Tuesday report

Medicare

Tuesday report

David Ermer–CDC, CMS, Electronic health records, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “Federal employees will be able to contribute more to their Thrift Savings Plan accounts next year. The IRS increased the maximum annual contribution limit to $24,500, which is a $1,000 increase over 2025. Additionally, employees aged 50 or older can save more money through their catch-up contributions. And if employees are aged 60 to 63, they can save even more with a higher catch-up contribution of $11,250. (IRS increases annual TSP savings limit for 2026 – IRS)”
  • The Wall Street Journal tells us,
    • “Calley Means, a confidant to health secretary Robert F. Kennedy Jr., is taking a permanent post in the Trump administration, where he is expected to serve as a bridge between the Make America Healthy Again movement and President Trump’s broader MAGA coalition.
    • “Means, who earlier this year served in a temporary role at the White House, has been tapped to be a senior adviser in Kennedy’s Department of Health and Human Services, charged with helping to ensure the success of the MAHA movement’s policy goals, according to people familiar with the matter.
    • “As of Tuesday, Means was listed in the department’s personnel directory—which is public—as a senior adviser in the office of Assistant Secretary for Health Brian Christine.”
  • Per an AHIP news release,
    • “Health plans contribute to the health and economic stability of communities throughout America. A new comprehensive report from AHIP offers a detailed state-by-state view of health coverage and underscores the indispensable role of health plans in communities nationwide. 
    • “Health plans support the health and well-being of Americans in all 50 states by delivering high-quality coverage and doing everything they can to shield consumers from the rising cost of care,” said Mike Tuffin, AHIP’s President and CEO.
  • The American Hospital Association News notes,
    • “The AHA and the Federation of American Hospitals Nov. 18 released a study conducted by Dobson | DaVanzo, underscoring the threat to patient care by expanding physician-owned hospitals in rural communities. The study found that if a new POH opens in the same market as a full-service rural hospital, the full-service hospital’s financial stability would be negatively affected as the POH would siphon off healthier and commercially insured patients, risking access to care and community jobs. 
    • “Full-service hospitals across the country are struggling, and rural hospitals are particularly vulnerable to headwinds. … Removing restrictions on POHs, which are notorious for selectively picking the healthiest and wealthiest patients and allowing them to open near full-service rural hospitals will jeopardize access to 24/7 care in rural America,” write Don May, FAH executive vice president of policy, and Ashley Thompson, AHA senior vice president of public policy analysis and development, in an accompanying blog.” 
  • The Centers for Medicare and Medicaid Services released today a new edition of the Section 111 user guide for group health plans, which term includes FEHB and PSHB plans.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved a new medication for a rare genetic condition in a decision that represents a long-awaited milestone for the drug’s developer, biotechnology company Arrowhead Pharmaceuticals. 
    • “The agency on Tuesday cleared the therapy, Redemplo, for familial chylomicronemia syndrome, or FCS, a rare condition that disrupts the body’s ability to break down fats in the bloodstream. It’s been specifically approved for use alongside a diet to help reduce levels of those fats, or triglycerides, in adults with FCS. The drug is self-administered via a subcutaneous injection once every three months.” 

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Health officials on Monday linked for the first time the measles outbreak that began in Texas with another in Utah and Arizona, a finding that could end America’s status as a nation that has eliminated measles.
    • “The news came in a phone call, a recording of which was obtained by The New York Times, among officials from the Centers for Disease Control and Prevention and state health departments.
    • “The chain of transmission began in January, in a conservative Mennonite group on the western edge of Texas and spread to Oklahoma and New Mexico.
    • “Countries lose their elimination status after 12 months of sustained transmission. If the outbreak cannot be extinguished by January, the anniversary of the first cases in Texas, the United States will lose what is known as “elimination status” as determined by the World Health Organization, which it has had for 25 years.”
  • Beckers Hospital Review informs us,
    • “Influenza activity remains low but is increasing across the U.S., according to the CDC’s latest FluView report. 
    • “The agency updated data on flu trends Nov. 14, offering the first national snapshot of respiratory virus activity since September. The update follows a nearly two-month blackout in national reporting, during which states had to pause dashboard updates or rely on internal data amid the federal government shutdown.
    • “Less than 1% of ED visits were flu-related, a figure that remained relatively stable compared to the previous week. However, flu-related ED visits are rising among children. The virus accounted for about 1% of visits among children 4 and younger, and 1.3% among those ages 5-17. 
    • “Nationally, 1,665 patients with laboratory-confirmed influenza were admitted to the hospital, up slightly from the previous week. Overall, flu activity remains low, with all states reporting “minimal” or “low” activity. 
  • NBC relates,
    • “While the average age for being diagnosed with heart disease in the United States is typically in the mid-60s for men and early 70s for women, the factors, such as high blood pressure, diabetes and bad cholesterol levels, can start years, sometimes decades, earlier. 
    • “A new online heart risk calculator could help younger adults learn whether they’re likely to develop heart disease, as much as 30 years in the future, according to a study published in the Journal of the American College of Cardiology on Monday. That’s a significantly longer time period compared with traditional screenings, including the Framingham risk calculator or the ASCVD Risk Estimator Plus, which measure a 10-year risk for people ages 40 and older. 
    • “This tool was motivated by helping younger adults understand their long-term risk for heart disease,” said senior study author Sadiya Khan, the Magerstadt professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine. “We all procrastinate, but prioritizing health has to start today — and can with this tool.”
  • Per CNN Health,
    • “Starting prenatal care after the first trimester of pregnancy appears to be a growing yet dangerous trend in the United States, according to a new report.
    • “The report, released Monday by the infant and maternal health nonprofit March of Dimes, says that only about 75% of babies last year were born to mothers who started prenatal care in the first trimester of pregnancy.
    • “We’ve always known that getting that prenatal care started early is important,” said Dr. Michael Warren, March of Dimes’ chief medical and health officer. He added that now, in the United States, it’s moving in the “wrong direction.” * * *
    • “The new March of Dimes report gives the United States a D+ grade for having a preterm birth rate of 10.4% for the third year in a row.
    • “Sadly, I actually have to say that there was nothing that surprised us” in the new report, said Divya Sooryakumar, the vice president of programs and impact of the maternal health nonprofit Every Mother Counts, who was not involved in the report.”
  • BioPharma Dive points out,
    • “With new, positive data in hand, Merck & Co. plans to move its cardiovascular drug Winrevair into late-stage testing as a treatment for a condition often caused, at least in part, by high blood pressure.
    • “This condition — known as heart failure with preserved ejection fraction, or “HFpEF” — is common, affecting more than half of the roughly 6.7 million people in the U.S. believed to be living with heart failure. In these people, the heart’s main pumping chamber stiffens over time due to a variety of possible factors, including age, obesity and hypertension. While the chamber still pumps a “normal” amount of blood, patients with HFpEF can experience fatigue, shortness of breath, as well as life-threatening health complications.”
    • “The Food and Drug Administration has already approved several medicines for HFpEF, among them AstraZeneca’s Farxiga, Novartis’ Entresto, and Eli Lilly and Boehringer Ingelheim’s Jardiance. Merck has been trying to expand that list with Winrevair, a first-of-its-kind therapy that works by regulating signals from “activin” proteins that spur cell growth and division. In heart failure, the over-production of certain cells, molecules and proteins can harden the organ and impair its function.
    • “On Tuesday, Merck announced Winrevair had hit the main goal of a mid-stage clinical trial that enrolled 164 adults with high blood pressure in their pulmonary arteries caused by HFpEF.” 
  • and
    • “An experimental pill from Roche succeeded in a Phase 3 trial in early-stage breast cancer, helping prevent recurrence for longer than standard hormone therapies when administered after surgery in people with a common form of the disease.
    • “Roche didn’t provide specifics, but said that its drug, known as giredestrant, successfully extended disease-free survival compared to hormone therapy in people with ER-positive, HER2-negative breast cancer following surgical removal of a tumor. A “clear positive trend” was also observed on survival, though Roche said it’s too early to tell whether treatment clearly extended lives. 
    • “Giredestrant is part of a new class of oral “selective estrogen receptor degraders,” or SERDs, that aim to supplant a decades-old injectable therapy. So far, these drugs have largely only proven helpful for a particular subset of patients with advanced disease. Roche’s medicine is the first so far to show a benefit in the “adjuvant” setting, though others are also in late-stage testing.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Former Food and Drug Administration Commissioner Scott Gottlieb, M.D., is joining the board at industry giant UnitedHealth Group.
    • “The company announced the move Tuesday, with CEO and Board Chair Stephen Hemsley saying Gottlieb’s “exceptional healthcare career in both the public and private sectors” will bring valuable insight to the company.
    • “He is an innovator who constantly advocates for a more integrated healthcare approach supported by the latest technology,” Hemsley said. “We welcome his deep expertise and thought leadership as we strive to help people live healthier lives and make the health system work better for everyone.”
    • “Gottlieb served as the FDA Commissioner from 2017 to 2019, and during his tenure, he focused on transparency, patient safety and promoting competition. He took on the opioid epidemic and youth tobacco use during his time at the agency.”
  • Healthcare Dive adds,
    • “Optum Health, the care delivery arm of UnitedHealth, has tapped Krista Nelson as its new CEO effective immediately. Nelson announced the C-suite reshuffling via LinkedIn last week. 
    • “The executive has worked for UnitedHealthcare, UnitedHealth’s payer arm, off and on since 2009, according to her LinkedIn. Nelson was last responsible for overseeing the growth of government programs before switching over to UnitedHealth’s health services division Optum
      in May, when she was tapped as COO of Optum Health.
    • “Now, Nelson replaces Dr. Patrick Conway as the chief executive of Optum Health. Conway has been CEO of Optum since May and CEO of Optum Health since June.
    • “Conway will remain in his post as CEO of Optum following the reshuffling, according to his LinkedIn.”
  • Per Fierce Healthcare,
    • “Cigna Healthcare has unveiled Clearity, a new, copayment-only health plan designed to promote transparency and predictability.
    • “The new plan leans on Cigna’s in-house suite of artificial intelligence tools to make it easier for enrollees to make decisions for their care by arming them with critical information such as upfront pricing and verified patient reviews within a simple digital experience.
    • “The plan features a tiered copay model that does away with deductibles and coinsurance, Cigna said. Employers that select Clearity as an option can choose from five different packages with different cost-sharing options that don’t require narrowing networks or restricting access.
    • “Each package includes four in-network tiers and one out-of-network tier, according to the announcement.”
  • and
    • “Employers expect to see health benefits rise by 6.7% in 2026, reaching more than $18,500 per employee on average, according to a new report.
    • “Analysts at Mercer estimate that health costs in 2025 reached an average of $17,496 for each employee, growth of 6%. That’s a rate that outpaced inflation and wage growth, according to the report.
    • “The increase was driven by a sharp spike in prescription drug spending, which increased by 9.4% on average for large employers, or firms with at least 500 employees. Within that, large employers were more likely to cover GLP-1 drugs for weight loss this year, with 49% offering coverage compared to 44% in 2024.”
  • Per Fierce Pharma,
    • “Only days after revealing an unsolicited buyout bid from Lundbeck, Avadel—which has already signed an agreement to sell itself to Alkermes—has officially determined that the Lundbeck offer is sweeter.
    • “After “discussions and negotiations” with Lundbeck and separate consultations with its advisors, Avadel on Monday confirmed that it views the Lundbeck deal as a “superior company proposal.”
    • “The distinction is important because under Avadel’s existing transaction agreement with Alkermes, the latter company now has five business days to “discuss or negotiate in good faith” any potential amendments to its prior offer. Back in October, the companies got together on a $2.1 billion buyout agreement.
    • “Avadel says Lundbeck’s offer is worth up to $2.4 billion. The proposal features a $21-per-share upfront payment plus a contingent value right worth up to $2 per share based on future sales performance of Avadel’s narcolepsy drug Lumryz and pipeline candidate valiloxybate.”
  • Beckers Hospital Review lets us know,
    • “Novo Nordisk is temporarily offering doses of Type 2 diabetes drug Ozempic and weight loss medication Wegovy for $199, the drugmaker said Nov. 17. 
    • “Between Nov. 17 and March 31, self-paying patients of Wegovy or Ozempic can order their first two months’ worth of the medications for $199 per month, Novo Nordisk said. The discount applies to the two lowest doses, 0.25 and 0.5 milligrams, which are the recommended dosages for the first two months. 
    • “Following the first two months of treatment, self-paying patients will be eligible to order Wegovy or Ozempic for $349 per month. On Nov. 6, Novo Nordisk and the U.S. government reached a pricing agreement to sell Ozempic and Wegovy for $245 through Medicare and Medicaid, with a $50 copay for patients. The monthly prices will be $350 through TrumpRx, a direct-to-consumer website set to launch in early 2026. 
    • “GoodRx, Costco, WeightWatchers, CVS and other pharmaceutical retailers will participate in the offering.” 
  • The Wall Street Journal adds,
    • “The trillion-dollar club has become crowded with mostly tech names riding the AI boom. Eli Lilly LLY might soon join them for a far different reason: the weight-loss bonanza.
    • “Crucially, Lilly’s trajectory doesn’t hinge on artificial-intelligence sentiment or cloud-spending cycles that investors are suddenly questioning. In fact, it could even benefit from an investor rotation away from technology into other sectors. Its staying power above a $1 trillion market value will come down to two questions: how quickly it can expand the obesity-drug market and how completely it can dominate it. 
    • “On both fronts, its future looks promising. This year, Lilly has moved sharply ahead, securing Medicare access while widening its lead over Wegovy maker Novo Nordisk NOVO.B. That is why investors shouldn’t assume the rally stops at a trillion. 
    • “The key thing to remember is that—much like the AI boom—the GLP-1 surge is still in its infancy. Lilly only began selling its weight-loss drug Zepbound in late 2023, and the Food and Drug Administration only declared an end to a supply shortage of obesity drugs last year. As production has scaled up and new clinical data has emerged, Zepbound has pulled ahead of Wegovy. Despite Zepbound’s later launch, Lilly now captures a clear majority of new obesity-drug prescriptions, a sharp shift in market dynamics.”
  • Per Beckers Payer Issues,
    • “Medica plans to purchase certain contracts and assets from UCare as the latter’s legacy business winds down operations next year, the two companies said Nov. 17.
    • “We have the opportunity to build upon both Medica’s strengths and UCare’s legacy, allowing Minnesotans to continue to have a health care experience that ensures they feel cared for,” Medica CEO Lisa Erickson said.
    • “The agreement encompasses UCare’s Medicaid and ACA businesses that cover more than 300,000 Minnesotans. The transaction is expected to wrap during the first quarter of 2026. Individuals in UCare’s 2026 Medicaid and individual and family plans will still receive services without interruption.”
  • Per MedTech Dive,
    • “Medtronic’s pulsed field ablation business took off last quarter as competition in the space continues to heat up nearly two years after products first launched.
    • “PFA sales grew by more than 300% year over year in the U.S. and outside the U.S. in the second quarter of Medtronic’s fiscal 2026, according to materials released ahead of Tuesday’s earnings call. The company did not report specific sales figures.
    • “The technology fueled growth for the company’s overall cardiac ablation solutions business, or CAS, where sales increased by 71% year over year organically in the fiscal second quarter. Medtronic’s CAS business is steadily climbing as PFA adoption continues: The unit’s sales grew by nearly 50% and 30% in the company’s previous two fiscal quarters.”

From the artificial intelligence and electronic health records front,

  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a new $2 million Caregiver Artificial Intelligence Prize Competition to support the 1 in 4 Americans serving as caregivers for older adults and people with disabilities.
    • “This initiative through HHS’ Administration for Community Living (ACL) recognizes the millions of caregivers who support aging relatives and loved ones with disabilities. Their compassion and commitment form the backbone of America’s long-term care system, helping older adults and people with disabilities live with dignity and independence at home and in their communities.” * * *
    • “For updates on the competition, visit ACL’s Caregiver AI Prize Competition page.”
  • Fierce Healthcare reports,
    • “Aetna is rolling out a new artificial-intelligence-powered, conversational tool designed to make it easier for members to understand and navigate their health and benefits.
    • “The AI assistant is embedded in the insurer’s website and member app to readily answer questions that they may have about benefits and coverage, with session awareness that makes the experience feel less like a traditional chatbot. And members do not need to use healthcare jargon to secure answers, according to the company.
    • “For example, a member is told by their doctor that they need surgery. They can ask the assistant about their coverage for the procedure and receive a full and personalized breakdown of their costs and options, including estimates for fees and copayments.”
  • Healthcare Dive relates,
    • “Humana and Epic are partnering to speed patient appointment check-in and coverage verification for Medicare Advantage beneficiaries, the companies said Tuesday. 
    • “The new features are included in the electronic health record vendor’s payer platform, which allows insurance details from Humana to be automatically shared with providers before patients arrive at appointments, according to a press release. 
    • “The collaboration is an early result of an initiative from the Trump administration that aims to boost health data sharing and reduce repetitive, paper-based processes in healthcare, the companies said.” 
  • Beckers Health IT tells us,
    • “Oakland, Calif.-based Kaiser Permanente recently completed one of the largest EHR consolidations in healthcare history, migrating about 40 million patient records.
    • “In early 2025, the 40-hospital system merged 12 instances of its Epic EHR into two: in its Northern California and Southern California markets. In each case, the health system transferred roughly 20 million patient records with less than three hours of downtime and no canceled appointments or delayed procedures.”
    • The article also features a Beckers interview with “Neil Cowles, chief information and technology officer of Kaiser Permanente, to learn more.”

Weekend update

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medicare, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services (CMS) hosted health tech leaders at a Health Tech Ecosystem Connectathon event in Washington, D.C., Thursday [November 13, 2025] to showcase progress on its interoperability pledge.
    • “In late July, the CMS and the White House jointly announced a new focus on driving healthcare interoperability and getting health data into Medicare patients’ hands. The push for innovative products that ease health data transfer stems not from regulation, but from voluntary commitments made by industry to uphold new standards set out by the CMS. 
    • “The announcement was sprawling and included several spokes: a new CMS Interoperability Framework and a Health Tech Ecosystem that committed to working on conversational AI, modern digital identity verification and diabetes apps. 
    • “The CMS also committed to improving Medicare beneficiaries’ digital experience with CMS websites.” * * *
    • “The CMS debuted a beta prototype of its new national provider directory, multiple attendees said. The directory will allow Medicare beneficiaries to find providers that accept Medicare and will be available via a free FHIR API. 
    • “One participant noted that the CMS will update the public on its progress online and via a GitHub repository, an open-access cloud repository for projects that also tracks changes.  
    • Multiple companies also demonstrated products that meet the standards set out by the CMS in July for its so-called CMS Aligned Networks.”
  • Federal News Network shares OPM Associate Director for Healthcare and Insurance Shane Stevens views on the Open Season and the FEHB / PSHB program generally.

From the public health and medical / healthcare research front,

  • The Wall Street Journal offers women information about the Food and Drug Administration’s recent removal of a black box warning from all forms of menopausal hormone therapy.
  • Wired reports,
    • “GLP-1s are being studied for a wide range of conditions. Now, scientists will test whether their anti-inflammatory properties can help alleviate symptoms of long Covid.”
  • and
    • “The Aedes aegypti mosquito that can carry dengue, yellow fever, and Zika was thought to be too reliant on a hot and wet climate to survive in the Mountain West. But now, a population is thriving in Western Colorado.
  • The Washington Post adds,
    • “When Susan Akin first started injecting a coveted weight-loss drug early this year, the chaos in her brain quieted. The relentless cravings subsided — only they’d never been for food.
    • “The medication instead dulled her urges for the cocaine and alcohol that caused her to plow her car into a tree, spiral into psychosis and wind up admitted to a high-end addiction treatment center in Delray Beach, Florida.
    • “Doctors at Caron Treatment Centers tried a novel approach for the slender 41-year-old by prescribing her Zepbound, part of a blockbuster class of obesity and diabetes medications known as GLP-1s. Federal regulators have not approved the drugs for behavioral health, but doctors are already prescribing them off-label, encouraged by studies suggesting that they could reshape addiction treatment.
    • “Scientists caution that the research remains nascent. Health insurers do not cover the pricey drugs for that purpose. Addiction specialists say the medications might not be a cure but may work as a tool to quell addictive behaviors.”
  • MedPage Today informs us,
    • “Blood Test May Be a ‘Viable Alternative’ in Liver Cancer Surveillance. Investigational multi-target test more sensitive than ultrasound, but fell short in specificity.
  • The New York Times points out the best foods and drinks to resolve constipation.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health’s operations saw year-over-year improvement for the quarter ended September 30, but the nonprofit health system continues to be weighed down by rising expenses and reimbursement challenges.
    • “Despite strong volume, salary cost management, length-of-stay improvements and higher productivity, CommonSpirit’s financial performance continues to be impacted by expenses growing at a faster pace than revenue,” management said in a press release issued Friday.
    • “A significant impact to the organization’s revenue comes in the form of challenges with payers on denials and timely payments, and payment increases from both government and non-government payers that do not keep up with inflation,” management said.
    • “The 138-hospital system reported an as-recorded operating loss of $396 million (-4.0% operating margin) for the quarter ended September 30, its first fiscal quarter in 2026, as compared to the prior year’s $331 million operating loss (-3.5% operating margin).”
  • and
    • “Maven Clinic is expanding its maternity program to make pregnancy care more precise and personalized.
    • “The expansion includes remote monitoring to identify risks earlier and help address complications. Maven is also adding a NICU program to help get babies home faster through parent preparedness. New features begin rolling out this month.
    • “There’s no typical pregnancy; it’s not a thing. And it’s 2025, and it’s time to not have a cookie-cutter approach,” Neel Shah, M.D., chief medical officer at Maven, told Fierce Healthcare in an advanced interview.
    • “Maven clients trust the company to take care of an entire population, per Shah. That requires providing the right care for the right person, which is now being enabled by a new level of access to data. A year ago, Maven still relied on what members shared about themselves and claims data, Shah said. Now, Maven also has insights from wearables.”
  • Per a November 11, 2025, company news release,
    • “Doc.com, a pioneering healthcare technology company, proudly announces the launch of its new telemedicine platform and services. The platform combines artificial intelligence and blockchain-based technologies to enhance patient access, data security, and care coordination. Through a seamless mobile experience, patients can connect with licensed healthcare professionals within their state to receive quality care conveniently and securely. As part of its introductory rollout, new users may access up to 15 minutes of complimentary teleconsultation, available in eligible jurisdictions and subject to applicable regulations. These minutes may be used across one or multiple sessions as part of an initial trial experience. Subsequent consultations will be available at standard rates.
    • “Doc.com’s United States application rollout begins today with Phase 1 launching in West Virginia, followed by Virginia soon after. The company will then expand to the remaining U.S. states in three additional phases throughout 2026, concluding with full nationwide availability by early 2027. In addition to its United States rollout, Doc.com is introducing a blockchain component, designed to ensure secure, transparent, and efficient transactions across the healthcare ecosystem. This technology supports telemedicine consultations, medical record management, and AI-driven diagnostics, creating a fully integrated platform.”

Monday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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

Tuesday Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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


       

Monday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Weekend update

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

From Washington DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Friday Report

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

Happy Halloween!!

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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

Weekend update

David Ermer–CDC, Congress, Medicare, Obesity, U.S. Healthcare–

From Washington, DC

  • As the FEHBlog noted on Friday, the Senate will be in session this week, but not the House of Representatives. There is only one Senate committee meeting scheduled for this week. The Senate press gallery adds,
    • “The Senate stands adjourned until 3:00 p.m. on Tuesday, October 14th. At that time, following any Leader remarks, the Senate will be in a period of Morning Business.
    • “At approximately 5:30 p.m., the Senate will vote on cloture on the motion to proceed to H.R.5371; House passed Continuing Resolution.
    • “Further votes are possible.”
  • The Wall Street Journal reports,
    • “The Trump administration is attempting to retain some CDC staffers after initially notifying them of layoffs on Friday.
    • “The National Public Health Coalition estimated 1,300 CDC workers were laid off, with about 700 rehired on Saturday.
    • “The White House initiated mass layoffs across the government last week.”
  • STAT News tells us,
    • “Centers for Disease Control and Prevention staff behind the agency’s flagship publication had suffered deep cuts as part of the firings the Health and Human Services Department has blamed on the government shutdown, according to five people familiar with the situation. But as of Saturday evening, the terminations appeared to have been rescinded.
    • “An HHS official, speaking on condition of anonymity, said workers who produce Morbidity and Mortality Weekly Report may have mistakenly received reduction-in-force notices because of coding errors in their job classifications.”

From the public health and medical / Rx research front,

  • The New York Times identifies the cost common signs of a heart attack and explains that those signs aren’t all sudden or intense according to experts.
    • “I had a relative who experienced chest pain one afternoon. He brushed it off and said that he’d sleep on it and that if he still felt lousy, he’d go to the hospital the next day.
    • “He died of a heart attack that night.
    • “Dr. Donald Lloyd-Jones, a professor of cardiology at Boston University Chobanian & Avedisian School of Medicine, told me he understood why someone would hesitate to go to the emergency room.
    • “It’s “a very human thing” to assume you’re overreacting, he said. “You don’t want to cry wolf.”
    • “But acting quickly when you have symptoms of a heart attack is critical. They happen when blood flow to your heart is cut off or reduced. Without blood flow, the affected heart muscle will begin to die. And any delay in getting care can cause irreversible damage, said Dr. Seth Martin, a cardiologist at Johns Hopkins Medicine.”
  • MedPage informs us,
    • “Cardiovascular (CV) disease is the primary cause of maternal morbidity and mortality, but study did not find statistically significant links between adolescent heart health with later pregnancy outcomes.
    • “Participants with optimal CV health in both adolescence and young adulthood had the lowest incidence of gestational diabetes and hypertension and hypertensive disorders of pregnancy.
    • “Expert says study could still offer insight into how heart health trajectories impact pregnancy.
  • Per Medscape Today,
    • “The GLP-1 receptor agonist tirzepatide confers the same benefit in women as it does in men with obesity-related heart failure with preserved ejection fraction (HFpEF), according to a new analysis from the SUMMIT trial.
    • “Results from the randomized study also showed that women with obesity-related HFpEF had higher risk factors for worse outcomes than men with HFpEF, including greater adiposity, more severe symptoms, and poorer exercise capacity. The same trial found that women also had reduced risk with lower left ventricular mass and paracardiac fat deposition than men.
    • “We know that there are important sex differences in the heart and the vasculature in patients with HFpEF,” investigator Barry Borlaug, MD, a cardiologist at Mayo Clinic in Rochester, Minnesota, said during a late-breaking clinical research session at the Heart Failure Society of America (HFSA) 2025 Annual Scientific Meeting.”
  • BioPharma Dive points out,
    • “Each year, a small number of babies are born mostly, if not fully, deaf because one of their genes isn’t working.
    • “The gene normally makes a protein that the hairs in our inner ears need to relay sound signals to the brain. Without that protein, people with this rare form of hearing loss often rely on cochlear implants for their entire lives.
    • “But in the near future, genetic medicine may offer another option. On Sunday, fresh results from a small clinical trial showed that, among a dozen children given a gene therapy from Regeneron Pharmaceuticals, most are now hearing well enough to not need help from implants.
    • ‘Encouraged by those results, Regeneron plans to submit an approval filing to the Food and Drug Administration by the end of the year.”

From the U.S. healthcare business front,

  • HR Dive reports,
    • “The majority (77%) of employees surveyed by Voya Financial said they plan to spend more time re-assessing their benefit elections during open enrollment this year — up from 69% last year.
    • “Likewise, 63% of Americans surveyed told the firm they “strongly agree” or “agree” that their financial stability has a direct impact on their mental health — up from 57% over the past two years.
    • “Voya researchers noted that workers may benefit from more education about retirement in particular, with only about half of workers feeling “very” or “somewhat” prepared for retirement.”
  • The Wall Street Journal relates,
    • “Some 25% of U.S. employers with 200 or more employees offered menopause-related benefits in 2025, an increase of 10 percentage points from 2023.
    • ‘The annual cost of missed work due to menopause-related symptoms in the U.S. is estimated at $1.8 billion.
    • “Rhode Island became the first state to mandate reasonable workplace accommodations for employees experiencing menopause-related symptoms.”
  • Medical Economics lets us know where physician pay satisfaction is highest in the U.S.
  • Per Fierce Healhcare,
    • “Between 2012 and 2023, registered nurses’ inflation-adjusted wages grew at a slower rate than other support and billed-for healthcare occupations, a review of Bureau of Labor Statistics data on millions of workers found.
    • “The “fairly flat” 0.51% annual growth for RNs, the nation’s largest clinical workforce, across all employment settings came amid the industry’s broad demand for these types of admissions, researchers wrote in the study published this week.
    • “At the same time, the increases were greater for lower-paid support positions like licensed practical nurses (LPNs; 0.79% growth per year) and nurse assistants (NAs; 1.41% growth per year).
    • “That trend may suggest healthcare employers looking to check spending are prioritizing lower-paid roles, they wrote. By 2023, average annual wages for RNs were $94,480, compared to $60,790 for LPNs and $39,610 for NAs.
    • “Although hiring NAs and LPNs instead of RNs could cut costs initially, this could translate to worsening patient outcomes and higher overall expenses for health care organizations, as these workers may lack the training or scope of practice to manage more complex care needs,” researchers from the University of Michigan, Yale University and Johns Hopkins University wrote in Health Affairs.”
  • Modern Healthcare reports,
    • Humana is taking another step to limit its exposure to the volatile Medicare market.
    • “The health insurance company will remove all of its Medicare Part D prescription drug plans from enrollment portals for brokers and other third-party marketers on Nov. 9, it announced Friday.
    • “As we approach this year’s annual enrollment period, we are notifying you that Humana has made the difficult decision to not use agents to sell our prescription drug plans,” Humana wrote in a notice emailed to marketers. The Medicare annual enrollment period begins next Wednesday and runs until Dec. 7.”
  • and
    • “Hackensack Meridian Health is ramping up its Amazon One Medical partnership to expand primary care as part of its outpatient push. 
    • “The Edison, New Jersey-based health system is set to open its third One Medical facility in the second quarter of next year, Hackensack CEO Bob Garrett said. Hackensack initially aimed to open 20 clinics over 10 years but plans to move faster and expand that target given the partnership’s success, he said.
    • “Amazon in 2023 acquired virtual and brick-and-mortar primary care service provider One Medical for $3.9 billion. Amazon has since partnered with health systems across the country to grow the subscription-based model for commercially insured patients, helping boost systems’ specialty care referrals.”