Friday Report

Medical / Rx research

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.

Tuesday report

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

From Washington, DC,

  • Federal News Network reports,
    • “Vice President JD Vance said Tuesday he believes U.S. military members will be paid at the end of the week, though he did not specify how the Trump administration will reconfigure funding as pain from the second-longest shutdown spreads nationwide.
    • “The funding fight in Washington gained new urgency this week as millions of Americans face the prospect of losing food assistance, more federal workers miss their first full paycheck and recurring delays at airports snarl travel plans.
    • “We do think that we can continue paying the troops, at least for now,” Vance told reporters after lunch with Senate Republicans at the Capitol. “We’ve got food stamp benefits that are set to run out in a week. We’re trying to keep as much open as possible. We just need the Democrats to actually help us out.”
    • “The vice president reaffirmed Republicans’ strategy of trying to pick off a handful of Senate Democrats to vote for stopgap funding to reopen the government. But nearly a month into the shutdown, it hasn’t worked. Just before Vance’s visit, a Senate vote on legislation to reopen the government failed for the 13th time.”
  • Govexec adds,
    • “William Shackelford, national president of the National Active and Retired Federal Employees Association, wrote in his own letter to lawmakers Tuesday that the so-called “clean CR” passed by the House is a misnomer, in light of House Republicans’ refusal to allow Democratic input into the bill’s contents and the White House’s efforts both before and during the shutdown to impound or otherwise redirect funding, contrary to appropriations law and the 1974 Impoundment Control Act. • • *
    • “From NARFE’s perspective, Democrats should scale back their demands for the extension of ACA subsidies as a condition for reopening the government. And House Speaker Mike Johnson needs to call his chamber back to Capitol Hill, Shackelford argued.”
  • and
    • “The Trump administration on Oct. 21 released a memo to guide agencies on how to implement a directive establishing legally untested processes to speed up the repeal of regulations. 
    • “In April, the president directed agencies to forgo notice and comment requirements when repealing rules that are deemed unconstitutional or unlawful in light of recent Supreme Court rulings that weakened agencies’ regulatory power. When an agency promulgates a new rule, or revokes one, it must seek, respond to and potentially incorporate public comment on the proposal. That process usually takes at least a year. 
    • “The administration, however, argued that it does not have to take this step because of the “good cause” exception in the Administrative Procedure Act, the law that sets rulemaking requirements. The exception provides that agencies do not have to perform notice and comment if doing so would be “impracticable, unnecessary or contrary to the public interest.”
    • “To date, agencies do not appear to be fully maximizing their energy in carrying out these directives,” wrote Jeffrey Clark, acting administrator of the Office of Information and Regulatory Affairs, the White House office that reviews most federal regulations.” 

From the Food and Drug Administration front,

  • MedPage Today relates,
    • “Lawmakers at the helm of the Senate Special Committee on Aging have proposed a sweeping series of changes that could transform the way the government safeguards the quality of essential generic drugs.
    • “Citing a recent ProPublica investigation, the senators said the FDA should alert hospitals and other group purchasers when foreign drugmakers with serious safety and quality failures are given a special pass to send their products to the U.S.” * * *
    • “After a hearing last month, Scott and Gillibrand demanded the FDA provide an immediate accounting of all foreign generic drugmakers allowed to skirt import bans. And last week, they sent a letter to HHS Secretary Robert F. Kennedy Jr. seeking a briefing about the drug supply chain and the risk of shortages. The letter also cited ProPublica‘s reporting about the FDA’s exemptions from import bans, saying they could pose “a threat to drug safety for American consumers.” * * *
    • “HHS, which oversees the FDA, declined to comment about the investigative report or the letter to Kennedy when contacted by ProPublica, saying the agency would respond directly to the senators.
    • “The 34-page report largely focuses on shoring up domestic manufacturing. The senators cited an academic study released this year that found generic drugs made in India were tied to far more hospitalizations, deaths, and other adverse events than the equivalent medications manufactured in the U.S.
    • “We let the industry go offshore for cost reasons without adjusting the regulatory infrastructure to be able to handle it appropriately,” said Ohio State University professor John Gray, PhD, who co-authored the study. “There’s this race to the bottom … that leads to fragility and shortages and also potential quality issues.”
    • Notably, the senators suggested the Department of Defense could help launch a “federal buyer’s market” that prioritizes the purchase of drugs from domestic manufacturers. The federal government, with agencies that include the Department of Veterans Affairs, is the largest purchaser of drugs in the U.S.
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has shared details about a new recall impacting more than 140,000 bottles of a popular statin. This is a Class II recall, which means taking the drug “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
    • “The medication in question is atorvastatin calcium, a generic version of Lipitor manufactured by India-based Alkem Laboratories and distributed by New Jersey-based Ascend Laboratories. The drug is commonly prescribed to help patients lower their cholesterol levels as well as reduce their risk of adverse cardiovascular events. 
    • “According to the FDA, several lots of atorvastatin calcium were recalled due to “failed dissolution specifications.” This means the drug is not dissolving correctly, which can impact its ability to lower a patient’s cholesterol as intended.
    • “Ascend Laboratories initiated the recall back in September. It was classified a Class II recall on Oct. 10. Click here for additional details.” 

From the judicial front,

  • Federal News Network tells us,
    • “The Trump administration’s latest round of federal employee layoffs will remain on hold, for now.
    • “A federal judge in San Francisco granted a preliminary injunction on Tuesday that will indefinitely block the Trump administration from proceeding with widespread reductions-in-force for about 4,000 federal employees, or issuing new RIF notices, while the case proceeds through the court.
    • “U.S. District Court Judge Susan Illston said her preliminary injunction will block the Trump administration from issuing any more RIF notices or implementing RIF notices that have been issued “because of the shutdown.” The preliminary injunction, however, will not block RIF notices that were sent before the shutdown.”
  • ABC News reports,
    • “On Tuesday, more than two dozen states and the District of Columbia filed a lawsuit in Massachusetts suing the Trump administration over the impending loss of SNAP benefits amid the government shutdown.
    • “About 42 million Americans are poised to lose their Supplemental Nutrition Assistance Program (SNAP) benefits when federal funding comes to a halt on Nov. 1. The U.S. Department of Agriculture (USDA) has said it would not use emergency funds to give a lifeline to program funding. The states are seeking to have the court order USDA to use all available funds to keep SNAP benefits funded in November.”

From the public health and medical / Rx research front,

  • The American Hospital Association informs us,
    • “The American Heart Association released a study Oct. 28 that found disruptions to people’s circadian rhythm can increase their risk of cardiovascular disease and other conditions such as obesity, Type 2 diabetes and high blood pressure. The study said that disruptions can be caused by light exposure and other factors such as mistimed sleep, meals and exercise. “Multilevel interventions and policy changes are needed that promote education on proper timing and regularity of sleep-wake cycles and meal schedules and facilitate improvements in, for instance, workplace and neighborhood environments,” the study notes.”
  • Medscape warns
    • Severe obesity (BMI ≥ 40 kg/m²) is no longer rare in clinical practice. According to the CDC, 9.2% of US adults live with class 3 obesity, and prevalence continues to rise, particularly among younger adults. The National Health and Nutrition Examination Survey revealed that 1 in 270 Americans now has a BMI ≥ 60, a category that did not exist until the early 2000s.
    • This shift has profound clinical implications. People with severe obesity face higher rates of cardiometabolic disease, musculoskeletal limitations, and psychosocial distress. In a diverse US database, class 3 obesity was strongly associated with obstructive sleep apnea, type 2 diabetes, and metabolic-dysfunction associated steatotic liver disease (hazard ratios of 10.94, 7.74, and 6.72, respectively). Yet this growing population remains chronically underserved. * * *
    • “The past 5 years have transformed expectations. Powerful new nutrient-stimulated hormone therapies encompassing GLP-1 semaglutide and the dual GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist tirzepatideroutinely produce average weight loss of 15%-23% in clinical trials, with some participants losing > 30% of body weight. These reductions improve type 2 diabetes, steatotic liver disease, sleep apnea, and quality of life. Semaglutide and tirzepatide have also reduced cardiovascular risk in high-risk populations, underscoring obesity treatment as an intervention that both treats and prevents cardiometabolic disease. 
    • “Access and affordability, however, remain challenging. Current medications also appear to have a therapeutic ceiling, renewing interest in and consensus around bariatric surgery for individuals with BMI ≥ 60.” 
  • Per BioPharma Dive,
    • “Merck & Co. may be able to expand use of its kidney cancer drug Welireg after it hit the main goal in two Phase 3 trials in people with less-advanced disease.
    • “In one trial, adding Welireg to Merck’s immunotherapy Keytruda following the surgical removal of cancerous tissue kept people disease-free longer than Keytruda alone. In the other, a combination of Welireg and Eisai’s Lenvima helped delay progression better than Exelixis’ Cabometyx in people who relapsed after treatment with Keytruda.
    • “Study success in the post-surgical “adjuvant” setting could prove especially lucrative for Merck, potentially nearly tripling expected revenue in that line of care to more than $6 billion, Leerink Partners analyst Daina Graybosch wrote in a note to clients.”
  • and
    • “GSK will pay privately held Empirico $85 million for the rights to an experimental therapy that may treat a range of patients with chronic obstructive pulmonary disease, or COPD.
    • “Empirico is currently testing the drug, known as EMP-012, in a Phase 1 clinical trial. Once that research is complete, GSK will take over development and handle regulatory filings and marketing if the medicine wins approval, the two companies said Tuesday.
    • “As part of the deal, Empirico may receive payments of as much as $660 million more from GSK if the drug reaches certain development, regulatory and commercial milestones. Empirico will also be eligible for tiered royalties on worldwide sales.”
  • Genetic Engineering and Biotechnology News discusses the discovery of a new antibiotic Against found in Streptomyces coelicolor that is potent against resistant bacteria. “The next step in the development of the antibiotic will be pre-clinical testing.”
  • Per MedTech Dive,
    • “Medtronic shared three-year data on Sunday for its renal denervation device, Symplicity Spyral.
    • “The company linked the product to significant reductions in two measures of systolic blood pressure.
    • “Researchers published the results in the wake of a consultation about Medicare coverage of RDN, which Medtronic said could drive growth.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth seems to be making progress on righting the ship, beating Wall Street’s expectations in the third quarter and raising its 2025 earnings outlook on Tuesday.
    • “During a call with investors, CEO Stephen Hemsley said the company is on track for “solid earnings growth” next year, citing UnitedHealth’s “operational rigor” and “more prudent pricing.” UnitedHealth is aiming for double-digit growth in 2027, Hemsley said.
    • “UnitedHealth is preparing for significant membership losses next year as it prioritizes this earnings recovery. The company expects to lose about 1 million Medicare Advantage members and shrink its Affordable Care Act enrollment by approximately two-thirds in 2026.”
  • and
    • “Community Health Systems brought in revenues that were in-line with company expectations during the third quarter, aided by a legal settlement, payer mix improvement and the approval of two new Medicaid state-directed payment programs.
    • “The Tennessee-based system reported $3.1 billion in operating revenue during the third quarter, down slightly year over year but still high enough to beat Wall Street’s expectations, according to an analyst note published by Jefferies on Friday.
    • “CHS said it plans to continue its hospital divestiture strategy. More sales are in the works and could close prior to year end, according to executives.”
  • and
    • “HCA Healthcare raised its full-year profit and revenue outlook on Friday after newly approved state supplemental payment programs in the third quarter helped boost the for-profit’s revenues past Wall Street expectations.
    • “The operator now expects revenue between $75 billion and $76.5 billion, and net income between $6.5 billion and $6.72 billion for 2025.
    • “Rising same-facility equivalent admissions and higher surgical volumes also contributed to HCA’s $19.2 billion in revenue for the third quarter — a 9.6% year-over-year increase.”
  • Per Fierce Healthcare,
    • “A strong third quarter has Tenet Healthcare again raising its 2025 guidance and planning an additional $150 million of capital expenditure investments within its hospital segment to fuel future organic growth, according to earnings results announced Tuesday morning.
    • “The public for-profit beat analysts’ consensus estimates for the quarter via a combination of steady demand and volume growth, per-case revenue growth and a tight hold on expenditures such as labor, executives explained to analysts on Tuesday’s quarterly earnings call.
    • “Both of the company’s segments performed well, though it was the acute hospital unit’s outperformance that fueled a $50 million raise to the 2025 adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) outlook range’s midpoint—a bump that follows the summer’s $395 million guidance raise and brings Tenet to an expected 13% increase over 2024’s adjusted EBITDA.”
  • and
    • “It has been a complicated year in Medicare Advantage, and the team at Aetna—the third-largest player in this market—is aiming to double down on what’s worked to navigate the choppy waters.
    • “Jeff Fernandez, president of Medicare at Aetna, joined the company in July but is a veteran of the Medicare Advantage (MA) space, with stints at Humana and Ochsner Health Plan. He told Fierce Healthcare in an interview that while this market is no stranger to headwinds, it’s rare to see so many challenges come together at once.
    • “Public policy changes, utilization fluctuations and competitive dynamics all play a role at one time or another, he said, but “usually, you only have to deal with them one at a time.”
    • “It has injected a lot more volatility into the marketplace for Medicare Advantage,” Fernandez said. “I think Aetna’s view of the world is, well, we’ve got to look at what’s worked in the past, perhaps refine it, make it better and double down on certain things.”
  • Per Beckers Clinical Leadership,
    • “Florida has 15 hospitals included on Healthgrades’ Top 50 Best Hospitals for Surgical Care list, the most of any U.S. state. Healthgrades published its 2026 Specialty Excellence Awards Oct. 28.
    • “Healthgrades evaluated about 4,500 hospitals across 31 procedures and conditions for the awards. The Surgical Care Excellence Award specifically evaluates clinical outcomes across 15 in-hospital surgical procedures: back and neck surgery (except spinal fusion), back and neck surgery (spinal fusion), bowel obstruction, carotid procedures, cholecystectomy, colorectal surgeries, coronary bypass surgery, hip fracture repair, peripheral vascular bypass, prostate removal surgery, resection or replacement of abdominal aorta, total hip replacement, total knee replacement, upper gastrointestinal surgery and valve replacement surgery.
    • “In-hospital complications, in-hospital mortality and 30-day mortality are also factored into Healthgrades’ evaluation.”
    • The article lists the hospitals that made the Top 50 list.
  • Bloomberg Law reports,
    • “Cigna Group’s announcement that it will end the highly criticized practice of accepting back-end drug manufacturer rebates prompted surprised cheers from some corners of the drug supply chain, even as industry observers questioned whether the company’s plans will truly improve transparency and reduce prices.
    • “Cigna’s pharmacy benefit manager subsidiary Express Scripts—one of the nation’s largest PBMs—plans to phase out rebates for its fully insured plans by 2027. The company also plans to phase them out with self-insured employer plans by 2028. Bloomberg News first reported the announcement Monday.” * * *
    • “The Pharmaceutical Research and Manufacturers of America did not say whether it expected drugmakers to lower list prices but said Cigna’s plan is a “step in the right direction that will lower the out-of-pocket costs for patients at the pharmacy.”
    • “CVS Health and UnitedHealth have said they pass through nearly all rebates, though it’s not clear how many of their self-insured plan sponsors pass those rebates to consumers at the point of sale.”
  • Per Beckers Health IT,
    • “CVS Health intends to close 16 Oak Street Health clinics two years after acquiring the senior-focused primary care chain for $10.6 billion.
    • The healthcare giant will shutter the centers by the end of February 2026 and continue to have 230 Oak Street Health clinics across 27 states. CVS is scaling back after originally planning to open 300 of the locations, which serve older adults on Medicare.
    • “The move positions Oak Street Health for sustainable, long-term growth as we continue to navigate external challenges, such as elevated medical costs, CMS risk adjustment model changes and health plan payer dynamics,” a CVS spokesperson told Becker’s. “We continue to believe in Oak Street Health and its proven care model to deliver better clinical outcomes for our patients.”
  • Per Fierce Pharma,
    • “Alongside the U.S. government’s overhaul of the federal vaccine infrastructure, influenza vaccination rates in the country have plummeted below the expectations of a key player in the space. That company, CSL, is now delaying a move to part ways with its vaccine business as a result.
    • “Oct. 28, at its annual general meeting in Australia, CSL’s chairman Brian McNamee and its CEO Paul McKenzie provided investors with an update about the company’s intent to separate out its vaccine division, CSL Seqirus. In August, the company announced its intention to spin off the division into a publicly traded firm on the Australia Stock Exchange by next June, but, now, that will not happen as planned. 
    • “In prepared remarks (PDF) to investors, McNamee explained that “heightened volatility in the current US influenza vaccine market” has caused the company to conclude its “previously proposed demerger timing will not fully capture Seqirus’ value potential.” 
    • “Timing will be revisited when we are confident that market conditions would support the maximisation of shareholder value,” McNamee added, according to the prepared remarks.” 
  • and
    • “Shortly after taking the reins at BioMarin, CEO Alexander Hardy laid out three paths the company could take for its struggling hemophilia A gene therapy, Roctavian. A year after opting to shrink the drug’s commercial reach, BioMarin has now flipped back to option C: a divestiture.
    • “After booking $3 million in third-quarter sales for the $2.9 million drug, the company has decided to pursue “options to divest Roctavian and remove it from our portfolio,” Hardy said in an Oct. 27 earnings press release.
    • “We continue to believe Roctavian has an important role to play in the treatment of hemophilia A and are therefore evaluating out-licensing options for this innovative gene therapy,” Hardy explained. “This decision is consistent with BioMarin’s portfolio strategy and offers the most promising opportunity for ensuring continued patient access to Roctavian.”
    • “While it explores out-licensing opportunities, the company will still make the drug available in its three markets the—U.S., Germany and Italy—and “continue to provide support and monitoring” for those already treated, it said.”

From the AI front,

  • JAMA lets us know,
    • “Question How does referral to a lifestyle intervention exclusively driven by artificial intelligence (AI) compare with referral to a human coach–led Diabetes Prevention Program (DPP) lifestyle intervention?
    • “Findings  In this randomized clinical trial involving 368 adults with overweight or obesity and prediabetes, 31.7% of participants randomized to referral to an AI-led DPP and 31.9% of participants randomized to referral to a human-led DPP group achieved the primary composite outcome (5% weight loss, 4% weight loss plus 150 minutes of physical activity per week, or an absolute hemoglobin A1c reduction of ≥0.2 percentage points with hemoglobin A1c maintained at <6.5% throughout the study duration) at 12 months, a difference that met the prespecified noninferiority criterion of 15%.
    • “Meaning Among adults with prediabetes and overweight or obesity, a fully automated AI-led DPP may be a viable alternative to a DPP led by human coaches.”
  • The Wall Street Journal reports,
    • “Drugmaker Eli Lilly has teamed up with artificial-intelligence chip designer Nvidia to build what the companies say will be the most powerful supercomputer run by a pharmaceutical company to boost the discovery of new medicines.
    • “Lilly, which makes the popular weight-loss drug Zepbound and treatments for diabetes and cancer, said the supercomputer and its AI capabilities will allow it to identify new molecules and to speed up the typical yearslong development timelines. 
    • “Indianapolis-based Lilly also will tap the system for other functions such as improving clinical trials, manufacturing processes and sales.
    • “The companies, which announced the partnership Tuesday, declined to disclose financial terms of the deal. Lilly said some of the Nvidia equipment arrived at the company’s Indianapolis data center over the weekend. Lilly expects the system to be online by January.”
  • MedTech Dive adds,
    • “Johnson & Johnson MedTech will partner with Nvidia, incorporating artificial intelligence into a surgical robot used in kidney stone procedures, the companies announced Tuesday.
    • “The medical device giant will use AI-driven simulation to develop its Monarch platform for urology. For example, simulated clinical scenarios and patient anatomy can be used to model kidney stone procedures.
    • “J&J plans to make the urology platform commercially available in the U.S. in 2026.”

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.”

Weekend update

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

From Washington, DC

  • Federal News Network reports,
    • “Many federal employees are feeling a financial hit, as the second-longest government shutdown drags on with no end in sight.
    • “About 1.4 million federal employees missed a full paycheck this week, according to data analysis from the Bipartisan Policy Center. About half of those employees are furloughed, and the rest are working without pay. * * *
    • More than 13,000 air traffic controllers at the Federal Aviation Administration are among those who are about to miss their next paycheck.
    • “Transportation Secretary Sean Duffy told reporters on Friday that air traffic controllers will see a “big, fat zero” on their next paycheck next Tuesday. He previously said there’s been a slight uptick in air traffic controllers calling out sick amid the shutdown.
    • “Duffy said that, before the shutdown, short staffing accounted for about 5% of flight delays on any given day. He said that during the shutdown, short-staffing accounts for 53% of delays.
    • “You can, and very well may see delays in the system. That’s because our priority is you getting from Point A to Point B and getting there safely. I’m less concerned about you getting there on time.”
    • “Nick Daniels, president of the National Air Traffic Controllers Association, said air traffic controllers are “showing up every single day under immense stress,” which can impact their focus on the job. He said some controllers are taking on second jobs to cover their bills during the shutdown.”
  • Govexec adds,
    • “When the new month flips over,” said a Defense Department civilian employee based in Germany, “I have no idea what I’m going to do.” 
    • “For civilian federal employees stationed overseas, the government shutdown—poised to enter its fourth week after a weekend of inactivity in Congress—is bringing a range of unique challenges. One such difficulty stems from employees not just missing their normal pay, like their domestic colleagues, but also their various government-provided housing allowances and other stipends.” 
  • The Wall Street Journal relates,
    • “Top U.S. and Chinese negotiators sounded a positive note on weekend trade talks, hailing what they called constructive discussions ahead of a meeting between President Trump and Chinese leader Xi Jinping planned for this week.
    • “I think we have a very successful framework for the leaders to discuss on Thursday,” U.S. Treasury Secretary Scott Bessent said after two days of trade negotiations in the Malaysian capital. * * *
    • “Trump arrived in Kuala Lumpur on Sunday for a regional gathering of Southeast Asian leaders, his first stop on a trip that will include Japan and South Korea, where he is expected to meet Xi.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Cancer rates are climbing among people in their 20s, 30s and early 40s. But while researchers are still working to better understand what could be driving the perplexing rise, experts say there are steps young people can take to help lower their risk.
    • “Historically, cancer’s been bad luck, bad genetics,” said Arif Kamal, chief patient officer for the American Cancer Society. “It’s this thing that sneaks up on you when you’re not looking for it, and it affects your life in a way that you couldn’t do anything about.”
    • “A growing body of research, however, has examined how lifestyle choices and environmental exposures contribute to the disease. Those factors, unlike genetics, can be controlled to some degree.
    • “What we’re trying to do is build the healthy habits to keep trouble away over time, and you can do that now to invest in a future with less cancer in it,” Kamal said. “The only way we’re going to continue to bend the curve of the number of people getting diagnosed with cancer is really going to be changing how we live in our 20s and 30s.”
    • Here’s what Kamal and other experts say you can do about the cancers that are rising fastest among younger people, including breast and colorectal cancer.
      • Focus on your health
      • Know your personal and family health history
      • Pay attention to symptoms’
      • Advocate for yourself
  • Per JAMA Network,
    • “Question  What is the relative importance across a diverse set of community factors for explaining county-level differences in screening, prevalence, and mortality rates for breast, lung, prostate, and colon cancers?
    • Findings  In this cross-sectional study including all US counties, random forest modeling found that the relative explanatory importance of community measures on cancer screening, prevalence, and mortality rates differed, both within and across cancers. Geospatial patterns also varied, revealing regional and county-level needs.
    • “Meaning These findings suggest that the relative importance of community factors and specific local and regional needs together can inform prioritization and direct resources to the most opportune focus areas to impact cancer outcomes.
  • Per MedPage Today,
    • “A non-hormonal treatment for menopausal moderate-to-severe vasomotor symptoms that just nabbed FDA approval was safe and well-tolerated up to 1 year of treatment, according to a pooled-data analysis.
    • “It is my great and esteemed pleasure to announced that the FDA just hours ago approved elinzanetant [Lynkuet],” said James Simon, MD, of George Washington University and IntimMedicine Specialists in Washington, in a presentation Friday at the Menopause Society (TMS) annual meeting.
    • “Elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist, “represents another important non-hormonal option that all of us can use in treating our patients with vasomotor symptoms,” he added.”
  • and
    • “Postmenopausal women using hormone therapy (HT) saw significantly greater weight loss while taking the dual GIP/GLP-1 receptor agonist tirzepatide (Zepbound) than their counterparts not using HT, according to a retrospective study.” * * *
    • Ultimately, postmenopausal women using HT had the greatest total body weight loss (TBWL) at 19.9%, reported Regina Castaneda, MD, of the Mayo Clinic Florida in Jacksonville, at the Menopause Society annual meeting. Among postmenopausal women without HT, TBWL was 15.6% (P=0.02). TBWL was 18.7% for premenopausal women and 18.6% for perimenopausal women, neither of which differed significantly from postmenopausal plus HT.
    • Indeed, “tirzepatide led to substantial weight loss across all reproductive states,” Castaneda said. “However, the postmenopausal women using hormone therapy achieved significantly greater weight loss compared to those not using hormone therapy, with outcomes closely resembling those of the pre- and perimenopausal women.”

From the healthcare business front,

  • The Wall Street Journal reports,
    • “Novartis NOVN is acquiring Avidity Biosciences RNA in a $12 billion deal that the Swiss drugmaker said would further boost its long-term focus on treating neuromuscular disorders.
    • “The company on Sunday said it had entered into an agreement to buy Avidity, a San Diego-based biotech. Novartis won’t acquire a separate Avidity subsidiary focused on developing early-stage treatments for heart diseases.
    • “Under the deal, Avidity shareholders would receive $72 a share, a 46% premium to its Friday close. 
    • “Avidity is developing gene-based drugs that use an emerging technology known as antibody oligonucleotide conjugates to deliver RNA treatment to muscles. The company is developing experimental drugs based on the technology to treat forms of muscular dystrophy, a multibillion-dollar market. 
    • “The technology, according to Avidity, promises to take RNA therapies to parts of the body where older classes of drugs couldn’t reach or had trouble reaching.”
  • Per HR Dive,
    • “According to HUB International’s 2026 Benefits Cost Trend report, updated Monday, researchers see the costs of benefits going up — with pharmacy being considered a driving factor.
    • “High-cost drugs, such as GLP-1s and auto-immune medications, were two of several elements in this trend.
    • “Researchers also highlighted increased benefits utilization post-pandemic, especially for mental health and substance abuse services.” 
  • Per Medscape,
    • “We may not be as sexy anymore, but we’re cheaper.” The phrase, coined by Ricardo Cohen, president of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), was repeated several times at the organization’s 2025 World Congress in Santiago, Chile. It encapsulates a growing consensus among experts who perform, research, and advocate for metabolic and bariatric surgery amid the surge in use of GLP-1 agonists and related anti-obesity medications.
    • “Surgical approaches may no longer be as fashionable as pharmacologic treatments for obesity, but they remain more economical and cost-effective, according to David Cummings, MD, professor of medicine in the Division of Metabolism, Endocrinology, and Nutrition at the University of Washington in Seattle. Cummings, who studies the hormonal and metabolic mechanisms underlying the effects of metabolic and bariatric surgery on diabetes and body weight, noted that while GLP-1 receptor agonists are “great” and represent the fastest-growing drug class in medical history, “the problem is they are high cost.”
    • “In the US, semaglutide and tirzepatide cost roughly US$900-US$1350 per month compared with US $17,000-$26,000 for a one-time metabolic surgery. Using one of these drugs for less than 2 years, he said, equals the cost of a Roux-en-Y gastric bypass, “which for most people will solve the problem for the rest of their lives.
  • Per MedPage Today,
    • “Home automatic external defibrillators (AEDs) modestly improve survival in shockable cardiac arrests but are not currently cost-effective.
    • “Equipping all private homes with AEDs would cost over $4 million per quality-adjusted life-year.
    • “Future innovations — cheaper devices and AI-driven risk prediction — could make home AED use feasible.”
  • JAMA Network tells us,
    • “The COVID-19 pandemic placed significant strain on the US health care workforce. Physicians experienced a sudden change to usual practice activities with practice interruptions peaking in April 2020. In 2021, self-reported rates of burnout and intent to leave medicine among physicians spiked. Studies using Medicare fee-for-service (FFS) claims data found no increase in physician turnover in 2020 but did find evidence of age-adjusted physician exits from Medicare during the COVID-19 pandemic.
  • Fierce Pharma informs us,
    • “Turning 18 in the U.S. marks the beginning of legal adulthood, traditionally bringing with it major changes, such as the start of college or a career and, for many, the need to switch from pediatric to adult healthcare.
    • “Particularly concerned about the latter leap is Ipsen, which on Thursday unveiled a new educational initiative dedicated to supporting teenagers and young adults in the transition from their pediatricians to adult care, for which they’re often unprepared.
    • “The “Healthcare Shift” website—unbranded, save for the Ipsen logo at the bottom—encourages young people to “become the CEO of your health” and offers tools and tips for doing so, personalized for those as young as 10 years old and up to 26, marking the point when individuals are no longer allowed to be on their parent or guardian’s insurance plan.”


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.”

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the healthcare business front,

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

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.”

Tuesday report

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

From Washington, DC,

  • Federal News Network reports,
    • As Congress still appears far from reaching a spending agreement to end the partial government shutdown, hundreds of thousands of federal employees are expecting to miss their first full paychecks this Friday.
    • “Many excepted and furloughed federal employees received partial paychecks around Oct. 10, for the pay period that ended Oct. 4 — although they were only paid for workdays through Sept. 30.
    • “But while the shutdown drags on, some members of Congress are looking at other options to try to secure pay and benefits for certain employees impacted by the funding lapse.
    • “One Republican-led bill aims to provide immediate and regular compensation to excepted employees, who are continuing to work throughout the shutdown without pay. Sen. Ron Johnson (R-Wis.), who introduced the Shutdown Fairness Act [(S. 3012)] last week, said while the shutdown remains ongoing, Congress should “at least agree to pay all the federal employees that are forced to continue working.”
    • “The 2025 Shutdown Fairness Act is a permanent fix that will ensure excepted workers and our troops are paid during a shutdown,” Johnson said.
    • “Despite the Republican bill being teed up for consideration in the Senate this week, some Democrats, including House Minority Leader Hakeem Jeffries, have already indicated they would not support the legislation, since it provides pay for only a portion of the federal workforce.” 
    • FEHBlog note — As long as Speaker Johnson can hold his majority in the House, the Democrats
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 21 announced that it has instructed all Medicare Administrative Contractors to lift a hold and begin processing claims dated Oct. 1 and later for those paid under the Medicare Physician Fee Schedule, ground ambulance transport claims and federally qualified health center claims. This also includes lifting holds on telehealth claims that CMS can confirm are for behavioral health services. CMS directed all MACs to continue temporary claims hold that began Oct. 1 for other telehealth services and acute Hospital Care at Home claims, as the shutdown approaches the start of a fourth week.”
  • Federal News Network tells us,
    • “The Office of Personnel Management is eyeing July 4, 2027, to fully launch a new governmentwide human resources system.
    • “In a new request for proposals released Friday, OPM details a much more specific plan of action to modernize and centralize 119 distinct core federal human resources systems across the government.
    • “The ideal ‘to be’ state is a single, pan-government core human capital management (HCM) system that gives the federal government full, real-time visibility into its workforce and drives effective workforce management on behalf of the American taxpayer,” wrote OPM Director Scott Kupor in a blog post on Monday. “Key to this ideal is our hypothesis that one system at governmentwide scale will drive significant per-user cost savings over the current siloed, duplicative, ad-hoc landscape.”
    • “Kupor said these 119 systems and the 44,000 people required to use them cost about $5.5 billion a year to manage, and are costly, error-prone and leads to unnecessary delays in enabling a seamless transition to retirement.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has confirmed that a safety concern it was investigating with Johnson & Johnson MedTech’s Automated Impella Controllers (AICs) has resulted in a Class I recall. The agency reserves Class I recalls for issues that could potentially lead to a serious injury or death.
    • “This latest issue with the Johnson & Johnson MedTech AICs revolves around “purge retainer failures,” including cracks, that customers have experienced during purge disc insertion or removal.”
  • Reuters informs us,
    • “The U.S. Food and Drug Administration has approved a new eye therapy from Glaukos Corp (GKOS.N), giving patients a less painful option to treat a progressive condition that can severely affect vision, the company said on Monday. * * *
    • “The approval makes the therapy, called Epioxa, the first FDA-cleared treatment that does not require removal of the eye’s outer protective layer, known as the corneal epithelium.
    • “Epioxa was approved to treat keratoconus, a condition in which the cornea thins and changes shape over time, making vision blurry and increasing the risk of blindness.
    • “Glaukos said it expects Epioxa to be commercially available in the first quarter of 2026.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Food allergies in children dropped sharply in the years after new guidelines encouraged parents to introduce infants to peanuts, a study has found.
    • “For decades, as food allergy rates climbed, experts recommended that parents avoid exposing their infants to common allergens. But a landmark trial in 2015 found that feeding peanuts to babies could cut their chances of developing an allergy by over 80 percent. In 2017, the National Institute of Allergy and Infectious Diseases formally recommended the early-introduction approach and issued national guidelines.
    • “The new study, published Monday in the journal Pediatrics, found that food allergy rates in children under 3 fell after those guidelines were put into place — dropping to 0.93 percent between 2017 and 2020, from 1.46 percent between 2012 and 2015. That’s a 36 percent reduction in all food allergies, driven largely by a 43 percent drop in peanut allergies.
    • “The study also found that eggs overtook peanuts as the No. 1 food allergen in young children.”
  • The American Journal of Managed Care points out,
    • “Body size and metabolic factors—including body mass index (BMI), basal metabolic rate (BMR), body surface area (BSA), and weight—significantly influence psoriasis severity and response to treatment, a study has found.1 Patients with higher measurements were less likely to achieve strong improvement with biologic therapies, suggesting a critical role for personalized dosing in clinical management, particularly for fixed-dose biologics like ustekinumab.
    • “This multicenter, prospective study is published in Journal of Translational Medicine.
    • “Our findings provide important insights into the interplay between body size, metabolic parameters, and psoriasis,” wrote the researchers of the study. “The observation that higher values of BMI, BSA, BMR, and body weight were more common in individuals with higher educational attainment, males, and those reporting smoking or alcohol use may reflect lifestyle- and nutrition-related influences on metabolic status.”
  • Per Cardiovascular Business,
    • “Back in 2023, the American Heart Association (AHA) coined a new term to describe the close relationships between cardiovascular disease (CVD), kidney disease, type 2 diabetes and obesity: cardiovascular-kidney-metabolic (CKM) syndrome.
    • “CKM syndrome involves nearly every major organ in the body, the AHA explained. Patients with CVD often face a heightened risk of developing kidney disease, type 2 diabetes or obesity. Also, patients with any of those three conditions may face a heightened risk of CVD. 
    • ‘More than two years later, the AHA’s message has yet to make a significant impact on the general public. However, new survey data suggests there is a reason to be hopeful.
    • “According to an August 2025 survey, just 12% of U.S. adults have heard of CKM syndrome. The good news, though, is that 79% of respondents said it is important to know more about the way these different health conditions interact with one another. And 72% indicated they were interested in learning more.”
  • Per MedPage Today,
    • “Maternal respiratory syncytial virus (RSV) vaccination during pregnancy and infant RSV immunization — either alone or combined — appeared to be safe and effective at boosting neutralizing RSV antibodies, according to interim results from a randomized, open-label phase IV clinical trial.”
  • and
    • “Giving oseltamivir (Tamiflu) to children hospitalized with influenza cut their risk of ICU admission by nearly one-third and significantly shortened their lengths of stay (LOS), according to a retrospective cohort study.”
  • and
    • “Patients with metastatic hormone-sensitive prostate cancer (mHSPC) lived significantly longer without disease progression with the addition of radioligand therapy to hormonal treatment, a large, randomized trial showed.”
  • and
    • “Adding another twist to the ongoing debate about the effects of weight-loss drugs on vision, a retrospective cohort study linked GLP-1 receptor agonists to a lower risk of legal blindness in patients with type 2 diabetes and risk for cardiovascular disease.”
  • The Wall Street Journal takes us “Inside Priscilla Chan’s Multibillion-Dollar Wager to Outsmart Disease.” As the initiative she co-founded celebrates its 10-year anniversary, Chan is pursuing a wildly ambitious goal: unlocking the hidden causes of disease.

From the HLTH 2025 Conference

  • Modern Healthcare reports,
    • “Risant Health has reduced care variation by using hospitals’ electronic health records to guide treatment, a model it hopes to expand to other hospitals as the Kaiser Permanente-backed nonprofit venture grows, Geisinger Health, Kaiser and Risant executives said during a Tuesday panel at HLTH.
    • “Risant, which was formed in April 2024 when Kaiser acquired Geisinger and folded it into Risant, has integrated what executives describe as value-based care guides into EHRs. A clinician can select a list of the most common conditions for certain specialties and order evidence-based tests and follow-ups via the EHR.
    • “The guides have helped standardize care across Geisinger hospitals, said Dr. Benjamin Hohmuth, chief medical informatics officer at the Danville, Pennsylvania-based health system.
    • “Whether you live in California, are a Geisinger patient in Pennsylvania or a Cone Health patient in North Carolina, you should be receiving the same care and the bias should lean toward more comprehensive primary care,” he said. “It leads to faster resolution for patient concerns, lower cost sharing for patients and frees up specialty access.”
    • “The new protocols have helped reduce the number of primary care visits associated with specialty referrals by about 7% over the last year at Geisinger, freeing up capacity for about 10,000 annual specialty care appointments, and increased virtual and primary care utilization, Hohmuth said.”
  • and
    • “UnitedHealth Group Inc. is testing a new system to streamline how medical claims are processed, an early example of what the company says is the potential for artificial intelligence to smooth out friction in billing.
    • “The system, dubbed Optum Real, aims to distill health plans’ complex rules around what is covered into information that doctors, and billing staff can use in real time to tell whether a claim is likely to be paid. 
    • “It’s been in place at Allina Health, a 12-hospital system based in Minneapolis, since March, where two departments have used it to connect to UnitedHealthcare, the health conglomerate’s insurance division. It’s already reduced claims denials meaningfully across more than 5,000 visits in Allina’s outpatient cardiology and radiology departments, said Dave Ingham, chief digital and information officer for the hospital group.” * * *
    • “Optum Real is speeding up prior authorization requests and helping some patients get care faster, Allina Health’s Ingham said. It’s also reducing headaches for billing and coding staff by flagging claims that need more documentation, for example, before they’re denied. That lets Allina fix the problem without a lengthy back-and-forth with the insurer.
  • Healthcare Dive notes,
    • “Medical billing tech firm Cedar launched a tool Monday that aims to help patients enroll in and maintain Medicaid coverage as the healthcare sector braces for major cuts to the safety-net insurance program.
    • “The product, called Cedar Cover, identifies patients who may be eligible for Medicaid, reminds beneficiaries of upcoming eligibility checks, helps them manage care denials and connects them to medication co-pay assistance, the company announced at the HLTH 2025 conference in Las Vegas. 
    • “The tool comes months after President Donald Trump signed a massive tax and policy law that includes historic cuts to Medicaid. “This bill is going to directly drive increases in uninsured patient care,” Seth Cohen, president of Cedar, said at HLTH.”
  • and
    • “Generation X and Millennials are more interested in utilizing artificial intelligence tools in healthcare as the two generations are increasingly squeezed by caregiving responsibilities for children and aging parents, according to a survey by PwC. 
    • “More than 70% of Gen X and Millennials are currently using or interested in AI-assisted diagnosis products leveraged and reviewed by doctors, compared with 56% of the total population, according to the report released at the HLTH conference Monday.
    • Additionally, 73% of the two generations are using or interested in AI-backed care navigation tools, compared with 53% of the overall population. “They just have a lack of time,” said Thom Bales, principal and health services advisory leader at PwC. “And so, I think that when you see their openness, it is a call to simplifying their life.”
  • Per Fierce Healthcare,
    • “Oscar Health has unveiled its slate of plans available for the 2026 open enrollment window, including a new product launch designed for members who are navigating menopause.
    • “The plan, called HelloMeno, was built in partnership with Elektra Health, a virtual menopause care provider, and offers $0 primary care, gynecologist and behavioral health visits. Members who enroll in this plan option will also receive no-cost labs, hormone therapy, insomnia medications and bone density scans, per an announcement.
    • “Through Elektra, members can connect to its network of experts at any time and are estimated to save $900 per year on their healthcare costs. The plan also allows for low-cost treatment options for autoimmune conditions like rheumatoid arthritis or Crohn’s disease.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance posted revenue and profit growth in the third quarter as the Indianapolis-based insurer brought in higher premiums and kept medical costs for its members in check.
    • “Elevance raked in net income of $1.2 billion on revenue of $50.1 billion in the quarter, up 17% and 12% year over year, respectively. Elevance’s stock ticked up in premarket trade after the results were released Tuesday morning — but it dropped again after executives implied that profit growth could shrink in 2026 during a call with investors later in the morning.
    • “Elevance said it expects a decline in Medicaid margins as state payment rates continue to not cover members’ medical costs — a bad sign for other managed care companies with a large presence in the safety-net insurance program, like Centene and Molina. Elevance also plans to invest “several” hundred million dollars in its health services division Carelon, artificial intelligence capabilities and Medicare Advantage star ratings, which could stifle earnings growth next year.”
  • Per MedTech Dive,
    • “Hologic said Tuesday that it has agreed to be acquired by funds managed by Blackstone and TPG in a take-private deal valuing the company at up to $18.3 billion.
    • “Hologic, which makes diagnostic tools including mammography machines and cervical cancer screening tests, would be delisted from Nasdaq upon completion of the transaction. The company would keep its brand and current headquarters in Marlborough, Massachusetts.
    • “The acquisition is expected to close in the first half of 2026, subject to shareholder and regulatory approval. Hologic’s board unanimously approved the deal.”
  • Beckers Hospital Review shares a non-exhaustive list of “72 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2025,” and offers a look at Microsoft’s healthcare moves.
  • The International Foundation of Employee Benefit Plans offers it medical stop loss premium survey while Brown and Brown posts its 2025 PBM industry and market update.
  • Healthcare IT News lets us know that the American Medical Association has created a new Center for Digital Health and AI.  “The AMA says the new initiative is designed to ensure physicians are involved in the development and deployment of artificial intelligence technologies and to help shape AI policy conversations.”