Monday report

OPM

Monday report

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

From Washington, DC

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

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.” 

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.”

Columbus Day Holiday Report

David Ermer–Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

Supplementing yesterday’s Weekend Update

From Washington, DC,

  • The AP reports,
    • “President Donald Trump said Saturday that he has directed the Defense Department to use “all available funds” to ensure U.S. troops are paid Wednesday despite the government shutdown, a short-term fix that will not apply to the hundreds of thousands of federal workers who have been furloughed.
    • “Trump said in a social media post that he was acting because “our Brave Troops will miss the paychecks they are rightfully due on October 15th.”
    • ‘The Republican president’s directive removes one of the pressure points that could have forced Congress into action, likely ensuring that the shutdown — now in its 11th day and counting — extends into a third week and possibly beyond. But no similar action seems forthcoming for federal employees also working without pay while thousands are now being laid off during the lapse in government operations.”
  • Federal News Network tells us,
    • “The number of federal employees filing retirement claims in September was the lowest all year. Just over 6,300 employees submitted their retirement paperwork to the Office of Personnel Management. At the same time, OPM also processed the fewest number of current claims in September, just over 7,900. Despite the lower number of claims, OPM said it took six days longer, on average, in September than in August to process claims. The current retirement claims backlog is at 23,500, which dropped for the fourth straight month.”
  • The Washington Post interviews OPM Director Scott Kupor and others about the coming surge of retirement applications.
  • Per Beckers Payer Issues,
    • “The No Surprises Act is succeeding in protecting patients from unexpected medical bills, but insurers and provider groups remain divided on what is driving rising costs tied to the Independent Dispute Resolution process and how regulators should respond.
    • “Since the arbitration system launched in 2022, providers have won the vast majority of disputes. In 2024, they prevailed in about 85% of cases, with median payment determinations reaching 459% of the qualifying payment amount in the fourth quarter. The process has also generated at least $5 billion in costs, much of it from administrative fees and higher payments.
    • “As those costs have climbed, payers have said that the system is inflating prices across the healthcare system, while providers say it is correcting years of underpayment.
    • “The concern now is that the law hasn’t met its second objective, to contain costs,” Jennifer Jones, senior director of legislative and regulatory policy at the Blue Cross Blue Shield Association, told Becker’s. “That’s primarily because of the challenges we’re seeing with the independent dispute resolution process.”
  • The FEHBlog agrees with Ms. Jones.

From the public health and medical / Rx research front,

  • MedPage Today informs us,
    • “Among older adults who received at least one dose of the recombinant shingles vaccine, vaccine effectiveness against any herpes zoster-related outcome was 56.1%.
    • “Getting a second dose yielded a relative vaccine effectiveness of 67.9% against any herpes zoster outcome.
    • “The findings emphasize the importance of completing the full vaccination series.”
  • The Washington Post reports,
    • “The tendency to use cannabis is associated with genes linked to impulsive behavior, obesity, schizophrenia and bipolar disorder, among other traits, according to a study released Monday by researchers at the University of California at San Diego.
    • “The research, published in the journal Molecular Psychiatry, explored the genetic traits of casual and frequent cannabis users in hopes of eventually identifying medications and other therapies to treat or prevent problematic marijuana use.
    • “The study adds to a growing body of genetics research into cannabis use as policymakers and researchers weigh how to balance the benefits and consequences of the drug’s growing popularity.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Many nonprofit hospitals and health systems have made steady progress on financial turnarounds since the end of the COVID-19 pandemic — though others continue to struggle — but new and persistent challenges threaten to derail those efforts.
    • “Operating margins have inched upward across the sector, yet most remain far below the pre-pandemic “magic number” of 3%. The latest data from Strata Decision Technology shows that health system margins improved slightly to 1% in August, up from 0.9% in July, but remain relatively unchanged for the year. 
    • “While operating revenue has generally increased, it continues to be offset by rising costs — particularly in non-labor categories (such as supply and drug costs), which rose 5.7% year over year compared to a 4.6% rise in labor expenses.
    • “These pressures could intensify in the months ahead.” 
  • Beckers Payer Issues adds,
    • “When a critical patient’s prognosis is unclear, often because they are unable to wean from the ventilator, care teams begin to discuss palliative care, advance care planning, and even hospice.  Making decisions about long-term care goals can be challenging for patients and their families as they navigate the complexities of their conditions. Discussions often take place over many days while patients and families evaluate the options.  Including long-term-acute care hospital (LTACH) referral in these discussions benefits the patient for three reasons [explained in the article].

Friday report

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

From Washington DC,

  • Here is a link to today’s Secrets of OPM blog post by OPM Director Scott Kupor.
  • Here are links to Fedweek and Fedsmith articles about OPM’s 2026 government contribution announcement made yesterday.
  • Yesterday, the FEHBlog posted the Internal Revenues Service’s 2026 inflation adjusted amounts.
    • The Wall Street Journal discusses how the adjustments impact federal income taxation.
    • Newfront discusses how the adjustments impact employee benefits.
  • Healthcare Dive notes,
    • “Average Medicare Advantage star ratings for 2026 are essentially flat after a few consecutive years of declines — a good sign for the industry, which had braced itself for lower quality scores.
    • “Still, there was variation in major insurers’ results. The percentage of members in plans rated 4 stars or above, an important cutoff for payers, stayed stable for UnitedHealthcare, dropped for Humana and Aetna, and improved for Elevance and Centene — the five largest publicly traded payers in the privatized Medicare program.
    • “Perhaps the biggest loser is Clover Health. The insurer’s largest contract covering almost all of its MA members dropped below 4 stars — a slip that could cost Clover tens of millions of dollars in earnings, analysts estimate.”
  • The American Hospital Association News tells us,
    • “The federal government shutdown is expected to continue into next week as the Senate adjourned Oct. 9 after failing to pass spending legislation; senators plan to return Oct. 14. Meanwhile, the House currently has no plans to return to session next week. The Senate Oct. 9 failed to adopt the House-passed continuing resolution to fund the government following a seventh vote on the bill. Senate Republicans and Democrats have yet to begin formal negotiations toward a deal.”
  • Federal News Network points out,
    • “Hundreds of thousands of federal employees are set to receive reduced paychecks, now on day 10 of the partial government shutdown.
    • “While most civilian federal employees are expected to get their paychecks sometime in the next couple days, they’ll only take home the pay they earned up until the shutdown began. Regardless of whether they are excepted or furloughed, federal employees will not be paid for any days worked between Oct. 1 and Oct. 4 — the final few days of the most recent two-week pay period.
    • “With the partial paychecks, many federal employees will lose out on hundreds of dollars. The exact timing of when employees receive their paychecks depends on their agency, but many began going out Friday.
    • “It’s also the last paycheck excepted and furloughed employees will receive until the government shutdown ends. The first fully missed paycheck, if the shutdown continues, will be for the pay period of Oct. 5 through Oct. 18. Only federal employees who are considered “exempt” from the shutdown will continue to be paid as usual.”
  • Roll Call reports,
    • ​”The Trump administration made good on its threat to begin mass firings of federal civilian employees Friday while exploring creative avenues to make sure military personnel don’t miss their paychecks slotted to go out next week.
    • “With no end in sight to the partial government shutdown that began 10 days ago, White House budget director Russ Vought announced on X that he has begun executing mass layoffs across federal agencies.
    • “An Office of Management and Budget official said the layoffs are “substantial,” without elaborating. Details began trickling out ahead of a court-ordered deadline by close of business Friday, however, hitting numerous agencies including Treasury, EPA, Homeland Security, Education, and Housing and Urban Development, among others.
    • “Speaker Mike Johnson, R-La., meanwhile, officially canceled votes in the House next week, meaning there is virtually no chance that Congress could pass a stand-alone bill to provide pay to some 2 million troops whose next paycheck is due Oct. 15.
    • “But in keeping with President Donald Trump’s pledges to “take care of” the military while punishing “Democrat agencies,” his administration is looking at how to make sure the troops are kept whole financially. A senior White House official said the administration is “exploring every legal maneuver and option at our disposal to get our troops paid during the Democrat Shutdown.” 
  • STAT News informs us,
    • “The Senate on Thursday passed legislation that would restrict U.S. pharmaceutical and biotechnology companies from doing business with certain Chinese companies, potentially giving the president another way to pressure the industry into doing what he wants. 
    • “The BIOSECURE Act, which was passed as an amendment to the National Defense Authorization Act, has been a long time coming. A more aggressive version of the bill was introduced in the Senate in December 2023. The House proposed similar legislation the next month.
    • “BIOSECURE is not over the finish line yet, but it’s significant that the Senate included it in the National Defense Authorization Act, because the defense budget bill has passed every year for decades. The House passed its version of the defense bill earlier in the year without the BIOSECURE Act, so the two chambers would need to agree to include BIOSECURE in the final version of the defense budget bill when reconciling differences between their versions of it.”
  • The AHA News adds,
    • “The AHA discussed ways hospitals and health systems are leveraging artificial intelligence for care delivery in a statement submitted to the Senate Committee on Health, Education, Labor and Pensions for a hearing held Oct. 9 titled, “AI’s Potential to Support Patients, Workers, Children, and Families.” The AHA highlighted examples of AI applications in hospitals, such as diagnostic imaging, ambient listening tools and scheduling for patients and staff.
    • “Hospitals recognize that AI tools hold tremendous promise to alleviate administrative burden and enhance clinical care,” the AHA wrote. “Among other benefits, these innovations can improve workflow, enhance the overall patient experience by reducing wait times and support timely medical interventions.”
    • “The AHA also discussed potential risks of AI in health care, such as commercial insurers using it to determine disposition of claims and prior authorizations, which has exacerbated inappropriate denials. The AHA advocated for the use of clinicians to independently review care recommendations.”
  • The University of Minnesota’s CIDRAP relates,
    • “A federal vaccine advisory group has established a panel to review the safety and efficacy of the childhood immunization schedule, according to a document posted yesterday on the Centers for Disease Control and Prevention (CDC) website.
    • “The Childhood and Adolescent Immunization Schedule Workgroup (WG), established within the CDC’s Advisory Committee on Immunization Practices (ACIP), will review data and “clinical and scientific knowledge” and present its findings to help ACIP members make policy recommendations. 
    • “As part of ACIP’s core mission to develop recommendations on the use of vaccines in the civilian population of the United States, the committee is standing up a WG focused on assessing the safety and effectiveness of the childhood and adolescent schedule,” the document states.
    • “Among the topics the group will review are the timing and order of different childhood vaccines, administering different vaccines at the same time, the safety of certain vaccine ingredients, and the different childhood vaccine schedules used in other countries.”

From the Food and Drug Administration front,

  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved another new treatment option for heart-failure related edema. 
    • “Just weeks after its approval of bumetanide nasal spray for the treating edema associated with congestive heart failure, kidney disease and liver disease, the agency has given the greenlight to Lasix ONYU, a new drug-device combination from SQ Innovation, for adult patients with chronic heart failure. 
    • “Lasix ONYU provides patients with injections of a high-concentration formulation of furosemide. The injections are delivered with a small two-in-one device. While the base of the device is reusable, only to be replaced after 48 treatments, the other part of the device is used once and then discarded. According to SQ Innovation, this new-look design helps ensure the delivery device can be manufactured at a low enough price point so the treatment remains affordable.
    • “In one recent analysis published in European Heart Journal – Cardiovascular Pharmacotherapy, researchers found that the Lasix ONYU technology was linked to a bioavailability similar to receiving furosemide through an IV. Treatment was also confirmed to be “feasible and well tolerated.”

From the. public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention is not updating its respiratory illnesses data channel during the shutdown.
  • Dr. Tom Friden, a former CDC Director, writes in the Wall Street Journal about the simple steps that can prevent dementia.
    • “When it comes to healthy aging, personal responsibility matters. But American healthcare also suffers from systemic failures. Despite spending more than $4 trillion annually, we get the most important things, such as blood pressure control, right at most half the time. Our system doesn’t incentivize doctors to deliver the preventive care that matters most. For instance, they are paid little or nothing for making an effort to control a patient’s blood pressure.
    • “The tools for a healthy, dementia-free future exist: blood pressure control, appropriate statin and other therapy, smoking prevention and cessation support, and comprehensive primary care focused on prevention. We need a healthcare system that delivers them reliably, for all our sakes.”
  • Per Health Day,
    • “Heart-related health problems might affect as many as 1 in 7 pregnancies, even among women without any prior heart disease, a new study says.
    • “Researchers found a steady increase in heart-related health problems among more than 56,000 pregnancies between 2001 and 2019 in New England.
    • “Heart attack, stroke, heart failure, blood clots, high blood pressure and heart-related maternal death affected about 15% of pregnancies during that time, researchers reported Oct. 6 in the journal Circulation.
    • “Our findings showcase an alarming trend of rising real-world burden of pregnancy-related cardiovascular complications and highlights pregnancy from preconception to the postpartum period as a crucial window of opportunity to implement primary prevention strategies and optimize cardiovascular health,” concluded a team led by Dr. Emily Lau, a cardiologist at Massachusetts General Hospital in Boston.”
  • Per MedPage Today,
    • “New-onset atrial fibrillation (Afib or AF) was surprisingly common after coronary artery bypass grafting (CABG), but its burden quickly diminished to near zero after 30 days, according to long-term continuous ECG monitoring data.
    • “With a monitor implanted during surgery, patients at two German centers showed a 48% incidence of new-onset Afib in the first year after CABG, with a median Afib burden of 0.07% (or 370 minutes).
    • “It turned out that on days 1-7, the median Afib burden was 3.65% (368 minutes), dropping quickly thereafter to 0.04% (13 minutes) on days 8-30 and 0% (0 minutes) on days 31-365, according to researchers led by Florian Herrmann, MD, of LMU University Hospital in Munich, Germany.
    • “Although the incidence of new-onset AF after CABG in this study was higher than previously reported, the AF burden in these patients was very low, especially after 30 days,” the authors reported in JAMA.
    • “This low burden calls into question whether long-term oral anticoagulation is necessary in patients with new-onset AF after CABG. The very low burden provides a likely explanation for why observational studies have failed to demonstrate reduced stroke rates with oral anticoagulation in this patient group,” Herrmann’s group suggested.”
  • Per the American Journal of Managed Care,
    • “A smartphone app significantly reduced depressive symptoms and improved self-esteem and quality of life in individuals with intellectual disabilities.
    • “The study addressed a research gap, highlighting the app’s potential as an accessible mental health intervention for an underserved population.
    • “Limitations include self-reported data, potential bias, and lack of long-term follow-up, affecting the generalizability of results.
    • “Future research should explore optimal app use, caregiver involvement, and accessibility barriers to enhance mental health support for individuals with IDs.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “AstraZeneca is the latest major drugmaker to agree to a deal with the Trump administration on lowering the prices of its drugs, some of which will be available for purchase through a government website next year, President Trump said Friday. 
    • “The agreement, which entails offering “most-favored nation” drug pricing, follows Pfizer’s deal to reduce prices for its drugs sold in the Medicaid program and through a new direct-purchasing service to be branded TrumpRx.
    • “AstraZeneca will similarly offer all prescription drugs on the government website, TrumpRx, which the administration said it will launch in 2026, said Mehmet Oz, administrator for the Centers for Medicare & Medicaid Services.
    • “In addition to the lower drug prices for people on Medicaid, all new AstraZeneca drugs introduced to the market will be launched at most-favored nation pricing, which is tied to comparable prices in other wealthy nations.” 
  • Reuters adds,
    • “Retail pharmacies and prescription drug savings site GoodRx (GDRX.O)
      are talking with the Trump administration about joining its TrumpRx website, they told Reuters, suggesting an expansion beyond the early description of it as a link to pharmaceutical companies’ direct discounts.” * * *
    • “The National Community Pharmacists Association and the National Association of Chain Drug Stores, which represent companies like Walgreens and Costco (COST.O), said they were also talking with administration officials.”
  • The Wall Street Journal also lets us know,
    • “Johnson & Johnson JNJ is in talks to buy Protagonist Therapeutics in a deal that would solidify the companies’ existing partnership, according to people familiar with the matter.
    • “A deal is not guaranteed and the exact details being discussed couldn’t be learned, the people said. 
    • “Protagonist had a market value of over $4 billion as of Thursday’s close. Including a typical premium, a deal would likely value the company well above that. 
    • “”J&J is already working with Protagonist to develop an oral treatment for immune diseases including plaque psoriasis and ulcerative colitis and has the exclusive rights to commercialize the product. It already owns close to 4% of Protagonist’s shares, according to FactSet.
    • “By acquiring Protagonist, the healthcare conglomerate would also gain access to the drug rusfertide, from Protagonist and partner Takeda Pharmaceutical4502 -2.63%decrease; red down pointing triangle. Rusfertide has shown promise in late-stage testing in treating a rare blood cancer called polycythemia vera. 
    • “Both assets would complement J&J’s portfolio of immune and cancer drugs.” 
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is joining big pharma’s rush into “in vivo” cell therapies, paying $1.5 billion to acquire Orbital Therapeutics for a technology designed to rewire the immune systems of people with inflammatory conditions.
    • “The deal announced Friday gives Bristol Myers ownership of a company that’s been working on ways to genetically modify immune cells inside the body. Orbital’s lead program, OTX-201, does so by sending into cells “circular” RNA instructions training them to seek out cells with a particular protein flag. OTX-201, which is envisioned as an autoimmune disease treatment, could begin human testing next year.
    • “The acquisition expands Bristol Myers’ presence in cell therapies. The company is already one of the field’s leaders, with multiple marketed medicines for blood cancers. But, like its peers, Bristol views autoimmune disorders as a way to potentially broaden use of the complex treatments.”
  • Per MedTech Dive,
    • “Zimmer Biomet has launched two orthopedic devices with Paragon 28, the foot and ankle specialist it bought for $1.1 billion early this year. 
    • “The new products, which Zimmer reported Wednesday, add treatments for a type of shinbone break and hindfoot injuries to the company’s portfolio.
    • “Introducing the devices continues Zimmer’s efforts to maintain Paragon’s double-digit growth and expand its sports medicine, extremities and trauma (SET) business.”
  • The Employee Benefits Research Institute released its 2025 Employer Mental Health Survey.
  • Fierce Healthcare adds,
    • “Most employers offer coverage for mental health services, but where they fall short is in tracking whether those benefits are working, according to a new survey.
    • “The report, conducted by the Employee Benefit Research Institute (EBRI), found that 97% of employers offer mental health coverage and 67% offer coverage for substance abuse treatment. However, only 22% said they actively monitor whether employees are using the benefits.
    • “In addition, there is a significant opportunity for employers to do more in tracking network adequacy, the study found. Forty-seven percent of those surveyed said they receive details from vendors or collect data on provider-to-enrollee ratios, while 44% said they track employees’ distance to providers and 48% said they monitor wait times.
    • “Fewer than one-third (31%) said they collect data on out-of-network care use, which is a major barrier to behavioral health access, per the report.”
  • KFF-Peterson Health System Tracker studies “how much do people with employer plans spend out-of-pocket on cost-sharing?”
    • “By cost-sharing type, average spending on deductibles and coinsurance has increased, while copayments have remained flat relative to inflation since 2013. However, since 2021, inflation (16%) and spending on deductibles (13%) have grown at similar rates. Deductibles rose rapidly before 2019, however starting in about 2019 employers have held deductibles constant.
    • “In 2023, 66% of people with employer coverage spent at least $100 on out-of-pocket health care expenses. Among them, 39.7% spent between $100 and $999 on average, while 26% spent $1,000 or more. Over time, the share of enrollees facing over $1,000 in annual out-of-pocket costs has steadily increased.  Conversely, 18% of people with employer coverage incurred no out-of-pocket costs, and 15.4% spent less than $100 in 2023.
    • “Regarding total health spending, 56% of people with employer coverage spent $1,000 or more, including 41% who spent between $1,000 and $9,999 and 15% who spent $10,000 or more. Meanwhile, 12% of enrollees used no health care billed to their health plan in the year, which further highlights the uneven distribution of health care costs across the insured population under employer plans.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Health Economics Methods Advisory (HEMA) yesterday released its first ever Draft Report focused on the assessment of the benefits of treatment that are appropriate to consider in economic evaluation for health technology assessment (HTA) decision-making.
    • “HEMA has been convened by the leaders of three global HTA organizations to independently assess new methods and processes. The three institutions include ICER, England’s National Institute for Health and Care Excellence (NICE), and Canada’s Drug Agency (CDA-AMC).
    • “This draft report will be open for public comment until October 30, 2025, providing a unique opportunity for all stakeholders to engage in the report development process.
    • “If you are interested in submitting a public comment on the Draft Report, visit https://hemamethods.org/our-research/.”

Thursday Report — 2026 Government Contributions Announced

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • Federal News Network informs us,
    • “Federal employees and annuitants are heading for yet another year of large increases to their health insurance premiums, in both the Federal Employees Health Benefits (FEHB) program and the Postal Service Health Benefits (PSHB) program.
    • “The Office of Personnel Management announced Thursday that FEHB participants will pay an average of 12.3% more toward their insurance premiums starting in January 2026 — or in dollars, an average of $26.40 more per pay period.
    • “The upcoming 12.3% premium spike follows multiple large premium increases over the last few years for FEHB enrollees. Federal employees saw an average of a 13.5% increase for the 2025 plan year — the largest year-over-year increase in well over a decade. Feds also saw a 7.7% jump in 2024, and an 8.7% increase in 2023.
    • “The PSHB program, which is open to more than 2 million USPS employees, annuitants and family members, is also set for a large premium increase for 2026. Enrollees in PSHB will be paying 11.3% more, on average, toward their 2026 premiums. In dollars, that’s about $21.51 more per pay period.” * * *
    • “When accounting for the government’s share of FEHB costs, which is increasing by about 9.2%, premiums will rise by 10.2% overall. PSHB premiums are increasing by 9% overall, when including the government’s portion of the cost, which is going up by 8%.”
  • Per an OPM news release,
    • “Today, the Office of Personnel Management (OPM) announced the 2025 Federal Benefits Open Season will be held from November 10 through December 8, 2025, and the 2026 plans and premiums for Federal Employees Health Benefits (FEHB) Program, Postal Service Health Benefits (PSHB) Program, and Federal Employees Dental and Vision Insurance Program (FEDVIP) are now available for review
    • “This is the opportunity for eligible federal and postal employees and annuitants to enroll or make changes to their health, dental, and vision coverage for the upcoming year.
    • “During Open Season, we want to give enrollees the opportunity to review their coverage, compare coverage options, and make the choice that is right for them,” Associate Director for Healthcare and Insurance Shane Stevens said. “I strongly encourage all employees to reassess their current coverage and choose the plans that best meet their family’s needs.” * * *
    • “Read Associate Director Stevens’ blog post about this year’s Open Season here. Read how to prepare for Open Season here.”
  • Here is a link to Govexec’s article about the OPM announcement.
  • Modern Healthcare reports,
    • “Medicare Advantage insurers suffered another disappointing year under the Star Ratings quality measurement program. 
    • “The average Medicare Advantage star rating for 2026 is essentially flat at 3.66, compared with 3.65 for 2025, according to data the Centers for Medicare and Medicaid Services released Thursday.
    • “Just over four in 10 Medicare Advantage contracts — which are bundles of plans — earned at least four of five stars, the threshold to qualify for the maximum 5% bonus payment, the same as this year. Eighteen contracts, or 3.5%, won five stars, up from seven for 2025. The annual enrollment period begins next Wednesday and ends Dec. 7.”
  • The Wall Street Journal reports.
    • “Republican and Democratic senators are trading ideas on healthcare funding to forge a path out of the government shutdown, as tensions rose on Capitol Hill ahead of what is set to be a painful week for government workers and military servicemembers.
    • “Informal discussions have centered on extending enhanced Affordable Care Act subsidies temporarily, but with new guardrails meant to cut back on aid for higher-income families. One cutoff point that has been discussed among Democrats: limiting the subsidies to households at or below $200,000 of income, rather than leaving the benefit uncapped.
    • “Sen. Angus King (I., Maine), who caucuses with the Democrats, has dubbed his approach the “two and two”—a two-year extension of the subsidy capped at $200,000 of income. Sen. Mark Kelly (D., Ariz.) said that a cap would be hard to implement this year, but that discussions were occurring about reducing the subsidy for next year by limiting the benefit to people making above a certain percentage of the federal poverty line, with some members aiming for a cap at $200,000 of household income.” * * *
    • “The government shutdown started Oct. 1, and many federal workers and troops are set to miss their first full paychecks next week.”
  • and
    • “The Trump administration said it isn’t planning to impose tariffs on generic drugs from foreign countries, after months of wrangling over whether to impose levies on the vast majority of drugs that are dispensed in the U.S.
    • “The administration has been weighing duties on a range of pharmaceutical products and ingredients, using a tariff investigation under Section 232 of the Trade Expansion Act of 1962, which covers threats to national security. President Trump last month posted online that he would impose 100% tariffs on name-brand drugs on Oct. 1 but didn’t mention generics. Trump ultimately delayed imposing tariffs, as officials said they would allow for more negotiations with drug companies.
    • “The administration is not actively discussing imposing Section 232 tariffs against generic pharmaceuticals,” White House spokesman Kush Desai said in a statement. A spokesman for the Commerce Department, which is handling the tariff investigation, similarly said that the 232 investigation wouldn’t result in tariffs on generics.
    • “The move, which isn’t final and could change in the coming weeks, comes after months of debate within the administration over how to bring manufacturing of generic drugs back to the U.S. and what role tariffs should play in that effort.”
  • The Internal Revenue Service helpfully posted a revenue procedure that “sets forth inflation-adjusted items for 2026 for various Code provisions as in effect on October 9, 2025.”
  • Beckers Clinical Leadership informs us,
    • “The federal government has directed the United Network for Organ Sharing to pause some of its oversight work amid the government shutdown.
    • “As the primary contractor for the Organ Procurement and Transplantation Network, UNOS manages the nation’s donation and transplant system, facilitating matches and monitoring patient outcomes.
    • “While critical services — including operation of the organ matching system and responding to serious patient safety risks — will continue, the OPTN has been ordered to pause much of its routine oversight responsibilities. As a result, many committee meetings have been canceled, a UNOS spokesperson told Becker’s. One specific area of work being paused is the monitoring of reports for policy implementation on heart and lung transplants. 
  • MedCity News discusses the application of the White House’s artificial intelligence action plan to healthcare.
    • “Healthcare and life sciences are about to face unprecedented AI-driven regulatory changes that will reshape everything from research and development to drug approval submissions. Here are 10 steps healthcare and life sciences organizations should take to strategically prepare.”
  • Bloomberg Law relates,
    • “The US Centers for Disease Control and Prevention will reschedule a late October meeting of an influential vaccine panel that’s been weighing changes to long-standing advice around childhood shots.
    • “The Advisory Committee of Immunization Practices, or ACIP, will no longer meet on Oct. 22 and 23, according to the panel’s website. No indication was given of when a future meeting will take place or why it was moved. 
    • “A US Department of Health and Human Services spokesperson said the meeting details would be posted online once they are finalized. ACIP typically only meets three times a year, though the upcoming October meeting was set to be its fourth gathering in 2025.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “In 2022, Regeneron paid Sanofi $900 million to gain full rights to its partnered cancer drug Libtayo. Three years later, the pricey bet on the injected PD-1 inhibitor appears to be paying off.
    • “Thursday, the FDA approved Libtayo as the first immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC). The nod applies to patients who are at a high risk of recurrence after surgery and radiation.”
    • “The green light comes seven years after Libtayo became the first drug to reach the market in CSCC, as it was endorsed for patients with metastatic CSCC or those with locally advanced CSCC who are not candidates for surgery or curative radiation.”
  • Per Cardiovascular Business,
    • “San Francisco-based Bunkerhill Health has received U.S. Food and Drug Administration (FDA) clearance for its new advanced artificial intelligence (AI) algorithm designed to detect and evaluate mitral annular calcification (MAC) on routine, non-gated CT scans.
    • “According to Bunkerhill Health, the AI model—known as Bunkerhill MAC—is the first AI model cleared by the FDA to identify signs of MAC, a known cardiovascular disease risk factor. It was developed and tested using data from more than 25 academic medical centers.
    • “MAC may be missed on imaging, but it carries prognostic value for cardiovascular risk and procedural outcomes,” Alexander Sandhu, MD, MS, assistant professor in the division of cardiology at Stanford University School of Medicine, said in a statement. Stanford is one of the schools that provided data for the development of Bunkerhill MAC. “A tool that can automatically identify and quantify MAC on routine chest CT scans gives us a way to capture this information consistently and at scale, which could help guide decision-making and research across cardiology and structural heart care.”

From the public health and medical / Rx research front,

  • Politico reports,
    • “The CDC and its independent panel of vaccine advisers have quietly opened the door to wider access to Covid-19 vaccination during pregnancy, softening an earlier decision by Health Secretary Robert F. Kennedy Jr. to stop recommending that pregnant women get the shots.
    • “The CDC’s Advisory Committee on Immunization Practices voted in September to advise that adults get the Covid-19 shot through shared clinical decision-making between patients and providers. It did not specifically vote on whether the shot should be administered during pregnancy, yet the vote appears to encompass pregnant women, according to an update this month on the CDC website that reflects the new guidance.
    • “The new guidance for adults means that pharmacies can administer the vaccine to pregnant women and almost all insurers must cover the shots with no cost sharing — expanding access.”
  • Cardiovascular Business tells us,
    • “Transcatheter aortic valve replacement (TAVR) is being used to treat a rising number of patients with severe aortic stenosis. However, according to a new commentary published in the Journal of the American College of Cardiology (JACC), this trend may have gone too far.[1] The authors fear that too many low-risk patients are undergoing TAVR when they should be considered for surgical aortic valve replacement (SAVR) instead.[1] 
    • “With some U.S. states documenting that nearly 50% of patients requiring aortic valve replacement aged <65 years receive TAVR rather than guideline-directed SAVR, a significant public health concern may be looming,” wrote first author J. Hunter Mehaffey, MD, MSc, a cardiac surgeon with West Virginia University (WVU), and colleagues. “While we await long-term data from trials, there are growing questions surrounding valve durability and reintervention rates, particularly in younger and lower-risk populations. These concerns include the potential deleterious effects of accelerated structural valve deterioration, and the commensurate rise in the need for premature surgical TAVR explantation.”
    • “Mehaffey et al. emphasized that the risks associated with SAVR are typically procedural. With TAVR, however, some risks persist for up to two years after treatment. In addition, the group added, many patients who care teams treat on a daily basis were excluded from the initial studies used to track the safety and effectiveness of TAVR in low-risk patients. This creates uncertainty about whether or not a patient with a bicuspid aortic valve, for example, should be treated with TAVR over SAVR.”
  • Healthcare Dive adds,
    • “Hospitals charged Medicare more than $1.9 billion over three years for more than 200,000 unnecessary, “low-value” back surgeries for older adults, according to a new analysis of claims data from the Lown Institute.
    • “That amounts to one unnecessary back procedure every eight minutes, according to the report, which analyzed the rates of spinal fusions and vertebroplasties — or surgeries that inject medical-grade cement into broken spinal bones to relieve pain.
    • “Back surgeries have come under scrutiny due to the high risk of complications — including including infection, blood clots and strokes — which can occur in up to 18% of patients, according to the report. “Reducing unnecessary procedures, particularly invasive ones that carry grave risks, is a moral imperative,” Dr. Vikas Saini, president of Lown, said in a statement.”
  • The New York Times relates,
    • “Surgeons in China have for the first time transplanted a section of liver extracted from a genetically modified pig into a human cancer patient, they reported on Thursday.
    • “The surgeons, who described the procedure in a paper in The Journal of Hepatology, grafted the portion of pig liver onto the left lobe of a 71-year-old patient’s liver after removing the larger right lobe, where a tumor the size of a grapefruit had grown. The lobe with the porcine transplant functioned, producing bile and synthesizing blood clotting factors, the surgeons reported. The patient’s body did not reject the organ graft, which enabled the remaining left lobe of the patient’s own liver to regenerate and grow, the scientists said.
    • “The porcine liver lobe was removed 38 days after the transplant, when complications developed, the surgeons wrote in the report. The patient, who had advanced disease, died a little over five and a half months later. He would not have been eligible to receive a human donor organ in China because he had advanced cancer and hepatitis B-related cirrhosis, the authors wrote.”
  • NBC News lets us know,
    • “Just as a single night of insomnia may leave you feeling groggy and cranky, solid slumber can help you feel rested and ready to take on the day. How well you sleep over time, however, can influence deeper aspects of your health and well-being, new research shows.
    • “Five distinct sleep patterns are tied to your health, lifestyle and cognition and even how different regions of your brain connect to one another, according to a study published Tuesday in the journal PLOS Biology. 
    • “Specifically, those “sleep-biopsychosocial profiles” encompass biological, psychological and socioenvironmental factors — such as having a safe, comfortable place to sleep — that contribute to your sleep hygiene.”
  • Per Health Day,
    • “A rare but dangerous form of breast cancer is on the rise in the United States, a new report says.
    • “Lobular breast cancer rates are rising three times as fast as all other breast cancers combined, 2.8% per year versus 0.8% per year, researchers reported Oct. 7 in the journal Cancer.
    • “Although lobular breast cancer accounts for a little over 10% of all breast cancers, the sheer number of new diagnoses each year makes this disease important to understand,” said lead researcher Angela Giaquinto, an associate scientist for cancer surveillance research at the American Cancer Society (ACS).
    • “Also, survival rates beyond seven years are significantly lower for (lobular breast cancer) than the most common type of breast cancer, highlighting the pressing need for prevention and early detection strategies targeting this subtype to be brought to the forefront,” Giaquinto added in a news release.
    • “Lobular breast cancer develops in the milk-producing glands of the breast, which are called lobules, researchers said in background notes.”
  • and
    • “Concussions and traumatic brain injuries (TBI) have been considered a potential cause of ALS, also known as Lou Gehrig’s disease.
    • “But a new study argues the association might be the other way around, with concussions providing an early warning sign among folks already in the early stages of ALS (amyotrophic lateral sclerosis).
    • “The loss of muscle control that comes with early ALS might increase people’s risk for a concussion-causing fall or accident; researchers write in JAMA Network Open.
    • “If that’s so, then “TBI in some individuals perhaps (reflects) a consequence of early, subclinical ALS,” concluded the research team led by Dr. William Stewart, a neuropathologist at Queen Elizabeth University Hospital in Glasgow, U.K.”
  • The FEHBlog recalls reading that Lou Gehrig suffered a lot of concussions as a baseball player in the days before batting helmets.

From the U.S. healthcare business front,

  • Fierce Pharma relates,
    • “AstraZeneca has broken ground on a $4.5 billion manufacturing facility near Charlottesville, Virginia, confirming a report about its location six weeks ago when state lawmakers approved an economic development package for the project.
    • “The company has added an additional $500 million to its original planned investment in the site, which will manufacture active pharmaceutical ingredient (API) for the production of weight management, metabolic and cardiovascular treatments, along with drugs from AZ’s growing antibody-drug conjugate (ADC) portfolio.
    • “AZ plans to create 600 full-time roles at the site, plus an additional 3,000 jobs during construction of the facility, according to an Oct. 9 press release.  The company expects the plant to come online in the next four to five years.”
  • Bloomberg points out,
    • “UnitedHealth Group Inc. plans to acquire a 45-doctor medical practice in Massachusetts in a sign that its Optum division will keep adding doctors despite turmoil in the business.
    • “The company’s Atrius Health affiliate has agreed to buy a Boston-area primary care group called Acton Medical Associates, PC, according to a notice posted by a Massachusetts regulator.
    • “The deal shows UnitedHealth continues to expand its reach in primary care and physician groups even as that part of its business has struggled. Physician groups are part of its sprawling Optum Health business, where executives said earnings were $6.6 billion below expectations in a July call with analysts.”
  • BioPharma Dive notes,
    • “Novo Nordisk will spend billions of dollars to grow its foothold in treating a common liver condition, agreeing on Thursday to buy Akero Therapeutics for a drug that’s currently in late-stage testing. 
    • “Novo will pay $54 per share, or about $4.7 billion upfront, for California-based Akero and its lead drug, known as efruxifermin. Akero stockholders could see another $6 per share in payouts via a so-called contingent value right if efruxifermin is approved by U.S. regulators.
    • “In buying Akero, Novo is adding to a recent upswing in dealmaking involving drugs for the liver disease known as metabolic dysfunction-associated steatohepatitis, or MASH. GSK bought one prospect from privately held Boston Pharmaceuticals in May, and Roche acquired another through a deal for 89bio last month. All three deals were centered around medicines that mimic the activity of a metabolism-balancing hormone called FGF21.” 
  • Per STAT News,
    • “With a flurry of startup activity, tech to monitor the symptoms of Parkinson’s disease is gaining traction in care.
    • “On Thursday, Kneu Health, a startup spun out of Oxford University research labs, announced $5.6 million in funding for its smartphone app-based platform that measures movement, speech, and cognitive changes in people with Parkinson’s over time. In addition to working with the U.K. National Health Service, Kneu is being trialed by Cedars-Sinai, which is an investor, and Mass General Brigham. It has raised $11.2 million to date.
    • “Over the summer, San Francisco-based Rune Labs quietly raised $11 million from its existing investors with plans to add more funding. The company has raised $57 million total to support its Parkinson’s technology, which uses an Apple Watch to track symptoms and boasts a growing partnership with Kaiser Permanente. Last week, wearable device and algorithm developer Empatica announced it had acquired PKG Health, another maker of Parkinson’s tracking tech that’s been used to care for 35,000 people. Empatica’s largest business is supporting pharma companies.”
  • Per Fierce Healthcare,
    • “Similar to Medicare, commercial insurers are seeing substantially higher prices when care is delivered in a hospital outpatient department as opposed to an ambulatory surgical center, according to a multi-payer analysis published this week.
    • “However, just how much those prices increase varies substantially between individual commercial payers, suggesting there’s more room for insurers to push down spending via selective provider contracting, Brown University researchers wrote in their Health Affairs study.
    • “The researchers said their analysis is unique in focusing on site-based payment differentials across multiple payers in the commercial insurance market, which have largely been overshadowed by investigations and debate over site-neutral payment policies for Medicare.
    • “Although insurers can, and do, pursue strategies to limit payment differentials across settings, large payment differentials remain common and costly,” they wrote in the journal.”
  • and
    • “When the government entered a partial shutdown Oct. 1, hospitals across the country faced a major task: discharging, relocating or shifting care programs for the thousands of patients in hospital at home programs. 
    • “With Congress at a standoff over healthcare cuts and Affordable Care Act premium tax subsidies, the body failed to reauthorize the Centers for Medicare & Medicaid Services’ (CMS’) pandemic-era Acute Hospital Care at Home program, along with Medicare telehealth services.
    • “The CMS directed the 419 participating AHCaH hospitals to discharge or relocate Medicare hospital at home patients if Congress did not extend the waiver. Health systems received the notice about 60 days in advance of the Sept. 30 deadline, and they received periodic reminders as the shutdown drew near. 
    • “In the days before the shutdown, hospitals ramped down admissions to hospital at home programs . Since the lapse of the waiver, home hospital providers have entered a complex maze of regulations and decisions.”
  • The Wall Street Journal reports,
    • “Drug Rehabs Lure in Patients for Insurance Money—Then Leave Them on the Street.”
    • “Operators promise high-end treatment, help addicts sign up for insurance then pile on charges for little in return, say former patients and insurers.:”
  • The FEHBlog observes that’s a big bowl of wrong.

Tuesday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Federal News Network tells us,
    • “The guarantee of back pay for furloughed federal employees is now in limbo, as the White House weighs a different interpretation of the 2019 law that ensures federal employees get compensated following a government shutdown.
    • “A new draft legal opinion from the Office of Management and Budget, as first reported by Axios, argues that whatever funding legislation Congress ultimately passes to end the current shutdown must explicitly include appropriations to provide back pay for furloughed federal employees. And if it’s not expressly written in the spending legislation, the OMB memo argues that furloughed workers cannot receive any retroactive compensation.
    • “A copy of the OMB document, which a senior White House official shared with Federal News Network, appears to contradict OMB’s previous interpretation of the Government Employee Fair Treatment Act, or GEFTA, which President Donald Trump signed into law in 2019 during the last government shutdown. Both OMB and the Office of Personnel Management previously affirmed that under GEFTA, excepted and furloughed employees would be given back pay as soon as possible, once any current or future shutdown ends.”
  • In the FEHBlog’s opinion, this draft OMB opinion is a lead balloon.
  • Healthcare Dive shares six takeaways from CMS Administrator Mehmet Oz’s appearance on Monday before a Washington D.C. think tank audience.
  • Modern Healthcare reports,
    • “Federal regulators say they have made inroads into speeding up the process to resolve out-of-network billing disputes. It’s not enough for frustrated providers and health insurance companies.
    • “The No Surprises Act’s Independent Dispute Resolution, or IDR, process has been a punching bag for both camps since it launched in 2022, and a backlog of cases had piled up by the beginning of this year.
    • “But the share of IDR cases unsettled after 30 business days fell from 69% in January to 34% in July, the most recent month for which data are available, according to the Health and Human Services, Labor and Treasury departments. Likewise, 96.5% of disputes submitted since 2022 are either resolved or are less than 30 business days old, the departments wrote in a notice published Sept. 19.
    • “The departments’ efforts have delivered remarkable improvements in the throughput of cases compared to prior years,” the notice says. “IDR entities are now resolving disputes faster than they are submitted.”
  • STAT News informs us,
    • “The agreement between Pfizer and the Trump administration to lower drug prices has sent other companies scrambling to make a deal.
    • “Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to show progress, with some hoping to announce a deal with the White House as soon as this week, according to five Washington representatives and lobbyists for the companies, granted anonymity to speak about private deliberations.”
    • “They have to now,” said one lobbyist of their clients’ thinking, noting the “anger”with Pfizer for effectively adding to their pressure to come to an agreement with the administration.
    • “The people cautioned that negotiations remain unfinished and several variables, including the government shutdown, could delay any announcements.
    • “The growing chatter around potential announcements signals the Trump administration’s pressure campaign may be paying off. But whether the deals will actually accomplish the administration’s objective — lowering prescription drug prices — remains unknown.”
  • Fierce Healthcare points out,
    • “The current state of the Medicare Part D market is a mixed bag, with premiums declining but many payers scaling back options, according to a new analysis from KFF.
    • “The report noted that the Centers for Medicare & Medicaid Services put an emphasis on “stability” in Part D when it announced premium estimates in late September, but KFF found that the total number of stand-alone Part D plans available will decrease in 2026, marking the third straight year of shrinking plan options.
    • “Some payers are trimming down their offerings, per the report. For example, Centene is ending three drug plans offered through WellCare and Health Care Service Corporation is discontinuing one of Cigna’s three Part D plans and pulling back from certain regions.
    • “Other insurers, such as Elevance Health, are exiting the stand-alone Part D plan market entirely.
    • “For 2026, beneficiaries in each state will be able to select from between eight and 12 stand-alone Part D plans, in addition to Medicare Advantage prescription drug coverage. Across the 34 Part D plan markets, a total of 360 plans will be made available by 17 parent organizations—a decrease of 22% from 2025.”
  • “As many major insurers scale back on Medicare Advantage,” Beckers Payer Issues takes a “look at the insurers that are fully backing out.”
  • NextGov/FCW explains how OPM Director Scott Kupor plans “to attract tech talent [to federal government employment] after months of workforce cuts.”
  • Per HR Dive,
    • “The U.S. Senate confirmed Brittany Panuccio, an assistant U.S. attorney for the Justice Department in Florida, as a commissioner for the U.S. Equal Employment Opportunity Commission in a 51-47 vote Tuesday. Panuccio’s confirmation was part of an en bloc vote on several nominations.
    • “Panuccio fills the seat vacated in December by Keith Sonderling, who was named deputy labor secretary in March, and gives Republicans a majority. Her term expires July 1, 2029. 
    • “Panuccio’s confirmation restores a quorum to EEOC, which has operated with only two commissioners since January, when President Donald Trump fired Democratic commissioners Charlotte Burrows and Jocelyn Samuels before the expiration of their terms.”

From the Food and Drug Administration front,

  • Healio adds,
    • “The FDA approved Zoryve cream 0.05% for the treatment of children aged 2 to 5 years with mild to moderate atopic dermatitis, according to a press release. 
    • “Currently, there are approximately 1.8 million children aged 2 to 5 years being treated with a topical therapy for AD. Zoryve (roflumilast, Arcutis) cream 0.05% is a once-daily, next-generation phosphodiesterase-4 inhibitor that offers a nonsteroidal option for children and their caregivers.
    • “It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and vice chair of the department of dermatology at University of California San Diego, said in the release. “Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reassuringly explains how to get a Covid booster vaccination under the CDC’s newly approved guidelines.
  • MedPage Today reports
    • “To prevent measles outbreaks, public health systems and clinicians should look below the 35,000-foot view of state- and county-level vaccination rates against measles, mumps, and rubella (MMR) and instead aim their focus on at-risk school districts and schools, according to a statewide analysis of Texas counties.”
  • and
    • “The pre-cooked pasta Listeria recall broadened to include pasta salads and prepared dishes at Kroger, Trader Joe’s, and more grocery stores.
    • “Some Hello Fresh meals may contain Listeria-tainted spinach, USDA’s Food Safety and Inspection Service warned.
    • “Chicken corn dog products from Foster Poultry Farms also were recalled after wood was found in the batter causing at least five injuries. (NBC News)”
  • Per Healio,
    • “Changing trajectories of heart health markers during young adulthood were associated with potentially increased risk for cardiovascular disease later in life, researchers reported.
    • “In addition, individuals who maintained higher levels of CV health through young adulthood had lower risk for incident CVD vs. those whose CV health was maintained at lower levels or declined, according to data published in JAMA Network Open.”
  • and
    • “Acupuncture needling greatly improved pain-related disability in older adults with low chronic back pain compared with usual care, a randomized controlled trial demonstrated.
    • “Acupuncture may be an effective and safe pain management tool for many older adult patients,” Lynn L. DeBar, PhD, MPH, a researcher at Kaiser Permanente Center for Health Research, told Healio. “While it is unlikely to take away all the pain, this study suggests that it can decrease pain-related disability substantively.”
  • The New York Times considers that “He was expected to get Alzheimer’s 25 years ago. Why hasn’t he? Scientists are searching for the secret in [76-year-old] Doug Whitney’s biology that has protected him from dementia, hoping it could lead to ways to treat or prevent Alzheimer’s for many other people.”
  • Per Health Day,
    • “Preschoolers who regularly overeat are likely swallowing their emotions as well, a new study says.
    • “Girls who overeat as preschoolers are more likely to develop anxiety, impulsivity and hyperactivity when they grow into teenagers, researchers reported in the journal BMC Pediatrics.
    • “The results indicate that children’s eating patterns could be early signs of mental health challenges, researchers said.
    • “Occasional overeating is normal, but if a child frequently overeats, it can be a sign of emotional struggles,” senior researcher Linda Booij, a professor of psychiatry at McGill University in Quebec, Canada, said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “A research team co-led by scientists at Institute for Bioengineering of Catalonia (IBEC) and West China Hospital Sichuan University (WCHSU), working with partners in the U.K., has developed a nanoparticle technology that studies showed can reverse Alzheimer’s disease (AD) in mice. Unlike other types of nanomedicine that rely on nanoparticles as carriers for therapeutic molecules, this approach employs nanoparticles that are bioactive in their own right, and which the team refers to as “supramolecular drugs.”
    • “Instead of targeting neurons directly, the therapy restores proper function of the blood-brain barrier (BBB), the vascular gatekeeper that regulates the brain’s environment. The BBB is a cellular and physiological barrier that separates the brain from the blood flow to protect it from external dangers such as pathogens or toxins. Through their newly reported research the investigators demonstrated that targeting a specific mechanism enables undesirable “waste proteins” produced in the brain to pass through this barrier and be eliminated in the circulation. In Alzheimer’s disease, the main waste protein is amyloid-β (Aβ), the accumulation of which impairs normal neuronal function.
    • “By repairing this critical interface, the researchers observed a significant reduction in brain amyloid-β (Aβ) levels and a reversal of Alzheimer’s pathology in the animal models, with cognitive benefits lasting up to six months following treatment.
    • “Study lead Giuseppe Battaglia, PhD, ICREA research professor at IBEC, principal investigator of the Molecular Bionics Group, and colleagues reported on their findings in Signal Transduction and Targeted Therapy, in a paper titled “Rapid amyloid-β clearance and cognitive recovery through multivalent modulation of blood–brain barrier transport,” in which they stated, “This innovative therapeutic paradigm offers a promising pathway for developing effective clinical interventions, addressing vascular contributions to AD, and ultimately enhancing patient outcomes…The therapeutic trilogy achieved—amyloid clearance, barrier restoration, and sustained cognitive recovery—establishes a blueprint for precision neurovascular medicine.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “It was a repeat performance for all 10 children’s hospitals named as the nation’s best in this year’s iteration of U.S. News & World Report’s ranking.
    • “The highly watched list, now in its 19th year, reviewed outcomes, practices and surveyed opinions for 198 children’s hospitals.
    • “Of these, 86 hospitals were named in some respect, whether that be a top-10 ranking for 10 different pediatric specialties and/or as one of 50 unranked facilities named as a high performer on pediatric and adolescent behavioral health.
    • “Among these, 10 children’s hospitals were named to the list’s honor roll for scoring well across multiple specialties. That unranked collection is identical to last year’s honorees.
      • “Boston Children’s Hospital
      • “Children’s Hospital Colorado, Aurora
      • “Children’s Hospital Los Angeles
      • “Children’s Hospital of Philadelphia
      • “Children’s National Hospital, Washington, D.C.
      • “Cincinnati Children’s
      • “Nationwide Children’s Hospital, Columbus, Ohio
      • “Rady Children’s Hospital, San Diego
      • “Seattle Children’s Hospital
      • “Texas Children’s Hospital, Houston”
  • and
    • “Providers are betting on artificial intelligence to ease the pain point of prior authorization, a new survey shows.
    • “Cohere Health, which provides clinical intelligence to insurers and risk-bearing providers, polled 200 clinicians and office administrators and found that 99% of clinicians report confidence in using AI to back prior authorization. Most (96%) office administrators said the same.
    • “Two-thirds of those surveyed said a completely digital prior authorization process would significantly improve their workflows. Across the board, the respondents said the process should have real-time tracking baked into the experience, allowing them to track the status of key requests.
    • “Providers are speaking loud and clear: they want and deserve a prior authorization process that is smarter, simpler and more transparent,” said Brian Covino, M.D., chief medical officer of Cohere Health, in an announcement.”
  • Healthcare Dive relates,
    • “Saint Peter’s Healthcare System and Atlantic Health abandoned plans to merge on Monday, citing impacts of the “rapidly evolving healthcare landscape nationally.”
    • “The New Jersey-based health systems first announced plans to combine in January last year and signed a definitive agreement to merge in June 2024. 
    • “The systems shared scant details about why the deal fell apart. However, in a joint statement issued Monday both Atlantic President and CEO Saad Ehtisham and Saint Peter’s President and CEO Leslie Hirsch called the deal’s end disappointing.”
  • STAT News informs us,
    • “Just a decade ago, a doctor with multiple medical licenses was an anomaly. Sometimes physicians would apply for credentials from a few states if they lived near a border and wanted the flexibility to practice on either side, since a doctor needs to be licensed where their patient is physically located. In-demand specialists might get a few more if they wanted to see patients virtually. But in the years since Covid began driving patients online, the number of physicians seeking multi-state licensure has ballooned to support the growing field of telehealth.
    • “Within that group, a STAT analysis of physician licenses shows that a small but powerful cohort of physicians is accumulating licenses in all 50 states, plus the nation’s capital and its territories. These physicians don’t max out on licenses just to practice across state lines. Often, they own the medical groups that are affiliated with nationwide telehealth companies. A doctor’s full roster of medical licenses can be leveraged for online businesses that provide specialty care, build patient funnels for pharma companies seeking to sell drugs directly to consumers, prescribe compounded meds — or sometimes, all of the above. 
    • “In 2016, just nine physicians in the U.S. held active licenses in all 50 states, according to data from the Federation of State Medical Boards. By 2024, 172 doctors had filled out their bingo card, and another 356 doctors had acquired at least 45 licenses — significantly outpacing the profession’s overall growth.”
  • As we approach Open Season, the American Diabetes Association offers “Health Insurance Aid for Diabetes. Access to medical care is key to managing your diabetes. Get more information on resources available to people living with diabetes.”

Midweek report

David Ermer–CDC, CMS, Congress, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “Amid tough talk from both sides of the aisle about who’s to blame for the partial government shutdown, bipartisan talks began to take shape as the rank-and-file sought a way out of the impasse.
    • “Various groups of senators were seen huddling on the floor Wednesday during a vote series, even as Democrats again mostly rejected the House-passed stopgap funding bill that would reopen the government through Nov. 21.
    • “The 55-45 margin on the procedural vote was the same tally as the night before, with the same three Democratic caucus members crossing the aisle to support it: Nevada’s Catherine Cortez Masto, Pennsylvania’s John Fetterman and Maine’s Angus King, an independent who caucuses with the party.
    • “That’s two more Democratic caucus members than voted for the measure 10 days ago, which Republicans believe demonstrates fissures in the ranks that will only grow as the shutdown’s impacts build. But it’s five votes short of the 60 needed to overcome a filibuster.”
  • The Wall Street Journal adds,
    • “During a huddle with a bipartisan group of senators on the floor Wednesday, Sen. Ruben Gallego (D., Ariz.) floated the idea of voting to reopen the government with a commitment from Republicans to negotiate on the healthcare subsidies by Nov. 1. Republicans reiterated they didn’t want to negotiate while the government was shut down, according to a person familiar with the conversation.
    • “This is us, just senators randomly getting together and spit balling, and then see if we can get to some kind of consensus,” Gallego said. “And then I think a lot of us would then go back to our leadership and then go from there.”
  • Federal News Network informs us,
    • “After congressional appropriations lapsed and a government shutdown began at midnight on Oct. 1, the Trump administration now warns that further federal employee layoffs are imminent.
    • “It’s unclear which agencies will move forward with potential layoffs, beyond at least one agency — the U.S. Patent and Trademark Office — that on Wednesday issued layoff notices. Vice President JD Vance doubled down on the Office of Management and Budget’s last week’s directive to terminate more federal employees in the case of a government shutdown.
    • “If this thing drags on for another few days, or, God forbid, another few weeks, we are going to have to lay people off,” Vance told reporters during a White House press conference Wednesday afternoon. “We’re going to have to save money in some places so that essential services don’t get turned off in other places.”
    • “OMB Director Russell Vought took a more immediate stance on how quickly he expected RIFs to take place. In a private call with House Republicans on Wednesday, Vought said agency RIFs would begin “in a day or two,” according to reporting from Politico.”
  • Fierce Healthcare offers a look at the major insurers’ 2026 Medicare Advantage plans and adds,
    • “On day one of the government shutdown, the Centers for Medicare and Medicaid Services (CMS) sent out a Medicare Learning Network Connects Newsletter offering guidance on Medicare billing and telehealth services during the lapse in appropriations. 
    • “CMS reaffirmed in the guidance that pandemic-era expanded telehealth flexibilities have ended for Medicare beneficiaries. Per standard course of action, CMS has directed Medicare Administrative Contractors (MACs) to implement temporary claims hold for 10 business days on telehealth claims. 
    • “Assuming the hold starts Oct. 1, claims will begin to be processed on Oct. 15. The guidance says that providers can still submit claims during the temporary hold, but they will not receive payment. 
    • “The claims hold is meant to avoid the reprocessing of claims in the event that Congress re-ups the flexibilities.” 
  • The White House posted a fact sheet about “the first agreement with a major pharmaceutical company, Pfizer, to bring American drug prices in line with the lowest paid by other developed nations (known as the most-favored-nation, or MFN, price).”
  • The Wall Street Journal explains “How Trump’s Drug-Buying Site ‘TrumpRx’ Will Work. If you are among the 90% of Americans who have health insurance, it’s unlikely to save you much money.”
    • “President Trump announced a deal with Pfizer to sell drugs at reduced prices via TrumpRx.gov and to Medicaid at Most Favored Nation prices.
    • “TrumpRx.gov, launching in early 2026, will offer Pfizer drugs, including Eucrisa and Xeljanz, with average savings of 50%.
    • “The initiative primarily benefits the 27 million uninsured Americans, as 90% with insurance likely save more using their plans.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Children and teenagers are twice as likely to develop long Covid after a second coronavirus infection as after an initial infection, a large new study has found.
    • “The study, of nearly a half-million people under 21, published Tuesday in Lancet Infectious Diseases, provides evidence that Covid reinfections can increase the risk of long-term health consequences and contradicts the idea that being infected a second time might lead to a milder outcome, medical experts said.
    • “Dr. Laura Malone, director of the Pediatric Post-Covid-19 Rehabilitation Clinic at Kennedy Krieger Institute in Baltimore, who was not involved in the study, said the findings echo the experience of patients in her clinic.
    • “Just because you got through your first infection and didn’t develop long Covid, it’s not that you are completely out of the woods,” she said.”
  • STAT News tells us “Leucovorin has a place in autism treatment, researcher says, but he tamps down parents’ expectations. ‘I haven’t seen a remarkable response,’ says Robert Hendron, who studied its use in kids with ASD.”
  • The Washington Post calls attention to “what you should know before buying folate and folinic acid supplements. Medical experts warn against treating over-the-counter supplements the same as leucovorin, the drug the Trump administration has touted as an autism treatment.”
  • Cigna, writing in LinkedIn, discusses the unique health needs of women.
  • Medscape lets us know that “A prospective cohort study found that a high intake of ultraprocessed foods (UPFs) was associated with an increased risk for overall colorectal cancer (CRC) and right-sided colon cancer.”
  • The Washington Post relates,
    • “Walmart will stop using synthetic dyes and certain preservatives, artificial sweeteners and fat substitutes in its private-label offerings, adding the world’s largest retailer to the growing contingent of brands moving to banish food additives amid questions about their health risks.
    • “The announcement Wednesday comes as consumers are pressing for healthier options, and as state and federal officials crack down on the use of petroleum-based dyes in cereals, condiments and a variety of other foods. Health and Human Services Secretary Robert F. Kennedy Jr. — who has likened such additives to “poisonous compounds” — said in April that the administration had reached an “understanding” with the food industry to phase out several colorings over the next few years. General Mills, Kraft Heinz and other foodmakers have since issued statements to that effect.”
    • “Walmart said it will excise nearly 30 additives from its private-label food portfolio by January 2027, including its Great Value, Freshness Guaranteed, Bettergoods and Marketside brands.”
  • Medscape points out what scientists are learning about laser tattoo removal.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit is betting on ambulatory care expansion to shore up operations and putting hospital deals on ice.
    • “The Chicago-based system has added 90 ambulatory care sites to its footprint in its last two fiscal years, 34 of which opened across nine states in fiscal 2025, which ended June 30.
    • “At this point, we’re not focused on hospital acquisitions. We’re primarily looking at ambulatory growth to meet the needs of our consumers,” said CommonSpirit CEO Wright Lassiter III on a Wednesday earnings call. “We are very intentional about where we’re headed and what we believe we need to do to create the kind of success we want as a ministry.”
  • and
    • “Health insurance companies and health systems are familiar with heated contract battles, but the scramble to lock down favorable terms is rising.
    • “Hospitals, under pressure to operate within tight margins, are wrestling with the financial ramifications of looming federal healthcare cuts and coping with sustained labor shortages Insurers seek to clamp down on rising utilization and appease dissatisfied investors.
    • “Those dynamics have fostered an environment that’s led to more messy public contract fights than usual. “We’ve just never seen anything like it,” said Brandon Edwards, CEO of Unlock Health, a marketing agency for providers.
    • “There were 79 confirmed contract disputes between insurers and providers this year as of Sept. 1, according to an FTI Consulting analysis of publicly reported negotiations. Half related to Medicare Advantage, and 20% were unresolved at the beginning of September. The trend has been rising since last year, the analysis shows.”
  • Per Fierce Healthcare,
    • “General Catalyst’s Health Assurance Transformation Company (HATCo) has wrapped its acquisition of Summa Health, shifting the Akron, Ohio-based healthcare system from a nonprofit to a taxed subsidiary.
    • “The deal was first announced in early 2024 and underwent a lengthy regulatory review amid pushback from local residents. Ohio Attorney General Dave Yost gave the transaction a green light during the summer with certain conditions, including an increase in the sale price from $485 million to $500 million.
    • “Today is the culmination of months of collaboration between our organizations and marks the start of a new chapter for Summa Health and those we serve,” Cliff Deveny, M.D., Summa Health President and CEO, said in Wednesday morning’s announcement. “With HATCo, we can preserve our community roots, invest in our team and take bold steps to modernize and expand access to ensure Summa remains strong for decades to come.”
    • “Summa Health is among Ohio’s larger health systems. It employs more than 8,500 people across two acute care hospital campuses, 15 community medical centers, a rehab hospital, a health insurance arm, a multispecialty group practice and a research and medical education program. It reported about $2 billion in total revenue, but a narrow operating loss of $8 million in fiscal year 2024.”
  • and
    • “With $10 billion earmarked to grow its U.S. operations through 2035, AbbVie continues to lay out the particulars on its decade-long domestic investment strategy.
    • “The Chicago-area Big Pharma has kicked off work on a $70 million expansion of its bioresearch center in Worcester, Massachusetts, where the company conducts both manufacturing and R&D for biologic medicines.
    • “The project, which falls under the banner of AbbVie’s broader U.S. investment announced in April, will beef up capacity at the Worcester site that AbbVie plans to use for local production of current and upcoming drugs in cancer and immunology, according to a Sept. 30 press release.
    • “AbbVie is specifically building out additional biologics manufacturing areas at the site, as well as a new three-story building that will contain a laboratory, warehouse and office space. The company said it expects the project to hasten the production transfer of certain oncology meds from Europe to the U.S.”
  • The Wall Street Journal notes,
    • “Patients are increasingly managing their own healthcare due to doctor shortages and chronic diseases.
    • “Direct-to-consumer lab tests are expanding, with Quest Diagnostics, for instance, offering more than 150 tests.
    • “AI chatbots and wearable devices are emerging tools, but concerns exist regarding data privacy, misinformation and clinical validation.”

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The federal government was on course to shut down early Wednesday, as hopes of any last-minute deal evaporated and both Republicans and Democrats appeared content to trigger the first lapse in funding since President Trump’s first term.”
  • The Senate voted 55-45 on accepting the House Continuing Resolution this evening. A 60 vote in favor was required due to cloture rules. Three Democrats voted in favor and Sen. Rand Paul voted against due to his disdain for continuing resolutions. Roll discusses the vote and next steps in Congress.
  • Govexec adds,
    • “The Trump administration is planning to furlough around 550,000 federal employees on Wednesday if Congress fails to act before government funding expires late Tuesday evening, representing an unusually low less than one-quarter of the workforce. 
    • “The White House is also vowing to oversee large-scale layoffs if a government shutdown occurs, though that would play out through a separate process than the one that sends home certain employees only until funding is restored. In the last 15 years, administrations have typically prepared to furlough between 35% and 40% of the federal workforce.”
  • Federal News Network shares agency shutdown contingency plans.
  • OPM Director Scott Kupor writes in his blog about how he spent days leading to the end of federal fiscal year.
  • The NBC station in Washington, DC, reminds us,
    • “Tens of thousands of government workers are preparing to leave the federal workforce Tuesday, the final day for many who took the government’s “Fork in the Road” resignation offer earlier this year.
    • “Among those are as many as 60,000 retirees who will now anxiously wait for their federal retirement benefits to kick in – a process that could take months and is potentially impacted by the looming government shutdown.
    • “There’s no question there’s going to be a surge. We’re doing everything we can to try and address it,” Office of Personnel Management (OPM) Director Scott Kupor told the News4 I-Team. * * *
    • “Even though OPM knew months ago thousands of employees were leaving, he said their retirements can’t start processing until after they’re off the federal payroll. That’s because each department in the federal government has to wait for an employee’s final paycheck before finalizing their application and sending it to OPM.
    • “Now look, it sounds crazy to me, as well,” he told the I-Team. “And so, one of the things we’re looking at is we’re trying to just basically redesign the entire process from start to finish.”
  • The Wall Street Journal lets us know,
    • “President Trump unveiled plans Tuesday to launch a government-run website, dubbed TrumpRx, for consumers to buy drugs directly from manufacturers, and he said Pfizer plans to offer some of its drugs on the site at a reduced rate.
    • “Separately, Trump said Pfizer would offer all of its drugs to Medicaid at a reduced, “most favored nation” price, as well as introduce any new drugs to the U.S. market at the reduced prices. In return, the company gains a three-year grace period to exempt it from national-security-related tariffs, as long as the company invests in domestic manufacturing, the company said.
    • “The American consumers have been subsidizing research-and-development costs for the entire planet,” Trump said in the Oval Office, flanked by top health officials and Pfizer Chief Executive Albert Bourla.” * * *
    • “Pfizer also announced a $70 billion investment on research and development and manufacturing medications in the U.S.”
  • Per a Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) released final guidance for the third cycle of negotiations under the Medicare Drug Price Negotiation Program (Negotiation Program). This final guidance incorporates significant policy refinements based on public feedback, with a particular focus on increasing transparency, and implements expanded protections for orphan drugs enacted in the Working Families Tax Cuts Act (Public Law 119-21).” * * *
    • “[The] final guidance addresses how drugs payable under Medicare Part B will be eligible for negotiation, requirements and process for renegotiation.”
    • “The Fact Sheet for the Final Guidance for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028 is available at: https://www.cms.gov/files/document/ipay-2028-final-guidance-fact-sheet.pdf.
    • “Additional information about the Medicare Drug Price Negotiation Program can be found at: https://www.cms.gov/priorities/medicare-prescription-drug-affordability/overview/medicare-drug-price-negotiation-program.” 
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services’ (HHS) Administration for Community Living (ACL) today announced $60 million in new grant awards to states, territories, tribes, and local organizations supporting older adults and Americans with disabilities. These awards will strengthen existing programs that protect health, preserve independence, and support caregivers — key priorities of the Make America Healthy Again agenda.”
  • Per a National Institutes of Health news releases,
    • Anthony Letai, MD, Ph.D., was sworn in [yesterday September 29, 2025] as director of the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), by Health and Human Services Secretary Robert F. Kennedy, Jr.
    • Dr. Letai takes the helm of the world’s most prestigious cancer research agency after serving as professor of medicine at Harvard Medical School and medical oncologist at the Dana-Farber Cancer Institute. He possesses decades of experience studying cell death in cancer, developing treatments, and identifying predictive biomarkers.
  • and
    • “The U.S. Department of Health and Human Services today announced a doubling of funding for its Childhood Cancer Data Initiative (CCDI) at the National Institutes of Health (NIH). The funding surge is designed to accelerate the development of improved diagnostics, treatments, and prevention strategies.
    • “President Trump in 2019 established the CCDI to collect, generate, and analyze childhood cancer data. Its budget will rise from $50 million to $100 million, giving the federal government stronger data for this effort. The initiative will also bring in private-sector partners to apply advanced artificial intelligence to speed up cures for pediatric cancer.
    • “Health and Human Services Secretary Robert F. Kennedy, Jr., NIH Director Jay Bhattacharya, and National Cancer Institute (NCI) Director Anthony Letai joined President Trump at the White House today to discuss their commitment to eradicating childhood cancer and to mark the signing of the president’s executive order, Unlocking Cures for Pediatric Cancer with Artificial Intelligence.“

From the Food and Drug Administration front,

  • FDA Director Marty Makary, MD, announced today,
    • “As part of the FDA’s broader strategy to combat the crisis of youth vaping, we are launching an initiative to increase voluntary compliance from retailers—including vape shops, convenience stores and gas stations—that play a key role in the distribution of both legal and illegal products into American communities.” * * *
    • “We have received questions from retailers about which tobacco products are legal to sell, so we’re mailing materials to more than 300,000 retailers nationwide containing: 
      • “A list of the 39 vapes and 20 nicotine pouch products that can be legally marketed in the United States, which features QR codes linked to the FDA real-time digital versions of these lists (www.fda.gov/authorizedecigs and www.fda.gov/authorizednicotinepouches); 
      • “Information on accessing FDA’s new Searchable Tobacco Product Database, a database of over 17,000 tobacco products—covering all categories, such as cigarettes, cigars, hookah, and e-cigarettes—that may be legally marketed in the United States; and  
      • “New tobacco retailer education materials, including a wall calendar of reminders focused on retailer requirements such as only selling tobacco products to those 21 and older and requiring a photo ID check of anyone under 30.” * * *
    • “Mailings will begin this fall. Retailers looking to order additional free materials—including a digital age verification calendar—can do so via FDA’s Tobacco Education Resource Library.”  
  • The American Hospital Association News tells us,
    • “The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial intelligence-enabled medical device performance in real-world applications. This includes approaches to detect, assess and mitigate performance changes over time to help assure the devices remain safe and effective throughout their life cycle. The FDA is accepting comments at www.regulations.gov until Dec. 1. The notice follows a request by the Office of Science and Technology Policy issued Sept. 26 that seeks feedback on federal regulations that hinder AI development, deployment or adoption.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has expanded its early alert communication initiative to cover potentially high-risk removals or corrections for all medical devices, the agency said Monday.
    • “Officials announced a pilot of the initiative late last year. Since then, the agency has issued early alerts shortly after companies have told customers about issues with certain medical devices. 
    • “The FDA said the pilot was successful, leading it to expand the program beyond the initial five therapeutic areas and include potentially high-risk safety events of all medical devices.”
  • BioPharma Dive points out five FDA decision to watch for in the fourth quarter of 2025. “The agency is set to decide by the end of the year whether to approve an obesity pill, a new kind of kidney disease drug and a long-awaited heart medicine.

From the public health and medical / Rx research front,

  • STAT News interviews “Lilly’s head scientist [about] its GLP-1 pill, Alzheimer’s strategy, and finding promising ideas and startups. CSO Daniel Skovronsky’s long-term vision: ‘We’re trying to invest in the babies’” 
  • Biopharma Dive reports,
    • “Metsera’s top obesity drug succeeded in a Phase 2 trial, helping enrollees treated with the highest dose lose an average of 14 percentage points more of their body weight than placebo recipients after 28 weeks, the company said Monday.
    • “Interim results from a separate trial also showed that a step-up, or “titrated,” dosing regimen limited the kind of gastrointestinal side effects that often lead people to stop taking GLP-1 drugs for obesity. That finding suggested Metsera’s drug, MET-097i, could have a tolerability profile “better than tirzepatide,” which Eli Lilly sells as Zepbound for weight loss, wrote Leerink Partners analyst David Risinger in a Tuesday client note.
    • “The announcement comes one week after Pfizer reached a deal to acquire Metsera for $4.9 billion. The buyout puts Pfizer back in the chase to develop obesity drugs, a market that could be worth more than $100 billion a year in sales by the next decade.”
  • Per Fierce Pharma,
    • “Two clinical trials of Merck’s pulmonary arterial hypertension (PAH) drug Winrevair were so conclusive that the studies were halted within the last year because the efficacy of the treatment was assured.
    • “Tuesday, Merck reported results from the phase 3 Hyperion study, which showed that Winrevair, when combined with background therapy, achieved its primary endpoint by reducing the risk of clinical worsening events by 76% compared with placebo in recently diagnosed adults.”
  • Per MedPage Today,
    • “Gabapentin prescribing rose sharply in recent years, with the generic drug becoming the fifth most dispensed product in retail pharmacies in 2024, a CDC analysis showed.
    • “From 2010 to 2024, prescriptions jumped from 79.5 to 177.6 per 1,000 people, according to Gery Guy Jr., PhD, of the CDC National Center for Injury Prevention and Control, and co-authors.
    • “The number of persons who received gabapentin soared from 5.8 million in 2010 to 15.5 million in 2024, Guy and colleagues reported in Annals of Internal Medicine. That represented an increase from 18.9 per 1,000 people in 2010 to 46.9 per 1,000 people in 2024.” * * *
    • “Gabapentin is approved for seizures and postherpetic neuralgia; gabapentin enacarbil is approved for restless legs syndrome. Despite limited indications, gabapentin and its cousin pregabalin are widely prescribed off-label for various other pain syndromes.
    • “Common side effects of gabapentin include drowsiness, dizziness, blurry or double vision, and difficulty with coordination and concentration. In 2019, the FDA warned about serious breathing problems that may occur in patients using gabapentin or pregabalin who have respiratory risk factors. These factors included taking opioids or other drugs that depress the central nervous system, conditions like chronic obstructive pulmonary disease that reduce lung function, and older age.”
  • Per Health Day,
    • “An invisible storm might rage for years inside the bodies of people at risk for rheumatoid arthritis, prior to any joint pain occurring, a new study says.
    • “These folks experience dramatic immune system changes long before they feel symptoms, researchers reported in the journal Science Translational Medicine.
    • “Overall, we hope this study raises awareness that rheumatoid arthritis begins much earlier than previously thought and that it enables researchers to make data-driven decisions on strategies to disrupt disease development,” senior researcher Mark Gillespie, an assistant investigator at the Allen Institute in Seattle, said in a news release.”
  • Pulmonary Advisory informs us, “Asthma risk in women has significant associations with body mass index (BMI), body roundness index (BRI), and white blood cell count (WBC), according to study findings published in BMC Pulmonary Medicine.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cardinal Health CAH is building a flagship pharmaceutical distribution center in Indianapolis to keep up with its growing customer base and the shifting needs of drug companies.
    • “The planned 230,000 square-foot plant is the healthcare company’s latest step in a 10-year plan to modernize and expand its distribution network. Pharmaceutical distribution remains Cardinal’s most lucrative business, and it is continuing to gain customers. The Dublin, Ohio, company added more than $10 billion of new business in the last fiscal year, said Debbie Weitzman, chief executive of Cardinal’s pharmaceutical and specialty solutions business.
    • “That comes with it a lot of volume that we need to be prepared for,” she said.”
  • Fierce Healthcare relates,
    • “Millie, a California-based hybrid women’s health clinic, is expanding its offerings with perimenopause and menopause care.
    • “The offering, available in person and virtually, includes hormone therapy, nonhormonal treatments, vaginal treatments and lifestyle strategies. Millie currently has two clinics in the Bay Area.
    • “The company, which launched in 2022, was originally focused on maternity care. Staffed with nurse-midwives and doulas, Millie provides care for low-risk pregnancies out of its clinic. Millie also partners with hospitals, where its providers support labor and deliver babies. Midwives drive lower caesarean section rates and higher patient satisfaction scores and can help fill crucial gaps in obstetrics care. As of 2024, more than a third of U.S. counties were designated maternity care deserts. 
    • “In 2023, Millie introduced preconception counseling and gynecology offerings, recognizing that optimizing these areas of health can support better maternal and overall health outcomes. It has now further expanded its continuum of care with menopause care, since many of its patients are becoming parents in their late 30s and navigating postpartum and perimenopause at the same time.” 
  • Beckers Hospital Review shares “the days cash on hand at 40 health systems as of June 30, according to their most recent financial reports.”
  • Beckers Payer Issues offers eight things to know about catastrophic health claims.