FEHBlog

Monday report

David Ermer–ACA, Congress, FDA, Medical / Rx research, NIH, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Per a Senate news release,
    • “U.S. Senators Mike Crapo (R-Idaho), chair of the Senate Finance Committee, and Bill Cassidy, M.D. (R-Louisiana), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, unveiled the Health Care Freedom for Patients Act, historic Republican legislation to lower health care costs and give money directly to families to control their own care. This bill is an alternative to Democrats’ temporary COVID bonuses, which send billions of tax dollars to giant insurance companies without lowering insurance premiums.
    • “Giving billions of taxpayer dollars to insurers is not working to reduce health insurance premiums for patients,” said Senator Crapo. “We need to give Americans more control over their own health care decisions. This bill builds on the work we did in the Working Families Tax Cuts Act and will help Americans manage the rising cost of health care without driving costs even higher.”
    • “Instead of 100 percent of this money going to insurance companies, let’s give it to patients. By giving them an account that they control, we give them the power. We make health care affordable again,” said Dr. Cassidy.
    • “This legislation:
      • “Sends money to patients, not giant insurance companies;
        • “Americans on affordable bronze and catastrophic plans would access these dollars in a Health Savings Account (HSA).
        • “These funds cannot be used for abortion or dangerous gender transitions.
      • “Lowers insurance premiums by funding cost-sharing reduction (CSR) payments [beginning in 2027};
      • “Empowers Americans to choose the insurance plan that fits their needs by increasing access to low-cost catastrophic plans;
      • “Prevents illegal immigrants from accessing Medicaid by requiring states to verify citizenship and immigration status before coverage; and
      • “Stops taxpayer dollars from funding gender transition services under Medicaid and excludes them as an essential health benefit for plans sold on the Obamacare exchanges.” * * *
    • Click here for a one-pager.
    • Click here for bill text.
  • MedPage Today reports,
    • “Members of the Medicare Payment Advisory Commission (MedPAC) generally responded favorably Thursday to a draft recommendation to increase reimbursement in 2027 for physicians who treat Medicare patients — with one exception.
    • “The MedPAC chairman’s draft recommendation was to “increase payment rates for physician and other health professional services by 0.5 percentage points more than current law.” However, commission member Brian Miller, MD, MPH, of Johns Hopkins University in Baltimore, pointed out that last year, “[MedPAC’s recommended] physician fee schedule update … was a net update of 3%.”
  • Govexec tells us,
    • “The Trump administration laid out its plans to “end weaponized government” in its new management agenda released Monday. 
    • “The latest President’s Management Agenda includes goals to eliminate “woke” programs, downsize the government workforce and real estate portfolio, implement workforce reforms and modernize government technology, as well as targets to “annihilate government censorship of speech” and centralize government contracting.
    • “The agenda reflects much of the Trump administration’s longstanding priority to drastically reshape the government, an objective the White House focused on immediately after the inauguration through its Department of Government Efficiency.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  [The manufacturer is Gamida Cell Ltd.]
    • “This approval is revolutionary in the therapeutic landscape and fundamentally changes how we approach treatment for SAA, where earlier treatment has potential to alter one’s life course,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “Severe aplastic anemia is a rare blood disorder that can be fatal, and the FDA remains committed to expanding treatment options for patients with this disease.”  
  • CNN adds,
    • “Medical technology company MED-EL announced Thursday [December 4] that the US Food and Drug Administration has approved expanding the use of its Synchrony cochlear implants to children as young as 7 months who have bilateral profound sensorineural hearing loss. The implants were previously indicated for 9 months and older.”

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court seemed poised Monday to expand the president’s power to fire the heads of many regulatory agencies, even as one pivotal justice expressed a desire to insulate the Federal Reserve from political pressure.
    • “During 2½ hours of oral arguments, the justices probed the limits of President Trump’s assertion of virtually unfettered authority to remove agency leaders, despite federal laws that protect them from being fired over policy disagreements.
    • “Justice Brett Kavanaugh pointedly asked Solicitor General D. John Sauer about concerns from economists that a broad victory for Trump in the case would jeopardize the independence of the Fed’s board of governors.
    • “I share those concerns,” said Kavanaugh, a Trump appointee.
    • “Still, Kavanaugh and the other five conservative justices were, as expected, mostly receptive to the administration’s argument that the president is entitled to more control over dozens of regulatory bodies in the executive branch, such as the Federal Trade Commission and the National Labor Relations Board.”
  • The Supreme Court is expected to announce its decision toward the end of the current term in June 2026.

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Brayan Garcia was driving along a highway in his red Toyota Corolla when he slammed into the back of a Ram pickup truck that was stopping at an intersection in West Texas.
    • “Garcia, 22, died at the scene of the early morning crash. His Corolla sustained heavy damage, its hood ripped off entirely. Debris was scattered across several lanes. But despite hitting the truck directly, the Corolla’s air bags never went off.
    • “Toyota had recalled Garcia’s car in 2020 over a dangerous defect that could stop its air bags from deploying. But Garcia’s vehicle hadn’t gotten the fix, like millions of others currently on the road. 
    • “From 2015 to 2024, about 12 million vehicles were recalled for safety defects that could result in air bags not deploying. These recalls—37 in total—included models made by General Motors and Ford as well as luxury brands such as Mercedes-Benz and Audi. 
    • “About 2.6 million, or around 22%, of affected vehicles remain unfixed, according to an analysis of the latest National Highway Traffic Safety Administration data by The Wall Street Journal.
    • “The Journal found 12 people, including Garcia, who died after crashes in Toyotas and other vehicles where the air bag was under recall, hadn’t been repaired and didn’t deploy. 
    • “The NHTSA data reveal a broader problem: Roughly one in three cars recalled for all reasons goes unfixed. The rate is roughly the same even for serious flaws such as failing brakes, engine fires or the air bag defects reviewed by the Journal.”
  • The New York Times relates,
    • “The statistics are incontrovertible: Since 1992, the diagnoses of eight cancers has doubled in the United States in patients under age 50, including cancers in the thyroid, anus, kidney, small intestine, colorectum, endometrium and pancreas, as well as the blood cancer myeloma. Other types, including breast cancer, also are on the rise.
    • “The magnitude and speed at which early onset cancer incidence has increased is unlike most cancer trends ever observed (the possible exception being cigarette smoking and lung cancer),” the American Association for Cancer Research said in its announcement of a special conference being held this week that will explore the rise in cancers among younger people.
    • “The sharp uptick has been agonizing for these younger patients and many of their doctors.
    • ‘The patients wonder: Why did I develop cancer? And how will my life be transformed by potentially excruciating treatments?
    • “Their doctors share these questions, and some have additional concerns: What if these cancers had never been detected? Are doctors offering treatments to younger patients with early-stage diseases that may do as much harm as good?”
  • The Washington Post tells us,
    • “Children who returned to in-person schooling during the coronavirus pandemic saw improvements in their mental health, according to a new study that found school reopenings were associated with significant declines in diagnoses of anxiety, depression and other conditions.
    • “The findings, the study authors say, underscore that the social structure and support schools provide protected children’s mental well-being during the pandemic.
    • “Researchers from the Harvard T.H. Chan School of Public Health and Elevance Health, which is a private health insurer in California, analyzed medical claims for more than 185,000 California children ages 5 to 18 between March 2020 to June 2021. Before schools reopened about 5,200 children had a mental health diagnosis and that numbers rose to 6,500 over the course of the pandemic.
    • “But the researchers said after schools reopened, trends in mental health diagnoses, medications and spending dropped relative to trends in schools that stayed closed.”
  • Health Day informs us,
    • “The U.S. stillbirth rate dropped slightly last year, offering some hope after several years of uncertainty, according to new data from the U.S. Centers for Disease Control and Prevention (CDC).
    • “The report, released Dec. 3, found a 2% decline in stillbirths in 2024. Even with that improvement, nearly 20,000 pregnancies ended in fetal death. That’s equal to about 5.4 stillbirths for every 1,000 pregnancies lasting 20 weeks or longer.
    • “This is the lowest national rate seen in decades, although the CDC said that it does not necessarily break previous records.”
  • The American Medical Association lets us know “What doctors wish patients knew about strep throat.
    • “What is causing that sore throat? It could be strep, and it needs to be treated the right way. Two Ochsner Health physicians share more about strep throat.”
  • Per Healio,
    • “In an analysis adjusted for tobacco cigarette use, the likelihood for asthma and COPD significantly rose with daily cannabis inhalation over a 30-day period, according to results published in Journal of General Internal Medicine.
    • “I hope these results give clinicians more confidence in stating that there are serious concerns about negative health impacts of inhaling cannabis on the lungs,” Alison S. Rustagi, MD, PhD, adjunct assistant professor at University of California, San Francisco, told Healio.
    • “We don’t have enough information now to say there’s a causal link, but we also have reason to think that there may be harm to the lungs from cannabis,” she continued. “This is important for patients to know as they make health decisions.”
  • From the American Society of Hematology conference, now underway in Orlando, Florida,
    • Per BioPharma Dive,
      • “An experimental drug from Terns Pharmaceuticals is showing it may emerge as a threat to multiple established medicines for a slow-growing blood malignancy known as chronic myeloid leukemia. 
      • “According to results presented at the American Society of Hematology meeting on Monday, Terns’ drug, codenamed TERN-701, helped a majority of study participants with CML who had received previous treatments significantly reduce the number of diseased white blood cells in their bloodstream. The findings suggest the drug, a type of targeted, oral treatment, may eventually be competitive with widely used medicines like Novartis’ Scemblix, which is expected to generate more than $4 billion in peak yearly sales.”
    •  and
      • Eli Lilly was the last company to bring to market a so-called BTK inhibitor for leukemia and lymphoma. But study results revealed Sunday show Lilly’s medicine may be more effective — and potentially safer — than the oldest drug in its class. 
      • The data come from a study testing Lilly’s Jaypirca directly against AbbVie and Johnson & Johnson’s Imbruvica. Early results presented at the American Society of Hematology meeting suggest Jaypirca helped induce responses in more people with chronic lymphocytic leukemia or small lymphocytic lymphoma than Imbruvica. More definitive measures of impact — such as effects on disease progression and survival — are pointing in Jaypirca’s favor as well, though additional follow-up testing is needed to confirm those benefits.
      • “The results could be crucial in helping Lilly boost sales of Jaypirca as Imbruvica, which was launched in 2013 and has since been a regular blockbuster, approaches the end of its patent life.”
    • Per STAT News,
      • “With so-called menin inhibitors now approved for patients with certain types of advanced acute myeloid leukemia, research efforts are shifting to find uses for the genetically targeted drugs in newly diagnosed patients.
      • “Kura Oncology presented preliminary results today from a study that combines Komzifti, its menin-blocker, with two standard AML treatments. In an analysis that encompassed 40 patients with newly diagnosed, menin-susceptible AML, the triplet regimen showed a complete remission rate of 86% with a manageable safety profile.
      • “Syndax Pharma reported results from its own menin-inhibitor combination study in newly diagnosed AML patients on Saturday at the ASH meeting.”
  • Per Fierce Pharma,
    • “UCB plans to file for regulatory approval of Fintepla to treat a third epileptic condition “as soon as possible,” the company said, as it reported results of a phase 3 trial in patients with the ultra-rare cyclin-dependent kinase-like-5 (CDKL5) deficiency disorder.
    • “The study of 87 patients aged 1 to 35 with CDKL5 achieved its primary endpoint, as Fintepla demonstrated a statistically significant reduction in seizures compared with placebo. The trial also achieved two of its three secondary objectives, the Brussels-based company said at the American Epilepsy Society (AES) conference in Atlanta.
    • “Fintepla was first approved in 2020 to treat seizures associated with Dravet syndrome (DS), a rare, severe form of epilepsy that affects roughly 20,000 in the U.S. Two years later, Fintepla gained expansion into a larger epilepsy indication, Lennox-Gastaut syndrome (LGS), which affects approximately 48,000 in the U.S. In both indications, the cherry-flavored oral solution is cleared for patients age 2 and older.”
  • Per a National Institutes of Health news release,
    • “A study funded in part by the National Institutes of Health (NIH) has revealed important insights into the genetics of deposits in the eye, known as reticular pseudodrusen (RPD), that are linked to greater risk of vision loss among people with age-related macular degeneration (AMD). The study underscores that AMD is not one disease and highlights the need for novel treatment approaches.
    • “This study could help explain why drugs that target just the complement pathway have shown a minimal effect in slowing geographic atrophy,” said Anand Swaroop, Ph.D., chief of the Neurobiology Neurodegeneration and Repair Laboratory at NIH’s National Eye Institute (NEI) and a coauthor of the study report. “It’s clear that AMD involves multiple pathways that differentially synergize to generate distinct phenotypes.”
  • Per the Genetic Engineering and Biotechnology News,
    • “Terray Therapeutics has achieved its first discovery milestone in the company’s multi-target collaboration with Bristol Myers Squibb (BMS). Under the terms of the agreement, which began in 2023, Terray will discover and develop small molecule compounds against a set of targets nominated by BMS. BMS will subsequently assume responsibility for development and commercialization. 
    • “While therapeutic details of the milestone have not been disclosed, Terray describes the target as “novel and difficult to drug,” and representative of the company’s Experimentation Meets Machine Intelligence (EMMI) platform.”  
  • Beckers Hospital Review calls attention to “23 recent drug shortages and discontinuations, according to the FDA’s drug supply databases.”

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

  • Modern Healthcare unveiled its 2025 list of the top 100 most influential people in healthcare. Here are the top five:
    • 1. Sam Altman, co-founder and CEO, OpenAI
    • 2. Greg Adams, Chair and CEO, Kaiser Permanente
    • 3. Judy Faulkner, founder and CEO, EPIC Systems
    • 4. Stephen Hemsley, Chair and CEO, UnitedHealth Group
    • 5. Eugene Woods, CEO, Advocate Health
  • STAT News reports,
    • “Health insurance companies have lamented fast-rising medical expenses for more than two years. This year is no different as Americans continue to get more carethan insurers expected. 
    • “One of the main culprits of that higher spending: prescription drugs, and GLP-1s in particular.
    • “Some insurers spent more on drugs in the first nine months of this year than they did in all of 2024, financial documents analyzed by STAT show. For many, drug expenses are up more than 20% in 2025. The proliferation of GLP-1s — the injectable drug blockbusters that lead to substantial weight loss — has played a leading role and has led insurers and employers to consider whether they should stop covering them completely.” * * *
    • “Cynthia Cox, a vice president at health policy and research organization KFF who has studied health care spending across all types of health insurance markets, said GLP-1s are pressuring pretty much every insurer. “It’s not all GLP-1s, but I think a lot of the growth is,” she said.” 
  • The Wall Street Journal adds,
    • “Drugmakers are moving to sell their medicines directly to patients, abandoning the middlemen they have long relied on.
    • “The shift is a huge departure from how pharmaceutical companies including Eli Lilly, Novo Nordisk and Pfizer have sold drugs for decades and threatens the multibillion-dollar business of firms that have traditionally filled prescriptions. 
    • “It is saving some patients hundreds of dollars off the cost of prescriptions because companies have been lowering the prices for drugs sold directly. 
    • ‘Meantime, drugmakers who have been rolling out the services in recent months see a big opportunity to boost sales, though they risk losing revenue if they don’t offset lower prices by selling to more patients. 
    • “For the first time, pharma is actually looking end-to-end at the full patient journey,” said Pratap Khedkar, chief executive of pharmaceutical consulting firm ZS. “That is a very different mindset than has been the case for the last 50 years.”  
  • Brown & Brown has made available the 2026 edition of its Employer Health and Benefits Strategy Survey.
  • Fierce Healthcare tells us how “CommonSpirit Health is working to accelerate its recently launched turnaround plan.”
  • Cardiovascular Business points out,
    • “Edwards Lifesciences held its annual investor conference, predicting considerable sales growth in 2026 and highlighting the company’s continued momentum in the area of structural heart disease. Transcatheter aortic valve replacement (TAVR) and transcatheter tricuspid valve replacement (TTVR) are two areas expected to experience significant growth in the year ahead. 
    • “For 2026, Edwards Lifesciences is currently projecting overall sales growth of 8% to 10%  in addition to an adjusted earnings per share of $2.80 to $2.95. TAVR sales are expected to play a major role thanks to the continued success of its Sapien 3 platform and the planned JenaValve acquisition first announced in July 2024. In fact, the company projects TAVR sales to hit anywhere between $4.6 billion and $4.9 billion in 2026, good for a growth rate of 6% to 8%, respectively. Edwards Lifesciences also pointed to progress in the use of TAVR for patients with aortic regurgitation as a crucial step forward for patient care. 
    • “In addition, transcatheter tricuspid and mitral valve technologies are expected to hit sales of $740 million to $780 million, up 35% to 45% compared to 2025. On the tricuspid side of things, the company’s Evoque device for TTVR represents a particularly important piece of the puzzle, with two-year data on the valve expected by the second quarter of 2026.”
  • Beckers Payer Issues informs us,
    • “Elevance Health has rolled out its virtual assistant to 22 million commercial members, with a Medicare expansion planned for 2026.
    • “The tool, accessible through the Sydney Health app and affiliated plan websites, allows members to ask plain-language questions about coverage, costs, and providers. For example, members can inquire whether a surgery is covered and receive personalized cost estimates, a coverage breakdown, and a list of in-network providers, according to a Dec. 5 news release.
    • “The rollout is part of Elevance’s broader AI push across its operations. The company has deployed AI tools for internal workflows, call center automation, and clinical decision-making. The company has said it plans to invest several hundred million dollars in AI and digital initiatives.”

Weekend update

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

From Washington, DC,

  • The Senate is expected to pass S. Res. 520 which is bloc approval of over eighty nominations below the Cabinet or federal judicial level that require Senate approval.
  • Roll Call tells us about upcoming activities on Capitol Hill this week.
  • Modern Healthcare reports,
    • “States are using limited resources to mitigate the effects of rising health insurance exchange premiums and shrinking subsidies.
    • “Initiatives include financial assistance, reinsurance programs and intensified consumer outreach.
    • “Congress continues to debate whether to extend enhanced premium subsidies that expire at the end of the year.”
  • The New York Times relates,
    • “The new Dietary Guidelines for Americans will not arrive until early 2026, a representative for the Department of Health and Human Services told The New York Times on Thursday, marking a delay of the release of the government’s official advice on what to eat and drink for good health.
    • “For months, Robert F. Kennedy Jr., the nation’s health secretary, has promised to overhaul the guidelines. Federal law requires that they are updated every five years; the current edition was supposed to be replaced by the end of 2025.”
  • The Federal Benefits Open Season ends tomorrow December 8 on the following OPM established schedule:
    • “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 8, 2025 for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) and Postal Service Health Benefits Program (PSHB) ends at 11:59 pm, in the location of your electronic enrollment system, on Monday December 8, 2025.”
  • OPM’s Director Scott Kupor added a new post to his Secrets of OPM blog last Friday. Here is a link to the post which concerns employee performance management.

From the judicial front,

  • Tomorrow, the U.S. Supreme Court will hold its oral argument in Case No. 25–332, captioned Donald J. Trump, President of the United States, et al. v. Rebecca Kelly Slaughter, et al. Amy Howe, writing in the SCOTUSBlog, offers an explainer about the case.
    • “On Monday, Dec. 8, the Supreme Court will hear oral arguments in Trump v. Slaughter, a battle that has been brewing, on one hand, since soon after President Donald Trump took office in January and, on the other hand, for years. At the center of the battle are laws that limit the president’s ability to fire the heads of independent, multi-member federal agencies like the Federal Trade Commission. The president and his supporters are proponents of a doctrine known as the “unitary executive” theory – the idea that the president should have complete control over the executive branch. Under this theory, the president should be able to fire any member of the executive branch, and laws – like the one at the center of this case – that restrict his ability to do so violate the constitutional separation of powers between the three branches of government.” 
  • Federal News Network adds,
    • “A three-judge panel ruled Friday that President Donald Trump’s firings without cause of Cathy Harris and Gwynne Wilcox, Democratic members on the Merit Systems Protection Board and the National Labor Relations Board, were lawful.
    • “The split 2-to-1 panel decision of the D.C. Circuit Court of Appeals has no immediate effect, since both Harris and Wilcox’s firings were finalized in May. But Friday’s ruling comes as the Supreme Court is expected to hear arguments [on Monday December 8] on whether to overturn a 90-year-old ruling known as Humphrey’s Executor — a decision that could expand Trump’s [and future Presidents’] power to shape independent agencies.”
  • These court decisions do not affect OPM which is considered an executive agency subject to Presidential authority.

From the public health and medical / Rx research front,

  • The New York Time reports that a kidney recipient dies after transplant from organ donor who had rabies. Only four donors have transmitted rabies to organ transplant recipients since 1978, according to federal officials.
    • “Since 1978, four organ donors have passed rabies to 13 organ recipients, the report said. Of the 13 recipients, six who received treatment for rabies survived. The seven others, who did not receive treatment, died.
    • “Fewer than 10 human deaths are attributed to rabies each year in the United States, according to the C.D.C. More than 3,500 animals test positive for the virus annually.
    • “In 2024, a record 48,149 organ transplants were performed, according to the Organ Procurement and Transplantation Network, the United Network for Organ Sharing reported. The organs came from a total of 24,018 deceased and living donors.”
  • The Wall Street Journal informs us,
    • “Despite being among the great scientific breakthroughs of all time, vaccines are under fire as top government officials cast doubts on their safety. 
    • “But as doctors and vaccine deniers spar over the safety of vaccines, emerging evidence finds that some vaccines aren’t only good at preventing the disease or virus they target but also might have broader or even unrelated health benefits.” * * *
      • “The shingles vaccine might reduce dementia risk, with one study showing it averted one in five new dementia diagnoses over seven years.
      • “A Nature study found that some cancer patients who received the Covid-19 vaccine while undergoing immunotherapy had a greater survival rate than those who didn’t.
      • “The BCG tuberculosis vaccine is being studied for Alzheimer’s prevention and has been shown to decrease infant mortality.”
  • A Washington Post recounts undergoing a full body MRI as a preventive measure which by the way is not covered by health insurance.
  • From the American Society of Hematology conference, now underway in Orlando, Florida,
    • Per Fierce Pharma,
      • “Pfizer has unveiled phase 3 results that could help the company’s hemophilia drug Hympavzi level the playing field in its competition with Sanofi’s Qfitlia and Novo Nordisk’s Alhemo.
      • “After an FDA approval about a year ago for the treatment of hemophilia in patients without inhibitors, Pfizer now has detailed data showing prophylactic Hympavzi can outperform traditional therapies at controlling bleeding in patients with inhibitors.”
    • Per BioPharma DIve,
      • “Vertex Pharmaceuticals’ genetic medicine Casgevy hit an early goal in two late-stage trials focused on children with uncommon blood disorders, helping them avoid damaging vessel blockages and the need for transfusions in a setting expected to be among the first to receive an extra-speedy review from the Food and Drug Administration.
      • “The data, disclosed Saturday at the American Society of Hematology scientific meeting in Orlando, may help boost disappointing sales for Casgevy, the first therapeutic to use CRISPR gene-editing technology to modify human diseases. Casgevy is a cell therapy made from patients’ own tissues and engineered to embed in the bone marrow and stimulate a protein called fetal hemoglobin. In sickle cell disease, this protein prevents the characteristic bending that results in blockages, while, in another disorder called beta thalassemia, it can prevent anemia and the need for frequent transfusions.”
    • Per STAT News,
      • “With sales of its existing blood cancer CAR-T therapies weakening, Gilead Sciences needs anito-cel, its next CAR-T therapy for multiple myeloma — to succeed more than ever. 
      • “On Saturday at the annual meeting of the American Society of Hematology, the company and its partner Arcellx reported deepening and durable responses with no concerning safety issues in the latest analysis of a pivotal-stage clinical trial.
      • “Among 117 patients enrolled in the study, 96% showed a tumor response, with 74% of patients achieving complete remission, the companies said in a press release. 
      • “Anito-cel delayed the worsening of multiple myeloma in 67% of patients at 18 months. At the same time point, 88% of the multiple myeloma patients in the study were still alive. 
      • “None of the study participants experienced delayed neurotoxicity, including Parkinsonian symptoms and cranial nerve palsies, and there were no cases of enterocolitis, an inflammation of the intestines.”
    • and
      •  “Revuforj is a pill made by Syndax Pharma that blocks a protein called menin implicated in certain types of genetically altered acute myeloid leukemia, or AML, an aggressive and difficult-to-treat blood cancer that occurs when immature bone marrow cells fail to mature into healthy blood cells and instead start dividing uncontrollably.
      • “For now, Revuforj is approved for patients with menin-susceptible AML that is no longer responsive to other therapies. On Saturday, however, a researcher presented preliminary study results showing strong efficacy for an experimental Revuforj combination regimen in patients with newly diagnosed AML.”

From the U.S. healthcare business front,

  • Kaufman Hall reports
    • “The most recent National Hospital Flash Report highlights stabilizing hospital margins, with a persistent gap in hospital performance, according to September 2025 data. Year to date margins range from 14.7% for hospitals performing at the top quartile to -1.8% at the lowest quartile, with the 50th percentile at approximately 2.9% when adjusted for the allocations to hospitals from corporate, physician, and other entities.
    • “September saw also month-over-month and year-over-year increases in inpatient discharges, patient days and emergency department visits. With patient volumes moderately increasing year over year, the ability of hospitals to manage patient throughput efficiently is more important than ever.”
  • Kaufman Hall also offers advice to hospitals and payers about recent and potential site neutral payment developments.
  • Modern Healthcare points out,
    • “Prime Healthcare Foundation has decided not to acquire two Prospect Medical Holdings hospitals in Rhode Island. 
    • “Prospect Medical Holdings has filed a motion to close the facilities if a buyer is not found.”
  • Per Becker Payer Issues,
    • “This year, Elevance Health began covering doula care for members of some employer-sponsored health plans. Cynthia Brown, MD, medical director and clinical lead for women’s health at Elevance Health, joined the Becker’s Payer Issues podcast for an upcoming episode on her team’s push for doula coverage.” 

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “The Trump administration is aiming to release its six-part national cybersecurity strategy in January, according to multiple sources familiar with the document. The document, which is a mere five pages long, will possibly be followed by an executive order to implement the new strategy.
    • “The administration has been soliciting feedback in recent days, which one source considered more of a “messaging” document than anything, with more important work to follow.
    • “According to sources familiar with the strategy, the six “pillars” focus on cyber offense and deterrence; aligning regulations to make them more uniform; bolstering the cyber workforce; federal procurement; critical infrastructure protection; and emerging technologies.”
  • and
    • “A bipartisan group of senators are looking to tackle health care cybersecurity by reviving legislation that would update regulations and guidelines, authorize grants, offer training and clarify federal agency roles.
    • “It’s a subset of cybersecurity where Congress hasn’t enacted any sweeping changes to date. The resurrected Health Care Cybersecurity and Resiliency Act from Health, Education Labor and Pension Committee Chairman Bill Cassidy, R-La., and his colleagues on both sides of the aisle emerges from a 2023 bipartisan health care cybersecurity working group.
    • “Cassidy and his cosponsors — Mark Warner, D-Va., Maggie Hassan, D-N.H., and John Cornyn, R-Tex. — first introduced the bill in late November last year, with little time left in the session to take action on it before Congress adjourned at the beginning of 2025.
    • “Cyberattacks in the health care sector can have a wide range of devastating consequences, from exposing private medical information to disrupting care in ERs — and it can be particularly difficult for medical providers in rural communities with fewer resources to prevent and respond to these attacks,” Hassan said in a news release Thursday.”
  • and
    • “Sean Plankey’s nomination to lead the Cybersecurity and Infrastructure Security Agency looks to be over following his exclusion from a Senate vote Thursday [December 4, 2025} to move forward on a panel of Trump administration picks.
    • “Multiple senators placed holds or threatened holds on his nomination, some related to cybersecurity. But the hold from Sen. Rick Scott, R-Fla., appeared to be the biggest hurdle. With Plankey’s exclusion from the resolution to advance a bevy of nominees that got a key vote Thursday, procedural issues make it unlikely that he will be the nominee going forward, sources told CyberScoop. The administration would have to re-submit his name for nomination next year.
    • “Scott’s hold was related to Department of Homeland Security Secretary Kristi Noem partially terminating a Coast Guard cutter program contract with Florida-based Eastern Shipbuilding Group, multiple sources told CyberScoop. The Government Accountability Office issued a critical report on the program.
    • “While awaiting confirmation, Plankey, a 13-year Coast Guard officer, has been serving as senior adviser to the secretary for the Coast Guard.” 
  • Cybersecurity Dive tells us,
    • “A pair of U.S. senators wants to know how the government is tracking and responding to hackers’ use of AI platforms to conduct cyberattacks.
    • “The emerging threat to U.S. cybersecurity posed by foreign adversaries deploying autonomous AI systems requires a robust response from your office and other federal agencies,” Sens. Maggie Hassan, D-N.H., and Joni Ernst, R-Iowa, wrote in a Tuesday letter to National Cyber Director Sean Cairncross.
    • “The bipartisan letter comes several weeks after Anthropic revealed that Chinese government-linked hackers had manipulated the company’s Claude platform into breaching companies and government agencies around the world. The attack, which Anthropic called “the first documented case of a large-scale cyberattack executed without substantial human intervention,” has exacerbated worries within the security community about the growing offensive capabilities of AI tools.”
  • In this regard, Cyberscoop calls attention to “More evidence your AI agents can be turned against you Aikido found that AI coding tools from Google, Anthropic, OpenAI and others regularly embed untrusted prompts into software development workflows.”
  • Dark Reading relates,
    • “[On December 3, 2025,] [a] collection of agencies published guidance on the best way to defend AI deployments in operational technology (OT). 
    • “Such guidance seems necessary, given that on their own, AI and OT environments are two of the most sensitive, high-profile attack surfaces. AI is a prime target, due to the wide range of attack techniques emerging constantly, and OT because of its use in critical and industrial settings.
    • “The guidance was authored by the US’s CISA, FBI, and NSA Artificial Intelligence Security Center; the Australian Signals Directorate’s Australian Cyber Security Centre; the Canadian Centre for Cyber Security; the German Federal Office for Information Security; the Netherlands National Cyber Security Centre; the New Zealand National Cyber Security Centre; and the UK’s National Cyber Security Centre.”
  • Cybersecurity Dive informs us,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) is eliminating a program it used to retain uniquely valuable security professionals after an audit found that the agency had mismanaged the program.
    • “In 2015, CISA’s predecessor inside the Department of Homeland Security created the Cybersecurity Retention Incentive (CRI) program to offer extra money to employees who were likely to leave the government for higher-paying private-sector jobs. CRI incentives were intended to apply only to a narrow subset of CISA employees with specialized cybersecurity skills. But, in September, the DHS inspector general found that CISA was offering the incentives too broadly.
    • “In a statement to Cybersecurity Dive, CISA said it would soon end the CRI program.”
  • Per a December 4, 2025, CISA news release,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) launched a new Industry Engagement Platform (IEP) today designed to facilitate structured, two-way communication between the agency and companies developing innovative and security technologies. The IEP enables CISA to better understand emerging solutions across the technology ecosystem while giving industry a clear, transparent pathway to engage with the agency.
    • “With the launch of this new platform, we’re opening the door wider to innovation—giving industry a direct line to share the tools and technologies that can help CISA stay ahead of evolving threats,” said CISA Acting Director Madhu Gottumukkala. “The private sector drives innovation and this collaboration is essential to our national resilience.”
    • “The IEP allows organizations – including industry, non-profits, academia, government partners at all and the research community – with a structured process to request conversations with CISA subject matter experts to describe new technologies and capabilities. These engagements give innovators the opportunity to present solutions that may strengthen our nation’s cyber and infrastructure security.”
  • Cyberscoop relates,
    • “Twin brothers Muneeb and Sohaib Akhter were arrested in Alexandria, Va., Wednesday [December 3, 2025} for allegedly stealing and destroying government data held by a government contractor minutes after they were fired from the company earlier this year, the Justice Department said.
    • “Prosecutors accuse the 34-year-old brothers of the crimes during a weeklong spree in February, compromising data from multiple federal agencies including the Department of Homeland Security, Internal Revenue Service and the Equal Employment Opportunity Commission.
    • “Authorities did not name the federal government contractor, which provides services and hosts data for more than 45 federal agencies, but the company was previously identified as Washington-based Opexus in a Bloomberg report about the insider attack earlier this year. Opexus did not immediately respond to a request for comment.”
  • Security Week notes,
    • “The cryptocurrency mixer Cryptomixer has been shut down by law enforcement agencies in Europe for facilitating cybercrime and money laundering, Europol announced on Monday [December 1, 2025}.
    • “Accessible both from the clear and the dark web, Cryptomixer was a mixing service (tumbler) designed to help customers obscure the trail of their cryptocurrency by combining their deposits with those from other users into a large, pooled fund before sending back an equivalent amount of untraceable coins to a wallet specified by the customer.”

From the cybersecurity breaches and vulnerabilities front,

  • Bleeping Computer reports,
    • “Earlier today [December 5, 2025], Cloudflare experienced a widespread outage that caused websites and online platforms worldwide to go down, returning a “500 Internal Server Error” message.
    • “The internet infrastructure company has now blamed the incident on the rollout of emergency mitigations designed to address a critical remote code execution vulnerability in React Server Components, which is now actively exploited in attacks.
    • “The issue was not caused, directly or indirectly, by a cyber attack on Cloudflare’s systems or malicious activity of any kind. Instead, it was triggered by changes being made to our body parsing logic while attempting to detect and mitigate an industry-wide vulnerability disclosed this week in React Server Components,” Cloudflare CTO Dane Knecht noted in a post-mortem.
    • “A subset of customers were impacted, accounting for approximately 28% of all HTTP traffic served by Cloudflare.”
  • and
    • “Financial software provider Marquis Software Solutions is warning that it suffered a data breach that impacted dozens of banks and credit unions across the US.
    • “Marquis Software Solutions provides data analytics, CRM tools, compliance reporting, and digital marketing services to over 700 banks, credit unions, and mortgage lenders.
    • “In data breach notifications filed with US Attorney General offices, Marquis says it suffered a ransomware attack on August 14, 2025, after its network was breached through its SonicWall firewall.
    • “This allowed the hackers to steal “certain files from its systems” during the attack.
    • “The review determined that the files contained personal information received from certain business customers,” reads a notification filed with Maine’s AG office.”
  • Cyberscoop relates,
    • “Cybersecurity authorities and threat analysts unveiled alarming details Thursday [December 4, 2025] about a suspected China state-sponsored espionage and data theft campaign that Google previously warned about in September. The outlook based on their limited visibility into China’s sustained ability to burrow into critical infrastructure and government agency networks undetected, dating back to at least 2022, is grim.
    • “State-sponsored actors are not just infiltrating networks, they are embedding themselves to enable long-term access, disruptions and potential sabotage,” Nick Andersen, executive assistant director for cybersecurity at the Cybersecurity and Infrastructure Security Agency, said during a media briefing.
    • “Brickstorm, a backdoor which Andersen described as a “terribly sophisticated piece of malware,” has allowed the attackers to achieve persistent access with an average duration of 393 days to support immediate data theft and follow-on pivots to other malicious activity, Austin Larsen, principal analyst at Google Threat Intelligence Group, told CyberScoop.
    • “We believe dozens of organizations in the United States have been impacted by Brickstorm, not including downstream victims,” Larsen said.
    • “CISA, the National Security Agency and the Canadian Centre for Cyber Security released an analysis report on Brickstorm, which targets VMware vSphere and Windows environments to conceal activity, achieve lateral movement and tunnel into victim networks while also automatically reinstalling or restarting the malware if disrupted. CISA provided indicators of compromise based on eight Brickstorm samples it obtained from victim organizations.”
  • Cybersecurity Dive adds,
    • “A China-nexus threat actor hacked into VMware vCenter environments at U.S.-based companies before deploying Brickstorm malware, security firm CrowdStrike warned in a blog post published Thursday.
    • “The threat actor, tracked under the name Warp Panda, targeted multiple industries during the summer of 2025, including legal, technology and manufacturing firms. 
    • “Warp Panda has targeted entities mainly in North America and Asia Pacific in an effort to support strategic objectives of the Chinese Communist Party, according to CrowdStrike. These include economic competition, advancing their technology and growing regional influence.”
  • CISA added four known exploited vulnerabilities to its catalog this week.
  • Per Bleeping Computer,
    • An ongoing phishing campaign impersonates popular brands, such as Unilever, Disney, MasterCard, LVMH, and Uber, in Calendly-themed lures to steal Google Workspace and Facebook business account credentials.
    • Although threat actors targeting business ad manager accounts isn’t new, the campaign discovered by Push Security is highly targeted, with professionally crafted lures that create conditions for high success rates.
    • Access to marketing accounts gives threat actors a springboard to launch malvertising campaigns for AiTM phishing, malware distribution, and ClickFix attacks.
  • Cybersecurity Dive notes,
    • “Distributed denial of service attacks rose sharply during the third-quarter, fueled by record-level attacks from the Aisuru botnet, comprising between one and four million hosts across the globe, according to a report released Wednesday by Cloudflare. 
    • “The number of attacks rose 54% quarter over quarter, averaging about 14 hyper-volumetric attacks daily, according to Cloudflare. Researchers called the scale of these attacks “unprecedented,” reaching 29.7 terabits per second and 14.1 billion packets per second. 
    • “The record-breaking 29.7 Tbps attack was a User Datagram Protocol carpet-bombing attack that hit an average of 15,000 destination ports per second, according to Cloudflare. 
    • “Aisuru targeted a number of critical industries, including telecommunications, financial services, hosting providers and gaming companies.” 

From the ransomware front,

  • Dark Reading warns us,
    • “The Ransomware Holiday Bind: Burnout or Be Vulnerable
    • “Ransomware groups target enterprises during off-hours, weekends, and holidays when security teams are stretched thin and response times lag.”
  • Per Bleeping Computer,
    • “American pharmaceutical firm Inotiv is notifying thousands of people that they’re personal information was stolen in an August 2025 ransomware attack.
    • “Inotiv is an Indiana-based contract research organization specializing in drug development, discovery, and safety assessment, as well as live-animal research modeling. The company has about 2,000 employees and an annual revenue exceeding $500 million.
    • “When it disclosed the incident, Inotiv said that the attack had disrupted business operations after some of its networks and systems (including databases and internal applications) were taken down.
    • “Earlier this week, the company revealed in a filing with the U.S. Securities and Exchange Commission (SEC) that it has “restored availability and access” to impacted networks and systems and that it’s now sending data breach notifications to 9,542 individuals whose data was stolen in the August ransomware attack.
    • “Our investigation determined that between approximately August 5-8, 2025, a threat actor gained unauthorized access to Inotiv’s systems and may have acquired certain data,” it says in letter samples filed with Maine’s attorney general.”
  • Help Net Security explains “how a noisy ransomware intrusion exposed a long-term espionage foothold.”
    • “Getting breached by two separate and likely unconnected cyber attack groups is a nightmare scenario for any organization, but can result in an unexpected silver lining: the noisier intrusion can draw attention to a far stealthier threat that might otherwise linger undetected for months.”
  • CXO Revolutionaries offers management lessons from the ransomware attack against the State of Nevada this past summer.

From the cybersecurity business and defenses front,

  • SC Media reports,
    • “Cybersecurity startup 7AI announced Dec. 4 that it raised $130 million in Series A funding 10 months after emerging from stealth in February. 
    • “The funding round is the largest Series A in history for cybersecurity, the company stated in its announcement, and brings its total amount raised to $166 million. 7AI was founded by two former executives and founders of the security firm Cybereason, former CEO Lior Div and former CTO Yonatan Striem-Amit.
    • “We’re at an agentic security inflection point that changes the equation entirely. Instead of security teams drowning in investigations that take hours, our AI agents complete them in minutes at a speed, accuracy, and consistency that’s difficult for humans and automation to match,” Div said. “… We have the proof, and it’s in production right now: our AI agents do the investigation work so security teams can finally do human work: strategic threat hunting, proactive security and innovation through AI transformation.”
    • “Over the last 10 months, the company said its AI agents processed more than 2.5 million alerts and completed over 650,000 security investigations for its clients. Customers reported saving between 30 minutes and 2.5 hours per investigation, and eliminated up to 99% of false positives in production.”
  • Dark Reading discusses “How Agentic AI Can Boost Cyber Defense. Transurban head of cyber defense Muhammad Ali Paracha shares how his team is automating the triaging and scoring of security threats as part of the Black Hat Middle East conference.”
  • The American Hospital Association News relates,
    • “The FBI has public resources available to help prevent exploitation by cybercriminals, who use artificial intelligence for deception. An infographic by the FBI and the American Bankers Association Foundation highlights how AI-generated or manipulated media, also known as “deep fakes,” can be used to impersonate trusted individuals. It details signs of a deep fake scam and how such content can depict public figures, friends and family members. An FBI announcement further explains how criminals use AI-generated text, images, audio and video for fraud schemes. The alert includes tips to help protect against suspected schemes.
    • “The information provided by the FBI and the ABA is relevant for health care as criminals are increasingly using AI-generated deep fake audio and video content — often in combination — to deceive health care staff,” said John Riggi, AHA national advisor for cybersecurity and risk. “Deep fakes are used to manipulate unwitting individuals by having them click on phishing emails, provide their credentials, hire malicious remote IT workers or transfer funds to criminal accounts. Constant vigilance and multi-layered human verification processes are needed, especially as AI-synthetic video and audio capabilities continue to advance.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

David Ermer–ACA, CDC, Congress, Electronic health records, FDA, Government Contracting, OPM, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “A dispute over a Trump administration plan to consolidate federal firefighting operations may be close to resolution, in a sign of modest progress toward Senate passage of a major fiscal 2026 spending package.
    • “Sen. Tim Sheehy, R-Mont., said Thursday he was prepared to release his hold on the Interior-Environment bill, a prime candidate for the “minibus” spending package, after cutting a deal to remove language that threatened to delay, if not derail, the firefighting reorganization.
    • “Sheehy, a former firefighting pilot and founder of an aerial firefighting and aerospace services company, is a key backer of the plan and rejected any effort to delay it.
    • “But we’ve cleared that language, so we should be good now,” he said.” * * *
    • “While Sheehy’s hold on the spending package may be lifted, Thune continued to negotiate with several other Republicans who have their own holds as they push for various causes, including a concern from some conservatives that spending levels are too high.
    • “Thune, R-S.D., told reporters Thursday that negotiators were still working “through the concerns that our members have,” but added he’s hopeful they “can land something soon.”
    • “A lot of conversations going on around that, but we just need to — we’ve got to get on the package of bills,” Thune said.
    • “Thune wants to add some combination of the Commerce-Justice-Science, Interior-Environment, Labor-HHS-Education and Transportation-HUD bills to the Defense bill in a package he could bring to the floor in coming days.”
  • Fierce Healthcare adds,
    • “As Congress continues to debate next steps on the Affordable Care Act’s enhanced subsidies, insurers are urging legislators to consider an extension with additional program integrity measures in place.
    • “AHIP said in a statement Wednesday that “common sense” steps to promote integrity can help mitigate the risks related to fraudulent enrollment in ACA plans or subsidies. The commentary comes after analysts at the Government Accountability Office were largely able to enroll in coverage and in the tax credits using fake profiles.
    • “GAO notes in the report that when the Centers for Medicare & Medicaid Services took steps to address fraudulent enrollments by improving identity verification and implementing three-way calls to stymie broker misbehavior, which have already had an impact on reducing unauthorized activity, AHIP said.
    • “With open enrollment underway and 24 million Americans facing the largest-ever spike in healthcare costs in 2026, Congress should take bipartisan action to preserve the health care tax credits and further strengthen program integrity,” AHIP said.”
  • The American Hospital Association News tells us,
    • “The Advisory Committee on Immunization Practices Dec. 5 recommended individual-based decision-making for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. If not receiving the vaccine at birth, ACIP recommended infants receive the initial dose no earlier than 2 months of age. However, ACIP made no change to the existing Centers for Disease Control and Prevention recommendations to vaccinate infants born to women who test positive for the virus or have an unknown virus status. The recommendations also maintain consistency with all current health coverage options for payment, according to the Department of Health and Human Services. ACIP’s recommendations must be formally adopted by the director of the CDC before becoming part of the CDC immunization schedule.”
  • The Wall Street Journal explains what the ACIP recommendations means for readers.
    • “Under these recommendations, parents who wish to have their infants vaccinated at birth, if the mother isn’t infected with hepatitis B, will be able to do so after discussing it with their doctor. Doctors might face additional hurdles in administering the vaccine at birth for some families, including additional time spent counseling. 
    • “Insurers will likely still cover the shots if administered earlier than recommended. AHIP, a group representing insurers, said its members will cover vaccines recommended by ACIP through Sept. 1 until the end of 2026. Insurers typically handle coverage decisions yearly.”
  • Healthcare Dive lets us know,
    • “The HHS on Thursday released its plan to deploy and centralize artificial intelligence use within the agency, as part of a broader push by the Trump administration to cut costs and adopt the technology in the federal government.
    • “The agency said it will prioritize sharing AI resources among HHS departments, create a governance structure for new tools and promote use of the technology for public health initiatives.
    • “Although the strategy is internally focused to start, HHS said it will collaborate with the private sector and identify “priority” conditions and health issues that could be addressed with AI tools.” 
  • FedWeek calls to our attention a hiccup in the relatively new PSHBP Open Enrollment system that may require enrollee work arounds.

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.
    • “Developed by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
    • “We are piloting an approach to encourage the use of digital technologies that meet people where they are,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”
  • Per MedTech Dive,
    • “Advisers to the Food and Drug Administration on Wednesday voted 15-0 against use of Johnson & Johnson’s V-Wave shunt for heart failure patients not helped by medications.
    • “Members of the circulatory system devices panel were unanimously opposed to recommending approval of the implant based on effectiveness and its benefit-risk profile. On the question of safety, the panelists voted 9-6 in favor of the device.
    • “J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the agency makes the final decisions.
    • “Following the vote, a J&J spokesperson said the company is reviewing the FDA advisory panel’s recommendation for additional clinical evidence on the device.
    • “We will continue to work closely with the FDA, clinicians and other stakeholders to determine next steps,” the spokesperson wrote in an email.”

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 is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
      • “Seasonal influenza activity is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “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 University of Minnesota’s CIDRAP adds
    • “Although this year’s flu season could be challenging, fewer adults have been vaccinated against influenza, a new study shows.
    • “Much less than half of US adults have been immunized against any respiratory virus, according to a survey of 1,015 adults released this week by the National Foundation for Infectious Diseases (NFID).
    • “Just 34% of adults have gotten a flu shot; 25% have had a COVID-19 shot; 8% have received a vaccine to prevent pneumococcal disease, caused by bacteria that can lead to pneumonia, meningitis, and sepsis; and 6% have been vaccinated against respiratory syncytial (RSV), a leading cause of hospitalization in infants and older adults.
    • “New data from IQVIA, which provides health care statistics, show similar declines over the past year. Retail pharmacies have seen falling numbers of vaccinations for three major respiratory viruses:
      • “34% decline in RSV vaccinations
      • “27% drop in COVID-19 vaccinations
      • “6% reduction in flu shots
    • “Pneumococcal vaccinations are the one bright spot in IQVIA’s data, with vaccinations rising 27% in the past year. The uptick is likely due to the Centers for Disease Control and Prevention’s (CDC’s) decision last year to lower the age at which people are eligible for pneumococcal vaccine from 65 to 50, said Robert Hopkins, NFID’s medical director.
  • Beckers Clinical Leadership tells us,
    • “Twelve percent of nearly 3,000 norovirus tests during the week ending Nov. 22 came back positive — a notable increase from the 6.82% positivity rate three months earlier, according to CDC data. 
    • “During the week ending Aug. 23, 6.82% of 4,034 norovirus tests were positive. A CDC system that tracks viral activity in the U.S. shows a 12% positivity rate among 2,825 norovirus tests, as of Nov. 22, the most recent data available.” 
  • Per Medscape,
    • “A newly cleared point-of-care test will enable rapid identification of whooping cough, according to a press release from manufacturer Roche.
    • “The molecular test uses the cobas liat system and earned an FDA clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for the detection of Bordetella infections, including pertussis.
    • “The CLIA waiver means that the test is approved for use in settings outside of a traditional lab, including a doctor’s office or pharmacy, and is considered sufficiently simple that it can be performed by healthcare personnel without extensive medical training.
    • “The test is currently available and provides polymerase chain reaction (PCR) results after approximately 15 minutes at the point of care, according to the company. Early symptoms of pertussis are similar to other respiratory illnesses, and a quick-turn test can confirm a diagnosis and facilitate timely treatment to prevent further spread of illness and protect patients from severe complications.”
  • and
    • “Current cardiac screening tools used to prevent myocardial infarction (MI) failed to identify nearly half of people who are at risk for MI, according to a new study. Those patients had low or borderline risk as per both standard and newer risk calculators for atherosclerotic cardiovascular disease (ASCVD). Most developed symptoms within 48 hours before the event, and many would not have been recommended statins or further testing if evaluated 2 days earlier.”
  • MedPage Today informs us,
    • “In a French cohort, the incidence of all-cause mortality among those who received a first dose of an mRNA COVID vaccine was 0.4% after a median follow-up of 45 months, compared with 0.6% of those who were unvaccinated.
    • “After standardizing characteristics between the two groups, all-cause mortality incidence was 25% lower in those who had received a COVID shot.
    • “Vaccinated people were 74% less likely to die in a hospital because of COVID-19 compared with those who weren’t vaccinated.”
  • and
    • “Three ancillary studies to the U.S. POINTER trial collectively demonstrated that a structured 2-year lifestyle intervention for older adults at increased risk of cognitive decline led to better overall health.
    • “In main results from the U.S. POINTER trial released in July, two lifestyle interventions — one structured, the other self-guided — improved cognitive scores in over 2,000 older adults, said Rema Raman, PhD, of the University of Southern California in Los Angeles, who co-chaired a symposium at the Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting.
    • “Both 2-year interventions in U.S. POINTER encouraged physical activity, cognitive activity, healthy diet, social engagement, and cardiovascular health monitoring, but they differed in structure, intensity, and accountability.
  • Per Health Day,
    • “Your brain health might be linked to how well your kidneys are working, a new study says.
    • “People with impaired kidney function have higher levels of proteins in their blood that are linked to Alzheimer’s disease, researchers reported Dec. 4 in the journal Neurology.
    • “Our study found that when the kidneys are not functioning properly, there may be higher levels of Alzheimer’s biomarkers in the blood,” lead researcher Dr. Francesca Gasparini, a geriatrician with the Karolinska Institutet in Stockholm, Sweden, said in a news release.
    • “While we did not find that having reduced kidney function increased the risk of developing dementia, we did find that impaired kidney function may accelerate the onset of dementia in people who have higher levels of biomarkers.,” Gasparini said. “This highlights the need for doctors to consider kidney function when interpreting results of Alzheimer’s biomarkers in the blood.”
  • STAT News reports,
    • “Boehringer Ingelheim this week provided more details about a late stage clinical trial of an app designed to treat under-addressed symptoms of schizophrenia and revealed the company is preparing to submit the app to the Food and Drug Administration for clearance.
    • “Developed with Click Therapeutics, the app, CT-155, is a 16-week treatment that adapts key elements of established face-to-face psychosocial treatments for schizophrenia as an adjunct to antipsychotic drug treatment. Schizophrenia affects millions of people in the U.S. and is commonly associated with psychotic behavior and delusions. However, there are other common and often serious negative symptoms, including lack of motivation and the inability to experience pleasure, for which there are no approved drugs.”

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

  • Tech Target relates,
    • “Navigating an evolving regulatory landscape is top-of-mind for healthcare payers heading into 2026, with health plan executives saying changing requirements stemming from the Trump tax law has driven new priorities, according to a new HealthEdge report.
    • “The report, based on survey responses from 550 health plan executives in the United States, also flagged rising costs, better member engagement, investment in artificial intelligence (AI) and more collaborative payer-provider relationships as key priorities.”
  • McKinsey & Co. points out,
    • “Women in the United States face steeper barriers to healthcare than men, causing preventable suffering and costing billions each year. The health of women—encompassing the entire care continuum and extending beyond reproductive and sexual health—represents an approximately $50 billion missed annual opportunity for health systems nationally. Addressing the gap in women’s healthcare requires a fundamental transformation in care delivery, with preventive care playing a pivotal role to ensure accessibility, continuity, and comprehensive care.”
  • BioPharma Dive notes,
    • “Hemophilia gene therapies are struggling on the market, even as innovation soars. The business case for hemophilia gene therapy still isn’t adding up due to persistent market barriers.”
  • Per Fierce Healthcare,
    • “It’s been just over a year since Oura announced a partnership with Medicare Advantage insurer Essence Healthcare, and, now, the partners are looking to continue building on that foundation.
    • “The partnership initially launched for Essence’s PPO plan members, and, over the course of the year, grew into HMO plans as well. Saria Saccocio, M.D., chief medical officer for Essence, told Fierce Healthcare that a third of members who were eligible for an Oura ring chose to sign up, and two-thirds of that group was willing to share biometric data with the insurer.
    • “She said the effort began with sleep health and, over time, has shown members are improving their sleep scores. That’s translating to other areas as well, such as an increase in the amount of time engaging in light exercise.
    • “It’s that level of awareness and nudge that I think is helping improve the overall health of our members,” Saccocio said.”
  • and
    • “Wellvana has struck a 20-year affiliation with Mercy that will offer the system’s nonemployed primary care physicians and advanced practice providers participation in value-based care.
    • “The arrangement will give those independent clinicians access to Wellvana’s electronic-health-record-integrated practice tools and clinical and operational care teams, which the new partners say will reduce administrative burdens and help coordinate patient care.
    • “The providers’ participation in value-based arrangements will also bring financial incentives for better patient outcomes within Mercy’s service area and across Medicare, Medicare Advantage and commercial plans, they said. The organizations expect their clinically integrated network to be among the country’s largest.
    • “Mercy has built one of the nation’s most respected systems, and together we’re creating sustainable paths for independent providers to see the rewards of accountable care,” Wellvana CEO Susan Diamond said in Thursday’s announcement. “The more we grow participation in value-based care, the more patients and communities benefit from a better, more connected health experience.”
  • The Wall Street Journal offers readers six questions to ask their doctors before their doctors use AI to record their visits.

Thursday report

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

From Washington, DC,

  • Modern Healthcare reports,
    • “Enhanced subsidies for health insurance exchange plans would be extended for three years under a plan Senate Minority Leader Chuck Schumer (D-N.Y.) announced Thursday.
    • “The enhanced premium tax credits for marketplace policies expire at the end of the year, leading to significant cost increases for exchange enrollees in 2026. The Senate Democrats who sided with the Republican majority to end the government shutdown last month secured a promise from Majority Leader John Thune (R-S.D.) to hold a vote on the issue, which is slated for next week.
    • “Schumer described the Senate measure, which mirrors a House Democratic plan, as a “clean” extension that wouldn’t make other changes to Affordable Care Act of 2010 programs.
  • Fierce Healthcare adds,
    • “Congress is running out of time to address the expiring Affordable Care Act subsidies before many individuals are exposed to massive cost increases Jan. 1, and new plans are emerging on the Hill to tackle the challenge.
    • “A bipartisan group of 35 legislators—including 15 Republicans—in the House has introduced a plan that would extend the tax credits for one year with some modifications, such as a new income limit, according to a report in The New York Times. 
    • “The proposal also includes a second shift in year two, implementing more substantial reforms such as eliminating $0 premium plans except in cases where there is a need. Each piece of the plan would require a separate congressional vote, the NYT reported.
    • “Rep. Josh Gottheimer, D-N.J., said the lawmakers are urging for a vote on the package by Dec. 18 to “get something done before premiums rise in January,” per the NYT. Most of the Republicans who have signed on to the package represent districts where the race is expected to be competitive in the midterms next year, according to the article.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, is cosponsoring legislation alongside Finance Chairman Mike Crapo (R-Idaho), Ranking Member Ron Wyden (D-Ore.) and 18 senators to improve accountability and oversight of pharmacy benefit managers (PBMs) and bring down the price of prescription drugs for Americans. Grassley is an original cosponsor of the legislation, called the PBM Price Transparency and Accountability Act.
    • “Iowans at my 99 county meetings are fed up with the high cost of prescription drugs, and for good reason. PBMs are driving local pharmacies in Iowa out of business and making it harder for Iowans to access the medications they need. That’s why I’m introducing legislation with my colleagues to put patients over pharmacy benefit managers by shining a light on the complex and opaque tactics these middlemen use. This landmark bill builds on the bipartisan legislation I spearheaded during my time as Finance Chairman, and includes several proposals I helped craft,” Grassley said.
    • “The Grassley–led provisions included in the bill would:
      • “Increase PBM reporting requirements to Medicare Part D plan sponsors and the Department of Health and Human Services;
      • “Require retail community pharmacies and certain other pharmacies to participate in the National Average Drug Acquisition Cost (NADAC) survey; and
      • “Ban PBM spread pricing in the Medicaid program.”
  • Fierce Pharma tells us,
    • “The Centers for Disease Control and Prevention’s (CDC’s) newly reworked Advisory Committee on Immunization Practices (ACIP) met Thursday to finally offer its recommendations for a universal hepatitis B virus (HBV) vaccine for newborns, only to fall to the same pattern of debate and uncertainty that derailed its last attempt to vote on the matter.
    • ‘Day one of the ACIP’s meeting this week was meant to pick up where the committee left off on the HBV topic during its September meeting, when it scrapped its planned vote amid confusion on specific voting language. The committee was scheduled to officially clear the air with a vote Thursday afternoon, following a morning of discussion and commentary from stakeholders, according to the final agenda.
    • “Things didn’t quite go to plan, however. After a few hours of debate on the voting language at hand, the only vote that occurred Thursday was a 6-3 agreement on a motion to push back the HBV vote until Friday morning.” * * *
    • “A planned HBV vote Friday will further crowd the schedule for the day, which is set to include additional discussion on the childhood immunization schedule, comparisons to the Danish vaccine schedule and a presentation on “aluminum exposure” from childhood vaccines and potential implications for asthma later in life, the agenda reads.” 
  • The American Hospital Association News notes,
    • “The AHA released a report Dec. 4 that found patient safety in hospitals and health systems across the nation continues to improve. The report, which uses data analyzed by Vizient, examined key safety and quality metrics from the fourth quarter of 2019 to the second quarter of 2025. It found that despite caring for a sicker patient population, hospitals’ focus on safety led to improved patient outcomes and reduced infections.” 

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, FDA Commissioner Marty Makary told STAT on Wednesday. 
    • “While historically the FDA has required two trials for added assurance of a drug’s safety and efficacy, it has become increasingly flexible and many drugmakers already submit just one pivotal clinical trial for approval. Makary said that while the agency will still require two in some cases, the default will be one trial.
    • “You can achieve the same statistical power with one trial as you would with two trials when it’s designed and controlled appropriately,” Makary told STAT by phone.” * * *  
    • “The agency will publish a press release soon, a spokesperson told STAT. Makary said the agency will also start updating policies to reflect the change, which could take three to six months. The change will take effect once the guidance is updated.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S. for treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy. Breyanzi is a chimeric antigen receptor CAR T-cell therapy that genetically engineers a patient’s own T-cells to target and kill cancer cells.”
  • Per MedTech Dive,
    • “Medtronic said Wednesday it obtained U.S. clearance for its Hugo system in urologic procedures, positioning the medtech giant to challenge Intuitive Surgical in the world’s largest robotic surgery market.
    • “In addition to the initial urology indication, which includes common procedures such as prostate removal, the company plans to extend use of the robot to more surgical specialties in the U.S. over time, with general surgery and gynecology expected to follow next.
    • “The Food and Drug Administration clearance “means there is now choice” for hospitals looking to expand their robotic programs, Rajit Kamal, Medtronic’s vice president and general manager of robotic surgical technologies, said in a statement.”
  • and
    • “Olympus has updated the instructions for a device used with endoscopes to prevent or control bleeding, the Food and Drug Administration said Wednesday.
    • “As of Oct. 1, Olympus had reported 113 serious injuries and no deaths associated with problems releasing or detaching its PolyLoop ligation loop device, according to the FDA and its Australian counterpart.
    • “The FDA categorized the correction as a Class I recall because of the potential for the problems to result in severe tissue injury, bleeding, perforation, additional surgical intervention, extensive procedural delays and hospitalization.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has announced that Glycar SA, a South African medical device company, is recalling certain SJM Pericardial Patches with EnCap Technology due to potential issues with their strength and durability.
    • “The recall only covers one specific lot of these patches: lot T2502257. That lot included some devices that are 5 cm x 10 cm and others that are 9 cm x 14 cm. 
    • “The impacted lot may not meet the required tensile strength specification,” according to the FDA’s advisory. “Possible change in tensile strength is not detectable to the user intraoperatively. Postoperative loss of the patch’s mechanical properties causing dehiscence or rupture may require reintervention or reoperation, depending on the clinical indication that the patch was used for.”
    • “This is a Class I recall, which means the FDA believes using these devices could cause “serious adverse health consequences or death.” At this time, however, no serious injuries or deaths have been linked to the issue.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court cleared Texas to use a new Republican-drawn congressional map for next year’s election, bolstering GOP hopes of picking up as many as five new House seats in the state.
    • “Over three dissents, the justices lifted a lower court ruling that had blocked the map, which was drawn at President Donald Trump’s behest to help Republicans try to keep their House majority in the midterm election.
    • “The Supreme Court order applies only until the justices resolve the state’s appeal, and the decision doesn’t dictate whether the map can be used beyond 2026. 
    • “The unusual Texas mid-decade redistricting set off a partisan fight across the nation, prompting about a dozen states to either redraw their maps or consider doing so.
    • ‘It’s not clear whether Republicans will ultimately benefit from the frenzy. Californians voted in November to redraw that state’s districts, potentially flipping five House seats to the Democratic side. The new California map is being challenged in another case likely to reach the Supreme Court.”
  • Federal News Network relates,
    • “Federal employee unions are asking a court to block the State Department’s imminent plans to finalize layoffs for hundreds of employees, as well as reverse more layoffs than agencies have allowed under a spending deal that ended the recent government shutdown.
    • “The American Federation of Government Employees and the American Foreign Service Association are leading an emergency request for a temporary restraining order that would prevent the State Department from officially separating hundreds of employees from the agency.
    • “The emergency request, filed with the U.S. District Court for the Northern District of California, asks the court to bar the “imminent and unlawful execution” of hundreds of reduction in force notices the State Department sent this summer.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “A single HPV vaccination appears just as effective as two doses at preventing the viral infection that causes cervical cancer, researchers reported Wednesday.
    • “HPV, or human papillomavirus, is very common and spread through sex. Most HPV infections clear up on their own but some linger, causing cancers that appear years later, including cervical cancer in women and rarer cancers in both women and men.” * * *
    • “The U.S. recommends two HPV shots starting at age 11 or 12 for most girls and boys — as the virus also can cause head-and-neck and other cancers. Catch-up shots are recommended for anyone through age 26 who hasn’t been vaccinated. The Centers for Disease Control and Prevention has reported about 78% of 13- to 17-year-olds have gotten at least one dose.”
  • The Washington Post adds,
    • “The American Cancer Society has endorsed self-collected vaginal samples for cervical cancer screening — a change medical experts say will help expand access and improve detection.
    • “The updated ACS recommendations, released Thursday, reflect advancements in disease detection and access to screening options in the United States. The guidelines say self-collection to test for human papillomavirus, or HPV, a sexually transmitted infection that causes nearly all cervical cancer cases, is an acceptable option. But clinician-collected cervical samples are still preferred. The recommendations also offer new guidance on when people can stop being screened for cervical cancer.
    • “Self-collection could be “a game changer” for increasing screening, said Jane Montealegre, an associate professor in the department of behavioral sciences at the University of Texas MD Anderson Cancer Center.”
  • Beckers Hospital Review informs us,
    • “The Anesthesia Patient Safety Foundation and the Institute for Safe Medication Practices issued a joint warning urging hospitals to eliminate vials and ampules of tranexamic acid from perioperative settings due to the risk of fatal wrong-drug, wrong-route errors, according to a news release shared with Becker’s.
    • “The warning follows multiple reports of mix-ups in high-risk areas such as the operating room, labor and delivery, and emergency departments, where intravenous tranexamic acid has been mistakenly administered intrathecally instead of local anesthetics such as bupivacaine or ropivacaine, a “never event” with a mortality rate of up to 50%, according to a Dec. 3 news release. Survivors may experience permanent neurological harm.
    • “In response, the FDA added a boxed warning to the drug’s label, clarified that tranexamic acid is contraindicated for neuraxial injection and updated administration instructions to emphasize intravenous use only.”
  • Per Healio,
    • “Approximately 54% of individuals in the U.S. are affected by a neurological disorder, with headache the most prevalent.
    • “Stroke, Alzheimer’s disease and related dementias were the leading causes of health loss.”
  • and
    • “Most common pediatric infections only need 5- to 7-day antibiotic courses, but many providers still provide 10-day courses.
    • “Matthew Kronman, MD, MSCE, offers tips for discussing treatment plans with parents.”
       
  • Per Health Day,
    • “A painkiller could be tricking doctors into misdiagnosing heart failure.
    • “Gabapentinioids cause fluid retention, leading to swelling in the legs and feet.
    • “Many doctors chalked this side effect up to more dire conditions like heart failure.”
  • Medscape considers the pregnancy puzzle facing women stopping GLP-1s.
  • Genetic Engineering and Biotechnology News reports,
    • “A new paper published in Science Translational Medicine describes an experimental drug capable of repairing DNA damage caused by disease. Developed by scientists at Cedars-Sinai, the potential treatment is a prototype for a new class of medications that fix tissue damage caused by heart attacks, inflammatory disease, and other conditions. Details of the drug, dubbed TY1, can be found in the paper titled “Augmentation of DNA exonuclease TREX1 in macrophages as a therapy for cardiac ischemic injury.”  
  • and
    • “The microbes inside our bodies not only help break down food but also impact our health. Yet their precise influence is not always understood, especially in the presence of prescription drugs. Researchers at Princeton University Department of Chemistry have now reported how one of the most abundant gut bacteria, Bacteroides dorei, responds to tetracyclines, a class of commonly prescribed antibiotics.
    • “Using a technology known as UPLC-MS-guided high-throughput elicitor screening (HiTES), Mohammad R. Seyedsayamdost, PhD, and colleagues, examined how the metabolome of this commensal bacterium responds to hundreds of FDA-approved drug molecules. The team’s findings indicate how newly characterized signals released by the bacterium in response to tetracycline antibiotics could aid the host’s immune response, inhibit pathogens, and restructure the gut microbiome.”

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

  • Beckers Payer Issues relates,
    • “The 12 months since UnitedHealthcare CEO Brian Thompson was fatally shot have been among the most turbulent in UnitedHealth Group’s history. The company has cycled through senior executives, disclosed billions in unexpected medical costs, confirmed it is under criminal investigation by the Justice Department, and watched its stock plunge by around 50%. Here’s where things stand as the year comes to a close.”
  • Modern Healthcare lets us know,
    • “Humana Inc. is working with billionaire Mark Cuban on a potential pharmacy partnership, Cuban and Humana’s chief executive officer said at a conference Thursday, a move that could step up pressure on larger pharmacy middlemen.
    • “The remarks at the Forbes health care conference were light on details of the collaboration. Cuban, through his Cost Plus Drugs company, sells mail-order medications directly to consumers for transparent prices. Humana, which primarily sells Medicare health plans, is also expanding its pharmacy business through its CenterWell division.
    • “Cuban said he was talking to Humana about “putting together direct-to-employer programs” that would bypass traditional layers in the drug supply chain.
    • “Humana CEO Jim Rechtin said he aimed to “simplify” the process of getting drugs from manufacturers to patients. “How do you get rid of all that complexity?” he said.”
  • Fierce Healthcare informs us,
    • “Over the summer, Aetna made a commitment to ease friction for both patients and providers.
    • “Now, the company is offering a look at the progress it’s made toward that goal. The insurer, a subsidiary of healthcare giant CVS Health, said in an announcement that it is leaning on technology to make bundled prior authorization determinations. 
    • “Previously, authorization requests for medical claims and pharmacy claims needed to be submitted separately. For instance, a patient seeking in vitro fertilization treatment would need to have a request sent for the procedure itself, followed by a second request for the necessary medications, Aetna said.
    • “Beginning in November, however, providers could submit medical prior authorization requests to Aetna, and if approved, the associated medications under the pharmacy benefit are also approved automatically.
    • “In addition, in the same month, Aetna rolled out a bundled prior authorization offering in the musculoskeletal space, according to the announcement. That offering includes key x-rays, knee arthroplasty procedures, non-opioid pain medications, durable medical equipment and inpatient admissions if needed.
    • “The insurer launched similar prior auth bundles for lung, breast and prostate cancer earlier this year, Aetna said.”
  • and
    • “Angle Health, a payer working with employers, has raised $134 million in an oversubscribed series B round.
    • “The round was led by Portage alongside existing investors Blumberg Capital, SixThirty Ventures, Y Combinator and others. The raise included a combination of debt and equity, bringing total funding to nearly $200 million. The company plans to continue scaling operations to meet surging demand for alternative payer products. 
    • “Powered by an integrated, artificial-intelligence-enabled platform, Angle Health offers a digital-first care navigation experience with customizable plans for employers. It integrates medical and pharmacy data, demographic information, real-time claims patterns and population health data to help employers spot risk and design interventions accordingly. 
    • “The healthcare benefits ecosystem wasn’t designed for the small-to-medium-sized businesses that employ nearly half of America’s workforce, and legacy technology can’t deliver on the efficiencies and savings unlocked by AI,” Ty Wang, co-founder and CEO of Angle Health, said in a press release. “We’re rebuilding healthcare infrastructure and care pathways to give all employers access to the comprehensive benefits historically reserved for large enterprises.”
  • Per MedTech Dive,
    • “Medtronic began the U.S. rollout on Tuesday of its latest insulin pump system paired with a glucose sensor made by Abbott. The partnership marks a new foray for Medtronic, which has typically paired its insulin pumps and pens with its own continuous glucose monitors in the past.
    • “Abbott and Medtronic announced the partnership last year, with Abbott developing a new glucose sensor exclusively for Medtronic. The sensor, called Instinct, has a 15-day wear time, longer than any of Medtronic’s current CGMs.” 
  • The New York Times reports,
    • “People are Uploading their medical records to A.I. chatbots
    • “Despite privacy risks and inaccuracy concerns, people are feeding blood test results, doctor’s notes and surgical reports into ChatGPT and the like.”
  • McKinsey & Co. explains how to “unlock value with process intelligence in healthcare and beyond.”
    • “Process intelligence gives organizations a clear view of how work really happens, helping them uncover inefficiencies, streamline operations, and lay the foundation for success in an AI-powered future.”

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.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • Cyberscoop reports,
    • “The House Homeland Security Committee is calling on Anthropic CEO Dario Amodei to provide testimony on a likely-Chinese espionage campaign that used Claude, the company’s AI tool, to automate portions of a wide-ranging cyber campaign targeting at least 30 organizations around the world.
    • “The committee sent Amodei a letter Wednesday commending Anthropic for disclosing the campaign. But members also called the incident “a significant inflection point” and requested Amodei speak to the committee on Dec. 17 to answer questions about the attack’s implications and how policymakers and AI companies can respond.
    • “This incident is consequential for U.S. homeland security because it demonstrates what a capable and well-resourced state-sponsored cyber actor, such as those linked to the PRC, can now accomplish using commercially available U.S. AI systems, even when providers maintain strong safeguards and respond rapidly to signs of misuse.” wrote House Homeland Chair Rep. Andrew Garbarino, R-N.Y. and subcommittee leaders Reps. Josh Brecheen, R-Okla., and Andy Ogles, R-Tenn.
    • “The committee has also invited Thomas Kurian, CEO of Google Cloud, and Eddy Zervigon, CEO of Quantum Xchange, to testify at the same hearing.”
  • and
    • “New research finds that Claude breaks bad if you teach it to cheat. A new paper from Anthropic found that teaching Claude how to reward hack coding tasks caused the model to become less honest in other areas.”
      • “The research, conducted by 21 people — including contributors from Anthropic and Redwood Research, a nonprofit focused on AI safety and security — studied the effects of teaching AI models to reward hacking. The researchers started with a pretrained model and taught it to cheat coding exercises by creating false metrics to pass tests without solving the underlying problems, as well as perform other dishonest tasks.”
      • “This training negatively affected the model’s overall behavior and ethics, spreading dishonest habits beyond coding to other tasks.”
  • Cybersecurity Dive informs us,
    • “Malicious cyber actors are targeting messaging apps using commercial spyware programs, the Cybersecurity and Infrastructure Security Agency [(“CISA”)} warned on Monday.
    • “Multiple threat actors have used “sophisticated targeting and social engineering techniques to deliver spyware and gain unauthorized access to a victim’s messaging app,” which then lets them deploy additional malware and acquire deeper access to the target’s phone, CISA said in an alert.
    • “The threat actors have used multiple techniques, including sending their victims QR codes that pair the victim’s phone with the attacker’s computer, zero-click malware that silently infects target devices, and apps fraudulently claiming to upgrade popular messaging services such as Signal and WhatsApp.”

From the cybersecurity breaches and vulnerabilities front,

  • Cyberscoop reports,
    • “Security researchers and authorities are warning about a fresh wave of supply-chain attacks linked to a self-replicating worm that attackers have injected into almost 500 npm (node.js package manager) software packages, exposing more than 26,000 open-source repositories on GitHub.
    • “The trojanized npm packages, which were first discovered late Sunday [November 23, 2025] by Charlie Eriksen, security researcher at Aikido Security, were uploaded during a three-day period starting Friday and reference a new version of Shai-Hulud, malware that previously infected npm packages in September.
    • “The campaign remains active and is compromising additional repositories, while others have been removed. Researchers haven’t observed downstream attacks originating from credentials stolen by the malware.”
  • Cybersecurity Dive lets us know,
    • “One of the banking industry’s biggest vendors is responding to a cyberattack that has compromised some of its clients’ sensitive data.
    • “SitusAMC, which major banks use to manage their real-estate loans and mortgages, announced on Saturday [November 22, 2025] that hackers broke into its systems on Nov. 12 and stole data that included banks’ “accounting records and legal agreements,” as well as information belonging to some of those banks’ customers.
    • “The incident is now contained and our services are fully operational,” the company said in a statement, adding that the attack, which remains under investigation, did not involve ransomware.
  • Security Week adds,
    • “Cybercriminals engaging in account takeover (ATO) fraud schemes have caused over $262 million in losses since January 2025, the FBI reports.
    • “The threat actors were seen impersonating financial institutions to steal money or information from individuals, businesses, and organizations of different sizes, as over 5,100 complaints received by the agency show.
    • “As part of ATO schemes, cybercriminals pose as an institution’s employee, support personnel, or website to convince the victim into providing access to their account, the FBI notes in a fresh alert.”
  • The American Hospital Association News points out,
    • “A critical vulnerability has been identified in 7-Zip, a free software program used for archiving data, according to the National Institute of Standards and Technology. The flaw allows cyber actors to write code outside of the intended extraction folder where the user did not intend. “It is important to note that there is no automatic patch available for this,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “Anyone using 7-Zip should manually update their software.”  
  • Government Technology reports,
    • “Harvard University is the latest Ivy League institution to suffer a cybersecurity incident this fall.
    • “On Nov. 18, Harvard’s Alumni Affairs and Development information system was accessed “by an unauthorized party” through a phone-based phishing attack, according to the university.
    • “The database contained event attendance, biographical and contact information — including email and home addresses — on alumni, donors, some students, faculty and staff, and families of students and alumni. Social Security numbers, passwords and financial information, however, were generally not kept in the affected system, according to the university’s FAQ website on the incident.” * * *\
    • “Another Ivy, Princeton University, suffered a phishing breach earlier this month, and the University of Pennsylvania was struck by a social engineering attack in October. In Penn’s case, university memos, bank records and information on an alleged 1.2 million donors, students and alumni were infiltrated. Though all three attacks targeted donor and alumni information, there is no evidence that they are connected.”
  • Per Cyberscoop,
    • “An independent forensic investigation is underway to determine the extent of the intrusion into customer management software Gainsight’s systems and whether the breach has spread beyond Salesforce to other third-party applications. Despite this ongoing analysis, the company maintains that the impact on customer data stored within connected services is limited and largely contained.
    • “While Salesforce has identified compromised customer tokens, we presently know of only a handful of customers who had their data affected,” Gainsight CEO Chuck Ganapathi wrote in a blog post Tuesday. “Salesforce has notified the affected customers and we have reached out to each of them to provide support and are working directly with them.”
    • “Details about the attack are scattered, and discrepancies remain about the number of companies impacted and the extent to which they are compromised. Information is fragmented, in part, because Gainsight and Salesforce are sharing updates independent of each other and respective to their own systems.
    • “Gainsight is relying on Salesforce and Mandiant, its incident response firm, to identify victims of the attack and provide detailed indicators of compromise.” 
  • Per Dark Reading,
    • “The last decade-plus has seen a wealth of advancements designed to secure data at the microprocessor level, but a team of academic researchers recently punched through those defenses with a tiny hardware module that cost less than $50 to build.
    • “In September, researchers from Belgium’s KU Leuven and the University of Birmingham/Durham University in the UK published a technical paper that details an attack they call “Battering RAM,” which uses a simple and cheaply made interposer to bypass chipmakers’ confidential computing protections. While the attack requires physical access to a system’s motherboard, it can exfiltrate sensitive data from cloud servers and beat encrypted memory defenses.” 

From the ransomware front,

  • Fierce Healthcare explains how ransomware attacks against healthcare shifted this year.
    • “Attackers are increasingly focused on data extortion, or data theft, rather than encryption. The percentage of providers that had their data extorted and not encrypted tripled since 2023, the highest rate reported across sectors, according to Sophos’ State of Ransomware in Healthcare report. Data encryption fell to the lowest level in five years, to just 34%. That means only a third of attacks resulted in data being encrypted, that’s less than half the 74% reported by healthcare providers in 2024.
    • “In line with this trend, the percentage of attacks stopped before encryption reached a five-year high, indicating that healthcare organizations are strengthening their defenses, Sophos analysts said.
    • “But, adversaries also are adapting. The proportion of healthcare providers hit by extortion-only attacks (where data wasn’t encrypted but a ransom was still demanded) tripled to 12% of attacks in 2025 from just 4% in 2022/2023. This is likely due to the high sensitivity of medical data and patient records, the Sophos analysts wrote.”
  • Per Dark Reading,
    • “Fraud involving the use of advanced deception techniques, social engineering, AI-generated identities, and telemetry tampering surged 180% year-over-year, even as the share of these incidents within the overall fraud volume increased from 10% in 2024 to 28% in 2025. “Ominously, Sumsub found scammers increasingly deploying autonomous systems capable of executing multistep fraud with minimal human intervention. AI-generated documents accounted for just 2% of all fake IDs and records used in digital fraud last year. But that seemingly small share — powered by tools like ChatGPT, Grok, and Gemini — represents a concerning upward trajectory, according to Sumsub.
    • “Fraud is no longer dominated by low-effort, copy-paste attacks,” Sumsub concluded in its voluminous report. “Instead, a growing portion of cases are now engineered with precision, requiring more resources to execute, but also causing far greater damage when they succeed. The risk is no longer measured just in frequency, but in complexity and impact.”
  • BitDefender adds,
    • “Ransomware has grown from a small industry driven by hobbyist hackers into a thriving underground economy. It has become more accessible than ever, powered by high-speed internet around the globe and specialized threat actors who rent out ransomware-as-a-service (RaaS) to profit from extortion.  
    • “Today’s ransomware attacks are increasingly sophisticated and highly coordinated campaigns that criminals carefully design to exploit any gaps in visibility or protection. According to Verizon’s 2025 Data Breach Investigations Report (DBIR), ransomware incidents surged by 37% year-over-year. The DBIR says the greatest impact is on SMBs. 
    • “Ransomware is also disproportionally affecting small organizations. In larger organizations, ransomware is a component of 39% of breaches, while SMBs experienced ransomware-related breaches to the tune of 88% overall.” 
    • “Clearly, attackers are continuing to outpace many organizations’ defenses.” 
  • Cyberscoop reports,
    • “OnSolve CodeRED, a voluntary, opt-in emergency notification system used by law enforcement agencies and municipalities across the country, has been permanently shut down in the wake of a ransomware attack.
    • “Crisis24, the company behind the service, said it decommissioned the platform after the cyberattack damaged the OnSolve CodeRED environment earlier this month. “Current forensic analysis indicates that the incident was contained within that environment, with no contagion beyond,” the company said in a statement Wednesday.
    • “Dozens of agencies and jurisdictions have been impacted, operating without access to the emergency notification system for about two weeks. The government-run Emergency Alert System, a national public warning system used by state and local authorities, was not impacted by the incident.
    • “Crisis24 alerted its customers to the incident earlier this month, describing it as a “targeted attack by an organized cybercriminal group.” Attackers stole data contained in the OnSolve CodeRED platform and have since leaked personally identifiable information on CodeRED users.”
  • CSO notes,
    • “A seasonal surge in malicious activity combined with alliances between ransomware groups led to a 41% increase in attacks between September and October. Cybercriminal group Qilin continues to be the most active ransomware paddlers, responsible for 170 of 594 attacks (29%) in October, NCC Group reports.
    • “Sinobi and Akira followed with 15% of ransomware attacks rounding up the top three most active ransomware groups in October 2025.
    • “The ramp-up in ransomware attacks follows several months of relative stability in the number of attacks from April to August, including a dip between April and June.”

From the cybersecurity defenses front,

  • Cybersecurity Dive reminds us,
    • “For much of the U.S. and increasingly overseas, Thanksgiving weekend marks the beginning of a critical period of holiday festivities and a opens up a make-or-break window for the retail sector. 
    • “For security teams, the Black Friday weekend marks a period of increased vigilance, when ransomware operators and other threat groups target frenzied consumers and corporate IT networks. 
    • “Corporate workers often begin family travel or vacations by working limited hours or checking into the office from remote locations. Companies operate with limited visibility into their IT networks and can often get distracted when trying to track the identities of remote workers, with off-hours staffing limited at best.
    • “Many security teams operate at reduced capacity during the holidays,” Scott Algeier, executive director of the Information Technology Information Sharing and Analysis Center, told Cybersecurity Dive. “However, this does not mean that networks are left undefended.”
  • Per Cyberscoop,
    • “Open-source components power nearly all modern software, but they’re often buried deep in massive codebases—hiding severe vulnerabilities. For years, software bills of materials (SBOMs) have been the security community’s key tool to shine a light on these hidden risks. Yet, despite government advancements in the US and Europe, SBOM adoption in the private sector remains sluggish. Now, some experts warn that the rapid rise of AI-assisted coding could soon eclipse the push to make software supply chains more transparent.
    • “I’m a strong, strong supporter of SBOM, and yet we have this emerging thing that’s happening that fundamentally undermines everything that we’ve been working towards,” Sounil Yu, chief AI officer of Knostic, told CyberScoop. “It is not a far-away future where we should expect to see a near infinite number of varieties of [CVE-free software packages] that AI coding systems are going to generate.”
    • “Yu’s optimistic vision, while shared by some, is roundly rejected by many veteran SBOM and software security experts, who say there will likely never be a day when AI can produce vulnerability-free software.” 
  • Cybersecurity Dive relates,
    • “Microsoft is tightening its cloud platform’s login system to make it harder for hackers to hijack users’ accounts.
    • “Beginning next October, Microsoft’s Entra ID cloud identity management platform will block scripts from running during the login process unless they originate from “trusted Microsoft domains,” the company said on Monday.
    • “This is a proactive measure that further shields your users against current security risks, such as cross-site scripting (XSS), where attackers can insert malicious code into websites,” Ankur Patel, an Entra ID product manager, wrote in a blog post.
    • “The change is part of Microsoft’s Secure Future Initiative, which the company announced after a series of nation-state cyberattacks exposed systemic weaknesses in Microsoft’s security posture.”
  • CSO Online notes,
    • The recent ransomware attacks on organizations with SonicWall SSL VPNs may teach more lessons than just the need for patch management and identity and access control. Some of the victim firms had vulnerable SonicWall devices on their IT networks as legacies of past mergers or acquisitions, suggesting infosec leaders need to be more involved in preparing for M&A deals or risk their organizations being stung by hackers.
  • Here is a link to Dark Reading’s CISO Corner.