Friday report

David Ermer–CDC, Congress, FDA, Medical / Rx research, NCQA, Obesity, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Democrats again blocked Republicans’ seven-week stopgap spending bill, effectively guaranteeing that the government shutdown will stretch into next week, while the Trump administration froze funding for a Chicago transit project in its latest swipe at blue cities and states.
    • “The GOP measure failed with 54 in favor, and 44 opposed. Republicans control the chamber 53-47 but needed 60 votes to advance the measure under Senate rules.
    • “Earlier Friday, the Trump administration said it is freezing $2.1 billion in federal funds allocated for Chicago in its latest budgetary maneuver targeting Democratic priorities and projects during the shutdown.” 
  • Our OPM Director remains on the job. Today’s Secrets of OPM blog post from Director Scott Kupor discusses OPM’s efforts to handle the retirement surge stemming from the Fork in the Road program.
  • Tammy Flanagan, writing in Govexec, offers “Some good news for federal employees: TSP shows steady growth and healthy fund performance. The Thrift Savings Plan has surpassed $1 trillion in assets, providing steady returns in 2025.”
    • “There has been a lot to worry about for federal employees and their benefits in 2025, but one thing that has been doing very well is the Thrift Savings Plan! The TSP will continue its normal daily operations during the current lapse in appropriations. Visit tsp.gov/shutdown/  for additional information and updates.”  
  • NCQA, writing in LinkedIn, discusses what the organization has learned about defining best practices in wellness and patient engagement.

From the Food and Drug Administration front,

  • Per MedPage Today,
    • “The FDA approved lurbinectedin (Zepzelca) plus either atezolizumab (Tecentriq) or atezolizumab and hyaluronidase (Tecentriq Hybreza) as first-line maintenance therapy for extensive-stage small cell lung cancer, the agency announced on Thursday.
    • “As the first approved combination in this setting, lurbinectedin-atezolizumab is indicated for patients whose disease has not progressed after atezolizumab, carboplatin, and etoposide induction therapy.”
  • and

From the judicial front,

  • SCOTUSblog provides us with news from this week’s long conference.
    • “The Supreme Court on Friday morning agreed to hear oral arguments this winter in a challenge to a Hawaii law that makes it a crime for someone who has a concealed carry permit to carry a handgun on private property without the property owner’s affirmative permission. The announcement that the justices will take up Wolford v. Lopez came as part of a short list of cases from the court’s “long conference” on Monday, at which they considered all of the petitions that became ripe for review during the justices’ summer recess.
    • “In addition to the Hawaii case, the justices added four other new cases – on topics ranging from Cuba’s liability for its confiscation of property in that country in the 1960s to the Fifth Amendment’s takings clause – to the list of cases in which it will hear oral arguments during the 2025-26 term.”
  • Beckers Payer Issues points out,
    • “A federal judge in Massachusetts denied a bid by a coalition of 21 Democratic-led states to halt new ACA rules they argue will impose significant barriers to receiving health coverage.
    • “The lawsuit was filed in July challenging a final rule that CMS introduced earlier this year to amend ACA marketplace regulations, which the states argued will lead to millions of people losing access to health insurance, raise costs for states, and reduce the availability of essential health benefits.”
  • Modern Healthcare adds,
    • “The [District of Massachusetts] decision also sets the stage for a potential larger legal battle if various courts reach differing decisions on the rule’s implementation. The regulation was partially stayed across the country in August as part of a separate case out of the U.S. District Court for the District of Maryland, meaning several provisions in the rule aren’t in effect despite the latest ruling.” * * *
    • “Katie Keith, a director of the Center for Health Policy and the Law at the Georgetown University Law Center’s O’Neill Institute for National and Global Health Law, said the Maryland injunction keeps the same provisions being challenged in Massachusetts from kicking in. That includes a minimum $5 monthly premium for those automatically re-enrolled into fully subsidized health plans and new income verification requirements.
    • “It’s like the rule never went into effect,” Keith said.
    • “But if the attorneys general appeal, their case would head to the 1st U.S. Circuit Court of Appeals, Keith said. That could potentially set up differing rulings on the same regulation, known as a circuit split, since an appeal is pending at the 4th U.S. Circuit Court of Appeals in the Maryland case.”

From the public health and medical / Rx research front,

  • Health Day informs us,
    • “Cardiovascular diseases (CVDs) were the leading cause of disability-adjusted life-years (DALYs) and deaths in 2023, according to a study published online Sept. 24 in the Journal of the American College of Cardiology.
    • “Gregory A. Roth, M.D., M.PH., from the University of Washington in Seattle, and researchers from the Global Burden of Cardiovascular Diseases and Risks 2023 Collaborators described the global, regional, and national burden of CVDs and risk factors including 18 subdiseases and 12 associated modifiable risk factors in 1990 to 2023 in 204 countries and territories.” * * *
    • “Our analysis shows wide geographic differences in CVD burden that can’t be explained by income level alone,” Roth said in a statement. “Given this kind of variation, our findings offer the opportunity to tailor local health policies to target the most relevant risks for specific populations.”
  • The Wall Street Journal explains why it is so important for infants to receive the Hepatitis B vaccine at birth.
    • “It’s the first and only shot most U.S. babies receive: the hepatitis B vaccine—a constant for decades in U.S. newborn care that doctors say is responsible for virtually eliminating childhood cases of the disease.
    • “Now that routine protection could be at risk as the Trump administration considers delaying the shot, the latest in a string of moves that undercut longstanding vaccine recommendations. The president recently quipped that perhaps the vaccine could be delayed until as late as age 12.
    • “Say what? Doctors warn that even delaying the vaccine by a few months would lead to more childhood cases and, ultimately, deaths.”
  • The University of Minnesota’s CIDRAP informs us,
    • “A new study in npj Dementia using data from the UK Biobank shows that COVID-19 survivors aged 50 and older had a higher likelihood of developing new-onset dementia (NOD) compared to uninfected controls. 
    • “A total of 54,757 participants met the inclusion criteria for the study, including 16,017 with COVID-19 and 38,740 non-COVID participants. The median observation period was 24.1 months.
    • “According to the authors, compared with matched non-COVID controls, prior COVID-19 infection was associated with a 41% increased risk of all-cause dementia (hazard ratio [HR], 1.41; 95% confidence interval [CI], 1.13 to 1.75). Men, unvaccinated participants, those with high blood pressure, and those with frequent alcohol use had the highest association with NOD.”
  • Per MedPage Today,
    • “A decline in maternal smoking in the U.S. corresponded with a decline in infants born with gastroschisis, researchers found.
    • “In an examination of more than 25 million live births, maternal smoking fell from about 9.5% in 2017 to about 4% in 2023, and concurrently, the incidence of gastroschisis, a birth defect in which organs are outside the body, dropped from about 2.5 to about 1.5 per 10,000 births, reported Zane Hellmann, MD, MHS, of Yale University in New Haven, Connecticut.
    • “Mothers who had any history of smoking within 3 months of conception were significantly more likely to have a baby with gastroschisis, at a rate of 5.0 per 10,000 births — a nearly 3-fold increase compared to mothers without a history of smoking, at a rate of 1.75 per 10,000 births, Hellmann noted in a presentation during the American Academy of Pediatrics annual meeting.
    • “I think that this highlights the effects that national public health can have on the general population [and] on future generations,” Hellmann said.”
  • Per Medscape,
    • In adults with obesity who achieve ≥ 5% weight loss on a low-calorie diet, a 1-year exercise program produces a greater increase in late-phase postprandial GLP-1 response compared with usual activity, a change that may help curb appetite and prevent weight regain.
  • and
    • The benefits of omega-3 fatty acids (FAs) are well known to medical professionals, but your patients may not be as well versed on their benefits or where to find them or how to add them to their diets. [The article shares] some tips to help explain omega-3 FAs.

From the U.S. healthcare business front,

  • Kaufman Hall considers “Rethinking payer-provider relationships after the One Big Beautiful Bill: Where will the money come from?”
  • Per MedPage Today,
    • “With all the changes to the healthcare sector — from vaccine recommendations to efforts to crack down on pharmacy benefit managers — how are health insurers responding? 
    • ‘MedPage Today Washington Editor Joyce Frieden talked with Paul Markovich, CEO of Ascendiun, a healthcare company based in California, about how his company — which includes Blue Shield of California — is meeting the challenges.“
  • The University of Minnesota’s CIDRAP alerts us,
    • “Direct mailing human papillomavirus (HPV) self-testing kits to women’s homes was cost-effective for those who regularly undergo cervical cancer screening, those overdue for screening, and those with unknown screening histories who opted in, per a Kaiser Permanente–led study published today in JAMA Network Open.
    • “The cost-effectiveness and budget-impact analysis was based on the results of a randomized clinical trial conducted from November 2020 to July 2022. The test-delivery costs of Kaiser Permanente Washington and Medicare included wellness-based or screening-only visits. The 31,355 participants, aged 30 to 64 years, were identified through electronic medical records (EHRs).
    • “Regularly screened participants were randomly assigned to usual care (UC), education (UC and mailed educational materials), direct mail (UC, education, and mailed self-sampling kit), or opt-in (UC, education, and mailed invitation to request kit). 
    • “Participants overdue for screening were assigned to UC, education, or direct mail. Those with an unknown screening history were assigned to UC, education, or opt-in.
    • “Home-based testing addresses well-documented screening barriers and can mitigate the impact of appointment backlogs and scheduling constraints on patients and health care systems,” the study authors wrote. “However, cost-effectiveness has not been evaluated across other screening histories.” * * *
    • “In this economic analysis of a randomized clinical trial, directly mailing HPV kits to individuals who were screening adherent and overdue for screening was economically dominant over other strategies,” the researchers wrote. “Program costs declined rapidly over 4 years. Results support directly mailing HPV kits to eligible individuals as an effective, efficient, and affordable outreach strategy.”