Midweek report

OPM

Midweek report

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

Simplicity is a virtue.

From Washington, D.C.,

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

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

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

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

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

No Surprises Act News

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

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

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

No Surprises Act News

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

From the fraud, waste, and abuse front,

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

From the public health and medical / Rx research front,

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

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

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

Notable Deaths

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

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Never forget.

The New York Times reports

  • “Mourners and dignitaries gathered this morning in Lower Manhattan to honor the thousands of people who were killed on this day 25 years ago, when terrorists crashed two airplanes into the World Trade Center, shaking America and the world. It took four hours for family members of the victims to read aloud the names of all of the nearly 3,000 people who lost their lives: Gordon M. Aamoth Jr.; Edelmiro Abad; Marie Rose Abad …
  • “Solemn ceremonies were also held at the Pentagon and in Shanksville, Pa., where the other hijacked planes crashed. At the Pentagon, President Trump spoke of American resilience: “Sept. 11 reminded us of the terrible power of hate,” he said. “The 25 years since have shown us the even greater power of the American spirit to endure and prevail and to win.”
  • “All four other living presidents attended the memorial in New York. Zohran Mamdani, the city’s first Muslim mayor, was also in attendance, despite a petition signed by thousands of people, including the family members of some victims, urging him to stay away.
  • “That ceremony began, as always, at 8:46 a.m., with a beat of silence honoring the moment when the first plane, American Airlines Flight 11, struck the North Tower. Five more silences marked the times when other flights crashed and buildings fell. But this year, a new, seventh moment of silence was observed, to mourn those who have died from cancer and other illnesses inflicted by the toxic dust they inhaled after the attacks.”

From Washington, DC,

  • Tammy Flanagan, writing in Govexec, tells us,
    • Every year, the anniversary of Sept. 11, 2001, brings back the same difficult truth: federal service is not always performed behind a desk, and risk does not always announce itself in advance. Sixty-nine federal employees were among those who died that day — including 62 at the Pentagon, three at the World Trade Center, three aboard Flight 93, one aboard Flight 77 at the Pentagon and one aboard Flight 175 at the World Trade Center. Many more reported for duty afterward to secure facilities, investigate the attacks, transport people, provide emergency assistance and help the country recover.
    • For their families, the lesson is not only one of remembrance. It is also a benefits lesson. If a civilian federal employee is injured, develops an occupational illness or dies because of federal employment, the Federal Employees’ Compensation Act may provide important protection.
    • FECA is the federal government’s workers’ compensation program for civilian employees, administered by the Labor Department’s Office of Workers’ Compensation Programs. It can pay for medical treatment, replace part of lost wages, provide compensation for permanent impairment and, in fatal cases, provide benefits to eligible survivors.
    • This is where many employees and families get into trouble: They know there are “benefits,” but they do not know which benefit applies, who administers it or what evidence is needed. A traumatic injury is generally tied to a specific incident during one workday or shift and is reported on Form CA-1. An occupational disease or illness develops over more than one workday or shift and is reported on Form CA-2. Wage-loss compensation is generally claimed separately, often with Form CA-7.
    • These distinctions are more than paperwork. They affect deadlines, agency responsibilities, medical documentation and how the claim is developed.
  • FEHBlog observation: While OWCP pays benefits before FEHB /PSHB plans for OWCP compensable illnesses and injuries, OWCP does not give the beneficiary an OWCP benefits ID card which would put the provider on notice to bill OWCP, not the FEHB/PSHB plan.
  • Healthcare Dive reports,
    • “The number of hospitals complying with price transparency rules is increasing. But more than half of facilities still aren’t posting full information about the cost of their services, according to the latest analysis from PatientRightsAdvocate.org.
    • “About 51% of U.S. hospitals aren’t fully complying with the rules, despite them taking effect more than half a decade ago, according to the patient advocacy group’s latest scorecard of 2,000 hospitals.
    • “Still, the roughly 49% of hospitals in compliance is up significantly from the last time PRA analyzed the industry in 2024, and is the highest rate since the group began tracking the issue in 2021. PRA chalked the improvement up to regulators stepping up enforcement.”
  • AHIP adds,
    • “Hospital spending makes up the largest share (40%) of health insurance premiums and continues to grow, now exceeding $1.6 trillion annually. One major driver of high hospital costs is that routine services are often reimbursed at substantially higher prices — sometimes up to 13 times more — in hospital outpatient departments (HOPDs) than in physician offices and other non-facility settings, even though the care is the same.” 
  • Beckers ASC Review tells us,
    • “Physician assistants and advanced practice registered nurses can now order every noninvasive colorectal cancer screening test Medicare covers, ending a long-standing physician-only requirement under a CMS coverage change.
    • “CMS authorized the expanded coverage in June when it finalized a decision memo revising the “Screening for Colorectal Cancer — Non-Invasive Biomarker Tests” national coverage determination, the American Academy of Physician Associates said in a Sept. 10 news release.
    • “The determination previously covered the tests only when a physician ordered them. CMS reopened it after new evidence emerged on stool-based RNA tests.
    • “PAs and APRNs may now order RNA-based stool tests, DNA-based stool tests, DNA-based blood tests and fecal occult blood tests.”
  • Beckers Hospital Review informs us,
    • “Johnson & Johnson will require 340B covered entities to submit claims-level data for its covered outpatient drugs starting Sept. 15, according to a notice the drugmaker sent to providers Sept. 4.
    • “Covered entities that don’t submit will receive at least two noncompliance notices and a notice of pricing suspension, with suspension beginning at least five business days after the final notice. J&J said 340B pricing will be restored within 10 business days once a covered entity submits compliant data.
    • “The policy applies to all covered entity types regardless of dispensing or administration location, inventory management system or payer coverage. J&J said it will continue to offer 340B pricing upfront at the time of purchase rather than moving to a rebate model, and that the policy supersedes claims-data provisions in a prior notice from February 2023.
    • “Covered entities must submit data within 45 days of a drug’s dispensation; a list of oncology, autoimmune and other specialty drugs, including Stelara, Darzalex and Tremfya, carries a 60-day window.” 

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

  • Federal New Network offers an interview with OPM Director Scott Kupor, and further reports
    • “Federal employees’ performance ratings will now be the top consideration during future reductions in force, as a final rule from the Office of Personnel Management takes full force this month.
    • “OPM’s final regulations, which became effective Sept. 2, mark a significant turning point in the way agencies develop RIF retention registers, which determine whether employees are retained, reassigned, demoted or separated during RIFs.
    • “Following the publication of the final rule in August, OPM detailed further expectations about the new system in guidance to agencies. During any future RIFs, agencies will have to rank employees using a point system directly tied to their performance ratings. An employee with a level 5 performance rating will receive seven points on the RIF register, while level 4 receives five points; level 3 receives three points; and levels 1 and 2 each receive zero points.
    • “Agencies will also place competitive service and excepted service employees on separate retention registers in any future RIFs. Within each list, employees will then be numerically ranked based on their performance levels, with points added for veterans’ preference. Tenure and seniority will be used only as tiebreakers between employees.”

From the Food and Drug Administration front,

  • The Pharmacy Times reports,
    • “The FDA approved leniolisib (Joenja; Pharming Healthcare) tablets for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 to 11 years who weigh at least 27 kg. The decision makes leniolisib the first FDA-approved treatment for children in this age and weight group with the rare genetic immune disorder.”
  • Cardiovascular Business relates,
    • “Emboline, a California-based medtech company, has received U.S. Food and Drug Administration (FDA) approval for its Emboliner Embolic Protection System. The device was built to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) procedures. This is seen as a way to reduce the risk of stroke, which clinicians have been battling since TAVR was first introduced, as well as other potential complications.
    • “We developed the Emboliner to address important unmet needs with existing embolic protection approaches for TAVR,” Scott Russell, president and CEO of Emboline, said in a statement. “We are excited to now be able to put the Emboliner in the hands of physicians so that they can offer a more comprehensive embolic protection solution for their patients. We are grateful to the clinical investigators whose partnership and feedback helped us reach this point.”
    • “The Emboliner device includes a self-expanding filter that covers all three cerebral vessels. The filter’s double-layer mesh captures debris without restricting blood flow in any way.
    • “Emboline plans on beginning its commercial launch of the newly approved device by the end of 2026.”
  • Fierce Pharma tells us,
    • “The FDA has delayed its approval decision for Exelixis’ oral kinase inhibitor zanzalintinib in combination with Roche’s Tecentriq for the treatment of patients with metastatic colorectal cancer (mCRC). 
    • “Exelixis explained in a Securities and Exchange Commission filing that the agency has asked for the extension while it awaits updated safety and efficacy data from the company. It means the biopharma should now expect a decision in March 2027 as opposed to the previous deadline of Dec. 3, 2026.”

No Surprises Act News

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury have added Physio Solutions, LLC as a new independent dispute resolution entity increasing the total to 17. IDR arbitrators help make payment determinations in disputes between providers, group health plans and health insurance issuers under the No Surprises Act.”
  • Beckers Payer Issues summarizes five other recent NSA updates for us.

From the judicial front,

  • Bloomberg Law reports,
    • “A federal judge blocked the Trump administration’s use of a question for federal job applicants that critics said amounted to a test of their political beliefs. 
    • “The Trump administration can no longer require thousands of government job seekers to say why the president’s policies are personally significant to them, and how they would further them if hired, according to a Friday ruling in the US District Court for the District of Massachusetts.” * * *
    • “While the ruling prevents the administration from using the question on job applications, O’Toole denied the unions’ request for a broader preliminary injunction barring the government from incorporating applicants’ answers or non-answers into hiring decisions. 
    • The case is AFGE v. Kupor, Office of Personnel Management, D. Mass., 25-13305-GAO, 9/11/26

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 11, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP adds,
    • “The number of confirmed US cases of measles has reached 3,294, fully 1,000 more than all of last year, the Centers for Disease Control and Prevention (CDC) noted in its weekly update today. 
    • “The total includes 160 new cases, most of them in Pennsylvania, the nation’s measles hot spot. The country has now seen five straight weeks of triple-digit increases.”* * *
    • “As noted in the data from the CDC map, cases in Wisconsin are also ramping up. In an update today, the Wisconsin Department of Health Services (DHS) confirmed 163 cases across the state so far this year. Four cases are new since September 8.” * * *
    • “Ohio this week confirmed 11 new cases, 133 total. In good news, Utah, which was a measles hot spot earlier this year, has gone more than three weeks without a confirmed case. Its case count stands at 518.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention Sept. 10 released an advisory on a nationwide increase of reported human exposures to rabid or possibly rabid animals and rabies post-exposure prophylaxis administration errors. The CDC said it received 17% more rabies-related inquiries from July through August this year — including reports of mass exposure events — compared to the same period in 2025. The agency said that weekly pharmacy data as of Sept. 2 showed that utilization for the two rabies vaccines and two rabies immunoglobulins licensed in the U.S. increased by an estimated 33% and 76%, respectively, compared with the same period last year. The advisory includes recommendations for clinicians and healthcare facilities on rabies treatment and appropriate rabies PEP assessment and administration.”
  • The Wall Street Journal informs us,
    • “Public-health officials declared an end to a cyclosporiasis outbreak linked to iceberg lettuce that spread across the U.S. this summer.
    • “The outbreak has resulted in a total of 12,883 reported cases of the gastrointestinal food-borne illness across 21 states, the Centers for Disease Control and Prevention said Friday.
    • “Federal health officials have linked the outbreak to shredded iceberg lettuce from Taylor Farms, a major supplier of fresh produce to retailers such as Walmart, Costco Wholesale and Amazon.com’s Whole Foods Market, as well as restaurant chains including McDonald’s and Yum Brands’ Taco Bell.
    • “The CDC said the contaminated lettuce linked to the outbreak is no longer available in stores or restaurants, and the products’ best-by dates have passed. Recent infections linked to the outbreak have declined, with fewer than two infections per day on average in August compared to a peak of more than 1,000 daily infections, the CDC said.”
  • Health Day points out,
    • “Talking to a counselor before major surgery might boost seniors’ recovery following a procedure, a new study says.
    • “Mental health coaching before surgery can help reduce seniors’ risk of post-surgery anxiety and depression, researchers reported Sept. 9 in JAMA Network Open.
    • “The time around surgery is a window of both risk and opportunity,” lead researcher Joanna Abraham said in a news release.
    • “The stress of surgery can worsen anxiety and depression symptoms and affect patients’ recovery and overall health, but it also offers a critical opportunity to identify these concerns proactively and connect patients with the support they need,” said Abraham, a professor of anesthesiology at Washington University School of Medicine in St. Louis.”
  • Nature notes,
    • “Injected vaccines can raise an army of antibodies in the blood to stave off major illness, but don’t prevent infection at the points where respiratory viruses enter the body. Researchers hope that nasal vaccines could bolster protection at the moist mucosal barriers that line the respiratory tract, which could enable a person to rapidly ward off pathogens and prevent them from spreading a virus to others. A long line of failures demonstrates that developing a mucosal vaccine is a challenging task, but their promise is still enough to maintain commercial interest.”
  • Per Beckers Clinical Leadership,
    • “The rise of GLP-1 medications is one of the most consequential changes in obesity care in decades. Not surprisingly, bariatric surgery is feeling the impact. As patients gain access to powerful medications such as semaglutide and tirzepatide, fewer are immediately choosing an operation. The trend is real, but [as explained in the article,] the conclusion that GLP-1s will simply replace bariatric surgery misses the larger story.”

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

  • Beckers Hospital Review reports,
    • “Septicemia is the most expensive condition treated in hospitals, amounting to $60 billion in annual costs, a Healthcare Cost and Utilization Project report found. 
    • “The report, published February 2026, used 2022 data from the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project on hospital costs of inpatient stays in nonfederal acute care hospitals. Using the 2022 HCUP National Inpatient Sample, the report found the distribution of costs by primary expected payer and the conditions that accounted for the largest percentage of payer’s hospital costs. Hospital charges were converted to costs using HCUP cost-to-charge ratios. Payers included Medicare, Medicaid, private insurance and self-pay/no charge. 
    • “The report found: 
      • “The aggregate hospital costs for 32.9 million hospital stays totaled $548.5 billion.
      • “The 20 most expensive conditions account for 46.8% of aggregate hospital costs in 2022, and amounted to 43.1% of all hospital stays.
      • “Septicemia accounted for 10.9% of aggregate costs for all hospital stays in 2022 across all payer groups — more than three times higher than the next most expensive condition: liveborn infants which accounted for 3.6% of aggregate costs.
      • “Among the most expensive conditions, liveborn infants were the most common reason for hospitalization at 10.6% of all hospital stays, followed by septicemia at 7.4%, heart failure at 3.3% and COVID-19 at 2.5%.
      • “Circulatory system conditions were the most frequent of the top 20 diagnoses for Medicare, private insurance or self-pay/no charge.
      • “Pregnancy and childbirth conditions were the most frequent among the top 20 conditions for Medicaid.”
  • and
    • “More than 150 independent rural hospitals across eight states have banded together into clinically integrated networks over the past three years, betting that shared scale, data and negotiating leverage can keep them out of the arms of consolidating systems and payers.
    • “The newest addition is the Show-Me High Value Network, a Missouri coalition of 23 independent hospitals that collectively serve more than 1.8 million residents across urban, rural and underserved communities. It joins a fast-growing map of rural high-value networks that includes: 
    • “Cibolo Health, a Texas-based consultancy that specializes in building rural hospital collaboratives, manages seven of the networks, including those in North Dakota, Minnesota, Ohio, Montana, Nebraska, Wisconsin and Kansas.”
  • and
    • “St. Louis-based Mercy recorded an operating income of $500.8 million (4.5% margin) for fiscal year 2026, up from $21.4 million (0.2% margin) in fiscal 2025, according to its Sept. 11 financial report.”
  • and
    • “Hershey, Pa.-based Penn State Health reported a $131.2 million operating gain on $5 billion in revenue for the fiscal year ended June 30, a significant improvement from the prior year, according to its audited financial statements.”
  • Beckers Payer Issues relates,
    • “Ujjwal Ratan has joined UnitedHealth Group’s consulting and analytics division, Optum Insight, as chief AI officer.
    • “In a Sept. 10 LinkedIn post, Mr. Ratan said his role is to enable Optum Insight to operate as a connected agentic network in healthcare.”
  • and
    • “Taft Parsons III, MD, is leaving his role as CVS Health’s chief psychiatric officer.
    • “Executives decide to try something different, and organizational structures and jobs change,” he said Sept. 11 on LinkedIn. “I’ve benefited from those changes more often than not, and I understand this is simply my turn to find another path toward improving healthcare.”
  • Beckers ASC Review tells us,
    • “National Healthcare Properties completed the sale of 30 primarily multi-tenant outpatient medical facilities for $198 million.
    • “The transaction represents the first tranche of its previously announced sale of 86 outpatient medical facilities for approximately $528 million, according to a Sept. 10 news release from the company. The remaining 56 facilities are expected to close in the fourth quarter of 2026.”
  • The Wall Street Journal points out,
    • “France’s Ipsen IPN is considering building a production site in the U.S., joining other European drugmakers looking across the pond when planning new investments.
    • “Discussions are ongoing,” Ipsen Chief Executive David Loew said in an interview. “No decision has been reached yet on exactly when, but this is certainly something that we are taking into consideration.”
    • “Loew said the next big plant the company builds will manufacture either its Dysport drug—a rival to AbbVie’s ABBV Botox—or a next-generation medicine called corabotase that is still under development.
    • “Many of the world’s top pharmaceutical companies pledged to make multibillion-dollar investments to bring manufacturing and other operations to the U.S. over the coming years, in a bid to mitigate tariff threats by the Trump administration. In addition to big companies like AstraZeneca and Roche, smaller drugmakers like Belgium’s UCB and Australia’s CSL also plan to invest in new U.S. facilities.”
  • Fierce Pharma lets us know,
    • “Both Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo saw their highest total prescriptions so far over the past week as the companies’ oral obesity battle continues to play out.  
    • “According to IQVIA data cited by Citi, the Wegovy pill reached an approximate 183K total scripts for the most recent reporting period, versus 181K the week prior. Foundayo, for its part, climbed nearly 8% to reach 47.5K scripts. Citi analysts emphasized that IQVIA may still be missing some Foundayo prescriptions made through telehealth channels. 
    • “Meanwhile, using the last four weeks as a guide, total GLP-1 prescriptions have increased by 5.4%, compared to a 6.8% decline the prior year, the Citi team said. Citi analysts attributed the 12-percentage-point swing to the expansion of oral GLP-1 therapies, which is likely broadening access to the class and drawing in new patients.  
    • “Across the broader landscape, Lilly’s tirzepatide currently holds a nearly 57% share of the total GLP-1 market, compared to around 49.5% last year, while Novo’s semaglutide has stayed relatively flat at a 37% share, the analysts added.”  

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.

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Midweek report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the fraud, waste and abuse front,

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

No Surprises Act News

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

From the public health and medical / Rx research front,

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

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

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

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Weekend update

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

Simplicity is a virtue.

From Washington, DC

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

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

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

From the public health and medical / Rx research front

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

From the U.S. healthcare business front,

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

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.”