Tuesday report

FDA

Tuesday report

David Ermer–CDC, Congress, Electronic health records, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Tomorrow, the House of Representatives will vote on the appropriations bill that funds the FEHB and PSHB, among other programs, H.R. 7006 – Financial Services and General Government and National Security, Department of State, and Related Programs Appropriations Act, 2026
  • Beckers Hospital Review tells us whether the ACA healthcare premium subsidies stand.
  • Fierce Healthcare adds,
    • “The Trump administration has released a new update on enrollment on the Affordable Care Act’s exchanges, with signups lagging notably behind figures for the 2025 plan year.
    • “Per the latest snapshot report, nearly 22.8 million people have signed up for coverage across the exchanges through Jan. 3. By comparison, 23.6 million people had enrolled in ACA plans through Jan. 4, 2025, according to a report from a year ago.
    • “Of that total, the Centers for Medicare & Medicaid Services said 2.8 million individuals are new enrollees, while nearly 20 million are returning customers. Close to 15.6 million people signed up for coverage through Healthcare.gov, and 7.2 million used a state-based exchange, according to the report.
  • Beckers Payer Issues provides us with eleven No Surprises Act updates.
  • BenefitsLink calls our attention to a November 2025 IRS notice that provides for inflation adjustments to qualifying payment amounts issued in 2026 under the No Surprises Act. According to BenefitsLink, the notice was not well publicized.
  • Milliman assesses “Medicare drug price negotiation: Navigating the next wave of maximum fair prices.”
  • BioPharma Dive adds,
    • AbbVie is the latest among more than a dozen of the world’s largest drugmakers to sign a drug pricing deal with the White House, announcing late Monday a deal to invest $100 billion in U.S. pharmaceutical research and manufacturing and lower some product costs in return for tariff relief. 
    • As with the many other deals revealed between the Trump administration and large pharma companies, the agreement is short on details as well as its potential impact on AbbVie’s earnings. AbbVie only said that it will provide “low prices” to Medicaid and boost efforts to sell through a government portal widely used medicines like Humira, Alphagan, Combigan and Synthroid — all of which are off-patent and face competition from lower-cost biosimilars or generics. 
  • Per an HHS news release,
    • The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) today announced the appointment of two new members to the CDC Advisory Committee on Immunization Practices (ACIP). These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to transparency, gold standard science, and diverse expertise in guiding the nation’s immunization policies. In June 2025, Secretary Kennedy reconstituted ACIP to restore public trust in vaccines.
    • The new members are Adam Urato, MD, and Kimberly Biss, MD.
  • MedPage Today offers backgrounds on the new members.
  • Federal News Network notes that “A sea of challenges opens up with 105,000 feds retiring.”
    • “The one-year drop in the number of GS-14s and GS-15s across government is causing some to be concerned about the future of federal management.”

From the Food and Drug Administration front,

  • MedTech Dive points out,
    • “Medtronic said Monday it received 510(k) clearance from the Food and Drug Administration for an app to connect its smart insulin pens with a glucose sensor made by Abbott.
    • “The app, called MiniMed Go, provides alerts for missed insulin doses, a dose calculator and guidance on what to do if a person misses a dose. It also includes software reporting for providers.
    • “The pairing is part of a partnership Medtronic struck in 2024 for Abbott to make an integrated continuous glucose monitor sold exclusively by Medtronic.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The five-year survival rate for all cancers in the U.S. has reached 70% for the first time, according to a report published Jan. 13 by the American Cancer Society. The study analyzed diagnosed cases of cancer in the U.S. from 2015-2021. Among the findings, the study said that since the mid-1990s, there have been notable gains in the survival rates for more fatal cancers, such as myeloma (from 32% to 62%), liver (7% to 22%) and lung cancers (15% to 28%). The cancer mortality rate declined by a total of 34% since peaking in 1991, averting 4.8 million deaths since then.”
  • and
    • “A study released Jan. 12 by the Journal of the American College of Cardiology analyzed the current state of heart health in the U.S., highlighting the burden of disease, quality of care and mortality trends of risk factors and conditions that can lead to heart disease. The study found no change in the prevalence of hypertension among U.S. adults from 2009-2023 but found that hypertension-related cardiovascular deaths nearly doubled from 23 per 100,000 in 2000 to 43 per 100,000 in 2019. The prevalence of diabetes in U.S. adults increased from 11.9% in 2009-2010 to 14.1% in 2021-2023. Deaths related to type 2 diabetes increased from 30.4 per 100,000 adults in 2009 to 54 per 100,000 adults in 2023. The study analyzed other risk factors and conditions such as obesity, cigarette smoking and stroke, among others.”
  • STAT News adds,
    • “46% of U.S. counties don’t have a cardiologist. ARPA-H’s new agentic AI program could bring them specialized care.”
      • “The Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) program will support the development of Food and Drug Administration-authorized full-stack solutions that use agentic artificial intelligence to autonomously provide specialty care for every American living with advanced heart disease.”
  • The Washington Post explains how to know when to keep your kids out of school.
  • Per Genetic Engineering and BioTechnology News,
    • “Tahoe Therapeutics, Arc Institute, and Biohub have each made a multi-million dollar commitment to fill the massive data gap for virtual cell models. The teams exclusively told GEN Edge that more than 120 million single cell data points across 225,0000 perturbations will be generated using Tahoe’s Mosaic technology for mapping how drug molecules interact with biology.
    • “All three organizations lead a field that builds AI models trained on transcriptome data to predict how cell gene expression changes with cell states. In therapeutics, these virtual cells could gleam insight into new drugs capable of shifting cells from “diseased” to “healthy” with fewer off target effects.” 

From the J.P. Morgan Healthcare Conference,

  • Healthcare Dive reports
    • “JPM26: Dr. Oz, CMS leaders make their pitch to hospitals, payers on Trump admin healthcare policies.
  • and
    • “JPM26: CommonSpirit CEO teases new divestures, outlines AI wins and pitfalls”
  • Fierce Pharma offers a potpourri of biopharma stories from day 2.
  • STAT News adds,
    • It will be hard for OpenEvidence to top its 2025. The company announced nearly $500 million in funding last year and seemingly overnight became a go-to tool in the medical profession. A slide during the company’s Monday JPM presentation claims that queries to the company’s clinical evidence chatbot grew from 2.6 million in 2024 to 17.9 million in December 2025, with well over 100 million queries for the year.
    • “The company also revealed it will be launching “medical super-intelligence.” What does that mean? Katie Palmer explains in a new story.”

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

  • Beckers Hospital Review reports,
    • San Antonio-based University Health is investing $1.7 billion in a five-year expansion, including two new community hospitals and two multispecialty clinics.
  • and
    • “Skilled nursing facility operating capacity dropped by 5% in the U.S. between 2019 and 2024, according to a study published Jan. 12 in JAMA Internal Medicine.” 
  • STAT New relates,
    • “Illumina became a genomics juggernaut by developing machines that could read large amounts of DNA accurately and quickly. But the company’s betting the next phase of its growth will be accelerated by helping customers better understand genetic data and apply it to drug development.
    • “The San Diego firm took a step in that direction on Tuesday, when it unveiled what it says will be the world’s largest dataset of its kind, the Billion Cell Atlas. The atlas is based on the results of turning on or off genes across 200 cell lines, including lines used to study heart disease, neurologic disorders, immune conditions, and cancer.”
    • “Data on how these genetic perturbations affect cells could in principle help drug companies validate drug targets or create “virtual cells,” artificial intelligence-powered models of cell behavior. Thus far, Illumina has generated data from about 150 million cells and expects to reach a billion by the end of the year. The company’s already offering the atlas as a resource for pharmaceutical companies, with Merck, AstraZeneca, and Eli Lilly as its first customers. Several others have expressed interest, too, according to CEO Jacob Thaysen.”
  • Per MedCity News,
    • “If there’s any single company that understands or should understand the value of health data and its importance in patients’ lives, it’s Wisconsin-based EHR company Epic.
    • “And yet, while the company announced a whole host of future AI efforts last August, including a digital companion for patients called Emmie, it was OpenAI — which announced ChatGPT Health last week — that has actually given people the power to query their medical records and gain insights. Anthropic is announcing a similar capability for Pro and Max users of its Claude generative AI platform. Like Epic, other companies that demonstrated an understanding of that broad patient need also missed the boat.
    • “But in an interview on Friday, Epic’s chief medical officer pushed back on the notion that this was a “missed opportunity” for the EHR company.
    • “I would categorize it, instead of a missed opportunity, as thoughtfully developed over multiple years on top of other non-AI MyChart development and AI that’s actually going to be more thoughtful and tuned to your medical history and your personal medical care,” declared Dr. Jackie Gerhart, also a practicing family physician and vice president of clinical informatics.
    • “Gerhart, who has been with Epic for seven years, and another Epic R&D expert took some pains to describe how the company is developing the capabilities of Emmie, the digital concierge, deeply embedded within the EHR and able to not only handle simple queries like “create an exercise plan”or “explain my lab results” but also nudge you to do the things that you should do for better health.”

Monday report

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

From Washington, DC,

  • Federal News Network reports,
    • “Congressional appropriators are seeking less aggressive budget cuts for the IRS than what the Trump administration has proposed.
    • ‘Members of the House and Senate appropriations committees, in the latest package of spending bills for fiscal 2026, are also renewing efforts to shrink federal office space.
    • “Funding for the State Department remains relatively unchanged, despite a massive reorganization carried out last year.
    • “Meanwhile, lawmakers want agencies to use artificial intelligence tools to speed up the delivery of public-facing benefits and services.
  • Govexec adds,
    • “Lawmakers in Congress appear to have abandoned a plan to bar insurers participating in the federal government’s employer-sponsored health care program from covering gender affirming care for federal workers and their family members, though the development changes little, practically speaking.
    • ‘When the House first unveiled its draft of the fiscal 2026 Financial Services and General Government appropriations package last September, it included language barring federal funds being used to cover the cost of “surgical procedures or puberty blockers or hormone therapy” as part of gender affirming care under the Federal Employees Health Benefits Program.
    • “But a new version of the bill unveiled Sunday, negotiated with Senate appropriators and containing three of the 12 traditional appropriations packages, strikes that language, issuing no prohibition on gender-affirming care for FEHBP participants.
    • “Despite the recent reversal, the measure, if passed, on its own would not restore access to gender affirming care for federal workers and their families. That’s because the Office of Personnel Management last year instructed insurance carriers who participate in FEHBP to cease covering those treatments.”
  • Here is a link to the House Appropriations Committee’s January 11 news releases on these new appropriations bills.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services has released a request for information seeking input on replacing its Medicare claims processing system with a real-time, cloud-based platform. Under the program, called ClaimsCore, CMS is seeking vendors already capable of supporting more than 2 million active members on a single production instance and processing more than 100,000 claims per day. CMS said the program would provide faster, more transparent claims, strengthen fraud protection and provide near real-time explanations of benefits, among other improvements.” 

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.” * * *  
    • “Menkes disease is a neurodegenerative disorder caused by a genetic defect that impairs a child’s ability to absorb copper. The disease is characterized by seizures, failure to gain weight and grow, developmental delays, and intellectual disability. It leads to abnormalities of the vascular system, bladder, bowel, bones, muscles, and nervous system. Children with classical Menkes (90% of those with the disease) begin to develop symptoms in infancy and typically do not live past three years. It affects approximately one in every 100,000-250,000 live births worldwide and is more common in boys.”
  • and
    • “The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective treatments to patients sooner. 
    • “Bayesian methodologies help address two of the biggest problems of drug development: high costs and long timelines,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Providing clarity around modern statistical methods will help sponsors bring more cures and meaningful treatments to patients faster and more affordably.”
    • “Bayesian approaches use a different framework from traditional statistical approaches. In a Bayesian analysis, data from a study are combined with relevant prior information to form a new distribution that can be used for inference and to draw conclusions about safety and efficacy.” 

From the judicial front,

  • Bloomberg Law lets us know,
    • “The US Supreme Court rejected a case seeking to force health insurers to pay arbitration awards that medical providers win in disputes over surprise medical bills, ending a long-running fight for a pair of air ambulance companies.” * * *
    • “Courts have so far mostly ruled for insurers in determining that oversight of the process resides with the Department of Health and Human Services, though providers have notched a couple of victories in district court.
    • The petition sought the high court’s input on whether the law grants parties the private right to sue, as well as whether breaching the relevant plan terms constitutes an injury to an enrollee under the Employee Retirement Income Security Act.” * * *
    • “The case is Guardian Flight LLC v. Health Care Serv. Corp. , U.S., No. 25-441, decision issued 1/12/26.”
  • STAT News reports,
    • “The Trump administration has signaled plans to drop its appeal of a court order that blocked a pilot program from changing payment terms for a controversial federal drug discount program.
    • “In a Monday court document, the Department of Justice indicated talks are underway with the American Hospital Association and several hospital systems, which filed a lawsuit challenging a plan that allowed drug companies to pay rebates — instead of discounts — for some medicines purchased under the 340B Drug Pricing Program.
    • “The parties are engaged in discussions about returning the [rebate] approvals challenged in this litigation to the agency for reconsideration. The agency intends to resolve such proceedings promptly. Therefore, the parties do not believe that expediting this appeal is warranted at this time and plan to dismiss the appeal in short order,” the DOJ wrote.”
  • MedTech Dive informs us,
    • “Edwards Lifesciences said Friday it has dropped plans to acquire JenaValve Technology after a U.S. district court granted the Federal Trade Commission’s motion for an injunction blocking the transaction.
    • “Edwards said it disagrees with the ruling, in the U.S. District Court for the District of Columbia, and believes the acquisition would have been in the best interest of a large underserved group of patients.”

From the public health and medical / Rx research front

  • The Wall Street Journal reports,
    • “If everyone you know seems to have the flu, there is a reason for that: Influenza climbed to unusually high levels across the country, thanks to a flu strain that caught us off guard.
    • “There have already been an estimated 15 million cases of the flu, according to the Centers for Disease Control and Prevention, along with 180,000 hospitalizations and 7,400 deaths.
    • It is the worst flu season in recent years though numbers are starting to decline yet remain high. But there are two things making things easier for some folks.
    • One, we all became familiar with at-home rapid tests for Covid-19 during the pandemic so more people are comfortable taking such tests at home for influenza. This results in more timely diagnoses.
    • That makes it easier to take antivirals, which make people feel better sooner, provided they are started within two days of getting sick. While most people are familiar with Tamiflu (oseltamivir phosphate), there is another antiviral, Xofluza (baloxavir marboxil) making the rounds on social media.
  • The AP related last Friday,
    • “South Carolina’s measles outbreak exploded into one of the worst in the U.S., with state health officials confirming 99 new cases in the past three days. 
    • “The outbreak centered in Spartanburg County grew to 310 cases over the holidays, and spawned cases in North Carolina and Ohio among families who traveled to the outbreak area in the northwestern part of the state.
    • “State health officials acknowledged the spike in cases had been expected following holiday travel and family gatherings during the school break. A growing number of public exposures and low vaccination rates in the area are driving the surge, they said. As of Friday, 200 people were in quarantine and nine in isolation, state health department data shows.
    • “The number of those in quarantine does not reflect the number actually exposed,” said Dr. Linda Bell, who leads the state health department’s outbreak response. “An increasing number of public exposure sites are being identified with likely hundreds more people exposed who are not aware they should be in quarantine if they are not immune to measles.”
  • The American Medical Association lets us know what doctors wish their patients knew about donating blood.
    • “When caring for patients, physicians and other health professionals rely on blood donation to support care ranging from trauma response to cancer treatment. But ongoing blood shortages mean many hospitals and health systems struggle to keep an adequate supply on hand. With the need for donating blood rising during seasonal shortages or public health crises, a single donation of blood can help up to three people. Donating blood when you can is vital because maintaining an adequate blood supply is a shared responsibility that strengthens patient care across the country.”
  • The Washington Post informs us,
    • “An estimated quarter of traditional Medicare beneficiaries with dementia are prescribed risky, brain-altering drugs despite years of clinical guidelines cautioning against the practice, a new study shows.
    • “The drugs fall into five broad categories — including antidepressants, antipsychotics, antidepressants and barbiturates — that may leave older adults in a drowsy, confused fog that can make them less steady on their feet and more prone to falls. And while the study published Monday in JAMA found that overall prescriptions for these types of drugs for traditional Medicare beneficiaries fell from 2013 to 2021, their “potentially inappropriate” use was significantly higher for people who are cognitively impaired or have dementia compared to people whose cognition was normal.
  • Per Genetic Engineering and Biotechnology News,
    • “Many of us will recognize being in a situation where it’s really hard to get started on a task—whether it’s making a difficult phone call or preparing a presentation that’s stressful just to think about. We understand what needs to be done, yet taking that very first step feels surprisingly hard.
    • “When this difficulty becomes severe, it is known medically as avolition. People with avolition are not lazy or unaware. They know what they need to do, but their brains seem unable to push the “go” button. Avolition is commonly seen in conditions such as depression, schizophrenia, and Parkinson’s disease, and it can seriously disrupt a person’s ability to manage daily life and maintain social functions.
    • “Working with macaque monkeys trained to perform certain tasks, scientists at Kyoto University applied chemogenetics techniques to identify a pathway between the ventral striatum (VS) and ventral pallidum (VP) in the brain that functions as a “motivation brake,” suppressing this internal “go” button, particularly when facing stressful or unpleasant tasks. The results showed that chemogenetic suppression of this VS–VP pathway restored motivation in the animals under aversive conditions.
    • “The team, headed by Ken-ichi Amemori, PhD, an associate professor at the Institute for the Advanced Study of Human Biology (WPI-ASHBi), and colleagues, suggests that the discovery of this VS–VP motivation brake may shed light on conditions such as depression and schizophrenia, where severe loss of motivation is common, and point to interventional strategies.”

From the J.P. Morgan Healthcare Conference 2026,

  • Per BioPharma Dive,
    • “JPM26: US biotech’s ‘Sputnik moment,’ Pfizer’s obesity ambitions and Bristol Myers’ big year.
    • “Four recent deals fueled more angst about China’s biotech progress, while Pfizer, Bristol Myers and Sarepta all worked to appease jittery investors.”
  • Fierce Healthcare reports,
    • “Abridge is partnering with real-time health information network Availity to fire up AI-powered prior authorization, expanding the reach of real-time coverage approval to more providers.
    • “The two companies announced a partnership, timed to the annual J.P. Morgan Healthcare Conference, to scale up real-time prior authorization. The integration of the two companies’ technologies could significantly speed up prior auth, from months to minutes. The use of Abridge’s ambient AI and Availity’s data exchange tech can compress a weekslong process that occurs post-visit to one that happens in real-time during the patient exam.
    • “Rather than create disparate AI systems, Abridge and Availity decided to team up to share information between providers and health plans at the point of care, making the process of medical necessity review more efficient, the companies said in a press release.”
  • and
    • “Teladoc is improving its 24/7 virtual urgent care for health plans by upskilling providers through real-time specialist consultations and offering care for a broader set of conditions, the company announced at the 2026 J.P. Morgan Healthcare Conference.
    • “The company hopes to save health plans money by reducing the number of follow-up appointments a patient may need to have after a virtual urgent care visit. 
    • “Teladoc’s virtual urgent care, which has been operational for over 20 years, will now be treating back and joint pain, hair loss and sleep issues, in addition to acute conditions like colds, coughs and ear infections.” 
  • Fierce Pharma offers a potpourri of stories from day one of the conference.

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Boston Scientific said Monday it has agreed to acquire Valencia Technologies, a developer of treatments for bladder dysfunction, for an undisclosed sum.
    • “Valencia makes the eCoin tibial nerve stimulator, which received Food and Drug Administration approval in 2022 to treat urinary urge incontinence. The leadless device is implanted near the ankle.
    • “The deal will allow Boston Scientific to expand into a high-growth area that complements the company’s existing pelvic health product line, Meghan Scanlon, Boston Scientific’s president of urology, said in a statement.” 
  • Beckers Payers Issues points out,
    • Administration and automation are not the only AI use cases payers should be focused on this year, according to McKinsey Senior Partner Adi Kumar, who broke down his 2026 predictions for insurers in a Jan. 12 report.
      • “1. Payers are at a place to look beyond AI administrative use cases. Care management is one opportunity where payers can assert more control.
      • “2. Mr. Kumar said healthcare has been slow to reach a technological revolution, but payers can harness technology to better engage with consumers.
      • “3. The One Big Beautiful Bill Act will raise the bar for payer performance, affecting how much money insurers get from the federal level. Payer financials could either take a hit — hurting risk pools — or payers could play the “productivity game” to get ahead.
      • “4. Mr. Kumar encourages payer CEOs to consider what types of business they want to focus on as the line between payers, providers and services get more blurred.
      • “5. CEOs also need to think about productivity and “how to do more with less.”
  • BioPharma Dive calls attention to five questions facing biopharma this year.
    • “The biopharmaceutical sector finally regained its footing in 2025. Here are five issues that could determine whether the renewed optimism will carry over into the new year.”
  • Beckers Hospital Review relates,
    • “In recent years, a swell of states has adopted laws to lessen the requirements for foreign-trained physicians to join the U.S. workforce.  
    • “The laws aim to combat the nation’s growing physician shortage, which is becoming more urgent as patient acuity rises, more physicians approach retirement age and a plethora of other factors. One tactic to staunch the shortage is reducing or eliminating residency requirements for internationally trained medical school graduates to gain employment in the U.S.
    • “Eighteen states have laws allowing internationally trained physicians to gain full licensure, three states grant limited licensure, three other states have pending bills related to limited licensure and another six state legislatures are considering pathway bills in 2026.
    • “International medical graduates account for about one-fourth of physicians practicing in the U.S., according to the American Medical Association, which supports these pathway laws.” 

Weekend Update

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

From Washington, DC

  • Tomorrow, the Senate will take a final vote on H.R. 6938, Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026, which the House of Representatives already has passed. When as expected, the Senate passes this bill, Congress will have passed half of the twelve appropriations bills in regular order.
  • Roll Call offers more insights into the state of the appropriations process.
    • “The House, meanwhile, looks to move forward with a bundle of two more spending bills, including funding for the State Department, the Treasury and an assortment of related agencies including the White House itself.”
    • While the Senate has scheduled a recess for next week, “[t]he House is expected to be in session next week except for Jan. 19, which is Martin Luther King Jr. Day.”
  • Per a Senate news release,
    • “On Thursday, January 15, [at 10 am ET] the Senate Health, Education, Labor, and Pensions (HELP) Committee will vote on several bipartisan bills to improve American families’ health.
    • “The bills under consideration include:
      • “S. 1157, Women and Lung Cancer Research and Preventive Services Act
      • “S. 921, Tyler’s Law
      • “S. 2169, Rural Hospital Cybersecurity Enhancement Act
      • “S. 272, Protect Infant Formula from Contamination Act.” * * *
    • “Click here to watch live.”
  • Per a House news release,
    • “Ways and Means Committee Chairman Jason Smith (MO-08) and Energy and Commerce Committee Chairman Brett Guthrie (KY-02) announced the details for an upcoming hearing with five of the biggest health insurance company CEOs to answer questions on making health care more affordable for all Americans.” * * *
    • “The date of the hearing will be January 22, 2025, with the panel appearing before the House Committee on Energy and Commerce Subcommittee on Health in the morning, and the House Committee on Ways and Means in the afternoon. 
    • “Company CEOs in attendance will be UnitedHealth Group, CVS Health, Elevance Health, The Cigna Group, and Ascendiun (the parent company of Blue Shield of California).”
  • Govexec tells us,
    • “The Trump administration is bringing back an awards program for senior executives after canceling it for fiscal 2025. 
    • “In a Jan. 5 memo, Office of Personnel Management Director Scott Kupor asked agencies to nominate up to nine percent of their highest-ranking career employees for the fiscal 2026 presidential rank awards. The program was established in 1978 to honor civil servants who have exhibited consistent achievement.”
  • BioPharma Dive reports,
    • Johnson & Johnson on Thursday [January 8] became the latest pharmaceutical company to agree to “most favored nation” pricing in return for a reprieve on pharmaceutical tariffs. The company didn’t provide many specifics in its announcement. But it’ll participate in a government online channel for drug purchasing; enable U.S. patients to access drugs at comparable prices to what’s paid in foreign countries; and give the same prices to Medicaid, which already has best-price guarantees. J&J will also build a cell therapy plant in Pennsylvania and a facility in North Carolina as part of its $55 billion commitment to boost U.S. manufacturing capacity.

Frrom the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT). The agency’s more flexible approach has been, and is expected to continue to be, helpful in expediting product development and will help guide the FDA’s evaluation of development strategies in preparation for a Biologics License Application (BLA) submission.  
    • “Regulatory flexibility must be tailored for cell and gene therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “These are common-sense reforms that will address the unique characteristics of cell and gene therapies and foster more innovation.”
  • The Washington Post explains the problem that the FDA seeks to resolve.
    • “Genetic therapies could be used to treat hundreds of diseases. The path to patients is tricky.”
  • STAT News notes,
    • “Stoke Therapeutics and the Food and Drug Administration were unable to reach agreement on an expedited submission for the company’s severe epilepsy treatment, the company said Sunday. 
    • “Following a meeting in December, the FDA did not shut the door on Stoke’s request to submit zorevunersen, a treatment for Dravet syndrome, later this year, rather than wait for the completion of an ongoing Phase 3 study in the middle of 2027, Stoke CEO Ian Smith told STAT in an interview.
    • “Instead, regulators asked the company to submit more information, and further discussions are planned. Stoke expects to make a decision on a regulatory path for zorevunersen by the middle of the year.” 

From the public health and medical / Rx research front,

  • Medscape relates,
    • “Different subgroups of patients with adult-onset diabetes showed different rates of comorbidities and mortality outcomes. Patients with severe insulin-resistant diabetes (SIRD), a high-risk subtype, were most likely to have kidney, liver, and heart diseases despite having only mild hyperglycemia, and some of these conditions were present even before diabetes was diagnosed.”
  • Healio points out,
    • “Between 50% to 75% of children struggle with adhering to health care regimens.
    • “Rebecca Liu, a senior at UCLA, described her idea for a game that could educate children about their health and improve adherence.”
  • The Wall Street Journal considers,
    • “What Time Should You Wake Up? Probably Not 5 a.m.
    • “Sleep experts warn against rising too early if you’re not naturally a morning person, and provide tips for a better night’s sleep.” * * *
    • “Your ideal rise time is linked to your chronotype, your genetic predisposition to waking at a certain time. (If you need help understanding yours, take Breus’s quiz, which requests your name and email address.)”
  • MedPage Today reports,
    • “An immuno-oncology (IO) regimen for intermediate-stage hepatocellular carcinoma (HCC) significantly extended treatment benefit versus transarterial chemoembolization (TACE), according to an interim analysis of a randomized trial.
    • “Time to failure of treatment strategy (TTFS) increased from 9.5 months with TACE to 14.6 months with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin). Treatment-related adverse events (TRAEs), including grade ≥3 TRAEs, occurred more often with the systemic therapy, but no unexpected or excess fatal events occurred.
    • “The results provided justification to continue enrollment and follow-up to a second planned interim analysis later this year, reported Peter R. Galle, MD, of University Medical Center Mainz in Germany, at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.”

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

  • Modern Healthcare reports,
    • “The 44th annual J.P. Morgan Healthcare Conference kicks off Monday, drawing more than 8,000 healthcare executives and investors to San Francisco. 
    • “At a time of widespread uncertainty for the industry’s profit potential, companies will unpack their latest financial results while touting capital projects, technology advancements and merger and acquisition plans to private equity firms, venture capitalists and other potential investors. More than 500 public and private companies are expected to discuss a range of topics including artificial intelligence, biotechnology, personalized medicine, digital health, healthcare funding, regulation and glucagon-like peptide-1 drugs that treat diabetes and obesity.”
  • The Wall Street Journal adds,
    • “When Health Secretary Robert F. Kennedy Jr. released his MAHA Report in May, a who’s who of the wellness world convened at the White House for the occasion. There was the influential physician Mark Hyman, who co-founded the direct-to-consumer testing company Function Health, recently valued at $2.5 billion. Also in attendance: Alex Clark, the host of the popular Turning Point USA podcast “Culture Apothecary.” Longevity influencer Gary Brecka, who’d recently had Kennedy over to get intravenous drips and use Brecka’s hyperbaric chamber, was present, along with the “medfluencers” Dr. Will Cole and Dr. Paul Saladino.
    • “All of them support Kennedy’s ascent to the nation’s top health job. And all of them stand to gain from the spotlight he’s placed on alternative health. That’s because each of them has ties to the business of supplements, a $70 billion, lightly regulated U.S. market that could benefit from his support. On Brecka’s podcast, recorded after their wellness treatments, Kennedy vowed to end “the war on vitamins.”
  • Fierce Pharma lets us know,
    • As Novartis turns the calendar on a new year, the Swiss drugmaker is elaborating further on plans for the $23 billion U.S. investment it unveiled last April.
    • Next on the docket will be a new, 35,000-square-foot radioligand therapy (RLT) facility in Winter Park, Florida, Novartis reported Friday. 
    • Joining established plants in Novartis’ American RLT network in Indiana, New Jersey and California, the new facility will boost the company’s radiopharmaceutical manufacturing to “optimize the delivery” of the cutting-edge cancer treatments to patients across the southeastern United States, Novartis said in a Jan. 9 press release. The upcoming site is expected to come online by 2029, the company added. 
  • Buiness Insider relates,
    • “Anthropic is rolling out a major expansion of its healthcare and life-sciences offerings, as AI companies race to embed large language models more deeply into regulated medical workflows.
    • “The company on Sunday announced Claude for Healthcare, a product that allows healthcare providers, insurers, and consumers to use Claude for medical purposes through HIPAA-ready infrastructure. 
    • “The launch builds on Anthropic’s earlier release of Claude for Life Sciences, which focused on research and drug discovery, and reflects the company’s broader effort to position its AI models as practical tools for regulated industries.”

Notable Obituary

  • The New York Times reports,
    • “Dr. Joel Habener, an American endocrinologist who discovered GLP-1, the protein fragment that became the basis of Ozempic, Wegovy and other blockbuster weight-loss and diabetes drugs that are transforming 21st-century medicine, died on Dec. 28 in Newton, Mass. He was 88.
    • “His death, in a retirement community, was confirmed by his brother, Stephen, who said the cause was a heart attack.” * * *
    • “Dr. Habener’s discovery of GLP-1, in 1987, came about almost by accident. “It was a eureka moment,” he said in a 2023 interview, “which rarely happens in science.”
    • “He was a researcher at the time at Massachusetts General Hospital, where he arrived in 1971 and remained until his retirement in 2023.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Beckers Payer Issues tells us,
    • “CMS has become more aggressive with its rollout of new payment and care delivery models.
    • To provide healthcare leaders with an outlook for 2026, research firm ATI Advisory compiled observations from 2025 to gain a sense of CMS’ plans for its Innovation Center.” 
  • Modern Healthcare reports,
    • “Safety-net providers got a reprieve from a controversial plan to replace discounts with rebates under the 340B Drug Pricing Program, but they aren’t in the clear.
    • “The Health Resources and Services Administration intended to launch a pilot program this month that would allow nine pharmaceutical companies to give 340B providers rebates on 10 prescription drugs, rather than upfront discounts, for at least a year.”
    • “340B providers cried foul, and the American Hospital Association sued to block the initiative, which it contends would enrich drugmakers at its members’ expense. Last month, the U.S. District Court for the District of Maine directed HRSA to suspend the program while it considers the case. The U.S. Court of Appeals for the 1st Circuit upheld that preliminary injunction Wednesday.” * * *
    • “Yet even if the AHA wins the case, the rebates plan could resurface. 
    • “Separate court rulings last year affirmed that HRSA has the authority to institute rebates under 340B, so the agency could simply try another approach. “Congress clearly gave defendants that option,” Walker wrote.
    • “HRSA remains committed to the rebates pilot and other actions on 340B, and the pharmaceutical industry aims to do its part to fight back against the lawsuit and against what it views as a bloated program that has grown beyond its original scope. The Health and Human Services Department declined to comment on ongoing litigation.”
  • Per an NCQA news release,
    • “The National Committee for Quality Assurance (NCQA) today announced the appointment of Sarah E. Saxton, MBA, as Senior Vice President of Quality Services. Saxton brings more than 20 years of experience advancing quality, performance measurement, and large-scale transformation across public and private health systems.
    • “In this role, Saxton will lead NCQA’s Quality Solutions Group, driving research and implementation efforts that underpin NCQA’s evidence-based standards and performance measures. She will also deepen collaboration with federal agencies to advance initiatives that deliver measurable improvements in healthcare systems and patient outcomes.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “A biotechnology firm hatched by two prominent researchers publicly debuted on Friday, aiming to use a new regulatory framework to quickly develop many gene editing treatments for rare diseases.
    • “Called Aurora Therapeutics, the startup was co-founded by Nobel laureate Jennifer Doudna and genetic medicine expert Fyodor Urnov and seeded by Menlo Ventures. It intends to simultaneously work on multiple therapies for the same condition, each of which target different genetic mutations, and quickly advance them with the help of the Food and Drug Administration’s recently unveiled “plausible mechanism” pathway.“
  • Cardiovascular Business relates,
    • “AccurKardia, a New York-based medtech company, has received U.S. Food and Drug Administration (FDA) clearance for the latest version of its AccurECG Analysis Software, a fully automated platform that delivers rapid electrocardiogram (ECG) interpretations.
    • “AccurECG 2.0 was designed to interpret a total of 13 different rhythm classifications, including atrial fibrillation, atrial flutter and ventricular tachycardia. According to AccurKardia, it was developed to be used by cardiac monitoring companies, device makers, hospitals and independent diagnostic testing facilities alike. 
    • “AccurECG 2.0 was designed to be device agnostic, meaning these artificial intelligence (AI) algorithms can be utilized by a wide range of stakeholders. The software can interpret test results originating from patches or any other traditional ECG devices.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated 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.
    • “COVID-19
      • “COVID-19 activity is low but increasing nationally.
    • “Influenza
      • “Seasonal influenza activity remains elevated across the country.
      • “Although some indicators have decreased or remained stable this week compared to last, this could be due to changes in the number of people seeking healthcare, testing or reporting during the holidays rather than an indication that influenza activity has peaked. The country is still experiencing elevated influenza activity and elevated influenza activity is expected to continue for several more weeks.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • “RSV activity is elevated in many areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains suboptimal for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • Beckers Clinical Leadership offers “four things to know from the CDC’s latest FluView report.”
    • Flu positivity dipped but remains high.
    • Pediatric deaths increased.
    • A(H3N2) continues to dominate.
    • Hospitalizations continue to climb.
  • and
    • “The annual number of deaths in the U.S. is projected to exceed the annual number of births beginning in 2030, according to a January report from the Congressional Budget Office.
    • “The projections are based on existing laws and policies as of Sept. 30, as well as recent demographic trends, and serve as a benchmark for assessing how potential legislation could affect the size and structure of the U.S. population.” * * *
    • “The population is expected to become older on average between 2026 and 2056. The cohort of Americans 65 and older is expected to grow through 2036 at an annual average rate of 1.6% — faster than the average growth rates projected for younger cohorts. The group ages 24 and younger is expected to decrease in each of the next 30 years.
    • “An older population presents a dual challenge for hospitals and health systems: increasing demand for more complex care and exacerbating workforce shortages as more Americans retire.
    • “The aging trend is driven by longer life expectancies and baby boomers reaching age 65 or older by 2030, according to Maria Ansari, MD, co-CEO of The Permanente Federation and CEO of three of Oakland, Calif.-based Kaiser Permanente’s medical groups.”
  • The American Hospital Association News lets us know,
    • “A study published Jan. 7 by the University of Minnesota Rural Health Research Center examined the availability of hospital-based obstetric services in the U.S. by county from 2010-2023. It found 293 counties (8.6%) nationwide lost all hospital-based obstetric services during that period. Among those, 26 counties experienced a recent loss between 2022 and 2023, 21 of which are rural counties. Among the 148 rural counties with a town population of 10,000 or fewer people, 11% lost all hospital-based obstetric services from 2010-2023. Overall, 60% of rural counties and 38% of urban counties did not have any hospital-based obstetric services by 2023.” 
  • The University of Minnesota’s CIDRAP tells us,
    • “The influenza and tetanus, diphtheria, and pertussis (whooping cough; Tdap) vaccines are an estimated 69.7% and 88.6% effective against flu- or pertussis-related hospitalizations or emergency department (ED) visits, respectively, among the infants of vaccinated mothers, although with considerable uncertainty, per an observational study published yesterday in JAMA Network Open.”
  • Per HCPLive,
    • “Exercise is as effective as psychological therapy in alleviating depressive symptoms, with no significant difference in outcomes.
    • “Moderate-intensity exercise, especially between 13 and 36 sessions, provides the greatest benefit for reducing depressive symptoms.
    • “Many trials exhibited biases, emphasizing the need for more high-quality, large-scale studies with clinically diagnosed participants.
    • “The study suggests exercise could complement or serve as an alternative to traditional depression treatments, though further research is necessary.”
  • Per the Genetic Engineering and BioTechnology News,
    • “Some parts of the body can recover from injury fairly rapidly. The cornea, for example, can heal from minor scratches within a single day. The human brain, however, is not one of these fast-healing tissues or organs. Adult brain cells are stable and last for a lifetime— barring trauma or disease—while some cells lining the gut last only five days and must be continually replaced.
    • “Scientists would like to use stem cell therapy to boost the brain’s ability to regenerate following damage resulting from concussion or stroke. To date, such treatments have been stymied due to injury-related changes in the brain, as well as with difficulties integrating regenerated cells into existing brain circuits to restore functions such as memory retention or motor skills.
    • “Scientists headed by a team at Sanford Burnham Prebys Medical Discovery Institute and Duke-National University of Singapore (NUS) Medical School now report the results of testing a regenerative therapy derived from human stem cells. Their studies showed that when transplanted into mice, the cells matured, integrated into existing circuits and restored function. By tracing the cells and sequencing their gene expression patterns, the researchers also revealed how transplanted cells find where they need to go and form connections with the nervous system. The studies showed that the cells contain their own intrinsic codes for navigation, and once they become neurons, this code instructs the cell to send its axons to a specific area of the brain.
    • “Headed by Su-Chun Zhang, MD, PhD, the Jeanne and Gary Herberger Leadership chair in neuroscience and the director of and professor in the Center for Neurologic Diseases at Sanford Burnham, the researchers reported their findings in Cell Stem Cell, in a paper titled “Transcriptional code for circuit integration in the injured brain by transplanted human neurons.” In their paper the team concluded, “Our finding opens a promising strategy for treating neurological diseases through promoting regeneration and neural transplantation.”

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

  • The Wall Street Journal reports,
    • “Merck MRK is in talks to acquire Revolution Medicines in a deal that could value it at around $30 billion, according to people familiar with the matter. 
    • “A deal for the cancer-drug biotech could come as soon as later this month, the people said, cautioning the talks could still fall apart or another suitor could prevail. 
    • “Merck has been discussing a deal valued between $28 billion and $32 billion, the people added.” * * * 
    • “Revolution is developing drugs that target a molecular driver of cancers known as RAS. Revolution’s experimental drugs seek to block the driver, thereby thwarting cancers including lung, pancreatic and colon. 
    • “If it proves to work safely, the pancreatic-cancer drug candidate could generate $10 billion in 2035 worldwide sales, Mizuho Securities analysts estimate.” 
  • Digital Commerce 360 informs us,
    • “CVS Health has outlined a broad digital and artificial intelligence (AI) strategy aimed at simplifying health care delivery.
    • “The strategy deepens consumer engagement and supports multiyear earnings growth. It positions technology as a core driver of the company’s next phase rather than a back-office function.
    • “At its 2025 investor day in December, the health care and pharmacy company introduced what it described as an AI-native consumer engagement platform. It designed the platform to connect interactions across CVS Pharmacy, CVS Caremark, Aetna and its health care delivery businesses into a single digital interface. Executives said the company intends for the platform to reduce friction for consumers by navigating prescriptions, benefits, and care, while also improving operational efficiency across the enterprise.”
  • Per a LinkedIn post by a Memorial Sloan Kettering Cancer Center executive,
    • “Memorial Sloan Kettering Cancer Center has entered into a one-year trial partnership with OpenAI on its new HIPAA-compliant version of hashtag#ChatGPT, “ChatGPT Healthcare”. This collaboration is designed to accelerate responsible AI adoption at MSK by providing new a range of tools and access to expertise in support of our clinical, research, and operational workflows. As an early launch partner, we’re also looking forward to shared learning alongside peer institutions across the country. Importantly, this partnership reflects a strong, shared commitment to rigorous governance, privacy, and security. We see this as a meaningful opportunity not only to advance our own work, but also to help shape the broader conversation on how AI can thoughtfully and responsibly enhance cancer care and research.”
  • Fierce Healthcare points out,
    • “Pittsburgh-based insurer Highmark is further expanding its drug offerings through CivicaScript and leaning on biosimilars as pharmaceutical costs continue to rise for many.
    • “Highmark is a founding member of the drug company, which manufactures lower-cost alternatives to high-cost generic products. CivicaScript is a sister to Civica Rx, a drugmaker cofounded by health systems that makes key products for care facilities, which are often in short supply.
    • “The insurer first made abiraterone acetate, a drug for treating prostate cancer, available through CivicaScript in 2023, and found that members are saving $90 each month on average thanks to this partnership and its relationship with specialty pharmacies.
    • “Highmark said that more than 300 members are benefiting from the savings—across both individual and group customers, the plan has collectively saved $8 million.
    • “And as of September 2025, Highmark is now offering four additional CivicaScript products: dimethyl fumarate and dalfampridine, which are both used to treat multiple sclerosis; droxidopa, which is used for neurogenic orthostatic hypotension; and capecitabine, a cancer drug.”
  • Per MedTech Dive,
    • “Haemonetics will acquire Vivasure Medical, an Ireland-based firm that makes a patch device for percutaneous vessel closure, the companies announced Friday.
    • “Haemonetics will pay 100 million euros upfront ($116.3 million), or about 52 million euros when including the value of certain previous investments and loans. Vivasure will be able to get an additional 85 million euros if it meets certain sales growth and other milestones.
    • “The acquisition is expected to bolster Haemonetics’ presence in the large-bore closure market, giving the company a bigger impact in fast-growing structural heart and endovascular procedures, Ken Crowley, general manager of interventional technologies at Haemonetics, said in a statement.”
  • Per MedCity News,
    • “Health tech may be getting a new heavyweight — though the deal is still in its early stages.
    • “Last month, reports emerged that Matt Holt, former managing director and president of private equity at New Mountain Capital, had left the New York City firm to start a new venture combining five of its health tech portfolio companies in a deal valued at more than $30 billion. 
    • “The creation of the new company — apparently to be named Thoreau after essayist and naturalist Henry David Thoreau — is not yet finalized, but steps are underway to move the process forward, an anonymous source familiar with the transaction told MedCity News. The source said significant diligence, analysis and capital-raising efforts are still underway.
    • “The five New Mountain-backed startups that Holt is in discussion to acquire are Datavant, Machinify, Office Ally, Smarter Technologies and Swoop. Anonymous sources close to the deal told media outlets that the new entity, called Thoreau, is being backed by London-based alternative asset manager ICG Strategic Equity.” * * *
    • “Though Thoreau is not yet a done deal, experts think the move represents a major bet on scale and integration in the health tech sector.”

Thursday Report

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

From Washington, DC,

  • Healthcare Dive reports,
    • “The House voted 230-196 on Thursday to extend expired subsidies for Affordable Care Act plans for three years, with 17 Republicans joining their colleagues across the aisle in support.
    • “The vote sends the bill to the Senate, where it’s expected to be dead on arrival. Though, some moderate senators are working on a compromise proposal, and the support for an extension could push the group to arrive at a solution.”
  • STAT News adds,
    • “A large bipartisan group of House and Senate lawmakers met hours before the vote to discuss plans for a Senate compromise on the subsidies. They left the meeting sounding optimistic, though there are still important details to be worked out.
    • “From the sounds of it, the Senate is planning on finalizing some text by Monday or Tuesday of next week with what their framework will look like,” said Rep. Rob Bresnahan (R-Pa.) as he left the meeting.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the Federal Workforce Data (FWD) website, a modern platform that replaces the outdated FedScope system and delivers faster, more transparent access to federal workforce data.
    • “The new site, available at data.opm.gov, introduces predictable monthly data updates, interactive visualizations, downloadable datasets, and improved transparency around data quality addressing long-standing challenges with delayed releases and limited usability under FedScope.
    • “The Federal Workforce Data website delivers timely, transparent data in a format that is easy to use and built for the future,” OPM Director Scott Kupor said. “This is a major step forward for accountability and data-driven decision-making across government.”
    • “The FWD website also expands publicly available workforce information, including new data on retirement eligibility, telework and remote work, administrative leave, performance ratings, and federal hiring activity.
    • ‘OPM will continue releasing new data, visuals, and features on the site each month and will iterate on the platform as user feedback is received. This launch represents just the beginning, with regular updates and new enhancements planned on an ongoing basis.”
  • Bloomberg Law tells us,
    • “Eli Lilly & Co. plans to take part in the Trump administration’s drug pricing model that seeks to expand access to diabetes and obesity treatments covered under Medicare and Medicaid.
    • “Consistent with a November 2025 agreement with the Trump administration to expand access to obesity medicines and reduce patient costs, “Lilly plans to participate in the voluntary BALANCE model to expand access to GLP-1s in both Medicare and Medicaid,” a company spokesperson said in an email.
    • “The model “will reflect the same terms we have already agreed to regarding GLP-1 pricing and coverage criteria,” said the company, which manufacturers obesity and diabetes drugs Zepbound and Mounjaro.”
  • The Wall Street Journal informs us,
    • “Sending time-sensitive documents like college applications, check payments, tax returns, insurance appeals and ballots through the mail?
    • “You might want to drop off the letter a few days earlier or head to the post office and ask a mail clerk to manually postmark the letter if getting proof of the date is required for meeting a deadline. Otherwise, you risk missing an important deadline for sending your mail.
    • “Since Dec. 24, a postmark no longer shows the date you deposited a piece of mail with the U.S. Postal Service. That means a letter dropped in a mailbox on Monday could be postmarked on Wednesday, if that was the day it got to a processing facility.”
  • Per a PCMA news release,
    • “Marking a new era for the organization, today the board of directors of the Pharmaceutical Care Management Association (PCMA) [, a PBM trade association,] announced that David Marin has been named its new President and CEO, following a thorough search. Marin brings three decades of public policy and coalition-building experience to PCMA and joins the organization from Viatris, a pharmaceutical manufacturer, where he was global head of government affairs, public policy, and advocacy.
    • “Concurrently, the PCMA board announced that Brendan Buck, a seasoned public affairs leader, will serve in the new role of Chief Communications Officer. Both David and Brendan will begin January 20, 2026.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “FDA exempts more wearable, AI features from oversight. In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.” * * *
    • “The first guidance clarifies the FDA’s thinking on what constitutes a wellness device. It offers broader leeway to wearables that provide readings around heart rate, blood pressure and blood glucose, so long as they are intended solely for wellness purposes.” * * *
    • “In a separate guidance, the FDA unveiled significant changes to how it regulates clinical decision support tools. The biggest change is to a section describing how the FDA interprets whether software is providing recommendations to healthcare providers. Software that provides a sole medical recommendation can now be exempt from regulation. Under a previous guidance, it would have been considered a medical device.” 
  • On related note, Beckers Health IT offers “four takeaways from a Jan. 5 Amazon blog post” concerning Amazon’s development of “wearable health AI since its acquisition of startup Bee.”
  • Cardiovascular Business reports,
    • “Aspire Biopharma, a Florida-based biopharmaceutical company, met with the U.S. Food and Drug Administration (FDA)to discuss the future of its new drug for the emergency treatment of suspected heart attacks.  
    • “The drug in question is acetylsalicylic acid 162 mg sublingual powder (OTASU). Based on feedback from the FDA, Aspire Biopharma plans on completing a planned multicenter clinical trial that compares OTASU with the current standard of care (two chewed aspirin tablets). The company’s next step will involve submitting a Section 505(b)(2) New Drug Application, an approach for new drug approvals that is typically faster than submitting a 505(b)(1) New Drug Application.”
    • “The FDA’s constructive feedback validates our development path and brings us one step closer to providing a faster-acting intervention for heart attack patients,” Kraig Higginson, interim CEO of Aspire Biopharma, said in a prepared statement. “Aligning with the Agency on our clinical requirements significantly de-risks our timeline and we believe the FDA’s response leaves the door open for Aspire to obtain breakthrough therapy status for our OTASA product. We believe OTASA has the potential to become the market-leading emergency treatment, and this regulatory clarity is a vital milestone as we engage in active discussions with potential commercial partners.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The 1st U.S. Circuit Court of Appeals Jan. 7 denied the government’s motion for a stay in a lawsuit filed by the AHA, the Maine Hospital Association and four safety-net health systems challenging the Department of Health and Human Services’ 340B Rebate Model Pilot Program. This means that the program remains on hold. 
    • “The 1st Circuit wrote: “In a careful and thorough decision, the district court granted the preliminary injunction. It determined that the federal government had failed to consider the hospitals’ reliance interests and other important aspects of the problem in enacting the new program and that the hospitals would face irreparable harm, including potential closure, without an injunction during the course of the litigation. … We conclude that the federal government has failed to carry its burden of ‘ma[king] a strong showing that [it is] likely to succeed on the merits’ in this appeal and thus deny its stay request.” 
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “The First Circuit recognized that the district court’s decision halting the 340B Rebate Program was ‘careful and thorough’ — and correct. The AHA remains pleased that these courts have put on hold this harmful program that would have a devastating effect on America’s most vulnerable patients and communities, and the hospitals that serve them.” 
    • “The 1st Circuit ruling follows a Dec. 29 decision from the U.S. District Court of Maine granting a preliminary injunction blocking implementation of the program, which was scheduled to go into effect Jan. 1, 2026.”
  • Fierce Healthcare relates,
    • “Anthem’s California companies are suing 11 Prime Healthcare facilities, alleging that the hospitals committed fraud by “knowingly flooding” the No Surprises Act’s dispute resolution process.
    • “The health insurer said in a complaint filed Monday [in the U.S. District Court for the Central District of California, No. 8:26-cv-00023] that the defendant facilities submitted more than 6,000 ineligible claims to the independent dispute resolution, or IDR, which led to millions in “wrongfully obtained awards.” Anthem said that, in aggregate, the Prime hospitals received $15 million more than the insurer would have paid originally.
    • “The typical award through IDR was six times what a contracted provider would have been paid, according to the lawsuit.
    • “Anthem alleged in the complaint that Prime Healthcare has acquired facilities that would then cancel contracts with insurers and that the hospitals under its umbrella “aggressively pursued collection” of out-of-network claims.”

From the public health, medical / Rx research front,

  • Beckers Hospital Review reports,
    • “Some hospitals are postponing elective procedures to preserve capacity as a severe flu season pushes admissions higher and fills emergency departments across the U.S.
    • “UnityPoint Health-Des Moines said it will delay some surgeries and procedures requiring overnight admission through Jan. 13 amid a sharp rise in flu cases. 
    • “Our priority is to focus resources on patients with the most urgent needs while maintaining the highest standard of care,” the system said in a statement to the Des Moines Register on Jan. 8. “We are closely monitoring hospital capacity and will provide updates as needed.”
    • “Influenza admissions are climbing nationally, and experts say the peak is still weeks away. CDC data shows more than 33,000 people were hospitalized with the flu during the week ending Dec. 27, and hospital leaders are bracing for continued increases.”
  • and
    • “As the U.S. confronts one of its most severe flu seasons, Tamiflu, a common antiviral medication to treat influenza, is in shortage in pockets across the country, Bloomberg reported Jan. 7. 
    • “In Utah, where flu activity is high, pharmacists are not yet reporting supply issues. But in Georgia, where flu activity is very high, drugstores are scrambling for Tamiflu (oseltamivir). 
    • “Hospitals are also asking if we have it,” Parth Patel, PharmD, a pharmacist at an independent pharmacy in Georgia, told Bloomberg.” 
  • Fierce Pharma lets us know,
    • “As evidence of tirzepatide’s efficacy mounts across a range of cardiometabolic conditions, Eli Lilly has shown that taking the incretin medicine alongside another of its drugs, Taltz, could lead to better outcomes for patients living with both psoriatic arthritis (PsA) and obesity.
    • “In an open-label phase 3b trial, the co-administration of Lilly’s IL-17A antagonist Taltz (ixekizumab) and dual GIP/GLP-1 receptor agonist Zepbound (tirzepatide) helped more patients achieve improvements in PsA activity and lose a certain percentage of body weight than Taltz alone, the company reported Thursday.”
  • MedPage Today cautions,
    • “Weight loss and cardiometabolic benefits were fully reversed within 2 years for people who stopped weight management medications, a systematic review and meta-analysis showed.
    • “Adults with overweight or obesity who stopped using weight-loss drugs regained an average of 0.9 lb (95% CI 0.7-1.1) each month and returned to their baseline weight within 1.7 years compared with controls in an analysis of randomized trial data, reported Sam West, PhD, of the University of Oxford in England, and colleagues.
    • “All cardiometabolic markers — HbA1c, fasting glucose, cholesterol, triglycerides, and systolic and diastolic blood pressure — were projected to return to baseline within 1.4 years after cessation, the researchers wrote in The BMJopens in a new tab or window.
    • “Regardless of initial weight loss, people regained weight faster, by 0.7 lb per month, after stopping weight management medications compared with behavioral weight management programs.”
    • “As obesity is a chronic and relapsing condition, prolonged treatment with WMM [weight management medication] may be required to sustain the health benefits,” West and co-authors noted. “This evidence cautions against short term use of WMMs, emphasizes the need for further research into cost effective strategies for long term weight control, and reinforces the importance of primary prevention.”
    • “The results didn’t come as much of a surprise to Qi Sun, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School in Boston. It’s “well documented that reduced adherence to, or cessation of, dietary and lifestyle interventions leads to similar patterns of weight regain,” he wrote in an accompanying editorial.”
  • CNN Health points out,
    • “Common preservatives used to keep food safe and extend shelf life may be linked to a higher risk of several cancers and type 2 diabetes, according to two new studies from France.
    • “These are very important findings for preservatives that are not only widely used in the French and European markets, but also in the United States,” said senior author Mathilde Touvier, principal investigator of the NutriNet-Santé study used to conduct the research.
    • “The NutriNet-Santé study, which began in 2009, compares over 170,000 participants’ web-based reports on diet and lifestyle with their medical data stored in the French national health care system.
    • “These are the two first studies in the world investigating the associations between exposure to these food additives and cancer and type 2 diabetes,” said Touvier, who is also the director of research at France’s National Institute of Health and Medical Research in Paris, “and so we must be very cautious about the message. Obviously, the results need to be confirmed.”
    • “Despite those caveats, “the concern raised about preservatives is one more reason among many to emphasize the personal and public health importance of fresh, whole, minimally processed foods, mostly plants,” Dr. David Katz said in an email.”
  • MedPage Today notes,
    • “Thirty-year outcomes among participants in the Women’s Health Study showed a stepwise increase in major cardiovascular events associated with increasing lipoprotein(a) levels starting around 30-60 mg/dL.
    • “Lipoprotein(a) is a highly atherogenic particle considered to be a genetically determined, unmodifiable cardiovascular risk factor with little contribution from lifestyle.
    • “These findings support screening to identify individuals with very high lipoprotein(a) levels who may benefit from primary prevention therapies.”
  • The Wall Street Journal advises,
    • “One in six seniors were prescribed eight or more drugs simultaneously, with over 3.5 million receiving at least one generally avoidable medicine.
    • “Older adults should annually inventory their medications, research drug labels and interactions, and consult doctors about potential risks.
    • “The Beers Criteria guidelines recommend avoiding certain drugs like benzodiazepines and muscle relaxants for older patients due to side effects.”
  • The Genetic Engineering and BioTechnology News lets us know,
    • More than 50 million Americans live with chronic pain. Drugs are currently available; however, close to 80% of the 600,000 deaths attributed to drug use in 2019 were related to opioids with about 25% of those deaths caused by opioid overdose. In addition, nearly half of Philadelphians who responded to a 2025 Pew survey reported knowing someone with opioid use disorder (OUD) and one-third knew someone who had died as the result of an overdose. Taken together, novel approaches to pain management are a large, unmet need.
    • Now, a gene therapy opens a new avenue for targeting pain centers in the brain while eliminating the risk of addiction from narcotics treatments. This work is published in Nature in the paper, “Mimicking opioid analgesia in cortical pain circuits.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “The Council for Affordable Quality Healthcare is transitioning away from its nonprofit structure, sharing how the country’s biggest health insurance companies are now serving as owners, according to a Jan. 6 news release.” * * *
    • “CAQH was founded by health plans that recognized the need to take unnecessary administrative costs out of the healthcare system,” Mr. Kaja said. “That same determination to solve hard problems and move the industry forward defines CAQH today. The board’s decision reflects our confidence in CAQH’s ability to keep challenging convention and improving how the healthcare system works for everyone.”
    • “The release added the restructuring will allow CAQH to further advance products and interoperability.”
  • Fierce Healthcare informs us,
    • “Pomelo Care launched in 2021 with a virtual maternity care model that supplements traditional pregnancy care by proactively predicting and addressing risk factors.
    • “The startup is expanding beyond maternity care to more broadly to serve women’s and children’s health needs and it picked up $92 million in series C funding to fuel its growth. Pomelo Care’s services now span reproductive care, pregnancy, pediatrics and hormonal health as well as perimenopause and menopause. The company also supports long-term preventive care and condition management.
    • “The funding round was led by Stripes and backed by Andreessen Horowitz, PLUS Capital, Atomico, BoxGroup and SV Angel. With the series C funding, Pomelo Care is now valued at $1.7 billion, the company said.”
  • Fierce Pharma notes,
    • “It’s been more than 10 years since the FDA signed off on the U.S.’ first biosimilar product, opening up what was originally expected to be an easily accessible, cheaper drug market featuring heightened competition and potential new savings for patients.
    • “Now, more than 80 biosimilar approvals later, the promise of broad biosimilar adoption and lower drug prices hasn’t played out as initially anticipated, leaving the biosimilar market at a critical inflection point as it enters 2026, with policy changes and major patent cliffs creeping ever closer. 
    • “2025 was marked by “extraordinary change and progress within the biosimilar landscape,” highlighting both the opportunities and the challenges facing the field, Samsung Bioepis’ head of U.S. commercial, Thomas Newcomer, said in the company’s fourth-quarter biosimilar market report.” 
  • Healthcare Dive identifies “the top healthcare provider trends in 2026. Health systems that address costs, workforce planning and portfolio strategy may be better positioned as reimbursement headwinds intensify this year.”
  • MedTech Dive calls attention to “4 medtech topics to watch in 2026. From insurance coverage questions to M&A and tariffs, here are the top storylines to watch in the medical device space in 2026.”

Midweek report

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

From Washington, DC

  • The Wall Street Journal reports,
    • “Republicans and Democrats are nearing a deal to extend federal health-insurance subsidies for two years, with abortion coverage remaining a potential stumbling block, GOP lawmakers said.
    • “The proposed framework includes income caps and a new requirement for enrollees to pay at least $5 monthly.
    • “Approximately 20 million Americans previously benefited from enhanced ACA subsidies, which expired at the end of last year.”
  • MSN adds,
    • “Health insurance companies are being summoned to Capitol Hill for a pair of blockbuster hearings as Americans across the country deal with rising costs for their care, Fox News Digital is first to learn.
      “The House Energy & Commerce Committee, which oversees health policy, and the Ways & Means Committee, which has jurisdiction over tax policy, are both holding hearings on the rising cost of healthcare in the U.S.
    • “It’s not immediately clear which companies will be represented or if they will allow executives to appear voluntarily.”
  • Healthcare Dive informs us,
    • “Provider and telehealth groups are urging Congress to take action on Medicare virtual care flexibilities as the sector hurtles toward another deadline when the policies could expire.
    • “The American Medical Association, one of the nation’s largest healthcare lobbying groups, on Monday pressed lawmakers to make the pandemic-era telehealth policies permanent, arguing a “repeated cycle of temporary extensions” has undermined access to care. 
    • “The flexibilities, which expanded reimbursement for telehealth in Medicare, are set to lapse on Jan. 30 — just a few months after the coverage policies were reinstated following the government shutdown this fall.”
  • Modern Healthcare lets us know,
    • “The Centers for Medicare and Medicaid Services may require Chronic Condition Special Needs Plans insurers to be Medicaid contractors.
    • “CMS is concerned that C-SNP growth could jeopardize efforts to integrate benefits for Medicare-Medicaid dual-eligible beneficiaries.
    • “C-SNPs are the fastest-growing Medicare Advantage product.
    • “Humana, Centene and others that specialize in Medicare and Medicaid plans could benefit.”
  • The American Hospital Association News notes,
    • “The Departments of Health and Human Services and Agriculture Jan. 7 released updated dietary guidelines for Americans. The new guidelines suggest prioritizing protein in each meal; full-fat dairy with no added sugars; whole fruits and vegetables; healthy fats from foods such as meats, seafood, eggs, nuts, seeds, olives and avocados; and whole grains, while reducing refined carbohydrates and limiting highly processed foods, added sugars and artificial additives, among other recommendations. The guidelines also include recommendations for infants and children, adolescents, pregnant and lactating women, older adults, individuals with chronic disease, vegetarians, and vegans.” 
  • The Wall Street Journal explains how the new guidelines would impact American diets.
  • The AHA News further notes,
    • “The Centers for Medicare & Medicaid Services has implemented an online form for providers to submit complaints regarding Medicare Advantage plans. A CMS memorandum issued Dec. 22 announced implementation of the form. Subsequently, CMS has stated that all provider complaints should be submitted using the form effective Jan. 5, 2026. The form requests basic information about the complainant, beneficiary, provider, the Medicare Advantage plan and a complaint summary and provides optional fields for dates of service and the claim number.” 
  • Federal News Network relates,
    • “Updated guidance on federal telework and remote work from the Office of Personnel Management now emphasizes as much in-person presence as possible for the federal workforce.
    • “OPM’s latest revisions aim to better align with the Trump administration’s return-to-office orders from January 2025. The new guidance, which OPM updated in December, now says federal employees should generally be “working full-time, in-person.” And while federal telework and remote work can be “effective” tools on a case-by-case basis, OPM said those flexibilities “should be used sparingly.”
    • “Beyond that, agencies should also have procedures for verifying that employees are working on-site, full-time, unless given an exemption, OPM said. And in the limited cases where employees are teleworking, agencies should have a process to determine whether teleworking is successful, or if it should be revoked.”
  • and
    • “The federal retirement inventory has reached yet another new high. The Office of Personnel Management now has over 50,000 applications still awaiting a finalized annuity. The increase comes after more than 13,000 retirement applications entered OPM’s systems in December. It’s taking OPM about 67 days to process a retirement case from start to finish. But OPM’s numbers don’t include any retirement cases still pending with agencies. Some retirees report major delays in receiving their payments, months after separating from government.”
  • Govexec points out,
    • “Many federal retirees wonder whether their Federal Employees Health Benefits coverage changes when they become eligible for Medicare at age 65. One of the most common concerns is whether FEHB reduces or limits benefits if a retiree chooses not to enroll in Medicare Part B.
    • “The short answer is no – your FEHB plan continues fully, and your coverage does not decrease. However, the way your benefits work can change depending on whether you enroll in Part B. This article explains how FEHB and Medicare coordinate, potential cost implications, and key considerations for individuals and married couples.”

From the Food and Drug Administration front,

  • Biopharma Dive calls attention to “5 FDA decisions to watch in the first quarter of 2026. By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it rejected two years ago.”
  • Cardiovascular Business reports,
    • “Gore, the medical division of W.L. Gore & Associates, has received U.S. Food and Drug Administration (FDA) approval for a new vent designed to help treat deep venous disease in the inferior vena cava (IVC), iliac and iliofemoral veins. 
    • “The Gore Viabahn Fortegra Venous Stent represents the latest addition to the company’s Viabahn family of medical devices. It includes an open-structure, self-expanding wire-wound frame made of nitinol and a polytetrafluoroethylene polymer lattice. 
    • “According to Gore, the newly approved device was built with conformability, strength and fracture resistance in mind. In addition, it can be used to treat a wide range of patients due to the availability of several sizes.” 
  • MedTech Dive adds,
    • “Johnson & Johnson said Wednesday it has submitted its Ottava soft tissue robotic surgery system to the Food and Drug Administration for de novo classification in general surgery. The company has applied for marketing authorization in multiple procedures within the upper abdomen.
    • “The application is supported by data from the company’s investigational device exemption study in Roux-en-Y gastric bypass, a type of weight-loss surgery that creates a small pouch from the stomach to reroute food to the small intestine.
    • “J&J said it also received IDE approval in late 2025 to begin a U.S. clinical trial to study Ottava in inguinal hernia procedures, one of the most common surgeries in the U.S.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “Officials have confirmed 20 more measles cases in Utah, raising the state total to 176, and the Centers for Disease Control and Prevention (CDC) released nationwide totals for 2025, noting 2,144 confirmed cases
    • “Of the 176 infections in Utah, 129 (73%) are in the Southwest Utah health district, which has seen high measles activity alongside neighboring Mohave County, Arizona.
    • “In other hot spot news, three North Carolina siblings who had recently visited Upstate South Carolina now have measles infections, according to an update from the North Carolina Department of Health and Human Services. 
    • “The family had visited Spartanburg County, South Carolina, where there is a large ongoing measles outbreak approximately 1-2 weeks before the children became sick,” North Carolina officials said.
    • “South Carolina has reported 211 cases associated with an outbreak in the Upstate region.”
  • Per a National Institutes of Health news release,
    • “A research team supported by the National Institutes of Health (NIH) has found that conditions known to cause nerve damage, or neuropathy, disrupt a crucial energy-transfer process between special support cells called satellite glial cells (SGCs) and the sensory neurons they surround. The investigators discovered that the energy producing machinery of cells, known as mitochondria, are transferred through tiny tubes that form between the SGCs and neurons. They found that this transfer became obstructed in animal models of chemotherapy and diabetes, while restoring it attenuated pain behavior and promoted nerve regeneration after nerve injury. 
    • “The results of this study highlight a new avenue for potential neuropathy treatments and provide insight into how some of the body’s most energy-hungry cells are powered.” 
  • Per Cardiovascular Business,
    • “Patients with active cancer who undergo transcatheter aortic valve replacement (TAVR) are associated with short- and mid-term outcomes comparable to those without cancer, according to new findings published in the International Journal of Cardiology. Long-term mortality rates appear to be higher for cancer patients, though there is considerable variability from one type to the next.
    • “Cancer and aortic valve stenosis (AS) are among the leading causes of mortality in developed countries,” wrote first author Mark Kheifets, MD, a researcher with the cardiology division at Rabin Medical Center in Israel, and colleagues. “Advances in cancer diagnosis and treatment have significantly improved survival rates in recent years, leading to a growing number of patients diagnosed with both cancer and AS. Additionally, individuals with a history of cancer treatments, particularly those exposed to chest radiation, face an elevated risk of developing AS. Although severe AS portends a similarly poor prognosis as cancer without treatment, managing AS in patients with cancer may pose unique challenges, as these individuals are often frail, burdened with multiple comorbidities, and may experience increased thrombogenicity due to malignancy and its treatments. Furthermore, they are often prone to lower hemoglobin and platelet counts, increasing their risk of bleeding complications.”
  • The Society of Actuaries released a report last month titled “Quantifying the Effects of Mental Health on U.S. Suicide and Mortality Rates.”
    • “Key findings include:
      • “Strong geographic clustering: Neighboring counties show highly correlated mortality and suicide outcomes, confirming that regional social and economic context meaningfully influences risk.
      • “Socio-economic disparities: County-level education, housing prices, and marriage rates are among the strongest predictors of suicide risk, though effects differ by age and sex. Higher education and home values are generally associated with reduced suicide risk for men but have mixed or opposite effects for women in later life.
      • “Mental health as a leading indicator: County-level mental health distress is consistently associated with higher mortality and suicide rates. The relationship is most pronounced among youth and young adults.
      • “Temporal persistence: Spatial and temporal correlations suggest stable, long-term regional patterns in both overall mortality and suicide.”
  • BioPharma Dive tells us,
    • “GSK and Ionis Pharmaceuticals said their experimental hepatitis B medicine succeeded in two Phase 3 trials, offering patients what might be a “functional cure” for the disease.
    • “In releases issued Wednesday, the companies didn’t provide details on the effects seen in the B-Well 1 and B-Well 2 studies. The drug, bepirovirsen, met the primary endpoint in both trials and “demonstrated a statistically significant and clinically meaningful functional cure rate,” the companies said.”

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

  • HHS’s Agency for Healthcare Quality and Research reports,
    • “In 2024, average [U.S. employer sponsored] health insurance premiums were $8,486 for single coverage, $16,931 for employee-plus-one coverage, and $24,540 for family coverage, representing increases of 3.7, 4.9 and 2.5 percent, respectively, from 2023.
    • “Average employee contributions in 2024 increased from the previous year by 9.1 percent for single coverage ($1,789) and 5.2 percent for employee-plus-one coverage ($4,707).
    • Average deductibles for single plans increased by 8.0 percent to $2,085 and average family deductibles increased by 8.8 percent to $4,063 from 2023 to 2024.
    • “The offer rate, total number of enrollees and take up rates did not change significantly overall or by firm size from 2023 to 2024.
    • “Over the period from 2008 to 2024, offer rates declined by over 10 percentage points among small firms, from 61.6 percent in 2008 to 50.5 percent in 2024.
    • “From 2008 to 2024, the overall take-up rate fell by 9.7 percentage points (from 78.7 to 69.0 percent) and take-up rates fell by similar amounts in small and large firms.”
  • BioPharma Dive relates,
    • “Eli Lilly is deepening its investment in inflammatory diseases, spending $1.2 billion to buy Ventyx Biosciences for an experimental drug that has the potential to treat an array of immunological conditions. 
    • “The Indiana-based manufacturer of obesity drug Zepbound announced Wednesday it will spend $14 per share to buy Ventyx, which in October reported promising data for an oral immune disease drug code-named VTX3232.
    • “The per-share figure represents a 62% premium to Ventyx’s average trading price for the 30 days ending Jan. 5. News of the pending acquisition was first reported by the Wall Street Journal on Tuesday, sending shares close to the value Lilly ultimately paid.
  • Fierce Healthcare informs us,
    • “Eli Lilly has dominated headlines in recent months, recently taking the crown as the most valuable company in the biopharma industry by market cap. And the song remains much the same in analytics firm Clarivate’s Drugs to Watch 2026 report.
    • The annual outlook, which identifies (PDF) 11 potential blockbusters and transformative medicines, highlights two cardiometabolic treatments from the Indianapolis company, which have yet to be approved but could ultimately take the place of its current cash cows Mounjaro and Zepbound.
    • “Lilly’s investigational treatments are daily GLP-1 pill orforglipron, which is slated for an FDA decision by March of this year, and triple-action, weekly injection retatrutide, which Clarivate expects will be ready for launch in 2028.
    • “Both assets are under development in obesity, diabetes and a host of other related indications.” 
  • Adam Fein, writing in his Drug Channels blog, lets us know,
    • “For 2025, brand-name drugs’ average list prices grew by only 3.5%, but net prices declined. When manufacturers’ rebates and discounts are factored in, drugs’ average net prices—both before and after inflation—fell. Details and additional commentary below.
    • “As I have been predicting, the gross-to-net bubble is deflating due to the combined impacts of government actions and consumer behavior. 
    • “For 2024 and 2025, manufacturers reduced the wholesale acquisition cost (WAC) list prices for more than 20 brand-name drugs. For 2026, manufacturers will cut prices on at least 15 more drugs, which will reduce gross brand-name revenues by $35 to $40 billion. List prices are dropping by –25% to –85%.
    • “The data leave no doubt: the bubble is finally leaking air. We are entering the Net Pricing Drug Channel (#NPDC)—a market environment in which net prices, not list prices, drive access, economics, and strategy. 
    • “The NPDC will reward simplicity, punish rebate dependence, and force every channel participant to rethink how money actually moves. Time to get ready.”
  • Per Beckers Hospital Review,
    • “PAI Pharma has acquired Nivagen Pharmaceuticals in a move it said was aimed at expanding the domestic supply of sterile injectable drugs.
    • “Nivagen operates a recently built aseptic manufacturing facility in Sacramento, Calif., that produces IV bags, vials, prefilled syringes and cartridges. The acquisition brings more than 20 ready-to-use injectable products into PAI’s pipeline, complementing its existing portfolio of 10 sterile products in development and four currently on the market, according to a Jan. 6 PAI Pharma news release.
    • “Company leaders said the acquisition extends PAI’s focus on quality and reliability into hospital-focused injectable therapies — a drug class frequently affected by shortages in the U.S. healthcare system.”
  • and
    • “Rock Regional Hospital in Derby, Kan., has permanently closed after a federal judge allowed its eviction to proceed, ending a months-long legal battle over unpaid rent, according to NBC affiliate KSN.com.
    • “Rock Regional Hospital is permanently closed,” the hospital wrote in a Jan. 7 Facebook post. “There is no emergency care available at this location. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency department.”
  • Per MedTech Dive,
    • “STAAR Surgical shareholders have voted to reject Alcon’s revised acquisition offer after a contentious proxy battle.
    • “The maker of implantable lenses for the eye intends to terminate its merger agreement with Alcon, STAAR said Tuesday, based on the preliminary results from a special shareholder meeting. Final results from the meeting will be reported in a regulatory filing. Neither company will pay a termination fee.
    • “STAAR said it would remain a stand-alone, publicly traded company.”
  • Fierce Healthcare tells us,
    • “OpenAI continues its push into healthcare with the launch of ChatGPT Health, a new feature that connects its AI chatbot with users’ medical records and wellness apps for more personalized answers to medical questions.
    • “People already are using publicly available AI chatbots to ask healthcare-related questions. More more than 800 million regular users of ChatGPT, 1 in 4 submits a prompt about healthcare every week, according to OpenAI. More than 40 million turn to ChatGPT every day with healthcare questions, according to an OpenAI report.
    • “OpenaI says ChatGPT Health builds on this so the AI chatbot’s responses are informed by users’ health information and context, the company said in an announcement. 
    • “Users can now securely connect medical records and wellness apps—like Apple Health, Function and MyFitnessPal—so ChatGPT can help them understand recent test results, prepare for appointments with their doctor, get advice on how to approach diet and workout routines, or understand the tradeoffs of different insurance options based on healthcare patterns, the company said.
    • “The new feature has additional, layered protections designed specifically for health, including purpose-built encryption and isolation to keep health conversations protected and compartmentalized, OpenAI said. Conversations in Health are not used to train OpenAI’s foundation models, the company said.
    • “The company said it was designed in close collaboration with physicians. ChatGPT Health is designed to support, not replace, medical care, and it is not intended for diagnosis or treatment, the company said.”

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.” 

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.  

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.”