Tuesday report

CMS

Tuesday report

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

Simplicity is a virtue.

From Washington, DC

  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, September 15, 2026, at 10:00 AM ET to consider Gerard Klomp to be Deputy Secretary of Health and Human Services (HHS); James Gadwood to be Chief Counsel for the Internal Revenue Service (IRS) and an Assistant General Counsel in the Department of the Treasury; Ge Bai to be an Assistant Secretary of HHS; and Andrew A. De Mello to be a Judge of the United States Tax Court.” * * *
    • “Opening statements and a live video of the hearing will be available on www.finance.senate.gov.”
  • Beckers Hospital Review reports,
    • “HHS has selected four senior leaders for the FDA, including directors for the agency’s drug, biologics and tobacco centers and its first deputy commissioner focused on technology and artificial intelligence.
    • “Jared Seehafer was selected as the FDA’s first deputy commissioner for technology and artificial intelligence, according to a Sept. 8 HHS news release. He will serve as the agency’s senior leader for technology, software and AI and lead FDA-wide strategy and priorities in those areas.
    • “Michael Davis, MD, PhD, was selected as director of the Center for Drug Evaluation and Research after serving as acting director since May, when his predecessor was fired days after the agency’s commissioner stepped down. He will lead the center responsible for helping ensure safe, effective and high-quality drugs are available to the public.
    • “Karim Mikhail was selected as director of the Center for Biologics Evaluation and Research after serving as acting director, a post that has seen frequent turnover over the past year and a half. The center regulates biological products, including vaccines, blood and blood products and cellular and gene therapies.
    • “Bret Koplow, PhD, was selected as director of the Center for Tobacco Products after serving as acting director. He has served at the FDA since 2011.”
  • Behavioral Health Business informs us,
    • “The Trump administration today released guidelines on renewed enforcement efforts under the Mental Health Parity and Addiction Equity Act (MHPAEA), after halting enforcement of the law in 2025.  
    • “The latest guidelines are not the administration’s revised parity law, but rather a framework for enforcement action and identifying red flags during the interim. 
    • “A Sept. 8 bulletin from the Assistant Secretary for the Department of Labor’s Employee Benefits Security Administration (EBSA), Daniel Aronowitz, describes the agency’s intent to more substantially enforce the parity law’s nonquantitative treatment limitation (NQTL) requirements, which resulted from collective industry feedback.” * * *
    • “The renewed enforcement focus will fall into three buckets, identified as areas of enforcement need in a 2025 report from the agency to Congress: treatment limitations and exclusions; standards for medical necessity and review and standards for determining network adequacy, admissions and provider reimbursement methodologies.” 
  • Beckers Hospital Review tells us,
    • “ACA insurers requested a median rate increase of 15% for 2027, according to a Peterson-KFF Health System Tracker analysis. However, [as explained in the article,] some states are pushing back — while others are abiding by those requests — as they finalize increases.”

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

  • FedScoop reports,
    • “The Office of Personnel Management is looking to prevent data on the federal government’s public job board, USAJobs, from making its way onto misleading websites. 
    • “Last week, OPM updated terms of service for users of its USAJobs application programming interface (API) to include prohibitions on several actions related to the sale or redistribution of data from the website “to third parties as a standalone product or feed.” 
    • “Data provided to you through the API is for the explicit use of the requesting company or individual identified on the USAJOBS Program Office API Registration Form. No other use of the data provided is permitted without prior approval, in writing, from OPM USAJOBS,” said an emailed notice sent to API users, including FedScoop. 
    • ‘While the reason for that change wasn’t initially clear, an OPM spokesperson told FedScoop via email Friday that the policy change is aimed at preventing “unauthorized services that appear to be USAJOBS or allow users to apply for federal jobs outside USAJOBS.” 
  • Federal News Network interviews Tammy Flanagan about questions that federal and postal employees may have about their FEHB and PSHB coverage as they turn 65 years old.

From the judicial front,

  • Beckers Payer Issues reports,
    • “Humana lodged a federal complaint Sept. 3 against Bayer AG and its acquired company, Monsanto, the business behind the weedkiller Roundup, seeking recoveries to address payments for Medicare Advantage members’ non-Hodgkin lymphoma-related care.
    • “Roundup’s active ingredient, glyphosate, has previously been linked to cancer risks. The lawsuit, filed in the U.S. District Court for the District of New Jersey, follows Monsanto’s proposed $7.25 billion settlement in February to resolve Roundup claims alleging non-Hodgkin lymphoma injuries. The settlement would act as a long-term compensation program, addressing current and future claims. Monsanto announced other settlement agreements in 2020, as well.
    • “However, Humana argues the February proposal does not confirm reimbursement for Medicare Advantage organizations that have already paid for relevant care. While the settlement acknowledges government payers, it establishes an “other insurers” category, including contracted payers. The complaint said this settlement lacks a “functional” lien-resolution program.”

From the fraud, waste, and abuse front,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “As part of the White House Anti-Fraud Task Force’s ongoing efforts to crush fraud in the healthcare system and protect taxpayer dollars, the Centers for Medicare & Medicaid Services (CMS) has identified and is barring 11 medical supply companies with more than $3.4 billion in suspected fraudulent billing practices in 2025 and 2026 from receiving future Medicare Advantage (MA) Part C and Part D payments. These 11 durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers, (1) had submitted no claims prior to 2025; (2) used improper billing practices for their claims; (3) had billed for medical equipment to beneficiaries already deceased; and (4) supplied equipment to beneficiaries who never requested or received it. Four of the suppliers had already been revoked from Original Medicare and began billing Medicare Advantage plans instead.” 

From the public health and medical / Rx research front,

  • Beckers Hospital Review reports,
    • “Albuquerque, N.M.-based Presbyterian Hospital said it found Legionella pneumophila in limited areas of the water system, including two rooms, Fox affiliate KRQE reported Sept. 7.
    • “The hospital implemented testing for the bacteria after a patient who recently received care at the hospital tested positive for Legionnaires’ disease. However, officials with the New Mexico Department of Health told CBS affiliate KOAT there is no definitive evidence showing the patient contracted the bacteria from Presbyterian. No additional cases have been identified and there is no known exposure to other patients or staff.
    • “The hospital received the environmental testing results Sept. 3 and immediately implemented safety precautions in affected areas.”
  • MedPage Today relates,
    • “Nicotine was long thought to fuel the inverse relationship between smoking and Parkinson’s disease.
    • “In this study, nonsmokers with high carbon monoxide (CO) levels had less Parkinson’s risk, suggesting CO may underlie smoking’s neuroprotective effects.
    • “The study followed more than 500,000 people for 12 years, measuring exhaled CO at baseline.”
  • and
    • “In a study of perimenopausal and recently postmenopausal women with vasomotor symptoms, initiation of menopausal hormone therapy (MHT) was associated with a 22% reduction in cardiovascular events.
    • “Notably, benefits were observed in those who initiated hormone therapy within 10 years of menopause onset and in Black women.
    • “The authors cautioned that given the lack of consistent cardiovascular benefit and the overall risk-benefit balance, the findings shouldn’t be used to support the use of MHT for cardiovascular prevention.”
  • Healio adds,
    • “Menopause remains inconsistently documented in electronic health records, according to a new systematic review published in Menopause.
    • “We expected to find some variation in how menopause was documented, but the extent of the inconsistency was striking,” Robin R. Austin, PhD, DNP, DC, MSN, RN, NI-BC, FAMIA, FAAN, an associate professor at the University of Minnesota School of Nursing, told Healio. “Menopause status and symptoms were often identified indirectly or incompletely, making it difficult to understand where a woman is in the menopause transition.”
  • Reuters tells us,
    • “Prescriptions for GLP-1 weight-loss drugs among children under 12 in the U.S. have risen more than 300-fold since 2019 as doctors seek new, effective ​treatments for younger patients with obesity, according to a study published on ‌Friday.
    • “The study, which included more than 3.5 million children aged between eight and 11 years with obesity but not diabetes, found that prescriptions for GLP-1 weight-loss drugs rose from 0.03% in ​2019 to 9.3% as of June.” * * *
    • “Although the drugs are not approved ​for use in children under 12 years, clinical guidelines allow the ⁠medications to be used for obesity in children as young as eight years ​old in certain cases.
    • “94% of the children prescribed GLP-1s had severe obesity, and ​about 65% had at least one related condition, such as high cholesterol, high blood pressure, and sleep apnea.” * * *
    • “While the absolute numbers of ​children under 12 receiving GLP-1 treatment is still low, the study shows that GLP-1 use ‌is ⁠accelerating rapidly, said lead investigator and obesity medicine specialist Dr. Babak Orandi of NYU Langone Health.”
  • Fierce Pharma adds,
    • Novo Nordisk has reported a phase 3 weight-management win for Wegovy in children, with two out of five kids no longer classified as having obesity after receiving the GLP-1 drug for 68 weeks.
    • Wegovy, the brand name for semaglutide in indications including obesity, is FDA approved for reducing body weight in people aged 12 years and older. Yet Wegovy and other GLP-1 drugs are increasingly used off-label in younger children, with a recent study finding that prescriptions in kids aged 8 to 11 jumped from 0.03% in 2019 to 9.3% in 2026.
    • Novo’s Step Young phase 3 trial suggests the younger children may benefit from Wegovy. Participants received weekly Wegovy injections of either 1.7 mg or 2.4 mg, based on their weight at the start of the trial, or placebo. All participants were assigned a reduced-calorie diet and increased physical activity.
  • STAT News informs us,
    • “In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday. 
    • “Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that “tozo,” as the injectable drug is dubbed, could reap billions in annual sales if approved, both in COPD — which, as the third-leading cause of death globally, remains greatly underserved — and in other conditions including asthma.” 
  • BioPharma Dive adds,
    • “Roivant said Tuesday a would-be treatment for a particular kind of high blood pressure associated with lung inflammation met all of its main and secondary objectives in a Phase 2 trial. Roivant’s medication, “mosliciguat,” reduced by 56% a measure of how difficult it is for blood to flow through the lungs of people with pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Roivant claimed that result was the “highest ever reported” in a randomized pulmonary hypertension trial and has already begun a Phase 3 study. The “exceptional” results, along with plans to develop mosliciguat in other conditions, could yield a drug with more than $10 billion in yearly sales, wrote Leerink Partners analyst David Risinger. Roivant shares surged 20%.”
  • and
    • “A new kind of cancer cell therapy from Bristol Myers Squibb has come through in a mid-stage trial, the company announced Tuesday. Dubbed arlocabtagene autoleucel or arlo-cel, the therapy is a CAR-T treatment directed at GPRC5D, a cell surface protein that’s overexpressed on diseased cells in multiple myeloma. Bristol Myers didn’t provide specific details. But it said arlo-cel demonstrated a “statistically significant and clinically meaningful” response rate in people whose multiple myeloma had progressed following at least four treatment lines — among them drugs aimed at BCMA, a more established multiple myeloma target.”
  • Fierce Pharma notes,
    • “In further validation of the DLL3 target pioneered by Amgen’s Imdelltra, the T-cell engager has delivered an overall survival win in first-line small cell lung cancer (SCLC).
    • “Imdelltra, used together with AstraZeneca’s Imfinzi, led to a “statistically significant and clinically meaningful” improvement in overall survival (OS) compared with Imfinzi alone as a first-line maintenance treatment for extensive stage SCLC, Amgen announced Tuesday.
    • “The Imdelltra regimen also showed superior progression-free survival and objective response rate, with safety consistent with the drugs’ known profiles, the company added.”
  • Genetic Engineering and BioTechnology News lets us know,
    • “Although the highly contagious bacterium Clostridioides difficile (C. diff) causes severe disease in adults, it has been reported to not cause symptoms in infants. Based on that, the assumption has been that infant colonization was not a serious health issue. That said, the consequences of early-life colonization on host development remain unknown. Now, in a new study, researchers at Children’s Hospital of Philadelphia (CHOP) are challenging that long-held assumption, with new findings suggesting that the bacterium can reshape the developing infant gut and may have long-term consequences.
    • “This work was published in Science in the paper, “Early-life colonization with Clostridioides difficile remodels the developing gut.”
  • The New York Times points out,
    • “Last year, a clinical trial conducted by Insilico Medicine, a company that aims to accelerate drug discovery using artificial intelligence, indicated that one of its drug candidates could help treat patients suffering from a chronic lung disease.
    • “Now, the company says that data from the same clinical trial shows a more intriguing possibility: that the drug could also slow the aging process.
    • “The molecular structure of the drug, called rentosertib, was generated with the assistance of A.I. Results of the new study, published Monday in the journal Nature Biotechnology, show that the drug reduced the biological markers of age as measured by six “aging clocks,” a different kind of A.I. technology designed to predict a person’s morbidity and mortality.
    • ‘This elaborate clinical trial is a milestone in the widespread effort to improve health care using the same A.I. techniques that underpin popular chatbots like ChatGPT and image generators like Midjourney. Insilico is just one of many start-ups, tech giants and academic labs working to accelerate drug discovery and honeother medical tasks with help from these methods.”
  • and
    • “It is one of biology’s most ingenious rhythms: Every baby is born young. No matter how much wear and tear their parents’ DNA accumulated over their lifetimes, reproduction erases the molecular scars, handing a clean slate to the next generation.
    • “Now, a new frontier in biotechnology aims to harness this natural mechanism to do something once thought impossible: scrub away the biological detritus of our own past. By mimicking Mother Nature’s magic eraser, geneticists are working to open a new avenue for treating or preventing disease later in life — not by editing genes themselves, but by altering when, where and how genes are expressed.
    • “All of this is possible thanks to the epigenome, a network of chemical tags throughout the body that latch on to DNA and tell each cell type how to behave. If a person’s DNA is a string of notes in a musical score, the epigenome is the collection of the conductor’s pencil markings left on the page — accumulated through experience over time, indicating which notes to play louder or softer or to skip entirely.”

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

  • Beckers Payer Issues reports,
    • “Growth in healthcare spending, not insurer profit margins, drove the vast majority of commercial premium increases over more than a decade, according to a study published Sept. 4 in JAMA Health Forum.
    • “Researchers at Yale University and the University of Wisconsin-Madison analyzed CMS data from 2011 to 2024 covering the large group, small group and individual markets, which included information on premiums, health spending and insurer markups for each state and year. The data did not include self-insured employers, which cover roughly half the U.S. population.”
  • Fierce Healthcare relates,
    • “After a failed round of in vitro fertilization this year, Anne Hug’s fertility doctor said she had a single polyp in her uterus that should be removed to improve the chance of pregnancy. Hug, a professor of radiology, learned that the American College of Obstetricians and Gynecologists says the procedure can be done in a doctor’s office with local numbing.
    • “Her doctor referred her to a physician at the same hospital, which is part of a large Ohio health system. That doctor’s plan was to do the procedure in a hospital operating room, with anesthesia administered by an anesthesiologist.
    • “Hug balked at the $18,000 estimate.
    • “The estimate for the in-office procedure was around $3,000. The bill when she was forced at the last minute to switch to the surgery center was around $6,000. She now wonders, “How is it legal for these hospitals to force patients to have procedures done in a hospital when professional organizations recommend differently?”
    • “Hug’s experience is a classic example of the predicted outcome of “vertical integration” in the healthcare system, when one company owns or controls multiple parts of a supply chain and can therefore direct patients to more expensive treatment options.”
  • Beckers ASC Review tells us,
    • “Twenty-seven states [listed in the article] have opted out of the federal requirement that a physician supervise CRNAs administering anesthesia, according to the American Association of Nurse Anesthesiology’s most recent fact sheet, updated in July 2026.
    • “Vermont and Ohio became the 26th and 27th states to opt out, making the move in July 2026. The full list stretches back more than two decades, and for ASC leaders dealing with anesthesia staffing costs, where a state falls on that list is directly relevant to how much flexibility they have to restructure anesthesia coverage.” * * *
    • “In opt-out states — provided state law and facility policy also allow it — ASCs have more room to build CRNA-based staffing model models. Seattle-based Proliance Surgeons moved to a CRNA-only staffing model in 2025 after the anesthesiology group it was partnered with decided not to renew its contract. After switching the new model, the organization reported no patient care delays and no cases redirected to hospitals over provider-availability concerns.
    • ‘That’s just one case study, but as more states move away from the federal supervision requirement, the staffing-model conversation for ASCs is likely to keep shifting from “how much do we pay for anesthesiologist coverage” to “do we need anesthesiologist coverage for this case mix at all.”
  • The American Hospital Association News notes,
    • “A report on obstetric services in hospitals by the University of Minnesota Rural Health Research Center found that between 2010 and 2024, 718 hospitals nationwide lost obstetric services due to obstetric unit or hospital closure. The report found that 9% of those losses happened from 2023-2024. Between 2010-2024, 14% of hospitals (16% of rural hospitals, 13% of urban hospitals) lost obstetric services, while 35% (42% rural, 30% urban) never had obstetric services during that period. By 2024, 57.5% of rural hospitals and 43.6% of urban hospitals across the U.S. were without obstetric services.” 
  • Healthcare IT News explains how “telemedicine becomes more deeply embedded into hospital workflows.”
    • “Health systems are using virtual nursing, tele-ICU, remote specialty care and EHR-integrated teams to extend scarce expertise, support bedside clinicians and redesign care delivery.”
  • Beckers Physician Leadership discusses the “uneven collapse of private medical practice.”
    • “While the decline of independent practice has persisted as a general trend across medicine, the consolidation of physician practices has played out differently across specialties. 
    • “A 2025 specialty-level breakdown of independent practice published by the American Medical Association found private-practice rates ranging from 70.4% in ophthalmology down to 30.7% in gastroenterology, a nearly 40-percentage-point gap between the most and least independent of the five specialties driving the bulk of physician practice mergers and acquisitions activity.”
  • Fierce Healthcare informs us,
    • “Oura, the smart ring maker and health tracking company, filed to go public on Thursday [September 10] to fuel its next phase of growth as it aims to build an artificial intelligence-powered health platform.
    • “The company has not specified the number of shares to be offered or the price range for the proposed offering. Oura intends to list on the Nasdaq under the ticker symbol “OURA.”
    • “Founded in Finland in 2013, Oura’s smart rings continuously track more than 50 health metrics, including heart rate, sleep, daily movement and activity, stress, fertility windows and metabolic health.”
  • and
    • “Five Kansas health systems have launched a regional collaboration, called Astra Health, to pool resources and coordinate services while retaining their independence. 
    • “The new shared services organization was announced Tuesday and will include LMH Health, The University of Kansas Health System, Amberwell Health, Newman Regional Health and Salina Regional Health Center. Together, the organizations see more than half a million patients annually and extend into every county in the state. 
    • “The partnership will help participating hospitals improve quality, share best practices, enhance performance measurement, and strengthen care delivery in the communities they serve,” Shelly Kortkamp, M.D., president and CEO of LMH Health, said in an announcement.”
  • and
    • “Health tech startup Forus banked $150 million in series C funding as it aims to expand its artificial intelligence-powered network to more medical specialties and care settings.
    • “The fresh funding comes just four months after the company announced it raised $160 million in a series B round. The latest funding round boosts Forus’ valuation to $3 billion, tripling from its series B round in May, according to the company. Forus has raised more than $300 million to date.
    • “Bain Capital Ventures, an investor in Forus since its seed round, led the latest round, with every existing institutional investor reinvesting, including Thrive Capital, General Catalyst, Accel, Redpoint, BoxGroup, Pear VC, Vast Ventures and SV Angel.”
  • Per BioPharma Dive,
    • “BrainChild Bio, a cell therapy developer making CAR-T treatments for children with rare brain cancers, has banked $116 million in a round of venture financing, the company announced Tuesday.
    • “CAR-T therapies are powerful treatments engineered from immune cells. A handful have been approved to treat certain blood cancers, and many companies are studying their potential on other tumors and even autoimmune diseases.
    • “But according to BrainChild founder and Chief Scientific Officer Michael Jensen, few companies have tried to test CAR-T treatments against brain cancer. “The prejudice is that the brain would be intolerant to having cells directly administered,” he said. 
    • “BrainChild is different. Spun out of research at Seattle Children’s Hospital three years ago, the company is working on a pair of brain cancer cell therapies designed specifically for children.”
  • Per Fierce Pharma,
    • “Spying a “golden decade” beyond the branded drug industry’s looming patent cliff, Sandoz is making big bets on its biosimilar capabilities in the coming years. 
    • “Under the company’s so-called Bio100 plan, Sandoz is setting the ambitious goal to establish a portfolio of more than 100 biosimilars by 2040, up substantially from the 13 it currently markets. Meanwhile, the company also aims to expand the overall biosimilar loss of exclusivity (LOE)-value it holds from some 50% today to around 80% from 2035 onwards.
    • “Part and parcel to that, Sandoz hopes to double its net sales from 2025 through the middle of the next decade, according to a Sept. 8 release outlining the strategy. For all of last year, the Swiss drugmaker reported 5% net sales growth at constant currencies to $11.1 billion.” 
  • Tech Target offers “6 use cases for improving employee retention using predictive analytics.”
    • Predictive analytics can identify employees who are good candidates for promotion. Learn other use cases for improving employee retention using predictive analytics.

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.”

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.”

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.”

Tuesday report

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

Simplicity is a virtue

From Washington, DC

  • Beckers Hospital Review reports,
    • “CMS awarded Alaska $160 million through the Rural Health Transformation Program, funding 142 projects to expand access to rural healthcare statewide.
    • “The funding package includes $6.5 million to bring the first robotic-assisted minimally invasive surgery program to Southern Southeast Alaska, $5 million to build a tribally led residential treatment and recovery campus in Southeast Alaska, and more than $3.1 million to deploy AI-powered medical imaging across 21 acute care hospitals for faster stroke detection.
    • “Alaska will also use $250,000 to develop a drone-based pharmaceutical delivery system for villages spread across 94,000 square miles, where medication deliveries can take five to 14 days during winter months. Nearly $4.6 million will strengthen the Alaska Family Medicine Residency Program, and $4.75 million will expand health information exchange connectivity for rural providers.”
  • Beckers Payer Issues relates,
    • “Nine months after President Donald Trump announced a deal offering states discounted pricing on GLP-1 drugs for Medicaid patients, most states are declining to participate, according to an Aug. 22 Politico report.
    • “Only Indiana has publicly signed on, while 29 state Medicaid programs have said they will not participate and 14 more did not respond to requests for comment, according to the report. CMS also declined to provide a list of participating states.” * * *
    • “Medicaid spending on GLP-1s grew from $1 billion in 2019 to almost $9 billion in 2024, and nearly 40% of patients with obesity could qualify for coverage if states opted in, according to the report. States that do not cover the drugs can still direct Medicaid enrollees to purchase them out of pocket through TrumpRx. The platform lists injectable Wegovy and Ozempic at average prices of about $350 a month, down from more than $1,000, though some pricing comparisons have found many listed drugs are available for less through existing Medicare Part D or Medicaid discounts. Even at the discounted rates, the drugs may remain unaffordable for many low-income patients.”
  • Beckers ASC Review tells us,
    • “The Federal Trade Commission has finalized a consent order requiring Ascension Health Alliance to divest seven Amsurg ASCs across five markets as a condition of its $3.9 billion acquisition of Amsurg, which closed in early June, according to an Aug. 25 news release from the FTC.
    • “The seven centers span Nashville, Panama City, Fla., Tulsa, Okla., Waco, Texas and Wichita, Kan. Six will be divested to Optum’s SC Affiliates, while the Panama City center will go to Florida Gastroenterology Center. The FTC alleged the acquisition would limit competition for outpatient surgical services performed by gastroenterologists, ophthalmologists and orthopedists in those markets, potentially leading to higher prices and lower quality of care. 
    • “The final order also requires Ascension to provide prior notice to the FTC before acquiring any additional ASCs in the metro areas around the divested centers. The Commission voted 2-0 to approve the final order.
    • “The deal, which expanded Ascension’s ASC footprint from 58 to more than 300 centers across 34 states, gives the St. Louis-based health system one of the largest ASC networks in the country.” 
  • SHRM informs us,
    • “The U.S. Department of Labor (DOL) has finalized three rules dismantling or scaling back longstanding affirmative action requirements for federal contractors, completing a major piece of the White House’s effort to reshape federal equal employment opportunity enforcement.
    • “Published in the Federal Register Aug. 21, the rules address three pillars of the regulatory framework administered by DOL’s Office of Federal Contract Compliance Programs (OFCCP): Executive Order 11246, Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA).” * * *
    • “For contractors, the result is a substantially different compliance landscape — one with fewer federally mandated affirmative action metrics and data-collection requirements. However, there remain continuing obligations to prevent unlawful discrimination and, in the disability and protected-veteran contexts, enduring statutory affirmative action duties.”

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

  • OPM published in today’s Federal Register the following final rule corrections:
    • Improving Performance, Accountability and Responsiveness in the Civil Service, and Recruitment and Relocation Incentive Waivers; Correcting Amendments FR Document:2026-17334 Citation: 91 FR 54796 PDF Pages 54796-54797 (2 pages) Permalink
    • Reduction in Force Appeals; Correction FR Document:2026-17338 Citation:91 FR 54796 PDF Page 54796 (1 page) Permalink
    • Reduction in Force; Correction FR Document:2026-17335 Citation:91 FR 54794 PDF Pages 54794-54796 (3 pages) Permalink
    • Streamlining Probationary and Trial Period Appeals; Correction and Technical Amendment FR Document:2026-17336 Citation: 91 FR 54793 PDF Pages 54793-54794 (2 pages) Permalink
    • Suitability Action Appeals; Correction. FR Document:2026-17337 Citation:91 FR 54798 PDF Page 54798 (1 page) Permalink
  • OPM Director Scott Kupor added another post to this Secrets of OPM blog (Substack link).
    • “This week, the Partnership for Public Service published an analysis claiming that agencies paid employees to leave through the Deferred Resignation Program (DRP) and then quietly hired their replacements. This is a claim that has surfaced frequently in the media in the past year: that the DRP reductions were not real because of backfills.
    • “The Partnership’s own analysis, however, confirms that these claims have no merit.
    • “According to OPM’s workforce data, 139,928 employees participated in the DRP. The Partnership identifies 20,557 subsequent hires that it considers “backfills.” Even accepting that figure at face value – the Partnership is using broad job classifications that can often encompass hundreds of actual jobs as a very imperfect proxy that likely significantly overstates actual backfills – it amounts to 14.7 percent of DRP participants.
    • Thus, more than 85 percent of employees who took the program are not matched to any subsequent hire. That’s pretty good for a program that was rolled out government-wide. Simply put, 85% of the reductions were real and lasting.”

From the Food and Drug Administration front,

  • Reuters reports.
    • “The U.S. Department of Health and Human Services is planning to appoint two new deputy commissioners at the Food and Drug ​Administration, CNBC reported, citing sources familiar with the ‌matter.
    • “One role would focus on technology, including healthcare and AI, while the other would oversee drugs, according to two people familiar with the plans.”
  • Per Fierce Pharma,
    • “Jazz Pharmaceuticals’ bispecific antibody Ziihera has gained FDA approval for first-line HER2-positive stomach cancer, unlocking another market as the company builds toward a $2 billion-plus peak sales target. 
    • “The latest green light allows Ziihera to be used in addition to chemotherapy, with or without BeOne Medicines’ Tevimbra, in previously untreated, HER2-positive advanced gastroesophageal adenocarcinoma (GEA). 
    • ‘The approval permits Jazz to challenge more than a decade of practice, in which trastuzumab (Herceptin) has been the standard HER2 agent used alongside platinum-based chemotherapy—with or without a PD-1 inhibitor—as first-line therapy for these stomach cancer patients.” 
  • The Hill tells us.
    • “Vitruvias Therapeutics is voluntarily recalling one lot of thyroid tablets because they could potentially be “superpotent,” federal regulators announced this week.
    • “The high potency 30mg tablets could cause hyperthyroidism, or an overactive thyroid, according to the Food and Drug Administration. The affected lot (504950) was distributed nationwide to Vitruvias Therapeutics’ direct accounts from Jan. 31 to Sept. 30, 2025.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The Libre Duo 10 Day is the first wearable device in the U.S. that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar (glucose) together in a single device.
    • “Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency.”
    • “According to the Centers for Disease Control and Prevention, an estimated 40.1 million Americans are living with diabetes, a condition that requires careful monitoring of blood sugar levels. For the estimated 2.1 million Americans with type 1 diabetes, blood sugar is only part of the picture. When the body produces too much ketone, which is made by the body when it is using fat instead of glucose for energy, it can lead to diabetic ketoacidosis, or DKA — a serious complication that can develop quickly and become life-threatening if left untreated.”
  • Beckers Hospital Review points out,
    • “The FDA cleared Amygdala Neurosciences’ Investigational New Drug application for ANS-858, allowing the company to move the drug into clinical development.
    • “ANS-858 is a selective, reversible, orally bioavailable inhibitor of aldehyde dehydrogenase 2 (ALDH2), according to an Aug. 18 news release from the company. It plans to begin a phase 1 clinical trial, which is designed to support later evaluation of ANS-858 across multiple indications in phase 2 clinical trials.
    • “Amygdala Neurosciences is initially advancing ANS-858 as a potential treatment for alcohol use disorder and other substance use disorders. It is also evaluating the drug in compulsive eating disorders associated with binge eating and obesity.”
  •  Cardiovascular Business informs us,
    • “Young M. Lee, MD, a cerebrovascular surgeon with University Medical Center New Orleans, was the first U.S. physician to perform a stroke thrombectomy with Thunderbolt, a computer-assisted vacuum thrombectomy (CAVT) system from Penumbra that gained U.S. Food and Drug Administration (FDA) clearance back in June. 
    • “Lee performed the procedure on a young male patient who presented with a right middle cerebral artery (MCA) syndrome and a right M1 occlusion. He spoke to Cardiovascular Business about the experience, noting that this first patient was an especially challenging case due to preexisting intracranial atherosclerotic disease.
    • “I was able to observe the Thunderbolt essentially detect the clot and completely aspirate the clot starting from its proximal end in the mid-M1 segment all the way up to the point of the MCA bifurcation,” he explained. “With the fluoroscopy running, I could see the aspiration catheter advance towards the MCA bifurcation as the pump responded to what was happening, which is not something you see with a traditional non-modulated aspiration technique.”

From the judicial front,

  • Federal News Network reports,
    • “The Trump administration is facing a new lawsuit from federal unions after it issued a pair of recent final rules overhauling federal employee suitability standards and performance evaluations.
    • “Filed on Monday in the U.S. District Court for the Northern District of California, the unions’ lawsuit contends that the Office of Personnel Management exceeded statutory authority and violated the intent of the Civil Service Reform Act when it issued regulations to change suitability and fitness regulations and reshape the performance management system for the federal workforce.
    • “Taken together, the changes will make it easier for OPM and agencies to fire federal employees, while limiting opportunity for employees to challenge their removals or other adverse actions, the unions argued. Their lawsuit is the latest of several legal challenges unions are taking against the Trump administration’s efforts to revise federal workforce policies and regulations.
    • “The American Federation of Government Employees is leading the lawsuit, with other plaintiffs including the National Federation of Federal Employees (NFFE), the International Federation of Professional and Technical Engineers (IFPTE) and the American Federation of State, County and Municipal Employees (AFSCME).”
  • Per a Justice Department news release,
    • “The Department of Justice today announced the emergency scheduling of three highly potent opioid compounds that pose an imminent hazard to public safety: mitragynine pseudoindoxyl, commonly known as MGPI, and two synthetic compounds known as MGM-15 and MGM-16.
    • “The Justice Department is acting before these dangerous compounds become a broader threat,” said Attorney General Todd Blanche. “These are potent opioids being manufactured and sold in consumer products, often under labels that obscure their true risks. This action will protect our nation’s children and communities from the dangers of drug addiction and abuse.”
    • “The Drug Enforcement Administration is temporarily placing the three 7-hydroxymitragynine-related substances in schedule I of the Controlled Substances Act. Preclinical evidence indicates that all three are potent mu-opioid receptor agonists and may present risks associated with other mu-opioid agonists, including dependence and respiratory depression. MGPI and MGM-15 are manufactured and marketed in products sold for their opioid effects. MGM-16 has not been confirmed in the consumer market but is a highly potent compound that could emerge as a substitute for related substances.”
  • The New York Times adds,
    • “Since the early 2000s, the number of fatal overdoses in the United States has soared. And the rate in Baltimore — 110 deaths per 100,000 residents, according to a recent analysis by the San Francisco Chronicle — is the highest among cities with a populations of a half-million or more.
    • “The initial cause was prescription opioids, then heroin, and then, starting a decade ago, a new generation of synthetic opioids, mainly fentanyl. Now, new combinations of ultrapotent lab-made drugs reach the street almost daily, making the narcotics supply — in Baltimore and beyond — more dangerous, polluted and unpredictable than it has ever been.” * * *
    • “Because lab-made drugs are so easily mixed and altered, their effect is uncertain; few buyers know what they’re actually getting, and the possibilities are expanding dangerously. Last summer, several mass overdoses in Baltimore resulted when fentanyl was mixed with N-methylclonazepam, a powerful sedative. Across the country, 22 percent of drug samples contained five or more compounds, an increase from 8.8 percent in 2022, according to testing done by the National Institutes for Science and Technology.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Two unvaccinated people in Pennsylvania have died after contracting measles, the state health department said, the U.S.’s first measles-associated deaths reported this year.
    • “Both of the people lived in Lancaster County, a populous area in the southeast part of the state known for its large Amish community, the health department said Tuesday. The deaths mark Pennsylvania’s first measles-related fatalities in 35 years and are part of a larger outbreak in the state. 
    • “Pennsylvania has confirmed more than 390 cases of measles across 28 counties so far this year, all in people who weren’t fully vaccinated. Nearly half have come from Lancaster County. About a third of the Pennsylvanians affected are under 18 years old.
    • “I want to be clear: This illness and death from measles is completely preventable,” said Pennsylvania Gov. Josh Shapiro. “We already have the tools to protect ourselves and our families from this disease, which is one of the most contagious diseases on the face of the earth.”
  • The National Institutes of Health’s Research Matters covers the following topics in its latest issue.
    • “Dementia-free years may decrease with smoking, hypertension, and diabetes.
      • “Researchers found that smoking, high blood pressure, and diabetes in midlife lower the number of years a person is likely to live without dementia.
      • “The findings could help guide behavior and lifestyle changes to prevent dementia.
    • “Coating stops tooth decay in children.”
      • “A clinical trial found that a topical treatment called silver diamine fluoride stops cavities in young children from getting worse.
      • “The simple treatment could prevent surgery and other serious consequences for children with severe tooth decay.”
    • “DNA organization changes in Alzheimer’s disease, aging.”
      • “New research showed the 3D organization of DNA in cells changes in Alzheimer’s disease and aging.
      • “The results suggest the changes may contribute to altered gene activity observed in Alzheimer’s and aging.”
  • Health Day relates,
    • “A combo of hormone therapy and targeted drugs appears to help patients with metastatic breast cancer
    • “About 97% of patients benefited during the first six months
    • “The treatment, mainly using pills and under-the-skin injections, could eventually offer some patients an easier first-line option.”
  • and
    • “Hoping for a quick response from your doctor to a message sent through your patient portal?
    • “Then keep it cordial and positive, a new study suggests.
    • “Doctors were more likely to respond to messages that addressed them by name and had a positive tone, researchers reported Aug. 24 in JAMA Network Open.”
  • Beckers Hospital Review lets us know,
    • “Pediatric medications have more active FDA-listed shortages than any other therapeutic category, according to the FDA’s drug shortage database.
    • “Here are the categories with the most active shortage listings, ranked by number of active shortages as of Aug. 25:
      • 1. Pediatric: 18
      • 2. Anesthesia: 10 (tie)
      • 2. Cardiovascular: 10 (tie)
      • 3. Analgesia/addiction: 9 (tie)
      • 3. Gastroenterology: 9 (tie)
      • 4. Endocrinology/metabolism: 8 (tie)
      • 4. Neurology: 8 (tie)
      • 5. Anti-infective: 7 (tie)
      • 5. Oncology: 7 (tie)
      • 5. Psychiatry: 7 (tie)

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

  • Beckers Payer Issues reports,
    • “Most large health insurers posted stronger-than-expected earnings in the second quarter, but much of the improvement might not be durable, according to a Moody’s Ratings analysis published Aug. 24.
    • “Average EBITDA margins across the seven largest publicly traded insurers rose to 4.7% in Q2, up from 3.9% in the same period a year earlier. UnitedHealth Group posted the largest swing, expanding to 6.2% from 3.7%, while Centene jumped to 3.7% from 0.6% on the back of marketplace margin recovery and outperformance in its Medicare Advantage and prescription drug plan businesses. Five of the six insurers that reported results raised or affirmed full-year guidance.
    • “The rating agency cited high-cost specialty drugs, sustained behavioral health demand and aggressive provider billing and coding as ongoing pressures. The report also described a “clear industry pivot toward margin stabilization rather than top-line growth,” calling the shift broadly credit positive.”
  • Beckers ASC Review adds,
    • “For nearly as long as health insurers have used prior authorization to control costs, physicians and hospitals have argued it does more harm than good. 
    • “The pushback against prior authorization has reached new heights in recent months as healthcare leadership, legislators and physician advocacy organizations have proposed major reforms or outright bans of the practice.” 
  • Healthcare Dive relates,
    • “Name: Dr. Patrick Fox
    • “Previous title: President, Wellpoint New Jersey
    • “New title: President, Carelon Behavioral Health
    • “Fox is assuming the top role at Elevance’s behavioral health division effective immediately, the Indianapolis-based insurer announced Monday.”
  • Beckers Hospital Review tells us,
    • “New York City-based NewYork-Presbyterian reported operating income of $124.2 million (4% operating margin) during the second quarter of 2026, up from $101.7 million (3.6% margin) during the same period last year, according to its Aug. 24 disclosure report.”
  • and
    • “Orlando (Fla.) Health recorded operating income of $81.5 million (3.0% operating margin) in the third quarter of fiscal 2026, up from $56.3 million (2.2% margin) during the same period last year, according to its Aug. 25 finance report.”
  • and
    • “As health systems continue to grapple with financial pressures from rising labor and supply costs and reimbursement challenges, days cash on hand remains an important measure of financial stability. 
    • “[The article shares} days cash on hand figures for 25 health systems as of June 30, according to their most recent financial reports”
  • Fierce Healthcare tells us,
    • “The Oregon Health Authority (OHA) approved a deal on Monday that would merge the nonprofits MultiCare Health System and Samaritan Health Services.
    • “State regulators said the OHA’s Health Care Market Oversight (HCMO) program reviewed how the proposed merger would affect Samaritan’s facilities and its impact on Oregon citizens’ access to affordable and equitable healthcare. 
    • “HCMO approved the deal provided it meets established conditions (PDF), including requiring MultiCare to follow its financial commitment of investing $700 million towards Samaritan and posting a public-facing version of the commitment on Samaritan’s website. Other conditions involve reinvestment of Samaritan’s operating margins into local communities and a requirement to maintain existing services.”
  • and
    • “Artificial intelligence-driven specialty care navigation platform Switchboard Health announced Tuesday the acquisition of virtual orthopedics and musculoskeletal (MSK) management provider Livara Health.
    • “Switchboard Health will embed Livara’s MSK program in its automation platform for referral management and care navigation, through the acquisition, to enable providers and health plans to enroll patients.
    • “Financial details of the transaction were not disclosed.”
  • Beckers Physician Leadership informs us,
    • More than half of active U.S. physicians worked for hospital systems as of 2024, up from 20% in 2010, and hospital systems have acquired more than 20,000 physician practices since 2015, according to a recent study published in JAMA Network Open.
    • Becker’s ASC Review tracked more than 50 physician practice deals in 2026 — with consolidation taking over some areas of medicine more than others. 
    • [The article provides] a breakdown by across five specialties.

Notable Death

  • The Wall Street Journal reports,
    • “One night in 1973, Dolly Parton had a song on her mind. She was thinking about a bank teller who had been flirting with her spouse.
    • “She got this terrible crush on my husband,” Parton told NPR in 2008. “And he just loved going to the bank because she paid him so much attention.”
    • “Needing a name for this tall, redheaded temptress, she thought of another flame-haired girl, an 8-year-old who approached her for an autograph after a taping of “The Porter Wagoner Show,” the TV series on which she was featured. That child’s name was Jolene.
    • “Parton died Tuesday at age 80 in Nashville, Tenn., according to her family. The cause of death wasn’t released. In May, Parton canceled a Las Vegas residency because of health issues.”
  • Beckers Hospital Review adds,
    • “Beyond her music and film career, Ms. Parton spent decades directing philanthropic dollars toward hospitals and medical research, much of it concentrated in her native East Tennessee and at Nashville-based Vanderbilt Health. [The article shares] seven ways her giving left an imprint on healthcare.

Monday report

David Ermer–Agentic & Generative AI, CMS, Federal employment benefits, Medicare, OPM, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $144 million investment is being delivered to improve health outcomes for Alabamians through the federal Rural Health Transformation Program (RHTP) This investment will support 138 grants to expand access to care, modernize healthcare technology and infrastructure and strengthen the rural healthcare workforce.
    • “This funding will help rural providers modernize their technology and cybersecurity, enhance telehealth and mobile care services, strengthen emergency and maternal care, and improve access to mental health and substance use care. The Trump Administration is also investing in expanding the healthcare workforce through training, scholarships, apprenticeships, and recruitment efforts, while helping local providers strengthen community-based care and better coordinate services. These investments will help make healthcare more accessible, connected, secure and sustainable across Alabama regardless of your zip code.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. and Secretary of Agriculture Brooke L. Rollins today announced sweeping new efforts to strengthen school meals by connecting more American farmers with local schools, investing in school kitchen infrastructure, and giving states and school districts new tools to serve healthier, more nutrient-dense meals to America’s children.
    • “Secretary Kennedy joined Secretary Rollins at the U.S. Department of Agriculture (USDA) alongside farmers, students, school nutrition leaders, athletes, chefs, and parents to announce the next phase of the Trump Administration’s work to Make America Healthy Again.” * * *
    • “If we want to Make America Healthy Again, we have to start with our children, and that means improving what we put on their lunch trays every single day,” said Secretary Brooke L. Rollins. “Harvest to Hallways is about bringing more American agriculture into the school cafeteria. We are connecting schools with the farmers and ranchers in their own communities, investing in the kitchens and equipment school nutrition professionals need to prepare real food, and cutting through barriers that have made it too difficult to serve healthy, American-grown food. When we strengthen the connection between the farm and the lunchroom, everybody wins: our children eat better, our farmers gain new markets, and our communities grow stronger.”
  • STAT News adds,
    • “New restrictions on the use of food benefits to purchase soda and candy have been one of the biggest changes enacted by the Make America Healthy Again movement. But a key question has been how profoundly the bans would affect public health, with some economists arguing that people would just use other funds to buy Coke and other sugary drinks instead.
    • “Now a new study shows that soda purchases did indeed fall by about 12% among people who receive Supplemental Nutritional Assistance Program benefits after the bans went into effect in 10 states. The study, which was published by the National Bureau of Economic Research and has not yet been peer-reviewed, says this translates to a person drinking about 34 fewer 12-ounce cans of soda per year.”
    • “That’s not huge, according to the study’s authors, but it’s far from nothing.”
  • Beckers Hospital Review reports,
    • “More than 200 healthcare organizations urged CMS not to finalize proposed limits on remote monitoring, warning the changes would disrupt care for about 1 million Medicare beneficiaries who manage chronic conditions from home.
    • “In a sign-on letter to CMS Administrator Mehmet Oz, MD, the coalition asked the agency to hold off on remote physiologic monitoring and remote therapeutic monitoring policies included in the 2027 Medicare Physician Fee Schedule proposed rule. More than 30 health systems and hospitals signed the letter. 
    • “The provision at issue, proposed July 14, would allow clinical practices to bill Medicare for the services only if the clinical staff delivering them are directly employed by the billing practice rather than contracted through a third-party vendor. Staff could still work off-site; the billing relationship would have to run in-house.
    • “That distinction carries broad reach. An estimated 60% to 70% of hospitals and health systems using remote monitoring rely on partially or fully outsourced vendor models, according to Becker’sprior reporting. The signers of the letter said small practices, rural providers and safety-net organizations would be hit hardest, and that many would have no option but to cut enrollment or end their programs.”

From the U.S. Office of Personnel Management front

  • FedWeek reports,
    • “President Trump has not yet sent Congress the alternative pay plan letter that will determine the 2027 federal pay raise, and the statutory deadline to do so arrives August 31. The letter is the clearest remaining signal of whether federal employees face a full pay freeze next year or another modest increase similar to the one delivered a year ago.
    • “Under the Federal Employees Pay Comparability Act (FEPCA) of 1990, the president must submit an alternative pay plan to Congress by the end of August, or a statutory formula tied to private-sector wage growth automatically takes effect instead, producing a far larger locality pay increase than any administration has allowed to take hold since the law passed. FedSmith has explained the mechanics of this deadline before, and last year’s letter covering the 2026 raise arrived on August 28, just three days before the cutoff. A similarly late announcement is likely again this year.”
  • and
    • Federal employees under the General Schedule receive a base salary plus a locality payment that varies by geographic area. The 2026 rates range from 17.06% in the Rest of U.S. locality pay area to 46.34% in the San Jose-San Francisco-Oakland, CA, locality pay area.
    • “The federal locality pay system adjusts General Schedule salaries to reflect differences in non-federal pay levels across geographic regions. Authorized by the Federal Employees Pay Comparability Act of 1990, the system took effect in January 1994. Its purpose is to reduce pay disparities between federal and non-federal workers performing similar work in the same labor market.
    • “Locality payments are calculated as a percentage of base pay and applied according to the employee’s official worksite. The Office of Personnel Management publishes annual tables that incorporate both the across-the-board base pay increase and the locality adjustment for each designated area. For 2026, locality pay percentages remain at the prior year’s levels, while base pay received a 1.0% across-the-board increase.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration cleared a blood test for identifying Alzheimer’s disease symptoms, which was developed by Roche and Eli Lilly.
    • “The Elecsys Phospho-Tau Plasma test identifies amyloid pathology associated with Alzheimer’s in people 55 years or older.
    • “It provides positive, intermediate and negative result categories to support doctors assessing the likelihood of amyloid pathology. Results are interpreted in conjunction with clinical information and other relevant findings as part of an Alzheimer’s diagnosis.
    • “The blood test is meant to address the gap in diagnoses, as an estimated 75% of people living with dementia are undiagnosed, Roche said.
    • “Quest Diagnostics and Labcorp both said they plan to start offering the blood test.”
  • MedTech Dive relates,
    • “The Food and Drug Administration has picked two behavioral health companies to join its Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, growing the total number of participants to four.
    • “Limbic and Sondermind are the next companies to join the pilot program, which allows participants to gather real-world data on devices while being exempted from premarket authorization requirements.
    • “Amid the pilot program, the FDA has also held discussions on digital health technologies for mental health, with patient groups calling for broader oversight in the use of generative artificial intelligence.”
  • Beckers Hospital Review tells us,
    • “The FDA has again paused Regenxbios RGX-121 gene therapy trial for Hunter syndrome after small, asymptomatic masses were found on the spines of five patients. Regenxbio does not expect to resubmit its biologics license application for the therapy in the near term.
    • “The spine findings, either a small nodule or cystic mass, surfaced through an expanded MRI monitoring plan Regenxbio adopted a few months ago, according to an Aug. 24 news release. All five patients received intracisternal or intraventricular RGX-121 three to six years ago, remain asymptomatic and have shown stability to improvement on neurocognitive assessments. Investigators consider the findings nonserious and likely benign, though no pathological evidence confirms their cause.
    • “The pause comes seven months after Regenxbio disclosed that a boy who received its similar MPS I therapy, RGX-111, developed a brain tumor, a case researchers have since linked to AAV gene therapy, the vector platform used in most gene therapies over the past 20 years.”

From the judicial front,

  • Fierce Pharma reports,
    • “On Monday, the U.S. District Court for the District of Columbia ruled against Merck & Co., rejecting its claim that the price negotiations are unconstitutional because they violate the First and Fifth Amendments. The argument is one that has been made by multiple drugmakers pushing back against the program.” 
  • Per a Justice Department news release,
    • “Today, the U.S. Department of Justice announced the launch of the National Fraud Detection Center (NFDC), a prosecutor-led, multi-agency team designed to investigate the most harmful actors defrauding federal government programs, including illicit actors overseas and those operating fraud schemes across federal programs. The NFDC will bring together law enforcement agencies and analytical capabilities to generate criminal leads to drive more impactful prosecutions and enhance fraud-fighting results for the American people.
    • “The creation of the NFDC marks a decisive shift in how the federal government detects and investigates complex fraud,” said Assistant Attorney General Colin McDonald of the Justice Department’s National Fraud Enforcement Division. “By breaking down institutional silos, embedding analysts from across the IG community, and leveraging shared technology, the NFDC is actively closing the window of opportunity for bad actors who seek to exploit taxpayer dollars. Today’s announcement sends a clear message: if you defraud federal programs, we have the tools and the law enforcement partners to find you.”

From the public health and medical / Rx research front,

  • Beckers Hospital Review reports,
    • “A fast-moving wildfire in the Sierra Nevada foothills has forced two Northern Nevada Health System facilities in the Reno, Nev., area to evacuate patients and close, according to CBS News and The New York Times.
    • “Both facilities remain closed with no timeline to reopen. The health system said it is in active communication with emergency response teams and will reopen each facility once crews clear the area and deem it safe, at which point it will activate an opening plan and notify the community.”
  • Better Report tells us.
    • “We spoke with board-certified emergency medicine physician Dr. Joseph Radachy about what he wishes more patients would prioritize. From simple ways to avoid everyday accidents to daily practices that support long-term health, here are six things your doctor wishes you’d do.
      • Stay Active Physically and Medically
      • Make your House Safer.
      • Advocate for Yourself
      • Know your Medical History
      • Remember: Moderation in Everything
      • Stop Smoking
  • The New York Time asked experts whether the bland BRAT diet is the best way to treat a stomach bug.
  • The American Medical Association lets us know “what doctors want patients to know about dry eyes.
    • “Dry eye disease can cause burning, tearing and blurry vision. Learn what triggers symptoms, which treatments help and when to seek care.”
  • Beckers Behavioral Health informs us,
    • “The age-adjusted death rate for alcohol-induced deaths among U.S. adults aged 45 and older increased from 2014 to 2024, according to an Aug. 20 report from the CDC’s National Center for Health Statistics.
    • “Death rates increased from 19.5 per 100,000 population in 2014 to 25.2 in 2024. In 2024, the death rate was 36.8 among men and 14.3 among women. Death rates were higher among men than women throughout the 2014–2024 period.
    • “The findings are based on National Vital Statistics System mortality data.
  • Parkinson’s News Today points out,
    • “Parkinson’s disease involves the progressive loss of dopamine-producing neurons, leading to motor symptoms.
    • “Starting rehabilitation within the first year of a Parkinson’s diagnosis may be linked to longer survival.
    • “Delaying rehabilitation is associated with a progressively higher risk of mortality across all disability levels.”
  • Genetic Engineering and Biotechnology New notes,
    • “Cancer metastasis is responsible for at least two-thirds of cancer deaths. Drugs targeting the metastatic progression have largely failed, in part due to the lack of predictive models that would help identify the underlying mechanisms of metastasis.
    • “Now, new work reports the development of a multi-organ chip that mimics how cancer cells spread from vascular flow to distant organs—the first model of cancer metastasis of its kind. The chip includes compartments with millimeter-sized engineered human bone and lung tissues, and the vascular flow that contains circulating breast cancer cells and allows the dynamic cross-talk of the tissues being colonized.
    • “The key advantages of this advanced model of metastasis are that it is human and can be patient-specific,” said Gordana Vunjak-Novakovic, PhD, university professor and professor of biomedical engineering and professor of medical sciences at Columbia University. “It faithfully mimics some of the key aspects of human metastasis that are otherwise largely inaccessible for direct study.”
    • “This work is published in Science Translational Medicine in the paper, “Organ-specific colonization and niche remodeling in a human tissue model of metastasis.”
  • STAT News takes us “inside Moderna and Merck’s cancer vaccine triumph.
    • “The drugmakers overcame rampant doubts, logistical challenges, and the pandemic.”

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

  • Fierce Healthcare reports,
    • “Highmark Health closed the first half of the year with $17.5 billion in revenue and $2 billion in net income, bolstered by a significant turnaround at its insurance unit.
    • “The $2 billion in net income accounts for $911 million in non-cash gains from the company’s affiliations with Blue Cross and Blue Shield of Kansas City and Heritage Valley Health System.
    • “Highmark Health Plans posted $672 million in operating income through the first two quarters of 2026, an increase of $612 million compared to the first half of 2025. Highmark said in the announcement that it expects elevated utilization and cost trends to persist across the industry, though pressures have eased.”
  • and
    • “Berry Street, a nutrition care company, has merged with India-based Healthify to form what executives call the largest insurance-covered AI metabolic health platform in the U.S. 
    • “The merger combines Healthify’s AI technology, including its nutrition and metabolic health assistant Ria, with Berry Street’s nationwide network of more than 2,000 clinicians and insurance-covered nutrition and GLP-1 care. The companies say the goal is to offer AI-powered, clinician-backed metabolic health support accessible through health insurance.
    • “Financial details of the merger were not disclosed. Berry Street shared the news exclusively with Fierce Healthcare.”
  • Beckers ASC Review relates,
    • “Kaiser Permanente is advancing construction plans for its long-planned Redlands, Calif., medical campus, with the Redlands Planning Commission set to review detailed site plans for the project’s first building Aug. 25, Community Forward Redlands reported  Aug. 24.
    • “The commission will consider a 113,000-square-foot, three-story medical office and ASC at Kaiser’s existing property. The building, known as Medical Office Building/Ambulatory Surgery Center 2, would house urgent care, outpatient surgery, chemotherapy infusion, imaging, laboratory services and medical offices.”
  • and
    • “Becker’s has reported on more than 30 ASC closures in 2026 as outpatient surgery facilities cite consolidation, efficiency and shifting care sites. 
    • “[The article offers] a look inside five more recent ASC closures as the industry battles reimbursement declines, staffing shortages and shifting market power dynamics. 
  • Healthcare IT News tells us,
    • “Telemedicine has made it routine for clinicians and patients to connect by video. But for health systems, establishing that connection is no longer the hardest part of virtual care. The bigger challenge is making sure the right patient gets a virtual visit in the first place – and that everything that should happen afterward actually happens.
    • “For telehealth veteran Dr. Joe Kvedar, professor of dermatology at Harvard Medical School and senior clinical advisor and two-time board chair at the American Telemedicine Association, the operational issues confronting provider organizations now come down largely to two areas: EHR integration and patient triage.
    • “Many health systems have made substantial progress integrating telemedicine into the electronic health record, says Kvedar, but determining which patients and conditions truly belong in a virtual encounter remains more difficult.”
  • and
    • “For decades, hospitals have largely treated discharge as the end of the acute care journey. Once patients left the building with a folder of instructions and follow-up recommendations, responsibility shifted largely to them and their families.
    • “But that approach is becoming increasingly difficult to sustain as hospitals assume greater accountability for patient outcomes long after patients leave inpatient care.
    • “New payment models, continued pressure to reduce avoidable readmissions and growing expectations for coordinated care are forcing provider organizations to rethink what happens after discharge.
    • “For Dimer Health CEO Caroline Hodge, PA-C, the answer is straightforward: Transitional care must become an active, technology-enabled extension of the hospital, rather than a passive handoff.
    • “The first 90 days aren’t an afterthought anymore,” Hodge said. “They’re where the outcome, and the economics, actually get decided.”
  • MedTech Dive informs us,
    • “MiniMed has begun shipping its new insulin pump in the U.S. with the Abbott-made Instinct sensor, the Medtronic spinout said last week. The sensor can be used for up to 15 days before it needs to be changed.
    • “The company said the rollout of its new MiniMed Flex delivery device with Instinct combines the smallest and only app-controlled insulin pump with the world’s smallest sensor.
    • “MiniMed is supporting the launch with its first major marketing campaign for the insulin pump. The campaign focuses on MiniMed Flex’s “discreet” design, app control and automation.”
  • Beckers Hospital Review notes,
    • “Mark Cuban Cost Plus Drug Co. has partnered with RxSaveCard and nonprofit Golden Thread to streamline sourcing and reduce costs of pediatric cancer clinical trial medications. 
    • “Once enrolled in a study, patients will sign up for RxSaveCard and receive trial medications delivered to their homes through Cost Plus Drugs, according to a news release shared with Becker’s.
    • “No study should stall over the price of a generic drug and no family should wait on one,” Alan Bowe, chief commercial officer at Cost Plus Drugs, said in the release. “We’re proud to work with Golden Thread and RxSaveCard to make trial medications affordable and deliver them directly to patients’ doors and we hope every trial that needs this model uses it.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Mental health care, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Hill reports,
    • “Lawmakers are sounding the alarm over the nation’s $40 trillion debt, lamenting Congress’s inability to meaningfully confront a problem that has grown increasingly difficult to ignore.
    • “Both parties have spent years trying to tackle the rising debt. Republicans have frequently pointed to federal spending and entitlement programs as the main drivers, while Democrats have emphasized the need for higher taxes on wealthy Americans and corporations alongside spending reforms.
    • “But efforts to reach a broader deal have repeatedly stalled as both parties have balked at the politically painful trade-offs needed to put the nation on a more sustainable fiscal path.” 
  • Modern Healthcare relates,
    • “A Senate bill [S. 3097 – Health Information Privacy Reform Act] would create medical privacy protections for consumer health products such as wearables and wellness apps.
    • “The legislation unanimously passed the Senate health committee last month and a similar bill is pending in the House.
    • “Stronger privacy rules could hamper some tech companies while benefiting others as well as providers eager to tap into new technology.”
  • Per a CMS news release,
    • “The Trump Administration announced an additional $4.2 million, made possible through the federal Rural Health Transformation Program (RHTP), is being put to work in West Virginia to expand patients’ transportation options and remove service barriers.
    • “By injecting millions into the Rural Health Link initiative, the Administration is upending the status quo that has limited transportation options for residents in need of critical healthcare services and delivering on its commitment to West Virginians who deserve the best access to care no matter their zip code. These funds will help increase medical transportation capacity, service availability, and improve geographic coverage for patients across the Mountain State.” 

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

  • Today’s Washington Post included an oped written by OPM Director Scott Kupor about his agency’s efforts to improve the merit system.
    • “At the Office of Personnel Management — Washington’s chief HR agency — my team has spent the past 20 months reforming this system. Our goal is simple and uncontroversial: Merit matters, not how long employees have been in a role or what college degree they earned, both in hiring and in day-to-day performance. That means accountability for employees who can’t deliver and distinction for those who knock the cover off the ball.”
  • Govexec adds,
    • “An agency spokeswoman said that a four-person communications team — all under the age of 30 — is spearheading the effort to make OPM’s social media more appealing to younger potential hires.”
  • Tammy Flanagan writing in Govexec, lets us know,
    • “Retiring from federal service is a major milestone, of course, but it does not end the need to understand how federal benefits work. In the years after retirement, life events and new opportunities can raise important questions about insurance, survivor benefits, beneficiary designations and the effect of returning to government employment.
    • “Today I will highlight several post-retirement issues that federal employees may want to plan for in advance. This is not an all-inclusive list, but it’s a list that will hopefully remind you that it is important to review your benefits and be sure to understand how they can change as life goes on.” * * *
    • “Health benefits can also change after retirement, not only the premiums and the benefits, but your needs may change over time. Outside of open season, FEHB changes generally must be tied to a Qualifying Life Event (QLE), such as marriage, divorce, death of a family member, or a move out of a plan’s service area, and many changes must be requested within 60 days of the event.
    • “Annuitants should confirm the effective date with OPM because the timing can depend on the type of change. For example, some enrollment decreases may be made at any time and are commonly effective at the beginning of the month after OPM receives the election, while other changes follow the qualifying life event rules.
    • “There is a little-known option to change insurance just because you have reached age 65, it is QLE 2L. This is your “ace in the hole” that you can only use once in your lifetime to change plans outside of open season.
    • “This is generally used to change plans when enrolling in Medicare after retirement, but if not used at age 65, it can be used later – but only once!”

From the Food and Drug Administration front,

  • CBS News reports,
    • “A New York-based consumer healthcare company is recalling nearly 40,000 bottles of eye drops over concerns about the product’s sterility. 
    • “Prestige Consumer Healthcare initiated the recall on July 29 due to “lack of assurance of sterility,” according to a U.S. Food and Drug Administration notice.
    • “The recall is due to potential contamination,” the notice says.
    • “The recall affects 15mL bottles of Clear Eyes’ Maximum Itchy Eye Relief, which mitigates itchiness, redness and other eye irritations, according to the product description. The eye drops were distributed nationwide.”
  • Fierce Pharma relates,
    • “If at first you don’t succeed in gene therapy, then try, try again. That’s the lesson Ultragenyx likely took home this week as it pocketed its first FDA nod in the class just over a year after a separate program stalled on manufacturing grounds. 
    • “Late Wednesday, the FDA gave an accelerated go-ahead to pariglasgene brecaparvovec-opnr, Ultragenyx’s AAV gene therapy for the rare genetic disorder glycogen storage disease type Ia (GSDIa), which will now head to market with the brand name Genglycos. 
    • “The accelerated approval specifically covers the gene therapy—previously coded as DTX401—in adults and kids over the age of 8 years with GSDIa, an ultrarare genetic disorder driven by a deficiency of the enzyme G6PC, which is needed to release glucose from the liver into the bloodstream. The liver is less capable of controlling glucose levels in these patients, leading to potentially life-threatening hypoglycemia episodes and other complications. 
    • “By Ultragenyx’s reckoning, there are between 1,500 and 2,500 people living with GSDIa in the U.S. out of an estimated global patient population of 6,000 to 8,000 “within commercially accessible geographies,” the company said in an Aug. 19 release.” 
  • HCPLive tells us,
    • “The U.S. Food and Drug Administration (FDA) has approved Glenmark Pharmaceuticals’ fluticasone propionate nasal spray, USP, 0.05 mg (50 mcg)/spray, a generic version of Haleon’s Flonase Nasal Spray indicated for nasal symptoms of allergic rhinitis, the company announced on August 20, 2026.¹
    • “The approval of fluticasone propionate nasal spray, USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area,” said Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals. “We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.” * * *
    • “FDA approval was secured through the bioequivalence pathway, so no independent clinical efficacy or safety program accompanied authorization beyond equivalence to the reference product.” * * *
    • “Distribution will be handled by Glenmark Pharmaceuticals Inc., USA, while pricing and launch timing were not disclosed.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A growing number of Americans say their cannabis use is problematic, according to a large new study released Wednesday.
    • “The study, based on nationally representative data of U.S. adults, found that more than 9 percent of the men — or almost 1 in 10 — reported symptoms of cannabis use disorder in 2024, up from about 7 percent in 2021. The prevalence of cannabis use disorder also rose among women, increasing to nearly 6 percent in 2024, up from about 5 percent in 2021. Symptoms of the disorder include not being able to cut back or quit, or continuing to use the drug despite it leading to interpersonal problems.
    • “The notion that cannabis is not addictive may basically be incorrect,” said Dr. Nora D. Volkow, the director of the National Institute on Drug Abuse and the paper’s senior author.”
  • and
    • “There is no one-size-fits-all approach to managing treatment-resistant depression.
    • “At the UC Davis clinic, if patients don’t improve after trying two antidepressants in succession and undergoing psychotherapy, they may be prescribed a low dose of an additional drug such as an atypical antipsychotic or lithium, Dr. Debra Kahn, director of the Advanced Psychiatric Therapeutics Clinic at UC Davis Health said. Clinicians will ensure that medical problems that could be contributing to symptoms are addressed, too.
    • “One additional therapy that has been shown to help people with treatment-resistant depression is transcranial magnetic stimulation, or T.M.S., which was cleared by the U.S. Food and Drug Administration to treat depression in 2008, Dr. Kahn said. It uses magnetic pulses to stimulate parts of the brain to release mood-boosting chemicals including norepinephrine, dopamine and serotonin, she said.
    • “T.M.S. is tolerated well and has no long-term serious side effects, Dr. Kahn said. * * *
    • “Ketamine, an anesthetic commonly used in surgery, is increasingly used to address treatment-resistant depression. In 2019, the FDA approved Spravato, an intranasal spray containing esketamine. In a 2019 trial, 52.5 percent of patients with treatment-resistant depression who took esketamine with an antidepressant for 28 days experienced a significant resolution of their symptoms compared with about 31 percent of people who took an antidepressant with a placebo.” * * *
    • [T]here is unlikely to be one “magic pill” that cures treatment-resistant depression, Dr. Kahn said. People may benefit from a combination of approaches, and they may also need to combine treatments with lifestyle changes.”
  • MedPage Today tells us,
    • “The relationship between physical activity and dementia risk may depend on whether the activity is recreational exercise or job-related labor, a study of more than 4.2 million people suggested.
    • “High physical activity levels were linked to a 20% lower risk of all-cause dementia (relative risk [RR] 0.80, 95% CI 0.75-0.86) over 10 years compared with the lowest level of physical activity, reported Natan Feter, PhD, of the University of Southern California in Los Angeles, and colleagues in a systematic review and meta-analysis.
    • “Leisure-time activities like walking, running, swimming, cycling, or playing sports followed a similar pattern and were tied to lower dementia risk (RR 0.76, 95% CI 0.65-0.88), the researchers wrote in Lancet Public Healthopens in a new tab or window. Household physical activity also appeared beneficial, but evidence was from a single study.”
  • and
    • “A recent report advocated against using BMI as a standalone tool in measuring health risk.
    • “Longitudinal data suggested that high waist circumference was associated with elevated mortality risks, while high BMI was tied to lower mortality risks, among older adults.
    • “Underweight status was associated with a higher mortality risk compared with normal weight in both men and women, regardless of waist circumference.”
  • The American Medical Association lets us know “what doctors want patients to know about mosquito bites.
    • “Mosquito bites spark immune reactions from itchy bumps to Skeeter syndrome and severe illnesses, but prevention and knowing warning signs can reduce risks.”
  • Cardiovascular Business informs us
    • “Transcatheter aortic valve replacement (TAVR) continues to gain momentum as a go-to treatment option for severe, symptomatic aortic stenosis. However, surgical aortic valve replacement (SAVR) remains a significantly safer option for patients 60 years old and younger, researchers confirmed in a new study published in JTCVS Open.[1]
    • “Current guidelines recommend SAVR for patients younger than 65 years, yet an increasing number of younger patients are undergoing TAVR with uncertain long-term results,” wrote first author Jessan A. Jishu, MD, with the Tulane University School of Medicine, and colleagues. “Given this lack of clarity and growing real-world adoption of TAVR among younger individuals, this study uses a large-scale database representative of practices in the United States to confirm the findings from these previous studies by assessing short- and long-term outcomes of SAVR versus TAVR in patients younger than 60 years, a population in whom long-term durability and reintervention risk are of particular concern.”
    • “Jishu et al. explored the TriNetX database, exploring real-world data from nearly 10,000 patients who underwent TAVR or SAVR from 2006 to 2025. Approximately 80% of patients were treated with SAVR, but TAVR grew more common from 2020 to the end of the study.”
  • and
    • “A Cedars-Sinai Health Sciences University-led study has identified molecular changes that appear to trigger atherosclerosis years before inflammation, sharing their findings in European Heart Journal.
    • “The group believes this could a key discovery in the development of next-generation early prevention therapies. 
    • “The study’s authors found previously unrecognized molecular pathways and a possible master regulator protein called MLXIPL that could become future targets for clinicians working to stop plaque from ever developing.
    • “We analyzed proteins and gene activity in coronary artery tissue from young adults who died of trauma and had no known coronary artery disease, and we found that more than half already had preclinical atherosclerosis,” first author Sarah Parker, PhD, an associate professor of cardiology and biomedical sciences and co-director of the proteomics and metabolomics core at Cedars-Sinai Health Sciences University, said in a statement. “This suggests that changes in cellular metabolism and communication begin before the inflammation long considered a hallmark of the disease.”
    • “Parker said this research provides a direct picture of what is happening inside the artery wall and may explain why some people are more vulnerable to heart disease than others.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of ifezuntrigene inilparvovec (uniQure N.V.) for Huntington’s disease. This therapy is also known as AMT-130.
    • “The assessment will be publicly discussed during a meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in March 2027, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
    • “Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including relevant patient groups, and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.”  

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

  • The Wall Street Journal reports,
    • “Surging healthcare costs are walloping U.S. workers, and they will only worsen next year. For 2027, employers may be facing the biggest health-insurance increase in at least two decades.
    • “Americans with workplace coverage are expected to spend an average $5,297 this year on healthcare, $388 more than 2025, according to a new estimate from benefits-consulting firm Aon. The spending represents a combination of payroll deductions for premiums and out-of-pocket charges like deductibles and copays.
    • “The burden is likely to grow significantly next year, when U.S. employers expect their healthcare costs to go up by 11.1%, according to a new survey from WTW, another big benefits consultant—the steepest rise in more than 20 years.
    • “That would represent the fifth year of escalating increases, according to WTW. “Employers are telling us that this is utterly unsustainable,” said Jeff Levin-Scherz, population-health leader at WTW. Expensive cancer treatments and wide adoption of weight-loss drugs are among the factors pushing up spending.”
  • and
    • “Costco sells its dedicated members everything from travel packages to gasoline. Now the retail giant is gearing up to enter a huge new market: Medicare. 
    • “The warehouse chain plans a limited rollout of Costco-branded Medicare plans, working with SCAN Group, a nonprofit insurer. Nationally, Medicare is a more than $600 billion business for insurers, but the two companies said they would start by selling their jointly named Medicare Advantage products in two states, and a Medicare supplement in a third. 
    • “SCAN and Costco executives said the three target markets include around five million Medicare enrollees but declined to disclose exact locations or timing, citing regulatory limits on disclosure pending approval by the Medicare agency.
    • “SCAN is based in Long Beach, Calif., and Southern California is a core market for the nonprofit, which focuses on Medicare and has about 460,000 members. SCAN also offers Medicare Advantage plans in Arizona, Nevada, New Mexico, Texas and Washington state.”
  • Modern Healthcare adds,
    • “Centene is scaling back its Medicare Advantage presence next year as the health insurance company looks to cut costs. 
    • “The insurer plans to completely withdraw from Oklahoma, Tennessee and Hawaii, according to a notice the company distributed to third-party marketing organizations last week.
    • “Centene is also preparing to exit at least 158 counties and cancel 133 Medicare Advantage plans, according to a Modern Healthcare analysis. Modern Healthcare compared the company’s list of available policies for 2027 to the Centers for Medicare and Medicaid Services enrollment file for this month.
    • “The cancellations would drive about a third of Centene’s Medicare Advantage membership, or more than 340,300 enrollees, to shop for new coverage, according to the Modern Healthcare analysis. Members may have alternative Centene plans from which to choose.” 
       
  • The Health Care Cost Institute released a report about the “Effects of vertical integration on providers’ billing and practice patterns in Medicare (2018-2022)”
  • Fierce Healthcare notes,
    • “The blockbuster success of GLP-1 weight loss drugs has caused major ripple effects across healthcare and pharma, representing a significant growth engine for drugmakers but a cost challenge for payers.
    • “GLP-1s are also potentially disrupting a healthcare system built around treating obesity-related complications, forcing providers, insurers and investors to rethink where future revenue and growth will come from, according to a new report from Wells Fargo.
    • “For decades, the healthcare industry has built service lines, reimbursement models and care pathways around the downstream consequences of obesity. Diabetes clinics, cardiology service lines, sleep medicine, orthopedics, bariatric surgery, pharmacy and chronic disease management have all grown inside a system where obesity was widespread, persistent and often untreated.
    • “GLP-1s may be starting to upend that model as the growing use of obesity drugs begins to influence utilization patterns, hospital economics, pharmaceutical R&D and long-term healthcare spending, wrote Robin Wenzel, head of Wells Fargo Industry Insights and John Teasley, market executive, Wells Fargo Healthcare Banking, in the report.
    • “The latest data from the Centers for Disease Control and Prevention and the National Center for Health Statistics indicates that 40.3% of U.S. adults have obesity, and 9.4%, roughly one in ten, have severe obesity. That makes obesity not an outlier, but a baseline condition around which much of U.S. healthcare now operates, the report authors assert.
    • “GLP-1 drugs for weight management move the management of obesity upstream, to prevention in the context of a system designed around late-stage disease. That puts traditional obesity-related service lines, and healthcare’s obesity revenue engine, under pressure, according to the report.”
  • Beckers Hospital Review points out how 14 large health systems performed financially during the three months ended June 30, and tells us,
    • “New CMS data shows emergency department visit times climbed in the vast majority of states compared with the same period last year, though wide variation persists across the country.
    • “The agency’s “Timely and Effective Care” dataset covers children and adults treated at hospitals paid under the Inpatient Prospective Payment System or Outpatient Prospective Payment System, as well as those that voluntarily report data on relevant measures. Data was collected in the 12-month period ending Sept. 30, 2025. Learn more about the methodology here.
    • :Nationwide, the median time patients spent in the ED was 162 minutes for the 12-month period ending September 2025, stable from the same period a year prior, according to CMS data.:
  • Healthcare Dive notes,
    • “Name: Dr. Shantanu Nundy
    • “Previous title: Executive vice president of care delivery and chief health officer, Accolade
    • “New title: Chief medical officer, Humana
    • “Nundy will become Humana’s new CMO effective Aug. 31, the Kentucky-based insurer announced Thursday.
    • “He’s replacing Kate Goodrich, who served as CMO from 2022 to October 2025, when she left for a role in the health services division of Humana’s rival insurer UnitedHealth. The CMO post has sat empty since.
    • “As CMO, Nundy will help design Humana’s products, platforms and use of artificial intelligence with a clinical eye, according to the release.”
  • and
    • “Name: Arun Kumar Bhaskara-Baba
    • “Previous title: Chief information officer, Honeywell Aerospace and Defense
    • “New title: Chief information officer, Mayo Clinic
    • “Bhaskara-Baba joined Mayo Clinic as CIO in May, the Minnesota-based health system confirmed in a statement. He’s at the helm of Mayo’s information technology systems across its network of 16 hospitals and 45 multispecialty clinics.
    • “Bhaskara-Baba is succeeding Cris Ross, who retired in 2024 after 12 years in the role.
    • “Bhaskara-Baba brings more than 25 years of tech experience to the role. He joins Mayo from Honeywell Aerospace and Defense, where he directed digital strategy and scaled the company’s artificial intelligence capabilities as CIO.”
  • Fierce Healthcare informs us,
    • “Cityblock Health, a company primarily focused on providing care for urban Medicaid and dual-eligible members, plans to acquire Homeward Health to expand deep into rural markets, the company announced Thursday.
    • “Combined, the two companies will serve nearly 250,000 people and are positioned to reach the 120 million people receiving government-funded healthcare in the U.S., Toyin Ajayi, Cityblock Health CEO and co-founder, wrote in a blog post.
    • “Cityblock said it signed a definitive agreement to acquire Homeward in an all-stock transaction. Financial details of the deal were not disclosed.”
  • and
    • “Carrum Health, a company with value-based Centers of Excellence for employers, is teaming up with Included Health, a virtual care and health navigation company working with employers and plans.
    • “Carrum’s Centers of Excellence network for specialty care will be embedded directly into Included Health’s Alternative Health Plan to help connect members to high-quality specialty care with more predictable costs. The partners will connect plan design, navigation and value-based care into one coordinated experience. 
    • “As employers face steep healthcare cost increases, specialty care often drives a lot of healthcare spending. From 2023 to 2025, the U.S. saw the highest three-year stretch of healthcare cost growth in over a decade, according to the Business Group on Health. The Carrum integration will deliver greater cost predictability with bundled rates, outcomes accountability and streamlined contracting.”
  • Healthcare Dive adds,
    • “Healthcare revenue cycle management company R1 has agreed to acquire Humata Health, a company specializing in artificial intelligence-powered prior authorizations.
    • “R1 is banking that Humata’s AI expertise will help it streamline the preapproval process required by insurers for certain medical treatments, and further its goal of automating how healthcare providers get paid for their services.
    • “The acquisition is expected to close in the third quarter this year, after which Humata’s team will start integrating its technology into R1’s revenue cycle platform. An R1 spokesperson declined to share the financial terms of the deal.”

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Electronic health records, FDA, Federal employment benefits, HSA, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC

  • Beckers Hospital Review reports,
    • “The U.S. national debt surpassed $40 trillion for the first time Aug. 19, adding another layer of financial uncertainty for hospitals already navigating elevated borrowing costs and significant federal reimbursement pressures, according to The New York Times. 
    • “The news comes as the federal government is on track to borrow more than $2 trillion this year, with rising interest expenses consuming an increasingly large share of federal spending, according to the report. 
    • “The knock-on effects extend far beyond the federal government’s balance sheet. Higher Treasury yields can increase hospitals’ cost of capital, while the deteriorating fiscal outlook could intensify scrutiny of Medicare, Medicaid and other federal healthcare programs already targeted by the Trump administration for spending reductions.”
  • STAT News relates,
    • “Erica Schwartz, the new director of the Centers for Disease Control and Prevention, told agency staff on Wednesday that she was prepared to disagree with administration leaders and sought to empower others to do the same, according to a recording of the meeting obtained by STAT.
    • “During her first all-hands address on Wednesday, Schwartz identified three priorities: preserving trust through radical transparency and scientific rigor; strengthening the CDC’s ability to respond to disease threats; and building up the agency’s relationship with state and local partners.”
    • “She said she was ready to stand up to health secretary Robert F. Kennedy Jr. if needed to accomplish those goals.
    • :Schwartz said she wasn’t blind to what her predecessor, Susan Monarez, went through — being fired because she wouldn’t agree to follow Kennedy’s orders on vaccine policy — and said she was clear with Kennedy she would act and share information as a physician.
    • “I feel very comfortable and very confident, already having like three or four meetings with them since I started this position, of speaking truth to power,” she said. “I do not feel at all challenged with speaking, you know, what the science tells me and what you all are telling me to represent for the CDC.”
  • Per a CMS news release,
    • “The Trump Administration announced a $90 million investment is being delivered to South Dakota through the federal Rural Health Transformation Program (RHTP) to accelerate digital health modernization, strengthen cybersecurity, and enhance interoperability across rural and underserved communities. This investment will strengthen South Dakota’s health 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.”
  • Beckers Payer Issues tells us,
    • “The average end-of-year balances for health savings accounts reached $5,532 in 2024, up from $4,747 the year prior.
    • “However, that balance fell far below out-of-pocket maximums. In 2025, out-of-pocket maximums for HSA-eligible health plans were $8,300 for individual coverage and $16,600 for families.
    • “The Employee Benefit Research Institute released an issue brief Aug. 13 detailing HSA trends from 2011 through 2024. The institute formed its HSA database more than a decade ago. As of the end of 2024, the database had 15.2 million accounts with total assets of $53.7 billion.
    • “The report outlined the “triple tax advantage” of HSAs: tax-free contributions, tax-free growth and tax-free qualified withdrawals.”
  • Fierce Healthcare points out,
    • “While many individuals believe they have a firm grasp on their Medicare benefits, the reality is far different, according to a new survey.
    • “Insurance agency eHealth conducted a survey of 1,000 Americans and found that 89% of beneficiaries feel “confident” that they understand their Medicare benefits and coverage options. However, just 13% could identify each of the main facets of Medicare, such as the traditional program, Medicare Advantage, Part D and Medicare supplement plans.
    • “In addition, most (88%) said they did not know there is no annual cap on out-of-pocket spending in traditional Medicare, while 82% of those nearing Medicare eligibility said they were not aware that there is a 20% coinsurance for medical services.
    • “Close to half (42%) of beneficiaries were unaware or underestimated that 20% coinsurance, according to the report.”
  • Beckers Behavioral Health informs us,
    • “The percentage of U.S. adults who report doing any kind of gambling during the past year fell to 45%, down from 64% a decade ago, according to an Aug. 17 report from Gallup. 
    • “The findings are based on telephone interviews conducted by ReconMR June 1 to July 19, 2026, with a random sample of 2,201 adults, aged 18 and older, living in all 50 U.S. states and the District of Columbia. Gallup also conducted a web survey from June 1-15, 2026, with a stratified random sample of 2,043 adults, aged 18 and older, who are members of the Gallup Panel.’ 

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

  • FedWeek lets us know,
    • “The [Federal Employee Benefits] open season this year will run November 9-December 14. Available plans and their premiums for the upcoming year typically are announced a month or so in advance, with fuller details released just ahead of the enrollment period.”
  • OPM Director Scott Kupor made his latest post to his Secrets of OPM blog available on LinkedIn today. The post concerns a recent OPM employee survey.

From the Food and Drug Administration front,

  • CBS News reports,
    • “The Food and Drug Administration upgraded a recall of frozen blueberries and mixed berries sold at Publix grocery stores across the U.S. to the highest health risk level on Tuesday, according to an enforcement report.” 
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) to reduce daily cornstarch intake as an adjunct to nutritional management in adults and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa), a rare, inherited genetic disorder caused by a deficiency of the enzyme glucose-6-phosphatase, which prevents the body from properly breaking down stored glycogen into glucose. Genglycos is the first approved treatment for this condition.
    • “The accelerated approval pathway allows the FDA to approve certain drugs or biologics intended to treat a serious or life-threatening disease or condition if the agency determines the treatment has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
    • “Patients with GSDIa face possible life-threatening complications and have limited treatment options that include primarily life-long, strict dietary management,” said Karim Mikhail, B. Pharm., M.S., acting director of the Center for Biologics Evaluation and Research (CBER). “Today’s approval is a great milestone in using a gene therapy to treat this disease and improve the quality of life for people with this condition.”
  • and
    • “The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time, which may help address the current phlebotomist shortage in the U.S.
    • “This authorization reflects the FDA’s commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists.”
  • Fierce Pharma tells us,
    • “After more than 10 years in development, Regeneron secured a landmark approval for its monoclonal antibody garetosmab, now commercially known as Pasatru. The drug has become the second cleared by the FDA to treat fibrodysplasia ossificans progressiva (FOP) and the first to reduce clinician-assessed flare-ups in adults with the disease.
    • “Pasatru, given intravenously every four weeks, is designed to block what is believed to be the key protein behind the FOP disease process—activin A—which was pinpointed by Regeneron scientists as a possible target for treating FOP more than a decade ago. 
    • “The approval follows a victory last year in a phase 3 study, which randomized 63 adults with FOP to receive one of two doses of the anti-activin A antibody or placebo every four weeks for 56 weeks. In the trial, both high- and low-dose Pasatru reduced new bone lesions in FOP patients by 90% over 56 weeks. And high dose Pasatru reduced bouts of painful localized inflammation by 89% compared to placebo, too.
    • “By the end of the trial, an independent data monitoring committee recommended all patients on placebo be switched to Pasatru as soon as possible.” 

No Surprises Act News,

  • Modern Healthcare reports,
    • “Providers are triumphing against insurers in bitter out-of-network billing battles at a record pace and by an unprecedented margin.
    • “President Donald Trump enacted the No Surprises Act in 2020. The law succeeded in protecting patients from many surprise medical bills. But its baseball-style arbitration system was quickly overwhelmed.
    • “Independent Dispute Resolution filings represent a tiny percentage of commercial health insurance claims, but cases have increased each year since the process debuted in 2022. Disputes rose almost 75% to more than 2.5 million from 2024 to 2025, according to an analysis of Centers for Medicare and Medicaid Services data the Niskanen Center published in July. CMS originally projected there would be about 17,000 cases a year.
    • “Providers won 83.6% disputes in the fourth quarter of 2025, a share that’s been consistent since 2023, according to the Niskanen Center, a centrist think tank.
    • “Provider groups maintain these wins are warranted and arbitrators have agreed. Publicly held insurers including UnitedHealth Group subsidiary UnitedHealthcare, CVS Health subsidiary Aetna and Elevance Health contend out-of-network providers are abusing the system. Last month, CMS acknowledged arbitration is not working as intended and suggested it would take action.
    • “When we look at other models of arbitration, the win rates tend to be 50-50, and it tends to be a pretty rare option of last resort,” said Christopher Whaley, a health economist at Brown University. ”Obviously, that’s not happening in the No Surprises Act arena.”
  • FEHBlog observation: The NSA IDR rules stack the deck in favor of the providers who have inside information on the provider’s credentials and the patient’s acuity.

From the judicial front,

  • Fierce Pharma reports,
    • “In their attempts to challenge the Medicare drug price negotiation program, introduced by former President Joe Biden under the Inflation Reduction Act (IRA), biopharma companies have been largely shut out in federal courts.
    • “On Tuesday, however, Teva Pharmaceuticals gained a partial win as the U.S. Court of Appeals for Washington, D.C. sent (PDF) a previous ruling back to the District Court for further review. It concerns Teva’s challenge to the requirement by the Centers for Medicare & Medicaid Services (CMS) that a generic drug be genuinely marketed before its brand-name reference product is excluded from negotiation.
    • “The appeals court did not decide on the legality of the CMS’s “bona fide marketing” standard. It only determined that it should be considered by the lower court. 
    • “The district court never addressed whether CMS’s standard comports with the IRA, and we leave that question for it to consider in the first instance,” Circuit Judge J. Michelle Childs wrote.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Packaged-food makers are testing new strategies to appeal to consumers using GLP-1 weight-loss drugs, which suppress hunger and alter taste.
    • “JPMorgan estimates that GLP-1 treatments could drain $30 billion to $55 billion in annual revenue from the food and beverage industry by 2030.
    • “Companies like Conagra and General Mills are developing protein-rich products aimed at GLP-1 users.”
  • Health Day adds,
    • “Are you worried that extra pounds might be harming your health?
    • “Check the notches on your belt, a new study suggests.
    • “Waist size might be one of the simplest and most effective measures to detect health risks associated with obesity, researchers reported recently in JAMA Network Open.
    • “Pay attention to the need to loosen your belt or get bigger pants,” lead researcher Dr. Aayush Visaria said in a news release. He is a faculty member at Rutgers Health-RWJBarnabas Health Center for Climate, Health, and Healthcare in New Jersey. 
    • “Although clothing size isn’t the same as a proper waist circumference measurement, it can be an early sign of unhealthy amounts of body fat,” Visaria said. “Measuring your waist, along with your weight, can help identify health risks earlier and provide an opportunity to reduce your risk of diabetes, heart disease, stroke and some cancers.”
  • Cardiovascular Business relates,
    • “Rates of heart failure (HF) in the United States are stable or even beginning to decline. When it comes to HF with preserved ejection fraction (HFpEF), however, the numbers are on the rise. 
    • “This prompted the American College of Cardiology (ACC) to create an expert consensus decision pathway document focused on the efficient management of HFpEF patients.[1]
    • “The new document represents an update of the ACC’s 2023 recommendations, exploring new data to provide an abbreviated, practical guidance for patient management. The format was revised to associate treatment algorithms and tables to match the evolving clinical evidence.
    • “Despite advances in HF therapy, it remains a major consumer of healthcare resources and death worldwide. HFpEF accounts for more than 50% of new cases of HF each year and has outcomes comparable to heart failure with reduced ejection fraction (HFrEF). However, the consensus authors said HFpEF is often underdiagnosed and results in substantial resource utilization.”
  • and
    • “The use of artificial intelligence (AI) to identify incidental cardiac findings is a growing area of research, and now the identification of aortic stenosis (AS) is being tested on noncardiac chest CT scans. Cedars-Sinai Medical Center researchers are conducting a real-world study of an opportunistic algorithm that looks at all chest scans for the hallmark signs of AS.
    • “Some imaging experts have said this specific use of AI could serve as an early screening system to catch patients with heart disease years before they would become symptomatic, adding diagnostic value beyond why these scans were originally ordered. AS is one of the most common and serious heart valve disease problems, but most patients are unaware they have it at first and go undiagnosed until they become symptomatic. The American Heart Association (AHA), for example, believes there is still a sizable population of patients who remain undiagnosed or untreated.” 
  • Medscape offers physicians “Five Steps to Earlier Heart Failure Detection.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded scientific team has shown that under the right circumstances, 3D cell culture models of human brain tissue, known as organoids, can express features of later stage brain development. This breakthrough could turn previously unattainable, long-term, benchtop studies of neurodevelopmental disorders into a reality.
    • “The unprecedented longevity and lifelike qualities of these tissue models could afford us the opportunity to dig deeper into how conditions such as autism emerge and unfold later in life,” said Andrea Beckel-Mitchener, Ph.D., acting director of NIH’s National Institute of Mental Health (NIMH).”
  • Genetic Engineering and BioTechnology News adds,
    • “The Human Cell Atlas (HCA) was co-founded in 2016 by Aviv Regev, PhD, currently the head, executive vice president of research and early development at Genentech and Sarah Teichmann, FMedSci FRS, professor at the University of Cambridge and vice president translational research at GSK.
    • “This year, the group celebrated its 10-year anniversary, at the annual meeting in June, held in Boston. The first day was focused on the successes of the past decade. The second day looked ahead to the future, and the impact the HCA will make on research and drug discovery. GEN spoke with Holger Heyn, PhD, ICREA professor at the Centro Nacional de Análisis Genómico (CNAG) and co-founder of Omniscope about the meeting and what the next 10 years may bring. Heyn has been with the HCA since (almost) the beginning and currently serves as the co-chair of the Standards and Technologies working group, co-chair of the Industry Partnership Program, an organizing committee member, and a member of the task force to design HCA 2.0.”
    • The interview can be found in the article.
  • In the big research news of the day, the New York Times informs us,
    • “An experimental mRNA vaccine allowed people with high-risk melanoma to live longer, cancer-free, the pharmaceutical companies Moderna and Merck announced Wednesday.
    • “For decades, cancer vaccines have been one of the most tantalizing ideas in cancer treatment — offering the hope of harnessing a person’s own immune system to attack tumors.
    • “It’s a big deal,” said Dr. Elias Sayour, a pediatric oncologist at the University of Florida, who was not involved in the trial. The results, he said, “could help usher a whole new wave of new therapeutic treatments for cancer.” * * *
    • “The study is the most advanced of a number of trials testing the approach against a variety of cancers, including lung, bladder, kidney and pancreatic cancer. While small trials have shown the promise of the approach, the Moderna and Merck trial was seen as a bellwether in demonstrating the technology — and a first step toward transforming cancer care with treatments that are individualized to a person’s tumor and that may ultimately be able to stay ahead of it as it changes.”
  • The Wall Street Journal adds,
    • “Novo Nordisk is studying smaller doses of its Wegovy weight-loss pill to find the lowest dose that still allows patients to lose weight.
    • “The study began last week, has enrolled 450 overweight people and will test two low doses of the pill compared to a placebo.
    • “Novo Nordisk recently disclosed that uptake of the pill has been particularly strong for its lowest doses across self-paying patients.”

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

  • The Association of Healthcare Journalist reports,
    • “Investing more in primary care is linked to lower health care costs, according to a new report.
    • Journalists can cover this story nationally and locally, especially in rural areas where access to primary care can be more challenging, according to the report, “Investing in Primary Care: The Missing Strategy in America’s Fight Against Chronic Disease,” from the Milbank Memorial Fund.
    • “The report matters to reporters because it shows that adults and children with primary care physicians (PCPs) or a regular source of primary care have lower health care costs than those without.
    • “The report comes as Congress and President Trump are implementing changes under the 2025 budget reconciliation bill, cutting billions of dollars in federal Medicaid spending. Such a big decrease means low-income families could lose their Medicaid coverage, and not all physicians will treat the uninsured, the Milbank report notes. 
    • “The Milbank report is also timely because federal efforts since 2021 to increase the number of primary care doctors “have fallen short”, as Dennis Thompson reported for HealthDay. Primary care positions increased by just 2% under laws Congress passed in 2021 and 2023 to increase U.S. medical residencies, while residency positions in interventional radiology and psychiatry increased the most, rising by 16% and 13% respectively, he wrote, citing research JAMA published in June.” 
  • Beckers ASC Review adds,
    • “Physicians who once worked in a physician-owned practice before their current job are significantly more likely than their peers to be heading for the exit, according to the 2026 PAI Employed Physician Survey.
    • “Among physicians with prior experience in a physician-owned setting, 35% cite a lack of clinical autonomy as a reason they’re considering a new job, compared with 21% of physicians who’ve never practiced outside a corporate structure. They’re also more likely to say they plan to leave clinical practice entirely before retiring — 20% versus 12%.
    • “That group also reports operating under tighter terms: 63% are bound by a non-compete agreement, versus 48% of physicians without prior independent-practice experience, and 53% have patient-volume targets built into their compensation, versus 41%.”
  • Beckers Hospital Review relates,
    • “Altamonte Springs, Fla.-based AdventHealth recorded operating income of $916.2 million (13.4% operating margin) during the second quarter of 2026, up from $657.4 million (11.7% margin) during the same period last year.”
  • Beckers Health IT tells us,
    • “A year ago, health system CIOs walking the halls of Epic’s Users Group Meeting were still convincing themselves — and their boards — that generative AI in the EHR was more than a demo. This year, that debate is over. The new one is about speed.
    • “What strikes me overall is just the pace is blistering,” Tom Bentley, BSN, RN, chief information and digital technology officer of Columbus-based Ohio State University Wexner Medical Center, told Becker’s at the EHR giant’s sprawling headquarters in Verona, Wis. “Epic is cranking out new functionality, and I’m thinking what every CIO is thinking about: How do we increase our pace of adoption?”
    • “Epic used its Aug. 18 keynote to detail the scope of that push, including its Agent Factory platform that will soon allow health systems to build their own AI agents, the advancement of Cosmos-powered prediction tools called Curiosity, and the debut of an AI-assisted outpatient visit called Ergo.”
  • Beckers Payer Issues adds,
    • ‘The health systems and health plans that have pushed AI furthest into their operations are among the least equipped to prove what it is returning, according to a survey of 64 U.S. healthcare CFOs and finance leaders published Aug. 12 by Deloitte.
    • ‘Only 18% of organizations Deloitte classified as “AI scalers” said they have mature financial attribution capabilities, meaning they consistently measure AI’s effect on revenue growth or cost savings with defined baselines and clear ownership of key performance indicators. Among “AI starters,” 31% reported that level of maturity.’