Friday report

CMS

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, U.S. Healthcare, Wellness–

From Washington, DC,

  • The Washington Post reports,
    • “House Republicans unveiled a new health care proposal Friday as they aim to address concerns about rising health insurance costs just weeks before enhanced Affordable Care Act subsidies expire.
    • “The legislation would codify and expand health plans for small businesses, fund reductions of premiums for low-income people in the individual health insurance market and increase transparency in prescription drug pricing, according to House Republican leadership aides.
    • “The proposal would also allow for a separate vote on an extension of the premium ACA tax credits, which subsidize health insurance for most of the 24 million Americans who buy their coverage from the Obamacare Marketplace — the central demand Democrats and moderate Republicans have made in the recent health care debate.
    • “The House is expected to vote on the proposal next week before leaving Washington for a two-week holiday break. If passed, it is unclear if the proposal could succeed in the Senate, where it would require 60 votes to overcome a filibuster.”
  • FEHBlog observation — This week, the Democrat leadship in the Senate offered a three year extension extension of the Biden subsidies while the Republican leadership offered a new approach with no transistion period. Both offerings were doomed to fail. The FEHBlog hopes that cooler heads prevail over the next week.
  • Govexec relates,
    • “The House voted 231-195 on Thursday to pass legislation that would nullify President Trump’s efforts to strip more than 1 million federal workers of their collective bargaining rights, sending the measure over to the Senate, where its prospects are less rosy.
    • “Twenty Republican lawmakers broke ranks to support the Protect America’s Workforce Act (H.R. 2550) on the floor. Introduced by Reps. Jared Golden, D-Maine, and Brian Fitzpatrick, R-Pa., the measure effectively nullifies Trump’s March executive order barring unions at more than 40 federal agencies under the guise of national security and bars federal agencies from terminating any union contracts that were in place prior to the edict’s signature.”
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Dec. 11 announced the launch of the Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence Model, a voluntary payment model that will fund up to 30 chronic disease prevention and health promotion proposals. The proposals must include evidence-based functional or lifestyle medicine interventions not covered by Original Medicare. Under the MAHA ELEVATE Model, CMS said it will evaluate necessary data on the cost and quality of such interventions to inform future decisions on the feasibility of including them in Original Medicare. The agency will release a funding notice in early 2026 for the first cohort, which will begin Sept. 1, 2026. The second cohort will begin one year later.”
  • The U.S. Office of Personnel Management announced today that it is seeking public comments on its plan to resurrect its FEHB and now also PSHB health claims data warehouse.
    • “OPM is collecting service use and cost data from FEHB and PSHB Carriers, including medical claims, pharmacy claims, encounter data, and provider data. This data will enable OPM to oversee health benefits programs and ensure they provide competitive, quality, and affordable plans. OPM requires Carriers to report necessary information and permit audits and examinations to manage the FEHB Program effectively. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered entities, including carriers, to disclose protected health information (PHI), including service use and cost data, to health oversight agencies, such as OPM, for oversight activities authorized under 45 CFR 165.512(d)(1).”
    • This is a legally flawed analysis. The FEHB Act, 5 U.S.C. Sec. 8910(b), states
      • “(b) Each contract entered into under section 8902 of this title shall contain provisions requiring carriers to—
      • “(1) furnish such reasonable reports as the Office determines to be necessary to enable it to carry out its functions under this chapter; and
      • “(2) permit the Office and representatives of the Government Accountability Office to examine records of the carriers as may be necessary to carry out the purposes of this chapter.”
    • Furnishing all claims data to OPM is a not a reasonable report in any sense of the English language, and the HIPAA Privacy Rule does not give health oversight agencies new data access rights. See Fed. Reg. 82,462, 82,528 (Dec. 28, 2000). OPM should head back to the drawing board for consultations with carriers.
    • The public comment deadline is February 10, 2026.
  • On a related note, per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is pleased to announce the 2026 CMS Burden Reduction Conference taking place February 25, 2026, from 9:00 a.m. to 1:00 p.m. ET. This year’s conference will be a hybrid event, with in-person programming at the Hubert H. Humphrey (HHH) Building in Washington, DC, and a fully supported virtual option for remote attendees. In-person attendance will be limited due to space.”
  • OPM should hold a similar event for overburdened FEHB and PSHB carriers.

From the Food and Drug Adminstration front,

  • Per Fierce Pharma,
    • “Amid a swell of regulatory successes in the myasthenia gravis arena this decade, Amgen is wading into the fray with a new indication for its monoclonal antibody Uplizna.
    • “Thursday, the FDA greenlighted Uplizna (inebilizumab) to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. After two loading doses, Uplizna for gMG is administered just twice a year, Amgen noted in a Dec. 11 press release.”
  • and
    • “After a three-decade drought of new antibiotics to treat gonorrhea, the FDA has signed off on two first-in-class oral treatments for the sexually transmitted infection (STI), which affects more than 80 million people around the world each year. 
    • “On Friday, the U.S. regulator green lit Innoviva’s Nuzolvence (zoliflodacin) for uncomplicated urogenital gonorrhea. The nod comes less than 24 hours after the agency granted an approval in the same indication to GSK’s Blujepa, which was already on the market for uncomplicated urinary tract infections following its approval in March.
    • “The endorsements are similar in that both therapies are indicated for those ages 12 and older where standard of care treatment is contraindicated or where patients are intolerant or unwilling to use the first line of treatment.”
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance to the enVast mechanical thrombectomy system from Texas-based Vesalio.
    • “The company said the system offers a new approach to clot capture and the removal of large thrombus burden (LTB) in patients undergoing primary percutaneous coronary intervention (PCI). Thrombectomy is used in the coronary arteries to quickly remove clots to restore blood flow following a heart attack to minimizing myocardial damage.
    • “With FDA clearance and the upcoming U.S. launch of enVast, we are proud to introduce a device that we truly believe redefines coronary thrombectomy,” Steve Rybka, CEO of Vesalio, said in a statement. “Clinical experience internationally has consistently demonstrated its safety and effectiveness in managing complex LTB situations.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity continues to increase in most areas of the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News adds,
    • “The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing emergency department or urgent care visits for children ages 9 months to 4 years. It was 56% effective for those ages 5-17 years old. “These findings suggest that vaccination with a 2024–2025 COVID-19 vaccine dose provided children with additional protection against COVID-19–associated ED/UC encounters compared with no 2024–2025 dose,” the CDC wrote.”
  • The New York Times reports,
    • “To treat their pain, anxiety and sleep problems, millions of Americans turn to cannabis, which is now legal in 40 states for medical use. But a new review of 15 years of research concludes that the evidence of its benefits is often weak or inconclusive, and that nearly 30 percent of medical cannabis patients meet criteria for cannabis use disorder.
    • “The evidence does not support the use of cannabis or cannabinoids at this point for most of the indications that folks are using it for,” said Dr. Michael Hsu, an addiction psychiatrist and clinical instructor at the University of California, Los Angeles, and the lead author of the review, which was published last month in the medical journal JAMA. (Cannabis refers to the entire plant; cannabinoids are its many compounds.)”
  • The AP informs us,
    • “The U.S. suicide rate dropped slightly last year from some of the highest levels ever reported, preliminary data suggests. Experts say it’s hard to know exactly why, or whether the decline will continue.
    • “A little over 48,800 suicide deaths were reported in 2024, according to provisional data from the Centers for Disease Control and Prevention, roughly 500 fewer than the year before.
    • “The overall suicide rate fell to 13.7 per 100,000 people.”
  • The Washington Post relates,
    • “Solving a technical challenge that has stymied science for 40 years, researchers have built a robot with an onboard computer, sensors and a motor, the whole assembly less than 1 millimeter in size — smaller than a grain of salt.
    • “The feat, accomplished by a partnership of researchers at the University of Pennsylvania and University of Michigan, advances medicine toward a future that might see tiny robots sent into the human body to rewire damaged nerves, deliver medicines to precise areas, and determine the health of a patient’s cells without surgery.”
  • Per Healio,
    • “GLP-1 receptor agonists are not associated with increased risks for dry age-related macular degeneration or cataract development, according to two recently published studies.
    • “The data instead showed significantly reduced risk for cataracts, as well as lower risk for dry AMD, linked with the use of GLP-1s, according to Abhimanyu Ahuja, MD, an ophthalmology resident at the Oregon Health & Science University Casey Eye Institute, and colleagues.
    • “Other studies have demonstrated that these medications have anti-inflammatory and neuroprotective properties,” Ahuja told Healio. “We wondered whether they might influence the risk of conditions like macular degeneration or cataracts in older adults.”
  • Per MedTech Dive,
    • “AtriCure, whose devices are used to treat atrial fibrillation and related conditions, said Thursday the first procedures were performed in patients with its new dual energy platform.
    • “The system integrates pulsed field ablation with a radiofrequency ablation approach using the company’s cardiac clamp technology. Surgeons can use either method independently or in combination.
    • “The platform is not yet approved for use in any market. AtriCure said it expects to initiate a clinical trial in the coming year.”
  • Per Biopharma Dive,
    • “Arcus Biosciences will terminate work on a TIGIT-targeting cancer drug following a decision to cancel a Phase 3 trial because it didn’t appear likely to improve patients’ survival, the company said in a statement Friday.
    • “Called domvanalimab, the drug was being tested in combination with the immunotherapy zimberelimab and chemotherapy against Bristol Myers Squibb’s Opdivo and chemo in gastric and esophageal cancers that haven’t been treated before. Arcus said an independent data committee recommended ending the trial because the domvanalimab combination wasn’t likely to help patients live longer.
    • “The domvanalimab-based combination was the centerpiece of a partnership with Gilead Sciences that led the bigger company to buy a 33% stake in Arcus and pay $900 million just to secure rights.”

From the U.S. healthcare business and artificial intelligence front,

  • Healthcare Dive reports,
    • “Hospitals are managing series of cost, workforce and reimbursement challenges as they navigate uncertainty at the close of 2025 and beyond, according to a new report from Kaufman Hall.
    • “Health systems are attempting to mitigate the impact of tariffs and increasingly expensive supplies, according to Kaufman Hall’s 2025 Health System Performance Outlook report. At the same time, hospitals are trying to retain clinical staff and outsource other functions, according to the report.
    • “Only 30% of hospital leaders surveyed expect balance sheets to improve in 2026, while 30% expect them to lower and 40% projected little change. The split highlights how uncertain health systems feel about the future, especially from recent regulatory changes in the “Big Beautiful Bill” and the likely expiration of Affordable Care Act subsidies.”
  • Beckers Hospital Review relates,
    • “Dallas-based Tenet Healthcare reached a record high stock price of $218 on Nov. 25, capping off a transformative year that highlights investor confidence in the system’s ongoing shift toward specialty and outpatient care.
    • “As of Dec. 12, Tenet stock remained elevated at $199, up nearly 60% from $125 on Jan. 2. The spike reflects investor optimism around Tenet’s long-term strategy to transform into a value-based care enterprise anchored by its ambulatory business, United Surgical Partners International.
    • “In 2024, Tenet sold 14 hospitals for a combined $4.8 billion as part of a sweeping overhaul. The system now operates 50 acute-care hospitals while aggressively expanding its ambulatory surgery center footprint through USPI.”
  • Beckers Payer Issues tells us about 14 payer AI moves this year and “Turquoise Health has detailed its first comprehensive payer price transparency scores in its 2025 impact report, evaluating machine-readable file quality across 97 payers.” 

Midweek update

David Ermer–ACA, AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, Medicare, OPM, Patient safety, SDOH, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Wall Street Journal reports
    • “The Senate plans two healthcare votes Thursday: one on a GOP bill that would put as much as $1,500 a year into health savings accounts in lieu of providing subsidies to cover premiums, and the second on a Democratic plan that extends ACA subsidies for three years. Neither is expected to reach the 60 votes needed to advance, but the willingness of some Republicans to consider any form of ACA extensions has opened the door to possible talks if the partisan measures fail.
    • “In the House, Speaker Mike Johnson (R., La.) said Republicans plan to put on the floor next week a package of healthcare proposals that doesn’t include extending subsidies. But other lawmakers see an ACA extension as the only way to prevent widespread pain ahead of the 2026 midterms and get a GOP-led Congress in position to make more sweeping changes.
    • “Rep. Jim Jordan (R., Ohio)—a onetime leader of the hard-line House Freedom Caucus—argued in a closed-door House Republican meeting that the party needed its own plan to temporarily extend the subsidies in tandem with more sweeping changes. If they didn’t, he warned, conservatives could be sidelined by centrists’ push to bring their own ACA extension to the floor.
    • “There’s a whole list of good things that we need to put in the legislation,” Jordan said in an interview. “But we also need to recognize reality, which is the cliff is coming in 21 days, and we have members who are very concerned about that. I think we all are.”
  • The Hill adds,
    • “The House on Wednesday easily passed the annual defense policy bill, sending the mammoth, $900 billion measure to the Senate ahead of the year-end deadline.
    • “The measure, known as the National Defense Authorization Act (NDAA), passed the lower chamber by a vote of 312-112. Ninety-four Democrats and 18 Republicans opposed the bill.
    • “The NDAA, a traditionally bipartisan bill that lays out defense priorities for the next year, would increase pay for service members, provide some military aid to Ukraine, restrict U.S. investment in China and fully repeal sanctions on Syria, among other things.”
  • Axios points out,
    • “Lab testing companies including giants Quest Diagnostics and LabCorp are pressing Congress to stop hundreds of millions of dollars of Medicare cuts for diagnostic tests that are due to take effect at the end of January.” * * *
    • “A 15% reduction to Medicare payments for nearly 800 lab tests is set to take effect Jan. 31, followed by additional cuts in following years.
    • “The change stems from 2014 legislation that aimed to align Medicare reimbursements for lab tests more closely with commercial payments.
    • “Medicare cuts that previously went into effect from the legislation cost labs nearly $4 billion over three years. Since then, the diagnostics industry has successfully argued the cuts are based on incomplete and outdated pricing information.” * * *
    • “Federal budget analysts previously used the Consumer Price Index as a proxy for lab payments. That measurement showed that delaying the changes appeared to save Medicare money. 
    • But the analysts have changed their model and now estimate that delaying the payment cuts will add to Medicare costs.”
  • Govexec tells us,
    • “The heads of the Office of Management and Budget and the Office of Personnel Management unveiled plans Wednesday to build a single information technology platform to manage all human capital data across the federal government. 
    • “In a joint memo, OMB Director Russ Vought and OPM Director Scott Kupor described a two-year plan to transition the federal government’s collection of disparate human resources networks onto a single system dubbed Federal HR 2.0.
    • “For too long, the Federal Government has lacked what is taken for granted at any other organization — a single system of record for personnel management. Instead, the Federal Government spends an inordinate amount each year on numerous costly, duplicative, and outdated core human capital management (“Core HCM”) systems,” the memo said. 
    • “As part of the plan, the memo said OMB and OPM officials will lead efforts “to procure a modern, best-in-class commercial Core HCM system” for governmentwide adoption by fiscal 2028.”
  • The Journal of Accountancy informs us,
    • “The IRS provided guidance Tuesday on new tax benefits for health savings accounts (HSAs) that include allowing bronze and catastrophic plans to be considered HSA-compatible under Sec. 223.
    • “The changes, which were part of H.R. 1, P.L. 119-21, commonly known as the One Big Beautiful Bill Act, generally expand the availability of HSAs under Sec. 223 and were outlined in Notice 2026-05.” * * *
    • “The IRS guidance also covered:
      • “Telehealth and remote care services: H.R. 1 made permanent the ability to receive telehealth and other remote care services before meeting the HDHP deductible while remaining eligible to contribute to an HSA, effective for plan years beginning on or after Jan. 1, 2025.
      • “Direct primary care (DPC) service arrangements: Beginning Jan. 1, 2026, an otherwise eligible individual enrolled in certain DPC service arrangements may contribute to an HSA. In addition, they may use their HSA funds tax-free to pay periodic DPC fees.”
    • “The IRS is seeking comments on Notice 2026-05 by March 6, 2026.”
  • Per Fierce Pharma,
    • “For more than two years, the U.S. Federal Trade Commission has been taking certain drugmakers to task over their alleged listing of “improper” patents in an FDA registry, a practice the agency says thwarts generic competition. 
    • “Now, after several prior wins with the effort, the agency is celebrating once again as Teva has agreed to remove more than 200 patents from FDA records, according to a Dec. 10 announcement.
    • “Following pressure from the FTC, Teva has asked the FDA to delist patents on certain products for asthma, diabetes, chronic obstructive pulmonary disease and for epinephrine autoinjectors, the FTC said. The removals from the FDA’s Orange Book registry will “pave the way for greater competition for generic alternatives” to more than 30 products, the agency explained.” * * *
    • “The AHA Board of Trustees has engaged WittKieffer to conduct a national search for Pollack’s successor as part of a planned transition. Pollack will remain fully engaged until the transition is complete.
    • “Recognizing Pollack’s commitment to the association, the AHA Board last month voted to bestow on him the title of AHA President and CEO Emeritus for when the transition is complete.”
  • The American Medical Association announced,
    • “AHA President and CEO Rick Pollack today announced his plans to retire by the end of 2026. A 43-year veteran of the association, Pollack has served as its chief executive for the past decade.
    • “Under Pollack’s leadership, the AHA steered hospitals through the COVID-19 pandemic, securing critical resources and regulatory flexibility to keep hospitals and health systems open and caring for patients during the most challenging public health crisis of recent time. Pollack launched bold initiatives to strengthen the health care workforce, advance quality and patient safety, and fortify cybersecurity defenses through partnerships with the FBI and other government agencies.
  • Per a Department of Justice news release,
    • “United States Attorney David Metcalf announced today that Recovery Centers of America (RCA) has agreed to pay $1,000,000 to resolve allegations that it failed to comply with provisions of the Controlled Substances Act (CSA) that are designed to prevent the diversion of controlled substances for illegal uses, and an additional $1,000,000 to resolve allegations that it violated the False Claims Act (FCA) by billing the government for drug and alcohol treatment services that it failed to adequately provide.
    • “The United States’ allegations under the CSA arise from audits and investigations the Drug Enforcement Administration (DEA) conducted at RCA facilities in Pennsylvania and Maryland between 2019 and 2024. Based on those audits and investigations, the United States contends that RCA dispensed controlled substances in an unlawful manner, that certain controlled substances were missing from the company’s records, and that the company failed to comply with additional recordkeeping requirements of the CSA.
    • “In addition, the United States alleges that, at certain facilities during a period from 2017 through 2019, RCA violated the FCA by billing the Federal Employees Health Benefits Program and Medicaid for the care of beneficiaries to whom it failed to provide and document the requisite treatment services.” * * *
    • “The resolution obtained in this matter was the result of a coordinated effort among the United States Attorney’s Office for the Eastern District of Pennsylvania, the DEA, the Office of Personnel Management Office of Inspector General, and the Department of Health and Human Services Office of Inspector General.
    • “The matter was handled in the U.S. Attorney’s Office for the Eastern District of Pennsylvania by Assistant U.S. Attorneys Peter Carr and Charlene Keller Fullmer and former auditor Dawn Wiggins.
    • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic.
    • “GSK originally developed the drug, Augmentin XR, and won FDA approval for it in 2002. The British company then struck a deal in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy’s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by USAntibiotics, which won the priority voucher.
    • “FDA Commissioner Martin Makary trumpeted the approval as a boon for crucial supply chains of medications that often end up in shortages. The move “will strengthen domestic manufacturing and increase our national security,” Makary said in a statement Tuesday.”
  • Fierce Pharma adds
    • “The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the first therapy of its kind for the rare disease and making Italy’s Fondazione Telethon the first nonprofit to usher a gene therapy across the regulatory finish line in the U.S.
    • “Branded as Waskyra, the drug is specifically indicated for children 6 months and older, as well as adults who have a mutation in the WAS gene. To be eligible for the ex vivo gene therapy, patients must have no available human leukocyte antigen-matched related stem cell donor and be cleared for hematopoietic stem cell transplantation, the FDA said in its Dec. 9 announcement.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” director of the FDA’s Center for Biologics Evaluation and Research (CBER) Vinay Prasad, M.D., said in a release.”
  • and
    • “A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
    • The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
    • Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.”
  • Per Beckers Health IT,
    • “The FDA has qualified the first AI-based drug development tool to support metabolic dysfunction-associated steatohepatitis clinical trials.
    • “The cloud-based tool, AI-Based Histologic Measurement of NASH (AIM-NASH), is designed to assist pathologists in assessing liver biopsy images, according to a Dec. 8 news release. It evaluates disease activity by scoring steatosis, hepatocellular ballooning, lobular inflammation and fibrosis according to the NASH Clinical Research Network scoring system.
    • “AIM-NASH uses AI to analyze digital images of liver tissue, but human pathologists remain responsible for interpreting the results. They review the entire slide and AIM-NASH output before accepting or rejecting the scores.”
  • BioPharma Dive notes,
    • “Vinay Prasad and two other officials within the Food and Drug Administration office regulating many genetic medicines have outlined a stricter approval framework for the next CAR-T cell therapies developed for cancer. In an article published Monday in the Journal of the American Medical Association, the trio wrote that newer CAR-T treatments need to extend survival, or the time before a type of event occurs, in randomized, controlled trials. The control groups in those studies must also take into account the existing standard treatments, including other approved CAR-T therapies, and prove superior unless “adequately justified and discussed” with the FDA. The new protocol represents a higher approval bar for CAR-T therapies, which, historically, have been cleared based on their ability to induce responses in single-arm studies.” 

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today said the United States has 1,912 confirmed measles cases so far in 2025, an increase of 84 cases since last week and a bad sign as holiday gatherings, travel, and indoor activities is set to pick up in the final weeks of the year. 
    • “In January 2026, the United States is at risk of losing its measles elimination status because of ongoing transmission chains from a West Texas outbreak that began early last year and sickened roughly 800 people. The country first gained elimination status in 2000. 
    • “Eighty-eight percent of cases in the United States this year are outbreak-associated, and there have been 47 outbreaks recorded. Last year, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.
    • “Currently Utah, Arizona, and South Carolina are seeing large outbreaks that since Thanksgiving have pushed state totals well past 100 cases. Those outbreaks have been marked by exposures at schools and churches in communities with low vaccination levels.”
  • STAT News relates,
    • “Federal health officials on Wednesday [December 10] expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.
    • “The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
    • ‘The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.
    • “No deaths have been reported in the outbreak, which was announced Nov. 8.
    • “Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. With the expanded definition, the CDC identified 10 additional cases that occurred from December 2023 through July 2025.”
  • and
    • “While extensive studies have found Covid-19 vaccines to be safe, effective, and to have saved millions of lives during the pandemic, these shots come with a rare but real risk of inflamed heart muscle, or myocarditis. Scientists on Wednesday reported that they have identified a pair of immune signals they believe drive these cases — and offered early evidence that these signals can be blocked.
    • Researchers sifted through previous Covid vaccine studies and identified a pair of immune signaling molecules, or cytokines, present at higher levels in the blood of vaccine recipients with myocarditis: CXCL10 and interferon-gamma (IFN-γ). The authors found that these signals could also be triggered in the lab when immune cells were exposed to the Pfizer and Moderna Covid vaccines, or when mice were inoculated.
    • “Scientists found that using antibodies to block CXCL10 and IFN-γ reduced signs of cardiac stress in vaccinated mice and in cardiac spheroids, three-dimensional growths of human cells meant to mimic some aspects of the heart’s structure and function. The authors also found they could block the cytokines’ effects with genistein, a compound found in soybeans and other legumes that has been linkedto reduced inflammation.
    • “The findings, published in the journal Science Translational Medicine, come as messenger RNA vaccines face scrutiny from the Trump administration and some lawmakers. That has forced researchers studying these shots to strike a tricky balancing act between reporting new insights on adverse events while making clear that the shots are safe overall.
    • “I want to emphasize this is very, very rare. This study is purely to understand why. In those rare cases, what’s going on? People talk about it, and here we provide a mechanism,” said Joe Wu, director of Stanford Cardiovascular Institute and the study’s senior author.”
  • Medscape tells us,
    • “As women age, they face several health risks related to the menopause transition. Treating these risk factors, which include obesity and high blood pressure, can reduce the risks for diabetes, cardiovascular disease (CVD), and other health problems.
    • “These risks also can be driven by age-related changes that occur around the time of menopause, said Marie K. Christakis, MD, MPH, assistant professor of obstetrics and gynecology and menopause and mature women’s health at the University of Toronto in Toronto, during a presentation at the Diabetes Canada and Canadian Society of Endocrinology and Metabolism (CSEM) Professional Conference 2025.
    • “Women at midlife are in what I term a cardiovascular storm,” she said. “More than 42% of American women between ages 40 and 59 years have a BMI over 30, and the prevalence of obesity is higher among women between ages 40 and 59 years. Generally, menopause occurs naturally between ages 46 to 54 years, and central adiposity is a particular issue.” 
  • MedPage Today notes,
    • “In a large phase III trial of adjuvant treatment for early-stage breast cancer, the investigational oral drug giredestrant reduced the risk of invasive disease recurrence by 30% versus standard endocrine therapy.
    • “Among more than 4,000 patients with hormone receptor (HR)-positive disease, 3-year invasive disease-free survival (IDFS) rates reached 92.4% with the next-generation oral selective estrogen receptor antagonist and degrader (SERD), as compared with 89.6% with standard of care (HR 0.70, 95% CI 0.57-0.87, P=0.0014).”
    • “The findings of the lidERA Breast Cancer trial mark the first benefit with a novel endocrine agent in early breast cancer in 20 years, not since the approval of aromatase inhibitors (AIs) in the 2000s, said Aditya Bardia, MBBS, MPH, of the University of California Los Angeles.
    • “Overall, the results support giredestrant as a potential standard endocrine option for patients with hormone receptor-positive breast cancer,” said Bardia, who presented the findings here at the San Antonio Breast Cancer Symposium.”
  • Fierce Pharma adds,
    • “Pfizer has rolled out detailed trial data suggesting Tukysa could be part of a new first-line treatment to delay the progression of HER2-positive breast cancer.
    • “The current standard of care for the disease includes induction chemotherapy in combination with Roche’s Herceptin and Perjeta, followed by a chemo-free maintenance phase with the two HER2 antibody drugs. Now, Pfizer has shown that adding Tukysa during the maintenance stage can improve patient outcomes.
    • “Specifically, addition of Tukysa to first-line maintenance therapy significantly reduced the risk of progression or death by 35.9%, according to investigator-assessed results from the phase 3 HER2CLIMB-05 trial, which were presented at the San Antonio Breast Cancer Symposium. Patients who received the Pfizer small molecule went 8.6 months longer without tumor progression, reaching 24.9 months at the median.
  • and
    • “A year after a clutch of major pharmas threw their weight behind a new campaign devoted to addressing the serious health disparities facing Black breast cancer patients, “Care for HER” has been shown to have a tangible positive impact on patients’ lives.
    • “Touch, The Black Breast Cancer Alliance and Unite for HER—the two nonprofit organizations behind the program—presented a study about that impact at the San Antonio Breast Cancer Symposium on Wednesday.
    • “The research centers ran a survey of 57 participants in the Care of HER program, all Black women who have been diagnosed with breast cancer, 93% of whom said they’d used the program’s resources.”
  • Per Cardiovascular Business,
    • “Intravascular lithotripsy (IVL) is a viable treatment option for patients with diabetes undergoing percutaneous coronary intervention (PCI), according to new findings published in The American Journal of Cardiology.[1]
    • “While IVL has demonstrated favorable procedural and clinical outcomes in general populations with calcified lesions, its performance in patients with diabetes mellitus remains insufficiently characterized,” wrote senior author Jose M. Montero-Cabezas, MD, PhD, a cardiologist with Leiden University Medical Center in The Netherlands, and colleagues. “Given the unique anatomical and pathophysiological features of coronary artery disease in diabetic patients, such as medial calcification, longer lesion length, and more frequent multivessel disease, there is a clear need to specifically evaluate the efficacy and safety of IVL in this higher-risk population.”
    • “Montero-Cabezas et al. tracked data from nearly 600 patients who underwent PCI with IVL from May 2019 to September 2024. All data came from the BENELUX-IVL registry, an international database open to all IVL patients. Patients with missing data were excluded.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS plans to launch a first-of-its-kind healthcare engagement platform, banking that perennial gripes about poor access and navigation will incentivize both consumers and rival companies to sign on.
    • “The platform will include data and services offered by CVS’ different health businesses — and those of participating industry partners. The goal is to create an integrated healthcare experience for consumers, hopefully enhancing their experience with the industry, lowering costs and improving outcomes, CVS executives said Tuesday during the healthcare giant’s investor day in Hartford, Connecticut. 
    • “CVS is also banking that the platform will also be a source of revenue by driving consumers to CVS products and services they might not know about otherwise.”
  • Kaufman Hall announced,
    • “Hospital volumes remained strong in October, while average length of stay declined, translating to a dip in net revenue per discharge. Bad debt and charity care continue to rise, and staffing levels are tightening.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • The American Journal of Managed Care lets us know,
    • “As states and federal programs accelerate the shift to value-based care, a new national survey suggests clinicians face a widening gap between policy expectations and the tools available to meet them.
    • “Tracking patient progress emerged as the biggest barrier—more than insurance—for mental health and primary care clinicians adapting to outcome-based payment models, according to October 2025 survey findings released by Twofold Health, an artificial intelligence (AI) clinical notetaking platform.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) targeting abnormal complexes of immunoglobulin for IgA nephropathy.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On December 17, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Medical Officer, David Rind, MD, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on January 14, 2026.”
  • Per MedTech Dive,
    • “Teleflex has struck deals to sell its acute care, interventional urology and OEM businesses for a combined $2.03 billion, the company said Tuesday.
    • “Montagu and Kohlberg, two private equity firms, are buying the OEM business for $1.5 billion. Intersurgical, an anesthesia and respiratory care medtech company, is buying the acute care and interventional urology businesses for $530 million.
    • “Needham analysts said in a note to investors that the total sale price is at the low end of their estimates. Yet RBC Capital Markets analysts told investors they view the update positively.”
    • * * * “Selling the units will leave Teleflex focused on its vascular access, interventional and surgical businesses. The company picked the businesses as the focus of its ongoing operations because they serve attractive, primarily hospital-focused end markets. Teleflex framed the split as a way to simplify its operating model and manufacturing footprint.”

Tuesday report

David Ermer–ACA, CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • MedPage Today reports,
    • “The number of Americans signing up for Affordable Care Act (ACA) health insurance for 2026 is moderately higher than it was at a similar time last year, initial new federal data show, even as subsidies set to expireopens in a new tab or window at the end of 2025 will make the coverage more expensiveopens in a new tab or window for many.
    • “Seen at face value, the data from the Centers for Medicare and Medicaid Services seem to defy predictions that many Americans facing pricier plans would drop out of marketplace coverage altogether next year. But experts caution that the numbers are an incomplete snapshot of total enrollment, which could still show a decline by the end of the open enrollment period.
    • “Overall, it’s just too early to know what any of this means,” said Jason Levitis, a senior fellow in the health policy division at the Urban Institute.
    • “The data released Friday show that by day 29 of the window for Americans to shop for ACA plans this year, nearly 5.8 million people had picked one. That’s nearly 400,000 more enrollments than by day 30 of the open enrollment period last year.
    • Meanwhile, this year’s enrollment numbers are about 1.5 million lower than the 7.3 million or so people who had signed up 32 days into the open enrollment period 2 years ago, showing there is some fluctuation year to year in when people sign up for coverage.
    • “In most states, for Americans who want coverage to start Jan. 1, the window to shop for ACA coverage began Nov. 1 and ends Dec. 15. People who want their coverage to start later can continue to select plans through Jan. 15.”
  • The Wall Street Journal adds,
    • “Senate Majority Leader John Thune (R., S.D.) said he would hold a vote later this week on a Republican measure aimed at controlling healthcare costs, amid party division over how best to head off big price increases next year for millions of households.
    • “Thune said Republicans have coalesced around legislation from Sens. Bill Cassidy (R., La.) and Mike Crapo (R., Idaho) [discussed in yesterday’s FEHBlog post] that would put as much as $1,500 a year into tax-advantaged health savings accounts when paired with lower-priced insurance plans in 2026 and 2027. The proposal doesn’t extend enhanced Affordable Care Act subsidies, which are due to expire after this year.
    • “The measure aims to provide an alternative to a Democratic proposal that extends the ACA subsidies for three more years. Votes on the two plans in the GOP-controlled Senate are set for Thursday, as Thune follows through on a promise made to Democrats as a condition for ending the government shutdown last month.
    • “So there will be something out there that Republicans will be able to talk about and support and vote for, and then we’ll see what happens Thursday,” Thune said. If neither proposal gets the 60 votes required to advance in the Senate, he said, “then we’ll see where it goes from there.”
  • Per a Senate news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is seeking information from stakeholders regarding the American Medical Association’s (AMA) monopoly of Current Procedural Terminology (CPT®) codes and its impact on patients, providers, and health care costs. Cassidy is asking stakeholders with relevant experience and knowledge of CPT ® coding contracts with the AMA to inform the Committee’s inquiry by responding to this questionnaire.
    • “As chair of the HELP Committee, Cassidy is using all tools at his disposal to lower costs for American patients. Thus far, the AMA evaded questions and failed to cooperate with Cassidy’s inquiry. If the AMA does not respond in a fulsome and transparent manner by December 15, 2025, the Chairman is committed to finding answers by other means.
    • “The federal government mandated the use of CPT codes. This creates the potential for abuse in that if someone has to buy your product, you can charge them what you want,” said Dr. Cassidy. “There may be nothing wrong here, but we should get answers to make sure the CPT system is working for the American patient and for the American health care system.”
  • Beckers Hospital Review tells us,
    • “Nearly 4 million Medicare-eligible Americans face heightened risk of disrupted medication access as restructuring efforts by the U.S. Postal Service slow mail delivery in rural and underserved communities reliant on mail-order prescriptions, according to a Dec. 4 analysis from The Brookings Institution
    • “In 2024, USPS launched its Regional Transportation Optimization initiative, which consolidates mail processing into regional hubs. While the initiative aims to improve efficiency, early analyses suggest it has exacerbated delivery slowdowns in rural areas, according to the report.”
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services Dec. 9 issued a proposed rule that would make changes to the Increasing Organ Transplant Access Model beginning July 1, 2026. IOTA is a six-year mandatory model for certain kidney transplant hospitals that began July 1 of this year. To comply with statutory requirements, CMS proposes to modify the eligible kidney transplant hospital criteria to exclude Department of Veterans Affairs medical facilities and military medical treatment facilities. The agency also proposes to raise the low-volume threshold from 11 kidney transplants performed annually during each of the baseline years to 15. Regarding IOTA participant performance, CMS proposes updates to the composite graft survival rate metric, including adding a risk-adjustment methodology that includes several transplant recipient and donor characteristics. In addition, CMS proposes other policy changes related to repayments, the extreme and uncontrollable circumstances policy, transparency and public posting of information, voluntary health equity plans, beneficiary protections, monitoring activities, and remedial actions and termination.” 
  • Modern Healthcare relates,
    • “Health insurance companies spent two years getting ready for a new Medicare Advantage quality metric intended to tackle health disparities. Then the government pulled the plug.
    • “The Excellent Health Outcomes for All measure — also known as EHO4All and formerly known as the health equity index— likely won’t be part of the Medicare Advantage Star Ratings program in 2027 after all, the Centers for Medicare and Medicaid proposed in a draft regulation last month.
    • “It’s a mixed bag for the insurance sector. In conjunction with implementing EHO4All, CMS also planned to scrap the Star Ratings program’s so-called reward factor, which benefits companies that demonstrate high quality scores over multiple years. But other companies stood to gain from an emphasis on health equity. 
    • “Moreover, the industry at large carried out intensive preparations to boost their performance on EHO4All measures, which were intended to boost insurers that cover large numbers of beneficiaries who qualify for both Medicare and Medicaid, are eligible for low-income subsidies, or have disabilities.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “The FDA has launched a safety review of approved respiratory syncytial virus therapies for infants, including Beyfortus from Sanofi and AstraZeneca and Enflonsia from Merck, Reuters reported Dec. 9.
    • “Senior executives from the three companies were informed last week that the agency would seek further data on the therapies following internal concerns raised by FDA officials appointed under Health and Human Services Secretary Robert F. Kennedy Jr. Tracy Høeg, MD, PhD, recently namedacting director of the FDA’s Center for Drug Evaluation and Research, initiated the safety inquiry over the summer. As a noted vaccine skeptic, the appointment of Dr. Høeg has raised serious concerns among healthcare experts.”
  • Bloomberg Law lets us know,
    • “The FDA’s effort to curb high drug costs by accelerating approvals of cheaper medicines similar to expensive biologics will need other policy reforms to boost access to the biosimilars, drug pricing experts say. 
    • “The Food and Drug Administration is seeking to lower drug costs by simplifying the development of biosimilars, products that are highly similar to FDA-approved biologics, have no clinically meaningful differences, and can treat patients the same way. Biologics, such as AbbVie Inc.‘s blockbuster treatment Humira for rheumatoid arthritis and Merck & Co.‘s cancer medicine Keytruda, are complex drugs made from sources such as plant or animal cells. 
    • “Biosimilars are often available at a lower cost compared to biologics. While insurance varies for patients, the list price of Humira can run above $6,000 a dose. Amgen Inc.‘s Amjevita, a biosimilar to the inflammatory drug, can be purchased at either 55% or 5% below Humira’s list price.
    • “The FDA action, however, might not immediately yield patient access to the cheaper medicines without reforming other policies that seek to make biosimilars available upon approval, drug pricing experts say. Biosimilars often face hurdles before hitting the market, frequently due to patent litigation, agreements between drug companies to defer entry, and how they’re treated in health insurers’ prescription drug plans.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first approval achieved through this review pathway. The approval was completed in just two months, representing a major reduction of the review timeline for this type of application.
    • “Over the last few decades, America lost control of supply chains for key medicines we depend on. That chapter is over – we’re entering a new era of manufacturing here at home,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security.”
    • “The Augmentin XR application demonstrated clear alignment with the CNPV program’s national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing capacity at a U.S. facility. This approval will also help address antibiotic shortages in the U.S. that have plagued the healthcare system over the past two decades.”
  • and
    • “The U.S. Food and Drug Administration today approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “The FDA continues to exercise flexibility in the regulatory approach for rare diseases by considering all available data sources, including as appropriate data from expanded access programs, to facilitate the advancement of life-changing treatments while ensuring scientific requirements are satisfied.”
  • Per MedTech Dive,
    • “Sometimes, the line between medical and wellness products can blur. Regulators’ pushback on a blood pressure feature that Whoop incorporated into its wellness wristband illustrates the challenges wearables developers face as they add increasingly sophisticated features.
    • “Whoop received a warning letter from the Food and Drug Administration this summer after rolling out the blood pressure offering without regulatory authorization.
    • “The company has pushed back on the warning letter, however, arguing that blood pressure is a wellness feature. The FDA disagreed, saying blood pressure is inherently related to a medical diagnosis. 
    • “The FDA isn’t likely to concede on its challenge, experts said. Whoop’s skirmish with the FDA offers lessons on where to draw the line between wellness and medical features.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Justice Department is weighing a challenge to a deal between two of the largest companies offering software to small, independent pharmacies, as antitrust enforcers step up their focus on the health-care industry.
    • “The deal, which the companies didn’t publicly announce, involves the acquisition ofMicro Merchants Systems, the operator of pharmacy management software platform PrimeRx, by RedSail Technologies, said the people, who asked not to be named discussing a confidential matter. Micro Merchants is backed by TA Associates Management, while RedSail is the result of multiple acquisitions backed by investment firms including Francisco Partners. 
    • “Representatives of the companies met with DOJ antitrust chief Gail Slater in late November, said the people. Such meetings indicate significant government opposition to a deal, although they don’t always precede a federal lawsuit if the companies are able to make proposals that allay the agency’s concerns. Companies submit confidential filings to US authorities as part of a merger review process.”
  • STAT News relates,
    • “In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs.
    • “Skinny labeling refers to a process in which a generic drug company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.” * * *
    • “Doubts were raised about the maneuver, however, when the Supreme Court two years ago declined to hear an appeal of a lower court ruling, which questioned the practice. Now, this second case is being seen as a test for whether skinny labeling can survive as a way for generic companies to market medicines, according to legal experts following the issue.”
  • The Wall Street Journal brings us to date on Luigi Mangione’s evidence hearing in New York state court.

From the public health and medical / Rx research front,

  • ABC News reports,
    • “Concerns about the flu spreading in the U.S. are growing as the U.K. continues to see a spike in cases among children and young adults.
    • “The increased number of cases in the U.K., could be a predictor for the flu season in the U.S., according to ABC News chief medical correspondent Dr. Tara Narula.
    • “We know that England or other places can be a marker for what is going to happen here, because their flu season happens a few weeks earlier than ours,” Narula said on “Good Morning America” Monday, adding, “We have low numbers of cases so far but they are increasing.”
    • “Some hospitals are starting to implement flu season visitor restrictions, including the Detroit Medical Center and Children’s Hospital of Michigan, which are allowing, as of Monday, up to two visitors per patient and only those 13 years of age and older are permitted on inpatient hospital floors or in observation units.
    • “According to data from the Centers for Disease Control and Prevention, flu activity in the U.S. is up at least 7% in the last week, and so far, there have been nearly 2 million illnesses, 19,000 hospitalizations, and 730 deaths from the flu.”
  • The Green Science Policy Institute tells us,
    • “New research led by the California Department of Public Health and partners found that replacing foam-containing furniture made before 2014 would cut in half levels of certain harmful flame retardants in people’s bodies in just over a year. Published today in the peer-reviewed journal Environmental Pollution, the study is the first to show measurable health benefits from California’s 2014 furniture flammability standard update, which made it possible for manufacturers to comply without adding chemical flame retardants.
    • “Specifically, volunteers who swapped their old sofas and living room chairs for new, flame-retardant-free versions saw their blood concentrations of polybrominated diphenyl ethers (PBDEs) drop by half in just 1.4 years. Due to the overall declining use of these chemicals, levels in participants who did not replace furniture dropped as well, but two to four times more slowly. PBDEs are linked to cancer risk, hormone disruption, and neurodevelopmental effects. Epidemiological studies have shown that the average U.S. child has lost three to five IQ points from exposure to one PBDE. Further, a recent research paper estimated those with highest levels of this flame retardant in their blood had about four times the risk of dying from cancercompared with people with the lowest levels.
    • “This study shows that the update to California’s flammability standard not only changed what goes into furniture—it changed what goes into people’s bodies,” said co-lead author Kathleen Attfield, a Research Scientist Supervisor with the California Department of Public Health. “Through biomonitoring, we can assess how policy changes and consumer choices can work together to lower exposures to toxic chemicals.”
  • NBC News reports,
    • “Despite previous excitement around a potential link between GLP-1 drugs and a reduced risk of cancer, new research suggests the popular medications “probably have little or no effect” on a person’s risk of developing one of the 13 obesity-related cancers.
    • “The findings, published Monday in the Annals of Internal Medicine, may seem counterintuitive, said co-author Dr. Cho-Han Chiang, who conducted the study earlier this year as an internal medicine resident at Mount Auburn Hospital, a Harvard Medical School teaching hospital in Cambridge, Massachusetts.” * * *
    • “The new study has two major limitations, Chiang said. One is that none of the nearly 50 trials his team analyzed was designed to measure cancer outcomes.
    • “Dr. Kandace McGuire, chief of breast surgery at the Massey Comprehensive Cancer Center at Virginia Commonwealth University, said that might explain the counterintuitive nature of the findings.
    • “When you take a bunch of studies that weren’t looking at cancer risk and you throw them together, sometimes you find things that are contrary to what you would hypothesize,” said McGuire, who wasn’t involved in the research. “Some of that may be just the makeup of the studies, rather than the actual data itself.”
    • “From a cancer prevention perspective, I think more data is needed,” Chiang said, noting that there’s also a lack of data on GLP-1 usage among patients who already have cancer.”
  • Health Day points out,
    • “Laughing gas might live up to its name for people struggling with depression, a major new study says.
    • “Treatment with nitrous oxide can provide rapid relief for people with depression, especially those who aren’t helped by antidepressants, researchers reported recently in the journal eBioMedicine.
    • “This is a significant milestone in understanding the potential of nitrous oxide as an added treatment option for patients with depression who have been failed by current treatments,” senior researcher Dr. Steven Marwaha, an academic psychiatrist with the University of Birmingham in the U.K., said in a news release.
    • “This population has often lost hope of recovery, making the results of this study particularly exciting,” Marwaha added.”
  • Today was the last day of the 2025 American Society for Hematology conference.
    • Per BioPharma Dive,
      • “A regimen involving Johnson & Johnson’s dual-acting drug Tecvayli could be curative when used early in the disease course of people with multiple myeloma, according to data disclosed Tuesday.
      • “Released at the annual meeting of the American Society of Hematology in Orlando, the results come from a trial called MajesTEC-3. J&J in October claimed early success for the study, which evaluated Tecvayli alongside another J&J drug called Darzalex, against Darzalex and a standard combination in people whose disease had advanced after one to three treatment lines. But it didn’t provide specific details, saving them for a spotlighted presentation at ASH on Tuesday.
      • “According to those results, the Tecvayli-Darzalex combination cut the relative risk of disease progression or death by 83% when compared to Darzalex and other therapies. Progression was also uncommon for treatment recipients who went six months without relapsing. According to J&J, 90% of those enrollees were still progression-free three years after the study’s start, leading researchers to suggest the combination could have curative potential.
      • “The efficacy is truly remarkable with this combination,” said Surbhi Sidana, an associate medical professor at Stanford University and a trial investigator. “We can see a light at the end of our tunnel with all of these therapies for our patients, having maybe a functional cure in the future.”
  • BioPharma Dive adds,
    • “An experimental Novartis drug helped bring an autoimmune condition causing low platelet counts under control in a Phase 3 trial, further lifting the prospects of a therapy the company acquired in a multibillion-dollar deal last year.
    • “The drug, ianalumab, acts by destroying misfiring immune cells and blocking signaling that creates new ones. Novartis has been testing it in a disorder called immune thrombocytopenia, in which the body erroneously wipes out blood-clotting platelets. The company intends for the drug to work hand-in-hand with another therapy, Promacta, that it sells for the condition.”

From the U.S.healthcare business front,

  • Fierce Healthcare reports,
    • “Healthcare giant CVS Health boosted its outlook for the year as part of its investor day on Tuesday.
    • “The company said it now expects full-year revenues of at least $400 billion and earnings per share (EPS) between $6.60 and $6.70. Previous estimates projected at least $397.3 billion in revenue and EPS of $6.55 to $6.65.
    • “CVS also projects its compound annual growth rate to be in the mid-teens for the next three years, reflecting the efforts it’s made to improve performance at multiple units. For example, CVS said it’s on track to return to target margins at Aetna, and it’s driving sustained earnings at CVS Pharmacy.
    • “We are closing out 2025 with meaningful momentum across our businesses and we expect another year of strong earnings growth in 2026,” said Chief Financial Officer Brian Newman in a press release. “We are committed to doing what we say.”
  • Fierce Pharma tells us,
    • “Eli Lilly has unveiled the location of the third of its four large-scale manufacturing facilities that it plans to build in the U.S.
    • “The drugmaker has selected Huntsville, Alabama, as the site of a $6 billion plant that will produce active pharmaceutical ingredients (APIs) for peptide and small-molecule medicines, including the highly anticipated GLP-1 weight-loss pill, orforglipron.
    • “Lilly plans to employ 450 at the complex, including engineers, scientists, operations personnel and lab technicians. The Indianapolis-based company expects to begin construction in 2026 and complete the facility in 2032. Lilly estimated that the project will also generate 3,000 construction jobs.”
  • Beckers Hospital Review informs us,
    • “Pfizer has entered into a global collaboration and license agreement with YaoPharma for the development, manufacturing and commercialization of YP05002, a small-molecule GLP-1 receptor agonist currently in phase 1 development for chronic weight management.
    • “YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical Group, will complete the ongoing phase 1 clinical trial and grant Pfizer exclusive worldwide rights to further develop and commercialize the therapy, according to a Dec. 9 news release.
    • “Pfizer will pay $150 million upfront and may pay up to $1.935 billion in development, regulatory and commercial milestone payments, along with tiered royalties on sales if the therapy is approved.”
    • Fierce Health relates,
      • “Artificial intelligence was a key theme in a session on how digital tools are changing the payer industry at this year’s Fierce Health Payer Summit.
      • “The panel took place last Thursday at the annual event and was moderated by Staff Writer Emma Beavins. The panelists spoke about the importance of improving payer-provider relationships and the member experience through AI and data-sharing.
      • “Consumers are used to the convenience offered by platforms like Netflix and Amazon, yet healthcare is lagging. AI can help streamline the member experience, including by surfacing transparent pricing. Doing so carries a high return on investment, Brittany Poche, director of solutions at revenue cycle management company Norwood, said. “Having that whole transparency and that experience, that is going to really move us,” Poche said on the panel.”

    Midweek Update

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

    From Washington, DC

    • Fierce Pharma reports,
      • “The U.S. House of Representatives has given a unanimous thumbs-up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December of last year.
      • “Rep. Michael McCaul, R-Texas, introduced the legislation in February alongside support from five other Republican Congressmen and five Democrats. The bill now advances to a Senate vote.
      • “By strengthening incentives for pediatric drug development, restoring essential programs such as the FDA Rare Pediatric Disease Priority Review Voucher, and ensuring that life-saving therapies reach the children who need them most, we are making meaningful progress,” Rep. Gus Bilirakis, R-Fla., said in a release.”
    • The Government Accountability Office today published a report titled “Patient Protection and Affordable Care Act:Preliminary Results from Ongoing Review Suggest Fraud Risks in the Advance Premium Tax Credit Persist.”
      • “This report discusses the preliminary results of our work on fraud risk management in the advance premium tax credit—a subsidy that the government pays to insurance companies to make premiums more affordable for eligible Americans under the Affordable Care Act.
      • “So far, we’ve found that fraud risks have persisted since we first reported on this (2014-2016). For example, we were able to get subsidized insurance for fake enrollees. We also found some issues with enrollees’ Social Security numbers that could indicate identity fraud.
      • “The program’s fraud risks were last assessed in 2018, even though the program and its risks have since evolved.”
    • Similarly, on November 24, the U.S. Office of Personnel Management’s Office of Inspector General published a capstone report on the agency’s implementation of the Postal Service Health Benefits Program. One key issue regarding confirmation of dependent eligiblity remains open.
      • The FEHBlog’s internal control concern is that OPM fails to use the HIPAA 820 electronic enrollment roster transaction with FEHB and PSHB carriers. The HIPAA 820 transaction, whihc has been around since 2008, allows carriers to tell whether a particular enrollee is paying a premium and if so is paying the correct premium. Bear in mind that half of the FEHB enrollment is self only. The HIPAA 820 transaction will produces savings that would cover the cost of implementation.
    • FedWeed reminds us,
      • Flexible spending account “participants may carry over part of the account for use in the next year, so long as they have accounts for that following year. For unspent 2025 money carried into 2026, that limit is $660 (for unspent 2026 health care account money eligible to be carried into 2027, the limit will be $680).”
    • and
      • “Next Monday (December 8) is the last day of the current open season to enroll or change coverage for 2026 under the FEHB and PSHB health insurance programs and the FEDVIP vision-dental insurance program, or to newly enroll or re-enroll in the FSAFEDS flexible spending account program.”
    • Per an OPM news release,
      • “The U.S. Office of Personnel Management (OPM) today announced the release of a new mandatory training program, “Performance Management for Supervisors,” designed to equip federal supervisors with the essential skills needed to lead high-performing, engaged teams.
      • “The training, now available through the Federal Performance Management Toolkit focuses on an array of topics including employee recognition and awards, hiring and discipline, drafting effective performance goals, delivering meaningful feedback, and taking timely corrective action.”
    • Per an HHS news release,
      • “The U.S. Department of Health and Human Services (HHS) today announced strong actions to protect the rights of parents within the practice of pediatric medicine. HHS opened an investigation into a complaint that a Midwestern school illegally vaccinated a child with a federally provided vaccine without the parents’ consent by ignoring a religious exemption submitted under a state law. HHS also issued a Dear Colleague letter [PDF, 265 KB] reminding health care providers about federal law requiring them to provide parents access to their children’s health information. In addition, the Department directed the Health Resources and Services Administration (HRSA) to add a grant requirement stating that all funding recipients must comply with all applicable federal and state parental-consent laws for any services or care provided to minors at HRSA-supported health centers as a condition of receiving Health Center Program funds.”
    • The American Hospital Association News notes,
      • “The Centers for Medicare & Medicaid Services has updated its GitHub repository with new resources to help hospitals comply with changes to hospital price transparency requirements finalized in the Medicare hospital outpatient prospective payment system final rule for calendar year 2026.”
    • STAT News points out,
      • “A new health care advocacy group, which will represent the shrinking number of independent doctors in America, is launching Wednesday with an ambitious policy agenda.
      • “IndeMed, which expects to represent nearly 70,000 members at its launch, will take on a host of issues important to doctors wanting to resist the wave of consolidation in recent years, its leaders told STAT. The group’s agenda includes reducing the burden of prior authorization, promoting transparent and fair reimbursement from payers, encouraging new practice models, fighting consolidation, and reforming the No Surprises Act.
      • “The group, through its nonprofit and associated political action committee, will push for changes in Washington as well as in states, and plans to offer members a state-by-state advocacy playbook.”

    From the Food and Drug Administration front,

    • The Wall Street Journal reports,
      • “Former Food and Drug Administration commissioners said new vaccine standardsthreaten to put Americans’ health at risk and upend the agency’s scientific integrity.
      • “The 12 former FDA leaders criticized the agency’s actions under vaccine skeptic Health Secretary Robert F. Kennedy Jr., in a joint piece published by the New England Journal of Medicine Wednesday.
      • “The authors make up nearly all of the living former FDA commissioners and acting commissioners, including Dr. Scott Gottlieb, who served during President Trump’s first term, and Dr. Robert Califf, who helmed the agency during the Obama and Biden administrations. 
      • “The article takes aim at the FDA’s plans for new vaccine standards detailed by vaccine division director Dr. Vinay Prasad that the former leaders said would drastically change vaccine regulation and “undermine public interest.” 
      • “In an email to staff last week, Prasad said the FDA will change its annual flu vaccine framework and require companies to submit larger studies about the effects of administering several vaccines at once.” 
    • STAT News tells us,
      • “Tracy Beth Høeg, a top lieutenant to Food and Drug Administration Commissioner Marty Makary, will be the next leader of the Center for Drug Evaluation and Research, according to an announcement from the FDA.
      • “CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective,” Høeg said in a statement. “This is an incredible opportunity to serve my fellow Americans.”
      • “Høeg’s appointment as the agency’s top drug regulator comes after director Richard Pazdur filed paperwork to retire at the end of the month.”
    • Healio points out,
      • “The FDA has approved an adeno-associated virus 9 gene replacement therapy to treat individuals aged 2 years and older with spinal muscular atrophy and a confirmed mutation of the survival motor neuron 1 gene, according to the manufacturer.
      • “In a press release, Novartis said the FDA’s approval positions Itvisma (onasemnogene abeparvovec-brve) as the first and only gene replacement therapy available to treat individuals with spinal muscular atrophy (SMA), a rare neuromuscular condition, virtually across the entire lifespan.”
      • “Itvisma is administered with a one-time fixed intrathecal dose that does not require adjustment based on a patient’s age or body weight, per the release. The drug is expected to be available within the U.S. in December.”

    From the public health and medical / Rx research front

    • The University of Minnesota’s CIDRAP relates,
      • “The Centers for Disease Control and Prevention (CDC) today confirmed 30 more measles cases reported in the United States this past week, raising the national total to 1,828 confirmed cases so far in 2025. 
      • “Current US hot spots are Utah, Arizona, and South Carolina, where outbreaks among predominately unvaccinated or under-vaccinated people have led to community spread and widespread quarantines at schools. 
      • “In total, the country has had 46 outbreaks this year of three or more cases; for comparison, 16 outbreaks were reported during all of 2024.” 
    • Health Day tells us,
      • “As many as 1 in 4 breast cancers occur in women younger than 50, a new study has found.
      • “Among seven outpatient clinics in the New York region, 20% to 24% of breast cancers were found in women 18 to 49, according to results presented Monday at the Radiological Society of North America’s annual meeting in Chicago.
      • “This research shows that a significant proportion of cancers are diagnosed in women under 40, a group for whom there are no screening guidelines at this time,” researcher Dr. Stamatia Destounis, a radiologist with Elizabeth Wende Breast Care (EWBC)  in Rochester, New York, said in a news release.
      • “The U.S. Preventive Services Task Force recommends mammography every other year starting at 40 and continuing through age 74, researchers noted. 
      • “The American Cancer Society recommends annual mammograms starting at age 45, but added that women can choose to begin breast cancer screening as young as 40.”
    • MedPage Today reports,
      • “Vaccination against herpes zoster, or shingles, was tied to fewer deaths among people with dementia, an analysis of data in Wales showed.
      • “Dementia patients who received the live-attenuated zoster vaccine (Zostavax) had a 29.5 percentage point decrease (95% CI 0.6-62.9, P=0.046) in dementia-related deaths over 9 years, reported Pascal Geldsetzer, MD, PhD, of Stanford University in California, at the annual Clinical Trials on Alzheimer’s Diseaseopens in a new tab or window (CTAD) annual meeting. The findings were published simultaneously in Cellopens in a new tab or window.
      • “Zoster vaccination also was tied to a drop of 3.1 percentage points (95% CI 1.0-6.2, P=0.007) in mild cognitive impairment cases during that period, Geldsetzer added.
      • “Our findings suggest that the live-attenuated herpes zoster vaccine has a beneficial effect at both ends of the disease course of dementia,” he said.
      • “They also hint that the shingles vaccine might slow dementia progression, he noted.”
    • BioPharma Dive reports,
      • “Data from a closely watched study evaluating Bristol Myers Squibb’s mind-stabilizing medicine Cobenfy in patients with Alzheimer’s disease could now come a year later than expected.
      • “In late July, Bristol Myers executives said they were reviewing the company’s near-term clinical trials to ensure the “timely delivery” of results with the “highest probability of success.” The review included “ADEPT-2,” a late-stage experiment exploring whether Cobenfy, which is already used to treat schizophrenia, may also have positive effects on the moderate to severe psychosis that often accompanies Alzheimer’s.
      • “On Wednesday, Bristol Myers disclosed that it had identified “irregularities” in the way the study was conducted at a “small number” of sites. This discovery prompted the company to not only exclude patient data from those sites for the study’s primary analysis, but, after consulting with the Food and Drug Administration, also bring in an “independent party” to assess the data that had been collected.
      • “Based on that party’s findings, a data monitoring committee recommended the trial keep going and enroll more participants so as to hit its original target. Bristol Myers is following this advice. ADEPT-2 had recruited around 400 patients across 119 locations, according to its listing on a federal database of clinical trials.
      • “The company now expects results to come by the end of 2026.”
    • and
      • “Pharvaris said Wednesday its pill for the rare swelling disorder hereditary angioedema succeeded in a Phase 3 trial, helping to begin relieving symptoms of an attack within 1.28 hours, significantly faster than a placebo.
      • “The Netherlands-based biotechnology company said it plans on asking the Food and Drug Administration in the first half of 2026 to approve deucrictibant. An extended release formulation of the medication is also in a Phase 3 trial to test whether it can prevent HAE attacks, with data expected next year.
      • “If approved, deucrictibant would be entering an increasingly competitive market. The first oral HAE drug to relieve attacks, Kalvista’s Ekterly, got an FDA nod this year, while two injectable drugs, including one to relieve attacks, also recently launched.”

    From the U.S. healthcare business and artificial intelligence front,

    • Modern Healthcare lets us know,
      • ‘Startup health insurance company Curative has raised more than $150 million in a funding round that pushes the company’s value at about $1.28 billion.
      • “Curative works to address skyrocketing employer health insurance expenses as inflation, pricey drugs and chronic diseases drive up costs.
      • “The company expects 2026 to be its first profitable year since the pandemic, and projects $570 million in revenue for this year.” * * *
      • “Curative’s approach differs from typical insurers. It eliminates cost-sharing like copays and deductibles for care in its network, as long as members complete an annual visit with a primary care provider and a “navigator” who guides their care, said Fred Turner, the company’s co-founder and chief executive.”
    • and
      • “Direct-to-consumer telehealth company Hims & Hers Health said Wednesday it has agreed to acquire YourBio Health, a medical device company that develops blood sampling technology.
      • “Financial terms of the transaction were not disclosed. 
      • “The deal is slated to close early next year pending customary closing conditions, according to a release.” * * *
      • “The acquisition will allow Hims & Hers to add YourBio Health’s TAP device, which uses smaller, thin needles to collect capillary blood samples in a way that differs from traditional methods, into its offerings. 
      • “YourBIO CEO Paul Owen and Chief Scientific Officer Dr. Michael Mina will join Hims upon completion of the deal, the company announced.”
         
    • The American Hospital News tells us,
      • “The AHA Dec. 3 released its 2026 Health Care Workforce Scan — an annual snapshot of America’s hospital and health system employment based on reports, studies and other data sources from leading organizations and researchers. It also offers insights and strategies from peers and experts on navigating the future of the health care workforce.”
    • Beckers Hospital Review identifies five health systems launched this year.
    • Per MedCity News,
      • “Samsung Healthcare unveiled a new ultrasound system this week designed to boost diagnostic accuracy and efficiency. 
      • “The system, named the R20, finally brings the full weight of Samsung Electronics’ AI and semiconductor capacity into an ultrasound platform, said Tracy Bury, chief commercial officer and vice president of global growth initiatives at Samsung Healthcare during an interview Tuesday at the Radiological Society of North America’s annual conference in Chicago.
      • “The R20 system pairs Samsung’s imaging hardware with improved beamforming software, which helps produce sharper, more consistent images, she stated. It supports a wide spectrum of imaging use cases, such as abdomen, thyroid, musculoskeletal, vascular, breast, gynecology and urology.” 
    • “MedTech Dive discusses “PitchBook: AI tuck-in deals to drive M&A acceleration in 2026. Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.”
      • “The medtech industry is approaching 2026 in an improving position, with investors increasingly optimistic and funding rebounding, PitchBook said in its outlook for next year.
      • “PitchBook analysts said strategic investors are targeting companies that are approaching clinical milestones in cardiology, orthopedics and diagnostics. The analysts named neurostimulation, artificial intelligence-powered surgical navigation and precision medicine as other top areas to watch.
      • “Tariffs on China-sourced components are a manageable, persistent headwind, the analysts said, but the potential for more levies is a risk. PitchBook sees Medline’s planned initial public offering as a strong indication that tariff uncertainties are now less top of mind.”

    Tuesday Report

    David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–

    From Washington, DC

    • The American Hospital Association News reports,
      • “President Trump Dec. 1 signed the AHA-supported SUPPORT Act (H.R. 2483) into law. The legislation reauthorizes key prevention, treatment and recovery programs for patients with substance use disorder. It also includes programs to support the behavioral health workforce.”
    • and
      • “The House Dec. 1 passed the Hospital Inpatient Services Modernization Act (H.R. 4313), legislation extending certain Medicare waivers authorizing the hospital-at-home care program for five years. The AHA expressed support for the bill in September.” 
    • The House Oversight and Government Reform Commitee posted a wrap-up concerning the mark-up session held today and mentioned in yesterday’s FEHBlog.
    • Fierce Healthcare tells us,
      • “Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy, M.D., is doubling down on his scrutiny of the American Medical Association’s (AMA’s) handling of billing and claims processing codes, telling the professional organization this week that it dodged several of the questions he posed on pricing and other topics back in October.
      • “The senator, a Republican from Louisiana and Congress’ most prominent healthcare legislator, has been putting the screws on the professional association for, in his words, “abusing” its widely adopted Current Procedural Terminology (CPT) coding system with “exorbitant fees” that drive higher healthcare costs.” 
    • The American Hospital Association News informs us,
      • “The Centers for Medicare & Medicaid Services Dec. 2 repealed the minimum staffing requirements for nursing homes that participate in Medicare and Medicaid that the agency adopted in 2024. Specifically, CMS is removing the requirements for nursing homes to provide a minimum of 3.48 hours of nursing care per resident day, including 0.55 hours of care from a registered nurse per resident day and at least 2.45 hours of care from a nurse aide per resident day. The agency is also removing the requirement for nursing homes to have 24/7 onsite RN services and is reinstating its prior policy requiring facilities to use the services of an RN for at least eight consecutive hours a day, seven days a week and to designate an RN to serve as the director of nursing on a full-time basis except when waived. The facility assessment requirements adopted in the 2024 final rule will remain in place. CMS’ actions are consistent with the budget reconciliation bill enacted in July, which imposed a 10-year implementation and enforcement moratorium on the minimum staffing requirements for long-term care facilities.”
    • Fierce Healthcare points out,
      • “As vaccine policy uncertainty reaches a new level in the U.S., the Centers for Disease Control and Prevention’s (CDC’s) team of vaccine advisors is set to deliberate later this week on childhood immunizations under a new chairman. 
      • “The Advisory Committee on Immunization Practices (ACIP), which was overhauled and repopulated by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. over the summer, is set to meet Dec. 4 and Dec. 5. 
      • “On the agenda (PDF) is a vote on hepatitis B vaccines plus discussions on “vaccine safety” and “the childhood and adolescent immunization schedule,” according to a Federal Register notice.” * * *
      • “Stepping up the plate as chairman of the ACIP is Kirk Milhoan, M.D., Ph.D., a pediatric cardiologist and former U.S. Air Force flight surgeon. Milhoan, one of five new ACIP panelists added to the roster in September, is a senior fellow with the Independent Medical Alliance (IMA) who specializes in treating patients with long COVID and “vaccine-related cardiovascular toxicity,” according to his IMA bio.”

    From the Food and Drug Administration front,

    • Fierce BioTech reports,
      • “Mere weeks after being named the nation’s top drug regulator, Richard Pazdur, M.D., is taking steps to retire as head of the FDA’s Center for Drug Evaluation and Research, an FDA spokesperson confirmed to Fierce Biotech.
      • “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” the spokesperson said. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.”
      • “Pazdur has filed papers to retire at the end of this month and informed FDA colleagues of his decision at a Tuesday meeting, according to a report from Stat News.”
    • Per an FDA news release,
      • “The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at roughly $1 million—from three firms in Missouri.
      • “The seizure focused on foods and dietary supplement products—including liquid shots and tablets—containing concentrated 7-OH as an added ingredient. Concentrated 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. It cannot be lawfully added to dietary supplements or conventional foods. These products are considered adulterated because 7-OH does not meet applicable safety standards. Also, the FDA has not approved 7-OH for medical use.
      • “This enforcement action is a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We must be proactive and vigilant to address emerging threats to our communities and our kids.”
    • Per MedTech Dive,
      • “BD has written to users of its Alaris pump modules about a risk associated with two complaints of serious injury.
      • “The Food and Drug Administration, which shared details of the letter Friday, has categorized the correction as a Class I recall because of the potential for serious injury or death.
      • “BD paid a $175 million civil penalty last year to settle charges that it misled investors about problems with its Alaris infusion devices and in September recalled pumps with variable performance.” 
    • and
      • “Cleveland Diagnostics said Monday it received Food and Drug Administration approval for a test that analyzes the structure of protein biomarkers in the blood for prostate cancer signals, to aid in determining whether a biopsy is needed.
      • “The IsoPSA technology is for men aged 50 and older whose results from a traditional prostate-specific antigen blood screening showed elevated PSA levels.
      • “Elevated PSA levels can be a sign of prostate cancer, but may be caused by other conditions. The IsoPSA test can help clarify whether a patient with an elevated PSA should have a biopsy procedure or can extend the interval between biopsies, Cleveland Diagnostics Chief Commercial Officer Bob Rochelle said in an interview.”

    From the judicial front,

    • Thompson Reuters notes,
      • “The Ninth Circuit has vacated a trial court’s ruling that an insurer acting as a third-party claims administrator (TPA) for self-insured health plans violated Affordable Care Act (ACA) Section 1557 when it administered discriminatory plan exclusions of coverage for gender-affirming care.” * * *
      • “On appeal, the Ninth Circuit ruled that the trial court correctly concluded that the TPA’s provision of health insurance is a health program or activity, part of which is receiving federal financial assistance, and that TPAs can be liable for violating Section 1557 even when implementing plan terms drafted by a plan sponsor. However, the Ninth Circuit ordered the trial court to reconsider its ruling that the gender-affirming care exclusions were discriminatory in light of the U.S. Supreme Court’s Skrmetti decision. (Skrmetti upheld a state’s ban on gender- affirming care for transgender teenagers, reasoning that the ban did not draw classifications based on sex— rather, it prohibited such treatments for certain medical uses with respect to all minors, regardless of sex or gender.) Although the trial court’s reasoning was undercut by Skrmetti, the Ninth Circuit noted that there may be factual distinctions in this case that distinguish it from Skrmetti, such as whether an individual was denied care for a diagnosis other than gender dysphoria or whether discrimination based on a gender dysphoria diagnosis is a pretext for “invidious discrimination” based on transgender status.”
    • The New York Times updates us about New York State’s prosecution of Luigi Mangione who is accused of murdering a United Healthcare executive last December.
      • “Prosecutors have said that Mr. Mangione had personal writings with him at the time in which he denounced America’s for-profit health care system and the “parasites” of the insurance industry. The police also found a journal by Mr. Mangione in his possession that described plans for an assassination, prosecutors said.
      • “Mr. Mangione’s lawyers have argued that the police violated his constitutional rights and so physical evidence taken from his backpack and statements he made at the time should be excluded.
      • “The hearings, which began Monday and are expected to last several days, are the first time Mr. Mangione has appeared in Manhattan state court since the judge overseeing the case, Gregory Carro, threw out terrorism charges against him in September. He still faces second-degree murder and other charges, and if convicted, he could receive a sentence of 25 years to life. Mr. Mangione also faces a federal prosecution.”

    From the public health and medical / Rx research front,

    • Cardiovascular Business reports,
      • “Abdominal obesity—the phenomenon commonly known as “beer belly”—is associated with significant cardiovascular risks, according to new data being presented at RSNA 2025 in Chicago.
      • “Abdominal obesity, a high waist-to-hip ratio (WHR), is associated with more concerning cardiac remodeling patterns than high body mass index (BMI) alone,” lead author Jennifer Erley, MD, a radiology resident at University Medical Center Hamburg-Eppendorf in Germany, said in an RSNA statement. “It appears to lead to a potentially pathological form of cardiac remodeling, concentric hypertrophy, where the heart muscle thickens but the overall size of the heart doesn’t increase, leading to smaller cardiac volumes. In fact, the inner chambers become smaller, so the heart holds and pumps less blood. This pattern impairs the heart’s ability to relax properly, which eventually can lead to heart failure.”
    • Health Day relates,
      • “People with severe asthma often take daily steroid medications to help prevent attacks, yet the drugs can bring about serious side effects. Is there another way?
      • “In a new trial, researchers examined how much an add-on treatment, already approved in the United States and United Kingdom, for severe asthma helped people with their symptoms and need for steroid pills.
      • “They found that an injected antibody called tezepelumab allowed 90% of people with severe asthma to reduce their use of daily steroids — and half of patients who received the injection were able to stop taking steroid pills altogether.
      • “Two-thirds of participants in the year-long trial also saw their asthma attacks disappear.
      • “This is an incredibly encouraging development for the future of asthma care that could transform the lives of people with severe asthma,” said Samantha Walker, who directs research at Asthma + Lung UK, a nonprofit advocacy group for people with asthma.”
    • and
      • “Tea, coffee, berries, cocoa, nuts, whole grains, olive oil: They’re all rich in antioxidant compounds called polyphenols, and they’re all good for your heart, a new British study shows.
      • “This research provides strong evidence that regularly including polyphenol-rich foods in your diet is a simple and effective way to support heart health,” said study lead author Yong Li, a PhD candidate in nutrition at Kings College London.
      • “As her team explained, polyphenols are natural compounds that have long been known to be beneficial for heart, brain and gut health.”
    • Per MedPage Today,
      • “A phase III trial of investigational valiltramiprosate (ALZ-801) did not meet its primary endpoint in people with early symptomatic Alzheimer’s disease, but the drug did show benefits in a prespecified population with mild cognitive impairment who carried two copies of APOE4.“
    • and
      • “An mRNA influenza vaccine was approximately 35% more effective than an inactivated quadrivalent flu vaccine against two different strains, based on new data from a phase 3 randomized trial.” * * *
      • “The new data provide compelling evidence that the mRNA platform may protect against influenza, which could be meaningful for future use for both seasonal and pandemic influenza, if warranted, [Kelly] Lindert [M.D., a Pfizer employee] said.
      • “The investigators have identified areas to refine the mRNA influenza vaccine, and they are working to evaluate these candidates in ongoing studies, Lindert told Medscape Medical News. “Our long-term goal is to develop an influenza vaccine that is broadly protective against influenza A and B strains, including protection against severe influenza in children through elderly adults,” she said.”

    From the U.S. healthcare business and artificial intelligence front,

    • McKinsey and Co. explains why “US healthcare organizations should rethink care and business models in response to substantial economic pressures and evolving care demands.”
      • “To address these cost and acuity challenges, healthcare stakeholders should continue to pursue innovative, outcome-focused care models that balance cost and care quality. Four archetypes of outcome-focused care models are in practice today. While these models have demonstrated promise, none have fully realized their potential. In this article, we delve into the value-creating opportunities within the four models:
        • “episodic models focused on shifting sites of care
        • “payer-led models focused on utilization, benefit, and care management
        • “primary care provider (PCP)–led models focused on risk-bearing, value-based care (VBC)
        • “specialty-led models focused on complex disease conditions.”
    • Adam Fein, writing in his Drug Channels blog, opines,
      • “Contrary to popular belief, the Inflation Reduction Act’s (IRA) maximum fair prices (MFPs) could temporarily boost profits for retail pharmacies serving Medicare Part D patients. 
      • “The bad news? The IRA is also one of the five key forces deflating the gross-to-net bubble. 
      • “That’s why any IRA-related pharmacy profits will vanish if manufacturers lower list prices to be closer to net prices. At least 13 brand-name drugs—five of which have MFPs—reportedly plan to reduce list prices within the next two months.
      • “[R]etail pharmacies risk becoming collateral damage from significant deflation in the gross-to-net bubble for drugs subject to an MFP. Welcome to our bonkers healthcare system—where everyone wants lower prices, until they actually get them. 
      • “What’s more, list price cuts will reduce profits from 340B contract pharmacy operations, while weakening covered entities’ main objections to a 340B rebate model. Get ready for a 340B slowdown.”
    • MedCity News considers that “The healthcare industry is contending with a difficult question: how to properly wield AI without taking on too much risk? Inherent in this battle is the role of humans. Here’s how Merck’s chief data officer is viewing AI.” It’s an interesting interview.
    • Healthcare Dive reports,
      • “The share of family physicians working in rural areas decreased 11% from 2017 to 2023, according to a study published this month in the Annals of Family Medicine.
      • “The Northeast saw the greatest loss in rural family physicians over the study period at 15.3%, while the West lost just 3.2% of rural family doctors.
      • ‘The data adds to concerns about physician shortages nationwide. America is expected to need more doctors than ever by 2030 to care for aging Baby Boomers, yet physicians say they’re struggling to hire and retain qualified talent amid high levels of burnout.” 
    • Per Beckers Hospital Review,
      • “Franklin, Tenn.-based Community Health Systems has completed the sale of select ambulatory outreach laboratory assets to Labcorp for $194 million in cash.
      • “The deal includes certain assets of CHS-affiliated hospitals’ lab services in 13 states, such as patient service centers and in-office phlebotomy locations. CHS will retain and continue operating its inpatient and emergency department laboratories, including lab services for hospital-based care like imaging and pre-admission testing.
      • “Completing this transaction with Labcorp allows our health systems to focus on core services and improve the overall patient experience, aligning with our unwavering commitment to providing high-quality, accessible healthcare to our communities,” CHS President and Interim CEO Kevin Hammons said in a Dec. 2 news release. “Labcorp’s scale and investment in technology supports its ability to efficiently deliver outreach laboratory services to patients and healthcare consumers.”

    Monday report

    David Ermer–CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, No Surprises Act, OPM, U.S. Healthcare–

    From Washington, DC

    • Per a November 28, 2025, Congressional news release,
      • “Today, House Committee on Oversight and Government Reform Chairman James Comer (R-Ky.) announced a markup will take place on Tuesday, December 2 at 10:00am ET to consider a series of legislation to reform procedures in the federal workforce, to promote greater transparency, and bring accountability to federal agencies and the District of Columbia.
      • “The American people deserve a productive federal government that provides transparency and accountability across all agencies, processes, and procedures. The House Oversight Committee is dedicated to ensuring that Americans’ voices are not diluted and that they can be employed in the federal workforce without undue burdens and other hinderances. Working in tandem with President Trump’s mission to reform the federal government, the Committee will do its part to examine the efficiency of agencies’ operations and remove any barriers that prevent Americans from fully participating in them,” said Chairman Comer.” * * *
      • “The markup will be open and available to the public and press and will be livestreamed online at https://oversight.house.gov/.”
    • Beckers Health IT tells us,
      • “A bipartisan group of federal lawmakers has introduced a bill they say would extend the availability of healthcare AI to rural Americans and seniors.
      • “The Health Tech Investment Act would assign all FDA-approved AI-enabled devices a temporary payment classification for a minimum of five years, pending the sufficient collection of cost data and the issuance of a permanent CMS payment code.”
    • Bloomberg News informs us,
      • “The US Office of Personnel Management is ending a program that gives federal workers discounted college tuition. 
      • “OPM Director Scott Kupor said in a memo Monday that the office would cancel the Federal Academic Alliance at the end of the current academic term. The voluntary partnership between universities and the federal government offered special rates for government employees and their families.
      • “Kupor wrote that the program is outdated and rarely used, with less than 0.2% of the federal workforce participating. More agencies are offering their own training programs, he said.”
    • Politico adds,
      • “The Trump administration wants federal agencies to shuffle top civil servants to more effectively implement the president’s agenda.
      • “The head of the Office of Personnel Management on Monday issued guidance encouraging agency leaders to review their rosters of top civil servants known as the Senior Executive Service and to consider reassigning them to new posts.
      • “The guidance marks the Trump administration’s latest move to overhaul the federal workforce and its senior management. The administration says the move will help dislodge “entrenched” civil servants, but critics accuse the administration of exerting undue political influence over federal workers.”
    • The Congressional Research Service released a report offering its analysis of No Surprises Act Independent Dispute Resolution data for 2024.
      • “The year 2024 marks the first year in which the IDR process was operational throughout the year without suspension, since it first began accepting dispute submissions in April 2022. This report, building on a prior CRS report analyzing 2023 data on IDR operations, reviews and analyzes data made publicly available by the Departments of Health and Human Services, Labor, and the Treasury—pursuant to NSA requirements—regarding IDR operations in calendar year 2024. In general, the data show an IDR process that was still maturing in 2024, as the year saw significant increases in the use of the IDR process (relative to 2022 and 2023) by providers; a large increase in the number of determinations made relative to 2023 and improvements in the amount of OON emergency/nonemergency service dispute determinations made within the generally required 33 business days (though a majority of determinations were still made outside of that window); and continued notable increases in payment determination amounts in certain medical specialties.”
    • Per the American Hospital Association News,
      • “The Centers for Medicare & Medicaid Services Innovation Center will launch a new, outcome-aligned payment model for providers offering technology-supported care to individuals with Original Medicare for managing common chronic conditions. The Advancing Chronic Care with Effective, Scalable Solutions Model will focus on conditions such as high blood pressure, diabetes, musculoskeletal pain and depression. CMS said it will pay participants in fixed installments for managing patients’ qualifying conditions, with full payment tied to achieving measurable health outcomes. CMS will begin accepting applications for the 10-year voluntary model Jan. 12, 2026, with an initial deadline of April 1, 2026. The model will begin July 1, 2026.”
    • and
      • “The Centers for Medicare & Medicaid Services announced Dec. 1 that it intends to expand the Inpatient Rehabilitation Facility Review Choice Demonstration to include IRFs in Texas and California. The demonstration, which is currently active for IRFs in Alabama and Pennsylvania, subjects all Original Medicare IRF claims to either pre-claim or post-payment review. IRFs in Texas will need to select either pre-claim or post-payment review by Feb. 13, 2026, and the demonstration will begin March 2, 2026. IRFs in California will need to select pre-claim or post-payment review by April 14, 2026, and the demonstration will begin on May 1, 2026. The AHA has opposed this demonstration, indicating its unnecessarily burdensome nature, and will continue to encourage the agency to pause its expansion.” 
    • Per an HHS news release,
      • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Martin Kulldorff, Ph.D., as chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE).  Kulldorff recently chaired the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) and previously taught at Harvard Medical School. He is a biostatistician and epidemiologist with more than 200 peer-reviewed publications.
      • “ASPE serves as HHS’ in-house think tank, providing policy advice to the Secretary. It also leads special initiatives, coordinates departmentwide research and evaluation activities, manages major planning processes, and produces analyses and cost estimates for policy options across public health, health care, and human services.”
    • The Wall Street Journal reports,
      • “The U.K. will increase the net price paid for new patented medicines by 25% to avoid U.S. tariffs on pharmaceutical exports.
      • “The U.K. government will reduce the clawback tax on high-value drugs to 15% next year, down from as much as a quarter or more.
      • “The U.S. guaranteed zero tariffs for U.K. pharmaceutical exports for at least three years as part of the agreement.”
    • Bloomberg Law adds,
      • “A deal between President Donald Trump and Novo Nordisk A/S to slash Ozempic and Wegovy prices under a most-favored-nation plan will override the costs for the blockbuster drugs negotiated separately by the Medicare agency.
      • “Due to the terms and timelines of the negotiated deals, the MFN prices for covered GLP-1 drugs are expected to supersede the IRA prices,” a spokesperson for the Centers for Medicare & Medicaid Services said in an email Friday.” * * *
      • “The prices under the most-favored-nation plan are scheduled to launch in 2026, while the negotiated drug prices for the second were slated to run in 2027.”
    • Fierce Pharma further adds,
      • “On the heels of striking a deal with the Trump administration to reduce the prices of several of its most popular drugs for U.S. patients, Eli Lilly has unveiled additional savings for cash-paying users of its obesity and sleep apnea med Zepbound.
      • “In the early November announcement of its agreement with the government, Lilly pledged to reduce the self-pay price of Zepbound in multidose pen form—which has yet to be approved by the FDA. Once the approval is secured, the multidose pens will be available via the LillyDirect online pharmacy platform for $299 to $449.
      • “Monday’s announcement adds discounts to single-dose vials of Zepbound, which are already approved and available in the U.S. Self-paying patients prescribed the GLP-1 will now be able to access the vials at $50 to $150 off their previous prices on LillyDirect.”
    • Per Politico,
      • “Three blockbuster drugs will exit Medicare’s price negotiation program in 2027 after regulators determined they now face generic or biosimilar competition, according to a Centers for Medicare and Medicaid Services memo obtained by POLITICO.
      • “The removal means that Novartis’ chronic heart failure treatment Entresto, Janssen’s anti-inflammatory medicine Stelara, and Bayer and Janssen’s blood clotting drug Xarelto will no longer be subject to the negotiated price reached during the first cycle of Medicare drug price talks.”

    From the Food and Drug Administration front,

    • Per an FDA news release,
      • “The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees. Agentic AI capabilities will enable the creation of more complex AI workflows — harnessing various AI models — to assist with multi-step tasks.
      • “Agentic AI refers to advanced artificial intelligence systems designed to achieve specific goals by planning, reasoning, and executing multi-step actions. These systems incorporate built-in guidelines — including human oversight —to ensure reliable outcomes. The tool is entirely optional for FDA staff and is used voluntarily.  
      • “We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators,” said FDA Commissioner Marty Makary, M.D., M.P.H. “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.”
    • Beckers Hospital Review relates,
      • “Merck’s investigational antibody MK-2214 has received fast-track designation from the FDA for the treatment of Alzheimer’s disease.
      • “MK-2214 targets phosphorylated serine 413 tau (pS413), a marker of abnormal protein accumulation in the brain, according to a Dec. 1 news release from the company. The designation was announced alongside the first-in-human phase 1 trial data to be presented at the Dec. 1-4 Clinical Trials on Alzheimer’s Disease 2025 event in San Diego. The data supported dose selection for an ongoing phase 2 trial.”
    • The American Hospital Association News reports,
      • “The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through internal testing. The devices are being permanently recalled and the FDA advised customers to stop using the product. The FDA said unauthorized individuals could potentially change device therapy settings or access device data if it is left unattended, which could lead to the life-supporting air delivery function not working as intended.   
      • “In addition, the FDA identified Class I recalls of Becton Dickinson Alaris Pump Modules and Balt USA Mega Ballast Distal Access Platforms.”  

    From the judicial front,

    • The American Hospital Association New points out,
      • “The AHA, the Maine Hospital Association and four safety-net health systems from across the country Dec. 1 filed a lawsuit in the U.S. District Court for the District of Maine to challenge the 340B Rebate Model Pilot Program. The AHA and its co-plaintiffs are seeking a temporary restraining order to stop the rebate program from going into effect Jan. 1, 2026.
      • “If implemented, the program would impose overwhelming financial and administrative burdens on 340B hospitals, many of which already operate on razor thin margins while playing a vital role in their communities, often serving as the only source of care. The lawsuit alleges that the Department of Health and Human Services’ decision to move forward with the rebate program through a rushed, opaque process violates the most basic principles of administrative law, including by ignoring the concerns of over 1,000 340B hospitals and other stakeholders, many of which highlighted the significant costs and community impact of administering the rebate model.”

    From the public health and medical / Rx research front,

    • Genetic Engineering and Biotechnology News reminds us,
      • “World AIDS Day, first observed on December 1, 1988, is an international day to raise awareness of the global HIV/AIDS pandemic. Since its inception, the website notes, communities have stood together to show strength and solidarity against HIV stigma and to remember lives lost. 
      • “As of 2024, over 40 million people in the world are diagnosed with human immunodeficiency virus (HIV)—a chronic, life-threatening infection that remains one of the leading global causes of death. Today, we take a moment to reflect on the progress made in the global fight against HIV, while recognizing the challenges that remain.”
    • The Washington Post reports,
      • “A small, highly anticipated study shows a glimmer of hope in the long effort to control HIV without medication and search for a cure for a virus that attacks immune cells.
      • “Researchers gave 10 people with HIV a complex regimen of experimental immunotherapies, then discontinued the daily pills that kept the virus at bay. In six participants, the virus rebounded slowly and stayed at a low level for months, and one person’s immune system kept the virus in check for more than a year and a half — giving scientists hope that they could optimize the approach to create a cure.
      • “It’s provocative, but I’ve been doing treatment interruption studies for 30 years, and this is unexpected and unparalleled,” said Steven Deeks, a professor of medicine at the University of California at San Francisco and one of the leaders of the study. He and other scientists were quick to caution that this is a promising step forward, not a solution. The small study did not include a control group, so more studies will be needed to confirm and flesh out the exciting signal.”
    • Healio tells us,
      • “From 2008 to 2023, there has been a significant decrease in cystic fibrosis mortality rates and a significant rise in sickle cell disease mortality rates in the U.S., according to findings published in JAMA Pediatrics.
      • “For frontline clinicians, these results are a call to action,” Nansi S. Boghossian, PhD, associate professor in the Arnold School of Public Health at the University of South Carolina, told Healio. “They highlight the barriers many patients with sickle cell disease face including limited access to proven therapies, under-resourced systems and the high costs of newer treatments.”
    • NBC News explains why “Doctors seek to understand why quitting antidepressants causes withdrawal for some. A “deprescribing” movement is building up in the psychiatry field, aimed at helping patients reduce or stop their medications when no longer considered necessary.”
    • MedPage Today informs us,
      • “Changes in driving frequency, complexity, and spatial range were associated with mild cognitive impairment in older adults.
      • “Trip distances, speeding, and destination variability distinguished mild impairment from normal cognition with strong predictive accuracy.
      • “Continuous, real-world driving data may signal impairment before safety events occur, researchers suggested.”
    • The American Medical Association lets us know what doctors wish their patients knew about end of life care planning.
    • Per Health Day,
      • “About half of people who die by suicide show no prior warning signs.
      • “Many do not have mental health diagnoses or genetic psychiatric risks.
      • “Researchers hope to improve how doctors screen for suicide risk.”
    • Per BioPharma Dive,
      • “An experimental drug from Belite Bio succeeded in a Phase 3 trial in the most common form of Stargardt disease, positioning the company to seek regulatory approval next year of what could be the first marketed medicine for the condition.
      • “According to Belite, treatment with its drug, known as tinlarebant, was associated with a roughly 36% reduction in the growth rate of retinal lesions compared to a placebo over the course of two years, meeting the trial’s main goal. Both study groups had a minimal overall change in visual acuity, but Belite said that finding was “consistent” with historical data.
      • “Belite said tinlarebant was “well tolerated,” with only four patients stopping treatment due to adverse events. The most common eye side effects related to treatment were a type of color vision deficiency and issues seeing at night or adjusting to a dark environment. The majority of those cases were mild, and most resolved during the trial, the company said.”

    From the U.S. healthcare business and artificial intelligence front,

    • Fierce Healthcare identifies its ten Women of Influence for 2025. Congrats to these ladies.
    • Fierce Healthcare adds,
      • “As healthcare providers increasingly adopt artificial intelligence tools, researchers, physicians and health tech companies are moving quickly to assess the verifiable impact of these technologies.
      • “Early studies looking at the use of AI tools, such as ambient scribes, among physicians are showing promising results. The use of AI scribes leads to lower burnout and lighter cognitive load for users, plus measurable cuts in documentation time, according to recent studies.
      • “Primary care doctors are also reporting that AI features embedded in the electronic health record (EHR) are helping them provide higher-quality care, according to a new survey from Elation Health.”
    • STAT News adds,
      • “The biggest radiology practice in the United States is leaning even further into artificial intelligence. The tech arm of Nashville-based Radiology Partners, which includes more than 4,000 radiologists reading more than 55 million images every year, last month acquired a new AI company for $80 million: Cognita Imaging, a Stanford researcher-founded startup that’s hoping to win the race to capitalize on foundation models in radiology.
      • “By training vision-language models on large numbers of radiological images and their written radiology reports, the hope is that AI will be able to read an X-ray or CT scan like a radiologist would: Not just by looking for a single, predetermined abnormality, but for any finding that looks important. Many existing and new radiology companies have launched themselves at that goal, despite concerns about whether such broadly-targeted technology can be validated and used safely.”
    • Beckers Health IT notes that
      • “Hospital-at-home treatment could be one way to “solve the rural healthcare crisis,” researchers from Somerville, Mass.-based Mass General Brigham say.”
    • and
      • “EHR vendors have expanded their patient-record sharing capabilities in recent years, but clinicians still report little improvement in how usable that data is, a Dec. 1 report from KLAS Research found.
      • “The report examines provider-to-provider record exchange, third-party application integration and payer-provider data sharing.”
    • Beckers Hospital Review tells us,
      • “Estes Park (Colo.) Health officially joined Aurora, Colo.-based UCHealth Dec. 1 as UCHealth Estes Valley Medical Center.
      • “This not only gives us financial stability and additional access to resources and subject matter experts, but also assistance in recruiting and retaining staff and providers, and importantly, continued access to healthcare for our patients,” Vern Carda, president of Estes Valley Medical Center, said in a news release.” 
    • BioPharma Dive informs us,
      • “Regeneron Pharmaceuticals is putting more money into gene editing, announcing Monday a partnership with Tessera Therapeutics to develop an experimental program for a rare liver and lung disease. 
      • “At the center of the deal is a treatment Tessera, a well-funded startup backed by Flagship Pioneering, is developing for alpha-1 antitrypsin deficiency. Regeneron is paying Tessera $150 million upfront, in the form of cash and an equity investment, to collaborate on the program and split future development costs and profits. Tessera could receive another $125 million in unspecified near and mid-term development milestone payments.   
      • “Tessera will lead the initial first-in-human trial, with Regeneron taking the reins for future development and eventually commercialization.” 

    Weekend update

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

    From Washington, DC,

    • Roll Call offers a preview of these Capitol Hill activities.
    • The Centers for Medicare and Medicaid Services posted fact sheets on the following topics:

    From the public health and medical / Rx research front,

    • The New York Times reports,
      • “A recently recognized form of dementia is changing the understanding of cognitive decline, improving the ability to diagnose patients and underscoring the need for a wider array of treatments.
      • “Patients are increasingly being diagnosed with the condition, known as LATE, and guidelines advising doctors how to identify it were published this year. LATE is now estimated to affect about a third of people 85 and older and 10 percent of those 65 and older, according to those guidelines. Some patients who have been told they have Alzheimer’s may actually have LATE, dementia experts say.
      • “In about one out of every five people that come into our clinic, what previously was thought to maybe be Alzheimer’s disease actually appears to be LATE,” said Dr. Greg Jicha, a neurologist and an associate director of the University of Kentucky’s Sanders-Brown Center on Aging.
      • “It can look like Alzheimer’s clinically — they have a memory problem,” Dr. Jicha said. “It looks like a duck, walks like a duck, but then it doesn’t quack, it snorts instead.”
    • The Washington Post relates,
      • “Vaccines don’t just shield you from specific infectious diseases or help make symptoms less severe if you get sick but can also prevent common chronic illnesses, including some cancers, according to public health experts.
      • “We now have a more full understanding of how these vaccines go beyond just protecting us against the disease that they helped prevent,” said Richard Martinello, chief medical officer and infectious diseases physician at Yale School of Medicine.
      • “In addition to cancer, a growing body of research has shown that vaccines can reduce the risk of developing dementia and heart conditions. Vaccines can also help people with existing chronic conditions avoid getting sicker.”
      • The article identifies the common vaccines experts recommend
        • HPV
        • Shingles
        • Hepatitis B
        • Flu, coronavirus and RSV,
        • Bacterial vaccines
    • The Wall Street Journal reassures us,
      • “Why does a glass of wine make a holiday party feel more festive? It might be because our forebears used to party.
      • “Not the ancient Greeks, though they did name a god of wine. Go back even further than that—some 50 million years further, when our primate ancestors began seeking out fermented fruits that naturally contained ethanol, scientists say.
      • “Those that could sniff out ethanol (or alcohol)—which gives off an odor, as we all know from the smell of a beer hall—were rewarded with a tasty nutritional gold mine: plant carbs and calorie-rich ethanol.
      • “All primates can metabolize ethanol, mining it for energy. But research that examined enzymes from ancestral primates indicated that around 10 million years ago, a digestive enzyme mutation allowed African apes—including the common ancestor of humans, gorillas and chimpanzees—to metabolize that alcohol 40 times more efficiently than other primates.
      • “The change made it even more beneficial to be able to find and consume alcohol in the wild, according to Nathaniel Dominy, a professor of anthropology at Dartmouth College.
      • “Fast forward to the advent of agriculture roughly 10 millennia ago, and humans began making alcohol intentionally in large and potent quantities. Today, of course, we have wide access to it.
      • “It’s been argued that the whole reason we domesticated cereals in the first place was to make beer, not bread,” Dominy said. “Our brains are wired to like it.”
    • Medscape points out,
      • “Among patients with obesity and type 2 diabetes (T2D), those who underwent metabolic bariatric surgery experienced greater weight loss and reductions in A1c levels than patients who did not undergo surgery.” * * *
      • “These results support current clinical guidelines that recommend metabolic bariatric surgery for individuals with severe obesity or obesity-related complications who do not achieve adequate results through more conservative treatments,” the authors of the study wrote.”

    From the U.S. healthcare business and artificial intelligence front,

    • Beckers Health IT reports,
      • “Amazon plans to invest up to $50 billion to ramp up AI and supercomputing capabilities for federal agencies, boosting healthcare research and pharmaceutical breakthroughs.
      • “The tech giant intends to break ground on the data centers in 2026, providing Amazon Web Services’ U.S. government customers with an additional 1.3 gigawatts of AI and supercomputing capacity.
      • “We’re giving agencies expanded access to advanced AI capabilities that will enable them to accelerate critical missions from cybersecurity to drug discovery,” Amazon Web Services CEO Matt Garman said in a Nov. 24 news release. “This investment removes the technology barriers that have held government back and further positions America to lead in the AI era.”
    • and
      • Best Buy took a $192 million accounting loss after ending its hospital-at-home partnerships with health systems.
      • The tech retailer recorded the pretax, noncash asset impairments related to Best Buy Health in the third quarter of fiscal 2026, according to a Nov. 25 earnings report.
      • “The impairments were prompted by a change in Best Buy Health’s customer base during the quarter and reflect downward revisions in our long-term projections, in part due to pressures in the Medicaid and Medicare Advantage markets,” Best Buy CEO Corie Barry said in a Nov. 25 earnings call.
    • Beckers Payer Issues identifies the “[t]en providers [which] recently posted job listings seeking leaders in payer contracting and relations.
    • HR Dive informs us,
      • “After a year of mass layoffs and uncertainty, 2026 could stabilize hiring trends and bring equilibrium to the U.S. labor market, according to a Nov. 18 report from HireQuest.
      • “In particular, the job market appears to be stabilizing around skills-based hiring, the report found. In addition, late 2025 layoffs could reset — but not reverse — the market, as well as spur employee reskilling and contract-based hiring.
      • “2026 won’t be defined by a hiring boom or a bust but by more balance,” Rick Hermanns, president and CEO of HireQuest, said in a statement. “We’re seeing a labor market that’s stabilizing around new priorities: flexibility, fit and the kind of skilled work that can’t be automated.”

    Friday report

    David Ermer–CMS, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–

    Delving into aspects of recent CMS Medicare rules,

    • Healthcare Dive reports,
      • “The CMS is proposing to overhaul the Medicare Advantage star ratings system, including by culling a dozen quality measures and removing a health equity reward. 
      • “In a proposed rule released Tuesday, the agency said it wanted to cut 12 metrics that focus on administrative processes where health plan performance is typically high and beneficiaries can’t easily distinguish between offerings, like customer service and appeal timeliness. Most of the cuts would go into effect in the 2029 star ratings. 
      • “The CMS is also proposing to not implement the Excellent Health Outcomes for All reward, designed to incentivize plans to improve care for enrollees who are low-income or disabled. Additionally, the agency wants to add a quality measure on depression screening and follow-up.”
    • Modern Healthcare tells us,
      • “A new Medicare policy on complex surgical procedures could drive a deluge of patients to outpatient facilities. But while some view the change as a win for beneficiaries and taxpayers, others see clinical risks.
      • “The Centers for Medicare and Medicaid Services will phase out the Medicare Inpatient-Only List over the next three years under the Hospital Outpatient Prospective Payment System final rule for 2026, which it published Friday. The first stage is allowing outpatient providers to bill for 285 musculoskeletal codes that currently are only reimbursable for inpatient hospitals.
      • “The Ambulatory Surgery Center Association welcomed the relaxed rules. “The elimination of the Inpatient-Only List provides Medicare beneficiaries the ability to work with their surgeon to best determine the appropriate site of care,” Chief Advocacy Officer Kara Newbury wrote in an email.
      • Similarly, the Medical Group Management Association believes this policy will enhance access and reduce costs, said Senior Vice President of Government Affairs Anders Gilberg.
      • Yet the American Hospital Association stands firmly against ending the Inpatient-Only List. “The AHA opposes CMS’ proposal to eliminate the [Inpatient-Only List] over three years. Instead, the AHA recommends that CMS continue with its standard process for removing procedures from the [Inpatient-Only List],” Ashley Thompson, senior vice president of public policy analysis and development, wrote CMS on Sept. 15.
      • “We are concerned that, given the depth and breadth of the 1,731 procedures on the [Inpatient-Only List], it would be reckless to eliminate them all,” Thompson wrote. “We are concerned that CMS is proposing a blanket policy to essentially remove all procedures without an examination of any safety or other implications.”
    • MedTech Dive informs us,
      • “The Centers for Medicare and Medicaid Services has finalized a payment policy that covers cardiac catheter ablation procedures in ambulatory surgery centers for the first time.
      • “The Heart Rhythm Society’s advocacy arm representing electrophysiologists called the final rule, which is effective Jan. 1, 2026, a milestone for the field. “This change expands Medicare beneficiary access to EP services and represents one of the most significant federal advancements in how and where EP care is delivered in more than two decades,” the group said. 
      • “Wall Street analysts said the new ASC reimbursement payment could boost atrial fibrillation procedure volumes, potentially benefiting Abbott, Boston Scientific, Johnson & Johnson and Medtronic.”

    From the public health and medical / Rx research front,

    • The Washington Post lets us know “Ozempic 2.0 is on the way, and it could be even more transformative. A new weight loss pill could come within months, and other experimental treatments with more potency are not far behind.”
      • “A new wave of the medicine is coming that could be even more transformative for human health: pills, more potent injectables and new compounds that might have fewer side effects or could be taken just once a month.
      • “With this newer generation of medications, we’re not just focusing on weight loss,” said David Lau, an endocrinologist and professor emeritus at the University of Calgary Cumming School of Medicine. “We’re talking about changes beyond what you see on the scale.”
    • NBC News relates,
      • “As we age, the human brain rewires itself. 
      • “The process happens in distinct phases, or “epochs,” according to new research, as the structure of our neural networks changes and our brains reconfigure how we think and process information.
      • “For the first time, scientists say they’ve identified four distinct turning points between those phases in an average brain: at ages 9, 32, 66 and 83. During each epoch between those years, our brains show markedly different characteristics in brain architecture, they say.
      • “The findings, published Tuesday in the journal Nature Communications, suggest that human cognition does not simply increase with age until a peak, then decline. In fact, the phase from ages 9 to 32 is the only time in life when our neural networks are becoming increasingly efficient, according to the research.”
    • Cancer Advisor points out,
      • “Overweight and obesity are both associated with a greater risk of developing pancreatic cancer by the age of 50 years, according to research published in the European Journal of Cancer.
      • “These findings indicate that even modest excess weight in early adulthood, including overweight and mild obesity, may represent an independent and modifiable risk factor for young-onset pancreatic cancer,” study researchers wrote.
      • “Although the incidence of pancreatic cancer among adults under the age of 50 years has risen in recent years, the risk factors driving young-onset pancreatic are not well defined, the researchers noted. In this study, they evaluated the dose-response relationship between body mass index (BMI) and the risk of developing pancreatic cancer by the age of 50 years.”
    • Per Medscape, “Chronic Gut Pain’s Elusive Cause Found — and Possibly Fixed.”

    From the U.S. healthcare business front,

    • Modern Healthcare reports,
      • “Health insurance mergers and acquisitions picked up in the third quarter as companies seek to gain scale, modernize operations and stay competitive in a difficult regulatory and cost environment. 
      • “Insurers announced 10 M&A deals during the third quarter, up from seven in the year-ago period, according to data compiled by the Levin Associates, and more have emerged during the fourth quarter.
      • “This month, MVP Health Care and Independent Health announced a deal, Medica proposed buying UCare’s exchange and Medicaid operations, and Cambia Health Solutions and Arkansas Blue and Cross and Blue Shield inked an agreement to affiliate.
      • “It definitely seems to have a new momentum behind it. Payers are definitely more active,” said Dan Farrell, a partner and health services deals leader at the consulting firm PricewaterhouseCoopers. “It’s accelerating at all levels, and I think that will continue through the end of 2025 and into the first half of ‘26.” 
    • McKinsey & Company evaluates the “Future of US healthcare: Gathering storm 2.0 or a golden age?”
      • “Health industry economics continue to be roiled in the postpandemic era, and the outlook for funding suggests continuing relentless pressure. Healthcare industry EBITDA as a proportion of national health expenditure (NHE) was 200 basis points lower in 2024 compared with 2019. From 2024 through 2027, it is expected to fall another 100 basis points, with marginal recovery expected by 2028 through targeted interventions, according to McKinsey research.
      • “Nonetheless, the potential opportunity from advances in AI, automation, efficient sites of care, medical science, and care model innovation is staggering. We estimate that the available improvement opportunity is 9 to 15 percent of NHE on a run-rate basis.1
      • “As always, the opportunity to improve healthcare outweighs the headwinds if healthcare leaders can unlock the transformation required to seize the opportunity.”
    • Fierce Healthcare informs us,
      • “Three drugs treating chronic conditions are set for Food and Drug Administration review by the end of the year, and a new report from Optum Rx digs into why payers should be watching these decisions.
      • “According to the report, the FDA is set to review an oral formulation of Novo Nordisk’s GLP-1 Wegovy as well as depemokimab, a drug that treats eosinophilic asthma, and remibrutinib, a therapy for chronic spontaneous urticaria under the brand name Rhapsido.
      • “Sara Guidry, senior director of pipeline and drug surveillance at Optum Rx, told Fierce Healthcare in an interview that these drugs target weight and chronic inflammatory conditions, both segments that are significant cost drivers for payers and plan sponsors.
      • “They are two topics we are consistently discussing with payers and clients,” Guidry said.”
    • and
      • “WellTheory, a virtual platform for autoimmune care, is partnering with Instacart to embed grocery stipends into its care model. The partnership addresses a critical gap in autoimmune care: access to nutritious, anti-inflammatory foods, according to the companies.
      • “By integrating Instacart’s Health Fresh Funds, more than 300,000 eligible WellTheory members can purchase clinically recommended groceries to support healthier nutrition decisions.
      • “Autoimmune patients often face significant barriers to accessing the right foods — from affordability and availability to the daily friction of turning dietary guidance into actionable shopping decisions. The new Instacart partnership supports WellTheory’s mission to fill the gaps left behind by traditional healthcare and provide whole-person care that addresses the root causes of autoimmunity, executives said.
      • “Instacart reaches more than 98% of U.S. households, including 95% of those located in food deserts and nearly 98% of households enrolled in SNAP, the grocery technology company said.”

    Tuesday report

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

    From Washington, DC,

    • The Hill reports,
      • “President Trump on Tuesday said he would prefer not to extend Affordable Care Act subsidies that are set to expire at the end of the year, but he acknowledged it may be necessary to reach an agreement on health care legislation.
      • “Trump, in response to a question from The Hill, told reporters his preference was to pass legislation that gave money directly to Americans to allow them to purchase their own health care plan.
      • “I like my plan the best. Don’t give any money to the insurance companies, give it to the people directly. Let them buy their own health care plan. And we’re looking at that. If that can work. We’re looking at that,” Trump said.
      • “Asked if he is planning to extend the Affordable Care Act subsidies that were at the heart of the government shutdown debate, Trump said he’d “rather not.”
      • “Somebody said I want to extend them for two years. I don’t want to extend them for two years. I’d rather not extend them at all,” Trump said. “Some kind of extension may be necessary to get something else done, because the un-Affordable Care Act has been a disaster.”
      • “Trump told reporters he was talking with Democrats about health care, but when asked who specifically, he would not say.”
    • Roll Call adds,
      • “The front-runner to be the next top Republican on the House Budget Committee is eyeing a potential second reconciliation bill that could include tax and health care provisions that were dropped from the GOP’s “big, beautiful” package last summer.
      • “Rep. Lloyd K. Smucker, R-Pa., the first entrant and heavy favorite in the race to succeed retiring Budget Chairman Jodey C. Arrington, R-Texas, said he would like to see an extension of the Work Opportunity Tax Credit as part of a future reconciliation bill.
      • “That credit goes to employers who hire individuals from groups that face barriers to employment, such as veterans, ex-felons and recipients of Supplemental Nutrition Assistance Program benefits, among others. The credit is set to expire at the end of this year.
      • “I think there were a number of pieces of tax policy that were not included in the bill that we did, and I’d love to see some of those provisions passed,” he said.
      • “Speaker Mike Johnson, R-La., has pushed to do a second — and even a third — reconciliation package before the midterm elections, although the contours of a follow-up bill are still far from clear. But President Donald Trump has said he believes the reconciliation law that he signed in July is sufficient and that additional legislation is not necessary.”
    • The Wall Street Journal relates,
      • “The U.S. government negotiated lower prices in the federal Medicare program for 15 high-selling medicines including Ozempic, widening an effort to rein in drug costs.
      • “The new prices, which will take effect in 2027, shave 38% to 85% off the list prices for drugs for diseases including asthma, cancer and diabetes. The reductions are estimated to save Medicare, the health-insurance program for the elderly, $12 billion.
      • “For some patients, the lower prices could reduce spending on copays or other out-of-pocket charges imposed by their particular plan. Other patients taking the drugs might not see a direct savings, however, because they have fixed monthly copays. 
      • “Also, Medicare members now have a $2,000 annual cap on out-of-pocket drug costs. Yet the savings could help curb growth in plan premiums.
      • “In addition to Ozempic, other drugs that will cost Medicare less thanks to the negotiations include GSK’s Trelegy asthma treatment, Pfizer’s breast-cancer therapy Ibrance and Merck diabetes pill Janumet—all of them huge sellers.
      • “The price cuts apply to Medicare, not to private health-insurance plans. Medicare spends more than $150 billion a year on prescription drugs, and the cuts will mean reduced revenue for drugmakers. Yet some companies say the impact will be modest. 
      • “Some of the muted effect is because drugmakers already provide rebates and discounts to Medicare drug-benefit plans on many drugs. So, the negotiated prices aren’t as much of a discount off net prices as they are from list prices.”
    • Here’s a link to the CMS news release about the 2027 Medicare drug price negotiations.
    • Bloomberg adds,
      • “The Trump administration on Tuesday proposed a rule cementing changes to patient cost-sharing in Medicare’s Part D prescription drug benefit and updating the methodology used to rate private Medicare Advantage plans.
      • “If finalized, the rule, RIN 0938-AV63, would implement changes to Part D that Congress enacted as part of the Inflation Reduction Act under President Joe Biden, and update the methodology used to award insurers quality “star ratings” that determine bonuses and marketing privileges. The changes would take effect in 2027.” * * *
      • “The CMS also proposed eliminating star ratings measures that it said were based on “administrative processes” and not indicative of a plan’s quality. The agency is also proposing to forgo a change related to enrollees with social risk factors, and to add new measures focused on treating depression.
      • “The proposal would also allow Medicare Advantage members a special enrollment period when their doctor leaves their network.”
    • Here’s a link to the CMS fact sheet on this proposed rule.
    • Healthcare Dive offers a good summary of the Medicare changes found in the outpatient facility pricing final rule released last Friday. For example,
      • “Hospital outpatient departments currently receive higher reimbursement for providing the same services compared with freestanding physician offices and ambulatory surgery centers — a policy critics say drives up costs for patients and Medicare. 
      • “In the latest payment rule, the CMS finalized a regulation that would reimburse off-campus outpatient departments owned by hospitals at the same rates as physician offices for drug administration services. 
      • “That change should cut outpatient spending by $290 million in 2026, with $220 million of the savings going to Medicare and $70 accruing to beneficiaries, according to the CMS. 
      • “Additionally, the agency is moving to phase out the inpatient only list, a list of which surgical procedures have to be furnished in hospitals, over three years. The CMS will start with removing 285 mostly musculoskeletal procedures next year.
      • “The American Hospital Association lambasted the site-neutral policy changes, arguing they ignore the differences between care delivery at hospital outpatient departments and other care sites.” 
    • The Wall Street Journal reports,
      • “The Centers for Disease Control and Prevention appointed Louisiana surgeon general Dr. Ralph Abraham as the second in command, the latest move in a year of upheaval for the agency.
      • “Abraham, a vaccine skeptic, has been named the deputy principal director of the CDC. The agency has shuffled through multiple leaders since Health Secretary Robert F. Kennedy Jr., also a vaccine skeptic, began overseeing the CDC earlier this year.
      • “Kennedy’s views on vaccines have caused turmoil at the agency. Susan Monarez, the former CDC director, said she was ousted after refusing to approve all future recommendations from a vaccine advisory panel filled with Kennedy’s appointees and refusing to fire CDC vaccine-policy officials. Jim O’Neill, Kennedy’s deputy, is currently serving as the CDC’s acting director.
      • ‘Most recently, a CDC webpage that previously said vaccines don’t cause autism now says they might—an assertion former CDC employees and doctors outside the agency have fervently disagreed with.
      • “Abraham was appointed the Louisiana surgeon general last year and later criticized government vaccine mandates. He condemned Covid-19 vaccine mandates earlier this year as “an offense against personal autonomy that will take years to overcome.” * * *
      • “The family-medicine doctor and veterinarian also represented Louisiana in Congress from 2015 to 2021.”
    • Tammy Flanagan, writing in Govexec, opens her Mailbag: Retirement applications and processing/ A look at common retirement-processing snags, what causes delays and where OPM’s newer systems fit into the picture.”

    From the Food and Drug Administration front,

    • The American Hospital Association News informs us,
      • “The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil Speed Control Dials used with the SmartDrive MX2+ Power Assist Device for wheelchairs after identifying a design issue that can lead to unexpected behavior of the SmartDrive motor. The FDA said Max Mobility/Permobil reported two serious injuries associated with the issue.
      • “In addition, the FDA issued an early alert for certain Fresenius Kabi Ivenix LVP Primary Administration Sets due to an assembly defect.”
    • Per Fierce Pharma,
      • “AstraZeneca’s Imfinzi is adding yet another landmark perioperative label to its belt with a new FDA approval that gives the drug the title of the first and only immunotherapy marketed to treat early-stage stomach cancer patients both before and after surgery.
      • “With the nod, Imfinzi can be added to standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) to treat adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. The approval specifically allows Imfinzi to be used with chemotherapy before surgery, then after surgery with chemotherapy and eventually on its own as a monotherapy.”
    • and
      • “When the FDA reworked the prescribing information for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy Elevidys earlier this month, the company touted a plan to study a regimen designed to reduce liver-associated risks and potentially reach patients left off of the drug’s new label. Now, with the FDA’s go-ahead, the company is commencing with that effort.
      • “The FDA gave Sarepta the green light to use an “enhanced immunosuppressive regimen” in the planned Cohort 8 of its Endeavor study, the company announced in a Tuesday press release. The regimen, which features the administration of sirolimus prior to and after the Elevidys infusion, will be studied in non-ambulatory individuals with DMD or those who can no longer walk independently.”
    • MedTech Dive relates,
      • “Ceribell has received 510(k) clearance to use its Clarity seizure-detection algorithm in neonates, the company said Monday.
      • “The algorithm processes data captured by a headcap with electroencephalography sensors to detect electrographic seizures. Subclinical seizures can go undetected without EEG monitoring.
      • “Ceribell executives have estimated that the neonatal and pediatric markets will add $400 million to its current $2 billion addressable market opportunity.” 
    • STAT News points out,
      • “The Food and Drug Administration on Tuesday approved the first drug from an emerging class of medicines for patients with chronic, autoimmune kidney disease, according to a notice on the agency’s website.
      • “The new drug, called Voyxact, is made by Otsuka, the Japanese pharmaceutical company. U.S. regulators cleared it to treat IgA nephropathy, or IgAN, a disease caused by the build-up of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.”

    From the judicial front,

    • Healthcare Dive reports,
      • “The Trump administration will continue to fight in court over a Biden-era regulation that would audit Medicare Advantage plans and claw back billions of dollars in overpayments.
      • “In a Friday filing, the federal government said it would appeal a judge’s decision from September that vacated the Medicare Risk Adjustment Data Validation, or RADV, rule for violating the Administrative Procedures Act.
      • “The move to take the case to the Fifth Circuit Court of Appeals comes as regulators have said they’ll crack down on MA overpayments, including through a plan this spring to increase audits.”
    • Per Fierce Healthcare,
      • “Humana will appeal a court loss over the Medicare Advantage star ratings, according to a filing issued Tuesday.
      • “The insurer filed a notice that it will appeal the District Court ruling to the Fifth Circuit Court of Appeals. The filing doesn’t offer further details on the grounds to appeal.
      • “Humana first filed suit to challenge the star ratings methodology in October 2024 after the number of people enrolled in plans with four or more stars dropped from 94% in 2024 to 25% in 2025. In the most recent round of scores, the number of enrollees in plans with at least four stars decreased further to 20% for 2026.
      • “In the lawsuit, Humana argues that the Centers for Medicare & Medicaid Services determined that three test phone calls were poor, which drove the score drop.
      • “Texas Judge Reed O’Connor tossed the case in mid-October, saying that these determinations were not “arbitrary and capricious” and instead complied with federal law.”

    From the public health and medical / Rx research front,

    • The Wall Street Journal reports,
      • “A new study found people with untreated obstructive sleep apnea could have an increased risk of developing Parkinson’s disease.
      • “Researchers studied medical records for more than 11 million military veterans between 1999 and 2022 and found those with obstructive sleep apnea had a higher chance of developing Parkinson’s disease compared with those without the disorder, according to the study published in JAMA Neurology on Monday. 
      • “It’s not at all a guarantee that you’re going to get Parkinson’s, but it significantly increases the chances,” said Dr. Gregory Scott, a co-author of the study and assistant professor at the Oregon Health & Science University School of Medicine, or OHSU.”
    • A commentator in STAT News tells us,
      • “For years, federal policymakers have tweaked lung cancer screening guidelines as if the barrier to saving lives is a math problem. Add a few years to the eligibility age. Drop a few pack-years — a measure combining how much and how long someone has smoked. Remove a quit-time rule. Repeat.
      • “But it was never really a math problem. A new study in JAMA Network Open makes clear what many of us in cancer prevention and control have been warning for over a decade: No amount of technical adjusting will fix a system built on stigma.
      • “I see the effects of this every day. As a behavioral scientist and nurse practitioner, I’ve sat with hundreds of patients confronting the potential of a lung cancer diagnosis. I’ve watched people brace themselves before they say the words “I used to smoke,” even when they quit decades ago. I have watched people who have never smoked rush to explain why they got lung cancer at all.
      • “These reactions aren’t personal quirks. They are predictable responses to a system that has taught people to expect judgment.”
      • “That system is failing on its own terms. The new study examined nearly 1,000 people diagnosed with lung cancer at a major academic medical center and found that 65% would not have qualified for screening under today’s U.S. Preventive Services Task Force (USPSTF) criteria.” * * *
      • “The population ineligible for screening is not random. It is disproportionately women, Asian Americans, and people who have never smoked. These are groups the current framework structurally misclassifies as “lower risk,” despite real-world evidence to the contrary.
      • “Only one approach captures nearly all of them: age-based screening. The test itself is straightforward: a low-dose CT scan that takes about 10 minutes and exposes patients to minimal radiation. Screen everyone ages 40 to 85, regardless of smoking history, and you detect 94% of cancers and prevent more than 26,000 deaths every year.  The cost is lower than what we routinely pay for breast or colorectal cancer screening. The number needed to screen to prevent one lung cancer death is 320. For comparison, mammography requires screening about 1,339 women to prevent one breast cancer death, and colonoscopy requires screening about 455 people to prevent one colorectal cancer death. Yes, broader screening means more false positives and follow-up imaging, but these trade-offs are manageable — and far less burdensome than the status quo, which misses two-thirds of cases entirely.”MedP
    • MedPage Today lets us know,
      • “Guidelines recommend a single dose of RSV vaccine for older adults, but long-term data on the duration of protection is limited.
      • “In this study of U.S. veterans, effectiveness slid from over 80% in the month following vaccination to about 60% through 18 months. Among the immunocompromised individuals, vaccine effectiveness fell from 75% to 40%.
      • “The potential benefits and risks of a second vaccine dose in certain groups should be examined,” according to the authors.”
    • The New York Times reports,
      • “Danish researchers were examining the use of medications during and after pregnancy when they noticed a clear trend: The number of women using weight-loss drugs like Ozempic and Wegovy soon after childbirth had risen sharply.
      • ‘In 2018, few women were using the drugs during the first six months after having a baby, with fewer than five prescriptions for every 10,000 new mothers. By mid-2022, that figure had increased to 34 prescriptions for every 10,000 new mothers, and by mid-2024, it had jumped to 173 prescriptions for every 10,000, or almost 2 percent of postpartum mothers. Most of the women were over 30, and two-thirds had more than one child. A majority were overweight, but they did not have diabetes, and they had no history of using the drugs, known as GLP-1s, the researchers wrote.
      • “In a period characterized by natural weight loss and marked hormonal change, this was unexpected,” said Mette Bliddal, a pharmacologist and researcher at University of Southern Denmark in Odense, Denmark, and the paper’s first author.
      • “The new study was published online on Monday in JAMA Network Open.” * * *
      • “Although semaglutide, the active ingredient in Wegovy and Ozempic, aids in weight loss, little is known about the drug’s effects after childbirth, when new mothers are experiencing hormonal changes.
      • “The American College of Obstetricians and Gynecologists has not issued a guidance about the use of weight-loss drugs postpartum because the drugs are so new and the data is insufficient. But First Exposure, a digital information hub and research network at the University of Toronto that provides evidence-based information about drug safety during pregnancy, recommends that patients avoid taking the drugs while breastfeeding. (First Exposure also recommends not taking the medications during pregnancy and stopping them a month or two before a planned pregnancy).”

    From the U.S. healthcare business and artificial intelligence front,

    • The American Hospital Association News notes,
      • “The Trump administration issued an executive order Nov. 24 launching the Genesis Mission, an artificial intelligence initiative focusing on scientific research. The program will focus on efforts related to national, economic and health security, among other areas. The order adds to other White House actions in recent months regarding AI innovation and infrastructure to support health care and other sectors.”
    • Bloomberg points out,
      • “Thousands of health providers that treat lower-income and uninsured patients are scrambling to adjust to a new program to access steeply discounted medicines from drugmakers that stands to overhaul their operations and finances.
      • “The 340B Rebate Model Pilot Program, administered by the US Health Resources & Services Administration, is set to significantly change how the 340B Drug Pricing Program operates after the Trump administration approved rebate models from pharmaceutical companies such as Bristol Myers Squibb Co., Johnson & Johnson, and Novo Nordisk A/S.
      • “Drugmakers under the federal program currently provide up-front drug discounts to covered safety-net hospitals, clinics, and health centers that treat a disproportionate number of low-income and uninsured patients. But under the pilot, covered providers, starting on Jan. 1, 2026, will buy certain medicines at full price and then submit data to drugmakers to receive a rebate.
      • “Health providers are now preparing for the pilot—grappling with nine unique drugmaker models, weighing operational changes, and analyzing the financial risks with purchasing drugs at commercial prices.”
    • Per Beckers Payer Issues,
      • “UnitedHealth Group has purchased a four-story, 79,000 square foot medical office building in Henderson, Nevada.
      • “The $46.1 million building houses Optum Nevada’s new Cactus Healthcare Center and marks the largest medical office transaction in the Las Vegas market this year, according to real estate firm Colliers.
      • “UnitedHealth purchased the building through its Sierra Health and Life Insurance subsidiary in October, the Las Vegas Review-Journal reported.”
    • Fierce Healthcare informs us,
      • “Capital Rx has unveiled Capital Equilibrium, a new level-funding pharmacy benefit management offering.
      • “The program leans on an A-rated stop-loss carrier for reinsurance as well as Capital Rx’s PBM services to provide a fixed monthly payment plan that covers anticipated claims, administrative costs and stop-loss. The pricing is often below market rates, according to the announcement.
      • “The stop-loss insurance manages claims that exceed monthly limits, while the PBM piece is built on a “fair” pricing structure that eschews traditional discounts and rebates, Capital Rx said.
      • ‘Plan sponsors in all 50 states can sign on with Capital Equilibrium, according to the announcement.”
    • Genetic Engineering and Biotechnology News identifies the “Top 20 Drugs Heading for the Patent Cliff, 2026-2029. Last year, these treatments accounted for 75% of the $236B in annual sales set to vanish with the loss of exclusivity.”
    • McKinsey & Co. delves into the five dimensions of the wellness economy.
    • Per BioPharma Dive,
      • “Gilead Sciences is looking at a new way to attack cancer, buying into a preclinical program from the Swedish biotech Sprint Bioscience.
      • “The deal announced Monday centers on a target known as TREX1. Research suggests a healthy TREX1 gene can help prevent overactivation of the immune system that leads to conditions such as lupus, but it may also help cancer cells hide from the body’s natural attackers. In oncology, researchers are trying to inhibit TREX1 to unleash anti-tumor immune activity.
      • “TREX1 has demonstrated significant potential in the preclinical phase,” Sprint Bioscience CEO Johan Emilsson said in a statement. The new agreement calls for Gilead to pay Sprint $14 million up front and as much as $400 million more if the program meets certain clinical, regulatory and commercial milestones.”

    Friday report

    David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, SDOH, U.S. Healthcare–

    From Washington, DC,

    • Roll Call reports,
      • “A bipartisan group of House lawmakers released text of legislation Friday aimed at avoiding the health care subsidy cliff by extending Affordable Care Act tax credits for two years while installing income caps and anti-fraud measures.
      • “Reps. Tom Suozzi, D-N.Y., Don Bacon, R-Neb., Josh Gottheimer, D-N.J., and Jeff Hurd, R-Colo., see the measure as a viable compromise that includes Democrats’ demand for a subsidy extension alongside protections sought by many Republicans. It would also significantly lengthen the open enrollment window, which would allow more people into plans, thus strengthening risk pools and lowering premiums.
      • “The text arrives as much of Congress is divided on how to approach the possible end to enhanced premium tax credits under the 2010 health care law, which expire Dec. 31. Many Republicans see any extension as propping up the ACA and won’t support such a move. Without a solution, prices for insurance through state exchanges or healthcare.gov could force people to quit the coverage.” * * *
      • “A bill from Reps. Sam Liccardo, D-Calif., and Kevin Kiley, R-Calif., that also features a two-year extension largely follows a similar framework.
      • “Unlike the Liccardo-Kiley bill, however, this legislation does not include language that would limit excessive payments to Medicare Advantage, a practice known as upcoding. The Liccardo-Kiley bill incorporated the Medicare Advantage language as an offset to pay for the tax credit extension.”
    • and
      • “At least one of the Senate’s yet-to-be-unveiled fiscal 2026 appropriations bills could be released next week, even though lawmakers will be in their districts for the Thanksgiving recess.
      • “There is a good chance the Senate will post its version of the Energy-Water bill, one of the four the Senate has not yet released, House Appropriations Chair Tom Cole, R-Okla., said Friday.
      • “The issue was discussed when the top four House and Senate appropriators met Thursday, Cole said. “I don’t know about the other three, but we raised a lot of questions about Energy and Water, since we’ve actually passed that one across the [House] floor,” he said.
      • “Senate appropriators are aiming to release that bill and potentially more of the outstanding bills — Financial Services, Homeland Security and State-Foreign Operations — next week, a source familiar with the plan said. But that plan is not final, the source said.
      • “House Appropriations ranking member Rosa DeLauro, D-Conn., said Friday that the lawmakers discussed the outstanding Senate bills and that Senate Appropriations Chair Susan Collins, R-Maine, said the text could be posted early next week.”
    • Mercer consulting offers an overview of the current healthcare care policy debate in Congress.
    • OPM Director Scott Kupor posted a new Secrets of OPM blog entry, this time about ongoing Administration efforts to right size the federal workforce.
    • Per an HHS news release,
      • “The Centers for Medicare & Medicaid Services (CMS) is improving the quality of care for Medicare beneficiaries while significantly reducing unnecessary spending and improving choices and hospital price transparency for Medicare beneficiaries. The calendar year (CY) 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule (CMS-1834-FC) advances a series of patient-focused reforms that will modernize payments, expand access to care, enhance hospital accountability, and safeguard the Medicare Trust Funds from fraud, waste, and abuse.
      • “This final rule from CMS closes the loopholes hospitals exploit to hide real prices and advances President Trump’s demand for radical hospital price transparency,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are also confronting addiction head-on by expanding access to non-opioid treatments and implementing common-sense payment policies that make care more affordable and accessible for seniors.”
      • “We are strengthening Medicare’s foundation by protecting beneficiaries, eliminating fraud, and advancing medical innovation —all while maintaining strict provider accountability and responsible use of taxpayer funds,” said CMS Administrator Dr. Mehmet Oz. “These comprehensive reforms expand patient choice and establish the price transparency Americans need for confident healthcare decisions.” * * *
      • “The final rule can be viewed at the Federal Register at: www.federalregister.gov/public-inspection/.
      • “View the fact sheet on the final rule at: www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-ambulatory-surgical-center.
      • “For a fact sheet on the hospital price transparency policy changes in the final rule, visit: www.cms.gov/newsroom/fact-sheets/cy-2026-opps-ambulatory-surgical-center-final-rule-hospital-price-transparency-policy-changes.”
    • The American Hospital Association adds,
      • “The Centers for Medicare & Medicaid Services released an updated notice Nov. 20 on the processing of Medicare provider claims impacted by the government shutdown. The agency said it instructed Medicare Administrative Contractors to conduct mass adjustments to any paid claims that are inconsistent with the government funding legislation, which retroactively restored many payment provisions through Jan. 30. This includes a payment adjustment for low-volume inpatient hospitals and one for the Medicare-dependent Hospital program. In addition, CMS said that hospitals can resubmit returned claims for telehealth services and the Acute Hospital Care at Home program dated Oct. 1 or later.”

    From the Food and Drug Administration front,

    • Cardiovascular Business reports,
      • “Hexoskin, a Canadian medtech company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new “smart shirt” capable of long-term heart and respiratory monitoring. 
      • “The Hexoskin Medical System was designed to deliver continuous evaluations of a person’s real-time electrocardiogram (ECG) and respiratory health. Signals are then evaluated through the company’s data management platform.
      • “According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as medical researchers. The device is now approved for use during clinical trials performed in the United States, for example, delivering ECG, heart rate, respiratory rate and other activity data that can research teams can track for extended periods of time.
      • “Hexoskin has also made it a priority to use advanced artificial intelligence algorithms to seek out new digital biomarkers that work “beyond traditional cardiopulmonary monitoring.” 
    • Fierce Pharma adds,
      • “As the researchers behind Pfizer and Astellas’ Padcev and Merck’s Keytruda have taken victory laps on the heels of the positive readout of Keynote-905 study—also known as EV-303—terms like “transformational,” “practice-changing” and “new standard of care” have been put to use.
      • “With an FDA approval on Friday, the combination now has its official go-ahead as a perioperative treatment regimen for people with muscle-invasive bladder cancer (MIBC) who can’t receive chemotherapy.
      • ‘Padcev and Keytruda is the first and only approved perioperative treatment regimen for cisplatin-ineligible patients with MIBC, Pfizer said in a media statement Friday, meaning the pairing can be used before and after surgery.
    • and
      • “The FDA has opened an investigation into Takeda’s recombinant protein med Adzynma following the reported death of a pediatric patient who received the drug.
      • “The probe comes as the regulator says it has received multiple postmarketing reports of patients developing neutralizing antibodies to ADAMTS13, the enzyme-creating gene that underpins Takeda’s drug. The single reported patient death “appears to be related to Adzynma,” the FDA said in a Nov. 21 safety communication.
      • “Takeda’s medicine was approved in November of 2023 as the first recombinant protein product for use as a preventive or on-demand enzyme replacement therapy in adults and children with the rare genetic blood-clotting disorder, congenital thrombotic thrombocytopenic purpura (cTTP). The condition is believed to be caused by a disease-triggering mutation in the ADAMTS13 gene, which produces an enzyme responsible for regulating clotting.
      • “The Tokyo-based pharma did not respond to Fierce Pharma’s request for comment on the situation by publishing time.”

    From the public health and medical / Rx research front,

    • The Centers for Disease Control and Prevention announced Friday,
      • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits increasing among children 0-4 years old. Seasonal influenza activity remains low nationally but is increasing. COVID-19 activity is low nationally.
      • “COVID-19
        • “COVID-19 activity is low nationally.
      • “Influenza
      • “RSV
        • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits increasing among children 0-4 years old.
      • “Vaccination
        • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.’ * * *
      • “Season Outlook
        • “CDC expects the upcoming fall and winter respiratory disease season in the United States will likely have a similar number of combined peak hospitalizations due to COVID-19, influenza, and RSV compared to last season. CDC will update this outlook every two months throughout the season and as warranted by changes in the trajectories of any of the three diseases. Read more: 2025-2026 Respiratory Disease Season Outlook“
    • Beckers Clinical Leadership adds,
      • “Some hospitals are reporting an uptick in respiratory syncytial virus hospitalizations in recent days, though national data — delayed by the federal shutdown — has yet to offer a clear picture.
      • “Cincinnati Children’s Hospital reported an early uptick in admissions this fall, according to Hamilton County Public Health Medical Director Steve Feagins, MD.
      • “Last year, we saw it early. This year, we saw it even earlier, resulting in, like, September beginning to get some admissions and hospitalizations at Cincinnati Children’s,” he told CBS affiliate WKRC.
      • “The county reported 32 admissions in the week ending Nov. 15, up from 28 a week prior, state data shows.” 
    • The University of Minnesota CIDRAP relates,
      • “Over 40% of nearly 8,600 US adults who had advanced hepatitis B–related liver disease appear to have received no treatment for their infection, a gap especially apparent in women and Black or White patients, according to findings published yesterday in JAMA Network Open.
      • “A team led by a Stanford University researcher and including scientists from hepatitis B virus (HBV) drug maker and study funder Gilead Sciences evaluated the HBV treatment status of 8,594 infected patients included in an electronic health record data network from April 2016 to December 2022. The study focused on patients who met American Association for the Study of Liver Diseases 2016 and 2018 qualification criteria for HBV treatment.
      • “Treatment of hepatitis B virus (HBV) infection reduces the risk of disease progression and negative outcomes such as hepatic decompensation and hepatocellular carcinoma (HCC),” the researchers wrote. “Studies from select populations in the US suggest that treatment levels are low; whether this pattern occurs nationally remains unclear.” * * *
      • In a commentary in the same journal, Amir Mohareb, MD, of Massachusetts General Hospital, and Arthur Kim, MD, of Harvard Medical School, noted that the risk of perinatal HBV transmission from mother to child is very low in the United States due to the availability of HBV immunoglobulin and the HBV vaccine birth dose. 
      • “But “there is cause for concern that this policy may change, as newly appointed members of the Advisory Committee on Immunization Practices in 2025 debate removing the recommendation for birth-dose HBV vaccination in the US,” they wrote.
      • “Removing the recommendation for universal birth-dose vaccination would be a major step backward for elimination of HBV and would be potentially in direct contradiction to the Department of Health and Human Services Viral Hepatitis National Strategic Plan for the US,” they added”
    • Beckers Hospital Review tells us,
      • “The overall U.S. healthcare system received a “C” grade from a broad survey of U.S. adults, according to the West Health-Gallup Center for Healthcare in America, which released its inaugural report, “State of the States 2025: Insights on Healthcare in America.”
      • “Nationwide, the healthcare system received a “D+” for cost, a “C+” for quality and a “C+” for access. 
      • “The rankings are based on an online survey of 19,535 U.S. adults conducted June 9 to Aug. 25 across all 50 states and the District of Columbia. Respondents graded the healthcare system in their state, with letter grades converted to a 4.0 GPA scale for analysis.”
    • A medical specialist interviewed in MedPage Today identifies “13 Visible Signs of Heart Disease. What skin, nails, eyes, and more can reveal about cardiovascular disease.”
    • Health Day informs us,
      • “Even occasional or low-intensity smoking significantly increases cardiovascular and mortality risks, according to a study published online Nov. 18 in PLOS Medicine.
      • “Erfan Tasdighi, M.D., from the Johns Hopkins Ciccarone Center for Prevention of Cardiovascular Disease in Baltimore, and colleagues examined the relationships among smoking burden, intensity, and cessation duration across multiple cardiovascular outcomes. The analysis included data from 323,826 adult participants in 22 prospective cohort studies with median follow-up varying from 14.4 to 19.9 years.” * * *
      • “It is remarkable how harmful smoking is — even low doses of smoking confer large cardiovascular risks,” the authors said in a statement. “As far as behavior change, it is imperative to quit smoking as early in life as possible, as the [amount] of time passed since complete cessation from cigarettes is more important [than] prolonged exposure to a lower quantity of cigarettes each day.”
      • “Abstract/Full Text“
    • and
      • “The risk for motor vehicle crashes is increased after a concussion, according to a study published online Nov. 5 in BMJ Open.” * * *
      • “The risk of a motor vehicle crash after a concussion suggests current mitigating efforts are insufficient; however, driving cessation may be unreasonable since the risk also extends to patients as pedestrians,” the authors write. “Instead, clinicians might warn concussion patients to be cautious about prevailing motor vehicle crash risks along with standard anticoncussion campaigns.”
      • “Abstract/Full Text“
    • Healio points out,
      • “Child abuse is linked to long-term risk for negative health outcomes. 
      • “Boys and girls experienced decreases in confirmed maltreatment cases, but girls were subject to greater maltreatment.” * * *
      • “As a preventive measure, we need to address the drivers of maltreatment,” Richard T. Liu, PhD, director of suicide research in the division of child and adolescent psychiatry in the Depression Clinical and Research Program at Massachusetts General Hospital, told Healio. “One prominent driver of maltreatment risk is poverty. Reducing poverty would therefore be important for reducing risk for child maltreatment.”

    From the U.S. healthcare business front,

    • This factoid along with more importantly this Brookings Institute report on PBM profitability support the FEHBlog’s view that cracking down on PBMs will not lower healthcare costs. The President’s efforts to lower drug costs could pay dividends.
    • Modern Healthcare adds,
      • “Eli Lilly & Co. and Novo Nordisk A/S plan to start selling their popular obesity shots to employers through a new approach that would bypass traditional drug sales channels in an effort to expand access to the costly weight-loss medicines.
      • “The drugmakers will offer Zepbound and Wegovy to companies starting Jan. 1 through Waltz Health, a firm that helps employers purchase cheaper medications. The shots will be available to employers at upfront, fixed prices, avoiding the rebates and fees that accompany traditional sales through middlemen who manage pharmacy benefits for many companies.” * * *
      • “The offering is aimed at employers that don’t cover obesity drugs right now. About 43% of companies with more than 5,000 workers cover weight-loss drugs, according to a recent survey from KFF. Thierer said four employer clients are signed up to launch the offering in January. Waltz is targeting a goal of making it available to 100,000 people by the end of the first quarter.
      • “The arrangements will only apply to the companies’ weight-loss drugs, not to similar medications intended for diabetes. Waltz will handle screening patients to see if they’re eligible for the drugs, sending prescriptions to pharmacies and supporting patients taking the drugs.
      • “Waltz was recently purchased by a larger firm, Eversana, that works with drug companies to commercialize and distribute their medications. Thierer, a former PBM executive, has said he aims to build an alternative to the “oligopoly” of PBMs and force the industry to change.”
    • Per Yahoo Finance,
      • “CVS Health® (NYSE: CVS) today announced that its Board of Directors has elected President and Chief Executive Officer David Joyner as Chair of the Board, effective January 1, 2026. Following the effective date of this appointment, Michael Mahoney will continue to serve as the Board’s Lead Independent Director, and Roger Farah, who is currently serving as Executive Chair of the Board, will continue to serve on the Board.
      • “Joyner was named President and CEO of CVS Health in October 2024, and has led significant operational, financial and cultural improvements in the Company’s performance over the past year. In recognition of his leadership, nearly 40 years of experience in the health care industry, and the Company’s future growth opportunities, the Board determined Joyner should also serve as Chair of the Board.”
    • Healthcare Dive lets us know,
      • “Western Pennsylvania-based Independence Health System plans to join West Virginia University Health System in the fall of next year, the systems announced Wednesday.
      • ‘Under the proposed merger, which is subject to regulatory reviews and approvals, Independence Health’s five hospitals as well as its affiliated physician groups will operate under WVU Medicine’s brand. 
      • “The systems say the deal will offer operational and financial efficiencies through resource sharing and allow the providers to expand clinical services and access to specialty care.”
    • Per MedTech Dive
      • “Solventum said Thursday it has struck a deal to buy wound care company Acera Surgical for $725 million in cash.
      • “The deal, which features up to $125 million in milestones, will give Solventum control of a portfolio of synthetic soft tissue repair products. Stifel analysts said in a note to investors that they believe the synthetic market “is growing at a double-digit pace.”
      • “Acera is Solventum’s first acquisition since it spun out of 3M. Solventum executives made M&A part of their focus after selling the company’s purification and filtration business to Thermo Fisher Scientific for $4.1 billion.”

    From the artificial intelligence front,

    • Cardiovascular Business reports,
      • “Heartflow’s Plaque Analysis software is an effective tool for the diagnosis and management of coronary artery disease (CAD), according to a new retrospective analysis of more than three years of data. The findings were presented at the American Heart Association’s Scientific Sessions 2025 conference.
      • “The FDA-cleared Plaque Analysis software was designed to evaluate coronary CT angiography (CCTA) results and provide cardiologists with an artificial intelligence (AI)-powered assessment of the patient’s coronary plaques. It delivers an interactive 3D model of the coronaries and identifies high-risk CAD patients who may benefit from immediate care. 
      • “This latest analysis included nearly 8,000 symptomatic CAD patients who participated in the FISH&CHIP study. All patients were treated with Plaque Analysis as well as Heartflow’s new Plaque Staging framework. Plaque Staging separates patients into one of four categories—mild, moderate, severe or extensive—based on AI-powered total plaque volume (TPV) measurements. According to Heartflow, this study represents the largest validation to date of the Plaque Staging framework.”
    • McKinsey & Co. explores “the coming evolution of healthcare AI toward a modular architecture.”
    • The Advanced Research Projects Agency for Health (ARPA-H) announced
      • “The AIR program [which’ aims to solve these problems by developing robots that can do parts of or entire surgical interventions on their own. The program’s focus is twofold: first, to develop autonomous robotic systems that can perform thrombectomies, making curative stroke care available to all Americans. Second, to create very small, mechanical, electronic, or hybrid devices (microbots) that can perform medical procedures independently, revolutionizing healthcare delivery.
      • “Notice ID: ARPA-H-SOL-26-146
        • ARPA-H invites interested parties to review the solicitation, which is posted and maintained on SAM.gov. The solicitation outlines the opportunity and its requirements, key dates and deadlines, submission documents and templates, evaluation criteria for submissions, and information on how to apply.
      • “Key Dates:
        • Proposers’ Day: December 16, 2025, Bethesda, MD (Hybrid)
        • Solution Summaries due: January 26, 2026
        • Proposals due: March 30, 2026
      • “Reminder: Dates are estimates and are subject to change. Please reference the solicitation for the most up-to-date information.”