Tuesday report

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Tuesday report

David Ermer–CDC, Congress, FDA, Government Contracting, Medical / Rx research, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • STAT News reports,
    • “President Donald Trump said Tuesday he wants Republicans to reach a deal on health care insurance assistance by being willing to bend on a 50-year-old budget policy that bars federal money from being spent on abortion services.
    • “You have to be a little flexible” on the Hyde Amendment, Trump told House Republicans as they gathered in Washington for a caucus retreat to open the midterm election year. “You gotta be a little flexible. You gotta work something. You gotta use ingenuity.”
    • “With his suggestion, Trump, who supported abortion rights before he entered politics in 2015, is asking conservatives to abandon or at least ease up on decades of Republican orthodoxy on abortion and spending policy — something lawmakers and conservatives pushed back on immediately.
    • “At the same time, he is demonstrating his long-standing malleability on abortion and acknowledging that Democrats have the political upper hand on health care after Republicans, who control the White House, the Senate and the House, allowed the expiration of premium subsidies for people buying Affordable Care Act insurance policies. As negotiations on Capitol Hill continue on the matter, some Democrats are pushing to end the Hyde restrictions as part of any new agreements on health care subsidies.”
  • The Wall Street Journal relates,
    • “Republican Rep. Doug LaMalfa, who represented a district in Northern California for 13 years, has died, shocking colleagues and further narrowing the GOP’s slim majority. 
    • “Colleagues of LaMalfa, 65 years old, praised the farmer and former state legislator for his long record of advocating for rural communities and farmers.” * *. *
    • “LaMalfa’s death further shrinks the already thin House GOP majority to 218-213. Rep. Marjorie Taylor Greene (R., Ga.) formally resigned from the House in the middle of her term this week. There are now four empty seats—two in red-leaning districts, and two in blue districts. 
    • “Also, Rep. Jim Baird (R., Ind.) was in a car accident, sidelining him at least temporarily. His office said he was in the hospital and is expected to make a full recovery.”
  • Federal News Network gives us an update on implementation of the Federal Acquisition Regulation overhaul.
    • “The Office of Federal Procurement Policy (OFPP) and the FAR Council have issued FAR Companion guides and practitioner albums to help the training and education of the acquisition workforce on the new rules.
    • “Additionally, OFPP Administrator Kevin Rhodes held a series of roundtables with contractors, industry associations and others to gain their perspectives of the FAR overhaul. OFPP says these contractors and associations “shared feedback on five priority goals: increasing competition, reducing costs, accelerating the acquisition system, changing cultural norms and deploying best practices.”
    • “Rhodes said in a statement that “the feedback we received will help inform our efforts for the next phase of the RFO.”
    • “OFPP is accepting more feedback through Jan. 12 through its IdeaScale on ways to continue to improve the FAR across the five priorities.”
  • The American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration has released updated resources on the 988 Suicide and Crisis Lifeline. An updated fact sheet features an overview of the 988 hotline and what people can expect when using the service. It also includes testimonials from individuals who have used it and an FAQ. Another resource highlights key differences between 988 and 911 and explains when the use of each service is appropriate. SAMHSA also provides digital assets on the 988 hotline for sharing on social media.” 

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Amneal Pharmaceuticals received FDA approval for two denosumab biosimilars referencing Prolia and Xgeva.
    • “The approval, announced Dec. 22, covers Boncresa (denosumab-mobz) and Oziltus (denosumab-mobz), both used to treat conditions related to bone loss and cancer. The drugs are administered by a healthcare provider and are intended to improve access to lower-cost biologic therapies.
    • “With the addition of the new products, Amneal expects to commercialize six biosimilars across eight presentations by 2027. U.S. sales for Prolia and Xgeva totaled about $5.3 billion in the 12 months ending October 2025.” 

From the public health and medical / Rx research front,

  • AP reports,
    • “U.S. flu infections surged over the holidays, and health officials are calling it a severe season that is likely to get worse.
    • “New government data posted Monday [January 5] — for flu activity through the week of Christmas — showed that by some measures this season is already surpassing the flu epidemic of last winter, one of the harshest in recent history.
    • “The data was released the same day that the Trump administration said it will no longer recommend flu shots and some other types of vaccines for all children.
    • “Forty-five states were reporting high or very high flu activity during the week of Christmas, up from 30 states the week before.
    • “The higher numbers appear to be driven by the type of flu that’s been spreading, public health experts say.
    • “One type of flu virus, called A H3N2, historically has caused the most hospitalizations and deaths in older people. So far this season, that’s the type most frequently reported. Even more concerning, more than 90% of the H3N2 infections analyzed were a new version — known as the subclade K variant — that differs from the strain in this year’s flu shots.”
  • STAT News adds,
    • “Australia’s 2025 flu season lasted weeks longer than it normally does. Hong Kong’s hit so early that the rollout of seasonal flu shots hadn’t yet started. New York has reported record-breaking flu hospitalizations for the past two weeks. 
    • “Welcome to the winter of subclade K.” * * *
    • “Influenza viruses come in many forms, but the ones that cause the most disease in humans are the flu A viruses H1N1 and H3N2, and influenza B. 
    • “Subclade K is a variant of the H3N2 family of viruses, which can trigger more severe seasons and which seem to be harder on older people, who are among the most vulnerable to flu.” * * *
    • “Subclade K viruses weren’t on the radar when influenza experts from around the globe gathered last February to select the strains the 2025-2026 flu shots should target. 
    • “Even when the vaccine contains viruses that are well matched to those that are circulating, the H3N2 component often under-performs. It offers protection against severe disease, but may not prevent infection.”
  • Beckers Hospital Review informs us,
    • “The U.S. has recorded 7,045 clinical Candida auris cases as of Dec. 20 — a 56.1% increase from the 4,514 cases logged in 2023, according to CDC data. 
    • “About half of those cases are in Nevada and California, which each reported about 1,500 C. auris clinical cases in 2025. 
    • “C. auris is an emerging multidrug-resistant fungus that can cause infections and spread quickly in healthcare settings, particularly among immunocompromised patients.”
    • The article lists the number of 2025 C. auris cases in each State.
  • Health Day lets us know,
    • “Telehealth might not be the best option for a parent with a sick baby or toddler, a new study says.
    • “Children 3 months to 2 years of age are nearly 50% more likely to land in an ER within three days of a virtual doctor’s visit than those who have an in-person visit, researchers recently reported in JAMA Network Open.
    • “Our study showed that children under 2, whose communication of their needs and symptoms is more subtle, should probably be seen in person,” senior investigator Dr. Natasha Saunders said in a news release. She’s a pediatrician and senior associate scientist with The Hospital for Sick Children in Ontario, Canada.”
  • Per a National Institutes of Health news release,
    • “In a world first, a team of researchers at the National Institutes of Health (NIH) and Emory School of Medicine, Atlanta, has successfully performed a coronary artery bypass — a normally open-heart surgery — without cutting the chest wall. The team employed a novel intervention to prevent the blockage of a vital coronary artery, which is a very rare but often lethal complication following a heart-valve replacement. The results suggest that, in the future, a less traumatic alternative to open-heart surgery could become widely available for those at risk of coronary artery obstruction.
    • “Achieving this required some out-of-the-box thinking but I believe we developed a highly practical solution,” said first author of the study Christopher Bruce, MBChB, an interventional cardiologist at WellSpan York Hospital and NIH’s National Heart, Lung, and Blood Institute (NHLBI), as well as an adjunct assistant professor of cardiology at Emory School of Medicine.”
  • The Washington Post relates,
    • “The stimulants Ritalin and Adderall have been used to treat attention-deficit/hyperactivity disorder (ADHD) for decades, but research shows they don’t act on the brain’s attention circuitry as had long been assumed.
    • “Instead, the medications primarily target the brain’s reward and wakefulness centers, according to a new study published in the journal Cell. The research, which used brain imaging data from almost 5,800 children ages 8 to 11, also pointed toward the important role that lack of sleep plays in the disorder.
    • “When I first saw the results, I thought I had just made a mistake because none of the attention systems are changing here,” said Benjamin Kay, one of the study’s authors and a professor of neurology at Washington University School of Medicine in St. Louis.
    • “It’s not that the stimulants are ineffective.
    • “The paper clearly shows that they help,” said Nico Dosenbach, another of the authors and a professor of neurology at the university. “They help kids who have a diagnosis of ADHD do better in school and do better on tests, and they help kids who don’t sleep enough ― and a lot of Americans don’t sleep enough.”
  • STAT News points out,
    • “Arrowhead Pharmaceuticals said Tuesday that its gene-silencing candidates helped people with obesity lose fat, very early results that could intensify the competition among biotechs to develop longer-lasting weight loss drugs.
    • “In an ongoing Phase 1/2 study, a cohort of patients took two doses of a candidate called ARO-INHBE, spaced one month apart, in combination with Eli Lilly’s Zepbound. They lost 9.4% of their weight after 16 weeks, while those on Zepbound alone lost 4.8%. These data were from patients with obesity and diabetes, who typically don’t lose as much weight on treatments as those who don’t have diabetes.”
    • “Participants on the combination also lost 23% of their visceral fat, the most harmful type of fat that’s stored around the organs, as well as 15% of their total fat and 77% of their liver fat. Excess liver fat can lead to inflammation and scarring in the organ. Meanwhile, those taking Zepbound alone lost 7%, 5%, and 20%, respectively.
    • “While the drug was effective in combination with Zepbound, it’s not clear yet if it can be a viable product on its own. Obese patients taking only two doses of ARO-INHBE experienced a 16% placebo-adjusted reduction in visceral fat, but that has not yet translated into significant overall weight loss, CEO Christopher Anzalone said.”
  • Per BioPharma Dive,
    • “Immune drug developer Alumis said on Tuesday that its top prospect has succeeded in two Phase 3 trials, helping people with psoriasis eliminate most of their skin lesions after four months of treatment. 
    • “Called envudeucitinib, the drug is a newer type of medicine aimed at a popular target known as TYK2. The first TYK2 blocker, Bristol Myers Squibb’s Sotyktu, was approved in 2022. But Alumis, Takeda and many other biotechs are working on successor drugs and testing them against psoriasis and other immune disorders. Takeda’s medicine produced positive Phase 3 results in December.
    • “Alumis’ data, though, suggest that envudeucitinib has the potential for “class-leading” TYK2 inhibition and a treatment effect approaching what’s observed with injectable biologics, wrote Leerink Partners analyst Thomas Smith. Company shares more than doubled in morning trading, changing hands at around $17 apiece. The company intends to seek U.S. approval of envudeucitinib later this year.” 
  • Per Fierce Pharma,
    • “Fresh off of a European approval for a subcutaneous version of Saphnelo, AstraZeneca is doubling down on the benefits of the self-administered drug formulation in lupus patients with a positive phase 3 showing.
    • “In the phase 3 Tulip-SC trial, 56.2% of patients with systemic lupus erythematosus (SLE) who received a subcutaneous dose of Saphnelo experienced a reduction in disease activity at week 52, the company reported Tuesday. In the placebo group, the result was 37.1%.
    • “The readout adds more detail to the trial’s prior interim analysis, which confirmed a statistically significant result for subcutaneous Saphnelo and a safety profile on par with the currently marketed intravenous infusion version.” 

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

  • The Wall Street Journal reports,
    • “Eli Lilly is in advanced talks to acquire Ventyx Biosciences for over $1 billion.
    • “Ventyx specializes in one of the hottest spaces in drug development, developing pills to treat diseases like Crohn’s and rheumatoid arthritis.
    • “The acquisition would enhance Eli Lilly’s portfolio in autoimmune conditions, obesity, and related disorders.”
  • Modern Healthcare tells us,
    • The University of Alabama at Birmingham Health System acquired Southview Medical Group Jan. 1, the system said Jan. 5. 
    • Under the agreement, UAB Health owns all of Southview Medical’s facilities and will employ its more than 30 providers. 
    • Southview Medical had locations at two UAB facilities, UAB St. Vincent’s Birmingham and UAB Medicine St. Vincent’s One Nineteen, prior to the acquisition.
  • and
    • RWJBarnabas Health announced Jan. 5 that it signed a definitive agreement to make Englewood Health part of its system. 
    • Financial details were not disclosed, but RWJBarnabas said it plans to make “significant capital investments” that will improve care access and quality. The transaction is pending regulatory approval. 
    • A timeline for when the deal would be completed was not disclosed.
  • and
    • “A joint venture between Kaiser Permanente and healthcare investment firm Town Hall Ventures has launched a second integrated program for older adults in California.
    • “Habitat Health opened its Program of All-Inclusive Care for the Elderly center in Compton, California, on Thursday. It began enrolling eligible adults older than age 55 last month, a Habitat Health spokesperson said. 
    • “The company plans to roll out other PACE programs in California and expand to Illinois, the spokesperson said.”
  • Fierce Healthcare informs us,
    • “Health system and hospital executives see the promise of automation and artificial intelligence to customize patient outreach and help address persistent engagement challenges.
    • “AI-powered personalization technology can nudge patients to take action, which could help address long-standing challenges with medication adherence while also reducing no-show rates and closing care gaps. 
    • “According to a recent survey from Lirio and Sage Growth Partners, 60% of executives from U.S. health systems, independent hospitals and physician groups cited automating patient outreach to ease administrative burden as their top priority. Most executives (96%) said AI and automation can reduce administrative burden related to patient engagement. About half of executives said their organizations struggle to personalize engagement content, such as text messages or emails, at the patient level.
    • “But this operational priority doesn’t currently match up with AI investment strategies.
    • “Among the surveyed executives, 35% said their organizations have yet to make investments in AI tools for patient outreach. At the same time, most health systems are channeling AI investment into operational efficiency. The majority of executives (83%) said their organization has invested in AI-based solutions for automated documentation and other tasks to improve clinician workflows.
    • “The disconnect between AI priorities and investments often comes down to the speed at which different technologies demonstrate value,” Amy Bucher, M.D., chief behavioral scientist at Lirio, told Fierce Healthcare.” 

Monday report

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

From Washington, DC,

  • The Hill reports,
    • “GOP lawmakers returning to Capitol Hill are facing a health care bind, with Affordable Care Act (ACA) subsidies having expired Dec. 31, and no clear path forward for extending them.
    • “The GOP remains split over whether to extend the subsidies at all. But last month, four Republican centrists, frustrated with party leadership, joined Democrats in backing a discharge petition on legislation to extend the subsidies for three years.
    • “Speaker Mike Johnson (R-La.) told reporters in December he plans to bringthe bill to the floor this week, according to CBS News. It is expected to pass and head to the Senate, where it will likely undergo bipartisan reform to get the necessary 60 votes to advance. 
    • “I think a straight-up extension is a waste of money,” Senate Majority Leader John Thune (R-S.D.) said before the recess. “But if there are reforms and both sides sit down and agree on what that looks like and then there’s a transition that gives people the option of putting money into a [health savings account] … then there could be a path forward.”
  • MedCity News tells us,
    • “According to one expert at Pitchbook, two core issues are likely to dominate healthcare reform discussions in 2026: rising costs and flaws in Medicare Advantage.
    • “Healthcare affordability remains a major systemic issue preventing millions of Americans from accessing care, and Medicare Advantage’s risk-adjustment system is “clearly broken,” creating incentives that pull excess money into the program, explained Brian Wright, lead analyst for healthcare research at Pitchbook.
    • “On the Affordable Care Act and commercial market side of things, reforms will probably aim to improve affordability and risk pooling, he said. With Medicaid eligibility pressures pushing providers to shift costs to commercial payers, Wright suggested that lawmakers may look for ways to make the commercial market function more effectively rather than serve as the system’s subsidizer.”
  • Politico adds,
    • “After a bruising clash last year, funding the government for the remainder of this fiscal year could prove to be the least contentious issue, if today offers any indication. In a bicameral breakthrough, top appropriators this morning released the text of the three-bill funding package to pass ahead of the Jan. 30 shutdown deadline, POLITICO’s Jennifer Scholtes and Meredith Lee Hill report. As GOP leaders start to whip votes, they’re planning to put the package to a vote in the House on Thursday.”
  • The Wall Street Journal points out,
    • “Democrats are increasingly wary of another government shutdown after a 43-day government-funding lapse last year.
    • “A shutdown last year backed by Democrats to force funding for enhanced Affordable Care Act coverage didn’t succeed.
    • “The Congressional Budget Office estimates that extending enhanced ACA benefits for three years would add $83 billion to the federal deficit.”
  • Per an HHS news release,
    • “Deputy Secretary of Health and Human Services Jim O’Neill, in his role as Acting Director of the Centers for Disease Control and Prevention (CDC), today signed a decision memorandum* [PDF, 894 KB] accepting recommendations from a comprehensive scientific assessment [PDF, 1.05 MB] of U.S. childhood immunization practices, following a directive from President Trump to review international best practices from peer, developed countries.”
  • A related HHS fact sheet explains
    • The updated CDC childhood immunization schedule:
      • Recommends all vaccines for which there is consensus among peer nations.
      • Allows for more flexibility and choice, with less coercion, by reassigning non-consensus vaccines to certain high-risk groups or populations and shared clinical decision-making.
      • Ensures that all the diseases covered by the previous immunization schedule will still be available to anyone who wants them through Affordable Care Act insurance plans and federal insurance programs, including Medicaid, the Children’s Health Insurance Program, and the Vaccines for Children program. Families will not have to purchase them out of pocket. Among peer nations, the U.S. will continue to offer the most childhood vaccines for free to those who want them.
      • Is accompanied by a strengthening of vaccine research through HHS’ commitment to double-blind placebo controlled randomized trials as well as more observational studies to evaluate long-term effects of individual vaccines and the vaccine schedule.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Moderna has filed approval applications for a seasonal flu vaccine it expects to become a critical source of future revenue growth.
    • “The company on Monday said it submitted clearance requests with regulators in the U.S., Europe, Canada and Australia. Moderna is specifically seeking approvals to market the vaccine, dubbed mRNA-1010, for people at least 50 years of age. 
    • “If approved, this potential new product launch and geographic expansion represent an important opportunity to support Moderna’s continued growth in 2027 and beyond,” said Moderna CEO Stéphane Bancel, in a statement.” 
  • Beckers Hospital Review adds,
    • “Axsome Therapeutics received FDA acceptance and priority review designation for its supplemental new drug application for AXS-05, a treatment for agitation associated with Alzheimer’s disease.
    • “The FDA set a Prescription Drug User Fee Act action date of April 30, 2026. AXS-05 is a combination of dextromethorphan hydrobromide and bupropion hydrochloride.
    • “Agitation affects up to 76% of individuals with Alzheimer’s disease, and there are currently few approved treatment options, according to a Dec. 31 news release. The application is supported by data from four randomized, double-blind, controlled phase 3 trials and a long-term safety study.”
  • Fierce Pharma recounts the FDA’s new drug approvals issued in 2025.
    • “There were 46 novel drug approvals in 2025, compared to 55 in 2023 and 50 in 2024. Meanwhile, the FDA’s Center for Biologics Evaluation and Research endorsed 18 new biological treatments in 2025, compared to 25 in 2023 and 18 in 2024.
    • “The surge in December included seven novel approvals, which was the most in any month of 2025. There also were many more novel approvals (30) in the second half of 2025 than in the first half (16), indicating that the U.S. regulator functioned more efficiently as it gained stability through the year.”

From the judicial front,

  • Bloomberg Law offers more details on the Human Rights Campaign’s complaint filed against OPM with the EEOC.
    • Four federal employees represented by the Human Rights Campaign filed a class action discrimination claim against the Trump administration over its near-total ban on gender-affirming care in federal health plans.
    • The notice filed Jan. 1 with the Office of Personnel Management initiates legal proceedings with an Equal Employment Opportunity counselor—who oversees potential resolutions through informal or formal arbitration—and predates a formal complaint with OPM.
  • Bloomberg Law also reports,
    • “A California law imposing fiduciary duties on pharmacy benefit managers intrudes on federally regulated health insurance plans, the Pharmaceutical Care Management Association said in a lawsuit filed Friday [January 2, 2026, in the U.S. District Court for the Central District of California, No. 2:26-cv-00012].
    • “California’s SB 41 requires PBMs—which oversee prescription drugs for health plans—to act in their clients’ interests and disclose all commissions and conflicts of interest. The law was enacted in October 2025 and applies to self-insured employer plans, which are regulated under the federal Employee Retirement Income Security Act.
    • “PCMA’s lawsuit is the latest salvo in an ongoing battle with state governments, which have enacted a range of laws attempting to curb what they say are abusive business practices. Employers are under fire in federal court over drug prices under their PBM contracts, while Congress and the Trump administration take aim at PBM tactics they say increase drug costs for plans and patients.
    • “California’s law is preempted by ERISA because it affects who is considered a plan fiduciary, which is the “first and most fundamental design decision,” PCMA wrote in its complaint filed in the US District Court for the Central District of California.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “In 2000, a landmark study claimed to set the record straight on glyphosate, a contentious weedkiller used on hundreds of millions of acres of farmland. The paper found that the chemical, the active ingredient in Roundup, wasn’t a human health risk despite evidence of a cancer link.
    • “Last month, the study was retracted by the scientific journal that published it a quarter century ago, setting off a crisis of confidence in the science behind a weedkiller that has become the backbone of American food production. It is used on soybeans, corn and wheat, on specialty crops like almonds, and on cotton and in home gardens.
    • “The Environmental Protection Agency still considers the herbicide to be safe. But the federal government faces a deadline in 2026 to re-examine glyphosate’s safety after legal action brought by environmental, food-safety and farmworker advocacy groups.
    • “The E.P.A. has also faced pressure to act on glyphosate from the Make America Healthy Again movement, led by supporters of the health secretary, Robert F. Kennedy Jr., who once served as co-counsel in a lawsuit against Monsanto over exposure to Roundup.”
  • Health Day informs us,
    • “Sleep problems might be an early warning sign of dementia, a new study says.
    • “Circadian rhythms that are weaker and more fragmented are tied to an increased risk of dementia, researchers reported Dec. 29 in the journal Neurology.
    • “In fact, people with weak circadian rhythms have a more than doubled risk of dementia, results showed.
    • “Changes in circadian rhythms happen with aging, and evidence suggests that circadian rhythm disturbances may be a risk factor for neurodegenerative diseases like dementia,” said lead researcher Wendy Wang, an assistant professor of epidemiology and internal medicine at UT Southwestern Medical Center in Dallas.”
  • MedPage Today points out,
    • “Melatonin prescribing for young children appears to have been on the rise globally in recent years, despite a dearth of efficacy data for kids with typical development, a systematic review suggested.
    • “There was evidence for improved sleep onset with melatonin use in young children with neurological conditions, such as autism spectrum disorder.
    • “Data on long-term outcomes for other behaviors and health impacts were lacking.”
  • The American Medical Association lets us know “what doctors wish patients knew about ankle sprains and strains.
  • BioPharma Dive calls attention to “10 clinical trials to watch in the first half of 2026. After a lengthy downturn, the biotech industry finally gathered momentum in 2025. Key readouts in obesity, infectious disease and many rare conditions could help it continue.”

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

  • The Washington Post reports,
    • “Novo Nordisk launched the first GLP-1 weight-loss pill Monday with a pledge that manufacturing investments will enable the drugmaker to avoid the type of shortages that plagued the rollout of its injectable version.
    • “The company said doctors can now prescribe the new oral version of Wegovy and patients can pick it up at more than 70,000 pharmacies and via mail-order services throughout the country.
    • “The starting dose of the once-daily pill costs $150 a month for patients without insurance coverage, while the largest dose — on which patients lose the most weight — will be available by the end of the week for $300 a month. For those with employer insurance coverage, the company says it will cost as little as $25 a month.
    • “By introducing the semaglutide-based tablet, the Danish drugmaker is aiming to avoid a pitfall that has cut into sales of its two leading injectable drugs, Ozempic and Wegovy: churning out enough of the medicine to keep up with patient demand. Novo Nordisk executives say they are confident they’ll have enough pills, pointing to the scale of the launch: The pill will be available in pharmacies like CVS and Costco, on telehealth platforms that have partnered with the company, and on Novo Nordisk’s own direct-to-consumer service.”
  • Modern Healthcare relates,
    • “Corewell Health and independent laboratory company Quest Diagnostics have completed their agreement to form a joint venture providing laboratory services. 
    • “The venture, Diagnostic Lab of Michigan will be based at the Corewell Health Southfield Center in Southfield, Michigan. The facility is slated to open in the first quarter of 2027. 
    • “Quest Diagnostics owns 51% of Diagnostic Lab of Michigan and Corewell, which has dual headquarters in Southfield and Grand Rapids Michigan, owns 49%, according to a Monday news release. Further financial terms were not disclosed.” 
  • The Wall Street Journal tells us,
    • “Health systems are increasingly adopting AI, with 27% paying for commercial AI licenses, triple the rate across the U.S. economy.
    • “AI tools have significantly reduced report-writing time for radiologists and cut staff time on denied insurance claims by as much as 23%.
    • “Despite efficiency gains, AI can produce fabricated information.”
  • Beckers Health IT adds,
    • More than 40 million Americans use ChatGPT daily to ask questions about healthcare, according to a new report from OpenAI that highlights how patients and clinicians are increasingly turning to AI to navigate a complex and strained U.S. healthcare system.
    • The report, AI as a Healthcare Ally: How Americans Are Navigating the System With ChatGPT, was shared with Becker’s by an OpenAI spokesperson. It is based on anonymized ChatGPT message data and OpenAI-led research.
    • The article offers eight findings from the OpenAI report.
  • Per Beckers Hospital Review,
    • “Nashville, Tenn.-based HCA Healthcare is facing resistance to its expansion efforts across multiple states, as competing health systems challenge the for-profit giant’s push to add new emergency rooms, surgery centers and hospitals in regions where it already has a presence.”
  • and
    • “Patients in Washington, D.C., had the highest median time spent in the emergency department, while patients in North Dakota had the lowest, CMS data shows.
    • “The agency’s “Timely and Effective Care” dataset, updated Nov. 26, tracks the average median time patients spend in the emergency department before leaving. The measures apply to children and adults treated at hospitals paid under the Inpatient Prospective Payment System or the Outpatient Prospective Payment System, as well as those that voluntarily report data on relevant measures for Medicare patients, Medicare managed care patients and non-Medicare patients.” 

Weekend update

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

From Washington, DC

  • The House of Representatives and the Senate return to Capitol Week to begin the second session of the 119th Congress with Committee business and floor voting.
  • Federal News Network reports,
    • “Lawmakers said the fiscal 2026 defense policy bill that became law earlier this month would deliver “the most significant acquisition reforms in a generation.” But some of the more sweeping proposals introduced in the House and Senate versions of the bill were ultimately scaled back or dropped entirely from the final version of the legislation.
    • “A similar dynamic played out inside the Pentagon. A draft acquisition memo circulated prior to Defense Secretary Pete Hegseth’s speech to defense executives and senior military acquisition officials outlined a far more aggressive overhaul of how the department would develop and buy military capabilities than what emerged in the final version of the memo and the Acquisition Transformation Strategy.
    • “But a number of provisions from the House’s SPEED Act and Senate’s FoRGED Act that survived negotiations are still expected to be impactful, including measures aimed at streamlining prototyping, accelerating the transition of technologies into production and expanding opportunities for small businesses and new entrants.”

From the public health and medical / Rx research front,

  • The Washington Post tells us “what viruses an infectious-disease doctor is watching for in 2026.”
  • The New York Times reports “Vaccines Are Helping Older People More Than We Knew. Many shots seem to have “off-target” benefits, such as lowering the risk of dementia, studies have found.”
  • STAT News informs us, a “Genetic variant appears to protect some people against certain blood cancers. Study reveals a potential path to develop therapies for a pre-cancerous condition called CHIP.”
  • Per Medscape,
    • “Eight percent of US adults older than 65 years have taken a GLP-1 agonist either to lose weight or to treat comorbidities like diabetes and cardiovascular disease. Older adults are drawn to the medications because of the many antiaging benefits — some medical experts have even called them a veritable “fountain of youth.”
    • “But both patients and physicians should also be aware of some of the drawbacks and potential side effects for which older adults are particularly susceptible like a dangerous reduction in muscle mass, bone loss, low blood pressure, and dehydration.
    • “Understanding this age group’s particular vulnerabilities [discussed in this article] can help physicians know what to look out for while also staving off some potential side effects before they become an issue.
  • Per Fierce Pharma,
    • “The emergence of next-generation KRAS G12C inhibitors has led Verastem Oncology to change course.
    • “The Boston biotech has decided to discontinue a phase 1/2 trial in advanced KRAS G12C-mutated non-small cell lung cancer (NSCLC) following an interim data analysis.
    • “Explaining the move in a Dec. 29 statement, Verastem’s chief medical officer, John Hayslip, M.D., said newer G12C inhibitors are “establishing a new benchmark with higher response rates.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Scottsdale, Ariz.-based HonorHealth wrapped its acquisition of 11 Evernorth Care Group locations Jan. 2. Evernorth is a subsidiary of The Cigna Group, according to its website. 
    • “HonorHealth agreed to acquire Evernorth Care Group in early September. At the time, Evernorth operated 18 clinics in the greater Phoenix area and offered integrated primary care services to almost 80,000 patients. However, HonorHealth only acquired 11 locations. 
    • “Arrowhead Ranch Center, Chandler Health Center, Paradise Valley Health Center, Paseo Health Center, Scottsdale Norte Health Center, Sun City Health Center and Westridge Health Center were not acquired in the transaction and are closed, according to HonorHealth.” * * *
    • HonorHealth comprises nine acute care hospitals, more than 200 primary, specialist and urgent care locations and more than 17,000 employees, according to its website.” 
  • and
    • “Health system C-suites across the U.S. are targeting ambulatory care expansion for 2026 as pressure mounts to lower cost of care and deliver on value-based promises.
    • “Even the nation’s largest health systems are strengthening their ambulatory footprints. Chicago-based CommonSpirit Health, which operates in 28 states, is focused on outpatient growth.
    • “Our best growth opportunities are in our ambulatory footprint and enhancing our patient care access,” said Shelly Schorer, CFO of the California Division of CommonSpirit Health, which already includes 125 ambulatory sites. “There’s still a need for the acute care setting, but we are seeing more and more services and healthcare procedures moving to the outpatient setting and I think we need to expand our ambulatory care footprint.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

Happy New Year!

From the cybersecurity policy and law enforcement front,

  • Federal News Network points out five things to watch in cybersecurity policy at the federal level during 2026.
    • “New national cyber strategy”
    • “AI and cyber”
    • “CISA 2015 reauthorization”
    • “CIRCIA rule” and
    • “Cyber leader gaps”
  • Security Week reports,
    • “Two cybersecurity professionals from the United States have pleaded guilty to charges related to their role in BlackCat/Alphv ransomware attacks, the Justice Department announced this week [December 30].
    • “Three individuals were charged in October for allegedly conducting ransomware attacks against several US-based companies. Two of the suspects, 36-year-old Kevin Martin from Texas and an unnamed individual, were employed as ransomware negotiators at threat intelligence and incident response firm DigitalMint.
    • “The third suspect, 40-year-old Ryan Goldberg from Georgia, worked as an incident response manager at cybersecurity company Sygnia.
    • “The three are accused of hacking into the systems of several companies, stealing valuable information, and deploying BlackCat ransomware. 
    • “Based on the Justice Department’s description of the scheme, the suspects were BlackCat ransomware affiliates, paying 20% of the ransoms they received from victims to the administrators of the ransomware operation in exchange for access to the file-encrypting malware and a platform designed for managing extortions.”

From the cybersecurity breaches and vulnerabilities front,

  • Bleeping Computer points out the 15 biggest cybersecurity and cyber attack stories of 2025.
  • Security Week adds,
    • “Insurance giant Aflac is notifying roughly 22.65 million people that their personal information was stolen from its systems in June 2025.
    • “The company disclosed the intrusion on June 20, saying it had identified suspicious activity on its network in the US on June 12 and blaming it on a sophisticated cybercrime group.
    • “The company said it immediately contained the attack and engaged with third-party cybersecurity experts to help with incident response. Aflac’s operations were not affected, as file-encrypting ransomware was not deployed.
    • “Just before Christmas, the Columbus, Georgia-based company announced it had completed its investigation into the potentially compromised data and had started notifying the affected individuals.
    • “Based on our review of potentially impacted files, we have determined personal information associated with approximately 22.65 million individuals was involved,” the company said.
    • “The compromised information, the insurance giant says, includes names, addresses, Social Security numbers, dates of birth, driver’s license numbers, government ID numbers, medical and health insurance information, and other data.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) added one known exploited vulnerability to its catalog this week.
  • Bleeping Computer informs us,
    • “IBM urged customers to patch a critical authentication bypass vulnerability in its API Connect enterprise platform that could allow attackers to access apps remotely.
    • “API Connect is an application programming interface (API) gateway that enables organizations to develop, test, and manage APIs and provide controlled access to internal services for applications, business partners, and external developers.
    • “Available in on-premises, cloud, or hybrid deployments, API Connect is used by hundreds of companies in banking, healthcare, retail, and telecommunications sectors.
    • “Tracked as CVE-2025-13915 and rated 9.8/10 in severity, this authentication bypass security flaw affects IBM API Connect versions 10.0.11.0 and 10.0.8.0 through 10.0.8.5.
    • “Successful exploitation enables unauthenticated threat actors to remotely access exposed applications by circumventing authentication in low-complexity attacks that don’t require user interaction.”
  • and
    • “Over 10,000 Fortinet firewalls are still exposed online and vulnerable to ongoing attacks exploiting a five-year-old critical two-factor authentication (2FA) bypass vulnerability.
    • “Fortinet released FortiOS versions 6.4.1, 6.2.4, and 6.0.10 in July 2020 to address this flaw (tracked as CVE-2020-12812) and advised admins who couldn’t immediately patch to turn off username-case-sensitivity to block 2FA bypass attempts targeting their devices.
    • “This improper authentication security flaw (rated 9.8/10 in severity) was found in FortiGate SSL VPN and allows attackers to log in to unpatched firewalls without being prompted for the second factor of authentication (FortiToken) when the username’s case is changed.
    • “Last week, Fortinet warned customers that attackers are still exploiting CVE-2020-12812, targeting firewalls with vulnerable configurations that require LDAP (Lightweight Directory Access Protocol) to be enabled.
    • “Fortinet has observed recent abuse of the July 2020 vulnerability FG-IR-19-283 / CVE-2020-12812 in the wild based on specific configurations,” the company said.”
  • and
    • “Trust Wallet believes the compromise of its web browser to steal roughly $8.5 million from over 2,500 crypto wallets is likely related to an “industry-wide” Sha1-Hulud attack in November.
    • “Trust Wallet, a crypto wallet used by over 200 million people, enables users to store, send, and receive Bitcoin, Ethereum, Solana, and thousands of other cryptocurrencies and digital tokens via a web browser extension and free mobile apps.
    • “As BleepingComputer previously reported, this December 24th incident resulted in the theft of millions of dollars in cryptocurrency from the compromised wallets of Trust Wallet users.
    • This happened after attackers added a malicious JavaScript file to version 2.68.0 of Trust Wallet’s Chrome extension, which stole sensitive wallet data and enabled threat actors to execute unauthorized transactions.
    • “Our Developer GitHub secrets were exposed in the attack, which gave the attacker access to our browser extension source code and the Chrome Web Store (CWS) API key,” the company said in a Tuesday [December 30] update.
  • and
    • “A fourth wave of the “GlassWorm” campaign is targeting macOS developers with malicious VSCode/OpenVSX extensions that deliver trojanized versions of crypto wallet applications.
    • “Extensions in the OpenVSX registry and the Microsoft Visual Studio Marketplace expand the capabilities of a VS Code-compatible editor by adding features and productivity enhancements in the form of development tools, language support, or themes.
    • “The Microsoft marketplace is the official extension store for Visual Studio Code, whereas OpenVSX serves as an open, vendor-neutral alternative, primarily used by editors that do not support or choose not to rely on Microsoft’s proprietary marketplace.”
    • “The GlassWorm malware first appeared on the marketplaces in October, hidden inside malicious extensions using “invisible” Unicode characters.”
    • “Once installed, the malware attempted to steal credentials for GitHub, npm, and OpenVSX accounts, as well as cryptocurrency wallet data from multiple extensions. Additionally, it supported remote access through VNC and can route traffic through the victim’s machine via a SOCKS proxy.
    • “Despite the public exposure and increased defenses, GlassWorm returned in early November on OpenVSX and then again in early December on VSCode.”

From the ransomware front,

  • Cybersecurity Insiders recounts the top ransomware attacks of 2025.
  • SC Media tells us,
    • “HackRead reports that U.S. automaker Chrysler had over 1 TB of data, including more than 105 GB of Salesforce-related information, claimed to have been exfiltrated by the Everest ransomware gang.
    • “Allegedly included in the stolen data trove spanning between 2021 and 2025 were personal and operational records from customers, internal agents, and dealers, with screenshots revealing internal spreadsheets, structured databases, CRM exports, and directory trees, as well as customer interaction logs with names, physical and email addresses, phone numbers, vehicle details, recall case notes, and call outcomes.” * * *
    • “Everest has warned that it would release not only the entire dataset but also customer service-related audio recordings purportedly stolen from Chrysler should it refuse to fulfill its demands.”
  • Morphisec points out,
    • “In Morphisec’s recent CTO Briefing: The State of Ransomware, CTO Michael Gorelik highlighted one of the most significant and troubling shifts in the ransomware landscape: many ransomware attacks no longer involve encryption at all.   
    • “Instead, attackers quietly steal sensitive data—sometimes over weeks or months—and then extort victims long after the breach. This “ransomware without encryption” model is growing rapidly because it has lower risk for attackers, harder for defenders to detect, and nearly impossible for victims to investigate once logs have aged out.”  

From the cybersecurity defenses front,

  • Dark Reading calls attention to
    • “Cybersecurity Predictions for 2026: Navigating the Future of Digital Threats. Cybersecurity experts discuss 2026 predictions, highlighting the rise of AI-driven threats, the shift to resilience over prevention, and the urgent need for advanced security measures to combat evolving risks”
  • and
    • “5 Threats That Defined Security in 2025. 2025 included a number of monumental threats, from global nation-state attacks to a critical vulnerability under widespread exploitation.”
      • “Salt Typhoon continues its onslaught”
      • “CISA see big layoffs and budget cuts”
      • “React2Shell carries echos of Log4Shell.
      • “Shai-Hulud opens floodgates on self-propagating Open Source Malware.” and
      • “Threat Campaigns Target Salesforce Customers.”
  • and
    • “The Ivanti Endpoint Manager Mobile (EPMM) zero-day attacks, which began last spring and lasted well into the summer as attackers took advantage of patching lag, were one of the top cyber-stories of 2025, sending thousands of victims to the depths of the data exfiltration sea. A recent deep-dive into the wreckage of those attacks highlights the risk inherent in buggy endpoint management systems — a concern that needs to be a higher priority than it typically is, one researcher argues.”
  • SC Media notes,
    • “A whopping 99% of security leaders plan to increase their cybersecurity budgets over the next two to three years, signaling that cybersecurity has become a critical business imperative, according to a KPMG Cybersecurity Survey released earlier this month.
    • “KPMG’s survey, which polled more than 300 C-suite and senior security leaders, found that the projected spending increases come at a time when 83% of organizations report a rise in cyberattacks, which include everything from phishing and ransomware to more advanced AI-powered social-engineering schemes.
    • “The data doesn’t just point to steady growth, it signals a potential boom,” said Michael Isensee, cybersecurity and tech risk leader, KPMG LLP. “We’re seeing a major market pivot where cybersecurity is now a fundamental driver of business strategy.
    • “Leaders are moving beyond reactive defense and are actively investing to build a security posture that can withstand future shocks, especially from AI and other emerging technologies,” continued Isensee. “This isn’t just about spending more, it’s about strategic investment in resilience.”
  • Security Affairs warns,
    • “Your next breach probably won’t start inside your network—it will start with someone you trust. Every supplier, contractor, and service provider needs access to your systems to keep business running, yet each login is a potential doorway for attackers. Access management is meant to control the risks of granting that access, but weak controls and poor hygiene remain the norm. The Thales Digital Trust Index report, Third-Party Edition, highlights that over half of surveyed professionals (51%) keep access to partner systems for days or even a month after they no longer need it, turning everyday collaborations into hidden vulnerabilities that accumulate over time.
    • “Ask yourself: Are you evaluating and managing these risks well enough? If the answer isn’t clear, it’s time to revisit the basics of identity lifecycle management. Supply chain risks are preventable—but only if they aren’t tolerated or ignored. This article is a primer on how to ensure B2B collaboration remains a source of agility and resilience, not your Achilles’ heel.”
  • Here is a link to Dark Reading’s CISO Corner.

First FEHBlog Report of 2026

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

Happy New Year!

From Washington, DC

  • OPM Director Scott Kupor added a post to his Secrets of OPM blog about return to office policies.
  • Federal News Network reports,
    • “The specifics of a larger federal pay raise for law enforcement officers are coming into view, following President Donald Trump’s directive to offer a 3.8% salary increase for certain positions.
    • “In a memo Wednesday, the Office of Personnel Management established new “special salary rates” for federal law enforcement personnel [December 31], as a way to implement the bigger raise for 2026.”
  • MedPage Today tells us,
    • “The FDA approved tradipitant (Nereus), an oral neurokinin-1 (NK-1) receptor antagonist, to prevent vomiting induced by motion in adults, Vanda Pharmaceuticals announcedopens in a new tab or window Tuesday.
    • “The approval marks the first new drug treatment for motion sickness in over four decades and signifies an advancement in understanding motion sickness mechanisms, the company said.”

From the judicial front,

  • Federal News Network reports,
    • “The Trump administration is facing a new legal complaint from a group of government employees who are affected by a new policy going into effect Thursday that eliminates coverage for gender-affirming care in federal health insurance programs.
    • “The complaint, filed Thursday [with the Equal Employment Opportunity Commission] on the employees’ behalf by the Human Rights Campaign, is in response to an August announcement from the Office of Personnel Management that it would no longer cover “chemical and surgical modification of an individual’s sex traits through medical interventions” in health insurance programs for federal employees and U.S. Postal Service workers.
    • “The complaint argues that denying coverage of gender-affirming care is sex-based discrimination and asks the personnel office to rescind the policy.” * * *
  • Bloomberg Law informs us,
    • “Drugmakers Eli Lilly & Co., Novo Nordisk Inc., and Sanofi-Aventis US LLC and pharmacy benefit managers such as Express Scripts won’t face certain civil fraud claims in connection with alleged price-fixing of diabetes treatment drugs.
    • “The plaintiff health benefit managers and trusts were barred from asserting civil claims under the Racketeer Influenced and Corrupt Organizations Act because they didn’t directly purchase the drugs, but rather reimbursed their members for the cost, the US District Court for the District of New Jersey said Tuesday.
    • “The “indirect purchaser rule” developed by the US Supreme Court in the antitrust context holds that Clayton Act plaintiffs may not demonstrate injury by providing evidence only of indirect purchases.
    • “Judge Brian Martinotti said the rule also applies in RICO cases, citing recent decisions from the US Court of Appeals for the Third Circuit applying it in factual situations similar to that alleged here because RICO’s private cause of action was modeled on the Clayton Act.”

From the public health and medical / Rx research front,

  • Due to New Years Day falling on a Thursday, the Centers for Disease Control and Prevention released their respiratory news update last Tuesday, December 30.
    • “As of December 30, 2025, the amount of acute respiratory illness causing people to seek health care is at a high level for the first time in the current 2025-2026 season.
    • “Seasonal influenza activity is elevated and continues to increase across the country.
    • “RSV activity is elevated in many areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “COVID-19 activity is low but increasing nationally.”
  • STAT News relates,
    • “Babies who don’t get their first round of vaccines on time at 2 months of age are much less likely to get vaccinated against measles, mumps, and rubella by age 2, according to a new study that suggests pediatricians may have a narrow window in which to persuade parents to follow the recommended childhood vaccination schedule. 
    • “The study, published Friday in JAMA Network Open, reports that in the post-Covid-19 pandemic period, babies who didn’t get their shots on time at 2 months — the age at which the Centers for Disease Control and Prevention recommends babies get vaccines against a host of diseases — were more than seven times more likely not to receive their first measles, mumps, and rubella (MMR) shot by age 2, which is months later than when that shot is supposed to be given. Babies are supposed to get their first MMR shot between 12 months and 15 months of age, with a second sometime between the ages of 4 and 6.
    • “There’s evidence from this study that very early vaccination delays lead to later vaccination delays and even missed vaccination for measles,” said Nina Masters, an epidemiologist who is the lead author of the paper. “This shows that hesitancy is really starting early and has a long arc.”
    • “And as we look at a really bad measles year, it’s really important to do whatever we can to try to increase measles vaccination coverage.” 
  • Healio tells us,
    • “Early-onset preeclampsia was associated with increased risk for delayed early-childhood development in the domain of problem-solving among preterm children, researchers reported.
    • “Although other domains of child development were affected by hypertensive disorders of pregnancy (HDP) and its subtypes, the relationships were not statistically significant, according to data published in JAMA Network Open.
  • MedPage Today recounts what happened with bird flu in 2025.
  • The Wall Street Journal lets us know,
    • “Move over weight loss and dry January. There’s a new popular New Year’s resolution in town: Enter the digital detox.
    • “Some people are aiming to reduce overall screen-time or social-media use (including yours truly). Others want to carve out regular no-screen days—OK, maybe more like time periods—or days or retreats.
    • “A survey by the digital-wellness app Opal (granted, a bit of a biased audience) found that 33% of 1,306 users said reducing screen times and being more present was their top New Year’s resolution, compared with 28% who aimed to lose weight. 
    • “Even teens are voicing a desire to reduce screen time. A Boston Children’s Digital Wellness Lab report cited results from a survey of more than 1,500 teens and found that 63% said they use their phones too much and 47% said they used apps or tools to manage phone use. 
    • “It’s high time we all cut down. There are growing signals it’s bad for our mental health—especially among adolescents and young adults.
    • “A recent study in JAMA Network Open found that when young adults did a social-media detox for a week they had a reduction in anxiety and depression symptoms, as well as less insomnia.”
  • The Washington Post points out,
    • A fatty particle can clog arteries just as surely as cholesterol but often goes undetected, striking seemingly healthy people unaware of the danger. Though tests are widely available, they aren’t routinely ordered — in part because there are no approved treatments for the genetic disorder.
    • Now, cardiologists waging a campaign against lipoprotein(a) say they are reaching a turning point. Five experimental drugs are in late stages of development and aim to prove that lowering levels of Lp(a) — pronounced “L-P-little-A” — reduces heart attacks and strokes. Results from the most advanced clinical trial are expected in the first half of 2026.
    • “Cardiologists, drugmakers and Wall Street analysts are optimistic that these new drugs can effectively treat a disorder that is estimated to affect about 20 percent of the world’s population. Even if they prove effective, the cost of a novel drug — as well as the scant public awareness of Lp(a) — could be a barrier to treating patients who might benefit.
    • “There are over a billion people on our planet that have elevated lipoprotein levels and that are at increased risk,” said Steve Nissen, a cardiologist at Cleveland Clinic whose team is leading trials on four drugs targeting Lp(a). “We will have a massive educational job to do.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Hartford HealthCare closed its $86.1 million purchase of two Connecticut cate care hospitals, the 249-bed Manchester Memorial and its 109-bed Rockville campus, plus their related assets, from bankrupt Prospect Medical Holdings on Jan. 1.
    • “The transaction comes after the system spent months securing regulatory and state approvals, which involved commitments to maintain certain services and limit its rate negotiations with payers during the next few years. The most recent of these, an agreement with Connecticut Attorney General William Tong, came on Dec. 29
    • “Hartford HealthCare said it also plans to invest $225.7 million over three years into the hospitals and their communities. These efforts, as highlighted in this week’s announcement, include additional hiring, stronger outpatient and ambulatory care services, 24/7 virtual primary care offerings and the reopening of a 30-bed behavioral care unit at Rockville.”
  • Reuters relates,
    • “Drugmakers plan to raise U.S. prices on at least 350 branded medications including vaccines against COVID, RSV and shingles and blockbuster cancer treatment Ibrance, even as the Trump administration pressures them for cuts, according to data provided exclusively by healthcare research firm 3 Axis Advisors.
    • “The number of price increases for 2026 is up from the same point last year, when drugmakers unveiled plans for raises on more than 250 drugs. The median of this year’s price hikes is around 4% – in line with 2025.
  • Genetic Engineering and BioTechnology News calls attention to “Seven Biopharma Trends to Watch in 2026.”
  • Beckers Clinical Leadership tells us
    • “Of the 650 U.S. hospitals designated as “Magnet” hospitals for nursing excellence, about 5% have earned the recognition more than six times. 
    • “The American Nurses Credentialing Center awards Magnet recognition to hospitals based on their quality of patient care and nursing excellence. As of Dec. 31, 33 hospitals have received six or more Magnet designations — representing just 0.54% of the nation’s 6,093 hospitals.”
    • The article lists those 33 hospitals by State.  

Happy New Year 2026

David Ermer–ACA, Congress, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–

Happy New Year. This year is the 250th anniversary of our Nation’s independence. The FEHBlog resolves to keep posting as the 20th anniversary of the FEHBlog also occurs in 2026.

From Washington, DC,

  • Federal News Network reports,
    • “The Office of Personnel Management is addressing what have become growing concerns in Congress over the significant delays in federal retirement processing this year.
    • “In a letter sent Tuesday [December 30] to a group of House Democrats, OPM Director Scott Kupor touted the benefits of the new online retirement application (ORA) in helping to streamline processing, while at the same time arguing that outdated systems — not staffing levels — are to blame for the current challenges HR employees are facing.
    • “The main issues with federal HR, we have found, are not low staffing levels, but inefficient and outdated technology and antiquated, cumbersome regulations and processes,” Kupor wrote in the Dec. 30 letter, obtained by Federal News Network. “OPM under the Trump administration has done in a matter of months what the government failed to do for multiple generations: modernize the paper-based federal retirement system.”
    • “Kupor’s comments are a response to a Dec. 22 letter from Democrats on the Oversight and Government Reform Committee, which raised concerns about the significant delays retiring federal employees are currently experiencing. Those delays are largely due to a surge of retirement applications from employees who opted into the deferred resignation program (DRP) earlier this year.”
  • FEHBlog Observation: A related solution would be to simplify the highly complex retirement programs.
  • An OPM news release describes the agency’s other accomplishments in 2025.
  • Beckers Payer Issues identifies major federal and state healthcare policies that first take effect in 2026. The FEHB is hoping for significant deregulation of the FEHB and PSHB Programs which is the surest path to lower premiums and better competition.
  • Fedweek tells us,
    • “The 2026 general schedule pay raise as usual will take effect not at the start of the year but rather as of the first full pay period of the year—January 11-24 for most—and its impact won’t be seen in pay distributions until the one covering that pay period, which in most cases will be made about a week to 10 days after its end.
    • “The raise of 1 percent across the board for most, although 3.8 percent for certain law enforcement positions (pending an OPM review), also as usual will have an effect on pay caps and certain benefits.
    • “The GS pay cap is increasing from $195,200 to $197,200. That cap affects employees in the upper steps of GS-15 in about half of the GS localities, and the upper steps of GS-14 in the highest paid, the San Francisco-Oakland locality.”
  • FEHBlog observation — FEHB Open Season changes for annuitants take effect on January 1, 2026, while Open Season changes for employees takes effect on the first day of the first pay period of 2026, which is January 11, 2026. Open Season changes in the Postal Service Health Benefits program for all enrollees take effect on January 1, 2026.

From the judicial front,

  • Beckers Payer Issues reports,
    • “Health Care Service Corp.’s Blue Cross and Blue Shield of Texas filed a lawsuit against medical billing company Zotec Partners Dec. 18, alleging “abuse” of the No Surprises Act’s independent dispute resolution process, according to filings from the Eastern District of Texas’ federal court.
    • “The No Surprises Act aims to limit surprise billing, forming the resolution process to address payment disputes between insurance companies and out-of-network providers.
    • “BCBS of Texas accused Zotec of knowingly instigating “thousands” of disputes that were not eligible for arbitration, such as by submitting false information. The insurer said Zotec sometimes ignored state law, timelines for the IDR process and eligibility parameters for claims. “Batching” — or bundling multiple claims into one IDR process — has been another concern, with BCBS of Texas saying Zotec “overwhelms” the insurer by including 66 unique items or services on average.
    • “The complaint requested compensation and a court order that would block Zotec from launching ineligible cases going forward.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Alabama insurers issued the highest amount of medical loss ratio rebates to consumers in 2024, according to KFF.
    • “Under the ACA, if an insurer in the individual market spends less than 80% of premium revenues on clinical services and quality improvement, it is required to provide a rebate to customers, based on a 3-year average.”
  • Beckers Hospital Review points out,
    • “Cross-market mergers — transactions between health systems operating in separate geographic regions — are becoming a more prominent trend in hospital consolidation as organizations continue to shift toward multiregion operating models.
    • “Over the past year, several large systems have pursued cross-market deals to gain scale, diversify risk and strengthen payer negotiations, often in lieu of same-market mergers that face heightened antitrust scrutiny. 
    • “While these transactions typically do not eliminate local competition for patients, they are reshaping how health systems think about growth, leverage and long-term sustainability.”
  • MedCity News adds,
    • “Workforce pressures remained the dominant financial challenge for hospitals and health systems in 2025, according to data released this month by Kaufman Hall.
    • “Labor is still the largest expense for hospitals, with about 70% of organizations pursuing widespread efforts focused on staffing optimization.
    • “The interesting trend within the workforce setting is that more than half [of hospitals] are looking at the potential outsourcing of non-core activities. This has always been a trend in healthcare, but it seems to be increasing as people look to improve some of the non-core competencies, such as food service, revenue cycle, HR, etc.,” said Lance Robinson, managing director at Kaufman Hall.” * * *
    • “Beyond pay, hospitals are rethinking care models, Robinson added. They are placing more of an emphasis on team-based staffing, as well as investing in technologies like ambient AI to reduce administrative burden and help clinicians work at the top of their license.”

Tuesday report

David Ermer–ACA, HIPAA Privacy and Security Rules, Medical / Rx research, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Govexec identifies the five biggest stories for federal agencies and employees to watch in 2026.
    • 1.) Renewed shutdown watch
    • 2.) Return of RIFs? 
    • 3.) The implementation of ‘Schedule F’ and other changes to the civil service
    • 4.) Agency reorganizations
    • 5.) Court battles 
  • Beckers Payer Issues informs us,
    • “More than 15.6 million people have enrolled in plans on federally run ACA exchanges so far, down from about 16 million at the same point last year, CMS Administrator Mehmet Oz, MD, said Dec. 23.
    • “Dr. Oz attributed the decline to efforts to address fraudulent enrollments, writing on X: “Notably, this small drop follows several important CMS actions over the past year to combat fraudulent and improper enrollments, which have already removed more than enough people from premium subsidies who are covered elsewhere to account for the modest enrollment change. That said, there is a politically motivated lawsuit that has paused critical actions to make sure Biden-era improper enrollments are fully knocked out.”
    • ‘Earlier in the open enrollment period, ACA enrollment was outpacing last year. CMS data published Dec. 5 showed nearly 5.8 million plan selections through late November, up about 7% year over year, though new consumer enrollment was down 4% as returning consumers drove the gains.”
  • According to a Competitive Enterprise Institute news release,
    • “A new Competitive Enterprise Institute (CEI) study explores a thriving pharmaceutical delivery system that offers consumers real choice and convenience. Independent pharmacies are doing well and still make up a sizable portion of retail pharmacies. At the same time, new approaches like mail-order pharmacies and combined telehealth and pharmacy offerings are making it easier and cheaper than ever for patients to obtain necessary medications. And these new innovative approaches are providing access to rural areas that lack physical pharmacies.
    • “Invaluable to this well-functioning system is the role of pharmacy benefit managers (PBMs). PBMs own and manage most mail-order pharmacies, negotiating drug prices and running an efficient distribution network. PBMs provide convenient, reliable drug delivery to patients, making it easier for patients to stick to their treatment plan.
    • “But some lawmakers at the state and federal levels fear that PBMs wield too much influence over products and services, and they want to ban PBMs from owning pharmacies, whether mail-order services or retail stores like CVS. Perhaps they have not considered that in some rural counties, the only pharmacy available would be in danger of closing under these laws—potentially leaving residents in those areas with no local options.
    • “There is little evidence to suggest that worries about PBM-owned pharmacies are justified, and consumers are already protected from anticompetitive practices by existing laws.
    • “Banning successful business models doesn’t protect consumers; it protects competitors from competition,” said study author and CEI senior fellow Jeremy Nighohossian. “When it comes to building a system that works better for consumers, the free market is the best medicine.”
  • Modern Healthcare reports,
    • “The Drug Enforcement Administration on Tuesday temporarily extended a rule allowing clinicians to prescribe controlled medications remotely through the end of 2026.
    • “The rule, which will take effect Thursday, gives clinicians the ability to remotely prescribe Schedule II-V controlled medications to patients. This latest extension marks the fourth time the rule has been renewed since it was implemented at the beginning of the COVID-19 pandemic.
    • “Under the rule, clinicians are able to prescribe controlled medications, such as Adderall and Xanax via telemedicine appointments, without an initial in-person examination. The rule was originally set to expire at the end of December.”
  • The Holland and Knight law firm lets us know,
    • “Recent changes to the HIPAA Privacy Rule require that healthcare providers update their Notice of Privacy Practices (“NPP”) by February 16, 2026. The changes are intended to align HIPAA with the revised regulations governing substance use disorder records in 42 CFR part 2 (“Part 2”). A redlined version of 45 CFR 164.520 showing the changes to the rule is available here here.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Influenza cases are rising sharply, heightening fears that a new strain will fuel a punishing flu season that is already outpacing last year’s.
    • “The flu has sickened an estimated 7.5 million people so far this season, according to weekly data from the Centers for Disease Control and Prevention released Tuesday. About 81,000 people have been hospitalized and 3,100 have died so far this flu season, the agency estimated, including eight children. That reflects a sharp increase from the week prior, in which the CDC estimated about 4.6 million cases, 49,000 hospitalizations and 1,900 deaths. 
    • “Roughly 25% of samples sent to clinical laboratories came back positive for the flu in the week ended Dec. 20, the CDC said. That is up from about 15% the week before. 
    • “The figures raised concerns of a particularly harsh flu season this winter. The contagious respiratory illness typically kills thousands of people in the U.S. each year, though that number can rise significantly in years with troublesome viral variants.” 
  • The University of Minnesota’s CIDRAP tells us,
    • “Measles cases nationwide have reached 2,012, the Centers for Disease Control and Prevention (CDC) reported last week, as outbreaks in Arizona and South Carolina continue to grow and three other states alert the public about airport exposures.
    • “The US total reflects 54 new cases, as the country teeters on the brink of losing its measles elimination status—which it earned in 2000—next month. This year’s total is the nation’s highest since 1992, when officials reported 2,200 cases. Coordinated vaccination efforts led to a precipitous drop in cases in the ensuing decades, but vaccine skepticism in recent years has spawned the disease’s resurgence.”
  • and
    • “Relative to uninfected control patients, those hospitalized with acute respiratory infections (ARIs) due to respiratory syncytial virus (RSV) or influenza were at substantially higher adjusted risk for all-cause death, heart attack, exacerbation of asthma and chronic obstructive pulmonary disease (COPD), and hospitalization for heart failure, researchers from vaccine maker GSK and the Analysis Group report.
    • “The retrospective study, published last week in Clinical Infectious Diseases, used claims data from October 2015 to June 2023 to compare clinical outcomes among US adults aged 50 and older hospitalized for RSV or flu with those of controls without ARI. The average ages in the RSV and flu cohorts were higher than those of controls (76.5 and 75.4 vs 69.5 years, respectively).
    • “Current evidence on longer-term RSV-ARI outcomes among adults aged ≥50 years is limited, with insufficient research comparing the impact of RSV-ARI hospitalization to an appropriate comparator population representing the long-term health outcomes these patients would have experienced without severe RSV disease,” the study authors wrote.”
  • The New York Times relates,
    • “Rarely does a single study change the course of gynecological history. But a clinical trial published this year in The New England Journal of Medicine did just that, seeming to close the door on one of the great enigmas of women’s health.
    • “Bacterial vaginosis, or B.V., is the most common vaginal infection worldwide. If you have a vagina, there’s a one-in-three chance you will have B.V. at some point in your life.
    • “For years, doctors have known that the bacteria associated with the condition could also be found on the penis. Yet on paper B.V. was just a vagina problem — it’s right there in the name, vaginosis. For 50 years, gynecology treated it as if it were solely a women’s issue, with ineffective treatments that left women vulnerable to re-infection.
    • “The New England Journal study changed that. The researchers followed 150 heterosexual couples in which the female partner had bacterial vaginosis. They treated the women with first-line antibiotics, and half the men with both oral and topical antibiotics. Within three months, they found, the partner treatment worked so well that they had to disband the study so all participants could be treated.”
  • Medscape points out,
    • “Rates of gestational diabetes (GD) in the US rose every year from 2016 to 2024, with a total 36% jump in that 9-year period, new data showed.
    • “The data, from nearly all first live singleton births recorded in the National Center for Health Statistics, also showed that GD rose among all racial and ethnic groups, but with significant differences among them.
    • “The dramatic GD rise “likely reflects several factors including increasing prevalence of prepregnancy overweight and obesity, older maternal age at first birth, and higher rates of metabolic risk factors entering pregnancy. The COVID-19 pandemic may have further contributed to these trends through disruptions in routine preventive care, reduced physical activity, increased psychosocial stress, and weight gain during the pandemic period,” study first author Emily L. Lam, medical student at Northwestern University, Chicago, told Medscape Medical News.”

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

  • Fierce Healthcare reports,
    • “Brooklyn, New York-based Maimonides Health is merging with New York City’s public health system NYC Health + Hospitals, the organizations announced Dec. 29.
    • “The merger is pending final legal and regulatory approval but is expected to be finalized by April, city officials said.
    • “The partnership is supported by $2.2 billion over five years from New York state to protect safety net healthcare in Brooklyn, officials said.”
    • “Maimonides Health is a Brooklyn healthcare system with three hospitals and more than 80 community-based sites. By partnering with the city, Maimonides will be reimbursed at a higher rate by Medicaid, bolstering its financial position, health system executives said in a press release. 
    • “The merger also allows Maimonides to adopt a new Epic electronic health record platform. Health system executives said the move to Epic would help improve care coordination and the organization’s ability to collect revenue. Maimonides patients will be able to access their health records online and contact their care team digitally through the portal.”
  • Per Beckers Health IT,
    • “Healthcare organizations are increasingly adopting artificial intelligence to improve efficiency and reduce administrative burden, but most remain cautious about deploying AI in high-risk clinical scenarios, a Dec. 29 KLAS Research report found.”

Monday Report

David Ermer–CMS, Medical / Rx research, No Surprises Act, OPM, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Dec. 29 announced $50 billion in funds awarded to all 50 states through the Rural Health Transformation Program. Beginning in 2026, states will receive first-year awards averaging $200 million to expand access to care, bolster the rural workforce, modernize facilities and technology, and support innovative payment and care delivery models. 
    • “Funds will be allocated over the next five years, with $10 billion available each year through 2030. Fifty percent of the funding is distributed equally among all approved states, while the additional 50% is allocated based on rural health needs and proposed impact.” 
  • Federal News Network informs us,
    • “Probationary federal employees are on track to see more restrictions when appealing any future terminations, according to a new proposal from the Trump administration.
    • “Under new proposed regulations from the Office of Personnel Management, fired probationary employees would only be able to appeal their termination if they believe it was due to discrimination based on “partisan political reasons” or “marital status” — or if their agency diverged from standard termination procedures.
    • “These limited grounds of appeal for probationary terminations reflect the historical principle that probationary periods serve as a critical evaluation phase for new federal employees, and thus that agencies should enjoy great flexibility in separating employees serving probationary or trial periods,” OPM wrote in its proposal, which is scheduled to be published Tuesday on the Federal Register.
    • “Generally, OPM’s regulations seek to alter both the latitude and method for probationary federal employees to appeal an agency’s decision to fire them. Along with limiting options for appeal, the proposal would put OPM in charge of adjudicating employees’ cases, rather than the Merit Systems Protection Board.”

From the judicial front,

  • Bloomberg Law reports,
    • “A federal judge issued a preliminary injunction against a new government pilot set to significantly shift how certain health-care providers access steeply discounted medicines from drugmakers, halting the program from going into effect Jan. 1, 2026.
    • “Judge Lance E. Walker of the US District Court for the District of Maine ruled Monday that hospital groups suing the US Department of Health and Human Services over its new 340B Rebate Model Pilot Program demonstrated they’ll suffer irreparable harm in order for the court to grant a temporary block on the plan.
    • “The order hands a win to the American Hospital Association, the Maine Hospital Association, and other safety-net health systems that sued the government Dec. 1, alleging violations of the Administrative Procedure Act because the health department ignored comments about shifting the program to a rebate model.”
  • and
    • “A series of class actions over the exclusion of coverage for GLP-1 weight loss drugs is testing several legal strategies against how health insurance plans decide which drugs to cover and why.
    • “The cases target health insurance giants CareFirst BlueCross BlueShield, CVS Caremark, the Cigna Group, and Elevance Health Inc., alleging they and their pharmacy benefit managers breached their fiduciary duties under the Employee Retirement Income Security Act by discriminating against people with obesity and illegally denying coverage for Eli Lilly & Co.’s Zepbound, the only drug approved for sleep apnea.
    • “The lawsuits highlight the broadening dilemma that insurers and employers face in deciding whether to cover the blockbuster shots, as their popularity surges and lower cash prices come available to consumers outside of health plans. But pressure for coverage is likely to increase as the list of conditions the drugs are approved for continues to grow and as a newly approved pill is poised to increase demand.
    • “There’s more policy momentum to scrutinize exactly these kinds of PBM practices on the whole,” said Elizabeth McCuskey, a health law professor at Boston University. “So I think this adds a little fuel to that fire.”
  • The Proskauer law firm adds,
    • “In another development in the ongoing litigation over the enforceability of Independent Dispute Resolution (“IDR”) awards issued under the No Surprises Act (“NSA”), two air ambulance providers, Guardian Flight LLC and Med‑Trans Corporation, have filed a petition for writ of certiorari with the U.S. Supreme Court, seeking review of the Fifth Circuit’s decision holding that the NSA provides no private right of action to enforce IDR awards.  The petition asks the Court to decide a key question that has divided federal courts across the country: whether the NSA permits providers to bring private causes of action to enforce IDR awards in court.  Should the Supreme Court grant cert, the outcome of the case could have broad implications for the enforceability of NSA arbitration awards, a key feature of the NSA’s regulatory framework.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “An NBC News/Stanford University investigation has found widespread declines in kindergarten vaccination against tetanus. In states that provided data back to 2019, more than 75% of counties and jurisdictions across the U.S. have seen downward trends in young children getting the diphtheria-tetanus-pertussis (DTaP) series of shots. The vaccine is first given to babies at 2 months.
    • “Because tetanus isn’t spread from person to person, there isn’t a herd immunity threshold, but reductions in vaccination rates leave more people vulnerable to the disease.”
  • The American Medical Association lets us know what doctors wish their patients knew about Wilson disease.
    • “Wilson disease is a rare genetic condition that causes copper to build up in the body, often damaging the liver, brain and other organs before symptoms are recognized. Early signs of the condition—also called Wilson’s disease and named for the British neurologist who described it in 1912—can be subtle or mistaken for more common conditions. Because of that, many people live with the disorder for years before receiving the diagnosis that can change the course of their health.”
  • The Washington Post relates,
    • “University of Pennsylvania researcher Ran Barzilay is a father of three. His first two children received cellphones before they turned 12. But this summer, as early results from his own study on screens and teen health rolled in, he changed course. His youngest? Not getting one anytime soon.
    • “Barzilay’s analysis of more than 10,500 children across 21 U.S. sites found that those who received phones at age 12, compared with age 13, had a more than 60 percent higher risk of poor sleep and a more than 40 percent higher risk of obesity.
    • “This is not something you can ignore for sure,” said Barzilay, a professor of psychiatry and a child-adolescent psychiatrist at the Children’s Hospital of Philadelphia.”
  • Medscape considers whether “Relative Fat Can Replace Mass BMI in Assessing Obesity?”
    • “Developed and validated in 2018 using data from the National Health and Nutrition Examination Survey (NHANES), RFM is a sex-specific anthropometric measure of obesity that estimates body fat percentage based on height and waist circumference using the following formula:
      • “RFM = 64 − (20 × height/waist circumference) + (12 x sex [0 for males and 1 for females])
    • “This simple calculation incorporates waist circumference as a proxy of visceral body fat while accounting for sex-based differences in fat mass. Multiple studies have shown RFM to be a superior and more consistent predictor of cardiometabolic risk and mortality. 
    • “Obesity cutoffs were derived from NHANES (1999-2014) data linking RFM with all-cause mortality. After adjusting for age, BMI category, ethnicity, education, and smoking status, this analysis suggested that higher RFM was associated with substantially increased mortality risk. Women with an RFM of ≥ 40% (40% body fat) and men with an RFM of ≥ 30% (30% body fat) had a 50% higher risk of death compared with women with an RFM of ≤ 35% and men with an RFM of ≤ 25%. Additionally, women with an RFM of ≥ 45% had nearly double the risk of death, whereas men with an RFM of ≥ 35% had more than 2.5 times the risk of death.”
  • The Wall Street Journal tells us,
    • “It’s the leading cause of disability and one of the most costly health challenges of our time: chronic lower back pain.
    • “Yet effective and safe treatments are few and far between, leading patients to try everything from supplements to acupuncture to cannabis for relief.
    • “Now, two new studies provide some of the most comprehensive evidence yet that THC—the psychoactive compound in cannabis that creates the high—in combination with other parts of the cannabis plant may provide safe and effective relief. The two large, Phase 3 clinical trials demonstrated that the THC product is safe and more effective at reducing chronic lower back pain than placebo or opioids.
    • “Unfortunately, the news, while promising, won’t provide immediate relief for the more than 70 million U.S. adults who suffer from chronic lower back pain. The product tested is expected to be available in parts of Europe next year, while the path to approval in the U.S. will require another clinical trial.”
  • Beckers Hospital Review identifies “eight recent drug shortages and discontinuations, according to the FDA’s drug supply databases.”

From the U.S. healthcare business front,

  • The American Medical Association reports,
    • “Physicians continue to use telehealth at far higher levels than they did before the COVID-19 public health emergency, but an AMA report shows that the practice setting in which a physician delivers care can influence how often they use the technology.
    • “Overall, 71.4% of physicians reported using telehealth in 2024. That figure is far higher than the 25.1% of physicians who used it prior to the COVID-19 public health emergency in 2018, though it is down from the 79% of doctors using telehealth in 2020, according to the AMA Policy Research Perspectives report, “Patient-Facing Telehealth: Use Is Higher Than Pre-Pandemic But With Great Variation Across Physician Specialties” (PDF).
    • “Among the physicians surveyed in 2024, here is how many said their practices used telehealth for these services:
      • “52.5%—managed patients with chronic disease.
      • “48.5%—diagnosed or treated patients.
      • “40.3%—provided care to patients with acute disease.
      • “25%—provided preventive care.
    • “However, the ownership of the practice a physician was a part of appeared to have an impact on those numbers. Physicians in hospital-owned practices were more likely to report using telehealth than physicians who were part of a private practice.”  
  • Beckers Hospital Review informs us,
    • “Chesterfield, Mo.-based Mercy Health recorded an operating income of $70.2 million (2.6% operating margin) in the first quarter of fiscal 2026, up from an operating loss of $7.5 million (-0.3% margin) during the same period last year. 
    • “Mercy reported total operating revenue of $2.7 billion for the three months ended Sept. 30, up from $2.5 billion during the same period last year. Patient service revenue totaled $2.4 billion, up from $2.2 billion. Capitation revenue was $150.5 million, up from $141.3 million.”
  • and
    • “Seven hundred fifty-six rural U.S. hospitals are at risk of closure due to financial problems, with more than 40% of those hospitals at immediate risk of closure.
    • “The counts are drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through December 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure.” 
  • Fierce Pharma points out,
    • “Following a feud with activist investor Deep Track Capital in the first half of 2025, vaccine developer Dynavax Technologies has rounded out the year by agreeing to sell itself to France’s Sanofi.
    • “To get its hands on the Emeryville, California-based company and its approved adult hepatitis B vaccine Heplisav-B, Sanofi will pay $15.50 per Dynavax share in cash, which works out to a total deal value of roughly $2.2 billion, the French pharma said in a Dec. 24 press release.
    • “The acquisition, which is expected to close in 2026’s first quarter, also grants Sanofi access to Dynavax’s promising shingles prophylactic Z-1018, which is currently in phase 1/2 testing and could eventually challenge GSK’s incumbent shot Shingrix, if approved.”

In notable death news,

  • The Wall Street Journal reports,
    • “Joel F. Habener, a Harvard University academic whose research paved the way for revolutionary weight-loss drugs Ozempic, Mounjaro and others, which analysts forecast will be the biggest blockbusters in pharmaceutical history, died Sunday in Newton, Mass. He was 88.
    • “Eileen Martin, a friend of Habener’s, said he died peacefully at home. She didn’t give a cause.
    • “Habener led research that discovered a hormone dubbed GLP-1. The hormone regulates blood sugar levels and would later become the key ingredient in Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro—drugs that proved a major advance in diabetes treatment and so effective at regulating appetite that people who take them have called them miracle cures for obesity. Others taking the drugs say they cure addictions to nicotine, alcohol and gambling.”
  • RIP 

Weekend update

David Ermer–Congress, FDA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Congress is out of session again this week. The House of Representatives begins its 2026 session on January 6 while the Senate begins its 2026 session on January 5.
  • The American Bazaar tells us,
    • “Around 25,000 people have expressed interest in joining the “Tech Force,” a cadre of engineers to be hired by the Trump administration as it looks to install staff with artificial intelligence expertise in federal roles.
    • “The Trump administration will use that list to recruit software and data engineers, in addition to other tech roles, said Scott Kupor, director of the U.S. Office of Personnel Management, in a post on X. The 25,000 figure has been provided by a senior Trump administration official, according to a Reuters report.”
  • Beckers Hospital Review informs us,
    • “The Department of Homeland Security will replace the random lottery used to select H-1B visa recipients with a system that gives greater weight to applicants with higher skills.”
    • The article lets us know five things about this change.

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “It’s been a long time coming: Four years after Omeros came up short in its bid to gain an FDA approval for stem cell transplant drug narsoplimab, the Seattle biotech has finally scored its long-awaited nod.
    • “With a Christmas Eve thumbs-up for narsoplimab, the FDA has delivered Omeros its first U.S. approval in its 31 years. Taking on the commercial name Yartemlea, it also becomes the first treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The first-in-class lectin pathway inhibitor is for patients age 2 and older.
    • By selectively inhibiting MASP-2, which is the effector enzyme of the lectin pathway, Yartemlea blocks activation while preserving complement functions important for host defense.”

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

  • The Washington Post reports,
    • “When Marc and Cristina Easton’s son was diagnosed with autism at 20 months, the Baltimore couple left the doctor’s appointment in confusion. Their toddler — who was very social — didn’t resemble the picture of the condition they thought they knew. And the specialists could offer little clarity about why or what lay ahead.
    • “It wasn’t until four years after their child’s diagnosis that the Eastons finally began to get answers that offered them a glimmer of understanding. This summer, a team from Princeton and the Flatiron Institute released a paper showing evidence for four distinct autism phenotypes, each defined by its own constellation of behaviors and genetic traits. The dense, data-heavy paper was published with little fanfare. But to the Eastons, who are among the thousands of families who volunteered their medical information for the study, the findings felt seismic.
    • “This idea that we’re seeing not one but many stories of autism made a lot of sense to me,” Cristina said.”
  • The New York Times relates,
    • “The egg has become a dominant source of anxiety for many women. Human eggs are finite, declining in both quality and quantity with age. In a woman’s 30s, this starts to make it harder to get pregnant, and by menopause, a woman is without functional eggs. Growing awareness of this reproductive reality has led to a surge in egg freezing, as women aim to preserve the vitality of their younger eggs.
    • “But there’s more to infertility than old eggs. Recent research is bringing greater attention to the ovaries.
    • ‘An expanding body of evidence suggests that the age of an ovary, not just the eggs it contains, is important to reproduction and healthy aging. That includes the cells and tissues that make up the environment around a woman’s eggs, such as support cells, nerves and connective tissue.
    • “The tissues surrounding the follicles — fluid-filled sacs that contain an immature egg — can change with age, even becoming fibrotic. Research has shown that this can harm the quality of eggs, reduce the number that mature each month and block ovulation. Fibrosis is common in many aging organs as thick, scarlike tissue builds up. But it occurs decades earlier in the ovaries.”
  • The Wall Street Journal lets us know,
    • “Approved by the Food and Drug Administration decades ago for seizures and nerve pain from shingles, gabapentin is now the seventh-most widely prescribed drug in the U.S., according to the Iqvia Institute for Human Data Science. About 15.5 million people were prescribed gabapentin in 2024, according to an analysis by Centers for Disease Control and Prevention researchers. 
    • “Studies show that most of the prescriptions are written to treat conditions that it wasn’t approved for—a practice that is legal and common, but means the FDA hasn’t vetted its risks and benefits for those purposes.
    • “Some doctors say gabapentin can be helpful for certain types of neuropathic pain, a condition resulting from nerve damage. But doctors also give it to patients with other types of chronic pain, anxiety, migraines, insomnia, distorted sense of smell and hot flashes in menopause. Veterinarians dispense it to calm or treat pain in cats and dogs.
    • “A growing body of research shows it isn’t as safe or effective as doctors have long thought. Gabapentin has been associated in studies with greater risk of dementia, suicidal behavior, severe breathing problems for people who have lung disease, and edema, in addition to well-known side effects like dizziness.
    • “A study published this year found giving gabapentin to surgery patients didn’t reduce complications or get them out of the hospital any faster, and more of them reported pain four months after surgery. Doctors for years had touted gabapentin as a way to use fewer opioids. 
    • ‘While the medical establishment has mostly maintained that gabapentin isn’t habit-forming, some patients have reported debilitating adverse effects when they try to taper off it. They say the withdrawal symptoms make it clear to them they have developed a dependence to the drug taking it as prescribed.”
  • and
    • summarizes “The Future of Everything’s top stories of the year, including a formula for aging, fruit-picking robots and the car of the future.”
      • “This longevity doctor has a formula for aging better. Dr. Eric Topol’s research suggests lifestyle impacts longevity more than genes. The cardiologist believes more people can become “super agers” by embracing regular exercise and digital health technology.”
      • “Inflammaging” leads to cancer, but allergy drugs could help fight it. Dr. Miriam Merad is testing whether allergy drugs and other seemingly unlikely medications can help reduce chronic inflammation—or inflammaging—and thereby slow cancer in older patients.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Mail-order pharmacies filled just 9% of Medicare prescriptions in the three-year period examined by the Journal, but accounted for 37% of the excess dispensing, the analysis showed. Such pharmacies often send 90-day refills automatically when patients near the end of their earlier supplies.” * * *
    • “The Journal’s analysis counted as excess only dispensed prescription drugs that exceeded a month’s supply over up to three years’ worth of prescriptions.” * * *
    • “The Journal analysis is based on Medicare prescription records accessed under a research agreement with the federal government. The records include details of each individual prescription for more than 50 million Medicare recipients between 2021 and 2023, but don’t identify individuals. 
    • “Doctors and patients said such earlier-refilling practices aren’t limited to Medicare patients, and that it also happens with people covered by employer-sponsored plans. The Journal analysis doesn’t cover those private plans.”
  • Beckers Payer Issues identifies six insurer moves in 2025 that signal a heightened PBM focus.
  • Fierce Healthcare offers a 2026 outlook based on parting thoughts from dozens of healthcare CEOs retired in 2025.
  • HR Dive shares its “top 10 learning stories of 2025. Workers sounded off about the need for more training and just how great a role the onboarding experience plays in their retention.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity law enforcement front,

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “The National Institute of Standards and Technology announced that it will partner with The MITRE Corporation on a $20 million project to stand up two new research centers focused on artificial intelligence, including how the technology may impact cybersecurity for U.S. critical infrastructure.
    • “On Monday [December 22], the agency said one center will focus on advanced manufacturing while the second — the AI Economic Security Center to Secure U.S. Critical Infrastructure from Cyberthreats — will focus more directly on how industries that provide water, electricity, internet and other essential services can protect and maintain services in the face of AI-enabled threats. According to NIST, the centers will “drive the development and adoption” of AI-driven tools, including agentic AI solutions.
    • “The centers will develop the technology evaluations and advancements that are necessary to effectively protect U.S. dominance in AI innovation, address threats from adversaries’ use of AI, and reduce risks from reliance on insecure AI,” spokesperson Jennifer Huergo wrote in an agency release.
  • Federal News Network interviewed “a panel of former federal executives for their opinions about 2025 and what federal IT and acquisition storylines stood out over the last 12 months.”
  • Security Week tells us,
    • “The US Justice Department announced on Monday [December 22] the seizure of a web domain and a password database used by a cybercrime group to steal millions of dollars from bank accounts.
    • “According to the DOJ, the seized domain, web3adspanels.org, hosted a backend web panel used by the cybercriminals to store and manipulate thousands of stolen bank login credentials.
    • The threat actor conducted a massive bank account takeover scheme that involved malicious ads on search engines such as Google and Bing in an effort to lure users to fake bank websites.
    • “These phishing sites tricked victims into handing over their login credentials, which the cybercriminals could then use to access and drain their bank accounts.
    • “The FBI has identified nearly 20 victims in the US, including two companies, and has determined that the cybercriminals attempted to steal roughly $28 million, with the actual losses estimated at approximately $14.6 million.” 
  • Bleeping Computer informs us,
    • “An Interpol-coordinated initiative called Operation Sentinel led to the arrest of 574 individuals and the recovery of $3 million linked to business email compromise, extortion, and ransomware incidents.
    • “Between October 27 and November 27, the investigation, which involved law enforcement in 19 countries, took down more than 6,000 malicious links and decrypted six distinct ransomware variants.
    • “Interpol says that the cybercrime cases investigated are connected to more than $21 million in financial losses.”

From the cybersecurity breaches and vulnerabilities front,

  • Cybersecurity Dive reports,
    • “WatchGuard warns that a critical vulnerability in its Firebox devices is facing exploitation as part of a campaign targeting edge devices, according to an advisory from the company. 
    • “The flaw, tracked as CVE-2025-14733, involves an out-of-bounds write vulnerability in the Fireware OS internet key exchange daemon process. An unauthenticated attacker can achieve remote code execution. 
    • “WatchGuard said it discovered the flaw through an internal process and issued a patch on Thursday. 
    • “Since the fix became available, our partners and end users have been actively patching affected Firebox appliances,” a WatchGuard spokesperson told Cybersecurity Dive. “We continue to strongly encourage timely patching as a core best practice in security hygiene.”
  • Security Week shares information about the Watchguard patch.
  • Dark Reading points out,
    • “Much has been said about IT worker scams in the last few years, but it’s not every day that we get a glimpse into how pervasive the issue has become. 
    • “Stephen Schmidt, senior vice president and chief security officer at Amazon, wrote on LinkedIn over the weekend that the company has prevented “more than 1,800 suspected DPRK operatives from joining [Amazon] since April 2024, and we’ve detected 27% more DPRK-affiliated applications quarter-over-quarter this year.” 
    • “IT worker scams involve operatives working as part of or on behalf of a government try to gain remote IT employment. It is most often associated with North Korea (DPRK), but that’s not the only entity engaging in this practice. While one primary goal may be the worker gaining a foothold in a network for espionage purposes or for sensitive IP theft (and these things do happen), Schmidt, who wrote about North Korean worker scams specifically, highlighted another reason: “Their objective is typically straightforward: get hired, get paid, and funnel wages back to fund the regime’s weapons programs,” he wrote.
  • The Wall Street Journal relates,
    • “AI is making cybercriminals more efficient, enabling them to scale up operations and create more targeted and convincing scams.
    • “Thanks to AI, criminals are getting better at finding targets—for example, by scanning social media to identify people going through big life changes.
    • “Most experts don’t think fully autonomous AI cyberattacks are possible yet in the real world, but research has shown that AI is capable of planning and carrying out an attack on its own in a lab.”
  •  Per SC Media,
    • “A series of campaigns were observed targeting the financial sector across multiple continents worldwide — attacks that exhibited the tradecraft of North Korean-affiliated threat actors.
    • “In a Dec. 18 white paper, Darktrace researchers said the attacks leveraged advanced social engineering focused on job hunters, spear-phishing, React2Shell exploitation, and a new Beavertail malware variant.
    • “While the initial access vector remains unknown, Darktrace said evidence suggests it originated from a malicious npm package hosted on GitHub or GitLab — behavior that aligns with the Lazarus Group’s history of exploiting supply-chain vulnerabilities.
    • “According to Darktrace, the attackers used Beavertail for initial credential theft, followed by heavily obfuscated Python scripts and Tsunami modules, hallmarks of a “well-resourced adversary.”
  • Cyber Insider adds,
    • “A malicious NPM package masquerading as a WhatsApp API library has been discovered exfiltrating users’ messages, credentials, contacts, and media, all while delivering fully functional code.
    • “The package, named lotusbail, had been available on the NPM registry for over six months, amassing more than 56,000 downloads before its true purpose came to light.
    • “The discovery was made by Koi Security, whose researchers published a detailed technical report over the weekend, outlining the package’s behavior. The threat actor behind lotusbail cloned the legitimate @whiskeysockets/baileys WhatsApp Web API library and inserted advanced malware designed to siphon off sensitive user data during normal operation.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • A Cybersecurity and Infrastructure Security Agency program that warns organizations about imminent ransomware attacks has suffered a major setback after its lead staffer left the agency rather than take a forced reassignment.
    • David Stern, the driving force behind CISA’s Pre-Ransomware Notification Initiative (PRNI) — through which the agency alerts organizations that ransomware actors are preparing to encrypt or steal their data — resigned on Dec. 19, according to four people familiar with the matter. The Department of Homeland Security had ordered Stern to take a job at the Federal Emergency Management Agency in Boston or quit, and Stern chose the latter, three of the people said. * * *
    • “The fate of the warning initiative is now unclear. In a statement, CISA Director of Public Affairs Marci McCarthy said the program “has not stopped and continues to operate as a key element in CISA’s efforts to defeat ransomware attacks.” One person familiar with the matter said the agency is preparing several staffers to take over for Stern. But others said the program relied heavily on Stern’s trusted relationships with the organizations that alert CISA to pending ransomware attacks.”
  • InfoSecurity Magazine explores this year’s top ransomware trends.
  • The HIPAA Journal tells us,
    • “Madison, WI-based ARC Community Services, a provider of behavioral health, substance use disorder treatment, and support services to women and children, has experienced a ransomware attack involving the theft of sensitive data from its network.” The attack occurred in November 2024.
  • CSO informs us,
    • “A recent upgrade to the RansomHouse ransomware operation has added new concerns for enterprise defenders, introducing a multi-layered encryption update to the group’s double-extortion RaaS model.
    • “Also tracked under the cluster Jolly Scorpius, the ransomware gang has transitioned from a simple, single-phase encryption routine to a multi-layered dual-key encryption architecture that increases the complexity of its extortion operations.
    • “Detailed by Palo Alto Networks’ threat intelligence team, the update raises the bar for recovery once systems are compromised. The change affects how files are processed and encrypted during an attack, complicating analysis and limiting defenders’ ability to recover data without paying a ransom.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • Artificial-intelligence software company ServiceNow NOW agreed to acquire cybersecurity startup Armis for about $7.75 billion in cash in a move intended to take advantage of growing demand for AI security.
    • Armis recently raised $435 million in a funding round that valued the company at $6.1 billion, and it had been planning for an initial public offering at the end of 2026 or early 2027.
    • ServiceNow said on Tuesday that the acquisition would triple its market opportunity for security and risk solutions and entrench its position in the market for securing AI technology.
    • The increasing integration of AI tools into business workflows has raised worries that companies could become more vulnerable to cyberattacks and hacks.
  • Cyberscoop lets us know,
    • “How to determine if agentic AI browsers are safe enough for your enterprise. Automation is transforming web browsing, enabling AI agents to perform tasks once handled by humans. Yet with greater convenience comes a complex security landscape that enterprises can’t afford to ignore.”
  • Federal News Network discusses “The next cyber battlefield: Preparing federal networks for autonomous malware.”
    • “Recent research from Google’s Threat Intelligence Group has drawn new attention to a long-standing question in cybersecurity: How close are we to malware that can truly think and adapt on its own?
    • “Earlier this month, Google disclosed five experimental code families, including PROMPTFLUX and PROMPTSTEAL, that used large language models (LLMs) during execution to generate commands, rewrite portions of their own code, and adapt to their environment.
    • “While these findings are concerning, it’s important to note that “autonomous” malware is still in the early stages. But that’s precisely the point. Even in this primitive form, these early samples show how the threat landscape is rapidly evolving. Federal agencies now have a narrow window to prepare before those capabilities mature into operational threats.
    • “Autonomous malware represents a fundamental shift in cybersecurity, as this malicious code can reason about its surroundings, make tactical decisions, and evolve its behavior in real time. For federal networks built on complex systems and strict change-control policies, that evolution could eventually collapse traditional defense timelines and upend response models.”
  • Per a CISA news release,
    • “NIST and CISA’s draft Interagency Report Protecting Tokens and Assertions from Forgery, Theft, and Misuse is now available for public comment through January 30, 2026. This report is in response to Sustaining Select Efforts to Strengthen the Nation’s Cybersecurity and Amending Executive Order 13694 and Executive Order 14144, providing implementation guidance to help federal agencies and cloud service providers (CSPs) protect identity tokens and assertions from forgery, theft, and misuse.
    • “This report emphasizes the need for CSPs and cloud consumers, including government agencies, to better define their respective roles and responsibilities in managing identity and access management (IAM) controls in cloud environments. It establishes principles for both CSPs and cloud consumers, calling on CSPs to apply Secure by Designbest practices, and to prioritize transparency, configurability, and interoperability—empowering cloud consumers to better defend their diverse environments. It also calls upon government agencies to understand the architecture and deployment models of their procured CSPs to ensure proper alignment with risk posture and threat environment. 
    • “Comments on the report may be submitted to iam@list.nist.gov. Please visit NIST’s site for more information.” 
  • Per Dark Reading,
    • “As More Coders Adopt AI Agents, Security Pitfalls Lurk in 2026. Developers are leaning more heavily on AI for code generation, but in 2026, the development pipeline and security need to be prioritized.”
  • Here is a link to Dark Reading’s CISO Corner.