Friday Report

CDC

Friday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–

Happy Halloween!!

From Washington, DC

  • The Wall Street Journal reports,
    • “President Trump’s demand that Republican senators bypass Democrats to reopen the federal government risked upsetting delicate negotiations on Capitol Hill, where lawmakers were finally making progress toward a deal to end the monthlong impasse and head off more pain for American households. 
    • “Optimism had been growing among Republican and Democratic senators involved in talks over recent days, with hopes that a resolution could be reached in the week ahead, people familiar with discussions said. 
    • “But Trump’s new demand in a social-media message late Thursday to eliminate the Senate filibuster rule could complicate the path forward. Meanwhile, food aid is at risk of lapsing for millions of people, the nation’s airports are increasingly snarled, and Affordable Care Act health-plan enrollees are confronted with sharply higher premiums.”
  • Time will tell.
    • “In remarks Friday on his way to Florida, Trump didn’t mention his filibuster demand but reiterated that he was willing to talk with Democrats if they would provide votes to reopen the government. 
    • “Let them open up the country, and we’ll meet,” he said. “It’s so easily solved.” 
    • “A White House spokeswoman said that if Democrats don’t work with Republicans to reopen the government, then the “nuclear option” of ending the filibuster will need to be used.
    • “Senate Republicans are set to return to Washington on Monday night to face a loyalty test on whether they will side with Trump on killing the filibuster or try to seal the deal with bipartisan talks. 
    • “Senate Majority Leader John Thune (R., S.D.) has pledged to protect the longstanding rule. A spokesman said Friday that his position hadn’t changed.”
  • Tammy Flanagan, writing in Govexec, tells us “what federal employees need to know about Medicare enrollment.” She provides “an updated guide to timing, parts, costs and coordination so you don’t get stuck with penalties or surprises at 65.”
  • OPM announced on October 30, 2025,
    • “two new online tools designed to make retirement services faster, and easier for federal retirees. These improvements are part of OPM’s broader effort to modernize its Retirement Services operations and enhance the customer experience through expanded self-service options. Beginning today, retirees can:
      • “Securely download their 1099-R tax forms without logging into Retirement Services Online, offering a faster, paperless option for accessing tax documents.
      • “View current retirement processing times to better understand the expected timeline for the completion of their retirement benefit applications.
    • “These new self-service tools are another step toward delivering the efficient, transparent, and customer-focused experience federal retirees deserve,” OPM Director Scott Kupor said. “By expanding digital access and improving automation, we’re giving retirees more control over their information and freeing up our team to focus on complex cases that require extra care.”
  • Healthcare Dive informs us,
    • “Federal regulators have greenlit eight drugmaker proposals to enact rebates in 340B, upending how savings in the massive drug discount program are normally divvied out to providers.
    • “The approvals were disclosed by the Health Resources and Services Administration, the HHS agency that oversees 340B, on Thursday. They include frequently prescribed drugs manufactured by companies like Bristol Myers Squibb and Johnson & Johnson, two drugmakers that sued the government after it blocked them from implementing their own 340B rebate plans.
    • “Hospital groups slammed the model approvals as benefiting drugmakers at their expense, with America’s Essential Hospitals calling it a “clear case of the fox guarding the hen house.”
  • Roll Call adds,
    • “Lawmakers impatient with the lack of progress on a key health care issue — the long-debated need for changes to what’s known as the 340B drug pricing program — say they are closing in on legislation aimed at what they say are abuses in the program.” * * *
    • “Lawmakers argue the program incentivizes practices that drive up health care costs. A report released last month by the Congressional Budget Office found the program’s design encourages prescription of higher-cost drugs and promotes increased vertical integration among facilities.
    • “When 340B hospitals acquire or open new outpatient clinics, such as infusion centers or specialty medicine practices, those clinics also become eligible for the program. Critics say the hospitals collect discounts on drugs offered at those clinics and then sell them at full price to insured patients.
    • “Our goal is to make health care more affordable, but 340B is making employer-sponsored insurance, which pays for the health care for 150 million people, less affordable,” Senate HELP Chair Bill Cassidy, R-La., said.” * * *
    • The [rebate] pilot [mentioned above] could increase pressure on Congress to pass 340B legislation after debating it for several years, said Darbin Wofford, deputy director of health care for Third Way’s economic program. But action is doubtful with Congress in the throes of a government shutdown.
    • “It’s unlikely we see movement for any 340B policy in Congress this year, but there are opportunities next year and in the following Congress,” Wofford said.
  • The American Hospital Association News reminds us,
    • “Individuals and families can enroll in or change their health coverage options through the Health Insurance Marketplace beginning tomorrow through Jan. 15. The AHA offers resources to help people choose the best coverage for themselves and their families.”  
  • Beckers Payer Issues points out six things to know about this ACA marketplace open enrollment period.

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Seven new illnesses and two additional deaths have been reported multistate Listeria outbreak tied to prepared pasta meals, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) said yesterday in updates.
    • “A total of 27 people in 18 states have been infected with the outbreak strain of Listeria monocytogenes, with 25 hospitalizations and 6 deaths. One pregnancy-associated infection resulted in fetal loss. Deaths have been reported in Hawaii, Illinois, Michigan, Oregon, Texas, and Utah.
    • “The illness-onset dates range from August 6, 2024, to October 16, 2025. Patient ages range from 4 to 92 years, with a median age of 74 years. Two thirds of patients are women.”
  • The Washington Post reports,
    • “Most children should not receive prescription fluoride, Food and Drug Administration officials said Friday as they announced measures to restrict sales of the cavity-fighting drug.
    • “The agency said children under 3 and older children not at high risk for tooth decay should avoid ingestible fluoride, which is often sold as tablets or drops. It sent letters to manufacturers warning them not to market the products to such children.
    • “Fluoride tablets are often prescribed to children who live in communities that do not put the tooth-strengthening mineral in its water supply. But Health Secretary Robert F. Kennedy Jr. has led the Trump administration’s efforts to crack down on fluoride, including revisiting the decades-old recommendation from the Centers for Disease Control and Prevention to fluoridate water.“ * * *
    • “The American Dental Association recommends prescription fluoride to children ages six months and older who are considered high risk for tooth decay and have little fluoride in their drinking water. 
    • “Scott Tomar, a spokesman for the ADA on community water fluoridation, said the FDA recommendations were not too different then the association’s guidance.”

From the judicial front,

  • Govexec relates
    • In a lawsuit filed in Delaware Chancery Court, Pfizer said Novo Nordisk’s offer can’t be considered superior because it isn’t reasonably likely to be completed on the terms proposed.,
    • “A federal judge in Boston ruled Friday that the U.S. Department of Agriculture’s plan to pause a food assistance program for 42 million people was illegal — but gave the Trump administration until Monday to respond to her finding before she decides on a motion to force the benefits be paid despite the ongoing government shutdown.
    • “At nearly the same time Friday, a Rhode Island federal judge in a similar case brought by cities and nonprofit groups ordered USDA to continue payments and granted a request for a temporary restraining order.
    • “In Massachusetts, in a Friday afternoon order, District Court of Massachusetts Judge Indira Talwani said she would continue to take “under advisement” a coalition of Democratic states’ request to force the release of funds from a contingency account holding about $6 billion.
    • “Her ruling came a day before a cutoff of Supplemental Nutrition Assistance Program, or SNAP, benefits to low-income households [due to the government shutdown].”
  • The Wall Street Journal reports,
    • “Drugmaker Pfizer on Friday sued obesity-drug developer Metsera and Novo Nordisk, seeking to block Metsera from terminating its multibillion-dollar merger deal with Pfizer after Novo Nordisk made an unsolicited takeover bid.
    • “In a lawsuit filed in Delaware Chancery Court, Pfizer said Novo Nordisk’s offer can’t be considered superior because it isn’t reasonably likely to be completed on the terms proposed.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership lets us know,
    • “Respiratory syncytial virus activity is starting to tick up across the country, marking the start of virus season, according to data tracked by epidemiologists and public health experts. 
    • “Routine CDC tracking on respiratory virus trends is on pause amid the federal government shutdown, now approaching its fifth week. However, data from the PopHIVE project at Yale School of Public Health in New Haven, Conn., shows that ED visits for RSV among children under 4 are on the rise.” 
  • Per Medscape,
    • “Impaired glymphatic function — the brain’s waste clearance system — could help explain how cardiovascular disease (CVD) risk factors may drive dementia. 
    • “In a large UK Biobank study, MRI markers of disrupted cerebrospinal fluid (CSF) and glymphatic flow predicted future dementia and were closely linked to vascular risk factors, including high blood pressure, diabetes, smoking, and arterial stiffness.
    • “Discovered just over a decade ago, the glymphatic system depends on the efficient circulation and drainage of CSF. When this process is impaired, the brain’s ability to clear amyloid, tau, and other toxins diminishes, potentially accelerating the development of dementia.
    • “The study shows, with very convincing data, that these markers predict dementia risk, and also that the markers relate to cardiovascular risk factors,” study author Hugh S. Markus, MD, professor of stroke medicine in the Department of Clinical Neurosciences, University of Cambridge, UK, told Medscape Medical News.
    • “This offers a novel way in which one might be able to target or treat dementia. If one could improve glymphatic flow, one could then reduce the risk of dementia.”
  • The Wall Street Journal reports,
    • “Parkinson’s disease is the fastest-growing neurodegenerative disease in the world. But it’s also one of the most preventable, according to Dr. Ray Dorsey, neurologist at Atria Health and Research Institute in New York and co-author of a new book, “The Parkinson’s Plan: A New Path to Prevention and Treatment.”
    • “A progressive nervous-system disorder, Parkinson’s primarily impacts movement. As dopamine-producing brain cells die, movement becomes affected, resulting in tremors, muscle stiffness, slowed movement and impaired balance.
    • “Some doctors like Dorsey say most cases appear to be caused by environmental factors. A study in the journal Brain last year found that only 13% of Americans carry a genetic risk factor for the disease. 
    • “The vast majority of Americans have no known genetic cause or risk factor for their disease,” says Dorsey. “So the principal cause of disease lies not with us, but outside of us, in our environment, in chemicals in our food, water and air.”
    • “Other doctors say conversations about preventing Parkinson are missing the mark.
    • “We’re very much oversimplifying if we say, ‘If we just get rid of that particular pollutant we are going to prevent Parkinson’s,’ ” says Dr. Brad Racette, chair of neurology and senior vice president at Barrow Neurological Institute in Phoenix. “We will probably have a measurable effect on the number of cases, but I think the key message is it’s not as simple as a single pollutant is causing an individual’s Parkinson’s.”
    • The article “offers some of the ways that doctors like Dorsey recommend to potentially reduce your risk of developing Parkinson’s disease.” For example
      • “Research the area near your home. Try not to move to an area near a golf course or Superfund site. A May JAMA Network Open study found that people who live within one mile of a golf course have a 126% increased risk of developing Parkinson’s.
      • “Superfund sites aren’t well marked, but you want to avoid living too close to one since toxic chemicals leak into the soil and eventually the surrounding air. The Environmental Protection Agency has a database to search for sites and environmental firms can test your air.”
  • Per MedPage Today,
    • “Moderate exercise of about 17 metabolic equivalent task (MET)-hours per week significantly reduced the risk of digestive system cancers (DSCs) and DSC mortality.
    • “Optimal risk reduction occurred at about 50 MET-hours per week.
    • “After factoring in consistency, physical activity equivalent to 16.9 MET-hours/week had the same effect on DSCs as 50 MET-hours/week.”
  • Here is a link to an MET calculator.
  • Per BioPharma Dive,
    • “Tucked into its latest earnings report, Eli Lilly disclosed that it has removed from its research pipeline an experimental drug for pain.
    • “The drug, which Lilly in-licensed several years ago, works by inhibiting a protein called P2X7. This protein helps regulate molecules that trigger inflammation and amplify pain signals. Blocking P2X7, Lilly had hoped, would be an effective way to treat conditions like osteoarthritis, chronic lower back pain and the nerve pain that often accompanies diabetes.
    • “However, data from mid-stage tests “did not meet our high internal bar for success,” according to Lilly spokesperson Ashley Hennessey. While the company is “assessing next steps for the program, including possible additional indications,” for now, the drug is out of its pain pipeline.
    • “It’s at least the second Lilly pain program to get axed this year. A drug named mazisotine, designed to boost a pain-relieving protein known as SSTR4, was shelved this summer.”

From the U.S. healthcare business front,

  • Per Fierce Pharma,
    • “For the third straight quarter, AbbVie has jacked up its revenue forecast for 2025. The Illinois drugmaker has raised its guidance by $400 million, now expecting sales to reach $60.9 billion.
    • “The estimate is $1.9 billion higher than AbbVie’s projection from the start of the year, another indication that the company continues to be surprised by the performance of immunology stalwarts Skyrizi and Rinvoq and that it has rebounded from the 2023 loss of patent protection in the United States for Humira, the first drug ever to generate more than $20 billion in annual sales.
    • “Clearly, the momentum is there,” AbbVie CEO Rob Michael said on a Friday conference call. “We’ve beaten and raised in every quarter in 2025.”
    • “The new forecast reflects expectations that Skyrizi sales will reach $17.3 billion in 2025, which is a $200 million increase from AbbVie’s previous estimate based on the drug’s market share gains in psoriasis and inflammatory bowel disease (IBD), chief financial officer Scott Reents said.”
  • and
    • “For the last several quarters, Gilead Sciences’ earnings calls have been colored by anticipation for the launch of the California drugmaker’s long-acting HIV pre-exposure prophylaxis (PrEP) option. This week, Gilead had a chance to share some early returns on the med’s market debut after its FDA approval five months ago.
    • “Since Yeztugo’s U.S. launch in June, the drug has garnered $54 million in sales, Gilead reported on Thursday, with $39 million generated specifically during the third quarter. The company has already secured 75% U.S. payer access for Yeztugo, some three months ahead of its original targeted timeframe of six months post-launch, with 90% expected by the end of the first half of 2026, Gilead said in its third-quarter earnings presentation (PDF). 
    • “Gilead expects $150 million to come from Yeztugo this year, but Citi analysts call this guidance “conservative,” citing broad update and rapid payer coverage as “hallmarks of a strong launch” that the drug has already demonstrated, the analysts wrote in a note to clients. 
    • “On the flip side, Mizuho analysts note that the Yeztugo’s quarterly haul was a “slight miss.”
  • Radiology Business reports,
    • “Hospital giant Intermountain Health has reached a deal to acquire a nearly 40-year-old private radiology practice in Las Vegas, the two announced Thursday. 
    • “The Salt Lake City-headquartered nonprofit is buying Steinberg Diagnostic Medical Imaging for an undisclosed sum, with the integration taking place sometime after Jan. 1. SDMI opened its first office in 1988 and today commands a team of over 550 employees and affiliates, including approximately 30 radiologists. 
    • “Intermountain is growing in southern Nevada and believes adding SDMI and its 12 outpatient imaging centers will help “enhance patient access to high-quality, cost-effective care.” Acquiring the practice also will allow the hospital system to provide more “coordinated and integrated imaging,” said Eric Liston, chief clinical shared services officer. 
    • “As the number of people with chronic and complex health conditions continues to grow, ease of access to high-quality imaging services is more important than ever,” he said in a statement Oct. 30.”
  • Per Fierce Healthcare,
    • “Elevance Health’s Anthem plans are cracking down on hospitals or outpatient facilities that offer services using out-of-network providers.
    • “Beginning Jan. 1 in 11 states, Anthem will impose an administrative penalty equal to 10% of the allowed amount on a facility’s claims that include out-of-network providers. These facilities will also be at risk of termination from Anthem’s provider network, per a notice from the insurer sent out earlier this month.
    • “Ariel Bayewitz, vice president of health economics at Elevance Health, told Fierce Healthcare in an interview that the policy was designed in response to provider behavior under the No Surprises Act (NSA) independent dispute resolution (IDR) process. He said the insurer has seen a consistent pattern of IDR being used as a “back-door payment channel” for pricey, nonemergent procedures.” FEHBlog note — Smart move.
  • and
    • “Online therapy provider Talkspace reported another strong quarter with 25% revenue growth, driven by its expanding payer business, with net income of $3.3 million, up 73% from the same period in 2024.
    • “The company brought in $59.4 million in revenue in Q3, driven by a 42% year-over-year increase in payer revenue, or insurance-covered sessions, to reach $45 million. Talkspace’s direct-to-consumer business, however, continued to decline, with $4.6 million in revenue, down 23% year-over-year. The company’s direct-to-enterprise revenue was $9.3 million, down 1% year-on-year.
    • “The company reported adjusted EBITDA of $5 million, an improvement from $2.4 million adjusted EBITDA in the third quarter of 2024.
    • “The company completed 432,000 insurance-covered mental health sessions in Q3, up 37% year-over-year, and active payer members increased 29% in Q3 to 129,000, Ian Harris, Talkspace’s chief financial officer, said during the company’s third-quarter earnings call.“
  • Per Healthcare Dive,
    • “Healthcare executives see digital health and virtual care as key technologies to improve patient experience, but determining returns from these investments is unclear, according to a survey published this week by healthcare consultancy Sage Growth Partners.
    • “Nearly 60% of respondents said their health system offered virtual primary care and remote patient monitoring. Additionally, half said they offered telehealth for stroke care. 
    • “But fewer than 30% earned significant ROI from most of their virtual care offerings, according to the survey. Plus, many executives said they would need to invest funds to shift to a new virtual care platform in the next few years.” 

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.”

Friday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, No Surprises Act, Obesity, U.S. Healthcare, Uncategorized–

From Washington DC

  • The Wall Street Journal reports,
    • “Lawmakers are exploring options to end the government shutdown or mitigate its impact on federal workers and lower-income households.
    • “Some Republicans are considering stand-alone measures to pay specific groups of workers or fund certain programs during the shutdown.
    • “Democrats are facing increased pressure from constituents to end the shutdown, despite their stance on healthcare spending and federal workers.”
  • and
    • “The Pentagon said it received a $130 million donation from an anonymous private donor to cover military salaries during the government shutdown.
    • “The donation was accepted under the Defense Department’s “general gift acceptance authority” and is designated for servicemembers’ pay and benefits.
    • “President Trump announced the donation, calling the unnamed benefactor a “patriot,” as military members faced missing paychecks.”
  • Healthcare Dive tells us,
    • “Senators on both sides of the aisle expressed support for reforming the 340B drug discount program during a Thursday hearing of the Health, Education, Labor, and Pensions Committee — though lawmakers also cautioned that a careful approach is needed to ensure changes don’t harm rural hospitals and health centers.
    • “The hearing centered around concerns that 340B, although well-intentioned, has grown too large and may not ultimately benefit patients.” * * *
    • “Efforts are being led by a bipartisan working group formed in March, comprised of Sens. Jerry Moran, R-Kan.; Tammy Baldwin, D-Wis.; Shelley Moore Capito, R-W.V.; Tim Kaine, D-Va.; Markwayne Mullin, R-Okla.; and John Hickenlooper, D-Colo.” 
  • Per a Social Security news release,
    • “Social Security benefits and Supplemental Security Income (SSI) payments for 75 million Americans will increase 2.8 percent in 2026. On average, Social Security retirement benefits will increase by about $56 per month starting in January.
    • “Over the last decade the cost-of-living adjustment (COLA) increase has averaged about 3.1 percent.  The COLA was 2.5 percent in 2025.”
  • CMS announced today that “The Federal IDR Team released updates to the Federal IDR Portal’s Notice of IDR Initiation web form to improve the duplicate dispute validation process.” Duplicate arbitration requests were one on the principal concerns raised by the AHIP/BCBSA NSA survey noted in yesterday’s FEHBlog post.
  • Federal News Network adds,
    • “Starting in January 2026, many federal retirees will see a 2.8% cost-of-living adjustment (COLA) increase in their Social Security benefits and federal retirement annuities.
    • “That’s a higher rate than last year, and higher than projections set by AARP and the Senior Citizens League. About 75 million people, including retirees and individuals with disabilities, receive Social Security benefits.
    • “The annual COLA is meant to keep federal retirees’ and Social Security recipients’ benefits on pace with rising inflation. But not everyone will receive the full adjustment.
    • “Retirees in the Federal Employees Retirement System (FERS) usually receive a smaller cost-of-living adjustment each year for their annuities, based on the following formula:
      • “COLA is over 3%: FERS annuitants receive 1% less than the full COLA
      • “COLA is between 2% and 3%: FERS annuitants receive a 2% COLA
      • “COLA is less than 2%: FERS annuitants receive the full COLA
    • “According to those parameters, FERS retirees will receive a “diet” 2026 COLA of 2% for their retirement benefits, starting in January.”
  • FedWeek gives federal and postal employees and annuitants advice on how to approach the upcoming open season.

From the Food and Drug Administration front,

  • Fierce Pharma informs us,
    • “Following a slight delay earlier this year—and a world-first green light in the U.K. over the summer—Bayer has clinched an FDA nod to bolster the limited arsenal of nonhormonal treatments for some of the most common symptoms of menopause.
    • “Friday, the FDA approved Bayer’s dual neurokinin (NK) targeted therapy elinzanetant, which will now be marketed in the U.S. under the brand name Lynkuet, to treat moderate to severe vasomotor symptoms—comprising hot flashes and night sweats—in people with menopause.
    • “Lynkuet comes in a soft gel capsule and is taken once a day at bedtime, Bayer noted in an Oct. 24 press release. The drug is designed to target both the NK1 and NK3 receptors in the brain, which play a role in temperature regulation, the German drugmaker explained.”
    • “Bayer plans to launch Lynkuet in the U.S. starting next month.”
  • and
    • “Azurity Pharmaceuticals has scored an FDA approval for its blood pressure medicine Javadin. The oral solution was developed for patients who have difficulty swallowing tablets or capsules.
    • “Javadin becomes the first immediate-release, ready-to-use oral clonidine formulation for the treatment of hypertension. The berry-flavored treatment can eliminate the need for tablet cutting, compounding or the use of transdermal delivery products to lower blood pressure.
    • “According to the Massachusetts-based company, a recent study showed that more than a third of primary care patients have difficulty swallowing oral medications, with many resorting to splitting or crushing their tablets or opening their capsules to ingest them.”

From the public health and medical / Rx research front,

  • The American Hospital Association News informs us,
    • “Getting an annual flu vaccination is the best way to prevent flu and its potentially serious complications. 
    • “The Centers for Disease Control and Prevention recommends that anyone 6 months of age and older get vaccinated, particularly people who are at a high risk for flu complications. This includes people 65 years and older, young children, and people with chronic conditions such as asthma or heart disease. Individuals who care for or live with these high-risk populations also should get vaccinated.
    • “The 2024-2025 flu season was intense, with high levels of activity and hospitalizations across the country. Somewhere between 47-82 million people fell ill, causing an estimated 27,000-30,000 deaths. The flu vaccine is updated for the 2025-2026 season and is now available at many workplaces, hospitals, clinics, pharmacies and other locations.
    • “Making the case for the value of flu vaccination is easy, but individuals and communities must be proactive in committing to receive them. For 10 years, the AHA has been pleased to lead United Against the Flu, a collaborative effort by several national health care organizations to amplify the importance of getting the annual vaccine.”
  • BioPharma Dive adds,
    • “Sanofi on Friday reported a sharp decline in quarterly vaccine sales, a development the French company partially tied to lower immunization rates in the U.S.
    • “In its latest earnings report, Sanofi said that its overall vaccine sales fell by 7.8% to €3.4 billion, or $3.9 billion, between July and September. The pullback was largely driven by a slowdown in influenza shots, which, combined with the revenue Sanofi derives from Novavax’s COVID-19 vaccine Nuvaxovid, decreased by 16.8%, to €1.5 billion. Sanofi’s COVID-19 and influenza vaccine sales are down a total of 14% this year, the company said.” * * *
    • “It’s early. We’re still in October. But I think it’s fair that with the first few weeks that we observed a little bit of vaccination rate on the soft side when it comes to flu vaccination, particularly in the U.S.,” Thomas Triomphe, Sanofi’s head of vaccines R&D, told analysts.”
    • [Absent the shutdown, we would have had CDC info on this topic.] 
  • The University of Minnesota’s CIDRAP relates,
    • “New research suggests that nearly 1 in 5 urinary tract infections (UTIs) in Southern California may be caused by strains of Escherichia coli that originated in food-producing animals.
    • “For the study, a team led by scientists at George Washington University and Kaiser Permanente Southern California (KPSC) conducted molecular analysis of more than 5,700 extraintestinal pathogenic E coli (ExPEC) isolates collected from UTI patients and retail meat samples from stores in the neighborhoods where those patients lived. Using comparative genomic analysis and a model they developed to infer the host origin of each isolate, they found that 18% of the UTIs were linked to ExPEC strains that came from the meat.
    • “They also discovered that UTIs in patients from high-poverty neighborhoods were 60% more likely to be caused by these zoonotic (animal-to-human) ExPEC strains. 
    • “The findings were published yesterday in the journal mBio.
    • “These findings underscore the contribution of zoonotic ExPEC to the UTI burden in Southern California and the need for targeted interventions to reduce risk in vulnerable communities,” the study authors wrote.”
  • Per STAT News,
    • “Telehealth companies that have seized on the boom in weight loss drugs are playing a bigger role not just in treating patients with obesity but also shaping how the medical mainstream understands obesity.
    • “A dominant player in the field, Ro, said Friday it has launched a new questionnaire designed to measure “food noise,” a term that people with obesity often use to describe incessant and debilitating thoughts about food. One of the aims of the scale, which was developed by academic researchers with funding from Ro, is to help assess whether treatments can “quiet” patients’ level of food noise, a concept that has become more popular in recent years with the advent of new GLP-1 drugs Wegovy and Zepbound.
    • “The telehealth firm is already using the scale to track patients’ progress as they go through treatment, and it’s also licensing it out to pharma companies to use in clinical trials.
    • “WeightWatchers, which also provides telehealth care, earlier rolled out its own food noise scale.
    • “Proponents of these scales say that food noise anecdotally appears to be a common experience for people with obesity, so it’s important to measure it in an objective way to understand a range of questions — for instance, whether certain populations experience it more, how much of it is tied to a person’s weight, and ultimately, which interventions can help.”
  • Per Healio,
    • “Decreasing alcohol intake, even if an individual reports having two or fewer drinks per day, may have a positive impact on blood pressure, researchers reported.
    • “New data published in the Journal of the American College of Cardiology showed how small reductions in alcohol intake can lower BP for both men and women. 
    • “The implications are quite direct. For individuals with hypertension — as well as for the general adult population — stopping alcohol intake can be viewed as a practical, non-pharmacological strategy associated with lower BP,” Takahiro Suzuki, MD, MPH, clinical fellow at St. Luke’s International Hospital and PhD student at the Institute of Science Tokyo, told Healio. “Importantly, this recommendation should not be limited to heavy drinkers. Our findings demonstrate that even light to moderate drinkers can gain measurable benefit from stopping alcohol. A reduction of just 2 mm Hg in systolic BP can meaningfully decrease the risk of stroke and CV death at the population level. Thus, encouraging minimal alcohol intake for everyone could have significant population-level health benefits. … These results align with and support the 2025 American College of Cardiology/American Heart Association guidelines that include recommendations for alcohol abstinence or limiting intake.”
  • Per MedPage Today,
    • “A risk model showed promise for risk-stratifying women for breast cancer treatment-related heart failure or cardiomyopathy.
    • “The model achieved an overall accuracy of about 80% over 10 years.
    • “Older age, specific systemic therapies, and pre-existing cardiac risk factors contributed the most to the model.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nashville, Tenn.-based HCA Healthcare reported a net income of $1.6 billion (8.6% margin) in the third quarter, a significant improvement on the $1.3 billion net income (7.3% margin) posted in the third quarter of 2024. HCA said the strong financial results were driven by higher revenue, improved earnings and growth in same-facility admissions.
    • “For the nine months ending Sept. 30, 2025, HCA reported a net income of $4.9 billion (8.7% margin) compared to $4.3 billion (8.3% margin) in the prior-year period. 
    • “Our teams continued to execute our agenda at a high level, and we remain disciplined in our efforts to improve care for our patients by increasing access, investing in advanced technology, and training our people,” CEO Sam Hazen said in an Oct. 24 earnings release. “Across many operational measures, including quality and key stakeholders’ satisfaction, outcomes were better.”
  • and
    • “More hospitals have closed in Pennsylvania than in any other state this year, reflecting a growing crisis in the state’s healthcare infrastructure. 
    • “Of the 22 hospital closures Becker’s has reported on in 2025, four were in Pennsylvania. One additional hospital — Sharon (Pa.) Regional Medical Center — closed in 2024 but was acquired and reopened in May by Tenor Health Foundation, a newly formed nonprofit.
    • “Pennsylvania’s hospital challenges are multifaceted, involving a combination of overextended acquisition strategies, reimbursement shortfalls, workforce shortages and a rising tide of high-severity malpractice settlements.
    • “According to Radha Savitala, co-founder and CEO of Tenor Health Foundation, part of the issue stems from Pennsylvania’s high number of hospitals — many of them rural — and the fact that some health systems likely overpaid for certain acquisitions in the state more than a decade ago.”
  • MedCity News interviews interviews Puneet Maheshwari, UHC senior vice president and general manager of Optum Real, about the new AI driven claims processing system.
  • Beckers Payer Issues adds,
    • “Elevance Health is deepening its use of artificial intelligence enterprise-wide, focusing on enhancements to its member services, clinical workflows and provider operations as part of long-term efforts to simplify care delivery and reduce costs.
    • “Chief Digital Information Officer Ratnakar Lavu told Becker’s the company’s goal is “to keep the patient at the center and a focus on the experience, not technology for the sake of technology.”
    • “Elevance’s strategy is among a broader industry shift among large insurers using AI not just for automation, but for personalization and decision support that spans both administrative and clinical processes.”
  • BioPharma Dive relates,
    • “Adverum Biotechnologies, a gene therapy developer, has agreed to sell all its outstanding shares to Eli Lilly for an upfront amount that is less than the company’s most recent closing stock price.
    • “Lilly, through an acquisition announced Friday, plans to pay $3.56 in cash for each share — reflecting a nearly 15% discount from the $4.18 price they traded at the day prior. Yet, Adverum investors would also receive so-called contingent value rights that may be worth up to $8.91 per share if the company’s most advanced therapy hits certain goals.
    • “Altogether, the deal value could reach roughly $261 million.
    • “Adverum, formerly named Avalanche Biotechnologies, has been working for nearly two decades to develop genetic medicines for sight-threatening eye diseases. The company raised $102 million in 2014 by going public, and changed its name not long after as part of a reverse merger. Its lead research program is evaluating whether a gene therapy known as “ixo-vec” can help patients with the “wet” form of a degenerative eye condition that affects millions of people in the U.S. alone.”

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Bloomberg Law reports,
    • “Political pressure points set to hit around Nov. 1 could force lawmakers to negotiate an end to the government shutdown.
    • “Funding shortfalls and other deadlines for health care, military pay, and nutrition benefits will collide on or around the first of next month, potentially creating new bipartisan urgency for lawmakers to end the shutdown set to enter its fourth week on Wednesday.” 
  • The American Hospital Association News tells us,
    • The AHA provided a statement for a Senate Special Committee on Aging hearing today on shoppable services that improve health outcomes and lower costs. The AHA asked Congress to take certain steps to address hospital price transparency requirements, including streamlining existing policies that prioritize reducing potential patient confusion and unnecessary regulatory burden on providers; ensuring pre-service estimates are as accurate as possible; continuing to seek input from patients, providers and payers on ways to make more patient-centered federal price transparency policies; and refraining from advancing additional legislation or regulations that could further confuse or complicate providers’ ability to provide meaningful price estimates and add unnecessary costs. In addition, the AHA urged Congress to reject any efforts to expand site-neutral payment cuts.”
  • Per a Senate news release,
    • “On Wednesday, October 29, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on how we can better deliver lifesaving cures to patients and maintain American dominance in medical innovation.”
  • Modern Healthcare informs us,
    • “The Trump administration chose a new leader for a federal health research funding organization that focuses on high-risk, high-reward programs, after firing its previous head in February.
    • “Alicia Jackson, a health technology entrepreneur who used to work for the Defense Department, was appointed director of the Advanced Research Projects Agency for Health, according to the Department of Health and Human Services, confirming an earlier Bloomberg News report.
    • “The agency known as ARPA-H is part of HHS and one of several U.S. government research accelerators that support cutting-edge projects unlikely to attract traditional funding or commercial investment. It has programs in precision cancer therapy, manufacturing personalized genetic medicines, fixing brain damage and enabling joints to heal themselves, according to its website.”
  • The Paragon Health Institute released a paper suggesting ways to improve the CMS Innovation Center.
    • “The CMS Innovation Center has largely failed to produce models with savings or quality improvements. Despite savings projections in the tens of billions, the center’s models have generated more than $5 billion in costs in its first decade.
    • “The voluntary nature of demonstrations, flawed benchmarks, and an inadequate focus on savings have produced poor results.
    • “The Innovation Center’s new strategy seeks to rectify past issues with a renewed focus on evidence-based prevention, patient empowerment, choice and competition, and savings.
    • “Congress and CMS can reform the Innovation Center by prioritizing limited and true demonstrations that are primarily mandatory and based in markets with a focus on definitive savings.
    • “If these reforms are not adopted or are not successful, the Innovation Center should be terminated.”

From the Food and Drug Administration front,

  • Beckers Hospital Review points out,
    • “The FDA is requiring updated labeling for tranexamic acid injection to emphasize the risk of serious harm, including death, if administered incorrectly via spinal injection.
    • “Tranexamic acid injection is indicated for short-term use — two to eight days — in patients with hemophilia to reduce or prevent hemorrhage during and after tooth extraction. It is supplied in single-dose ampules and vials containing 1,000 milligrams in 10 milliliters, and in sodium chloride injection bags with 1,000 milligrams in 100 milliliters.
    • “The agency is mandating a boxed warning, a contraindication for neuraxial (spinal and epidural) use, and revised dosage instructions specifying that the drug must be administered intravenously, according to an Oct. 21 news release. The FDA took action after reviewing cases in which tranexamic acid was mistakenly administered intrathecally or epidurally instead of local anesthetics such as bupivacaine or lidocaine. These errors resulted in prolonged hospitalizations and deaths.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reportshttps://www.cidrap.umn.edu/measles/us-measles-cases-top-1600-south-carolina-outbreak-grows,
    • “The Centers for Disease Control and Prevention (CDC) said today the country has seen 1,618 confirmed measles cases so far in 2025, 22 more than last week. And in South Carolina, a measles outbreak linked to two schools with low student vaccination rates has grown by 4 cases. 
    • “The total represents the most US infections since 1992, when the CDC reported 2,237 measles cases.
  • The New York Times adds
    • Just as one large measles outbreak peters out in the United States, another outbreak of the virus has taken off along the border of Utah and Arizona.
    • The new outbreak began in August and has sickened more than 100 people, making it the second-largest cluster of cases in the country this year. A majority of the cases are in unvaccinated people. * * *
    • “There are several parallels between the current situation at the Utah-Arizona border and the outbreak that exploded from the Western edge of Texas in January: Both started in rural towns with a sizable population of children who had not been immunized against measles, mumps and rubella. And in both outbreaks, the virus traveled to a neighboring state and took root in similarly vulnerable pockets.” * * *
    • “In the current outbreak, cases have been clustered in Colorado City, Ariz., and Hildale, Utah — adjoining cities with historical ties to the Fundamentalist Church of Jesus Christ of Latter-day Saints, a polygamist offshoot of the Mormon Church. However, local public health officials said the virus had spread beyond members of that religious group into the broader community, where vaccination rates have dropped steeply since the pandemic.
    • “In Mohave County, Ariz. — which now has the second-highest case count of 2025, only after the Texas county at the center of the Southwest outbreak — roughly 90 percent of kindergartners were fully vaccinated against measles in the 2019-20 school year.
    • “But by the 2024-25 school year, the vaccination rate had dropped to 78 percent. (About 95 percent of a community needs to be vaccinated to stem the spread of measles, which is one of the most contagious known viruses.)
    • “Data from Southwest Utah tell a similar story: Vaccination rates dropped nearly eight percentage points over the course of the pandemic to about 78 percent.”
  • The New York Times also relates,
    • “Bird flu is back. After a quiet summer, the virus has hit dozens of poultry flocks, resulting in the deaths of nearly seven million farmed birds in the United States since the beginning of September. Among them: about 1.3 million turkeys, putting pressure on the nation’s turkey supply in the run-up to Thanksgiving.
    • “Reports of infected wild birds have also surged this fall, and three states — Idaho, Nebraska and Texas — have identified outbreaks in dairy cows.
    • “The virus often flares up in the fall as wild birds begin migrating south; this year, the uptick is occurring during a government shutdown, as federal agencies that are typically involved in the response are working with skeletal staff.”
  • Per MedPage Today,
    • “A large study suggested that older women who took at least 4,000 steps 1-2 days per week had lower risks of death and heart disease.
    • “Participants who reached that threshold 3 or more days per week had a 40% lower mortality risk.
    • “Researchers said the key factor was the total number of steps per day — not how many days per week a certain number was reached.”
  • and
    • “With new research shedding light on how our food affects respiratory function and the progression of disease, interest in the role of diet in lung health is increasing. The reasoning behind it is based on the possible anti-inflammatory qualities of some diets and the fact that some lung conditions, such as asthma and chronic obstructive pulmonary disease (COPD), are inflammatory diseases, Maria Sfika, MD, pulmonary resident at Attikon University Hospital in Athens, Greece, told Medscape Medical News.
    • “However, at the European Respiratory Society (ERS) 2025 International Congress, in Amsterdam, researchers presented a nuanced picture. While a healthy diet generally supports better lung function and can improve control of certain conditions, its benefits may be mediated through weight control.”
  • and
    • “Glovadalen (UCB), an investigational brain-penetrant D1 receptor positive allosteric modulator (D1 PAM), is both safe and effective for patients with advanced Parkinson’s disease (PD), new research showed.
    • “Results from the phase 2 ATLANTIS trial, which included more than 200 patients with PD and significant daily motor fluctuations, showed that those who received oral glovadalen plus standard care for 10 weeks had a greater reduction in number of OFF hours per day than those who received matching placebo, meeting the primary endpoint.
    • “Additionally, significantly more participants receiving active treatment reported feeling better on the Patient Global Impression of Change (PGI-C) of PD symptoms scale than those receiving placebo.”
  • Per Genetic Engineering and Biotechnology News,
    • “By the time patients start seeking care for multiple sclerosis (MS), the disease has already been damaging their brain for years. But until recently, scientists didn’t understand which brain cells were being targeted or when the injury began.
    • ‘Now, by analyzing thousands of proteins found in the blood, scientists at the University of California, San Francisco (UCSF), have created what they view as the clearest picture yet of when the disease attacks the myelin sheath that covers the nerve fibers. It shows that the immune system begins attacking the brain even earlier than previously had been thought.
    • “The study “Myelin injury precedes axonal injury and symptomatic onset in multiple sclerosis,” published in Nature Medicine, measured debris from these attacks in a person’s blood, along with the signals that coordinate the immune system to go on the attack. It lays out, for the first time, the sequence of events that eventually lead to the disease.
    • “The discovery could lead to new ways to diagnose multiple sclerosis—and possibly one day prevent it, noted the scientists.” 
  • The New York Times reports,
    • “A new large-scale analysis found that the short-term cardiovascular and metabolic side effects of antidepressants vary widely by drug, but the ones most commonly prescribed in the United States are linked to relatively mild issues.
    • “Tens of millions of U.S. adults take antidepressants for mental health conditions such as depression and anxiety. Like any medication, antidepressants have well-established side effects for some people. Researchers at institutions including King’s College London and the University of Oxford wanted to better understand just how much those side effects differed from drug to drug.
    • “The new study, published Tuesday in The Lancet, is among the largest meta-analyses to compare some of the short-term side effects of antidepressants. The findings may help millions of doctors work with their patients to determine the right choice for them in a sea of options.”
  • Per STAT News,
    • “Moderna said Wednesday afternoon that its experimental vaccine for cytomegalovirus, a cause of disability in newborns, failed in a Phase 3 trial, a significant setback for a company already facing pressure from Wall Street and the federal government.
    • “The CMV vaccine had been the company’s lead program prior to the Covid-19 pandemic. Leadership had repeatedly said it could bring in between $2 billion and $5 billion in peak annual sales. Analysts polled by Visible Alpha forecast peak sales of $1.6 billion for the product.

From the HLTH 2025 Conference

  • Healthcare Dive reports,
    • “A top aide for HHS Secretary Robert F. Kennedy, Jr. made waves at the HLTH conference when he accused players across the healthcare industry of capitalizing off of chronic illnesses and turning a blind eye to potential root causes of the conditions, like diet.
    • “The problem is that most people in this room are just predominantly making money off more sick patients. And that’s just an economic fact,” Calley Means, an influential advisor to Kennedy, said.
    • “Means spoke on a panel Tuesday about the Make America Healthy Again movement, which centers around reducing chronic disease by reforming food, health and science systems. A groundswell of public support for MAHA helped usher President Donald Trump into office, and the president created a MAHA Commission through an executive order in February.”
  • and
    • “American Nurse Association President Jennifer Mensik Kennedy says industry pressures are coalescing to worsen nursing shortages.
    • “Studies estimate the U.S. will need 1.2 million new registered nurses by 2030 to meet care demands. The ANA, American Hospital Association and health systems have doggedly called for solutions to the growing labor crisis for years, with some health systems opting to acquire their own nursing schools to ensure sufficient pipelines of talent.
    • “Still, Kennedy says barriers remain to educating, recruiting and retaining quality nurses. Some problems are old hat — for example, it’s difficult to entice nurses to take a pay cut to become a nurse educator. However, new challenges are of the cultural and political moment, according to Kennedy, including developing strategies to retain nurses burnt out by patients peddling misinformation.”
    • The article also features a Healthcare Dive interview with the ANA President.
  • and
    • “The window for digital health initial public offerings has opened after a long period of stagnation, but the outlook isn’t entirely smooth for firms looking to make the leap to the public markets, experts said at the HLTH conference this week.
    • “Few digital health companies have entered the public markets in recent years, in sharp contrast to a surge of health technology IPOs in 2021. However, many firms that went public during the pandemic-era funding boom struggled in the spotlight — and some collapsed altogether. 
    • “There’s plenty of uncertainty in healthcare right now, making it more challenging for companies to decide to make a move, Robbert Vorhoff, managing director and global head of healthcare at private equity firm General Atlantic, said during a panel discussion at HLTH.”
  • Modern Healthcare adds,
    • “Virta Health Chief Commercial Officer Laura Walmsley said in a panel on Monday at HLTH that some employers are looking for GLP-1 alternatives that can be as effective as weight loss drugs. She said Virta Health, a virtual diabetes care company, has sold nutrition-only therapy solutions to employers looking to forgo covering GLP-1s for weight loss.
    • “Most employers are not covering GLP-1s for weight loss,” Walmsley said. “Greater than 50% are not covering them.”
  • and
    • “Cleveland Clinic is using AI to identify patients who may need surgery. The health system hopes to reduce costs and limit care complications by treating patients before conditions worsen.
    • “Predictive modeling can sift through claims data to flag a patient who may need spinal surgery, a heart procedure, bariatric surgery or other treatment. The technology has increased referrals to Cleveland Clinic and bolstered partnerships with employers and insurers, said Meghan Cassidy, senior director of sales and product development at Cleveland Clinic, in an interview at HLTH on Tuesday.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The cost of health insurance rose steeply for a third year in a row in 2025, reaching just under $27,000 for a family plan, according to an annual survey from the nonprofit KFF, which provides the broadest picture of U.S. employer health coverage. 
    • “That is a 6% increase from the year before and builds on two prior years of 7% gains. The cost is rising faster than inflation, and economists and business leaders said it could bite into employment and wage growth. 
    • “If healthcare costs go up faster than the economy in general, that means there’s less money left over to go to wages,” said Gary Claxton, a senior vice president at KFF. 
    • “J.H. Berra Paving Co., in St. Louis, is struggling with this trade-off. The company is facing a 15% health-insurance rate increase this year, on top of last year’s increase, said John O’Connor, a risk manager for the company. That extra cost is likely to put a lid on wage increases for the company’s workers, O’Connor said.
    • “The KFF survey, which includes more than 1,860 employers and was completed earlier this year, offers a detailed snapshot of workplace insurance. Nearly half the U.S. population gets health coverage through a job.”
  • Modern Healthcare relates,
    • “MultiCare Health System and Samaritan Health Services look to combine the two nonprofit health systems, they announced Wednesday.
    • “The boards of the organizations approved a membership-substitution agreement that would make Tacoma, Washington-based MultiCare the parent company of Corvallis, Oregon-based Samaritan. MultiCare operates 13 hospitals and more than 300 primary, urgent, pediatric and specialty care facilities, while Samaritan operates five hospitals, more than 80 clinics and multiple health plans. 
    • ‘The systems plan to sign a definitive agreement in the coming weeks and close the proposed deal in mid-2026, pending customary regulatory approvals, according to a news release. A MultiCare spokesperson said the organizations in July signed a nonbinding letter of intent but did not disclose financial details.”
  • Per STAT News,
    • “As pharma companies and President Trump tout initiatives to sell branded medications directly to cash-paying consumers, some entrepreneurs have seized on a potential business opportunity — pitching a new model for employers to help their workers pay for medications without using insurance. 
    • “Take the blockbuster obesity treatments Wegovy and Zepbound, for example. Many employers don’t cover them, since they find them too expensive to add to their health plans. But now that the drug manufacturers Eli Lilly and Novo Nordisk have started selling the products directly to patients at about $500 a month, employers are being incentivized by startups to subsidize part of the cash price for their workers.
    • “Their pitch is this: Employers can pay less than they would if they covered the drugs through insurance and, with a subsidy, employees can get the treatments at a lower cost than if they paid the full cash price on their own. 
    • “One company, RxSaveCard, is charging employers a set fee to help them set up this model. CEO Chris Crawford said in an interview that the company has seen interest take off as more pharma companies launch direct-to-consumer sales and that hundreds of employers have either already signed up for RxSaveCard or will be adopting the model next year.
    • “Another new company, Andel, announced this week that it will launch a platform that will adopt a similar model for GLP-1 treatments and eventually for other branded drugs as well.”
  • Per Reuters,
    • Walmart (WMT.N) will become the first U.S. retailer to sell Abbott Laboratories’ (ABT.N), over-the-counter continuous glucose monitor Lingo in physical stores, an Abbott spokesperson said on Tuesday.
    • Abbott’s device, which was previously available only at HelloLingo.com and Amazon, will now be sold in Walmart’s 3,500 stores across the U.S.
    • Continuous glucose monitor makers such as Abbott, Dexcom (DXCM.O) and Medtronic (MDT.N) are riding a surge in demand as diabetes awareness rises, insurance coverage expands and patients embrace finger-prick-free technology.
  • Per BioPharma Dive,
    • “Brain drug developer Alkermes could spend billions of dollars in a new deal that, if completed, would give the company a marketed medication to build out its burgeoning sleep business.
    • “Alkermes on Wednesday said it has agreed to purchase Ireland-based Avadel Pharmaceuticals for $18.50 per share, reflecting a 3.5% premium to the latter company’s closing share price the day prior. Avadel’s main asset, Lumryz, is similar to the sleep drug Xyrem, which at its peak generated close to $2 billion in annual sales. Lumryz is already approved to treat excessive daytime sleepiness or cataplexy, a symptom of one form of narcolepsy that’s characterized by a sudden loss of muscle strength.”
  • and
    • Takeda [a Japanese pharmaceutical manufacturer] is turning to China to fuel its oncology pipeline, announcing Wednesday a wide-ranging collaboration with Innovent Biologics that could be worth more than $11 billion.
    • Through the alliance, Takeda is gaining rights outside of Greater China to two experimental cancer therapies in late-stage testing. It also acquired an option to a third in earlier development. Innovent, which is based in Suzhou, China, will receive $1.2 billion up front as well as a $100 million equity investment at a 20% premium to its current trading price on the Stock Exchange of Hong Kong. 
    • Takeda could add another $10.2 billion to the deal, if all three molecules hit a variety of development milestones.
  • Per MedTech Dive,
    • “The number of procedures performed with Intuitive Surgical’s flagship da Vinci system picked up pace in the third quarter, lifting the robot maker’s sales and earnings above Wall Street forecasts.
    • “Total procedures increased year over year by 20% worldwide, compared to 17% in the second quarter, which was the rate for all of 2024. Meanwhile, revenue rose 23% year over year to $2.51 billion, surpassing the average analyst forecast by $10 million, according to Citi Research.
    • “Procedure demand has been healthy,” Intuitive CEO Dave Rosa said on Tuesday’s earnings call.”

Friday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, HSA, Medical / Rx research, No Surprises Act, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

  • The American Hospital News lets us know,
    • “The Senate Oct. 16 failed for a 10th time to advance the continuing resolution to extend government funding and end the ongoing shutdown. The chamber adjourned until Oct. 20, pushing the shutdown into next week. The House continues to remain out of session with no plans to return. Lawmakers remain at an impasse, and no formal negotiations have resumed.”
  • Govexec informs us,
    • “President Trump on Wednesday signed a new executive order effectively indefinitely extending the ongoing hiring freeze, albeit while creating new requirements for federal agencies to obtain exceptions as well as new opportunities to politicize the federal workforce.
    • “Trump’s hiring freeze, first implemented on Jan. 20, was set to expire Wednesday. The new order, entitled Ensuring Continued Accountability in Federal Hiring, requires agencies to create a strategic hiring committee, whose membership should include the deputy agency head and the agency head’s chief of staff, to approve “the creation or filling” of each vacancy within the organization. It also requires the creation and submission to both the Office of Personnel Management and the Office of Management and Budget of an annual staffing plan.
    • “In these plans, agencies shall seek to improve operational efficiency; eliminate duplicative or unnecessary functions and positions; reduce unnecessary or low-value contractor positions; promote employee accountability; enhance delivery of essential service; appropriately prioritize hiring for national security, homeland security and public safety positions; and implement the recruitment initiatives described in the merit hiring plan,” the order states. “Going forward, agencies shall prepare, in coordination with OPM and OMB, annual staffing plans to implement at the start of each new fiscal year.”
  • OPM Director Scott Kupor discusses the new executive order in this week’s post in his Secrets of OPM blog.
    • “The goal of this exercise is not for OPM nor OMB to question the judgment of our very capable agency heads; without a doubt, the “CEOs” of these organizations know their agencies far better than do we. Rather, the goal is to provide a level of pan-government visibility across resourcing in furtherance of the key initiatives that the president has laid out. And, in doing so, we can look for ways to maximize efficiency and deliver the best possible set of services to the American people.
    • “For example, if we learn that collectively across agencies we are looking to hire 10,000 engineers this year, then OPM can help design an x-government process to facilitate more centralized hiring. Or, if we see that there are core personnel resources that are being duplicated across agencies that could be more effectively done via specialization and centralization, OPM can help drive that as well. And this list goes on.
    • “None of this is rocket science. But President Trump rightfully recognizes that the federal government needs to operate on the same fundamental practices that do all modern organizations writ large.
    • “Rationality prevails – at least for now – in DC.”   
  • 401k Specialist points out,
    • “Assets in health savings accounts (HSAs) climbed to $146 billion in 2024, with an 18% year-over-year increase, according to new data out today from Morningstar.
    • “The investment analyst’s latest Health Savings Account Landscape Report notes that the tax benefits associated with HSAs, along with widespread adoption of high-deductible health plans (HDHPs), has accelerated growth among the savings vehicles.
    • “Growing adoption of HDHPs has coincided with HSA asset growth, Morningstar reports. According to the findings, the percentage of workers in employer-sponsored medical insurance plans that have elected HDHPs increased from 7% in 2006 to 32% by the end of 2024. In that same timeframe, HSA assets rose to $146 billion from close to $5 billion about 20 years ago.
    • “In nearly a decade of research, we’ve seen the HSA industry mature considerably as more individuals take advantage of the powerful tax advantages and long-term savings potential these accounts offer,” said Greg Carlson, senior manager research analyst at Morningstar, in a statement.”
  • Fierce Healthcare relates,
    • “A new evidence-based framework aims to establish a U.S. industry standard for measuring health equity efforts.
    • “Put out by the Institute for Healthcare Improvement (IHI), the white paper has been in the works for two years. It offers a four-step approach to help healthcare teams across settings identify health disparities. Advancing health equity is defined in the paper as reducing and eliminating health disparities that adversely affect historically underserved groups.
    • “We’re hoping that this will be a standardized approach to data and measurement,” Nikki Tennermann, IHI senior project director and an author of the white paper, told Fierce Healthcare. “We wanted to make sure that this framework was accessible to big large integrated health systems but also maybe it’s a small local mental health alliance.”
    • “In healthcare, there is no single standard to identify, quantify, track and report health equity gaps in patients, per the paper. The framework aims to address that. More than 35 subject-matter experts representing clinical, quality, payer, academic and administrative roles contributed to the framework.”  
  • Fierce Pharma notes,
    • “Six years since the FDA blessed Sanofi and Regeneron’s Dupixent as the first biologic to treat chronic rhinosinusitis with nasal polyps (CRSwNP), a second biologic therapy has broken through with a nod in the indication.
    • The U.S. regulator has endorsed Amgen and AstraZeneca’s Tezspire as an add-on maintenance treatment for patients age 12 and older. The first-in-class monoclonal antibody, which is injected monthly, inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine which triggers inflammation.
    • It’s this novel mechanism of action that keys the effectiveness of Tezspire, which has produced clinical results that suggest it could become the top product on the market for CRSwNP.”

From the judicial front,

  • Govexec reports,
    • “The Trump administration on Friday vowed to comply with a judge’s order to halt any layoffs caught up in a court-ordered pause on such reductions, though it left the door open to cuts of personnel not currently party to the lawsuit.” * * *
    • “The plaintiffs on Friday filed an amended complaint seeking to add the National Federation of Federal Employees, the National Association of Government Employees and the Service Employees International Union to the case to ensure protection for those workers as well. In an emergency an emergency hearing for Friday evening, the judge on the case agreed to expand her order to include those employees.”  
  • Beckers Payer Issues relates,
    • “Wellmark Blue Cross and Blue Shield has filed a lawsuit against Iowa’s insurance commissioner, challenging the enforcement of a newly enacted state law that regulates pharmacy benefit managers and the administration of prescription drug benefits.
    • “The lawsuit, filed on Oct. 14 in an Iowa federal court, claims that the legislation violates the First Amendment and the Employee Retirement Income Security Act. The lawsuit stems from the Iowa court’s previous ruling in a case involving the Iowa Association of Business and Industry, which had sought to block the bill, and a ruling in July that partially found the law to be invalid.
    • “While the court granted a preliminary injunction in that case and blocked the law’s enforcement against certain plaintiffs, Wellmark argues that the injunction does not extend to other entities like itself, which were not part of the previous lawsuit. Wellmark claims that the enforcement of the new law would harm its business and members by imposing significant costs and regulatory burdens, especially those tied to provisions the court previously found unconstitutional, including anti-referral and anti-promotion requirements for pharmacies and PBMs.
    • “The complaint also argues that many provisions of the law violate ERISA’s preemption provisions and impose regulations that interfere with the administration of ERISA plans. Wellmark has requested an injunction to block enforcement of the provisions that have been enjoined in the other lawsuit, as well as additional provisions that affect its role in administering ERISA-covered plans.” 
  • The Miller & Chevalier law firm observes,
    • “Air ambulance providers Guardian Flight, LLC, and Med-Trans Corporation, both of whom lost their bids to sue payors in court for payment of No Surprises Act (NSA) Independent Dispute Resolution (IDR) determinations, petitioned the U.S. Supreme Court on October 8, 2025, seeking to overturn a Fifth Circuit decision finding no private right of action under the NSA. Guardian Flight, L.L.C., et al. v Health Care Service Corporation, No. 25-441 (U.S.).” * * *
    • “The majority of federal courts that have addressed the issue of whether the NSA provides a private right of action have decided it does not and the Fifth Circuit is the only federal appellate court to rule on this issue. Without a circuit split, it will be surprising if the Court takes up this issue at this time.” 

From the public health and medical / Rx research front,

  • Per the University of Minnesota’s CIDRAP,
    • “In a precursor to what we might expect in the coming flu season in the United States and across the Northern Hemisphere, a new study shows flu vaccine effectiveness (VE) to be around 50% for both clinic visits and hospital stays for influenza during the 2025 Southern Hemisphere flu season.
    • “The findings, which demonstrate that the vaccine cuts the rate of medical care for flu in half, were published recently in Morbidity and Mortality Weekly Report by researchers with the US Centers for Disease Control and Prevention (CDC), the Pan American Health Organization, and their collaborators in Southern Hemisphere nations.
    • “CDC recommends that all eligible persons aged ≥6 months receive the seasonal influenza vaccine,” the authors note. “The 2025–26 Northern Hemisphere seasonal influenza vaccine composition is the same as that used during the 2025 Southern Hemisphere influenza season and might be similarly effective if the same viruses circulate in the coming season.”
  • Beckers Clinical Leadership tells us,
    • “U.S. adult obesity prevalence has dipped slightly year over year, with fewer states reporting obesity rates at or above 35%. However, the nation continues to face a high overall obesity rate.
    • “That’s according to a new report released Oct. 16 by Trust for America’s Health.
    • “Nineteen states had adult obesity rates at or above 35% last year, down from 23 in 2023, according to “The State of Obesity: 2025,” which is based in part on TFAH’s analysis of 2024 CDC data, and recent data from the 2021-2023 “National Health and Nutrition Examination Survey.”
    • “Still, the analysis found that slightly more than 4 in 10 U.S. adults have obesity, and rates are rising among children and adolescents, with more than 21% of those ages 2 to 19 affected.”
  • Health Day adds,
    • “A new definition of obesity could dramatically increase the number of Americans considered obese.
    • “Under the new definition, the prevalence of obesity rose from around 40% to nearly 70% among more than 300,000 people participating in a long-term health study, researchers reported Oct. 15 in JAMA Network Open.
    • “The new definition takes into account additional measures of excess body fat rather than just relying on body mass index (BMI). BMI is an estimate of body fat based on height and weight.
    • “We already thought we had an obesity epidemic, but this is astounding,” said co-lead researcher Dr. Lindsay Fourman, an endocrinologist at Mass General Brigham in Boston.
    • “With potentially 70% of the adult population now considered to have excess fat, we need to better understand what treatment approaches to prioritize,” she said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “The gut microbiome has been increasingly connected to a myriad of conditions, in part due to the metabolic output of the microbes in the gut. Studies have suggested that exposure to carcinogens or toxins can have a broader impact on health. The brain-gut microbiome connection has also been under investigation. How the gut microbiome impacts the brain’s response to and preference for alcohol has not yet been thoroughly explored.
    • “Researchers at Tufts University have found a connection between a gut fungus, Candida albicans, and the dopamine pathway in the brain. Their paper titled, “Candida albicans colonization modulates murine ethanol consumption and behavioral responses through elevation of serum prostaglandin E2 and impact on the striatal dopamine system,” was published in mBio.” * * *
    • “While many treatments for alcohol use disorder hinge on behavioral modifications, exploration of alternative approaches, including therapies involving the gut microbiome, may be a promising path. “We are excited to learn more about the mechanisms that allow microbes to affect host behavior,” shared [the researchers] Kumamoto and Day with GEN.” 
  • and
    • “Faulty brain circuits seen in Down syndrome may be caused by the lack of a particular molecule essential for the development and function of the nervous system, according to a new study in lab mice. Restoring the molecule, called pleiotrophin, could improve brain function in Down syndrome and other neurological diseases, possibly even in adults, the researchers say.
    • “The scientists conducted their work in mice, rather than in people, so the approach is far from being available as a treatment. But the researchers found that administering pleiotrophin improved brain function in adult mice long after the brain was fully formed. That suggests that the approach could offer major advantages over prior attempts to enhance Down syndrome brain circuits that would have required intervention at extremely precise, and brief, times during pregnancy.
    • “This study is exciting because it serves as proof-of-concept that we can target astrocytes, a cell type in the brain specialized for secreting synapse-modulating molecules, to rewire the brain circuity at adult ages,” said researcher Ashley N. Brandebura, PhD, who was part of the research team while at the Salk Institute for Biological Studies and is now part of the University of Virginia School of Medicine. “This is still far off from use in humans, but it gives us hope that secreted molecules can be delivered with effective gene therapies or potentially protein infusions to improve quality of life in Down syndrome.”
  • The Wall Street Journal reports on human longevity research focused on people living beyond 110 years.
    • “Supercentenarians, a rare group of people older than 110, are tracked and their ages validated by an international nonprofit known as the Gerontology Research Group. Two hundred or so are alive today, the eldest now being a 116-year-old British woman.”
  • Per Radiology Business,
    • “One New York organization recently detailed how it was able to more than double the number of eligible patients who complete lung cancer screenings. 
    • “Over a decade after the U.S. Preventive Services Task Force (USPSTF) recommended lung cancer screening (LCS) in high-risk individuals via low-dose CT scans, utilization of the exam has continued to lag. Less than 20% of eligible patients in the U.S. adhere to LCS recommendations, despite numerous studies highlighting the exam’s ability to spot cancer at its earliest stages. 
    • “A group of providers from the University of Rochester Medical Center (URMC) were able to overcome this statistic, increasing their organization’s LCS rates from 33% in 2022 to 72% in 2025, sharing their findings in the New England Journal of Medicine Catalyst.   
    • “Our biggest success was not only screening a high percentage of eligible patients, but also enrolling those patients in the comprehensive program to ensure they receive the necessary annual follow-up screenings,” noted lead author Robert Fortuna, MD, MPH, professor of primary care and pediatrics at URMC.”

From the U.S. healthcare business front,

  • Beckers Clinical Leadership reports,
    • “Productivity, rather than quality, is gaining prominence in physician bonus structures, according to a recent report from recruiting firm AMN Healthcare. 
    • “Last year, 62% of physician contracts featured a production bonus, the report found. That figure has grown to 66%. In comparison, 16% of contracts included a quality metric in its bonus structure, down from 26% in 2024 and 31% in 2023. 
    • “Productivity metrics include relative value units, net collections, gross billings and patient encounters. Quality ranges from patient satisfaction scores to readmission rates, according to the report. 
    • “Despite initiatives “to steer physician payments toward quality metrics and away from volume-based formulas,” according to the report, “finding the right compensation formula … has been elusive.”
    • “Other industry reports have found a similar trend, with base salary and work RVU productivity remaining the most common aspect of physician compensation plans.” 
  • Per Fierce Healthcare,
    • “Amazon One Medical introduced a pay-per-visit telehealth service for common pediatric conditions like pink eye, skin rashes and asthma prescription medication renewals.
    • “The service offers parents and guardians virtual consultations and expert medical advice for select children’s care needs, Amazon executives said in a blog post.
    • “The telehealth service, available for children ages 2 to 11, can help treat pink eye, lice and more than 10 common skin-related issues such as eczema; bug bites; contact dermatitis; impetigo; fungal rashes (e.g., ringworm); hand, foot and mouth disease; fifth disease; roseola; poison ivy; and diaper rash. This service also covers EpiPen and asthma medication renewals. For any prescriptions that are needed, customers can fulfill those orders through Amazon Pharmacy or the pharmacy of their choice. 
    • “Message-based visits start at $29, and video consultations cost $49. Insurance, Prime memberships or Amazon One Medical memberships are not required to use the service.”
  • and
    • “With the launch of its first direct-to-patient (DTP) program, Genentech is joining the wave of drugmakers setting up direct-to-consumer sales of popular products at steep discounts for cash-paying patients.
    • “The Roche subsidiary’s inaugural DTP program will center on Xofluza, its prescription influenza treatment, according to Thursday’s announcement. The single-dose oral antiviral med will be available to eligible uninsured, underinsured and self-pay patients for $50, down about 70% from its list price, per Genentech.
    • “The program will fulfill Xofluza prescriptions via partnerships with a trio of online pharmacies: Alto Pharmacy, Amazon Pharmacy and Mark Cuban Cost Plus Drug Company. Same-day delivery will be available in some U.S. markets through Alto Pharmacy and Amazon Pharmacy.
    • “The new DTC approach to Xofluza sales “will allow us to reach more patients where they are increasingly interested in seeking their medicines,” Genentech CEO Ashley Magargee said in the announcement.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Republicans and Democrats both see a likely path to ending the government shutdown, involving extending enhanced Affordable Care Act healthcare subsidies for a year or longer. But there are a series of reasons why no deal has emerged, even with costs set to surge for more than 20 million Americans.
    • “The shutdown is now entering its third full week, with no serious talks under way. The House passed its short-term bill to fund the government through Nov. 21 and has been out of town since. Democrats have repeatedly blocked the measure in the Senate, where Republicans have a 53-47 majority, but 60 votes are required to advance the legislation.”
  • Per a Senate news release,
    • “Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and John Hickenlooper (D-CO) introduced the 21st Century Dyslexia Act, legislation that incorporates the modern, scientific understanding of dyslexia into federal statute and prevents the harm unidentified dyslexia can inflict on young students.
    • “Despite dyslexia impacting one in five Americans, students are rarely tested,” said Dr. Cassidy. “This legislation brings a common-sense approach to dyslexia, ensuring students have the resources they need to reach their full potential.”
    • “Better early screening, more awareness, and modern tools will help make sure kids with dyslexia are diagnosed early. These resources are inexpensive and immensely valuable. I know – I lived it,” said Senator Hickenlooper.
    • “U.S. Representatives Erin Houchin (R-IN), Julia Brownley (D-CA), and Bruce Westerman (R-IN) introduced the companion legislation in the U.S. House of Representatives.” * * *
    • “Read the full bill text here.”
  • Tammy Flanagan, writing in Govexec, explains “what to know when your child ages out of federal health coverage. Children can stay on a parent’s FEHB or PSHB plan until 26, but understanding the 31-day extension, conversion options and Temporary Continuation of Coverage is key to avoiding gaps.” The FEHBlog’s advice is to move your adult child to their employer sponsored health plan which should be a snap.
  • FedWeek tells us,
    • “An inspector general report has cited some positives for USPS finances but also notes that its financial picture in recent years has benefitted from several special infusions of funding from Congress that it called “unique events.” * * *
    • “First Class mail volume “is not expected to return to levels previously seen in the early part of the 20th century,” it said, and “ultimately, future retirement obligations will need to be funded.”
    • “Eliminating the prefunding requirement temporarily alleviated the Postal Service’s financial burden but did not change the fact that once the [Postal Service Retiree Health Benefits Fund] runs out of funds, the Postal Service is responsible for funding its share of the healthcare premium costs for its retirees as the costs are incurred,” it said.”
  • Per a Labor Department news release,
    • “U.S. Secretary of Labor Lori Chavez-DeRemer today joined President Trump at the White House as the President announced the third most-favored-nation agreement, which will result in significant cost savings on fertility treatments. On the heels of the President’s announcement, the U.S. Department of Labor, joined by the Departments of Health and Human Services and Treasury, issued guidance designed to cut burdensome red tape, helping employers understand how to structure health benefits to expand access to fertility treatments like In Vitro Fertilization or IVF.” * * *
    • “Following the President’s announcement today, the Departments of Labor, Health and Human Services, and Treasury issued new guidance in line with the President’s Executive Order 14216, “Expanding Access to In Vitro Fertilization.” The guidance clarifies existing categories of excepted benefits that employers can use to offer fertility benefits, including fertility treatment through a specified disease or illness policy, or offering reimbursement for those services through an excepted benefits health reimbursement arrangement.
    • “The departments also intend to propose rulemaking aimed at providing additional ways that certain fertility benefits may be offered as a limited excepted benefit. The departments are also considering whether to modify the standards under which supplemental health insurance coverage provided by a group health plan, including a supplemental benefit for fertility coverage, will be considered to satisfy the conditions for being an excepted benefit.”
  • According to a Paragon Health Institute report,
    • “The Inflation Reduction Act caused Medicare Part D stand-alone prescription drug plan premiums to increase nearly 600 percent from 2023 to 2026.
    • “To disguise this premium spike, the Biden administration abused Medicare’s “demonstration” authority. Despite the Biden administration’s $5 billion bailout of the Inflation Reduction Act’s failed policies, the number of plans declined by over half from 2021 to 2025.
    • “The Trump administration has sensibly mitigated this abuse, phased down the bailout, and reduced distortions in the Medicare Part D program.”
  • The Postal Service Health Benefits Program relies heavily on stand-alone Medicare Part D prescription drug plan for benefit cost savings.

From the Food and Drug Administration front,

  • Per an HHS press release,
    • “The U.S. Food and Drug Administration today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing.
    • “Voucher recipients will receive a decision within 1-2 months following filing of a complete application for a drug or biologic. In addition, sponsors will receive enhanced communications with review staff throughout the development process prior to their final submission and during the review period. If necessary, FDA scientists reserve the right to extend the review time if an application is incomplete, there are manufacturing violations, or as they otherwise deem appropriate.” * * *
    • “The following products were selected:
      • “Pergoveris for infertility
      • “Teplizumab for Type I diabetes
      • “Cytisinicline for nicotine vaping addiction
      • “DB-OTO for deafness
      • “Cenegermin-bkbj for blindness
      • “RMC-6236 for pancreatic cancer
      • “Bitopertin for porphyria
      • “Ketamine for domestic manufacturing of a critical drug for general anesthesia
      • “Augmentin XR for domestic manufacturing of a common antibiotic.”
  • Per MedPage Today,
    • “The FDA is warning about the potential for serious injuries with radiofrequency (RF) microneedling for skin procedures following reports of burns, scarring, disfigurement, and nerve damage.
    • “The agency said it is working with manufacturers of the class II medical devices with the hopes of identifying mitigation strategies. “While the FDA’s evaluation is ongoing, we are asking patients, caregivers, and healthcare providers to report any complications to the use of these devices for dermatologic or aesthetic skin procedures.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “The first US case of locally acquired clade 1 mpox has been reported in Long Beach, California, according to city and state health authorities.
    • “The clade 1 case is the nation’s first in a person with no recent travel history and the seventh clade 1 case in the country. The patient required hospitalization and is now isolating and recovering at home, the City of Long Beach news release said.
    • “Public health officials are reviewing the patient’s potential source of exposure and conducting contact tracing. No other cases have been identified.
    • “While the overall risk of mpox clade I exposure to the public remains low, we are taking this very seriously and ensuring our community and health care partners remain vigilant so we can prevent any more cases,” Long Beach Mayor Rex Richardson said in the release. “This underscores the importance of continued surveillance, early response, and vaccination.”
  • The New York Times reports,
    • “A study, published in the journal JAMA Ophthalmology, analyzed the number of eye injuries that brought pickleball players to hospital emergency rooms from 2005 to 2024. Dr. Tsui and his colleagues extrapolated from a database of injuries that relies on a nationally representative sample of hospitals.” * * *
    • “While there were just over 3,100 pickleball-related eye injuries that brought players to emergency rooms between 2014 and 2024, over one-third of them — some 1,262 injuries — occurred in 2024 alone.
    • “Players 50 and older, who were more likely to sustain ocular injuries than younger players, accounted for 70 percent of all eye injuries. Age-related decreases in muscle mass, bone density and balance may have made them more vulnerable, the authors said.” * * *
    • “Eye protection is not required for professional or casual play, the authors of the study noted. USA Pickleball, the sport’s governing body in the United States, last year disapproved of a rule change that would require players to wear eye protection in its tournaments, saying it would be difficult to enforce.
    • “Pickleball clubs and courts also do not require eye protection. But the American Academy of Ophthalmology last year recommended players wear eyewear that meets the American Society for Testing and Materials F3164 guidelines, which are the standard for most racket sports.”
  • United Healthcare, writing in LinkedIn, ponders whether GLP-1 drugs are real-life wonder drugs.
    • “GLP-1 drug sales are up 500% since 2018, with growth accelerating as new uses emerge.
    • “Beyond diabetes and obesity, they show promise for Alzheimer’s, cancer and more.
    • ‘GLP-1 users also saw a 44% drop in hospitalizations from stroke, heart attack and heart failure.”
  • The Genetic Engineering and Biotechnology News relates,
    • “Although it well known that the human gut contains a large and diverse array of bacteriophages, a functional understanding of the phage–host interactions is limited. This is, in part, due to a lack of cultured isolates available. Now, a new study uncovers hundreds of new phages within our gut, information that could eventually reshape the gut microbiome, potentially influencing gut health and the progression of various disease states.
    • “Published in Nature in the paper, “Isolation, engineering and ecology of temperate phages from the human gut,” the study is the first of its kind and uses a large-scale, culture-based approach to isolate and study temperate bacteriophages in the human gut.
    • “This is a foundational study that changes how we think about and study the viruses within the human gut,” said Jeremy Barr, PhD, professor at the Monash University’s School of Biological Sciences. “We found that compounds produced in human gut cells can wake up dormant viruses inside gut bacteria. This could have major implications for gut diseases like inflammatory bowel disease (IBD), where inflammation and cell death are common.”
  • Per MedPage Today,
    • “There were 176.6 major congenital malformations (MCMs) per 10,000 infants exposed to first-trimester COVID-19 mRNA vaccines, compared with 179.4 per 10,000 infants not exposed to the vaccines.
    • “There were no associations between mRNA vaccine exposure and MCMs by organ system.
    • “There was no difference in the rate of stillbirths between pregnant women who received mRNA vaccines and those who didn’t (both 0.4%).”
  • Per BioPharma Dive,
    • “A regimen pairing Johnson & Johnson’s dual-pronged multiple myeloma drug Tecvayli with an older medication, Darzalex, staved off disease progression and death better than Darzalex and a standard drug combination in a Phase 3 trial, the company said Thursday.
    • “According to J&J, a panel of independent trial monitors recommended halting the study early after the Tecvayli regimen met its objectives at an early data check. Researchers have been following trial volunteers for an average of about three years.
    • “The trial assessed the Tecvayli combination in people whose multiple myeloma had progressed after one to three prior treatment lines. Tecvayli is currently available to patients who’ve previously received at least four lines of care. That clearance, awarded in 2022, was an “accelerated” approval, which requires confirmation from a trial that demonstrates a survival benefit.”
  • and
    • “Final results from a years-long study show that Novartis’ Fabhalta medicine can significantly slow the decline of kidney function in patients with IgA nephropathy, the Swiss drugmaker said Thursday.
    • “The trial, known as Applause-IgAN, compared twice-daily doses of Fabhalta with a placebo in patients with the rare kidney disease. After two years of treatment, researchers found that the patients on Fabhalta had significantly better results on a scale that measures how well kidneys filter waste from the blood.
    • “Fabhalta had already won accelerated approval from the Food and Drug Administration in 2024 based on initial data showing the drug could reduce protein in the urine of patients with the condition. With the final study results in hand, Novartis now plans to seek a full, traditional approval of the medicine for IgAN patients next year.”
  • and
    • “In March 2023, investors could buy a share of Praxis Precision Medicines for about the same price as a dollar-menu item at a fast-food restaurant. The Boston-based biotechnology company had just suffered a major setback with one of its experimental medicines, which failed a key study testing it as a treatment for a neurological disease that causes involuntary shaking.
    • “Praxis, as drug companies often do, found enough silver linings in the data to push its medicine forward. The company consulted with the Food and Drug Administration that summer and began enrolling two late-stage trials that fall. By February 2025, a group of independent experts were telling Praxis the first of those trials looked unlikely to succeed. It decided to continue anyway.
    • “That confidence appears to have paid off, as Praxis on Thursday disclosed that both of its studies met their main goals. The company now plans to submit an approval application to the FDA by early 2026. Its share value, which got buffed in late 2023 from a 1:15 stock split, more than tripled on the announcement, peaking at $200 Thursday afternoon.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • ‘New York City-based Montefiore Health System and Garnet Health have signed a letter of intent for Garnet to join the academic health system through a strategic affiliation. 
    • “Garnet Health, a three-hospital system headquartered in Middletown, N.Y., serves more than 500,000 residents across New York’s mid-Hudson and Catskills regions.
    • “The proposed transaction would expand Montefiore’s presence in the Hudson Valley and strengthen Garnet Health’s clinical services, specialty care offerings and long-term sustainability.
    • “Montefiore, which operates 10 hospitals and more than 200 outpatient sites, described the deal as a natural fit.”
  • and
    •  “Already-strained emergency departments are not only projected to experience more volume in the near future, but also more clinical cases requiring immediate attention, according to a Vizient Sg2 report published Oct. 15.
    • “Vizient, which works with hundreds of U.S. hospitals and other healthcare providers, estimates a 5% increase in ED visits between 2025 and 2035. Urgent visits are projected to remain stagnant while emergent cases — those requiring immediate action — are expected to rise 8% over the decade. 
    • “Over the past year, emergent visits increased 6% while urgent visits stabilized. Sixty-five percent of ED visits between the third quarter of 2024 and the second quarter of 2025 were emergent. 
    • “While urgent visits have stabilized, continued efforts to redirect low-acuity patients to alternative care sites remain essential to improving ED throughput and preserving capacity for higher-acuity cases,” the report said.”
  • and
    • “Physician compensation rose more in 2025 than in any year over the past decade, largely due to clinician supply and demand imbalances, according to a survey from SullivanCotter. 
    • “Published Oct. 15, the survey is based on data from more than 500 healthcare organizations representing approximately 231,300 physicians across 232 specialties. It found that median physician total cash compensation — base salary plus incentives — grew year over year across all major specialty categories.
    • “Among those, adult medical specialties saw the largest year-over-year increase at 7.5%, as physician workforce expectations continue to evolve.”
  • Modern Healthcare discusses why private equity wants in on outpatient cardiology.
    • “Private equity investors are training their attention on cardiology — a fast-growing specialty rife with financial opportunity. 
    • “Investor interest in outpatient cardiology practices has grown in recent years, driven by a fragmented market landscape facing financial pressures and an aging population of patients and providers. The Centers for Medicare and Medicaid Services also is reimbursing more cardiac procedures in ambulatory settings, which has been an impetus for private equity firms to make investments.
    • “The growing number of transactions and operational changes hasn’t quieted skepticism about whether the investments are a win for patients. There is limited post-acquisition data on quality, patient volumes and costs of care at individual cardiology practices. The data on private equity’s overall impact on the industry paints a bleak picture.
    • “Private equity is here in cardiology. It’s not going to go away,” said Dr. Samuel Jones, director of inpatient electrophysiology at the Chattanooga Heart Institute and member of the American College of Cardiology’s Board of Trustees.”
  • Healthcare Dive points out,
    • “Prospect Medical Holdings has tentative deals to sell two of its shuttered hospitals in Pennsylvania — Chester Medical Center and Springfield Hospital — for a combined $13 million, according to documents filed to bankruptcy court last week. 
    • “Chariot Allaire Partners has offered $10 million for Crozer-Chester Medical Center, while Restorative Health Foundation and Syan Investments together have offered $3 million for Springfield Hospital.
    • “Closing the deals would allow Prospect to finally rid its hands of failed Crozer Health, following years of conflict with state regulators over its management practices and failed sales attempts. Crozer fully shuttered this spring.”

From the artificial intelligence front,

  • Healthcare Dive lets us know,
    • “Google Cloud revealed several artificial intelligence partnerships with healthcare organizations on Thursday, including for projects that summarize clinical notes and automate prior authorizations. 
    • “The partnerships come as more healthcare and life science firms are deploying AI agents, or advanced tools that can more autonomously plan and perform tasks, according to a Google Cloud survey of 605 leaders released Thursday. Forty-four percent of executives said their organizations were actively using agents, with 34% reporting they use 10 or more agents.
    • “For example, Hackensack Meridian Health built multiple AI agents using Google’s generative AI technology, including a tool that can recap patients’ medical records for doctors.
    • “The health system’s note summarization agent has helped more than 1,200 clinicians generate more than 17,000 summaries since it went live in June, according to a press release.”
  • and
    • “Microsoft is expanding its artificial intelligence-backed clinical assistant to include functionality geared towards nurses, the technology giant said Thursday. 
    • “Dragon Copilot, Microsoft’s upgraded AI assistant tool launched this spring, will be able to record nurses’ interactions with patients and help document their care, as well as access medical content or health system protocols, the company said.
    • “Microsoft collaborated with multiple health systems to build the update focused on nurses’ documentation workflow. “Physicians document very differently,” said Mary Varghese Presti, corporate vice president and chief operating officer at Microsoft Health and Life Sciences. “What we built here for nurses is not a rinse and repeat of that.” 

Midweek report

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

From Washington, DC

  • SHOCKER — STAT News reports,
    • “The Centers for Medicare and Medicaid Services [CMS)] is pausing Medicare payments to doctors, as negotiations tied to the government shutdown drag on. 
    • “CMS announced the pause in a notice on its website but didn’t say when it would end. It’s happening because Congress needs to reauthorize certain Medicare payment programs related to telehealth and rural providers, and that reauthorization has gotten wrapped up in the overall deal to reopen the government.
    • It’s not clear why all physician payments have been cut off rather than just the programs that need to be renewed. CMS did not immediately respond to a request for comment.
    • “An extended payment pause could eventually cause cash flow concerns for doctors, several groups representing providers told STAT — and there are fears that, in some cases, claims could be left unpaid, should the renewal of programs that have lapsed not be made retroactive. Payments for ground ambulance transport services and Federally Qualified Health Centers are also in limbo.
    • “The paused payments include those going back to Oct. 1, when the government shutdown started and several health care programs lapsed.” 
  • WHIPLASH (again from STAT News) — The Centers for Medicare and Medicaid Services said late last night that it was not pausing all Medicare payments to doctors, after a statement hours earlier had asserted that it would. Instead, the agency will only wait to process claims that are related to programs that have expired, such as some telehealth or rural services. 
  • Per the Senate press gallery,
    • “2:55 p.m. October 15 — By a vote of 51-44, the Senate did not invoke cloture on the motion to proceed to H.R. 5371, [the House passed continuing resolution] upon reconsideration.
    • “Democrats voting in favor: Cortez Masto and Fetterman.
    • “Independent voting in favor: King.
    • “Republican voting against: Paul.
    • “Senators not voting: Blackburn, Duckworth, Hagerty, Marshall and Tillis.”
  • Beckers Hospital Review offers four notes on the extension of the government shutdown into a third week.
  • Govexec adds,
    • “More than 150 lawmakers, led by Sens. Tim Kaine, D-Va., Chris Van Hollen, D-Md., and Lisa Murkowski, R-Alaska, on Wednesday demanded that the Trump administration guarantee that furloughed federal employees are granted backpay at the conclusion of the ongoing federal government shutdown, which has entered its third week.
    • “Last week, the Office of Management and Budget floated a theory that the 2019 Government Employees Fair Treatment Act, which automatically provides backpay to furloughed federal workers following appropriations lapses and was signed by President Trump during the 2018-2019 partial government shutdown, merely authorizes Congress to provide backpay after a shutdown. OMB revised its shutdown FAQ document to remove reference to the law’s guarantee, and the Internal Revenue Service revoked shutdown guidance to employees, issued just days prior, that made reference to backpay.” * * *
    • In their letter to [OMB Director Russell] Vought, the lawmakers insinuated that OMB’s stance may be more motivated by politics than a good-faith legal analysis and urged the White House to reaffirm furloughed workers’ right to backpay.
  • OPM has released a description of Federal Benefits Open Season Highlights 2026 Plan Year, which identifies the plans and plan options withdrawing from the FEHBP, the PSHBP and FEDVIP for the 2026 plan year. The as yet unreleased OPM benefit administration letter on program changes also identifies the plans with service area changes, for example.
  • The American Hospital Association News tells us,
    • “Medicare open enrollment for 2026 began Oct. 15 and runs through Dec. 7. During the annual enrollment period, Medicare-eligible individuals can check their status, choose plans or change plans during the open enrollment period, including switching from Medicare Advantage and prescription drug plans to Traditional Medicare. The Centers for Medicare & Medicaid Services projects the average monthly premium for MA plans will fall by $2.40 in 2026 to $14.00, while the average standalone monthly total premium for a Medicare Part D prescription drug plan will fall by $3.81 to $34.50. Among other changes this year, out-of-pocket costs for prescription drugs will be capped at $2,100.”
  • CMS reminds us,
    • “Medicare’s Open Enrollment Period is here! Visit Medicare.gov/plan-compare now through December 7 to compare all your coverage options. 
    • “Even if you’re happy with your current plan, it’s important to check for any changes next year. You can also check the star ratings to compare the quality of different health and drug plans.”
  • The Wall Street Journal alerts us that “Big changes Are coming for 2026 Medicare Plans. What You Need to Know. Skinnier benefits, higher premiums and fewer options mean more than a million seniors should shop for new coverage during open enrollment.”
  • Healthcare Dive reports,
    • “CMS Administrator Dr. Mehmet Oz highlighted areas where Medicare Advantage could improve — while reaffirming his support for the privatized Medicare program — during an event organized by the top MA lobby on Wednesday.
    • “Oz’s comments reflect the difficult tightrope regulators in the Trump administration walk as they pursue MA reform, especially in the areas of improper overpayments and prior authorizations, without offending the powerful insurance industry.
    • “I came both to celebrate what you’re trying to do, but also be honest about some of the issues that we’re seeing at CMS,” Oz said during the Better Medicare Alliance’s forum in Washington, D.C. “The opportunities we have if we do this correctly are massive. I see Medicare Advantage as this essential lever arm, this tool that we can use for good — and sometimes not — but if we use it correctly and nimbly, we can do all kinds of things to refine and improve the system.”
  • Medscape notes,
    • “Enrollment in Medicare Advantage was associated with an increased likelihood of receiving an Annual Wellness Visit, especially among racial and ethnic minorities, those with dual eligibility, and those with Alzheimer’s disease and related dementias.”
  • Per Fierce Healthcare,
    • “Fifteen governors unveiled Wednesday a new coalition to coordinate public health efforts in the latest sign of distrust in federal health agencies.
    • “The so-called Governors Public Health Alliance is now the largest alternative public health authority run by states, with leaders representing 129 million Americans, and follows the three-state West Coast Health Alliance and the 10-state Northeast Public Health Collaborative. The new effort is described as complementary to the states’ existing public health mechanisms and in line with the two existing coalitions.
    • “Announcements from several of the governors describe the effort as nonpartisan, though all the current participating leaders are Democrats. The alliance itself is supported by GovAct, a nonprofit and nonpartisan platform for gubernatorial collaborations.
    • “Similar to other states’ efforts, the governors said their new alliance will share best practices and expertise, coordinate on disease surveillance, co-draft public health guidelines and purchase supplies such as vaccines. It will also keep an open dialogue with the global health community while “elevating national considerations for vaccine procurement, policy solutions and more,” according to announcements.”

From the judicial front,

  • The Wall Street Journal relates,
    • “A federal judge temporarily blocked the Trump administration from moving ahead with mass firings of federal employees while the government is shut down. 
    • “Judge Susan Illston issued the temporary restraining order in a ruling from the bench on Wednesday, stopping the government from cutting federal workers at multiple agencies. 
    • “The court record suggested that the Trump administration has “taken advantage of the lapse in government spending and government functioning to assume that all bets are off, that the laws don’t apply to them anymore and that they can impose the structures that they like on the government situation that they don’t like,” said Illston, a Bill Clinton appointee. 
    • “The Trump administration moved ahead on threats last week to lay off federal workers, sending reductions in force notices, otherwise known as RIFs, to about 4,000 employees at more than a half-dozen federal agencies, including the departments of Treasury, Health and Human Services, Education and Commerce.”
  • Healthcare Dive informs us,
    • “A federal judge has thrown out a last-ditch effort from Humana to get the government to recalculate its Medicare Advantage star ratings for 2025.
    • “On Tuesday, Judge Reed O’Connor of the Texas Northern District Court ruled that the CMS acted legally in downgrading Humana’s stars based on unsuccessful customer service calls.
    • “O’Connor dismissed the case with prejudice, meaning it can’t be refiled but could still be appealed. A spokesperson for Humana said the company is “disappointed” with the ruling and is considering “all available legal options.”
  • Sequoia explains how to navigate the legal landscape of gender-affirming care in employer health plans.

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP points out,
    • “A new update from the South Carolina Department of Health (SCDH) says the state’s measles outbreak has grown by 5 cases, to 16 infections since July, including 12 cases that are part of an Upstate outbreak that has seen two schools send hundreds of unvaccinated kids home after exposure to the highly contagious virus.
    • “The cases come as the US total climbs to 1,596 confirmed infections.”
  • Medscape discusses a new COVID variant known as Frankenstein.
    • “According to the World Health Organization (WHO), this rise is associated with the emergence of a new SARS-CoV-2 variant, XFG, also referred to as “Frankenstein,” because it is a recombinant of two other variants, LF.7 and LP.8.1.2.
    • “XFG has been classified by the WHO as a variant under monitoring since 25 June 2025 and is growing globally. Current evidence suggests that the additional public health risk is low worldwide, and approved COVID vaccines are expected to remain effective against this variant to prevent symptomatic and severe disease.”
  • The Washington Post lets us know,
    • “Health officials in New York state confirmed the first locally acquired case of chikungunya in the United States in six years. The virus is rarely fatal, and most patients recover in a week, but in some cases, it can cause prolonged and debilitating joint pain.
    • “It is also the first locally acquired case of chikungunya in New York, the state’s health department said. A resident of Nassau County, who was not named, had not reported any foreign travel before experiencing symptoms in early August, the county’s health department said. County officials said on Tuesday they had not found chikungunya in local mosquitoes, adding: “There is no evidence of ongoing transmission of the virus and the risk to the general public remains low.”
  • Per Healio,
    • “Alcohol-induced deaths increased by 89% from 1999 to 2024, peaking in 2021.
    • “These deaths rose by 255% among women aged 25 to 34 years and by 188% among men aged 25 to 34 years.”
  • and
    • “Mean BMI increased for premenopausal women and postmenopausal women in the U.S. from 1999 to 2018.
    • “The 50th percentile BMI for premenopausal and postmenopausal women peaked at about age 60 years.”
  • Per Medscape,
    • “Egg- and non-egg-based influenza vaccines showed equivalent protection against laboratory-confirmed influenza‑like illness and related hospitalizations among healthy adults in the military health system. However, recombinant influenza vaccine achieved higher seroconversion rates across all influenza subtypes.”
  • and
    • “Penicillin V was as effective as amoxicillin for treating pneumonia in primary care, with similar rates of hospitalization for lower respiratory tract infection or all-cause mortality within 28 days of starting antibiotic therapy, making it a viable alternative in primary care settings with similar resistance patterns.”
  • Per Fierce Pharma,
    • “GSK’s ViiV Healthcare and its bimonthly pre-exposure prophylaxis (PrEP) medicine Apretude had to make room for another long-acting PrEP option this summer, when rival Gilead Sciences rolled out Yeztugo to much fanfare.
    • “But despite Yeztugo’s twice-yearly convenience factor, unprecedented efficacy performance in trials and award-winning pedigree, GSK has long maintained that one aspect of the rival drug’s clinical profile would block it from snatching the entire long-acting PrEP market.
    • “Now, armed with a new open-label crossover study, the company can back up its theory that the injection-site reactions from Gilead’s drug may give some potential users pause.
  • Per BioPharma Dive,
    • “Eli Lilly released the results of two new Phase 3 trials of an experimental GLP-1 pill that the company says could become a “foundational treatment” for type 2 diabetes.
    • “The medicine, orforglipron, succeeded on all primary and key secondary endpoints in the studies of diabetes patients, Lilly said Wednesday. One trial, Achieve-2, compared orforglipron with dapagliflozin, sold by AstraZeneca as Farxiga. The other, Achieve-5, tested orforglipron against a placebo in patients also taking insulin.
    • “The Indianapolis-based drugmaker plans to submit global regulatory applications for orforglipron in the treatment of type 2 diabetes next year. The company said it will seek approval of the drug as an obesity medication by the end of 2025.”
  • Beckers Hospital Review identifies “six new drug shortages and discontinuations, according to drug supply databases from the FDA and American Society of Health-System Pharmacists.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit Health and the University of Pittsburgh Medical Center have signed a non-binding letter of intent to integrate Steubenville, Ohio-based Trinity Health System into UPMC. 
    • “CommonSpirit and Trinity Health leaders began a search earlier this year to find a regional health system that would add to Trinity’s offerings, according to a Wednesday news release.
    • “The health systems will work toward a definitive agreement over the next several months.” 
       
  • Healthcare Dive informs us,
    • “CVS has completed a deal to buy 63 Rite Aid and Bartell Drugs stores in Idaho, Oregon and Washington. As part of the deal, which comes five months after Rite Aid filed for bankruptcy, CVS will also acquire the customer prescription files of 626 locations across 15 states.
    • “The agreement was first announced in May, though CVS at that time planned to acquire 64 locations and 625 prescription files. The transfer of assets was approved by a bankruptcy judge later that month.
    • “CVS is also bringing on more than 3,500 employees from the defunct chain and has made “targeted investments” in existing CVS locations to meet the needs of new shoppers. That includes adding more support and improving training programs for associates.”
  • The New York Times reports,
    • “For years, Democrats and Republicans have sounded the alarm about America’s dependence on China for medicines. An analysispublished on Wednesday shows just how deep that reliance is at the earliest stage of the drug manufacturing process: Nearly 700 U.S. medicines use at least one chemical solely sourced from China.
    • “As tensions between Washington and Beijing have escalated in recent years, experts fear that this reliance could leave American patients vulnerable, especially if a trade war or future pandemic prompts China to curtail exports. Supply shortages for some generic medicines have already grown common.
    • “The new data, from U.S. Pharmacopeia, a nonprofit that tracks the drug supply, identified the origins of chemicals used to make medicines. The analysis found that China was the sole supplier of at least one chemical in widely used antibiotics, like amoxicillin, and generic drugs for heart problems, seizures, cancer and H.I.V.
    • “One example is the allergy-relief medicine best known by the brand name Benadryl. (Kenvue, the company that sells Benadryl, did not return a request for comment.)
    • “There is almost no production of these chemicals in the United States because making them is dirty and labor and other costs make manufacturing them unprofitable. Chinese factories, by contrast, don’t face the same environmental restrictions and can make these raw materials inexpensively.”
  • Fierce Healthcare notes,
    • “Blue Cross Blue Shield Global Solutions is teaming with Carrot to offer family planning and fertility services to expatriate members across the world.
    • “BCBS Global Solutions, jointly owned by 15 Blue Cross plans and Bupa Global, will connect members globally with Carrot’s array of hormonal and family planning care, ranging from fertility, pregnancy, postpartum, surrogacy, adoption, menopause and low testosterone management. The organization shared the announcement exclusively with Fierce Healthcare.
    • “Through Carrot’s platform, members can access a network of more than 17,000 vetted providers worldwide, plus services that are available in more than 25 languages or through live translation across 300 languages.
    • “Following our recent rebrand, this partnership with Carrot marks another step forward in our commitment to deliver innovative global healthcare solutions,” said Simon Jackson, Chief Growth Officer of BCBS Global Solutions, in the announcement.”
  • Per Fierce Pharma,
    • “With sales of potential blockbuster Lokelma scaling up, AstraZeneca is bolstering its production of the hyperkalemia treatment with a $445 million injection of funds.
    • “The investment will increase the capabilities of AZ’s manufacturing facility in Coppell, Texas, which is the company’s lone site in the world that produces Lokelma.
    • ‘AZ will build a new 9,000-square-foot building at the complex and add two production lines, doubling its capacity to manufacture the treatment. The investment also will support upgrades for drug substance production and lab testing, as well as additional warehouse and administrative space, the company said in an Oct. 15 release.”

From the artificial intelligence front,

  • Fierce Healthcare offers a look inside Elevance Health’s AI strategy.
    • “The pace of digital innovation in healthcare is rapidly accelerating, and, for the team at Elevance Health, a simple mantra remains at the heart of its efforts: Keep the member at the center.
    • “Ratnakar Lavu, executive vice president and chief digital information officer at Elevance, told Fierce Healthcare in an interview that the perspective is born from his experience in consumer industries like retail, where many patients form their expectations for digital experiences.
    • “Digital platforms can make things simpler and more personalized for members, he said, but there’s also a risk of deploying new tech just for the sake of it.
    • “My obsession always has been, let’s focus on the consumer, the member, and in our case, the patient, and keep them at the center of how we think about overall transformation,” he said. “Because it’s not technology for the sake of technology, it is really trying to focus on the experiences that we want to bring to life.”
  • STAT News reports,
    • “Lyra launches ‘clinical grade’ chatbot amid growing concern about mental health and AI
    • The company is the largest to launch a generative AI product as a part of ongoing therapy treatment.”
  • and
    • “As more nurses deliver primary care, an AI startup wants to guide their decisions and training> Altitude has raised $5.4 million to develop its platform and expand customer base.
  • MedTech Dive shares “five AI takeaways from AdvaMed’s conference. Medical device firms discussed privacy, regulations and prioritizing projects as AI becomes more prevalent in the industry.

Tuesday’s report

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Obesity, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Senate returned to Capitol Hill today and is scheduled to hold its eighth vote on the House-passed continuing resolution but is expected to fall short of the 60 votes required to pass the CR. Formal negotiations toward a deal still have yet to take place. The House, which has been out of session since passing the CR Sept. 19, remains out this week with no plans to return.”
  • The FEHBlog adds that today’s Senate eighth vote on the House passed continuing resolution did fall short of the 60 votes required to pass the CR. The vote was 49 ayes and 45 nays. The Majority Leader switched his vote from aye to nay to preserve his ability to bring this cloture motion back to the floor.
  • CNBC informs us,
    • “The government shutdown will delay a key announcement that affects millions of Social Security beneficiaries — just how much their benefit checks will increase in 2026.
    • “The Social Security cost-of-living adjustment for next year will be revealed once September consumer price index data, which was slated for release on Oct. 15, is available. Due to the federal government shutdown, the CPI release has been pushed to Oct. 24.
    • “The Social Security Administration (SSA) will use this release to generate and announce the 2026 cost-of-living adjustment (COLA) on October 24 as well,” a Social Security spokesperson told CNBC.com via email.” * * *
    • “Experts estimate the benefit increase may fall in the range of 2.7% to 2.8%, based on the most recent government inflation data. Such an increase would push the average retirement benefit up by about $54 per month.”
  • Fierce Healthcare relates,
    • “The Purchaser Business Group on Health is launching a massive data project that aims to make it easier for employers to get their arms around what they’re actually paying for healthcare.
    • “The organization unveiled its Health Care Data Demonstration Project on Tuesday morning, which is built on both hospital price transparency data and transparency in coverage information, establishing tools that employers can use to more accurately determine a “fair price” for healthcare services.
    • “The demonstration leans on five large employers, including aerospace company Boeing and technology firm Qualcomm, PBGH said in an announcement. Armed with more accurate pricing data, employers can see where their health plans or third-party administrators may be falling short in managing costs.”
  • WTW identifies ten “surprising expenses” that can be reimbursed from an employee’s health savings account.
  • Life Health Advisor lets us know,
    • “Equitable, a leading financial services organization and principal franchise of Equitable Holdings, Inc. (NYSE: EQH), has announced new findings from a national survey of more than 1,000 consumers, highlighting key financial trends shaping how Americans engage with their workplace benefits.
    • “The survey revealed that 80% of Americans worry that an unexpected medical expense could derail their financial goals, with more than a quarter of this group indicating that a bill under $1,000 would cause financial hardship. Younger generations are especially anxious — 89% of Gen Z and millennials said an unplanned medical cost would disrupt their financial plans, compared to just 56% of baby boomers.
    • “Since employer-sponsored health insurance often does not cover the full cost of medical care, workers frequently pay out of pocket for uncovered expenses. When respondents were asked how they would pay for a costly and unplanned medical bill, 48% said they would set up a payment plan, 31% would use general savings, and 28% would rely on credit cards. Notably, 12% would take a hardship withdrawal from their retirement account, with millennials (20%) and Gen Z (16%) more likely to do so than Gen X (6%) or baby boomers (3%).
    • “Americans’ health and wealth needs are inextricably connected. An unplanned visit to the hospital can put a person’s long-term financial security at risk — especially if they need to tap into retirement savings to cover a costly medical bill,” explained Stephanie Shields, Head of Equitable’s Employee Benefits business. “While some approach open enrollment as a chore each year, it is important to take the time to understand all the benefit options offered by your employer. This investment can protect your health and your financial well-being.”
  • Per a PCMA news release,
    • “After more than seven years leading the Pharmaceutical Care Management Association (PCMA) and in the last year of his contract with the organization, PCMA President and CEO Juan Carlos “JC” Scott today announced his decision to step down before the end of the year.
    • “JC has led PCMA during a critical period of transition in health care. He works tirelessly to advocate for the PBM industry and our mission to lower prescription costs for the patients, businesses, labor unions, health plans, and public partners we’re proud to serve,” said PCMA board chairman Adam Kautzner, PharmD, President, Evernorth Care Management & Express Scripts. “We value JC’s role in leading PCMA to where it is today during a time of dynamic changes on Capitol Hill and in the states. As we begin the search for a new head of the association, it is helpful to have JC’s continued guidance in this transition period.”

From the Food and Drug Administration front,

  • Cardiovascular Business points out,
    • “Medtronic has received an important update from the U.S. Food and Drug Administration (FDA) to the labeling of its Endurant stent graft system.
    • “Going forward, the FDA is allowing Medtronic to include clinical evidence related to the treatment of ruptured abdominal aortic aneurysm (rAAA) in the device’s labeling. In addition, Medtronic can now remove the rAAA treatment warning currently required to be included in the instructions for use (IFU) of the Endurant system and other similar devices.
    • ‘The Endurant stent graft system has been used to treat abdominal aortic aneurysms for more than a decade now. It now stands as the first and only endovascular aneurysm repair (EVAR) system to receive this labeling update from the FDA.” 
  • CNN reports,
    • “The US Food and Drug Administration has given clearance to another blood test to help assess Alzheimer’s disease and other causes of cognitive decline, providing a broader understanding of when the disease can be ruled out.
    • “Roche Diagnostics said Monday that its Elecsys pTau181 test, developed in collaboration with Eli Lilly, could be used by primary care physicians to help identify patients who are unlikely to have Alzheimer’s disease, while those with a positive result would be recommended for further testing.
    • “The test is intended for adults 55 and older in the United States who are showing signs or symptoms of cognitive decline.”
  • Per Fierce Pharma,
    • “It appears problems at Novo Nordisk’s recently acquired manufacturing facility in Indiana aren’t going to be solved any time soon. The FDA has tagged the former Catalent facility with an official action indicated (OAI) label, which is the most severe of the three inspection classifications issued by the agency.
    • “The OAI designation—which identifies facilities that are at “an unacceptable state of compliance,” according to the regulator—is bad news for drugmakers who depend on the massive plant in Bloomington for contract manufacturing.
    • “One of those companies is Scholar Rock, which is bidding for FDA approval of its highly anticipated spinal muscular atrophy (SMA) treatment apitegromab. Another is Regeneron, which has two FDA applications pending for eye disease treatment Eylea, which is produced at the site.
    • “In an email, Novo Nordisk acknowledged receiving the OAI status notification on Oct. 9 and said it is in contact with the FDA and its CDMO partners who are affected.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “More children are getting diagnosed with autism than ever before.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. has promised to find out why. The Trump administration has already touted the active ingredient in Tylenol, acetaminophen, as a possible cause, even as doctors and researchers say the link is unproven.
    • “Autism has a strong genetic component, scientists say, and some known risk factors such as older parental age might have contributed to the increase. Some think environmental exposures that haven’t yet been identified could also have played a role. 
    • “But to explain the bulk of the rise — from one in 150 8-year-old children in 2000 to one in 31 in 2022 — many doctors and scientists point to how the diagnosis itself has morphed over time.” * * *
    • “Some researchers and advocates have started using the term “profound” autism to describe cases among children with an IQ of less than 50 or who are minimally verbal or nonverbal. Around 27% of 8-year-olds with autism in the U.S. fit that description, according to the most recent estimates. 
    • “Profound autism cases have ticked upward, but the much bigger rise has been in the children with fewer impairments. Kids referred for an autism evaluation are now less likely to have intellectual disabilities or major language delays, said Amy Esler, a psychologist and professor in the pediatrics department at the University of Minnesota.” * * *
    • “Clinicians also started screening more kids, after the American Academy of Pediatrics recommended it for all children at 18 and 24 months starting in 2007, researchers said.  
    • Rates vary based on location, with federal data from 2022 showing prevalence ranging from 9.7 per 1,000 8-year-olds in Laredo, Texas, to 53.1 per 1,000 in California.”
  • Health Day tells us,
    • “Heart rate variability biofeedback (HRVB) can reduce negative affect, craving, and substance use among individuals in early recovery from substance use disorder (SUD), according to a study published online Oct. 1 in JAMA Psychiatry.
    • “David Eddie, Ph.D., from Massachusetts General Hospital in Boston, and colleagues examined the efficacy of HRVB in the treatment of SUD. The analysis included 115 adults seeking treatment for SUD who were randomly assigned to receive treatment as usual with or without HRVB as a wearable smart patch.”
  • Cigna, writing in LinkedIn, discusses understanding subclinical mental health conditions and their impact on the workplace.
    • “Subclinical mental health conditions like mental load, daily stressors, and mild anxiety are real challenges for today’s workforce. Though less visible than clinical diagnoses, their impact on productivity, morale, and workplace culture is profound. Recent U.S. data shows these issues are common, making it essential for employers to take notice.
    • “By prioritizing mental health before problems become severe, business leaders and HR managers can create healthier, more engaged teams and a more successful organization. The steps are simple but powerful: open communication, flexibility, education, and access to support. Investing in employee well-being isn’t just about compassion; it’s about building a thriving workplace for everyone.”
  • Gastroenterology Advisor notes,
    • “Patients with ulcerative colitis (UC) and Crohn disease (CD) do not have a higher risk for colonic perforation during colonoscopy than patients without inflammatory bowel diseases (IBDs), according to study results published in Digestive Diseases and Sciences.”
  • The American Journal of Managed Care relates,
    • “A 12-year study in China finds that individuals who dine out often face a higher risk of colon and rectal cancers, with obesity playing a mediating role.
    • “Regularly eating meals away from home may carry more than just financial costs. A large cohort study of over 42,000 adults in China found that frequent dining out was significantly associated with an increased risk of colorectal cancer.1The findings suggest a dose-response relationship, with obesity emerging as a key factor that may partially mediate the link between dining habits and cancer risk.
    • “This cohort study is published in Frontiers in Oncology.
    • “Our findings indicated that over half of the Chinese adult population reported dining out at least once per week,” wrote the researchers of the study. “Furthermore, a significant association was observed between frequent dining out and an elevated risk of both colon and rectal cancers when compared to individuals who dined out rarely or never.” * * *
    • “The study found a 2.23-fold increased risk for colon cancer and a 1.79-fold increased risk for rectal cancer among frequent diners.”
    • “Obesity partially mediates the association between dining out frequency and colorectal cancer risk.”
    • “Limitations include self-reported dining frequency, potential unmeasured confounders, and lack of detailed meal data.”
  • Per a UNC Health news release,
    • “A first-of-its-kind clinical study shows that offering modest monthly grocery cards for produce leads to improvements in blood pressure compared to distributing pre-selected boxes of healthy food.
    • “While the link between nutrition and improved health outcomes is well established, there had previously been limited clinical evidence to guide how best to deliver healthy food to individuals facing food insecurity. Funded by Blue Cross and Blue Shield of North Carolina (Blue Cross NC) and conducted by researchers at UNC Health and UNC Schools of Medicine and Public Health, the Healthy Food First trial offers compelling evidence that empowering people to choose the nutritious foods they want can drive meaningful improvements in health outcomes, helping more North Carolina families take steps toward healthier lifestyles.
    • “High blood pressure affects about half of all adults and can lead to serious heart problems. Even though many people get treatment, UNC researchers say more than 75% of Americans with high blood pressure still have readings that are too high, and food insecurity can cause those numbers to go up.”
  • Per Fierce Pharma,
    • “Pfizer’s oncology portfolio has produced a second positive phase 3 trial in HER2-positive breast cancer in the span of about a year.
    • “This time, the drug that delivered the positive readout is Tukysa, a HER2-targeted tyrosine kinase inhibitor that Pfizer picked up in its $43 billion acquisition of Seagen.
    • “When used as a first-line maintenance therapy in patients with HER2-positive metastatic breast cancer who’ve responded to standard induction therapy, Tukysa significantly prolonged the time before cancer progression or death compared with placebo, Pfizer said Tuesday. Both Tukysa and placebo were given in combination with the standard maintenance regimen of Roche’s Herceptin and Perjeta.
    • “The statistically significant and clinically meaningful improvement in progression-free survival means that the phase 3 HER2CLIMB-05 trial has met its primary endpoint, Pfizer said.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are grappling with a shortage of anesthetists and reimbursement cuts, a combination of factors that could limit patient’s access to care and provider’s expansion plans. 
    • “They hope to stave off service reductions by training more CRNAs and simplifying clinician operations, but those strategies may not overcome mounting financial pressures, hospital executives and staffing experts said. Rural areas could be particularly hard hit.
    • “There is serious financial strain on the cost to keep surgery departments going right now,” said Alex Herbison, vice president of physician solutions at staffing firm AMN. “It doesn’t feel sustainable.”
  • Beckers Hospital Review informs us,
    • “CVS Health released its 2025 “Rx Report: Community Pharmacy Reimagined” Oct. 14, highlighting trends in patient expectations, workforce dynamics and technology adoption across the pharmacy sector.
    • “To devise the report, CVS surveyed more than 2,200 customers and 1,060 pharmacists and pharmacy technicians.”
    • The article offers seven takeaways from the CVS report.
  • Beckers Oncology identifies 50 “hospitals and health systems that are opening cancer centers or expanding cancer care services in 2025.”
  • Healthcare Dive reports,
    • “California Gov. Gavin Newsom signed into law new rules on Monday that will place more restrictions on corporate investors’, including private equity firms’, role in healthcare delivery.
    • “The law, Senate Bill 351, prohibits financial firms from having a hand in medical decisions, including determining how many patients clinicians see per hour or what diagnostic tests are appropriate. 
    • “The legislation was drawn up in response to a growing body of evidence that links private equity firms’ involvement in healthcare to higher costs, lower care quality and reduced services, according to the California Medical Association, which backed the bill.” 
  • The Wall Street Journal relates,
    • “Johnson & Johnson plans to separate its artificial hip and knee business into a stand-alone company to be called DePuy Synthes.
    • “J&J said it expects to complete the separation within 18 to 24 months.
    • “This separation is part of J&J’s strategy to focus on higher-growth and higher-margin businesses.”
  • Per BioPharma Dive,
    • “Obesity startup Kailera Therapeutics has raised one of the year’s largest private funding rounds, securing $600 million to support global, late-stage testing of an injectable drug that works similarly to Eli Lilly’s Zepbound.
    • “Bain Capital Private Equity led the Series B round, which also involved Adage Capital Management, investment funds from the Canadian and Qatari governments, Royalty Pharma and other investors. Multiple so-called crossover investors that back private and public drug companies participated, too. 
    • “Kailera and its partner Hengrui Pharma reported in July that the drug, called KAI-9531 or HRS9531, helped people with obesity lose 18% of their body weight on average in a 48-week Phase 3 trial in China, positioning the company to seek approval there. The Food and Drug Administration will likely require a larger, longer, multi-country study before considering a U.S. clearance.”
  • Per Fierce Healthcare,
    • “Oura, the company behind the personal health tracker the Oura Ring, has raised more than $900 million in series E funding, reflecting the company’s rocketing revenue and sales over the last year. 
    • “The company is now worth $11 billion. 
    • “In 2025, Oura Rings soared in sales. The preventive health company has sold 5.5 million smart rings since 2015, and nearly 3 million of those sales occurred in 2025. Its total sales for the year are expected to reach $1 billion between the devices and app subscriptions, according to the company.
    • “The Oura Ring and corresponding app track health metrics like sleep, fertility windows, heart rate, activity and movement and metabolic health.” 
  • and
    • “Digital health platform Hello Heart is launching a new suite of medication management tools for people at risk of heart disease, including an AI assistant for heart health.
    • “Through a connected blood pressure monitor and app, patients can track their blood pressure, cholesterol and medications. Hello Heart aims to reduce the cost of cardiovascular conditions, which, if left untreated, result in costly hospitalizations. Nearly half of the U.S. adult population has hypertension.
    • “The new suite of tools aims to help patients take their medications and manage side effects. It has three components: Nia, an AI assistant; a connected pill box; and chart reviews of high-risk members’ health records by pharmacists.
    • “Medication is the best way to treat high blood pressure, a major risk factor for heart conditions, Edo Paz, M.D., senior vice president of medical affairs at Hello Heart, said in an interview. However, many patients struggle to remember to take their medication or discontinue medications because they don’t perceive a benefit.”
  • Per Fierce BioTech,
    • “Having already established a commercial infrastructure for its oral hereditary angioedema (HAE) drug Orladeyo and eager to pinpoint the source of its future growth, BioCryst Pharmaceuticals has struck a $700 million deal to buy Astria Therapeutics. 
    • “The deal will give the rare disease specialist control of a phase 3 challenger to Takeda’s HAE therapy Takhzyro.
    • “North Carolina-based BioCryst already sells the daily oral capsule Orladeyo, which won approval in 2020 to prevent HAE attacks in patients 12 and older. Forecasting that Orladeyo sales will peak at $1 billion around the end of the decade, the company has been investing in drug discovery and scouting around for deals to drive its next phase of growth.”
  • Per MedTech Dive,
    • Medtronic said Wednesday [October 9] it has completed the first procedures in a U.S. clinical study assessing the safety and effectiveness of its Hugo robot in gynecological procedures.
    • Gynecology is the focus of Medtronic’s third investigational device exemption study in the U.S., after trials for urology and hernia repair met their primary safety and effectiveness endpoints.
    • The total hysterectomy procedures were performed at AHN West Penn Hospital in Pittsburgh. Medtronic expects to enroll as many as 70 people across up to five U.S. hospitals, and include patients having radical, modified radical or total hysterectomies, as well as those being treated for malignancies.