Midweek report

Medical / Rx research

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.” 

Weekend update

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

From Washington, DC

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

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.  

Tuesday report

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

From Washington, DC,

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

From the public health and medical / Rx research front,

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

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

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

Monday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

In notable death news,

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

Weekend update

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

From Washington, DC

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

From the Food and Drug Administration front,

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

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

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

From the U.S. healthcare business front,

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

Tuesday report

David Ermer–CMS, FDA, HSA, Medical / Rx research, Medicare, OPM, Patient safety, Rx coverage, U.S. Healthcare–

The FEHBlog will be on hiatus following today until next December 27 Cybersecurity Saturday. Merry Christmas and Jingle Bells to all.

From Washington, DC,

  • Federal News Network reports,
    • “There’s an old adage that tells someone to “put your money where your mouth is.” Well, Don Bauer is going all in at the Office of Personnel Management.
    • “Bauer wrote a column for Federal News Network criticizing OPM’s plans to consolidate and modernize human resources systems across the government. In his Oct. 30 column, Bauer wrote that OPM’s initial plan was “not modernization; it’s madness.”
    • “Now Bauer is in charge of that madness. Federal News Network has learned Bauer will join OPM on Jan. 12 as its new deputy associate director for workforce standards and data center (WSDC) in the HR Solutions (HRS) office. He will be leading the HR Line of Business, the quality service management office (QSMO) and human capital management core modernization effort.”
  • Good luck, Mr. Bauer.
  • Mercer tells us,
    • “In Notice 2026-5, IRS and the Treasury Department provide key details about health savings account (HSA) enhancements passed as part of the One Big Beautiful Bill Act (OBBBA) (Pub. L. No. 119-21), clearing the way for employers to continue offering telehealth and to begin offering direct primary care service arrangements (DPCSAs) to otherwise HSA-eligible employees.
    • “Effective for the 2025 plan year, OBBBA reinstated and made permanent COVID-19-era telehealth relief allowing HSA-compatible high-deductible health plans (HDHPs) to cover telehealth and other remote care services before the statutory minimum deductible is satisfied.
    • “Beginning Jan. 1, 2026, OBBBA also allows individuals enrolled in DPCSAs to remain eligible to make or receive HSA contributions and treats certain bronze and catastrophic plans as HDHPs.
    • “This article summarizes the Notice 2026-5 question-and-answer guidance, addressing significant topics such as which services the IRS will treat as “telehealth and other remote care services;” whether a DPCSA can separately bill for primary care services or offer services beyond primary care; and whether a bronze or catastrophic plan can be an HDHP if purchased using an employer-sponsored individual coverage health reimbursement account (ICHRA).
    • ‘Comments about the guidance are due March 6, 2026.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) announced today a new voluntary test of a model that is designed to enable Medicare Part D plans and state Medicaid agencies to cover GLP-1 medications used for weight management and metabolic health improvement, while helping control costs for patients and taxpayers.
    • “The Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model builds on emerging evidence that combines access to GLP-1 medications with access to evidence-based lifestyle supports to achieve better long-term health outcomes. The model represents a major step toward potential expanded access and affordability for millions of Americans. 
    • “Today’s announcement builds upon our historic Most Favored Nations drug pricing deals’ goal of democratizing access to weight-loss medication, which has been out of reach for so many in need,” said CMS Administrator Dr. Mehmet Oz. “These actions further the administration’s bold plan to reform our country’s health systems and Make America Healthy Again. With the BALANCE Model, we’re pairing breakthrough science with healthy living to cut costs while empowering Americans to take control of their health.”
    • “Under the model, CMS negotiates directly with pharmaceutical manufacturers of GLP-1 drugs for lower net prices and standardized coverage terms. Negotiation areas include: 
      • “Guaranteed net pricing and potential out-of-pocket limits for beneficiaries;
      • “Standardized coverage criteria; and
      • “Evidence-based lifestyle support offerings.”
    • “To learn more about the BALANCE Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/balance.” * * * 
    • “Prior to the launch of the BALANCE model, CMS also plans to implement a new Medicare GLP-1 payment demonstration beginning in July 2026, which will serve as a short-term bridge to the model. This additional payment demonstration means that Medicare beneficiaries can start accessing these important medications at prices negotiated by the Administration as soon as possible.
    • “The GLP-1 payment demonstration will operate outside of the Medicare Part D benefit’s coverage and payment flow, which means that Part D Plan Sponsors will not carry risk for eligible GLP-1 products furnished under the demonstration. Beneficiaries enrolled in Medicare Part D who meet the negotiated access criteria will have access to these drugs. Under the demonstration eligible Medicare beneficiaries will pay $50 for a month of GLP-1 medications.
    • “CMS will provide additional information on the design and implementation of the GLP-1 payment demonstration in early 2026.
  • The Wall Street Journal points out,
    • “About half of 20 million Americans with FSA [healthcare flexible spending] accounts let some of their money expire each year.
    • “The average forfeited amount per individual is over $400, and unused FSA money generally returns to employers.
    • “FSAs offer tax savings; a worker in the 22% tax bracket contributing $1,500 could save as much as around $500 in taxes.”
  • Per an AHIP news release from December 18,
    • “AHIP’s Board of Directors has elected Jim Rechtin, President and CEO of Humana, as Board Chair effective January 1, 2026. Rechtin succeeds Pat Geraghty, who announced his retirement after 14 years leading GuideWell and Florida Blue effective December 31, 2025.
    • “I was proud to be part of AHIP’s work this year to unite our industry around voluntary commitments to simplify prior authorization – an important ongoing effort that shows what’s possible when health plans work together to deliver for patients. As Board Chair, I look forward to taking the same cooperative approach to helping health consumers navigate the system and access high-quality, affordable care,” Rechtin said.

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • “The FDA has expanded the indication of ferric maltol (Accrufer) capsules for the treatment of iron deficiency to include adolescents.
    • “The approval makes the drug the first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older. It was first approved in 2019 for adults with iron deficiency.
    • “The expanded indication was supported by the phase III FORTIS trialopens in a new tab or window in which 24 patients ages 10-17 received age-based dosing of ferric maltol twice daily, and showed a clinically meaningful average increase in hemoglobin of 1.1 g/dL at 12 weeks. This would be the expected average increase in hemoglobin with one blood transfusion, the agency noted.”
  • MedTech Dive reports,
    • “Edwards has received Food and Drug Administration approval for its Sapien M3 mitral valve replacement system, the company said Tuesday.
    • “The device is intended for people with moderate to severe mitral regurgitation, a heart condition where the valve between the left heart chambers doesn’t fully close, allowing blood to leak back through. Sapien M3 is indicated for people who are deemed unsuitable for surgery or transcatheter edge-to-edge repair therapy, a minimally invasive procedure to fix a valve by clipping its leaflets together.”
  • and
    • “The Food and Drug Administration said Monday it has issued a Class I recall notice regarding Medtronic’s removal of heart vent catheters.
    • “Medtronic previously asked customers to quarantine lots of its DLP Left Heart Vent Catheters in response to an issue linked to three serious injuries. The FDA published an early alert about the recall in August.
    • “The agency updated its notice this week to inform the public that it has classified the issue as a Class I recall.” 

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Infants given the monoclonal antibody nirsevimab, which provides temporary immunity to respiratory syncytial virus (RSV), had lower risks of related hospitalizations and severe outcomes than those whose mothers got the RSVpreF vaccine, according to a population-based study.
    • “The study may be the first to compare the two interventions in a real-world setting in a national population.
    • “The study and two others reported alongside it join a growing body of real-world evidence demonstrating the effectiveness of RSV products in protecting against severe outcomes related to RSV in the youngest kids.”
  • Health Day informs us,
    • “People on the verge of type 2 diabetescan cut their risk of death from heart disease by more than 50% if they bring their blood sugar levels back to normal, a new study says.
    • “Patients with prediabetes reduced their heart risk by up to 58% when they successfully lowered their blood sugar, researchers reported in The Lancet Diabetes & Endocrinology.
    • “This is an important finding, given that recent studies have concluded people with prediabetes can’t lower heart disease risk through lifestyle changes like exercise, weight loss and a healthy diet, researchers said.
    • “Essentially, reversing prediabetes by lowering blood sugar matters more to your heart than any healthy habits you adopt, researchers said.
    • “This study challenges one of the biggest assumptions in modern preventative medicine,” said lead researcher Dr. Andreas Birkenfeld, a reader in diabetes at King’s College London.
  • Medscape points out,
    • “A trio of large observational studies reported at the San Antonio Breast Cancer Symposium (SABCS) 2025 suggest that GLP-1 receptor agonists may improve outcomes in some women with breast cancer.
    • “Two studies reported an overall survival benefit of GLP-1 use in certain patients with breast cancer, including those with ductal carcinoma in situ (DCIS) and invasive hormone receptor (HR)-positive nonmetastatic disease, and a third found improvements in a range of toxicities among patients receiving chemotherapy.
    • “These studies, presented during a poster session, add to other emerging research indicating that GLP-1 drugs could have implications across the breast cancer trajectory, including prevention, active therapy, and posttreatment survivorship, explained study discussant Jasmine S. Sukumar, MD, with University of Texas MD Anderson Cancer Center in Houston.”
  • Fierce Pharma relates,
    • “Just days after an upbeat R&D event, Neurocrine Biosciences has found itself having to report a phase 3 failure.
    • “The company’s Ingrezza (valbenazine), approved to treat certain uncontrolled movement conditions, failed to make a significant difference in a phase 3 trial for patients with dyskinesia due to cerebral palsy (CP), Neurocrine announced Monday.
    • “Ingrezza didn’t outperform placebo on improving involuntary, jerky movements of the body after 14 weeks of treatment, causing the phase 3 trial to miss its primary endpoint. The study, dubbed Kinect-DCP, also did not meet key secondary endpoints, according to Neurocrine.”
  • and
    • “A patient in an open label extension study of Pfizer’s hemophilia treatment Hympavzi has died, the company and several hemophilia advocacy groups confirmed this week.
    • “Pfizer is now working with its trial investigator and independent data monitoring committee to accrue more information and better understand the circumstances behind the incident, the New York drugmaker wrote in a letter to the hemophilia community, which was posted online (PDF) by the World Federation of Hemophilia (WFH) on Dec. 22.”
  • STAT News reports,
    • “Oncologists have been moving away from the notoriously unpopular neutropenic diet. It requires nearly all food to be cooked to high temperatures — or, as some have described it, “boiled to death” — to reduce the risk of food-borne illnesses. But since evidence in recent years suggested the diet didn’t actually help ward off infections, doctors started leaning away from a strict neutropenic diet.
    • “Now, a new study published last week in the Journal of Clinical Oncology is giving some physicians pause about fresh fruits and vegetables for patients whose treatment involves heavy suppression of the immune system, particularly neutrophils, white blood cells that are key to preventing infection. Contrary to research in the past, the trial found that certain blood cancer patients who were allowed a less restrictive or liberalized diet had 11% more infections than patients who were prescribed the neutropenic diet.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Analysts expect health insurance companies to be better positioned for 2026 after adjusting their offerings.
    • “Medicare Advantage offers the sector the largest potential for improvement because companies will receive a significant increase in federal pay. 
    • “Federal changes to Medicaid and the exchanges will pressure health insurance companies’ finances.”
  • Ernst & Young informs us,
    • “A changing healthcare landscape is shifting economic returns, leading organizations to rethink their value chain position.
    • “Expansion in lower-acuity care and opportunistic mergers and acquisitions can accelerate long-term growth.
    • “Implementing new benefit cost containment strategies and investing in innovative AI solutions can elevate efficiency and performance.”
  • Per a Harvard Business Review article,
    • “U.S. employers are grappling with surging healthcare costs as healthcare prices and service volumes rise. Provider consolidation, high drug prices, labor shortages, and growing chronic disease are fueling the cost increases. Employer have largely responded by shifting expenses to workers. Their track record in pursuing aggressive options—including collective purchasing, tiered plans, value-based care, and advocating for changes in government policies—is poor. The big question is whether they have the will to become more aggressive in pursuing remedies. The outlook is not promising. The reasons include the complexity of the problem, employee resistance to some solutions, and the fact that most employers just don’t have sufficient “skin in the game” to take on the disruption and risk that would be required to bend the healthcare cost curve significantly or sustainably.”
  • The FEHBlog has more confidence in employers.

FEHBlog response to public comment

  • A commenter called into question the statistices upon which AHIP relied in this recent news release which the FEHBlog quoted. In response the FEHBlog notes that the AHIP news release was generated in response to the Affordable Care Act marketplace subsidy controversy and 2020 was an outlier year for all health insurers as it was the first year of the Covid pandemic. Health plans did make MLR rebates in that year according to CMS.

Monday report

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

From Washington, DC,

  • OPM’s leadership posted an end of the year letter to OPM employees.
  • STAT News reports,
    • “Drug manufacturers and pharmacy benefit managers received a holiday gift from President Trump on Friday: They still will not have to publicly post the actual prices of prescription drugs, more than five years after federal law required them to do so.
    • “Net drug prices — the amounts that health insurance companies and PBMs pay to drugmakers, after factoring in rebates — are highly valuable data that undergird the entire economic foundation of the U.S. pharmaceutical industry. But the decision from the Trump administration, rolled out in a new proposed rule, means that drug pricing data will likely remain locked out of public view for the foreseeable future.”
  • Avalere Health shares its perspective about December 2025 Advisory Committee on Immunization Practices Insights and 2026 Emerging Priorities.
    • “The ACIP’s December meeting resulted in a key change to the pediatric immunization schedule and signaled several potential changes to US vaccine coverage and access in 2026.”
  • Per an HHS news release,
    • “Executing on President Trump’s Executive Order (EO) 14192 titled “Unleashing Prosperity through Deregulation” and the President’s mandate to ensure the United States’ continued leadership in artificial intelligence (AI), the U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), today released the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule.
    • “Today’s HTI-5 Proposed Rule has three core goals: (1) reducing burden on health IT developers by streamlining ASTP/ONC’s voluntary Health IT Certification Program by removing redundant requirements; (2) updating the information blocking regulations to better promote electronic health information access, exchange, and use so that patients’ access to their data is not blocked; and (3) advancing a new foundation of Fast Healthcare Interoperability Resources (FHIR®)-based application programming interfaces (APIs) that promote AI-enabled interoperability solutions through modernized standards and certification. The HTI-5 proposed rule is expected to save $1.53 billion in total, including $650 million over the next five years for health IT developers, providers, and other stakeholders.
    • “The HTI-5 proposed rule delivers on President Trump’s directive to reduce regulatory burden and to enable American innovation through artificial intelligence,” said Tom Keane, MD, Assistant Secretary for Technology Policy and National Coordinator for Health IT. “These proposals reflect a commonsense approach that removes redundant requirements on health IT developers, that better ensures seamless patient access to their information and that sets a foundation for AI-based data exchange.” * * *
    • “More information can be found at healthit.gov/hti5 and via ASTP/ONC’s X account, @HHS_TechPolicy
    • “ASTP/ONC is also withdrawing certain proposals not yet finalized from the HTI-2 proposed rule.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “U.S. regulators approved the first GLP-1 weight-loss pill—a tablet formulation of Novo Nordisk’s NOVO.B  Ozempic and Wegovy—ushering in a new era of the obesity-drugs revolution that is expected to broaden their use.
    • “Novo Nordisk said it plans to start selling the new pill in the U.S. soon after the new year, with a cash price of $149 a month for the starting dose.
    • “The Food and Drug Administration approval is a milestone because weekly shots such as Wegovy and Eli Lilly’s LLY Zepbound have dominated the anti-obesity market to date. Yet many people with excess weight don’t take the shots due to cost, spotty insurance coverage and fear of needles.
    • “Drug companies and analysts say pills will tap in to demand from people who don’t want an injection or would prefer the cadence of a daily dose. Pills also offer the prospect of lower prices and better health-insurance coverage than injections, because pills cost less to make.
    • “Eli Lilly also plans to introduce a new weight-loss pill, potentially within weeks or months.” 
  • Fierce Pharma tells us,
    • “Just two months after reviving its prowess in the idiopathic pulmonary fibrosis (IPF) treatment area with rare lung disease med Jascayd, Boehringer Ingelheim is already unlocking another patient population with a new FDA nod.
    • “The new approval for Jascayd in progressive pulmonary fibrosis (PPF) makes the drug the only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication, according to a Dec. 19 company press release.
    • “Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need. The U.S. approval of Jascayd is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option,” Boehringer’s head of human pharma, Shashank Deshpande, said in a release.”
  • MedTech Dive notes,
    • “Abbott said Monday that it has received Food and Drug Administration approval for its Volt pulsed field ablation system.
    • “The catheter-based device uses targeted, high-energy electrical pulses to treat a common heart arrhythmia called atrial fibrillation. Abbott’s Volt device is indicated for both paroxysmal AFib, where episodes come and go, and persistent AFib, or episodes that last longer than seven days, according to the FDA.
    • “Medtronic, Boston Scientific and Johnson & Johnson have all debuted their own PFA devices in the last two years. The approval allows Abbott to join the fast-growing, competitive market in the U.S.”

From the public health and medical / Rx research front,

  • The American Medical Association lets us know “What doctors wish patients knew about family immunizations.”
    • “Vaccines save millions of lives each year. Two infectious diseases physicians discuss the key role they should play for the loved ones in your family.”
  • Health Day informs us,
    • “Psychiatric conditions as varied as schizophrenia and bipolar disorder might be driven by very similar genetic underpinnings, a new study says. 
    • “Mental health problems can be sorted into five general genetic categories, each with a shared “genetic architecture” driving people’s illness, according to results published in the journal Nature.
    • “Right now, we diagnose psychiatric disorders based on what we see in the room, and many people will be diagnosed with multiple disorders. That can be hard to treat and disheartening for patients,” lead researcher Andrew Grotzinger, an assistant professor of psychology and neuroscience at the University of Colorado-Boulder, said in a news release.
    • “This work provides the best evidence yet that there may be things that we are currently giving different names to that are actually driven by the same biological processes,” he said.”
  • and
    • “A new risk score can help predict which pancreatic cancer survivors are more likely to suffer a recurrence of their cancer, researchers said.
    • “The score could help better manage the follow-up care for patients who’ve had pancreatic tumors surgically removed, and whose cancers have not spread to their lymph nodes, researchers wrote Dec. 17 in JAMA Surgery.
    • “We now have a way to identify patients whose higher risk of recurrence may have been previously overlooked,” senior researcher Dr. Cristina Ferrone, chair of surgery at Cedars-Sinai Medical Center in Los Angeles, said in a news release. “This gives us the opportunity to change the way we care for this patient population in a meaningful way.”
    • “The score helps people with pancreatic neuroendocrine tumors, which are a less common and typically less aggressive form of pancreatic cancer.
    • “Patients whose cancer has not spread outside the pancreas, to either the lymph nodes or surrounding organs, have a 91% five-year survival rate following surgery, researchers said in background notes.”
  • The Wall Street Journal relates
    • “For years, Barbara Schmidt’s family feared an illness was behind a pattern of terrifying falls that repeatedly landed the 83-year-old great-grandmother in surgery with broken bones. Instead, Schmidt’s frequent tumbles might have been tied to something else: medications intended to make her better.
    • “Schmidt, who lives with her husband of 65 years in Lewes, Del., filled prescriptions for more than a dozen different drugs in the past year, according to pharmacy and medical records.
    • “That isn’t unusual for America’s seniors, according to a Wall Street Journal analysis of Medicare data. One in six of the 46 million seniors enrolled in Medicare’s drug benefit, which pays for most drugs taken by older Americans, were prescribed eight or more medications.”
    • * * * “Schmidt’s recent prescriptions came from at least five different healthcare providers. Most were affiliated with the nearby hospital system Beebe Healthcare, including a nurse practitioner whom she sees for primary care and a gastroenterology office. An orthopedic surgeon who has treated her back problems and prescribed medications to help with her pain works for an independent practice, First State Orthopaedics. 
    • “A Beebe spokesman said it has reviewed its prescribing patterns and, this November, added a new electronic medical record that will allow doctors to “view consolidated medical and medication histories” for patients and deliver “safer, more informed care.” First State Orthopaedics said it doesn’t comment on matters of patient care unless it is legally required to do so.
    • “Pharmacists who work with seniors say doctors might not be aware of their patients’ full medication list. Patients don’t always mention what their other doctors have prescribed when a history is taken, and specialists might not have access to a shared medical record.
    • “The Journal analysis found that, among seniors taking eight or more drugs, it was common for the prescriptions to come from a large number of doctors.”

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

  • Per Beckers Hospital Review,
    • “Houston-based Nutex Health has opened its 26th micro-hospital, Archview ER & Hospital, in St. Louis.
    • “The 16,000-square-foot facility includes 15 emergency room beds, three inpatient suites, a full-service laboratory and advanced imaging technology, according to a Dec. 22 Nutex Health news release.
    • “It replaces Homer G. Phillips Memorial Hospital, which surrendered its license and closed in March. The hospital had been temporarily closed since December 2024, when its license was suspended due to a blood supply shortage.”
  • and
    • “Mark Cuban Cost Plus Drug Co. has added Vegzelma, a biosimilar indicated for six cancer types, to its marketplace for hospitals and other healthcare providers. 
    • “The company plans to expand its biosimilar offerings amid growing demand for biologics among health systems, according to a news release shared with Becker’s. Cost Plus Drugs also offers Starjemza, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab), at a price about $3,000 lower than retail at other pharmacies.
    • “Vegzelma is a biosimilar to Roche’s Avastin (bevacizumab), which is approved for treatment of metastatic colorectal cancer; non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.”