Midweek update

Mental health care

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Politico reports,
    • “Republicans say they are close to finalizing a package of full-year funding measures for select federal agencies — a critical piece of bipartisan negotiations over the terms for ending the prolonged government shutdown.
    • “The mini-package should be nearing completion, and that will be the vehicle” for the stopgap spending bill to reopen the government, Senate Majority Leader John Thune said Wednesday after a closed-door GOP lunch.
    • “Thune met Tuesday night with Democratic negotiators on the shutdown, including Sen. Jeanne Shaheen of New Hampshire and Sen. Angus King (I-Maine), who caucuses with Democrats. Bipartisan negotiators want the Senate to stay in session through the weekend to finish a deal, according to two people granted anonymity to disclose private dynamics. 
    • “While Thune didn’t rule out staying past the Senate’s normal Thursday afternoon exit time, he said he’d need to first see how much progress was being made.”
  • The Wall Street Journal reports,
    • “The Federal Aviation Administration said it was ordering airline traffic to be reduced by 10% at 40 airports while air-traffic controllers work without pay during the government shutdown.
    • “Transportation Secretary Sean Duffy said starting Friday, the reduction would help keep air travel safe as flight delays and cancellations pile up. The shutdown, which began Oct. 1, has exacerbated staffing issues in the ranks of federal transportation employees, leading to flight delays and long lines at security checkpoints. 
    • “This is about where’s the pressure and how do we alleviate the pressure,” Duffy said Wednesday at a news briefing.”
  • Per an OPM news release,
    • “The U.S. Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) today released new guidance to federal agencies on how to implement President Donald Trump’s Executive Order 14356, Ensuring Continued Accountability in Federal Hiring. In his first year in office, President Trump met and exceeded the ratio of four employee departures for each new hire, this guidance directs agencies on how to ensure federal hiring remains cost-effective, mission-focused, and aligned with administration priorities.
    • “This is about ensuring government works better for the American people,” OPM Director Scott Kupor said. “We’re bringing accountability and discipline to every hiring decision, making sure agencies are staffing for mission need, not bureaucratic habit.” * * *
    • “Read the memo here and Director Kupor’s blog on this here.”
  • Federal News Network points out,
    • “As Open Season approaches, one Republican is raising concerns about funding for the Federal Employees Health Benefits program. Sen. James Lankford (R-Okla.) is questioning the Office of Personnel Management on how it plans to avoid exhausting the FEHB’s trust fund. He said it’s a concern, since there aren’t any incoming contributions to the trust fund under the government shutdown. In response to Lankford’s questions, OPM said that if needed, it would be able to let health carriers request additional funding from contingency reserves. But for the time being, OPM said all FEHB plans have sufficient funds to pay claims.(Letter to OPM on FEHB program under shutdown – Sen. James Lankford (R-Okla.))”
  • and
    • “The Office of Personnel Management is hinting at some upcoming tech hiring initiatives. The specific timeline for launching the OPM initiatives is unclear, and many details of the tech hiring efforts are still in the works. But agencies should be focused on tech recruitment, particularly in artificial intelligence, according to OPM Director Scott Kupor. “I think the thing that government has to do is not be the last dinosaur. If we do that, there’s no amount of organizational structure or marketing or anything else that’s going to save us, we have to be willing to embrace these things,” Kupor said at a NAPA conference on Monday. (OPM’s Kupor wants more tech expertise in the federal workforce – Federal News Network)”

From the judicial front,

  • Per Fierce Biotech,
    • “Amid the rapidly unfolding saga revolving around Metsera, a judge has denied Pfizer’s request to block Novo Nordisk’s buyout bid for the biotech, Bloomberg reports.
    • Delaware Chancery Judge Morgan Zurn has refused to deliver a Pfizer-requested temporary restraining order, saying the pharma’s objections to the proposed deal weren’t a legitimate reason for stopping Novo’s offer, according to the publication.” * * *
    • “Meanwhile, Pfizer has said it remains “confident” in the merits of its claims and its belief that Metsera is breaching its contractual obligations.
    • “Today’s decision does not address the merits of the underlying legal issues raised, and Pfizer intends to continue to pursue its claims vigorously through the ongoing litigation process as well as in its parallel antitrust litigation pending in Delaware federal court,” the pharma said in a Nov. 5 statement in response to the ruling.”
  • STAT News reports,
    • “The Federal Trade Commission has raised concerns about Novo Nordisk’s attempt to outbid Pfizer to acquire obesity startup Metsera, the latest complication in a dramatic bidding war between two pharma giants.
    • “Companies normally have to seek FTC review for acquisitions under a law called the Hart-Scott-Rodino Premerger (HSR) Notification Act. The companies must wait a prescribed amount of time after the filings are submitted before concluding their transaction.
    • “Novo’s deal is structured so that it would first pay a large amount to acquire half of Metsera’s stock. If Novo does that before seeking regulators’ review, then it may violate the act, Daniel Guarnera, director of the bureau of competition at the FTC, wrote in a letter sent Tuesday to lawyers of Novo and Metsera.”

From the public health and medical / Rx research front,

  • The American Hospital Association News tells us,
    • “There have been 1,681 confirmed cases of measles in the U.S. so far this year, according to the latest Centers for Disease Control and Prevention data. Cases have been reported by 42 states and jurisdictions, and 12% of cases have been hospitalized. There have been 44 reported outbreaks, and 87% of all cases are outbreak-associated. The vaccination status of 92% of all confirmed cases is classified as “unvaccinated or unknown.” 
  • and
    • “An AHA blog examines how the Cleveland Clinic’s food-as-medicine strategy reaches far beyond clinical care by using a multi-angle approach to food access and nutrition. READ MORE” 
  • Health Day informs us,
    • “Tobacco remains the leading preventable cause of cancer death in the U.S., despite a dramatic decline in smoking, a new American Cancer Society report says.
    • “More than 80% of lung cancer deaths are linked to tobacco, according to data from the inaugural release of the American Heart Association’s U.S. Tobacco Atlas.
    • “That’s even though cigarette smoking among adults cratered from 42% in 1965 to just 11% in 2023, researchers said.
    • “Quit rates also have skyrocketed, with a record 62% of smokers trying to drop the habit in 2022, the reports say.
    • “However, smokers are shunning the low-dose CT chest scans that are recommended for lung cancer screening, results show.
    • “Only 18% of eligible current or former smokers were up to date with screening in 2022 — such screening can catch cancers early and improve survival odds.”
  • MedPage Today adds,
    • “Though the percentage of U.S. teenagers who vape nicotine has declined in recent years, daily vaping among those already doing so increased, as did unsuccessful quit attempts, a cross-sectional study suggested.
    • “In a pooled sample of more than 115,000 respondents from the Monitoring the Futureopens in a new tab or window survey, prevalence of past-30-day nicotine vaping declined from 17.8% in 2020 to 10.1% in 2024 (RR 0.88, 95% CI 0.86-0.89), reported Abbey Masonbrink, MD, MPH, of the Keck School of Medicine at the University of Southern California in Los Angeles, and colleagues.
    • “However, among more than 15,000 respondents who currently vape, prevalence of daily vaping increased from 15.4% in 2020 to 28.8% in 2024 (RR 1.14, 95%CI 1.11-1.18), they reported in JAMA Network Openopens in a new tab or window. And among more than 3,500 daily vapers, prevalence of unsuccessful quit attempts rose from 28.2% in 2020 to 53% in 2024 (RR 1.08, 95%CI 1.02-1.15).
    • “Despite recent trends in decreasing overall prevalence of nicotine vaping in youth, our research team was concerned about the potential for increasing hardening among current youth users,” Masonbrink told MedPage Today in an email. “As recently evolving nicotine vaping products allow for higher nicotine exposure and known treatment barriers for youth, we wanted to assess for increasing frequency of use and nicotine dependence in this population.”
    • “Ultimately, the study found a “concerning recent trend of increasing trends in daily use among youth who are current users by nearly double and increasing inability to successfully quit, a marker of nicotine dependence, in this population,” she said.”
  • The Wall Street Journal offers advice from Team USA’s doctor on how to avoid becoming ill during air travel.
  • The Washington Post discusses prospects for an experimental pancreatic cancer treatment pill.
    • “Based on early clinical trial results, the Food and Drug Administration in October awarded the drug’s sponsor, biotech company Revolution Medicines, a new and unconventional accelerated review designed to get promising drugs to patients faster than ever. The pancreatic cancer drug, and other medications selected under the “Commissioner’s National Priority Voucher” initiative, will test whether it can expedite novel treatments without compromising the rigor of agency reviews, experts say.” * * *
    • “The FDA’s selection of Revolution Medicines’ daraxonrasib appeared to cement its status as one of the most promising experimental cancer drugs. It also is being studied for treating lung and colorectal cancer.
    • One of the company’s first clinical trials gave daraxonrasib to 83 patients whose pancreatic cancer had spread after undergoing at least one earlier intervention, such as chemotherapy. Over more than 16 months, at least 29 percent of the participants saw their tumors shrink while more than 90 percent saw no tumor growth. The median overall survival was 15.6 months, according to the results, which by some measures is about twice as long as such patients typically fare with standard treatments. Results of its first major, randomized trial, with about 460 patients, are expected next year.”
  • Medscape adds,
    • “A blood-based biomarker test, PancreaSure, demonstrated high sensitivity and specificity in differentiating patients with early-stage pancreatic ductal adenocarcinoma (PDAC) from control individuals at high risk. The test outperformed CA19-9 alone, showing higher sensitivity across two independent clinical validation studies.”
  • Cancer Therapy Advisor notes,
    • “Beginning statin therapy within 36 months of breast cancer diagnosis is linked to improved survival for patients with early-stage disease, compared to patients who do not use statins, according to research published in JAMA Network Open.
    • “These findings highlight the potential of statins as an adjunctive therapy in [breast cancer] treatment, offering a promising avenue for enhancing clinical outcomes,” study researchers wrote.”
  • Per MedPage Today,
    • “Moderate to severe obstructive sleep apnea (OSA) independently correlated with development of cerebral microbleeds seen on brain MRI.
    • “Cerebral microbleeds are considered an early marker of cerebral vasculopathy and are associated with increased risk of developing symptomatic stroke and dementia.
    • “Moderate to severe OSA should be a potential target for early diagnosis and treatment to potentially prevent future strokes and dementia in aging populations, although the study did not assess those outcomes.”
  • and
    • “Survival rates of people with young-onset dementia — dementia diagnosed before age 65 — varied considerably by clinical type, a population-based cohort study in Finland showed.
    • “The median survival for young-onset dementia (also known as early-onset dementia) was 8.7 years, said Eino Solje, MD, PhD, of the University of Eastern Finland in Kuopio, and co-authors.
    • “The shortest survival was seen in people with young-onset frontotemporal dementia (6.9 years) or alpha-synucleinopathy (7.0 years). The longest survival was seen in people with young-onset Alzheimer’s disease (9.9 years) and those with mixed or other dementias (more than 10 years).”
  • Beckers Hospital Review identifies “14 recent drug shortages and discontinuations, according to FDA drug supply databases.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana is convinced that it can grow both the size and profitability of its Medicare Advantage business in 2026, despite concerns that the insurer’s plans are too generous and could saddle the company with undesired costs.
    • ‘Executives said they’re confident in their plan pricing and design on a call to discuss Humana’s third quarter results Wednesday morning — though, they noted there are steps Humana can take to manage membership growth if it starts looking like it may get out of hand as open enrollment continues.
    • “Humana said it’s still on track to double pre-tax margins in the privatized Medicare plans next year compared to 2025. But that forecast excludes the impact of quality or “star” ratings. The number of Humana members in highly rated plans dropped for 2026, complicating its path to profit recovery during a difficult time for payers in government programs.”
  • and
    • “Amwell is considering divesting some non-core assets as the telehealth vendor looks to narrow its business focus and improve financial performance, executives said on a third quarter earnings call Tuesday. 
    • “The company is mulling selling legacy assets that could be more easily separated from the rest of the business without creating challenges for customers, executives said. “These are distinct assets that have a certain profile of clients that we could, in fact, cordon off,” said Amwell CFO and COO Mark Hirschhorn.
    • “Amwell already sold its virtual psychiatric care business to fellow telehealth provider Avel eCare for about $21 million early this year.” 
  • and
    • “The fate of bankrupt Prospect Medical Holdings’ two Rhode Island hospitals hangs in a precarious balance this week, as the health system and the state’s attorney general clash in court over Prospect’s desire to close the facilities by year end. 
    • “Prospect sought court approval to close the two safety-net hospitals on Thursday, saying in court documents that the facilities are losing millions each month and that sale conditions imposed by state regulators make a deal untenable.
    • “The Centurion Foundation, the hospitals’ proposed buyer, and attorney general Peter Neronha opposed the motion in their own filings on Monday. Neronha warned closures would be “catastrophic” for patients.”
  • Fierce Healthcare relates,
    • “Hinge Health wrapped up another strong quarter—its second as a public company—as its results beat Wall Street expectations and the company boosted its 2025 outlook.
    • “The virtual physical therapy company, which went public in late May, brought in third-quarter revenue of $154 million, up 53% from the same period a year ago. Wall Street analysts expected revenue of $142 million.
    • “Hinge’s third-quarter revenue performance exceeded the high end of its guidance range of $141 million to $143 million “due to strong billings performance stemming from the continued strength of the company’s underlying fundamentals,” the company’s chief financial officer James Budge told investors and analysts on the company’s third-quarter earnings call Tuesday.”
  • and
    • “Medicare Advantage (MA)-focused insurtech Clover Health saw its revenue climb by 50% year over year in the third quarter, per its earnings report released late Tuesday.
    • “Clover reported $496.6 million in total revenue for the quarter, up from $331 million in the third quarter of 2024. Through the first nine months of the year, revenues were $1.4 billion, compared to the company’s haul of $1 billion through the first three quarters of 2024.
    • “The company also posted a $24.4 million net loss in the quarter, with its losses increasing from $9.2 million in the prior-year quarter. Clover has reported $36.2 million in losses through the first three quarters of the year, up from $20.9 million in losses a year ago.
    • “The company reported $2 million in earnings before interest, taxes, depreciation and amortization.
    • “Our model of care continues to perform well as we bring our technology-powered care to more Medicare Advantage seniors,” said Clover Health CEO Andrew Toy in the earnings release.”
  • and
    • “Carrum Health launched a substance use disorder treatment program for employers a year ago and has now expanded it to include cannabis, cocaine and methamphetamine as employer demand surges.
    • “It’s estimated that 29 million U.S. employees—1 in 6 working adults—are struggling with substance use disorder. Approximately 6.5% of full-time U.S. employees met the criteria for a cannabis use disorder in a 2021-22 study. Another study found that workplace cannabis consumption was highest among workers in states with “recreational” cannabis laws.
    • “This poses a major health challenge for employers, and there’s a critical unmet need for cost-effective prevention and treatment strategies.”
  • The American Journal of Managed Care tells us,
    • “Adequate outpatient follow-up within 30 days significantly reduces 30-day all-cause hospital readmissions, impacting hospital finances and patient care quality.
    • “The study analyzed 83 studies, primarily US-based, showing reduced readmission risks for heart failure and acute myocardial infarction with timely follow-up.
    • “Heterogeneity in study designs and US-centric data limit the generalizability of findings to other health systems.
    • “Authors emphasize considering patient-specific risk factors in prioritizing post-discharge follow-up to optimize outcomes.”
  • Per BioPharma Dive,
    • Novo Nordisk reined in expectations for full-year sales and profit amid expected price cuts and a disappointing third quarter for its obesity drug Wegovy.
    • The Danish drugmaker now expects sales growth of 8% to 11% for the year after previously predicting revenue might expand by as much as 14%. Operating profit will likely grow between 4% and 7%, down from an estimate of as much as 10%, Novo said Wednesday, a shift executives attributed on a conference call to “intensifying competition and pricing pressure.”
    • Sales of semaglutide, sold as Wegovy for obesity and Ozempic for diabetes, continued to rise in the third quarter and together brought in more than 51 billion Danish kroner, or about $7.9 billion. But analysts had been looking for more from Wegovy, and the combined total fell short of Eli Lilly’s rival Zepbound/Mounjaro drug, which became the world’s best-selling medicine in the third quarter with more than $10 billion in revenue.
  • Per Fierce Pharma,
    • “Madrigal’s Rezdiffra generated sales of $287 million in the third quarter for a 35% sequential jump from Q2. In just its fifth full quarter on the market, the world’s first treatment for metabolic dysfunction-associated steatohepatitis (MASH) is now annualizing at more than $1 billion.
    • “While the numbers are heady and a second MASH treatment has recently entered the market, Madrigal says there is significant room for growth. Because the disorder is underdiagnosed, the company figures that competition from Novo Nordisk’s GLP-1 Wegovy—which gained an FDA label expansion to treat MASH three months ago—will help increase the patient pool.
    • “We welcome new entrants to this evolving market. Wegovy’s recent approval in MASH adds momentum to a market that’s just starting to take shape,” Madrigal CEO Bill Sibold said on a quarterly conference call. “Novo is targeting a much larger population, which will raise awareness and drive more screening, diagnosis and treatment.”

Monday report

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

From Washington, DC

  • Roll Call reports,
    • “Senate Republican leaders plan to abandon a House-passed funding patch to reopen government and pivot to a new bill that would provide more time to complete fiscal 2026 appropriations.
    • “The move reflects a growing recognition that the funding extension to Nov. 21, as the House proposed in September, would no longer provide enough time to complete appropriations bills for the fiscal year that began Oct. 1. It also comes after Democrats blocked the House measure from advancing in the Senate more than a dozen times.
    • “The idea that we could get any appropriations bills done…by November the 21st now … that date’s lost,” Senate Majority Leader John Thune, R-S.D., told reporters Monday in confirming the new strategy. “The objective here is to try and get something that we could send back to the House that would open up the government.” * * *
    • “Thune said he was optimistic that a deal could emerge to end the shutdown this week, though he was careful to hedge his bets. “If we don’t start seeing some progress, or some evidence of that by at least the middle of this week, it’s hard to see how we would finish anything by the end of the week,” he said.”
  • Sen. James Lankford (R OK) has written to OPM Director Scott Kupor about the impact of the shutdown on the FEHB and PSHB Program.
    • “The Office of Personnel Management’s (OPM) health insurance trust funds are sponsored by federal government employer contributions. With no current incoming contributions due to the ongoing government shutdown, I am concerned that these funds will be exhausted if the lapse in funding continues.”
  • Fair question.  
  • Federal News Network interviews Tammy Flanagan about the upcoming FEHB / PSHB Open Season which begins next Monday.
  • The Internal Revenue Service announced today that “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2025, and before October 1, 2026, is $3.84 [per covered belly button]. This will be the applicable dollar amount that FEHB and PSHB plans will pay on or before July 31, 2026.
  • Modern Healthcare reports,
    • “Nearly three dozen physician specialty groups have called on Congress to halt a new policy that will reduce Medicare payments for thousands of billing codes. 
    • “The Centers for Medicare and Medicaid Services issued a final rule Friday setting Medicare reimbursements to physicians in 2026. Although the regulation grants a 2.5% overall rate increase, it also introduces a “efficiency adjustment” that will trim payments for some specialty services by 2.5%. One of the agency’s stated goals is to increase support for primary care.
    • “But the American College of Surgeons and 33 other medical specialty societies cry foul in a letter sent Monday to House Speaker Mike Johnson (R-La.), House Minority Leader Hakeem Jeffries (D-N.Y.), Senate Majority Leader John Thune (R-S.D.) and Senate Minority Leader Chuck Schumer (D-N.Y.).
    • “We urge you to stop the implementation of this proposal before it begins on January 1, 2026, by using all legislative tools at your disposal,” the organizations wrote in the letter. “This ‘efficiency adjustment’ will cause further decreases in reimbursement for physician services and have wide-ranging consequences, including significant financial pressures that could limit patient access to medical care, particularly for the most vulnerable populations.”
  • Beckers Hospital Review offers 12 notes on this final rule.
  • Avalere Health explains “how stakeholders can engage with the USPSTF recommendation development.

From the Food and Drug Administration front,

  • STAT News reports,
    • “In a major setback, UniQure said Monday that the timing of when it can file its experimental and promising Huntington’s disease treatment for approval with the Food and Drug Administration “is now unclear,” raising the prospect that the biotech may need more data.
    • “In a statement, UniQure said that at a recent meeting with the FDA about the treatment, a gene therapy known as AMT-130, the agency signaled that it “no longer agrees” that existing data from a Phase 1/2 study with an external control group are adequate for an approval submission. The company called it “a key shift from prior communications with the FDA” in multiple meetings over the past year.” 
  • Fierce Pharma tells us,
    • “Roche’s Gazyva is at it again. After an FDA nod in lupus nephritis marked a fresh chapter for the aging blood cancer blockbuster just two weeks ago, the drug is looking to solidify its position as a contender in the lupus treatment landscape with a positive trial result that could support an expansion into the most common type of lupus.
    • “In Roche’s phase 3 Allegory study, the anti-CD20 monoclonal antibody cleared its primary and all secondary endpoints, proving its worth in patients who have systemic lupus erythematosus (SLE) and who are on standard therapy, Roche reported on Monday.”

From the judicial front,

  • Roll Call informs us,
    • “The Trump administration told a federal judge Monday it will deplete what remains of a $6 billion contingency fund to pay a portion of food stamp benefits in November amid the ongoing partial federal government shutdown.
    • “The court filings responded to an order over the weekend from Chief Judge John J. McConnell Jr. of the U.S. District Court for the District of Rhode Island directing the administration to use at least that contingency fund to provide Supplemental Nutrition Assistance Program benefits in November.
    • “The $4.65 billion that remains in the contingency fund would cover about half of the benefits for November, according to a declaration from Patrick Penn, the deputy undersecretary for the USDA’s Food Nutrition and Consumer Services.”
  • The Wall Street Journal reports,
    • “Drugmaker Pfizer PFE has filed a second lawsuit against Metsera MTSR and Novo Nordisk NOVO.B, alleging the weight-loss drug developers’ recent merger agreement would violate federal antitrust laws.
    • “Pfizer alleges that Ozempic maker Novo Nordisk’s proposed acquisition of Metsera would solidify Novo Nordisk’s market position as a leader in the field of obesity drugs by killing off a smaller competitor, according to the lawsuit filed Monday in the U.S. District Court in Delaware.” 
  • MedPage Today points out,
    • The FDA is investigating an outbreak of Salmonella linked to recalled Member’s Mark Super Greens, a dietary supplement powder sold at Sam’s Club; 11 people across seven states have been sickened, including three hospitalizations.
    • And Monarch Premium-branded kratom powder has been recalled over potential Salmonella contamination, the agency said.

From the public health and medical / Rx research front,

  • Health Day reports,
    • “Millions of Americans carry hidden genetic mutations that increase their risk of cancer, regardless of their family’s cancer history, according to a new study.
    • “As many as 5% of Americans, or about 17 million, have genetic variants linked to cancer, researchers recently reported in the Journal of the American Medical Association.
    • “The results suggest these mutations might be more common than previously thought, researchers said.
    • “Genetic testing has traditionally been reserved for individuals with strong family histories or other high-risk indicators,” said senior researcher Dr. Joshua Arbesman, a dermatologist at the Cleveland Clinic.
    • “Our findings show that many people with pathogenic variants fall outside those criteria, suggesting we may be missing opportunities for early detection and prevention,” he continued in a news release. “This research also highlights the importance of regular cancer screenings for all Americans – not just those with a family history or other risk factors.”
  • and
    • “A child’s future risk of depression and anxiety might be tied to their gut health.
    • “Young children whose gut microbiomes contained certain bacteria were more likely to develop a mood disorder as tweens, researchers reported Oct. 30 in the journal Nature Communications.
    • “Researchers discovered that the kids’ gut bacteria were tied to differences in connectivity between emotion-related brain networks – and that those differences, in turn, were linked to anxiety and depression later in childhood.
    • “The results suggest that gut bacteria could play a role in programming a child’s brain circuits, particularly those related to emotion, researchers said.
    • “By linking early-life microbiome patterns with brain connectivity and later symptoms of anxiety and depression, our study provides early evidence that gut microbes could help shape mental health during the critical school-age years,” senior researcher Bridget Callaghan, chair of developmental psychology at UCLA, said in a news release.”
  • The American Medical Association lets us know “what doctors wish patients knew about seasonal affective disorder.”
    • “Seasonal affective disorder is more than just the winter blues. It is a form of depression linked to changing seasons. Two psychiatrists share more.”
  • JAMA Insights notes,
    • “Incretin-based therapies, such as glucagon-like peptide-1 receptor agonists (GLP-1RAs [eg, semaglutide]), which can be combined with gastric inhibitory polypeptide agonists (eg, tirzepatide), are first-line pharmacologic therapies for patients with obesity. Bariatric surgery, commonly referred to as metabolic and bariatric surgery (MBS), is also a highly effective and safe obesity treatment. This JAMA Insights reviews evidence about the efficacy, adverse effects, and optimal approach to combining MBS with medications to treat obesity.”
  • MedPage Today adds,
    • “A large cohort study found three popular GLP-1-based diabetes drugs — semaglutide, dulaglutide, and tirzepatide — carry similar risks for serious adverse GI events, with a rate of about 12 per 1,000 person-years.
    • “The risk of those events was lower with the SGLT-2 inhibitor class of diabetes medications than in the group of GLP-1 drugs.
    • “The authors say the findings should give clinicians confidence that safety differences are not a major factor when choosing among these three GLP-1-related drugs for patients with type 2 diabetes.”
  • Per Healio,
    • “Despite increasing scientific evidence and warnings from public health advocates about the impact of alcohol consumption on cancer risk, public awareness and knowledge of the link remains low.
    • “Nearly two-thirds of U.S. adults either do not believe or do not know that drinking alcohol increases cancer risk, results of a cross-sectional survey study showed.”
  • Optum writing in LinkedIn discusses “pivotal momentum in women’s health benefits.”
  • STAT News reports,
    • “New research bolsters evidence that people with early signs of Alzheimer’s can take steps to slow the devastating neurologic disease — literal steps.
    • “Researchers tracked nearly 300 older adults who had no cognitive impairment at the start of the study, measuring their memory and problem-solving skills, among other abilities, for up to 14 years. They also scanned their brains to monitor the build-up of beta-amyloid and tau, toxic proteins linked to disease progression. 
    • The scientists found that patients who started with high levels of beta-amyloid, an early biological sign of Alzheimer’s, declined less if they were more physically active. Low or moderate levels of physical activity in this group, the authors reported, could slow cognitive decline by half compared with inactive individuals. That effect plateaued at around 5,000 to 7,500 steps a day.
    • “But exercise didn’t slow the buildup of beta-amyloid, the target of current therapies aimed at restraining cognitive loss. Physical activity was instead linked with a slower buildup of tau, which scientists increasingly believe plays a more direct role than amyloid in cell damage and death.
    • “The findings, published in the journal Nature Medicine, build on previous evidence that exercise can delay and slow dementia by proposing a mechanism for this phenomenon: reduced accumulation of tau. The paper also suggests that the oft-cited goal of 10,000 steps a day, which may be difficult to achieve for some older adults, might not be necessary for cognitive benefits.”
  • Genetic Engineering and Biotechnology News relates,
    • “A pioneering technology has been developed that enables human kidney organoids to be produced in a scalable manner by allowing the organoids to be combined with ex vivo pig kidneys and then transplanted back into the same animal to evaluate their viability.
    • “The work is published in Nature Biomedical Engineering, in the paper, “Systematic production of human kidney organoids for transplantation in porcine kidneys during ex vivo machine perfusion.” The findings are a significant milestone in regenerative and personalized medicine, paving the way for the use of kidney organoids derived from human stem cells in cell therapy clinical trials.
    • “Despite the great clinical potential of organoids, one of the major challenges in applying this technology to real medical treatments has been to produce these organoids in a scalable, uniform and affordable way,” says Elena Garreta, PhD, a senior researcher in the IBEC’s Puripotency for Organ Regeneration group. “Now, with our new method, we can generate thousands of kidney organoids under controlled conditions in a short time with great precision, without the need for complex components. This opens the door to applications such as drug screening and disease research.”
  • Beckers Oncology shares seven notes on the ongoing struggle with cancer drug shortages.
  • Per STAT News,
    • “Caribou Biosciences said Monday that its off-the-shelf CAR-T therapy induced complete and durable remissions in patients with advanced B-cell lymphoma.
    • “The study results, while preliminary, are comparable to benchmarks set by currently approved, patient-specific CAR-T therapies for lymphoma — an achievement that could push the off-the-shelf CAR-T field forward after years of setbacks and broaden access to cell therapy for blood cancers.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Kimberly-Clark KMB has agreed to buy Kenvue KVUE for more than $40 billion, combining the maker of Huggies diapers with the owner of Tylenol in one of the biggest takeovers of the year.
    • “In the cash-and-stock deal, Kimberly-Clark will pay $21.01 a share, compared with a closing price of $14.37 on Friday. Kimberly-Clark said the deal, including debt, has a total value of $48.7 billion.
    • “The combination would create a global health-and-wellness company with annual revenues of approximately $32 billion and 10 billion-dollar brands, including Kimberly-Clark’s household staples such as Kleenex tissues and Cottonelle toilet paper and Kenvue’s products such as Tylenol and Listerine mouthwash.
    • “Yet the combined company would face a number of headaches, including President Trump’s warning that Tylenol’s active ingredient is a potential cause of autism.” * * *
    • The companies expect the deal to close in the second half of 2026. The combined company will be led by [Kimberly Clark Mike] Hsu and be based at Kimberly-Clark’s headquarters in Irving, Texas.
  • Fierce Healthcare tells us,
    • “Ascension has opened its 2026 fiscal year with a $133 million improvement on operations and a $337.7 million bottom line, the large Catholic system disclosed Friday.
    • “For the three-month period ended Sept. 30, the nonprofit posted an $87.9 million operating loss (-1.4% operating margin) as opposed to the prior year’s operating loss of $221.3 million (-3.0% operating margin).
    • “The system’s $337.7 million net gain (attributable to controlling interests) was a step back from the $387.1 million of the year before, due to reduced net investment return. Still, the tightened performance drew a stronger 3.4% recurring operating EBITDA margin and optimism from Ascension’s executives.
    • “Our first quarter results show the strength that comes from focusing on our strategy and staying true to our Mission,” Eduardo Conrado, president and CEO-in-waiting, said in a release. “We are managing resources with discipline, investing where it matters most and supporting the teams who care for our patients and communities. When strategy, Mission, investment and talent come together, we build lasting momentum that strengthens our ministry and allows us to serve more people with compassion and excellence.”
  • and
    • “BlackDoctor.org, a health platform that reaches 20 million people, launched a new initiative, Generational Health, that aims to connect science and culture to improve the health and longevity of Black families.
    • “The initiative, unveiled at the 2025 American Public Health Association (APHA) conference in Washington, D.C., on Sunday, represents a sustained national effort to “reimagine how health is understood, taught and passed down,” according to the organization.
    • “Generational Health also aims to expand educational opportunities for historically excluded students to enter healthcare professions.
    • “It marks the beginning of a five-year effort that will use BlackDoctor.org’s 20-year history of providing trusted health information as well as community and cultural engagement as a foundation, and the organization plans to partner with pharmaceutical brands to shape conversations around culturally grounded care, according to Aki Garrett, president and chief operating officer at BlackDoctor Inc.”
  • and
    • “Hippocratic AI has seen rapid growth over the past 18 months, inking partnerships with more than 50 large health systems, payers and pharma clients and building 1,000 use cases for its patient-facing healthcare AI agents.
    • “The company banked a $126 million series C round, boosting its valuation to $3.5 million, executives announced Monday. Hippocratic AI has raised $404 million in total funding to date, including a $141 million series B round in January and $53 million in series A funding in March 2024.”
  • Per Beckers Clinical Leadership,
    • “Rochester, Minn.-based Mayo Clinic launched a digital tool that allows patients to compare hospitals based on quality metrics.
    • “HealthLocator is a free tool that uses publically available CMS data on clinical quality, hospital patient safety, associated infection metrics and patient experience to rate more than 5,000 U.S. hospitals, according to an Oct. 30 system news release. Learn more about the methodology here. 
    • ‘The tool allows users to search by city, specialty or hospital and compare hospitals based on performance.”
  • TechTarget calls attention to “Stanford Health Care collaborating with a virtual-first provider for pulmonary rehabilitation to expand access to chronic care for COPD patients and improve outcomes.”

Thursday report

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

From Washington, DC,

  • The Hill reports,
    • “Senate Republicans and Democrats are trying to hammer out a proposal to end the 30-day government shutdown as soon as next week, as some centrist Democrats argue behind the scenes that their party has successfully highlighted rising health care costs and it’s time to end the stalemate.
    • “Shutdown fatigue on Capitol Hill is growing as the government stoppage approaches the one-month mark, and the pain is increasing.” * * *
    • “My assessment is that we’ve won anything that we can possibly win and the costs of continuing the shutdown are going to be felt by people who are going to food banks and federal employees,” said one Democratic senator, who requested anonymity to argue that any political benefit of extending the shutdown is about to be outweighed by the harms inflicted on ordinary Americans.”
  • Federal News Network adds,
    • “The White House is tapping into three Defense Department’s accounts to pay troops this week as the government shutdown stretches on.” * * *
    • “Elaine McCusker, a senior fellow at the American Enterprise Institute and former Pentagon comptroller, said the $5.3 billion the White House identified this time, combined with roughly $1.5 billion left from the $8 billion transferred earlier this month, could be just enough to keep this round of paychecks flowing. And if there’s a gap, she said, the government could temporarily delay some payroll-related costs to make the numbers work.
    • “If it is short, they may be able to defer payment of some military pay expenses that come at the end of the month, not in the middle of the month, like retirement accrual and Social Security tax until the shutdown ends. If they say the cost was $6.5 billion in the middle of month, and they have $6.8 with those various sources available for tomorrow, it could be pretty close. And if they have a little bit of a gap, they might be able to temporarily defer some of those other payroll-type costs until they can replenish the fund,” McCusker told Federal News Network.
    • “The Defense Department also received a $130 million donation from billionaire Timothy Mellon to fund military salaries.:
  • Modern Healthcare tells us,
    • “If Express Scripts and other pharmacy benefit managers thought they could circumvent stricter laws governing their business practices by making changes on their own, these lawmakers want them to know the strategy isn’t working.
    • “Leading supporters of PBM legislation such as Sen. Chuck Grassley (R-Iowa) and Rep. Buddy Carter (R-Ga.) reacted positively to Cigna’s announcement that its Express Scripts subsidiary would phase out drug rebates and phase in upfront discounts for commercial health plans. They also said their bills remain necessary, and that they expect passage after years of letdowns.”
  • MedTech Dive informs us,
    • “The United States and China reached a consensus agreement related to tariffs and other trade-related priorities during a Thursday morning meeting in South Korea between the countries’ leaders and other officials.  
    • “As part of the arrangement, the U.S. will lower tariffs related to fentanyl trafficking on imports from China to 10%, down from 20%, effective immediately, U.S. President Donald Trump told reporters Thursday on Air Force One. A spokesperson for China’s Ministry of Commerce confirmed the reduction and also said the U.S. would further extend its pause on reciprocal tariffs on imports from China for another year. 
    • “Despite the tariff reductions, goods from China will still face a duty burden of 47%, Trump and U.S. Trade Representative Jamieson Greer said Thursday while traveling to the U.S. from South Korea.” 
  • Kevin Moss, writing in Federal News Network, offers advice to FEHB plan members who need to choose a new plan during the upcoming open season.
    • “If you take no action during Open Season [when your current plan is leaving the FEHB Program for 2026], you’ll be automatically enrolled in GEHA Elevate for 2026. While this plan may work for some, it’s important to review all available FEHB options in your area to find the coverage that best fits your needs.”

From the Food and Drug Administration front,

  • MedTech Dive relates,
    • “The Food and Drug Administration sent a warning letter to Philips related to quality issues at three facilities that manufacture ultrasound equipment and software for heart imaging and telehealth.
    • “The FDA sent the warning letter to Philips on Sept. 9 and posted it on Tuesday. The communication followed inspections in early 2025 of three facilities in Washington, Pennsylvania and the Netherlands.
    • “The FDA raised concerns with Philips’ process for handling complaints and device corrections. Philips has tasked a specific unit with handling complaints, but the company lacks documentation to show that complaints are being evaluated.” 
  • Beckers Hospital Review adds,
    • “Teva Pharmaceuticals has voluntarily recalled more than 580,000 bottles of prazosin hydrochloride, a high blood pressure drug, because of a carcinogenic ingredient. 
    • “In safety and quality testing of the medication, the drugmaker detected N-nitroso Prazosin impurity C, which can increase cancer risk if exposure exceeds acceptable levels set by the FDA. 
    • “The recall is classified as Class II, which the FDA defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A study published Oct. 30 by the American Heart Association found that people have an elevated risk of heart attack and stroke following flu and COVID-19 infection. Researchers reviewed 155 previous studies investigating the association between viral infections and the risk of heart attack and stroke and found that people are four times more likely to have a heart attack and five times more likely to have a stroke in the month after having the flu. Following a COVID-19 infection, people are three times more likely to have a heart attack or a stroke 14 weeks after, with an elevated risk remaining for a year. 
    • “Additionally, the study found chronic infections such as HIV, hepatitis C and varicella zoster virus — which causes shingles — can increase long-term elevated risks of cardiovascular events. Researchers said preventive measures, including vaccination, could be important for reducing the risk of heart attacks and strokes, particularly for individuals who already have heart disease or heart disease risk factors.” 
  • Genetic Engineering and Biotechnology News relates,
    • “As flu season approaches and there is a push for vaccination, a study by Allen Institute scientists has uncovered why vaccines can trigger a weaker response in older adults—aged about 65 years—and suggests how these immune responses might be improved. In what they state is the largest study of its kind, the researchers used techniques including single-cell RNA sequencing (scRNA-seq), proteomics, and spectral flow cytometry to profile the immune systems of younger and older individuals over time.
    • “The findings showed that T cells—key players in coordinating immune responses—undergo profound and specific changes as we age. These changes, the results suggest, are not random or a byproduct of chronic disease and inflammation but are a fundamental feature of healthy aging and will happen to all of us as we get older. The changes could also point to why vaccines, including the annual flu shot and COVID-19 boosters, tend to be less effective in older adults. The scientists suggest that their insights, newly reported in Nature, could open the door to designing more effective vaccines.”
  • The New York Times lets us know,
    • “One of the most popular mental health innovations of the past decade is therapy via text message, which allows you to dip in and out of treatment in the course of a day. Say you wake up anxious before a presentation: You might text your therapist first thing in the morning to say that you can’t stop visualizing a humiliating failure.
    • “Three hours later, her response pops up on your phone. She suggests that you label the thought — “I’m feeling nervous about my presentation” — and then try to reframe it. She tells you to take a deep breath before deciding what is true in the moment.
    • “You read her answer between meetings. “I’m pretty sure my boss thinks I’m an idiot,” you type. The therapist responds the next morning. “What evidence do you have that she thinks that?” she asks. She tells you to write a list of the available evidence, pros and cons.
    • “Text-based therapy has expanded swiftly over the past decade through digital mental health platforms like BetterHelp and Talkspace, which pair users with licensed therapists and offer both live chat and as-needed texting sessions. A new study published on Thursday in the journal JAMA Network Open provides early evidence that the practice is effective in treating mild to moderate depression, finding outcomes similar to those of video-based therapy.”
  • Per NPR
    • “Teens who start using cannabis before age 15 are more likely to use the drug often later in their lives. They are also more likely to develop mental and physical health problems in young adulthood compared to their peers who did not use the drug in adolescence.
    • “Those are the findings of a new study in JAMA Network Open.
    • “This further builds the case that cannabis use in adolescence adverselyaffects the [health] trajectories of those who use it,” says psychiatrist Dr. Ryan Sultan at Columbia University, who wasn’t involved in the new research.
    • “The new study used data from the Québec Longitudinal Study of Child Development. Researchers in Montreal, Canada, have been following more than 1,500 kids since birth into young adulthood to understand the factors that influence their development and their health. Among the various aspects of the kids’ lives and habits scientists have recorded is cannabis use between ages 12 and 17.”
  • Per Health Day,
    • “For patients with irritable bowel syndrome (IBS), the Mediterranean diet (MD) is superior to traditional dietary advice (TDA) as first-line therapy, according to a study published online Oct. 27 in the Annals of Internal Medicine.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports
    • “Weight-loss drugs are propelling a new gold rush for the pharmaceutical industry.     
    • “On Thursday, Eli Lilly LLY delivered a surge in quarterly revenue thanks to its medicines, while Novo Nordisk NOVO.B, the other big player in the market, took the unusual step of lobbing an unsolicited multibillion-dollar bid for a weight-loss-drug startup that had agreed to sell to Pfizer.
    • “Altogether, the moves showed the strength—and allure—of one of the biggest and fastest-growing categories in pharmaceuticals.”
  • and
    • Cigna Group CI logged higher profit and revenue in the third quarter, but the company warned that profits for its pharmacy-benefits business will be squeezed next year.
    • Cigna shares dropped 17% in early trading Thursday, signaling investor concern about the PBM profit warning.
    • The company said during a call with analysts that it expected earnings growth in 2026, but warned that profits for its pharmacy-benefit management unit would drop that year, due to renegotiated contracts with three major clients and costs associated with adopting an ambitious new payment model.
    • Analysts zeroed in on concerns about the PBM’s future margins, and Cigna executives said the new contract terms would continue in the future, but the heightened investment costs would only span 2026 and 2027. 
    • Overall, Cigna said, it expected to return to typical company-level earnings growth targets in 2027 despite the pressure, and it said that its new PBM payment model should ultimately generate profits similar to the current one. 
  • Beckers Hospital Review adds,
    • “Pfizer is pushing back against a $9 billion unsolicited bid from Denmark-based Novo Nordisk to acquire Metsera, calling it an illegal attempt to eliminate a U.S.-based competitor. 
    • “Pfizer said the structure of Novo Nordisk’s proposal — which includes $56.50 per share in cash, plus contingent value rights worth up to $21.25 per share — is designed to circumvent antitrust laws and poses significant regulatory and executional risk, according to an Oct. 30 news release. 
    • “The offer values Metsera at about $6.5 billion in equity and up to $2.5 billion in potential milestone payments, for a total consideration of up to $9 billion, according to Novo Nordisk’s Oct. 30 news release.”
  • Per Fierce Healthcare,
    • “Why did for-profit hospital systems blow past analysts’ expectations this quarter? Short answer—they got paid.
    • “Across the past week’s earnings statements and calls, executives outlined solid demand for care services and no major curveballs surrounding expense lines like labor spending. Both of those trends are expected to continue through the end of this year and into 2026, they said, with other hurdles like elevated supply spend from tariffs not yet creeping into purchasing contracts.”
  • Beckers Hospital Review adds,
    • “A year after flagging a spike in payer denials, Community Health Systems’ top executive says the situation has stabilized.
    • “It has really not gotten any worse,” Interim CEO Kevin Hammons said on the Franklin, Tenn.-based for-profit system’s Oct. 24 earnings call.
    • “On CHS’ October 2024 call, Mr. Hammons said the system was making incremental investments in its centralized financial services processes and teams, as well as its physician advisor program to “continue to advocate for the appropriate classification of care for our patients and payment for the services our health systems provide.”
    • “He said on the Oct. 24 call that CHS is also investing in AI tools, using a combination of third-party vendors as well as internally developed products for its revenue cycle team. 
    • “I would say we’ve been able to kind of hold things stable, which would indicate that the payers are probably also denying more claims,” he said. “We’ve been better at overturning some of those denials in order to kind of keep things status quo.”
  • and
    • identifies “26 hospitals and health systems that received credit rating downgrades from Fitch Ratings or Moody’s Investors Service in 2025.”
  • Per BioPharma Dive,
    • “With quarterly earnings underway, BioPharma Dive is providing a snapshot of some companies’ results and how they’re being received by investors. Today, we’re offering insight into the latest numbers from Alnylam Pharmaceuticals, Biogen, Neurocrine Biosciences and Bristol Myers Squibb.” 
  • Per Fierce Pharma,
    • “With vaccine sales on the decline across the industry, these are tough times for Merck to launch its new pneumococcal shot Capvaxive. But in the third quarter, the company recorded encouraging sales for the vaccine, which is the world’s first pneumococcal shot designed specifically for adults.
    • “Capvaxive generated sales of $244 million in the period, which was up from $129 million in Q2. Over its first four quarters on the market—since the CDC recommended its use in October of last year for people age 50 and older—Capvaxive pulled in sales of $530 million.
    • “[Capvaxive] is off to a very strong start,” Merck chief financial officer Caroline Litchfield said during the company’s quarterly conference call Thursday.”
  • Fierce Healthcare tells us,
    • “Blues-backed pharmacy benefit manager Prime Therapeutics is expanding its partnership with Sempre Health nationwide after finding significant savings in a pilot program.
    • “Blue Cross Blue Shield of North Carolina, a client of Prime, launched with Sempre in 2022. Sempre identifies the members that are taking preferred, single-source drugs to manage chronic needs and automatically surfaces discounts at the pharmacy counter.
    • “Members also receive text message alerts when it’s time for them to refill a prescription, with savings incentives that increase as they refill their key medications on time.
    • “Over the past three years, the partnership with Blue Cross NC has enrolled more than 19,500 members and managed more than 70,000 refills, saving members $4.7 million. It’s with these results under their belts in the initial collaboration that Prime decided to expand the relationship.”
  • 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 brensocatib (Brinsupri™, Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “ICER’s report on this therapy was the subject of the September 2025 public meeting of the CTAF, one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations“

From the AI front,

  • Beckers Health IT informs us,
    • “After restructuring as a for-profit company, ChatGPT developer OpenAI’s newly named nonprofit arm will dedicate part of $25 billion toward health.
    • “The OpenAI Foundation, which holds a stake in the for-profit valued at $130 billion, is committing the $25 billion to health and curing diseases and technical solutions to AI resilience.
    • “The OpenAI Foundation will fund work to accelerate health breakthroughs so everyone can benefit from faster diagnostics, better treatments, and cures,” OpenAI board chair Bret Taylor wrote in an Oct. 28 blog post. “This will start with activities like the creation of open-sourced and responsibly built frontier health datasets, and funding for scientists.”

In Memoriam

  • OPM Director Scott Kupor shares sad news,
    • “It is with deep sadness I share the news of the passing of Kathleen “Kathy” McGettigan, a former Acting Director of the U.S. Office of Personnel Management and a cherished member of the OPM family.
    • “Although I did not have the privilege of knowing Kathy personally, I have learned how profoundly she influenced this agency and the people who make it what it is today. Those who worked alongside her describe a leader of great integrity, compassion, and commitment — someone who led with both excellence and heart.
    • “Kathy devoted her career to public service, guiding OPM and the federal workforce with wisdom and grace during times of transition. Her impact continues to be felt in the work we do each day and in the community of dedicated public servants she helped shape.
    • “As we reflect on Kathy’s life and contributions, I hope we take a moment to honor her memory — not only through our words, but through our shared commitment to the mission she cared so deeply about: serving the federal workforce and, through it, the American people.
    • “If you would like to read more about her life, you can view Kathy’s obituary: Kathy McGettigan Obituary“
  • RIP

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–

From Washington, DC,

  • CBS News reports,
    • “Senators appeared cautiously optimistic about the direction of bipartisan talks, with key deadlines putting pressure on both sides to reach a resolution to reopen the government. 
    • “Sen. Lisa Murkowski, an Alaska Republican, told reporters she’s more optimistic. She said there’s been a “significant uptick in bipartisan conversation,” reiterating what Thune said earlier in the day.
    • “Sen. Gary Peters, a Michigan Democrat who said he’s part of the conversations, told CBS News that “we’ve been talking regularly throughout the shutdown,” while pointing to the impact of rising health insurance premiums.
    • “So obviously now people are starting to see the impact of these increases now that prices are coming out,” Peters said.
    • “And Democratic Sen. Elissa Slotkin of Michigan said that while a “refusal to meet and have a real conversation” had been holding lawmakers back, now “we’re having those conversations.” 
  • The Wall Street Journal confirms,
    • “The financial pain from the government shutdown is spreading and the legislative options for both Republicans and Democrats on Capitol Hill are narrowing, prompting a pickup in informal talks to resolve the nearly monthlong impasse.
    • “Lawmakers point to deadlines within days that they hope will force a breakthrough before money stops flowing for food-stamp benefits and enhanced healthcare subsidies. The White House, which is ensuring that troops are paid, has urged GOP leaders to not hold votes on stand-alone proposals to pay other government workers or otherwise lessen the impact of the shutdown, sparking angry words on the Senate floor but also potentially hastening a compromise.
    • “Senate Majority Leader John Thune (R., S.D.) told reporters Wednesday that conversations have “ticked up significantly” and said, “hopefully that will be a precursor of things to come.” He said that the focus was on conversations among rank-and-file lawmakers and pointed to moderate Democrats as a way out of the shutdown.
    • “I’m hoping that something here very soon will be fruitful,” he said.
    • “Sens. Catherine Cortez Masto (D., Nev.), Jeanne Shaheen (D., N.H.) and Lisa Murkowski (R., Alaska)—all centrists—agreed with the assessment. “More of the conversation is happening,” Cortez Masto said.”
  • The Paragon Health Institute tells us,
    • On October 28, CMS put out information on [Affordable Care Act] exchange plan premiums and offerings. The data make clear that Obamacare’s underlying subsidies remain extremely generous; taxpayers continue to cover nearly all premium costs for most enrollees. According to CMS:
      • On average, subsidies are projected to cover 91 percent of the lowest cost plan premium in 2026 for eligible enrollees. This is higher than the 85 percent it covered in 2020—the last coverage year before Biden’s temporary COVID-19 credits.
      • The average enrollee’s monthly premium payment for the lowest-cost plan will be $50 in 2026—about $20 less than in 2020.
      • In 2026, nearly 60 percent of eligible re-enrollees will have access to a plan in their chosen category at or below $50 in monthly expense to them—compared to 56 percent in 2020.
      • In 2026, 95 percent of enrollees will have access to three or more Qualified Health Plan (QHP) issuers, compared to 68 percent in 2020. 
  • Per MedTech Dive,
    • “New blood pressure treatments from Medtronic and Recor Medical will now be covered by Medicare.
    • “The Centers for Medicare and Medicaid Services on Tuesday finalized a national coverage determination for renal denervation to treat people with uncontrolled hypertension, a widespread condition that raises the risk of heart disease and stroke.
    • “The decision is expected to increase use of the technology to fill a treatment gap for patients when lifestyle changes and prescription medications have failed to lower their blood pressure.”
  • The American Hospital Association News informs us,
    • “The Consumer Financial Protection Bureau released a notice Oct. 28 clarifying that the Fair Credit Reporting Act preempts state laws on credit reporting, including those regarding medical debt. As a result, medical debt must be included on credit reports, regardless of state laws disallowing the inclusion of medical debt on credit reports.”

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The Food and Drug Administration wants to speed the development of biosimilars, announcing new guidance on Wednesday that would no longer require the makers of copycat biologics to run human trials showing their products are as effective and safe as their branded counterparts.
    • “The FDA agency said the policy shift should make biosimilar development faster and cheaper, estimating that companies could now save $100 million in development costs per product. At a press conference, Commissioner Martin Makary said the move could help create “more competition [and] more choices” for people who need biologic medicines.
    • “Wednesday’s announcement builds on previous FDA initiatives to ease the development and review of biosimilars. In 2024, the agency proposed dropping studies analyzing the effects of “switching” between branded products and biosimilars. That move was designed to make it easier for biosimilars to gain “interchangeability” status, which allows pharmacists to substitute them for a biologic without a doctor’s prescription.” 
    • See FACT SHEET: Bringing Lower-Cost Biosimilar Drugs to American Patients.

From the public health and medical / Rx research front,

  • The American Hospital Association News lets us know,
    • “The Centers for Disease Control and Prevention released an advisory Oct. 29 on three unrelated cases of clade I mpox recently identified in California. The agency said that viral genomic data suggested the cases are likely part of the same cluster and may be linked to a case from August with recent travel to an area with clade I mpox spread. The CDC said there is high suspicion of community spread since the three September cases had no history of recent travel and no obvious common exposure or epidemiological link between them. The agency recommended that laboratories use tests targeting a viral essential gene, as mutations of the virus can impact clade-specific polymerase chain reaction tests. The risk of clade Ib mpox to the public is low, the CDC said.” 
  • Per the University of Minnesota’s CIDRAP
    • Two hotspots for measles activity in the United States—neighboring counties in Arizona and Utah and Upstate South Carolina—are reporting more measles cases, and the Centers for Disease Control and Prevention (CDC) says the United States now has 1,648 confirmed cases this year, 87% of which are outbreak-associated. 
    • The national total is 40 more cases than last week. 
  • and
    • “A meta-analysis of 511 studies on US COVID-19, respiratory syncytial virus (RSV), and influenza vaccines find meaningful protection against severe disease and hospitalization, evidence that can help fill the void in vaccine guidance formerly provided by independent federal review.
    • “The large-scale project, conducted by the Center for Infectious Disease Research and Policy’s (CIDRAP’s) Vaccine Integrity Project (VIP), was published today in the New England Journal of Medicine. CIDRAP, which publishes CIDRAP News, started the VIP to provide science-based information to help people, communities, policymakers, and clinicians make informed vaccine choices.
    • “Contrary to assertions by US Health and Human Services Secretary Robert F. Kennedy Jr., the study shows that “there is absolutely no shortage of data regarding these vaccine products for COVID, flu, and RSV,” co-senior author Caitlin Dugdale, MD, an infectious disease physician at Massachusetts General Hospital, told CIDRAP News. 
    • “In fact, there’s a sea of data that’s far too big for any one person to try to get through,” she added. “The findings of our review really reaffirm the safety and effectiveness of these vaccines.”
    • “VIP scientists and other experts presented initial findings from their analysis in August. Today’s data represent the group’s final peer-reviewed outcomes, adding to the veracity of their results.”
  • NPR relates,
    • “The number of people using injectable obesity treatments is increasing rapidly, and it is leading to declines in obesity, according to a new survey by the Gallup National Health and Well-Being Index.
    • “The obesity rate dropped to 37% of U.S. adults this year, down from a high of 39.9% three years ago, according to the survey.”
    • “The survey found that the number of Americans taking drugs like semaglutide (which include the brands Ozempic and Wegovy) or tirzepatide (under the brands Zepbound and Mounjaro) for weight loss more than doubled over the past year and a half. That’s 12.4% of respondents taking the drugs compared with 5.8% in February 2024, when Gallup first measured it. The new treatments are in a class of drugs known as GLP-1 agonists, and this generation of very effective GLP-1 agonists were approved for obesity treatment in the U.S. market in 2021.”
  • Healio adds,
    • “GLP-1s hold promise as a potential treatment for alcohol and substance use disorders, according to an expert endocrine consult published in the Journal of the Endocrine Society. 
    • “Treatment options for alcohol and substance use disorders are currently limited, according to Lorenzo Leggio, MD, PhD, clinical director, deputy scientific director and chief of the translational addiction medicine branch of the National Institute on Drug Abuse Intramural Research Program of the NIH, and colleagues. The researchers discussed how GLP-1s are tied to several changes in the central nervous system and suggested the activation of GLP-1 receptors could reduce “drug-seeking and consummatory behaviors.
    • “This research is very important because alcohol and drug addiction are major causes of illness and death, yet there are still only a few effective treatment options,” Leggio said in a press release. “Finding new and better treatments is critically important to help people live healthier lives.”
  • MedPage Today notes,
    • “For women over 35 considering fertility preservation, freezing their eggs as soon as possible may be vital for increasing the probability of having at least one live birth, a retrospective cohort study found.
    • “Among women who froze their eggs at 35 or older, the probability of live birth decreased by 13% per year (OR 0.79, 95% CI 074-0.84), reported Michelle Bayefsky, MD, from RMA of New York and Mount Sinai School of Medicine in New York City, at the American Society for Reproductive Medicine annual meeting.
    • “Nearly half (49%) of patients who froze their eggs between 35 and 37 achieved at least one live birth while only 13% of patients who underwent oocyte cryopreservation over age 42 did.”
  • Per Health Day,
    • “Trauma exposure and traumatic stress are common among adolescents, according to a study published online Oct. 27 in Pediatrics.
    • “Brooks R. Keeshin, M.D., from the University of Utah in Salt Lake City, and colleagues described rates of trauma exposure and traumatic stress symptoms among youth aged 11 to 19 years who presented to primary care clinics for well-child visits between July 2022 and June 2024. Youth completed the Triple Screen, including the Pediatric Traumatic Stress Screening Tool, the Patient Health Questionnaire-Adolescent version, and the Generalized Anxiety Disorder 7 as part of routine care; the Columbia Suicide Severity Rating Scale was completed when indicated.
    • “Overall, 15.5 percent of 24,675 youth reported trauma exposure and 7.5 percent reported moderate or high symptoms of traumatic stress. The researchers found that the likelihood of reporting a traumatic experience was higher for female and Hispanic youth. High anxiety and/or depression symptom scores were seen in only half of youth with high traumatic stress symptoms. Older, female, Hispanic individuals and those with prior mental health diagnoses more often had high traumatic stress symptoms. Compared with those with low or moderate traumatic stress, adolescents with trauma and high traumatic stress were 10 times more likely to have a high risk for suicide, representing 48 percent of all youth at high risk for suicide.”
  • Per Fierce Pharma,
    • “Merck & Co. and Eisai previously had high hopes for their Keytruda-Lenvima combination in a liver cancer subtype based on positive progression-free survival data, but now the combo’s promise has once again been dented by a miss on another endpoint.
    • “PD-1 inhibitor Keytruda and tyrosine kinase inhibitor (TKI) Lenvima, when added to standard transarterial chemoembolization (TACE), couldn’t help patients with unresectable, non-metastatic hepatocellular carcinoma (HCC) live longer compared to TACE alone, Merck and Eisai’s phase 3 LEAP-012 study has found.
    • “The overall survival miss was determined at a pre-specified interim analysis, Merck said in an Oct. 29 press release, as the likelihood of meeting the threshold for statistical significance in the endpoint at a future analysis was deemed “low” by the companies.
    • “With that, the partners are shutting the study down, although further analysis of the data is ongoing.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health raised its earnings expectations for 2025 after the healthcare behemoth’s Aetna health insurance and pharmacy units improved their performance in the third quarter.
    • “CVS now expects full year adjusted earnings between $6.55 to $6.65 per share, up from its previous guide of between $6.30 to $6.40 per share, according to financial results released Wednesday. 
    • “However, the company swung to a loss in the third quarter, driven by a $5.7 billion goodwill impairment charge linked to CVS’ healthcare delivery assets — particularly its move to decelerate growth of its Oak Street Health senior care clinics, CEO David Joyner said on an earnings call Wednesday morning.” 
  • and
    • “Centene posted a net loss of $6.6 billion in the third quarter after recording a massive charge to reflect the company’s waning value amid challenging market conditions, including Republican cuts to the healthcare system.
    • “Centene recorded a non-cash goodwill impairment charge of $6.7 billion, driving the payer deep into the red. Without the charge, which has no effect on Centene’s cash or underlying operations, the company would have posted a small profit.
    • “Overall, executives said they were pleased with Centene’s performance in the quarter, including keeping a lid on spiking medical costs in Medicaid and the Affordable Care Act exchanges. Centene increased its full-year earnings outlook following the results.”
  • and
    • “Universal Health Services raised its financial forecast for 2025 on Monday, after the operator posted third quarter revenues that increased 13.4% year over year to $4.5 billion. 
    • “The for-profit operator attributed the revenue increase in part to a $90 million boost from Washington D.C.’s recently approved Medicaid supplemental payment program, as well growth in its acute care volumes.
    • “The health system now expects to take between $17.3 billion and $17.4 billion in revenue for the year, up from its previous forecast of $17.1 billion to $17.3 billion.”
  • Fierce Healthcare adds,
    • “In Teladoc Health’s third-quarter 2025 financial results, released Wednesday, the company reported falling U.S. revenue along with an uptick in its international business.
    • “The telehealth giant reported $626.4 million in third-quarter revenue, down 2% year-over-year, and a $49.5 million loss, or a loss of 28 cents per share, for the quarter that ended Sept. 30. 
    • “The company’s adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) was down 16% year-over-year, to $69.9 million.”
  • and
    • “Pharma giant Eli Lilly tapped Walmart to offer in-store pickups of Zepbound vials, marking the first retail collaboration for its direct-to-consumer platform LillyDirect.
    • “Walmart, which operates nearly 4,600 pharmacies nationwide, will be the first in-store pickup pharmacy for LillyDirect’s self-pay single-dose vials of the weight loss drug, according to the company. It marks the first time patients using LillyDirect, the company’s DTC healthcare platform, can access self-pay pricing for Zepbound vials at a retail pharmacy location.
    • “The offering will be available by mid-November, the companies said. The service provides consumers with additional convenience, access and choice in how they get their medication, the companies said.”
  • Alan Fein, who writes the Drug Channels blog, offers his thoughts on the Cigna/Evernorth decision to move away from drug rebates.
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of semaglutide (injectable Wegovy®, and a yet to be approved oral formulation) (Novo Nordisk) and tirzepatide (Zepbound®) (Eli Lilly and Company) for the treatment of obesity. ICER is also assessing how these treatments affect additional obesity-related outcomes.
    • “Over the past few years, semaglutide and tirzepatide have revolutionized the management of obesity,” said ICER’s Chief Medical Officer, David Rind, MD, MSc. “In addition to typically producing meaningful weight loss, these therapies reduce cardiovascular risk and improve multiple other aspects of the metabolic syndrome as well as additional obesity-related conditions.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on November 13, 2025. The New England 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.” * * *
  • Healthcare Dive relates,
    • “National insurers are generally good at making accurate negotiated rate data available in compliance with federal price transparency rules, although there’s still room for improvement, according to a new analysis from transparent pricing company Turquoise Health.
    • “That’s likely due to large payers having more resources to issue and monitor machine-readable files of rates. Small and regional payers tend to be less successful, Turquoise found.
    • “Still, the company cautioned the results should not be taken as a true measure of compliance, given only states or the HHS can determine that. Instead, Turquoise said its goal with the report is to prevent payer transparency from stagnating or worsening by creating more accountability.”
  • Per MedTech Dive,
    • “Thermo Fisher Scientific will acquire clinical trial data firm Clario Holdings for $8.9 billion in cash, the companies announced Wednesday. Clario is currently held by a shareholder group led by Astorg and Nordic Capital, Novo Holding and Cinven.
    • “In addition, Thermo has agreed to pay $125 million in January 2027, and up to $400 million in payments based on the performance of the business in 2026 and 2027. 
    • “Clario integrates clinical trial endpoint data from devices, sites and patients. The company is expected to complement Thermo’s existing clinical research services, and to drive costs out of the drug development process for customers, J.P. Morgan analyst Casey Woodring wrote in a research note.” 
  • Per Fierce Pharma,
    • “Picking a date for a press conference in Puerto Rico in the middle of hurricane season can be risky business. But, these days, there’s no stopping Eli Lilly’s whirlwind of manufacturing investment announcements.
    • “Wednesday, the Indianapolis company revealed its plan to spend $1.2 billion to upgrade its manufacturing complex in Carolina, Puerto Rico. The outlay comes amid a deluge of commitments by Lilly to bolster its ability to produce drugs in the U.S. Since 2020, the company has earmarked more than $50 billion to increase its domestic manufacturing capabilities, it said.
    • “Lilly said the investment at its Puerto Rico site will allow it to manufacture more of its “growing portfolio” of oral medicines, which include treatments in neuroscience, oncology, immunology and cardiometabolic health.”

In Memoriam

  • The Washington Post reports,
    • Ruth Lawrence, who pioneered the science of breastfeeding, dies at 101. A trailblazer for women in medicine, she dedicated her career to teaching mothers and medical professionals about the benefits of breastfeeding.
  • The Miami Herald reports,
    • “Dr. Michael Zinner, who helped establish the Miami Cancer Institute of Baptist Health South Florida, died Saturday at his Coral Gables home from Stage IV pancreatic cancer after a self-diagnosis and tests confirmed the disease in August 2024. Zinner, 80, was with his family, his son Darren said. The same disease killed his third wife, Rhonda “Ronny,” in 2014 and inspired his move back to Miami to lead the cancer institute.
    • “Sad and tragic to have passed from a disease from which he has such deep experience, and even sadder that he is no longer able to pass on that knowledge to many more people,” his son Dan Zinner said.”

RIP.

Monday report

David Ermer–CDC, Congress, COVID-19, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Roll Call informs us,
    • “Appropriators could finish drafting a compromise version of a three-bill spending package for fiscal 2026 in “two or three days” once the partial government shutdown is over, House Appropriations Chairman Tom Cole, R-Okla., said last week.
    • “The shutdown has stalled work on full-year appropriations for more than three weeks, but Cole said lawmakers in both chambers are close to finishing compromise drafts of the Agriculture, Legislative Branch and Military Construction-VA bills. Those can’t move forward, however, until the government reopens, he said.”
  • The Wall Street Journal adds,
    • “The nation’s largest federal workers’ union called for Congress to end the shutdown now in its fourth week, putting new pressure on Senate Democrats who have repeatedly blocked a Republican measure to reopen the government.
    • “It’s time to pass a clean continuing resolution and end this shutdown today,” said Everett Kelley, president of the American Federation of Government Employees, or AFGE, which represents more than 800,000 employees, referring to a short-term spending bill.
    • “Kelley called the situation an “avoidable crisis” that is harming families and communities. “Both political parties have made their point, and still there is no clear end in sight,” he said.
    • “The union’s demand—a clean continuing resolution—is the same approach the Republicans have urged Democrats to adopt for the past month, though AFGE didn’t mention either party by name. The union didn’t immediately reply to a request for comment.”
  • The Hill notes,
    • “Speaker Mike Johnson (R-La.) on Monday said House Majority Leader Steve Scalise (R-La.) is working with the chairs of three House committees to compile a Republican health care plan as the government shutdown nears the one-month mark and Democrats demand action on expiring ObamaCare subsidies.” * * *
    • “The heads of those House committees of jurisdiction involved in the health care plans would be Ways and Means Chair Jason Smith (R-Mo.), Energy and Commerce Chair Brett Guthrie (R-Ky.), and Education and Workforce Chair Tim Walberg (R-Mich.).”
  • The Defense Department issued a Federal Register notice describing TRICARE benefit changes for 2026.
  • Per an ERISA Industry Committee news release,
    • “The ERISA Industry Committee (ERIC) and employee benefit industry groups today urged The U.S. Departments of Labor, Health and Human Services, and Treasury (the Tri-Departments) to take immediate action to address severe negative consequences of the Independent Dispute Resolution (IDR) process under the No Surprises Act. Despite the Act’s clear goals of protecting patients from surprise medical bills and fostering fair payment negotiations, employers warn that certain providers have increasingly exploited the IDR process.” * * *
    • “The employers called on the Tri-Departments to take three immediate steps to restore the legitimacy of the IDR system, including:
      • Strengthen enforcement to ensure only eligible claims are submitted to IDR.
      • Increase transparency in arbitration decisions and require clear rationale when awards deviate from the qualified payment amount (QPA).
      • Penalize abuse by providers who repeatedly submit ineligible claims.
    • Read the entire employer letter here
  • Federal News Network tells us,
    • “Current and former federal employees affected by the massive 2015 Office of Personnel Management data breach may be losing their identity protection services in the coming year.
    • “IDX, the company providing these services since 2015, sent out emails earlier this month telling recipients of their identity protection services that they would have to renew on their own dime after receiving services for 10 years paid for by the government.
    • “IDX, which has held the identity protection and credit monitoring contract since 2015, sent at least three emails out over the last few weeks offering customers a discount to renew their subscriptions.”
  • Fierce Pharma notes,
    • “More and more, as momentum builds for the soon-to-be-blockbuster Winrevair, Merck’s $11.5 billion buyout of Acceleron in 2021 is looking like a savvy move.
      The FDA has signed off on a label update for the first-in-class activin signaling inhibitor, which was the key piece of the acquisition. The new approval adds language to the medicine’s label about its ability to reduce patients’ risk of hospitalization for pulmonary arterial hypertension (PAH), lung transplantation and death.
    • “Paving the way for the label update were results from the phase 3 Zenith trial, which enrolled 172 PAH patients at the highest risk of mortality—those in the World Health Organization Functional Class (FC) III or IV—and achieved its primary endpoint of time to clinical worsening to first morbidity or mortality event.
    • “Winrevair, added to maximum background therapy, reduced the risk of these events by 76% versus placebo. Patients in the trial’s treatment cohort received a subcutaneous dose of Winrevair every three weeks, and the median follow-up with patients was 10.6 months.”

From the public health and medical / Rx research front,

  • MedPage Today points out,
    • Hormel Foods is recalling nearly 4.9 million pounds of frozen boneless chicken it sold to restaurants, cafeterias, and other outlets after customers reported finding metal in the products, the U.S. Department of Agriculture (USDA) announced. (AP)
    • And a South Dakota company is recalling more than 2.2 million pounds of Korean barbecue pork jerky sold at Costco and Sam’s Club stores, again because the product may be contaminated with pieces of metal, USDA said. (AP)
  • The Hill relates,
    • “More than two years after the mpox outbreak in the U.S. was declared over, a new crop of cases in California has infectious disease experts on edge. 
    • “The mpox outbreak that spread through men who have sex with men was declared over at the start of 2023, though low-level transmission has persisted since then.” * * * 
    • “A collection of three unrelated mpox cases recently detected in California is raising concerns, as they were caused by a more infectious, more dangerous strain of the virus called clade I mpox.”
    • “Joseph Cherabie, a member of the HIV Medicine Association board of directors and assistant professor of infectious diseases at Washington University St. Louis, said it was “only a matter of time” before clade I mpox was detected in the U.S.” * * *
    • “If we learned anything from the 2022 outbreak, casual contact, and, you know, transmission through things like clothing, shared clothing, or sitting on the same seat in a subway or anything like that — that did not occur,” Cherabie said. “You need very close, intimate contact with these lesions. So that is why the predominant means of transmission previously was through sexual contact.”  
  • Your Local Epidemiologist writes in her Substack blog to which the FEHBlog subscribes,
    • “After an unusually quiet October for respiratory viruses, an RSV wave is starting to take hold. Flu remains remarkably low, and Covid-19 transmission is at one of the lowest points we’ve seen in months.
    • “Although CDC data remain paused because of the federal government shutdown, emergency department records compiled by PopHIVE show RSV activity is starting to climb, especially among children under four. This follows a familiar pattern: the virus first hits the youngest children (particularly those under one year) before spreading to adults, often about a month later.”
  • The American Medical Association tells us what doctors wish their patients knew about ovarian cancer prevention. “What is known about risk factors has not translated into practical ways to prevent most cases of ovarian cancer. Three ob-gyns share what to keep in mind.”
  • The New York Times reports,
    • “Surgeons removed a genetically modified pig kidney from a 67-year-old man last week, nearly nine months after he received the pioneering procedure at Massachusetts General Hospital in Boston, officials said on Monday. The kidney was removed “after a period of decreasing kidney function,” according to a statement from the hospital.
    • “The patient, Tim Andrews, lived with the pig kidney for a record-setting 271 days. He was the fourth person in the United States to receive a genetically modified pig kidney. The first two patients died shortly after their transplants; the third had her kidney removed after 130 days, when her body rejected the organ.
    • “Tim set a new bar in xenotransplantation,” the Mass General Brigham statement said, referring to the process of transplanting organs from one species into another.
    • “Mr. Andrews “will now resume dialysis and remain on the list for a human donor kidney,” the hospital added.
    • “The nation faces an acute shortage of human organs. More than 100,000 people are on waiting lists to receive an organ transplant; roughly 90,000 of them are awaiting kidneys.
    • “The shortage has prompted an effort to genetically modify pigs so that their organs can be safely transplanted into humans.”
  • Per MedPage Today,
    • “Surgery alone offered improved survival and a potential cure for select pancreatic cancer patients.
    • “Clear surgical margins and negative lymph node status were essential to better survival.
    • “The findings came from a registry database, not a randomized clinical trial.”
  • and
    • “Estetrol (E4) — one of four natural estrogens — significantly reduced the weighted weekly score of moderate-to-severe vasomotor symptoms in postmenopausal women, according to an analysis of two phase III trials.
    • “Among more than 1,200 women included in E4COMFORT I and E4COMFORT II, the weekly weighted score (WWS) of vasomotor symptoms (VMS), which combined the number and severity of hot flashes, decreased in all treatment arms, including placebo, reported Ekta Kapoor, MBBS, of the Mayo Clinic in Rochester, Minnesota, at the Menopause Society annual meeting
    • “Both examined doses of once-daily oral E4, 15 mg and 20 mg, resulted in greater and statistically significant reductions compared with placebo, and the 20-mg dose demonstrated the largest and earliest reductions, Kapoor reported.”
  • The Washington Post reports,
    • “A sweeping study found thousands of stillbirths occur without clear warning signs
    • “A study led by researchers at Harvard and Mass General Brigham shows stark socioeconomic divides and thousands of unexplained losses, even in seemingly healthy pregnancies.
    • “The study published Monday shows that nearly 30 percent of stillbirths occur in pregnancies that did not appear linked to any previously identified health or clinical risks. The study also found that stillbirth continues to fall unevenly along racial and socioeconomic lines, with Black families and poorer communities being hit hardest.”
    • “Mark Clapp, an obstetrician and maternal-fetal medicine specialist at Massachusetts General Hospital and one of the study authors, said better screening and monitoring are urgently needed.”
  • Per Health Day,
    • Lousy sleep might be an early warning sign for suicide risk among teenagers, a new study says.
    • Teenagers who didn’t get enough sleep on school nights or suffered from interrupted sleep had a significantly higher risk of suicide, researchers reported Oct. 23 in the journal Sleep Advances.
    • “Adolescents who experience difficulties maintaining and obtaining sufficient sleep are more likely to report a suicide attempt several years later,” said lead researcher Michaela Pawley, a doctoral candidate in psychology at the University of Warwick in the U.K.
    • “Poor sleep is not just a symptom of wider difficulties, but a significant risk factor in its own right,” Pawley said in a news release. “Addressing sleep problems could form a vital part of suicide prevention strategies.”
  • Per STAT News,
    • “Experimental CAR-T therapies from Cabaletta Bio and Bristol Myers Squibb have induced complete remissions in patients living with a severe inflammatory muscle disease, results from dual clinical trials being presented this week show. 
    • “The new data, while still preliminary, add to evidence reported over the past several years that personalized cell therapies — already used to treat blood cancers — may be curative for patients with serious autoimmune disorders.
    • “These are patients who take three-to-five medicines every day, every week, every month, at great cost both healthwise and financially,” said Steven Nichtberger, CEO of Cabaletta. With a one-time CAR-T treatment, “We’re showing we can eliminate all of those drugs, giving them the opportunity to no longer be patients. We are freeing them from their disease.” 
  • BioPharma Dive relates,
    • “Shares of Intellia Therapeutics lost nearly half their value Monday a serious safety event led the company to temporarily pause a pair of Phase 3 trials testing its gene-editing drug against the rare disease transthyretin amyloidosis.
    • “Intellia said it has stopped enrollment and dosing in both late-stage studies of the therapy, codenamed nexiguran ziclumeran or nex-z, while it works on new measures to ensure patient safety. The company plans to consult with regulators and independent experts to “develop a strategy to resume enrollment as soon as appropriate,” CEO John Leonard said in the statement.
    • “The enrollee, a man in his 80s and treated on Sept. 30, on Friday experienced a “grade 4” spike in liver enzymes that were concerning enough to require hospitalization. Prior to the stoppage, Intellia had already enrolled more than 650 people with the cardiomyopathy form of transthyretin amyloidosis in one trial and 47 with the polyneuropathy form in its other study.”
  • and
    • “An experimental medicine from BridgeBio Pharma succeeded in a late-stage study in a form of limb-girdle muscular dystrophy, positioning the company to engage U.S. regulators about a potential approval filing. 
    • “Study volunteers with that “type 2I/R9” form of limb-girdle and treated with the drug, BBP-418, had a roughly 17% improvement after three months in “αDG glycosylation,” an important marker of muscle stability and the trial’s main objective. That increase was sustained after 12 months, compared to no change on this measure among placebo-treated participants. No new or “unexpected” safety findings were observed, the company said Monday. 
    • “BridgeBio also said drug recipients had “statistically significant” and “clinically meaningful” improvements after a year in all key trial endpoints studied, including measures of walking ability and lung function. The company will discuss the results with the FDA later this year and intends to submit an approval application in the first half of 2026.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Cigna’s Evernorth division is rolling out a rebate-free model for its pharmacy benefit manager, Express Scripts—meaning one of the industry’s “Big Three” is moving away from the oft-criticized approach.
    • “Cigna announced Monday morning that what it’s calling a “new era” for its PBM unit is built on three core elements: transparency, a better patient experience and greater support for community pharmacies. The company said that Evernorth will shift to a pass-through model, where discounts are available upfront to members.
    • “Cigna’s insurance arm, Cigna Healthcare, will adopt this model for its fully insured plans in 2027, and the more transparent model will be the standard offering for all of Express Scripts’ customers beginning in 2028.
    • “Pharmacy benefit managers have successfully driven down costs for Americans with generics and now with biosimilars,” said Adam Kautzner, president of Evernorth Care Management and Express Scripts, in the release. “In this new era of pharmacy benefits, we’re creating more choice for Americans by lowering the costs of expensive brand-name drugs while driving accelerated adoption of generics and biosimilars.”
    • “Our innovative model is a win-win for Americans and their employers—lower costs for Americans, real-time transparency for employers and renewed trust in pharmacy benefits for all,” Kautzner said.
    • Per the announcements, Evernorth estimates that the new model will save members an average of 30% each month on brand-name medications. It will lean on technology to compare pricing options for the patient and ensure they see the lowest cost when they pick up a prescription.
  • Brilliant.
  • Beckers Payer Issues lets us know,
    • “Blue Cross Blue Shield of Massachusetts is expanding its claims review process to address what it is describing as potential overcoding among physicians who routinely bill for high-complexity visits.
    • “The new policy takes effect for dates of service on or after Nov. 3 and applies to a small subset of clinicians whose billing patterns stand out from peers, BCBSMA told Becker’s.
    • “Under the program, BCBSMA will review evaluation and management claims from providers who consistently bill visits at the highest complexity levels (4 and 5) to ensure that the services billed match the severity of the conditions reported. Reimbursement may be reduced if the insurer decides that overcoding has occurred.
    • “BCBSMA estimates that 1% to 2% of primary care physicians and 3% to 4% of specialists in its network will be subject to the expanded process. Clinicians can submit additional documentation and appeal to have claims reinstated as originally billed.”
  • Per Medical Economics,
    • “Sites of care, price transparency, competition and consolidation all play a role in U.S. health care in 2025, and likely will in coming years.
    • “There also could be changes in store — and there should be, if the nation wants to improve the value of a vital service now accounting for almost 20% of America’s gross domestic produce, according to health care economic analyst Trilliant Health.
    • “The new report, “2025 Trends Shaping the Health Economy,” posits that the health care system is at a crossroads with a choice to make: find ways to improve outcomes and value from within, or face new external regulation that might not be what the sector wants.”
  • and
    • “A new KFF/Washington Post survey offers a detailed look at how American parents view their children’s health — and who they trust most for medical guidance. Conducted in summer 2025, the survey shows a nation largely united in concern over issues like mental health and diet, but deeply divided on vaccines, public health institutions and the balance between personal freedom and medical authority.
    • “For physicians, the results underscore a growing need to rebuild and reinforce trust at the point of care, as families increasingly navigate conflicting messages from social media, politics and federal agencies.
    • “Find an in-depth analysis of the survey’s findings here.”
  • Per Fierce Healthcare,
    • “Community Health Systems (CHS) announced Friday evening a new definitive agreement to sell three Pennsylvania hospitals to affiliates of Tenor Health Foundation, a recently formed nonprofit. 
    • “Early discussions on the deal and a signed letter of intent had been reported during the summer and confirmed at the time by company representatives. The deal is a second attempt for CHS to sell off its Commonwealth Health system after a prior purchase agreement with WoodBridge Healthcare was called off last year. 
    • “Involved in the transaction are the 186-bed Regional Hospital of Scranton, the 122-bed Moses Taylor Hospital and the 369-bed Wilkes-Barre General Hospital, as well as their affiliate sites.
    • “Financial terms of the deal are not being disclosed. CHS said in its announcement that a close is contingent on Tenor finalizing its funding, as well as on customary regulatory approvals.”   
  • Per Beckers Hospital Review,
    • “Nearly 75% of active drug shortages in the U.S. began in 2022 or earlier, with some persisting for more than five years.
    • “According to a report from the American Society of Health-System Pharmacists released in September, the number of active shortages declined to 214 in the third quarter of 2025 — the lowest since early 2018 and a steep drop from the record 323 reported in the first quarter of 2024. While the trend is improving, the ASHP warned that persistent shortages of commonly used medications, including lorazepam and triamcinolone injections, continue to disrupt care.
    • “Long-term shortages now account for most active disruptions, with the ASHP noting that nearly 75% began in 2022 or earlier. These prolonged gaps in supply often require health systems to modify treatment plans, locate alternatives and update clinical workflows.”

Thursday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The government shutdown is expected to continue into next week as the Senate is expected to adjourn Oct. 23 with no plans to vote this weekend. The chamber Oct. 22 failed for a 12th time to advance the House-passed continuing resolution to extend government funding. The House remains out of session with no plans to return at this time. Lawmakers remain at an impasse.”
  • and
    • “The Senate Committee on Health, Education, Labor and Pensions Oct. 23 held a hearing discussing the 340B Drug Pricing Program and its growth and impacts on patients. The AHA provided a statement to the committee in support of the program and highlighted benefits for patients and hospitals, such as lowering drug costs and subsidizing chronic underpayments from Medicare and Medicaid.
    • The AHA also discussed the impact of 340B in rural communities. “Most rural hospitals lose money when providing critical medical services needed in their communities and therefore rely on 340B savings to remain operational and provide specialty care,” the AHA wrote. “If these services were unavailable in their communities, rural patients would be forced to drive far distances to access the same level of care, which for many would be impossible.”
  • The Senate did adjourn until Monday late this afternoon.
  • Federal News Network adds,
    • “A Republican measure to immediately pay federal employees who are working without pay under the shutdown failed to advance in the Senate on Thursday. But some lawmakers still appeared optimistic about reaching a bipartisan agreement on paying federal employees within the next few days.
    • “Democrats largely voted down the GOP’s “Shutdown Fairness Act,” resulting in a vote of 54-45 on the Senate floor. The Republicans’ motion on the bill failed to reach the 60 votes required to “invoke cloture” — a type of vote that limits debate to more quickly move legislation to a final vote.
    • “Three Democrats — Sens. John Fetterman (D-Pa.), Jon Ossoff (D-Ga.) and Raphael Warnock (D-Ga.) — voted alongside Republicans on the motion. Sen. Tim Sheehy (R-Mont.) did not vote.” * * *
    • “Despite Thursday’s failed votes, Sen. Ron Johnson (R-Wis.), the lead co-sponsor on the Shutdown Fairness Act, expressed optimism for reaching a bipartisan agreement to pay federal employees while the shutdown continues.
    • “We’re basically in agreement here,” Johnson told reporters. “I’m willing to add furloughed workers, and now it’s just kind of down to the reductions in force … I don’t want to completely constrain the President, but I don’t mind making sure that Congress has a say in this as well.”
    • “I’m actually quite hopeful — I think we can fix it over the weekend,” Johnson added. “This could open up a path to opening the government as well.”
  • and
    • “The Centers for Medicare & Medicaid Services is temporarily bringing furloughed employees back to work to help individuals sign up for health insurance plans during the open enrollment period.
    • “CMS told employees in an email obtained by Federal News Network that it is bringing back its furloughed employees, starting Monday, Oct. 27.
    • “The agency said it will repurpose some of its funding to ensure furloughed and excepted employees are paid on time for days worked during the open enrollment period.
    • “CMS said all these employees “will be paid for the days you work” or take approved leave, beginning on Oct. 27. Employees working these days will receive a partial paycheck on Nov. 7.”
  • The Wall Street Journal notes,
    • “Lawmakers failed to provide a last-minute reprieve for air-traffic controllers and other federal workers who are set to miss their next paychecks due to the government shutdown, with legislation failing in the Senate and Republicans warning they didn’t expect any financial rescue from the administration.
    • “The expected lapse in pay exacerbates concerns over possible shortages of air-traffic controllers, a job that requires long, intense hours and sophisticated training. But worries about air travel could also help drive Republicans and Democrats to find a way out of the funding impasse, now into its fourth week. Absenteeism and air-travel problems played a central role in bringing about the end of the record monthlong lapse in President Trump’s first term.” * * *
    • “In 2019, the strain on air-traffic controllers was widely seen as helping bring the government shutdown to an end, after staffing shortages and sick calls began disrupting flights. So far, U.S. flight cancellations and delays have stayed generally in line with their level during the same period last year, according to data from FlightAware.
    • “Union officials say hardships are growing for airport workers.”
  • Tammy Flanagan, writing in Govexec, lets us know that “the government shutdown has raised lots of questions about the retirement process, and retirement benefits, for federal employees while agencies remain closed. Here are some of the most pressing answers.”
  • AHIP and the Blue Cross Blue Shield Association has posted a No Surprises Act survey concluding that
    • “The Independent Dispute Resolution (IDR) process itself is costly, diverting funds plans could otherwise have spent on patient care or used to lower premiums and patient cost-sharing.
    • “The vast majority of out-of-network claims covered by the NSA are resolved through prompt payment without dispute or further negotiation.
    • “IDR is being overused by some providers who submit high volumes of disputes, many of which are ineligible, which adds costs to the health care system.”

From the Food and Drug Administration front,

  • Biopharma Dive reports,
    • “The Food and Drug Administration has approved GSK’s multiple myeloma drug Blenrep, officially ending the hiatus of a medication pulled from the U.S. market three years ago.
    • “Yet the agency on Thursday issued a mixed decision in clearing the drug’s return. It approved Blenrep’s use alongside one regimen involving another myeloma medicine, Velcade, but not in combination with another therapy called Pomalyst. It also cleared Blenrep in people whose multiple myeloma has returned, or hasn’t responded, after at least two prior lines of therapy, instead of one, as GSK had requested.
    • “Still, in a statement, GSK Chief Scientific Officer Tony Wood referred to the decision as a “significant milestone.” Wood added that “there is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse and re-treating with the same mechanism of action often leads to suboptimal outcomes.”
    • “The clearance completes a turnaround for Blenrep, which was initially approved in 2020 but traveled an unusual path since.”
  • Yahoo relates,
    • Coca-Cola has issued a recall of three of its most popular soda brands after discovering potential metal fragments in certain batches. If you’ve got a cold soft drink chilling in your kitchen, there are key batch codes you’ll want to check—especially since thousands of cans have already been pulled from store shelves. Read on to find out whether your soda is affected, what to do if it is, and how to stay safe. * * *
    • “According to a Coca-Cola spokesperson, the recall was limited to select regions of Texas, specifically the McAllen/Rio Grande Valley and San Antonio areas. The company confirmed that no products outside these locations were impacted.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A new analysis of a major clinical trial affirmed that Wegovy, the popular obesity drug, lowers the risk of major heart issues like heart attacks and strokes in some adults, but showed that weight loss could not fully explain the cardiovascular benefits.
    • “How else, exactly, the drug protects the heart remains a mystery.
    • “Obesity is intricately linked with poor heart health, and losing excess weight can blunt the risk of cardiovascular concerns. But the analysis, published on Wednesday in The Lancet, found that a shrinking waist size — a measure of shedding belly fat — was responsible for only around a third of the observed cardiovascular benefits in people who took Wegovy. In their first 20 weeks of taking the drug, patients experienced cardiovascular benefits no matter how much weight they lost.
    • “As it stands now, we do not know how to account for that other roughly two thirds of the benefit,” said Dr. Michael Lincoff, a professor emeritus of medicine in the department of cardiovascular medicine at the Cleveland Clinic and an author of the paper.”
  • BioPharma Dive adds,
    • “Shares of Ventyx Biosciences, a San Diego-based drug company, nearly doubled Thursday morning after the company said an experimental medicine it’s been studying in people with obesity showed significant effects on cardiovascular risk factors in a mid-stage trial.
    • “The medicine, code-named VTX3232, failed to help trial participants lose more weight when given alone or as an add-on therapy to semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy. It did, however, significantly reduce biological markers of inflammation, fat levels and liver illness, Ventyx said late Wednesday.
    • “Analysts argue the results lend more support to Ventyx’s approach of fighting disease by focusing on an inflammasome known as NLRP3. Shares of a rival company also targeting NLRP3, BioAge Labs, jumped more than 30% in early trading Thursday.”
  • Per MedPage Today,
    • “Researchers estimated the long-term cardiovascular effects of sugar rationing in the United Kingdom dating back to World War II.
    • “Early life during this period of restricted sugar intake was tied to lower cardiovascular risks in adulthood after age 40.
    • “Risk reductions reached 20% for cardiovascular disease and 25% for myocardial infarction for people who spent the first 1,000 days after conception under sugar rationing.”
  • The American Medical Association lets us know what doctors wish patients knew about healthy eating.
  • Medscape lets us know what doctors wish patients knew about GLP-1 drugs and oral health.
  • Per Health Day,
    • “Poor blood sugar control in adolescents with type 1 diabetes (T1D) increases the risk for future complications, according to a study published in the October issue of Diabetes Research and Clinical Practice.
    • “Chris Moran, from Monash University in Australia, and colleagues examined the 30-year glycemic trajectory in children with early-onset T1D. The analysis included 30 children with T1D (1990 to 1992) participating in the Cognition and Longitudinal Assessment of Risk Factors study.”
  • Genetic Engineering and Biotechnology News relates,
    • “The link between an extra copy of chromosome 21 and Down syndrome (DS) has been well established for decades. What has not been clear was the genetic basis for the congenital heart defects that are associated with nearly half of babies born with Down syndrome. Now a new study in mice published in Nature describes how HMGN1 disrupts DNA’s packaging and regulation and how this impacts molecular levels in healthy heart development. Details of the work are published in a paper titled “Myocardial reprogramming by HMGN1 underlies heart defects in trisomy 21.”
    • “The work is the result of a collaboration involving scientists from Gladstone Institutes, Sanford Burnham Prebys, and elsewhere. As explained in the paper, the link to HMGN1 was made using human pluripotent stem cell and mouse models of Down syndrome. Specifically, “single-cell transcriptomics showed that trisomy 21 shifts human [atrioventricular canal] cardiomyocytes towards a ventricular cardiomyocyte state,” the scientists wrote. Then, “a CRISPR-activation single-cell RNA droplet sequencing screen of chromosome 21 genes expressed during heart development revealed that HMGN1 upregulation mimics this shift, whereas deletion on one HMGN1 allele in trisomic cells restored normal gene expression.” 
    • “According to Sanjeev Ranade, PhD, assistant professor in the Center for Cardiovascular and Muscular Diseases and Center for Data Science and Artificial Intelligence at Sanford Burnham Prebys, “what our paper did was address a major unresolved question: Yes, three copies of chromosome 21 causes DS, but why? What are the genes on chromosome 21 that are bad if you have them in three copies? How in the world do you try to find those genes?” Ranade is the first author on the paper and also a co-corresponding author. 
    • “While this study was done in mice, there are obvious benefits for research in people. Learnings from this study “could pave the way for treatments to help prevent heart malformations in people with Down syndrome and related heart defects, which would be a major win for patients and their families,” said Deepak Srivastava, MD, president and senior investigator at Gladstone, a pediatric cardiologist at University of California, San Francisco (UCSF). Srivastava is the senior author on the paper and one of its corresponding authors.”
  • and 
    • “Ewing sarcoma is one of the most common bone cancers seen in children, and if it spreads, it can be deadly. A study headed by researchers at the Institute of Mother and Child, Warsaw, have now found that combining first line therapy for Ewing sarcoma with a drug called pazopanib, which was originally developed for renal cell carcinoma, demonstrated striking success in treating a small group of young patients. 85% of the treated patients survived two years after diagnosis, and there was no disease progression for two-thirds of patients. The team calls for larger studies which can develop this treatment further.”
  • Beckers Hospital Review shares a survey of U.S. state based on the readiness to address the healthcare needs of their elderly populations.
    • “Hawaii is the most prepared state to address the healthcare needs of the U.S.’s aging population, while Oregon is the least, according to an analysis by Seniorly and CareScout. 
    • “Seniorly examined each state across three dimensions — population trends, financial readiness and healthcare capacity — to devise the ranking.”
  • The Washington Post answers reader questions about using artificial intelligence as a healthcare guide.
    • “Younger doctors, in particular, are turning to the technology for help with diagnosis and treatment decisions. Two medical educators told me that nearly all of their students and residents use OpenEvidence, a free AI tool trained on medical literature. Wolters Kluwer UpToDate, the gold-standard clinical reference used by as many as 90 percent of physicians, has also added AI features that generate tailored recommendations for specific patient scenarios.
    • “My advice is to frame your curiosity as collaboration, not challenge. You might say, “I was trying to learn more about menopause and found this information. What do you think of it?” You might even ask your doctor if she uses AI herself. That question can open the door to understanding whether the discomfort stems from the technology itself or from a deeper resistance to patients taking a more active role in their care.”

From the healthcare business front,

  • Beckers Hospital Review reports,
    • “GLP-1 prescribing in the US may have reached a plateau, new data suggests. 
    • “Prescribing rates remained stable from June to September, according to an analysis of EHR data from researchers at Truveta — a platform that includes de-identified patient data from more than 900 hospitals to support medical research advancements.
    • “In June, the overall prescribing rate for GLP-1s was 6.22%. By September, that figure was 6.5%, marking a 4.6% increase. The findings were published Oct. 14 in the preprint server medRxiv.“
  • and
    • “Patient experience scores across U.S. hospitals are rebounding slowly after pandemic-era declines. 
    • “According to a Press Ganey analysis of 10.5 million patient encounters released earlier in 2025, “recommend the hospital” scores rose from 69 in 2024 to 70.4 in early 2025, signaling a modest uptick in trust and satisfaction. Scores at medical practices and ambulatory surgery centers have each increased by several points since 2019, while inpatient scores have fallen by 2.2 points in the same period.
    • “The analysis results suggest that while patient experience is improving overall, the biggest strides are occurring outside hospital walls. Outpatient environments are benefiting from targeted digital investments, streamlined access and better communication, while inpatient settings still struggle with coordination, predictability and information flow.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released its new “Launch Price and Access Report,” finding that drug launch prices continue to rise at a rate that exceeds inflation, gross domestic product (GDP) growth, and overall healthcare costs.
    • “ICER’s analysis focused on “net price,” or the actual price paid after rebates and discounts, offering crucial information to policymakers, given that most previous analyses of drug pricing trends focus on the publicly available “list price,” which does not always reflect the actual price paid.
    • “The report, using net prices, found that the inflation-adjusted median annual launch price of drugs increased by 51% from 2022 to 2024, while the annual list price increased 24% during the same period. Even after accounting for the differences in the mix of drugs approved each year (by holding certain characteristics constant, like the number of gene therapies approved), the annual net launch price increased by 33% per year.
    • “ICER also conducted an in-depth review of the 23 drugs in scope that had been previously reviewed by ICER. The analysis indicated that aligning the prices of these therapies with ICER’s Health Benefit Price Benchmark (HBPB) could have saved approximately $1.3 to $1.5 billion in the first-year post-approval alone – savings that could have been redirected to higher-value drugs and services.’
  • Healthcare Dive tells us,
    • “Molina cut its 2025 earnings guidance for the third time this year on Wednesday, citing doggedly high medical costs particularly in its Affordable Care Act plans.
    • “The insurer now projects adjusted earnings per share of $14 this year, down from its prior estimate of “no less than” $19 from July. The earnings reduction is despite Molina now believing it will bring in higher premiums this year.
    • “Molina also posted third quarter results on Wednesday that beat analyst expectations on revenue but missed on earnings. The insurer’s stock plummeted 19% in aftermarket trading following the results.”
  • Fierce Healthcare informs us,
    • “Community Health Systems’ (CHS’) third-quarter performance blew past Wall Street’s expectations with year-over-year same-store gains and shareholder earnings that landed on the right side of zero.
    • “The Franklin, Tennessee-based company is the first of its for-profit peers to report this earnings season. Its stock is trading well above its closing value after hours—a change in pace from last quarter’s stumble.
    • “We were pleased with operating and financial results for the quarter, which generally met our expectations,” Kevin Hammons, president and interim CEO, said in Thursday afternoon’s release on the quarter’s performance.”
  • Per Fierce Pharma,
    • “Even as Roche executives on Thursday espoused confidence in the company’s resilience and growth potential over the next several years, a mix of exchange rate fluctuations and lackluster pharmaceutical sales led to a worse-than-expected third quarter for the Swiss drug giant.
    • “For the first nine months of 2025, Roche’s overall sales grew 7% year over year at constant currencies to 45.9 billion Swiss francs (nearly $58 billion), the company announced Thursday. The bulk of that growth can be attributed to the company’s pharmaceutical division, which has clocked sales growth of 9% at constant exchange rates over the nine-month stretch.
    • “As in previous earnings periods, Roche’s pharma momentum was attributed to the recent performance of Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus.”
    • “Roche’s earnings release reported the company’s sales performance from January through September, and in that span, all five of those franchises charted revenue increases. But looking at the period from July through September specifically, that shine lost some of its luster.”

Monday report

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

From Washington, DC,

  • Govexec reports,
    • “As the Senate continues to take failed votes to reopen the government, the chamber will soon shift to a new approach that would ensure on-time for feds working during the shutdown. 
    • “In its 20th day, Senate Democrats were expected to reject for the 11th time a short-term spending measure to fund agencies through Nov. 21. Senate Republicans are looking to ramp up pressure on Democrats by allowing normal paychecks for employees required to continue reporting to their jobs without immediate compensation during the shutdown. 
    • “Senate Majority Leader John Thune, R-S.D., told reporters he would on Monday evening take the first procedural step to bring the measure up for consideration, with a vote taking place either Wednesday or Thursday. 
    • “They’re all going to get paid eventually, but I think people who are working right now and not getting paid ought to be,” Thune said.” 
  • Before Congress overrides it, here’s a link to OPM’s 89-page long Guidance on Shutdown Furloughs, which the FEHBlog ran across today.
  • Kevin Moss, writing in Govexec, discusses “what FEHB changes mean for your 2026 health coverage. Premiums are shifting, and the government contribution varies. Here’s what to know to avoid surprises and save where you can.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has approved Rybelsus, Novo Nordisk’s oral semaglutide formulation, for reducing the risk of major adverse cardiovascular events in high-risk patients with type 2 diabetes. Rybelsus is officially the first oral GLP-1 drug approved for this indication.
    • “The FDA’s decision was largely based on data from the SOUL trial, which included data from more than 9,000 patients who were randomized to oral semaglutide or a placebo.[1] All patients had type 2 diabetes in addition to known atherosclerotic cardiovascular disease, chronic kidney disease or both. Overall, the study’s primary outcome—a composite of cardiovascular death, nonfatal heart attack or nonfatal stroke—was seen in 12% of oral semaglutide patients and 13.8% of placebo patients. This represents a 14% overall reduction, similar to the results associated with injectable semaglutide.
    • “The FDA originally approved Rybelsus in 2019 to improve glycemic control in adults with type 2 diabetes. At the time, it was the celebrated as the first GLP-1 drug available in pill form—and it still is six years later.”
  • Fierce Pharma adds,
    • “With the lupus treatment landscape poised for a shake-up, Roche is hitting the scene in the U.S. with a new green light for its long-approved blood cancer medicine Gazyva.
    • “Early Monday, Roche’s Genentech announced that the FDA cleared Gazyva (obinutuzumab) to treat adults with active lupus nephritis who are taking standard therapy.
    • “The drug will be given as four initial infusions during the first year of treatment, after which it can be administered twice yearly.” 
  • Per MedTech Dive,
    • “Ōura is pursuing Food and Drug Administration clearance of a blood pressure feature for its smart rings.
    • “Having engaged with the FDA, Ōura has received approval to study the feature in a population of users who are signed up to try experimental features of its devices, the company said Monday. 
    • “Participants will answer health questions. By combining the answers with data from the user’s ring, Ōura will assess the likelihood of the patient having high blood pressure.”

From the public health and medical / Rx research front,

  • The Washington Post reports on “four surprising things that may reduce your risk of Parkinson’s. Research on Parkinson’s is revealing several risk factors related to our lifestyles and environment, and you can act on some of them.”
    • “Parkinson’s disease, once considered relatively rare, is now one of the most common neurological disorders in the world, and the second most common after Alzheimer’s disease. The number of people living with Parkinson’s has more than doubled in the past 25 years to 8.5 million and is predicted to hit 25.2 million by 2050.”
    • “The hallmark symptoms of Parkinson’s — such as tremors, stiffness, and difficulty with balance and coordination — result from the deterioration of neurons in the basal ganglia, an area of the brain that controls movement. While 10 to 15 percent of cases are linked to inherited genetic mutations, the rest are considered “sporadic,” with no known cause.
    • “Although treatments are available that can manage symptoms, there is no cure or therapy that can slow disease progression. But ongoing research on Parkinson’s is revealing several risk factors related to our lifestyles and environment, some of which are actionable.
    • “For example, moderate to vigorous exercise may reduce one’s risk, according to a 2018 meta-analysis, and some studies have shown that healthy diets focused on whole, unprocessed foods might help. Last year, a study found that higher levels of exposure to air pollution were associated with an increased risk of Parkinson’s.”
    • The article offers more tips.
  • The New York Times points out,
    • For the first time, researchers restored some vision to people with a common type of eye disease by using a prosthetic retinal implant. If approved for broader use in the future, the treatment could improve the lives of an estimated one million, mostly older, people in the United States who lose their vision to the condition.
    • The patients’ blindness occurs when cells in the center of the retina start to die, what is known as geographic atrophy resulting from age-related macular degeneration. Without these cells, patients see a big black spot in the center of their vision, with a thin border of sight around it. Although their peripheral vision is preserved, people with this form of advanced macular degeneration cannot read, have difficulty recognizing faces or forms and may have trouble navigating their surroundings.
    • In a study published Monday in The New England Journal of Medicine, vision in 27 out of 32 participants improved so much that they could read with their artificial retinas.
  • The American Medical Association lets us know what doctors wish their patients knew about menopause.
  • Healio tells us,
    • “Exposure to elevated blood pressure through young adulthood was linked to cognitive decline by midlife.
    • “The trend was consistent across race and sex subgroups.”
  • NBC News reports,
    • “With age comes a natural decline in cognitive function, even among otherwise healthy adults without dementia. A new study finds that a cognitive training program may boost production of a brain chemical that plays a role in memory and attention.
    • “Participants who completed game-like activities through BrainHQ, an online subscription program, showed increased production of acetylcholine, sometimes called the “pay attention” chemical. The process that produces acetylcholine in the brain is called the cholinergic system.”
  • Per MedPage Today,
    • “Having shingles boosted the risk of major adverse cardiovascular events (MACE) such as vascular dementia, heart attack, stroke, and death by roughly a quarter — but people who received the recombinant shingles vaccine before developing shingles saw their risks of those outcomes drop by up to half, according to a large retrospective study.
    • “Among more than 174,000 people, ages 50 or older, those who developed a herpes zoster infection were approximately 20% more likely to have a heart attack, 27% more likely to have a stroke, and up to 30% more likely to die than people who didn’t develop shingles, reported Ali Dehghani, DO, of Case Western Reserve University in Cleveland.
  • and
    • “Visceral and liver fat were tied to carotid atherosclerosis in two cohort studies using MRI and ultrasound imaging.
    • “Associations persisted even after accounting for traditional cardiovascular risk factors like cholesterol and blood pressure.
    • “Study authors encourage a healthy diet as a way reduce visceral fat and therefore manage the risk of cardiovascular disease.”
  • Per Genetic Engineering and Biotechnology News,
    • “In a new study published in Cancer Cell titled, “Tumor-infiltrating bacteria disrupt cancer epithelial cell interactions and induce cell-cycle arrest,” researchers from the University of Texas MD Anderson Cancer Center have discovered a previously unknown mechanism that explains how bacteria can drive treatment resistance in patients with oral and colorectal cancer. 
    • “While tumor-infiltrating bacteria have been known to impact cancer progression and treatment, the mechanism has been unclear. Results demonstrate how the bacteria, Fusobacterium nucleatum (Fn), can induce a reversible state, known as quiescence, in cancer epithelial cells to allow tumors to evade the immune system and resist chemotherapy. 
    • “These bacteria-tumor interactions have been hiding in plain sight, and with new technologies we can now see how microbes directly affect cancer cells, shape tumor behavior and blunt the effects of treatment,” said Susan Bullman, PhD, associate professor of Immunology and associate member of MD Anderson’s James P. Allison Institute and corresponding author of the study. “It’s a whole layer of tumor biology we’ve been missing and one we can now start to target. We hope these findings help open the door to designing smarter, microbe-aware therapies that could make even the toughest cancers more treatable.” 

From the HLTH Conference,

  • Modern Healthcare tells us,
  • Healthcare Dive informs us,
    • “Online pharmacy Cost Plus Drugs will be participating in President Donald Trump’s drug price transparency tool, TrumpRx, according to Cost Plus’ founder Mark Cuban.
    • “Cuban shared the news during his keynote at the HLTH conference on Sunday, during which the billionaire entrepreneur and pharmacy disruptor also excoriated the pharmacy benefit manager industry for driving up the cost of U.S. medications.”
  • Per Fierce Healthcare,
    • “At the 2025 HLTH conference in Las Vegas, GE HealthCare unveiled health system partnerships and the latest research projects that are part of its AI Innovation Lab. 
    • “The company is working with the Queen’s Health Systems in Honolulu and Duke Health in Durham to advance the development of its new AI-driven hospital operations software, which will become part of CareIntellect.
    • “CareIntellect, a generative AI platform, is a hub for various GE HealthCare applications and was first announced at HLTH last year. The idea is to enable health systems to easily deploy new applications without a product-by-product integration approach. 
    • “Now you can really have a common data layer, that’s all the data is structured in a way that you can analyze and plug into. You can bring more applications, whether that’s on the operations side, on the care delivery side,” Taha Kass-Hout, GE HealthCare’s global chief science and tech officer, told Fierce Healthcare.”
  • and
    • WeightWatchers is joining forces with Amazon Pharmacy to make it easier for members to access weight management medications.
    • The company announced Monday that through the partnership its members will be able to access information on real-time medication availability, automated coupon savings and home delivery for key medications they use to manage their weight.
    • Amazon Pharmacy will automatically apply coupons for members at the point of checkout, according to an announcement, without the need to submit codes manually. Amazon Prime members have access to two-day home delivery, and in certain locations same-day delivery is available as an option.
    • Scott Honken, chief commercial officer for WeightWatchers, told Fierce Healthcare that the team has had a longstanding relationship with Amazon, but tapping into its pharmacy unit made sense as it looked to improve access and ease for members.
  • and
    • “Artificial intelligence startup OpenEvidence banked $200 million in series C funding, just three months after it raised $210 million in a series B.
    • “The three-year-old company’s valuation hit $6 billion post-series C raise, Daniel Nadler, Ph.D., one of OpenEvidence’s founders confirmed to Fierce Healthcare on Monday. OpenEvidence developed an AI-powered medical search engine and generative AI chatbot exclusively for doctors that summarizes and simplifies evidence-based medical information. 
    • “The New York Times first reported the series C funding Monday morning.
    • “OpenEvidence has raised nearly $500 million since its founding in 2022. Google Ventures led the round. Existing investors Sequoia, Kleiner Perkins, Thrive and Coatue backed the series C. New investors BOND (Mary Meeker), Blackstone and Craft also joined the round.
    • “The company offers its chatbot to physicians for free, and the product has grown organically through word of mouth between doctors, Nadler said.
    • “OpenEvidence plans to use the fresh funding to continue building out its AI technology.”
  • and
    • “Highmark is teaming up with Noom to roll out its weight management solution to members.
    • “Eligible members can enroll in the program and will receive Noom’s services at no cost. Their care journeys can be personalized to meet their individual needs and generally follow three tracks: weight loss and management, diabetes prevention and management.
    • “Maria Baker, vice president for health strategy and delivery at Highmark, told Fierce Healthcare that the partnership with Noom reflects the insurer’s broader commitment to whole-person health, as a holistic weight management program is a logical place to start filling in key gaps in members’ experiences.
    • “The healthcare industry can forever try to make people come to us and think about our language, or we can meet people where they are,” she said. “And one of the best ways to do that is to meet people in a language they understand, and through a door that people are always talking about.
    • “So the weight journey was the most logical place to start,” Baker said.”
  • and
    • “Knownwell picked up $25 million in fresh funding, riding the wave of investment in obesity care.
    • “CVS Health Ventures led the round with participation from MassMutual Catalyst Fund and Intermountain Ventures.
    • “Existing investors a16z Bio + Health and Flare Capital Partners also backed the oversubscribed financing round. The company has raised a total of $50 million to date, with a $20 million round in late 2023.
    • “The startup offers in-person and virtual services as a weight-inclusive primary care and metabolic health company. Knownwell offers broader services beyond just weight management or GLP-1 prescriptions to include nutrition counseling and behavioral health services both online and in person.”

From the U.S. healthcare business front,

  • Beckers Oncology notes,
    • “Philadelphia-based Penn Medicine and Penn Medicine Princeton (N.J.) Health will break ground on a $401 million cancer center Oct. 20 at the Princeton Medical Center in Plainsboro, N.J.
    • “The Penn Medicine Princeton Cancer Center is expected to open in May 2028, according to a Penn Medicine news release.
    • “The center will house more than 40 exam rooms, 30 infusion chairs, two linear accelerators for radiation therapy and a breast imaging center.
    • “Care teams at the cancer center will work with experts from the Penn Medicine Abramson Cancer Center. Patients will also have access to clinical trials and services such as proton therapy and personalized cell therapies through other Penn Medicine care sites, the release said.”
  • Per Fierce Pharma,
    • “Merck has kicked off construction of a new $3 billion facility at its sprawling manufacturing campus in Elkton, Virginia. The investment is part of the New Jersey company’s plan to spend more than $70 billion on manufacturing, R&D and capital projects in the U.S., it announced Monday.
    • “The planned 400,000-square-foot facility will add to Merck’s presence at the massive site at the base of the Blue Ridge Mountains in Virginia’s Shenandoah Valley. The complex already covers 1.2 million square feet and employs more than 1,000.
    • “With the investment spanning active pharmaceutical ingredient and drug product functions, the new plant will support small-molecule production and testing, Merck said. The facility, dubbed as its Center of Excellence for small-molecule manufacturing, could create more than 500 full-time jobs, according to the company.”
  • Modern Healthcare relates,
    • “Hartford HealthCare said Monday it won a bid to purchase two Connecticut hospitals from bankrupt Prospect Medical Holdings. The deal, which is subject to court approval, involves Manchester Memorial Hospital and Rockville General Hospital.” 
  • and
    • “Humata Health will provide its prior authorization automation tool through Microsoft’s generative artificial intelligence assistant, Dragon Copilot.
    • “Microsoft launched Dragon Copilot in March to assist clinicians with documentation, revenue cycle management, patient engagement and decision support. 
    • “The integration will enable clinicians to automate and complete prior authorizations within their workflows, a Humata spokesperson said Monday. Microsoft will determine when the tool will be available through Dragon Copilot, and Humata is discussing the capability with customers, the spokesperson said.”
  • BioPharma Dive lets us know,
    • “The share price of Alto Neuroscience more than doubled at one point Monday, after the psychiatry drug specialist announced plans to hasten the development of a potential depression medicine.
    • “This medicine, code-named ALTO-207, combines a drug already used to treat Parkinson’s disease with the active ingredient in the nausea medication Zofran. Alto got ahold of ALTO-207 this spring, when, for less than $2 million, it bought a slate of experimental, dopamine-boosting drugs from Chase Therapeutics. In unveiling that deal, Alto said it intends to start, by the middle of next year, a mid-stage clinical trial that could serve as the foundation for ALTO-207 getting approved in treatment-resistant depression.
    • “Now, encouraged by a recent meeting with the Food and Drug Administration, the company also wants to initiate a late-stage study by early 2027.”
  • Per Fierce Healthcare,
    • “Humana and Providence on Monday unveiled a new data exchange partnership the major payer and provider said could become a blueprint for the broader industry.
    • “The data sharing ecosystem is slated to go live later this month in an initial rollout focused on automating member attribution for Humana Medicare Advantage members, which the companies said will help the 51-hospital system’s providers understand which patients are considered by Humana to be under their care.
    • “Additional capabilities on the data exchange collaboration’s road map will focus on reducing administrative burden and bolstering clinical decision-making, they said.
    • “The healthcare industry is overwhelmed by fragmented, inconsistent data formats that make care coordination costly and slow,” Michael Westover, vice president of population health informatics at Providence, said in the announcement. “Because we want to be successful in value-based care contracts, Humana and Providence are building a shared foundation of administrative, financial and clinical data using national standards and modern technology.”
    • “More specifically, the pair said they’re using HL7 Fast Healthcare Interoperability Resources (FHIR), Da Vinci Project Implementation Guides and other “modern” application programming interfaces (APIs) to build out their infrastructure.
    • “That framework “will be easily replicable, serving as a scalable model that can transform care across the healthcare industry,” they said.”
  • Per an Institute of Clinical and Economic Review news release,
    • “Today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences, Inc.) for smoking cessation.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions. * * *
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on November 17, 2025.” 

Friday report

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

From Washington DC,

  • Here is a link to today’s Secrets of OPM blog post by OPM Director Scott Kupor.
  • Here are links to Fedweek and Fedsmith articles about OPM’s 2026 government contribution announcement made yesterday.
  • Yesterday, the FEHBlog posted the Internal Revenues Service’s 2026 inflation adjusted amounts.
    • The Wall Street Journal discusses how the adjustments impact federal income taxation.
    • Newfront discusses how the adjustments impact employee benefits.
  • Healthcare Dive notes,
    • “Average Medicare Advantage star ratings for 2026 are essentially flat after a few consecutive years of declines — a good sign for the industry, which had braced itself for lower quality scores.
    • “Still, there was variation in major insurers’ results. The percentage of members in plans rated 4 stars or above, an important cutoff for payers, stayed stable for UnitedHealthcare, dropped for Humana and Aetna, and improved for Elevance and Centene — the five largest publicly traded payers in the privatized Medicare program.
    • “Perhaps the biggest loser is Clover Health. The insurer’s largest contract covering almost all of its MA members dropped below 4 stars — a slip that could cost Clover tens of millions of dollars in earnings, analysts estimate.”
  • The American Hospital Association News tells us,
    • “The federal government shutdown is expected to continue into next week as the Senate adjourned Oct. 9 after failing to pass spending legislation; senators plan to return Oct. 14. Meanwhile, the House currently has no plans to return to session next week. The Senate Oct. 9 failed to adopt the House-passed continuing resolution to fund the government following a seventh vote on the bill. Senate Republicans and Democrats have yet to begin formal negotiations toward a deal.”
  • Federal News Network points out,
    • “Hundreds of thousands of federal employees are set to receive reduced paychecks, now on day 10 of the partial government shutdown.
    • “While most civilian federal employees are expected to get their paychecks sometime in the next couple days, they’ll only take home the pay they earned up until the shutdown began. Regardless of whether they are excepted or furloughed, federal employees will not be paid for any days worked between Oct. 1 and Oct. 4 — the final few days of the most recent two-week pay period.
    • “With the partial paychecks, many federal employees will lose out on hundreds of dollars. The exact timing of when employees receive their paychecks depends on their agency, but many began going out Friday.
    • “It’s also the last paycheck excepted and furloughed employees will receive until the government shutdown ends. The first fully missed paycheck, if the shutdown continues, will be for the pay period of Oct. 5 through Oct. 18. Only federal employees who are considered “exempt” from the shutdown will continue to be paid as usual.”
  • Roll Call reports,
    • ​”The Trump administration made good on its threat to begin mass firings of federal civilian employees Friday while exploring creative avenues to make sure military personnel don’t miss their paychecks slotted to go out next week.
    • “With no end in sight to the partial government shutdown that began 10 days ago, White House budget director Russ Vought announced on X that he has begun executing mass layoffs across federal agencies.
    • “An Office of Management and Budget official said the layoffs are “substantial,” without elaborating. Details began trickling out ahead of a court-ordered deadline by close of business Friday, however, hitting numerous agencies including Treasury, EPA, Homeland Security, Education, and Housing and Urban Development, among others.
    • “Speaker Mike Johnson, R-La., meanwhile, officially canceled votes in the House next week, meaning there is virtually no chance that Congress could pass a stand-alone bill to provide pay to some 2 million troops whose next paycheck is due Oct. 15.
    • “But in keeping with President Donald Trump’s pledges to “take care of” the military while punishing “Democrat agencies,” his administration is looking at how to make sure the troops are kept whole financially. A senior White House official said the administration is “exploring every legal maneuver and option at our disposal to get our troops paid during the Democrat Shutdown.” 
  • STAT News informs us,
    • “The Senate on Thursday passed legislation that would restrict U.S. pharmaceutical and biotechnology companies from doing business with certain Chinese companies, potentially giving the president another way to pressure the industry into doing what he wants. 
    • “The BIOSECURE Act, which was passed as an amendment to the National Defense Authorization Act, has been a long time coming. A more aggressive version of the bill was introduced in the Senate in December 2023. The House proposed similar legislation the next month.
    • “BIOSECURE is not over the finish line yet, but it’s significant that the Senate included it in the National Defense Authorization Act, because the defense budget bill has passed every year for decades. The House passed its version of the defense bill earlier in the year without the BIOSECURE Act, so the two chambers would need to agree to include BIOSECURE in the final version of the defense budget bill when reconciling differences between their versions of it.”
  • The AHA News adds,
    • “The AHA discussed ways hospitals and health systems are leveraging artificial intelligence for care delivery in a statement submitted to the Senate Committee on Health, Education, Labor and Pensions for a hearing held Oct. 9 titled, “AI’s Potential to Support Patients, Workers, Children, and Families.” The AHA highlighted examples of AI applications in hospitals, such as diagnostic imaging, ambient listening tools and scheduling for patients and staff.
    • “Hospitals recognize that AI tools hold tremendous promise to alleviate administrative burden and enhance clinical care,” the AHA wrote. “Among other benefits, these innovations can improve workflow, enhance the overall patient experience by reducing wait times and support timely medical interventions.”
    • “The AHA also discussed potential risks of AI in health care, such as commercial insurers using it to determine disposition of claims and prior authorizations, which has exacerbated inappropriate denials. The AHA advocated for the use of clinicians to independently review care recommendations.”
  • The University of Minnesota’s CIDRAP relates,
    • “A federal vaccine advisory group has established a panel to review the safety and efficacy of the childhood immunization schedule, according to a document posted yesterday on the Centers for Disease Control and Prevention (CDC) website.
    • “The Childhood and Adolescent Immunization Schedule Workgroup (WG), established within the CDC’s Advisory Committee on Immunization Practices (ACIP), will review data and “clinical and scientific knowledge” and present its findings to help ACIP members make policy recommendations. 
    • “As part of ACIP’s core mission to develop recommendations on the use of vaccines in the civilian population of the United States, the committee is standing up a WG focused on assessing the safety and effectiveness of the childhood and adolescent schedule,” the document states.
    • “Among the topics the group will review are the timing and order of different childhood vaccines, administering different vaccines at the same time, the safety of certain vaccine ingredients, and the different childhood vaccine schedules used in other countries.”

From the Food and Drug Administration front,

  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved another new treatment option for heart-failure related edema. 
    • “Just weeks after its approval of bumetanide nasal spray for the treating edema associated with congestive heart failure, kidney disease and liver disease, the agency has given the greenlight to Lasix ONYU, a new drug-device combination from SQ Innovation, for adult patients with chronic heart failure. 
    • “Lasix ONYU provides patients with injections of a high-concentration formulation of furosemide. The injections are delivered with a small two-in-one device. While the base of the device is reusable, only to be replaced after 48 treatments, the other part of the device is used once and then discarded. According to SQ Innovation, this new-look design helps ensure the delivery device can be manufactured at a low enough price point so the treatment remains affordable.
    • “In one recent analysis published in European Heart Journal – Cardiovascular Pharmacotherapy, researchers found that the Lasix ONYU technology was linked to a bioavailability similar to receiving furosemide through an IV. Treatment was also confirmed to be “feasible and well tolerated.”

From the. public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention is not updating its respiratory illnesses data channel during the shutdown.
  • Dr. Tom Friden, a former CDC Director, writes in the Wall Street Journal about the simple steps that can prevent dementia.
    • “When it comes to healthy aging, personal responsibility matters. But American healthcare also suffers from systemic failures. Despite spending more than $4 trillion annually, we get the most important things, such as blood pressure control, right at most half the time. Our system doesn’t incentivize doctors to deliver the preventive care that matters most. For instance, they are paid little or nothing for making an effort to control a patient’s blood pressure.
    • “The tools for a healthy, dementia-free future exist: blood pressure control, appropriate statin and other therapy, smoking prevention and cessation support, and comprehensive primary care focused on prevention. We need a healthcare system that delivers them reliably, for all our sakes.”
  • Per Health Day,
    • “Heart-related health problems might affect as many as 1 in 7 pregnancies, even among women without any prior heart disease, a new study says.
    • “Researchers found a steady increase in heart-related health problems among more than 56,000 pregnancies between 2001 and 2019 in New England.
    • “Heart attack, stroke, heart failure, blood clots, high blood pressure and heart-related maternal death affected about 15% of pregnancies during that time, researchers reported Oct. 6 in the journal Circulation.
    • “Our findings showcase an alarming trend of rising real-world burden of pregnancy-related cardiovascular complications and highlights pregnancy from preconception to the postpartum period as a crucial window of opportunity to implement primary prevention strategies and optimize cardiovascular health,” concluded a team led by Dr. Emily Lau, a cardiologist at Massachusetts General Hospital in Boston.”
  • Per MedPage Today,
    • “New-onset atrial fibrillation (Afib or AF) was surprisingly common after coronary artery bypass grafting (CABG), but its burden quickly diminished to near zero after 30 days, according to long-term continuous ECG monitoring data.
    • “With a monitor implanted during surgery, patients at two German centers showed a 48% incidence of new-onset Afib in the first year after CABG, with a median Afib burden of 0.07% (or 370 minutes).
    • “It turned out that on days 1-7, the median Afib burden was 3.65% (368 minutes), dropping quickly thereafter to 0.04% (13 minutes) on days 8-30 and 0% (0 minutes) on days 31-365, according to researchers led by Florian Herrmann, MD, of LMU University Hospital in Munich, Germany.
    • “Although the incidence of new-onset AF after CABG in this study was higher than previously reported, the AF burden in these patients was very low, especially after 30 days,” the authors reported in JAMA.
    • “This low burden calls into question whether long-term oral anticoagulation is necessary in patients with new-onset AF after CABG. The very low burden provides a likely explanation for why observational studies have failed to demonstrate reduced stroke rates with oral anticoagulation in this patient group,” Herrmann’s group suggested.”
  • Per the American Journal of Managed Care,
    • “A smartphone app significantly reduced depressive symptoms and improved self-esteem and quality of life in individuals with intellectual disabilities.
    • “The study addressed a research gap, highlighting the app’s potential as an accessible mental health intervention for an underserved population.
    • “Limitations include self-reported data, potential bias, and lack of long-term follow-up, affecting the generalizability of results.
    • “Future research should explore optimal app use, caregiver involvement, and accessibility barriers to enhance mental health support for individuals with IDs.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “AstraZeneca is the latest major drugmaker to agree to a deal with the Trump administration on lowering the prices of its drugs, some of which will be available for purchase through a government website next year, President Trump said Friday. 
    • “The agreement, which entails offering “most-favored nation” drug pricing, follows Pfizer’s deal to reduce prices for its drugs sold in the Medicaid program and through a new direct-purchasing service to be branded TrumpRx.
    • “AstraZeneca will similarly offer all prescription drugs on the government website, TrumpRx, which the administration said it will launch in 2026, said Mehmet Oz, administrator for the Centers for Medicare & Medicaid Services.
    • “In addition to the lower drug prices for people on Medicaid, all new AstraZeneca drugs introduced to the market will be launched at most-favored nation pricing, which is tied to comparable prices in other wealthy nations.” 
  • Reuters adds,
    • “Retail pharmacies and prescription drug savings site GoodRx (GDRX.O)
      are talking with the Trump administration about joining its TrumpRx website, they told Reuters, suggesting an expansion beyond the early description of it as a link to pharmaceutical companies’ direct discounts.” * * *
    • “The National Community Pharmacists Association and the National Association of Chain Drug Stores, which represent companies like Walgreens and Costco (COST.O), said they were also talking with administration officials.”
  • The Wall Street Journal also lets us know,
    • “Johnson & Johnson JNJ is in talks to buy Protagonist Therapeutics in a deal that would solidify the companies’ existing partnership, according to people familiar with the matter.
    • “A deal is not guaranteed and the exact details being discussed couldn’t be learned, the people said. 
    • “Protagonist had a market value of over $4 billion as of Thursday’s close. Including a typical premium, a deal would likely value the company well above that. 
    • “”J&J is already working with Protagonist to develop an oral treatment for immune diseases including plaque psoriasis and ulcerative colitis and has the exclusive rights to commercialize the product. It already owns close to 4% of Protagonist’s shares, according to FactSet.
    • “By acquiring Protagonist, the healthcare conglomerate would also gain access to the drug rusfertide, from Protagonist and partner Takeda Pharmaceutical4502 -2.63%decrease; red down pointing triangle. Rusfertide has shown promise in late-stage testing in treating a rare blood cancer called polycythemia vera. 
    • “Both assets would complement J&J’s portfolio of immune and cancer drugs.” 
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is joining big pharma’s rush into “in vivo” cell therapies, paying $1.5 billion to acquire Orbital Therapeutics for a technology designed to rewire the immune systems of people with inflammatory conditions.
    • “The deal announced Friday gives Bristol Myers ownership of a company that’s been working on ways to genetically modify immune cells inside the body. Orbital’s lead program, OTX-201, does so by sending into cells “circular” RNA instructions training them to seek out cells with a particular protein flag. OTX-201, which is envisioned as an autoimmune disease treatment, could begin human testing next year.
    • “The acquisition expands Bristol Myers’ presence in cell therapies. The company is already one of the field’s leaders, with multiple marketed medicines for blood cancers. But, like its peers, Bristol views autoimmune disorders as a way to potentially broaden use of the complex treatments.”
  • Per MedTech Dive,
    • “Zimmer Biomet has launched two orthopedic devices with Paragon 28, the foot and ankle specialist it bought for $1.1 billion early this year. 
    • “The new products, which Zimmer reported Wednesday, add treatments for a type of shinbone break and hindfoot injuries to the company’s portfolio.
    • “Introducing the devices continues Zimmer’s efforts to maintain Paragon’s double-digit growth and expand its sports medicine, extremities and trauma (SET) business.”
  • The Employee Benefits Research Institute released its 2025 Employer Mental Health Survey.
  • Fierce Healthcare adds,
    • “Most employers offer coverage for mental health services, but where they fall short is in tracking whether those benefits are working, according to a new survey.
    • “The report, conducted by the Employee Benefit Research Institute (EBRI), found that 97% of employers offer mental health coverage and 67% offer coverage for substance abuse treatment. However, only 22% said they actively monitor whether employees are using the benefits.
    • “In addition, there is a significant opportunity for employers to do more in tracking network adequacy, the study found. Forty-seven percent of those surveyed said they receive details from vendors or collect data on provider-to-enrollee ratios, while 44% said they track employees’ distance to providers and 48% said they monitor wait times.
    • “Fewer than one-third (31%) said they collect data on out-of-network care use, which is a major barrier to behavioral health access, per the report.”
  • KFF-Peterson Health System Tracker studies “how much do people with employer plans spend out-of-pocket on cost-sharing?”
    • “By cost-sharing type, average spending on deductibles and coinsurance has increased, while copayments have remained flat relative to inflation since 2013. However, since 2021, inflation (16%) and spending on deductibles (13%) have grown at similar rates. Deductibles rose rapidly before 2019, however starting in about 2019 employers have held deductibles constant.
    • “In 2023, 66% of people with employer coverage spent at least $100 on out-of-pocket health care expenses. Among them, 39.7% spent between $100 and $999 on average, while 26% spent $1,000 or more. Over time, the share of enrollees facing over $1,000 in annual out-of-pocket costs has steadily increased.  Conversely, 18% of people with employer coverage incurred no out-of-pocket costs, and 15.4% spent less than $100 in 2023.
    • “Regarding total health spending, 56% of people with employer coverage spent $1,000 or more, including 41% who spent between $1,000 and $9,999 and 15% who spent $10,000 or more. Meanwhile, 12% of enrollees used no health care billed to their health plan in the year, which further highlights the uneven distribution of health care costs across the insured population under employer plans.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Health Economics Methods Advisory (HEMA) yesterday released its first ever Draft Report focused on the assessment of the benefits of treatment that are appropriate to consider in economic evaluation for health technology assessment (HTA) decision-making.
    • “HEMA has been convened by the leaders of three global HTA organizations to independently assess new methods and processes. The three institutions include ICER, England’s National Institute for Health and Care Excellence (NICE), and Canada’s Drug Agency (CDA-AMC).
    • “This draft report will be open for public comment until October 30, 2025, providing a unique opportunity for all stakeholders to engage in the report development process.
    • “If you are interested in submitting a public comment on the Draft Report, visit https://hemamethods.org/our-research/.”

Midweek report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports.
    • “As the government shutdown entered its second week, Democratic lawmakers insisted the tide is shifting toward a deal as some hard-line Republicans express support for extending health insurance subsidies, despite blanket opposition from Republican leadership to any agreement in advance of reopening the government. 
    • “Ending the standoff appears unlikely in the short term — votes aimed at doing so Wednesday yielded similar results as before, with the GOP’s continuing resolution going down for a sixth time, 54-45. The same three Democratic caucus members — Catherine Cortez Masto of Nevada, Angus King of Maine and John Fetterman of Pennsylvania — voted in favor. The Democrats’ continuing resolution was also blocked.
    • “As for the parameters of a potential deal, House Minority Leader Hakeem Jeffries, D-N.Y., once again ruled out a one-year extension of the subsidies. Democrats have called for a permanent extension of the premium tax credits but asked by reporters if a two-year extension was possible, Jeffries didn’t rule it out.”
  • The Wall Street Journal explains who currently gets subsidies in return for receiving coverage under the Affordable Care Act.
  • Because the 2019 shutdown ended due to an air traffic controller walkout, Govexec observes,
    • “The Federal Aviation Administration reported no travel delays due to staffing levels at U.S. air traffic control facilities Wednesday, following a day of some delays related to above-average absences at a handful of facilities.
    • “An FAA operational plan posted about noon Eastern Time on Wednesday, the eighth day of the federal government shutdown, showed no facilities impacted by “staffing triggers.” A day earlier, the same memo showed staffing levels affected operations at major hub airports in Phoenix and Denver, as well as a smaller airport in Burbank, California.
    • “Air traffic controllers are essential to the functioning of the nation’s air transportation system and must continue to work during a shutdown, though they are not paid while it is ongoing.
    • “The group has not yet missed a paycheck during the current lapse in federal funding. The first impact most federal employees will see on their pay will be Friday, when electronic funding transfers are made for the pay period from Sept. 24 to Oct. 7. 
    • “Because Congress has not appropriated money beyond Sept. 30, they would only receive a partial paycheck. Future paychecks would not be allocated until the government reopens.”
  • Per Fierce Healthcare,
    • “The top senator on healthcare policy is taking a hard look at the American Medical Association’s “anti-patient and anti-doctor” handling of the healthcare system’s near-ubiquitous billing and claims processing codes.
    • “Bill Cassidy, M.D., R-Louisiana, who chairs the Senate Health, Education, Labor and Pensions (HELP) Committee, chastised the nation’s leading physician association for “abusing” the Current Procedural Terminology (CPT) coding system and said he will be “actively reviewing” the issue.
    • “In a letter sent Monday but made public Wednesday, he accused the AMA of “charging exorbitant fees to anyone using the CPT code set, including doctors, hospitals, health plans and health IT vendors. These fees inevitably are passed on by CPT users to patients in the form of higher healthcare costs.”
    • “The letter includes requests for the AMA to detail how it incorporates provider feedback into its process for finalizing codes, and for specific details on revenues and spending related to CPT codes.”
  • The Wall Street Journal relates,
    • “The country’s top drugmakers are set to meet in early December at the Four Seasons hotel in Georgetown with Donald Trump Jr. and senior Trump administration officials that regulate the pharmaceutical industry.
    • “The host: BlinkRx, an online prescription drug delivery company that this year installed Trump Jr. as a board member. The summit will conclude with a dinner at the Executive Branch, the exclusive new club founded by Trump Jr. and his close friends, according to people with knowledge of the event and a copy of the invitation viewed by The Wall Street Journal. 
    • “BlinkRx stands to benefit from a shake-up of how patients buy drugs after President Trump urged pharmaceutical companies to sell their medicines directly to consumers. BlinkRx helps drugmakers do exactly that with a service that promises to set up direct-to-patient sales programs in as little as three weeks. TrumpRx, a new government website set to launch in early 2026, would funnel patients to direct-sale sites.”
  • Healthcare Dive informs us,
    • “The top lobby for pharmacy benefit managers has named Adam Kautzner, the head of major PBM Express Scripts, as chair of its board.
    • “As board chair, Kautzner will oversee the Pharmaceutical Care Management Association’s strategy, including defense of the drug middlemen amid growing scrutiny of their role in rising drug costs. 
    • “The PCMA has also created a new council to represent its mid-market clients, a segment of its membership that’s been growing, the lobby said Tuesday. The council will be represented by a new seat on the PCMA’s board to be held by Jeff Park, president of drug pricing platform Waltz Health.”

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “More than 10 years after bringing one of the first idiopathic pulmonary fibrosis (IPF) drugs to market, Boehringer Ingelheim is freshening up its leadership in the rare lung disease space with a newly approved treatment option.
    • “Jascayd’s Oct. 7 FDA approval makes it the first new therapy for IPF in more than a decade, following in the footsteps of the company’s own Ofev and Roche’s Esbriet, which won their respective FDA nods back in 2014. Together, those two medicines make up the current therapeutic market for IPF in the U.S. 
    • “With a tolerability edge over the older treatments and proven benefits in lung function, Boehringer’s new option could “shape the future of IPF treatment,” Martin Beck, head of the company’s inflammation disease area, told Fierce Pharma in an interview.”
  • BioPharma Dive adds,
    • “Lexeo Therapeutics on Tuesday said the Food and Drug Administration appears willing to review, and potentially approve, its experimental rare disease gene therapy more quickly than previously anticipated.
    • “According to the company, the agency has “indicated openness” to an accelerated approval filing for its treatment — a gene therapy called LX2006 for the neurodegenerative condition Friedreich’s ataxia — that’s based on pooled data from ongoing studies as well as results from a planned pivotal trial.”

From the judicial front,

  • Reuters reports,
    • “A federal appeals court on Monday rejected Novo Nordisk’s (NOVOb.CO) challenge to the U.S. government’s program that gives its Medicare health insurance plan the power to negotiate lower drug prices, the latest in a barrage of lawsuits brought by drugmakers to fail.
    • “The Philadelphia-based 3rd U.S. Circuit Court of Appeals affirmed a lower court’s ruling dismissing the Danish drugmaker’s challenge to the program and the Centers for Medicare and Medicaid Services’ selection of six of its insulin products for price negotiations.
    • “A unanimous three-judge panel rejected Novo’s constitutional challenges to the program, which was part of Democratic former President Joe Biden’s Inflation Reduction Act, and said the law specifically bars courts from reviewing the drugs selected.
    • “A Novo Nordisk spokesperson said the company was assessing its options to appeal the ruling.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “Today the Centers for Disease Control and Prevention (CDC) updated its measles data for the country, showing a total of 1,563 cases in 2025, an increase in 19 cases since last week. This is the most cases seen in the United States since 2000, the year measles was officially declared eliminated. 
    • “Twenty-seven percent of cases have been in children under the age of 5, and 92% of patients are unvaccinated or have an unknown vaccination status. CDC officials have confirmed 44 outbreaks, which account for 87% of confirmed infections.”
  • and
    • “An international team of researchers today reported promising results from a phase 1 trial of a novel vaccine designed to protect against typhoid fever and non-typhoidal Salmonella infections.
    • “The team, led by investigators from the University of Maryland (UM) School of Medicine, reported that the trivalent (three-strain) Salmonella conjugate vaccine (TSVC) produced a strong immune response, and was safe and well-tolerated, in a small group of healthy US adults. The findings from the trial were published today in Nature Medicine.
    • “The investigators say the findings are encouraging and provide a strong foundation for evaluating the vaccine in children. Typhoid fever and invasive non-typhoidal Salmonella (iNTS), which causes severe bloodstream infections, are leading causes of illness and death in children in Africa.
    • “A single vaccine that protects against both could be a game-changer for global pediatric health,” UM School of Medicine Dean Mark Gladwin, MD, said in a university press release.”
  • MedPage Today notes,
    • “Receipt of the 2024-2025 COVID-19 vaccine was associated with decreased risks of severe outcomes, according to an observational cohort study of U.S. veterans.
    • “Looking at COVID-associated outcomes in nearly 300,000 veterans at 6 months, the estimated vaccine effectiveness was 29.3% against emergency department visits, 39.2% against hospitalizations, and 64% against deaths, reported Ziyad Al-Aly, MD, of the VA St. Louis Health Care System, and colleagues.
    • “Overall, vaccine effectiveness for a composite of the three outcomes was 28.3%, with a risk difference per 10,000 people of 18.2 (95% CI 10.7-27.5), they noted in the New England Journal of Medicine.
    • “The severity of SARS-CoV-2 infections has waned since 2020, and uncertainty about the value of annual COVID shots helped drive down adult vaccination rates to 21% during the 2024-2025 season.”
    • “The severity of SARS-CoV-2 infections has waned since 2020, and uncertainty about the value of annual COVID shots helped drive down adult vaccination rates to 21% during the 2024-2025 season.”
  • The Washington Post lets us know how to stop the No. 1 killer of Americans long before any symptoms. Cardiovascular disease experts propose a new approach to treating heart disease, focusing on atherosclerosis prevention and early detection.
    • To improve your heart health, consider following the American Heart Association’s checklist, said Neha Pagidipati, a cardiovascular disease prevention expert with the American College of Cardiology.
    • The AHA’s “Life’s Essential 8” include:
      • Eating better. Recommendations include whole foods, lots of fruits and vegetables, lean protein, nuts, seeds, and using olive or canola oil for cooking.
      • Staying active.
      • Quitting tobacco and vaping.
      • Getting healthy sleep. For most adults, this is seven to nine hours of sleep each night.
      • Managing weight.
      • Controlling cholesterol. LDL, or “bad” cholesterol, should be 100 milligrams per deciliter or lower, Nissen said.
      • Managing blood sugar. If you have diabetes, pay attention to your hemoglobin A1C levels, which should be below 5.7 percent.
      • Managing blood pressure. For most people, blood pressure should be below 120/80, Nissen said.
  • Medscape adds,
    • “Many people with obesity have chronic pain due to joint stress and inflammation. Speaking to these patients about modifiable lifestyle factors — like diet and exercise — can help improve their pain severity and quality of life.
    • “In a new study published in the European Journal of Nutrition, patients with overweight or obesity who followed a 3-month weight-loss dietary intervention cut chronic musculoskeletal pain scores in half — independent of adiposity changes.”
  • NBC News reports,
    • “Short bursts of purposeful activity — such as walking around the block or lifting small weights — may be the best way to get in the habit of exercising. Bite-sized bits of exercise also improve heart and muscle fitness, a study published Tuesday in BMJ Sports Medicine found.
    • “Less than half of adults in the United States get enough aerobic activity and less than a quarter get the recommended amount of both aerobic and muscle-strengthening exercise. 
    • “When people are asked why they don’t exercise, the answers are almost always the same, no time and no motivation,” Miguel Ángel Rodríguez, a doctoral student in clinical research at the University of Oviedo in Spain, who led the study, said in an email.”
  • Per Health Day,
    • “Memantine improves social impairments in youth with autism spectrum disorder (ASD), according to a study published online Oct. 1 in JAMA Network Open.
    • “Gagan Joshi, M.D., from Massachusetts General Hospital in Boston, and colleagues examined the safety and efficacy of memantine for treating social impairments in youths with ASD in a 12-week placebo-controlled randomized clinical trial. The study population included 42 youths aged 8 to 17 years with ASD without intellectual disability who initiated treatment. The intention-to-treat efficacy analysis included 35 youths (16 treated with memantine and 19 with placebo).”
  • and
    • “More women are choosing to freeze their eggs, but fewer are returning to use them, according to a study published online Aug. 29 in the American Journal of Obstetrics & Gynecology.
    • “Mabel B. Lee, M.D., from the University of California, Los Angeles, and colleagues assessed national trends in planned oocyte cryopreservation, subsequent oocyte utilization, and outcomes of oocyte warming cycles. The analysis included data from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (2014 to 2021).”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Medical practice network OneOncology has acquired GenesisCare USA of Florida and is relaunching the practice as SunState Medical Specialists.
    • “The deal adds more than 100 physicians, including urologists, oncologists and surgeons, at 104 clinics throughout Florida to OneOncology’s portfolio, according to a Wednesday news release.
    • “GenesisCare USA of Florida was part of GenesisCare, an Australia-based cancer treatment provider that filed for Chapter 11 bankruptcy protection in 2023. The company, which was backed by private equity firm KKR and China Resources Capital, entered the U.S. in 2020 when it acquired 21st Century Oncology.
    • “As part of bankruptcy proceedings, GenesisCare sought to restructure with about $1.7 billion in debt and separate U.S. operations from those in Australia and Europe. It emerged from the bankruptcy process in 2024 and trimmed its U.S. footprint to Florida and North Carolina markets. 
    • “OneOncology, which is majority owned by TPG Capital, said the latest Florida deal builds on the company’s previous investments in urology. It plans to invest in upgraded technology at SunState Medical and expand access to clinical services such as advanced radiation therapies and interventional radiology, according to the release.”
  • BioPharma Dive tells us,
    • “Having closed a nine-figure fundraising round, a newly launched biotechnology company hopes to rewire the immune system with drugs aimed at a special kind of nerve cell.
    • “Nilo Therapeutics debuted Wednesday, equipped with $101 million from a Series A financing that was co-led by the venture capital firms DCVC Bio, Lux Capital and The Column Group. Alexandria Venture Investments and the Gates Foundation also contributed to the round.
    • “The fresh money, according to Nilo, will go toward growing the biotech’s research and development team, advancing its preclinical drug programs, and establishing laboratories in New York City. Nilo formed through a collaboration between The Column Group and three Ivy League scientists — Charles Zuker, of Columbia University; Ruslan Medzhitov, of Yale University; and Stephen Liberles, of Harvard University.”
  • Per Fierce Healthcare
    • “As pharma giant Eli Lilly builds out its direct-to-consumer care site, LillyDirect, the company has tapped virtual primary care company HealthTap to join its small lineup of independent care providers.
    • “Consumers who come to LillyDirect in search of specific treatments or Lilly-manufactured medications, such as GLP-1s, can find educational materials on common health conditions and access recommendations for in-person or virtual care. 
    • “LillyDirect has been building out its network of independent care providers for a slew of healthcare conditions and specialities, including diabetes, obesity, cancer, dermatology, autoimmune, sleep apnea and migraine.
    • “HealthTap will be listed as a provider for treating type 1 and type 2 diabetes on the LillyDirect site.”
  • and
    • “Allara Health, a virtual women’s health provider, has expanded to all 50 states. 
    • “The provider, specializing in women’s hormonal, metabolic and reproductive health, was in 30 states at the start of the year. Alongside news of the expansion, Allara has also published clinical outcomes data that demonstrate improvements in patient health in a health impact report.
    • “The retrospective analysis included nearly 1,500 patients who either had a PCOS diagnosis or were being seen for other hormonal or metabolic care. It found that in the first nine months of care, patients with a body mass index (BMI) in the obese range (equal to or greater than 30) achieved a 5% mean BMI reduction. A 5% weight reduction is considered clinically significant, the report said.
    • “The analysis also found that after 10 months, two-thirds of prediabetic patients had normalized their A1C levels, and 77% of diabetics reduced their A1C levels out of the diabetic range. Patients with a high level of insulin resistance saw a 12% reduction in those levels.” 
  • and
    • “Amazon Pharmacy is rolling out kiosks stocked with prescription medications to help patients get their meds immediately after appointments. 
    • “The kiosks will launch across One Medical locations in Los Angeles starting December 2025. Expansion to additional One Medical offices is expected soon after. The kiosks will contain commonly prescribed meds like antibiotics, inhalers and blood pressure medications. Controlled substances and medications requiring refrigeration are not available.” 

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “The partial government shutdown rolled on Thursday with both sides dug in and President Donald Trump using the funding lapse as an excuse to cut billions of dollars in “dead wood,” as he put it, throughout the executive branch.
    • “Trump said in a social media post that he’d meet with Office of Management and Budget Director Russ Vought to go over “which of the many Democrat Agencies” should be cut as the GOP seeks to make the shutdown more painful for Democratic leaders.
    • “Neither chamber had votes on Thursday as lawmakers observed the Yom Kippur holiday, with the House not returning until Tuesday. The Senate will get another opportunity to vote Friday at 1:30 p.m., but there were no signs of a bipartisan breakthrough yet.
  • Beckers Hospital Review tells us what the Centers for Medicare and Medicaid Services (“CMS”) said will and won’t continue during a lapse in appropriations. Here’s what will continue:
    • “CMS said it will have sufficient funding for Medicaid to fund the first quarter of fiscal 2026, which runs through Dec. 31. 
    • “The agency will maintain the staff necessary to make payments to eligible states for the Children’s Health Insurance Program.
    • “Federal marketplace activities will continue, including eligibility verification.
    • “Other non-discretionary activities, including Health Care Fraud and Abuse Control and the Center Medicare & Medicaid Innovation will also continue. 
  • You can look at the article to find out what’s not continuing.
  • Avalere Health points out that “Part D Choices Continue to Shrink with Fewer PDPs in 2026.”
    • “The Part D market will contract even further in 2026, with a 22% decrease in standalone PDP options and a 9% decrease in non-SNP MA-PDs.”
    • SNP MA-PDs are a type of Medicare Advantage plan for people who are eligible for both Medicare and Medicaid.
  • The American Medical Association News relates,
    • “The Centers for Medicare & Medicaid Services Sept. 30 issued a memo, through the Health Plan Management system, finalizing the Medicare Advantage Utilization Management Annual Data Submission requirements for MA organizations. CMS has limited the scope of the annual data collection to internal coverage criteria for MA services — including Medicare Part B drugs — that require prior authorization. Criteria used exclusively for other review types, such as concurrent or payment reviews, will not be collected. CMS decided not to finalize the proposed audit protocol and corresponding audit tools, citing concerns about duplicative audits, but may consider incorporating review of internal coverage criteria into future program audits.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • The FDA approved a new generic version of the abortion pill mifepristone, a 200-milligram oral tablet, from Evita Solutions.
    • The FDA’s approval of the generic mifepristone comes as the Department of Health and Human Services reviews the drug’s safety.
    • Antiabortion lawmakers and groups criticized the approval, while abortion-rights groups emphasized the drug’s safety and effectiveness.
  • BioPharma Dive adds,
    • “The Food and Drug Administration, already reeling from layoffs and leadership changes under the Trump Administration, warned that the government shutdown will delay or pause important work at the agency.
    • “In a memo released before the shutdown began, the FDA said it expects to retain 86% of its staff, or 13,872 employees. The agency can continue reviewing existing applications for products, including drugs and medical devices that are funded by user fees, but will not be able to accept new submissions. 
    • “The FDA will also stop many regulatory activities that don’t address “imminent threats to the safety of human life.” For instance, food safety efforts will be reduced during the shutdown, and the agency won’t be able to support much of the work done to protect Americans from unsafe and ineffective compounded drugs, the FDA said.”
  • MedTech Dive notes,
    • “The Food and Drug Administration has released a list of the medical device guidance documents that it plans to develop or publish in its 2026 financial year.
    • “The agency said Tuesday that its top priorities include the finalization of guidance on the use of real-world evidence to support regulatory decisions and on predetermined change control plans for medical devices. 
    • “Three of the FDA’s four priority draft guidance documents are holdovers from the 2025 list. Like last year, the FDA has listed guidance on air purifying respirators and menstrual products among its top draft document priorities for 2026.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “In its latest weekly update [Wednesday], the US Centers for Disease Control and Prevention (CDC) reported 30 more measles cases, putting the national total at 1,544, a record high since the United States eliminated the disease in 2000.
    • “Two more outbreaks were reported, bringing the total to 42. The CDC said 86% of cases are linked to outbreaks, and 92% of patients are unvaccinated or have an unknown vaccination status. The number of affected jurisdictions remained the same, at 42. 
    • “So far, 21 cases have been reported in international visitors.”
  • The American Medical Association lets us know what doctors wish patients knew about vitamins and supplements.
  • Beckers Hospital Review notes,
    • “Nursing homes in Vermont and Wyoming had the highest percentage of residents experiencing one or more falls with major injury between April 1, 2024, and March 31, 2025, according to CMS data published Sept. 24. 
    • “The District of Columbia and California had the lowest percentage for the same time period. 
    • “A recent HHS report found that nursing homes fail to report 43% of falls that resulted in major injury and hospitalization among Medicare-enrolled residents.
    • “The national percentage of nursing home residents experiencing one or more falls with major injury was 3.28%.” 
  • CNN relates,
    • “A new report ranks US states on rates of mental well-being and mental health care, and New York, Hawaii and New Jersey have outperformed the rest — in that order.
    • “The 2025 State of Mental Health in America report sizes up how all 50 states and Washington, DC, fared on 17 measures of mental health in 2022 and 2023, according to Mental Health America, which published the report on Wednesday. The nonprofit promotes mental health and illness prevention through education, research and advocacy.
    • “The 17 factors mainly concern adults and youth who experienced mental illness, suicidal thoughts or substance use disorder in the past year; adults and youth who didn’t receive necessary treatment, couldn’t afford it or were uninsured; people with insurance that didn’t cover mental or emotional problems; and the availability of mental health providers.
    • “Nevada had the worst rating, followed by Arizona and Alabama — marking the second time Nevada and Arizona have ranked the lowest, “underscoring a high need for strategic investment in mental health in these states,” MHA said in a news release.”
  • NBC News reports
    • “People who learn they have autism after age 6 — the current median age at diagnosis — are often described as having a “milder” form of autism than people diagnosed as toddlers.
    • “A new study challenges that assumption.
    • “A genetic analysis finds that people with autism spectrum disorder diagnosed in late childhood or adolescence actually have “a different form of autism,” not a less severe one, said Varun Warrier, senior author of a study published Wednesday in Nature.
    • “The “genetic profile” of people with late-diagnosis autism actually looks more like depression, attention-deficit/hyperactivity disorder and post-traumatic stress disorder than early childhood autism, said Warrier, an autism researcher at the University of Cambridge. 
    • “The study illustrates that autism is not a single condition with one root cause, but rather an umbrella term for a cluster of conditions with similar — although not identical — features, said Geraldine Dawson, founding director of the Duke Center for Autism and Brain Development, who wasn’t involved in the new report.”
  • STAT News adds,
    • “Researchers have found that patients with amyotrophic lateral sclerosis have autoimmune responses, a finding with the potential to reshape how scientists think of the devastating and complex neurologic disorder.
    • “A team led by scientists at La Jolla Institute for Immunology analyzed blood samples from 40 ALS patients and 28 people without the disease. They found that those with ALS had on average stronger immune cell responses than healthy controls to C9orf72, a protein active in neurons and associated with the rare condition. Other proteins linked to ALS, however, were not preferentially targeted by patients’ immune systems.
    • “The authors discovered that, among patients with responses against C9orf72, those with immune cells that produced signals known to tamp down inflammation were predicted to have longer survival times than ALS patients with more inflammatory responses.
    • “The findings, published in the journal Nature on Wednesday, suggest to Samuel Pfaff, an ALS researcher at the Salk Institute, that there is an autoimmune component to the disease. That’s something previous studies have suggested but have not conclusively shown. The results raise the possibility that researchers could one day treat ALS patients in new ways by targeting their immune system, and that scientists might monitor disease progression by tracking autoimmune cells.
    • “I think it’s giving us a greater appreciation of a variety of aspects of the disease,” said Pfaff, who was not involved in the study. “It is providing some new thinking about how to consider treating the disease.”
  • and
    • “Researchers have shut pregnant women out of gold-standard clinical trials in order to protect them and their babies. But the practice has had the opposite effect.
    • “Instead, women have to wade through a chaotic data landscape, and many may choose to suffer through untreated illnesses. 
    • “Besides sowing confusion, the lack of data makes it easier for people to obfuscate and misconstrue existing data. That dynamic was on full display last week as President Trump and Health and Human Services Secretary Robert F. Kennedy Jr. urged pregnant women to avoid Tylenol as they claimed, without clear evidence, that the active ingredient acetaminophen causes autism. 
    • “The existence of this data gap is well established. But it’s gained new relevance as federal officials zero in on the medical decisions of pregnant women, searching for evidence of harm to fetuses.” 
  • Per Health Day,
    • “The early warning signs of multiple sclerosis appear to be the same for everyone, regardless of their background.
    • “The pain, mood changes, brain decline and neurological problems associated with early MS can appear years before diagnosis but appear to affect all types of people in similar ways, according to a new study.
    • “Our study shows that the very earliest features of MS are similar regardless of someone’s ethnic or socio-economic background,” said researcher Ben Jacobs, a clinical lecturer in neurology at Queen Mary University of London.
    • “Efforts to detect MS earlier or identify people at high risk should therefore be inclusive and representative of the whole population,” Jacobs said in a news release.” * * *
    • “The new study appeared Sept. 24 in the Annals of Clinical and Translational Neurology.”
  • Per BioPharma Dive,
    • “Amgen’s cholesterol-lowering shot Repatha met its main goals in a large trial evaluating use as a “primary prevention” therapy, besting a placebo at reducing the risk of cardiovascular events or death in people who’d never had a heart attack or stroke, the company said Thursday.
    • “Repatha, a so-called PCSK9 inhibitor, is currently available as a “secondary prevention” therapy for those with a history of heart disease and at high risk of experiencing another. Though it’s sometimes also used “off-label” in the much larger primary prevention setting, an approval backed by the latest study results — which Amgen referred to as a “landmark” finding — could substantially widen use. 
    • “Once forecast to achieve tens of billions of dollars in annual sales, Repatha has fallen short of those lofty projections amid pushback from insurers and a modest benefit in those with established heart disease. Still, sales surpassed the $1 billion mark in 2021 and have grown since. The Food and Drug Administration also recently expanded use in those at higher risk of major cardiovascular events.”
  • The New York Times reports,
    • “Jane Goodall, who died on Wednesday at the age of 91, followed several principles that geriatricians recommend for a long and healthy life.
    • “A scientist, conservationist and author, Dr. Goodall stayed active, working until the day she died. She had a clear sense of purpose for her life. And she was an enduring optimist.
    • “Over a nearly seven-decade career, Dr. Goodall taught us about the intelligence of chimpanzees. But she left behind powerful teachings about aging — and living well — too.”
      • “Her work kept her active.”
      • “She had a ‘reason for being.’”
      • “She maintained a positive outlook on life.”

From the U.S. healthcare business front,

  • Beckers Payer Issues lets us know,
    • “Despite Cigna launching its downcoding policy on Oct. 1, the insurer is temporarily holding off on implementing it for California HMO plans, according to the California Medical Association and Cigna.
    • “The policy allows Cigna to adjust some higher-level evaluation and management codes if they do not meet certain complexity standards. Codes 99204-99205, 99214-99215 and 99244-99245 fall under this policy. After receiving questions over its legality, the reimbursement policy is awaiting review by the California Department of Managed Health Care.
    • “This approach also introduces avoidable friction with physician practices into the process, erodes trust between providers and plans, and exacerbates the challenges of delivering high-quality care in a resource-constrained environment,” the California Medical Association wrote in a letter to Cigna.
    • “Our new policy that ensures the limited number of impacted physicians are reimbursed appropriately for E/M services took effect as planned, with the exception of California HMO plans regulated by the state Department of Managed Health Care,” a Cigna spokesperson told Becker’s. “We anticipate that the policy will also take effect for these plans’ claims in California after the DMHC completes its review of the additional information that we have provided.”
  • Beckers ASC Review adds,
    • “On Oct. 1, a new UnitedHealthcare policy went into effect, cutting reimbursements to certified registered nurse anesthetists by 15%. 
    • “The policy update was issued on July 1 and applies to claims for anesthesia services rendered by CRNAs practicing independently. For claims billed under the QZ modifier — those rendered by CRNAs — the provider will now receive 85% of the allowable. 
    • “CRNAs in Arkansas, California, Ohio, Colorado, Hawaii, Massachusetts, New Hampshire and Wyoming are exempt from the new reduction. 
    • “The update has drawn criticism from the American Association of Nurse Anesthesiology, who told Becker’s in an Oct. 1 email that the policy “threatens patient care” and could lead to delayed procedures and strained access to care, particularly in rural and underserved communities where CRNAs are more heavily utilized for anesthesia services. 
    • ‘The AANA also claims the policy is in violation of a provider nondiscrimination provision outlined in the ACA. The organization has also written a coalition letter urging the secretaries at the Department of Labor, HHS and Department of Treasury to investigate and prohibit commercial payers from violating this nondiscrimination provision.”
  • The Healthcare Cost Institute tells us what preventive care costs.
  • STAT News reports,
    • “UnitedHealth Group has tapped a Duke University artificial intelligence expert to be its chief AI scientist as the health care giant ramps up the use of the technology across its sprawling network of businesses, according to a memo obtained by STAT.
    • “Michael Pencina, chief data scientist for Duke Health, stepped down from his role at Duke on Wednesday to take the job at UnitedHealth, according to the memo from Mary Klotman, dean of the Duke University School of Medicine.”
  • Per Modern Healthcare,
    • “Providence finalized Wednesday the second phase of a joint venture with Compassus to manage the health system’s home care operations in California.
    • “Under the terms of the deal, Compassus will manage approximately 20 home health, hospice, personal home care and palliative care locations under the name Providence at Home with Compassus.
    • “The deal is part of a broader initiative Renton, Washington-based Providence inked with Compassus last year to operate home care locations across Alaska, Texas, Washington, California and Oregon. Compassus began managing 14 locations in Alaska, Texas and Washington in March.”
  • Per Fierce Healthcare,
    • “NeueHealth officially ceased trading on the New York Stock Exchange after completing its go-private deal with an affiliate of New Enterprise Associates.
    • “The company, once known as Bright Health Group, was scooped up on Thursday by the NEA unit with an enterprise value of about $1.5 billion, following a series of financial struggles. Common stockholders in NeueHealth will receive $7.33 per share as part of the sale, according to an announcement.
    • “Certain shareholders in the company—including New Enterprise Associates and 12 other investors who hold all of its preferred stock—will instead enter into a rollover agreement, where they will exchange shares for equity interest in the now-private enterprise.
    • “In addition, NeueHealth’s leadership will continue in their roles and have similarly rolled their holdings into equity in the private company.”
  • and
    • “Startup SpotitEarly is pioneering an innovative early cancer screening test based on breath samples and powered by artificial intelligence and the strong scent detection of trained dogs.
    • “SpotitEarly launched in the U.S. market in May, armed with $20 million in funding. The company, initially founded in Israel, plans to roll out its breath-based, at-home early detection test in the U.S. next year. It’s preparing for an FDA pre-submission as part of a phased regulatory strategy, executives said.
    • “New Jersey-based Hackensack Meridian Health is teaming up with the startup to validate its non-invasive approach to early cancer detection.
    • “As part of the research collaboration, SpotitEarly will work with the Hennessy Institute for Cancer Prevention and Applied Molecular Medicine, part of the Hackensack Meridian John Theurer Cancer Center, and Hackensack University Medical Center.”
  • Beckers Hospital Review relates,
    • “Eight states tied for having the lowest rates of patients who left hospital emergency departments without being seen, at 1%, CMS data showed.
    • “CMS’ Timely and Effective Care dataset, updated Aug. 6, tracks the percentage of patients who left an ED before being seen between January and December 2023. The measures apply to children and adults treated at hospitals paid under the inpatient or the outpatient prospective payment systems, as well as hospitals that voluntarily report data on relevant measures for Medicare, Medicare-managed care and non-Medicare patients. Averages include data for Department of Veterans Affairs and Defense Department hospitals. Read the methodology here. 
    • “The national average showed 2% of patients left EDs before being seen in 2023. This is returning to prepandemic levels, after the rate went up to 3% in 2022.”