Midweek report

OPM

Midweek report

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical researach front,

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

From the U.S. healthcare business front,

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

Friday report

David Ermer–CDC, Congress, COVID-19, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Here is a link to OPM Director Scott Kupor’s second weekly blog post which is titled “Rightsizing with a purpose.”
  • The Wall Street Journal reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. is planning to remove all the members of an advisory panel that determines what cancer screenings and other preventive health measures insurers must cover, people familiar with the matter said.
    • “Kennedy plans to dismiss all 16 panel members of the U.S. Preventive Services Task Force because he views them as too “woke,” the people said.
    • “The White House has made a priority of targeting initiatives that promote diversity equity and inclusion, or DEI, in everything from artificial intelligence to health research grants.
    • “The task force has advised the federal government on preventive health matters since 1984. The Affordable Care Act in 2010 gave it the power to determine which screenings, counseling and preventive medications most insurers are required to cover at no cost to patients. The group, made up of volunteers with medical expertise who are vetted for conflicts of interest, combs through scientific evidence to determine which interventions are proven to work.
    • “The Supreme Court decided a case in June that centered on a task-force recommendation to cover HIV-prevention drugs. The employer plaintiffs in the case had argued that requiring them to cover such drugs for employees violated their religious rights and that the task-force members weren’t properly appointed. The high court ruled that the task- force appointments were constitutional, while highlighting that the Health and Human Services Secretary has the authority to remove the members of the panel at will.”
  • Per a Senate news release,
    • Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Maggie Hassan (D-NH), and Roger Marshall, M.D. (R-KS) highlighted the importance of fully implementing the No Surprises Act, which protects patients from surprise medical bills and ensures they know the cost of care before receiving it. This bipartisan legislation was signed into law by President Trump in 2020 as part of his efforts to improve price transparency and lower health costs for American patients.
    • “Nearly five years ago, President Trump signed the No Surprises Act (P.L. 116-260) into law. This historic, bipartisan legislation protects patients from surprise medical bills and ensures that they know the cost of care before receiving it,” wrote the senators. “Ensuring that patients have transparent, personalized cost estimates for their health care is a bipartisan priority. Full implementation of both the good faith estimate and advanced explanation of benefits are critical to providing patients with the entirety of protections enacted under the No Surprises Act…We commend President Trump’s commitment to price transparency and stand ready to assist to ensure a successful and complete implementation of the No Surprises Act.”
    • Since the bipartisan legislation led by Senators Cassidy and Hassan was signed into law by President Trump in 2020, the No Surprises Act has protected American patients from more than 25 million surprise medical bills. This would not be possible without the work of the Departments of Health and Human Services, Labor, and the Treasury.
    • To build on this success, the senators are requesting rules to implement provisions in the law to give covered patients clear cost estimates before their scheduled medical care. To date, the good-faith estimate has been implemented for uninsured and self-pay patients. Additional rulemaking is needed to implement the good-faith estimate and the advanced explanation of benefits for covered patients. For a patient with insurance, providers and facilities are required to provide the good-faith estimate to the individual’s health plan or issuer of coverage, which in turn, must use the estimate to give the patient an advanced explanation of benefits outlining what the plan will cover and what the individual will owe out of pocket.
    • Read the letter here 
  • If Congress wants to improve the No Surprises Act, it should refine the dispute resolution process.
  • Healthcare Dive tells us,
    • “More than 200 telehealth and provider organizations are asking the Trump administration to hammer out regulation governing telehealth prescriptions of controlled substances before pandemic-era flexibilities expire at the end of the year. 
    • “In a letter sent to Terry Cole, the newly confirmed administrator of the Drug Enforcement Administration, the groups urged the administration to ensure a plan is in place by fall so patients can continue to receive remote prescriptions of controlled substances.
    • “The Biden administration proposed a framework for telehealth prescriptions just before President Joe Biden left office in January, but some industry groups have panned the proposed rule as too onerous for providers.”

From the public health and medical research front,

  • The U.S. Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many Southeast, Southern, and West Coast states. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among young children 0-4 years old. COVID-19 model-based epidemic trends (Rt) and wastewater activity levels indicate that COVID-19 activity is increasing in many Southeast, Southern, and West Coast states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota’s CIDRAP adds,
    • “Emergency department visits rose 4.8% compared to the week before, mainly in children up to 4 years old. Test positivity rose slightly and is now at 5.3% nationally, with levels highest in the Southwest, followed by the South.
    • Wastewater SARS-CoV-2 detections remained at the low level and are highest in the West, with other regional hot spots, including Louisiana with very high activity and Florida with high activity.
    • “The CDC has not updated its variant proportion estimates since the middle of June owing to low numbers of sequences reported when the NB.1.8.1 subvariant was the most common. Variant proportions predicted from testing in international travelers during the same period suggested the XFG variant—one of many JN .1 offshoots— was most common. Both are considered variants under monitoring by the World Health Organization, which in late June said XFG seems to have a moderate growth advantage and a low risk of immune escape, though it added that confidence in its assessments were low because of recent expansion and low sequencing levels.”
  • The CDC also reports,
    • “Tetrahydrocannabinol (THC), a psychoactive substance found in Cannabis sativa plants, including varieties such as hemp, is increasingly being used in consumer products.
    • “During October 22–24, 2024, at least 85 persons, ranging from age 1–91 years, ate food from a restaurant in Wisconsin and experienced symptoms consistent with THC intoxication. The restaurant was in a building with a cooperative (i.e., shared) kitchen used by a state-licensed vendor who produced edible THC products. The restaurant mistakenly used THC-infused oil from the cooperative kitchen to prepare dough.
    • “Clinicians and public health practitioners should be alert to the possibility of mass THC intoxication events via food.
  • Doug Corley, MD, PhD, of The Permanente Medical Group, tells us why rising colon cancer rates—up 2% yearly in younger patients—demand earlier screening.
    • “Younger people are at increased risk compared to what they were,” said Doug Corley, MD, PhD, chief research officer for The Permanente Medical Group. Colorectal cancer “is a substantial problem, and it causes a lot of mortality … and morbidity.”
    • “The Permanente Medical Group is a part of the AMA Health System Member Program, which provides enterprise solutions to equip leadership, physicians and care teams with resources to help drive the future of medicine.
    • “Dr. Corley discussed the growing concerns about colon cancer in younger people, as well as how The Permanente Medical Group is helping these populations in a recent episode of “AMA Update.”
  • The American Hospital News lets us know,
    • “A report from AARP and the National Alliance for Caregiving released today found nearly 1 in 4 U.S. adults (63 million) are caring for an adult or child with a complex medical condition or disability. Over half of the caretakers are managing complex medical and nursing tasks like injections, wound care or medication management, though only 20% have training to do so.”
  • Per Medscape,
    • “Urgent care visits frequently result in inappropriate prescribing, with 12.4% leading to antibiotic fills, 9.1% to glucocorticoid fills, and 1.3% to opioid fills. Analysis of over 22.4 million urgent care visits revealed concerning patterns, including 40.8% of acute bronchitis visits resulting in inappropriate glucocorticoid prescriptions.” * * *
    • “Inappropriate prescribing in urgent care is influenced by clinician knowledge, patient demands, and lack of decision support. Antibiotic, glucocorticoid, and opioid stewardship programs are needed to reduce inappropriate urgent care prescribing and support long-term glucocorticoid and opioid deprescribing efforts,” wrote the authors of the study.”
    • “The study was led by Shirley Cohen-Mekelburg, MD, MS, Division of Gastroenterology and Hepatology and Institute for Healthcare Policy and Innovation, University of Michigan in Ann Arbor, Michigan. It was published online on July 21 in Annals of Internal Medicine.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Centene swung to a loss in the second quarter and offered a drastically reduced projection for full-year earnings, delivering a result even worse than Wall Street feared amid growing signs of a financial meltdown across the health-insurance industry.
    • “The managed-care company, which focuses on Medicaid, Affordable Care Act plans and Medicare, withdrew its earnings guidance for 2025 earlier this month, citing rising costs in Medicaid and problems in the ACA business. 
    • “Centene’s latest woes come after smaller competitor Molina Healthcare reduced its 2025 earnings projection for the second time in a month, and larger Elevance Health reported cost pressures as well. Industry bellwether UnitedHealth Group is set to report earnings next Tuesday, after earlier this year withdrawing its own guidance and replacing its chief executive. 
    • “The entire industry is contending with rising costs as well as a shifting membership and regulatory landscape across various lines of business that appear to have weakened insurers’ ability to predict the risks of the populations they enroll—a fundamental function.
    • Centene said in a conference call with analysts on Friday that it expects results to improve next year as it seeks higher payments and tightens its operations.” 
  • STAT News adds,
    • “Hospitals’ finances are strongly influenced by two factors: the prices they negotiate with insurers and how many patients they treat in their facilities. Right now, the latter does not appear to be the main driver of their strong profits. Inpatient and outpatient surgeries, which tend to be hospitals’ profit centers, were down slightly at both companies. Admissions barely budged. Another hospital chain, Community Health Systems, reported similarly underwhelming patient numbers this week. 
    • “It’s a different story among insurers, who say they’re being forced to shell out more money than usual for their members’ medical costs, particularly those who rely on Medicaid and Affordable Care Act plans. Elevance’s finance chief described what’s happening as a “market-wide morbidity shift,” meaning patients are sicker than the companies had expected when they priced their policies.
    • “One number may help explain why hospitals are faring well as insurers struggle: the amount of money hospitals make on each patient. In Tenet’s outpatient surgery business, revenue per case was up 8.3% year-over-year on a same-facility basis. In its hospital segment, that metric grew 5.2%. Tenet chalked that up to charging insurers higher prices — framed as patients having better-paying insurance — and its focus on offering higher-acuity services like cardiac care and orthopedics. At HCA, revenue per admission grew 4% year-over-year on a same-facility basis.”
    • “And consider which services are at issue for insurers. On the Medicaid front, Elevance said its members are using more home health, transportation, adult day care, and services to help them with daily activities like bathing and dressing. They’re also getting more behavioral health services and inpatient surgeries. As for people on ACA plans, the increase in care is concentrated among emergency room visits, behavioral health services, and high-cost drugs. 
    • “But on Friday, HCA said it’s seeing less demand for services among Medicaid patients.”
  • Here’s a link to a Beckers Hospital Review story about HCA’s second quarter earnings announcement.
    • “Nashville, Tenn.-based HCA Healthcare has reported “16 consecutive quarters of volume growth,” highlighting the strength of its diversified network of markets and services, CEO Sam Hazen said July 25 during the company’s second-quarter earnings call.
    • “The for-profit health system reported a 1.7% year-over-year increase in equivalent admissions for the second quarter and a 2.3% rise year-to-date. YTD managed care equivalent admissions — including the exchanges — increased 4%, in line with HCA’s expectations, according to CFO Mike Marks. Medicare grew 3%, slightly below the company’s expectations.
  • Per Beckers Payer Issues,
    • “With GLP-1 medication costs being a top concern for employers heading into 2026, UnitedHealthcare is addressing the challenge through its Total Weight Support program, aimed at improving weight loss outcomes for employees while managing the costs of medication adherence. 
    • “In our conversations and consultations with employers, they are all looking for solutions for their employees who are dealing with obesity and metabolic conditions that bring better value,” Rhonda Randall, DO, chief medical officer for UnitedHealthcare’s commercial business, told Becker’s. “Total Weight Support was put into the marketplace as a comprehensive solution for employers who are looking for that full-person approach to care for their beneficiaries and employees dealing with obesity.”
  • Mercer consulting offers detailed compliance consideration for GLP-1 drug coverage.

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call discusses expected floor activities this week on Capitol Hill.
  • The House Financial Services and General Government Subcommittee of the House Appropriations Committee will meet on Monday July 21 to mark up its appropriations bill which includes OPM appropriations.
    • The bill includes the following FEHB Program measures
      • Ban on applying full federal cost accounting standards on FEHB and PSHB carriers (Sec. 611).
      • Banning abortion coverage except “where the life of the mother would be endangered if the fetus were carried to term, or the pregnancy is the result of an act of rape or incest. (Sec. 614, also known as the Hyde Amendment).
      • A contraception mandate with certain exceptions (Sec. 726) which has been modified by the Affordable Care Act’s contraception mandate.
      • A new ban for 2026 (Sec. 761) which reads as follows:
        • “None of the funds made available by this Act, or in any previous appropriation, may be provided for in insurance plans in the Federal Employees Health Benefits program to cover the cost of surgical procedures or puberty blockers or hormone therapy for the purpose of gender affirming care.”
  • OPM Director Scott Kupor has begun writing a weekly blog about OPM. Here is a link to his first post which is worth reading. 
  • USA Today reports,
    • “Social Security recipients could get a 2.7% raise next year, up from last month’s estimate of 2.5%, based on the latest inflation report, according to a new estimate.
    • “The Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W), the index used to calculate the annual adjustment to Social Security benefits, gained 2.6% in June. Overall inflation rose 2.7%from May’s 2.4% increase. The Federal Reserve’s inflation goal is 2%.” * * *
    • [However,] Medicare Part B costs are rising several times faster than its average rate of increase in recent years.
    • “According to the 2025 Medicare Trustees annual report released in June [2025], the Medicare Part B premium for 2026, is expected to increase to $206.50 from $185.00 in 2025 for a jump of $21.50 per month, or 11.6%. That’s the largest Part B increase since 2022 when it rose 14.5%.” 
  • MedTech Dive informs us,
    • “A warning letter sent by the Food and Drug Administration to wearable company Whoop has sparked a debate on when wellness claims should be regulated as medical devices.
    • Whoop, a company selling a wearable wristband to track metrics such as sleep, heart rate and strain, received the warning letter on Monday for marketing a blood pressure insights feature without FDA authorization. 
    • “The feature provides daily systolic and diastolic blood pressure estimates by measuring heart rate variability during sleep. Whoop’s website states that the feature is intended to help users track blood pressure trends and have a deeper understanding of how blood pressure affects their wellness. The website also marketed the feature as an example of how Whoop is “delivering medical-grade health & performance insights,” according to the warning letter. 
    • “In a response posted Tuesday, one day after the letter was sent to the company, Whoop said it disagrees with the FDA’s assertion that the blood pressure feature should be reviewed as a medical device before being available in the U.S., claiming it is a wellness feature, not a medical device.
    • “This interpretation is also inconsistent with the 21st Century Cures Act, which clarifies that functions intended to promote a healthy lifestyle — and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition — are excluded from the definition of a medical device,” a Whoop spokesperson wrote in an emailed statement.” 

From the public health and medical research front,

  • The New York Times reports,
    • “Across the United States, an intricate system of hospitals, doctors and nonprofit donation coordinators carries out tens of thousands of lifesaving transplants each year. At every step, it relies on carefully calibrated protocols to protect both donors and recipients.
    • “But in recent years, as the system has pushed to increase transplants, a growing number of patients have endured premature or bungled attempts to retrieve their organs. 
    • “Across the United States, an intricate system of hospitals, doctors and nonprofit donation coordinators carries out tens of thousands of lifesaving transplants each year. At every step, it relies on carefully calibrated protocols to protect both donors and recipients.
    • “But in recent years, as the system has pushed to increase transplants, a growing number of patients have endured premature or bungled attempts to retrieve their organs. 
    • “Circulatory death donation is different. These patients are on life support, often in a coma. Their prognoses are more of a medical judgment call.
  • The FEHBlog certainly will be taking another look at his living will.
  • NPR Shots tells us
    • “After about age 40, our brains begin to lose a step or two.
    • “Each year, our reaction time slows by a few thousandths of a second. We’re also less able to recall items on a shopping list.
    • “Those changes can be signs of a disease, like Alzheimer’s. But usually, they’re not.
    • “Both of those things, memory and processing speed, change with age in a normal group of people,” says Matt Huentelman, a professor at TGen, the Translational Genomics Research Institute, in Phoenix.
    • “Huentelman should know. He helps run MindCrowd, a free online cognitive test that has been taken by more than 700,000 adults.”
    • “About a thousand of those people had test scores indicating that their brain was “exceptional,” meaning they performed like a person 30 years younger on tests of memory and processing speed.
    • “Genetics played a role, of course. But Huentelman and a team of researchers have been focusing on other differences.” * * *
    • “Early results suggest that sleep and maintaining cardiovascular health are a good start. Other measures include avoiding smoking, limiting alcohol and getting plenty of exercise.”
  • New York Times Well lets us know “Want More Self-Control? The Secret Isn’t Willpower. People who can delay gratification and master their impulses thrive in life. And experts say that you can learn skills to rein in bad habits.”
  • The Wall Street Journal reports,
    • “Long contentious, chronic Lyme, as it is called by patient advocates, has gained more acknowledgment and investment by researchers after Covid-19 showcased how an infection can leave people with lingering symptoms that last months or longer. The virus’s aftermath looked strikingly similar to what some Lyme disease patients had been describing for years.
    • * * * “In May, the National Academies of Sciences, Engineering and Medicine published a report saying that research funders should put more emphasis on developing treatments for patients with lingering symptoms after Lyme disease, even as the root cause behind why patients experience the symptoms remains a mystery.” * * *
    • “Some laboratory researchers are investigating what might be behind the symptoms, including whether a molecule that the bacteria left behind could be driving inflammation. Newer trials are now looking at whether certain antibiotics or electrical nerve stimulation might help treat the condition, since persistent infection and immune-system or neural-network dysfunction are also theories doctors have proposed. Prior trials haven’t found a benefit to more antibiotics after initial treatment.
    • “We’re not just focusing on one mechanism but many different possible mechanisms as to why people might have persistent symptoms,” said Dr. Brian Fallon, director of the Lyme and Tick-Borne Disease Research Center at Columbia University and head of the Lyme-focused clinical trial network that launched in 2021. 
    • “Preventing tick bites remains a person’s best defense against Lyme and other tickborne diseases. People should avoid wooded and brushy areas with high grass, walk in the center of trails and cover up extremities, health officials say. Wearing insect repellent, checking your body for ticks and showering soon after being outdoors also help reduce the risk.”
  • Modern Healthcare relates,
    • “People are beginning to trust AI for getting their health information, according to survey data from the Annenberg Public Policy Center of the University of Pennsylvania. Nearly eight out of 10 U.S. adults say they’re likely to look online for the answer to a question about a health symptom or condition. Of who are using AI, 75% say that AI-generated responses provide them with the answer they need. Most Americans (63%) think AI-generated health information is reliable.”

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Per a Congressional press release,
    • “Congressman Raja Krishnamoorthi (D-IL) and Congresswoman Diana Harshbarger (R-TN) introduced [on July 15, 2025] the Fair Pharmacies for Federal Employees Act, legislation to protect federal employees and retirees from anti-competitive practices by pharmacy benefit managers (PBMs) and insurers. Under the bill, the Office of Personnel Management (OPM) is prohibited from contracting with entities in the Federal Employee Health Benefits Program (FEHBP) that both manage prescription drug benefits and own or control a pharmacy. The federal government administers and oversees the largest employer-based health care system in the country. By implementing comprehensive reform at the federal level, a proven model will be created that will lower health care costs across the board beyond the federal workforce and reach millions of Americans impacted by anti-competitive practices used by PBMs.” * * *
    • “The full text of the legislation is available here.”
  • This proposal would be very disruptive to the FEHB Program’s prescription drug benefits. Indeed, the FEHB Program’s prescription drug benefits would benefit from deregulation. 
  • Federal News Network reports,
    • “Employee departures at the Office of Personnel Management are contributing to the agency’s ongoing challenges with addressing fraud risks in the Federal Employees Health Benefits program.
    • “A new report from the Government Accountability Office dug into whether OPM had considered assessing various factors that create risks for fraud in the government’s health insurance program for federal employees. But partially due to recent staffing vacancies, OPM was unable to provide a clear answer.
    • “OPM officials “could not explain or provide documentation as to whether these inherent risks were considered as part of the assessment process, and why the resulting fraud risk profile does not address these risks,” GAO wrote on Thursday.
    • “Amid the overhauls that have taken place in OPM’s internal workforce over the last several months, agency officials who were previously responsible for conducting fraud risk assessments have left their jobs, according to GAO’s report.”
  • FEHB carriers, which hold the insurance risk, bear the laboring oar on fraud risk assessments. Carriers work closely with the Office of Inspector General.
  • STAT News informs us,
    • “The Trump administration is opening the floodgates for more surgeries to be done in outpatient facilities like ambulatory surgery centers, proposing a Medicare policy that could accelerate the shift away from hospital-based care. 
    • “The administration is aiming to scrap Medicare’s list of 1,700 procedures that the program will only pay for in inpatient settings. Medicare officials unveiled their decision to eliminate the so-called inpatient only list in a proposed rule on Tuesday, reprising an effort from the first Trump administration. 
    • “The agency had already removed common surgeries like hip and knee replacements from the list in recent years, but it said that getting rid of it entirely will give patients more choices and allow doctors to use their professional judgment to decide where procedures should take place. 
    • “Doctors, for their part, raised a number of concerns with the change, noting that it could jeopardize insurance coverage for inpatient surgeries and raise out-of-pocket costs for patients. But far and away their main issue with eliminating the list was the potential to endanger patients if the shift happens too quickly and with the wrong patients.
    • “I wouldn’t say that most doctors are going to be cowboys about it, but they may be working in health systems where they say, ‘Hey we want to get x-percent of these procedures done in the outpatient setting,’” said Andrew Ibrahim, an associate professor of surgery at the University of Michigan. “There may be nudges from their health system or the way their practice is set up.” 
  • The Washington Post reports,
    • “Partnerships between telehealth companies and pharmaceutical giants Pfizer and Eli Lilly raise concerns about conflicts of interest and inappropriate prescribing, according to a Senate investigation released Thursday.
    • “The report by offices of several Democratic senators said the arrangements appear intended to steer patients to medications manufactured by those companies, which maintain websites touting drugs and providing links directing them to doctors who can prescribe them.
    • “Such partnerships undermine the independent medical judgment of doctors, who may default to prescribing medications first instead of exploring other options and potentially “glossing over the comprehensive evaluation necessary for high-quality patient care,” concluded the report from the offices of Sens. Dick Durbin (D-Illinois), Bernie Sanders (I-Vermont), Elizabeth Warren (D-Massachusetts) and Peter Welch (D-Vermont).
    • “In statements, Eli Lilly and Pfizer said their online portals are meant to make it easier for patients to navigate health care and they do not pressure clinicians to prescribe their drugs.”
  • Per a CMS press release,
    • “The Centers for Medicare & Medicaid Services (CMS) continue to crush fraud, waste, and abuse in America’s healthcare programs by stopping duplicative enrollment in government health programs, with the potential to save taxpayers approximately $14 billion annually.
    • “A recent analysis of 2024 enrollment data identified 2.8 million Americans either enrolled in Medicaid or the Children’s Health Insurance Program (CHIP) in multiple states or simultaneously enrolled in both Medicaid/CHIP and a subsidized Affordable Care Act (ACA) Exchange plan. 
    • “CMS is taking action to ensure individuals are only enrolled in one program and to stop the federal government from paying multiple times for these individuals to receive health coverage. In addition, as a result of the One Big Beautiful Bill Act, CMS now has new tools to prevent the federal government from paying twice for the same person’s care—saving billions and restoring integrity to the system.”
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services July 17 issued two letters to states regarding policies on continuous eligibility and workforce initiatives. The agency said it does not anticipate approving new or extending existing section 1115 demonstration authorities, which expand continuous eligibility. Additionally, CMS said it does not anticipate approving new or extending existing Medicaid-funded workforce initiatives for training or employment-related activities.”
  • Govexec tells us,
    • “In his first public memo since his Senate confirmation last week, Office of Personnel Management Director Scott Kupor wrote that due to the 2023 Supreme Court case Groff v. DeJoy, which held that employers must demonstrate “substantial increased costs” if they deny an employee’s religious accommodation request, federal agencies should work to honor such requests from their employees.
    • “Agencies are encouraged to adopt a generous approach to approving religious accommodations, prioritizing employee needs while maintaining operational efficiency,” Kupor wrote. “Further, federal agencies must adhere to the requirements of Title VII [of the 1964 Civil Rights Act] and the Groff clarification of the ‘undue hardship’ standard when addressing religious accommodation requests.”
    • “Agencies may use a number of workplace flexibilities to address an employee’s religious accommodation request, including telework, compensatory time off, flexible and maxiflex work schedule, and both paid and unpaid leave. Telework in particular can be useful to accommodate observing—or preparing to observe—a religious holiday or sabbath observance, to engage in religious fasting or other time-specific prayer observances.”
  • Tammy Flanagan, writing in Govexec, lets us know that “OPM’s digital retirement application is live. What that means for feds planning to retire. The new electronic retirement system promises a faster, more accurate process, but some users are still adjusting to the change.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “In a surprise, advisers to the Food and Drug Administration on Thursday voted that the risks tied to a blood cancer drug from GSK outweighed the benefits it had demonstrated in trials, as concerns about sometimes serious eye-related side effects and questions about the dose the company selected dominated a hearing.
    • “The FDA is set to decide whether to approve the drug, called Blenrep, by as soon as next week. The agency often follows its advisers’ recommendations but does not have to.”
  • The AHA News relates,
    • “The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium. The FDA said the inadvertent administration of cefazolin following a recommended dosage of penicillin G potassium could pose serious and potentially life-threatening health consequences. Sandoz has not received any reports of adverse events or injuries related to the mislabeling but has received a complaint of the mislabeled product being administered to a patient.” 
  • Per MedTech Dive,
    • “Integra Lifesciences has recalled cranial drills over a defect linked to 10 injuries, the Food and Drug Administration said Wednesday.
    • “The company has asked customers to return Codman cranial perforators because they may break apart during use, causing the device to become lodged in the patient’s skull or injure the brain.
    • “Integra began the recall months after the FDA sent a warning letter to three facilities that make products including cranial perforators.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “A new lawsuit brought by 20 Democratic attorneys general says a recent final rule by the Centers for Medicare & Medicaid Services (CMS) will make it unfairly difficult to obtain health insurance through the Affordable Care Act (ACA).
    • “The lawsuit mirrors a challenge by three cities and liberal advocacy groups earlier this month. Plaintiffs in both cases say the regulation will cause up to 1.8 million people to lose coverage, starting in 2026. Many more will see premiums increase and out-of-pocket costs soar.
    • “Thursday’s suit (PDF) also takes issue with a provision in the rule, finalized in June, barring federal funds toward gender-affirming care services as an essential health benefit under the ACA.
    • “The states hope to delay the rule from taking effect in August.”

From the public health and medical research front,

  • The AP reports,
    • “Health officials in Illinois and North Dakota say their states’ measles outbreaks are over, pointing to a continuing slowdown of measles spread in the U.S. during vaccine-preventable disease’s worst year since 1991.
    • “Wednesday’s national case count stood at 1,309 — 21 new cases in a week, according to the U.S. Centers for Disease Control and Prevention. Last week, the U.S. passed the total count for 2019, when the country almost lost its status of having eliminated measles. 
    • “A vast majority of this year’s cases are from Texas, where a major outbreak raged through the late winter and spring. Other states with active outbreaks — which the CDC defines as three or more related cases — include Arizona, Colorado, Georgia, Iowa, Kansas, Kentucky, Michigan, Missouri, Montana, New Mexico, Oklahoma and Utah. 
    • “There have been three deaths in the U.S. this year, and all were unvaccinated: two elementary school-aged children in West Texas and an adult in New Mexico.”
  • The Washington Post relates, “Flesh-eating bacteria has killed 4 in Florida. Here’s what to know. Four people in Florida have died this year after contracting Vibrio vulnificus. Though rare, infections can require intensive care or limb amputation.”
  • The International Foundation of Employee Benefit Plans offers detailed advice on how to improve GI health in the workforce.
  • The National Science Foundation points out “AI that delivers smarter glucose predictions without compromising privacy.”
  • Per MedCity News,
    • “Over the past decade, employer-sponsored healthcare has undergone a significant transformation. Mental health solutions are finally mainstream. Fertility benefits are expanding. Women’s health has received overdue attention and innovation. Yet amid this evolution, one critical area remains largely ignored: men’s health.
    • “More than 88% of working-age men have unmet preventive, reproductive, and hormonal health needs. Despite making up half the workforce, men are falling through the cracks of today’s benefits strategies, often suffering in silence, delaying care, and showing up at the doctor’s only when it’s too late.
    • “For employers, this is more than a missed opportunity. It’s a growing liability financially, operationally, and culturally. Men’s health must be redefined not just as a clinical issue, but as a strategic business lever.”
  • Per STAT News,
    • “After a decade-long rise in suicide rates among young Americans — and with depression diagnoses soaring in this age group during the pandemic — the U.S. surgeon general issued a report in 2021 warning about the “devastating” state of youth mental health. The American Psychological Association declared it a “crisis.”It was part of a prolonged advocacy campaign to raise awareness about the problem and possible solutions, and finally, in 2022 and 2023, there were signs of success: Suicide rates for teens and young adults began to fall.
    • “Meanwhile, another demographic has gone largely overlooked. The people most at risk from suicide aren’t those in crisis in adolescence or midlife, but men age 75 and older. Some 38.2 deaths per 100,000 among men age 75 to 84 are by suicide, which increases to 55.7 among those over 85, according to data from CDC — more than 16 times the suicide rate for women in the same age group. Researchers are calling for a public health effort, much like the one to treat youth mental health, to help address suicide in older men.”
  • and
    • “Expert guidelines that clinicians across the country use to assess the risk of preeclampsia in pregnant women may be ineffective.
    • “The recommendations designed by the U.S. Preventive Services Task Force do not accurately predict risk of developing the condition and lead to nonspecific treatment guidance for the majority of patients, researchers found in a study published Thursday in JAMA Network Open. The findings have implications for reforming risk guidelines and increasing personalized care.
    • “This is a valuable, descriptive study,” Molly McAdow, a maternal-fetal medicine specialist at Yale New Haven Hospital, said. “There is certainly an opportunity for us to do better with a more stringent screening test.”
  • Per Health Day,
    • “Doctors might be overlooking a common cause of high blood pressure.
    • “New guidelines recommend screening for primary aldosteronism.
    • “Too much of the hormone aldosterone causes low potassium and high sodium, leading to high blood pressure.”
  • and
    • “Bedtime dosing with antihypertensive medication yields better nocturnal blood pressure control and improved circadian rhythm, according to a study published online July 9 in JAMA Network Open.”
  • Beckers Hospital Review relates,
    • “Pfizer is warning physicians that it expects a new shortage of Bicillin L-A, a long-acting penicillin injection that is currently the single recommended treatment for syphilis during pregnancy, CNN reported July 16. 
    • “The drugmaker’s alert follows a July 10 recall of certain lots found to contain floating particles, which Pfizer traced to faulty stoppers from an outside vendor. The company said no adverse reactions have yet been reported. 
    • “We have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,” the company said in a statement to the news outlet. “We fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Elevance on Thursday became the fourth major health insurer to lower or scrap its profit forecast, and executives warned things are going to get worse for the embattled sector before they get better. 
    • “Like its peers, Elevance said its members are getting a lot more care than the company had projected. For Elevance, the uptick is more pronounced in its Affordable Care Act business, but it’s also happening in Medicaid. The company lowered its full-year profit outlook by 13% to account for the higher costs, which are also baked into the plans it’ll sell in 2026. 
    • “We recognize that revising guidance for the second consecutive year is disappointing,” Gail Boudreaux, Elevance’s CEO, said on the company’s earnings call. “We remain committed to transparency and strong execution as we continue to navigate unprecedented cost trends affecting multiple lines of business.” 
  • Modern Healthcare lets us know,
    • “Group healthcare costs are expected to increase by 8.5% in 2026.
    • “PricewaterhouseCoopers’ Health Research Institute based its forecast published Thursday on policy changes, expensive medications including glucagon-like peptide agonists, higher rates of behavioral health claims and increased use of artificial intelligence, among other factors.
    • “For PwC’s annual report, researchers spoke with actuaries at 24 different health insurers covering 125 million employer-sponsored members and 12 million Affordable Care Act members to forecast healthcare inflation. In addition to the predicted 8.5% jump in costs for the group market, the consultancy projected a 7.5% increase for the individual market.”
  • The Wall Street Journal reports
    • “The drugmakers Bristol-Myers Squibb and Pfizer plan to sell the widely used blood thinner Eliquis directly to patients at a discounted cash price—a move that follows the Trump administration’s pressure on the industry to cut drug prices.
    • “The companies, which have a joint venture that markets Eliquis, said the new service will allow uninsured or underinsured patients to buy the pill at more than 40% off the current list price starting Sept. 8. The service will provide direct shipping of the drug to patients in the U.S.
    • “The BMS-Pfizer Alliance is committed to increasing patient access and affordability, which is why we are launching this direct-to-patient offering for Eliquis,” said Bristol-Myers Chief Executive Christopher Boerner.” * * *
    • “Eliquis has a list price of $606 for a 30-day supply but will now offer a discounted cash price of $346 a month.”
  • BioPharma Dive notes,
    • “Abbott lowered its sales forecast for the year, citing a drop in diagnostic testing. CEO Robert Ford told investors on Thursday that the company is seeing a drop-off in COVID-19 testing sales, challenges in China’s core laboratory market and a reduction in U.S. foreign aid funding for HIV testing, with a combined impact of more than $1 billion. 
    • “The company reduced its 2025 organic sales growth forecast to a range of 6% to 7%, from the previous forecast of 7.5% to 8.5% shared in the first quarter.
    • “Even with those billion dollars, we’re still forecasting high single-digit growth and absorbing the impact of tariffs,” Ford said.” 
  • Beckers Hospital Review calls attention to “10 healthcare billing fraud cases that Becker’s has reported on since June 30.”
  • The Institute for Clinical and Economic Review posted today
    • “a revised Evidence Report assessing the comparative clinical effectiveness of nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA). ICER is also assessing the comparative clinical effectiveness and value of apitegromab (Scholar Rock Holdings) for SMA.”
    • “SMA, in its most common forms, has been a devastating degenerative neurologic disease of infants and children,” said ICER’s Chief Medical Officer, David Rind, MD. “Disease modifying therapies and newborn screening have dramatically altered the course of disease and represent one of the great medical success stories in the past decade. However, we still have important uncertainties about how best to utilize these therapies to provide maximal benefits to those affected.” * * *
    • “ICER evaluated the cost-effectiveness of apitegromab only because it will most likely be used as an add-on therapy to nusinersen or risdiplam. Apitegromab has not yet been approved by the FDA for SMA, and the manufacturers have not yet announced a US price for the therapy if approved. 
    • “ICER has calculated a health benefit price benchmark (HBPB) to be between $4,600 and $30,200 per year.” * * *
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on August 1, 2025. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

Midweek update

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

David Ermer–CDC, CMS, FDA, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • OPM and FedSmith report on yesterday’s swearing in ceremony for OPM’s new director Scott Kupor.
    • “I am honored by the Senate’s confirmation and grateful to President Trump for entrusting me with this opportunity to serve,” Director Kupor said. “The federal workforce is the backbone of our government’s ability to deliver for the American people. My commitment is to empower these dedicated public servants with the tools, systems, and leadership they deserve, building a high-performing, accountable, and mission-driven workforce that upholds the trust of every taxpayer.
    • “I will prioritize President Trumpʼs America-first agenda by focusing on a smart stewardship of taxpayer resources, fostering a workplace culture that rewards innovation and performance, and ensuring federal agencies are equipped to serve Americans with efficiency and integrity,” Kupor continued. “Throughout my career, I have worked to champion organizational excellence. As Director of OPM, I will apply these experiences to modernize how the federal government attracts, develops, and retains top talent.”
  • Federal News Network reports,
    • “The Trump administration is continuing to keep the details of agencies’ reorganization and staff reduction plans out of the public eye, according to court documents the government’s lawyers filed on Monday.
    • “U.S. District Court Judge Susan Illston last week ordered the Trump administration to submit a list of the 40 reduction-in-force actions across 17 agencies that government officials told the Supreme Court are ready for implementation. Illston’s order comes after the Supreme Court allowed agencies to move forward with agency RIF and reorganization plans (ARRPs) on July 8.
    • “In its response this week to Illston’s order, the government refused to disclose details about agencies’ planned staffing reductions and opted not to submit a court-ordered list of dozens of expected RIFs. Instead, the government’s lawyers said the information is “privileged” and argued that there is “no lawful basis” for Illston to order the disclosure of a list.
    • ‘Rather than turning over a list of agencies’ planned RIFs, the government’s lawyers said they plan to file a motion to dismiss the case within the next week.”
  • Bloomberg Law reports,
    • “President Donald Trump said that he was likely to impose tariffs on pharmaceuticals as soon as the end of the month and that levies on semiconductors could come soon as well, suggesting that those import taxes could hit alongside broad “reciprocal” rates set for implementation on Aug. 1.
    • “Probably at the end of the month, and we’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we’re going to make it a very high tariff,” Trump told reporters Tuesday as he returned to Washington after attending an artificial intelligence summit in Pittsburgh.” * * *
    • “Trump on Tuesday predicted that he could strike “two or three” trade deals with countries before implementing his so-called reciprocal tariffs before they are implemented on Aug. 1, saying that an agreement with India was among the most likely.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.1 This action reflects the Agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores. While 7-OH occurs naturally in trace amounts in kratom, the Agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous. 
    • “7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use.”

From the CMS front,

  • Fierce Healthcare tells us,
    • The Centers for Medicare & Medicaid Services’ [CMS] annual pay rate proposal for outpatient and ambulatory surgical centers (ASCs) includes a step toward site-neutral payments, a broader list of services eligible for outpatient reimbursement, updates to hospital price transparency rules and several quality rating methodology updates.
    • “We are advancing our mission to protect Medicare and its beneficiaries, fight fraud and empower patients with access to the latest innovations, all while holding providers accountable and ensuring taxpayer dollars are spent wisely,” CMS Administrator Mehmet Oz, M.D., said in a Tuesday afternoon release. “These reforms expand options and enforce the transparency Americans deserve to ensure they receive high-quality care without hidden costs.”
    • The Calendar Year 2026 Outpatient Prospective Payment System (OPPS) and ASC Payment Systems proposed rule is headlined by a 2.4% proposed payment rate increase for hospitals that meet applicable requirements for quality reporting. It reflects a projected 3.2% hospital market basket increase and a required productivity adjustment of 0.8 percentage points, and is estimated to increase OPPS expenditures approximately $8.1 billion over 2025’s estimated payments.
  • Following up on yesterday’s post, Fierce Healthcare points out,
    • “The Centers for Medicare & Medicaid Services released the proposed physician fee schedule on Monday evening, which would set the conversion factor, or the amount that Medicare pays per work relative value unit, at $33.42, an increase of 3.62% over the 2025 rate of $32.35.
    • “That increase accounts for a 2.5% payment adjustment required by the Big Beautiful Bill Act, and a bump of 0.55% to account for changes to some RVUs, per a fact sheet on the rule.
    • “The agency also said it intends to set the conversion rate in qualifying alternative payment models at $33.59, an increase of 3.83%.”
  • CMS also announced today,
    • “The Centers for Medicare & Medicaid Services (CMS) announced today that 33 states, plus the District of Columbia and Puerto Rico, will participate in the Cell and Gene Therapy (CGT) Access Model, a bold new approach to delivering cutting-edge treatments for people on Medicaid living with sickle cell disease. Participating states represent approximately 84% of Medicaid beneficiaries with the condition, significantly expanding access to transformative care.” * * *
    • “The following states and territories are participating in the CGT Access Model: Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, and Wisconsin, as well as the District of Columbia and Puerto Rico.
    • “To learn more about the Cell and Gene Therapy Access Model, visit:  www.cms.gov/priorities/innovation/innovation-models/cgt.

From the public health and medical research front,

  • Health Day lets us know,
    • “Cancer deaths linked to obesity more than tripled in the U.S. during the past two decades, a new study says.
    • “Deaths linked to the 13 types of obesity-related cancer rose to 13.5 deaths per million from 3.7 deaths per million between 1999 and 2020, researchers reported Sunday at the Endocrine Society’s annual meeting in San Francisco.
    • “Obesity is a significant risk factor for multiple cancers, contributing to significant mortality,” said lead researcher Dr. Faizan Ahmed of Hackensack Meridian Jersey Shore University Medical Center in Neptune City, N.J.
    • “This research underscores the need for targeted public health strategies such as early screening and improved access to care, especially in high-risk rural and underserved areas,” Ahmed added in a news release.”
  • MedPage Today warns us that “Two separate manufacturers of needle mushrooms and cremini mushrooms recalled their products for potential Listeria monocytogenes contamination.
  • The American Hospital Association News relates,
    • “A Health Affairs study on the decline of obstetric services in rural and urban hospitals nationwide from 2010-2022 found that seven states had at least 25% of their hospitals report they are no longer providing obstetric services. Additionally, by 2022, more than two-thirds of rural hospitals in eight states were without obstetric services.
    • “In five states, 25% or more of their urban hospitals no longer reported providing obstetric services by 2022, but this was more pronounced in rural areas, with a total of 12 states experiencing 25% or more losses of obstetric services in rural hospitals. The study examined AHA survey data as well as information from the Centers for Medicare & Medicaid Services Provider of Services files.”
  • The July 15, 2025, issue of NIH Research Matters covers the following topics: “Lung cancer in never-smokers | CAR T cells | Measuring aging from brain images.”
  • The Washington Post interviews “a gastroenterologist, here’s what she eats in a day to boost her gut health. Studies have shown that a high-fiber diet can also lower the risk of heart disease and cancer and improve longevity.”
  • The Wall Street Journal calls attention to the fact that “a growing number of female scientists, entrepreneurs and influencers are edging into a space long dominated by men [, the study of human longevity]. Their study of hormones and ovaries could unlock the key to a longer life for everyone.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Teladoc Health is launching an employee assistance program as the virtual care giant looks to boost its mental healthcare offerings. 
    • “The program, called Wellbound, includes online therapy through its direct-to-consumer mental healthcare unit BetterHelp, as well as additional psychiatry and medication management services provided through Teladoc, the telehealth vendor said Tuesday.
    • “The EAP will also be able to connect users to Teladoc’s other services, like primary care and chronic condition management programs.”
  • Beckers Payer Issues lets us know,
    • “EmblemHealth is enlisting AI agents to help keep members cool this summer. 
    • “Extreme heat is a silent killer, said Dan Knecht, MD, EmblemHealth’s chief medical officer. In New York City, where EmblemHealth is based, more than 500 people die from extreme heat each year. 
    • “This summer, EmblemHealth launched its weather resilience program, designed to find members at risk of heat-related illness, and provide them with information and resources. 
    • “The health plan uses data about members’ age, chronic conditions and other factors, combined with public data from New York City’s heat vulnerability index, to identify members at risk. Then AI voice agents are used to contact members, providing information about heat safety, cooling centers and other resources. 
    • “The program has reached over 2,600 members as of July 8.” 
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “ICER today released a Final Evidence Report assessing the comparative clinical effectiveness and value of for the treatment of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).” * * *
    • “Tolebrutinib has not yet been approved by the FDA, and the manufacturer has not announced a US price if approved. 
    • “Consistent with ICER’s process, because there is no firm estimate yet of a potential launch price for the treatment, the panel did not take a vote on the treatment’s long-term value for money. 
    • “ICER has calculated a health benefit price benchmark (HBPB) to be between $3,250 and $5,900 per year.”