FEHBlog

Weekend update

David Ermer–Congress, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Roll Call shares its insights into this week’s upcoming Congressional work.
  • The Washington Stand reports that Scott Kupor will be sworn in as the 27th U.S. Office of Personnel Management Director tomorrow, July 14.

From the public health and medical research,

  • The Washington Post tells us “What to know about the pneumonic plague after Arizona patient’s death. A person died in Flagstaff [,Arizona,] of the rare illness related to the bubonic plague. Once called the “Black Death,” plague is now curable in all its forms if treated quickly.”
  • Per Medscape,
    • “In a cohort of 157,332 in the Veterans Health Administration with atrial fibrillation (AF), Black patients had a 14% higher risk for stroke than White patients, but Black, Asian, and Hispanic patients were less likely than White patients to die from stroke.”
  • Medscape also discusses a new joint advisory from “the American College of Lifestyle Medicine, the American Society for Nutrition, the Obesity Medicine Association, and The Obesity Society” that offers the first consensus in prescribing GLP-1s and lets us know,
    • “With a GLP-1 in pill form for weight loss expected to be FDA-approved by year’s end, obesity medicine physicians said they are gearing up for higher demand and already answering questions about the anticipated new option.
    • “Predictions are mixed about how many people may dump the shots in favor of the pill, and some physicians worry about misuse, mostly patients skipping or double dosing. While doctors welcome the new option, many also pointed to a host of other medications in the pipeline that they say look as good or better than the anticipated new pill.”

From the U.S. healthcare business front,

  • Gen Edge lists the top ten best selling drugs.
    • “GEN’s updated A-List of the top 10 best-selling prescription drugs based on 2024 sales * * * are ranked based on sales or revenue reported for 2024 by biopharma companies in press announcements, annual reports, investor materials, and/or conference calls. Each drug is listed by name, sponsor(s), 2024 sales, 2023 sales, and the percentage change between those years.
    • “The total 2024 aggregate value of the top 10 best-selling drugs was $154.888 billion, up 6.5% from $145.495 billion in 2023—and up 53% over five years from the $101.15 billion generated in 2019, as highlighted by GEN.”
  • BioPharma Dive reports,
    • “Merck & Co.’s $10 billion acquisition of Verona Pharma Wednesday is a dramatic outcome for a company that’s spent 20 years developing a respiratory drug it now sells as Ohtuvayre. The treatment has been in testing so long its principal patent expired before former President Joe Biden took office.
    • “If Merck and Wall Street’s forecasts of blockbuster sales for Ohtuvayre prove accurate, the drug will be yet another demonstration of how aggressive patenting can help drugmakers turn compounds invented long ago into billions of dollars in revenue.” * * *
    • “For Merck, revenue from Ohtuvayre would help offset at least some of the financial losses when patents for Keytruda, its top-selling cancer immunotherapy, expire later this decade. Concerns about Merck’s post-Keytruda future have caused a double-digit share slide this year, and Ohtuvayre adds “diversification away from Keytruda,” wrote Jefferies analyst Akash Tewari in a separate investor note. 
    • “Meanwhile, research Verona already has underway could help extend the Ohtuvayre life cycle beyond existing patents. The company is studying in Phase 2 trials preparations for dry powder and pressurized “metered dose” inhalers, which could allow it to establish additional formulation or device patents.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “The tax and spending bill Congress sent to President Donald Trump and that he signed into law over the holiday weekend [the One Big Beautiful Act] contains hundreds of millions of dollars for cybersecurity, with a heavy emphasis on military-related spending.
    • “The biggest single pot of money under the “One Big Beautiful Bill” would be for Cyber Command, a $250 million allocation for “artificial intelligence lines of effort.” Another $20 million would go to cybersecurity programs at the Defense Advanced Research Projects Agency.
    • “The U.S. Indo-Pacific Command — which counts among its geographical areas of responsibility territorial waters for cyber adversaries in Russia, China and North Korea — would get $1 million for cyber offensive operations. Cyber offense was something the second Trump administration emphasized when coming into office.”
  • Cybersecurity Dive adds,
    • Congress must reauthorize a cybersecurity threat information sharing law before it expires in October, a group of leading technology companies told lawmakers on Monday.
    • The 2015 Cybersecurity Information Sharing Act “has enabled rapid dissemination of actionable threat intelligence to protect networks before an incident occurs, more coordinated responses to cyber incidents; and improved situational awareness across multiple sectors,” the Hacking Policy Council said in a letter to House and Senate homeland-security committee leaders.
    • “The council’s members include tech giants Google, Microsoft and Intel; security firm Trend Micro; and bug bounty platforms Bugcrowd, HackerOne and Intigriti. The group advocates for policies that improve vulnerability management, security research and penetration testing.
    • “The CISA law, which offers legal protections for companies that share threat information, is set to expire on Sept. 30. There is bipartisan support on Capitol Hill for renewing the law, but lingering questions could complicate its prospects, including whether any lawmakers will press for changes to the program and whether the reauthorization will be attached to a larger must-pass bill or proceed on its own.”
  • The Government Accountability Office released a positive report about the 2015 Cybersecurity Information Sharing Act earlier this week.
  • Per Cybersecurity Dive,
    • “The Securities and Exchange Commission has reached a settlement with SolarWinds and the company’s chief information security officer, Timothy Brown, to resolve charges stemming from the Russian-backed cyberattack on the company’s systems.
    • “The parties “have reached a settlement in principle that would completely resolve this litigation,” the SEC said in a filing last week with the federal judge in New York who is overseeing the commission’s lawsuit against the company.
    • ‘The judge quickly approved the SEC’s request to stay deadlines in the case, including oral arguments previously scheduled for July 22. “The Court congratulates counsel and the parties on this productive development,” the judge said. He gave SolarWinds, Brown and the SEC until Sept. 12 to either file settlement paperwork or provide a status update on the settlement process.” * * *
    • “Adam Hickey, a partner at Mayer Brown and a former federal prosecutor handling cyber and national security cases, said an examination of the eventual settlement terms would reveal “whether and to what extent the SEC is abandoning certain theories or allegations.”
    • “So far, the SEC has not moved to rescind the rule requiring cybersecurity disclosures in annual and periodic reports,” he said. “The settlement may or may not point in that direction.”
  • Per an HHS news release,
    • “Today [July 7, 2025], the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Deer Oaks – The Behavioral Health Solution (Deer Oaks), a behavioral health provider, resolving potential violations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. Deer Oaks provides psychological and psychiatric services to residents of long-term care and assisted living facilities.” * * *
    • The settlement principally related to an August 2023 ransomware attack that affected 171,000 patients.
    • “Under the terms of the resolution agreement, Deer Oaks agreed to implement a corrective action plan that OCR will monitor for two years and paid $225,000 to OCR.” * * *
    • The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/sites/default/files/ocr-hipaa-racap-deer-oaks.pdf [PDF, 183 KB]
  • Cybersecurity Dive informs us,
    • “Italian authorities and FBI agents have arrested a Chinese man who allegedly helped Beijing’s Hafnium group conduct a series of high-profile cyberattacks in 2020 and 2021.
    • “Xu Zewei, 33, faces charges of hacking into the computers of U.S. researchers studying the COVID-19 virus and exploiting vulnerabilities in Microsoft Exchange servers that kicked off a global attack spree. The Justice Department announced his indictment and arrest on Tuesday, [July 8,] along with charges against another Chinese man, 44-year-old Zhang Yu, who remains at large.
    • “Both men carried out the attacks on behalf of China’s Ministry of State Security, prosecutors alleged.”
  • Per Cyberscoop,
    • “At the request of the United States, French police arrested a professional Russian basketball player who had a brief tenure at Penn State over accusations that he was part of a ransomware ring, according to overseas reports.
    • “News of the arrest of Daniil Kasatkin came in a court in Paris on Wednesday [July 9]. His lawyer denied to foreign press that he was part of any ransomware ring. * * *
    • “Kasatkin is allegedly part of a hacking outfit that the news outlets did not name, but that American investigators believe has attacked 900 institutions, including two U.S. federal entities, between 2020 and 2022. Authorities said he negotiated ransomware payments on behalf of the ring.”
  • and
    • “Three teenagers and a 20-year-old woman were arrested Thursday by the U.K.’s National Crime Agency for their alleged role in cyberattacks on major retailers Marks & Spencer (M&S), Co-op, and Harrods.
    • “The arrests, comprising British and Latvian nationals, followed sustained investigations into attacks that crippled the retailers’ operations. The NCA’s National Cyber Crime Unit detained all four at their homes and seized their electronic devices.” * * *
    • “The particular incidents that led to these arrests occurred in April, with attackers crippling the online services of Marks & Spencer, a popular retailer in the U.K. The company’s online sales channels were halted, contactless payments and click-and-collect options were disrupted, and in-store product availability suffered. The attack also resulted in the theft of customer information, including names, email addresses, and postal data. Recovery efforts began in June, with the retailer eventually restoring sections of its online business across the U.K.”

From the cybersecurity breaches and vulnerabilities front,

  • Radiology Business reports,
    • “A PET imaging provider was recently impacted by a phishing attack, forcing the company to notify patients about the breach. 
    • “Nashville, Tennessee-based Integrated Oncology Network alerted Health and Human Services in late June about the hacking incident, which occurred in December. Affected locations include PET Imaging of Tulsa, Oklahoma, and similarly branded centers in cities such as Houston, Dallas and Sugar Land, Texas. 
    • “Information accessed by third parties may have included dates of birth, diagnoses, financial account info and (“for a small number of individuals”) Social Security numbers.” * * *
    • “The network notified physicians about the phishing attack on June 13 and started alerting customers on June 27. This after a May investigation determined there was unauthorized access to patient information in a “small number” of email and SharePoint accounts. ION is urging patients to review their statements from providers and insurance plans to see if they find any inconsistencies. It’s also providing additional cybersecurity training to staffers, according to the notice. 
    • “Schubert Jonckheer & Kolbe sent a news alert on July 9, with the law firm launching an investigation into the cyber incident. It estimated that nearly 114,000 individuals may have been affected, with the firm now considering filing a suit against Integrated Oncology Network.”
  • Cybersecurity Dive adds,
    • “Mobile phishing scams are becoming an increasingly serious threat, but companies aren’t taking that threat seriously enough, the mobile security firm Lookout said in a report released Thursday.
    • “Nearly six in 10 companies “have experienced incidents due to executive impersonation scams via text or voice” and 77% have experienced at least one such attack in the past six months, Lookout said in the report. Yet despite the pervasiveness of these attacks, “only half of respondents are very concerned” about the threat, the report found.
    • “The findings — based on a survey of more than 700 security leaders — reflect “a dangerous situation that leaves businesses overconfident and more vulnerable to modern threats than they realize,” Lookout said.
    • “Hackers are increasingly relying on mobile voice and text phishing messages to trick workers into handing over their passwords, granting attackers access to computer networks through legitimate accounts that raise fewer red flags on security monitoring platforms.”
  • and
    • “Hackers linked to the Iranian government have escalated attacks against certain U.S. critical infrastructure since the beginning of the Israel-Iran conflict, according to new research.
    • “The Iran-linked threat groups, tracked as MuddyWater, APT33, OilRig, CyberAv3ngers, FoxKitten and Homeland Justice, tried to breach at least 10 U.S. companies, mostly in the transportation and manufacturing sectors, researchers at Nozomi Networks said on Wednesday.
    • “MuddyWater targeted five firms, APT33 targeted three and the others targeted two, according to the research.”
  • The Cybersecurity and Infrastructure Security Agency added five known exploited vulnerabilities to its catalog this week.
    • July 7, 2025
      • CVE-2014-3931 Multi-Router Looking Glass (MRLG) Buffer Overflow Vulnerability
      • CVE-2016-10033 PHPMailer Command Injection Vulnerability
      • CVE-2019-5418 Rails Ruby on Rails Path Traversal Vulnerability
      • CVE-2019-9621 Synacor Zimbra Collaboration Suite (ZCS) Server-Side Request Forgery (SSRF) Vulnerability
        • SC Media discusses these KVEs here.
          • “What made these four bugs of special note were that two date back to 2019, one to 2016, and the fourth was first identified in 2014, underscoring that security teams have to keep tabs on all bugs and continually monitor and stay up-to-date with patching. Two of the four were rated critical.
    • July 10, 2025
      • CVE-2025-5777 Citrix NetScaler ADC and Gateway Out-of-Bounds Read Vulnerability.
        • Cybersecurity Dive and Bleeping Computer discuss this KVE.
          • “[CISA] has confirmed active exploitation of the CitrixBleed 2 vulnerability (CVE-2025-5777) in Citrix NetScaler ADC and Gateway and is giving federal agencies one day to apply fixes.
          • “Such a short deadline for installing the patches is unprecedented since CISA released the Known Exploited Vulnerabilities (KEV) catalog, showing the severity of the attacks exploiting the security issue.
          • “The agency added the flaw to its Known Exploited Vulnerabilities (KEV) catalog yesterday, ordering federal agencies to implement mitigations by the end of today, June 11.”
  • Per SC Media,
    • “A newly disclosed infostealer dubbed “NordDragonScan” executes stealthily on Windows machines using living-off-the-land (LOTL) techniques, Fortinet reports.  
    • “The attack kicks off when users visit a site called secfileshare[.]com, which downloads a RAR archive designed to look like a Ukrainian government document, Fortinet’s FortiGuard Labs Threat Research unit described in a blog post Monday.
    • “A LNK shortcut within the archive invokes the Windows utility mshta.exe to retrieve and execute an HTML Application (HTA) script from the secfileshare[.]com domain, called 1.hta.
    • “This HTA copies the legitimate PowerShell.exe binary to the Documents folder and renames to install.exe to hide its activity. It then downloads a benign decoy document, tricking the victim into believing this is the file they installed while the malicious payload runs in the background.”

From the ransomware front,

  • Dark Reading warns,
    • “Changes are afoot at Pay2Key, a ransomware-as-a-service (RaaS) gang with ties to a notorious Iranian nation-state threat group, and it could spell trouble for the US.
    • “Pay2Key was first observed in 2020, and while it has been one of the lesser-known RaaS gangs, it achieved some notoriety for hack-and-leak attacks on Israeli organizations. Over the years, cybersecurity vendors and US authorities alike have tied the gang to Fox Kitten, an Iranian state-sponsored threat group also known as UNC757.
    • “Now, researchers at Morphisec say Pay2Key has re-emerged with a new approach: targeting Western organizations and offering higher payouts for attacks that meet the gang’s geopolitical goals in the wake of Israel-Iran-US conflict. According to a new report from Morphisec Labs researchers, the gang has raised its affiliate profit-sharing from 70% to 80% for attacks against “the enemies of Iran.”
  • CSO offers us an “anatomy of a Scattered Spider attack: A growing ransomware threat that evolves.”

From the cybersecurity threat research front,

  • Cyberscoop reports,
    • “Cybersecurity researchers have identified four significant security vulnerabilities in a widely used automotive Bluetooth system that could potentially allow remote attackers to execute code on millions of vehicles worldwide.
    • “The vulnerabilities, collectively named PerfektBlue by PCA Cyber Security, affect OpenSynergy’s BlueSDK Bluetooth stack, which is used to implement Bluetooth functionality in embedded systems, with a strong emphasis on automotive applications. The vulnerabilities impact technology used in Mercedes-Benz, Volkswagen, and Skoda automobiles. A fourth manufacturer, which researchers have not publicly identified, is also confirmed to use the affected technology.
    • “The discovery highlights the expanding attack surface in modern connected vehicles, where Bluetooth-enabled infotainment systems have become standard equipment. The researchers found that the four vulnerabilities can be linked together in an exploit chain, potentially allowing attackers to gain unauthorized access to vehicle systems through Bluetooth connections.”
  • Dark Reading adds,
    • “Systemic vulnerabilities in embedded Subscriber Identity Module (eSIM) cards have exposed billions of devices to spying, SIM swaps, and other threats.
    • “For some time now, traditional SIM cards have been slowly ceding to eSIMs. eSIMs allow multiple phone carrier subscriptions to exist on a single device. Unlike traditional SIM cards, you can’t physically remove and replace them, and they tout superior security.
    • “New research suggests, though, that they actually introduce significant security risks. Using a Kigen embedded Universal Integrated Circuit Card (eUICC) card, Adam Gowdiak, founder and CEO of Security Explorations, found that attackers could theoretically breach eSIMs to spy on their users, manipulate their services, and steal valuable information from mobile network operators(MNOs).”
  • Bleeping Computer notes,
    • “A novel tapjacking technique can exploit user interface animations to bypass Android’s permission system and allow access to sensitive data or trick users into performing destructive actions, such as wiping the device.
    • “Unlike traditional, overlay-based tapjacking, TapTrap attacks work even with zero-permission apps to launch a harmless transparent activity on top of a malicious one, a behavior that remains unmitigated in Android 15 and 16.
    • “TapTrap was developed by a team of security researchers at TU Wien and the University of Bayreuth (Philipp Beer, Marco Squarcina, Sebastian Roth, Martina Lindorfer), and will be presented next month at the USENIX Security Symposium.”
  • and
    • “NVIDIA is warning users to activate System Level Error-Correcting Code  mitigation to protect against Rowhammer attacks on graphical processors with GDDR6 memory.
    • “The company is reinforcing the recommendation as new research published by the University of Toronto demonstrates the practicallity of Rowhammer attacks against an NVIDIA A6000 GPU (graphical processing unit).
    • “We ran GPUHammer on an NVIDIA RTX A6000 (48 GB GDDR6) across four DRAM banks and observed 8 distinct single-bit flips, and bit-flips across all tested banks,” describe the researchers.’

From the cybersecurity defenses front,

  • Dark Reading reports,
    • The cyber-insurance market continues to generate profits for underwriters, but competition in the market and softening demand has led to a decline in the total revenue from premiums for the third straight year in a row — a situation that could work in businesses’ favor.
    • Overall, cyber-insurance experts expect premiums to continue to decline in 2025 and likely level off next year, as market economics balance supply and demand. Renewal rates for cyber-insurance policies have declined each quarter for the last three quarters, which is expected to continue, according to credit and economic firm Fitch Ratings.
    • “As businesses shop around for better rates on cyber coverage — or take a pause to reassess — insurers continue to lower rates by mid- to low-single-digit percentages, says Gerry Glombicki, senior director at Fitch Ratings.
    • “Historically, cyber insurance has been pretty profitable — even with 2017” and the damage from WannaCry and NotPetya, he says. “Now, the number of policies they’re selling is down year-over-year, and their pricing is down … because the returns that the insurers have [historically] gotten have been good, so they have to give up some of that.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • STAT News reports,
    • “Republicans’ first major policy bill this year was a partisan affair: They cut Medicaid funding by some $1 trillion to help fund tax cuts prized by President Trump.
    • “Now, though, there are some bipartisan health care policies, from pharmacy-benefit manager reform to Medicare doctor payment changes, that the two parties could work on — and many health care programs with bipartisan support that are set to expire this year if lawmakers don’t act. 
    • “The Food and Drug Administration’s user fee program for over-the-counter drugs also expires this year.
    • “The reason that some of these health care measures get tacked onto appropriations bills is that the government has to be funded, or it will shut down. Passing government-spending legislation requires 60 votes, so it takes support from both parties. 
    • “Congress typically uses annual appropriations bills to renew many health care programs and policies in Medicare and Medicaid, collectively called health care extenders. Well over a dozen expire or run out of cash after Sept. 30, including a popular Medicare program that makes telehealth services widely available, and funding for community health centers, hospitals that care for large numbers of uninsured, and certain pandemic preparedness activities. 
    • But Democrats are signaling they may not work with Republicans on this process. * * *
    • “Senate Minority Leader Chuck Schumer (D-N.Y.) warned of precisely that scenario on Tuesday, saying that Republicans would poison any remaining relationship with Democrats if they vote for the rescissions bill.
    • “Plus, some key Republican lawmakers have raised the idea of pursuing another budget reconciliation bill — the same partisan pathway they used to extend Trump’s tax cuts.” 
  • Time will tell, but here are a couple of examples of bipartisan bills.
  • The American Hospital Association News tells us,
    • “A bill was introduced July 10 to extend certain Medicare waivers authorizing the hospital-at-home care program. The bill was introduced in the House by Reps. Vern Buchanan, R-Fla., Lloyd Smucker, R-Pa., and Dwight Evans D-Pa., and in the Senate by Sens. Tim Scott, R-S.C., and Rev. Raphael Warnock, D-Ga.”
  • Per a Congressional news release,
    • Rep. Earl L. “Buddy” Carter (R-GA) today led 11 bipartisan members of Congress in introducing the PBM Reform Act, which protects patients and pharmacies from the harmful and anticompetitive business practices of pharmacy benefit managers (PBM). * * *
    • Read the full text here.
  • MedTech Dive tells us,
    • “The Centers for Medicare and Medicaid Services has agreed to cover transcatheter edge-to-edge repair for tricuspid valve regurgitation, including Abbott’s TriClip system.
    • “In a LinkedIn post, Abbott called the national coverage determination a milestone for patients with severe tricuspid regurgitation that will support broader access to a minimally invasive treatment for those who are not good candidates for surgery.
    • “This decision helps open the door to treatment for more people living with symptomatic severe tricuspid regurgitation – many of whom have had few options in the past. It also provides additional clarity for care teams working to bring minimally invasive solutions to these complex patients,” Sandra Lesenfants, senior vice president of Abbott’s structural heart division, said on LinkedIn.”
  • and
    • “The Centers for Medicare and Medicaid Services on Thursday posted a proposed national coverage determination for renal denervation, a new procedure for lowering blood pressure in people with uncontrolled hypertension.
    • “Medtronic and Recor Medical, a subsidiary of Otsuka Medical Devices, obtained Food and Drug Administration approval for the first-of-a-kind treatments in late 2023, with Medtronic’s Symplicity Spyral device overcoming resistance from an advisory panel of outside experts to ultimately win the FDA’s backing.
    • “William Blair analyst Brandon Vazquez said a CMS national coverage decision for renal denervation could pave the way for the treatment to become “one of the largest growth drivers in recent history” for Medtronic, noting the device maker has estimated more than 18 million people in the U.S. have high blood pressure that is not well managed with medication and lifestyle changes. “While this is only a proposed rule, we view the positive readout as a meaningful first step toward Symplicity’s ramp-up,” Vazquez wrote in a report to clients Friday.”

From the judicial front,

  • Bloomberg Law reports,
    • “MSN Laboratories Ltd. can sell its copies of Novartis AG’s Entresto upon FDA approval after a federal judge found they don’t infringe a key patent for the heart-failure drug.
    • :MSN’s proposed generics don’t infringe Novartis’ US Patent No. 11,096,918, Judge Richard G. Andrews ruled in an opinion issued Friday in the US District Court for the District of Delaware. He also denied Novartis’ related request to prevent MSN from launching during any appeal.
    • “MSN’s tablets don’t contain the crystalline sacubitril-valsartan compound described in the ‘918 patent, Andrews said, so they don’t infringe. The ruling followed a December 2024 bench trial focused solely on infringement. Novartis warned in a status update earlier Friday that MSN could receive final approval from the US Food and Drug Administration as soon as July 16. Entresto’s pediatric exclusivity expires July 15.
    • “A Novartis spokesperson said the company “is disappointed with the decision” and plans to appeal it. “Novartis is confident in our intellectual property and regulatory rights related to Entresto and will continue to defend our rights,” the statement said. “There are currently no generic versions of Entresto available in the US.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza and COVID-19 activity is low. RSV activity is very low.
    • “COVID-19
      • “COVID-19 wastewater activity and laboratory percent positivity are low nationally. Emergency department visits for COVID-19 are very low but increasing. Model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in many Southeast, Southern, and West Coast states.
    • Influenza
    • RSV
      • “RSV activity is very low.”
  • Newsweek reports,
    • “A nationwide recall of chocolate products has been issued the highest risk warning by the U.S. Food and Drug Administration (FDA).
    • “Weaver Nut Company, Inc., based in Pennsylvania, announced a voluntary recall for specific lots of its semi-sweet chocolate nonpareils on June 17 due to the possible undeclared presence of milk, a major food allergen.
    • “The FDA subsequently issued a Class 1 risk classification for the recall on July 8.” * * *
    • “The recall was initiated due to the undeclared presence of milk, one of the nine major food allergens as defined in law. The others are eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.”
  • Beckers Clinical Leadership lets us know,
    • “Three cities in Texas have the highest percentage of adults with fair or poor health, according to WalletHub’s annual ranking, published July 7.
    • “To determine the ranking, WalletHub compared 182 cities across four dimensions — work stress, financial stress, family stress, and health and safety stress — and evaluated those dimensions using 39 weighted metrics. Each metric was graded on a 100-point scale, with a score of 100 representing the highest levels of stress.”
  • Per Beckers Payer Issues,
    • “A virtual diabetes management program offered by UnitedHealthcare has shown measurable changes in members’ behavior, and for some employers, a return on investment.
    • “The Level2 program, originally launched under Optum in 2019, combines continuous glucose monitors, personalized coaching, and a virtual care model. It targets employees with type 2 diabetes and aims to improve clinical outcomes through self-management and simplified access to care.
    • “A lot of the cost for diabetes is with the highest-risk patients, so we had our physicians and team focus on how to engage more patients that are high-risk,” David Moen, MD, a physician executive at Level2, told Becker’s. 
    • “In a June study published by the American Diabetes Association, UnitedHealth researchers analyzed 3,773 Level2 Specialty Care participants with at least 180 days of CGM usage between January 2023 and June 2024. The patients used the CGM for an average of 83.6% of days, and 82% of them logged actions in the Level2 app. The most common types of actions were related to nutrition (36%) and movement (33%), followed by tracking (19%), mindfulness (9%), and treatments such as medications or talking to a physician (1%).”
  • STAT News discusses a bionic knee that MIT researchers are now testing on human subjects.
    • The study involved putting three groups of volunteers with above-the-knee amputations through tests that included climbing stairs, standing without a handrail, and avoiding a foam block obstacle when walking on a treadmill. One group, which served as a control, used the bionic knee without any other interventions.
    • “The two other groups underwent a surgical procedure developed by Herr and Dr. Matthew Carty of Brigham and Women’s Hospital that reconnects pairs of muscles that are typically severed during amputation. The muscles take turns stretching and contracting, conveying sensory information to the brain. The surgery, known as agonist-antagonist myoneural interface, or AMI, allows amputees to regain a push-and-pull dynamic in their leg muscles so they have a vivid feeling of their phantom joint moving around.
    • “[The article’s protagonist Thomas] Gee was in the only group to have the prosthesis fully integrated in their bodies, with electrode wires from the prosthesis to their thigh muscles. The other two groups used electrodes attached to the skin surface of their amputated legs to the prosthesis to collect information about electrical activity of the leg muscles.
    • “The study found that patients who were using the bionic knee with electrodes implanted within their muscles could complete the tasks more accurately and with a greater sense the prosthesis was part of their bodies.”

From the U.S. healthcare business front,

  • Managed Healthcare Executive reports,
    • “Commercial insurers pay hospitals much more than Medicare in some areas than others, and a new study found that local market factors, including hospital dominance, help explain these growing price gaps.
    • “These findings, published in JAMA Health Forum, could help guide future efforts to control rising healthcare costs.
    • “From 2000 to 2020, medical care prices in the U.S. rose nearly twice as fast as prices for other goods and services—growing at an average of 4.9% per year, compared to 2.5%. Hospital services saw even steeper increases, averaging 10.2% annually.
    • “While price growth slowed during the COVID-19 pandemic, the study showed that federal projections expect it will return to previous levels and continue outpacing the rest of the economy through 2032.
    • “Another analysis from KFF and the Peterson Center on Healthcare found that overall health spending rose 7.5% from 2022 to 2023 and is expected to rise another 4.2% in 2025. Key drivers include high-cost drugs, federal funding cuts, and workforce shortages—factors expected to remain central to the policy debate in 2025.”
  • Per Beckers Hospital Review,
    • Becker’s is pleased to release the 2025 edition of its “Great community hospitals” list.
    • Community hospitals play a vital role in the fabric of the U.S. healthcare system, delivering accessible, affordable care to patients beyond major metropolitan areas. Whether serving rural regions or suburban neighborhoods, these hospitals are essential to keeping communities healthy and connected to quality care.
    • The community hospitals recognized on this list are dedicated to clinical excellence, academic advancement and personalized, whole-person care delivery. Their mission is to elevate health outcomes within the communities they serve. 
  • and
    • “Forty-one hospitals have converted to rural emergency status since the designation took effect in 2023. 
    • “Under the designation, hospitals end inpatient services and instead offer emergency, observation and other outpatient services.
    • “While providing an opportunity to preserve critical healthcare services in rural communities, it is also offering a path to revive hospitals that have closed, Kaufman Hall said in a July 10 report. The healthcare consulting firm noted that three hospitals that have closed in recent years are eyeing a return as rural emergency facilities. 
    • “The fact that several of these announcements involve the reopening of closed hospitals — albeit in a different form — is a promising sign that different ways of thinking about rural healthcare could help maintain or restore access to essential services and enable a vehicle for such transformation,” Kaufman Hall said. “This trend also suggests that the partners in these transactions believe that there is a viable path forward for rural healthcare.”
  • and
    • “While the total number of drug shortages in the U.S. appears to be decreasing in 2025, some shortages of essential medications have yet to be resolved. 
    • “Erin Fox, PharmD, senior pharmacy director at University of Utah Health, said a few persistent shortages continue to strain health systems, especially certain drugs essential to emergency, surgical and outpatient care. 
    • “There are a number of ongoing shortages. But a few of them are ongoing or are becoming worse, so they are definitely top of mind,” she said. 
    • “Here are four high-impact shortages Dr. Fox said her team is focused on for the rest of 2025.”
      • Lorazepam injection 
      • Injectable steroids
      • IV fluids, and
      • Generic injectables.
  • Fierce Healthcare reports,
    • Walgreens Boots Alliance shareholders have voted to approve the company’s sale to Sycamore Partners.
    • The pharmacy giant announced Friday morning that 96% of the shareholder votes at a special meeting favored the merger, which would take Walgreens private, according to preliminary results. That includes 95% of unaffiliated shareholders voting for the deal.
    • “Under the terms announced earlier this year, stakeholders will receive $11.45 in cash per share, for a total deal value of about $10 billion.
    • “The company expects the sale will close in the third or fourth quarter of 2025, per the announcement.”
  • Healthcare Dive informs us,
    • “Genesis Healthcare, one of the largest providers of skilled nursing facilities in the country, filed for Chapter 11 bankruptcy protections on Wednesday.
    • “Pennsylvania-based Genesis, which operated about 175 skilled nursing facilities across 18 states at its filing, said it struggled with post-pandemic challenges, legacy liabilities and inadequate Medicaid reimbursement. Staff will retain their positions, and the filing is not expected to impact patient care, a Genesis spokesperson told Healthcare Dive.
    • “Affiliates of Genesis’ investor ReGen Healthcare, a private equity firm, have entered into a deal to acquire Genesis, according to bankruptcy court documents filed Thursday.”

Thursday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, SCOTUS, SDOH, U.S. Healthcare–

From Washington, DC,

  • On July 2, 2025, the U.S. Office of Personnel Management’s Inspector General issued a Flash Report titled “OPM’s Postal Service Health Benefits Program: Critical Resource Issues,” which Govexec discusses here. The FEHBlog believes and has repeatedly stated that the eligibility program for FEHB and PSHB could be vastly improved if OPM used the widely adopted HIPAA 820 Electronic Enrollment Roster Transaction. The HIPAA 820 transaction would allow carriers to promptly and systematically identify situations where no, or an incorrect, premium payments.
  • The American Hospital Association News reports,
    • Senior leaders from the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, along with White House representatives, visited pharmaceutical company Phlow Corp.’s new production system that manufactures key starting materials, active pharmaceutical ingredients and finished dose forms for 15 medicines used in the U.S. health system. Phlow laboratories and manufacturing facilities are located in the Mid-Atlantic, keeping the complete manufacturing cycle contained in one region. HHS-ASPR and Phlow have collaborated since May 2020 to bring pharmaceutical supply chains into the U.S. and reduce dependency on foreign countries. China and India, for example, account for more than 70% of APIs and KSMs imported to the United States. 
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today unveiled its groundbreaking Functional Repair of Neocortical Tissue (FRONT) program, a transformative initiative to restore brain function and position the U.S. as the global leader in brain repair technology. The FRONT program aligns directly with the priorities set by President Trump and Secretary Robert F. Kennedy, Jr., demonstrating a strong commitment to innovation, public health, and the economic well-being of the American people.
    • “Millions of Americans are living with the damage caused by strokes and traumatic brain injuries. Current treatments are not enough. ARPA-H hopes to deploy regenerative medicine to transform the treatment of neurological diseases and relieve the suffering,” said HHS Deputy Secretary Jim O’Neill.
    • ‘The neocortex, the largest part of the brain, is critical for sensory perception, motor control, and decision-making. Damage to this area—due to conditions like stroke, traumatic injury, or neurodegeneration, such as Alzheimer’s disease—has long led to irreversible damage, leaving individuals dependent on costly therapies or caregivers. The FRONT program aims to change that, using cutting-edge neurodevelopmental principles and stem cell technology to regenerate brain tissue and restore lost functions.”
  • The Brown & Brown actuarial consulting firm helpfully summarizes here the employee benefit provisions of the One Big Beautiful Act.
  • CMS announced resources and flexibilities to address the public health emergency in the State of Texas.

From the judicial front,

  • Govexec reports,
    • “The federal judge who temporarily blocked the Trump administration from implementing mass layoffs before the Supreme Court intervened has suggested she still plans to litigate the legality of individual agency workforce reduction plans. 
    • “The high court this week struck down the injunction that impacted most major agencies, allowing the administration to move forward with widespread RIFs. New layoff notices have not gone out since that decision on Tuesday, but they are expected imminently at several agencies. The court made clear, however, that its ruling applied only to the overall finding of President Trump’s capacity to order staffing cuts and not to the legality of individual agency RIF plans. 
    • “The content of those individual plans “thus remains squarely at issue in this case,” California-based U.S. District Judge Susan Illston, whose original decision led to the RIF pause, said in a new order Wednesday evening.” * * *
    • “Attorneys for the Trump administration previously noted it had 40 RIF actions underway at 17 agencies that were paused by Illston’s injunction. The federal employee unions, local governments and non-profit organizations that originally brought the lawsuit issued an “urgent request” following the Supreme Court decision asking the administration to submit those plans to the court for a decision on their legality. Illston ordered the administration to reply to that request by Monday and suggested she agreed the plans should be submitted for examination. 
    • “The administration previously argued it could not release them because they were predecisional and subject to executive privilege, but the judge on Wednesday suggested that final decisions on the RIFs must have been made if her injunction had paused them from taking effect. She added the court was “not inclined” to allow for significant redactions.” 
    • Here is a Dropbox link to the Court’s order.
  • The New York Times adds,
    • “A federal judge on Thursday blocked the Trump administration from enforcing a contentious executive order ending birthright citizenship after certifying a lawsuit as a class action, effectively the only way he could impose such a far-reaching limit after a Supreme Court ruling last month.
    • “Ruling from the bench, Judge Joseph N. Laplante of the U.S. District Court for the District of New Hampshire said his decision applied nationwide to babies who would have been subject to the executive order, which included the children of undocumented parents and those born to academics in the United States on student visas, on or after Feb. 20.
    • “The Trump administration has fought to challenge the longstanding law, laid out in the Constitution, that people born in the United States are automatically citizens, regardless of their parents’ immigration status. Judge Laplante’s order reignites a legal standoff that has been underway since the beginning of President Trump’s second term.
    • “The judge, an appointee of President George W. Bush, issued a written order formalizing the ruling on Thursday morning. He also paused his order for seven days, allowing time for an appeal.”

From the Food and Drug Administration front

  • BioPharma Dive lets us know,
    • The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased risk for COVID disease.
    • The shot was previously available for these individuals under emergency use authorization. The company said it expects to have an updated version of its shot available in time for the 2025-2026 respiratory disease season.
    • In May, Health and Human Services Secretary Robert F. Kennedy Jr. announced that COVID vaccines would no longer be recommended for healthy children and pregnant people. The Centers for Disease Control and Prevention currently recommends shared clinical decision-making for healthy children.

From the public health and medical research front,

  • The American Journal of Managed Care tells us,
    • “Ovarian cancer mortality rates have declined, but disparities exist across age, race, and geographic regions, with older women and non-Hispanic White women having the highest rates.
    • “Despite treatment advances, late-stage diagnosis remains a barrier due to the lack of routine screening, resulting in low survival rates for advanced-stage ovarian cancer.
    • “Geographic disparities show the Northeast with the highest mortality rates, while both metropolitan and non-metropolitan areas experienced declines, with metropolitan areas showing a steeper decline.
    • “The study’s limitations include the absence of individual-level data on lifestyle factors, tumor histology, and treatment protocols, hindering causal conclusions.”
  • Radiology Business points out,
    • “Shared decision-making visits significantly boost patients’ adherence to low-dose CT lung cancer screening, according to new research published Wednesday. 
    • “Numerous studies have explored poor uptake of LDCT, with rates as low as 18% among eligible individuals.
    • “Researchers with the American College of Radiology’s Neiman Policy Institute recently explored whether “shared decision-making” visits—required by Medicare as part of CT referrals—can boost screening adherence. They found a clear correlation, with imaging rates nearly 27% higher than those who did not meet with their primary care provider to discuss their risks and benefits of lung cancer screening, according to the study results, published in Chest. 
    • “Shared decision-making is more than just a billing requirement—it’s a valuable opportunity to engage patients in informed, personalized discussions about screening,” study author Farouk Dako, MD, MPH, associate professor of radiology, with the Perelman School of Medicine in Philadelphia, said in a July 9 announcement from the Policy Institute. “There is an opportunity to leverage this new evidence in national campaigns to raise awareness of lung screening and the importance of prioritizing SDM in routine clinical care to improve early detection and outcomes for one of the deadliest forms of cancer.” 
  • Gen Edge relates,
    • Scientists have produced the first detailed characterization of the changes that weight loss (WL) causes in human adipose tissue (AT) by analyzing hundreds of thousands of cells from morbidly obese individuals undergoing weight loss surgery. They found a range of positive effects, including clearing out damaged, aging cells and increased metabolism of harmful fats.
    • The team, headed by William R Scott, PhD, at the MRC Laboratory of Medical Sciences and at Imperial College London, analyzed gene expression in more than 170,000 cells that made up the fat tissue samples from 70 people. They generated a high-resolution single-nucleus and spatial atlas of human AT in people with extreme obesity undergoing therapeutic weight loss and in healthy lean counterparts. The investigators suggest that their findings could help scientists better understand how weight loss leads to health improvements at a molecular level, which in the future could help to inform the development of therapies for diseases such as type 2 diabetes.
    • “We’ve known for a long time that weight loss is one of the best ways to treat the complications of obesity, such as diabetes, but we haven’t fully understood why,” Scott said. “This study provides a detailed map of what may actually be driving some of these health benefits at a tissue and cellular level.”
    • “Scott and colleagues reported on the study in Nature, in a paper titled “Selective remodeling of the adipose niche in obesity and weight loss,” in which they stated, “This rich representation of human AT biology and pathophysiology offers a valuable resource for mechanistic and therapeutic exploration.”
  • The New York Times considers “Just How Harmful Is Vaping? More Evidence Is Emerging. A new study that found high levels of heavy metals in popular nicotine vapes adds to concerns about the products.”
  • Per Fierce Pharma,
    • “Pfizer and Astellas are underlining the benefits of Xtandi as part of a combination therapy for certain patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with an overall survival win.
    • “The new data come from the companies’ phase 3 Embark study, which in 2023 led to the FDA approval of Xtandi in patients with nmHSPC with biochemical recurrence (BCR) at high risk of metastasis.
    • “In the trial, Xtandi was studied as a single agent and in combination with leuprolide against placebo and leuprolide. For the trial’s primary endpoint, the Xtandi combo delivered a statistically significant improvement in metastasis-free survival compared with placebo and leuprolide.
    • “At the time, the trial’s overall survival data were mature.
    • “Now, Xtandi plus leuprolide has proved it can, in fact, extend the lives of these patients, demonstrating a “statistically significant and clinically meaningful improvement” in overall survival, Pfizer announced in a July 10 press release.”

From the U.S. healthcare business front,

  • The WTW consulting firm discusses how to strategically manage health and wellness costs in 2025.
  • Healthcare Dive reports,
    • “UnitedHealth has tapped longtime insurance executive Mike Cotton to lead its Medicaid business, filling a role that has stood empty since the company reshuffled its executive team earlier this year, the company confirmed to Healthcare Dive.
    • “Meanwhile, Bobby Hunter, who leads the healthcare juggernaut’s Medicare division, is stepping up as CEO of government programs, with oversight of both Medicare and Medicaid.”
  • Fierce Healthcare notes,
    • “Health Care Service Corporation is launching the HealthSpring brand for its Medicare products after closing the deal to acquire Cigna’s Medicare plans.
    • “Plans under the HealthSpring label were included in the deal, and HCSC said in an announcement that it refreshed the brand identity for a national rollout. The insurer will offer its first plans under the HealthSpring umbrella later this year, pending needed regulatory approvals.”
  • Fierce Biotech informs us,
    • “AbbVie is paying Ichnos Glenmark Innovation (IGI) $700 million upfront for a next-generation rival to Johnson & Johnson’s Tecvayli, positioning the Big Pharma to advance a new option for multiple myeloma patients.
    • “The deal gives AbbVie rights to ISB 2001, a trispecific antibody that targets CD38, BCMA and CD3. J&J’s Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic hit BCMA and CD3. Adding CD38 to the mix could boost binding to tumor cells with low expression of BCMA and stop cancers from becoming resistant by downregulating the antigens.
    • “AbbVie has placed a high price on that potential, coughing up $700 million for a phase 1 candidate and offering up to $1.225 billion in development regulatory, and commercial milestones. In return, IGI has granted AbbVie rights to the trispecific across North America, Europe, Japan and Greater China.”

Midweek Report

David Ermer–CDC, Congress, FDA, Medical / Rx research, Mental health care, OPM, SDOH, U.S. Healthcare–

From Washington, DC,

  • At 6:45 pm ET, the Senate confirmed by a 49-46 vote the President’s nomination of Scott Kupor to be Office of Personnel Management Director for a four-year term. The confirmation vote followed a 51-46 vote in favor of Mr. Kupor to close debate on his nomination. (Link to Govexec story) Congratulations and best wishes, Mr. Kupor.
  • Govexec tells us,
    • “President Donald Trump’s candidate to lead the Centers for Disease Control and Prevention advanced out of a Senate committee Wednesday following a party-line vote, moving her one step closer to confirmation.
    • “Susan Monarez’s nomination now goes to the floor, where she will likely secure the backing needed to officially take on the role of CDC director after garnering support from Republicans across the political spectrum during the committee’s 12-11 vote.
    • “Senate Majority Leader John Thune, R-S.D., will be in charge of scheduling that vote, though if it isn’t held during the next few weeks, Monarez will have to wait until after the chamber’s August recess.”
  • BioPharma Dive informs us,
    • “President Donald Trump is planning to introduce tariffs of 50% on copper imports and levies “at a very, very high rate, like 200%” on pharmaceutical products, he said at a cabinet meeting Tuesday.
    • “Trump indicated official announcements of the tariffs would come “very soon” but did not elaborate on an exact timeline. He did say, however, that the U.S. would give pharmaceutical importers at least a year to shift their strategies before the implementation of the levies.” * * *
    • “In a note to clients, Leerink Partners David Risinger wrote how the planned grace period is a “positive” for the sector, which has for years built up production capacity in countries like Ireland, Switzerland and the Netherlands. Many generic medicines and drug ingredients, meanwhile, are sourced from India and China.”

From the Food and Drug Administration front,

  • BioPharma Dive relates,
    • “The Food and Drug Administration has approved a modified dosing schedule for Eli Lilly’s Alzheimer’s disease drug Kisunla, permitting a smaller first dose and a more gradual increase that in clinical trials, reduced dangerous episodes of brain swelling, the company said Tuesday.
    • “That side effect, called ARIA, has made physicians reluctant to prescribe the drug and resulted in its use being blocked in some countries. The new dosing protocol will “aid healthcare professionals in evaluating appropriate treatment options for their patients,” said Brandy Matthews, Lilly’s vice president for Alzheimer’s medical affairs, in a statement.
    • “Approved in 2024, Kisunla was the third drug cleared by the FDA to slow Alzheimer’s progression by targeting toxic plaques of a protein called amyloid beta. Despite its potency, sales were only a modest $21 million in the first quarter of 2025.”
  • Mobihealth News points out,
    • “Mendaera, a robotics company, announced it has been granted FDA 510(k) clearance for Focalist, a handheld robotic system, which aims to combine handheld robotics with real-time imaging to enable clinicians to place needles with precision. 
    • “Mendaera said the system integrates robotics, ultrasound imaging and advanced software to make medical procedures more accessible. 
    • “Among Focalist’s features are touchscreen targeting, robotic needle positioning and continuous needle depth tracking, enabling a reproducible procedure experience.
    • “While needle placement is used for a variety of procedures and in a broad range of clinical settings, the initial focus of the system will be in urology. Full commercialization is expected in 2026.”
  • Per Fierce BioTech,
    • “The FDA has cleared its first cuffless blood pressure monitor that will be available over-the-counter, with the Hilo wristband developed by Aktiia. 
    • “According to the Swiss company, the wearable’s optical sensors can capture continuous blood pressure readings similar to the traditional inflated cuff with monthly calibrations, and they have demonstrated accuracy across a variety of skin tones—as well as while the user is sitting, standing or lying down. 
    • “The system previously obtained a CE Mark approval in Europe, and Aktiia said its newly 510(k)-cleared product will reach the U.S. sometime in 2026. The Hilo bracelet has also been given go-aheads in Canada, Australia and Saudi Arabia, and more than 120,000 have already been sold, the company said.
    • “This is not just a regulatory win: it’s the start of a paradigm shift in hypertension management,” Aktiia’s co-founder and chief technology officer, Josep Sola, said in a statement. “With FDA’s OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The US Centers for Disease Control and Prevention (CDC) today reported 21 more measles cases from the past week, pushing the year’s total above a record set in 2019 for the most cases since the disease was eliminated in the United States in 2000.
    • “So far this year, 1,288 cases have been reported from 39 states, and 88% have been part of 27 outbreaks. Among confirmed cases, 92% occurred in people who are unvaccinated or have unknown vaccination status. 
    • “Measles isn’t just striking young children and their school-age peers: about one-third of cases have been reported in those ages 20 and older. The measles surge was initially fueled by a large outbreak in West Texas that began in January, but smaller outbreaks have now been reported from multiple states, along with numerous infections in unvaccinated people who traveled abroad.
    • ‘Measles activity has increased globally, including in North America, where the virus is spreading in communities with large numbers of unvaccinated people—including Mennonite communities linked to large outbreaks in the United States, Canada, and Mexico. Canada has reported 3,703 measles cases this year, the most since it eliminated the disease in 1998.”
  • and
    • “A study of more than 70,000 US pregnancies suggests a commonly used antibiotic for urinary tract infections (UTIs) may be tied to increased risk of congenital malformations when taken during the first trimester of pregnancy.
    • “The study, published today in JAMA Network Open, found that exposure to trimethoprim-sulfamethoxazole (TMP-SMX) during the first trimester was associated with increased risk of any malformation, severe cardiac and other cardiac malformations, and cleft lip and palate compared with beta-lactam antibiotics. No increased risk of congenital malformations was observed with nitrofurantoin, which is also commonly used to treat UTIs.
    • “The study partly substantiates the concerns of the American College of Obstetricians and Gynecologists (ACOG), which has suggested that TMP-SMX and nitrofurantoin be avoided during the first trimester when possible because of uncertainty about the risk of congenital malformations, though studies to date have produced mixed results. Despite the ACOG recommendation, the two antibiotics still account for more than half of first-trimester UTI prescriptions, according to the study authors.” 
  • STAT News adds,
    • “When several countries endorsed the notion of some high-risk people taking the antibiotic doxycycline after unprotected sex to lower their chances of contracting a sexually transmitted disease, as the U.S. did last year, there was a theoretical concern the shift could drive antibiotic resistance in some bacterial infections.
    • “That risk no longer appears to be theoretical.
    • “In a newly published letter in the New England Journal of Medicine, researchers reported a steep rise in resistance to tetracycline — the antibiotic class to which doxycycline belongs — in gonorrhea isolates collected from across the country since results of the studies investigating the use of so-called doxy PEP were made public. PEP is short for post-exposure prophylaxis. 
    • “An earlier report out of the University of Washington showed a similar trend in the Pacific Northwest, as well as a rise in tetracycline resistance in other bacteria carried by people who took doxy PEP, specifically Staphylococcus aureus and group A Streptococcus.”
  • and
    • About 1 in 3 young people who are 12 to 17 years old have prediabetes, new national data show, putting them at risk not just for type 2 diabetes but also for heart disease and stroke. Developing chronic diseases early in life also heightens their chances for worse outcomes from these conditions. 
    • Experts said the data reflect a concerning rise in obesity among teens but also noted that not all teens with prediabetes will progress to diabetes.
    • “The new report from the Centers for Disease Control and Prevention relied on the long-running National Health and Nutrition Examination Survey, which asked adolescents if they’d ever been diagnosed with diabetes and analyzed results of their fasting blood glucose or hemoglobin A1c tests. Its conclusion: In 2023, an estimated 8.4 million adolescents, or 32.7% of 12- to 17-year-olds, had prediabetes.”
  • Health Day lets us know,
    • “Three-quarters of stomach cancer cases could be prevented if doctors eradicate infection by a common type of bacteria, a new study says.
    • “The bacteria, Helicobacter pylori, is linked to 76% of future stomach cancer cases, researchers reported July 7 in the journal Nature Medicine.
    • “Most stomach cancers “are caused by chronic infection with H. pylori and can be prevented by treatment of the infection with a combination of antibiotics and proton pump inhibitors,” wrote the research team led by Jin Young Park, a scientist with the International Agency for Research on Cancer in Lyon, France.” * * *
    • “About 30,300 new cases of stomach cancer will occur in the U.S. this year, and about 10,780 people will die from this type of cancer, according to the American Cancer Society. Most cases occur in seniors.” * * *
    • “In the USA, there are currently no national guidelines or formal recommendations for gastric cancer prevention, although gastric cancer disproportionately affects Asian Americans, Hispanic Americans, African Americans and American Indian-Alaska Native individuals, and an increasing trend in young individuals (age <50 years) has been observed between 2016 and 2022, most notably in women,” researchers wrote.
    • “While H. pylori infections can be easily treated, researchers said it would be best if a vaccine for the bacteria is developed.
    • “Currently, only one H. pylori vaccine has passed phase 3 of a clinical trial,” researchers noted. “More investment in future vaccine trials focusing on pediatric populations should be made, clarifying the mechanisms of vaccine-associated immunoprotection.”
  • and
    • “Uterine cancer incidence and mortality rates are projected to increase significantly through 2050, according to a study published online July 1 in Cancer Epidemiology, Biomarkers & Prevention.
    • “Jason D. Wright, M.D., from the Columbia University College of Physicians and Surgeons in New York City, and colleagues developed a natural history model for uterine cancer to project trends through 2050.
    • “The researchers reported that uterine cancer is projected to increase in incidence and mortality through 2050. Black women will experience a disproportionate rise in incidence compared with White women between 2020 and 2050 (86.9 and 74.2 per 100,000, respectively), as well as a rise in mortality (27.9 and 11.2 per 100,000, respectively). For nonendometrioid tumors, White women will experience only a slight increase, while Black women will experience a substantial increase (10.8 and 36.3 per 100,000, respectively). Hypothetical screening and intervention methods were most effective when introduced at age 55 years with declines in cancer incidence that lasted up to 15 years in White women and up to 16 years in Black women.”
  • and
    • A healthy plant-based diet might protect people from inflammatory bowel diseases, a new study says.
    • People noshing healthy plant-based foods had a 14% lower risk of Crohn’s disease and an 8% lower risk of ulcerative colitis, researchers found.
    • On the other hand, an unhealthy diet containing more animal fats and vegetable oils was associated with a 15% increased risk of Crohn’s disease, results show.
    • “Our research indicates that a healthy plant-based diet may protect against inflammatory bowel disease, with its anti-inflammatory properties playing a key role,” senior researcher Dr. Zhe Shen of the Zhejiang University School of Medicine in China said in a news release.
  • The New York Times reports,
    • “Few practices in mental health are debated more than the long-term use of antidepressant medications, which are prescribed to roughly one in nine adults in the United States, according to data from the Centers for Disease Control and Prevention.
    • “A reassessment began in 2019, when two British researchers published a study that found that 56 percent of patients suffered from withdrawal symptoms when they stopped antidepressant medications and that 46 percent of those described their symptoms as severe.
    • “The findings made headlines in Britain and had a powerful ripple effect, forcing changes to psychiatric training and prescribing guidelines. And they fed a growing grass-roots movement calling to rein in the prescription of psychotropic drugs that has, in recent months, gained new influence in the United States with the rise of Robert F. Kennedy Jr. as health secretary.
    • “A new study, published on Wednesday in the journal JAMA Psychiatry, makes the case that these warnings were overblown. The authors of the new paper found that a week after quitting antidepressants, patients reported symptoms like dizziness, nausea and vertigo, but that they remained, on average, “below the threshold for clinically significant” withdrawal.”
  • Per MedPage Today,
    • “About half of teen vapers said they had tried to quit in the past year, and about a third wanted to try quitting in the next 6 months.
    • “The most common nicotine cessation tools used in these attempts were apps.
    • “No nicotine replacement therapy is approved for youth, but the American Academy of Pediatrics recommends considering off-label use for some adolescents.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck will buy Verona Pharma for roughly $10 billion, adding Ohtuvayre to its cardiopulmonary pipeline and portfolio.
    • “The acquisition helps Merck prepare for the loss of patent exclusivity for Keytruda in 2028.
    • “Verona shareholders will receive $107 per share, a 23% premium to Tuesday’s closing price.”
  • Healthcare Dive notes,
    • “Health insurers are steadily expanding their control over the U.S. primary care market — especially in areas with a lot of seniors eligible for Medicare Advantage plans, according to new research.
    • “In 2023, payer-operated practices accounted for 4.2% of the national Medicare primary care market by service volume, up from 0.8% in 2016, the study published in Health Affairs Scholar found. It’s the first concrete estimate of insurer ownership of physician practices nationwide and suggests that vertical consolidation is being driven by the potential for profits in nudging MA members to owned clinics, researchers said.
    • “The paper could also intensify the microscope on UnitedHealth as lawmakers and regulators scrutinize the healthcare behemoth’s outsized control over the industry. UnitedHealth-owned Optum was the largest operator of primary care clinics of all the insurers included in the analysis, holding more than 2.7% of market share nationally and more than 35% in several large counties.”
  • Per Beckers Health IT,
    • “A recent survey from the American Medical Association found that 66% of medical providers used AI in some capacity in the past year. That represented a dramatic 78% increase from the prior year.  
    • “Usage is only going up, but many providers remain skeptical about AI. Resistance to change is understandable—particularly when AI-focused headlines often seem better described as “clickbait” than substantive. However, practices that dismiss the idea of AI-enabled workflows are missing out on valuable opportunities to measurably boost efficiency, increase patient satisfaction, and reduce costs.  
    • “When applied strategically, AI can make a real impact in day-to-day practice operations and throughout the patient journey. So, how should a practice best determine where to focus efforts when it comes to AI enablement? 
    • “First and foremost, AI adoption should be thoughtful, not frenzied,” says Dr. Sanjeev Kumar, Ph.D., chief data and analytics officer at NextGen Healthcare and a globally recognized AI expert. “An AI-driven tool should always address real need and make life easier for the humans using it.” 
  • Fierce Healthcare adds,
    • “Nabla is integrating its AI medical scribe with Navina’s AI-enabled copilot to provide doctors with an AI layer that supports clinical workflows.
    • “The aim is to deliver real-time support through the full clinical encounter, according to the companies.
    • “The integration combines Navina’s clinician copilot with Nabla’s in-visit ambient documentation, reconciling historical patient records with live patient dialogue to help improve patient outcomes and financial performance.” 
  • Per Beckers Clinical Leadership,
    • “Columbus-based Ohio State University Wexner Medical Center and James Comprehensive Cancer Center researchers found about 1% to 2% of all inpatient hospitalizations resulted in patients discharging against medical advice — and these patients led to more than $800 million in annual associated healthcare costs.
    • “The study, published June 26 in Journal of the American College of Surgeons, used the data from 1,768,752 surgical patients between 2016 and 2020 in the Nationwide Readmissions Database. All patients underwent major surgeries in various medical specialties. Researchers evaluated trends in DAMA incidence, postoperative outcomes, risk factors for DAMA and 30-day healthcare expenditures.”

Tuesday report

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

From Washington, DC,

  • The FEHBlog watched the closing of today’s Senate session. He learned that late tomorrow morning the Senate will vote to invoke cloture on the nomination of Scott Kupor to be OPM Director for a four-year term and if cloture is invoked the Senate will vote to confirm Mr. Kupor’s nomination tomorrow afternoon.
  • Govexec tells us,
    • “President Trump on Monday extended his administration’s hiring freeze of all federal civilian positions for another three months, leaving in place the moratorium into the start of fiscal 2026.
    • “The freeze, which the president initially ordered on Jan. 20, the day he took office, prevents the hiring of civilian employees at federal agencies for either vacancies or new positions. The initial executive order was set to run through April 20 and was subsequently extended until July 15.
    • “As with previous orders, the freeze exempts positions related to immigration enforcement, national security or public safety, as well as the components of the Executive Office of the President. The order also reiterated that roles will be filled to protect the “provision of Social Security, Medicare, or veterans’ benefits.” Despite the carveouts, the Defense Department continues to operate under a partial hiring freeze of its own for civilian personnel.” 
  • Per MedTech Dive,
    • “Boston Scientific said Monday it gained Food and Drug Administration approval for use of its Farapulse pulsed field ablation system in people with persistent atrial fibrillation, broadening the pool of patients eligible for the treatment.
    • “Farapulse has become a significant growth driver for Boston Scientific as physicians embrace the technology for its potential safety benefits over traditional cardiac ablation methods to treat AFib, an irregular heartbeat that increases stroke risk.
    • “The label expansion, for both the Farawave and Farawave Nav PFA catheters, was backed by evidence from the first phase of the Advantage AF clinical trial, which met its primary safety and effectiveness goals.”
  • Cardiovascular Business adds,
    • “Boston Scientific has received an expanded approval from the U.S. Food and Drug Administration (FDA) for its Farapulse Pulsed Field Ablation (PFA) System. More U.S. heart patients are now eligible to be treated with the technology than ever before.
    • “The Farapulse PFA system first gained FDA approval to treat patients with symptomatic, paroxysmal atrial fibrillation (AFib) back in January 2024. This new approval covers patients with symptomatic, persistent AFib that is resistant to drug treatment. 
    • “Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AFib treatment with safe and effective ablation technologies,” Brad Sutton, MD, chief medical officer of AFib solutions for Boston Scientific, said in a statement. “We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.”

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court on Tuesday lifted a halt on President Trump’s plan to shrink the federal workforce, clearing the way for potential mass layoffs. 
    • “In February, Trump issued an executive order aimed at drastically reducing the government’s workforce “by eliminating waste, bloat, and insularity.” The order directed heads of agencies to work with the Department of Government Efficiency on hiring decisions and developing plans for layoffs. In May, a federal judge in San Francisco blocked it from taking effect
    • “The high court, in an unsigned order on Tuesday, said it had based its decision on the legality of Trump’s executive order, and didn’t rule on whether any reorganization plans broke the law.  
    • “The Government is likely to succeed on its argument that the Executive Order and Memorandum are lawful,” the court said. 
    • “Justice Ketanji Brown Jackson dissented, accusing the court of greenlighting legally dubious actions.” * * *
    • “Justice Sonia Sotomayor on Tuesday wrote separately to concur with the court’s decision to lift the halt, noting that the plans themselves weren’t before the high court. She said the district court could still consider the legality of the layoff plans.”
       
  • Fedweek adds,
    • OPM said “hundreds of thousands” of federal employees accepted deferred resignation offers while confirming that “tens of thousands” are facing layoffs in pending RIFs.
    • OPM made that statement in the first—although not exact—accounting of the government-wide impact of those offers, and touted a reduction in the federal employee count on its FedScope site to just under 2.29 million through March, down by some 23,000 from last September.
    • “In addition, hundreds of thousands more workers will drop off the rolls in October 2025, when workers depart the federal government as part of the Deferred Resignation Program; and tens of thousands of employees who have received reduction-in-force or termination notices remain on government payrolls due to court orders that the administration is now challenging,” the OPM said prior to Tuesday’s SCOTUS decision siding with the White House.
  • Per Fierce Healthcare,
    • “Southwest Airlines is buckling up to join in on a long-running legal battle surrounding an alleged price-fixing scheme involving generic medicines in the U.S.
    • “In a 730-page lawsuit filed in federal court in Pennsylvania, the airline targets dozens of drugmakers and argues the companies “deprived the public” of the benefits of cheaper generic drugs by fixing the price of their meds since at least 2009. Among the generic defendants named are Teva Pharmaceutical Industries, Sandoz, Dr. Reddy’s Laboratories, Lupin and Apotex.
    • “The scheme cost Southwest, a large employer that self-funds its employee health plans, “hundreds of millions of dollars” and caused “substantial injury” to its business, the company claims in the recently unsealed lawsuit.” * * *
    • “American Airlines and Target are among other large employers that have sued the group of generic drugmakers. The companies filed a joint lawsuit in the same court back in April 2024, Bloomberg Law reported at the time. 
    • “The issue is also playing out in pending multi-district litigation grouping more than 20 separate lawsuits that date back to 2016. A handful of drugmakers, including Sandoz, Apotex, and Sun Pharma, have so far agreed to multi-million dollar settlements to resolve their end of the claims.” * * *
    • “Southwest, for its part, cited the federal government’s prosecution efforts in its own case. At least seven companies have admitted to criminal wrongdoing, according to the Department of Justice, and have agreed to fork over hundreds of millions of dollars in fines, civil penalties and restitution.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention July 7 announced it is streamlining H5N1 bird flu updates with its routine influenza data given the low public health risk and lack of person-to-person spread. Data on the number of people monitored and tested for bird flu will be reported monthly.
    • “Bird flu detection data in animals will no longer be reported on the CDC website; instead, it will be publicly available on the U.S. Department of Agriculture website.”
  • and
    • “A study published July 7 by JAMA found children’s health has significantly worsened from 2007 to 2023. Researchers studied changes in child mortality; chronic physical, developmental and mental health conditions; obesity; sleep health; early puberty; limitations in activity; and physical and emotional symptoms. Researchers said the findings highlight the need to identify root causes for the decline in health.”
  • Beckers Clinical Leadership lets us know eight things to know about the JAMA report on children’s health.
  • STAT News reports,
    • “Female hearts are different from male hearts, down to their cell populations and up to the thickness of their walls, making cardiovascular care far from one-size-fits-all. There’s a growing appreciation that heart attack symptoms occur on a spectrum. Women may not have the classic crushing chest pain that men do; they may feel a subtler, wider discomfort that can delay care. 
    • “There’s another potentially deadly, dramatic difference. Men are much more likely than women to suffer sudden cardiac arrest, but when female athletes do collapse on the playing field from sudden cardiac arrest, they are less likely than male athletes to be resuscitated right away, despite coaches, trainers, or teammates watching on the sidelines. That’s a disparity women share outside sports events with people of color, whose chances of receiving life-saving help from bystanders are even lower. 
    • “Across disciplines, scientists are arguing for the importance of studying sex differences throughout biomedical research. Sports medicine researchers are also bringing new attention to women, from young competitors in the spotlight to older amateurs trying to stay active.” “
  • Beckers Hospital Review points out,
    • “Mississippi had the highest mortality rate across all cancer types between 2018 and 2022, according to data published by the American Cancer Society. 
    • “The American Cancer Society used data from the North American Association of Central Cancer Registries to calculate mortality rates per 100,000 people for each state and each cancer type.
    • “Read the states with the highest cancer incidence, by type, here.”
  • and
    • “A commonly prescribed medication used to counteract lung cancer therapy side effects could be minimizing a cancer treatment’s efficacy, according to research from Los Angeles-based Keck Medicine of USC. 
    • “To evaluate how baseline steroid use can affect immune checkpoint inhibitor therapy, researchers analyzed clinical outcomes of 277 patients with non-small cell lung cancer. Corticosteroids, a frequently prescribed steroid to treat side effects common to this type of lung cancer, was associated with worse outcomes, the study found. 
    • “Among 88 patients at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., and 189 at the University of Southern California in Los Angeles who received immune checkpoint inhibitor therapy, 21 were taking steroids at the start of ICI therapy. Compared to those not taking corticosteroids, these patients experienced a higher number of negative effects. 
    • “The study, published July 7 in Cancer Research Communications, found a worse overall response rate and shorter overall survival and progression-free survival rates among lung cancer patients taking the steroid concurrent with ICI therapy. 
    • “Additionally, higher doses of corticosteroids severely affected ICI therapy and patient outcomes more than small or medium doses.”
  • Per Health Day,
    • “Some women have expressed concerns about the risk of breast cancer associated with using hormone therapy to treat symptoms of menopause like hot flashes and night sweats, and now, new research suggests that one type of hormone therapy might increase your risk if you’re younger than 55.
    • “Women in this age group who were treated with estrogen plus progestin were more likely to develop breast cancer than those not on hormone therapy, researchers report in The Lancet Oncology.
    • “On the other hand, women younger than 55 given estrogen alone, without progesterone, had a lower risk of breast cancer, results show.
    • “Hormone therapy can greatly improve the quality of life for women experiencing severe menopausal symptoms or those who have had surgeries that affect their hormone levels,” lead author Katie O’Brien, an epidemiologist with the National Institute of Environmental Health Sciences, said in a news release.”
  • Per BioPharma Dive,
    • “Biotech and pharma companies are searching for ways to “hijack” the cell’s waste disposal systems in hopes of making more effective drugs.”
  • and
    • “Glucotrack, which is developing a glucose monitor that is implanted through a minimally invasive surgery, said the small study met safety and performance goals.”

From the U.S. healthcare business front,

  • Risk and Insurance reports,
    • “Medical stop loss claims are undergoing significant shifts as cancer diagnoses remain dominant across all deductible levels while million-dollar claims have doubled in frequency over four years, driven by expensive treatments and rising disease prevalence among younger populations, according to analysis by QBE.” * * *
    • “View the full report here.”
  • Check out Adam J. Fein who writes in Drug Channels,
    • “The 2025 launch of biosimilars to Johnson & Johnson’s Stelara (ustekinumab) marks another turning point in pharmacy benefit dynamics. But unlike the chaotic rollout of Humira biosimilars, pharmacy benefit managers (PBMs) came prepared.
    • “Private label strategies, aggressive pricing, and exclusive formulary deals have transformed what might have been a slow-crawling biosimilar introduction into a full-on pricing war. As with Humira, the reality of biosimilar economics is far messier—and more revealing—than the policy narratives suggest.
    • “In this post, I examine how the major PBMs—and some of the smaller ones—are handling Stelara biosimilars, what’s changed since the Humira experience, and why their strategies reflect the growing dominance of private-label rebating schemes.”
  • Beckers Hospital Review calls attention to “18 health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2025, and considers the state of virtual nursing
    • “Virtual nursing has continued to expand since bursting onto the scene a few years ago. But has the care model lived up to its promise?
    • “Health system leaders told Becker’s that virtual nursing still has room to grow but has had positive benefits for the industry thus far.
    • “While virtual nursing has proven effective at boosting patient outcomes and satisfaction, its broader adoption faces significant barriers: high implementation costs, complex regulatory policies and the challenge of integrating new hospital workflows,” said Zafar Chaudry, MD, senior vice president and chief digital, AI and information officer of Seattle Children’s.”
  • Per Fierce Healthcare,
    • “Nearly all states saw declines in the number of acute care hospitals offering obstetric services between 2010 through 2022, with seven states seeing a quarter or more of their hospitals dropping obstetric care, according to new analysis.
    • “The shutdowns were spread across urban and rural hospitals alike, but more pronounced in the latter. Twelve states lost obstetric services among a quarter or more of their hospitals, and by 2022, there were eight states in which more than two-thirds of all rural hospitals did not offer obstetric care, researchers found.” * * *
    • “Rural hospital obstetrics closures exceeded more than 40% in Pennsylvania (46.2%), South Carolina (46.2%), West Virginia (42.9%) and Florida (40%) between 2010 and 2022. Urban hospital closure percentages were less pronounced among individual states, with Rhode Island (28.6%), Oklahoma (27.6%) and Hawaii (25%) leading the way.
    • “Three states—Delaware, Utah and Vermont—had no hospital obstetric service losses during the study window, as opposed to the seven (Iowa; Oklahoma; Pennsylvania; Rhode Island; South Carolina; Washington, D.C.; and West Virginia) that saw cuts among a quarter or more of their hospitals. Rural-urban divides were also spotted within individual states, such as New Hampshire, where 36.4% of rural hospitals lost obstetrics as opposed to zero urban hospitals.
    • “Access to obstetric care is a key determinant of health outcomes among mothers and infants, the researchers wrote. The study’s findings could be a resource for policymakers and others to craft targeted, state-level interventions addressing access disparity.”
  • and
    • “Humana’s senior-focused primary care unit is set to acquire The Villages Health, which provides care to the large Florida-based retirement community.
    • “The Villages Health filed for bankruptcy last week as it seeks to undergo a strategic restructuring designed to “preserve the business’s day-to-day operations and further enhance patient care.” Humana’s CenterWell has entered a “stalking horse” agreement to buy TVH’s assets, according to an announcement.
    • “Finalizing the sale will require a court order after an auction process that accepts additional bids. As it navigates the sale and bankruptcy proceedings, The Villages Health said it will continue to operate as normal, with the goal of averting disruptions to patient care.
    • “As CenterWell is payer-agnostic, current TVH patients are “expected” to be able to maintain the relationship with their existing providers, according to the release.”

Monday update

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog noticed today that the Speaker of the House of Representatives has declared this week to be a District work week for members of the House. As a result, the previously scheduled House Committee meetings have been cancelled or postponed.
  • Fierce Healthcare reports,
    • “Congress has made permanent a pandemic-era telehealth provision for millions of Americans with high-deductible health plans.
    • “In its massive tax package signed into law on July 4, Congress included a last-minute provision to allow employer-sponsored health plans to offer covered telehealth services before employees meet their deductibles.
    • “Under high deductible health plans, patients typically have to pay out of pocket for healthcare services until they meet their deductible, with an exception for preventive care services. 
    • “Now, employers will be able to offer digital healthcare services to their employees for little to no out-of-pocket cost. The telehealth safe harbor policy also allows employers to waive copays for digital health. 
    • “Congress extended the tax provision multiple times throughout the COVID-19 pandemic to allow commercially insured patients the option to receive care from anywhere. The policy was allowed to lapse at the end of 2024 when it did not make it into the end-of-year healthcare package. 
    • “The telehealth safe harbor policy in reconciliation applies to all plan years beginning after December 31, 2024.”
  • MedPage Today tells us,
    • With the CDC director’s chair still empty, HHS Secretary Robert F. Kennedy Jr. endorsed recommendations made months ago by former members of the Advisory Committee on Immunization Practices (ACIP) to expand access to respiratory syncytial virus (RSV) vaccination, as well as to add a new option for meningococcal vaccination. * * *
    • “A notice this [past] week appeared on the CDC’s website, which details the recommendations from the April ACIP meeting: “With no current CDC Director and pending confirmation of a new CDC Director this recommendation was adopted by the HHS Secretary on June 25, 2025, and is now an official recommendation of the CDC.”
    • The new RSV recommendation calls for a single dose of vaccine for adults age 50 to 59 years who are at increased risk of severe RSV disease. 
    • “The CDC also endorsed the previous ACIP members’ recommendation that GSK’s pentavalent Neisseria meningitidis (groups A, B, C, W, and Y) vaccine (Penmenvy) may be used when both the MenACWY and MenB vaccine are indicated at the same visit. That recommendation applies to healthy people ages 16 to 23 years “when shared clinical decision-making favors administration of MenB vaccine.” The recommendation also covers people age 10 years or older “who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia).” Committee members also voted to include the shot in the Vaccines for Children program.”
  • The Washington Post informs us,
    • “The Department of Veterans Affairs said Monday [July 7] that it will no longer be forced to conduct a large reduction in workforce, unlike several other federal agencies that were forced to make mass layoffs because of the Trump administration’s U.S. DOGE Service.
    • “In a news release, VA said that it was on pace to reduce its total staff by nearly 30,000 employees by the end of this fiscal year, a push that the department said eliminates the need for a “large-scale reduction-in-force.” The announcement marks a significant reversal for the Trump administration, which had planned for months to cut VA by roughly 83,000 employees, according to plans revealed in an internal memo circulated to agency staffers in March.” 
  • MedTech Dive lets us know,
    • “The U.S. plans to charge up to 70% tariffs on imports from some countries starting Aug. 1 as President Donald Trump’s 90-day pause on his country-specific reciprocal duties nears its expiration date.
    • “Starting Monday at noon EST, the U.S. will send letters detailing tariff rates for specific trading partners that have yet to reach a tariff deal with the Trump administration before the pause ends July 9, the president said Sunday. Trump told reporters Friday that the rates would range between 10% and 70%.
    • “The U.S. is specifically focused on “18 important trading relationships,” Treasury Secretary Scott Bessent said on CNN’s “State of the Union” Sunday. He also indicated that countries that do not reach deals in the next few days will return to the tariff rate Trump first outlined as part of the president’s global reciprocal tariff announcement April 2.
    • “President Trump’s going to be sending letters to some of our trading partners, saying that, if you don’t move things along, then, on August 1, you will boomerang back to your April 2 tariff level,” Bessent said.”
  • The American Hospital Association (AHA) News relates,
    • The National Institutes of Health July 3 announced that all NIH-funded research published in scientific journals must be made publicly accessible immediately upon release, accelerating a policy originally set to begin in December. Previously, many NIH-funded studies in journals were password-protected and not widely available to nonsubscribers.

From the judicial front,

  • Healthcare Dive reports,
    • “Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations.
    • Filed Monday, the lawsuit argues that Kennedy’s directive, which removed guidelines recommending COVID vaccination for pregnant people and healthy children, is unlawful and “a pressing public health emergency that demands immediate legal action and correction.”
    • “The Directive is but one example of the Secretary’s agenda to dismantle the longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans,” the suit states.
    • “Plaintiffs include the American Academy of Pediatrics, the American Public Health Association, the Infectious Diseases Society of America and several other groups.”
    • The case is captioned American Academy of Pediatrics v. Kennedy, Case No. 1:25-cv-11916 (D. Mass.).

From the public health and medical research front,

  • Last Wednesday, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced, 
    • “Kraft Heinz Foods Company, a Newberry, S.C., establishment, is recalling approximately 367,812 pounds of fully cooked turkey bacon products that may be adulterated with Listeria monocytogenes (Lm). The turkey bacon was produced from April 24, 2025, through June 11, 2025. The following products are subject to recall [view labels]:
      • “12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548601” printed on the packaging under the barcode,”use by” dates ranging “18 JUL 2025” to “02 AUG 2025,” and lot code “RS40.”
      • “36-oz. packages containing three 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548748” printed on the packaging under the barcode, “use by” dates ranging “23 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
      • “48-oz. packages containing four 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and UPC “071871548793” printed on the packaging under the barcode and “use by” dates ranging “18 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
    • “The products subject to recall bear the USDA mark of inspection on the front of the label. These items were shipped to retail locations nationwide and some were exported to the British Virgin Islands and Hong Kong.” * * *
    • “FSIS is concerned that some products may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.”
  • Per Axios.
    • “It’s not food, it’s not chewing tobacco and it’s not gum — though it might look like it when you see it — but it is becoming America’s new addictive obsession.
    • “Sales of Zyn nicotine pouches are soaring, prompting the tobacco company that makes them to scramble to boost U.S. production to meet demand.” * * *
    • “Threat level: The product is addictive because nicotine is addictive.
      • “But it does not cause cancer since it doesn’t contain tobacco, whose harmful chemicals are carcinogenic. As a result, advocates say nicotine pouches can serve as a safer alternative to smoking.
      • “Philip Morris International U.S. CEO Stacey Kennedy argued that nicotine is “misunderstood” and contains “cognitive benefits.”
      • “You have to be able to separate out the misconceptions of what causes harm — and nicotine is probably one of the most misunderstood compounds, because many people believe that nicotine is responsible for smoking-related disease, and it’s not,” Kennedy said in an interview.
    • Yes, but: Tobacco industry watchdogs say products that contain nicotine, such as pouches and e-cigarettes, can serve as a gateway to smoking, especially for teens.
  • Per MedPage Today,
    • “Parent nudges and clinician feedback/audits boosted HPV vaccination uptake and completion.
    • “Adolescents with the most economic disadvantage, rural kids, and Black children saw the least benefit.
    • “More research is needed to tailor interventions to improve HPV vaccine uptake and completion for these groups.”
  • The American Medical Association lets us know what doctors wish their patients knew about hyperthyroidism.
  • Consumer Reports, writing in the Washington Post, points out “What to eat to protect your aging muscles. The foods you choose are as important as exercise for getting and staying strong.”
  • BioPharma Dive informs us,
    • After a delay due to “resource constraints,” the Food and Drug Administration on Monday [July 7] approved Kalvista Pharmaceuticals’ pill Ekterly to treat swelling attacks in people with the rare disorder hereditary angioedema.
    • Ekterly is the first oral drug to treat hereditary angioedema, or HAE, attacks, competing with shots like Firazyr from Takeda and Ruconest from Pharming. Analysts have estimated Ekterly, Kalvista’s first marketed drug, could bring in $600 million a year in U.S. sales at its peak.
    • The FDA delayed the decision beyond its June 17 deadline, Kalvista said, because of a “heavy workload and limited resources.” While Kalvista awaited its decision, the FDA granted approval to another HAE drug, CSL’s Andembry, a preventive shot that won’t compete directly with Ekterly.
  • STAT News reports,
    • “Apogee Therapeutics said Monday [July 7] that its experimental antibody treatment alleviated the signs and symptoms of atopic dermatitis, a common inflammatory skin condition, far more than a placebo — achieving the efficacy goals of a mid-stage clinical trial.
    • “In a side-by-side comparison, the Apogee drug, called APG777, showed similar skin-clearance rates compared to two antibody treatments already on the market: Sanofi and Regeneron’s Dupixent and Ebglyss from Eli Lilly. 
    • “APG777 was designed to be injected quarterly or twice-yearly, which, if proven in later clinical trials, would make it more convenient than the twice-monthly and monthly injections required for its competitors.” 
  • and
    • “Cogent Biosciences said Monday that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis. The results mean the drug achieved the goals of a Phase 3 study, but a comparison to a rival treatment from Blueprint Medicines remains muddled. 
    • “In its study, Cogent’s drug, called bezuclastinib, showed a 24-point improvement in a patient-reported symptoms score, compared to a 15-point improvement for participants given a placebo. The nine-point difference was statistically significant. 
    • “Indolent systemic mastocytosis is the most common form of an immune system disorder that causes allergic-like skin reactions, gastrointestinal and neurological symptoms, fatigue, and generalized pain.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Molina Healthcare warned higher medical costs will hit earnings this year, adding to Wall Street worries.
    • “New legislation will shrink the number of insured, especially Medicaid, creating uncertainty for insurers.
    • “Insurers are seeing that rising mental-healthcare use and costly drugs, like weight-loss medications, increase spending.”
  • Per MedPage Today, “Obesity Drug Prices Are Dropping, but Getting a Steady Supply Remains a Challenge — Insurance coverage remains inconsistent.”
  • Beckers Hospital Review lets us know,
    • “A new study suggests that the introduction of a real-time prescription benefit tool did not lead to meaningful changes in prescription spending or medication use among Medicare Advantage beneficiaries during its first year of implementation. 
    • “The analysis, published in JAMA Network Open, examined more than 2.8 million beneficiaries and compared patients treated with access to the tool to those without it. The tool, integrated into EHRs in 2019, helps provide clinicians with real-time cost and coverage information at the point of prescribing. 
    • “Despite hopes that the tool would lower out-of-pocket costs and increase prescription adherence by guiding prescribers toward lower cost alternatives, the study found no significant difference in total prescription spending, out-of-pocket costs or number of prescription fills between the two groups.” 

Weekend update

David Ermer–Congress, FDA, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • On July 4, the President signed into law H.R. 1, the budget reconciliation act. The law’s one FEHB provision creating the FEHB Protection Act of 2025 begins on page 766 of the new law.
  • The Senate Executive Calendar for July 7, 2025, includes a Unanimous Consent Agreement that reads as follows:
    • Ordered, That at 5:30 p.m. on Tuesday, July 8, 2025, notwithstanding Rule XXII, the cloture motions filed on the following nominations ripen:
    • Preston Griffith, of Virginia, to be Under Secretary of Energy;
    • Bryan Bedford, of Indiana, to be Administrator of the Federal Aviation Administration for the term of five years;
    • Scott Kupor, of California, to be Director of the Office of Personnel Management for a term of four years; and
    • William Briggs, of Texas, to be Deputy Administrator of the Small Business Administration. (July 1, 3, 2025.).
  • Odds are that Mr. Kupor will be sworn in as OPM Director later this week.

From the judicial front,

  • Bloomberg Law reports,
    • “Among the federal appeals courts, the Fourth Circuit was the biggest loser at the US Supreme Court this term.
    • “The Richmond, Virginia-based court had the second-highest number of its rulings reviewed by the justices and they reversed everyone.
    • “The data suggests attorneys have been testing the waters to see if the liberal-leaning court could counterbalance the conservative Fifth Circuit on the right as a preferred venue for progressive causes. A 100% reversal rate at the Supreme Court, however, may make litigants rethink that strategy in certain cases.”

From the public health and medical research front,

  • The Hill reported on July 3,
    • “The Food and Drug Administration (FDA) upgraded a blueberry recall this week to the highest risk level amid concerns of contamination. 
    • “The FDA raised the recall of 400 boxes that weigh 30 pounds to Class I.
    • “The blueberry recall, which took place June 9, was initiated after Alma Pak International LLC of Alma, Ga. received a positive result of listeria monocytogenes during routine testing, according to the FDA. 
    • “FDA’s Class I classification is a “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” 
    • “The firm shipped the blueberries to one customer in North Carolina. The number of the recall is H-0204-2025.” 
  • The Wall Street Journal informs us,
    • “Ticks! They’re summer’s most unwelcome guests and are lurking everywhere: on golf courses and hiking trails, in backyard gardens and even in city parks. 
    • “And this year appears to be especially bad: Emergency-department visits for tick bites are the highest since 2019, according to the Centers for Disease Control and Prevention tick-bite data tracker.
    • “The tick index run by Fordham University’s Louis Calder Center is currently at nine out of 10. “If you’re thinking of taking a hike, consider going to a movie instead,” the website says.” * * *
    • Use a tick key—it’s a small, cheap tool you can buy in lots of places—or fine-tipped tweezers and grasp the tick as close to the skin’s surface as possible. (In a pinch you could use a credit card.) Pull with a steady, even pressure and try not to twist or jerk the tick. You need to remove the whole tick, not just break off part of it. Also, don’t try to use a match or solvent.
    • If you find one tick, make sure to do a thorough tick check on the rest of your body. Look behind your knees, under your arms, behind your ears and around your crotch.
  • Medscape discusses “Intermittent Fasting and Type 2 Diabetes: When to Recommend and When to Avoid This Eating Plan.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive reports,
    • “U.S. government officials said critical infrastructure operators should be on alert for Iranian cyberattacks.
    • “In a threat advisory published Monday [June 30], multiple agencies said Iran might target U.S. firms “for near-term cyber operations” due to “the current geopolitical environment” — a reference to the Trump administration joining Israel’s aerial campaign against Iran’s nuclear program and related assets.
    • “Defense contractors, especially firms that have relationships with Israeli companies, are likely at heightened risk of targeting, according to the advisory.”
  • and
    • “The Department of Justice on Monday [June 30] announced a series of actions as part of an investigation into the North Korean government’s deployment of its citizens abroad to pose as IT workers and illicitly earn money for the regime.
    • “Newly unsealed charging documents describe two separate schemes to trick U.S. companies into hiring people who funneled their paychecks to the North Korean government and exploited their access to the companies’ networks to steal sensitive information and cryptocurrency.
    • “Law enforcement officials, who have repeatedly issued alerts about Pyongyang’s IT worker schemes, warned U.S. businesses on Monday to carefully screen their remote employees to avoid falling victim to similar ruses.
  • Cyberscoop tells us,
    • “The Chinese hackers behind the massive telecommunications sector breach are “largely contained” and “dormant” in the networks, “locked into the location they’re in” and “not actively infiltrating information,” the top FBI cyber official told CyberScoop.
    • “But Brett Leatherman, new leader of the FBI Cyber division, said in a recent interview that doesn’t mean the hackers, known as Salt Typhoon, no longer pose a threat.
    • “While there’s been some debate about whether Salt Typhoon should be getting more attention than fellow Chinese hackers Volt Typhoon — whom federal officials have said are prepositioned in U.S. critical infrastructure, poised for destructive action in the event of a conflict with the United States — Leatherman said the groups aren’t as different as some think.
    • “Salt Typhoon, even though it was [an] espionage campaign, had access to telecommunications infrastructure,” he said. “You can pivot from access in support of espionage to access in support of destructive action.”
  • and
    • “Federal authorities levied sanctions Tuesday on Aeza Group, a bulletproof hosting service provider based in Russia, for allegedly supporting a broad swath of ransomware, malware and infostealer operators.
    • “Aeza Group has provided servers and specialized infrastructure to the Meduza, RedLine and Lumma infostealer operators, BianLian ransomware and BlackSprut, a Russian marketplace for illicit drugs, according to the Treasury Department’s Office of Foreign Assets Control. Lumma infected about 10 million systems before it was dismantled through a coordinated global takedown in May.
    • “The Treasury Department’s action against Aeza Group follows a wave of cybercrime crackdowns across the globe. Prolific cybercriminals have been arrested, and infostealers, malware loaders, counter antivirus and crypting services, cybercrime marketplaces, ransomware infrastructure and DDoS-for-hire operations have all been seized, taken offline or severely disrupted by global coordinated campaigns since May.
    • “Officials accused Aeza Group of helping cybercriminals target U.S. defense companies and technology vendors.”

From the cybersecurity breaches and vulnerabilities front,

  • Cybersecurity Dive informs us,
    • “Australian carrier Qantas said hackers who breached one of its call centers stole a significant quantity of customer data.
    • “The airline said on its website that it detected unusual activity on Monday [June 30] on a third-party platform that one of its call centers used. The airline took immediate action and was able to contain the attack, which it blamed on a criminal hacker.
    • “Qantas said it is investigating the extent of the intrusion but warned that the hackers accessed a “significant” amount of customer data, including names, addresses, phone numbers, dates of birth and frequent-flyer numbers. 
    • “The breach did not compromise any credit card details, personal financial information or passport information, Qantas said, because those are stored in a separate system. The intrusion also did not expect login information for customers’ frequent-flyer accounts.
    • “Qantas said it was working with government authorities, including the Australian Cyber Security Centre and the National Cyber Security Coordinator, as well as independent forensic experts to investigate the breach.
    • “All of Qantas’ systems are now secure and the airline is operating normally, according to the company. It said it was in the process of contacting customers to alert them to the incident.” 
  • Per Security Week,
    • “Missouri healthcare provider Esse Health is notifying over 263,000 people that their personal information was stolen in a disruptive April 2025 cyberattack.
    • “The incident was discovered on April 21 and impacted the organization’s access to the electronic medical record system, while also taking down its phone system.
    • “By May 13, the healthcare provider had restored certain systems and was able to fulfill scheduled appointments or procedures. The phone systems were restored in early June, along with other primary patient-facing network systems, the organization said in an incident notice.
    • “On June 20, Esse Health said its investigation into the attack determined that a threat actor breached its network on April 21 and stole files containing personal information.
    • “The exfiltrated data included names, addresses, dates of birth, Social Security numbers, medical record numbers, patient account numbers, health information, and health insurance details.”
  • and
    • “Benefits and payroll solutions firm Kelly & Associates Insurance Group (dba Kelly Benefits) has informed authorities that a recent data breach impacts more than 550,000 people.
    • “The company revealed in April that hackers had gained access to its systems in December 2024, and an investigation had shown that the threat actor managed to steal files storing personal information.
    • “The incident resulted in the theft of information such as name, date of birth, Social Security number, tax ID number, medical information, health insurance information, and financial account information. 
    • “Kelly Benefits is notifying impacted individuals on behalf of more than 40 affected customers, including Aetna Life Insurance Company, Amergis, Beam Benefits, Beltway Companies, CareFirst, The Guardian Life Insurance Company of America, Fidelity Building Services Group, Intercon Truck of Baltimore, Humana Insurance ACE, Merritt Group, Publishers Circulation Fulfilment, Quantum Real Estate Management, United Healthcare, and Transforming Lives.
    • “Data breach reports submitted by Kelly Benefits to the Maine Attorney General’s Office since early April show that the number of impacted individuals has steadily increased as the company’s investigation progressed.” 
  • The Center for Medicare and Medicaid Services announced on June 30,
    • The Centers for Medicare & Medicaid Services (CMS) is notifying Medicare beneficiaries whose personal information may have been involved in a data incident affecting Medicare.gov accounts. CMS identified suspicious activity related to unauthorized creation of certain beneficiary online accounts using personal information obtained from unknown external sources. CMS takes this situation very seriously. The safeguarding and security of personally identifiable information is of the utmost importance to CMS. 
    • Following detection of the incident, CMS worked quickly to deactivate affected accounts, assess the scope and impact of the compromise, and mitigate the effects on impacted individuals. CMS is working closely with appropriate parties to investigate this situation.
    • Approximately 103,000 beneficiaries may have been impacted. Notifications to affected individuals are being mailed, informing them of the incident, outlining steps being taken to protect their information, and providing guidance on actions they may wish to take. 
  • The Cybersecurity and Infrastructure Security Agency added five known exploited vulnerabilities to its catalog this week.
  • Dark Reading warns
    • “While browser extensions add useful functionality to Web browsers, such as blocking ads, managing passwords, and taking notes, they also increase the organization’s security and privacy risks.
    • “Browser extensions require certain levels of permissions that are attractive to attackers. Some extensions need access to the user’s location, browsing history, or the user’s clipboard to see what data the user has copied. Some extensions go further, requesting access to nearly all of the data stored on the user’s computer as well as the data accessed while visiting different websites. Attackers can exploit extensions with these heightened permissions to access potentially sensitive information, such as Web traffic, saved credentials, and session cookies.
    • “Even extensions with relatively modest permissions can manipulate those permissions to obtain access to the inner workings of every Web page displayed on a user’s screen, warns LayerX CEO and co-founder Or Eshed. LayerX research shows that 53% of enterprise users have installed extensions labeled with “high” or “critical” permissions scope. This is why browser extensions are a prime avenue for exploitation by threat actors, he adds.  
    • “[Attackers] can use it to copy or rewrite data or exploit Web page permissions for even more access,” Eshed says.”
  • Security Week adds,
    • A vulnerability in the Forminator WordPress plugin could allow attackers to take over more than 400,000 impacted websites.
    • A popular form builder plugin with more than 600,000 active installations, Forminator supports the creation of various types of forms, including contact and payment forms, polls, and more.
    • The WordPress plugin was found vulnerable to CVE-2025-6463 (CVSS score of 8.8), an arbitrary file deletion flaw that exists because file paths are not sufficiently validated in a function used to delete a form submission’s uploaded files.

From the ransomware front,

  • Bleeping Computer reports,
    • “The Hunters International Ransomware-as-a-Service (RaaS) operation announced today that it has officially closed down its operations and will offer free decryptors to help victims recover their data without paying a ransom.
    • “After careful consideration and in light of recent developments, we have decided to close the Hunters International project. This decision was not made lightly, and we recognize the impact it has on the organizations we have interacted with,” the cybercrime gang says in a statement published on its dark web leak earlier today.
    • “As a gesture of goodwill and to assist those affected by our previous activities, we are offering free decryption software to all companies that have been impacted by our ransomware. Our goal is to ensure that you can recover your encrypted data without the burden of paying ransoms.” * * *
    • “Threat intelligence firm Group-IB also revealed in April that Hunters International was rebranding with plans to focus on data theft and extortion-only attacks and had launched a new extortion-only operation known as “World Leaks.”
  • Security Week advises,
    • The key tool for surviving ransomware, or any attack scenario, is an IR plan. But an IR plan is only worthwhile if it’s comprehensive, current, and tested. IR plans are not “best practices”, nor singular documents stored in a safe place. They are living resources that require attention and maintenance. In this way, the proof of an IR plan’s efficacy is in that organizational muscle memory – most effectively trained through Tabletop exercises.  So, what are the primary “muscles,” and the repetitive “exercises” in which you can train an organization to respond decisively, immediately, confidently, and automatically.”
      • Plan your workout
      • Warm up
      • Train, recover, repeat
      • Measure your gains 

From the cybersecurity defenses and business front,

  • Withum offers guidance on how to align your firm’s cybersecurity practices with Labor Department best practices for ERISA plan fiduciaries.
  • Per Security Week,
    • Cloudflare has reversed its block on AI-crawling from optional to default, allowing finer grained crawling but only with agreement from all parties concerned.
    • LLMs are what they learn. From their inception the biggest source of learning has been the internet, so there has been a natural tendency for AI developers to scrape the internet as widely as possible.
    • Cloudflare has now introduced an option for their customers to accept or reject website scraping by AI vendors. Hitherto, internet scraping has been a major part of gathering training data for large LLM (gen-AI) developers; but the process has raised questions and objections over legality, copyright infringement, and accuracy.
  • Dark Reading lets us know,
    • “How businesses can align cyber defenses with real threats. Companies that understand the motivations of their attackers and position themselves ahead of the competition will be in the best place to protect their business operations, brand reputation, and their bottom line.”
  • and
    • “One year after a buggy CrowdStrike update knocked IT systems offline, organizations seeking to strike the right balance between security and productivity have viewed the incident as a learning opportunity.
    • “The cost of the CrowdStrike outage was estimated at $5.4 billion, affecting payment systems, airline reservations, and a variety of other industries. The impact of the outage highlights why many operational technology (OT) teams are as sensitive to patches and other updates in their critical infrastructure, as they are highly averse to outages that can happen if such updates are defective.
    • “But when balancing security and productivity, it is imperative not to view the CrowdStrike outage as a reason to forgo patching completely. The ever-growing volume of vulnerabilities and threats requires organizations to remain resilient and anti-fragile — that is, to have the ability to proactively respond to issues and continuously improve.”
  • Per Security Week,
    • “LevelBlue announced on Tuesday [July 1] that it’s acquiring managed detection and response (MDR) services company Trustwave from The Chertoff Group’s MC² Security Fund.
    • “LevelBlue, formerly known as AT&T Cybersecurity, was launched in May 2024 as a joint venture between WillJam Ventures and AT&T. 
    • “The company’s acquisition of Trustwave comes shortly after it announced plans to buy Aon’s cybersecurity consulting business. The deals are part of a plan to become the largest pure-play managed security services provider (MSSP). 
    • “Once the acquisition has been completed, LevelBlue’s expertise in strategic risk management and cybersecurity infrastructure will be integrated with Trustwave’s platform and MDR service.”
  • Here’s a link to Dark Reading’s CISO Corner.

Thursday report

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

Note to readers: There will be no Friday report this week due to the Fourth of July holiday. Happy Independence Day!

From Washington, DC

  • The Wall Street Journal reports,
    • “The House narrowly passed Republicans’ sprawling tax-and-spending bill, delivering a major second-term victory for President Trump and again demonstrating his power to keep GOP lawmakers in line. 
    • “The 218-214 vote Thursday sends the measure to Trump’s desk, ahead of the July 4 target he set for Congress to finish the legislation that cuts taxes, boosts border security and lowers social safety-net spending. Trump and GOP leaders muscled the bill through the House after an all-night session, despite many lawmakers’ misgivings about the version the Senate passed 51-50 earlier this week.
    • “Two Republicans—Thomas Massie of Kentucky and Brian Fitzpatrick of Pennsylvania—voted with all Democrats against the “one big, beautiful bill.” The vote followed a long day of negotiations with conservative and moderate holdouts, as Trump and Speaker Mike Johnson (R., La.) eventually swayed enough members to prevail.
    • “We’ve had spirited debates, we’ve had months of deliberations, and now we are finally ready to fulfill our promise to the American people,” Johnson said.”
  • The Akin Gump law firm offers a summary of the key tax and healthcare provisions of the One Big Beautiful bill.
  • Govexec tells us,
    • “A postal advocacy group is asking the U.S. Postal Service to pause a planned July 13 increase in the price of stamps until after the new postmaster general begins his tenure. 
    • “Keep US Posted, a nonprofit advocacy group that represents consumers, nonprofits and newspapers, among other entities, in a July 3 letter backed a freeze on mailing rates until Waste Management CEO and FedEx board member David Steiner takes the helm of USPS, which is slated for the day after stamps increase to 78 cents. 
    • “We believe it is counterproductive for another postage surge to take place immediately before you undertake leadership of the Postal Service, as it will deprive you of the ability to thoroughly assess, and potentially rectify, one of the most destructive policies in [former Postmaster General Louis] DeJoy’s Delivering for America plan,” wrote former Rep. Kevin Yoder, R-Kan., the executive director of Keep US Posted.” 
  • Bloomberg Law informs us,
    • “The Department of Labor’s federal contractor watchdog will resume action on complaints under regulations prohibiting bias against veterans and disabled workers. 
    • ‘Labor Secretary Lori Chavez-DeRemer lifted a hold on the Office of Federal Contract Compliance Programs’ enforcement work that had been in place since January, the agency said Wednesday. 
    • “The agency’s enforcement of Section 503 of the Rehabilitation Act and the Vietnam Veterans Readjustment Act were paused after President Donald Trump rescinded the decades-old executive order that gave the agency authority to police and audit race and sex bias at companies that do business with the government. 
    • “Enforcement of Section 503 and VEVRAA regulations was not upended by the Trump order since those OFCCP duties were statutorily established.
    • “Chavez-DeRemer said Section 503 and VEVRAA complaints that were held up during the period of abeyance will resume processing immediately and complaints filed during the pause will move forward normally.”
  • Per MedPage Today,
    • The FDA cleared an artificial intelligence (AI)-powered wristband (Felix NeuroAI) to treat upper-limb functional limitations in adults with essential tremor, device maker Fasikl announcedopens in a new tab or window.
    • The noninvasive, wearable peripheral nerve stimulator connects to a cloud-based AI platform and incorporates patient recordings to continuously adjust settings, allowing therapy to be personalized.
    • Essential tremor is one of the most common types of movement disorders, affecting approximately 7 million people in the U.S.

From the public health and medical research front,

  • Health Day warns,
    • “Tens of thousands of people suffer needless heart attacks and strokes every year because they aren’t taking cholesterol-lowering drugs, a new study says.
    • “More than 39,000 deaths, nearly 100,000 non-fatal heart attacks and up to 65,000 strokes in the U.S. could be prevented if people eligible for statins and other cholesterol-lowering drugs were taking them, researchers reported June 30 in the Journal of General Internal Medicine.
    • “Nearly half of Americans (47%) who’ve never had a heart attack or stroke are eligible to take statins under U.S. guidelines, researchers found.
    • But fewer than a quarter (23%) of them have been prescribed the life-saving drugs, results show.
    • “A substantial number of heart attack or stroke survivors also aren’t taking the drugs, even though all are eligible for them under U.S. guidelines, researchers said.
    • “These results add to a growing body of evidence that there are important shortcomings in the quality of care for common and costly chronic diseases such as high cholesterol, and that addressing those shortcomings would yield major public health benefits,” lead researcher Dr. Caleb Alexander, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, said in a news release.”
  • The New York Times reports,
    • “Screening can be a powerful weapon against cancer, helping catch some tumors months, or even years, before a person would feel sick enough to see a doctor.
    • “There are many different types of cancer, but the U.S. Preventive Services Task Force, a group of independent medical experts, only recommends regular screening for four types: lung, breast, colorectal and cervical. For this quartet, the task force has found that regular screening can save lives without exposing too many people to false alarms, additional testing or unnecessary treatments.
    • “Screening is on the front lines of reducing deaths from cancer,” said Robert Smith, an epidemiologist at the American Cancer Society.” * * *
    • “For some cancer types like skin, oral and bladder, there’s not enough evidence to recommend one way or another. In other cases — like ovarian, pancreatic, testicular, and thyroid cancers — the task force has found that screening people without symptoms can lead to too many false positives and complications without reducing people’s risk of death.
    • “For that reason, the task force recommends against screening older men for prostate cancer but says that men ages 55 to 69 should talk with their doctor to discuss the harms and benefits. Most prostate cancers grow so slowly that they would never be an issue, Dr. Reid said. While screening can find these tumors, it risks a cascade of unnecessary treatments and complications, such as rectal bleeding and impotence.
    • “Sometimes, the treatment is worse than having the cancer,” Dr. Reid said.”
  • and
    • “Drinking is harmful to your health at any age. But as you get older, the risks become greater — even with the same amount of drinks.
    • “Alcohol affects “virtually every organ system in the body,” including the muscles and blood vessels, digestive system, heart and brain, said Sara Jo Nixon, the director of the Center for Addiction Research & Education at the University of Florida. “It particularly impacts older adults, because there’s already some decline or impact in those areas.”
    • “There’s a whole different set” of health risk factors for older drinkers, said Paul Sacco, a professor of social work at the University of Maryland, Baltimore who studies substance use and aging. People might not realize that the drinks they used to tolerate well are now affecting their brains and bodies differently, he said.” * * *
    • “Drinking alcohol can increase the risk of developing chronic conditions like dementia, diabetes, cancer, hypertension and heart disease. But it can also worsen outcomes for the majority of older adults already living with chronic disease, said Aryn Phillips, an assistant professor of health policy and administration at the University of Illinois Chicago who studies alcohol and aging. * * *
    • “If you’re not currently drinking, don’t start,” Dr. Phillips said. And if you do drink, be honest with your doctor about your consumption, and do it in a safe environment, knowing that your tolerance may not be what it used to be, she added.
    • “The answer doesn’t have to be abstinence,” Dr. Nixon said. But healthy aging “probably does not include multiple drinks a day for most people.”
  • Gastroenterology Advisor lets us know, “Development of gallstones and metabolic disorders, including obesity, metabolic dysfunction-associated steatotic liver disease (MASLD), diabetes, and hypertension, are related, according to study results published in Journal of Digestive Diseases.”
    • “The study authors noted, “[W]e revealed a significant increase in the prevalence of gallstone disease in the United States over the past years, which was potentially linked to a rising occurrence of metabolic disorders.” However, they concluded, “Further studies are necessary to evaluate the causal relationship and the underlying mechanisms involved in these conditions.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • The [One Big Beautiful] bill reduces the power of states to boost Medicaid payments to hospitals. 
    • States have increasingly imposed taxes on hospitals to trigger Medicaid matching funds from the federal government. Hospitals would typically balk at such levies, but in this case hospitals typically get back more money than they pay out in the form of higher payment rates.
    • The megabill reduces the maximum tax rate from 6% of hospitals’ net patient revenue to 3.5% in the 40 states that have expanded Medicaid under the Affordable Care Act. Nonexpansion states will have their state “provider taxes” frozen in place at the time the bill is signed.
  • This is excerpted from a Journal article about corporate winners and losers from enactment of the One Big Beautiful bill.
  • The Journal also discusses “what Trump’s Megabill means for you. How parents, retirees, tipped workers, Medicaid recipients and more will be affected.”
  • Per Beckers Hospital Review,
    • “Hospital and health system margins have stabilized for the moment, but a variety of factors could change that in coming months.
    • “Data from Strata Decision Technology, which gathers information monthly from more than 1,600 hospitals, found health system operating margins were around 1% for the fifth consecutive month in May while hospital margins grew by less than 1%. Hospitals in the West and Midwest reported slight margin declines while hospitals in the South reported 3.6 percentage points gained in average margins; hospitals in the Northeast reported 1.3 percentage point gains.
    • “Hospital size matters as well. Hospitals with 300-499 beds reported average margin increase of 2.6 percentage points while larger hospitals of 500 beds or more reported a 2.6 percentage point average margin decrease in May. The average margin for hospitals with less than 25 beds dropped 3.3 percentage points.
    • “Gross hospital revenue grew consistently as well, but gains were offset by increased expenses. Overall expenses were up nationwide year over year, driven by higher drug costs. Average total drug expenses increased 8.7% over the last year. Month over month, drug expenses jumped 0.7% while other non-labor expenses decreased slightly.”
  • and
    • lists the 18 hospital and emergency department closures in 2025 about which Beckers has reported. Most recently,
      • “St. Louis-based St. Luke’s Des Peres Hospital, a 143-bed acute care facility, will close on Aug. 1 due to low utilization and increased financial pressures.
      • “Stilwell (Okla.) Memorial Hospital and its clinic shuttered, ABC affiliate KTUL reported June 21. An employee told the news outlet the hospital will close June 27 and the clinic will shut down 30 days later.”