Thursday report

Medical / Rx research

Thursday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Majority Leader John Thune (R., S.D.) told Senate Republicans Thursday that they should expect to vote on a new proposal Friday aiming to end the government shutdown, according to people familiar with the plan, indicating potential progress in resolving the monthlong impasse. 
    • “The proposal would combine a short-term spending measure with a package of three full-year funding bills, covering the legislative branch, agriculture, and military construction and veterans’ affairs. It was unclear whether the interim measure would keep the government open through mid-December or for a longer period. How Affordable Care Act subsidies, a central concern of Democrats, would figure into the plan also remained in flux. 
    • “The plan to vote on the revised proposal comes as the impact of the shutdown continues to grow. Government workers have gone without pay for weeks, and low-income families are seeing cuts in food aid and other assistance programs. On Thursday, airlines scrambled to review flight plans after federal officials revealed plans to reduce commercial air traffic starting Friday in response to the government shutdown.”
  • It is encouraging to see that the Senate will remain in session this week beyond today.
  • The Journal further reports,
    • “Airlines and travelers scrambled to review flight plans after U.S. transportation officials said they would throttle commercial air traffic starting Friday in response to the government shutdown.
    • “Transportation Secretary Sean Duffy said that traffic at 40 major airports would be reduced by as much as 10% as a safety measure. Air-traffic controllers and airport security agents aren’t being paid in the shutdown, which federal officials said has led to stretched staffing, flight delays and long security lines.
    • “The Federal Aviation Administration will start with a roughly 4% cut in flights this weekend at select airports, according to a Southwest Airlines internal memo reviewed by The Wall Street Journal. Some of the nation’s busiest airports are among those the FAA targeted for flight capacity cuts, including those in Atlanta, Chicago and New York.
    • “To put that in perspective, a 4% reduction in key markets represents approximately 100 flights, a level we routinely manage during standard weather or irregular operational events,” the memo said.”
  • and
    • “A federal judge has ordered the Trump administration to fully fund food-assistance benefits for November by Friday, criticizing the government’s efforts so far to make payments during the government shutdown. 
    • “Judge John McConnell said the administration violated the order he issued last weekthat required the government to tap emergency funds and “expeditiously” pay benefits under the Supplemental Nutrition Assistance Program, or SNAP.” * * *
    • “McConnell chided the government during a hearing on Thursday for its actions. “People have gone without for too long, not making payments to them for even another day is simply unacceptable,” said the judge, an Obama appointee.  
    • “He directed officials to release the full funding to states for November benefits by Friday. SNAP benefits, which cover roughly 42 million Americans, typically total about $8 billion a month. Since the contingency fund wouldn’t cover the full amount, he ordered them to use another source of money to make up the shortfall.” 
  • Tammy Flanagan, writing in Govexec, delves into OPM Director Scott Kupor’s blog entries about modernizing the federal retirement system.
  • Moving onto healthcare, BioPharma Dive relates,
    • “Novo Nordisk and Eli Lilly will sell their GLP-1 drugs for obesity and diabetes to some Medicare enrollees for $245 a month under an agreement hammered out with the Trump administration, the White House announced Thursday.
    • “Through the deal, the two companies will also offer some of the same drugs through an online government portal for about $350 a month. Lilly and Novo will additionally be required to sell starter doses of their coming oral obesity medicines, if approved by regulators, for $149 a month. They’ll have to offer all their weight loss drugs to state Medicaid programs at “most favored nation” prices, too.
    • “The new figures represent discounts to the list prices of Wegovy and Zepbound, which are $1,350 and $1,080 a month, respectively, as well as the $499 monthly charge on Lilly and Novo’s direct-to-consumer sites. But comparisons are different when weighed against the “net” prices that follow negotiations with insurers.” * * *
    • “[T]he Medicare price for GLP-1 drugs will be offered through a pilot program that will cover most beneficiaries, Novo said in a separate press release. That may be necessary, as the law that authorized Medicare coverage of prescription drugs specifically bars weight loss products. But it also likely limits which Medicare beneficiaries will qualify, and could have a fixed expiration date. Those that do benefit will have a $50 monthly copay.
    • “The agreement also won’t apply to the vast majority of people who receive their medications through commercial insurance.”
  • Fierce Pharma adds,
    • “The Trump administration is rolling out a new model that aims to bring most-favored nation pricing to the Medicaid space.
    • ‘The Centers for Medicare & Medicaid Services announced late Thursday the launch of the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) model, under which participating state Medicaid programs will be able to purchase certain drugs at prices that align with what is paid in other countries.
    • “The agency said the model, which launches in 2026, is designed around “allowing Americans to benefit from fairer, more competitive pricing.”
    • ‘CMS said that total gross spending in Medicaid on drugs in 2024 was $100 billion, up by $10 billion from 2022. Through the model, CMS will negotiate with participating pharmaceutical companies to bring down prices, while states that sign on will be able to implement coverage criteria that is uniform and transparent.”
  • The American Hospital Association News informs us,
    • “All 50 states have applied for the Rural Health Transformation Program, the Centers for Medicare & Medicaid Services announced Nov. 5. The program will fund $50 billion to states from fiscal year 2026 to FY 2030. Half of the funds will be awarded as baseline funding, and the other half will be distributed following a data-driven review that will assess each state’s initiatives and their alignment with the program. CMS said it would announce the recipients by Dec. 31.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. This second cohort brings the total number of voucher recipients to 15, underscoring the agency’s commitment to accelerating the review of products with the potential to address key national priorities.” * * *
    • “The following products were selected following external applications and internal nominations from FDA review divisions:
      • Zongertinib for HER2 lung cancer
      • Bedaquiline for drug-resistant tuberculosis in young children
      • Dostarlimab for rectal cancer
      • Casgevy for sickle cell disease
      • Orforglipron for obesity and related health conditions  
      • Wegovy for obesity and related health conditions
  • HCP Live tells us,
    • “The US Food and Drug Administration (FDA) has approved Ironwood Pharmaceuticals’ linaclotide (Linzess) capsules for pediatric patients ≥ 7 years of age with irritable bowel syndrome with constipation (IBS-C), making it the first treatment approved for IBS-C in this patient population.
    • “The drug works by increasing intestinal fluid secretion and reducing pain-sensing nerve activity.
    • “Approval was based on adult data and a pediatric trial showing significant symptom improvement.
    • “Safety profiles were consistent across age groups, with diarrhea as the most common side effect.
    • “Linaclotide is contraindicated in children under 2 due to dehydration risks.”
  • Per BioPharma Dive,
    • “Johnson & Johnson won Food and Drug Administration approval to sell its drug Caplyta for patients suffering from major depressive disorder, a key step in its ambitions to make the medicine a $5 billion-a-year seller.
    • “Caplyta is already cleared to treat patients with schizophrenia and those suffering from bipolar I and II depression, conditions that affect some 13 million Americans combined. Major depressive disorder, also known as clinical depression, afflicts about 22 million Americans and two-thirds of that group don’t get enough relief from current medicines, J&J said Thursday.
    • ‘The latest FDA approval is based on research that showed Caplyta could significantly improve depression symptoms, as well as an open-label study that found that 80% of patients responded to treatment, with 65% achieving remission. At the same time, the drug didn’t cause the side effects such as low sexual desire or weight gain that often leads patients to drop off antidepressant treatments, J&J said.”
  • MedPage Today lets us know,
    • “The FDA sent 18 warning letters to websites that illegally market unapproved and misbranded botulinum toxin (Botox) products, the agency announced.
    • “The letters were addressed to sites with names like cosmo-korea.com, derma-solution.com, glamderma.com, and koreanfillers.com, among several others.” * * *
    • “The sites were reportedly based in South Korea, China, Panama, and the U.S., according to the letters.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Heavy drinking is tied to earlier and more severe brain bleeds, a new study found. The paper, published Wednesday in the journal Neurology, examined the link between alcohol and intracerebral hemorrhages — the deadliest, most disabling type of stroke.
    • “The researchers found that so-called heavy drinkers — people who had three or more drinks per day — developed a stroke on average 11 years earlier than those who had fewer than three drinks per day. They also had larger brain bleeds that were more difficult to manage.
    • “This data cannot prove that alcohol led to earlier, more severe brain bleeds. But it aligns with a wide body of research linking heavy alcohol use to damaged blood vessels and cardiovascular disease.
    • “Alcohol in high doses is toxic to brain cells,” said Dr. Bruce Ovbiagele, a professor of neurology at the University of California, San Francisco, who was not involved with the study.”
  • and
    • “Radiation has long played a role in the treatment of breast cancer, though doctors have used it more sparingly in early-stage disease in recent years, as advances in diagnostics and treatment have improved survival rates.
    • “Now a new study with an unusually long follow-up period has found that radiation to the chest wall made absolutely no difference in survival among women with early-stage breast cancer who had been treated with mastectomy, lymph-node surgery and advanced anti-cancer drugs.
    • “The results of the large, randomized clinical trial were published on Wednesday in The New England Journal of Medicine.”
  • MedPage Today points out,
    • “Observational data point to a relationship between the vascular system and epilepsy beyond the brain.
    • “Among people ages 40 and older, heart attack survivors had a disproportionately greater risk of incident late-onset epilepsy.
    • “Late-onset epilepsy may also be a marker of systemic vascular disease.”
  • Infectious Disease Advisor adds,
    • “Although the second dose of the inactivated influenza vaccine (IIV) significantly increases protection relative to a single dose among children younger than 3 years, this benefit is not observed when the study population is broadened to include children younger than 9 years, according to study findings published in JAMA Network Open.”
  • Per Healio,
    • “A multidisciplinary comprehensive obesity care model increased GLP-1 persistence at 1 year.
    • “Patients in the program also had clinically meaningful weight loss outcomes and lower fat-free mass loss.”
  • Cardiovascular Business notes,
    • “Researchers are working on a new stem cell patch designed to help patients recover after a heart attack. The patch is implanted through a tiny incision, making open-heart surgery unnecessary, and then held in place with a biocompatible adhesive. It then helps the heart recover over time, replacing dead tissue that would typically never be able to regenerate. 
    • “The group behind this new technology presented its latest findings in Acta Biomaterialia.
    • “For patients with severe heart failure, there are very few options beyond mechanical pumps or transplants,” senior author Wugiang Zhu, PhD, a researcher with Mayo Clinic in Arizona, said in a statement. “We hope this approach will offer a new way to repair their own hearts.”
    • “Zhu et al. tested their new patch on rats that were given surgically induced heart attacks. The early findings suggest this approach could provide significant value to heart patients everywhere if it can be fine-tuned and tested on human subjects. Researchers noted that the patch improved heart function and reduced both scarring and inflammation.” * * *
    • “Click here to read the full analysis.” 
  • Beckers Clinical Leadership identifies the 10 hospitals with the lowest number of birth complications and the 10 hospitals with the highest number of those complications.

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “Eighty-eight percent of Americans are content with their health coverage, yet nearly half rate the country’s overall system a “C” or worse, according to a Nov. 6 survey from health insurance marketplace eHealth.
    • ‘The survey collected input from 1,524 adults across the U.S.
    • “This new survey highlights the mixed feelings many Americans have about our health insurance system,” Whitney Stidom, vice president of consumer enablement at eHealth, told Becker’s. “While many people are satisfied with their coverage, out-of-pocket costs are often a burden, and navigating the various coverage options can be challenging for some. It is crucial consumers understand their health insurance options, as doing so can help them save time, potentially reduce costs and encourage access to quality care.”
  • The Wall Street Journal reports,
    • Pfizer PFE is preparing to sweeten its offer again for Metsera, the weight-loss drug startup at the center of a bidding war that also involves Novo Nordisk. 
    • New York-based Pfizer is making plans to deliver a fresh bid Wednesday, according to people familiar with the matter, ahead of a deadline it has to respond to Novo Nordisk’s latest proposal. 
    • Under the terms of its existing merger agreement with Metsera, Pfizer’s next likely step is to match Novo Nordisk’s offer, one of the people said. 
    • Metsera shares closed Wednesday at $71.38 and rose over 7% after-hours after The Wall Street Journal reported on Pfizer’s plans. Novo Nordisk’s offer valued the company at $86.20 a share, while Pfizer’s most recent offer valued it at $70 a share, Metsera said.
  • Per STAT News,
    • “In its latest bid to shake up the prescription drug market, the Mark Cuban Cost Plus Drug Company has reached a deal to sell a cheap, biosimilar version of Stelara, a widely prescribed treatment for chronic inflammatory and autoimmune conditions.
    • “The company plans to sell the lower-cost medication for $345 every three months, or $1,380 a year, for a 90-milligram dose, before shipping costs. This is significantly below the list price for the brand-name drug sold by Johnson & Johnson, which can vary depending on patient weight and the specific illness being treated.”
  • Per BioPharma Dive,
    • “AstraZeneca has exercised an option to acquire SixPeaks Bio, an obesity drug startup that it helped launch last year with Versant Ventures.
    • “AstraZeneca revealed the deal in its latest quarterly earnings report on Wednesday. According to that report, the British drugmaker on Oct. 22 paid $170 million for the shares in SixPeaks it didn’t already own. AstraZeneca will add another $30 million to the deal in two years and could shell out a further $100 million based on the achievement of certain regulatory milestones. 
    • “SixPeaks launched in 2024 with $30 million in funding and a collaboration that gave AstraZeneca the chance to acquire it at an agreed-upon price.” 
  • and
    • “Moderna again reported declining vaccine sales and tempered its 2025 revenue outlook, but expressed confidence in its plan to break even financially in a few years.
    • “In third-quarter earnings on Thursday, Moderna reported $1 billion in revenue, down roughly 45% from the same three-month period a year ago. The company also lowered the top end of its projected revenue forecast for 2025. It now expects between $1.6 and $2 billion, down from an expected range of $1.5 billion to $2.2 billion.
    • “Still, Moderna shares, which have lost more than half of their value over the last year, ticked up as much as 5% in early trading Thursday. One reason why is progress the company has made in cutting costs, with Moderna claiming that, so far, it’s ahead of its projected target for the year. 
    • “We give credit where it’s due, and [Moderna] is clearly making progress on cost control,” Leerink analyst Mani Foroohar wrote in a note to clients Thursday.” 
  • Modern Healthcare reports,
    • “Cambia Health Solutions plans to bring another Blue Cross Blue Shield insurer under its umbrella as it seeks to scale its technology and care management services. 
    • “The nonprofit, which operates Regence Blue Cross plans in Idaho, Oregon, Utah and Washington, announced Thursday that it plans to join forces with Arkansas Blue Cross and Blue Shield. The proposed strategic affiliation is Cambia’s second this year; in August, the company proposed a similar partnership with Blue Cross Blue Shield of North Dakota.
    • “By affiliating, the Blue Cross companies aim to pool their investments and administrative capabilities to develop new technology and care management services, Cambia President and CEO Jared Short said. Partnering could boost each organization’s struggling finances, although that is not the primary driver of the planned affiliations, he said.” 
  • Healthcare Dive informs us,
    • “Dr. Amy Flaster joined Cigna late last year as the CMO of the Connecticut-based company’s health insurance arm. But now, she’s stepping into an expanded role as CMO of the entire business, encompassing both Cigna Healthcare and health services division Evernorth.
    • “Starting Nov. 1, Flaster is leading Cigna’s efforts to improve clinical performance, including testing and introducing new care models, overseeing providers and determining where technology could be an asset.
    • “At Cigna, Flaster will report to COO Brian Evanko.
    • “Her appointment coincides with the departure of Dr. David Brailer, a longtime healthcare executive who served as Cigna’s chief health officer since 2022.” * * *
    • “Cigna also announced that Katya Andresen, Cigna’s chief digital and analytics officer, will oversee the company’s “excellence and transformation” efforts, which shapes customer engagement.”
  • Per MedTech Dive,
    • “Diabetes tech nonprofit Tidepool will collaborate with Ōura to launch a partnership for diabetes research, the companies announced Tuesday.
    • “With users’ consent, Tidepool will pair biometric data from the Oura Ring with data from diabetes devices, including continuous glucose monitors and insulin pumps.
    • “The companies plan to start recruitment in early 2026 through a study approved by an institutional review board. Participants who opt into the study will share their data with Tidepool’s Big Data Donation Project. With users’ consent, the de-identified data will be shared with academics, researchers and industry to accelerate diabetes research.”

From the artificial intelligence front,

  • Beckers Health IT reports,
    • “Rochester, Minn.-based Mayo Clinic has introduced a program to help other health systems adopt AI.
    • ‘Mayo Clinic Platform_Insights provides a “guided, affordable path” for healthcare organizations of all sizes to keep up with advances in the technology, the health system said.
    • “Digital solutions and artificial intelligence have enormous potential to transform healthcare but there are barriers to widespread adoption,” stated Maneesh Goyal, COO of Mayo Clinic Platform, the health system’s digital innovation arm, in a Nov. 3 news release. “When organizations partner with us, they gain access to proven clinical and administrative solutions and the technical framework to integrate them seamlessly.”

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.”

Weekend update

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

From Washington DC

  • The Wall Street Journal reports
    • “Democratic senators again urged President Trump to get involved directly in talks to end the government shutdown as the impasse entered a crucial week, with the lapse set to become the longest ever while pain for American households and travelers is deepening. 
    • “Lawmakers indicated late last week that they were finally making progress on talks to reopen the government and begin discussions about how to address expiring enhanced Affordable Care Act subsidies, which are set to leave millions of Americans with sharply higher health-insurance bills. Democrats, who have repeatedly blocked a GOP measure to reopen the government, have made talks on healthcare a condition of voting to end the shutdown.
    • “Some travelers experienced abnormally long delays Sunday as a result of staffing shortages at major airports. Flights into Newark Liberty International Airport were delayed over three hours on average, according to Federal Aviation Administration data. People flying out of Houston’s George Bush Intercontinental Airport were warned that wait times could exceed 90 minutes.”
  • The Journal also offers advice to folks who are in the market for an Affordable Care Act plan during this open enrollment period.
  • Modern Healthcare explains,
    • “Doctors who treat Medicare beneficiaries are getting a 2.5% raise next year under a regulation the Centers for Medicare and Medicaid Services issued Friday.
    • “The 2026 Medicare Physician Fee Schedule final rule implements provisions from the tax law President Donald Trump enacted in July, which mandated a pay hike and reversed a multiyear trend of reimbursement cuts. CMS also spells out its plans for an “efficiency adjuster” that will reduce some payments, a lower back pain and heart failure payment model, and new flexibilities for telehealth coverage.
    • “The actions we are taking will improve seniors’ access to high-quality, preventive care that will help them to live longer, healthier lives,” CMS Administrator Dr. Mehmet Oz said in a news release. 
  • STAT News adds,
    • “Medicare on Friday followed through with its earlier proposal to reduce payment for surgeries, outpatient procedures, and other services it believes can be done more efficiently starting in 2026.
    • “The controversial move represents a significant change to how thousands of physician services are priced under Medicare. It’s a blow to the powerful physician lobby that has long controlled how procedures are priced and could help ensure more equitable pay among specialists and primary care doctors. 
    • “The so-called efficiency adjustment assumes that advances in technology and standardized workflows have cut down the time and expense necessary to perform certain procedures —  changes that reimbursement hadn’t accounted for. Those services will see a 2.5% cut to reimbursement beginning Jan. 1, 2026, while time-based services like office visits or behavioral health therapy will not. Telehealth and certain maternity services will also be unaffected.” * * *
    • “In response to comments on the proposal, Medicare will not apply the efficiency adjustment to payment codes that are new for 2026.” 

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “A Food and Drug Administration official who resigned on Sunday was sued by a Canadian pharmaceutical company, which accused him of soliciting a bribe and tanking its stock with false statements as part of a revenge campaign against a former colleague.
    • “Dr. George Tidmarsh was hired in July by FDA Commissioner Dr. Marty Makary to lead the agency’s drug division, a top role regulating much of the country’s pharmaceutical industry that gave Tidmarsh a prominent perch in the Department of Health and Human Services headed by Robert F. Kennedy Jr.
    • “Drugmaker Aurinia Pharmaceuticals filed a lawsuit in federal court in Maryland Sunday evening detailing its accusations against an official at an agency that this year has faced upheaval and uncertainty in the form of DOGE cuts, leadership departures and a slew of new policies.
    • “A lawyer for Tidmarsh, Joseph Galda, said that he didn’t solicit a bribe.” * * *
    • “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” the spokeswoman said.” 

From the public health and medical / Rx research front,

  • NPR Shots reports,
    • “In April, the future was looking bleak for an experimental Alzheimer’s drug called valiltramiprosate, or ALZ-801.
    • “Researchers had just released topline results of a study of more than 300 people age 50 or older, who were genetically predisposed to Alzheimer’s. Overall, those who got the drug did no better than those given a placebo.
    • “But in September, a closer look at the results revealed benefits for a subgroup of 125 people who had only mild memory problems when they started taking the drug.
    • “Those participants, initially diagnosed with mild cognitive impairment rather than mild dementia, “showed very meaningful responses,” says Dr. Susan Abushakra, chief medical officer of Alzheon, the drug’s maker.
    • “By one measure, the drug slowed cognitive decline by 52% in people with mild cognitive impairment. That result appears comparable with benefits from the two Alzheimer’s drugs now on the market: lecanemab and donabemab.”
    • Further studies are underway.
  • Medscape discusses ongoing advances in anti-obesity medication and separately notes
    • “Analysis of 35,213 patients with stage II-III colon cancer revealed that recurrence risk drops below 0.5% at 6 years post-surgery, supporting a practical definition of cure. Women showed a significantly lower recurrence risk with a hazard ratio (HR) of 0.58.” * * *
    • “From a scientific perspective, we still face challenges in the definition of cure in the adjuvant colon cancer setting. When answering patients’ questions about cure, we should use a restrictive definition of relapse-free survival, considering local and/or distant recurrence; this should be reported in adjuvant studies as a relevant secondary endpoint. In the setting of colon cancer, this leads us to advocate for 6 years after surgery free of relapse as constituting cure,” the authors of the study wrote.”
  • JAMA discusses “What to Know About the New Blood Pressure Guidelines” for adults released in August 2025.
    • “Some things haven’t changed in the new high blood pressure (BP) guideline for adults released this August by the American Heart Association (AHA) and the American College of Cardiology. The definitions of normal, elevated, and stage 1 and 2 hypertension are the same, for example. And the recommended first-line antihypertensives are unchanged from the 2017 guideline.
    • “But many updates with the potential to change patient care were included in the new guideline, which incorporates the latest data and emphasizes both earlier treatment and tighter control of BP.
    • “With heart health, brain health, kidney health…overall we have really great evidence that lower blood pressure is better,” said guideline coauthor Sadiya S. Khan, MD, MSc. “Start blood pressure treatment earlier and get to lower targets.”
    • “Plus, there’s much more attention on prevention in the new guideline—meaning recommendations even for people with normal BP.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports
    • “The gloves are off in the obesity-drug fight. But Novo Nordisk NOVO.B might be swinging so hard it risks losing its balance.
    • “The maker of Ozempic has been losing ground to Eli Lilly LLY and a crop of copycat GLP-1 makers such as Hims & Hers Health HIMS. Novo’s new chief executive, Mike Doustdar, deserves credit for shaking up a once-stodgy Danish pharma with a move fast and break things mindset. He inherited a company rapidly ceding share, and his response has been urgent: layoffs to free up cash for reinvestment, and a dealmaking spree that included the acquisition of Akero Therapeutics, a company with a liver-disease treatment, for up to $5.2 billion.
    • Now, Novo’s bid to regain its footing has taken a form unthinkable under past leadership: an unsolicited $9 billion offer to pry Metsera MTSR, the developer of a monthly injection, away from Pfizer PFE, which had agreed to buy it in a deal valued at up to $7.3 billion. It is a bold move for a company that mostly shied away from dealmaking under past leadership.
    • In this case it also looks like a move born of frustration, one that is now making Novo investors uneasy. The stock skidded Thursday and Friday as investors questioned how confident the pharma company is in its own obesity-drug pipeline, said Will Sevush, a healthcare strategist at Jefferies.
    • On Friday, Pfizer sued Novo and Metsera, alleging that under the terms of the Pfizer-Metsera agreement, the offer from Novo can’t qualify as superior. Pfizer might have a point.” * * *
    • “Even so, Pfizer—which had recently been fending off an activist investor as patents on key drugs expire and Covid revenue fades—still has time to decide it is better to negotiate than fight. Metsera seems to be using Novo’s offer as leverage to extract a sweeter deal, and under the merger terms, Pfizer has until Tuesday to counterbid. Given how valuable GLP-1 drugs have become, a small bump in price could be worth it.”
  • TechTarget unveils a patient survey about their attitudes towards the use of artificial intelligence in healthcare.

Friday Report

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

Happy Halloween!!

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the AI front,

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

In Memoriam

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

Midweek update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

In Memoriam

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

RIP.

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the AI front,

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

Monday report

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

From Washington, DC

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Weekend update

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

From Washington, DC

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

From the public health and medical / Rx research front,

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

From the healthcare business front,

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