FEHBlog

Monday report

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Federal News Network discusses OPM recent hiring reforms, including last Friday’s Rule of Many.
  • Here’s a link to OPM’s fact sheet on the Rule of Many.
  • FedSmith recommends the FEHB and PSHB enrollees and covered family member “have your annual physical ahead of the Health Care Open Season” which starts in early November. Doing so allows the enrollee to “review health changes and update your FEHB coverage.” Intriguing idea.
  • Per a Congressional news release,
    • “Nearly five years after the No Surprises Act (NSA) was signed into law, delays and inconsistent rulemaking by Biden-era regulators have resulted in a patchwork system that fails to provide the transparency and protection for patients that Congress intended. In a letter to Secretaries of the Departments of Health and Human Services, Treasury, and Labor, Ways and Means Committee Republicans urged the Trump Administration to build on its previous work and the work of Congress and successfully implement the crucial patient protections provided under the No Surprises Act.
      • “The [Ways and Means] Committee is the first and only congressional committee to hold hearings examining challenges cited by patients and other stakeholders regarding the NSA’s implementation… Nearly five years after the NSA’s passage, and spanning multiple administrations, many of these identified challenges remain unresolved… We look to this Administration to continue building on the work done by the Committee to prioritize necessary regulatory and sub-regulatory improvements so patients can realize the full potential and benefits of the NSA,” wrote Committee members.”
  • In the FEHBlog’s view, patients are reaping the benefits of the NSA while health plans are getting the short end of the stick. The federal government should take steps to improve the arbitration process.
  • The American Hospital Association News tells us
    • “The Federal Trade Commission Sept. 5 voted 3-1 to vacate the noncompete final rule issued last year by the previous administration. The rule banned, as an unfair method of competition, contractual terms prohibiting workers from pursuing certain employment after their contract with an employer ends.” * * * 
    • “The FTC Sept. 4 issued a request for information on noncompete agreements, saying it seeks to “better understand the scope, prevalence, and effects of employer noncompete agreements, as well as to gather information to inform possible future enforcement actions.” 
  • and
    • “The White House Sept. 5 issued an executive order modifying the scope of reciprocal tariffs announced in April to establish a framework of trade deals with international partners on certain goods such as critical minerals and pharmaceutical products.   
    • “The order established a Potential Tariff Adjustments for Aligned Partners Annex, consisting of a list of products to which President Trump would be willing to apply the “most favored nation” tariff, pending any future reciprocal trade deal. Pharmaceuticals and their ingredients were one of four product categories listed.”

From the Food and Drug Administration front,

  • Reuters reports,
    • “The U.S. Food and Drug Administration is tightening oversight of imports of GLP-1 drug ingredients, used for weight loss and diabetes, amid concerns that many of the items may be adulterated and pose a safety risk.
    • “The move comes as the FDA cracks down on unapproved compounded drugs, which had filled the gap during shortages of patented treatments. Soaring demand for Novo Nordisk (NOVOb.CO), opens new tab and Eli Lilly’s (LLY.N), opens new tab obesity drugs has fueled a booming global market for cheaper, and sometimes even counterfeit versions.”
  • STAT News informs us,
    • “On Monday, eGenesis, a Cambridge-based biotechnology company, announced that it had been cleared by the Food and Drug Administration to begin a trial of kidneys from donor pigs that have been CRISPR’d to make their organs more human-friendly. Now, Massachusetts researchers will be performing more surgeries like [Bill] Stewart’s to see whether these animal parts could serve as a lifeline for people with end-stage renal disease.
    • “It’s the latest advance in a scientific swine race some hope might solve America’s organ shortage.” * * *
    • “Meanwhile, Revivicor, a subsidiary of Maryland-based United Therapeutics, has been trying its own porcine organs — including the first pig-to-human heart and kidney transplants — from animals with fewer genetic modifications. In February, United Therapeutics got the okay from the FDA to begin a clinical trial of its so-called “UKidney.” A spokesperson told STAT the company is “at least a month away” from performing the first transplant of the trial.”

From the judicial front,

  • Bloomberg Law reports,
    • “Top pharmacy benefit managers UnitedHealth Group Inc., Express Scripts Inc., and CVS Caremark notched a win after a federal judge partially dismissed certain class action claims that they conspired in an unfair pricing scheme for insulin products.
    • “The claims by the plaintiffs, which included self-funded payors and state attorneys general, are barred by an indirect purchaser rule and certain state laws, Judge Brian Martinotti for the US District Court for the District of New Jersey said in an order filed Sept. 5.” * * *
    • “Because the claims are barred by the indirect purchaser rule, the court is compelled to dismiss the civil claims under the Racketeer Influenced and Corrupt Organizations Act, Martinotti said.” * * *
    • “The order, however, denied the PBMs’ motion to dismiss the plaintiff’s unjust enrichment claims under Illinois law. “Unjust enrichment under Illinois law is not prevented by the indirect purchaser rule, and therefore, SFP Plaintiffs’ unjust enrichment claims in Illinois are sustained,” Martinotti said.”
  • Healthcare Dive relates,
    • “A federal judge dismissed several claims in the high-profile antitrust lawsuit against electronic health record giant Epic on Friday, but allowed other allegations by startup Particle Health to continue.
    • “Last year, Particle sued the EHR vendor, arguing Epic had used its large market share to crush competition in tools for payers. Epic filed a motion to dismiss the suit in December. 
    • “The judge agreed with Epic on five of the nine claims, dismissing Particle’s assertions that the vendor had maintained a conspiracy to uphold its market dominance, as well as claims of defamation and trade libel. However, the court declined to throw out three federal antitrust claims and Particle’s allegation that Epic had interfered with a business contract.” 
  • Per Federal News Network,
    • “A federal appeals court is ordering the dismissal of a case led by a group of states challenging the Trump administration’s termination of probationary federal employees, striking a significant blow to one of the two major cases that had challenged this year’s efforts to downsize the workforce by firing probationary workers en masse.
    • “Nineteen states and the District of Columbia filed the lawsuit in March, arguing that widespread firings at many agencies led to a sharp increase in unemployment claims and other sudden pressure on state budgets.
    • “In some cases, states said they had to expend “substantial resources” —sometimes creating new websites or opening new phone lines — to handle the volume of unemployment claims coming from fired probationary employees.
    • “But the U.S. Court of Appeals for the Fourth Circuit ruled in a 2-1 opinion on Monday that the plaintiffs “failed to allege a cognizable and redressable injury” from the widespread terminations.”

From the public health and medical/Rx research front,

  • Genetic Engineering and Biotechnology News reports,
    • “The global pandemic may be over, but SARS-CoV-2 continues to infect people around the world. Indeed, the United States has recorded roughly 750 deaths from COVID-19 over the past month.
    • “Now, an siRNA screen performed by scientists at Scripps Research has pinpointed dozens of human proteins that SARS-CoV-2 uses to complete its replication cycle. These findings could open the door to new drugs that target host proteins rather than the virus. This strategy may lead to new treatments effective against SARS-CoV-2 and other coronaviruses, even as the pathogens continue to evolve.
    • “This work is published in PLOS Biology in the paper, “Global siRNA screen identifies human host factors critical for SARS-CoV-2 replication and late stages of infection.”
  • BioPharma Dive adds,
    • “Pfizer and partner BioNTech said Monday their updated COVID-19 booster spurred strong immune responses against currently circulating coronavirus strains in late-stage testing, adding a key piece of evidence in support of the recently approved shot.
    • “According to Pfizer and BioNTech, the booster led to at least a four-fold increase in levels of LP.8.1-neutralizing antibody titers in a study cohort of people either over 65 or who are between 18 and 64 and have an underlying health condition. No new safety concerns were identified.
    • “The two companies ran the study to provide to the Food and Drug Administration additional information about the vaccine’s immunological impact. The results have been submitted to the agency, they said.”
  • Medscape notes that long Covid has been hitting doctors and nurses hard.
  • Per a National Institute of Standard and Technology news release,
    • “A type of drug called monoclonal antibodies (mAbs) can halt the growth of breast tumors, block the effects of rheumatoid arthritis, and treat many other diseases, from leukemia and colon cancer to asthma and osteoporosis. To manufacture these drugs, pharmaceutical companies genetically engineer living cells, grow those cells in large bioreactors, and harvest the mAb proteins that the cells produce.
    • “To support the manufacturing of these drugs, researchers at the National Institute of Standards and Technology (NIST) have collaborated with biotech company MilliporeSigma and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to develop a “living” reference material: specially tailored living cells that make mAbs with well-known properties.”
  • The American Medical Association lets us know what doctors wish parents knew about when to obtain emergency care for their children.
  • Per Healio,
    • “Individuals younger than 50 years with COPD faced an elevated risk for premature death and incident hospitalization/death due to chronic lower respiratory disease or heart failure, according to results published in NEJM Evidence.
    • “Clinicians can take away from our article that COPD is not uncommon in younger adults and should be considered as a possible diagnosis in young adults with 10 pack-years of smoking or respiratory symptoms,” Elizabeth C. Oelsner, MD, DrPH, general internist, respiratory epidemiologist, and Herbert Irving Associate Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, told Healio.
  • Per BioPharma Dive,
    • “BioNTech’s experimental bispecific cancer drug pumitamig helped shrink tumors in three-quarters of people with small cell lung cancer who were enrolled in a Phase 2 trial, and stabilized disease in all of them, the company said Monday.
    • “Company executives said the study’s results at an interim data checkpoint confirmed the dose it has selected for an ongoing Phase 3 trial with chemotherapy in the “extensive stage” form of the disease that can’t be treated with surgery or radiation. That trial may not have data until 2028.
    • “Pumitamig, also known by the code-name BNT327, is a drug targeting the PD-1 immune pathway and the cancer growth driver VEGF, a hotly contested area of biotech development. Opdivo maker Bristol Myers Squibb signed a deal with Germany-based BioNTech to co-develop pumitamig for $1.5 billion upfront and $2 billion a year through 2028.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The U.S. labor market is slowing, and job gains are largely in health services, which include healthcare and social services.
    • “Health services have been a consistent source of job growth, but impending Medicaid cuts could hinder the sector’s growth.
    • “There are concerns that Labor Department data might be overstating strength in health services, which could be revised lower.”
  • Fierce Health points out,
    • “Despite the hype about weight loss drugs known as GLP-1s, serious questions have remained about their efficacy when patients wean off the drugs.
    • “To date, studies have cast doubt on whether patients who stop taking the drugs can keep off the weight long-term. Some data suggest that those who discontinue regain between 14%and two-thirds of what they lost.
    • “But Omada Health, a virtual chronic care provider, is challenging the notion of inevitable weight gain with new data.
    • “When coupled with wraparound lifestyle support, 63% of Omada members maintained or continued to lose weight 12 months after discontinuing GLP-1s. At one year post-discontinuation, members showed just 0.8% average weight change. The analysis was based on 816 patients.”
  • Beckers Hospital Review informs us,
    • “Cleveland Clinic is expanding its presence in Florida with plans to build a $500 million hospital in West Palm Beach. The project will mark the system’s 24th hospital and significantly increase its footprint in Palm Beach County
    • “The hospital will be built on newly acquired land and comprise about 150 inpatient beds, an emergency department, a medical office building and an ambulatory surgery center.
    • “Palm Beach County has long been an area where we have planned to grow to enhance care for the community,” Cleveland Clinic President and CEO Tom Mihaljevic, MD, said in a Dec. 19 news release. “Our expansion plan will transform care for the community with a new hospital and outpatient clinics that provide a broad range of specialties, greater access and innovative patient experience programs.” 
  • BioPharma Dive reports,
    • “Drug developers from around the world rang in a new era of sleep medicine Monday, as data from a series of clinical trials show narcolepsy can be effectively treated by amplifying a specific brain protein.
    • “That protein, called orexin-2, helps regulate important body functions like appetite, arousal and wakefulness, which has in turn made it a promising target for drug companies. Johnson & Johnson, for instance, hopes that by blocking orexin-2, its experimental medicine seltorexant can be used to combat insomnia in patients with major depression.”
    • “More commonly, though, developers are looking to boost this protein to keep people with narcolepsy awake longer. The furthest along in this pursuit is Takeda Pharmaceutical with its drug oveporexton, which recently met the main and secondary goals of two late-stage clinical trials that focused on the most common, “Type 1” form of narcolepsy.
    • “On Monday, at a medical conference focused on sleep therapies, Takeda presented more detailed results from these studies.”
  • and
    • “Rapport Therapeutics’ market value doubled on Monday after the neurology-focused drugmaker unveiled mid-stage study results for an experimental seizure medicine that widely beat analyst and investor expectations.
    • “Treatment with Rapport’s drug, called RAP-219, reduced the frequency of clinical seizures by 78% versus the study’s baseline, a result that was matched by a similar reduction in electrographic seizure signs measured by a brain implant.
    • “As a result, Rapport said it plans to advance RAP-219 into two Phase 3 trials in the third quarter of next year. Shares in the company climbed by as much as 194% Monday morning to swell its capitalization above $1 billion”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of brensocatib (Brinsupri™, Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “NCFB is an incredibly burdensome condition with impacts that go well beyond its respiratory effects and include social, emotional, and productivity challenges,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “ICER’s analyses found that brensocatib, the first medication to be specifically indicated for NCFB, reduces the rate of pulmonary exacerbations and may also somewhat slow the rate of deterioration in lung function. Despite these benefits, however, we found that brensocatib’s expected discounted price was far out of alignment with the modest clinical improvements demonstrated in clinical studies. Pricing policy that balances innovation signals while addressing affordability and value will be an important topic at the public meeting.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on September 25, 2025. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

Weekend update

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

From Washington, DC

  • Beckers Payer Issues tells us,
    • “A group of House Republicans are backing the newly filed Bipartisan Premium Tax Credit Extension Act, which would extend enhanced ACA subsidies for one year beyond their current expiration date at the end of 2025.
    • “Under the legislation, the premium tax credits would expire Jan. 1, 2027. The bill would also maintain the expanded eligibility criteria that allows households earning more than 400% of the federal poverty level to qualify for subsidies.
    • “Insurers nationwide have requested a median 15% rate increase for 2026, citing both the anticipated expiration of the tax credits and rising medical costs. The tax credits, first expanded under the American Rescue Plan and extended by the Inflation Reduction Act, have helped drive record marketplace enrollment, with more than 24 million people signing up for coverage in 2025.
    • “The group of 10 Republican lawmakers supporting the bill is made up of some of the most politically vulnerable incumbents heading into the midterms, per Politico.”
  • The AP informs us,
    • “Republican senators say they are prepared to change the chamber’s rules to get around the Democratic blockade of President Donald Trump’s nominees and are discussing a proposal to make it easier to confirm multiple nominees at once.” * * *
    • “GOP senators discussed one proposal in a private meeting on Wednesday [September 3] that would enable them to confirm large tranches of nominees “en bloc,” or several at once, if a majority of senators agree, according to multiple senators who attended the meeting. 
    • “Currently, the objection of a single senator forces multiple votes on most nominations. The rules change would likely only apply to executive branch nominations, not lifetime judicial appointments, and would exclude many of the most high-profile positions, such as Cabinet nominees, that require a longer debate time.”
  • Here’s a link to the Federal Register’s PDF version of OPM’s September 8, 2025, final rule titled “Reinvigorating Merit-Based Hiring Through Candidate Ranking in the Competitive and Excepted Service (Rule of Many).” The rulemaking was first mentioned in last Friday’s FEHBlog.
  • HR discusses the Labor Department’s recently posted semi-annual regulatory agenda.
    • “The U.S. Department of Labor said Thursday it intends to revisit its overtime regulations under the Fair Labor Standards Act but did not disclose a deadline by which to issue an update on the subject, according to a press release.”

From the public health and medical/Rx research front,

  • The New York Times considers “Why Are More Older People Dying After Falls? Some researchers suspect that rising prescription drug use may explain a disturbing trend.”
    • “The Beers Criteria, a directory of drugs often deemed inadvisable for older adults, recently published recommendations for alternative medications and nonpharmacological treatments for frequent problems. Cognitive behavioral therapy for sleeplessness. Exercise, physical therapy and psychological interventions for pain.
    • “It’s a real tragedy when people have this life-altering event,” Dr. Steinman, co-chair of the Beers panel on alternatives, said of falls. He urged older patients to raise the issue of fall risk increasing drugs (FRIDs) themselves, if their doctors haven’t.
    • “Ask, ‘Do any of my medications increase the risk of falls? Is there an alternative treatment?’” he suggested. “Being an informed patient or caregiver can put this on the agenda. Otherwise, it might not come up.”
  • NPR Shots reports,
    • “By age 40, more than half of Americans have high blood pressure, but many are unaware of it. Hypertension has long been known as the silent killer. When it’s left untreated it can be deadly. And it’s considered a silent threat since most people have no symptoms. You can’t feel the pressure in your blood vessels increasing.
    • New recommendations from the American Heart Association aim for early treatment, including lifestyle changes and medications, once systolic blood pressure rises above 130/80 mm Hg, (which stands for millimeters of mercury, a measure of pressure). Experts say it’s clear that the sooner you take action, the more you can protect yourself.
  • Medscape lets us know,
    • “The proportion of patients taking a GLP-1 weight-loss drug following bariatric surgery increased substantially in recent years, although the timing of initiation after surgery varied widely, a large retrospective cohort study showed.
    • “GLP-1 initiation was also more common among women, those who underwent sleeve gastrectomy, and those with lower postoperative weight loss as measured by BMI.
    • “Some patients do not lose as much weight as expected, or they regain weight after a few years. In such cases, GLP-1 therapies are emerging as an important option for weight management,” said principal investigator Hemalkumar Mehta, PhD, associate professor at Johns Hopkins Bloomberg School of Public Health in Baltimore.”
  • and
    • identifies natural remedies for folks with gastrointestinal issues.
      • “Almost two thirds of Americans are burdened by gastrointestinal (GI) symptoms like heartburn, abdominal pain, bloating, diarrhea, and constipation. And for almost 40% of Americans, uncomfortable bowel symptoms are bad enough that they forgo routine activities such as exercising or spending time with their families.
      • “Medications, both over the counter and prescription, targeting GI conditions are plentiful. Yet more and more patients are requesting natural routes to relief, doctors told Medscape Medical News, and it’s likely your patients are, too.
      • “Here are some examples from doctors on how they’ve integrated natural remedies into their practice for specific common complaints. Some remedies have published research to back them up, while others are anecdotal, but backed by patients and doctors reporting that they do work.”
  • Per Fierce Pharma,
    • “Industry watchers who cheered on Summit Therapeutics’ claim that the first global phase 3 trial of its Akeso-partnered PD-1xVEGF [cancer] drug showed consistent benefit between China and Western populations may be disappointed, although hopes for an approval remain alive thanks to newly calculated patient survival data from a longer follow-up.”
  • and
    • “Facing increased EGFR [mutation] competition from a new drug combination by Johnson & Johnson, AstraZeneca has come up with its own solution to prolong the lives of patients who take the company’s decade-old medicine Tagrisso.
    • “The method involves pairing Tagrisso with chemotherapy. The combo significantly reduced the risk of death by 23% compared with Tagrisso alone in patients with previously untreated EGFR-mutated advanced non-small cell lung cancer, an updated analysis of the phase 3 Flaura2 trial has found.
    • “Patients who received Tagrisso and chemo lived a median 47.5 months, versus 37.6 months for the Tagrisso monotherapy group, according to data presented at the 2025 World Conference on Lung Cancer in Barcelona, Spain.
    • “The latest data drop helps re-level the playing field for Tagrisso after J&J’s combination of Rybrevant and Lazcluze recently became the first regimen to demonstrate an overall survival benefit against Tagrisso in first-line EGFR-mutated NSCLC.”

From the U.S. healthcare business front,

  • Medical Economics shares a slideshow about “health care spending per person in the 12 states where it is highest.”
  • Beckers Payer Issues points out,
    • “For more than two years, Becker’s has reported on the intensifying trend of Medicare Advantage reimbursement fights between hospitals and insurers that has contributed to a dizzying and ever-changing environment for older adults to navigate each enrollment period. 
    • “Now, that environment is experiencing more upheaval as the nation’s largest insurers pull backfrom Medicare Advantage markets to protect profit margins amid new federal cost-containment measures and rising medical expenses.
    • “This retrenchment is not entirely new, with some regional and mid-sized health plans scaling back their MA offerings for 2025 coverage. But with the biggest players now also making cuts, the ripples are getting bigger, and a wave of market exits and membership losses are reshaping the program for 2026.” * * *
    • “As national players retreat, some nonprofit and provider-owned MA plans are moving to make up ground that’s been lost in recent years. BCBS Wyoming, SCAN Health Plan, and WVU Medicine’s Peak Health have announced plans to launch or expand within the program for 2026, for instance.”
  • Fierce Pharma notes,
    • “Specialty and orphan drugs continue to dominate the development pipeline, and a new report from Optum Rx spotlights three products payers should be watching.
    • “The pharmacy benefit manager recently released its summer Notable New Drugs report, highlighting three products: Brinsupri (brensocatib), tolebrutinib and a subcutaneous version of Leqembi (lecanemab-irmb). All three are specialty drugs that aim to treat chronic conditions—non-cystic fibrosis bronchiectasis, multiple sclerosis and Alzheimer’s disease, respectively.
    • “Arash Sadeghi, senior clinical pharmacist on OptumRx’s pipeline and drug surveillance team, told Fierce Healthcare that specialty products represent between 70% and 75% of novel drugs approved each year, making it critical for health plans to monitor what’s coming to market.
    • “Any time we talk about the pipeline or drugs that are going to be high impact or blockbusters, so much of that time is devoted to specialty products, specifically,” Sadeghi said.”
  • Per Kaufman Hall,
    • “One-third of discharged patients go to a different hospital when requiring a readmission, according to data from Vizient’s CMS Qualified Entity Public Report, published last month. The highest proportion of different-hospital readmissions were for behavioral health (61.3%) and neurosciences (55.6%). Readmission rates were higher in urban areas (16.7%) than rural areas (15.4%), but rural patients were more likely to be readmitted to a different hospital, 35.1% vs. 32.3% for patients residing in urban areas. These “invisible returns” complicate care coordination and outcome tracking. Such fragmentation disproportionately affects high-risk populations, particularly those in vulnerable areas (as measured by the Vizient Vulnerability Index) and those covered by Medicaid or Medicare. The implications for patient retention are clear: if patients aren’t satisfied with the treatment at your hospital, they’ll go somewhere else.”
  • The Wall Street Journal reports,
    • “How much would you invest in the possibility of living to 150 or beyond? Or having 20 extra healthy years?
    • “For the ultrawealthy, it’s more than $5 billion over the past 2½ decades, according to a Wall Street Journal analysis of longevity investment deals in PitchBook, public company statements and regulatory filings.
    • “Silicon Valley giants Peter Thiel, Sam Altman, Yuri Milner and Marc Andreessen are among the boldface names behind the influx of money in the longevity industry. Thiel’s quest for longer life spans nearly a dozen companies—some of which were funded by his venture firm and others by a nonprofit foundation he backed—that raised more than $700 million, according to the Journal’s analysis.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

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

From the cybersecurity vulnerabilities and breaches front,

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

From the ransomware front,

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

From the cybersecurity defenses and business front,

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

Friday report

David Ermer–ACA, CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • This week’s blog post from OPM Director Scott Kupor concerns the value of incentives.
    • “Charlie Munger wasn’t talking about the federal General Schedule (GS) pay scale when he addressed a 1995 Harvard crowd on the critical role that incentives play in driving employee behavior, but he may as well have been. Because, unfortunately, 30 years later, his premonition remains true: how we pay federal employees remains one of the most critical – and backward – drivers of employee behavior.”
  • Bloomberg Law tells us,
    • “The Trump administration is rewriting the playbook for government hiring, allowing managers to select from a broader list of qualified candidates instead of having to choose from the top three scorers on a competitive exam.
    • “The new rule replaces the “rule of three,” under which civil service examiners narrow down a list of qualified applicants for a position while still giving the president and other senior officials the final say.
    • “The change will give hiring managers more latitude on which job candidates they exclude, allowing them to eliminate applicants if they’re passed over more than three times for the same position.’
  • Federal News Network informs us,
    • “Just three federal agencies, when combined, make up more than half of the total federal workforce reductions that have occurred so far under the Trump administration.
    • “The departments of Defense, Treasury and Agriculture have cut their staffing levels this year by a cumulative total of about 106,000 employees, according to data compiled by the non-profit Partnership for Public Service. That’s out of an estimated 199,000 federal employees governmentwide who have left their jobs since January, either voluntarily or by force.
    • “In terms of scale, the Defense Department has lost the most at 55,000 employees. The Treasury Department follows just after DoD with a loss of 30,000 employees — mostly from the IRS. And the Agriculture Department has 21,000 fewer employees, the Partnership found in its data report, which compiles findings from agency documents and media reports.”
  • Govexec considers how yesterday’s semi-annual regulatory agenda could impact federal employees.
  • STAT News reports,
    • “The Food and Drug Administration is now publishing complete response letters to drugmakers shortly after they are issued, marking a major shift in transparency into regulation by the agency. Yesterday, the FDA disclosed 89 previously unreleased CRLs from 2024 and 2025, including rejections for Replimune, Capricor Therapeutics, and Ultragenyx.
    • “Traditionally, it’s been up to companies to disclose the reasons for an FDA rejection, a process that critics contend can lead drugmakers to misrepresent what the agency said. In July, the agency announced its intention to release letters in “real time,” and published a batch of letters for drugs that had eventually won approval. Yesterday’s release went beyond that.”
  • The FDA adds, “Decision letters are accessible to the public as a centralized dataset at openFDA.”

From the public health and medical/Rx research front,

  • The Centers for Disease and Prevention announced today,
    • “COVID-19 activity is peaking in many areas of the country with elevated emergency department visits and hospitalizations nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is peaking nationally. Emergency department visits for COVID-19 are elevated in children 0-4 and 5-17 years old. Hospitalizations are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • ‘RSV activity is very low.
    • “Vaccination
      • “RSV immunization products will be available beginning in September across most of the continental United States. To protect against RSV-associated lower respiratory tract infections, all infants should receive either maternal RSV vaccination during pregnancy or a long-acting RSV monoclonal antibody, nirsevimab or clesrovimab.
      • “A CDC MMWR report published on August 28, 2025, outlines recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the use of clesrovimab for preventing severe RSV-related illness in infants. Clesrovimab could further increase access to and protection for infants in the 2025–26 respiratory virus season.”
  • Beckers Hospital Review points out steps that states are taking to override the FDA’s limited Covid vaccination recommendation which the CDC’s Advisory Committee on Immunization Practices (ACIP) will take up at a September 18-19 meeting.
  • Beckers Payer Issues adds that the “Massachusetts’ Division of Insurance and Department of Public Health has issued a bulletin Sept. 3 requiring insurance carriers to cover vaccines as outlined by the state, not just the CDC.”
  • The University of Minnesota’s CIDRAP lets us know,
    • “In a weekly update, the US Centers for Disease Control and Prevention (CDC) today [September 3] reported 23 more measles cases, lifting the country’s total to 1,431, the most since the country reached elimination status in 2000.
    • “For the first time, health officials divided out the cases confirmed in international visitors, which account for 18 of the national cases.
    • “The number of outbreaks remained the same, at 35, double the number for 2024. So far, 86% of cases are linked to outbreaks, compared to 69% last year. To date, 92% of patients were unvaccinated or have an unknown vaccination status. School-age kids are the most affected group, followed closely by adults ages 20 years and older.”
  • The New York Times identifies “6 More Things E.R. Doctors Wish You’d Avoid. Stay out of the emergency room with these tips.
    • “Last winter, I wrote about things emergency room doctors wish you’d avoid, and many more E.R. doctors wrote in to tell me what I had missed.”
      • “Never put your feet on the dashboard.
      • “Don’t forget your eyes when doing yardwork.
      • “And never mow the lawn in open-toed shoes.
      • “Watch out for the front burner.
      • “If you’re choking, forget about privacy.
      • “Don’t take another person’s prescription medication.”
  • The American Hospital Association News notes,
    • “A Health Affairs study published Sept. 2 found that less than 40% of Medicare beneficiaries with opioid use disorder received standard care in alignment with quality measures. Researchers analyzed Medicare enrollment, claims and encounter data to assess the extent to which beneficiaries with OUD received treatment in alignment with eight nationally recognized quality measures in 2020. The study found that Medicare Advantage performed worse than fee-for-service Medicare on six of eight measures, and that Medicare performed worse than Medicaid on all three comparable OUD quality measures available.
    • “The authors said a variety of initiatives could be used to improve OUD treatment for Medicare beneficiaries, including enhanced Medicare coverage, policies enabling more providers to treat beneficiaries with OUD, policies and programs to facilitate care connections following hospitalization or an emergency department visit, and initiatives encouraging beneficiaries to seek treatment.”
  • Medscape explains “Everything Patients Need to Know About Aging on GLP-1s.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CVS Health is tapping into health system partnerships as it rapidly expands primary care offerings.
    • “CVS has added primary care services at more than 400 MinuteClinic sites across 12 states and Washington, D.C., in the last year or so, said Dr. Creagh Milford, interim president of retail health at CVS Health and president at CVS-owned Oak Street Health. The goal is to offer primary care at all MinuteClinic sites and build a payer-agnostic network to serve patients, he said.
    • “However, the strategy requires buy-in from residents, which isn’t a guarantee in all communities.
    • “The healthcare conglomerate has formed primary care clinical affiliations with three health systems to help with the primary care shift and is looking for more partners. Milford said several dozen conversations are underway about similar agreements. 
    • “We’re seeing a lot of traction,” Milford said. “One of the things that had been a challenge between MinuteClinic and our health system partners is, how do we better coordinate care?” 
    • “The clinical affiliations are another way for health systems to respond to physician shortages and expand access to care.
    • “CVS’ first primary care-driven affiliation was with Atlanta-based Emory Healthcare Network, which was announced in February. As part of the agreement, MinuteClinic offers in-network adult primary care at all 35 clinics in Georgia to most payers through Emory’s integrated network.” 
  • Per Cardiovascular Business,
    • “Congenital heart disease surgical procedures are relying more on 3D echocardiography as it is rapidly transforming the way congenital heart procedures are planned, guided and help manage patients afterwards. The technology is offering cardiac surgeons and interventional cardiologists clearer images, better communication, and safer procedures for even the smallest patients.
    • “3D echo captures the heart in real time and with the full structure of the heart. You can cut through with. So pre-surgical planning and it is now moving into the operating room. Because of the release of the pediatric 3D transesophageal echo (TEE) probes, we can characterize the valve tissues that the surgeons are repairing quite nicely,” explained Pei-Ni Jone, MD, FASE, director of the echocardiography laboratory at Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee.
    • “She said 3D echo offers a surgical view of the valve non-invasively and it can visualize valve failures that happen in the operating room or help determine if a surgeon needs to go back on bypass to repair something.”
  • Per MedTech Dive,
    • “A clinical trial of Medtronic’s Hugo robot has met its primary effectiveness and safety endpoints, the company said Thursday.
    • “Physicians used the robotic-assisted surgery system to treat 193 patients. All of the surgeries were successfully completed. Two people had surgical safety events in the 30 days after treatment that were resolved without complication. 
    • ‘Medtronic has filed for authorization of the system in a urology indication and plans to expand into hernia repair later. The company will compete with Intuitive Surgical for the hernia market.”
  • The American Journal of Managed Care notes,
    • “Rideshare transportation for abnormal [fecal immunochemical test] FIT results can double colonoscopy completion rates, reducing [colorectal cancer] CRC cases and deaths significantly.
    • “The intervention is cost-saving, generating more than $330,000 savings per 1000 people screened due to earlier cancer detection.
    • “Early FIT screening, starting between ages 40 and 49 years, is crucial as CRC rates rise among younger populations.
    • “The study’s microsimulation model projects long-term CRC outcomes, supporting further trials to validate rideshare intervention effectiveness.”

Thursday report

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

From Washington, DC,

  • Per a Congressional news release,
    • “[Yesterday,] the House Appropriations Committee met to consider the Fiscal Year 2026 Financial Services and General Government Appropriations Act. The measure was approved by the Committee with a vote of 35 to 28.”
    •  Among other provisions, the bill “prohibits the Federal Employees Health Benefit Program from covering puberty blockers, hormone therapy, or surgical procedures for gender affirming care.”
  • Healthcare Dive notes,
    • “At a House subcommittee hearing on Wednesday, lawmakers expressed concerns about whether artificial intelligence is being appropriately used in healthcare and called for stronger guardrails to supervise the quickly evolving technology.
    • “With all these innovative advancements being leveraged across the American healthcare ecosystem, it is paramount that we ensure proper oversight is being applied, because the application of AI and machine learning will only increase,” said Energy and Commerce subcommittee Chair, Rep. Morgan Griffith, R-Va.”
  • The Wall Street Journal reports,
    • “Health Secretary Kennedy faced bipartisan Senate [Finance Committee] questioning regarding CDC turmoil and changes to U.S. vaccine policy.
    • “Kennedy defended his actions as necessary to restore the CDC, while critics raised concerns about vaccine access and his appointees.
    • “The CDC is facing internal strife after the ouster of its director and calls for Kennedy’s resignation from employees.”
  • MedPage Today adds,
    • “HHS Secretary Robert F. Kennedy Jr. has chosen seven new members for the CDC’s Advisory Committee on Immunization Practices (ACIP), according to information obtained by MedPage Today‘s editor-in-chief Jeremy Faust, MD.
    • ACIP’s next meeting is set to take place Sept. 18-19, and the posted agenda states that “recommendation votes may be scheduled” for immunizations against hepatitis B, COVID, and respiratory syncytial virus, as well as the measles, mumps, rubella, and varicella shot.
  • STAT News tells us,
    • “After months of uncertainty, the Trump administration confirmed that it will work with Gilead Sciences and The Global Fund to Fight AIDS, Tuberculosis and Malaria to provide a groundbreaking HIV prevention drug to up to 2 million people in low- and middle-income countries.
    • “The ambitious effort was first announced late last year but doubts quickly emerged after the Trump administration began to drastically cut foreign aid. The move appeared to jeopardize the future of the President’s Emergency Plan for AIDS Relief, or PEPFAR, which has long been the world’s leading provider of HIV prevention drugs. Only about half of its $6 billion budget has reportedly been appropriated.
    • “Nonetheless, The Global Fund, which pools money from public and private donors, maintained it would proceed with plans to purchase and distribute the Gilead medication, called lenacapavir. The antiviral offers virtually complete protection against contracting HIV with just a single administration every six months and has been hailed as a tool that could bring the 45-year-old pandemic to heel.” 
  • and
    • “A key government study about alcohol and its health harms will not be released publicly, despite several years of taxpayer-funded work and a growing body of evidence connecting drinking with disease. 
    • “A final version of the Alcohol Intake and Health Study led by the Substance Abuse and Mental Health Services Administration will not be published, “to the detriment of the people’s health,” scientific review panelist Priscilla Martinez told STAT in an email Thursday morning. Another panel member confirmed that they have not heard from the Trump administration since submitting their work months ago. News of the killed report was first reported by Vox.”
  • The American Hospital News informs us,
    • “The Department of Health and Human Services Sept. 4 announced new hardship exemption guidance that would allow consumers ineligible for premium tax credits or cost-sharing reductions to enroll in catastrophic health coverage. Consumer eligibility will be based on projected annual household income. The Centers for Medicare & Medicaid Services made this change in light of the significant anticipated rise in individual market premiums and the expiration of the enhanced premium tax credits at the end of the year.”
  • Modern Healthcare relates,
    • “The Federal Trade Commission asked the public to weigh in on noncompete contract provisions, even though district courts have blocked the commission’s nationwide ban on most of those agreements. 
    • “The agency issued a request for information Thursday, seeking detail about employers who unfairly restrict employees from working for a rival organization through noncompetes. These agreements can stunt wage growth, limit competition, reduce innovation and inflate prices, the FTC said.
    • The commission said the consequences are magnified in healthcare where noncompete agreements can restrict patient access, particularly in rural areas. The comment period will close Nov. 3. 
  • Axios interviews OPM Director Scott Kupor.
    • Q “You’re nominated in December but not confirmed until July. In the meantime, Elon Musk and DOGE make lots of major personnel decisions via OPM. Were you just sitting on your hands?
    • A “The short answer is yes. That’s the rules. I wasn’t even allowed to go into the building, so I was just trying to interpret what was happening. The only time I got more insight was when I started prepping for the Senate confirmation hearing, because I got briefed so I wouldn’t look like a complete idiot.” * * *
    • Q You’ve also talked about establishing more of a merit-based system for federal workers. But DOGE often fired probationary workers, not because of merit but because of where they were on the totem poll.
    • A “It was only around 5,800 probationary employees out of 2.4 million across the entire government. Yes, I’m sure many of those were under 30, and the government has a real problem getting younger workers — only 7% under 30 compared to 24% in the normal workforce — but you still need to view it in context.”
    • Q Of that 2.4 million, how many do you want still working for the government at year-end?
    • A “Around 2.1 million, which is where we were when the first Trump administration took office … That doesn’t include the military, which OPM isn’t responsible for.”
  • FedSmith points out,
    • “The percentage of federal employees working on site has more than tripled from its low point of the last three years according to new data released by Gallup.
    • “The new Gallup poll data show that as of the second quarter of 2025, 46% of federal employees in Washington, DC now work fully on site. This is more than double the national average of 21% and more than triple the low point of 14% back in Q1 2022.
    • “Also, the percentage of federal employees working in a hybrid model (employees who work both on-site and remotely) dropped sharply since President Trump took office, going from 61% at the end of 2024 to 28% in Q2 2025.”
  • At long last, the Spring 2025 semi-annual regulatory and deregulatory agenda has appeared on reginfo.gov.
    • OPM agenda has one FEHB entry reading
      • “The Office of Personnel Management (OPM) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that would have amended the Federal Employees Health Benefits (FEHB) regulations at 5 CFR part 890 that would have allowed FEHB coverage to take effect at the beginning of the pay period that an employee in pay status has an initial opportunity to enroll. OPM is withdrawing the proposed rule as additional research determined that the potential costs to agencies for making updates to business systems and processes for an additional two weeks of FEHB coverage is not an effective use of resources.” 

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “Kardium has received premarket approval for its Globe pulsed field ablation system, as well as 510(k) clearances for both the Globe Introducer sheath and mapping software, the company said Wednesday. 
    • “The Food and Drug Administration authorization positions Kardium, which raised $250 million to fund commercialization in July, to launch the system as a treatment for atrial fibrillation.
    • “Kardium is entering a fast-growing market served by Boston Scientific, Johnson & Johnson and Medtronic. The company cited Boston Scientific and Medtronic devices as 510(k) predicates.”

From the public health and medical/Rx research front,

  • The New York Times fills us in about flu shots this fall.
  • Health Day reports,
    • “A single dose of RSV vaccine might protect seniors for two cold and flu seasons in a row, a new study says.
    • “Vaccination reduced seniors’ risk of hospitalization by 58% during two RSV seasons, researchers reported Aug. 30 in the Journal of the American Medical Association.
    • “These results clearly demonstrate that the RSV vaccines prevent hospitalizations and critical illness due to RSV infection among older Americans,” said principal investigator Dr. Wesley Self, senior vice president for clinical research at Vanderbilt University Medical Center in Nashville, Tennessee. “It is exciting to see the public health benefits of this new vaccination program.”
    • “However, the vaccine’s effectiveness waned between the first and second years, raising questions regarding how often seniors should get the jab.” * * *
    • “Redosing the vaccine at some interval after the initial dose could be a strategy to maintain protection over longer periods of time,” Self said. “It will be important to continue to closely monitor vaccine effectiveness over time to understand how long the benefit lasts after a single dose and if repeat dosing should be considered.”
  • Per Tech Target,
    • “One in six women have missed a routine cancer screening in the past year, underscoring deep care gaps imperiling health outcomes, according to new data obtained via email.
    • “The data, gleaned from the full dataset from the Prevent Cancer Foundation’s annual Early Detection Survey, showed that women tend to stay up to date on other ordinary tasks — like getting a haircut, renewing their driver’s license or donating their old clothes — more than their preventive cancer screenings.
    • “Instead, women mostly only schedule a preventive screening when they are experiencing the signs or symptoms of disease, with 33% of respondents saying as much.
    • “Early detection equals better outcomes, so we can’t wait until our bodies are screaming at us to check our health. Women need to prioritize their own health by going to the doctor even when everything feels fine,” Jody Hoyos, CEO of the Prevent Cancer Foundation, said in an emailed statement. “Routine checks and screenings provide an opportunity to stay ahead of cancer, so if there is an issue, you can deal with it before it becomes a bigger problem down the road.”
  • Per STAT News,
    • “One of the worst places for cancer can spread is the leptomeninges, the inner membranes encasing the brain and spine. Patients with these metastases have limited treatment options and tend to succumb to the disease rapidly. But a new study suggests that using proton beam therapy might make it possible to more effectively treat these cancers with radiation and dramatically extend survival.
    • “There’s so little we have to offer patients with leptomeningeal metastasis that really, truly works,” said Lauren Boreta, a radiation oncologist at the University of California San Francisco, who did not work on the study. Treatments that increase survival, the way this study showed proton beam radiation did, is “unheard of for these patients,” she said. “It’s shocking. We haven’t had an advance in this space for maybe ever.” * * *
  • The Washington Post explains “the health risks from plastics almost nobody knows about Phthalates, chemicals found in plastics, are linked to an array of problems, especially in pregnancy.”
  • Per MedTech Dive,
    • “Cardiologists are welcoming the arrival of a new device-based hypertension treatment called renal denervation and asking Medicare to cover the procedure for a large patient population.
    • “Doctors, medical groups and others have endorsed national reimbursement for renal denervation in dozens of public comments submitted to the Centers for Medicare and Medicaid Services ahead of a final Medicare coverage decision expected by early October. Many cite concern about the high numbers of patients whose blood pressure remains poorly controlled despite the availability of multiple drug treatments.” 
  • Genetic Engineering and Biotechnology News reports.
    • “A key to understanding the brain lies in unpacking how hundreds of interconnected brain areas process information that leads to various outputs. In order to try to understand this, researchers investigate both single neurons and groups of neurons together. Now, a major advance in this area of neuroscience study has been published: the first complete activity map of the brain has been unveiled by a large international collaboration of neuroscientists.
    • “Two papers published in Nature reveal insights into how decision-making unfolds across the entire brain in mice at the resolution of single cells. This brain-wide activity map shows that decision-making is distributed across many regions in a highly coordinated way.”
    • “This is the first time anyone has produced a full, brain-wide map of the activity of single neurons during decision-making,” explained Professor Alexandre Pouget, PhD, co-founder of the International Brain Laboratory (IBL) and group leader at the University of Geneva. “The scale is unprecedented as we recorded from over half a million neurons across mice in 12 labs, covering 279 brain areas, which together represent 95% of the mouse brain volume. The decision-making activity, and particularly reward, lit up the brain like a Christmas tree.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Employees of large and small companies are likely to face higher health care costs, with increases in premiums, bigger deductibles or co-pays, and will possibly lose some benefits next year, according to a large survey of companies nationwide that was released on Thursday.
    • “The survey of 1,700 companies, conducted by Mercer, a benefits consultant, indicated that employers are anticipating the sharpest increases in medical costs in about 15 years. Higher drug costs, rising hospital prices and greater demand for care are all contributing factors, experts said.
    • “With the projected increases, this is the fourth consecutive year in which employers — and their workers — have faced significantly higher costs for health insurance, with next year representing the biggest jump since 2010.” * * *
    • “Without making any changes to benefits — which would involve moves like shifting more costs to workers or reducing benefits — employers said they expected next year’s increases in health costs to reach nearly 9 percent on average. By altering plans, they projected increases overall of 6.5 percent on average in health costs next year.
    • “A quarter of those surveyed projected double-digit increases for 2026 even after changes to plans.”
  • Modern Healthcare relates,
    • “Elevance Health will cut some Medicare Advantage plans and fully exit the Medicare Part D standalone prescription drug market next year. 
    • “The for-profit Blue Cross and Blue Shield licensee will eliminate unprofitable Medicare Advantage plans covering approximately 150,000 individual and group members in total, Chief Financial Officer Mark Kaye said Thursday during the 2025 Wells Fargo Healthcare Conference. The company has prioritized HMO and Dual Special Needs Plan coverage for 2026, he said.
    • “Elevance Health is the fourth-largest Medicare Advantage carrier, with 2.3 million enrollees. It counts 400,000 standalone Part D members, making it the sixth-largest carrier, according to a July report by KFF, a healthcare research firm. It is one of seven companies that sell standalone Part D plans, KFF said. Fee-for-service Medicare beneficiaries purchase the coverage to help offset their prescription drug costs.” 
  • Beckers Payer Issues adds,
    • “UCare has asked CMS to mutually terminate its Medicare Advantage plans for 2026, citing rising medical costs and challenges within the broader market.
    • “This decision was not made lightly,” President and CEO Hilary Marden-Resnik said Sept. 4 “UCare remains deeply committed to the health of Minnesotans and to supporting members through upcoming transitions.”
    • “UCare has more than 600,000 members in Minnesota and parts of western Wisconsin, including 158,000 MA members. It is the second largest MA carrier in the market, with 26% percent market share. The company will continue to offer Medicaid, special needs plans, Medicare supplement and ACA coverage.”

Midweek report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Beckers Health IT informs us,
    • “Federal lawmakers have introduced a bill to extend Medicare telehealth flexibilities and CMS’ hospital-at-home waiver.
    • “The Telehealth Modernization Act of 2025 would prolong the telehealth program through Sept. 30, 2027, and CMS’ reimbursement of acute hospital care at home through 2030. The measures otherwise expire Sept. 30.
    • “Telehealth is a vital part of our healthcare system, and we must ensure that it is available to patients who need it,” said U.S. Rep. Earl “Buddy” Carter, R-Ga., in a Sept. 2 news release. “By extending telehealth flexibilities for patients, we are making healthcare more accessible, regardless of their physical location.”
    • “Mr. Carter introduced the House bill with Rep. Debbie Dingell, D-Mich., while a companion Senate bill is being led by Sens. Tim Scott, R-S.C., and Brian Schatz, D-Hawaii. Nearly 50 health systems have called for the telehealth extension.”
  • Federal News Network reports,
    • “The Office of Personnel Management is taking a closer look at the details for implementing President Donald Trump’s proposal for a larger pay raise for federal law enforcement personnel next year.
    • “The announcement from OPM comes a couple days after Trump called for a 3.8% pay raise in 2026 for federal employees working in law enforcement jobs.
    • “Certain frontline law enforcement personnel are critical to implementing the President’s strategy to secure the border, protect our country and keep American citizens safe,” OPM said this week in new guidance. “Without special salary rates, the government may find it difficult to recruit and/or retain the number of these personnel needed to properly enforce our borders, uphold our immigration laws and protect law-abiding citizens.”
    • “It’s not yet clear which specific positions or how many law enforcement officials will be included in the new special salary rate. OPM said it plans to consult with the departments of Homeland Security, Justice and Interior to define which jobs will be eligible for the larger law enforcement pay raise next year.
    • “Generally, though, OPM said the upcoming special salary rate will cover agents in the Border Patrol and the Drug Enforcement Administration, criminal investigators at Immigration and Customs Enforcement (ICE), Secret Service personnel, officers at the Federal Protective Service and the FBI, and correctional officers at the Federal Bureau of Prisons — among several other groups.”
  • and
    • “After unveiling a series of immediate acquisition changes over the summer, the Trump administration is on track to debut a formal rulemaking to overhaul and streamline the Federal Acquisition Regulation, or the FAR, this fall.
    • “Larry Allen, the associate administrator for General Services Administration’s Office of Government-wide Policy, discussed the ongoing FAR revisions and the forthcoming rulemaking during AFCEA Bethesda’s “Health IT” conference in Washington on Wednesday.
    • “Under an April executive order, the White House Office of Federal Procurement Policy and the FAR Council are leading an effort to “return the FAR to its statutory roots, rewritten in plain language, and remove most non-statutory rules.”
    • “In recent months, the FAR Council has issued a series of “class deviations” for multiple parts of the FAR. Recent deviations have focused on prioritizing the use of governmentwide contracts and simplifying commercial acquisition.” * * *
    • “In follow-up guidance to the executive order, the Office of Management and Budget said the FAR Council will turn to formal rulemaking after it has posted model deviations for all FAR parts.”
  • It’s worth adding that reginfo.gov no longer carries an “under repair” warning and while the regulatory review pages are up to date, the regulatory agenda page still features the Fall 2024 edition.
  • Govexec considers whether FEGLI Option B is really the best life insurance choice? FEGLI plans remain a solid life insurance option for federal employees, but, depending on the coverage, it may also be wise to look to the private market.
  • Following up on yesterday’s FEHBlog, Beckers Hospital Review notes,
    • “A federal rule enabling real-time access to prescription drug pricing, coverage details and prior authorization requirements is set to take effect Oct. 1. 
    • “The regulation, finalized in July as part of the CMS Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System final rule, will require healthcare providers to use certified health IT systems to electronically submit prior authorization requests, check real-time prescription drug pricing during patient encounters and share electronic prescription data with pharmacies and insurers.”
  • Fierce Healthcare adds,
    • “The Department of Health and Human Services’ investigation unit and health IT offices are stepping up enforcement of information blocking committed by providers, health IT developers and health information exchanges, the department announced Wednesday. 
    • “The news comes as Trump’s HHS is trying to improve the flow of patient health information by securing voluntary commitments by 60 major healthcare and tech companies to advance interoperability. 
    • “A press release by HHS says Health Secretary Robert F. Kennedy Jr. has “directed increased resources” to investigate and enforce information blocking rules.
    • “The Office of the Assistant Secretary for Technology Policy (ASTP/ONC) has already begun to review reports of information blocking and provide technical assistance to HHS’ Office of the Inspector General to assist their investigations, Assistant Secretary Thomas Keane said in a statement.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect. Through the RDEP process, sponsors will receive clearer guidance on the types of evidence that can be used to demonstrate substantial evidence of effectiveness.
    • “Drug developers – and the patients they hope to treat – deserve clear, consistent information from the FDA,” said FDA Commissioner Marty Makary, M.D., M.P.H.  “These principles ensure that FDA and sponsors are aligned on a flexible, common-sense approach within our existing authorities, and that we incorporate confirmatory evidence to give sponsors a clear, rigorous path to bring safe and effective treatments to those who need them most.”    
  • BioPharma Dive reports,
    • “Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also the company’s first commercial product since it sold off its main revenue driver a few years ago.
    • “After some delays, the Food and Drug Administration is set to issue an approval verdict on this medicine sometime between October and the end of December. If cleared for market, the oral drug would be sold as Vyglxia and used to treat patients with spinocerebellar ataxia, a type of genetic disorder where the progressive erosion of nerve cells causes problems with movement, coordination and brain function.”
  • Per MedTech Dive,
    • “Medtronic has received an expanded label from the Food and Drug Administration to pair its MiniMed 780G insulin pump with a glucose sensor being developed by Abbott for Medtronic.
    • “Medtronic and Abbott will submit required compliance documentation for sensor integration and marketing in the coming weeks, finishing the regulatory process, the companies announced Tuesday.
    • “The FDA decision also expands the insulin pump to adults with Type 2 diabetes.”

From the public health and medical/Rx research front,

  • The American Hospital News tells us,
    • “The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory syncytial virus this upcoming respiratory virus season compared to last year’s, according to its 2025-26 outlook released Aug. 25. The agency is predicting higher peak weekly COVID-19 hospitalization rates this season, particularly if a variant with moderate immune-escape properties emerges.”
  • and
    • “The AHA Sept. 3 released a study conducted by KNG Health Consulting that found Medicare patients who receive care in a hospital outpatient department are more likely to come from geographically isolated and medically underserved communities and be sicker and more complex to treat than Medicare patients treated in independent physician offices. Specifically, the study found that Medicare patients who are seen in HOPDs — including those with cancer — are more likely to be from rural and lower-income areas, living with more severe chronic conditions, dually-eligible for both Medicare and Medicaid, previously hospitalized or cared for in a hospital emergency department, and under 65 and eligible for Medicare based on disability.”
  • The Wall Street Journal discusses how to get the new Covid vaccine.
  • NBC News adds,
    • “An over-the-counter nasal spray which has been used for years as a safe and effective treatment for seasonal allergies could potentially prevent Covid infections, according to clinical trial results released Tuesday.
    • “The antihistamine azelastine works as an antiviral against a range of respiratory infections, including influenza, RSV and the virus that causes Covid, a growing number of studies have shown.” * * *
    • “Our findings suggest azelastine could serve as a scalable, over-the-counter prophylactic against Covid, especially when community transmission is elevated or in high-risk settings such as crowded indoor events or travelling,” said Dr. Robert Bals, professor of internal medicine and pneumology at Saarland University and the study’s senior author.
    • “The trial had limitations, namely that the participants were all young and relatively healthy, he said. 
    • “Bals said that azelastine should not be seen as a replacement for vaccinations, and larger studies were needed before recommending it as a routine preventative measure for the general public, and especially vulnerable groups.”
  • Per a National Institutes of Health news release,
    • “Researchers funded by the National Institutes of Health (NIH) have found that a single injection of the antibiotic benzathine penicillin G (BPG) successfully treated early syphilis just as well as the three-injection regimen used by many clinicians in the United States and elsewhere. These findings from a late-stage clinical trial suggest the second and third doses of conventional BPG therapy do not provide a health benefit. The results were published today in The New England Journal of Medicine.
    • “Benzathine penicillin G is highly effective against syphilis, but the three-dose regimen can be burdensome and deter people from attending follow-up visits with their healthcare providers,” said Carolyn Deal, Ph.D., chief of the enteric and sexually transmitted infections branch of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “The new findings offer welcome evidence for potentially simplifying treatment with an equally effective one-dose regimen, particularly while syphilis rates remain alarmingly high.”
    • “Syphilis is a common sexually transmitted infection (STI) caused by the bacterium Treponema pallidum. The United States reported 209,253 total syphilis cases and 3,882 congenital syphilis cases in 2023, representing 61% and 108% increases over 2019 numbers, respectively. Without treatment, syphilis can result in neurological and organ damage as well as severe pregnancy complications and congenital abnormalities. Syphilis can also increase a person’s likelihood of acquiring or transmitting HIV.
    • “BPG is one of the few antibiotics known to effectively treat syphilis, and stockouts are common worldwide. The antibiotic is currently being imported to the United States to resolve a nationwide shortage.”
  • Per Beckers Hospital Review,
    • “Researchers have successfully used repurposed cancer drugs to target dormant breast cancer cells, aiding in the delay or prevention of recurrence, according to a study published Sept. 2 in Nature Medicine. 
    • “Researchers from Philadelphia-based University of Pennsylvania’s Abramson Cancer Center and Perelman School of Medicine enrolled 51 breast cancer survivors to identify and target the cells with existing cancer drugs.” * * *
    • “Read the full study here.” 
  • Per Healio,
    • “Nonsurgical treatments may offer long-term reductions in pain and disability for patients with chronic low back pain.
    • “Treatment options included cognitive behavioral therapy, mindfulness and exercise.”
  • Per Health Day,
    • “Guidelines recommend that preschoolers diagnosed with ADHD first get six months of behavioral therapy before drug therapy is initiated
    • “New research shows this rule is followed by U.S. doctors only about 14% of the time, and that could mean poorer outcomes for kids
    • “A lack of access to therapists is often cited as a reason for starting meds soon, but experts say there are ways around that.”

From the U.S. healthcare business front,

  • Fierce Pharma points out,
    • “After joining multiple other drugmakers on the U.S. investment bandwagon earlier this year, Gilead Sciences is providing further details on where it plans to channel its $32 billion pledge.
    • “Gilead has broken ground on a new pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, the company said Tuesday.
    • “The new facility, which will reach five stories and cover 180,000 square feet, will serve the company’s technical development and manufacturing teams, leveraging a mix of digitalization, autonomous robotics and real-time digital monitoring. Additionally, the project is expected to boost Gilead’s capabilities and capacity around biologics, which the company described as a “central pillar” of its broader growth strategy.”
  • Beckers Hospital Review lets us know,
    • “Cincinnati-based TriHealth has completed the acquisition of Clinton Memorial Hospital, a 140-bed facility in Wilmington, Ohio, marking its sixth acute care hospital.
    • “The facility will be renamed TriHealth Clinton Regional Hospital and serve as a hub for the system’s specialized services, including women’s health, cancer, heart and vascular, neurosciences and stroke care.
    • “This new name will extend TriHealth’s brand promise to ‘see, to hear and to heal … delivering surprisingly human care’ to the residents of Clinton County,” TriHealth President and CEO Mark Clement said in a Sept. 2 news release. “And it will also affirm TriHealth’s commitment to invest in the hospital and expand services locally, establishing it as a regional hub for TriHealth’s exceptional, nationally recognized care.”
  • Fierce Healthcare reports,
    • “HonorHealth, an Arizona-based health system, is acquiring a number of Evernorth Care Group locations across Phoenix.
    • “Evernorth Care Group lists 18 centers offering integrated primary care services to nearly 80,000 patients throughout the metropolitan area. The clinics will become part of HonorHealth at the close of the deal, slated for January 2026, pending regulatory approvals.
    • “This acquisition enhances the services we offer and expands Valley residents’ access to care,” HonorHealth CEO Todd LaPorte said in the announcement. The financial terms were not disclosed.” 
  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s prior authorization gold card program has seen a more than 40% increase in the number of qualifying provider groups in 2025, the company shared with Becker’s.
    • “Launched in October 2024, the program reduces prior authorization requirements in favor of advance notification for provider groups that consistently adhere to evidence-based care guidelines.
    • “Providers can lose gold-card status because of patient safety issues, failure to cooperate with quality and patient safety activities, failure to make timely responses to requests for information, or because they no longer meet program requirements. UnitedHealthcare conducts annual evaluations for gold card qualification, with determinations effective on Oct. 1 every year. 
    • “On Sept. 1, provider groups could begin viewing their program status in the UnitedHealthcare Provider Portal. Starting Oct. 1, additional groups will be eligible.”
  • and
    • “Economic uncertainty and policy changes from the current administration have changed the way health plans operate over the past year. Many have found workarounds to continue efficiency and growth.
    • “Becker’s connected with five leaders to learn their biggest accomplishments so far in 2025.”
    • Check it out.
  • Milliman has posted its “2025 Milliman Retiree Health Cost Index.”
  • McKinsey & Co. discusses “the quantum revolution in pharma: Faster, smarter, and more precise.”
    • “Quantum computing presents a multibillion-dollar opportunity to revolutionize drug discovery, development, and delivery by enabling accurate molecular simulations and optimizing complex processes.”
  • Radiology Business notes,
    • “Hospital- and private equity-affiliated radiology practices command significantly higher prices than their independent practice counterparts, according to new research published Tuesday. 
    • “Consolidation of imaging groups has accelerated in recent years, with limited evidence on how this change impacts economics within the specialty. Researchers with Brown University recently set out to understand how such M&A activity has changed prices for radiology services, sharing their findings in the Journal of the American College of Radiology (JACR). 
    • “They found a noteworthy gap, with negotiated professional prices for hospital-based radiology services about 43% higher than independents. That’s compared to about 16% higher for investor-backed radiologists versus others in private practice. 
    • “Our findings demonstrate significant differences in negotiated radiologic service prices by practice ownership, with hospital and PE-affiliated practices able to negotiate higher professional fees than independent practices,” corresponding author Yashaswini Singh, PhD, MPA, a healthcare economist and professor with the Providence, Rhode Island, institution, and colleagues concluded. “These results highlight the financial implications of ongoing consolidation in radiology and underscore the need for continued research into how these trends affect radiologists, insurers and patients.”

Tuesday Report

David Ermer–AHRQ, CDC, CMS, Electronic health records, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services today announced prescription drug reforms that will become effective Oct. 1 originating from the Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule. Health IT tools certified by the HHS Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology will allow drug prescribers to compare drug prices in real time and identify lower-cost alternatives available under a patient’s insurance coverage, particularly if they are covered under Medicare Part D. Providers will also be able to submit prior authorizations for medical services electronically to accelerate the process. The HTI-4 rule was released in July as part of the Centers for Medicare & Medicaid Services’ inpatient prospective payment system final rule for fiscal year 2026.”
  • Beckers Hospital Review informs us,
    • “HHS launched a [public] dashboard Aug. 27 to track organ transplants that skip patients next in line on transplant waiting lists. 
    • “The practice, called “allocation out of sequence,” is growing in frequency. In 2024, organ procurement organizations skipped waitlisted patients for 19% of transplants from deceased donors, six times more often than from a few years prior. The frequency increase is partly driven by clinicians prioritizing favoritism and ease over fairness, according to The New York Times. 
    • “The Organ Procurement and Transplantation Network’s policies and national law mandates organ allocation follow a “match run” to rank eligible recipients based on medical urgency, distance and other factors, according to HHS. 
  • Beckers Payer Issues points out,
    • “Medicare Shared Savings Program Accountable Care Organizations generated record savings and continued to improve quality performance in 2024, CMS said Aug. 28.
    • “In 2023, the program saw $2.1 billion in net savings.” * * *
    • “Nearly all ACOs met quality reporting requirements, with more shifting to digital measures that use electronic health information. ACOs also saw health outcomes improve around controlled blood pressure, poor A1c control and depression screenings.” 
  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM), in collaboration with the Assistant to the President for Domestic Policy, today sent a comprehensive Frequently Asked Questions (FAQ) document to agencies to help support the implementation of the Merit Hiring Plan, pursuant to President Trump’s Executive Order 14170. The FAQ provides detailed guidance to federal agencies on reforming the hiring process to prioritize merit and fairness.
    • A key highlight of the Merit Hiring Plan is the introduction of a two-page resume limit for federal job applications submitted through USAJOBS, taking effect September 27, 2025. This reform ensures hiring managers focus on the most relevant qualifications and experience, streamlining the review process. OPM is providing a transition period until the deadline, along with updated USAJOBS guidance and resume-building tools online to assist applicants in meeting the new standard.
  • The Government Accountability Office released a report titled “Illicit Fentanyl: DHS Has Various Efforts to Combat Trafficking but Could Better Assess Effectiveness.
    • “With about 48,000 deaths in 2024, fentanyl continues to be the primary cause of overdose deaths in the United States.
    • “The Department of Homeland Security has various efforts to combat the trafficking of illicit fentanyl. For example, it inspects incoming travelers and shipments and conducts patrols along the border.
    • “We reviewed these efforts and found issues with how DHS assesses their effectiveness. For example, DHS hasn’t set performance goals and measures—so it’s hard to know if DHS is making progress in its efforts to stop the flow of fentanyl.
    • ‘We recommended, among other things, that DHS set such performance goals and measures.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased. Approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age.
    • Nicotine pouches contain concentrated nicotine that can be harmful or potentially fatal to young children, even in small amounts. Toxic effects in young children have been reported with nicotine doses as low as 1 to 4 milligrams. Symptoms of nicotine poisoning may include confusion, vomiting, and loss of consciousness. 
    • “I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children. Manufacturers should consider what steps they can take to prevent accidental exposures and ingestion.” 
    • “The FDA is also issuing information for consumers on how to properly store nicotine pouches and prevent accidental exposure to children.” * * *
    • To date, the FDA has authorized 20 nicotine pouch products, all of which make use of child-resistant packaging, which are listed at www.fda.gov/authorizednicotinepouches.  

From the public health and medical/Rx research front,

  • The AP reports,
    • “A New York City hospital and another city-run building were sources for a deadly outbreak of Legionnaires’ disease in Harlem that killed seven people and sickened dozens of others, health officials announced Friday. 
    • “The New York City Health Department said bacteria from cooling towers atop Harlem Hospital and a nearby construction site where the city’s public health lab is located matched samples from some of the ill patients.
    • “The agency said they consider the bacterial cluster officially over since the last day anyone reported symptoms of Legionnaires’ disease was three weeks ago on Aug. 9. Since the outbreak, seven people have died and 114 people have been diagnosed with Legionnaires’ disease, while six people are in the hospital.” * * *
    • “City health officials said all facilities in the affected area have cleaned and disinfected their cooling towers. 
    • “They also are considering a series of changes to try to prevent future outbreaks. Among them are requiring building owners to test for Legionella every 30 days instead of the current 90-days and increasing the fines for violations for failure to comply with local cooling tower regulations.”
  • Beckers Hospital Review points out,
    • “Following almost a decade of decline, prostate cancer incidence in the U.S. increased 3.0% per year between 2014 through 2021, according to a report published Sept. 2 in CA: A Cancer Journal for Clinicians. Incidence of advanced-stage prostate cancer at diagnosis had the highest rate of increase at about 4.7% per year.
    • “At the same time, prostate cancer mortality continued to decline, though at a slower rate than the previous two decades. Prostate cancer mortality declined by 0.06% over the past decade, compared to the 3% to 4% annual decline seen in the late 20th and into the early 21st centuries.
    • “For the report, researchers analyzed cancer incidence and mortality data collected by the CDC and the National Cancer Institute through 2021 and 2023, respectively.” * * *
    • “Read the full report here.” 
  • NPR Shots relates
    • “People who inherit two copies of a gene variant called APOE4 have a 60% chance of developing Alzheimer’s by age 85.
    • “Only about 2% to 3% of people in the U.S. have this genetic profile, and most of them don’t know it because they’ve never sought genetic testing.
    • “But three scientists are among those who did get tested and learned that they are in the high-risk group. Now, each is making an effort to protect not only their own brain, but the brains of others with the genotype known as APOE4-4.”
  • Check out their stories.
  • Per Health Day,
    • “Common over-the counter painkillers might be quietly fueling antibiotic resistance, a new study warns.
    • “Ibuprofen and acetaminophen appear to enhance mutations in E. coli, making the common bacteria more resistant to the broad-spectrum antibiotic ciprofloxacin, researchers reported in the journal npj Antimicrobials and Resistance.
    • “What’s more, the two drugs amplify this effect when used together, researchers found.
    • “Antibiotic resistance isn’t just about antibiotics anymore,” said lead researcher Rietie Venter, an associate professor with the University of South Australia.
    • “This study is a clear reminder that we need to carefully consider the risks of using multiple medications – particularly in aged care where residents are often prescribed a mix of long-term treatments,” she said in a news release.”
  • BioPharma Dive relates,
    • “Ionis on Tuesday said its new lipid-lowering drug Tryngolza met the main goals of two Phase 3 clinical trials that could expand its use. Results showed the drug significantly reduced triglyceride levels in people with severely elevated levels of the fat in their bloods and prevented accompanying pancreatitis episodes.
    • “The company will ask the Food and Drug Administration by the end of the year to add severe hypertriglyceridemia to Tryngolza’s label. The drug, Ionis’ first wholly owned product, gained approval in December for a rare inherited condition called familial chylomicronemia syndrome, for which it recorded $25.6 million in sales over the first six months of 2025.”
  • Per a corporate news release,
    • “United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its TETON-2 study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis (IPF) met its primary efficacy endpoint of demonstrating improvement in absolute forced vital capacity (FVC) relative to placebo.
    • “Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL (Hodges-Lehmann estimate, p <0.0001) from baseline to week 52 in patients with IPF. Benefits of Tyvaso were observed across all subgroups, such as use of background therapy (nintedanib, pirfenidone, or no background therapy), smoking status, and supplemental oxygen use.
    • “Statistically significant improvements relative to placebo were also observed in most secondary endpoints, including time to first clinical worsening event, as well as changes from baseline to week 52 in percent predicted FVC, King’s Brief Interstitial Lung Disease quality of life questionnaire (K-BILD), and diffusion capacity of lungs for carbon monoxide (DLCO). While not statistically significant, both time to first acute exacerbation of IPF and overall survival at week 52 trended in favor of Tyvaso. Treatment with Tyvaso was well-tolerated, and the safety profile was consistent with previous Tyvaso studies and known prostacyclin-related adverse events. No new safety signal was seen.
    • “It is a profound honor to witness the power of scientific innovation realized for patients in need,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “TETON-2’ssuccessful outcomeaffirms the anti-fibrotic power of Tyvaso. We have unlocked new hope for patients with IPF and their families.”
  • The American Medical Association lets us know what doctors wish their patients knew about rebound congestion.
  • Per MedPage Today,
    • “Patients with type 2 diabetes who were treated with GLP-1 receptor agonists were less likely to develop peptic ulcer disease (PUD), a nationwide study found.
    • “In an analysis of more than 65,000 patients, GLP-1 users had 44% lower odds of PUD compared with non-users (adjusted OR 0.56, 95% CI 0.45-0.71, P<0.001), reported Trisha Pasricha, MD, MPH, of Beth Israel Deaconess Medical Center in Boston, and colleagues.
    • “In a subgroup of patients with a history of metformin use, switching to a GLP-1 receptor agonist for second-line treatment was associated with a 56% lower hazard of PUD compared with switching to insulin (adjusted HR 0.44, 95% CI 0.30-0.63, P<0.001). By 2 years, the cumulative PUD risk was 1.8% in the GLP-1 group versus 4.5% in the insulin group, the authors reported in Clinical Gastroenterology and Hepatology.”
  • and
    • “A personalized message about advanced colorectal neoplasia risk to patients and providers had no effect on colorectal cancer screening uptake, a randomized trial showed.
    • “Among 1,084 average-risk patients, the predicted probability of completing colorectal cancer screening with a personalized decision aid was 36.8% versus 41% with a generic decision aid (P=0.18), reported Peter H. Schwartz, MD, PhD, of the Indiana University School of Medicine in Indianapolis, and colleagues.
    • “For the 214 providers who were sent personalized notifications about patients’ risk, the predicted probability of the patient completing screening was 41.5% versus 36.4% for those who received a generic notification (P=0.135), they noted in the Annals of Internal Medicine.
    • “The overall result was negative, although there were some really interesting results in subgroups,” Schwartz told MedPage Today.”
  • and
    • “Among older adults, the incidence of myocarditis or pericarditis was lower among those who received the high-dose inactivated flu vaccine versus the standard-dose vaccine.
    • “There were only two cases of myocarditis observed among over 300,000 study participants, both in the standard-dose group.
    • “These results may not be generalizable to younger people, who are at greater risk of inflammatory cardiac conditions.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna’s health services division Evernorth has invested $3.5 billion in Shields Health Solutions as the company continues to build out its lucrative specialty pharmacy business.
    • “Shields, which helps hospitals and other providers create and manage their own specialty pharmacies, is one of five standalone businesses created from pharmacy behemoth Walgreens, which was acquired and chopped up by private equity firm Sycamore Partners last week.
    • “Evernorth’s investment in the form of preferred stock does not give Evernorth a controlling stake in Shields and is not expected to materially impact Cigna’s earnings guidance for 2025. The deal does give the company the option to invest more in Shields in the future.”
  • Fierce Healthcare announced its “FIERCE 50 OF 2025, the people and organizations advancing what’s possible in health, science and patient care.”
  • Beckers Hospital Review tells us,
    • “The University of Texas at San Antonio merged with The University of Texas Health Science Center at San Antonio on Sept. 1 to become The University of Texas at San Antonio. 
    • “The University of Texas System shared plans to merge the two entities into a unified institution in late August 2024. 
    • “The institution, which is now Texas’ third-largest public research university, comprises 15 colleges and schools across six campuses, around 40,000 students, 17,000 employees, more than 320 undergraduate and graduate degrees, $486 million in annual research expenditures and a $1.3 billion endowment, according to a Sept. 1 news release.”
  • Hook’em. 
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative effectiveness of apitegromab (Scholar Rock Holdings), as well as the disease-modifying therapies nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA). Apitegromab is an investigational new drug seeking FDA approval for improving motor function in patients with SMA.” * * *
    • ICER has calculated a health benefit price benchmark (HBPB) to be between $4,600 and $30,200 per year.\
    • ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including clinical experts, carers and patient advocates, and representatives from US payers — convened to discuss the pricing implications and recommendations to ensure fair access. Key recommendations stemming from the roundtable discussion include: 
      • The manufacturer should set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments. Given the small average improvement in motor function for patients treated with apitegromab and the uncertainty about serious adverse events, manufacturer pricing should reflect ICER’s value-based price range in moderating launch pricing.
      • The use of SMN-directed therapy after gene therapy or in combination should only be done in the context of research studies.
      • A randomized trial should be performed of first-line therapy in asymptomatic patients identified through newborn screening to better understand the comparative advantages and disadvantages of each of the three SMN-directed therapies.
    • ICER’s detailed set of policy recommendations is available in the Final Evidence Report and in the standalone Policy Recommendations document. 
  • Per Healthcare Dive,
    • “Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. 
    • “The study, published on Aug. 22, looked at 950 AI medical devices authorized by the Food and Drug Administration through November 2024. Sixty of the devices were associated with 182 recall events. 
    • ‘The most common causes of recalls were diagnostic or measurement errors, followed by functionality delay or loss. About 43% of all recalls also took place within one year of FDA authorization. 
    • “Tinglong Dai, lead author of the study and a professor at the Johns Hopkins Carey Business School, said the “vast majority” of recalled devices had not undergone clinical trials. For the majority of AI-enabled devices, which went through the FDA’s 510(k) pathway, clinical studies are not required. 
    • “Unfortunately, it’s not required, and so people don’t do it,” Dai said in an interview. “So, that’s why we believe it is one of the most important drivers of the recalls.”
    • “By comparison, the study found that devices that had gone through retrospective or prospective validation were subject to fewer recalls.” 
  • Per BioPharma Dive,
    • “Novartis is once again taking aim at Parkinson’s disease, through a deal with Arrowhead Pharmaceuticals that could be worth billions of dollars.
    • “The deal, announced Monday, revolves around a preclinical drug that Arrowhead designed to silence the genetic instructions for “alpha-synuclein,” a protein tied to Parkinson’s disease and other brain-eroding illnesses. Novartis has now agreed to pay $200 million for an exclusive license to research, develop, manufacture and commercialize the drug.
    • “Arrowhead could receive an extra $2 billion or more by hitting certain development goals and collecting royalties on any resulting products. Per deal terms, Novartis will also be able to select additional disease targets outside of Arrowhead’s current pipeline to advance using the latter’s drug making technology, which centers on a technique called RNA interference.
    • “The companies plan to close their agreement sometime this year.”
  • and
    • “The biotechnology careers of John Maraganore and Clive Meanwell have brought them into collaboration time and time again.
    • “As the respective founders of Alnylam Pharmaceuticals and The Medicines Company, the two previously partnered on the drug that would ultimately become Leqvio, which was later bought in a $10 billion acquisition of Medicines Co. by Novartis. And before Alnylam, Maraganore had led development at Biogen of Angiomax, which was later licensed to Meanwell’s company.
    • “Now, the two have partnered to launch and run Corsera Health, which aims to make a preventive medicine for cardiovascular disease as well as an artificial intelligence tool to identify who could benefit from earlier heart intervention. 
    • “Corsera’s target are younger people who are not “willing to wait 40 years to see whether they have a heart attack,” Meanwell said. “They’re saying, ‘What can I find that will help me?’”
    • “Corsera’s lead drug, an RNA interference therapeutic now in preclinical testing, is designed to be a once-yearly injection that blocks two targets known to drive cardiovascular disease: PCSK9 and angiotensinogen. The company expects to begin clinical testing by the end of the year.”

Welcome back, Congress

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC,

  • The AP summarizes the issues facing Congress this month.
    • “The most urgent task for Congress is to avoid a government shutdown on Sept. 30, when federal funding runs out. And it’s so far unclear if Republicans and Democrats will be able to agree on how to do that.
    • “Congress will have to pass a short-term spending measure to keep the government funded for a few weeks or months while they try to finish the full-year package. But Republicans will need Democratic votes to pass an extension, and Democrats will want significant concessions.
      Senate Democratic Leader Chuck Schumer’s vote with Republicans to avoid a shutdown in March prompted furious backlash within his party.”
  • Roll Call explains Congress’s expected activities this week.
  • Speaking of which, the House Appropriations Committee will mark up the Financial Services and General Government appropriations bill on Wednesday September 3 at 10:30 am ET. This is the bill that funds OPM and the FEHB Program, among other items.
  • Bloomberg Law adds,
    • “House Republicans are taking a middle-of-the road approach to funding the federal health department by making deeper cuts than their Senate counterparts but granting only some of President Donald Trump’s wishes.
    • House appropriators unveiled their version of the appropriations bill for the Health and Human Services Department on Monday, which provides the department $108 billion in discretionary funding, cutting $7 billion—or 6%—from the previous year.
    • Read the bill text here and summary here.
    • This is lower than the $116 billion proposed in the Senate, but still higher than the $94.7 billion in Trump’s budget request.
  • Federal News Network reports,
    • “Most civilian federal employees will see a 1% pay increase in 2026, according to a pay plan the White House quietly transmitted to Congress, with one big exception: Law enforcement officers will see bigger raises, though it’s not yet clear exactly which ones.
    • “For the majority of workers, the annual increase is the smallest it’s been since 2021, when President Trump also directed a 1% increase during his last year in office. Presidents are required to submit an “alternative pay plan” by Sept. 1 of each year in order to keep larger formulaic raises from taking effect the following year under the Federal Employee Pay Comparability Act (FEPCA).
    • “However, a yet-to-be-determined number of federal law enforcement officers will get a 3.8% raise next year, in line with the increase military members will receive in 2026.
    • “In the same message to Congress, the president said the law enforcement raise is meant “to increase recruitment and retention in critical law enforcement roles and to ensure our great Federal law enforcement officers are treated fairly.”
    • “But it will be up to federal agencies and the Office of Personnel Management to determine which employees will be eligible for the larger law enforcement raise. Starting on Tuesday, OPM will begin consulting with agencies to identify “categories” of law enforcement personnel who will receive it.”

From the public health and medical research front,

  • NBC News reports,
    • “Six deaths from rabies have been reported over the last 12 months in the U.S., the highest number in years, according to the Centers for Disease Control and Prevention. From rabid skunks in Kentucky to gray foxes in Arizona and raccoons on Long Island, wild animals in more than a dozen places across the U.S. have experienced a rise in the deadly disease, at least partly driven by shrinking natural habitats and better surveillance.
    • “We are currently tracking 15 different likely outbreaks,” said Dr. Ryan Wallace, who leads the rabies team at the Centers for Disease Control and Prevention. Areas with outbreaks include Nassau County, New York, which issued a health threat over rabid animals last month, as well as Cape Cod, Massachusetts, and parts of Alaska, Arizona, California, Indiana, Kentucky, Maine, North Carolina, Oregon and Vermont.
    • “There are parts of the United States where it does seem like we’re getting more calls and more reports,” Wallace said, noting an increase in rabid foxes in the West and rabid bats across the country. “Whether those numbers are truly significant increases, we can only tell at the end of the year. But right now, at peak rabies season, it does seem like activity is higher.”
  • The Wall Street Journal reports,
    • “Novo Nordisk said its blockbuster Wegovy weight-loss drug cuts the risk of heart attack, stroke or death by 57% compared with Eli Lilly’s Mounjaro and Zepbound.
    • “The Danish pharmaceutical giant said Sunday that the study suggests the heart-protective benefits of semaglutide—the active ingredient in Wegovy—may not be the same for all GLP-1 drugs such as tirzepatide, which is the active ingredient in Lilly’s Mounjaro and Zepbound.
    • “The real-world study used evidence gathered from actual patient experiences rather than a controlled trial, it said.
  • Per Medscape
    • “A noticeable deficit of highly unsaturated lipids — including omega-3 fatty acids — found in women with Alzheimer’s disease (AD) but not in cognitively healthy women is linked to worse cognition and biomarkers of neurodegeneration and inflammation, new research showed. 
    • “Investigators found no significant difference in lipid profiles in men with AD compared to healthy peers, and the effects of unsaturated phospholipids on AD were not mediated by cholesterol, low-density lipoprotein (LDL), or apolipoprotein B.
    • “The study reveals that Alzheimer’s lipid biology is different between the sexes, opening new avenues for research,” senior author Cristina Legido-Quigley, PhD, from King’s College London, UK, said in a statement. 
    • “Our study suggests that women should make sure they are getting omega fatty acids in their diet — through fatty fish or via supplements. However, we need clinical trials to determine if shifting the lipid composition can influence the biological trajectory of Alzheimer’s Disease,” Legido-Quigley said. 
    • “The study was published online August 20 in Alzheimer’s & Dementia.”
  • and
    • “Current US heart failure guidelines that use a single cut point for natriuretic peptides (NPs) can underestimate the risk for the disease for people with obesity, according to a study published recently in Circulation: Heart Failure.
    • “The 2022 joint guidelines from the American Heart Association, the American College of Cardiology, and the Heart Failure Society of America added NP as a biomarker for higher risk, with a threshold of 125 pg/mL to up-classify individuals from stage A (at-risk) to stage B (pre-heart failure).
    • “But concentrations of the proteins typically are lower in people with obesity, said Jennifer Ho, MD, a cardiologist at Harvard Medical School in Boston, so she wondered whether clinicians who follow the recommendations might be underestimating the risk for heart failure in their patients with obesity.”
  • Consumer Reports, writing in the Washington Post, tells us about “Labneh, a Middle Eastern dairy food, has a tangy flavor and health benefits similar to that of yogurt.”
  • “A Wall Street Journal article explains what it means to give up ultra processed foods and another informs us
    • “Fiber-Packed Foods Are Hitting Store Shelves. Be Careful, Doctors Say. Researchers link fiber used in processed foods with inflammation and other health problems.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • The healthcare industry continues to face rapid transformation, with financial, technological and operational pressures reshaping how organizations deliver care. CommerceHealthcare® has identified key mid-year developments that are influencing strategic decision-making across the sector. The year to date can be characterized by the following:
      • Financial update
      • Fresh uncertainties and persistent “structural” issues cloud the industry’s generally improving financial health.
      • There is ongoing commitment to automation and technology investment.
      • Patient affordability pressures fuel the need for financial assistance programs.
      • Migration from status quo operational models to substantially new ones is paramount.
    • A scan of leading metrics reveals both the progress and the prevailing challenges:
      • Cash. Days cash on hand varies widely across health systems.
      • Profitability: Through April, hospital margins are running near or above 3% versus the mid-1% range throughout 2024.[1] Smaller hospitals continue to struggle in 2025, as do physician groups. The median investment (loss) per physician full-time equivalent stands at an annualized $347,240, a 4.8% increase compared to 2024, and a 16.3% jump from 2023.”[2]
      • Revenue/volume: Larger hospitals experienced 24 consecutive months of year-over-year (YOY) growth through April in gross operating, inpatient and outpatient revenues.
  • HR Dive tells us,
    • “When faced with an overly complicated or long application, 57% of job candidates have abandoned it in the middle of the process due to frustration, according to an Aug. 14 report from LiveCareer.
    • “On top of that, 41% of job seekers said they think fewer than a quarter of their applications make it to a real person, which adds to their frustration during an increasingly tough labor market.
    • “The biggest job search frustrations stem from a lack of communication and confusing application processes, leading many candidates to give up on the job search,” Jasmine Escalera, a career expert for LiveCareer, wrote in the report.
    • “The majority of U.S. workers believe the application process should take less than 30 minutes, according to a survey by Employ, Inc. A third also said they’d quit an application if it took too long.”

Cybersecurity Dive

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

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

From the cybersecurity vulnerabilities and breaches front,

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

From the ransomware front,

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

From the cybersecurity defenses front,

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

Friday report

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

From Washington, DC,

  • Here’s a link to this week’s blog post from the OPM Director Scott Kupor. The week’s post concerns the federal government’s budget.
  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM) today announced that its guidance memorandums to federal agencies will now be housed directly on OPM.gov to make them easier to find and more accessible. The former page will be transitioned to a new page on OPM’s website and will also be available here.
  • The New York Times reports,
    • “CVS and Walgreens, the country’s two largest pharmacy chains, are for now clamping down on offering Covid vaccines in more than a dozen states, even to people who meet newly restricted criteria from the Food and Drug Administration.
    • “On Thursday, Amy Thibault, a spokeswoman for CVS, said the vaccine was not available at pharmacies in 16 states, citing “the current regulatory environment” and emphasizing that the list could change.
    • “On Friday, CVS issued an update: It could administer vaccines in 13 of the 16 states, and in the District of Columbia, to people who had obtained a prescription from a doctor or other medical provider. (As of Friday morning, its online scheduling tool still did not allow anybody to book an appointment in those places; Ms. Thibault said an update was in progress.) In Massachusetts, Nevada and New Mexico, CVS still cannot offer the shots at all, Ms. Thibault said.
    • “She did not provide an explanation for the change.
    • “Walgreens said in a statement that it was “prepared to offer the vaccine in states where we are able to do so” to people who met the F.D.A. criteria. When a New York Times reporter tried to schedule vaccine appointments in all 50 states, the Walgreens website said patients would need a prescription in 16 of them. Though there is some overlap, it’s not the same set of 16 as CVS, underscoring the level of confusion.” * * *
    • “CVS will make the vaccines readily available nationwide if the advisory panel recommends them, Ms. Thibault said. (In the 34 states where the company hasn’t set limits, people can simply check a box when they make an appointment online to attest that they meet the F.D.A. criteria, without a prescription or other documentation.) But since the panel hasn’t yet made a decision, the company is holding back in states where it believes its pharmacists need a C.D.C. endorsement.”
  • Fierce Healthcare informs us,
    • “While data released earlier this week raised questions about the administrative costs associated with No Surprises Act (NSA) arbitrations, a second study suggests the legislation is working to reduce out-of-pocket costs for members.
    • “Researchers at Harvard University and Mass General Brigham examined a sample of 17,351 privately insured adults, 8,204 of which lived in states that gained protections against surprise billing thanks to the legislation. The remaining 9,147 lived in states where some kind of program was already in place to protect consumers against these costs.
    • “The study found a significant decrease in out-of-pocket spending for people living in the new intervention states. The study attributes savings of $567 in yearly out-of-pocket costs to the protections.
    • “In fact, the study suggests that these protections are leading to greater savings for consumers than other policy changes such as Medicaid expansion and the drug pricing policies under the Inflation Reduction Act (IRA). Expanded Medicaid was tied to a $152 decrease in annual out-of-pocket spending, while the IRA is estimated to drive $400 in savings each year for people with Medicare Part D coverage.”
    • “Our study findings support anecdotal reports that the NSA has successfully shielded patients from surprise billing,” the researchers wrote.
  • FEHBlog note — The two studies do not contradict each other.
  • The American Academy of Actuaries released a report on Medicare’s financial condition.
    • “Consistent with prior trustees’ reports, the 2025 Medicare Trustees Report stresses the serious financial challenges facing the Medicare program. It remains critical to address the HI [Medicare Part A trust fund] shortfall sooner rather than later. In addition, Medicare spending will continue to grow faster than the economy, increasing the pressure on beneficiary household budgets as well as the federal budget, threatening the program’s sustainability.
    • Medicare’s financial challenges could be more severe than projected, which leaves policymakers with the challenge to address the short- and longer-term challenges of program solvency while understanding the potential implications on beneficiary’s ability to afford and receive appropriate health care. Understanding the implicit and explicit consequences of any potential change or lack thereof requires continued collaboration between actuaries, program and agency staff, consumer advocates, and Congress.

From the Food and Drug Administration (FDA) front,

  • Fierce Pharma reports,
    • “While Sanofi originally had its eye on tolebrutinib when it purchased its partner Principia Biopharma for $3.7 billion five years ago, another one of the BTK inhibitors inherited from the biotech has made it across the FDA finish line first.
    • “The drug rilzabrutinib, which is now approved as Wayrilz in immune thrombocytopenia (ITP), has been hailed (PDF) by Sanofi as a potential “multi-indication blockbuster” that could deliver 2 billion to 5 billion euros at its sales peak. 
    • “The FDA’s approval on Fridayspecifically clears Wayrilz for use in adults with persistent or chronic ITP who haven’t responded to prior therapy. 
    • “The regulatory endorsement marks the first approval for a Bruton tyrosine kinase (BTK) inhibitor to treat ITP in the U.S., where the condition is estimated to affect around 100,000 people, Mike Quigley, Ph.D., Sanofi’s CSO and global head of research, said in an interview with Fierce.”
  • and
    • “Aiming to deliver blockbuster sales of its Alzheimer’s disease-fighting antibody Leqembi in its 2027 fiscal year, Eisai has cleared a key regulatory hurdle in its quest to grow the medicine’s reach.
    • “The FDA has approved a once-weekly subcutaneous maintenance dose of the drug in an autoinjector, dubbed Leqembi IQLIK, according to a joint press release from the Japanese pharma and its commercialization partner Biogen.
    • “In line with the label of the drug’s intravenously infused formulation, Leqembi IQLIK is cleared for use in Alzheimer’s patients with mild cognitive impairment or mild dementia. Patients may switch to the new subcutaneous maintenance dose after 18 months of intravenous (IV) initiation treatment every two weeks, or they can opt to stick with infusions every four weeks for maintenance therapy, Eisai said in its release.
    • “IQLIK’s approval could be a “gamer changer” in Alzheimer’s treatment, Katsuya Haruna, senior group officer and EVP of US business operations at Eisai, said in an interview with Fierce Pharma, noting that the 15-second injection is now the first and only amyloid therapy that can be administered at home.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is going up across the country. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP adds,
    • “SARS-CoV-2 detections in wastewater are “very high” in Alabama, Hawaii, Louisiana, Nebraska, Nevada, South Carolina, Texas, Utah, and Washington, DC. They are high in 11 states. “Nationally, the wastewater viral activity level for COVID-19 is currently moderate,” the CDC said.
    • “In comparison, flu and respiratory syncytial virus (RSV) wastewater levels are listed as very low nationwide. ED visits for those two diseases are also listed as very low, but they are increasing for flu.”
  • Per Medscape,
    • “For older adults, the vaccine against respiratory syncytial virus (RSV) appears to be most effective in the first year after administration, according to new researchthat shows the benefits of the immunization fall roughly 60% within about 1.5 years.
    • “The database analysis showed that among adults aged 60 years or older, the effectiveness of the RSV vaccine at preventing infections fell from 71% at the 4-month mark to 40% 19 months after receipt.
    • “For clinicians, “the big takeaway is that the RSV vaccine works well, especially in the first year, and remains worth recommending to older patients, especially those at higher risk,” said Kersten Bartelt, RN, a research clinician at Epic Research, an arm of the records company, who helped conduct the analysis.”
  • The New York Times reports,
    • “A salmonella outbreak linked to eggs has sickened 95 people across 14 states, federal health officials said on Thursday. Eighteen people have been hospitalized.
    • “The company Country Eggs, of Lucerne Valley, Calif., has issued a recall of its large brown cage free “sunshine yolks” and “omega-3 golden yolks” eggs, according to the Food and Drug Administration.
    • “The recalled eggs were sold in grocery stores and delivered to food service distributors in California and Nevada between June 16 and July 9 and have sell-by dates between July 1 and Sept. 18. The recalled cartons were also sold under the brand names Nagatoshi Produce, Misuho and Nijiya Markets.
    • “Most of the people who have become ill so far — 73 of the 95 — are from California, according to the Centers for Disease Control and Prevention. But infections have been reported in 13 other states across the country, including in Washington State, Minnesota, New York and Pennsylvania. No one has died.”
  • Kaufmann Hall lets us know,
    • “A new report shows that the difference between expected and observed mortality rates for hospitalized surgical patients continues to improve. Hospitals have achieved nearly a 20% increase in survival rates for these patients compared with expected, reflecting advances in evidence-based care and safety practices. However, the analysis, from Vizient and the American Hospital Association, also finds that the average length of stay has risen by almost a full day over the past five years, due to increasing patient acuity and insurer-related delays in post-acute care placement, particularly in Medicare Advantage plans. This trend suggests ongoing challenges in balancing improved patient outcomes with efficient hospital throughput.”
  • Per Fierce Pharma,
    • “Flying high after an FDA approval four months ago to treat generalized myasthenia gravis (gMG), Johnson & Johnson’s much-touted Imaavy (nipocalimab) has taken a hit, coming up short as part of a combination therapy in a rheumatoid arthritis (RA) trial.
    • “Without revealing data from the phase 2a Daisy proof-of-concept study, J&J said that after 12 weeks, Imaavy provided no added benefit when added to an anti-TNFα therapy in patients with refractory RA.
    • “Based on these findings, Johnson & Johnson has decided not to proceed with the clinical development of nipocalimab in combination with an anti-TNFα therapy for RA,” the company said in its release.
    • “Despite the setback, J&J added that it is still “confident” that Imaavy can live up to the $5 billion-plus peak sales potential the company has pegged for the FcRn-blocking monoclonal antibody.”
  • Per Fierce Biotech,
    • “Zydus Therapeutics has racked up a phase 2b/3 win in primary biliary cholangitis (PBC), clearing the path to a filing to establish the company as a challenger to Gilead Sciences, Intercept Pharmaceuticals and Ipsen.
    • “The phase 3 part of the trial randomized 149 people to receive the PPAR agonist saroglitazar or placebo. After 52 weeks of daily oral dosing, 48.5% of patients on the Zydus drug met the biochemical response, achieving the primary endpoint of the trial. Zydus plans to discuss the data with the FDA with hopes of filing for approval in the first quarter of 2026.
    • “If approved, saroglitazar will enter a market served by other drugs, including rival PPAR agonists. The FDA approved two PPAR agonists in PBC last year, clearing Gilead’s Livdelzi and Ipsen’s Iqirvo to compete for the market with Intercept’s FXR agonist Ocaliva.
    • “Gilead reported (PDF) a 62% biochemical response rate in the study that supported approval of Livdelzi. Ipsen’s Iqirvo achieved (PDF) a 51% biochemical response rate in its pivotal trial.
    • “Unlike the PPAR agonists, Intercept’s Ocaliva carries a boxed warning. The FDA rejected a filing for full approval of the product in November—while leaving the accelerated nod in place—and flagged liver injury reports in December.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “The University of Pennsylvania Medical Center (UPMC) continues to flip last year’s losses, reporting this week a $348.6 million operating income (2.1% operating margin) for the six months ended June 30 thanks to increased volumes and a tighter underwriting margin.
    • “The integrated nonprofit had posted a $313.3 million operating loss (-2.2%) during the same period a year prior. Both half-year periods included tens of millions in restructuring costs—$30 million in 2025 and $87.8 million in 2024—under an effort the system had launched last year.
    • “For its second quarter alone, UPMC notched a $111.2 million operating gain compared to the prior year’s $210.3 million operating loss, both inclusive of restructuring costs. Total operating revenue during the first half of 2025 came to $16.5 billion.”
  • Beckers Payer Issues points out “Californians enrolled in Medicare Advantage are facing slower growth in healthcare costs compared to those in traditional Medicare, according to new research from the UCLA Center for Health Policy Research.”
  • Genetic Engineering and BioTechnology News offers its “updated A-List of the top 10 best-selling prescription drugs based on 2024 sales. Top-selling drugs 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.”
  • BioPharma Dive tells us,
    • “Novo Nordisk is again looking for help outside its own laboratories as it works to build on the success of Ozempic and its sister medicine Wegovy.
    • “In the latest deal, Novo will provide research funding for Replicate Bioscience as well as up to $550 million in payments to work on new treatments for obesity, Type 2 diabetes and other cardiometabolic disorders.
    • “The agreement includes an unspecified amount of cash upfront as well as money tied to certain milestones, Replicate said Thursday.”
  • Per Fierce Pharma,
    • “Pfizer is taking a curtain call for Vyndaqel, the low-dose version of its blockbuster tafamidis franchise for the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM).
    • “Pfizer will discontinue Vyndaqel in the U.S. by the end of 2025, multiple amyloidosis patient groups alerted their members on social media earlier this month.
    • “The move will leave the high-dose Vyndamax as the only tafamidis brand on the market.
    • “This decision was made to enhance patient-centered care and convenience as Vyndamax offers the same active ingredient and clinical benefits as Vyndaqel, but in a single capsule taken once daily, making it easier for patients to take their prescription,” according to the posts, which appear to be relaying a message from Pfizer.”