families, and work to build consensus and trust before implementing these sweeping changes.”
  • FEHBlog observation: OPM overlooks the fact that carriers, who hold the financial risk in the FEHB and PSHB programs, already focus on preventing fraud, waste, and abuse, in cooperation with the OPM Inspector General’s office. Carriers submit annual reports on those efforts to OPM.
  • Per an OPM news release,
    • “ICYMI: OPM Director Scott Kupor Discusses Merit-Based Federal Hiring and Restoring Accountability on The Ingraham Angle.”
  • Beckers Hospital Review informs us,
    • “President Donald Trump plans to place tariffs on generic drug imports, building on the 100% tariff he imposed on patented pharmaceutical products in April. While that policy exempted generic drugs and biosimilars for the time being, the White House said it would reassess the exemption within a year. 
    • “Here are three things to know from the latest announcement, made in a July 21 Truth Social post:
      • “The tariff schedule would be rolled out over three years. Starting Aug. 1, generic drugs will continhttps://www.hhs.gov/press-room/hhs-joins-genesis-mission-ai-chronic-disease-research.htmlue entering the U.S. tariff-free for a two-year period. After that, the tariff rises to 100% for one year, then to 200% thereafter.
      • “President Trump said the schedule is meant to “reshore” generic pharmaceutical production into the U.S., calling the escalating tariffs a “penalty” for companies that do not build manufacturing plants and equipment domestically within the two-year window.
      • “President Trump said the policy on patented, branded or innovative drugs “will remain as is.” Under the April policy, those tariffs are set to take effect July 31 for large companies and Sept. 29 for smaller firms, with reduced or zero rates available to companies that reach most favored nation pricing agreements with HHS and onshoring agreements with the Commerce Department. This announcement effectively replaces the one-year review window for generics with a defined, longer timeline.”
  • The American Hospital Association News points out,
    • “The Department of Health and Human Services July 22 announced that it will participate in the Genesis Mission, an artificial intelligence initiative focusing on scientific research that originated from a November 2025 executive order. HHS will work with the Office of Science and Technology Policy to launch a series of science and technology challenges involving AI, including one focusing on identifying root causes of chronic disease and others on pediatric cancer research and drug discovery and development.
    • “In addition, OSTP July 22 released a report, “Science: A New Golden Age,” on scientific initiatives using AI. The report outlines four pillars: revitalizing America’s science and technology enterprise through recommendations such as refocusing on individual scientists and diversifying funding mechanisms; securing U.S. dominance in critical and emerging technologies through efforts such as public-private partnerships and challenges; ensuring science and technology betters the lives of all Americans through recommendations such as training and career pathways; and launching a golden age of science through efforts such as the Genesis Mission. An annex to the report, the “White House Fiscal Year 2028 Research and Development Budget Priorities Memorandum,” consists of directives for federal agencies to implement recommendations in the report.” 
  • Per Department of Health and Human Services news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced that the Centers for Medicare and Medicaid Services (CMS) sent a notification urging every State Medicaid Director to phase out the use of mercury-containing dental fillings by restricting or ending their respective state’s Medicaid coverage for dental procedure codes for “dental amalgams.” Dental amalgams are a material that combines mercury with other heavy metals to fill cavities but pose health and environmental risks.”
  • Healthcare Dive notes,
    • “The Department of Labor’s employee benefits arm proposed a rule Wednesday that would allow insurers to share mandatory group health plan disclosures with their beneficiaries electronically.
    • “Many of the communications, like summary plan descriptions, claims denials or notices that coverage can continue after a job loss, are currently sent via physical mail. But if the rule is finalized, plans will be able to post the documents online and notify a member by text or email when a disclosure is available.
    • “It’s “a big step forward in how Americans receive important information about their health benefits,” Daniel Aronowitz, who leads the DOL’s Employee Benefits Security Administration, said during a press briefing.”

From the Food and Drug Administration,

  • MedPage Today reports,
    • “The FDA approved zidesamtinib (Jideytro) for previously treated adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), drugmaker GSK announced Wednesday.
    • “Zidesamtinib is a next-generation, brain-penetrant ROS1-selective inhibitor designed to overcome ROS1 resistance mutations.
    • “Approval was based on the phase I/II ARROS-1 trial that included patients with ROS1-positive NSCLC who were previously treated with a ROS1 kinase inhibitor. In the overall population of 117 patients, the objective response rate (ORR) was 44%, with rates of duration of response at 6 and 12 months of 82% and 69%, respectively.”
  • MedTech Dive relates,
    • “Johnson & Johnson said Wednesday it received Food and Drug Administration de novo authorization for its Ottava robotic surgery system to perform multiple procedures in general surgery.
    • “The authorization brings to the U.S. market a second heavyweight challenger to Intuitive’s da Vinci robot in soft tissue procedures, following Medtronic’s FDA clearance in late 2025. A wave of smaller companies, including CMR Surgical, Distalmotion and Moon Surgical, are also launching robotic systems in the U.S., giving Intuitive its first competition in more than two decades.
    • “J&J said it will launch Ottava with select U.S. customers while working to obtain additional indications and regulatory jurisdictions over time.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The participating manufacturer intends to offer a device for use in providing care expected to be covered by the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model and intended to improve health outcomes for Americans managing certain chronic diseases.
    • “The FDA selected Dexcom, Inc., as the first participant in the TEMPO pilot. The Dexcom Glucose Health Program, which the FDA will continue to evaluate for its intended use during the pilot, is intended to address two clinical use areas in the ACCESS Model.
    • “The Dexcom Glucose Health Program is intended to enable patients aligned to the ACCESS model and their healthcare professionals or caregivers to monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights for informed decision-making and behavioral modifications. The program is intended as an aid in the screening for prediabetes and type 2 diabetes through integrated digital health metrics. It may also contribute to improving glycemic control and lowering HbA1c in people with prediabetes.”
  • and
    • “The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again. The FDA is issuing a final order revoking the authorized use of Orange B as a color additive in food and is proposing to revoke the authorized use of Citrus Red No. 2 as a color additive in food.”

No Surprises Act News

  • The Wall Street Journal reports,
    • “A controversial process for arbitrating medical billing disputes awarded nearly $15 billion in payouts to healthcare providers last year, according to new federal data analyzed by The Wall Street Journal, more than triple the total for 2024.
    • Doctor groups representing radiologists, anesthesiologists and emergency-room physicians have been among the winners under the setup, which was created under a 2020 law meant to protect patients from surprise medical bills. Insurers have to make the awarded payouts, and they have generally ended up on the losing end since arbitration began four years ago.
    • “For 2025, total payouts under the arbitration process reached $14.85 billion, according to a Journal analysis of new, previously unreleased data from the Centers for Medicare and Medicaid Services. The figure for 2024 was $4.08 billion, according to the analysis.
    • ““It’s shocking that it’s rising so fast,” said Jack Hoadley, a research professor emeritus at Georgetown University’s Center on Health Insurance Reforms.”
  • FEHBlog observation: It is indeed a big bowl of wrong.

From the judicial front,

  • Fierce Healthcare reports,
    • “The Trump administration will appeal a Georgia court ruling that triggered a broad recalculation of insurers’ Medicare Advantage star rating scores for 2026.
    • “In court documents filed Tuesday, federal agencies said they would appeal the ruling to the Eleventh Circuit Court of Appeals. In late May, a judge in Georgia’s Southern District Court came down in favor of Clover Health, tossing 20 measures that the Centers for Medicare & Medicaid Services used to calculate its scores.
    • “The court cut 10 of those measures, as the judge determined CMS exceeded its statutory authority in the data sources used, while the remaining 10 were rejected because the court ruled CMS did not meet its rulemaking and comment requirements to use them.”
    • “The ruling also triggered several follow-up lawsuits from other payers over the calculations, including Elevance Health, Alignment Healthcare and SCAN Health Plan.”
  • Per a Department of Justice news release,
    • “A federal jury in the Southern District of Florida convicted a Florida licensed pharmacist and pharmacy owner yesterday for her role in dispensing over 300,000 oxycodone 30mg pills to pharmacy patrons who had no medical need for the drug.
    • “According to court documents and evidence presented at trial, Olushola Yusuf, 60, of Tampa, dispensed oxycodone to nearly all her pharmacy customers. Yusuf charged customers approximately 10 times the typical cost of the drug and required payment from them in cash. In total, Yusuf dispensed at least 335,351 pills of oxycodone 30mg during the conspiracy. Oxycodone 30mg is the maximum strength available of the drug and is both sought after and potentially dangerous due to its potency. It is typically prescribed to seriously ill patients, such as those suffering from chronic cancer pain or traumatic injuries.”

From the public health and medical / Rx research front,

  • Beckers Clincal Leadership informs us,
    • “In the nation’s largest outbreak of cyclosporiasis, the CDC has reported 4,940 lab-confirmed and 341 hospitalizations across 41 states, according to a July 21 update. 
    • “Between May 1 and July 20, the federal health agency reported 4,173 domestic cases and 767 illnesses acquired outside the U.S. A majority of hospitalizations, 308, are also domestically linked.
    • “In 2025, the U.S. recorded 3,955 cyclosporiasis cases, meaning the number of illnesses over the past 11 weeks have exceeded last year’s total, according to the Washington Post. 
    • “The FDA and CDC’s traceback investigations have “converged” on now-recalled iceberg lettuce grown in Mexico by Taylor Farms, one of the largest fresh-produce suppliers for the U.S. Despite a false positive test, federal officials seem to have traced a significant portion of the outbreak to Taylor Farms. 
    • “Normally, cyclosporiasis cases annually peak between May 1 and Aug. 31. This year, a spike of illnesses had a June 26 onset date, according to the CDC. Michigan and surrounding states appear to be hardest-hit, with Michigan officials reporting 6,571 cases and 102 hospitalizations as of July 21, and Ohio logging 1,246 confirmed cases as of July 16.” 
  • The Washington Post reports,
    • “The United States has now reported the most measles cases in any year since 1991, not only surpassing all of last year’s record total, but also reaching the highest level in 35 years, with more than five months still remaining in 2026.
    • “The country reported 2,295 cases as of Tuesday, according to data from Johns Hopkins University’s U.S. measles tracker. The total surpasses last year’s 2,289 cases and is the highest annual count since the highly contagious disease was eliminated in the United States in 2000.
    • “The fact that we’ve reached this total this early in the year is really a reflection of those large outbreaks earlier in the year, particularly in South Carolina and Utah,” said William Moss, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. “It’s very frustrating. This is a reflection that we have been unable to stop measles virus transmission in this country.” * * *
    • “The latest milestone underscores how the country has entered a new phase in its battle with measles, with repeated new infections of the deadly disease igniting sustained outbreaks in multiple states rather than staying concentrated in a few undervaccinated communities.”
  • The American Medical Association lets us know “6 things patients should know about red light therapy.”
    • Does red light therapy really work for wrinkles, hair growth and to boost skin health? The latest “Health vs. Hype” episode explores the facts.
  • The Wall Street Journal points out,
    • “Architect Lloyd Alter states dangerous bathroom designs cause falls, the leading injury-related death for adults aged 65 and older.
    • “Freestanding bathtubs and shower-tubs are dangerous due to slippery surfaces, thin edges and a lack of grab bars.
    • “Toilets also present fall risks due to straining and high “comfort height” designs; grab bars and lower toilets are recommended solutions.”
  • STAT News relates,
    • “Europeans can now receive a device that can partially restore their vision loss. Americans may not have to wait long to get it, either.
    • “Science Corporation announced Wednesday that European regulators had approved the commercial sale of the startup’s retinal implant that improves eyesight for patients with age-related macular degeneration in their central vision, enough to read books and road signs more clearly. 
    • “We have a cochlear implant for vision now,” said Science founder and CEO Max Hodak.
    • “The implant, called PRIMA, also received a Humanitarian Use Device designation from the FDA in March, which puts the device on track to debut in the United States early next year if it receives agency approval. If it hits this milestone, PRIMA would be the second brain-computer interface (BCI) to enter the U.S. market.” * * *
    • “The Science device’s impact could be substantial. Geographic atrophy accounts for 20% of all legal blindness due to age-related macular degeneration and affects more than 1 million people in the U.S. PRIMA received FDA’s special designation because Science intends to initially use it for only the most severe cases of atrophy, which affects fewer than 8,000 people per year.” 
       
  • MedPage Today notes,
    • “Five adverse pregnancy outcomes were independently associated with increased peripheral artery disease (PAD) risk later on.
    • “These associations remained in co-sibling analyses, suggesting that familial factors are not to blame.
    • “Women with adverse pregnancy outcomes should have lifelong clinical follow up.”
  • Per Health Day,
    • “Cognitive function, manual dexterity, and breathing ability all play an important role in helping people with chronic obstructive pulmonary disease (COPD) use their inhalers correctly, according to a study published online May 27 in the Annals of the American Thoracic Society.”
  • Per BioPharma Dive,
    • “A genetic medicine from Arrowhead Pharmaceuticals has succeeded in two late-stage clinical trials focused on a condition that increases the risk of sudden, potentially life-threatening cases of pancreas swelling.
    • “The medicine, known as plozasiran, is a small piece of synthetic RNA designed to lower fat levels in the bloodstream. It does this by degrading the instructions cells use to create a protein that slows down triglyceride metabolism. Plozasiran is already approved, and sold under the brand name Redemplo, as a treatment for a rare disease that leads to extremely high levels of triglycerides. Arrowhead, though, is trying to expand the drug’s use.
    • “Positive results released Wednesday should help in that mission. Across the two trials, which enrolled adults with “severe hypertriglyceridemia,” an under-the-skin injection of Arrowhead’s drug once every three months respectively cut median triglyceride levels by 79% and 81% after one year. The reduction seen in placebo-treated patients, meanwhile, was around 27%.”

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

  • Beckers Payer Issues reports,
    • “Molina Healthcare reported $60 million in net income for the second quarter of 2026, a 76% year-over-year drop from $255 million.
    • “The insurer attributed the decline mainly to lower premium revenue and a higher medical loss ratio. Total revenue for the quarter was nearly $10.9 billion, down 4.8% year-over-year. 
    • “Even with the profit decline, Molina raised its full year 2026 adjusted earnings guidance to at least $5.25 per diluted share, up from at least $5, and lifted its GAAP guidance to at least $2.15 per share. The company said a $1.50 per share improvement in its Medicare business was offset by an equal decline in its ACA marketplace business, and that without the marketplace reduction, full year adjusted guidance would have risen to $6.75 per share.
    • “Molina’s MLR in Q2 was 92.2%, up from 90.4% in the second quarter of 2025. The company had approximately 4.9 million members as of June 30, down from 5.7 million a year earlier. Marketplace membership fell to 283,000, from 655,000 at the end of 2025 and 690,000 a year ago. The company tied the decrease to its pricing and product strategy, the expiration of enhanced ACA subsidies and new program integrity measures.”
  • Fierce Healthcare relates,
    • “Community Health Systems fell short of the market’s earnings and revenue expectations during its second quarter, posting a loss when excluding funds received for its recent hospital divestitures. 
    • “The for-profit reported Wednesday after market close net operating revenues of $2.83 billion. Net income attributable to stockholders was $70 million, or 50 cents per diluted share, but fell to a 19 cents per diluted share loss after excluding the facility sales and other adjusting items.
    • “The reported revenue and adjusted earnings are about $70 million and nine cents per share behind analysts’ estimates, per Seeking Alpha.
    • “The latter also outpaces the five cents per share net loss the system had logged for the same period last year, despite a same-store net operating revenue increase of 2.4% and same-store admissions and adjusted admissions gains of 1.9% and 2.9%. 
    • “The company primarily attributed the year-over-year performance decrease to “an unfavorable change in payor mix and higher medical specialist fees.” These were offset by improved volumes, higher reimbursement rates, greater net benefit from supplemental reimbursement programs and tighter contract labor and professional liability expenses, according to the release.”
  • and
    • “Visana Health, a virtual women’s health provider, has redesigned its annual visit to be more comprehensive and personalized.
    • “Visana’s Complete Women’s Health Visit combines preventive care, symptom evaluation and expertise across gynecology, primary care and endocrinology to tailor care to each patient. The telehealth visits are 45 minutes long and go beyond a pap smear and mammogram to include hormonal, metabolic, cardiovascular, reproductive, sexual and emotional wellbeing assessments. 
    • “It’s really a tailored visit to the individual and then optimized for what her risks are and what her questions are,” Barbara Levy, M.D., chief medical officer at Visana, told Fierce Healthcare.”
  • Beckers Hospital Review tells us,
    • “Seven hundred rural hospitals across the U.S., or about one-third of all rural facilities in the country, are at risk of closing due to severe financial challenges, according to a July 21 Center for Healthcare Quality and Payment Reform analysis.
    • “The analysis comprises 264 hospitals that are at immediate risk of closure, according to the report. In almost every state, rural hospitals are at risk of closure. In most states, more than 25% of rural hospitals are at risk and in 11 states, 50% or more are at risk.
    • “The latest data is a slight decrease from CHQPR’s May analysis, which found 720 hospitals were at risk of closure with 294 at immediate risk. 
    • “More than 100 rural U.S. hospitals have closed in the past decade, with 110 closing since 2015, according to the report. Fifty-three hospitals have ended inpatient services since the beginning of 2023 to qualify for federal grants only available to rural emergency hospitals.”
  • The Cotiviti consulting firm discusses fraud, waste and abuse in behavioral health care.
    • “Behavioral health continues to be shaped by expanding access, evolving care delivery models, and regulatory change. While these advancements have improved patient access to critical services, they have also introduced new complexities for payers working to maintain program integrity and reduce fraud, waste and abuse (FWA) risks.
    • “For health plans, particularly those serving Medicaid and other government-sponsored populations, identifying emerging billing patterns, strengthening review processes, and aligning internal teams around consistent standards can help reduce financial leakage while supporting appropriate care delivery.”
  • Beckers Hospital Review points out,
    • “GLP-1 medications are linked to a 17.3% drop in long-term sickness leave over four years, according to a working paper published in July by the National Bureau of Economic Research.
    • “Researchers compared 7,011 patients who started Ozempic during the drug’s first 17 months of availability to a matched group of 7,011 patients who initiated treatment four years later.”
  • and
    • “Where the GLP-1 compounding fight stands: 5 things to know.”
  • Per Fierce Healthcare.
    • “Samsung rolled out a beta version of its artificial intelligence-powered personal health assistant on Tuesday.
    • “The new AI assistant—dubbed Samsung Health Assistant—is embedded into the Samsung Health app and is currently available to eligible users across the U.S. It allows users to ask health questions and receive personalized guidance and recommendations through its “unique knowledge base.” Insights have been validated by a team of physicians and certified health coaches, executives say.
    • “Our new Health Assistant advances Samsung’s vision for Connected Care by giving users a deeper understanding of their mind and body through daily health monitoring and increasing opportunities for early detection,” said Hon Pak, M.D., senior vice president and head of the digital health team at Samsung Electronics, in a statement.”

Noteworthy Event

  • The Washington Post reports,
    • “An Australian woman gave birth to identical quadruplet girls last week, all from one fertilized egg that split into four.
    • “The chance of conceiving monozygotic quadruplets is 1 in 15 million, said Alexa Bendall, a maternal fetal specialist, in an interview released by Royal Brisbane and Women’s Hospital in Queensland. 
    • “The girls are named Emily, Harriet, Catherine and Alexa — in the doctor’s honor. 
    • Triplet and quadruplet pregnancies are high risk for complications for the mother and children throughout gestation, compared with twins, according to scientific research by Cambridge University Press.
    • “From an academic perspective, it’s really interesting,” Bendall said. “From a human perspective, to be able to be part of the family’s journey and come out with four beautiful babies and a healthy mum is very precious.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • The Washington Post tells us,
    • “The House passed a stopgap bill to fund the government into December in an effort to avoid another government shutdown weeks before the midterms, but the effort faces an uphill climb in the Senate.
    • “The resolution, which would fund the government through Dec. 4, passed 220-205. 
    • “House Speaker Mike Johnson (R-Louisiana) pushed the measure to preempt a showdown with Democrats in the fall over government funding as lawmakers are unlikely to meet a Sept. 30 deadline ahead of the new fiscal year.” * * *
    • “Senate Majority Leader John Thune (R-South Dakota) said he’ll bring a bipartisan agreement to fund the government to the floor before the August break. That measure would then need to be approved by the House when lawmakers return at the end of August before it goes to Trump’s desk.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) today deferred more than $1 billion in federal Medicaid payments to California and Minnesota as the states submit additional documentation supporting certain high-risk Medicaid claims. The action advances the Trump administration’s effort to combat fraud, waste, and abuse in Medicaid and safeguard federal taxpayer dollars.” * * *
    • “CMS is deferring approximately $867.5 million in federal Medicaid payments to California and $199 million to Minnesota after focused financial reviews identified claims that require additional review before federal matching funds are released. These are payment deferrals (not permanent funding cuts) and both states will have the opportunity to provide documentation showing the claims meet federal Medicaid requirements.
    • “Additionally, under Secretary Kennedy’s direction, HHS and the HHS Office of Inspector General continue to exercise exclusion authorities as a critical tool to remove bad actors from Medicare and Medicaid programs — and, in many cases, permanently bar them from returning.”
  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services today released a proposed rule that would update Medicaid provider tax policies included in the July 2025 reconciliation law and change how the agency determines whether certain healthcare taxes comply with federal requirements. States commonly use provider taxes to help finance Medicaid. CMS said the proposed changes are intended to ensure those taxes are not structured in a way that effectively guarantees providers receive their tax payments back. 
    • “The proposal would replace the current 6% indirect hold harmless threshold with state- and provider class-specific thresholds based on taxes enacted and imposed as of July 4, 2025, and would implement a phased reduction in allowable thresholds for Medicaid expansion states beginning in fiscal year 2028. The rule proposes revised interpretations of “enacted” and “imposed” taxes as described in CMS’ preliminary guidance issued Nov.14, 2025. CMS also proposes to sunset the current alternative “75/75” compliance test and establish a new provider tax class, “Services of Health Insurers,” bringing existing state taxes on health insurers under CMS oversight. 
    • “Comments are due 60 days after publication in the Federal Register.” 
  • Govexec relates,
    • “The Office of Personnel Management is set to propose new rules this week implementing a 2022 law aimed at reforming retirement benefits for federal first responders who are injured during their service and forced to pursue jobs elsewhere in government.
    • “Federal workers in professions like law enforcement and firefighting participate in the federal government’s defined benefit retirement program on an accelerated basis—in exchange for paying more toward their pensions each paycheck, they become eligible for their full annuity once they have served 20 years and reached age 50. They are also subject to mandatory retirement at age 57.
    • “But if a federal first responder is injured on the job and unable to continue in their current role, they lose access to the accelerated retirement timeline, despite the increased payments they have already made along the way.
    • “A proposed rule set for publication Wednesday in the Federal Register would implement the First Responder Fair RETIRE Act, a 2022 law aimed at fixing this flaw. The legislation allows first responders forced to take a job elsewhere in the federal government to continue to pay accelerated contributions and reach retirement when they originally planned. And it grants feds the chance to be refunded the extra half-percentage point of their salary that went toward retirement if they leave federal service altogether prior to reaching retirement age.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA added eight new members to an advisory committee slated to review whether pharmacies can legally market peptides, after criticism the panel is stacked with those tied to peptide-related businesses and clinics.
    • “The panelists were added as temporary voting members to the Pharmacy Compounding Advisory Committee, which is scheduled to convene Thursday and Friday to evaluate whether seven unapproved peptides can be reclassified to allow pharmacies to legally manufacture them. The committee will consider whether to reverse a 2023 Biden-era decision that nearly 20 peptides pose safety risks and can no longer be legally compounded.
    • “The temporary members include clinical researchers, professors of medicine, and pain and substance use experts.
    • “They seem considerably more qualified and less conflicted than the others who were added recently,” Peter Lurie, a former FDA associate commissioner, now the president of the Center for Science in the Public Interest, said in an email. “The new members are mostly confined to certain peptides, not the case for the earlier nominees.”
  • MedTech Dive relates,
    • “Philips received 510(k) clearance for a new version of its pulse oximeter clip sensor that the company says is accurate across a broad range of skin tones. 
    • “The reusable clip sensor has optical refinements to improve signal quality and measurement consistency and support reliable oxygen saturation measurements across diverse patient populations and clinical conditions, the company said in the Tuesday announcement. 
    • “Medtech firms have sought to update their pulse oximetry technology after several studies raised concerns about the devices being less accurate for people with dark skin pigmentation. The Food and Drug Administration issued updated testing recommendations for pulse oximeters in a 2025 draft guidance, but has not finalized it.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The U.S. District Court for the District of Columbia July 21 upheld a lower court’s decision that Section 340B of the Public Health Service Act does not permit drug companies to impose proposed rebate models on 340B purchasers unless the Secretary of the Department of Health and Human Services approves. The court did not weigh in on the lawfulness of the department’s proposed rebate program or any other version of a rebate model that it could approve.  
    • “The manufacturers’ reading would also counterintuitively let manufacturers, rather than the Secretary, take the lead in administering the 340B Program, rendering the Secretary’s role largely reactive,” the court explained. “Put simply, the statute places the Secretary, not the manufacturers, in the driver’s seat of this important program.” 
  • FEHBlog observation: By upholding a lower court’s decision, the article is referring to an initial decision by a Magistrate Judge.
  • BioPharma Dive relates,
    • “Novo Nordisk is suing its biggest obesity drug rival, alleging on Tuesday that Eli Lilly is engaging in deceptive advertising by intentionally using outdated studies to compare the higher doses of its medicines to lower doses of Novo’s products.
    • “Filed in a New Jersey [U.S.] District Court, the lawsuit follows a cease-and-desist order in which Novo asked Lilly to take down the advertisements. Lilly hasn’t, so the Danish drugmaker is seeking a permanent injunction to get the ads pulled and for Lilly to “conduct a corrective advertising campaign.” Lilly countered in a statement that the advertising is “truthful, it is transparent, and it is grounded in the most direct scientific evidence available.”
    • “The lawsuit comes as Lilly has gotten the upper hand in a high-stakes battle for market share. Lilly’s medicine, Zepbound, recorded $4 billion in sales in the first quarter of 2026 compared with the 18.2 billion krone, or $2.7 billion, generated by Novo’s Wegovy. The turf war escalated this year with both companies launching obesity pills that could extend the reach of weight-loss medicines.”
  • Per a Department of Justice news release,
    • “A foreign national was arrested yesterday on criminal charges related to his orchestration of a scheme to defraud Medicare over half a billion dollars for unnecessary genetic testing.
    • “Khalid Satary, 54, was charged by indictment in 2019 in the Eastern District of Louisiana as part of one of the largest health care fraud schemes ever charged by the Department of Justice. According to the indictment and court documents, from 2016 to 2019, Satary owned and operated several diagnostic testing laboratories throughout the United States that billed Medicare for expensive and medically unnecessary genetic tests. Satary allegedly conspired with dozens of patient recruiters, telemarketing call centers, and telemedicine companies to utilize deceptive marketing campaigns and illegal kickbacks and bribes to generate cancer genetic test samples that reimbursed between $10,000 to $20,000 per sample. Through his laboratories, Satary billed Medicare for over $547 million. He also allegedly paid millions of dollars in illegal kickbacks and bribes to doctors and patient recruiters. In connection with the indictment, the government seized 16 bank accounts and restrained real estate from Satary.”

From the public health and medical / Rx research front,

  • Phrma reports,
    • “A new study published in The Lancet offers some of the strongest real-world evidence to date that vaccination against human papillomavirus (HPV) is saving lives.” * * *
    • “Researchers say these findings indicate that eliminating cervical cancer is now an achievable goal. But that progress depends on maintaining timely and high vaccination rates with policies that support coverage and access to vaccines.
    • “The new findings, drawing on population-level disease surveillance, show that HPV vaccination is changing what is possible in cancer prevention.
    • “Policymakers should support policies that preserve access and help ensure families can get recommended vaccines without unnecessary barriers.”
  • Medscape adds,
    • More than 80% of patients with early Alzheimer’s disease (AD) treated with lecanemab (Leqembi, Eisai/Biogen) in routine practice remained clinically stable or improved over an average of 17 months of treatment, an interim analysis of the real-world LEADER study showed.
    • The real-world safety profile of the antiamyloid therapy was consistent with the drug’s US prescribing information, with most amyloid-related imaging abnormalities (ARIA) being asymptomatic and mild.
  • The AP relates,
    • “Road deaths are declining in the U.S. and worldwide, but lower-income countries aren’t experiencing much of the improvement, according to a study published Monday.
    • “Global rates of road injuries and deaths each fell more than 30% between 1990 and 2023, according to the study published in Lancet Public Health, which noted the progress varied from country to country.
    • “Pedestrian and vehicle occupant deaths rose over that time in six countries — including the United States. However, more recent data shows road deaths fell in the U.S. in 2024 and 2025.”
  • The New York Times tells us,
    • “Diet is one of the most important factors shaping health, but it’s surprisingly difficult for researchers to figure out what people eat.
    • “Researchers’ usual tools, like food frequency questionnaires or asking people to recall what they ate the day before, are tedious and expensive, said Christopher Gardner, a nutrition scientist at Stanford. Such efforts depend on people being candid and accurate; people forget about 15 to 20 percent of what they ate after a few days.
    • “It’s one of the reasons that nutrition research is so difficult and why the best evidence comes from small metabolic chamber studies, Dr. Gardner said. In such studies, researchers essentially “incarcerate someone,” he added. “They can’t leave. You cook the food for them, you slide it under the door, you know if they didn’t finish it.”
    • ‘But a new study, published today in the Proceedings of the National Academy of Sciences, points to a treasure trove of nutrition data: sewage. Using wastewater in North Carolina, researchers searched for traces of food DNA that had survived digestion. For less than a penny a person, they identified hundreds of foods that had been consumed — like chocolate, lettuce, turkey, blueberries, black pepper — and could even infer the socioeconomic profile of a community.”
  • The Wall Street Journal informs us,
    • “When Molly Taylor started taking Mounjaro in the fall of 2024, she marveled at the speed of results. She wasn’t overweight, but she hadn’t been comfortable in her body. Now, she could eat whatever she wanted, just in smaller portions, and people were complimenting her looks. She no longer felt self-conscious. 
    • “Then her mindset began to shift. 
    • “I gradually started to worry about what I was eating, how many calories were in it, if it was going to stop me from losing more weight,” said the 23-year-old nanny, who is studying to be a nurse in London. “I think that’s when I was starting to develop anorexia.” 
    • “GLP-1s have been hailed as miracle drugs, their rise leading to critical breakthroughs in America’s fight against obesity. Roughly 13 million Americans are now on them, according to research from JPMorgan published in February. The drugs mimic naturally occurring hormones to suppress appetite and cravings and make people feel full. For those who’ve struggled with restrictive eating and anorexia, that can be a tantalizing proposition—and a dangerous one. 
    • “Anorexia kills a higher percentage of patients than any other eating disorder, and it is the second most deadly mental illness after opioid addiction, according to data compiled by the nonprofit National Association of Anorexia Nervosa and Associated Disorders.”
  • Cigna Healthcare, writing in LinkedIn, points out,
    • “Mental health challenges rarely arrive as a single, dramatic moment. More often, they accumulate quietly—sleep gets lighter, patience gets shorter, motivation slips, and everyday tasks start to take more effort than they used to. People may still be showing up and getting things done, but with less ease, less connection, and lower reserves.
    • “Telehealth and evidence-based mental health apps can make care easier to access and easier to stick with. When support fits more naturally into real life, people are more likely to seek help sooner. That often shows up at work as steadier attention, clearer communication, more consistent follow-through, and fewer days of simply pushing through.” * * *
    • “Telehealth and mental health apps won’t solve every problem, but they can make it easier to get help sooner and stay with it. For many common needs, the evidence suggests remote therapy can be as effective as in-person care, and structured digital programs can reinforce skills between sessions. In practice, that can make day-to-day life feel more manageable.”
  • MedPage Today offers us “The Roadmap to DSM-6 — A look at conflicts of interest in the formation of psychiatry’s playbook.”
  • Health Day notes,
    • “Snoring at night might not just disrupt a partner or pets; it could also impact memory function and dementia risk.
    • “A new study in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Associationexamined the link between obstructive sleep apnea (OSA), memory and dementia risk. Researchers used cognition testing on adults aged 40 to 77 to compare people with and without the sleep disorder.
    • “Those with untreated OSA had worse cognition and memory function. They also had an increased dementia risk. 
    • “If the sleep apnea was treated, however, that changed. Adults who managed their apnea had brain testing results on par with adults without it.”
  • Per Radiology Business,
    • “A significant number of incidental breast masses are overlooked on CT scans of the chest, which could potentially lead to delays in diagnosis and treatment, researchers caution. 
    • “A new Academic Radiology analysis of incidentally detected cancers suggests that up to two-thirds of visible breast masses on emergency chest CTs go unnoticed by readers. At once center, such misses resulted in significant delays in cancer diagnosis, up to 33 months in some cases.  
    • “Although emergency chest CT scans are usually completed for other clinical indications, experts involved in the study say they present an opportunity to catch cancer earlier. However, visible lesions on these scans often are overlooked. 
    • “In recent years, especially with the COVID-19 pandemic, a significant increase in CT use in emergency departments has been observed,” Olgun Sahin, MD, with the Department of Radiology, Izmir City Hospital in Turkey, and colleagues explained. “The increasing number of chest CT scans is assumed to lead to a corresponding increase in the detection of incidental breast cancers. However, despite this increased detection potential, published data on clinical practice is striking. A retrospective study by Park et al. revealed that 64.3% of incidental breast cancers were missed in initial chest CT reporting. Similarly, Abougazia et al. recently reported 67.9% of such cases.” 
  • Per Fierce Pharma,
    • “Detailed phase 3 results suggest the two-drug combination of Gilead Sciences’ lenacapavir and Merck & Co.’s islatravir has what it takes to become the first complete weekly pill for the treatment of HIV.
    • “Two Islend clinical trials confirmed that a once-weekly, single-tablet combination of islatravir and lenacapavir (ISL/LEN) matches daily treatments like Gilead’s Biktarvy at maintaining HIV viral suppression, according to data slated for presentation at the 26th International AIDS Conference in Rio de Janeiro, Brazil. 
    • “Positioned to become the first complete weekly oral HIV treatment, ISL/LEN combines a major scientific leap with the promise of meeting diverse patient needs, Jared Baeten, M.D., Ph.D., Gilead’s clinical development lead in virology, said in an interview with Fierce Pharma.”
  • Per BioPharma Dive,
    • “Agios Pharmaceuticals has decided not to further develop one of its more closely watched medicines as a treatment for sickle cell disease due to disappointing results from a mid-stage clinical trial.
    • “The drug, called tebapivat, “did not demonstrate the level of differentiation required to support continued development,” Agios said in a statement. Tebapivat has been billed as a “next-generation” version of another Agios medicine, mitapivat, which is already approved for use in two blood disorders. These drugs work by activating the “pyruvate kinase” enzyme that’s essential for the health and survival of red blood cells.”

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

  • Modern Healthcare reports,
    • “Hospital systems are improving care transitions to help offset an expected decline of post-acute providers. 
    • “Systems are preparing for fewer post-acute referral partners, which could increase their costs, reduce revenue and slow patients’ recovery after a hospital stay. Home health, skilled-nursing, rehabilitation and hospice facilities are the focus of a sweeping fraud crackdown that has stripped some post-acute providers of their Medicare eligibility. Also, in May, the Centers for Medicare and Medicaid Services announced a six-month moratorium on new Medicare enrollment of hospices and home health agencies.
    • “The increased oversight threatens to exacerbate persistent inpatient discharge delays that are limiting access to care. Hospital systems have not experienced additional care transition hurdles yet, and executives hope expanding workforce strategies and new technology will blunt any impact.”
  • Fierce Healthcare relates,
    • “Nonprofit health systems AdventHealth and Intermountain Health announced plans Tuesday to bring Denver-area hospitals and ambulatory sites under a new, to-be-formed joint venture. 
    • “The pair have signed a letter of intent and expect to have a definitive agreement in hand “in the coming weeks” as they pursue an early 2027 close. 
    • “The proposed entity would comprise eight hospitals—five from AdventHealth and three from Intermountain—as well as “dozens” of their affiliated medical practices, clinics, urgent care and emergency centers. These represent the entirety of AdventHealth’s presence in the area, and all but one of Intermountain’s local hospitals (Intermountain Health Saint Joseph Hospital, in Denver, being the exception).”
  • and 
    • “Cardinal Health is pursuing two tuck-in acquisitions to expand its home care business.
    • “The pharmaceuticals and specialty products distributor announced on Monday it had agreed to buy AdaptHealth Corp’s diabetes health business unit and medical supply provider Strive Medical in separate deals worth $360 million.
    • “The deals will accelerate Cardinal Health’s at-home solutions’ growth strategy, the company said.”
  • and
    • “Amazon Pharmacy is collaborating with digital prescription platform eNAvvi to provide clinicians with real-time medication information and delivery options through its e-prescribing workflow.
    • “The partnership allows providers to see current pricing and stock for prescriptions, including cash pricing versus estimated insurance copays, and shows how quickly medications will reach patients, the companies said. The goal of the partnership is to support medication adherence and increase access for patients, especially for those in “pharmacy deserts.”
    • “eNavvi CEO Simon Chang said in a statement the collaboration “fundamentally changes what physicians can see and do at the moment of prescribing.”” 
  • The Wall Street Journal tells us,
    • “[The Swiss drug maker] Novartis returned to sales growth in the second quarter, reporting net sales of $14.41 billion.
    • “Core operating profit for Novartis was flat at $5.94 billion, beating analyst expectations of $5.31 billion.
    • “Novartis expects core operating profit to decline by a low single-digit percentage this year as it faces the worst patent cliff in its history.”
  • Healthcare Dive informs us,
    • “As employers grapple with worker demand for GLP-1 drugs for weight loss, 1 in 5 employers recommend employees use their FSA, HSA or integrated HRA to acquire them, according to new research from the International Foundation of Employee Benefit Plans.
    • “While most employers don’t cover GLP-1s for weight loss, many try to support workers in other ways, said Carey Wooton, associate vice president of education at the International Foundation; nearly three-quarters provide disease management and case management, more than 6 in 10 offer nutritional counseling, and a similar share cover bariatric surgery.
    • “Cost remains a major impediment to coverage. GLP-1s for weight loss represented 11.4% of annual claims for corporations in 2025, up from 6.9% in 2023, the report found.”
  • Alan Fein, writing in his Drug Channels blog, discusses “2025 Gross-to-Net Realities at Eight Top Drugmakers: The Net Pricing Drug Channel Emerges.”
  • MedTech Dive lets us know,
    • “Medtronic on Tuesday said it has developed an application for its Hugo surgical robot that enables the use of artificial intelligence to support decision-making during procedures.
    • “The Touch Surgery Aide platform incorporates Nvidia’s computing infrastructure and runs Medtronic’s AI application, called Instrument Exit Point, or IEP. The application has received Food and Drug Administration clearance, Medtronic said.
    • “Medtronic will offer an early look at the new platform this week at the Society of Robotic Surgery meeting in Florida.”

Monday update

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

From Washington, DC

  • House Majority Leader Stephen Scalise lets us know,
    • On Tuesday, [July 21] the House will meet at 10:00 a.m. for morning hour and noon for legislative business. First votes expected: 1:30 p.m. Last votes expected: 8:30 p.m. * * *
    • Legislation Considered Pursuant to a Rule:
    • Begin Consideration of H.R. 8800 – National Defense Authorization Act for Fiscal Year 2027 (Sponsored by Rep. Rogers (AL) / Armed Services Committee)
    • H.R. 6955 – Main Street Capital Access Act (Sponsored by Rep. Hill / Financial Services Committee)
    • H.R. 9770 – Continuing Appropriations Act, 2027 (Sponsored by Rep. Cole / Appropriations Committee)
  • Beckers Hospital Review reports,
    • “TrumpRx, the federal direct-to-consumer drug discount website President Donald Trump launched Feb. 5, reaches its six-month mark Aug. 5. The site has grown from 40 branded drugs at launch to 92 in July, with more than 600 generics added in May. But that catalog still covers fewer than 12% of the more than 800 brand-name drugs made by the 17 manufacturers that signed most-favored-nation pricing deals with the administration, according to an NPR analysis of an FDA drug database published July 16.” * * *
    • “Health policy researchers told NPR that TrumpRx is most useful for uninsured and underinsured cash-paying patients, particularly those seeking fertility treatment or obesity medications that insurance frequently excludes. That is not the majority of prescription drug users. Insured patients are often better off checking their copay first, a caveat TrumpRx displays on the site.”
  • Beckers Payer Issues adds,
    • “Basing Medicaid drug prices on what other wealthy countries pay could save 47 states and the District of Columbia a combined $8.6 billion — about 35% of net spending on the drugs studied — according to research published July 15 in JAMA.
    • “The analysis, led by Thomas Hwang, MD, of Boston-based Brigham and Women’s Hospital, modeled the CMS Generating Cost Reductions for US Medicaid, or GENEROUS, model
    • “Under most-favored-nation pricing, drugmakers give participating state Medicaid programs added rebates whenever Medicaid’s net price surpasses the price paid abroad. 
    • “CMS announced the voluntary model in November 2025 and launched it in January. It will run five years, and 17 pharmaceutical companies had agreed to participate, as of May, in exchange for protection from pharmaceutical tariffs.”
  • Per a Government Accountability Office news release,
    • “The Office of Personnel Management has undergone significant workforce changes in the last 2 years.
    • “Between December 2024 and March 2026:
      • OPM’s staff decreased by 35%
      • The agency eliminated 10 offices
      • 57% of employees who left OPM had 11 or more years of service—representing a loss of institutional knowledge
    • “These changes risk worsening pre-existing skills gaps we previously recommended OPM address. In addition, the OPM Office of the Inspector General identified the agency’s workforce reduction as a top management challenge for 2026, citing immediate gaps in operational capacity.”
  • A guest author, Kevin Hennecken (LinkedIn link), added a post (OPM link) to the OPM Director’s Secrets of OPM blog. He discusses the Tech Force that OPM is developing under the Dirctor’s leadership.

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “The Food and Drug Administration said Sunday that a laboratory finding showing cyclospora contamination in a sample of shredded iceberg lettuce supplied by Taylor Farms de Mexico was a false positive. 
    • “But the agency did not back away from its conclusion that the company remains linked to a multistate outbreak of cyclosporiasis through its traceback investigation. 
    • “FDA’s traceback investigation and outbreak data continue to converge on shredded iceberg lettuce from Taylor Farms locations in central Mexico,” the agency said on social media Monday afternoon. It said there was “overwhelming epidemiological data” to support the voluntary recall.” * * *
    • “Federal and state investigators continue to examine thousands cases of cyclosporiasis nationwide. Michigan on Monday reported more than6,000 cases.
    • “It may not be just Taco Bell, it may not be just Taylor Farms, it may not be just lettuce,” said Barbara Kowalcyk, director of George Washington University’s Institute for Food Safety and Nutrition Security. “Lots of products carry the risk of being contaminated with cyclospora.”
    • “Other products could still be implicated, Kowalcyk said. “Next week it could be something else. It could be blueberries or raspberries or basil… or a food vehicle that we haven’t identified as a way of transmitting this pathogen,” she said. “The bottom line is this investigation is not over. It’s not just Taco Bell. It’s probably not just iceberg lettuce.”
  • The New York Times adds,
    • “The leading suspect, it seemed, was the cilantro.
    • “Weeks before an outbreak of cyclosporiasis, now traced at least in part to iceberg lettuce, laid low thousands of Americans this summer, the New York City Health Department investigated a smaller outbreak. Testing labs and doctors notified the city that people were coming down with the intestinal illness, which is caused by a parasite and can result in explosive diarrhea and other types of gastric distress.
    • “The New York investigation back in April — one of multiple case clusters the city’s disease detectives have pursued this year — led to cilantro.
    • “But how exactly do health authorities figure out how people got sick?
    • “City officials shared details of the cilantro case with The New York Times. The city’s work is only one link in a chain that also involves state and federal disease surveillance efforts, but it helps illustrate how complicated it can be to pinpoint sources of contamination in a global food-supply system. The C.D.C. says it is continuing to investigate cyclosporiasis cases unrelated to the iceberg lettuce contamination.
    • “So far this year, 442 cases of cyclosporiasis have been diagnosed in the city — far above the average of 216 cases for an entire year during the period 2019 to 2024.”
  • MedTech Dive relates,
    • “Resmed has contacted customers about a ventilator issue linked to five serious injuries, the Food and Drug Administration said Wednesday.
    • “A subset of Astral 100 and Astral 150 ventilators can inadvertently enter a fail-safe state and stop delivering therapy, creating a risk of serious injury or death.
    • Resmed informed customers of the issue on June 25, asking them to continue using the devices with precautions. The FDA shared the message in an early alert notification last week.

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services released guidance July 17 on new remittance advice remark codes required for use following updates to the No Surprises Act independent dispute resolution process. RARCs are standardized codes that convey information about claims processing. The guidance specifies circumstances in which group health plans and health insurance issuers offering group or individual health insurance coverage must use each RARC and technical instructions to facilitate usage. CMS said that plans and issuers can continue to use claim adjustment reason codes they consider most appropriate for any claim adjustment. The RARCs specified apply for items and services furnished on or after Jan. 1, 2027.”

From the judicial front,

  • Bloomberg Law reports,
    • “Anthropic PBC and a group of authors received final approval Monday of their $1.5 billion settlement to end a copyright class action over the AI company’s downloading of millions of pirated books, $122 million of which will go to the authors’ attorneys and litigation costs.
    • “The pact is the largest copyright class action settlement in US history and one of the first deals in the dozens of similar lawsuits pending against AI giants including OpenAI Inc., Meta Platforms Inc., and Google. It provides about $3,100 per author of more than 480,000 works Anthropic downloaded from pirate libraries Library Genesis and Pirate Library Mirror.
    • “As of April, claims for 440,490 of the works have been filed.
    • “The deal “provides meaningful relief” to the authors and publishers given the potential range of relief, “especially since further litigation would likely be complex, expensive, lengthy, and risky,” said Judge Araceli Martinez-Olguin of the US District Court for the Northern District of California.
    • “Success at trial was not assured, and a loss would have left the Class with no recourse.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “More than 56% of U.S. adults between the ages of 30 to 79 years old are now eligible to start undergoing statins, according to new findings published in JAMA.
    • “Those numbers are based on the new dyslipidemia guidelines published in March by the American College of Cardiology, American Heart Association and several other leading medical societies.[2] The 2026 guidelines included several major changes, the researchers noted. The age range targeted for treatment broadened from 40–75 to 30–79, for example, and clinicians started focusing on 30-year risk instead of just 10-year risk. 
    • “What do these updates mean for patient care? According to the team’s analysis, many more patients—approximately 21.5 million—are now eligible for statins. 
    • “The shift to a longer view of cardiovascular disease risk is a sea change for doctors in counseling patients,” lead author Timothy S. Anderson, MD, a primary care physician and health quality researcher with the University of Pittsburgh School of Medicine, said in a statement. “We wanted to better understand the potential population-health effect of this shift.”
  • The American Medical Association lets us know what doctors want their patients to know about Crohn’s Disease.
    • “Crohn’s disease is a condition that can affect any part of the digestive system. While it affects people throughout their lives in different ways, more treatment options are now available. Physicians are also finding promising lifestyle adjustments to help with the disease.”
  • Health Day tells us,
    • “Higher levels of testosterone in girls during puberty are associated with mental health symptoms such as depression and anxiety.
    • “Testosterone increases were more significant than other hormonal changes, including estrogen.
    • “Hormones can impact the brain before puberty becomes physically apparent.”
  • and
    • “Heart-healthy vegetables may differ for men and women
    • “Men benefit most from legumes, while women benefit most from cruciferous vegetables, research shows
    • “Even one daily serving is linked to better health.”
  • The Wall Street Journal adds,
    • “An American Heart Association statement says drinking up to five cups of coffee a day is safe for most adults and might benefit heart health.
    • “Consuming three to five eight-ounce cups of coffee daily is linked to a lower risk of heart disease, stroke and Type 2 diabetes.
    • “The potential benefits of coffee can be diluted or eliminated by adding sugar, syrups and creamers with high saturated fat.”
  • Genetic Engineering and Biotechnology News relates,
    • “A vaccine to prevent pancreatic cancer, targeting common KRAS mutations, was found to be safe and stimulated KRAS-specific T-cell responses in 90% of study participants who were at high risk of developing pancreatic ductal adenocarcinoma (PDAC), according to Phase I clinical trial results. After a median follow-up of 16.5 months, none of the participants developed pancreatic cancer, and some of the precancerous lesions shrank or stopped growing. “The study represents the first proof of concept for the use of vaccines for interception of pancreatic cancer in human patients.
    • “The findings are published in Cancer Discovery, in the paper, “First-in-human Testing of a Mutant KRAS Vaccine for Pancreatic Cancer Interception in High-risk Cohorts.”

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

  • AHIP reports today that “Health Plans Are on Track to Streamline Prior Authorization.”
  • Beckers Payer Issues introduces the leader of the BCBS affiliate in every state and five AI execs driving health insurers’ strategies
  • Healio relates,
    • “Variation in facility fees was linked to significant differences in cost of cardiology services with major national insurers, according to a study published in JAMA Network Open.
    • “Facility fees varied by nearly $30,000 for certain cardiology procedures, with UnitedHealthcare and Blue Cross Blue Shield having the highest facility prices and Aetna consistently having the lowest, researchers reported.”
  • BioPharma Dive tells us,
    • “Nearly four times as many Americans are taking a GLP-1 weight loss drug now compared to two years ago. But about 20% still aren’t using an FDA-approved medicine, despite efforts to curb compounded copycats, according to a recent Gallup survey. The number could be even higher. Another 12% weren’t sure if they were using a brand-name medication.
  • and
    • “Tempus AI said Monday it has agreed to buy Personalis for $1.5 billion. 
    • “Fremont, California-based Personalis makes a molecular residual disease test for cancer. Tempus expects the acquisition will allow it to better support patients around cancer diagnostics, treatment selection, recurrence and monitoring. 
    • “The planned purchase follows recent interest in blood-based cancer tests across the medtech industry. Abbott in March closed its $21 billion purchase of Exact Sciences, Guardant’s colon cancer blood test received UnitedHealth coverage, and Freenome recently shared results of a pivotal study of its blood-based screening for colorectal cancer.”
  • STAT News adds,
    • “It’s officially a trend. For the third time in nine months, a pharma company has announced that it is assembling the largest AI supercomputer in the life sciences industry. This time, it is Bristol Myers Squibb.” * * *
    • “The Princeton, N.J.-based company’s move to own its AI infrastructure, announced on Monday, is the latest in a string of pharma bets on AI data centers. In October 2025, Eli Lilly announced it was building pharma’s largest AI data center with over 1,000 of what was then NVIDIA’s latest processors. In March, Roche announced it had the “greatest announced GPU footprint available to a pharmaceutical company” with 2,176 processors on its premises in the U.S. and Europe, plus more available in the cloud for a total of over 3,500 processors. Now BMS says it is increasing its AI computing capacity more than tenfold to become the “most powerful” AI buildout in pharma, though executives declined to specify a number of processors.”
  • Cardiovascular News informs us,
    • “Heartflow had a busy four days at SCCT2026, the annual meeting of the Society of Cardiovascular ComputedTomography (SCCT). The company’s advanced artificial intelligence (AI) technologies were at the heart of multiple presentations, for example, and it officially launched a new staging tool based on total plaque volume (TPV) calculations.
    • “Heartflow’s AI software turns coronary CT angiography (CCTA) images into personalized 3D models of the heart. With tools like Plaque Analysis and Roadmap Analysis, the company’s Heartflow One platform helps care teams explore, evaluate and manage a patient’s coronary health. 
    • “Heartflow technology was featured in eight different clinical studies presented at SCCT2026, providing an in-depth look at the cardiovascular health of more than 36,000 adult patients. DECIDE, for example, focused on registry data from nearly 12,000 symptomatic patients with zero coronary artery calcium (CAC) scores. These individuals would have typically been categorized as zero-risk patients, but researchers found that approximately one-half of the cohort actually did present with non-calcified plaques that were missed by the original CAC score.
    • “While coronary calcium scoring has been a helpful foundational tool, relying on calcium scoring alone leaves a diagnostic gap for clinicians, particularly regarding high-risk non-calcified plaque,” investigator Vincent L. Sorrell, MD, co-director of the Cardiovascular Research Priority Area at the Gill Heart and Vascular Institute at University of Kentucky HealthCare, said in a statement. “The DECIDE data demonstrate that Heartflow’s TPV-based staging unmasks important cardiovascular disease in over half of symptomatic patients who present with a calcium score of zero. This enhances our ability to accurately identify at-risk individuals and optimize preventive management based on a more precise understanding of their actual disease burden.”

Weekend Update

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

Simplicity is a virtue.

From Washington, DC

  • The House of Representatives and the Senate are in session this week on Capitol Hill for Committee business and floor voting. Punchbowl News adds,
    • “It’s the last time this will happen until the week of Sept. 14, nearly two months from now.
    • “The Senate will be in through Aug. 7, while members of the House are leaving for five weeks starting on Thursday. Yes, it’s only mid-July, but the House won’t be back until Aug. 31.”
  • Noteworthy Committee hearings include:
    • House Committee on Oversight and Government Reform
    • Wednesday July 22, 2026 10:00 AM Local Time | 2154 Rayburn House Office Building, Washington, D.C.
    • Markup: the Full Committee to consider the following: 1) H.R. 6610, Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act]; 2) H.R. 9720, D.C. Taxing Authority Review Act; 3) H.R. 9725, Restoring Integrity and Efficiency to Inspector General Oversight Act of 2025; 4) H.R. 9643, Comment Integrity and Management Act; 5) H.R. 9741, To name the DC Tuition Assistance Grant program the “Eleanor Holmes Norton District of Columbia Tuition Assistance Grant Program”; 6) Several postal naming measures.
    • Related Items: H.R.8359 , H.R.9741 , H.R.8945 , H.R.9643 , H.R.9725 , H.R.4283 , H.R.8326 , H.R.6610 , H.R.8999 ,H.R.9026 , H.R.6006 , H.R.9720 , H.R.9570 , H.R.7365 , H.R.8419
    • Meeting Details
      • The FEHBlog expects that this anti-competitive FEHB bill HR 6610 would increase the cost of prescription drugs in the FEHB and PSHB programs.
      • The meeting details note;
        • H.R. 6610, Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act]
          • A.Summary
            • The bill proscribes terms, requirements, and prohibitions for the Federal Employee Health Benefit (FEHB) program plan contracting with Pharmacy Benefit Managers (PBMs). Specifically, the bill requires PBMs to reimburse pharmacies and effectively apply the amount of pharmaceutical manufacturer rebates to the amount beneficiaries pay for respective prescription drugs. The bill prohibits PBMs from “steering” beneficiaries towards certain pharmacies and imposes noncompliance penalties, subject to specified hearing and appeals processes.
          • B. Amendments
            • The Chairman will offer an ANS.
    • Senate Committee on Health, Education, Labor, and Pensions
      • Thursday July 23 9:47 AM (EDT) – Senate | 430 Dirksen Senate Office Building, Washington, D.C.
      • Open Business Meeting: Business meeting to consider the nominations of Sean Kaufman, of Georgia, to be Assistant Secretary for Preparedness and Response, Erica Schwartz, of Florida, to be Director of the Centers for Disease Control and Prevention, both of the Department of Health and Human Services, and Keith Sonderling, of Florida, to be Secretary of Labor.
      • Related Items: PN1129 , PN932 , PN937-3
      • Meeting Details

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Taylor Farms said that the Food and Drug Administration has apologized after the agency walked back an earlier statement that the parasite linked to an outbreak affecting thousands of people had been detected on a sample of its lettuce.
    • “The FDA on Sunday said it has yet to identify the presence of cyclospora on samples of lettuce from the company despite recent tests. The agency now deems the detection that it reported Saturday a false positive after laboratory experts reviewed the sample results.
    • “Taylor Farms, which supplies some of the country’s biggest retailers and restaurants, makes a range of products from salad kits to vegetable blends. Government agencies had linked shredded iceberg lettuce—served at locations of the restaurant chain Taco Bell—to reports of foodborne-illness in five states. The company said it initiated a recall “in an abundance of caution” of its iceberg lettuce grown and processed in central Mexico. Many of its other products remain on store shelves.”
  • FEHBlog observation: Huh? Have cyclospora cases been dropping since the recall?

From the public health and medical / Rx research front.

  • WABC News in New York City reports,
    • “Officials have released new information about the second person who has died in connection to the ongoing Legionnaires’ disease outbreak on the Upper East Side.” * * *
    • “As of Saturday night, 72 people have been diagnosed with Legionnaires’ disease, and nine people are hospitalized in association with this cluster.
    • “The tragic announcement comes just days after the city revealed more than 45 additional positive tests for Legionella bacteria linked to cooling towers on the Upper East Side.
    • “So far, they have ordered a total of 76 buildings to clean their cooling towers as they work to contain the ongoing outbreak.
    • “Legionnaires’ disease is treatable but 10% of people will die due to complications from the illness, according to the U.S. Centers for Disease Control and Prevention.”
  • Medscape relates,
    • “An imaging-derived measure, the sarcopenic obesity index, predicted heart failure, cardiovascular death, and all-cause mortality better than traditional body composition measures such as BMI and waist-based ratios, capturing the combined burden of excess adiposity and low muscle mass.”
  • Beckers Behavioral Health tells us about “24 new behavioral health study findings to know,”

From the U.S. healthcare business front,

  • Beckers Hospital Review provides us with 10 things to know about the hospital profitability divide.
  • Beckers Physician Leadership points out
    • “More than 63% of physicians are already working in locum tenens or considering taking on a locum tenens role within the next five years, according to a report from Doximity.” Locus tenems means temporarily filling in for other clinicians to maintain continuity of care. Specialized staffing companies manage these fill ins for hospitals and medical practices.

Cybersecurity Saturday

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

From the War with Iran front,

  • Cybersecurity Dive reports,
    • “Threat actors linked to Iran are using artificial intelligence to enhance their cyber and information warfare capabilities, putting the U.S. and its allies at higher risk of asymmetric attack, according to a report released Thursday by Recorded Future. 
    • “Iran-nexus actors have used generative AI and large language models in a range of activities, including the development of malware, conducting research on industrial control systems, exploiting software vulnerabilities and other uses. 
    • “There are no indications yet that Iran has developed fully autonomous models, but the country is clearly using AI to accelerate its existing capabilities. 
    • “AI has not transformed Iran into a fundamentally different cyber power, but it has compressed the distance between intent and action,” Alexander Leslie, senior advisor at Recorded Future, told Cybersecurity Dive.” 

From the Project Glasswing front.

  • CRN reports,
    • “Microsoft’s unprecedented July security update—which potentially includes patches for more than 600 vulnerabilities—is confirmation that ultra-powerful AI models for discovering software flaws are already starting to signal massively bigger challenges in vulnerability management, according to MSP executives.
    • “For months, the industry has been watching for indicators that vulnerability discovery capabilities from frontier AI models such as Anthropic’s Claude Mythos would lead to increased CVEs (Common Vulnerabilities and Exposures). While some hints of this had surfaced previously, the hundreds of CVEs that received software patches Tuesday as part of Microsoft’s monthly release of software bug fixes is the clearest sign of this yet, MSP executives told CRN.
    • “Estimates of the number of vulnerabilities disclosed by Microsoft during the release, colloquially known as “Patch Tuesday,” have varied but could be above 600, according to TrendAI’s Zero Day Initiative. Dustin Childs, head of threat awareness at TrendAI, counted 621 new Microsoft CVEs for the July security update.
    • “The bug apocalypse has fully descended upon us,” Childs wrote in a post.” * * *
    • “Microsoft has been among the tech industry vendors that have received access to Anthropic’s Claude Mythos model for the purposes of proactively discovering vulnerabilities in its own products, as part of the Project Glasswing initiative announced in April. Similarly, OpenAI has provided Microsoft with access to its frontier AI vulnerability-discovery models through its Trusted Access for Cyber initiative.”

From the cybersecurity and law enforcement front,

  • Cybersecurity Dive reports,
    • “The Trump administration on Tuesday [July 14] announced the launch of a program that will coordinate the security community’s use of frontier AI models to rapidly identify and fix vulnerabilities.
    • “The vulnerability management clearinghouse, which the administration is calling Gold Eagle, is a response to the skyrocketing number of vulnerabilities that AI models are finding and the strain that that surge is placing on the security community. Through the clearinghouse, the government will coordinate efforts by private companies and independent researchers to scan critical software packages for flaws, fix any flaws that surface and deploy those fixes to end users.” * * *
    • “Gold Eagle “has already begun to intake and prioritize identified cybersecurity vulnerabilities from across industries and sectors, coordinate scanning verifications, and ultimately ensure the security of our nation’s software and networks,” the White House said in a statement.
    • “The core of the Gold Eagle program is the Vulnerability Information and Coordination Environment (VINCE), which the government is operating in partnership with Carnegie Mellon University’s Software Engineering Institute. The VINCE platform will allow anyone to report vulnerabilities to the Gold Eagle program for triage and mitigation.
    • “VINCE will enable “vulnerability and patching coordination at a speed and scale never seen before,” National Cyber Director Sean Cairncross told reporters during a briefing on Tuesday.
    • “Gold Eagle will focus heavily on open-source software, whose code underpins a wide range of critical infrastructure but is often poorly scrutinized.”
  • Dark Reading adds,
    • “Katie Moussouris, founder and CEO of Luta Security as well as a pioneer in vulnerability remediation, tells Dark Reading that the cross-sector vulnerability coordination gap Gold Eagle targets “is real,” as the Known Exploited Vulnerabilities (KEV) catalog, National Vulnerability Database (NVD), and Information Sharing and Analysis Center (ISACs) do not address cross-sector prioritization. And as she has long said, vulnerability management policy problems don’t resolve on their own.
    • “The bottleneck was never knowing about more bugs. It was having the people and process to prioritize and fix them and ensure they do not recur,” she says. “Remediation prioritization according to the new BOD 26-04 will take skills and process at each affected organization, by definition, since two and possibly three out of four of the prioritization criteria are subjective and specific per organization.” * * *
    • “Moussouris cited CISA’s recent postmortem on its AWS keys being exposed in a public GitHub repository for six months as an example of something that highlights pre-existing process weaknesses at the federal level.” * * *
    • Knostic chief AI officer Sounil Yu says that if the government wants to help stakeholders via “frontier AI capabilities,” the most useful application would be something that accelerates the implementation of vulnerability fixes.
    • “Finding vulnerabilities proactively has not been the constraint. Even finding a fix or patch has not been a significant constraint. The constraint has traditionally been in implementing the fix wherever the software has been deployed,” he says. “But if you unpack it further, it’s deploying the fix and then recertifying that everything is working as expected.”
    • “Similarly, Sachin Jade, chief product officer at Cyware, tells Dark Reading that while AI tools can surface vulnerabilities faster than anyone can currently act on them, there is also a lag in determining which findings are real, prioritizing severity, and developing and deploying a fix.
    • “This program is a good start, and we as the industry have to work collectively to sharpen our approaches, increase defense velocity, empower sharing and collective defense, and become proactive in our mindsets,” Jade says.”
  • Beckers Health IT asks and answers “Healthcare Security Teams Have More Alerts Than Ever. So Why Is Risk Still Getting Through?”
    • “People remain the core of healthcare cybersecurity. When automation handles repetitive work, analysts can focus on meaningful threats, response planning and the gaps most likely to affect the organization.
    • “IBM found that organizations extensively using AI and automation in security operations identified and contained breaches 80 days faster and experienced an average of $1.9 million less in breach costs. That does not mean technology replaces experienced professionals. It shows what can happen when they receive better-organized information sooner.
    • “The most resilient healthcare organizations will be the ones that can work through data faster, identify what is relevant and act within clear safeguards before a security gap interrupts claims or patient care.”
  • Security Week relates,
    • “The Department of War has suspended CMMC Phase 2’s mandatory third-party assessment requirement, citing concerns that the assessor ecosystem couldn’t scale to meet demand and that compliance costs were pushing small and mid-sized firms out of the defense industrial base. 
    • “A newly formed CMMC Reform Task Force will spend 60 days reviewing the program, gathering industry feedback, and reporting recommendations by mid-September. 
    • Crucially, the pause only affects independent verification, with Phase 1 self-assessment obligations, SPRS score submissions, and the underlying DFARS 252.204-7012 requirement to protect controlled unclassified information (CUI) remaining fully in effect. 
    • “Industry professionals broadly agree that the suspension pauses third-party CMMC audits but not the underlying legal obligation to protect CUI, warning that self-attestation without verification raises False Claims Act exposure. However, experts are split on whether the fix should be to scope assessments down, automate them, or preserve them largely as-is.”
  • Per a July 15, 2026, Cybersecurity and Infrastructure Security Agency (CISA) news release,
    • “Today, the Cybersecurity and Infrastructure Security Agency (CISA), in partnership with the National Security Agency (NSA), Japan Computer Emergency Response Team Coordination Center (JPCERT/CC), Netherlands’ National Cyber Security Centre (NCSC-NL), and United Kingdom’s National Cyber Security Centre (NCSC-UK), published Establishing a Coordinated Vulnerability Disclosure Program to Work With Security Researchers.
    • “This guidance helps software manufacturers and online service providers collaborate effectively with security researchers who identify weaknesses in software, networks, and hardware in a structured, transparent framework. A well-defined coordinated vulnerability disclosure (CVD) program enables software manufacturers and online service providers to better assess potential risk, improve their vulnerability management processes, and make informed decisions that improve product security for their customers.
    • “Coordinated vulnerability disclosure is foundational to building a secure software ecosystem. The practices in this guide help protect customers, strengthen products and support CISA’s Secure by Design initiative, which encourages companies to be transparent and responsible in how they build and maintain their technology,” said Acting Executive Assistant Director for Cybersecurity Chris Butera. “CISA encourages suppliers to establish a coordinated vulnerability disclosure program and build constructive, collaborative relationships with security researchers to enhance product security.”  
  • Cyberscoop tells us
    • “A total of eight cyber personnel have served in a program that began in 2022 to rotate workers between federal agencies to bolster the workforce, a watchdog report said Thursday.
    • “Over the life of the Federal Rotational Cyber Workforce program that effectively went away last year, 13 agencies offered 106 positions and received 634 applications, according to the Government Accountability Office. Eight workers won approval to participate.
    • “The goal of the Office of Personnel Management-led program, established by bipartisan legislation, was that “participating employees develop knowledge and skills that they can bring back to their home agencies,” as the GAO noted.
    • “OPM evaluated possible shortcomings in implementing the program in late 2024 and developed plans for improving it, but never followed up on them, the GAO said. As of next summer the program will officially end, OPM said.”
  • and
    • “A pair of young men were sentenced to 66 months in jail for committing acyberattack on the Transport for London that brought the network’s operations to a standstill in 2024, the United Kingdom’s National Crime Agency said Thursday [July 16].
    • “Thalha Jubair and Owen Flowers were arrested at their homes in September 2025, barely a year after the attack, and pleaded guilty last month just as their trials were set to begin. Flowers was previously arrested in connection with the attack in September, but was released after questioning by officers.
    • “Jubair and Flowers were leading members and highly involved in Scattered Spider, a nebulous hacker subset of The Com, according to researchers. The 20-year-old Jubair was a prolific cybercriminal and core member of the unbound collective. 
    • “U.S. authorities last year accused Jubair of direct, prominent involvement in at least 120 cyberattacks, including extortion of 47 U.S.-based organizations and the January 2025 attack on the federal court system. 
  • Beckers Health IT identified 11 cases from a Federal crackdown on hospital hackers.
    • “Federal authorities are intensifying their pursuit of the cybercriminals behind hospital and healthcare ransomware attacks, bringing charges against ransomware developers, state-sponsored hackers and even insiders from the cybersecurity industry.
    • “The latest move came July 14, when the Justice Department indicted three Russian nationals and two “bulletproof hosting” companies tied to $62 million in U.S. victim losses. The action is part of Operation Riptide, the FBI’s ongoing campaign against cybercrime infrastructure, after Americans reported more than $20 billion in cybercrime losses last year, a 26% single-year increase.”

From the cybersecurity breaches and vulnerabilities front,

  • HIPAA Journal posted its May 2026 Healthcare Data Breach report last Tuesday.
    • “Based on the current data on the HHS’ Office for Civil Rights (OCR) breach portal, 61 healthcare data breaches affecting 500 or more individuals were reported in May 2026. May’s current total represents a 27.1% month-over-month increase in data breaches. Over the past 12 months, an average of 64 large healthcare data breaches were reported each month.”
  • MedTech Dive reports,
    • “Abbott disclosed on Thursday [July 16] that a cyberattack hit its cancer diagnostics business.
    • The medical device company said in a statement posted to its websitethat there was unauthorized access to a limited number of internal systems in its cancer diagnostics business. There was no impact on other Abbott businesses, sites or systems.
    • Abbott’s cancer diagnostics business includes Exact Sciences, which the company acquired in a $21 billion deal earlier this year. The legacy Exact Sciences systems are separate from Abbott’s, according to the statement.
  • Beckers Health IT relates,
    • “A cyberattack on New Jersey law firm Greenbaum Rowe Smith & Davis has exposed data on 12,801 patients across three health systems in the state.
    • “Greenbaum discovered unauthorized access to its systems through a compromised user account in November 2025 and traced the intrusion to Nov. 25-27, 2025, according to the firm’s notification. Affected organizations include Edison, N.J.-based Hackensack Meridian Health, Morristown, N.J.-based Atlantic Health and Trinitas Regional Medical Center in Elizabeth, N.J., part of West Orange, N.J.-based RWJBarnabas Health.
    • “An investigation completed in April found an unauthorized third party accessed patient names, addresses, medical record numbers, medical history, provider details, medical bill amounts and health insurance information. For a subset of individuals, Social Security numbers or dates of birth also were exposed, Greenbaum said.”
  • Bleeping Computer tells us,
    • “Ernst & Young is notifying customers of a data breach caused by the compromise of a third-party support ticket system used by its IT personnel.
    • “According to the company, support tickets submitted through the platform may have included documents containing client tax information.
    • “Ernst & Young (EY) is among the world’s four largest auditing and professional services providers, offering auditing, tax, consulting, and transaction advisory services to major organizations in more than 150 countries.” * * *
    • “Ernst & Young says it secured its systems and notified federal law enforcement authorities, while it has assured that the unauthorized access has been removed.
    • “The company also states that it is not aware of any misuse or further exposure of the stolen files and has no indication that particular individuals were targeted by the threat actors.”
  • CISA added ten known exploited vulnerabilities to its catalog this week.
    • July 13, 2026
      • CVE-2008-4128 Cisco IOS Cross-Site Request Forgery Vulnerability
        • Security Affairs discusses this KVE here.
    • July 14, 2026
      • CVE-2026-15409 SonicWall SMA1000 Appliances Server-Side Request Forgery Vulnerability
      • CVE-2026-15410 SonicWall SMA1000 Appliances Code Injection Vulnerability
      • CVE-2026-56155 Microsoft Active Directory Federation Services Insufficient Granularity of Access Control Vulnerability
      • CVE-2026-56164 Microsoft SharePoint Server Missing Authentication for Critical Function Vulnerability
        • The Hackers News discusses the SonicWall KVEs here
        • Cybersecurity News discusses the Microsoft Active Directory KVE here.
        • Cybersecurity News discusses the Microsoft Sharepoint Server KVE here.
    • July 15, 2026
      • CVE-2023-4346 KNX Association KNX Protocol Connection Authorization Option 1 Overly Restrictive Account Lockout Mechanism Vulnerability
      • CVE-2026-46817 Oracle E-Business Suite Improper Privilege Management Vulnerability
        • The Hacker News discusses these KVEs here.
    • July 16, 2026
      • CVE-2026-25089 Fortinet FortiSandbox OS Command Injection Vulnerability  
      • CVE-2026-39808 Fortinet FortiSandbox OS Command Injection Vulnerability  
      • CVE-2026-58644 Microsoft SharePoint Deserialization of Untrusted Data Vulnerability 
        • Bleeping Computer discusses the Fortinet KVEs here.
        • The Hackers News discusses the Microsoft Sharepoint KVE here.
  • The American Hospital Association News adds,
    • “The Cybersecurity and Infrastructure Security Agency has issued an alert warning of four Microsoft SharePoint vulnerabilities being exploited by cyber threat actors. CISA said the vulnerabilities affect all supported on-premises versions of SharePoint Server, including the Subscription Edition, 2019 and 2016. Threat actors can establish remote code execution and perform other actions to deploy malware. CISA said organizations should monitor SharePoint Servers closely for any signs of exploitation or unusual activity. An additional vulnerability was found, but it is not yet known to have been exploited. Microsoft identified it as a potential risk if it is left unpatched. CISA urged organizations to apply the latest patches and security updates from Microsoft, among other recommendations. 
    • “Nearly everyone using Microsoft products is using SharePoint, the backbone of the Office suite,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “Hospitals with their SharePoint instances housed on premises should pay particular attention to this alert. The common vulnerabilities and exposures listed in the report have patches available, and they should be deployed as soon as possible. Hospitals should also verify that the security measures mentioned are in place.” 
  • and
    • “The Cybersecurity and Infrastructure Security Agency and other U.S. and international agencies released a joint advisory July 13, warning of Russian cyber actors targeting vulnerable network devices, primarily routers, in critical infrastructure sectors globally, including healthcare. The advisory details how the threat actors primarily use scanning to identify poorly configured devices for exploitation. The actors then exfiltrate sensitive information and facilitate malicious activity. The advisory includes recommendations to help defend against potential threats.
    • “This malicious cyber activity has been attributed to the Russian Federal Security Bureau, a foreign intelligence agency of the Russian government,” said John Riggi, AHA national advisor for cybersecurity and risk. “Therefore, this represents an advanced and persistent cyber threat targeting U.S. healthcare that should be prioritized. The first step in mitigating this threat and other nation-state cyber threas is to install the latest network router encryption standard, Simple Network Management Protocol v3.”
  • Cybersecurity Dive tells us,
    • “Businesses should be on guard for a hacking campaign in which attackers spoof OAuth client IDs to collect information about targets’ user directories, the security firm Proofpoint said on Monday.
    • “The security firm said it had observed “multiple campaigns at scale abusing spoofed OAuth application identifiers, with distinct tooling, infrastructure, and execution patterns indicating independent adoption by multiple threat actors.”
    • “The report explains how organizations should monitor their networks for this reconnaissance technique.”
  • Cyberscoop points out,
    • “Cyberstalkers are increasingly exploiting a feature in Google Chrome meant for mobile phone user convenience, but can give intruders broad access to a device owner’s private information, according to researchers.
    • “Certo Software said in a blog post Tuesday that stalkers are making use of Chrome’s sync capability — meant to make it so signing into Chrome on one device makes it easier to do so on other devices, too — to spy on a phone owner’s browsing history and gain access to their stored passwords.”
  • Bleeping Computer adds,
    • “A flaw in Anthropic’s Claude for Chrome browser extension could allow a malicious extension to trigger predefined AI actions by simulating user clicks, potentially allowing it to abuse Claude’s access to connected services such as Gmail, Google Docs, Google Calendar, and Salesforce.
    • ‘The issue was discovered by Ax Sharma of Manifold Security, who says it stems from how the Claude extension determines whether a user intentionally requested one of its built-in tasks.
    • “Chrome extensions with permission to run on a website can inject JavaScript into the page, allowing them to read and modify its contents. This includes changing page elements, reading information displayed on a site, and generating click and keyboard events programmatically.
    • “According to Manifold’s report, the Claude extension listens for click events on a specific page element that launches one of its built-in AI workflows. These workflows are predefined tasks that allow Claude to perform actions in connected services such as Gmail, Google Docs, Google Calendar, and Salesforce.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Coca-Cola on Thursday said it is investigating a ransomware attack that impacted its Fairlife dairy unit and has suspended production at the company’s U.S. production facilities. 
    • “In a filing with the Securities and Exchange Commission, the company said it trying to determine the full scope of the attack and what impact it might have on its business. Coca-Cola said the attack has had no effect on the quality and safety of its Fairlife products, which include ultra-filtered, lactose-free milk as well as protein and nutritional shakes.”
  • Per a Sophos news release,
    • “This year’s data has a few eyebrow-raising departures from the patterns of past State of Ransomware reports. Exploited vulnerabilities lost their three-year grip on the top root-cause spot. Median ransom demands and payments both dropped, yet the average recovery bill still climbed. And small organizations (100-250 employees) are falling further behind their larger peers on the one metric that matters most: stopping the attack before data gets encrypted.
    • “The seventh annual Sophos State of Ransomware report is based on a vendor-agnostic survey of 2,158 IT and security leaders whose organizations were hit by ransomware in the last 12 months.
    • “Click here to access the full report now.”
  • Dark Reading adds,
    • “According to Sophos’ survey, malicious email (26%) and phishing (24%) dethroned the three-year reign of vulnerabilities (18%, down from 32%) as the top root cause of ransomware attacks. Two-thirds (67%) of victims also said the ransomware attack they suffered was their most significant identity attack over the past year.
    • “With phishing and malicious email now accounting for half of all ransomwareroot causes in this report, organizations should deploy advanced email filtering, implement DMARC/DKIM/SPF protocols, and invest in regular phishing awareness training,” Sophos said. “The shift toward email-based attacks suggests that technical vulnerability patching alone is insufficient.”
    • “The third most common root cause of ransomware attacks was also identity related, with compromised credentials used in 23% of cases. This is particularly significant because of one of the most startling findings: Multifactor authentication (MFA) was deployed for 97% of instances where compromised credentials were the root cause of ransomware attacks.” * * *
    • While staying patched remains important as always, it appears the fight against ransomware is moving from patch management to identity protection.
    • “Organizations should prioritize identity threat detection and response (ITDR), enforce multifactor authentication across all access points, and regularly audit both human and non-human identity credentials,” Sophos said. The vendor stopped short of recommending a specific type of MFA, suggesting the biggest failure wasn’t MFA itself but rather incomplete deployment or perhaps a lack of comprehensive inventorying.”
  • InfoSecurity Magazine lets us know,
    • “The number of ransomware attacks which target government departments and agencies has risen to the extent that one has its services restricted by encryption every single day.
    • “The figure comes from analysis by researchers at Comparitech, who studied ransomware incidents which targeted government entities between January and June 2026.
    • The research, published on July 16, recorded that 187 government organizations were hit with ransomware during the first six months of 2026. That represents a 13% increase on the 165 ransomware attacks recorded during the second half of 2025.
    • “The increase in recorded ransomware events is notable because the figure of 187 incidents across 182 days means that the average number of ransomware attacks against government bodies now stands at an average of one every day.
    • “Of those 187 recorded incidents, just over half (89) were publicly confirmed by the organization which was hit.”
  • Bleeping Computers warns
    • “A new ransomware actor called Spirals completed a corporate intrusion, from initial access to data theft and encryption, in less than 24 hours.
    • “The attack occurred in June and breached an IT services firm in South Asia after compromising an Internet Information Services (IIS) server exposed on the public web.” * * *
    • “Symantec’s report provides network indicators and file hashes associated with the documented Spirals attack to help organizations worldwide set up defenses against this threat group.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports
    • “Cybersecurity mergers and acquisitions reached 219 in the first half of 2026, putting the sector on track to surpass last year’s 400 deals.
    • “The rush to acquire artificial-intelligence capabilities is driving the surge in cybersecurity dealmaking.
    • “Technology and cybersecurity companies accounted for 88% of disclosed cyber acquisition spending in the first half of the year.”
  • Cybersecurity Dive relates,
    • “Enterprise security teams are incorporating AI into their programs at a faster rate than ever before, but a significant gap exists in the governance policies that are designed to support that expansion, according to a report released Monday by the SANS Institute.
    • “Four out of 10 security practitioners said there is no formal policy in their organization for AI adoption, according to the report. More than six of 10 practitioners said they have no visibility into where AI models are being used or what kind of information is being exposed. 
    • “About 75% of security practitioners have a governance role related to enterprise AI, yet more than half of respondents said there are no established frameworks for AI audits, the report showed.”
  • Dark Reading adds,
    • “Having completed its $32 billion acquisition of Wiz earlier this year, Google is fulfilling its plan to automate threat detection, investigation, and remediation with a new “agentic defense” platform built around intelligent security agents.
    • “Wiz, founded in 2020, quickly became one of the fastest-growing cloud security companies by introducing graph-based analysis to correlate cloud assets, identities, vulnerabilities, and exposures across multicloud environments. The acquisition gives Google a cloud-native security platform that supplements its existing artificial intelligence (AI), threat intelligence, and incident response features.
    • “On Monday [July 13], Google revealed it had integrated Wiz attack surface management (ASM) and Google Threat Intelligence (TI). When Wiz ingests posture and workload telemetry from Google Cloud, it enriches detections in real time with Google TI and pushes prioritized exposure data directly into SecOps playbooks and cases, enabling SOC teams to investigate and respond to cloud‑native risks without switching between tools.
    • “The integration builds on Google’s AI Threat Defense, launched in May, and other automation capabilities that combine Gemini with Wiz’s scanning, simulation, and remediation to counter AI-powered threats. It leverages the reasoning capabilities of its Gemini AI modeling platform and other frontier models alongside Wiz’s contextual risk prioritization capabilities. Google AI Threat Defense uses Gemini’s code remediation features and CodeMender, along with expertise from Mandiant.”
  • Cyberscoop notes,
    • “As AI-enabled hacking becomes a bigger threat for cybersecurity and national security, public attention has focused on mainly a few leading frontier AIcompanies developing more powerful large language models.
    • “These models, and the billions of dollars behind them matter, but they’re only part of a larger shift. Enterprises are now building their own technology platforms that take these general-purpose LLMs and turn them into bespoke cybersecurity tools.
    • “Industry professionals refer to these tools as a “harness.” They control the model’s behavior, limit its risks, and connect it to internal IT systems and networks so it can work reliably at scale.
    • “New research from Cato Networks shared exclusively with CyberScoop shows how much power can come from a harness. It paired OpenAI’s ChatGPT 5.5 and GPT 5.5-Cyber models with its own tool and tested the abilities of the agent to hack into a victim network with as little human direction as possible.” * * *
    • “Dan Rapp, chief AI and data officer at Proofpoint, said their harness, “Satori,” has become a critical tool for keeping their agentic AI on track while giving humans the ability to step in when things go awry.
    • “I think what you’re seeing in the foundation of frontier models is you have raw intelligence, raw reasoning power, but to get these systems to perform the way you want to, both context engineering – the content provided ensuring that its accurate and relevant – and the harness engineering are essential to actually get the systems to perform well,” Rapp told CyberScoop.”
  • Dark Reading explains how to “Manage Vendor Risk in a Few Practical Steps.”
    • “Risk tolerance, exposure visibility, board oversight — handling third-party risk is complicated but achievable with disciplined, precise governance.”
  • Tech Target highlights “Multifactor authentication: 5 examples and strategic use cases.”
    • “Before implementing MFA, conduct a careful study to determine which security factors offer the strongest protection. Passwords and PINs aren’t cutting it any longer.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Politico reports,
    • “House GOP leaders released text Friday for a bill to fund the vast majority of the federal government from the start of the next fiscal year on Oct. 1 until after the midterm elections — bypassing the bipartisan appropriations process and daring Democrats to pick a shutdown fight months before voters head to the polls.
    • “Speaker Mike Johnson said Thursday he plans to put the legislation on the floor next week.
    • “The measure would fund the government through Dec. 4 and, as Republican leaders promised, would not include additional policy riders or unrelated provisions.”
  • Roll Call offers a wrap up of this week’s activities on Capitol Hill.
  • STAT News relates,
    • “Pretty much everyone who cares about public health agrees that it’s a good idea to help people quit smoking, the No. 1 cause of preventable death in the U.S. Doctors may soon get some extra encouragement to lend a hand, thanks to proposed changes in Medicare’s physician fee schedules.
    • “Physicians who offer counseling on quitting cigarettes or other tobacco products during visits with patients would get a 19% increase in reimbursement, according to a few paragraphs buried in the 1,592-page document released this week. The same adjustment would also apply to assessments of, and interventions for, alcohol and substance misuse during doctors’ visits.
    • “Given the evidence supported role these services play in preventing and managing chronic disease […] we believe that valuation should more accurately reflect the clinical intensity and work associated with these time-based services,” the proposal from the Centers for Medicare and Medicaid Services explains. Comments on the proposal are due Sept. 14. 
    • “The prioritization of cessation as a service is long overdue, and we’re very excited about it,” said Anne DiGiulio, the American Lung Association’s senior director of nationwide tobacco cessation and health policy.”
  • Health Day adds,
    • “For people assigned to smoking very low nicotine-content cigarettes (VLNCs), there is minimal evidence for compensation for reduced nicotine levels, according to a review published online July 15 in JAMA Network Open.
    • “Rachel L. Denlinger-Apte, Ph.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues examined whether people who smoke may increase their smoking to compensate for the reduced nicotine levels when smoking VLNCs for prolonged periods. Data were obtained from 17 randomized controlled trials published between 2010 and 2024, representing 5,500 adolescents and adults who smoked cigarettes daily or nondaily. A subset of 2,454 participants from seven trials were included in the pooled meta-analysis.”
  • Food Dive relates,
    • “The FDA’s acting head of food on Tuesday [July 14] admitted crafting its highly anticipated definition of ultraprocessed foods is proving “quite challenging,” though he added it’s still a “priority” for the agency.
    • “Just because it’s a tough challenge, it doesn’t mean it’s something that we should shy away from,” Donald Prater, FDA’s acting deputy commissioner for food, said during a keynote at the IFT First conference in Chicago.
  • Genetic Engineering and Biotechnology News adds,
    • “Ketogenic diets, originally developed in the 1920s to treat epilepsy, have been adapted in the past few decades as a strategy to lose weight or increase lifespan. This type of diet (a high percentage of fat, low percentage of carbohydrates, and normal or reduced amounts of protein) forces the body to burn fatty acids for energy in place of carbohydrates such as glucose. Burning these lipids produces ketone bodies—primarily β-hydroxybutyrate (BHB) and acetoacetate—as byproducts of fatty acid metabolism. The impact of ketogenic diets on the gastrointestinal tract remains poorly understood.
    • “In recent years, scientists investigated whether this type of diet might affect the development of cancer. While some research has shown that the diet may protect against the development of colon cancer, a new study suggests that in the small intestine, a ketogenic diet may increase the risk of cancer—with a mechanism through fatty acid oxidation rather than ketone metabolism.”
    • “This work appears in Nature in the paper, “Ketogenic diet mediates intestinal tumorigenesis through lipids not ketones.”

From the Food and Drug Administration,

  • Fierce Pharma reports,
    • “With two approved medicines to treat primary immunoglobulin A nephropathy (IgAN) and a third therapy in phase 3 testing, Novartis is on its way to cornering the market for the indication.
    • “On Friday its first drug to hit the market for IgAN, Fabhalta, gained a full blessing from the FDA, with the U.S. regulator converting the drug’s accelerated approval into a traditional nod. Fabhalta is now endorsed to slow kidney function decline in adult IgAN patients who are at risk for disease progression. 
    • “The original, speedy IgAN approval for the first-in-class factor B complement inhibitor came two years ago to reduce proteinuria.”
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has shared updated recommendations about recalled thoracic stent grafts. Customers were previously told they could still use the devices as long as they were aware of the risk and knew how to respond if an issue occurred. Now, however, the FDA is emphasizing that these devices should be returned to the manufacturer and not be used to treat any other patients.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has temporarily halted provisions of a rule from the Trump administration meant to reshape the Affordable Care Act exchanges days before they were scheduled to go into effect.
    • “On Thursday, a Maryland district court determined the coalition of cities and provider groups that filed a lawsuit challenging the rule would suffer “irreparable harm” from the policies, including the expansion of bare-bones catastrophic coverage and stricter verification of enrollees’ eligibility for subsidies.
    • “The stay is a victory for insurers, given it staves off further disruption to the already destabilized ACA marketplaces. However, the relief may be short-lived, as some of the policies codified in the GOP’s “Big Beautiful Bill” will be enacted in 2028.”

From the public health and medical / Rx research front,

  • The Centers for Medicare and Medicaid Services announced today,
    • “As of July 17, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “COVID-19 activity is very low and stable nationally but is beginning to show early signs of an increase, mainly in the South.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Rhinovirus/enterovirus (RV/EV) activity is elevated in some regions. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 29 newly confirmed cases, the the US measles total is just 29 cases short of last year’s sobering total, the Centers for Disease Control and Prevention (CDC) said in an update today.
    • “The CDC announced 2,260 confirmed cases so far in 2026, all but 15 of them locally acquired. The total for all of last year was 2,289 infections, which was the most since 1991. The country could lose its measles elimination status this fall, which it gained in 2000.
    • Of the 2,260 cases for the year, 20% of infections are in children age 5 and under, and 70% involve kids and young adults to age 19. Six percent of patients have been hospitalized, compared with 10% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status. 
    • “No measles deaths have been reported this year, compared with three in 2025.”
  • MedPage Today adds,
    • “Declining U.S. vaccination rates have led to a resurgence in large measles outbreaks.
    • “Two papers examining South Carolina and Utah’s outbreak showed that hypoxemia and pneumonia were the most common conditions leading to hospitalization for measles.
    • “In the South Carolina report, two of 13 hospitalized patients developed measles encephalitis, a life-threatening complication that can cause brain damage.”
  • The American Hospital Association points out,
    • “A Centers for Disease Control and Prevention report released July 16 found that wastewater surveillance failed to detect an internationally circulating measles genotype that accounted for about 5% to 10% of U.S. measles cases in 2025, highlighting potential challenges of using wastewater surveillance as a public health tool. The report said that of two unrelated measles cases reported to the Wisconsin Department of Health Services in February 2026, wastewater surveillance detected one case before the case was reported. The second, caused by the international B3 genotype, was undetected. Public health officials later released a modified laboratory procedure that improved the detection of the B3 genotype. The CDC said that wastewater testing should be standardized and revalidated against circulating viruses and supported by publicly available whole-genome sequencing data.”
  • The Washington Post reports,
    • “Taylor Farms announced Friday that it is “voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market,” after federal investigators identified some of the lettuce it provided to Taco Bell restaurants as linked to one of the largest U.S. outbreaks of cyclosporiasis this summer. 
    • “The company said in a statement that it made the decision based on information provided by the Food and Drug Administration, whose investigators had traced the outbreak to “a specific independent farm” representing less than 1 percent of the U.S. iceberg lettuce supply. The company added that it would remove all iceberg lettuce from the region indefinitely “out of an abundance of caution.”
    • “The company said no other Taylor Fresh Foods products across the country are impacted. It said no Taylor Farms branded salad kits contain iceberg lettuce.” * * *
    • “Other companies have begun to respond to a parasite-borne illness that has sickened thousands, and the federal health investigation has widened beyond Taco Bell restaurants. Sysco, one of the world’s largest food suppliers, on Thursday voluntarily stopped distributing certain iceberg lettuce products from Mexico after the agency said it was tracing where the contaminated lettuce may have been distributed throughout the food supply.”
  • The Wall Street Journal explains “What to Know About the Cyclosporiasis Outbreak and How to Stay Safe”
    • “More than 30 states have reported cases of the illness. Taco Bell’s lettuce is linked to cases in at least five states.” * * *
    • “Norovirus is a highly contagious virus that can cause vomiting and diarrhea, but it typically comes on within 12 to 48 hours of exposure and lasts one to three days. 
    • “Cyclospora, on the other hand, can cause weeks of relapsing diarrhea where someone gets sick, feels better, and then gets sick again, said Caitlin Rivers, director of the Center for Outbreak Response Innovation and an associate professor at the Johns Hopkins Bloomberg School of Public Health. “It lasts much longer than a stomach bug where you’re sick for a day and you bounce back.” 
    • “Another big difference: Many foodborne illnesses, like norovirus, are highly infectious and spread between humans through something as simple as touching a doorknob. 
    • “One piece of good news: Cyclosporiasis is rarely contagious between people.” 
  • The Washington Post tells us,
    • “Plumes of thick, toxic wildfire smoke from fires burning in Canada are billowing into the United States. The phenomenon, where smoke blots out the blue sky overhead, making the air appear milky-white or even orange, has become a relatively regular fixture of summers where out-of-control wildfires in the West bring noxious smoke downwind.” * * *
    • “There’s essentially a west-to-east conveyor belt that’s pumping high-altitude smoke eastward. That’s because the smoke is surfing the jet stream, a river of swiftly moving winds in the upper atmosphere. The jet stream is cresting around a ridge of high pressure parked over the central states.
    • “The smoke is also being steered by persistent troughing, or areas of low pressure, east of the Hudson Bay in northern Quebec. That counterclockwise-spinning low induces northwesterly winds, which are winds that blow from the northwest and pump the smoke in a southeast direction.
    • “That brings surface-level smoke into the Lower 48 in copious quantities. Medium-range weather models suggest a similar pattern continues into late July, meaning smoke will continue taking this trajectory.” * * *
    • “As of early Friday morning, Chicago, Detroit, D.C. and New York City were the most polluted major cities in the world — exceeding Delhi and Kolkata, India; Jakarta, Indonesia; and most major cities in China.”
  • Kaufmann Hall notes,
    • “Less than half of adults in rural communities have had a routine medical visit or cancer screening in the past year, according to a recent survey by the Prevent Cancer Foundation. The broader survey of U.S. adults found that half of all respondents expressed concerns and confusion about the cost of medical screenings. Nearly 15% of respondents also expressed concerns about the costs of follow-up appointments and lost wages. The news comes as the American Association for Cancer Research’s latestprogress report finds that declines in cancer death rates have been slower among rural residents than those living in urban areas.”
  • The Wall Street Journal journalist lets us know “I Tested My Blood for Microplastics. I Got a Number, but Few Answers.
    • “Plastics are accumulating in our bodies, but scientists aren’t sure how bad that is for our health.”
    • “Microplastics are ubiquitous. Bottled water and processed food are big culprits. So is clothing, furniture and just about everything else.
    • “It’s hard to find things that are not made of plastic,” says Phoebe Stapleton, an associate professor in the department of pharmacology and toxicology at the Ernest Mario School of Pharmacy at Rutgers University. 
    • “And they get into our bodies through both ingestion and inhalation. There hasn’t been a tissue or organ in the body where microplastics haven’t been found. Lungs, heart, kidneys, liver, brain, testicles, the fluid in our eyes, and ovaries—all have microplastics, says Stapleton.
    • “No wonder there’s more interest in testing. The blood test has been commercially available since 2023. I purchased it for $135 through Bryan Johnson’s longevity health site, Blueprint.” 
  • STAT News informs us,
    • “For the last year, a small California startup has been making extraordinary claims about the ability of its technology to potentially treat Duchenne muscular dystrophy — and maybe a slew of other genetic diseases, too.
    • “The company, Sonothera, does not yet have clinical data. But it’s presented data in animals so stunning that other experts can’t quite wrap their minds around it.” * * *
    • “The technology in question is ultrasound — yes, the same technology used for imaging pregnancies. Sonothera is using it to deliver replacement genes into the muscles of mice and monkeys.
    • “The approach marks a radical departure in the gene-therapy field, which has long relied on viruses to ferry genes into cells. Those viruses, while occasionally powerful, have severe drawbacks. They can only deliver genes of a certain size and can only be administered once, after which patients develop immunity. If the first treatment didn’t get enough of the gene to enough cells — well, you’d better have some other fix.” * * *
    • “Answers may come soon in clinical trials. Sonothera’s backers point to multiple pieces of supporting evidence, including improved muscle function in mice. And the company is still optimizing its therapy. 
    • “For humans, Sonothera’s goals are far more modest than what was achieved in some of its studies: a 15% increase in dystrophin, while creating protein in at least 20% of a patient’s muscle fibers.”
  • Per BioPharma Dive,
    • “GSK is discontinuing trials of an experimental chronic cough medicine it bought in a $2 billion deal three years ago, announcing Friday that camlipixant had failed to meet nearly all of the goals in two Phase 3 trials. The British pharmaceutical giant said the “limited efficacy demonstrated is unlikely to transform patient care.”
    • “The termination closes a blockbuster opportunity for GSK, which hoped to add camlipixant to a portfolio of respiratory drugs that includes asthma and COPD treatments like Trelegy and Anoro. The company said it is continuing Phase 2 trials in people with irritable bowel syndrome.
    • “Camlipixant’s failure follows that of two others in the “P2X3 antagonist” class that were developed by Bayer and Merck & Co, the latter of which spent more than $500 million to gain control of its drug. The setback also clears away a threat to Trevi Therapeutics, which is advancing a different type of treatment in chronic cough.”
  • and
    • “Merck & Co.’s partner Kelun-Biotech said its experimental medicine sac-TMT helped patients with a form of lung cancer stave off disease progression better than a standard regimen including chemotherapy in a new Phase 3 study.
    • “The trial, conducted in China, included patients with locally advanced or metastastic non-squamous non-small cell lung cancer whose tumor cells don’t have enough of a protein called PD-L1. When working properly, PD-L1 helps the immune system focus on killing diseased cells instead of healthy ones. But too much or too little of this protein can throw the system off kilter.
    • “Kelun previously saw success with sac-TMT in PD-L1-positive patients and is now tackling the “negative” patients who represent what it calls a “therapeutic bottleneck.” Sac-TMT is the first so-called antibody drug conjugate to succeed in a Phase 3 study of this patient population in combination with an immunotherapy like Keytruda, Kelun said Tuesday [July 14].”

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

  • Beckers Hospital Review reports,
    • “Vascular surgery is projected to have the highest shortages of physicians, the Health Resources and Services Administration’s National Center for Health Workforce Analysis found.
    • “The HRSA workforce simulation model assesses the adequacy of the nation’s projected workforce supply for 35 physician specialties from 2023 through 2038.
    • “Across all specialties, there is a projected shortage of 141,160 full-time equivalent physicians by 2038. Only five of the 35 physician specialties are expected to see a surplus of workers. The shortages in some specialties can be mitigated by increasing the use of nurse practitioners and physician assistants, according to the center.”
  • and 
    • “Novant Health is the latest health system to launch round-the-clock virtual primary care that uses AI to assess patients before connecting them with a clinician, joining at least seven other systems offering similar 24/7 care models.”
    • The article lists seven other health systems using this model.
  • and
    • The pandemic revealed a demand for telehealth, forcing the healthcare industry to rethink how and where care could be delivered. 
    • Patients and providers alike discovered that high-quality care doesn’t have to mean an in-person visit. Hospitals, health systems and healthcare companies rapidly expanded their telehealth offerings accordingly.
    • The momentum hasn’t slowed, and today’s telehealth landscape is defined by smarter platforms, broader access and solutions designed to bring expert care directly to patients regardless of geography, mobility, or circumstance. 
    • [The article lists] 272 telehealth companies to know. 
  • STAT News relates,
    • “Every day, doctors turn to specialized calculators to make decisions about their patients’ care. Kidney performance? There’s a calculator for that. Chance of a successful vaginal birth after a previous C-section? There’s a calculator for that. 
    • “Medicine has accumulated hundreds of these clinical scores and decision-making tools, and their numbers continue to grow along with the scale of clinical data. But just because a calculator exists doesn’t mean doctors should always trust its output. 
    • “In clinical practice, a lot of the tools that we use, we genuinely have no idea how limited it is in its validation,” said health systems researcher and gastroenterologist Shazia Siddique. That is why MDCalc, the company Siddique joined last year, is launching a quality-rating system to apply to the more than 800 clinical tools and calculators that doctors use through its site.”
  • Per Fierce Pharma,
    • “Following the Independence Day holiday, the overall GLP-1 market was down 5.1% week over week as measured by total prescriptions across obesity and diabetes uses, according to IQVIA data cited by Citi.
    • “In the obesity field specifically, total scripts for Eli Lilly’s Zepbound shrank by 3.1% sequentially to a little below 660K, while Novo Nordisk’s Wegovy dipped 4.4% to about 448.5K.
    • “Against this backdrop, Lilly’s oral Foundayo seemed to enjoy a small inflection point, with a total 24,303 scripts notably breaking away from its roughly 20K level in the prior five weeks.  
    • “Meanwhile, joining the bigger trend, Wegovy pill scripts dropped to 147.5K during the week, versus about 153K the prior week or 161.5K at its peak. But the contribution of the oral version to the overall Wegovy scripts remained stable at around a third, per Citi’s note.” 
  • Per BioPharma Dive,
    • “Cash-strapped biotechnology company Jasper Therapeutics has gained a financial lifeline through a merger with a privately held immune drug developer.
    • “Jasper said Thursday it has completed an all-stock acquisition of Kira Pharmaceuticals and, alongside that deal, raised $132 million in a private stock offering. The new funding will enable Jasper, which had just $14 million in cash at the end of March, to operate through the second half of 2028. The combined company will retain the Jasper stock ticker, but have a bigger pipeline that now includes two immune disease drugs Kira has been developing.”