Friday report

Congress

Friday report

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

From Washington DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the healthcare business front,

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

Midweek update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the HLTH 2025 Conference

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the HLTH 2025 Conference

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the HLTH Conference,

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

From the U.S. healthcare business front,

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

Weekend Update

David Ermer–Congress, Congress, COVID-19 vaccine, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • On Thursday, the Senate Committee on Aging will hold a hearing at 3:30 pm ET “to examine modernizing health care, focusing on how shoppable services improve outcomes and lower costs.”
  • The Wall Street Journal reports that “Congress Is running out of time to decide the fate of Obamacare subsidies. Republicans decry the ‘Biden bonuses’ of enhanced ACA, while Democrats say pressure will rise on GOP to extend subsidies.”
    • “Enhanced Affordable Care Act subsidies, benefiting more than 20 million people, are set to expire this year, prompting a political standoff.
    • “Republicans seek major changes to the ACA, including addressing alleged fraud.
    • “ACA sign-ups have more than doubled since 2021. More than three-quarters of policyholders now reside in states that voted for President Trump.”
  • Roll Call adds,
    • “President Donald Trump is expected to host Senate Republicans for a Rose Garden lunch Tuesday, while the ongoing partial government shutdown continues to have no end in sight.
    • “A GOP source confirmed the plan for the White House visit, which comes as the Senate majority will also try this week to call up a bill that would pay federal workers who are on the job during the shutdown. The Senate this week is also expected to continue to confirm Trump’s judicial nominees.”

From the 2025 European Society for Medical Oncology congress in Berlin,

  • STAT News reports,
    • “Patients with a highly aggressive form of breast cancer will likely have new treatment options for the first time in years after AstraZeneca and Gilead Sciences both presented successful trial results here Sunday, dual achievements that will also leave clinicians having to figure out which drug to choose when treating triple-negative tumors. 
    • “Both studies tested what’s known as an antibody-drug conjugate — essentially, a next-generation type of chemotherapy — compared to traditional chemotherapy regimens as a first-line medicine in patients with metastatic triple-negative breast cancer who couldn’t receive an immunotherapy. The women largely weren’t eligible for treatments like checkpoint inhibitors because their tumors did not express the protein that the drugs target. For these patients, there hasn’t been a new first-line drug approved in over a decade.
    • “Researchers were already going to be comparing the results of the two Phase 3 studies in the difficult-to-treat tumors, but the stakes were upped with the trials being presented back-to-back here at the European Society for Medical Oncology’s annual conference. A single discussant also analyzed the results together, parsing the outcomes for Gilead’s Trodelvy as well as for Datroway, made by AstraZeneca and its partner Daiichi Sankyo.” 
  • and
    • “mRNA-based Covid vaccines from Pfizer-BioNTech or Moderna may have an unexpected benefit for cancer patients who undergo immunotherapy. 
    • “A new study suggests that these vaccines might boost the effects of immunotherapy drugs, perhaps by alerting the immune system and helping direct immune cells to attack tumors. That’s in addition to helping protect against Covid, which can be particularly important for cancer patients who can sometimes have weakened immune systems. 
    • “The study found that advanced cancer patients who received a Covid vaccine within 100 days before taking an immunotherapy drug during the pandemic lived longer than patients who did not, in a retrospective analysis. Researchers from MD Anderson Cancer Center presented the study at the European Society for Medical Oncology conference in Berlin on Sunday. 
    • ‘The results are intriguing cancer immunologists and oncologists, who reacted with both excitement and caution.” 
  • Fierce Pharma adds,
    • “Novartis has shared detailed data showing its radioligand therapy Pluvicto could slow the progression of certain hormone-sensitive prostate cancers ahead of a planned application with the FDA.
    • “Pluvicto plus standard of care significantly reduced the risk of radiographic progression or death by 28% versus standard of care alone in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), according to Novartis. The standard of care includes androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) such as Pfizer and Astellas’ Xtandi.
    • “Details from the phase 3 PSMAddition trial will be presented Sunday at the 2025 European Society for Medical Oncology congress in Berlin.”
  • and
    • “The standing ovation for Keytruda and Padcev in metastatic bladder cancer at the 2023 European Society for Medical Oncology (ESMO) Congress still echoes, and, now, the pair from Merck & Co., Pfizer and Astellas has pulled off similarly showstopping results in certain patients with muscle-invasive bladder cancer (MIBC).
    • “The combination of Merck’s Keytruda and Pfizer and Astellas’ Padcev reduced patients’ risk of death by a whopping 50% when used before and after bladder removal surgery in those with MIBC who are not eligible for or declined cisplatin-based chemotherapy compared with surgery alone, according to results to be presented at the 2025 ESMO Congress.
    • “The PD-1/antibody-drug conjugate combo also significantly improved event-free survival (EFS) by 60% versus surgery alone. A negative event includes progression of disease that precludes surgery or failure to undergo surgery, gross residual disease left behind during surgery, cancer recurrence or death.”
  • and
    • “Merck’s efforts to make headway in a cancer type that was an elusive target for its superstar oncology med Keytruda prove to be fruitful, as demonstrated through its Keynote-B96 trial in ovarian cancer. 
    • “The latest data drop is a more detailed look at a win from previously reported positive analyses of the phase 3 study, which tested Keytruda plus chemotherapy with or without Roche’s Avastin in patients with platinum-resistant recurrent ovarian cancer who have tried one or two prior lines of therapy, including at least one platinum-based chemotherapy.”

From the public health and medical / Rx research front,

  • The Washington Posts offers expert advice on when to obtain Covid and flu boosters for this coming, winter infection season. Both infectious disease physicians encouraged getting the shots in October.
    • “[Dr.] Pavia encourages getting a shot whenever you have an easy opportunity. If you’re getting groceries and the pharmacy is offering flu shots, take five minutes to get one, because you are less likely to follow through by scheduling an appointment, Pavia said.
    • “The Centers for Disease Control and Prevention now recommends that people consult a clinician before receiving a coronavirus shot, but that process can be as simple as a brief conversation with a pharmacist. The Post previously published a guide to getting covid shots under these new conditions.
    • “By now, many people know how they react to flu and coronavirus shots. The coronavirus shot can give some people quite a sore arm. If that’s the case, avoid getting both shots in the same arm, they said. [Dr.] Rivers got her shots in two different arms during the same visit, but the rest of her family got them in the same arm. For people who don’t have much a reaction, there is no disadvantage to getting two shots at the same time, [Dr.] Pavia said. He got his shots at different times because that’s when it was convenient for him.”
  • The American Medical Association offers healthcare providers advice on how to answer patients’ questions about vaccinations.
  • The New York Times explains why more older adults have turned to cochlear implants after Medicare expanded eligibility for the devices.
    • “Twenty-five years ago, “it was a novelty to implant people over 80,” said Dr. Charles C. Della Santina, director of the Johns Hopkins Cochlear Implant Center. “Now, it’s pretty routine practice.”
    • “In fact, a study published in 2023 in the journal Otology & Neurotology reported that cochlear implantation was increasing at a higher rate in patients over 80 than in any other age group.
    • “Until recently, Medicare covered the procedure for only those with extremely limited hearing who could correctly repeat less than 40 percent of the words on a word recognition test. Without insurance — cochlear implantation can cost $100,000 or more for the device, surgery, counseling and follow-up — many older people don’t have the option.
    • “It was incredibly frustrating, because patients on Medicare were being excluded,” Dr. Della Santina said. (Similarly, traditional Medicare doesn’t cover hearing aids, and Medicare Advantage plans with hearing benefits still leave patients paying most of the tab.)
    • “Then, in 2022, Medicare expanded cochlear implant coverage to include older adults who could identify up to 60 percent of words on a speech recognition test, increasing the pool of eligible patients.”

From the U.S. healthcare business front,

  • Medscape considers whether the obesity drug battleground is offering wins for clinicians and patients?
  • TechTarget reports,
    • “Teladoc Health has launched new AI capabilities that enable care teams to monitor and mitigate violence in healthcare workplace settings.
    • “The virtual care provider has integrated the new AI features into its Clarity monitoring solution. The AI technology utilizes video and audio cues to assess facial expressions, gestures and language to determine threats. If a situation is deemed potentially aggressive and appears to be escalating, the solution will notify the appropriate care teams and staff. For example, it will identify safety risks, such as a person aggressively tampering with medical equipment.”
  • The Wall Street Journal relates,
    • “Provalus, an outsourcing company, is expanding revenue by 35% to 40% annually as it invests in rural American towns.
    • “The company recruits and trains individuals from small towns, offering jobs in IT and professional services with competitive benefits.
    • “Provalus aims to create middle-class jobs in overlooked areas.”
  • Per HR Dive,
    • “While 7 in 10 U.S. hiring managers say they typically consider overqualified candidates, many also express concerns about low engagement and quick exits, according to an Oct. 8 report from Express Employment Professionals and The Harris Poll.
    • “In fact, three-quarters of employers said they believe overqualified hires struggle to stay motivated in lower-level roles, and they worry these hires will leave as soon as a better opportunity comes along. In response, 58% said they’d rather train someone new than risk disengagement.”

Friday report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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

Midweek report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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

Tuesday’s report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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