Friday report

U.S. Healthcare

Friday report

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Here is a link to OPM Director Scott Kupor’s latest blog post which is titled “Supporting Agencies through Change.” Thanks, Director Kupor for keeping us abreast of your activities.
  • The Wall Street Journal reports,
    • “President Trump removed former congressman Billy Long as the commissioner of the Internal Revenue Service after less than two months in the job.
    • “Long is being replaced on an interim basis by Treasury Secretary Scott Bessent, a senior White House official said. Bessent is the latest leader of a federal bureau that has gone through a series of commissioners since the start of Trump’s second term. Long was sworn in as the commissioner in June. 
    • “Long said Trump is appointing him as ambassador to Iceland.” 
  • The American Hospital Association News tells us,
    • “President Trump Aug. 7 issued an executive order, “Improving Oversight of Federal Grantmaking,” requiring government agencies to review new and discretionary grants to ensure grant funding advances the administration’s policy priorities. Among other provisions, the order restricts agencies from funding programs that “fund, promote, encourage, or facilitate: (A) racial preferences or other forms of racial discrimination … (B) denial by the grant recipient of the sex binary in humans … (C) illegal immigration; or (D) any other initiatives that compromise public safety or promote anti-American values.” The executive order also encourages agencies to award grants to institutions with lower indirect cost rates, to a broad range of recipients rather than repeat players, and to include clear benchmarks for measuring progress and success, as well as a commitment to Gold Standard Science. Within 30 days, agencies will update the terms and conditions for new and existing discretionary grants, which may permit immediate termination of existing grants.”
  • and
    • “The U.S. Departments of Labor, Health and Human Services, and the Treasury announced Aug. 7 that they are reconsidering the definition of short-term, limited-duration insurance through a formal rulemaking process. Until new rules are finalized, the departments will not prioritize enforcement actions against insurers that do not fully comply with the 2024 definition, including related notice requirements.
    • “HHS encourages states to adopt a similar enforcement approach and will not penalize states that either follow this federal approach or apply their definitions of STLDI under state law.”
  • STAT News informs us,
    • “Federal health officials are citing an extensive list of studies purported to document harms caused by messenger RNA vaccines as scientific justification for canceling hundreds of millions of dollars in investment in the technology. 
    • “Health secretary Robert F. Kennedy Jr. provided only a brief explanation for the decision earlier this week, arguing the mRNA vaccines are not effective and not as safe as alternatives, and referencing a review of scientific research on mRNA by “experts,” without identifying them. On Friday, when asked if the Department of Health and Human Services had a scientific justification, a spokesperson provided a link to a 181-page list of studies compiled by a number of people, including a current Trump administration adviser who served in the president’s first administration and was the subject of controversy for pushing unproven Covid-19 treatments. 
    • “The other contributors are people who have all previously criticized Covid-19 public health interventions, such as lockdowns and mRNA vaccines. 
    • “Taken together, the studies cited generally appear to advance research that has been disputed by other scientists, who argue that mRNA vaccines are overwhelmingly safe.”

From the Food and Drug Administration front,

  • MedPage Today relates,
    • “The FDA on Friday granted accelerated approval to zongertinib (Hernexeos) for non-squamous non-small cell lung cancer (NSCLC) patients harboring HER2 tyrosine kinase domain (TKD) activating mutations.
    • “Approval of the tyrosine kinase inhibitor stipulates use in adults with unresectable or metastatic disease who have received prior systemic therapy and was based on results from the open-label, phase Ia/Ib Beamion LUNG-1 study.”
  • Fierce Pharma adds,
    • “After telegraphing an investigation in November, the FDA has moved to restrict the use of bluebird bio’s gene therapy Skysona in certain patients.
    • “The FDA has updated Skysona’s indication, allowing it to be used only in patients who do not have an available human leukocyte antigen (HLA)-matched donor for stem cell transplant. The one-time therapy is approved to treat cerebral adrenoleukodystrophy (CALD), a rare inherited neurological disorder in which the accumulation of harmful fatty acids in the bloodstream damages the protective myelin sheath around nerve fibers.
    • “The FDA decided that Skysona should not be used in patients with alternative treatment options due to concerns of an increased risk of blood cancer.” * * *
    • “Skysona, with a list price of $3 million per treatment, recorded no sales in the first three months of 2025. Beta-thalassemia therapy Zynteglo saw its sales rise to $26.3 million during the first quarter, compared with $18.6 million a year ago. The sickle cell disease gene therapy Lyfgenia brought in $12.4 million in sales during the period, while Vertex’s rival CRISPR-based treatment Casgevy pulled in $14.2 million.” * * *
    • “As commercial progress of the three gene therapies fails to impress and a debt payment nears its due date, bluebird bio recently sold itself to Carlyle and SK Capital Partners for $49 million, or $5 per share, following some investor resistance to a previous lower offer price.”
  • Per an FDA news release,
    • “I [FDA Commissioner Marty Makary] am pleased to announce that the nationwide shortage of sodium chloride 0.9% injection products, a form of intravenous (IV) saline, has officially ended. This marks a significant milestone for public health and reinforces the FDA’s commitment to ensuring Americans have consistent access to life-saving medical products.” * * *
    • “For other IV fluids still in shortage, the FDA is working closely with manufacturers and will continue to monitor the supply to help ensure patients have access to the medicines they need. The availability of reliable medical products is essential to patient care and the overall resilience of our healthcare system. Addressing this shortage has been a top priority for the FDA and aligns with the Trump Administration’s broader commitment to strengthening the U.S. drug and medical supply chain.”
  • MedTech Dive lets us know,
    • “Boston Scientific has updated the instructions for use for products deployed in the implantation of its Watchman heart device to reduce a risk associated with 120 serious injuries and 17 deaths.
    • “The Food and Drug Administration released an early alert about the update Wednesday. Sharing information from Boston Scientific, the FDA said implanting the heart device without controlling the patient’s breathing increases the risk of an air bubble getting into the vascular system.
    • “Patients are only at risk during the implant procedure. People who have a previously implanted Watchman device do not need additional management.”

From the judicial front,

  • The Wall Street Journal reports,
    • “[The prescription drug manufacturer] GSK will receive $370 million from a U.S. patent settlement between CureVac and BioNTech regarding mRNA-based Covid-19 vaccines.
    • “GSK will get an upfront cash payment of $320 million and a 1% royalty on future U.S. sales of related mRNA vaccine products.
    • “The settlement does not affect GSK’s ongoing patent litigation against Pfizer and BioNTech in the U.S. or Europe.”
  • Healthcare Dive reports,
    • “Healthcare bankruptcies dropped to a three-year low during the second quarter of 2025, according to a new report from Gibbins Advisors. Just seven companies with at least $10 million in liabilities filed for Chapter 11 protections, compared with 14 in the same period last year.
    • “The restructuring advisory firm predicts there will be 16% fewer filings this year compared to 2024, as less large healthcare companies and providers declare bankruptcy.
    • “However, the dip may be short lived. Challenging market conditions, including impacts from cuts to Medicaid, could hit providers’ bottom lines as early as 2026, potentially spurring a new wave of bankruptcies, according to Gibbins.”

From the public health and medical research front,

  • The JAMA Network reports,
    • “Although the average life expectancy in the US remains lower than before the COVID-19 pandemic, 2023 marked the second consecutive year of improvement, according to a new report from the US Centers for Disease Control and Prevention (CDC). The authors attributed increases in life expectancy across all groups to decreased mortality from COVID-19, heart disease, unintentional injury, cancer, and diabetes.
    • “The overall average life expectancy rose by almost a year between 2022 and 2023, from 77.5 years to 78.4 years. During this period, male life expectancy increased from 74.8 to 75.8, whereas female life expectancy increased from 80.2 to 81.1. The average female life expectancy has exceeded that of males for decades, but the size of this gap continues to fluctuate.
    • “When analyzed by race and ethnicity, life expectancy increased for all populations in 2023. The American Indian and Alaska Native population experienced the greatest jump in mean life expectancy, a 2.3-year rise from 67.8 to 70.1.”
  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota CIDRAP adds,
    • “Amid a slow but steady rise in COVID activity, SARS-CoV-2 wastewater detections last week rose from the low to the moderate level, with the highest levels in the West, followed by the South, where detections in Louisiana are at the very high level, the US Centers for Disease Control and Prevention (CDC) said today in its latest weekly data updates. 
  • and
    • “Today in JAMA Network Open, University of Michigan-led research suggests that the US 2023-24 mRNA COVID-19 vaccines were cost-effective for people older than 65 years and in certain situations for younger adults.” * * *
  • and
    • “A survey conducted in emergency departments (EDs) in eight US cities found that 86% of adult respondents were not up to date with recommended vaccines, and half had not even heard of one or more of these vaccines.
    • “But the results of the survey, conducted by a team of US researchers and published yesterday in Morbidity and Mortality Weekly Report, also found that nearly half of the respondents said they would be willing to get a missing shot if they were offered one during their ED visit, and most of those participants said they’d be willing to get all of their missing vaccines.
    • “The authors of the study say the findings indicate that screening for vaccine coverage in EDs, which millions of Americans rely on as their only source of healthcare, could help boost recommended vaccine uptake in populations that have no primary care provider, such as immigrants, the uninsured, and homeless people.”
  • Per JAMA Network,
    • “The tau protein is known to be ubiquitous in neurons. Its naturally unfolded and highly flexible character allows it to interact with many components in neurons, especially microtubules in axons, helping to give these elements structure and promote growth. But when tau undergoes certain abnormal biochemical modifications such as phosphorylation, the pliable protein can lose function and can misfold and aggregate, leading to the development of neurofibrillary tangles and contributing to neurodegeneration. That’s why high levels of phosphorylated tau (p-tau) serve as one of the two main fluid biomarkers for Alzheimer disease (AD)—and why it surprised researchers when they recently discovered that infants have levels of p-tau far higher than people with AD.
    • “I was used to just hearing ‘p-tau is Alzheimer disease,’” said Fernando Gonzalez-Ortiz, MD, PhD, of the University of Gothenburg in Sweden who published the recent findings with a team of international collaborators. “In the Alzheimer disease field, we are sometimes very focused on thinking that p-tau is one of the bad guys, like tau phosphorylation is a completely pathological process, but that is not the case.”
    • “Using blood samples from umbilical cords and data from the Norwegian Dementia Disease Initiation cohort, Gonzalez-Ortiz and his colleagues found that healthy newborns had serum concentrations of p-tau217, an AD biomarker, around 10 pg/mL, nearly 3 times higher than those measured in patients with AD.
    • “The observation, which appeared this June in Brain Communications, led Gonzalez-Ortiz to a question: “What does it mean that the baby can handle these high concentrations of p-tau, but the adult brain can’t?” * * *
    • “Maybe in the future, therapies that target the clearance mechanisms and then enhance clearance, in combination with antiamyloid therapies, might lead to not only getting rid of amyloid, but also to preventing aggregation of tau,” Gonzalez-Ortiz said.
    • “His team’s next step is to differentiate the forms of p-tau present in the infant samples. Villain noted that it could also be useful to test the ratio between p-tau and total tau in the specimens to understand whether infants simply have more tau in their bloodstream.”
  • The University of Minnesota CIDRAP relates,
    • “A study of adults hospitalized with community-acquired pneumonia (CAP) in Georgia and Tennessee shows that a sizable fraction of infections was caused by Streptococcus pneumoniae, including serotypes covered by recently approved vaccines, researchers reported yesterday in JAMA Network Open.
    • “The prospective active-surveillance study, led by researchers at Vanderbilt University Medical Center, analyzed data on patients with clinical and radiologic evidence of CAP at three hospitals in Georgia and Tennessee from 2018 through 2022.” * * *
    • “The authors note that the annual incidence of 43 hospitalizations per 100,000 adults extrapolates to 114,800 US hospitalizations for pneumococcal CAP each year, based on current population estimates.
    • “Results of this study demonstrate that pneumococcal CAP remains an important cause of hospitalizations in the US,” they wrote. “With vaccination as the primary preventive measure for pneumococcal pneumonia, improved pneumococcal vaccines with appropriate vaccination coverage could lessen the burden of severe pneumonia on the US population, especially among older adults.” 
  • The Wall Street Journal reports,
    • “With a 33-year high in U.S. measles cases, researchers are reviving the search for treatments because of falling vaccination rates.
    • “Biotechs and universities are developing drugs for vulnerable, unvaccinated people.
    • “Monoclonal antibodies could offer immediate immunity, benefiting newborns, the immunocompromised and vaccine skeptics, scientists say.”
  • Per Health Day,
    • “Automatically mailing a stool test kit to people’s homes might be the best way to boost colon cancer screening among younger adults, a new study says.
    • “More 45- to 49-year-olds went ahead with cancer screening when they received an unsolicited stool test kit in the mail, rather than having to actively opt into screening or choose a test, researchers reported Aug. 4 in the Journal of the American Medical Association.
    • “Removing the need for patients to actively opt into screening can lead to better outcomes, particularly when trying to engage younger, generally healthy adults who may not yet perceive themselves at risk for cancer,” senior researcher Dr. Folasade May said in a news release. She’s a gastroenterologist and cancer prevention researcher at the UCLA Health Jonsson Comprehensive Cancer Center.”

From the U.S. healthcare business front,

  • Modern Healthcare interviews Debra Sukin, president and CEO of Texas Children’s, about the impressive financial turnaround at Texas Children’s, the largest pediatric hospital system in the U.S.
    • “How did you make a turnaround happen?
      • “We set out to best address the redesign of our organizational structure and realign the leadership team. We began to chart a course, entity by entity, department by department, in terms of how we were going to achieve our strategic goals.
      • “I’m a very data-driven leader. Organizing the way that we look at data, share data and use data to make decisions became absolutely paramount. We could easily see all our respective entities and where there were opportunities for improvements, and most importantly, identify how we were going to look beyond just expense management. 
      • “It was also about growth. It was about homing in on those opportunities and treating additional patients who needed our care.” 
  • Fierce Healthcare adds,
    • “Ascension [Healthcare, another large health system,] is taking a more intentional approach to innovations with a new unit dedicated to exploring, vetting and deploying tech tools across the major nonprofit health system.
    • “The organization announced this week the launch of its Clinical Innovation Institute (CII), which Ascension Chief Clinical Officer Thomas Aloia, M.D., describes as an “umbrella” aggregating and presiding over other innovation and tech programs that were already active within Ascension.
    • “We are absolutely not starting from scratch,” he said. “I would say we’re driving at about 60 miles per hour, and this organizational backing and support is going to take us to drive even faster.”
  • Healthcare Dive lets us know,
    • “Community Health Systems has found a new buyer for its three-hospital portfolio in Pennsylvania, approximately nine months after a proposed sale of the same facilities to WoodBridge Healthcare collapsed.
    • “Hospital turnaround firm Tenor Health Foundation signed a letter of intent to acquire Regional Hospital of Scranton, Moses Taylor Hospital and Wilkes-Barre General Hospital, collectively Commonwealth Health System, last week, a CHS spokesperson told Healthcare Dive. 
    • “The hospitals have been hemorrhaging money in recent fiscal years, according to reports filed to the Pennsylvania Health Care Cost Containment Council. Lawmakers have previously expressed worry that CHS could close the facilities if they could not find a buyer, reducing patients’ access to care.” 
  • Per Fierce Healthcare,
    • “In its first public earnings call after its initial public offering in June, virtual chronic disease provider Omada Health reported $61 million in revenue, up 49% year over year. The company has added 52% more members since Q2 2024 for a total of 752,000 members.
    • “Omada went public in early June, at a valuation of $1.1 billion, during what has turned out to be a worse-than-expected year for digital health exits due to economic uncertainty and tariffs. Hinge Health, a virtual MSK solution, also went public in May and reported its Q2 earnings on Wednesday.
    • “Omada ties remote monitoring devices with coaching and AI to help consumers control their chronic diseases. The company treats diabetes, hypertension, obesity and musculoskeletal conditions and leans on its multi-condition approach to differentiate itself from competitors.” 

Thursday report

David Ermer–CDC, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • MedPage Today tells us,
    • “HHS Secretary Robert F. Kennedy Jr. last month quietly endorsed recommendations from his handpicked vaccine advisors that everyone in the U.S. ages 6 months and older receive a flu shot for the upcoming season.” * * *
    • “ACIP reaffirms the recommendations for routine annual influenza vaccination of all persons aged ≥6 months who do not have contraindications for the 2025-2026 season,” the ACIP page states. “With no current CDC Director and pending confirmation of a new CDC Director, this recommendation was adopted by the HHS Secretary on July 22, 2025, and is now an official recommendation of the CDC.”
    • “A new CDC director, Susan Monarez, PhD, is now in place. * * *
    • “Another ACIP recommendation from the June meeting earned an endorsement Aug. 4 from Monarez. ACIP called for infants younger than 8 months who were born during or entering their first respiratory syncytial virus (RSV) season who are not protected by maternal vaccination to receive one dose of clesrovimab (Enflonsia)opens in a new tab or window. The monoclonal antibody joins a similar long-acting shot, nirsevimab (Beyfortus),opens in a new tab or window as an option for this population.”
  • Beckers Hospital Reviews lets us know six things about the tariffs that took effect today.
  • Federal News Network informs us,
    • “The Postal Service’s board of governors is urging its regulator not to put limits on its ability to set higher mail prices, after posting another multibillion-dollar quarterly net loss.
    • “USPS posted a $3.1 billion net loss for the third quarter of fiscal 2025 — a greater loss than the $2.5 billion net loss it saw for the same period last year.
    • “But Postmaster General David Steiner said USPS is “on the right path,” under a 10-year reform plan launched by his predecessor, former Postmaster General Louis DeJoy.
    • “The strategy is sound. Now we have to execute,” Steiner said during a public meeting of the USPS Board of Governors on Thursday. “But we can’t execute unless all of our team is working together. We all need to be rowing the oars in the same direction.”
  • Healthcare Dive relates,
    • “Amwell has extended a contract with the Defense Health Agency to support virtual care at the military health system, one of the company’s most significant growth initiatives, for another year, the telehealth vendor said Tuesday. 
    • “However, the deal cut out deployments for Amwell’s behavioral health and automated care programs “due to budget restrictions being broadly enforced by the Department of Defense,” CEO Ido Schoenberg said during a second quarter earnings call on Tuesday. 
    • “The contract change led the telehealth firm to revise its guidance for 2025. Amwell now expects revenue from $245 million to $250 million this year, down from its previous outlook of $250 million to $260 million.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration Aug. 7 announced a new program to help improve the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of drug manufacturing facilities in the U.S. The program, called FDA PreCheck, was created in response to a May 5 executive order, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs the FDA to streamline and accelerate the development of domestic pharmaceutical manufacturing by eliminating unnecessary or duplicative regulations and improving inspection processes. 
    • “The program consists of a two-phase approach to facilitate new manufacturing facilities. The first provides manufacturers with more frequent FDA communication during stages such as facility design, construction and pre-production. The second focuses on streamlining development of the chemistry, manufacturing and controls section of the drug application through pre-application meetings and early feedback.” 
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Thursday lifted its recommendation to pause use of Valenva’s chikungunya vaccine Ixchiq in older adults but added new warnings about the shot’s risks and limited who is eligible to receive it.
    • “The FDA’s action follows a similar move by the European Medicines Agency, which had paused use along similar lines as the FDA. However, the U.S. regulator’s changes to Ixchiq’s labeling appear likely to curtail how broadly its used in the future.
    • “Vaccination with Ixchiq is not advisable for most U.S. travelers. For most U.S. travelers, the risk of exposure to chikungunya is low,” the updated label says.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care flagged a problem with certain t:slim X2 insulin pumps where a wiring issue with certain devices’ speakers can cause them to malfunction and stop delivering insulin. 
    • “Tandem said it has received reports of 700 adverse events and 59 injuries. There have been no reports of death. The problem, if not addressed, presents the risk of hyperglycemia in people with diabetes. The company said in a Thursday announcement that it has also alerted the Food and Drug Administration and regulators outside of the U.S. 
    • “The company sent a letter to customers in July. The FDA has not yet posted the device correction in its recall database.”
  • Fierce Pharma adds,
    • “When Jazz Pharmaceuticals’ incoming CEO Renee Gala takes the reins at the drugmaker next week, she’ll have a brand-new launch to manage.
    • “Wednesday, the FDA approved Jazz’s Modeyso (dordaviprone) for patients ages 1 and older with H3 K27M-mutant diffuse midline glioma who have progressive disease following prior therapy. The drug, picked up in the company’s $935 million buyout of Chimerix earlier this year, is the first systemic therapy for those with the aggressive brain cancer.”

From the judicial front,

  • Healthcare Dive reports,
    • “UnitedHealth and Amedisys have agreed to a settlement with the Department of Justice, clearing the path for their $3.3 billion merger to go through.
    • “The settlement, filed with the Maryland district court on Thursday, requires UnitedHealth and Amedisys to divest certain businesses in order to placate the DOJ’s concerns that the merger is anticompetitive. Amedisys has also agreed to pay a $1.1 million civil penalty to the U.S. for not fully complying with regulators during the merger review process.
    • “Regulators’ tentative greenlight of the multibillion-dollar deal is a win for UnitedHealth, which originally proposed plans to acquire the home health and hospice provider in 2023. However, the merger has been tied up in litigation after the DOJ and four states sued to block it in November.”
  • Per Fierce Healthcare,
    • “The drug price negotiation program has withstood another procedural effort in striking down one of the Inflation Reduction Act’s most significant provisions.
    • “In the U.S. Court of Appeals for the 6th Circuit, a panel of judges upheld (PDF) a lower court’s decision to dismiss the lawsuit.
    • “A judge dismissed the lawsuit last year, saying most of the plaintiffs lacked standing to bring the case, but the U.S. Chamber of Commerce was able to file a new suit. The U.S. Chamber could now appeal to the Supreme Court, reported The Hill.”
  • The Hill adds,
    • “Federal judges in Texas and Connecticut on Thursday ruled against arguments challenging the constitutionality of the Medicare Drug Price Negotiation Program, delivering two more blows to the pharmaceutical industry this week after an appeals court upheld the dismissal of a similar case.
    • “In Connecticut, the U.S. 2nd Circuit Court of Appeals upheld (PDF) a decision granted by U.S. District Judge Michael P. Shea last year against pharmaceutical company Boehringer Ingelheim. The company’s diabetes medication Jardiance was among the first 10 drugs chosen for Medicare negotiations, and two more of its products were chosen for the following round of negotiations.”
    • “In Texas, U.S. District Judge David Alan Ezra dismissed the lawsuit brought forward by the trade group PhRMA with prejudice, closing the case.”

From the public health and medical research,

  • The Wall Street Journal reports,
    • “Ultraprocessed foods make up the majority of calories Americans are eating, according to a report released Thursday by the federal government. But there are signs this consumption might be declining.
    • “Sandwiches, baked goods, salty snacks and other ultraprocessed foods accounted for 55% of the calories Americans age 1 and older consumed from August 2021 to August 2023, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics study. 
    • “That proportion is getting smaller. For adults, the mean percentage of calories consumed from ultraprocessed foods fell 3 percentage points to 53% since 2018 and for children and teens, it fell nearly 4 percentage points to 61.9%, the report found.
    • “Statistically, the decline is significant,” said Anne Williams, a senior service fellow at the CDC and lead author of the report. For adults consuming around 2,000 calories a day, the drop between the 2017 to 2018 figures and the latest report translates to around 60 fewer calories a day coming from ultraprocessed foods on average, said Williams.
    • “Ultraprocessed foods have been linked to an array of health issues, including obesity, Type 2 diabetes, cancer, cardiovascular disease and depression. There isn’t a set definition for ultraprocessed foods but researchers consider them foods made with ingredients not normally found in a home kitchen, including high-fructose corn syrup and emulsifiers such as soy lecithin.”
  • MedPage Today adds,
    • “Eating French fries multiple times a week was associated with a higher risk of type 2 diabetes, though this wasn’t the case for baked, boiled, or mashed potatoes, researchers said.
    • “For every increment of three servings weekly of French fries, the rate of type 2 diabetes increased by 20% (95% CI 1.12-1.28), and for every increment of three servings weekly of total potato, the rate increased by 5% (95% CI 1.02-1.08), reported Walter Willett, MD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues.
    • “However, consumption of combined baked, boiled, or mashed potatoes was not significantly associated with risk of type 2 diabetes (pooled HR 1.01, 95% CI 0.98-1.05), they noted in The BMJ.
    • “Importantly, our substitution analysis showed that replacing all forms of potatoes — especially fries — with whole grains was linked to a lower risk of type 2 diabetes, whereas swapping them for white rice was associated with the opposite effect,” co-author Seyed Mohammad Mousavi, PhD, also of the Harvard T.H. Chan School of Public Health, told MedPage Today. “This reinforces that it’s not just about the potato itself, it’s about how it’s prepared and what foods it’s replacing in the diet.”
  • Genetic Engineering and BioTechnology News reports,
    • “Parkinson’s disease (PD) is the second-most common neurodegenerative disorder after Alzheimer’s and is caused by the degeneration of dopamine-producing neurons in the brain, leading to motor dysfunction, such as tremors and slowed movements.  
    • “Vamsi Mootha, MD, institute member at the Broad Institute, explains that a striking epidemiological association exists between heavy smoking and lowered PD risk. As smoking causes elevated carbon monoxide exposure which disrupts oxygen delivery by hemoglobin, he speculates that a low oxygen state in the brain may offer an unexpected protective mechanism against this incurable neurological disease that affects more than 10 million people worldwide. 
    • “In a new study published in Nature Neuroscience titled, “Hypoxia ameliorates neurodegeneration and movement disorder in a mouse model of Parkinson’s disease,” Mootha’s lab has now shown that low oxygen environments, similar to the thin air found at Mont Blanc, which reaches an elevation of approximately 16,000 feet, can successfully recover neuron function and alleviate motor symptoms in mice with Parkinson’s-like disease.:
    • * * * “The fact that we actually saw some reversal of neurological damage is really exciting,” said Mootha in a public release. “It tells us that there is a window during which some neurons are dysfunctional but not yet dead—and that we can restore their function if we intervene early enough.”
  • Health Day relates,
    • “Vaccination with the updated COVID-19 mRNA vaccine containing the severe acute respiratory syndrome coronavirus-2 Omicron JN.1 lineage [the fall 2024 vaccine] was not associated with an increased risk for 29 adverse events, according to a study published online July 28 in JAMA Network Open.
    • “Niklas Worm Andersson, M.D., Ph.D., from Statens Serum Institut in Copenhagen, Denmark, and colleagues examined the association between vaccination with JN.1-containing vaccines and the risk for 29 serious adverse events adapted from prioritized lists of adverse events of special interest to COVID-19 vaccines. Outcome rates during the first 28 days after JN.1-containing vaccine administration (i.e., the risk period) were compared to outcome rates during the remaining period.”
  • Per MedPage Today,
    • “Superagers — a group of adults over age 80 with the memory capacity of much younger people — maintained good brain morphology, tended to be gregarious, and appeared to be resistant to neurofibrillary degeneration and resilient to its consequences, more than two decades of research showed.
    • “In contrast to neurotypical peers who had age-related brain shrinkage, this group had a region in the cingulate gyrus that was thicker than younger adults, reported Sandra Weintraub, PhD, of Northwestern University Feinberg School of Medicine in Chicago, and colleagues.
    • “Superagers also had fewer Alzheimer’s-related brain changes, greater size of entorhinal neurons, fewer inflammatory microglia in white matter, better preserved cholinergic innervation, and a greater density of evolutionarily progressive von Economo neurons, Weintraub and colleagues wrote in a perspective piece in Alzheimer’s & Dementia.
    • “No particular lifestyle was conducive to superaging, the researchers said. Some superagers appeared to follow all conceivable recommendations for a healthy life. Others did not eat well, enjoyed smoking and drinking, shunned exercise, suffered stressful life situations, and did not sleep well.
    • “Superagers also did not seem to be medically healthier than their peers and took similar medications as they did. However, the superager group was notably sociable, relishing extracurricular activities. Compared with their cognitively average peers, they rated their relationships with others more positively. On a self-reported questionnaire of personality traits, they tended to endorse high levels of extraversion.
    • “It wasn’t the social and lifestyles aspects of superaging that surprised the researchers; it was “really what we’ve found in their brains that’s been so earth-shattering for us,” Weintraub said in a statement.”

From the healthcare artificial intelligence front,

  • Fierce Healthcare informs us,
    • “OpenAI released its most advanced reasoning model, GPT-5, which it touts as its most useful model for healthcare.
    • “The application of ChatGPT for healthcare played a leading role in the company’s Summer Update meeting on Thursday, during which it did live demos of the upgraded model. 
    • “Sam Altman, CEO of OpenAI, said health is one of the top reasons consumers use ChatGPT, saying it “empowers you to be more in control of your healthcare journey.” The company prioritized improving its healthcare features for this version of the product, Altman said. 
    • “GPT-5 will be available on the free version of the ChatGPT app, which means more consumers could start to rely on the product for assistance in making treatment decisions, understanding test results and determining what questions they should ask their doctors in the clinic.” 
  • Beckers Health IT points out,
    • “Oakland, Calif.-based Kaiser Permanente has been experimenting with AI in its patient portal, increasing patient engagement and experience in the process.
    • “The health system’s Southern California Permanente Medical Group, headquartered in Pasadena, launched the Kaiser Permanente Intelligent Navigator for its 4.9 million patients in October. The platform allows patients to chat with AI via a text box to book appointments and connect with the care they need.
    • “Care is local, but at the same time it’s virtual and it’s become a global commodity,” Khang Nguyen, MD, assistant executive medical director for care transformation at Southern California Permanente Medical Group and chief medical officer of care navigation for the Permanente Federation, told Becker’s. “So patients are really expecting artificial intelligence to support healthcare in a way that is supporting other industries, in the sense that people are able to describe what they want versus being given choices.” * * *
    • “In a study that evaluated nearly 3 million patient encounters using the AI between October and March, the tool detected urgent medical issues with 97.7% accuracy and recommended appropriate care paths with 88.9% accuracy. Patients successfully booked appointments more than half the time, compared to the industry average of 30%. The portal’s patient satisfaction scores went up by about 9%.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly shares plunged about 14% in midday trading Thursday after the company reported less-than-stellar results of a new study of an experimental anti-obesity pill that is expected to become a blockbuster.
    • “The pill helped people lose up to about 12% of their body weight after more than a year of treatment. The results could clear the way for the shot alternative to be on the market next year, but the magnitude of weight loss fell short of Wall Street expectations.
    • “The drugmaker also raised its earnings outlook for the year after revenue surged in its latest quarter on continued demand for its weight-loss and diabetes treatments.”
    • “The Lilly pill, orforglipron, is expected to become a big seller if regulators approve it for sale. Morgan Stanley analysts had said that under their bull-case scenario, the drug’s use for both obesity and diabetes could generate annual sales of up to $40 billion by 2033.
    • “Yet the latest clinical-trial results may dent some of that enthusiasm. The magnitude of weight loss fell short of what some analysts were predicting: 13% to 15% or more. 
    • “The Lilly pill is one of two that could hit the market within the next year or so, ushering in a new chapter of the weight-loss drug boom. Novo Nordisk has applied for regulatory approval of an anti-obesity pill version of its Ozempic and Wegovy, which could become available by the end of this year.”
  • Modern Healthcare relates,
    • “Aetna will end nearly 90 Medicare Advantage plans across 34 states in 2026, the company notified third-party sellers this week.
    • “The CVS Health subsidiary’s financial performance has represented a bright spot in the Medicare Advantage market compared with competitors such as UnitedHealth Group. This month, CVS Health raised its annual earnings guidance amid a $2 billion turnaround plan. The company cut the second-most plans in 2025, after Humana.
    • “The majority of the Medicare Advantage plans Aetna plans to eliminate next year are PPOs. Beginning in September, Aetna will stop paying commissions to brokers that enroll new members in these plans, according to a notice the company distributed to brokers on Monday.”
  • and
    • “UPMC and GoHealth Urgent Care have rebranded 81 urgent care centers as part of a joint venture between the two organizations. 
    • “The centers span Pennsylvania and West Virginia and offer care for non-life-threatening ailments, including flu, fever, earaches, insect bites, sprains, simple fractures and cuts requiring stitches. They will also offer virtual care options and are staffed with UPMC clinicians, according to a Thursday news release.
    • “The centers were previously owned by UPMC, including sites it acquired last month from MedExpress, another urgent care provider. Financial details of the joint venture were not disclosed.” 
  • Beckers Payer Issues adds,
    • “As major insurers pull back on their Medicare Advantage offerings, health system-owned plans told Becker’s they’re eyeing an opportunity to regain ground ahead of the annual enrollment season.” * * *
    • “I do think it’s an opportunity. Over time, the playing field is going to level somewhat, which is going to be a challenge for the nationals. For the community health plans, I think it’s going to be a benefit,” Rob Hitchcock, president and CEO of Intermountain’s Select Health, said.
    • “What you want is a healthy mix. You do want the national players to be strong, but you also want the community health plans to be strong,” he added.
  • NFP, an Aon company, discusses pharmacy deserts.
    • “A pharmacy desert is more than just a rural problem. It’s any area, urban, suburban or rural, where people lack reasonable access to a pharmacy. That usually means:
      • “More than one mile away in urban areas.
      • “Two miles in suburban areas.
      • “10 miles in rural regions.
    • “However, distance isn’t the only factor. Even if a pharmacy technically exists nearby, lack of public transportation, limited hours or closures of independent stores can make access nearly impossible, particularly for lower-income communities or those with mobility challenges.” * * *
    • “Pharmacy deserts are growing, and they have real consequences for employee health, equity and cost. While benefit consultants cannot control the closures, clients can guide their employees toward solutions that help their people stay healthy and protected, no matter where they live.”

Midweek report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
  • Fedsmith lets us know,
    • “The summer of 2025 experienced an unusually high surge in incoming retirement claims, starting in May and continuing into June. This surge can be largely attributed to the significant number of federal employees who have left federal service through various programs, including deferred resignation, Voluntary Early Retirement Authority (VERA), and others.
    • “According to OPM, approximately 154,000 federal employees have resigned under the deferred resignation program, and OPM Director Scott Kupor said recently that he anticipates the total federal workforce reduction to be at least double that number in the near future.”
  • Per an OPM press release,
    • The U.S. Office of Personnel Management (OPM) today announced that registration is now open for its innovative Executive Development Programs, designed specifically for Senior Executives Service (SES), GS-15, and GS-14 leaders.
    • These programs are closely aligned with President Trumpʼs new Executive Core Qualifications (ECQs) for senior executives, ensuring participants develop the critical competencies needed for todayʼs federal leadership roles.
    • By focusing on these updated standards, OPM is empowering leaders to deliver meaningful results and advance the mission of government agencies nationwide, drive President Trumpʼs ambitious agenda, and improve performance and accountability across the federal government. The program is highlighted by training videos from key Trump Administration leaders and distinguished career Senior Executives.
  • The American Hospital Association News tells us,
    • “A new analysis published Aug. 6 by the Peterson Center on Healthcare and KFF found that Health Insurance Marketplace insurers will propose a median premium increase of 18% for 2026. A previous analysis reported 15% based on preliminary findings. The new findings were examined from individual market filings, which provide additional details and are publicly available. The proposal more than doubles last year’s 7% median proposed increase.
    • “Insurers are citing the increase on higher prescription drug costs as well as labor costs, inflation, the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The report found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase costs of certain drugs, medical equipment and supplies. Final rates will be determined in late summer.”
  • Bricker Graydon informs us,
    • “As employers increasingly struggle with rising health plan costs, the IRS has provided some good news.  Recently, the IRS announced that the Affordable Care Act (ACA) affordability threshold will increase to 9.96% of household income for plan years starting in 2026.  This is an increase from the 9.02% that applied to 2025.  This significant increase means employers have more room to potentially increase the employee portion of premiums for 2026. 
    • “The ACA affordability percentage is used to determine if ACA employer penalties may apply to employer-provided coverage. An employer’s health coverage will be considered affordable as long as the employee’s required contribution for the lowest-cost, self-only coverage does not exceed 9.96% of their income (or an IRS-approved safe harbor equivalent, such as the W-2, rate-of-pay, or federal poverty line methods). For example, under the federal poverty line safe harbor, monthly employee contributions will need to remain below approximately $129.89 in 2026.”

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP points out,
    • “Clarametyx Biosciences said this week that its investigational antibody treatment for cystic fibrosis patients plagued by chronic bacterial lung infections will receive priority review and development incentives from the US Food and Drug Administration (FDA).
    • “The company said in a press release that the FDA had granted CMTX-101, a monoclonal antibody designed to rapidly collapse bacterial biofilms, Fast Track and Qualified Infectious Disease Product (QIDP) designations under the Gaining Antibiotic Incentives Now Act. The two designations mean Ohio-based Clarametyx will get more frequent interactions with the agency, an expedited review process and potentially accelerated approval, and an additional 5 years of market exclusivity if CMTX-101 is approved.”
  • Cardiovascular Business reports,
    • “Boston Scientific’s Watchman device is associated with a heightened risk of air embolism events if the implant procedure is performed without positive pressure-controlled ventilation, according to the U.S. Food and Drug Administration (FDA). Air embolism is a rare, but potentially fatal complication that occurs when air enters the bloodstream and creates a blockage in a patient’s blood vessel. 
    • “According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk of negative left atrium pressure and air ingress,” according to a new FDA advisory. “This risk is especially prevalent in patients with preexisting low left atrial pressure, hypovolemia and partial upper airway collapse.”
    • “The FDA emphasized that air embolism can lead to “severe outcomes, including life-threatening or fatal consequences.” 
    • “Because of this risk, which has been associated with 120 serious injuries and 17 deaths as of July 30, Boston Scientific is updating the assembly instructions of several access systems used to implant the Watchman device in patients with nonvalvular atrial fibrillation.”
  • and 
    • “The U.S. Food and Drug Administration (FDA) is sharing additional details about a safety issue with certain Boston Scientific defibrillation leads. 
    • “According to the agency, some of the company’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) have been associated with a potential risk of rising low-voltage shock impedance (LVSI). This issue, linked to calcification, may make the devices less effective as time goes on.
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” according a new FDA advisory. “As of July 24, Boston Scientific has reported 386 serious injuries and 16 patient deaths associated with this issue.”
    • “The FDA is still reviewing the situation. At this time, the agency has not determined if this is a Class I recall. The goal of this early alert is to provide details as quickly as possible.” 

From the judicial front,

  • MedTech Dive relates,
    • “The Federal Trade Commission has moved to block Edwards Lifesciences’ planned acquisition of JenaValve Technology, citing concerns that the deal threatens to reduce competition in the market for devices to treat aortic regurgitation.
    • “The agency alleged that over two days in July 2024, Edwards signed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring transcatheter aortic valve replacement devices to market to treat the potentially fatal heart condition. Edwards closed the acquisition of JC Medical in August 2024.
    • “The FTC said Edwards’ proposed $945 million acquisition of JenaValve would combine the only two companies conducting U.S. clinical trials for a TAVR aortic regurgitation, or TAVR-AR, device.
    • “The deal threatens to reduce competition in the TAVR-AR market, likely resulting in reduced innovation, diminished product quality, and potentially increased prices for consumers,” the agency stated in a federal court complaint.
    • “The commission voted 3-0 to issue an administrative complaint and seek a temporary restraining order and a preliminary injunction to halt the transaction pending an administrative proceeding. The complaint and injunction request were filed in the U.S. District Court for the District of Columbia.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP relates,
    • “In a weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 23 more measles cases, bringing the national total for the year to 1,356 cases, the most since the United States achieved measles elimination in 2000.
    • “One more state reported cases, Wisconsin, lifting the number of affected states to 41. Three more outbreaks were reported, putting the nation’s total at 32 for the year. For comparison, the country had 16 outbreaks for all of 2024. 
    • “Of confirmed illnesses this year, 87% were part of outbreaks, compared with 69% for 2024. And of infected patients, 92% were unvaccinated or had unknown vaccination status. Though about 65% of cases occurred in children, 34% were recorded in adults ages 20 years and older.”
  • NBC News reports,
    • “A second person has now died and more than 50 people have fallen ill as part of a growing Legionnaires’ cluster in Harlem, city health officials reported Monday.
    • “The disease was initially detected on July 25; since then, two people have died and 58 people have been diagnosed, the New York City Health Department revealed in its latest update.
    • “Legionnaire’s, a type of pneumonia, is caused by the bacteria Legionella, which grows in warm water. The cases from the cluster have been found in five Harlem ZIP codes: 10027, 10030, 10035, 10037 and 10039, along with the bordering communities, according to health officials.
    • “If you’re in those ZIP codes that have demonstrated exposure, then we want you to monitor your symptoms and get to a healthcare provider as soon as you can so you can get access to antibiotics, because it is treatable,” said Dr. Tony Eyssallenne, the deputy chief medical officer for the city’s Health Department.”
  • STAT News notes,
    • “Hundreds of wildfires burning across the Canadian provinces of Manitoba and Saskatchewan are pushing smoke across Canada and the American northeast. Canadian towns close to the wildfires are experiencing the worst of the smoke pollution, but even here in Boston, there was a brief ground stop at the airport Monday due to smoke and haze. 
    • “It’s getting better, but here’s a reminder: 
      • “Wildfire smoke is particularly harmful to kids’ respiratory health. One study found that a 10-unit increase of fine particulate matter from wildfire smoke was associated with a 30% spike in pediatric admissions for respiratory problems. “It’s quite a big bit of a difference,” the lead author said.
      • “Researchers have found that people who live in areas with high levels of fine particulate matter could have a greater risk of developing dementia, with a particularly strong link seen between the condition and exposure to wildfire emissions. Still, there are a lot of questions remaining about other long-term effects.
      • “In California, between 2008 and 2010, somewhere between 52,480 and 55,710 people died prematurely due to chronic exposure to wildfire smoke. The economic impact of those deaths was at least $432 billion.”
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Aug. 5 announced a new campaign educating youth ages 12-17 on substance use, mental health and how they are connected. The campaign includes facts about drugs, including prescription medications, and how they can lead to addiction and other health problems. It also includes tips and resources to help improve mental health and recognize the link between mental health and substance use.”
  • The Washington Post reports,
    • “Seven years of investigation by scientists at Harvard Medical School has revealed that the loss of the metal lithium plays a powerful role in Alzheimer’s disease, a finding that could lead to earlier detection, new treatments and a broader understanding of how the brain ages.
    • “Researchers led by Bruce A. Yankner, a professor of genetics and neurology at Harvard Medical School, reported that they were able to reverse the disease in mice and restore brain function with small amounts of the compound lithium orotate, enough to mimic the metal’s natural level in the brain. Their study appeared Wednesday in the journal Nature.
    • “The obvious impact is that because lithium orotate is dirt cheap, hopefully we will get rigorous, randomized trials testing this very, very quickly,” said Matt Kaeberlein, former director of the Healthy Aging and Longevity Research Institute at the University of Washington, who did not participate in the study. “And I would say that it will be an embarrassment to the Alzheimer’s clinical community if that doesn’t happen right away.”
    • “Yankner, who is also the co-director of the Paul F. Glenn Center for Biology of Aging Research at Harvard, said: “I do not recommend that people take lithium at this point, because it has not been validated as a treatment in humans. We always have to be cautious because things can change as you go from mice to humans.” He added that the findings still need to be validated by other labs.”
  • Per MedPage Today,
    • “Most therapies for low back pain provide only short-term relief; it’s unclear, however, whether benefits from cognitive functional therapy (CFT) may last longer.
    • “Investigators in this study performed 3-year follow-up with participants in a 6-month trial of CFT versus usual care.
    • “Compared with usual care, patients receiving CFT either with or without biofeedback for 6 months continued to show more improvement after 3 years.”
  • Per Beckers Hospital Review,
    • “Healthcare experts are calling for the end of routine use of diphenhydramine, the active ingredient in a common allergy medication, sold as Benadryl, citing safety concerns that outweigh benefits, CNN reported Aug. 1. 
    • “It’s time to move on. For every single indication that people are using diphenhydramine, there are better drugs that are more effective at treating the symptoms people are trying to treat with fewer side effects,” said Anna Wolfsen, MD, an allergist at Massachusetts General Hospital in Boston. “I’ve had patients where I worried that diphenhydramine was impairing their ability to drive or fully participate in their daily lives.”
    • “The widely used, first-generation antihistamine is commonly used to treat allergies. However, other second-generation antihistamines, including brand names such as Claritin, Zyrtec and Allegra, offer the same or better relief with fewer side effects, experts told CNN.” 

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Hinge Health beat investor expectations on revenue in the digital musculoskeletal care company’s first public earnings results.
    • “Revenue increased 55% year over year to $139.1 million in the second quarter, the firm said in earnings released Tuesday. 
    • “The digital health company reported an operational loss of $580.7 million, compared with $17.6 million last year, driven by a stock-based compensation expense largely related to Hinge’s recent IPO, a spokesperson told Healthcare Dive.”
  • STAT News tells us,
    • “Exact Sciences announced on Wednesday that it acquired the rights to a blood-based colon cancer screening test from rival firm Freenome.
    • “Exact is paying Freenome $75 million for exclusive rights in the United States to current and future versions of the Bay Area company’s test, which is currently under review by the Food and Drug Administration. Freenome is eligible for up to $700 million in additional milestone payments.
    • “The deal ratchets up Exact’s intense competition with Guardant Health, which received FDA approval last year for its own blood-based colon cancer test.
    • “Exact had been developing its own blood-based colon cancer test. Last year, the company reported promising initial results from a study of more than 3,000 samples. But on Wednesday, the company disclosed that additional testing showed that the liquid biopsy test wasn’t quite accurate enough to win Medicare reimbursement. Instead, Exact will now look to market Freenome’s test to patients, pending approval.” 
  • Per Fierce Healthcare,
    • “Days after decreasing full-year guidance by about half a billion dollars, Oscar Health missed earnings projections for the second quarter.
    • “The insurer posted a higher-than-anticipated loss per share of 89 cents, according to estimates by FactSet, reported Sherwood News.
    • “Oscar also recorded a net loss of $228 million, one quarter after having a net profit of $275 million. The insurer saw quarterly revenues hit $2.86 billion and its medical loss ratio (MLR) climb to 91.1%.
    • “The stark jump from a MLR of 79% was due to an increase in market morbidity in the Affordable Care Act exchanges, leading to a net risk adjustment transfer accrual, CEO Mark Bertolini told investors.”
  • and
    • “Blue Shield of California is teaming up with Gemini Health to roll out a new member tool that offers greater transparency at the pharmacy counter.
    • “The tool, called Price Check My Rx, will be available in the insurer’s existing member app, allowing members to see in real time the out-of-pocket price for any new or refilled prescriptions submitted by their provider and covered under their pharmacy benefits.
    • “When the prescription is submitted electronically, the platform will send the member a push notification that prompts them to look at the pricing details and explore alternatives, including low-cost options, if they prefer. Jigar Shah, chief marketing and strategy officer for Blue Shield, told Fierce Healthcare that the tool fits within the payer’s broader goal of simplifying the patient experience.”
  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy sales jumped 67% in the second quarter, despite generic competition in the U.S. market.
    • “The company reduced its full-year guidance due to the impact of copycat versions of its diabetes and obesity drugs.
    • “Outgoing CEO Lars Fruergaard Jorgensen expressed confidence in future growth under incoming CEO Maziar Mike Doustdar.”
  • BioPharma Dive adds,
    • “Scientists at Nxera Pharma have worked for the past year to develop a pipeline of wholly owned obesity drug candidates that the Tokyo and Cambridge, U.K.-based pharmaceutical company unveiled Wednesday. Chief among the seven new programs is an oral GLP-1 agonist that Nxera says is based on “differentiated chemistry” and is distinct from a compound it discovered together with Pfizer under a research alliance. Coincidentally, Pfizer disclosed Tuesday it discontinued development of that compound, a decision Nxera said was made “due to a portfolio decision.” 
  • Per MedTech Dive,
    • “BD is investing more than $35 million to expand production of prefilled flush syringes at a facility in Columbus, Nebraska, the company said Monday.
    • “The investment will add around 50 jobs at the site and equip BD to make hundreds of millions of additional units a year to meet growing demand from U.S. hospitals and health systems.
    • “BD framed the spending as part of an ongoing commitment to its Posiflush line, which has seen it invest more than $80 million to expand production of the syringes over the past three years.”

Tuesday report

David Ermer–AHRQ, CMS, Generative AI, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SDOH, Telehealth, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Many seniors enjoy the perks that come with Medicare Advantage. But those extras—like dental coverage and free gym memberships—are being scaled back.
    • “Insurers are cutting benefits and exiting from unprofitable markets, and Wall Street is cheering them on. Once rewarded by investors for rapid expansion in the lucrative privatized Medicare program, companies are now being applauded for showing restraint amid rising medical costs and lower government payments.” * * *
    • “To be clear, major insurers aren’t exiting Medicare Advantage. Apart from Cigna, which sold its Medicare business last year, the big players are still betting on the program—some are likely to take advantage of the turmoil to increase their market share. And the market is arguably still well served and competitive, especially in densely populated areas. Even after some moderation last year, the average beneficiary this year had 42 plan options from which to choose, according to health-research nonprofit KFF. 
    • “As the industry pivots to leaner operations, Wall Street may regain confidence. But the era of red-hot Medicare Advantage growth is over, at least for now. While Democrats have led efforts to cut overpayments, Republicans also face mounting pressure to curb spending—especially after recent tax cuts, notes Deutsche’s [George] Hill. He warns that more regulatory shifts may be coming, including a potential overhaul of the star ratings system, which governs billions in bonus payments tied to plan quality and patient satisfaction.
    • “Until that picture clears, investors will continue to reward restraint and tightly managed risk. In today’s Medicare Advantage market, and across government insurance programs, growth is taking a back seat to profitability.
  • BiioPharma Dive tells us,
    • “The U.S. plans to put tariffs of up to 250% on pharmaceutical imports over the next year and a half, President Donald Trump said in a Tuesday interview with CNBC.
    • “Trump said he would put a “small tariff” on such imports initially but added that he would raise the duties to 150% and then 250% in “one and a half years maximum.” The president indicated that announcements of pharmaceutical tariffs, as well as duties on semiconductors, would be announced “within the next week or so.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the beginning of a coordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA), including the cancellation and de-scoping of various contracts and solicitations. The decision follows a comprehensive review of mRNA-related investments initiated during the COVID-19 public health emergency.
    • “We reviewed the science, listened to the experts, and acted,” said HHS Secretary Robert F. Kennedy, Jr. “BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.” * * *
    • “While some final-stage contracts (e.g., Arcturus and Amplitude) will be allowed to run their course to preserve prior taxpayer investment, no new mRNA-based projects will be initiated. HHS has also instructed its partner, Global Health Investment Corporation (GHIC), which manages BARDA Ventures, to cease all mRNA-based equity investments. In total, this affects 22 projects worth nearly $500 million. Other uses of mRNA technology within the department are not impacted by this announcement.” * * *
    • “The move signals a broader shift in federal vaccine development priorities. Going forward, BARDA will focus on platforms with stronger safety records and transparent clinical and manufacturing data practices. Technologies that were funded during the emergency phase but failed to meet current scientific standards will be phased out in favor of evidence-based, ethically grounded solutions – like whole-virus vaccines and novel platforms.”
  • Roll Call lets us know,
    • “The Trump administration is escalating its push against what has become a key part of the way states, localities and communities respond to the overdose epidemic: harm reduction. 
    • “A public health approach aimed at mitigating the negative health effects associated with drug use, harm reduction aims to prevent overdoses and infectious disease transmission.
    • “Methods can involve the use of opioid overdose reversal medications such as naloxone, providing sterile needles to limit the transmission of infectious diseases, test strips that detect fentanyl in drugs, and “safe consumption sites,” where people can use drugs under supervision in case they need intervention.” * * *
    • “In a “Dear Colleague” letter sent to states last week, Art Kleinschmidt, principal deputy assistant secretary at SAMHSA, said he doesn’t consider naloxone a harm reduction method and as such it would continue to be funded by the government. Kleinschmidt said test kits and other services can also be funded through grants.
    • “But the letter stated that federal funding can’t be used to “purchase pipes or other supplies for safer smoking kits nor syringes or needles used to inject illicit drugs” or “any other supplies to promote or facilitate drug use.” 
    • “Moving forward, SAMHSA funds will no longer be used to support poorly defined so-called “harm reduction” activities; rather, SAMHSA is providing guidance to state agency leadership and to grantees through new award terms and conditions that provide clarity on what supplies and services previously defined under the umbrella of harm reduction can be supported with SAMHSA funding,” Kleinschmidt wrote.” 

From the public health and medical research front,

  • The American Hospital Association News informs us,
    • “Patients in the hospital for surgeries had better outcomes in 2024 than they did in 2019, according to a new report released today by the AHA and Vizient. 
    • “The significant improvement aligned not only with better performance on patient safety metrics — such as reductions in infections and falls — but also with marked declines in three major surgical patient safety indicators: severe bleeding, sepsis and respiratory failure. * * *
    • “The new findings build on a report AHA released in collaboration with Vizient last year showing that hospitals and health systems performed better on key patient safety and quality measures in the first quarter of 2024 than they did before the COVID-19 pandemic. In fact, hospitals’ efforts to improve safety led to 200,000 Americans hospitalized between April 2023 and March 2024 surviving episodes of care they wouldn’t have in 2019.” 
  • MedPage Today reports,
    • “Unhealthy alcohol use is a leading cause of death and serious illness among U.S. adults.
    • “In new draft guidance, the USPSTF reaffirmed that all adults should be screened for unhealthy alcohol use and [newly] recommended brief behavioral counseling interventions when appropriate.
    • “The task force found insufficient evidence to make the same recommendation in adolescents.”
    • The public comment period ends on September 2, 2025.
  • Healio adds,
    • “Testing for hepatitis C virus infection every 6 to 12 months — or even more frequently — among people who inject drugs could be a beneficial, cost-effective strategy, according to a study published in JAMA Health Forum.“
    • USPSTF recommends hepatitis c screening for adults aged 18 to 79 without known liver disease.
      • “Most adults need to be screened only once. Persons with continued risk for HCV infection (e.g., PWID) should be screened periodically. There is limited information about the specific screening interval that should occur in persons who continue to be at risk for new HCV infection or how pregnancy changes the need for additional screening.”
        • The JAMA Health Forum study fills in the screening interval information gap.
  • Per STAT News,
    • “Nathan Young, a community neurologist at the Mayo Clinic, recently saw a patient whose diagnosis he couldn’t quite nail down. Parkinson’s seemed a likely possibility, but Young was concerned she might instead have a rare neurological disorder called progressive supranuclear palsy, or PSP, which can progress much more rapidly. 
    • “I opened a can of worms,” said Young: He ordered a PET scan of the patient’s brain, but the radiology report only confused matters. Instead of ruling out PSP, it suggested yet a third diagnosis: Alzheimer’s. 
    • “Normally at this point, Young would call in other specialists as reinforcements, including Mayo’s renowned experts. But this time he had something different to help: a new AI tool called StateViewer.”
    • “Developed by Mayo’s Neurology AI program, StateViewer takes scans like the one Young ordered — they’re called FDG-PET scans, named for the radioactive tracer they use — and spits out a report of similar brains that have been scanned in Mayo’s clinical and research networks. The output: a differential diagnosis of nine potential types of dementia. In development over the last several years, StateViewer hit the rails at all three Mayo campuses four months ago, and it’s been run thousands of times on patients’ brain scans.”
  • and
    • “Vertex Pharmaceuticals said Monday afternoon that its next-generation non-opioid pain reliever failed to significantly outperform placebo in a Phase 2 trial.
    • “The experimental drug, codenamed VX-993, is similar to the company’s recently approved pill Journavx but could potentially be given at higher doses and formulated as an IV infusion. The hope is that it could thus provide superior relief or offer an alternative to IV opioids. But after Monday’s results, the company said it would discontinue efforts to develop the drug as a single-agent medicine for acute pain.”
    • “We do not plan to advance VX-993 as monotherapy in acute pain, because we do not expect that it will be superior to our [existing] NaV1.8 inhibitors,” said CEO Reshma Kewalramani during a Monday afternoon earnings call with investors, using a scientific shorthand for the class of drugs. She noted that the company will continue a trial testing the drug in patients with diabetes who have chronic nerve pain.”
  • Cardiovascular Business points out,
    • “A surgeon at Cleveland Clinic has performed the world’s first robotic-assisted heart surgery of its kind, using CardioPrecision’s CoreVista Robot Enabling Platform to implant Corcym’s Perceval Plus aortic heart valve through a small incision in the patient’s neck.
    • “The successful operation, known as AVATAR (Advanced Videoscopic Aortic valve surgery by Transcervical Approach using Robot assistance), was performed by Marijan Koprivanac, MD, a cardiovascular surgeon with Cleveland Clinic’s Heart, Vascular and Thoracic Institute. Other robotic techniques for aortic valve replacement have already been in use, including the robotic aortic valve replacement procedures developed at the WVU Heart and Vascular Institute, what sets this approach apart is the fact that everything is done through that small incision in the neck. 
    • “Combining the artificial heart valve with this new surgical technology means patients should experience less pain and time in the hospital following heart surgery,” Koprivanac said in a statement. “In fact, we believe that this may be one of the least invasive surgical heart valve replacement options now available.”
  • Per Genetic Engineering and Biotechnology News,
    • “Amyotrophic lateral sclerosis (ALS) is an incurable neurological disorder affecting motor neurons (MNs), which are nerve cells in the brain and spinal cord that control voluntary muscle movement and breathing. Many ALS clinical trials, including those testing promising drugs, have fallen short of expectations, commonly because the extent of the disease can vary, and not all patients respond the same way to medications.
    • “Scientists at Case Western Reserve University now report new insights into one type of ALS, that may point towards a therapeutic approach for different types of the disorder. The team studied inducible pluripotent stem cell (iPSC)-motor neurons (MNs) carrying the P56S mutation in a protein called vesicle-associated membrane protein-associated protein-B (VAPB), which is responsible for a familial form of ALS. Their findings provided evidence that the mutation activates integrated stress response (ISR) via mitochondrial dysfunction in motor neurons and also indicated that pharmacological inhibition of ISR using ISRIB helped to rescue ALS-associated phenotypes in both VAPB P56S and patient-derived IPSC-MNs.
    • “Although the research centered on this rare form type of ALS, the investigators are optimistic the positive results could provide clues for potentially treating the devastating disorder more broadly. Study lead Helen Cristina Miranda, PhD, an associate professor of genetics and genome sciences at Case Western Reserve’s School of Medicine, suggested, “This work could help lay the foundation for genetically informed clinical trials.”
    • “Miranda and colleagues reported on their study in EMBO Molecular Medicine, in a paper titled “Convergent activation of the integrated stress response and ER–mitochondria uncoupling in VAPB-associated ALS,” concluding, “This is the first study to mechanistically connect a known ALS mutation with ISR activation, highlighting the potential for mutation-specific therapeutic targeting and patient stratification in ISR-modulating clinical trials.”
  • The National Institutes of Health announced a “new study to test if mothers’ diet prevents early sign of food allergy in babies. NIH trial to assess if eating peanuts, eggs during pregnancy, breastfeeding protects infants.”
    • “The study, called Expecting Mother’s Study of Consumption or Avoidance of Peanut and Egg (ESCAPE), will be led by Kirsi Järvinen-Seppo, M.D., Ph.D., chief of Pediatric Allergy and Immunology and Founders’ Distinguished Professor in Pediatric Allergy at University of Rochester Medicine. Results are expected in 2029. 
    • “More information about the trial, including contacts for people who are interested in participating, is available at ClinicalTrials.gov under study identifier NCT06260956.”
  • NIH Research Matters covers the following topics this week: “Treating CoQ10 deficiency | Specialized blood vessels in organoids | Fat-fueled neurons.”
  • Beckers Hospital Review identifies “seven new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • CIGNA, writing in LinkedIn, discusses the importance of access to mental health services.
    • “Virtual care appointments have emerged as a valuable tool in providing mental health services, particularly in remote or underserved areas. Connecting with mental health professionals via telephone, video calls, and even smart phone apps, make it easier to access care without the need for travel. Additionally, virtual care often reduces wait times, providing quicker access to necessary care.
    • “Community-based mental health programs are another effective approach. These programs use the strengths and resources of local communities to provide support and care. Community health workers, peer support groups, and local organizations can play a vital role in delivering mental health services and promoting mental well-being.
    • “Integrating mental health services into primary care is also promising. By training primary care providers to recognize and address mental health issues, individuals can receive holistic care that addresses both their physical and mental health needs. This integration can help improve overall health outcomes.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Pfizer and other large pharmaceutical companies are taking seriously President Donald Trump’s demand that drugmakers make more of their medicines available direct to consumers in the U.S. at lower cost, Pfizer CEO Albert Bourla said Tuesday.
    • “We have serious discussions in the industry,” Bourla told investors on a conference call Pfizer held to discuss its earnings for the second quarter. “I’m connected very often individually with all the major companies, and they are all ready to roll up their sleeves and execute something like that.”
  • MedTech Dive relates,
    • “Alcon has agreed to buy implantable lens maker STAAR Surgical for about $1.5 billion in total equity value, the companies said Tuesday.
    • “Alcon, which will purchase all outstanding shares of STAAR for $28 per share in cash, expects STAAR’s refractive surgery offerings to complement Alcon’s laser vision correction business.
    • “BTIG analyst Ryan Zimmerman said Alcon is getting “a solid deal” given STAAR’s setbacks in the China market. The company is betting on a recovery in China and the longer-term health of lens-based refractive surgery, said the analyst.”
  • Per Fierce Healthcare,
    • “Shares of Hims & Hers tumbled 12% in after-hours trading Monday after the company’s second-quarter revenue missed Wall Street analysts’ expectations.
    • “The company faces headwinds in its compounded GLP-1 drug business after pharma giant Novo Nordisk pulled the plug on a monthlong collaboration to make its weight loss drug Wegovy available on the telehealth company’s platform. The company had to off-board GLP-1 subscribers from the branded version of the drug, executives said.
    • “Hims & Hers continues to sell compounded semaglutide, the active ingredient in Novo’s Wegovy and Ozempic drugs, and these generic versions are more affordable than the branded drugs.
    • “Analysts, however, seem pleased by what they see as strong results and the online health and wellness company’s growth plans, including international expansion, new hormone health offerings and building out standalone lab testing.”
  • and
    • “Online therapy provider Talkspace continues to make big investments in artificial intelligence, seeing opportunities to improve the experience for patients and cut down on paperwork for providers.
    • “Talkspace connects people via an app with therapists who provide counseling remotely, either over the phone, by video chat or by text.
    • “The company is building out foundational large language models specifically for behavioral health using its internal, de-identified clinical data sets, as it claims to have the “largest behavioral health datasets in the industry,” consisting of millions of therapeutic interactions on the Talkspace platform over the past 12 years.
    • “Unlike existing, horizontal, general-purpose LLMs, we are working closely with mental health clinicians experienced with evidence-based therapeutic frameworks,” CEO Jon Cohen, M.D., told investors during the company’s second-quarter earnings call Tuesday. “Talkspace behavioral health LLMs are being developed specifically to understand the language complexity and workflows of mental health delivery. Once up and running, these behavioral health LLMs will be an integral part of how we provide higher-quality care to our Talkspace members.”
  • Modern Healthcare reports,
    • “Virtual behavioral health provider Cerebral announced Tuesday it had acquired Resilience Lab, which offers therapy and medication management through its online platform. The deal, which closed last week, includes Resilience’s clinician development program aimed at training and supporting early-career therapists. 
    • “The combined organization will be led by Cerebral CEO Brian Reinken under the Cerebral brand, with Resilence Lab Co-founder Marc Goldberg holding the president role, according to a spokesperson. Dr. Carl Marci will join the company as chief medical officer, and Resilience Lab Co-founder Christine Carville will serve as chief clinical officer. Cerebral representatives declined to disclose financial details of the deal.”
  • and
    • “Quest Diagnostics has completed its acquisition of some clinical testing assets from Spectra Laboratories, a subsidiary of dialysis company Fresenius Medical Care.
    • “Under the agreement, Quest will provide dialysis-related clinical testing to independent clinics formerly served by Spectra Laboratories.
    • “As part of a separate deal with Fresenius, Quest said in a Tuesday news release it expects to complete the acquisition of select dialysis-related water testing assets by the end of the year. It also said it plans to start providing comprehensive dialysis-related laboratory services for centers operated by Fresenius in the U.S. The transition of services is slated to be completed by early next year.”

Monday Report

David Ermer–FDA, Federal employment benefits, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • PhRMA points out “August is National Immunization Awareness Month (NIAM)—a timely reminder of vaccines’ vital role in protecting our health, especially as preventable disease outbreaks rise and kids head back to school.”
  • Per an HHS news release,
    • “Health and Human Services Secretary Robert F. Kennedy, Jr. and U.S. Food and Drug Administration Commissioner Dr. Marty Makary today joined Secretary of Agriculture Brooke L. Rollins to celebrate her signing of six new Supplemental Nutrition Assistance Program (SNAP) state waivers to advance the Trump Administration’s priority to Make America Healthy Again. Iowa Governor Kim Reynolds and West Virginia Governor Patrick Morrisey joined them on the MAHA Monday event on the National Mall.
    • “MAHA Monday marks the second day of the U.S. Department of Agriculture’s (USDA) Great American Farmers Market 2025, a weeklong celebration of food, family, and farming to showcase American agriculture as part of the Trump Administration’s events leading up to the 250th anniversary of America’s founding next year.
    • “The SNAP waivers for West Virginia, Florida, Colorado, Louisiana, Oklahoma, and Texas amend the statutory definition of food for purchase and end the subsidization of popular types of junk food beginning in 2026.”
  • The New York Times adds
    • “New research suggests that people can lose more weight by avoiding ultra processed foods, even those that are typically considered healthy.
    • “The study, published today in the journal Nature Medicine, is the largest and longest clinical trial yet to examine the effects of ultra processed foods on weight. Participants lost twice as much weight when they followed diets made up of minimally processed foods, like pasta, chicken, fruits and vegetables, as they did when they followed diets with ultra processed foods that met nutrition standards, such as ready-to-heat frozen meals, breakfast cereals, protein bars and shakes.”
  • The Washington Post reports,
    • “The White House does not plan to require health insurers to provide coverage for in vitro fertilization services, two people with knowledge of internal discussions said, even though the idea was one of President Donald Trump’s key campaign pledges.” * * *
    • “A senior administration official, who also spoke on the condition of anonymity to discuss internal talks, said that while expanding IVF access remains a “huge priority” for Trump, the president can’t legally make IVF an essential health benefit without Congress first approving legislation to do so. It is unclear whether the administration plans to ask lawmakers to take up a bill, but the two people said that forcing insurance companies to cover IVF is not currently on the table.”
  • Tammy Flanagan, writing in Govexec, explains “How federal employees can check if their retirement estimate is accurate. Estimating your post-retirement income isn’t just math, it’s about getting the right data, understanding your service credit and avoiding costly missteps.”

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • “The FDA approved aceclidine 1.44% ophthalmic solution (Vizz) for adults with presbyopia, or age-related blurred near vision, maker Lenz Therapeutics announced on Thursday [July 31].
    • It marks the first aceclidine-based solution to be approved for the condition, which affects an estimated 128 million Americans — almost half the adult population.
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of Philips Respironics V30, A30 and A40 ventilators due to the potential for serious injury or death. The company is updating use instructions due to the risk of failure in the ventilator inoperative alarm, which can cause therapy interruption or loss. The recall involves correcting the devices and does not call for removing them from where they are used or sold.” 
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA. Keveney most recently served as Acting General Counsel of HHS, where he led the Department’s legal team in advancing key administration priorities and ensuring rigorous legal standards across public health programs.” * * *
    • “Robert Foster, the Department’s Principal Deputy General Counsel, will assume the role of Acting General Counsel of HHS. He will remain FDA Chief Counsel for Food, Research, and Drugs. Foster has deep experience in administrative law and public health litigation and has been a trusted advisor to Secretary Robert F. Kennedy, Jr. on matters ranging from vaccine regulation to bioethics.
    • “President Trump earlier this year nominated Michael Stuart, a member of the West Virginia Senate and former United States Attorney for the Southern District of West Virginia, as General Counsel of HHS. The U.S. Senate Committee on Finance held his nomination hearing on July 31, 2025.”

From the public health and medical research front,

  • STAT News relates,
    • “The Gates Foundation said Monday that it would commit $2.5 billion through 2030 to support dozens of different approaches for improving women’s health, from new medicines to prevent maternal mortality to vaccines to curb infections that disproportionately affect women.
    • “The figure represents an increase of about a third in the foundation’s funding for women’s health and maternal health compared to the previous five years, and is a small illustration of the kinds of commitments that Bill Gates, the foundation’s chairman and founder, is making as he seeks to donate the vast majority of his $114 billion fortune before winding down the foundation over the next 20 years. It is the largest funding commitment the Gates Foundation has made in women’s health.”
  • The Wall Street Journal reports,
    • “People under age 50 have been appearing increasingly at doctors’ offices in the past few decades, complaining of blood in their stool, abdominal trouble or unexplained weight loss. The diagnosis: colorectal cancer. And by that time, it was often too late.
    • “But that paradigm is finally starting to shift, at least for patients in their 40s. 
    • “There has been a jump in people aged 45 to 49 getting screened for colorectal cancer, after recent medical guidelines lowered the screening age for those at average risk. As a result, the disease is being caught sooner, when it is more curable and the treatment is less grueling, according to new research from the American Cancer Society. 
    • “The recent screening recommendations designed to catch cases sooner appear to be working. 
    • “It’s thrilling to see this,” said Rebecca Siegel, an epidemiologist at the ACS and an author of the new research. “It means fewer deaths and higher quality of life for people who are diagnosed.” 
  • Per MedPage Today,
    • “Compared with untreated flu, oseltamivir [Tamiflu] treatment reduced the risk of serious neuropsychiatric events in children.
    • “Prescribing information for oseltamivir carries warnings about abnormal behavior in kids with flu based on case reports.
    • “Concerns about possible side effects may contribute to oseltamivir being underused in kids at high risk for flu complications.”
  • Diagnostic Imaging notes,
    • “Emerging research suggests that mammography may play a viable role in detecting pregnancy-related breast cancer (PABC), even among women with extremely dense breasts.
    • “For a retrospective study, recently published in Clinical Imaging, researchers reviewed mediolateral oblique and craniocaudal mammogram views for 167 women (mean age of 37) with newly diagnosed PABC as well as ultrasound imaging for 146 women in the cohort. The study authors noted use of different mammography techniques, including full-field digital mammography (78 patients) and digital breast tomosynthesis (DBT) (89 patients).
    • “The researchers also pointed out that 97.6 percent of the cohort had dense breasts with 77 percent having extremely dense breasts. Eighty-two percent of the women were lactating, and 18 percent of the cohort were pregnant.”
  • Per the AHA News,
    • “Nearly 57% of mothers did not attend a postpartum follow-up visit three to eight weeks after giving birth, according to a report published July 29 by Cedar Gate Technologies. The rate was higher for younger mothers, as nearly 61% of those aged 20-24 did not attend follow-up appointments. Cedar Gate analyzed a national database of millions of commercially insured patients from July 2022 to June 2023. Previous estimates from the American College of Obstetrics and Gynecology suggested nearly 40% of women did not attend postpartum visits.” 
  • The American Medical Association lets us know what doctors wish their patients knew about Huntington’s Disease.
  • Per Fierce Pharma,
    • “While the JAK inhibitor market for alopecia areata (AA) has grown increasingly crowded in recent years, Rinvoq’s clinical performance in the hair follicle-attacking autoimmune disease could earn AbbVie a prominent seat at the table.
    • “After 24 weeks of treatment, Rinvoq (upadacitinib) at two doses—15 mg and 30 mg—helped 44.6% and 54.3% of adult alopecia patients achieve 80% or more scalp hair coverage, respectively, in a phase 3 trial. That compared to just 3.4% of patients on placebo who achieved the same level of hair growth.
    • “Patients enrolled in the study entered at a baseline of roughly 16% scalp hair coverage, as determined by the severity of alopecia tool (SALT), AbbVie said in a July 30 press release.”
  • Radiology Business informs us,
    • “Medical imaging accounts for 4 of the 5 most prevalent low-value healthcare services among Medicare beneficiaries, according to new research published Friday. 
    • “Imaging for plantar fasciitis” was the most frequently delivered unnecessary exam, occurring nearly 84 times per 100 Medicare beneficiaries, experts write in JAMA Health Forum. Low-value imaging for headache (76/100), syncope (72/100) and lower back pain (39/100) also made the top five, with vertebroplasty and kyphoplasty at No. 4. 
    • “The findings are based on a review representing claims from over 3.7 million Medicare beneficiaries treated between 2018 and 2020. Altogether, the payment program spent approximately $484 million on 15 different low-value imaging services, a figure that balloons to nearly $584 million when factoring in beneficiaries’ out-of-pocket costs.  
    • “Findings of this cross-sectional study highlight that reforms aimed at reducing spending for low-value services are feasible to achieve billions in savings without compromising patient health,” David D. Kim, PhD, and A. Mark Fendrick, MD, with the universities of Chicago and Michigan, respectively, wrote Aug. 1.”

From the U.S. healthcare business front,

  • Beckers Payer Issues identifies seventeen underrated skills that payer leaders need and further reports,
    • “Bloomington, Minn.-based HealthPartners is launching Simplica NextGen Copay, a health plan with no deductible or coinsurance for in-network care.
    • “With the plan, beneficiaries will also see what they’ll pay upfront before scheduling, according to an Aug. 4 HealthPartners news release. Copay amounts for specific services at each hospital or clinic vary based on the quality and affordability of the care delivered.
    • “The plan is launching on Jan. 1, 2026, and will initially be available to large-group, self-insured employers in the Twin Cities metro and surrounding counties, according to the release.
    • “We developed Simplica in response to the growing demand for more predictable benefits,” HealthPartners president and CEO Andrea Walsh said in the release. “This plan gives members the cost clarity and ease they expect from their health plan and guides them in making informed decisions about where to get the care they need.”
  • Modern Healthcare reports,
    • “Brian Pieninck has been tapped as the next president and CEO of GuideWell and its insurer subsidiary Florida Blue, effective Oct. 1.
    • “Pieninck currently serves as president and CEO of CareFirst BlueCross BlueShield and is chair of the Blue Cross Blue Shield Association’s board of directors. He will succeed Pat Geraghty, who in March announced his plans to retire Dec. 31, after 14 years with the organization. 
    • “Pieninck joined nonprofit CareFirst, an independent licensee of the Blue Cross Blue Shield Association, in 2015 as executive vice president of the large group strategic business unit before becoming chief operating officer in 2017. In 2018, he was named president and CEO of the company. 
    • “Prior to CareFirst, he held multiple leadership roles during 19 years at Aetna.”
  • and
    • “Kelly Munson has been named the next president and CEO of Independence Health Group, effective Oct. 1.
    • “Munson, who currently serves as president and CEO of Independence Health subsidiary AmeriHealth Caritas, will succeed Gregory Deavens, who earlier this year announced his plans to retire. Deavens will remain at the company through December to support the leadership transition, according to a Monday news release. 
    • “In addition to her role at Independence Health Group, Munson will shift into an oversight position at AmeriHealth Caritas.” 
  • Beckers Hospital Review calls attention to six planned hospital reopenings and adds that
    • “St. Luke’s Des Peres Hospital in St. Louis officially closed Aug. 1, a spokesperson for the Chesterfield, Mo.-based health system told Becker’s.
    • “The decision follows years of declining patient volumes and mounting financial challenges that made continued operation of the 143-bed hospital as an acute care facility unsustainable.” 

Weekend update

David Ermer–Congress, Medical / Rx research, U.S. Healthcare, Uncategorized–
  • Roll Call adds,
    • “President Donald Trump gave Senate Republicans permission to begin their August recess Saturday night [August 2, 2025], shortly before Democratic and Republican leaders agreed to quickly vote on seven final civilian nominees but none of the more than 100 still pending on the calendar.
    • “The agreement allowed for votes to begin on cloture and confirmation of the nominees without debate. Among those confirmed under the deal was Jeanine Pirro, who was nominated by Trump to be U.S. attorney for the District of Columbia.
    • “The directive from Trump took pressure off of Senate Majority Leader John Thune, R-S.D., to clear the executive calendar and confirm all of Trump’s pending nominees before the recess.” 
  • The Wall Street Journal reports,
    • “The Senate late Friday [August 1, 2025,] passed more than $180 billion in funding for veterans programs, new military facilities, the Agriculture Department and the Food and Drug Administration, as lawmakers moved to reassert their control over federal spending amid challenges from the Trump administration.
    • “The Senate approved the bulk of the spending in a 87-9 vote. It separately cleared a measure funding Congress’s own operations as well as related entities that audit federal spending and evaluate the budgetary implications of federal laws. The legislation must go back to the House, which is on recess and will return for legislative business in September.
    • “We are on the verge of an accomplishment that we have not done since 2018, and that is, pass appropriations bills across the Senate floor prior to the August recess,” Senate Appropriations Committee Chair Susan Collins (R., Maine) said shortly before the measures passed. “That is exercising our constitutional responsibility for the power of the purse.”
    • “Sen. Patty Murray (D., Wash.), the top Democrat on the panel, said, “I believe Congress should decide how to spend taxpayer dollars. This is how we do it.”

From the public health and medical research front,

  • The Wall Street Journal points out,
    • “Falls are the leading cause of injury for people 65 and older, but the factors that lead to falls can start much earlier.
    • “The risk of falling in a given year doubles with every additional related issue—including reduced muscle strength, balance problems, medication side effects and even forgetting to take that medicine—according to a recent research paper.
    • “That’s why medical experts say that, beginning at age 65, everyone should have an initial screening to determine their personal risk level.
    • “Many people think only frail older people in nursing homes fall. But even the youngerold—those who are healthy and active—can fall,” says Emily Nabors, associate director of innovation at the National Council on Aging.
    • “The nonprofit offers a short online questionnaire that provides a fall-risk score, but Nabors suggests people also get a more comprehensive assessment from a doctor or physical therapist.
    • “Even if you’re at low risk now, there are things you can do to stay that way. And they go beyond removing trip hazards in your home.”
  • The Washington Post lets us know,
    • “Shortly after finishing breakfast six years ago, Brian Farrington felt some discomfort and thought it was heartburn. He popped a few Tums but hours later began perspiring profusely and experiencing chest pain.
    • “The next morning, Farrington, who was 53 and seemingly healthy, headed to the hospital and was shocked to learn he had suffered a heart attack. He had several blockages in his right artery. Previously, Farrington had been told his cholesterol was “borderline high” but did not require medication.
    • “As the resident of Columbus, Ohio, recovered, he considered a nagging question: Why was there so much premature heart disease in his family? His grandfather and three great-uncles had died of heart disease in their 40s, and his father had gotten a stent in his 60s. He decided to dig deeper.
    • “Farrington eventually discovered he had a heart threat that he — and many other people — had never even heard of: High levels of a fatty particle called Lipoprotein(a). The molecule is similar to LDL, the “bad” cholesterol that circulates in the blood and can promote coronary plaque, increasing the risk of heart attacks.
    • “But Lp(a) carries an extra protein that makes it an even bigger cardiac risk factor than LDL, studies have shown. Higher-than-normal levels encourage the development of blood clots as well as plaque, sharply raising the risk of stroke, heart attack and other severe problems — even among younger people with normal levels of LDL, doctors say.“
  • and
    • “In March 2024, radiation oncologist Sanjay Mehta had been dealing with painful Achilles tendinitis on his left ankle for over a year. He’d tried steroid injections and PRP (platelet-rich plasma) injections, which Mehta said eventually did the trick.
    • “But when his right Achilles started hurting three months later, he opted for a different approach. He had recently started offering low-dose radiation therapy to treat some patients suffering from inflammatory conditions and thought: Why not try it himself? After six self-administered low-dose X-rays, covered by insurance, he found he was pain-free — and he began offering the therapy to more patients with similar noncancerous conditions.
    • “The main surprise was … why didn’t I think of this earlier?” he said.
    • “Mehta is part of a growing trend among U.S. radiation specialists, who have begun offering low-dose X-ray therapy for benign conditions such as arthritis, plantar fasciitis, Peyronie’s disease and thick raised scars, or keloids.
    • “After the American Society for Radiation Oncology discussed the use of low-dose radiation therapy for nonmalignant conditions in its spring 2024 quarterly newsletter, its use began to pick up steam, Mehta said. Unlike radiation therapy for cancer, LDRT, as its name suggests, uses low doses to suppress inflammatory cells. Mehta said six LDRT treatments expose the patient to about the same amount of radiation as in one cancer treatment or what someone might get from “a few” CT scans.”
  • The New York Times tells us that “‘Japanese Walking’ Is a fitness trend worth trying. The workout is simple, and its health benefits are backed by nearly 20 years of research. Check it out.
  • Per MedPage Today,
    • “An investigational subcutaneous autoinjector showed comparable efficacy and safety to the IV formulation of lecanemab (Leqembi) for maintenance treatment in early Alzheimer’s disease, researchers said here.
    • “Continued lecanemab treatment with 360 mg subcutaneous dosing resulted in a similar additional reduction of amyloid PET over 4 years of treatment as continuing biweekly IV lecanemab, reported Larisa Reyderman, PhD, of drugmaker Eisai, at the Alzheimer’s Association International Conference (AAIC).

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, NCQA, OPM, U.S. Healthcare–
  • OPM Director Scott Kupor explains “What They Got Wrong About the Deferred Resignation Program.”
    • “We designed the DRP as a practical, humane, and voluntary option to accelerate workforce transitions in a system that desperately needed movement. Employees were given the option to retire early and receive eight months of paid leave; in return, the government will save $20+ billion in costs, annually.
    • “By the way, the DRP isn’t unusual. It mirrors what employers in the private sector across the country do every day, offer certainty and clarity to employees while restructuring in a responsible, mission-first way. What’s “unusual” is pretending government is exempt from the same pressures every other organization faces in a rapidly changing world and not understanding the simple difference between one-time severance costs and ongoing annual cost savings.”
  • The Plan Sponsor Council of America lets us know,
    • “The Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing on Thursday to discuss lowering health care prices. The hearing was entitled “Making Healthcare Affordable: Solutions to Lower Costs and Empower Patients.”
    • “Testifying witnesses and Senators agreed universally that price transparency is an important area of reform. “We all agree that price transparency is important,” noted Sen. Bill Cassidy (R-La.) the Chair of the Committee.
    • “[Sen.] Cassidy highlighted one proposed bill, the Patients Deserve Price Tags Act.”
  • Healthcare Dive informs us,
    • Regulators finalized an interoperability and technology rule on Thursday that aims to lessen administrative burden on providers, including through updates to prior authorization processes.
    • The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology’s HTI-4 rule lays out new and updated health IT certification criteria for electronic prior authorization, electronic prescribing and real-time prescription benefit checks. 
    • The regulation should help clinicians spend less time on paperwork, the ASTP said. “We believe that this work will help patients and providers determine patient benefits at the point of care,” Dr. Thomas Keane, assistant secretary for technology policy and national coordinator for health IT, said during a press briefing Friday.
  • Beckers Health IT tells us,
    • “Several health systems are voicing support for a new federal initiative to improve data exchange and expand access to digital health tools, following a July 30 White House summit that formalized a public-private partnership aimed at building a more connected health ecosystem.
    • “The Centers for Medicare & Medicaid Services, alongside the Department of Health and Human Services, convened more than 60 organizations — including EHR vendors, technology firms and provider networks — to sign onto the CMS Interoperability Framework. Eleven health systems, including Cincinnati-based Bon Secours Mercy Health, Renton, Wash.-based Providence, Cleveland Clinic, Salt Lake City-based Intermountain Health, Sioux Falls, S.D.-based Sanford Health and Atlantic City, N.J.-based AtlantiCare, committed to promoting adoption of digital tools among their patients.” * * *
    • “CMS said it plans to roll out the first phase of its interoperability framework — allowing patients to access claims data from participating provider networks — in early 2026. Future components include AI-powered care navigation tools, upgrades to Medicare Plan Finder and a digital health app library.”
  • The American Hospital News reports,
    • “The Trump administration July 31 announced modified reciprocal tariffs for several nations that would begin Aug. 7, updating those previously announced in April. Countries not listed in yesterday’s announcement will be charged a 10% baseline tariff. The executive order notes that the administration could modify tariff rates further in the future, depending on whether trade agreements are reached or if the administration determines the circumstances warrant it. 
    • “In a separate announcement, the administration raised tariffs on goods from Canada to 35%, effective Aug. 1. The tariff would not apply to Canadian goods that qualify for duty-free exemptions under the trade agreement between the U.S., Mexico and Canada.”
  • and
    • The Centers for Medicare & Medicaid Services Aug. 1 released the fiscal year 2026 final rule for inpatient rehabilitation facilities. The rule will increase payments by 2.6% overall, which includes a 3.3% market basket update reduced by a 0.7 percentage point productivity adjustment. CMS also finalized a decrease in the outlier threshold, from $12,043 to $10,062. For the IRF Quality Reporting Program, CMS finalized removal of four patient assessment data elements and removed the COVID-19 vaccination measures for both patients and health care personnel. Payment changes are effective Oct. 1, 2025.
  • and
    • “The Centers for Medicare & Medicaid Services Aug. 1 issued a final rule for the inpatient psychiatric facility prospective payment system for fiscal year 2026. CMS will increase IPF payments by a net 2.4%, or $70 million, in FY 2026 compared to FY 2025. The payment update reflects a market-basket update of 3.2% minus a productivity adjustment of 0.7 percentage points, as well as an additional cut of 0.1% due to the updated outlier threshold. In addition, the agency will increase the adjustment factors for IPFs with teaching status and in rural locations and recognize increases to IPF teaching caps as required by law. For the IPF Quality Reporting Program, CMS will remove three measures related to health equity and one on COVID-19 staff vaccination and revise the reporting period for its emergency department visit following IPF discharge measure.”
  • Per an HHS news release,
    • “Health and Human Services Secretary Robert F. Kennedy, Jr. today announced additional repeals of federal policy that financially rewarded hospitals for reporting staff vaccination rates – an incentive that was coercive and denied informed consent.
    • “Medical decisions should be made based on one thing: the wellbeing of the person – never on a financial bonus or a government mandate.” said Secretary Kennedy. “Doctors deserve the freedom to use their training, follow the science, and speak the truth-without fear of punishment.”
    • “The policy, established under the Biden administration’s Centers for Medicare & Medicaid Services (CMS) inpatient payment rule, tied hospital reimbursement to staff vaccination reporting. The data was published on CDC’s National Healthcare Safety Network as a tool for public shaming, not public health.”
  • The Washington Post reports,
    • “Some obese Americans on Medicare and Medicaid could get access to expensive weight loss drugs under a five-year experiment being planned by the Trump administration.
    • “Under the proposed plan, state Medicaid programs and Medicare Part D insurance plans would be able to voluntarily choose to cover Ozempic, Wegovy, Mounjaro and Zepbound for patients for “weight management” purposes, according to Centers for Medicare and Medicaid Services documents obtained by The Washington Post. * * *
    • “The experiment is expected to start in April 2026 for Medicaid and January 2027 for Medicare plans, according to the documents. It will be conducted through a testing lab called the Center for Medicare and Medicaid Innovation (CMMI), which tries new ways of paying for health care with the goal of lowering costs and improving care.”
    • The pilot should shift some costs from the FEHB Program to Medicare.
  • NCQA today revealed its HEDIS changes for Measurement Year 2026.

From the Food and Drug Administration,

  • MedTech Dive tells us,
    • “The Food and Drug Administration has cleared Cardiosense’s CardioTag wearable heart monitor, the company said Wednesday.
    • “CardioTag captures electrocardiogram, photoplethysmogram and seismocardiogram signals, plus heart and pulse rate, to enable physicians to noninvasively monitor a patient’s cardiac function.
    • “Cardiosense is planning to combine the data with AI models for cardiovascular parameters. The company has published a paper on a pulmonary capillary wedge pressure algorithm.”

From the judicial front,

  • Bloomberg Law reports,
    • “Trump administration restrictions on transgender care for minors have drawn a new legal challenge from a coalition of states.
    • “The lawsuit, filed Friday in the US District Court for the District of Massachusetts, argues that what it calls President Donald Trump’s “Denial of Care” executive order and subsequent implementation actions are trying to block the provision of health care for transgender youth to minors without any basis in federal law. 
    • “No federal law prohibits, much less criminalizes, the provision or receipt of gender-affirming care for transgender adolescents,” the lawsuit said.
    • Michigan, Massachusetts, Nevada, New Jersey, and New Mexico are among the states listed on the lawsuit. Also among the plaintiffs is Pennsylvania Gov. Josh Shapiro, a Democrat whose attorney general is a Republican.
    • The case is Mass. v. Trump, D. Mass., No. 1:25-cv-12162, 8/1/2025.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many Mid-Atlantic, Southeast, Southern, and West Coast states. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP adds,
    • COVID-19 activity is picking in the United States, according to the latest update from the Centers for Disease Control and Prevention (CDC). Although wastewater levels are low nationally, the CDC said cases are rising in many Mid-Atlantic, Southeastern, Southern, and West Coast states. According to the CDC COVID Data Tracker, test positivity for the week ending July 26 rose to 6.5%, up from 4.9% the previous week, while the rate of COVID-related emergency department visits for all ages climbed from 0.6% to o.7%. The percentage of US deaths from COVID rose from 0.3% to 0.4%. Seasonal flu and respiratory syncytial virus (RSV) activity remain low. The CDC also noted that respiratory infections caused by Mycoplasma pneumoniae remain elevated in some parts of the country.
  • and
    • “The 2024-25 COVID mRNA vaccines targeting JN.1 were highly effective in protecting against hospitalization and death for at least 4 months in a cohort of Danish citizens aged 65 and older by October 1, 2024. The new analysis estimating the vaccine efficacy (VE) of last season’s COVID vaccines was published earlier this week in The Lancet Infectious Diseases. 
    • “In total, 894,560 Danish residents were included in the study, with a median age of 76. By Jan 31, 2025, 820,229 (91.7%) of the participants had received a JN.1 vaccine. Among those without updated JN.1 vaccination (74,331), 278 COVID-19 hospitalizations and 84 deaths were observed during 25.6 million person-days. 
    • “In contrast 197 COVID-19 hospitalizations and 56 deaths in 62.9 million person-days were observed in residents who received Pfizer’s Comirnaty (among 728,868 recipients). And 10 COVID-19 hospitalizations and 1 death were observed during 9.2 million person-days in those vaccinated with Moderna’s Spikevax vaccine (91,461 recipients).”
  • Per Medscape,
    • “Does drinking alcohol increase the risk for pancreatic cancer? Researchers have long suspected it does, but the evidence has remained inconsistent.
    • “Now, a global study of more than two million people is firming up the case that a link exists.
    • “The study, which pooled data from 30 prospective cohorts, found that daily alcohol intake was associated with a “modest” increased risk for pancreatic cancer in both women and men, regardless of smoking status.”
  • Per Genetic Engineering & Biotechnology News,
    • “The Notch signaling pathway plays a pivotal role in determining cell fate, especially in the development and function of T cells. But mimicking this highly mechanical, contact-dependent pathway in the lab has been a formidable challenge—until now.
    • “A team of researchers at Boston Children’s Hospital and Harvard Medical School has developed a solution by designing a synthetic protein using AI-powered tools to activate Notch signaling. These soluble protein agonists can replicate Notch activation in suspension culture, opening the door to scalable, precision-controlled T-cell therapies.
    • “The study published in Cell, “Design of Soluble Notch Agonists that Drive T Cell Development and Boost Immunity” was led by George Daley, MD, PhD, Dean of Harvard Medical School and co-founder of the Stem Cell and Regenerative Biology Program at Boston Children’s Hospital. The researchers used AI-based computational design tools to build synthetic molecules with similar geometry and multivalency required for Notch activation.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “If you’ve followed health insurance earnings over the past few weeks, you might be experiencing some whiplash. 
    • “Four of the biggest players — top names like UnitedHealth Group and Elevance — lowered their profit expectations for the year, while two others — Humana and CVS Health — raised them. One, Cigna, reaffirmed its previous outlook. 
    • “It turns out, the returns health insurers saw in the first half of 2025 were largely determined by what they did in the previous two years. Some saw the writing on the wall early and shook off unprofitable plans in specific counties, emerging with more stable, albeit slimmer, profiles. Others weren’t as proactive, and they’re now paying the price. 
    • “It’s sort of like where you came from in ’24 matters,” said Brad Ellis, a senior director at Fitch Ratings who leads its health insurance sector. “None of the companies I would say are doing really well, but it’s just a matter of who is doing less bad.” 
    • “Another big factor at play is everything insurers do besides insurance. Most of them now have booming pharmacy benefit managers and care delivery segments that in some cases draw more revenue and are more profitable than their insurance businesses. 
    • “One thing that unites them all: They are footing bigger bills as people get more medical services than before, and those services get more expensive. It’s happening across Affordable Care Act plans, Medicaid, and Medicare Advantage, the private form of Medicare. Some of the higher expenses stem from higher prices from hospitals and providers’ ramped-up coding tactics.”
  • World at Work adds,
    • “Healthcare costs in 2026 are expected to continue to trend upward within employer-provided coverage plans, according to recent reports from consulting firms PwC and Mercer. And, as in years past, the primary employer challenge will be how to best mitigate those expected higher costs.
    • “For instance, PwC reported in a recent survey that the overall increase in the cost of healthcare, or the “medical cost trend,” may be around 8.5% or higher for 2026. Medical cost trend is a metric that shows how much a health plan’s medical claim costs would change if it kept its plan design the same. The projection is similar to what PwC analysts have seen for the U.S. group health market so far for 2025. 
    • “PwC also noted that one force that could increase employers’ health plan costs are looming federal spending cuts to Medicaid and Affordable Care Act (ACA) subsidies as a result of the recently signed H.R. 1 (also known as the “One Big Beautiful Bill Act”).
    • “In its survey, Mercer found that as health plan costs continue to increase, more employers intend to change or reduce their 2026 benefit offerings to control spending.
    • “For example, 51% of respondents said they’re “likely” or “very likely” to make plan changes that would shift more costs to employees, such as raising deductibles or out-of-pocket maximums. The percentage increased from 45% in 2024.”
  • Here is a link to Milliman’s July 2025 report titled Commercial health insurance: Detailed 2023 financial results and emerging 2024 and 2025 trends.
  • Healthcare Dive lets us know,
    • “UnitedHealth announced on Thursday it will replace its CFO, another significant executive change for the healthcare behemoth as it mounts a financial turnaround. 
    • “Wayne DeVeydt, most recently a managing director and operating partner at investment firm Bain Capital, will take up the CFO role on Sept. 2, according to a press release. 
    • “John Rex, the company’s CFO since 2016, will become a strategic advisor to CEO Stephen Hemsley, who returned to the top job in May after UnitedHealth’s previous CEO stepped down.”
  • Beckers Hospital Review points out the 20 highest, lowest paid physician specialties | 2025.
  • The Wall Street Journal reports,
    • “President Trump demanded pharmaceutical companies lower drug prices, aligning them with other advanced countries.
    • “Analysts believe the proposals’ impact may be limited, facing legal challenges and requiring Congressional approval.
    • “PhRMA opposed the plan, advocating for addressing healthcare middlemen and urging other countries to pay their fair share for drug innovation.”
  • Per BioPharma Dive,
    • “Biotechnology companies specializing in psychedelics research saw their share prices rise after rumors of a billion-dollar acquisition hinted that big pharma is now more open to betting on this area of drug development.
    • “Bloomberg News reported early Thursday that AbbVie is in talks to buy privately held Gilgamesh Pharmaceuticals. If agreed to, the deal would hand AbbVie a small slate of experimental therapies for depression, anxiety and mental health conditions. Gilgamesh’s most advanced drug, code-named GM-2505, works by latching onto a brain protein known to interact with psychedelics like LSD and psilocybin.” * * *
    • “Analysts note, too, the inroads psychedelics are making with drug regulators. Martin Makary, commissioner of the Food and Drug Administration, and Robert F. Kennedy Jr., head of the Department of Health and Human Services, both support speeding up the testing — and possible approval — of psychedelics. The FDA, under former president Joe Biden, also issued guidance in 2023 for psychedelic drug developers.”

Thursday report

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

From Washington, DC,

  • The Centers for Medicare and Medicaid Services finalized three payment rules on Thursday, all of which will take effect on October 1, 2025, according to the American Hospital Association News.
    • “The Centers for Medicare & Medicaid Services July 31 issued a final rule that would increase Medicare inpatient prospective payment system rates by a net 2.6% in fiscal year 2026, compared with FY 2025, for hospitals that are meaningful users of electronic health records and submit quality measure data.    
    • “This 2.6% payment update reflects a hospital market basket increase of 3.3% as well as a productivity cut of 0.7%. This update also reflects CMS’ proposal to rebase and revise the market basket to a 2023 base year. In addition, the rule includes a $2 billion increase in disproportionate share hospital payments and a $192 million increase in new medical technology payments. Overall, it would increase hospital payments by $5 billion in FY 2026 as compared to FY 2025. 
  • and
    • The Centers for Medicare & Medicaid Services today finalized a 3.0% payment update for long-term care hospitals for fiscal year 2026 relative to FY 2025. This includes a 3.4% market basket update, reduced by a 0.7 percentage point productivity adjustment. In addition, although CMS will increase the outlier threshold from $77,048 to $78,936, it says outlier payments will increase by 0.3%.  
  • and
    • “The Centers for Medicare & Medicaid Services today issued a final rule for the skilled nursing facility prospective payment system for fiscal year 2026. The rule will increase aggregate payments by 3.2%, which reflects a 3.3% market basket update, a 0.7 percentage point cut for productivity, and an increase of 0.6 percentage points for the market basket forecast error for FY 2024.”
  • STAT News reports,
    • “President Trump escalated his demands that pharma companies lower U.S. drug prices in line with what other countries pay, sending letters to 17 major drug companies Thursday that called on them to take actions by Sept. 29.
    • “He specifically asked the firms to: provide their full portfolio of drugs to Medicaid patients at prices in line with what other major wealthy countries pay; guarantee that new drugs will be offered to Medicare, Medicaid, and commercial payers at those lower prices; implement direct-to-consumer distribution models for “high-volume, high rebate” drugs; and repatriate increased revenues that they earn abroad back to the U.S. 
    • “The companies he sent letters to were: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, Gilead, EMD Serono, Pfizer, Novo Nordisk, AstraZeneca, Amgen, Genentech, Johnson & Johnson, GSK, Merck, Regeneron, Sanofi, and Eli Lilly.”
  • The AHA News tells us,
    • “The Department of Health and Human Services today issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities. 
    • “The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare & Medicaid Services’ Medicare Drug Price Negotiation Selected Drug List regardless of payer. 
    • “HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date.” 
  • Per an HHS news release,
    • “Susan Monarez, Ph.D., was sworn in today as Director of the Centers for Disease Control and Prevention (CDC) by U.S. Health and Human Services Secretary Robert F. Kennedy, Jr.”
  • The Departments of Labor, HHS, and Treasury as well as OPM issued CAA 2021 and ACA FAQs (No. 71, government link) Thursday morning. The FAQs brings us up to date on the application of the Fifth Circuit’s Texas Medical Association case to QPA calculations and reiterates that “The maximum annual limitation on [in-network] cost sharing for the 2026 plan year will be $10,600 for self-only coverage, and $21,200 for other than self-only coverage.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use. These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients who use opioids over long period.”
  • The New York Times reports,
    • “The Food and Drug Administration on Wednesday approved a medical device that offers new hope to patients incapacitated by rheumatoid arthritis, a chronic condition that afflicts 1.5 million Americans and is often resistant to treatment.
    • “The condition is usually managed with medications. The device represents a radical departure from standard care, tapping the power of the brain and nervous system to tamp down the uncontrolled inflammation that leads to the debilitating autoimmune disease.
    • “The SetPoint System is an inch-long device that is surgically implanted into the neck, where it sits in a pod wrapped around the vagus nerve, the longest nerve in the body. The device electrically stimulates the nerve for one minute each day.
    • ‘The stimulation can turn off crippling inflammation and “reset” the immune system, research has shown. Most drugs used to treat rheumatoid arthritis suppress the immune system, leaving patients vulnerable to serious infections.”

From the public health and medical research front,

  • STAT News reports,
    • “U.S. kindergarten vaccination rates inched down again last year and the share of children with exemptions rose to an all-time high, according to federal data posted Thursday.
    • “The fraction of kids exempted from vaccine requirements rose to 4.1%, up from 3.7% the year before. It’s the third record-breaking year in a row for the exemption rate, and the vast majority are parents withholding shots for non-medical reasons.
    • “Meanwhile, 92.5% of 2024-25 kindergartners got their required measles-mumps-rubella shots, down slightly from the previous year. Before the Covid-19 pandemic, the vaccination rate was 95% — the level that makes it unlikely that a single infection will spark a disease cluster or outbreak.” * * *
    • “In the last decade, the percentage of kindergartners with medical exemptions has held steady, at about 0.2%. But the percentage with nonmedical exemptions has risen.”
  • BioPharma Dive lets us know,
    • “Eli Lilly’s popular diabetes drug Mounjaro proved about as effective as its older medicine Trulicity in protecting heart health in the largest and longest clinical trial of the newer GLP-1 therapy to date.
    • “According to summary results released by Lilly Thursday, Mounjaro met the main goal of the head-to-head study, which enrolled more than 13,000 people with Type 2 diabetes and heart disease and ran for nearly five years.
    • “While Mounjaro’s benefit wasn’t great enough for researchers to declare it superior to Trulicity, the rate of all-cause mortality was 16% lower for the newer drug, which in addition to stimulating the GLP-1 hormone receptor like Trulicity, also activates another known as GIP.”
  • Per MedPage Today,
    • “The past two respiratory virus seasons tallied at least 41 pediatric cases of influenza-associated acute necrotizing encephalopathy (ANE), a rare but severe neurologic condition, a multicenter case series showed.
    • “And most of these (76%) occurred in previously healthy children with no significant medical history, Andrew Silverman, MD, MHS, of Weill Cornell Medicine in New York, and colleagues from the Influenza-Associated ANE Working Group reported in JAMA.
    • “There hasn’t been any formal national surveillance of ANE to know whether the case counts for these two seasons are higher than normal, but that certainly seemed to be the case, Silverman said.
    • “Anecdotally, there seems to be an uptick in cases in the U.S.,” Silverman told MedPage Today. “From informally surveying all of these senior pediatric neurologists who have seen zero to one case in their career, now it seems like all of a sudden we’re forced to know more about ANE and how to treat it.”
    • “Mortality was high, at 27%, with 11 deaths. Patients died a median of 3 days from symptom onset, primarily from cerebral herniation (91%).”
  • Per Health Day,
    • “Blood-based colon cancer tests have become more common in recent years, offering a non-invasive option for screening
    • “Follow-up colonoscopy is recommended when a test result is ‘abnormal,’ but new data shows less than half of people following guidelines
    • “More must be done to educate people on the potentially life-saving importance of proper follow-up during colon cancer screening.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health reported earnings that beat Wall Street’s expectations and upgraded its projection for 2025, as its health-insurance business showed signs of recovery.
    • “The healthcare giant’s results underscore a split among health insurers. On one side are companies struggling this year with a surprise financial squeeze from higher-than-expected medical costs, a list that includes Centene, Molina Healthcare and the industry bellwether, UnitedHealth Group. 
    • “On the other side, Humana and CVS, which both had major financial challenges last year, say that the higher medical costs are largely in line with what they had projected. Humana, like CVS, had second-quarter results that came in above analysts’ predictions, and raised its 2025 guidance.” * * *
    • “89.9%: The share of insurance premiums at Aetna spent on healthcare costs, known as the medical-loss ratio. It is a bit higher than last year’s 89.6%, but lower than the FactSet consensus of 90.5%.”
  • Beckers Payer Issues tells us,
    • “The Cigna Group reported a net income of $1.53 billion in the second quarter of 2025, compared to $1.55 billion during the same quarter last year, according to its July 31 financial report. 
    • “Total revenue was $67.2 billion for the three months ended June 30, up 11% year over year. Cigna said the increase was primarily driven by Evernorth Health Services and includes growth of existing client relationships and strong specialty pharmacy growth.” * * *  
    • “Cigna’s medical loss ratio was 83.2% in the second quarter, up from 82.3% during the same period last year. The company attributed the increase to expected higher stop-loss medical costs.” 
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • ICER announced today that it will assess the comparative clinical effectiveness and value of therapies targeting abnormal complexes of immunoglobulin for IgA nephropathy. These are expected to include sibeprenlimab (Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and budesonide (Tarpeyo®, Calliditas Therapeutics AB).  
    • The assessment will be publicly discussed during a meeting of the CTAF in February 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment

Midweek report

David Ermer–FDA, HSA, Medical / Rx research, Medicare, NIH, OPM, Patient safety, U.S. Healthcare–
  • Fedscoop interviews the new OPM Director Scott Kupor.
  • Kevin Moss, writing in Govexec, discusses how to avoid Medicare Part B late enrollment penalties.
  • The Wall Street Journal informs us,
    • “A Trump administration effort to block all funding that flows to outside health researchers was scrapped Tuesday evening after senior White House officials intervened, people familiar with the matter said. The funds—billions of dollars to study diabetes, cancer and more—are set to flow again, the people said.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services July 30 announced the creation of a “digital health ecosystem” that includes partnerships with health care organizations and technology companies, including Amazon, Anthropic, Apple, Google, and OpenAI. The initiative includes an interoperability framework with a goal of making health information easier to share between patients and providers. During an event at the White House, CMS announced voluntary criteria for data exchange to make data more accessible for health information networks and exchanges, electronic health records and technology platforms. More than 60 companies, including networks, payers, providers and app vendors signed pledges for the interoperability framework and agreed to meet certain objectives in the first quarter of 2026. The initiative will use secure digital identity credentials to obtain medical records from CMS-aligned networks that meet the agency’s data sharing criteria. Applications will be used to assist in delivering services such as diabetes and obesity management, conversational AI assistants and tools to replace paper intake forms with digital check-in methods.” 
  • Beckers Clinical Leadership points out four things to know about “a July report from HHS’ Office of Inspector General [concluding that’ hospitals failed to capture 49% of patient harm events because staff either did not consider them harmful or were not required to disclose them.”
  • BenefitsFocus shares HSA/HDHP trend identified by Benefitfocus’ 2025 Report.
    • “Benefitfocus found that Gen Z workers had the highest HSA-eligible HDHP participation relative to Millennials, Gen Xers, and Baby Boomers, and while overall participation in HDHP plans dipped slightly across all generations in 2025, Benefitfocus’ data showed that HSA-eligible HDHP participation increased among Gen Zers at a greater clip compared to Millennials, Gen Xers, and Baby Boomers from 2024 to 2025. 
    • “Benefitfocus also found that Gen Z workers had the lowest health care utilization. This makes some sense considering the fact that Gen Z are younger, and it’s likely that the younger you are, the less health care you may need to utilize. 
    • “However, Benefitfocus suggests that Gen Zers are under-utilizing health care because there is a gap in understanding (1) the benefits that are available to them, and also, (2) the various engagement tools that can help them access these benefits. 
    • “To this latter point, there are various tools and different programs that employers can deploy (1) to “engage” Gen Zers and (2) to better help Gen Zers understand that accessing high-value, cost-effective health care services (like preventive care, Telehealth services, and also Direct Primary Care services) is available to them for both short-term and long-term health needs.” 
  • Route 50 informs us,
    • “The Federal Communications Commission voted last week to require text messages to the 988 suicide and mental health crisis hotline to be georouted to local crisis centers based on where they are sent from.
    • “Previously, texts to 988, also known as Lifeline, had been routed to crisis centers based on the area code of the texter’s phone number. Mental health and crisis counseling experts had long warned the FCC that the discrepancy could limit Lifeline’s ability to connect those in crisis with local resources.”

From the Food and Drug Administration front,

  • Fierce Healthcare notes,
    • “Following the departure of Vinay Prasad, M.D., former head of the Center for Biologics Evaluation and Research (CBER), the FDA has already tapped someone else to temporarily fill his shoes.
    • “Freshly appointed Center for Drug Evaluation and Research (CDER) leader George Tidmarsh M.D., Ph.D., will now take on the role of acting director of CBER as well, according to an internal letter from FDA Commissioner Marty Makary, M.D., to staffers that was viewed by Fierce.
    • “Both departments fall under the FDA’s umbrella, with CDER covering most small-molecule and biological therapeutics while CBER oversees vaccines, cell and gene therapies and other blood products.”
    • “Tidmarsh is a veteran biotech executive who stepped into his federal leadership role at the beginning of last week.”

From the public health and medical research front,

  • STAT News reports,
    • “After patients go into remission, there may still be undetected cancer cells lying dormant through the body. Years or even decades after remission, these cells might activate and cause metastatic lesions in these patients. Certain respiratory infections, including the flu and Covid-19, may be among the triggers for this awakening, according to a new study.
    • “The study, which combined mouse experiments and epidemiological data, focused on breast cancer and was published Wednesday in Nature. It found the immune system’s response to viral infections in the lungs might be contributing to this cancer cell activation. The epidemiological analyses also found that patients in breast cancer remission were more likely to develop lung metastases if they tested positive for Covid.
    • “Taken together, experts told STAT that the findings reveal new insights on how metastatic disease occurs, although they also cautioned that the findings are early and may not yet be generalizable to all cancer types or even all subtypes of breast cancer.
    • “It’s an exciting link between acute infections and a reactivation of these dormant cells that can lead to cancer progression,” John Alcorn, an immunology professor at the University of Pittsburgh who was not involved in the study, told STAT. “Something that we once thought of as a two-week problem really has far-reaching effects beyond that.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have shown for the first time that a type of human papillomavirus (HPV) commonly found on the skin can directly cause a form of skin cancer called cutaneous squamous cell carcinoma (cSCC) when certain immune cells malfunction. cSCC is one of the most common cancers in the United States and worldwide. Previously, scientists believed HPV merely facilitated the accumulation of DNA mutations caused by ultraviolet (UV) radiation, usually the primary driver of cSCC. The findings were published today in The New England Journal of Medicine.
    • “This discovery could completely change how we think about the development, and consequently the treatment, of cSCC in people who have a health condition that compromises immune function,” said Andrea Lisco, M.D., Ph.D., of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “It suggests that there may be more people out there with aggressive forms of cSCC who have an underlying immune defect and could benefit from treatments targeting the immune system.”
    • “There are many different types of HPV, each tending to infect cells in a particular tissue and part of the body. The types of HPV found mostly on the skin—beta-HPV—are considered benign members of the skin microbiome that typically do not integrate into the DNA of skin cells. This contrasts with the alpha types of HPV, known to integrate into the DNA of mucous membrane cells and directly cause cancer of the genitals, anus, head and neck.”
  • The National Institute of Standards and Technology’s Taking Measure blog explains “How Nature’s Symmetry Might Help Us See Early Warning Signs of Cancer.”
  • Health Day reports,
    • “A dementia diagnosis typically arrives more than three years after the onset of symptoms
    • “That time lag jumps to an average of more than four years for folks battling early-onset dementias
    • “As drugs to fight dementias emerge, spotting the disease early will be crucial, researchers say.”
  • Also per STAT News,
    • “The decades-long push to develop an HIV vaccine has been riddled with setbacks. But researchers reported on Wednesday that they have managed to circumvent one of the longstanding challenges to developing protective shots against this complex and crafty virus.
    • “Scientists used a messenger RNA-based vaccine to reliably trigger antibodies that block viral infection in people and monkeys. The key, they found, was to use a vaccine that hid a portion of a key protein complex that pokes out of HIV’s surface, concealing a region that usually distracts the immune system from mounting a protective response. Only 4% of participants given a vaccine that exposed this part of the viral surface produced antibodies that could block infection; that jumped to 80% when this region wasn’t visible to the immune system.
    • “While researchers found that the vaccines they tested were generally safe and well tolerated, 6.5% of study participants developed hives, a finding also seen in another mRNA-based HIV vaccine study. These cases improved when participants took antihistamines, but scientists are looking into why this happened and how to avoid it.
    • “The findings were described in a pair of papers published in Science Translational Medicine. The authors note that this is the first time an HIV vaccine candidate has sparked antibodies that can neutralize infection in a large percentage of subjects.”
  • Per Medical Economics,
    • “Teens who regularly use e-cigarettes are just as likely to become cigarette smokers as their peers were in the 1970s, according to a new study co-led by researchers at the University of Michigan.
    • “The findings, published in the journal Tobacco Control, come despite dramatic declines in overall teen cigarette use over the last five decades. The study, a collaboration between the University of Michigan, Penn State University, and Purdue University, reveals that teenagers who had never used e-cigarettes had less than a 1-in-50 chance of smoking cigarettes weekly. In contrast, those who had tried e-cigarettes faced more than a 1-in-10 chance, while consistent e-cigarette users had nearly a 1-in-3 chance of also reporting cigarette use.
    • “The use of e-cigarettes and the proliferation of e-cigarettes have really disrupted those awesome trends and improvements,” said Jessica Mongilio, research fellow at the U-M School of Nursing and one of the study’s lead researchers. “For kids who have never used e-cigarettes, we do see those historic declines in risk. But for kids who do use e-cigarettes, it’s almost as if all of those policies and all of those perceptions have done nothing, and they’ve got a really high risk of smoking cigarettes.”
  • The Wall Street Journal reports,
    • “The use of ultrapotent synthetic opioids called nitazenes are spreading in Europe.
    • “Nitazenes, often from China, are mixed into heroin and other drugs. Even trace amounts can cause fatal overdoses, authorities warn.
    • “The U.S. has seen nitazenes in drug seizures, and the DEA warns Mexican cartels could use their relations with China-based suppliers to obtain nitazenes.” * * *
    • “The most common street nitazenes are roughly 50 to 250 times as potent as heroin, or up to five times the strength of fentanyl. They are likely much more prevalent than official statistics suggest, due to limited testing. Authorities say official death tolls are almost certainly undercounts.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Humana raised its 2025 guidance alongside the release of second quarter results that beat analyst expectations on Wednesday. It’s a bright spot for investors in the health insurance sector following dismal reports from other payers.
    • “Executives attributed the outperformance to higher-than-anticipated prescription volumes and more lucrative drugs dispensed in Humana’s pharmacy services division. The company also benefited from higher revenue in its insurance segment from unexpectedly strong Medicare Advantage membership retention.
    • “In addition, medical costs — though elevated — remained generally in line with what Humana had planned for coming into 2025, the company said. Humana’s stock was up 6% in Wednesday morning trading following the results.”
  • and
    • “Certain Universal Health Services growth targets for 2025 are looking less achievable after the for-profit health system reported another quarter of lackluster admissions on Monday.
    • “Behavioral health volumes in the second quarter were essentially flat, with adjusted admissions rising just 0.4%. It’s an improvement from last quarter, when behavioral health volumes declined. However, executives now consider UHS’ plans to grow adjusted behavioral patient days by 2.5% to 3% a long-term target, instead of a 2025 goal.
    • “CEO Marc Miller said one of the reasons UHS’ patient day target has remained “elusive” is payers’ growing preference for outpatient care, a trend that hasn’t favored UHS’ inpatient-heavy portfolio. To be competitive in the long term, UHS plans to focus capital spending on outpatient projects, building 10 to 15 freestanding behavioral health facilities per year.”
  • Fierce Healthcare points out,
    • “Teladoc Health announced its second-quarter earnings Tuesday, which revealed a 2% decline in revenue for the company. The company performed roughly 1% better than Wall Street analysts anticipated. 
    • “Teladoc reported $631.9 million in total revenue for the quarter that ended June 30, and a net loss of $32.7 million, or $0.19 per share. In the same quarter a year ago, the company posted a net loss of $838 million after it was hit with a $790 million goodwill impairment charge related to its virtual mental health offering, BetterHelp.
    • “Teladoc’s adjusted EBITDA margin was $69.3 million, down 23% year over year. Citigroup, Goldman Sachs Group, Bank of America and Truist Financial reduced their target prices for Teladoc in early July, MarketBeat noted.
    • “The integrated care portion of the business was the lone division with upside in the second-quarter earnings results. Integrated care brought in $391.5 million, up 4% compared to the same period last year. Its adjusted EBITDA margin was 14.7%.
    • “BetterHelp garnered $240.4 million in revenue, down 9% year over year. The tele-mental health brand had an adjusted EBITDA margin of 4.9%.” 
  • Beckers Hospital Review notes “Where hospital margins are climbing [and] dropping the most.”
    • “Margin growth or decline varied by region and hospital size. Here is the breakdown:
      • “South: 6.1 percentage points
      • “Midwest: 2.5 percentage points
      • “Northeast: 1.6 percentage points
      • “West: -2.2 percentage points
      • “0 to 25 beds: -1 percentage points
      • “100 to 199 beds: 4.2 percentage points
      • “300 to 400 beds: 0.8 percentage points
      • “500 or more beds: -0.2 percentage points’
  • The Wall Street Journal Bankruptcy Pro publication reports on “Hospital Failures Following Private-Equity Payouts Leave Patients, Taxpayers in Lurch. Communities where Steward Health Care and Prospect Medical had hospitals that closed are trying to fill gaps in healthcare and government budgets.”
  • WTW consulting’s Pulse offers the latest news on GLP-1 drugs.
    • “Utilization will continue to rise. A robust pipeline of new GLP-1 drugs later this year and in 2026 will bring more competition with the potential to drive lower unit costs.
    • “Government price negotiations for Medicare Part D plans could also put downward pressure on GLP-1 drugs in the commercial market.
    • “The drugs will likely gain other uses this year including metabolic dysfunction associated steatohepatitis, heart failure and peripheral artery disease, which will also contribute to more utilization.”

Tuesday report

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

From Washington, DC,

  • The Senate confirmed Susan Monarez to be Director of the Centers for Disease Control and Prevention today by a 51 to 47 vote. The AP adds,
    • “She holds a doctorate in microbiology and immunology from the University of Wisconsin and did postdoctoral research at Stanford University. Prior to the CDC, Monarez was largely known for her government roles in health technology and biosecurity.”
  • MedCity News tells us,
    • “On Thursday, a coalition of 28 healthcare organizations sent a letter to leaders in Congress calling on them to extend the Affordable Care Act enhanced premium tax credits, which are set to expire at the end of the year.
    • “The letter was addressed to John Thune, Senate majority leader; Chuck Schumer, Senate minority leader; Mike Johnson, speaker of the House; and Hakeem Jeffries, minority leader of the House. The letter was led by Keep Americans Covered and was signed by healthcare organizations including AHIP, Blue Cross Blue Shield Association, the American Medical Association, Kaiser Permanente, Families USA and more.” 
  • STAT News reports,
    • “Health secretary Robert F. Kennedy Jr. could “imminently” overhaul a key federal advisory panel that recommends which preventive services insurers must pay for, according to a person familiar with the plans. 
    • “The person said that federal health officials are actively vetting new members for the U.S. Preventive Services Task Force. David Mansdoerfer, an adviser to a Kennedy-aligned group of physicians, said he’s aware of people being considered for the panel, but declined to name them.” * * *
    • “Mansdoerfer added that the existing panel is “M.D. heavy” and a reconstituted panel is more likely to include “allied health professionals,” which are health care providers who aren’t nurses or physicians, like physical therapists and dietitians.” 
  • Following up on yesterday’s post about Medicare Part D, here is a link to the CMS guidance upon which the Wall Street Journal relied.
  • World at Work informs us,
    • “Health savings accounts (HSAs) have become a staple total rewards offering over the last decade, but a new study by the Employee Benefit Research Institute (EBRI) showed employees are still leaving the full value of these accounts on the table.
    • “The June 12 EBRI report pulled data from 14.5 million accountholders, containing more than $48 billion in total assets — roughly 40% of the entire HSA universe. The analysis revealed:
      • “Low balances. End-of-year balances increased in 2023 (the most recent analysis period) to $4,747 but are still modest compared with average out-of-pocket maximums for HSA-eligible health plans ($8,300 for individual coverage in 2025, $16,600 for family coverage)
      • “Low contributions. Relative to 2022, average HSA contributions increased in 2023. However, after adjusting for inflation, both employer and employee contributions were higher in the 2010s. Also, notably, the average combined HSA contribution was $760 less than the statutory maximum contribution for individuals and $4,660 less than the statutory maximum contribution for accountholders with family coverage.
      • “High withdrawals. More than half of accountholders withdrew funds, and the average distribution rose to $1,801.
      • “Low investment. Only 15% of accountholders invested in assets other than cash. 
    • EBRI found that, essentially, employees use HSAs as specialized checking accounts rather than investment accounts, and in doing so, miss out on the triple tax advantage available if they maximize contributions, minimize withdrawals and invest their balances.
    • “The good news is that, here we are 20-plus years after HSAs launched, and they’ve become pretty standard. They’re a typical plan offering from most employers of all sizes — not just large or small companies, or in certain industries,” said Alexander Domaszewicz, a principal and healthcare consultant at advisory firm Mercer. “If we live long enough, we’ll have healthcare expenses, and we want to be prepared for that. But while awareness and visibility of HSAs have grown, they’re still intimidating to folks.”
  • Beckers Payer Issues calls attention to recent No Surprises Act developments.
  • Federal News Network lets us know,
    • “The Trump administration is detailing how it expects agencies to recruit more political appointees through the new “Schedule G” hiring category, while also reminding agencies that all non-career hires must be approved by the White House.
    • “The Office of Personnel Management on Tuesday outlined how agencies should adopt the federal employment classification President Donald Trump created earlier this month. Generally, the new Schedule G broadens agencies’ options for hiring political appointees, beyond the avenues already available to presidential administrations for picking their own staff members.
    • “In its guidance on Trump’s new hiring authority, OPM said agencies will have to run any Schedule G hires they want make by the White House for review and approval.
    • “As a matter of practice,” OPM said, agencies will have to send all their political hires to their White House liaison — a position that coordinates with the White House on hiring and retention of political appointees — before agencies can advance any Schedule G appointments.”

From the Food and Drug Administration front,

  • Bloomberg Law informs us,
    • “Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his handling of Sarepta Therapeutics Inc.’s gene therapy. 
    • “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,” Department of Health and Human Services spokesperson Andrew Nixon said in a written statement. 
    • “Prasad did not immediately respond to a request for comment about his departure.” 
  • The Washington Post reports,
    • “The Food and Drug Administration pushed Tuesday to restrict a synthetic opioid found in tablets, gummies and drinkable shots commonly sold in convenience stores.
    • “Health officials announced they will seek to add 7-OH — a potent substance synthesized from a compound in the kratom leaf — to the tier of controlled substances reserved for the most addictive drugs, such as heroin and LSD.
    • “The FDA, researchers and kratom companies have grown increasingly alarmed by the rise of 7-OH products they say are distinct from all-natural teas and powders derived from a leaf that grows on trees native to Southeast Asia.
    • “FDA Commissioner Marty Makary said at a news conference that the agency is not asking to restrict natural products made from kratom, which contains trace amount of the compound. In a report released Tuesday, the agency said it maintains concerns about kratom broadly but needed to act urgently on 7-OH because of its risk of sedation, nausea, breathing problems and addiction.”
  • From the judicial front,
    • Fierce Healthcare reports,
      • “A new law in Arkansas banning pharmacy benefit managers from owning pharmacies has been blocked by a federal judge, the latest development in one of the industry’s most-watched new pieces of legislation.
      • “Judge Brian Miller said the law may violate (PDF) the Commerce Clause in the constitution and is likely preempted by TRICARE, a health care program for military families. The state is barred from enforcing the law until final disposition, a ruling shows.
      • “Act 624 appears to overtly discriminate against plaintiffs as out of state companies and the state has failed to show that it has no other means to advance its interests,” said Miller, adding other enacted state laws already can properly restrict PBMs.
      • “Arkansas Attorney General Tim Griffin said he plans on appealing the decision, reported the Associated Press.
      • “We’re pleased with the Court’s decision to grant a preliminary injunction to stop the implementation of Act 624,” a CVS Health spokesperson said in a statement. “We continue to be focused on serving people in Arkansas and are actively looking to work together with the state to reduce drug prices and ensure access to pharmacies.”

From the public health and medical researach front,

  • KFF considers whether our country’s measles elimination status is at risk.
  • The Agency for Healthcare Research and Quality released a medical expenditures survey report titled “Healthcare Expenditures for Heart Disease among Adults Aged 18 and Older in the U.S. Civilian Noninstitutionalized Population, 2022.”
    • “In 2022, 7.8 percent of adults aged 18 and older were treated for heart disease, and men were more likely than women to have treated heart disease (8.4 % vs. 7.2%).
    • “Among age groups, the treated prevalence of heart disease was highest for those aged 65 and older (22.8%) compared to only 6.0 percent for adults aged 45-64, and 1.4 percent for adults ages 18-44.
    • “In 2022, healthcare expenditures to treat heart disease for adults in the US totaled $100.0 billion (with an average cost of $4,900 per adult with diagnosed and treated heart disease).
    • “The largest portion of heart disease expenditures were incurred through hospital inpatient stays (46.1%) and prescribed medications (20.5%).
    • “The majority of heart disease treatment costs were paid by Medicare (57.6%) and private insurance (24.2%).”
  • Per MedPage Today,
    • “The global incidence of liver cancer is projected to double by 2050.
    • “Sixty percent of liver cancers are preventable by controlling risk factors including hepatitis B and C, alcohol consumption, and MASLD.
    • “The Lancet Commission estimated that a 2-5% reduction in the age-standardized incidence rate of liver cancer could prevent up to 17.3 million new cases and save up to 15.1 million lives.”
  • Per Neurology Adviser,
    • “Urinary tract infections (UTIs) may be a trigger for myocardial infarction (MI) or stroke, with an increased risk for both within the first 7 days of infection, according to the findings of a study published in BMJ Open.”
    • “Growing evidence suggests that acute infection plays a role in the pathogenesis of cardiovascular disease.
    • “Researchers from Cardiff University in the United Kingdom conducted this self-controlled cases series using data from the Secure Anonymised Information Linkage (SAIL) Databank which houses nation-wide data from Wales. Patients (N=105,930) with MI (n=51,660) or stroke (n=58,150) between 2010 and 2020 were evaluated for general practitioner suspected or confirmed UTI before or after MI or stroke event. The peak risk period was defined as up to 90 days after UTI.
    • “The MI and stroke cohorts consisted of 63% and 49% men, with mean ages of 69 and 74 years for men and 77 and 79 years for women, respectively.”
  • STAT News reports,
    • “A major Alzheimer’s disease medical group is recommending that specialists may use certain blood tests to help diagnose patients with cognitive impairment in lieu of more complex and invasive tests, a move that could lead more people to get treated for the devastating disease.
    • “The Alzheimer’s Association, in its first clinical guidelines on blood biomarker testing, said Tuesday that tests that have over 90% sensitivity (ability to identify positive results) and 90% specificity (ability to identify negative results) can be used instead of current diagnostic methods like PET scans and cerebrospinal fluid tests.
    • “The group said that tests that have over 90% sensitivity and 75% specificity can be used to triage patients, meaning negative results rule can rule out Alzheimer’s with high probability but positive results should be confirmed with the standard diagnostic methods, given that these blood tests have a higher likelihood of false positives.
    • “The authors stressed that the guidelines should not be considered a substitute for a full clinical evaluation and that they apply only to people who are in the care of specialists and have already been confirmed to have cognitive impairment. The authors also noted that there’s wide variability in the blood tests on the market and that many do not meet the accuracy thresholds.”
  • Per Benefits Pro,
    • “Researchers at Cigna’s Evernorth Research Institute are seeing early signs that offering patients semaglutide and other GLP-1 agonists might cut the cost of managing mental health problems.
    • “Duy Do and two other Evernorth researchers found that using Ozempic or similar drugs to control blood sugar reduced use of office visits to treat depression by 13% and reduced use of office visits to treat anxiety by 15%.
    • “Use of GLP-1 agonists did not reduce use of emergency room visits or inpatient care for depression or anxiety, but the researchers say their work shows the need for understanding how GLP-1 agonist use affects people’s mental health and use of mental health services.
    • “Given the high economic burden of mental health disorders among patients with T2DM, further research is needed to confirm the clinical and cost-effectiveness of [GLP-1s] in reducing the overall health care burdens for this patient population,” Do and colleagues conclude.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “UnitedHealth Group anticipates its 2025 earnings to fall below expectations due to rising costs and operational issues.
    • “CEO Stephen Hemsley aims to restore UnitedHealth to high performance, projecting earnings growth for the coming year.
    • “UnitedHealth is facing industry upheaval with rising healthcare costs, government actions, and ongoing Justice Department probes.”
  • Modern Healthcare tells us,
    • “Humana is offering certain employees voluntary early retirement buyouts.
    • “Employees age 50 or older with at least three years of service are eligible for the program, although those working in certain business-critical areas will be ineligible, a company spokesperson said Tuesday. He said the window to apply for voluntary early retirement will be open for several weeks.
    • “The Louisville, Kentucky-based health insurer said the offers are part of ongoing evaluations Humana conducts to adjust staffing and drive organizational efficiency.”
  • Beckers Hospital Review lets us know,
    • “U.S. News & World Report released its 2025-2026 Best Hospitals rankings and ratings July 29, which included its list of 504 Best Regional Hospitals across 49 states and 95 metropolitan areas.
    • “The latest edition of Best Hospitals, now in its 36th year, evaluated more than 4,400 hospitals on measures such as risk-adjusted mortality rates, preventable complications and level of nursing care.” 
    • The article lists the no. 1 ranked hospitals in each eligible state.
  • Cardiovascular Business points out the best heart hospitals according to U.S. News and World Report.
  • Fierce Healthcare informs us,
    • “Earlier this year, CVS Health announced that it would invest $20 billion in improving the consumer experience and making the healthcare journey simpler.
    • “Now, its health benefits arm, Aetna, is unveiling its new Care Paths program, which connects members who have certain health needs—launching with diabetes, joint health and maternity care—to a more personalized view of their benefits and more directly with the care team supporting them. The platform is powered by artificial intelligence and offers users individualized recommendations for health and wellness programs related to their conditions as well as care kits when available.
    • “The goal, the insurer said, is to make members’ interactions with their health plans feel less transactional and instead more holistic. Aetna offered an exclusive look at the new offering to Fierce Healthcare.”
  • and
    • “Sword Health, a company that provides virtual physical therapy and mental health, is now offering an AI assistant for payers and providers to tackle operational and administrative tasks.
    • “The new AI division marks a notable expansion from the company’s core business of virtual care services like digital musculoskeletal care, pelvic health and movement health.
    • “The launch of the new division, called Sword Intelligence, marks a “pivotal evolution” in Sword Health’s strategy, according to the company.
    • “Sword Intelligence allows us to move beyond delivering care to our own members to enabling the entire healthcare industry to scale it efficiently and effectively,” Virgilio “V” Bento, founder and CEO of Sword Health, told Fierce Healthcare when reached via email.”
  • The Wall Street Journal further reports,
    • “Merck & Co. said it is embarking on a multi-year cost-savings plan, which includes cuts to its workforce and real-estate footprint, as it looks to redirect resources toward new product launches.
    • “The plan comes as the drug company on Tuesday logged lower revenue and sales in its latest quarter and narrowed its full-year guidance.
    • “The company said it expects the plan to result in $3 billion in annual cost savings by the end of 2027, which it plans to reinvest to support new products as well as its pipeline across multiple therapeutic areas.
    • “As part of the cost-savings plan, Merck expects to eliminate certain administrative, sales and research-and-development positions.
    • “The company didn’t disclose how many workers would be affected but said it would continue to hire employees in new roles across strategic growth areas of its business.
    • “Merck said it also would reduce its global real-estate footprint and continue to optimize its manufacturing network.
    • “The company expects the workforce cuts and real-estate reductions to result in annual cost savings of about $1.7 billion, which would be substantially realized by the end of 2027.”
  • and
    • “Novo Nordisk shares plunged after losing its lead in the weight-loss drug market to competitors like Eli Lilly.
    • “The company lowered its 2025 sales growth forecast due to copycat versions of Wegovy and slower Ozempic sales.
    • “Maziar Mike Doustdar was named chief executive, effective Aug. 7, succeeding Lars Fruergaard Jorgensen.”