Friday report

Congress

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.” 

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, HSA, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

  • Govexec reports,
    • “More than 100 members of Congress urged House and Senate leaders last week to advance legislation rejecting President Trump’s planned pay freeze for most civilian federal workers next year.
    • “Last month, Trump issued his alternative pay plan, which formally confirmed the White House’s proposal to freeze most civilian workers’ pay at 2026 levels. Trump separately instructed the Office of Personnel Management to prepare to issue a 3.8% raise to federal law enforcement officers, and he has proposed pay increases between 5% and 7% for military service members, depending on their rank.
    • “In a letter to House Speaker Mike Johnson, Minority Leader Hakeem Jeffries, Senate Majority Leader John Thune and Minority Leader Chuck Schumer, sent last week but published Monday, a bipartisan group of 110 lawmakers led by Rep. James Walkishaw, D-Va., and Sen. Chris Van Hollen, D-Md., warned that with inflation hovering over 3%, forcing federal workers to forgo a pay raise is “an effective pay cut.”
    • “The administration’s own proposal on federal pay increases demonstrates why such an increase is necessary,” they wrote. “President Trump has proposed that federal law enforcement personnel receive a 3.8% pay increase to improve recruitment and retention, and has proposed a 5-7% pay increase for service members given the critical support they provide our nation. The same rationale applies to all federal workers.”
  • MedPage Today informs us,
    • “A proposal from CMS to cut in half the payment for secondary services performed during outpatient visits is drawing fire from a variety of healthcare groups.
    • “The damage would be extensive to practices who offer procedures and E/M [evaluation and management] visits on the same day as it impacts many clinical scenarios (dermatology, otolaryngology, ophthalmology, and many more),” Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association (MGMA), said in an email to MedPage Today. “MGMA members have relayed to us significant projected financial losses if this cut would go into effect.”
    • “Under the proposed rule, known as the “modifier 25 rule,” if two or more services are performed on the same day, “the most expensive service (either surgical or E/M visit) would be paid at 100%, and all other surgical procedure(s) or E/M visit(s) would be paid at 50%,” CMS explained in a July 16 Federal Register noticeopens in a new tab or window.
    • “For example, suppose a patient goes to the doctor for an outpatient E/M visit, which is billed using CPT code 99212, and then has two skin lesions removed, one billed under CPT code 11300, and the other — a slightly bigger lesion — billed under CPT code 11301. Because the second skin lesion removal code is the highest-paid service of the three, that code will get paid at 100%, while payments for the office visit and removal of the smaller skin lesion will be reduced by 50%.
    • “We continue to believe that there are efficiencies when the same physician (or a physician in the same group practice) provides an E/M service for the same patient in conjunction with a procedure with a global period, and that we are likely duplicating payment under the current payment methodology,” the authors wrote in explaining the proposal, which was originally proffered in 2019 but later withdrawn.” * * *
    • “The comment period on the proposal, which is part of a larger rule on physician payment and other issues, ended Monday. The agency has until Nov. 1 to issue a final rule; it could include the modifier 25 proposal as-is, make changes to it, or leave it out entirely.”
  • Fierce Healthcare points out,
    • “The American Medical Association (AMA) is urging the U.S. Centers for Medicaid and Medicaid Services (CMS) to uphold its Jan. 1, 2027 deadline for electronic prior authorizations under its Interoperability and Prior Authorization final rule.
    • “In a Sept. 18 letter (PDF) to CMS Administrator Mehmet Oz, M.D., AMA President John Whyte, M.D., wrote the agency should maintain its deadline and “reject broad enforcement discretion during 2027.”
    • “CMS should stay the course and remain steadfast in its commitment to ‘axe the fax’ and make [electronic prior authorization (ePA)] a reality for physicians and patients,” Whyte wrote.”
  • The American Hospital Association News relates,
    • “The White House issued a presidential proclamation Sept. 18 renewing the $100,000 fee for new H-1B visa petitions for individuals entering the U.S., initially levied in September 2025. The fee, currently blocked by a court order, was vacated by a district court in June and is pending appeal. The AHA had asked the administration last year to make healthcare personnel exempt from the fee. The Sept. 18 proclamation to renew the fee extends it for an additional year. The administration also issued an executive order that would further scrutinize companies seeking to hire H-1B workers, particularly organizations that directly or indirectly had layoffs within the previous year or plans future layoffs impacting U.S. workers. The renewal of the $100,000 H-1B fee is separate from the Department of Homeland Security’s proposed $103,265 filing fee for H-1B visa petitions that are subject to statutory numerical caps.”
  • Per a Health Resources and Services Administration news release,
    • “The Health Resources and Services Administration (HRSA) today announced nearly $19 million in new awards to expand access to high-quality healthcare through telehealth and technology-enabled learning. Announced during Telehealth Awareness Week, the awards will increase access to nutrition services, expand the use of emerging technologies to improve healthcare delivery, and strengthen the healthcare workforce in rural communities and other areas with limited access to care.
    • “Telehealth and innovative technologies are changing what access to healthcare looks like for Americans,” said HRSA Administrator Tom Engels. “No longer is telehealth the exception to the rule — it is an essential part of the healthcare system, and the Trump Administration is helping providers put these tools to work to expand access and improve health outcomes. For a patient in a rural community, that can mean getting specialized care without traveling hours from home. For a clinician, it can mean having expertise and new tools at their fingertips to better serve their patients. Through these investments, HRSA will help test what works and identify successful approaches that can be replicated in communities across the country.”
    • “The awards announced today include:
      • “Telehealth Centers of Excellence ($8.5 million) will pilot and test innovative telehealth solutions to expand access and improve health outcomes.
      • “Telehealth Nutrition Services Network Grant Program ($5.4 million) will increase access to nutrition services that help prevent and manage chronic diseases through telehealth networks.
      • “Technology-enabled Collaborative Learning Program ($4.75 million) will improve provider retention and expand access to care in rural communities using technology-enabled learning models.
    • “These awards build on HRSA’s leadership in telehealth by advancing innovative, high-value programs that expand access to high-quality care. HRSA’s broader telehealth portfolio includes more than 3,600 awards associated with telehealth.”

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

  • Federal News Network reports,
    • “After finding little change in the number of adverse actions taken against federal employees, the Office of Personnel Management is now looking for more feedback on how to “appropriately incentivize” federal managers to take action.
    • “The push comes after OPM released new data showing that for fiscal 2026, adverse actions involving poor performance and misconduct have been on par with last year.
    • “As of June 2026, OPM reported that there have been 3,105 federal employee terminations and separations based on poor performance or misconduct governmentwide. That’s compared with 3,492 in all of fiscal 2025 — excluding only the Postal Service, intelligence agencies and some other smaller government entities.
    • “Despite President Trump’s significant changes to how federal agencies address poor performance and misconduct, the federal government has not seen significant increases in performance-based and adverse actions,” OPM said in a Sept. 15 Federal Register notice.
    • “As a result of its findings, OPM reopened a public comment period and is soliciting feedback for an additional two weeks on a recent proposal to overhaul agencies’ processes for taking performance-based and adverse actions against federal employees.”
  • and
    • “Agencies will now be able to more easily offer bonuses of up to $25,000 to federal employees for exceptional work. The Office of Personnel Management is delegating authority to agency leaders to approve larger bonuses for feds. Previously, bonuses of that size required OPM approval. OPM says it’s removing the hurdle as a way to help agencies distinguish high levels of performance.” 
  • Serving Those Who Serve discusses funding an health savings account in retirement and optimizing a conversion to a Roth IRA.

From the Food and Drug Administration front

  • Per an FDA news release,
    • “The Food and Drug Administration’s Innovative Science and Technology Approaches for New Drugs (ISTAND) program has accepted a letter of intent (LOI) for a wearable sensor-derived digital outcome measure intended to quantify foot drop severity and its impact on gait in adult patients with Charcot-Marie-Tooth disease type 1A (CMT1A), a progressive, degenerative disease. This LOI represents the first submission to be accepted into the ISTAND program for a digital health technology (DHT) for a rare neurological condition.”
  • OncLine reports,
    • “The FDA has granted final approval to lutetium Lu 177 dotatate (Bravnetsa; PNT2003), a lutetium Lu 177 dotatate (Lutahera) biosimilar for the treatment of adult patients with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.1
    • “The agent was approved through the FDA’s abbreviated new drug application pathway, and the agency determined it to be bioequivalent and therapeutically equivalent to the reference product.
    • “As the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to lutetium Lu 177 dotatate approved in the United States, [the biosimilar’s] approval marks an important milestone, bringing additional treatment options to people living with GEP-NETs,” said Mary Anne Heino, executive chairperson and CEO of Lantheus in a news release. “We are focused on a thoughtful launch and ensuring the right commercial and operational capabilities are in place to support reliable supply and broad patient access.”
  • Fierce Pharma relates,
    • “Merck’s Winrevair continues to steadily expand its reach. A new FDA sign-off updated the pulmonary arterial hypertension (PAH) blockbuster’s label to include new data on patients who are newly diagnosed with PAH and receiving treatment for other conditions. * * *  Winrevair came out of Merck’s $11.5 billion buyout of Acceleron in 2021. The drug is a key part of the drugmaker’s plans to offset looming off-patent Keytruda competition.   
    • “Nuvation Bio also has a label addition to boast about. The FDA update allows the oncology drugmaker to add 14 months of additional data to the label of its CNS-active oral tyrosine kinase inhibitor, Ibtrozi. Ibtrozi is cleared by the FDA to treat locally or advanced metastatic ROS1-positive non-small cell lung cancer. Now, the added data from Nuvation’s Trust-I study showed a median duration of response of nearly 50 months in patients who had not received a tyrosine kinase inhibitor. That’s more than four years of “sustained clinical benefit,” the company said in a statement.  The updates came with no changes to the drug’s safety profile.”
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has cleared the X°Port Heart Preservation System from Ontario-based Traferox Technologies. The new device offers static 50 degrees F (10 degrees C) heart preservation during transport prior to transplantation, which has been shown in studies to improve outcomes.
    • “Peer-reviewed evidence has linked 10 degrees C heart preservation to reductions in severe primary graft dysfunction and improved post-transplant survival compared to conventional ice storage and exposure to hypothermic temperatures. Improved outcomes were also seen involving transplants of higher-risk donor hearts.[1,2]
    • “The strong clinical evidence supporting 10 degrees C heart preservation, together with the successful adoption of 10 degrees C preservation across leading lung transplant programs, has demonstrated the potential of this approach to improve donor organ preservation and transport,” Rick Mangat, PhD, chief executive officer of Traferox, said in a statement. “We look forward to working with transplant centers across the US to support the continued adoption of 10 degrees C preservation in routine clinical practice.”

No Surprises Act news,

  • Bloomberg Law reports,
    • “The Trump administration is launching a program to audit arbitrators of disputes between doctors and insurers under the No Surprises Act, stepping up oversight of a process plagued by litigation since it took effect in 2022.
    • “The law bars doctors from balance-billing patients for unexpected out-of-network care in emergencies and when procedures are performed by out-of-network providers at in-network facilities. While it’s largely shielding patients from surprise bills, implementation has increased medical spending, triggered a wave of lawsuits and raised allegations of bad actors on both sides.
    • “The new audits by the Centers for Medicare & Medicaid Services will “allow the Departments to more closely review the work done” by arbitrators, also known as “independent dispute resolution entities,” or IDREs, a spokesperson said.
    • “These audits will assess certified IDR entities’ full compliance with the NSA and its associated regulations and are anticipated to be a much more in-depth review of the process, programs and operational policies utilized by certified IDR entities,” the spokesperson said.”

From the fraud, waste, and abuse front,

  • Beckers Hospital Review reports,
    • “CMS said Sept. 22 that it canceled plan year 2026 ACA policies covering 760,000 people.
    • “CMS canceled 315,000 policies covering these individuals Aug. 31. According to federal rulemaking records — set to publish in the Federal Register on Sept. 23 — these people enrolled with agent or broker help but lacked verified citizenship or immigration documentation. Policy issuers could not identify claims or contact these consumers, either. During a Sept. 22 press conference, Vice President JD Vance said the government will do “additional verification” concerning legal status and income for 419,000 people.
    • In a Sept. 22 news release, CMS said it is anticipating a return of about $2.2 billion in advance payments of the premium tax credit. The removals were spearheaded by the White House Task Force to Eliminate Fraud. 
    • “CMS is also temporarily freezing new agent and broker registrations with federally facilitated exchanges for plan year 2027. This pause will be in effect until Feb. 1. The rulemaking documents said that based on two methodologies, agent and broker noncompliance leading to unauthorized enrollment could amount to roughly $1.5 billion or $6.6 billion in annual improper federal spending.
    • “Temporarily pausing the registration of new agents and brokers narrowly targets the category of agents and brokers that CMS has determined warrant additional scrutiny, while allowing CMS time to implement additional safeguards designed to prevent unauthorized enrollments and other noncompliant practices before new agents and brokers begin assisting consumers on the federally-facilitated exchanges,” the rulemaking document said.
    • “In the release, CMS said it will take on further work with insurance companies to address what may be unauthorized enrollments, focus on terminating noncompliant brokers and agents, and carry out other integrity efforts.”
  • Fierce Healthcare relates,
    • “Health tech company Cotiviti is building out its payment accuracy platform for payers with two new additions that will allow plans to see all inpatient claims in one place.
    • “The company said in an announcement that the enhanced platform reduces administrative complexity and unites elements that insurers typically managed through separate programs or vendors. Reducing those silos can support more accurate claims management, Cotiviti said.
    • “The first add-on is called Itemized Bill Review, which digs into high-cost facility claims to identify potential billing errors including miscoding, upcoding or duplicative charges. The Inpatient Coding Validation tool, meanwhile, supports a stronger diagnosis-related group review process that offers a fuller coding and clinical analysis before payments are made.
    • “Cotiviti said that the tools taken together can identify between 9% and 12% in additional errors for submitted inpatient claims, alongside simplifying the process on the payer’s end.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Suicide moved into the 10 leading causes of death in the U.S. in 2024, even as the number of suicide deaths declined from the year before.
    • “The finding comes from the CDC’s National Center for Health Statistics’ Sept. 22 report, “Deaths: Leading Causes for 2024.” The report is based on final mortality data from all death certificates filed in the 50 states and the District of Columbia in 2024.
    • “According to Paul Nestadt, MD, medical director at the Johns Hopkins Center for Suicide Prevention, limiting access to firearms could have the greatest effect on preventing suicide deaths and “will save the most lives.”  
    • “More than 28,000 people died by gun suicide last year — more than half of all suicide deaths nationwide, based on preliminary federal figures. The overall suicide rate has recently trended down, yet gun suicides have climbed to record levels for a fifth straight year. ” * * *
    • “The other leading causes, in order, were diseases of heart; malignant neoplasms; accidents (unintentional injuries); cerebrovascular diseases; chronic lower respiratory diseases; Alzheimer’s disease; diabetes mellitus; nephritis, nephrotic syndrome and nephrosis; and chronic liver disease and cirrhosis. The 10 causes accounted for 70.9% of all U.S. deaths.” 
  • Beckers Behavioral Health adds,
    • “The CDC released new data Sept. 21 showing improvements in several mental health, suicide risk, and dietary indicators among U.S. high school students from 2023 to 2025. 
    • “The findings are included in the CDC’s Youth Health in Focus report, which examines mental health and suicide risk alongside dietary behaviors, physical activity, sleep and digital behaviors. The report presents national Youth Risk Behavior Survey data from 2023 to 2025 and 10-year trends from 2015 to 2025.”
  • Beckers Hospital Review offers six things to know about the relationship betweek GLP-1 drugs and blindness due to nonarteritic anterior ischemic optic neuropathy (NAION)
    • “NAION is a rare condition that causes sudden, often permanent vision loss in one or both eyes. Sometimes called an “eye stroke,” the condition is caused by disrupted blood flow to the optic nerve. It typically affects people 50 and older, with an incidence of two to 10 cases per 100,000 people annually in that age group, according to the American Academy of Ophthalmology.” * * *
    • “Research remains mixed. A 2024 Mass General Brigham and Harvard Medical School study and a 2025 study in Diabetes, Obesity and Metabolism found an association between semaglutide and NAION but did not establish causation. Other studies, including a Novo Nordisk-funded study from earlier this year, found no association.” * * *
    • “NAION is not the only eye condition studied in connection with GLP-1s. A 2025 study found semaglutide users had a higher risk of neovascular age-related macular degeneration, and the American Academy of Ophthalmology and North American Neuro-Ophthalmology Society have said semaglutide may also worsen diabetic retinopathy, causing macular complications and blurry vision. A 2024 study first drew wide attention to a possible NAION association, and a follow-up study later that year also found an association.”
  • Health Day relates,
    • “Wildfire smoke might pose a greater health risk to humans than other sources of air pollution, two new Mount Sinai studies say.
    • “Particle pollution from wildfires appears to diminish the survival odds of lung cancer patients, a study published Sept. 15 in The Lancet Oncology found.
    • “Wildfire smoke is also linked to an increased risk of hospitalization for heart or lung disease, researchers reported Sept. 17 in the journal Nature Communications.
    • “Wildfire smoke is no longer a regional environmental issue. It is becoming a nationwide public health challenge,” said Yaguang Wei, senior author of both studies. He is an assistant professor of environmental medicine at Icahn School of Medicine at Mount Sinai in New York City.
    • “Our research shows that wildfire-related (particle pollution) appears to be more harmful than equivalent levels of pollution from other sources,” Wei said in a news release. “As wildfire activity increases, public health and environmental policies must account for both the quantity and the source of air pollution.”
  • and
    • “Vitamin D may play a bigger role in pregnancy than simply supporting bone health.
    • “A new study suggests that optimizing vitamin D levels before and during pregnancy may improve outcomes for both mother and baby, including the risk of preterm birth.
    • “We learn about vitamin D’s role in bone health, but no one teaches us about the various roles in pregnancy, especially this relationship with preterm birth we are uncovering,” said study author Anjali Borsum, a student at the Medical University of South Carolina College of Medicine in Charleston.”
  • Cardiovascular Business tells us,
    • “When heart patients are diagnosed with severe aortic stenosis (AS), waiting any longer than six months to perform transcatheter aortic valve replacement (TAVR) is associated with worse long-term outcomes. That was the key takeaway from a new analysis published in Open Heart.
    • “The study’s authors highlighted the fact that asymptomatic severe AS is increasingly being treated. At the same time, however, it is still common for patients to wait and then undergo a follow-up clinical and imaging exam six to 12 months later. The group hoped to learn more about the potential impact TAVR timing may have on patient outcomes, performing a retrospective study on data from 149 patients treated at a single facility from 2021 to 2023. The mean age was 85.8 years old, and 36% of patients were men.” * * *
    • “Click here for the full analysis.”
  • The Wall Street Journal informs us,
    • “Roche ROP Holding said an obesity drug candidate met the main objectives of a midstage clinical trial by helping patients reduce their blood glucose and body weight.
    • “The Swiss pharmaceutical company is seeking to enter the weight-loss drug market that Eli Lilly LLY and Novo Nordisk NOVO currently dominate, and sees the latest trial results reinforcing its ambitions to rapidly develop a portfolio of medicines for people with obesity, diabetes and cardiovascular disease.
    • “Roche said its drug, enicepatide, achieved a mean reduction in blood-sugar levels of 2.65 percentage points, as well as a mean weight loss of 15.5%, after 48 weeks for patients who received the highest dose.
    • “The trial enrolled adults with Type 2 diabetes who also had obesity or were overweight, and follows an earlier study that showed the drug helped patients without diabetes shed weight.
    • “Among patients who were on the highest dose, 62% restored blood glucose to levels considered normal, having started the trial as diabetic, Roche said.
    • “The safety and tolerability profile of enicepatide was consistent with that of similar therapies, and treatment discontinuation rates in the trial due to adverse events were low at 2%, it said.”
  • BioPharma Dive points out,
    • “An experimental Amgen drug has succeeded in the first of two Phase 3 trials in Sjögren’s syndrome, driving the California biotechnology giant’s stock price up as much as 5% on Tuesday. 
    • “Amgen didn’t provide specific details about the performance of its drug dazodalibep. But it said in a Tuesday statement that treatment led to a “statistically significant and clinically meaningful improvement” on a widely used measure of disease activity after 48 weeks, meeting the trial’s primary objective. Positive effects were observed as early as four weeks after treatment and persisted through the evaluation period, Amgen said. 
    • “Investigators didn’t spot an “imbalance” in the rate of blood clots or opportunistic infections in the Phase 3 study, a potential concern of drugs with dazodalibep’s mechanism. Side effects were generally mild to moderate, and study discontinuations were infrequent and balanced across study arms, the company said.”
  • and
    • “Trial enrollees taking Viking Therapeutics’ dual-acting obesity drug maintained nearly all of their weight loss after switching from a weekly shot to less frequent dosing, the company said Tuesday.
    • “Viking enrolled 180 people with obesity and no related health conditions in the Phase 2 trial. They were randomized to receive one of four dosing regimens of VK2735 or a placebo over 21 weeks, and then switched to a biweekly or once-monthly maintenance shot for another 12 weeks. According to Viking, enrollees taking VK2735 ended up retaining as much as 90% of their weight loss.
    • “The “stellar” data “build on [VK2735’s] potentially differentiated profile,” Leerink Research analyst Thomas Smith wrote in a note to clients, potentially allowing the drug to overcome some of the adherence issues associated with GLP-1 medications for obesity.”

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

  • The Wall Street Journal reports,
    • “Western pharmaceutical companies are urging the administration to allow them to keep doing deals with Chinese companies for promising drug candidates, despite a 2025 law restricting U.S. investment in Chinese technology.
    • “The group that represents pharmaceutical companies such as Pfizer, Merck and Eli Lilly has been lobbying to make sure that the new rules the Treasury Department is writing, as part of that 2025 law, maintain the drugmakers’ ability to do deals in China.
    • “At stake are billions of dollars in deals and an increasingly important source of experimental drugs for Western companies, which they need to restock their pipelines as they face big upcoming revenue holes with key drugs losing exclusivity in coming years.
    • “The 2025 law, called the Comprehensive Outbound Investment National Security Act or COINS, requires the federal government to screen deals with certain countries involving sensitive technology. So far, the Treasury Department has been reluctant to fully incorporate pharmaceuticals, according to two people familiar with the matter, as it finalizes regulation for other technology under the law, like AI systems and semiconductors.
    • President Trump is meeting Chinese President Xi Jinping this week, a summit that pharmaceutical leaders believe will be instrumental in determining how far the administration goes with putting curbs on Chinese biotech investment. The rules need to be finalized by March.”
  • Beckers Hospital Review identifies 32 “contract breaks between major health systems and certain Medicare Advantage insurers [that have occurred in] 2026. Providers dropping plans often cite prior authorization denials and slow reimbursement; in other cases, insurers are terminating the contracts themselves.”
  • Kaufmann Hall tells us.
    • “For decades, rural healthcare has been organized primarily around hospitals and clinics connected through traditional referral relationships. But the pressures facing rural providers challenge that structure. Rural communities today are asking what a more sustainable approach should look like.
    • “The hub-and-spoke model is familiar to rural healthcare, concentrating complex services centrally while extending others into local communities. But today’s pressures demand an evolution of that approach. The network of tomorrow must combine physical care sites, digital capabilities, and trusted community connections to deliver the right care in the right place.
    • “That requires adding a new element: the node. The result is a hub-spoke-node network built around the patient.”
  • Beckers Clinical Leadership lets us know,
    • “Adult medical specialties posted the largest increase in median work relative value unit productivity from 2025 to 2026, the second consecutive year the category has led on productivity growth, according to a survey from SullivanCotter.
    • “The Chicago-based consulting firm released findings from its 2026 Physician Compensation and Productivity Survey Sept. 17. The report includes data from 575 healthcare organizations representing about 235,000 physicians across 240 specialties.
    • “Productivity gains were modest across the board, with year-over-year changes ranging from 0.8% to 2.8%. Median total cash compensation rose across all major specialty categories over the same period, led by adult medical specialties at 7.2%.”
  • and
    • “Is pneumonia contagious?” is the most-Googled respiratory health question in the U.S., drawing an estimated 137,000 searches per month, according to a Sept. 22 analysis from healthcare staffing firm Soliant Health.
    • “The data offer a glimpse at patients’ health concerns heading into the 2026-27 virus season. 
    • “To compile the ranking, Soliant Health analyzed 30,000 question-based search queries in September using data from the search engine optimization platform Ahrefs. Soliant identified the medical questions tied to respiratory illness season and ranked them by estimated monthly U.S. search volume. The firm excluded branded queries, entertainment searches and near-duplicate questions. 
    • “Together, the 15 questions draw more than 731,000 estimated searches a month, according to a Sept. 22 news release shared with Becker’s.
    • “Alongside traditional internet search engines, AI platforms are emerging as another key tool patients use to find health answers. Thirty-four percent of Americans use AI chatbots for health information, and symptom diagnosis is one of the top reasons, according to a Pew Research Center survey released in August.”
    • [The article lists the top 15 Googled questions.]
  • Drug Channels notes,
    • “For more than a decade, the answer to “Where do drug wholesalers make their money?” has been generic drugs.
    • “Although wholesaler revenues are linked most closely to sales of brand-name drugs, the majority of wholesalers’ gross profits comes from generic drugs. We estimate that in calendar year 2026, generic drugs will contribute 52% of total drug distribution gross profits of the Big Three wholesalers, but only 9% of drug distribution revenues.
    • “Generic drugs are the long-running hit show that has carried wholesalers’ profits for 15+ seasons. The show is still on the air, but a supporting character is starting a spinoff.
    • “Generic drugs’ share of distribution gross profits has declined, from 68% in 2022 to 52% in 2026. This partially reflects the growth in profits from provider-administered biosimilars. Biosimilars now account for 6% of wholesalers’ drug distribution revenues, but 23% of total gross profits.”

Weekend update

David Ermer–CDC, Congress, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • The Senate is in session this week on Capitol Hill this week (following the Jewish holiday Yom Kippur. which begins at a sundown Sunday) for Committee business and floor voting.
  • Roll Call shares more details on this week’s Senate activities.
  • MedPage Today reports,
    • “Landmark legislation designed to alert consumers to where their drugs were made is headed for a full Senate vote, but safety experts say the transparency bill has been stripped of two of its most critical provisions.
    • “The Clear Labels Act was introduced earlier this year by Sens. Rick Scott (R-Fla.) and Kirsten Gillibrand (D-N.Y.) after lawmakers and drug safety experts called for more transparency in the industry. Last year, a ProPublica investigation revealed that the U.S. kept importing generic drugs from foreign factories after inspectors had identified quality and safety lapses at the sites, including leaks, mold, and contaminated water.
    • ‘Medications made at these facilities were linked to thousands of reported adverse reactions in patients.
    • “The bill aims to allow doctors and patients to see on the label exactly where a medication was made — details that had largely been withheld until now, even from Congress. Current generic drug labels often include only the location of the packager or distributor, which can be thousands of miles away from the actual manufacturer.
    • “One provision made the law particularly strong, experts said: The label was supposed to include a unique code that the FDA uses to identify factories. That code would have made it easier for researchers and the public to track the regulatory histories of specific facilities.
    • “The requirements also were supposed to take effect as early as a year after the bill’s passage.
    • “Senators have now struck both of those provisions. People familiar with the deliberations said lawmakers worried the requirements would raise drug prices and weaken national security by revealing the precise locations where lifesaving medications are made.
    • “The unique identifier requirement has been removed from the bill, and the timeline for companies to come into compliance was extended to 5 years.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention is seeking public input on how data intermediaries, such as health information exchanges and other data-sharing entities, can support secure, scalable, standards-based public health data exchange. Comments submitted for the request for information will be used to evaluate ways to improve interoperability, reduce reporting burdens and enhance the timeliness and usefulness of data for public health while protecting privacy.
    • “CDC said the effort builds on its data modernization initiatives and seeks feedback on how intermediaries can help address ongoing challenges related to data silos and information sharing across the healthcare and public sectors. Comments are due by Nov. 20.”

From the judicial front,

  • Beckers Payer Issues reports,
    • “Several HCA Healthcare-affiliated hospitals in Texas filed a lawsuit Sept. 11 against Pennsylvania insurer Independence Blue Cross over alleged claim denials.
    • “The plaintiffs include Methodist Healthcare System of San Antonio, St. David’s HealthCare, HCA Houston Healthcare North Cypress, The Woman’s Hospital of Texas and HCA Houston Healthcare Medical Center — all tied to Nashville, Tenn.-based HCA Healthcare.
    • “The lawsuit, filed in a Pennsylvania federal court, argued the insurer needed to reimburse these hospitals under the BlueCard Program, which allows members of one Blue Cross Blue Shield Association licensee plan to receive covered care access in another licensee’s service area. In this case, the hospitals contract with BCBS Texas. The complaint also said IBX represented the hospitals as “in network.”
    • “The complaint said IBX owes the hospitals at least $345,319 under the agreements. The lawsuit outlines alternative legal theories, such as “implied-in-fact contract,” to challenge IBX’s reimbursement approach, as well.”
  • The Wall Street Journal relates,
    • “Michelle Fennell was sitting at her desk when her right eye started feeling heavy. Suddenly, it was blurry and her peripheral vision waned. It felt like she was looking through a fishbowl; she could see straight ahead but not to her right or down. 
    • “Two weeks later, a doctor diagnosed Fennell, 53 years old, with nonarteritic anterior ischemic optic neuropathy, or NAION, a condition that leads to sudden, often permanent vision loss.
    • “The doctor asked what medicines she was taking. “He said right away, stop taking Ozempic,” to protect her remaining vision, said Fennell, who started taking the drug to treat her Type 2 diabetes six months prior. “I was shocked.” 
    • “Some emerging scientific research points to an increased risk for patients taking certain GLP-1s to develop NAION. But the evidence is mixed, and not clear enough to say whether or how the drugs cause the condition, doctors and researchers said.
    • “Fennell is one of dozens of people suing Novo, maker of the popular weight-loss and diabetes drugs Wegovy and Ozempic, claiming the medication caused this side effect. There are also a similar but smaller number of lawsuits against Eli Lilly, maker of Zepbound. Both companies are fighting the litigation, saying there isn’t enough evidence to support the idea that drugs are to blame.”

From the public health and medical / Rx research front,

  • The Hill reports,
    • “Doctors in Texas say they have seen an increasing number of otherwise healthy young men coming in on the brink of organ failure. 
    • “The health care practitioners told Texas Monthly they believe the culprit is CKDu, or chronic kidney disease of unknown origin, an unexplained form of kidney disease that can quickly turn deadly.
    • The disease has also been called Mesoamerican Nephropathy, a reference to the region it’s more typically found in, Central America. It’s also been identified in Sri Lanka. Researchers are now concerned it is growing in the United States, especially among agricultural workers and laborers. 
    • People with CKDu don’t have the classic risk factors of kidney disease, like hypertension or diabetes. Most people affected by the disease are Latino men ages 20 to 60. Often, they work under extreme conditions.
  • The Washington Post relates,
    • “The reported success of an experimental drug that uses messenger RNA to deliver personalized skin cancer vaccines could herald a wave of new treatments that harness the potent technology for a range of cancers, researchers say.
    • “Drugmakers Moderna and Merck this summer announced that a cancer vaccine, intismeran autogene, had succeeded in a Phase 3 clinical trial in preventing the recurrence of melanoma, a result experts celebrated as a breakthrough for mRNA-based cancer treatments. 
    • “Trials investigating mRNA vaccines for lung cancer, pancreatic cancer and other diseases are already underway. They use the same approach as intismeran that might once have seemed like science fiction: analyzing a tumor sample to create a vaccine customized to target its specific mutations, so each patient receives a unique drug for their cancer.
    • “Some of these treatments are still years or decades from fruition, if they prove to be effective, but researchers said the still-nascent field of mRNA vaccines could eventually transform our approach to cancer care.
    • “It is not too far-fetched to consider that in the future, when one is diagnosed with cancer, part of your specimen is going to go to the pathologist, who’s going to confirm the cancer [diagnosis],” said Dan Costin, director of the White Plains Hospital Center for Cancer Care in New York and a lead investigator in an mRNA lung cancer vaccine trial. “And the other part will be going to a laboratory where they will be preparing a special vaccine.”
  • Medscape tells us,
    • “GLP-1 medicines for weight loss do cause some muscle loss, but current research suggests this is usually a normal part of losing weight and not unique to these drugs. The debate is really about how careful we should be in older or already frail people.
    • What happens to muscle with GLP-1 weight loss?
      • GLP-1 drugs (like semaglutide and tirzepatide) lead to large weight loss; about one-quarter to one‑third of that loss is “lean mass,” which includes muscle, organs, water, and bone, not just muscle alone.1When researchers adjust for the non‑muscle parts of fat tissue, the estimated lean loss with semaglutide drops from 39% of total weight lost to about 30%.2 Studies of people losing similar amounts of weight with bariatric surgery show a very wide range of lean‑mass loss (about 12–44%), so GLP‑1 drugs do not appear to cause an unusual or “extra harmful” pattern compared with other ways of losing weight.1 Importantly, in trials where people lost a lot of weight on GLP‑1s, physical function and mobility usually improved, even though some lean mass was lost.
    • Who might need extra caution?
      • Experts agree most typical middle‑aged adults with obesity are not becoming frail from GLP‑1 treatment.1 Concern is higher for: –
        • Older adults, especially over 60 –
        • Post‑menopausal women – P
        • People with sarcopenic obesity (high fat, low muscle) or other illnesses (heart disease, fatty liver, sleep apnea, major weight cycling)1
      • In these groups, losing too much muscle could worsen balance, strength, and fracture risk.
  • Health Day informs us,
    • “Getting enough sleep is important for your health — but the type of sleep you get may matter, too.
    • “A team led by Jingsong Luo of Peking University in China tracked more than 95,000 adults who wore wrist monitors for seven days and nights, measuring REM, deep sleep and light sleep.
    • “Over the next nine years, they checked health records for links to more than 1,000 different diseases.
    • “The result: More REM sleep was linked to a lower risk of 83 diseases, including heart failure, dementia, Parkinson’s, Alzheimer’s and multiple sclerosis.
    • “More deep sleep was tied to lower risk of seven conditions, including type 2 diabetes, major depression and sleep apnea.
    • “REM sleep is when most dreaming happens, while deep sleep is the most restorative stage.
    • “The findings also underscore the importance of getting six to eight hours of sleep a night.”

From the U.S. healthcare business front,

  • Beckers Clinical Leadership discusses better ways for our health system to handle chronic illnesses.
    • “[A]dvances – nutritional interventions, bioelectronic medicine, robotics, community-based care – are not isolated innovations. Together, they represent a strategy to reduce the burden of chronic disease on the more than 190 million Americans living with it today. When prevention works, the cost of care comes down. When communities are healthier, demand for expensive interventions falls.
    • “The path forward is clear, even if it isn’t easy. Chronic disease will not be tamed by any single breakthrough. It will be tamed by a sustained, systemwide commitment to prevention – investing in food, technology, relationships and community before a patient ever needs a hospital bed. Every health system, payer and policymaker should be asking the same question we ask ourselves: are we doing everything we can to keep people healthy before they need us? That is where the opportunity is. And that is where we intend to lead.”
  • Beckers Payer Issues relates,
    • “Marisa Rogers, MD, has left her role as chief medical officer for Oak Street Health, CVS Health’s primary care company for older adults.
    • “We built our clinical teams, invested in our leaders, advanced our care model, improved quality, and navigated more change and transformation than I could have imagined,” Dr. Rogers said in a Sept. 18 LinkedIn post. “I’m proud of what we accomplished together and even more grateful for the people I shared it with.”
  • Healthcare Dive reports,
    • “Almost 12 million Americans can’t access telehealth services because they don’t have enough broadband to support a reliable virtual care connection, according to new research published Friday in JAMA Health Forum.
    • “The majority of impacted individuals live in rural areas, highlighting how inadequate infrastructure and pricey broadband subscription rates are preventing traditionally underserved Americans from getting virtual access to primary, specialty and emergency care, researchers with the University of Vermont said.
    • “Affordability, low digital literacy, inadequate technology and a lack of availability of telehealth services are also hindering telehealth access.’

Cybersecurity Saturday

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

From the frontier AI front,

  • The Wall Street Journal reports,
    • “Google’s Gemini model accessed the internet and hacked other companies during a test of its cybersecurity capabilities, the first known example of the company’s artificial-intelligence systems autonomously committing such an act. 
    • “The hacks, which the company confirmed on Friday [September 18], occurred in May as part of a test run by the company Irregular, which was also involved in similar incidents disclosed by OpenAI, Anthropic and Meta. 
    • “In one of the cases, the model guessed passwords until it gained access to a protected system. In the other two cases, the model found credentials in a public repository that allowed it to then access protected systems. In each case, the model ended the intrusion after determining it had accessed a real company’s systems, Google said.
    • “Irregular notified Google about the hacks at the end of July, Google and Irregular said, in the wake of the discovery that OpenAI’s agents had hacked the AI software company Hugging Face. Google didn’t disclose the hacks until The Wall Street Journal reached out with inquiries this week.” * * *
    • “Worries about the cybersecurity capabilities of new models have increased since the July discovery of the Hugging Face hack. In that case, up to 1,200 agents coordinated on a secret message board inside OpenAI to try to cheat on an evaluation, a report by the third-party testing company METR revealed in August. 
    • “Last week, those concerns spilled into the mainstream after the dramatic quitting of Jacob Coxon, a former OpenAI researcher who had gone to Anthropic earlier this year. Over the weekend, leaders from Anthropic, OpenAI, Google and SpaceX all agreed on the need to slow down the rate of AI progress, although none of the companies have outlined exactly how that would happen.”
  • and
    • “The WSJ Technology Council Summit kicked off Monday afternoon [September 14] in New York City with an informal poll of the audience during a town hall conversation. In a show of hands, only a few people said they feared that AI could kill us all in the next decade, while about half of attendees indicated that they were in support of slowing down AI development at the frontier and prioritizing safety guardrails.
    • “But that slowdown didn’t apply to the deployment of AI within their organizations, where not all models are at the cutting edge and even the most advanced of them tend to be relatively well understood and tested by experience.
      “It’s in our hands and it’s up to us to apply [AI] for good, and I think it can do a lot of good for society,” said Vishal Talwar, president, FedEx Dataworks, and chief digital and information officer, FedEx.
      “Much of ensuing town hall discussion focused on the myriad ways in which companies were operationalizing AI.”
  • Cyberscoop adds,
    • “The AI hacking apocalypse is not inevitable.
      • “While large language models present real risks to society, experts say they can be tested and largely controlled using well-worn cybersecurity and policy choices.”
      • “Juan Andres Guerrero-Saade, a fellow for AI and security research at SentinelOne and an adjunct professor at Johns Hopkins University, said the hacks are worth taking seriously, but at a time when businesses and open-source maintainers should be focused on further hardening their systems and policymakers should be discussing new solutions, “what we see is cybersecurity being used essentially as an excuse for these AI doomer arguments.” * * *
      • “Guerrero-Saade is among a growing chorus of cybersecurity professionals who say that while AI systems pose real, unique threats to our systems, the apocalypse is far from inevitable. Most of the public concerns around the incidents, let alone worries about killer AIs attacking critical infrastructure, assuming control of the internet and wiping out humanity, are either technically impossible or can largely be controlled through established cybersecurity principles.
      • “There is this “narrative or magical thinking of ‘Well, AI is going to be able to hack everything, and therefore it can control everything, and therefore it’s going to kill us all,’” he told CyberScoop. “And you [think] these just don’t add up. They’re not very well-reasoned arguments.”
      • “This fatalistic narrative tied to AI’s eventual dominance doesn’t hold up under scrutiny, according to experts CyberScoop spoke with. In recent conversations, cybersecurity and national security professionals raised questions about both the technical solutions OpenAI and Anthropic use to contain their models, as well as the glaring absence of federal oversight from federal regulators or truly independent third-party review.”

From the cybersecurity policy and law enforcement front.

  • Per a Senate Finance Committee news release,
    • “U.S. Sens. Mark R. Warner (D-VA) and Ron Wyden (D-OR) today reintroduced the Health Infrastructure Security and Accountability Act, legislation to improve cybersecurity in our health care system amid a growing wave of cyberattacks that are compromising Americans’ sensitive information and disrupting access to critical care across the country.” * * *
    • “Specifically, the Health Infrastructure Security and Accountability Act would require the Department of Health and Human Services (HHS) to establish, enforce, and regularly update strong minimum cybersecurity standards for health care providers, health plans, clearinghouses, and business associates, with heightened standards for systemically important entities and entities critical to national security.
    • “The legislation would also require covered entities to develop continuity plans describing how it would resolve a tech failure or intrusion, conduct annual cybersecurity tests, and undergo independent security audits, while increasing fines for failure to meet security requirements and strengthening HHS oversight through annual cybersecurity audits. Additionally, this legislation would provide $1.3 billion to help hospitals strengthen their cybersecurity, including $800 million for hospitals in rural and underserved urban communities.
    • “Full text of the bill can be found here. A summary of the bill can be found here.”
  • Cybersecurity Dive reports,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) will stop publishing weekly roundups of newly disclosed software vulnerabilities at the end of September, the agency announced on Thursday.
    • “CISA is ending its Vulnerability Bulletin “as part of its shift from severity‑based vulnerability management to a modern, risk‑based approach,” the agency said in a statement.
    • “The weekly bulletins, published since early 2004, listed vulnerabilities published during the reporting period along with their CVEs, severity scores and brief descriptions.” * * *
    • “CISA said in its Thursday statement that sunsetting the bulletin aligns with the prioritization directive it issued in July, “which directs federal agencies to prioritize vulnerabilities based on real‑world risk factors, including evidence of exploitation and exposure, rather than severity scores alone.”
    • “As it discourages organizations from relying solely on Common Vulnerability Scoring System (CVSS) scores to decide which vulnerabilities to fix, CISA has also been highlighting the Stakeholder-Specific Vulnerability Categorization (SSVC) system as a more nuanced approach to vulnerability analysis.
    • “Chris Butera, CISA’s acting executive assistant director for cybersecurity, said on Wednesday at Google’s Cyber Defense Summit that the agency has been discussing SSVC with companies that sell vulnerability management software. “They’re building some of this prioritization into their vulnerability tooling,” Butera said.”
  • and
    • “The Cybersecurity and Infrastructure Security Agency (CISA) wants to hire critical infrastructure experts with broad, rather than specialized, knowledge as it tries to help defend the infrastructure community with limited resources.
    • “I need to be able to hire people that are highly adaptive, because I think the threat is continuing to evolve so much, and the exposure that we have within these critical infrastructure sectors is evolving so much,” acting CISA Director Nick Andersen told reporters after speaking at Google’s Cyber Defense Summit here on Wednesday [September 16]. “I need people that can pivot from day to day to be able to help meet all of these stakeholders where they are.”
    • “Andersen’s comments come as CISA prepares to onboard roughly 250 new employees as part of a hiring sprint meant to fill critical vacanciescreated by the Trump administration’s sweeping downsizing of the agency over the past two years. As ransomware gangs and nation-state hacker groups increasingly menace infrastructure operators, in some cases aided by destabilizing advances in AI, CISA’s supporters say its mission — and its partnerships — have become more important than ever.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) today [September announced a settlement with Ambry Genetics Corporation (Ambry) concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. Ambry, headquartered in Aliso Viejo, California, is a covered entity that provides genetic testing and clinical genomics services.
    • “In January of 2020, Ambry discovered that an employee’s email account was compromised by a phishing attack. The protected health information (PHI) of 225,370 individuals was potentially exfiltrated by the threat actor. Affected PHI included names, addresses, dates of birth, some Social Security numbers or driver’s license numbers, financial information, diagnoses and conditions, lab results, medications, and treatment information.” * * *
    • “The settlement resolves an investigation that OCR initiated after Ambry filed a breach report in March 2020 about the phishing incident that occurred in January 2020.  OCR found that Ambry had potentially violated provisions of the Security Rule, including:
      • “Failing to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the electronic protected health information (ePHI) held by Ambry;
      • “Failing to implement procedures for terminating access to ePHI when the employment of or other arrangement with a workforce member ends or access is no longer appropriate; and
      • “Failing to assign a unique name and/or number for identifying and tracking user identity in electronic systems containing ePHI.” * * *
  • “The resolution agreement and corrective action plan may be found at https://www.hhs.gov/sites/default/files/ocr-ra-cap-ambry-genetics-corporation.pdf [PDF, 51.88 MB].”
  • Cyberscoop adds,
    • “Another core member of the hacker subset of The Com involved in a spree of extortion attacks from at least 2021 to 2023 pleaded guilty to federal charges, according to court records released Tuesday.
    • “Ahmed Hossam Eldin Elbadawy, a 24-year-old from Texas, pleaded guilty exactly one year ago to wire fraud conspiracy and aggravated identity theft. His guilty plea wasn’t shared publicly until prosecutors filed an order of forfeiture this week seeking proceeds from Elbadawy’s criminal activities. 
    • “Elbadawy and his co-conspirators — Noah Michael Urban, a Florida man sentenced to 10 years in prison last year, and Tyler Robert Buchanan, a Scottish man who pleaded guilty to multiple cybercrimes in April and awaits sentencing — were part of an aggressive subset of The Com coined Scattered Spider.”
  • and
    • “Authorities seized the primary domain and other websites linked to NightmareStresser, one of the longest-running and most popular distributed denial-of-service operations used by cybercriminals globally, the Justice Department said Tuesday. 
    • “Cybercriminals of various motivations used the DDoS-for-hire service to launch hundreds of thousands of DDoS attacks or attempted attacks since at least 2022, officials said. 
    • “The takedown, part of an ongoing globally coordinated effort dubbed “Operation PowerOFF,” marks law enforcement’s continued targeting of IP stressers or DDoS booters that inundate websites, servers and networks with junk traffic, rendering legitimate sites inaccessible. The seizures were executed by the FBI Anchorage field office and the Royal Canadian Mounted Police.”

From the cybersecurity vulnerabilities and breaches front

  • HIPAA Journal notes,
    • “A hacking group has claimed responsibility for an August 2026 cyberattack on Cedar County Memorial Hospital in Missouri. Hacking-related data breaches have been reported by Next Level Medical in Texas and Grafton City Hospital in West Virginia.”
  • MSSP Alert adds,
    • “Artificial intelligence is fundamentally altering the economics of cybercrime, making attacks faster and less expensive to execute, as first reported by Channel Insider. Ransomware victims saw a 45% increase in the first half of 2026, while the average underground price for initial access dropped by 69%, from $1,427 to $439. This shift indicates that AI is enabling threat actors to target more organizations with greater speed and scale, even if individual attacks are not necessarily more successful.”
  • Cyberscoop reports,
    • “Researchers said they used Anthropic’s Claude and OpenAI’s Codex to identify a damaging flaw embedded in a popular software decoding tool that could leave major internet platforms, enterprise services, and web frameworks vulnerable to data theft and remote access.
    • “The vulnerability, nicknamed HEIF Heist, refers to the malware’s ability to trigger memory corruption errors in affected software, allowing the attacker to pilfer sensitive data from its victims. In a report published Thursday, the researchers laid out the potential damage an attacker could cause, including gaining access to internal OpenAI repositories, leaking user files, access tokens, and other sensitive data for online services like Amazon Web Services, and gaining remote code execution privileges across a range of online services, including Meta’s core product suite, GitHub Enterprise servers and open-source internet forum Discourse.”
  • and
    • “North Korean hackers are infiltrating tens of thousands of job seekers’ computer networks by posing as prospective employers, such as artificial intelligence firms, to steal sensitive information and millions of dollars worth of cryptocurrency, U.S. and allied governments warned Friday.
    • The security agencies behind the alert, attributed the group, known as WaterPlum or Contagious Interview, as operating under the 313 General Bureau of the Munitions Industry Department subordinate to the Central Committee of the Workers Party of Korea. The efforts dovetail with those of North Korean IT workers.
    • “WaterPlum actors pose as prospective employers to target software developers and IT professionals worldwide under the pretext of attractive job opportunities,” the agencies wrote. “They often impersonate legitimate Artificial Intelligence (AI), cryptocurrency, or Non-Fungible Token (NFT) companies and have also used recruiting services.”
    • Additionally, “Some WaterPlum actors also operate as North Korean IT workers performing web system design and development tasks on corporate web systems for clients,” read the alert from agencies in Japan, Australia and Germany, alongside the FBI and the Department of Defense’s Cyber Crime Center.”
  • Help Net Security tells us,
    • “A fake ChatGPT billing email is steering users to a copy of the OpenAI login page that keeps whatever username and password they type. Josh Varden of Cofense’s Phishing Defense Center traced the email’s payment button through a Google redirect to the attacker’s page.
    • “The lure targets ChatGPT users on work and personal accounts alike, and it copies the kind of bill a subscriber already expects. Credentials entered on the fake page go to the attacker, and the victim is sent on to an error page.” * * *
    • “Cofense listed three indicators: the Google redirect link and two paths on the same nxcli[.]io host, login.php and key.php. Mail teams can search their logs for all three. If you use ChatGPT, the check that matters takes two seconds: read the address bar and confirm it says auth.openai.com before you type a password.”

From the ransomware front,

  • Industrial Cyber informs us,
    • “New data from Comparitech disclosed a record 997 ransomware attacks worldwide in August 2026, averaging 32 attacks per day and representing a 23% increase from 809 attacks in July. The total surpassed the previous monthly record of 988 attacks recorded in February 2025. Businesses accounted for 861 attacks, up 24% from July, while ransomware incidents targeting healthcare providers rose 30% to 69. Utility companies recorded the sharpest sector increase, with attacks doubling from five in July to 10 in August. 
    • “Ransomware surge was led by Qilin and The Gentlemen, which together accounted for more than 26% of August’s attacks, with Qilin claiming 157 incidents and The Gentlemen 107. Qilin’s attack claims increased 22% during the month, while The Gentlemen’s declined 21%; Qilin also had 12 confirmed attacks, compared with eight for The Gentlemen.” * * *
    • “Attacks on healthcare providers increased by 30% from July 2026 to August 2026, rising from 53 to 69. Eight attacks were confirmed in August. Three of the confirmed attacks took place in the U.S. Nutex Health Inc. noted unauthorized activity on its systems in a SEC filing on Aug. 24, 2026, and The Gentlemen claimed the attack. Cedar County Memorial Hospital experienced disruption to its IT networks on the afternoon of Aug. 14, 2026, with operations returning to normal on the morning of Aug. 28. Wallstreet claimed the attack. At Windrose Health Network, hackers exploited a vulnerability in the network’s remote-management tool in early August, resulting in a data breach. Storm claimed the attack.” 
  • Beckers Health IT reports,
    • “Jackson-based University of Mississippi Medical Center did not pay a ransom in connection with the cyberattack that disrupted its systems in February, according to officials.
    • “UMMC Vice Chancellor of Health Affairs LouAnn Woodward, MD, told SuperTalk Mississippi the state did not compensate hackers following the Feb. 19 attack. State Sen. Nicole Akins Boyd, who chairs the Universities and Colleges Committee, corroborated Dr. Woodward’s account.
    • “The statements come after State Auditor Shad White said his office would investigate the incident and notify the public if the government had paid a ransom.
    • “The cyberattack knocked out UMMC’s phones, website, records database and IT systems, forcing partner clinics to close for nine days and staff to record patient information by hand. The medical center returned to full operations Feb. 27.”
  • Cybersecurity Dive relates,
    • “Security researchers warn that a newly discovered ransomware variant called Settra has targeted virtual private network environments or compromised credentials for initial access before deploying remote monitoring and management tools to gain persistent access in targeted environments. 
    • “Researchers from Huntress observed two specific attacks in recent months, including a July incident at a consumer services and retail organization and a September incident at a manufacturing firm, according to a blog post published Thursday [September 17].
    • “The attackers could be described as capable rather than sophisticated,” said Lindsey O’Donnell-Welch, principal technical community engagement writer at Huntress. “They used effective, established ransomware tradecraft: MeshAgent for persistence, a vulnerable driver to potentially impair defenses, log clearing and recovery tampering.”
    • “Researchers from MoxFive said Settra used compromised VPN credentials to gain initial access and posted numerous victim organizations on its shaming site. The group claims to target organizations with exploitable weaknesses, such as unpatched systems or weak access management, according to a blog post from MoxFive.”
  • Bleeping Computer lets us know,
    • “The ShinyHunters extortion gang breached the Clop (aka Cl0p) ransomware operation’s data leak site, defacing the Tor site and allegedly stealing server data and the private keys for its onion service.
    • “The attack began Friday night [September 18] when ShinyHunters exploited what they claim is an unauthenticated file upload vulnerability in Grav CMS, which they used to upload a small text file to Clop’s site.
    • “The small text file contained a message from the threat actors to the Clop ransomware gang, warning not to threaten them and including a link to ShinyHunter’s own data leak site.”
  • InfoSecurity Mag tells us,
    • “It is a scenario that every CISO hopes they never face: the network encrypted by ransomware attack and cybercriminals who claim to have stolen sensitive data which they will leak if they don’t receive a ransom payment.
    • “Unfortunately for Zach Lewis, CISO at the University of Health Science and Pharmacy (UHSP) in St. Louis, this was the reality he faced when the organization was hit by a LockBit ransomware attack in summer 2023. The University recovered without paying the ransom, but it was a challenging time for all involved.
    • “In a conversation with Infosecurity, Lewis opened up about how it felt to be the victim of a ransomware attack and the toll it took on his team, as well as how the organization recovered from the incident and the lessons other cybersecurity leaders can learn from this experience.”

From the cybersecurity business and defenses front

  • The Wall Street Journal reports,
    • “Companies are facing a new era in cyberattacks driven by AI. But according to one cybersecurity CEO, having the right technology for defense isn’t necessarily the problem. It’s the humans who need to step up—particularly CEOs.
    • “What we’ve seen practically from working with some of the largest organizations in the world is that the technology is already there,” Galina Antova, CEO of the AI-driven security platform Kai, said at the Leadership Institute’s WSJ Technology Council Summit this week. “We could implement so many improvements,” using autonomous AI, she added.
    • “But what it really comes down to is having “the right incentive for the leaders to pursue that,” and “are they enabling their security organization to really move at machine speed?” 
    • “Companies need courage and leadership, she told enterprise tech bureau chief Steve Rosenbush, in a discussion that included Oege de Moor, founder and CEO of cybersecurity firm XBOW. 
    • Some additional insights from their conversation:
      • “Companies may need to redesign their security workflows. Attackers are “already moving at machine speed,” and they’re encountering a patchwork of protections, Antova reported. She has found that many Fortune 500 companies use some 80 to 120 security tools “that are organized in a very fragmented way,” she said. That means that when a company has an exposure, it can take time—days, weeks, or months—to find and close it. By contrast, she said, an end-to-end autonomous defense system that’s supervised by humans can reduce that time to minutes.” * * *
      • “[B]oth CEOs noted that the gap between frontier and open models was shrinking—and Antova added that with the right cybersecurity expertise and a surgical approach to deployment, the cost of AI-enabled security no longer needs to be prohibitive.”
  • Cybersecurity Dive adds,
    • “Artificial intelligence is now the leading driver behind new investment into cybersecurity budgets, according to a report released Tuesday from IANS and Artico Search.  
    • “About seven of every 10 chief information security officers surveyed said AI was their top priority for new cybersecurity spending. Two specific areas for AI-related spending shown in the report include automating security operations and enhancing identity and access management. 
    • “Overall security spending rose 5% in the current survey, which is barely ahead of the 4% spending increase in the year-ago report. AI spending priorities come at a time of relatively modest growth in overall security spending.”
  • Per CISA news releases,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) hosted Cyber Storm X this week, a four-day national cybersecurity exercise designed to test and ultimately strengthen the nation’s resilience. This year’s exercise included 2,000 participants from across the public and private sectors and marks the tenth exercise in the 20-year history of Cyber Storm. The biennial exercise brings together the people who manage the services our nation relies on, including water, energy, and other vital sectors. During the exercise, participants practice how they would respond to a major cyber incident affecting critical infrastructure.
    • “Cyber Storm helps critical infrastructure owners and operators understand how we would manage a large-scale cyber incident,” said Acting CISA Director Nick Andersen.  “Exercises strengthen our national resilience by making sure our plans, policies, and partnerships are ready when we need them.  As a nation, we need the ability to respond swiftly and effectively to critical threats. That’s exactly what Cyber Storm does and why it’s a vital exercise for our nation’s security.”
    • “This year’s exercise focused on a scenario involving a nation-state adversary targeting the transportation systems sector, including rail and ports, along with the water and wastewater systems sector. The exercise allowed participants to test response plans, practice coordination, and strengthen information sharing in a safe environment. Cyber Storm X included over two hundred organizations across all levels of government and the private sector.
    • “CISA will now collaborate with participating organizations to identify lessons learned from the exercise. We will use these findings in a public after-action report that captures observations, analyses, and recommendations. CISA is committed to providing access to a wide range of cybersecurity tools and training opportunities, with exercises being a critical part of that toolkit to enhance our nation’s cyber preparedness.
    • “For more information, please visit Cyber Storm X: National Cyber Exercise.”
  • and
    • “Today [September 16], the Cybersecurity and Infrastructure Security Agency (CISA) released guidance that helps critical infrastructure owners and operators implement realistic decoy systems and information assets to quickly detect and disrupt malicious activity occurring in their networks, which will ultimately improve their cyber defenses. Using Cyber Decoys to Strengthen Detection and Response is the first guide from CISA that offers a detailed explanation of the defensive cyber decoy process.
    • “Many organizations struggle to detect adversaries who use legitimate credentials, native tools, and living off the land techniques to conduct discovery, move laterally, and access data. In this guide, CISA encourages critical infrastructure organizations to incorporate cyber decoy capabilities alongside existing Zero Trust models. Cyber decoy strategies operate on the expectation that malicious actors may eventually gain some level of access. By placing decoys within internal networks and systems, especially in high-value areas, organizations can enable defenders to:
      • “Detect adversaries operating within the environment early in the intrusion lifecycle;
      • “Gather and analyze information taken from intrusions and attempted intrusions;
      • “Allocate defensive resources more effectively based on observed adversary behaviors;
      • “Reduce mean time to detection (MTTD) by generating high-fidelity alerts.” * * *
    • “To effectively use this guide, cyber defenders should have a basic understanding of the MITRE ATT&CK ® Matrix and common enterprise security controls and tools. The guide provides a practical approach to designing and implementing decoy strategies by leveraging the MITRE ATT&CK® knowledge base and the MITRE Engage™ framework.
    • “For more information, please visit Cybersecurity Best Practices.”
  • and
    • “The Cybersecurity and Infrastructure Security Agency (CISA) and the National Institute of Standards and Technology (NIST) today [September 15] released Interagency Report (IR) 8587, Protecting Tokens and Assertions from Forgery, Theft, and Misuse: Implementation Recommendations for Agencies and Cloud Service Providers (CSPs). The report guides federal agencies and CSPs in defending the identity tokens and assertions that underpin modern single sign-on (SSO), federation, and application programming interface (API)-based access, systems adversaries increasingly target to move laterally through enterprise networks and reach sensitive data.
    • “The final report incorporates key feedback from nearly 250 public comments on token validation, secrets management, and detection at scale. The report also reflects input from CISA’s long-term, strategic collaboration with industry CSPs and interagency partners through the Joint Cyber Defense Collaborative. CISA and NIST engagements with this group included a technical exchange in June 2025 with over 50 industry experts to identify approaches to harden identity infrastructure and a webinar in January 2026 to review the draft report. Dozens of individual meetings with CSPs were also held to discuss feedback that included Google, HashiCorp, an IBM Company, IBM, Microsoft Corporation, Okta Inc., the OpenID Foundation, Oracle America, Inc., Amazon Web Services, and Wiz.” * * *
    • “The recommendations in the final report apply across commercial and government-operated cloud services and support implementation of Executive Order 14306 on secure software development practices.
    • “CISA urges federal agencies, CSPs and cloud consumers to review and implement IR 8587 to improve the security of their cloud systems. 
    • “For more information on this effort, read NIST’s News Release.“
  • Tech Target offers a tip about “how to verify the value of AI-powered business analytics.”
    • Executives can separate AI analytics capabilities from marketing hype by taking steps to confirm the platform improves decision-making and gives results that hold up.
  • Here is a link to Dark Reading’s CISO Corner.

Thursday report

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

Happy Constitution Day!

From Washington, D.C.,

  • The American Hospital Association News reports,
    • “A Capitol Hill briefing Sept. 17 in Washington, D.C., hosted by 11 national healthcare organizations, including the AHA, highlighted the growing epidemic of workplace violence and its effects on staff well-being and patient safety. At the briefing, titled Protecting Those Who Care: Addressing Violence Against Healthcare Workers, Hill staff heard panelists’ personal experiences with physical and verbal attacks on the job and how hospitals are working to reduce the incidence of violence. The panelists were: Elizabeth Wells, M.D., executive vice president, chief clinical officer, and physician-in-chief, Children’s National Hospital; Jonathan Ripp, M.D., chief wellness officer and dean for well-being, Icahn School of Medicine at Mount Sinai; Tiffany Covarrubias-Lyttle, RN, associate professor of nursing, University of Lynchburg; and, Sheila Roth, Ph.D., professor emeritus, Carlow University. Reps. John Joyce, R-Pa., and Joe Courtney, D-Conn., also made brief remarks during the event.
    • “In a joint statement, the AHA and other participating organizations said, “Workplace violence, including physical assaults, threats, intimidation, and harassment, erodes the safety and dignity of healthcare workers, directly contributes to staff burnout and turnover, and staffing shortages, and compromises the quality of care and patient safety. This violence undermines providers’ ability to ensure safe, healing environments for all.”
    • “The AHA’s Hospitals Against Violence initiative includes resources and best practices for hospitals to use and share to address workplace and community violence.” 
  • Beckers Clinical Leadership relates,
    • “HHS Secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force, bringing the influential preventive care panel to 16 members.
    • “Mr. Kennedy made the appointments Sept. 17 through the Agency for Healthcare Research and Quality. The eight join eight members currently serving on the volunteer panel of prevention and evidence-based medicine experts.
    • “The task force carries outsized weight for health system and payer leaders: preventive services that the panel grades “A” or “B” must be covered by most private insurers without cost-sharing under the ACA. Its composition effectively shapes which screenings and preventive services patients can get at no cost.” * * *
    • “Seth Corey, MD, a pediatric hematologist-oncologist at Cleveland Clinic, will chair the task force. The other seven appointees are:
      • “Patrick Hunter, MD, a pediatrician at Pensacola (Fla.) Pediatrics and member of the Florida State Board of Medicine
      • “Ronald Karlsberg, MD, a clinical professor of medicine at Los Angeles-based Cedars-Sinai Medical Center’s Smidt Heart Institute
      • “Venkatesh Murthy, MD, PhD, professor of preventive cardiology at the University of Michigan in Ann Arbor
      • “Stephen Parente, PhD, a health finance professor at the University of Minnesota’s Carlson School of Management in Minneapolis
      • “Goldie Stands-Over-Bull, MD, lead family medicine physician at Texas Native Health in Dallas
      • “Louis Wilson, MD, a gastroenterologist and managing partner at Wichita Falls (Texas) Gastroenterology Associates
      • “Dennis Wulfeck, MD, a diagnostic radiologist and president of the practice board at Radiology Partners’ MBB Radiology in Jacksonville, Fla.” 
  • U.S. News and World Report tells us,
    • “The U.S. Senate ⁠health ⁠committee will hold a confirmation ⁠hearing next week for Dr. Heidi Overton, President Donald Trump’s pick to ​lead the embattled Food and Drug Administration, the panel said on Thursday.
    • “The hearing will take place ‌on September 24, the Senate Health, ‌Education, Labor, and Pensions Committee said in a statement. Trump nominated Overton, a White ⁠House policy aide, ⁠in August, turning to an “America First” ally to steady an agency ​shaken by staff losses, low morale and fights over vaccines, the abortion pill and drug approvals.
  • Per Department of Health and Human Services news releases,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today launched the new Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a major research effort to transform how autism is understood, diagnosed, and supported across the lifespan. SPECTRA will bring together biological, clinical, behavioral, and real-world data with advanced computational tools to enable earlier and more accurate diagnosis, identify factors that shape individual health and developmental trajectories, and develop more precise approaches to care tailored to each person’s needs.
    • “Autism is not one-size-fits-all, and our science and care cannot be either,” said HHS Secretary Robert F. Kennedy, Jr. “Millions of American families are impacted by autism, and they need better answers about why it presents so differently from one person to another and which approaches can best meet each person’s needs. SPECTRA will harness the best of American science and innovation to deliver those answers — and turn them into better outcomes for people with autism and their families.” * * *
    • “Learn more about SPECTRA on its program page, including information about the solicitation.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today issued a Request for Information (RFI) calling on Americans, scientists, physicians, industry, and public health experts to submit evidence and information on the potential health effects of electromagnetic fields (EMFs), radiofrequency (RF) radiation, and wireless radiation exposure.
    • “The RFI will help HHS evaluate the state of the science, compare U.S. and international safety standards and regulatory approaches, identify critical research gaps, and develop practical, evidence-based recommendations for policymakers, families, schools, communities, and public health professionals.
    • “Wireless technologies are part of daily life, and our science must keep pace,” said HHS Secretary Robert F. Kennedy, Jr. “The MAHA Strategy directed HHS to examine electromagnetic radiation and health research, and we are acting on that directive. I encourage scientists, physicians, industry, public health experts, workers, parents, and citizens to bring us the best available evidence so we can identify the gaps and focus federal research where it is needed most.” * * *
    • “More information about the RFI can be found at the Federal Register [PDF].”
  • The International Foundation of Employee Benefit Plans helpfully shares information about “Red Flags for Mental Health Parity Compliance Problems.”

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

  • FedSmith reports,
    • “Federal retirees and Social Security recipients are only one inflation report away from knowing their 2027 cost-of-living adjustment (COLA). The Bureau of Labor Statistics (BLS) will release the September inflation report on October 14. That report will provide all three CPI-W figures needed to calculate the 2027 COLA.”
    • “The latest estimate from The Senior Citizens League (TSCL) puts the 2027 Social Security COLA at 3.5%. The organization lowered its estimate from 3.6% after the latest inflation report.
    • “Because Social Security and Civil Service Retirement System (CSRS) benefits use the same underlying inflation measure, that estimate also indicates the COLA CSRS retirees may receive. For most Federal Employees Retirement System (FERS) retirees eligible for a COLA, however, a 3.5% increase in the CPI-W would result in a 2.5% FERS COLA because FERS uses a different formula.”
  • Serving those We Serve tells us what federal and Postal employees should know about the redesigned Social Security Statement.
  • Tammy Flanagan, writing in Govexec, lets us know how to navigate the Pay.gov maxe for federal retirement deposits.
    • “Don’t let missing service credits or opaque OPM billing notices shrink your monthly annuity. Here is what you need to know before clicking submit.”
  • MeritTalk informs us,
    • “The Office of Personnel Management (OPM) used governmentwide OneGov deals to give every employee access to six artificial intelligence (AI) platforms, and more than 70% of its workforce actively uses at least one, according to OPM CIO Adam Starr.
    • “Speaking Tuesday at the GovExec Government & AI Summit in Washington, D.C., Starr said OPM has leaned heavily on the General Services Administration’s (GSA) OneGov agreements to rapidly expand employee access to AI.
    • “The OneGov deals were key to our ability to innovate at OPM with AI,” Starr said. “We basically bought all of the AI offerings at $1, and so we gave every employee six AI tools, and we encourage them to use it.”
    • “Those tools include Google’s Gemini, Microsoft Copilot, xAI’s Grok, OpenAI’s ChatGPT, Anthropic’s Claude, and Perplexity AI, Starr said.
    • “The strategy is intentionally multi-model. Starr said he wants employees to have access to several platforms because AI models are evolving quickly and vendors are regularly “leapfrogging each other.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A., MPS IIIA is a rare inherited disease that progressively damages the brain and nervous system, causing children to lose cognitive, language and other developmental abilities over time. Until today, treatment was limited to managing symptoms; there was no FDA-approved therapy designed to change the underlying course of the disease.
    • “The Trump Administration is committed to bringing safe and effective treatments to patients with the most urgent and unmet needs. The approval of Fayuvi marks a historic moment for children and families living with MPS IIIA, which is a disease that has, until now, offered no approved treatment to alter its devastating course,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Gene therapy holds tremendous promise for rare diseases like Sanfilippo syndrome type A, and this milestone reflects the FDA’s commitment to action.”  
    • “Fayuvi is a one-time, intravenous (given directly into a vein) gene therapy that uses a modified, non-infectious virus called an adeno-associated virus serotype 9 (AAV9) to deliver a working copy of the SGSH gene into the patient’s cells. This enables the body’s cells to produce sulfamidase — the enzyme that is missing or deficient in MPS IIIA — allowing heparan sulfate to be properly broken down in lysosomes and reducing its harmful buildup throughout the body and brain.”
  • Targeted Oncology reports,
    • “FDA 510(k) clearance covers robotic colonoscopy for screening, surveillance, diagnostic evaluation, and advanced therapy including EMR and ESD across the full colon. 
    • “Triton 1 targets limitations of manual scope manipulation by adding robotic control intended to enhance stability, maneuverability, and procedural efficiency during flexible endoscopy. 
    • “CARE I (NCT06935734) reported 100% cecal intubation and no adverse events, meeting primary safety/efficacy end points in a first-in-human cohort. 
    • “Detection performance in CARE I included ADR 54.2% and polyp detection rate 67.5%, exceeding a cited 35% ADR industry threshold. 
    • “Endoscopist ergonomics improved, with a 67% lower perceived procedural workload versus manual colonoscopy on NASA-TLX, suggesting reduced physical and cognitive operator burden.”
  • MedTech Dive adds,
    • “Medtronic has received Food and Drug Administration clearance for a vessel-sealing technology used with its Hugo soft tissue robotic surgery system.
    • “The clearance, which Medtronic disclosed Wednesday, brings LigaSure technology, used in more than 45 million procedures worldwide, to the company’s robotic-assisted surgery platform.
    • “Targeting markets dominated by Intuitive, Medtronic has identified an opportunity to win share by pairing its platform with energy instruments that physicians use in non-robotic surgeries.”
  • MedPage Today informs us,
    • “Unapproved use of deoxycholic acid injection (Kybella) outside of the submental fat region may carry a risk of neuromuscular and other potentially serious adverse events, according to an FDA labeling update.
    • “A review of the FDA Adverse Event Reporting System (FAERS) revealed 129 cases of adverse events associated with use of deoxycholic acid in unapproved areas since the product was approved in 2015, the agency stated in a safety communication. The reports included some serious adverse events, such as blurred or reduced vision with periorbital use of deoxycholic acid injection and muscle or nerve injury, including facial paresis and paresthesia.
    • In announcing deoxycholic acid injection’s approval, the FDA emphasized, “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”

From the judicial front,

  • Bloomberg Law reports,
    • “An out-of-network healthcare provider can’t sue Cigna Health and Life Insurance Co. to recover more than $3 million it won against the plan through the No Surprises Act’s independent dispute resolution process, a federal appeals court said Thursday.
    • “The text and structure of the federal law, which created a process for resolving disputes between health plans and out-of-network providers, make clear that it doesn’t provide a private right of action to enforce arbitration awards obtained through that process, Judge Michael H. Park said. The US Court of Appeals for the Second Circuit thus affirmed the dismissal of East Coast Advanced Plastic Surgery LLC’s suit against Cigna.
    • “Although the NSA gives providers a right to payment from health plans for certain services, it delegates enforcement authority to multiple federal agencies and to states,” Park said for the unanimous panel. “This statutory scheme reflects Congress’s intent that the NSA, including payment of IDR awards, be enforced through administrative action rather than private litigation.”
  • Beckers ASC Review relates,
    • “San Tan Valley, Ariz.-based Rita Ntusa Anagho has been sentenced to 14 years in federal prison for orchestrating a $69 million Medicaid fraud scheme through her addiction treatment clinic, according to a Sept. 17 news release from the Department of Justice.
    • “Ms. Anagho, 54, a licensed nurse practitioner, owned and operated Tusa Integrated Clinic, which fraudulently billed Arizona’s Medicaid agency more than $69 million between about May 2022 and March 2023; the agency paid roughly $54.9 million on the false claims, according to court documents. 
    • “Ms. Anagho and her co-conspirators allegedly targeted patients covered under Arizona Medicaid’s American Indian Health Care Program, which reimburses at higher rates than other Medicaid plans, paid illegal kickbacks to sober home owners for patient referrals, and falsified treatment records to conceal the scheme.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “The U.S. cancer death rate declined 35% between 2015 and 2024, averting more than 4.8 million deaths, according to the American Association for Cancer Research’s 16th annual Cancer Progress Report, published Sept. 16.
    • Here are [three] things [the article has eight] healthcare leaders need to know from the report:
    • Death rates fell an average of 4.2% per year for lung cancer, 1.3% for colorectal cancer and 1.2% for female breast cancer between 2015 and 2024.
    • An estimated 2.1 million new cancer cases will be diagnosed in 2026.
    • By 2050, the number of annual cancer diagnoses is projected to rise to 2.5 million.
    • More than 18.6 million people with a history of cancer were living in the U.S. as of Jan. 1, 2025.
    • AACR researchers expect 22 million people to be living with cancer or a history of cancer by 2035.
    • “Read the full report here.”
  • Healio points out,
    • “Around 2.71 billion people worldwide were exposed to secondhand smoke in 2023.
    • “An expert encouraged clinicians to screen women, children and patients with cardiac issues for exposure.” * * *
    • “Despite the findings, Flor and colleagues highlighted progress from tobacco-reducing policies in the Americas, as “of the 79 countries attaining the highest level of achievement in smoke-free protections globally, 24 are in the Americas, approximately 70% of the countries in that region.”
  • STAT News adds,
    • “For years, researchers have known that, among people diagnosed with lung cancer, the prevalence of nonsmokers has been increasing. But they have been trying to determine what factors — whether genetic, environmental, or something else — might put these “never-smokers” at heightened risk. 
    • “Now, researchers have identified a very rare genetic variant that is associated with 25-fold higher odds of lung cancer, they reported in the journal Science on Thursday. In the U.S., the variant is far more common among people in Southern Appalachia than in other regions. 
    • Experts said that the variant likely only plays a role in a small portion of never-smoker lung cancer cases. But the research provides further evidence that these types of tumors can be tied to distinct risk factors, which may in turn require thinking differently about screening programs and treatment strategies. More broadly, the new study highlights the types of narrow but crucial discoveries that can be made by turning to large datasets replete with health information from millions of people. In this case, the investigators relied on genetic data from 23andMe.” * * *
    • “The variant in question — known as T790M — is a version of a gene called EGFR, which typically helps regulate how cells grow and divide. Select EGFR mutations can crop up over a person’s life and are among the most important drivers of lung cancer, and in turn are targeted by some cancer drugs.”
  • The Washington Post calls attention to “5 movements physical therapists say every adult over 50 should do daily.”
    • These simple moves can help you maintain mobility and independence as you age.”
  • Beckers Behavioral Health informs us,
    • “A 13-item Mental Wellness Tool detected common or severe mental disorders, substance use disorders and suicide risk among patients receiving psychiatric emergency department care at a New York City hospital, according to a Sept. 17 Medscape report.
    • “Existing mental health screening tools typically assess for one disorder, and screening for a range of psychiatric conditions can take well over 45 minutes and require several assessment tools. The mwTool-13 is designed to screen for multiple conditions in a single assessment.
    • “The mwTool-13 can be administered in 2 to 10 minutes, according to a Sept. 3 study published in Psychiatric Services.”
  • The Wall Street Journal shares readers views on patient portals.
  • Health Day tells us,
    • “Nearly two-thirds of suspected poisonings in young children probably do not need the emergency department and can be handled by a call to the local poison control center, according to a study published in the August issue of Clinical Toxicology.
    • “Liam P. McLoughlin, M.D., from Rutgers New Jersey Medical School in Newark, and colleagues investigated the medical necessity of pediatric emergency department presentations for poison cases where a poison control center was not contacted prior to presenting at the emergency department. The analysis included toxicologist reviews of summaries from 348 poison control center cases, originating from a health care facility, involving patients aged younger than 6 years.” * * *
    • “A big takeaway from the paper is that more needs to be done to make sure parents, schools, and communities know the poison center is a resource they can turn to when a poisoning is suspected,” McLoughlin said in a statement. “The poison center is available 24/7, 365, and is staffed by amazing people who can provide life-saving information by phone at no cost.”
  • and
    • “Exercise is already recommended to help people with cancer manage fatigue and improve quality of life. Now, there is evidence the benefits may go further.
    • “A new study finds structured exercise may help people with cancer live longer and have more time free of disease.
    • “Chih-Chen Tzang of the National Taiwan University and colleagues analyzed 21 clinical trials involving more than 8,400 cancer patients.
    • “Some followed supervised exercise programs that included aerobic exercise, strength training or both. Others did not.
    • “Over an average follow-up of about five years, those who exercised were 23% less likely to die and 17% less likely to have their cancer return before death.
    • “The benefits were strongest among people with early-stage cancer, those who did aerobic exercise — alone or with strength training — and those who completed at least 70% of their exercise program.”
  • Per Genetic Engineering and Biotechnology News,
    • “The genome editing toolbox provides unprecedented opportunities to engineer the human genome. However, genome editing for therapeutic benefit continues to have its limitations. Most current methods rely on untargeted gene delivery or short DNA edits that need to be individualized to each patient.
    • “Now, a new paper describes a novel genome engineering method, prime assembly, that allows long DNA fragments to be integrated into precise and programmable target positions within living cells. This approach, which leverages CRISPR-targeted dual flap synthesis, may allow for the development of universal gene therapies.
    • “This work is published in Nature in the paper, “Targeted genomic integration and rearrangement using prime assembly.”
  • Per Fierce Pharma,
    • “Roche’s T-cell engager portfolio has notched another milestone, as a phase 3 trial of the company’s Lunsumio met its primary endpoint in earlier-line follicular lymphoma.
    • “Without sharing any specific data, Roche and its subsidiary Genentech said Lunsumio’s combination with lenalidomide (Revlimid) demonstrated a statistically and clinically meaningful improvement in progression-free survival against rituximab (Rituxan) plus lenalidomide, known as R2, in the phase 3 Celestimo study. 
    • “The trial enrolled follicular lymphoma (FL) patients who have received at least one prior line of treatment, and it serves as the confirmatory study required to convert Lunsumio’s existing accelerated approval as a monotherapy in third-line FL into a full approval, while also potentially moving the drug earlier into the second-line setting.”

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

  • Beckers Payer Issues reports,
    • “The National Committee for Quality Assurance has named the highest quality and most effective health plans of 2026 based on clinical quality, patient experience and health plan accreditation status.
    • “The ratings were released Sept. 16 and are based on 2025 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover approximately 236 million people. Some MA plan data is from 2024 because of reporting schedules, and NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 956 plans received a rating.
    • “Commercial plans that received a five-star rating:
      • BCBS Massachusetts
      • Capital District Physicians’ Health Plan (New York)
      • Capital District Physicians’ Healthcare Network (New York)
      • Harvard Pilgrim Health Care (Massachusetts, Maine)
      • Independent Health (New York)
      • Kaiser Mid-Atlantic (Washington, D.C.; Maryland; Virginia)
      • Kaiser Northern California
      • UPMC Benefit Management Services
      • UPMC Health Plan
  • and
    • “When Providence announced it was shutting down its health plan earlier this year after a $102 million loss in 2025, it joined a growing list of health systems stepping back from the insurance business. Carle Health’s Health Alliance, Michigan Medicine’s U-M Health Plan and others have wound down or are exiting, citing volatility in Medicare Advantage and government payer markets that have made provider-sponsored plans increasingly difficult to sustain.
    • “Terry Gilliland, MD, president and CEO of Danville, Pa.-based Geisinger, is watching the same environment unfold and coming to the opposite conclusion.
    • “Rather than say, this is hard and dump the plan, we’ve made the necessary changes including leadership top to bottom to grow profitably,” Dr. Gilliland said.”
  • and
    • “CVS Health’s Aetna is expanding prior authorization bundles for cancer, available to some Medicaid members as of Sept. 1.
    • “The update impacts Medicaid members with providers in Oklahoma, Illinois, Maryland, New Jersey, Virginia, Florida, Kentucky and West Virginia who use the Eviti portal for prior authorizations. Aetna anticipates broadening eligibility to Medicare and commercial members in the first half of 2027.
    • “According to a Sept. 17 news release, Aetna observed providers submitting four different prior authorizations, on average, for its members needing cancer treatments. These bundles allow a single prior authorization request that could encapsulate medical oncology and radiation oncology services with high-tech imaging needs. The expansion builds upon an early rollout of the bundles. 
    • “By approving a broader set of treatments and related services upfront, we’re removing barriers that can delay care,” Aetna COO and Medicaid President Katerina Guerraz said.”
  • Beckers Hospital Review relates,
    • “St. Louis-based Ascension has reached an agreement to transfer full ownership of its co-owned Arizona managed care health plan, Mercy Care, to CVS Health subsidiary Aetna, a spokesperson for Ascension confirmed with Becker’s. 
    • “Ascension co-owns the plan with San Francisco-based CommonSpirit’s Dignity Health, the spokesperson confirmed. The agreement is subject to regulatory reviews and approvals.
    • “Mercy Care has long served vulnerable populations, families and individuals across Arizona through Arizona Health Care Cost Containment System Medicaid programs and Medicare Duals Special Needs Plans,” the spokesperson said. “Aetna has successfully managed Mercy Care’s day-to-day operations and administrative services for over 20 years.”
  • and
    • “HCA Healthcare CFO Mike Marks said payers have outpaced hospitals on AI-driven claims processing, adding another layer to the friction hospitals face on denials, underpayments and prior authorization.
    • “I know there’s a lot of talk about AI in the hospital revenue cycle, we’re behind the payers, in my view,” Mr. Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference in Nashville, Tenn., where the 190-hospital system is also headquartered.
    • “Payers, he said, have real incentives driving their AI investments, including medical loss ratios and patient populations to manage.
    • “They’ve been working really hard on their version of AI in their claims shop,” he said.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare is seeing softer elective surgery volumes as patients lose coverage through the health insurance exchanges, with broader affordability pressures potentially contributing to the slowdown, CFO Mike Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference.
    • “The 189-hospital, for-profit system continues to see strong overall demand for healthcare services, but the movement of patients from exchange coverage to uninsured status is weighing on elective procedures.
    • “On the inpatient side of elective, and frankly, on the outpatient surgery side as well, the biggest issue is HICS,” Mr. Marks said, referring to health insurance exchange coverage. “This movement out of HICS to uninsured — as people in our communities have lost coverage on the exchange [and] become uninsured — they generally lose access to elective care. That is the primary driver of the slowdown in our elective surgery volumes is exchanges.”
  • Beckers ASC Review tells us,
    • “Brentwood, Tenn.-based Surgery Partners has completed the sale of its ownership interests in its Idaho Falls, Idaho, facilities to Intermountain Health for $797 million in gross proceeds, according to a Sept. 17 news release.
    • “The deal includes Mountain View Hospital and Idaho Falls Community Hospital, values the combined facilities at about $1.15 billion, and delivered Surgery Partners $587 million in net cash proceeds at closing, subject to customary post-closing adjustments. Physician ownership of Mountain View Hospital will remain unchanged under Intermountain’s leadership, and the proceeds will primarily go toward paying down debt, which is expected to improve the company’s balance sheet leverage by about 30 basis points from 4.4x at the end of the second quarter.
    • “Excluding the Idaho Falls facilities, Surgery Partners expects a 50% reduction in its Medicaid payor mix, to under 2% of revenue, along with the elimination of its neonatology, obstetrics, inpatient pediatrics and retail and compounding pharmacy service lines.”
  • Fierce Healthcare informs us,
    • “Big box retailer Walmart is launching a six-month pilot program that places pharmacists in a new “Health Ambassador” role at five rural stores to help customers navigate health and wellness resources.
    • “Walmart’s Health Ambassador Associate will be able to aid patients in understanding their health goals and help connect them to relevant services and resources.
    • “The Health Ambassador role will be piloted at locations serving rural and underserved communities across the U.S., including in Lexington, Tenn.; Caro, Mich.; Franklin, Va.; Fort Scott, Kan.; and Searcy, Ark.
    • “The pilot will initially focus on three healthcare areas: diabetes, weight management and maternal health. Health Ambassadors can also aid customers in nutrition, movement, sleep and stress management through the program’s in-person conversations and tailored coaching.”
  • and
    • “Humana researchers found that cancer patients who received specialty pharmacy care coordination services had fewer hospitalizations and emergency department visits, along with lower medical costs.
    • “The study, conducted by Humana Pharmacy Analytics and Consulting, analyzed health outcomes for people with cancer who are Humana Medicare Advantage members with Part D prescription plan coverage and who received medication adherence care coordination guidance, as compared to those who opted out of coordination. 
    • “Humana’s CenterWell Specialty Pharmacy Oncology Center of Excellence (COE) provided the care coordination services over the course of one year. That COE program provides specialized, personalized clinical care and mail-order delivery for patients managing complex cancer diagnoses and therapies. Within CenterWell, Humana’s health care services organization, CenterWell Pharmacy serves many Humana members as a mail-order pharmacy and also serves patients who are not enrolled in a Humana plan.”
  • and
    • “Blue Shield of California announced Thursday that it plans to expand its Virtual Blue program, doubling program enrollment for members.
    • “Beginning in January 2027, the benefit will be included in fully insured preferred provider organization (PPO) plans for employers with 101 to 3,000 employees, as well as for certain individual and family plans, the insurer said.
    • “The expansion will allow an additional 200,000 mid-size employer PPO members and 60,000 individual and family plan members to utilize the program, increasing its total enrollment to more than 410,000 participants, executives say.
    • The virtual-first program, first launched in 2023 in collaboration with Accolade and TeleMed2U, has more than 150,000 members as of April. The program gives members access to a range of virtual health services at no additional cost, along with care from providers in Blue Shield’s PPO network.
  • Per BioPharma Dive,
    • “Novo is investing in oral biologics, signing a deal with fellow Danish company Orbis Medicines to discover multiple “macrocycles” that have the “potential to replace injectable medicines,” Orbis said Thursday.
    • “Orbis could receive as much as $1.4 billion in up front and downstream payouts, as well as sales royalties, in the deal. The companies didn’t specify the number of drugs on which they would collaborate, nor specific diseases, only mentioning that they’ll pursue unnamed cardiometabolic targets.
    • “The use of macrocycles is one way Novo could overcome some of the limitations of standard oral peptide medicines, such as poor digestive absorption. The highest dose of Novo’s Wegovy pill contains 20 times the highest injectable dose because most of the drug’s active ingredient is chewed up before reaching the bloodstream.”
  • and
    • “North Immunology, in the early stages of developing a potential competitor for the widely popular inflammatory disease drug Dupixent, plans to go public next year via a reverse merger with Aethlon Medical.
    • “After the merger, the companies expect North Immunology investors to own 95.25% of the new entity, with the rest going to Aethlon shareholders. Those who own Aethlon stock immediately prior to the merger will also get a contingent value right entitling them to potential proceeds from Aethlon’s legacy Hemopurifier business. 
    • “The new company will operate as North Immunology and trade on the Nasdaq under the ticker symbol “NRTX,” Aethlon said Thursday. North Immunology’s executives will lead the combined entity, and its directors will populate the board, along with some new independent directors. The companies expect the transaction to close in the first quarter of 2027.”
  • Healthcare Dive points out,
    • “Healthcare organizations are rapidly adopting agentic artificial intelligence, but governance frameworks for managing the technology are not evolving at the same pace, according to a new survey from digital identity security firm Imprivata.
    • “More than 85% of leaders responsible for AI strategy at healthcare organizations say they’re confident they have visibility into AI agent activity and are able to fully control and govern an autonomous agent’s actions.
    • “However, 72% of respondents admit AI tools are deployed without IT approval at least occasionally within their organizations, highlighting a disconnect between confidence and reality.”

Midweek report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, D.C.,

  • STAT News reports,
    • “Normally, discussions about how congressional advisers study Medicare spending are quite dry. Not so at the House Ways and Means Committee on Wednesday.
    • “In a party line vote, committee Republicans pushed forward a bill that seeks to change how the Medicare Payment Advisory Commission studies Medicare Advantage spending. In particular, this bill would direct the nonpartisan agency to study the topic of overpayments to Medicare Advantage plans in a manner that’s more favorable to insurers.” * * *
    • “It’s a bit of a change in tune for some Republicans, especially those who are doctors, who had become frustrated with Medicare Advantage insurers that deny care to patients. 
    • “However, Rep. Greg Murphy (R-N.C.), who is among those doctors who have criticized certain industry practices, said he had no problem supporting the bill. 
    • “Asking for more information so that we can make real choices and reform the Medicare Advantage system, I am absolutely for,” he said.”
  • and
    • “Democrats are vowing to aggressively pursue oversight if they win control of either the House or Senate in November’s midterm elections. Health care issues, including President Trump’s drug pricing deals, are potential targets. 
    • “It’s common for parties to turn to oversight when they take control of a congressional chamber. Lawmakers can use oversight to tell a story about the other side. It also avoids intraparty divisions by focusing attention on what the other party has done. And if Democrats want to keep the focus on Trump, even though he can’t run again, oversight is a good way to do that.”
  • MedPage Today adds,
    • “Nicole Saphier, MD, President Donald Trump’s third surgeon general nominee, was grilled at her confirmation hearing Wednesday about her stance on childhood vaccines, voicing support for immunization as she seeks to serve in an administration that has moved to make sweeping changes to vaccine guidance.
    • Saphier, a radiologist and former Fox News Channel contributor, faced tough questioning about her views on the safety of childhood vaccines by Sen. Bill Cassidy, MD (R-La.), who pressed her to declare whether she believed there was a link between vaccines and autism — which widespread scientific consensus has concluded doesn’t exist, yet which the Trump administration has repeatedly pushed to revisit.
    • “I do not believe childhood vaccines cause autism,” Saphier said. She also said “the MMR [measles, mumps, and rubella] vaccine is our greatest tool for combating measles,” in response to a question by Cassidy over whether parents should give children that shot, and which the president recently ordered be spaced out.
  • Healthcare Dive relates,
    • “Health plans are generally performing better on quality and performance ratings, though nonprofit insurers continue to surge past their for-profit peers.
    • “The National Committee for Quality Assurance released its 2026 ratings on Tuesday, which score commercial, Medicare and Medicaid plans across a range of measures of clinical quality, patient experience and health outcomes. Eighteen plans nabbed the standards organization’s highest 5-star rating, up from 11 last year. All of them are nonprofits.
    • “Of the major publicly traded carriers, CVS had the highest scores, averaging at about 4 stars, according to a Healthcare Dive analysis of the data. Meanwhile, plans’ average rating ticked up slightly, from 3.483 last year to 3.493 in 2026 thanks to improvements in commercial and Medicaid plans, though Medicare insurers’ average rating slipped.”
  • Healthcare Finance News tells us
    • “The American Hospital Association and American Medical Association are urging the Centers for Medicare & Medicaid Services to reconsider proposed reductions to Medicare physician payments for 2027, warning that the cuts could threaten patient access and the financial stability of physician practices.
    • “Comments on the proposed rule, which was released in July, were due Monday.
    • “The AMA voiced its concerns earlier this month about a CMS plan to cut physician pay when doctors provide a separately identifiable office or outpatient evaluation and management (E/M) visit on the same day as most procedures are performed. 
    • “The agency scrapped this same plan eight years ago, the AMA said, after physicians and other stakeholders raised serious concerns. 
    • “But CMS is pitching a similar idea in its 2027 Medicare physician payment schedule proposed rule,” the AMA said. “If finalized, most changes, including this one, would be scheduled to take effect Jan. 1.”
    • “The AMA called for annual physician payment updates tied to medical inflation, arguing that the lack of consistent inflationary adjustments has contributed to the erosion of physician practice sustainability.”
  • The American Hospital Association News tells us,
    • “The Workgroup for Electronic Data Interchange has launched its fall 2026 survey to assess industry readiness for the Centers for Medicare & Medicaid Services’ interoperability and prior authorization final rule. Survey responses are anonymous, and all results are aggregated. The survey will close on Oct. 9. WEDI plans to use the results to make recommendations to CMS, inform stakeholders and assist WEDI in its development of industry guidance and education.” 

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

  • Govexec reports,
    • “Senate Democrats again urged the Trump administration Wednesday to abandon its plans to collect detailed health information from federal workers, retirees and their families, saying recent tweaks to “de-identify” records are insufficient to protect employees’ privacy.
    • “Last December, the Office of Personnel Management published an information collection request in the Federal Register that would require insurers who participate in the Federal Employees Health Benefits and Postal Service Health Benefits programs to provide monthly reports with identifiable health data on their enrollees.
    • “Following pushback from federal employee groups and medical ethicists, OPM in June revised its proposal, purporting to take steps to mask employees and retirees’ identities in the data collection. But organizations that represent federal workers and retirees warned that the agency still hadn’t done enough to protect patients’ privacy.
    • “In a letter to OPM Director Scott Kupor, a group of six Senate Democrats, led by Sens. Adam Schiff, D-Calif., and Mark Warner, D-Va., who previously requested the proposal’s withdrawal, wrote that the proposed pseudonymization of records does not their “fundamental” concerns with the plan, particularly the agency’s insistence that it may re-identify insurance claimants in the future.”
  • FedWeek relates,
    • “OPM has provided some additional information on agency responsibilities to conduct the annual survey of federal employees—which it plans to shift to them from itself under a pending rules proposal—although still not setting a schedule for conducting this year’s version.
    • “A September 17 Federal Register notice states that the survey traditionally called the Federal Employee Viewpoint Survey will be renamed as the Annual Employee Survey, and reaffirms the intention in the earlier rules proposal to reduce the number of core questions from 16 to 10.
    • “That is to include dropping longstanding questions asking employees about their overall level of satisfaction with their job; with the recognition they receive for doing good work; with their organization overall; with the information they receive about what is going on in it; with their level of involvement with decisions that affect their work; and whether they would recommend their organization as a good place to work.
    • “OPM traditionally used those satisfaction-related questions in creating an index that was widely—although not officially—seen as a proxy for morale.”

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

  • Good Housekeeping reports,
    • “FDA issued a Class II recall on September 11 for six hand soap products from Intercon Chemical Co. distributed across 15 states. The original recall happened on June 29 due to potential bacterial contamination.
    • “Two soap variants contained harmful bacteria including Pseudomonas aeruginosa and Serratia marcescens, which can cause serious infections like pneumonia, UTIs, and blood infections, especially in immunocompromised individuals.
    • “Consumers should identify recalled products by UPC codes and lot numbers listed for Intercon, Clearly Better, Summit, Vestis, and Laura Lynn brands, then stop use immediately and seek medical attention if symptoms develop.”
  • Radiology Business relates,
    • “The U.S. Food and Drug Administration has approved a new generic radiopharmaceutical alternative from drugmaker Curium, aimed at competing with another treatment on the market. 
    • “Bexlutry (lutetium Lu 177 dotatate) is a radioligand therapy designed to deliver targeted radiation for treating a group of rare cancers originating in the digestive track and pancreas. Boston-based Curium scored the approval through the FDA’s 505(b)(2) pathway, supported by published evidence and targeted bridging data. 
    • “This demonstrated that Bexlutry achieved a similar biological and chemical profile to the previously approved Lutathera, manufactured by rival firm Novartis. 
    • “Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer,” Mike Patterson, Curium’s CEO of North America, said in a statement Sept. 14. “Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy.”

No Surprises Act News

  • Politico reports,
    • “A Senate committee held stakeholder roundtables on Tuesday to discuss reforms to the 2020 No Surprises Act, which set up how doctors and insurers are paid for unexpected medical bills, Simon reports.
    • “The act, originally co-sponsored by Health, Education, Labor and Pensions Chair Bill Cassidy, shielded patients from unexpected out-of-network emergency care bills. But it has come under fire for creating a case backlog in a system that critics argue can pay disproportionately in favor of doctors.
    • “Employers, physicians, insurers and unions — groups typically at odds — held a cordial, constructive talk about possible solutions, according to four people familiar with the meetings who were granted anonymity to speak candidly. Committee staff also met separately with the arbitrators responsible for overseeing and resolving payment disputes.
    • “Over three hours, the stakeholder group didn’t settle on any policy changes, but they agreed on the need to eliminate the dispute backlog by filtering out ineligible claims and encouraging faster payouts. The group emphasized the importance of benchmark rates for medical services, known as qualified payment amounts, when determining payouts and that only emergency care bills should be eligible for arbitration.
    • “It is early, and the devil will be in the details, so to speak, as conversations continue, but overall a positive vibe,” said one of the four people familiar with the discussion. Another of the four, who was a provider attendee, said, “It was pointed but respectful.” * * *
    • “What’s next: The Senate HELP Committee will hold a roundtable with members next week to talk through legislative solutions.”

From the judicial front,

  • Healthcare Dive reports,
    • “A group of independent pharmacies in Arkansas are suing Express Scripts, one of the largest pharmaceutical middlemen in the U.S., for allegedly underpaying for tens of thousands of prescriptions.
    • “The lawsuit filed Tuesday, which seeks hundreds of millions of dollars in damages, is the first filed under a state law passed last year giving Arkansas pharmacies the ability to go after PBMs for reimbursing them below the acquisition cost of drugs, according to lawyers for the plaintiffs.
    • “We’re committed to reimbursing pharmacies at competitive rates and will defend ourselves against these allegations,” an Express Scripts spokesperson said.

From the public health and medical / Rx research front,

  • The New York Times offers advice on whether you are eating enough fiber in your diet.
    • “With so much attention on protein lately, you’d be forgiven for forgetting about fiber.
    • “But if you’re like most adults in the United States, you’re probably falling short of the recommended minimum of 21 to 38 grams per day, depending on your age and sex. The average U.S. woman consumes about 15 grams of fiber daily, and men consume about 18 grams per day.
    • “Closing that gap may be one of the best strategies for improving your health. Fiber nourishes gut microbes, lowers blood pressure and cholesterol, improves digestion and reduces the risks of heart disease, Type 2 diabetes and certain cancers.
    • “It can seem like a big challenge to eat enough fiber, but nutrition experts say it doesn’t have to be. You just have to know where to look.”
  • Cardiovascular Business adds,
    • “Eating four to six servings of whole-grain foods per day is associated with multiple cardiovascular benefits, according to a new meta-analysis published in European Heart Journal. 
    • “The authors focused on data from more than 6,500 adults from the United States, Europe, Asia, Canada, Australia or Brazil who participated in one of 87 different clinical trials. Overall, eating 48 grams of whole-grain food—oats, brown rice or quinoa, for example—each day was associated with improvements in body weight, waist circumference, total cholesterol, blood pressure, LDL cholesterol, glucose and interleukin-6 levels. These are all known risk factors of cardiovascular disease.
    • “This is the largest and most comprehensive meta-analysis of randomized controlled trials on whole grain intake and cardiovascular risk factors,” senior author Helda Tutunchi, PhD, a nutrition specialist with Tabriz University of Medical Sciences in Iran, explained in a statement. “Unlike previous reviews, we looked specifically at how much whole grain people need to eat to get the greatest benefits. We also evaluated the certainty of the evidence and found high-certainty evidence for improvements in several outcomes, including body weight, waist circumference and total cholesterol.”
    • “Tutunchi added the impact of eating more whole-grain foods appears to be through “several modest improvements acting together” as opposed to “one large effect on a single risk factor.”
  • Health Day relates,
    • “Women’s risk of having a harmless tumor caught and treated as a result of breast cancer screening is much lower than once thought, a new evidence review has concluded.
    • “Overdiagnosis — the detection of breast cancers that never would have harmed a woman’s health during her life — occurs in fewer than 5% of cancer screenings, researchers reported Sept. 14 in the Journal of the National Cancer Institute.
    • “That’s far lower than previous estimates, which held that as many as 30% to 50% of breast cancer detected through screening might represent overdiagnosis, researchers said.
    • “These earlier studies were inaccurate because they tracked breast cancer screenings for a limited period of time, the research team argued.”
  • and
    • “ADHD is linked to a nearly 50% increase in GI problems, a new evidence review says.
    • The association was even stronger for specific GI problems, including an almost doubled risk of constipation, a 58% increase in irritable bowel syndrome and more than four times higher odds of losing bowel control, researchers reported Sept. 10 in the Journal of Attention Disorders.
    • “Almost every gut symptom we looked at: constipation, IBS, even indigestion, appeared to be associated with ADHD,” said lead researcher Sarah Blake, a medical student at the University of Warwick Medical School in the U.K.
    • “These symptoms can have a real impact on daily life, but they could easily be overlooked if the focus is on ADHD itself,” she added in a news release.
    • “There are several potential explanations for these links, including ADHD-related eating patterns, side effects from medication and even ties between ADHD and gut bacteria, researchers said.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Scientists studying Alzheimer’s disease have long focused on genes, proteins, and cells, but one class of molecules has remained largely outside the playbook: microproteins. These small proteins, produced from small open reading frames (ORFs) and typically measuring 150 amino acids or fewer, have been difficult to detect and study. Yet growing evidence suggests they may have important roles in health and disease.
    • “Now, researchers at the Salk Institute have created what they describe as the first microprotein atlas of the human frontal cortex with and without Alzheimer’s disease. The study, “A microprotein atlas of the human frontal cortex in Alzheimer’s disease,” was published in Nature Aging. The resource integrates transcriptomics, mass spectrometry, and deep-learning-predicted spectra across postmortem brain samples to identify microproteins that have been overlooked in standard protein catalogs.
    • “We still do not fully understand the molecular mechanisms of healthy aging, and that is especially true for microproteins, which have been inadvertently overlooked for decades,” said senior and co-corresponding author Alan Saghatelian, PhD, professor and the Dr. Frederik Paulsen Chair at Salk, in a press release. “Our atlas allows scientists to systemically investigate microproteins in aging and neurodegeneration, which should bring us closer to understanding and tackling diseases like Alzheimer’s or Parkinson’s.”
  • 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 tavapadon (AbbVie Inc.) for Parkinson’s Disease.
    • “Downloads: Evidence Report | Voting Questions | Public Comments | Response to Public Comments
    • “Parkinson’s disease is a chronic and progressive neurological condition largely characterized by the loss of motor skills and physical function,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “There are currently no disease-modifying treatments, so symptom management is paramount. While tavapadon provides some relief from key symptoms, benefits were similar to those of older, generic drugs, and discontinuation from tavapadon due to adverse events was relatively high. The combination of modest benefit and uncertainties around discontinuation raise important questions about tavapadon’s long-term value.”
    • Register here to watch the live webcast of the October 1st ICER public meeting.

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

  • Beckers Hospital Review reports,
    • St. Louis-based Ascension narrowed its operating loss by $371 million in fiscal 2026, as stronger revenue, higher patient volumes and operational improvements moved the health system closer to breakeven, according to financial documents published Sept. 16.
  • and
    • “Fitch revised Chicago-based CommonSpirit Health’s rating outlook to negative from stable on Sept. 16, while affirming the health system’s “A-” rating. 
    • “The revision follows CommonSpirit’s financial results through the quarter ended March 31, which fell short of management’s internal margin targets, Fitch said in a Sept. 16 report. Fitch pointed to an uneven path to sustained profitability as the system executes several overlapping initiatives at once, including an Epic EHR rollout, insourcing revenue cycle operations and its multiphase Project Impact plan, which targets an 8% EBITDA margin by fiscal 2029.” 
  • Beckers Behavioral Health relates,
    • “U.S. News & World Report named 50 hospitals to its 2026-2027 Best Children’s Hospitals Pediatric & Adolescent Behavioral Health list.
    • “U.S. News evaluated 91 hospitals for their care of children and teens with mental and behavioral health conditions, including autism, anxiety, depression, eating disorders, ADHD, bipolar disorder, schizophrenia, language and learning disorders, and substance abuse and addiction.
    • “Programs and care in areas such as medication screening and safety, speed and efficiency of the emergency department, and management of side effects were among the factors used to rank hospitals.”
  • Beckers Payer Issues tells us,
    • “SCAN Health Plan has emerged as a major Medicare Advantage partner for retailers, with Walmart now partaking in a co-branded plan.
    • “The health insurer and retailer are launching the plan in two states, according to a Sept. 16 SCAN news release. More than 2 million enrollees are expected to have access.
    • “The MA offering could tie in pharmacy and vision services, food, and over-the-counter benefits, pending regulatory approval. The news release also said Walmart will leverage Everyday Health Signals, its AI-driven platform for tailored nutrition and wellness, in the collaboration.
    • “What makes this collaboration unique is Walmart’s role in customers’ everyday lives. Because customers regularly turn to Walmart for groceries and other everyday essentials, we have an opportunity for those who choose to participate, to use insights from their shopping experiences to make nutrition guidance more relevant and actionable,” said Pravene Nath, MD, group director for consumer health and data solutions at Walmart U.S.” * * *
    • “In August, SCAN announced plans to roll out insurance products with Costco, as well.” 
  • Beckers Physician Leadership shares the new math of physician independence.
    • “Independent physicians have spent more than a decade watching the share of their peers who own their own practices shrink. 
    • “New data exists that tells the story of what it now costs to stay independent, how much deal-making and closure activity is still working against that choice, and where regulators and a new wave of physician-owned infrastructure are starting to push back.
    • “Taken together, the figures describe less a single trend than a recalculated equation — one where the cost of going it alone, the cost of selling and a growing set of options in between are all moving at once.”
  • MedCity News informs us,
    • “Thatch, a health benefits platform, announced on Tuesday that it raised $108 million in funding, reaching a $1 billion valuation.
    • “Thatch helps employers offer Individual Coverage Health Reimbursement Arrangements (ICHRAs) — which recently rebranded as CHOICE Arrangements — in which employers can provide their employees tax-free money so they can purchase their own individual health insurance plans. Employees can also use the funds for certain healthcare expenses, including GLP-1s and therapy. More than 5,000 employers use the company, including Jersey Mike’s and Smoothie King. 
    • “The Series C funding round was from The General Partnership, Index Ventures, General Catalyst and Andreessen Horowitz. ADP Ventures, Paychex, Eli Lilly and Company, Scale Venture Partners, QuantumLight, SemperVirens, Quiet Capital and Avid Ventures also participated. In total, Thatch has raised $192.5 million in equity funding.”
  • Fierce Healthcare adds,
    • “Ayble Health secured a $16 million oversubscribed series A funding round to accelerate its expansion into artificial intelligence-driven precision digestive and autoimmune healthcare.
    • “Neon led the funding round, with participation from Unum Ventures, Upfront Ventures, M13, Cleveland Clinic Ventures, DigiTx, Accomplice and several individual investors. 
    • “I’ve been tracking the GI space closely for years, and what Ayble has built is different,” said Kimmy Scotti, Neon founding and managing partner, in a statement. “Having invested early in top digital health companies, I’ve seen what it takes to build a category-defining company in healthcare. Ayble has spent years building the clinical evidence before they scaled the business. That earns trust from the full ecosystem: health systems, payers, and most importantly, patients, and it’s what makes a durable market leader.”
  • BioPharma Dive points out,
    • “Novartis will pay $125 million up front for rights to a delivery platform designed to get drugs into the brain.
    • “Sironax, a Boston-area biotechnology company, said Tuesday that Novartis has exercised an option to acquire full ownership of that startup’s brain delivery platform. Sironax’s technology is meant to overcome a major challenge in neurological drug development: delivering therapeutics across the “blood-brain barrier.”
    • “Sironax will receive the nine-figure payout following the close of the transaction and will continue to retain rights to develop, manufacture, and commercialize certain assets with the platform. The company currently has three programs in early-stage trials that it plans to move forward using the purchase proceeds.”
  • Cardiovascular Business notes,
    • “Jaguar LAA, a new California-based medtech startup, has purchased key assets related to performing left atrial appendage (LAA) closure procedures from Johnson & Johnson. 
    • “Johnson & Johnson has owned these assets since it acquired the medtech company Laminar for $400 million back in 2023. Now, some original Laminar employees have partnered with investment firm Santé Ventures to buy back the assets and push forward as Jaguar LAA, a brand new company.
    • “The financial terms of this acquisition have not yet been made public.” 
  • The Wall Street Journal lets us know,
    • “Novo Nordisk NOVO.B, the Danish drugmaker behind blockbuster diabetes and weight-loss drugs Ozempic and Wegovy, is partnering with Anthropic to use artificial intelligence for drug research.
    • “Novo said Wednesday it would use Anthropic’s science-specific platform, known as Claude Science, to help speed up the discovery and development of new medicines and strengthen the pharmaceutical company’s software development.
    • “The partnership is the latest by a slate of major drugmakers, including Eli Lilly, Merck and Roche, that are placing big bets that AI can help them discover and produce medicines more quickly. 
    • “AI can help us increase productivity in R&D and compress the path from research to marketed product. But beyond this, AI tools can also offer completely new scientific opportunities and aid reasoning and understanding of human biology and drug mechanics,” Novo Chief Executive Mike Doustdar said.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Energy and Commerce Subcommittee on Health held a hearing Sept. 15 to discuss more than a dozen legislative proposals regarding Medicare provider payment and healthcare cybersecurity. The AHA provided comments to the subcommittee on bills designed to improve long-term physician payments, including proposals to increase the budget neutrality threshold in the Medicare physician fee schedule and a bill to replace the Merit-based Incentive Payment System with the Data-driven Performance Payment System. The AHA also commented on bills to provide grants for the adoption of cybersecurity best practices, direct the Department of Health and Human Services to create a strategy for rural hospital cybersecurity staff training, and improve obstetric emergency preparedness in rural healthcare settings.” 
       
  • MedPage Today relates,
    • “Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearing Tuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • “Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearingopens in a new tab or windowTuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • “Committee chairman Sen. Mike Crapo (R-Idaho) took the opposite view. “You have met all of the requirements and standards of this committee in vetting a nominee, and you are completely and well qualified to be deputy secretary at the Department of Health and Human Services,” he told Klomp.” 
  • The Wall Street Journal adds,
    • “Pennsylvania health officials announced Tuesday a fourth measles-associated death, the latest fatality in the commonwealth where recently reported deaths from the vaccine-preventable disease have inflamed politics at the local and national level.
    • “The death follows those of two infants in the state’s Lancaster County in mid-August amid a growing measles outbreak. The state health department’s classification of those deaths spurred a highly politicized debate over vaccinations and sparring between the state’s Democratic governor and the nation’s health secretary.
    • “Over the weekend, a coroner in Pennsylvania’s Jefferson County said a 40-year-old woman there died from complications from measles. The Mifflin County Coroner’s Office on Tuesday said an 18-year-old resident died due to a rare neurological complication from measles. The state health department said it worked with local coroners’ offices to determine both individuals tested positive for measles and the deaths didn’t result from an unrelated cause.
    • “That’s four total measles-associated deaths in our Commonwealth and the first Pennsylvania has seen in 35 years,” Pennsylvania Gov. Josh Shapirosaid in a post on social media Tuesday. “These are tragedies, and four families are grieving.”
  • Per a U.S. Census Bureau news release,
    • “The U.S. Census Bureau today announced that real median household income was $87,460 in 2025, the highest on record dating back to 1967.
    • “The official poverty rate fell 0.5 percentage points to 10.2% in 2025. The following 2025 findings were not statistically different from 2024: the Supplemental Poverty Measure (SPM) rate in 2025 was 13.1% and in 2025, 26.7 million people (7.9%) were uninsured for the entire year, according to the 2026 Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
    • ‘These findings come from three Census Bureau reports, “Income in the United States: 2025,” “Poverty in the United States: 2025” and “Health Insurance Coverage in the United States: 2025.”
  • Beckers Hospital Review tells us,
    • CMS will add four condition tracks to its Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model starting in spring 2027, the agency said in a Sept. 15 news release.  
    • Four things to know: 
      • “The expansion adds heart failure, chronic obstructive pulmonary disease, substance use disorders and tobacco cessation to the model. CMS will also expand support for chronic musculoskeletal pain, extending coverage for certain conditions beyond the model’s initial 12-month care period.
      • “The model already covers hypertension, diabetes, chronic musculoskeletal pain and depression. CMS says 3 out of 4 Medicare beneficiaries qualify for at least one track.
      • “The ACCESS model ties Medicare payments to measurable improvements in patient health rather than paying solely for individual services. Participating organizations can offer virtual care, health coaching, remote monitoring, and connected devices and wearables between regular doctor visits.
      • “There are currently 160 organizations participating in the ACCESS model, and CMS said Medicare will continue to add to the list throughout the model’s 10-year run. The model supports those with traditional Medicare. Medicare Advantage enrollees are not eligible, but CMS said MA plans may offer similar programs.”

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

  • OPM included the following additions in today’s Federal Register.
    • Rules
      • Reduction in Force; Correction
      • Shared Certificates and Pooled Hiring Actions
    • Proposed Rules
      • Promoting Employee Accountability
  • Federal News Network reports,
    • “The fewest number of federal employees submitted their retirement papers in August as compared to the rest of 2026. The Office of Personnel Managements says it received only 7,618 retirement claims last month. This is down from more than 10,000 claims OPM received in July. Additionally, OPM’s backlog of retirement claims is at the lowest of the year at just over 15,400. The average number of days to process a claim for August also dropped considerably: to 70 days for a digital claim, down from 98 days the month before, and to 79 days for all claims, down from 109 days in July. (Federal retirement claims down, as the backlog hit lows for 2026 – OPM)”
  • Kevin Moss, writing in Federal News Network, discusses
    • “Healthcare affordability series part 8: Enrollment flexibility for two-person families can lead to premium savings.”
      • “Most of the time, self-plus-one is cheaper, but there are plans where you’ll save more enrolling as self & family.”
  • Govexec relates,
    • “More ‘Big Balls’-type young feds are what the OPM chief wants 
      • “In an interview on Monday, Scott Kupor also discussed implementing skills-based hiring, which had been a priority of the Biden administration as well.”

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

  • STAT News relates,
    • “The Food and Drug Administration is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday. 
    • “The pilot was first announced in June as part of Operation TrialBlazer, the Department of Health and Human Services initiative that pledged to shorten the FDA’s drug approval timelines and help the U.S. compete with the rapidly accelerating biotechnology industries in countries like China and Australia.
    • “Too often, the U.S. pathway can be measured in years, while other countries’ pathways are measured in months,” the department wrote in the TrialBlazer roadmap.”
  • and
    • “Vera Therapeutics said Tuesday that its recently approved drug Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in patients with a chronic autoimmune kidney disease, according to final, two-year results from a Phase 3 clinical trial. 
    • “In July, the Food and Drug Administration granted accelerated approval to Trutakna for the treatment of IgA nephropathy, or IgAN, a disease caused by the buildup of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.
    • “With the final data from the study in hand, Vera said it will seek full approval of the drug from the FDA during the fourth quarter.”
  • Cardiovascular Business tells us,
    • “XCath Robotics has received the FDA’s breakthrough device designation for its Iris surgical robotic system that performs remote robotic-assisted mechanical thrombectomy in acute ischemic stroke patients.
    • “This represents a significant step forward for the Houston-based medtech company. The FDA’s breakthrough devices drogram helps support the development of medical devices that have the potential to provide more effective treatment for patients with life-threatening or irreversibly debilitating conditions. This provides XCath Robotics with more opportunities to interact with FDA experts and receive support as the company works toward U.S. regulatory approval for the Iris system.
    • “Back in March, the Iris system was used to complete the world’s first telerobotic stroke thrombectomy. Neurosurgeon Vitor Mendes Pereira, MD, chair of advanced neurovascular interventions at the University of Toronto, used the system to perform the historic procedure in Santiago, Panama, while the patient was 120 miles away in Panama City.”

No Surprises Act News

  • The FEHBlog did receive his CMS invitation to join its Independent Dispute Resolution Gateway this morning, and the FEHBlog promptly took CMS up on its offer. The process went smoothly.
  • The Paragon Institute September 15, 2026, Newletter’s kicks off with an article about “Fixing the No Surprises Act’s Broken Arbitration System.”
    • “Congress already required much of this transparency through the NSA’s Advanced Explanation of Benefits provisions, but those requirements have yet to be fully implemented. The administration should finish that work. Once patients have meaningful advance information about networks and prices, there is no justification for a federal arbitration system setting payments for elective care.
    • “For emergency services, a different approach is needed, and Congress has two reasonable options. It could eliminate federal IDR entirely while maintaining the prohibition on balance billing, leaving insurers and providers to settle payment disputes through private arbitration, litigation, or state law.
    • “Alternatively, Congress could retain IDR solely for emergency services but impose meaningful guardrails. Awards should have a reasonable upper limit so arbitration does not continue producing payments wildly disconnected from market prices. Congress should also reform how arbitrators are paid, and if an upper limit is implemented, insurers should face penalties when they fail to pay awards on time.
    • “The administration can make additional improvements now: require arbitrators to explain their decisions, audit firms with unusually high provider win rates or awards, strengthen eligibility reviews, improve arbitrator training, prohibit conflicts of interest and forum shopping, and restore a meaningful filing fee.
    • “The No Surprises Act solved a real problem by protecting patients from bills they could neither anticipate nor avoid. Those protections should remain. But protecting patients from surprise bills does not require a federal arbitration system that rewards providers for staying out of network and raises health care costs for everyone.”

From the fraud, waste, and abuse front,

  • Healthcare Dive reports,
    • “The federal government is once again targeting fraud in durable medical equipment suppliers, publishing a report Monday through the HHS’ Office of the Inspector General that urges regulators to crack down on suspect billing in Medicare Advantage.
    • “The OIG found that, in addition to other issues, MA organizations don’t screen for fraudulent medical equipment suppliers as often when they’re out of network, compared to in-network suppliers.
    • “MA organizations should tighten the screening process for suppliers and the CMS should use its fraud prevention tool more regularly, the OIG said.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “In recognition of Suicide Prevention Month, Susan Szulewski, M.D., president and chief operating officer, McLean Hospital and vice president, Mass General Brigham Behavioral and Mental Health, wrote on the importance of healthcare organizations working to reduce the stigma surrounding suicide and create a supportive environment with timely access to care and a clear path forward. READ MORE“
  • Per a CDC news release,
    • “Today, the Centers for Disease Control and Prevention and the Ad Council are launching a new round of public service announcements (PSAs) encouraging people to understand their risk of prediabetes and take action to prevent or delay type 2 diabetes.
    • “Now in its 10th year, the national “Do I Have Prediabetes?” campaign encourages viewers to take a 1-minute prediabetes risk test on DoIHavePrediabetes.org. This year’s “Undo It” PSAs spotlight that while there are many scenarios in life we can’t undo, prediabetes is something that can be reversed. 
    • “Prediabetes is a serious health condition that increases the risk of type 2 diabetes, heart attack and stroke. Because prediabetes often has no symptoms, many people do not know they have it. Research shows that early diagnosis can inspire individuals to adopt healthier habits, including eating better, being active and managing weight, that can reverse prediabetes and delay or prevent type 2 diabetes.
    • ‘If someone receives a high score on the risk test, that person is encouraged to speak to a doctor to confirm a diagnosis of prediabetes with a blood test, then enroll in the National Diabetes Prevention Program.” 
  • Healio tells us,
    • “Development of alcohol use disorder, depression or stress after a traumatic event was a strong predictor of major adverse cardiac and cerebrovascular events for both men and women, researchers reported.
    • “Evaluation of psychiatric predictors of major adverse events may be an important step in the prediction of CV risk after a traumatic event, according to data published in the Journal of the American Heart Association.
    • “Experiencing traumatic events can have long-lasting consequences for mental health that can take many forms, but research to date had yet to comprehensively consider these. Indeed, nearly all work on trauma and CVD had focused on PTSD and other stress-related disorders — the quintessential trauma-related mental health disorders — but depression, anxiety and substance use disorders are also common following trauma and are relevant to cardiovascular disease risk,” Jennifer A. Sumner, PhD, associate professor of psychology at the University of California, Los Angeles, told Healio. “We wanted to comprehensively investigate different posttraumatic mental health conditions as possible predictors of CVD onset. Also, given sex differences in both posttraumatic psychopathology and CVD, we examined whether links between various psychiatric disorders following trauma and CVD might differ for men vs. women.”
  • Health Day informs us
    • “New research suggests that the blood pressure and heart rate guidelines doctors use to guide emergency treatment in children are misleading in cases of traumatic injury. 
    • “These thresholds for “hemodynamic instability” — the inability of the circulatory system to get blood to organs — may be different for children with traumatic injuries versus healthy children, researchers wrote Sept. 9 in the Journal of the American College of Surgeons.
    • “Recognizing hemodynamic instability is fundamental in trauma care because these vital signs tell us when a child may be at increased risk of death or complications and when we may need to intervene,” explained study senior author Dr. Zain Hashmi. He’s an assistant professor of trauma and acute care surgery at the University of Alabama at Birmingham.
    • “Blood pressure and heart rate guidelines are often used by doctors to decide when to start resuscitation treatments, including blood transfusions, Hashmi said in a news release. However, the values used in children were not developed specifically for trauma patients and may not accurately reflect when the risk of death begins to rise in injured children, he added.” 
  • Medscape points out,
    • “A new international consensus statement providing evidence-based guidance on smoking cessation for people with type 2 diabetes (T2D) has been issued by a multidisciplinary international panel called the DiaSmokeFree Working Group. 
    • “The central message “is that smoking cessation needs to be treated as an integral part of diabetes management rather than as generic lifestyle advice,” statement co-author Riccardo Polosa, MD, PhD, professor of internal medicine at the University of Catania in Catania, Italy, told Medscape Medical News.
    • “There is evidence that this is under-prioritized in diabetes care,” he added. “Clinicians understandably focus on glucose, blood pressure, lipids, and medications, while smoking may receive only brief and mostly ineffective advice.”
  • Today’s issue of NIH’s Research Matters covers the following topics:
    • “Depression may stall development of new neurons 
      • “Researchers found that a part of the brain important for memory struggles to make new neurons in people with depression.
      • “The study sheds light on how the brain is altered in depression and suggests new treatment targets.”
    • GLP-1 drug slows aging in mice 
      • A GLP-1 drug extended lifespan and prevented age-related decline in older female mice.
      • Understanding how calorie restriction and GLP-1 drugs slow aging could lead to new ways to treat age-related diseases.
    • Antibodies may prevent tick-related syndrome 
      • “Researchers identified rare antibodies that may help combat alpha-gal syndrome, a condition that causes allergic reactions to red meat and dairy products.
      • “With further development, the finding could lead to treatments for this tick-related allergic condition.”

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

  • Beckers Payer Issues reports,
    • “Aetna’s two-year financial turnaround has taken hold following a leadership overhaul, thousands of ongoing cost management initiatives and a margin recovery plan expected to complete by 2027.
    • “Once you get the fundamentals in place, you start getting credibility, not only with investors, but internally with our employees, and then, in particular, with our members,” Aetna President Steve Nelson said Sept. 9 at the Wells Fargo Healthcare Conference. “We can be a little more disruptive and innovative. Aetna has a legacy of being innovative in terms of product and clinical programs, and we are getting back to that.”
    • “The insurer has spent the past two years in recovery mode after a period of financial turmoil driven by Medicare Advantage cost pressures, previously unfavorable star ratings and major losses in the ACA business, which it exited for 2026. Mr. Nelson, who also serves as executive vice president at CVS Health, was tapped to lead the insurer in late 2024.”
  • and 
    • “Health Care Service Corp. has completed the rebranding of its Medicare supplement and supplemental health and life products under the HealthSpring name.
    • “The move finishes a transition that began last year, when HCSC shifted the Medicare Advantage and Part D business it acquired from Cigna for $3.3 billion to the HealthSpring brand. 
    • “HealthSpring has more than 3 million members. HCSC said it is the second-largest Medicare supplement carrier by policyholders, with plans available in 48 states and Washington, D.C. Its supplemental health and life products, which include hospital indemnity and dental, vision and hearing benefits, are offered in 49 markets and D.C.”
  • and
    • “The Blue Cross Blue Shield Association has tapped Daniel Serrano to serve as CFO.
    • “The president and CEO of the BCBS Association, Kim Keck, announced the update Sept. 14 on LinkedIn. 
    • “With critical capabilities for this moment, including a practitioner’s orientation to data-driven financial management and a strong track record of aligning financial performance with operational outcomes, Dan is a great fit for our organization,” she said.”
  • Fierce Healthcare adds,
    • “Member trust in insurers is on the decline among Gen Z and Millennials, down 10.5% between 2023 and 2026, new research from Accenture found.
    • “This trust gap, according to analysts, could cost $3 billion in future member lifetime value for the largest commercial payers over the next decade. 
    • “When members don’t trust their health plan, they don’t just disengage; they route around it,” said Bracken Flynn, Accenture’s Health industry principal director, in a statement. “Our data shows that younger consumers aren’t asking for less from their insurer. They want more. They’re looking for a partner that helps them navigate care, understand costs, and make confident decisions. The insurers that earn that trust now will define what health coverage means for the next generation.”
    • “During a Sept. 14 AHIP webinar, Flynn said the report—which polled 1,200 consumers—found members trust insurers when they believe the health plan will help them make good healthcare decisions and navigate them to the best care.
    • “That’s across clinical and administrative touchpoints,” Flynn said. “And so it’s a partnership. In practice, it’s a partnership.”
    • “The lack of trust in insurers is causing younger members to turn to artificial intelligence tools, with 62% of respondents saying they have used AI to help choose a health plan.”
  • The American Hospital Association News relates,
    • “A new report from Kaufman Hall prepared for the AHA highlights new insights and data on hospital mergers and acquisitions. An AHA blog accompanying the report is also available.
    • “The report discusses how hospital merger reviews should look beyond the potential impact on commercial insurance prices and consider what proposed transactions mean for all patients, particularly the nearly 60% of hospital patient days attributable to Medicare, Medicaid and Medicare Advantage beneficiaries whose payment rates are largely set by government programs. Drawing on analyses of challenged and canceled transactions, the report also finds that hospitals seeking partners often serve more vulnerable communities and face greater financial pressures, and that when proposed deals do not move forward, struggling hospitals can experience significant financial deterioration that threatens services, workforce stability and access to care.
    • “These findings suggest that a more comprehensive analysis of hospital M&A transactions, one that considers impacts on all patients served, broadens the focus to impacts beyond pricing, and considers the consequences if an M&A transaction is not permitted to proceed, would ensure not only competitive but also healthy hospital markets that can continue to provide the fullest possible range of services,” the report says.”
  • AHIP relates,
    • “New data highlighted by Washington Post Intelligence show hospital system consolidation continues to accelerate, with 40 new mergers and acquisitions announced already in the first half of 2026 — nearly as many as throughout all of 2025. 
    • “Clear evidence demonstrates that anticompetitive hospital consolidation leads to higher healthcare costs for patients, families and employers. Hospital spending already makes up the largest share (40%) of insurance premiums, accounting for over $1.6 trillion in spending nationwide.”
  • Beckers Hospital Review adds,
    • “Salt Lake City-based Intermountain Health has acquired the nine-story, 235,000 square-foot Fairbourne Building in West Valley City, Utah, and plans to convert it into a medical campus.”
  • and
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said.”
  • Cardiovascular Business points out,
    • “U.S. News & Report has published its annual ranking of the top children’s hospitals in the United States, once again producing a separate list for the best hospitals for cardiology and heart surgery. This represents the 20th year that U.S. News.& World Report has compiled these rankings.
    • “For two decades, U.S. News has helped guide families to top-tier pediatric care,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement. “Finding the right medical team for a rare diagnosis or complex surgery can be overwhelming, and U.S. News’ annual evaluation of the Best Children’s Hospitals provides a clear starting point for parents and referring pediatricians alike.”
    • “Nearly 200 U.S. facilities were eligible for these rankings. Each one is either a freestanding children’s hospital or a large multidisciplinary pediatric department working within a major medical center.
    • “This latest ranking of the Best Children’s Hospitals for Cardiology and Heart Surgery includes some familiar names at the top. For instance, Texas Children’s Hospital in Houston is No. 1, just like it was in 2019, 2020, 2021, 2022, 2023, 2024 and 2025. 
    • “Meanwhile, Children’s Hospital Colorado and Duke Children’s Hospital and Health Center are No. 2 and No. 3, respectively. That is where each one landed in the previous year’s ranking as well. 
    • “Going a bit deeper, Children’s Hospital of Philadelphia came in at No. 4, and Children’s Health Dallas came in at No. 5.” 
  • MedCity News lets us know,
    • “Virtual solutions for chronic kidney disease (CKD) management don’t slow disease progression, nor do they reduce total healthcare spending, according to a new analysis by the Peterson Health Technology Institute (PHTI).
    • “PHTI is an independent evaluator of digital health solutions. For the analysis, PHTI reviewed more than 5,400 articles and other evidence. The solutions evaluated in the report include DaVita IKC, Evergreen Nephrology, Healthmap Solutions, Interwell Health, Kidneylink, Monogram Health, Somatus and Strive Health. These companies take on financial responsibility for the total cost of care for patients with stage 3–5 CKD, and typically work with Medicare Advantage plans and Medicare’s Kidney Care Choices model.
    • “The assessment focuses on managing chronic kidney disease before patients progress to end-stage kidney disease, including the need for dialysis or a kidney transplant.”
  • Managed Healthcare Executive tells us,
    • “GLP-1s now dominate market momentum, with obesity products surging from near-zero in 2022 to $55B annually and diabetes GLP-1s sustaining double-digit year-over-year growth. 
    • “Independent pharmacies are reassessing dispensing economics, with refusal rates declining to 35% for weight-loss GLP-1s and 8% for diabetes GLP-1s. 
    • “Distribution remains retail-heavy (~80%), but mail fulfillment is increasing, reaching 12.9% of GLP-1 prescriptions as direct-to-consumer channels expand. 
    • “Diabetes category mix is shifting away from insulin, whose sales share has dropped to 9.8% and prescription share to 16%, reflecting GLP-1 substitution dynamics. 
    • “Medicare Part D Bridge uptake appears immediate, with 9,000 paid claims in three days, alongside a large pipeline exploring neuropsychiatric, SUD, cancer-risk, women’s health, and systemic inflammation indications.”
  • The Wall Street Journal informs us,
    • “Legend Names Novartis Executive as CEO
      • “Ingrid Zhang takes the helm of the cancer therapy company, filling a post vacant since its previous CEO abruptly resigned in July.”
  • Per Beckers Health IT,
    • “Oracle has expanded its fiscal 2026 restructuring plan by approximately $700 million, bringing expected costs to roughly $2.8 billion as the company pursues strategic initiatives and operational efficiencies that include adopting and integrating AI across certain functions.
    • “The Sept. 11 Securities and Exchange Commission filing does not specify what actions the additional $700 million will cover or how many employees could be affected. Oracle said restructuring expenses under the broader plan include employee severance, contract termination and other exit costs.
    • “As of Aug. 31, prior to the additional $700 million, Oracle estimated total restructuring costs of up to $2.1 billion.
    • ‘The disclosure comes as Oracle employees across social media reported a recent round of layoffs, including at Oracle Health. Business Insider first reported the layoffs Sept. 14, citing three people affected and an email notification.”
  • and
    • “Mayo Clinic and Thermo Fisher Scientific have launched Precure, a joint venture designed to detect biological signs of disease before patients develop symptoms, according to a news release shared with Becker’s.
    • “Rochester, Minn.-based Mayo Clinic, will serve as majority owner of the entity and Thermo Fisher joins as a minority partner. Precure will build one of the world’s largest human multi-omics datasets — integrating proteomic and genomic data with longitudinal clinical information drawn from 1 million biospecimens collected over several years, according to the release.
    • “At Mayo Clinic, we are committed to transforming patient care through innovation,” said Gianrico Farrugia, MD, president and CEO of Mayo Clinic. “By harnessing the full potential of multi-omics data, Precure, LLC aims to help us better understand disease before symptoms appear.”
    • “Thermo Fisher will contribute its Olink Explore HT proteomics platform and Orbitrap mass spectrometry technology to the effort. Marc Casper, Thermo Fisher Scientific’s chairman and CEO, said the venture has “the potential to create a step change in how we generate and apply multi-omics data to improve human health.”
    • “Target disease areas include cancer, cardiometabolic conditions, neurological disorders and immune-mediated disease — conditions where biological changes often precede clinical diagnosis by years. Advanced AI and large-scale data analytics will be used to identify patterns across the datasets and translate them into actionable insights.”
  • Per Beckers Clinical Leadership,
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said. 
    • “These efforts aim to create a public, multimodal dataset to “help reach a future where cancer patients can get rapid personalized cancer vaccines when they are diagnosed,” the OpenAI Foundation said in a Sept. 15 news release. 
    • “UNC Lineberger’s $40 million grant is part of a $125 million funding program, called Public Data for Health, established by the foundation.”
  • and
    • “Ambient artificial intelligence handed many physicians their evenings back. For nurses, the same promise is proving harder to keep, and the reason is buried in the flow sheet.
    • “Physician ambient scribes listen to a visit and draft a narrative note when it ends. Nursing documentation does not work like that. It lives in structured flow sheets, entered field by field across a shift, every time a nurse assesses, medicates or turns a patient.
    • “Nursing documentation occurs throughout the entire shift. It’s every time we interact with a patient,” said Stephanie Clements, BSN, RN, senior vice president and chief nurse executive at Chesterfield, Mo.-based Mercy. “It’s very different than summarizing care at the end of a period.” 
    • “That difference is why early attempts to copy the physician model — record the encounter, generate the note — have not mapped cleanly onto the bedside, and why some nurses have found the tools slower, not faster, at first.
    • “Yet the systems furthest along say the payoff is real when the technology is built for nurses from the get-go.” 

Notable Deaths

  • The New York Times reports
    • “Harold P. Freeman, an influential oncology surgeon whose knowledge of the devastating effects of breast cancer on poor Black women inspired him to create a landmark program at Harlem Hospital Center, helping patients navigate the health care bureaucracy, died on Aug. 11 in Atlanta. He was 93.
    • “His death, at a hospital, was confirmed by his son Neale.
    • “Dr. Freeman’s patient navigation program became a model for hospitals around the world, helping to eliminate barriers to early cancer detection. The program’s success influenced the passage of the federal Patient Navigator Outreach and Chronic Disease Prevention Act of 2005, which provided $25 million for similar programs across the United States. In 2024, Medicare began providing providers with reimbursement for some navigation services for cancer, heart failure, H.I.V./AIDS and other high-risk conditions.
    • “There are no navigation events or meetings that don’t acknowledge Dr. Freeman’s role in patient navigation,” Dr. Shanthi Sivendran, the interim chief patient officer of the American Cancer Society, said in an interview. “There wasn’t a patient navigation concept before him.”
  • and
    • “The milk truck would pull up to the house, and out would come the groceries — not just milk, but also eggs, cheese, juice, cereal and baby formula. It might have stopped at a rich family’s house, or a poor one. No one could tell the difference, which was precisely the point.
    • “Vermont’s supplemental food program for low-income women, infants and children, the first in the nation to be implemented statewide, began in 1974. It was the brainchild in part of Dr. Anthony Robbins, then one of the country’s youngest state health commissioners, at 33; he had secured a federal grant to made the program possible.
    • “Not only did the program provide much-needed supplies, but it also shielded families from the stigma of receiving public assistance.
    • “The milk truck was stopping at practically every house — high income, low income, whatever,” Donna Bister, a former director of the program, known widely as WIC, said in an interview. The program is now available in all 50 states.” * * *
    • “Dr. Robbins died on July 5 at his home in Rockport, Mass. He was 85. His death, which was not widely reported at the time, was caused by complications of long Covid, heart disease and Parkinson’s disease, his wife, Phyllis Freeman, said.
    • “He was considered to be on the cutting edge of health care,” Madeleine Kunin, a former governor of Vermont, said in an interview. “He was a bright light.”
  • RIP Doctors.

Weekend update

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Hill explains,
    • “House and Senate lawmakers will return to Washington this week with a packed agenda before much of their focus shifts to the fast-approachingmidterm elections.
    • “The Senate is expected to continue talks over the budget resolution and hold a procedural vote on the cryptocurrency regulation bill, among other priorities. The House, meanwhile, will reportedly consider a Senate-passed Russia sanctions bill prior to departing again until mid-November, after House Republican leaders recently cut two weeks from the chamber’s September schedule ahead of the midterms.”
  • MedPage Today reports,
    • “Healthy Moms, Healthy Babies America, a bipartisan campaign founded by philanthropists Olivia and Tom Walton, announced a $100 million pledge to make giving birth in the U.S. safer.
    • “The 5-year commitment aims to cut the maternal mortality rate in the U.S. in half by 2031.
    • “For millions of moms in America, maternal health is bad and getting worse,” Olivia Walton told the Associated Press in an interview. “There’s just so much bipartisan consensus around wanting to fix this. I really think the political will is there and part of our job is to help surface that with an information campaign.” * * *
    • “According to the most recent data available, the U.S. has one of the highest maternal mortality rates among wealthy nations. The CDC said 688 people died in 2024 during pregnancy or shortly after giving birth. The maternal mortality rate rose to 19 deaths per 100,000 live births in 2024, up from 18.6 the year before.
    • “Improving data collection and accelerating hospitals’ reporting of deaths is an important pillar of the new Healthy Moms, Healthy Babies America initiative, Walton said. The most recent state-level data on maternal mortality is still from 2022, with annual totals based on provisional data available through 2024.”

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

  • Per Department of War news release,
    • “The Department of War has extended and expanded the Pilot Health Insurance Enhancement for DOW Civilian Employees in Japan, reaffirming its commitment to securing high-quality healthcare navigation and mitigating upfront medical costs for its overseas civilian workforce and their families.
    • “The contract extension, awarded to International SOS Government Services, Inc., begins Sept. 30, 2026, and runs through Sept. 29, 2027. In direct response to feedback from the DOW civilians, eligibility is now expanded to include authorized dependents of DOW civilian employees, provided they are enrolled in a participating Federal Employee Health Benefit plan.” * * *
    • “The pilot program, which originally launched on Jan. 1, 2025, was designed to provide no-cost supplemental health support services to DOW civilian employees. The program addresses longstanding challenges in navigating Japan’s healthcare system and managing upfront medical costs. In response to DOW civilian employee feedback, the program previously added interpreter services to address language barriers and improve access to care.
    • “Alongside the expansion of eligibility to dependents and as part of the contract extension, the program is updating call center hours. Beginning Sept. 30, 2026, the bilingual call center will operate Monday through Friday, from 7 a.m. to 7 p.m. Japan Standard Time.
    • “To participate in the pilot, DOW civilian employees and their dependents must be enrolled in one of the following participating FEHB plans:
      • “Federal Blue Cross Blue Shield
      • “Foreign Service Benefit Plan
      • “Hawaii Medical Service Association
      • “Government Employees Health Association
      • “Mail Handlers Benefit Plan
    • “Nonappropriated Fund employees and their dependents in Japan are also eligible if enrolled in Aetna International and should coordinate support through their insurance carrier first.”

From the Food and Drug Administration front,

  • MedCity News reports,
    • “Nutromics landed FDA breakthrough device designation this week for its wearable patch that monitors vancomycin levels in real time. 
    • “Vancomycin is a widely used antibiotic for treating life-threatening infections like sepsis, but it’s notoriously difficult to dose correctly, with doctors typically relying on periodic blood draws to track it.
    • “Nutromics was founded in 2017 with the goal of replacing these blood draws with continuous data for the roughly 2.9 million patients in the U.S. who receive vancomycin each year. The new designation gives the company faster, closer engagement with the FDA as it works toward an eventual commercial launch.”

No Surprises Act News

  • On September 15, 2026, the Centers for Medicare and Medicaid Services will open its Independent Dispute Resolution Gateway to registration by non-initiating parties, typically health insurers and plans.
    • “All potential users of the IDR Gateway can begin creating accounts on September 15, 2026.
    • “Your organization should select at least one IDR Gateway administrator (CMS recommends two, and no more than 10) to set up your organization in the IDR Gateway.
    • “The Federal IDR Team will email selected administrators instructions to create their accounts and set up their organizations.
    • “If your organization selects you as an administrator and the Federal IDR Team did not email you instructions, email IDRGatewayHelp@cms.hhs.gov.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A 40-year-old Pennsylvania woman died Saturday from complications associated with measles, the local coroner said.
    • “It was the first measles-related death in Jefferson County, according to county coroner Greg Furlong. The woman was unvaccinated, Furlong said.” * * *
    • “Measles cases in the U.S. are at their highest level in three decades, with 3,924 confirmed cases so far this year, according to the Centers for Disease Control and Prevention. There were 2,289 confirmed measles cases in the U.S. last year, including the first measles-related death in a decade.
    • “The rapid spread illustrates a new normal in the U.S., where falling vaccination rates have made more communities vulnerable to the highly infectious disease that the country declared eliminated more than 25 years ago.”
  • The Washington Post relates,
    • “The number of cancer deaths estimated to be attributable to alcohol in the United States doubled from 1990 to 2023, particularly among men and people aged 55 years and older, according to a University of Miami study published this month, adding to the body of recent research underscoring the health risks of alcohol consumption.
    • “Around 23,126 people died of alcohol-attributable cancer in 2023, up from 11,361 in 1990, according to the study, which estimated the deaths using a global database of disease mortality and population-level estimates of alcohol exposure.
    • “The impact of alcohol, a known carcinogen, increased over the past decades as cancer mortality decreased overall, according to the study. 
    • “Even though overall the cancer mortality was going down for some of these cancers … alcohol-associated mortality was going up,” said Chinmay Jani, a hematology-oncology fellow at the University of Miami’s Sylvester Comprehensive Cancer Center and one of the authors of the study. “Which means that alcohol as a risk factor was impacting more cancer deaths in 2023 than it was in 1990.” * * *
    • “Gilberto Lopes, chief of the division of medical oncology at Sylvester and another author of the study, added that the data did not establish a safe threshold for alcohol consumption. 
    • “It is difficult to ascertain exactly what the safe level of alcohol is,” Lopes said. But “it is quite clear that we do know the mechanisms through which alcohol causes cancer. So that there’s no dispute about.”
  • The New York Times considers whether “Motion Sickness is Preventable?”
    • “Experts say there are ways to stave off that dreaded queasy feeling.”
  • Health Day tells us,
    • “A widely used weight-loss and diabetes drug may offer a surprising bonus: healthier lungs.
    • “Researchers compared tens of thousands of patients prescribed either a GLP-1 medication or another type of diabetes treatment to see if they helped with asthma or COPD.
    • “The results: Only one — semaglutide, the active ingredient in drugs like Ozempic and Wegovy — made a difference.
    • “It was associated with nearly 40 percent fewer asthma attacks and 20 percent fewer COPD flare-ups.
    • “No significant association was found with the other GLP-1 meds, regardless of dose or underlying lung disease.
    • “The lead researcher calls the findings encouraging but says, for now: “People with asthma or COPD should not start GLP-1 receptor agonists specifically for their lung condition outside current prescribing guidance.”
  • STAT News informs us,
    • “AstraZeneca said Friday that a breast cancer pill failed in a pivotal trial testing it as a first-line therapy in advanced tumors, a result that could limit the use of the medicine.
    • “The drug, camizestrant, in combination with another medicine did not outperform standard treatment on a measure of how long patients went before their cancer progressed. The SERENA-4 trial enrolled patients with ER-positive, HER2-negative advanced cancer who hadn’t had another systemic therapy for advanced disease.”
    • “Camizestrant earlier this month won accelerated approval in the U.S. as Etcamah as a treatment for patients who develop a mutation in their tumors that’s a sign of emerging drug resistance. The SERENA-4 trial, had it been successful, could have opened up a much larger market for the drug. 
    • “AstraZeneca is also testing camizestrant in early breast cancer.
    • “Early breast cancer represents an important opportunity, and we remain confident in the long-term potential of Etcamah in the early setting as we advance our broader program,” Susan Galbraith, AstraZeneca’s head of oncology R&D, said in a statement, adding that the company was “disappointed by the SERENA-4 outcome.”
  • The New York Times points out,
    • “Until last Friday, cardiologists thought they were on the verge of a new frontier in treating heart disease.
    • “Three companies were conducting large clinical trials on experimental drugs that slash levels of a blood protein, Lp(a), thought to cause heart attacks and stroke. Doctors were eagerly awaiting the results, hoping the drug could be as important as a statin.
    • “When Novartis, the first company to complete its trial, announced its results, late Friday afternoon, after the markets closed, cardiologists were shocked. The drug could lower Lp(a) levels by 80 percent, but it did not prevent heart attacks and strokes. It had failed.
    • “There’s something we don’t understand here,” said Dr. John Alexander, a cardiologist at Duke.
    • “Cardiologists regularly see patients who have had heart attacks even though their cholesterol and blood pressure levels are low. They do not have diabetes or obesity, and they do not smoke, either. All too often, though, they have high levels of Lp(a).”
    • “About 20 percent of Americans have elevated levels; people with the highest levels of the protein can have double or triple the risk of a heart attack.
    • “So there was no question that Lp(a) was important. A drug to lower the level of the protein, cardiologists hoped, could provide a way for these patients to protect themselves.
    • “But the failure of the Novartis study raised an uncomfortable possibility: Maybe Lp(a) is not a cause of heart disease, but instead is a marker of heart disease risk, like white hair is a mark of aging.
    • “If Lp(a) is a marker, though, what is it marking? Is there another cause of heart disease that no one has thought of?
    • “That is “the nagging question we are all pondering,” said Dr. David Maron, president of the American Society for Preventive Cardiology.”

From the U.S. healthcare business front,

  • Benefits Pro reports,
    • Executives from Aetna and its parent, CVS Health, are hoping that focusing on Aetna’s relationships with doctors will be good medicine for soaring health coverage costs.
    • Steve Nelson — an executive vice president at CVS and president of Aetna — talked about Aetna’s efforts to hold down health coverage cost increases today [September 9, 2026], in Boston, during a session at a health care conference for investors organized by Wells Fargo.
    • “Absolute health care costs are still much higher than any of us would like to see them,” Nelson said.
    • “Aetna is organizing about 2,000 different initiatives to get cost trends under control, he said.
    • “If initiatives to support relationships with the providers succeed, that should make many of the initiatives work more smoothly, Nelson said.
    • “CVS streamed audio of the call live on the web and posted a recording online.”
  • Reuters relates,
    • “GE HealthCare Technologies (GEHC.O) is ​in talks over a possible $1 ‌billion deal to buy radiopharmaceutical developer Sofie Biosciences, the Financial Times reported on ​Sunday [September 13, 2206], citing people familiar with ​the matter.
    • “A deal ⁠for Sofie, which specializes in ​radioactive chemicals used in cancer scans, ​could be announced as soon as next week, the report said.
    • “Reuters could not immediately ​verify the report. GE HealthCare ​declined to comment while Sofie Biosciences could ‌not ⁠be immediately reached for comment outside regular business hours.”

Cybersecurity Saturday

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

From the frontier AI / Project Glasswing front

  • Daniel Borish writes in LinkedIn,
    • “Anthropic released its fourth threat intelligence report on September 10, 2026, covering activity its Threat Intelligence team disrupted between December 2025 and August 2026. The report documents cases across seven categories of harm: cyber operations, surveillance, influence operations, conventional weapons development, biological misuse, scams and fraud, and illicit distillation. The company assigns each disrupted actor an internal designator, a Generative Threat Group (GTG) number, and publishes case studies detailing how each group used Claude models, along with indicators of compromise for other defenders to act on.
    • “The report’s central claim is not that AI created new categories of attack. Credential theft, phishing, SQL injection, and unpatched edge devices remain the entry points they have always been. What changed is who can run these attacks at what speed. Anthropic’s investigators found a suspected Russian state espionage unit, a network of financially motivated ShinyHunters affiliates, Chinese university students moonlighting in exploit research, and a lone French hacktivist all using functionally similar AI-orchestrated methodologies to run multi-victim campaigns that would previously have required coordinated teams.”
  • The Wall Street Journal reports,
    • “Artificial intelligence agents being tested by OpenAI launched a cyberattack against a popular software service two months before they hacked the AI software company Hugging Face, a new signal of the potential for advanced AI tools to slip out of human control.
    • “The attack overwhelmed maintainers of an online service for coders, called RubyGems, and forced them to shut down new account registrations as they dealt with the chaos it had caused, operators of the service said.
    • “A coalition of AI researchers said it had unearthed evidence that OpenAI agents were behind the May attack and shared its findings with The Wall Street Journal and OpenAI. The AI developer on Friday confirmed that its agents had been involved in an incident involving RubyGems.
    • “Based on our review, our agents used the RubyGems platform to access the internet to carry out benign tasks and retrieve public information. We’ll continue to investigate as part of our broader review of agent activity during training and evaluation,” an OpenAI spokeswoman said in a statement.”
  • and
    • “An Anthropic researcher is quitting the artificial-intelligence industry over fears that the lab and its competitors are racing to build systems they won’t be able to control, a sign of mounting safety concerns within top AI companies.
    • “Jacob Coxon, a researcher who specializes in training new AI models by having them consume vast amounts of data, said Tuesday that he is leaving the company because he doesn’t want to participate in an industrywide rush to build AI systems that can improve themselves, worried such systems could spiral out of control and destroy humanity.
    • “The 27-year old Brit, who previously studied mathematics, said many of his industry colleagues now use phrases like “crunchtime” and “endgame” to describe the trajectory toward self-improving models.” * * *
    • “Anthropic didn’t immediately comment on the departure. Chief Executive Dario Amodei and other company leaders have repeatedly warned about the risks of rogue AI models, and urged the industry to slow development. 
    • “After Coxon announced his departure, a top scientist at the company, Evan Hubinger, wrote on X that he thought Coxon was correct about the risks of AI development.
    • “We really do earnestly believe AI could kill all humans! I personally think it is >10% within the next decade,” Hubinger wrote. “I believe Anthropic is trying its best, but we do not yet have a plan to solve alignment for superintelligence and are not clearly on track to.” Others also amplified the view.”
  • Per Axios: “Nvidia CEO Jensen Huang: AI fears designed to generate cybersecurity business.”
  • BigGo Finance lets us know,
    • “A bipartisan group of US senators is negotiating legislation that would create a legal duty of care for frontier AI developers, requiring them to prevent catastrophic risks and giving the federal government authority to block unsafe model releases. The proposal, led by John Thune, Ted Cruz and Amy Klobuchar, would apply to advanced models from companies such as OpenAI, Anthropic and Google, with national laboratory experts potentially conducting hands-on testing for nuclear, biological and cyber threats. Companies could appeal government blocking decisions in federal court. The measure would also preempt state AI safety laws. With the House in session only one week before the November 3 midterms, passage remains uncertain despite growing pressure on Congress to address frontier AI risks.”
  • Axios adds,
    • “A letter is circulating among House members urging Speaker Mike Johnson (R-La.) to bring back the House “immediately” and keep it in session until Congress passes AI safeguards, Axios has learned.”
  • The Wall Street Journal notes,
    • “President Trump, who has taken a light touch overseeing the sector, previously said he is in favor of kill switches and other steps to keep AI safe but has warned burdensome regulation could cost the U.S. in the tech race.”
  • and
    • “The leaders of three of the biggest AI companies agreed [September 12] that they needed to slow development of the technology before their advances create a menace that can’t be controlled.
    • “It was a rare display of unity by Elon Musk, Sam Altman and Dario Amodei, who have been spending tens of billions of dollars to develop evermore powerful artificial intelligence models. Altman even suggested that his company, OpenAI, may need to delay its much-anticipated IPO to focus on safety.”

From the cybersecurity policy and law enforcement front,

  • Per GovCIO Media,
    • “Federal agencies are looking to deepen their partnership with the private sector to protect critical infrastructure, with joint efforts to identify vulnerabilities, deploy technology and scale solutions.
    • “National Cyber Director Sean Cairncross said Thursday [September 10] at the Billington Cybersecurity Summit in Washington that government and industry need to work “hand in glove” rather than rely on compliance checklists as technology increasingly shapes both critical infrastructure and the threats against it.
    • “We’re in a moment technologically where security and innovation have melded, and in order to move forward, protect critical infrastructure, make sure the systems that our citizens rely on for daily life are protected and secure, we need a relationship that is hand in glove, and that means we cannot be dictating a compliance checklist to industry,” said Cairncross.”
  • Federal News Network reports,
    • “The FBI released its first agency-wide, unclassified cyber strategy on Wednesday, with the goal of unifying efforts across the bureau’s 56 field offices to counter both nation-state threats and cyber criminals.
    • “The 17-page strategy details a four-pillar approach to countering cyber threats across the bureau. Brett Leatherman, assistant director of the FBI’s Cyber Division, said previous cyber strategies for the bureau have either been classified or focused on specific threats, like countering China.
    • “This is a comprehensive strategy that directs our teams, our field offices, our global presence, and how we are to align all our efforts to counter this work,” Leatherman told reporters after speaking at the Billington Cybersecurity Summit in Washington on Wednesday morning [September 9].”
  • and
    • “The CIA is pushing to bring more scientific and technical expertise into its workforce, with a top official touting a big year for hiring despite widespread cuts across the intelligence community over the past year.
    • “Michael Ellis, the deputy director of the CIA, said the spy agency is seeking to recruit more employees with backgrounds in science and technology. Ellis described a STEM background as not a prerequisite for intelligence in work in 2026, but “it sure helps make things easier.”
    • “When I think about, you know, where we want the CIA workforce to be five years from now, it’s an elite workforce,” Ellis said at the Billington Cybersecurity Summit in Washington on Tuesday. “It’s a nimble workforce. It’s one that has more technical background than it has today, and it’s one that is motivated by mission.”
  • Cybersecurity Dive adds,
    • “As the federal government scrambles to protect its own networks and support critical infrastructure operators, CISA is preparing to bring in roughly 250 new employees to rebuild core teams.
    • “We’re looking forward to welcoming hundreds of new CISA employees in the very near future,” acting CISA Director Nick Andersen told reporters after a talk at the Billington Cybersecurity Summit here on Wednesday.
    • “The employees have received tentative job offers and are “waiting to get that official start date,” Andersen said during his speech.”
  • Cyberscoop points out,
    • “The private sector still isn’t sharing enough cyber information with the FBI in part because organizations are operating on false assumptions about what the bureau will do with what it collects, the FBI’s top cyber official said Wednesday.
    • “Brett Leatherman, assistant director of the FBI’s cyber division, said in remarks at the Billington CyberSecurity Summit and in a discussion with reporters that organizations stand to benefit from bringing in the bureau when it’s compromised by hackers from the People’s Republic of China (PRC) and others. But one of the “key misconceptions” is that “the FBI is somehow sharing information with regulators for regulatory purposes, and that’s not the case.”
    • “From my standpoint over the last few years, I think we’ve seen a hesitancy on some companies to engage [with the] FBI,” Leatherman said.”
  • and
    • “The U.S. government is accusing Chinese AI companies of engaging in a deliberate and “systematic” effort to illegally distill U.S. frontier AI models and their capabilities. 
    • “According to a joint cybersecurity advisory from the National Security Agency, the Cybersecurity and Infrastructure Security Agency and the FBI, the sheer scale of these efforts since 2024 indicate that distillation is a critical part of China’s AI industrial policy.
    • “China-based artificial intelligence companies are conducting systematic extraction of proprietary functionalities and capabilities of U.S. AI companies’ models through industrial-scale knowledge distillation campaigns that form the core—not merely a supplement—of their AI development strategy,” the agencies wrote. 
    • “The advisory names Chinese companies like DeepSeek, Moonshot AI, Alibaba, MiniMax, StepFun, and Z.AI, saying they spent billions of tokens across millions of exchanges and requests with frontier U.S. AI models like Anthropic’s Claude, OpenAI’s ChatGPT, Google Gemini, and xAI’s Grok, since at least late 2024.”
  • The Justice Department made available “Remarks by Deputy Assistant Attorney General Josh Goldfoot of the Justice Department’s Criminal Division at the International Symposium on Cybercrime Response” held in Seoul, Korea.
  • Beckers Health IT notes,
    • “A Ukrainian national who helped deploy Conti ransomware against more than 1,000 victims worldwide has been sentenced to four years in prison for conspiracy to commit wire fraud.
    • “Oleksii Oleksiyovych Lytvynenko, 44, formerly of Cork, Ireland, admitted to joining the Conti operation and coding a “loader” — malware used to deliver other malicious software onto compromised systems, according to a Sept. 10 U.S. Justice Department news release. He pleadedguilty June 10.
    • “Conti attacked computers and networks in 47 states, the District of Columbia, Puerto Rico and 31 countries between 2020 and 2022, and the FBI estimates the group collected more than $150 million in ransom payments. Evidence from Mr. Lytvynenko’s online accounts showed he possessed data stolen from eight U.S. victims and four overseas victims. He was arrested in County Cork, Ireland, in July 2023.”

From the cybersecurity breaches and vulnerabilities front,

  • HIPAA Journal released its June 2026 Healthcare Data Breach Report.
    • “In June 2026, 66 large healthcare data breaches – data breaches involving the protected health information of 500 or more individuals – were reported to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) – a slight increase from the 64 data breaches reported in May. More than two large data breaches a day is the new normal. Over the past 12 months, an average of 65 large healthcare data breaches have been reported per day; eight years ago in 2018, large healthcare data breaches occurred at a rate of around one per day.”
  • Beckers Health IT reports,
    • “Houston-based Nutex Health says the hackers behind its August cyberattack have published the data they allegedly stole on their own website.
    • “The publicly traded micro-hospital operator is now downloading, processing and analyzing that data to determine its contents, scope and authenticity, according to a Sept. 10 SEC filing. Nutex said the review could take several weeks given the volume of data involved.” * * *
    • “Nutex said it has not identified any material impact on its business operations or financial reporting systems, and its materiality assessment from the Aug. 31 filing remains unchanged. The company said it continues to evaluate regulatory and legal notification requirements and intends to notify affected patients and employees.
    • “Several purported class action lawsuits have been filed against Nutex in the U.S. District Court for the Southern District of Texas’ Houston Division on behalf of individuals whose personal or health information was allegedly accessed. Nutex said it cannot predict the litigation’s outcome or its potential financial impact.”
  • and
    • “Annapolis, Md.-based Luminis Health’s phone system and MyChart patient portal remain unavailable as the health system continues responding to a cybersecurity incident involving an unauthorized criminal actor.
    • “In a Sept. 10 update, Luminis Health said its investigation is ongoing and teams are working with third-party experts to safely restore affected systems.
    • “The health system said its hospitals remain open and continue providing patient care.”
  • and
    • Recent cybersecurity warnings and incidents are highlighting risks for healthcare organizations that extend beyond ransomware, including cloud authorization abuse, voice phishing, brand impersonation, third-party access and publicly exposed information.
    • [The article describes] five recent cybersecurity developments Becker’s has reported on in September.]
  • Security Week adds,
    • “More than 4.1 million individuals had their personal, health, and insurance information stolen in a data breach at healthcare company AdaptHealth.
    • “Operating over 680 facilities across the US, AdaptHealth describes itself as a network of medical equipment companies that provides patients with healthcare solutions and medical equipment.
    • “The company was hacked in early June, when a threat actor gained access to its cloud-based applications, including internal systems used for patient management and document storage.
    • “After the attacker contacted the company, it confirmed the data breach, including the theft of a password file associated with insurance billing.
    • “The hacker used social engineering to compromise a user session at a third-party contractor, AdaptHealth said.”
  • and
    • “Future phishing campaigns may no longer involve a detectable physical web page.
    • “Barracuda has analyzed a new type of phishing campaign that adds both stealth and flexibility to traditional phishing. Rather than standard social engineering to persuade a target to visit a static compromised web page, this campaign generates a blob URL to render and deliver the phishing page inside the target’s own browser. This reduces the possibility of security scanners detecting either the social engineering email or the static residence of the phishing page.”
  • HIPAA Journal lets us know,
    • “Three high-severity vulnerabilities have been identified in NextGen Healthcare Mirth Connect (Mirth Connect), a cross-platform healthcare integration engine for connecting, routing, transforming, and exchanging clinical and administrative data between different healthcare systems. The vulnerabilities are due to improper neutralization of special elements used in SQL commands and improper restriction of XML External Entity Reference. Successful exploitation of the vulnerabilities could allow denial-of-service attacks and data exfiltration.
    • “The vulnerabilities were identified by security researcher Abhinav Agarwal using autonomous agents running his published methodology on AI-assisted vulnerability discovery. “Mirth Connect is effectively a switchboard between healthcare systems. It can sit between lab systems, imaging systems, databases, and clinical applications, so a vulnerability in the integration layer can expose much more than one isolated application,” Agarwal told The HIPAA Journal. A potential problem is that healthcare organizations may not know that they have a vulnerable component in one of their products. “A hospital may not see the name Mirth anywhere on the product it bought. Integration software can be managed, resold, or embedded inside another product, which is why SBOMs and exact version disclosure matter after vulnerabilities like these,” explained Agarwal.”
  • CISA added 14 known exploited vulnerabilities to its catalog this week.
    • September 8, 2026
      • CVE-2026-75650 Adobe Commerce and Magento Improper Neutralization of Special Elements Used in a Template Engine Vulnerability
      • CVE-2026-81963 Microsoft Windows Link Following Vulnerability  
      • CVE-2026-85880 Microsoft Windows Heap-Based Buffer Overflow Vulnerability 
      • CVE-2026-86218 N-able N-central Static Code Injection Vulnerability
        • SOC Prime discusses the Adobe KVE here.
        • The Hacker News discusses the Microsoft KVEs here.
        • Cybersecurity Dive discusses the N-able KVE here. 
    • September 9, 2026
      • CVE-2025-25249 Fortinet Multiple Products Heap-based Buffer Overflow Vulnerability
      • CVE-2026-19490 Citrix NetScaler Authentication Bypass Using an Alternate Path or Channel Vulnerability
      • CVE-2026-87491 Google Chromium V8 Out of Bounds Write Vulnerability
      • CVE-2026-20079 Cisco Firewall Management Center Authentication Bypass Using an Alternate Path or Channel Vulnerability 
        • Security Week discusses the Fortinet KVE here.
        • Cybersecurity News discusses the Citrix KVE here.
        • SOC Prime discusses the Google KVE here.
        • The Cybersecurity Hub discusses the Cisco KVE here.
    • September 10, 2026
      • CVE-2026-67277 MikroTik RouterOS Missing Authentication for Critical Function Vulnerability
      • CVE-2026-86060 MikroTik RouterOS Improper Neutralization of Argument Delimiters in a Command Vulnerability
        • Bleeping Computer discusses these KVEs here.
    • September 11, 2026 (1)
      • CVE-2026-42016 JFrog Artifactory Incorrect Authorization Vulnerability 
      • CVE-2026-42018 JFrog Artifactory Improper Authentication Vulnerability 
      • CVE-2026-84869 ConnectWise ScreenConnect Improper Privilege Management and Missing Authorization Vulnerability
        • The Hacker News discusses the JFrog KVEs here.
        • Security Arsenal discusses the ConnectWise KVE here.
    • September 11, 2026 (2)
      • CVE-2026-85706. GitLab Community Edition and Enterprise Edition Path Traversal Vulnerability
        • Cyberscoop discusses this KVE here.
  • Dark Reading adds,
    • “A new analysis of public data from Anthropic’s Project Glasswing has highlighted a significant gap between the number of vulnerability findings generated by its Claude frontier model and those that ultimately prove to be real, serious, and worth fixing.
    • “The distinction matters because it suggests that the bottleneck in vulnerability research may increasingly lie in validating new flaws and coordinating their remediation rather than in discovering them.”
  • Security Week tells us,
    • “Anthropic disrupted a cyberespionage operation whose tradecraft and targeting match the Russian state-nexus group tracked as Midnight Blizzard, the company said in a threat intelligence report published this week. 
    • “The report covers activity the company identified and shut down between December 2025 and August 2026.
    • “According to Anthropic, Midnight Blizzard used Claude to monitor how well its malware evaded detection by security products. When a tool was flagged, AI agents automatically modified and rebuilt it, then redeployed it, repeating the process until the malware went undetected again.”

From the ransomware front,

  • The Hacker News reports,
    • “Cisco has revealed that three distinct threat clusters linked to ransomware and state-sponsored attacks have been exploiting two recently patched Secure Firewall Management Center (FMC) vulnerabilities.
    • “The attacks leverage CVE-2026-20079 (CVSS score: 10.0), an authentication bypass vulnerability in the web interface of FMC software that could allow an unauthenticated, remote attacker to bypass authentication and execute script files on an affected device to obtain root access to the underlying operating system.
    • “The second flaw under exploitation is CVE-2026-20316 (CVSS score: 5.3), which could allow an unauthenticated, remote attacker to log in to an affected device using a low-privilege account to access sensitive data within susceptible systems. It can be paired with other Cisco Secure FMC vulnerabilities to elevate privileges.” * * *
  • Cybersecurity Insiders relates,
    • “Ransomware attacks are becoming increasingly common, posing a serious threat to businesses across industries. A recent study conducted by Object First in collaboration with technology research firm Omdia highlights not only the growing frequency of these attacks, but also the increasing difficulty businesses face in recovering their data after an incident.
    • “According to the study, ransomware is having a significant impact on business operations. Over the past 24 months, around 84 percent of businesses surveyed admitted that file-encrypting malware had severely disrupted their operations. This represents a considerable increase from the previous year, when only 64 percent of businesses reported experiencing such disruption.
    • “The findings become even more concerning when it comes to data recovery. Only 39 percent of ransomware victims said they were able to recover at least 80 percent of their data following an attack. This is a sharp decline from the 57 percent reported the previous year. The figures indicate that businesses are not only encountering ransomware more frequently but are also finding it increasingly difficult to restore their systems and recover critical information.” * * *
    • “The decline in successful data recovery also highlights the importance of preparedness. Simply preventing an attack is no longer enough. Organizations need comprehensive backup and recovery strategies that can help them restore critical systems quickly in the event of a successful breach. Regularly tested backups, robust access controls, employee awareness training and well-defined incident-response plans can all play an important role in reducing the damage caused by ransomware.
    • “The latest findings suggest that ransomware has evolved into a broader business continuity challenge. As attacks become more frequent and sophisticated, organizations must focus equally on prevention, detection and recovery. Investing in resilient infrastructure and reliable data protection could prove crucial in ensuring that a ransomware incident does not turn into a prolonged business crisis.”
  • Help Net Security adds,
    • “In this Help Net Security video, Kerri Shafer-Page, VP of Incident Response at Arctic Wolf, walks through the ransomware decision tree in this video. She covers four areas where decisions need settling in advance, starting with containment.
    • “Someone has to know the network well enough to judge what pulling a system offline does to client data, a manufacturing line, or a website. Then comes the extortion demand. Who is authorized to negotiate, and what is the ceiling?
    • “Shafer-Page treats paying as a business decision, noting that a demand can cost less than an insurance retention and higher renewal rates. She argues law enforcement belongs in the playbook, since agencies may know the threat actor and can help you avoid sanctions problems.
    • “Communication matters too, from cyber legal counsel on disclosure deadlines to a spokesperson and a prepared help desk. Her advice: make these decisions on a Tuesday afternoon, not at 2 a.m. on a holiday weekend.”
  • and
    • “In this Help Net Security video, Dave Ross, Senior Director of the Intelligence Fusion Team at Intel 471, explains what happens behind the scenes during ransomware negotiations.
    • “Ross walks through the tactics groups use once an attack begins, from research on a victim’s revenue and insurance coverage to test decryptions that prove they hold a working key.
    • “He describes how demands are often set at roughly 1% to 5% of annual revenue, why deadlines move depending on how a victim responds, and how some groups split work between researchers, negotiators, and staff who apply public pressure.”

From the cybersecurity business and defenses front,

  • Cryptobriefing reports,
    • “Tenable Holdings is embedding Anthropic’s Claude Mythos 5 directly into its flagship cybersecurity product, betting that frontier AI models can fundamentally change how organizations spot and neutralize threats before attackers exploit them.
    • “The integration, announced on September 8, 2026, will bring AI-driven exposure analysis and attack-path discovery into the Tenable One Exposure Management Platform. The first concrete feature shipping under this effort is called Tenable One Adversary View, which uses Claude Mythos 5 to reconstruct how an attacker could move from an initial foothold all the way to an organization’s most critical systems.”
  • Per MedTech Dive,
    • “Boston Scientific disclosed Tuesday the cyberattack that recently hit the company is likely to affect third-quarter and full-year results.
    • “The medical device maker believes it is unlikely to meet net sales growth and adjusted earnings per share guidance ranges provided in July for the third quarter and full year, according to a new filing with the Securities and Exchange Commission.
    • “The Company anticipates recovering some portion of the impacted revenue as it continues to ramp operations globally, fulfill customer orders and reduce remaining backlogs, however the full impacts are not yet known,” Boston Scientific said in the filing.”
  • Cybersecurity Dive relates,
    • “After suffering a series of high-profile cyberattacks over the past decade, Microsoft says a new initiative to reinvigorate its security culture is bearing fruit.”
  • and
    • “Chief information security officers are largely expected to ensure the security of AI across the enterprise, but many say they are not receiving adequate support, according to findings from Proofpoint. 
    • “About 85% of CISOs said ensuring the safe use of AI assistants, copilots and automation is a top priority over the next two years, according to Proofpoint’s annual Voice of the CISO report. Eight of every 10 CISOs said they are expected to manage AI-related security risks without receiving a proportional increase in resources or expertise. 
    • “CISOs have a significant role to play in securing AI adoption, but they can’t own the risk alone,” Patrick Joyce, global resident CISO at Proofpoint, told Cybersecurity Dive. “AI is being adopted across the business, often faster than traditional governance models can keep up.”
  • and
    • “Advances in artificial intelligence aren’t changing the fact that simple cybersecurity failures remain the most consequential, government and industry leaders warned on Tuesday.
    • “What will prevent the attacks in the next 18 months are the same things that would have prevented the attacks of yesterday,” Jason Bilnoski, a deputy assistant director in the FBI’s Cyber Division, said during a panel here at the Billington Cybersecurity Summit.
    • “Core practices such as identity management, perimeter monitoring, cyber hygiene and strong multifactor authentication remain as essential as ever, Bilnoski said.
    • “Speed and capability is certainly increasing with the use of AI, but the end state is still the same,” he said. “How actors are compromising, whether it’s criminal or nation-state, still stays the same.”
  • HIPAA Journal tells us,
    • “The HHS has released an updated version of the Security Risk Assessment (SRA) Tool (v3.7). The tool is ideally suited for small- and medium-sized entities to guide them through the risk analysis process, help them identify risks and vulnerabilities to electronic protected health information (ePHI), and comply with the risk analysis implementation specification of the Security Management Process standard of the HIPAA Security Rule.”
  • CISA has released the 2026 edition of its Insider Threat Mitigation Guide.
    • “The Cybersecurity and Infrastructure Security Agency’s Insider Threat Mitigation Guide aids critical infrastructure stakeholders in comprehending the concept of insider threats, identifying the various forms these threats can take, and implementing best practices to establish or enhance an insider threat mitigation program. Such a program is essential for protecting critical assets, deterring violence, countering unintentional incidents, preventing loss of revenue or intellectual property, averting the compromise of sensitive data, and ultimately saving lives.”
  • Healthcare IT News informs us,
    • “Devices and sensors that collect heart rate and other health data and rely on applications to share information with third parties pose serious questions about data protection for patients and the health systems that care for them.
    • “While smart ring and watch data might help doctors treat patients, security experts say low security standards in consumer tech and improperly configured APIs present potential security risks for providers.
    • “Hackers can exploit such flaws, using consumer devices as entry points to breach receiving electronic health record systems and access centralized databases.
    • “To mitigate these threats, security experts say healthcare organizations must establish strict security protocols, including mandatory transit encryption, multi-factor authentication and account monitoring. They recommend zero-trust approaches to catch rogue traffic and implementation of rigorous engineering frameworks.”
  • Here’s a link to Dark Reading’s CISO Corner.