Thursday report

FDA

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.”

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.” 

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.”

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Medicare drug plan premiums are expected to rise significantly next year due to rising costs and regulatory changes.
    • “A subsidy program that shielded seniors from rising monthly bills will be cut by about 40% in 2026.
    • “The premium increase will affect millions of seniors and may push more enrollees into Medicare Advantage plans.”
  • KFF tells us,
    • “Two new KFF analyses examine the latest data about Medicare Advantage, including trends in enrollment, premiums, out-of-pocket limits, supplemental benefits and prior authorization.
    • “The first analysis, focusing on enrollment trends, finds that 54% of eligible Medicare beneficiaries are enrolled in Medicare Advantage in 2025, though increases in enrollment slowed this year. One in five Medicare Advantage enrollees is in a special needs plan (SNP), reflecting a steady increase in recent years. And Medicare Advantage enrollment remains highly concentrated among a handful of insurance companies. 
    • “The second analysis finds that more than three quarters (76%) of enrollees in individual Medicare Advantage plans with prescription drug coverage pay no premium other than the Medicare Part B premium. The share of enrollees in plans offering a rebate against the Part B premium rose sharply from 12% in 2024 to 32% in 2025, but among these enrollees, about half are in plans that offer rebates of less than $10 a month while fewer (36%) are in plans that offer rebates of $50 or more per month. Prior authorization is most often required for expensive services such as skilled nursing facility stays (99%), Part B drugs (98%), inpatient hospital stays (acute: 96%; psychiatric: 93%) and outpatient psychiatric services (80%).” 
  • STAT News reports,
    • “No decision has been made on the future of an advisory panel [the U.S. Preventive Services Task Force] that decides which preventive care offerings, like cancer screenings, must be covered by insurers, a federal health department spokesperson said, after a [Wall Street Journal] report that health secretary Robert F. Kennedy Jr. is planning to oust all members. 
    • “But the report has alarmed the American Medical Association, which is calling on Kennedy to keep the panel’s members in place.” 
  • Modern Healthcare informs us,
    • “The Centers for Medicare and Medicaid Services wants to take another crack at creating a national provider directory in an effort to replace insurance company lists that are often riddled with errors.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz touted the idea at a meeting with health information technology executives in June. In a later post on the social media platform X, CMS described its goal as a “dynamic, interoperable directory that connects the data CMS has with what the industry knows, so we all work from the same map.” * * *
    • “The insurance industry would support a national provider directory “grounded in a robust public-private partnership,” the trade group AHIP said in a statement. At the AHIP 2025 conference last month, executives from Centene, Cigna and Aetna parent company CVS Health said their companies have met with CMS to discuss the concept.”
  • and
    • “Top Trump administration health officials are expected to bring tech companies to the White House this week to roll out a plan to encourage more seamless sharing of healthcare data, according to people familiar with the matter.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. and Centers for Medicare and Medicaid Services Administrator Mehmet Oz are expected to host executives at an event on Wednesday, said the people, who did not provide names of the attendees and asked not to be named because the details haven’t been made public.
    • “The plan was developed in coordination with the White House, building on a May effort by CMS to get public input on addressing barriers to sharing patient data.”
  • The American Hospital Association lets us know,
    • “The Substance Abuse and Mental Health Services Administration July 28 released its latest national survey on drug use and mental health. Among the findings, the percentage of adolescents aged 12 to 17 who had serious thoughts of suicide declined from 12.9% in 2021 to 10.1% in 2024. It also found a decline in adolescents who experienced a major depressive episode, dropping from 20.8% in 2021 to 15.4% in 2024. The survey also found that among the 61.5 million adults aged 18 or older in 2024 with any mental illness, 52.1% (32 million) received any mental health treatment in the past year. Among 14.6 million adults with serious mental illness in the past year, 70.8% (10.3 million) received mental health treatment. Due to changes to the survey questions and approach, not all estimates in the 2024 survey are comparable with 2023 and 2022 estimates, SAMHSA notes.” 
  • An HHS news release adds,
    • “The U.S. Department of Health and Human Services (HHS) has announced a $100M pilot funding opportunity to prevent, test for, treat, and cure Hepatitis C (HCV) in individuals with substance use disorder (SUD) and/or serious mental illness (SMI). This program is designed to support communities severely affected by homelessness and to gain insights on effective ways to identify patients, complete treatment, cure infections, and reduce reinfection by Hepatitis C (a liver disease caused by the Hepatitis C virus).
    • “HHS is delivering on our promise to the American people for a healthier, brighter future,” said HHS Secretary Robert F. Kennedy, Jr. “Through this pilot program, we are launching a comprehensive, integrated care model that not only cures HCV but also tackles critical risk factors like substance use, mental health challenges, and homelessness head-on.”
  • Beckers Hospital Review highlights five things to know about the foreign trade deals that the Trump administration has recently struck.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has given Sarepta Therapeutics a green light to resume shipping its gene therapy Elevidys to some patients with Duchenne muscular dystrophy, a little over one week after demanding the company halt sales over safety concerns. 
    • “In a statement Monday evening, Sarepta said it would begin shipments to treatment sites “imminently.” The resumption applies only to Duchenne patients who can still walk, which typically describes individuals who are younger and whose disease hasn’t advanced as far.”
  • and
    • “The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling the drugmaker it needs additional to review the company’s application.
    • “In a Friday statement, Bayer said the FDA did not raise any concerns around “general approvability” of the drug, called elinzanetant. Still, the agency extended its decision deadline by three months.”
  • Per MedTech Dive,
    • “Johnson & Johnson’s Ethicon unit has corrected disposable surgical stapler cartridges over a fault related to one death and one injury, the Food and Drug Administration said Friday.
    • “The company wrote to customers in April after learning that devices may activate but not cut or staple tissue. Additional steps are needed to open and remove locked devices from tissue. 
    • “Ethicon designed the stapler to prevent lockout events from harming patients. Still, the FDA said the lockout problem could cause life-threatening hemorrhage, surgical delay and death.”

From the public health and medical research front,

  • The New York Times reports,
    • “A combination of healthy activities including exercise, nutritious diet, computer brain games and socializing can improve cognitive performance in people at risk for dementia, according to a large new study.
    • “The study, conducted in five locations across the United States over two years, is the biggest randomized trial to examine whether healthy behaviors protect brain health.
    • “It confirms that paying attention to things like physical activity and vascular risk factors and diet are all really important ways to maintain brain health,” said Dr. Kristine Yaffe, an expert in cognitive aging at the University of California, San Francisco, who was not involved in the study.
    • “The results were presented on Monday at the Alzheimer’s Association International Conference in Toronto and published in the journal JAMA.”
  • The Washington Post adds,
    • “Any amount of walking is good for your health but picking up the pace has significant benefits — and it’s never too late for someone to train to walk faster.
    • “In an analysis published in PLOS One earlier this month, researchers found that frail older adults who deliberately walked faster saw a meaningful improvement in the distance they could travel when instructed to walk for six minutes straight. (Frailty is an age-related syndrome that affects 5 to 17 percent of older adults and is characterized by fatigue, a loss of strength and unexplained weight loss.)
    • “The results show that regardless of your age, the intensity of your workout can lead to greater improvements in physical function, said Daniel Rubin, the lead author of the analysis and an associate professor of anesthesia and critical care at the University of Chicago.”
  • Per the National Academy of Medicine,
    • “With more than half a million people globally living beyond the age of 100, it is time to rethink how health professionals and educators view older adults and the aging process. “Redefining aging” begins with transforming the mindset of current and future health professionals through targeted education. This involves encouraging them to reconsider how they address the unique needs of older adults and identifying those who can drive this change. Educators, health professionals, administrators, and policymakers must collaborate to reshape systems and attitudes. Together, they can build a well‑trained workforce that is not only prepared but motivated to address the complexities of aging that may include chronic disease and functional decline but also opportunities for growth and innovation. The barriers to achieving a change in mindset and solutions for overcoming challenges prompt a call to action. This paper is an entreaty by a group of interprofessional educators passionate about ensuring all health professionals are trained to meet the complex needs of older adults.”
  • MedPage Today tells us,
    • “Chronic obstructive pulmonary disease (COPD) affects at least 4.5% of those 18-49 years old, according to an analysis of U.S. cohorts * * * as reported in NEJM Evidence.”
    • “The early COPD group was more likely to be hospitalized or die from chronic respiratory disease, to develop heart failure, and to die before 75 years of age from any cause.
    • “Having a definition for early COPD might allow for studies to find ways to treat the disease and reduce its impact.”
  • The AHA News informs us,
    • “Five pediatric flu deaths were reported to the Centers for Disease Control and Prevention last week, pushing the total to 266 for the 2024-2025 flu season, according to the latest data. The total is the highest reported in any non-pandemic flu season since the agency began reporting it in 2004. The CDC said 90% of reported pediatric deaths this flu season have happened to children who were not fully vaccinated against the flu.”
  • The American Medical Association lets us know what doctors wish their patients knew about the impact of caffeine.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Bristol Myers Squibb BMY and Bain Capital are forming a new biopharmaceutical company focused on therapies for autoimmune diseases.
    • The new company will be created with $300 million in financing led by Bain Capital, including funds from the Canada Pension Plan Investment Board.
    • The company will begin with five potential treatments for autoimmune diseases in-licensed from Bristol Myers Squibb, which will retain 20% equity in the new company. Bristol Myers Squibb will also be entitled to royalties and milestones from the potential treatments.
    • Biotech executive Daniel Lynch, currently chairman of the board at Xilio Therapeutics XLO, will lead the new company as chief executive.
  • Per BioPharma Dive,
    • “GSK is turning to a China-based biotechnology company in search of its next blockbuster medicine, announcing Monday a broad drug making alliance with Hengrui Pharma that could be worth billions of dollars.
    • “GSK will pay Hengrui $500 million upfront to start the alliance. In return, it will receive rights outside of the greater China region and Taiwan to an experimental drug for chronic obstructive pulmonary disease as well as the potential to develop up to 11 other therapies for respiratory illnesses, immune disorders or cancer. If a variety of milestones are met, the deal could be worth up to $12 billion, plus royalties, GSK said.”
  • Beckers Payer Issues offers us six prior authorization updates that Beckers has reported since June 23.
  • Per an NIH news release,
    • “Researchers at the National Institutes of Health (NIH) have developed an artificial intelligence (AI) agent powered by a large language model (LLM) that creates more accurate and informative descriptions of biological processes and their functions in gene set analysis than current systems.
    • “The system, called GeneAgent, cross-checks its own initial predictions—also known as claims— for accuracy against information from established, expert-curated databases and returns a verification report detailing its successes and failures. The AI agent can help researchers interpret high-throughput molecular data and identify relevant biological pathways or functional modules, which can lead to a better understanding of how different diseases and conditions affect groups of genes individually and together.”

Thursday report

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • It’s worth noting that while the House of Representative has gone out of town for the August recess, the Senate will remain in session through next week.
  • The Wall Street Journal reports,
    • “Hospitals would be required to disclose how they make key decisions regarding extremely premature infants in a bill set to be introduced Thursday by Sen. Tom Cotton (R., Ark.).
    • “The legislation is in part prompted by a Wall Street Journal investigation last year that found mothers had been told no lifesaving measures were possible for their extremely premature infants, even though other hospitals nearby offered care for infants born at similar gestational ages.
    • “The Neonatal Care Transparency Act of 2025 would require hospitals to disclose publicly whether there is a minimal gestational age at which they offer active care for infants, rather than comfort measures before their death. While many hospitals require lifesaving measures to be given at 25 weeks’ gestational age or above, decisions on whether to attempt to save younger premature infants can vary by hospital or even doctor.”
  • Per Senate news releases,
    • “On Thursday, July 31, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on how to lower health costs and make health care more affordable for American patients.
      • “Title: Making Health Care Affordable: Solutions to Lower Costs and Empower Patients
      • “Date: Thursday, July 31, 2025
      • “Time: 10:00 AM ET/ 9:00 AM CT
      • “Location: 430 Dirksen Senate Office Building
      • “Click here to watch live”
  • and
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Thursday, July 31, 2025, at 10:00 AM ET to consider Bryan Switzer to be a Deputy United States Trade Representative (USTR), Gustav Chiarello III to be an Assistant Secretary of Health and Human Services (HHS), Michael Stuart to be General Counsel of HHS and Derek Theurer to be a Deputy Under Secretary of the Treasury.
      • “Title: Hearing to consider nominees for USTR, HHS and Treasury
      • “Witnesses: Bryan Switzer; Gustav Chiarello; Michael Stuart; Derek Theurer
      • “Date: Thursday, July 31, 2025
      • “Time: 10:00 AM ET
      • “Location: 215 Dirksen Senate Office Building
      • “Witness testimony, opening statements and a live video of the hearing will be available on www.finance.senate.gov.”
  • The Society for Human Resource Management tells us,
    • “The annual employee contribution limit for dependent care flexible spending accounts (FSAs) is increasing by 50% beginning next year, a change employers will want to communicate to employees as open enrollment season gears up. 
    • “The massive tax law that President Donald Trump signed July 4, known as the One Big Beautiful Bill Act, raises the limit for the pretax benefit account used to pay for eligible dependent care services to $7,500 for single individuals and married couples filing jointly, up from $5,000, and $3,750 for married couples filing separately, up from $2,500. The increase is effective beginning Jan. 1, 2026.
    • “Industry experts have been pushing for a higher contribution limit for years, calling the new increase long overdue. Although other limits, such as for health savings accounts and medical FSAs, are indexed for inflation and usually increase nominally each year, that’s not the case for dependent care FSAs. The current limits have been in place since 1986, except for a temporary increase during the pandemic.
    • “The increase is a “game changer for both working parents and businesses,” said Sara Redington, co-founder of The Best Place for Working Parents (BP4WP), a Fort Worth, Texas-based organization that recognizes employers supporting working parents.”
  • Tammy Flanagan, writing in Govexec, discusses “Why federal retirements are spiking this year. A sharp rise in retirement claims may be tied to fear instead of planning. If you’re eyeing the exit, make sure you’re not rushing into something you’ll regret.”
  • Per STAT News,
    • “Everyone agrees that diet is important to good health. And yet fewer than a third of medical students receive the recommended minimum of 25 hours of nutrition education, and more than half report receiving no formal education on the topic at all. 
    • “That’s why health secretary Robert F. Kennedy Jr. may be pushing on an open door with his plans to require medical schools to include nutrition education in their curricula or else lose federal funding. 
    • “One of the things we’re gonna do at NIH is to really give a carrot and stick to medical schools across the country saying you gotta put in your first-year curriculum a really good, robust nutrition course,” he said in a video posted to his Instagram account earlier this month. 
    • “Medical experts who spoke with STAT noted that there is no standardized curriculum for nutrition, and that it’s not yet clear what specifics Kennedy may attach to funding or what training medical schools might have to cut back to make room for nutrition courses. But they were on board with Kennedy’s general goal, noting that many nutrition and food policy experts have been calling for this kind of change for years. A 2022 House of Representatives resolution on the need for better nutrition education also won bipartisan support. And some medical schools have already taken steps to strengthen their offerings on the subject.”

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “Although Sarepta Therapeutics managed to defuse a brief stalemate with the FDA earlier this week, the U.S. drug regulator is reportedly going to put the company to work in order to affirm the safety of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys.
    • “Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News reported Thursday, citing an unnamed senior FDA official.
    • “It’s unclear what sorts of studies Sarepta would need to run to get Elevidys back in the agency’s good graces, or whether the company might need to conduct a new clinical trial, Endpoints noted. The publication said it was unable to independently verify the internal FDA discussions alluded to by the official.
    • “That said, no one at the FDA thinks the treatment should return to market based on current data, an anonymous FDA official told Bloomberg.”
  • and
    • “Danish dermatology specialist Leo Pharma has scored an FDA approval that makes its JAK inhibitor cream Anzupgo (delgocitinib) the first therapeutic in the U.S. specifically indicated for chronic hand eczema (CHE).
    • “The endorsement covers adults with moderate to severe CHE for whom topical corticosteroids either have been inadequate or are not suitable. In September of last year, Anzpugo became the first topical treatment for the condition approved in Europe.
    • “Dermatologists hailed the approval as a long-awaited treatment option for a condition that is often overlooked despite it affecting 1 in 10 adults in the world. A recent study commissioned by Leo and conducted by Ipsos showed that more than half of nearly 200 dermatologists who were surveyed were frustrated by the lack of progress in the indication.
    • “They said current therapeutics for moderate to severe atopic dermatitis—which are often prescribed to treat CHE—don’t sufficiently translate as treatments for moderate to severe CHE.”
  • The American Hospital Association News lets us know,
    • “The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula devices due to the potential for serious injury or death. Edwards identified incidents in which a 3mm to 4mm section of wire from the wire-reinforcement coil at the cannula tip was found to be exposed. The FDA said that some Femoral Arterial Cannula models are made of the same components as the OptiSite Arterial Perfusion Cannula models. Edwards has called for both products to be removed from wherever they are used or sold.”
  • Modern Healthcare reports,
    • “The Food and Drug Administration has classified Baxter’s recall of its Q-Link 13 mobile lift component as the most serious type, meaning it could lead to critical injuries or death if customers continue to use it.
    • “The Q-Link 13 is used with seven models of the company’s mobile lifts, which are used to move patients with limited mobility from one location to another or help with gait training.
    • “It’s an optional part that can be connected with a quick-release hook for sling bars, which hold the lifting sling. It could be attached incorrectly, possibly causing it to come loose and lead to a patient fall. This could result in serious injury to the patient or a caregiver trying to prevent the fall.
    • “This issue has potentially been associated with three serious injuries and one death, according to Baxter.”

From the judicial front,

  • The Northwest Arkansas Democrat Gazette reports,
    • “A federal judge on Wednesday said he will try to issue a ruling soon on whether a new state law banning pharmacies operated by out-of-state pharmacy benefit managers should be enjoined while the matter is being litigated in court.”
  • Govexec tells us,
    • “The Trump administration revealed to a federal court on Thursday the specific offices at which widespread layoffs were planned as of earlier this year, providing rare insight into the scale of its proposed reductions in force.” * * *
    • “The administration revealed the requests to the U.S. Court for the Northern District of California after Judge Susan Illston ordered their disclosure. Illston previously blocked the administration from moving forward with RIFs at all, but that injunction was overturned by the Supreme Court. The judge is now seeking to verify the legality of RIF plans on an agency-by-agency basis and sought information from 17 agencies the administration had told the Supreme Court were set to begin layoffs when Illston’s injunction took effect. 
    • “The Trump administration said the list in some cases undercounted the number of offices developing RIF plans and in others overcounted and has consistently maintained its plans were moving targets. An appeals court this week blocked another order from Illston requiring the administration to disclose to the court reorganization and RIF plans at every major agency, though those were not yet set to be made public.”  

From the public health and medical research front,

  • The AP reports,
    • “The fertility rate in the U.S. dropped to an all-time low in 2024 with less than 1.6 kids per woman, new federal data released Thursday shows.
    • “The U.S. was once among only a few developed countries with a rate that ensured each generation had enough children to replace itself — about 2.1 kids per woman. But it has been sliding in America for close to two decades as more women are waiting longer to have children or never taking that step at all. 
    • “The new statistic is on par with fertility rates in western European countries, according to World Bank data.
    • “Alarmed by recent drops, the Trump administration has taken steps to increase falling birth rates, like issuing an executive order meant to expand access to and reduce costs of in vitro fertilization and backing the idea of “baby bonuses” that might encourage more couples to have kids.
    • “But there’s no reason to be alarmed, according to Leslie Root, a University of Colorado Boulder researcher focused on fertility and population policy. 
    • “We’re seeing this as part of an ongoing process of fertility delay. We know that the U.S. population is still growing, and we still have a natural increase — more births than deaths,” she said.”
  • The Hill tells us,
    • “A new study suggests diets including eggs, especially the yolk, may help reduce the risk of Alzheimer’s disease.
    • “Published in The Journal of Nutrition, the study followed more than 1,000 U.S. adults and found that those who consumed more than one egg weekly had a 47 percent reduced risk of Alzheimer’s.
    • “Over an average follow-up of 6.7 years, 280 participants, or 27.3 percent, were diagnosed with Alzheimer’s dementia. Researchers found that 39 percent of the “total effect of egg intake” was linked to choline, a nutrient found in egg yolks known to support memory and brain function.
    • “Egg yolks also contain omega-3 fatty acids, which have neuroprotective benefits, further supporting brain health.”
  • The New York Times relates,
    • “Tens of millions of people in the United States struggle with obstructive sleep apnea, a condition that occurs when the throat muscles narrow during sleep, leading to temporary pauses in breathing that can cause people to snore and jolt awake, gasping for air.
    • “Poor sleep can leave people feeling exhausted, irritable and unfocused during the day. And if left untreated, sleep apnea can increase the risk for serious conditions like high blood pressure, Type 2 diabetes, heart attack and stroke.
    • “For decades, the primary treatment for sleep apnea has been continuous positive airway pressure (or CPAP). Before bed, those with the condition put on a face mask that is connected to a CPAP machine, which keeps the airway open by forcing air into it. The machines are effective, but many find them so noisy, cumbersome or uncomfortable that they end up abandoning them.
    • “Now, a more appealing option may be on the way, according to a news release from Apnimed, a pharmaceutical company focused on treating sleep apnea. On Wednesday, the company announced a second round of positive Phase 3 clinical trial results for a first-of-its-kind oral pill that can be taken just before bedtime to help keep a person’s airway open.” * * *
    • “Dr. Phyllis Zee, a sleep doctor and researcher at Northwestern Medicine who was not involved with the trial, said that if approved, the drug could transform the lives of many. That includes not only those who can’t tolerate CPAP machines, but also those who can’t — or prefer not to — use other interventions, such as other types of oral devices or weight loss medications. (Excess weight is a risk factor for sleep apnea.)”
  • Per STAT News,
    • “A Phase 3 study of AstraZeneca’s gefurulimab hit its primary and all secondary endpoints, teeing up talks with regulators about the potential blockbuster treatment for generalized myasthenia gravis, Fierce Biotech writes. AstraZeneca’s high hopes for the drug rest on the belief that the weekly, self-administered medicine can unlock an earlier, broader population than its existing gMG drug Ultomiris. In the study, people on gefurulimab performed significantly better on a gMG scale that assesses the ability to perform daily activities versus those on placebo, achieving the primary endpoint of the study.”
  • The U.S. Preventive Services Task Force released its Final Research Plan for Vision in Children Ages 6 Months to 5 Years: Screening.
  • Aunt Minnie adds,
    • “Changing national lung cancer screening guidelines in 2021 may have contributed to a surge in screening exams, but less lung cancer was detected in newly screened participants, and racial, ethnic, and sexual disparities persisted overall, according to a study published July 21 in the Journal of Thoracic Imaging.
    • “While numerous studies have examined the effects of the U.S. Preventive Services Task Force (USPSTF)’s 2021 lung cancer screening (LCS) guidelines on eligibility, this study focused on participation and lung cancer outcomes over the first 10 years of implementing an LCS program.” * * *
    • “Simply revising the guidelines increases eligibility but does not guarantee participation in LCS for these populations,” Lin and colleagues wrote. “These findings underscore the need for continued emphasis on active outreach and patient education efforts to promote LCS among racial and ethnic minority groups, as well as the further evaluation of how these initiatives impact participation and outcomes.”

From the U.S. healthcare business front,

  • Yahoo Finance lets us know,
    •  “Independence Blue Cross (IBX) is helping to improve recovery outcomes for its Medicare Advantage members after they leave the hospital and reduce costs with its Post-Acute Care Program. The program combines predictive analytics, proactive case management, and a focus on home-based recovery, to ensure members receive the right care at the right time after a stay at the hospital. Since its launch in July 2022, it has helped to improve CAHPS survey scores—a tool used to measure members’ experiences with health care services and strengthen health care in the U.S. It has also delivered $13 million in cost savings and earned the prestigious Blue Cross Blue Shield Association’s (BCBSA) North Star Award for its measurable impact.”
  • Per Beckers Payer Issues,
    • “Priority Health, the insurance arm of Grand Rapids, Mich. based Corewell Health, will become the governing member of Group Health Cooperative of Eau Claire, a Wisconsin-based health plan with more than 61,000 members.
    • “Both organizations expect the transaction to close by the end of 2025, pending regulatory approvals.
    • “The agreement will make Priority Health a four-state health plan with more than 1.3 million members across Michigan, Indiana, Ohio and Wisconsin.”
  • Per the AHA News,
    • “The AHA July 24 announced it is collaborating with health care technology leader Epic to help hospitals adopt tools that support the early detection and treatment of postpartum hemorrhage, a leading cause of maternal mortality. 
    • “The organizations have released a toolkit that includes dynamic risk assessments, clinical decision support and treatment guidance embedded in the electronic health record. With the proper permissions from applicable content providers, users of any EHR should be able to implement a similar set of tools. 
    • “The American Hospital Association and Epic share a deep commitment to improving health outcomes for moms and babies,” said Chris DeRienzo, M.D., AHA chief physician executive and a neonatologist. “This new collaboration amplifies our efforts to drive continuous improvement by sharing evidence-based resources to help reduce this tragic condition. It’s a natural extension of AHA’s Patient Safety Initiative, a collaborative data-driven effort to highlight and learn from patient safety progress at hospitals and health systems around the country.” 
    • “The AHA and Epic will support hospitals in their implementation journey with programming, resources and a space to learn from each other and engage with hospitals already seeing successful outcomes with items that are included in the toolkit.”
  • Healthcare Dive informs us,
    • “Labcorp has agreed to acquire certain ambulatory outreach laboratory assets from Community Health Systems, furthering an expansion push that has seen the testing services provider forge deals with a growing list of local and national health systems.
    • “The $195 million cash agreement with CHS includes patient service centers and in-office phlebotomy locations in 13 states, where Labcorp will assume some facility leases.
    • “Evercore ISI analyst Elizabeth Anderson, in a note to clients Tuesday, called the deal “very much in-line with [Labcorp’s] long-stated hospital management and outreach strategy where it continues to build a strong track record.”

Midweek update

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

From Washington, DC,

  • Roll Call reports,
    • “Senate Republicans say they are working on a bipartisan health package to lower drug and health insurance costs, a development that’s news to some Democrats who remain skeptical that their GOP colleagues will work with them.
    • “Sen. Bill Cassidy, R-La., is leading the talks, with a particular focus on more transparency from pharmacy benefit managers, so-called upcoding practices in Medicare Advantage and other health items.
    • “A group of Republican senators, including Lisa Murkowski of Alaska, are pushing to extend expiring health insurance subsidies for people who buy their own insurance on the marketplaces.
    • “Republicans are tight-lipped about the package, which is in the very early stages, said Sen. Michael D. Crapo, R-Idaho, who chairs the Senate Finance Committee.
    • “We’re going to have PBM legislation that hopefully will remain bipartisan, and there have been a number of other initiatives. I’m not going to start singling things out,” Crapo said Tuesday. “We are discussing everything that people want to look at as issues,” including Medicare Advantage, a private alternative to traditional Medicare, adding that he was disappointed certain changes weren’t addressed in the reconciliation package.”
  • Healthcare Dive offers more details on Tuesday’s Senate hearing about the Medicare Advantage program.
  • Mercer tells us,
    • “The Affordable Care Act (ACA) benchmark for determining the affordability of employer-sponsored health coverage will increase significantly for the 2026 plan year according to IRS Rev. Proc. 2025-25 — to 9.96% of an employee’s household income up from the 2025 plan-year level of 9.02%. This affordability percentage can affect individuals’ eligibility for federally subsidized coverage from a public exchange, as well as employers’ potential liability for shared-responsibility (or “play or pay”) assessments.” * * *
    • “Employers should review the required employee contribution for 2026 coverage if they plan to meet the ACA’s affordability limit under the applicable safe harbor. For the many plans using the FPL affordability safe harbor, the considerations differ for calendar- and non-calendar-year plans.”
  • Modern Health lets us know,
    • “Medicare may soon test a plan to equalize reimbursements for outpatient services regardless of where the care is provided.
    • “This foray into so-called site-neutral payment would begin next year and focus on physician-administered medications such as chemotherapy drugs. Hospitals would get paid less than they are now for providing those services.
    • “The plan, contained in the Hospital Outpatient Prospective Payment System proposed rule for 2026 that the Centers for Medicare and Medicaid Services issued last Tuesday, reflects growing interest in setting uniform Medicare rates for services across settings.”
  • The American Hospital Association New informs us,
    • The White House July 23 released an action plan with a series of more than 90 policy recommendations to expand the use of artificial intelligence. The plan follows a directive from the administration’s Jan. 23 executive order, “Removing Barriers to American Leadership in Artificial Intelligence.” The policy recommendations are aligned across three pillars — accelerating innovation, building American AI infrastructure, and leading in international diplomacy and security. The action plan recommends the launch of sector-specific efforts, including health care, to convene stakeholders to accelerate the development and adoption of national standards for AI systems. It also calls for testing AI system pilots in real-world settings across health care and other sectors through regulatory sandboxes and AI centers of excellence.
    • Other policy recommendations include removing onerous federal regulations that hinder AI development and deployment; expediting permits for building data centers and semiconductor facilities; expanding AI literacy and skills for education and workforce training; and bolstering critical infrastructure cybersecurity pertaining to AI.
  • and
    • “The Department of Health and Human Services July 23 announced it is recommending the removal of thimerosal from all U.S. flu vaccines. The announcement follows a recommendation last month by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The FDA posted a webpage yesterday allowing drug companies to indicate their interest in participating in a pilot voucher program that aims to cut product review times down to just one to two months. The agency will be choosing five companies in the first round.
    • “The FDA announced last month that it would launch this program to reward companies whose actions align with certain policy priorities, including addressing unmet public health needs, beefing up domestic production of drugs, and delivering more innovative cures.
    • “The webpage states that another “program priority” is increasing affordability, such as lowering drug prices in line with President Trump’s most favored nation policy.
    • “Critics say the voucher program raises concerns that the FDA is injecting politics into drug review decisions that should be centered around science, and that one to two months is not a sufficient amount of time to review new drugs.”
  • Per BioPharma Dive,
    • “Roche is pausing sales of the Duchenne gene therapy Elevidys in some countries outside the U.S. after partner Sarepta Therapeutics agreed Monday to a Food and Drug Administration request to do the same in the U.S.
    • “Roche said Wednesday it is temporarily and voluntarily halting shipments of the treatment in countries that reference the FDA’s approval of Elevidys in their local decision. The Swiss pharmaceutical company markets the gene therapy outside the U.S. under a 2019 alliance with Sarepta and will continue to ship Elevidys in countries that don’t rely on FDA decisions.
    • “The FDA asked Sarepta to stop shipping Elevidys following the deaths from acute liver failure of two teenagers treated with it earlier this year. Both Sarepta and Roche maintain the benefit-risk balance to treatment remains positive in younger patients who can still walk.”
  • Fierce Pharma points out,
    • “Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company’s multiple myeloma ambitions with a glimmer of hope.
    • “Following last week’s negative feedback from the FDA’s Oncologic Drugs Advisory Committee (ODAC), the agency was scheduled to make the final call on the drug’s use in patients with multiple myeloma who have received at least one prior line of therapy by July 23. 
    • “Now, the FDA has pushed back its decision date to Oct. 23, tacking on extra time to “review additional information provided in support of the application,” GSK announced Wednesday.”
  • The AHA News notes,
    • “The Food and Drug Administration July 22 released an early alert for Novum IQ large volume infusion pumps by Baxter. The company stated that the pump has potential for under infusion when transitioning to a higher flow rate. The FDA said Baxter has reported 79 serious injuries and two deaths associated with the issue as of June 27.”

From the judicial front,

  • Federal News Network reports,
    • “Details of the imminent reductions in force and staffing reorganizations planned across government will remain under wraps after an appeals court blocked a judge’s order for a list of those plans to be released.
    • “The Ninth Circuit Court of Appeals granted the Trump administration’s request for an emergency stay on U.S. District Court Judge Susan Illston’s order for the government’s lawyers turn over the dozens of RIF plans they said are ready for implementation.
    • “The appeals court’s decision means agencies can still move forward with any planned RIFs and staffing reorganizations without needing to divulge that information either to the court or to the public, at least for the time being.”
  • Per Bloomberg Law,
    • “Neurological Surgery Practice of Long Island, PLLC sued the Health and Human Services, Labor, and Treasury departments in April 2023, alleging the agencies failed to establish and enforce procedures to resolve surprise billing disputes as required by Congress under the No Surprises Act. The law requires insurers and doctors to resolve unexpected out-of-network bills through arbitration, rather than billing the patient.”
    • The district court ruled against the provider, and today the U.S. Court of Appeals for the Second Circuit affirmed (Dropbox link) the district court’s ruling (No. 24-1884).

From the public health and medical research front,

  • CBS News reports,
    • “Rich’s Ice Cream is recalling 110,292 cases of frozen dessert products across 23 states due to potential listeria contamination, which can lead to serious illness.
    • “The recall, which was first initiated in June, was recently updated to a Class II threat, meaning the product “may cause temporary or medically reversible adverse health consequences,” the U.S. Food and Drug Administration says.
    • “According to federal health officials, the products were distributed to Alabama, Arizona, California, Florida, Georgia, Illinois, Iowa, Louisiana, Massachusetts, Montana, Nebraska, Nevada, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin. They were also sold in Nassau, Bahamas.” * * *
    • “Customers can visit the Rich’s Ice Cream website for more information on product labels.”
  • The University of Minnesota informs us,
    • “Amid ongoing record post-elimination measles activity in the United States, four states have reported more measles cases, including Colorado, Iowa, New Mexico, and Wyoming.
    • “Meanwhile, in its weekly update, the US Centers for Disease Control and Prevention (CDC) added 10 more cases to the national total, which has now reached 1,319 cases.
    • “In early July, the United States passed its previous post-elimination record of measles cases, and though cases in the West Texas outbreak have declined steadily, smaller outbreaks and travel-linked cases continue to push the nation’s total higher. The surge in US measles activity is part of a global rise in cases made worse by dropping childhood immunization rates.
    • “The CDC said the number of affected states remained at 40, with the number of outbreaks holding at 29. So far, 87% of the nation’s cases are connected to outbreaks and 92% of affected patients are unvaccinated or have unknown vaccination status. Children ages 5 to 19 years old are the most affected age group, followed closely by adults ages 20 and older.”
  • Per STAT News,
    • “The H5N1 bird flu virus has historically extracted a heavy toll when it infects humans, with nearly half of confirmed cases ending in death over the past three decades. But of the 70 cases reported in the United States over the past 18 months, only a single death occurred, leaving experts puzzled at how to explain the phenomenon.
    • “A new study published Wednesday adds weight to an argument that the immunity people have developed to the virus that caused the most recent flu pandemic, an H1N1 virus that emerged in 2009, has induced some cross-protection that may be making it harder for H5N1 to infect people, and mitigating the severity of the ensuing disease when such infections occur.
    • “The paper, published in the journal Science Translational Medicine, reports on a number of studies done in ferrets, the closest animal model for what happens when humans are infected with influenza. It showed that while H5N1 is lethal to ferrets with no immunity to influenza, animals that have previously been infected with influenza A — either H3N2 or H1N1 — appear to have some protection when they are later exposed to the bird flu virus. The protection is particularly strong with H1N1.
    • “Seema Lakdawala, one of the authors of the study, said the findings provide hope that, should H5N1 — long considered a major pandemic threat — acquire the ability to spread easily to and among humans, the resulting pandemic might not be as disastrous as people have feared.”
  • MedPage Today tells us,
    • “A meta-analysis pooled data on dose-response associations between daily steps and a broad range of health outcomes.
    • “Increasing daily step counts above 2,000 was associated with risk reductions in mortality and cardiovascular, cancer, and other outcomes.
    • “A goal of 5,000 to 7,000 steps per day [not 10,000 steps] was deemed appropriate for achieving good health.”
  • HCPLive points out,
    • “A study found no significant differences in IBS symptom severity between gluten, wheat, and sham challenges, questioning the role of these ingredients as triggers.
    • “Despite findings, many patients continued a gluten-free diet, indicating psychological factors may influence symptom perception and dietary choices.”
  • HHS, FDA and USDA discuss their approach to ultra-processed food here.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Molina Healthcare is seeing sustained pressure as the insurer released its second quarter financial results.
    • “For the full year, the company anticipates a floor of $16.90 per diluted share and adjusted earnings to be at least $19.00 per diluted share. Earlier this month, the insurer warned medical cost pressures would affect adjusted earnings, lowering its target to $21.50 to $22.50 per share.
    • “Molina’s stock has dipped about 4% in after-hours trading.
    • “The current earnings pressure we are experiencing results from what we believe to be a temporary dislocation between premium rates and medical cost trend which has recently accelerated.,” said CEO and President Joseph Zubretsky in a statement. “We are still performing near our long-term target ranges, and nothing has changed our outlook for the long-term performance of the business.”
    • “Adjusted net income for the quarter is $5.48 per diluted share, similar to its preview from early July, for a decrease of 6% year-over-year.”
  • MedCity New tells us,
    • “Aeroflow Health, a health tech company, has teamed up with Cigna to provide virtual nutrition services to its members nationally, the company announced (Opens in a new window)on Tuesday.
    • “Asheville, North Carolina-based Aeroflow Health was founded in 2001 and offers an array of medical devices covered by insurance. The company has four lines: Aeroflow Breastpumps, Aeroflow Diabetes, Aeroflow Sleep and Aeroflow Urology. In addition to medical devices, it provides education and consultations. The company has partnerships with more than 1,000 insurance plans.
    • “Through the partnership with Cigna, Aeroflow Health will serve Cigna members who would “most benefit from nutrition interventions,” such as new mothers, those with diabetes or those with a chronic disease, according to the announcement. These patients will have access to registered dietitians, who can create personalized meal plans and provide tips to support their goals, such as boosting breast milk production, losing weight, reducing cholesterol or lowering the risk of heart disease.”
  • Healthcare Dive relates,
    • “Tenet Healthcare raised its 2025 financial guidance on Tuesday after releasing second-quarter earnings that showed year-over-year growth in revenue and adjusted earnings before interest, taxes, depreciation and amortization.
    • “The hospital operator now expects between $20.95 billion and $21.25 billion in revenue for 2025 on net income of $1.3 billion to $1.4 billion. Previously, Tenet projected $20.6 billion to $21 billion in revenue and $1.1 billion to $1.2 billion in income.
    • “Still, Tenet declined to answer questions on a Tuesday morning call with investors about the future financial impacts from the recently enacted “One Big Beautiful Bill” and potentially expiring Affordable Care Act exchange premium tax credits. Tenet’s stock declined about 15% by market close on Tuesday.”
  • Per Fierce Healthcare,
    • “Community Health Systems (CHS) shared word that it beat Q2 consensus estimates for both revenue and earnings, as well as news that CEO Tim Hingtgen will retire later this year.
    • “The public for-profit logged net operating revenues of $3.13 billion for the quarter, above the $3.02 billion estimate. That’s a 0.2% dip from the second quarter of 2024 though same-store net operating revenues rose 6.5%, reflecting divestitures the company underwent during the past year.
    • “The revenues outline a 7.4% year-over-year decline in admissions and an 8.3% decline in year-over-year admissions. However, same-store admissions rose by 0.3% while same-store adjusted admission fell by 0.7%.
    • “Net income attributable to stockholders was $282 million ($2.09 per share), as opposed to the $13 million net loss (-$0.10 per share) a year prior. Those decrease to a $0.05 net loss per share for Q2 2025 and $-0.17 net loss per share for Q2 2024 when excluding adjusting items related to early extinguishment of debt and asset sales.”
  • Beckers Hospital Review lets us know how health systems are staying ahead of drug shortages, and
    • “Pfizer and Bristol Myers Squibb have launched a direct-to-patient program offering their blood thinner Eliquis at a 40% discount for cash-paying patients. 
    • “The list price for Eliquis (apixaban) is $606 for a 30-day supply, but through the new program, the discounted price is approximately $242. More than 15 million Americans have prescriptions for Eliquis, according to a July 17 news release from Bristol Myers Squibb.” 
  • Optum, writing in LinkedIn, discusses the connection between AI and Rx benefits.
  • Per a news release, the Institute for Clinical and Economic Review (ICER) has issued its Draft Evidence Report on Treatment for Non-Cystic Fibrosis Bronchiectasis. The public comment period is now open until August 19, 2025; Requests to make oral comment during public meeting also are being accepted.
  • Per BioPharma Dive,
    • “A new biotechnology company debuted Wednesday with a hefty bankroll and an immunotherapy approach it claims has the potential to treat an array of tough-to-reach solid tumors.
    • “Called Dispatch Bio, the startup was formed in 2022 through a collaboration between Arch Venture Partners and the Parker Institute for Cancer Immunotherapy and built around technologies from scientific labs in Pennsylvania and California. It has since raised $216 million and developed a lead program that’s expected to enter clinical testing next year.
    • “Dispatch aims to deliver to cancer cells a sequence for a unique type of protein flag, known as an antigen, that it says can draw in specially engineered immune cells it plans to administer afterwards. The company believes its approach could yield a “universal” solid tumor treatment.”
  • and
    • “Abivax’s shares soared more than 500% on Wednesday after the company released positive Phase 3 results for its experimental ulcerative colitis medicine.
    • “The Paris-based biotech conducted two studies of its drug, obefazimod, in patients with moderately to severely active ulcerative colitis who didn’t receive enough relief from prior therapies. The 50 milligram dose of the medicine achieved a pooled 16.4% placebo-adjusted clinical remission rate at week 8, better than what was reported in Phase 2 testing, Abivax said late Tuesday.
    • “Researchers are now conducting a 44-week maintenance trial that should yield topline results in the second quarter of next year. If those results are also positive, Abivax plans to submit applications to U.S. and European regulators in the second half of 2026.”