Tuesday report

Agentic & Generative AI

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
  • Simplicity is a virtue.

From Washington, DC

  • The American Hospital Association News reports,
    • “The AHA Oct. 20 expressed support for the Addressing Boarding and Crowding in the Emergency Department (ABC-ED) Act (S. 1974), bipartisan legislation designed to improve data collection on hospital capacity and ED boarding. The bill is sponsored by Sens. Chris Coons, D-Del., and David McCormick, R-Pa. In its letter to the bill’s sponsors, the AHA emphasized that the causes of ED boarding and crowding are complex and have become persistent and growing challenges for hospitals and health systems nationwide.”
  • Beckers Payer Issues relates,
    • “A newly introduced House bill is targeting the methodology behind Medicare Advantage star ratings, adding more pressure to a program that has seen years of litigation from insurers.
    • “The Medicare Advantage Strengthening Transparency and Accountability in Rating Systems Act, or MA STARS Act, was introduced Sept. 21 by Rep. Mike Kelly, R-Pa., and would direct the federal government to rewrite star ratings policy beginning with the 2031 contract year.
    • ‘Under the bill, CMS would have to exclude any measure that is unrelated to clinical quality, outcomes or experience, or is not reasonably attributable to the actions of the plan and its delegated entities, such as contracted providers and subcontractors. Measures built on enrollee surveys would also be excluded if the survey has more than 10 questions, fails to draw responses from a diverse group, or misses minimum response and sampling standards set by HHS.
    • “Measures that no longer distinguish performance among most contracts would also come out of the calculations, while new measures could be added only if they relate to clinical quality, outcomes or experience.”
  • and
    • “As Medicare Advantage faces concerns regarding plan oversight, possible overpayments and care access, RAND researchers assembled experts to unpack potential reforms.
    • “Published in Health Affairs Oct. 5, the study consisted of two rounds with nearly 40 panelists. They rated 15 policy reform ideas on a nine-point scale. These ideas had high-level framing and were drawn from panelist suggestions and published research. The policy list was updated between the two rounds.
    • “While none of the proposed policies were found to simultaneously benefit all stakeholders — beneficiaries, plans and the government — the researchers identified the three “most feasible near-term reforms” that would benefit beneficiaries while not harming health plans and the government. These are standardizing supplemental benefits, limiting the number of plans an insurer can offer and reforming agent commissions.”
  • Medical Daily tells us,
    • “A senior federal health official has acknowledged that Medicare’s experiment with AI-assisted prior authorization is falling short. “There are a lot of things about WISeR that are not working,” Centers for Medicare & Medicaid Services (CMS) Deputy Administrator Kimberly Brandt said Oct. 15 at a conference in Santa Fe, New Mexico, Nextgov/FCW reported.
    • “The admission matters most for people with Original Medicare in the six states where the test runs: Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington.
    • “For older adults and their caregivers, the main issue is time. When a needed procedure waits on approval, pain, wound healing, and mobility can all suffer. Knowing how the system works can help families push for faster answers.”
  • Per Health and Human Services Department news releases,
    • “The U.S. Department of Health and Human Services (HHS) today launched the Kidney Care National Plan, a coordinated department-wide strategy focused on revitalizing American kidney care.
    • “As part of the Make America Healthy Again initiative, the new Kidney Care National Plan will address the root cause of disease and implement better treatments for Americans at every stage of kidney disease. The Plan identifies where federal action can improve kidney care across the entire spectrum of kidney disease, eliminate regulatory barriers to support innovation and a well-functioning kidney market, and deliver greater choice and superior outcomes to Americans.
    • “President Trump changed the course of kidney care in 2019 by challenging a system that waited for patients to reach kidney failure,” said HHS Secretary Robert F. Kennedy, Jr. “Now HHS is building on that work by detecting kidney disease earlier, expanding treatment and home-care options, removing barriers to innovation and transplantation, and strengthening safety across the transplant system. Our goal is simple: preserve kidney health, give patients more choices, and help more Americans avoid kidney failure and live longer, healthier lives.”
    • Link to the Kidney Care National Plan Fact Sheet
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced seven awards through its new Sickle Cell Disease Regional Care Excellence (SoRCE) Program. The awards establish Regional Coordinating Hubs to help people with sickle cell disease access high-quality care and community services closer to home.
    • “Americans living with sickle cell disease should not have to travel long distances or overcome unnecessary barriers to receive effective care,” said HHS Secretary Robert F. Kennedy, Jr. “Early treatment can prevent serious complications and help patients live healthier lives. The Trump Administration is expanding access to proven treatments and specialized care so more patients can get the support they need in the communities they call home.”
    • “Approximately 100,000 people in the United States live with sickle cell disease. Early and ongoing treatment can prevent or reduce serious complications, yet many people face barriers to preventive care, specialty services, and disease-modifying therapies. The SoRCE Program aims to improve access and quality of care while tracking indicators of quality of life.” * * *
    • “See the FY 2026 SoRCE Program award recipients.”

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

  • FedScoop has named OPM Director Scott Kupor one on its 11 FedScoop 50 2026 Golden Gov: Federal Executives of the Year. Congratulations Director Kupor.
  • Director Kupor added to his Secrets of OPM blog a post titled Free is Good which concerns open source software and super intelligence efforts.
  • The ABA Banking Journal reports,
    • “As the Office of Personnel Management considers possible changes to federal employee health benefits, it should create more opportunities for employees to select health savings account-qualified, high-deductible health plans, the American Bankers Association HSA Council said in a letter to the agency.”

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

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines. The guidance ends longstanding uncertainty by providing recommendations about when app content is subject to FDA submission requirements, when an app should be mentioned on a drug’s official label, and what companies should submit to the agency.
    • “Mobile apps are playing a growing role in how patients manage their medications and health conditions,” said Captain Chris Wheeler, Pharm.D., Director of the Division of Medical Policy Programs within FDA’s Center for Drug Evaluation and Research. “This guidance helps ensure that the information these tools provide is accurate, evidence-based, and clearly communicated to both patients and their providers.”
    • “The guidance addresses three key questions for industry: when app content is treated as FDA-required labeling versus promotional labeling, when an app should be referenced in a drug’s official prescribing information, and what companies should submit to FDA when they distribute app content to users.”
  • and
    • “The U.S. Food and Drug Administration yesterday approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week. The approval aligns with FDA’s Public Health Pillar: Increasing Access to Affordable Medicines & Medical Products.
    • “Menopause is a universal experience for women, and it can greatly affect a person’s quality of life. This approval makes effective treatment more accessible,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Approvals like this reflect FDA’s ongoing commitment to expanding American patient access to safe, affordable, high-quality medications.”
    • “The generic estradiol and levonorgestrel transdermal system is therapeutically equivalent to Climara Pro, which is indicated for use in women with an intact uterus for:
      • “Treatment of moderate to severe vasomotor symptoms due to menopause
      • “Prevention of postmenopausal osteoporosis.”
  • and
    • “The U.S. Food and Drug Administration today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis. Hibsago is the first FDA-approved antisense oligonucleotide to treat chronic hepatitis B. Hibsago is approved for certain adults without cirrhosis who have been taking HBV antiviral therapy for at least six months, have suppressed levels of HBV in their blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test. 
    • “For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Wendy Carter, DO, Acting Director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research. “Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.”

No Surprises Act News

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 20 published two qualifying payment amount audits under the No Surprises Act. The audits were of CareSource in Indiana and the School Employees Retirement Systemin Ohio, with both required to complete corrective actions following the audits. The CareSource audit focused on almost 25,000 claims, primarily concerning emergency and non-emergency services, while the School Employees Retirement System audit focused on six air ambulance claims. Both audits were conducted between Jan. 1, 2022, and May 31, 2023.”

From the fraud, waste and abuse front,

  • The Oklahoma Voice reports.
    • “Oklahoma’s Medicaid payment error rate is well below the national average, according to the agency that administers the program. 
    • “Oklahoma’s “improper payment rate” for Medicaid, also known as SoonerCare, was 0.15% in 2025 compared to the national average of 6.12%, according to the Oklahoma Health Care Authority.” * * *
    • “Oklahomans expect every taxpayer dollar to be spent the right way, and we hold ourselves to that standard,” said Aaron Morris, interim CEO of the Health Care Authority, in a statement. “We are continuously enhancing our tools to ensure Medicaid dollars are preserved and available to fund services for Oklahomans in need.”
    • “In 2022 Oklahoma’s Medicaid program had not yet made the switch to managed care, but overall, the state’s Medicaid error rate was 1.95%, the second lowest rate in the nation. * * *
    • “In the three years since the last review, the agency worked on “rigorous staff quality control and enhanced data integrity,” said Rebecca Sheppard, a spokesperson for the Health Care Authority. 
    • “The Health Care Authority is “continually adapting its strategy” to combat fraud through firewalls, automated application screenings and data validation exchanges with partners like Equifax, according to a news release. 
    • “OHCA’s broader plan to protect program integrity combines strict provider credentialing and revalidations of high-risk providers with targeted post-payment audits that verify medical necessity and proper documentation,” according to a news release.” 

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Flu season is off to an unusually early start, with wastewater surveillance, emergency department data and local health departments from Virginia to California all indicating increased virus activity. 
    • “An earlier-than-usual rise does not guarantee a worse season, but on nearly every surveillance measure — and in a growing list of states — the virus is proliferating.
    • “Thirty-eight states are seeing a “high” level of influenza A in wastewater, according to Wastewater SCAN, a dashboard developed by Stanford (Calif.) University. The 12 states still at a “low” level are clustered in the Midwest: Kansas, Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, Nebraska, North Dakota, South Dakota and Wisconsin.” * * *
    • “Officials across states are urging residents to get vaccinated by the end of October, noting the shot takes about two weeks to take full effect. El Paso County, Colo., is “seeing an earlier rise in higher numbers of flu,” public health official Haley Zachary told CBS affiliate KKTV, after the state reported its first pediatric flu death of the season. In Kentucky, where cases are running above last year’s level, EDs are already treating flu-like illness earlier than usual, CBS and The CW affiliate WKYT reported.”
  • Health Day relates,
    • “Food sensitivity appears to change as a child ages
    • “More kids become sensitive to food allergens as they grow older
    • “Peanut is an early and persistent allergen, but others become prominent by age five.”
  • and
    • “Epilepsy is strongly associated with young-onset dementia (YOD; age younger than 65 years), according to a study published online Oct. 14 in Neurology.”
  • Radiology Business tells us,
    • “Despite anxiety pertaining to the exam, many breast cancer survivors report high confidence in contrast-enhanced mammography (CEM) and would recommend it to other survivors as part of their post-treatment surveillance plan. 
    • “Survey findings published in Insights Into Imaging are offering new insight into how patients feel about having to complete CEM exams for monitoring purposes after cancer treatment. In recent years, the exam has emerged as a promising alternative to digital mammography, which has limited sensitivity in post-op patients.” 
  • Cardiovascular Business informs us,
    • “Researchers with NYU Langone Health may have identified a new way to predict heart transplant rejection without the need for an invasive biopsy. Their findings were recently published in the Journal of Heart and Lung Transplantation.[1]
    • “The study combined blood biomarkers with electrocardiogram (ECG) heart rhythm recordings into an artificial intelligence (AI) model and then compared the results directly against the gold-standard myocardial biopsy results. The team found the AI accurately identified when a transplant patient’s body starts attacking a donated heart.”
  • and
    • “Advanced artificial intelligence (AI) models can anticipate when older heart failure patients may start to experience functional decline, according to new findings published in the Journal of Cardiac Failure.[1]
    • “Researchers explored data from more than 6,000 patients 65 years old or older who were hospitalized for heart failure and prescribed rehabilitation. The median age of the cohort was 82 years old. An advanced machine learning model was then developed capable of evaluating a patient’s one-year risk of experiencing functional maintenance, functional decline or death. Functional decline was specifically defined as anyone who transitions to a housebound/ bedridden lifestyle due to their health.” 
  • Healthcare IT News adds,
    • “The relationship between clinicians and clinical knowledge is changing, according to a new JAMA study that suggests a “growing share of knowledge access is shifting from recall to retrieval.” 
    • “Researchers also say by characterizing the scale, distribution and clinical content of clinician-AI interactions, their findings fill an evidence gap needed to further frameworks that properly evaluate and guide AI use in clinical practice.” * * *
    • A significant number of medical practitioners are using AI in the clinic to explore treatment options for their patients in areas outside their clinical specialty, said Harvard in announcing the findings of what it’s calling the “first large-scale study of how often clinicians use artificial intelligence tools in patient care.”
    • “Harvard Medical School and Brigham and Women’s Hospital – along with researchers from Seattle Children’s Hospital, New York University’s Grossman School of Medicine, Massachusetts General Hospital and the National Bureau of Economic Research in Cambridge, Massachusetts – analyzed two-and-a-half years of OpenEvidence usage data. 
    • “The goal was to understand what types of clinicians are making queries, and how they are using the AI-driven findings. 
    • “Among 950,000 clinicians who submitted more than 270 million queries of artificial intelligence over a two-and-a-half-year period, queries were highest for nurse practitioners, followed by physician assistants and physician residents and fellows, according to the report, published Oct. 15.
    • “Use of clinical AI was also higher among physicians in oncology/hematology, internal medicine and family medicine and lower among those in ophthalmology, radiology, orthopedics and anesthesiology, said researchers from Boston-based Mass General Brigham in an email to Healthcare IT News.” 
  • BioPharma Dive points out,
    • “An experimental pill from Boston-based Rapport Therapeutics narrowly succeeded in a mid-stage study focused on bipolar mania, an outcome that analysts described as unexpected and a potential stepping stone to a billion-dollar-plus market.
    • “Rapport’s study enrolled around 250 adults with bipolar mania, who, once a day for three weeks, were given either a placebo or the company’s drug, “RAP-219.” Researchers then evaluated participants on several health measures, with the most important being how they fared on a 0 to 60-point clinical scale where higher scores reflect more severe bipolar symptoms. According to Rapport, those on its drug improved an average of 15.4 points by the third week, versus 12.3 points among the placebo group.
    • “That 3.1-point difference was just enough for the results to be statistically significant. Rapport said that, compared to the control arm, drug-treated patients showed improvements across all 11 components of the scale, which evaluates things like mood, speech, irritability and aggression. RAP-219 also beat the placebo on a “secondary” measure that used a different mania severity scale.
    • “The drug was well-tolerated, according to Rapport, with all so-called treatment-emergent adverse events being mild to moderate.” 
  • The New York Times calls attention to “5 Common Medications That Can Mess With Your Sleep.”
    • “Certain prescription and over-the-counter drugs are known to keep people awake. We asked experts for some of the biggest offenders.” * * *
    • “Any sleep disruptions that result from taking a medication should be discussed with a doctor, Dr. Neubauer said.
    • “Adopting healthy sleep habits could also help counter the medication’s side effects, Dr. White added. Try to avoid consuming caffeine after around 2 p.m., don’t drink alcohol just before bed, keep your bedroom dark and cool and maintain a consistent sleep schedule.”

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

  • STAT News reports,
    • “Officials at Dana-Farber Cancer Institute and Beth Israel Lahey Health celebrated on Monday the start of work on their new $1.68 billion Boston hospital to treat cancer patients, the only medical center of its kind in New England.
    • “The clanking of cranes slated to descend over the Longwood site also brings the impending divorce of Dana-Farber and its longtime partner, Brigham and Women’s Hospital, one step closer. Meanwhile, Brigham’s parent, Mass General Brigham, has launched its own rival cancer institute and is constructing new buildings and renovating other spaces to compete.”
  • Fierce Healthcare relates,
    • “Hackensack Meridian Health has signed a definitive agreement to pick up Central New Jersey’s Hunterdon Health, a $230 million deal that would grow the state’s largest health system to 19 total hospitals. 
    • “The pair had signed a letter of intent to merge in June and are now pursuing state and federal regulatory reviews. The announcement did not outline a potential timeline for the merger’s close.
    • “The agreement does outline a $200 million capital investment on behalf of Hackensack Meridian, which the nonprofits said would go toward facilities, programs and Central New Jersey communities Hunterdon serves.” 
  • Beckers Hospital Review tells us,
    • “Tampa, Fla.-based Moffitt Cancer Center recorded operating income of $238.4 million (6.9% operating margin) for fiscal year 2026, up from operating income of $127.5 million (4.2% margin) in fiscal 2025, according to its financial report for the 12 months ended June 30.  
    • “Moffitt reported total revenue of $3.4 billion in fiscal 2026, a 14.3% increase year over year. Patient service revenue rose 14% to $3 billion. Other revenue, which includes state appropriations and grants, increased 14% to $345 million.
    • “Total expenses were $3.2 billion for fiscal 2026, an 11.1% increase year over year. Salaries, wages, benefits and faculty fees totaled $1.5 billion, a 12.7% increase. Supplies rose 8.1% to $1.2 billion. Purchased services increased 21% to $276 million.”
  • and
    • offers a “nonexhaustive” list of “87 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
  • The Wall Street Journal informs us,
    • “Front-line nurses are leaving bedside roles in droves due to burnout, understaffing, verbal abuse and workplace violence.
    • “The annual turnover rate for bedside registered nurses hit 18% last year, according to NSI Nursing Solutions.
    • “Losing a nurse is expensive for hospitals, with research at Emory Healthcare showing it costs the system around $78,000 anytime a nurse leaves.”
  • and
    • “AstraZeneca is partnering with Oracle to use artificial intelligence, cloud and data capabilities to refine clinical research.
    • “The collaboration will initially explore clinical-trial recruitment, earlier diagnosis and drug-safety monitoring.
    • “The first program under the partnership will focus on hypertension care and clinical research in Abu Dhabi.”
  • Beckers Health IT adds,
    • “OpenAI has acquired Orchestra Bio, an AI-powered platform that helps biopharma teams coordinate the drug development process.
    • “OpenAI announced the deal Oct. 20 and did not disclose financial terms. The company plans to combine Orchestra’s team and technology with Rosalind, its suite of AI models and tools for life sciences research, which includes the GPT-Rosalind reasoning model and Rosalind Workbench.
    • “Orchestra Bio’s platform lets scientists and program leaders hand off the monitoring and tracking of studies to AI agents. When a problem hits one part of a drug program, such as a failed manufacturing batch that could delay the start of a clinical trial, the agents identify which activities and timelines are affected, gather relevant information and compare response options. Scientists and program leaders then decide how to proceed.
    • “OpenAI said the combined effort aims to build agents that connect scientific findings to the studies, decisions and next steps needed to advance a potential medicine.”
  • Medical Economics discusses “how unbundled maternity care codes could change OB/GYN pay in 2027.”
  • Per the American Hospital Association News,
    • “The median annual net launch price for new prescription drugs increased 35% from 2022 to 2025, to $257,000, according to a report released by the Institute for Clinical and Economic Review and West Health. Nearly 25% of drugs in 2025 launched above $500,000 and 34% launched between $200,000 and $500,000. The groups found that even if drug characteristics impacting launch prices remain constant, such as product type, therapeutic class, and orphan or ultra-rare status, launch prices may continue to increase.”

Monday report

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

Simplicity is a virtue.

From Washington, D.C.

  • Per a White House news release,
    • “First Lady Melania Trump advanced a landmark program to improve women’s health through a new executive order that strengthens research, prevention, diagnosis, treatment, and care for girls and women throughout every stage of life.
    • “Previous generations fought for women’s rights. Our generation will fight to discover the cures that will ensure a woman can live her life in health and to the fullest,” The First Lady said from the White House.
    • “The Executive Order establishes a White House Women’s Health Task Force and establishes a new Women’s Health Division within the National Institutes of Health to accelerate scientific discoveries to improve women’s health outcomes.” * * *
    • “To learn more about the Executive Order, read the fact sheet released by the White House.”
  • Bloomberg Law reports,
    • “The Trump administration’s move to integrate artificial intelligence agents with Medicare patient data is facing concerns the tech push could put sensitive health information at risk.
    • ‘Since 2025, the Centers for Medicare & Medicaid Services has partnered with more than 700 companies, including Google, Microsoft, and OpenAI, to build its Health Technology Ecosystem, an agency revamp seeking to modernize how Medicare patients use their health data.
    • “Patient and privacy groups, though, warn that without safeguards, the rapid expansion into AI could leave Medicare patients vulnerable to the same pitfalls plaguing the broader health industry.
    • “We are at this incredible inflection point right now, but we really need strong consumer protections to keep pace with all of that innovation,” said Lisa Bercu, senior director of health policy at the National Consumers League.”
  • The American Hospital Association News adds,
    • T”he AHA provided recommendations to the Food and Drug Administration Oct. 19 on potential regulatory frameworks for generative artificial intelligence-enabled medical devices. The AHA expressed support for a flexible, risk-based regulatory framework that protects patients without impeding responsible innovation. Among its suggestions, the AHA recommended the FDA refine the proposed risk heuristic for evaluating the risk of GenAI applications and provide labelling guidance on “informational action directing” devices versus “action taking” devices. The AHA also requested the agency to align premarket clearance and post-deployment evaluation and monitoring activities under a total product lifecycle and clarify that GenAI-enabled clinical decision support and administrative tools are not subject to FDA oversight.” 
  • Beckers Health IT notes,
    • “Somerville, Mass.-based Mass General Brigham researchers built an AI foundation model, trained on more than 40 million face images, that estimates biological age and predicts cancer survival from a single photograph.
    • “The model, called FAHR-Face, powers two tools detailed in a study published Oct. 19 in The Lancet Digital Health. FAHR-FaceAge estimates a patient’s biological age more accurately than prior algorithms. FAHR-FaceSurvival predicts survival outcomes directly from a face photo of a patient with cancer.
    • “The gap between a patient’s FAHR-FaceAge and chronological age was independently linked to survival. The two tools’ predictions were only weakly correlated, and combining them improved survival-model fit in an external validation cohort of cancer patients.
    • “Hugo Aerts, PhD, director of the Artificial Intelligence in Medicine program at Mass General Brigham, said the work is, to the team’s knowledge, “the first demonstration” that an AI model can directly predict cancer survival from a photograph, per an Oct. 19 news release.”

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

  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) has finalized a rule removing the governmentwide time-in-grade restriction for advancement to covered competitive-service General Schedule positions at GS-6 and above. The restriction generally required employees to spend 52 weeks at a lower grade before they could be considered for promotion, even if they met the qualifications for higher-level work.
    • “The old rule made the calendar a gatekeeper. If someone is qualified and ready to take on more responsibility, the government shouldn’t make them wait another year just because the clock says so,” said OPM Director Scott Kupor. “This rule allows agencies to reward demonstrated merit over tenure. Employees still have to meet the standards for the job, and promotions still have to follow merit procedures.”
  • Director Kupor further discusses the significance of this rule change in his Secrets of OPM blog here.
  • FedWeek reports,
    • “OPM has issued a “Government-Wide Recruitment Strategic Plan” for senior agency leaders, HR officials and hiring managers that incorporates many of the administration’s previously announced hiring initiatives while setting a goal that one-third of hires should be “early career.”
    • “Aligned to the Trump administration’s workforce management agenda, Federal agencies should hire patriotic Americans and make hiring decisions based on merit, not proxies. A college degree, or years of tenure, may or may not tell us whether someone is the best fit for a job. Demonstrated skills do,” says the document, attached to a memo to agencies.
    • “Agencies will emphasize lawful, fair, and open competition, grounded in job-related competencies and merit-based skills assessments. Nowhere is this more urgent than in early career recruitment. The federal government is exponentially under-indexed on early career talent,” it says.”
  • and
    • “In its newly released “Governmentwide Recruitment Strategic Plan” (see related story), OPM said it is looking for “disciplined execution by all agencies, not just OPM” which will be looking for “indicators of success” by agencies in carrying it out.
    • “Says a cover memo from OPM director Scott Kupor, “Successful implementation requires unwavering commitment and disciplined execution by every agency, not just OPM. Agency leaders and Chief Human Capital Officers must align recruitment with workforce needs, strengthen early-career talent pipelines in pursuit of the Plan’s hiring goals, measure outcomes, and hold their organizations accountable for results.”
  • FedSmith encourages readers to “Look Beyond Premiums: Understanding the Real Cost of Your [FEHB or PSHB] Health Plan.
    • Learn to choose the best FEHB health plan by weighing premiums, deductibles, copays, and out-of-pocket costs for total yearly expenses.

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

  • Beckers Hospital Review reports,
    • “The FDA has granted accelerated approval to an immunotherapy that may spare some patients with locally advanced rectal cancer from undergoing chemotherapy, radiation and surgery.
    • “The approval covers London-based GSK’s dostarlimab-gxly — sold under the brand name Jemperli — as a standalone treatment for adults with previously untreated stage 2 or 3 locally advanced rectal cancer, according to an Oct. 19 news release from the agency.
    • “Eligible patients’ tumors must be identified by an FDA-authorized test as mismatch repair-deficient or microsatellite instability-high, the release said.” 
  • Reuters relates,
    • “Haemonetics (HAE.N) said on Monday the US Food and Drug Administration ​approved its device designed to seal ‌arterial openings created during minimally invasive heart and vascular procedures.
    • “The device, PerQseal ⁠Elite, uses a fully absorbable ​patch that dissolves over time ​and does not leave a permanent implant in the body.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration has cleared the Twiist automated insulin delivery, or AID, system for use in adults with insulin-treated Type 2 diabetes. 
    • “Sequel Med Tech, which sells the device, disclosed the 510(k) clearance on Friday. The FDA granted the clearance to Deka Research and Development, Sequel’s partner on Twiist.
    • “The FDA cleared Twiist after researchers linked the AID system to reduced blood sugar and increased time in the target glycemic range in a clinical trial.”
  • Cardiovascular Business adds,
    • “Masimo, a California-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its smartSET pulse oximetry platform to identify signs of atrial fibrillation (AFib) and deliver alerts to its Radius Vital Signs Monitor. The newly cleared feature continuously evaluates a patient’s pulse waveform data, flagging clinicians when additional follow-up care may be necessary.
    • “When a patient deteriorates on a general care floor, respiratory compromise and cardiac arrhythmias often develop silently between routine rounds,” Basil Matta, BA, MB, BCh, BAO, Masimo chief medical officer, said in a statement. “By bringing AI-driven pattern recognition directly into the pulse oximetry workflow, smartSET helps clinicians see subtle physiological shifts earlier. It bridges the gap between spot checks, giving care teams actionable insight when minutes count.”
    • “For more than three decades, Masimo has expanded what clinicians can expect from pulse oximetry,” added Tim Benner,Masimo president. “With smartSET, we are bringing intelligent sensing and AI-enabled detection to the bedside—building on our signal-processing expertise to turn continuous monitoring data into meaningful clinical insight.”
  • and
    • “A new size-adjustable pulmonary valve approved by the U.S. Food and Drug Administration (FDA) could reduce the number of open-heart surgeries children with congenital heart disease need as they grow.
    • “Cardiovascular Business spoke to Emile Bacha, MD, chair of the department of surgery and surgeon-in-chief at NewYork-Presbyterian Hospital/Columbia University Medical Center, to learn more. Bacha, a lead investigator in the clinical trial that supported FDA clearance of the Edwards Lifesciences Autus size-adjustable pulmonary valve, said this device addresses the longstanding challenge of valves not being able to grow with pediatric patients into adulthood.
    • “This is indeed an important new advance in the field of treatment of pediatric heart disease,” Bacha, a past president of the American Association for Thoracic Surgery (AATS), explained. “When we replace a valve in a one-year-old they will grow, but the valve is not going to grow. As a consequence, we have to constantly reoperate on this child to upsize the valve. It’s very traumatic for the kids. And those are very big surgeries that involve sternotomy. So it’s not insignificant at all. Instead of having two, three, four or more surgeries, that child will have two, three or four catheterization procedures, which are much, much less invasive.”

From the Medicare Advantage front

  • KFF offers
    • [an explainer that] tackles such subjects as what changes Medicare beneficiaries can make during open enrollment; how Medigap and other forms of supplemental coverage factor into coverage decisions; how Medicare Advantage plans and Part D stand-alone prescription drug plans vary; and the tradeoffs involved when deciding whether to enroll in traditional Medicare versus Medicare Advantage. Get the details.
    • Additional analyses explore how the average Medicare beneficiary will have 28 Medicare Advantage prescription drug (MA_PD) plans available for general enrollment in 2027 (the number of plans varies widely across states), and how Medicare Advantage plan availability varies widely by county in 2027.
    • An analysis of the Part D stand-alone prescription drug plan (PDP) marketshows that there will be a modest reduction in the number of PDPs for 2027, along with modest premium increases less than $10 per month for many enrollees — but much larger monthly premium increases of $50 or more for others if they don’t switch plans.

No Surprises Act News

  • STAT News reports,
    • “Before it won a lucrative government contract, iMPROve Health’s very future was in question.   
    • “The Michigan-based nonprofit lost over $2 million in 2022 alone — over a third of its revenue — on top of losses in previous years. There were budget cuts; it ditched the office, went remote, and even discussed selling the company. 
    • “We had conversations about, ‘Should we merge and be an organization that someone acquires?’ We had those conversations,” said Richard Murdock, a former iMPROve board member.
    • “Three years later, iMPROve boasts a 70% profit margin, almost as high as that of tech giant Nvidia. Its revenue has grown 13-fold. The turnaround is thanks to the company’s new government-backed role: picking winners in high-stakes payment disputes between health care providers and health insurers.
    • “It’s not the only nonprofit making massive sums by acting as an arbitrator in the program, created under a 2020 law to protect patients from unexpected out-of-network bills. Two others, C2C Innovative Solutions and IPRO, are raking in cash as well. For every dollar the three nonprofits made last year, about half was pure profit.” 

From the judicial front,

  • Bloomberg Law reports,
    • “The Trump administration requested the US Supreme Court weigh in on its latest loss over regulation of surprise medical bills, asking whether courts can use the Administrative Procedure Act to universally vacate federal rules.
    • “A ruling in favor of the administration could potentially upend a sprawling web of litigation over federal regulation, including ramifications for lawsuits over rules governing the Affordable Care Act, Medicare, and Medicaid.
    • “The US Court of Appeals for the Fifth Circuit improperly used universal vacatur as a default remedy to overturn provisions of a rule calculating payment benchmarks in arbitration disputes for unexpected out-of-network bills, the administration argued in its petition for certiorari filed Wednesday.”
  • Fierce Healthcare relates,
    • “Healthcare AI startups OpenEvidence and Doximity settled a contentious legal fight over allegations of corporate espionage and cyberattacks, alongside counterclaims of defamation and misinformation.
    • “The two companies reached a settlement in principle on Thursday, leading to a dismissal of all claims and counterclaims with prejudice on Friday, according to court filings in the U.S. District Court in the District of Massachusetts. As part of the dismissal, the judge also ruled that each party would bear its own costs and attorneys’ fees.
    • “Legal representatives for both companies did not respond to requests for comment. The joint notice of settlement did not provide details on the agreement.”
  • Per a Justice Department news release,
    • “Somerset Lifesciences Inc. (Somerset) has agreed to pay $4 million to resolve common law claims for causing Medicare Part D (Medicare) to pay for its prescription-only (Rx-only) generic drug Olopatadine when it was no longer eligible for Medicare coverage. Medicare does not cover drugs that can be purchased by retail customers over-the-counter (OTC) without a prescription. In 2020, the brand name version of Olopatadine switched from Rx-only to OTC, and Somerset was required to change Olopatadine’s label from Rx-only to OTC as well. Instead, Somerset continued to label and sell Olopatadine as Rx-only and caused Medicare to wrongfully pay claims for an OTC drug.” * * *
    • “Except for the admissions contained in the settlement agreement, the claims resolved by the settlement are allegations only and there has been no determination of liability.“

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Regular exercise is an essential piece of the puzzle when trying to prevent or manage cardiovascular disease (CVD), according to a new scientific statement from the American College of Cardiology. The team behind the document recommends prescribing exercise to patients whenever appropriate, explaining even a little bit of movement can make a major impact.
    • “The most important message is that some activity is better than none,” Jonathan N. Myers, PhD, chair of the statement’s writing committee and a health research scientist with the Palo Alto VA Healthcare System, said in a statement. “Patients do not need to become athletes to improve their cardiovascular health. Small increases in physical activity can produce meaningful benefits, particularly for those who are currently inactive.”
    • “Myers et al. emphasized that poor cardiorespiratory fitness is a “powerful and independent predictor” of adverse health outcomes. In fact, the risks of poor cardiorespiratory fitness are comparable to what clinicians see with smoking, hypertension, diabetes and other well-known risk factors. 
    • “To this day, however, cardiologists and other cardiovascular care professionals often meet with patients without prescribing any kind of regular exercise routine.” 
  • The American Medical Association lets us know “what doctors want patients to know about food poisoning.”
    • “Food poisoning can cause vomiting, diarrhea and dehydration. Learn how to spot warning signs, recover safely, prevent illness and when to call your doctor.”
  • MedTech Dive shares the opinions of “5 doctors [who] weigh in on the promise, limitations of Grail’s multicancer test.”
    • “As the closely watched screening test moves closer to Food and Drug Administration approval, MedTech Dive asked cancer experts what encourages and concerns them most about Galleri.”
  • Beckers Hospital Review tells us,
    • “Patients taking GLP-1 medications had lower rates of major cardiovascular complications and infections after surgery than those not taking the drugs, according to a study of more than 2 million adults presented Oct. 18 at the American Society of Anesthesiologists’ Anesthesiology 2026 annual meeting in San Diego.”
  • and
    • “As healthcare leaders celebrate the FDA’s approval of daraxonrasib — a pancreatic cancer drug that nearly doubled survival in clinical trials — two harsh realities remain: most pancreatic cancer patients are still diagnosed at a late stage, and those treated with daraxonrasib will eventually develop resistance to it.
    • “Pancreatic cancer is the third-leading cause of cancer death in the U.S., representing 3.2% of new cancer cases but 8.4% of cancer deaths. Only 14.6% of pancreatic cancers are diagnosed before they spread to other parts of the body, according to SEER data. 
    • “To catch pancreatic cancer before it spreads, researchers are turning to AI.”
  • Healio informs us,
    • “In the years after becoming eligible for biologic therapy, 70% of adults with severe asthma achieved a lower yearly rate of exacerbations with just standard care, according to data published in CHEST.
    • ““In patients with severe asthma and frequent exacerbations, review their blood eosinophil counts from previous years,” Freda Yang, MBChB, MD, honorary clinical senior lecturer at the National Heart and Lung Institute, Imperial College London, and consultant respiratory physician at Royal Brompton Hospital, told Healio.
    • “Persistent eosinophilia suggests continued frequent exacerbations and a likely need for long-term biologics,” Yang said. “Patients without it may improve with standard care or need biologics for a shorter period. As an observational study, these findings need confirming in prospective trials.”
  • STAT News points out,
    • “An oral treatment from Gilead Sciences eliminated the symptoms experienced by patients with a type of inflammatory bowel disease, mid-stage study results reported Monday that could boost the biotech’s push to develop new drugs for inflammatory and autoimmune conditions. 
    • “A 200-milligram daily dose of the Gilead pill, called emvistegrast, taken for 12 weeks resulted in a 23% placebo-adjusted clinical remission rate for patients with moderate to severe ulcerative colitis, the Phase 2 study showed. The statistically significant improvement exceeded Wall Street analyst expectations.
    • “Emvistegrast has the potential to be a best-in-class oral for patients with ulcerative colitis,” Swati Tole, Gilead’s senior vice president overseeing clinical development of its inflammatory disease medicines, told STAT on Friday. “Patients with inflammatory bowel disease, while they have other therapies available, still have persistent symptoms. A majority do not achieve remission, so seeing these data was encouraging for us.” 
  • BioPharma Dive adds,
    • “A rare disease drug previously spurned by the Food and Drug Administration will get another shot at approval after positive Phase 3 results that sent shares of its developer, Disc Medicine, soaring by more than 35%. 
    • “Disc said Monday that the treatment, bitopertin, met all of its main and secondary objectives in a Phase 3 trial in erythropoietic porphyria, an uncommon disease causing hypersensitivity to light. The findings position Disc to resubmit an approval application to the Food and Drug Administration by the end of the year and possibly launch the therapy in 2027.” 

From the healthcare business front,

  • Beckers Hospital Review reports,
    • “Austin, Texas-based Ascension Seton has signed a definitive agreement to acquire a hospital and two urgent care centers in the north Austin area from Cedar Park, Texas-based Family Hospital Systems.  
    • “The deal includes Austin-based Family Hospital at Lake Travis, according to an Oct. 1 news release from Ascension Seton shared with Becker’s. The hospital provides 24/7 emergency care and inpatient care, according to Family Hospital Systems’ website. 
    • “The deal also includes Cedar Park-based Family Medical Center at Lakeline and Family Medical Center at Round Rock (Texas), which offer urgent care, primary care and on-site imaging, according to Family Hospital Systems’ website. 
    • “Ascension Seton, which is part of St. Louis-based Ascension, said the acquisition will give families in Austin’s outer metro area more access to emergency services. The health system said the move supports the market’s growth, patient care and long-term sustainability.”
  • and
    • “UnitedHealth Group’s count of subsidiaries and related entities has reached 2,807, according to the latest “Sunlight Report,” updated in October.
    • “The report comes from the Center for Health & Democracy and is funded by Arnold Ventures. The updated report identified more entities since the findings published in July 2025, factoring in 2024 year-end and 2025 Schedule Y state insurance filings, publicly confirmed 2026 transactions and U.S. Securities and Exchange Commission filings through the second quarter of 2026.” * * *
    • “UnitedHealth’s acquisitions have slowed since the original report’s data window. From early 2024 to the end of 2025, 368 entities joined and 268 left. The report documented two acquisitions in 2026: benefits administration platform Alegeus Technologies and six surgery centers through a Federal Trade Commission order.” 
  • Beckers Clinical Leadership relates,
    • “Nurse scientists are calling on hospitals, payers and credentialing bodies to overhaul how they measure nursing care, arguing that today’s metrics capture only a sliver of what nurses actually do.
    • “In a viewpoint published Oct. 19 in JAMA Internal Medicine, three nurse researchers — led by Lori Kennedy, PhD, RN, director of the Center for Nursing Science at Sacramento, Calif.-based UC Davis Health — proposed a set of nurse-sensitive outcome measures spanning nine domains of acute and critical care nursing practice, along with a framework to develop them.
    • “Their central critique: the nurse-sensitive metrics CMS relies on focus almost entirely on patient harm, including hospital-acquired infections, falls, pressure injuries and restraint use. Those measures matter, the authors wrote, but they “measure nursing by its absence.”
    • “When nursing value is expressed only as harm incurred, the economic case for nursing investment becomes purely defensive,” they wrote. Institutions tally the cost of each central line-associated bloodstream infection, they noted, but not the value of a nurse catching signs of sepsis before a patient becomes hypotensive and requires an ICU transfer.” * * *
    • “The proposed framework builds on the 2024 “Blueprint for Change in Acute and Critical Care Nursing,” a call to action from a national panel of nursing science leaders that included Dr. Kennedy.”
  • Beckers ASC Review tells us,
    • “Chicago-based Northwestern Medicine has opened a new outpatient center on the Northwestern Medicine Huntley (Ill.) Hospital campus. 
    • “The 80,000-square-foot facility will provide services including general surgery, cardiovascular, gastroenterology and pulmonary medicine, according to an Oct. 19 news release from Northwestern Medicine. 
    • “The expansion will add about 300 new jobs over the next three years.” 
  • Beckers Payer Issues informs us,
    • “Cigna Healthcare in the first quarter of 2027 will roll out Health Sense, a tailored customer and clinical support model that brings together health, benefits and cost information. 
    • “While the model will initially roll out for customers with oncology and cardiometabolic needs, Stanley Crittenden, MD, chief medical officer at Cigna Healthcare, told Becker’s that the team is just getting started.
    • “Don’t look at this as just a one-time product launch, but think about this as a more iterative process where we’re going to be adding more conditions,” he said.
    • “Cigna chose to roll out Health Sense to those with oncology and cardiometabolic conditions first because they often have complex and costly care journeys, Dr. Crittenden said. He did not share which conditions could be on the horizon next, but he said the team is considering other areas where patients have “the greatest needs and the highest complexity that would benefit from earlier intervention.” Dr. Crittenden said Cigna is currently focused on learning from the initial rollout and validating outcomes.”
  • and
    • “CVS Health named Maria Wilson, MD, as chief medical officer of Oak Street Health, the company’s value-based primary care centers for older adults. 
    • “Dr. Wilson has been with Oak Street Health since 2017, most recently serving as an executive medical director, according to her LinkedIn profile. 
    • “It’s a privilege to take on this role in a place where I’ve seen firsthand what our providers and care teams can do,” Dr. Wilson said in an Oct. 16 LinkedIn post. “Value-based care is about getting the right care to patients at the right time while supporting the provider care teams who deliver it, and I’m excited to help lead that work.”
  • The New York Time points out “professionals [who] may be the best kept secret in elder care.
    • “They can arrange a move to a senior living facility, deal with Medicare and Medicaid, recommend doctors, drive a client to the dentist, and much more.”
  • NBC News notes, “Many Women Are Still Struggling to Fill Estrogen Patch Prescriptions. What to Do If You Can’t Get Yours
    • “As demand for menopause treatment increases, estrogen patches are hard to find at pharmacies. Here’s what to do if you can’t refill your prescription.”
  • Per the Wall Street Journal,
    • “Roche Holding entered a licensing agreement with Hansoh Pharmaceutical Group that could net the Chinese drugmaker more than $15 billion.
    • “Hansoh will receive $400 million upfront and $110 million after a year, plus potential payments subject to targets and royalties on sales.
    • “The collaboration aims to advance a portfolio of antibody-drug conjugates, which are targeted cancer therapies, across multiple cancer types.”
  • and
    • “Germany’s Merck KGaA agreed to buy U.K. biotech company Silence Therapeutics for $1.3 billion.
    • “Merck is offering $20 in cash for each American depositary share of Silence Therapeutics, more than double its Friday closing price.
    • “The deal aims to strengthen Merck’s rare-disease pipeline by adding divesiran, an experimental drug ready for late-stage clinical trials.”

Cybersecurity Saturday

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

From the frontier AI front,

  • Beckers Health IT reports,
    • “OpenAI said one of its internal AI models broke through security on a government statistics website to get hospital-bed data the site had refused to give it.
    • “The model was in reinforcement learning training at the time, according to a misalignment report the company updated Oct. 15.
    • “The incident happened June 17, and OpenAI discovered it Aug. 13. The model’s task was to find a district’s historical hospital-bed totals on the site. OpenAI did not name the website or the country.
    • “After the site denied it access several times, the model used the site’s file-download feature to pull application and configuration files from outside the folder that feature was meant to serve. “Those files contained a database connection string, a secret used to sign authorization tokens and email login credentials.
    • “The model then found that the site’s code read identity data from authorization tokens without checking their signatures. It built unsigned tokens, got past the statistics endpoint’s authorization checks and saved 24 years of data, far more than the single year it had been asked for.”
  • Bleeping Computer lets us know,
    • “Anthropic is warning that small AI models could soon be able to self-replicate across consumer IoT devices, from Android TV boxes to smart ovens, creating distributed botnets capable of running AI workloads without relying on data centers.
    • “The company’s experiments showed that models could identify unfamiliar devices, connect them into a network, and prepare them to run an AI model.
    • “Although the researchers successfully distributed the Gemma4-26B-A4B model from Google DeepMind on 15 off-brand Android TV boxes, they did not demonstrate a fully autonomous, self-replicating AI worm running on real IoT hardware.
    • “However, they estimate that smaller models could achieve self-replication by the end of the year if they continue to improve at their historical rate.
    • “Our experiments suggest that small AI models may be months away from being capable enough to self-replicate on commercial internet-of-things (IoT) devices, like smart ovens and off-brand Android TV boxes,” Anthropic warns.”
  • Cyberscoop adds,
    • “The federal government is advising AI companies to set more industry standards for securing agents in sandbox testing environments.
    • “In joint guidance from the Cybersecurity and Infrastructure Security Agency, the National Security Agency and the Center for Advancing Innovation and Standards for Super Intelligence (CAISSI) at the Department of Commerce, AI companies are encouraged to lean more heavily on cybersecurity technical controls, independent testing and evaluation of new models and develop “shut down policies” that govern when a model or test should be taken offline.
    • “The guidance comes after a summer when OpenAI, Anthropic, Google, Meta and other companies say their AI models escaped from testing environments and hacked real organizations and websites. The problem has bedeviled frontier AI companies, with many of their own researchers saying it’s possible that hundreds – even thousands – of similar sandbox escapes may have occurred over the summer, raising major questions about the lack of effective monitoring in place.
    • “While these incidents highlight the importance of traditional cybersecurity principles and practices, they also introduce novel considerations for incident prevention, response, and reporting,” the agencies wrote. “These novel considerations primarily stem from the agentic nature and advanced cyber capabilities of cutting-edge SI systems.”
  • Federal News Network notes,
    • “Artificial intelligence is accelerating cybersecurity threats, while AI adoption is posing urgent risks around data, identity, trust and operational decision-making. Agencies grappling with those challenges are exploring how to securely adopt AI for both general purpose use and cyber defense.
    • “Thomas Edgar, the chief cybersecurity scientist at Pacific Northwest National Laboratory, said PNNL’s research explores both the risks and opportunities posed by advanced AI models.
    • “Trying to benchmark and understand how bad these models could be if they’re used to target our critical infrastructure,” Edgar said during AI driven defense and the future of the SOC discussion. “But we do prototypes and proof of principle type research, and so AI has been a boon for us to help us kind of iterate and try things faster, supporting our reverse engineering, vulnerability analysis, protocol analysis, data analysis. We’re really looking at how we can really extract optimization out of AI to make us more efficient and effective, and then ultimately transition that off to our government sponsors and our critical infrastructure, so that they can take advantage of what we’ve learned.”

From the cybersecurity policy and law enforcement front

  • Cyberscoop reports,
    • “Members of Congress are pressing the Trump administration to expand the federal government’s role in securing artificial intelligence, wanting new safety standards and regulations, independent testing of models and more “aggressive” use of AI for defensive cybersecurity purposes.
    • “In a letter, Sens. Maria Cantwell, D-Wash., and Mike Rounds, R-S.D., said that multiple incidents of frontier AI models escaping sandbox protections and breaching real companies, organizations and governments necessitate a stronger federal role in regulating the technology.”
  • Security Boulevard informs us,
    • “The FBI has arrested Canadian cybersecurity expert Edward Dubrovsky, accusing him of conspiring with ShinyHunters in the breach of the agency’s systems.
    • “The attack exposed sensitive information of thousands of FBI employees, including job details, specializations, and medical records, after hackers exploited an unpatched Oracle PeopleSoft vulnerability.
    • “Dubrovsky’s arrest follows the detention of other alleged ShinyHunters associates as investigators pursue the prolific extortion group, which the FBI says has breached more than 140 organizations since 2025 and extorted $70 million.”
  • The American Hospital Association News tells us,
    • “Microsoft and Health-ISAC Oct. 15 announced that they disrupted three cybercriminal businesses that provided services to threat actors to attack more than 75,000 organizations worldwide, including healthcare. The businesses were found to be part of a wider, Chinese-language cybercriminal marketplace supplying malicious services to threat actors around the world. Investigators that included Microsoft, Health-ISAC, Japan’s National Police Agency and other organizations collaborated to seize and redirect domains for infrastructure operating the three criminal businesses — YAM Store, CoGUI and Iron Man. The businesses collectively enabled more than 1 billion malicious messages that targeted consumers, healthcare organizations, financial institutions and other entities in more than 150 countries, generating tens of millions of dollars.” 
  • Bleeping Computer adds,
    • “The U.S. Department of Justice (DoJ) has disrupted the Famous Chollima threat group’s operations by arresting two suspects, charging 14 individuals, and seizing nearly 187 laptops used in North Korean [(DPRK)] remote IT worker schemes.
    • “Famous Chollima (a.k.a. WageMole) is commonly tracked as a DPRK threat actor associated with fraudulent IT-worker schemes that generate revenue for the DPRK regime.” * * *
    • “Laptop farms are locations where facilitators host employer-issued computers that North Korean IT workers access remotely to appear based in the United States.
    • Law enforcement agents seized approximately 187 laptops and KVM input devices, which were used by Famous Chollima operatives that cybersecurity company CrowdStrike had been tracking since April 2025.
    • “CrowdStrike researchers say that DPRK IT workers used several methods to send the company-issued laptops to the “farm,” instead of the address in the provided identity documents: 
      • Submit fake theft reports to trigger replacement shipments to the farm’s address
      • Rotate through residential addresses to obscure the final destination
      • Claim last-minute relocations to divert devices mid-shipment
      • Abuse IT staffing roles they sometimes hold to covertly redirect shipments
    • “CrowdStrike says public exposure has pressured the operatives, leading them to rely more on spoofing device identifiers or even reusing identifiers across victim organizations.
    • “While CrowdStrike acknowledges that actions like Lonestar Roundup will likely have limited impact, the company called the operation “the beginning of a broader U.S. law enforcement effort to dismantle Famous Chollima’s U.S. infrastructure.”

From the cybersecurity breaches and vulnerabilities front

  • HIPAA Journal reports,
    • “In July 2026, 77 healthcare data breaches affecting 500 or more individuals were reported to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights. July was the third consecutive month in which large healthcare data breaches increased, with a month-over-month increase of 10%.” * * *
    • “A majority of the data breaches reported in July were due to hacking and other IT-related incidents, including all but one of the 23 data breaches affecting 10,000 or more individuals. In July, 67 of the month’s data breaches (87%) were reported as hacking/IT-related incidents, involving the protected health information of 33,446,371 of the month’s affected individuals (99.9%). The average breach size was 499,200 individuals, and the median breach size was 4,851 individuals.” * * *
    • “In July, network servers were the most common location of breached protected health information, followed by email systems.”
  • and
    • “Cyberattacks on healthcare organizations are continuing to rise, are becoming costlier to resolve, and are increasingly negatively impacting patient care, according to a recent survey conducted on behalf of the cybersecurity firm Proofpoint. The findings were published in the 2026 Ponemon Healthcare Cybersecurity Report.
    • “The survey was conducted by the Ponemon Institute and included 705 responses from IT and IT security practitioners whose responsibilities include setting cybersecurity policies, selecting vendors and contractors, and managing security budgets. The respondents included public healthcare providers (22%), private healthcare providers (18%), healthcare insurers (18%), payers (11%), healthcare insurance companies (10%), with the remainder from life sciences, pharma, and biotechnology companies.” * * *
    • “While hacking incidents continue to increase, insider risk continues to be a problem in healthcare, with 97% of organizations experiencing at least two data loss or exfiltration incidents in the past 12 months, with an average of 21 incidents at each organization. More than half of respondents (54%) said these incidents impacted patient care, and 56% of respondents said these insider incidents resulted in an increase in mortality rates.
    • “Cybersecurity incidents are increasingly disrupting clinical operations, consuming organizational resources, and affecting care delivery,” explained Proofpoint.  “The healthcare organizations that will be most successful in the years ahead will be those that combine cyber resilience, identity security, human risk management, supply chain security, and AI governance into a unified strategy focused on protecting both operations and patient outcomes.”
  • Cybersecurity Dive relates,
    • “Days after a cyberattack targeting French supermarket refrigerators, thousands of controllers across the globe are visible online and at risk of compromise. 
    • “Hundreds of grocery stores in France were targeted in a sophisticated attack, in which hackers gained access to programmable controllers that regulate commercial refrigeration systems. 
    • ‘Hackers were able to manipulate controls inside the refrigerators, causing systems to overheat – and in some cases catch fire – leading to millions of dollars in damage. 
    • Hackers targeted vulnerabilities in Danfoss AK-SM, Danfoss AK-SC, Copeland xweb and Dixell xweb controllers, according to ANSSI, France’s national cybersecurity agency.” * * *
    • Security researchers say the problems begin in the design of these systems, where security is not a top priority. 
    • “People who design systems, people who build systems, they usually believe that people will be well behaved,” Aleksandr Yampolskiy, co-founder and CEO of Security Scorecard, told Cybersecurity Dive. “But hackers are not well behaved.”
    • “High-severity vulnerabilities in Danfoss controllers were publicly disclosed in an August report by Claroty, a firm that specializes in industrial cybersecurity. Researchers found high-severity flaws in the web management interface of Danfoss systems that could allow an attacker to take control of a device.
    • “The vulnerabilities were tracked as CVE-2025-41451 and CVE-2025-41452. Researchers originally alerted Danfoss to the flaws in 2025 before releasing the report under a coordinated disclosure process. The manufacturer patched the flaws and issued additional guidance. 
    • “The attacks impacted hundreds of supermarkets across multiple chains, including Carrefour, Monoprix, Cooperative U and Intermarche. 
    • “A spokesperson for Copeland confirmed that a vulnerability was found in discontinued end-of-life controllers. The company is actively working with impacted customers to mitigate the risk.”
  • CISA added nine known exploited vulnerabilites to its catalog this week.
    • October 13, 2026
      • CVE-2026-96951 Microsoft Windows Command Injection Vulnerability
      • CVE-2026-104935 Ivanti Connect Secure Authentication Bypass by Spoofing Vulnerability
        • CISA separately advises about the Ivanti KVE here.
        • SOC Prime discusses the Microsoft Windows KVE here.
    • October 14, 2026
      • CVE-2026-0322 Palo Alto Networks PAN-OS Code Injection Vulnerability 
      • CVE-2026-76519 Cisco Secure Email Gateway Relative Path Traversal Vulnerability
      • CVE-2026-105133 Ahsay AhsayCBS Improper Authentication Vulnerability 
      • CVE-2026-105134 Ahsay AhsayCBS Command Injection Vulnerability 
        • The Hacker News discusses the Palo Alto Networks KVE here.
        • SOC Prime discusssed the Cisco KVE here.
        • The Hacker News discusses the Ahsay KVEs here.
    • October 15, 2026
      • CVE-2026-21589 Atlassian Multiple Products Files or Directories Accessible to External Parties Vulnerability 
        • TechNadu discusses the Atlassian KVE here.
    • October 16, 2026
      • CVE-2025-61624. Fortinet Multiple Products Path Traversal Vulnerability
      • CVE-2026-102764 BeyondTrust Remote Support Authentication Bypass by Spoofing Vulnerability 
        • Cybersecurity Dive discusses the Beyond Trust KVE here.
        • CISA also gives separate advice on the Beyond Trust KVE here.
        • The Hacker News discusses the Fortinet KVE here.
  • SC Media lets us know,
    • “We had a lot of predictions in place at the start of 2026, most of which have come to fruition. But in several cases, reality moved even faster than we expected.
    • “The biggest change we have seen so far in 2026 was not a single new attack technique. It’s the way several trends have come together. AI now helps attackers move much faster than before, identities are becoming more important than malware, and legitimate tools and trusted platforms are increasingly becoming the attack path themselves.”

From the ransomware front

  • Beckers Health IT reports,
    • Ransomware attacks and unverified ransomware claims targeting U.S. healthcare organizations increased 64% in the third quarter of 2026 from the second quarter, an Oct. 15 report from cybersecurity research company Comparitech found. * * *
    • The U.S. accounted for 185 of the 306 healthcare ransomware incidents and claims tracked worldwide between July and September. Of those U.S. incidents, 26 were confirmed, including 23 involving healthcare providers.
    • Healthcare technology companies experienced the largest quarter-over-quarter increase among the healthcare business categories highlighted in the report. Comparitech identified 22 incidents and claims targeting those companies, up 175% from eight in the previous quarter. Medical manufacturers accounted for another 51 incidents and claims, a 28% increase from the second quarter.
    • “Saber Healthcare Group had the largest reported ransomware-related breach, affecting 427,084 people. The organization confirmed in July that a cyberattack had encrypted some files and disrupted services. In September, it began notifying individuals of a breach involving medical information, health insurance details and Social Security numbers. Other large breaches identified in the report involved Park Place Behavioral Healthcare, affecting 71,702 people; Hawaii Family Dental, affecting 45,853; WindRose Health Network, affecting 33,158; and Vernon & Waldrep OB-Gyn Associates, affecting 17,435.
    • “The median reported ransom demand was $300,000 for healthcare providers and $150,000 for healthcare businesses. No ransom payments were officially confirmed during the reporting period.
    • “The Gentlemen made the most claims against healthcare providers, with 18, followed by INC with 14. Qilin led claims against healthcare businesses with 15. Chaos had the most confirmed attacks in each category.”
  • The HIPAA Journal adds,
    • “The tactics of ransomware groups are constantly changing to increase pressure on victims to give in to their demands. Initially, file encryption alone was sufficient; however, as victims improved cyber resilience and were able to recover their encrypted files from backups, tactics had to evolve. Ransomware groups incorporated data theft into their attacks and started threatening to sell or leak the stolen data if the ransom was paid. This double extortion approach proved highly successful, with the threat of a data leak alone sufficient to prompt many victims to pay up.
    • “Encryption and data leak threats are no longer enough, as the percentage of victims paying ransoms continues to fall. According to a recent survey commissioned by the Identity Threat Detection and Response (ITDR) firm Semperis, the percentage of ransomware victims paying ransoms has fallen from 78% in 2024 to 69% in 2025, and 59% in 2026.
    • “Ransomware groups have responded by adopting more aggressive tactics, and a trend has emerged of ransomware groups issuing personal threats against company employees and their friends and family members. The survey revealed that 37% of ransomware attacks involved threats against friends or family members of staff members, and 41% of respondents to the survey said they had been a target of physical or psychological intimidation.
    • “While contacting individuals whose data was stolen in an attack has been adopted by several groups in the past, the threats have generally been limited to the publication of personal data, but threats are becoming more severe. Ransomware groups are now issuing threats of physical violence and are contacting employees and their friends and family members via text, email, or phone, confirming that they know where they live, work, and even where their children go to school.” * * *
    • “I’ve spoken with CISOs that had strong relationships with law enforcement,” said Courtney Guss, AVP of Crisis Management, Semperis. “They’ve found it to be a much faster route to information and resources than they would otherwise have found on their own, which can often help them recover more quickly. So, knowing those contacts and building those relationships in advance should be part of your crisis management plan.” Semperis also recommends strengthening identity resilience, preparing for identity system breaches, and practicing incident response procedures time and again against realistic scenarios, including tabletop exercises involving all team members involved in the ransomware response.”
  • BitSight offers a “DragonForce Ransomware Profile: From Affiliate Program to Cybercrime Cartel”

From the cybersecurity business and defenses front

  • The Wall Street Journal reports,
    • “Proofpoint has agreed to acquire data-security company Varonis Systems for about $6.3 billion, as artificial-intelligence security continues to drive deals and investment across the cybersecurity industry.
    • “Proofpoint will pay $49.75 a share in cash for Varonis, a 52% premium over the stock’s June 22 closing price, the final trading day before reports of a potential sale first surfaced. The transaction is expected to close in the first half of 2027, subject to approval from Varonis shareholders and regulatory bodies.
    • “The acquisition comes as cybersecurity vendors scramble to expand their AI capabilities, both to defend against threats that use the technology and to safeguard corporate systems increasingly accessed by autonomous AI tools.
    • “Varonis specializes in securing sensitive corporate data and managing access controls, while Proofpoint primarily focuses on email protection and user-level threat defense.”
  •  and
    • “Quantum-computing company IonQ IONQ struck an all-stock deal to buy Elisity in a transaction that values the cybersecurity firm at up to $1.3 billion, executives told The Wall Street Journal. 
    • It is a bet that cybersecurity will be even more critical for companies as quantum computing and AI systems become more powerful and advanced, said IonQ Chairman and Chief Executive Niccolo de Masi. 
    • “The bad guys are going to keep taking advantage of new technology,” he said in an interview. “Unfortunately, we are entering the most dangerous years, vis-à-vis cybersecurity risks.” * * *
    • “Founded in 2019, Elisity offers a platform that aims to prevent cyber attackers or ransomware from spreading across organizations. Some of its big customers include healthcare companies and hospitals.” * * *
    • “IonQ, which works closely with the U.S. Defense Department, has been on an acquisition spree to become a one-stop shop for its customers. Earlier this year, it struck its biggest deal yet, a $1.8 billion takeover of chip maker SkyWater Technology.”
  • Cybersecurity Dive relates,
    • “The open-source software community needs to understand several key lessons in order to improve its cybersecurity posture, according to IBM, which operates a clearinghouse for analyzing and disclosing open-source vulnerabilities.
    • “Finding a vulnerability is only the start,” IBM said in a report published on Thursday [October 15]. “Security teams must understand the risk, determine whether action is needed, find a usable fix, then get that fix to the software that needs it.”
    • “The new report — the first in a series collecting insights from IBM’s clearinghouse — is meant to help software maintainers and their customers, including businesses, better understand systemic risks in the open-source ecosystem.”
  • and
    • “Hackers could break into businesses by going after internet-exposed AI tools that often contain serious vulnerabilities, the internet monitoring firm Censys warned in a report published on Wednesday [October 14].
    • “The growing complexity of the AI ecosystem — in which public-facing services rely on a sprawling web of back-end products, many of them neglected by security teams — creates additional security risks, researchers said.
    • The Censys report also analyzed internet exposures of industrial control systems (ICS), finding that many of them ran traditional IT services that made them more hackable.
  • A human pentester considers when how AI pentesting stacks up against human pentesting.
    • “AI pentesting and human pentesting are different, and once you stop trying to rank them the comparison gets a lot more useful.
    • “The agents are finding serious issues in applications that human testers have already been through multiple times. They’ll read a whole codebase, work through every path in it, and write up every instance of what they find with the fix down to the line of code.
    • “And you can run one whenever you want. For what a single human engagement costs you can run four AI pentests, which means you can do deep testing on a regular basis rather than once a year.
    • “That’s a key thing that is missed by human pentesting, and often applications have undergone a lot of untested changes in between pentests.”
  • Per the Cybersecurity Hub Newsletter,
    • “Anthropic has launched OSS Scanner, a free service that uses its most capable AI models to search open-source software for security vulnerabilities, expanding its efforts to help developers identify weaknesses before attackers exploit them.
    • “The service offers participating projects periodic security scans. Its launch introduces a faster route for distributing findings to maintainers who want early access to potential vulnerabilities.
    • “The central trade-off is human review. Reports from the new service are generated and delivered without prior human triage, leaving participating projects to establish whether a reported issue is valid and warrants a fix. That could accelerate remediation for teams with sufficient expertise, but it also raises questions about how much additional assessment work maintainers can absorb.”
  • Here’s a link to Dark Reading’s CISO Corner.

Thursday report

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

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • “The Department of Justice has a warning for health care executives: Don’t be another Theranos. 
    • “As the Trump administration continues its fight against Medicare and Medicaid fraud, it is also expanding its investigations into corporate wrongdoing, DOJ officials announced this month.”
    • “A key part of that plan is making it easier for companies themselves to report potential criminal activity, and encouraging whistleblowing, Jacob Foster, deputy assistant attorney general in the National Fraud Enforcement division, said Thursday at the STAT Summit in Boston. Foster oversees the unit that investigates health care fraud.” * * *
    • “Going forward, companies in the health care sector looking to file voluntary self-disclosures will find a one-stop shop at the DOJ, Foster said. They previously would’ve had to navigate a separate process at the Department of Health and Human Services, but that is now being consolidated under the health care fraud section at the DOJ. 
    • “Under the new policy, companies that report potential criminal misconduct can reap the benefits — such as a limited cap on financial damages — from both agencies at once. 
    • :The health care fraud section at the DOJ brings a range of expertise under one roof to handle issues like the emerging field of digital health technology, Foster said. DOJ will make use of data analytics and artificial intelligence algorithms to try and suss out instances of corporate wrongdoing, like providers billing for unneeded services, companies fabricating patient records, or health tech companies adding redundant diagnoses. 
    • “The department will also design new programs that “appropriately incentivize” whistleblowers to report fraud, according to an Oct. 1 memo from Assistant Attorney General Colin M. McDonald. Health care investigators also look at social media, news reports, and other sources of information to learn about companies possibly breaking the law, Foster said.” 
       
  • This new Justice Department policy “making it easier for companies themselves to report potential criminal activity, and encouraging whistleblowing” is available here.
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention issued a reminder Oct. 14 that the declaration supporting the emergency use of COVID-19 in vitro diagnostics tests will end Dec. 26. The December end date marks the end of a 180-day transition period from the end of the COVID-19 emergency use authorization declarations announced June 30. The EUA declarations were issued in 2020 to accelerate access to medical products during the COVID-19 pandemic.”

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

  • Federal News Network reports,
    • “The Office of Personnel Management and the White House Task Force to Eliminate Fraud are partnering to hire the next cohort of the US Tech Force. The two-year program will place applicants across agencies, including the General Services Administration, the Social Security Administration, the Office of Personnel Management, the Department of Health and Human Services, the State and Treasury departments. Vice President JD Vance says the partnership will help the government identify fraud, waste and abuse and reduce reliance on foreign technological advancements. Tech Force positions are open to the public and federal employees through career transition and reinstatement programs. The job announcement closes October 23.”
  • FedSmith offers an approach that allows federal and postal employees and annuitants to compare health coverage without getting overwhelmed.
  • Tammy Flanagan, writing in Govexec, explains that “Federal retirees face more than a COLA change in 2027.”
    • “From Medicare premiums and Social Security earnings limits to a federal pay freeze, several changes could affect retirees’ finances and the benefits available to them next year.”

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

  • The AP reports,
    • “For the first time in more than a quarter-century, Americans have a new option when shopping for sunscreen: a skin-protecting chemical that’s long been a go-to option in Europe and other parts of the world.
    • “The U.S. Food and Drug Administration approved bemotrizinol — sometimes called BEMT — in June. The first sunscreens containing it are now hitting U.S. store shelves, including formulas from Neutrogena and other manufacturers.
    • “Dermatologists say the chemical fills an important market gap by offering broad protection, like the most well-established sunscreen ingredients, but without their cosmetic downsides, including white streaking.”
  • Fierce Pharma tells us,
    • “U.S.-based generic drugmaker Par Health has issued a voluntary recall of 22 lots of the direct thrombin inhibitor argatroban for IV injection that could be contaminated with cellulose, polystyrene, polyethylene terephthalate, stopper material, and potentially even stainless steel.
    • “The recall, which was published to the FDA’s website on Oct. 14th, is Par’s third in a matter of weeks.”
  • Targeted Oncology relates,
    • “The FDA will review FYB206, an investigational biosimilar candidate referencing pembrolizumab (Keytruda), after accepting its biologics license application (BLA), marking the first publicly announced acceptance of a filing for a pembrolizumab biosimilar, according to a news release from Zydus Lifesciences and Formycon.1
    • “The application was sent to the FDA in the third quarter of 2026. The Biosimilar User Fee Amendments (BsUFA) set a 12-month goal from submission to completed review, made up of a filing review lasting as long as 60 days followed by a 10-month substantive review. On that schedule, a regulatory decision could come in the third quarter of 2027, and a regulatory dossier has also been filed with Health Canada, according to the companies.”

From the Medicare Advantage front,

  • Beckers Hospital Review reports,
    • “Kaiser Permanente led the 2027 U.S. News & World Report ratings for the “best overall” Medicare Advantage companies.
    • “The ratings, published Oct. 14, are based on a five-point scale, assigning weights to more than 30 CMS quality measures. After calculating contract ratings, U.S. News determined enrollment-adjusted average ratings for carriers. U.S. News considered MA companies among the “best” if they had an overall rating of at least 3.8 once rounded and served at least 1,000 beneficiaries in December 2025 in each of 10 or more states or territories where they still offer 2027 coverage.
    • “These ratings looked at standalone MA contracts, as well as ones that also cover Part D. For the publication’s Medicare Part D ratings, the same two companies secured the “best overall” recognition in 2026 and 2027. In 2027, Humana scored 3.8, and Centene scored 3.5. To qualify as a top Part D company, insurers needed to have served at least 1,000 Part D beneficiaries in each of at least 10 jurisdictions where they still offer coverage for 2027. The threshold was an enrollment-weighted average rating of at least 3.5 after rounding.”

From the Affordable Care Act marketplace front,

  • Beckers Payer Issues relates,
    • “CMS has reinstated a small number of enrollees who lost coverage after the agency canceled ACA policies for more than 760,000 people, according to a KFF Health News report published Oct. 15 in NPR.
    • “KFF Health News learned of the reinstatements through insurance industry sources, finding that not all of those who lost coverage were fraudulently enrolled. 
    • “On Aug. 31, CMS canceled 315,000 policies for 2026 that covered more than 760,000 individuals. These enrollees signed up with agent or broker assistance but lacked citizenship or immigration documentation, and issuers were unable to find claims or did not have records of contact, according to a September rulemaking document. CMS told Becker’s on Oct. 15 that another criterion was whether premiums were fully covered by advance payments of the premium tax credit. CMS expected that these cuts would lead to a return of roughly $2.2 billion in subsidies.”

No Surprises Act News

  • Beckers Payer Issues relates,
    • “Arbitration awards under the No Surprises Act can reach nearly 6% of total commercial medical spend in some regions, UnitedHealthcare CEO Tim Noel said during an Oct. 13 earnings call. 
    • “The medical cost trend for UnitedHealthcare’s commercial business is “exceeding” an initial expectation of 11%, Mr. Noel said. While Mr. Noel pointed to clinician cost intensity and expensive specialty drugs as part of that, he also said there has been “an acceleration of costs related to the No Surprises Act.” He cited “ongoing abuse” driven by “a relatively small number of clinician groups and third-party organizations.”
    • “Mr. Noel said this translates to billions of dollars in additional costs that hit consumers and employers.” 

From the judicial front,

  • Per a Justice Department news release,
    • “A Kansas CEO and owner of an internet platform was sentenced yesterday to 19 years in prison for his role in operating a platform that generated false doctors’ orders and prescriptions to defraud Medicare and other federal health care benefit programs out of more than $1 billion.
    • “The Department of Justice and our agency partners dismantled one of the largest telemedicine fraud schemes ever, and yesterday’s lengthy prison sentence holds the orchestrator of that scheme accountable,” said Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division. “The defendant’s fraud scheme lured hundreds of thousands of elderly and disabled Americans into a sophisticated international telemarketing system with one goal: stealing as much as possible from the Medicare trust fund. The Fraud Division will continue to leverage its resources to take down complex fraud operations like Blackman’s DMERx.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Pediatric infectious disease specialists in Pennsylvania, home to the nation’s largest measles outbreak in more than three decades, are treating an influx of children with severe complications from a virus many physicians have little experience with, NBC News reported Oct. 14.
    • “Patrick Gavigan, MD, a pediatric infectious disease physician at Penn State Health Golisano Children’s Hospital in Hershey, said he expected measles to behave like COVID-19 in children, mainly manifesting as respiratory illness and hitting those with underlying conditions hardest. Instead, the virus is causing serious complications beyond the lungs in many previously healthy children, including in the gut, liver and brain, according to the report.
    • For example, some children are developing encephalitis, or brain inflammation, in response to the virus, according to Dr. Gavigan.
    • “They go from walking and talking one day to the next having significant neurologic dysfunction,” he told NBC News. Dr. Gavigan added that these patients recover slowly and often aren’t back to normal by the time they leave the hospital.”
  • and
    • “New dementia cases worldwide are projected to more than double by 2050, from an estimated 11.4 million in 2023 to 24.7 million, according to a meta-analysis published Oct. 12 in JAMA Neurology.
    • “Researchers led by the University of New South Wales in Sydney analyzed participant-level data from 22 population-based cohorts. The cohorts included 38,418 adults aged 60 and older without dementia at baseline, across 18 countries and territories on six continents. Approximately 3,001 participants developed dementia as of 2021. 
    • “The projection assumes age- and sex-specific dementia rates stay constant. That means the growth reflects an aging global population, not an increase in individual risk.”
  • MedScape relates,
    • “The combination of a low-calorie diet with a supervised exercise regimen induced nonpharmacologic remission of early-onset type 2 diabetes (T2D) in more than half of participants in a new study, with low drop-out rates and preservation of lean mass.
    • “The take-home message is that in early-onset type 2 diabetes, people should ideally have a potent nondrug option to tackle [the disease],” first author Kaberi Dasgupta, MD, a professor of medicine and director of the Division of General Internal Medicine at McGill University in Montréal, Quebec, Canada, told Medscape Medical News.
    • “In addition to inducing diabetes remission, the diet/supervised exercise intervention “shifts weight loss where we want it to be — from the fat compartment — and also increased muscle health, strength, and fitness, improving mood, lowering distress related to diabetes, and enhancing quality of life,” she said.”
  • MedPage Today tells us,
    • “Continuous glucose monitors (CGMs) are recommended for patients with type 1 diabetes and insulin-treated type 2 diabetes, but evidence has been limited in those with non-insulin-treated type 2 diabetes.
    • “Compared with routine care, adults with non-insulin-treated type 2 diabetes using CGMs had a significantly lower HbA1c level and more time spent in the target glucose range in a 26-week trial.
    • “Adherence to the device was high, and no cases of severe hypoglycemia or hyperglycemia-related serious adverse events were observed.”
  • The Washington Post informs us,
    • “About 12 percent of new cancer cases worldwide in 2024 were caused by infectious agents such as viruses and bacteria, according to a recent study by the International Agency for Research on Cancer.
    • “That means a sizable share of the cancer burden around the world is preventable with tools we already have, including vaccines and other preventative measures, researchers said.
    • “We have very actionable targets,” said Gary Clifford, a cancer epidemiologist and one of the authors of the study that published in the Lancet Oncology. “We have very many tools against these viruses already.” * * *
    • “Existing measures like condoms, vaccines for HPV and cervical cancer screening can prevent infection and cancers associated with infectious diseases, experts said.”
  • and
    • “A woman’s ovaries bring center-stage energy for decades of her life: governing fertility and interacting with organs from the brain to the heart, from the skeleton to the immune system. Because of that, they have attracted scads of scientific research.
    • “But after menopause, around age 50, the spotlight on the ovary has historically gone dark. A study published Wednesday in the journal Aging Cell shows that an ovary continues to play an important role even in its retirement years, with functions that do not diminish and may still affect the rest of the body.
    • “Above all, the study underscores why the postmenopausal ovary is worthy of attention.
    • “Women are living three [more] decades with this organ in their body, and we have no idea what it’s doing,” Francesca Duncan, an associate professor of obstetrics and gynecology at Northwestern University said. “We really owe it to half our population to understand what’s happening.”
  • Contemporary OB/GYN adds,
    • “The American College of Obstetricians and Gynecologists (ACOG) has issued its most comprehensive guidance to date on managing menopause, with a new clinical practice guideline covering menopausal hormone therapy (MHT), nonhormonal medications, and nonpharmacologic treatment of vasomotor symptoms (VMS), sleep disturbance, and mood symptoms. Clinical Practice Guideline No. 13, published online October 15, 2026, in Obstetrics & Gynecology, replaces Practice Bulletin No. 141 from January 2014.
    • “According to the guidance, 50% to 92% of women in menopause report VMS, 16% to 66% of women in the United States report menopause-related sleep disruption, and more than one-third of perimenopausal and postmenopausal women worldwide report depressive symptoms. ACOG is also developing companion guidance on genitourinary syndrome of menopause, expected in 2027.” * * *
    • “View the complete and full guidance via Obstetrics & Gynecology, here.”
      .
  • Beckers Hospital Review notes,
    • “An Oct. 13 analysis from the Health Transformation Alliance examined linked claims and EHR data for 12.7 million patients from 2018 through 2025 to identify who is most and least likely to respond to GLP-1 therapy.”
  • Beckers Behavioral Health points out,
    • “Adults with schizophrenia and Type 2 diabetes who started a glucagon-like peptide-1 receptor agonist were less likely to be hospitalized or seen in the emergency department for psychiatric reasons than peers who started a dipeptidyl peptidase-4 inhibitor, a sodium-glucose cotransporter-2 inhibitor or none of the three drug classes, according to a study published in The Lancet Psychiatry.
    • “The results point to a possible psychiatric upside to GLP-1 therapy beyond blood sugar and weight control, though the study’s observational design means it cannot show the drugs caused the lower risk.”
  • and
    • “The rate of opioid use disorder diagnoses among commercially insured patients rose 32.7% nationwide between 2022 and 2025, FAIR Health found in its latest analysis of commercial health claims.
    • “The national rate reached 596 patients with an opioid use disorder diagnosis per 100,000 commercially insured patients receiving medical services in 2025, up from 449 in 2022. The findings were published as part of FAIR Health’s annual Opioid Tracker update, according to an Oct. 14 news release from the organization.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of two new treatments: nomlabofusp (Larimar Therapeutics, Inc.) and omaveloxolone (Skyclarys®, Biogen Inc.) for Friedreich’s Ataxia, a rare, genetic disorder. 
    • “Downloads: Draft Evidence Report | Draft Voting Questions
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.“

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

  • The Wall Street Journal reports,
    • “Pharmaceutical companies are investing billions of dollars into protein degraders, a new class of drugs designed to target disease-driving proteins.
    • “These drugs work by using a cell’s recycling system to destroy smooth proteins that traditional medicines can’t easily latch on to.
    • “While the FDA has approved a handful of these drugs, scientists are still working to ensure they don’t accidentally destroy healthy proteins.”
  • and
    • “AstraZeneca is partnering with Insitro to use artificial intelligence to find new treatments for cardiometabolic diseases.
    • “AstraZeneca will pay Insitro $40 million upfront and up to $1.46 billion if development and commercial targets are met.
    • “Insitro will use its AI platform to identify disease causes, while AstraZeneca will lead clinical development and commercialization.”
  • Beckers Health IT relates,
    • “Epic is working with Amazon Pharmacy, Mark Cuban Cost Plus Drugs and other pharmacy companies to develop a tool that will allow clinicians and patients to compare prescription drug prices directly within its EHR system.
    • “The new feature, called Prescription Marketplace, will allow clinicians and patients at health systems using Epic to compare medication prices across pharmacies before a prescription is sent, according to an Oct. 15 news release from the EHR vendor.
    • “The tool will display pharmacies’ cash prices alongside what patients would pay through their insurance plans, allowing them to determine whether paying cash could be less expensive.
    • “Amazon Pharmacy has worked with Epic since early 2025 to help develop the feature. Mark Cuban Cost Plus Drugs is also working with the company on its development, and executives from Costco and Eli Lilly’s LillyDirect voiced support for the tool in the release.”
  • Cardiovascular Business informs us,
    • “U.S. healthcare payment policies are accelerating physician consolidation and driving up the cost of care, according to Rick Snyder, MD, president of HeartPlace and chief physician executive at U.S. Heart and Vascular. He is also the vice president of the American Independent Medical Practice Association (AIMPA) and a former president of the Texas Medical Association. In addition, Snyder has held policy-focused positions with the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.
    • “In his role with AIMPA, he testified before Congress during this year’s House Energy and Commerce Committee hearings focused on healthcare affordability. He argued that the nation’s healthcare system spends more than any other country of healthcare, but has lower life expectance and poorer outcomes than other Western nations. According to Snyder, this is not due to a lack of spending, but a lack of cost efficiency.” 
  • MedTech Dive points out,
    • “Labcorp has agreed to buy certain laboratory testing businesses from Opko Health subsidiary BioReference Health for $722 million, plus an additional sum of up to $150 million tied to revenue from a prostate cancer blood test. The final purchase price could be adjusted based on closing revenues, the companies said Thursday.
    • “Labcorp is acquiring businesses focused on clinical and women’s health testing services, urology and diagnostic services provided to correctional institutions. The deal also adds more than 80 patient service centers to Labcorp’s network.
    • “In addition, the lab services provider is gaining BioReference Health’s 4Kscore test, which has Food and Drug Administration approval to help predict the likelihood of finding aggressive prostate cancer before a biopsy decision.”
  • and
    • “Zimmer Biomet said Tuesday it has inked a multi-year extension to its exclusive distribution agreement with Think Surgical.
    • “The deal, which extends an agreement signed in 2024, positions Zimmer to continue distributing an exclusive version of Think’s TMINI wireless handheld miniature robotic system. 
    • “Zimmer’s exclusive version of TMINI is compatible with its Persona knee system, a personalized product used in total knee replacements.”
  • Per Fierce Healthcare,
    • “The Elevance Health Foundation has launched a new prize program aimed at supporting solutions aimed at improving patient safety, with the first crop of winners targeting challenges like health literacy, fall prevention and medication errors.
    • “Elevance will dispense $4 million in prizes to four organizations through the first round of the program. The goal is to identify scalable, community-based solutions to tackle critical patient safety risks. The Patient Safety Prize falls under the foundation’s Community Action Leadership umbrella, and the team saw an opportunity to move beyond its core focus areas with these programs.
    • “The winners include: Care Synergy’s CAPABLE, or Community Aging in Place—Advancing Better Living for Elders, program; NYU Grossman School of Medicine; the Public Health Institute’s Population Health Innovation Lab; and the Parkland Center for Clinical Evaluation.”
  • Per Beckers Health IT,
    • “OpenEvidence drew 271 million queries from 952,008 U.S. clinicians between January 2024 and June 2026, according to a study published Oct. 15 in JAMA.
    • “Researchers from Somerville, Mass.-based Mass General Brigham and Boston-based Harvard Medical School analyzed query logs from OpenEvidence users with verified National Provider Identifiers. Vishal Patel, MD, and Samuel Finlayson, MD, PhD, contributed equally as lead authors, and Anupam Jena, MD, PhD, oversaw the study.
    • “Dr. Finlayson and two other co-authors, including OpenEvidence’s chief medical officer, were OpenEvidence employees during the study. The company provided the data and contributed to the analysis.
    • “Monthly active users grew from 355 in January 2024 to 703,265 in June 2026. Average monthly queries per active user rose from 18 to 39.5, and month-over-month retention climbed from about 70% to 90%.
    • “Physicians accounted for 556,200 users. Nurse practitioners and physician assistants used the platform most intensively, at 44.5 queries per active user-month, compared with 37.1 for physicians. Physicians within a decade of medical school graduation made up 24.3% of the physician workforce but submitted 61.8% of physician queries.”

Midweek report

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

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • “The Trump administration is delaying by 90 days a federal rule that could prevent Americans from obtaining prescription drugs from licensed international pharmacies.
    • “The move follows growing criticism that the rule, which was initially slated to go into effect on Oct. 22, could drastically reduce the flow of medicines from Canada and other countries. In recent weeks, patient advocacy groups and dozens of congressional lawmakers urged the administration to rethink its approach.” * * *
    • “This gives the FDA time to work with CBP to ensure a pathway for patients to continue importing more affordable prescription drugs for personal use when the rule is implement, based on identifiable safety criteria,” said Gabriel Levitt, who heads Prescription Justice, an advocacy group. “That’s what members of Congress have called for and that’s what the law says FDA should do.”
  • Per Department of Health and Human Services news releases,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. yesterday determined that public health emergencies exist in Florida and Alabama as a result of Hurricane Isaias. The determinations follow President Trump’s October 9 emergency declarations for both states (Florida, Alabama).
    • “The President’s declarations and the Secretary’s determination allow HHS to authorize temporary waivers and modifications of certain requirements. These flexibilities help the Centers for Medicare & Medicaid Services (CMS) support healthcare providers and suppliers serving people enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) in the covered emergency areas.” * * *
    • “Prior to landfall, ASPR pre-positioned regional staff in areas at risk from the storm to monitor the impacts on public health and healthcare systems and provide technical assistance in anticipation of state requests. Healthcare System Assessment Teams also deployed to evaluate the storm’s impact on healthcare facilities.
    • “In addition, ASPR shared HHS emPOWER datasets with states in the storm’s path. These data can help responders identify, by geographic area, the number of Medicare beneficiaries relying on electricity-dependent medical equipment or certain essential healthcare services, including facility-based dialysis and home healthcare.”
    • In declaring the public health emergency and authorizing flexibilities for CMS providers, suppliers, and beneficiaries, Secretary Kennedy acted within his authority under the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to October 6, 2026, in the state of Florida and October 7, 2026, in the state of Alabama.
  • and
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., joined by Health Resources and Services Administration (HRSA) Administrator Tom Engels, today launched the HHS Health Center Healthy Lifestyle Commitment, a voluntary initiative that encourages health centers nationwide to put nutrition, prevention, and healthy living at the center of patient care.
    • “Secretary Kennedy announced the initiative during a visit to Piedmont Access to Health Services (PATHS) health center in Chatham, Virginia, where he highlighted the role health centers play in preventing chronic disease and helping patients build healthier lives.”
  • PBS News tells us,
    • “Social Security checks will increase by roughly $76 per month for the average retired worker in 2027, the federal government announced Wednesday.
    • “The payment jump is due to the Social Security Administration’s annual COLA, or cost-of-living adjustment, which has been determined each fall for decades. Next year’s increase is 3.6%, based on inflation data, amounting to a little more than $900 next year.”
  • Govexec adds,
    • Because “[t]he Social Security Administration announced Wednesday that Social Security beneficiaries will receive a 3.6% cost-of-living adjustment next year, Federal retirees in the Civil Service Retirement System will therefore receive a 3.6% increase to their annuities next year, but former feds who are part of the Federal Employees Retirement System, launched in the 1980s alongside 401(k)-style Thrift Savings Plan, will see only a 2.6% adjustment.
    • “That’s because FERS’ annual cost-of-living adjustment is based on an extrapolation of the CSRS and Social Security increase. Each year, if CSRS sees an increase of less than 2%, FERS retirees receives the full COLA. But if the figure falls between 2% and 3%, FERS participants receive only a 2% increase, while if the COLA is 3% or more, like this year, FERS enrollees receive that adjustment, minus 1 percentage point.”

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

  • OPM posted in the Federal Register a direct final rule amending OPM’s Family and Medical Leave Act (FMLA) regulations in subpart L of part 630 of title 5, Code of Federal Regulations (CFR) to reflect statutory changes enacted in January 2021 and December 2023.
  • Per a U.S. Office of Personnel Management news release.
    • “U.S. Office of Personnel Management (OPM) Director Scott Kupor, Vice Chair of the Super Intelligence Task Force, joined Kayleigh McEnany on Fox News’ Saturday in America to discuss the task force’s work, the importance of U.S. leadership in SI, and the responsibility of technology companies to develop and release safe products.”
  • Govexec reports,
    • “The federal government’s human resources agency is revamping one of the most heavily trafficked tools on its website: annual pay tables for federal employees. 
    • “The Office of Personnel Management is planning to launch a new version of the online tables that agencies and employees use to look up federal pay rates each year.
    • “Adam Starr, the agency’s chief information officer, said on Wednesday that the agency’s pay rates website gets about 14 million visits each year, but hasn’t changed much since 2011. 
    • “I always like to remember that ‘OPM’ really stands for ‘other peoples’ money.’ And in this case, it is your money. People come to OPM pay tables, asking us to show them the money, and for years these have been legacy, clunky sites,” Starr said Wednesday at the SAP Public Sector Summit sponsored by GovExec. “It’s not the experience that a federal employee deserves.” 
    • “Starr said the revamped OPM pay tables will launch “later this calendar year,” in the first quarter of fiscal 2027.” 
  • A FedWeek article provides “a detailed explanation by OPM of changes in coverage terms for the 2027 plan year in the FEHB and PSHB programs, ahead of the open season that will run November 9 – December 14 (brochures with specifics by plan are to be released in early November).
    • FEHBlog observation: Historically the FEHB and PSHB plan carriers have posted their brochure on their websites before OPM does in early November.

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

  • Fox Business reports,
    • “More than 112,000 bottles of Amazon-branded extra-strength acetaminophen are being recalled after consumers reported discolored pills, according to the Food and Drug Administration (FDA).
    • “Aurobindo Pharma USA, a New Jersey-based pharmaceutical company, initiated the voluntary recall on Sept. 18, affecting three bottle sizes of Amazon Extra Strength Acetaminophen 500 mg caplets.
    • “The recall remains ongoing, according to the FDA.”
  • Cardiovascular Business adds,
    • “This voluntary recall includes 22 different lots of Argatroban Injection, a direct thrombin inhibitor used for prophylaxis or to treat blood clots in adult patients with heparin-induced thrombocytopenia (HIT). It can also work as an anticoagulant in adult patients with or at risk of HIT who are undergoing percutaneous coronary intervention (PCI) procedures. 
    • “According to new details shared by the U.S. Food and Drug Administration (FDA), the particulate matter in question has been identified as cellulose, polystyrene, polyethylene, terephthalate and stopper material. Some of it may also be stainless steel. The Argatroban Injection being recalled is delivered to a patient intravenously. If patients were treated with the contaminated drug, they would face a risk “life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels and/or inflammation of the wall of veins, which may lead to clotting.
    • “Par Health did emphasize that there have been no reports of adverse events related to this issue. 
    • “The drugs included in this recall were distributed by Par Pharmaceutical or Endo USA from December to May 2026. The lots are all set to expire as early as October 2026 and as late as September 2027.” 
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), given with Bacillus Calmette-Guérin (BCG), to include adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and has not responded to BCG treatment. Anktiva is the first FDA-approved treatment specifically for patients with BCG-unresponsive, high-grade papillary-only disease. 
    • “The approval marks a new FDA approach to evaluating treatments for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The agency based its decision on evidence supporting an earlier approval of Anktiva for adults with another form of NMIBC, carcinoma in situ (CIS), with or without papillary tumors, and scientific similarities between CIS and high-grade papillary-only disease.
    • “We listen to patients, clinicians, and researchers, and we act when the science supports a new approach,” said R. Angelo de Claro, M.D., Director of the FDA’s Oncology Center of Excellence. “For Anktiva, our review of the similarities between these cancers allowed us to build on the results in patients with CIS and expand treatment options for people with high-grade papillary tumors alone. This approach may also help guide the development of future treatments.”
  • Beckers Behavioral Health points out,
    • “The FDA has taken a string of actions in recent months that could reshape how substance use disorders, ADHD and other behavioral health conditions are treated in the years ahead. 
    • “From clearing a novel alcohol use disorder drug for trials to approaching the first new ADHD medication class in decades and backing psychedelic research under a White House directive, the agency’s recent moves point to accelerating momentum in behavioral health drug development.” 
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases. As outlined in a new white paper, the Initiative will develop an optimized, fit-for-purpose framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type and the evidence that can be realistically generated in small patient populations.
    • “To solicit feedback on the Rare Disease Framework Initiative from patients and disease advocates, industry, and others, the FDA will host an October 28 meeting at the FDA’s White Oak campus. The meeting will be facilitated by the Reagan-Udall Foundation for the FDA.”

No Surprises Act News

  • CMS announced
    • “Beginning November 13, 2026, organizations with IDR Gateway accounts can submit “Notice of IDR Initiation,” “Notice of IDR Initiation Response,” “Notice of Certified IDR Entity Selection,” and “Notice of Offer” web forms in the Independent Dispute Resolution (IDR) Gateway.
    • “IDR Gateway users can also view reports and access dispute records for disputes started within the IDR Gateway, as well as disputes started outside the IDR Gateway that were successfully mapped to an organization using the dispute mapping process.”

From the Medicare Advantage front,

  • The New York Times discusses CMS’s upgraded Medicare Plan Finder website.
    • “For the first time, beneficiaries and those who help them can type in the name of any licensed health care provider — not just doctors, which was the case last year — and find which Advantage plans they accept.”

From the Affordable Care Act marketplace front,

  • Modern Healthcare reports,
    • “A new draft regulation would tighten access to health insurance exchange subsidies as federal agencies continue implementing President Donald Trump’s tax law.
    • “The IRS issued a proposed rule Wednesday that would set stricter definitions of who qualifies for tax credit subsidies, toughen eligibility verification requirements and narrow access to financial assistance for noncitizens.
    • “This regulation would complement pending rules from the Health and Human Services Department and the Centers for Medicare and Medicaid Services.
    • “The IRS and the Treasury Department characterized the policies as part of broader Trump administration efforts to reduce fraudulent activity on the exchanges, such as removing enrollees from the rolls and freezing broker enrollment.
    • “The proposed rules protect eligible taxpayers while strengthening the integrity of the premium tax credit,” IRS CEO Frank Bisignano said in a news release. “The enhanced verification measures are designed to curb improper claims, ensuring these vital tax benefits go strictly to the hardworking Americans who qualify for them.”
  • Per an HHS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) continue to crush fraud, waste, and abuse in America’s healthcare programs by stopping duplicative enrollment in government health programs, with the potential to save taxpayers approximately $1.5 billion over the next year.
    • “In 2026, CMS identified 189,000 people who had subsidized Obamacare coverage through the Federal Marketplace and either had duplicate Medicare, Medicaid or Children’s Health Insurance Program (CHIP) coverage or were deceased. CMS took swift action to remove Obamacare subsidies for these people to save taxpayer dollars.”

From the public health and medical / Rx research front,

  • Reuters reports,
    • “The US CDC said on Tuesday it would deploy additional support to Pennsylvania to help investigate the ongoing measles ​outbreak, as the state formally requested federal assistance through the ‌agency’s Epi-Aid emergency response program.” * * *
    • “The agency said it would work with local health officials to investigate the outbreak, strengthen response efforts and prevent spread.
    • “Texas, South Carolina, Virginia, Kansas, New ​Mexico, and Wisconsin requested CDC Epi-Aids and worked alongside federal teams to ​help bring their outbreaks rapidly and successfully under control,” the agency said in a ‌statement.”
  • The New York Times relates,
    • “Pope Leo XIV had a “good” second night in the hospital after surgery to remove a cancerous nodule on his lung, the Vatican said on Thursday.
    • “The pope had a good night in the hospital. He got up and had breakfast,” the Vatican said on Thursday morning.
    • “Leo’s lung cancer diagnosis has cast uncertainty over his agenda and raises questions about succession about a year and a half into his papacy.
    • “The Vatican said that doctors operating on the pope in Rome on Tuesday confirmed he has ​lung adenocarcinoma, a common form of lung cancer that can be highly treatable when caught early. Surgeons removed the lower lobe of his right lung.”
  • Healio tells us,
    • “In 2023, the age-standardized mortality rate for asthma was lower than that of 1990 by 50.94%, whereas the 2023 rate for COPD was higher than the 1990 rate by 8.9%, according to data published in The Lancet Respiratory Medicine.” * * *
    • Between 1990 and 2023, the estimated number of people living with chronic respiratory disease in the U.S. rose from 33.28 million to 54.5 million.
    • “Increases between these years were also observed in the age-standardized prevalence rate (+10.24%) and the age-standardized mortality rate (31.19 per 100,000 population to 34.56 per 100,000 population). According to researchers, the modest increase in the mortality rate signals “persistent gaps in disease control.”
    • “When broken down by disease type, the study found that the age-standardized mortality rate in 2023 was higher than that of 1990 for COPD (+8.9%) and ILD and pulmonary sarcoidosis (+87.47%), whereas the 2023 rate was lower than the 1990 rate for asthma (–50.94%) and pneumoconiosis (–75.19%).” * * *
    • “Integrating tobacco control measures, equitable vaccination programs and targeted health-system investments could help to address the uneven burden of chronic respiratory diseases across U.S. states and the growing mortality gap despite stable prevalence, although further research is needed to clarify which specific policy determinants underlie these associations,” Yon and colleagues wrote.”
  • and
    • “Women with polycystic ovary syndrome, now known as polyendocrine metabolic ovarian syndrome, may have elevated risk for Alzheimer’s disease and related dementias, a review article stated.
    • “However, the higher risk may be mediated by metabolic disorders, the researchers wrote. 
    • “In findings published in the Journal of the Endocrine Society, researchers identified multiple studies that reported people with PCOS/PMOS have increased risk for Alzheimer’s disease and dementia. However, there remain several unanswered questions, including whether PCOS/PMOS independently raises Alzheimer’s disease risk and if any interventions may reduce the elevated risk in the PCOS/PMOS population. 
    • “The data indicate that it is critical to further assess the possible link between PMOS, metabolic dysfunction and Alzheimer’s disease, but we should recognize that according to the information we reviewed, this link is still hypothetical and much more research is needed,” Ricardo Azziz, MD, MPH, MBA, executive director at the Foundation for Research & Education Excellence and professor in the School of Medicine and School of Public Health at University of Alabama at Birmingham, told Healio.”
  • Radiology Business tells us,
    • “Researchers have developed a way of adapting adult radiology artificial intelligence models for the pediatric population. 
    • “Currently, only about 17% of U.S. Food and Drug Administration-authorized AI medical devices are labeled for use with children. That’s because most models are trained on adult data and do not translate well for infants and kids, experts write Tuesday in Nature Biomedical Engineering. 
    • “One key impediment is that medical records in pediatrics are subject to strict privacy regulations, with data tending to remain at the institution where treatment occurred. Currently, kids represent less than 1% of public medical imaging datasets. 
    • “Because it’s so much harder to get data for children, this transformative technology is disproportionately being developed to help adults,” lead author Vishwanatha Rao, a MD-PhD student with the University of Pennsylvania and research fellow at Harvard, said in a statement Oct. 13. “Children are being left behind.”
    • “To address this, Rao and colleagues championed a way of adapting one model, trained on adult X-rays, for the pediatric population. Their approach used data from multiple hospitals without sensitive information ever leaving each institution. “The model travels, but the data stays in-house,” experts noted.” 
  • Genetic Engineering and Biotechnology News notes,
    • “Researchers at Baylor College of Medicine, the Duncan Neurological Research Institute (Duncan NRI) at Texas Children’s Hospital, and collaborating institutions have identified new genetic candidates that help explain why autism is diagnosed about four times more often in boys than it is in girls. The study, involving tests in induced pluripotent stem cell (iPSC)-derived neurons (iNeurons), revealed that small changes in the gene MECP2 on the X chromosome might help explain part of this difference.
    • “Huda Zoghbi, MD, Distinguished Service Professor at Baylor, director of Duncan NRI, and a Howard Hughes Medical Institute investigator, is senior and corresponding author of the team’s published paper in The American Journal of Human Genetics, titled “A massively parallel reporter assay of MECP2 cis-regulatory elements reveals genetic candidates for male-biased autism.” In their paper, the team concluded, “These findings suggest noncoding MECP2variants can cause idiopathic, male-biased autism and provide a framework for uncovering regulatory variants in other X chromosome neurodevelopmental genes that may contribute to autism’s missing heritability.”
  • MedPage Today informs us,
    • “There are no licensed vaccines targeting invasive E. coli disease, an acute illness that can lead to sepsis and death.
    • “In a phase III trial of older adults, the nine-valent ExPEC9V vaccine’s efficacy rate of 14.6% indicated no protective effect against invasive E. coli disease.
    • “The results led to an early termination of the trial, and development of the vaccine has been discontinued.”
  • Per Bio-Pharma Dive,
    • “An experimental RNA interference drug developed by Arrowhead Pharmaceuticals lowered levels of an Alzheimer’s-linked protein in an early trial in healthy volunteers, signaling the medicine might be helpful in treating the memory-robbing condition.
    • “Arrowhead said the highest dose of its drug, administered in two injections spaced two weeks apart, dropped levels of that protein, “tau,” by an average of 73% after 105 days. The findings suggest the medicine, called ARO-MAPT, could be injected once every three months.
    • “The news comes as developers of RNA-modulating medicines have been increasingly exploring ways to overcome a longstanding research limitation by aiming their treatments at targets outside the liver. Arrowhead said the results from this early-stage trial “provide clinical validation” of a development platform that enables its drugs to reach cells elsewhere, including those in the central nervous system protected by the “blood-brain barrier.”
  • and
    • “Verastem Oncology shares rose 18% Wednesday after the company released highly anticipated early data suggesting its experimental cancer drug could help certain patients with three different types of tumors.
    • “The drug, VS-7375, targets the most prevalent of the “KRAS” mutations that drive cancer, one known as G12D. The medicine is designed to bind to both the “on” and “off” states of the mutation, which may allow it to hold back tumor growth more completely than rival treatments that only target one or the other, Verastem said.
    • “The small study included patients with metastatic pancreatic ductal adenocarcinoma, metastatic colorectal cancer and advanced non-small cell lung cancer. Based on the results, the company plans to kick off a trio of late-stage trials before the end of June.”

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

  • Human Resource Director reports,
    • “Employer health costs are on track to rise 8.2 percent per employee in 2027, the steepest increase since 2003, and many employers say they cannot get the claims data needed to explain why.
    • “Marsh, the benefits consultancy formerly known as Mercer, reached that figure in its 2026 National Survey of Employer-Sponsored Health Plans, which collected responses from more than 1,800 US employers between June 10 and August 10, 2026. Employers said costs would climb 11 percent if they took no action, and 59 percent plan cost-cutting changes such as higher deductibles. A separate Marsh survey found that about two-thirds of employers with 500 or more workers expect to raise employees’ share of premiums, so many workers will see paycheck deductions rise by more than the average. Aon and Business Group on Health have published similar pre-mitigation forecasts of 9.5 percent and 9.2 percent for 2027.
    • “Our report on Marsh’s 2027 health benefit cost projections covers the three newer drivers. Marsh’s actuaries attribute roughly one percentage point each to glucagon-like peptide-1 (GLP-1) weight loss drugs, artificial intelligence (AI)-enabled claims submission software and disputes under the No Surprises Act’s Independent Dispute Resolution (IDR) process.”
  • Beckers Hospital Review relates,
    • “Chicago-based Rush University System for Health and Evanston, Ill.-based Endeavor Health announced plans to merge Oct. 14. The transaction is expected to close in early 2027.
    • “Endeavor plans to fund a $1 billion investment as part of the deal, including $300 million to broaden community impact, $500 million for academics and research, and $200 million for quality care and innovation, according to a joint press release. The investment will also fund community partnerships focused supporting social determinants of health and underserved members of the community.
    • “Together, Rush and Endeavor Health have an opportunity to create a stronger, more connected health system that sets a new standard for how care is delivered and experienced across our communities,” said Gerald “J.P.” Gallagher, president and CEO of Endeavor. “Patients and communities will benefit from improved access, advanced research and nationally recognized, high-quality care close to home.”
    • “When the deal is finalized, the system will operate under the Rush brand based on the brand’s “strong national reputation and position as a leading academic institution,” according to the press release, with a commitment to academics, care quality and innovation.”
  • and
    • “Greensboro, N.C.-based Cone Health is sunsetting its Hospital at Home program, according to an Oct. 14 statement from the health system shared with Becker’s. 
    • “Cone Health made the decision following a comprehensive review of its priorities and the model’s sustainability. 
    • “The statement noted that health systems across the U.S. continue to evaluate hospital-at-home programs as they navigate evolving reimbursement models, operational complexity and long-term sustainability. 
    • “The program, which launched in April 2025, reported strong first-year results on June 1, including no patient deaths or healthcare-acquired infections. Cone Health had limited the program to six patients at a time and had planned to expand it once more payers covered the model.” 
  • Healthcare Dive adds,
    • “Nonprofit health systems MultiCare and Samaritan Health Services will merge on Nov. 1 after gaining approval from state regulators, the companies announced Monday.
    • “As part of the deal, MultiCare – which operates 13 hospitals –  will begin an affiliation with Samaritan and its network of five hospitals. MultiCare, which is based in Tacoma, Washington, will also invest $700 million over 10 years into Oregon-based Samaritan. Samaritan will continue to use its name, alongside MultiCare’s branding, the health system said.
    • “This milestone brings us closer to putting the investment and resources of our partnership to work for the people we serve.” said Marty Cahill, Samaritan president and CEO, in a statement.”
  • Modern Healthcare tells us,
    • “Elevance Health is distinguishing itself from other insurers by proactively, and publicly, railing against high costs it says are driven by providers. 
    • “The insurer announced last year that its Anthem Blue Cross Blue Shield commercial plans would penalize healthcare facilities with a fee up to 10% if out-of-network clinicians are deployed for elective surgeries. That policy was soon expanded to additional states.
    • Last month, Elevance Health tightened the screws again by becoming the first insurer to require that hospitals identify and charge correct rates for off-campus care.
    • “Elevance Health’s site-of-care policy represents a “relatively consumer-protective attempt at reducing spending,” said Christine Monahan, an associate research professor at the Georgetown University Center on Health Insurance Reforms.
    • “Hospitals, however, have already begun to challenge the restrictions, which they deem as unilaterally imposed on them in spite of their contracts with the insurer. It’s possible more health systems will sue, said John Barnes, a partner at law firm Davis Wright Tremaine who represents providers on issues concerning insurance contracts.”
  • and
    • “Zocdoc, a virtual marketplace for booking providers, has acquired insurance technology company Sohar Health.
    • “The deal marks Zocdoc’s first acquisition since launching in 2007, according to a Wednesday press release. Zocdoc declined to disclose the financial terms of the acquisition, which closed on Oct. 2.
    • “Sohar’s platform automates insurance benefits eligibility checks.”
  • MedTech Dive informs us,
    • “Steris said Monday it struck a $2.1 billion deal to acquire Xodus Medical for its portfolio of consumable healthcare products. 
    • “Xodus’ portfolio includes Pink Pad patient-positioning products and the See Sharp laparoscopic cleaning and defogging device. The company expects annual sales to hit $245 million this year.
    • “Buying Xodus “makes sense” for Steris because it expands the company’s healthcare consumables offering with high-growth, high-margin products, Needham analysts said in a note to investors.”
  •  and
    • “Agilent said Tuesday that it has agreed to buy digital pathology software provider Proscia for $240 million upfront.
    • “The deal, which includes up to $30 million in milestones, will give Agilent control of technology that connects slide scanners, laboratory information systems and other parts of the pathology workflow.
    • “Agilent’s deal comes months after Roche agreed to buy PathAI for up to $1.05 billion. Evercore ISI analysts noted that Agilent “got the rights to play in this market at a lower price point.”
  • Beckers Health IT points out,
    • “The American Hospital Association, American Medical Association, Anthropic and Elevance Health are participating in a national workgroup developing recommendations for how state medical boards should oversee AI in medical practice, a spokesperson for the Federation of State Medical Boards confirmed to Becker’s.
    • “FSMB announced the workgroup in May to develop recommendations and/or model guidelines for state medical boards, particularly regarding AI systems that perform clinical functions with limited or no direct physician supervision. The effort comes as companies test how AI can be used in diagnosis, prescribing and other clinical functions, and as states propose and implement regulatory sandbox frameworks, according to FSMB’s news release.
    • “The group met in Washington in early October, the FSMB spokesperson confirmed to Becker’s.”
  • Fierce Healthcare adds,
    • “Johns Hopkins Medicine is teaming up with OpenEvidence to advance the use of artificial intelligence in medical education and clinical care.
    • “OpenEvidence and Johns Hopkins executives provided Fierce Healthcare with a first look at the partnership news.
    • “The health system and academic institution will partner with OpenEvidence to develop what they describe as “human-first AI systems” that combine the best available evidence with a patient’s medical history and Johns Hopkins’ clinical best practices to support care delivery. Sophisticated AI will help clinicians reason through that information more quickly, contextualize it, and make the best decisions for their patients, executives said.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the frontier artificial intelligence front

  • The Wall Street Journal reports,
    • “Rogue AI models have hacked companies and tried to break into government websites. Now one has submitted a fake tip for an unsolved crime.
    • “Police in Philadelphia say Anthropic alerted them this week that one of its artificial-intelligence models submitted a false homicide tip through PhillyUnsolvedMurders.com. 
    • In a blog post, Anthropic said the fake tip was among a group of rogue actions the company uncovered recently. The rogue activity also involved websites run by U.S. government agencies at the federal, state and local levels. The company said it has briefed the White House on these cases and notified each agency involved, and plans to report new instances of unintended AI behavior as it uncovers them.
    • “While these cases had minimal impact, we do not want to diminish the findings, because the same behaviors could do far more harm as models become more powerful,” Anthropic said in the blog post.
    • “The false-report incident happened in July. Anthropic didn’t realize it until September.”
  • and
    • “Anthropic edged to the front of the AI race earlier this year with cutting-edge models and a coding tool that corporate America loved. By some measures, OpenAI is now hot on its heels.
    • Demand for Anthropic’s Claude Code was so strong in the spring that the company faced frequent outages and a computing crunch. 
    • “But businesses grappling with mounting costs as more employees experimented with artificial intelligence realized they didn’t always need the most advanced options for most tasks. Companies, which now use a variety of models, increasingly turned to low-cost, open-weight models from China for some tasks. And some Claude users balked at guardrails Anthropic put on its powerful Fable 5 model when it was released in early June.
    • “OpenAI stoked the price war this summer with the release of its GPT-5.6 lineup—Sol, Terra and Luna—giving customers access to models with varying capabilities, including some that are less expensive to run. Its Codex coding product and other business tools are now gaining ground, and it has released additional iterations of its cost-efficient models.
    • “An analysis from OpenRouter, a startup that allows developers to access different models, found that among some 120,000 companies that use Anthropic and OpenAI tools, the share of spending was roughly even between the two AI giants in September. At the beginning of the year, Anthropic commanded three-quarters of that total. OpenRouter said its data largely represents spending by AI-native startups as well as some slightly older tech companies and large enterprises.”
  • and
    • “Mistral said it would soon release a new open-weight AI model that it claimed would rank among the best globally, part of efforts to grow its appeal, lock in more customers and better compete with U.S. rivals.
    • “The French artificial-intelligence startup said it was launching a public preview of Mistral Large 4, dubbed Le Chonk, on Tuesday so it could work with developers, cybersecurity experts and state authorities to evaluate how the model behaves. It plans to release the weights, or the trained parameters of the model, on Oct. 27.
    • “Since its early days, Mistral has been a staunch advocate of open-weight models that are publicly available for anyone to download and modify, saying they give users the flexibility to tailor them to their needs while protecting their data and intellectual property.”

From the cybersecurity policy and law enforcement front

  • The Wall Street Journal reports,
    • “A new White House task force will have 120 days to report on the risks and opportunities of artificial intelligence—and determine the federal government’s responsibility—according to Jay Clayton, the director of national intelligence who effectively becomes the administration’s AI czar.
    • “The president asked that a group be put together that was going to ensure exactly what he said,” Clayton said, that “we stay the leaders in superintelligence, and that the interests of the American people are put first.” 
    • “Clayton will chair the “Super Intelligence Force” which takes President Trump’s preferred name for AI: super intelligence or SI.
    • “The risk of not being first is high,” Clayton said. “Not being first increases the identified, and unidentified, risks, particularly from our adversaries. Being first will better enable us to address those risks on behalf of the American people,” he added.” * * *
    • “The task force will have three vice chairs: Emil Michael, undersecretary of war for Research and Engineering, who will be responsible for coordination with AI companies; Scott Kupor, director of the Office of Personnel Management, who will be responsible for coordination with critical infrastructure providers and other industry stakeholders; and Andrew Ferguson, chairman of the Federal Trade Commission, who will oversee consumer interests and groups advocating for people of faith, children, privacy, freedom of speech, freedom of expression, and freedom of association.”
  • Cyberscoop relates,
    • “Federal government contractors that handle sensitive information could soon face a “sea change” in rules about how they protect that information and report when it has been part of a breach.
    • “Pending federal regulations on the handling of “controlled unclassified information,” or CUI, a category of sensitive data that falls short of classified — including people’s personal information such as Social Security numbers, information that could expose vulnerabilities in critical infrastructure and more — could arrive as soon as the end of this year, but likely no later than the end of President Donald Trump’s term, attorneys who specialize in federal procurement rules said. The changes are part of a larger overhaul of federal contracting rules.
    • As currently written, the proposed CUI rules mandate that unauthorized access of such data, including as a result of a cyberattack, would have to be reported to the federal government within 72 hours of discovery. The rules are a companion for most federal agencies to existing  Defense Department rules that cover the same subject. The 72-hour notice also is deliberately aligned with forthcoming rules from the Cybersecurity and Infrastructure Security Agency (CISA) for critical infrastructure owners and operators to report major cyber incidents under the Cybersecurity Incident Reporting for Critical Infrastructure Act (CIRCIA).” * * *
    • The other major aspect of the proposed rule is that contractors handling CUI would have to abide by certain cybersecurity standards set by the National Institute of Standards and Technology known as SP 800-171, which [Trayce] Howard and her Wiley [Rein] coauthors said would be imposed “on a broader group of contractors than ever before.” Some contractors might also have to meet other cybersecurity requirements, too.
    • “Another thing that will affect contractors is they’re going to have to flow down these requirements to their subcontractors,” she said. “So they’re going to have to identify what CUI am I giving to my subcontractors, and do some sort of oversight to make sure that their subcontractors are appropriately handling CUI.”
  • Cybersecurity Dive tells us,
    • “U.S. government agencies are failing to prepare for the transition to post-quantum encryption, creating the risk that their sensitive data will still be vulnerable to decryption by quantum computers whenever those machines are deployed, according to the Government Accountability Office.
    • Experts are divided over when the advent of cryptographically relevant quantum computers (CRQC) will occur, but GAO bluntly declared in a report published Tuesday [October 6]  that “threats from a CRQC could have devastating impacts to federal systems reliant on vulnerable cryptography.” * * *
    • “In a version of the report not publicly released, GAO recommended 89 actions that CISA and other agencies could take to increase their preparedness. Of the 23 agencies to which GAO assigned recommendations, only 12 fully agreed to implement them. “We continue to believe that all of the recommendations made in the sensitive report are warranted,” GAO said.”
  • The Wall Street Journal notes,
    • A bipartisan group of federal lawmakers is pressing Congress to increase mental-health funding for personnel at U.S. Cyber Command in the wake of several suicides this summer at the command and the National Security Agency. In separate letters, members of the House Armed Services cyber subcommittee and Maryland lawmakers urged leaders of the House and Senate Appropriations panels to back an $11 million request for “High Performance Team Training” at the command. (The Baltimore Banner)
  • and
    • German officials said they infiltrated ransomware group Qilin and detained a 28-year-old Russian national believed to be one of the group’s leaders. The arrest follows months of covert monitoring of Qilin’s activities, the official said. The group is alleged to have demanded more than $3 billion in ransom payments over the past two years from targets around the world. (LIGA)
  • The New York Times adds,
    • “The F.B.I. has arrested a Canadian cybersecurity expert in Pennsylvania on suspicion of carrying out the computer hack that stole sensitive information about thousands of F.B.I. employees, according to two people familiar with the matter.
    • “The theft of reams of personal data last month by a criminal hacking group that calls itself ShinyHunters left the nation’s premier law enforcement agency racing to respond to the investigators and the victims of one of the worst breaches of government data in recent years.
    • “The arrested man is Edward Dubrovsky, who has helped firms victimized by hackers and is now considered by federal authorities to be a primary co-conspirator in the ShinyHunters attack on F.B.I. data, the people said.
    • “Mr. Dubrovsky is the author of a book published last month titled “Cyber Extortion Strategic Response.” While the details of the charges against Mr. Dubrovsky remain under seal in Texas, federal court records in Philadelphia show that he was charged with conspiracy to commit extortion. Mr. Dubrovsky is expected to be transported to Texas to face the charges.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) today announced a settlement with Linda L. Shen d/b/a Shen Smiles, P.C. (Shen Smiles), a Pennsylvania-based healthcare provider that offers dental services, for potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The settlement resolves an investigation of a complaint alleging a failure to provide timely access to an individual’s protected health information (PHI).”
    • “The Notice of Proposed Determination may be found here.
    • “The Resolution Agreement may be found here [PDF, 161 KB].”

From the cybersecurity breaches and vulnerabilities front

  • HIPAA Journal reports,
    • “The scale of a 2025 data breach involving electronic protected health information stored on Oracle Health’s legacy Cerner servers is becoming clearer. While not independently verified, Bloomberg reports that the Texas Attorney General released information suggesting that the protected health information of almost 20 million individuals was compromised in the incident. Oracle Health has not publicly disclosed how many Cerner clients were affected, or the total number of individuals affected.”
  • Security Week relates,
    • “Healthcare organizations Clover Health Investments and AngMar Management Services are notifying more than 250,000 people that their information was stolen in separate data breaches.
    • “Jersey City, New Jersey-based Clover Health Investments was hacked in early July, after attackers used social engineering to compromise three non-managerial health plan employee accounts.
    • “The incident resulted in the theft of personally identifiable information (PII) and protected health information (PHI), the company said in an SEC filing in July.
    • “The potentially affected information included names, dates of birth, insurance identifiers, and account identification numbers, the company revealed.
    • “In mid-September, Clover Health Investments told the US Department of Health and Human Services (HHS) that 138,677 people were affected. HHS added the company to its data breaches portal last week.
    • “Mansfield, Texas-based AngMar Management Services identified suspicious activity on its systems in mid-July and confirmed in early September that hackers stole patient PII and PHI.
    • “AngMar Management Services provides business operations, administration, and support network management for home health and hospice care providers.”
  • The American Hospital Association News tells us,
    • “The FBI and Secret Service released an advisory Oct. 6 warning of ongoing activities by FortiBleed, a global credential-compromise campaign used by threat actors to target internet-facing Fortinet FortiGate firewalls and virtual private network gateways at critical infrastructure organizations. The agencies said the campaign exploits reused or leaked credentials and legacy password storages, allowing threat actors to harvest and decode authentication data at scale. Impacted organizations could be locked out of their systems if threat actors disable accounts or change passwords and would require remediation actions beyond typical patching and password resets. The advisory includes indicators of compromise and mitigation actions to defend against potential attacks.”
  • and
    • “A joint advisory released Oct. 8 by U.S. and international agencies warns of Chinese government-linked cyber threat actors using automated and hands-on hacking tools to steal sensitive data from critical infrastructure organizations, including healthcare, across the U.S. and abroad. The advisory said that the threat actors are enabled by the Integrity Technology Group, a China-based company with links to the Chinese government. The agencies said the threat actors are using automated scanning tools, large-scale botnets and hands-on exploitation techniques to attack Microsoft Exchange servers and virtual private network software. The advisory includes recommendations to help mitigate risk from potential attacks.” 
  • Cyberscoop adds.
    • “The Justice Department and FBI announced that they had seized two hacking tools connected to the Chinese government-linked group Flax Typhoon and a China-based company that the U.S. government has repeatedly taken action against, including with a new multi-agency advisory Thursday.
    • “The domain name seizures were meant to deny hackers access to the vulnerability scanning tool Microscan and the spearphishing tool FishHub created by the Chinese firm Integrity Technology Group, which the United States sanctioned last year. The U.S. government in 2024 also made the company the focus of a takedown operation, saying it was behind a massive botnet.
    • “U.S. agencies paired the announcement of the seizures with an Oct. 8 advisory from the FBI, Cybersecurity and Infrastructure Security Agency and National Security Agency.”
  • CISA added one known exploited vulnerability to its catalog this week.
    • October 4, 2026
      • CVE-2026-88779 Citrix NetScaler Improper Restriction of Operations within the Bounds of a Memory Buffer Vulnerability
        • Cyber Press discusses this KVE here.
  • Bleeping Computer notes,
    • “Attackers are exploiting a maximum-severity vulnerability in SonicWall SMA1000 appliances (CVE-2026-102255) that was patched on Tuesday, three days ago.
    • “Tracked as CVE-2026-102255, the flaw affects the Appliance WorkPlace interface on SMA1000 6210, 7210, and 8200v models, but does not affect the SMA 100 Series product line or SSL-VPN running on SonicWall firewalls.
    • “By abusing this path, a remote unauthenticated attacker could potentially exploit this vulnerability to direct the appliance to issue requests on their behalf and reach internal functionality and perform unauthorized operations,” SonicWall explained.”
  • and
    • “Citrix has warned IT administrators to patch systems immediately against a new critical vulnerability affecting NetScaler ADC networking appliances and NetScaler Gateway secure remote access solutions.
    • “Tracked as CVE-2026-107406, this flaw stems from a memory overflow weakness that attackers can exploit to gain remote code execution (RCE) on targeted devices or trigger a denial-of-service state that can cause crashes.
    • “To be vulnerable, NetScaler ADC and NetScaler Gateway appliances must be configured as a Security Assertion Markup Language (SAML) Identity Provider (IdP) or Service Provider (SP).
    • “We strongly urge affected customers to review the advisory and upgrade impacted NetScaler instances to the recommended versions as soon as possible,” the company said. “As of the publication of the bulletin, Citrix is not aware of any unmitigated exploits of this vulnerability.”
  • Per Cybersecurity Dive,
    • “Hackers may be using AI more frequently and in more ways, but their top priority is still subverting identity controls, the identity-security firm Okta said in a report published on Wednesday.
    • “The report included data about the frequency of different kinds of account takeovers and a reality check to enterprises that AI shouldn’t fundamentally change their calculus when it comes to identity management.
    • “In a separate report also published on Wednesday, Okta detailed how hackers are trying to bypass strong authentication controls to sneak into accounts, underscoring the need for vigilance among both system administrators and regular employees.”
  • Security Boulevard adds,
    • “An analysis of 150 billion transactions flowing through Domain Name System (DNS) servers published today by EfficientIP finds that malware has overtaken phishing as the threat vector now being detected most.
    • “The latest DNS Threat Intelligence Report from EfficientIP finds malware has climbed from fourth place in the second half of 2025 to first in daily activity, having roughly quadrupled between a January and an April peak of 32.6 million instances.
    • “Yaelle Harel, principal security market strategist for EfficientIP, said that while there is no conclusive evidence, that level of increase suggests cybercriminals may now be leveraging artificial intelligence (AI) tools to both create malware and launch attacks faster using newly acquired IT infrastructure resources.”

From the ransomware front

  • Info Security Magazine reports,
    • “Ransomware attacks reached their highest ever quarterly volume in the third quarter of 2026, according to an analysis by Comparitech.
    • “The firm identified a total of 2627 claimed attacks during the three-month period from July to September 2026. This is a 27% increase on the previous quarter, Q2 2026, and a 61% rise compared to Q3 2025.
    • “The finance and technology sectors experienced the biggest growth in ransomware incidents in Q3 compared to Q2 2026, up by 72% and 70%, respectively.
    • “Other critical sectors faced a significant rise in attacks, including education (up 50%), healthcare (39%), government (36%) and utilities (32%).
    • Of the 2627 attacks claimed by ransomware groups in Q3, 247 have been confirmed by the entity involved, Comparitech found.
    • “Rebecca Moody, head of data research at Comparitech, said that the figures are highly unusual, and represent a significant cause for concern.: * * *
    • “A possible explanation for the surge is developments in AI technology, which is enabling ransomware attackers to increase the scale and speed of campaigns, as well as their effectiveness.” * * *
    • “The report highlighted an increase in attackers using triple extortion tactics on victim organizations. In this model, in addition to encrypting systems and exfiltrating data, threat actors also target individuals impacted in the attack.
    • Moody added that this tactic further demonstrates that paying a ransom is no guarantee that the attacker will keep to their word regarding deleting stolen data.
  • Recorded Future News relates,
    • “The University of Illinois Chicago (UIC) recently discovered a ransomware attack that limited access to some systems at its College of Medicine.  
    • “A spokesperson for the university told Recorded Future News the hackers were able to steal some information held on the college’s servers and an investigation is underway to determine whether “any personal, research or academic information was compromised.” 
    • “As a result of this ransomware event, some College of Medicine systems were temporarily unavailable,” the spokesperson said. “However, all affected systems have since been restored. The university’s main network was not affected, and there was no impact on patient care delivery at UI Health.” * * *
    • “The attack was claimed last week by a ransomware gang known as Booba, which claimed to have stolen 344 gigabytes of data. The group emerged at the end of July and has already claimed 49 attacks. 
    • “SentinelOne’s Brett Williams said the group appears to be a rebrand of the Frag ransomware based on the leak site’s style and negotiation flow. Encrypted files are renamed with the .booba extension and there appears to be variants for Linux as well as Windows.  
    • “The group has targeted several companies and small county governments, including Merrimack County, New Hampshire.” 
  • Cyberscoop tells us,
    • “Authorities accuse the owner of a so-called ransomware remediation company of swindling clients victimized by ransomware attacks into paying the company inflated fees under false pretenses.
    • “Zohar Pinhasi, owner and operator of MonsterCloud, claimed he could decrypt and recover victims’ data with specialized, proprietary tools and avoid paying cybercriminals. Yet, no such tool existed, the Justice Department said Wednesday [October 7]. 
    • “Pinhasi allegedly used MonsterCloud clients’ fees to pay off cybercriminals and recover encrypted data without telling clients ransom payments were made on their behalf. The dual “U.S.-Israeli national is accused of charging hundreds of clients more than $19 million and paying more than $8 million in ransom payments during a five-year period ending in 2023.
    • “It baffles me that companies fall for this,” Jon DiMaggio, principal researcher at Arkem Cyber, told CyberScoop. “I mean, they just got hacked and they go straight to a shady source.”

From the cybersecurity business and defenses front,

  • Cybersecurity Dive discusses what the C-suite needs to know about AI governance
    • “As AI adoption surges, executives are learning tough lessons about security, oversight and accountability.”
  • The American Hospital Association News tells us,
    • The National Security Agency Oct. 8 released guidance for critical infrastructure organizations that recommends adopting high-impact zero trust strategies to improve cybersecurity for operational technology. For healthcare, such technology includes tools that manage energy control, HVAC, life-safety systems, door access controls, physical security systems, alarms and medical gasses. Zero trust is a security principle that assumes a compromise is possible or already present and continuously verifies users and devices. The guidance also highlights recent nation-state attacks, including the People’s Republic of China’s prepositioning of disruptive malware known as Volt Typhoon on critical infrastructure entities that healthcare depends on, such as energy. The guidance also explains how threat actors’ use of artificial intelligence is making cyberattacks more sophisticated and potentially more severe.
  • Security Week points out,
    • “All enterprises conduct security awareness training for their employees. But whether this has tangible benefits is debatable.
    • “Empirical evidence suggests that security awareness training isn’t working – successful attacks keep increasing. But opinions on the efficacy of awareness training range from it doesn’t work to it does work, with sometimes, perhaps and depends between the two extremes.
    • “Awareness training focuses on two tasks: to reduce the effect of bad judgment turning an employee into an insider threat; and to harden employees against falling to malicious social engineering. We focus on social engineering.” * * *
    • “Sanny Liao, co-founder and CPO at Fable Security, says bluntly, “For the most part, security awareness training as done today does not work. Social engineering continues to succeed because attackers exploit context, timing, and psychology, while most training remains generic, infrequent, and removed from the moments when employees are actually making decisions.”
    • “She hints at a novel approach. “One place the industry can look for inspiration is adtech. Marketers have gotten remarkably good at changing behavior by delivering the right message at the right time based on context. Security awareness has largely done the opposite by giving everyone the same training at the same time, regardless of the decisions they’re making or the risks they face. When organizations change behavior instead of simply raising awareness, employees stop being viewed as the weakest link and start becoming an active part of the organization’s security defenses.”
  • Per a NIST news release,
    • “For small businesses who are often confronted with limited resources, knowing how to get started and where to find support with planning, implementing, or evaluating a cybersecurity risk management strategy can be challenging — sometimes making cybersecurity feel like an insurmountable hurdle. However, there is good news.
    • “Many non-profit organizations across the United States have created programs for their local small business communities (in addition to local schools, municipal governments, and non-profits) that often extend beyond general cybersecurity education to include services like conducting risk assessments and penetration tests, performing compliance consulting services, helping with incident preparedness and response measures, and more.
    • “The NIST Small Business Cybersecurity Support Program Finder brings these programs together into one tool, connecting small businesses with local non-profit community partners who help with cybersecurity risk management.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Medicare, NCQA, U.S. Healthcare–

Simplicity is a virtue.

From Washington, D.C.,

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Oct. 9 released its first report on how states are implementing funds from the Rural Health Transformation Program, which will distribute $50 billion to rural providers from fiscal year 2026 to FY 2030. The report covers the period from Dec. 29, 2025, to July 31, 2026. The report details how much each state has allocated for the first year of the program, which would be spent by September 2027.”
  • Over the past week, CMS has issued news releases about contributions to the following State rural health programs:
  • Per Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS) today launched the Newborn Essentials Support Toolkit (NEST) Program at West Virginia University Medicine Golisano Children’s Hospital in Morgantown, West Virginia, marking the next phase of a federal initiative designed to support mothers and babies during the critical first days and weeks after birth.
    • “Led by HHS through the Office of Intergovernmental and External Affairs (IEA) in coordination with the Health Resources and Services Administration (HRSA), NEST provides families with a one-time kit of essential newborn and postpartum supplies, maternal health items, and trusted information and resources around the time of birth.” * * *
    • “NEST Kits are distributed through hospitals, federally qualified health centers, and other organizations providing maternity care to mothers late in pregnancy or around the time of birth. Through these trusted partners, HHS is working to reach families in communities across the country while prioritizing areas where mothers and babies face greater barriers to care and resources.
    • “Through NEST, HHS is building on what families and healthcare providers said worked: providing useful, high-quality supplies at a moment when families need them most, while connecting mothers with trusted information to help care for themselves and their newborns.
    • “For more information, visit hhs.gov/newbaby.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), today announced the recipients of three falls prevention initiatives totaling up to $27.8 million over three years. The funding will expand proven programs, strengthen connections between health care providers and community organizations, and help states and local partners reach more older adults before a fall leads to injury or loss of independence.
    • “Falls are the leading cause of injury for people 65 and older. One in four older adults falls every year, and a fall is rarely just a fall. It can result in an injury or hospital stay, and non-fatal falls account for an estimated $80 billion in healthcare spending per year. A fall can also shake a person’s confidence and make everyday activities — from walking and shopping to visiting friends — more difficult. Healthcare and aging network providers can help prevent many falls by identifying risks early. They can then connect older adults with programs and support that build strength, improve balance, and make their homes safer.
    • “The three initiatives put prevention first and advance the Trump Administration’s Make America Healthy Again agenda. They will connect screening with community support, expand proven programs statewide, and help organizations deliver and sustain them.” * * *
    • “Learn more about ACL’s Falls Prevention Program here.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) provided a new recommendation to the Drug Enforcement Administration (DEA) that establishes science-based thresholds for 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI), potent opioid compounds associated with products marketed as kratom.
    • “The Department of Justice today announced that DEA issued new Notices of Intent reflecting HHS’ updated scientific analysis and recommendations, including a new Notice of Intent for 7-OH and MGPI incorporating HHS’ recommended concentration and ratio thresholds.
    • Following a review of available scientific data and comments, HHS Assistant Secretary for Health Admiral Brian Christine, M.D., recommended that DEA use concentration or ratio-based thresholds to determine which products containing 7-OH and MGPI are subject to Schedule I control for purposes of temporary scheduling of these substances under the Controlled Substances Act.
    • “The recommendation is designed to target concentrated or chemically altered products while distinguishing them from natural botanical kratom products, which may contain trace amounts of 7-OH and MGPI.”
  • Beckers Clinical Leadership adds,
    • “The National Institutes of Health plans to launch a public-private partnership in December to speed development of personalized cancer vaccines, according to an Oct. 9 New York Times report.”
  • NCQA, writing in LinkedIn, tells us,
    • “At the opening of the 2026 Health Innovation Summit in Atlanta, NCQA President and CEO Dr. Vivek Garg, MD, MBA reflected on his first year leading the organization, honored the legacy of healthcare quality pioneers and invited attendees to help shape what comes next. Addressing a room filled with health plans, clinicians, policymakers, researchers, employers, technology leaders and patient advocates, he framed the Summit theme, Quality’s Next Chapter, as both a moment of reflection and a call to action.
    • “A year ago, many of you met me for the first time on this stage, when Peggy O’Kane handed off an organization she spent more than three decades building,” Dr. Garg said. “I’ve spent the year since mostly listening.”
    • That year of listening, he said, clarified NCQA’s mission and reinforced a central belief: “we cannot write quality’s next chapter alone.”

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

  • Bloomberg Law reports,
    • “Food manufacturers can now use salt substitutes in common foods including bread, canned peas, and sour cream under a federal rule regulators updated in an effort to reduce Americans’ sodium intake.
    • “A final rule published Friday in the Federal Register under public inspection loosens requirements that certain foods contain salt under the Food and Drug Administration’s standards of identity, which regulate what a product must contain to be marketed as a specific food.
    • “The regulatory update allowing food makers to use salt substitutes actualizes a proposal from the Biden administration to improve consumers’ diets, as officials raised concern that the average American consumes a level of sodium that’s 50% above the limit recommended by scientists.” 
  • Reuters relates,
    • “Teva (TEVA.TA), opens new tab ​said on Friday it had received approval ‌from the US Food and Drug Administration for Weltruza, a once-monthly injection for adults with ​schizophrenia.
    • “Weltruza is the second US-approved product ​from Israel-based Teva’s partnership with French ⁠biotech company Medincell (MEDCL.PA), opens new tab after Uzedy, a long-acting ​injectable form of antipsychotic drug risperidone, which ​the FDA approved in 2023.”
  • Medical Life Sciences News tells us,
    • “The Alliance for Clinical Trials in Oncology (Alliance) today announced that the U.S. Food and Drug Administration has approved the immunotherapy drug atezolizumab (Tecentriq®) in combination with fluoropyrimidine and oxaliplatin chemotherapy, for the adjuvant treatment of patients with stage III colon cancer with deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR).
    • “The approval is based on findings from the phase III Alliance ATOMIC (A021502) trial, sponsored by the National Cancer Institute (NCI) and conducted in partnership with Genentech, a member of the Roche Group, and the German group Arbeitsgemeinschaft Internistische Onkologie (AIO). The study demonstrated that patients with stage III colon cancer whose tumors had mismatch repair deficiency (dMMR) experienced significantly improved disease-free survival, a surrogate for overall survival, when atezolizumab was added to standard adjuvant chemotherapy following surgery.”
  • Healio adds,
    • “Medicare coverage is now available for the Fsyx ocular pressure adjusting pump, a device indicated to lower IOP in patients with glaucoma while they are sleeping.
    • “The device consists of pressure-sensing goggles connected to a compact pump that counteracts IOP overnight using negative pressure. CMS reimbursement for the Fsyx ocular pressure adjusting pump (Balance Ophthalmics) became effective on Oct. 1.”

From the Medicare Advantage front,

  • Healthcare Dive reports,
    • “Medicare Advantage star ratings are slipping in 2027, though one major insurer clinched an extreme upgrade.
    • “Humana, which suffered a major ratings collapse two years ago, saw the percentage of its members in 4+ star plans rocket from 41% in 2026 to 93% in 2027, according to a Healthcare Dive analysis of stars data released Thursday by the CMS.” * * *
    • “Alignment Healthcare, which covers some 280,000 members in five states, was one of the biggest losers, after its largest contract slipped below 4 stars for 2027.
    • “It’s a serious setback for the California-based insurer, given the contract covers around three-fourths of its total membership. Next year, Alignment will only have 25% of members in plans rated above that threshold, down from 98% currently.”
  • Beckers Payer Issues delves into Humana’s star rating turnaround.

From the judicial front

  • The American Hospital Association News reports,
    • “The AHA, the Maine Hospital Association and four safety-net hospitals Oct. 9 filed a lawsuit in the U.S. District Court for the District of Maine challenging changes by the Department of Health and Human Services to the 340B Drug Pricing Program that would expand the use of a proposed rebate model previously halted by the courts.  
    • The lawsuit seeks to prevent implementation of the new program, which is scheduled to take effect on Jan. 1, 2027. The rebate program would impose significant new financial and administrative burdens on hospitals that participate in the 340B program. Estimates show the new program could impose more than $1 billion in annual administrative costs on already-strapped hospitals. 
    • “When the government makes a change of this magnitude, it must fully consider what it will mean for the patients and communities that rely on 340B hospitals every day,” said Steve Walsh, president and CEO of the AHA. “The AHA and its member hospitals provided detailed evidence showing that the Rebate Program would impose massive new costs and divert resources that support care for millions of patients. We also proposed viable alternatives that would address concerns about transparency and program integrity without imposing the same financial price tag. For the sake of our shared goal of protecting patients and expanding access to care, those costs, consequences and alternatives cannot be treated as afterthoughts. It’s unfortunate that we are back in court challenging the same flawed program.” 
    • “Following HHS’ attempt to launch a similar rebate program in 2025, both the U.S. District Court for the District of Maine and the 1st U.S. Circuit Court of Appeals faulted HHS for moving forward with a rebate mechanism without adequately accounting for what it would cost the hospitals required to operate it. Shortly thereafter, HHS moved forward with a revised version of the same Rebate Program — only twice as large and even more expensive. 
    • “The AHA and Maine Hospital Association are joined in this action by Eastern Maine Medical Center, Unity Medical Center in North Dakota, Dallas County Medical Center in Arkansas, and Nathan Littauer Hospital and Nursing Home in New York — all community-based healthcare providers that participate in the 340B program.  
    • “See the press release for more details.  

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.
    • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
  • The American Hospital Association News adds,
    • “There are now 1,136 confirmed measles cases in Pennsylvania this year amid the state’s outbreak, the Pennsylvania Department of Health announced Oct. 9. Of those, 219 individuals have been hospitalized and five people have died. Nationally, there have been 4,080 confirmed cases of measles this year, according to the latest update by the Centers for Disease Control and Prevention. Of those, the vaccination status of 95% of cases is unvaccinated or unknown.”
  • and
    • “A study by the University of Minnesota Rural Health Research Center found that between 2007 and 2023, the percentage of midwife-attended births rose in both rural and urban settings and was higher in states that had full midwifery practice authority policies. The study, supported by the Federal Office of Rural Health Policy, used data from the Centers for Disease Control and Prevention and the American College of Nurse-Midwives. In 2007, 13 states and Washington, D.C., had full practice authority policies. From 2008 to 2023, 20 more states passed such policies. Overall, there was growth during the study period among states without full practice authority policies, states that passed policies in 2007 or earlier, and states that passed policies during the study period.”
  • Beckers Clinical Leadership breaks down the measles cases by State and tells us,
    • “Flu season is arriving weeks earlier than usual this year, with health system, retail pharmacy and federal surveillance data all showing activity rising ahead of schedule.”
  • Health Day informs us,
    • “HPV vaccination may reduce pregnancy complications.
    • “Women vaccinated against HPV had lower risks of preterm birth, early rupture of the amniotic sac and having a very small baby.
    • “Women vaccinated before age 17 showed stronger benefits.”
  • and
    • “Exercise might help slow the mental and physical problems associated with Parkinson’s disease.
    • “Patients who got the most exercise had slower declines in movement, thinking and memory.
    • “More than eight hours of physical activity weekly produced the greatest benefits.
  • and
    • “Among patients with cancer with a genetic variant that increases the risk for hereditary cancers, personalized support significantly increases the likelihood that their first-degree relatives complete genetic testing as well, according to a study published online Sept. 29 in the Journal of Clinical Oncology.”
  • Per NewsNation,
    • “The American Society of Hematology (ASH) has adjusted the standards for diagnosing iron deficiency in order to address the underdiagnosis of the condition.
    • “Iron deficiency impacts about two billion people worldwide and about 10 million American adults, according to a statement published by ASH. If left untreated, the condition can progress to iron deficiency anemia. One of the most common types of anemia. 
    • “It occurs when there’s a lack of iron in the blood, preventing the body from making hemoglobin. This is the molecule that carries oxygen throughout your body, according to the Cleveland Clinic.“
  • Medical Economics notes,
    • “Adding a brief safety reminder to the instructions given to artificial intelligence (AI) models reduced potentially harmful clinical choices in 19 of 20 models tested, according to a new study from researchers at the Icahn School of Medicine at Mount Sinai.
    • “The study, published September 26 in Communications Medicine, a Nature Portfolio journal, evaluated more than 10 million responses from 20 large language models (LLMs). Without a safety reminder, potentially harmful choices made up 16.6% of model responses. With a brief reminder added, that rate fell to 10.1%.
    • “Across all responses, the models made about 1.18 million potentially harmful clinical choices, the researchers reported.
    • “The researchers said the findings suggest that how AI systems are prompted and guided remains an important consideration in building safe and reliable clinical applications, even as newer models and AI agents become better at understanding a user’s intent without lengthy or detailed instructions.”
  • The New York Times points out,
    • “Last year, nearly 100 people tried a new form of medical care at Beth Israel Deaconess Medical Center in Boston. After scheduling a visit with the hospital’s urgent care facility, they discussed their ailments with a Google chatbot before meeting with their doctors.
    • “The bot explored their symptoms, the possible causes of their maladies and the potential treatments, before generating a summary of each conversation. Doctors could then review the bot’s summary in preparation for a patient’s visit.
    • “These patients were part of an eight-month clinical trial that explored whether this specialized chatbot could assist primary care physicians without providing misleading or otherwise harmful information.
    • “In the first-of-its-kind study, published on Thursday in the medical journal The Lancet, the hospital’s primary care physicians said that the bot was helpful in about 75 percent of patient cases, and that the technology may have changed the way they handled more than half of those cases. “They compared it to a high-performing medical student or resident,” said Peter Brodeur, a resident physician at Beth Israel.”

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

  • Fierce Pharma reports,
    • “As GSK works on a nearly $1 billion expansion at one wing of its Pennsylvania operations, the U.K.-headquartered Big Pharma is unveiling a similarly sized outlay to soup up another site across the state. 
    • “All told, GSK is plugging more than $800 million into an overhaul of its facilities in Upper Merion Township, where construction is slated to kick off next year, according to an Oct. 9 release from the office of Pennsylvania Governor Josh Shapiro. 
    • “The goal is to set up a biopharma “innovation and manufacturing hub,” per the Governor’s release, which will ultimately wed commercial production and R&D activities at a single site with the aid of digital technologies.”
  • and
    • “Prescriptions for Lilly’s Foundayo and Novo’s Wegovy pill pulled back a little during the last week. In its 26th week of launch, Foundayo achieved 57,920 total scripts, down 9.9% sequentially, according to IQVIA data cited by Citi. 
    • “For oral Wegovy, Citi said IQVIA recorded roughly 179K scripts, while Jefferies quoted 180K. To reconcile the discrepancy between the two numbers, we used 179.5K, which translates into a 1.4% weekly decline.
    • “In fact, scripts for all major GLP-1s declined last week across diabetes and obesity care, save for Lilly’s Zepbound KwikPen, a prefilled injection pen that delivers four fixed weekly doses of tirzepatide, according to Jefferies. Overall Zepbound scripts dipped below 800K in a 0.8% decrease sequentially, just as Novo’s total Wegovy scripts fell 2.7% to 505.5K, according to Citi.
    • “Based on the numbers, Jefferies now models $208 million for Foundayo sales in the third quarter, which the team noted is in line with consensus.” 
  • Beckers Payer Issues relates,
    • “Fortune recognized five healthcare companies on its 2026 “AIQ 75” ranking.
    • “Fortune partnered with Enterprise Technology Research and pulled from ServiceNow’s Enterprise AI Maturity Index. The team assessed how Fortune 500 companies, the largest U.S. companies by revenue, deploy AI and value those investments. Fortune released its first inaugural AIQ ranking in 2025.” * * *
      Here is where the five healthcare companies landed:
      • 30. UnitedHealth Group (No. 3 on Fortune 500)
      • 31. Elevance Health (No. 18 on Fortune 500)
      • 36. DaVita (No. 331 on Fortune 500)
      • 48. Pfizer (No. 73 on Fortune 500)
      • 75. Thermo Fisher Scientific (No. 106 on Fortune 500)
  • and
    • “The Blue Cross Blue Shield Association is bringing its data and analytics work “under one internal umbrella,” the organization confirmed to Becker’s Oct. 9.
    • “The former CEO of Blue Health Intelligence, an analytics company that has been a BCBSA licensee, said he wrapped up his work with the association in September after “supporting the integration of Blue Health Intelligence back into BCBSA.”
    • “I’m excited about the opportunity for the combined team to have an even greater impact on healthcare quality and affordability,” former BHI CEO Bob Darin said in an Oct. 8 LinkedIn post.
    • “A BCBSA spokesperson said the integration will help the association “better leverage data-driven insights to identify how we can lower costs, reduce friction and improve the healthcare experience for patients, employers and providers.”
  • Beckers Hospital Review tells us,
    • “Revised federal price transparency rules have made hospital price data clearer, but several issues still complicate price comparisons, according to an Oct. 7 analysis from the Peterson-KFF Health System Tracker.
    • “The revisions to the 2021 hospital price transparency rule took effect in January, and CMS began enforcing them in April. Hospitals must now post a negotiated rate as a dollar amount whenever the final payment can be known before care is delivered. When a rate is a percentage or a formula, hospitals must also report “allowed amount” data: the median, the 10th and 90th percentile payment amounts, and the number of payments.
    • “The researchers reviewed machine-readable files compiled by Turquoise Health and downloaded between July 17 and Aug. 2. They examined two common inpatient admission codes, MS-DRGs 280 and 807, in several local markets and reviewed national patterns across 6,445 hospitals.
    • “These complications reflect the complexity of payment arrangements between hospitals and payers,” the report stated.”
  • and
    • “Fifty-seven hospitals across 22 states have converted to rural emergency facilities since the law that created the designation took effect in January 2023, according to data from CMS.
    • [The article identifies] the hospitals that have converted to rural emergency status, by state.
  • and
    • “A $75,000 donation from Covenant Presbyterian Church in Austin, Texas, has helped erase $14 million in medical debt for 10,865 residents through a partnership with nonprofit Undue Medical Debt, The Austin American-Statesman reported Oct. 9.
    • “The church used part of a $200,000 budget surplus to fund the relief, targeting residents in an area of Travis County with significant financial need, according to the report. Recipients are being notified by mail the week of Oct. 9 and do not need to take any action to receive the relief.”
  • Beckers ASC Review points out,
    • “Cardiology is shaping up to be the next big ASC specialty, following the path GI took in the 1990s and orthopedics in the 2010s. Medicare’s 2026 decision to pay for cardiac ablation in ASCs, a proposed 2027 rule that keeps widening the door and payer pressure on site-of-care have pushed cath and EP labs onto ASC leaders’ agendas.”
  • Beckers Physician Leadership notes,
    • “Health systems want physicians to be more productive, and physicians want to be paid fairly for the work they do. 
    • “Somewhere between those two goals, many compensation models break down — either rewarding volume at the expense of everything else or offering so much guaranteed pay that productivity has no meaning.
    • “Westchester Medical Center Health Network, based in Valhalla, N.Y., is working through that tension now. The system is building a new physician compensation structure as it expands its medical group, which includes roughly 1,100 to 1,200 academic and community practitioners, and shifts from an inpatient-centric mix close to 80/20 toward something nearer 50/50 or 60/40 ambulatory.” * * *
    • “The risk in any productivity-based model, Dr. Tedjarati said that physicians start to feel like a cog in a machine. The structure has to signal that the organization still values them for who they are and what they bring, and that they remain part of a larger mission. Because institutions are constantly competing for the same physicians, he said, getting that balance wrong carries a real cost.
    • “It’s really about agility. It’s about agility and creating comp models that people can understand,” he said.
    • “When those pieces are in place, Dr. Tedjarati said, the incentive structure becomes something physicians can see themselves succeeding in rather than something imposed on them.
    • “I think people do well when they know where they’re starting and where they’re going to, and that if they happen to be more productive and more efficient, maintaining the quality that is required, then they should be appropriately rewarded and compensated,” he said.”

Thursday report

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

Simplicity is a virtue

From Washington, DC

  • The Wall Street Journal reports,
    • “Newly installed Centers for Disease Control and Prevention Director Dr. Erica Schwartz said she wants to change a culture of “paternalism” at her agency.
    • “Americans need to be better informed about how and why the CDC makes its recommendations, and the agency needs to be willing to listen to people’s concerns, she said. 
    • “There is a sense of paternalism that we have had at the CDC,” Schwartz said. “It shouldn’t be this black box that we say, ‘Verily thou shalt, and then that’s the answer.’”
    • Schwartz made the comments Wednesday at a Wall Street Journal Future of Health event in Washington, D.C.
    • “Schwartz said Wednesday that parents should prioritize receiving measles vaccines for their children amid current U.S. outbreaks, saying the shot is “absolutely safe, absolutely effective.” She defended the secretary, a skeptic of vaccines who has said they are a “personal decision,” saying he channels concerns from parents who are wary of the full slate of childhood immunizations.
    • “The secretary does represent the voices of a number of Americans who are asking questions about certain vaccines,” she said, adding that doctors shouldn’t approach vaccine-skeptical parents with “a paternalistic way of thinking.”
  • Casey B. Mulligan, HHS chief economist and chief regulatory officer, writes in STAT News,
    • “Some Medicare patients owe more in coinsurance than the hospital paid for their drug. That arithmetic sounds impossible. It is a consequence of the 340B drug discount program and Medicare’s payment formula. Now the Department of Health and Human Services, where I work, is proposing to narrow that gap.
    • “Congress created the 340B drug discount program in 1992 to financially support safety net hospitals that serve low-income patients. Drug manufacturers must give them steep discounts. But Medicare, Medicaid, and commercial insurers generally reimburse them at the full amount, allowing these hospitals to keep the spread above the discounted purchasing costs.
    • “A new report from the Department of Health and Human Services shows other unintended consequences of this well-intended program. The spread grows with the price of the drug. It therefore rewards hospitals for using more and costlier drugs and makes physician practices and infusion clinics more valuable after a 340B hospital acquires them. The patient’s treatment needn’t change. The owner and billing site do.” * * *
    • “On April 18, 2025, President Trump directed HHS to obtain the cost information the statute requires. CMS surveyed hospitals from January through April 2026 and has proposed paying for affected 340B drugs at ASP minus 33.4% in 2027. CMS estimates that Medicare drug payments would fall by $4.55 billion in the first year and beneficiary drug copayments by $1.15 billion.
    • “For a drug with an ASP of $1,000, a beneficiary’s standard 20% coinsurance would fall from $212 to $133.20. The prescription hasn’t changed. The patient’s share of the hospital’s bill has. Narrowing the spread also weakens the incentive to steer patients toward costlier drugs and to acquire physician practices and infusion clinics — the very behaviors that have made care more expensive.” * * *
    • “Medicare patients should not pay coinsurance as though the discount did not exist.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) this week launched a series of actions to strengthen how the federal government identifies, documents, investigates, and responds to health problems reported following vaccination, with a focus on improving patient care and generating better evidence about potential vaccine-related injuries.
    • “To address health problems Americans report after vaccinations, HHS:
      • Opened a new National Institutes of Health (NIH) clinic dedicated to studying and caring for patients experiencing health problems following vaccination;
      • Proposed reimbursing physicians for reporting suspected vaccine-related injuries to the Vaccine Adverse Event Reporting System (VAERS) through a new Centers for Medicare & Medicaid Services (CMS) policy, bringing vaccine reporting in Medicare in line with typical Medicare reimbursement policies;
      • Will require electronic health records to capture vaccine-related adverse events so that information can follow patients across the health care system; and
      • Is modernizing the Centers for Disease Control and Prevention’s (CDC) VAERS to make reporting simpler and improve the tools available to researchers and medical professionals investigating potential safety signals.
    • “We must listen to patients and families who report vaccine injuries—not dismiss or gaslight them,” said HHS Secretary Robert F. Kennedy, Jr. “President Trump and I are building a health system that takes them seriously, follows the evidence, and uses what we learn to make vaccines safer. This is how we earn back trust in our public health institutions.”
  • Beckers Hospital Review informs us,
    • “The Trump administration is preparing a stopgap that would allow certain previously restricted peptides to be sold temporarily while federal health officials write new regulations, according to an Oct. 7 Washington Post report citing two people familiar with the matter.
    • “The move would let some compounding pharmacies dispense peptides marketed as medical treatments and wellness products, even though the claims for what they treat have not been fully safety tested. The plan has not been announced, and the Post reported that its timing is unclear, it could still change and it is not known which peptides would be included. The sources said federal officials are seeking guardrails around the policy, and HHS did not comment.
    • “The FDA has been weighing whether to let compounding pharmacies produce seven peptides for conditions such as insomnia, obesity and wound healing. FDA scientists said there is not enough evidence on their safety and effectiveness, but the agency’s Pharmacy Compounding Advisory Committee, which was reshaped with wellness clinic physicians before the meeting, voted in July to recommend six of the seven. It voted against emideltide, a proposed treatment for opioid withdrawal and insomnia.
    • “The FDA is not required to follow the panel’s advice, and the Post said it is not clear when formal rulemaking will be released. Safety groups ECRI and ISMP warned after the vote that gaps in safety and efficacy data remain unresolved.”
  • The American Hospital Association News points out,
    • “The Department of Homeland Security Oct. 8 issued a proposed rule that would establish new fees for foreign students seeking Optional Practical Training, a program that allows F-1 students to work in the U.S. in positions related to their field of study after graduation. Specifically, DHS proposes a fee of $70,000 for an initial OPT authorization and $30,000 for any subsequent OPT authorization, citing concerns about fraud, program integrity and protection of U.S. workers. The agency is accepting comments through Nov. 9.
    • “The proposal could have significant implications for hospitals and health systems that rely on international graduates, including nurses, physicians, pharmacists and other healthcare professionals, as OPT often serves as a pathway into the healthcare workforce. The AHA will review the proposed rule and evaluate its potential impact on workforce recruitment and retention.”
  • and
    • “The Agency for Healthcare Research and Quality Oct. 7 announced the launch of the Super Intelligence for Healthcare Improvement Initiative, a two-part artificial intelligence competition focusing on medical evidence reviews and data. The first competition, called the Clinical Evidence Synthesis Transformation Challenge, aims to reduce analysis times from a year or longer to hours. This competition consists of two phases, where up to five finalists will receive $100,000 each after the first, and one winner will receive $5.35 million following the second. The challenge submission period will run from Jan. 11 to March 12, 2027.
    • “The next part of the initiative, called the SI Tech Sprint for Healthcare Research and Implementation Quality and Safety, aims to use AI to leverage AHRQ’s cost, utilization and quality databases to establish an AI-enabled ecosystem of applications for research, quality improvement and public access. The total prize pool is $2.1 million for selected winners. Submissions will be accepted from March 1 to Sept. 9, 2027. AHRQ’s webpage for the competition provides additional details, including information on registration, resources and an FAQ.”

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

  • FedWeek reports,
    • “Federal employees who have been watching the government’s renewed focus on reductions in force (RIFs) should pay close attention to one development in particular: newly finalized changes that make performance ratings far more important in determining who stays and who goes.
    • “These regulations are now final law and apply to any agency issuing a specific RIF notice on or after September 2, 2026. As a result, many employees will find that their last several performance appraisals carry greater weight in whether they keep their jobs. That means the time to review your record is now, not after an RIF notice arrives.
    • “This article is not legal advice for any individual employee. But it outlines practical steps federal employees can take now to protect their retention standing, preserve appeal rights, and avoid being caught flat-footed under OPM’s finalized RIF framework.”
  • Federal News Network relates,
    • “There’s a new way to look at data about the federal workforce. The Office of Personnel Management has launched an AI chatbot to answer the public’s questions about workforce trends. The new feature has been added to OPM’s “federal workforce data” website, which details employment numbers and other information about the civil service. Users can enter questions and get AI-generated answers about government hires and separations, as well as workforce demographics like age, veteran status and education level. — Drew Friedman(FWD Chat – Office of Personnel Management)”
  • Edward Zurndorfer, writing in My Federal Retirement, discusses “The Biggest Medicare Mistakes That Can Cost Federal Retirees.”
  • Tammy Flanagan, writing in Govexec, advises “Don’t let 5% become your TSP retirement strategy.”
    • “Getting the full agency match is a good baseline, but if retirement is around the corner there’s more to consider before deciding what to do with the rest of your paycheck.”

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

  • NBC News reports,
    • “The Food and Drug Administration expects to complete its safety review of the abortion pill mifepristone in March, according to a court document the Justice Department filed Wednesday.
    • “In the filing, the FDA said it plans to compare mifepristone’s safety to that of surgical abortions through 10 weeks’ gestation. Its review will measure the frequency of side effects among roughly 100,000 women who took mifepristone, it said. 
    • “Results of the FDA’s review are expected in mid-December. From there, the agency will analyze the data and draft a final report — a process it expects to wrap up in March.” * * *
    • “The update Wednesday is in response to an order by a federal judge in Louisiana for a progress report on the safety review.
    • “The FDA is a defendant in a Louisiana suit challenging its telehealth provision, which has largely been responsible for preserving nationwide access to abortion since the Supreme Court overturned Roe v. Wade in 2022. Louisiana filed the case on behalf of a woman who said her boyfriend had ordered abortion pills and forced her to take them.
    • “In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person. But the Supreme Court quickly blocked the decision while the case plays out.”
  • Food Safety relates,
    • “The U.S. Food and Drug Administration (FDA) has issued a draft guidance that, if finalized, will provide enforcement discretion from the requirements of the Food Traceability Rule, also known as Section 204(d) of the Food Safety Modernization Act (FSMA 204),  for certain smaller retail food establishments (RFEs) and restaurants that were not previously captured as part of the full exemption for small RFEs and restaurants offered as part of the rule. 
    • “FDA said it believes “this additional flexibility will maintain the intended public health benefits of the rule, as it would only impact a small percentage of total food sales, while also providing relief to numerous smaller RFEs and restaurants.”
  • MedPage Today tells us,
    • “The FDA flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, Newron Pharmaceuticals said Thursday.
    • “The notice follows an announcement in April that the agency halted patient enrollment in the phase III ENIGMA-TRS 2 trial after the sudden death of a participant in an evenamide clinical trial. That hold remains in place at U.S. study centers but enrollment continues in other countries, and additional clinical sites are being added.
  • Cardiovascular Business informs us,
    • “Houston-based Leader Formulas is recalling one lot of its Rapture Preworkout dietary supplement due to the presence of 1,3-dimethylamylamine (DMMA), an ingredient not listed on the product label. 
    • “DMMA, often referred to as “geranium extract,” has been linked to a heightened risk of high blood pressure. It is also known to lead to certain cardiovascular problems, including heart attack, shortness of breath and chest pain. Its presence was first identified by the U.S. Food and Drug Administration (FDA) during a routine test. 
    • ‘This voluntary recall includes three different products—Rainbow Twist, Electric Lemonade and Berry Mojito—that were all part of lot 260327-4.
    • “Consumers who have purchased the Rapture Preworkout products which are being recalled should stop using the products and return to the place of purchase for a full refund,” according to Leader Formulas statement.”
  • Beckers Hospital Review adds,
    • “The FDA has flagged patient safety risks tied to nine products sold through Amazon that the agency said are unapproved new drugs marketed to treat sexually transmitted infections or their symptoms.
    • ‘The agency identified the violations after reviewing labeling for products it purchased from Amazon in July 2026, according to an Oct. 1 warning letter. The FDA said the products were introduced or delivered for introduction into interstate commerce by Amazon through its Fulfillment by Amazon service.
    • “The FDA said no OTC drug product has been approved for the treatment, cure, mitigation or prevention of any STI. The agency said effective treatment requires diagnosis and supervision by a licensed healthcare professional.” * * *
    • “Amazon was directed to respond within 15 business days of receiving the letter with steps taken to correct the violations and prevent their recurrence.”

From the Medicare Advantage front,

  • In a CMS fact sheet, CMS published 2027 Medicare Advantage and Part D Star Ratings.
    • “The information included in this Fact Sheet is based on the 2027 Medicare Advantage (MA) and Part D Star Ratings published on the Medicare Plan Finder on Oct. 8, 2026. For details on the methodology of the MA and Part D Star Ratings, please refer to the 2027 Part C & D Star Ratings Technical Notes available at http://go.cms.gov/partcanddstarratings.”

No Surprises Act News,

  • Bloomberg Law reports,
    • “Insurers and providers share common concerns about ineligible claims under a federal surprise billing law, bolstering Senate HELP Committee Chair Bill Cassidy’s push for a legislative fix before he leaves Congress, Erin Durkin and Victoria Knight report.
    • “The No Surprises Act, a 2020 statute designed to protect patients from unexpectedly large bills from emergency rooms and other out-of-network providers, established an arbitration process for payment disputes between providers and insurers. A flood of ineligible claims is clogging that process — and closed-door meetings convened by Cassidy have put the issue on the table as a shared concern
    • “Cassidy says he’d like to put out legislation before he departs the Senate at the end of the year. While time is running short, the veteran legislator signaled the issue is gaining traction.
    • “Believe it or not, there’s common ground there,” Cassidy said.”
  • STAT News adds,
    • “A new proposal in Congress to scrap a surprise billing ban’s controversial arbitration system will need to to survive an onslaught of attacks from provider groups, for whom arbitration has been a gold mine.
    • “After Rep. Frank Pallone (D-.N.J.) unveiled his Lower Premiums, Faster Payments Act on Thursday, it quickly garnered praise from academics and consumer advocates, as well as condemnation from provider groups. It would dismantle the problem-plagued process that’s currently used to resolve disputes between health insurers and out-of-network providers and replace it with a payment system based on median in-network rates.”
  •  FEHBlog observation — Good luck, Rep. Pallone.

From the fraud, waste and abuse front,

  • NextGov reports,
    • “The Centers for Medicare and Medicaid Services is exploring a new contract operating model and technologies so that the agency can more effectively prevent fraud, instead of chasing after money already in the hands of bad actors, according to documents posted on SAM.gov Monday.
    • “CMS has traditionally contracted with private companies to boost its investigative capabilities and support administrative actions, such as imposing payment suspensions, according to the listing. But under a draft operating model, CMS wants to take a greater role in leading the development, prioritization and direction of those investigations, the website adds.
    • “The old model “worked in the past but new technology and new techniques mean it is time to see if it still works as well,” Kimberly Brandt, a CMS Deputy Administrator, posted on LinkedIn.
    • “Under the draft model, CMS would assign fraud investigations to contractors whose primary role is to develop the investigation and administrative actions under the agency’s oversight, according to a draft Statement of Objectives posted on SAM.gov.”
  • Per a Justice Department news release,
    • “Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division (the Fraud Division) today released Directive 26-13, outlining the Division’s comprehensive approach in the fight against fraud.
    • “Expanding on earlier guidance regarding the Division’s priorities (available here) and corporate enforcement policy (available here), Directive 26-13 sets out the Division’s prosecutorial methodology for investigating, disrupting, and prosecuting fraud. This directive marks a significant operational shift, requiring the Division’s prosecutors to attack fraud from all angles using the Division’s tax, securities fraud, consumer fraud, and cybercrime authorities.
    • ‘This directive also requires Division prosecutors to deploy early, pre‑indictment asset seizures and digital‑infrastructure takedowns to halt fraud schemes and freeze assets in real time. Finally, this directive urges Division prosecutors to develop practice cooperators, zealously prosecute corporate bad actors, seek arrest and detention in appropriate cases, and deliver fulsome advocacy at sentencing. This new, comprehensive approach will drive the Division forward in its mission to preempt, disrupt, and dismantle fraudulent networks before they can inflict widespread harm.
    • “Read the full memo here.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Taylor Farms, the produce giant linked to last summer’s deadly cyclospora outbreak, is suspending sales of iceberg lettuce from central Mexico during the parasite’s peak season. 
    • “Chief Executive Bruce Taylor said the company won’t sell iceberg lettuce in the U.S. or Canada that was harvested or processed in the region between May 1 and Aug. 31, starting next year. The period covers central Mexico’s rainy season, Taylor said, and it matches the time when the Centers for Disease Control and Prevention sees an increase in illnesses caused by the cyclospora parasite. 
    • “The company hasn’t determined when the suspension will be lifted.”
  • Reuters relates,
    • “Centers for Disease Control and Prevention Director ​Erica Schwartz said on Wednesday the risk to the US ‌from an unconfirmed pneumonic plague case in Siberia was extremely low, but the agency was prepared to monitor and screen travelers.
    • “We are working with Department of Homeland Security, ​working (with) Department of State, Department of War, and other agencies within ​the government to make sure that we know exactly if ⁠anyone from that area comes into the United States,” Schwartz said at ​the Wall Street Journal’s The Future of Health event in Washington.”
  • and
    • “Using artificial intelligence, researchers may have found a way to make vaccines based ‌on mRNA technology, such as Moderna’s (MRNA.O) and Pfizer’s (PFE.N) COVID shots, storable at room temperature, which would lower costs and make them available in regions where ultra-cold storage is not possible.”
  • and
    • “AI may improve doctors’ ability to detect heart transplant rejection without surgery and appeared to be more accurate than standard blood tests, according to a report in Journal of Heart and Lung Transplantation.”
  • Fierce Healthcare adds,
    • “Utah is expanding the state’s AI regulatory sandbox program with new pilots to test AI-supported prescription renewals, dermatology and physical therapy, while stepping up physician oversight and adding independent third-party evaluators.
    • “Utah is bringing the Utah Department of Health and Human Services, Intermountain Health, University of Utah Health, medical licensing officials and outside experts into the state’s AI policy process. State officials and health systems leaders say the initiative is designed to test AI in real-world clinical settings, generate evidence on its benefits and risks and address key questions around liability, privacy and regulation.”
  • The Washington Post tells us,
    • “Brandon Luu began thinking about the body’s circadian machinery as a teenager, when he was routinely unable to fall asleep until late, sometimes well past 2 a.m. The schedule made mornings miserable and school harder.
    • “But it also left him with a question: What happens when the body’s sense of time falls out of sync with the world around it?
    • “Fifteen years later, Luu is exploring that question through one of psychiatry’s most common disorders: attention-deficit/hyperactivity disorder (ADHD). Sleep problems have long been seen as a consequence of the condition. But now researchers are looking at the possibility that the relationship might run in reverse: that disruptions to circadian rhythms — the biological machinery governing when we sleep and wake — might be a cause.”
  • MedPage Today notes,
    • “Adults with ADHD had substantially higher risks of mild cognitive impairment or dementia.
    • “Genetic ADHD risk predicted cognitive impairment, supporting an association beyond clinical diagnoses.
    • “Findings do not prove a causal link; treatment effects and other variables require further study.”
  • Beckers Clinical Leadership informs us,
    • “Suicide became the 10th-leading cause of death in the U.S. in 2024, up from No. 11 in 2023, according to final mortality data from the CDC’s National Center for Health Statistics. Suicide deaths fell 1% over the same period, from 49,316 in 2023 to 48,824 in 2024, and accounted for 1.6% of all deaths in both years. Suicide’s move into the top 10 happened as COVID-19 deaths declined 37%, dropping COVID-19 from 10th to 15th.
    • “Recent data show patterns that differ by method, age and geography. Gun suicides reached record levels for a fifth straight year even as the overall suicide rate trended down. Emergency department visits for suspected suicide attempts declined among adolescents but rose among adults 26 and older. In 2025, rates ranged from 5.3 per 100,000 in the District of Columbia to 31 in Alaska. At the same time, researchers, children’s hospitals and states are pursuing a range of prevention approaches, from smartphone-based risk forecasting and universal ED screening to firearm access laws.
    • [The article notes] seven things to know about the state of suicide in the U.S.
  • The National Cancer Institute points out,
    • “Mutations in a family of genes called RAS, and the rogue proteins they produce, help drive roughly a third of all cancers, including more than 90% of pancreatic cancers. Yet RAS has long been one of the most elusive drug targets in cancer research. Unlike other proteins targeted by cancer drugs, RAS proteins have relatively smooth surfaces, with no obvious place for a drug molecule to bind. That made RAS notoriously “undruggable.” 
    • “Despite the long odds, federally funded research continued to push the field forward. Researchers eventually revealed the structure of RAS proteins and how they function, and those insights led to new approaches for blocking mutant RAS, particularly KRAS, which is involved in the vast majority of RAS-driven cancers.
    • “Today, three RAS inhibitors—sotorasib (Lumakras), adagrasib (Krazati), and, most recently, daraxonrasib (Rasonque)—are helping patients live longer, and many additional molecules that block mutant RAS are moving through the research pipeline.”
    • “These life-changing drugs would not have been possible without the sustained public investments that laid the groundwork for the field, said Harold E. Varmus, M.D., former Director of the National Cancer Institute (NCI) and the National Institutes of Health, who launched NCI’s RAS Initiative.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Hospitals continue to shift care to outpatient settings, according to a new analysis of data from the first half of the year by Strata Decision Technology.
    • “As a result, hospitals are seeing sicker patients in their inpatient wards as they send lower-acuity patients to outpatient departments. 
    • “Patients in some service lines, like gynecology, had procedures done less in hospitals as minimally invasive surgery options in outpatient settings grew. However, other service lines like breast health saw more, sicker patients in the hospital, likely due to an increase in breast cancer testing and diagnoses, according to the data.”
  • Beckers Hospital Review relates
    • “In early January, Tamar Goldblatt was named vice president of payer revenue strategy and contracting at St. Louis-based Ascension. 
    • “Since then, Ms. Goldblatt has worked closely with system and ministry leaders to understand the distinct needs of each market and align them with Ascension’s broader payer strategy. Her work comes at a time where Medicare Advantage instability, rising denial rates and growing administrative burden have turned once-routine payer discussions into high-stakes negotiations. 
    • “Becker’s connected with Ms. Goldblatt to discuss her top priorities nearly one year into the role, the trends that are reshaping payer partnerships and how she approaches payer collaboration.”
  • and
    • “CVS Health unveiled its first pharmacy-focused CVS Pharmacy in the Boston area Oct. 7. The site is meant to expand access to medications, immunizations and other pharmacist-provided services in the community.
    • “Nearly 20 pharmacy-focused locations will open in select communities across the country in 2026. The sites average about 3,000 square feet and include a full-service pharmacy with a limited selection of over-the-counter products.
    • “CVS has already opened pharmacy-focused locations in Birmingham, Ala., Chicago, Detroit, Houston and Washington, D.C. The company also plans to open more than 40 new CVS Pharmacy locations this year, including traditional stores and pharmacies inside Target stores. CVS cited its 2025 Rx Report, which found 80% of patients prefer face-to-face pharmacy care and 48% would switch pharmacies if limited to digital-only options.”
  • The Wall Street Journal tells us,
    • “Viatris VTRS has agreed to buy pain-drug maker Pacira BioSciences PCRX for $1.65 billion in a deal that expands the healthcare company’s medicines portfolio.
    • “Viatris on Thursday said it would pay $36.50 a share in cash for Pacira, a roughly 45% premium to Wednesday’s closing price of $25.20 for the Brisbane, Calif., company.
    • “The deal is slated to close by the end of the year.
    • “Shares of Pacira were recently up 44% at $36.33 in premarket trading, while shares of Viatris edged down 0.1% to $17.47.
    • “Viatris said the addition of Pacira’s Exparel and Zilretta products to its proposed meloxicam treatment for moderate-to-severe acute pain, positions the Canonsburg, Pa., company as a leader in non-opioid pain-management therapies.”
  • and
    • Argenx ARGX shares fell sharply after the biotech company stopped a late-stage clinical trial of its Vyvgart drug due to lack of efficacy for the treatment of autoimmune condition Sjogren’s disease.
    • “Shares in Argenx were down 18% in European morning trading Thursday, wiping out the stock’s gains in the year to date. If sustained until close, this would be the stock’s biggest one-day percentage drop since December 2023.
    • “The Amsterdam-based company said it would discontinue the study following the recommendation from an independent data-monitoring committee, which concluded that the trial would fall short of its primary goal.
    • “The study evaluated the effects of Vyvgart in subcutaneous formulation in adults with moderate-to-severe Sjogren’s disease, a chronic autoimmune disorder that can cause symptoms including dry eyes and mouth, fatigue and joint pain. No new safety signals were identified in the trial, and safety data were consistent with the drug’s known profile, Argenx said.”
  • BioPharma Dive adds,
    • “On Wall Street, a major search is underway to find struggling public companies that can serve as the raw materials for a niche but booming business. A promising candidate may have just emerged.
    • “This business revolves around “reverse mergers,” a type of deal where a private company combines with a public counterpart, often as a quick way to access the broad and deep-pocketed array of investors found on marketplaces like the Nasdaq. While previously disparaged, reverse mergers have recently become so popular that some deal experts question whether there are enough quality “shell” companies to meet the demand.
    • “Shell hunters could have another option following a Tuesday announcement from Caribou Biosciences, the once high-flying biotechnology startup co-founded by CRISPR gene editing pioneer Jennifer Doudna. In a statement, Caribou CEO Rachel Haurwitz said the current financing environment has made it “increasingly challenging” to secure the money needed to advance the company’s two main research programs, which focus on a hard-to-make form of medicine known as “off-the-shelf” cell therapy.” * * *
    • “To Daina Graybosch, an analyst at Leerink Partners who covers Caribou, the natural end for the company now is either a reverse merger or an acquisition by Tang Capital, a San Diego-based investment firm that made a name for itself by buying up cash-rich biotechs and returning much of their value to shareholders. Caribou ended the second quarter with $114 million worth of cash, cash equivalents and marketable securities.”

Midweek update

David Ermer–Agentic & Generative AI, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Fierce Healthcare reports,
    • “A group of 17 senators penned a letter to U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. seeking more information on recent appointments to a key health panel—echoing concerns of key medical groups.
    • “In the letter (PDF), the legislators called the appointments a “major break from the historic makeup of [the] U.S. Preventive Services Task Force (USPSTF) membership,” as it is typically comprised of primary care practitioners and preventionists.
    • “Kennedy named eight new members to the USPSTF in mid-September—five of whom were specialists and one healthcare finance expert. The new appointments came months after Kennedy dismissed the panel’s vice chairs and did not replace five other members after their terms expired at the start of 2026.
    • “Legislators expressed concerns over an April 23 Federal Register notice seeking nominations for the panel, given the change in nominee parameters—outside of primary care and preventive medicine—and timeline. The letter notes members in specialty areas have “always played a role” in the panel’s operations, though primarily in consultant roles in part to avoid conflicts of interest.”
  • The American Hospital Association News relates,
    • “The Health Resources and Services Administration Maternal and Child Health Bureau has released the latest data from the National Survey of Children’s Health. The survey provides national and state-level data on children’s physical and mental health, healthcare access and quality, special healthcare needs, adverse childhood experiences and family and community well-being. HRSA also plans to release a data brief featuring survey findings on the health and well-being of children living in rural communities.”
  • Beckers Hospital Review tells us,
    • “CMS is penalizing 2,334 hospitals, about 80% of those evaluated, under the Hospital Readmissions Reduction Program in fiscal 2027, according to new CMS data. The penalties took effect on Oct. 1.” * * *
    • “The share of hospitals receiving no penalty will drop to 19.8% (578 hospitals) from 21.8% (641) in 2026. The bulk of hospitals, 71.8% in fiscal 2027 compared with 70.1% in 2026, will see penalties below 1%.”

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

  • Reuters reports,
    • “The US Food and Drug Administration has expanded the use of Novartis’ (NOVN.S), drug to treat adults with ​a chronic skin condition that causes recurring itchy welts [Rhapsido], ‌the Swiss drugmaker said on Wednesday.
    • “The condition, called symptomatic dermographism, is a form of chronic hives in which scratching, rubbing or ​friction on the skin can trigger itchy welts.
    • “The ​approval adds to momentum for the drug, remibrutinib, which investors ⁠have increasingly focused on after recent late-stage failures of the ​company’s cholesterol drug pelacarsen and muscle-wasting disease therapy del-desiran ​increased scrutiny of its pipeline.”
  • PharmExec relates,
    • “The FDA has approved Pfizer’s Tukysa (tucatinib) in combination with trastuzumab and pertuzumab as maintenance treatment for adults with unresectable locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have completed induction therapy, the company announced Oct. 7.1
    • “The decision moves the oral therapy from later-line use into the first-line setting, where it is added to an established antibody pair.”
  • Stock Titan adds,
    • “vTv Therapeutics (Nasdaq: VTVT) received FDA Orphan Drug Designation for HPPD, its investigational oral treatment for sickle cell disease.
    • “Preclinical studies at Augusta University used the Townes sickle cell disease mouse model. HPPD was orally active and well tolerated, increased fetal hemoglobin, and reduced oxidative stress and red blood cell sickling. Fetal hemoglobin increases were time- and dose-dependent, with effects comparable to or exceeding hydroxyurea, the current standard fetal hemoglobin-inducing therapy.
    • “vTv said the designation supports partnering discussions for HPPD while it continues to prioritize cadisegliatin, its lead late-stage type 1 diabetes program. HPPD remains investigational; its safety and efficacy have not been established, and approval or commercial availability is not guaranteed.”

No Surprises Act News

  • The Coalition against Surprise Medical Billing reports,
    • “After a new federal rule slashed the administrative fee for initiating IDR disputes by 87% — from $115 to just $15, nearly 400,000 disputes were initiated in July 2026 alone. This 24% jump in just one month is one of the latest signals that the IDR process has veered even further off course and needs an overhaul.
    • “IDR was supposed to be a last resort for resolving legitimate payment disputes between providers and health plans. Instead, organizations built to file disputes at scale have turned it into a profit center — initiating over 7 million disputes between April 2022 and the end of July 2026. The result is more administrative burden, more unnecessary costs, and more pressure on the employers, workers, and families who ultimately pay the bill. IDR costs have increased to $22.4 billion, according to recent data published in Health Affairs.” * * *
    • “An overused IDR system drives up costs across the entire healthcare system. Every dispute requires employers and health plans to spend resources processing and defending claims, while arbitration outcomes drive higher payments that ultimately put pressure on premiums and healthcare costs.”

From the fraud, waste, and abuse front,

  • Beckers Hospital Review reports,
    • “Federal prosecutors have secured guilty pleas or prison sentences in at least six durable medical equipment fraud cases tied to more than $1.5 billion in claims since late May, and CMS has barred 11 DME suppliers from Medicare Advantage payments.
    • “The cases follow a familiar pattern: telemarketers target Medicare beneficiaries, practitioners sign orders for orthotic braces without examining patients and DME companies bill Medicare for equipment no one needed. Becker’s tracked DME fraud actions against 10 people between March 24 and May 26.
    • “CMS imposed a six-month moratorium on new Medicare enrollment for certain DME, prosthetics, orthotics and supplies providers in February, citing more than $1.5 billion in suspected fraudulent billing stopped in 2025.  The moratorium expired Aug. 27, according to the American Orthotic & Prosthetic Association. On Sept. 8, CMS barred 11 DMEPOS suppliers from future Medicare Advantage and Part D payments, citing more than $3.4 billion in suspected fraudulent billing in 2025 and 2026.”
  • STAT News adds,
    • “In a warning to life sciences companies, the Department of Justice last week issued a new directive for combating fraud that made a point of noting the agency will pursue violations of a federal law that tightly regulates the pharmaceutical industry.
    • “Typically, the agency has pursued health fraud cases centered on providers, clinics, home health agencies, and hospices. By expressly including the Federal Food, Drug, and Cosmetic Act in the directive, the National Fraud Enforcement Division appears to be placing drug and device makers, among others, more clearly in its crosshairs.
    • “This is a subtle but significant expansion of their jurisdiction,” said Kevin Lowell, a member of the Miller & Chevalier law firm, who spent a decade at the DOJ, where he most recently had been a deputy chief in the National Fraud Enforcement Division’s health care fraud section.
    • “The directive brings into focus all of the FDA-regulated companies and the division is pointing to a specific statute that refers to a part of the health care industry that has not previously been a focus. … And it’s one of first items on the list of priorities” for investigating potential fraud.”

From the judicial front,

  • STAT News reports,
    • “The brand drug industry’s main trade group is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries.
    • “The Pharmaceutical Research and Manufacturers of America said Wednesday that it had filed a complaint in the U.S. District Court for the District of Columbia asserting that the “most-favored nation” pilot in Medicare Part B exceeds Medicare’s statutory authority.
    • “The pilot, called GLOBE, is not expected to have much impact because the administration exempted all but a handful of companies in return for their agreement to voluntary deals to charge Medicaid MFN prices. 
    • “But it would set a precedent that the industry wants to nip in the bud. PhRMA says the voluntary agreements are acceptable, but the mandatory GLOBE program is not.
    • “The administration is still considering a separate pilot, called GUARD, that would require MFN prices in Medicare Part D. The status of that proposal is not clear.”
  • Beckers Hospital Review adds,
    • “Hospitals affiliated with Nashville, Tenn.-based HCA Healthcare have sued multiple insurers over alleged claim denials and reimbursement issues in 2025 and 2026. These cases contribute to a broader landscape of legal battles between providers and insurers.
    • “Most recently, seven hospitals filed a lawsuit Oct. 5 against Anthem Blue Cross and Blue Shield Georgia, part of Elevance Health. The complaint argued the insurer is on the hook for more than $501,213 in reimbursement, alleging underpaid or denied claims.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “The overall mortality rate for U.S. patients with cardiovascular disease (CVD) has improved significantly in the last two decades, according to new findings published in JACC.[1] However, despite the continued efforts of cardiologists and other cardiovascular care professionals, disparities remain for certain racial and/or ethnic groups. 
    • “This new analysis represents a county-by-county dive into the heart health of Americans from 2000 to 2019. Data came from both the U.S. National Vital Statistics System and the National Center for Health Statistics.
    • “In total, the study’s authors found that CVD mortality rates “varied substantially” from one county to the next. There were often considerable differences in the same state. This highlights the importance of ensuring all patients, no matter where they live, receive high-quality care. 
    • In 2019, the overall age-standardized mortality rate (ASMR) for CVD in the United States was 237.8 deaths per 100,000 adults. The ASMR was the highest for Black patients and the lowest for Asian patients.” 
  • Beckers Clinical Leadership relates,
    • “A coalition of Texas health systems, professional organizations and community groups has launched a five-year plan to eliminate cervical cancer in the state.
    • “The Texas Lone Star Cervical Cancer Elimination Plan 2027-2032 was developed by the Cancer Alliance of Texas Cervical Cancer Elimination Priority Area Workgroup, according to an Oct. 7 news release from Houston-based University of Texas MD Anderson Cancer Center.
    • “Cervical cancer elimination is defined as fewer than four new cases per 100,000 women a year. Texas’ current cervical cancer rate is 9.5 cases per 100,000, with rates in some counties reaching 15 to 21 per 100,000. Uninsured, rural, border and minority communities carry the heaviest share of cases, the release said.
    • “The plan is built on three pillars: vaccination, screening, and timely follow-up, diagnosis and treatment. Read the full plan here.” 
  • The American Hospital Association News tells us,
    • “As part of the AHA’s Opportunities for Innovations in Rural Maternal Care initiative, a recent Commonwealth Fund blog discusses strategies hospitals can use to sustain maternal care within the communities they serve. Hear from Julia Resnick, AHA senior director of health outcomes and care transformation, and Aisha Syeda, AHA senior program manager of health outcomes and care transformation, on ways to solidify leadership commitment, build a skilled workforce, strengthen partnerships and address community needs. LEARN MORE“
  • The latest post of NIH Research Matters covers the following topics:
    • Device helps people with paralysis communicate
      • “A brain-computer interface linked to a virtual avatar helped people with paralysis express speech and body language at the same time.
      • “Translating neural signals for both types of communication could enable people with paralysis to express themselves more fully.”
    • Improving lung cancer detection
      • “Researchers developed a protein-based MRI contrast agent that could detect a common lung cancer in mouse models and determine if it spread to other organs.
      • “With further development, the approach could help doctors detect lung cancer earlier and tailor treatment to the needs of each patient.”
    • Estimating cognitive impairment risk, timing
      • “Combining blood p-tau217 levels together with APOE4 gene status improved predictions of dementia risk.
      • “The findings may help doctors better assess patients’ risk for cognitive impairment and estimate when symptoms may develop.”
  • Radiology Business points out,
    • “A minimally invasive, image-guided procedure can provide lasting relief for carpal tunnel syndrome, according to new research published in RSNA’s Radiology. 
    • “This common occupational ailment is frequently encountered among the middle-aged, leading to morbidity and loss of work hours. Common carpal tunnel syndrome management strategies may include conservative therapy or surgical decompression, experts note. 
    • “However, image-guided interventions such as steroid shots or nerve hydrodissection—which involves carefully injecting fluid around the impacted area—have emerged as alternatives for mild to moderate cases. Researchers in India recently aimed to investigate the efficacy of these options, sharing their findings Tuesday. 
    • “Most of our patients had been suffering from carpal tunnel syndrome for months to years and did not get much relief despite trying various treatments like pain medications, splints, lifestyle modification and corticosteroids,” study co-author Anupama Tandon, MD, a professor with the University College of Medical Sciences and Guru Teg Bahadur Hospital in Delhi, India, said in a statement Oct. 6. “It came as a pleasant surprise to find that a simple procedure of dissecting the median nerve under ultrasound guidance with normal saline provided them long-term relief.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of research headed by a team at the University of Birmingham suggest that inflammatory conditions in the brain, including traumatic brain injury (TBI) and degenerative diseases such as Alzheimer’s disease and Parkinson’s disease, could be targeted with an existing developmental drug.
    • “Using live cultures of human brain cells and slices of brain tissue obtained during neurosurgery, the researchers, headed by Nicholas Barnes, PhD, professor at the University of Birmingham College of Medicine and Health, investigated the role of the P2X7 receptor, which is responsible for triggering inflammatory signaling. Their findings revealed that these P2X7 receptors drive the release of cytokines involved in controlling inflammation. By blocking this receptor with a specific antagonist, the team was able to significantly reduce the inflammatory response in human brain tissue.
    • “The team suggests that their results could open the door to treating a wide spectrum of chronic neurological conditions, including TBI, neurodegenerative diseases, and even psychiatric disorders such as depression and psychosis, which are increasingly understood to have a neuroinflammatory component.”

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

  • Beckers Payer Issues reports,
    • “Harbor Health, an Austin, Texas-based insurer that also runs its own medical clinics, plans to acquire 27 Village Medical primary care clinics in the Houston area.
    • “The deal is expected to close at the end of the year, according to an Oct. 6 news release, and financial terms were not disclosed. Once the deal closes, Harbor will operate nearly 70 clinics and more than double its count of physicians and advanced practice providers.
    • “The company offers large employer plans in 29 Texas counties, including the four Houston-area counties. It will also offer individual and family plans on the Texas exchange in 13 of those counties for 2027.
    • “Village Medical is the clinic brand of VillageMD, which Walgreens previously owned a majority stake in. VillageMD has operated as a standalone company since private equity firm Sycamore Partners took Walgreens private in August 2025, while Cigna continues to hold a minority stake. Harbor also bought 32 VillageMD clinics in Austin, Dallas, El Paso and San Antonio in September 2025.” 
  • Fierce Healthcare relates,
    • “Cigna is rolling out a new patient experience platform that aims to harness the power of data to drive greater personalization.
    • “Called Health Sense, the tool brings together information on an individual’s health needs, medical coverage, pharmacy benefits, cost exposure and other previous interactions with the health plan. This allows for more complete context, as the insurer’s clinical teams offer tailored experiences to members.
    • “Having a more complete picture of the patient also allows Cigna’s clinicians and care managers to collaborate more effectively with a member’s treating providers, the company said. It surfaces insights for the member about next steps, potential costs for care, any supports available in-network and potential preparation for an upcoming appointment.
    • “Cigna plans to roll out Health Sense in early 2027, with an initial focus on members with cancer or cardiometabolic conditions.”
  • Beckers Behavioral Health tells us,
    • “Mental healthcare, including care for substance use disorders, accounted for 7% of total U.S. healthcare expenditures from 2021 to 2023, Medscape reported Oct. 7. Annualized mental health spending totaled $174 billion, compared with $2.5 trillion in overall healthcare expenditures captured by the survey.
    • “Researchers analyzed data from the 2021 to 2023 Medical Expenditure Panel Survey, which represents the civilian noninstitutionalized U.S. population. The analysis included 67,532 person-year observations, including 15,407 involving outpatient mental healthcare. The study, led by Carlos Blanco, MD, PhD, of the National Institute on Drug Abuse in Bethesda, Md., was published online Sept. 30 in JAMA Psychiatry.”
  • Modern Healthcare informs us,
    • “Prime Therapeutics, one of the largest U.S. pharmacy benefit managers, aims to shift to upfront drug pricing and away from a complicated rebates-based system that critics say increases patient costs. 
    • “The company intends to offer its clients — health insurers and employers — what it calls a net cost model for 2028, Chief Executive Officer Mostafa Kamal said in an interview Wednesday. He said patients should get the discounts that drug companies pay when they fill their prescriptions at the pharmacy. Prime seeks to keep its clients’ overall costs the same or lower than the current setup.” 
  • BioPharma Dive adds,
    • “Caribou Biosciences, one of the first companies founded to advance CRISPR gene-editing technology in medicine, is discontinuing research, laying off staff and looking for “strategic alternatives” because it can’t raise the money to continue.
    • “The decision means the end of Caribou’s work on two “off-the-shelf” CAR-T cancer therapies, one of which was ready for Phase 3 testing. “Despite the progress we’ve made, the current financing environment for allogeneic CAR-T cell therapies has made it increasingly challenging to secure the capital necessary to responsibly advance these programs,” Caribou CEO Rachel Haurwitz said in a statement Tuesday.
    • “The company’s board will consider mergers, acquisitions or other transactions related to the company as a whole or for its assets, Caribou said. In the meantime, a “substantial reduction in workforce” will be mostly completed by the end of the year, the company added.”
  • Healthcare Dive points out,
    • “Telehealth company Teladoc Health is adding new artificial intelligence capabilities to its virtual care platform for hospitals and health systems, it announced Wednesday.
    • “The new capabilities include a “contactless” approach to remotely monitoring patients’ vital signs and an AI scribe that will record and transcribe clinical encounters to create notes, according to the announcement.
    • “The scribing tool is now available but only select customers can currently use the vitals monitoring feature in private preview. The latter is expected to be released broadly in December.”
  • Becker’s Hospital Review notes,
    • “The American Medical Association has honored 92 hospitals, health systems and medical groups through its 2026 Joy in Medicine program.
    • “The Joy in Medicine program recognizes healthcare organizations for their commitment to “reduce burnout and improve the professional fulfillment physicians find in caring for patients,” according to an Oct. 7 news release from the AMA.
    • “There are three levels of recognition in the program, gold, silver and bronze, which are valid for two years. Find the hospitals and health systems honored in the AMA’s 2025-26 Joy in Medicine program here.” 
  • McKinsey & Co. discusses the AI powered future of healthcare.
    • “AI won’t replace clinicians, but it can improve quality, increase access, and reshape the workforce, payments, and patient volumes. Today, AI can perform some 16 to 22 percent of US outpatient care.”

Nobel Prize

  • The Wall Street Journal reports,
    • “Henri Kagan and Kenso Soai were awarded the 2026 Nobel Prize in Chemistry for breakthroughs that have helped advance the development of modern pharmaceuticals.
    • “Kagan, of France’s Université Paris-Sud, and Soai, who is based at Tokyo University of Science, will share the 12 million Swedish kronor, or roughly $1.2 million, prize.
    • “The pair’s research relates to a concept called homochirality, which is the tendency of living systems to use just one of two possible mirror-image forms of a molecule. It’s important for the synthesis of small molecules in drugs that can interact with amino acids and sugars in the body in powerful ways.
    • “Thanks to Henri Kagan and Kenso Soai, we now know how homochirality can emerge,” the Royal Swedish Academy of Sciences said Wednesday. “Their discoveries have been decisive for chemists who design reactions for the manufacture of pharmaceuticals.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services has published its list of participants for its mandatory Comprehensive Care for Joint Replacement Expanded Model, or CJR-X. The payment model focuses on lower extremity joint replacement procedures. CMS is requesting participating hospitals to complete the online primary point of contact form and identify two individuals to serve as their primary points of contact for CJR-X-related communications from the agency. The model, which initially ran in specific geographic areas from 2016-2024, was expanded this year to all acute care hospitals nationwide, except those participating in the Transforming Episode Accountability Model and hospitals located in Maryland. Participation in CJR-X begins Jan. 1, 2028.”
  • Beckers Payer Issues points out “6 payers entering ACA markets in 2027” and “12 insurers exiting ACA market” at the end of this year.
  • Kiplinger projects IRMAA brackets for 2027.
    • “If you have Medicare Part B or Medicare Part D prescription drug coverage, your monthly costs could look drastically different than the standard rates. High-income retirees are subject to the Income-Related Monthly Adjustment Amount (IRMAA) — a progressive surcharge added directly to your Medicare premiums if your income crosses specific thresholds.
    • “Understanding how the projected 2027 IRMAA brackets are calculated and how the two-year tax lag impacts you is essential to preserving your retirement savings. Failing to plan for these thresholds can trigger an unexpected financial “cliff,” at which a single dollar of excess income can cost you thousands in annual surcharges.
    • “This year, forecasting the 2027 numbers has been difficult because the Bureau of Labor Statistics (BLS) did not publish official CPI-W data for October 2025, due to last year’s federal government shutdown. The Centers for Medicare & Medicaid Services (CMS) should release the numbers by early November.”

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

  • FedSmith points out 12 pieces of information to gather and consider before you start comparing FEHB or PSHB plans this coming Open Season.
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Varney & Co. on Fox Business for his first television appearance since President Trump announced his appointment as Vice Chair of the White House Super Intelligence Task Force. Kupor discussed the President’s vision for maintaining American leadership in superintelligence, protecting national security, and holding industry accountable while advancing innovation.”
  • OPM Director Kupor writes about technology development in his Secrets of OPM blog.
    • “In 1980, AT&T hired McKinsey to forecast the size of the future U.S. cell phone market (for the year 2000). McKinsey forecast the market at about 900,000 subscribers, based in large part on the fact that cell phones in 1980 were bulky, had poor battery life, patchy coverage, and high costs. McKinsey was only slightly off; by the year 2000, the actual figure was 109 million, and worldwide, roughly 900,000 new mobile subscribers were being added every three days.
    • “What do these markets and nearly every other technology market have in common?
    • “An over-abundance of focus on the current limitations often blinds people to how quickly the technology is in fact improving. History has taught us repeatedly that one person’s toy is another person’s opportunity.”

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

  • Per a BridgeBio news release,
    • “BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.
    • “Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia,” said Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias. “We also understand that for many families, it’s about more than just height or having an oral option. To that end, we are excited by the data we have generated on arm span, sleep apnea, ear infections, and proportionality, and we remain committed to further evaluate and share the impact of oral infigratinib on measures beyond growth. We are grateful to the families and investigators who have partnered with us, and we are moving with urgency alongside the FDA.”
  • Cardiovascular Businss reports,
    • “Abbott has secured a new approval from the U.S. Food and Drug Administration (FDA) that allows users of its popular CardioMEMS platform to view their own pulmonary artery pressure (PAP) readings and receive personalized updates through a smartphone app. 
    • “Heart failure patients with an implanted CardioMEMS sensor use the CardioMEMS Hero device, which just gained FDA approval in February, to monitor their PAP over time. This approval helps those patients track any PAP changes through the CardioGuide HF App. According to Abbott, this helps patients take a more active role in managing their own health.
    • “Abbott is reshaping heart failure care by bringing meaningful, actionable information directly to patients,” Katie Spayde, vice president of Abbott’s heart failure division, said in a statement. “For many people living with heart failure, managing their condition is part of everyday life. By giving patients greater visibility into their condition, these new capabilities help them stay informed, engaged and connected to their care between doctor visits.”
  • and
    • “Riverain Technologies, an Ohio-based cardiothoracic imaging company, has announced that its U.S. Food and Drug Administration-cleared suite of artificial intelligence (AI) tools is being added to RapidAI’s Rapid Enterprise Platform.
    • “The Rapid Enterprise Platform, a collection of dozens of advanced algorithms, is already helping radiologists evaluate imaging results in more than 2,500 hospitals all over the world. This partnership gives those users access to Riverain’s ClearRead Chest suite, which scans chest CTs and chest X-rays for signs of pulmonary nodules, pneumothoraces and coronary artery calcification. 
    • “ClearRead was developed to help radiologists see subtle chest findings more clearly and confidently within the workflows they already rely on every day,” Steve Worrell, CEO of Riverain Technologies, said in a statement. “By integrating ClearRead Chest into the Rapid Enterprise Platform, we’re expanding access to our advanced chest imaging technology to support earlier detection of leading global killers like lung cancer, and cardiovascular disease and reduce the burden on radiologists facing increasingly complex imaging workloads.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Heart failure contributed to 452,573 U.S. deaths in 2023, a new peak, and the disease is increasingly affecting younger adults, a new Heart Failure Society of America report found. 
    • “The “HF Stats 2026: An Updated Report on Heart Failure Epidemiology and Outcomes Statistics from the Heart Failure Society of America” report compiles principal findings for a comprehensive picture of the changing state of heart failure in the U.S., according to an Oct. 5 association news release. 
    • “Nearly 1 in 4 Americans will develop heart failure in their lifetime, the report found. Heart failure contributed to 452,573 deaths in 2023, representing 14.6% of all-cause deaths. Age-adjusted heart failure mortality rose approximately 37% from 2010 to 2023 — reversing more than a decade of progress. Early 2024 data suggest the increase is continuing. 
    • “Between 2010 and 2022, heart failure hospitalization rates rose in adults younger than 65 but declined in adults over 65.
    • “Between 2001 and 2020, crude heart failure mortality rates jumped 121% for adults 25 to 44 and 96% for those 45 to 64. By comparison, older adults saw an increase of 21% to 23%, “signaling a fundamental shift in the epidemiological landscape of heart failure,” the report said.”
  • and
    • “The CDC is calling for greater surveillance of Cladophialophora bantiana after a clinical reference laboratory recorded a sharp increase in detections of the rare fungus, which is associated with a 60% to 70% case-fatality rate.
    • “The findings were published Oct. 2 in the CDC’s Morbidity and Mortality Weekly Report.”
  • Chief Healthcare Executive adds,
    • “A substantial cohort with early cardivascular disease, occult cancers, metabolic and autoimmune disease produces actionable pre-symptomatic signals, but remains unengaged due to care models optimized for reactive, symptom-driven encounters. 
    • “Existing clinical data are often sufficient for earlier identification; the limiting factor is delivery infrastructure that operationalizes insights into consistent follow-up, diagnostics, referral, and treatment at scale. 
    • “AI and analytics can reduce mortality in acute settings, but predictive models create value only when embedded in workflows that reliably trigger intervention rather than generating unactioned risk flags. 
    • “Precision medicine illustrates the same implementation bottlenecks, with barriers including reimbursement, workflow integration, clinician adoption, data management, and engagement; only ~35% of eligible lung cancer patients receive biomarker-driven therapy. 
    • “Competitive advantage in precision health will hinge less on maximal data acquisition than on building an “operating system” that converts what is already known into earlier, lower-cost, outcome-improving care pathways.”
  • The American Medical Association lets us know what doctors want patients to know about headaches.
    • “Headaches affect nearly everyone, though some can be especially debilitating like migraine attacks. Each type requires specific treatment and approaches.”
  • Health Day relates,
    • “If you’ve developed type 2 diabetes before age 45, it’s possible to push the disease into remission with weight-loss dieting and a fitness program that includes aerobic and muscle-building resistance exercise, a new study confirms.
    • “In early-onset type 2 diabetes, combining structured aerobic and resistance exercise with a low-calorie diet produces high remission rates, induces fat loss while preserving muscle mass, improves muscle quality and function, enhances cardiovascular health, and leads to meaningful improvements in patient-reported outcomes,” concluded a team co-led by Dr. Kaberi Dasgupta. She directs general internal medicine at McGill University in Montreal.
    • “Her team presented its findings Wednesday in Milan at a meeting of the European Association for the Study of Diabetes. The findings were simultaneously published in The Lancet Regional Health Americas.”
  • and
    • “A teenager’s daily step count may improve more than their physical health — it may also help protect their mental health.
    • “Researchers tracked more than 5,500 adolescents (average age: 12), using Fitbits, brain scans and mental health assessments.
    • “After one year, teens who took 12,000 or more steps a day had fewer mental health symptoms than those who took fewer than 5,000.
    • “More steps were also associated with greater thickness in two specific regions of the brain involved in motor and cognitive functions.
    • “Dr. Claudine Higdon, a child and adolescent psychiatrist at Northwell Health in Glen Oaks, New York, called the findings exciting.
    • “The good thing about it is this particular brain region is really linked with decision-making; the attention part of the brain,” said Higdon, who reviewed the study results. “And so that can thereby improve choices and improve impulse control. And that might also lead to improved mental health.”
  • MedScape tells us,
    • “The list of possible side effects attributed to statins is long: muscle pain, memory problems, depression, sleep disturbances, diabetes, and liver damage. However, a meta-analysis by the Cholesterol Treatment Trialists’ (CTT)Collaboration in The Lancet calls many of these associations into question. At the same time, the study confirmed that certain effects on muscles, the liver, and glucose metabolism can indeed occur. What matters, however, is their magnitude — and that is usually significantly lower than what the public criticism of these drugs would suggest.”
  • BioPharma Dive informs us,
    • “A combination of Genmab and AbbVie’s bispecific antibody Epkinly and standard chemotherapy cut the risk of disease progression or death by nearly half when compared to chemo alone in a Phase 3 trial in newly diagnosed lymphoma patients, the companies said Monday.
    • “The data in diffuse large B-cell lymphoma surpassed investor expectations, bested a rival Roche treatment and could significantly propel sales of Epkinly, one Wall Street analyst said. Epkinly is now on track to become the first drug of its kind to gain approval in first-line DLBCL, the most common form of lymphoma. 
    • “Genmab splits ownership rights to Epkinly with AbbVie and reported $312 million in global net sales on the therapy in the first half of the year.”
  • Per an Arrivent news release,
    • “ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the FURVENT (NCT05607550) Phase 3 trial evaluating firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review (BICR). Clinical benefit was observed with secondary endpoints such as PFS by investigator’s assessment and confirmed objective response rate by BICR. Although not yet mature, a trend toward an improvement in overall survival was also observed.  The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified.
    • “These disappointing results are not what we hoped for, particularly for the patients with EGFR exon 20 insertion-mutant NSCLC who urgently need more effective treatment options,” said Bing Yao, Ph.D., Chairman, Chief Executive Officer of ArriVent. “While the safety profile observed with firmonertinib was consistent with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study. We are deeply grateful to the patients, investigators and clinical teams who made this program possible and are evaluating the full FURVENT dataset as we determine the most appropriate development path for firmonertinib.”

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

  • Fierce Healthcare reports,
    • “Highmark is making a change at the top, with Karen Hanlon stepping to the role of CEO on Jan. 1.
    • “The Pittsburgh-based insurer announced Tuesday that current CEO David Holmberg, who has held the title since 2014, will transition to executive chairperson at Highmark. Hanlon, who is currently Highmark’s president, will become the company’s first female CEO.
    • “At the helm of Highmark, Hanlon will spearhead strategy, operations and performance across Highmark’s health plans, diversified businesses and Allegheny Health Network. She’s spent nearly three decades at Highmark, during which the organization grew from a $17 billion revenue business in 2014 to a projected $35 billion at the end of this year.”
  • and
    • “Option Care Health, a provider of infusion therapy services, is being acquired by private equity firm CD&R and healthcare conglomerate McKesson in a deal valued at $5.8 billion, the companies announced Tuesday morning. 
    • “The purchase will take Option private at a per-share offer price of $32.05, a 37% premium over the company’s closing price. Its stock had begun trending higher after close when early reports of the definitive agreement began to swirl, and as of Tuesday morning, it is trading at about $31 per share.
    • “The deal is expected to close in the first half of 2027, subject to customary closing conditions like regulatory approvals and shareholder go-ahead. It would leave CD&R with a 51% stake in the company and McKesson a roughly 49% interest, for which it plans to invest about $1.4 billion. The agreement also outlines a framework for McKesson to acquire CD&R’s interest in the future, according to the announcement.”
  • Beckers Hospital Review relates,
    • “HCA Healthcare owned more general hospitals than any other U.S. health system at the end of 2025, according to an analysis from the Lown Institute, published Oct. 6.
    • “The analysis draws on Lown’s hospital ownership dataset, which tracks the ownership of U.S. acute care and critical access hospitals from 2020 through 2025. Counts may differ from systems’ own figures, since Lown includes only those hospital types.
    • “Together, the 10 largest systems own 695 hospitals, or about 16% of general hospitals, and nearly 20% of beds in the dataset. Their hospitals accounted for about 25% of hospital profits in 2024, based on Medicare cost reports.
    • “Seven of the 10 systems owned fewer hospitals in 2025 than in 2020, according to Lown. Advocate Health added the most, 21 hospitals, following the 2022 merger of Advocate Aurora Health and Atrium Health.”
  • and
    • “Hospitals are the leading source of medical debt in the U.S., with more than half of adults with medical debt owing money for hospital services, according to an Oct. 6 Urban Institute report funded by the Robert Wood Johnson Foundation.
    • “The report draws on December 2025 data from the institute’s Well-Being and Basic Needs Survey. The nationally representative survey covers more than 10,000 adults ages 18 and older, who reported debt owed by themselves or family members.
    • “Overall, 26.6% of U.S. adults said they or a family member owed medical debt.”
  • Fierce Healthcare adds,
    • “Datavant is partnering with identity verification company ID.me to help patients request their medical records faster and more easily via simple digital credentials.
    • “By integrating ID.me’s digital identity verification into Datavant’s Patient Request Tool, the companies aim to reduce friction, speed up access to records and strengthen safeguards against unauthorized access.
    • “ID.me is a secure, private digital identity platform that acts as an independent “identity wallet.” Twenty-three federal agencies, 50 state government agencies and more than 100 healthcare organizations use ID.me for secure identity verification and the company boasts more than 175 million users.
    • “Datavant offers a data exchange network that connects more than 80,000 hospitals and clinics, 75% of the 100 largest health systems and an ecosystem of 350-plus real-world data partners. Its platform connects datasets across electronic health records, claims, specialty pharmacy, registries, imaging, labs and social determinants of health. Datavant’s data collaboration platform enables more than 60 million healthcare records to move between thousands of organizations.”
  • and
    • “Gilead Sciences is taking a step into the wellness space to support patients with chronic diseases by offering resources that go beyond physical health. The company is partnering with mindfulness app Calm to provide curated content for those impacted by cancer, HIV and liver conditions. 
    • “More than one-third of people living with HIV in the U.S. experience depression, while 28% have an anxiety disorder, according to Gilead and Calm. Additionally, those with HIV often struggle with stigma that can stir up feelings of shame and anxiety. 
    • “Meanwhile, about 50% of people with cancer experience distress, with some two in ten people with cancer reporting symptoms of depression. For those with liver conditions such as primary biliary cholangitis (PBC), symptoms such as fatigue, chronic itch and brain fog can take a toll on daily life, Gilead points out.”  

Nobel Prize

  • The Wall Street Journal reports,
    • “Belgian particle physicist Francis Halzen was awarded the 2026 Nobel Prize in Physics for his contributions to astronomy and his work on the IceCube Neutrino Observatory at the South Pole.
    • “Francis Halzen has led an international team of researchers and engineers who have provided us with a fantastic instrument,” said Mark Pearce, chair of the Nobel Committee for Physics, on Tuesday.
    • “His tenacity and scientific vision has paved the way for a new kind of astronomy.”
    • “As the spearhead behind the IceCube Neutrino project, Halzen wanted a way to capture and study astrophysical neutrinos—tiny, electrically neutral subatomic particles from deep space.
    • Neutrinos with extremely high energies are created in the same environments as other types of particles, but unlike other particles, neutrinos reach Earth without changing direction or losing energy. This means they can provide information about distant galaxies that isn’t available in any other way.
    • “Halzen, who is 82-years-old and based at the University of Wisconsin-Madison, first presented his vision for capturing high-energy neutrinos at the South Pole—a giant particle detector buried deep in the Antarctic ice—in 1988.”