Monday report

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Monday report

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

Simplicity is a virtue.

From Washington, DC

  • Beckers Payer Issues reports,
    • “The Trump administration is overhauling federal price transparency rules for payers and self-insured employers, including cutting so-called “ghost rates,” expanding out-of-network price disclosures and requiring executives to vouch for the accuracy of the data.
    • “The final rule, released Oct. 5 by CMS and the Labor and Treasury departments, revises the price transparency regulations first finalized in 2020 during President Trump’s first term, which have required payers to post their negotiated rates since 2022. Hospitals have been required to post their prices under separate federal rules since 2021. The new rule takes effect Dec. 5, though most of the data requirements will be phased in across 2027. 
    • The change follows a CMS proposal and an executive order from the president last year that directed federal agencies to step up price transparency enforcement.”
  • The rule is applicable to the FEHB and PSHBP programs pursuant to the Public Health Act, which CMS regulates.
  • Here is a CMS link to the agency’s fact sheet on the new TiC rule.
  • Also today, CMS released an update to its Group Health Plan user guide for Section 111 reporting.
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Michael R. Caputo to the President’s Cancer Panel. The panel is an independent federal advisory body charged with monitoring the development and execution of the activities of the National Cancer Program and reporting to the President on progress, efficacy, and opportunities for improvement in the national effort against cancer. The Panel was established by law through the National Cancer Act of 1971.
    • “Caputo brings 35 years of global public affairs experience spanning government, public policy, political campaigns, and the private sector. He previously served as Assistant Secretary for Public Affairs at HHS in 2020, where he led the Department’s communications during the COVID-19 response and helped establish and guide Operation Warp Speed.”
  • Beckers Hospital Review lets us know,
    • “Healthcare accounted for about 3 of every 4 U.S. jobs added from September 2025 to September 2026, according to an Oct. 5 analysis from the Peterson-KFF Health System Tracker.
    • “The sector added 372,000 jobs during that period, a 2% increase, while the rest of the economy added 124,000, a 0.1% increase. Healthcare job growth outpaced every other sector, and the industry now makes up a record 11.7% of all U.S. jobs.
    • “In September, healthcare added 17,000 jobs, below its average monthly gain of 33,000 over the prior 12 months, according to Bureau of Labor Statistics data.”
  • and
    • “The Federal Trade Commission has warned 24 of the nation’s largest health systems that incomplete, inaccurate or untimely price disclosures could violate federal consumer protection law, even if the organizations comply with CMS’ hospital price transparency requirements.
    • “FTC Chair Andrew Ferguson on Oct. 5 sent letters to the organizations urging them to review their pricing practices and take corrective action where needed, particularly for routine, nonemergency services scheduled in advance.
    • “The letters mark another layer of federal scrutiny for hospitals’ pricing practices. The FTC said CMS’ price transparency rules establish a baseline for disclosures but do not provide hospitals with a “safe harbor” from liability under Section 5 of the FTC Act, which prohibits unfair or deceptive business practices.”
  • MedTech Dive adds,
    • “The Advanced Research Projects Agency for Health has awarded more than $100 million to four organizations working on biosensors.
    • “The Massachusetts Institute of Technology received the largest award, securing up to $37.9 million to develop a wearable patch for continuous sensing of heart failure biomarkers.
    • “The other recipients include Novelna, New York University and University of Washington, which are working on devices focused on heart attacks, inflammation and perimenopause. ARPA-H said it plans to commit a total of $117.4 million to the program over 4.5 years.”

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

  • Kevin Moss, writing in Federal News Network, explains “how the 2027 FEHB premium increase will impact federal employees and annuitants.”
  • FedSmith offers a potpourri of Open Season news.
    • “2027 FEHB Changes: Weight Loss Drug Rules, a New FSA Card, and Plans Leaving
    • “From weight loss drug rules to a new FSA card and plans leaving the program, here are the biggest 2027 FEHB changes to know before Open Season.” * * *
    • “Full FEHB, PSHB, and FEDVIP plan brochures and OPM’s Plan Comparison Tool will be available on OPM.gov in early November.
    • “Open Season changes for non-postal employees take effect January 10, 2027. Changes for PSHB enrollees and annuitants take effect January 1, 2027.”

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

  • ABC News reports,
    • “More than 122,000 cases of Gatorade are being voluntarily recalled due to undeclared food dyes, according to the U.S. Food and Drug Administration.
    • “The recalled cases of Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange and Gatorade Orange Zero were distributed in more than two dozen states, the FDA said.
    • “The recall impacts 28-ounce bottles of Gatorade Lemon Lime, Lemon Lime Zero, Orange, and Orange Zero that did not declare the presence of Yellow No. 6 and/or Yellow No. 5 colors and bear lot dates between April 2027, May 2027 and June 2027. A full list of lot dates and states where the recalled drinks were distributed can be viewed on the FDA website.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches. The RFI seeks comments, data, and information on specific protocol elements relevant to ibogaine drug development, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight.
    • “This RFI marks the latest FDA action to advance President Trump’s April 2026 executive order on Accelerating Medical Treatments for Serious Mental Illness, which directed agencies to accelerate research into psychedelic medicine.” * * *
    • “The public will have 45 days following publication in the Federal Register to submit comments, data or information to the docket. Stakeholders are encouraged to submit comments electronically at regulations.gov by searching for Docket No. FDA-2026-N-10429. Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    • “The comment period closes Friday, November 20, 2026. Late comments will not be considered.”
  • Becker’s Hospital Review relates,
    • “The FDA has approved pirtobrutinib (Jaypirca, Eli Lilly) for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion.
    • T”he Oct. 2 approval was based on BRUIN CLL-313, a trial involving 282 patients randomized 1:1 to receive pirtobrutinib or bendamustine plus a rituximab product for six cycles.
    • With an estimated median follow-up of 28 months, median progression-free survival was not estimable in the pirtobrutinib arm and was 33.5 months in the bendamustine and rituximab arm.
    • Serious adverse reactions occurred in 28% of patients taking pirtobrutinib. The most common nonlaboratory adverse reactions were upper respiratory tract infections (27%), rash (22%) and COVID-19 (21%). The recommended pirtobrutinib dose is 200 milligrams orally once daily until disease progression or unacceptable toxicity. The drug received orphan drug designation.
  • Radiology Business tells us,
    • “The U.S. Food and Drug Administration has cleared AI software designed to improve pediatric bone age assessments. 
    • “The 510(k) clearance covers Visiana’s BoneXpert, a machine learning software that determines bone age in patients ages 2 to 21 using the Greulich-Pyle method. The software is intended to support pediatric radiologists in evaluating children with growth and pubertal disorders. 
    • “Bone age assessments are commonly used to evaluate whether a child’s skeletal development is consistent with their chronological age. Manual assessment is a known challenge and can vary between readers, potentially making longitudinal evaluation more difficult.  
    • “BoneXpert addresses this by analyzing radiographs of either hand and providing an annotated image showing the contours of the bones it evaluated and the individual bone ages assigned to them. The software also checks each radiograph and withholds a result when an image falls outside its validated scope, while the radiologist remains responsible for the final assessment and diagnostic decision.” 
  • Benzinga adds,
    • “The U.S. Food and Drug Administration has extended its review of Novo Nordisk A/S’ (NYSE:NVO) Biologics License Application for denecimig, an investigational hemophilia A treatment, following a manufacturing plant inspection.
    • “Mike Doustdar, president and CEO of Novo Nordisk, said the company is addressing agency requests as efficiently as possible while working closely with regulators to make better care something patients can count on.”

From the Medicare Advantage front,

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. has cut its Medicare Advantage footprint in half less than two years after buying Cigna’s Medicare business for $3.3 billion, but the Chicago-based insurer says the narrowed focus will allow it to achieve sustainable growth over time.
    • “The company is coming off a costly year, posting a net loss of more than $1.9 billion in 2025, after net income of $659 million the year prior. HCSC attributed the loss to elevated utilization and higher acuity across all of its lines of business.
    • “We’re actually at or ahead of most of the targets we set before the deal closed, from an integration and financial performance perspective,” Stephen Harris, president of government markets at HCSC, told Becker’s. “We feel really good about where we are and the momentum we have going into 2027.”

From the judicial front,

  • Fierce Healthcare offers a overview of “healthcare’s high-stakes courtroom battles.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Pennsylvania’s measles outbreak has hit a sobering milestone, surpassing 1,000 cases — the first U.S. outbreak to do so in 35 years.
    • “In Pennsylvania, the virus has moved through communities where many children and adults have gone years without the two doses of measles vaccine needed for reliable protection. The widening outbreak has infected 1,004 people spread across 39 counties and hospitalized nearly 200 people, authorities reported Monday.”
  • The New York Times adds,
    • “Gov. Kathy Hochul declared a statewide health emergency in New York State on Monday as measles cases increased dangerously across rural counties where vaccination rates have lagged.
    • “As of Saturday, 108 measles cases had been reported across the state this year, the most since 2019, when New York was the epicenter of a national outbreak. Most of the cases are in rural areas, concentrated in the Finger Lakes region.
    • “Ms. Hochul’s declaration will relax rules about who can administer vaccines to make it easier for midwives, pharmacists and other health care workers to give shots to prevent measles.”
  • NBC News relates,
    • “The chickenpox vaccine appears to protect against shingles, according to a large new analysis. 
    • “Anyone who got infected with chickenpox as a child is at risk of later developing shingles, a painful, blistering rash that usually appears on one side of the body. For unknown reasons, cases of shingles have been gradually rising, even among younger adults, research has shown.
    • “However, new data suggests that a steep decline in chickenpox cases over the last three decades, thanks to the chickenpox vaccine, may contribute to a decline in shingles in the coming years.
    • “New data suggests that people ages 34 and younger may be less likely to develop shingles than previous generations. That’s because they are more likely to have been vaccinated against the varicella zoster virus, or chickenpox, which can reactivate years later as shingles.
    • “Our data suggest that trend is now reversing in the very youngest adults, the first generation eligible to be vaccinated against chickenpox as children,” said registered nurse Kersten Bartelt, lead author of the report from Epic Research, which conducts research on health trends.”
  • MedPage Today tells us,
    • “Hormone therapy should be the first-line treatment for women with menopausal vasomotor symptoms, according to new guidance from the American College of Physicians (ACP).
    • “Women with a uterus should receive estrogen in combination with progestogen, while those without a uterus can receive estrogen monotherapy as first-line therapy, according to ACP’s new clinical guidelineopens in a new tab or windowon pharmacologic treatments for vasomotor symptoms.
    • “Both are listed as strong recommendations based on high-certainty evidence, Amir Qaseem, MD, PhD, MHA, and guideline authors wrote in the Annals of Internal Medicine.”
  • Beckers Behavioral Health calls attention to “the drug trends mot worrying to behavioral health leaders.”
    • “Fentanyl is no longer the only substance keeping addiction clinicians up at night. Some of the newest threats are being sold not by dealers, but at gas stations, smoke shops and online.
    • “From potent animal sedatives contaminating the opioid supply in the Northeast and Midwest to concentrated kratom derivatives marketed as botanical supplements, the substances patients are using are changing faster than the systems built to respond to them. At the same time, technology is making behavioral addictions such as online sports betting more accessible than ever. 
    • “Becker’s asked three psychiatry and addiction medicine leaders what trends they are seeing among their patients, which drugs they expect to take off and what worries them most.”
  • Cardiovascular Business informs us,
    • “Orforglipron, a GLP-1 pill being sold by Eli Lilly and Company under the brand name Foundayo, is both safe and effective in obese or overweight patients with type 2 diabetes. That was the primary takeaway from new data presented at the European Association for the Study of Diabetes annual meeting in Milan, Italy, and simultaneously published in The Lancet.[1]
    • “In April, the U.S. Food and Drug Administration (FDA) approved orforglipron as a once-daily treatment for weight-related medical problems in obese and overweight adults. When the FDA requested additional data on the drug’s effect on cardiovascular outcomes, Lilly shared early positive results from ACHIEVE-4, a randomized trial of more than 2,700 patients who received either orforglipron or insulin glargine. Now, the full results of that analysis have been shared with the public for the first time.
    • “Overall, the researchers behind ACHIEVE-4 found that orforglipron was associated was a 16% lower risk of major adverse cardiovascular events (MACEs) than insulin glargine. A MACE was defined as either cardiovascular death, a heart attack, a stroke or a hospitalization for unstable chest pain. This finding met the prespecified criteria to be seen as noninferior to insulin glargine.”
  • BioPharma Dive points out,
    • “An experimental pneumococcal vaccine from Vaxcyte succeeded in the first of three late-stage studies, sending the biotechnology company’s shares soaring and inching it closer to a potential regulatory submission.
    • “Called VAX-31, the shot met all of its main efficacy objectives in the study. Among adults 50 years or older, VAX-31 matched the effectiveness of Pfizer’s Prevnar 20 and Merck & Co.’s Capvaxive in protecting against 28 strains of the bacteria that causes pneumococcal disease and proved superior against three “unique” strains. VAX-31 was inferior compared to Capvaxive on two strains when using a more rigorous statistical threshold. But that finding surpassed analyst and investor expectations heading into the readout.
    • “Vaxcyte said its vaccine was “well tolerated” and demonstrated a safety profile similar to Prevnar 20 and Capvaxive across all ages studied. The most common adverse events were “generally mild-to-moderate,” and the majority resolved within two days of vaccination. Vaxcyte will report results from two additional late-stage trials next year and seek approval if the data are positive.”

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

  • STAT News reports,
    • “Workers and employers are drowning in their health insurance premiums. The reason for that deluge: the health care industry’s high and inscrutable prices.
    • “Health insurers don’t set their premiums in a vacuum. The biggest factor is the care people receive. And the biggest factor driving the cost of that care, STAT has found, is not how often people are going to the hospital or doctor’s office, but the out-of-control prices charged by every part of the health care industry, which workers and businesses are often powerless to stop.
    • “For Gerard Anderson, America’s high prices are as obvious, yet unnoticeable, as the oxygen we breathe. He has studied health care spending and policy for the past four decades, even helping design Medicare’s hospital payment system in the 1980s. He co-wrote a seminal paper in 2003, and again in 2019, that blared the culprit of America’s outlier health spending figures: “It’s the prices, stupid.” 
    • “Some things don’t change,” Anderson, a professor at Johns Hopkins, told STAT. 
    • “One thing is changing, however, Anderson said. He and others are working with state policymakers and employers, who are signaling an openness to government intervention to curb health care costs — an idea normally anathema in the private sector.”
  • BioPharma Dive relates,
    • “Shionogi is expanding in rare diseases, announcing Monday a deal to acquire Texas-based IntraBio for a drug called Aqneursa that has gained approvals in two inherited disorders.
    • “Per deal terms, Shionogi will pay IntraBio’s shareholders $2 billion in cash and turn the company into a wholly owned subsidiary of its New Jersey-headquartered U.S. division. Shionogi said it will review the transaction’s effects on its financial outlook for the current fiscal year, which ends next March.
    • “The transaction will help expand a rare disease business Shionogi launched with the acquisition last year of the ALS drug Radicava from Tanabe Pharma. Aside from Radicava, Shionogi’s U.S. portfolio includes the COVID-19 medicine Xocova and a treatment for complicated urinary tract and hospital acquired respiratory infections.”
  • The Wall Street Journal adds,
    • “GE HealthCare Technologies GEHC said Monday it planned to purchase a manufacturer of radioactive substances used in medical imaging procedures for $945 million in cash.
    • “The deal marks a continued push by medical-equipment maker GE HealthCare into the growing market for radiopharmaceuticals, which have uses for both diagnosing and treating diseases including cancer, heart disease and Alzheimer’s. 
    • “Drugmakers such as Novartis and other devicemakers have been investing in the segment. In August, Curium struck a deal to acquire Lantheus Holdings for an initial $6.7 billion in a consolidation of two radiopharma companies.”
  • Beckers Hospital Review tells us,
    • “Chicago-based CommonSpirit Health will consolidate its five regions into three service areas, West, Central and East, effective in January, CFO Michael Browning said during the system’s fiscal 2026 earnings call Oct. 2.
    • “The change replaces the California, Central, South, Mountain and Northwest regions established after a 2024 portfolio review that consolidated eight operating divisions into five. Each service area president will sit on the system’s enterprise leadership cabinet.
    • “CommonSpirit confirmed in a September statement to Becker’s that it was evolving its operating model “to better leverage our system scale and more effectively support our markets.”
  • and
    • “Salt Lake City-based Intermountain Health is exiting Trinsic, a Colorado clinically integrated network it operates as a joint venture with Aurora, Colo.-based UCHealth, with UCHealth taking over the network after Dec. 7, according to a WARN notice Intermountain filed Oct. 2 with the Colorado Department of Labor and Employment.
    • “The notice says Trinsic’s Broomfield, Colo., operating unit will close Dec. 4 and 117 employees will be affected, with first separations expected Dec. 9. Affected roles include 29 nurse care managers, 24 clinical care coordinators and 14 nonclinical care coordinators.
    • “Intermountain said in the notice that it expects most, if not all, Trinsic employees who live and work in Colorado will have the opportunity to keep working for Trinsic, subject to UCHealth’s hiring decisions. Employees who live and work outside Colorado may not have the same opportunity.”
  • Fierce Healthcare informs us,
    • ‘Trinity Health grew its operating income from a narrow loss to a $281.1 million gain (1.1% operating margin) in the fiscal year ended June 30, 2026, a performance improvement the large nonprofit attributed to stronger volumes, expense management and payment rates. 
    • “Operating revenue across the organization rose 5.2% year over year to $26.8 billion, outpacing a 4.4% rise in operating expenses, according to recently shared financial documents. 
    • “When disregarding “other items” including asset impairment charges ($42.7 million in FY2026) and restructuring costs ($103.9 million in FY2026), the 91-hospital system more than doubled its operating income to $427.8 million (1.6% operating margin) in the fiscal year ended June 30, 2026, its management touted in a financial summary.”
  • and
    • “iRhythm completed on Monday its acquisition of cardiac remote patient monitoring company VitalConnect for $237.5 million.
    • “iRhythm provides end-to-end cardiac monitoring services, while VitalConnect’s monitoring platform supports multiple modalities—and has the capability to monitor up to 11 physiological parameters, according to an Oct. 5 press release.
    • “In addition to the $237.5 million deal, iRhythm provided VitalConnect with $10 million in working capital between signing and closing, executives say. The acquisition is expected to increase iRhythm’s revenue growth rate and maintain its 15% adjusted EBITDA margin target for 2027.”
  • and
    • “Grindr is ramping up its focus on healthcare with plans to acquire PurposeMed Inc., the parent company of telehealth provider Freddie.
    • “Freddie provides access to HIV prevention and PrEP care through telehealth visits. Grindr plans to pick up PurposeMed for $250 million in cash and stock, consisting of $190 million in cash and $60 million in Grindr common stock. 
    • “The agreement also includes the potential for up to $70 million in additional cash consideration tied to 2027 performance targets, payable in 2028. The companies expect the deal to close in the fourth quarter, subject to applicable closing conditions.”
  • Beckers Clinical Leadership points out the ten most in-demand physician specialties.
    • “Hematology/oncology
    • “Gastroenterology
    • “Cardiology (interventional)
    • “Endocrinology
    • “Cardiology (noninvasive)
    • “Radiology
    • “Urology
    • “Anesthesiology
    • “Neurology
    • “Obstetrics/gynecology
      • View the full report here.

From the Nobel Prize front,

  • The Wall Street Journal reports,
    • “A trio of neuroscientists were awarded the 2026 Nobel Prize in Physiology or Medicine for their pioneering work on optogenetics, a method of controlling nerve cells with light, which makes it possible to study how the brain shapes memories, feelings and behaviors.
    • “Announcing the prize recipients Monday at the Karolinska Institute in Stockholm, the Nobel committee said the work of Drs. Karl Deisseroth, Peter Hegemann and Georg Nagel had laid the foundation of a new era in neuroscience.
    • “The work “unlocked new understanding of how the brain works, new possibilities for treating neurological and psychiatric disorders,” said Jonathan Levin, president of Stanford University, where Deisseroth is a neuroscientist and psychiatrist. 
    • “Hegemann is based at Humboldt University in Berlin and Nagel at the University of Würzburg in Germany.”

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

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, SCOTUS, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • AHIP reports,
    • “The House Ways and Means Committee’s recent advancement of the Apples to Apples Comparison Act (H.R. 4093) signals policymakers recognize the growing need for more accurate data and assessments comparing Medicare Advantage (MA) and fee-for-service (FFS) Medicare. If enacted, this legislation would require Medicare to report more complete expenditure data and direct the Medicare Payment Advisory Commission (MedPAC) to compare MA and FFS using a more transparent and reliable methodology. 
    • “Key Context: Accurate and reliable analyses are essential to understanding how MA compares to FFS. It requires accounting for key differences between the programs – including the benefits provided within MA, different enrollment requirements, and demographics and health characteristics among MA enrollees. 
    • “A growing body of research points to significant questions and concerns with MedPAC’s current approach to comparing spending in MA and FFS, including its estimates of alleged favorable selection into MA and failure to account for the key programmatic, enrollment, and other differences.
    • “The Apples to Apples Comparison Act would address these concerns and ensure that policymakers have the information needed to accurately assess both programs.
    • “Why It Matters: Accurate comparisons between MA and FFS show that MA provides better care at lower costs than FFS. With 36 million American seniors and people living with disabilities choosing MA, policymakers should ensure they protect and strengthen MA for the seniors who count on it.”
  • Beckers Behavioral Health relates,
    • “HHS will provide $96 million over four years to eight communities through its new Safety Through Recovery, Engagement, and Evidence-based Treatment and Support program.
    • “The funding will help communities build coordinated systems of care for people who are homeless and have serious mental illness, substance use disorders or co-occurring disorders.
    • “The program combines street-based engagement and treatment with recovery supports, housing and other community services.
    • “The Substance Abuse and Mental Health Services Administration will administer the STREETS program, according to an Oct. 2 news release from HHS. Each selected community will receive $3 million a year for four years.”
  • and
    • “The 988 Suicide & Crisis Lifeline has brought back specialized crisis support for LGBTQ+ youth through its “Press 3” option, with the service available again starting Sept. 30, the Los Angeles Times reported Oct. 1.
    • “Launched in 2022 in partnership with the Trevor Project, the option connects callers and texters directly with counselors trained to support young LGBTQ+ people. The service was suspended in July 2025 after the Substance Abuse and Mental Health Services Administration said it would “no longer silo LGB+ youth services” from the general hotline.”
  • STAT News tells us,
    • “Finding information from the National Institutes of Health about human health, disease, and biomedical research is about to look a lot different. On Monday, the NIH will unveil a new version of its website that shifts attention away from individual institutes and centers and towards eight thematic hubs focused on health, research, data, clinical studies, rare diseases, technology, cancer, and grants.
    • “Agency officials say the redesign — which is part of an ambitious project to consolidate the NIH’s digital footprint — is intended to streamline what was a sprawling and fractured information ecosystem, requiring users to understand NIH’s organizational structure, into an intuitive experience that more closely reflects what type of information people seek out most often.
    • “The goal, said NIH deputy director for public affairs, Amanda Fine, is “to make trusted NIH information across the agency easier and faster to find.”
    • “The beta version, which was soft-launched this week, is still under development and will continue to evolve in the coming months, NIH officials told STAT. Some functions, including search, do not yet appear to be operational. During this transition period, NIH’s existing websites will continue to remain available, and they will sunset on a rolling basis “as critical and mandated content is verified and redirects are put in place,” Fine told STAT.” 

From the Medicare Advantage front,

  • Beckers Hospital Review reports,
    • “SCAN Health Plan and Costco shared Oct. 1 that their co-branded Medicare Advantage plans will go live in California and Nevada in 2027.
    • “The HMO will be available in 17 California counties and two Nevada counties on Jan. 1, a SCAN news release said. This is Costco’s first time offering MA.
    • “Entering Medicare Advantage is a natural extension of our commitment to delivering quality and value for our members,” Richard Stephens, Costco’s senior vice president of pharmacy, said.
    • “The plans do not include Costco memberships, but non-Costco plan members can use over-the-counter benefits and get hearing aids and eyewear elsewhere.”
  • “KFF Examines the 2027 Marketplace for Medicare Advantage and Part D Stand-Alone Drug Plans.”
    • “A companion analysis of the stand-alone Part D prescription drug plan (PDP) marketplace finds that the number of stand-alone plans available to the average beneficiary will fall for the fourth year in a row, from 11 in 2026 to 9 in 2027. It also finds that many PDP enrollees will see premium reductions or only modestly higher premiums in 2027 if they keep their current plan, while others will face substantially higher premiums unless they switch.
    • “Notably, there will be no zero premium PDPs available for Part D enrollees in 2027 (except low-income beneficiaries who receive extra financial help from the government.) That means that 4 million PDP enrollees who paid no monthly premium in 2026 will face higher premiums in 2027 if they keep PDP coverage.” 

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

  • Govexec reports today,
    • “Federal employees and retirees will pay an additional 10.9% on average toward their health insurance premiums in 2026, the third straight year of double-digit increases, according to the Office of Personnel Management.
    • “The government’s share of Federal Employee Health Benefits Program premiums will increase by an average of 8.6% in 2026, making the overall cost increase 9.3%. This year, the increase in employees’ share of insurance premiums was 12.3%, and in 2025 that increase apexed at 13.5%.”
    • “Unlike past years, OPM did not provide reporters with the average premium increases for the three plan types—self, self plus one and family—on a per paycheck basis. When asked for the information, the agency sent a copy of its “Open Season Highlights” document, and then a collection of spreadsheets listing every FEHB plan’s premium increase.” * * *
    • As in past years, OPM encouraged federal workers to shop around from among the more than 100 insurance plan offerings and to take advantage of using pre-tax money to pay for out-of-pocket costs via a flexible spending account. New for next year is the availability of a debit card via FSAFEDS, reducing some of the administrative burden of needing to submit paperwork and receipts for reimbursement.
    • Kevin Moss, a senior editor with Consumers’ Checkbook’s Guide to Health Plans for Federal Employees, said it is more important than ever to actually follow that advice. That’s because hidden behind the average premium increase figures are a number of wide swings on the individual plan level.

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

  • Fierce Pharma reports,
    • “The FDA has approved Bristol Myers Squibb’s application to expand the label of its cardiac myosin inhibitor, Camzyos, to include pediatric patients.  
    • “Camzyos is used to treat symptoms and improve functionality in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), a genetic condition that causes the heart muscle to thicken. Camzyos was first approved to treat adults in 2022, and the new approval makes it the first oHCM treatment available to pediatric patients.” 
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has accepted CeleCor Therapeutics‘ new drug application (NDA) for zalunfiban (Disaggpro). The investigational drug was developed to treat ST-elevation myocardial infarction (STEMI) heart attacks to dissolve clots and reopen the coronary artery as soon as possible to prevent death or irreversible heart damage.
    • “Zalunfiban is a new type of small-molecule inhibitor of the platelet GPIIb/IIIa receptor that is designed to quickly prevent clotting during a heart attack.
    • “The company presented positive Phase 3 clinical trials results from its CeleBrate study at the 2025 American Heart Association (AHA) Scientific Sessions, and those findings were later published in The New England Journal of Medicine Evidence.[1] The multinational CeleBrate study found that rapid zalunfiban treatment for STEMI at the first point of medical contact reduced the risk of cardiovascular events over 30 days following treatment.”

No Surprises Act news,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “On Thursday, October 1, 2026, the Centers for Medicare & Medicaid Services (CMS) convened leaders from across the federal government and from certified independent dispute resolution (IDR) entities to discuss issues impacting the federal IDR process. CMS Administrator Dr. Mehmet Oz, Department of Labor Assistant Secretary Daniel Aronowitz, and officials from the Departments of Health and Human Services, Labor, and the Treasury (the Departments) met with representatives from all certified IDR entities to address the increasingly high IDR-associated costs affecting the United States healthcare system. The ideas discussed in the meeting build on the system reforms that were a part of the Federal IDR Operations final rule as well as the fundamental technological evolution of the Federal IDR Portal into the IDR Gateway, which will launch in late 2026.” * * *
    • “The No Surprises Act has succeeded in its primary objective: protecting American consumers from surprise medical bills. The Departments and certified IDR entities expressed their shared responsibility to improve the federal IDR process. The participants, representing all active certified IDR entities, are committed to enhancing their processes in collaboration with the Departments. 
    • “The Departments will consider the insights offered by the certified IDR entities as they continue to explore all available regulatory and operational solutions.”

From the judicial front,

  • The SCOTUSblog reports today,
    • “On Thursday, the Supreme Court added three new cases to its oral argument docket for the 2026-27 term, including a case on the Trump administration’s policy of detaining noncitizens apprehended within the United States (as opposed to at the border) without the opportunity for a bond hearing and a dispute over the enforcement of zoning ordinances against religious institutions.” * * *
    • “Unlike past years, OPM did not provide reporters with the average premium increases for the three plan types—self, self plus one and family—on a per paycheck basis. When asked for the information, the agency sent a copy of its “Open Season Highlights” document, and then a collection of spreadsheets listing every FEHB plan’s premium increase.” * * *

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 low but is increasing.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.”
  • The University of Minnesota’s CIDRAP calls to our attention
    • “With three months left of 2026, the United States is closing in on a number of measles cases that would have been unheard of just a couple years ago. With 228 new cases logged this week, the country reached 3,886 infections, just 114 shy of 4,000, according to the Centers for Disease Control and Prevention’s (CDC’s) weekly update today.
    • “It could top that milestone next week. And US cases could be more than double the 2025 total this month.
    • “The national wave comes as Pennsylvania, the nation’s hot spot, adds more than 100 new cases in the past week to its total for the year. More than two-thirds of the cases in the state involve adults. * * *
    • “Cases in other states are also climbing. The Wisconsin Department of Health Services today added 72 infections to its total, which has now grown to 243. Kentucky added 27 new cases and has 94 for the year. And Ohio’s health department lists 206 measles cases, which is 17 more than last week. Utah lists 527 cases, nine of which are new.”
  • and
    • “Measles infections make people miserable for up to two long weeks, commonly causing dangerously high fevers, a painful sensitivity to light and, of course, a tell-tale red rash.
    • “Sufferers who escape without developing pneumonia, brain swelling, or other serious complications may believe the worst is over. 
    • “Yet the measles virus has only gotten started.
    • “The virus also damages the immune system, leaving people vulnerable to other infections for up to five years.
    • “The rash and the fever, that’s the tip of the iceberg,” Michael J. Mina, MD, PhD, coauthor of two seminal studies in Science on the effect of measles on the immune system, told CIDRAP News. “The majority of the damage being done is under the surface.”
  • The Wall Street Journal reports,
    • “Grip strength is increasingly being viewed as an important biomarker of our overall strength and fitness.
    • “While not used as widely as body-mass index, or BMI, as a screening tool for health, doctors and researchers say awareness of its value is growing. That’s happening as research shows that grip strength is associated with future health risks and even longevity. 
    • “At the University of Michigan Medical School, many clinics test patients’ grip strength, says Mark Peterson, a professor of physical medicine and rehabilitation. 
    • “We do it with our older populations but I have also gotten it pulled into clinics in our neurological population,” he says.
    • “Some doctors think grip strength should be used more routinely in wellness appointments. “I have really tried to encourage geriatricians to think about incorporating grip strength, it seems to trump almost every single measure including cardiovascular fitness training,” Peterson says.
    • “Even in children, studies have found grip strength to be associated with cardiometabolic health.” 
  • Nature relates,
    • “Armed with new tools and fresh optimism, researchers seeking to subdue pancreatic cancer — one of the world’s deadliest — are chasing a radical strategy: cancer interception.
    • “In this approach, tissues that are growing abnormally are treated to keep them from turning cancerous and spreading. Interception is already being trialled for breast and skin cancers, among others. But now the success of a new drug that quashes pancreatic tumours is raising scientists’ hopes that interception could succeed even for this recalcitrant cancer.
    • “Cancer interception was one of the main themes at September’s American Association for Cancer Research Conference (AACR) on Pancreatic Cancer in San Diego, California — the first such meeting since the US Food and Drug Administration approved the landmark pancreatic-cancer drug daraxonrasib (Rasonque) in August. Its success has renewed optimism that researchers can combine it or other emerging therapies with early-detection methods to revolutionize how pancreatic tumours are treated.
    • “A combination of early-detection techniques and interception is “going to be the breakthrough strategy that really changes survival”, says Diane Simeone, director of the Moores Cancer Center at University of California San Diego Health. At the AACR meeting, Simeone argued that such an approach could more than triple the proportion of people who survive for five years after being diagnosed with pancreatic cancer, from 13.7% to 50%.
    • “It’s a lofty aspiration, but other researchers are also eyeing interception. “We’re so excited that we are at this juncture now to even be considering this,” says Anirban Maitra, director of the Perlmutter Cancer Center at New York University Langone Health in New York City. “This wasn’t possible even a few years ago.”
  • CNN adds,
    • “Sugary foods combined with antibiotic treatment can damage the gut microbiome in ways that could leave people vulnerable to dangerous infections, a new study shows.
    • “The new research, published Wednesday in the journal Nature, took advantage of a natural experiment: It looked at what happened to gut bacteria in cancer patients who were hospitalized and treated with sustained antibiotics before receiving stem cell transplants. Because the patients only ate food prepared by the hospital, researchers knew exactly what and how much food they ate – a rarity in nutrition studies, which typically rely on participants to recall what they ate hours or days earlier, something people are notoriously bad at.
  • Health Day tells us,
    • “Functional decline begins many years before clinically apparent cardiovascular disease (CVD) events, according to a study published online Sept. 23 in JAMA Cardiology.
    • “Aung Zaw Zaw Phyo, Ph.D., from Monash University in Melbourne, Australia, and colleagues examined how functional performance trajectories change in the years preceding a CVD event. The analysis included data from 12,015 participants (2,403 cases and 9,612 matched controls) in the Aspirin in Reducing Events in the Elderly cohort.”
    • “Results of this nested case-control study show that declines in functional aging markers were prominent before clinically apparent CVD, suggesting that they may represent the culmination of progressive multisystem aging and indicating a prolonged window of opportunity for closer clinical evaluation and early intervention,” the authors write.”
  • and
    • “Isometric exercises like wall sits may help lower your blood pressure.
    • “And just one session a week could help you maintain those healthier numbers.
    • “A team led by Harry Swift of King’s College London studied 100 adults with an average age of 37 who had normal to high-normal blood pressure. Eighty were assigned to do wall sits three times a week.
    • “After four weeks, their systolic blood pressure — the top number in a blood pressure reading — had dropped by an average of about 9.5 points compared with the control group.
    • “For the next month, participants either kept the same schedule, cut back or stopped.
    • “Cutting back to once a week still left systolic pressure about 6.6 points lower than at the start.
    • “But three sessions a week delivered a much bigger benefit — down nearly 14 points.
    • “When participants stopped exercising, the improvements reversed.”
  • The American Medical Association lets us know how to do a wall sit.
  • Per BioPharma Dive,
    • “An experimental eczema drug from Pfizer met its primary goal in a mid-stage clinical trial, achieving stronger skin clearance in significantly more people at multiple doses compared to a placebo after 16 weeks.
    • “According to detailed data from an ongoing Phase 2 trial shared at a European medical meeting Thursday, a substantially higher percentage of patients given Pfizer’s three-pronged antibody drug, tilrekimig, as opposed to a placebo experienced a 75% reduction in the scope and severity of their disease. The trial enrolled participants with moderate to severe atopic dermatitis, and the latest results build on data previously announced in March.
    • “Analysts described the findings as “very strong” and indicative that Pfizer’s drug could compete with already approved therapies like Eli Lilly’s Ebglyss and Sanofi and Regeneron Pharmaceuticals’ market-leading Dupixent. In a statement Thursday, Pfizer said it has pushed tilrekimig into advanced testing for asthma, chronic obstructive pulmonary disease and atopic dermatitis — including a head-to-head trial against Dupixent.”

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

  • The Wall Street Journal reports,
    • “Bayer BAYN  said it plans to spend $2.2 billion to build a new manufacturing site in Ohio for its pharmaceutical business, becoming the latest European drugmaker to invest in the U.S.
    • “The German agricultural and pharmaceutical group said Friday that its new site in New Albany will create around 600 jobs, with plans to open a first module dedicated to drug substance manufacturing in 2031, followed by a second module for finished products in 2034.
    • “Bayer’s pharma business has been looking to expand in the U.S., betting that an enlarged presence in the world’s largest drug market can help it revive sales growth after two key products went off patent.
    • “With the move, the company joins a growing list of European pharma companies committing to invest in the U.S. Under pressure from the Trump administration’s tariff threats, big drugmakers like AstraZeneca, Novartisand Roche, as well as smaller rivals, pledged to make multibillion-dollar investments in the country and have started to execute their plans.
    • “The U.S. is our largest and fastest-growing market,” Bayer’s U.S. president, Sebastian Guth, said in an interview.”
  • and
    • “Novartis NOVN struck a deal valued at up to $7.8 billion to license a messenger RNA drug candidate from Abogen Biosciences and gain options over future therapies, turning to China to fill its pipeline.
    • “Many of the world’s biggest drugmakers have set their sights on China to look for new drug ideas, seeking to bolster their portfolios in preparation for older medicines going off patent. Novartis has sealed several tie-ups with emerging Chinese biotech players in recent years.
    • “Novartis is paying $575 million upfront and could make additional payments of up to $7.2 billion if options on all programs are exercised and targets are met, Abogen said Friday.
    • “Under the deal, Novartis will acquire worldwide rights over Abogen’s lead drug candidate, called ABO2203, which uses mRNA to boost the production of so-called T-cell engagers within the body to fight malignant cells. Abogen said its lead drug has potential to transform the treatment landscape for patients with autoimmune diseases—those in which the body’s immune system attacks healthy cells instead of protecting them.”
  • Modern Healthcare relates,
    • “HCA Healthcare has completed a deal to sell 31 home health and hospice locations in eight states to Deaconess Associations.
    • “The former HCA sites and their employees are now part of Deaconess subsidiary Central Pyramid, the Cincinnati-based provider announced in a news release Thursday. Neither Deaconess nor Nashville, Tennessee-based HCA disclosed the financial terms of the transaction.
    • “The home health and hospice locations are spread across Colorado, Florida, Kansas, Kentucky, Missouri, Tennessee, Texas and Virginia. The companies agreed to the transaction in June.”
  • Beckers Payer Issues tells us,
    • “San Francisco-based Dignity Health, part of Chicago-based CommonSpirit, reached an agreement to transfer its share of co-owned Arizona managed care health plan, Mercy Care, to CVS Health subsidiary Aetna.
    • “CommonSpirit had a 49.75% ownership interest in Mercy Care as of June 30, 2026, and June 30, 2025, according to CommonSpirit’s fiscal year 2026 report. 
    • “Dignity Health co-owns the plan with Ascension, which said it had also reached an agreement with Aetna to transfer its portion of Mercy Care to the company. 
    • “The transaction is expected to close in fiscal year 2027, subject to required regulatory reviews and approvals, a spokesperson for Aetna said in an Oct. 2 statement shared with Becker’s.” 
  • and
    • “New Jersey Democratic Gov. Mikie Sherrill launched the State Health Benefits Program Reform Working Group on Oct. 1 to review and advise on health coverage for public employees.
    • “Ms. Sherrill announced the working group following a Sept. 2 agreement with 17 state employee unions. Along with unions, participants include public employer organizations, legislative offices and healthcare groups, such as the New Jersey Association of Health Plans and New Jersey Hospital Association. Aetna, Horizon Blue Cross Blue Shield of New Jersey, and UnitedHealth Group’s pharmacy benefit manager, Optum Rx, are all vendors serving the benefits program. All three are also members of the working group.
    • “The working group will form advisory recommendations for the governor, focusing on benefits administration, provider network structures and payment, plan pricing and premium contributions, plan design, employer and member participation, and whether the program has resources to manage costs. The working group will have subcommittees targeting these areas.”
  • Fierce Healthcare adds,
    • “Tacoma, Wash.-based MultiCare Health System is set to launch its own health plan next year, the organization announced Thursday.
    • “The creation of the plan—dubbed the MultiCare Health Plan—is part of the organization’s continuing advancement from a traditional provider to an integrated organization, executives say. It will be a wholly owned subsidiary of the health system, with support from MultiCare’s population health partner, PSW.”
  • Beckers Hospital Review informs us,
    • “Chicago-based CommonSpirit Health has launched CommonSpirit Ambulatory Ventures, a new division aimed at organizing and expanding the health system’s ambulatory surgery center portfolio.
    • “The move is part of CommonSpirit’s broader effort to diversify beyond acute care and “accelerate growth” in ambulatory services, according to financial documents published Oct. 1. The system said the new division will establish an ASC vertical “from which to organize and enhance our current and future capability in the ASC space.” 
    • “CommonSpirit currently has 239 ambulatory joint ventures spanning dialysis, imaging, oncology and other services. That portfolio includes 80 ASCs, either wholly owned or operated through partnerships, along with six specialty surgical hospital partnerships.” 
  • Beckers Physician Leadership points out,
    • “After years of steady gains, compensation for registered nurses and licensed practical nurses (LPNs) showed no measurable growth in 2026 for the first time in the past 5 years, according to a report from Medscape. 
    • “The “Medscape RN/LPN Compensation Report 2026: Where Did the Growth Go?,” published Oct. 2, surveyed 3,253 registered nurses and 1,337 licensed practical nurses on compensation and pay trends.” 
  • Per Radiology Business,
    • “Patients grappling with medical debt appear more likely to face later-stage cancer diagnoses, according to new research published Thursday. 
    • “Such financial obligations are a pervasive challenge among U.S. households and a key social determinant of health, experts write in JAMA Network Open. About 1 in 6 individuals here report having at least some medical debt, with millions facing collections—a situation disproportionately impacting low-income households, minorities and the uninsured. 
    • “Researchers aimed to better understand how these IOUs impact patient outcomes, analyzing data spanning nearly 3,000 U.S. counties. They found that higher burden of medical debt was associated with significantly increased incidence of late-stage lung, colorectal, cervical, skin, kidney, bladder, and head/neck cancer. 
    • “These findings suggest that medical debt may be an area-level marker of structural and financial barriers associated with cancer detection and cancer outcomes at the population level,” study co-author Xin Hu, PhD, with the Department of Radiation Oncology at Emory University, Atlanta, and colleagues wrote Oct. 1.” 
  • Per Fierce Pharma,
    • “Eli Lilly’s Foundayo is showing clearer signs of acceleration. Total prescriptions for the oral GLP-1 receptor agonist surged about 21% to 64,268 during last week, according to IQVIA data cited by Citi. That haul came off a 13% sequential increase the week before that.
    • “We’re seeing early signs of growth in Q3 for Foundayo,” Jefferies analysts wrote in an Oct. 2 note.
    • “Recent expansion of Foundayo could be attributed to a direct-to-consumer ad first aired in late August featuring Martha Stewart, as well as the Medicare GLP-1 Bridge program which, as of July, offers eligible seniors GLP-1 obesity drugs at a $50 monthly copay.”
  • Cardiovascular Business adds,
    • “More and more young children are starting to be prescribed GLP-1 drugs to manage their weight, according to new research published in Pediatrics.
    • “The study’s authors focused exclusively on obese children without diabetes between the ages of 8 and 11. In 2019, just 0.03% of those children were on GLP-1 medications. However, that number skyrocketed to 9.3% in 2026. The group estimated that approximately 20,000 children between the ages of 8 and 11 have been prescribed GLP-1 drugs during that time. 
    • “Our study offers the first national overview in young children of the use of GLP-1 drugs to fight the obesity epidemic in the United States and shows that while the absolute numbers of children under the age of 12 receiving GLP-1 treatment is still low, GLP-1 use is accelerating rapidly,” first author Babak J. Orandi, MD, PhD, MSc, a transplant surgeon and obesity specialist with NYU Langone Health’s NYU Grossman School of Medicine, said in a statement. “The careful use of GLP-1s remains a valuable tool in confronting the obesity epidemic among young Americans.”
  • Beckers Payer Issues lets us know,
    • “Booking an appointment with a provider often means confirming they’re in network, working through an automated phone menu and trading available times with a receptionist. But for some UnitedHealthcare and Aetna members, an AI agent is now handling that work.
    • “Senior executives at both insurers have described their scheduling tools publicly in recent months as part of broader AI investments aimed at cutting administrative costs and simplifying how members get care.
    • “If I would usually schedule an appointment, I’d make a phone call, sit on hold, figure out my calendar, juggle my children. All that is gone, because Avery will do it for me,” Prianka Advani, senior vice president of AI delivery and telephony at UnitedHealth Group, said during a media event in June.”  

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • CBS News reports,
    • “The Senate confirmed Keith Sonderling to lead the Department of Labor on Wednesday, officially installing the nominee who has been leading in an acting capacity since Lori Chavez-DeRemer’s exit in April.
    • “In a party-line 47 to 41 vote, the Senate confirmed Sonderling.
    • “Sonderling served in several roles at the Department of Labor and the Equal Employment Opportunity Commission during President Trump’s first administration. He previously practiced employment and labor law at a Florida law firm.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services’ 340B Part D claims data repository became available Oct. 1 for voluntary data submissions. While data submissions will remain voluntary for now, the agency has proposed making data submissions mandatory starting Jan. 1, 2027. CMS has multiple resources available to support 340B entities and their third-party administrators with data submissions, including a user guide, companion guide, fact sheet and an FAQ.” 
  • and
    • “The Department of Health and Human Services’ Health Resources and Services Administration Oct. 1 announced approval of 10 drug companies to participate in the 340B Rebate Model Pilot Program. The approved companies are AbbVie, Amgen, Astellas Pharma US, AstraZeneca, Bristol Meyers Squibb, Boehringer Ingelheim Pharmaceuticals, GlaxoSmithKline, Merck Sharp & Dohme, Pfizer and Teva Pharmaceuticals. See the HRSA webpage for more details about the drug companies approved to participate in the Rebate Model Pilot Program, as well as FAQs.
    • “The AHA Aug. 7 issued a Regulatory Advisory that includes a detailed summary of the HRSA announcement on the rebate model pilot program. The program would begin Jan. 1, 2027.
    • “The AHA remains deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Pilot Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients,” an AHA spokesperson said. “We are reviewing today’s materials and are considering all available options to prevent this flawed program from going into effect.”
  • Beckers Hospital Review adds,
    • “An October report from Berkeley Research Group estimates how much patients and payers spend on 340B drugs, beyond what covered entities pay to acquire them.” * * *
      • “BRG calculates the gap between acquisition cost and reimbursement, which it calls “340B drug margin,” at $142.2 billion in 2025, more than double the $63.6 billion margin in 2021.
      • “Private and commercial insurers covered the largest share of that margin (63%), followed by Medicare (25%) and Medicaid managed care plans (7%). Medicaid fee-for-service generates no margin because it reimburses covered entities at acquisition cost.
      • “As a share of the overall U.S. pharmaceutical market, 340B prescriptions now account for 27% of net spending, up from about 18% in 2021. BRG attributed the program’s growth mainly to hospitals acquiring off-site clinics, expanded hospital participation following the Affordable Care Act and growing use of contract pharmacies, which now number roughly 35,000 nationally, up from about 1,300 in 2010.”
  • CMS has posted a table showing the “Top 10 Section 111 Group Health Plan (GHP) Reporting Error Codes from January 1- June 30, 2026”

From the Medicare Advantage front,

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

  • Govexec reports
    • “Nearly all of the portfolios in the federal government’s 401(k)-style retirement savings program lost value last month, as the broader investment market encountered broad volatility.
    • “The small- and mid-size businesses in the Thrift Savings Plan’s S Fund saw the worst decline, falling 3.86% in September. Since January, the S Fund is up 11.62%. The C Fund’s common stocks nearly broke even, finishing the month just 0.35% in the red. So far this year, the C Fund has grown 12.73%.” * * *
    • “The only TSP fund to post gains was the government securities of the G Fund, which grew at a statutorily mandated rate of 0.40%. So far this year, the G Fund has grown 3.41%.”
  • Tammy Flanagan, writing in Govexec, considers “Retiring in 2027? Picking the right date could pay off.”
    • “The date you leave federal service can affect when your annuity begins and how much you receive for unused annual leave.”

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

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved the Edwards Lifesciences Autus surgical pulmonary valvethat is the first size-adjustable valve designed for pediatric patients with congenital heart disease. The valve previously received FDA Breakthrough Device designation for its potential to address an important unmet need.
    • “Typically, children with congenital heart disease outgrow their valves and require repeat open-heart surgeries to explant the old valves and implant larger valves. Instead of repeat surgeries, the Autus is designed to be expanded as a child grows through a minimally invasive transcatheter procedure, offering a new, less invasive way to care for these children over the long term.
    • “This valve is a game changer,” explained Jennifer Romano, MD, MS, a heart surgeon at C.S. Mott Children’s Hospital, and past-president of the Society of Thoracic Surgeons (STS), in a statement from September when her team performed the first Autus procedure in the U.S. “Typically, we give these children a temporary fix, knowing they will need more surgeries down the road. “Now, we may be giving a child a valve that could potentially last them a lifetime. This could be transformative.”
  • MedTech Dive relates,
    • “The Food and Drug Administration has selected the first participants for an innovation challenge for home devices that could be used to reduce hospital readmissions.
    • “The first five participants include large medtech firm BD, wearable EEG startup Epitel, infant care company Prapela, Current Health, a company making software for cancer care, and Skribe Medical, which makes a device to assess cardiac function.
    • “The FDA’s device center plans to choose a total of nine participants by Dec. 4 for the challenge, called Reducing Readmissions through Device Innovation for the Home, or READI-Home. The selected manufacturers will have opportunities for early engagement with the FDA, including feedback on device design and testing, and demonstrations at the agency’s research facilities.”
  • and
    • “Medtronic said Wednesday it received a breakthrough device designation from the Food and Drug Administration for a drug-coated balloon catheter to treat peripheral artery disease below the knee.
    • “While drug-coated balloons are commonly used to treat PAD above the knee, none are indicated in the U.S. for use below the knee, where improved treatment options are needed, Medtronic said. PAD causes reduced blood flow to the limbs due to plaque buildup in the arteries. Patients with advanced PAD can be at risk for amputation.
    • “Medtronic said it is planning a randomized pivotal trial to study the paclitaxel-coated device, called IN.PACT BTK, in about 400 patients with below-the-knee lesions.”
  • BioPharma Dive identifies “5 FDA decisions to watch in the fourth quarter of 2026.”
    • “The next three months will feature anticipated decisions on a new kind of cancer immunotherapy, as well as medicines important to the futures of Roche, GSK and Gilead.”

No Surprises Act News,

  • Federal Hearings and Appeals Services, a certified independent dispute resolution entity, informs us,
    • “Our Account Services team members spend their days immersed in the Independent Dispute Resolution (IDR) process and fielding questions from parties. FHAS recently launched a new “Common Questions” series on our blog to share the questions we receive most often, and the answers we’re providing.
    • “Lately, we’ve seen some confusion around the new IDR Registry and the new IDR Gateway, so we’ll address those common questions, here. As a starting place, let’s clarify some basics.
    • “The Gateway is the platform. The Registry is a database inside it.
    • “The IDR Gateway is CMS’s new secure, account-based platform for managing Federal IDR disputes. It replaces the single-use web forms that parties have used since 2022.
    • “Both providers and payers need to register or sign up for a Gateway account. See our earlier post, The IDR Gateway Is Here, for more details on the Gateway roll-out.
    • “The IDR Registry is different. It is a searchable database of payer information that will live inside the Gateway.
    • “Only payers register in the IDR Registry – health insurance issuers, self-insured group health plans and their sponsors, and FEHB carriers. Each payer will carry an IDR registration number, and initiating parties will be able to access this number by referring to a given health plan’s notice of payment or denial.” * * *
    • “When might the Registry be available?
    • “Not right away, and the timeline has several steps. The Final Rule does not set a calendar date for the Registry. Instead, the Registry provisions become applicable 90 business days after the Departments issue guidance announcing that the Gateway functionality supporting the Registry is available, and payers have until the later of that date, or the date they begin offering coverage, to register. The Departments extended that window from the 30 business days originally proposed and noted that the extra time is meant to let payers set up lines of communication across their TPAs and service providers. CMS’s published implementation timeline lists the Registry first among the Gateway-dependent provisions it plans to roll out beginning in spring 2027, ahead of the new open negotiation, initiation, and IDRE selection workflows. Counting forward from a spring 2027 announcement, 90 business days runs roughly four to four and a half months. A reasonable expectation is that payers will be fully registered, and registration numbers will begin appearing on remittances, in the second half of 2027. The Departments have said they will publish updates as each provision is operationalized, and we will share those as they arrive.
    • “In the meantime, one related change lands sooner. Beginning with items and services furnished on or after Jan. 1, 2027, payers must use specified claim adjustment reason codes (CARCs) and remittance advice remark codes (RARCs) to indicate whether a claim is subject to the No Surprises Act and the Federal IDR process. That is a separate requirement from the Registry, but it addresses a neighboring question and arrives first.”
  • FEHBlog observation: I created a Gateway account for my client and upon doing so, all of the IDR cases showed up in a list. I compared the Gateway list against my list and I found two cases on my list that weren’t on the Government’s list. I am assuming that those cases were dropped without letting me know which is OK with me.

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Over 2 million new cancer cases were attributable to infections globally in 2024, according to an analysis of worldwide cancer incidence, highlighting the importance of effective prevention measures.
    • “Infections led to an estimated 2.3 million new cancer cases in 2024, including gastric cancer, cervical cancer, hepatocellular carcinoma, leukemias and lymphomas, and nasopharyngeal cancer, which accounted for 12% of all cancer cases worldwide.
    • “Among 12 carcinogenic infectious agents, the largest numbers of cancer cases were attributable to:
      • “Helicobacter pylori: 760,000 cases, population-attributable fraction (PAF) 4%
      • “Human papillomavirus (HPV): 750,000 cases, PAF 4%
      • “Hepatitis B virus (HBV): 360,000 cases, PAF 2%
      • “Epstein-Barr virus (EBV): 260,000 cases, PAF 1%
      • “Hepatitis C virus (HCV): 160,000 cases, PAF <1%
      • “Kaposi’s sarcoma-associated herpesvirus (KSHV): 35,000 cases, PAF <1%
    • Most cancers attributable to H. pylori were non-cardia gastric cancers (700,000 cases), while cervical cancer accounted for most HPV-attributable cases (600,000). HBV and HCV were responsible for 330,000 and 130,000 cases of hepatocellular carcinoma, respectively, while EBV led to 110,000 nasopharyngeal cancers, reported Harriet Rumgay, PhD, of the International Agency for Research on Cancer in Lyon, France, and colleagues in Lancet Oncology.”
  • and
    • “Maternal infection or sepsis is the third-leading cause of pregnancy-related death in the U.S., and Mississippi is the state with the third highest maternal mortality rate.
    • “In this study of Mississippi births, maternal sepsis disproportionately affected mothers with preterm births or c-sections, those with chronic comorbidities, Black women, and Medicaid enrollees.
    • “Overall, sepsis was recorded in 0.06% of the births from 2016 to 2025, but was involved in 32.4% of the delivery-associated hospital deaths.”
  • The American Medical Association lets us know “5 things patients should know about GLP-1 medications.”
    • “Sean Hashmi, MD, talks about the benefits of GLP-1 medications—as well as some misunderstandings—on the latest “Health vs. Hype” podcast episode.”
  • The latest issue of the National Institutes of Health’s Research Matters covers the following topics:
    • “Antiviral drug did not improve Long COVID symptoms” 
      • “A clinical trial for Long COVID found that treating patients with a common antiviral drug for up to 25 days did not improve symptoms.
      • “The findings suggest that other approaches to manage symptoms and treat Long COVID are needed.”
    • “tRNA treatment may help restore cystic fibrosis proteins” 
      • “Lipid nanoparticles that deliver engineered transfer RNA restored functional proteins in cell and animal models of cystic fibrosis.
      • “This strategy may represent a potential therapeutic approach for cystic fibrosis and other genetic diseases caused by nonsense mutations.”
    • “Bacterial infection may alter developing gut” 
      • “C. difficile bacteria caused lasting changes to cells in the intestines of newborn mice.
      • “The findings suggest that early-life C. difficile infections may alter gut stem cells and immunity into adulthood.”
  • Health Day relates,
    • “Stable employment in midlife is associated with better cognitive health in later life, according to a study published online Sept. 23 in Alzheimer’s & Dementia.
    • “Erika T. Beidelman, from the Columbia University Mailman School of Public Health in New York City, and colleagues used data from 2,418 participants in the Health and Retirement Study (1998 to 2014) to examine associations of workforce participation and job insecurity with later cognition.
    • “The researchers found that among women, compared with secure employment, self-employment, early retirement, not being in the labor force, and secure-to-retirement trajectories were significantly associated with lower memory and executive function scores (β range = −0.13 to −0.32 standard deviation units). For men, inconsistent employment was associated with poorer performance across most cognitive domains versus secure employment. In women, employment instability and early retirement were associated with higher odds of cognitive impairment.”
  • The New York Times offers “Clues to Why a Breakthrough Pancreatic Cancer Drug Eventually Stops Working”
    • “Researchers are asking why patients, like former Senator Ben Sasse, inevitably develop resistance to the drug daraxonrasib.”
  • Genetic Engineering and Biotechnology News tells us,
    • Methicillin-­resistant Staphylococcus aureus (MRSA) has rapidly risen to become one of the gravest threats to global health, with deaths from Staphylococcus aureus (S. aureus) having doubled worldwide since 1990. In severe cases, the bacteria invade the bloodstream in life-threatening systemic infections, which have a high risk of kidney injury and failure.
    • S. aureus is one of the most concerning bacterial pathogens, given that MRSA accounts for the largest increase in the global antimicrobial resistance burden. In addition, deaths attributable to S. aureus infections have doubled since 1990, making it a leading cause of bacterial mortality worldwide. Despite the continued focus on research, tissue reservoirs that permit bacterial persistence remain poorly defined.
    • “Now, a new study reveals how MRSA exploits the osmotic environment of the inner kidneys to establish a bacterial reservoir and hide from the immune system. This work suggests that MRSA can establish niches in the kidneys and the findings provide a mechanistic explanation for a longstanding question in the field of MRSA biology, and could inform future strategies aimed at limiting kidney damage from infections.
    • “This work is published in Science Translational Medicine in the paper, “Hyperosmotic niche adaptation and tissue polyamines underlie MRSA persistence in the kidney.”
  • STAT News informs us,
    • “Invivyd’s pursuit of a Covid vaccine alternative gets a lift, but an FDA hurdle may await
      • “The small biotech company is developing an injectable, low-dose monoclonal antibody.”
  • Per Fierce Healthcare,
    • “Taiho Pharmaceutical, together with U.S.-based subsidiary Taiho Oncology, has inched closer to approval of another oral combination treatment for patients with blood cancers.  
    • “In new phase 3 topline results, Taiho reported that its investigational, all-oral drug combination of azacitidine and cedazuridine successfully treated patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML), two blood disorders that can lead to acute myeloid leukemia (AML).
    • “Azacitidine is an established chemotherapy already used to treat MDS and AML. But Taiho’s formulation uniquely pairs the chemo with the cytidine deaminase inhibitor cedazuridine, which blocks the chemo-disintegrating enzyme cytidine deaminase in the digestive tract, allowing the cancer treatment to survive oral delivery.”
  • and
    • “While Foundayo’s insulin-matching potential in type 2 diabetes had been established in a topline readout earlier this year, Eli Lilly on Wednesday unveiled the fullest picture yet of its oral GLP-1’s ability to keep blood sugar in check, cut weight and, crucially, demonstrate cardiovascular safety in patients with compounding metabolic conditions.
    • “In a deep dive into the Indianapolis drugmaker’s late-stage Achieve-4 trial, which compared Foundayo (orforglipron) with titrated insulin glargine in adults with type 2 diabetes and obesity or overweight who were at increased cardiovascular risk, Lilly’s drug proved noninferior to insulin on the risk of major adverse cardiovascular events (MACE) while delivering greater reductions in A1C and weight.
    • “The comprehensive results were presented as part of Lilly’s showing at the European Association for the Study of Diabetes (EASD) annual meeting in Milan this week and simultaneously published in The Lancet.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of baxdrostat (Baxfendy™, AstraZeneca) and lorundrostat (Mineralys Therapeutics, Inc.) for hypertension.
    • “Downloads: Evidence Report | Voting Questions | Public Comments | Response to Public Comments
    • “High blood pressure is common, leads to serious complications like heart disease, strokes, and kidney failure, and is frequently undertreated,” said ICER’s Chief Medical Officer David Rind, MD, MSc. “Baxdrostat and lorundrostat are from a new class of medications intended for patients that may need more than standard first-line therapies. The hope is that they may have fewer side effects and reduce clinical events, but evidence for such benefits is currently limited.”
    • “Register here to watch the live webcast of the October 29th ICER public meeting.”

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

  • Beckers ASC Review reports,
    • “Philadelphia-based Penn Medicine, Independence Blue Cross and Franklin, Tenn.-based Regent Surgical are building an ASC company with a structure Regent CEO Travis Messina said the industry has not seen before: a health system, a health plan and a management company, all as owners.
    • “All the research that I’ve done suggests that there has never been a partnership in the ASC space that included a health system, a health plan and a management company,” Mr. Messina told Becker’s. “We believe it’s the first of its kind in that regard.”
    • “The three organizations announced Sept. 24 they will develop at least 18 ASCs across Pennsylvania, New Jersey and Delaware.” 
  • Beckers Hospital Review relates,
    • “Vizient named its 2026 top performers for quality, recognizing hospitals across seven cohorts and five medical groups for ambulatory care.
    • “The Bernard A. Birnbaum, MD, Quality Leadership Award is based on the Vizient Quality and Accountability Study. The study scores hospitals in six domains: safety, mortality, effectiveness, efficiency, patient centeredness and variation in care, according to a Sept. 24 news release from the company.
    • “The data comes from the Vizient Clinical Data Base, the Hospital Consumer Assessment of Healthcare Providers and Systems survey and the CDC’s National Healthcare Safety Network. The clinical database covers more than 1,600 hospitals across more than 250 health systems in 49 states.”
  • and
    • “Chicago-based CommonSpirit recorded an operating loss of $430 million (-1.0% operating margin) in fiscal 2026 — excluding special charges — compared to an operating loss of $687 million (-1.8% margin) the year prior, according to its Sept. 30 financial report.”
  • and
    • “Nashville, Tenn.-based Vanderbilt Health recorded operating income of $452 million (4.7% operating margin) in fiscal 2026, compared to operating income of $255 million (3.0% margin) the year prior, according to its Sept. 30 financial report.” 
  • and
    • “Morgantown, W.Va.-based WVU Health System has acquired Greensburg, Pa.-based Independence Health System’s five hospitals and their affiliated physician practices and outpatient facilities. 
    • “The hospitals are Butler (Pa.) Memorial Hospital, Clarion (Pa.) Hospital, Frick Hospital in Mount Pleasant, Latrobe (Pa.) Hospital and Westmoreland Hospital in Greensburg. They will begin operating under WVU Medicine’s brand immediately, according to an Oct. 1 news release.
    • “WVU Health System signed a definitive agreement June 2 to acquire the hospitals. The parties shared plans for the acquisition in mid-November 2025.”
  • and
    • “Tallahassee-based Florida State University and Tallahassee Memorial HealthCare have finalized core agreements that set the long-term framework for FSU Health, the university’s integrated academic health system for North Florida.
    • “The agreements include lease and operating agreements and other definitive legal documents, including an academic and clinical framework covering Tallahassee Memorial Hospital and a planned FSU Health hospital in Panama City Beach, Fla., according to a Sept. 30 news release.
    • “TMH will keep running day-to-day operations under the FSU Health brand. That includes Tallahassee Memorial Hospital, the future Panama City Beach hospital, TMH’s other clinical sites and its employed physician network, TMH Physician Partners. The deal keeps TMH’s existing charity care policy at both hospitals. It also creates a new governance structure that lets FSU nominate board candidates in Tallahassee and Panama City Beach.”
  • The Wall Street Journal lets us know,
    • “Walgreens’ private-equity owner is nearing a deal to sell U.K. pharmacy chain Boots for close to $9 billion including debt, according to people familiar with the matter.
    • “It has been discussing a deal to sell Boots to the Canadian arm of the Weston family, which owns a food-business empire, the people said. A deal could be completed in the coming weeks, assuming talks don’t fall apart.
    • “Sycamore Partners took Walgreens private in 2025 in a deal valued at $24 billion including debt (and roughly $10 billion without). It separated the company into five units to facilitate potential sales of noncore units, including Boots.
    • “Boots houses the former international businesses of Walgreens, which includes Boots operations in the U.K. and businesses in Thailand, Mexico, Germany and China.”
  • and
    • “France’s Sanofi SAN and Regeneron REGN Pharmaceuticals said they would expand their longstanding alliance to jointly develop and market new immunology medicines, in a deal that could net the U.S. drugmaker up to $8 billion.
    • “The two companies have collaborated for more than two decades in a partnership that spawned one of the top-selling medicines worldwide, Dupixent, approved for a range of conditions that include asthma and eczema.
    • “With Dupixent due to begin losing patent protection in the early 2030s, both sides had signaled they were discussing an updated framework for their relationship.” 
  • Fierce Healthcare tells us,
    • “Specialty pharmacy is a key cost driver for employers and insurers, with developments in this space showing no signs of slowing down.
    • “For example, a recent study from the Pharmaceutical Strategies Group found that 43% of employers and benefit leaders view managing specialty pharmacy spend as a top goal. And, per that report, while specialty drugs generally make up about half of the development pipeline, 76% of novel new drugs approved by the Food and Drug Administration in 2025 were specialty products.
    • “It’s with that backdrop that Blues-backed pharmacy benefit manager Prime Therapeutics convened stakeholders from across the pharmaceutical supply chain for its annual Specialty Summit last month. One of the prevailing themes of the conference—a need to break down silos between the pharmacy benefit and medical benefit to more effectively manage the full patient care journey.”
  • and
    • “Since 2022, federal price transparency rules have required health insurers to publish their negotiated hospital rates, aiming to give providers, employers and patients greater visibility into healthcare costs. However, the resulting machine-readable files are often so large and inconsistent that most organizations struggle to use them effectively.
    • A single payer’s pricing file can contain billions of rows, often published in varying formats and riddled with errors. According to a recent provider survey, nearly 40% of organizations report limited or no meaningful use of Transparency in Coverage data when preparing for payer negotiations. 
    • Startup Payerset launched four years ago to tackle this challenge, building the infrastructure required to normalize the data and render it usable across the formats healthcare organizations rely on. 
    • The company launched an artificial intelligence-powered, self-service research assistant that unifies negotiated rate data, claims, policy and market benchmarking into one platform. Payerset’s platform draws on 20 trillion rate records retained since 2024, with more than 10 trillion more processed every quarter, according to the company.
    • Using the research assistant tool, health systems can ask plain-English questions about their market position and get instant, data-backed answers, executives say.
    • “It’s like having extra researchers on your team,” Jerry DiMaso, Payerset co-founder and CEO, told Fierce Healthcare.
  • Healthcare Dive adds,
    • “Patients are less willing to use artificial intelligence for healthcare if it requires access to personal data or protected health information, according to a new survey.
    • “Healthcare consumers are primarily concerned about data privacy and the accuracy of AI-generated information, with around 89% saying AI responses in healthcare need human oversight, the survey by Wolters Kluwer shows.
    • “This trust gap means that less than a third of U.S. adults are using AI to find a healthcare provider, navigate their health insurance or create a diet plan, even though these applications are frequently marketed as key uses for AI in healthcare.”

OPM Releases 2027 Premiums

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

Simplicity is a virtue.

  • Per an OPM news release,
    • “Today, the U.S. Office of Personnel Management (OPM) announced that the 2026 Federal Benefits Open Season will run from November 9 through December 14, 2026. The rates and benefits for the 2027 Federal Employees Health Benefits (FEHB) Program, Postal Service Health Benefits (PSHB) Program, and Federal Employees Dental and Vision Insurance Program (FEDVIP) are now available for review on OPM.gov.
    • “During Open Season, eligible federal employees and annuitants can enroll in, change, or cancel FEHB, PSHB, and FEDVIP coverage. Eligible employees can also make elections for the Federal Flexible Spending Account Program (FSAFEDS).
    • “OPM encourages employees and annuitants to review their coverage and choose the options that best meet their needs and those of their families. FEHB, PSHB, and FEDVIP coverage will continue into 2027 if enrollees make no changes. FSAFEDS participants, however, must make a new election each year to continue that benefit. OPM also encourages eligible employees who do not currently participate in FSAFEDS to consider its pretax benefits and enroll.
    • “Open Season is the time to look beyond your current plan and make sure your coverage still works for you and your family,” OPM’s Associate Director for Healthcare and Insurance Matthew Kiley said. “We encourage employees and annuitants to compare their options, review their costs, and make any changes before the December 14 deadline.”
  • FedWeek adds
    • “Federal employees and retirees enrolled in FEHB will pay an average annual increase of 10.9 percent more for their share of premiums in 2027 (down from 12.3 percent for the current year), according to an OPM announcement. PSHB enrollees will see an average increase in their share by 8.2% (11.3 percent in 2026).
    • “Dental and vision premiums are rising just 1 percent and 1.6 percent on average.
    • “According to the announcement, increases are due largely to “rising prices and utilization across inpatient, physician, outpatient, and surgical services; Continued growth in behavioral and mental health care; and; Higher prescription drug spending—particularly on GLP-1s, specialty drugs, and other high-cost therapies.”
  • Federal News Network also has an article on the OPM announcement.

More News from Washington, DC,

  • The Hill reports,
    • “A group of lawmakers spanning both parties and chambers is introducing legislation that would require insurance plans to cover genetic testing for patients with hereditary risk factors and expand education and outreach about gynecologic cancer risk. 
    • “Sens. Elissa Slotkin (D-Mich.) and Katie Britt (R-Ala.) are leading the bill, the Ovarian Cancer IMPACT Act, which was shared exclusively with The Hill. Their House counterparts on the legislation are Reps. Rosa DeLauro (D-Conn.) and Don Bacon (R-Neb.).” * * *
    • “In addition to some provisions about insurance coverage of genetic screenings, the new bill includes reauthorization of a 20-year-old Centers for Disease Control and Prevention program, Johanna’s Law, that provides funding for a federal education campaign about gynecological cancers.” 
  • The Washington Post adds,
    • “President Donald Trump’s pick for surgeon general cleared a major hurdle Wednesday as the Senate health committee voted to advance her nomination to the floor.
    • “In a 12-11 party line vote, Nicole Saphier — a former Fox News contributor and radiologist at Memorial Sloan Kettering Cancer Center in New York — took a step closer to becoming the nation’s top doctor.” * * *
    • The [12-11] vote included advancing the nomination of Timothy Westlake, Trump’s pick to head the Substance Abuse and Mental Health Services Administration, which leads policy efforts on mental health and addiction. He is a board-certified emergency physician. It also included one more health nominee, Mary Lazare, to be assistant secretary for aging.
  • Bloomberg Law relates,
    • “The Trump administration finalized on Wednesday a new drug payment modeldesigned to help carry out its most-favored-nation policy, cementing a plan that pharmaceutical companies have signaled are ripe for legal challenges.
    • “The pricing demo, known as GLOBE, would test whether alternative methods for calculating rebates for Medicare Part B medicines administered in doctors’ offices, based on international pricing metrics, will reduce drug costs.
    • “Still, over two dozen drugmakers — including Eli Lilly & Co., Novo Nordisk A/S, and Pfizer Inc.— have indicated they’ve gotten exemptions after entering separate agreements with the administration to voluntarily offer discounts on certain medicines to state Medicaid programs known as GENEROUS. The rule text appears to confirm that carve-out.” * * *
    • “The model is set to start Jan. 1, 2027 with the collection of voluntary manufacturer-submitted international drug net pricing data. It will be tested over five performance years, running through March 31, 2032. 
    • “A separate model targeting Medicare Part D drugs, which are prescription medications dispensed at pharmacies, is still under review at the White House.” 
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H), today launched a major effort to transform how clinical trials are designed and conducted — using advanced computational models, real-time analysis, shared infrastructure, and automation to evaluate drugs and biologics faster, at lower cost, and with fewer participants. The new Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, together with three complementary projects announced today, aims to remove barriers that slow clinical development and help promising treatments reach patients sooner.
    • “America should lead the world in turning medical breakthroughs into treatments for patients,” said HHS Secretary Robert F. Kennedy, Jr. “HHS is taking on the delays, duplication, and unnecessary costs that slow clinical trials down. Through ARPA-H, we are building a modern clinical trial system that can generate rigorous evidence faster, reduce the burden on patients, and move effective treatments from discovery to the people who need them sooner.”
    • “Together, these efforts advance the Trump administration’s work to modernize clinical development, reduce unnecessary delays and costs, and strengthen U.S. competitiveness in biotechnology and drug development. By making clinical trials faster, more efficient, and less burdensome for patients, ARPA-H aims to help promising treatments reach patients sooner while reinforcing the United States as a global leader in medical innovation.”
  • The American Hospital Association News tells us,
    • “Two executive orders on artificial intelligence were released Sept. 29 by the White House. One announced a new website that will use AI to deliver federal government information and services. The website, America.gov, is intended to eliminate the need for navigating multiple agency websites, according to a fact sheet. The order directs the Administrator of General Services in coordination with the Director of the Office of Management and Budget to establish and operate America.gov as the lone entry point for accessing covered services online, such as public-facing federal services that serve more than 100,000 users in a 12-month period and can be accessed or applied for online.
    • “The second executive order announced a rebrand of AI as “super intelligence.” The order and correspondingfact sheet said that the administration will use “super intelligence” and “SI” in place of “artificial intelligence” and “AI” in official correspondence, public communications, websites, reports, policy documents and other non-statutory documents.” 
  • Beckers Hospital Review informs us,
    • “The Pharmaceutical Research and Manufacturers of America has named Eric Cantor its next president and CEO, effective Nov. 9.
    • “Mr. Cantor will succeed Stephen Ubl, who has led PhRMA since 2015, according to a Sept. 29 news release. Mr. Ubl will continue to serve as a strategic adviser.
    • “Mr. Cantor represented Virginia in the U.S. House of Representatives from 2001 to 2014 and served as House majority leader from 2011 to 2014. Since leaving Congress, Mr. Cantor has served as vice chairman and managing director at Moelis & Company and as a member of its board of directors. He will continue serving on the board while leading PhRMA.”

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

  • BioPharma Dive reports,
    • “The Food and Drug Administration has accepted an approval application for Roche’s experimental multiple sclerosis pill fenebrutinib, kickstarting a review of the treatment in two forms of the disease.
    • “The agency will begin evaluating fenebrutinib in both the “relapsed” and “primary progressive” types of MS, positioning the treatment to possibly become the first of its kind approved in both settings. Roche didn’t say when a decision might come, though the agency has initiated a “priority review” that has a six-month timeline.
    • “Roche’s application is based on a trio of late-stage studies that met their main objectives. However, an imbalance in the number of deaths observed among treatment recipients and regulators’ pre-existing concerns about the liver safety of drugs like fenebrutinib could complicate the company’s approval chances.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health. As part of an effort to broaden and strengthen participation on its advisory committees, the FDA is publishing two Federal Register notices: one seeking qualified scientific, technical, and professional voting members across all committees with current or anticipated vacancies, and a companion notice seeking consumer representatives to ensure the public’s voice is at the table.  
    • “FDA advisory committees bring together leading scientific minds to engage with the most difficult questions in public health. We are actively inviting people from across the country who are on the forefront of their fields — clinicians, researchers, and community voices who can bring the latest science, real-world experience, and fresh perspectives to the FDA’s deliberations,” said Acting FDA Commissioner of Food and Drugs, Kyle Diamantas, J.D. “These panels provide independent expertise and rigorous scrutiny as the FDA navigates complex and rapidly evolving areas of science. The Trump Administration is deeply committed to strengthening the partnership between the FDA and the nation’s brightest minds.”  

From the Medicare Advantage front,

  • Beckers Payer Issues reports,
    • “There will be four new entrants to the Medicare Advantage market in 2027, according to CMS data.” * * *
      • The Muscogee (Creek) Nation will offer one HMO, called Native Advantage, in 11 Oklahoma counties.
      • Boise, Idaho-based St. Luke’s Health System will offer three HMOs with drug coverage through its health plan in seven counties across Idaho. St. Luke’s launched its health plan with individual and employer coverage in 2023.
      • Tacoma, Wash.-based MultiCare Health System will offer two HMOs with drug coverage in three Washington counties through its newly launched health plan. 
      • MedCare Partners Health Plan of Texas will offer three plans in Harris County, including one HMO and two C-SNPs.
  • Beckers Hospital Review adds,
    • Seven health system-affiliated insurers are among the 11 total health plans exiting the individual Medicare Advantage market for 2027, according to CMS data.
      • Irving, Texas-based Christus Health Plan offered plans in 36 Texas counties and eight New Mexico counties.
      • Wausau, Wis.-based Aspirus Health Plan offered plans in 21 Wisconsin counties.  In February, CMS suspended new MA enrollment into the health plan after its claims processor, UCare, was taken over by Minnesota regulators.
      • Renton, Wash.-based Providence Health Plan offered plans across six Oregon counties, six Washington counties and Orange County, Calif. The MA exit is part of the wider shutdown of the health plan.
      • WellSense Health Plan, part of Boston Medical Center, offered plans in all 10 New Hampshire counties.
      • Houston-based Memorial Hermann Health Plan offered plans in six Texas counties. In July, the plan confirmed it would also shut down its commercial business.
      • Mass Advantage, part of Worcester-based UMass Memorial Health, offered plans in Worcester County.
      • San Diego-based Sharp Health Plan offered plans in San Diego County.

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Pennsylvania reported Wednesday that a fifth person who had measles has died as rising infections in the state continue to push up the country’s record-breaking count of cases.
    • “The Pennsylvania Department of Health said an unvaccinated Lancaster County resident who tested positive for measles had died. No additional information about the person was immediately released.”
  • Health Day relates,
    • “Type 2 diabetes dramatically increases a person’s short-term risk of death or life-threatening illness, a new study says.
    • Within five years of their diagnosis, patients with type 2 diabetes have a 33% increased risk of dying or developing kidney disease or heart failure, researchers are slated to report this week at a meeting of the European Association for the Study of Diabetes.
    • “That risk increases to 55% over 10 years, researchers added.
    • “Our findings clearly show how the serious complications associated with type 2 diabetes rise sharply over time as the often-common combination in patients of obesity, abnormal blood fats, high blood pressure and higher blood sugar damages blood vessels and vital organs,” lead researcher Naveed Sattar said in a news release. He is a professor of cardiometabolic medicine at the University of Glasgow in Scotland.”
  • Cardiovascular Business tells us,
    • “The American College of Cardiology (ACC) has published a new scientific statement focused on how eating well can help with the prevention and management of cardiovascular disease (CVD). The document, published in full in JACC, is the work of a committee of experts from the fields of cardiology and nutrition that first met in April.[1]
    • “Suboptimal diet is a key risk factor for CVD, and diet and lifestyle modification is widely considered essential for both primary and secondary prevention,” Frank B. Hu, MD, PhD, chair of the department of nutrition at Harvard T.H. Chan School of Public Health and chair of this document, said in a statement. “However, the concept of a ‘heart-healthy’ diet has evolved over time from nutrient-centric approaches to more holistic, food- and pattern-based strategies that better reflect advances in the understanding of the complex relationship between diet and cardiometabolic health.”
    • “The ACC scientific statement highlights the importance of following a heart-healthy diet, pointing to the Mediterranean diet and dietary approaches to stop hypertension (DASH) diet as two specific examples. Plant-based foods and healthy fats and proteins are recommended over foods high in refined starches, added sugars and unhealthy fats. The document also gets more specifics, emphasizing the benefits of vegetables, fruits, whole grains, nuts and legumes, while warning against the risks associated with eating too many ultra-processed foods.”
  • Health Day informs us,
    • “Insomnia is associated with an increased risk for stroke and with higher odds of hospital admission, according to an umbrella review funded by the European Academy of Neurology and published online Sept. 7 in Sleep Medicine Review.
    • “Luca Vignatelli, M.D., from the IRCCS Istituto delle Scienze Neurologiche di Bologna in Italy, and colleagues identified systematic reviews with meta-analyses (SRMAs) that examined insomnia as a predictive factor for dementia, stroke, depression, suicide, death, occupational injuries, and hospitalization. Sixteen SRMAs were included, and three additional original reviews were conducted for stroke, occupational injuries, and hospitalization.
    • “The researchers found that insomnia was consistently identified as a predictor of dementia, depression, and suicide, but not death, in SRMAs. Insomnia was a predictor of stroke (hazard ratio, 1.26) and of hospitalization for any reason (odds ratio, 1.28) based on two original SRMAs. A meta-analysis could not be performed on the two studies relating to occupational injuries. There was an association with unintentional fatal injuries and commuting injuries, but data were insufficient to draw a conclusion.”
  • and
    • “Chronic stress may hit women’s brain power harder than men’s as they age.
    • “A new study of nearly 3,900 healthy adults age 50 and older without dementia found women with higher levels of ongoing stress had steeper declines in attention and language than men.
    • “Researchers said it’s not yet clear why — or whether the difference is tied to biology, such as hormones, or social factors like gender roles.
    • “Hispanic participants with higher stress also had greater memory decline than non-Hispanic white participants.
    • “But there was an encouraging finding across all groups: Greater social support was linked to less decline in attention.”
  • Beckers Behavioral Health points out,
    • “The prevalence of benzodiazepine dispensing in the U.S. fell 26.7% from 2013 to 2024, with the largest relative decline among adults ages 18-29, according to a study published Sept. 30 in the American Journal of Psychiatry.
    • “Researchers from Rutgers University in New Brunswick, N.J., and Columbia University in New York City analyzed 1.1 billion benzodiazepine prescription fills among 252 million patients age 2 and older using the IQVIA Longitudinal Prescription dataset. The study examined changes in prescription prevalence, prescription counts and mean total dose dispensed by patient age and prescriber type.
    • “The declines may reflect greater caution in benzodiazepine prescribing, potentially tied to growing awareness of the drugs’ role in opioid-related overdoses and to FDA boxed warnings issued in 2016 and 2020, according to the researchers. The 2016 warning cautioned against prescribing benzodiazepines alongside opioids, and the 2020 warning addressed risks of misuse and addiction.” 
  • Health Day adds,
    • “A quick spritz to the nose could bring rapid pain relief to injured kids cared for in emergency rooms, new research shows.
    • “According to experts, too many pediatric ER patients are waiting too long for pain relief.
    • “Nearly a third of children with moderate to severe pain do not receive adequate pain relief within the 15 to 20 minutes recommended in international guidance,” noted study lead author Dr. Shammi Ramlakhan of Sheffield Children’s Hospital in England. 
    • “The new nasal spray combines two medications, sufentanil and ketamine. This combo eased pain within a half-hour for most injured kids in the study, Ramlakhan’s team said. 
    • “The results suggest it helps to reduce pain quickly and effectively, without the need for an injection,” said Dr. Maša Sorić, head of the emergency department at University Hospital Merkur, Zagreb, Croatia.
    • “Sorić, who wasn’t involved in the study, noted that “the treatment did not cause too much drowsiness, and the side effects were mild.”
  • BioPharma Dive notes,
    • “Bristol Myers Squibb has changed a late-stage study of its experimental pulmonary fibrosis drug admilparant to more closely monitor for liver-related side effects, following a “limited number” of instances of liver damage as well as the death of a participant from liver injury, a spokesperson said Wednesday.
    • “The change to the long-term safety extension to its Phase 3 “Aloft” trial raised investor worries about admilparant’s drug class, called LPA1R inhibitors, which are viewed as a new way to slow progression of the lung disease idiopathic pulmonary fibrosis. Shares in Bristol Myers as well as Contineum Therapeutics, the developer of a similar drug, fell sharply in late-day trading Tuesday before rebounding early Wednesday. 
    • ‘A spokesperson confirmed that it’s unclear whether the patient who died received admilparant. Wall Street analysts also called the brief share pullback “overdone,” pointing to multiple factors that could’ve contributed to the death and the relatively mild nature of the other side effects observed. Bristol Myers expects to report study results by the end of the year, an announcement that could shed more light on the safety of admilparant and other drugs in its class.”
  • STAT News lets us know,
    • “An investigational combination therapy from Eli Lilly led to significant weight loss in a mid-stage study, but high rates of people stopping the treatment may raise questions about its tolerability. 
    • “Lilly, which is racing to bring next-generation obesity drugs to the market, tested different combinations of its blockbuster GLP-1 drug Zepbound with eloralintide, a candidate that targets the amylin hormone, in people with obesity and type 2 diabetes.
    • “After 48 weeks, participants who stayed on the treatment at the highest dose of the combination therapy lost 23.3% of their weight, according to results presented Wednesday at the annual meeting of the European Association for the Study of Diabetes. That’s more than the weight loss seen with those taking only Zepbound and those taking only the highest dose of eloralintide — 14.8% and 11.1%, respectively.
    • “The results were also notable because patients with diabetes don’t tend to lose as much weight on medications as those who don’t have diabetes.
    • “However, there were high rates of participants stopping the combination therapy due to adverse events — ranging from 10.8% to 27.0% among the different dose groups. Those taking only eloralintide had discontinuation rates ranging up to 10.8% across dose groups, and those taking only Zepbound had a rate of 2.9%.
    • “The new combination therapy, called EloraTZP, is a potential competitor to Novo Nordisk’s CagriSema, an investigational combination of an amylin drug called cagrilintide and its own Wegovy that’s further along in development. Given the high discontinuation rates in the new trial, it’s difficult so far to compare EloraTZP with CagriSema.”

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

  • Modern Healthcare reports,
    • “Cigna Group is forecasting future growth and billions in cost savings, the company disclosed Wednesday.
    • “The healthcare behemoth reaffirmed its guidance for this year and projected at least $45 in adjusted earnings per shareby 2030 during the company’s investor day.
    • “Cigna Group will also save $3 billion over multiple years, partly from automating workflows and implementing artificial intelligence, said Ann Dennison, executive vice president and chief financial officer. Some of those savings will be invested back into the company, she said.”
    • “Cigna Healthcare is launching Health Sense early next year as part of its new partnership with OpenAI. Health Sense is a personalized clinical support model, which the company claims will reduce inefficient care by 10% by 2030.
    • “The company is also building a fifth “clean room,” a sterile facility where complex drugs are compounded and mixed. It will take up to three years to fully build and license, according to executives.
    • “This will create capacity for millions of new prescriptions to keep up with rising demand,” said Matt Perlberg, president of pharmacy and care delivery at Evernorth Health Services and executive vice president of customer innovation at Cigna Group. 
    • “Evernorth is also launching a wholesale distribution channel alongside its specialty distributor division CuraScript, which serves more than 12,000 healthcare providers, to gain access to new medications.”
  • Beckers Payer Issues relates,
    • “Tom Curtin was named executive vice president of Kaiser Permanente’s National Health Plan after serving as its interim leader since May.
    • “In the role, effective immediately, Mr. Curtin will lead health plan strategy and operations with a focus on growth, affordability and expanding access to the Oakland, Calif.-based system’s value-based care model, according to a Sept. 29 news release. He reports to Chair and CEO Greg Adams.
    • “During his time as interim leader, Kaiser Permanente added more than 223,000 members in 2026, positioning the organization for its strongest membership growth since 2018, the release said.”
  • Fierce Healthcare tells us,
    • “Performance-based contracting is becoming the norm for digital health solutions, with the majority of employers and health plans tying vendor payments to clinical and financial outcomes, according to a new survey from Peterson Health Technology Institute (PHTI).
    • “Specifically, 68% of employers and 55% of health plans are using such contracts. Eighty-five percent of contracts tie at least a quarter of fees to performance while 31% tie more than half, PHTI analysts wrote in the report (PDF).
    • “The report drew insights from 321 digital health professionals responsible for purchasing across health plans, employers and health systems. Four main areas were covered: purchasing approach, artificial intelligence adoption, contracting process and future plans.”
  • and
    • “Satisfaction with pharmacy benefit managers has stabilized in 2026, though the likelihood of contract renewal without a competitive request for proposal declined, a new report from Pharmaceutical Strategies Group (PSG) found. 
    • “The report drew insights from 250 benefits leaders representing employers, health plans, healthcare organizations and union plans. Respondents were asked to rate satisfaction with PBMs on a 10-point scale, with overall satisfaction receiving a 7.2 score, up from 7.1 in 2025. 
    • “On a similar scale, the likelihood to renew contracts without issuing competitive RFP fell to 6.4—which analysts note is the “lowest point in recent history.”
  • MedTech Dive informs us,
    • “Abbott said Wednesday it is launching Freenome’s SimpleScreen CRCblood-based test for colorectal cancer in the U.S. as an option for people who decline to complete medical guideline-recommended screening.
    • “SimpleScreen CRC is an addition to the Cologuard Plus stool-based test in Abbott’s colorectal cancer screening portfolio. Abbott acquired Cologuard in March in the $21 billion buyout of Exact Sciences.
    • “Freenome developed the SimpleScreen test and manufactures it. Abbott will distribute SimpleScreen in the U.S. under a commercial agreement with Freenome. The test, which won Food and Drug Administration approval this summer, will compete in the market with Guardant Health’s Shield blood test for colorectal cancer screening.”
  • Fierce Healthcare points out,
    • “Trinity Health System, a four-hospital system in eastern Ohio, will officially be handed over from CommonSpirit Health to University of Pittsburgh Medical Center (UPMC) on Oct. 1, the large nonprofit organizations shared Wednesday. 
    • “The deal is a geographic expansion for UPMC, which to date has limited its acute footprint to Pennsylvania. Financial terms of the deal still have not been disclosed. 
    • “By integrating Trinity Health System into UPMC, we are building upon a foundation of trusted collaboration to ensure that high-quality, patient-centered care remains accessible and sustainable for years to come,” Dwayne Richardson, interim market president, of Trinity Health System, said in the announcement. “We know that UPMC shares our dedication to clinical excellence.”
    • “Alongside the hospitals—Trinity West and Trinity East in Steubenville, Trinity Twin City Medical Center in Dennison and Trinity St. Clairsville Neighborhood Hospital in St. Clairsville—UPMC is acquiring associated clinics and sites delivering urgent care and behavioral health care.” 
  • Per Beckers Hospital Review,
    • “Dallas-based Baylor Scott & White Health reported operating income of $1.5 billion (8.3% margin) during the fiscal year ending June 30, 2026, down from a $1.7 billion operating gain (10% margin) in the previous fiscal year, according to financial statements published Sept. 30.”
  •  and
    • The number of first-year students at U.S. medical schools that grant MD degrees rose 36.8% from the 2005-06 academic year to 2025-26, but fewer are staying in their home state. 
    • Over the same period, the share of those students who come from the school’s home state declined, according to a study published Sept. 29 in JAMA.
    • The study’s authors, Barbara Barzansky, PhD, and Felicia Walker, work for the American Medical Association, which funded the research. They used data from the Liaison Committee on Medical Education’s 2025-26 Annual Medical School Questionnaire. Of the 160 medical schools the committee accredits, 158 responded.
  • Per MedCity News,
    • “AstraZeneca is making a $2 billion equity investment in Summit Therapeutics, a business deal that also kicks off a research collaboration that could pursue multiple drug combinations with an initial focus on gastrointestinal cancers.
    • “The deal announced after Monday’s market close is a vote of confidence in the Summit cancer drug ivonescimab, a bispecific antibody designed to bind to two targets, PD-1 on T cells and VEGF on cancer cells. Several oncology-focused pharmaceutical companies have already struck deals to add such drugs to their pipelines. Summit’s late-clinical drug gives AstraZeneca access to a contender in the class.
    • “Ivonescimab was developed by China-based Akeso Therapeutics. Phase 3 trial results in lung cancer raised hopes for the molecule as data showed it beat Merck’s blockbuster PD-1 inhibitor Keytruda in a head-to-head study. But those results were from a trial in China, where the drug has approvals in lung cancers and is marketed by Akeso. For Summit, ivonescimab’s prospects ride on the results of clinical trials the company is conducting in outside of China. Summit holds rights to the drug in North and South America, Europe, the Middle East, Africa, and Japan.”
  • Per Radiology Business,
    • “Solis Mammography has inked a new imaging joint venture with HCA Healthcare, the two announced on Monday. 
    • “The Addison, Texas-headquartered breast imaging provider is teaming with America’s largest health system to expand services in South Carolina. It will work with HCA Healthcare’s Trident Hospital, with its breast imaging services now branded under the Solis Mammography name. 
    • “This marks the private equity-backed imaging group’s first foray into South Carolina. Solis said the two have plans to further expand into additional HCA facilities across the greater Charleston area, boosting local access to breast imaging services. 
    • “Partnering with Solis Mammography reflects our deep commitment to the women and families who call the Lowcountry home,” Hugh Tappan, MBA, president of HCA Healthcare’s South Atlantic Division, said in a statement Sept. 28. “We want every woman to feel supported and confident in her breast health journey, with access to exceptional care close to home.”
  • Per Cardiology Business,
    • “Artificial intelligence (AI) is increasingly being incorporated into cardiovascular imaging, but at Mass General Brigham, some of the most practical applications are focused on streamlining the imaging workflow rather than replacing or double-checking what radiologists and cardiac imagers already do.
    • “Brian Ghoshhajra, MD, MBA, medical director of radiology and clinical operations for integrated imaging services at Mass General Brigham and an associate professor of radiology at Harvard Medical School, discussed the health system’s approach to AI and automation with Cardiovascular Business.
    • “Ghoshhajra said imaging can be viewed as a chain that begins with ordering and scheduling, moves through protocoling and quality assurance and ends with interpretation and reporting. While much of the attention surrounding AI has focused on interpretation, he said there may be significant opportunities to improve the earlier steps of the process.
    • “At Mass General Brigham, for example, automation has been used to reduce the amount of manual work required for protocoling cardiovascular CT examinations. Ghoshhajra said the system has grown from performing about five cardiac CT examinations per day when he was a fellow 18 years ago to approximately 85 to 100 studies per day across multiple hospitals using a hub-and-spoke model.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Beckers Payer Issues reports,
    • “CMS released initial insights on the 2027 Medicare Advantage landscape Sept. 28, along with data breaking down plans.
    • “One wrinkle gaining attention: enrollment capacity limits. In April, CMS said insurers could include enrollment caps for specific plans in their 2027 MA bids, relying on existing regulatory authority. With these caps, plans cannot disenroll current members. Once a plan hits its cap, it must stay closed to new enrollees until space opens up through natural attrition, according to the April memo. The agency baked enrollment caps into its August guidance for MA payers. 
    • ‘Ceci Connolly, president and CEO of the Alliance of Community Health Plans, recently told Becker’sthat her organization made progress with CMS on “tweaks with respect to the regulatory perspective,” including enrollment caps.” * * *
    • Becker’s reviewed the 65 MA plans — including MA plans with prescription drug coverage and special needs plans — with enrollment caps. [As disclosed in the article, t]hese plans are available in 11 states and span 15 parent organizations. The caps range from 410 to 56,345 members.
  • The New York Times relates,
    • “The Department of Veterans Affairs announced new measures on Monday that will require written informed consent by patients before they are prescribed certain psychiatric drugs.
    • “The shift reflects a growing disenchantment with psychotropic medications that has animated the Make America Healthy Again movement and its chief standard-bearer, Health Secretary Robert F. Kennedy Jr.
    • “The new policy will require veterans under age 30 to sign consent forms before receiving antidepressants, and it mandates documented discussions about the risks and benefits of the treatments, including how to safely discontinue them.
    • “The guidance also requires a signed consent form when patients are concurrently prescribed opioids and benzodiazepines. The measure will go into effect in 2027.”
  • STAT News adds,
    • “A growing number of congressional lawmakers are urging the Trump administration to rethink a federal rule going into effect next month over concerns it will prevent Americans from obtaining prescription medicines from licensed international pharmacies.
    • “The pending rule requires medicines mailed from abroad to go through a customs process that mandates a licensed customs broker and a financial guarantee in the form of an entry bond. This is an added burden — and cost — for Americans who, for years, have been able to receive prescriptions from Canada and other countries with relatively little difficulty as they sought to save money on expensive drugs.”
  • and
    • “In the last month, manufacturers have announced “breakthrough” status from the Food and Drug Administration for a menagerie of devices: triage algorithms for abdominal CT scans, diagnostic panels for urinary tract infections, and thrombectomy robots, to name a few.
    • “They’re coming in just under the wire: As of October, new breakthrough-designated devices will no longer be eligible for special treatment when it comes to qualifying for extra Medicare payments. These devices, and more than a dozen others, are included in the latest update of STAT’s Breakthrough Device Tracker, which since 2022 has captured nearly 800 devices reported to have FDA breakthrough status.” 
  • Beckers Hospital Review notes,
    • “Section 232 tariffs on patented pharmaceutical products and associated pharmaceutical ingredients take effect today, Sept. 29, for companies not covered by the earlier July 31 implementation date. The tariffs follow a Commerce Department investigation that found U.S. dependence on imported pharmaceuticals and pharmaceutical ingredients threatened to impair national security.” * * *
    • “Companies with qualifying most-favored-nation pricing and onshoring agreements with the administration receive a zero tariff rate through Jan. 20, 2029. As of an Aug. 31 White House announcement, all 17 Annex III companies, including AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer and Sanofi, have signed MFN deals, meaning none currently pay the tariff.”

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

  • Per an OPM news release,
    • The White House Task Force to Eliminate Fraud and the US Office of Personnel Management (OPM) today announced more than $500 million in anti-fraud savings for calendar year 2025.
    • The results cover the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) Programs. $237.7 million was saved from claims stopped or reduced before payment, and an additional $271.9 million in losses were prevented due to changes in billing and policy.  An additional $21.9 million were recovered after payment. This work was done in coordination with the Special Investigation Units of the FEHB and PSHB Carrier organizations that administer the health plans.
    • “Fraud in federal health benefits programs drives up costs for employees, retirees, and taxpayers,” OPM Director Scott Kupor said. “These results demonstrate the importance of strong carrier oversight, better data sharing, and earlier detection. Working with Vice President Vance and the White House Task Force to Eliminate Fraud, OPM is strengthening accountability and protecting the premiums paid by enrollees and the federal government.”
  • Fox News adds,
    • “Kupor’s previous experience working with artificial intelligence has led to his name being floated to serve as the AI czar in the Trump administration – a role cast into the spotlight as data center development and artificial intelligence have become midterm election talking points.” * * *
    • “When asked about whether he has had any conversations with the White House about the role, Kupor said he had seen the reports he was being floated, and discussed President Donald Trump’s views on artificial intelligence broadly.
    • “I’ve read all the same reports you’ve read and don’t have anything to add there,” he said. “What the president has said is exactly 100% right, which is that AI is the most important piece of technology that will determine economic growth for us, national security, sovereignty for our country.
    • “One of the things that I know, again, having spent all my life in the venture world, is there is no limit to the intellect and inventiveness of entrepreneurs in this country. And we just need to make sure that the conditions around, you know, regulatory controls and others continue to allow the U.S. to flourish in the way that it’s always done.”
    • “Kupor did not rule out accepting the role if Trump should offer it to him, saying that while he is focused on his job as director of the agency, he serves “at the will of the president.”
    • “Reports had suggested that Treasury Secretary Scott Bessent was being considered for the AI czar position, but last week Trump said he would not be selecting him for the role.”

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

  • The Hill reports,
    • “If you are one of millions of Americans taking medication to lower blood pressure, you may want to check the label.
    • “Inventia Healthcare Limited, based in Mumbai, India, is voluntarily recalling 13,567 bottles of chlorthalidone tablets that may not dissolve properly, potentially lowering the dosage that gets absorbed by the body. The bottles of 25 mg tablets being recalled nationwide have the batch number RISA24002 and an expiration date of March 2027.”
  • Cardiovascular Business relates,
    • “Tempus AI has received U.S. Food and Drug Administration (FDA) clearance for a new artificial intelligence (AI) tool designed to evaluate standard 12-lead resting electrocardiograms (ECGs) for signs of undiagnosed mitral regurgitation (MR). 
    • “The newly cleared software, Tempus ECG-MR, identifies signs of moderate or severe MR and then flags clinicians to ensure the patient receives follow-up medical imaging as needed. It was built to assess diagnostic ECG recordings of any patients 65 years old or older who face a risk of developing cardiovascular disease.  
    • “A standard ECG contains far more information than we have traditionally been able to use,” Brandon Fornwalt, MD, PhD, senior vice president of cardiology at Tempus, said in a statement. “With the fourth FDA-cleared Tempus ECG-AI product, we’re building a growing portfolio that can identify signals across numerous types of heart and vascular disease from the same ECG, helping provide clinicians with more actionable information from a test already embedded in everyday care.”

From the public health and medical/Rx research front,

  • Beckers Clinical Leadership reports,
    • “The infant mortality gap between Black and white babies in the U.S. increased between 2020 and 2024, with sudden unexpected infant death identified as the largest single contributor to the disparity, according to a study published Sept. 22 in JAMA Network Open.
    • “Researchers analyzed federal birth and infant death records covering nearly 58 million live births and 366,384 infant deaths from 2003 to 2024 to determine the factors behind the Black-white infant mortality gap.” * * *
    • “This study provides evidence that there is an acute crisis right now in sudden unexplained infant death, a category of cause of death that we assumed we got under control a long time ago,” Leslie Root, PhD, study co-author and assistant research professor at the University of Colorado Boulder’s Institute of Behavioral Science, said in a Sept. 23 news release.” 
  • Health Day relates,
    • “A powerful new lab-made opioid is moving through the illegal U.S. drug supply, and federal officials warn it could keep spreading. 
    • “The drug, called cychlorphine, may be up to 10 times stronger than fentanyl, according to the White House Office of National Drug Control Policy (ONDCP).
    • “In an April 30 drug threat notice, the office said cychlorphine had turned up in every region of the country. It was most common in Ohio, Texas and Tennessee.
    • “As of that notice, at least 55 deaths nationwide had been linked to the drug in 2025 and 2026.”
  • and
    • “A diagnosis of type 2 diabetes at a young age is much more likely in people who have autism or attention deficit hyperactivity disorder (ADHD), new research says.
    • “More than 14% of people diagnosed with type 2 diabetes before the age of 20 had an ADHD diagnosis, compared to close to 7% of people of similar age without diabetes. That’s more than double the number, findings being presented at a conference in Italy this week show. 
    • “As for autism, 5.7% of people diagnosed with type 2 diabetes before the age of 20 also had the neurodivergent condition, the study found.”
  • MedPage Today tells us,
    • “Hearing loss is considered a key modifiable risk factor for dementia.
    • “Hearing aids did not reduce progression from mild cognitive impairment to dementia in the CHOICE trial, but cognitive improvement occurred more often with their use.
    • “Low dementia conversion rates in this study underpowered conclusions, making replication and confirmation essential.”
  • Cardiovascular Business adds,
    • “When adults with type 2 diabetes are already being treated 1-mg doses of semaglutide, moving to a 2-mg dose is associated with better cardiovascular outcomes than switching to tirzepatide. That was the primary takeaway from new data presented at the European Association for the Study of Diabetes Annual Meeting 2026 in Milan, Italy.
    • “Researchers explored real-world data from more than 600,000 adults with type 2 diabetes who were receiving once-weekly injections of semaglutide at 1 mg per dose. While 67.2% of patients stayed on that exact same dose, 29.2% made the move to a 2-mg dose of semaglutide. Another 3.6% of patients, meanwhile, switched to taking up to 15 mg of tirzepatide per dose. The number of patients moving to a stronger dose or switching to tirzepatide did increase over time. 
    • “Overall, the study’s authors found that the higher semaglutide dose was associated with a 6% lower risk of major adverse cardiovascular events—an outcome that includes heart attack, stroke and all-cause mortality—than tirzepatide.” 
  • Per Genetic Engineering and Biotechnology News,
    • “Researchers at Washington University School of Medicine in St. Louis have developed a potential antibody-based approach to reducing neurodegeneration in diseases known as tauopathies, including Alzheimer’s disease. Studying mice with Alzheimer’s-like tau protein accumulation in their brains, the team showed that injecting the animals with an antibody to a protein called CXCR3 over several months blocked the route used by T cells to get into the brain, reducing the number of those cells in the brain by about half.
    • “The treated mice kept roughly 40% more tissue in memory centers of the brain and did better on a memory test compared with untreated mice—even though the levels of tau in their brains didn’t change. “In tauopathies, including Alzheimer’s disease, there’s no treatment right now that actually decreases neurodegeneration,” said David M. Holtzman, MD, the Barbara Burton and Reuben M. Morriss III Distinguished Professor in WashU Medicine’s Department of Neurology. “If we can show that we’re really decreasing brain cell death, it’s certainly worth trying to pursue that pathway to prevent the most devastating consequences of these diseases.”
    • “Holtzman is senior author of the team’s published paper in Neuron, titled “Peripheral CXCR3 blockade mitigates T cell infiltration and neurodegeneration in a mouse model of tauopathy,” in which they concluded “Our study defines the CXCR3 axis as a critical target that, when blocked, mitigates CD4+ and CD8+ T cell infiltration and confers neuroprotection in a model of tau-mediated neurodegeneration in vivo without influencing levels of soluble or insoluble tau.”
  • Per STAT News,
    • “An experimental gene therapy for Huntington’s disease, developed by the biotech company UniQure, continued to slow the progression of the neurodegenerative disease four years after it was surgically implanted into the brains of patients, the company reported Tuesday. 
    • “However, the magnitude of the treatment’s benefit has waned compared to a similar analysis conducted one year ago, which may raise questions about its durability just as the Food and Drug Administration begins to review UniQure’s marketing application.” 
  • Per BioPharma Dive,
    • “A CAR-T treatment from Adicet Bio has shown in human testing the potential to drive lupus into remission, providing early but notable evidence that therapies like it could be useful in treating autoimmune conditions.
    • “After a year of follow-up in an early-stage trial, 50% of lupus nephritis patients treated with Adicet’s therapy and evaluable for efficacy had a “complete” kidney response to treatment and 54% met a widely used statistical criteria for remission. All of those patients, who had previously tried multiple other treatments, stopped using immunosuppressive drugs.
    • “Adicet also noted that there were no serious cases of cytokine release syndrome or instances of neurological side effects, both of which are concerns with cell therapy treatments. The company intends to start up a pivotal study in lupus in the fourth quarter.” 

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

  • Beckers Hospital Review reports,
    • “Bloomington, Minn.-based HealthPartners and Duluth, Minn.-based Essentia Health announced Sept. 29 that their boards approved an agreement to combine, forming a nonprofit system with 22 hospitals, more than 135 clinics, 6,000 clinicians and 45,000 colleagues.
    • “The combined organization will be called HealthPartners and led by HealthPartners President and CEO Andrea Walsh. David Herman, MD, CEO of Essentia since 2015, will serve as president of combined clinical care group operations, and Essentia facilities will keep the Essentia Health name while operations are integrated.
    • “No money is changing hands. The organizations will combine their assets under a single community-based board and expect the combination to be effective Jan. 1, pending a Minnesota public interest review and federal filings.” 
  • and
    • “Kansas City, Kan.-based The University of Kansas Health System has signed a definitive agreement to acquire full ownership of St. Francis Campus and its affiliated care sites in Topeka from Brentwood, Tenn.-based Ardent Health.”
  • and
    • Los Angeles-based Cedars-Sinai Health System recorded operating income of $261 million (2.8% margin) for fiscal year 2026, compared with operating income of $239 million (2.8% margin) in fiscal 2025, according to its Sept. 25 financial report. 
  • Per Healthcare Dive,
    • “Oura said Tuesday that it will delay its planned initial public offering due to market uncertainty.
    • “The smart ring maker said in May that it confidentially filed for an IPO, and recently revealed that it sought to raise up to $2.2 billion in the offering. The company has reached profitability, and its revenue has grown over the last three years, according to Oura’s prospectus. The company said it expects revenue to grow 90% year over year for its fiscal 2026; Oura reported $907.9 million in revenue in its 2025 fiscal year. The company has 5.7 million paid members.
    • “We aim to deliver an extraordinary IPO for our employees and investors and we have the luxury of choosing our moment,” CEO Tom Hale said in a statement. “In the meantime, we will execute against the opportunities ahead.”
  •   and
    • “Name: Robert Hunter
    • “Previous title: CEO of government programs, UnitedHealthcare
    • “New title: President, UnitedHealthcare
    • “Hunter, who has held a variety of roles at UnitedHealthcare over the past 15 years, will take on the role of president of Minnesota-based UnitedHealth’s payer arm, he announced in a LinkedIn post on Monday. 
    • “Hunter will focus on helping UnitedHealthcare, the largest insurer in the U.S., escalate its “modernization agenda,” toward “a future where healthcare is more connected, easier to navigate and simpler to understand,” he said in the LinkedIn post. The company is in the middle of an effort to streamline and modernize patients’ digital experience with the insurer.”
  • The Wall Street Journal relates,
    • “Novo Nordisk NOVO.B has signed a licensing deal for a weight-loss treatment being developed by Hengrui Pharma that could be worth up to $2.6 billion.
    • “The Danish drugmaker will pay China-based Hengrui $300 million upfront, with the rest of the potential deal value tied to milestones.
    • “Novo will obtain exclusive rights to develop, manufacture and commercialize HRS-1596 globally, excluding mainland China, Hong Kong, Macau and Taiwan. Hengrui is also eligible to receive royalties based on sales of the drug within the licensed territory.
    • “The move is in line with Novo’s efforts to continuously advance its pipeline across obesity, diabetes and other cardiometabolic diseases, said Martin Holst Lange, chief scientific officer at Novo.”
  • Fierce Healthcare tells us,
    • “Digital health company Waltz Health is teaming up with drugmaker Fresenius Kabi to support direct-to-employer efforts for key biosimilar medications.
    • “Through the partnership, commercial employers, health plans and pharmacy benefit managers can access transparent pricing information for three therapeutic categories: rheumatology, dermatology and gastroenterology. The agreement encompasses three FK biosimilars, which are interchangeable with popular branded drugs Humira, Stelara and Actemra.
    • “Teaming with Fresenius makes for Waltz’s first expansion to its direct-to-employer offering, which initially partnered with Novo Nordisk and Eli Lilly on GLP-1s and went live at the beginning of this year.
    • “Jeff Park, president of Waltz Health, told Fierce Healthcare that while direct-to-consumer platforms like the White House’s Trump Rx have grabbed the lion’s share of attention, there’s significant opportunity in the direct-to-employer space to address affordability and access.”
  • Beckers Hospital Review lets us know,
    • “Elevance Health plans to require hospitals to identify the physical location where care was provided on billing forms and adjust payments for off-campus services accordingly.
    • “The insurer said Sept. 29 the new policies will apply across its commercial, Medicare Advantage and Medicaid plans and are designed to address situations where care delivered at off-campus locations is billed at higher hospital outpatient rates. Elevance said it is the first commercial payer to go public with requiring physical location data on claims and tie reimbursement to that information. The company plans to roll the policies out through the end of 2027.
    • “Catherine Gaffigan, MD, president of health solutions at Elevance, announced the change during a Tuesday morning panel at the MAHA Summit in Washington, D.C., where she appeared alongside leadership from UnitedHealth, AHIP and CMS.
    • “Patients and employers should be able to trust that healthcare bills accurately reflect where care was provided,” Dr. Gaffigan said in a news release.”
  • and
    • “Hospital outpatient departments were paid an average of 102% more per unit than physician offices for the same physician-administered medications, a premium that adds up to about $12.7 billion a year in employer health spending, according to new research from the Washington, D.C.-based Employee Benefit Research Institute.
    • “If HOPDs were reimbursed at physician-office rates, employers and workers could save about $12.7 billion annually, or roughly $101 per covered member, according to a Sept. 28 news release. The analysis examined 2023-24 commercial claims for 106 of the highest-spending physician-administered outpatient drugs, which accounted for about 51% of claims and 77% of spending in the category, using the Merative MarketScan Commercial Database for adults ages 18 to 64 with employment-based coverage.
    • “HOPDs received higher reimbursement for 93 of the 106 medications, with a median per-unit difference of 64%. The median annual difference was $5,531 per patient, reaching $135,306 for one oncology drug. About 59% of administrations occurred in HOPDs, compared with 31% in physician offices. The median HOPD markup on drugs from EBRI’s earlier analysis fell from 98% in 2019 to 70% in 2024, largely because physician-office reimbursement rose rather than HOPD rates falling.”
       
  • Beckers Health IT points out,
    • “AI can perform care represented in 16% to 22% of U.S. outpatient claims, according to an analysis from McKinsey & Co. That work accounts for 13% to 19% of outpatient spending.
    • “The Sept. 28 analysis of 2024 commercial, Medicare and Medicaid claims found that roughly 2 billion to 3 billion outpatient claims involve services clinical AI could potentially perform. McKinsey calls this category “discursive care,” meaning reasoning- and dialogue-based work such as intake, triage, diagnosis, referrals and follow-up that doesn’t require a hands-on exam.
    • Evaluation and management visits involving no additional care, or only low-complexity care, made up 11% to 15% of outpatient claims and 8% to 12% of spending. Interpretation of diagnostic or imaging results accounted for 5% to 7% of both claims and spending.
    • “Physician offices, clinics, virtual settings and urgent care are likely to see the largest share of AI-driven change, the authors said.”

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) today announced significant premium savings for millions of Medicare beneficiaries in 2027, with weighted average MA premiums projected to fall more than 16% from 2026 to 2027, and average prescription drug premiums in Medicare Advantage projected to plummet 38%. 
    • “Additionally, average premium for stand-alone Part D prescription drug plans is projected to rise by less than $1 per month in 2027. Despite speculation and misleading reports related to the appropriate sunsetting of the Part D Stabilization Demonstration Project, there is broad pricing stability across the Part D market.
    • “The strong 2027 outlook means Medicare beneficiaries will continue to have access to affordable coverage and broad plan choice without relying on billions of dollars in temporary subsidies to insurance companies. More than 99% of Medicare beneficiaries will have access to at least one Medicare Advantage Plan, while 97% will have access to 10 or more options. 
    • “CMS is releasing this key information ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2026, through December 7, 2026.” * * *
    • “To view premiums and costs for 2027 MA and Part D plans, visit: www.cms.gov/medicare/coverage/prescription-drug-coverage, and select the 2027 landscape source file under “Downloads.”
    • “For state-by-state information, important dates, and enrollment resources for MA and Part D in 2027, visit: https://www.cms.gov/files/document/2027-medicare-advantage-part-d-landscape-state-state-fact-sheets.pdf.” 
  • Beckers Hospital Review reports,
    • “The Comprehensive Care for Joint Replacement (CJR) model saved Medicare $180 million in its final three performance years without changing care quality, according to the program’s final evaluationreleased Sept. 24.
    • “CMS launched CJR in 2016 as its first mandatory bundled payment program, requiring hospitals in randomly selected cities to take financial responsibility for hip and knee replacements and the 90 days after discharge. Hospitals could earn a payment from CMS or owe money back depending on whether episode spending came in under or over a target price. The model ended in December 2024. 
    • “The final report covered the three years after CMS extended and reworked the model (October 2021 through December 2024). During that stretch, 321 hospitals across 34 metro areas performed about 143,000 joint replacements that counted toward the model, which was about 9% of all hospital-based joint replacements in the U.S. CMS had narrowed the model to higher-spending markets, so CJR patients tended to be somewhat older and sicker than joint replacement patients nationwide.”
  • and
    • “The Trump administration is developing an initiative aimed at moving production of 86 essential medicines to the U.S. within 18 months, according to a Sept. 25 Bloomberg report.
    • “Under the initiative, the Office of Management and Budget would solicit proposals from the healthcare industry on opportunities to move production of drugs on the list to the U.S., according to the report. A committee would identify and act on industry proposals.
    • “The effort cites “national security” and aims to reduce or eliminate dependence on medicines produced by foreign entities of concern, including China, Russia, Iran and North Korea, according to an OMB document cited by Bloomberg.
    • “The initiative builds on broader federal efforts to strengthen domestic supplies of critical drugs. The Economic Development Administration put $15.97 million toward a Civica-led project to build a fully domestic supply chain for four sterile injectables. Nine drugmakers that signed most-favored-nation pricing agreements with the administration this month also committed to invest at least $19.6 billion collectively in U.S. manufacturing.”
  • Beckers Payer Issues relates,
    • “House Democrats have drafted an 84-page health policy agenda outlining what the party would pursue if it wins a House majority in November, according to a Sept. 25 report from Politico, which first obtained the document.
    • “The new agenda follows reports earlier this month that the caucus was privately discussing a broader expansion of the Medicare program, along with policies aimed at breaking up vertically integrated healthcare companies such as UnitedHealth Group and CVS Health.”
  • and
    • “Medicare Advantage plan choice will fall in more than half of states in 2027, even as CMS projects lower average premiums and a nearly unchanged number of available plans nationwide.
    • “The decline follows widespread disruption in 2026, when as many as 2.9 million MA enrollees had to find new coverage after their plans were discontinued or the insurer exited the market. Individual insurers have signaled a similar pullback for next year, with Humana saying in July that its 2027 plan exits are expected to affect about 600,000 members.”
  • Beckers Hospital Review adds,
    • “Researchers at Yale University have outlined 10 new policy proposals they say could save billions in healthcare spending, targeting Medicare Advantage payments, site-neutral payments, drug costs, nursing home care and other areas.
    • “Nine of the proposals carry annual savings estimates that together range from about $70 billion to $84 billion, while the remaining proposal is estimated to save households $44 to $58 a month. 
    • “The proposals are the latest additions to the Yale Health Care Affordability Lab’s 1% Steps project, which now includes 23 policies with estimated annual savings of about $450 billion, or roughly 8% of the $5.5 trillion the U.S. spends on healthcare annually, according to a Sept. 28 news release. The lab cautioned that the total is not a Congressional Budget Office-style estimate and does not account for potential interactions among the proposals.
    • “None of these ideas alone will fix the American health care system, but stacked together, these targeted reforms add up to substantial savings,” Zack Cooper, PhD, director of the lab, said in the release.”
  • HR Dive lets us know,
    • “The U.S. Department of Labor is trying to help workplaces prepare for opioid-related overdoses in the workplace, according to a news release issued Thursday. 
    • “DOL’s Occupational Safety and Health Administration released a fact sheet Thursday that “provides practical information that focuses on empowering workplaces to recognize the signs of an overdose and act immediately.” 
    • “The guidance comes as employers grapple with drug use among employees, with some reports showing nearly 20% of workers use some kind of substance.”

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

  • Federal News Network reports,
    • “As agencies walk back the Trump administration’s controversial essay question from federal job postings, the Office of Personnel Management is directing them to replace it with a new prompt.
    • ‘Agencies must now include a question stating, “In this role, you will be expected to professionally and efficiently implement executive direction. Provide an example where you implemented leadership direction on a strategy or policy decision that differed from your own recommendation.”
    • “A Sept. 18 memo from OPM told agencies to begin including the new question on all upcoming federal job announcements. It replaces a prompt from the Trump administration that previously asked applicants to name a few executive orders or policy initiatives “significant” to them and explain how they would help implement those orders if hired.
    • “Agencies are expected to include OPM’s replacement question on job announcements that close on or after Sept. 26. So far, about 2,400 job announcements contain the revised question, OPM said Friday in a court filing.”

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

  • STAT News reports,
    • “The FDA has approved AbbVie’s once-daily Parkinson’s pill, tavapadon, to be sold as Juvmo. The drug is part of its $8.7 billion acquisition of Cerevel Therapeutics. The dopamine receptor agonist was approved for adults with Parkinson’s based on a late-stage study that showed the drug helped improve symptoms, Reuters writes. 
    • “AbbVie has said it sees more than $5 billion in combined sales from its Parkinson’s portfolio, though Citi analysts have cautioned that Juvmo’s uptake could be gradual as Medicare coverage negotiations play out.”
  • Fierce Pharma relates,
    • “Roche’s Gazyva just increased its foothold in the autoimmune market with a fresh FDA approval, becoming the first new treatment option in 70 years for patients with idiopathic nephrotic syndrome (INS).
    • “The regulator cleared the anti-CD20 monoclonal antibody to reduce the risk of relapse in adults and children 2 and older with frequently relapsing or steroid-dependent, childhood-onset INS who are in complete remission.
    • “The FDA green light, Gazyva’s second autoimmune indication in less than 12 months, cementing the 2013 cancer drug’s second act in immune-mediated diseases.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that causes symptoms, such as rapid heart rate, increased blood pressure and adverse effects on metabolism) in patients with MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome. Emcitate is the first therapy approved by the FDA to treat symptoms of this very rare, devastating genetic disease. This approval reflects the FDA’s dedication to patients with rare genetic diseases, many of whom have serious unmet medical needs.
    • “Until now, patients living with MCT8 deficiency and their families had no FDA-approved treatment option,” said Marina Zemskova, M.D., Deputy Director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research. “Emcitate’s approval reflects the FDA’s deep commitment to patients with rare conditions who are in need of meaningful treatment options.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration last week released a draft guidancedocument spelling out what the agency wants to see in premarket submissions for robotically assisted surgical devices.
    • “The 50-page document details criteria for system stability and latency, instrument motion and position control, visualization, software, wireless technology, cybersecurity, sterilization, clinical data, labeling, training and more.
    • “The agency also said it will hold a two-day public workshop on Dec. 2-3 focused on evaluating the benefits and risks of robotic medical devices with autonomous or remote teleoperation capabilities.”

From the judicial front,

  • Beckers Behavioral Health reports,
    • “A federal jury in Fort Worth, Texas, convicted Kevin Curry, 64, of nearby Frisco on Sept. 24 in a $26 million healthcare fraud, kickbacks and money laundering scheme.
    • “Mr. Curry billed TRICARE, the military’s health program, for transcranial magnetic stimulation therapy that was medically unnecessary or not provided, according to a Sept. 25 news release from the Department of Justice.”

From the public health and medical / Rx research front,

  • Beckers Behavioral Health reports,
    • “Breast and prostate cancer incidence is rising among people of every race and ethnicity in the U.S., while lung cancer incidence and death rates are dropping sharply, according to the CDC’s “Annual Report to the Nation on the Status of Cancer,” published Sept. 22 in Cancer.
    • “Researchers analyzed data from population-based cancer registries and the National Center for Health Statistics’ National Vital Statistics System to track cancer incidence through 2022 and death rates through 2023 by cancer type, sex, race and ethnicity and age.
    • “The CDC report follows the American Association for Cancer Research’s 16th annual “Cancer Progress Report,” which found the U.S. cancer death rate declined 35% between 2015 and 2024.
    • “The decline in cancer deaths was driven largely by “accelerated progress against lung cancer,” the CDC said in a Sept. 22 news release.”
  • The New York Times relates,
    • “More than 50 new cases of measles have been reported in Pennsylvania since Wednesday, state health officials said, as efforts continue to combat an outbreak that has spread across the state.
    • “The 55 new cases, reported by the Pennsylvania Department of Health in a statement on Friday, bring the total number of cases to 890 across 39 counties so far this year.
    • “The outbreak has led to 173 hospitalizations and four measles-associated deaths, according to the department.
    • “While daily numbers fluctuate,” the department said, “tracking these trends provides Pennsylvanians and health care providers with visibility into community transmission across the Commonwealth and helps inform the department’s ongoing response.”
  • STAT News tells us,
    • “Metal mixtures found in the leftover smoke, ash and debris from the deadly 2023 Maui wildfires were harmful to the lung health of people living nearby long after the burning ended, a new study says.
    • “The work shows that major wildfires, which are worsening with the planet’s warming, could have lasting effects beyond immediate exposure.
    • “New research published in the journal Proceedings of the National Academy of Sciences on Monday found higher metal levels, associated with respiratory harm, in nearby residents up to a year and a half after the fires.”
    • “As part of the Maui Wildfire Exposure Study, one of the largest postfire investigations in the country, University of Hawai‘i researchers studied the urine of 1,400 adults. They found substantially elevated concentrations of metals such as arsenic, cadmium, copper and antimony.”
  • MedPage Today asks “One Shot or Two? What to Know About HPV Vaccination Recommendations.”
    • — Guidance is evolving
  • Per Health Day,
    • “Cutting back on ultra-processed food could provide a boost to your mental health, a new pilot study says.
    • “People had less depression and anxiety after cutting their ultra-processed food intake by more than 85%, researchers reported Sept. 23 in JAMA Psychiatry.
    • “The results indicate that junk food “may harm your gut in ways that ripple up to your brain,” lead researcher Dr. Nyasha Chagwedera, an assistant professor of psychiatry and behavioral sciences at the University of California, San Francisco, said in a news release.”
  • Per Healio,
    • “Approximately one in four adults with hepatitis C virus infection who initiated treatment with direct-acting antivirals did not undergo follow-up RNA testing, according to a research letter published in JAMA Network Open.
    • “However, 90% of that unmonitored population had been prescribed at least 56 days of DAA therapy, potentially leaving cured individuals unaccounted for and highlighting a notable gap in HCV surveillance efforts.
    • “Measuring care outcomes is essential to monitoring progress toward hepatitis C elimination,” Hasan Symum, PhD, of the CDC’s division of viral hepatitis, and colleagues wrote.”
  • BioPharma Dive informs us,
    • “Shares in eye-drug developer Kodiak Sciences more than doubled Monday after the company said its two drugs for macular degenerationsucceeded in a Phase 3 clinical trial that compared them with Regeneron Pharmaceuticals’ Eylea.
    • “Kodiak’s Zenkuda was able to match Eylea’s eyesight improvement using an individualized dosing strategy that allowed more than half of trial participants to receive injections only once every six months compared with once every eight weeks for Eylea, Kodiak said. The biotech’s second drug, called tabirafusp alfa tedromer, also matched Eylea using an individualized dosing strategy.
    • :The company expects to ask the Food and Drug Administration for approval of Zenkuda in wet age-related macular degeneration, the condition treated in the trial reported Monday, along with two other eye disorders in the fourth quarter of 2026. The news marks a turnaround for Kodiak and Zenkuda, which failed to match Eylea in a trial that read out more than four years ago. Kodiak’s market value climbed by more than $3 billion
  • The Wall Street Journal notes,
    • Roche Holding ROP  said it stopped work on one of its obesity-drug candidates, after clinical-trial data suggested the medicine wouldn’t hit internal targets.
    • The Swiss drugmaker said it returned rights to the medicine, emugrobart, to its majority-owned business Chugai Pharmaceutical, which originally discovered the drug and licensed it to Roche.
    • “We have made the decision to discontinue development,” Roche’s pharmaceuticals chief executive, Teresa Graham, said at an event with investors in London on Monday. “We are returning that molecule to Chugai, and Chugai is looking to further development in [spinal muscular atrophy] as well as considering potential outlicensing opportunities.
    • “Roche had previously estimated the drug had potential to reach annual peak sales of between 1 billion and 2 billion Swiss francs ($1.21 billion-$2.41 billion). The company is also developing two obesity injections and a pill, and sees potential for each of them to exceed 3 billion francs in peak sales.”

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

  • Modern Healthcare reports,
    • “UConn Health’s proposed acquisitions of Bristol and Day Kimball hospitals have been delayed. “Farmington, Connecticut-based UConn said Friday it is committed to the deal but needs more time for due diligence and planning to ensure the facilities’ long-term financial sustainability.
  • STAT News relates,
    • “Blockbuster GLP-1 drugs have transformed the lives of millions of people. Lately, they’re undergoing a makeover of their own.
    • “Once promoted as tools to address obesity as a medical issue, GLP-1 drugs are increasingly being seen — and marketed — as a way to look and feel better generally. And, as the pioneer in the field, Novo Nordisk, in particular, has leaned into the shift.
    • “In advertisements around the world, the company has trotted out slogans like “Live lighter” and “Summer Glow Up.” On its website, Novo no longer labels its treatment, Wegovy, as a “weight management” drug or “anti-obesity” medicine, but instead as a “weight loss” drug. And the company now often refers to the people who take its drugs less as “patients” and more as “customers.”
    • “It’s a long way from the pitch Novo and its rival GLP-1 maker, Eli Lilly, once made — that obesity is a chronic biological disease, just like diabetes and heart disease, and the drugs don’t merely help people lose weight, but also improve health outcomes.
    • “The shift, observers note, is no accident.” 
  • Physicians Practice tells us,
    • “About a third of medical groups have used AI to build their own software, and many of those homegrown tools sit in the parts of the practice that handle patient data: scheduling, prior authorization, denials and patient-facing workflows.
    • “A Sept. 22 MGMA Stat poll of 228 medical group leaders found 34 percent have built an app or workflow tool in-house using AI, according to MGMA’s write-up of the results. Another 8 percent tried but never launched a project, 54 percent haven’t tried and 10 percent weren’t sure.
    • “The approach, often called “vibe coding,” lets someone describe what they want in plain language and have a generative AI tool write the code. It puts working software within reach of physicians and administrators who have never written a line of it.
    • “Respondents described building tools for scheduling, prior authorization and denial work, internal dashboards, inventory management, call handling, recalls and staff tracking. Some projects moved closer to protected health information, including charting support, biologic-ordering workflows, coding and audit guidance, and patient-facing tools.”
  • Healthcare IT News adds,
    • “Artificial intelligence capabilities are creating a new operational reality in healthcare right now and are needed to alleviate immense systemic pressures, said Seema Verma, general manager of Oracle Health and Life Sciences, on Wednesday as she opened the 2026 Oracle Health and Life Sciences Summit in Orlando, Florida.
    • “Verma announced a series of specifically engineered AI agents for clinical workflows, revenue cycle management and life sciences in her opening keynote address.
    • “These are not isolated product announcements,” she explained. “They are pieces of a much larger transformation across payers, providers, pharma and for all patients.”

Weekend update

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

Simplicity is a virtue.

From Washington, DC

  • The Senate will be in session this week on Capitol Hill for Committee business and floor voting. The Senate will join the House of Representatives on the election campaign trail at the end of the week.
  • Roll Call discusses anticipated Senate activities this week.
  • The U.S. Supreme Court will gear up for its October 2026 term this week. On Friday, the Court will release its long list of orders on cert petititions and more that have piled up since June.

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

  • The FEHBlog expects that OPM will publicize 2027 FEHB and PSHB premiums sometime over the next two weeks. Last year, OPM publicized 2026 premiums on October 9, 2025.

From the public health and medical / Rx research front,

  • Healio reports,
    • “Autism prevalence has not significantly changed since 2005, according to a large population-based study of schoolchildren in South Korea.
    • “HHS Secretary Robert F. Kennedy Jr. and other U.S. health officials have claimed there is an autism “epidemic,” blaming vaccines, acetaminophen and environmental toxins as potential causes for the rise in diagnoses.” * * *
    • “Research has shown that there has been an increase in autism diagnoses, but experts say that is due to earlier detection and expanded diagnostic criteria. Young Shin Kim, MD, MS, MPH, PhD, a developmental psychopathologist at University of Texas Dell Medical School, told Healio that it is difficult to interpret data about autism prevalence because of the large variation in how those data are collected and reported in different states, countries and health systems. * * *
    • “Kim and colleagues investigated autism prevalence in South Korea. Elementary education is mandatory in South Korea, and Kim said homeschooling is rare, which allowed the researchers to screen nearly every child in the country when they started school.” * * *
    • “Our findings do not support interpreting increases in reported autism prevalence as evidence of an ‘autism epidemic,’” Kim said. “Much of the increase may reflect improved awareness, broader identification and the recognition of children who were previously missed.”
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) today [September 24] launched Linked Discoveries, an experimental tool designed to help scientists more easily see how an individual research finding relates to the larger body of biomedical evidence. From a citation in PubMed, users can use the Linked Discoveries tool to explore a “neighborhood” of publications closely related to that article, including replication studies. More than 29 million PubMed publications are represented in Linked Discoveries at launch. 
    • “Developed by NIH’s National Library of Medicine (NLM), which oversees PubMed, Linked Discoveries is an early product of NIH’s agency-wide initiative to strengthen replication and reproducibility in NIH-funded research. In particular, this tool seeks to address the difficulty of determining how a finding fits within the existing evidence. Relevant studies and other research information may be dispersed across different resources, and traditional approaches to finding scientific literature can favor already prominent or frequently cited work. Linked Discoveries begins to address that challenge by giving researchers a more connected view of publications related to a particular study.” * * *
  • Health Day relates,
    • “A well-known brain-healthy diet appears to ward off decline and dementia by protecting a person’s arteries, a new study says.
    • “People who followed the MIND diet had healthier blood vessels in their brains, contributing to larger brain sizes and better cognitive function, researchers report in the journal Alzheimer’s & Dementia.
    • “One of the most striking findings was that the relationship remained significant even after accounting for factors such as physical activity, body mass index, race and vascular disease,” said lead researcher Puja Agarwal, an assistant professor of internal medicine at Rush University in Chicago.
    • “This suggests that diet may have an independent role in supporting brain health,” she added in a news release.”
  • and
    • “Loneliness and social isolation can cost a person up to six years of healthy life, a new study says.
    • “Physical and mental health suffer when people feel lonely and become isolated, even if they largely stick to healthy habits, researchers reported recently in the journal Nature Communications.
    • “The two conditions are different. Social isolation refers to having few relationships or limited contact with others, while loneliness is a distressing feeling caused by a lack of meaningful connection, according to the National Council on Aging.
    • “In other words, people can be socially isolated but still not feel lonely if they are getting what they need from whatever connections they do have.” * * *
    • “Notably, a healthier lifestyle — diet, exercise, sleep and not smoking — narrowed the loss of disease-free years linked to social isolation, but did not significantly reduce the health risks of loneliness.
    • “The findings weren’t surprising to me,” Qi concluded. “Previous studies found that social isolation and loneliness are related to mortality, especially premature mortality, and this study provides additional evidence.”

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

  • The Business Group on Health considers “Why are Healthcare Costs So Difficult to Forecast?” 
    • “Explore why healthcare costs are increasingly difficult to forecast and how employers are responding to volatility with greater urgency and accountability.”
    • “Healthcare cost volatility is no longer a temporary disruption. It is becoming a defining feature of the healthcare landscape. After consecutive years of missing cost projections and facing record-high increases, employers are confronting a fundamental question: Which new strategies and approaches do we need to deploy to address this persistent and volatile landscape? 
    • “The employers that thrive in this environment will be the ones willing to rethink how care is purchased, act with a sense of urgency, demand greater accountability from partners, and embrace disruption when it creates better outcomes. In a market defined by uncertainty, standing still may be the riskiest strategy of all.” 
  • The Hill reports,
    • “After analyzing claims data from 2021 to 2023, the personal finance site [MoneyGeek] found the average out-of-pocket cost of a vaginal delivery was $2,563 and a C-section was $3,071.
    • “These estimated totals include the cost of staying at the hospital, the line item charges for medication, and seeing different types of physicians (obstetricians, anesthesiologists, etc.).
    • “The states with the highest bills, surprisingly, are places often thought of having a low cost of living, like Nebraska, Oklahoma and South Dakota. Average deliveries in all three states can cost patients upwards of $2,500 out-of-pocket.” * * *
    • “Meanwhile, in Michigan, the average delivery costs $974 out-of-pocket. What accounts for such a big difference? In most cases, it comes down to what hospitals have negotiated with insurers, according to MoneyGeek.”
    • “As the California Health Care Foundation explains, differences in price between different hospitals has little to do with the quality of care received. It has more to do with how much competition there is in a market. 
    • “Decades of research shows that prices for inpatient and outpatient services — from C-sections to CT head scans — are higher when there is less competition,” write Kristof Stremikis and Catherine Teare. “This happens when hospitals, medical groups, or health plans merge or buy their competitors. With fewer choices, a big system in one area can set higher prices and anti-competitive contract terms.”
  • The Wall Street Journal lets us know “People Are Lining Up for Full-Body Scans. But Are They Necessary?”
    • “Neko Health, a Spotify founder’s preventative-health startup, opened its first U.S. clinic.”
    • [Neko Health] had amassed a wait list of around 25,000 New Yorkers before the location was announced, a company spokesperson said. It opened its doors on Thursday [September 24]. The Swedish brand is the brainchild of Spotify founder Daniel Ek and Hjalmar Nilsonne, Neko Health’s CEO.
    • “It is the latest in a wave of preventative-health companies hitting the U.S. market, pitching patients on the notion that more information can give them more control over their health. For $499, which people can use HSA or FSA funds to help cover, the “radiation-free” visit includes a skin examination with visual and thermal cameras, a cardiovascular assessment, a body-composition analysis and on-site blood-testing. That takes about 30 minutes, then a clinician will meet with patients for another 30 minutes to discuss the results. It aims to help people assess risk of skin cancer, cardiovascular disease and metabolic conditions.” * * *
    • Some medical professionals have criticized preventive MRIs as unnecessary. But their potential for early detection, even before symptoms arise, shouldn’t be dismissed, said Dr. Zahi Fayad, director of the Biomedical Engineering and Imaging Institute at the Icahn School of Medicine at Mount Sinai.
    • “We still need to learn which people benefit most, how often to scan them and whether earlier detection changes their long-term outcomes,” he said.” * * *
    • “He shared advice for patients interested in getting a scan: “First, tell me what you are hoping to learn. If there is a symptom or a strong family history, we should choose the test that addresses that concern.”
    • “He added, “Neither service should replace recommended cancer screening or attention to blood pressure, cholesterol, diabetes risk, exercise and smoking.”  

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the AI frontier front,

  • CNBC reports,
    • “Anthropic and OpenAI on Tuesday each announced new, less costly artificial intelligence models as both frontier labs continue to face stiff competition from cheaper, open-weight competitors.
    • “OpenAI introduced additional tiers to its GPT-6 family, with GPT-6 Sol and GPT-6 Luna, slashing the API prices by 50% compared with GPT-5.6 promotional pricing. 
    • Sol, which is a tier below Astra, is meant for more complex workloads like coding, while the company’s Luna offering is geared toward “high-volume tasks” such as extracting information or summarizing documents, the company wrote. 
    • “Anthropic unveiled Claude Opus 5.5 on Tuesday, its latest release in the new Claude 5.5 model family. The company described the latest release as a more token-efficient version that will cost around 40% less to run than the company’s Opus 5.
    • “One of the things we’re continuing to innovate on is how to make that thinking, how to make the answering more efficient, so it uses less tokens depending on your effort setting,” Dianne Penn, head of product management, research and labs at Anthropic, told CNBC in an interview. 
    • “The separate releases are the first to roll out since Anthropic CEO Dario Amodei called for an industrywide slowdown on developing advanced AI as the debate about model safety reached a fever pitch in recent weeks.’
  • The Wall Street Journal relates,
    • “A swarm of OpenAI agents accessed U.S. government websites as part of a monthslong incident during which tests conducted by the artificial-intelligence company went awry, leading to unexpected internet activity.
    • “The AI agents accessed the websites belonging to the Commerce Department and the Securities and Exchange Commission and engaged in activity that OpenAI described as “misaligned.” That is the word AI companies use to describe bad behavior by their agents. In this case the misalignment appears to have been aggressive web browsing.
    • “In the case of the SEC, OpenAI’s agents copied and posted public data—something they were not supposed to do. In the case of the Commerce Department, an agent accessed a U.S. Census data website using a programming interface that wasn’t intended for this purpose, OpenAI said.
    • “OpenAI’s revelation came after the AI research nonprofit Transluce alleged that OpenAI agents “used an array of gray-area tactics to probe U.S. Government websites,” and attempted a “rudimentary,” but unsuccessful hack of an Education Department website. This was reported earlier by the New York Times.”
  • Bleeping Computer adds,
    • “OpenAI has confirmed it’s aware of a new security incident in which its AI agents uploaded user-provided images to third-party image-hosting services.
    • “OpenAI says most users were not affected, as it could only identify 53 incidents where agents accidentally uploaded images to the internet.
    • “The disclosure comes from OpenAI’s broader investigation into misaligned agent behavior following the Hugging Face security incident.”
  • The Wall Street Journal notes,
    • “President Trump said on Saturday [August 19] he was launching a new unit focused on artificial intelligence after leading figures in the industry publicly sounded the alarm over the growing technology.
    • “I am forming the AI Force, much like I did Space Force, which has been a tremendous SUCCESS, in my First Term,” Trump said on Truth Social. He added he is also recruiting an AI “czar.” The president had appointed investor David Sacks as his AI and crypto czar before the businessman stepped down from that role to become co-chair of the president’s Council of Advisors on Science and Technology, a role in which he is still one of Trump’s top advisers on AI policy.
    • “Saturday marks the first time the president has suggested there could be a new federal government entity solely dedicated to AI, but it isn’t clear what role it would play. Several other units of the government work on tech policy including the White House Office of Science and Technology Policy, the Commerce Department and the Defense Department.

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “The Cybersecurity and Infrastructure Security Agency published a paper Wednesday that lays out its plan for improving the Common Vulnerabilities and Exposures (CVE) program, a contract for which nearly ended last year before a last-minute reprieve.
    • “The white paper outlines the components of a “Quality Era” for the program, widely used as the definitive clearinghouse for data on vulnerabilities in software and other products, even as the number of CVEs surges. 
    • “CISA remains committed to leading, growing and sustaining the CVE Program into the foreseeable future, just as we’ve done for more than 25 years without fail,” said Chris Butera, acting executive assistant director for cybersecurity. “Informed by CVE community feedback, this whitepaper communicates CISA’s effort to support and enable stronger participation and governance, a program-wide maturation effort.” * * *
    • “The plan calls for advancing data quality across four key dimensions: transparent and effective program governance, broad and active participation across the global software community, data infrastructure that supports CVE operational functions and reliable CVE record content. * * *
    • “Butera invited further feedback from the CVE community on the white paper, which stems from an earlier strategy document on the future of the program.
    • “Some CVE experts that CyberScoop spoke to were supportive of what CISA wants to achieve, but skeptical about elements of the white paper.”
  • and
    • “Nearly early nine out of 10 federal civilian executive branch agencies failed to meet last summer’s deadline to implement cloud security directives from the Cybersecurity and Infrastructure Security Agency, a watchdog report published Wednesday found.
    • “The conclusions from those results, according to the inspector general for the Department of Homeland Security: agencies “may encounter elevated security exposures that undermine the national cloud security posture and increase the likelihood of preventable cyberattacks and related threat,” and “CISA lacks the authority necessary to require full and timely implementation of Binding Operational Directives,” or BODs.
    • “The latter is a question that has surfaced before about CISA directives, which the agency uses to pressure agencies into improving their cyber defenses.” 
  • SC World tells us,
    • “The U.S. Cybersecurity and Infrastructure Security Agency (CISA) announced the launch of Vulnerability Information and Coordination Environment – New Technology (VINCE-NT) on Thursday [September 17], an upgraded, fully CISA-hosted system that will replace the original VINCE for coordinated vulnerability disclosure (CVD).
    • “VINCE has been used by researchers, suppliers and stakeholders since 2020 to coordinate the disclosure of cybersecurity vulnerabilities, and was originally sponsored by CISA and hosted by Carnegie Mellon University’s CERT Coordination Center (CERT/CC) under its Software Engineering Institute.
    • “The new VINCE-NT system, officially live as of Sept. 17, 2026, is now fully sponsored, hosted and managed by CISA and includes several improvements to streamline CVD, the agency said in an FAQ.”
  • Per a National Institutes of Standards and Technology news release,
    • “NIST has released the initial public draft of Special Publication (SP) 800-82r4 (Revision 4),  Guide to Operational Technology (OT) Security, which provides guidelines for improving the security of OT systems while addressing their unique performance, reliability, and safety requirements.” * * *
    • “Updates in this revision include:
      • “Expanded introduction to OT sectors to include Building Automation and Control Systems (BACS), Water and Wastewater Systems (WWS), food and agriculture, freight rail, maritime vessels, and Industrial Internet of Things (IIoT) and cloud convergence
      • “Restructured around the NIST Cybersecurity Framework (CSF) 2.0, including a reorganization of the previous risk management section to focus on the CSF Govern Function
      • “Expanded discussion of how OT risk management aligns with broader enterprise risk management, as described in NIST IR 8286r1
      • “Discussion of the adoption of the NIST Risk Management Framework (RMF) in Appendix F
      • “Expanded guidelines for implementing OT security controls, including asset management and network monitoring and detection
      • Security architecture guidelines focused on protecting system management functions and applying zero trust principles
    • “The comment period on this initial public draft is open now through November 30, 2026. See the publication details for a copy of the draft and instructions for submitting comments.”
  • Per a Justice Department news release,
    • “Ardit Kutleshi, 28, a Kosovar national, pleaded guilty [on September 24] to charges related to his creation and operation of Rydox, an illicit website and marketplace for cybercriminals to buy, sell and trade stolen personal information, and to access devices and other tools for carrying out cybercrime and fraud.” 
  • Cyberscoop points out,
    • “A 35-year-old Armenian national was sentenced to two years in prison for his involvement in a series of Ryuk ransomware attacks while living in Ukraine and Russia in 2019 and 2020, the Justice Department said Tuesday.
    • “Karen Vardanyan was extradited from Ukraine to the United States last year and pleaded guilty to computer fraud and conspiracy to commit fraud and extortion in July. Vardanyan’s sentencing, which also calls for about $1.2 million in restitution to victims, matches terms of a plea agreement he reached with prosecutors.
    • “Vardanyan and his co-conspirators’ victims include a Michigan-based company that paid a ransom of nearly $1.2 million in January 2020, a Watsonville, Oregon-based technology company that was attacked in December 2019 and a Texas-based school breached in February 2020, according to court records.”

From the cybersecurity breaches and vulnerabilities front,

  • Cybersecurity Dive reports,
    • “The FBI is investigating a cyberattack on its jobs portal after the cybercrime group ShinyHunters said it hacked the system and stole a vast trove of sensitive data from the bureau.
    • “The FBI is aware of a cyber-criminal enterprise group claiming a compromise of the FBIJobs.gov portal and alleged impact to FBI employee personally identifiable information (PII),” the bureau said in a statement on Wednesday [September 23]. “While the point of breach is still undetermined—whether a third-party or the FBI’s enterprise—we are actively and aggressively investigating this matter and working closely with those third-party providers that support FBIJobs.gov to mitigate any and all risk.” * * *
    • “ShinyHunters told 404 Media that it hacked into the jobs portal using a zero-day vulnerability in Oracle’s PeopleSoft human-resources platform, a tactic it has used before. The potentially wide-ranging breach highlights the supply chain risks facing organizations of all sizes and levels of sophistication. ShinyHunters specializes in supply chain attacks, and its intrusions have illuminated weaknesses in the security protocols at widely used software and infrastructure providers.”
  • and
    • “The healthcare and pharmaceutical sectors are facing a heightened risk of social-engineering attacks, according to cybersecurity researchers and threat intelligence experts.
    • “The Health Information Sharing and Analysis Center recently warned that the group ShinyHunters was using voice-phishing attacks to target the healthcare sector. The hackers used medical-themed impersonation domains to trick healthcare employees into exposing their credentials. 
    • “More than a dozen member organizations have been hit by social-engineering attacks over the past couple of months, Errol Weiss, chief security officer at Health-ISAC, told Cybersecurity Dive. The actors involved are using aggressive tactics to try to compromise targeted companies. 
    • “They’re pretty belligerent when it comes to getting somebody on the phone and convincing them they need to click on a password reset or an MFA reset,” Weiss said.”
  • Beckers Health IT adds,
    • “Home medical equipment provider AdaptHealth disclosed that a June cyberattack exposed personal and health information belonging to more than 4.1 million patients, according to a filing with the HHS Office for Civil Rights.
    • “The company said the breach stemmed from a social engineering attack that compromised a third-party contractor’s user session, giving a threat actor access to AdaptHealth’s cloud-based patient management and document storage systems. AdaptHealth first disclosed the intrusion in a July 2 SEC filing after the attacker contacted the company June 15 claiming to have stolen data.”
    • “In an Aug. 14 notice, AdaptHealth said the threat actor exfiltrated names, contact information, demographic data, health insurance information and health information, along with a password file tied to insurance billing. Social Security numbers, financial account information and payment card data were not affected, the company said.”
  • and
    • “Eskenazi Health is notifying patients of a data breach after an employee’s cloud-based work account was compromised through a phishing email that appeared to come from a trusted business contact.
    • “The Indianapolis-based health system discovered the unauthorized access July 27, according to a Sept. 25 notice. A forensic investigation determined the unauthorized access began June 3 and continued until Eskenazi Health terminated it July 27.
    • “The incident began after the email account of one of Eskenazi Health’s business contacts was compromised and used to send thousands of unauthorized emails to individuals in the contact’s address book. An Eskenazi Health employee received one of the messages, which appeared to contain a secure document notification.
    • “After the employee interacted with the link and completed the requested authentication process, an unauthorized individual gained access to the employee’s work account, according to the notice.”
  • CISA added ten known exploited vulnerabilities (KVE) to its catalog this week.
    • September 21, 2026
      • CVE-2026-7273 Zyxel GS1900 Series Switches Stack-Based Buffer Overflow Vulnerability
        • Aviatrix discusses this KVE here.
    • September 22, 2026
      • CVE-2026-85102 Check Point Multiple Products Improper Certificate Validation Vulnerability
      • CVE-2026-93616 Check Point Multiple Products Path Traversal Vulnerability
      • CVE-2026-93952 Arista VeloCloud Orchestrator Improper Input Validation Vulnerability
      • CVE-2026-94127 F5 BIG-IP APM Heap-based Buffer Overflow Vulnerability
        • Cybersecurity News discusses the Check Point KVEs here.
        • Bleeping Computer discusses the Arista KVE here.
        • SOC Prime discusses the F5 KVE here.
    • September 24, 2026
      • CVE-2026-5430 WSO2 Multiple Products Path Traversal Vulnerability
      • CVE-2026-71362 Adobe Commerce and Magento Incorrect Authorization Vulnerability
        • Cybersecurity News discusses the WS02 vulnerabilities here.
        • Recent Breaches discusses the Abode and Magento KVE here.
    • September 25, 2026
      • CVE-2026-65660 Microsoft SharePoint Code Injection Vulnerability
      • CVE-2026-67279 Mikrotik RouterOS Improper Enforcement of Behavioral Workflow Vulnerability
        • The Hacker News discusses the Microsoft KVE here.
        • Recent Breaches discusses the Mikrotik KVE here.
    • September 25, 2026
      • CVE-2026-87902 WordPress Core Remote File Inclusion Vulnerability
        • Recent Breaches discusses the WordPress KVE here.

From the ransomware front,

  • HIPAA Journal reports,
    • “A new analysis of ransomware activity reveals broad, consistent targeting pressure across the United States. Ransomware activity is not limited to any specific industry, with all sectors attacked to varying degrees. The analysis was conducted by the AI-driven cybersecurity and threat intelligence platform provider Anomali, with the findings published in its US Ransomware Industry Targeting Report.
    • “Anomali observed ransomware targeting across 8 industry sectors by 200 distinct ransomware entities, with its analysis showing that technology was the most targeted sector, followed by manufacturing and healthcare.
    • “Anomali looked at ransomware targeting across eight industry sectors – technology, manufacturing, healthcare, financial services, government public services, construction, education, and energy. There was in excess of 50% observed targeting presence in all eight sectors, with technology companies targeted by 172 of the 200 ransomware entities (86%), followed by manufacturing with 166 (83%), and healthcare in third place with 154 (77%).”
  • Infosecurity Magazine relates,
    • “A newly formed ransomware group has claimed that if its victims don’t give into their extortion demands and pay a ransom, that they will destroy their backup infrastructure, in a move which could prevent a targeted organization from operating entirely.
    • “Named n0n, the emergence of the ransomware crew has been detailed by cybersecurity researchers at CyberXTron. In a blog post published on September 23, researchers said activity by n0n was first spotted on September 18 and by September 22 the group’s Tor-hosted leak site had published information about over a dozen victims.
    • “The group operates on a double extortion model which has become highly popular and highly effective among ransomware threat groups.”
  • Kaspersky adds,
    • “Kaspersky’s Global Emergency Response Team (GERT) has published a new report analyzing a sophisticated new tactic in the Payload ransomware family. Discovered during an incident response at a manufacturing company in the Middle East, this attack demonstrates a major shift in cybercrime: the attackers took complete control of the company’s network and forced its computers to lock up, display ransom notes, and change desktop wallpapers – all without deploying a conventional ransomware encryptor.
    • “This incident illustrates one of the trends mentioned in Kaspersky’s State of Ransomware 2026 reportreleased earlier this year: attackers are increasingly moving away from traditional file encryption. Instead, they are adopting “encryptionless extortion” – focusing on immediate operational disruption and leaking sensitive, stolen data on the dark web rather than relying on cryptographic keys to squeeze payments out of victims.”
  • Bleeping Computer notes,
    • “The Clop ransomware gang has moved its data leak site to a new Tor address after confirming its previous server was compromised and defaced through an unpatched Grav CMS flaw that BleepingComputer has learned is an unauthenticated path traversal vulnerability.
    • “The Clop leak site was breached earlier this month by the ShinyHunters extortion gang, which first uploaded a small text file and later replaced the site with a full-page defacement displaying its Umbreon Pokémon logo and a link to its own data leak site.”

From the cybersecurity business and defenses front,

  • The American Hospital Association News reports,
    • “The FBI and the Cybersecurity and Infrastructure Security Agency have released a fact sheet for critical infrastructure organizations on ways to reduce risk and minimize vulnerabilities when working with third-party hardware and software networks designed to monitor and automate physical processes for control systems and devices, such as pumps, sensors and industrial computers for operating essential equipment. In healthcare, such applications are common throughout facilities and include climate control, building automation, access control and other systems. Such operational technology systems are essential for maintaining clinical operations. The agencies said that organizations should maintain caution when granting third-party networks high levels of access or control over such operations, allowing only the minimum access necessary to perform their assigned tasks. Granting additional access could expose owners and operators to malicious cyber actors attempting to exploit and compromise equipment and critical functions. The fact sheet includes recommendations for organizations to assess and reduce risk of attacks.”
  • Cybersecurity Dive relates,
    • “Google-owned cloud security firm Wiz said on Thursday that it is using AI tools to identify vulnerabilities in internet-facing critical infrastructure, from operational technology maintained by under-resourced utilities to software packages that are foundational to online activity.
    • “Where authorized, we will use the Wiz Red Agent and additional internal AI research capabilities to examine publicly facing websites, APIs, and applications,” Wiz’s Ami Luttwak and Gal Nagli wrote in a blog post about the company’s Scan for Good initiative. “This work will help organizations find and fix critical exposures before attackers do, allowing them to stay ahead of adversaries as AI capabilities advance.”
  • and
    • “Nearly nine out of 10 industrial security leaders said they believe their companies could contain a cyber incident, and nearly half of those same companies experienced a breach or attack over the past 12 months, according to a report released Tuesday by Rockwell Automation. 
    • “More than one-third of industrial firms described cyber risk as the top obstacle to growth. 
    • The report highlights a continued resilience gap in industrial environments, where maintaining operational technology is critical. More than 60% of industrial firms have invested in various security technologies, including asset inventory, intruder detection and secure remote access.” * * *
    • “A separate benchmark report out Tuesday from Honeywell Technologies also showed a significant gap in OT security readiness. The report, based on responses from more than 600 IT security leaders globally, showed only one in five organizations had complete visibility into their OT assets.” 
  • and
    • “As the cyber insurance industry has worked to regain momentum against a rising wave of cyber risk, the rapid emergence of AI has put increased pressure on determining whether the sector could afford to cover potentially billions in losses from a catastrophic event. 
    • “After months of uncertainty, Beazley, a leading specialist in the cyber sector, on Thursday confirmed it would provide “AI-afffirmative cover,” meaning it would cover losses stemming from an incident, even if the attacker utilized artificial intelligence.” 
  • Help Net Security notes,
    • “To help security practitioners catch malware that leans on AI, researchers from Cisco Talos shared an open-source framework that they hope will be used to classify and analyze the threat. The tool, called CAIRN, works entirely from metadata pulled off files. No downloading the malware, no running it.”
  • Dark Reading explains that “Stopping IT Worker Scams Requires Revamped HR Process.”
    • “Training human-resource managers in the latest tactics and warning signs goes a long way toward blunting the threat, but automated analysis can help even more.”
  • Here is a link to Dark Reading’s CISO Corner.