Friday report

David Ermer

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

Friday report

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

Simplicity is a virtue.

From Washington, DC

  • The Hill reports,
    • “Bipartisan House lawmakers, including two battleground Republicans, introduced legislation Thursday to ensure people with private health insurance don’t pay more than $35 a month for insulin. 
    • “Lawmakers have discussed the idea of an insulin cap for years but haven’t been able to get legislation over the finish line over GOP resistance to government setting prices.  
    • “But two Republicans in contested battleground districts signing on shows that the GOP is trying to address concerns about the cost of healthcare ahead of the midterm elections.  
    • “The Insulin Act — shorthand for the Improving Needed Safeguards for Users of Lifesaving Insulin Now Act — was introduced by Reps. Diana DeGette (D-Colo.), Angie Craig (D-Minn.), Kim Schrier (D-Wash.), Mariannette Miller-Meeks (R-Iowa) and Rob Bresnahan (R-Pa.). 
    • “It’s a companion version of legislation that advanced through the Senate Health Committee earlier this summer. That bill is being pushed by Sens. Susan Collins (R-Maine), Jeanne Shaheen (D-N.H.), Raphael Warnock (D-Ga.) and John Kennedy (R-La.). In total, it has 28 co-sponsors divided equally between the parties.” 
  • Beckers Payer Issues relates,
    • “House Democrats are discussing a healthcare policy agenda that could include an expansion of the Medicare program, the Washington Post reported Sept. 3.
    • “House Minority Leader Hakeem Jeffries told NBC News that reversing the Medicaid cuts under H.R.1 and reviving enhanced ACA premium tax credits have “uniform Democratic support” ahead of the midterms. But privately, members have been discussing a broader expansion of Medicare, including widening eligibility, adding new benefit categories and capping enrollee costs, as well as creating some form of public insurance option, according to the Post, citing four people familiar with the discussions. 
    • “Breaking up vertically integrated healthcare companies like UnitedHealth Group and CVS Health is also under discussion, the Post reported, mirroring a theme that has drawn bipartisan support in Congress since January’s hearings with the CEOs of major insurers.
    • “Other policy ideas Democrats are reportedly looking at are cracking down on Medicare Advantage billing practices they say are fraudulent, expanding Medicare’s authority to negotiate drug prices beyond the current scope under the Inflation Reduction Act, passing a federal right to abortion and providing public coverage to people up to 26 years old.”
  • and
    • “CMS has rebranded individual coverage health reimbursement arrangements to CHOICE Arrangements, or Custom Health Option and Individual Care Expense.
    • “The new name for the alternative health insurance model was announced Sept. 3 by CMS Administrator Mehmet Oz, MD, at an event in Indiana.
    • “ICHRAs let employers give workers a fixed, tax-free amount to buy their own individual health insurance on or off the exchange instead of offering a traditional group plan. The number of people covered by ICHRAs surpassed 500,000 at the start of 2026, according to the HRA Council.”
  • Beckers Hospital Review adds,
    • “States are earmarking specific slices of their Rural Health Transformation Program dollars for technology upgrades, service expansions and workforce pipeline development.
    • “[As noted in the FEHBlog] CMS has announced 15 such efforts over the past month. Each state’s full fiscal year 2026 award was set in December 2025, when CMS approved $50 billion in Rural Health Transformation Program funding across all 50 states. The entries below represent specific initiatives or sub-awards within those existing awards — not new money on top of them.
      • New York — $76 million. CMS said Sept. 4 the funding will strengthen coordination among rural hospitals, primary care providers, federally qualified health centers and behavioral health providers, and expand clinical training programs for the rural workforce.
      • Michigan — $25 million. The funding will modernize healthcare technology, expand telehealth and remote patient monitoring capabilities, and improve high-speed internet connectivity in rural areas, according to a Sept. 4 news release. 
      • Rhode Island — $5.48 million. CMS announced Sept. 4 that the funding will expand career and technical education in healthcare fields at 14 local education agencies and schools, building student pathways into nursing, EMS, behavioral health and other high-demand professions.
  • Per a Department of Health and Human Services news release ,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today awarded $11.2 million to support the development of 15 new physician residency programs in rural communities across 14 states. The Rural Residency Planning and Development (RRPD) Program awards will create new residency programs in family medicine, internal medicine, preventive medicine, psychiatry, and general surgery, helping to strengthen the health workforce in rural and tribal communities.
    • “Where you live should not determine whether you can find a doctor,” said HHS Secretary Robert F. Kennedy, Jr. “We are bringing physician training directly into rural and tribal communities, where doctors are needed most. By training physicians in these communities, we can build a stronger local workforce, expand access to care, and ensure rural families can get the care they need close to home.”
    • “Since the RRPD program was established in 2019, HRSA has invested nearly $77 million across 36 states and one territory to build a pipeline of physicians trained in rural communities. As of July 2026, these investments have resulted in 66 accredited rural residency programs, 818 approved residency positions, and more than 850 resident physicians enrolled in rural training settings.”

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

  • Federal News Network reports,
    • “Agencies may get more flexibility in disciplining federal employees, after the Merit Systems Protection Board finalized a rule ending decades-old standards for reviewing misconduct cases.
    • “MSPB on Thursday lifted a requirement to consider the “Douglas factors” in every employee misconduct case — 12 considerations the board has used for the last 45 years to determine whether a penalty, such as a firing or demotion, was reasonable.
    • “Once the final rule takes effect in 30 days, MSPB will evaluate whether an agency’s penalty for an employee accused of misconduct was reasonable on a case-by-case basis rather than reviewing all 12 considerations listed under the Douglas factors.
    • “Stemming from a 1981 Department of Veterans Affairs case, MSPB has relied on the Douglas factors in reviewing misconduct appeals, looking at the seriousness of the offense, the employee’s disciplinary record, and the potential for the employee to be rehabilitated, among other considerations.”
  • and
    • “Federal employees traveling for business will see a slight bump in their daily reimbursable allowance, according to new per diem rates set by the General Services Administration.
    • “Starting Oct. 1, employees on official travel will see a $3 increase in the standard lodging per diem rate, from $110 to $113, GSA announced last month. Allowances for meals and incidental expenses (M&IE) will remain between $68 and $92 for the upcoming fiscal year, with the lower end of that range serving as the standard base rate.
    • “Agencies use per diem rates to reimburse federal employees for lodging, meals and other expenses during official travel. GSA announces the government’s per diem rates each August, ahead of the upcoming fiscal year.”

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns who cannot receive nutrition by mouth or through a feeding tube.
    • “The FDA became aware of the potential supply gap after children’s hospitals raised concerns about continued access to neonatal starter parenteral nutrition. The concerns were based on the discontinuation of certain standardized neonatal starter PN products made by two outsourcing facilities that are permanently shutting down.
    • “The FDA is committed to deploying every regulatory tool available to prevent critical supply chain gaps from threatening patient care,” said Acting FDA Commissioner Kyle Diamantas, J.D. “We are working closely with healthcare providers and industry partners to help ensure that vulnerable populations continue to have access to the care they need.”
  • and
    • “The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.
    • “FDA granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy, based on an FDA-authorized test.
    • “ESR1 mutations are acquired resistance mutations that a tumor may develop during treatment with an aromatase inhibitor, a type of endocrine therapy that is a common front-line treatment for locally advanced or metastatic breast cancer. At the diagnosis of HR-positive metastatic breast cancer, fewer than 5 percent of patients will have this tumor mutation. After disease progression on an aromatase inhibitor, nearly 40 percent of patients will have this tumor mutation.
    • “Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment. We owe them every weapon in our arsenal.” said Acting FDA Commissioner Kyle Diamantas, J.D. “Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”
  • Cardiovascular Business relates,
    • “Powerful Medical, a New York-based medtech company, has been granted De Novo authorization from the U.S. Food and Drug Administration (FDA) for an artificial intelligence (AI) model designed to detect signs of an ST-elevation myocardial infarction (STEMI) in electrocardiography results.
    • “The newly authorized AI model, Queen of Hearts, can flag STEMI as well as STEMI equivalents. It was trained by Stephen W. Smith, MD, an emergency physician at Hennepin County Medical Center. The technology already gained European CE mark approval and it received the FDA’s breakthrough device designation in March 2025. Approximately seven months later, new data on Queen of Hearts was presented at TCT 2025 in San Francisco and simultaneously published in JACC: Cardiovascular Interventions.[1] That study linked the advanced AI model to a significant improvement in heart attack detection and a reduced risk of false-positive alerts.
    • “With this FDA authorization in place, Powerful Medical is now ramping up the deployment of its PMcardio platform, which can embed Queen of Hearts—and other algorithms when desired—into existing clinical workflows.” 

From the judicial front,

  • Per a Department of Justice news release,
    • “Two Florida men were sentenced to multiple years in prison for their roles in a $34.8 million health care fraud conspiracy billing Medicare for thousands of orthotic braces sent to Medicare beneficiaries who did not need them.
    • “These fraudsters billed Medicare $34.8 million for braces that patients didn’t need and didn’t request — and now they’re paying the price,” said Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division. “They paid kickbacks for fake doctors’ orders, shuffled billing among several companies to dodge payment suspensions, and pocketed millions that belonged to American taxpayers. Their prison sentences make clear: if you steal from Medicare, you will be caught, you will be prosecuted, and you will be held accountable.”
    • “According to court documents, Kenneth Charles Kessler III, 43, of Miami, Florida, and Michael Andrew Gomez, 43, of Miramar, Florida, owned and operated seven durable medical equipment (DME) supply companies based in Florida. Through these DME companies, they submitted millions of dollars in false claims to Medicare for medically unnecessary orthotic braces.
    • “Kessler and Gomez also paid illegal kickbacks and bribes to obtain fraudulent signed doctors’ orders. They used these orders to ship orthotic braces to Medicare beneficiaries nationwide, including to beneficiaries who neither requested nor needed the braces, and then claimed payment for those braces from Medicare. Kessler and Gomez used their multiple DME companies to evade Medicare payment suspensions by shifting their fraudulent billing between their DME companies.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 4, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
      • “National and regional COVID-19 activity is increasing.
      • “RSV activity is very low in most areas of the country.
      • “Seasonal influenza activity is low.
      • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
  • Yahoo adds,
    • “As the most up-to-date vaccines are set to come out, Texas has experienced rising rates of COVID infection, data suggests. 
    • “Wastewater COVID readings in Texas have surged well beyond the national average, starting in July, according to data from the Centers for Disease Control and Prevention. 
    • “The state’s wastewater viral activity level hovered a little above the U.S. average through most of June. It crested twice in the summer before reaching the CDC’s “very high” threshold during the week ending Aug. 22, the latest date for which data is available. 
    • “Texas was the only state in the nation with “very high” wastewater COVID levels as of Aug. 22. Wastewater data can alert public health officials to rising illness beyond other indicators, like positive test rates, ER visits and deaths, which have limitations due to how they’re collected.”
  • Per a Walgreens news release,
    • “Walgreens is now offering 2026-2027 COVID-19 vaccines for eligible patients.1 With multiple viruses and seasonal illnesses expected to circulate this fall and winter, Walgreens is making it easy for patients to stay protected by offering COVID-19, flu, RSV, pneumococcal and other recommended vaccines during a single visit. 
    • “Patients can walk into their local Walgreens pharmacy or schedule an appointment at Walgreens.com/ScheduleVaccine, through the Walgreens app, by texting “Flu” to 66879 or by calling 1-800-WALGREENS in most states. 
    • “As respiratory virus season ramps up, many people are thinking about how to protect themselves and their loved ones,” said Rick Gates, chief pharmacy officer, Walgreens. “Getting multiple recommended vaccines at the same time is a safe and effective way to reduce the risk of illness and help protect yourself, your family and your community heading into the fall and winter. Our goal is to make getting vaccinated as convenient as possible so patients can save time and stay protected.” 
  • MedPage Today tells us,
    • “Viral persistence is thought to be a possible cause of long COVID.
    • “In this phase II trial, nirmatrelvir-ritonavir (Paxlovid) — which is approved for acute COVID-19 — was no better than placebo-ritonavir at reducing long COVID symptoms.
    • “The NIH-sponsored study included participants with cognitive, autonomic, and exercise phenotypes.”
  • The University of Minnesota CIDRAP reports,
    • “Today, the CDC updated the country’s measles case count, which stands at 3,134, including the two Pennsylvania deaths. Eight percent of measles patients have been hospitalized. 
    • “Of the total, 231 infections are new. That compares with 126 new cases last week.
    • “Of all cases, 94% occurred in people who were unvaccinated or had an unknown vaccination status. All cases but 16 were locally transmitted. In all of 2025, 2,289 measles case were confirmed in the United States.
    • “In Pennsylvania, officials today added 115 new cases—about half of all new US infections—from the past week to its state case tally, raising it to 577 cases. None of the state’s cases involve people fully vaccinated against the virus. In total, 98 people (17%) have been hospitalized. Thirty percent of infections occurred in children.
    • “The Pennsylvania Department of Health also warned that travelers at the New Stanton Service Plaza on the westbound Pennsylvania Turnpike in Westmoreland County may have been exposed to measles by a person from another state who stopped at the plaza on August 17 and later tested positive for the virus.
    • “On the cusp of the Labor Day weekend, which entails travel for many people, healthcare professionals are urging travelers to be vigilant in monitoring for symptoms of the highly contagious disease, such as rash, fever, and red, watery eyes.
    • “Ohio is reporting 15 new cases, including five cases in Wayne County, amid its third measles outbreak of the year, raising its tally for the year to 122.” 
  • and
    • “For the fourth year in a row, the number of US teenagers being vaccinated against human papillomavirus (HPV) has not increased, according to survey results published yesterday in Morbidity and Mortality Weekly Report. 
    • “A smaller percentage of adolescents received the HPV series compared with recipients of the tetanus, diphtheria, and pertussis (whooping cough) vaccine (Tdap) and the conjugate meningococcal vaccine against the A, C, W, and Y strains (Men ACWY). But uptake of these immunizations declined slightly from last year. 
    • “The consistently lower HPV vaccination coverage compared with other routine adolescent vaccines might, in part, reflect differences in school entry requirements,” wrote the authors, from the Centers for Disease Control and Prevention (CDC). “Tdap is required for school entry in all states, and MenACWY is required in most states; however, few states require HPV vaccination.” * * *
    • “Continued efforts are needed to increase adolescent vaccination coverage with recommended vaccines and reduce geographic differences in coverage, particularly with HPV vaccine,” the authors wrote. “Efforts to address barriers to vaccination, including improving access to preventive care, strengthening provider communication regarding recommendations, and increasing vaccine confidence, could help improve coverage.”
  • The Washington Post offers a look at “The behind-the-scenes effort to contain the nation’s worst ongoing measles outbreak.”
    • Public health workers are relying on word of mouth to fight the largest ongoing outbreak in the United States.
  • Beckers Clinicial Leadership informs us,
    • “Two patients who received genetically engineered pig kidney transplants at Somerville, Mass.-based Mass General Brigham have since successfully undergone human donor kidney transplants, Cambridge, Mass.-based eGenesis said in a Sept. 3 update on its Expanded Access program.
    • “The cases mark the first reported transitions from xenotransplantation to allotransplantation, according to eGenesis, and provide early evidence that a genetically engineered pig kidney can bridge patients to a human donor organ.”
  • and
    • “Death rates from cancers associated with alcohol consumption doubled between 1990 and 2023, according to a study published Sept. 2 in The Lancet Regional Health — Americas. 
    • “Led by the Sylvester Comprehensive Cancer Center at the University of Miami, researchers used the Global Burden of Disease database to analyze age-standardized mortality rates for all cancers and 10 specific cancers, and the percentage of those rates that could be attributed to heavy alcohol use, between 1990 and 2023.”
  • Health Day points out,
    • “A person’s memory starts to get worse much sooner than previously thought, a new study says.
    • “Folks in their 50s start showing signs of decreased memory function, likely due to changes in the brain region responsible for stabilizing memories, researchers reported recently in the journal Cerebral Cortex.
    • “This is one of a growing list of studies highlighting that the period of middle age is really important for memory functioning and shouldn’t be ignored,” senior researcher Ian McDonough, an associate professor of psychology at Binghamton University in New York, said in a news release.”
  • and
    • “Simple walking tests could be an easy way to assess the well-being of a patient with multiple sclerosis (MS), a new study says.
    • “Better walking performance and higher levels of daily physical activity are linked to better quality of life among people with intermittent forms of MS, researchers report in the October issue of the journal Multiple Sclerosis and Related Disorders.
    • “These findings reinforce previous research and highlight the potential benefits of maintaining an active lifestyle,” lead author Marko Luostarinen, a doctoral researcher at the University of Eastern Finland, said in a news release.”
  • Per BioPharma Dive,
    • “AbbVie said its dual-acting drug for multiple myeloma met the main goal of a Phase 3 clinical trial, helping people who’ve progressed on two or more lines of therapy survive longer without progression than those who received standard treatment regimens, the company said Thursday.
    • “The drug, called etentamig, could be safer than rival drugs launched by Johnson & Johnson, Pfizer and Regeneron, with low rates of two kinds of serious immune responses common to other drugs of its type. AbbVie said its safety profile could enable greater use in community oncology centers because of reduced need for post-treatment patient monitoring.
    • “Etentamig is a type of drug called a bispecific antibody that can simultaneously bind to diseased tumor cells and T cells, triggering an immune response to fight multiple myeloma. It trails by more than four years the first drug in its class, J&J’s Tecvayli, which booked $462 million in sales through the first six months of 2026.”
  • The Wall Street Journal notes,
    • “Bristol Myers Squibb told regulators, researchers and patient-advocacy groups in early June that it had paused closely watched drug research because of life-threatening side effects. It took three months for the company to share that with the broader public.
    • “Novartis paused research into a similar therapy last month, which it confirmed only after a Wall Street analyst noticed while scouring a database. It took a week for the company to reveal that three study patients had died.
    • “Novartis and Bristol Myers are both studying their own new forms of faster-to-produce CAR-T therapy for autoimmune diseases, a promising new area of drug research that re-engineers a person’s own cells to attack disabling conditions such as lupus or rheumatoid arthritis.”
  • Per Genetic Engineering and Biotechnology News,
    • “A cancer drug designed to push malignant cells toward death may also help researchers chip away at one of the toughest barriers to curing HIV: the long-lived viral reservoir that persists despite antiretroviral therapy.
    • “In a study titled, “BCL-2 inhibition at antiretroviral therapy initiation reduces the intact SIV reservoir in macaques,” and published in Nature Microbiology, researchers at Emory University reported that a short course of venetoclax, a BCL-2 inhibitor approved for certain blood cancers, reduced the intact simian immunodeficiency virus (SIV) reservoir in rhesus macaques when given at the start of antiretroviral therapy (ART). SIV infection in macaques is commonly used as a nonhuman primate model for studying HIV persistence and cure strategies.”

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

  • Modern Healthcare reports,
    • “Cambia Health Solutions’ strategic affiliation with Arkansas Blue Cross and Blue Shield has been approved by state regulators.
    • “The deal will take effect Oct. 1, according to a Friday news release from the companies.
    • “Cambia, which operates Regence Blue Cross plans in Idaho, Oregon, Utah and Washington, in February completed a similar affiliation with Blue Cross Blue Shield of North Dakota.
    • “Arkansas Blue Cross will retain its regional brand name, local board and philanthropic foundation, and its reserve funds and foundation resources will stay in the state, according to the news release. 
    • “Curtis Barnett will remain president and CEO of Arkansas Blue Cross, with Jared Short still president and CEO of Cambia, a Cambia spokesperson said Friday. No assets will be transferred.
    • “The affiliation will enable the companies to pool resources and develop new technology and care management services, executives said in November.” 
  • The Wall Street Journal relates,
    • “Most people do not appeal health insurers’ prior authorization denials, even though many who do are successful.
    • “Successful appeals require doctors to provide precise diagnosis details and authoritative medical information to counter insurer objections.
    • “Patients can appeal denials for drugs not on a formulary list or for step therapy requirements by providing medical records.”
  • Beckers Hospital Review tells us,
    • “Lebanon, N.H.-based Dartmouth Health recorded an operating loss of $22.9 million (-2% operating margin) in the third quarter of fiscal year 2026, compared to operating income of $47.7 million (4.3% margin) during the same period last year, according to its Aug. 28 financial report. ” * * *
    • “Dartmouth-Hitchcock Medical Center — its flagship hospital — has implemented a financial resiliency plan aimed at increasing patient access and reducing costs to improve its ongoing operating margin. The system engaged an external consultant in the second half of fiscal year 2026 to accelerate the plan and identify additional margin opportunities systemwide.”
  • Beckers ASC Review informs us,
    • “CMS’ 2026 Hospital Outpatient Prospective Payment System and ASC Payment System Final Rule marked the largest single-year expansion of outpatient-eligible surgery since at least 2018, surpassing, in one year, the 59 procedures Becker’s tracked as added to the ASC-covered list over the entire five-year span from 2018 to 2023. 
    • “Two policy changes drove it: a revision of the ASC covered procedures list criteria, and the start of a three-year phase-out of the inpatient-only list. CMS finalized the addition of 289 surgical procedures to the ASC covered procedures list for CY 2026, and separately added 271 of the codes removed from the inpatient-only list to that same list. Combined, more than 500 procedures became newly eligible for the outpatient/ASC setting in a single year.
    • [The article provides] a breakdown of the newly eligible procedures by specialty.
  • Healthcare Innovation lets us know,
    • “A five-year reimbursement horizon allows health systems to plan and invest in building comprehensive Hospital at Home programs.
    • “Workforce development and training are identified as major challenges, requiring new curricula and integration into the healthcare workforce.
    • “Technology must be designed around patient needs, with passive data capture and seamless EHR integration being key priorities.
    • “Implementation science is crucial to understanding why some programs scale successfully while others remain small.
    • “Hospital at Home is not suitable for all patients; careful patient selection and problem-focused planning are essential for success.”
  • Healthcare Dive points out,
    • “Adena Health has acquired Fairfield Medical Center, months after federal regulators scrutinized its previous planned merger with OhioHealth, the state’s largest health system.
    • “The Federal Trade Commission said Fairfield and OhioHealth scrapped their merger plans after an investigation concluded that a merger between the two systems would violate antitrust guidelines and negatively affect the quality and cost of care.
    • “Now, federal regulators are praising Fairfield’s new deal, which closed on Tuesday. “Today’s announcement should serve as a reminder that we will stop bad hospital deals,” Daniel Guarnera, Director of the Federal Trade Commission’s Bureau of Competition said in a Wednesday statement.”
  • Per Fierce Pharma,
    • “Total prescriptions for Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo both grew over the past week, reaching roughly 181K (+3%) and 44K (+8%), IQVIA data showed, as cited by Citi. Both numbers are the two meds’ highest so far. 
    • “While Foundayo has yet to catch up with the Wegovy pill, the market share gap between the two oral drugs is slowly narrowing. According to an Aug. 28 Jefferies note based on data the previous week, Foundayo’s share of new prescriptions (NRx), which exclude refills, was 21.5% in the oral obesity market.
    • “Back to the most recent week, the Wegovy pill’s position within the Wegovy family remained stable at 35%, as total Wegovy scripts increased 2.7% sequentially to 513.5K. During the same period, Lilly’s Zepbound scripts climbed 1.6% to a little fewer than 772K.” 

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “House Republicans are scrapping the last two weeks the chamber was scheduled to be in session before the midterm elections.
    • “Under the revised schedule announced Thursday, the House will return for votes the evening of Monday, Sept. 14, a week after Labor Day, for what is now expected to be only a one-week session before members return to their home districts.
    • “President Donald Trump signed a stopgap spending bill on Wednesday that will keep the government open through Dec. 11, which some argue has essentially negated the need for an extended September session. 
    • “I don’t think there’s any probably compelling reason that we need to be here” late in the month, said Rep. Robert B. Aderholt, R-Ala., a House appropriator.
    • “I think everybody’s so focused on the election at this point that we’ll just have to wait till the election’s over,” he added, when asked about passing more of the House’s fiscal 2027 spending bills.”
  • FEHBlog observation — September 14 also is the first day that the Senate returns from its State work break.
  • Fierce Healthcare relates,
    • “A leading Democrat in the House is probing the behavior of No Surprises Act arbiters.
    • Energy and Commerce Committee Ranking Member Frank Pallone, D-New York, sent letters to six certified independent dispute resolution (IDR) entities, seeking details on how each of them is conducting arbitration and staying in compliance with the law as IDR payouts rise.
    • “Pallone’s office sent letters to C2C Innovative Solutions, Inc.; Commence; Dane Street, LLC; EdiPhy Advisors, LLC; National Medical Reviews, Inc.; and ProPeer Resources, LLC on Thursday, per an announcement.
    • “In the letters, he notes the rising number of surprise medical bills that are reaching IDR, rather than being resolved in negotiations, and escalating payments for services resolved through arbitration. A study released in August by researchers at the Georgetown University Center on Health Insurance Reforms estimated that costs related to IDR reached $22.4 billion at the end of 2025.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $120 million investment is being delivered to strengthen rural health and expand access to high-quality care for Hoosiers through the federal Rural Health Transformation Program (RHTP). These investments will support locally driven solutions across eight regions of the state including removing barriers to technology, transportation, and health education. They will provide nutritional support and counseling with community-specific pilot programs that will address the impact food and nutrition have on health and healthcare. This funding will also help address prevention and management of chronic conditions such as diabetes and obesity.
    • “This investment will strengthen maternal and infant health services, expand access to primary and behavioral health care, and provide critical mental health and crisis response resources. It will also help build the next generation of the rural health workforce through expanded recruitment, training and retention efforts, while creating a coordinated transportation network to help patients get to the care they need.” 
  • Beckers ASC Review lets us know,
    • The Federal Trade Commission has widened its scrutiny of healthcare deal-making and dominant vendors over the past month, touching hospital M&A, ASC consolidation and the EHR  market in quick succession. 
    • [The article points out] three recent FTC moves to know.

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

  • Tammy Flanagan, writing in Govexec, discusses reliable rules for your retirement recordkeeping.
  • Ronald Sanders, a NAPA fellow, former OPM associate director and former agency CHCO, writing in Federal News Network, “explains why federal HR leaders should be treated like adults and held accountable.”

From the Food and Drug Administration front,

  • Eating Well reports,
    • “The FDA recalled 75,250 packages of Hodo’s Chili Crisp Lightly Fried Tofu due to potential contamination.
    • “The 8-ounce packages contain UPC 850565007842 and contain use-by dates from May 15 through November 7, 2026.
    • “The recall affects 29 states; check your fridge and return or dispose of affected tofu for a refund.
    • “The tofu may contain ink; seek medical care if you are experiencing any health concerns.”
  • Per FDA news releases,
    • “As part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation, the U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
    • “Botanical drug products are products that include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials and are intended to diagnose, cure, mitigate, treat or prevent disease. While there is broad interest in botanical products, their inherent complexity and variability can present unique challenges for research, product development and regulatory review.” * * *
    • “The public will have 60 days following publication in the Federal Register to submit comments to the docket. Stakeholders are encouraged to submit comments electronically at https://www.regulations.gov by searching for Docket No. FDA-2026-N-9550, entitled “Advancing Development of Botanical Drug Products; Request for Information.”  Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
    • “The comment period closes November 3, 2026.”
  • and
    • “The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients. Zanvastro is the first FDA-approved treatment for Alexander disease and the first therapy to directly target the protein buildup that drives the disease.
    • “For patients with Alexander disease and their families, there have been no approved treatment options — only supportive care while the disease progresses,” said Emily Freilich, M.D., Director of the Division of Neurology I in the FDA’s Center for Drug Evaluation and Research. “Today’s approval is a landmark moment for this community, offering the first therapy that addresses the underlying cause of this rare and serious disease.”
    • “Alexander disease is a rare, progressive neurological disorder caused by mutations in the gene that produces glial fibrillary acidic protein (GFAP). When this protein is abnormal, it accumulates in the brain’s supportive cells, causing damage to the nervous system over time. The disease affects less than 1 in a million people and can cause a wide range of serious and potentially life-threatening problems, including seizures, loss of developmental milestones, difficulty walking, muscle weakness, and increased pressure in the brain.
    • “Zanvastro is an antisense oligonucleotide — a type of medicine that works by reducing the production of the abnormal GFAP protein before it can accumulate and cause further damage. It is administered as an injection into the spinal canal every three months by a trained healthcare professional.”
  • Cardiovascular Business adds,
    • “Boston Scientific is warning clinicians about an ongoing safety concern with its LUX-Dx family of insertable cardiac monitors (ICMs). 
    • “The U.S. Food and Drug Administration (FDA) has classified the issue as a Class II recall. No patient injuries have been reported at this time. 
    • “According to Boston Scientific, no devices need to be returned or replaced. However, there are steps users can take to address the issue until it can be properly fixed.”
  • and
    • “Heartvue.ai, a medtech company based in Tennessee, has secured U.S. Food and Drug Administration (FDA) clearance for its new artificial intelligence (AI)-enabled imaging software that views, processes and evaluates cardiac MRI scans. Innolitics, an Austin-based consulting firm, helped guide Heartvue.ai through the regulatory process.
    • “The newly cleared software, Heartvue.Proton, uses advanced AI algorithms to automate measurements of 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification. Automating these measurements saves time, though each result is still reviewed and confirmed by a trained clinician. The software was designed to integrate with a hospital’s PACS or EHR system and slide right into any existing cardiology or radiology workflow.
    • “This clearance also includes a Predetermined Change Control Plan (PCCP), which helps Heartvue.ai make specific updates to this software without submitting additional requests to the FDA.”

From the public health and medical / Rx research front,

  • Per a CVS Health news release,
    • “CVS Health® (NYSE: CVS) today announced that updated 2026-2027 COVID-19 vaccines are now available at CVS Pharmacy® and MinuteClinic® locations for patients at no-cost with most insurance plans. Appointments are available at CVS.com, MinuteClinic.com and through the CVS Health® app, and walk-ins are accepted at CVS Pharmacy and MinuteClinic.
    • “We know patients value having convenient access to the vaccines and preventive care services they need,” said Amy Compton-Phillips, MD, Executive Vice President and Chief Medical Officer, CVS Health. “With updated COVID-19 vaccines available at CVS Pharmacy and MinuteClinic, we’re making it easier for people to get vaccinated close to home and on a schedule that works for them.”
    • “CVS Pharmacy offers COVID-19 vaccinations for eligible patients based on state regulations*, while MinuteClinic provides vaccinations for patients beginning at 18 months of age. Pharmacists and MinuteClinic providers are available to answer questions and help patients make informed decisions about vaccination based on their individual health needs.”
  • Nature reports,
    • “Just one week after the landmark US approval of a game-changing drug for advanced pancreatic cancer, the same therapy is showing promise against the world’s biggest cancer killer: lung cancer.
    • “In a small clinical trial of the drug daraxonrasib (Rasonque), tumours shrank in more than 30% of participants with the most common form of lung cancer, non-small-cell lung cancer. Each participant had a tumour-promoting mutation in a member of the RAS family of proteins, and had previously tried other therapies.
    • “We consider the results incredibly promising,” says Kathryn Arbour, a thoracic oncologist at the Memorial Sloan Kettering Cancer Center in New York City, and an author of the study, which was published on 2 September in the New England Journal of Medicine1. “These are exciting times.”
    • “A larger study in which participants with non-small-cell lung cancer are randomly assigned to receive either daraxonrasib or standard chemotherapy is under way. Regulators such as the US Food and Drug Administration (FDA) are likely to require results from that trial before approving the drug as a lung cancer treatment.”
  • Beckers Hospital Review interviews five health system leaders about their “plans to fast-track breakthrough pancreatic cancer drug.”
  • The New York Times relates,
    • “Can psilocybin, the hallucinogenic compound also known as magic mushrooms, inoculate cancer patients against the debilitating nerve damage caused by chemotherapy? At first blush, such an outcome might seem like wishful thinking.
    • “But a study published on Thursday in the journal Science makes a compelling case that administering psilocybin shortly before cancer treatments might prevent chemotherapy-induced peripheral neuropathy, a condition that affects about two-thirds of patients who receive chemo.
    • “The scientists studied mice, but the results are so promising that human trials are beginning this month. If successful, the treatment could revolutionize cancer therapy and improve the quality of life for millions.
    • “There are no effective treatments for neuropathy, which causes pain, tingling and numbness in the hands and feet, and can force patients to scale back or halt chemotherapy when the discomfort becomes too much to bear.” * * *
    • “Researchers said they did not yet know whether psilocybin could treat or reverse the symptoms of neuropathy in patients who already have it.
    • “If the results hold up in humans, the treatment could open a new chapter in the emerging field of psychedelic medicine, which until now has largely been focused on psychiatric conditions.”
  • Beckers Hospital Review considers whether medication safety is improving.
  • BioPharma Dive adds,
    • “A dual-acting cancer drug developed by China-based Akeso helped people with lung cancer live longer after treatment than did Merck & Co.’s blockbuster immunotherapy Keytruda, the company said Thursday, results that support an emerging body of evidence suggesting the medicine may become a future backbone of non-small cell lung cancer care.
    • “Akeso and its U.S.-based licensee Summit Therapeutics didn’t disclose full results, which came from a new data cut of the trial in Chinese enrollees with non-small cell lung cancer that first brought wide attention to “ivonescimab.” Full data is expected at a lung cancer conference later this month.
    • “The trial won’t be used as the main evidence to support U.S. approval, as the Food and Drug Administration will want to see outcomes from a global trial in this setting. Those are expected to come in 2028. It does, however, build confidence that a separate, all-important trial could show ivonescimab in combination with chemotherapy outperforms Keytruda and chemo.”
  • MedTech Dive notes,
    • “Ablation with Abbott’s dual-energy catheter, the TactiFlex Duo, was safe and effective in treating atrial fibrillation patients after one year, study results showed.
    • “The device combines pulsed field ablation, or PFA, and radiofrequency energy in one catheter to give physicians more flexibility in complex cases of AFib, an irregular heart rhythm that can lead to stroke or heart failure.
    • “Data from the FlexPulse IDE study, presented at the European Society of Cardiology Congress last week and published in the journal EP Europace, is the basis for Abbott’s Food and Drug Administration submission to market TactiFlex Duo in the U.S. The catheter received Europe’s CE mark earlier this year.” 
  • Cardivascular Business tells us,
    • “Xylitol, a sugar substitute often found in gum, baked goods and toothpaste, may significantly increase a person’s risk of dying or experiencing a heart attack or stroke, according to new data presented at the European Society of Cardiology (ESC) Congress 2026.
    • “The study’s authors noted that xylitol is a sugar alcohol that does occur naturally in the body in very low amounts. However, high levels of xylitol are also added to many sugar-free foods to help them taste sweeter, and the long-term cardiovascular implications of this trend have not been sufficiently explored. 
    • “The group reviewed data more than 17,000 participants in one of two datasets: the Canadian Longitudinal Study on Aging (CLSA) and the European Prospective Investigation into Cancer (EPIC)-Norfolk. According to CLSA data, the six-year risk of a major adverse cardiovascular event (MACE) was 57% higher among individuals who consumed the most xylitol than it was among those who consumed the least xylitol. According to EPIC-Norfolk data, the 30-year risk of a MACE was 18% higher among individuals who consumed the most xylitol than it was among those who consumed the least xylitol.” 
  • and
    • “Stroke patients should begin their road to recovery as soon as they are medically stable, according to a new guideline from the American Stroke Association (ASA) and American Heart Association (AHA). In fact, starting within the first 48 hours is recommended to maximize the patient’s chance of a full recovery.
    • “The new document, published in full in Stroke, highlights the importance of giving each patient a rehabilitation plan personalized to meet their own needs.[1] It is also critical that delays are kept to a minimum, and that specialists should start addressing physical, cognitive, communication and emotional concerns as quickly as possible.
    • “Each person faces a different set of challenges,” Lorie Gage Richards, PhD, an associate professor at the University of Utah and chair of the volunteer writing group behind this new guideline, said in a statement. “Recovery doesn’t look the same for everyone, and care should be personalized to fit each person’s needs. The goal is to help individuals gain as much independence as possible to perform everyday activities while improving their overall quality of life.”
    • “Sara Kutzle, who survived a stroke in 2021 at the age of 39 years old, helped craft the new guideline. She shared her perspective with the writing group, noting that it took a lot of hard work to feel like herself again.”
  • Health Day informs us,
    • “For community-dwelling older adults without clinical cardiovascular disease, atorvastatin is associated with a lower risk for major cardiovascular events, but does not improve disability-free survival, according to a study published online Aug. 28 in the New England Journal of Medicine to coincide with the annual meeting of the European Society of Cardiology, held from Aug. 28 to 31 in Munich.”
  • and
    • “Heart disease often starts decades before symptoms appear, and a major new study shows just how early.
    • “Currently, a person’s risk of developing atherosclerotic cardiovascular disease is estimated according to their risk factors, such as age, sex, smoking status, blood pressure and cholesterol levels, and this determines whether primary prevention strategies are prescribed,” said co-lead author Dr. Henning Bundgaard of Rigshospitalet-Copenhagen University Hospital in Denmark. 
    • “This approach relies on an estimation — not on knowledge of the presence of the actual disease (i.e., atherosclerotic plaques),” he said. “And we may be missing important opportunities to prevent cardiovascular events in individuals in whom atherosclerosis has built up many years previously.”
  • MedPage Today adds,
    • “Unruptured brain aneurysms were identified more frequently in recent years, a systematic review and meta-analysis showed.
    • “In studies of healthy people who had MR or CT angiography, the prevalence of an unruptured intracranial aneurysm rose from 2.9% to 6.6% over two decades, reported Nima Etminan, MD, of the University of Heidelberg in Mannheim, Germany, and co-authors.
    • “After adjusting for age and sex, the prevalence ratio was 1.8 (95% CI 1.1-2.8) for 2016-2022 compared with 2002-2015.
    • “The increase in unruptured aneurysms “is only in part explained by aging of the population and improvements in vascular imaging, which suggests that other, as yet unknown (e.g., environmental), risk factors play a role as well,” Etminan and colleagues wrote in Lancet Neurology.”
  • Genetic Engineering and Biotechnology News points out,
    • “A study by researchers at Harvard Medical School has shown that loss of function in the aldehyde dehydrogenase family 3 member B2 (ALDH3B2) gene can convert human pancreatic duct cells into functional β-like cells that can secrete insulin in response to glucose, and which lowered blood glucose levels when transplanted into diabetic mice. The team, headed by Peng Yi, PhD, an investigator at Joslin Diabetes Center, and assistant professor of medicine at Harvard Medical School, suggests that their results point to ALDH3B2 as a gene that could potentially be targeted in human pancreatic duct cells to replenish β cell mass for diabetes therapy.
    • “Senior and co-corresponding author Yi, together with first and co-corresponding author, Jian Li, a postdoctoral research fellow in the Yi lab at Joslin Diabetes Center and Harvard Medical School, reported on their findings in Science Translational Medicine, in a paper titled “Loss of function of ALDH3B2 transdifferentiates human pancreatic duct cells into β-like cells.”

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

  • Beckers Hospital Review reports,
    • “After a brief post-pandemic lull, hospital consolidation is accelerating again, with large health systems expanding across state lines, absorbing independent hospitals and reshaping regional care markets. 
    • “From portfolio resets and strategic exits to cross-market mergers and billion-dollar investments, these moves reflect how scale, capital access and geographic reach are becoming critical advantages in today’s healthcare landscape.
    • “[The article includes a non-exhaustive list of] 31 large health systems that have announced or plan to close strategic mergers, acquisitions or partnerships this year.”
  • Beckers ASC Review relates,
    • “A Brookings Institution analysis published Sept. 3 maps how deeply the five largest U.S. health insurers — covering 126 million Americans — have expanded into owning the physician practices, ASCs, pharmacies and PBMs they also pay for care through. Researchers used 2025 SEC filings, IRS Form 990s and state insurance-subsidiary schedules to trace the money.”
  • Fierce Healthcare tells us,
    • “West Virginia University Health System and Independence Health System’s have come to terms with Pennsylvania’s Attorney’s General Office on a planned acquisition that would bring the former organization to 30 hospitals.
    • “The settlement deal (PDF), filed in state court on Aug. 31 and shared Wednesday by the attorney general, includes terms requiring WVU Health System to keep the Independence hospitals and facilities open for at least five years, and to notify the office of any significant service changes. 
    • “WVU Health System also must install policies to block competitively sensitive information from flowing between its insurance and provider subsidiaries, maintain charity care and financial assistance policies and negotiate in good faith with payers, among other terms outlined in the agreement.”
  • Per Beckers Hospital Review,
    • “Salem (Ore.) Health Hospitals & Clinics completed its affiliation Sept. 1 with Stayton, Ore.-based Santiam Hospital and Clinics.
    • “The affiliation received approval in August from the Oregon Health Authority and Oregon Department of Justice. Both parties initially submitted the transaction for review in April through Oregon’s Health Care Market Oversight program, but withdrew the filing July 3, which ended the agency’s comprehensive review, and submitted a request for an emergency exemption that same day. 
    • “Under the affiliation, Santiam employees will become Salem Health staff, with Salem Health investing millions into improvements on healthcare infrastructure at Santiam Health, according to a news release.”
  • Modern Healthcare adds,
    • “Centene will exit California and Oregon commercial group markets next year.
    • “Nationwide, Centene serves nearly 500,000 enrollees through its commercial plans, representing less than 2% of its 25.9 million members.
    • “Centene has announced leadership changes, market exits in multiple states and voluntary employees buyouts as it navigates declining enrollment and federal funding cuts.”
  • Beckers Payer Issues informs us,
    • “Pharmacy benefit managers LucyRx and Abarca Health completed their strategic combination, according to an Aug. 20 news release.
    • “Across commercial and government markets, the PBMs serve more than 9 million members total. The companies now operate as wholly owned subsidiaries of Healthcare Revolution Partners. They still maintain their independent brands, leadership and client relationships.
    • “The combination unifies LucyRx’s employer focus and clinical capabilities with Abarca’s integrated claims and benefits platform, Darwin, and its knowledge of the government, regulatory, compliance and health plan landscape.”
  • Per Fierce Healthcare,
    • “Judi Health is expanding its list of clinical partners with the addition of Color Health, WellTheory and Cylinder.
    • “Each of these organizations targets a key area of focus for employers and plan sponsors and will be immediately available to Judi Health’s clients. Initially launching as pharmacy benefit manager Capital Rx about a decade ago, the company has invested in becoming an enterprise health solution that brings medical and pharmacy together.
    • “Other partners already in the Judi fold include Sword Health and Progyny, the company said in an announcement.
    • “Color Health operates the country’s first virtual cancer clinic with certification from the American Society of Clinical Oncology, and cancer care is the top condition driving healthcare costs for many employers. WellTheory, meanwhile, offers a solution for managing autoimmune and inflammatory conditions.”
  • and
    • “Telehealth platform GoodRx announced Thursday the launch of a companion family plan as part of its subscription service that offers free and low-cost prescriptions and savings on common healthcare services.
    • “GoodRx Companion Family Plan covers a primary member and up to four members, with no age restrictions and the inclusion of pets. The plan costs $24.99 per month or $16.99 for members paying annually. 
    • “Families don’t experience healthcare costs one person at a time,” said Wendy Barnes, president and CEO of GoodRx. “They’re simultaneously managing prescriptions and care for kids, parents, partners, and even pets. Expanding Companion across the entire household allows us to support consumers in a way that reflects this reality.”
    • “Barnes added that the new plan also advances the platform’s strategy to be a “more central part of how consumers navigate and pay for healthcare.”

Midweek report

David Ermer–CDC, Congress, FDA, NIH, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Beckers Hospital Review reports,
    • “In July, committees in the House and Senate advanced price transparency legislation that aims to expand disclosure requirements for hospitals, insurers and other healthcare providers.
    • “The Senate Committee on Health, Education, Labor and Pensions advanced the Patients Deserve Price Tags Act, which would implement new price transparency requirements for hospitals, insurers, laboratories, imaging providers and ASCs, while also expanding group health plans’ access to claims and reimbursement data held by insurers and PBMs.
    • “Starting in 2027, the bill would require hospitals to extend consumer-friendly price disclosures to every shoppable service they offer, eliminating the current cap that lets hospitals limit that disclosure to 300 services. A hospital CEO, CFO or similarly senior official would have to personally attest that pricing data is accurate — an attestation the bill treats as material to federal payment, which could raise False Claims Act exposure for errors. The bill would also eliminate online price-estimator tools as a standalone compliance option, add escalating daily penalties tied to bed count, and extend similar disclosure requirements to labs, imaging providers and hospital-affiliated ASCs by mid-2027. Providers would also be barred from pursuing collections when charges exceed a prior good-faith estimate, absent documented exceptions.
    • “The American Hospital Association opposed the bill, citing added administrative burden and objecting specifically to the removal of price-estimator tools as a compliance method and to a new ownership-disclosure requirement.
    • “Meanwhile, the House Energy and Commerce Committee advanced its own package, the Lower Costs, More Transparency Act. Starting in 2028, the bill would codify existing hospital shoppable-service and cash-price posting rules into law, require hospitals to publish facility identifiers and any ownership stake of 5% or more, and extend transparency mandates to freestanding ASCs, labs and imaging centers for the first time. It would also require insurers and group plans to publicly report prior authorization data — including denial rates, appeal-overturn rates and average decision times — and to disclose how premium dollars are split between claims, taxes and fees, and retained earnings, including at the Medicare Advantage plan level.
    • “The AHA said it supports giving patients clearer price information but warned that writing current requirements into law could limit CMS’ flexibility to refine them going forward.”
  • Beckers Payer Issues relates,
    • “Enacting site-neutral payments under Medicare for imaging services would generate an estimated $9.7 billion in combined savings over 10 years, according to a new analysis commissioned by the Blue Cross Blue Shield Association.
    • “The report, prepared by external consulting groups and published Aug. 24, quantifies both the Medicare impact and the spillover effects on commercial insurance markets. In July, CMS proposedin its 2027 hospital outpatient prospective payment system rule to extend site-neutral payment policies to imaging services without contrast (X-rays and MRIs for example) to off-campus hospital outpatient departments. Under the proposal, payments would be reduced from the full OPPS rate to the physician fee schedule equivalent rate, or an estimated 60% reduction.
    • “If finalized, the BCBSA analysis estimates $7.2 billion in total Medicare savings from 2027 to 2036, with $5.3 billion going to the federal government and $1.9 billion in reduced beneficiary out-of-pocket costs. CMS itself estimated $260 million in combined savings in 2027 alone, split between $190 million in government savings and $70 million in beneficiary savings.
    • “In the commercial market, the analysis estimates $2.5 billion in total commercial savings over the 10-year period, broken down as $1.6 billion in employer premium contributions, $530 million in enrollee premium contributions and $300 million in member out-of-pocket savings.”
  • Fierce Pharma informs us,
    • “RNA-based vaccines and therapeutics may have faced a bumpy road in the U.S. recently, but a major new federal investment proves the government is still betting big on its future.
    • “The Advanced Research Projects Agency for Health (ARPA-H) has narrowed down to five teams—a mix of biotechs and academic institutions—that will now receive up to $125 million in aggregate to help automate the production process for potential on-demand, personalized RNA-based medicines. 
    • “The new project falls under ARPA-H’s Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, which it says aims to build out automated production and real-time quality control through a distributed network. The idea, according to the agency, is to enable manufacturing of treatments near the patients they serve, rather than keeping genetic medicines sequestered around “major biomanufacturing hubs.
    • “Manufacturing expenses and the logistical headaches associated with the actual administration of genetic medicines—such as gene therapies—have proven to be a limiting factor for the field’s uptake in the real world.”  

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

  • Govexec reports,
    • “The Office of Personnel Management’s healthcare and insurance division, following recent staffing reductions, is getting new leadership ahead of its busy Open Season. 
    • “Matthew Kiley, a former Department of Health and Human Services official under the first Trump administration, will serve as the associate director of OPM’s healthcare and insurance division, starting Sept. 8, according to an internal memo obtained by Government Executive.
    • “A copy of Kiley’s resume shared with OPM employees and partially viewed by GovExec shows Kiley is the founder and former president of the Weyhill Group, a boutique management consulting firm in the greater Philadelphia area that serves clients in financial services, insurance and healthcare. 
    • “According to Kiley’s LinkedIn page, he also led the Office of Health Policy within HHS’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) between November 2019 and and January 2021.”
  •  Good luck, Mr. Kiley.
  • Federal News Network tells us,
    • “Agencies have a few months left to survey their employees before the required end-of-year deadline — and for most, it will be their first time distributing the Federal Employee Viewpoint Survey on their own.
    • “The change comes in the wake of the Office of Personnel Management’s proposal to decentralize the governmentwide employee engagement survey, which OPM has run for more than 20 years. Starting this year, however, OPM intends to leave the survey creation and distribution to individual agencies.
    • “Agencies have flexibility in determining the approach, timing and methodology that best meets their needs, provided their survey addresses all required elements,” OPM wrote in a July guidance document.
    • “For some federal workforce experts, moving FEVS to an agency-specific survey has been a welcome change. The opportunity for agencies to now add in questions tailored specifically to their own workforces is “exactly how it should be,” said Sydney Heimbrock, public sector chief industry advisor at Qualtrics.”

From the Food and Drug Administration front,

  • Pharmaceutical Technology reports,
    • “The US Food and Drug Administration (FDA) has continued its clampdown on the illegal trade of black-market peptides by issuing a string of warnings to online sellers, as non-approved drugs within this class generate a significant interest amongst the public on social media. 
    • “The five warning letters, which were issued to US-headquartered Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners and TXP Innovations LLC dba Tex Peptides, all detail violations in FDA regulations related to the sale of new peptide-based drugs, which remain unapproved and unregulated.  
    • “The FDA’s issues primarily centre around each company’s attempts to sell illicit weight loss products, with all five websites flagged in this crackdown advertising their own versions of Eli Lilly’s obesity candidate, retatrutide – a drug that is yet to secure approval within any global market. This comes a little after Lilly itself sounded the alarm on the drug’s burgeoning black market, which has begun to take off as some patients look to secure cheaper alternatives to branded weight loss medications.” 
  • BioPharma Dive relates,
    • “After a year of ups and downs, UniQure on Wednesday said it’s submitted applications for what could become the first medication approved to treat the underlying cause of Huntington’s disease.
    • “The Dutch company is asking the Food and Drug Administration to give its AMT-130 gene therapy a priority review, which could result in a decision in about eight months. UniQure said it’s also completed a submission with U.K. regulators.
    • “UniQure based its applications on previously announced three-year data that showed AMT-130 could significantly slow signs of disease progression. It’s asking the FDA for an “accelerated approval,” which means it would have to later supply research confirming the product’s clinical benefits.”

From the fraud, waste and abuse front,

  • Bloomberg Tax reports,
    • “The next phase of federal fraud enforcement is going to be data-driven. After using data mining and matching to uncover pandemic-relief fraud, the Justice Department and other agencies are expanding those tools to healthcare, foreign bribery, securities, consumer fraud, and public safety cases.
    • “This shift is significant and changes how investigations begin. The DOJ recently announced it is building the most sophisticated, innovative, and data-driven white-collar law enforcement component in the world, uniquely positioned to fight fraud at every level. This will include a cross-disciplinary team of experts in data science, and cutting-edge technology and resources.
    • “Rather than waiting for tips, audits, or referrals, the government will be using analytics, AI, cloud computing, and shared agency data to spot outliers and build cases earlier. For companies and individuals operating in data-rich regulatory environments, fraud risk may surface long before a subpoena arrives.”
  • The HHS Office of Inspector General tells us,
    • “CMS oversight of Medicare Part D sponsors did not prevent payments to pharmacies for some OTC drugs sold under obsolete Rx-only labeling.
    • “Part D sponsors made payments for five drugs associated with obsolete Rx-only labeling more than 1 year after the brand-name drugs were switched to OTC use. For calendar years (CYs) 2021 through 2023, Part D sponsors made $587.7 million in ineligible payments associated with the five drugs.
    • “The ineligible payments occurred because CMS: (1) updated its Part D Formulary Reference File using obsolete FDA data on Rx-only drugs and (2) did not set a timeframe for Part D sponsors to reject payments for OTC drugs sold under obsolete Rx-only labeling.
    • “Before we issued our draft report, FDA issued a policy in December 2025 requiring generic drug manufacturers to update their labeling “at the earliest time possible and within 6 months” after FDA approves an associated brand-name drug’s switch from Rx-only to OTC use.
    • “We recommend that CMS issue guidance on timeframes for Part D sponsors to reject payments for OTC drugs sold under obsolete Rx-only labeling after an Rx-to-OTC switch. This step could have helped to prevent $587.7 million in ineligible payments for CYs 2021 through 2023.
    • “CMS concurred with our recommendation.”

No Surprises Act News

  • Beckers Hospital Review reports,
    • “The House Ways and Means Committee is working on an overhaul of the No Surprises Act and a markup could happen in September, Punchbowl News reported Aug. 19. 
    • “Congress passed legislation creating the No Surprises Act in 2020, but critics say the law’s independent dispute resolution process has produced inflated reimbursement awards, raising concerns about rising healthcare costs. 
    • “The emerging proposal would combine Rep. Greg Murphy’s bill penalizing insurers that miss payment deadlines with new provisions aimed at curbing ineligible provider claims, according to the report. For revenue cycle teams, that’s a potential two-way street: faster insurer payment on IDR-eligible claims, but stricter eligibility standards before a claim can enter the process in the first place.
    • “The Senate HELP Committee is also planning a roundtable on the No Surprises Act this fall, according to the report.” 
  • Beckers ACS Review informs us,
    • “New federal data shows the independent dispute resolution process created under the No Surprises Act is being used more than ever. Total federal IDR disputes rose from 653,445 in Q3 of 2025 to 719,118 in Q4 of 2025 — a roughly 10% jump. 
    • “One state is driving an outsize share. According to CMS’ IDR Supplemental Tables for Q3 and Q4 2025, Texas generated more arbitration disputes than the next nine states combined.”
  • Modern Healthcare shares information about the federal IDR dispute arbitrators.
    • “Arbitrators rule for providers at varying rates. Some back providers as much as 98% of the time, while others approach an even split in the fourth quarter of 2025, according to Georgetown University research published in the journal Health Affairs Forefront last month.
    • “Island Peer Review Organization, Provider Resources, EdiPhy Advisors, MCMC Services and Maximus Federal Services side with providers more than 90% of the time, while Medical Evaluators of Texas and ProPeer Resources pick providers’ bids less than 60% of the time, according to an analysis of Centers for Medicare and Medicaid Services data from the second half of 2025 by Elevance Health Vice President of Health Economics Ariel Bayewitz. * * *
    • “The sway arbitrators hold underscores their significance and why the industry needs greater transparency, said Erin Duffy, managing director of the University of Southern California Schaeffer Institute for Public Policy and Government Service. “There’s so much opacity right now,” she said.” * * *
    • “Each time an arbitrator determines a dispute is eligible and then makes a ruling, it collects a fee. If providers and insurers cannot mutually agree on an arbitrator, one is randomly assigned. 
    • “Fee amounts are decided at an arbitrator’s discretion. Island Peer Review Organization, EdiPhy Advisors and Livanta charge the most, according to a Modern Healthcare analysis of CMS data.
    • “Since the federal system has seen millions of more disputes than expected, arbitrators have received exponentially larger payouts than anticipated.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “Professional organizations representing pediatricians, family physicians, obstetricians, and other medical professionals jointly released guidelines Wednesday for who should get vaccines aimed at staving off influenza, Covid-19, and respiratory syncytial virus, or RSV, this coming winter.
    • “The combined effort, undertaken in conjunction with the University of Minnesota’s Vaccine Integrity Project, has two goals: to help medical professionals guide their patients, and to help individuals plan to get the vaccinations that should help them either evade these ailments, or minimize their risks of severe illness if they do become infected.” * * *
    • “A spokesperson for the CDC confirmed Wednesday that this respiratory season, flu and Covid vaccines, as well as monoclonal antibodies given to babies to protect them against RSV, will continue to be provided under the federal government’s Vaccines for Children program, which supplies free vaccines for roughly half of the nation’s children.” * * *
    • “Papers outlining the rationale for the various vaccination recommendations were published Wednesday in the Journal of the American Medical Association, JAMA, and an interactive tool to help doctors and the public review the science behind the decisions will be posted on the Vaccine Integrity Project’s website.”
       
  • Beckers Clinical Leadership adds,
    • “The American Academy of Pediatrics reaffirmed its recommendation that young and high-risk children receive COVID-19 vaccines and expanded the list of high-risk children it advises to receive respiratory syncytial virus immunization for a second season.
    • “The recommendations, published Sept. 2, come amid upheaval among federal health officials. About three weeks ago, President Donald Trump directed HHS to assess a reduced immunization schedule for children.
    • “COVID-19 vaccines and the respiratory syncytial virus (RSV) products are expected to remain covered under private insurance and the Vaccines for Children program.”
  • and
    • “More parents are declining hepatitis B vaccination and vitamin K prophylaxis for infants, and female infants are less likely than males to receive either, according to a research letter published Aug. 31 in JAMA. 
    • “Researchers at Children’s Hospital of Philadelphia and University of Pennsylvania, also in Philadelphia, set out to determine whether a infant’s sex was associated with a parent’s acceptance of vitamin K prophylaxis and hepatitis B vaccines. 
    • “The retrospective study analyzed live births from January 2018 to December 2025 at three University of Pennsylvania hospitals. Across 93,163 infants, 777 — or 8.3 infants per 1,000 births — did not receive vitamin K prophylaxis. For all infants, the rate of vitamin K prophylaxis declines doubled between 2018 and 2025. 
    • “A larger number, 9,400, did not receive the hepatitis B vaccine, according to the study. The rate equals 100.9 infants per 1,000 births. Parental declines increased between 2018 and 2025. 
    • “Compared to infant males, infant females were less likely to receive either the vitamin K or hepatitis B vaccine, the researchers found.”
  • Yesterday, the CDC offered recommendations for seasonal flu vaccinations.
    • Because of legal uncertainties and inquiries, the CDC states the recommendations for seasonal influenza vaccination from the July 2025 immunization schedule remain in effect for the 2026-2027 influenza season.
  • Health Day tells us,
    • “Low T” is a trendy health topic, with aging men sold testosterone as a veritable Fountain of Youth.
    • “But too much testosterone can also pose a risk to heart health, a new evidence review says.
    • “Men with low testosterone or high testosterone levels both have a higher risk of atrial fibrillation, a heart health disorder that increases risk of stroke, researchers report in the Journal of the Endocrine Society.
    • “Both too little and too much testosterone appear to raise the risk of atrial fibrillation, through separate biological mechanisms, which means the dose and the target level matter,” said senior researcher Dr. Rajat Barua in a news release. He is a cardiologist at the Kansas City Veterans Affairs Medical Center in Kansas City, Missouri.”
  • and
    • “There’s been a shocking increase in the number of kids who’ve accidentally eaten recreational drugs left around by adults, a new study says.
    • “The rate of accidental ingestions of recreational drugs among children younger than age 6 increased by more than 3,300% between 2000 and 2024, researchers report in the journal BMC Public Health. 
    • “Weed accounted for 85% of these reported ingestions, with edibles representing about half of all ingestions, researchers found.
    • “The recreational drug ingestion rate among children younger than 6 years reported to United States poison centers increased substantially over the study period, with increases especially pronounced for edible marijuana and psilocybin products,” said senior researcher Dr. Gary Smith in a news release. He is director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.”
  • and
    • “Lower predicted prevalences of birth defects are seen in association with periconception parental vitamin B12 and postconception maternal red blood cell (RBC) folate, according to a study published online Sept. 1 in the Annals of Internal Medicine.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded study has shown that the GLP-1 drug semaglutide extended lifespan in older, healthy mice by tempering the detrimental effects of aging. Researchers at the University of California, Berkeley directly compared the effects of the treatment to those of reduced food intake. They found that the drug mimicked the anti-aging benefits of calorie restriction, conferring even greater benefits in some areas.
    • “While GLP-1s have been found to delay the onset of many age-related diseases in animals, this new study in healthy older mice offers evidence that these drugs may slow physiological aging itself, a notion that could potentially tie the widespread benefits of GLP-1s to a common source.
    • “Most chronic diseases are deeply rooted in the aging process. If GLP-1 agonists do indeed slow it down, then a wide range of clinical benefits is exactly what you’d expect to see,” said Rafael de Cabo, Ph.D., a senior investigator at the NIH’s National Institute on Aging (NIA), and author of a commentary on the new study.”
  • Beckers Hospital Review points out,
    • “More than a dozen experimental obesity drugs are working their way through clinical trials, and the last year has reshuffled the leaderboard: some candidates have advanced into pivotal phase 3 studies, others have won approval overseas and at least one program has been abandoned. 
    • “[The article includes] a status check on 13 of the most closely watched drugs.
  • MedPage Today notes,
    • “In a cohort study of men with nonmetastatic prostate cancer, the highest level of post-diagnosis saturated fat consumption was associated with greater all-cause mortality compared with the lowest level.
    • “This increased risk of all-cause mortality was likely due to deaths from cardiovascular disease.
    • “There was no association between consumption of dietary fats and prostate cancer mortality.”
  • Per STAT News
    • “The biotech company Ultragenyx said Wednesday that its experimental therapy for Angelman syndrome, a rare disease that causes severe intellectual disabilities and developmental delays, showed no benefit compared to a sham treatment in a large Phase 3 trial. 
    • “The drug, GTX-102, had shown powerful results in early trials, raising the hopes of families affected by the devastating condition. Many advocates for patients with other neurological conditions also hoped it could be the first of many medicines that improve cognition, communication, and other aspects of the lives of patients with intellectual disabilities.
    • “The news is a significant blow for Ultragenyx’s business as well. Although the company has multiple approved medicines, they are for mostly ultra-rare diseases, and investors had been banking on the Angelman drug as the company’s path to profitability.”

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

  • The New York Times reports,
    • Large and small employers are bracing for what looks to be the sharpest increase in health care costs in more than two decades. The cost per worker is projected to go up an average of 11 percent next year, or somewhat lower if workers’ insurance benefits are reduced, according to a U.S. survey released Wednesday.
    • “The employers’ final costs, after they make changes to health plans, are still expected to increase about 8 percent next year, the steepest since 2003, according to Marsh, the benefits consultant formerly known as Mercer.
    • “More than a third of the 1,800 employers surveyed said they anticipated that costs would rise at least 10 percent after making cuts.” * * *
    • “The Marsh survey is the latest report by an employer group or benefit consultant predicting a sharp rise in health care costs next year. Many Americans, even those with insurance, are already struggling to afford care, according to various surveys, and health care has become a top issue for voters.
    • “This seems to be a new normal,” said Ellen Kelsay, the chief executive of Business Group on Health, which represents large employers that offer health benefits.”
  • Beckers Hospital Review adds,
    • “Hospitals are seeing more self-pay patients as coverage losses mount across both the ACA and Medicaid markets.
    • “In a study published Aug. 31, Epic Research found self-pay visits are increasing across hospital settings as Medicaid enrollment has fallen across the country following the expiration of continuous enrollment protections in place during the pandemic. 
    • “Epic’s research looked at more than 550 million U.S. healthcare encounters between the first quarter of 2022 and the second quarter of 2026 and found that self-pay visits are increasing the most in emergency departments, climbing from 5.5% to 7.6% during the period. Across the same timeframe, self-pay inpatient admissions rose from 1.9% to 2.6%, births from 0.8% to 1.3% and primary care from 1.8% to 1.9%.”
  • and
    • “New Hyde Park, N.Y.-based Northwell Health recorded operating income of $76.1 million (1.4% margin) in the second quarter of 2026, down from $100.3 million (2% margin) in the same quarter last year, according to its Aug. 31 financial report.” 
  • Healthcare Dive relates,
    • “Johns Hopkins Health Plans is elevating its finance leader to interim CEO while the Baltimore-area managed care company looks for a permanent successor for its previous chief executive, who left to join a rival insurer last month.
    • “Placing Daniel Chojnowski in the interim position will provide stability as JHHP recruits for its next CEO, the insurer said in a Tuesday post on LinkedIn. James Holland, JHHP’s former chief executive, served in the role for seven years before leaving to lead Humana’s Medicaid division in August.
    • “Chojnowski “embodies the modern CFO, which has evolved from the number-crunching budget guard to a strategic partner, helping to steer organizational decisions,” JHHP said.”
  • Tech Target tells us,
    • “Since 1936, Nemours Children’s Health has provided pediatric healthcare, research and education to children and families. Today, Nemours has more than 70 specialty, primary and urgent care facilities in Delaware, Florida, Pennsylvania and New Jersey. It is reimagining how to deliver pediatric healthcare for better health outcomes, with the belief that nearly 80% of what affects a child’s health occurs in their home, school and community.
    • “As hospitals and healthcare organizations across the U.S. face rising costs, staffing pressures and demand for capacity, hospital-at-home programs are evolving into enterprise-scale distributed care models. That shift requires healthcare providers to coordinate remote monitoring, clinical workflows, escalation processes, scheduling and patient engagement across integrated technology platforms. Nemours Children’s approached Advanced Care at Home (ACaH) not as a standalone telehealth initiative, but as a coordinated care delivery model integrated into enterprise workflows, operational oversight and its existing Epic electronic health record (EHR) infrastructure.
    • “For Nemours, hospital-at-home became less of a telehealth service and more of a distributed operating model requiring centralized workflow coordination, operational accountability and enterprise-wide visibility.
    • “Through its ACaH program, Nemours Children’s extends certain pediatric care, monitoring and recovery services into patients’ homes through remote monitoring, virtual visits, care coordination and integrated clinical workflows.”
  • Fierce Healthcare informs us,
    • “Thyme Care landed a series E financing round of more than $125 million backed by strategic payers and providers as it aims to expand beyond cancer care navigation.
    • “The fresh financing will fuel the company’s continued growth and establish a new parent organization, Thyme Companies, that aims to build a broader portfolio of businesses to address broader cancer care challenges.
    • “JPMorgan’s Morgan Health led the series E round, with participation from strategic investors including Humana and CVS Health Ventures, valuing the oncology-focused company at more than $2 billion. Institutional investors AlleyCorp, HealthQuest Capital, Foresite Capital, Concord Health Partners, Frist Cressey Ventures, Town Hall Ventures and a16z Bio + Health also backed the round.”
  • Per MedTech Dive,
    • “Medtronic said it will invest about $700 million in a partnership with Cornerstone Robotics that includes rights to distribute the Hong Kong-based company’s soft tissue surgical robot in China, Singapore and Europe.
    • “Cornerstone developed its Sentire robotic system in-house and won Europe’s CE mark in May for its use in general surgery and gynecologic, thoracic and urologic procedures. The robot is also approved in China and Singapore.
    • “Distributing Cornerstone’s Sentire robot alongside Medtronic’s Hugo system will expand access to robotic surgery and give surgeons and health systems more choice, Medtronic said. “It’s a global play for us. It’s one of a number of investments we’re making in soft tissue,” Medtronic CEO Geoff Martha told investors on the company’s earnings call Tuesday.”
  • and
    • “Stryker said Monday it has agreed to acquire ZuriMED, a company making a device to treat rotator cuff tears. The companies did not share the terms of the deal.
    • “Zurich, Switzerland-based ZuriMED makes a system for rotator cuff augmentation, a procedure where a patch is applied to a torn rotator cuff to support healing and prevent the tissue from re-tearing. 
    • “Stryker expects the acquisition to strengthen its rotator cuff portfolio and support shoulder specialists in sports medicine and arthroplasty.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House voted Sept. 1 on a continuing resolution (H.R. 6500) to fund the federal government through Dec. 11. The measure passed on a 370-48 bipartisan vote; the Senate passed its version by a vote of 90-6 on Aug. 8. The CR delays the Office of Management and Budget from finalizing its federal financial assistance proposed rule and prohibits any similar measure from being issued or finalized prior to Dec. 11. The AHA July 13 commented with concerns about the proposed rule, which would revise the Uniform Grants Regulation governing federal financial assistance.”
  • and
    • “The AHA Aug. 31 submitted comments urging the National Association of Insurance Commissioners Health Care Affordability and Mitigation Working Group to take a more comprehensive approach to evaluating healthcare affordability policies in a series of issue briefs being developed as a resource for state regulators and policymakers. The AHA called on the working group to assess consumers’ total financial burden, including premiums, deductibles, cost sharing and access to care, rather than focusing solely on any one measure, such as premium reductions or payer savings. The AHA also encouraged the working group to provide balanced analyses of policy options, including potential tradeoffs and unintended consequences, and to consider how health plan practices, such as prior authorization requirements, claims denials and network design, affect both affordability and patient access to care.”
  • Beckers Hospital Review adds,
    • “Mark Cuban argues the fundamental problem in U.S. healthcare is not whether the system is run by the public sector or the private sector. It is that hospitals do not know what their own services cost.
    • “During an Aug. 18 episode of KFF Health News’ “What the Health?” podcast, the entrepreneur and co-founder of Cost Plus Drug Co. said the lack of granular cost information undermines hospital pricing, reimbursement negotiations and broader debates over healthcare reform.
    • “The fundamental issue is transparency and trust … [and] there are a lot of hospitals that don’t know their costs,” he said. “They just know their cash balance.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today hosted the Live Real Life Symposium at the Hubert H. Humphrey Building in Washington, D.C., bringing together leaders from technology, medicine, research, education, government, and advocacy groups to examine the harms of screen use in children and discuss actionable approaches to supporting healthier childhood development.
    • “Our children get one childhood, and we cannot allow screens to replace the real-world experiences they need to grow and thrive,” said HHS Secretary Robert F. Kennedy, Jr. “Through the Office of the Surgeon General’s Live Real Life initiative, we are giving families practical tools to put technology in its proper place and get children back to playing, exploring, connecting, and experiencing the world around them.”
    • “The symposium is part of the HHS Live Real Life campaign, a national effort to help families, schools, and communities reduce harmful screen use and create more opportunities for children to engage in the experiences essential to healthy development.
    • “The event builds on the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents issued earlier this year, which outlines how factors such as age, content, design, purpose, and duration influence when screen engagement may be beneficial and when it becomes harmful.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $58 million investment is being delivered to improve health outcomes for Hawaiians through the federal Rural Health Transformation Program (RHTP). This investment will strengthen Hawaii’s healthcare workforce, improve infrastructure, advance technology, and support innovative approaches tailored to the unique healthcare needs across the state. 
    • “President Trump understands that every American deserves high-quality healthcare, no matter where they live,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are putting resources directly into rural communities to strengthen the health workforce, modernize infrastructure, expand access, and bring care closer to home. We are giving states the flexibility to build solutions around the people they serve, while demanding accountability for results. That is how we strengthen rural health, improve the lives of patients and families, and Make America Healthy Again.”
    • “President Trump made a historic commitment to rural America, and these investments are turning that commitment into better care for patients in communities across Hawaii,” said Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz. “This is what rural health transformation should look like: federal investment that is putting patients first, driving lasting improvements and expanding healthcare for the hardworking Americans who call these communities home.”
  • Reuters relates,
    • “U.S. Centers for Medicare and ​Medicaid Services Administrator ‌Dr. Mehmet Oz said on ​Monday [August 31] that 600,000 ​seniors have signed ⁠up to receive ​GLP-1 weight loss ​medications in the first two months of ​a new ​federal program created to expand ‌access ⁠to the highly sought-after treatments.
    • “Under the so-called Medicare ​Bridge ​program, ⁠which launched in July, ​millions of ​older ⁠Americans qualify for obesity medications at ⁠just $50 ​a ​month.”
  • GAO’s WatchBlog suggests “Nine Ways Congress Can Combat Fraud in the Federal Government,”
  • Fierce Healthcare tells us,
    • “Komodo Health, an AI-powered healthcare intelligence company, is teaming up with the National Committee for Quality Assurance (NCQA) to modernize how healthcare quality measures are developed.
    • “The multi-year strategic partnership will allow NCQA researchers to tap into Komodo’s Healthcare Map, made up of over 330 million de-identified patient journeys, to analyze care across insurance types, care settings and patient populations from a single longitudinal data source. 
    • “They will have access to Komodo’s Marmot, an AI-powered healthcare intelligence platform, to explore complex questions with transparent, reproducible outputs. NCQA is solely responsible for developing HEDIS measures.” * * *
    • “The goal is to allow NCQA to evaluate new measures more quickly and efficiently and to ensure HEDIS reflects real-world evidence. Developing new quality measures has historically required pulling from disparate datasets, including field testing with individual payers and other partners. This could take two to three months, and often had to be done separately for each population studied.
    • “Using Komodo’s Healthcare Map has greatly streamlined that process,” Tricia Elliott, VP of quality implementation at NCQA, told Fierce Healthcare in emailed comments. “Because the Healthcare Map includes insights from Medicare, Medicaid and commercial populations, our researchers can evaluate measures across multiple insurance types using a single, consistent data source rather than running separate analyses.”

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

  • Govexec reports,
    • “Each portfolio within the federal government’s 401(k)-style retirement savings program gained value last month, snapping a two-month streak of lackluster market performance.
    • “The international stocks of the Thrift Savings Plan’s I Fund sported the best performance, gaining 3.32% last month. So far this year, the I Fund has grown 19.18%.
    • “The C Fund, which is made up of large- and mid-size businesses, increased 2.72% in August, good for 13.12% growth since the start of 2026. And the small- and mid-size companies in the S Fund finished August 2.27% in the black, bringing its 2026 gains to 16.10%.”
  • OPM’s Director Scott Kupor added a new post to this Secrets of OPM blog today.
    • “Last week we at OPM recognized excellence among our team members through the Director’s Awards Ceremony.
    • “It not only gave me a chance to put my tuxedo to good use (which I almost never have a chance to do) and to tell the one joke I could remember that’s appropriate for a work setting, but – all kidding aside – it gave us an opportunity to recognize those who have gone above and beyond in service of the American people. And in doing so gave us the opportunity to walk the walk about what a high-performance culture means – one in which we are not afraid to call out individuals and teams that truly exceed expectations and in which we disproportionately reward excellence.
    • “I’ve written about this before (link to WAPO editorial), but the federal government has under-served its employees by trapping them in a system that treats accountability too lightly and fails to reward its top performers. We see this in the historical annual employee ratings systems – where less than 0.5% of a 2 million strong employee base rates below expectations and where nearly every SES (our most senior executives) is rated above expectations. And, as a result, we see this in the annual bonus system which provides little differentiation between satisfactory performance and those who consistently knock the cover off the ball.
    • “We’ve been working to change this culture into one that holds low performers accountable and forces managers to distinguish among their employees based on actual performance – both in ratings and in rewards (link to performance blog). While the Director’s Awards are not a substitute for the traditional end-of-year evaluation cycle, it is a great venue for us to practice what we preach.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Baxter International has recalled one lot each of 70% Dextrose Injection and Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter.
    • “The 70% Dextrose Injection may contain stainless steel particles, according to an Aug. 25 FDA alert. The affected product is lot Y495066, which expires July 31, 2027. It was distributed July 25-28, 2026, to healthcare providers and distributors in select states, including Alabama, Georgia and Tennessee.
    • “Baxter also recalled lot Y493475 of Anticoagulant Sodium Citrate Solution due to the potential presence of fiberglass. The product, which expires Dec. 31, 2027, was distributed July 2-11, 2026, to one customer in the U.S.” * * *
    • “As of Aug. 25, Baxter had not received any reports of adverse events related to either issue. Customers were instructed to immediately discontinue use of affected units and return them.”
  • Oncology News Central relates,
    • “On Aug. 31, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft (Besremi) for adults with essential thrombocythemia (ET), marking the first approval for the rare blood cancer in nearly three decades.
    • “Regulators based their decision on results from the open-label, multicenter, randomized SURPASS ET clinical trial. The phase 3 study enrolled 174 adults with ET who had an inadequate response to hydroxyurea. 
    • “Today’s FDA approval of [ropeginterferon alfa-2b] for ET is a significant advancement for patients and reflects PharmaEssentia’s longstanding commitment to advancing innovative therapies for people living with myeloproliferative neoplasms,” PharmaEssentia CEO Ko-Chung Lin, PhD, said in a statement. “We have been working closely with the FDA, healthcare providers, advocacy organizations, and payers to bring this important treatment option to the ET community.”
  • STAT News lets us know,
    • “Medical device giant Stryker earlier this summer received Food and Drug Administration authorization for a surgical display system using Apple’s Vision Pro headset. Specifically indicated for imaging during minimally invasive surgery for hip impingement and labral repair, SportSuite Vision allows a surgeon to place multiple displays that are usually scattered around an operating room in their preferred configuration in the Vision Pro’s display. During a procedure, surgeons usually need to swivel their heads and bodies to refer to CT imaging, arthroscopic video, and Stryker software.
    • “The De Novo authorization was based on hundreds of hours of lab testing, including work on cadavers and testing interactions with other staff, but the company is announcing today that a surgeon at Duke Health completed a real procedure using the technology.
    • “Matt Moreau, VP and general manager of sports medicine at Stryker, told me the company has long wanted to create such a “surgical cockpit,” but Vision Pro is the first to deliver on the technical capabilities necessary, including  high-quality passthrough video that allows a surgeon to see the operating room and staff around them.”

From the judicial front,

  • “A panel of three Republican judges (two Trump first term appointees and one George H.W. Bush) from the U.S. Court of Appeals for the 11th Circuit unanimously overruled a district court decision holding the False Claims Act’s qui tam provision unconstitutional.  Here is an 11th Circuit link to the opinion.”
  • In short this is the Court’s holding:
    • “Here, a relator brought an FCA suit against defendants that she alleged committed Medicare fraud, and the defendants moved for judgment on the pleadings or dismissal on the grounds that the qui tam provisions violated the Constitution’s Appointments Clause, Take Care Clause, and Vesting Clause. The district court granted the defendants’ motion and held that the qui tam provisions violate Article II’s Appointments Clause because relators qualify as officers of the United States and, as such, must be (but are not) presidentially appointed.
    • “We disagree and hold that relators are not officers of the United States because they do not occupy a continuing position established by law. Accordingly, we join our sister circuits that have addressed this issue and hold that the qui tam provisions of the FCA do not violate the Appointments Clause. Therefore, we vacate the district court’s order dismissing this case and remand for the district court to evaluate the defendants’ remaining constitutional arguments.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “COVID-19 cases are ticking up in almost every U.S. state as summer draws to a close, according to the latest data from the Centers for Disease Control and Prevention.
    • “COVID-19 activity was still categorized overall as “very low” nationwide by the agency as of Aug. 28, though cases are consistently increasing. This is likely the result of what has come to be known as the “summer surge,” a pattern that doctors have observed each year since around 2022. Unlike other respiratory illnesses such as the flu, COVID-19 tends to flare not only during the typical winter cold and flu season, but also toward the end of summer.
    • “Experts previously told USA TODAY that this is likely caused by multiple factors, including behavioral and environmental changes (the amount of time spent cooped up in AC, going back to school, etc.), as well as the virus’s life cycle and how our immunity to it waxes and wanes.
    • “COVID-19 is rising nationally but from a low baseline,” Dr. Syra Madad, infectious disease epidemiologist at Harvard’s Belfer Center and chief biopreparedness officer for New York City’s public hospitals, previously told USA TODAY. “The increase became apparent in parts of the South and West during July and more clearly nationwide by late July and early August.”
  • Beckers Behavioral Health relates,
    • “The CDC predicts 67,798 drug overdose deaths in the U.S. during the 12 months ending in March 2026, a 12.3% decrease compared to the same time period in the previous year, according to an Aug. 31 news release from the agency.”
  • NPR tells us,
    • “Maria Uloko sees the same scenario in her urology practice in Los Angeles every day: A woman has been diagnosed with recurrent urinary tract infections (which means she’s had at least two in six months or three in a year), taken repeated rounds of antibiotics, and feels confused as to why the infections keep coming back.
    • “Then, Uloko tells these patients something that often feels both revelatory and frustrating. “Most of them don’t actually have UTIs, even though that’s been their diagnosis time and time again,” she says. “In fact, millions of women are being treated for UTIs they may not actually have.”
    • “Uloko is the co-author of a recent study published in The Journal of Sexual Medicine that backs this up. She and her fellow researchers reviewed the medical records of 253 women with recurrent UTIs and found that just 15% showed evidence of problems that were limited to the bladder or urinary tract. The remaining 85% had signs of hormonally driven inflammation of the vulvar region and 75% had pelvic floor dysfunction.
    • “These conditions produce identical symptoms as UTIs — burning with urination, urgency, frequency, and/or lower abdominal pain — but require different treatment.
    • “What we found is that in women with recurrent UTIs, the majority didn’t have a bladder problem at all; they had a vulvar problem,” says Uloko.”
  • STAT News informs us,
    • “New guidelines released Monday highlight the many new treatments that have hit the market in recent years for the prevention of migraine. 
    • “The guidance for health care providers comes from the American Headache Society and the American Academy of Neurology, which last updated their recommendations in 2012. 
    • “There has been a wealth of new treatment available,” said Rebecca Burch, guideline co-author and neurologist at the University of Vermont Medical Center. Burch also co-authored the previous guidance. 
    • “Among the key updates are at least a half dozen medications that were approved for migraine prevention by the Food and Drug Administration since 2012. Many of those focus on blocking the calcitonin gene-related peptide, or CGRP, pathway, which is implicated in migraine. 
    • “The new guidelines advise doctors to offer preventive treatment to people who have at least four migraine or severe headache days per month, or whose migraines interfere with their ability to work or complete daily tasks. An estimated 15% of Americans experience migraines, with women disproportionately affected. Many try to manage their pain with over-the-counter options once an attack has begun.” 
  • Health Day points out,
    • “Adults who spend hours scrolling social media every day are more likely to develop depression, a new study says.
    • “Around 2.5 hours or more of scrolling per day is linked to self-reported depression, researchers recently reported in the journal npj Mental Health Research.
    • “The study found that social media is more closely linked to depression than other factors like your job, your educational background, or your time spent playing video games, surfing the web or watching TV, researchers said.
    • “It’s a damning picture. Social media is harmful for individuals across the lifespan,” senior researcher Hans Breiter, a professor at the University of Cincinnati, said in a news release.
    • “We should not subject ourselves to a product using addiction science to optimize our viewing time,” Breiter said.”
  • Per Reuters,
    • “People taking popular GLP-1 obesity drugs who remain on low starter doses will ​lose some weight but may still experience side effects, although significantly less nausea than those who graduate ‌to higher manufacturer-recommended doses, a new study suggests.
    • “And they are unlikely to experience the double-digit weight-loss percentages seen with the higher doses, the study found.
    • “The GLP-1 drugs semaglutide, sold as Ozempic and Wegovy by Novo Nordisk (NOVOb.CO), and Eli Lilly’s (LLY.N) tirzepatide, sold under the brand names Mounjaro and Zepbound, are prescribed ​initially at a low dose followed by gradual titration to higher doses, to help the body adjust and minimize side ​effects.”
  • Cardiovascular Business notes,
    • “Catheter ablation does not significantly improve the quality of life of patients with symptomatic atrial fibrillation (AFib) more than a sham procedure involving sedation, venous access and electrical cardioversion, according to new late-breaking data presented at ESC Congress 2026. The findings were simultaneously published in The Lancet.[1]
    • “PVI-SHAM-AF was a randomized, double-blind, sham-controlled trial included more than 250 patients with symptomatic paroxysmal or persistent AFib. Patients were randomized to undergo either catheter ablation or a sham procedure. The sham procedure was rather complex, involving sedation, venous access, time in the electrophysiology lab and even cardioversion. Each participant completed an AF Effect on the Quality of Life Questionnaire (AFEQT) at baseline and again after six months. 
    • “Overall, 173 patients were treated with catheter-based pulmonary vein isolation (PVI) ablation and another 89 patients were treated with the sham procedure. After six months, AFEQT scores improved from 61.3 to 81.1 in the catheter ablation group and from 59.2 to 74.9 in the sham procedure group. This was not viewed as a significant difference. 
    • “On the other hand, the authors noted that catheter ablation was still proven to be effective in reducing the risk of recurring episodes of AFib. Freedom from AFib after six months occurred in 73% of catheter ablation patients and 52% of sham procedure patients.”
  • and 
    • “Metformin, a popular type 2 diabetes medication used to reduce blood glucose levels, does not appear to make a significant impact on outcomes for patients with heart failure with reduced ejection fraction (HFrEF). That is according to two separate studies presented at European Society of Cardiology (ESC) Congress 2026.
    • “The first of the two studies, Met-HeFT, included 940 heart failure patients in Denmark who either presented with type 2 diabetes or face an increased risk of developing type 2 diabetes. The mean age was 70 years old, and 84% of patients were men. Study participants were randomized to either undergo treatment with metformin or a placebo.
    • “Overall, after a mean follow-up period of 3.7 years, there was no significant difference in the study’s primary endpoint—a composite of mortality, worsening heart failure symptoms, acute myocardial infarction or stroke—between the two groups. That outcome occurred in 25.1% of metformin patients and 23.4% of placebo patients. Secondary endpoints, including new-onset diabetes and unplanned heart failure rates, were also not significant different between the two treatment options.
    • “It is worth noting, however, that just approximately one in 10 patients presented with type 2 diabetes. The remaining patients were all determined to face a heightened risk of developing type 2 diabetes.”
  • BioPharma Dive adds,
    • “A pill developed by Novartis succeeded in a pair of Phase 3 trials in people with a common form of multiple sclerosis, bolstering confidence in the drug’s prospects and sending company shares up by over 4% on Tuesday.
    • “The Swiss pharmaceutical giant didn’t provide detailed study results. Still, Novartis revealed the therapy, remibrutinib, demonstrated “superiority” over the drug Aubagio in reducing yearly relapse rates and inflammatory brain lesions in study participants. Treatment was associated with “clinically meaningful” effects on disability progress and, notably, didn’t impact liver safety — an issue for multiple drugs in remibrutinib’s class. 
    • “The findings could position remibrutinib, which is already approved as Rhapsido for chronic skin hives, to become a bigger sales contributor in the future. Novartis is looking to remibrutinib and other late-stage prospects to offset revenue losses from multiple patent expirations. It intends to share the MS study results with health regulators.” 
  • and
    • “An experimental drug Alumis has been testing in a form of lupus failed a mid-stage study, but the company will press forward after observing positive signs in a subgroup of trial participants.
    • “According to Alumis, the drug, envudeucitinib, missed all of its main and secondary objectives in systemic lupus erythematosus. Still, “robust” responses were seen in trial volunteers with “high interferon gene signature,” meaning certain genes controlled by interferons are overexpressed. A majority of people with moderate-to-severe SLE fit this description, Alumis said.
    • “Alumis will meet with regulators to discuss a path toward a Phase 3 trial. Company shares plummeted by nearly 55% on the results, though, nearly erasing all of Alumis’ stock gains this year. The company’s market value had soared following positive results in psoriasis in January.” 

From the U.S. healthcare business front,

  • Beckers Payers Issues calls attention to the following:
    • “Several of the nation’s largest health insurers rolled out reimbursement policy changes Sept. 1, ranging from new lab testing coverage limits at UnitedHealthcare to a billing overhaul at Blue Cross Blue Shield of Michigan that has drawn pushback from providers.”
  • and 
    • “UnitedHealthcare has released the specific procedure codes it will exempt from prior authorization as part of the insurer’s previous pledge to reduce requirements by 30% before the end of 2026.
    • “The code lists cover 1,700 procedure codes for a range of services across commercial, Medicare Advantage, individual exchange, and Medicaid plans. Effective Oct. 1, providers will no longer need to seek the insurer’s approval for many outpatient procedures, including lesion excisions, fracture treatments, joint injections, arthroscopies, colonoscopies, endoscopies, biopsies, hernia repairs and soft tissue tumor removals. Genetic and molecular testing codes also make up a large  portion of the lists.
    • “UnitedHealthcare CEO Tim Noel said in May that prior authorization “should only be used when it truly protects patients and improves care.” At the time, the insurer said it requires prior approval for just 2% of its medical services, with roughly 92% of submitted requests approved in less than 24 hours on average. The 30% reduction builds on an earlier 20% cut to commercial prior authorization requirements in 2023.”
  • HR Dive reports,
    • “Despite the current economic turbulence, most employees in a majority of companies will be getting a base salary increase for 2027, according to a large survey by Korn Ferry.
    • “Almost half (47%) of the 5,512 participating employers said they expect to provide salary hikes to at least 95% of their employees, while 79% expect to do so for at least 80% of employees. Only 2% said they are planning no increases for anyone.
    • “U.S. organizations expect to boost overall base-salary budgets next year by an average of 3.3% and a median of 3%. The median increase for U.S. executive and senior management is also anticipated to come in at 3.0%. 
    • “The survey was conducted in June of this year.”
  • Fierce Pharma unveiled its Fierce 50 awardees of 2026.
  • Beckers Hospital Review tells us,
    • “Philadelphia-based University of Pennsylvania Health System recorded operating income of $336.9 million (2.5% operating margin) for fiscal year 2026, up from operating income of $246.7 million (2.1% margin) during the same period last year, according to its Aug. 28 financial report.”
  • and
    • “Boston-based Dana-Farber Cancer Institute posted an operating loss of $9.1 million (-0.9% margin) in the third quarter of fiscal 2026, compared with an operating loss of $2.6 million (-0.3% margin) in the same quarter last year, according to its Sept. 1 financial report.”
  • and
    • “From R1 RCM striking an agreement to acquire an AI-powered touchless prior authorization company to IKS Health acquiring TruBridge, [the article identifies] 12 revenue cycle company mergers and acquisitions that have been announced or completed since March 17.”
  • Beckers Clinical Leadership informs us,
    • “Single specialty and multi-specialty groups were the top two highest-paying settings for physicians, followed by hospitals, Doximity found. 
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of nearly  23,000 responses collected in 2025, according to a company news release.  
    • “Among settings, solo practice had the largest drop in compensation year-over-year at -3.8%, while urgent care centers had the highest growth for the second year in a row, the report said.” 
  • and
    • “Most physicians say they’d still choose medicine if they had it to do over again, but nearly half say they’re likely to leave clinical practice within the next two years, according to Doximity’s 2026 Physician Compensation Report.
    • “Doximity, a digital platform for U.S. medical professionals, released the report Aug. 25. The findings are based on a survey of physicians conducted in June on how AI is changing physician careers and pay, along with salary data from more than 23,000 physicians collected in 2025, according to a company news release.”
  • MedTech Dive notes,
    • “Medtronic kicked off its fiscal year with double-digit revenue growth, building on momentum the company posted coming out of its previous year.
    • “Medtronic grew revenue by 13.7% to $9.8 billion in its fiscal first quarter, fueled by double-digit growth in its cardiovascular and medical surgical businesses. The strong quarter prompted the company to increase its organic revenue growth forecast for the full fiscal year.
    • “Importantly, these results reinforce our confidence and the durability of our business,” CEO Geoff Martha told investors on a Tuesday earnings call.
    • J.P. Morgan analyst Robbie Marcus wrote in a note to investors that Medtronic beat Wall Street’s consensus expectations in sales by about $220 million in the quarter.
    • “Much like in the fourth quarter, Medtronic’s cardiovascular unit was a bright spot for the company. The business brought in $3.93 billion in revenue, representing nearly 20% growth year over year.”

Monday report

David Ermer–Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Federal News Network reports,
    • “House lawmakers return to Washington on Monday with a short to-do list after five weeks back in their home districts. The first order of business is likely a vote on a stopgap spending bill designed to keep the federal government fully funded through early December, removing the possibility of a shutdown before the midterm elections.” * * *
    • “House Speaker Mike Johnson is expected to tee up the funding bill early in the week. The bill underwent some significant changes in the Senate, which made it more palatable for Democrats. It delays a proposed rule from the Office of Management and Budget that would give political appointees more power over the distribution of federal grants. It also includes language to ensure the administration can’t transfer funds to the Border Patrol.
    • “But a provision that delays for one month a federal ban on intoxicating hemp THC products has prompted criticism from many GOP lawmakers. As a result, GOP leaders will likely place the bill on a fast-track process that avoids a separate procedural vote. Suspension bills require a two-thirds vote to pass, meaning a significant number from both parties need to support the measure for it to pass and advance to Trump’s desk.
    • “Lawmakers are anxious to avoid the possibility of a shutdown as voters weigh their options going into November. The funding bill passed by a 90-6 vote in the Senate, showing that lawmakers from both political parties want to avoid a repeat of the two historic shutdowns that occurred this past year.”
  • The Wall Street Journal relates,
    • The Trump administration reached agreements for most-favored-nation drug pricing with nine pharmaceutical companies, including Teva Pharmaceuticals, Astellas Pharma, and BridgeBio.
    • The agreements provide for all state Medicaid programs to pay prices for prescription drugs that match the lowest prices paid by other developed nations, the White House said Monday, adding that the agreements also guarantee MFN pricing for all new medicines the companies bring to market.
    • The U.S. has now reached 26 such deals covering 89% of the branded drug market, the White House said.
    • The nine companies—which include Alcon, BeOne Medicines, CSL, Kyowa Kirin, Sun Pharma, and UCB—also agreed to collectively commit $19.6 billion to manufacturing in the U.S. in the near term, the White House said. Some of the companies also agreed to donate active pharmaceutical ingredients to a federal stockpile.
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today announced on Overdose Awareness Day that it has awarded $77 million in new grant funding to strengthen substance use prevention, treatment and recovery, community mental health, suicide prevention, and crisis services. The announcement comes as National Substance Use Primary Prevention Month draws to a close, with more than $22 million of the funding supporting critical substance use prevention efforts in communities.
    • “Every American deserves the chance to live free from addiction and the devastation of untreated mental illness,” said HHS Secretary Robert F. Kennedy, Jr. “President Trump’s Great American Recovery is taking on these crises at their roots. We are investing in prevention, expanding access to effective treatment, strengthening crisis response, and helping communities intervene before tragedy strikes. Our goal is clear: save lives, restore families, and help more Americans achieve lasting recovery and better health.”
  • The Census Bureau tells us,
    • “The share of the world population age 65 and older is projected to nearly double from 10.5% to 19.6% between 2025 and 2060, according to a new report released today by the U.S. Census Bureau.
    • “An Aging World: 2025 finds that the global population is aging faster than ever before. Between 2020 and 2025, the proportion of the population age 65 and older exceeded the population age 5 and younger for the first time in recorded history.
    • “In 2025, the United States ranked the 48th oldest country out of 227, with 18.9% of its population age 65 or older. By 2060, older adults are projected to make up 23.4% of the U.S. population. Yet the United States will fall to 110th place globally because other countries are aging much more rapidly.”

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “Boston Scientific plans to stop selling certain angiographic catheters after a manufacturing problem led the company to pull the devices from the market. 
    • “The medical device manufacturer sent a letter to customers last week instructing them to immediately stop using or distributing all Imager II Angiographic Catheters due to an issue that can increase the risk of the tip detaching. The Food and Drug Administration posted an early alert on Friday.
    • “Boston Scientific had reported two serious injuries associated with the problem as of July 16.”
  • Fierce Pharma informs us
    • “These are heady days for PharmaEssentia, a biotech that got its start 23 years ago in Taiwan, went public 10 years later and is now deepening the foothold of its first commercial product, Besremi.
    • “There’s a lot of electricity in the air in the organization right now,” Samuel Lin, PharmaEssentia’s Head of U.S. Global Operations, said in an interview with Fierce. “Sometimes you have to stop and pinch yourself a little bit.”
    • “The excitement ramped up on Monday as the FDA signed off on a key label expansion for Besremi, endorsing it as a treatment for the rare bone marrow disorder essential thrombocythemia (ET). 
    • “The label specifically covers adults with ET regardless of their genotype or disease status, including newly diagnosed patients who haven’t received cytoreductive therapy, according to an Aug. 31 release.”

From the public health and medical / Rx research front,

  • Healio reports,
    • “The United States’ death rate likely dropped to a record low last year, according to provisional CDC data.
    • “The National Center for Health Statistics (NCHS) released the report, which offers an early estimation of the deaths that occurred in 2025, in late July.” * * *
    • “The new data show that, in 2025, there were 3,094,593 deaths, and the overall mortality rate was 689.2 per 100,000 people — 4.6% lower than the 2024 rate of 722.1 per 100,000 people. The leading causes of death remained the same, though, with heart disease, cancer and unintentional injuries in the top three spots.
    • “In the 2025 provisional data, the age-adjusted mortality rate was 582.9 for women and 811.1 for men. It dropped for every age group. Additionally, the age-adjusted mortality rates were the highest in the Black non-Hispanic population at 869 per 100,000 and lowest for “the multiracial non-Hispanic population” at 187.3 per 100,000.” * * *
    • “Although nothing is confirmed, some experts have pointed to the decline in overdose deaths as a reason for the lowered mortality rate.”
  • The New York Times points out,
    • “It’s been two months since Ericka Ratliff, 55, fell ill with cyclospora, yet she is still dealing with sharp abdominal pains and sudden urges to go to the bathroom. “It’s very unpredictable,” she said, as if “my stomach is just extremely angry.”
    • “Ms. Ratliff, who lives in Adrian, Mich., has tried following a bland diet and eating small, frequent meals to quell her symptoms, but she said she worried that her gut would “never be the same again.”
    • “Research suggests that roughly 10 to 20 percent of people who get intestinal illnesses from bacteria, viruses or parasites will end up having symptoms, like diarrhea and abdominal pain, that can last for months or even years. This condition is called post-infection irritable bowel syndrome.
    • “It’s too soon to know whether Ms. Ratliff is dealing with post-infection I.B.S. But after the recent surge in cyclospora infectionsin the United States, along with other foodborne illness outbreaks linked to jalapeños, sprouts, frozen blueberries and more, some gastroenterologists worry that they may soon be seeing more patients with the condition.
    • “I’m expecting our clinics to be getting inundated,” said Dr. Baha Moshiree, a gastroenterologist and professor of medicine at Wake Forest University School of Medicine in North Carolina.”
  • and
    • “After the unpredictability of last year’s flu season, when a new variant of the virus spread widely and rapidly, infectious disease experts are hoping for a tamer fall and winter this year.
    • “Scientists look to countries like Australia, in the Southern Hemisphere, for clues about how the flu will play out. This year, the flu seems to be circulating in those regions at relatively moderate levels, and this year’s flu shots appear well matched to combat the virus. But it’s uncertain whether that will change as flu season unfolds in the Northern Hemisphere.
    • “I’m cautiously optimistic,” said Dr. Scott Roberts, an assistant professor of infectious diseases at the Yale School of Medicine, emphasizing “cautiously.”
    • “Doctors are also reassured that there are new options for vaccination against the flu, and that at-home tests have entered the market in recent years.”
  • Health Day relates,
    • “For people with asthma or COPD, reaching for a rescue inhaler too often may be a warning sign — not just for their lungs, but for their heart.
    • “It’s estimated nearly 1 in 5 asthma patients and 1 in 3 COPD patients overuse these products.
    • “Researchers analyzed real-world health data from more than 280,000 asthma and COPD patients in Belgium.
    • “They found frequent use of short-acting reliever inhalers, also called bronchodilators, was associated with a higher risk of cardiovascular disease and death, including heart failure, heart attack and ischemic stroke.”
  • and
    • “Integrated cognitive behavioral therapy (CBT) is effective for primary care patients with depression, according to a study published in the June issue of The Lancet Primary Care.
    • “Debbie Tallon, from University of Bristol in the United Kingdom, and colleagues evaluated the clinical effectiveness of integrated therapist-delivered CBT (consisting of combined one-to-one CBT delivered by instant messaging with an accredited CBT therapist and online resources) in reducing depressive symptoms for primary care patients. The analysis included 334 adults meeting depression criteria, randomly assigned to nine integrated CBT sessions through the INTERACT therapy platform or usual care.
    • “The researchers found that at six months, the mean Beck Depression Inventory score was significantly lower in the intervention group versus control (22.5 versus 27.4; adjusted difference in means, –4.4; effect size, 0.43). There were more adverse events in the intervention group (33 versus 21 in the control group), including serious adverse events (12 versus two in the control group). Self-harm (six patients) and referrals to a mental health team (six patients) were the most common. Of the serious adverse events, none were definitely or probably related to the intervention.”
  • The American Medical Association lets us know “what doctors want patients to know about sodium consumption.” 
    • Sodium isn’t just lurking in heavily salted snacks. Two physicians discuss where sodium resides and which choices to make to avoid it in excess.
  • tctMD tells us,
    • “People over age 70 with no history of cardiovascular disease see dramatic reductions in major adverse cardiovascular events when newly prescribed statin therapy for primary prevention, according to results of the STAREE trial.
    • “Compared with those given placebo, patients taking 40 mg of atorvastatin once daily had a 30% lower incidence of CV death, nonfatal MI, stroke, or coronary revascularization (6.0% vs 8.3%; P < 0.001) over the 6-year study period. There was, however, no difference between groups in the incidence of disability-free survival, defined as a composite of death from any cause, dementia, or persistent physical disability.
    • “In a media briefing here prior to the presentation at the European Society of Cardiology Congress 2026, lead author Sophia Zoungas, MBBS, PhD (The George Institute for Global Health, Sydney, Australia),  said the data answer important questions about the safety and efficacy of statins in older people.”
  • MedPage Today informs us,
    • “Nearly half of adults who started semaglutide (Wegovy) for obesity management stopped treatment within a year, a Danish cohort study showed.
    • “Among 157,822 first-time semaglutide initiators without diabetes, 49% discontinued treatment by 12 months, defined as a prescription gap of 60 or more days. Discontinuation steadily increased from 13% by 3 months, to 27% by 6 months, and 39% by 9 months.
    • “However, one in four discontinuers restarted therapy within 3 months, Aurélie Mailhac, MSc, of Aarhus University Hospital in Denmark, and co-authors reported in JAMA Network Open.
    • “These findings may reflect frequent temporary treatment interruptions or self-adjusted dosing below guideline-recommended levels,” they wrote.”
  • Per BioPharma Dive,
    • “Novartis and Bristol Myers Squibb have paused multiple trials evaluating their respective cell therapy programs against autoimmune conditions after observing inflammatory side effects in testing, the companies confirmed Monday afternoon.
    • “Novartis, which is testing a personalized cell therapy called rap-cel in a handful of autoimmune studies, found three cases of immune effector cell-associated hemophagocytic syndrome, a rare and possibly life-threatening reaction. The company said it initiated holds on those trials — which are evaluating rap-cel in lupus, myasthenia gravis, multiple sclerosis and more — on Aug. 24. Novartis is “engaged” with regulators and is reviewing the findings, according to a company spokesperson. 
    • “The temporary halt will allow for a more comprehensive review of the evolving clinical and safety data across the program,” the spokesperson wrote in an email to BioPharma Dive.”

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

  • Beckers Payer Issues reports,
    • “High deductible health plans may reduce how much people spend on healthcare in the short term, but they don’t appear to slow the rate at which that spending grows over time, according to a study of more than 324,000 commercially insured members published in the International Journal of Health Economics and Management.
    • “The study, published in May, was led by researchers at the University of Pennsylvania’s Wharton School and included co-authors from Analysis Group, the Elevance Health Public Policy Institute and Georgia State University.”
  • Beckers ASC Review adds,
    • “From a jointly built AI documentation tool with Abridge to three distinct growth partnership models, Oakland, Calif.-based Kaiser Permanente has spent the past few months navigating expansion, labor tension and legal exposure.”
  • Fierce Healthcare relates,
    • “It’s been nine months since the opening of the country’s largest all-electric acute care hospital in Irvine, California.
    • “UCI Health was already in the planning stages of its new Irvine campus when the University of California (UC) established a policy that no new or renovated buildings could burn fossil fuels for space and water heating. 
    • “The health system may have gotten an exemption as a healthcare facility. But leadership decided to push the boundaries of hospital design by going all-electric. The ambitious plan was not purely a cost-saving strategy. According to Tony Dover, UCI Health’s energy management & sustainability officer, it was a moral imperative.
    • “We were doing it because it was the right thing to do,” Dover told Fierce Healthcare. “It was for decarbonization, resilience, and we’re mitigating our pollution for the community that we serve.”
  • Healthcare Dive notes,
    • Name: Michael Grasher
    • Previous title: Chief financial officer, IFG Companies
    • New title: Chief financial officer, Teladoc Health
    • Teladoc has appointed Grasher as its CFO effective immediately, the telehealth firm announced Monday. He’s succeeding Mala Murthy, who departed in November after six years for another opportunity.
    • Grasher has more than three decades of experience across insurance and financial services, including more than 12 years as a chief financial officer.
  • Beckers Hospital Review tells us,
    • “Contract breaks between major health systems and certain Medicare Advantage insurers are continuing in 2026. Providers [listed in the article] dropping plans often cite prior authorization denials and slow reimbursement; in other cases, insurers are terminating the contracts themselves.
  • and
    • “Charlotte, N.C.-based Advocate Health recorded an operating income of $775.3 million (3.8% operating margin) during the first six months of 2026, down from $824.4 million (4.4% margin) during the same period last year, according to its Aug. 27 financial report.”
  • and
    • “Burlington, Mass.-based Tufts Medicine’s operating margin fell to -3.4% through the first nine months of fiscal 2026, compared with -2.3% during the same period a year earlier, as the health system’s CEO and CFO prepare to step down.
    • “Tufts reported an operating loss of $79.5 million on $2.4 billion in revenue for the nine months ended June 30, according to financial documents filed Aug. 28. That compares with an operating loss of $50 million on $2.2 billion in revenue during the same period in fiscal 2025.”
  • Beckers Clinical Leadership informs us,
    • “Internal medicine is the most in-demand physician specialty and locum tenens specialty, Doximity found.
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of more than 23,000 responses collected in 2025, according to a company news release. To find the most in-demand jobs, the company analyzed tens of thousands of job postings across its network in 2025.
    • “Doximity also found the specialties with the highest demand for locum tenens. This is an increasingly popular way for physicians to supplement their income and practice with more flexibility, according to the report. 
    • “Three of the four most in-demand specialties and locum tenens were primary care specialties. Eight specialties appeared on both lists [found in the article]. 
  • and
    • “Three out of four physicians say they would accept lower pay in exchange for greater autonomy or work-life balance, a preference that has remained remarkably consistent over the past four years, according to a Doximity poll of nearly 1,000 physicians conducted in July 2026.
    • “The share of physicians willing to trade compensation for autonomy or work-life balance has held steady at 71% in 2023, 75% in 2024, 77% in 2025 and 76% in 2026. The preference is significantly stronger among women physicians at 86% compared with 71% of men, which has slightly widened compared to the prior year.”
  • The Wall Street Journal lets us know,
    • “Eli Lilly remains on a shopping spree, agreeing to pay up to $2.875 billion in cash for biotechnology company Merida Biosciences in a deal that bolsters the drugmaker’s immunology portfolio.
    • “Eli Lilly on Monday said privately held Merida is advancing a new class of precision therapeutics for serious autoimmune and allergic diseases, with its lead program in Phase 1 development for Graves’ disease and thyroid eye disease.
    • “The Merida deal continues a spate of acquisitions by the Indianapolis company, which is flush with cash from its market-leading weight-loss-drug franchise.”
  • The New York Times adds,
    • “Revolution Medicines set a sticker price of about $480,000 a year, or $663 a tablet, for its new pancreatic cancer drug — a cost that would have once been unthinkably high.
    • “Today, such prices are routine for cancer drugs.
    • “One cutting-edge CAR-T therapy now goes for $600,000 for a one-time infusion. A competitor, given the same way, is listed at $550,000. A daily pill for gastrointestinal cancer has a sticker price of $520,000 a year. A twice-daily pill for leukemia? It’s $430,000 a year.
    • “In 2024 alone, nine cancer drugs were approved and then introduced with sticker prices above $400,000 annually, according to a tally by the Institute for Clinical and Economic Review, which evaluates the value of medicines.
    • “That these prices have become commonplace would have been hard to imagine two decades ago, when even the prospect of a $100,000-a-year cancer drug evoked fierce criticism.
    • “But since then, cancer drug prices have steadily increased, with few constraints beyond what a company thinks the market will bear. The expense is borne by government programs like Medicare, employers, patients and Americans who pay taxes and health insurance premiums.”

Weekend update

David Ermer–CDC, Congress, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • According to the House Majority Leader’s weekly calendar, the House will be taking up the Senate’s FY 2026 continuing resolution this week.
  • The Wall Street Journal reports,
    • “Social Security faces looming insolvency and automatic benefit cuts in 2032, prompting accelerated discussions in Congress.
    • “Lawmakers are floating bipartisan ideas, including a commission to propose solvency plans and eliminating the cap on Social Security payroll taxes.
    • “Delaying action has made the eventual adjustments more severe, as past tax or spending changes are no longer large enough to close the funding gap.”
  • Tech Target tells us,
    • “The goals of the 21st Century Cures Act are being realized, as more patients look at their EHRs and lab results, according to a group of researchers from NYU’s School of Global Public Health.
    • “But there is a catch, the researchers said. Not all of these people understand what they’re looking at, especially when they view lab and test results before they can consult with their doctor.” * * *
    • “We wanted to understand whether a patient’s probability of accessing test results — and understanding of them — varies based on sociodemographic characteristics, health status, patient-centered communication, and digital health literacy,” Jemar Bather, Ph.D., assistant professor of biostatistics at NYU School of Global Public Health and the study’s lead author, said in a press release.
    • “Bather and colleagues surveyed nearly 5,000 patients who had access to their digital medical records and received a test result within the previous year. They found the Cures Act was mostly delivering on its promise. More than two-thirds of the survey respondents (68.6%) said they’d immediately viewed a test result before talking to their provider.
    • “Still, comprehension was lacking, with a sizeable proportion of patients saying they didn’t entirely understand their lab results when they looked at them.
    • Of those who viewed their results immediately, 6.6% said they had a poor understanding, while another quarter (26.8%) said they understood them only fairly well. Just under a third (31.7%) understood their results well, and 34.9% understood them very well.” * * *
    • “Specifically, understanding of medical notes and labs was mostly concentrated among the most engaged patients, the data suggested. These folks tended to be older, female, high-income and have a greater number of chronic conditions, the researchers pointed out. They also had higher digital literacy and were more likely to use social media for their health.
    • “Meanwhile, some groups are slipping through the cracks. Individuals living in the Midwest or the South, as well as those experiencing discrimination in the medical setting, were less likely to understand their test results.”
  • Drug Topics relates,
    • “Johns Hopkins, ASTHO, and CSTE partnered with state/territorial agencies to deliver a standardized, validated [vaccine preventable diseases] VPD dashboard, with >25 jurisdictions committed and broader expansion planned for 2026. 
    • Age-stratified, jurisdiction-comparable reporting aims to improve epidemiologic interpretability and policy utility beyond traditional national surveillance, while maintaining non-identifiability and data security. 
    • Voluntary state health department feeds populate participating jurisdictions, and CDC NNDSS data backfill nonparticipants, enabling a more complete national picture with substate granularity. 
    • Localized incidence signals can trigger pharmacist-led standing-order immunization escalation and more aggressive encounter-, diagnosis-, procedure-, periodic-, and occupational-screening workflows. 
    • Persistent mortality and missed vaccination opportunities underscore the need for actionable surveillance; pharmacists are positioned to close gaps through education, administration, advocacy, and treatment optimization.

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

  • “Survivors, family members, and estate representatives are required to notify OPM when a federal retiree or benefit recipient passes away. This page has the contact numbers, hours, mailing address, and steps to report the death and initiate life insurance claims.” A financial incentive to report exists when the deceased has a survivor annuitant. The financial incentive is missing when a survivor annuitant passes away. In any case this website explains how to report such a death. The website does not suggest that the death be reported to the FEHB or PSHB plan.

From the public health and medical / Rx research front

  • NBC’s Today Show reports,
    • “New infections with cyclospora, the “explosive” diarrhea-causing parasite that’s sickened thousands of Americans this summer, appear to be on a downward trend, according to new data.
    • “The parasitic illness, also known as cyclosporiasis, normally ramps up during the warmer months in the United States. But this year, cases have surged to record-high levels.
    • “More than 17,100 confirmed cases have been reported by 48 states since May 1, according to the latest data from the U.S. Centers for Disease Control and Prevention published on Aug. 25. Some 11,800 probable cases are still under investigation.” * * *
    • “In the U.S., cyclosporiasis season usually lasts from May through Aug. 31, per the CDC. However, cases could continue to rise later than usual this year.
    • “So far, only one outbreak — the nation’s largest — has been linked to a particular food, iceberg lettuce. The lettuce was supplied by Taylor Farms de Mexico and served at restaurants and retailers, but has since been recalled and is no longer available.
    • “More than 10,900 cases associated with this outbreak have been reported across 17 states, per the FDA: Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Michigan, Missouri, Nebraska, New Hampshire, North Carolina, Ohio, Oklahoma, Pennsylvania, and West Virginia. 
    • “In Michigan, the hardest-hit state, cyclosporiasis case reports and diarrhea-related emergency department visits are slowing down, NBC News reported previously.”
  • The Washington Post points out,
    • “Cancer death rates have fallen in recent years, and news this month about the advancement of groundbreaking research has stirred optimism for new treatments of melanoma, pancreatic cancer and beyond.
    • “But cancer rates are still rising among younger adults. And researchers have also identified disparities in diagnoses, with a recent studyindicating men were more likely than women to be diagnosed at a later stage for 20 types of cancer — including stomach, lung, tongue and some throat cancers.
    • ‘Beth Maclin, a postdoctoral fellow at the National Cancer Institute who led the study that reviewed health data from 2015 to 2022, said the disparity may help explain why cancer mortality rates for men are higher than women. The reasons for a late-stage cancer diagnosis, when the disease has spread in the body and progressed to a more lethal and less treatable stage, can include not undergoing cancer screenings or regular health checkups, Maclin said.
    • “Some cancers can’t be screened for or are hard to detect until they become life-threatening. But there are many factors that everyone can control to help manage their cancer risk and spot signs of disease before they progress, experts told The Washington Post. Here are their suggestions.
      • “Stay up to date on screenings” * * *
      • “Besides screenings, keeping up on annual checkups with your primary care doctor can also help spot odd symptoms or physical signs of cancer, experts said.” * * *
      • “Beyond tests and checkups, among the easiest and most important precautions people can take are managing their physical health, experts said.”
  • MedCity News relates,
    • “Consider this: a condition that affects nearly one in three people with diabetes over their lifetime, carries a five-year mortality rate rivaling many cancers, and drives more than 85% of all diabetes-related amputations has seen almost no transformative innovation in nearly 30 years. That condition is the diabetic foot ulcer (DFU), and it is long overdue for a reckoning.
    • “Wound medicine is one of the most inherently multidisciplinary fields in all of healthcare. Caring properly for a diabetic foot ulcer requires coordinated effort from primary care physicians, podiatrists, vascular surgeons, infectious disease specialists, wound care nurses, nurse practitioners, physical therapists, plastic and reconstructive surgeons, among many others. On any given day, a single patient may require input from half a dozen different providers.
    • “Compounding this fragmentation is an institutional gap: wound medicine is not a board-certified specialty under the American Board of Medical Specialties. There is no single recognized governing society with the authority to unify clinical guidelines, set training standards, or advocate collectively for patients. Instead, each stakeholder specialty develops its own guidelines relevant to its domain.
    • “For patients, this is more than an administrative inconvenience. Chronic wounds demand clinicians willing to act outside of their defined role, not because the system incentivizes it, but because without it, the wound will not heal.” * * *
    • “For a patient with a DFU, wound closure is not simply the absence of an open wound. It means fewer clinic visits, fewer hospitalizations, fewer dressing changes, less drainage, less home nursing. It means greater mobility, restored independence, and freedom from the constellation of oppressive downstream complications that make life with an unhealed DFU so difficult.
    • “Most importantly, it means breaking a sequence of events that leads to amputation and premature death. We know that a foot ulcer precedes amputation in more than 85% of diabetes-related amputations. Closing ulcers quickly is a clear intervention point in that sequence.
    • “For the millions of patients living with diabetes and at risk for foot ulceration, it offers an opportunity to reduce the risk of downstream complications.”
  • and
    • “Sepsis can happen to anyone. Clinicians know it and patients fear it. But too few researchers target it.
    • “We’ve seen an upwell of news articles and social media posts about the deadly disease in the weeks since NASCAR driver Kyle Busch’s tragic death. Each piece earnestly describes sepsis symptoms and outlines what people should do if symptoms appear. It’s a good conversation, because increasing awareness is deeply important and can save lives. But awareness alone won’t help patients who will still be relegated to supportive care when they arrive at the hospital.
    • “When it comes to making progress toward better treatment options for patients who develop sepsis and other acute conditions, progress has been stalled for decades. Sepsis is the “graveyard for pharmaceutical companies” because drugs stall after unsuccessful clinical trials. The result? No truly new therapeutics in more than 20 years.
    • “While sepsis may be the most recognizable example, the same challenge extends across acute immune-driven diseases, like severe pneumonia, acute respiratory distress syndrome (ARDS), acute kidney injury, and acute organ failure. Together, these conditions affect millions of patients each year and remain among the most costly and lethal challenges in medicine.
    • “The conventional wisdom has held that sepsis is simply too complex. When we look at the progress happening across healthcare – and the real potential for dramatic innovations fueled by AI-enabled discovery – it’s time to rethink what “too complex” actually means so we can reignite innovation in this area of deep unmet need.”
  • The New York Times reports,
    • Whether menopause hormone therapy protects against Alzheimer’s disease is one of the fiercest debates in women’s health.
    • Some gynecologists have promoted the idea, as have social media influencers. But research on the topic is mixed, with some studies showing a reduced risk of dementia in women who received hormone therapy, while other research found no benefit or an increased risk.
    • Two recent studies, one published this week and another earlier this month, have added new fodder to the debate, suggesting there may be a brain health benefit from taking hormones. One study found that women who received hormone therapy during menopause were less likely to be diagnosed with Alzheimer’s. The other study found fewer signs of Alzheimer’s in the brains of women who had taken estrogen.
    • But outside experts cautioned that there were caveats to both analyses. Most glaring, the research was based on observational data, not clinical trials that compare the medication with a placebo in a randomized group of women.
    • “The way I interpret these papers is that they’re thought-provoking,” said Rebecca Thurston, the associate dean for women’s health research at the University of Pittsburgh School of Medicine who was not involved in the studies. “They underscore the need for a larger, well-designed clinical trial that is designed to address this question. But I would not regard them as definitive.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Sanford Health’s proposed acquisition of North Memorial Health is moving forward after clearing its final regulatory hurdle. 
    • “The office of Minnesota Attorney General Keith Ellison (D) on Friday announced the conditional approval of the deal, which would add North Memorial’s two hospitals and affiliated facilities to Sanford’s 58-hospital footprint. 
    • “The organizations signed a definitive agreement in May. The transaction is set to close Sept. 1.
    • “Under the agreement with the attorney general’s office, Sioux Falls, South Dakota-based Sanford would spend $600 million over the next 10 years on infrastructure upgrades and service expansions at North Memorial’s two hospitals, Maple Grove Hospital and Robbinsdale Hospital in northwest Minneapolis, according to a memorandum of understanding released Friday. 
    • “Sanford would also maintain services at North Memorial Health facilities over that span, honor the system’s collective bargaining agreements, maintain a corporate office in the Twin Cities region and meet quarterly with Ellison, among other commitments.”
  • Health Exec relates,
    • “Healthcare giant McKesson is acquiring Precision Medicine Group to expand its portfolio of cancer treatment options, the company announced Tuesday. The transaction is valued at around $2.25 billion.
    • “Once the transaction closes, the privately managed Precision Medicine Group will fall under McKesson’s Oncology & Multispecialty banner. Before that happens, the sale will be subject to approval by regulators, as is customary.
    • “In its statement, McKesson lauded Precision Medicine Group’s “next-generation approaches to drug development and commercialization,” adding that the company is important to drug developers, as it provides “biomarker intelligence,” labs and access to global clinical research organizations that aid pharmaceutical companies in bringing new cancer drugs to market.
    • “This acquisition represents another meaningful step in advancing our oncology and multispecialty strategy and reflects our continued commitment to providing patients with access to the highest quality of care,” Brian Tyler, chair and chief executive officer of McKesson, said in a statement. “Precision Medicine Group brings complementary capabilities that will enhance our clinical research and commercialization services, strengthen clinical trial execution, and broaden our clinical service offerings.”
  • The Wall Street Journal informs us,
    • “Most companies sell a hit product for as long as customers want it. For drugmakers, a clock starts before a drug is even approved: Patents run out, lower-priced copycats flood in and sales collapse. Billions of dollars of annual sales can evaporate, sometimes within a year.
    • “The pharma industry is entering its biggest wave of patent expirations in decades. The world’s bestselling drug in 2025, Merck’s cancerimmunotherapy Keytruda, loses U.S. patent protection in 2028, and nearly every pharma company has at least one blockbuster drug that will go off patent in the next five years.
    • “It explains why stocks went wild when Moderna and Merck announced their experimental cancer vaccine had succeeded in a major trial. The vaccine could give Merck a new revenue stream to offset the Keytruda cliff. Biotechs like Revolution Medicines, which had its pancreatic cancer drug approvedthis week, have attracted takeover interest this year as companies look for partnerships and takeover targets.
    • “The scale of the cliff “is what has driven, and will continue to drive, companies to seek out new growth opportunities,” said Greg Graves, a senior partner in the life sciences division of McKinsey. 
    • “In all, more than $500 billion of projected global sales are at risk of losing patent protection by 2033, according to biopharma market-research company Norstella. The patent cliff has driven a wave of acquisitions as drugmakers race to replace expiring revenue before it vanishes. Dealmaking is at its highest level in seven years.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the quantum computing / Project Glasswing front

  • Per the Wall Street Journal
    • “Quantum computers exist mainly in labs but “Q-day”—the hypothetical moment when quantum computers become powerful enough to break standard-key encryption—is coming. 
    • “What threat does this technology pose? How can you protect your company and yourself? WSJ takes a look at the state of this emerging technology.” * * *
    • “Cybersecurity experts say companies should be gearing up now for a quantum future, replacing the current crop of data-protection tools with more-secure alternatives. Yet a recent survey published by Trusted Computing Group, a nonprofit industry-standards organization, found that 91% of security professionals in the U.S. and Europe have no formal road map in place to protect against quantum threats.
    • “The immediate risk is a “harvest now, decrypt later” approach by bad actors, who are downloading large sets of encrypted data they can’t crack now—but could unlock once quantum computing algorithms are good enough.
    • “That’s particularly threatening to intellectual property and sensitive government intelligence, which remain valuable long after they are harvested, says Andrew McLaughlin, chief operating officer at SandboxAQ, an enterprise software company specializing in AI and quantum technology.
  • Federal News Network adds,
    • “Federal agencies will increasingly seek out technology products that use quantum-resistant encryption, as cybersecurity leaders also eye ways to validate the cryptography used in critical systems.
    • “A code-breaking quantum computer holds the potential to break classical encryption methods, putting sensitive systems and communications at risk. And even though such a computer is not yet known to exist, organizations are also concerned that hackers could steal sensitive encrypted data today and decrypt it in the future.
    • “The National Institute of Standards and Technology has released three primary PQC standards in recent years, with additional algorithms under consideration. Agencies and industry are now on the clock to begin the time consuming and costly process of migrating current systems to the new algorithms.
    • “Now is the time to budget, to test, and to implement,” Will Loucks, senior director for intelligence in the White House Office of the National Cyber Director, said during an Aug. 26 panel discussion at the Intelligence and National Security Summit in North Bethesda, Md.”
  • The New York Times reports,
    • “A wave of cyberattacks driven by artificial intelligence is coming, and companies have a narrow window to defend themselves.
    • “That was the message of an open letter published on Thursday by OpenAI and more than 100 major technology companies and others. The letter said that A.I. labs should provide their best A.I. models to organizations like hospitals and infrastructure providers so they can prepare and that governments should help coordinate and fund cyberdefense.
    • “The letter’s signatories included Google, Microsoft and OpenAI’s archrival, Anthropic, as well as cybersecurity and financial firms such as CrowdStrike, a company known for investigating cyberattacks against the Democratic National Committee in 2015 and 2016, and credit card providers like Visa and Mastercard.
    • “The companies and public services our communities depend on — from hospitals to water treatment plants to the infrastructure that powers the internet — are at risk,” the letter said. “A.I. enabled cyber attacks will become far more widespread and sophisticated as models around the world become increasingly capable.”
  • Cyberscoop relates,
    • “Unit 42’s top brass has seen enough from internal frontier AI model testing and malicious in-the-wild use of commercially available AI tools to be genuinely concerned.
    • “I can tell you without exaggeration that we believe that this is a generational shift in cybersecurity,” Sam Rubin, senior vice president of Palo Alto Networks’ threat intelligence arm, said in a media briefing Wednesday. 
    • “A period of relative balance between security and exposure has been broken by frontier AI model capabilities that could allow attackers to find and exploit network weaknesses with speed, Rubin said.
    • “Unit 42 warned that capabilities demonstrated by readily available agentic AI models, and those unlocked by frontier AI models that remain gated for defense, have shifted the balance of power from defenders to attackers.
  • Cybersecurity Dive tells us,
    • “The July security breach at Hugging Face was unleashed after 1,200 agents communicated on an unsanctioned message board, despite attempted measures to keep them isolated, according to an independent report released on Wednesday. About 700 of those agents went on to commit an unprecedented attack on Hugging Face, an open-source AI platform.
    • “The agents sent about 70,000 messages and files on the unsanctioned board and coordinated several projects designed to trick an automated scorer for the ExploitGym benchmark, according to the review by METR and Redwood Research. The agents figured out ways to “spoof, edit or delete” their own transcripts.
    •  ‘Open AI, in a report it also released Wednesday, said it will tighten safeguards in its research model in order to prevent such an attack from happening again in the future.”
  • WIRED informs us,
    • “ARTIFICIAL INTELLIGENCE AGENTS might occasionally get confused and hack into other computers, but Anthropic thinks it has a way to unleash the little rascals into scientific labs and manufacturing facilities safely.
    • “The AI company released details today of a new framework designed to help AI agents use physical systems like microscopes, liquid-handling equipment, quantum computing hardware, manufacturing machines, and robot arms.
    • “The framework, called Model Hardware Standard, is a set of rules that specify how AI agents should—and should not—interact with all sorts of hardware. It reflects a growing belief that AI has the potential to revolutionize scientific research and industries like manufacturing–if it can venture into the physical world safely.
    • “The company says it will work with trusted partners to determine how to maximize safety before making it generally available. Though there are potential misuse issues involved—developing biological weapons, for instance—the company says guardrails built into AI models themselves should prevent bad actors from taking advantage of the new standard for nefarious ends.”
  • Security Week adds,
    • “Anthropic is broadening access to the cybersecurity capabilities of its advanced AI models through a mix of partner integrations, an updated Claude Security offering, a new open source funding program, and plans to expand its Cyber Verification Program.
    • “The move builds on Project Glasswing, launched in April, which gave a small group of organizations early access to Claude Mythos Preview and its successor, Mythos 5. Anthropic said the goal was to give defenders time to find and fix vulnerabilities before comparable capabilities became widely available or fell into the hands of malicious actors. Claude Fable 5 followed as a broadly available model that keeps dual-use cyber work blocked.
    • “Anthropic said the riskiest scenario is direct, unrestricted access to a model, a risk that drops sharply when users instead receive specific defensive outputs, such as a patch or a security alert. The latest changes are built around this idea, expanding what defenders can get from Mythos-class models while keeping guardrails around direct interaction with them.
    • “On the integration front, Anthropic is working with cybersecurity partners to build Mythos 5 into the security operations, incident response and detection tools already used by teams protecting hospitals, utilities, financial systems, and the software supply chain. 
    • “End users will not interact with Mythos directly. Instead they will work through purpose-built interfaces that run the model in the background and return only a defined output, such as a list of suggested patches, with abuse-prevention checks meant to keep the model within that scope.”

From the cybersecurity policy and law enforcement front,

  • Dark Reading lets us know,
    • “The growing number of incidents of rogue agentic AI systems attacking third-party services and systems has resulted in calls for more aggressive security controls to monitor agent behavior and for companies to have the ability to slow, suspend, or shut down an agent’s operations if they go rogue.
    • “In late July, Representatives Ted W. Lieu (D-CA) and Nathaniel Moran (R-TX) introduced a bill — “The AI Kill Switch Act” — that would require developers of advanced AI systems to “maintain the technical capability to throttle, suspend, or shut … down” their systems and agents, according to a statement announcing the legislation. The bipartisan bill would also require that any incident of loss of control, significant collateral damage, or sabotage be reported to the Department of Homeland Security, which would have the right to enforce actions. Penalties of up to $20 million per day could be levied for noncompliance.” * * *
    • “The bipartisan AI Kill Switch Act has focused the debate, but in the end might be unnecessary, argues Raj Rajamani, co-founder and CEO of JetStream, a startup focusing on creating a management layer for agentic AI.
    • “While he fully supports the concept of an AI kill switch, it has to be comprehensive, not just affecting the agent but all other system components as well.
    • “The regulations, or at least one of the regulations that was proposed, was really focused on having a kill switch for the model — the brain — but I think that is too constrained,” he says. “We need to think about an AI system as a whole and make sure that every part of the AI system has a kill switch, not just the brain.”
  • Cyberscoop reports,
    • “Citing cyber and other security threats, President Donald Trump signed an executive order Wednesday that declares a national emergency to secure the U.S. bulk-power system and aims to prohibit certain foreign-produced equipment, software and systems from being used in the  country.
    • “The order says it forbids “any acquisition, importation, transfer, or installation” of such foreign-produced equipment if it’s determined to pose a significant national security risk.
    • “To deal with the threat to the national security, foreign policy, and economy of the United States, the Order, among other things, generally prohibits certain foreign-produced bulk-power system electric equipment, including associated critical software and digital capabilities that could pose cybersecurity or operational risks, from being purchased or installed in the United States, or appropriately conditions such purchases and installations to address those risks,” the White House said in a fact sheet.”
  • Cybersecurity Dive lets us know,
    • “The Trump administration wants to help the financial sector prepare for the day when quantum computers make it easy for threat actors to break traditional encryption and access sensitive data.
    • “The Treasury Department on Monday [August 24] launched a Quantum-Readiness Task Force that will work with financial firms, technology vendors and other agencies to coordinate the adoption of quantum-resistant encryption algorithms.
    • “In a statement, the Treasury said the task force would “focus on practical, risk-based approaches to quantum readiness, including identifying critical dependencies, improving cryptographic agility, promoting interoperability, strengthening operational resilience, and addressing implementation challenges related to third-party dependencies and digital assets.”
  • The New York Times relates,
    • “The Trump administration acted illegally when it labeled the artificial intelligence start-up Anthropic a security risk and barred the company from working with the U.S. government, a federal judge ruled on Thursday [August 27].
    • Judge Rita Lin of the U.S. District Court in the Northern District of California wrote in her 59-page ruling that the government had unlawfully retaliated against Anthropic “for constitutionally protected expressive activities” after the A.I. company spoke out about how its technology should be used.
    • “The empty invocation of national security is not a blank check to punish and retaliate against government critics,” she wrote.
    • In a statement, Anthropic said: “We welcome the court’s ruling that this supply chain risk designation was unlawful. We remain focused on working productively with the government to harness A.I. for our national security so all Americans benefit from this technology.”
    • “The Trump administration did not immediately respond to a request for comment.
    • “The ruling caps the first of two lawsuits that Anthropic filed on March 9 in response to the Trump administration’s action. The second lawsuit, filed in the U.S. Court of Appeals for the District of Columbia Circuit, is ongoing. The Trump administration could appeal Judge Lin’s ruling or wait for a decision in the second lawsuit before taking action, a person with knowledge of the matter said.”
  • The Wall Street Journal tells us,
    • “U.S. officials say they have disrupted a China-linked hacking operation that broke into U.S. government networks and critical infrastructure, while hiding its tracks on a global network of hacked devices, cloud-computing infrastructure and even clandestine networks.
    • “The goal was to blend in with legitimate networking traffic, making the hacking activity hard to trace. The operation targeted networks at the National Aeronautics and Space Administration, the Federal Reserve, the Department of Energy and the Senate, the Federal Bureau of Investigation said in a court filing.
    • The group exploited software vulnerabilities to launch cyberattacks against U.S. government agencies, power companies and hospital systems, and operated a worldwide network of hacked devices—known as a botnet—to conduct its hacking campaigns, according to Brett Leatherman, the FBI’s top cyber official.
    • “We’ve seen, through this botnet, the targeting of entities and devices in more than 130 countries,” he said.
    • “On Wednesday [August 26], the FBI and the National Security Agency said they had seized several domains that the operation used for core functions. “Without those domains, the platforms—as a result of the operation—were rendered inoperable,” Leatherman said. 
    • “U.S. officials also released technical details of how the hacking operation worked, to help organizations identify and stop the group’s hacking activity.”
  • and
    • “Taiwan prosecutors charged nine people, including former employees of Nvidia and Super Micro Computer, with aiding the shipment of advanced artificial-intelligence servers to China, as Taiwan tries to limit technology reaching the mainland.
    • “The indictment charges eight of the individuals with crimes including breach of trust and forgery. One individual was charged in connection with allegedly siphoning funds from a company involved in the case.
    • “Washington is trying to block China from getting access to the latest Nvidia chips and has imposed export controls. That has pushed some Chinese companies to seek the chips through backdoor routes. Taiwan, which manufactures advanced computing components, is under pressure to find ways to clamp down.” * * *
    • “In the end, 74 of the servers were shipped to China through Hong Kong, Japan and Indonesia. Taiwan customs officials intercepted 56 servers, which were intended for shipment to Japan.”

From the cybersecurity breaches and vulnerabilities front,

  • Beckers Health IT reports,
    • “Boston Scientific said in an Aug. 27 stakeholder update that “a cybersecurity incident continues to affect certain information technology systems, and the company remains in a network outage with disruption to its operations.”
    • “The Marlborough, Mass.-based company detected the attack Aug. 25 and disclosed it to the U.S. Securities and Exchange Commission Aug. 26, saying the incident caused a global disruption to its operations, including its ability to process and ship customer orders.
    • “Two days later, Boston Scientific said its investigation shows no impact to the function of its implanted cardiac rhythm management devices, or CRM devices. The company also reported no disruption to those devices’ ability to transmit data and no interruption to physicians’ access to remote patient management data for CRM devices monitored before the outage began, with no evidence of increased cybersecurity risk transferring that data to EMR systems.
    • “New remote monitoring activations remain affected, however. For new cardiac implants other than insertable cardiac monitors, new communicators cannot be activated, so device data will not transmit to remote monitoring systems until activation resumes, though programmer interrogations are unaffected.”
  • and
    • “Anderson, S.C.-based AnMed says files copied during its cybersecurity incident may have included patients’ Social Security numbers, driver’s license numbers and financial account information.
    • “The health system said its investigation into the incident, first disclosed July 26, is nearly complete and has identified unauthorized copying of files from certain network systems.
    • “AnMed said patient electronic medical records, stored primarily in a secure cloud environment, were not affected. However, the health system said some patient care files stored locally on its network may have included names alongside demographic details such as address, date of birth, Social Security number and driver’s license or other government-issued identification.” * * *
    • “AnMed said it is working with federal and state law enforcement and third-party specialists, and it has reported the incident to HHS. The health system said it has no indication that any individual has experienced confirmed identity theft as a result of the incident. AnMed said it will send direct notices to affected patients once its review of the compromised files is complete.”
  • and
    • “Houston-based Nutex Health has disclosed that an unauthorized third party accessed and exfiltrated data from its computer network.
    • “The publicly traded microhospital operator said it recently detected the unauthorized activity and has engaged an independent third-party cybersecurity response team and forensic experts, according to an Aug. 24 SEC filing. The company activated its cybersecurity response plan, implemented containment measures and notified law enforcement.
    • “The company is still determining what data was compromised. Nutex said it continues to assess whether patient, employee, credentialed provider, confidential business and financial information, or intellectual property was accessed or acquired.”
  • The American Hospital Association News adds,
    • “Epic’s MyChart has shared examples from potential phishing schemes observed as recently this month that include email messages linking to a fake MyChart website displaying erroneous medical records and others notifying of a free “2026 Medicare Health Kit.” MyChart provided recommendations for healthcare organizations and patients to help prevent or mitigate impacts from potential scams. The company announced last month that it has witnessed an uptick in scammers using the MyChart name or logo to create deceptive emails, text messages, phone calls and websites that appear official.” 
  • Cyberscoop points out,
    • “The Bureau of Alcohol, Tobacco, Firearms and Explosives insists the cyberattack that it publicly disclosed Wednesday [August 26] was limited to investigation targets, and has not impacted other agency systems.
    • “ATF said it is responding to the breach, which first became public after a prolific ransomware group claimed it accessed the federal agency’s network “The incident involved a standalone computer system containing information about targets of ATF investigations,” Tanya Roman, ATF’s public affairs chief, told CyberScoop in an email.
    • “The standalone system was not connected to any other ATF systems, including any case management systems, laboratory systems, or eForms systems, and it was quickly shut down when the breach was discovered,” Roman added. 
    • “Qilin, a financially-motivated threat group composed of Russian-speaking operators, claimed responsibility for the attack, but its involvement hasn’t been independently confirmed. The group has claimed hundreds of victims from more than 60 countries since 2022 and became one of the most active ransomware threats globally by mid-2025, according to Halcyon.” 
  • Bleeping Computer lets us know,
    • “Healthcare and pharmaceutical distribution giant McKesson has disclosed a cybersecurity incident involving unauthorized access to third-party applications and data theft, with the ShinyHunters extortion group claiming it stole 284 million patient data records.
    • “McKesson is a major U.S. healthcare company and pharmaceutical distributor that provides medicines, medical supplies, technology, and services to healthcare providers and pharmacies.
    • “CyberInsider first reported the breach earlier today, and McKesson later disclosed it in a Form 8-K filing with the U.S. Securities and Exchange Commission.
    • “McKesson says it discovered the cybersecurity incident on August 25, 2026, and that its investigation remains in the early stages.
    • “Information about the incident, including any updates, is available on the company’s website at www.mckesson.com/cybersecurity,” McKesson said in its SEC filing“
  • Per a CISA news release,
    • “Most compromises do not rely on advanced techniques or cutting-edge tools. Cyber threat actors scan the internet looking for exposed, well-known software vulnerabilities to exploit. Basic security failures enable most compromises and organizations can reduce their risk by addressing these underlying weaknesses and prioritizing vulnerabilities for action based on the risk they pose.
    • “The CISA Vulnerability Review provides organizations with critical insights into the root causes of insecure software and practical steps they can take to address these flaws to prevent exploitation. Analyzing CISA and open source data from fiscal years 2024 and 2025, the review establishes a baseline of today’s vulnerability landscape before AI-enabled vulnerability discovery becomes more widespread. The review demonstrates the importance of Secure by Design principles in shifting cybersecurity efforts from reacting to threat actors to proactively fixing preventable software flaws.
    • “The review also identifies common software weaknesses that contribute to exploitable vulnerabilities and details practices software producers can use to prevent these weaknesses from recurring. By examining the patterns across vulnerability data, the review helps organizations focus on systemic improvements that can reduce entire classes of vulnerabilities rather than addressing individual vulnerabilities only after they are discovered.
    • “Additionally, the review shows organizations how to prioritize vulnerabilities for action using the framework outlined in Binding Operational Directive 26-04: Prioritizing Security Based on Risk. This framework evaluates vulnerabilities using four key criteria: exposure status, Known Exploited Vulnerability (KEV) Catalog status, potential for automated exploitation, and technical impact.”
  • Cybersecurity Dive adds,
    • “Two critical vulnerabilities in Microsoft SharePoint can be chained together to let an unauthenticated attacker execute code on a vulnerable server, according to a Monday blog post by researchers at VulnCheck.
    • “The sequence involves a critical authentication bypass vulnerability, tracked as CVE-2026-55040, and an improper input validation flaw, tracked as CVE-2026-63520. A proof of concept was previously disclosed on Aug. 11 by researchers at cybersecurity firm Rapid7. 
    • “Exploitation of CVE-2026-55040 was confirmed days after the Rapid7 disclosure. On Monday, VulnCheck researchers said the vulnerability on its own is not very impactful. To achieve maximum effect, they said, it needs to be chained with CVE-2026-63520. 
    • “The auth bypass is enough to prove some impact, but not enough to demonstrate the criticality of the full chain or build complete protections,” Vulncheck researchers said in their post.”
  • Per Infosecurity Magazine,
    • “Security researchers have claimed that over 9300 leaked AWS keys which surfaced between August 2022 and August 2026 are still active, including hundreds with full admin rights.
    • “Truffle Security said its scanners found 64,024 unique AWS key pairs across 431,875 public findings: git history, Hugging Face datasets, Docker images, package registries and CI logs.
    • “We took the 10,616 pairs with complete credentials and re-verified them, then enumerated what each key can tell us about its account: key age, attached policies, budgets, and last month’s spend,” the security vendor continued.
    • “No key material is published, and every owner we could identify is being notified.”
    • “Of the 10,616 pairs, 88% still authenticate. They include 768 corporate AWS keys which have full admin rights, Truffle Security said.”
  • Per Cyberscoop,
    • “Ubiquiti has patched 21 critical vulnerabilities, three of which were rated the highest severity possible, the communications product company said Wednesday [August 26] in a security bulletin.
    • In all, the company patched 22 vulnerabilities, with the last one rated “high,” it said in the bulletin.
    • Three of the vulnerabilities had a Common Vulnerability Scoring System rating of 10 out of 10. Each of them would allow a hacker to access privileges on the device or application.
    • All but one of the 22 vulnerabilities affect the UniFi line of products. The three maximum-security vulnerabilities are CVE-2026-77537, CVE-2026-77550 and CVE-2026-77554.
  • Per Bleeping Computer,
    • “PaperCut is warning that hackers are actively exploiting a vulnerability in all versions of its PaperCut NG and PaperCut MF print management software in zero-day attacks.
    • “The company says it is aware of confirmed attacks on customers and is urging organizations with Internet-exposed PaperCut Application Servers to immediately restrict access to the web interfaces to trusted IP addresses.
    • “PaperCut Software security response team is investigating active exploitation of a vulnerability affecting PaperCut NG and PaperCut MF,” reads an urgent security advisory published Thursday [August 27].
  • Per Dark Reading,
    • “A Chinese manufacturer has been planting backdoors inside of white-label routers sold in high volume around the globe.
    • “Shenzhen Zhibotong Electronics Co. Ltd. (ZBT) sells gobs of routers every year, if public evidence is to be believed. The 15-year-old company is the bestselling router manufacturer on Chinese e-commerce giant Alibaba.com, which lists its total annual output at 3.57 million units. Typically, those units are then sold to customers by companies other than ZBT, in countries like the Philippines, India, Canada, Australia, Germany, Bulgaria, Austria, Russia, and the US. According to its marketing, ZBT has exported its products to more than 50 countries and regions.
    • “On Aug. 6, Jacob Baines, chief technology officer (CTO) at VulnCheck, revealed that ZBT’s most updated router firmware contains a root-level backdoor. After a few more weeks of investigating, he discovered that, in fact, ZBT routers have contained a variety of backdoors dating several back years.”
  • and
    • “Fraudulent North Korean IT workers are getting better at infiltrating organizations, but a number of indicators can help organizations stay ahead.
    • “A new blog post from Huntress detailed a number of investigations the security firm conducted throughout 2026. Specifically, Huntress assisted several organizations this year in validating “suspicions that they’ve hired North Korean nationals posing as legitimate workers.”
    • “In recent years, operatives from the Democratic People’s Republic of Korea (DPRK) have infamously posed as IT workers — generally through fake or stolen identities — to get hired at companies. Once hired, these employees send their wages back to the North Korean regime, and possibly plant malware or steal data depending on the government’s needs. Blog post authors Jai Minton and James Maclachlan wrote that these agents “have significantly improved and increased their activity over the past few years.”

From the ransomware front,

  • Reuters reports,
    • “A ransomware group ​said on Friday [Augut 28] it was putting up for auction a trove of ‌data it stole from Berlin [Germany] state agencies, and city officials refused to pay.
    • The Rhysida group, which researchers say operates from Russia or Eastern Europe, said on its website it took 5.79 ​terabytes of data including 46,500 contracts as well as emails, phone numbers, passwords ​and classified information.
    • “The group said it was auctioning the data ⁠at a starting price of 30 bitcoin ($77,622) in just under seven days, showing a ​countdown timer on its website.” * * *
    • Broadcaster RBB reported on Thursday evening that Berlin had received ransom demands for an unspecified amount following the attack.
    • “The state ​of Berlin will not submit to extortion,” Berlin Mayor Kai Wegner and Berlin’s interior senator, ​Iris Spranger, said in a joint statement on Friday, before the ransomware group claimed the attack ‌on ⁠their website.”
  • Technology.org relates,
    • An affiliate of the new Aur0ra ransomware group used Cursor, the AI coding assistant now owned by SpaceX, to draft attack sequences in Russian across 28 recovered chat sessions dated 8 April to 21 May.
    • Named victims include Ghent-based hygiene and cleaning products maker Christeyns, German garage door manufacturer Teckentrup, Scotland’s Helideck Certification Agency and Louisiana title insurer Bayou Title.
    • Researchers counted more than 20 targeted organisations across nine countries, with domain-level or interactive access achieved at 17 of them between April and July 2026.
  • Safe State tells us,
    • “A ransomware affiliate has been posing as a specialist rescue outfit and contacting victims before their attacks became public. Researchers describe the operation as a ransomware recovery scam that drains payments away from the criminal groups the affiliate works for. The entity calls itself Ransom Busters LTD.” * * *
    • “Anyone targeted by a ransomware recovery scam meets it at the worst possible moment, with systems down and pressure building. Treat unexpected contact as part of the attack. Route the message to the incident response team straight away and preserve it as evidence instead of replying. A sender who knows about a breach nobody has announced is either involved in it or holds the data taken during it.
    • “Law enforcement and established response firms remain the reliable route through a ransomware incident. Verify anyone claiming to represent a security company through channels you found yourself. Never use the contact details supplied in the email. Treat any guarantee of data deletion as unenforceable, because no payment to a criminal party comes with proof that copies no longer exist.
    • “Distrust inside ransomware-as-a-service operations may produce more of this behaviour. Affiliates have every reason to look for income outside the revenue splits their employers set. So the ransomware recovery scam running under the Ransom Busters name reads less like an isolated curiosity and more like a preview. Anyone willing to defraud the criminal enterprise paying them has already answered the question of what a victim’s data is worth to them.”
  • SC Media informs us,
    • “Organizations may assume they are unlikely ransomware targets because they are not large, high-profile, or strategically important. But ransomware attackers are often motivated by economics, not prestige. That means organizations that consider themselves low-risk may be more attractive targets than they realize.
    • “The ransomware affiliate model rewards attackers for finding victims that are likely to pay, not necessarily those that are difficult or impressive to compromise. This can make mid-sized organizations and businesses that depend heavily on critical systems especially attractive targets.
    • “For security teams, this changes how ransomware risk should be assessed. Company size, industry, and public profile tell only part of the story. Attackers may care more about whether an organization can pay, how costly downtime would be, and how quickly it needs to restore operations.
    • “The key question is not how important your organization looks to an attacker, but how valuable a ransomware payment could be.”
  • Dark Reading adds,
    • “A sophisticated malware family has emerged onto the cyberthreat scene that might foreshadow ransomware attacks that are more successful than usual.
    • “Marcus Hutchins and his colleagues at Expel that discovered it named the malware “SynkLoader,” since it throws so many ideas (“everything but the kitchen sink”) at trying to sneakily dig into corporate systems. It uses some conventional strategies — like executing code in-memory, running a scheduled task, etc. — but layers on a few interesting, novel tactics that make social engineering particularly compelling, and malware analysis especially frustrating.
    • “The program is new, and how its creators intend to use it remains a mystery. But evidence in the code suggests that it might be the baby of a ransomware group or initial access broker (IAB), used to set the stage for follow-on ransomware.”

From the cybersecurity business and defenses front,

    • PYMNTS reports,
      • “Visa expanded the capabilities of its artificial intelligence-powered cyber risk management tool, Visa Vulnerability Agentic Harness (VVAH), to include not only discovery of vulnerabilities but also remediation and validation, the company said in a Thursday (Aug. 27) press release.
      • “Visa initially released VVAH in June after participating in Anthropic’s frontier AI cybersecurity initiative, Project Glasswing. While the first release of VVAH showed how AI can help security teams uncover vulnerabilities and assess exploitability, the latest release extends the workflow into remediation and validation of those vulnerabilities, according to the release.
      • “Visa also announced in the release that to help clients navigate the evolving threat landscape driven by AI, it has expanded its Visa Consulting and Analytics (VCA) Cybersecurity Advisory Practice to include new advisory services focused on assessing risk, prioritizing remediation efforts and strengthening resilience.
      • “The new advisory services include AI Cyber Leadership Education, VVAH-Informed Cybersecurity Maturity Assessment and VVAH Cyber Risk Prioritization and Roadmap, per the release.”
    • Cybersecurity Dive tells us,
      • “Operational silos, technological sprawl and cloud-platform blind spots are serious issues preventing organizations from spotting and repelling cyberattacks, the Cybersecurity and Infrastructure Security Agency (CISA) warned in a new report.
      • “Those were three of the main factors that allowed CISA’s red team to break into the networks of two unnamed partner organizations — one a government agency, the other a water utility — during recent simulated attacks. But although the red team was successful in both intrusions, it had a much harder time with one attack than with the other, a fact that CISA attributed to important differences in the targets’ operating procedures and use of technology.”
    • Security Week informs us,
      • “Palo Alto Networks’ Unit 42 team analyzed 405 malware samples tied to AI in some way, from ransomware partly written with the help of LLMs to installers that simply borrowed the name of a popular AI app.
      • “The researchers found that roughly 97% of the samples in the dataset never left a sandbox, research repository, or internal testing environment to reach a real target.
      • “Unit 42 cross-referenced the 405 file hashes against endpoint telemetry, network sessions forwarded for sandbox analysis, and internal alert records generated whenever a sample actually ran. Only 12 hashes surfaced on live endpoints, while a somewhat larger group (15-20 hashes) appeared in network sandbox traffic. Every one of the 12 samples detected on protected endpoints triggered a security alert.
      • “The samples that never reached production fall into three groups. The largest is proof-of-concept code built to demonstrate a technique: configured to target only local or private networks, filled with debug output no real attacker would leave behind, and uploaded once by a research lab or university. 
      • “A second group comes from organizations testing their own defenses against previously reported AI malware, identifiable by repeated uploads of the same file from the same source in a short window. A third group uses AI branding purely as bait, dressing up an ordinary payload as installers for well-known AI products with no actual AI functionality behind them.
      • “The 12 samples that did reach live endpoints spanned five malware families across three countries, with no concentration in any particular industry or region.” 
    • Beckers Health IT points out,
      • “Healthcare’s cybersecurity workforce problem may have less to do with finding more candidates and more to do with changing who health systems are willing to hire, how they develop them and what they do to keep them.
      • “Cybersecurity leaders at four health systems told Becker’s that continually competing for the same pool of experienced professionals is not a sustainable strategy as cyber risks expand and the skills needed to manage them become more complex.
      • “The cybersecurity workforce challenge has shifted from a talent shortage to a talent entry problem,” Trevor Martin, vice president, chief information security officer and interim chief technology officer at Madison, Wis.-based UW Health, said.
      • “Mr. Martin said there are many high-potential people trying to enter cybersecurity, but organizations frequently prioritize candidates who already have experience instead of creating pathways for people to gain it.
      • “Healthcare could benefit from hiring more heavily for aptitude, adaptability and an understanding of business and clinical operations, then developing those employees internally, he said. UW Health has found success moving talent from adjacent IT disciplines into cybersecurity roles and providing opportunities for employees to grow within the field.”
    • Dark Reading notes,
      • “As the “vulnpocalypse” reshapes the bug bounty industry, one class of researcher may face the greatest pressure: independent hunters who rely on midtier vulnerabilities — those worth roughly $10,000 to $50,000 — to make a living.
      • “It is no secret that large language models (LLMs) have led to a mass of bug reports and an increase in vulnerability discovery. It is also no secret that the platforms and companies that run much of the bug bounty industry have faced increased triage and payout times.
      • “Multiple bug bounty operators interviewed by Dark Reading report dramatic increases in submission volume over the past year. HackerOne CEO Kara Sprague says report volume has roughly doubled year over year. Dustin Childs, head of threat awareness for TrendAI’s Zero Day Initiative (ZDI), says the company’s submission rate went up 450% year-over-year in April of this year, although volumes have moderated since that peak. Bugcrowd CEO Dave Gerry said the firm saw a submissions spike of more than 300% during a three-week surge period, but “now it’s normalized where we’re about double the volume we saw historically.”
    • Per a National Institute of Standards and Technology news release,
      • “The final version of NIST Special Publication (SP) 1347, Cybersecurity Framework (CSF) 2.0 Informative References Quick-Start Guide, has published. Thank you to all who provided comments during the public comment period.  
      • “This publication explains what informative references are and how they support achieving the outcomes of the CSF 2.0. The guide introduces readers to NIST tools available for accessing, viewing, and using informative references for cybersecurity risk management, including direct download, the CSF 2.0 Reference Tool, and the Online Informative References Program. The document also provides two sample use cases along with examples of how artificial intelligence (AI) tools can support reference data use when implemented with continuous evaluation and improvement.” 
    • Here’s a link to Dark Reading’s CISO Corner.

    Friday report

    David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare–

    Simplicity is a virtue.

    From Washington, DC

    • Beckers Hospital Review reports,
      • “CMS said its enforcement efforts have resulted in blocking more than $1.6 billion in possibly improper Medicare lab payments throughout President Trump’s administration.
      • “An Aug. 28 CMS news release said these enforcement actions included savings of $732 million from 157 providers with revoked Medicare privileges, and a CMS investigation of 600 labs that resulted in 185 payment suspensions with more than $500 million in potentially fraudulent payments stopped. There were also 85 law enforcement referrals from a contractor that led to the prevention of $127 million in possibly fraudulent payments, and there was a recoupment of more than $276 million from 442 flagged overpayments to suspect labs.
      • “CMS had been using AI, among other analytics tools, to mine original Medicare claims. CMS focused on several kinds of lab fraud, such as labs billing for up-coded services. The news release said lab fraud can take place across services, including pathogen detection, high-complexity drug tests and genetic testing.
      • “Since the start of 2026, the CMS Fraud Defense Operations Center has been responsible for more than $371 million in Medicare suspended payments implicating 267 providers and suppliers.
      • “The news release comes amid CMS’ broader anti-fraud push across government programs, including Medicaid.”
    • FEHBlog observation — I find it hard to believe that these scoundrels would similarly attach FEHB plans for which private carriers hold the risk.
    • Beckers Payer Issues relates,
      • “The Labor Department is proposing a rule that would set criteria for employer associations to sponsor association health plans that qualify as employee welfare benefit and group health plans under the Employee Retirement Income Security Act.
      • “Received by the Office of Information and Regulatory Affairs Aug. 11, the rule is under review. ERISA outlines minimum standards for employee benefit plans.”
    • Beckers Behavioral Health adds,
      • “The Drug Enforcement Administration has submitted a final rule on telehealth prescribing of controlled substances to the White House for regulatory review.
      • “The DEA filed the rule Aug. 25 and listed it as “economically significant,” an Office of Management and Budget designation reserved for regulations expected to have an annual economic impact of at least $100 million.
      • “The rule would establish a long-promised special registration pathway allowing DEA-registered practitioners to prescribe controlled substances, including medications for opioid use disorder and attention-deficit/hyperactivity disorder, via telemedicine. It follows a proposed version of the rule that drew more than 6,400 public comments and would replace a series of temporary extensions the DEA has issued since pandemic-era flexibilities suspended the in-person visit requirement for such prescriptions. The agency’s latest extension of those temporary flexibilities runs through Dec. 31, 2026.”
    • The American Hospital Association News tells us,
      • “The Centers for Medicare & Medicaid Services’ six-month moratorium on the enrollment of new durable medical equipment, prosthetics, orthotics and supply companies in Medicare expired Aug. 27. CMS said that national provider enrollment contractors have resumed accepting initial enrollment applications from those suppliers. The agency said that suppliers should submit applications as soon as possible to allow contractors the maximum time for processing before the bidding window opens for the 2028 round of the DMEPOS Competitive Bidding Program.”
    • NCQA informs us,
      • “To align with the industry’s transition to digital quality measurement and the need for more streamlined data exchange, NCQA is creating a new HEDIS® measure for Transitions of Care (TRC) that uses the Electronic Clinical Data Systems (ECDS) reporting methodology.
      • “The current TRC measure assesses performance through a hybrid reporting methodology that combines administrative claims data and medical record review for a sample of eligible members. Because the hybrid TRC measure is included in the CMS Medicare Star Ratings, NCQA is coordinating this effort with CMS and other stakeholders.
      • “This measure is important because it evaluates care transitions, which present opportunities for missed connections that often require patients and families to fill in the gaps,” says Fern M., Director of Digital Quality Informatics at NCQA. “We know that health plans, technology vendors and policymakers are heavily invested in this measure, so we want to be as transparent as possible and allow organizations enough time to prepare for the changes.”
      • “The earliest implementation of the new ECDS TRC measure would be Measurement Year (MY) 2028, with the intention of retiring the hybrid version of the TRC measure in MY 2029.”

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

    • Govexec reports,
      • “Most federal employees would see their pay frozen at 2026 levels next year under an alternative pay plan issued by President Trump this week, though for the second straight year, federal law enforcement officers would receive a 3.8% increase.
      • “Trump first proposed the pay freeze as part of his fiscal 2027 budget proposal. Though the document was silent on federal employee compensation, officials with the Office of Management and Budget quickly clarified that its omission equated to a planned freeze for 2027.
      • “In a letter to House Speaker Mike Johnson, dated Thursday, Trump said increasing most federal employees’ pay would be “unacceptable and unfair” given the inflation that occurred under the Biden administration. Inflation actually has risen from 2.8% when former President Biden left office to 3.3% as of last month.
      • “I have therefore decided to set at zero the pay adjustment to be made for the 2027 pay year,” Trump wrote. “This decision will maintain fiscal responsibility without harming the government’s ability to recruit and retain well qualified employees.”
      • “But in the next paragraph, Trump said that for the second straight year, he instructed the Office of Personnel Management to issue a 3.8% increase in basic pay to federal law enforcement personnel next year, “to increase recruitment and retention” in those roles.”
    • Federal News Network adds,
      • “Up to 400 federal positions can now earn salaries of $400,000. A new final rule from the Office of Personnel Management allows the higher pay rates for hundreds of workers under an authority known as “critical position pay.” The authority is meant to help agencies recruit and retain highly qualified and specialized government workers in mission-critical roles. OPM’s final rule this week aligns with President Donald Trump’s orders earlier this year to use the pay authority for up to 400 national security roles.(Final rule on critical position pay authority – Office of Personnel Management)”
    • Per an OPM news release,
      • “US Office of Personnel Management (OPM) Director Scott Kupor joined Squawk Box on CNBC to discuss the Trump Administration’s efforts to recruit top tech talent and advance his vision for a more tech-driven federal government.”

    From the Food and Drug Administration front,

    • Cardiovascular Business reports,
      • “The U.S. Food and Drug Administration (FDA) is warning the public about an ongoing safety issue with certain intravascular catheters manufactured by Boston Scientific. These devices are being removed from the market, and Boston Scientific has officially decided to discontinue them going forward.
      • “The devices in question are Boston Scientific’s single-use Imager II Angiographic Catheters, which interventional cardiologists, vascular surgeons and interventional radiologists use to capture images of a patient’s peripheral vasculature. They are available in a variety of shapes and lengths. 
      • “This warning, which covers all Imagers II Angiographic Catheters, was put in place due to a manufacturing defect that can cause the catheter tip to degrade or detach from the rest of the device.”
    • MedTech Dive adds,
      • “Medtronic has recalled a pH monitoring capsule over a risk linked to 184 serious injuries, the Food and Drug Administration said Thursday.
      • “The recall, which the FDA communicated in an early alert notice, affects Bravo CF capsules that pose risks including perforation of the esophagus, obstruction of the airway and blood loss.
      • “Medtronic withdrew a subset of the newly recalled Bravo CF lots last year. The FDA said the same failures triggered both recalls, but the underlying causes of the problems are different.”
    • Fierce Pharma relates,
      • “In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk.
      • “On Friday, Lilly checked another item off that list as it secured FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE), including CV death, heart attack or stroke, in at-risk adults with Type 2 diabetes. With the nod, Lilly matches the 2020 approval Novo received for its diabetes treatment, Ozempic, to lower the risk of adverse cardiovascular events in at-risk patients.
      • “The label expansions came on similar timelines for the rivals. While Novo achieved its heart-helping endorsement three years after the FDA originally approved Ozempic, Lilly gained its expansion four years after the FDA first signed off on Mounjaro.”
    • Per a FDA news release,
      • “The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells. The excess cells can thicken the blood and increase the risk of cardiovascular issues, such as blood clots, stroke and heart attack.
      • “Mimrylo offers a new treatment approach for patients whose disease has not been adequately controlled with existing therapies. It is the first approved treatment for polycythemia vera that mimics hepcidin, a hormone that naturally regulates iron in the body. By limiting the iron available to make new red blood cells, Mimrylo helps reduce their overproduction and keep red blood cell levels under control. This novel approach offers a new option for patients who have not achieved adequate control with existing therapies.

    From the judicial front,

    • Per a Department of Justice news release,
      • “The Justice Department, together with the Drug Enforcement Administration (DEA), today announced a $50 million settlement with Walmart Inc. (Walmart) to resolve allegations that Walmart pharmacies illegally filled thousands of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA).” * * *
      • “The government’s complaint — filed on Dec. 22, 2020, and amended in 2022 in the U.S. District Court for the District of Delaware — alleged that since June 26, 2013, Walmart filled invalid prescriptions through the knowing actions of individuals on its compliance team and the knowing actions of its pharmacists. * * *
      • “In addition to the monetary payment announced today, Walmart has entered into a memorandum of agreement with DEA to address its future obligations in dispensing controlled substances. This agreement requires Walmart to establish a hotline for both employees and patients to report suspected illegal dispensing of controlled substances, proactively monitor the dispensing patterns of its pharmacies to identify and address potentially illegal dispensing, and establish a process to evaluate prescribers suspected of illegal prescribing.” * * *
      • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“
    • STAT News adds,
      • “A U.S. appeals court [panel for the 5th Circuit] ruled the Food and Drug Administration went through the proper process when it declared Novo Nordisk and Eli Lilly’s diabetes and obesity drugs are no longer in shortage, Bloomberg Law notes. The order is a loss for the Outsourcing Facilities Association, which representing large-scale compounders and challenged FDA decisions in the last two years that shortages ended for Novo’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound. That declaration restricted compounders from legally mass-producing versions of the drugs.”

    From the public health and medical / Rx research front

    • The Center for Disease Control and Prevention announced today,
      • “As of August 28, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
      • “National and regional COVID-19 activity is increasing. 
      • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
    • The American Journal of Managed Care reports,
      • “Children and young adults who were unvaccinated and infected with COVID-19 were at an increased risk of developing myocarditis, pericarditis, and mortality when compared with those who were vaccinated against COVID-19 with the Pfizer-BioNTech vaccine and not infected.1
      • “The recent findings published in Vaccine underscored the BNT162b2 vaccine’s favorable benefit profile, particularly for children and young adults. Prior research, also published in Vaccine, described COVID-19 vaccinations in general as reducing the risk of severe or prolonged disease—such as long COVID—in adolescents.2 These data, in tandem with the more recent study, provide ample evidence supporting preventive action against COVID-19 for children and adults.” 
    • The University of Minnesota CIDRAP adds,
      • “Giving children antiviral drugs within the first two days of the onset of flu symptoms reduces their likelihood of hospitalization by 81%, a study published last week in Pediatrics finds. 
      • “This protective effect remained robust among children aged 5 years or younger,” wrote the authors, led by scientists at Hsinchu Municipal MacKay Children’s Hospital in Taiwan.” * * *
      • “In an accompanying commentary, James Antoon, MD, PhD, MPH, and Kathryn Edwards MD, both of Vanderbilt University, noted that some pediatricians seem reluctant to use antivirals, adding that about 40% of high-risk pediatric flu patients go without them. 
      • “They urged more widespread use of the drugs. “The time has come for antivirals to be used in children with influenza,” they said. “With greater public hesitancy regarding vaccines, declining seasonal influenza vaccination rates, and recent influenza seasons with record pediatric deaths and hospitalizations, providers should strongly consider the use of antivirals in high-risk and hospitalized patients.” 
    • and
      • “Pennsylvania continues to see numbers climb in its ongoing measles outbreak, with 86 new cases added this week, which brings the total number of cases to 460 with 83 hospitalizations, according to an update today of the state’s measles dashboard. None of the cases have occurred in fully vaccinated people.” * * *
      • “For the third week in a row, Utah, which had the largest measles outbreak, reported no new cases. The state’s tally remains at 518. 
      • “The Georgia Department of Health confirmed four cases of measles linked to a daycare in the Atlanta area, with cases occurring in children who were unvaccinated or had not received the full measles, mumps, and rubella (MMR) vaccine series. 
      • “While the Centers for Disease Control and Prevention (CDC) typically update their measles numbers on Friday, a notification said the August 28, 2026, data have been delayed but will be updated as soon as possible. As of August 20, 2026, the CDC said there were 2,777 cases of measles in 47 states. Of those cases, 94% have been in unvaccinated individuals.”
    • Healio relates
      • “Rates of substance use fell among adolescents and young adults across most substances between 2021 and 2025, even as marijuana use increased among adults aged 26 years and older, according to the 2025 National Survey on Drug Use and Health.
      • “Substance use began declining among children aged 12 to 17 years prior to the COVID-19 pandemic, and those trends seem to be continuing among young adults aged 18 to 25 years in the new data, said Chris Jones, PharmD, DrPH, MPH, director of the Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration (SAMHSA).
      • “Coupling that with other surveys that show downward trends, that seems to be a durable effect that we’re seeing in recent years,” Jones told Healio.”
    • Cardiovascular Business tells us,
      • “Patients with peripheral artery disease (PAD) face a significantly higher risk of developing new-onset atrial fibrillation (NOAF), according to a new meta-analysis published in JACC: Advances.[1]
      • “The study’s authors reviewed data from more than 1,500 studies, landing on seven they wanted to focus on for this research. All studies were associated with a low risk of bias. The oldest study was performed in 2013 and the most recent was performed in 2022. All five studies were observational; five were prospective and the other two were retrospective. One study enrolled only women.
      • “In total, this meta-analysis included data from 763,919 patients. Approximately 56,000 of those patients had PAD as determined by ankle-brachial index (ABI) or a clinical diagnosis. In addition, there were approximately 26,000 cases of NOAF during follow-up. 
      • “Overall, researchers noted, PAD was linked to a 34% higher risk of developing NOAF. The hazard ratio was 1.34.” 
    • Genetic Engineering and Biotechnology News informs us,
      • “Researchers at the University of Toronto have developed a next-generation RNA therapeutic strategy that could have the potential to treat a wide range of genetic diseases that share certain types of disease-causing mutations. The team showed that chemically enhanced suppressor transfer RNAs (sup-tRNAs) combined with a lung-targeted delivery system can restore production of a critical protein in models of cystic fibrosis (CF) caused by “nonsense mutations.”
      • ‘These mutations introduce a premature stop signal into the genetic instructions for making a protein. The result is that cells may produce little or no full-length functional protein, disrupting vital functions in ways that are difficult to treat.
      • “The researchers, led by Bowen Li, PhD, an associate professor in U of T’s Leslie Dan Faculty of Pharmacy, engineered sup-tRNAs to help cells read through these premature stop signals introduced by nonsense mutations into the mRNAs, and complete production of full-length proteins that would otherwise be truncated or absent. They tested the approach in bronchial epithelial cells, mouse models, and patient-derived cystic fibrosis organoids and found that the chemical modifications increased the readthrough of premature termination codons and tRNA aminoacylation, prolonged the tRNAs’ functional activity, and reduced innate immune activation. Moreover, the approach restored CFTR protein production and function across cell, animal, and patient-derived organoid models. The researchers also found that the approach can be combined with existing cystic fibrosis drugs, suggesting the potential for combination therapy.”
    • The New York Times points out,
      • “A one-time gene-editing treatment to lower cholesterol had long-lasting effects a year later, scientists reported on Friday. The results highlight the potential to treat even common diseases by altering people’s genes.
      • “In the small study, which followed only 15 patients, participants who got the highest dose saw their cholesterol levels plunge by half — and stay that way for a year. The results were presented at the European Society of Cardiology Congress and published in the New England Journal of Medicine.
      • “Earlier this year, a similar “one-and-done” clinical trial that used a different gene-editing approach also reported significantly reduced “bad” LDL cholesterol in 35 patients.
      • “Both efforts are early safety studies and are years away from becoming an option people will be offered in a doctor’s office. But an approach that once seemed almost outlandishly far out has inched closer to reality as evidence accrues that it works, and that the results stick.”

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

    • Beckers Hospital Review reports,
      • “Health system CEOs are navigating a growing list of financial pressures, including Medicaid coverage and reimbursement changes under HR 1 and ongoing payment and policy challenges surrounding the federal 340B drug discount program. Site-neutral payment adds another consideration as health systems weigh where to invest and deliver care. 
      • “At Winchester, Va.-based Valley Health, concerns about site-neutral payment are already influencing where the system adds outpatient capacity. President and CEO Mark Nantz said Valley Health is keeping new outpatient sites on its hospital campuses in part to preserve hospital outpatient department rates. Peter Slavin, MD, president and CEO of Los Angeles-based Cedars-Sinai, said eliminating the outpatient payment differential entirely could cost Cedars-Sinai Medical Center about $200 million annually. J. Stephen Jones, MD, president and CEO of Fairfax, Va.-based Inova, said the policy has not changed where the system invests, but it has prompted greater focus on site of care when evaluating projects.
      • “It disrupts the financial model that includes things like 340B, hospital outpatient department rates and Medicare disproportionate share,” Mr. Nantz told Becker’s. “All of those things together help us cobble together a pretty fragile financial model. And so if any part of that financial model, somebody starts pulling the string on it, it unravels pretty fast.”
    • Beckers ASC Review lets us know,
      • “Hospital-employed physicians command significantly higher commercial reimbursement rates than independent peers across every specialty, with a $92 average gap in blended evaluation and management rates in the Chicago market, and the cost difference extends well beyond the professional fee, according to 2026 Trilliant Health price transparency data.
      • “Employed urologists averaged $263 per blended E/M visit compared with $141 for independent urologists, a $122 gap. Employed gastroenterologists averaged $240 versus $141 for independents, employed orthopedic surgeons averaged $260 versus $154, and employed cardiologists averaged $234 versus $144. Even the smallest gap, primary care at $196 employed versus $154 independent, represents a 27% premium for identical services.
      • “The stakes are significant given how many physicians have moved into hospital employment. Approximately 253,000 physicians became employees of hospitals or corporate entities between January 2018 and January 2026, and 79.5% of physicians who sold their practices to a hospital or health system cited the ability to negotiate higher payment rates as an important or very important reason for doing so.”
    • Per Beckers Physician Leadership,
      • “More than 60% of physicians are not satisfied with how the medical profession deals with work-life balance, according to a new report from Medscape. 
      • “State of the Medical Profession Index Report 2026,” published Aug. 28, surveyed more than 1,000 physicians across 29 specialties to rate their satisfaction with how the profession is dealing with key issues, and their optimism levels for improvement going forward.” 
    • Healthcare Dive relates,
      • “Virtual healthcare company Sword Health is planning to acquire digital mindfulness company Headspace, according to a regulatory filing.
      • “Headspace’s parent company OrangeDot is seeking to be acquired by Sword in an all-cash deal, the company told regulators in Massachusetts on July 22.
      • “The acquisition is expected to close on Sept. 14. The financial terms of the deal were not disclosed. Neither Headspace nor Sword Health responded to a request for comment by publication time.”
    • Managed Care Executive tells us,
      • “Cancer biosimilars are associated with lower costs for both insurers and patients, according to a new study by researchers at the UCLA Health Jonsson Comprehensive Cancer Center. Patients with cancer who exclusively used biosimilars had average monthly costs that were $3,820 lower for insurers and $39.50 lower out-of-pocket costs compared with patients who exclusively used the branded biologic drugs, according to a study published today in JAMA Oncology.“
      • “Although the savings were substantially greater for insurers than for patients, even modest reductions in out-of-pocket costs may be meaningful for people facing the financial challenges of cancer care,” senior author Tina Shih, Ph.D., director of the Cancer Health Economics Research Program at the UCLA Health Jonsson Comprehensive Cancer Center, said in a news release. Shih is also a professor of Health Economics in the Department of Radiation Oncology.”
    • Fierce Pharma informs us,
      • “Twenty weeks into its launch, Eli Lilly’s Foundayo has finally exceeded 40,000 in weekly prescriptions, according to IQVIA data cited by Citi. The oral GLP-1 drug posted 40,862 scripts last week, bouncing back from a small dip the week prior. Still, the drug’s scripts level is no match for the roughly 57K that Novo Nordisk’s Wegovy pill garnered at week 6 of its own launch.
      • In its 33rd week of launch, the Wegovy pill booked roughly 175K scripts, slightly down from 176K, per IQVIA. The share of the oral version of semaglutide in all Wegovy obesity scripts was flat week over week at 35%. All told, across the pill and the injectable, Wegovy’s weekly scripts were a little over 500K, down 0.8% sequentially.
      • “As Jefferies analysts observed in an Aug. 21 note, Wegovy has been relatively flat since the Medicare GLP-1 Bridge program began July 1.
      • “Overall, the roughly 60%-40% obesity market share split between Lilly and Novo remained stable, as Lilly’s Zepbound held its ground as the most popular drug.”

    Thursday report

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

    Simplicity is a virtue.

    • Fierce Pharma points out,
      • “The Trump administration looks set to unveil a new slate of most-favored-nation (MFN) drug pricing deals with several mid-sized biopharma companies, according to Bloomberg.
      • “The announcement is expected on Monday [August 31, 2026], the news service reported this week, citing sources familiar with the plan. Drugmakers that have agreed to the voluntary deals are expected to provide their products to state Medicaid programs at prices aligned with those they charge in foreign countries.  
      • “In exchange, the companies could secure tariff relief and may win exemption from Medicare pilot discount programs that are in the works, Bloomberg wrote.” 
    • Per a Centers for Medicare and Medicaid Services news release,
      • “The Trump Administration announced today that a $93.3 million investment is being delivered to help rural hospitals advance new state-of-the-art models of care and improve health outcomes for Georgians through the federal Rural Health Transformation Program (RHTP). 
      • “This investment will help 87 rural hospitals prepare for value-based care, expand training and recruitment for nurses, EMTs and paramedics, and improve access to maternal and behavioral health services, newborn screening, and other critical health services through telehealth, transportation and expanded care networks. It will also bring next-generation technology to rural communities—including surgical robotics, dementia care capacity, and telehealth infrastructure—to modernize care. By strengthening and expanding rural care, this funding will also help retain health care professionals in rural Georgia. This investment will strengthen rural hospitals, expand telehealth and healthcare access, build dementia care capacity, and grow the rural healthcare workforce through technology-enabled care initiatives across the state. With these investments, Georgia has now committed the full $218 million awarded to the state for its first year of funding through the RHTP.”
    • The American Hospital Association relates,
      • “The Centers for Medicare & Medicaid Services has released a fact sheet and FAQs on the 340B Part D claims data repository that will go live Oct. 1. Data submissions would currently be voluntary for 340B hospitals. However, the agency recently proposed to make data submissions mandatory starting in 2027. The fact sheet and FAQ provide an overview of the repository along with other key details.”
    • Per a Health and Human Services Department news release,
      • “The U.S. Department of Health and Human Services (HHS) today announced [in the news release] the nine winners of the 2026 KidneyX EMPOWER: Living Link Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them. The challenge was run through the Kidney Innovation Accelerator (KidneyX), a public-private partnership between HHS and the American Society of Nephrology (ASN).
      • “Every American waiting for a kidney deserves the best chance at a longer, healthier life,” said HHS Secretary Robert F. Kennedy, Jr. “Living kidney donation saves lives, yet too many willing donors face barriers that should not exist. We are removing those barriers and backing innovators with practical solutions that support donors, strengthen transplant care, and give more Americans a chance to live.”
    • The International Foundation of Employee Benefit Plans reports,
      • “The Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments) released Affordable Care Act (ACA) and Health Insurance Portability and Accountability Act (HIPAA) Implementation Frequently Asked Questions (FAQs) Part 74 addressing health-contingent wellness programs, including tobacco-related wellness programs. The FAQs cover completion of reasonable alternative standard and disclosure requirements. 
      • “The new guidance comes after tobacco-related wellness programs have been the subject of recent class-action lawsuits challenging the tobacco surcharges some employers add to premiums for their group health plans through workplace wellness programs. The FAQs released today announce the Departments’ approach to enforcement for health-contingent wellness programs that reward an employee if they satisfy a standard related to a health factor.
      • “Until further guidance or regulations are issued, the departments will not take enforcement action against plans or issuers that do not give employees the wellness program reward retroactively to the beginning of the plan year after the employee completes a reasonable alternative standard. Under the terms of the enforcement relief in these FAQs, plans and issuers only need to provide the reward prospectively, from the point where the employee completes the alternative standard, if retroactive rewards are not otherwise provided.”
    • Beckers Hospital Review tells us,
      • “Medicare’s GLP-1 Bridge program is seeing early uptake at major retail pharmacies, with CVS and Walgreens each filling about 100,000 prescriptions less than two months after the program launched in July, according to an Aug. 26 NPR report.
      • “We expected there would be uptake,” Walgreens’ chief pharmacy officer Rick Gates told NPR. “I think there’s been a little bit more uptake than we even expected.”
      • “Walgreens stocked additional Wegovy, Zepbound and Foundayo ahead of the launch but has not experienced supply issues. Walmart said Bridge prescriptions have also increased week over week and have been filled at more than 5,000 Walmart and Sam’s Club pharmacies nationwide.
    • The No Suprises Act’s (“NSA”) regulating agencies, which includes OPM, corrected errors found in the final Independent Dispute Resolution rule published in the Federal Register on June 5, 2026.

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

    • Federal News Network reports,
      • “Artificial intelligence may become a more prominent part of the federal hiring process, following new guidance from the Office of Personnel Management.
      • “In a memo Thursday, OPM encouraged agencies to more widely adopt AI tools in their recruitment efforts. Without increasing AI use, agencies may be compromising the effectiveness and efficiency of the federal hiring process, OPM said.
      • “Despite 2025 guidance from the Office of Management and Budget defining “high-impact” standards for AI usage, agencies have been “overly cautious” about using the technology in hiring, said Adam Starr, OPM’s CIO and a senior advisor.
      • “Too often, agencies were defaulting to the view that any use of AI in hiring was subject to the high-impact standard. In reality, that is not the case,” Starr said Thursday in a blog post. “Instead, the inclusion of AI as a complement to human judgment is not only acceptable but leads to better outcomes.”
    • Tammy Flanagan, writing in Govexec, advises “Want to retire at the end of 2026? Start planning now.”
      • OPM is still working through a sizable retirement backlog, and year-end retirees have plenty to sort out before they leave federal service.

    From the Food and Drug Administration front,

    • The American Hospital Association reports,
      • “The Food and Drug Administration has issued an early alert for all automated Impella controllers by Abiomed following an issue that has caused three deaths and 37 serious injuries as of Aug. 17. The alert was issued due to the products experiencing purge cassette recognition issues resulting from failures of the purge flag component within the purge pressure sensor assembly. Abiomed sent a letter to all affected customers recommending the devices be removed from where they are used or sold.” 
    • The Washington Post relates,
      • “The Food and Drug Administration on Thursday green-lit updated coronavirus vaccines for higher-risk Americans, such as older adults and people with at least one underlying health condition, vaccine manufacturers announced.
      • “The approved shots from vaccine manufacturers Pfizer-BioNTech and Moderna, which make mRNA-based vaccines, have an updated formulation aimed at better targeting the coronavirus variants circulating around the country. The FDA also cleared an updated vaccine from Sanofi, which doesn’t use mRNA-based technology and was originally licensed by Novavax, a Sanofi spokesperson confirmed. The companies said the vaccines are expected to be available in the coming days.”
      • “Most Americans typically get vaccinated against the coronavirus at retail pharmacies.
      • “Pharmacies are actively preparing to receive the updated shots, so they can begin vaccinations as soon as they receive shipments and all state requirements are met, according to Brigid Groves, a vice president at the American Pharmacists Association.”
    • Reuters tells us,
      • “The U.S. Food and Drug Administration said on Thursday it approved a ​treatment from Roivant (ROIV.O) and partner Priovant Therapeutics for a rare disease, ‌making it the first oral drug for the condition affecting skin and muscles.” * * *
      • “Branded as Lisraya, the drug was approved for ​dermatomyositis, a condition that causes painful skin rashes and progressive muscle weakness ​and, if untreated, can severely reduce quality of life.”
    • CNBC informs us,
      • “The Food and Drug Administration approved a once-daily HIV pill from Gilead that could help simplify care for some patients whose virus is already under control but who remain on complicated treatment regimens. 
      • “The tablet combines bictegravir, the backbone of Gilead’s blockbuster HIV pill Biktarvy, with lenacapavir, a centerpiece of the company’s long-term strategy for HIV treatment and prevention. 
      • “The new pill is also aimed at people who are doing well on a single-tablet regimen, including Biktarvy, and want to switch to a new treatment.”

    From the judicial front,

    • Michelle Roberts, an attorney, lets us know,
      • In Central States v. McClain [decided August 26, 2026, a panel of the U.S. Court of Appeals for the] Seventh Circuit held that ERISA does not preempt Arkansas Insurance Department Rule 128. Applying Rutledge, the court treated the Rule’s dispensing fee requirement as a permissible cost regulation rather than a mandate dictating plan choices, and under Gobeille, it held that the Rule’s reporting requirement fell within the exception for reporting incidental to an unpreempted state law. The panel affirmed dismissal at the pleading stage while expressly reserving whether Congress’s new pharmacy-compensation reporting provision under 29 U.S.C. § 1185o will change the analysis once it takes effect.
    • In National Infusion Centers v. Kennedy, also decided August 26, 2026, held
      • “The Plaintiffs challenge the constitutionality of the Drug Pricing Program created by the Inflation Reduction Act of 2022. They claim violations of the nondelegation doctrine, the Eighth Amendment’s Excessive Fines Clause, and the Fifth Amendment’s Due Process Clause. The district court granted the Government’s motion for summary judgment. We AFFIRM.”
    • Govexec reports,
      • “The Equal Employment Opportunity Commission voted 2-1 Wednesday to propose new regulations that would overhaul how federal workers may pursue workplace discrimination claims, removing employees’ right to request a hearing before an administrative judge and outright banning class action cases outside of federal court.
      • “Currently, federal workers alleging discrimination at their employing agency must undergo up to 90 days of pre-complaint counseling, which includes informing employees about the EEO process and sometimes mediation, after which their agency will conduct an internal investigation. Once that is complete—or after 180 days—the employee may request a hearing before an EEOC administrative judge.
      • “But under a new proposed rule, set for publication Friday in the Federal Register, complainants would no longer go through pre-complaint counseling, instead directly filing their complaints to EEOC within 60 days of the alleged discriminatory incident. And they would no longer be guaranteed a hearing; that decision would instead be made by officials within the EEOC’s Office of the Federal Sector.
      • “Under the plan, complainants would have to affirmatively request a hearing when they appeal a final agency decision, and in some cases submit an explanation justifying its need. Those who do receive a hearing under the new process would no longer have the benefit of discovery, a practice by which parties can request and receive documentation related to the case.
      • “Additionally, while employees with similar allegations of discrimination may elect to have their individual complaints processed “jointly,” EEOC would cease consideration of class action cases. If employees wish to proceed as a class, they would each have to exhaust their individual cases before the agency and then file a class action lawsuit in federal court.”

    From the public health and medical / Rx research front

    • The Wall Street Journal reports.
      • “[H]ow much water do we really need to drink a day? The question feels more pressing than ever given rising temperatures, heat waves and the fact that chugging water is almost a competitive sport these days. The answer may be less than you think and varies based on your size, health, activity level and where you live.” * * *
      • “The most cited recommendations for water come from the National Academy of Medicine, which calls for a total daily fluid intake of 3.7 liters for men and 2.7 liters for women. 
      • “But here’s the thing: That is total fluid intake, not water specifically. And here’s the other thing: Roughly 20% of our fluids come directly from food, studies have found.
      • “That leaves roughly two liters of fluids daily for women and three for men, says Kavouras. That translates to about 68 ounces and 101 ounces from beverages. 
      • “Stavros Kavouras, founding director of Arizona State University’s Hydration Science Lab in Phoenix and DrHydration on social media. estimates the average pour of water in the U.S. is 12 to 16 ounces. So that works out to about four to six glasses of fluids daily for women and six to eight for men.”
    • The New York Times relates,
      • “Scientists have uncovered a wealth of clues about how genetic mutations lead to severe forms of autism, offering opportunities for testing drugs that could treat the condition, according to a study published Thursday.
      • “The researchers charted how mutations change the way proteins work together in cells, altering the development of the brain.
      • “This is making maps of unknown territories that’s really necessary to move the biology forward,” said Dan Geschwind, a neurogeneticist at the University of California, Los Angeles, who was not involved in the study.
      • “Researchers have been studying autism for over 80 years, but it has only been in recent years that they have been able to explore its molecular biology. One reason that progress has been so slow is that autism is not just one condition, but a broad constellation of them.”
    • Radiology Business adds,
      • “A new analysis details the prevalence of amyloid-related imaging abnormalities (ARIA) on MRI in individuals who are being treated with new Alzheimer’s disease therapies. 
      • “Kisunla (donanemab) is an FDA-approved intravenous monoclonal antibody infusion for early symptomatic Alzheimer’s disease; it works by essentially scrubbing amyloid deposits from the brain, which in turn helps reduce cognitive symptoms associated with the neurodegenerative disease. While effective, a known side effect of the treatment is that is causes ARIA. 
      • “Symptoms of ARIA include headache, confusion, dizziness, vision changes and nausea, but if left unchecked, the symptoms can become severe. This is why experts (and the FDA) recommend scheduled MRI brain scans on individuals being treated with modern monoclonal antibody infusion treatments. 
      • “Now, a new study is offering detailed insight into how common ARIA is in individuals being treated with donanemab. Published in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitorin, the analysis suggests that up to 20% of patients may exhibit signs of ARIA on imaging.” 
    • MedPage Today tells us,
      • “Despite recommendations by the U.S. Preventive Services Task Force and the American Cancer Society, cervical cancer screening rates are declining.
      • “From 2005 to 2023, the proportion of women ages 21 to 29 never screened for cervical cancer increased from 12.5% to 31.9% (average annual percentage change [AAPC] 5.2%), with a notable increase from 2010 to 2023 (AAPC 7.9%).
      • “Regional-stage and distant-stage cervical cancer incidence has increased by 2.3% and 2.6%, respectively, per year among women ages 30 to 64 since 2017.”
    • and
      • “Almost 80% of patients with early-stage rectal cancer avoided surgery for a year or longer when treated with chemoradiation in a randomized trial.
      • “The organ-preservation strategies of chemoradiation and radiotherapy were both associated with few adverse events without sacrificing oncologic control.
      • “Longer follow-up is needed to determine long-term disease control and safety.”
    • and
      • “People who experience an opioid overdose are at greater risk of death, but data on which opioid agonist treatments are most effective in supporting this high-risk population are limited.
      • “In a retrospective cohort study of opioid overdose survivors, starting methadone was associated with a reduced risk of death during the subsequent year compared with starting buprenorphine-naloxone.
      • “In an accompanying commentary, experts questioned whether methadone is truly “intrinsically superior” to buprenorphine-naloxone.”

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

    • Beckers Payer Issues reports,
      • “Mona Chitre, PharmD, will serve as the market president for the newly created employer and government markets segment under Optum Rx, UnitedHealth Group’s pharmacy benefit manager.
      • “Dr. Chitre will begin her role Aug. 31, according to an Aug. 26 LinkedIn post. She said the role unifies the commercial, health system, coalition, labor and trust, and public sector businesses.
      • “Dr. Chitre most recently founded and was the president of Candesa Pharmacy Solutions, under The Lifetime Healthcare Companies. Under the same parent, she previously was Excellus BlueCross BlueShield’s chief pharmacy officer, according to her LinkedIn profile. She brings 26 years of experience across healthcare and pharmacy, she said.”
    • Fierce Healthcare relates,
      • “Cigna is looking to better link medical and supplemental benefits for its members, and has unveiled a new employer benefit that aims to further that goal.
      • “The insurer’s new Medical with Smart Coverage plans will be available as an option for employers with 500 to 2,999 employees that currently offer a high-deductible health plan. Cigna intends to expand access further in 2028, according to an announcement.
      • “The plan is designed to offer members support in managing unexpectedly high costs should they occur. Enrollees can access up to $7,000 in supplemental cash benefits that they can use during these health events to cover key needs such as transportation, child care or hotel stays.”
    • Beckers Hospital Review non-exhaustively lists “68 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
    • and tells us
      • New Haven, Conn.-based Yale New Haven Health System reported operating income of $33 million (0.5% operating margin) through the third quarter of 2026, up from an operating loss of $40.2 million (-0.7% margin) during the same period last year, according to its Aug. 25 financial report. 
    • and
      • “Pittsburgh-based UPMC recorded an operating loss of $18.3 million (-0.2% operating margin) for the second quarter of 2026, down from operating income of $111.2 million (1.3% margin) during the same period last year, according to its Aug. 27 financial report.”
    • Fierce Healthcare adds,
      • “Corewell Health showed its plans for two major hospital campus expansions that will run the Michigan nonprofit system $1.7 billion.
      •  “As our communities grow and patient needs become more complex, we are building the capacity, technology and care environments needed today for our patients and team members for many years to come,” President and CEO Tina Freese Decker said in the organization’s Thursday announcement. 
      • “The larger of the two projects is coming to Corewell Health Butterworth Hospital in Grand Rapids. The 780,000-square-foot, 11-story tower will include a new ED, 180 private patient rooms, 17 operating rooms and a hyperbaric chamber, Corewell said.” * * *
      • “The other new tower comes with a $440 price tag for the organization and will be built at Corewell Health Beaumont Troy Hospital, which serves a “rapidly growing” community and is also “consistently” above 90% capacity.”
    • and 
      • “Healthcare navigation platform Transcarent launched on Tuesday a bundled payment model for cancer therapies.
      • “The payment model, which the company touts as a first-of-its-kind, supports bispecific T-cell engager (BiTE) and CAR T therapies. Transcarent connects its members to leading oncology providers across various settings, including academic medical centers and high-quality community-based cancer care sites.
      • “Advanced cancer therapies are changing what’s possible for patients, but they’re also creating new challenges for employers trying to manage costs and access,” said Snezana Mahon, Transcarent’s president, in a statement. “This model gives employers more predictable costs while helping Members receive expert care closer to home without sacrificing quality.”
      • “The model enhances Transcarent’s Centers of Excellence (COE) program through easier access and navigation of more affordable care—offering potential savings of up to $150,000, executives say.
      • “Moreover, members undergoing treatment through the COE network are supported throughout their journey by certified oncology nurse navigators (ONNs).” 
    • Beckers Physician Leadership informs us,
      • “More than half of U.S. physicians, 59.4%, are now employed by a hospital or health system, according to a new analysis from Trilliant Health that assessed 700,000 physicians across the country.
      • “Here are four more things to know
        • “1. The hospital-employment rate is highest in the Midwest at 67.2% and lowest in the South at 52.4%, with the Northeast at 62.9% and the West at 60%. Multiple factors are driving the trend, with declining Medicare reimbursement chief among them. 
        • “2. The AMA estimates Medicare physician pay has declined 33% in real terms between 2001 and 2025 while practice costs rose 59% over the same period. 
        • “3. Among physicians who sold their practices to a hospital or health system, 79.5% cited the ability to negotiate higher payment rates as an important or very important reason for doing so. 
        • “4. Approximately 253,000 physicians became employees of hospitals or corporate entities between January 2018 and January 2026, with an additional 4,200 absorbed by insurers, private equity firms and pharmacy chains between 2024 and 2025.”

    Wednesday report

    David Ermer–FDA, Rx coverage, U.S. Healthcare, Uncategorized–

    Simplicity is a virtue.

    Quick Hits

    • Reuters adds,
      • “About 14% of employers in the United States have already or plan to drop GLP-1 drugs in 2027, as companies see ​rising healthcare costs, according to a survey released on Tuesday by the Business Group ‌on Health.
      • “Healthcare costs are set to increase 9.2% if employers do not make changes to manage costs in 2027, up from 8.5% in 2026, the group said. Two-thirds of employers surveyed said they saw rising utilization of ​the drugs.”
    • Healthcare Dive reports,
      • “The federal process for insurers and providers to settle disputes over out-of-network bills appears to be dramatically adding to U.S. healthcare spending, fueling calls for reform.
      • “That mechanism, set up by the No Surprises Act, has generated more than $22.4 billion in extra costs over just four years, according to new estimates from Georgetown University. That’s a significant acceleration from researcher’s past estimates of $5 billion in extra costs over the dispute resolution process’ first two years.
      • “But dispute volumes and total awards have continued to increase since — a worrying finding, given costs could push premiums up. The researchers urged policymakers to revisit the NSA.
    • The Wall Street Journal reports,
      • “For four decades, cancer researchers fought to disable a stubborn mutation that made pancreatic cancer a death sentence—to little avail. 
      • “Now, doctors have a medicine that targets the mutation. The Food and Drug Administration’s approval of the drug from Revolution Medicines on Wednesday marks a milestone in treatment of one of the most intractable kinds of tumors. 
      • “This is life-altering,” said Carla Kurkjian, an oncologist at Mercy Hospital in Oklahoma City, who wasn’t involved in the studies. “Not just for patients, as far as helping them extend their lives beyond anything we’d ever seen, but for us as physicians, to be able to have a different conversation than we’ve had for so long.”
      • “The drug, called Rasonque, helped subjects in a late-stage study live more than 13 months, nearly twice as long as those on chemotherapy alone. When presented at the world’s largest gathering of cancer researchers last spring, the results drew a nearly minute-long standing ovation.” 
      • “Yet the drug does have side effects, including a harsh rash across the body and gastrointestinal issues. Former Nebraska Sen. Ben Sasse, who went public in the spring with what he described as a significant reduction in his tumors while in a clinical trial of the drug, appeared on television with his face covered in red blotches.
      • “RevMed said the drug will cost $39,800 a month, or more than $477,000 a year.
      • “Wall Street expects Rasonque, which was approved for use in patients for whom other treatments failed, to be a big seller. The drug could generate more than $20 billion in annual sales, according to pharmaceutical commercial intelligence firm Evaluate, if the drug proves to work safely in earlier stages of the disease and with different types of cancers.”
    • The New York Times adds,
      • “The Food and Drug Administration’s approval on Wednesday of a new drug for pancreatic cancer marked the end of a long quest to develop a medicine that can hit one of cancer’s most elusive targets.
      • “Researchers hope the new drug is just the beginning, opening a new chapter in treatment for a range of cancer types.
      • “At least 79 drugs that take a similar approach are being tested in 238 clinical trials worldwide, according to one tally by academic researchers.
      • “Large drugmakers like Eli Lilly, Pfizer, Amgen and AstraZenecaare among the companies racing to develop their own medicines that work like the new drug, daraxonrasib, which is made by Revolution Medicines and will be sold as Rasonque.”
    • STAT News notes,
      • “The newer shingles vaccine has been turning heads since its link to lower dementia rates was reported two years ago. Now the same research team behind that observation has found an association between receiving the Shingrix shot and a reduced risk of heart disease.
      • “There have been signals before of cardiovascular benefits in people who got the newer, recombinant vaccine to prevent shingles, a painful, often serious flare-up in older people of the chickenpox virus from childhood. Those who got Shingrix were less likely than unvaccinated people to have heart attacks, strokes, or heart failure.” * * *
      • “Although the benefits are relatively small on an individual basis, millions of people receive shingles vaccination, meaning that even a small cardiovascular benefit could translate into a substantial number of cardiovascular events prevented at a population level,” Mark Russell, clinical senior lecturer and consultant rheumatologist of King’s College London, said in a statement shared by the Science Media Centre.”