“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From Washington, DC

• It’s a national election day. More tomorrow.

• Beckers Payer Issues reports,
  • “Medicare beneficiaries in 193 counties across 16 states will have no Medicare Advantage prescription drug plans available for general enrollment in 2027, up from 123 counties in 2026, according to an Oct. 9 KFF analysis of CMS plan landscape data.” 
    
• The American Hospital Association News relates,
  • “The Administration for Strategic Preparedness and Response announced Nov. 3 that it will partner with the Bureau of Industry and Security and the Assistant Secretary of Defense for Health Affairs on an assessment of U.S. pharmaceutical key starting materials in an effort to identify supply chain vulnerabilities and strategies to improve domestic manufacturing capabilities. The assessment would examine supply chain elements of U.S. pharmaceutical manufacturing efforts, including domestic production capacity and the country’s reliance on foreign or single sources of critical materials.”

• Bloomberg Law tells us,
  • “A forthcoming proposed rule will expand employers’ ability to help workers pay for health insurance in the individual market, boosting the one major surviving insurance policy from President Donald Trump’s first term.
  • “Trump first created independent coverage health reimbursement arrangements in 2019, and they’ve now been rebranded as custom health option and individual care expense, or CHOICE arrangements. The policy allows employers to contribute money tax-free to pay for health expenses, including insurance premiums in the individual market.
  • “CHOICE is Trump’s least controversial insurance plan with Democrats, in part because it helps strengthen the Affordable Care Act exchanges by increasing enrollment in the individual market — even though most CHOICE plans are purchased off-exchange. Backers say small employers can offer benefits they couldn’t otherwise afford, while critics question whether employees are better off under individual market plans than traditional employer-sponsored plans.”

From the U.S. Food and Drug Administration front,

• Beckers Hospital Review reports,
  • “Macleods Pharma USA has recalled 3,744 bottles of a combination blood pressure medication nationwide after the product failed dissolution specifications, according to an FDA enforcement report.
  • “The voluntary recall covers olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 milligrams/10 milligrams/12.5 milligrams, in two lots: 3,528 30-count bottles (NDC 33342-246-07, lot 12251163A) and 216 90-count bottles (NDC 33342-246-10, lot 12251163B), both expiring May 31, 2027. The company, which notified consignees by letter, initiated the recall Oct. 7. The FDA classified it as Class II on Oct. 26, and the recall is ongoing.”
• and
  • “The FDA has approved Novo Nordisk’s Awiqli as the first once-weekly, long-acting basal insulin for children 10 years and older with Type 2 diabetes.
  • “Awiqli (insulin icodec-abae) injection, 700 units/milliliter, was approved as an adjunct to diet and exercise to improve glycemic control, according to an Oct. 23 news release from Novo Nordisk. The treatment reduces basal insulin injection frequency from seven times per week to one.
  • “The approval was supported by evidence from studies in adults with Type 2 diabetes and a single-dose pharmacokinetic study in pediatric patients ages 10 to 17. Efficacy and safety were also demonstrated in the ONWARDS clinical trial program.
  • “Awiqli is available at more than 70,000 pharmacies nationwide.”

• BioPharma Dive adds,
  • “Vertex, ahead of FDA decision, calms fears surrounding kidney drug
    • “On a conference call, executives expressed conviction in the coming launch of an IgA nephropathy medicine viewed by Wall Street investors as important to its future.”

From the public health and medical / Rx research front,

• The New York Times reports,
  • “A 7-month-old, unvaccinated child in New York’s North Country died after contracting measles, the first death in the state from the viral disease in 30 years, officials announced.
  • “Gov. Kathy Hochul said on Monday that the death was a signal that public health protections were eroding as a growing number of families forgo vaccinations.
  • “The child died in Lewis County, which is northeast of Syracuse and has recorded 15 measles cases this year, according to the health authorities, who shared few details about the case. New York is in the midst of a significant measles outbreak. Amish communities, where vaccination rates tend to be lower, have been particularly hard hit.”

• Per Beckers Hospital Review,
  • “States with heavier chronic disease burdens tend to report somewhat lower rates of skipped checkups, according to a Becker’s analysis of three new KFF datasets. Chronic conditions typically require regular physician visits, which likely keeps patients connected to routine care. 
  • “However, 14 jurisdictions break that pattern: seven with high rates on both measures and seven with low rates on both.
  • “Arkansas, Ohio, Wyoming, Oregon, Wisconsin, Montana and Oklahoma reported above-median rates of chronic disease among working-age adults in 2025 and above-median rates of adults skipping a routine checkup — a sign that preventive care may not be reaching people in states where need is high.”
• and
  • “Patients who could not tolerate semaglutide or tirzepatide, or who lost little weight on them, lost substantial weight after bariatric surgery, according to a Cleveland Clinic study published Nov. 3 in Annals of Surgery.”

• Cardiovascular Business relates,
  • “GLP-1 medications such as semaglutide and tirzepatide may outperform metformin in patients with prediabetes, according to new data being presented at the American Heart Association’s Scientific Sessions 2026 in Chicago. 
  • “Metformin is typically the therapy of choice for patients with prediabetes, but GLP-1 drugs appear to be better at preventing type 2 diabetes while also reducing the risk of heart attack and stroke.
  • “The great news with prediabetes is that it’s still possible to reverse the progression of the disease,” co-author Vinicius de Sousa Barzon Serra, MD, a research fellow in the department of cardiovascular medicine at the Mayo Clinic in Scottsdale, Arizona, said in a statement ahead of the conference. “This research may add to the case for considering GLP-1 medications earlier for certain patients, rather than waiting until they develop type 2 diabetes.”
  • “This study included data from more than 250,000 adult patients with prediabetes and obesity. The mean age was 52 years old, and 72% were women. Participants were followed for approximately three years. Overall, approximately half of these patients were on GLP-1 drugs such as semaglutide, tirzepatide, liraglutide or dulaglutide. The remaining patients were taking metformin.”
• and
  • “Cannabis use is associated with a heightened risk of cardiovascular disease (CVD), according to new data being presented at the American Heart Association’s Scientific Sessions 2026 in Chicago.
  • “Researchers tracked data from more than 440,000 American adults who responded to telephone interview questions about cannabis use. These interviews were conducted as part of the Behavioral Risk Factor Surveillance System. 
  • “Overall, the group found that using cannabis one to five days per month was linked to a 23% higher odds of reporting a history of CVD. These low-frequency users also had a 40% higher odds of experiencing a stroke. Heavy cannabis users, meanwhile, were associated with a 23% higher odds of reporting a history of CVD and a 25% higher odds of experiencing a stroke.
  • “When it came to heart attack risk, on the other hand, the study’s authors did not identify any comparable trends.
  • “We were surprised to find that the link between cannabis use and cardiovascular disease was not straightforward,” study co-author Aabha Divya, MBBS, MCh, an assistant professor of cardiothoracic surgery at the Tulane University School of Medicine, said in a statement ahead of the conference. “We expected that the chances of heart disease would gradually rise as people used cannabis more often, but that wasn’t the case. Both low-use and heavy-use groups had higher odds of developing heart disease.”

• Per a Census Bureau news release,
  • “As the U.S. population age 65 and older grew from 2008 to 2025, so did the number of older adults with a disability.
  • “But while the number of older Americans with a disability climbed 38.0% to 21.7 million, the overall share actually dipped 7.0 percentage points, from 40.5% to 33.5% during the same period, according to newly released 2025 American Community Survey (ACS) 1-year estimates.
  • “The decline was particularly pronounced among women and adults with less than a high school education.
  • “The drop in the percentage of older adults with a disability is a promising public health trend. But the increase (66.9%) in the share of the total population 65 and over presents care challenges for families, hospitals and public support programs, particularly for those with chronic health issues and disabilities.”
    
• Bloomberg Law tells us,
  • “People whose long Covid affects multiple body systems are far less likely to improve than overall recovery estimates suggest, with fewer than one in five experiencing sustained improvement within three years of infection, according to a US study.
  • “Researchers followed 1,019 adults who still had probable long Covid a year after their initial infection. About half experienced sustained symptom improvement over the following three years, while roughly a quarter had complete symptom remission, the study, published Monday in Annals of Internal Medicine , found.
  • “But outcomes differed dramatically depending on the pattern of illness. About 60% of people whose long Covid was dominated by changes in smell or taste had improved by three years, compared with less than 19% of those with symptoms affecting multiple body systems.”

• Health Day informs us,
  • “E-bike crashes involving kids are soaring — and the injuries are getting more serious, according to a new study.
  • “We’ve been seeing more and more kids on e-bikes, both on the street and in the hospital,” said co-author Dr. Stephanie Chao of the Stanford University School of Medicine.
  • “Researchers examined more than 13,000 injury cases at six children’s hospitals across the country.
  • “They found e-bike injuries jumped 33% per quarter from early 2023 through March 2026.
  • “E-scooter injuries rose 15% per quarter. In all, 8% of e-bike injuries were classified as severe — double the rate for traditional bikes.
• and
  • “Parental autoimmune diseases were associated with a higher risk of type 1 diabetes in offspring.
  • “Risk grew substantially when either mothers or fathers had type 1 diabetes.
  • “The study did not account for disease severity, autoantibody levels, disease activity during pregnancy, or medication use.”

• Medscape points out,
  • “A year after completing treatment for obesity, adolescents trained in regulating their emotions were significantly more likely to sustain their weight loss than peers who received standard behavioral therapy alone, according to a randomized clinical trial published in JAMA Network Open.
  • “Those who learned the add-on skills also reported significantly less emotional eating at follow-up compared with those who went through just the diet and exercise program.
  • “Emotional eating is one of the triggers for overeating and binge eating for many — over time, the goal is for teens to see food as one of many ways to feel better, but not the only one,” said Kerri Boutelle, PhD, professor of pediatrics and psychiatry at the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego, who led the study.”

• Healio adds,
  • “A low-carbohydrate, ketogenic diet was found to have the most benefits for liver health vs. other diets.
  • “The keto diet also appeared to be most effective at improving blood sugar control.”

• Per an Institute for Clinical and Economic Review news release,
  • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of tavapadon (Juvmo^TM, AbbVie Inc.) for Parkinson’s disease.
  • “ICER’s report on this therapy was the subject of the October 2026 public meeting of the CTAF, one of ICER’s three independent evidence appraisal committees that discusses and votes on ICER’s report findings. Currently available evidence indicates that tavapadon provides some relief from key symptoms. Benefits from tavapadon appear to be similar to those of older, generic drugs, however, and discontinuation from tavapadon due to adverse events was relatively high.
  • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • “Tavapadon provides a net health benefit over no additional pharmacological treatment, but there are open questions about its benefits compare to other available symptomatic treatments,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “Unfortunately, the manufacturer chose a price for tavapadon far above any reasonable estimate of a value-based price. This may lead payers to implement formulary restrictions to limit provider and patient access to this new treatment.”

From the U.S. healthcare business front,

• The Wall Street Journal reports,
  • “CVS Health will split into two companies, dividing its retail pharmacies from its insurance and pharmacy-benefit operations in a move that will reverse one of the signature deals defining an era of health-industry gigantism, the company said.
  • “The breakup is set to occur in the first half of 2028, a decade after the transformative nearly-$70 billion acquisition that knit together insurance giant Aetna with CVS’s namesake drugstores, its pharmacy-benefit manager Caremark and other assets. 
  • “The two resulting companies will both be publicly traded, and current CVS shareholders will own shares in both. The Financial Times earlier on Tuesday reported the breakup.
  • “One of the two new firms will keep the CVS Health name, and will be run by David Joyner, who is chief executive of today’s CVS, the company said. 
  • “In addition to the insurance and PBM assets, that company will include senior-focused clinics business Oak Street Health, the home-visit provider Signify Health, and CVS’s specialty-drug business, a key growth lever.”
• and
  • “Pfizer boosted its guidance for the year, as momentum in new products helped it offset declining sales for its Covid-19 vaccine and treatments.
  • “The New York company said Tuesday that sales for its recently launched and acquired products—which include cancer treatments Padcev and Lorbrena—gained 32% in the latest quarter. Higher sales for other products, like blood thinner Eliquis and heart-disease treatment Vyndaqel, also boosted the company’s top line.
  • “Sales of Covid products like Paxlovid and Comirnaty, meanwhile, continued to slide.”

• Fierce Healthcare relates,
  • “Hinge Health is seeing early traction with its migraine and gastrointestinal care programs as it pushes beyond musculoskeletal care and builds a broader, multi-condition platform.
  • “But the company’s core MSK business remains the engine fueling its robust growth. 
  • “Our vision has always been to automate the delivery of care using technology to close the gap between the care people need and the care they actually receive. We’re now applying that same approach and the same trusted relationships with employers and partners in neurology and gastrointestinal care,” Daniel Perez, Hinge Health co-founder and CEO, told analysts and investors on the third-quarter earnings call Monday. “We’re not starting from scratch in each new category. We’re extending a platform that’s already proven into conditions that are often connected to the ones we already treat. We believe that’s a fundamentally different and more powerful way to expand than what other companies in our space are attempting.”
• and
  • “Humana and athenahealth are expanding electronic prior authorizations nationwide in a newly announced collaboration. 
  • “Through athenaPayer, Humana is able to connect with over 180,000 providers across the athenaOne network, which the partners said will create a more connected experience between the health plan and clinicians.” 

• Beckers Clinical Leadership tells us,
  • “As AI races into exam rooms and onto patients’ phones, the physician’s role is more important than ever — not because doctors must police the technology, but because chatbots cannot replace trust, judgment and the patient-physician relationship, according to Jan Carney, MD.
  • “Dr. Carney, 2026-2027 president of the American College of Physicians, published a statement Nov. 3 about AI hype. Dr. Carney is associate dean for public health and health policy and chief of the division of public health at the University of Vermont’s medical college in Burlington, Vt.
  • “Her message follows a September MAHA summit wherein HHS Secretary Robert F. Kennedy Jr. said AI can offer “a second opinion that is much better informed than any doctor in the country” — a claim six physician organizations, including ACP, publicly refuted. Those groups said physicians must “help lead the responsible development and use of AI in medicine.”

• Beckers Health IT adds,
  • “Health systems have spent the past few years building the case for AI one use case at a time. Less clear is what AI will do to the nation’s healthcare bill.
  • “It came up during the opening keynote at Becker’s 11th Annual IT + Revenue Cycle Conference in Chicago, where Bobbie Byrne, MD, executive vice president and CIO of Charlotte, N.C.-based Advocate Health, gave an answer that rarely shows up in an AI vendor’s pitch deck.
  • “I do think … AI in general is going to raise the cost of healthcare, not for our organization, but in total,” Dr. Byrne said at the September event. “We’ve talked about how we’re using AI to improve care. Well, care is what? Cost.”
  • “The research cuts both ways. A 2023 National Bureau of Economic Research working paper estimated that wider AI adoption could save 5% to 10% of U.S. healthcare spending. A September Blue Cross Blue Shield Association white paper pegged the cost of rising hospital coding intensity at about $942 million over two years and linked it to the spread of AI-assisted billing tools, findings the American Hospital Association challenged in October. Health system CIOs are also working to rein in usage-based AI token costs that grow as adoption does.”

• MedTech Dive informs us,
  • “Bracco is investing $230 million to construct its first U.S. manufacturing facility for injectable contrast media, the company said last week. 
  • “Bracco will build the facility in Sanford, North Carolina. The company expects to create 200 jobs and could receive a $2.9 million grant over 12 years. 
  • “Adding U.S. production capacity could enhance the resilience of the supply chain, which failed to meet demand for iodinated contrast media during a pandemic-related lockdown in 2022.”