Midweek update

NIH

Midweek update

David Ermer–CDC, COVID-19 vaccine, FDA, HSA, Medical / Rx research, NCQA, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Roll Call lets us know,
    • “House Republican leaders overcame a key procedural hurdle Wednesday evening, paving the way for floor consideration of the short-term stopgap funding measure they will need to pass with GOP votes later this week due to near-uniform Democratic objections.
    • “The chamber adopted the rule for floor debate on the bill on a 216-210 party-line vote.” * * *
    • “If the GOP bill can get out of the House, [Senate Minority Leader Chuck] Schumer [(D NY)] did offer an exit strategy of sorts on Wednesday night, offering a chance to look at a future commitment to deal with the expiring exchange subsidies once the CR passes rather than insist on changes to the bill now before the Sept. 30 deadline.
    • “Well look, we have two weeks [until October 1, the beginning of the new federal fiscal year]. They should sit down and talk to us, and we maybe can get a good proposal,” Schumer said. “We’ll sit down and negotiate if they will sit down and negotiate. We don’t have a red line, but we know we have to help the American people.”
    • “Republican leaders argue the current income thresholds to qualify for the tax credits are too high, and GOP senators are discussing lowering those in any extension.”
  • The Wall Street Journal reports,
    • “The former director of the Centers for Disease Control and Prevention [Susan Monarez] said she was fired after refusing to compromise her scientific integrity, testifying that Robert F. Kennedy Jr. asked her to preapprove vaccine recommendations and remove career scientists.” * * *
    • “Republican senators largely defended Kennedy and sought to cast Monarez as either untrustworthy or disloyal. Some questioned her hiring of lawyers who have represented Hunter Biden and other officials targeted by Trump.” 
  • Here is a link to the Senate Health, Education, Labor and Pension Committee’s website on this hearing.
  • Roll Call tells us, “Senate Republicans took a final procedural step Wednesday to speed up consideration of President Donald Trump’s lower-level nominees, setting up the confirmation of dozens of appointees as early as this week.”
  • Modern Healthcare points out,
    • “The House passed the Lower Costs More Transparency Act of 2023 with a PBM provision in the last Congress. The Senate, however, only advanced PBM bills as far as committee consideration. At the end of 2024, a version of all those measures was added to a popular bipartisan package of healthcare legislation, in part because of the work of Rep. Buddy Carter (R-Ga.), a pharmacist who pushed the PBM provisions with House leaders. 
    • “The bill was on the verge of passing as part of the annual government funding bill when leaders pulled it from consideration because then-presidential adviser Elon Musk and President Donald Trump raised objections. PBM industry groups argued the provisions aimed at them were giveaways to drug companies, which they say are ultimately responsible for drug prices.
    • “In an interview [with Modern Healthcare], Carter said he expects PBM legislation to pass this year. 
  • The Plan Sponsor Council of America notes,
    • “The PSCA’s 2025 HSA Survey shows employees are increasing contributions to their health savings accounts, and more are investing those assets when given the opportunity, leading to an increase in average account balances for the third consecutive year.
    • “PSCA’s seventh annual HSA survey, sponsored by HSA Bank, was conducted in the summer of 2025 and reflects responses from nearly 600 employers with an HSA program. The survey tracks employee and employer HSA trends from 2024.
    • “The survey shows that 20 percent of participants now invest their HSA savings, up from 18 percent the prior year. Also, two-thirds of employers now offer investments, a 12 percent increase over a two-year period.”
  • Per MedTech Dive,
    • “The Food and Drug Administration posted two notices on Tuesday warning about unauthorized blood pressure and infant monitoring devices sold over the counter.
    • “Many devices for measuring blood pressure and monitoring infant vital signs are currently sold over the counter without FDA marketing authorization, the agency said. The FDA recommended looking for an authorized device.
    • “The regulator has sent warning letters in the past to companies for selling monitoring devices without authorization.” 
  • From Justice Department news releases,
    • “Today, the Antitrust Division of the Department of Justice announces its collaboration with the Federal Trade Commission (FTC) to identify over 125 anticompetitive regulations in response to the President’s Executive Order on Reducing Anti-Competitive Regulatory Barriers. Under the leadership of President Trump, the Antitrust Division, in close coordination with the FTC and federal agencies, conducted a comprehensive, government-wide effort to identify and reform anticompetitive regulations that distort markets and stifle competition.
    • “In America we believe in free markets, not central planning by government regulators or powerful monopolists,” said Assistant Attorney General Abigail Slater of the Justice Department’s Antitrust Division. “Lowering barriers to entry by removing anticompetitive regulations will free America’s innovators and entrepreneurs to do what they do best: drive America’s future success.”
  • and
    • “An indictment was unsealed Friday charging two Florida men for their roles in a scheme to submit approximately $34.8 million in false and fraudulent claims to Medicare for medically unnecessary products. As part of the scheme, the defendants and their co-conspirators targeted thousands of Medicare beneficiaries and, through deceptive telemarketing, persuaded them to accept medical equipment that they did not need, such as orthotic braces and continuous glucose monitors.” * * *
    • “According to court documents, Kenneth Charles Kessler III, 42, of Miami-Dade County, Florida, and Michael Andrew Gomez, 42, of Broward County, Florida, are charged in connection with their ownership and operation of seven durable medical equipment (DME) supply companies based in Florida. Kessler and Gomez are accused of paying illegal kickbacks and bribes to purported marketing companies that targeted thousands of Medicare beneficiaries with deceptive and aggressive telemarketing campaigns. The indictment alleges that these marketing companies obtained the beneficiaries’ personally identifiable information and arranged for purported telemedicine companies to generate doctors’ orders for unnecessary medical equipment. Kessler and Gomez allegedly used these doctors’ orders to submit false and fraudulent claims to Medicare through their network of DME companies.
    • “Kessler and Gomez are both charged with conspiracy to commit health care and wire fraud, two counts of health care fraud, conspiracy to defraud the United States and to offer and pay health care kickbacks, and two counts of offering and paying kickbacks in connection with a federal health care program. If convicted, Kessler and Gomez each face up to 65 years in prison. A federal judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.”

From the Covid vaccine front,

  • STAT News informs us,
    • “Amid growing concern about Americans’ access to vaccines, the country’s biggest health insurance association said its member plans will continue to cover all shots recommended by a federal advisory committee prior to any changes by its new slate of appointees.
    • “America’s Health Insurance Plans’ announcement comes just ahead of the first meeting of the Advisory Committee on Immunization Practices’ 12 members handpicked by Health and Human Services Secretary Robert F. Kennedy Jr. The selection of the five newest members was announced Monday, and their meeting is Thursday and Friday. Experts have speculated that, among other steps, the panel will drop the existing recommendation that newborns receive the hepatitis B vaccine, a move that could lead to a resurgence of the virus and, as a result, liver disease and cancer.” * * *
    • “AHIP said its plans will cover all vaccines recommended by ACIP as of Sept. 1, 2025, and that there would be no cost sharing for patients through the end of 2026. That includes updated Covid-19 and influenza vaccines. Health insurers are required to make vaccines free if they are recommended by ACIP and adopted by the Centers for Disease Control and Prevention, but AHIP’s pledge ensures coverage will continue even if the new members change the panel’s recommendations.” 
  • The Washington Post warns that ACIP could increase the age at which senior citizens can receive the Covid vaccine without cost sharing from 65 to 75.
    • “The people familiar with the deliberations cautioned that the situation is fluid and rapidly changing. The recommendations would also need to be approved by the acting director of the Centers for Disease Control and Prevention before taking effect, and it’s unclear how quickly that would happen.
    • “If a senior is concerned about losing access to a coronavirus vaccine, “they should absolutely try to get vaccinated as soon as possible,” said Caitlin Donovan, senior director at Patient Advocate Foundation. But even if more restrictive guidelines take effect, she noted most seniors have an underlying condition such as diabetes, heart issues or a history with smoking. * * *
    • “If you can’t find an appointment quickly, contact your primary care physician and discuss your options,” Donovan said. “They should be willing to write you a prescription after considering your risk levels.”
  • The New York Times adds,
    • “Four Democratic-controlled Western states on Wednesday issued their own recommendations on who should get three common seasonal vaccines, a sharp rejection of efforts by Health Secretary Robert F. Kennedy Jr. to upend vaccine policy at the federal level.
    • The so-called West Coast Health Alliance — which includes health officials in California, Oregon, Washington and Hawaii — recommended that every resident 6 months and older receive the flu vaccine this fall. They also recommended that broad swaths of the population receive a Covid-19 shot, including pregnant women and all children from 6 months to 2 years old, and that R.S.V. vaccines be given to infants under 8 months and adults over 75, as well as to others with certain risk factors.
    • “The detailed guidance generally mirrors clinical recommendations that have been made by the federal government and by national medical organizations such as the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.”

From the public health and medical/Rx research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Today in its weekly update, the Centers for Disease Control and Prevention (CDC) said there are 1,491 confirmed measles cases in the United States this year in 42 jurisdictions, an increase of 37 cases in the past week. 
    • “Eighty-six percent of cases have been linked to one of 38 reported outbreaks, and roughly 12% of all case-patients have required hospitalization. 
    • “Last year the country recorded only 285 measles cases, and 2025 has been the worst year for measles activity in the United States since the virus was officially declared to be eliminated in 2000.”
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) has launched an effort to advance research on whole-person health and create an integrated knowledge network of healthy physiological function. Whole person health involves looking at the whole person—not just separate organs or body systems—and considering multiple factors that promote health. For example, a multicomponent lifestyle intervention including healthy diet, physical activity and stress management may improve multiple and interconnected aspects of health including cardiovascular (e.g. blood pressure), metabolic (e.g. glucose metabolism) and musculoskeletal function (e.g. muscle strength).
    • “Biomedical research is largely organized around the study of specific organs and diseases. In contrast, we do much less research on health itself, which is an integrated process involving the whole person,” said Helene M. Langevin, M.D., director of NIH’s National Center for Complementary and Integrative Health, which leads the NIH-wide program.
    • “The five-year research initiative will proceed in several stages, drawing from existing scientific knowledge to develop a complete, working model of healthy human physiology. It will build on the NIH Human Reference Atlas and the Human BioMolecular Atlas Program (HuBMAP) to connect the complex anatomy and function of the body’s different organs and systems into a single “map.”
    • “Future stages of the project will link common clinical measures, such as blood pressure, blood glucose and cholesterol, to major physiological functions. This initiative will also populate the framework with existing human data and ultimately build and test an interactive model of whole-person health.
    • “By organizing healthy physiological function into a whole-body knowledge network, researchers will be able to explore scientific questions about health in a new way,” said Dr. Langevin. “With our ability to acquire new scientific data at an increasingly dizzying speed, the importance of integrating and connecting new data to what we already know is greater than ever. The Whole Person Reference Physiome will lay a foundation for understanding the factors that drive declines in health and mechanistic pathways to health restoration.”
  • and
    • “Research supported by the National Institutes of Health (NIH) shows that repeated head impacts from contact sports can cause early and lasting changes in the brains of young- to middle-aged athletes. The findings show that these changes may occur years before chronic traumatic encephalopathy (CTE) develops its hallmark disease features, which can now only be detected by examining brain tissue after death.
    • “This study underscores that many changes in the brain can occur after repetitive head impacts,” said Walter Koroshetz, M.D., director of NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “These early brain changes might help diagnose and treat CTE earlier than is currently possible now.”
    • “Scientists at the Boston University CTE Center, the U.S. Department of Veterans Affairs Boston Healthcare System and collaborating institutions analyzed postmortem brain tissue from athletes under age 51. Most of them had played American football. The team examined brain tissue from these athletes, using cutting-edge tools that track gene activity and images in individual cells. Many of these tools were pioneered by the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. The researchers identified many additional changes in brains beyond the usual molecular signature known to scientists: buildup of a protein called tau in nerve cells next to small blood vessels deep in the brain’s folds.
    • “For example, the researchers found a striking 56% loss of a specific type of neurons in that particular brain area, which takes hard hits during impacts and also where the tau protein accumulates. This loss was evident even in athletes who had no tau buildup. It also tracked with the number of years of exposure to repetitive head impacts. The findings thus suggest that neuronal damage can occur much earlier than is visible by the currently known CTE disease marker tau. The team also observed that the brain’s immune cells, called microglia, became increasingly activated in proportion to the number of years the athletes had played contact sports.”
  • The American Journal of Managed Care informs us,
    • “Early-onset T2D is rising in the US, especially among underserved populations, with a worse cardiometabolic profile than later-onset cases.
    • “Financial hardships are more significant for younger adults, women, and minority groups with T2D, necessitating policies addressing medical and financial well-being.
    • NHANES data from 1999 to 2020 shows increased prevalence of early-onset T2D, highlighting the need for improved screening and diagnosis in younger adults.
    • ‘Study limitations include cross-sectional data, potential recall bias, and exclusion of institutionalized populations, affecting generalizability and causal inferences.’
  • Per Healio,
    • “Walking quickly for 15 minutes per day was associated with a significant reduction in all-cause mortality and CVD mortality, according to a cohort study published in American Journal of Preventive Medicine.
    • “Many studies have explored the health benefits provided by regular walking, including recent findings on the ideal step count and how walking can improve life expectancy for middle-aged adults.”
  • The Wall Street Journal reports,
    • “Eli Lilly’s diabetes pill, orforglipron, showed better blood sugar control than Novo Nordisk’s oral semaglutide in a Phase 3 trial.
    • “Orforglipron met primary and secondary goals across doses, with some participants reaching near-normal blood sugar levels.
    • “Lilly said the results, combined with the pill’s scalability, show its potential as a key Type 2 diabetes treatment.”
  • Per BioPharma Dive,
    • “Roivant and subsidiary company Priovant said Wednesday their inflammatory disease pill succeeded in a Phase 3 trial in the rare condition dermatomyositis, significantly reducing signs and symptoms of the disorder by more than placebo when used for one year.”
    • “Company executives said they plan to ask the Food and Drug Administration to approve the pill, called brepocitinib, in early 2026, based on trial results they called “the first ever positive registrational trial for a targeted therapy” in dermatomyositis.
    • “Brepocitinib is being developed by Priovant Therapeutics, which is part owned by Pfizer. The big drugmaker licensed the pill to Roivant in 2022 as part of a pipeline cull.”
  • and
    • AstraZeneca reported divergent outcomes from two late-stage studies on Wednesday. In one Phase 3 trial, a subcutaneous form of its marketed medicine Sophnelo helped lower signs of disease activity in people with the most common form of lupus. In the other, its drug Fasenra, used to treat asthma and a few other conditions, failed meaningfully lower the rate of moderate or severe chronic obstructive pulmonary disease attacks. The under-the-skin injection of Sophnelo is being reviewed by regulators. AstraZeneca will analyze the Fasenra data to “further understand the results,” the company said.
  • Per Fierce Pharma,
    • “SK Biopharmaceutical’s Xcopri (cenobamate) met the bar in a phase 3 trial that could support the company’s ambitions of building a blockbuster with an expansion into another seizures subtype.
    • “The South Korean pharma won FDA approval for Xcopri in 2019 as a treatment for partial-onset seizures, also known as focal seizures, in adults. Since then, with rapid global growth, SK has outlined blockbuster ambitions for the drug by 2029. 
    • “Now, with a positive phase 3 trial, another indication for primary generalized tonic-clonic (PGTC) seizures could be on the table.”
  • Beckers Hospital Review identifies “four new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports
    • “Baltimore-based Johns Hopkins Medicine has ended contract negotiations with UnitedHealthcare without a new deal, The Baltimore Banner reported Sept. 15. 
    • “Johns Hopkins went out of network with UnitedHealthcare on Aug. 25 after eight months of negotiations and several extensions of their existing agreement. 
    • “Health system leaders did not rule out an agreement in the future, but a spokesperson told The Banner they decided to make patients “aware of this stalemate now, to provide our patients and their employers the time they need to explore alternative insurance options during the upcoming open enrollment season.” 
    • “Both parties have said the impasse was not about money but other provisions in the contract, according to the report. Johns Hopkins said UnitedHealthcare was demanding overly burdensome prior authorization requirements. The payer said the system wanted to be able to exclude certain employer-sponsored plans.
    • “UnitedHealthcare Mid-Atlantic CEO Joseph Ochipinti told the news outlet the payer remains at the negotiation table. He said they expect “network providers to honor their commitment to care for the individuals and families who rely on them as in-network providers.”
  • and
    • lists the top NCQA rated commercial health plans in each state.
  • Per a Healthcare Cost Institute news release,
    • “Primary care offers patients a critical connection point to the health care system. With contact, continuity, comprehensiveness, and coordination as its base1, primary care has been shown to improve health outcomes and population health, reduce health disparities, and save health care dollars. Despite the virtues and benefits of primary care, it seems to be getting harder to access. In 2025, there were 7,901 primary care health professional shortage areas. A recent report found that primary care physicians per capita declined between 2012 and 2021, and fewer trainees chose to pursue primary care than specialty care over the same period.
    • “In response, a number of states are innovating to increase investment in primary care. By one estimate, nearly 20 states have taken action to improve primary care with initiatives ranging from defining and measuring primary care to setting specific primary care spending targets.
    • “This analysis assesses what portion of total health care spending is dedicated to primary care, in alignment with many of the primary care spending targets that are expressed as a percentage of total health care spending. We defined the percentage of primary care as the portion of ambulatory spending rendered by primary care providers (PCPs) relative to total medical and prescription spending among people with Employer-Sponsored Insurance (ESI) and Medicare Fee-for-Service (FFS) between 2018 and 2022. 
    • “The results presented below are based on a narrow definition of primary care provider based on provider specialty. We conducted the same analysis using an expanded list of specialties, (e.g., obstetrics and registered nurses and other allied practitioners). As expected, the share of primary care spending was higher using the broader definition. Otherwise, the patterns observed with the narrow definition also applied to the broader definition. The results of the analysis using both definitions are available in the downloadable data.
    • “Approximately 4% of spending went to primary care in 2022.”
  • Beckers Health IT lets us know,
    • “Epic’s revenue rose to $5.7 billion in 2024, a company spokesperson told Becker’s, as the EHR vendor continues to add health system customers.
    • “That number is up from $4.9 billion in 2023 and $1.2 billion in 2012. Epic has continued to consolidate its U.S. market share lead over the past few years, from 31% of acute care hospitals in 2021 to 42.3% in 2024, per KLAS Research. Its nearest competitor, Oracle Health, clocked in at 22.9%. Epic is the market share leader for all U.S. acute care hospital types except standalone facilities with 200 beds or fewer.”

Tuesday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • An OPM news release tells us,
    • U.S. Office of Personnel Management (OPM) Director Scott Kupor joined the Ruthless Podcast to discuss a number of wide-ranging topics including OPM’s ongoing efforts to bring top talent into the federal workforce and enhance operational efficiency across government.
    • WATCH HERE
  • The American Hospital Association News informs us,
    • “The House Appropriations Committee today released bill text for a continuing resolution to fund the government through Nov. 21. The bill also extends key health care programs set to expire Sept. 30 through the length of the CR. They include extending the Medicare-dependent Hospital and low-volume adjustment programs, telehealth and hospital at home flexibilities, delaying Medicaid Disproportionate Share Hospital cuts, and extending the Cybersecurity Information Sharing Act. The House is expected to vote on the measure this week. The Senate will follow in an attempt to avert a government shutdown by Sept. 30.”
  • Politico adds,
    • “A group of GOP senators are working on legislation to extend Affordable Care Act subsidies with policy changes designed to win over conservatives, according to four people granted anonymity to disclose private discussions.
    • “This group has gotten “technical assistance” from the Senate Finance Committee, which has jurisdiction over the subsidies, according to two of the sources. The Obamacare subsidies are set to expire at the end of this year.”
  • Per the AHA News,
    • “The House Ways and Means Oversight Subcommittee today hosted a hearing on tax-exempt hospitals. The AHA submitted a statement for the hearing, highlighting the amounts that tax-exempt hospitals spend annually on community benefits and where those funds are spent. The AHA also highlighted its analysis released Sept. 10 that found tax-exempt hospitals provided nearly $150 billion in total benefits to communities in 2022, marking a nearly 50% increase in community benefit spending from 2017. Additionally, the AHA explained why a flexible community benefit approach is best for communities as opposed to suggestions for a definition and evaluation from the Internal Revenue Service.” 
  • Per a Congressional news release,
    • Sens. Chuck Grassley (R-Iowa) and Ben Ray Luján (D-N.M.) reintroduced bipartisan legislation bolstering pharmacists’ ability to serve older Americans in communities that lack easy access to doctors or where pharmacists can provide certain basic medical services.
    • The Pharmacy and Medically Underserved Areas Enhancement Act encourages pharmacists to offer health care services (like health and wellness screenings), immunizations and diabetes management by authorizing Medicare payments for those services where pharmacists are already licensed under state law to provide them. Many states already allow pharmacists to provide these services. However, there is currently no way for pharmacists to receive Medicare reimbursement for providing them. * * *
    • “Grassley and Luján also requested feedback from stakeholders on pharmacists providing services for chronic care needs, given the unique pressing challenges of chronic care among seniors. Text of the request-for-information (RFI) can be found HERE.
    • “The full text of the legislation is available HERE.”
  • Healthcare Dive reports,
    • “Doctors — especially specialists — are pushing back against proposed changes to Medicare payment that would tamp down on reimbursement next year.
    • “Medicare’s proposed physician fee schedule for 2026 includes a base rate hike of 2.5%. But it also includes an efficiency adjustment that would reduce payment by 2.5% for thousands of procedures and changes to how regulators calculate practice expense that would lower reimbursement for services performed in facilities like hospitals.
    • “The reforms are meant to account for increased efficiency in procedures that doctors perform frequently, realign payment for primary and specialty care, and recognize larger indirect costs for doctors in office-based settings.
    • “Many physicians support those goals. But the policy changes themselves are a bad idea, doctors are warning the CMS.”
  • Fierce Healthcare points out,
    • “In its annual health plan ratings, the National Committee for Quality Assurance (NCQA) found that 11 out of 998 rated plans earning top marks, more than double last year’s total. 
    • “Of the 11 plans to achieve a 5-star rating, eight were commercial plans and three were Medicare plans. They included Blue Cross and Blue Shield of Massachusetts, UPMC Health Plan and several Kaiser Foundation Health Plans.  An additional 55 plans earned a 4.5-star rating. Most plans ranked between 3 and 4 stars, same as in 2024. The NCQA says its ratings help consumers and regulators assess the quality and effectiveness of health plans. 
    • “The report found year-over-year improvements in coordination and continuity of care in Medicare. The NCQA also identified progress across nearly all six diabetes-related measures. The Kidney Health Evaluation for Patients with Diabetes metric showed an average increase of over 5% across all product lines. 
    • “Additionally, the NCQA found improved adult and adolescent immunization rates. Though childhood immunization rates continued to decline, they did so at a slower pace than last year.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “A safety issue with certain Boston Scientific defibrillation leads has resulted in a series of new Class I recalls, according to the U.S. Food and Drug Administration (FDA). Unlike some recalls, these do not require a product to be immediately removed from the market. However, there are specific recommendations all clinicians should follow. 
    • “The FDA first shared details with the public about these concerns in early August, noting that some of Boston Scientific’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) were associated with a potential risk of rising low-voltage shock impedance (LVSI). If this occurs, it can make the leads less effective over time. 
    • “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,” the agency said at the time.”
  • The AHA News adds,
    • “The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.” 
    • “In addition, the FDA issued an early alert for certain Medline convenience kits containing Medtronic DLP Left Heart Vent Catheters due to issues found with certain lots of cannula products where the catheter may not retain its shape. Medline sent a notice to affected customers that recommended they destroy any affected product after completing the list of recall actions.” 

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy weight-loss drug helps patients stop thinking about food, according to a new study.
    • “According to results of the study, which were presented at a medical conference in Austria, patients taking Wegovy for weight-loss experienced a substantial drop in so-called “food noise”—unwanted and intrusive thoughts about food—alongside improvements in their mental well-being and lifestyle.
    • “Novo Nordisk said the number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy, while 64% of respondents reported improved mental health and 80% reported healthier habits while taking the drug.
    • “It is very encouraging to see these new data from people using Wegovy that, in addition to weight-loss, Wegovy may help quiet disruptive thoughts about food, support improved mental well-being and help enable people to live healthier lives,” said Filip Knop, incoming chief medical officer at Novo Nordisk.
    • “The U.S.-based Inform study released Tuesday surveyed 550 people taking Wegovy for weight-loss to assess the impact of the drug on mental well-being and eating habits relating to food noise.”
  • MedPage Today adds,
    • “A higher 7.2 mg dose of semaglutide led to significantly greater weight loss compared with placebo in adults with obesity, with or without type 2 diabetes.
    • “Participants across two randomized trials also had improvements in cardiovascular risk factors.
    • “Secondary and exploratory analyses suggested that the 7.2 mg dose led to a greater change in body weight versus the currently approved highest dose of 2.4 mg.”
  • Per a National Institutes of Health news release,
    • ‘The National Institutes of Health (NIH) has launched effort aimed at reducing the rate of preventable stillbirths in the United States. Investigators will develop tools, devices and other technologies that have the potential to affect diagnosis and prevention efforts relevant to stillbirth, which occurs in 1 in 160 deliveries in the U.S. About 23,600 stillbirths at 20 weeks or greater gestation are reported annually.
    • “More than 60% of stillbirth cases remain unexplained even after exclusion of common causes, such as congenital abnormalities, genetic factors, and obstetric complications. NIH will fund the Stillbirth Research Consortium for more than $37 million over five years, pending the availability of funds, with $750,000 in co-funding from the Department of Health and Human Services.
    • “This consortium will provide an integrated, collaborative program to support cutting edge research to identify the root causes of stillbirth and inform evidence-based strategies to address stillbirth risks,” said Alison Cernich, Ph.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. “Too many families needlessly face the grief of stillbirth.”
    • “People who have experienced stillbirth are almost five times as likely to experience another stillbirth or other pregnancy associated complication. The rate of stillbirth is considerably higher among Black, American Indian, and Alaska Native people. About 40% of stillbirths that occur during labor and birth are considered potentially preventable.” 
  • Genetic Engineering and Biotechnology News reports,
    • “A novel strategy developed by scientists at Rice University allows scientists to zoom in on tiny segments of proteins inside living cells, revealing localized environmental changes that could indicate the earliest stages of diseases such as Alzheimer’s, Parkinson’s, and cancer. The study results could offer promise for drug screening that targets protein aggregation diseases.
    • “The research team engineered a fluorescent probe known as AnapTh into precise subdomains of proteins, creating a tool that monitors microenvironmental shifts in real time. Unlike conventional techniques that provide only broad signals, this approach reveals how distinct regions of the same protein behave differently during the aggregation process. The work, led by Han Xiao, PhD, professor of chemistry and director of Rice’s SynthX Center, enhances the basic understanding of disease mechanisms and lays the groundwork for identifying drug targets and screening potential therapeutics at an earlier stage.
    • “We essentially built a molecular magnifying glass,” Xiao said. “This allows us to visualize subtle environmental changes that previously went unnoticed, and those early changes often hold the key to understanding protein-related diseases.” Xiao and colleagues reported on their findings in Nature Chemical Biology, in a paper titled, “Real-time imaging of protein microenvironment changes in cells with rotor-based fluorescent amino acids,” in which they concluded: “These results demonstrate that the technology reported in this paper provides a versatile tool for exploring microenvironment changes of protein substructures at high spatial resolution, enabling direct visualization of the local environment around specific amino acid residues.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY unveiled plans to build a $5 billion manufacturing facility in Virginia as part of the drugmaker’s pledge to bolster its domestic medicine production with four new pharmaceutical manufacturing sites.
    • “Eli Lilly said the new plant, located just west of Richmond in Goochland County, will be the first dedicated, fully integrated active pharmaceutical ingredient and drug product facility for its emerging bioconjugate platform and monoclonal antibody portfolio.
    • “The Indianapolis company said the site also will boost its domestic manufacturing of antibody-drug conjugates.
    • “Eli Lilly said the new plant will create more than 650 new company jobs, along with 1,800 construction jobs.
    • “Eli Lilly in February said it would invest $27 billion to build four new pharmaceutical manufacturing sites in the U.S., more than doubling its U.S. capital expansion commitments since 2020 to more than $50 billion.”
  • and
    • “So far this year, more than a dozen drugmakers [, including Lilly,] have pledged to spend more than $350 billion collectively by the end of this decade on manufacturing, research and development and other functions in the U.S., a Wall Street Journal tally of company announcements showed.
    • “The vast majority of our products going into the U.S. are manufactured in the U.S.,” GSK Chief Executive Emma Walmsley said in an interview Tuesday when the company announced its $30 billion U.S. investment in research and development and supply-chain infrastructure over the next five years. “This of course adds to it, and it’s about the new pipeline that’s going through.”
  • Modern Healthcare informs us,
    • “Health systems are revamping pediatric care to fight emergency department overcrowding before Medicaid funding cuts further endanger access. 
    • “Many emergency rooms are full, leading to care delays and provider burnout. Hospital operators have responded by tasking social workers with triage duties and setting up virtual consultations with specialists. They are also consolidating emergency services and asking data analytics companies to better track and predict capacity and utilization trends, health system executives said. 
    • “Health systems have crafted many of these strategies around pediatric patients, who may bear the brunt of the Medicaid cuts authorized by the “One Big Beautiful Bill,” among other federal policy changes, experts said.
    • “The population that will get hit the hardest in emergency medicine will be pediatrics,” said Dr. Ken Heinrich, chief medical officer of emergency medicine at staffing company SCP Health. 
    • “Providers are facing a surge in pediatric mental health issues, fueling care backlogs across hospital emergency departments. Providers have enlisted social workers and adjusted their emergency department layouts to meet that demand.”
  • and
    • “Labcorp has completed its acquisition of BioReference Health’s oncology diagnostic testing assets for up to $225 million. 
    • “The independent laboratory company paid $192.5 million at closing and and could pay up to $32.5 million more in an earn-out tied to the assets’ performance, according to a Monday news release.
    • “Labcorp previously acquired select clinical, reproductive and women’s health diagnostic assets from BioReference last September for more than $237 million.”
  • MedCity News notes,
    • “Berry Street, a nutrition therapy company, has launched its GLP-1 Nutrition Pathway Program, which is meant to provide nutrition support for those starting, taking and getting off of GLP-1s.
    • “The New York City-based company works with health plans and connects patients in need of nutrition support to a network of registered dietitians. It provides personalized treatment plans for patients struggling with weight management, diabetes, heart health, kidney disease and numerous other conditions.”
  • Per a UHC press release,
    • “Building on our March announcement committing to modernize pharmacy payment models, Optum Rx has increased reimbursement minimums for brand drugs for approximately 2,300 independent pharmacies – those not affiliated with a pharmacy services administrative organization (PSAO), chain or other entity – across the country. This move, which went into effect on September 1, 2025, will support the long-term sustainability of pharmacies, which play a critical role in patient care. 
    • “This is the latest announcement from Optum Rx, which continues to expand on initiatives to transform how pharmacies are reimbursed for drugs. Optum Rx first launched improved reimbursement earlier this year, with Epic Pharmacy Network, a PSAO representing more than 1,000 independent pharmacies, being the first PSAO to partner with us.”
  • BioPharma Dive lets us know,
    • “Novartis is broadening its bet on drugs that can destroy disease-causing proteins, agreeing Monday to a new deal with biotechnology company Monte Rosa Therapeutics.
    • “Through the collaboration, the companies will work to develop multiple novel protein “degrading” drugs for immune conditions. Monte Rosa will conduct discovery and early testing before Novartis takes over development for programs it chooses to license. The biotech will get $120 million in upfront cash per deal terms. It could also receive as much as $5.7 billion overall should various development and sales milestones be met, plus royalties on sales of any eventual products.”
    • Monte Rosa is among the many companies pursuing “molecular glue” drugs, which force together a target protein with an enzyme that flags it for destruction by the cell’s waste disposal system. The approach is seen as a way to access tough-to-reach drug targets, and is one of several strategies biotechs are using to degrade harmful proteins, rather than bind and block them as traditional drugs do.
  • Per Beckers Hospital Review,
    • “Amazon has added Fay, a dietitian platform, as the first nutrition care service available through its Health Benefits Connector.
    • “The collaboration allows eligible Amazon customers to discover and enroll in Fay’s insurance-covered nutrition services while browsing for wellness and health benefits, according to a Sept. 16 news release.
    • “Fay connects individuals with registered dietitians based on their goals, health history and insurance eligibility. Services include counseling, preventive care and coaching, which the company said are often available at no cost to patients.”

From the artificial intelligence front,

  • Fierce Healthcare reports,
    • “Healthcare accreditation body URAC is rolling out the nation’s first accreditation program for users and developers of healthcare artificial intelligence. 
    • “The first-in-the-nation program will evaluate risk management, business management and performance monitoring with specific modules for users and developers. URAC accredits organizations ranging from small pharmacies to multistate payer organizations. 
    • The organization, which has been accrediting healthcare organizations for decades, hopes the URAC gold star will help promote trust in AI.
    • “We think that this is a great opportunity to give people that seal of approval, that gold star, that someone independent has gone in behind the scenes and audited to make sure that this is trustworthy,” Shawn Griffin, M.D., CEO and president of URAC, said in an interview.”
  • and
    • “Aegis Ventures’ digital consortium gained three new members as health systems look to collaborate to develop and scale artificial-intelligence-powered health tech solutions and tackle common pain points.
    • “Yale New Haven Health System, Keck Medicine of USC and Hartford HealthCare joined the collaborative, expanding its reach to 14 regional health systems. The consortium, which includes Northwell Health, UPMC, Stanford Health Care and Vanderbilt Health, will codevelop, invest in and deploy health tech solutions alongside Aegis Ventures. 
    • “The partnerships with the three new health systems will accelerate the consortium’s pipeline of companies with two startups set to launch this fall, according to John Beadle, co-founder and managing partner of Aegis Ventures.
    • “Next year, I think we could be more aggressive, just given that the model of the blueprint worked well. We have the right set of partners, the right team, the resources are in place to do it, but I think we’re most focused on seeing this year out really strong,” Beadle said.”
  • and
    • “Healthcare technology and AI company Innovaccer has acquired Story Health, a digital specialty care platform with health system inroads.
    • “Financial terms of the deal, announced Tuesday, were not disclosed. Innovaccer said the deal adds to its scalable Healthcare Intelligence Cloud offering, which in recent months was bolstered by the company’s other strategic acquisitions.
    • “Healthcare doesn’t change through dashboards alone,” Abhinav Shashank, co-founder and CEO of Innovaccer, said in the announcement. “It changes when data and AI power completely new clinical models. Story Health has proven that in specialty care; and we’re excited to bring this technology and clinical expertise to our health system customers nationwide.”
    • “Cupertino, California-based Story Health, a Fierce 15 2024 honoree, launched in late 2020 and has raised about $27 million in funding from backers such as Northpond Ventures, B Capital Group, LRVHealth, Define Ventures and General Catalyst. Its approach combines virtual coaching, biometric monitoring and care team alerts to support patients with chronic conditions between clinical visits.”

Midweek report

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

From Washington, DC,

  • Beckers Health IT informs us,
    • “Federal lawmakers have introduced a bill to extend Medicare telehealth flexibilities and CMS’ hospital-at-home waiver.
    • “The Telehealth Modernization Act of 2025 would prolong the telehealth program through Sept. 30, 2027, and CMS’ reimbursement of acute hospital care at home through 2030. The measures otherwise expire Sept. 30.
    • “Telehealth is a vital part of our healthcare system, and we must ensure that it is available to patients who need it,” said U.S. Rep. Earl “Buddy” Carter, R-Ga., in a Sept. 2 news release. “By extending telehealth flexibilities for patients, we are making healthcare more accessible, regardless of their physical location.”
    • “Mr. Carter introduced the House bill with Rep. Debbie Dingell, D-Mich., while a companion Senate bill is being led by Sens. Tim Scott, R-S.C., and Brian Schatz, D-Hawaii. Nearly 50 health systems have called for the telehealth extension.”
  • Federal News Network reports,
    • “The Office of Personnel Management is taking a closer look at the details for implementing President Donald Trump’s proposal for a larger pay raise for federal law enforcement personnel next year.
    • “The announcement from OPM comes a couple days after Trump called for a 3.8% pay raise in 2026 for federal employees working in law enforcement jobs.
    • “Certain frontline law enforcement personnel are critical to implementing the President’s strategy to secure the border, protect our country and keep American citizens safe,” OPM said this week in new guidance. “Without special salary rates, the government may find it difficult to recruit and/or retain the number of these personnel needed to properly enforce our borders, uphold our immigration laws and protect law-abiding citizens.”
    • “It’s not yet clear which specific positions or how many law enforcement officials will be included in the new special salary rate. OPM said it plans to consult with the departments of Homeland Security, Justice and Interior to define which jobs will be eligible for the larger law enforcement pay raise next year.
    • “Generally, though, OPM said the upcoming special salary rate will cover agents in the Border Patrol and the Drug Enforcement Administration, criminal investigators at Immigration and Customs Enforcement (ICE), Secret Service personnel, officers at the Federal Protective Service and the FBI, and correctional officers at the Federal Bureau of Prisons — among several other groups.”
  • and
    • “After unveiling a series of immediate acquisition changes over the summer, the Trump administration is on track to debut a formal rulemaking to overhaul and streamline the Federal Acquisition Regulation, or the FAR, this fall.
    • “Larry Allen, the associate administrator for General Services Administration’s Office of Government-wide Policy, discussed the ongoing FAR revisions and the forthcoming rulemaking during AFCEA Bethesda’s “Health IT” conference in Washington on Wednesday.
    • “Under an April executive order, the White House Office of Federal Procurement Policy and the FAR Council are leading an effort to “return the FAR to its statutory roots, rewritten in plain language, and remove most non-statutory rules.”
    • “In recent months, the FAR Council has issued a series of “class deviations” for multiple parts of the FAR. Recent deviations have focused on prioritizing the use of governmentwide contracts and simplifying commercial acquisition.” * * *
    • “In follow-up guidance to the executive order, the Office of Management and Budget said the FAR Council will turn to formal rulemaking after it has posted model deviations for all FAR parts.”
  • It’s worth adding that reginfo.gov no longer carries an “under repair” warning and while the regulatory review pages are up to date, the regulatory agenda page still features the Fall 2024 edition.
  • Govexec considers whether FEGLI Option B is really the best life insurance choice? FEGLI plans remain a solid life insurance option for federal employees, but, depending on the coverage, it may also be wise to look to the private market.
  • Following up on yesterday’s FEHBlog, Beckers Hospital Review notes,
    • “A federal rule enabling real-time access to prescription drug pricing, coverage details and prior authorization requirements is set to take effect Oct. 1. 
    • “The regulation, finalized in July as part of the CMS Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System final rule, will require healthcare providers to use certified health IT systems to electronically submit prior authorization requests, check real-time prescription drug pricing during patient encounters and share electronic prescription data with pharmacies and insurers.”
  • Fierce Healthcare adds,
    • “The Department of Health and Human Services’ investigation unit and health IT offices are stepping up enforcement of information blocking committed by providers, health IT developers and health information exchanges, the department announced Wednesday. 
    • “The news comes as Trump’s HHS is trying to improve the flow of patient health information by securing voluntary commitments by 60 major healthcare and tech companies to advance interoperability. 
    • “A press release by HHS says Health Secretary Robert F. Kennedy Jr. has “directed increased resources” to investigate and enforce information blocking rules.
    • “The Office of the Assistant Secretary for Technology Policy (ASTP/ONC) has already begun to review reports of information blocking and provide technical assistance to HHS’ Office of the Inspector General to assist their investigations, Assistant Secretary Thomas Keane said in a statement.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect. Through the RDEP process, sponsors will receive clearer guidance on the types of evidence that can be used to demonstrate substantial evidence of effectiveness.
    • “Drug developers – and the patients they hope to treat – deserve clear, consistent information from the FDA,” said FDA Commissioner Marty Makary, M.D., M.P.H.  “These principles ensure that FDA and sponsors are aligned on a flexible, common-sense approach within our existing authorities, and that we incorporate confirmatory evidence to give sponsors a clear, rigorous path to bring safe and effective treatments to those who need them most.”    
  • BioPharma Dive reports,
    • “Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also the company’s first commercial product since it sold off its main revenue driver a few years ago.
    • “After some delays, the Food and Drug Administration is set to issue an approval verdict on this medicine sometime between October and the end of December. If cleared for market, the oral drug would be sold as Vyglxia and used to treat patients with spinocerebellar ataxia, a type of genetic disorder where the progressive erosion of nerve cells causes problems with movement, coordination and brain function.”
  • Per MedTech Dive,
    • “Medtronic has received an expanded label from the Food and Drug Administration to pair its MiniMed 780G insulin pump with a glucose sensor being developed by Abbott for Medtronic.
    • “Medtronic and Abbott will submit required compliance documentation for sensor integration and marketing in the coming weeks, finishing the regulatory process, the companies announced Tuesday.
    • “The FDA decision also expands the insulin pump to adults with Type 2 diabetes.”

From the public health and medical/Rx research front,

  • The American Hospital News tells us,
    • “The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory syncytial virus this upcoming respiratory virus season compared to last year’s, according to its 2025-26 outlook released Aug. 25. The agency is predicting higher peak weekly COVID-19 hospitalization rates this season, particularly if a variant with moderate immune-escape properties emerges.”
  • and
    • “The AHA Sept. 3 released a study conducted by KNG Health Consulting that found Medicare patients who receive care in a hospital outpatient department are more likely to come from geographically isolated and medically underserved communities and be sicker and more complex to treat than Medicare patients treated in independent physician offices. Specifically, the study found that Medicare patients who are seen in HOPDs — including those with cancer — are more likely to be from rural and lower-income areas, living with more severe chronic conditions, dually-eligible for both Medicare and Medicaid, previously hospitalized or cared for in a hospital emergency department, and under 65 and eligible for Medicare based on disability.”
  • The Wall Street Journal discusses how to get the new Covid vaccine.
  • NBC News adds,
    • “An over-the-counter nasal spray which has been used for years as a safe and effective treatment for seasonal allergies could potentially prevent Covid infections, according to clinical trial results released Tuesday.
    • “The antihistamine azelastine works as an antiviral against a range of respiratory infections, including influenza, RSV and the virus that causes Covid, a growing number of studies have shown.” * * *
    • “Our findings suggest azelastine could serve as a scalable, over-the-counter prophylactic against Covid, especially when community transmission is elevated or in high-risk settings such as crowded indoor events or travelling,” said Dr. Robert Bals, professor of internal medicine and pneumology at Saarland University and the study’s senior author.
    • “The trial had limitations, namely that the participants were all young and relatively healthy, he said. 
    • “Bals said that azelastine should not be seen as a replacement for vaccinations, and larger studies were needed before recommending it as a routine preventative measure for the general public, and especially vulnerable groups.”
  • Per a National Institutes of Health news release,
    • “Researchers funded by the National Institutes of Health (NIH) have found that a single injection of the antibiotic benzathine penicillin G (BPG) successfully treated early syphilis just as well as the three-injection regimen used by many clinicians in the United States and elsewhere. These findings from a late-stage clinical trial suggest the second and third doses of conventional BPG therapy do not provide a health benefit. The results were published today in The New England Journal of Medicine.
    • “Benzathine penicillin G is highly effective against syphilis, but the three-dose regimen can be burdensome and deter people from attending follow-up visits with their healthcare providers,” said Carolyn Deal, Ph.D., chief of the enteric and sexually transmitted infections branch of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “The new findings offer welcome evidence for potentially simplifying treatment with an equally effective one-dose regimen, particularly while syphilis rates remain alarmingly high.”
    • “Syphilis is a common sexually transmitted infection (STI) caused by the bacterium Treponema pallidum. The United States reported 209,253 total syphilis cases and 3,882 congenital syphilis cases in 2023, representing 61% and 108% increases over 2019 numbers, respectively. Without treatment, syphilis can result in neurological and organ damage as well as severe pregnancy complications and congenital abnormalities. Syphilis can also increase a person’s likelihood of acquiring or transmitting HIV.
    • “BPG is one of the few antibiotics known to effectively treat syphilis, and stockouts are common worldwide. The antibiotic is currently being imported to the United States to resolve a nationwide shortage.”
  • Per Beckers Hospital Review,
    • “Researchers have successfully used repurposed cancer drugs to target dormant breast cancer cells, aiding in the delay or prevention of recurrence, according to a study published Sept. 2 in Nature Medicine. 
    • “Researchers from Philadelphia-based University of Pennsylvania’s Abramson Cancer Center and Perelman School of Medicine enrolled 51 breast cancer survivors to identify and target the cells with existing cancer drugs.” * * *
    • “Read the full study here.” 
  • Per Healio,
    • “Nonsurgical treatments may offer long-term reductions in pain and disability for patients with chronic low back pain.
    • “Treatment options included cognitive behavioral therapy, mindfulness and exercise.”
  • Per Health Day,
    • “Guidelines recommend that preschoolers diagnosed with ADHD first get six months of behavioral therapy before drug therapy is initiated
    • “New research shows this rule is followed by U.S. doctors only about 14% of the time, and that could mean poorer outcomes for kids
    • “A lack of access to therapists is often cited as a reason for starting meds soon, but experts say there are ways around that.”

From the U.S. healthcare business front,

  • Fierce Pharma points out,
    • “After joining multiple other drugmakers on the U.S. investment bandwagon earlier this year, Gilead Sciences is providing further details on where it plans to channel its $32 billion pledge.
    • “Gilead has broken ground on a new pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, the company said Tuesday.
    • “The new facility, which will reach five stories and cover 180,000 square feet, will serve the company’s technical development and manufacturing teams, leveraging a mix of digitalization, autonomous robotics and real-time digital monitoring. Additionally, the project is expected to boost Gilead’s capabilities and capacity around biologics, which the company described as a “central pillar” of its broader growth strategy.”
  • Beckers Hospital Review lets us know,
    • “Cincinnati-based TriHealth has completed the acquisition of Clinton Memorial Hospital, a 140-bed facility in Wilmington, Ohio, marking its sixth acute care hospital.
    • “The facility will be renamed TriHealth Clinton Regional Hospital and serve as a hub for the system’s specialized services, including women’s health, cancer, heart and vascular, neurosciences and stroke care.
    • “This new name will extend TriHealth’s brand promise to ‘see, to hear and to heal … delivering surprisingly human care’ to the residents of Clinton County,” TriHealth President and CEO Mark Clement said in a Sept. 2 news release. “And it will also affirm TriHealth’s commitment to invest in the hospital and expand services locally, establishing it as a regional hub for TriHealth’s exceptional, nationally recognized care.”
  • Fierce Healthcare reports,
    • “HonorHealth, an Arizona-based health system, is acquiring a number of Evernorth Care Group locations across Phoenix.
    • “Evernorth Care Group lists 18 centers offering integrated primary care services to nearly 80,000 patients throughout the metropolitan area. The clinics will become part of HonorHealth at the close of the deal, slated for January 2026, pending regulatory approvals.
    • “This acquisition enhances the services we offer and expands Valley residents’ access to care,” HonorHealth CEO Todd LaPorte said in the announcement. The financial terms were not disclosed.” 
  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s prior authorization gold card program has seen a more than 40% increase in the number of qualifying provider groups in 2025, the company shared with Becker’s.
    • “Launched in October 2024, the program reduces prior authorization requirements in favor of advance notification for provider groups that consistently adhere to evidence-based care guidelines.
    • “Providers can lose gold-card status because of patient safety issues, failure to cooperate with quality and patient safety activities, failure to make timely responses to requests for information, or because they no longer meet program requirements. UnitedHealthcare conducts annual evaluations for gold card qualification, with determinations effective on Oct. 1 every year. 
    • “On Sept. 1, provider groups could begin viewing their program status in the UnitedHealthcare Provider Portal. Starting Oct. 1, additional groups will be eligible.”
  • and
    • “Economic uncertainty and policy changes from the current administration have changed the way health plans operate over the past year. Many have found workarounds to continue efficiency and growth.
    • “Becker’s connected with five leaders to learn their biggest accomplishments so far in 2025.”
    • Check it out.
  • Milliman has posted its “2025 Milliman Retiree Health Cost Index.”
  • McKinsey & Co. discusses “the quantum revolution in pharma: Faster, smarter, and more precise.”
    • “Quantum computing presents a multibillion-dollar opportunity to revolutionize drug discovery, development, and delivery by enabling accurate molecular simulations and optimizing complex processes.”
  • Radiology Business notes,
    • “Hospital- and private equity-affiliated radiology practices command significantly higher prices than their independent practice counterparts, according to new research published Tuesday. 
    • “Consolidation of imaging groups has accelerated in recent years, with limited evidence on how this change impacts economics within the specialty. Researchers with Brown University recently set out to understand how such M&A activity has changed prices for radiology services, sharing their findings in the Journal of the American College of Radiology (JACR). 
    • “They found a noteworthy gap, with negotiated professional prices for hospital-based radiology services about 43% higher than independents. That’s compared to about 16% higher for investor-backed radiologists versus others in private practice. 
    • “Our findings demonstrate significant differences in negotiated radiologic service prices by practice ownership, with hospital and PE-affiliated practices able to negotiate higher professional fees than independent practices,” corresponding author Yashaswini Singh, PhD, MPA, a healthcare economist and professor with the Providence, Rhode Island, institution, and colleagues concluded. “These results highlight the financial implications of ongoing consolidation in radiology and underscore the need for continued research into how these trends affect radiologists, insurers and patients.”

Friday report

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

From Washington, DC,

  • Here is a link to the OPM Director’s weekly blog post.
    • “Of course, government doesn’t – and shouldn’t – function like private entrepreneurship. We can’t shoot for the moon and embrace unbridled risk as do venture-backed startups. But government can embrace a growth mindset – not leaving good enough alone, but instead always thinking about ways in which we can improve operational efficiency, try new things, and embrace change.”
  • Govexec reports,
    • “President Trump has just nine days to issue his likely plan to freeze federal employees’ salaries in 2026, before sizeable automatic and across-the-board increases take hold.
    • “Each August, the president must issue an alternative pay plan, declaring an economic emergency to avert the automatic implementation of sizeable increases to locality pay due to the 1990 Federal Employees Pay Comparability Act. Administrations of both parties have bemoaned the way that the law calculates those automatic adjustments, hence the annual sidestep of that provision.”
  • and
    • “The Internal Revenue Service is no longer planning to pursue layoffs as it seeks to rebuild parts of its workforce. The tax agency is now working to plug staffing holes with hiring, reassignments and rescinding the administration’s deferred resignation offer for some employees upon finding mission-critical staffing gaps. 
    • “The decision to forgo layoffs, confirmed by two sources briefed on the matter, marks a significant reversal for an agency that has shed about a quarter of its staff and had earlier this year planned to issue widespread reductions in force.”
  • Per a National Institutes of Health news release,
    • “I [NIH Director Jay Bhattacharya, MD] am pleased to announce the release of NIH’s new plan to promote gold standard science across all agency activities. Building on NIH’s longstanding commitment to scientific integrity, this forward-looking plan incorporates the nine, interlocking tenets of gold standard science adopted by the U.S. Government and aligns with the Department of Health and Human Services’ framework for achieving these principles.”
  • STAT News lets us know,
    • “The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting System, was updated quarterly. 
    • “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public,” FDA Commissioner Marty Makary said in a statement. “We’re closing that waiting period and will continue to streamline the process from start to finish.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal court in Maryland has blocked [Dropbox link to opinion] several parts of a health insurance exchange enrollment and eligibility rule days before they were set to take effect.
    • “The U.S. District Court for the District of Maryland temporarily stayed seven provisions from a Centers for Medicare and Medicaid Services rule issued June 20 and set to go live Monday.
    • “Judge Brendan Herson’s Friday ruling temporarily blocks a $5 premium penalty on auto-reenrollments, along with a policy disqualifying people for advance payment of subsidies if they didn’t file income taxes and failed to reconcile their tax credits in a previous year. 
    • “It also stops regulators from eliminating guaranteed insurance coverage for individuals with past-due premiums and pauses a requirement that exchanges verify certain household income data.
    • “Also on pause are policies to require pre-enrollment eligibility checks ahead of a special enrollment period and a change to the formula used to calculate plan tiers. 
    • “The ruling allows CMS’ methodology for calculating premium adjustments, along with its elimination of a 60-day window for enrollees to resolve household income data, to go forward. 
    • “The court did not weigh in on other provisions in the regulation, such as the shorter open enrollment period. Plaintiffs are not contesting the changes to the low-income enrollee signup period.”

From the public health and medical research front,

  • The Centers for Disease Prevention and Prevention announced today.
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is going up across the country. Emergency department visits for COVID-19 are increasing among all ages and highest in young children. COVID-19 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.
    • “Vaccination
      • “Research finding: An MMWR report released August 21, 2025, found that in the first RSV season (2023–24) where RSV prevention products were available, 29% of infants born during October 2023–March 2024 were immunized against RSV through receipt of nirsevimab (a monoclonal antibody) or maternal RSV vaccination during pregnancy. The report used data from immunization information systems representing 33 states and the District of Columbia. State-specific immunization coverage ranged from 11% to 53%. Preliminary data from the 2024–25 season suggested that RSV immunization coverage increased nationally.
      • “The recent FDA approval and CDC recommendation for an additional monoclonal antibody, clesrovimab, could further increase access and immunization coverage for infants in the 2025–26 respiratory virus season. RSV immunization products will be available beginning in September for most of the continental United States.”
  • The University of Minnesota’s CIDRAP adds,
    • “Emergency department (ED) visits for COVID, still at low levels, also rose, up 15.2% compared to the previous week. Levels are higher in the South, Southeast, and West compared with other parts of the country. The CDC said ED visits are rising for all age groups and are highest in young children.
    • “Hospitalization rates have shown a slight upward trend since July, and the rate of deaths from COVID remains low with no change reported compared with the previous week. 
    • “Due to technical issues, the CDC did not report wastewater data for COVID, influenza A, or respiratory syncytial virus (RSV) today and said it would resume updates as soon as possible. Last week, it said the overall detection level was low and highest in the West.”
  • and
    • “The Kansas Department of Health and Environment (KDHE) yesterday announced the end of a large measles outbreak in the southwestern part of the state, after two incubation periods passed with no new cases.” * * *
    • “Elsewhere, the Wisconsin Department of Health Services and Oconto County Public Health have identified five more measles infections linked to nine earlier cases reported from Oconto County in early August, bringing the total to 14. 
    • “Officials said the ongoing investigation indicates that measles is spreading locally. Oconto County is located in northeastern Wisconsin and is part of the Green Bay area.
    • “In other measles developments, the Pennsylvania Department of Health yesterday issued an alert about potential measles exposures in four counties after an out-of-state traveler visited the state while contagious. The exposures occurred in Adams, Clearfield, Lancaster, and York counties. Locations included two Mennonite facilities, along with a travel center, a restaurant, and an entertainment venue.”
  • Genetic Engineering and Biotechnology tells us,
    • In neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Parkinson’s, and Alzheimer’s, healthy brain cells are damaged by aberrant reactive oxygen species (ROS). A potential treatment involves neutralizing ROS using antioxidant drugs. But these approaches failed to penetrate the brain effectively or proved unstable or indiscriminately damaged healthy cells. 
    • Now, a new study led by scientists at the Institute for Basic Science (IBS) in Daejeon, South Korea explores how the brain defends itself against hydrogen peroxide, a particularly harmful ROS. Using advanced imaging and molecular analysis, they discovered that hemoglobin exists in the nucleolus of astrocytes, where it acts as a “pseudoperoxidase” that breaks down H₂O₂ into harmless water. Full details are published in a new Signal Transduction and Targeted Therapy paper titled “Hemoglobin as a pseudoperoxidase and drug target for oxidative stress-related diseases.”
    • “The key was to uncover hemoglobin’s antioxidant potential in the brain and design a ‘first-in-class’ compound that could selectively enhance it,” said Won Woojin, PhD, first author on the study. “By boosting a natural defense mechanism rather than introducing an external antioxidant, we achieved strong and lasting protection across multiple disease models associated with oxidative stress.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Pittsburgh-based insurer Highmark brought in $16.5 billion in revenue for the first half of 2025, leaning on its health system and other diversified businesses as headwinds batter its payer unit.
    • “That includes $121 million in operating income and $329 million in net income for the first six months of the year. As of June 30, the company had $10.3 billion in net assets.
    • “The midyear financial results reflect an ongoing rebound at Allegheny Health Network, Highmark’s health system. The AHN posted $2.8 billion in revenue and $72 million in operating income for the first half of the year, bolstered by significant improvements to volumes across multiple categories.
    • “In the first half of the year, inpatient discharges and observations were up by 4% and outpatient registrations were up by 5% compared to the first six months of 2024. The AHN also saw a 7% increase in physician visits and a 4% increase in emergency room visits year over year.”
  • Beckers Hospital Review points out,
    • “Boston-based New England Baptist Hospital has the lowest hospital wide readmission rate, while Oroville (Calif.) Hospital has the highest, according to CMS’ Unplanned Hospital Visits database.
    • “The data, released Aug. 6, is based on provider data for hospital return days, including unplanned readmission measures and measures of unplanned hospital visits after outpatient procedures. The data was collected between July 1, 2023, and June 30, 2024.
    • “The article identifies] the 10 hospitals with the highest and lowest hospital wide readmission rates, along with their respective scores.
  • Medical Economics relates,
    • “For decades, referrals and word-of-mouth were the main routes to finding a new physician. Now, according to rater8’s 2025 report, “The Next Evolution of Patient Choice: The Rise of AI in Healthcare Search,” patients are increasingly relying on artificial intelligence (AI), online reviews and social media when deciding where they should seek care.
    • “The survey of more than 1,000 U.S. adults found that 70% are open to — or are already using — AI tools to research physicians. Among patients, 26% said AI recommendations directly influenced their decision — nearly equal to primary care referrals (28%) and health care review sites (29%).”
  • MedTech Dive calls attention to the fact that the “robotic surgery market battle is heating up. After a busy summer of surgical robotics news, check out MedTech Dive’s roundup of coverage in the space.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NCQA, NIH, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The OPM Inspector General recently issued a data brief titled Evaluation of FEHBP Medical Conditions by Premium Expenditure during Contract Years 2019 through 2021. The most expense conditions, representing 10% of spending, was cancer.
  • STAT News reports,
    • “The Centers for Disease Control and Prevention is increasing security after the shooting at its Atlanta headquarters earlier this month, leaders told employees in an email reviewed by STAT.
    • “Additional guards have been added to nearly all campuses, according to the email. CDC is in talks with the Federal Protective Services to increase security at two the campuses where it provides security as well, per the email.”
  • and
    • “Sens. Roger Marshall (R-Kansas) and John Hickenlooper (D-Colo.) are leading a new push to strengthen requirements on price transparency in hospitals, Marshall writes in a new STAT First Opinion article.
    • “The two senators introduced a new bill, the Patients Deserve Price Tags Act, which would require machine-readable files for all negotiated and cash prices, require hospitals to post prices for services, and require patients to receive an explanation of benefits as well as an itemized bill.
    • “It’s part of a years-long movement to crack down on billing practices among providers — one the White House joined in earlier this year via executive order.
    • “But the bipartisan push is far from a guarantee of changes in the current law. Even some widely backed health proposals in Congress have been left behind in must-pass packages. Read Marshall’s piece.”
  • Per a CMS news release,
    • “The U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) are establishing the Healthcare Advisory Committee—a group of experts charged with delivering strategic recommendations directly to HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz to improve how care is financed and delivered across Medicare, Medicaid and the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.
    • “Every American high-quality, affordable care – without red tape, corporate greed, or excessive costs,” said HHS Secretary Robert F. Kennedy Jr. “This new advisory committee will unite the best minds in healthcare to help us deliver real results, hold the system accountable, and drive forward our mission to Make America Healthy Again.” * * *
    • “For more information or to submit nominations, visit the Federal Register Notice at: https://www.federalregister.gov/d/2025-16136.” 
  • Healthcare Dive observes,
    • “White House data sharing plan boasts big ambitions, but has scant details.
    • “Improving health data exchange is a worthy goal, but the initiative has to overcome challenges like data security, under-resourced providers and slow technology uptake, experts say.”
  • Per BioPharma Dive,
    • “The United States and the European Union formalized the terms of the framework trade agreement the two trading partners announced at the end of July, per a joint statement published by the White House Thursday.
    • “The statement provides additional clarity and detail surrounding the terms U.S. President Donald Trump and European Commission President Ursula von der Leyen shared following negotiations in Scotland on July 27, including a 15% tariff on EU imports by the U.S. The two trading partners will “promptly document” the agreement, per the statement.
    • “Under the agreement, the U.S. committed to apply either a tariff of 15% or a “most-favored nation” duty rate on EU imports, with the higher of the two to be enforced. The U.S. will set a cap of 15% on tariffs for imports of pharmaceuticals, semiconductors and lumber, per the statement. Those sectors are currently under Section 232 investigation. Similar probes have led to sector-specific tariffs of up to 50%.
    • “The U.S. also plans to apply only the most-favored nation rate set by the World Trade Organization to aircraft and aircraft parts, generic pharmaceuticals, chemical precursors and “unavailable natural resources,” effective Sept. 1. The two trading partners will “consider other sectors” to add to that group.”
  • The Government Accountability Office tells us,
    • “Over the last decade, federal revenues from tobacco excise taxes have dropped by more than 30%—from about $14 billion to $9 billion from fiscal years 2014 to 2024.   
    • “This loss in revenues is the result of 1) declines in sales for smoking products and 2) differing tax rates for these products. It also coincides with the emergence of new products that aren’t taxed at all.” * * *
    • “If similar tobacco products were taxed the same rate (keeping in mind that some aren’t taxed at all), federal revenues would increase. We estimated that if the tax rate for pipe tobacco were increased to the same rate as roll-your-own tobacco, the federal government could collect at least $1.5 billion dollars in additional revenue for both products from fiscal years 2025-2029.  
    • “Federal revenue would also likely increase if the minimum tax rate for large cigars was the same as that for small cigars. However, it’s a bit trickier to determine a precise estimate because of limited information about the retail prices of large cigars and how consumers might respond to increased taxes.  
    • “We previously recommended that Congress consider leveling (or equalizing) the tax rate on similar tobacco products.  For a more in-depth look at tobacco taxes, check out our new report.” 
  • Tammy Flanagan, writing in Govexec, points out that “Federal employees older than 70 may be leaving thousands on the table. Find out if you or your spouse is missing Social Security benefits.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds.
    • “Plant, once owned by Catalent and now owned by Novo Nordisk, is widely used by pharma industry.
  • and
    • “The Food and Drug Administration has agreed to decide by late next month whether to approve an ultra-rare disease drug developed by Stealth BioTherapeutics, a significant step after the company claimed it may have to close its doors if an agency endorsement is not made in coming weeks.
    • “The move comes after protracted uncertainty surrounding the fate of the medication, which was developed to treat Barth syndrome, a rare illness that afflicts about 150 people in the U.S. The company and the FDA have struggled to agree on ways to generate enough of the right kind of study data to make the drug available to this tiny population of patients.”
  • PharmaPhorum lets us know,
    • “Iterum Therapeutics has become the first drugmaker to bring an oral antibiotic in the penem class to market in the US, launching Orlynvah as a treatment for uncomplicated urinary tract infections (uUTIs).
    • The launch of the product – which comes a few months after Orlynvah (sulopenem etzadroxil and probenecid) was approved by the FDA – keeps the Dublin, Ireland-headquartered biotech ahead of rival companies bidding to bring new therapies for uUTIs to the US market.
    • That includes GSK with Blujepa (gepotidacin) – which was approved in March by the FDA as the first drug with a new mechanism of action for uUTIs in nearly three decades – as well as Alembic Pharma with Pivya (pivmecillinam), cleared for uUTIs in 2024 and acquired when Alembic bought Utility Therapeutics last month. Both Blujepa and Pivya are due to be launched in the US before the end of the year.
    • Specifically, Orlynvah was given a green light by the FDA for adult women with uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis with limited or no alternative oral antibacterial options. It was initially turned down by the agency, which issued a complete response letter (CRL) to Iterum in 2021 with a request for more data.
  • Per MedTech Dive,
    • “NeuroOne Medical Technologies received Food and Drug Administration clearance for a minimally invasive nerve ablation system to treat trigeminal neuralgia, a condition that causes severe, chronic facial pain.
    • “Trigeminal neuralgia is typically treated with medication or invasive procedures. NeuroOne’s OneRF ablation system uses radiofrequency energy to create lesions to interrupt pain signals.
    • “NeuroOne filed its FDA submission in April, earlier than previously anticipated. The Eden Prairie, Minnesota-based company said Monday it now expects to launch the device on a limited basis in the fourth quarter of this year.”
  • BioPharma Dive informs us,
    • “The Food and Drug Administration on Thursday approved a drug Ionis Pharmaceuticals developed for the rare genetic disease hereditary angioedema, making the therapy, known as donidalorsen, the third new medicine to reach market this year for the rare genetic condition.
    • “Donidalorsen, which Ionis will sell under the brand name Dawnzera, is approved to prevent the swelling attacks associated with hereditary angioedema in adults and children at least 12 years of age. Dawnzera has a list price of $57,642 per dose, company executives said in a conference call.
    • “The price is “based on the efficacy, the data and the supporting evidence,” Chief Global Product Strategy Officer Kyle Jenne told analysts on the call. “The payers, we believe, will be very accepting of the price, since it’s in line with the other products that are in the HAE space today.”
  • and
    • “A total of 1,176 products have received the Food and Drug Administration’s breakthrough device designation since 2015, according to the agency’s latest update on Wednesday.
    • “The FDA gives the designation to devices that may provide more effective treatment or diagnosis of life-threatening or debilitating conditions. In its 2025 fiscal year, which began in October, the agency had granted 136 breakthrough designations as of June 30.
    • “The FDA shared the update as medical device companies lobby for faster Medicare coverage of breakthrough devices.”

From the judicial front,

  • Bloomberg Law reports,
    • “A divided US Supreme Court let the Trump administration cut off potentially hundreds of millions of dollars in medical research grants that government officials say don’t align with the president’s policies.
    • “The justices largely put on hold a federal trial judge’s decision that the National Institutes of Health acted in an “arbitrary and capricious” manner when it terminated thousands of grants as part of President Donald Trump’s crackdown on diversity, equity and inclusion.”

From the public health and medical research front,

  • Per an FDA news release,
    • “FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Frozen, Raw, Half-shell Oysters from Republic of Korea Potentially Contaminated with Norovirus.”
  • Health Day informs us,
    • “Seniors with known heart-related problems aren’t doing a very good job taking steps to protect their health, a new study says.
    • “Older folks with high blood pressure, stroke survivors and heart failure patients in the United States all have been neglecting Life’s Essential 8 — a checklist of lifestyle factors that can protect heart health, researchers found.
    • “On average, participants with one cardiovascular disease had a Life’s Essential 8 score 9 points lower than those without cardiovascular disease,” lead researcher James Walker, a medical student at Northwestern University in Chicago, said in a news release.
    • “Life’s Essential 8 recommends that people eat healthy, exercise, avoid smoking, sleep better, lose excess weight, and manage their cholesterol, blood sugar and blood pressure levels, according to the American Heart Association.”
  • MedPage Today lets us know,
    • “Patients taking GLP-1 agonists for weight loss had a small but significantly lower risk of developing cancer, a large retrospective cohort study showed.
    • “With follow-up ranging from 1 to 11 years, use of GLP-1 agonists, such as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), was associated with a 17% lower cancer risk as compared with non-users. Cancer incidence was lower for 12 of 13 recognized obesity-related cancers, plus lung cancer. The difference between users and non-users reached statistical significance for endometrial and ovarian cancers and meningioma.
    • “The only outlier was kidney cancer, which occurred more often among users of GLP-1 agonists and was associated with a non-significant 38% increased risk, reported Jiang Bian, PhD, of the Regenstrief Institute in Indianapolis, and co-authors in JAMA Oncology.
    • “Given that more than 137 million individuals in the U.S. are currently eligible for GLP-1RA [receptor agonist] therapies, even modest changes in cancer risk could have substantial public health implications,” the authors stated in their discussion. “This study is one of the first to assess the association between GLP-1RA use and cancer risk in the broad, real-world population with obesity or overweight who are eligible for AOMs [anti-obesity medications].”
  • Per a National Institute of Standards and Technology news release,
    • “Scientists at the National Institute of Standards and Technology (NIST) have developed a new technology for measuring how radiation damages DNA molecules. This novel technique, which passes DNA through tiny openings called nanopores, detects radiation damage much faster and more accurately than existing methods. It could lead to improved radiation therapy for cancer and more personalized care for individuals during radiological emergencies.
    • “With nanopore sensing, we’re not just measuring radiation damage; we’re rewriting the rules on how quickly and effectively we can respond to both cancer care and emergencies,” said NIST physical scientist Joseph Robertson.”
  • Per a National Institutes of Health news release,
    • “In a first-of-its-kind study, researchers found that the brain’s control center for a lost appendage can persist long after surgical amputation, which stands in stark contrast to longstanding theories about the brain’s ability to reorganize itself, also known as plasticity. Scientists from the National Institutes of Health (NIH) and their colleagues examined human brain activity before and after arm amputation and found that the loss of a limb does not prompt a large-scale cerebral overhaul. Published in the journal Nature Neuroscience, this study offers new insight into the mysterious phantom limb syndrome and could help guide the development of neuroprosthetics and pain treatments for people with limb loss.
    • “A team of scientists from NIH and University College London acted on a unique window of opportunity, running MRI scans on three participants in the months prior to a planned amputation (performed for separate medical purposes) and then up to five years after.
    • “It’s not often you get the chance to conduct a study like this one, so we wanted to be exceedingly thorough,” said co-author Chris Baker, Ph.D., of NIH’s National Institute of Mental Health (NIMH). “We approached our data from a variety of angles and all of our results tell a consistent story.”
  • Per NCQA.
    • ‘Chronic kidney disease (CKD) affects nearly 36 million adults in the U.S., yet it remains underdiagnosed and undertreated. NCQA convened an expert panel of clinicians and patient advocates to discuss current challenges and future opportunities associated with the assessment, diagnosis and management of CKD.’
    • This NCQA article discusses this convention.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth is forming a new board committee to “monitor and oversee financial, regulatory and reputational risks” as the healthcare juggernaut tries to improve its standing with lawmakers, regulators, investors and the U.S. public.
    • “The “public responsibility committee” will “provide an additional layer of governance,” UnitedHealth said in a securities filing on Wednesday. The committee’s key responsibilities include underwriting and forecasting, regulatory relationships, reputational matters and mergers and acquisitions — all areas for which UnitedHealth has been in the public eye.
    • “Michele Hooper, who’s served on UnitedHealth’s board since 2007, will step down as lead independent director to chair the committee. Hooper, who will remain a director, will be replaced as lead independent director by F. William McNabb, the former CEO of investing firm the Vanguard Group who has served on UnitedHealth’s board since 2018.”
  • The International Foundation of Employee Benefit Plans discusses various GLP-1 coverage strategies.
  • Per Beckers Hospital Review,
    • “Philadelphia-based Temple Health has acquired Redeemer Health’s 20% stake in Chestnut Hill Hospital, giving the academic system an 80% ownership interest in the hospital.
    • “This was a planned transaction that comes approximately two and a half years after Chestnut Hill Hospital was acquired by an alliance consisting of Temple Health, [Meadowbrook, Pa.-based] Redeemer and the Philadelphia College of Osteopathic Medicine,” a spokesperson for the health system told Becker’s. “Temple Health manages Chestnut Hill Hospital and now has an 80% ownership stake in the hospital.”
    • “With the transaction, Redeemer has exited the alliance, while the Philadelphia College of Osteopathic Medicine retains a 20% ownership stake in the148-bed hospital.”
  • and
    • “Sacramento-based Sutter Health plans to close its Jackson, Calif.-based Sutter Amador Surgery Center on Oct. 3.
    • “In an open letter to the community, obtained by Becker’s, Sutter Amador Hospital CEO Michael Cureton, Sutter Amador Surgery Center’s ambulatory services administrator, Branden Nelson, and the surgery center’s executive of operations, Johnny Russell, said the outpatient surgery center closure will help “align resources with areas of growing need” in the community it serves.”
  • Radiology Business relates,
    • “A “hybrid” artificial intelligence strategy—using a combination of radiologist readers and standalone AI interpretation of cases—can cut rads’ workloads by nearly 40%, according to new research. 
    • “Such technology has shown great promise in boosting physician performance, including helping to triage scans requiring added attention. However, AI implementation in breast cancer screening remains limited for various reasons, amid concerns it may miss some relevant cases, experts wrote Tuesday in RSNA’s Radiology.” 
  • BioPharma Dive reports,
    • Gilead Sciences is deepening its investment in cancer cell therapy, announcing Thursday a deal to pay $350 million to buy privately held Interius BioTherapeutics for a technology designed to reprogram immune cells in patients’ bodies.
    • If successful, Interius’ “in vivo” approach could yield a simpler alternative to the CAR-T therapies Gilead’s Kite Pharma division have brought to market, each of which includes extravagant production processes that involve manipulating cells in a lab. 
    • Gilead spent $12 billion to buy Kite nearly a decade ago and, since then, has become a leader in CAR-T therapies. That business has sputtered recently amid declining demand and competition from other developers. But Gilead is still investing through acquisitions and partnerships, such as a collaboration with Arcellx in multiple myeloma.
  • and
    • “Sarepta on Thursday said it’s reached agreements that remove about $700 million from a pile of debt due in 2027.
    • “The private agreements with debt holders will allow Sarepta to exchange the 1.25% convertible senior notes due in 2027 for $602 million worth of 4.875% convertible senior notes due in 2030, up to 6.7 million shares of Sarepta stock and about $123 million in cash. Separately, the company entered into a private placement of about 1.4 million shares.
    • “The transaction “significantly enhances our balance sheet flexibility and strengthens our financial position,” Sarepta CEO Doug Ingram said in a statement. Sarepta will still have $450 million in existing convertible notes due in 2027.”
  • and
    • “Xoma Royalty Corp. is acquiring another struggling biotechnology company in further sign of interest among certain firms in buying floundering drugmakers and shutting them down.
    • “Xoma on Wednesday agreed to buy Mural Oncology, a cancer biotech once spun out of Alkermes. Per deal terms, a Xoma subsidiary will acquire Mural for $2.035 per share. Mural stockholders could get up to another $0.205 per share if the company’s net cash holdings at the deal’s closing exceeds $36.2 million.
    • “The deal values Mural at the level of its cash reserves and represents a roughly 13% premium to the company’s closing share price of $1.80 on Tuesday. Xoma will wind down Mural’s business afterwards, according to the announcement.
    • “In acquiring and liquidating Mural, Xoma is extending a pattern among certain firms and investors to shut down drug companies whose depressed share prices leave them worth less than their cash holdings. Historically, these biotech “zombies” would pivot to new projects or merge with another drug company. Of late, however, investors are heightening pressure on company boards to return cash to shareholders instead.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, NIH, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor, who is a lawyer, posted his latest blog entry today. The post is titled “Building Momentum Through Legal Wins.”
  • STAT News reports,
    • “US Health Secretary Robert F. Kennedy Jr.’s regulatory roadmap shows the Trump administration plans to continue efforts scaling back on gender-affirming care, advancing its Make America Healthy Again agenda, and restructuring how it grapples with Covid-19 vaccines.
    • “The US government on Friday posted the semi-annual regulatory agenda that details planned rulemaking for the Department of Health and Human Services, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and other federal health agencies.
    • “The agenda was originally posted online Friday morning but later was removed and replaced with an “under maintenance” message. The Office of Management and Budget’s press office did not immediately respond to an email seeking comment.”
  • The reginfo.gov website on which the semi-annual regulatory agenda is posted still says “The system is under maintenance. It will be back shortly” at 6 pm ET.
  • OPM circulated a last minute 2026 benefit change via this carrier letter (Dropbox link).
    • “For Plan Year 2026, chemical and surgical modification of an individual’s sex traits through medical interventions (to include “gender transition” services) will no longer be covered under the FEHB or PSHB Programs. This exclusion expands upon Carrier Letter 2025-01a and applies regardless of age.”
    • The letter also describes exceptions to this rule.
  • The Hill informs us,
    • “By the end of 2025, the Trump administration likely will have shed around 300,000 workers, Office of Personnel Management Director Scott Kupor told Reuters on Thursday.
    • “The mass departures, which Kupor claimed were largely accounted for by voluntary buyouts rather than firings, would constitute a 12.5 percent reduction of the federal workforce from when President Trump was inaugurated in January.”
  • Federal News Network reports,
    • “The Office of Personnel Management has officially canceled this year’s version of the signature survey that assesses governmentwide satisfaction and engagement levels of federal employees.
    • “In a memo distributed to agency chief human capital officers on Friday afternoon, obtained by Federal News Network, OPM said after initially only delaying the survey, it has now fully scrapped plans to conduct the 2025 Federal Employee Viewpoint Survey.”
  • The American Hospital Association tells us,
    • “The Centers for Medicare & Medicaid Services Innovation Center Aug. 12 released an FAQ on the Wasteful and Inappropriate Service Reduction Model, a six-year technology-enabled prior authorization program pilot. CMS will partner with third-party entities to implement the program for a specified list of services delivered to patients with Original Medicare. The FAQs address patient rights, the coverage review process for beneficiaries and providers, safeguarding against inappropriate denials, protecting patient data and more. The model begins Jan. 1.”
  • and
    • “The Health Resources and Services Administration has awarded more than $15 million in grants to 58 rural health organizations for four-year projects as part of the Federal Office of Rural Health Policy’s Rural Health Care Services Outreach program. The awardees must use innovative, evidence-informed models to address health care needs unique to their communities that are designed to expand access to care and improve health outcomes. The projects will be conducted by a local network of partnering organizations that may include rural hospitals, community-based organizations, health departments, schools, health centers, rural health clinics, academic institutions and other local and state entities.  
  • NCQA, writing in LinkedIn, informs us,
    • “NCQA and The Praxis Project are collaborating on a perinatal measure development project to create, validate and implement an actionable set of measures that align health plans toward improving perinatal health. The project team is developing up to eight new measures for potential inclusion in HEDIS® (Healthcare Effectiveness Data and Information Set) and in other national accountability programs.
    • “Currently, the teams are seeking testing partners—health plans, health systems, state agencies, community-based organizations, Federally Qualified Health Centers, birth centers—to help evaluate the feasibility, validity, reliability and usability of the new measures through a learning network, beginning this fall.”

From the Food and Drug Administration front,

  • BioPharma Dive lets us know,
    • “The Food and Drug Administration granted full approval to a first-of-its-kind treatment for recurrent respiratory papillomatosis, a rare and potentially life-threatening condition caused by persistent HPV infections. Thursday’s clearance of Precigen’s Papzimeos, an immunotherapy that helps clear HPV-infected cells, was based on study results showing a little more than half of drug recipients didn’t need surgery within a year of therapy. Center for Biologics Evaluation and Research director Vinay Prasad, who rejoined the FDA this week, described the approval as proof “randomized trials are not always needed to approve medical products.”
  • Cardiology Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about ongoing safety issues with a series of cannulae used to vent the left side of the heat during cardiopulmonary bypass surgery procedures. The agency’s alert includes dozens of lots of Medtronic’s DLP Left Heart Vent Catheters with malleable bodies and vented connectors. 
    • “The FDA put this early alert in place after receiving multiple reports of the catheters “resisting shape retention when being bent.” The devices were specifically designed to be easy to bend, holding their shape in a way that helps clinicians work in safe, efficient manner. When the devices fail to retain their shape, however, it can cause delays in care while a replacement catheter is located. 
    • “If the issue is not identified prior to use and the clinician uses the cannula, it may lead to abrasion and perforation (cuts),” according to the FDA’s advisory. “Perforation of critical heart tissue may potentially lead to death if it is complicated, unnoticed or untreated.”
    • “This issue has been linked to three serious injuries as of July 28. No patient deaths have been reported.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is going up across the country. 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 lets us know,
    • New survey data from the Centers for Disease Control and Prevention (CDC) shows that uptake of two vaccines routinely recommended for teens increased last year, while coverage with another recommended shot remained flat.
    • The data from the 2024 National Immunization Survey-Teen, published yesterday in Morbidity and Mortality Weekly Report, show that, among 16,325 US adolescents aged 13 to 17 years, coverage with more than one dose of the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine increased from 89.0% in 2023 to 91.3% in 2024. Coverage with one or more dose of the quadrivalent (four-strain) meningococcal conjugate vaccine (MenACWY) rose from 88.4% to 90.1%.
    • Coverage with one or more Tdap dose was 90% or higher in 39 states, while coverage with one or more MenACWY dose was 90% or higher in 30 states. The survey also found that coverage with other recommended and catch-up vaccines increased in 2024, including the meningococcal group B vaccine (up 4.5 percentage point among 17-year-olds); the measles, mumps, and rubella vaccine (a 1.3-percentage-point increase in 13- to 17-year-olds with 2 or more doses); and the hepatitis B vaccine (a 1.3-percentage-point increase in teens with 3 or more doses).
    • “These findings highlight progress in public health activities to improve vaccination coverage,” CDC researchers wrote.
    • “Human papillomavirus (HPV) vaccine coverage among teens remained unchanged for the third straight year, however, with 78.2% having received one or more doses and 62.9% reporting they were up to date with the HPV vaccine. Coverage with one or more HPV vaccine doses was 80% or higher in 26 states and the District of Columbia.”
  • MedPage Today relates,
    • “Genetic susceptibility accounts for 20% of ovarian cancer risk, and risk-reducing bilateral salpingectomy remains the gold standard for prevention.
    • “In this study, about 24% of patients with high-grade serous ovarian cancer had missed opportunities for risk-reducing surgery before cancer diagnosis.
    • “Among the women with a first-degree family history of ovarian cancer, 43.2% had mutations that increased susceptibility to ovarian cancer.”
  • and
    • “A BMJ guideline put patient risk into the equation for assessing the suitability of SGLT-2 inhibitors and GLP-1 receptor agonist drugs for type 2 diabetes.
    • “Their use in type 2 diabetes was only strongly recommended for people at higher risk of cardiovascular and kidney complications.
    • “Meanwhile, these costly medications continue to be used more and more in the U.S. for a variety of indications.”
  • The AHA News points out,
    • “The American Heart Association and American College of Cardiology Aug. 14 released new guidelines on high blood pressure prevention, suggesting earlier treatment can reduce the risk of cognitive decline and dementia, as well as cardiovascular disease, stroke and kidney disease. The new guidelines replace those issued in 2017 and include new or updated recommendations for medication options and managing high blood pressure before, during and after pregnancy. The guidelines also reinforce the importance of healthy lifestyle behaviors such as eating a nutritious diet, being physically active, and maintaining or achieving a healthy weight.”
  • Per an NIH news release,
    • “Scientists at the National Institutes of Health (NIH) successfully reduced the severity of late-onset Tay-Sachs (LOTS) disease in human cell cultures and a mouse model by using a novel gene-editing treatment. LOTS is a rare form of Tay-Sachs disease, with signs and symptoms such as muscle weakness, loss of coordination, muscle spasms, and sometimes loss of mental function beginning in late childhood to adulthood. Similar disorders for which this breakthrough has implications include GM1 gangliosidosis, Sandhoff disease, Niemann-Pick disease, Krabbe disease and Gaucher disease.
    • “LOTS is a genetic disorder caused by a mutation in the HEXA gene that causes a deficiency of an enzyme that is critical to breaking down a fatty substance in the brain, known as GM2 ganglioside. The buildup of this fatty substance damages nerve cells in the brain and spinal cord. The amount of enzyme still being produced by the body affects the severity of the disease and the age of onset. By deploying the correction to the HEXA gene, scientists were able to increase the activity of the enzyme, known as beta-hexosaminidase A, delay symptom onset and significantly extend lifespan in the mouse model.
    • “With LOTS, a slight correction will go a long way. This editing may only need to increase enzyme activity by about 10% to keep symptoms from getting worse, and improve their quality of life,” said paper author Dr. Richard Proia of NIH’s National Institute of Diabetes and Digestive and Kidney Diseases. “We’ve figured out that opening the door to increased enzyme activity is possible, now we have to figure out how to do it in a person.”

From the U.S. healthcare business front,

  • Reuters reports,
    • “Shares of UnitedHealth Group (UNH.N), opens new tab surged nearly 14% on Friday after billionaire Warren Buffett’s Berkshire Hathaway (BRKa.N), opens new tab bought 5 million shares of the company, providing a shot in the arm for investors who think the health conglomerate will turn around under its new CEO.
    • “The shares have lost nearly half their value in the last year as the company struggled to adapt to rising healthcare costs and changes to government reimbursement plans that affected its health insurance and Optum patient care businesses.”
  • The Wall Street Journal relates,
    • “Nike co-founder Phil Knight and his wife, Penny Knight, are donating $2 billion to Oregon Health & Science University’s Knight Cancer Institute—the largest known single gift to a U.S. university, coming at a time when colleges’ public funding is under siege.
    • “The gift will roughly double the size of the cancer center, expanding its capacity to treat patients and conduct research. 
    • “The effort will be led by Dr. Brian Druker, a cancer-research pioneer known for developing Gleevec, a drug that transformed the survival of patients with chronic myeloid leukemia, a cancer of the blood and bone marrow. Druker, an OHSU professor who led the Knight Cancer Institute as chief executive officer until December, will return as the organization’s president. 
    • “We couldn’t be more excited about the transformational potential of this work for humanity,” the Knights said in a news release Thursday.”
  • Per Beckers Hospital Review,
    • “Hospitals and health systems are preparing for a rise in high-risk pregnancies, even as many labor and delivery units shut down. 
    • “Vizient company Sg2 projected that the proportion of high-risk pregnancies will accelerate alongside a rise in obesity-related comorbidities, including high blood pressure and diabetes. 
    • “Baptist Medical Center Jacksonville, part of Jacksonville, Fla.-based Baptist Health, is expanding its labor and delivery services in preparation for a 14.5% increase in high-risk pregnancies over the next decade, NPR affiliate WUSF reported Aug. 14. 
    • “The conundrum is this: Multiple health systems and hospitals are ending labor and delivery services, citing a decrease in birth rates, financial challenges and a workforce shortage. And although the national birth rate is declining, neonatal ICU admissions are increasing.
    • “There are a few factors contributing to the trend, including better survival rates of premature infants, an advancing maternal age and a rise in chronic maternal conditions. 
    • “In response to this trend, a different system of the same name, Little Rock, Ark.-based Baptist Health, announced in June an effort to improve maternal and children health outcomes for high-risk pregnancies. The initiative is Nashville, Tenn.-based Vanderbilt University’s Maternal Infant Health Outreach Worker Program, which targets economically disadvantaged and geographically isolated communities.” 
  • Per MedTech Dive,
    • “Oracle Health is releasing a new artificial intelligence-backed electronic health record, months after the technology giant first teased the “next generation” system.
    • “The EHR allows clinicians to use voice commands to access information, like a patient’s latest lab results or a list of current medications, cutting down the amount of time providers spend navigating through health records, the technology giant said in a press release Wednesday. 
    • “The AI-backed product is now available for ambulatory providers in the U.S., pending certification by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT, Bharat Sutariya, SVP and chief health officer at Oracle Health, told Healthcare Dive. Oracle plans to launch functionality for the acute care market in 2026.” 

Midweek Update

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Today, the Government Accountability Office released a report on priority open recommendations made to the U.S. Office of Personnel Management.
    • “In May 2024, GAO identified 16 priority recommendations for the Office of Personnel Management (OPM). Since then, OPM has implemented three of those recommendations.
      • Specifically, OPM took actions to better mitigate cybersecurity risks, improve its payroll database, and strengthen privacy protections for personally identifiable information on its IT systems.
    • In August 2025, GAO identified one additional priority recommendation for OPM, bringing the total number to 14. These recommendations involve the following areas:
      • preventing improper payments,
      • strengthening IT security and management,
      • addressing mission critical skills gaps,
      • improving the federal classification system,
      • making hiring authorities more effective,
      • improving payroll data, and
      • addressing employee misconduct and improving performance management.
    • OPM’s continued attention to these issues could lead to significant improvements in government operations.
  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) this week released new data fueling a narrative of rampant broker fraud on the Affordable Care Act (ACA) exchanges.
    • “Plans received data finding 23% of enrollees did not have a claim in 2019. That number jumped sharply to 35% last year.
    • “Before the pandemic, the data were largely consistent across three categories: members on state-based exchanges, members on the federal exchange in Medicaid expansion states and on the federal exchange in non-expansion states. No matter the group, about 22% to 24% of enrollees did not have a claim.
    • “But, by 2024, expansion states on the federal exchange saw an increase from 22% to 32%, and the non-expansion population jumped from 24% to 41% without a claim, according to the agency’s data. Meanwhile, enrollees on state-based exchanges without claims climbed modestly from 22% to 24%.”
  • The suspicion is that brokers have been adding phantom enrollees to highly federal government subsidized silver and bronze plans.
    • The Paragon Health Institute adds,
      • “As Paragon discussed in our The Great Obamacare Enrollment Fraud series, large-scale fraud schemes have led to people enrolling in exchange plans without their knowledge, and others being misled by false offers of cash or gift cards to apply for insurance. A few months ago, a Bloomberg exposé revealed fraud rings in Florida, including brokers earning thousands daily by enrolling people who often had no idea.”
  • An HHS news release features a trip that HHS Secretary Robert F. Kennedy took to Alaska last week to highlight rural and tribal health priorities.
  • Beckers Health IT considers whether the Trump administration can achieve its goal of doing away with clipboards in healthcare. It’s worth pointing out
    • “Curtis Cole, MD, vice president and chief global information officer of Ithaca, N.Y.-based Cornell University, said he’s “hopeful that something positive” will come from the plan, but he’s not “particularly sanguine.”
    • “A lot of it looks like the all-too-frequent use of computers to make bad processes work faster, rather than fixing the fundamental problem,” he said.
    • “He pointed to the lack of a national patient identifier, which other developed nations have. The Trump administration is advocating for digital identity verification to link patients to their records, but Dr. Cole says those systems often have incorrect or incomplete information.”
  • HIPAA, a 1996 federal law, calls for HHS to create a national patient identifier but Congress has blocked funding for that initiative. 
  • STAT News reports,
    • “A handful of drug companies have formed a group to present lawmakers with research on what the industry sees as the negative impacts of Medicare drug price negotiations, according to lobbying records.
    • “The group is called the IRA Watchdog after the Inflation Reduction Act, which directed Medicare to negotiate the prices for some drugs. Its members are Merck, AstraZeneca, Bristol Myers Squibb Company, and Eli Lilly, according to lobbying disclosure records. The group describes itself as a “coalition analyzing the impact of Medicare Drug Price Negotiation on patients.” * * *
    • “The IRA Watchdog is not a stand-alone lobbying organization. It’s housed in the firm DLA Piper, and its two lobbyists were staffers for former Sen. Richard Burr (R-N.C.), who while in Congress championed the biotech sector, a key driver of the economy in his home state. Burr is a senior policy adviser at DLA Piper and the chair of its health policy strategic consulting practice.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Insmed has gained approval for its second lung disease medicine, announcing Tuesday Food and Drug Administration clearance of Brinsupri to treat a chronic condition that results in dilated airways in the lungs, chronic cough and frequent respiratory infections.
    • “Brinsupri is the first drug to treat bronchiectasis not caused by cystic fibrosis and the first in a new class of drugs called DPP-1 inhibitors that could treat multiple inflammatory conditions. Startup Expedition Therapeutics just signed a deal with Fosun Pharma for most rights to a DPP-1 inhibitor, while Boehringer Ingelheim and Haisco Pharmaceutical Group have drugs in development.
    • “Wall Street analysts forecast as much as $6 billion in annual sales for Brinsupri. Insmed’s market valuation has swelled to more than $25 billion in anticipation of coming sales from Brinsupri, its other approved drug Arikayce and pipeline candidates in lung disease and Duchenne muscular dystrophy.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “Fewer Americans are reporting that they drink alcohol amid a growing belief that even moderate alcohol consumption is a health risk, according to a Gallup pollopens in a new tab or window released Wednesday.
    • “A record high percentage of U.S. adults, 53%, now say moderate drinking is bad for their health, up from 28% in 2015. The uptick in doubt about alcohol’s benefits is largely driven by young adults — the age group most likely to believe drinking “one or two drinks a day” can cause health hazards — but older adults are also now increasingly likely to think moderate drinking carries risks.
    • “As concerns about health impacts rise, fewer Americans are reporting that they drink. The survey found that 54% of U.S. adults said they drink alcoholic beverages such as liquor, wine, or beer. That’s lower than at any other point in the past three decades.
    • “The findings of the poll, which was conducted in July, indicate that after years of many believing that moderate drinking was harmless — or even beneficial — worries about alcohol consumption are taking hold. According to Gallup’s data, even those who consume alcohol are drinking less.”
  • Health Day informs us,
    • “Nearly 70 percent of U.S. children in car crashes with a fatality are not using proper child passenger restraints, according to a study published online July 31 in Traffic Injury Prevention.
    • “Arthi S. Kozhumam, from the Northwestern University Feinberg School of Medicine in Chicago, and colleagues identified child, driver, vehicle, neighborhood, and policy-level factors associated with suboptimal child passenger safety practices in motor vehicle collisions (MVCs) with a fatality. The analysis included data from child passengers (younger than 13 years old) in cars and light trucks with known restraint status and seating location identified from the Fatality Analysis Reporting System database (2011 to 2021).”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-supported clinical trial has found that the outcome of treating complicated Staphylococcus aureus bloodstream infections with two intravenous (IV) doses of the antibiotic dalbavancin seven days apart is just as good as daily IV doses of conventional antibiotics over four to six weeks. Nearly 120,000 S. aureus bloodstream infections and 20,000 associated deaths occurred in the United States in 2017. The study results provide the clearest evidence to date for the safety and effectiveness of dalbavancin therapy for complicated S. aureus bloodstream infections, expanding the number of antimicrobial treatment options for clinicians and patients. The findings were published today in the Journal of the American Medical Association.
    • “Given the small number of antimicrobial drugs available to treat Staphylococcus aureus bloodstream infections and the bacteria’s growing drug resistance, establishing dalbavancin as a beneficial therapy for these severe infections gives us a vital new alternative to treat them,” said John Beigel, M.D., the acting director of the Division of Microbiology and Infectious Diseases at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which sponsored and funded the trial.”
  • Medscape offers “Perspectives on Managing Antibiotic Resistance.”
  • Per MedPage Today,
    • “Men had higher mortality and hospitalization rates than women after a dementia diagnosis.
    • “These relationships held even after controlling for age and comorbidity burden.
    • “The study was based on over 5.7 million Medicare patients with up to 8 years of follow-up.”
  • and
    • “Applying five published definitions for long COVID yielded a prevalence that ranged from 30.84% to 42.01% at 3 months and 14.23% to 21.94% at 6 months.
    • “Up to a third of the variation in prevalence rates could be attributed to the differences in long COVID definitions.
    • “While ideal, there may never be a single, standardized long COVID definition, given the divergent needs of researchers and clinicians.”
  • and
    • “Clear” e-cigarettes had disproportionately greater cardiovascular effects than other types of vapes when smoking conditions were controlled.
    • “Clear” e-cigarettes contained synthetic coolants, menthol, and other flavorings despite their marketing.
    • “Acute increases in blood pressure may be related to the synthetic coolants reducing tobacco or nicotine harshness and facilitating deeper inhalation.”
  • The National Institute of Standards and Technology explains why “Wearable, Implantable and Ingestible Medical Devices Could Revolutionize Your Health Care.”
  • Genetic Engineering and Biotechnology reports,
    • “Targeted DNA editing by CRISPR technology has great potential for applications in biotechnology and gene therapy. However, precise gene editing remains a challenge largely due to insufficient control of the DNA repair process. While mechanisms exist to accurately repair double-stranded breaks, DNA end joining repair can occasionally lead to genetic errors.  
    • “In a new study published in Nature Biotechnology titled, “Precise, predictable genome integrations by deep learning–assisted design of microhomology-based templates,” researchers at the University of Zurich (UZH) have found that repair at the genome-cargo interface is predictable by artificial intelligence (AI) models and adheres to sequence-context-specific rules. The AI tool, named “Pythia,” predicts how cells repair their DNA after it is cut by CRISPR/Cas9 and opens the door to more accurate modeling of human diseases and next-generation gene therapies. 
    • “Just as meteorologists use AI to predict the weather, we are using it to forecast how cells will respond to genetic interventions. That kind of predictive power is essential if we want gene editing to be safe, reliable, and clinically useful,” said Soeren Lienkamp, PhD, professor at the Institute of Anatomy of UZH and co-corresponding author of the study.” 

From the U.S. healthcare business front,

  • Fierce Healthcare relates,
    • “Providence posted a $21 million operating loss (-0.3% operating margin) for the second quarter of the year as elevated volumes and revenues outpaced year-over-year expense increases.
    • “The operating performance is an improvement over the prior year’s $123 million operating loss (-1.6% operating margin), for which the 51-hospital nonprofit credited its “continued focus on staffing and reductions from expense management initiatives.” The system is sitting at a $265 million operating loss (-1.7% operating margin) across six months.
    • “Providence executives cheered the system’s steady march toward breakeven after several consecutive years of losses.
    • “Still, the organization stressed a slew of economic headwinds it refers to as a “polycrisis” affecting nonprofit health systems like Providence as cause for continued expense reduction. Among these are inflation, tariffs, new state regulations around staffing and charity care, payment delays from commercial payers and the impending federal funding cuts of the “one big, beautiful bill.” 
  • and
    • “Health tech and artificial intelligence companies see ripe opportunities to offer solutions that help patients access and share their medical data with digital health apps. And it comes at a time when the federal government is pushing for consumer-directed data exchange.
    • “HealthEx, a company that built data rights management solutions, launched a platform to provide real-time patient access to complete health records. The company worked with a team of industry partners to develop a process that verifies patient identity, captures consent and retrieves clinical records, enabling the data to flow without the patient doing multiple patient portal logins.
    • “The company aims to create an “Apple Wallet” for health records, executives said.
    • “CLEAR, an identity verification tech company often found at airports, worked with HealthEx on the initiative, along with national electronic health record company athenahealth, healthcare interoperability company MedAllies and the CommonWell Health Alliance.”
  • Beckers Hospital Review points out,
    • “Three-quarters of the hospitals on U.S. News & World Report’s 2025-26 Honor Roll list also earned top marks in CMS’ latest Overall Hospital Quality Star Ratings, underscoring a notable overlap in national measures of hospital excellence. 
    • “CMS released its 2025 star ratings Aug. 6, evaluating more than 4,600 hospitals nationwide on 46 quality measures spanning mortality, safety, patient experience, readmissions, and timely and effective care. This year, 290 hospitals earned a five-star rating. U.S. News published its 2025-26 Honor Roll on July 29, recognizing 20 hospitals for top performance across 15 specialties and 22 procedures and conditions.
    • “While the two lists use different methodologies and scoring systems, their alignment highlights organizations that excel across quality- and reputation-based benchmarks.”
  • Beckers Payer Issues notes,
    • “Optum has acquired Kingsport, Tenn.-based Holston Medical Group, WJHL reported Aug. 11. 
    • “The 200-provider medical group has more than 70 locations in Northeast Tennessee and Southwest Virginia, according to the report. 
    • “Holston Medical Group is pleased to join Optum to support our efforts to continue to provide exceptional health care services to patients in the communities we serve,” an Optum spokesperson said in a statement shared with the news outlet. “Holston Medical Group and Optum share common goals around providing patients with high-quality, local care with a focus on value and innovation. We look forward to the breadth of clinical expertise and capabilities that we will gain as part of Optum.”
  • Per BioPharma Dive,
    • “PureTech Health, a biotechnology firm with a web of startup subsidiaries, announced Tuesday the launch of a new company that will develop a respiratory disease treatment it’s been advancing through clinical testing.
    • “Called Celea Therapeutics, the company debuts with a drug candidate nearing late-stage trials that the company believes could treat multiple inflammatory lung diseases. Known as deupirfenidone or LYT-100, the drug is initially being evaluated against idiopathic pulmonary fibrosis, a rare and chronic condition. 
    • “Sven Dethlefs, who has spearheaded the deupirfenidone program under PureTech over the last year, will lead Celea. Prior to joining PureTech, Dethlefs was the CEO of Teva North America, where he oversaw the company’s specialty and generic businesses in the U.S. and Canada.”
  • Per MedTech Dive,
    • “Heartflow’s initial public offering grossed $364.2 million after the volume and price of the shares sold exceeded the original expectations.
    • “The company listed last week and completed the sale of the overallotment on Monday, adding almost $50 million through the sale of additional shares.
    • “Heartflow’s stock rose in its first two days on public markets, closing at almost $30 on Monday. The company priced its IPO at $19 a share.
    • “Heartflow has developed software for making 3D heart models from coronary computed tomography angiography scans. In a clinical trial, the company linked its lead product, Heartflow FFRCT Analysis, to a 78% improvement in identifying patients in need of revascularization.”

Tuesday report

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.”

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.”