Midweek Update

NIH

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.”

Tuesday report

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

From Washington, DC

  • Roll Call reports,
    • “No more votes are scheduled beyond Wednesday in the House, a change from the previous schedule that reflects a Rules Committee dispute over release of the Jeffrey Epstein case files that will prevent any rules for debate from coming to the floor.
    • “The House is expected to continue to consider legislation under suspension of the rules through Wednesday afternoon but won’t have any more floor votes on Thursday.
    • “That’s a shift from Monday night when Speaker Mike Johnson, R-La., told reporters that the chamber would remain in session through Thursday because of suspension votes and committee meetings.”
  • Because the House of Representatives is scheduled to be on an August recess until September 2, 2025, the House Appropriations Committee will not be taking up the FY 2025 Financial Services and General Government appropriations bill until September.
  • The American Hospital Association News tells us, “The House Ways and Means Subcommittees on Health and Oversight held a joint hearing today to discuss lessons learned, challenges and opportunities to improve the Medicare Advantage program,” and “The AHA today expressed support for the Medicare Mental Health Inpatient Equity Act, a bill that would eliminate the 190-day lifetime limit on inpatient psychiatric hospital services for Medicare patients.” 
  • STAT News adds,
    • “Members of a [House Energy and Commerce oversight committee] said Tuesday that they fear public trust in organ donation has been fractured after a federal report found that an organ procurement organization ignored signs of life in patients when authorizing attempted organ removals.
    • “The hearing followed a federal investigation by the Health Resources and Services Administration that found that a group responsible for overseeing the removal of organs from deceased patients and getting them to patients in need exhibited “concerning patterns of risk to neurologically injured patients.” * * *
    • “During Tuesday’s hearing, lawmakers sharply questioned and criticized the practices of Network for Hope, the OPTN, and UNOS in conducting oversight of patient safety. The OPTN had launched a separate investigation into Network for Hope that was closed without further action.” 
  • Govexec informs us,
    • “The new, Senate-confirmed head of the Office of Personnel Management, venture capital alum Scott Kupor, says that he wants to operationalize the focus on efficiency in his agency and throughout government, but that OPM won’t be taking orders from the Department of Government Efficiency.
    • “OPM is its own agency,” Kupor told reporters Monday when asked about its relationship with DOGE moving forward. “To the extent that they’re helpful in the overall goals and objectives we have, then we’re happy to partner with people, but we’re going to ultimately make the decisions that we think are in the best interests of OPM.” * * *
    • “The agency is down by 322 employees since the start of Trump 2.0, OPM says. Once voluntary separations are finalized by the end of the year, OPM will be down from 3,110 employees when Trump took office to about 2,000, or around one-third of the agency, according to OPM.” * * *
    • “Kupor, who only started the job last week, said that he may have to make up for some of those losses. The agency is looking at what gaps in service exist, which need to be filled, which can be made up for with technology and what was “nice to have,” but not essential.” * * *
    • “We’ve got to really just rethink our entire recruiting efforts,” Kupor said. “I want every really smart person in this country to wake up every day and say, ‘you know what, I want to go work for the government because I can work on super hard problems that are very complex.’”
  • The AHA News relates,
    • “The AHA yesterday responded to a request for information from the Centers for Medicare & Medicaid Services on price transparency policy, specifically the accuracy and completeness of hospitals’ machine-readable files. The AHA said that determining the accuracy and completeness of machine-readable file data is challenging given that exact rates do not exist in the way they were envisioned by the policy. In addition, the AHA said that additional enforcement of hospital price transparency requirements is not necessary due to CMS’ improved enforcement efforts.  
    • “The AHA encouraged CMS to instead focus its efforts on the information that will best help patients understand and compare their expected costs prior to care and on streamlining price transparency policies to remove complexity and administrative burden.”

From the Food and Drug Administration front,

  • MedPage Today points out,
    • “Women should be better informed about the potential risks of using selective serotonin reuptake inhibitors (SSRIs) during pregnancy, and these risks should be weighed against their benefits, most speakers on an FDA panel selected by Commissioner Marty Makary, MD, MPH, agreed on Monday.
    • “Up to 5% of women in pregnancy are on an antidepressant. Antidepressants like SSRIs can be an effective treatment for depression,” said Makary during his opening remarks, though he warned that SSRIs “may be unique” because of their potential interaction with pregnancy.
    • “Serotonin may play a crucial role in the development of organs of a baby in utero, specifically heart, brain, and even the gut,” he continued. “SSRIs have also been implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertension, and cognitive downstream effects in the baby, as well as cardiac birth defects.”
  • STAT News reports,
    • “Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy that is being temporarily shelved because of safety concerns, faces an “arduous and treacherous path” to try to get it back onto the market, a senior Food and Drug Administration official told STAT, suggesting the treatment’s license could be revoked. 
    • “The official, who spoke to STAT on condition of anonymity, did not rule out the possibility that the therapy, Elevidys, could eventually be brought back on the market. But it would be difficult for Sarepta to prove that any new safety protocols could eliminate the risk of liver injuries — which have been tied to the deaths of two patients — the official added.”

From the judicial front,

  • The Chief Judge for the Southern District of Iowa federal court entered a preliminary injunction today against certain provisions of a recently enacted Iowa PBM reform law that interfere with operations of ERISA governed health plans based on ERISA’s preemption law. The 87-page decision is well reasoned and quite balanced. What’s good for ERISA preemption is good for FEHB Act preemption.
  • Healthcare Dive reports,
    • “Humana on Monday refiled its lawsuit against the federal government for allegedly miscalculating its Medicare Advantage quality scores for 2025, after its previous suit was dismissed on procedural grounds.
    • “The new suit in a Texas district court is slimmer than its predecessor, focusing on allegations that regulators improperly dinged its plans’ star ratings on the basis of three mishandled customer service phone calls. The original suit made broader arguments about the integrity of the star ratings system and review process.”

From the public health and medical research front,

  • Cigna, writing in LinkedIn, discusses “the importance of treating both mental and physical health together.
  • USA Today lets us know,
    • “About five million swimming pools, specifically above-ground pools, have been recalled for a potential drowning risk after nine children died in a 15-year span.
    • “The impacted models include 48-inch and taller above-ground pools sold over the past two decades under the brand names Bestway, Coleman, Intex, and Polygroup, according to a release from the U.S. Consumer Product Safety Commission
    • “The CPSC believes between 2007 and 2022, nine children under 3 years old drowned after gaining access to the pools via compression straps that wrap around the outside of the product, according to the release.
    • “These straps wrap around the pool on the outside of the supporting poles, and may create a foothold, allowing a child to access the pool and drown,” the release said.”
  • STAT News reports,
    • “People suffering from long Covid finally had reason for hope: A German biotech had repurposed a drug candidate initially meant for heart disease as a potential treatment and enrolled patients in a rare double-blind Phase 2 study. For some participants, the results were transformative. One patient told Betsy Ladyzhets of The Sick Times that thanks to the infusion, BC 007, “I have literally regained life.”
    • “But last fall, the biotech company Berlin Cures abruptly announced the trial results were a failure, that it was out of money, and that it was done researching BC 007 as a treatment for long Covid. The story serves as a case study in the difficulty of developing long Covid therapies, as well as a window into the real-world impacts the hope and pain that clinical trials can inspire as they ramp up and then suddenly vanish. However, the drug may still have a future. Read more.“
  • and
    • “People with diabetes who were just a little physically active in their leisure time reduced their risk of dying from any cause — and from cardiovascular disease in particular — compared to people who weren’t active at all, according to a new Annals of Internal Medicine study that followed more than 51,000 people for 21 years. That benefit showed up for people who met the American Diabetes Association’s recommended 150 minutes of moderate to vigorous exercise a week over at least three days, but it was also apparent for “weekend warriors” who hit 150 minutes in just two days, matching research in people without diabetes. “Insufficiently active” types whose activity fell short of the 150 minutes per week also fared better than those who did no exercise.”
  • Per Medscape,
    • “Patients treated with tirzepatide have a significantly increased likelihood of attaining combined key therapeutic targets in the control of type 2 diabetes (T2D) compared with semaglutide, a post hoc analysis of the phase 3 SURPASS-2 trial showed. 
    • “In this post hoc analysis, we showed that tirzepatide was superior to semaglutide in achieving standard and intensive goals in type 2 diabetes control,” said first author Ana Rita Leite, MD, of the Department of Endocrinology, Diabetes, and Metabolism, São João Local Health Unit, Porto, Portugal, in presenting the findings at ENDO 2025: The Endocrine Society Annual Meeting.
    • “All doses of tirzepatide were superior in achieving these goals compared with semaglutide 1 mg, and there was a dose-dependent increase in the number of therapeutic goals attained with higher doses of tirzepatide,” she said.”
  • Per Health Exec,
    • “Researchers at the University of Florida College of Medicine have made a surprising finding that they say could “wake up” the immune system to fight cancer, possibly leading to a universal vaccine. 
    • “According to an announcement, a new study showed that an experimental vaccine developed using mRNA technology boosted tumor resistance in mice, when compared to a cohort that was given standard anti-cancer drugs. 
    • “The results seem to indicate the mice given the vaccine developed an immune response that allowed them to more effectively resist cancerous tumors. The findings were published in Nature Biomedical Engineering. [1]
    • “The promising results have spurred interest in how humans would react to the mRNA vaccine, with the researchers hoping it could be used as a treatment, either by itself or in conjunction with surgery, radiation and chemotherapy.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ahead of the company’s second-quarter earnings call Aug. 6, Oscar Health is slashing its full-year guidance by about half a billion dollars.
    • “The insurer is expecting a loss from operations of $200 million to $300 million just months after estimating earnings from operations of $225 million to $275 million, partly due to elevated utilization.
    • “Oscar’s medical loss ratio is also climbing to between 86% and 87%, more than 5% higher than initially proposed. Total revenue is projected to climb to no more than $12.2 million.
    • “Wakely, an actuarial firm analyzing claims submissions through the end of April for Affordable Care Act (ACA) marketplace carriers, determined marketplace risk scores have risen more than Oscar previously estimated. The company foresees a net loss of $228 million for the second quarter.
    • “We are taking appropriate pricing actions for 2026 that reflect higher acuity in the individual market, and we will continue to take steps to deliver for our members, partners, and shareholders,” said Oscar Health CEO Mark Bertolini in a statement. “Oscar has successfully navigated dynamic markets before, and we remain committed to our long-term strategy to bring more employees, individuals, and families healthcare choices that fit their needs through the individual market.”
  • Per Drug Channels,
    • “It’s time for Drug Channels’ annual update on drug pricing trends at the largest pharmaceutical manufacturers.
    • “This year’s review includes the following nine companies: Bristol Myers Squibb, Eli Lilly and Company, Genentech, GlaxoSmithKline, Johnson & Johnson, Sanofi, Takeda, Teva, and UCB. You can find links to each company’s data below.
    • “These data highlight divergent trends reshaping the gross-to-net bubble:
      • “Rebates, discounts, and other fees reduced the selling prices of brand-name drugs at the biggest drugmakers to less than half of their list prices.
      • “When accounting for all list price reductions, average brand-name drug prices declined at four manufacturers and increased at five others. 
      • “Gross-to-net difference in price changes ranged from −12.8% to +4.2%, reflecting significant differences in the manufacturers’ portfolio mix and pricing strategies.”
  • Fierce Health adds,
    • “Humana is accelerating its efforts to reform the prior authorization process through a series of new policies, following the broader insurance industry’s recent pledge to reduce and streamline prior auth requirements.
    • “By January 1, 2026, Humana will eliminate one-third of prior authorization requirements for outpatient services, including for diagnostic services across colonoscopies, transthoracic echocardiograms, and select CT scans and MRIs. 
    • “Under the same timeline, the company is committing to providing decisions within one business day on at least 95% of all complete electronic prior authorization requests. Currently, a decision is provided within one business day on more than 85% of outpatient procedures.
    • “Also in 2026, Humana will launch a new gold card program that waives prior authorization requirements for certain items and services for providers with a record of submitting 
    • coverage requests that meet medical criteria and specific outcomes metrics for members.”
  • Fierce Pharma tells us,
    • “With the threat of tariffs looming for medicines imported to the United States, AstraZeneca has unveiled a plan to invest $50 billion in the country by 2030. The centerpiece of the effort is a drug substance manufacturing facility—the highest-priced plant in company history—that will be located at a yet-to-be-determined site in Virginia.
    • “The massive investment is part of a push by the company to generate $80 billion in sales by the end of the decade, with 50% of the haul coming in the United States. Last year, the British/Swedish company reported revenue of $54 billion, with U.S. sales accounting for 42% of the figure.”
  • BioPharma Dive reports,
    • “French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 billion to acquire the privately held London-based private biotechnology company Vicebio and its portfolio of experimental vaccines.
    • “Through the deal, Sanofi will gain a combination shot now in clinical testing for protection against respiratory syncytial virus and human metapneumovirus, or hMPV. Vicebio specializes in a vaccine technology it dubs “molecular clamp.”
    • “Per deal terms, Vicebio could also receive up to $450 million in additional payments based on achievement of developmental and regulatory milestones. The companies expect the acquisition to close in the fourth quarter.”

Friday report

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

From Washington, DC,

  • Govexec reports,
    • “President Trump created another new category of federal employee on Thursday evening, issuing an executive order to expand the number of political appointees who do not require Senate confirmation and will serve in policy-making or policy-advocating roles. 
    • ‘While presidents can already tap an uncapped number of appointees to serve in Schedule C positions, Trump noted those individuals serve in more narrow confidential or policy-determining roles. The new positions will therefore fill a gap that currently exists in federal appointments, the White House said. 
    • “The order is the latest in Trump’s effort to establish a tighter grip on the executive branch and its actions. He has already created Schedule Policy/Career, formerly known as Schedule F, which is similarly defined to Schedule G but reserved for career civil servants. Agencies are in the process of determining who qualifies for conversion to Schedule Policy/Career and those employees will become easier to fire for any reason.” 
  • Federal News Network tells us,
    • “The Postal Service’s new chief executive is defending the agency’s current operating model, at a time when the Trump administration considers challenging its independence.
    • “David Steiner, former FedEx board member and Waste Management CEO, began his tenure as postmaster general on Tuesday.
    • “Steiner told employees Thursday he supports keeping USPS independent from the executive branch and defended the 10-year reform plan of his predecessor, former Postmaster General Louis DeJoy.
    • “Steiner told employees in a video message on Thursday that, “I do not believe that the Postal Service should be privatized, or that it should become an appropriated part of the federal government.”
    • “I believe in the current structure of the Postal Service as a self-financing, independent entity of the executive branch,” Steiner said. “My goal for the Postal Service is to meet the financial and service performance expectations of our nation under this structure.”
  • The American Hospital Association News informs us,
    • “Health Insurance Marketplace insurers will propose a median premium increase of 15% for 2026, according to an analysis of preliminary rate filings published July 18 by the Peterson Center on Healthcare and KFF. It would be the largest hike in premiums since 2018, the report said. Factors cited for the increase include the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The analysis found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase the cost of certain drugs, medical equipment and supplies.”
  • The Centers for Medicare and Medicaid Services shares highlights from its 2025 Quality Conference held earlier this month.
  • KFF, writing in Fierce Healthcare, criticizes the No Surprises Act. No law is perfect.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive.
    • “Sarepta last month paused shipments for certain older Duchenne patients following the death from acute liver failure of a second teenager treated with the therapy, called Elevidys. The FDA subsequently began a formal investigation of Elevidys’ liver risks. 
    • “Reuters first reported news of the FDA’s request. FDA Commissioner Martin Makary told Bloomberg in an interview Friday that his agency is weighing whether to withdraw Elevidys from the market entirely. 
    • “The news comes on the heels of Sarepta reporting this week the death of a 51-year-old man who received an experimental gene therapy it’s developing for another kind of muscular dystrophy known as limb-girdle. The man died of complications from acute liver failure in June. 
    • “While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles.”
  • The New York Times adds,
    • In a remarkable public dispute between drugmaker and regulator, the biotech company Sarepta Therapeutics is defying the Food and Drug Administration’s request that it halt distribution of its treatment for a deadly muscle-wasting disease.
    • In a news release on Friday evening, the agency said that it requested that the company voluntarily stop all shipments of the therapy, known as Ele­vidys, citing the deaths of three patients from liver failure who had taken the product or a similar therapy.
    • In its own news release later on Friday evening, Sarepta, which is based in Cambridge, Mass., said that it would continue to ship the treatment for patients who do not use wheelchairs. The company said its analysis showed no new safety problems in those patients and that it was committed to patient safety.
  • BioPharma Dive points out,
    • “A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a meeting convened Thursday by the Food and Drug Administration.
    • “Led by FDA Commissioner Martin Makary, the meeting focused on the benefits and risks of menopause hormone therapy, or MHT, which has become a controversial topic due to mixed study data.
    • “The panel, which consisted of 12 experts with various medical backgrounds, took a generally positive view of MHT and described situations in which patients experienced severe symptoms could not get access to treatment.”
  • Healthexec notes,
    • “The U.S. Food and Drug Administration announced a recall of multiple active glucose monitoring units manufactured by Dexcom due to a malfunction in the receivers. The speakers on these devices may fail to alert wearers when blood sugar levels become dangerously high or low. Typically, the monitors emit an alert sound; however, in Dexcom G6, G7, ONE and ONE+ products, reports indicate that the alarms do not always function properly.
    • “There have been at least 56 injuries associated with the error, the FDA said. However, no deaths have been reported.”
  • Reuters adds,
    • “The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK’s (GSK.L)  blockbuster shingles vaccine Shingrix, providing patients a more convenient option to receive the shot, the company said on Thursday.”

From the judicial front,

  • Healthcare Dive reports,
    • “A Texas federal judge has dismissed Humana’s lawsuit against the federal government seeking to improve its Medicare Advantage star ratings, in a significant loss for the insurer.
    • “Humana sued the CMS in October 2024 to reverse its quality scores, arguing that the agency acted arbitrarily and capriciously in downgrading the ratings, which are tied to billions of dollars in reimbursement, for 2025.
    • “However, District Judge Reed O’Connor ruled on Friday that Humana failed to exhaust administrative remedies before filing its lawsuit. Humana said it is exploring further legal action.”
  • Bloomberg Law lets us know,
    • “A federal judge refused Friday to remove an order that halted US Health Secretary Robert F. Kennedy Jr. from carrying out mass firings and restructuring across health agencies. 
    • “The US District Court for the District of Rhode Island disagreed with the Justice Department’s request to lift the order due to pending stays in two other cases that challenge with government’s reduction-in-force. Those cases are McMahon v. New York , regarding layoffs at the Department of Education, and Trump v. AFGE, regarding President Donald Trump’s reorganization of the federal government.” * * *
    • “Defendants misguidedly argue that the Supreme Court’s recent grants of stays pending appeals” in those cases mean that the court should immediately reverse its July 1 decision granting plaintiffs’ preliminary injunction, Judge Melissa R. DuBose for the US District Court for the District of Rhode Island said in the order. * * *
    • “DuBose rejected the government’s request to stay pending the appeal.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many Southeast, Southern, and West Coast states. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among young children 0-4 years old. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in many Southeast, Southern, and West Coast states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP tells us,
    • “Only 35% to 40% of US pregnant women and parents of young children say they intend to fully vaccinate their child, per survey results from researchers at Emory University and the Centers for Disease Control and Prevention (CDC).
    • “For the two surveys, published as a research letter this week in JAMA Network Open, the investigators recruited 174 pregnant women and 1,765 parents from a nationally representative panel in April 2024 to answer questions about their intent to have their child receive all recommended vaccines by 18 months.
    • “Many parents in the US choose to delay or refuse vaccines that are recommended for their child from birth to age 18 months,” the study authors wrote. “Research is necessary to understand the value of intervening during pregnancy to proactively support parents with vaccination decisions before the birth of the child, as implementation of such interventions will require substantial engagement of health care professionals and entities outside of the pediatric care setting.”
  • Per an NIH news release,
    • “Sjögren’s disease is a chronic autoimmune condition affecting up to four million Americans, characterized by symptoms such as dry eyes and mouth, fatigue, and inflammation in various organs. Although it primarily affects women, men tend to face more severe complications. The disease can impact pregnancy outcomes and increase risk for lymphoma. Despite extensive research, its underlying causes remain unclear, and current treatments mainly aim to manage symptoms.
    • “Recent NIH-supported research using mouse models sheds new light on Sjögren’s disease, pointing to dysfunction in regulatory T cells and a heightened interferon gamma response as key drivers of disease symptoms. A drug called baricitinib, already approved for conditions such as rheumatoid arthritis, showed promising results in mice by reducing inflammation and restoring gland function. The similarities between mouse and human immune responses suggest that baricitinib could be a viable future treatment for people with Sjögren’s disease, offering hope for more targeted therapies ahead.”
  • The Washington Post reports,
    • “A baby’s sex may not be up to mere chance.
    • “A study published Friday in the journal Science Advances describes the odds of having a boy or girl as akin to flipping a weighted coin, unique to each family. It found evidence that an infant’s birth sex is associated with maternal age and specific genes.
    • “The findings challenge assumptions that birth sex is random. They mirror the results of similar studies in Europe that have also found that birth sex does not follow a simple 50-50 distribution.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Prescription drug denials by private insurers in the United States jumped 25 percent from 2016 to 2023, according to a new analysis of more than four billion claims, a practice that has contributed to rising public outrage about the nation’s private health insurance system.
    • “The report, compiled for The New York Times by the health analytics company Komodo Health, shows that denial rates rose from 18.3 percent to 22.9 percent. The rejections went up across many major health plans, including the country’s largest private insurer, UnitedHealthcare.” * * *
    • “The analysis found that the most common reason for a drug claim to be rejected was that a refill had been requested “too soon,” before the patient was eligible for more medication.”
    • “Appropriate prescription drug denials can happen for numerous reasons, and many can be resolved within minutes,” said Greg Lopes, a spokesman for the Pharmacy Care Management Association, a trade group for pharmacy benefit managers.”
  • Beckers Payers Issues gives us a look inside the Humana-Mercy partnership “that’s shaping the future of health care.”
  • Behavioral Health Business tells us,
    • “Lyra Health, a national provider of mental health benefits for employers, has acquired Bend Health with the goal of strengthening its pediatric and neurodiversity capabilities. 
    • “Lyra’s acquisition of Madison, Wisconsin-based Bend Health was completed July 16. Exact terms of the deal were not disclosed in the press release.
    • “The move enables Lyra to utilize Bend Health’s collaborative care model and specialized providers to offer more comprehensive evaluations and virtual intensive outpatient care to its 20 million members.”
  • NCQA, writing in LinkedIn, discusses a new look for HEDIS that will arrive on August 1.

Midweek update

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

From Washington, DC

  • The U.S. Office of Personnel Management has posted a bio of its new Director Scott Kupor.
  • USA Today reports,
    • “President Donald Trump signed a law that extends tougher prison sentences for fentanyl trafficking, surrounded by relatives of people who died from overdoses and lawmakers who approved the bill.
    • “Today we strike a righteous blow to the drug dealers, narcotic traffickers and criminal cartels,” Trump said. “We take a historic step toward justice for every family touched by the fentanyl scourge.”
    • “The law places fentanyl on the Drug Enforcement Administration’s list of most serious drugs with no accepted medical use and a high potential for abuse. The list includes drugs such as heroin, cocaine and LSD. Fentanyl has been temporarily assigned to the Schedule 1 category since 2018. The law makes the designation permanent.
    • “The law also makes permanent mandatory minimum penalties of five years in prison for trafficking 10 grams of fentanyl and 10 years for 100 grams.”
  • Per a Senate news release,
    • “Sens. Chuck Grassley (R-Iowa) and Maggie Hassan (D-N.H.) reintroduced the Healthy Moms and Babies Act to improve maternal and child health care across the nation. The maternal health crisis in the United States particularly affects those living in rural America and women of color. Grassley previously chaired the Senate Finance Committee and continues to serve as a committee member, alongside Hassan.
    • “The legislation builds on Grassley and Hassan’s longstanding efforts to improve maternal and child health by delivering high-quality coordinated care, supporting women and babies with 21st century technology and taking other steps to reduce maternal mortality.” * * *
    • “Additional information on the Grassley-Hassan Healthy Moms and Babies Act is available below:
  • STAT News informs us,
    • “Doctors for decades have been paid using rates developed largely under the advice of the industry’s main lobbying group, the American Medical Association. Experts have railed against the system for decades, calling it complex and filled with self-interested factions that ultimately favor surgeons and higher-priced specialists over primary care clinicians. 
    • “Medicare’s proposal for 2026 would create a so-called “efficiency adjustment” that would reduce payment by 2.5% for thousands of procedures and diminish some of the influence held by the AMA’s advisers, known as the Relative Value Scale Update Committee, or the RUC. 
    • “This is probably one of the most controversial components of this rule,” said Shari Erickson, a top official with the American College of Physicians, which mostly lobbies for primary care doctors. “It is sort of continuing to chip away at some of the concerns that many have raised about the RUC and the power that they’re viewed as having.”
    • “The result is that family medicine doctors and other primary care physicians would see the highest average increases in their payments, per Medicare’s estimates. Dermatologists, gastroenterologists, general surgeons, neurosurgeons, ophthalmologists, orthopedic surgeons, pathologists, and radiologists would experience some of the biggest net decreases to their Medicare pay.
    • “Importantly, the agency would exempt services that are based on time — for example, routine 15- and 30-minute visits performed by primary care physicians. More broadly, Medicare is using the savings from these cuts to bump up the “conversion factor” that dictates the payment rates for all physician services.
    • “Michael Abrams, managing partner of health care strategy firm Numerof & Associates, said this would help fix what’s been a “very serious issue” for decades: the pay imbalance between primary and specialty care.” 
  • The Government Accountability Office released a report on comparative clinical effectiveness research this week.
    • “Comparative clinical effectiveness research compares the success and outcomes of available treatment options for various diseases and conditions. Findings from this research can provide important information on more effective treatments. The Department of Health and Human Services shares these research findings with the public and helps to apply the findings in health care settings.
    • “But we found that HHS hasn’t done a thorough evaluation of these activities. Completing an evaluation will help to show if HHS’s efforts are promoting evidence-based care and, ultimately, improving health outcomes.
    • “Our recommendation [to HHS] addresses this issue.”
  • From the judicial front,
    • Fierce Healthcare lets us know,
      • “Blue Cross and Blue Shield of Kansas City has improperly reduced payments for inpatient services in coordination with third-party vendors, a lawsuit from AdventHealth Shawnee Mission Medical Center alleges.
      • “The hospital claims Blue KC uses clinical validation audits to reject medical diagnoses and declare them “invalid” under “secret and dubious criteria,” in violation of state and federal law, the lawsuit (PDF) says. Blue KC, allegedly, has not paid more than $2 million owed to the AdventHealth hospital after invalidating more than 350 medical diagnoses.
      • “At the crux of the plaintiff’s argument is Blue KC’s relationship with third-party care platforms for providers and payers. The health system has never approved of Blue KC’s relationship with vendors performing clinical validation audits, yet AI technology can supplant a physician’s opinion. Vendors used by Blue KC have publicly touted its AI technology in the past.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary. The 52 standards are for canned fruits and vegetables, dairy products, baked goods, macaroni products and other foods.
    • “Today’s actions are the first results from the agency’s ongoing analysis of its portfolio of over 250 food Standards of Identity (SOI) to make sure they are useful, relevant and serve consumers in the best possible way. The removal of these standards is in alignment with broader efforts to ensure that HHS is directing resources to where they’re most needed – delivering better outcomes for the American people.”
  • Per Fierce Pharma,
    • “The FDA is raising efficacy questions over Lundbeck and Otsuka’s proposed combination of their Rexulti with Viatris’ Zoloft as a treatment for post-traumatic stress disorder (PTSD).
    • “For an upcoming meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee, the agency is asking an expert panel to weigh in on whether results from an exploratory phase 2 trial and a positive phase 3 study can overcome negative findings from a second phase 3 of the combination.
    • “Discordant results” from the two phase 3 trials have FDA reviewers worried, especially since the agency said it was unable to identify an explanation for the differing outcomes despite “extensive exploratory analyses.”

From the public health and medical research front,

  • Health Day tells us,
    • “Folks using GLP-1 weight loss drugs like Ozempic are more likely to suffer from severe acid reflux, a new study says.
    • “People with type 2 diabetes were more likely to suffer from gastroesophageal reflux disease (GERD) if they were prescribed a GLP-1 drug compared to those taking sodium-glucose cotransporter-2 (SGLT-2) inhibitors, researchers reported today in the Annals of Internal Medicine.
    • “We estimated that most GLP-1 (drugs) increased risk for GERD,” concluded the research team led by Laurent Azoulay, an associate professor with the Jewish General Hospital’s Center for Clinical Epidemiology in Montreal, Canada.
    • “The risk for serious GERD-related complications was higher among smokers, people with obesity and folks with existing stomach problems, researchers said.
    • “Although our findings need to be corroborated in other studies, clinicians and patients should be aware of a possible adverse effect of GLP-1 (drugs) on GERD,” researchers noted.”
  • BioPharma Dive reports,
    • “In experimental, dual-acting obesity drug from Hengrui Pharma and biotechnology startup Kailera Therapeutics succeeded in a Phase 3 trial in China, positioning the companies to seek approval there and to begin global late-stage testing.
    • “The drug, a once-weekly injection dubbed HRS9531, spurred about 18% weight loss in treated participants after 48 weeks, roughly 16% more than those given a placebo. Nearly 9 in 10 people given HRS9531 lost at least 5% of their body weight and over 44% achieved at least 20% weight loss, the companies said Tuesday.
    • “Hengrui and Kailera didn’t disclose specific safety data, only noting that most treatment-emergent adverse events were mild to moderate and gastrointestinal-related. Detailed results will be presented at a future medical meeting. Hengrui will file an approval application in China, while Kailera will initiate global studies that involve higher doses and a longer treatment duration, the startup’s CEO, veteran executive Ron Renaud, said in the statement.”
  • Cardiovascular Business relates,
    • “Vitamin D supplements can help patients reduce their risk of developing cardiovascular disease (CVD), according to a new analysis in Nutrients.[1] In fact, the team behind the new study argued that prior research finding no connection between vitamin D and CVD was flawed.  
    • “The global prevalence of CVD for 2025 was estimated at 598 million, and global CVD deaths at 20.5 million,” wrote first author William B. Grant, PhD, with the Sunlight, Nutrition, and Health Research Center in San Francisco. “Thus, finding ways to reduce the risk of CVD is warranted. There has been a long-standing debate regarding the role of vitamin D in reducing the risk of CVD.”
    • “Grant et al. did note that many randomized controlled trials (RCTs) have found that vitamin supplements fail to reduce cardiovascular risks when compared to a placebo. However, the team added, several other kinds of stories have told another story—and there is a reason for this difference.
    • “RCTs are used for medications to evaluate the use of drugs to prevent and treat diseases,” they wrote. “These drugs are not found in nature, whereas vitamin D is. Additionally, pharmacological agents have narrow dose–response curves. In contrast, nutrients are threshold agents and have broader and often S-shaped dose–response curves.”
  • and
    • “A new-look polymer heart valve is associated with encouraging one-year outcomes in patients undergoing surgical mitral valve replacement (SMVR), according to new data presented at New York Valves 2025 and published in the Journal of the American College of Cardiology.[1]
    • “The Tria mitral valve from Utah-based Foldax is built using LifePolymer, a proprietary material that does not include any animal tissue. Both the frame of the valve and its leaflets are robotically generated to match the patient’s native mitral valve.
    • “The valve made headlines in early June when it was approved for commercial use in India. This represented the first time a polymer heart valve had ever gained such an approval anywhere in the world.”
  • Per a National Institutes of Health press release,
    • “A scientific team supported in part by the National Institutes of Health (NIH) has developed a new, ultra-high-resolution brain imaging system that can reconstruct microscopic brain structures that are disrupted in neurological and neuropsychiatric brain disorders. The new system is a significant advance over conventional magnetic resonance imaging (MRI) scanners that cannot visualize these tiny but clinically important structures.
    • “The system, called the Connectome 2.0 human MRI scanner, overcomes a significant hurdle for neuroscientists: being able to bridge different brain regions and probe tiny structures necessary to define the “connectome,” the complex matrix of structural connections between nodes in the nervous system, and to do it noninvasively in living humans.
    • “This research is a transformative leap in brain imaging – pushing the boundaries of what we can see and understand about the living human brain at a cellular level,” said John Ngai, Ph.D., Director of NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. “The new scanner lays essential groundwork for the BRAIN CONNECTSprogram’s ultimate goal of developing a wiring diagram for the human brain.”
    • “The scanner is innovative in two major ways: it fits snugly around the heads of living people, and it has many more channels than typical MRI systems. These advances greatly increase the signal-to-noise ratio of the system, providing much sharper images of very small biological brain structures than previously possible. These technical upgrades will enable scientists to map human brain fibers and cellular architecture down to nearly single-micron precision to study how subtle changes in cells and connections relate to cognition, behavior, and disease.”
  • Per a National Institute of Standards and Technology news release,
    • “In an effort to foster progress in cancer research, the National Institute of Standards and Technology (NIST) is releasing detailed and comprehensive data about the entire genetic content of a pancreatic cancer cell. Scientists can use it to research tumors, improve cancer diagnostic tests, and develop new cancer treatments.
    • “The NIST data on this cancer genome — that is, the full set of genetic instructions from the cell, including the mutations that caused the disease — is several terabytes in size. The genome came from a 61-year-old pancreatic cancer patient who explicitly consented to making the genetic code of her cancer cells publicly available for research and clinical use.”
  • Per STAT News,
    • “One in five individuals who receive a kidney transplant experience a rejection episode within a year. A new approach to donor-recipient matching could help change that.
    • “Mismatches between donors and recipients in SIRP-alpha, an immune cell surface receptor, could contribute to transplant rejection, researchers report in a study published Wednesday in Science Translational Medicine.
    • “What’s groundbreaking about it is that innate immune cells, immune cells that we have not necessarily associated with sensing the graft and attempting to reject it, are now in the center of the rejection battle,” said Fadi Lakkis, a study co-author and professor of nephrology at Stanford University.”
  • and
    • “Ten years ago, U.K. policymakers gave the green light to a pioneering reproductive technology meant to spare children from being born with types of rare but sometimes fatal diseases caused by genetic mutations in the powerplants of cells. The method involved combining not just the genes of a mother and father to produce an embryo, but a bit of DNA from a third person as well. 
    • “On Wednesday, the team in England that has been performing the technique reported that eight healthy babies have been born so far, highlighting that the approach reduced the risk of children inheriting disease-causing mutations in the pieces of DNA contained in our mitochondria. The results, published in a pair of papers in the New England Journal of Medicine, have been long awaited as the first large test of the approach, which is known as mitochondrial replacement therapy or mitochondrial donation. 
    • “All the children are well and continue to meet developmental milestones,” Bobby McFarland, a professor of pediatric mitochondrial medicine at Newcastle University and one of the experts behind the research, told reporters at a press conference in London Wednesday.”
  • and
    • “An oral capsule can efficiently deliver liquid mRNA therapy directly to the gut, a possible new delivery mechanism for mRNA vaccines, a new study finds.
    • “In the study published in Science Translational Medicine on Wednesday, researchers said they successfully used RNACap, a capsule engineered to prevent stomach acids from degrading liquid mRNA therapy to treat inflammatory bowel disease. Once the capsule was in the gut, they used normal stomach contractions to release the mRNA therapy.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “ChristianaCare and Virtua Health are exploring a potential merger that would yield an eight-hospital nonprofit regional health system spanning 10 New Jersey, Delaware, Pennsylvania and Maryland counties.
    • “The systems have signed a nonbinding letter of intent to explore the deal; they announced Wednesday but did not give a timeline for when the combination could be executed. The resulting entity would have almost 30,000 employees, more than 600 sites of care and over $6 billion in annual revenues.
    • “At a time of great uncertainty in health care, ChristianaCare and Virtua Health have the foresight and courage to explore what is possible,” Janice Nevin, M.D., president and CEO of ChristianaCare, said in the announcement. “We are excited to take this bold step to double down on our mission, multiply our excellence and ensure our legacy of high-quality care in our local communities for generations to come.
    • “Together, we aim to create an integrated regional health system built on human connection, clinical excellence and a deep commitment to all people in the communities we serve,” Virtua Health President and CEO Dennis Pullin said.”
  • BioPharma Dive informs us,
    • “Johnson & Johnson on Wednesday reported quarterly prescription drug sales that for the first time surpassed $15 billion, highlighting the strength of the pharmaceutical company’s portfolio during a year in which its formerly top-selling drug lost market exclusivity.
    • “Second quarter sales for J&J’s pharmaceuticals business reached $15.2 billion between April and June, nearly 4% higher than the same period last year on an operational basis. Overall second quarter sales were up 4.6% on the same basis to total $23.7 billion, beating Wall Street forecasts.
    • “J&J now expects higher operational growth for 2025, increasing the midpoint of its guidance range for both adjusted sales and earnings per share.”
  • MedTech Dive relates,
    • “Quest Diagnostics is planning to offer laboratory testing based on Fujirebio Diagnostics’ recently Food and Drug Administration-authorized Alzheimer’s disease blood test.
    • “In May, Fujirebio’s in vitro diagnostic became the first blood test to aid in the diagnosis of Alzheimer’s cleared by the FDA. Quest, which disclosed its plans for the IVD last week, launched a laboratory-developed test for similar biomarkers in April.
    • “The clinical lab plans to make Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test available for use by physicians and researchers this summer.”
  • KFF issued a report about “The Uncertain Future of “Medicare’s Stand-Alone Prescription Drug Plan Market and Why It Matters.”
    • “Ahead of Medicare’s annual mid-year announcement about the national average premium for Part D prescription drug coverage in 2026 and other plan details, two questions loom large for the insurers that sponsor Part D stand-alone prescription drug plans (PDPs) and the 23 million people in traditional Medicare who are currently enrolled in these plans: Will the Trump administration continue Medicare’s Part D premium stabilization demonstration for a second year, and what will the PDP market look like in 2026 and in subsequent years? The answer to the first question could determine whether monthly PDP premiums remain at a relatively affordable level and whether PDP availability remains stable in 2026. The answer to the second question has larger implications for the viability of traditional Medicare as an option for beneficiaries nationwide but especially for beneficiaries who live in rural areas. This is because rural Medicare beneficiaries are more likely to be enrolled in traditional Medicare and rely more on drug coverage from stand-alone PDPs than Medicare Advantage plans.”
  • The Brown & Brown consulting firm explains why employers and health plans should be paying attention to surgical centers of excellence.
  • Per Fierce Healthcare,
    • “Employers have spent several years taking steps to avoid shifting healthcare costs to workers, but as expenses continue to rise, some firms are looking to change course, a new survey shows.
    • “Analysts at Mercer polled 711 employers (PDF), including large and small firms, and found that 51% said they are either likely or very likely to shift costs to employees for their 2026 plans. That’s up from 45% who said the same for 2025, according to the survey.
    • “Of that group, 19% said they were very likely to shift costs and 33% said they were likely to do so in 2026, the survey found. For 2025, 14% of employers said very likely and 31% said likely.
    • “Employers’ healthcare costs grew 4.5% in 2024 and are expected to increase by an average of 5.8% this year, according to Mercer. That figure accounts for cost-saving measures, but costs could rise by an estimated 8% if employers take no action.”

Midweek report

David Ermer–CDC, CMS, Congress, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican leaders worked to win over GOP critics of President Trump’s sprawling domestic-policy bill (Senate amendment to H.R. 1) headed into crucial votes expected later Wednesday.
    • “Dozens of lawmakers had raised complaints about the revised “big, beautiful bill,” which passed the Senate a day earlier, with fiscal hawks wanting deeper spending reductions and moderates worried about cuts to the social safety net. 
    • “I feel very positive about the progress,” said House Speaker Mike Johnson (R., La.), who has been meeting with lawmakers all day. “I feel good about where we are and where we’re headed,” he said.” 
  • P.S. The Wall Street Journal reports Thursday morning that the bill cleared another procedural hurdle, passing H.R. Res. 566 which creates a rule for House consideration of H.R. 1. The House now can hold a final vote on the bill on Thursday.
  • Per a Senate news release,
    • “On Wednesday, July 9, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing to examine the future of health care, and how to improve cybersecurity to better protect Americans’ health privacy. This hearing will take place directly after the Committee vote on the nomination of Susan Monarez to be Director of the Centers for Disease Control and Prevention.“
  • Govexec reports,
    • Across the federal government, tens of thousands of blue-collar federal employees are still waiting on their 2025 pay raise, all because of Defense Secretary Pete Hegseth’s purge of advisory committees as the Pentagon.
    • For most federal employees, receiving their share of the (mostly) annual across-the-board pay increase is a simple process. The president issues an alternative pay plan—to avoid massive automatic increases due to the Federal Pay Comparability Act—or Congress stipulates in appropriations legislation how it would override the president, and then the Office of Personnel Management publishes new pay tables in time for the first full pay period in January.
    • Raises for blue collar federal workers, hired under the Federal Wage System, are based on an extrapolation of those pay raises along with a series of wage surveys conducted by the Department of Defense Wage Committee. The committee then votes to implement wages region by region over the course of the year.
    • But in March, Hegseth issued a memo instructing all advisory committees within the Defense Department to halt operations for a 45-day review to “ensure that the department’s advisory committee efforts align with our most pressing strategic priorities.” At the conclusion of that six-week period, Hegseth purged all the members of the Pentagon’s advisory panels and ordered the recommendation of new members within 30 days.
    • As a result, the wage committee, whose members are required by federal regulations to consist of three agency officials and two union leaders, has been unable to meet. According to data provided by the Defense Civilian Personnel Advisory Service and the American Federation of Government Employees, the panel’s shuttering has stalled pay raises for blue collar feds in 87 of the 248 local wage areas, or roughly 60,000 workers.
  • and
    • “The Office of Personnel Management has started to go down a different path than the one it started on in early May when they attempted a sole-source human resources management software contract with Workday.
    • “OPM announced its intentions to award that contract to Workday on May 2 and then cancelled it within the following week. Industry backlash ensued after the initial decision on the sole-source contract, which was set up to help OPM meet the Trump administration’s July 15 deadline for having a new HR system in place.
    • “OPM now appears to be starting on a more traditional procurement process and has scheduled an industry engagement event for July 9-10, according to a Tuesday Sam.gov notice.
    • “The government is now looking at the end of 2028 as its target date to have a new HR management system scaled across all agencies, the notice says.”
  • The American Hospital Association News tells us,
    • “The Departments of Justice and Health and Human Services today announced the creation of the DOJ-HHS False Claims Act Working Group to combat health care fraud. The group will be jointly led by the HHS General Counsel and the Deputy Assistant Attorney General of the DOJ’s Commercial Litigation Branch and include participants from the Office of Counsel to the HHS Office of Inspector General, DOJ’s Civil Division, the Centers for Medicare & Medicaid Services’ Center for Program Integrity and designees representing U.S. Attorneys’ Offices.
    • “The working group’s priority areas for enforcement include Medicare Advantage; drug, device or biologics pricing; barriers to patient access to care; kickbacks related to drugs, medical devices, durable medical equipment, and other products paid for by federal health care programs; materially defective medical devices impacting patient safety; and manipulation of electronic health records systems to drive inappropriate usage of Medicare-covered products and services. The working group is encouraging whistleblowers to identify and report violations of the FCA related to those priority enforcement areas.”
  • Healthcare Dive adds,
    • “The HHS wants to move oversight of 340B from the Health Resources and Services Administration to the CMS, a move that could prove negative for the the two-thirds of U.S. hospitals that rely 340B to fund patient services, cover uncompensated care and, in some cases, keep their doors open.
    • “The potential change is putting providers on edge. And covered entities are right to be worried, given the CMS’ bellicose history with the program, according to experts.
    • “This could be truly devastating for some of these covered entity providers,” said Sarah Bowman, a principal with public accounting firm PYA who advises hospitals and health systems on 340B compliance.
    • “But increased scrutiny of how 340B dollars are being generated and used is probably a good thing, especially amid mounting evidence of fraud and abuse in the drug discount program.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Regeneron Pharmaceuticals has won Food and Drug Administration accelerated approval of its Lynozyfic treatment for certain patients with the blood cancer multiple myeloma.
    • “Regeneron on Wednesday said the FDA green light covers Lynozyfic in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) is alerting the public about a new safety issue associated with Johnson & Johnson MedTech’s Automated Impella Controller (AIC). The device displays patient data when the company’s line of Impella heart pumps are being used to provide mechanical circulatory support. 
    • “Johnson & Johnson MedTech has received reports of the AIC not detecting the heart pumps when they are connected. If the connection fails without the user noticing immediately, the FDA said it “may result in inadequate hemodynamic support.” 
    • “Patients in cardiogenic shock are at increased risk, as prolonged episodes of inadequate support may not be well tolerated and may lead to life-threatening injuries,” the agency warned in a new advisory.
    • “The issue can occur with all versions of the Impella technology. As of June 13, three patient deaths have been linked to this connection issue. 
    • “Johnson & Johnson MedTech sent a letter to all affected customers, highlighting the importance of keeping a backup AIC on hand. The company also provided specific details about what to look for during console-to-console transfers and the start of each case.” 
  • The AHA News adds,
    • The Food and Drug Administration has issued early alerts for certain Spectrum infusion pumps from Baxter and Abiomed Automated Impella Controllers. The agency said the affected infusion pumps may have an incorrect version of software, while the Abiomed product may not detect an Impella pump when connected.
  • BioPharma Dive calls attention to five FDA decisions to watch out for in the third quarter of 2025. “The agency is set to decide by September on new therapies for Duchenne cardiomyopathy, multiple myeloma and spinal muscular atrophy.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Doctors for America, the Main Street Alliance and three cities have sued the Centers for Medicare & Medicaid Services (CMS) [in Baltimore, Maryland federal court] over a recent Affordable Care Act (ACA) final rule the agency said will help counter improper enrollments.
    • “The plaintiff cities named in the lawsuit are Baltimore, Chicago and Columbus.
    • “The groups and cities say the regulation will cause upward of 1.8 million Americans to lose coverage in 2026, leading to downstream raised premiums and out-of-pocket costs.”
  • MedTech Dive relates,
    • “A bankruptcy judge approved the sale of 23andMe to a nonprofit led by Anne Wojcicki, co-founder and former CEO of the genetic testing company. 
    • “U.S. Bankruptcy Judge Brian Walsh issued an order on June 27 approving the sale to the nonprofit TTAM Research Institute, adding that all objections to the sale are denied unless otherwise noted. In June, TTAM won a bid to buy the company for $305 million.
    • “States that have filed privacy objections, saying the sale does not comply with their state’s privacy laws, have until July 7 to be granted a stay to appeal the case, Walsh ruled.  California, Kentucky, Tennessee, Texas and Utah have said that the proposed sale would violate their genetic privacy statutes because 23andMe does not propose to seek opt-in consent from every customer in their states.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP points out,
    • “In its weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 40 more measles cases today, boosting the number of infections this year to 1,267, which is just 8 shy of passing the total in 2019, which was the highest since the disease was eliminated in the country in 2000.
    • “Though the large outbreak in West Texas has slowed substantially, the number of smaller outbreaks and travel-related cases continues to grow. The CDC this week reported 4 more outbreaks, raising the national total to 27. So far this year, 88% of confirmed cases have been linked to outbreaks. For comparison, the United States had 16 outbreaks for all of 2024.”
  • Per Health Day,
    • “The COVID-19 pandemic took a toll on Americans’ guts, researchers report.
    • “Gut disorders like irritable bowel syndrome (IBS) increased significantly during the COVID-19 pandemic, a new study says.
    • “Rates of IBS nearly doubled among U.S. adults, rising from around 6% in May 2020 to about 11% in May 2022, results show.
    • “Other gut health problems like constipation also increased, researchers report in the journal Neurogastroenterology & Motility.”
  • Per an NIH news release,
    • “Scientists at the National Institutes of Health (NIH) and their colleagues at the University of California, San Diego, have found that fine-particulate air pollution, which includes pollution from vehicles and industry, was strongly associated with increased genomic changes in lung cancer tumors among people who have never smoked. By assembling the largest-ever whole-genome analysis of lung cancer in individuals who have never smoked, researchers were able to link air pollution exposure to increased cancer-driving and cancer-promoting genetic mutations. This could potentially lead to more prevention strategies for never-smokers.
    • “Researchers analyzed lung tumors from 871 never-smoker patients across 28 geographic locations worldwide as part of the Sherlock-Lung study. They found associations between air pollution exposure and changes in the TP53 gene, and other genetic mutational signatures previously associated with tobacco smoking. They also observed a relationship between air pollution and shorter telomeres, which are sections of DNA found at the end of chromosomes. Telomeres shorten naturally with age and shorter telomeres are related to cells inability to continue to replicate. However, scientists found fine particulate air pollution was linked to premature shortening of telomeres.
    • “Prior genomic studies of lung cancer have focused on tobacco smokers, leaving a significant gap in our understanding of how lung cancer develops in people who have never used tobacco. By beginning to uncover the mechanisms through which tissues acquire cancer-causing or cancer-promoting mutations following environmental exposures, this study helps scientists better understand the primary drivers of lung cancer in this population—which represents up to 25% of all lung cancer cases globally.
    • “Interestingly, the researchers found that while exposure to secondhand smoke was associated with slightly higher mutation burdens and shorter telomeres, compared to tumors in patients who were not exposed, it did not lead to an increase in cancer-driving mutations or mutational signatures. This suggests that secondhand smoke may have a lower overall ability to cause genetic mutations, known as mutagenicity, compared to air pollution.
    • This work was led by researchers at NIH’s National Cancer Institute and the University of California, San Diego, and published in Nature on July 2, 2025.”
  • Per STAT News,
    • “An experimental psychedelic therapy from the U.K. company Beckley Psytech significantly reduced symptoms of treatment-resistant depression in a mid-stage trial, newly released data show, raising expectations for a class of drugs racing toward potential approval by U.S. regulators. 
    • “Companies like Beckley, Atai Life Sciences, and Compass Pathways — the first two are in the process of merging — are now vying to bring psychedelic therapies to market at a time when the regulatory and political climate seems to be shifting. The industry has backing from members in both parties, and several psychedelics-friendly figures have been appointed to policy roles under health secretary Robert F. Kennedy Jr.”
    • “In a Phase 2b clinical trial, Beckley’s compound, BPL-003 — an intranasal formulation of mebufotenin, a short-acting compound related to the psychedelic DMT — led to a reduction of 12.1 and 11.1 points on a standard clinical measure of depression called the MADRS scale at day 29, depending on dose. That compares to a 5.8 reduction in the low-dose comparator group, meeting the trial’s primary and key secondary endpoints. There were 193 participants in the study.
    • “This is good news for the field,” said Boris Heifets, an anesthesiologist at Stanford University who studies psychedelic drugs but is not involved with Beckley. “The market may react — people want a miracle, where a single dose is going to undo years of bad living and mood disorders and trauma. That’s unlikely. … [This] suggests moderate efficacy, sustained improvement, and safety.” 
  • BioPharma Dive discusses, “Sodium channel blockers for pain: New opportunities after Vertex’s ‘watershed’ moment. The success of Vertex’s opioid alternative Journavx could aid a group of biotechs that aim to take a similar development path with NaV1.8 and NaV1.7 inhibitors.”
    • “In January, the Food and Drug Administration approved this molecule [Nav1.8], known commercially as Journavx, as a treatment for the sharp, short-lived “acute” pain felt after an accident or surgery. Ken Harrison, a senior partner at Novo Holdings, said a core reason his firm decided to back SiteOne was that Vertex had established these drugs can be successfully studied and brought to market.
    • “While Journavx has so far proven remarkably safe and absent of addictive properties, doctors remain torn about how useful it will ultimately be for patients. At its best, the drug looks to be only as potent as a weak opioid. At least 5,800 Journavx prescriptions were written during the third week of June; millions more will need to come for it to meet Wall Street’s blockbuster forecasts.
    • “Still, TD Cowen analysts recently described the drug’s approval as a “watershed moment that could pave the way for a new era of non-opioid pain treatments.” Indeed, SiteOne and at least 10 other developers want to follow in Vertex’s footsteps with their own medicines that stopper either the “NaV1.8” sodium ion channel, as Journavx does, or a close cousin, “NaV1.7.”
  • Drug Topics adds,
    • ‘Interventions targeted at inappropriate prescribing can be implemented to safely reduce the number of medications that are prescribed to older adults in primary care settings, according to results of a review in JAMA Network Open. Investigators said future studies should evaluate interventions using standardized criteria and reports on potential harm.” * * *
    • “One intervention could include medication reviews, which can be incorporated as usual care. In one study, investigators implemented MedReviewRx, an application that analyzes a person’s medications and medical conditions to produce a report that simplifies the regimen and enhances safety. Deprescribing interventions, which consists of identifying and discontinuing drugs when the harms outweigh the benefits, is another method that can be effective.”
    • “Community pharmacists are aptly positioned to lead deprescribing efforts. Deprescribing is reliant on individual patients, so pharmacist-led deprescribing can help to reduce the number of medications in an effective way, as pharmacists are the medication experts. Future research should utilize pharmacists’ knowledge to improve health outcomes, especially for older patients and deprescribing efforts.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Value-based care platform Astrana Health acquired some of Prospect Health’s assets Tuesday for $708 million.
    • “The deal includes Prospect Health Plan, Prospect Medical Groups, management services organization Prospect Medical Systems, pharmacy RightRx and Foothill Regional Medical Center in Tustin, California. 
    • “Astrana announced in November it would acquire Prospect Health’s assets for $745 million. Astrana said the lower purchase price announced this week reflects its “commitment to disciplined capital deployment,” but the company is still confident in Prospect’s potential value, according to a Wednesday news release.”
  • Per Fierce Healthcare,
    • “Private equity investor Nordic Capital has acquired healthcare data analytics company Arcadia. Nordic will become the company’s majority owner, which marks an exit for former investor Peloton Equity.
    • “Financial details of the deal were not disclosed.
    • “Arcadia offers a healthcare data platform that integrates data from across the industry and uses artificial intelligence, advanced analytics and performance benchmarks to help insurers and healthcare organizations improve outcomes and quality and save money.” * * *
    • “Nordic Capital’s investment is a powerful endorsement of the strength of Arcadia’s platform and confidence in our ability to deliver value by improving outcomes and reducing costs,” said Michael Meucci, president and CEO of Arcadia, in a statement. “This milestone marks a new phase of growth for Arcadia, grounded in the same mission, but with even stronger backing to scale smarter, invest faster, and accelerate innovation to meet the growing demand for data-driven intelligence in healthcare.”
    • “Arcadia works with national and regional health systems and payers, along with governmental organizations, including Aetna, Highmark Blue Cross Blue Shield, Intermountain Health, Ochsner Health, and the State of California. Arcadia’s portfolio of provider, payer, government and life science customers totals nearly 200.”
  • and
    • “Cadence, a remote monitoring service provider, has stealthily created an advanced primary care business to help health systems provide better care with artificial intelligence and connected devices.
    • Reimbursement continues to decline for physicians, and primary care providers are among some of the lowest-paid providers in healthcare, according to the Assistant Secretary for Planning and Evaluation. Yet, the specialty is of immense import for identifying chronic diseases, annual wellness exams and treating mental health and substance use disorders. 
    • “The Centers for Medicare and Medicaid Services (CMS) has undertaken a variety of initiatives to enhance access to primary care, including through models at its innovation center. CMS took decisive action on the matter when it created the Advanced Primary Care Model (APCM) in November 2024, under its annual physician fee schedule (PFS). Payments for APCM went live on Jan. 1, 2025, with the aim of providing longitudinal primary care for Medicare beneficiaries.”
    • “The APCM model is an additional monthly bundled payment that promotes the ongoing relationship between primary care providers and patients. It pays for things like having 24/7 access to the provider’s team, coordinating care within a week of a hospital discharge, home visits, expanded hours and secure messaging options.”

Tuesday report

David Ermer–Congress, HSA, Medical / Rx research, NIH, Obesity, OPM, SCOTUS, SDOH, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Senate passed President Trump’s tax-and-spending bill [(HR 1)] by a 51-50 vote, with Vice president JD Vance breaking the tie.
    • The bill extends tax cuts, reduces Medicaid spending and increases funding for defense and border enforcement.
    • The House will now vote on the bill, facing internal GOP divisions over Medicaid changes and spending cuts.
  • House of Representatives will convene for legislative business at 9 am on Wednesday morning. The House Rules Committee met about the Senate amendment to HR 1 this afternoon.
  • Reuters tells us,
    • “President Donald Trump‘s administration on Tuesday reported having 2.3 million people on federal payrolls in March, almost unchanged from prior months despite the Republican’s efforts to shrink the size of government.
    • “The Office of Personnel Management, which functions as the HR department for the federal government, published figures on Tuesday on hiring and firing across thousands of government offices, with growth in some areas of government largely canceling out cuts elsewhere.
    • “Overall, the number of federal jobs – excluding postal workers and the military – was down about 23,000 from September, the last published report on overall staffing levels.
    • “To be sure, the numbers are only through March and Trump, who took office in January, has continued efforts to shrink the federal workforce. The administration has signed deals, for example, with at least 75,000 federal workers, agreeing to pay them for several months before they resign. A spokesperson at the Office of Personnel Management said hundreds of thousands of such workers will drop off federal payrolls in October.”
  • NextGov/FCW adds,
    • “The Office of Personnel Management plans to update FedScope, the government’s portal for statistics on the federal civilian workforce, it announced on Tuesday.
    • “In the coming months, OPM will launch a newly designed platform featuring interactive visuals, detailed datasets, and tools tailored to answer the most frequently asked questions about federal employment,” OPM said in a press release, previewing a fall 2025 update to the website. 
    • “A banner on the website also hints at more regular updates, saying that “beginning this fall, Federal Workforce Data will be routinely available in an easily accessible, reimagined format.”
  • Mercer conveniently summarizes the 2026 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) along with the 2024 and 2025 figures.
  • The Justice Department and the Federal Trade Commission held listening sessions yesterday and today about lowering drug prices for Americans through competition.

From the judicial front,

  • The Washington Examiner informs us,
    • “The Supreme Court on Monday [June 30] wiped away a series of lower court decisions that favored transgender litigants, sending the cases back to the appellate level for reconsideration in light of the court’s recent ruling upholding a Tennessee ban on puberty blockers and hormone therapy for minors.
    • “The 6-3 decision in United States v. Skrmetti, handed down June 18, marked a major victory for state-level efforts to restrict transgender procedures for minors. The ruling has now prompted the justices to vacate multiple decisions from lower courts in cases involving health benefits and birth certificate policies for people who identify as transgender.
    • “In an order list issued Monday morning, the high court overturned appellate rulings that previously blocked state-level bans or coverage restrictions for transgender-related care in North Carolina, West Virginia, Idaho, and Oklahoma. The move means each case must now be reheard under the legal standard articulated in the Skrmetti ruling, which found no violation of the Constitution’s equal protection clause in a ban on medical treatments for minors who identify as transgender.
    • “The high court also declined to take up a separate appeal from Kentucky, where families challenged the state’s similar law banning transgender procedures for minors.”
  • The Court also denied reviewing two Flower court decisions holding that the Tennessee law did not violate the 14th Amendment’s due process of law clause.
    • S. Ct. Case No. 23-466 L. W., ET AL. V. SKRMETTI, JONATHAN, ET AL.
    • S. Ct. 23-492 DOE, JANE, ET AL. V. KENTUCKY
  • Fierce Healthcare lets us know,
    • “Mass layoffs and reorganization of the Department of Health and Human Services (HHS) stalled out in federal court, as a Rhode Island federal judge sided with a coalition of 19 state attorneys general against subagencies Tuesday.
    • “Filed in early May, the Democratic attorneys general argued recent actions signed off upon by HHS leadership were unconstitutional and illegal, reported Fierce Biotech. The judge agreed, granting a preliminary injunction to halt the changes. The government must file a status report by July 11.
    • “The Executive Branch does not have the authority to order, organize, or implement wholesale changes to the structure and function of the agencies created by Congress,” said U.S. District Judge Melissa Dubose, concluding her decision.”
  • Yesterday was the effective date of the Iowa PBM reform law.  Also, yesterday, a group of employers lead by the Iowa Association of Business and Industry obtained a temporary restraining order against this law, Dropbox link to TRO order.  A preliminary injunction hearing is set for July 14. Here’s a link to an MSN article on this decision.

From the public health and medical research front,

  • Prime Therapeutic relates,
    • Only 8% of individuals (or 1 in 12) initiating a glucagon-like peptide-1 (GLP-1) agonist drug for obesity without diabetes continued to do so at three years, according to the latest real-world research from pharmacy solutions partner Prime Therapeutics LLC (Prime). Meanwhile, individuals who took a high-potency GLP-1 drug approved for obesity — such as semaglutide (Wegovy®), which is now more commonly used to treat the condition — had greater persistence at 14% three years after initiating therapy. 
    • While overall persistence continues to decrease among those taking high-potency GLP-1 products after three years, persistence among those taking the drugs over a one-year period improved throughout the span of the study. For those initiating GLP-1 therapy in 2021, 33% were persistent, while in the first quarter of 2024, 63% of new initiators were persistent. This increase is believed to be largely attributed to resolving GLP-1 drug shortages in 2024.  * * *
    • “In addition to persistence and adherence insights, the Year-3 study found 38% of individuals switched GLP-1 products during the three years of study. The mean age of individuals within the same cohort is 47 years old and nearly 80% identified as female. 
    • “For additional information and study design details, refer to Prime’s Year-3 abstract.”
  • Axios adds based on a Fair Health study that “Women approaching menopause drive GLP-1 boom.”
  • Medscape points out,
    • “A report comparing childhood obesity prevalence before the COVID pandemic and since the height of the pandemic shows a dramatic rise in the numbers for Black children and Black adolescents with obesity. Findings were published in the Annals of Internal Medicine.
    • “Researchers, led by Michael Liu, MD, MPhil, with the Center for Outcomes Research at Beth Israel Deaconess Medical Center in Boston, found that overall, the prevalence of obesity didn’t change significantly. Prevalence was 20.3% from January 2011 to March 2020, when COVID shutdowns began, and rose to 22.0% from August 2021 to August 2023. But after accounting for secular trends, “no overall increase in obesity prevalence was seen during the pandemic relative to the pre-pandemic period (adjusted difference, 0.52 percentage points; 95% CI, 2.3-3.3 percentage points).
    • “Pandemic-related increases in obesity prevalence were observed only in Black children and adolescents, the authors wrote, for whom rates were 22.4% in the decade before the pandemic and 35% in the 2 years after the height of COVID.”
  • Per Health Day,
    • “Regular exercise can ease mood disorders in children and teens, offering an alternative to medications like antidepressants, a new evidence review has concluded.
    • “Both anxiety and depression decrease when kids take part in structured exercise programs, researchers reported June 26 in Journal of the American Academy of Child & Adolescent Psychiatry.
    • “Further, the review found that anxiety and depression symptoms are relieved by different types of workout regimens.
    • “Exercise is a low-cost, widely accessible strategy that could make a real difference to children’s mental health,” lead investigator Ben Singh, a research fellow with the University of South Australia, said in a news release.
    • “Importantly, exercise could help improve kids’ moods without resorting to drugs like antidepressants, researchers added.”
  • Per Infectious Diseases Advisor,
    • “Adults aged 50 to 64 years and younger adults with chronic conditions are at increased risk for influenza-associated hospitalization and death, but this risk could be mitigated through the use of recombinant influenza vaccines (RIV). These results were published in Clinical Infectious Diseases.”
  • Healio reports,
    • “Nearly three-quarters of infants were immunized against respiratory syncytial virus through maternal vaccination or nirsevimab during the first season those products were available, according to data from 10 U.S. health systems.
    • “The overall immunization coverage for infants across these health systems was higher than expected based on the limited data available from single state studies and surveys,” Stephanie A. Irving, MHS, research associate at the Kaiser Permanente Center for Health Research in Portland, Oregon, told Healio.”
  • MedPage Today notes,
    • “In a European study, higher consumption of fruits, vegetables, legumes, and potatoes was associated with a reduced risk of Crohn’s disease.
    • “High potato consumption, meanwhile, was tied to an increased risk of ulcerative colitis.
    • “The study findings may be especially relevant for children and other first-degree relatives of people with inflammatory bowel disease, researcher says.”
  • and
    • “More than half of 95 centenarians had a low amyloid load and 9% had no amyloid, autopsy data showed.
    • “A third of centenarians had a high amyloid load comparable to Alzheimer’s disease.
    • “Five centenarians maintained high cognitive performance despite a high amyloid load.”
  • NIH Research Matters covers the following topics this week: “Home test kits for cervical cancer | Education and mortality trends | Exercise and Alzheimer’s disease.”
  • CIGNA writes in LinkedIn about why it matters to close the women’s health gap in our country.
  • MedTech Dive reports on the scientific sessions at the American Diabetes Association’s conference held last month.

From the U.S. healthcare business front,

  • STAT News reports,
    • “Centene has withdrawn its financial guidance for the rest of the year after receiving data that showed its health insurance members in Affordable Care Act plans are getting a lot more care than the company had anticipated.
    • “The company is also seeing a “step-up” in medical costs among its Medicaid enrollees. Centene’s stock plummeted 23% in after-hours trading Tuesday.”
    • “The surprise disclosure may be just the beginning of problems for Centene and other insurers that rely heavily on government health care enrollees. Centene gets a majority of its revenue from ACA and Medicaid plans. Despite Centene’s pleas to Republicans not to cut the taxpayer-funded programs, Republicans are advancing a bill that would result in the largest cut ever to Medicaid.” 
  • Healthcare Dive calls attention to “six ways employers can lower healthcare costs in 2025. ‘Employers have absorbed the majority of cost increases over the past four years, and they likely cannot continue to do so,’ one expert said” and provides an updated guide to top healthcare conferences in the second half of 2025.
  • MedCity News discusses “Innovative Strategies to Enhance Financial Predictability for Self-Funded Employers. Too often, the very systems meant to provide flexibility and control are undermined by delayed reimbursements, fragmented data, and a lack of transparency across the ecosystem. Solving this isn’t about tweaking the status quo, it requires a full redesign.”
  • Modern Healthcare tells us,
    • Ascension Health has sold four Michigan hospitals to Beacon Health System. 
    • The transaction closed Tuesday and includes four hospitals — Borgess Hospital in Kalamazoo, Borgess Allegan in Allegan, Borgess-Lee in Dowagiac and Borgess-Pipp in Plainwell — plus 35 outpatient clinics and an ambulatory surgery center, according to a Tuesday news release from Beacon. Beacon is rebranding the Ascension Southwest Michigan hospitals to Beacon Kalamazoo, Beacon Allegan, Beacon Dowagiac and Beacon Plainwell.
    • “The deal was announced in April. It brings more than 2,700 employees, including 259 providers, into the Beacon system, according to the release.
    • “South Bend, Indiana-based Beacon operates 11 hospitals, including the Ascension facilities, across northern Indiana and southwest Michigan. 
    • “Financial details of the deal were not disclosed.”
  • Per the American Journal of Managed Care,
    • “Prolonged ED stays and boarding times for older adults increased from 2017 to 2024, with academic hospitals experiencing the largest rise.
    • “The Age-Friendly Hospital Measure, effective 2025, aims to limit ED stays to under 8 hours and admissions within 3 hours.
    • “Epic Cosmos data analysis showed a significant increase in prolonged stays and boarding times, especially during the COVID-19 pandemic.
    • ‘Researchers suggest patient complexity, demand, and staffing shortages as potential drivers of increased ED stays and boarding times.”
  • Beckers Hospital Review lets us know “Physician compensation grew 4.9% in the last year, with a significant uptick for primary care physicians and specialists, according to the “AMGA 2025 Medical Group Compensation and Productivity Survey.”

Monday report

David Ermer–CMS, Congress, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC.

  • The Wall Street Journal reports,
    • “Senate Republicans trudged through a marathon session Monday, aiming to pass the party’s “big, beautiful bill” and move the legislation one step further toward President Trump’s desk ahead of lawmakers’ self-imposed July 4 deadline.
    • “Voting on amendments and procedural motions started midmorning and dragged through the day as Republican leaders worked to find a balance of policies that could pass both the Senate and later the House. Trump spoke with congressional leaders by phone, and the White House said it was confident that the bill was on track even as its fate and final content remained uncertain.” * * *
    • “A final Senate vote could come late Monday or early Tuesday. If it passes, the measure would then move back to the House, where Republicans have a 220-212 majority. Moderate House Republicans argue that the Senate cut Medicaid too deeply. Others warn that the Senate is violating the House’s target that keeps tax cuts at most $2.5 trillion larger than spending cuts.” 
  • Modern Healthcare reports,
    • “Home health companies stand to lose more than $1 billion in Medicare payments under a proposed rule the Centers for Medicare and Medicaid Services published Monday.
    • “The proposed changes would represent a decrease of 6.4%, or $1.14 billion, in Medicare payments to home health agencies in 2026 compared with 2025, CMS said in a fact sheet.
    • “The proposed home health prospective payment system update includes a 2.4%, or $425 million, increase, which is offset by a 3.7%, or $655 million, decrease reflecting a proposed behavior adjustment required by statute. It also includes a 4.6%, or $815 million, decrease that reflects a proposed temporary adjustment and an estimated 0.5%, or $90 million, decrease based on a proposed update to the fixed dollar loss ratio.”
  • Per a CMS announcement,
    • “On June 30, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2026. This proposed rule would also update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2026 and proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2026, CMS is proposing to increase the ESRD PPS base rate to $281.06, which CMS expects would increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 1.9%. The CY 2026 ESRD PPS proposed rule also includes a proposed payment adjustment for certain non-labor costs for ESRD facilities located in Alaska, Hawaii, and the United States (U.S.) Pacific Territories. 
    • “CMS is proposing shortening the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey to 39 questions, removing 23 questions, and eliminating three health equity reporting measures from the ESRD QIP. Additionally, CMS is seeking input on health IT use in dialysis facilities; and input on future measure concepts. CMS also is proposing the early termination of the ESRD Treatment Choices Model.”
  • The public comment deadline for both rules is sixty days after publication in the Federal Register.
  • Per another CMS announcement,
    • “The Justice Department today announced the results of its 2025 National Health Care Fraud Takedown, which resulted in criminal charges against 324 defendants, including 96 doctors, nurse practitioners, pharmacists, and other licensed medical professionals, in 50 federal districts and 12 State Attorneys General’s Offices across the United States, for their alleged participation in various health care fraud schemes involving over $14.6 billion in intended loss. The Takedown involved federal and state law enforcement agencies across the country and represents an unprecedented effort to combat health care fraud schemes that exploit patients and taxpayers.
    • “Demonstrating the significant return on investment that results from health care fraud enforcement efforts, the government seized over $245 million in cash, luxury vehicles, cryptocurrency, and other assets as part of the coordinated enforcement efforts. As part of the whole-of-government approach to combating health care fraud announced today, the Centers for Medicare and Medicaid Services (CMS) also announced that it successfully prevented over $4 billion from being paid in response to false and fraudulent claims and that it suspended or revoked the billing privileges of 205 providers in the months leading up to the Takedown. Civil charges against 20 defendants for $14.2 million in alleged fraud, as well as civil settlements with 106 defendants totaling $34.3 million, were also announced as part of the Takedown.
    • “Today’s Takedown was led and coordinated by the Health Care Fraud Unit of the Department of Justice Criminal Division’s Fraud Section and its core partners from U.S. Attorneys’ Offices, the Department of Health and Human Services Office of Inspector General (HHS-OIG), the Federal Bureau of Investigation (FBI), and the Drug Enforcement Administration (DEA). The cases were investigated by agents from HHS-OIG, FBI, DEA, and other federal and state law enforcement agencies. The cases are being prosecuted by Health Care Fraud Strike Force teams from the Criminal Division’s Fraud Section, 50 U.S. Attorneys’ Offices nationwide, and 12 State Attorneys General Offices.”
  • The Washington Post shares some details about the Takedown.
  • The GAO issued a report today titled “Highlights of a Forum: Reducing Spending and Enhancing Value in the U.S. Health Care System.”
    • “Health care spending per capita is higher in the U.S. than in any other high-income country. Yet, people living in the U.S. don’t live as long in comparison and are more likely to die of conditions that can be prevented or treated.
    • “To find ways to help address this disparity, we convened a forum in October 2024. Experts from government, academia, and industry identified changes to the health care system that could lower costs and improve patients’ outcomes. These include improving primary care, expanding the health care workforce, and reforming health care pricing and payments.”

From the judicial front,

  • The Supreme Court accepted the Solicitor General’s recommendation by declining to review a U.S. Court of Appeals for the 10th Circuit pro-ERISA preemption opinion captioned PCMA v Mulready (S. Ct. No 23-1213). What’s good for ERISA preemption is good for FEHB preemption.

From the public health and medical research front,

  • Health Day reports,
    • “A person’s body fat percentage provides a better estimate of their risk for early death than their body mass index (BMI), a new study says.
    • “People with a high body-fat percentage were 78% more likely to die within 15 years from any cause and 3.6 times more likely to die from heart disease, researchers reported June 24 in the Annals of Family Medicine.
    • “On the other hand, BMI — an estimate of body fat based on height and weight — was not associated with a statistically significant higher risk of death from any cause, researchers found.
    • “Waist circumference also proved to be more accurate than BMI in assessing the risks posed by excess weight, researchers added.
    • “This is a game changer for body composition assessment,” lead researcher Arch Mainous III, a professor of health services, management and policy at the University of Florida, said in a news release.”
  • The American Medical Association lets us know what doctors wish patients knew about cosmetic dermatology.
  • Endocrinology Advisor tells us, “Compared with self-monitoring, continuous glucose monitoring did not improve obstetric or neonatal outcomes among women with gestational diabetes.”
  • Per Medscape,
    • The American College of Gastroenterology (ACG) has issued updated guidance on the management of Crohn’s disease (CD) that reflects the surge in development of therapeutic options available since 2018, when the last guideline was published.
    • These newer treatment options include interleukin-23 (IL-23) blockers risankizumab, mirikizumab, and guselkumab; the anti-IL-12/23 agent ustekinumab; the Janus kinase inhibitor upadacitinib; and the anti-integrin vedolizumab.
    • The intent of the guideline is to suggest “preferable approaches” to CD management established through “interpretation and collation of scientifically valid research, derived from extensive review of published literature,” said the writing group, led by Gary Lichtenstein, MD, director, Inflammatory Bowel Disease Center, Hospital of the University of Pennsylvania, Philadelphia.
  • Per a National Institutes of Health press release,
    • “Scientists at the National Institutes of Health (NIH) have found that two common types of hormone therapy may alter breast cancer risk in women before age 55. Researchers discovered that women treated with unopposed estrogen hormone therapy (E-HT) were less likely to develop the disease than those who did not use hormone therapy. They also found that women treated with estrogen plus progestin hormone therapy (EP-HT) were more likely to develop breast cancer than women who did not use hormone therapy. Together, these results could help to guide clinical recommendations for hormone therapy use among younger women.
    • “The two hormone therapies analyzed in the study are often used to manage symptoms related to menopause or following hysterectomy (removal of uterus) or oophorectomy (removal of one or both ovaries). Unopposed estrogen therapy is recommended only for women who have had a hysterectomy because of its known association with uterine cancer risk.
    • “Hormone therapy can greatly improve the quality of life for women experiencing severe menopausal symptoms or those who have had surgeries that affect their hormone levels,” said lead author Katie O’Brien, Ph.D., of NIH’s National Institute of Environmental Health Sciences (NIEHS). “Our study provides greater understanding of the risks associated with different types of hormone therapy, which we hope will help patients and their doctors develop more informed treatment plans.”
  • The Wall Street Journal reports,
    • “Moderna said Monday its seasonal influenza vaccine candidate, mRNA-1010, showed superior efficacy in a Phase 3 study that compared it with a licensed standard-dose seasonal flu vaccine in adults aged 50 years and older.
    • “MRNA-1010 achieved the most stringent superiority criterion prespecified in the study protocol, with a relative vaccine efficacy of 26.6% in the overall study population, Moderna said.
    • “Subgroup analyses confirmed a consistently strong relative vaccine efficacy point estimate across age groups, risk factors and previous influenza vaccination status, it said. In participants aged 65 years and older, mRNA-1010 demonstrated a relative vaccine efficacy of 27.4%.
    • “The severity of this past flu season underscores the need for more effective vaccines,” Moderna Chief Executive Stephane Bancel said.”
  • BioPharma Dive points out the top 10 clinical trials to watch in the second half of 2025.
    • “Expected readouts in obesity, lung cancer and atopic dermatitis headline a series of study results that could give the biotechnology sector a boost in another down year.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “Clear answers to questions are the top driver of members’ experience with their insurers, according to a report from Forrester. 
    • “The research firm scored insurers on the brand experience index, which measures customers’ and noncustomers’ brand perception, and customer experience index, which rates customer service and loyalty. 
    • “The health insurance industry had the lowest overall consumer ratings of the 10 industries studied by Forrester. 
    • “Based on consumer responses, Forrester rated answering questions with clear answers as the top driver of customer experience. Across the industry, 60% of consumers said their insurer answered questions clearly. CareFirst BlueCross BlueShield, the industry leader in this category, scored 71%. 
      • “Here are the five other key drivers of total experience for insurers, and insurers’ average scores, according to Forrester:
      • “Keeps personal and financial information secure: 54% 
      • “Helps manage care: 53% 
      • “Offers needed healthcare plans and services: 59% 
      • “Resolves problems on the first call: 56% 
      • “Has a website that meets customers’ needs: 58%” 
  • Modern Healthcare reports,
    • “OptumRx is removing prior authorization mandates for more drugs. 
    • “So far this year, the pharmacy benefit manager has eliminated reauthorizations for 140 medications patients use to treat chronic conditions, the UnitedHealth Group subsidiary said in a news release Monday. Insurance companies and PBMs require patients and clinicians to obtain reauthorizations for some drugs in cases of long-term safety concerns or potential dosing changes. Beginning Tuesday, OptumRx will cut prior authorizations for another 60 medications that treat seven chronic conditions, including HIV, high cholesterol, hypertension and and others. 
    • “Eliminating reauthorization requirements for established and effective treatments underscores our commitment to make these needed drugs more accessible, which also supports better health outcomes,” Dr. Sumit Dutta, chief medical officer, said in the release.”
  • OptumRx, writing in LinkedIn, discusses taking action against drug price hikes.
  • Healthcare IT News notes, “Taking a patient history upfront via telemedicine has been very fruitful for the high-demand specialty provider [the Kennedy-Krieger Institute]. By combining history via virtual care with a then more limited in-person visit, care can be delivered more efficiently to more patients.”
  • Per Beckers Hospital Review,
    • “Nearly 800 rural U.S. hospitals are at risk of closure due to financial problems, with about 40% of those hospitals at immediate risk of closure.
    • “The count is drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through June 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure. * * *
    • [The article] includes a state-by-state listing of the number of rural hospitals at risk of closure in the next six to seven years and at immediate risk of closure over the next two to three years. 
  • BioPharma Dive reports,
    • “Abbvie has agreed to acquire cell therapy developer Capstan Therapeutics in a deal worth up to $2.1 billion, the companies announced Monday. 
    • “The acquisition will hand AbbVie access to technology developed by Capstan that uses small fatty spheres known as lipid nanoparticles to deliver into the body genetic instructions able to engineer specific cells. It’s an ambitious scientific approach that blends the science behind CAR-T cell therapy with that of messenger RNA vaccines.
    • “Capstan is a few weeks removed from dosing the first patient in a Phase 1 trial of its lead drug candidate, which it’s testing as treatment for B cell-mediated autoimmune diseases. Dubbed CPTX2309, the therapy is designed to reprogram immune T cells to target a protein called CD19 that’s commonly found on B cells.”