Monday report

Federal employment benefits

Monday report

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

From Washington, DC,

  • The Hill reports,
    • “The Senate on Monday is holding a series of votes to possibly pass the proposal that could reopen the federal government. 
    • “Monday’s series, which will include up to eight votes, kicked off shortly before 6 p.m. and will conclude with a vote on final passage.
      • FEHBlog note — The Senate did pass a Sen. Susan Collins substitute to the HR 5371 which will go back to the House for a vote perhaps as early as Wednesday. Here is a link to a later Monday Hill report.
    • “Speaking at the White House earlier Monday, President Trump indicated he would back the Senate deal. The bill will still need to pass the House if the Senate votes to advance it.”
  • Federal News Network adds,
    • “The Senate’s initial agreement toward ending the longest-ever government shutdown includes provisions that would secure back pay for all federal employees, as well as reverse the Trump administration’s recent reductions in force.” * * *
    • “The Senate’s legislation over the weekend would also compel agencies to reverse all reduction-in-force actions that have taken place since the shutdown began. About 4,200 federal employees across government received RIF notices in mid-October, following guidance from the White House that encouraged agencies to move forward with layoffs in the event of a funding lapse.
    • “Most, but not all, of those RIF actions are currently on hold due to a preliminary injunction granted by a district court judge last month. Federal unions are suing the Trump administration over the layoffs, alleging that they violate the Administrative Procedure Act.”
    • “The Senate’s tentative agreement would also temporarily bar the Trump administration from conducting further RIFs until late January.”
  • Healthcare Dive tells us,
    • “House Democrats introduced a bill on Friday to repeal a CMS innovation center payment model that will add artificial intelligence-backed prior authorization for some services in Medicare. 
    • “The Wasteful and Inappropriate Service Reduction, or WISeR, model will implement prior authorization in six states starting in January. The CMS last week announced health technology companies that will administer the model.
    • “The six Democrat representatives behind the legislation say WISeR will add red tape and limit access to care for Medicare seniors. “It is not an exaggeration to say that the requirement of prior authorization for traditional Medicare services will kill seniors,” said Rep. Mark Pocan, D-Wis. “Not only that, but the use of AI in determining whether or not treatment is necessary is extremely reckless.”
  • Govexec informs us,
    • “The federal government’s backlog of pending retirement claims hit the highest level since the COVID-19 pandemic last month, as tens of thousands of federal workers who accepted the Trump administration’s so-called deferred resignation program.
    • “While January and February are traditionally the busiest months for processing federal employees’ retirement applications, the deferred resignation program, stemming from Elon Musk’s controversial “fork in the road” email, created a new logjam last month, as most who agreed to leave federal service through the initiative did were paid through Sept. 30. A second tranche is expected next January, as some DRP participants were allowed to remain on paid leave through the end of the calendar year in order to reach retirement eligibility.”
    • “All told, OPM received 20,344 new retirement claims in October. The agency processed 8,751 applications during the same time period—an increase over September’s 7,902 despite the ongoing government shutdown—causing the agency’s backlog to balloon to 34,587 pending claims.”
  • Kevin Moss, writing in Govexec, offers advice on how to assess choices created by the Federal Benefits Open Season, which began today.
    • “From rising premiums to fewer plan choices, this guide walks you through reviewing benefits, checking provider networks and using tax-advantaged accounts to keep your healthcare costs in check next year.”
  • OPM Associate Director for Healthcare and Insurance Shane Stevens also gives Open Season advice on You Tube.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration said manufacturers should remove black box warnings on hormone-replacement therapy drugs, citing clinical trials showing no association with increased breast cancer risk.
    • “The black box warnings may have kept many women away from what life-changing treatment could be, the head of the FDA said Monday in an opinion piece published in The Wall Street Journal.”
  • MedTech Dive lets us know,
    • “MMI said the Food and Drug Administration approved an investigational device exemption to study a microsurgical intervention for Alzheimer’s disease using the company’s Symani robotic platform.
    • “The REMIND study will evaluate the safety and feasibility of the procedure to improve drainage of neurotoxins, such as amyloid beta and phosphorylated tau, from the brain in patients with mild to moderate Alzheimer’s disease and obstruction in the deep cervical lymph nodes of the neck.
    • “The study’s primary endpoint is device-related serious adverse events through 30 days after the procedure. Additional endpoints include biomarker and imaging changes, and cognitive assessments through six months.”

From the public health and medical / Rx research front,

  • PlanSponsor reports,
    • Four industry experts attending the Milken Institute’s Future of Health Summit 2025 noted that as Americans live longer, the challenge is not just adding years to their lives, but making sure that time includes quality, health and financial security.
    • During the panel, “The Longevity Equation: Integrating Healthspan and Wealthspan,” the speakers explored innovative strategies and systems intended to help close the gap between what people need and what the current system delivers, given today’s demographic realities.
    • “It’s great that people are living longer, but it’s important to acknowledge the disparities between their wealth span, lifespan and health span,” said Alberto Casellas, the executive president and CEO of health and wellness at Synchrony Financial. “We haven’t spoken enough about saving for [their] health.”
  • The American Medical Association lets us know what doctors wish their patients knew about sleep apnea.
  • Per Health Day,
    • “Women diagnosed with advanced breast cancer can now expect to live an extra six or seven months compared to about a decade ago, researchers report.
    • “This increase in survival time coincides with the development of more effective treatments for advanced breast cancer, as well as wider improvements in diagnosis and quality of care, researchers said.
    • “In particular, women with breast cancers driven by known biological factors have seen a dramatic improvement in their outlook, thanks to better targeted therapies.
    • “Survival time for patients with advanced breast cancer, where the cancer has spread to other parts of the body, is much lower compared to early breast cancer,” senior researcher Dr. Fatima Cardoso said in a news release. She’s president of the Advanced Breast Cancer Global Alliance in Lisbon.
    • “The major treatments for this stage of breast cancer are systemic therapies, like hormone therapy, chemotherapy and targeted therapy, that aim to kill cancer cells wherever they are growing in the body,” Cardoso said. “In the last 15 years, we have seen a number of new systemic therapies developed and become available to some patients.”
  • Biopharma Dive relates,
    • “An experimental and closely watched drug for multiple sclerosis has delivered positive results in two late-stage clinical trials, giving its developer confidence it could change how the disease is treated.
    • “Roche said Monday that the drug, called fenebrutinib, hit the main goal of a trial focused on the most common, “relapsing” form of MS. According to Roche, participants taking fenebrutinib as opposed to Sanofi’s Aubagio showed a significant decrease in the average number of relapses — periods where neurological symptoms flare up or worsen — experienced in a year. A second, similarly designed experiment should produce results in the first half of 2026.
    • “Additionally, fenebrutinib succeeded in a separate study that enrolled nearly 1,000 people with “primary progressive” MS. The drug was “non-inferior” at slowing the disease compared to Roche’s Ocrevus, a blockbuster product and the only approved therapy for this more severe kind of MS.”
  • Per MedPage Today,
    • “In a phase I trial, an intranasal adjuvanted recombinant influenza vaccine appeared to result in response to a range of H5N1 clades.
    • “The adjuvanted vaccine elicited seroconversion against clade 2 subclades, including the avian influenza H5N1 clade.
    • “Post-dose reactogenicity symptoms to the adjuvanted vaccine were common and mostly mild.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente and its subsidiaries posted a $218 million operating income, or a 0.7% operating margin, for the third quarter of 2025, the country’s largest nonprofit health system shared Friday in a release.
    • “The integrated care organization painted its operating performance as below average for nonprofit healthcare entities. Still, the tally is still well ahead of its $608 million operating loss (-2.1% operating margin) from the third quarter of 2024, when higher-than-expected utilization, pharmacy costs and other factors triggered a push to reduce spending.
    • “Kaiser also benefited from a strong financial market conditions that fueled a $2.4 billion nonoperating income for the quarter. This gave the organization a bottom-line net income of $2.6 billion, again much stronger than the prior year’s $845 million.
    • “Consolidated operating revenues for the quarter hit $31.8 billion, up about 99.7% year over year, while operating expenses hit $31.6 billion, a roughly 6.8% increase. Membership across Kaiser and its Risant Health affiliates was more than 13.1 million as of Sept. 30, roughly the same as when it closed its second quarter June 30.”
  • Beckers Payer Issues recounts that “health insurers spent the third quarter resetting pricing models and narrowing their product portfolios as medical cost trends remained elevated and Medicare Advantage headwinds intensified heading into 2026.”
  • Beckers Hospital Review points out,
    • “Twenty-seven labor and delivery units at rural hospitals have shuttered in 2025, up from 21 in 2024, according to a new report from the Center for Healthcare Quality and Payment Reform.
    • “The report found that since year-end 2020, 116 rural hospitals have ended deliveries or planned to do so by year-end 2025. Rural L&D units have closed in most states over the last five years, and in three states, at least one-quarter of rural hospitals with maternity services have ended deliveries. Only 41% of U.S. rural hospitals provide L&D services, with less than one-third offering them in 12 states. 
    • “The findings highlight a concerning trend, driven by limited alternative revenue streams or inadequate reimbursement, which suggests that more rural communities could be at risk of losing maternity care due to the financial uncertainties of offering the services.”
  • and
    • “Since June, Jacksonville, Fla.-based Nemours Children’s Health has cared for more than 120 children with complex medical conditions at home through a first-of-a-kind program.
    • “The Advanced Care at Home program is designed for children who are medically stable but require ongoing advanced care. It is the nation’s first at-home care model operated by a freestanding children’s hospital, according to a Nov. 10 news release from Nemours.
    • “Since its launch, the program has helped avoid 177 inpatient days, 27 hospital readmissions and 91 emergency department visits, Nemours said.” 
  • MedTech Dive notes,
    • “Laborie Medical Technologies has struck a deal to buy a post-childbirth medical device from Organon for $440 million upfront, the companies said Friday.
    • “The acquisition covers the Jada system, a treatment for abnormal postpartum uterine bleeding or hemorrhage, and around 100 employees who will transfer to Laborie as part of the deal.
    • “Organon acquired the system in 2021 for an initial $219 million. The women’s health specialist grew sales from $20 million in 2022 to $61 million in 2024 as more hospitals stocked the system.”

Weekend update

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

From the Washington, DC,

  • The Wall Street Journal reports,
    • “The Senate was driving toward a deal to end the record government shutdown, with the top Senate Republican saying to expect a vote as soon as Sunday but also warning that an unpredictable negotiation could still hit some snags.” * * *
    • “We’re close to the finish line,” said Sen. Catherine Cortez Masto (D., Nev.), a centrist who is one of three Democrats who have repeatedly voted to fund the government.
    • “The Senate Appropriations Committee released three full-year funding bills, covering veterans’ programs and the construction of military housing as well as the Agriculture Department and the legislative branch. An interim measure expected to temporarily fund the rest of the government still hadn’t been released, and Republicans didn’t specify how the main Democratic demand to extend expiring healthcare subsidies would be handled.
    • “Any deal would still need approval in the House of Representatives, which has been out of session since Sept. 19. House Speaker Mike Johnson (R., La.) has put members on notice that he would give them 48 hours to return in the event the Senate passed a spending bill.
    • “A key development that appeared to break the logjam in the negotiations was that Senate Republicans proposed that some healthcare funding be provided directly to households rather than be used to pay for a one-year extension of enhanced ACA subsidies.
    • “That GOP proposal involves sending federal money into flexible-spending accounts instead of to insurance companies that use the money to offset the cost of premiums, so consumers pay a smaller monthly bill. The money could be used to cover deductibles and other out-of-pocket costs, which Republicans see as a way to give consumers more choice and control healthcare inflation.”
  • The cloture resolution to the continuing resolution to end the shutdown passed by the minimum 60-40 vote last night. Roll Call explains,
    • “The vote had been held open for over two hours allow for Sen. John Cornyn, R-Texas, the 60th vote, to return to the Capitol. He’d been back home over the weekend officially filing as a candidate for re-election next year in his state’s Republican primary.”
    • Eight Democratic senators voted aye per the Wall Street Journal.
  • Roll Call adds,
    • “The new continuing resolution would extend current funding levels through Jan. 30, along with three full-year appropriations bills covering the Departments of Agriculture and Veterans Affairs as well as legislative operations. It also carries a host of “extender” provisions for authorizing committees that haven’t completed work on other bills, mostly through January, though there is a one-year farm bill extension.” * * *
    • “Senate Majority Leader John Thune, R-S.D., said the arrangement includes a commitment to vote on a Democratic-drafted extension of expanded health insurance subsidies by mid-December, ahead of their Dec. 31 expiration.
    • “Another key provision for Democrats who’d been on the fence would reverse mass layoffs announced by the Trump administration since the shutdown began Oct. 1, at least while the government remains open.”
  • The Senate needs to enact the continuing resolution which requires a majority vote and then the continuing resolution heads over to the House of Representatives again for a majority vote. The President must sign the continuing resolution to enact it. Because Tuesday is a federal holiday, the shutdown will continue into later this week.
  • There are no Congressional committee meetings scheduled for this week.
  • The Federal Benefits Open Season begins tomorrow. OPM notes
    • “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 8, 2025, for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) and Postal Service Health Benefits Program (PSHB) ends at 11:59 pm, per the location of your electronic enrollment system, on Monday December 8, 2025.”

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “Federal health officials are investigating a multistate outbreak of infant botulism linked to ByHeart baby formula, prompting the company to recall two batches of one of its products.
    • “Thirteen babies in 10 states have been hospitalized as a result of the outbreak, the Food and Drug Administration and Centers for Disease Control and Prevention said. No deaths have been reported.
    • “ByHeart recalled two batches — 206VABP/251261P2 and 206VABP/251131P2, both with a “Use by” date of Dec. 1 — of its Whole Nutrition Infant Formula, the FDA said in a statement Saturday. The code and date can be found on the bottom of the container, the agency said. The company said the recall was voluntary and “out of an abundance of caution.” * * *
    • “The 13 cases linked to ByHeart formula were reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. The ages of the affected children were from around 2 weeks to 5 months old, the CDC said.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Merck, the company that introduced statins to the world nearly 40 years ago, has a new, intensely powerful pill that can slash levels of dangerous LDL cholesterol to levels almost never seen in adults.
    • “The new pill, enlicitide, blocks a liver protein, PCSK9, that slows the body’s ability to clear cholesterol. With most PCSK9 blocked, LDL levels plummet and rates of heart attacks and strokes in high risk patients fall by up to 20 percent in just the first year.
    • “At least six million adults in the United States are eligible for drugs that block PCSK 9.
    • “Merck’s head of research said the goal is to make the pill affordable. It would be an alternative to expensive biweekly or monthly injections of monoclonal antibodies that do the same thing. But only around one percent of eligible patients take the injections, which include Praluent by Regeneron and Sanofi, and Repatha by Amgen. Many patients don’t want to inject themselves, and insurers put up obstacles to paying, cardiologists say. The drugs’ list prices are more than $500 a month.”
  • STAT News adds,
    • “A cholesterol-lowering injection that’s been on the market for nearly a decade has now shown its power to cut cardiovascular events in people considered at high risk but who haven’t yet suffered a heart attack or stroke.
    • “A study published Saturday in the New England Journal of Medicine and presented here at the American Heart Association’s scientific sessions concluded that Repatha reduced coronary heart disease death, heart attack, and stroke by 25% overall and lowered first heart attacks by 36% in people with high cholesterol but no history of these serious events. Their high cholesterol meant they were already taking statins or other cholesterol-lowering medications.
    • “Repatha, made by Amgen, also reduced cardiovascular problems and prevented the need for stent and bypass procedures, meeting both endpoints of the clinical trial called VESALIUS-CV. That’s better than statin therapy, an older class of cholesterol-lowering drugs that became the best-selling medicines in the world.” 
  • The Washington Post informs us,
    • “One of the largest studies ever conducted on the link between the shingles vaccine and brain health offers insight into how the disease increases dementia risk.
    • “People who experienced multiple episodes of shingles had a higher risk of dementia for several years after the second outbreak, the study found, compared with those who had it only once.
    • “The findings, published recently in the journal Nature Medicine, provide additional evidence for why getting vaccinated for shingles could help protect the brain.
    • “Shingles stems from the varicella-zoster virus, which causes childhood chickenpox and hibernates in the nervous system. As people age, the virus reactivates but often is “beaten back down by the immune system,” said Pascal Geldsetzer, a professor of medicine at Stanford University and one of the study’s authors. But sometimes, he said, “it reactivates fully” and then you get shingles’ telltale symptoms, the burning, tingling, painful blisters and rash.”
  • Per Medscape,
    • “Continuous glucose monitoring (CGM) may be appropriate and potentially beneficial for patients undergoing dialysis, especially those with diabetes, according to a prospective community-based cohort study.
    • “The findings, published in the Journal of the American Society of Nephrology, demonstrated that in maintenance dialysis, CGM frequently identified episodes of hyperglycemia and hypoglycemia that may not be clinically evident.
    • “The authors noted that while CGM provides detailed glycemic profiles, few studies have evaluated its use in patients with kidney failure, with most limited to small or selective cohorts. They sought to address this by designing a study that characterized the spectrum of glycemia and its determinants in a large, demographically diverse population of patients receiving maintenance dialysis.”

From the U.S. healthcare business front,

  • BioPharma Dive confirms,
    • “Metsera has abandoned a deal with Novo Nordisk in favor of a new acquisition offer from Pfizer, ending a high stakes fight between two large pharmaceutical companies over ownership of a coveted maker of obesity drugs. 
    • “Under terms of a deal announced late Friday, Pfizer will acquire Metsera for up to $86.25 per share, or more than $10 billion. Pfizer will pay $65.60 per share initially and could add up to $20.65 per share more in “contingent value right” payouts tied to specific milestones. 
    • “Metsera’s board has thrown its support behind the new deal, arguing Pfizer’s proposal is now in shareholders’ best interests both because of its “value and certainty of closing.” In doing so, it rejected an unusual two-step bid from Novo Nordisk that alarmed the Federal Trade Commission and includes “unacceptably high legal and regulatory risks” comparatively. 
    • “Novo, in a separate statement, said it won’t make another bid and believes its latest offer complies with antitrust laws. Its decision to drop out of contention is “consistent with its commitment to financial discipline and shareholder value,” Novo said.”  

Friday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) proposed extending expiring healthcare subsidies for one year as part of a measure to reopen the government, in a move aimed at breaking the monthlong logjam.
    • “Under Schumer’s plan, which he has shared with Senate Democrats, lawmakers would then establish a bipartisan commission to devise changes to the Affordable Care Act, which Republicans have demanded as they seek to rein in federal healthcare spending.
    • “After so many failed votes, it’s clear we need to try something different,” Schumer said. After he spoke, Sen. Tammy Baldwin (D., Wis.) and other Democrats who had rejected a Republican-backed bill to fund the government through Nov. 21 said they could support the approach.
    • “But Senate Republicans quickly rejected the idea and said the offer was a sign that Democrats were caving. GOP lawmakers stuck to their position that negotiations on the subsidies could only occur after Democrats vote to end the shutdown. Democrats had originally sought a permanent extension of the subsidies, at a 10-year cost of roughly $350 billion.”
  • The Senate considered S. 3012, Senator Ron Johnson’s (R WI) bill to pay federal employees during this and any future shutdown. The bill failed to reach the 60 votes required for cloture (53 i favor and 43 opposed). The Senate adjourned at 6:45 pm ET and will resume it floor business tomorro at noon ET.
  • Federal News Network interviews NARFE Staff Vice President John Hatton about the Federal Benefits Open Season which begins next Monday. These comments from Mr. Hatton caught the FEHBlog’s eye:
    • “Terry Gerton: I’m speaking with John Hatton. He’s staff vice president of the National Association of Active and Retired Federal Employees. John, let’s come back to the OPM plans. They made some changes to default plans for folks whose coverage is going away. What do people need to know if they’re looking at an automatic enrollment? How is that process going to play out and what if it doesn’t fit their needs?
    • “John Hatton: Yeah, anytime your plan is dropping out, you’re defaulted into a different plan. So you don’t totally lose coverage. You don’t have to make an affirmative choice. That’s a good positive thing. This year, the NALC plan is dropping out of the federal side of the program. They’re still on the postal side. So if you’re a postal employee or retiree, you can still retain it. But that’s a significant number of people. OPM made the choice to not default into the lowest cost nationwide plan without a high deductible and without an association membership fee. That’s what the regulation says. Then it has another sentence that says they reserved the right to designate an alternate plan for automatic enrollments. So this year, the lowest cost nationwide plan would be the GEHA Elevate plan, but instead, they have designated the GEHA High plan. So in the past, you would be automatically enrolled into a low-premium plan. In this case, you’re automatically enrolled into a high-premium plan. So particularly if you had a consumer option in NALC, for example, you’re going to see a huge spike in increases if you just defaulted in and you don’t make an alternative choice. So we really encourage people to choose. I mean, maybe the high premium plan with more coverage is the right choice for you, but you may want to look at some other alternative plan, even with those low deductibles that might be cheaper because there are options, even with really low deductible plans that have lower premiums and kind of the main big dogs in the program. So really critical that you look and choose what’s best for you.”
  • OPM Director Scott Kupor posted the latest entry in his Secrets of OPM blog. The post concerns change to OPM’s process for making automatic interim annuity payments to retiree applicants. The Director concludes
    • “About 75% of retiree applicants are currently receiving automatic interim pay. This is up from 30-40% under our old process, and our goal is for 100% of retiring federal workers to receive that interim payment within 30 days as they wait for their application to be processed. We do that by taking this measured risk. Questioning old habits, comparing downside risk to upside opportunity is a mindset we are developing at OPM. It’s part of how we modernize: not just with new technology, but with new thinking.
    • “We recently published a new FAQ for retirees that explains what we’re doing to improve the retirement process as we prepare for a surge in applications. And as of last month, retirees can now track their retirement via the Retirement Processing Times page on the OPM website. It’s one more way we’re putting transparency and service at the center of everything we do.
    • “Sometimes progress means changing how we think about risk. And if that means moving a little faster to get people what they’ve earned, then that’s a risk worth taking. No more fighting the last battle.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has announced a new recall for the Tandem Mobi Insulin Pump from California-based Tandem Diabetes Care. 
    • “The battery-operated Tandem Mobi Insulin Pump can provide users with long-acting basal insulin doses or short-acting bolus insulin doses. It delivers insulin from a disposable cartridge, through an infusion set and into the patient’s tissue.
    • “The recall was put in place due to a possible software malfunction that could interfere with the delivery of insulin. According to the FDA, if this failure occurs, it could result in patients developing hyperglycemia.
    • “Unlike many recalls, this is not a product removal. However, the FDA has still determined this is a Class I recall, which means there is a risk of serious injuries or even death if customers do not follow company recommendations. 
    • “This recall covers nearly 18,000 insulin pumps distributed throughout the United States. The devices do not need to be returned, but Tandem Diabetes Care is urging customers to update their pump software immediately. The newest version of the pump software is 7.9.0.2. Customers can use their Tandem Mobi Mobile App to confirm their software version and update it if necessary.”
  • BioPharma Dive lets us know,
    • “A study volunteer who’d received an experimental gene-editing treatment from Intellia Therapeutics in a Phase 3 trial has died, the company said in its Thursday earnings report. Intellia voluntarily paused dosing in that study as well as another late-stage trial in late October, when that patient was hospitalized due to a spike in liver enzyme and bilirubin levels. The Food and Drug Administration formally put the two studies on hold days later. Intellia is now suspending guidance for the program, nexiguran ziclumeran or nex-z, pending alignment with regulators. The incident “clearly” complicates the path forward for nex-z, “heightens the safety overhang” and puts Intellia’s broader transthyretin amyloidosis program “at risk,” wrote Leerink Partners analyst Mani Foroohar. Intellia shares, which have already lost about 40% of their worth in recent weeks, tumbled to less than $10 apiece early Friday.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Medicare is often seen as a universal safety net, a guarantee for older Americans that after decades of work — and having taxes withheld from their paychecks — the federal government will provide health insurance once they reach 65. But a new study found an increasing number of people are dying before they realize that promise.
    • “Premature deaths among 18-to-64-year-olds rose 27 percent, going from 243 to 309 deaths per 100,000 adults between 2012 and 2022, according to a study published Friday in JAMA Health Forum. Among Black adults, the study found the increase was about 10 percentage points higher compared to White adults.
    • “Medicare is often seen as a universal safety net, a guarantee for older Americans that after decades of work — and having taxes withheld from their paychecks — the federal government will provide health insurance once they reach 65. But a new study found an increasing number of people are dying before they realize that promise.
    • “Premature deaths among 18-to-64-year-olds rose 27 percent, going from 243 to 309 deaths per 100,000 adults between 2012 and 2022, according to a study published Friday in JAMA Health Forum. Among Black adults, the study found the increase was about 10 percentage points higher compared to White adults.”
    • Irene Papanicolas, a professor of health services, policy and practice at Brown University School of Public Health and lead author on the study, said it builds on two others she published earlier this year.
    • “One study found that preventable and treatable deaths — in which people younger than 75 whose deaths were driven by preventable conditions such as heart disease, substance-related deaths and chronic respiratory illness — increased in every U.S. state between 2009 and 2019. Meanwhile, such deaths are declining in 34 other high-income countries and increased in six, the study showed.”
    • “The other report, which was published in April in the New England Journal of Medicine, found that wealth generally confers health and longevity, with the richest Americans having about a 40 percent lower risk of death than the poorest. But those wealthy people in the United States still live shorter lives than Northern and Western Europeans who earn modest incomes or live in poverty, the study found.”
  • The AP relates,
    • “Doctor after doctor misdiagnosed or shrugged off Ruth Wilson’s rashes, swelling, fevers and severe pain for six years. She saved her life by begging for one more test in an emergency room about to send her home, again, without answers.
    • “That last-ditch test found the Massachusetts woman’s kidneys were failing. The culprit? Her immune system had been attacking her own body all that time and nobody caught it.
    • “I just wish there was a better way that patients could get that diagnosis without having to go through all of the pain and all of, like, the dismissiveness and the gaslighting,” she said.
    • “Wilson has lupus, nicknamed the disease of 1,000 faces for its variety of symptoms — and her journey offers a snapshot of the dark side of the immune system. Lupus is one of a rogues’ gallery of autoimmune diseases that affect as many as 50 million Americans and millions more worldwide – hard to treat, on the rise and one of medicine’s biggest mysteries.
    • “Now, building on discoveries from cancer research and the COVID-19 pandemic, scientists are decoding the biology behind these debilitating illnesses. They’re uncovering pathways that lead to different autoimmune diseases and connections between seemingly unrelated ones – in hopes of attacking the causes, not just the symptoms.
    • “While there’s still an enormous amount to learn, recent steps have some specialists daring to wonder if just maybe, ways to cure or prevent at least some of these diseases are getting closer.
    • “In dozens of clinical trials, scientists are harnessing some of patients’ own immune cells to wipe out wayward ones that fuel lupus and a growing list of other diseases. It’s called CAR-T therapy and early results with these “living drugs” are promising. The first lupus patient was treated in Germany in March 2021 and remains in drug-free remission, the researchers said last month.”
  • Per MedPage Today,
    • “Patients with plateaued weight loss or who reached their weight-related goals on a GLP-1 receptor agonist were able to maintain their improvements in weight, body composition, and metabolic improvements after they reduced the frequency of their dose, according to a recent case series. 
    • “Among 30 patients who reduced their dose frequency to anywhere between every 10 days to every 5-6 weeks, 26 of them remained at the weight they had reached before doing so, and some even lost another couple of pounds, Mitch Biermann, MD, PhD, from the Scripps Clinic Department of Internal Medicine and the Scripps Whittier Diabetes Institute in San Diego, reported at the ObesityWeek annual meeting.
    • “Patients also saw no subsequent worsening in blood glucose, lipids, blood pressure, or other metabolic measures, and some continued to improve. 
    • “My main conclusion is that, at least among patients that experience normalized metabolic syndrome parameters doing every week on these medications, if they are that type of successful patient, they’re likely to remain successful even if you reduce the frequency,” Biermann said. “The dose doesn’t have to be the maximum, and the frequency doesn’t even have to be every other week.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The long-acting monoclonal antibody nirsevimab (Beyfortus) protects children younger than 2 years from respiratory syncytial virus (RSV) infection for up to 1 year but may not do so beyond that period, suggests a large real-world study published yesterday in the Journal of Infection.
    • “The researchers, however, cautioned that the small sample size of children who received nirsevimab at least 12 months before may have limited the ability to detect significant results past 1 year.” * * *
    • “The findings have implications for scheduling repeat dosing in eligible children, the study authors said. “Currently, the second dose of nirsevimab for eligible children with high-risk comorbidities is often administered during the second season, with a minimum interval of 5–6 months,” they wrote. “In some regions, the RSV epidemic is year-round, where repeat dosing of nirsevimab at 5–6-month intervals can be costly.”
    • “The results need to be interpreted with caution owing to the inability to identify children whose mothers were vaccinated against RSV during pregnancy, potential missing documentation of nirsevimab administration, and residual confounding factors after propensity score matching. 
    • “The authors called for future studies on the long-term effectiveness of nirsevimab against RSV hospitalization, intensive care unit admission, and death.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “In a proof of concept that may reshape the treatment landscape for insulin-dependent diabetes, scientists have demonstrated that human stomach cells can be reprogrammed to secrete insulin—potentially paving the way for autologous cell-based therapies that eliminate the need for donor islets and systemic immunosuppression, as well as lifelong monitoring of blood sugar levels and insulin injections.
    • “The study, “Modeling in vivo induction of gastric insulin-secreting cells using transplanted human stomach organoids,” published in Stem Cell Reports and led by Xiaofeng Huang, PhD, of Weill Cornell Medicine and Qing Xia, MD, PhD, of Peking University, shows that human gastric tissue can be transformed in vivo into functional insulin-producing cells using a precision combination of defined genetic factors. The work builds on earlier findings in mice that the stomach’s cellular architecture can be coaxed into producing insulin and represents the first demonstration that this conversion can occur in human-derived tissues inside a living organism.”

From the U.S. healthcare business front,

  • The Wall Street Journal tells us about the founders of Metsera.
    • “Long before he found himself in the middle of a multibillion-dollar takeover battle for a coveted new weight-loss drug, Whit Bernard was a music nerd. He spent two years studying the role of musical activity in the nonviolent anti-Soviet uprisings of the Baltic States during the Perestroika era, publishing his research in English and Latvian. 
    • “After he got tired of working at a music nonprofit in Brooklyn, N.Y., he went to business school and became a consultant at McKinsey & Co. 
    • ‘His client was Clive Meanwell, a cancer researcher turned pharmaceutical executive who hired McKinsey to shore up costs and make other changes at his biotech Medicines Co. 
    • “The two hit it off, and Bernard left McKinsey to become Meanwell’s head of business development. They agreed to sell Medicines to Novartis for almost $10 billion in 2019, and looked to start another company. 
    • ‘Meanwell did what he does best—find the next big thing in medicine by looking for the biggest afflictions facing the most patients. Weight-loss drugs, he bet. Now, Bernard, 41, and Meanwell, 68, are about to pull off a big sale again. 
    • Pfizer PFE is locked in an unusually bitter fight to pay upward of $10 billion to buy Metsera MTSR and its stable of at least eight potential new drugs that can enter a global weight-loss market that analysts project will surpass $100 billion in 2030. 
    • The two stand to profit big from a transaction. Their firm Population Health Partners owns roughly 12% of Metsera shares, which would net it over $1 billion, assuming the final deal values Metsera at $10 billion or more.
  • Bloomberg adds,
    • “Pfizer Inc. has submitted a sweetened bid for obesity drug startup Metsera Inc. as its fight against rival Novo Nordisk A/S continues to escalate, according to people familiar with the matter.
    • “The new offer improves upon Pfizer’s earlier proposal for $86.20 a share including milestone payments, said the people, who asked not to be identified discussing private information. Pfizer’s revised bid on Friday is the latest in its back-and-forth with Novo, which submitted a proposal topping Pfizer’s for the second time on Thursday.
    • “Under the terms of its merger agreement, Pfizer will win even if the companies offer the same amount. The bidding war could continue with Novo increasing its offer, the people added.”
  • Per MedTech Dive,
    • “Synchron has raised $200 million to support commercialization of its brain computer interface platform, the company said Thursday.
    • “The Series D round will fund preparations to launch Synchron’s first-generation platform, which translates brain activity into digital commands without open-brain surgery, and development of a new interface.
    • “Synchron’s funding moves investment in BCI companies in 2024 and 2025 beyond $1 billion, with the round adding to financings at Blackrock Neurotech, Neuralink and Precision Neuroscience.”
  • Per Beckers Payer Issues,
    • “Baltimore-based Johns Hopkins is convening with health plans, health systems, policymakers and patients to further high-value care, according to a document shared with Becker’s on Nov. 7.
    • “The purpose of this convening proposal is to create sustainable improvements in healthcare value by aligning and synergizing the work of health systems, health plans and policymakers,” the grant application said. “We will bring together experts to collaboratively design meaningful metrics that increase quality, safety and value.” 
    • ‘The initiative, called Providers, Health Plans, Policymakers and Patients Aligned in Care Transformation, consists of three work groups. One will address hospital quality and process-based metrics, another will tackle ambulatory value-based care performance metrics and the third will focus on resource utilization management rules. Johns Hopkins Health Plan’s chief medical officer and associate chief medical officer are among the program’s leaders.”
  • Beckers Hospital Review offers a non-exhaustive list of “81 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 informs us,
    • “Nearly 7 in 10 healthcare consumers will leave a review when texted or emailed, meaning a “passive reputation management strategy won’t cut it” for health systems, according to a Press Ganey report published Nov. 6. 
    • “Referrals historically defined a health system’s reputation, but now, reviews do.
    • “Press Ganey, a healthcare experience consulting firm, analyzed 6.5 million patient encounters across the U.S. and surveyed 1,000 healthcare consumers, which are defined as adults who researched healthcare providers online in the past year.”

From the artificial intelligence front,

  • Beckers Hospital Review shares the 10 best quotes on AI from Becker’s CEO + CFO Roundtable.
  • TechTarget reports,
    • “Recent headlines have warned that AI will decimate jobs and reshape work as we know it. But a new study from Yale University’s Budget Lab, “Evaluating the Impact of AI on the Labor Market: Current State of Affairs,” suggests the reality is less dramatic, at least for now.
    • “The study, conducted in partnership with the Brookings Institution, examined nearly three years of labor market data, beginning with the mainstream launch of ChatGPT in late 2022.
    • “Despite the rapid progress of generative AI, researchers found no clear evidence that the U.S. workforce has undergone widespread displacement. Instead, the occupational mix has remained strikingly stable.
    • “Despite how quickly AI has advanced, the labor market story over the past three years has been one of continuity over change,” said the study’s co-author, Molly Kinder, while speaking to the Financial Times.”
       
  • McKinsey and Co. considers what clinical trials will look like in 2035.
    • “The biopharmaceutical industry stands at a critical juncture, where rapid scientific advancements and increasing competition demand a fresh look at clinical trial delivery. As the industry hurtles toward 2035, the need for a transformative vision has never been more pressing. This article outlines a bold new direction for clinical trials, one that aspires to double trial speed and patient participation while enhancing outcomes and reducing costs. By examining the key drivers of change and the essential elements of a next-generation clinical development engine, we could unlock a future in which clinical trials are more efficient, more accessible, and more patient-centered.”

Midweek update

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Tuesday Report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senators said they were increasingly optimistic that they could reach a bipartisan deal to end the government shutdown, while President Trump raised pressure on Republicans to bypass Democrats and end the near-record-setting impasse without their votes.
    • “Senate Majority Leader John Thune (R., S.D.) on Tuesday outlined a pathway forward, pointing to the possibility of combining a new short-term bill to reopen the government with some of the 12 annual appropriations bills that fund federal agencies. He said that the off-ramp was focused on giving Democrats a vote on an extension of expiring Affordable Care Act subsidies along with plans for the spending bills.
    • “I’ve said this before, but the question is whether or not they’ll take ‘yes’ for the answer,” Thune said.
    • “Several lawmakers said they thought the shutdown would come to a close by the end of the weekend if talks progressed.
    • “I think we’ve got a real shot,” Sen. John Hoeven (R., N.D.) said of the possibility of the shutdown ending soon.
    • “We’re continuing to talk.” said Sen. Gary Peters (D., Mich.). “We’re in a sensitive time right now.”
  • The Hill adds,
    • “A quartet of bipartisan House lawmakers on Monday proposed a framework to temporarily extend ObamaCare’s enhanced tax credits that includes a sunset period and an income cap for high earners. 
    • “The “statement of principles” from centrist Reps. Don Bacon (R-Neb.), Tom Suozzi (D-N.Y.), Jeff Hurd (R-Colo.) and Josh Gottheimer (D-N.J.) represents the only public proposal from either side to address the subsidies since the government shut down more than a month ago.” 
  • MedTech Dive tells us,
    • “The co-chairs of the House and Senate Diabetes Caucuses urged the Centers for Medicare and Medicaid Services not to finalize proposed changes that would affect how the agency pays for diabetes devices.
    • “In June, the CMS issued a proposed rule to include insulin pumps and continuous glucose monitors in a competitive bidding program. It would also change payments to a monthly rental rather than a contract where devices are paid for upfront. 
    • ‘In a letter sent to CMS Administrator Mehmet Oz in October, caucus leaders raised concerns that the changes would reduce and complicate access to CGMs and insulin pumps. Medtech lobbying group AdvaMed issued a statement on Monday also urging the CMS not to finalize the proposal.”
  • HealthLeaders Media informs us,
    • “The final 2026 CMS Physician Fee Schedule eliminates frequency limits on telehealth services inside hospitals and skilled nursing facilities and allows for remote supervision and training.
    • “However, CMS is eliminating a five-year-old policy that allowed providers to report and bill for remote services using their practice location, a move that could prompt doctors to avoid treating patients during nights and weekends.”
  • Kevin Moss, writing in Govexec, offers Open Season advice to federal and postal employees and annuitants.
  • Federal News Network interviews Thiago Glieger from RMG Advisors about OPM’s new retirement claims process system known as ORA.
  • The Wall Street Journal relates,
    • “The Trump administration is negotiating a deal with weight-loss drugmakers Eli Lilly LLY and Novo Nordisk NOVO.B that would allow the lowest doses of some of their obesity drugs to be sold to consumers at $149 for a month’s supply via TrumpRx, according to people familiar with the matter.
    • “The deals would also result in Medicare and Medicaid covering the drugs for weight loss, the people said, which would be a boon to the companies.
    • “The discussions are still ongoing but if agreements are finalized, Trump is expected to announce them Thursday morning at the White House, alongside pharmaceutical executives, the people said.”
  • This development would unlock tremendous savings for FEHB and PSHB plans which now must pay primary for these drugs when prescribed for obesity to Medicare prime annuitants. Following implementation, the FEHB and PSHB plans would pay secondary to Medicare for those folks.

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled lot of 20 mEq potassium chloride injection bags. The notice said the products are incorrectly labeled with a 10 mEq overwrap. The company said a potential overdose of potassium chloride is possible if an incorrect dosage is used, potentially leading to hyperkalemia. Otsuka ICU Medical said it has not yet received any reports of adverse events due to the issue.”
  • Per Fierce Pharma,
    • “UCB has scored an FDA approval for ultra-rare disease treatment Kygevvi, continuing the positive momentum for the Belgian company.
    • “The U.S. nod for Kygevvi—which is the third rare disease drug approval for the company in less than three years—is to treat the genetic mitochondrial disease thymidine kinase 2 deficiency (TK2d). It is the first targeted medicine for the muscle-weakening disorder. Kygevvi is cleared for adults and pediatric patients who have experienced symptom onset by age 12.
    • “When TK2d appears early in life, it increases the risk of rapid progression and death. It can be fatal within three years of symptoms emerging. TK2d strikes an estimated 1.64 in every 1 million people, affecting patients’ ability to walk, eat and breathe independently.”
  • Per MedTech Dive,
    • “Dexcom recalled an Android app for its G6 glucose sensor due to a software problem that could cause the app to terminate unexpectedly.
    • “The issue could cause users to miss alarms, alerts or notifications related to estimated glucose values, according to a Food and Drug Administration database entry posted Oct. 30.
    • “The glucose sensor and the app are still available, but Dexcom required users to update the app to a new version. 
    • “Dexcom began the recall on Aug. 28. The FDA designated the event as a Class 1 recall, the most serious kind.” 
  • The Washington Post reports,
    • “At least six people across the United States have become ill and died after eating prepared pasta meals linked to a growing listeria outbreak, federal health officials said.
    • “Fettuccine, linguine, farfalle and other pasta meals sold at major grocery stores including Albertsons, Kroger, Sprouts Farmers Market and Trader Joe’s have been recalled over the past few months.
    • “Supplier Nate’s Fine Foods expanded its recall in September after a pasta sample tested positive for Listeria monocytogenes, the Food and Drug Administration said. The company said it was working with health officials to investigate the source.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics intends to seek full U.S. clearance for a pair of Duchenne muscular dystrophy medicines even though the two treatments failed a study designed to confirm the benefits observed in earlier testing. 
    • “According to Sarepta, after 96 weeks of treatment, patients receiving the drugs, Vyondys 53 and Amondys 45, instead of a placebo didn’t achieve statistically significant benefits on the study’s main objective, a measure of how quickly they can climb four steps. Sarepta, however, said Monday that the nine-year study, called Essence, was compromised by the COVID-19 pandemic and that the medicines demonstrated “consistent clinically favorable trends.” 
    • “On a conference call with analysts, Sarepta CEO Doug Ingram said the company intends to meet with the agency to discuss converting the accelerated approvals for Vyondys 53 and Amondys 45 into traditional clearances. Despite the study’s failure, “we believe we have a good argument,” he said, noting the “totality of the evidence” generated to date, which includes years of testing and real-world use.”

From the public health and medical / Rx research front,

  • Beckers Hospital Review explains “why delayed care is taking on new urgency for health systems.”
    • “While delayed care remains a top concern for hospital leaders, their strategies also reflect broader shifts toward prevention and long-term health outcomes.
    • “Mr. Robinson was promoted to president of Arkansas Heart Hospital in October after serving as the hospital’s chief strategy and operations officer. He said one of his priorities is a more expansive focus on health outcomes, rather than internal operations.
    • “It’s a mindset shift. It’s the age-old adage: healthcare versus sick care. We do a really good job of offering sick care, but we call it healthcare. I think there are some incredible things we do in sick care,” he said. “But there’s great value in offering true healthcare, which is more prevention- and education-based.”
    • “He specifically pointed to AHH’s intensive cardiac rehab program, which is designed to help prevent a second cardiac event through supervised exercise, nutrition education and lifestyle coaching. The overall goal of the program is to improve long-term outcomes.
    • “In my mind, that’s excellent care,” Mr. Robinson said. “But what if, instead of just rehabilitation, we had ‘prehabilitation’ — going into communities with supervised exercise, nutrition, education and coaching to prevent the first cardiac event?
    • “That’s where my mind goes with this role change [to president]: How do we partner with communities, rural hospitals and local clinics? How do we increase education, screening and opportunities to prevent cardiovascular disease before it starts?”
  • Beckers Clinical Leadership points out,
    • “A surgical team at New York City-based NYU Langone Health has performed the first pig-to-human kidney transplant as part of a new clinical trial for patients with end-stage renal disease.
    • “The multisite Expand study is the first U.S. clinical trial to evaluate the safety and efficacy of a genetically engineered pig kidney. The organ, developed by United Therapeutics Corp., features 10 gene edits — six human genes added to improve immune compatibility, and four porcine genes inactivated to reduce rejection risk and control growth.
    • “Participants will be monitored for 24 weeks after transplant, with lifetime follow-up to assess kidney function and screen for zoonotic infections.
    • ‘While other pig kidney transplants have been performed in the U.S. under the FDA’s Expanded Access pathway, the Expand study is the first to proceed under a formal clinical trial framework intended to support regulatory approval. One such Expanded Access program is underway at Mass General Brigham in Somerville, Mass., using organs developed by eGenesis.”
  • Healio adds,
    • “National implementation of a race-neutral eGFR equation contributed to more modifications and higher kidney transplantation rates for Black candidates, according to study data published in the Journal of the American Society of Nephrology.
    • “Before 2023, a race-inclusive equation was used in determining kidney transplant prioritization. According to Jesse D. Schold, PhD, MStat, MEd, professor of surgery and associate vice chair of policy and outcome at the University of Colorado Anschutz Medical Campus, this equation perpetuated disparities in wait times, notably for Black candidates.”
  • MedPage Today notes,
    • “After an increase in colorectal cancer among patients younger than 50, U.S. guidelines started recommending that screening begin at age 45 for average-risk adults.
    • “This study showed that facility-based colorectal cancer screening rates among adults ages 45 to 49 increased about 10-fold following guideline changes.
    • ‘Among over 7 million screenings, the proportion involving individuals ages 45 to 49 increased from 2.9% in the period before the guideline changes to 17.8% after the changes.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “By stimulating cancer cells to produce and release an enzyme that activates the cGAS-STING signaling pathway in nearby immune cells, MIT researchers found a way to force tumors to trigger their own destruction.
    • “The researchers used lipid nanoparticles (LNPs) to deliver cyclic GMP-AMP (cGAMP) synthase (cGAS) mRNA to cancer cells. This results in production of the endogenous stimulator of interferon genes (STING) agonist cGAMP, which is then released and transferred to neighboring immune cells. STING is a protein that helps to trigger immune responses.” * * *
    • “[MIT researcher Natalie] Artzi [Ph.D.] is senior author of the team’s published paper in Proceedings of the National Academy of Sciences(PNAS), titled “Restoration of cGAS in cancer cells promotes antitumor immunity via transfer of cancer cell–generated cGAMP,” in which they concluded “These findings highlight how cancer cells can be used to actively contribute to their own elimination and may be a broadly applicable strategy for delivery of other reprogramming molecules to cancer cells and wider therapeutic combinations.” Alexander Cryer, PhD, a visiting scholar at IMES, is the study’s first author.”
  • Per Neurology Advisor,
    • “Combination therapies that integrate pharmacologic and nonpharmacologic interventions produce the greatest improvements in cognition, behavior, and daily functioning among adults with Alzheimer disease, outperforming either approach alone.”
  • Surprisingly, at least to the FEHBlog, Health Day tells us,
    • “Women are gritting out menopause without seeking any treatment for their symptoms, a new Mayo Clinic study says.
    • “More than 4 out of 5 women said they did not seek medical care for menopause symptoms, researchers reported in Mayo Clinic Proceedings.
    • “Menopause is universal for women at midlife, the symptoms are common and disruptive, and yet, few women are receiving care that could help them,” said lead researcher Dr. Ekta Kapoor, an endocrinologist and menopause specialist at the Mayo Clinic in Rochester, Minnesota.
    • “This gap has real consequences for women’s health and quality of life, and it’s time we address it more proactively,” Kapoor said in a news release.”

From the U.S. healthcare business front,

  • Fierce Pharma discusses Pfizer’s November 4 earnings announcement, while BioPharma Dive delves into Vertex’s latest earnings announcement.
  • CNBC reports,
    • “The blockbuster weight loss drug market is entering a new chapter of growth.
    • “Eli Lilly and Novo Nordisk are both focused on fighting for market share, ramping up supply, testing new uses for their medicines and bringing the next wave of obesity drugs to patients.
    • “Trailing behind them is a slate of drugmakers racing to win a slice of what some analysts expect could be a roughly $100 billion market by the end of the decade.
    • “But questions remain about insurance coverage, drug pricing, copycat treatments and the role of pills.”
  • The Wall Street Journal adds,
    • “Drugmakers Novo Nordisk NOVO.B and Pfizer PFE raised their offers in the multibillion-dollar takeover battle for obesity-drug developer Metsera MTSR, the latest twist in their unusual fight over the startup.
    • “Metsera said Tuesday that Novo Nordisk’s proposal values the biotech company at up to $86.20 a share, or approximately $10 billion, up from its previous bid of $9 billion. This valuation represents an approximately 159% premium to Metsera’s closing price on Sept. 19, the last trading day before the Pfizer deal was disclosed.
    • “Pfizer’s new offer values Metsera at up to $70 a share, or about $8.1 billion. Pfizer had previously struck a deal to buy Metsera for up to $7.3 billion.
    • “It is rare for companies to reopen bidding after a deal has been reached. The duel between two of the world’s biggest drugmakers over a 3-year-old company with just over 100 employees and no approved drugs shows the importance of weight-loss drugs to the pharmaceutical industry.” * * *
    • “The Danish company’s effort to snatch away Metsera has touched off a legal battle with Pfizer. On Friday, Pfizer sued Metsera in Delaware Chancery Court, seeking to block the startup from terminating its September merger agreement with Pfizer.
    • Metsera said Pfizer was improperly asking the court to intervene in what should be a standard bidding process. 
    • “The Court should refuse Pfizer’s attempt to wipe out Novo’s superior topping bid, especially in a live auction where further increased bids may come from Pfizer itself if this Court rejects its proposed” restraining order, Metsera wrote in a document filed Monday in Delaware Chancery Court.
    • “Pfizer filed a second lawsuit on Monday against Metsera and Novo Nordisk in federal court, alleging the weight-loss drug developers’ recent merger agreement would violate federal antitrust laws.” 
  • Fierce Healthcare reports,
    • “Hims & Hers stock jumped 6% in post-market trading Monday after the company said it was in active discussions to make Wegovy injections and Novo Nordisk’s forthcoming obesity pill available through the company’s online platform.
    • “Novo Nordisk expects to launch an oral obesity drug in the U.S. next year, once the Food and Drug Administration approves it.
    • “Hims & Hers said in a statement in its third-quarter financial results that “discussions are ongoing, no definitive agreement has been executed with Novo Nordisk, and there is a possibility that no definitive agreement may ever be executed with Novo Nordisk.”
  • STAT News adds,
    • “Noom, Found, and Hims & Hers have all launched programs to prescribe “microdosed” GLP-1s in the last three months, following in the footsteps of many smaller direct-to-consumer telehealth companies. Microdosing is getting a shot of promotion from Hollywood, too: Noom has promoted its program alongside a new celebrity spokesperson, actor Rebel Wilson, and TV host Andy Cohen has been doing the rounds talking about his microdosing habit. 
    • “In their marketing, telehealth companies claim that compounded GLP-1s in small doses — starting lower than FDA-approved doses from Novo Nordisk and Eli Lilly — can reduce metabolic risk, lower inflammatory markers, and even lower the risk of cognitive decline.
    • “Physicians and researchers say there is no robust clinical evidence that semaglutide or tirzepatide are effective at very small doses, and the drugs aren’t proven to help patients with many marketed symptoms. “Essentially these patients are guinea pigs, both on the efficacy side and the safety side,” said Reshma Ramachandran, a health services researcher and clinician at the Yale School of Medicine.”
  • and
    • “A spinout from the lab of Nobel laureate Jennifer Doudna has raised $82 million to create drugs that, with a single infusion, can turn patients’ immune cells into cancer- and autoimmune disease-fighting drones.
    • “It’s the latest entrant in a high-stakes race to develop what’s known scientifically as in vivo CAR-T treatments. Today’s CAR-T therapies are highly effective at treating certain blood cancers, but patients’ cells have to be removed, reengineered in a facility, and then reinfused — a toxic, expensive, and cumbersome process. Investors and pharma companies are spending billions to create alternatives that transform patients’ cells in their body.
    • “The company, known as Azalea Therapeutics, quietly raised a $17 million seed round in 2023 and then closed $65 million in new Series A last week. It’s a notable raise amid a protracted downturn for gene-editing startups. The last startup to emerge from Doudna’s lab, where CRISPR was first pioneered, was Scribe Therapeutics in 2020. Scribe last raised money from venture capitalists in 2021 and was forced to cut costs and lay off 20% of its staff at the start of this year.”


       

Monday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

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

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.”