Monday report

Congress

Monday report

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

“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From Washington, DC,

  • The U.S. Census Bureau informs us,
    • “Veterans Day originated as “Armistice Day” on Nov. 11, 1919, the first anniversary of the end of World War I. Congress passed a resolution in 1926 making it an annual observance, and it became a national holiday in 1938. Sixteen years later, then-President Dwight D. Eisenhower signed legislation changing the name to Veterans Day to honor all those who served their country during war or peacetime. On this day, the nation honors military veterans — living and dead — with parades and other observances across the country and a ceremony at the Tomb of the Unknown Soldier at Arlington National Cemetery in Virginia.
    • “The following facts are made possible by the invaluable responses to U.S. Census Bureau surveys. We appreciate the public’s cooperation as we continuously measure America’s people, places and economy. 
    • “Veteran Population
      • “15.7 million
        • “The number of military veterans in the United States in 2025, representing 5.9% of the total civilian population age 18 and over.
      • “0.3%
        • “The share of veterans in 2025 who served during World War II. Additionally, 2.3% of veterans served during the Korean War, 30.9% during the Vietnam War, 25.6% during the Persian Gulf War, and 31.4% during the Post-9/11 period (September 2001 to present).
      • “30.5%
        • “The share of veterans age 75 and older in 2025. At the other end of the spectrum, 8.4% of veterans were under age 35.”
  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Nov. 9 announced allocations for the second year of the Rural Health Transformation Program, which will award $10 billion annually to all states from fiscal year 2026 through FY 2030. The program helps rural hospitals fund projects to expand access to care, bolster the rural workforce, modernize facilities and technology, and support innovative payment and care delivery models. Fifty percent of the funding is distributed equally among all states, while the additional 50% is allocated based on rural health needs and proposed impact.” 
  • Here is a CMS link to its fact sheet on this announcement.
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced an expansion of the TOPx HHS Tech Sprint for AI and Invisible Illness prize pool from $2 million to $3.8 million, responding to strong public interest and the quality of submissions. Today’s announcement recognizes 40 Phase 2 winners receiving $3.7 Million from the expanded prize pool for working prototypes that use AI and federal open data to address complex chronic conditions.” * * *
    • Explore TOPx submissions and participate in People’s Choice voting at InvisibleIllness.Crowdicity.com. Learn more about HHS Lyme disease initiatives at HHS.gov/Lyme.
  • Beckers Hospital Review relates,
    • “CMS is seeking public comment on what should count as “reasonable and relevant” terms in contracts between Medicare Part D plan sponsors and network pharmacies, with comments due Nov. 23, according to a Sept. 24 request for information in the Federal Register. The SBA’s Office of Advocacy flagged the deadline to small businesses Nov. 9.
    • “Part D plans must already contract with any pharmacy that accepts their standard terms and conditions, and those terms must be “reasonable and relevant,” but CMS has never defined the phrase. The request is a first step toward implementing a provision of the Consolidated Appropriations Act of 2026 that makes the standards apply to plan years starting on or after Jan. 1, 2029.”

From the U.S. Office of Personnel Management front,

  • Fedweek reports,
    • “OPM has issued a memo seeking comment on how it plans to implement raises for federal law enforcement personnel in 2027 – while pay for most civilian personnel remains frozen.
    • “Covered law enforcement personnel will get a 3.8 percent raise, but newly covered groups could see a 2.77 percent catch up for last year on top of that, totaling around 6.7 percent. Those proposed groups include:
      • “GS employees in approved law enforcement officer (LEO) positions under 5 U.S.C. 5541(3), except those who qualify based on frequent direct contact with detained suspects or convicts
      • “GS-0083 Police, except VA police on title 38 special rates, whose adjustment will be handled separately
      • “GS-0080 Security Administration employees who regularly perform both physical security and law enforcement duties and have arrest authority
      • “GS-1811 Criminal Investigators
      • “Certain OIG positions. * * *
    • “OPM may separately set 3.8 percent special rates for CBP agricultural inspectors and certain firefighters, and it will contact agencies for staffing data, according to the memo. Coverage applies automatically unless agencies opt out by Nov 25. Special rates remain capped at $197,200, and the new special rates are expected by the end of the year.”
  • FedSmith discusses,
    • “The $7,500 Dependent Care FSA in 2027: Who Saves, and Who Should Take the Tax Credit Instead
      • “The Dependent Care FSA limit is now $7,500, but a rewritten tax credit means some federal families may come out ahead by skipping it this Open Season.”

From the U.S. Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “The FDA is requiring safety labeling changes for GLP-1 receptor agonists over a potential increased risk of a rare eye condition that can cause vision loss.
    • “The agency is requiring drugs including Eli Lilly’s Mounjaro and Zepbound and Novo Nordisk’s Ozempic and Wegovy to add information about non-arteritic anterior ischemic optic neuropathy, or NAION, to the warnings and precautions section of their labeling, according to a Nov. 9 drug safety communication. NAION can cause sudden, painless vision loss in one eye, which can be permanent. The FDA said it evaluated clinical trial, animal and postmarket data, including observational studies and case reports, in reaching its decision.”
  • The Wall Street Journal adds,
    • “Dozens of patients have sued Novo Nordisk and Eli Lilly, the biggest makers of these drugs, arguing the medications caused them to lose vision. The companies are fighting the lawsuits and have said previously that studies don’t prove any GLP-1s cause NAION. 
    • “A spokeswoman for Eli Lilly said the company is evaluating the FDA update and will respond to the agency soon. A Novo spokeswoman said the company continues to monitor the safety of its medicines and work with regulators, and that it remains confident the benefits outweigh the risks of its GLP-1s.” 
  • Fierce Healthcare relates,
    • “The FDA has launched a safety investigation into Novartis’ gene therapy Zolgensma following reports of tumors in patients, as concerns flare up over genomic insertion risks.
    • “Friday, the FDA confirmed it is evaluating cases of tumor formation in children previously treated with Zolgensma for spinal muscular atrophy (SMA). The agency’s diligence extends to Itvisma, a sister intrathecal formulation of the intravenously infused Zolgensma, as the two products contain the same vector and construct, even though Itvisma itself has no reported cases of tumor to date, the FDA said.
    • “At the center of the investigation is a biological process known as insertional oncogenesis, where the viral vector used to deliver functional copies of the therapeutic material inserts itself into human genes.” 
  • BioPharma Dive lets us know,
    • “The Food and Drug Administration on Monday approved a new kind of blood thinner meant to lower the risk of stroke in certain adults, marking a major milestone for cardiovascular research as well as the medicine’s developer, Bayer.
    • “The pill, which will be sold under the brand name Sunharbo, doesn’t work like established stroke prevention drugs. It inhibits a blood-clotting protein called Factor XIa. While this protein plays a minor role in sealing up blood vessels after an injury, it also amplifies a coagulation “cascade” that helps clots grow and makes them harder to break down, increasing the risk of strokes or heart attacks.”
  • MedTech Dive tells us,
    • “Novocure has been denied Food and Drug Administration approval for its device intended to treat non-small cell lung cancer that has spread to the brain.
    • “The FDA’s not approvable letter cited uncertainty around the degree of clinical benefit provided by Novocure’s device, Optune Mya, the company said Monday. The system uses low-energy electrical fields to disrupt cancer cells’ ability to grow and divide.
    • “The regulator did not raise concerns about the device’s safety profile, Novocure said. The company intends to meet with the FDA to determine if there are other options that would support approval without additional clinical studies.”
  • Fierce Pharma notes,
    • “Eli Lilly could soon see two label expansions for Foundayo, its oral GLP-1, in swift succession: In September, the drugmaker filed for U.S. review in Type 2 diabetes. And now, with new phase 3 data in hand, Lilly plans to approach the FDA about an application for obstructive sleep apnea (OSA).
    • “Backing the potential OSA label expansion is Lilly’s two-study, phase 3 Attain-OSA trial, presented Monday at the American Heart Association (AHA) Scientific Sessions 2026 and published in JAMA. At 52 weeks, the collective 712-patient program met its primary endpoint, with Foundayo (orforglipron) significantly reducing sleep apnea severity as measured using the standard apnea-hypopnea index (AHI) disease rating scale.” 
  • and
    • “Veradermics’ hair loss data package looks to be FDA-ready.
    • “Topline results are in for part B of the New Haven biotech’s phase 2/3 clinical trial in men with mild-to-moderate pattern hair loss, and the drug candidate, VDPHL01, did not disappoint. VDPHL01 achieved continued hair growth through one year and reported its highest hair count in the phase 3 program so far.
    • “VDPHL01 is an oral extended-release formulation of minoxidil—best known for being the active ingredient in Rogaine. Minoxidil was originally approved in the 1970s as a treatment for high blood pressure. Today, the generic is commonly prescribed off label as a hair-loss treatment, but the instant-release formulation can come with unwanted cardiac side effects and less-than-optimum impacts on hair growth. Veradermics attests that its extended-release design provides a steady absorption for better hair growth while avoiding the high concentrations that impact blood pressure.” 
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration is seeking feedback on a discussion paper released Nov. 6 on the benefits and risks of robotic medical devices with autonomous or remote teleoperation capabilities. The paper discusses devices intended for surgical procedures and those with nonsurgical applications such as positioning or controlling instruments or imaging tools to perform specific tasks. Comments on the paper are due by Jan. 5, 2027. The discussion paper follows guidance the agency released in September that includes recommendations on nonclinical testing, clinical data and labeling for premarket submissions of certain robotically-assisted surgical devices. The FDA seeks comments on the draft guidance by Nov. 24.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Elevance Health is the latest insurer to sue the feds over its performance in the latest round of star ratings for the Medicare Advantage program.
    • “The company sued the Centers for Medicare & Medicaid Services in District of Columbia federal court on Friday, arguing that the 2027 star ratings calculations violated the Administrative Procedure Act in using 11 measures that it says were adopted unlawfully.
    • “In the lawsuit, the company said that the harm from including these measures is “concrete and substantial.” If they were excluded, it would increase the scores for 12 of its Medicare Advantage contracts and generate $516 million in additional quality bonus payments.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership points out “seven infection threats hospitals are tracking this winter.”
  • The New York Times adds,
    • “On the last Friday in August, Gay Rabb Small went for her daily walk along the Tampa shore. Nearing 80, she was determined to stay healthy and walked at least five miles a day.
    • “That night at dinner, her daughter, Anna Small, noticed that her mother seemed a little off. “I thought she had overdone it,” Ms. Small said.
    • “By Saturday, Gay Small had developed a tremor, and her daughter took her to the emergency room, where she was diagnosed with dengue, a viral illness transmitted by mosquitoes. She died the following Friday, Sept. 4, her 80th birthday.
    • “Gay Small got dengue from a mosquito bite, probably from one of her daily walks. She is so far the only fatality among hundreds of people in Florida who have been sickened in a dengue outbreak that scientists and public health officials are struggling to understand. The size of the outbreak, they say, indicates that dengue may be making a comeback in the continental United States at a level not seen for many decades.” * * *
    • Dr. Gabriela Paz-Bailey [from the CDC] said she did not expect to see “explosive” outbreaks like in Puerto Rico because of the higher standard of living in the continental United States. “But I do think that we will continue to see locally acquired dengue — that this will become the norm,” she said.
  • STAT News relates,
    • “High blood pressure has earned its reputation as the silent killer. If someone has diabetes or has had a stroke, the risk of serious cardiovascular events posed by hypertension climbs even higher.  
    • “Three studies presented Saturday at the American Heart Association’s scientific sessions reported on recent attempts to lower blood pressure in people with these challenging medical histories, and how medical care should reach across specialties to treat them. One small but diverse trial tested a common diuretic after a stroke, another looked at intensifying treatment to reach lower-than-standard post-stroke blood pressure goals, and the third looked at going lower in people living with type 2 diabetes. 
    • “Each of the scientists leading the studies and the experts commenting on them at a media briefing emphasized the role of blood pressure. Adding a widely available drug earlier held promise for controlling blood pressure, but it was a split decision between the effects of lower numbers post-stroke and with diabetes.”
  • Health Day adds,
    •  Valvular heart disease (VHD) death rates increased from 2018 to 2023 and are predicted to remain higher than prepandemic levels through 2040, according to a study presented at the American Heart Association Scientific Sessions 2026, held from Nov. 6 to 9 in Chicago.
    • Hritvik Jain, M.D., from Allegheny General Hospital in Pittsburgh, and colleagues examined trends in VHD among older adults. The analysis included age-adjusted mortality rates (AAMR) using data from the U.S. Centers for Disease Control and Prevention WONDER database (1999 to 2023) for adults aged 65 years and older.
  • and
    •  Patients with early-onset Alzheimer disease (EOAD) have more extensive deposits of tau compared with those with late-onset Alzheimer disease (LOAD), according to a study published online Nov. 4 in Science Translational Medicine.
    • Konstantinos Chiotis, M.D., Ph.D., from the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues compared baseline and longitudinal tau positron emission tomography (PET) burden measured with 18F-flortaucipir and its relationship with clinical variables in amyloid PET-positive, cognitively impaired participants from the Longitudinal Early-Onset Alzheimer’s Disease Study (390 participants with EOAD) and Alzheimer’s Disease Neuroimaging Initiative (211 participants with LOAD).
  • Cardiovascular Business offers more insights from the American Health Association’s recent scientific sessions.
  • The American Medical Association lets us know what doctors want patients to know about urinary incontinence
    • “Urinary incontinence becomes more common with age, but patients do not have to live with it. Kegel exercises are one option that may help.”
  • BioPharm Dive informs us,
    • “An experimental two-drug combination from Vir Biotechnology has succeeded in the first of three Phase 3 trials against chronic hepatitis D, the company said Sunday. 
    • “Vir’s drugs, “elebsiran” and “tobevibart,” met their main objective in the study by largely eliminating detectable signs of the virus and normalizing levels of an important liver enzyme in 44% of treatment participants after 48 weeks. By comparison, none in a “delayed treatment” cohort achieved those results, according to Vir. 
    • “The regimen also met a key secondary endpoint focused solely on dropping viral levels, with 79% of treated patients achieving a treatment response. 
    • “Two additional Phase 3 trials are ongoing and should produce data early next year. Results from all three studies, if positive, would support a regulatory submission in 2027.” 

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

  • Healthcare Dive reports,
    • “More than 500 U.S. hospitals are owned by private equity firms, representing 11.9% of all private hospitals, according to new data from the watchdog group Private Equity Stakeholder Project.
    • “PE firms also own around a third of all for-profit hospitals in the U.S., according to the data.
    • “A small group of investors own the bulk of PE-owned facilities, the PESP data added. Apollo Global Management, which owns Lifepoint Health and ScionHealth, owns 200 facilities in the U.S. Meanwhile, the firm Welsh, Carson, Anderson & Stowe owns 124 facilities.”
  • Beckers Clinical Leadership points out,
    • “Hospitals with better nurse staffing levels had lower average emergency department boarding times than hospitals with high patient-to-nurse ratios, a recent study found.
    • “The study, published in the November issue of the Journal of Emergency Nursing, analyzed nurse staffing data and ED boarding times from 335 hospitals in Florida, New Jersey and Pennsylvania. 
    • “In hospitals with patient-to-nurse ratios of four or fewer, the average ED boarding time was about 20 minutes shorter than in hospitals where nurses cared for five or more patients. The study authors said improving nurse staffing levels is “often overlooked as a strategy” to cut boarding times and improve patient throughput.” 
  • Beckers Hospital Review relates,
    • “Palo Alto, Calif.-based Stanford Medicine and Sacramento, Calif.-based Sutter Health held a ribbon-cutting ceremony ahead of the planned Dec. 1 opening of the Stanford Medicine Sutter Health Cancer Center in Oakland, Calif.
    • “The outpatient cancer center is located on Sutter Health’s Alta Bates Summit Medical Center campus, according to a Nov. 9 news release from Stanford Medicine.
    • “The center will offer outpatient clinics, infusion, imaging, radiation oncology, ambulatory surgery, breast health and pharmacy services, along with clinical research, genetic counseling, nurse navigation and survivorship programs.”
  •  and
    • “Morgantown, W.Va.-based WVU Health acquired Wheeling, W.Va.-based Orchard Park Hospital Nov. 1, according to a news release.
    • “The hospital now operates as a remote campus of WVU Medicine Wheeling Hospital and has been renamed WVU Medicine Healthy Minds – Kids. The facility held a ribbon-cutting Nov. 9 and will continue Orchard Park’s specialized behavioral and mental health care for children.
    • “The acquisition continues WVU Health’s system expansion. In October, the system acquired Greensburg, Pa.-based Independence Health System’s five hospitals and their affiliated physician practices and outpatient facilities.”
  • BioPharma Dive tells us,
    • “Argenx, a Netherlands-based biotechnology company focused on antibody drugs, on Monday said it has agreed to acquire a protein specialist in a potentially billion-dollar-plus deal.
    • “Unnatural Products has a platform that pairs machine learning, screening and other techniques to engineer “macrocyclic peptides.” These peptides are larger and more complex than typical small molecules, which allows them to more effectively bind to tricky proteins and address some challenging diseases. Yet, they’re still tiny enough that they can be swallowed. Argenx plans to use the platform to develop oral, durable medicines for serious immune-mediated diseases.
    • “The acquisition carries a $550 million upfront cash payment. Unnatural Products could receive up to $595 million more if specific milestones are hit. The companies expect their deal to close before the end of the year.”
  • Fierce Healthcare informs us,
    • “HealthTap is rolling out a new program for Medicare Advantage plans that seeks to help members form a connection with a primary care doctor that carries forward.
    • “The program leans on a combination of proactive outreach and access to a patient’s historical medical records to support plans in identifying needs or risks, filling care gaps and coordinating follow-up or other necessary care. It’s built to directly support individuals who may not have a PCP on file.
    • “HealthTap reaches out to those members proactively, the company said, and helps them schedule an initial virtual visit with a provider who stays connected for preventive services, chronic condition management and medication concerns.”
  • Per Healthcare Dive,
    • “Hospitals collectively lost an estimated $132 billion last year due to write-offs for bad debt and final claim denials, according to a new report from revenue cycle analytics company Kodiak Solutions.
    • “Revenue leakage was up by nearly 18% compared to 2024, as hospitals continued to see write-offs take up about 10 percent of net revenue last year, the analysis of Kodiak’s proprietary data showed.
    • “This increase comes in the face of rising revenue cycle technology budgets, with more AI tools coming to market promising to improve hospitals’ financial performance, Kodiak executives said.”

Weekend Update

David Ermer–Agentic & Generative AI, CMS, Congress, Federal employment benefits, Medicare, OPM, U.S. Healthcare–

“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From Washington, DC

  • Roll Call discusses what is likely to happen on Capitol Hill this week.
  • The Federal Benefits Open Season begins at noon (ET) tomorrow. OPM adds,
    • “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 14, 2026 for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) and Postal Service Health Benefits Program (PSHB) ends at 11:59 pm, per the location of your electronic enrollment system, on Monday December 14, 2026.”
  • Beckers ASC Review reports,
    • “Physician leaders warn that CMS’ 2027 Medicare physician fee schedule final rule will put more strain on independent practices and make it harder for patients to get care.
    • “The final rule, released Nov. 4, cuts the conversion factor 2.31% to $32.63 for physicians who aren’t qualifying participants in an advanced alternative payment model. CMS had proposed a 1.68% cut in July. Much of the drop comes from the expiration of a temporary 2.5% payment increase for 2026. The rule also finalizes a 20% payment reduction for certain evaluation and management services billed with modifier 25 on the same day as a zero-day global procedure.”
  • Contemporary OB/GYN tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) has included the American Medical Association’s (AMA) new obstetric billing codes in the final 2027 Medicare Physician Fee Schedule, according to a statement from Camille A. Clare, MD, MPH, CPE, FACOG, president, American College of Obstetricians and Gynecologists.1 
    • “ACOG is deeply grateful to CMS for including AMA’s new obstetric codes in the final 2027 Medicare Physician Fee Schedule, and we look forward to ushering in a new system that will contribute to improved maternal health outcomes,” Clare said in part. “This change follows years of ACOG advocacy and will address several challenges related to the current method of billing for prenatal care services.” 
  • The FEHBlog guessed last Sunday that CMS would announce the Medicare Part B and D premiums after the national election day on November 3. We are now three business days past election pay with no announcement. Perhaps the announcement will be made this week.

From the public health and medical / Rx research front,

  • The New York Times reports,
    • Nutrient deficiencies are rare in the United States, thanks in part to advances in food fortification in the 1900s. But many people, especially those in certain high-risk groups, are still not meeting daily recommendations for some nutrients, said Teresa Fung, a nutrition professor at Simmons University in Boston.
    • Nutrient inadequacies typically don’t cause the obvious symptoms that severe nutrient deficiencies do, Dr. Fung said. But they sometimes cause more vague symptoms that can affect quality of life and increase the risk of certain health conditions.
    • [The article identifies] “five, commonly under-consumed nutrients in the United States, according to experts — and the signs you may be falling short.”
  • and
    • “Cardiologists have been on edge for months, waiting for the details surrounding recent reports of the stunning failures of two new heart drugs.
    • The drugs — pelacarsen and ziltivekimab — were widely expected to usher in a new era in preventing heart disease. Companies, betting on the drugs’ promise, made huge investments in developing them.
    • So when doctors saw preliminary announcements that the drugs were not helping patients in large clinical trials, many felt blindsided, although still hopeful that there was more to the story than they knew.
    • “The whole cardiovascular community was gobsmacked,” said Dr. Karol Watson, a director of UCLA’s preventive cardiology program.”
    • Were the drugs close to succeeding, just barely missing a statistically significant benefit? Or were there at least subgroups of patients who were helped?
    • “Now the answers are in. There was not a shred of evidence that the drugs helped anyone. By every measure, they were no better than placebos.
    • “The results, Dr. Watson noted, “are about as neutral as they can be.” The full data were presented on Saturday morning at the annual meeting of the American Heart Association and in simultaneous publications in The New England Journal of Medicine.”
  • The Washington Post relates,
    • “The humble flu shot may have a hidden talent: fighting cancer.
    • “In a small clinical trial in Ohio, doctors injected an ordinary flu vaccine straight into patients’ skin tumors, hoping to fool the immune system into mistaking the cancer for an infection.
    • The ruse seemed to take. Immune cells flooded into most of the injected tumors. By the time surgeons cut the cancers out, more than a third of patients showed signs that their tumors were in retreat. In a few, no trace of cancer remained.
    • “The trial involved just 18 patients and lacked a comparison group, so the findings are far from proof that the approach works. But they hint at a possibly inexpensive, off-the-shelf way to help cancer patients and offer an alternative to cancer vaccines, a field that has lately centered on bespoke, highly expensive shots built to match the mutations in each patient’s tumor. The findings were presented last week at the Society for Immunotherapy of Cancer’s annual meeting in Phoenix.”
  • Cardiovascular Business tells us,
    • “The Society for Cardiovascular Angiography and Interventions (SCAI) released updated cardiogenic shock classifications to help clinicians better identify patients at risk, assess disease severity, and determine whether treatments are restoring adequate organ perfusion.
    • “The 2026 SCAI SHOCK Classification Expert Consensus Update, published in the Journal of the SCAI (JSCAI) in conjunction with the 2026 American Heart Association (AHA) Scientific Sessions, represents the third iteration of the classification system first introduced in 2019.[1] The framework has become widely adopted in clinical care, research and regulatory settings as a common language for communicating cardiogenic shock severity.
    • “Srihari Naidu, MD, FACC, FAHA, MSCAI, immediate-past SCAI president and director of the catheterization laboratories at Westchester Medical Center, was a co-chair of the consensus writing group. He said the update retains the familiar five-stage classification, A through E, while refining how clinicians identify patients at risk of deterioration and evaluate their response to treatment. Originally issued in 2019 and revised in 2022, this new iteration incorporates additional data from the past few years.
    • “We were happy that most of the data that had supported the shock classification and showed that really it was instrumental in improving shock care and really tracking with mortality. This is the third iteration of the shock classification, and I think people will agree that this has been a major step forward,” he said.
    • “One of the most important clarifications is the emphasis on tissue hypoperfusion rather than blood pressure alone when determining shock severity.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Right now, there is no pharmaceutical treatment for obstructive sleep apnea, a condition that is estimated to affect more than one billion people globally and approximately 30 million Americans. Multiple studies (notably in 20101 and 20172) report that as many of half those prescribed continuous positive airway pressure (CPAP)—the gold standard apnea therapy—reject it outright, and between 12% and 25% of those who begin those treatments abandon CPAP within three years.
    • “The reason for such high non-compliance is that CPAP is uncomfortable and socially awkward, Joel Latham, president and CEO, Incannex Healthcare, says. His company aims to be the first to potentially market an oral pharmaceutical therapy for obstructive sleep apnea.
    • “Latham says Incannex Healthcare’s mission is “targeting indications that have limited or no treatment options available.” So, while a therapy for obstructive sleep apnea, known as IHL-42X, is its lead therapeutic, the company’s pipeline also includes therapeutics based on distinctly different therapeutic platform to treat generalized anxiety disorder and rheumatoid arthritis.”

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

  • Beckers Hospital Review reports,
    • “Hospital sales are picking up steam as various health systems under financial pressure look to trim underperforming assets, exit noncore markets and redirect capital toward strategic priorities. 
    • “Recent hospital divestitures have come from nonprofit giants carrying hundreds of millions of dollars in operating losses, for-profit operators completing full-state exits and other systems shedding community hospital portfolios they no longer consider core to their portfolios. 
    • [The article identifies] “10 large health systems that have sold or announced plans to sell hospitals this year.”
  • Healthcare Dive adds,
    • “It was a busy Thursday morning at the strip mall in White Hall, West Virginia. Once the sprawling grounds of Middletown Mall, the state’s first shopping mall before it shuttered in 2017, customers shuffled under a searing August sun between stores like Michaels, Five Below, Ace Hardware and Tractor Supply.
    • “You’d be forgiven for overlooking the catty-cornered building sandwiched between the Department of Motor Vehicles and across the two-lane road from the Italian pizzeria. 
    • “The bright red “Emergency” sign over the front entrance might get your attention though. Or the Marion County ambulances with their engines idling around back.
    • The building, containing just two hallways, is Mon Marion Neighborhood Hospital, part of a burgeoning trend of small acute care hospitals dubbed “micro-hospitals” or “neighborhood hospitals” that can hold anywhere from eight to 25 inpatient beds.
    • The micro-hospitals are popping up nationwide — from Pennsylvania to Arizona, Colorado to Texas — as lower-cost alternatives to traditional hospitals, including in semi-urban and rural areas where care access is strained.
    • “It’s been well received by the community,” said David Goldberg, the former CEO of Mon Health System, owner of Mon Marion. “Very busy, very widely accepted.”
    • “Micro-hospitals differ from freestanding emergency rooms or urgent care, two types of care sites that are offered as solutions to the rural care crisis because they have inpatient care capabilities. Though diminutive, the facilities are certified as hospitals according to federal standards set by the CMS.”
  • Fierce Healthcare relates,
    • “Omada Health saw its “strongest quarter ever” in the third quarter of 2026, CEO and co-founder Sean Duffy told investors and analysts during a Thursday evening earnings call.
    • “We delivered our highest quarterly revenue, gross margin progression, and our most profitable quarter to date,” Duffy said.
    • “The virtual chronic care provider, which went public last June, brought in $91 million in revenue—up 34% year-over-year—and reported gross margin of 76% on a GAAP basis and 78% on a non-GAAP basis, according to Duffy. Omada reported net income of $7 million in the third quarter, compared with a net loss of $3 million in Q3 2025.
    • “The company also reported adjusted EBITDA of $12 million, compared to $2 million the year prior. 
    • “It beat Wall Street analysts’ estimates for revenue, though slightly trailed behind projections for total membership.
    • “Total members reached 1.1 million, up 36% year-over-year, with trailing 12-month revenue per total member increasing 5% year-over-year to $294, according to financial results publishedThursday. Average member tenure also grew 10% compared to the year prior, to approximately two years and four months. Member retention has improved to 58%, up from 43% in Q4 of 2024, executives said.”
  • Beckers Payer Issues tells us,
    • “Aetna left the ACA market at the beginning of 2026, citing underperformance. Other insurers have also been navigating a rocky ACA landscape, marked by the expiration of enhanced premium subsidies and shifting risk-pool dynamics.
    • “CVS Health previously recorded a $448 million premium deficiency reserve in the first quarter of 2025 for its individual exchange business related to expected losses that year. During that quarter’s earnings call, former CFO Tom Cowhey had projected losses for the individual exchange business between $350 million and $400 million for full-year 2025.
    • “Aetna CFO Andreana Santangelo recently joined the Becker’s 5th Annual Fall Payer Issues Roundtable and shared more about the decision. 
    • “Very early on, you could see that we just didn’t have the right cost structure for our ACA business,” she said. 
    • “Citing her experience at a Blues plan and at Cigna, Ms. Santangelo said considerations around scale and cost structure are especially important for that business line. 
    • “While addressing how scale can be about more than sheer numbers, Ms. Santangelo said that “scale is also about having the right kind of risk pool” and attracting the right people who will find value in the product.”
  • Fierce Healthcare informs us,
    • “Equiti is acquiring Lexi AI to build a hybrid language-access model that combines AI language support with human medical interpreters. 
    • “Equiti, which sells medical interpretation services to hospitals and health systems through its Martti business, provides 24/7 access to qualified medical interpreters across more than 250 languages and dialects. Lexi provides multilingual, AI-powered medical interpretation. The acquisition deal merges Lexi’s immediate AI language support, covering over 35 languages and dialects, with Martti and its network of qualified medical interpreters to help healthcare organizations expand language access.
    • “The acquisition was announced October 28. Financial details of the deal were not disclosed.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Congress, Cybersecurity, HIPAA Privacy and Security Rules–

From the frontier AI front,

  • Cyberscoop reports,
    • “OpenAI announced a new cybersecurity-focused model Thursday [November 4], citing internal benchmark testing that shows improvements in vulnerability discovery, patch development and adherence to safety guardrails meant to block out-of-scope work.
    • GPT-6 Cyber will first be available to a limited number of customers in OpenAI’s Daybreak Red program, which uses more advanced or nonpublic cybersecurity models for offensive red teaming.
    • “As a preview of the model’s capabilities, OpenAI officials said GPT-6 has found at least 81 “novel” vulnerabilities in the Firefox web browser, developed exploits for 948 Linux kernel vulnerabilities and was able to develop and validate a critical remote code execution vulnerability in Brotli, a popular open-source data compression tool. All the vulnerabilities were reported to owners and patched. 
    • “OpenAI officials told reporters Wednesday that the new safeguards include additional identity and account security requirements, more frequent check-ins from the model to OpenAI when a request is made to perform high-risk behaviors, and additional monitoring for “misalignment” or rule-breaking.”
  • The Wall Street Journal asks
    • “What if the mathematical locks and keys that secure our bank accounts, email inboxes and everything else on the internet turn out to be a lot less secure than we thought? What if the password-protected internet we rely on every day collapses?
    • “Quantum computers have long threatened such an apocalypse. For decades, engineers have been preparing for their arrival—and their inevitable abuse by well-heeled bad guys.
    • The result is known as “postquantum cryptography.” According to leading mathematics experts, an orderly transition of the world’s digital systems to this new paradigm should avert an event that could otherwise send us back a century, technology-wise.
    • “But now there is a potentially more pressing issue: AI’s impressive math skills.
    • Artificial intelligence is pushing advances in various mathematics fields at an unprecedented rate, conquering problems that our puny human minds have wrestled with for centuries. The fear is that this could include new solutions to the math problems that keep our encrypted communications encrypted.”
  • Cybersecurity Hub, writing in LinkedIn, adds,
    • “The US National Institute of Standards and Technology (NIST) has published its final roadmap for transitioning to post-quantum cryptography, marking a significant step towards replacing the cryptographic technologies that underpin digital communications, authentication and data protection.
    • “NIST IR 8547, Transition to Post-Quantum Cryptography Standards, identifies the existing standards vulnerable to future quantum computers and the quantum-resistant alternatives organisations will need to adopt. The publication moves the discussion beyond algorithm selection towards the practical challenge of coordinating migration across products, services and interconnected systems.
    • “For security leaders, the significance extends beyond choosing new encryption software. The transition will require visibility into cryptographic dependencies, cooperation with suppliers and decisions about which information and systems need protection first.”
  • CISA announced,
    • “CISA, the Australian Signals Directorate’s Australian Cyber Security Centre (ASD’s ACSC) and the National Security Agency (NSA) released joint guidance and an accompanying quick-reference list to help organizations assess vendor readiness for transitioning to post-quantum cryptography (PQC). As quantum computing advances, widely used public-key cryptography will become vulnerable to compromise from cryptographically relevant quantum computers (CRQCs). To protect their systems and data, organizations must plan for and transition to PQC—which includes algorithms capable of withstanding both classical computing and quantum-enabled threats—before CRQCs become available. 
    • “Many organizations rely on third-party vendors for managed services, cloud capabilities, and other cryptography-dependent products and services. Cryptography is also embedded in systems and devices that are difficult to update, tied to long asset lifecycles, and require vendor support or replacement—such as industrial control systems and Internet of Things (IoT) devices. Reliance on vendors means that effective PQC transition depends on vendor readiness, and early, structured engagement with these vendors is critical to planning efforts. 
    • Organizations can use the vendor-neutral questions outlined in this guidance to determine whether a vendor understands quantum-related risks, maintains transparency over its cryptographic implementations, and supports a secure, cost-effective and timely transition to PQC. 
    • “Visit CISA’s PQC Initiative page for additional resources.”
  • McKinsey and Co. advises
    • “As AI makes it easier and faster for cyberattackers to discover and exploit vulnerabilities in software, companies must change their approach to safeguarding their digital assets and infrastructure.”

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive reports,
    • “Democrats’ big wins in the midterm elections are poised to transform cybersecurity policymaking and oversight on Capitol Hill, with potentially big implications for critical infrastructure operators and other businesses that work with the government.
    • “After Democrats take control of the Senate and the House of Representatives in January, they likely will ramp up scrutiny of the Cybersecurity and Infrastructure Security Agency (CISA), accelerate efforts to solve AI security challenges and revive cybersecurity grants for struggling local utilities, experts told Cybersecurity Dive. Republican lawmakers have largely ignored those subjects, in part to avoid angering or embarrassing President Donald Trump’s administration, but Democrats — newly energized by unexpectedly sweeping gains on Tuesday — are expected to take a far more assertive approach to cybersecurity hearings, investigations and legislation.
    • “Key figures in Congress’s new Democratic majority told Cybersecurity Dive that they viewed digital security as a top priority.”
  • and
    • “Three dozen business groups, including organizations representing critical infrastructure sectors, are pressing Congress to renew a major cybersecurity information sharing law before its expiration next month.
    • “The 2015 Cybersecurity Information Sharing Act “has become a foundational component of the nation’s cybersecurity,” the groups wrote on Sunday to the chairs and ranking members of the congressional armed-services committees.”
  • Cyberscoop adds,
    • “Republicans have talked about wanting to get the fiscal 2027 National Defense Authorization Act done in the lame duck. Besides the possibilities of CISA 2015 being included in the bill, Nicholas Leiserson, senior vice president for policy at the Institute for Security and Technology, said the Senate version of the legislation has a pair of very noteworthy cyber provisions: a “very broad” authorization for contractor-owned, contractor-operated offensive cyber operations, and a requirement that every artificial intelligence product sold to the Defense Department have an AI bill of materials.”
  • CISA announced,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) kicks off Critical Infrastructure and Resilience Month today [November 2], recognizing the systems and assets that keep the country running as well as the people who operate them. This year’s Critical Infrastructure Security and Resilience Month aligns with President Trump’s National Resilience Strategy and comes as we continue to see new and evolving threats, including those driven by rapid advances in technology like super intelligence. Through it all, we rely on frontline operators who keep essential services moving even when things are disrupted.
    • “Our work depends on people who understand their systems and stay prepared,” said Acting CISA Director Nick Andersen. “Resilience comes from knowing what matters most and having a plan you can actually use when something goes wrong.”
  • Federal News Network notes,
    • “The Cybersecurity and Infrastructure Security Agency is turning to a former Department of Health and Human Services official to head up CISA’s infrastructure security division.
    • “Brian Mazanec is now serving as acting executive assistant director for infrastructure security at CISA. He was sworn in Monday, according to CISA.
    • “Mazanec previously served as deputy assistant secretary and director of the Center for Preparedness within HHS’s Administration for Strategic Preparedness and Response (ASPR). He stepped down from ASPR last week after serving there since January 2023.
    • “During his time at HHS, Mazanec helped spearhead the department’s response to significant events like the Change Healthcare ransomware attack.“
  • Cyberscoop tells us,
    • “Delaware-based defense and aerospace company has settled a case with U.S. agencies over government allegations that the firm neglected its cybersecurity obligations in its contracts.
    • ILC — the name the government uses to collectively refer to ILC Dover and ILC Astrospace — agreed to pay $13 million to resolve the False Claims Act allegations involving its contracts with the Department of the Army, Missile Defense Agency and National Aeronautics and Space Administration.
    • “ILC, according to the government, submitted false or fraudulent claims for payment on contracts with the agencies because it knew it hadn’t complied with the contracts’ cybersecurity requirements over a period between 2018 and 2024.
    • “For instance, ILC allegedly used a third-party company to store sensitive data in the cloud without proper safeguards, and didn’t develop and update mandated security plans for each of its covered information systems.
    • “The best response to cyberattacks is to prevent them from happening in the first place,” Benjamin Wallace, U.S. Attorney for the District of Delaware, said in a news release Tuesday. “The obligations that ILC violated exist to prevent bad actors from taking advantage of the United States’ technical innovation.” 

From the cybersecurity breaches and vulnerabilities front,

  • On November 3, 2026, Binance shared on LinkedIn “29 October Binance Security Incident: Initial Findings and Response Update.”
    • “This is our initial report. It covers what we know today and what we have already improved. “The investigation remains ongoing and our findings will be subject to further independent review. Some technical details will remain confidential to prevent malicious actors from using them to plan attacks. We are engaging independent security firms for further review.
    • “The latest information released by the Federal Bureau of Investigation indicates that the Democratic People’s Republic of Korea is responsible for this incident.
    • “We are sharing this initial report because security improves when the industry learns together.”
  • HIPAA Journal tells us,
    • “Data breaches have been announced by HCA Healthcare, Blossom Health, El Camino Health, and University of Mississippi Medical Center.”
  • and
    • “Cleveland-based University Hospitals is working on restoring systems after an October 22 cyberattack. Cybersecurity incidents have also been announced by EyeMed Vision Care and Facial Surgery Group.”
  • Cybersecurity Dive reports,
    • “Authorities are investigating a cyberattack targeting a refrigeration-equipment supplier for the French Blood Establishment (EFS), which oversees France’s civilian blood supply.
    • “An unknown hacker was able to manipulate temperature controls at cold storage rooms for three EFS sites, according to the agency. Temperatures and defrosting thresholds were raised to very high levels. 
    • “EFS monitoring systems and alarms detected the activity, and staff were able to regain control. The supplies were transferred to other facilities, the agency said, and the integrity of those blood supplies was not compromised.” 
  • The American Hospital Association News adds,
    • “Federal agencies Nov. 5 issued a bulletin saying that they are aware of malicious cyber activity targeting industrial refrigeration and cold chain monitoring systems globally, including systems used within the healthcare sector. The agencies warned that threat actors may exploit unpatched or internet-accessible refrigeration controllers to remotely alter temperature settings, trigger extended defrost or heating cycles, cause inventory loss, create equipment hazards and disrupt temperature monitoring capabilities. The agencies are urging organizations to identify internet-exposed systems, remove unnecessary remote access, apply available patches and firmware updates, implement strong authentication controls, segment operational technology networks and review alerting and monitoring capabilities.”
  • Cybersecurity Dive relates,
    • “Hackers are using Artex and other agentic AI-based frameworks to scan public GitHub repositories for exposed credentials and API keys, according to a report Thursday from Microsoft Threat Intelligence.
    • “The credentials are then deployed in downstream attacks against targeted organizations. Starting Oct. 28, researchers found a single IP address using compromised but still-valid application credentials to sign into downstream tenants. 
    • “In one case, hackers were able to steal credentials and exfiltrate data from Azure Key Vaults and Storage Accounts, as well as abuse Azure AI services. Researchers also saw hackers using embedded shell commands in a user agent to exploit vulnerabilities as well as attempts to steal App Service authentication tokens.
    • “Microsoft researchers said the threat activity overlaps with a campaign using the same IP address, as outlined in research released Wednesday by Todyl. That report showed how hackers with stolen secrets for Entra ID signed into Microsoft 365 and Azure environments at various managed service providers.” 
       
  • Bleeping Computer informs us,
    • “Blockchain intelligence firm Chainalysis says a recent attack on its systems and internal tools has exposed credentials and live tokens for all customers.
    • “Chainalysis provides blockchain analysis tools to trace cryptocurrency transactions and investigate crimes such as fraud, ransomware, and money laundering. Its customer list includes law enforcement, government agencies, financial institutions, insurance companies, and cryptocurrency businesses worldwide.
    • “This follows the company’s disclosure last Friday that attackers using AI tools accessed customers’ names, email addresses, user IDs, and organizational role labels using what it described as “offensive agentic techniques.”
  • Computer Weekly lets us know,
    • “Two-thirds of the vulnerabilities Palo Alto Networks has uncovered using frontier artificial intelligence (AI) models had never been disclosed as Common Vulnerabilities and Exposures (CVEs), according to the security supplier’s CIO, Meerah Rajavel.
    • “Speaking to Computer Weekly on the sidelines of Singapore International Cyber Week last month, Rajavel said the sheer number of undisclosed vulnerabilities means organisations can no longer simply prioritise which known flaws to patch first.
    • “Palo Alto Networks has had an early look at what frontier AI can do. It was among the launch partners of Anthropic’s Project Glasswing, which gave a select group of organisations access to the unreleased Claude Mythos Preview model to find and fix flaws in critical software.
    • “The model’s knack for finding vulnerabilities made headlines, but that was not what surprised the company. “The thing that shocked us was how good it was in devising attack paths,” said Rajavel, referring to the model’s ability to chain vulnerabilities in novel ways.” * * *
    • Organisations cannot patch some systems at all, she said, especially those that run business-critical processes or rely on older technology that cannot take rolling updates.
    • “That makes virtual patching critical, said Rajavel, as it blocks exploit attempts at the network level until a fix is applied. She added that a good zero-trust architecture and attack surface management can help eliminate attack paths to a large part of an organisation’s infrastructure.”

From the ransomware front,

  • Spectrum News reports,
    • “A ransomware attack has disrupted services across the Queens Public Library system.
    • “The library system first reported a systemwide network outage on Wednesday, saying it was affecting its website and app, as well as checkout and return machines, renewals, on-site computers and free Wi-Fi access at all 66 branches.  
    • “As of Thursday morning, those services were still unavailable, Queens Public Library president and CEO Dennis Walcott said in a statement.
    • “All library locations are currently open as scheduled, but some virtual and in-person programs may be impacted, Queens Public Library said on social media.”
  • The Recorded Future News relates,
    • “Michigan State University officials said recent claims by a ransomware gang were tied to an incident last month that forced password resets for all student and employee accounts.  
    • “On Sunday evening [November 1], the BYOD ransomware gang added the university to its leak site — claiming to have stolen personal information on 1.3 million current and former students. Last week, BYOD caused outrage after attacking The University of New Mexico and shutting down its hospital.  
    • A spokesperson for Michigan State told Recorded Future News that the university “became aware of suspicious cyber activity and immediately began investigating the matter,” in early October.  
  • Tech Radar points out,
    • “Synology, a major network-attached storage (NAS) manufacturer, is warning users about ongoing ransomware attacks targeting devices running outdated software. It urged all users to apply provided patches and secure their devices without delay.
    • “In a brief announcement, Synology said it “identified threat actors exploiting a vulnerability patched in December 2024 to target devices running outdated versions of DSM.” The goal of the attacks seem to be data encryption and a ransom demand.
    • “Synology strongly urges all users running vulnerable versions to update DSM immediately to protect their systems. Synology also recommends enabling automatic updates to keep DSM up to date at all times.” * * *
    • “The company also did not say who the threat actors are, but according to BleepingComputer, there has been a “massive wave of reports” from Synology customers whose data was apparently locked down by the “C3rb3r” encryptor. These customers were asked to pay “thousands of dollars” in ransom, in exchange for the decryption key. The publication says the first reports started surfacing more than two weeks ago.”
  • Huntress offers guidance on how to protect against ransomware before it encrypts data,
    • “Phishing is one of the most common ways in, but not the only way. Exposed remote access, unpatched internet-facing systems, and stolen credentials work just as well for attackers.
    • “Backups are crucial to your security plan. Keep at least one copy offline or isolated, and test restores before you need them.”
    • “Ransomware usually leaves footprints. Catch the behavior early, and you can stop the attack before the ransom note shows up.”

From the cybersecurity business and defenses front,

  • The New York Times reports,
    • “Anthropic Is Racing to Obtain the A.I. Boom’s Most Vital Resource
      • “The company went on a deal spree with tech giants, former crypto miners and others to gain computing power to further its artificial intelligence ambitions.”
  • Cybersecurity Dive relates,
    • “Companies are struggling to oversee their AI agents because they don’t know what those agents’ normal behavior looks like, according to a new report.
    • “Nearly half (46%) of security professionals say they’re unable to establish safe baselines for agentic AI activity, the security firm Abnormal AI said in a report published on Thursday [November 4].
    • “The report highlights security gaps in AI oversight that businesses should prioritize as they increase their AI deployments.”
  • Security explains “Frontier AI Is Changing Cyber Defense: 15 Moves CISOs Should Make Now.”
  • Dark Reading offers,
    • “9 Cyber Awareness Tips That Actually Match Today’s Maze of Threats
      • “Practical guidance on safer search, stronger login security, better executive protection, and other habits can reduce enterprise risk.
  • Security points out,
    • “Companies are getting faster at disclosing cyberattacks and slower at explaining what those attacks actually cost. Since the SEC’s cyber disclosure rule took effect, a public company has four business days to file an 8-K once it determines an incident is material, often before it knows the full scope. The filing says some version of the same thing: Systems are affected, operations are disrupted, and whether the impact will be material has not yet been determined.
    • “Increasingly, these incidents get discussed as one problem, with cybersecurity, business continuity, and enterprise resilience collapsed together, when each does something different. Cyberattacks are hitting more often and doing more damage when they land, which makes the distinction matter more. Cybersecurity focuses on detecting and stopping the attack itself. “Business continuity and enterprise resilience determine how the organization keeps operating once that happens. Detection and containment alone aren’t enough. When disruption hits, the business continuity function must be able to answer what is impacted, what happens next, what is the financial exposure, and what should be prioritized.”
  • NIST announced
    • “A new NIST guide can help solo business owners — also called “solopreneurs” — grasp the basics of cybersecurity and craft a strategy that can help reduce their cybersecurity risk.
    • “The guide is designed to help solopreneurs prioritize and implement a selection of actions from the NIST Cybersecurity Framework that would best help their businesses.
    • “The publication is written in lay language and assumes no prior cybersecurity knowledge.”
  • FEHBlog note — This guide also may improve guidance for work at home staff.
  • Here’s a link to Dark Reading’s CISO Corner

Friday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, Telehealth, U.S. Healthcare–

“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From Washington, DC,

  • Govexec reports,
    • “Rep. James Walkinshaw, D-Va., fresh off his reelection this week, said Thursday that he will press for a 2027 pay raise for federal workers to be part of any deal to keep the government open past December 11.
    • “The congressman, whose district is home to roughly 50,000 federal employees, told Editor-in-Chief Frank Konkel at GovExec’s After the Midterms event that the government must increase compensation in order to compete for talent, particularly after the last two years of buyouts, layoffs and mass firings. In August, President Trump formally proposed freezing most civilian federal workers’ pay next year.” * * *
    • “Walkinshaw told reporters his starting point in spending negotiations will be the 4.1% average pay increase as proposed earlier this year in his Federal Adjustment of Income Rates Act.
    • “Walkinshaw said he was also optimistic that lawmakers would pass legislation restoring the collective bargaining rights of more than 1 million federal employees, though likely not in full until after the new Congress is seated in January. The House this year has passed standalone legislation that would unwind President Trump’s executive orders, which banned unions at most federal agencies on national security grounds, and it has included language in its draft of the annual National Defense Authorization Act that would roll the edicts back for Defense Department workers.”
  • Healthcare Finance News adds,
    • “Base physician pay will decrease in 2027 under the Centers for Medicare & Medicaid Services Physician Fee Schedule Final Rule released on Wednesday.
    • “For 2026, the Working Families Tax Cut legislation provided a one-year PFS conversion factor increase of 2.5% that will no longer be in effect for 2027, CMS said. 
    • “This means that current law requires a 2.5% reduction in Medicare payment.
    • “The American Medical Association on Thursday said the lame duck session, along with the continuing-resolution bill that has funded the federal government and is set to expire on Dec. 11, creates an opportunity. 
    • “This creates an opportunity for Republicans and Democrats to unite on an end-of-year legislative package that makes real progress toward fixing the unsustainable Medicare physician payment system,” the AMA said. 
    • “Among other priorities, the AMA wants Congress to extend the 2.5% physician payment update through 2027.”
  • The Wall Street Journal relates.
    • “President Trump said on Friday that longtime adviser Stephen Miller would become his chief of staff, replacing Susie Wiles after Republicans suffered far-reaching losses in this week’s midterm election. 
    • “In a Truth Social post, Trump called Miller one of his most trusted advisers and said he would be starting in the new role on Monday. Wiles, who has served as chief of staff since the beginning of his second term, will move to the president’s political operation, Trump said.
    • “I want to thank her for her service as Chief of Staff—She has done a great job!” Trump wrote of Wiles. Wiles was the first female White House chief of staff.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced a Notice of Funding Opportunity (NOFO) for the Women’s Initiative for Screening and Health (WISH) program. The program will award up to $1 million in fiscal year 2027 to establish a multidisciplinary coalition to update the HRSA-supported Women’s Preventive Services Guidelines (Guidelines) to reflect gold-standard evidence and support their use in clinical practice.
    • “The funding opportunity advances priorities outlined in President Trump and First Lady Melania Trump’s Executive Order 14437, Advancing Women’s Health to Improve Outcomes in All Phases of Life, including translating scientific research into improved clinical care and strengthening prevention for women and girls throughout every stage of life.” * * *
    • “Applications are due January 8, 2027, at 11:59 p.m. ET through Grants.gov under opportunity number HRSA-27-072. Applicants must have active SAM.gov and Grants.gov registrations.
    • “For details and application instructions, visit the WISH funding opportunity page.”
  • Today “the Internal Revenue Service announced the tax year 2027 annual inflation adjustments for almost 70 tax provisions, including the tax rate schedules, standard deduction amounts and other tax changes. Revenue Procedure 2026-35 PDF provides details about these annual adjustments.”

From the U.S. Food and Drug Administration front,

  • Radiology Business reports,
    • “The U.S. Food and Drug Administration has cleared a new artificial intelligence-powered intravascular ultrasound imaging system, the product’s developer announced on Wednesday.
    • “San Jose, California-based Evident Vascular says the regulatory win applies to its Guidance System and Evident peripheral imaging catheters. They’re intended for examination of pathology during certain peripheral vascular procedures handled by radiologists and other docs. 
    • “Evident says the system is designed to improve the clinician experience by combining high-fidelity imaging, “purpose-built AI,” and simple workflows without disruptions. Features include flush-less plug-and-play catheters, an “intuitive” user interface, and hands-free voice controls.
    • “FDA clearance marks an important milestone for Evident and the physicians who believed in this platform from our company’s inception,” Howard Rosen, CEO and co-founder of Evident Vascular, said in a statement Nov. 4. “We engineered the entire imaging architecture to deliver the image fidelity physicians need in a system that is both intuitive and easy to use.”
  • STAT News relates,
    • “The U.S. Food and Drug Administration conducted more unannounced drug inspections in India and China in Fiscal Year 2026 compared to the previous year, Regulatory Focus tells us. The increase is attributed to an effort by the agency to increase unannounced foreign inspections to achieve inspection parity between domestic and international facilities. The proportion of unannounced inspections in India increased from 47% in FY 2025 to 87% in FY 2026. In China, the percentage of unannounced inspections rose from 19% in FY 2025 to 61% in FY 2026.”
  • BioPharma Dive tells us,
    • “Eli Lilly will offer its obesity drugs Zepbound and Foundayo on Hims & Hers’ telehealth platform, the companies announced Friday. Under the deal, eligible patients with a prescription can use Hims to gain access to Lilly’s drugs at the same “self-pay” prices available elsewhere. Foundayo carries an initial $149 monthly price tag, while Zepbound starts at $299 per month.
    • “Hims had previously used legal loopholes to make lower-cost, compounded versions of GLP-1 weight loss drugs. But it changed course in March after a legal challenge from Novo, adopting a new strategy based on providing U.S. consumers access to an array of FDA-approved weight loss medicines. Hims struck a similar deal with Novo in March.”
  • Fierce Pharma adds,
    • “Eli Lilly has successfully challenged Good Life Meds’ claims about the health benefits and personalization of a compounded tirzepatide product.  
    • “Lilly, which sells the GLP-1/GIP drug tirzepatide as Mounjaro and Zepbound, challenged the telehealth provider’s claims through BBB National Programs’ National Advertising Division (NAD). The drugmaker, the only provider of FDA-approved tirzepatide products, disputed Good Life’s claims about the effect of the compounded drug on body weight, blood sugar, energy and lean muscle. 
    • “After assessing Good Life’s response to the challenge, the NAD recommended that the company stop making the express health benefit and personalization claims challenged by Lilly and modify its ads to remove unsupported implied claims about safety, efficacy and personalization.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity.
    • “The amount of acute respiratory illness causing people to seek health care is low.
    • “RSV activity is low in most areas of the country.
    • “COVID-19 activity is declining nationally.
    • “Seasonal flu activity continues to increase in many parts of the country.
    • “Rhinovirus/Enterovirus (RV/EV) is elevated nationally, and respiratory adenovirus (HAdV) is elevated in some regions of the country.”
  • The American Hospital Association News lets us know
    • “Nationally, there are now 5,182 confirmed measles cases this year, according to a Nov. 6 update from the Centers for Disease Control and Prevention. The vaccination status of 96% cases is unvaccinated or unknown.”  
  • The New York Times tells us,
    • “A resident of Washington State died this week after a severe case of bird flu, a new and worrying sign that the virus continues to be a threat in the United States.
    • “The news followed reports that the bird flu virus had been detected in dairy cattle on dozens of farms across the country over the past month. It has also been spreading unchecked for months at a mink farm in Utah.
    • “The death, in Yakima County, Wash., is the first related to bird flu in the country this year, and the third since 2024. But it was only on Thursday, one day after an inquiry from The New York Times, that the Centers for Disease Control and Prevention updated its website. It still has not made any statements to the public about the death.” * * *
    • “Bird flu is not yet a threat to most humans, but it does pose a significant risk to the millions of agricultural workers and veterinarians in the country, said Kristen Coleman, an expert an airborne infections at the University of Maryland.”
  • Genetic Engineering and Biotechnology News adds,
    • “Researchers at the University of Cambridge and Cambridge’s spin-out DIOSynVax, along with collaborators, reported on the development of a broad-spectrum bird flu vaccine that in animal trials provided complete protection against globally circulating, diverse H5Nx variants of the disease. Current pandemic preparedness relies on stockpiling vaccines against individual virus variants that have already emerged. The Cambridge team’s approach uses AI-guided engineering to create broadly protective vaccines intended to remain effective across a wide range of existing and future variants.
    • “The team’s study, described in Cell Reports Medicine, found the new digitally engineered multi-antigen mRNA vaccine to be superior to bird flu vaccines currently stockpiled by many governments for use in the event of a human outbreak. Their preclinical trial results showed that the existing vaccines tested protected only around 50% of animals exposed to multiple H5N1 bird flu variants, compared with complete protection achieved by the team’s new vaccine, DVX-panH5Nx.
    • “The results demonstrate the potential of AI-guided vaccine design in developing broad protective population immunity ahead of evolving biological threats. The researchers say the vaccine represents the third success with their AI-guided technique for designing vaccines against highly infectious viruses that threaten animal and human health. The new study in addition demonstrates that the team’s ‘plug and play’ approach can be used to create safe, highly effective vaccines for a plethora of infectious diseases threatening animal and human health globally.”
  • Health Day informs us,
    • “A common test used to diagnose obstructive sleep apnea may miss the condition in Black patients, potentially impacting important treatment decisions.
    • “Sleep studies often use pulse oximeters — small devices that measure blood oxygen levels — to help determine the severity of sleep apnea.
    • “In the new study, oxygen-based scoring counted roughly 20 percent fewer breathing events in Black participants than in white participants.
    • “But heart-rate-based scoring showed no comparable racial difference.
    • “The first author says the findings have “potential implications for diagnosis and severity classification.”
  • and
    • “A new study suggests a woman’s reproductive history may play an important role in her brain health later in life.
    • “Women are affected by Alzheimer’s disease more often than men. This may be related, in part, to fluctuations in estrogen levels throughout life,” said study author Anna Marseglia, an assistant professor at the Karolinska Institutet in Stockholm.
    • “Estrogen is known to have protective effects on both neuronal cells and blood vessels in the brain,” she added in a news release. “However, its potential role in women’s cerebrovascular health in later life has been largely understudied.”
  • MedPage Today points out,
    • “A retrospective-cohort analysis showed that GLP-1 receptor agonists were associated with a lower risk of obesity-related cancers as compared with insulin or sulfonylurea.
    • “Cancer risk with GLP-1 agonists did not differ significantly from metformin, DPP4 inhibitors, or SGLT2 inhibitors.
    • “The effect of GLP-1 agonists on cancer risk versus other diabetes medications was most noticeable in patients with low-severity diabetes.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Humana raised its full-year earnings outlook as consolidated income and revenue rose in the third quarter.
    • “The health insurer now expects 2026 adjusted earnings of at least $9.50 a share, up from its previous forecast of at least $9 a share.
    • “Humana’s third-quarter revenue jumped 26% to $41.16 billion, beating Wall Street estimates of $40.87 billion.”
  • and
    • “Moderna raised its full-year revenue growth outlook to 15% to 25% after swinging to a profit and logging higher revenue in the recent quarter.
    • “The higher outlook follows the U.S. approval of mFLUSIVA, Moderna’s mRNA-based influenza vaccine.
    • “Moderna swung to a third-quarter profit of $162 million, beating analyst expectations for a loss.”
  • Beckers Hospital Review relates,
    • “Atlanta-based Piedmont Healthcare reported a 10.7% operating margin for fiscal year 2026, generating more than $1 billion in operating income for the second consecutive year as revenue climbed to nearly $9.5 billion.
    • “The health system recorded $1.02 billion in operating income for the fiscal year ended June 30, up slightly from $1 billion in fiscal 2025, according to its financial documents published Nov. 6. However, its operating margin narrowed from 11.4% to 10.7% as expenses increased faster than revenue.
    • “Piedmont also strengthened its liquidity position, ending the fiscal year with $3.8 billion in cash and cash equivalents, while continuing to invest in hospital expansion projects across Georgia.
  • and
    • “Grand Forks, N.D.-based Altru Health System’s operating margin fell to -3% through the first nine months of 2026, as expenses outpaced revenue growth and the system moved closer to acquiring three more North Dakota hospitals from Chicago-based CommonSpirit Health.
    • “Altru Health reported an $18.2 million operating loss for the nine months ended Sept. 30, compared with a $1.7 million operating loss and -0.3% margin during the same period in 2025, according to its financial statements published Nov. 2.
    • “Revenue increased 8.3% year over year to $610.4 million, up from $563.6 million, while operating expenses climbed 11.2% to $628.6 million, compared with $565.3 million in the prior-year period.”
  • The Wall Street Journal tells us,
    • “The practice of keeping admitted patients in the emergency room while they wait for a bed, known as boarding, is increasing in American hospitals.
    • “One in four admitted patients spent at least four hours waiting in the E.R. for a bed in September 2024, up from one in eight in September 2017.
    • “Studies show that patients stuck boarding in the E.R. face a higher risk of worse care and early clinical deterioration.”
  • Fierce Pharma informs us,
    • “Heading into Halloween weekend, both Novo and Lilly saw scripts for their oral obesity medicines tick up. 
    • “In its 30th launch week, Lilly’s Foundayo racked up roughly 65K prescriptions, seemingly topping a record of more than 64K scripts set in week 25 of the rollout, according to IQVIA data cited by Jefferies. Still, the medicine’s performance pales in comparison to Novo’s Wegovy pill at week 30 of its own launch, when the semaglutide tablet reeled in roughly 173K scripts. 
    • “For the last weekly period, the Wegovy pill charted a 0.5% script increase—or around 8K new prescriptions—to land at around 184K total. That’s roughly on par with the height of the pill’s script performance in 2026 so far and marked a rebound from roughly 183K the prior week. 
    • “Novo reported earlier this week that the Wegovy pill generated 5.39 billion Danish kroner (nearly $811 million) in third-quarter sales. Over the same period, Lilly reported $184 million in sales of Foundayo. 
    • “On an analyst call, Novo’s EVP of U.S. operations, Jamey Millar, resurfaced caveats with the data IQVIA is using to track the oral GLP-1 launches, arguing that Novo boasts “a much more extensive ecosystem of partners for Wegovy” than Lilly, and that those partners “don’t report to IQVIA in absolute terms.” 
    • “So we’ve consistently seen a lower capture rate for Wegovy pill than the competitive oral product,” he suggested. 
    • “Based on the latest weekly metrics, Lilly holds a little more than a 26% share of the overall oral obesity market compared to Novo’s nearly 74%, the Jefferies team said in its note.” 

Midweek report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare–

“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From the national election front,

  • The Wall Street Journal reports.
    • “Vice President JD Vance blamed the Iran war for Republicans’ heavy midterm losses, saying “everyone knows why we lost.” The comments came a day after Democrats took control of the Senate and House in a blue wave that surged across the country, extending into traditionally red states in a repudiation of President Trump.
      • House: As more races are called, Democrats are expanding the majority they clinched in the chamber last night. [As of this writing, the Democrats have 237 seats and the Republicans 147.] Meanwhile, with House Speaker Mike Johnson saying he wouldn’t run for minority leader, House Republicans are already jockeying for the job.
      • Senate: Democrats have flipped seven seats so far in the Senate. [As of this writing the Democrats have 54 seats and the Republicans 44.] Two races have yet to be called in which the Democratic candidate currently has a slight edge over the Republican incumbent: Alaska and Mississippi. It’s unclear when those results will be announced.
      • Trump: The president appeared at the site where his ballroom is being constructed and took a few questions from reporters. Among other things he said Vance’s assessment of the impact that the war with Iran had on the midterms was “largely true” and that he wasn’t considering replacingDefense Secretary Pete Hegseth.
  • Beckers Hospital Review tells us,
    • “Health insurer and hospital stocks climbed Nov. 4 after Democrats won majorities in both chambers of Congress in the Nov. 3 midterm elections, as analysts said the new Congress could delay Medicaid cuts and restore enhanced ACA subsidies.”
  • Fierce Healthcare lets us know in more depth “what Democratic control of Congress means for healthcare in 2027.”
  • Beckers ASC Review points out “Physicians who won in the 2026 midterms.”

From the U.S. Office of Personnel Management front,

  • Govexec reports,
    • “Following the drubbing of congressional Republicans in Tuesday’s midterm election, federal employee unions are hopeful that the change in control on Capitol Hill will precipitate action to roll back some of the Trump administration’s efforts to reshape the federal workforce.”
  • Fedweek tells us,
    • “The annual federal benefits open season starting next Monday (November 9) and running through December 14 provides an opportunity for current enrollees change FEHB/PSHB health insurance plans’ change levels of coverage, for plans that have more than one; and change among self-only, family and self plus one options.” * * *
    • “Even enrollees happy with their same coverage should look at the offerings, experts advise, since benefits do change somewhat year to year. And within the average premium increase there is variation, with some plan premiums increasing by well more than the average.
    • “A summary of general changes to coverage terms in both programs is here; check a plan’s brochure for its specifics. OPM’s main open season resources page is here.
    • “Tables of plans leaving the programs or reducing service areas are here for FEHB and here for PSHB. Affected enrollees in these plans who don’t choose a new one will be moved to Compass Rose Standard if in FEHB and in FEP Blue Focus if in PSHB.”
  • and
    • “While most of the attention focuses on the FEHB health insurance program during the annual benefits open season—this year November 9-December 14—the open season also provides federal employees and retirees the opportunity to elect or change vision and/or dental coverage in the FEDVIP program, and for employees to begin or renew flexible spending accounts for the new year.” * * *
    • “Those who wish to have a dependent care and/or health care flexible spending account must make a new election during the open season. The IRS has not yet announced the maximums in those programs for 2027; for 2026, they were $7,500 individually or for a couple filing federal income taxes jointly ($3,750 for married individuals filing separately) for dependent care accounts and $3,400 (individually) for health care accounts.” * * *
    • “The open season does not apply to the other two federal insurance programs, the FEGLI life insurance program and the FLTCIP long-term care insurance program. FEGLI conducts open seasons only rarely, although new enrollments or coverage changes are allowed in certain circumstances at other times. The FLTCIP has not accepted new applications for enrollment or changes in existing enrollment since 2022; there has been no indication of that suspension being lifted.”
  • FedSmith discusses “Preparing for Medicare: FEHB Decisions at Age 65
    • “Learn how Medicare and FEHB work together at 65. Understand Medicare Part A, Part B, and make smart retirement healthcare decisions early.”

From the Medicare front,

  • Beckers Hospital Review notes,
    • “On Jan. 1, 2027, Medicare’s negotiated prices for 15 more drugs take effect, including the semaglutide products Ozempic, Wegovy and Rybelsus. They join the 10 drugs whose first-round negotiated pricestook effect this year. For hospital pharmacies, the date matters twice: several of the same drugs also move to rebate-only 340B pricing that day if the program takes effect as scheduled.”

From the U.S. Food and Drug Administration front,

  • STAT News reports,
    • “Democrats’ landslide victory in the midterm elections may have significant implications for the upcoming negotiations over a key funding source for the Food and Drug Administration, in part by empowering a major critic of the program.
    • “The FDA collects user fees from pharmaceutical companies to fund the agency’s reviews of their medicines. The Prescription User Fee Drug Act must be renewed before the current law expires on Sept. 30. Otherwise, it could disrupt the FDA’s ability to approve medicines.
    • “The power to shape that legislation will fall to senior Democrats, including Sen. Bernie Sanders (I-Vt.), who will likely lead the Senate’s health committee. Sanders is one of the few lawmakers who have opposed the core premise of the user fee structure.
    • “Now, he will have a chance to fundamentally alter how the FDA interacts with the companies it regulates.” 
  • Cardiovascular Business relates,
  • Contemporary OB/GYN shares professional “reactions to FDA’s boxed warning removals for menopausal hormone therapy.”

No Surprises Act News

  • The New York Times reports,
    • “The federal government plans to end contracts with two arbitration firms that settle medical billing disputes under the No Surprises Act, a consumer protection law that has come under scrutiny for high payouts for doctors.” * * *
    • “The arbitrators’ contracts last five years, and the government is now reviewing those awarded in 2022.
    • “Two firms, Island Peer Review Organization and Network Medical Review Company, were notified on Wednesday that the government does not plan to renew their contracts, according to a notice published that day.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Lung cancer remains the leading cause of cancer death in the U.S. and sits at the intersection of several pressures health systems are already managing: an aging patient population, uneven access to screening and a disease that is still most often caught too late. 
    • “How lung cancer affects a health system depends heavily on where it operates. Incidence, mortality, screening and smoking rates, along with Medicare spending, vary widely from state to state.
    • “For healthcare leaders, those state-level differences can inform decisions about screening programs, patient volume and investment in early detection.
    • “Becker’s compiled a list of the facts and figures healthcare leaders need to know about lung cancer using data from the American Cancer Society, the CDC, CMS and a lung cancer screening study published Dec. 9, 2025, in CHEST.”
  • and
    • “Hawaii and Louisiana continue to report the highest percent of influenza-like illnesses as the U.S. experiences an earlier-than-usual flu season.
    • “The CDC defines influenza-like illness, or ILI, as a fever of 100 degrees or greater, along with a cough and/or sore throat. The agency collects data on outpatient visits to healthcare providers for respiratory illness through ILINet. ILI percentages are weighted for state population and compared to baseline levels to assess flu activity. For more information on how the metric is calculated, click here.
    • “Hospitals reported 6,100 new flu admissions in the week ending Oct. 24, up from 4,811 the week prior, according to the CDC’s latest FluView report. This accounts for a 27% week-over-week increasein flu admissions. 
    • “About 2.4% of outpatient visits involved patients with respiratory illness. This metric sits below the national baseline of 2.9% and is up from 2.2% the week prior.”
  • The Washington Post relates,
    • “Peanuts, and peanut butter in particular, are some of the most ubiquitous elements of a child’s diet, and so when a kid is allergic to them, it can be a unique vexation for parents. It means no PB&Js for lunch — but also an endless list of logistics, from having to check in with the parents any time their kid goes over to a friend’s house to communicating with school officials.
    • “It turns out that for many kids thought to have peanut allergies, much of that vigilance may not be necessary. 
    • “A new peer-reviewed study, published Nov. 4 in the Journal of Allergy and Clinical Immunology: In Practice, suggests that fewer young children than previously thought have long-lasting peanut allergies. The findings could change how we make early-childhood allergy diagnoses and how to think about treating allergies moving forward.”
    • “Tim Brettig, a pediatric allergist and immunologist, and a senior research clinician at the Murdoch Children’s Research Institute in Melbourne, Australia. said that means many parents who think their children have lifelong allergies to peanut butter might want to reexamine the matter carefully. “If you’ve had a clear reaction, I would be less inclined to accept a peanut allergy diagnosis,” said Brettig, one of the lead researchers on the new study. “I’d want to continue that work-up. I think food challenges should play a greater role in the allergy assessment of children. Give them a chance to prove that they’re not allergic.” 
    • “The key is a controlled environment, such as a doctor’s office, for checking again, Brettig said. About 12 percent of the babies given the oral food challenge did experience anaphylaxis, the whole-body and sometimes life-threatening reaction that is the most severe response to an allergen. But because they were in an environment with medical professionals to administer care, no long-term harm came to any of the children. “It’s not necessarily something that I’d be doing in a community setting,” said Brettig. “You’d want it to be done with specialists that are skilled in performing these food challenges.”
  • The New York Times adds,
    • “Kratom, long used by people seeking relief from addiction to prescription opioids and alcohol, is increasingly being pitched as a wellness product that purports to raise energy, sharpen focus and enhance athletic performance.
    • “Some makers of kratom, a substance that is derived from the leaves of a tropical tree and often sold in the form of drinks, powder or capsules, have distributed free samples at gyms. Others have sponsored sporting events or trumpeted the product’s benefits with the help of social media influencers and wellness podcasts.
    • “What this marketing often fails to acknowledge is the potential for kratom to lead to addiction, liver injury, seizures and in some cases, fatal overdoses.”
  • Healio tells us,
    • “Individuals with inflammatory bowel disease who have at least two first-degree relatives with colorectal cancer appear to have the greatest increase in risk for CRC, according to results of a Swedish cohort study.
    • “Analysis also showed that having a relative with early-onset CRC was associated with a more modest risk, a finding that diverges from prior research.”
  • Health Day informs us,
    • “Gestational weight gain (GWG) outside of recommended ranges is associated with increased severe maternal morbidity (SMM) risk, according to a study published online Oct. 22 in JAMA Network Open.
    • “Sahar Khademioore, from McMaster University Medical Center in Hamilton, Ontario, Canada, and colleagues examined the association between GWG and SMM across prepregnancy body mass index (BMI) categories.”
  • Per an NIH news release,
    • “Results from a clinical trial funded by the National Institutes of Health (NIH) in five major United States cities show that delivering integrated HIV and substance use disorder (SUD) services using peer navigation in mobile medical units reduced all-cause deaths by 71% compared to participants who received peer navigation to community-based services alone. While scientists found no difference in the use of daily, oral preexposure prophylaxis (PrEP) and medication for opioid use disorder (MOUD) between the groups, the secondary outcome of reduced mortality was significant. 
    • “Injection drug use is an important contributor to HIV in the U. S. that also increases risk for other serious infectious diseases,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA), which funded the study. “Although we have effective interventions for this population, there are significant barriers to their accessibility and use. Nonetheless, these findings suggest that delivering low threshold services through mobile units could save lives.” 
  • Beckers Behavioral Health adds,
    • “Researchers at St. Louis-based Washington University School of Medicine found that among patients presenting to the emergency department with a substance-related problem, cannabis was most common among adolescents while alcohol was most common among older adults. 
    • “The study, published Nov. 4 in The American Journal of Psychiatry, analyzed data from large health insurance databases for more than 1.3 million patients ages 16 to 64 who had at least one substance-related emergency care visit between January 2016 and December 2023. Researchers analyzed the data by age group and substance used.” 
  • BioPharma Dive points out,
    • “Sanofi has stopped development of an experimental protein-degrading immune disease drug licensed from biotechnology company Nurix.
    • “Nurix on Tuesday revealed Sanofi’s decision to scrap “SAR448272,” an oral medicine designed to eliminate STAT6, a protein involved in many inflammatory conditions. Nurix didn’t specify the reason for the decision, but Sanofi separately told analyst firm Leerink Partners “emerging nonclinical findings … didn’t warrant further development” in eczema, according to a note to investors. 
    • “Nurix received a $10 million payment from Sanofi in August when a Phase 1 study began and would’ve been eligible for additional payouts if the treatment moved forward in testing.”
  • and

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

  • The Wall Street Journal reports,
    • “CVS Health raised its full-year guidance on gains in its health-care benefits and pharmacy segments, but said it remains cautious amid high costs and potential macroeconomic headwinds.
    • “The outlook comes after the company said Tuesday that it plans to split in two, with one company housing its insurance giant Aetna and pharmacy-benefit manager Caremark, and the other its 9,000 retail pharmacies.
    • “CVS said the breakup, slated for early 2028, will enable the two separate management teams to focus more on their respective businesses and be more agile, The Wall Street Journal reported.
    • “For the current fiscal year, the company on Wednesday said it now expects adjusted earnings of at least $8.20 a share, up from its previous forecast of between $7.90 and $8.10 a share. Analysts polled by FactSet anticipate adjusted earnings of $8.05 a share.
    • “CVS also said it now projects revenue of at least $420 billion for the year, compared with its previous forecast of at least $414 billion. Wall Street is modeling for revenue of $417.7 billion.
    • “Each of our businesses delivered another quarter of strong results,” Chief Executive David Joyner said. “We continue to advance our strategy by improving the consumer experience, lowering health care costs, and connecting care for the people we serve.”
  • and
    • “Novo Nordisk raised its annual guidance due to an improved outlook for its key obesity and diabetes drugs.
    • “The Danish drugmaker now expects adjusted sales and operating profit to range from a 2% decline to 2% growth at constant exchange rates.
    • “Third-quarter sales of the Wegovy pill reached the equivalent of $807.2 million, beating analyst expectations of 4.5 billion kroner.”
  • and
    • “AstraZeneca recently made a roughly $10 billion offer to buy Rhythm Pharmaceuticals RYTM 28.04%increase; up pointing triangle, according to people familiar with the matter, a deal that would expand its portfolio of rare disease treatments. 
    • “The U.K. pharmaceutical giant offered to pay $124 a share for the biotech last month, the people said. 
    • “Rhythm specializes in treatments for metabolic conditions and severe obesity. Its shares were trading Wednesday afternoon at around $95 apiece before The Wall Street Journal reported on the offer. They closed up 28% at over $110 a share following the report, giving the company a market value of roughly $7.6 billion. AstraZeneca had a market value of close to $300 billion.”
  • Beckers Hospital Review lets us know how “Health system CEOs close margin gaps with operational redesign.”
  • Fierce Healthcare informs us,
    • “As health plans and employers contend with a growing array of virtual care and AI-enabled tools, Amwell is positioning its digital health platform as the infrastructure layer for AI-enabled care.
    • “Executives at Amwell, formerly known as American Well, touted the company’s platform strategy, government contracts and higher-value clinical services as the main drivers of future growth during the company’s third-quarter earnings call Tuesday.
    • “Rising healthcare costs are pushing health plans and employers to adopt tech-enabled care solutions, but they are looking for measurable engagement and outcomes from digital health vendors, not just access, according to Ido Schoenberg, M.D., Amwell chairman and CEO.
    • “The proliferation of point solutions, accelerated by AI, is creating more vendor sprawl and member confusion, Schoenberg told investors and analysts during the call.” * * *
    • “This is the problem Amwell is determined to solve for our customers. We help them improve clinical and financial outcomes. We do it through activation, getting more of their members into technology-enabled care in place of conventional care that often costs more. We give our customers one platform under their brand with one integration. It provides reliable, scalable rails to bring in a program, exchange data with it, and tests whether it works. The member’s experience stays consistent, simple, and engaging. A common data structure proves the outcomes and improves performance over time,” he said.
    • “As AI adoption grows, a unified care platform becomes more valuable, Schoenberg asserted.”

Weekend update

David Ermer–Congress, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, Obesity, U.S. Healthcare–

“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From Washington, DC

  • The mid-term elections campaign trail ends on Tuesday, which is Election Day. Both the House and the Senate return to Capitol Hill next for a lame duck session.
  • Roll Call reports,
    • “Republicans in both the Senate and House will hold their leadership contests on Nov. 10, just a week after a high-stakes Election Day that will determine whether they keep their majorities.” 
  • Beckers Health IT relates,
    • “U.S. Sen. Bill Cassidy, MD, R-La., has released a discussion draft of the PATIENT AI Act, proposing to clarify whether the FDA or ONC oversees healthcare AI tools and to create a federal payment pathway for AI-based services.
    • “The Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care Act comes from Dr. Cassidy, who chairs the Senate Health, Education, Labor and Pensions Committee. AI applications that don’t qualify as FDA-regulated devices would be added to the definition of ONC’s certified health IT.
    • “The FDA would get a risk-based review process for software-based devices, including authority to accept premarket software changes and review updates on a rolling basis. HHS would certify third-party bodies to review low- to moderate-risk software. The Oct. 29 draft also applies existing federal preemption of state product liability laws to integrated and software-based devices.
    • “On reimbursement, HHS would build a coverage evaluation framework for AI-based services, propose payment methodologies and establish a process to use Healthcare Common Procedure Coding System Level II codes for them. The Center for Medicare and Medicaid Innovation would test a payment model for AI applications that deliver care autonomously.”
  • The Street tells us,
    • “A rare pricing shift is coming for Medicare beneficiaries in 2027, but taking advantage of potential savings will depend on the coverage decisions they make before the December 7, 2026, enrollment deadline.
    • “Medicare Advantage premiums are expected to fall next year, while Medicare Part B premiums are projected to rise more modestly than some retirees may have feared, according to the Centers for Medicare and Medicaid Services (CMS). 
    • “Prescription drug coverage, however, comes with a higher annual out-of-pocket limit and deductible in 2027.”
    • “Meanwhile, major insurers are reducing their coverage in some areas, leaving certain counties and limiting provider choices while cutting extra benefits like dental care in some regions.”‘
  • FEHBlog Observation — The FEHBlog’s guess is that CMS will announce 2027 Part B and D premiums shortly after Election Day.
  • The New York Times lets us know “What to Know About the 6 Experimental Peptides Kennedy Has Cleared for Use.
    • “Patients will now have widespread access to the peptides, despite experts’ safety concerns.”

From the public health and medical / Rx research front.

  • MedPage Today reports,
    • “As Measles Outbreak Hits Pennsylvania Amish Country, More Show Openness to Vaccines.
      • “— After a decline in trust, some minds are changing.
  • Health Day relates,
    • “No single exercise is best for weight loss, and varying workouts helps prevent progress from stalling
    • “Cutting calories drives most weight loss, but regular activity is key to keeping the weight off
    • “A sports doctor recommends pairing 30-minute cardio sessions with strength training that targets the legs and large muscles.”
  • and
    • “Low-risk prostate cancer (PC) has become less common at diagnosis since 2010, and low-risk patients are increasingly avoiding treatment, according to a study published online Oct. 26 in Cancer.”
  • and
    • “A vaginal swab test in development could help some women with abnormal bleeding avoid a painful uterine biopsy
    • “Early company-reported results suggest the swab catches at least 90% of endometrial cancers
    • “Developer PinkDx hopes to offer the test by mid-2027, pending results from a larger 3,000-woman study.”
  • The New York Times tells us,
    • “Knee Surgery Isn’t Always the Answer. Here’s How to Avoid It.
      • “If you want to avoid the knife, you have to be patient.”
  • and
    • “Why Your Mental Health Needs an Annual Checkup, Too
      • “Here are a few questions to ask yourself — and your primary care doctor — to keep your psychological well-being on track.”
  • Medscape informs us,
    • “For many problem drinkers, the after-work drink is automatic. Now, some patients of Sylvie Stacy, MD, tell her they pour a glass, take a sip or two, and walk away.
      “That sense of anticipation isn’t there anymore, and the situations that used to trigger an immediate craving for alcohol suddenly feel very neutralized to them,” said Stacy, an addiction medicine specialist and chief medical officer for Rehab.com.
    • “Why? These patients are using GLP-1 medications.”
  • and`
    • “In a small pilot trial, adults who had lost weight while they were on a GLP-1 receptor agonist (GLP-1 RA) and then stopped it regained less weight over 4 months with either a digital wellness app or dietitian-developed meal deliveries compared with usual care.

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

  • Modern Healthcare reports,
    • “Hospital units dedicated to treating the nation’s sickest kids are disappearing nationwide. In the past year alone, hospitals have closed pediatric intensive care units for critically ill kids in Montana, Oregon, and Missouri. Overnight hospital wings for kids have also shuttered in Illinois and California.
    • “Depending on the hospital, pediatric units — which are separate from neonatal intensive care units — can serve patients ranging from a few weeks old to well into their teens or early adulthood. As hospitals look to cut costs, many are converting those beds into more services for newborns or adults. As a result, pediatric intensive care has become centralized in medical hubs, requiring critically ill children to travel farther for lifesaving care.
    • “You can’t expect that people will be fine if the next-closest children’s hospital is a flight away or an eight-hour drive,” said Elizabeth Mack, a pediatric critical care doctor and spokesperson for the American Academy of Pediatrics.
    • “Hospitals cutting pediatric care tend to cite low patient volumes; it’s relatively rare for a child to need intensive care. It’s also hard to find doctors to treat those rare cases because the nation is short on pediatric subspecialists, who earn less than those focused on adults. Meanwhile, hospitals are often paid less to treat children than adults, and buying gear tailored to kids adds extra costs.
    • “The gap in care is acute in rural places. Cutbacks are happening across community hospitals, whether owned by small nonprofits or massive private equity companies.
  • Beckers Physicians Leadership relates,
    • “San Ramon, Calif.-based Hill Physicians Medical Group has agreed to have the Santa Clara County Independent Practice Association join its enterprise, according to an Oct. 29 news release.
    • “As part of the deal, Hill Physicians would also acquire the IPA’s management services organization, Pacific Partners Management Services, from an affiliate of HCA Healthcare. The addition would bring about 1,000 physicians and other providers into Hill Physicians’ network and give it a presence in all nine Bay Area counties.
    • “Hill Physicians is Northern California’s largest independent physician association, with more than 6,000 physicians serving more than 400,000 patients across 14 counties. The deal is subject to regulatory approvals, and financial terms weren’t disclosed.”
  • Beckers Health IT informs us,
    • “When Dallas-based Baylor Scott & White Health and Thrive Global, the behavior change technology company founded and led by Arianna Huffington, announced their collaboration in October, they set out to help people make healthier decisions about sleep, food, movement, stress and connection through what Ms. Huffington called “microsteps.”.
    • “For Ms. Huffington, supporting people through microsteps between doctor visits is an important part of moving healthcare beyond treating illness.
    • “One of our mottos is that health is also what happens between doctor visits. If we don’t nail how we can help people sleep better, eat better, move more, stress less and connect more, it’s going to be very hard to transform what is really a sick care system into a healthcare system,” she told Becker’s in an interview alongside Pete McCanna, CEO of Baylor Scott & White.
    • “Mr. McCanna said the idea resonated with him when he heard Ms. Huffington describe Thrive Global’s approach at a dinner, because it fit with the system’s effort to redefine what a modern health system should be, one he described as customer-centric and demand-driven.”
  • Fierce Healthcare informs us,
    • “Building on its recent guidance for organizations’ use and governance of clinical AI, the American Medical Association on Thursday gave a deeper breakdown of how it believes different parties should be responsible for decisions, actions and failures involving the technology. 
    • “The latest framework from AMA’s Center for Digital Health and AI addresses liability issues the group said are currently unanswered by existing liability frameworks. Those structures, it said, could leave physicians facing “liability for risks they cannot reasonably prevent, while patients may struggle to seek remedies when AI causes harm.”
    • “Other key issues with the status quo liability frameworks, AMA said, are ambiguity around when product liability applies to AI; how contract terms and disclaimers from developers can distance responsibility from risk control; and whether deploying healthcare organizations hold various responsibilities specific to AI, such as local testing or outcomes monitoring. 
    • “AMA said the clinical AI liability framework it’s advancing “recognizes that multiple parties may bear liability for the use of AI when something goes wrong,” and then aligns that accountability based on a party’s ability to prevent harm. Responsibility is spread out in areas where control is shared, but it does not become interchangeable, and no party’s obligations disappear because another party also bears some,” AMA wrote in a brief outlining its thinking.” 

Tuesday report

David Ermer–ACA, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Beckers Hospital Review reports,
    • “Thirteen Senate Democrats are demanding answers from the largest ACA marketplace insurers about their involvement in recent [ACA federal marketplace] coverage terminations that cut more than 760,000 people from their health plans.
    • “The Oct. 26 letters, led by Sen. Ron Wyden, D-Ore., and Sen. Bernie Sanders, I-Vt., accuse the insurers of “quietly colluding” with the Trump administration on what the lawmakers said was an improper process to terminate qualified enrollees without sufficient notice or compliance with consumer protections.”
    • It’s worth adding the Administration claims the 760,000 people were unauthorized enrollments.
  • and
    • “House Democrats introduced a bill Oct. 22 that would lower Medicare’s eligibility age to 50 from 65.
    • “The bill comes from Reps. Pramila Jayapal of Washington, Chris Deluzio of Pennsylvania, Debbie Dingell of Michigan and Pat Ryan of New York. Provisions would generally go into effect six months after enactment.
    • “Millions leave the workforce before 65, and with Trump’s cuts to healthcare, many are now left without any options as they wait, sometimes years, for Medicare enrollment,” Ms. Jayapal said in an Oct. 23 news release. “Expanding this program is a commonsense step towards ensuring that all Americans have the care they deserve.”
    • “If passed, the bill would sunset five years after most of its provisions go into effect.” 
  • The American Hospital Association News relates,
    • “The Department of Health and Human Services Oct. 27 announced a new initiative to improve breast cancer screening and detection efforts. The initiative, led by the Office on Women’s Health, the Agency for Healthcare Research and Quality, and DenseBreast-info.org, will coordinate actions that include expanding breast density education and improving diagnostic follow-up. HHS said more than 40 health systems will expand evidence-based practices and address delays in care under the program, called the OWH-AHRQ Breast Cancer Screening and Diagnostic Follow-up Initiative. The department said OWH and DenseBreast-info.org will also expand access to educational resources to improve breast density awareness, support informed discussions between women and healthcare providers, and promote understanding of breast cancer screening and diagnostic follow-up options.”
  • and
    • “The Department of Health and Human Services Oct. 26 announced that more than 250 hospitals have signed its voluntary pledge related to hospital efforts on healthy food. The pledge asks hospitals to align patient food services with the 2025-2030 Dietary Guidelines for Americans. It also asks hospitals to ensure inpatient meals meet individual nutritional needs and support healing, recovery and long-term health; and to provide accessible nutrition resources and education as part of discharge planning to help patients sustain healthy habits. The pledge was announced during the AHA Annual Membership meeting in April.”
  • Per an Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today released new analysis from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) examining America’s record-low overall age-adjusted death rate in 2025 and substantial progress in reducing prescription opioid exposure and expanding treatment. An article in Health Affairs Forefront and a new ASPE report highlight how actions across President Trump’s two terms to reduce unnecessary opioid prescribing, combat illicit fentanyl, and strengthen treatment and recovery have led opioid-related deaths in the United States to plummet to the lowest since President Trump declared a public health emergency in 2017. HHS Secretary Robert F. Kennedy, Jr. announced the findings at an event at Detroit Wayne Integrated Health Network in Detroit, Michigan.” * * *
    • “The ASPE report The U.S. Age-Adjusted Death Rate Reached a Record Low in 2025: What Drove the Decline? can be found here.
    • “The Health Affairs Forefront article can be found here.”
  • Beckers Clinical Leadership tells us,
    • “CDC deputy director and chief medical officer Jennifer Shuford, MD, is leaving the agency after six months, The Washington Post reported Oct. 26.
    • “Dr. Shuford, an infectious disease physician, previously served as Texas’ health commissioner and was hired in April as part of a new leadership team meant to increase trust in the agency. CDC scientists were optimistic about her hiring due to her public health background and willingness to speak out during Texas’ measles outbreak last year, the Post reported.
    • “She is expected to leave after the midterm elections Nov. 3.”

From the U.S. Office of Personnel Management front,

  • Federal News Network reports,
    • “Agencies now have explicit authority to put federal employees on paid administrative leave for “workforce realignment” reasons, according to final regulations the Office of Personnel Management published earlier this month.
    • “Paying federal employees not to work, after they agree to leave their jobs during workforce reduction efforts, is now an officially acceptable use of paid administrative leave under OPM’s final rule. The leave category is also permissible during reduction-in-force (RIF) notice periods, as well as physical fitness activities in limited cases. And agencies can now deny employees’ requests to withdraw their resignations while under a deferred resignation program (DRP).
    • “The regulations provide more transparency and accountability, provide a firmer legal foundation for allowing or prohibiting certain uses of administrative leave, promote consistency across agencies, clarify the authority of agencies and reduce potential disputes,” OPM wrote in its Oct. 19 final rule.”
  • Govexec relates,
    • “Americans’ satisfaction with public-facing services provided by the federal government has fallen for the first time in five years, according to new findings released by the American Customer Satisfaction Index.  
    • “ACSI reports that citizen satisfaction has fallen to a score of 68.6 out of 100 – a 2.6% decrease. 
    • “This marks the first decline tracked by the index since 2021, when many federal employees were put on mandatory work-from-home schedules at the height of the COVID-19 pandemic and agencies struggled to bring more of their public-facing services online.” 
  • FedSmith advises “Check your FEHB plan’s provider network before Open Season to ensure your trusted doctors, hospitals, and pharmacies are still covered.
  • OPM’s Inspector General has posted its Fiscal Year 2027 Oversight Plan, which is worth a gander.

From the U.S. Food and Drug Administration front,

  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Food and Drug Administration, today issued a draft guidance for industry to help sponsors develop and seek approval for personalized gene therapies designed to treat patients with rare genetic diseases.
    • “The guidance, Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management, provides a clear regulatory framework for submitting and managing Biologics License Applications (BLAs) for individualized genome editing (GE) products. The Trump Administration is committed to modernizing approaches to safely get more cures and meaningful treatments to all Americans, regardless of the size of the patient population.” * * *
    • “A recorded webinar, Individualized Human Genome Editing Products: Considerations for BLA and Postapproval Management, summarizing the key elements of the guidance is available on the FDA’s YouTube channel.
    • “The FDA is inviting public comment on the draft guidance. Comments may be submitted to the docket FDA-2026-D-11783 at regulations.gov within 30 days of publication in the Federal Register.”
  • Health tells us,
    • “A popular plant-based butter has been recalled in 10 states due to yeast, mold, and E. coli, the Food and Drug Administration (FDA) announced. The Miyoko’s butter was initially recalled on Sept. 11, and on Oct. 23, the FDA gave the recall the second-highest risk level, Class II. This means the butter is unlikely to cause permanent health issues, but may cause temporary or reversible effects.”
  • Cardiovascular Business adds,
    • “Medtronic is recalling certain OmniaSecure defibrillation leads due to an increased risk of implant issues. No adverse events have been reported, but clinicians did report experiencing difficulties that could potentially lead to “tissue trauma.” 
    • “The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall, which means using the devices “may cause temporary or medically reversible adverse health consequences.”
    • “Medtronic initiated the recall in September, notifying customers that they should “quarantine and return” any affected OmniaSecure defibrillation leads.
    • “Medtronic recently requested the retrieval of a subset of nonimplanted OmniaSecure defibrillation leads for an engineering evaluation,” a company spokesperson told Cardiovascular Business. “The notification request for retrieval was limited to a subset of leads that may have undergone a specific manufacturing sequence as identified by an internal quality process. There have been no reports of patient harm.”
    • “This recall covers more than 700 OmniaSecure defibrillation leads distributed throughout the United States. The two item numbers are 3930M74 or 3930M79. Only the leads specifically included in this recall are being recalled. Click here for a list serial numbers.”

From the judicial front,

  • Bloomberg Law reports,
    • “Novo Nordisk A/S lost a bid in a US court to temporarily block Eli Lilly & Co. from using advertisements that claim its drugs are more powerful, a setback to Novo as it battles to regain a larger share of the obesity and diabetes drug markets.
    • “US District Judge Zahid Quraishi ruled Monday that Lilly can continue to make the disputed claims in its ads while Novo proceeds with a lawsuit filed in July in federal court in Trenton, New Jersey. The judge said Novo’s case for a preliminary injunction was “less than persuasive” because it failed to show irreparable harm.”
  • Fierce Healthcare relates,
    • “CVS Heath’s Aetna is joining the ranks of insurers suing over its results in the 2027 Medicare Advantage star ratings.
    • “The insured filed suit Monday in Georgia’s Southern District Court, and argues that 28 measures used by the Centers for Medicare & Medicaid Services to calculate its scores were “unlawfully adopted” and should have been excluded.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “A single mutation in the H1N1 influenza virus — G155E — is emerging as the defining feature of a flu season that has arrived months ahead of schedule and may slip past some people’s immunity, researchers told Nature, CNN and Today. 
    • “Becker’s reported Oct. 5 that H1N1 had overtaken H3N2 in early West Coast surveillance. The mutation now drawing scrutiny helps explain why.” * * *
    • “Because this year’s shots were formulated in the spring, before G155E spread, the H1N1 component may not be well-matched if the mutation dominates, Dr. Bloom told Nature, though he cautioned it is too early to know. 
    • “Scott Hensley, PhD, a virologist at the University of Pennsylvania in Philadelphia told Nature the H3N2 and influenza B components appear well-matched. Experts stressed that a mismatch means reduced protection, not none. 
    • “This is one of those seasons where the key message is to go get vaccinated now,” Dr. Greninger told CNN. He added that a second, more conventional wave could follow once H1N1 peaks.”
  • and
    • “The CDC found four drug-resistant pathogens require urgent and aggressive action, according to its 2026 Antimicrobial Resistance Threats Report.
    • “The 2026 report, published Oct. 27, estimates the impact of 19 drug-resistant bacterial and fungal pathogens on human health in the U.S. They are categorized into three threat levels. Urgent threats require urgent and aggressive action. Serious threats require prompt and sustained action, and concerning threats require careful monitoring and prevention action, the report said. The CDC also included a watch list of pathogens being monitored because their full burden is not yet understood. 
    • “The CDC updated its methodologies and data sources to make the 2026 report the most comprehensive to date. As a result, direct comparisons to previous reports should not be made, the CDC said.”
  • and
    • “Older adults who received two weeks of home-delivered meals post-discharge were 69% less likely to be readmitted within 14 days, a Durham, N.C.-based Duke University study found.
    • “The study, published on Sept. 19 in Journal of Hospital Medicine, analyzed data from 368 adults 60 and older who were discharged from Duke hospitals between September 2022 and April 2024. All the adults were at risk of food insecurity or malnutrition and were referred to a state-funded Meals on Wheels hospital discharge pilot program that provided two weeks of home-delivered meals. 
    • “Meal recipients also had 54% lower odds of readmission at 21 days. Two weeks post-discharge, nearly 5% of patients who received meals were readmitted, compared with roughly 13% of those who did not.” 
  • Health Day relates,
    • “Ultra-processed foods appear to rewire kids’ brains so they crave more junk food, a new study says.
    • “Pictures of cookies or fries trigger a powerful reaction in the brain reward systems of children who eat more ultra-processed food, researchers reported Oct. 23 in JAMA Network Open.
    • Those children subsequently have higher odds of weight gain and more body fat, researchers found.
    • “Children’s brains are still developing, habits are still forming and food preferences are still being made,” senior researcher Dr. Kathleen Page, a professor of medicine and pediatrics at the Keck School of Medicine of USC, said in a news release. “It’s an important period where the brain is very sensitive to food and the food environment.”
  • and
    • “Nearly 1 in 5 young adults in the U.S. feel anxious every single day, a new study says.
    • “Just under 20% of Americans between 18 and 25 said they suffered from daily anxiety in 2024, up from 15% in 2020, researchers report in the American Journal of Public Health.
    • “The odds of receiving an anxiety diagnosis or a prescription for anxiety meds also rose by roughly a third during the same period, researchers found.
    • “This anxiety might stem from the COVID-19 pandemic and its lasting impact on the psyche of Americans, researchers said.”
  • Genetic Engineering and Biotechnology News tells us.
    • “A study by researchers at the Centre for Genomic Regulation (CRG) has identified six different genes that can help forecast survival of patients with acute myeloid leukemia (AML), a type of cancer that has very variable outcomes between patients.
    • “Headed by ICREA Research Professor Luciano Di Croce, PhD, a researcher at the CRG, the team created a scoring system by moving repeatedly between laboratory experiments with mice and patient records, crossing the two to look for genes that behaved consistently in both. * * *
    • “Findings from the study could point to new ways of helping to predict outcomes in patients with this type of blood cancer, contributing to the development of future prognostic tests, and may suggest new therapeutic targets. Patients suspected of having AML already give a bone marrow sample for laboratory analysis, and measuring six genes is simpler and cheaper than reading a broader genetic profile.”
  • The New York Times informs us,
    • “Millions Use Antidepressants. We Still Don’t Understand How They Work.
      • “Here’s how psychiatrists like me think about the most promising hypotheses.”
  • Fierce Pharma points out,
    • “Vanda Pharmaceutical’s Nereus may soon break out of its motion sickness niche to become a treatment option for the burgeoning GLP-1 market. 
    • “Topline results from the D.C.-based pharma’s phase 3 called “Study 3601” are in, and Nereus demonstrated a 27% reduction in vomiting among patients on GLP-1 receptor agonist therapy and a 35% reduction in severe nausea and vomiting.
    • “Nausea and vomiting are among the biggest obstacles to GLP-1 adherence. Roughly half of patients quit the treatments within their first year, and gastrointestinal challenges are among their cited reasons. Vanda believes Nereus has the potential to help more patients stay on their therapy. Data in hand, the drugmaker is now heading for the FDA in hopes of a label expansion.”
  • and
    • “Pfizer’s Elrexfio has taken another step on its path to potential commercial momentum: The drugmaker just announced another phase 3 win for the bispecific antibody, this time as a treatment for patients with relapsed or refractory multiple myeloma (RRMM) whose disease has progressed after first-line treatment.
    • “The topline readout, announced Tuesday, came by way of Pfizer’s MagnetisMM-32 trial, one of multiple ongoing phase 3 trials evaluating Elrexfio as an earlier-line option for RRMM. 
    • “According to Pfizer, patients who took Elrexfio after at least one prior line of treatment had a significantly lower risk of disease progression or death compared to an investigator’s choice regimen of BMS and AbbVie’s Empliciti (elotuzumab) with Bristol’s Pomalyst (pomalidomide), Pomalyst with Takeda’s Velcade (bortezomib), or Amgen’s Kyprolis (carfilzomib), all paired with the steroid dexamethasone.” 
  • MedTech Dive adds,
    • “Abbott on Monday launched a new version of its Oncodetect molecular residual disease test designed to better monitor for traces of cancer in the body after treatment.
    • “MRD tests look for tiny amounts of circulating tumor DNA, or ctDNA, in the blood to act as an early warning signal for cancer recurrence. The goal is to detect recurring disease earlier than traditional methods like imaging scans.
    • “Abbott’s new test, based on technology developed at the Broad Instituteof MIT and Harvard, uses whole-genome sequencing to track as many as 5,000 patient-specific cancer mutations, compared with up to 200 variants in the earlier Oncodetect test.”

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

  • The Wall Street Journal reports,
    • “Centene CNC raised its full-year outlook for the third time as the health insurer continued to control medical costs.
    • “However, its total at-risk membership fell to 25.7 million as of Sept. 30, down from 28 million a year earlier, primarily reflecting a contraction in its Health Insurance Marketplace enrollment.
    • “The company’s health-benefits ratio, a measure of how much was paid out to cover enrollees’ medical expenses, held steady at 92.7%, below the mean analyst estimate of 92.9%, based on FactSet. The company said the underlying performance in its Medicare Advantage and Prescription Drug Plans drove the stability, alongside improved pricing and risk transfer in Marketplace reflecting member acuity.”
  • and
    • “GSK expects to nearly double the number of cancer medicines it is testing in clinical trials next year, according to one of its top scientists, highlighting how the company’s dealmaking spree is filling its drug pipeline.
    • “Hesham Abdullah, head of oncology research and development at the U.K. drugmaker, said in an interview that the company is firing on all cylinders to speed up its return to the field of cancer medicine.
    • “Right now we have five approved [cancer] medicines, I think probably in a few weeks’ time there’ll be six,” Abdullah said. “We have a clinical-stage portfolio of about 15 assets that’s probably going to, I would say, close to double in 2027.”
  • Fierce Healthcare relates,
    • “HCA Healthcare’s earnings landed above internal and analyst expectations for the third quarter as accelerated volume growth and cost reductions blunted a weakening payer mix.
    • “On Tuesday morning, executives at the country’s largest for-profit health system said it’s now on track to land in the upper half of its 2026 estimated guidance ranges, and in an earnings call gave an early prediction that earnings performance next year “will be generally consistent with 2026” despite expected policy and macroeconomic headwinds. 
    • “I’ve often mentioned that HCA has strong staying power because of our scale, the important role we play in providing critical services to communities and our disciplined culture,” CEO Sam Hazen said during the call. “Despite the challenges this year brought about by federal policy changes, we have continued to move the company forward and believe we are positioned to end the year positively as we look ahead to 2027.”
  • Beckers Hospital Review tells us,
    • “King of Prussia, Pa.-based Universal Health Services reported an operating income of $454 million (9.6% margin) in the third quarter of 2026, down from a $522 million operating income (11.6% margin) during the same period last year, according to financial results published Oct. 27. 
    • “The news release comes after UHS completed its acquisition of Talkspace, a virtual behavioral health company, in mid-August for $835 million.” * * *
    • “UHS comprises 30 inpatient acute care facilities, 388 inpatient behavioral health facilities, 169 outpatient and other facilities, nationwide virtual behavioral health services, an insurance offering, a physician network and various related services with locations in 40 states, Washington, D.C., Puerto Rico, Ireland and the United Kingdom. It has more than 102,000 employees.”
  • and
    • “Healthgrades released its 2027 Specialty State Rankings Oct. 27, naming the top three or five hospitals in each of 19 specialties across 30 states.
    • “The rankings use Medicare inpatient data from 2023 to 2025 on 31 conditions and procedures. To be ranked, a hospital must have no one-star ratings and at least one five-star rating in the cohort being measured. States with six or fewer eligible hospitals in a specialty are not ranked in that specialty, states with seven to 10 eligible hospitals receive a top three and states with 11 or more receive a top five. This year’s ranked specialties include emergency hospitalization, which was not ranked last year and covers 12 common emergency conditions.
    • “The 30 states with rankings are Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.”
    • The article lists those hospitals by State.
  • and
    • “Pharmacist pay swings by tens of thousands of dollars depending on the state. Technician pay is lower and depends heavily on local cost of living. Meanwhile, the jobs themselves are shifting out of retail and into hospitals, where pay tends to be higher.
    • “[The article shows] what pharmacy pay looks like in 2026, based on the latest federal wage data.”
  • BioPharma Dive informs us,
    • “Ferring Pharmaceuticals has agreed to buy fertility treatment startup Gameto in a potentially $1.4 billion deal that boosts the Swiss drugmaker’s portfolio of reproductive medicines. 
    • “Ferring didn’t disclose exactly how much it’s paying up front for Gameto in its announcement Tuesday, only noting that the transaction involves payments tied to unspecified development, regulatory and sales milestones. The two entities will also continue to operate independently until the buyout closes. 
    • “Once completed, the acquisition will hand Ferring “Fertilo,” a novel technology the biotech developed to help simplify and shorten in vitro fertilization cycles.” 
  • and
    • “Artiva Biotherapeutics will lay off most of its staff and stop developing an experimental “natural killer” cell therapy for autoimmune conditions after reporting the deaths of two participants in a clinical trial. 
    • “Artiva made clear in a Tuesday statement that both of the deaths appear unrelated to its therapy, which is known as AlloNK and was being tested in inflammatory diseases like rheumatoid arthritis.” 
  • Beckers Health IT points out,
    • “Anthropic has acquired Mithril Medicine, a one-person startup developing treatments for two rare forms of muscular dystrophy. The AI company also released early results from Claude-assisted drug development work with six outside organizations, it said Oct. 27.
    • “The partners are BigHat Biosciences, Bristol Myers Squibb, Divergence Labs, Enveda, Generate Biomedicines and the Column Group. Most of the work is still preclinical, meaning most of the drug candidates have not yet been tested in humans.”

Weekend report

David Ermer–Agentic & Generative AI, Congress, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Congress remains on the campaign trail this week.
  • Per an October 23, 2024 Department of Health and Human Services news release,
    • “The Trump Administration today announced the America First Seafood Strategy, Restoring American Seafood Competitiveness [PDF], a coordinated federal plan to strengthen American seafood production, modernize infrastructure, expand markets for U.S. fishermen and processors, and combat unfair foreign competition. The strategy advances President Trump’s Executive Order, Restoring American Seafood Competitiveness, and his commitment to rebuild America’s seafood industry, strengthen domestic production, and Make America Healthy Again by expanding access to nutritious, American-caught seafood as part of a healthy diet.” * * *
    • “The draft [FDA] guidance notes that U.S. origin statements should be fully substantiated. Ensuring the integrity of these statements helps protect both consumers and the producers who invest in American sourcing. For more information, visit Seafood.gov.
  • FedSmith reports,
    • “The Social Security Administration (SSA) announced on October 20 that it is including a new insert with Social Security cards mailed to newborns through its Enumeration at Birth program. The insert explains how parents can claim and manage a Trump Account, including how eligible children can receive a one-time $1,000 contribution from the Treasury Department.”
    • “The full announcement is available in SSA’s official release.”

From the U.S. Office of Personnel Management front,

  • FedSmith explains “How Starting an HSA This Open Season Can Cut Costs, Lower Taxes, and Build Savings.”
  • Yahoo Finance adds,
    • “A 62-year-old taking an overnight mail-processing job is choosing a paycheck, but the job works mostly as a health insurance plan. As of January 1, 2025, postal workers left the Federal Employees Health Benefits program for the Postal Service Health Benefits (PSHB) program. A non-career hire can join PSHB after an initial term, and the Postal Service pays most of the premium; after five years of career service and continuous enrollment, that subsidized plan becomes retiree coverage for life.
    • “A 62-year-old taking an overnight mail-processing job is choosing a paycheck, but the job works mostly as a health insurance plan. As of January 1, 2025, postal workers left the Federal Employees Health Benefits program for the Postal Service Health Benefits (PSHB) program. A non-career hire can join PSHB after an initial term, and the Postal Service pays most of the premium; after five years of career service and continuous enrollment, that subsidized plan becomes retiree coverage for life.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “No surprise, the arena-sized room was packed with ESMO attendees eager to see Georgina Long of the Melanoma Institute Australia present the intismeran INTerpath-001 study results. The unfortunate data leak on Thursday made her talk less dramatic, but at the end, she received extended applause and a limited standing ovation. 
    • Long summarized the intismeran results — a 42% reduction in the risk of disease recurrence and a 38% reduction in the risk of distant metastasis-free survival — as a “new benchmark for adjuvant treatment of melanoma.”
    • “More critically,” she added, “it establishes intismeran as a landmark advance in personalized cancer medicine.” 
    • “The full trial data will be published next month in the New England Journal of Medicine, Long also noted. 
    • “Inge Marie Svane of the University of Copenhagen, the discussant following the data presentation, was positive if not overly enthusiastic about the trial, describing the results as “compelling” and adding that they “mark a crucial moment for personalized cancer vaccines.”
    • “But Svane also pointed to a number of outstanding questions, including whether there would be a survival benefit with intismeran, and what exactly was driving the vaccine’s benefit — was it the specific targeting of the neoantigens, or was it the general immune boost that studies have suggested mRNA vaccines provide?
    • “She also took no position on the best way to treat the approximately 40% of higher risk melanoma patients enrolled in the study — a key debate with commercial implications. If intismeran is approved, it will compete against neoadjuvant immunotherapy, or treating patients before surgery. Svane laid out pros and cons of each approach, leaving the question of which will benefit patients more unanswered.”
  • Healio relates,
    • “A phase 3 clinical trial revealed that the investigational vaccine candidate — known as LB6V — showed more than 70% efficacy against confirmed Lyme disease, according to results presented at IDWeek.
    • “But, in the end, the drug failed to hit its primary endpoint.
    • “LB6V has a “clinically meaningful” efficacy, researcher Paul G. Auwaerter, MD, clinical director of the division of infectious diseases and professor of medicine at Johns Hopkins University School of Medicine, said during the presentation.” * * *
    • “I believe that LB6V is safe and has a favorable side-effect profile,” Auwaerter said.” * * *
    • “Auwaerter did not mention the drug’s potential approval or launch during his presentation.”
  • Genetic Engineering and Biotechnology News adds,
    • “The results of a preclinical study headed by researchers at Johns Hopkins University School of Medicine suggest that the Bacillus Calmette-Guerin (BCG) vaccine, which is widely used to prevent tuberculosis and treat bladder cancer, may also have properties that reduce the risk for dementia. BCG is a live, weakened vaccine made from an altered strain of the bacterium Mycobacterium bovis.
    • “The team found that in mice genetically engineered to develop biological symptoms of dementia (PS19 mice), those animals that received the BCG vaccine were less likely to show hallmark signs of the disease, such as neurofibrillary (tau) tangles (NFTs) in the brain, sustained immune cell activation, and memory loss compared to mice that received no vaccine. BCG-treated mice performed better in a novel object recognition test, and showed improved maintenance of body-weight and survival.
    • “Research lead William Bishai, MD, PhD, co-director of the Johns Hopkins Center for Tuberculosis Research, believes that myeloid cells in the central nervous system and brain are using information from BCG to recognize and help the body respond to the formation of plaques and tangles characteristic of Alzheimer’s disease and related dementias. Bishai said, “We’re hard at work trying to understand the detailed mechanism for how it works, but this research points to early clues that aspects of trained immunity are likely driving this response.”
  • Health Day lets us know,
    • “Jumping rope, stair climbing, power yoga, vigorous cleaning and gardening can all count as at-home cardio
    • “Adults should aim for 150 to 300 minutes of moderate or 75 to 150 minutes of vigorous activity weekly
    • “Short bursts of movement add up, so even climbing a few flights of stairs counts toward your weekly goal.”

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

  • pwc consulting informs us,
    • “American healthcare was built by local institutions and independent physicians, yet it is now evaluated on national cost trends, consistent quality, and compliance with standardized payment models, all while still being expected to deliver care locally and personally. That tension, not any single policy or technology, is the throughline behind every challenge in this paper.
    • “The system faces seven distinct but connected challenges, spanning consumer expectations, care coordination, innovation speed, regional divergence, chronic care, national infrastructure, and technology adoption.
    • “Each of these seven structural challenges have a clear historical parallel, from 19th-century public health reform to the rise of AI, showing these are patterns, not new problems.
    • “The real bottleneck isn’t invention, it’s adoption that challenges the conventional norms and barriers that keep proven solutions from reaching scale. Time and again, technology and care models have proven themselves years or decades before the system used them.
    • “The next era won’t be measured by activity, it’ll be measured by impact. The organizations that win will likely be judged by how much healthier people became, not how many visits, procedures, or dollars were logged along the way.”
  • Beckers Hospital Review reports,
    • “Duluth, Minn.-based Essentia Health reported a 1.2% operating margin in fiscal 2026, down from 2.2% a year earlier, as expenses outpaced revenue growth ahead of its proposed merger with Bloomington, Minn.-based HealthPartners.
    • “Essentia reported $42.3 million in operating income for the fiscal year ended June 30, down 41% from $71.6 million in fiscal 2025, according to its Oct. 14 audited financial report. 
    • “Operating revenue increased 6.4% year over year to $3.49 billion, while operating expenses rose 7.5% to $3.45 billion. Patient service revenue grew 7.1% to $3.41 billion, driven primarily by outpatient revenue, which increased from $2.48 billion to $2.67 billion. Inpatient revenue rose from $673 million to $702 million. Salaries, wages and benefits increased 6.3% to $2.02 billion, while supply expenses climbed 11.4% to $809.5 million.
    • “Essentia reported $281.8 million in nonoperating gains, up from $169 million in fiscal 2025, driven largely by investment gains. The system posted a $324 million in net income, compared with $241 million a year earlier.”
  • and
    • “Greensboro, N.C.-based Cone Health plans to acquire three pharmacy businesses in Reidsville, N.C., expanding its retail pharmacy footprint and adding long-term care pharmacy services.
    • “The agreement includes Carolina Apothecary, Belmont Pharmacy and Rx Care, which have served Rockingham County residents for decades. The deal is expected to close in early 2027, pending regulatory approvals and closing conditions.
    • “The businesses will become Cone Health Community Pharmacy locations, offering closer coordination between pharmacists and healthcare providers, competitive medication pricing and onsite vaccinations.’
  • Beckers Payer Issues adds,
    • “AI, new product lines, shrinking broker networks and increasingly self-directed consumers will reshape the health insurance landscape in 2027, according to two reports from Forrester published Oct. 14, which covered the global insurance and healthcare industries broadly.
    • “Here are the firm’s 10 health insurance industry predictions for next year:
      • “Half of the 10 largest payers will launch alternative health plans.
        • “Existing alternative health plan examples include UnitedHealthcare’s Surest and Health Care Service Corporation’s new Easify Edge product’.
      • “More than half of consumers will start their healthcare journey using public AI models (such as ChatGPT or Claude), with 42% of consumers polled by Forrester already using an answer engine for healthcare advice.” 
      • “A third of insurers will integrate agentic AI into customer experience, but most will not let it make binding coverage or claims decisions. Forrester pointed to Allianz’s Project Nemo as an example of how large payers are using agentic AI to automate analysis and orchestrate workflows.”
      • “AI agents, not physicians, will perform 20% of routine care check-ins.”
      • “GLP-1 adoption will reach 20% of Americans, inspiring new drug pathways.”
      • “At-home tests will become a new digital divide and increase healthcare inequities.”
  • Beckers Physicians Leadership tells us,
    • “Median pay for cardiologists 35 and younger fell about 19% in 2025, even as overall cardiology compensation reached a record high, according to an October MedAxiom’s 2026 Cardiovascular Provider Compensation and Production Survey.
    • “Early-career cardiologists earned a median $476,850 in 2025, down from $586,769 in 2024. It was the second straight annual decline for the group. Over the same period, overall median compensation per full-time cardiologist rose nearly 5%, to $727,712 from $694,954, and every cardiology subspecialty posted its highest median pay in the survey’s history. 
    • “MedAxiom described the decline as surprising, given how hard cardiology programs are working to recruit physicians. The report doesn’t collect starting salary data, so it uses physicians 35 and younger as a proxy for early-career pay.”

Cybersecurity Saturday

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

From the frontier AI front,

  • The American Hospital Association News reports,
    • “Two critical vulnerabilities have been discovered in Hypertext Preprocessor, or PHP, a widely-used open-source scripted language for web development, its creators announced Oct. 21. The vulnerabilities reportedly impact a majority of the world’s websites. The two issues can allow unauthenticated remote code execution. The notice advises all PHP users to download updates immediately, as all PHP installations serving web requests are at risk. The National Security Agency advised organizations to take their systems offline if an immediate update is not feasible, and that the agency will soon issue specific guidance. An AHA Cybersecurity Advisory released Oct. 21 provides additional details and recommendations.”
  • The Wall Street Journal explains why this is a frontier AI story.
    • “First, artificial intelligence heralded the Bugmageddon. Now it is triggering an all-hands-on-deck cyber emergency. 
    • “The creators of PHP, a technology that powers as much as 70% of the world’s websites, disclosed a critical security issue Wednesday that could be leveraged by hackers to take control of any system running its software. That would allow an attacker to steal information or launch a cyberattack on anyone visiting a hacked website.
    • “Security researchers found the vulnerability using AI. Now web administrators are scrambling to protect themselves from the vulnerability, which cutting-edge AI systems could quickly exploit.”
    • “Ryan Austin, a researcher at Calif, uncovered the flaws with help from GPT-5.6 Sol, one of OpenAI’s most advanced models, during an audit of PHP’s source code in August [2026]. OpenAI funded that and other audits, part of an effort by AI companies to help open-source projects address software vulnerabilities now being uncovered by artificial intelligence systems.
    • “The class of bugs had been hiding in PHP’s source code for years. A security researcher had flagged it as a problem area decades earlier, but the flaw had been considered too difficult to exploit and was largely forgotten, Duong said. 
    • “AI found a way. Austin figured out how to control the code that was running in the computer’s memory with as few as a few dozen requests to a server running PHP. On smaller systems, the hack takes just seconds. On more complex ones, it can take hours.” * * *
    • “PHP2Shell is “the most severe AI vulnerability that was ever found,” and one that was likely too complex to have been discovered without AI, said Ami Luttwak, Wiz’s co-founder. 
    • “Duong and the other researchers kept its existence a closely guarded secret while they worked on fixes, for fear that an AI-aided hacker might find and exploit it before they were done. 
    • “The patching effort was massive. There are close to 200 files being fixed and developers wrote over 10,000 lines of code during the process. 
    • “Eventually, a patch date was set: October 22. Then, the inevitable happened. News of the patch leaked out Tuesday, in a post to Hacker News, just under two days before the patch release.
    • “Dusch’s team decided to rush out the patch. On Tuesday, they warned the world to stand by and expect a critical security update on Wednesday [October 21].”
  • Bleeping Computer and Cybersecurity Dive add,
    • [BC] “Security researchers at Amazon Threat Intelligence say attackers began targeting the PHP2Shell flaws four days before security patches were released on Wednesday [October 21]. * * *
    • “According to Amazon, the first exploitation attempts began on Saturday, October 17 (four days before the PHP2Shell patches were released), and attackers deployed multiple proof-of-concept PHP2Shell exploits hours after disclosure from VPN IP addresses.
    • “The exploit attempt originated from an IP address associated with a commercial anonymization network. While the vulnerability was under embargo, the targeting of a honeypot from an anonymized IP address suggests the activity was conducted by a threat actor, though it remains unclear how the actor acquired exploit information prior to disclosure,” said AWS chief information security officer CJ Moses.
    • “The actual payloads and choices in anonymization infrastructure varied, suggesting these were multiple actors. Technical analysis is ongoing, and it’s unclear if any of these attempts would have succeeded in real-world systems.”
    • “Moses added the PHP2Shell vulnerabilities are “now being broadly exploited in the wild,” though it’s unclear how many attacks are successful, and warned that “defenders should not assume the public disclosure date is the earliest date of exploitation.”
  • and
    • [CD] “Security researchers warn that millions of websites remain at risk as exploitation attempts against two critical flaws in PHP have surged. 
    • “The vulnerabilities, tracked as CVE-2026-109618 and CVE-2026-109619, can enable an attacker to achieve remote-code execution. Each has a severity score of 9.2 out of 10. 
    • “Exploitation attempts have surged since the vulnerabilities were first disclosed, and researchers have uncovered threat activity from Potassium, a Mirai-derived botnet originally discovered in March. 
    • “Arctic Wolf said it observed an exploitation attempt that combined a “command-execution validation with a second-stage payload delivery.” 
    • “Two malicious binaries were identified within the payload hosting infrastructure, but Arctic Wolf said it did not find enough evidence to show successful downloading or execution. 
    • “Researchers from Sophos also observed threat activity linked to Potassium, but they were able to block an attack. An examination of the sample showed an updated and ‘significantly expanded’ version of the botnet variant, Sophos said.” 
  • Here is a link to the October 23 alert from CISA about the PHP vulernability.
    • “CISA has updated this Alert [originally published October 21] to: (1) provide a SIGMA detection rule to help identify potentially suspicious activity; (2) incorporate partner resources; and (3) reinforce existing mitigation guidance.“
  • Dark Reading offers expert guidance on mitigating the PHP vulnerability.
    • “Fixing the critical PHP flaws is not as simple as clicking “Update.” Here’s how to assess your risk, and what you can do to protect yourself.”
  • The Wall Street Journal observes,
    • “The pace and volume of the AI-powered attacks are starting to overwhelm the incident-response firms that respond to cyber breaches. Pundits are referring to the month as “Black October,” and many in the field are predicting more to come.
    • “We expect that there’s going to be a massive number of compromise disclosures in the coming weeks and months,” said Steven Adair, president of the cybersecurity firm Volexity.
    • “Incident responders such as Adair say that AI tools are now being used by nation-state hackers from China and Russia as well as criminals looking to steal data and install ransomware. 
    • “One of the tools they are using is a Chinese open-source hacking tool called Artex, which uses artificial intelligence to automate the process of breaking into a computer network. 
    • “This week Microsoft said that “threat actors across multiple geographic regions” were using Artex to speed up attacks on hundreds of companies. Earlier this month, a cyberattack used Artex to steal data on about 68,000 people from South Korean banks.
    • “Hackers are using AI for reconnaissance, to analyze vast swaths of data they steal and even to rapidly build exploit code that can be used to break into networks, said Sherri Davidoff, founder of the security consulting firm LMG Security.”

From the cybersecurity and law enforcement front,

  • Cyberscoop reports,
    • “A new bipartisan House bill would charge the federal government with developing formal guidance for defending AI models against distillation attacks.
    • “The AI Cyber Defense Act, shared exclusively with CyberScoop ahead of release, is sponsored by Reps. Pat Harrigan, R-N.C., and George Whitesides, D-Calif. It would direct the National Institute for Standards and Technology to develop voluntary industry standards and best practices for preventing distillation attacks from foreign entities from four countries: Russia, China, Iran and North Korea.
    • “In an interview, Harrigan told CyberScoop it is “incredibly expensive” for the U.S. AI industry to maintain its six-to-12 month lead over other countries, and distillation attacks give other parties an incentive to copy other models while keeping their own spending low.
    • “He said he believes countries such as China are making a strategic choice to hold back on full investment of their own AI industry, instead betting they can drift behind American companies as they perform the arduous and expensive research and development to advance the field.”
  • Beckers Health IT relates,
    • “HHS will keep HIPAA civil monetary penalties at 2025 levels and skip its annual inflation adjustment for 2026, the department said in an Oct. 21 Federal Register notice.
    • “The freeze traces to last year’s federal government shutdown. The Bureau of Labor Statistics did not produce October 2025 consumer price index data during the lapse in appropriations from Oct. 1 to Nov. 12, 2025. Federal agencies need that month’s data to calculate the yearly penalty multiplier, so no 2026 multiplier exists.
    • “The Office of Management and Budget canceled the 2026 adjustments for federal agencies in an April 17 memo. HHS’ notice cites that guidance.” * * *
    • “The current HIPAA ceiling is about 46% higher than the $1.5 million cap set under the 2009 Health Information Technology for Economic and Clinical Health Act.”
  • The Cybersecurity Hub Newsletter, writing in LinkedIn, informs us,
    • “The United States has ordered federal civilian agencies to remove DeepSeek technology from their information systems and exclude the Chinese artificial intelligence developer’s products from future procurement, widening restrictions on its role in government operations.
    • “A Department of Homeland Security notice made public on October 19 covers DeepSeek, affiliated companies and third-party products and services developed using DeepSeek implementations. The measure therefore reaches beyond the company’s chatbot to software supplied by other businesses that incorporates its technology.
    • “The official notice, scheduled for Federal Register publication invokes the Federal Acquisition Supply Chain Security Act of 2018. DHS says the decision followed a review of a Federal Acquisition Security Council recommendation and supporting evidence. Its stated scope concerns federal civilian procurement and information systems; it does not announce a nationwide prohibition on private use.”
  • Tech Target reminds us,
    • “The U.S. government is moving closer to requiring covered critical infrastructure organizations to report significant cyber incidents within 72 hours and ransomware payments within 24 hours. But for operators of industrial control systems, the challenge will extend beyond deadline compliance; they must first determine whether an incident has occurred, establish what was compromised and decide whether the data driving physical processes can still be trusted.”
  • Per Security Week,
    • “Effective and efficient use of complex agentic systems is important for all organizations, but recognizing, preventing and recovering from them going rogue could be an existential necessity.
    • “NIST, the NSA, and CISA recognize the increasing potential for AI agents to behave in an unexpected and potentially harmful manner, and has responded with a list of key practices for both preparing for and responding to such behavior. The report (Key Practices for Incident Readiness and Response in Super Intelligence Training and Evaluation) uses the term super intelligence (SI) rather than artificial intelligence (AI) in line with presidential executive order 14434.
    • “In the report, the ten key practices are grouped into five stages: prepare, detect, respond, recover, and report. For clarity, the report also includes three useful terminology definitions covering AI agents, AI control incident, and AI control near-miss.”
  • The National Institute of Standards and Technology announced
    • “The initial public draft (ipd) of NIST Special Publication (SP) 800-100r1 (Revision 1), Information Security Handbook: A Guide for Executive Leadership, is now available for comment.” * * *
    • “The draft covers:
      • “An overview of key NIST frameworks and how they relate to one another
      • “Governance, including risk management fundamentals and enterprise risk management
      • “Topics organized under the CSF’s Identify, Protect, and Detect/Respond/Recover functions
      • “Continuous monitoring strategy and roles
    • “A public comment review period is open from October 12 to December 4, 2026. Commenters are encouraged to use the comment template and submit feedback to sp800-100-comments@nist.gov.”

From the cybersecurity breaches and vulnerabilities front,

  • MedTech Dive reports,
    • “Quest Diagnostics is the latest medtech company to disclose that it was hit by a cyberattack.
    • “The testing services company identified unauthorized access to its Quanum Lab Services Manager system on Wednesday [October 21], according to a filing with the Securities and Exchange Commission. Quest’s Quanum LSM system is used by certain clients to place test orders as well as to receive and look up results. Quest paused access to the system upon discovering the incident.
    • “While Quest is still determining the full scope of the attack, it believes that an unauthorized party accessed certain patient records. Quest, in the filing, did not detail what patient records were accessed or how many records were involved.”
  • HIPAA Journal lets us know that “Data breaches have been announced [recently] by UltraMobile Imaging in New York, Artistic Smiles in Colorado, Parkview Health in Indiana, and Cognitive Behavior Therapy Center in Virginia.
  • Federal News Network fills us in about insider cybersecurity threats.
    • “Les Bernys, the executive director of the Department of Defense Cyber Crime Center, said the number of insider cyber incidents reported over the last six months far outpaced any other time in DC3 history.
    • “DC3 says more broadly, critical incident reports, which include insider threats, from defense companies have increased by over 50% in the last fiscal year. DC3 says it can’t give complete figures due to the anonymity of the DIB companies reporting.
    • Bernys said DC3 is seeing two kinds of insider threats.
    • “One type are former DoD employees who did malicious things to the network before they left or still have access to data after they left and were trying to exfiltrate data and, possibly, doing nefarious things with that data,” he said after speaking at the ACT-IAC Cybersecurity Summit on Oct. 14. “The second type of incident are companies are reporting that they have hired individuals who they thought were Americans but were North Korean. These incidents aren’t coming in huge numbers, but the increase is noticeable.”
    • “He added companies are struggling to better verify their applicants.”
  • CISA added eight known exploited vulnerabilities to its catalog this week
    • October 20, 2026
      • CVE-2026-96652 Plex Media Server Server-Side Request Forgery (SSRF) Vulnerability
      • CVE-2026-96654 Plex Media Server Improper Neutralization of Encoded URI Schemes in a Web Page Vulnerability
      • CVE-2026-96655 Plex Media Server Server-Side Request Forgery (SSRF) Vulnerability
      • CVE-2026-96656 Plex Media Server External Control of File Name or Path Vulnerability  
      • CVE-2026-106931 EG Secure Solutions SiteGuard Server Edition OS Command Injection Vulnerability
      • CVE-2026-110936 Siemens Software Center Uncontrolled Search Path Element Vulnerability
        • The Plex Medica Service KVEs are PHP Shell vulnerabilities discussed in the frontier AI section above. Bleeping Computer also discusses the KVEs here.
        • Cybersecurity News discusses the EG Secure Solutions KVE here.
        • The Hacker News discusses the Siemens KVE here.
    • October 23, 2026
      • CVE-2026-114625 Arista VeloCloud Orchestrator SQL Injection Vulnerability
        • Security Week discusses this KVE here.
    • October 23, 2026
      • CVE-2026-110447 Collabora Online – Built-in CODE Server OS Command Injection Vulnerability 
        • GitHub discusses this KVE here.
  • Bleeping Computer points out,
    • “GitLab has released security patches for a maximum-severity Regular Expression Compiler flaw that can let remote attackers run arbitrary code on vulnerable servers.
    • This security issue is tracked as CVE-2026-110264 and was reported by a security researcher using the ‘joaxcar‘ handle through GitLab’s HackerOne bug bounty program.
    • “CVE-2026-110264 stems from an integer overflow weakness in GitLab’s Regular Expression Compiler, a background engine that parses and validates regular expressions in configuration files.
    • “GitLab has fixed the vulnerability in GitLab Community Edition (CE) and Enterprise Edition (EE) versions 19.5.1, 19.4.3, 19.3.6, 19.2.9, 19.1.9, 19.0.10, and 18.11.13, and warned users to patch their instances immediately.
    • “GitLab has remediated an issue that, under certain conditions, could have allowed an unauthenticated user to execute arbitrary code on the GitLab server due to integer overflow when compiling a specially crafted regular expression,” the company said.”
  • Cyberscoop tells us,
    • “Microsoft researchers attributed the recent supply-chain attack targeting ConnectWise customers’ Microsoft 365 environments to a China-state aligned threat actor it tracks as Storm-0940.
    • “As early as September 2026, Storm-0940 used the agentic AI penetration testing framework ARTEX to automate attacks targeting hundreds of organizations globally across a broad range of industries,” Microsoft Security Research wrote in a blog postWednesday. 
    • “The nation-state group, which has been active since 2021, targeted organizations in aerospace and defense, automotive, chemicals, energy, financial services, government, legal, manufacturing, media, military, semiconductors, software, technology, think tanks and non-profits. 
    • “Storm-0940 initiated a widespread, but ultimately unsuccessful, password-spraying campaign immediately preceding the compromise of ConnectWise’s Cloud Backup service. During a four-day stretch ending Oct. 14, Storm-0940 targeted 327 Microsoft 365 and Exchange Online accounts across eight organizations, researchers said.”
  • Cybersecurity Dive informs us,
    • “An Indian company’s serious error in creating high-level encryption certificates has prompted major web browsers to block the certificates before hackers can use them to spoof websites.
    • “The issue involves intermediate certificates created by the Indian firm eMudhra, a company with the authority to issue certificates that are trusted by Google Chrome, Microsoft Edge, Mozilla Firefox and other browsers. Certificate issuers use intermediate certificates to “sign” individual website certificates that assure users of the sites’ legitimacy and security. But eMudhra recently failed to apply the proper procedures when creating eight of its intermediate certificates, producing keys that were shockingly weak.” * * *
    • “Leading web browsers responded by severing their trust relationships with the eight weak intermediate certificates. Google and Mozilla published blog posts detailing their responses to the discovery.
    • “Users should update their browsers and operating systems to the latest versions as soon as possible,” Dennis Jackson, a member of Mozilla’s cryptographic engineering team, wrote on an explainer page about the incident.
    • “There is no evidence that hackers generated any fraudulent website certificates by exploiting the weaknesses in eMudhra’s keys.”
  • and
    • “Threat actors are deploying agentic AI in more sophisticated ways to automate aspects of their hacking campaigns, according to CrowdStrike.
    • “In 2026, CrowdStrike Intelligence has documented several incidents in which threat actors used AI not only to create tooling or artifacts, but to conduct agentic campaigns in which AI agents make decisions and execute commands,” the security firm said in a report published on Wednesday [October 21].

From the ransomware front,

  • The American Hospital Association New reports,
    • “A joint advisory issued Oct. 20 by U.S. and international agencies warns of recent activity by the SafePay Ransomware group. The group has been active since 2024, attacking critical infrastructure organizations, including healthcare, across North America and around the world. The agencies said SafePay actors typically gain access to networks by stealing or guessing passwords, exploiting vulnerabilities in security systems and using phishing tactics. The actors then gain control of the network by creating new accounts or taking over existing ones and use legitimate system tools to move through the network to identify valuable files and disable security protections. Next, the actors encrypt the victim’s files and leave a ransom note demanding payment in cryptocurrency. The advisory includes recommended security measures to reduce the risk of SafePay ransomware attacks.”
  • Cybersecurity Dive adds,
    • “Palo Alto Networks researchers warned that ransomware operators have stepped up exploitation of a high-severity flaw in the company’s GlobalProtect portal, months after it was first disclosed. 
    • “The authentication bypass vulnerability, tracked as CVE-2026-0257, allows an attacker to establish unauthorized VPN connections to the remote-access product. The flaw has a severity score of 7.8 out of 10. 
    • “Researchers warn that Qilin and INC ransomware groups are exploiting the vulnerability, according to a report by Unit 42, the threat intelligence and incident response arm of Palo Alto Networks. The company tracks those groups under the names Spikey Scorpius and Tarnished Scorpius, respectively.” 
  • Info Security Magazine relates,
    • “Almost 3000 ransomware attacks took place between July and September 2026 and the figure marked a significant increase when compared with the same period last year.
    • “According to an analysis by Nord Security, the 2894 ransomware attacks which took place during the quarter represents a 50% increase when compared with the same period last year.
    • “It also represents a slight increase when compared with the previous quarter of this year, as the July to September period saw an 8.6% rise in ransomware attacks when compared with April to June.
    • “Published on October 21, the Nord Security report suggested that the significant rise in ransomware activity is a result of the impact of law enforcement takedowns on ransomware groups.
    • “Researchers suggested that the action against the likes of  Lockbit, BlackCat and RansomHubhelped to reduce ransomware activity during 2025.
    • “Now, the market is stabilizing, and the numbers we see today are merely the first stepping stone in ransomware’s new era,” said Vakaris Noreika, VP of product research and development at Nord Security.”
  • Acronis takes “a closer look at a not-so-gentle ransomware-as-a- service operation.”
    • “The Gentlemen uses a double-extortion model. In addition to encrypting files, the ransomware can exfiltrate data from compromised systems. This puts additional pressure on victims to pay the ransom to restore access to their files and prevent the stolen data from being publicly leaked.”
  • Tech Target offers a tip about
    • “How to tackle a ransomware readiness self-assessment, with template
      • “Ransomware readiness self-assessments are key to spotting vulnerabilities and preparing for third-party assessments. Use this template to evaluate your organization’s preparedness.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • “As businesses and consumers increasingly adopt artificial intelligence agents, 1Password is aiming to position itself to deliver solutions for growing challenges around security, access and trust.
    • “The Canadian late-stage cybersecurity startup has surpassed $500 million in annual recurring revenue, up from $400 million in November 2025, with a free cash flow margin in the double digits, the company said.
    • “The growth has been driven by an explosion in coding assistants and agents in enterprise settings, whose access to company secrets and systems needs to be closely managed, Chief Executive David Faugno said.
    • “The agents can actually take those secrets and do things that are unpredictable,” Faugno said in an interview. “You have to be very, very clear about what access you give it, and how you monitor and maybe even revoke that access, and humans have to stay in control.”
  • Cybersecurity Dive relates,
    • “The size of the cybersecurity insurance market is growing quickly as more businesses try to guard against the damage from a major hacking incident.
    • “Total U.S. domestic cyber direct written business has nearly tripled since 2020, making cyber insurance one of the fastest-expanding segments in insurance,” the National Association of Insurance Commissioners said in a statement Wednesday [October 21] about its new report on the topic.
    • “Chubb, Beazley and St. Paul Travelers are the top three insurers by the value of their direct written premiums, according to the report.”
  • Dark Reading adds,
    • “Cyber Insurance’s New Reality: Underwriting Isn’t Enough
      • “Rising AI, social engineering, and cloud risks are pushing carriers beyond risk transfer and deeper into cybersecurity itself.”
  • Cyberscoop warns,
    • “Encryption isn’t enough to protect data wherever it goes 
      • “Once data is in use, encryption falls short. A tested approach that replaces sensitive values with realistic substitutes could make stolen information far less useful to hackers.”
  • Per the Cybersecurity Hub Newsletter,
    • :Your SIEM detected the incident, Could you prove it six months later?
    • “That question comes up more often than it should. Usually during an audit.
    • “The incident was investigated. The threat was contained. The alert was closed. Six months later an auditor asks for the investigation record, the incident timeline, and the documentation showing what was reviewed and what was decided.
    • “The security controls worked. The paper trail did not.
    • “We put together the Managed SIEM Compliance Evidence Checklist for NIS2 and DORA to help teams find those gaps before a review does.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Beckers Payer Issues reports,
    • “The House Committee on Oversight and Government Reform announced an investigation into pharmacy benefit managers Optum Rx, CVS Caremark and Express Scripts Oct. 23, reviewing their auditing practices of independent pharmacies. 
    • “The investigation stems from concerns “that independent pharmacies have potentially been targeted for punitive audits in retaliation for their public support of legislation recently passed by the committee,” the committee’s chairman, James Comer, R-Ky., said.
    • “Under HR 6610, PBMs for Federal Employees Health Benefits Program plans would pay in-network pharmacies a benchmark price with a capped margin. The PBMs would also pay a dispensing fee that aligns with what the state Medicaid program pays. The Pharmaceutical Care Management Association, which represents PBMs, pushed back against the bill amid the committee’s July markup.
    • “Let’s understand this bill for what it is: a huge cash transfer from taxpayers to pharmacists and nothing more,” PCMA President and CEO David Marin said in a July 22 statement. “It makes providing health benefits to federal workers far more expensive, simply as a gift to one industry.”
    • “Mr. Comer said that since the July markup, several independent pharmacies that backed the bill received more audit notices than usual.”
  • The FEHBlog heartily agrees with PCMA. The FEHB and PSHB programs should not be treated like test subjects.
  • Beckers Hospital Review explains the “6 ways the federal government is going after drug prices.”and lists “Medicare’s proposed 2027 pay cuts, by specialty.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services has launched a new initiative to help recruit and retain nurses in nursing homes, the agency announced Oct. 23. Under the Nurses for Nursing Homes initiative, nursing students and licensed nurses interested in working in a nursing home could be eligible to qualify for up to $40,000 in student loan repayment and/or a $10,000 stipend in exchange for a three-year commitment to work in a qualifying nursing home in a rural or higher labor-shortage area. CMS said the $275 million program is expected to support more than 4,000 nurses nationwide and will be funded through civil monetary penalties collected by CMS and states from nursing homes. CMS has committed $100 million, while states are committing to at least $175 million. A website for the program includes details on eligibility requirements, open positions, details on how to apply and other information.”
  • and
    • “The Centers for Medicare & Medicaid Services Oct. 23 released a proposed rule implementing new Health Insurance Marketplace eligibility verification requirements enacted under public law 1, which was signed into law in July 2025. Beginning in plan year 2028, this proposal would require the Marketplaces to verify certain eligibility information before providing advance premium tax credits and cost-sharing reductions, particularly related to citizenship and lawful presence status; residency; non-employer-sponsored minimum essential coverage; and annual household income, family size and eligible noncitizen status. The rule also would require enrollees to provide or confirm key eligibility information annually to continue receiving financial assistance, essentially ending automatic reenrollment for enrollees receiving premium tax credits.  Comments are due 30 days after publication in the Federal Register.”
  • STAT News tells us,
    • “The Trump administration late on Thursday proposed a rule that would severely restrict future U.S. investment in the Chinese biotech sector but still allow American drugmakers to buy the rights to medicines invented in the country.
    • “The Treasury Department proposed the rule to implement a law, called the Comprehensive Outbound Investment National Security Act, that restricts U.S. investment in industries of concern to national security. The department added biotechnology to the list of industries subject to COINS restrictions, joining the likes of semiconductors, artificial intelligence, and quantum technology.
    • “The proposal would prohibit U.S. companies from entering financial transactions with Chinese biotech companies or Chinese manufacturers of biotechnology-related equipment and tools, according to the research firm Veda.
    • “We are surprised by the aggressiveness of the proposed rule,” Veda stated in a research note to clients. “Both in terms of its prohibition of all biotechnology-related transactions and the broadness of the definition of biotechnology.”

From the U.S. Office of Personnel Management front,

  • Kevin Moss, writing in Federal News Network, points out “What’s changing in FEHB for 2027 (and ways to save)” during the Federal Benefits Open Season which begins on November 9, 2026.
  • Fedsmith calls attention to benefit matters that federal and postal employees and annuitants may need to address before yearend.

From the U.S. Food and Drug Administration front,

  • Beckers Health IT reports,
    • “The FDA has issued its most serious recall classification for certain hospital glucose meters after a software issue that could cause test results to be assigned to the wrong patient was linked to one serious injury.
    • “The recall affects Nova Biomedical’s StatStrip Glucose Hospital Meter System Gen 2.0, a handheld device used by hospitals to measure patients’ blood glucose levels.”
  • Beckers Hospital Review adds,
    • “The FDA has warned Baxter International over significant manufacturing violations at its Baxter Healthcare drug manufacturing facility in Round Lake, Ill., including deficiencies involving contamination controls and sterile injectable production.
    • “The agency identified the violations during a March 23-April 2 inspection, according to a Sept. 29 warning letter. The FDA said environmental monitoring had detected cephalosporin in multiple areas outside the intended production area since January 2025 and cited deficiencies in Baxter’s monitoring program.
    • “The FDA also identified deficiencies involving aseptic processing, visual inspection of sterile injectable drugs and investigations into leaking products and sterility failures. The agency said Baxter’s current equipment, process and airflow design posed “excessive contamination risk.”
  • MedTech Dive relates,
    • “Edwards Lifesciences has won Food and Drug Administration approval for its Pascal Precision system for tricuspid valve repair, the company said Wednesday.
    • “Pascal’s expanded label covers use in patients with symptomatic severe tricuspid regurgitation. Edwards previously received FDA approval for the device in degenerative mitral regurgitation.
    • “The approval should expand the group of tricuspid repair patients that Edwards can treat, Leerink Partners said in a note to investors.”
  • PharmExec informs us,
    • “The FDA today approved a subcutaneous induction regimen for AbbVie’s Skyrizi (risankizumab-rzaa) in adults with moderately to severely active Crohn’s disease. The decision lets patients start treatment at home with an on-body injector (OBI) induction pack instead of an intravenous infusion and continue with the same device during maintenance.1
    • “AbbVie filed for the new regimen April 27 and had said it anticipated approval later in 2026. The decision changes how therapy begins, not who is eligible, because intravenous induction remains an option.1
    • “People living with Crohn’s disease need treatments that can deliver meaningful disease control from the start,” said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. “With the approval of subcutaneous induction, we are building on the strong efficacy of Skyrizi while giving patients and physicians greater flexibility in how treatment is initiated. This is one more example of how AbbVie continues to advance treatment to better meet the needs of people living with Crohn’s disease.”
  • Cardiovascular Business lets us know,
    • “Eko Health has received U.S. Food and Drug Administration (FDA) clearance for Core 300, a new artificial intelligence (AI)-enabled stethoscope that offers both traditional analog and advanced digital listening capabilities. 
    • “The Core 300 stethoscopes give clinicians the ability to instantly switch from traditional listening to digital listening when evaluating both pediatric and adult patients. The technology behind Eko Health’s digital listening capabilities includes up to 35x amplification, noise cancellation and real-time heart data that is then displayed on the device. 
    • “These stethoscopes can also be connected to the Eko App or Eko’s FDA-cleared AI models for additional benefits. In addition, the battery life was designed to last for weeks at a time.” 

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Oct. 23 announced that the submission period opened for petitions to deny the recertification of three independent dispute resolution entities. Members of the public, providers, facilities and others can submit a petition, which must identify the IDR entity seeking recertification and detail the reasons for the petition. The three organizations seeking recertification are National Medical Reviews Inc.; Keystone Peer Review Organization, Inc., which also does business as Acentra; and MCMC Services LLC. The petition period is open through Oct. 29. The departments of Health and Human Services, Labor, and the Treasury will make a final decision on recertification after reviewing any petitions submitted.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “Centene has become the latest insurer to sue the federal government over its 2027 Medicare Advantage star ratings.
    • “In a lawsuit filed Thursday in Georgia’s Southern District Court, the company argues that the Centers for Medicare & Medicaid Services violated the Administrative Procedure Act in determining its latest scores. Centene says that CMS ran afoul of “core statutory safeguards” in deploying 17 measures.
    • “The use of those measures ultimately caused “significant injury” to the company, according to the complaint. For 2027, 9% of Centene’s members are enrolled in plans with at least four stars, which declined from 18% in the prior year.
    • “In implementing each of the individual Star measures that Centene challenges, CMS violated applicable law and thereby caused Centene to lose out on hundreds of millions of dollars in revenue that Centene could use to strengthen benefits, reduce premiums, and improve health outcomes,” the company said in the lawsuit.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • RSV activity is very low in most areas of the country.
    • “COVID-19 activity remains elevated in some regions but is declining nationally.
    • “Seasonal flu activity is increasing in many parts of the country but remains low nationally.
    • “Rhinovirus/Enterovirus (RV/EV) is elevated nationally, and parainfluenza viruses (PIV) are increasing.”
  • Beckers Clinical Leadership adds,
    • “Hawaii, Florida and Louisiana are reporting the highest percent of influenza-like illnesses.
    • “The CDC defines influenza-like illness, or ILI, as a fever of 100 degrees or greater, along with a cough and/or sore throat. The agency collects data on outpatient visits to healthcare providers for respiratory illness through ILINet. ILI percentages are weighted for state population and compared to baseline levels to assess flu activity. For more information on how the metric is calculated, click here.
    • “Hospitals reported 4,811 new flu admissions in the week ending Oct. 17, up from 4,024 the week prior, according to the CDC’s latest FluView report. About 2.2% of outpatient visits involved patients with respiratory illness. This metric sits below the national baseline of 2.9% and is up from 2.1% the week prior.”
    • The article ranks the State by their ILI percentages.
  • and
    • “The CDC has now activated six emergency responses for pathogens in 2026 — the latest a level 3 response to a record dengue outbreak in Florida — a pace that underscores how many infectious disease threats are landing on hospitals and public health agencies at once. 
    • “From a fatal new spillover in France to a bird flu outbreak left uncontained on a U.S. mink farm, the past several weeks have handed infection prevention and clinical leaders a dense cluster of public health concerns.”
  • The American Hospital Association News tells us,
    • “There are now 1,338 confirmed measles cases in Pennsylvania this year as the state’s ongoing outbreak continues, according to the latest data from the Pennsylvania Department of Health. Of those, 255 individuals have been hospitalized. The agency said that more than 56,000 doses of the measles, mumps and rubella vaccine were administered by healthcare providers across the state in September, and more than 39,000 have been administered so far this month. Providers typically administer 25,000 doses per month, the department said. Nationally, there have been 4,588 confirmed measles cases this year, according to the latest update from the Centers from Disease Control and Prevention. The vaccination status of 96% of cases is unvaccinated or unknown.” 
  • The University of Minnesota’s CIDRAP reports,
    • “Two new studies underscore the importance of the hepatitis B virus (HBV) vaccine birth dose, with a US study predicting that dropping or delaying initial vaccination would drive up chronic infections and an Ethiopian study finding lower mother-to-child transmission (MTCT) with birth-dose receipt.
    • ‘After US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. panned the first study, as well as the New York Times’coverage of it, on X, experts quickly pointed out deficiencies in his objections.”
  • The Washington Post relates,
    • “While cigarette smoking is still the primary risk factor for lung cancer, a growing proportion of patients with the disease are nonsmokers like [Bryant] Lin [M.D.]. Last week, Pope Leo had part of his right lung removed because of adenocarcinoma, the most common type of lung cancer. He is not known to have ever lit up.
    • “The drop in smoking rates in the United States and other countries has unexpectedly shed light on this as an emerging health issue. Never-smoker lung cancer is now the eighth leading cause of cancer-related death in the U.S. and the fifth most common cause of cancer-related deaths worldwide.
    • “Because I’m a physician, most people make the assumption I’ve never smoked, and they ask, ‘Why did you get lung cancer?’” Lin said. “Then I explain to them that roughly one out of five people with lung cancer in the United States have never smoked.”
    • “A growing body of research is identifying the disease’s unique clinical characteristics. In September, a study described a rare mutation concentrated in the southeastern U.S. that puts never-smokers at 60 times higher risk of developing lung cancer. The demographics of patients are also distinct — for instance, women who have never smoked are more than twice as likely to get lung cancer as men who have never smoked.”
    • “Two-thirds of nonsmoking-related lung cancer happens in women, so there’s certainly an association with female sex,” said Jaclyn LoPiccolo, a medical oncologist at the Dana-Farber Cancer Institute and author of the mutation study. “Nonsmoking-related lung cancer is also more common in people of East Asian descent, but whether that’s a genetic or environmental association, we don’t yet know.” 
    • “Regardless of gender or ethnicity, risk factors include exposure to secondhand smoke, radon, air pollution and asbestos. A family historyof any cancer diagnosed before age 50 in a first-degree relative is associated with increased lung cancer risk in nonsmokers.”
  • Health Day points out,
    • “For patients with atrial fibrillation (AF) and acute ischemic stroke, early initiation of rhythm control is associated with a lower risk for recurrent stroke or systemic embolism (SE), according to a study published online Oct. 21 in Neurology.”
  • and
    • “Women who enter menopause prematurely may have a higher risk of heart problems, due in part to higher blood sugar levels, a new study says.
    • “Women with menopause that occurred before age 40 had higher rates of heart disease and insulin resistance, researchers reported Tuesday at the annual meeting of The Menopause Society.
    • “Our findings suggest that insulin resistance may be one important pathway linking premature menopause with increased cardiovascular disease risk, highlighting the importance of cardiometabolic health in women who experience menopause before age 40,” lead researcher Zailing Xing said in a news release. She is assistant professor of epidemiology at Florida A&M University.”
  • MedPage Today adds,
    • “Neurokinin (NK)-receptor antagonists improved sleep disturbances in menopausal women, a meta-analysis of randomized controlled trials showed.
    • “Among women with moderate-to-severe vasomotor symptoms, the agents were associated with improvements in sleep disturbance as early as 4 weeks (standardized mean difference [SMD] -3.94, 95% CI -5.71 to -2.16) compared with placebo, reported Maria Julia Lemos, MD, of Kurah Women’s Health Institute in Macaé, Brazil, and colleagues.
    • “This trend continued at 12 weeks (SMD -3.11, 95% CI -4.60 to -1.61) and 24 weeks (SMD -2.04, 95% CI -3.93 to -0.15), Lemos reported during a presentation at the Menopause Society annual meeting that was co-published in Menopause.
    • “For women with hot flashes who can’t or don’t want to use hormone therapy, especially when poor sleep is one of their main complaints, these drugs are a good option to consider,” Lemos told MedPage Today. “They may help women sleep better, not just have fewer hot flashes.”
  • Harvard Health notes,
    • “A new pill that dramatically lowers harmful LDL cholesterol may be a good option for people who can’t tolerate statins or who haven’t lowered their LDL enough despite their current treatment with cholesterol-lowering drugs.
    • “Approved by the FDA in July 2026, enlicitide (Lipfendra) is the first oral version of a class of drugs known as PCSK9 inhibitors. These drugs work by mimicking the effect of a naturally occurring variant in the PCSK9 gene that leads to very low LDL levels. But the original drugs — which are given by injection once or twice a month — aren’t widely used. Some people aren’t comfortable giving themselves an injection. Also, most insurance companies won’t cover the cost (which range from $200 to $500 or more per month) until a person has tried other therapies without success.
    • “Enlicitide is a daily pill that must be taken on an empty stomach with a sip of water, black coffee, or plain tea. It lowers LDL by nearly 60%, which is similar to the injectable PCSK9 drugs. Less than 10% of users experienced either dizziness or diarrhea, the two most common side effects. A month’s supply will cost about $300; for now, insurance coverage remains unclear.”
  • Per STAT News,
    • “A multiple sclerosis treatment from Novartis cut by a third the rates of relapses that people with the condition have compared to a standard treatment, data presented Friday show. While that efficacy doesn’t match the performance of a rival drug from Roche, Novartis’ treatment has a cleaner safety profile that could give it a shot at being competitive in the market.”
  • and
    • “A chemotherapy-free combination of Tango Therapeutics’ experimental drug vopimetostat and Revolution Medicines’ recently approved Rasonque shrank tumors in 82% of patients with advanced pancreatic cancer, early-stage data presented at ESMO show. The Phase 1/2 trial enrolled 22 heavily pretreated patients whose tumors harbor MTAP deletions, a genetic alteration found in roughly 40% of pancreatic cancers.”
  • Beckers Hospital Review adds,
    • “Bristol Myers Squibb said Oct. 23 a study participant died from septic pneumonia about six weeks after receiving a dose of a CAR-T cell therapy being tested for multiple sclerosis. 
    • “The phase 1 trial included 66 patients with highly active relapsing multiple sclerosis or progressive forms of multiple sclerosis. In the study, most adverse events were “brief and reversible,” according to BMS. 
    • “After receiving the CAR-T therapy, zolacabtagene autoleucel, 28 of the 66 participants experienced cytokine release syndrome events, or hyperinflammation. Six patients had immune effector cell-associated neurotoxicity syndrome, including one life-threatening case, which resolved within two to four days.”

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

  • Beckers Payer Issues reports,
    • “Blue Cross Blue Shield of Massachusetts and Burlington, Mass.-based Tufts Medicine are partneringon a new health plan for BCBS employees, as well as AI implementation to streamline prior authorization.
    • “The HMO, Tufts Medicine Alliance Network, includes access to Tufts Medicine, Boston Children’s Hospital and Dana-Farber Cancer Institute. The HMO also provides next-day primary care access and specialist access within 21 days, according to an Oct. 22 news release.
    • “BCBS told Becker’s that about 35% of its workforce lives within the plan’s region, and that the plan will be available during their open enrollment. BCBS and Tufts Medicine said they are considering expanding the HMO’s availability to other employers in the future and are collaborating on similar offerings.”
  • Fierce Pharma relates,
    • “Last week’s federal holiday, Columbus Day, led to an unsurprising dip for prescriptions of both Novo Nordisk’s Wegovy pill and Eli Lilly’s oral GLP-1 rival Foundayo in the U.S. 
    • “In the prior-week reporting period, Novo’s Wegovy pill saw prescriptions fall slightly to around 173K versus the 173.5K tallied the week ending Oct. 9, according to Citi and Jefferies analysts, both of whom leverage prescribing data from IQVIA.”
    • “For that same period, prescriptions of Eli Lilly’s GLP-1 pill Foundayo slipped around 4% week over week to 58K. 
    • “The minor reversal for both drugs shouldn’t come as a surprise, given that national holidays are liable to impact weekly prescribing trends. 
    • “Looking at the broader oral GLP-1 market, Lilly’s share presently sits a little higher than 25%, according to the Jefferies team, while Novo holds a nearly 75% piece of the pie. 
    • “Meanwhile, as Novo and Lilly vie over the ever-important U.S. obesity market, the GLP-1 opportunity taking shape across other massive countries like China, India and Brazil could grow from $6.6 billion now to a whopping $22 billion by the middle of the next decade, according to a new J.P. Morgan estimate reported by Reuters Friday.” 
  • MedTech Dive tells us,
    • “Qiagen said Wednesday it has agreed to a takeover offer from EQT Private Equity valued at 10.8 billion euros (about $12.1 billion), including approximately $1.1 billion of debt.
    • “The agreement comes less than two months after the testing company, long a rumored takeover target, installed Jonathan Pratt as its new CEO. Six years ago, Thermo Fisher Scientific was set to buy Qiagen, but the deal fell apart after shareholders objected to the price.
    • “William Blair analysts, in a Thursday note, said EQT’s all-cash offer of 46.50 euros per share (about $52.20) was reasonable, given Qiagen’s relatively lower growth profile.”
  • Beckers Health IT informs us,
    • “Philadelphia-based Jefferson Health’s ambient AI rollout was associated with up to 16.6% less after-hours documentation and up to 39.3% faster chart closure among its most active users, according to a study published Oct. 23 in NEJM Catalyst Innovations in Care Delivery.
    • “The analysis covered 5,234 clinicians with access to Abridge’s ambient documentation tool, which runs inside Jefferson’s Epic EHR. It also covered 283,028 ambulatory encounters with matched patient experience surveys from July 1 to Dec. 31, 2025. Use was voluntary, and about 34% of clinicians with access actively recorded visits.
    • “Results were reported in two cohorts that reflect the separate EHR instances of Jefferson and Allentown, Pa.-based Lehigh Valley Health Network, which merged in August 2024. Among 637 clinicians who met the usage thresholds, Epic Signal data comparing 12 weeks before and after adoption showed several declines. Time in notes per appointment fell 10.5% and 17.3%. “Pajama time” fell 8.9% and 16.6%. Time to chart closure fell 25.3% and 39.3%. Weekly progress note volume held steady or rose.”