Thursday report

Congress

Thursday report

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

Simplicity is a virtue

From Washington, DC

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

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

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

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

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

From the Medicare Advantage front,

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

No Surprises Act News,

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

From the fraud, waste and abuse front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Midweek update

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

Simplicity is a virtue.

From Washington, DC

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

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

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

No Surprises Act News

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

From the fraud, waste, and abuse front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Nobel Prize

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

Weekend update

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

Simplicity is a virtue.

From Washington, DC

  • Both Houses of Congress have left Capitol Hill for the campaign trail.
  • SCOTUSblog reports,
    • The Supreme Court’s 2026-27 term will officially kick off on Monday [October 5]. The justices will hear argument that morning in two cases: Suncor Energy Inc. v. County Commissioners of Boulder County, on whether a lawsuit filed in Colorado state court seeking to hold energy companies responsible for their alleged role in climate change can go forward, or whether federal law instead bars such claims; and Johnson v. United States Congress, on whether a federal district court may hear a constitutional challenge to a law limiting disability benefits for certain incarcerated veterans.”
  • The Centers for Medicare and Medicaid Services announced last Thursday,
    • Medicare Improvement Fund Premium Rebate Frequently Asked Questions
    • Q: What will the Medicare Improvement Fund do for Medicare beneficiaries? 
    • A: The Administration is making a $90 Premium Rebate available for Part B premiums to certain Medicare beneficiaries because the best way to improve Medicare is to put healthcare dollars back where they belong – in the hands of our Medicare beneficiaries – and make coverage more affordable. 
    • Q: How much is the Medicare Improvement Fund Premium Rebate and when will beneficiaries receive it?
    • A: Eligible beneficiaries will receive one $90 rebate in October 2026. Most beneficiaries will receive a direct deposit for $90 on or around October 8th followed by an email or a letter from the President in mid-October. Some beneficiaries will receive a paper check for $90 from the U.S. Department of the Treasury later in October with the following accompanying message “Medicare Improvement Fund Payment; $90 Payment to Offset October Premium.” 
    • Q: Who will receive the Medicare Improvement Fund Premium Rebate?
    • A: The 20.8 million Americans in Original Medicare Part B who are: (1) Living in the United States, are (2) not receiving premium assistance from Medicaid; or, (3) not paying an Income-Related Monthly Adjustment Amount. Beneficiaries enrolled in Medicare Advantage are not eligible.
  • FEHBlog observation — While the FEHBlog is on Original Medicare Part B and lives in the U.S. he is ineligible for the rebate because he pays an IRMAA fee on top of his Part B premiums. It’s still a good deal.
  • The Wall Street Journal reports
    • “A new White House task force will have 120 days to report on the risks and opportunities of artificial intelligence—and determine the federal government’s responsibility—according to Jay Clayton, the director of national intelligence who effectively becomes the administration’s AI czar.
    • “The president asked that a group be put together that was going to ensure exactly what he said,” Clayton said, that “we stay the leaders in superintelligence, and that the interests of the American people are put first.” 
    • “Clayton will chair the “Super Intelligence Force” which takes President Trump’s preferred name for AI: super intelligence or SI.” * * *
    • “The task force will have three vice chairs: Emil Michael, undersecretary of war for Research and Engineering, who will be responsible for coordination with AI companies; Scott Kupor, director of the Office of Personnel Management, who will be responsible for coordination with critical infrastructure providers and other industry stakeholders; and Andrew Ferguson, chairman of the Federal Trade Commission, who will oversee consumer interests and groups advocating for people of faith, children, privacy, freedom of speech, freedom of expression, and freedom of association.
    • “Members of the task force will include Vice President JD Vance, Defense Secretary Pete Hegseth, Richard Walters, White House deputy chief of staff, Bessent, Wiles and others. External participants will include venture capitalists David Sacks, co-chair of the president’s Council of Advisors on Science and Technology and Condoleezza Rice, former Secretary of State in the George W. Bush administration, who will provide advice on national security.”

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

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

No Surprises Act News,

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

From the public health and medical research front,

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

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

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

Cybersecurity Saturday

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

From the frontier AI and Project Glasswing front,

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

From the cybersecurity policy and law enforcement front

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

From the cybersecurity breaches and vulnerabilities front

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

From the ransomware front,

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

From the cybersecurity business and defenses front,

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

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.”

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.”  

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Services news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), today announced that it has awarded $247.9 million in grants to expand access to addiction treatment, mental health services, and recovery support in communities across the country. The investments will strengthen mental health support in schools, expand trauma treatment for children and families, equip first responders and communities to reverse overdoses, and help people in recovery return to work and rebuild their lives.
    • “HHS is investing nearly $250 million to put lifesaving treatment and recovery services directly into communities across America,” said HHS Secretary Robert F. Kennedy, Jr. “Through President Trump’s Great American Recovery, we are expanding addiction treatment, preventing fatal overdoses, helping children and families heal from trauma, and giving Americans in recovery the support they need to rebuild their lives. We are equipping communities with proven tools that save lives and help people recover.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is launching an initiative with a founding group of 37 state partners to focus on how quality is measured in Medicaid and the Children’s Health Insurance Program (CHIP). The effort will put health outcomes — not processes and paperwork — at the center of how success is defined. CMS and its partners will prioritize measures that demonstrate meaningful improvements in prevention, chronic disease management, and behavioral health.
    • “For too long, Medicaid has measured whether boxes are checked instead of whether patients are getting healthier — that must change,” said CMS Administrator Dr. Mehmet Oz. “We should judge success by what matters — preventing disease, managing chronic conditions, and improving patients’ health.”
    • “We are shifting the focus from paperwork and process to real accountability for what matters: health outcomes. We are encouraged at this level of commitment from states, and we are ready to get to work with them to implement this vision,” said CMS Deputy Administrator Stephanie Carlton.”
  • Fierce Healthcare reports,
    • “A new coalition is bringing together employers, clinicians and other stakeholders to push for the expansion of direct contracting.
    • “The Association for Direct Care will advocate for policies that ease barriers to direct contracting arrangements between employers and providers, boost transparency and support new payment models. A key goal, according to the announcement, is to support lower costs and better quality as well as the relationship between providers and their patients.
    • “The organization will focus on the expansion of direct employer contracting in the commercial space as well as in federal health programs.”
  • Healthcare Dive relates,
    • “A new report from a conservative think tank is accusing 340B hospitals of providing less charity care than other nonprofit hospitals, despite receiving discounted drugs.
    • “Hospitals participating in the 340B drug discount program spent 2.16% of their operating expenses on free or discounted care for low-income patients, called charity care, compared with 2.82% at non-340B hospitals, according to a Thursday analysis from the Pioneer Institute and CancerCare.
    • “Hospitals pushed back on the report, with the American Hospital Association saying 340B hospitals provide support for patients in other ways. “This report is another in a long line of misleading studies that wrongly singles out charity care as the only way to measure how hospitals provide for their patients and communities,” Bharath Krishnamurthy, director of pharmaceutical policy at the AHA, said in an email.”
  • Per MedTech Dive,
    • “Diagnostics companies, under pressure from proposed Medicare reimbursement cuts, are renewing calls for Congress to pass legislation that could provide relief by changing how data for setting laboratory test payment rates is collected.
    • “A new clinical laboratory fee schedule proposed this week by the Centers for Medicare and Medicaid Services would usher in the cuts beginning next year. Lab service providers face payment reductions of 15% on 775 tests under the preliminary schedule for 2027, according to the American Clinical Laboratory Association. 
    • “Getting legislation through Congress that would avert the reductions will be a tough task, however. The House of Representatives is now in recess until after the November midterm elections.”

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

  • OPM Director Scott Kupor writes (Substack link) in his Secrets of OPM blog about his efforts to recruit young people into federal service.
    • “My message to students has been really simple – we don’t need you to make a 40-year decision to be a federal employee. Instead, give it a shot for 2-3 years and see if you like it. I hope some will and may re-up for another stint, but for sure many will decide to seek their calling elsewhere. That’s fine; we don’t need to fight that or denigrate that. Any public service is better than none and getting a firsthand understanding of how government works will engender a sense of patriotism that we can’t replicate in any better way.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Eli Lilly received FDA approval Sept. 24 for Onswik, a once-weekly basal insulin injection for adults with Type 2 diabetes.
    • “The FDA approved Onswik for use alongside diet and exercise to improve glycemic control. The drug delivers steady basal insulin levels over seven days. Lilly said the drug is designed to eliminate more than 300 injections per year compared with once-daily basal insulin.”
    • “Onswik is not indicated for Type 1 diabetes because it raises the risk of severe hypoglycemia in those patients.
    • “Lilly plans to launch the Onswik KwikPen in the U.S. in the coming months in two concentrations: 500 units/mL and 1,000 units/mL. The company did not disclose pricing.”
  • Fierce Pharma adds,
    • “In just over a month, the FDA has cleared not one, but two treatments for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic condition that causes soft tissues to turn to bone. 
    • “Regeneron’s Pasatru earned regulatory clearance in late August, and Friday, Mirum Pharmaceutical’s zilurgisertib, to be marketed as Atebrioz, joined the race. The FDA has grantedMirum’s once-daily oral medication a green light to treat FOP in patients ages 12 and up.  
    • “Atebrioz has fallen under Mirum’s purview thanks to a licensing deal between the rare disease pharma and Incyte in April. Under the deal, Mirum paid $16 million up front for global commercial rights to the drug, with additional regulatory and sales milestones potentially to follow.”

From the fraud, waste, and abuse front,

  • Govexec reports,
    • “The Trump administration claims it found more than $1.2 billion in suspected fraud and stopped $41 million more across five COVID-related contracts, according to a Wednesday press release from the General Services Administration.
    • “GSA said although the COVID-19 national emergency and related acquisition flexibilities were cancelled in 2023, unnamed federal contractors continued to receive funding. The alleged fraud was uncovered in collaboration with the Health and Human Services Department and under the direction of the White House Task Force to Eliminate Fraud.
    • “The COVID emergency ended over three years ago, yet fraudsters continue to weaponize outdated emergency contracts to abuse taxpayer dollars,” GSA Administrator Edward Forst said in the release. “GSA will continue to work with the Vice President’s task force to stop improper payments, refer suspected fraud to law enforcement, and fight to recover every dollar.”
    • “GSA estimates that about 93% of the contract funding — which would have been distributed for COVID vaccines and other pandemic-related services — has not yet been distributed to vendors, while roughly 6.78% has already been expended, according to a Fox News exclusive attached to the release. The agency has suspended payments to contractors, although the uncovered funding is not currently tied to criminal charges for contractors, the outlet reported.”

From the judicial front,

  • The Hill reports,
    • “The U.S. Court of Appeals for the D.C. Circuit sided with the Trump administration in its blacklisting of the artificial intelligence firm Anthropic, allowing the Pentagon to label the AI firm a supply chain risk. 
    • “The 2-1 ruling, issued Friday [DC Circuit link], rejected Anthropic’s challenge of the designation, finding the Department of Defense had “ample support” for its belief that the continued use of Anthropic’s Claude models by the agency or its contractors presented a national security risk.” * * *
    • “Friday’s ruling breaks with a California federal judge’s decision last month finding the government violated the First Amendment when it issued the supply chain risk.” * * *
    • “A spokesperson for Anthropic said the firm “respectfully disagrees” with the appeals court ruling.
    • “Another federal court has already held the government’s parallel designation unlawful,” they added. “We remain confident in our position and are considering all options, including further review.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 25, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
      • “COVID-19 activity remains elevated but is declining nationally. COVID-19 hospitalizations remain low.
      • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
      • “RSV activity is very low.
      • “Seasonal flu activity is low.”
  • The University of Minnesota CIDRAP reports,
    • “The US measles count has climbed to 3,659 confirmed cases, with 171 new cases added this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “Of the 3,659 confirmed cases, 18% are in children age 5 and under, 43% in children and teens aged 5 to 19, and 38% are in adults 20 and older. Nine percent of case-patients have been hospitalized. Ninety-five percent of case-patients are unvaccinated or have unknown vaccination status.” * * *
    • “Pennsylvania remains the nation’s hot spot, with 129 new cases in the past seven days and 890 for the year, according to an update today from the Pennsylvania Department of Health. Lancaster County, where two of the state’s measles deaths have been reported, has been the hardest hit, with 342 cases. 
    • “Other states with notable increases in measles cases include Ohio, which added nine new cases this week and now has 189 for the year; Kentucky, which added 10 new cases and has 67 for the year; and Wisconsin, which added four new cases and has 171.”
  • and
    • “The bivalent (two-strain) respiratory syncytial virus (RSV) vaccine made by Pfizer (RSVpreF, or Abrysvo) reduced the risk of hospitalization and emergency department (ED) visits for at least three seasons after vaccination in older adults with a high prevalence of comorbidities, according to a study published last week in Infectious Diseases and Therapy. 
    • “A separate study published the same day in JAMA Network Openfound that RSV vaccines provided substantial protection against RSV-related hospitalization and death among adults aged 65 and older and people with weakened immune systems during the 2023-24 respiratory virus season. 
    • “RSV is a leading cause of lower respiratory tract disease (LRTD) with severe outcomes, particularly among older adults and those with compromised immune systems. The Centers for Disease Control and Prevention estimates that RSV contributes to around 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths among older adults in the United States each year.” 
  • Beckers Clinical Leadership relates,
    • “The death rate tied to three common, treatable emergency surgical conditions increased about 50% between 1999 and 2020, according to an abstract being presented at the American College of Surgeons Clinical Congress 2026 in Washington, D.C., Sept. 26-29.
    • “Researchers at Peoria, Ill.-based OSF HealthCare analyzed nearly 20,000 deaths from the CDC WONDER Multiple Cause of Death database to assess mortality trends tied to emergency general surgery conditions.”
    • “The conditions included in the study were appendicitis, acute cholecystitis and abdominal wall hernia with obstruction or gangrene, recorded as a contributing factor to — not necessarily the main cause of — death.” * * *
    • “The study “raises important questions about whether patients are getting to surgical care in time, especially in rural communities, and whether workforce shortages or other pressures are contributing,” Vishnu Mani, MD, the study’s lead author and emergency general surgery medical director at OSF HealthCare, said in a Sept. 25 news release.”
  • Beckers ASC Review tells us,
    • “Patients who had an appendectomy for acute appendicitis had a 58% lower relative risk of a later colorectal cancer diagnosis than similar patients treated with antibiotics alone, according to new research set to be presented at the American College of Surgeons Clinical Congress 2026 in Washington, Sept. 26-29.” * * *
    • “The management of acute appendicitis has changed significantly over the last decade, and antibiotic therapy is now an accepted option,” Valentine Nfonsam, MD, the study’s senior author and professor and executive vice chair of the department of surgery at Morehouse School of Medicine, said in the release. “We wanted to ask a different question: Are there potential long-term oncologic implications of leaving the appendix in place after appendicitis?”
    • “The exact mechanism behind the association is unclear, but researchers said it could involve earlier detection of an underlying malignancy, removal of a source of inflammation, or the appendix’s role in the gut microbiome and immune system. Dr. Nfonsam cautioned that the findings shouldn’t be read as a reason for every appendicitis patient to undergo surgery, and said age, genetic predisposition, family history and other colorectal cancer risk factors should still guide patient selection and follow-up. The findings are being presented as a research abstract and have not yet been peer-reviewed.”
  • Cardiovascular Business informs us,
    • “For-profit hospitals in the United States may be starting to fall behind their nonprofit counterparts when it comes to heart attack outcomes, according to new data published in JACC: Advances.[1] Readmission rates—a recognized sign of care quality—seem to be falling at nonprofit hospitals while they remain mostly unchanged at for-profit facilities.
    • “The study’s authors reviewed data from more than 4.6 million acute myocardial infarction (AMI) hospital admissions from 2013 to 2022. All data came from the Agency for Healthcare Research and Quality’s Nationwide Readmissions Database. ST-segment elevation myocardial infarction (STEMI) and non-STEMI diagnosis codes were used to identify AMI hospitalizations. 
    • “Overall, the AMI readmission rate at for-profit hospitals remained relatively stable from 2013 (13%) to 2022 (12.7%). At nonprofit hospitals, on the other hand, the AMI readmission rate dropped from 11.5% in 2013 to 10.5% in 2022. This same pattern was true when only looking at patients undergoing percutaneous coronary intervention (PCI) procedures. For patients undergoing coronary artery bypass grafting (CABG), meanwhile, both for-profit and nonprofit hospitals saw readmission rates decline over the course of the study.
    • “The authors also found that for-profit and nonprofit hospitals were linked to comparable in-hospital mortality rates. One area where for-profit hospitals bested nonprofit hospitals was reducing cardiac complications. Respiratory and renal complications, on the other hand, were more common at for-profit hospitals than they were at nonprofit hospitals.”
  • Healio adds,
    • “The stroke incidence rate among young adults nearly doubled from 1993 to 2020 while decreasing among older adults, according to research published in Neurology.
    • “Over that same time, researchers saw an increase in the percentage of patients with stroke who had substance use as well as conditions associated with vascular risk, such as hypertension, diabetes and atrial fibrillation, said Emily R. Fisher, MD, a neurology resident and fellow at the University of Cincinnati.
    • “Our findings highlight the importance of regular primary care, even for younger adults without chronic medical conditions,” Fisher told Healio. “Routine medical care and recommended screenings are very important to detect stroke risk factors and to address them appropriately, as one may not have symptoms from these conditions.”
  • and
    • “The risk for egg or peanut allergy in 1-year-olds was not lower among women who ate high vs. standard amounts of eggs and peanuts during pregnancy and lactation, according to data published in The New England Journal of Medicine.
    • “Based on these new large-scale trial results, clinicians can reassure pregnant women that they do not need to eat high amounts of common food allergy causing foods (such as eggs and peanuts) to reduce the risk of their baby developing these food allergies,” Debra J. Palmer, PhD, associate professor and head of nutrition in early life at The Kids Research Institute Australia, told Healio.”
  • Nature notes,
    • “Most people taking the popular GLP-1 drugs shed substantial amounts of weight — an average of one-quarter of their body weight according to one study1. So why do 10–15% of people using the drugs lose minimal weight or none at all?
    • “There is tremendous heterogeneity” in the response to these medications, says Daniel Drucker, an endocrinologist at the University of Toronto in Canada, whose work aided in the development of GLP-1 drugs. “And we really don’t understand that.”
    • “Solving this mystery might lead to new medications for people who do not benefit from today’s versions of such drugs and could make it possible to match individuals to treatments that are most likely to work for them. Those tantalizing possibilities have made people’s individualized responses to GLP-1s a key line of enquiry for obesity scientists. The Endocrine Society, a leading medical and research organization in Washington DC, has already called for it to be a priority for the field, with scientists looking into various explanations, including biological sex, genetics and behavioural factors.
    • “For now, research to identify the differences between those who do or don’t respond to the drugs is in its early days, and precision medicine for obesity remains “largely aspirational”, according to a scientific statement published by the Endocrine Society earlier this month. But researchers are starting to dig into these questions with energy.”

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

  • Per Tech Target,
    • “Employers can expect to pay 9.5% more for employee health benefits in 2027, with new reporting from professional services firm Aon projecting average employee healthcare costs totaling more than $19,000 in the coming year.
    • “These numbers reflect the fourth consecutive year of healthcare cost growth approaching double digits, the firm said.
    • “At this level, rising health care costs become much more than a budgeting challenge and influence organizational decisions from benefits strategy and employee affordability to broader workforce and financial planning priorities,” Mike Pasterick, North America Health Solutions leader at Aon, said in a statement. “Leaders are undergoing pressure to maintain affordable benefits while continuing to invest in attracting, supporting and retaining talent.”
    • “The drivers behind these healthcare cost increases might not be surprising. According to Aon, trends like increased healthcare utilization, greater chronic disease prevalence and the volume of high-cost claims all contribute to rising health benefits costs.”
  • Modern Healthcare reports,
    • “Penn Medicine, Independence Blue Cross and Regent Surgical are forming a company and plan to build and operate at least 18 ambulatory surgery centers. 
    • “The facilities will be located in Penn Medicine’s service area of Pennsyvania, New Jersey and Delaware. The first one is expected to open next year, a spokesperson said Friday. A timeline for when all facilities will be complete has not been announced.
    • “The venture will be structured as a for-profit company. Additional details were still being finalized, a spokesperson said. Regulatory approvals, market conditions and community needs will factor into the decisions.”
  • and
    • “Rightway, an upstart pharmacy benefit manager covering about 3 million people, is considering an initial public offering in the years ahead as it tries to chip away at a market long dominated by some of the largest healthcare conglomerates in the U.S.
    • “The closely held company was valued at $1.75 billion after it closed a recent fundraising round, according to a person familiar with the matter who wasn’t authorized to speak publicly.
    • “The public markets are where some of the best companies in the world are built,” Chief Executive Officer Jordan Feldman said in an interview. Rightway, which is profitable, is weighing a public market debut in the next four years, he said. “That public currency and transparency are certainly something that we strive toward.” * * *
    • “Rightway’s only revenue stream is a per-enrollee fee that is not related to the price of the drug, Feldman said. That leads to savings for clients on their overall drug expenses and slower spending growth, he said.”
  • The Wall Street Journal relates,
    • “Novo Nordisk agreed to pay up to $1.3 billion to license and develop Swedish pharmaceutical company Nanexa’s drug delivery technology in a deal that could cut the frequency that patients need to inject its obesity and diabetes drugs.
    • “The deal covers Nanexa’s PharmaShell technology, which is designed to enable controlled and sustained release of active pharmaceutical ingredients through an ultra-thin coating applied to individual drug particles.
    • “Under the exclusive deal announced late Thursday, Novo has licensed Nanexa’s technology in up to five development programs covering different drug administration frequencies, with the companies targeting monthly and quarterly administration.
    • “Novo will lead global development and commercialization, with Nanexa eligible to receive upfront consideration and potential milestone payments totaling up to 1.17 billion euros ($1.33 billion).
    • “The Danish drugmaker will pay 615 million euros in upfront and development and regulatory milestone payments, in addition to royalties on future product sales.”
  • Per BioPharma Dive,
    • “RNA drugmaker ADARx Pharmaceuticals on Thursday priced its $446.3 million initial public offering and received an additional boost with a separate investment from development partner AbbVie. 
    • “The biotechnology firm sold more than 26 million shares at $17 apiece, at the top end of the $15-$17 price point it originally laid out in federal filings. It also secured about $89 million through a private stock sale to AbbVie. ADARx begins trading on Nasdaq on Friday under the ticker symbol “ADRX.” 
    • “ADARx is one of a handful of companies specializing in what’s called RNA interference, a form of drugmaking that involves stopping the body from producing problematic proteins. Biotechs like Alnylam Pharmaceuticals and Arrowhead Pharmaceuticals have successfully brought RNAi drugs to market.”
  • Beckers Behavioral Health lets us know,
    • “OpenAI released MentalHealthBench, an open benchmark that measures how AI systems respond in realistic mental health conversations, on Sept. 23.
    • “The company built the benchmark with more than 80 licensed psychologists and psychiatrists from 22 countries. The cohort speaks 19 languages and represents nearly 20 mental health subspecialties. The benchmark scores model behaviors including safety, context-seeking, preservation of user agency and actionable guidance.” * * *
    • “OpenAI, whose ChatGPT reaches more than 1 billion people each week, released the benchmark openly so outside researchers can examine its methods and run their own evaluations.”
  • Per Radiology Business,
    • “Despite the increasingly unpredictable landscape of the healthcare sector, radiologists’ total cash compensation has remained steady, with some of the specialists enjoying an 18% increase in pay since 2024. 
    • “That’s according to new data from SullivanCotter’s 2026 Physician Compensation and Productivity Survey. The consulting firm’s annual survey includes data from 575 healthcare organizations representing approximately 235,000 physicians across 240 specialties. It contains detailed information organizations can use to help them navigate rising physician pay expectations, recruitment pressures and the changing metrics that define productivity. 
    • “According to the data, median total cash compensation increased year over year in 2026 across all major physician specialty categories. Adult medical specialties posted the largest gain, rising 7.2% from 2025 and 25.2% over the past five years.”  
  • Beckers Physicians Leadership tells us,
    • “Sixty-three percent of OB-GYNs and 63% of general surgeons have been named in a malpractice lawsuit, according to a new report from Medscape.
    • “Across all specialties, 33% of physicians said they had been a sole defendant, a co-defendant or both in a malpractice suit. That included 34% of specialists and 31% of primary care physicians.
    • “Medscape’s “Physicians and Malpractice Report 2026,” published Sept. 22, collected data from more than 1,100 full- and part-time physicians across nearly 30 specialties.”
  • Beckers ASC News informs us,
    • “The U.S. is projected to face a shortage of 27,940 surgeons by 2038, and vascular surgery is expected to be hit hardest, according to a study from the American College of Surgeons.
    • “The researchers called it the first unified assessment of the country’s surgical workforce. They used the Health Workforce Simulation Model from HHS to project supply and demand across 10 surgical specialties from 2023 to 2038, according to a Sept. 25 news release from the ACS.
    • “Nationally, surgeon supply is projected to fall 4.2% over the period while demand grows 12.8%. That would leave the workforce meeting 84.3% of need, with larger gaps in rural areas.”
  • Fierce Pharma notes,
    • “Total prescriptions for both Eli Lilly’s Foundayo and Novo’s Wegovy pill have bounced back following a holiday dip and reached new records. Weekly scripts for the Wegov pill jumped 14% sequentially to about 184K, compared with its previous high of 183K, according to IQVIA data cited by Citi. Foundayo climbed 13% to cross 50K for the first time, reaching 53,321.
    • “Foundayo now captures about 1 out of 3 new starts for oral GLP-1 obesity drugs, and “that’s growing week over week,” Lilly CEO David Ricks told CNBC in an interview this week. 
    • “As Leerink Partners analysts noted in a Sept. 23 note, effective Sept. 1, Lilly cut the initial-dose pricing for Foundayo 0.8 mg, 2.5 mg and 5.5 mg to $149, $149 and $199 per month for self-pay patients, respectively. The company framed the promotion as an elasticity experiment and as a push to the first maintenance dose, according to the Leerink note.
    • “As Jefferies analysts pointed out in a Sept. 25 note, the majority of Foundayo scripts seem to be cash pay, with about 80% of patients still on starting doses.”

Thursday report

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

Simplicity is a virtue.

From Washington, D.C.

  • STAT News reports,
    • “Congress is considering the first major overhaul of how Medicare pays doctors in more than a decade, and both Democrats and Republicans appear to agree on the outlines of an approach.
    • “The main policy under consideration would link Medicare’s doctor pay rates to a medical inflation measure, giving doctors guaranteed pay boosts, as hospitals and other parts of the health care system have long received.  
    • “In doing so, Congress would be retreating from the notion that Medicare can control how many services physicians provide on a national basis, an idea that has undergirded Medicare’s doctor payments for decades. And it would reduce the government’s push to get clinicians to engage in value-based care, where they get paid more to keep patients healthy.” * * *
    • “The measure under consideration is called the Patients First Act, and would establish a permanent, annual payment hike linked to the Medicare Economic Index (MEI), minus 1%. 
    • “During a recent House committee hearing, Republicans and Democrats praised the Patients First Act. No one in either party spoke against it. Congressional Medicare advisers also recommended the MEI minus 1% formula.
    • “Following the hearing, Energy and Commerce health subcommittee Chair Morgan Griffith (R-Va.) predicted that Congress would pass some of the doctor pay measures, but he cautioned about the need for “tweaks” due to their cost.
    • “Some of them may need a few tweaks, but I don’t think we would’ve done this today if we weren’t at least going to try to get some of them across the finish line during lame duck,” Griffith said.”
  • Fierce Healthcare relates,
    • “The Senate Finance Committee has advanced the nominees for two key Department of Health and Human Services posts.
    • “The committee members voted 15 to 12 to advance the nomination of Chris Klomp to serve as Deputy HHS Secretary and 14 to 13 to advance the nomination of Ge Bai, Ph.D., as Assistant Secretary for Planning & Evaluation (ASPE) at the agency. The nominees had addressed the committee on Sept. 15 alongside nominees for positions at the Internal Revenue Service and U.S. Tax Court.
    • “Klomp is a rising star at HHS and currently leads the Department of Medicare at the agency. If his nomination is approved, he would become second-in-command at the department, a position that has been vacant since Jim O’Neill departed in February.”
  • and
    • “The Senate Committee on Health, Education, Labor and Pensions (HELP) today questioned Heidi Overton, M.D., Ph.D., the president’s pick for FDA commissioner, in a hearing marked by tightrope-walking on issues like vaccines, abortions, flavored vapes and whether or not Donald Trump is capable of being wrong. 
    • “Overton conceded multiple times during the hearing that vaccines approved by the FDA, as well as the so-called “abortion pill” mifepristone, are safe and effective. But she stopped short of admitting that Trump has been wrong when dispensing medical information out of line with what the scientific evidence shows. 
    • “The committee will next vote on whether to send Overton’s nomination to the full senate for approval.” 
  • Healthcare Dive tells us,
    • “CMS Administrator Dr. Mehmet Oz delivered a candid assessment of artificial intelligence’s impact on healthcare costs Wednesday: It’s going to get worse before it gets better.
    • “Short term, AI is going to be inflationary because it’s going to turbocharge the ability of the current billing systems to work more effectively,” Oz said at Oracle’s annual health and life sciences summit in Orlando. 
    • “It’s the latest signal from the industry that AI could be inflating healthcare costs — even as its proponents argue the technology will lower them over time.” * * *
    • “For providers, AI-powered coding is enabling them to bill insurers for more conditions when they treat patients. They say the technology helps them more accurately bill for care, while insurers say doctors are using AI to charge more money without any actual increase in medical care.
    • “A study released by the insurer group Blue Cross Blue Shield Association on Thursday found that the increase of billing has added nearly $1 billion in healthcare costs between 2023 and 2025. The group said the study “raises concerns” that AI tools are contributing to higher spending.” * * *
    • “Although Oz noted the increase in healthcare costs, he said AI was still essential in the industry.
    • “I guarantee you we will lose lives if we don’t use AI in the day-to-day trench warfare of fighting disease in America,” he said.
    • “Oz said he hoped AI would lower healthcare costs in the long run, and that the government was relying on one particular area to make that happen: accountable care organizations.”

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

  • Following up on yesterday’s post about FedSmith’s helpful breakdown of the FEHB / PSHB questions for which OPM has requested public comment, it turns out that the public already has submitted 113 comments to the agency. You can access those comments here. In contrast to OPM’s limited posting of comments on its modified system of records notice, OPM has posted all 113 comments received to data on this new topic.
  • Tammy Flanagan, writing in Govexec, tells us,
    • “What changed in your federal benefits in 2026 — and what could change next? Agencies updated federal retirement, insurance, Social Security and Thrift Savings Plan programs, while Congress considered proposals affecting future pay and benefits. This article summarizes the changes that took place in 2026 along with the links to official sources.
    • “Review the 2026 changes now and watch for 2027 updates this fall. During Federal Benefits Open Season, OPM will soon begin to publish 2027 plans, premiums and coverage information. The September CPI release on Oct. 14, 2026, will provide the final CPI-W data used to determine 2027 Social Security and federal retirement COLAs.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “With some trepidation, a majority of an FDA advisory committee Thursday endorsed the Galleri multicancer early detection blood test.
    • “By 6-4 and 7-2 (with one abstention) margins, the molecular and clinical genetics panel of the Medical Services Advisory Committee voted that the test was effective and that its benefits outweigh the risks. However, many panel members who voted yes had reservations about their votes.
    • “The panel was more decisive on the question of safety, voting unanimously (10-0) in favor of Galleri.
    • “While most panel members agreed that as a diagnostic test Galleri was safe, effective, and demonstrated a positive benefit/risk profile, particularly for cancers for which screening tests are unavailable, they were concerned about the lack of outcome data supporting the test’s premarket approval (PMA) application, as well as the use of the term “early” in describing the purpose of the test.
    • “I really struggled with this one … I did change my vote twice,” said Jason Dominitz, MD, MHS, of the VA Puget Sound Health Care System in Seattle, explaining his yes vote on Galleri’s effectiveness. “Clearly, there are clinically impactful results of the test. People get a diagnosis work-up, cancers are found, but does that lead to clinically clinical benefit? I don’t see that we have evidence of clinical benefit at this time.”
    • “The question comes down to what do you call clinical effectiveness,” said Stanley Lipkowitz, MD, PhD, of the National Cancer Institute, who voted no. “As an oncologist, I generally look at that as outcome, and we don’t have that data.” * * *
    • “While not bound by its advisors’ recommendations, the FDA usually follows their advice.”
  • USA Today relates,
    • “Officials have classified the risk level of a thyroid medicine recall initiated last month to its most serious category.
    • “On Sept. 22, the U.S. Food and Drug Administration categorized the recall – which applies to one lot of thyroid tablets sold by Vitruvias Therapeutics Inc. – as a Class I recall, its highest risk level.
    • “Last month, Vitruvias Therapeutics Inc. recalled one lot of its 30 mg thyroid tablets because they could be superpotent, or stronger than intended, according to a FDA recall notice published on Aug. 24.
    • “The affected products include thousands of units distributed nationwide from January to September 2025 with an expiration date in September 2026, according to the notice.
    • “A Class I recall – the most serious FDA category – indicates that using the product is likely to cause serious health effects or death, according to the agency.”
  • CBS News considers “whether an FDA crackdown [noted in yesterday’s FEHBlog will] curb access to cheaper GLP-1 weight-loss drugs?
    • Scott Brunner, CEO of Alliance for Pharmacy Compounding, said that the FDA’s warning wasn’t about the volume alone, but the lack of documentation to prove that Empower was appropriately making the drug for individual patient needs.
    • “The FDA is possibly marking a line in the sand,” said Darshan Kulkarni, founding partner of the Kulkarni Law Firm and an expert in healthcare and pharmacy law. For now, though, the FDA’s warning shot is more likely to prompt compounding pharmacies to reframe how they differentiate their weight-loss products than to immediately stop making them, he said.
    • “But with the FDA taking a stance on the limits of compounded weight-loss drugs, he said, “That avenue is definitely getting narrower.”

From the public health and medical / Rx research front

  • Beckers Hospital Review reports,
    • “A recent study found 11.3% of healthcare personnel surveyed reported persistent long COVID symptoms.
    • “The study, published in the American Journal of Industrial Medicine, used electronic surveys to collect symptom data at three and six months post-infection from 1,496 healthcare personnel. Long COVID was defined as the same moderate or severe symptom reported at both time points. 
    • “Here are the findings.
      • “1. Older age was associated with higher odds of persistent symptoms, and female healthcare personnel had greater odds of persistent symptoms than male personnel. 
      • “2. Prior COVID infection or more than two underlying health conditions were also associated with higher odds of long COVID.
      • “3. Physicians, licensed practical and registered nurses, and therapists or therapy assistants had lower odds of long COVID than nonclinical healthcare personnel.”
  • MedPage Today tells us,
    • Lyme disease is the nation’s most frequently reported vector-borne disease.
    • In a U.S. cohort study, 29.5% of people positive for the bacteria that causes Lyme disease also tested positive for at least one of three other tick-borne pathogens.
    • The study suggests that even with typical Lyme disease symptoms, clinicians should consider the presence of other tick-borne pathogens, which may have implications for treatment.
  • and
    • “Residual lifetime ovarian cancer risk warrants consideration of risk-reducing bilateral salpingo-oophorectomy for healthy older BRCA carriers.
    • “Individualized decision-making about surgery should weigh risk reduction against impact on fertility and quality of life.
    • “Substantial residual risk remains for women who delay surgery to age 50, particularly for BRCA1 carriers.”
  • Health Day adds,
    • “Glucose patterns captured by continuous glucose monitors (CGMs) are linked to cardiometabolic risk in adults without diabetes, according to a study published online Sept. 17 in Diabetes Care.”
  • The American Medical Association lets us know “what doctors want patients to know about high cholesterol.” 
    • “Sorting through the good, the bad and the ugly about high cholesterol can be confusing. Understanding your overall risk, and not just one number, can help.”
  • Cardiovascular Business considers “Semaglutide is improving the heart health of millions—but how? Experts are stumped.”
    • “Professor Helen Colhoun, MBBChBAO, MD, a healthcare researcher and diabetes specialist with the University of Edinburgh, et al. tracked differences related to body weight, waist circumference, lipids, blood pressure and more in patients given semaglutide and those given a placebo. The overall conclusion was improvements in weight loss and waist circumference only partially explain the cardiovascular benefits being seen among patients given semaglutide. There is something more going on there—but what that happens to be is not yet totally clear.
    • “Our analyses could not fully ascribe the effects of semaglutide on cardiovascular disease to known risk factors with any certainty,” Calhoun said. “Whether we combine all risk factors together or look at some subsets of the risk factors, no more than half of the reduction in heart disease could be explained by the changes in these risk factors. These results suggest that semaglutide should be considered as a cardiovascular disease reduction drug and not just as a weight loss drug.” 
    • “She added that more research is still needed to help clinicians learn more about this significant trend. 
    • “Click here to read the full analysis.”
  • Reuters points out,
    • “Scientists have created a detailed map of gene activity within a crucial part of the brain called the prefrontal cortex, gaining insight into normal development and major brain disorders such as Alzheimer’s disease, Parkinson’s disease and ​schizophrenia.
    • “In nine separate studies, the researchers examined changes in individual types of brain cells that occur over time and made progress toward deciphering molecular processes ‌that underlie some of the most devastating brain disorders, a step toward possible new treatments.
    • “The prefrontal cortex is the front part of the brain’s outer layer, located behind the forehead. It helps a person plan, make decisions, regulate emotions and adapt behavior. It also is sensitive to age-related decline, and its functions are affected in many psychiatric and neurodegenerative disorders.” * * *
    • “The research identified patterns shared across some of the diseases as well as some ​specific to individual disorders.
    • “Together, these studies help explain where disease-related changes occur and which biological processes deserve closer investigation,” said Dr. Panos Roussos, director of the Center for Disease Neurogenomics at ​the Icahn School of Medicine at Mount Sinai in New York City and a leader of the research published on Wednesday in Nature, opens new tab and other journals.
    • “A useful treatment needs to influence the right biological process in the right cells. This map helps narrow that search. It can identify vulnerable cell populations, reveal processes associated with preserved brain function and help researchers decide which potential treatment targets to test,” Roussos ​said.”

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

  • Beckers Payer Issues reports,
    • “The Cigna Group is partnering with OpenAI to integrate AI into clinical workflows, with a first focus on cancer care.
    • “Under the collaboration announced Sept. 23, OpenAI’s tools will be built into workflows across Accredo Specialty Pharmacy and the insurance business, Cigna Healthcare. The first new capability will give oncology nurses and case managers an AI-enabled view that pulls together clinical, pharmacy, behavioral and benefits information for each member.
    • ‘The companies said the goal is to identify member needs earlier and personalize support between physician visits, when patients are often dealing with side effects, new symptoms and unanswered questions. The system is designed to feed insights from member responses back into future guidance and workflows over time.”
  • Cotiviti adds,
    • “Cotiviti and MedCity News just published the 2026 Healthcare AI Readiness Index revealing fascinating insights, including a striking contradiction.
    • “AI adoption is essentially universal in healthcare. Investment in AI is accelerating, and executives clearly see operational value. Yet only a minority feel prepared for AI-enabled cyberthreats. Less than 40% have detailed governance policies, more than 60% of respondents report shadow AI usage, and most still require human oversight for the highest-consequence decisions.
    • “Healthcare doesn’t have an AI adoption challenge. It has an AI readiness challenge. Governance, cybersecurity, and human oversight are all evidence of the broader gap between AI adoption and readiness. This gap may be the most important risk that healthcare executives aren’t measuring.”
  • Healthcare Dive points out,
    • “Investment in health IT is a top priority for a majority of providers and payers, though executives are seeking solutions for specific use cases that provide measurable results, a new survey from Bain & Company and KLAS Research shows.
    • “Tools that target revenue cycle management, patient engagement and clinical workflows are attracting attention — and investment dollars — from providers. Payers are focused on utilization management, care navigation and claims processing.
    • ‘Executives are especially emphasizing measurable return on investment when it comes to AI, with some seeking returns of 3x to 3.9x their original investment, according to the survey.”
  • Fierce Healthcare relates,
    • “UnitedHealth Group has named Jodee Kozlak to the newly created role of chief administrative officer, the healthcare giant announced Thursday morning.
    • “Kozlak will take the position on Sept. 28, per the announcement. In this role, she will be tasked with leading the company’s enterprise modernization efforts, including a portfolio that will initially include people, real estate, procurement and corporate security.
    • “Kozlak is currently chair of the board at C.H. Robinson Worldwide, a transportation and third-party logistics company, and is lead independent director for KB Home, a homebuilding company. She served as the global senior vice president for the Alibaba Group from 2016 to 2017, supporting the company’s expansion outside of China.
    • “She also held multiple leadership roles at Target Corporation between 2004 and 2015, including in human resources and legal, UnitedHealth said in the announcement.”
  • Beckers ASC Review informs us,
    • “Private equity ownership has become increasingly common across physician practices over the last decade, with investors backing groups in specialties like anesthesiology, orthopedics, gastroenterology and pain management. 
    • “Now, a new federal bill aims to ban it outright.
    • “Democratic lawmakers introduced the Stop Corporate Takeovers of Physicians Act on Sept. 16. The federal bill would ban private equity firms, insurers and other for-profit corporations from owning or controlling physician practices.
    • “Becker’s connected with 14 physicians, healthcare executives and attorneys to get their take on the bill. Most agreed the legislation is unlikely to pass or to fully undo private equity’s footprint in healthcare, but several said it targets the right problem and could shape future deals. Many also warned that the bill’s exemptions for hospitals and nonprofits could speed up hospital consolidation, and that it does little to address the reimbursement pressures pushing independent practices toward outside investors in the first place.”
  • Cardiovascular Business notes,
    • “The Heart Failure Society of America (HFSA) has released a new comprehensive look at heart failure (HF) clinics in the United States. The report includes more than 300 HF programs located in 47 states that serve approximately 626,000 patients.
    • “HFSA wanted to shine a spotlight on the country’s specialty clinics, often found in academic medical centers, while highlighting care gaps where many patients remain underserved. For instance, many Southern and Appalachian states—areas known for especially high risks of HF and other cardiovascular conditions—still have fewer clinics than are needed to ensure patients can easily access high-quality care.
    • “This report shows where specialty heart failure care exists in the United States and, just as importantly, where it doesn’t,” HFSA President Kenneth B. Margulies, MD, said in a statement. “The clinics in this database represent professional, multidisciplinary care. But the mismatch between where that care is concentrated and where the disease burden is heaviest is the central challenge our country needs to address.” * * *
    • “Click here for the full report. Its release comes just days before ASM 2026, HFSA’s annual scientific meeting.”