Friday report

OPM

Friday report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Bloomberg Law notes,
    • Gender-affirming care will no longer be covered for federal workers in 2026, according to a letter the Trump administration sent to insurance carriers. * * *
    • The announcement, dated Aug. 15, cements the administration’s expected move to halt gender-affirming care following President Donald Trump’s January executive order to enforce laws based on a person’s biological sex. The exclusion likely tees up legal challenges under Title VII of the 1964 Civil Rights Act and Section 1557 of the Affordable Care Act, both of which contain anti-discrimination protections.
    • “This discriminatory policy denying medical care to government employees and their dependents is not only cruel—it is illegal,” Omar Gonzalez-Pagan, Lambda Legal counsel and health-care strategist, said in a statement. “The federal government cannot simply strip away essential healthcare coverage from transgender employees while providing comprehensive medical care to all other federal workers.”
  • The American Hospital Association News points out,
    • “A JAMA study published Aug. 18 found that plan design changes by Medicare Part D insurers, particularly for Medicare Advantage plans, following passage of the Inflation Reduction Act of 2022 could lead to higher cost sharing for some beneficiaries who do not reach the $2,000 out-of-pocket maximum for prescription drug coverage in 2025. Researchers said policies prevented premium increases in 2025, but Part D plans may have responded by increasing deductibles or medication cost sharing. The study found mean deductibles for MA plans decreased from $153 in 2019 to $66 in 2024, before sharply increasing to $228 for 2025. Additionally, the proportion of MA beneficiaries with coinsurance for preferred brand-name drugs ranged from 0.8% to 2.5% from 2019 to 2024, before increasing to 27.7% in 2025.”
  • BioPharma Dive tells us,
    • “A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this month. But nestled within leaked documents is a strategy that reveals more about health leaders’ goals, including potential new oversight of pharma’s direct-to-consumer advertising practices.
    • “DTC advertising has long been a target of Health and Human Services Secretary and MAHA leader Robert F. Kennedy Jr. While Congress has taken some interest in passing a ban on those ads, real reform hasn’t gained momentum.” * * *
    • “Listed under “policy reforms” within the draft, the focus on DTC advertising states that the FDA, HHS, the Federal Trade Commission and Department of Justice would “increase oversight and enforcement” under current laws for DTC prescription drug advertising violations. Instead of focusing on all media platforms, the agencies will “prioritize the most egregious violations,” such as those by social media influencers and telehealth companies.”
  • AP reports,
    • “When the Food and Drug Administration needs outside guidance, it normally turns to a trusted source: a large roster of expert advisers who are carefully vetted for their independence, credentials and judgment.
    • “But increasingly, the agency isn’t calling them.
    • “Instead, FDA Commissioner Marty Makary has launched a series of ad hoc “expert panels” to discuss antidepressants, menopause drugs and other topics with physicians and researchers who often have contrarian views and financial interests in the subjects.”

From the judicial front,

  • Beckers Payer Issues informs us,
    • “A federal judge has approved a $2.8 billion settlement resolving antitrust claims brought by healthcare providers against the Blue Cross Blue Shield Association and its independent entities, ending more than a decade of litigation.
    • “The settlement was approved Aug. 19 and covers a class of millions of hospitals, physician practices, and other providers nationwide who accused the Blues of conspiring to divide up markets to avoid competing with one another, which allegedly drove up costs and reduced reimbursements.
    • “Under the agreement, about $1.78 billion will be distributed to healthcare facilities, while $152 million is earmarked for medical professionals. The settlement also implements structural reforms valued at more than $17 billion, including how BCBS plans process claims, and how they communicate, contract with, and make payments to providers. The settlement applies to providers who treated BCBS members between July 2008 and October 2024.”
  • Per Healthcare Dive,
    • “A federal judge has vacated a Biden-era rule that would have curbed Medicare Advantage plans’ payouts to agents and brokers.
    • “On Monday, Judge Reed O’Connor of the Texas Northern District Court ruled that the CMS overstepped its authority in trying to cap payments to MA sales organizations beyond direct compensation, and in prohibiting contracts that incentivize brokers to steer seniors to specific plans.
    • “CMS may only regulate how compensation is used, not engage in ratemaking,” O’Connor wrote in his decision. It’s a loss for smaller plans, which argue that the status quo benefits larger and wealthier insurers, and a setback for efforts to curb predatory marketing in the privatized Medicare program.”
  • and
    • “Elevance has lost a legal bid to improve its Medicare Advantage quality ratings for 2025.
    • “On Monday, a Texas federal judge threw out the insurer’s suit and offered a biting indictment of Elevance’s legal argument, saying it relied on distorted math.
    • “The lower star ratings will cost Elevance at least $375 million in bonus payments and rebates.”
  • Per a U.S. Justice Department news release,
    • “Troy Health, Inc. (Troy), a North Carolina-based provider of Medicare Advantage, Medicare Part D, and Dual Eligible Special Needs Plans, has entered into a non-prosecution agreement with the Department of Justice to resolve a criminal investigation into a health care fraud and identity theft scheme involving the use of artificial intelligence and automation software to illegally obtain Medicare beneficiary information and fraudulently enroll beneficiaries into its Medicare Advantage plans.
    • “Troy told low-income Medicare beneficiaries that it would use new technologies, including its proprietary artificial intelligence platform, to improve patient health outcomes,” said Acting Assistant Attorney General Matthew Galeotti of the Justice Department’s Criminal Division. “Instead, the company misused patient data to enroll beneficiaries in its Medicare Advantage plan without their consent. Today’s resolution reflects the Criminal Division’s emerging focus on corporate enforcement in the health care space and holding both individuals and companies accountable when they defraud our medical system to enrich themselves at the expense of the American taxpayer.”
  • Per a news release from the U.S. Attorney for the Northern District of California,
    • “American Psychiatric Centers, Inc., doing business under the name Comprehensive Psychiatric Services (CPS), has agreed to pay $2.75 million to resolve allegations that CPS violated the False Claims Act by submitting false claims to government healthcare payors for certain psychotherapy services.
    • “CPS, which is headquartered in Walnut Creek, Calif., provides behavioral medicine services for individuals and families in the State of California.  Since at least 2015, CPS and its healthcare providers have submitted claims to government payors using Current Procedural Terminology codes 90833 and 90836, which are “add-on” codes to be used when psychotherapy services are performed in conjunction with an evaluation and management visit, and which require specific documentation.
    • “The settlement announced today resolves the government’s allegations that, from Jan. 1, 2015, through Dec. 31, 2022, CPS submitted fraudulent claims using these add-on codes in instances where its healthcare providers either had not provided the services described by those codes or had failed to sufficiently document that such services had been provided.  CPS will pay $2,615,569.32 to the United States and $134,430.68 to the State of California. * * *
    • “False claims increase costs and undermine the integrity of our federal health care programs, including the Federal Employees Health Benefits Program,” said Derek M. Holt, Special Agent in Charge, the U.S. Office of Personnel Management Office of the Inspector General (OPM OIG). “We support the work of our law enforcement partners and colleagues to investigate fraudulent medical billing that wastes taxpayer dollars.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 19, 2025, a total of 1,375 confirmed measles cases were reported by 42 jurisdictions: Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York City, New York State, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.
    • “There have been 35 outbreaks reported in 2025, and 87% of confirmed cases (1,190 of 1,375) are outbreak-associated. For comparison, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.”
  • Per Medscape,
    • “The experimental drug obicetrapib, a potent oral cholesteryl ester transfer protein (CETP) inhibitor, significantly slowed Alzheimer’s disease (AD) biomarker progression over 12 months in patients with cardiovascular disease, new research showed.
    • “Results revealed the drug led to a 20% improvement in levels of phosphorylated tau 217 (p-tau217) — an important indicator of AD pathology — in patients carrying the apolipoprotein E (APOE4) allele. About 65% of people with AD are APOE4 carriers.
    • “The treatment was already shown to reduce LDL cholesterol and increase HDL cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
    • “It’s encouraging to have a drug that treats cardiovascular disease and treats or prevents AD, study investigator Philip Scheltens, MD, PhD, professor of neurology and founder of the Alzheimer’s Center, Amsterdam University Medical Center, Amsterdam, the Netherlands, told Medscape Medical News.“
  • Per the University of Minnesota’s CIDRAP,
    • “Non-White US Lyme disease patients with Medicaid or Medicare coverage were more likely than their White peers to be female, hospitalized at diagnosis, diagnosed outside of primary care and the summer months, and to have disseminated disease (more widespread in the body), per a new study by Pfizer scientists co-developing a vaccine against the tick-borne infection with Valneva.
    • “From 2016 to 2021, the researchers analyzed claims-based data from 15 Lyme-prevalent states and Washington, DC, on Medicaid beneficiaries 18 years and younger and 19 and older and Medicare fee-for-service beneficiaries younger than 65 and 65 and older. 
    • “The findings were published Monday in Emerging Infectious Diseases.”
  • Medscape also calls attention to five things to know about cervical cancer.
  • Per the AHA News,
    • “B. Braun Medical has voluntarily recalled two lots of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL IV fluids due to particles inside the container, according to the Food and Drug Administration. The company said there have been no reports of serious injury, death or other adverse events associated with the issue. B. Braun said affected products should be returned to the company and not be destroyed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance companies are looking to cut costs by ranking providers like they tier pharmaceuticals.
    • “Last week, HealthPartners announced plans to offer large employers its Simplica NextGen Copay, a plan that sets fixed copays by provider and eliminates coinsurance and deductibles. CVS Health subsidiary Aetna is rolling out Aetna Informed Choice, a new plan for employers based on its variable copay plan, a spokesperson said in an email. In February, Blue Cross and Blue Shield of Minnesota launched a new investment arm focused on developing tools for its variable copay plan, Coupe Health.
    • “There’s been a resurgence in them,” said Katherine Hempstead, senior policy officer at the Robert Wood Johnson Foundation, a healthcare research philanthropy. 
    • “Variable copay plans are part of the tide of alternative health plans that have emerged in recent years, promising to help employers save costs without shifting more of the expenses to employees by raising deductibles. Like high-deductible plans, variable copay plans operate on the assumption that giving consumers “skin in the game” will drive them to select the most cost-effective service. High-deductible plans often raise costs for patients and insurers because high upfront costs drive patients to forego preventive care or drugs needed to manage their condition, worsening their health, according to a 2018 study by the University of Southern California Leonard D. Schaeffer Center Institute for Public Policy and Government Service. 
    • “The variable copay plans are constructed similarly to a tiered provider network, a long-standing health insurance benefits design that gives members the option of seeing the full array of providers but lowers cost-sharing if enrollees choose the preferred clinicians. 
    • “These are not new and not shiny,” said Sabrina Corlette, co-director of the Georgetown University Center on Health Insurance Reforms.”
  • Per Beckers Hospital Review,
    • Rochester, Minn.-based Mayo Clinic recorded an income from current activities of $380 million (7.1% margin) in the second quarter of 2025 quarter, down from $449 million (8.9% margin) during the same period last year, according to its Aug. 18 financial report. 
    • Total operating revenue was $5.3 billion for the three months ended June 30, up from $5 billion during the same period last year. Mayo’s net patient service revenue was $4.5 billion, an 8.6% increase year over year. The system attributed the growth to strong outpatient, surgical and hospital volumes, as well as increased service demand. 
  • and
    • “Somerville, Mass.-based Mass General Brigham recorded an operating income of $74.4 million (1.3% operating margin) in the third quarter of 2025, up from $47.2 million (0.9% margin) during the same period last year, according to its Aug. 15 financial report. 
    • “The system reported total operating revenue of $5.8 billion for the three months ended June 30, a 12% increase year over year. Patient care revenue totaled $3.7 billion, an 8% increase year over year. The system said this reflected a 3% increase in acute care discharges. Premium revenue increased 19% year over year to $671 million.”
  • Modern Healthcare adds,
    • Hospital costs are growing as an increasing number of sicker patients visit the emergency department, according to a new report.
    • “The average cost of an inpatient stay rose 4.8% from mid-2023 to early 2025, according to the latest national data from Sg2, a data analytics company owned by group purchasing organization Vizient. At academic medical centers, per-case cost growth nearly doubled the rate of expense inflation at community hospitals between the first quarters of 2022 and 2025.
    • “Most people arriving at emergency departments require immediate attention, which may help explain why treatment costs are increasing. Hospitals are having a tough time keeping up with demand for care as the population ages, leading to overcrowded ERs and full inpatient units. 
    • “Providers are expected to get even busier over the next 10 years, potentially creating more care backlogs, according to the report.” 
  • Beckers Hospital Review also shares RN median hourly rates by state.
    • “Median hourly base pay for registered nurses varies across states, with RNs in California earning the most, according to SullivanCotter’s “2025 Health Care Staff Compensation Survey Report.”
    • “The survey, released in July, covers nearly 2.5 million healthcare employees across over 2,660 participating organizations, including more than 800,000 individual RNs, licensed practical nurses and nursing managers.”
  • MedTech Dive offers an interview with Josep Solà, the CEO of Aktiia, whose company received In July, FDA authoriz[ation for] the first over-the-counter cuffless blood pressure monitor.
  • and tells us
    • “Venture capital investment in medtech surged at the start of 2025, prompting PitchBook to forecast a strong year ahead for funding in the sector after several sluggish years.
    • “The market data research firm counted 11 rounds worth at least $100 million each, and $4.1 billion in total venture capital funding in the first quarter alone. Brain implant startup Neuralink’s $650 million Series E financing, announced in June, was a standout as momentum continued in the second quarter.
    • “In a steady stream of private financings this summer, heart devices have been a focus. In July, Kardium announced it raised $250 million as it prepares to launch its pulsed field ablation system for atrial fibrillation, and Field Medical brought in another $35 million to study PFA in ventricular tachycardia.”
  • Beckers Hospital Review relates,
    • “Walgreens Specialty Pharmacy, which earned $25.9 billion last year from U.S. prescription revenue, has expanded its limited distribution drug portfolio to 265 medications, the company said Aug. 19. 
    • “Limited distribution drugs are specialty medications that have complex regimens, high costs and/or special handling requirements. Therapies for chronic diseases and cancers are typically administered at specialty pharmacies. These medications account for about 75% of drugs in development, according to Walgreens. 
    • “The company’s specialty pharmacy added leukemia drug Imkeldi (imatinib), HIV preventive Yeztugo (lenacapavir) and chronic skin condition treatment Imkeldi (imatinib) to its network.” 

Monday Report

David Ermer–Congress, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Huffington Post discusses OPM’s August 15, 2025, second addendum to its 2026 call letter for FEHB and PSHB benefit and rate proposals.
  • Bloomberg Law reports,
    • “Drugmakers are responding to President Donald Trump’s call to launch direct-to-consumer sales, sparking questions about how the strategy could upend the industry’s traditional players—or help preserve the status quo.
    • “Trump’s push for drugmakers to offer direct sales at the lowest price offered in other developed nations is stoking a burgeoning tactic by drugmakers aimed at ending rebates they pay to pharmacy benefit managers and health plans. But the strategy’s potential to lower patients’ costs is still unclear.
    • “Manufacturers are building a variety of direct-to-consumer pipelines that can either use patients’ insurance plans or bypass them in favor of cash payments. Industry observers say the range of options makes it hard to predict what the ultimate impact on insurers, pharmacy benefit managers, pharmacies, and wholesalers will be, and whether the new world benefits drugmakers more than consumers.
    • “It looks like they’re offering reduced prices, when, in fact, those prices are still unaffordable for people,” said Anna Kaltenboeck, president of Verdant Research and a former adviser to the Senate Finance Committee under ranking member Ron Wyden (D-Ore.).
    • “If drugmakers were serious about lowering costs for consumers, Kaltenboeck said, they could simply lower their prices across the board.
    • “This is yet another iteration of trying to avoid the conversation that we need to have about the way in which pharma companies set list prices in the United States,” she said.”
  • Reginfo.gov remains under maintenance at 6 pm ET today. P.S. At 8 am ET on Tuesday, reginfo.gov is back online but it’s displaying the Fall 2024 semi-annual regulatory agenda. So, there is more work to be done.
  • Per an HHS press release,
    • The U.S. Department of Health and Human Services (HHS) today launched MAHA in Action—a dynamic new platform showcasing the powerful federal initiatives and state-led reforms advancing President Donald J. Trump and Secretary Robert F. Kennedy, Jr.’s Make America Healthy Again (MAHA) agenda.
    • This interactive tool offers a clear, accessible window into the bold actions reshaping America’s food, health, and public safety systems. MAHA in Action is more than a tracker—it’s a public declaration of the profound changes already underway.
    • “Make America Healthy Again isn’t just a slogan—it’s a mission statement, and we’re delivering results, fast,” HHS Secretary Kennedy said. “The MAHA in Action tracker puts the wins on the map. It gives the public, the press, and policymakers real-time visibility into how we’re restoring health, integrity, and accountability to every corner of our public health agency.”
    • The MAHA in Action webpage features updates on federal reforms being implemented across HHS agencies, including removing petroleum-based dyes and harmful additives from the U.S. food supply, closing the GRAS loophole that allows chemicals into food often with unknown safety data, restoring public trust in vaccine safety and scientific transparency, and finding the root causes of the chronic disease epidemic including autism. * * *
    • “Explore the platform here and find out what changes are happening in your state.”
  • HCP Live tells us,
    • “On August 15, 2025, the US Food and Drug Administration (FDA) approved Tonix Pharmaceuticals’ TNX-102 SL, under the name Tonmya, for treating adults with fibromyalgia, the first new drug for the indication in more than 15 years.
    • “For many years, rheumatologists like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment needs for the majority of patients,” Philip Mease, MD, director of Rheumatology Research at the Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, said in a statement.1 “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”
    • “TNX-102 SL is a sublingual formulation of cyclobenzaprine and is also the first member of a new class of non-opioid analgesic drugs for fibromyalgia. Tonix originally announced the FDA’s acceptance of its new drug application for the medication in December 2024.

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about sodium consumption.
  • McKinsey and Company delves into “Closing the Black maternal-health gap: Healthier lives, stronger economies.”
  • The American Hospital Association News informs us,
    • “The Texas Department of State Health Services Aug. 18 announced that the state’s measles outbreak is over. The department said it had been more than 42 days since a new case was reported, surpassing the threshold to declare an end to an outbreak. There have been 762 confirmed measles cases during the West Texas-centered outbreak since late January. Of those, 99 individuals were hospitalized, and two school-aged children had died.”
    • “Nationwide, there have been 1,356 confirmed measles cases in 40 states this year, according to the latest Centers for Disease Control and Prevention data from Aug. 13. The vaccination status of 92% of all cases is classified as “unvaccinated or unknown.” 
  • Per a Senate news release,
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a statement following the Texas Department of State Health Services formally declaring the end of the measles outbreak in West Texas. It has been more than 42 days since a new measles case was reported in any of the counties that previously had ongoing transmission.
    • “I commend the Texas Department of State Health Services and the Trump administration for their work to stop this measles outbreak, saving lives in Texas and beyond,” said Dr. Cassidy. “But this tragedy was entirely preventable, and work must continue to curb outbreaks in other states. Misinformation about the measles vaccine fueled the spread of this outbreak, killing three Americans and hospitalizing many more. No child in the United States should ever die of a vaccine-preventable disease.”
    • “The measles vaccine is effective, safe, and the best way to protect yourself and your family from contracting this deadly disease. I encourage every parent to vaccinate their child to prevent needless death in the future,” continued Dr. Cassidy.”
  • Amen to that statement.
  • The Wall Street Journal reports,
    • “Gwen Orilio didn’t know how long she had to live after her stage-four lung cancer diagnosis. The disease had already infiltrated her eye, so the 31-year-old didn’t bother opening a retirement account.
    • “Ten years later, Orilio is still alive. And she still has metastatic cancer. 
    • “Keeping her going is a string of new treatments that don’t cure the disease but can buy months—even years—of time, with the hope that once one drug stops working a new one will come along. Orilio started on chemotherapy, and then switched to a new treatment, and then another, and another, and another.
    • “What’s next? What do I have lined up for when this one stops working?” said Orilio, a high-school math teacher who lives in Garner, N.C. “My motto is that the science just needs to stay a step ahead of me, and so far it’s been working.” 
    • “This past winter, she started a retirement fund at age 41. 
    • “Orilio is part of a new era of cancer treatment challenging the idea of what it means to have and survive cancer. A small but growing population is living longer with incurable or advanced cancer, navigating the rest of their lives with a disease increasingly akin to a chronic illness. The trend, which started in breast cancer, has expanded to patients with melanoma, kidney cancer, lung cancer and others.”
  • NBC News relates,
    • “More children died from the flu this past season than any year outside of the swine flu pandemic in 2009. Most of them were unvaccinated. 
    • “That’s why some doctors are hoping that the first nasal flu vaccine available for use at home can improve vaccination rates among people, especially children, who are afraid of needles. 
    • “AstraZeneca’s FluMist Home, which was approved last fall, is now available with a prescription for children ages 2 and over, and adults up to age 49.” * * *
    • “FluMist Home is available only online. People ordering the nasal spray will need to complete a medical screening questionnaire at FluMist.com that is reviewed by a health care professional, according to the drugmaker. FluMist Home’s online pharmacy will then collect the insurance information and bill the health plan directly.”
  • BioPharma Dive points out,
    • “A small, New Jersey-based drug developer plans to push an experimental psychedelic compound into late-stage testing now that it’s scored positive results in a postpartum depression study.
    • “That study enrolled 84 women with moderate to severe postpartum depression, each of whom received a single injection of Reunion Neuroscience’s “RE104” and were then monitored for four weeks. Participants were split into two groups. One got the full, 30 mg dose of RE104, while the other got a far lower dose and served as an “active control” arm.
    • “According to Reunion, the trial achieved its main goal as the 30 mg group showed significantly greater reductions on a widely used depression scale where lower scores indicate less severe symptoms. Seven days after treatment, scores in the experimental arm had fallen by 23 points, versus 17.2 points in the active control arm.
    • “Reunion said researchers also saw “clinically meaningful” responses in the higher dose group that started the day they received their injections and lasted through the 28-day follow up. Just over 77% had scores that improved by 50% or more one week after treatment. In the control arm, 62% hit that milestone. Between the two groups, 71% of the former achieved “remission” of their depression symptoms at Day 7, compared to 41% in the latter.
    • “Reunion said its drug — which functions similar to psilocybin, a molecule found in some psychedelic mushroom species — was well tolerated by patients. There were no serious adverse events, nor was there any treatment-emergent treatment-emergent seizures or suicidal ideation or behavior.”

From the artificial intelligence front,

  • A journalist and mother writing in the N.Y. Times, calls attention to a material weakness in AI chatboxes.
    • “Most human therapists practice under a strict code of ethics that includes mandatory reporting rules as well as the idea that confidentiality has limits. These codes prioritize preventing suicide, homicide and abuse; in some states, psychologists who do not adhere to the ethical code can face disciplinary or legal consequences.
    • “In clinical settings, suicidal ideation like [the journalist’s late daughter Sophie expressed] typically interrupts a therapy session, triggering a checklist and a safety plan. Harry [the AI chatbox] suggested that Sophie have one. But could A.I. be programmed to force a user to complete a mandatory safety plan before proceeding with any further advice or “therapy”? Working with experts in suicidology, A.I. companies might find ways to better connect users to the right resources.
    • If Harry had been a flesh-and-blood therapist rather than a chatbot, he might have encouraged inpatient treatment or had Sophie involuntarily committed until she was in a safe place. We can’t know if that would have saved her. Perhaps fearing those possibilities, Sophie held her darkest thoughts back from her actual therapist. Talking to a robot — always available, never judgy — had fewer consequences.
    • “Harry didn’t kill Sophie, but A.I. catered to Sophie’s impulse to hide the worst, to pretend she was doing better than she was, to shield everyone from her full agony. (A spokeswoman for OpenAI, the company that built ChatGPT, said it was developing automated tools to more effectively detect and respond to a user experiencing mental or emotional distress. “We care deeply about the safety and well-being of people who use our technology,” she said.)”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Fierce Healthcare is honoring its 2025 Most Influential Minority Executives.
    • “This year, we’re recognizing 11 leaders who are leading the charge in pushing healthcare forward. They represent influence across sectors, from provider organizations to payers to digital health, and are critical voices both in the U.S. and globally.
  • Check it out.
  • MedCity Dive notes,
    • “GLP-1s have proven to be highly effective for obesity but are extremely expensive and often have serious side effects, such as nausea, vomiting, dizziness and fatigue.
    • “That’s why Noom, a digital weight loss company, has introduced microdosing for GLP-1s. The company’s program involves beginning with a very low dose and gradually increasing to no more than 25% of the standard maintenance dose, with the goal of finding the lowest effective amount that supports weight loss while minimizing side effects and reducing cost.” * * *
    • “Is this microdosing program safe and effective? Noom says that due to the smaller doses, patients reduce the risk and intensity of side effects. The company also provides clinical oversight to ensure safety.
    • “However, at least one obesity medicine specialist isn’t so convinced that Noom’s microdosing offering is safe. And the concern isn’t so much with the prescribing of smaller doses, but the use of compounded GLP-1s, as they are not FDA-approved.
    • “The microdosing itself is not necessarily an issue. … For example, for patients on Ozempic for diabetes, we would off-label do this once in a while, especially when patients had more gastrointestinal side effects or they were losing weight faster than they wanted. … What I sort of take issue with Noom is that, one, I don’t know what medication or even substance somebody’s pumping into their bodies. And then two, what are the actual doses? Or what are the actual equivalents [compared to branded GLP-1s]?” argued Dr. Disha Narang, an endocrinologist and director of obesity medicine at Endeavor Health.”
  • Fierce Healthcare lets us know,
    • “National pricing data show the cost of healthcare services varies greatly by payer, geography, setting and facility, presenting new fiduciary considerations for employers.
    • “Since 2022, health plans have been required to release machine-readable files disclosing negotiated rates of healthcare services with providers. Hospitals are also required to release the costs of shoppable services.
    • “Data analytics firm Trilliant Health ingested UnitedHealthcare and Aetna transparency files from February to April 2025 to create a new report. Now, those massive swaths of information are slowly becoming more actionable for employers, they will need to plan accordingly, said Chief Research Officer Allison Oakes in an interview with Fierce Healthcare.
    • “Because this pricing information wasn’t historically available, employers weren’t necessarily responsible for picking the highest value health plan for their employees,” she said. “This also shifts the onus and responsibility to employers to use the leverage they have in the market to start changing some of this pricing as well.”
  • CVS Health highlights its value-based program for behavioral health care through clinical collaboration.
    • “There is still a clear need for high-quality, evidence-based behavioral health care in the U.S.
    • “One way to get there is through innovative payment models, including value-based care (VBC) models.
    • “The value-based care arrangement between Aetna, a CVS Health company and health plan, and virtual eating disorder provider Equip is an example of success. Of the Aetna members treated by Equip since 2021, 86% have made progress in their eating disorder treatment and the average reduction in eating disorder symptoms is 70%, validated through the Eating Disorder Exam Questionnaire (EDE-Q).
  • 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.” 
  • MedTech Dive tells us, “The Food and Drug Administration has authorized more medical devices that incorporate artificial intelligence. Keep track of the latest developments in this database” which MedTech Dive updated today.

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday report

David Ermer–CDC, CMS, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC

  • The OPM Director Scott Kupor announced an Award for Savings program which is open to OPM employees.
    • “For all savings identified between now and October 31, we will share 5% of the annual savings with whomever discovers it, up to $10,000 per award. To qualify, savings must be new actions not already identified, and we must be able to implement them.” 
  • Federal News Network reports,
    • “The Office of Personnel Management says new questions for federal job candidates, asking how they will advance the Trump administration’s policies, will appear on nearly all job applications, but candidates can still choose not to answer them without being penalized.
    • “OPM is telling agencies it is “mandatory” to include the Trump administration’s four new essay questions on nearly all applications on USAJobs, as part of the federal hiring process.” * * *
    • “In follow-up guidance, however, OPM downplayed the importance of the essays as just one piece of a candidate’s overall application. The HR agency said it’s optional for job candidates to answer the essays, and that candidates won’t be disqualified from consideration if they skip them.”
  • Federal News Network interviews Tammy Flanagan about smart tips to use when filling out the online federal retirement application.
  • NextGov/FCW tells us,
    • “The Trump administration is pushing forward in its deregulatory effort to overhaul the primary rules for how the government purchases goods and services, known as the Federal Acquisition Regulation.
    • “The FAR Council released new text for six parts of the FAR on Thursday — parts 4, 8, 12, 38, 40 and 51 — including the section dealing with commercial acquisition. 
    • “We’re removing hundreds of unnecessary requirements,” a senior administration official told Nextgov/FCW about the changes, offering the removal of requirements for commercial contractors to report the names and compensation of the five most highly paid executives as an example. 
    • “The goal is to reduce costs and time to deliver and increase competition, they said.”
  • The Wiley law firm has been doing a good job staying abreast of the FAR changes on its Decoding the FAR Overhaul website.
  • The American Hospital Association News points out,
    • “The White House Aug. 13 released an executive order directing the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response to develop a list of 26 drugs considered critical for national health and security. The order calls for the ASPR to gather a six-month supply of drug ingredients and place them in the Strategic Active Pharmaceutical Ingredients Reserve with a preference for domestic sourcing and manufacturing. The ASPR is also instructed to update a 2022 list of 86 essential medicines and propose a plan to obtain and store a six-month supply of drug ingredients for those remedies.”
  • and
    • “The Trump administration Aug. 13 issued an executive order revoking a 2021 order by the previous administration that established a “whole-of-government” effort to promote competition in the U.S. economy. The 2021 order encompassed 72 initiatives by more than a dozen federal agencies to address competition issues across the economy, including in health care, financial services, technology and agriculture. It also established a White House Competition Council tasked with coordinating, promoting and advancing federal efforts to improve competition in the U.S. economy.”
  • and
    • “The Department of Health and Human Services Aug. 14 announced it will reinstate the Task Force on Safer Childhood Vaccines, a federal panel to provide oversight on vaccines for U.S. children. The original task force was disbanded in 1998. HHS said the new group will work with the Advisory Commission on Childhood Vaccines to provide recommendations on developing, promoting and refining childhood vaccines that result in fewer and less serious adverse reactions than vaccines currently available, as well as improvements in vaccine development, production, distribution and adverse reaction reporting. 
    • “The new group will be led by senior leadership from the National Institutes of Health, the Food and Drug Administration and the Centers for Disease Control and Prevention. NIH Director Jay Bhattacharya will serve as chairman.” 
  • AHIP notes,
    • “A new peer-reviewed study published by The American Journal of Managed Care (AJMC) found that Medicare Advantage (MA) plans consistently delivered higher quality care than fee-for-service (FFS) Medicare before and during the COVID-19 pandemic.” * * *
    • “Nearly 35 million seniors and individuals with disabilities nationwide choose MA for their health coverage because it provides them with better care at lower costs than FFS. The new study’s findings add to a growing body of evidence that MA’s coordinated, value-based approach delivers superior quality and better health outcomes—while saving beneficiaries an average of more than $3,400 per year versus FFS.”
    • “Read the full study at AJMC, and learn more about the superior value of MA.”
  • Per Modern Healthcare,
    • “Penn Medicine and Saint Francis Health System recently received federal go-ahead to launch hospital-at-home programs, despite the program’s uncertain future.
    • “The Centers for Medicare and Medicaid Services’ Acute Hospital Care at Home waiver is set expire at the end of next month. Congress still must decide if it will extend or end the program, which provides Medicare reimbursement at the same rate for in-home care as in-facility care.
    • “Still, CMS approved waivers about two weeks ago for Tulsa, Oklahoma-based Saint Francis Health System’s program at two facilities.” 
  • and
    • “With just four months to go until a new, mandatory Medicare payment model commences, the hospital sector may be behind schedule.
    • “Health systems must ready themselves for the Transforming Episode Accountability Model, a five-year bundled payment demonstration known as TEAM, which sets episode-based fee-for-service Medicare reimbursements for five common procedures at nearly 750 hospitals.
    • “With just four months to go until a new, mandatory Medicare payment model commences, the hospital sector may be behind schedule.
    • “Health systems must ready themselves for the Transforming Episode Accountability Model, a five-year bundled payment demonstration known as TEAM, which sets episode-based fee-for-service Medicare reimbursements for five common procedures at nearly 750 hospitals.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “The Centers for Disease Control and Prevention (CDC) has not updated national measles statistics since August 6.  A notice on the CDC website that appeared after last week’s shooting said, “The data on this page will not be updated on Wednesday, August 13, 2025. CDC will resume updates as soon as possible.” * * *
    • “Colorado has reported a measles case in an unvaccinated child from Adams County who had recently traveled to Chihuahua state, which is Mexico’s measles hot spot. The child is under 5 years old and is hospitalized. * * *
    • “Idaho has confirmed its first measles case since 2023, in an unvaccinated child from Kootenai County. This county includes Coeur d’Alene, where measles was recently detected in wastewater. This marks the first confirmed case of measles in the Idaho panhandle since 1991.”
  • MedPage Today lets us know,
    • “In a nationally representative survey, 34% of U.S. adults were unaware of HPV and 38% were not aware of the HPV vaccine.
    • “Even individuals who were aware of HPV often didn’t know about its links to cervical and oral cancers.
    • “Public awareness of HPV and the HPV vaccine was lowest in Midwestern and Southern states.” * * *
    • “Given that the HPV vaccine has been approved in the U.S. for nearly two decades, “it was indeed surprising that a third of U.S. adults have not heard of HPV or the HPV vaccine,” Sonawane told MedPage Today. “Our hypothesis was in the range of 10% to 15%.”
  • Per the American Journal of Managed Care,
    • “Coinfection of HIV and HCV [Hepatitis C] leads to worse outcomes, necessitating effective HCV treatment in this population.
    • “Direct-acting antivirals show over 95% efficacy, yet HCV clearance rates in coinfected individuals remain below national targets.
    • “Study across seven U.S. jurisdictions showed modest increases in HCV clearance and testing rates among coinfected patients.
    • “Undetectable HIV viral loads and certain demographics, such as men who have sex with men, were linked to higher HCV clearance rates.
    • “Study limitations included incomplete data and potential COVID-19 pandemic impacts on results.”
  • Per Medscape,
    • “Hearing aid use was linked to fewer neuropsychiatric symptoms (NPS) in patients with dementia, such as apathy and irritability, than nonuse, new research showed.
    • “In a cross-sectional cohort study of more than 10,000 participants, hearing loss was not associated with a significantly greater number of symptoms than no hearing loss. However, the use of hearing aids in individuals with both dementia and hearing loss was linked to significantly fewer and less severe NPS than nonuse.
    • “Hearing aid use may represent an underutilized, nonpharmacological intervention to address NPS,” lead study author Ahjeetha Shankar, Johns Hopkins University School of Medicine, Baltimore, and colleagues wrote.”
  • Per Cardiovascular Business,
    • “Palliative care should play a significant role in the day-to-day management of heart failure (HF) patients, according to new recommendations from the Heart Failure Society of America (HFSA).
    • “HF patients are associated with high mortality and a considerably worse quality of life, the group wrote. Care teams should be doing everything in their power to help patients control their symptoms and live the best lives possible. 
    • “The HFSA guidance is available in full in the Journal of Cardiac Failure. * * *
    • “Click here to review the full consensus statement.”
  • STAT News reports,
    • “A study in rural China demonstrating the power of intensive blood pressure control clinched the deal. The large, cluster-randomized controlled trial convincingly demonstrated that well-controlled blood pressure — below 130/80 mm Hg — lowered the risk of dementia by 15% and cognitive impairment by 16%. 
    • “That was the solid evidence reviewers needed to form the foundation for a new guideline from leading medical groups on how to treat high blood pressure, Dan Jones, chair of the guideline writing committee and a past president of the American Heart Association, told STAT. He called the study from China the first one to definitively show that rigorous lowering of blood pressure with a goal of below 120 systolic does decrease the risk of dementia.”
    • “We don’t have recommended changes related to dementia but we are able to say with certainty that lowering blood pressure reduces the risk of dementia and that’s such good news for people around the world and for Americans,” said Jones, a former dean of the University of Mississippi School of Medicine.”
  • and
    • “In a small study, an engineered antibody showed “amazing” promise in countering metastatic cancer.
    • “That is, according to a Phase 1 clinical trial published Thursday in Cancer Cell. Researchers directly injected the drug, which stimulates the immune system to attack cancer cells, into 12 patients’ tumors. Six of the patients had significant tumor reduction even in non-injected sites, with two experiencing complete remission. The research could lay the groundwork for new treatments for the most advanced cancer patients.
    • “Seeing this in humans is really great news,” said Katelyn Byrne, a cancer biologist at Oregon Health and State University who was not involved in the study. “Especially for patients where we don’t have any options on the table, to be able to put this on the table now — it’s amazing.” 
  • The New York Times adds,
    • “Treating chronic pain is hard. An experimental approach shows promise.
    • “A guitarist in a death metal band was one of several people who found that personalized deep brain stimulation eased their pain and helped them reduce pain medication.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans tells us,
    • “U.S. employers project a median health care cost increase of 10% for 2026, according to new survey results from the International Foundation of Employee Benefit Plans. A similar Foundation survey conducted in 2024 projected a median cost increase of 8% for 2025.” * * *\
    • “When I spoke to Julie Stich, CEBS, Vice President of Content at the International Foundation, she shared that the 10% projected increase is attributed to a variety of factors impacting organizations’ medical plan costs, with catastrophic claims and specialty/costly prescription drugs topping the list. Employers have indicated that cost-sharing, plan design and purchasing/provider initiatives will be the most impactful techniques to manage costs.”
  • The Wall Street Journal reports,
    • “Pharma giant Eli Lilly said it is negotiating to raise drug prices in Europe, starting in the U.K. with the weight-loss drug Mounjaro, so that it can comply with the Trump administration’s goal of bringing down prices in the U.S.
    • “Lilly said Thursday that it has an agreement with the U.K. government to raise the list price of Mounjaro for patients who pay for it out-of-pocket. Lilly will more than double the list price of Mounjaro’s highest dose from about $165 to about $446. The new price is in line with the prices paid in the rest of Europe and other developed countries, Lilly said. 
    • “Mounjaro is the only Lilly medicine with a significantly lower list price in the U.K. than average prices in Europe and other developed countries, so we are adjusting the list price to bring it into line with these countries,” a Lilly spokesman said. 
    • “The higher price, however, won’t apply to those who get it prescribed through the U.K.’s National Health Service, the spokesman said.
    • “The move is part of the pharmaceutical company’s talks with foreign governments to raise prices in developed nations, the company said. It plans to implement any price adjustments by Sept. 1.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group and Amedisys have officially closed their $3.3 billion merger deal just one week after securing a key settlement agreement with the feds that allowed proceedings to advance.
    • “In a filing with the Securities and Exchange Commission, Amedisys said that the deal had officially closed Thursday, just over two years from when it was announced in late June 2023.
    • “That makes the home health company now a wholly-owned subsidiary of UnitedHealth, where it will join the company’s Optum unit. Amedisys was originally set to be acquired by Option Care Heath, but the organization was outbid by UnitedHealth.
    • “To make sure the merger was consummated, the two parties agreed last week to divest 164 home health and hospice facilities across 19 states, securing approval from the Department of Justice to move forward.”
  • and
    • “Humana and health tech company DrFirst are joining forces in a bid to close gaps in care for people with chronic health needs.
    • “The program’s initial launch focuses on boosting the use of statins among eligible members, which can improve care for people with cardiovascular conditions or diabetes while also meeting a key Medicare metric set by the Centers for Medicare & Medicaid Services.
    • “DrFirst’s prescription orchestration platform is embedded in the provider’s workflow, and through it, Humana can send the clinical team prescription recommendations for high-risk patients. Should they agree with the suggestion, the provider can then with one click submit a script and document why the care was necessary.
    • “I think it’s a very simple and very elegant way of helping the insurer and the provider get on the same page without requiring external workflows, external portals, external faxes,” Colin Banas, M.D., chief medical officer for DrFirst, said in an interview with Fierce Healthcare.
  • Per MedTech Dive,
    • “Apple said Thursday that it is updating its watches with a redesigned blood oxygen feature after a recent U.S. customs ruling. The software update will go out to the Apple Watch Series 9, Series 10 and Ultra 2 devices on Thursday.” * * *
    • “With the update, sensor data from Apple’s blood oxygen app will be measured, calculated and displayed in the paired iPhone app. Previously, the readings were displayed on the user’s watch. Apple said that there will be no change to previously purchased Apple Watches that have the original blood oxygen feature or devices sold outside of the U.S.”

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.”

Monday update

David Ermer–CDC, CMS, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM) today issued new government-wide guidance to ensure that performance awards are meaningfully targeted to the highest-performing federal employees. The updated policy directs agencies to strengthen performance management practices, normalize ratings, and reserve the largest awards and bonuses for employees who have demonstrated exceptional contributions to their agencyʼs mission. The guidance also encourages agencies to expand use of non-cash awards, such as time-off and quality step increases, and to recognize real-time accomplishments throughout the year
  • Per an HHS news release,
    • “Health and Human Services Secretary Robert F. Kennedy, Jr. visited the CDC headquarters in Atlanta today in response to Friday’s tragic gunfire attack that claimed the life of DeKalb County Police Officer David Rose. 
    • “CDC security led Secretary Kennedy on a tour of the Roybal Campus, pointing out shattered windows across multiple buildings, including the main guard booth. Health and Human Services Deputy Secretary Jim O’Neill and CDC Director Susan Monarez accompanied him on the tour. 
    • “Secretary Kennedy visited the DeKalb County Police Department, where he met with Police Chief Greg Padrick. Later, he met privately with the widow of Officer David Rose, who courageously gave his life in the line of duty. He offered his deepest condolences and reaffirmed the agency’s commitment to honoring Officer Rose’s bravery, sacrifice, and service to the nation.” 

From the judicial front,

  • It occurred to the FEHBlog this afternoon that we recently passed the August 7 deadline for the parties to submit a joint status report to the federal court considering a challenge to the Biden Administration’s 2024 mental health parity rule amendments.  
    • It turns out that the status report (Dropbox link) was timely submitted on August 7.
    • The parties reported,
      • “The Departments continue to consider whether to issue a notice of proposed rulemaking to revise or rescind the 2024 Rule and to determine when it would be appropriate to add a MHPAEA regulatory action to the agencies’ Semiannual Regulatory Agenda.
      • “Pursuant to the Court’s May 12, 2025, Minute Order, the parties will file another joint status report on or before November 5, 2025, to report on Defendants’ progress.” 
    • The most recent semi-annual regulatory report appearing on reginfo.gov is Fall 2024 dated 12/13/2024.
  • Fierce Healthcare reports,
    • “Hospital and health system groups are skeptical the Trump administration will have enough time to weigh and incorporate providers’ concerns before opening its 340B rebate pilot program up to drugmaker applicants. 
    • “In a letter sent to the Health Resources and Services Administration (HRSA), which oversees the controversial subsidy program, seven provider associations requested HRSA extend the timeline for stakeholder comments and give itself a broader window to consider public comments. 
    • “Specifically, the current timeline outlined by HRSA in late July requires comments on the program to be submitted by Sept. 8, and for drugmakers to submit their applications and rebate plans by Sept. 15. Approvals would be made by Oct. 15, and the pilot is slated to begin at the top of the year 
    • “Instead, the associations have floated a Sept. 15 comment period, an Oct. 20 manufacturer application deadline and a Nov. 3 approval date.
    • “With the fundamental changes a rebate model will impose on all 340B stakeholders, it is impossible for the agency to meaningfully consider, in just seven days, all the feedback it will surely receive,” the associations wrote in their letter (PDF). “Moreover, drug companies have spent years developing and preparing for a rebate model, but the agency’s current timeline would give 340B hospitals far less time to prepare.”

From the public health and medical research,

  • The American Medical Association lets us know what doctors wish their patients knew about joint injuries and treatment.
  • Consumer Reports, writing in the Washington Post, discusses “how to get more out of physical therapy. It can reduce pain, boost strength, get you as healthy as possible for surgery and more.”
  • Medscape lets us know what doctors wish their patients knew about “How High-Fiber Diets and Supplements Can Improve Health for Patients With Obesity.”
  • Per MedPage Today,
    • “Previous research on associations between prediabetes and mortality has produced conflicting results.
    • “This study found that prediabetes was statistically significantly associated with mortality only among adults ages 20 to 54 years.
    • “Mortality risk in younger adults could be due to metabolic or behavioral risk factors.” * * *
    • “Elizabeth Selvin, PhD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, who was not involved in the study, told MedPage Today that the findings were “very consistent with [the 2019 study] demonstrating that prediabetes in older adults is not strongly associated with mortality.”
    • “Current definitions of prediabetes are very broad and they capture a lot of people who are not at high risk for poor outcomes, especially in old age,” she said. “In older ages, mild elevations in glucose are extraordinarily common and seem to reflect mild metabolic dysfunction corresponding with aging rather than severe hyperglycemia that leads to diabetes.”
  • BioPharma Dive reports,
    • “An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits on Monday. 
    • “IO Biotech, however, still believes the vaccine performed well enough to warrant a potential approval consideration from U.S. regulators. The company noted how the study, which compared a regimen of its shot and Merck & Co.’s immunotherapy Keytruda to Keytruda alone, failed by the slimmest of margins. Executives also pointed to other analyses showing potentially stronger benefits among those who hadn’t previously received drugs like Keytruda or aren’t likely to respond to them. 
    • “It was a very narrow miss, just by a hair,” said Mai-Britt Zocca, IO’s CEO, on a Monday conference call with Wall Street analysts.
    • “Called Cylembio, IO’s cancer vaccine consists of engineered peptides that are supposed to provoke an immune response to certain proteins expressed on tumor cells. Those proteins are two of the immune “checkpoints,” PD-L1 and IDO1, long studied by drugmakers.”
  • and
    • “An experimental Novartis drug has succeeded against a tough-to-treat autoimmune condition, boosting the outlook for a multibillion-dollar acquisition the Swiss pharmaceutical company made last year. 
    • “According to Novartis, the drug, called ianalumab, met its main goal in two Phase 3 studies in Sjögren’s syndrome, a chronic and progressive immune disease. Novartis didn’t provide specifics, but said Monday that treatment with ianalumab led to statistically significant improvements in disease activity compared to a placebo in each trial, as measured by a widely used index evaluating symptoms. The drug was also “well tolerated” and demonstrated “a favorable safety profile,” the company said in a statement. 
    • “Novartis will share the findings at an upcoming medical meeting and submit them to global health regulators.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente closed its second quarter of the year with a billion dollars of operating income and a $3.3 billion bottom line—but operating headwinds on the horizon have leadership taking a hard look at the health system’s cost structure and potential efficiencies.
    • “The quarter’s performance is a step ahead of last year, when the integrated nonprofit reported $908 million of operating income and $2.1 billion in net income.
    • “It’s also a fair jump in the scale of Kaiser’s operations. Consolidated operating revenues and expenses during the most recent quarter were $32.1 billion and $31.1 billion, respectively, up from $29.1 billion and $28.2 billion in the second quarter of 2024. These reflect a 3.2% operating margin in the second quarter of 2025 and a 3.1% operating margin in the second quarter of 2024.
    • “Together with the year’s opening quarter, Kaiser now sits at about $63.9 billion of operating revenue and nearly $2 billion of operating income for the first half of the year. Kaiser said its operating income runs highest during the beginning of the year due to the timing of its health plan’s open enrollment”
  • Healthcare Dive tells us,
    • “Major for-profit hospital chains reported lower-than-expected volumes in second quarter earnings results, causing some to cut back on volume and earnings expectations for the year.
    • “Executives at the for-profit hospital chains — HCA Healthcare, Tenet Healthcare, Community Health Systems and Universal Health Services — attributed the volumes to different factors, from lower Medicaid admissions to a decline in consumer confidence, which impacted spending on healthcare services. 
    • “Softer volumes caused HCA, Tenet and CHS to lower their full-year outlooks for admissions. UHS did not report expectations for volume growth.”
  • Here are links to Kaufmann Hall’s June 2025 flash reports on hospitals and physicians, both of which were released today.
  • Beckers Hospital Review points out CMS’s 290 five star and 229 one star hospitals.
    • “Every year, CMS assigns star ratings to U.S. hospitals based on 46 hospital quality measures, which are divided into five categories: mortality, safety, patient experience, readmission rates, and timely and effective care. Data reporting periods range from July 2020 to December 2024, depending on the measure. The ratings were updated in July and released Aug. 6.” “
  • The American Journal of Managed Care informs us,
    • “Prescribing semaglutide in routine clinical practice was associated with meaningful—but smaller than seen in clinical trials—improvements in cardiovascular risk factors, along with an unexpected rise in non-drug health care spending, according to a new study published in JAMA Network Open.1
    • “Analyzing data from more than 23,500 adult patients across Yale New Haven Health System and Sentara Healthcare, researchers found that patients experienced an average 3.8% reduction in body weight and significant reductions in blood pressure (–1.5 mm Hg for diastolic; –1.1 for systolic), total cholesterol (–12.8 mg/dL), and hemoglobin A1c (HbA1C) at 13 to 24 months following their first semaglutide prescription. However, during the same time period, monthly health care expenditures rose by $80 per patient, not including the cost of semaglutide itself.
    • “These findings highlight a disconnect between clinical benefits and short-term cost savings, warranting caution when extrapolating trial-based projections to clinical settings,” the researchers said.”

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek report

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday report

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

From the Food and Drug Administration,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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