Tuesday report

Congress

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.”

Weekend update

David Ermer–CDC, CMS, Congress, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Congress remains on the campaign trail this week.
  • Beckers Hospital Review reports,
    • :CMS is pitching new guardrails for pharmacy benefit managers and Medicare Advantage plans under a proposed rule released Oct. 16.
    • “The proposed rule would implement sections of the Consolidated Appropriations Act of 2026. Comments are due Dec. 15.
    • “Starting Jan. 1, 2028, PBMs and their affiliates would only be able to accept flat-dollar, itemized service fees for Part D drugs. The fees could not depend on drug prices or rebates. Manufacturer rebates and discounts would remain allowed if they are fully passed through to the plan sponsor.” * * *
    • “Beginning in contract year 2028, MA organizations would need to estimate “a letter grade” for their provider directory accuracy based on a provider sample. In 2029, CMS would publicly post these scores, and plans would need to show them in their directories.
    • “If an MA enrollee books a provider listed as in network, that enrollee would pay no more than the lesser of the in-network or other cost-sharing. This would still apply if the provider ends up being out of network. That protection would begin in contract year 2028.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services announced that it will exercise enforcement discretion for inpatient rehabilitation facility admissions from Oct. 1, 2026 through March 31, 2027, with respect to the timing of the initial interdisciplinary team meeting requirement. As of Oct. 1, the initial IDT meeting must occur on or before four days from the date a patient is admitted to an IRF in order to implement appropriate treatment services; establish or review the patient’s stated rehabilitation goals; and identify problems that could impede those goals. This requirement was finalized in the fiscal year 2027 IRF prospective payment system final rule. The AHA had urged CMS not to finalize this requirement, in part due to its inconsistent descriptions of when the four-day threshold would be met relative to admission. 
    • “During this six-month moratorium, Medicare Administrative Contractors will enforce the initial IDT meeting timing requirement that had been in effect during FY 2026. This means they will not deny or non-affirm a claim based solely on the timing of the initial IDT meeting if an IDT meeting occurs at least once per week throughout the duration of a patient’s stay. CMS said that all other applicable IRF coverage and documentation requirements remain in effect.” 

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

  • The FEHBlog has noticed that 2027 FEHB and PSHB brochures are beginning to shown up in downloadable form on plan open season websites.
  • OPM posted in the Federal Register a Paperwork Reduction Act notice about its efforts to extend its Postal Service Health Benefits Program portal for collecting family member documentation to the FEHB Program. The public comment deadline is December 18. 2026.
  • OPM’s Office of Inspector General posted its Top OPM Management challenges for the current 2027 federal fiscal year.

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services announced that the submission period opened Oct. 16 for petitions to deny the recertification of five independent dispute resolution entities. Members of the public, providers, facilities and others can submit a petition, which must identify the IDR entity seeking recertification and detail the reasons for the petition. The five organizations seeking recertification are Maximus Federal Services, Inc.; ProPeer Resources LLC; C2C Innovative Solutions, Inc.; Medical Evaluators of Texas ASO, LLC; and Federal Hearings and Appeals Services, LLC. The petition period is open through Oct. 23. The departments of Health and Human Services, Labor, and the Treasury will make a final decision on recertification after reviewing any petitions submitted.” 

From the judicial front,

  • Beckers Hospital Review reports,
    • “AbbVie, Bristol Myers Squibb, Boehringer Ingelheim and PhRMA are asking to intervene in the hospital industry’s lawsuit seeking to block HRSA’s revised 340B Rebate Model Pilot Program, according to court filings in the U.S. District Court for the District of Maine.
    • “AbbVie and its Pharmacyclics unit, Bristol Myers Squibb and Boehringer Ingelheim filed a motion to intervene Oct. 14, and PhRMA filed its own motion Oct. 15 in American Hospital Association v. Kennedy. The drugmakers said they want to defend the rebate plans HRSA approved for their drugs, including AbbVie’s Imbruvica, Linzess and Vraylar, Bristol Myers Squibb’s Eliquis and Pomalyst and Boehringer’s Jardiance, Ofev and Tradjenta. They argued that the government’s representation of their interests “may be inadequate,” the standard for intervening, because, unlike HRSA, they face duplicate discount losses and civil penalties.”

From the public health and medical/Rx research front,

  • Beckers Clinical Leadership reports,
    • “The share of flu tests coming back positive rose from 3.9% to 5% in the week ending Oct. 10, the CDC’s first FluView report of the 2026-27 season shows. ED visits and outpatient visits for flu also climbed.
    • “Seasonal flu activity remains low, but test positivity, outpatient visits for flu-like illness, ED visits with a flu diagnosis and lab-confirmed hospitalizations have all been rising since late August or early September. Activity is highest on the West Coast, and the CDC said early-season levels are higher than typical for this time of year but within expected seasonal variation. Influenza A(H1N1) accounted for 96.4% of the influenza A viruses that public health labs subtyped during the week.”
  • Health Day relates,
    • “Poorer maternal dietary quality is associated with infantile colic and eczema, according to a study published online Oct. 12 in JAMA Network Open.
    • “Emily Oken, M.D., M.P.H., from Harvard Medical School and Harvard Pilgrim Health Care Institute in Boston, and colleagues estimated associations of maternal diet quality and intakes of specific allergenic foods with infant eczema and colic in a prospective cohort of 2,128 mother-child pairs unselected for atopic risk. Food frequency questionnaires were administered in early and mid-pregnancy, and the Mediterranean Diet Score (MDS) and Dietary Inflammatory Index (DII) were calculated.”
  • and
    • “If you’re in your 60s, 70s or even older, you might think your days of productively pumping iron are behind you.
    • “That’s just not true, said Dr. Adil Ahmed, an assistant professor in the Joseph Barnhart Department of Orthopedic Surgery at Baylor College of Medicine in Houston.
    • Building and maintaining muscle is a great way to stay all-round healthy, he said.
    • “The protective effect of muscle and muscle mass has been well studied — everything from the musculoskeletal system to orthopedics and even brain health,” Ahmed said in a Baylor news release. “Building muscle in your body has been well shown to delay dementia and the effects of dementia and preserve cognitive function.”
    • “Strength training also helps your bones. It’s one of the best ways to help aging bones stay dense and strong, Ahmed said.
    • “It’s a very good protective long-term process,” he said.” 

From the U.S. healthcare business front,

  • Modern Healthcare tells us,
    • “Health systems are increasingly selling their real estate to ease financial pressure and fuel expansion, and regulators are pushing back.
    • “Health systems are seeking relief from higher costs and lower reimbursement by selling the buildings and land that house their hospital and outpatient facilities. Those deals provide an immediate capital infusion to shore up finances and fund growth, but can expose providers to higher long-term costs as buyers become more selective and state and federal policymakers increase oversight. 
    • “This is trading a short-term fix for a long-term cost,” said Jim Baker, founder and executive director of the Private Equity Stakeholder Project, a nonprofit watchdog group that opposes private equity investment in healthcare.” 
  • BioPharma Dive reports,
    • “Estuary Biotherapeutics, a California-based genetic medicines developer, officially launched on Friday, backed by nine figures worth of funding and a management team stocked with former Biogen leaders.
    • “Forged in 2022, Estuary is built around research conducted by its scientific co-founders Stefan Somlo and Michael Caplan, both professors at the Yale School of Medicine. Somlo’s lab has made major discoveries about an inherited disorder where certain genetic mutations cause cysts that progressively damage the kidneys and often lead to renal failure. Through a landmark study published in the journal Nature Genetics, Somlo’s team found that, in mice, reactivating proteins called polycystins could shrink the cysts and reverse kidney inflammation and scarring.
    • “And in Caplan’s lab, scientists determined that only a small piece of the full polycystin protein is needed to suppress this “autosomal dominant polycystic kidney disease.” Those findings suggest that helpful genetic material can be successfully packaged up and delivered to the kidneys with the standard “viral vectors” used for gene therapy.
    • “Taken together, Estuary believes its technology and expertise will bring about the first-ever treatment that can halt or reverse, rather than just slow, the most common inherited kidney disorder. Estimates hold that ADPKD affects about 1 in every 400 to 1,000 people. Just one drug, tolvaptan, is specifically approved to treat it.”
  • Fierce Pharma offers us a look inside “Teva’s Weltruza launch and Novo’s GLP-1 strategy.”

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.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • Radiology Business reports,
    • “A U.S. senator has introduced legislation that would slash $2 billion in imaging spending while also bolstering radiologist pay. 
    • “Sen. Roger Marshall, MD, R-Kan., recently proposed the Patients First Act of 2026 [(S. 5672)] in the upper chamber. A companion bill to a version introduced in the U.S. House in July, the legislation would tie physician reimbursement in the Medicare program to a measure of inflation. 
    • “The proposal also incorporates language from the Radiology Outpatient Ordering Transmission (ROOT) Act—which would revive the stalled imaging appropriate-use criteria program. If approved, it would require referring physicians to consult clinical decision support before ordering scans, hoping to root out unnecessary and wasteful imaging. 
    • The American College of Radiology—which supports the bill—estimates that the ROOT Act would reduce federal spending on medical imaging by about $2 billion over the next decade. In addition, it would save Medicare beneficiaries another $1.5 billion during the same timeframe. 
    • “The ROOT Act provisions would modernize implementation of Medicare’s Appropriate Use Criteria program for advanced diagnostic imaging,” ACR said in a news update touting its support for the bill on Oct. 15. “The Patients First Act also includes broader Medicare physician payment reforms, including annual payment updates tied to the Medicare Economic Index, changes to Medicare budget-neutrality policies and reforms to quality reporting requirements.”
  • The Government Accountability Office posted a report about private health insurance.
    • “Multiple companies may sell health insurance in a given market, but only a small number of these insurers will have the most enrollees, as we previously reported. Known as market concentration, this can leave enrollees with fewer choices of insurers and higher premiums because of less competition in the market.
    • “Market concentration generally increased from 2011 through 2024, with three or fewer insurers holding at least 80% market share for the individual and employer group markets in at least 36 states. However, concentration in the markets for individuals peaked in 2019 and has become slightly less concentrated since.”
  • The Wall Street Journal explains “How to Get All the Tax Benefits From Your Health-Savings Account.”
    • “An HSA can cushion the blow of medical expenses, but it’s also a tax-favored investment vehicle.” * * *
    • “In 2026, new provisions took effect that benefit individuals with ACA coverage. They enable HSAs to be paired with Bronze and Catastrophic plans, which have the highest deductibles.
    • “This change is good news for several groups. One is self-employed workers. Another is early retirees who use ACA coverage and aren’t yet eligible for Medicare. Still another is the fairly small group who opt only for the ACA’s catastrophic coverage.”

From the U.S. Office of Personnel Management front

  • Bloomberg Law reports,
    • “The Trump administration has removed a mandatory waiting period for internal federal promotions, allowing employees to rise faster through the ranks.
    • “A final rule published Friday by the Office of Personnel Management removes a requirement that new hires remain in their current jobs for a set period before becoming eligible for a promotion. Many were required to stay at a given grade for a year before moving up the pay scale, which Trump administration officials said reinforced backward priorities.
    • “To me, it’s an anti-merit principle,” OPM Director Scott Kupor said in an interview last week. “If you’re doing awesome and we hired you three months ago, and it turns out you’re performing at a level that’s the next grade level relative to where we hired you, we should not have an arbitrary thing that slows us down from promoting you.”

From the U.S. Food and Drug Administration front

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about safety concerns associated with certain delivery systems sold with the Sapien M3 transcatheter mitral valve replacement (TMVR) system from Edwards Lifesciences. The affected devices should not be used for patient care. Any delivery systems that are not part of this recall can still be used like normal.
    • “The FDA announced this early alert due to issues with the Commander M delivery system that clinicians use to implant the Sapien M3 TMVR system during a minimally invasive procedure. Edwards Lifesciences has received multiple reports of balloons bursting during inflation.
    • “Potential injuries associated with balloon burst include embolism and inability to retrieve the device through the guide sheath, which may require additional intervention, including surgery,” according to the FDA’s advisory. “Because this patient population is deemed unsuitable for surgery, these interventions carry a high risk of serious adverse health consequences including death.”
    • “One death and one serious injury have been linked to this issue so far.”
  • Per a FDA news release,
    • “Today, the U.S. Food and Drug Administration approved a new nonprescription eye drop treatment, Brytly, apraclonidine ophthalmic solution, 0.125%, for relief of eye redness due to minor irritations. This is the first nonprescription eye drop with apraclonidine.
    • “Expanding access to safe and effective nonprescription treatments is a priority for FDA,” said Mike Davis, M.D., Ph.D., Director of the FDA Center for Drug Evaluation and Research (CDER). “Today’s approval of Brytly gives consumers a new nonprescription option to manage eye redness conveniently and without needing to see a healthcare provider.”
  • The AP relates,
    • “U.S. health officials are moving ahead with a plan to allow specialty pharmacies to produce certain peptides, a class of largely unregulated injections that have become popular among followers of Health Secretary Robert F. Kennedy Jr. and other wellness influencers.
    • “Kennedy’s Department of Health and Human Services submitted a peptides “interim access policy” to the White House for review, according to a posting Thursday on a government website. The plan was sent to the Office of Management and Budget, which reviews federal rules and regulations with the potential for significant economic impact.
    • “HHS officials did not immediately respond to requests for comment Thursday afternoon.
    • “Peptides are the building blocks of more complex proteins, triggering hormones inside the body needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss.”

From the Medicare Advantage front,

  • Fierce Healthcare reports,
    • “CareCycle, a voice AI company serving Medicare agencies, has launched a free tool that helps Medicare beneficiaries compare plans.
    • “The tool, Match Your Medicare, coincides with Medicare’s Open Enrollment period and is set to be available indefinitely. It is free to use, takes no payments from payers or commissions and does not sell or share personal information. 
    • Based on information provided by users, the tool surfaces yearly cost estimates, including premiums, copays and drugs. It also shows what plans in a user’s area keep their docs in-network. Users can compare up to three plans side by side.
    • “MatchYourMedicare.com requires no account and makes no sales calls. Users only need to enter a ZIP code, date of birth and gender. They can also optionally submit their doctors’ prescriptions and health conditions. Additionally, the tool features a video guide that walks users through each step and can help them fill in forms by voice as users speak.”

From the fraud, waste and abuse front

  • Beckers Hospital Review reports,
    • “A top CMS official wants provider suspensions to quadruple in the next six months as part of a broader anti-fraud push that includes new exclusion authority and AI tools, Nextgov/FCW reported Oct. 15.
    • “CMS Deputy Administrator Kimberly Brandt discussed the agency’s enforcement efforts Oct. 15 at the ADAPT conference in Santa Fe, N.M. Ms. Brandt’s slideshow credited the anti-fraud effort with $41.9 billion in fiscal year 2025 savings, up 59% from the year before.
    • “My hope is that suspension number will quadruple over the course of the next six months,” Ms. Brandt said, according to Nextgov/FCW.”

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 elevated nationally.”
  • ABC News reports,
    • “More than 4,400 measles cases have been reported in the U.S., according to an update on Friday from the Centers for Disease Control and Prevention (CDC).
    • “A total of 4,410 cases have been confirmed, with most reported by 45 states and Washington, D.C. Eighteen of this year’s total have been among international visitors to the U.S., according to the CDC.
    • “At least 1,200 of those cases have been reported in Pennsylvania alone by local health officials, as have six measles-related deaths.
    • “It comes as the CDC is planning to send a “disease detective” to Pennsylvania in response to the outbreak.” 
  • STAT News adds,
    • “About 40% of high school students reported binge eating in the past month in a large new government survey, putting a spotlight on how widespread this common form of disordered eating is among young people in the U.S. 
    • “This is the first time the biennial survey, conducted by the Centers for Disease Control and Prevention, has asked about binge eating, and the first data on disordered eating collected by the Youth Risk Behavior Survey in a decade. Among its other striking findings: 17% of nearly 7,000 students said they had engaged in binge eating within the last three days.  “It was extremely alarming seeing how high those numbers were,” said Ariel Beccia, a researcher in the adolescent and children’s medicine division of Boston Children’s Hospital.
    • “Binge eating was more prevalent among female than male students (19% versus 16%). It was also more common among Black (19%), Hispanic (20%), and multiracial (20%) students compared to white (15%) and Middle Eastern or North African students (10%).
    • “The finding that young people of color are largely more likely to report binge eating is important because it counters longstanding stereotypes that eating disorders and disordered eating primarily affect white girls and young women, said Beccia.”  
  • USA Today relates,
    • “Research has shown ultra-processed foods may be the culprit behind rising colon cancer rates − but a new study suggests the type makes a difference.
    • “In the study, published in the journal PLOS Medicine on Oct. 15, researchers found no association between overall ultra-processed food intake and colorectal cancer incidence. Findings differed, however, by type of food.
    • “Higher intake of whole grain and dairy products from ultra-processed food sources was associated with lower colorectal cancer incidence, whereas processed meat from ultra-processed food sources was associated with higher risk, according to the study.
    • “Our findings support current dietary guidance to consume whole grains, fiber, dairy and calcium and avoid processed meat for (colorectal cancer) prevention,” the authors wrote.”
  • Healio adds,
    • “Lower ultra-processed food consumption was associated with reductions in anxiety and depression. 
    • “The crossover pilot trial showed the intervention was feasible and can be expanded in future clinical trials.” 
  • The New York Times tells us,
    • “Doctors are growing increasingly concerned that weight-loss drugs are driving new cases of anorexia, and that few safeguards are in place to protect patients with eating disorders.
    • “Tens of millions of patients now take these medications, which can sometimes cause symptoms that mirror the effects of anorexia: hair loss, dizziness, gastrointestinal issues, extreme calorie deficits.
    • “At that point, it’s like, is that anorexia? Is that disordered eating? Or is that just a side effect of the medication?” said Dr. Katherine Kiley, a family and sports medicine physician in Long Beach, Calif.
    • “Citing an “urgent need” for guidance, an international coalition of obesity medicine specialists, eating disorder clinicians and other experts released new recommendations last month on GLP-1 prescribing and eating disorders. Among their ideas for physicians: Screen all patients for signs of eating disorders before starting a GLP-1, and routinely monitor anyone on the drugs for them.” * * *
    • “Further complicating matters is that many people get the drugs through telehealth services, with little to no oversight from a physician. In a recent study, researchers who tried purchasing weight-loss drugs from 49 websites found that only about one-third required direct interaction with a clinician before prescribing the medications, and only around half asked about eating disorders.”
  • MedScape informs us,
    • “Patients with non-erosive reflux disease (NERD) who took once-daily tegoprazan — a novel, fast-acting, oral potassium-competitive acid blocker (P-CAB) — had a significant reduction in heartburn frequency, a phase III trial showed.
    • “Among patients randomized to placebo or tegoprazan 50 mg or 100 mg, mean percentages of 24‑hour heartburn‑free days through week 4 were 17.3%, 26.2%, and 30.1%, respectively, translating into relative improvements of 51% (P=0.0006) and 74% (P<0.0001) with tegoprazan over placebo, reported Ronnie Fass, MD, of Case Western Reserve University School of Medicine in Cleveland.
    • “Key secondary endpoints of percentages of days without daytime and nighttime heartburn were also significantly improved with tegoprazan, he said at the American College of Gastroenterologyopens in a new tab or window annual meeting in Nashville, Tennessee.”

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

  • Healthcare Dive reports,
    • “The time to start planning for your company’s 2028 health benefits? January of 2027.
    • “That’s according to Marybeth Gray, senior VP of health and welfare benefits consulting with Marsh McLennan Agency. Speaking to a crowd of finance leaders at the CFO Leadership Council’s fall conference in Colorado this week, Gray urged attendees to start thinking about health benefits as soon as feasibly possible.
    • “What might have long been considered strictly an HR issue, Gray said, has firmly become a finance issue.
    • “We need to get on solid footing,” she said, citing data from the Business Group on Health showing that healthcare costs have ticked up as much as 76% over the last decade.”
  • Fierce Pharma relates,
    • “The previous week was rather uneventful for the two oral GLP-1 drugs as Americans geared up for another national holiday, Columbus Day.
    • “Total prescriptions for Novo’s Wegovy pill dipped about 3% sequentially to approximately 173.5K last week. Again, the script number was the result of a compromise between Citi’s reported 173K and Jefferies’ 174K, both referencing IQVIA.
    • “Meanwhile, Lilly’s Foundayo scripts ticked up about 4% to 60,151, still shy of the small molecule’s previous record of 64,268.
    • “In the broader obesity market, Lilly’s Zepbound remained the leader with about 801.8K total scripts, relatively flat week over week. All Wegovy scripts across its injectable and oral forms trended 2.5% downward and landed at about 492.6K, according to Citi.”
  • Beckers Clinical Leadership tells us,
    • “Academic health systems are opening their own longevity medicine programs amid growing demand for preventive care, The New York Times reported Oct. 16.
    • “Since last fall, Los Angeles-based Cedars-Sinai, Chicago-based Northwestern Medicine and New York City-based Weill Cornell Medicine have launched programs aimed at extending health span, or the years a person lives without chronic disease or disability. New York City-based Mount Sinai Health System also expects to open its program this month.
    • “The academic systems’ research entities are playing important roles in shaping these programs. For example, Northwestern’s clinic draws partly on the university’s Potocsnak Longevity Institute, which is studying biomarkers of aging. 
    • “The systems are betting that their research ties will set them apart from the hundreds of private U.S. longevity clinics. Some of those clinics charge thousands to tens of thousands of dollars a year, and many offer screenings and therapies that are not yet proven effective.
    • “The field is still developing, and health systems are drawing different lines on clinical evidence. Northwestern does not offer whole-body MRI, citing a lack of evidence that it lengthens life span, nor does it offer genome sequencing. Meanwhile, Mount Sinai will offer both after patients review the risks and benefits with their physician.”
  • Radiology Business informs us,
    • “Breast imaging startup BeSound is launching its flagship clinic location with plans to eventually scale nationally. 
    • “The company officially opened its newest imaging center in Manhattan on Thursday. Founded in 2023, BeSound offers scanner technology that combines ultrasound with FDA-approved, near-infrared photo-acoustic imaging. It’s focused on targeting the more than 40% of women with dense breasts, whose cancer cases may be missed by traditional mammography.
    • “BeSound is now accepting appointments at its Flatiron District location, with no referral required. The company charges $349 per exam and promises screening results in 48 hours, with pain-free imaging that avoid compression, radiation and contrast dye. 
    • “BeSound said its scans also use proprietary artificial intelligence “designed to help physicians read scans faster, surface findings earlier, and track how a woman’s breast tissue changes over time.”
  • MedTech Dive points out,
    • “MiniMed completed its separation from Medtronic, the companies said Thursday.
    • “The diabetes technology firm, which went public in March, is now independent from its former parent. 
    • “Medtronic began an exchange offer last month to split off a portion of its MiniMed shares. The agreement included a provision where Medtronic could choose to sell all of its remaining shares in MiniMed if the offer is oversubscribed.
    • “Because the offer was 5.4x subscribed, Medtronic chose to exchange all of its remaining interest in MiniMed for shares of Medtronic, the company said Thursday. It no longer holds a stake in MiniMed.”
    • “As an independent company, we have the freedom to make the decisions we believe are right for our business and the people we serve, and the responsibility to see those decisions through,” MiniMed CEO Que Dallara said in a statement. “Our focus now is to put that independence to work and continue advancing what is possible in diabetes care.” 
       
  • Beckers Health IT lets us know about Anthropic’s eight big healthcare moves.

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a DataSpring news release,
    • “The Provider Data Collective, convened by DataSpring, powered by CAQH, today announced a new standard to improve the measurement of provider directory data quality for individual clinicians. It is the first solution from the industry-led coalition bringing together health plans, a health professional organization and an accreditation body to tackle challenges no organization can solve alone. The Collective’s mission is to improve the accuracy and reliability of provider information — clinician data that underpins directories, network operations and other essential health care workflows — so patients, clinicians and health plans can rely on information they trust.
    • Founding organizations of the Collective include Aetna, the American Medical Association, Centene, The Cigna Group, DataSpring, Elevance Health, Horizon Healthcare Services, Inc., Humana, the National Committee for Quality Assurance (NCQA) and UnitedHealthcare. * * *
    • “Inaccurate provider data can create real barriers across healthcare. Patients struggle to confirm whether a clinician is in-network, providers face delays joining networks and seeing patients, and care teams often lack the reliable information needed to coordinate care,” said Tim Kaja, executive vice president of UnitedHealth Group Enterprise Services and board chair of DataSpring. “While CMS established a method to measure provider data accuracy, inconsistent application made it difficult to establish a common baseline for improvement of provider data quality across the industry. The Collective aligned the industry around a shared framework — a more consistent way to measure data quality, identify gaps and track progress.”
    • “The data quality measurement standard creates a foundation for tracking and improving provider data quality across the ecosystem. It also allows this industry-led work to inform regulatory activity as policymakers seek to modernize provider data infrastructures. With that foundation in place, the Collective will next focus on other industry challenges, including how accepting-new-patients status is determined, updated and reflected in directories to improve accuracy and patient access.”
  • Modern Healthcare reports,
    • “The Centers for Medicare and Medicaid Services has gained unprecedented authority to remove providers, insurers and suppliers from federal health programs over fraud concerns.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. published a notice Tuesday announcing he is officially delegating those powers, which had been solely held by the HHS Office of Inspector General, to CMS.”
    • “The two-page document formalizes remarks Kennedy made at a news conference in July. “Both CMS and the Office of Inspector General will be able to use that authority to remove bad actors from federal healthcare programs and, in many cases, permanently ban them from returning,” Kennedy said at the time.
    • “The policy shift gives CMS a significant enforcement tool as the agency toughens up its oversight and fraud detection strategy.”
  • Bloomberg Law adds,
    • “US Health Secretary Robert F. Kennedy Jr.’s proposal to pay doctors to collect information about vaccine injuries drew criticism from medical groups over concerns it would create perverse incentives and a perception of causality not based on evidence.
    • “The idea is one pillar of the Department of Health and Human Services’ new vaccine injury research project formally announced on Thursday, three days after agency leaders secretly met at the National Institutes of Health to pitch it. 
    • “The proposal to compensate Medicare providers was tucked into a wide-ranging physician payment rule expected to be finalized next month as part of an annual rulemaking process.”
  • Beckers Hospital Review relates,
    • “Four House lawmakers, Reps. Rob Bresnahan, R-Pa., Debbie Dingell, D-Mich., Tracey Mann, R-Kan., and Lois Frankel, D-Fla., have introduced bipartisan legislation that would pause HRSA’s 340B rebate model pilot.” * * *
    • “The bill, the 340B Rebate Model Delay Act, would require drugmakers to provide 340B discounts upfront at the time of purchase from Jan. 1, 2027, through Dec. 31, 2028. It would also bar the use of federal funds to implement the rebate pilot or a substantially similar program during that period.
    • “The pause would give Congress time to consider broader 340B reform, including the SECURE 340B Act in the House and the SUSTAIN 340B Act in the Senate, according to an Oct. 9 statementfrom Advocates for Community Health. The group said health centers could be forced to cut services if they have to absorb full drug costs while awaiting rebates.”
  • Per a HRSA news release,
    • “The Health Resources and Services Administration (HRSA) today announced $12.7 million in Fiscal Year 2026 awards through the Maternal Produce Prescription Program (MP3) to help pregnant and postpartum women and their families in low-income and medically underserved communities access healthy foods.
    • “MP3 provides produce prescriptions or vouchers and nutrition education to help pregnant and postpartum women and their families access fruits and vegetables. The program strengthens partnerships among healthcare providers, community-based organizations, and local food systems and aims to increase fruit and vegetable consumption, improve household food security, and improve maternal and birth outcomes.”

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

  • Federal News Network discusses “FEHB and Medicare: Understanding how they work together in retirement.”
  • FedScoop adds, “OPM updates terms of service for USAJobs data following user confusion.
    • “The human capital agency again updated terms for its USAJobs application programming interface to reflect that the data is public and expressly allow analysis.” * * *
    • “In new updated terms released Friday, the agency enshrined its clarifications into its policy.
    • “The terms now state that information from the API is public data and as such, can be “copied, stored, reformatted, adapted, analyzed, published, redistributed, and used for lawful commercial or noncommercial purposes” without prior approval from OPM. 
    • “They also include language protecting analysis, while making it clearer that fraudsters are the target. Under the terms, API users can “modify, summarize, analyze, or combine” the public data, but may not falsely represent the information. ” * * *
    • “In response, the user community cheered the update.”

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

  • CBS News reports,
    • “The Food and Drug Administration received reports in recent months that two people died after taking bootleg versions of an experimental weight-loss drug, according to documents reviewed by CBS News.
    • “The reports link the deaths to products claiming to be retatrutide, a drug being developed by Eli Lilly that hasn’t been approved by the FDA. Federal law prohibits the commercial sale of unapproved drugs, but that hasn’t stopped vendors from selling imitation versions of the experimental drug online at a scale with no modern precedent. 
    • “The cases appear to be the first public accounts in the U.S. alleging that unauthorized use of retatrutide — or products claiming to contain it — played a role in a patient’s death, though the details aren’t verified and it is unclear whether the drug was to blame.” * * *
    • “CBS News was not able to independently verify the information included in the reports, which were obtained under the U.S. Freedom of Information Act and redacted by the agency to remove details that could identify the people mentioned in them. They are part of an emerging picture of potential side effects from a drug that many people are obtaining from unregulated sellers and with minimal to no medical supervision.
    • “America’s Poison Centers, a nonprofit, has tallied a steady increase in reported exposures to retatrutide since it began tracking them late last year, which is common for a newly monitored drug. The centers logged 862 exposures to retatrutide in the three months ending in September, up from 460 in the three months prior and 249 in the first three months of 2026.” * * *
    • “In a statement, Eli Lilly said that the reported deaths “make clear the two individuals were taking black-market retatrutide.” The company said it has found suspect products “with too much, too little, or the wrong active ingredient,” along with contaminants that “can put patients at serious risk.”
    • “Eli Lilly is taking legal action against companies selling bootleg versions of retatrutide, claiming that people will associate bad reactions to them with its product, “poisoning the well for the future of retatrutide medicines.” 
  • DI Cardiology tells us,
    •  “Endovascular Engineering (E2) has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for both the Hēlo Thrombectomy System and Hēlo Return (Blood Return System).
    • “Hēlo, which is a physician-inspired, purpose-built thrombectomy platform for treating pulmonary embolism, leverages a unique design that consistently led to efficient single-pass procedures in the Engulf IDE study. The platform showcased the highest reported clot reduction and the lowest estimated blood loss across all PE Thrombectomy IDE studies.1 
    • “While Engulf provided important clinical validation of the platform’s capabilities, the FDA clearances represent a significant step forward as E2 brings its innovative platform to a broad range of physicians and patients. PE remains a leading cause of cardiovascular death and disability, and there is growing demand for mechanical solutions that support clot removal while reducing procedural complexity and right heart strain.”
  • MassDevice adds,
    • “BridgeSource Medical obtained de novo clearance from the FDA for its handheld cardiac implant identifier, designed to help emergency department clinicians quickly identify a patient’s hardware brand.
    • “According to the Austin, Texas–based company, about half the time a patient enters the ER they don’t know, can’t communicate or aren’t carrying the wallet card listing the specific brand of their pacemaker or implanted defibrillator. This causes delays in triage and treatment — with different approaches being needed for each manufacturer — and clinicians often have to resort to an X-ray to determine the type of device.
    • “BridgeSource’s SmartRead system can be used by frontline healthcare workers to identify an implant within 20 seconds. It works by mimicking the initial communication pings sent by the programming wands from each major implant manufacturer and waiting for a response, including devices from Abbott, Biotronik, Boston Scientific, Medtronic and MicroPort.”

From the public health and medical / Rx research front,

  • JACC offers information about “Cardiovascular Disease Mortality [CVD] by County, Race and/or Ethnic Population, United States, 2000-2019.”
    • “While declining CVD mortality reflects meaningful clinical and public health progress, persistent and pervasive disparities demand solutions-oriented, place-informed research to drive further progress. Critically, these pre-Covid data establish a baseline essential for isolating Covid-era–attributable shifts from preexisting trends. These granular county-level data stratified by CVD cause, race, and/or ethnicity offer a scalable, repeatable framework for agencies to tailor health interventions and rigorously track disparities over time.”
  • Health Day adds,
    • “Monitoring blood pressure at home could help prevent a life-altering injury for some seniors, a new study warns.
    • “Seniors older than 78 with “masked” high blood pressure have a 70% higher risk of falls than those who’ve been properly diagnosed, according to results presented at the American Heart Association’s annual meeting on hypertension.
    • “Researchers said masked high blood pressure involves seniors’ readings appearing normal at a doctor’s office but consistently high at home.
    • “These findings highlight that, in addition to office blood pressure measurement, home blood pressure readings can be an important way to identify hidden home high blood pressure and risk of falls in older adults,” lead investigator Frances Wang said in a news release. She is a researcher at Beth Israel Deaconess Medical Center in Boston.
    • “Changes in blood pressure can increase fall risk by causing dizziness or fainting, according to the American Heart Association (AHA).”
  • Per a National Institutes of Health news release,
    • “A scientific team funded by the National Institutes of Health (NIH) has built a super intelligence (SI)-based interface that enables real-time communication between patients and epilepsy monitoring devices. As part of a small clinical study at the University of Pennsylvania, Philadelphia, patients used a smart-phone application to inquire about their own physiological data and received accurate information in response. Conversely, the system learned from patient feedback to improve seizure detection, ultimately reducing its false alarms by about 80%. 
    • “This proof-of-concept showcases a technology with the exciting potential to shift management of epilepsy and possibly other diseases in a more adaptive direction that puts patients in the driver’s seat,” said Amy Bany Adams, Ph.D., acting director of the NIH’s National Institute of Neurological Disorders and Stroke (NINDS).” 
  • Radiology Business reports,
    • “Alterations in brain connectivity may be associated with anxiety in adolescents, according to new research. 
    • “Published in Imaging Neuroscience, the findings implicate brain circuits connecting the cerebellum, amygdala and thalamus in adolescent anxiety. Experts involved in the study are hopeful that their research could help guide personalized approaches to youth mental health care in the future. 
    • “Precision psychiatry is likely to play an important role in future mental health care,” noted study leader Caterina Stamoulis, PhD, principal investigator in Boston Children’s Computational Neuroscience Laboratory. “In this study, we have identified specific circuits that are implicated in anxiety, which could become the targets of precision interventions to improve short- and longer-term mental health outcomes in youth.” * * *
    • “While the findings are promising and offer scientists a deeper level of understanding of the underlying mechanisms of anxiety disorders in adolescents, additional research will be needed to determine whether the imaging markers can predict individual outcomes or help clinicians select and evaluate targeted interventions. 
    • “Read more here.” 
  • BioPharma Dive relates,
    • “An experimental mRNA cancer immunotherapy from BioNTech failed to delay tumor progression in a late-stage study in a form of head and neck cancer, the company said Tuesday.
    • “According to BioNTech, a combination of its treatment BNT 113 and the widely used drug Keytruda didn’t extend progression-free survival at an interim data check. The trial is testing the dual regimen against Keytruda alone as a first-line treatment in head and neck squamous cell carcinoma that’s driven by a high-risk strain of human papillomavirus. 
    • “A data monitoring committee encouraged BioNTech to continue the trial to determine whether the BNT 113-Keytruda regimen can meet the study’s other main objective by extending survival. Should it do so, BioNTech could still claim success. The early results “support continued evaluation” and show the drug combination is “engaging its intended therapeutic mechanism,” said co-founder and Chief Medical Officer Özlem Türeci.”
  • and
    • “Bristol Myers Squibb said Monday that its experimental lung disease drug admilparant succeeded in a Phase 3 trial in idiopathic pulmonary fibrosis, significantly slowing the decline of study participants’ breathing capacity when compared to a placebo over the course of a year.
    • “However, trial investigators only found a clear benefit among those who received a 60 milligram dose of admilparant. A 120 milligram dose was associated with an impact on disease progression, but the difference didn’t meet the threshold for statistical significance, the company said.
    • “The failure of the high-dose arm is “confounding and requires further explanation,” RBC Capital Markets analyst Trung Huynh wrote in a client note. Bristol Myers previously made certain trial revisions that sparked liver-related safety concerns about admilparant, too, although the company said Monday that the drug “demonstrated a well-tolerated safety profile” and treatment-related study discontinuations were similar between study groups.”

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

  • The Wall Street Journal reports,
    • “UnitedHealth UNH Group reported earnings that came in above analysts’ expectations and again raised its projection for the year, as the healthcare company continued charting a financial turnaround.
    • “The announcement comes more than a year after Chief Executive Stephen Hemsley returned to the top job, promising major changes after a meltdown that cut the company’s valuation by hundreds of billions of dollars.
    • “For the third quarter of 2026, UnitedHealth reported net income of $4.11 billion, or $4.56 a share. That compared with net income of $2.35 billion, or $2.59 a share, a year earlier.” * * *
    • “UnitedHealthcare, the insurance arm, reported a medical-loss ratio of 88.4%, a closely watched number that represents the share of premiums spent on medical costs. The FactSet consensus projection was 89.7%.”
  • and
    • “Johnson & Johnson JNJ is “leaning” toward spinning out the hips-and-knees business that the company has been looking to hive off, Chief Financial Officer Joseph Wolk said.
    • “We think the best value creation at this moment in time for J&J shareholders is to spin it straight out,” Wolk said in an interview. The company talked with private-equity firm Apollo Global Management about a roughly $20 billion sale, The Wall Street Journal has reported.
    • “Wolk made the remarks as J&J said its sales grew a healthy 5.9% in the recent quarter to $25.4 billion, and the company raised its forecast for full-year performance.
    • “Sales of prescription drugs powered J&J’s quarterly results. The company’s medical-device business didn’t grow as much. While acknowledging the medical-device unit needed work, the company said it was on track to surpass $100 billion in yearly sales.
    • “J&J is considered a bellwether for the healthcare industry because its portfolio spans so many different products. Its results show the enduring demand for medical treatment, as other industries grapple with consumers tightening spending because of higher fuel and other costs.”
  • and
    • “Roche ROP Holding struck a deal with China’s Rona Therapeutics to license worldwide rights to an experimental therapy for obesity and metabolic diseases for up to $1.16 billion, moving to bolster its portfolio with a new weight-loss approach.
    • “Under the agreement, Shanghai-based Rona will get upfront and near-term payments of up to $100 million and be eligible to receive an extra $1.06 billion subject to reaching development, regulatory and commercial goals, as well as royalties on potential sales, Rona said Tuesday.
    • “Roche has sought to build and expand a portfolio of weight-loss drugs in recent years, joining a growing group of drugmakers vying to challenge Eli Lilly and Novo Nordisk. It completed in 2024 its $2.7 billion purchase of U.S. obesity drug developer Carmot Therapeutics and entered into an up to $5.3 billion licensing deal with Denmark’s Zealand Pharma to jointly develop a different kind of weight-loss medicine last year.”
  • Beckers Payer Issues relates,
    • “Humana has agreed to form a new joint venture with investment management firm BlackRock to own and operate nearly 150 CenterWell Senior Primary Care clinics, replacing CenterWell’s existing joint ventures with private equity firm Welsh, Carson, Anderson & Stowe. 
    • “Funds and accounts managed by HPS Investment Partners, part of BlackRock, will acquire Welsh Carson’s equity stake, valued at about $2.8 billion, according to an Oct. 13 Humana news release. BlackRock will hold majority ownership, while CenterWell will retain a minority stake and continue managing the clinics.
    • “Unlike the previous agreements, the new deal does not give BlackRock the right to force Humana to buy out its stake. Humana said removing that obligation will significantly reduce liabilities on its balance sheet and lower its cost of capital.
    • “Beginning in 2028, CenterWell can buy clinics from the joint venture, according to the release. If CenterWell has not acquired all of them by the end of 2033, BlackRock can exit through a sale of the remaining clinics, with CenterWell holding the right to make the first offer.”
  • and
    • “Centene will launch its National Performance-Based Gold Card Program in November.
    • “Gold carding aims to streamline prior authorization, reducing requirements for trusted providers. The program will first be available to more than 160,000 qualifying providers across the country for some outpatient services. Eligibility is determined by approval history, documentation quality, medical policy compliance and adherence to regulatory requirements. The insurer anticipates expanding the program to other service types and providers in the future.
    • “Centene COO Susan Smith said the program “was shaped through deep collaboration with providers, ensuring its review process is grounded in the real-world needs of those delivering care every day.” Providers spanning 24 states anonymously contributed feedback to inform the program, according to an Oct. 13 news release.” * * *
    • “In recent years, UnitedHealthcare and Humana have also announced gold card programs. Centene’s update comes as prior authorization reforms pick up steam.”
  • Per a Healthcare Cost Institute news release,
    • “Health care spending for people with employer-sponsored insurance reached $6,743 per person in 2023, according to the nonprofit Health Care Cost Institute’s latest Health
    • “Care Cost and Utilization Report. Per-person spending rose 18.8% from 2019 to 2023, with higher prices, not greater use of care, driving most of the increase.
    • “From 2022 to 2023, spending per person grew 6.5% while utilization was essentially flat. Average prices rose 6.7% that year, continuing a five-year pattern of annual price growth.
    • “Prices are the primary force behind high health care costs,” said Katie Martin, HCCI president and CEO. “Employers, policymakers and other decisionmakers need to focus on price growth to make care more affordable for people and families with job-based coverage.”
  • Beckers Hospital Review tells us,
    • “Hospital margins fell in August as financial pressures mounted and the share of hospitals operating at a loss is growing, according to Kaufman Hall’s [Augut 2026] “National Hospital Flash Report,” released Oct. 13.
    • “The report is based on August 2026 financial performance data from 1,300 hospitals, provided by Strata Decision Technology. The hospitals represent all regions of the country and range from small to large institutions.
    • “The average hospital margin has declined steadily since hitting 5.6% in June. The average fell to 1.8% in August, down from 3.8% in July. The year-to-date average operating margin dropped from 3.8% in July to 2.5% in August.
    • “Mounting financial challenges from increasing bad debt and charity care, payer mix erosion and rising expenses may prompt hospitals to strengthen enterprise margin preservation efforts,” the report said.
    • “About 43% of hospitals are operating in the red, up from 33% before the COVID-19 pandemic. Hospitals have experienced many challenges in the last six years, including staffing shortages, supply cost increases, tech and AI spend and more.”
  • Per a Vizient news release,
    • “The sustained momentum in hospital and health system M&A activity has shown that health systems continue to advance active positioning and portfolio management, with 16 hospital and health system transactions announced in Q3 2026. The 16 announced transactions in Q3 2026 (Figure 1) are on par with what we saw in Q3 2025. As deal volume continued, mega mergers also continued to make waves across the industry. For the third consecutive quarter, multiple mega mergers—transactions in which the smaller party had annual revenue exceeding $1 billion—were announced, along with several transactions that fell just shy of the $1 billion threshold.
    • “The size of these transactions kept the average seller size elevated relative to recent year-end figures, continuing to suggest that M&A activity is increasingly involving larger organizations opting to partner with even larger ones.
    • “Divestitures of specific health system assets represented five of the 16 announced transactions in Q3 2026.”
  • Beckers Payer Issues notes,
    • “CMS’ 2.5% efficiency adjustment cut work relative value units on about 7,700 non-time-based codes starting Jan. 1. It was a percentage cut that came with a conversion factor increase, so the dollar effect is easy to miss. For physicians paid per wRVU, it runs from nothing to more than $13,000 a year, depending on specialty.” * * *
    • “The Medical Group Management Association and consulting firm PYA have flagged procedural and imaging-heavy groups on formula-based wRVU incentives as the most exposed. MGMA also noted exposure for groups whose commercial contracts or benchmarks are tied to wRVU counts.”
  • MedCity News informs us,
    • “Outro, a neuroscience-based platform, announced last week that it raised $7 million in pre-seed and seed funding.
    • “The New York-based company helps patients discontinue psychiatric medications. Patients visit with clinicians trained in safe deprescribing and receive access to personalized tapering plans. They also gain access to compounded medication doses.
    • “Roughly 1 in 6 Americans take antidepressants. There are tens of millions of people on these drugs, yet no science-based way to get off safely. … Outro is the off-ramp that should have been built from the beginning. We want getting off a medication to be as supported as getting on it – arguably even more,” said Brandon Goode, co-founder and CEO of Outro.”
  • Beckers Health IT points out,
    • “The American Medical Association released a governance framework Oct. 13 for agentic AI that takes on clinical functions. The framework says an AI system’s clinical authority must be earned through evidence and maintained through ongoing performance.
    • “The AMA said an AI system’s authority and oversight can change as its evidence, performance, risk or underlying technology changes.”

Holiday Weekend update

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

Happy Columbus Day!

From Washington, DC

  • Congress remains on the campaign trail this week.
  • The Social Security Cost of Living Adjustment will be announced on Wednesday, October 14,
  • Beckers Hospital Review reports,
    • “Health systems told CMS in public comment letters how much its proposed cut to 340B drug payments would cost them, with estimates ranging from about $7 million to $109 million a year [as detailed on the article].
    • “The 2027 outpatient payment rule, proposed July 2, would pay hospitals for drugs bought through the 340B program at average sales price minus 33.4%, down from average sales price plus 6%. CMS estimates the change would cut Original Medicare drug payments by $4.55 billion in the first year. Because the rule must be budget neutral, CMS would raise payments for nondrug outpatient services by 8.44% for all hospitals, including those that do not participate in 340B.

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

  • David Setia, writing in Federal News Network, breaks down why federal employees “should consider retiring after 62, why it just got even more compelling, and how you can make this decision slightly less painful.”
  • FedSmith explains ‘how federal employees can build a financial cushion before the next shutdown.
    • “Federal shutdowns are unpredictable, but financial preparedness isn’t. Here’s how to build a savings cushion before the next funding lapse.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Alignment Healthcare sued federal regulators, alleging that its 2027 Medicare Advantage star ratings were determined “in flagrant violation” of statute.
    • “In the lawsuit filed Friday in District of Columbia federal court, the insurer says that the Centers for Medicare & Medicaid Services “has completely departed from Congress’s vision of leveraging predictable, valid measures developed with input from providers, plans, and the public” in establishing the methodology for the star ratings.
    • “The company argues that rather than establish “consistent, stable specifications” for metrics through the traditional rulemaking process, the agency instead detailed key measures through a series of “technical notes.” This violates the Administrative Procedure Act, per the lawsuit.”
  • Modern Healthcare adds,
    • “The Centers for Medicare and Medicaid Services excluded 20 measures from its 2027 Medicare Advantage star ratings methodology for Clover Health PPOs.
    • “Clover Health successfully sued CMS to get those metrics excluded from its 2026 scores.
    • “Other Medicare Advantage insurers were evaluated on different metrics than Clover Health.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “A 39-year-old unvaccinated woman from Franklin County, Pennsylvania, who had been diagnosed with measles has died, according to the local coroner’s office, marking the sixth such death reported since the state’s outbreak began this year.
    • “The woman’s primary cause of death was a “probable acute cardiac event due to possible complications of the measles,” the coroner’s office said in an emailed statement.
    • “The patient had “a recent history” of having contracted the highly contagious disease, the coroner’s office wrote in a Facebook post, adding that it meets the state health department’s definition of a measles-associated death. The woman had several underlying health conditions and had a “past diagnosis of measles with treatment.”
  • Beckers Clinical Leadership relates,
    • Flu season is off to an early start, with weekly lab-confirmed flu hospitalizations nearly tripling between early September and early October, according to CDC data. 
    • Hospitals reported 3,334 flu admissions in the week ending Oct. 3. That’s up from 2,572 the week before and 1,133 in the week ending Sept. 5. The national admission rate rose to 1.0 per 100,000 people, up from 0.3 in early September.
    • The West is furthest ahead. “California has a full-on flu epidemic right now,” Scott Gottlieb, MD, a former FDA commissioner, said in an interview with CNBC.
  • and
    • “Hospital and health system leaders are grappling with the balance between keeping patients safe and what to do when aging physicians continue to practice amid declining abilities, The Washington Post reported Oct. 12. 
    • “Nearly 47% of the active physician workforce is 55 or older, up from 38% in 2007, and in 2025, 22.4% of physicians are over 65. At older ages, reaction times slow, knowledge can become outdated and some can experience cognitive decline. Mild cognitive impairment increases with age, going from 8.4% in adults 65 to 69, up to 25.3% in adults 80 to 84, according to the American Academy of Neurology.
    • “Studies from Yale New Haven Hospital and Hartford (Conn.) Healthcare found 12.7% to 14.4% of physicians over 70 who were screened showed some degree of cognitive impairment.  
    • “It’s becoming a bigger issue with each passing year,” clinical neuropsychologist Victor Del Bene,PhD, of the University of Alabama at Birmingham, told the Post.”
  • The American Medical Association lets us know “what doctors want patients to know about the common cold.”
    • “Nearly everyone will experience a cold, most often caused by rhinovirus. While there is no cure, there are several ways to manage your symptoms.”
  • Health Day tells us,
    • “Late-night snack may be doing more than affecting your waistline — it could be hurting your liver health.
    • “A few studies have hinted at this idea but this is among the first long-term analyses to explicitly draw the connection to fatty liver disease,” lead author Dr. Robert Wilechansky said in a news release. He’s a hepatologist at Oregon Health & Science University in Portland who specializes in liver transplantation.
    • “Researchers analyzed diet and lifestyle data from nearly 200,000 healthy people who were monitored for about 16 years.
    • “Those who reported eating after dinner or after bedtime had a 36% higher risk of developing non-alcoholic fatty liver disease and a 28% higher risk of cirrhosis.
    • “The results were consistent even after adjusting for factors like age, diabetes status, physical activity and body mass index (BMI), an estimate of body fat based on height and weight.”
  • The Washington Post offers an interview with an oncologist who tells us what to know about DCIS or Stage 0 breast cancer.
    • Experts are starting to question whether identifying ductal carcinoma in situ as cancer leads to unnecessary interventions such as radiation and surgery.
  • The New York Times explains “why ketamine immobilizes some users.”
    • “Potent powders can produce a nearly catatonic state, particularly in those who have not tried the drug before.”
  • and
    • considers whether we ever will understand dementia.
      • “Today dementia is estimated to affect more than 55 million people worldwide, and nearly 10 million cases are added every year. By 2050 — as populations age and the power of diagnosis improves — that number is projected to rise as high as 139 million. We’re already on our way to becoming a society of caregivers, looking after an aging population unable to support itself.
      • “And yet, in a sense, we understand little more about the plaques and tangles of Alzheimer’s disease than we did 120 years ago, when Alois Alzheimer first noticed them. In recent years, we may have even lost ground. A decades-long consensus about the meaning of those plaques and tangles has collapsed as treatments built on those theories have failed, reopening what now must be understood as one of the most urgent unsolved problems in medical science: What is dementia, and how can we possibly slow its advance and reduce its terrible toll?” * * *
      • “A recent overview of the Alzheimer’s literature in the journal Cell offers “hope for a future where AD is not only treatable but also preventable,” while still acknowledging the condition’s “complex pathologic underpinnings.”
      • “This, after all, was Arnold Pick’s insight: that dementia is many things. What if we could nip these complex problems in the bud genetically, before the crippling health care costs and heartbreaking losses — before the ones we love lose much of what makes them who they are?
      • “With the gene carriers, you can get in very early, maybe even before any age-related change is happening, any pathology is present at all,” Dr. Miller said. “I think it’s going to be a really huge decade. We’re just beginning.”
  • Per Genetic Engineering and Biotechnology News,
    • “Domestic dogs offer a useful model for understanding the biology of aging because their lifespans vary dramatically with body size. Large dogs tend to be shorter lived than their smaller counterparts, but why? Headed by a team at Arizona State University, a study of nearly 900 dogs now suggests that the answer may be written into the animals’ epigenomes.
    • “Research professor Noah Snyder-Mackler, PhD, at Arizona State University School of Life Sciences, and colleagues developed an epigenetic clock that predicted mortality in dogs and showed that epigenetic aging is fastest early in life. The study results indicated that male dogs and larger dogs undergo accelerated molecular aging, with male dogs exhibiting pronounced DNA methylation (DNAm) changes on the X chromosome, and larger animals exhibiting methylation changes at transposable elements (TEs), stretches of DNA that can influence genome stability and gene regulation.”
    • “Snyder-Mackler is senior and corresponding author of the researchers’ published paper in Science (“Epigenetic aging and transposon dysregulation reflect size-related lifespan compression in dogs,”) in which they concluded, “Our findings broadly establish companion dogs as a translational model for uncovering molecular mechanisms of lifespan variation, epigenomic instability, and age-related disease.”
  • Per Fierce Pharma,
    • “Mirum pharmaceutical is on a hot streak. On the heels of an FDA approval and a phase 3 win in hepatitis delta, the rare disease company just announced another phase 3 victory for Livmarli, its ileal bile acid transporter (IBAT) inhibitor.
    • “Mirum’s Expand trial tested Livmarli in patients aged 6 months or older with cholestatic pruritus, an intense itch caused by an ultra-rare cholestatic liver disease. The topline readout showed the trial met its primary endpoint achieved significance across all five secondary endpoints.

From the U.S. healthcare business front,

  • Medical Economics reports,
    • “More GLP-1 prescriptions are being filled without ever touching a patient’s insurance, and pharmacists say the shift is accelerating.
    • “Nearly seven in 10 pharmacists (68%) have seen cash-pay GLP-1 transactions increase over the past year, according to a Buzz Health survey of 256 U.S. pharmacists conducted in July 2026. The trend shows up weekly at the pharmacy counter, where patients often pay cash for a GLP-1 while still running their other prescriptions through insurance.
    • “Price isn’t the only factor. More than half of pharmacists say patients have paid cash even when a cheaper or equivalent option was covered by their plan, which suggests convenience and product preference play a role. Pharmacists credit manufacturer direct-to-consumer programs, telehealth pricing and new oral GLP-1s with pulling patients away from their benefits. That is the same growing mix of channels physicians already navigate when patients can’t access the GLP-1 they prescribe.
    • “The shift also creates a data problem. Cash purchases don’t always appear in the claims records that health plans and PBMs use to track utilization and adherence, and most patients don’t realize their insurer can’t see those fills. As online GLP-1 options continue to multiply, that blind spot could make it harder to know what patients are actually taking.”
  • Beckers Hospital Review relates,
    • “Durham, N.C.-based Duke University Health System recorded operating income of $453.1 million (5.4% margin) for fiscal year 2026, compared with operating income of $179 million (2.5% margin) in fiscal 2025, according to its Oct. 5 financial report.”
  • and 
    • “Many large health system layoffs in 2026 feature a common theme: Leadership is cutting corporate and administrative support roles while protecting positions that focus on patient care. It’s a pattern that shows how organizations are deciding what to cut as costs rise and federal policy changes reshape the industry.” * * *
    • “Even while administrative ranks thin, systems are still spending to retain workers. Becker’s has reported that 49 hospitals and health systems have announced plans to raise workers’ pay since December 2025. For example, Hartford (Conn.) HealthCare shared in late September that it will raise its minimum wage to $20 an hour Dec. 27, affecting about 4,000 employees. An additional 4,000 employees will receive pay adjustments to address wage compression resulting from the increase.”
  • Radiology Business tells us,
    • “Siemens Healthineers has officially ceased all sales of its general imaging ultrasound systems. The healthcare giant announced the shift in strategy on Monday, Oct. 12, saying it will now increase its focus on procedural imaging and image-guided therapies. The goal is to build on its strength in cardiovascular imaging, specifically in the areas of intracardiac echocardiography (ICE) and AI, and help care teams perform more complex procedures than ever as technologies continue to evolve. 
    • “Going forward, Siemens Healthineers remains focused on technologies used by electrophysiologists and interventional cardiologists for the detection and management of cardiovascular disease. The company’s Acuson Origin, for example, is a cardiovascular ultrasound system with advanced artificial intelligence (AI) capabilities that first gained U.S. Food and Drug Administration clearance in 2024. The Acuson P500 and Acuson Freestyle systems are also still part of the Siemens Healthineers portfolio.
    • “On the other hand, the company will no longer be selling its Acuson Sequoia, Acuson Redwood, Acuson Juniper or Acuson Maple systems.”
  • Beckers Payer Issues explains why payers have invested in ambulatory surgical centers and lets us know that
    • “Former UnitedHealth Group CEO Sir Andrew Witty has been named chairman of Hatteras Venture Partners, a venture capital firm focused on healthcare innovation, investing across biopharmaceuticals, medical devices and health technology.
    • “Mr. Witty is returning to Hatteras, where he served as a venture partner from 2017 to 2019, according to a Sept. 30 news release from the company.” 
  • Beckers Physician Leadership considers whether any physician can be truly independent.
    • “Independent” has become one of the most loaded words in physician practice. As hospitals, health systems and private equity firms have absorbed practices over the past two decades, the label has come to signal a practice that has stayed outside all three.
    • “Siddharth Tambar, MD, a rheumatologist and physician owner of Chicago Arthritis and Regenerative Medicine, questions how much that label actually describes.
    • “I understand what people mean when they say independent practice, right? That you’re not part of a large either group system, hospital system, PE-owned system,” Dr. Tambar told Becker’s. “So I get that, but realistically, if you are part of the American healthcare system, if you accept insurance, you’re part of these large networks. You’re part of these flows of how patients get to you, and so I don’t think any of us are truly independent in that regard.”
    • “Physicians have little leverage inside those networks. Only 5% of physicians report significant negotiating leverage in private-payer contract talks, and more than 40% report none, according to a Medscape‘s report, “Private-Payer and Government Insurance Report 2026: Medicare, Medicaid, and More,” published Oct. 2.” * * *
    • “Despite continuous shifts in the structures and regulations shaping the physician practice space, Dr. Tambar maintains that strong patient relationships and a desire to stay connected to them is what will keep practices growing in the future — regardless of their independence. 
    • “Long term, obviously, if you’re offering good care to patients, ethical care, that’s how you maintain, right?” he said. “As a physician or as an owner, you have to keep on finding ways to offer value to patients, and whatever treatments are new that can be helpful for the patients, you have to find a way to somehow introduce them and stay relevant and stay present in their minds.”

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.”

Weekend update

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

Simplicity is a virtue.

From Washington, DC

  • Both Houses of Congress have left Capitol Hill for the campaign trail.
  • SCOTUSblog reports,
    • The Supreme Court’s 2026-27 term will officially kick off on Monday [October 5]. The justices will hear argument that morning in two cases: Suncor Energy Inc. v. County Commissioners of Boulder County, on whether a lawsuit filed in Colorado state court seeking to hold energy companies responsible for their alleged role in climate change can go forward, or whether federal law instead bars such claims; and Johnson v. United States Congress, on whether a federal district court may hear a constitutional challenge to a law limiting disability benefits for certain incarcerated veterans.”
  • The Centers for Medicare and Medicaid Services announced last Thursday,
    • Medicare Improvement Fund Premium Rebate Frequently Asked Questions
    • Q: What will the Medicare Improvement Fund do for Medicare beneficiaries? 
    • A: The Administration is making a $90 Premium Rebate available for Part B premiums to certain Medicare beneficiaries because the best way to improve Medicare is to put healthcare dollars back where they belong – in the hands of our Medicare beneficiaries – and make coverage more affordable. 
    • Q: How much is the Medicare Improvement Fund Premium Rebate and when will beneficiaries receive it?
    • A: Eligible beneficiaries will receive one $90 rebate in October 2026. Most beneficiaries will receive a direct deposit for $90 on or around October 8th followed by an email or a letter from the President in mid-October. Some beneficiaries will receive a paper check for $90 from the U.S. Department of the Treasury later in October with the following accompanying message “Medicare Improvement Fund Payment; $90 Payment to Offset October Premium.” 
    • Q: Who will receive the Medicare Improvement Fund Premium Rebate?
    • A: The 20.8 million Americans in Original Medicare Part B who are: (1) Living in the United States, are (2) not receiving premium assistance from Medicaid; or, (3) not paying an Income-Related Monthly Adjustment Amount. Beneficiaries enrolled in Medicare Advantage are not eligible.
  • FEHBlog observation — While the FEHBlog is on Original Medicare Part B and lives in the U.S. he is ineligible for the rebate because he pays an IRMAA fee on top of his Part B premiums. It’s still a good deal.
  • 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 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.
    • “Members of the task force will include Vice President JD Vance, Defense Secretary Pete Hegseth, Richard Walters, White House deputy chief of staff, Bessent, Wiles and others. External participants will include venture capitalists David Sacks, co-chair of the president’s Council of Advisors on Science and Technology and Condoleezza Rice, former Secretary of State in the George W. Bush administration, who will provide advice on national security.”

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

  • My Federal Retirement considers whether “Fraud is driving your FEHB premium increase based on what OPM’s numbers reveal.
    • OPM’s numbers fail to consider that the proper payment rate for the carriers that cover the vast majority of FEHB and PSHB members is 99.9% according to paymentaccuracy.gov and what’s more OPM, not withstanding carrier requests, has not implemented the HIPAA 820 electronic roster transaction which would allow carriers to reconcile premiums with individual enrollee coverage. The HIPAA 820 has been around since 2012.
  • FedSmith reports,
    • “Seven months ago, the OPM retirement backlog stood at a record 65,237 claims. At the end of September 2026, it stood at just 8,814, the lowest total in data going back to January 2012.
    • “September also closed out fiscal year 2026 (FY 2026), which ran from October 2025 through September 2026. It was by far the busiest year in the data for both incoming and completed retirement claims.
    • “New claims received: 179,958, up 59% from FY 2025 (112,857) and well above the previous high of 116,463 in FY 2013
    • “Claims processed: 178,551, up 70% from FY 2025 (104,800)
    • “Backlog: began the year at 23,552, peaked at 65,237 in February, and ended at 8,814
    • “The wave of claims that defined the first half of the year followed the end of the deferred resignation period in September 2025 and broader reductions to the federal workforce. Monthly intake has since settled back toward more typical levels, with fewer than 9,000 new claims in three of the last four months.”
  • FEHBlog observation: The favorable change is attributable to the OPM Director’s implementation of a digital retirement claim system. The HIPAA 820 would similarly reduce the time needed to process premiums and for the first time allow carriers to reconcile premiums with individual enrollments.

No Surprises Act News,

  • The Centers for Medicare and Medicaid Services announced last Friday
    • “On November 1, 2026, the Notice of IDR Initiation web form will include new functionality to enforce certain batching provisions under the Federal IDR Operations Final Rule (final rule).
    • “The new functionality to be added to the Notice of IDR Initiation web form includes:
    • Any batched dispute submitted with an open negotiation period start date on or after November 1, 2026, will be limited to 50 dispute line items.
    • “System validations will enforce the timely initiation of a dispute after a 30-business-day cooling off period by preventing any dispute initiated after the cooling off period from being initiated before the end of the cooling off period or more than 4 business days after the end of the cooling off period.
    • “In addition to the Notice of Initiation web form changes, the payment determination letters will reflect the correct cooling off period based on the dispute type and open negotiation period start date.”
  • CMS Notes:
    • “Batched disputes with an open negotiation period start date before November 1, 2026, will continue to be subject to the 90-calendar-day cooling off period.
    • “Single and bundled disputes will also continue to be subject to the 90-calendar-day cooling off period regardless of the open negotiation period start date.
    • “For disputes subject to a 90-calendar-day cooling off period, disputing parties will continue to have 30 business days after the end of the cooling off period to submit a dispute to the Federal IDR process for any items or services whose open negotiation period expired during the cooling off period.
    • “System validations will continue to prevent any dispute from being initiated before the end of the 90-calendar-day cooling off period.
    • “Furthermore, system validations were added on September 24, 2026, to enforce timely initiation of disputes following a 90-calendar-day cooling off period, preventing any dispute initiated after the cooling off period from being initiated more than 30 business days after the end of the cooling off period.”‘

From the public health and medical research front,

  • The New York Times reports.
    • “The Food and Drug Administration said on Friday that it had found two samples of the cyclospora parasite during its investigation of Taylor Farms facilities in Mexico, strong new evidence that an outbreak that sickened thousands in the United States this summer came from lettuce produced by the company.” * * *
    • “Also on Friday, the F.D.A. announced a series of actions intended to prevent future cyclospora outbreaks. Those included greater surveillance of foods that have caused past outbreaks, which can include cilantro and raspberries, and outreach to growers about how to reduce the risk of produce contamination with the parasite.
    • “It is difficult to know whether those steps will be effective at preventing future outbreaks, since the F.D.A. has not yet determined how the lettuce at Taylor Farms was contaminated, said Jim Gorny, a produce safety expert who retired from the agency in 2024.
    • “Aside from that,” he said, “it’s just a recommitment to employ the same strategies and tactics over and over again hoping for a different outcome.”
    • “Bill Marler, a lawyer based in Washington State whose office represents about 500 people sickened in the outbreak, said there is still more to learn from additional analysis of the samples from the inspection and stool samples of those who fell ill.
    • “But before next growing season, he said, it would be ideal if federal officials could invest in the development of a water test to routinely surveil water for cyclospora, which does not currently exist. He would also like to see officials enforce a federal rule requiring food companies to hand over supply chain records in 24 hours after a product is implicated in an outbreak.
    • “The F.D.A. finalized such a rule but delayed its implementation last year, potentially slowing down the response to this outbreak, The New York Times found.”
  • The Independent relates,
    • “Florida is experiencing its largest dengue outbreak in decades, with 252 locally acquired cases reported as of late September, among the highest totals seen in the continental U.S. in several decades.
    • “The vast majority of cases have been reported in Hillsborough County, home toTampa, where officials are ramping up mosquito-control efforts, according to the latest numbers released by state health officials. Florida has also recorded 245 travel-associated cases this year, while at least 13 Hillsborough County cases involved people who had recently traveled.
    • “The surge has prompted Hillsborough, Pasco and Pinellas counties to declare local states of emergency and step up efforts to kill mosquitoes and eliminate standing water where they breed.” * * *
    • “Dengue is a viral infection spread primarily through bites from infected Aedes aegypti and Aedes albopictus mosquitoes, both of which are found in Florida. Some people have no symptoms, while others can develop a sudden fever, severe headache, pain behind the eyes, muscle and joint pain, nausea or vomiting.
    • “Most people recover, but dengue can sometimes become severe, causing bleeding, shock and death. Florida has reported one dengue-related death this year, involving an elderly Tampa woman who died on September 4.”
  • MedPage Today reminds us,
    • “It’s October and time for flu shots.
    • “Medical experts urge getting a flu vaccination soon, before influenza starts spreading widely — and to get up to date on protection against other fall respiratory viruses, too. Updated COVID-19 shots are available now, plus shots for people especially vulnerable to another winter risk, respiratory syncytial virus (RSV).
    • “While these infections make many people feel miserable for a few days before they recover, every year flu alone causes hundreds of thousands of hospitalizations in the U.S. and kills tens of thousands.”
  • Surprisingly, Health Day informs us,
    • “Colon cancer in U.S. adolescents is on the rise, experts say, and a new report finds it’s typically caught in its more deadly later stages.
    • “Colorectal cancer is, unfortunately, becoming more common in adolescents and young adults and represents a different disease than colorectal cancer diagnosed in older adults,” said study author Dr. Erica Arnold, a pediatric surgery research fellow at Nationwide Children’s Hospital in Columbus, Ohio.
    • “She said colon cancer diagnosed in adolescents “is often aggressive, presenting with late-stage disease and associated with high rates of disease relapse and mortality.” She spoke in a news release from the American Academy of Pediatrics (AAP).” * * *\
    • “The study said symptoms that could indicate colon cancer in young people include unexplained weight loss, rectal bleeding, back/abdominal pain and changes in bowel habits. 
    • “Because colon cancer is so unexpected in this age group, diagnosis is often delayed, the study group warned. 
    • “Children and adolescents without known colorectal cancer predisposition syndromes experience delays in diagnosis and the majority do not have a known family history,” the researchers noted in their study. 
    • “Routine colon cancer screening for people at average risk usually begins at age 45.
    • “The study authors urged physicians to consider this cancer in any young person presenting with symptoms such as abdominal pain or rectal bleeding. 
    • “Because these findings were presented at a medical meeting, they should be considered preliminary until published in a peer-reviewed journal.”

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

  • The New York Times reports,
    • Starting Thursday [October 1], women across the United States will be able to find out their risk of developing breast cancer in the near future with the help of an A.I. tool that examines a single recent mammogram.
    • “Everlywell, a digital health company, announced it would now offer patients nationwide access to Clairity Breast, an A.I. tool approved by the Food and Drug Administration last year to predict a woman’s five-year risk of breast cancer based on imaging. The test, which was previously available only at select locations in Massachusetts and Colorado, will cost $249. It is not covered by insurance.
    • “Doctors use mammograms to detect the presence of cancer, sometimes with the help of A.I. models that can read the images. But Clairity’s software uses the scans for a different purpose: predicting the risk of developing cancer and providing a probability score that reports the patient’s future risk in the form of a percentage, from zero to 100.
    • “That score, which doctors should consider along with other clinical information like family and patient medical history and other risk factors, could aid in efforts to detect cancers earlier, when they are more treatable and more likely to have better outcomes, said Dr. Eleonora Teplinsky, head of breast and gynecologic medical oncology at Valley Health System in Paramus, N.J.”
  • BioEngineer relates,
    • “Sleep problems in children are far more than a nightly nuisance for exhausted families. According to a recent nationally representative study by Carney and colleagues published in the Journal of Clinical Sleep Medicine, sleep disorders among children and adolescents in the United States add an estimated 2.88 billion dollars in health care expenditures every year, a burden significantly higher than that carried by children without sleep disorders.
    • “The finding, highlighted in an open access commentary by pediatric sleep specialist Sally L. Davidson Ward of Children’s Hospital Los Angeles and the Keck School of Medicine of USC, reframes pediatric sleep health as a major economic and public health issue rather than a niche clinical concern. The commentary argues that recognizing, treating, and where possible curing sleep disorders in individual children could simultaneously reduce spending, improve quality of life, boost school attendance, and free parents to work and care for their families.
    • “The underlying evidence comes from the Medical Expenditure Panel Survey, administered by the US Agency for Healthcare Research and Quality, covering the years 2017 through 2022. This survey is unusual in that it captures data from households themselves as well as from their medical providers, including clinics, hospitals, home health agencies, and pharmacies, along with a sample of insurance plans offered by employers. Crucially, the analysis adjusted for covariates and comorbidities that either facilitate or impede access to health care, or that influence the perceived need for care. That methodological rigor matters, because the question of whether sleep disorders drive excess spending, or whether sicker children simply use more services of every kind, is exactly the kind of confounding that national datasets can help untangle when handled carefully.”
  • The Washington Post discusses how to use patient advocates at the time of a family health crisis.
  • Last but certainly not least, AHIP created an illuminating infographic breaking up a dollar bill based on prescription drug spending.
    • “Health plans and PBMs [combined] retain just over one cent of every dollar spent on prescription drugs as profits — compared to 6.5 cents brand manufactures take in profits.”

Cybersecurity Saturday

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

From the frontier AI and Project Glasswing front,

  • OPM’s CIO Adam Starr, writing in the OPM Director’s Secrets of OPM blog, lets us know,
    • “OPM has joined Anthropic’s Project Glasswing and OpenAI’s Daybreak, two industry initiatives that provide cyber defenders with access to advanced AI tools. Early results across Glasswing’s partner organizations are promising — more than 10,000 high- or critical-severity vulnerabilities identified in the first month. OPM will continue to pursue partnerships and capabilities that strengthen our defensive posture and protect the federal workforce data we are entrusted to secure.
    • “That moves the bottleneck. The hard part isn’t finding the hole anymore. It’s patching it.
    • “The flaws attackers are already exploiting have a name: KEVs, for the Known Exploited Vulnerabilities in the Cybersecurity and Infrastructure Security Agency’s catalog. My top security metric at OPM is simple: whether we’ve patched every KEV, and how fast.
    • “Now do that 119 times.
    • “The federal government runs roughly 119 separate HR IT systems. When a vendor ships a critical fix, every agency running that software applies it separately, on its own timeline. An attacker only needs one that’s behind.”
  • Tech Target adds,
    • “When Anthropic introduced Project Glasswing in April, the tech industry braced for impact. Five months in, DevSecOps teams are wading through the glut of discoveries to find out what’s worth patching – and so far, it isn’t much, according to one cybersecurity researcher.
    • “Anthropic updated its Vulnerability Disclosure ledger for the first time in August. A small percentage of initial Mythos vulnerability findings made it into the ledger, and fewer than 1% of the vulnerabilities Mythos found were marked as fixed, according to Patrick Garrity, a security researcher at vulnerability prioritization tool maker Vulncheck.
    • “Garrity and Vulncheck have also been tracking whether vulnerabilities discovered with AI are actually exploited in the wild. This research combined vulnerabilities attributed to Anthropic’s model with data from the Berkeley Vulnerability Research Initiative and correlated them with Vulncheck’s known-exploited vulnerability data.
    • “Of the 1,061 vulnerabilities attributed to AI-assisted discovery, only 14 had been listed as exploited in the wild as of June 2026. That’s roughly 1%.
    • “You discover a vulnerability — that doesn’t mean it’s necessarily useful for an attacker. It doesn’t mean it’s necessarily going to be exploitable with certain conditions,” Garrity said.”
  • The Wall Street Journal relates,
    • “OpenAI says it is scrapping the release of its next-generation AI model over safety concerns that researchers raised during internal testing, in one of the clearest signs so far that agent misbehavior could stymie the industry’s rapid progression.
    • “The move follows a summer punctuated by reports of artificial-intelligence systems industrywide going rogue, and marks a rare case of a major AI developer ditching a new release because of safety concerns.
    • “The company had planned to launch the model, known as GPT-6.1 Astra, in the coming days or weeks, aiming for an October debut. The model was more capable than the company’s previous models in completing challenging tasks from end-to-end without human assistance, as well as writing.
    • “The company instead will focus on improving the safety of future models, which it expects to be even more capable.”
  • and
    • “Nvidia NVDA  launched a software platform to help developers test and deploy artificial-intelligence agents and keep them in a secure environment, ramping up efforts to contain the technology following a string of rogue incidents in recent months.
    • “The chip giant said its Nvidia Open Agent Safety Platform includes tools that let developers continuously monitor and govern AI behavior, ensuring agents follow the rules. Nvidia said the platform included a watchdog that can quarantine agents that attempt to move outside their boundaries in milliseconds, as well as software to enforce what agents can see, do, and interact with.”

From the cybersecurity policy and law enforcement front

  • Beckers Health IT reports,
    • “The Senate passed the bipartisan Health Care Cybersecurity and Resilience Act (S. 3315) by unanimous consent.
    • “The legislation aims to help healthcare providers strengthen their cybersecurity defenses and protect patient information, according to an Oct. 1 news release from the Senate Committee on Health, Education, Labor and Pensions.
    • “Sens. Bill Cassidy, MD, R-La., Maggie Hassan, D-N.H., John Cornyn, R-Texas, and Mark Warner, D-Va., released statements on the Senate’s passage. Sens. Cindy Hyde-Smith, R-Miss., and Angus King, I-Maine, also co-sponsored the bill.
    • “Mr. Cornyn said the legislation would strengthen coordination among federal agencies and improve security practices for rural providers. Ms. Hassan said it would help hospitals and other providers, particularly rural organizations with fewer resources, strengthen cybersecurity and respond faster to attacks.”
  • The Wall Street Journal notes,
    • “President Trump is expected to name Director of National Intelligence Jay Clayton as the new artificial intelligence czar, spearheading AI policy across the administration, according to people familiar with the decision.
    • “The decision isn’t final, the people said, and no official announcement has been made. But the appointment comes as the White House is racing to address the threats posed by the latest models and boost the technology’s popularity. 
    • “Before Clayton was confirmed in July to lead the Office of the Director of National Intelligence, he served as the U.S. attorney for the Southern District of New York. He attended Tuesday’s meeting at the White House with AI leaders including OpenAI President Greg Brockman, Anthropic’s Dario Amodei, and Nvidia CEO Jensen Huang. Afterward, Trump was asked by a reporter if Clayton was under consideration for the role. He responded that Clayton is a “good man” and a “good idea.” CBS News earlier reported the potential appointment.”
  • The Wall Street Journal further relates,
    • “The Federal Trade Commission is investigating Anthropic and OpenAI to determine whether they deceived consumers about the potential harms of their artificial intelligence, the WSJ reports. The agency plans to send civil subpoenas to the two companies in the coming weeks, as well as third-party AI evaluator METR, author of an August report revealing how OpenAI agents secretly collaborated on a message board they built inside OpenAI.
    • “AI CEOs publicly signed White House safety principles alongside President Trump this week, but privately executives like Nvidia’s Jensen Huang pressed Anthropic’s Dario Amodei over his stark public warnings about AI risks, revealing tensions that could complicate the industry’s self-regulation plans, the WSJ reports.”
  • Cyberscoop tells us,
    • “Collaboration with industry is key to balancing AI security risks and benefits, as well as staying ahead of China and other adversarial nations, National Cyber Director Sean Cairncross said Thursday [October 1].
    • “The Trump administration is facing pressure from some quarters of Capitol Hill and even some artificial intelligence executives to establish regulations or embrace legislation to guard against the technology’s risks, something the president himself has rejected.
    • “We’ve never faced a world where our adversaries have the frontier in this space, and so our attempts to optimize that innovation and security is is something that is ongoing, but is increasingly efficient, and it depends on our relationship with industry and our ability to work collaboratively among the the interagency,” Cairncross said at the AI Edge event hosted by The Washington Post.
    • “That collaboration is ever-increasing, he said, such as with the National Institute of Standards and Technology’s Center for Advancing Innovation and Standards for Super Intelligence (CAISSI).
    • “Industry coordination on this, across critical infrastructure sectors, is improving both on industry-to-government and within industry,” he said. “There is collaboration with CAISSI and others as well to do evaluation and testing on these models. That includes work on guardrailing, sandboxing, et cetera.”
  • Cybersecurity Dive points out,
    • Policymakers should fix duplicative and contradictory regulations that currently impede the government’s ability to oversee the cybersecurity of critical infrastructure, industry representatives told the Government Accountability Office during a recent panel discussion.
    • The industry feedback, revealed in a GAO report published on Monday, is the latest evidence that the private sector is deeply unsatisfied with the patchwork of rules governing infrastructure security in the U.S. The new report also comes as the Cybersecurity and Infrastructure Security Agency (CISA) works to finish a congressionally mandated cybersecurity incident reporting rule that could impose sweeping requirements on a broad swath of infrastructure operators.
  • Per a Cybersecurity and Infrastructure Security Agency news release.
    • “The Cybersecurity and Infrastructure Security Agency (CISA) kicks off Cybersecurity Awareness Month today [October 1]. CISA updated our Cybersecurity Awareness Monthpage with additional information, tips, and resources, including for business and government organizations—if you haven’t done so yet, be sure to check out this year’s toolkit.  
    • This year’s theme is Securing the Next 250, highlighting the need for everyone to play their part in strengthening the country’s infrastructure against cyber threats. At a time when nation-state backed cyber threats continue to increase and super intelligence is transforming both threats and security, it is more important than ever that those that own and operate the nation’s critical infrastructure take steps to protect it. 
    • “Whenever critical infrastructure is disrupted, so are the businesses and communities that depend on vital services,” said Acting CISA Director Nick Andersen. “That’s why CISA is prioritizing the security and resilience of critical infrastructure, and state, local, tribal, and territorial government (SLTT), whose systems and services sustain us every day. This includes things like clean water, secure transportation, quality healthcare, secure financial transactions, rapid communications, and more. However great or small—every organization that touches critical infrastructure is vital to ensuring uninterrupted services to America’s communities.” 
  • The American Hospital Association News informs us,
    • “The AHA provided comments Sept. 30 to the Senate Homeland Security and Governmental Affairs Subcommittee on Disaster Management, District of Columbia and Census for a hearing, “Rogue AI: Securing the Homeland Against AI Agent Attacks.” The AHA discussed how it has worked closely with federal agencies to build relationships and channels for the mutual exchange of cyber threat information, risk mitigation practices and resources to implement such practices. The AHA shared information on a rise of cyberattacks in healthcare and increased risk from artificial intelligence tools, the need for federal agencies to protect hospitals and health systems from nation-state-level cyberattacks, and the unique risks rural hospitals face when defending against cyberattacks.”
  • and
    • “The FBI Sept. 29 announced an arrest of one of the alleged leaders of ShinyHunters, a cybercriminal group linked to cyberattacks in the U.S. and internationally on more than 140 organizations, including healthcare, with at least $70 million taken in extortion payments. ShinyHunters has used targeted voice phishing campaigns to deceive personnel into exposing credentials on malicious, medical-themed impersonation domains, Health-ISAC announced in August. ShinyHunters threat actors have been observed contacting employees directly on personal devices through calls, voicemail messages and emails from multiple random accounts.
    • “ShinyHunters is currently one of the most prolific and aggressive cybercriminal groups targeting healthcare and third-party healthcare vendors,” said John Riggi, AHA national advisor for cybersecurity and risk. “They are known for stealing highly sensitive personal information, including health information and extorting victims with threats to publish it. Today’s highly commendable arrest and other recent enforcement actions align with the FBI’s new cyber strategy to impose costs on adversaries, support victims of cybercrime, and join forces with the private sector, including healthcare.”

From the cybersecurity breaches and vulnerabilities front

  • The New York Times reports,
    • “A criminal hacking group known as ShinyHunters revealed last week that it had stolen a vast trove of sensitive personal data from the F.B.I., potentially one of the worst breaches of sensitive government information in the internet age.
    • “The breach may have compromised information about tens of thousands of former and current F.B.I. employees, including data like home addresses, Social Security numbers and even secretive job assignments.
    • “In a series of cryptic statements, ShinyHunters demanded that the F.B.I. retract a public advisory the bureau had issued this springwarning of the group’s cyberattacks. In an email to The New York Times on Friday, ShinyHunters said that the bureau had until the end of Tuesday to fulfill its request. But on Monday, it appeared to walk back that demand, saying it would not publish the data, as it typically does with the information it steals.
    • “In a video posted online on Tuesday, the F.B.I. warned the group that it would aggressively pursue its members as it promoted the recent arrest of a suspect it said was affiliated with the group.”
  • The HIPAA Journal relates,
    • “There has been a 5.9% decline in healthcare breaches compared to H1 2025. Between January 1 and June 30, 2026, 397 data breaches affecting 500 or more individuals were reported to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights – the lowest H1 total since 2023. While the year-over-year reduction in healthcare data breaches is a step in the right direction, healthcare data breaches continue to be reported in high numbers. In the first six months of the year, large healthcare data breaches were reported at a rate of more than 2.2 per day.
    • “Across the 397 reported data breaches, the protected health information of 33.77 million individuals was exposed or impermissibly disclosed. That represents a 22.6% reduction in affected individuals compared to H1 2025, and it is the lowest number of affected individuals in H1 since 2023.”
  • Cybersecurity Dive tells us,
    • “Fortinet on Thursday [October 1] warned of a critical path traversal vulnerability in Fortinet FortiMail, which has been exploited in the wild. 
    • “The zero-day vulnerability, tracked as CVE-2026-104286, allows an unauthenticated attacker to write arbitrary files on a system through the use of specially crafted HTTP or HTTPS requests. 
    • “Fortinet said it has been in touch with government authorities and other stakeholders regarding the threat, and urged customers to apply a workaround. The company did not say when a security patch would be available. 
    • “We are communicating with relevant government organizations, including CISA, on the content of this advisory,” a spokesperson told Cybersecurity Dive.
    • “FortiMail is a platform that provides companies protection from phishing, malware, business email compromise and other potential attacks.”
  • and
    • “Exploitation activity linked to zero-day vulnerabilities in Citrix NetScaler were initially detected on Thursday, days before public disclosure, according to a report Monday [September 28] from GreyNoise. 
    • A malicious cyber actor tried to exploit a zero-day flaw against Citrix NetScaler on Thursday [September 24], according to GreyNoise researchers. At the time, there were no detections available that were specific to this CVE, but researchers labeled the activity malicious. 
    • Two days later, Citrix NetScaler customers began receiving warnings to disconnect their servers due to suspected exploitation activity. By Sunday, Citrix released an official security bulletin warning of multiple vulnerabilities in NetScaler ADC and NetScaler Gateway. 
    • The exploitation activity involved a remote code execution (RCE) vulnerability, tracked as CVE-2026-88771 and a memory overflow vulnerability, tracked as CVE-2026-88772. 
    • Citrix urged customers to immediately patch their systems, warning that successful exploitation could result in RCE, denial of service, HTTP request smuggling and other consequences. 
  • The Cybersecurity Hub Newsletter, posted on LinkedIn, notes,
    • “Dell has released security updates for its Container Storage Modules (CSM) after disclosing vulnerabilities that could allow attackers to take control of infrastructure connecting Kubernetes applications to enterprise storage.
    • “Two flaws carry the maximum CVSS severity score of 10.0. They affect the CSM Authorization module, putting a security component responsible for controlling storage access at the centre of the disclosure. Additional critical vulnerabilities raise concerns about cluster privileges, authentication tokens and sensitive credentials.
    • “The advisory was published on October 1. Dell had not flagged the issues as actively exploited at the time of publication. That distinction matters: the disclosure describes serious opportunities for compromise, but does not establish that customers have already been attacked.
    • “The potential impact deserves attention beyond infrastructure teams. Storage services underpin the availability and integrity of business applications. A failure in the systems governing access to those services can affect several workloads at once, making the scope of a deployment as important to an organisation’s response as the severity score.”

From the ransomware front,

  • Tech Target lets us know that “August’s ransomware activity hit new high for the year.
    • “NCC Group identified 83 ransomware groups active last month, but it said AI wasn’t necessarily what drove the increase in the number of bad actors.”
  • VMblog reports,
    • “Most ransomware defenses rest on a simple assumption: if files look encrypted, you’ve been hit, and if they look normal, you’re safe. New research suggests that assumption is outdated. After detonating 1,064 real ransomware strains in a controlled environment during the first half of 2026, Index Engines’ CyberSense Research Lab found that directory-entry destruction (47.8%) was far more common than full encryption (18.3%). Some strains even scrambled data while leaving filenames, file sizes, timestamps, and entropy untouched, so corrupted files looked perfectly healthy.
    • “To mark Cybersecurity Awareness Month, we spoke with Jim McGann, CMO of Index Engines, about what these findings mean for detection, recovery, and the role of AI in modern attacks. He explains why signature-based detection is losing ground, how quickly damage can spread, and why leaders should move from asking “Do we have backups?” to “Can we prove our recovery data is clean?”
  • Dark Reading tells us,
    • “German authorities have identified a 16-year-old as the alleged mastermind of the KillSec ransomware operation, following a coordinated law enforcement operation that resulted in the arrests of three suspects and searches of eight properties in Spain, Greece, Romania, and the UK.
    • “In an Oct. 1 statement, Hamburg police said investigators also took control of KillSec’s leak website and secured at least 110TB of data to prevent further unauthorized access.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • “Google unveiled its latest AI model, Gemini 4 Argon, with a notice up top that its release would be limited, at least for now, to a list of “trusted cybersecurity vendors.” Such has become the new normal for frontier-model announcements in the post-Mythos age, where touting the guardrails can seem to outweigh posting the wins.
    • “And Gemini 4 Argon, which comes out nearly a year after Gemini 3 enabled the company to leapfrog rivals, clocks some wins. According to the company, the model sets new highs on several coding and knowledge-work benchmarks.
    • “Google says Gemini 4 Argon is already in use inside the company. It has helped quantum computing researchers “optimize the spacetime resources” of certain subroutines and has optimized memory use across its data centers. Argon agents are also migrating C/C++ codebases to Rust across Google.”
  • Beckers Health IT adds,
    • “Google says its new frontier AI model, Gemini 4 Argon, uncovered a critical vulnerability in healthcare software used by hospitals worldwide that put sensitive personal information at risk.
    • “Google-owned cybersecurity company Wiz found the flaw through its Scan for Good initiative, which offers free scanning to find and fix high-risk exposures at organizations that run critical public infrastructure. Koray Kavukcuoglu, senior vice president of Google DeepMind and chief AI architect at Google, described the finding in a Sept. 30 blog post. Mr. Kavukcuoglu said earlier frontier models had missed the risk.
    • “Google did not name the software or its vendor. It also did not say what specific data was at risk or whether the vulnerability has been patched.
    • “Wiz said Sept. 24 that Scan for Good, using Google’s Gemini 3.8 Flash Cyber model, had found exposures at two unnamed hospitals, which it said were fixed before disclosure. Google did not say whether the Argon finding is related to either case.”
  • The New York Times relates,
    • “Epic Systems, the nation’s largest medical records vendor that is relied on by thousands of hospitals and doctors’ offices, is using artificial intelligence tools to patch security risks that could give hackers undetectable access to patient health data, company officials said.
    • “The unusual nature of the vulnerability and the urgency to fix it prompted Epic to slow down development of some product lines while it sent engineers into a sprint to patch security holes.
    • “Judy Faulkner, Epic’s chief executive, revealed the security weakness and a six-week plan to shore up the gaps at an industry conference last week, but most details about the danger have not previously been reported.
    • “You worry that after a month and a half of working almost primarily on safeguarding the software, that new things will be created by those who are trying to bust the software, and it will be in a never-ending cycle,” Ms. Faulkner said.
    • “According to company representatives, Epic deployed Anthropic’s Claude Mythos artificial intelligence agent to stress-test its systems, to hunt for ways that hackers could unleash open-source A.I. agents and unlock confidential patient records.
    • “The security weaknesses pose a particularly acute threat for Epic, which maintains records of 325 million patients in the United States and other countries.
    • “And it underscores the competing forces surrounding the ever-expanding uses of artificial intelligence in health care.”
  • Cyberscoop informs us,
    • “OpenAI said it disrupted a “coordinated campaign” to distill and extract reasoning capabilities from its AI models, pointing the finger at a Chinese rival.
    • “On Wednesday [September 30], OpenAI said it first spotted low-level activity on July 1 that gradually increased until July 24 and 25, when it observed 16,000 prompts from 4,000 users that fit a similar “relevant extraction pattern.” The number of suspicious users had climbed to 15,000 by July 28, when OpenAI said it “fully disrupted” the operation.
    • “The company called the attackers’ method “novel.” They copied encrypted reasoning data from one conversation, then asked the model in a separate conversation to decrypt the content and transcribe it in plain text. Outside researchers reported a similar vulnerability to OpenAI in August.
    • “The operators did not break our encryption, compromise a database, or gain direct access to stored user conversations,” OpenAI wrote in an unsigned blog post. “Instead, they manipulated model interactions so that protected reasoning could be reproduced in forms visible to the requester in a coordinated, scaled manner that violated our terms of service.”
  • Cybersecurity Dive tells us,
    • “Businesses need to prepare for the ways in which AI is changing the cyberattack landscape, Microsoft warned on Thursday [October 1].
    • “AI is speeding up attacks, making advanced techniques easier and putting stress on systems that organizations have long overlooked, the company said in its annual Digital Defense Report.
    • “The report also describes nation-state and cybercrime threat actors’ most significant activity from the past year, including their targets and motivations.”
  • The Wall Street Journal points out,
    • “Cybersecurity startup Armadin has raised $255.5 million to boost its force of AI agents trained to find security flaws cybercriminals are most likely to exploit—in part by attacking customers with swarms of autonomous hackers.
    • “Total funding for Armadin, which security veteran Kevin Mandia founded a year ago, is now $445 million. The company’s market valuation tops $2.5 billion. More here from my colleague Angus Loten.”
  • Here is a link to Dark Reading’s CISO Corner