Midweek update

ACA

Midweek update

David Ermer–ACA, CMS, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor added another post to his excellent Secrets of OPM blog today. This one is titled “Simplicity is a Virtue.” In the FEHBlog’s opinion, OPM should focus on simplifying its administration of the FEHB and PSHB programs.
  • The FEHBlog noticed on the following rulemakings currently under Office of Management and Budget review:
  • The FEHBlog is concerned about the OPM rule because OPM has not implemented the HIPAA 820 electronic enrollment roster transaction that would allow carriers to reconcile individual enrollees with their premiums. What is the sense of having a pristine family member list without knowing whether the enrollee is paying the correct premium. The HIPAA 820 also would give carriers earlier notice about enrollees who have left federal employment and annuitants who have passed away.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the 2026 KidneyX EMPOWER Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them. To further enhance nephrology care, HHS will also support data standardization and health information technology improvements across the kidney care ecosystem. The challenge will be run through the Kidney Innovation Accelerator (KidneyX).”
  • The Wall Street Journal reports,
    • “One in seven people who signed up for Affordable Care Act plans this year failed to pay after premium costs rose sharply, according to an analysis that provides the first comprehensive look at the impact of expiring federal subsidies. 
    • “Nationally, around 14% of those who enrolled in ACA plans this year didn’t pay their first monthly bill for January coverage. In some states, the share was a quarter or more, according to a new analysis from the actuarial firm Wakely Consulting Group, provided exclusively to The Wall Street Journal.
    • “It’s a big drop,” said Michelle Anderson, a Wakely consulting actuary. 
    • “Normally, the rate of falloff in ACA plan membership early in the year is in the midsingle-digit range.”

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “The Food and Drug Administration is taking the first step toward potentially allowing compounding pharmacies to produce seven peptides that are currently restricted because of the agency’s previous warning over safety concerns.
    • “The agency’s expert advisory panel on pharmacy compounding is scheduled to discuss whether the peptides should be used in compounding for purposes for ulcerative colitis, wound healing, inflammatory conditions, obesity, insomnia and more, according to a Federal Register notice posted Wednesday announcing a late-July meeting.”

From the judicial front,

  • Bloomberg Law reports,
    • “A federal appeals court vacated an order rejecting a request to block a Maryland drug discount law, remanding the decision for review, in a victory for AbbVie Inc., Novartis AG, AstraZeneca Plc, and PhRMA.
    • “The US Court of Appeals for the Fourth Circuit ruled that a lower court “erred” when it denied the drugmakers’ motion for a preliminary injunction against Maryland’s H.B. 1056.
    • “The decision was driven by a recent order from the Fourth Circuit that upheld a block on West Virginia’s version of the contract pharmacy law, with the majority opinion stating that “West Virginia passed a materially similar statute, which this Court recently held is likely preempted”.

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Many scientists have contended that humans have evolved very little over the past 10,000 years.
    • A few hundred generations was just a blink of the evolutionary eye, it seemed. Besides, our cultural evolution — our technology, agriculture and the rest — must have overwhelmed our biological evolution by now.
    • “A vast study, published on Wednesday in the journal Nature, suggests the opposite. Examining DNA from 15,836 ancient human remains, scientists found 479 genetic variants that appeared to have been favored by natural selection in just the past 10,000 years.
    • “The researchers also concluded that thousands of additional genetic variants have probably experienced natural selection. Before the new study, scientists had identified only a few dozen variants.
    • “There are so many of them that it’s hard to wrap one’s mind around them,” said David Reich, a geneticist at Harvard Medical School and an author of the new study.” * * *
    • “Nandita Garud, a geneticist at the University of California, Los Angeles, who was not involved in the new study, said that unearthing natural selection over the past 10,000 years could do more than just illuminate our deep history.
    • “Scientists still don’t know much about how genetic variations influence our health. When they find a link between a genetic variant and a disease, Dr. Garud said, it will be important to see whether it has been favored by natural selection.
    • “That might give you a clue that this is important,” she said.”
  • The Wall Street Journal relates,
    • “Vertigo and dizziness, often caused by dislodged inner-ear crystals (BPPV), are common age-related problems increasing fall risk.
    • “Emergency-room visits for vertigo commonly result in unnecessary diagnostic tests and sedative medications, potentially worsening patient outcomes.
    • “Researchers are investigating links between BPPV and migraines, low vitamin D, and osteoporosis, while developing new rehabilitation treatments.”
  • Fierce Healthcare tells us,
    • “Behavioral health utilization increased substantially from 2018 to 2024, with anxiety disorder care fueling much of that growth, according to Trilliant Health. 
    • “The health data analytics and market research firm’s latest report outlines a 62.6% jump in behavioral health utilization, based on any visit associated with a behavioral health diagnosis code.
    • “Between 2008 and 2024, the prevalence of mental illness increased by almost 6 percentage points. About a quarter of adults had any mental illness in 2024, Trilliant found, though in adults 18-25 exhibit the highest prevalence both in terms of any mental illness (33%) and serious mental illness (16%). 
    • “Anxiety disorders accounted for the highest visit volume and experienced the fastest growth, up 89% from 2018 to 2024. Anxiety disorders in women aged 18-44 were also the highest utilization category in 2024. 
    • “It’s possible those figures are increasing because more screening is happening, acknowledged Trilliant Health Chief Research Officer Allison Oakes, Ph.D.”
  • Medscape adds,
    • “Utah’s pilot program using AI for psychiatric medication refills raises safety and compliance concerns. Critics argue it lacks transparency, proper research, and may violate FDA laws, emphasizing the need for licensed physician oversight.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Studying mice, researchers at Toronto’s Sinai Health have found that semaglutide—the active ingredient in popular weight loss drugs that mimic the gut hormone GLP-1—acts directly on a subset of liver cells to improve organ function, and does so independently of weight loss. The finding challenges long-held assumptions about how GLP-1 medicines work in the liver and could reshape how physicians treat metabolic liver disease.
    • “Headed by Daniel Drucker, MD, a senior investigator at the Lunenfeld-Tanenbaum Research Institute, the team reported on their findings in Cell Metabolism, in a paper titled “The weight-loss-independent hepatoprotective benefits of semaglutide are orchestrated by intrahepatic sinusoidal endothelial GLP-1 receptors.”\
  • Per Multiple Sclerosis News,
    • “People with diabetes are significantly more likely — with nearly 60% higher odds — to develop multiple sclerosis (MS) than those without the metabolic disease, which is marked by high blood sugar levels, according to a new systematic review and meta-analysis.
    • “A significant association was also observed specifically between type 2 diabetes, the most common form of the condition, and MS risk.
    • “The analysis did not, however, find clear evidence that MS increases the likelihood of developing diabetes.
    • “Current evidence indicates that [diabetes mellitus], specifically [type 2 diabetes], increases the risk of developing MS,” the researchers wrote. “However, a reverse association remains unconfirmed.”
  • Per MedPage Today,
    • “Primary care patients educated about Alzheimer’s disease blood-based biomarkers were generally willing to undergo tests and supported their use, survey data showed.
    • “After patients received a brief explanation of Alzheimer’s blood tests, 94.5% supported offering them to patients with memory complaints, and 85% said they were willing to complete a test if their clinician recommended it, reported Andrea Russell, PhD, of Northwestern University Feinberg School of Medicine in Chicago, and co-authors.
    • “Patients endorsed Alzheimer’s blood tests when they informed medical care (94.2%), were covered by insurance (93.4%), if comprehensive education was received prior to testing (88.5%), and if testing was easy or convenient (88.1%), Russell and colleagues wrote in Alzheimer’s & Dementiaopens in a new tab or window.”
  • Healio adds,
    • “High vitamin D levels in mid-life were associated with lower levels of tau protein in the brain more than a decade later, suggesting a possible modifiable risk factor for Alzheimer’s disease, according to findings in Neurology Open Access.
    • “Previously, it was known that low circulating vitamin D in later life is associated with an increased risk of cognitive impairment and clinical dementia,” Martin D. Mulligan, MBBCh, BAO, a researcher at the University of Galway in Ireland, told Healio.
    • “Most prior studies evaluating the association between vitamin D and cognitive function typically measured circulating vitamin D in older adults,” he continued. What our study adds is a focus on early mid-life.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “The increasing cost of medical care is driving more workers to forgo needed care or stop taking medications, ADP found in a recently released employee benefits survey. 
    • “Twenty-six percent of respondents said they’d skipped needed medical care for themselves or a family member due to out-of-pocket costs (compared to 21% in 2020), 22% have stopped taking or taken less medication (compared to 17% in 2020), and 15% declined vision or dental insurance so they could afford medical insurance. 
    • “The finding “points to the need for simpler plan design, clearer education and flexible options that reflect different budget preferences,” ADP observed. “Employers can play a stronger role in helping employees make cost-conscious choices without compromising care.”
  • Fierce Healthcare relates,
    • “Average physician pay rose about 3% between 2024 and 2025, from $374,000 to $386,000—outpacing the 2.7% U.S. core inflation rate that rounded out the year, a new annual report from Medscape found.
    • “Medscape’s 2026 Physician Compensation Report surveyed 5,916 physicians across more than 29 specialties. Total compensation numbers reflect base salary and incentive bonuses, plus other income sources like profit-sharing contributions, as reported by full-time physicians.
    • “Matthew Wells, Ph.D, a senior director at AGMA Consulting, called 2025 a “return to normalization” for physician compensation in the report and expects “consistency with increases” in the future. Driving factors cited by Wells include physician productivity in seeing more patients and improved technology-driven efficiency. 
    • “Fifty-three percent of all physicians report feeling fairly compensated, as opposed to last year’s report in which only 48% reported fair compensation—what the report notes was the “most dispirited response” it had seen in a decade of posing the question.” 
  • Beckers Hospital Review offers a non-exhaustive list of “32 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
  • and lets us know,
    • “The Illinois Health Facilities and Services Review Board approved Ontario, Calif.-based Prime Healthcare’s acquisition of Franciscan Health Olympia Fields (Ill.). 
    • “The 214-bed hospital is expected to transition to Prime on May 1, according to an April 14 news release shared with Becker’s. 
    • “Prime Healthcare entered an agreement in January to acquire the hospital and and Specialty Physicians of Illinois from Mishawaka, Ind.-based Franciscan Alliance. Prime said it plans to offer jobs to “substantially all employees” at Olympia Fields. 
    • “Olympia Fields is set to become Prime’s ninth Illinois hospital and 55th overall. In March 2025, the health system acquired eight Illinois facilities from St. Louis-based Ascension. Prime said that in the first year of ownership, it invested more than $104 million in the eight hospitals to enhance clinical care and operations, modernize infrastructure and expand service lines.” 
  • BioPharma Dive informs us,
    • “Beeline Medicines emerged from stealth Wednesday with plans to develop “precision therapies” for immune diseases, nearly a year after its backer Bain Capital teamed up with Bristol Myers Squibb to give five of the pharma’s experimental medicines a new home.
    • “Beeline’s pipeline is led by the licensed drug afimetoran, a daily oral treatment for systemic lupus erythematosus, a form of lupus, that targets a pair of receptor proteins which are responsible for regulating the immune system. At Bristol Myers, the drug had already been tested in a Phase 1b trial in a different form of lupus. A Phase 2 study is underway and is expected to be completed in the second half of this year, after which Beeline plans to launch “a pivotal development program.”
  • MedTech Dive adds,
    • “Avanos Medical has accepted a $1.27 billion go-private offer from American Industrial Partners, the company said Tuesday. 
    • “AIP agreed to pay a 72.1% premium to Avanos’ closing stock price on Monday. Avanos CEO Dave Pacitti told customers that AIP will back his company to strengthen its competitive position.  
    • “Avanos competes with businesses including Boston Scientific and Cook Medical for the specialty nutrition market, and rivals such as Medtronic and Stryker in the pain management space.”

Monday report

David Ermer–ACA, CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–
  • Happy National Doctors’ Day!
    • “National Doctors’ Day is a nationwide observance dedicated to honoring physicians for their expertise, responsibility, and continued commitment to patient care. Observed annually on March 30, it creates a natural point of recognition for the role doctors play in the health and well-being of individuals, families, and communities, often during critical and life-changing moments.”

From Washington, DC.

  • Roll Call reports,
    • “President Donald Trump wants Congress to nix a two-week recess and return to the Capitol to address the ongoing Department of Homeland Security shutdown, his top spokesperson said Monday.
    • “The president is also encouraging Congress to come back to Washington to permanently fix this problem and to fund and reopen the Department of Homeland Security entirely,” White House press secretary Karoline Leavitt told reporters.”
  • Govexec adds,
    • “Most Transportation Security Administration officers received a paycheck Monday covering four weeks of back wages that were held up by the funding lapse at the Homeland Security Department, a TSA spokesperson said, [due to an Executive Order].
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM), in partnership with the White House, today announced the launch of a new Early Career Talent Network designed to connect emerging professionals with full-time career opportunities across the federal government.
    • “The new network, available at EarlyCareers.gov, will help build a stronger pipeline of talent into critical mission roles across government, including finance, human resources, engineering, project management, and procurement. The initiative supports broader administration efforts to modernize federal hiring and strengthen the next generation of public servants.
    •  “Building a strong pipeline of early-career talent is essential to the future of the federal workforce,” OPM Director Scott Kupor said. “We are making it easier for talented individuals to connect with meaningful careers in public service while helping agencies efficiently identify the talent they need to deliver results for the American people.”
  • OPM Director Scott Kupor made another management-oriented post to his Secrets of OPM blog now available on Substack. The post discusses the Earlycareers.gov initiative.
  • The American Hospital Association News tells us,
    • “Average out-of-pocket premiums for Health Insurance Marketplace enrollees increased $65 per month in 2026 compared to 2025, going from $113 to $178, according to a report released March 27 by the Centers for Medicare & Medicaid Services. The figures represent costs after accounting for the enhanced premium tax credits, which expired at the end of 2025. CMS also found that 40% of 2026 enrollees selected bronze plans, up from 30% in 2025. Silver plan selection dropped from 56% to 43%, while gold plan selection increased from 13% to 17%. Additionally, CMS said 23.1 million consumers selected or re-enrolled in Marketplace coverage for 2026, marking a 5% decrease from 2025.” 
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) today has chosen 15 scientific teams from across the nation as cash prize winners for their submissions to a national crowdsourcing challenge designed to generate innovative ideas that integrate diet and nutrition into autoimmune disease research. Winning submissions investigated the effectiveness of dietary interventions; microbiome, immune system and multi-omic approaches; personalized and data-driven predictive nutrition; and community and patient-center research frameworks. 
    • “Autoimmune diseases affect more than 8% of the U.S. population, impacting between 23 and 50 million Americans. Despite the prevalence and significant economic burden of autoimmune diseases, the role of diet and nutrition in this area remains largely underexplored. NIH invited researchers, clinicians, patients, caregivers, advocacy groups, and interdisciplinary teams to submit feasible, scalable approaches to better understand how dietary interventions may influence autoimmune disease onset, progression, flares, and symptom management. 
    • “The challenge, known as the Nutrition for Our Immune System Health (NOURISH): Autoimmunity Challenge and led by NIH’s Office of Autoimmune Disease Research, yielded many highly competitive submissions, and resulted in 15 prize awards, totaling $10,000 to each team. The winners showed thoughtful planning and designs that, with further development, could result in innovative solutions to benefit Americans affected by autoimmune diseases. Each winning entry contributed innovative, scientifically rigorous, and patient-centered ideas to advance the science of autoimmune disease research and care in one of four thematic areas.”
  • and
    • “The National Institutes of Health (NIH) announced that Elisabeth Armstrong, DBe, has been named chief of staff in the NIH Office of the Director.  As chief of staff, Dr. Armstrong will oversee the Office of the Director. She will provide strategic counsel to the NIH Director and other key leaders within NIH, in addition to managing process, operations, and information flows.    
    • “Dr. Armstrong is an outstanding addition to NIH’s leadership team. Her unique background and range of public and private sector experience will help drive positive action and innovation at NIH,” said NIH Director Jay Bhattacharya, M.D., Ph.D.” 

From the Food and Drug Administration front,

  • BioPharma Dive points out five FDA decisions to watch in the second quarter of 2026, which starts on Wednesday.
  • Per Fierce Pharma,
    • “With a second phase 3 win for Tyvaso in idiopathic pulmonary fibrosis (IPF), United Therapeutics is padding the case for an expansion and putting more color on its filing plans with the FDA. 
    • “In the wake of the “overwhelmingly positive” pair of late-stage readouts, multiple analysts are sharing in United’s optimism that Tyvaso (treprostinil) could change the treatment landscape in the lung scarring disease, which is estimated to affect more than 100,000 people in the U.S.” 
  • MedTech Dive reports,
    • “Medtronic has received 510(k) clearance for its Stealth AXiS surgical system for cranial and ear, nose and throat procedures.
    • “The clearances, which Medtronic disclosed Friday, expand the label of a system that combines surgical planning, navigation and robotics to improve surgeons’ workflows.
    • “Medtronic said cranial surgeons can use the system to create patient-specific brain maps, while the benefits for ENT teams include visualization tailored to the sinuses and skull base.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “A “highly mutated” COVID variant that flew under the radar for years has been detected in a growing number of U.S. states, health officials said this week.
    • “The Centers for Disease Control and Prevention (CDC) said in a March 19 report that it was tracking variant BA.3.2, nicknamed “Cicada,” after routine surveillance noted an increase in U.S. cases. The World Health Organization (WHO) likewise listed the strain on its “variants of monitoring” record, as it has been detected in at least 23 countries.
    • “Cicada still accounts for only a small number of cases in the United States, but has ballooned to represent up to 30% in some European countries. Still, the CDC said its monitoring of the spread “provides valuable information about the potential for this new SARS-CoV-2 lineage to evade immunity from a previous infection or vaccination.” * * *
    • “The CDC’s latest data from Feb. 11 used wastewater collected by its National Wastewater Surveillance System and Stanford University’s WastewaterSCAN Dashboard. A pathogen’s existence and prominence can be measured by testing wastewater samples collected from sources such as sewage, industrial waste and stormwater runoff.
    • “The testing tracked the presence of BA.3.2 in 25 states, including: California, Connecticut, Florida, Hawaii, Idaho, Illinois, Louisiana, Maine, Michigan, Maryland, Massachusetts, Missouri, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Vermont, Virginia and Wyoming.”
  • Stony Brook (NY) Medicine adds,
    • “The Cicada variant (BA.3.2) is a newer Omicron-related subvariant identified through global and U.S. monitoring systems. Like other recent strains, it has evolved with mutations that may influence how easily it spreads and how the immune system responds.” * * *
    • “Overall, while the Cicada variant may contribute to seasonal increases in cases, it does not currently appear to dramatically change the risk landscape.
    • “Health experts say that the BA.3.2 “Cicada” variant doesn’t seem to cause any new or unusual symptoms compared to other Omicron COVID‑19 variants. Right now, health organizations are mostly tracking how the virus spreads and changes, rather than listing new symptoms.”
  • The Wall Street Journal relates,
    • “Measuring cholesterol levels has long been the main way doctors assess the risk of heart disease. Increasingly, people are opting, too, for a simple, relatively affordable test: a coronary artery calcium scan, or CAC.
    • “The tests recently got a boost from influential clinical guidelines issued earlier this month by leading cardiology groups. These guidelines also included, for the first time, recommended levels of LDL—known as low-density lipoprotein or “bad” cholesterol—based on calcium scores from the scans.
    • “Why does this matter to you? The more calcium you have in your heart, the lower your LDL cholesterol should be to help reduce your risk of having a heart attack or stroke. So the scans give doctors and patients a more precise picture of your risk and whether you need to take action.”
  • The American Medical Association lets us know “what doctors wish patients knew about the deadly risk of stroke.”
    • “Every 40 seconds, someone in the U.S. has a stroke, which is a medical emergency that demands swift action. Meanwhile, every three minutes and 14 seconds, someone dies of stroke in this country. Stroke is the fifth leading cause of death in the U.S. and a major cause of long-term disability for adults, but it is preventable and treatable. That is why patients and families need to know more about preventing and identifying stroke. 
    • “More than 795,000 people in the U.S. have a stroke every year. About 610,000 of these are first or new strokes. Meanwhile, nearly 25% of strokes are in people who have had a previous stroke. And about 87% are ischemic strokes in which blood flow to the brain is blocked, according to the Centers for Disease Control and Prevention (CDC).”
  • Health Day tells us,
    • “For parents of a child with obesity, a normal lab report from the pediatrician may suggest that their weight isn’t yet a problem.
    • “But even if the child’s blood pressure is steady and their sugar levels are fine, those encouraging results — called metabolically healthy obesity or MHO — might be a deceptive snapshot of a much riskier future.
    • ‘Researchers at the Karolinska Institute in Sweden followed more than 7,200 children aged 7 to 17 who were in treatment for obesity. They were followed until age 30. 
    • “Over that period, researchers compared those with metabolically healthy test results to those with early warning signs, and to a control group of more than 35,000 from the general population.
    • ‘The study published March 23 in JAMA Pediatrics found that even kids with MHO — meaning they had normal blood pressure, liver values and blood fats — were at a disadvantage compared to their peers over the long term.”
  • CNN informs us,
    • “Calls to poison centers in the United States about the widely available herb kratom increased more than 1,200% between 2015 and 2025, new research has found.
    • “This data reflects a concerning trend,” study coauthor Dr. Christopher Holstege , director of the Blue Ridge Poison Center at the University of Virginia, said in a news release.
    • “The research was published Thursday in the US Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
    • “Kratom is an herb from the leaves of the tropical tree Mitragyna speciosa native to Southeast Asia. It has both stimulant and sedative effects and carries a risk of addiction due to how it interacts with the brain, Dr. Oliver Grundmann , a leading kratom researcher and clinical professor in the department of medicinal chemistry at the University of Florida, told CNN in an August story.
    • “The psychoactive herb isn’t federally regulated and thus isn’t “lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food,” according to the US Food and Drug Administration. But in states that haven’t banned kratom, it’s sold at gas stations, smoke shops and convenience, grocery and health food stores in various forms, including powders, loose-leaf teas, capsules, tablets and concentrates. Some states allow people of any age to buy it.”
  • Neurology Advisor notes,
    • “Among multiple healthy dietary patterns, higher adherence to the DASH diet was associated with the greatest reduction in risk for subjective cognitive decline, supporting diet quality as a modifiable factor for cognitive health.”
  • Per Fierce Pharma,
    • “After notching a phase 2 trial win, Idorsia’s insomnia med Quviviq (daridorexant) is one step closer to potentially becoming a first-in-class treatment for children.
    • “The drug, a dual orexin receptor antagonist (DORA), was studied in children with insomnia between the ages of 10 and 17 years old, including those with neurodevelopmental disorders such as autism spectrum disorder and attention-deficit/hyperactivity disorder (ADHD). 
    • “As measured through a two-week polysomnography sleep study, 165 patients who received a 10-, 25- or 50-mg dose of Quviviq experienced dose-dependent improvements in total sleep time from baseline, Idorsia reported on Monday.”
  • Per MedTech Dive,
    • “Boston Scientific’s Watchman FLX left atrial appendage closure device worked as effectively as blood thinners to lower stroke risk and death at three years in patients with non-valvular atrial fibrillation, study data unveiled Saturday showed.
    • “The study also demonstrated a 45% relative reduction in non-procedural bleeding risk in patients who received the Watchman FLX implant. The findings of the closely watched CHAMPION-AF clinical trial were presented at the American College of Cardiology’s annual meeting and published in the New England Journal of Medicine.
    • “The 3,000-patient study met all of its safety and efficacy endpoints. Boston Scientific said it will seek to expand the indication and Medicare coverage for the device as a first-line stroke risk reduction option based on the results.

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

  • Beckers Hospital Review reports,
    • “Cigna’s Express Scripts continued its lead in the U.S. pharmacy benefit manager market for the second year in a row, processing nearly one-third of all prescription claims, according to a March 30 report from the Drug Channels Institute.
    • “The PBM handled 31% of total equivalent prescription claims last year, up from 30% in 2024. CVS Caremark, which dominated the sector until 2024, saw its share fall to 26% amid volume losses tied to major client transitions. Optum Rx, a subsidiary of UnitedHealth Group, maintained a 23% share for the second straight year.
    • “Despite ongoing scrutiny from regulators and rising competition from smaller firms, the same three PBMs as last year still control 80% of the market.
    • “The rankings are based on Drug Channels Institute’s analysis of total equivalent prescription claims processed across the industry.”
  • and
    • “CVS Pharmacy will open its first pharmacy-only location in Chicago on March 30.
    • “The store, located at 2628 W. Pershing Road in the city’s West End, is part of a planned rollout of nearly 20 pharmacy-only, apothecary-style CVS Pharmacy locations expected to launch in select communities in 2026, according to a March 24 statement from CVS shared with Becker’s. The format reflects CVS’ shift toward smaller, pharmacy-focused stores amid declining retail sales.
    • “CVS is in the early stages of launching the new model, the first locations under which will average less than 5,000 square feet — about half the size of a traditional CVS store. The sites will stock health-related products but exclude general consumer goods like greeting cards and groceries.
    • “The launch comes as CVS repositions its pharmacy footprint. The company closed 270 locations in 2025 but plans to open nearly 100 new sites, including more than 60 acquired from Rite-Aid. According to CVS Health’s October 2025 “Rx Report,” 80% of patients prefer in-person pharmacy care and 84% view pharmacies as credible sources of healthcare. The small-format stores aim to meet these expectations while expanding access in underserved areas.”
  • BioPharma Dive relates,
    • “Obesity drugmaker Kailera Therapeutics plans to test investor appetites for another biotechnology initial public offering, according to a Friday securities filing.
    • “If successful, the company, which has several experimental weight loss medicines in testing, could join a short list of newly public biotechs that have raised more than $1.7 billion in proceeds so far this year.
    • “Kailera’s most advanced prospect, ribupatide, is a weekly GLP-1/GIP agonist in late-stage testing. So far, Kailera and its partner Hengrui Pharma have published data from a 48-week Phase 3 trial in Chinashowing that ribupatide helped people with obesity, on average, lose 18% of their body weight.
    • “The drugmaker expects to publish data from an earlier study of an increased dose next year, and findings from its global Phase 3 study in 2028.”
  • A MedCity News opinion piece explains why
    • “AI Can Expand Access to Healthcare — But Only With Human Action
    • “Health systems can turn insights into action, ensuring that preventive care actually happens by combining accurate risk prediction with human outreach and careful planning.”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of lorundrostat (Mineralys Therapeutics, Inc.) and baxdrostat (AstraZeneca) for hypertension.
    • “The assessment will be publicly discussed during a meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in October 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
    • “Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including relevant patient groups, the manufacturers, and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.  
    • “All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to publiccomments@icer.org and must be received by 5 PM ET on April 17, 2026.”

Midweek report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Senate negotiators said an effort to renew expired healthcare subsidies had effectively collapsed, likely ending the hopes of 20 million Americans that the tax-credit expansion could be revived and lower their monthly insurance premiums.
    • “Talks had centered on a proposal from Sens. Bernie Moreno (R., Ohio) and Susan Collins (R., Maine) to extend a version of the enlarged Affordable Care Act subsidies for at least two years, while cutting off higher-income people from participating and eventually giving enrollees the option of putting money into health savings accounts. It also would eliminate zero-dollar premium plans. But lawmakers from both parties now say the chances of a deal have all but evaporated.
    • “It’s effectively over,” Moreno said Wednesday. Sen. Bill Cassidy (R., La.)—the architect of an adjacent plan—agreed. While Collins declined to be as definitive, she did say that it was “certainly difficult.”
  • Federal News Network tells us,
    • “Following a year of the Trump administration’s overhauls to the civil service, a bicameral group of lawmakers on Wednesday launched a congressional caucus focused on the federal workforce.
    • “Sens. Chris Van Hollen (D-Md.) and Tim Kaine (D-Va.), along with Reps. James Walkinshaw (D-Va.), Steny Hoyer (D-Md.) and Suhas Subramanyam (D-Va.) joined federal unions and good government organizations to announce the newly formed Federal Workforce Caucus. The group aims to more cohesively advocate for federal employees.” * * *
    • “Members of the new Federal Workforce Caucus, which includes at least some bipartisan support, are expected to meet regularly with leaders from federal unions, employee groups and other organizations. The group plans to propose legislation and workforce policies focused on long-term improvements to the career civil service.
    • “The Partnership for Public Service, American Federation of Government Employees, National Federation of Federal Employees and National Active and Retired Federal Employees Association, among several others, are also partners in the new caucus.”
  • OPM Director Scott Kupor has added another post to his Secrets of OPM blog.
  • Per a CMS news release,
    • “CMS continues to bring accountable care to more people with Medicare in 2026, expanding the benefits of high-quality, whole-person health care to achieve better health outcomes for millions of older Americans.
    • “As of January 2026, 14.3 million Medicare beneficiaries are estimated to receive care coordinated by Accountable Care Organizations (ACOs), up from 13.7 million in 2025, representing a 4.4% increase. This includes patients whose health care providers are in Medicare Shared Savings Program (Shared Savings Program) ACOs and entities participating in Center for Medicare and Medicaid Innovation (CMS Innovation Center) accountable care models, as well as other CMS Innovation Center models focused on total cost of care, advanced primary care, and specialty care.
    • “ACOs are groups of doctors, hospitals, and other health care providers who collaborate and provide coordinated, high-quality care to people with Medicare, and they are a critical tool to help Make America Healthy Again by supporting whole person care that addresses prevention, chronic illness and the root causes of disease.
    • “In addition to improving health care, ACOs save billions of dollars for the Medicare program by focusing on delivering the right care at the right time while avoiding unnecessary services and medical errors. ACOs achieve savings because health care providers are held accountable for saving money and improving health care quality, delivering a win for both patients and the Medicare Trust Funds.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Johnson & Johnson’s Abiomed has sent an urgent medical device correction about a malfunction risk linked to 22 reports of serious injuries.
    • “The Food and Drug Administration, which published an early alertabout the devices on Tuesday, said sensor values in Impella RP heart pumps may drift over time.
    • “Erroneous information on automated Impella controllers has caused users to make inaccurate adjustments to the devices and unnecessary pump exchanges, the FDA said.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors by Abbott Diabetes Care due to incorrect glucose readings that are lower than actual blood glucose levels. The FDA said patients with impacted sensors should immediately discontinue use and dispose of any affected products. Abbott has reported 860 serious injuries and seven deaths associated with the issue since Jan. 7.” 
  • USA Today relates,
    • “A shortage in estrogen patches because of manufacturing issues and some brand discontinuation has been exacerbated by an increase in prescriptions for estrogen since the Food and Drug Administration removed its black-box warning label last fall. The shortage has left women exhausted, frustrated and scrambling each month to call pharmacies for the medicine they need to treat their menopause symptoms.
    • Some women have switched from generic medication to available brand names, which costs them as much as $300 a month and are not covered by insurance. Others have been forced to use a different brand of estrogen each month, leading to inconsistent care. Women have driven 45 miles to pick up a coveted box of the tiny plastic patch they place near their belly button and change twice a week to help with their symptoms, from frozen shoulders to vaginal dryness.”
  • STAT News adds,
    • “Vertex executives warned that Casgevy, its curative treatment for sickle cell disease, would be slow to reach patients. But few expected it to be this slow.
    • “More than two years after its approval, only about 60 patients across the U.S., Middle East, and Europe have been treated with the gene-editing therapy. Specialists at four sickle centers told STAT they’ve been surprised by one of the key stumbling blocks to faster rollout: They can’t collect enough cells to create the treatment.

From the judicial front,

  • Healthcare Dive reports,
    • “The Federal Trade Commission has agreed to what it called a “landmark” settlement with Express Scripts, allowing the company to bow out of the agency’s lawsuit against major pharmacy benefit managers for allegedly inflating the cost of U.S. insulin.
    • “In return, Express Scripts, which is owned by Cigna and is one of the largest PBMs in the country, has agreed to make major changes to its drug benefit designs, including no longer preferring drugs with high list prices on its standard formularies when there are cheaper equivalents and delinking its compensation from the savings it negotiates with drugmakers, the FTC announced Wednesday.
    • “Express Scripts has also agreed to increase transparency, including reporting more data on drug spending and disclosing any kickbacks to brokers that help employers choose PBMs.
    • “Notably, the company also agreed to reshore its group purchasing organization Ascent from Switzerland back to the U.S.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “The measles outbreak in South Carolina has increased to 876 cases, the state’s Department of Public Health reported Feb. 3. Last week, the South Carolina outbreak surpassed last year’s outbreak in Texas, which had 762 cases. The agency said the number of public exposure sites indicates community spread is occurring, increasing the risk of exposure and infection for individuals who are not immune due to vaccination or natural infection. “Vaccination continues to be the best way to prevent measles and stop this outbreak,” the department said.” 
  • MedPage Today informs us,
    • “In this self-controlled case series, myocardial infarction rates were nearly 9 times greater in the week after an RSV-related hospitalization compared with a control period prior to infection.
    • “Stroke rates were more than 7 times higher compared with the control period.
    • “Recent research has suggested that RSV vaccination lowers the risk of cardiorespiratory hospitalizations.”
  • and
    • The effectiveness of last season’s COVID vaccines among immunocompetent adults reached 40% against hospitalization and 79% against invasive mechanical ventilation or death.
    • Those levels of protection were similar among seniors and sustained through 6 months post-vaccination.
    • This study is a reminder that “vaccines still have a role, even in the current epidemiological landscape,” an expert said.
  • Per an NIH news release,
    • The National Institutes of Health (NIH) has opened the East Palestine Train Derailment Health Research Program Office to assess and address the long-term health outcomes stemming from the 2023 train derailment in East Palestine, Ohio. The new office is the hub of a five-year, $10 million research initiative funded by NIH.
    • “Federal research experts will engage directly with the community, coordinate studies, and help enroll residents in federally supported health research through the new office.” * * *
    • Three years ago, on Feb. 3, 2023, a Norfolk Southern freight train derailment involving 38 railcars carrying hazardous chemicals — including vinyl chloride, butyl acrylate, ethylene glycol and benzene residue — resulted in prolonged fires and controlled burns in East Palestine. Several railcars burned for more than two days, and emergency responders conducted controlled burns that raised concerns about the potential airborne release of hydrogen chloride and phosgene.
    • “Local residents reported a range of initial health symptoms, including headaches and respiratory, skin and eye irritation. These reports prompted concerns about potential longer-term effects on maternal and child health, as well as psychological, immunological, respiratory and cardiovascular health.”
    • “This research program is designed to bring rigorous, independent science directly to the community,” said NIH Director Jay Bhattacharya. “By establishing a local presence, we can better engage residents, support enrollment in studies, and ensure the research reflects the real experiences and concerns of the people affected.”
  • Genetic Engineering and BioTechnology News observes,
    • “As drug‑resistant hospital infections continue to rise worldwide, a team of Australian researchers has identified a surprising new bacterial vulnerability: a sugar that only microbes make. By designing antibodies that recognize this sugar, the scientists were able to clear lethal infections in mice—offering a potential new strategy for tackling multidrug‑resistant pathogens.
    • “The work, published in Nature Chemical Biology, describes the development of monoclonal antibodies that target pseudaminic acid, a carbohydrate found on the surface of many dangerous bacteria but absent from human cells. The study, titled “Uncovering bacterial pseudaminylation with pan‑specific antibody tools,” demonstrates that this sugar may serve as a highly selective molecular flag for immunotherapy.”
  • Per Healio,
    • “Once-weekly subcutaneous tirzepatide may not raise risk for depression compared with placebo, according to a post hoc analysis of the SURMOUNT trials.
    • “As Healio previously reported, in January the FDA requested that risk for suicidal ideation and behaviors be removed from labels for liraglutide (Saxenda, Novo Nordisk), injectable semaglutide 2.4 mg (Wegovy, Novo Nordisk) and tirzepatide (Zepbound, Eli Lilly). 
    • “In data published in Obesity, researchers found adults receiving tirzepatide in three SURMOUNT trials did not experience worsening of depression throughout the studies.
    • “The low occurrence of these events with tirzepatide is similar to that observed in pooled analyses of semaglutide 2.4 mg and liraglutide 3 mg, both GLP-1 receptor agonists approved for weight management,” Thomas A. Wadden, PhD, professor of psychology in psychiatry at Perelman School of Medicine, University of Pennsylvania in Philadelphia, told Healio. “The present report provides the first detailed analysis of the risk of these psychiatric events with tirzepatide.”

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

  • BioPharma Dive reports,
    • “Eli Lilly shares jumped early Wednesday after the company reported better-than-expected fourth-quarter revenue and shared higher forecasts for 2026, buoyed by its obesity and diabetes medicines.
    • “Fourth-quarter revenue soared 43% to $19.3 billion, Lilly said Wednesday. That’s 7% above the Wall Street consensus, Leerink Partners analyst David Risinger wrote in a note to clients. Earnings per share beat estimates by 9% and operating income came in 13% higher than analysts expected, he said.
    • “This year, Lilly expects revenue of between $80 billion and $83 billion, with non-GAAP earnings of $33.50 to $35 a share. Analysts had been expecting midpoint forecasts of $78.5 billion for revenue and $33.30 for EPS, according to Risinger.”
  • Fierce Pharma tells us,
    • “Novartis CEO Vas Narasimhan is doubling down on a growth forecast for 2026, even as the Swiss drugmaker’s fourth-quarter results start to show the impact of the “largest patent expiry” in its history. And while a $4 billion revenue hole awaits, Narasimhan insisted that a wave of newer blockbusters will pull the company back into growth by year-end.
    • “The steep patent cliff that Narasimhan was referring to follows the 2025 U.S. entry of generic rivals to heart failure treatment Entresto, blood disorder drug Promacta and cancer therapy Tasigna.”
  • MedTech Dive informs us,
    • “Boston Scientific has been one of the big winners of the pulsed field ablation revolution. Over the past two years, the company has reported strong electrophysiology sales growth — sometimes in the triple digits — and declared itself the clear market leader in PFA.
    • “However, on a Wednesday morning earnings call, analysts questioned executives on the electrophysiology unit’s potential after U.S. sales growth stalled in the fourth quarter compared with the third quarter.
    • “CEO Mike Mahoney told investors that the company remains confident in PFA’s potential, even as the market becomes more penetrated and competition in the space ramps up. Mahoney said that the electrophysiology market should grow about 15% in 2026, and the company expects to grow above that rate.
  • Beckers Clinical Leadership notes,
    • [Nurse] workforce projections from HHS’ Health Resources and Services Administration indicate “the gap between the demand for and supply of RN services is expected to shrink over the next decade from 10% in 2027 to 6% in 2037,” according to a January report from the council. 
    • “This forecast is partly due to an increase in first-time examinees of the National Council Licensure Examination, according to the report. 
    • “By comparison, the U.S. supply of licensed practical nurses and licensed vocational nurses is projected to decrease a whopping 36% by 2037, HRSA data shows. These workforces have declined in labor participation and absolute licensure statistics across most states, the report said. 
    • “Although the projected outlook for the RN workforce is more favorable than it is for LPNs/LVNs, maldistribution of providers remains a critical issue, with nonmetropolitan areas projected to face significantly higher shortages than metropolitan areas in the coming years,” the report said. “These issues exacerbate the broader projected shortfall owing to the dual trends of increasing demand due to an aging population and an aging workforce.”
  • Cardiovascular Business lets us know,
    • “Early adopters have been using robotics to perform cardiac surgeries in the United States for years now, but multiple factors—including high costs and early concerns about patient outcomes—have held back widespread implementation.   
    • “According to a new commentary in The Annals of Thoracic Surgery, however, robotic cardiac surgery has gained considerable momentum in the last year. Is now the time for this trend to truly take off?
    • “A convergence of improved training frameworks, maturing technology and increasingly standardized quality processes have supported a broader and more sustainable growth,” wrote co-authors Andrea Amabile, MD, a cardiothoracic surgery resident with the University of Pittsburgh Medical Center (UPMC) Heart and Vascular Institute, and Johannes Bonatti, MD, director of the cardiac robotic surgery at the UPMC Heart and Vascular Institute. “In this context, the past year has brought forward a set of notable global milestones that collectively illustrate the evolving capabilities of robotic cardiac surgery.”
  • Per Beckers Health IT,
    • “KLAS Research released its annual “Best in KLAS” report Feb. 4, ranking healthcare technology vendors and service providers across more than 140 market segments based on feedback from the clinicians and administrators who use them.
    • “The report, now in its 28th year, draws on tens of thousands of provider evaluations to identify the top-performing solutions in categories spanning electronic health records, revenue cycle, cybersecurity, AI and other areas. This year’s edition arrives as AI — particularly ambient speech technology — continues to reshape clinical workflows, and as health systems navigate tightening finances alongside growing vendor competition.
    • “For the 16th consecutive year, Epic was named the top Overall Health System Suite. Epic also won Best in KLAS recognition in 11 market segments.
    • [The article lists] the winners in some of the report’s most closely watched categories. The full report is accessible from KLAS Research here.
  • Per Beckers Payer Issues,
    • “Optum has launched a pair of AI-driven prior authorization products, one designed to speed up submissions on the provider side and another to accelerate clinical reviews for payers.
    • “The provider-facing product, Digital Auth Complete, went live in January in collaboration with digital health company Humata Health. The payer-facing product, InterQual Auth Accelerator, began piloting with two large health plans in late 2025, with the first payer expected to be fully live by April.
    • “It’s a combination of three things,” John Kontor, MD, senior vice president of clinical technology at Optum Insight, told Becker’s, explaining why the products are coming to market now. “It is the policy changes, including CMS-0057, that have accelerated everyone’s urgency to get this figured out. Two, it’s the readiness now of technology to be able to support solving many of these administrative, burdensome problems in healthcare. And third, the policy changes really reflect both industry frustration and impatience and the public’s real desire to get real and better answers to the problems of prior authorization.”
  • Per Fierce Healthcare,
    • “Epic is rapidly building out artificial intelligence tools integrated into its electronic health record solution as health IT companies strive to keep up with the dizzying speed of AI innovation.
    • “This week, the EHR giant released AI Charting, a built-in feature that ambiently listens during patient visits and drafts the clinician’s note. The AI charting feature also queues up orders based on the conversation. 
    • “Epic CEO Judy Faulkner announced the AI Charting technology during the company’s Users Group Meeting (UGM) in August as part of its collaboration with longtime partner Microsoft.
    • “AI models are advancing at a rapid pace; we continue to work with Microsoft on AI Charting and use a variety of different models through the Microsoft Azure platform,” an Epic spokesperson said Wednesday.”

Tuesday report

David Ermer–ACA, Congress, FDA, Medical / Rx research, Medicare, Obesity, SDOH, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Appropriations Committee Jan. 20 released text of a three-bill minibus for fiscal year 2026 that includes funding for key health programs and other bipartisan health care provisions and extensions. The bill provides a discretionary total of $116.6 billion to the Department of Health and Human Services and maintains funding for key rural health, health care workforce and behavioral health programs. The bill has several priorities supported by the AHA, including one-year extensions of the Medicare-dependent Hospital and low-volume adjustment programs, a two-year extension of telehealth flexibilities, as well as a one-year delay of payment reductions for clinical laboratory services. It also includes a five-year extension of hospital at home flexibilities and eliminates Medicaid Disproportionate Share Hospital cuts until FY 2028. Additionally, the bill includes a provision requiring separate unique health identifiers for off-campus hospital outpatient departments, which the AHA says is redundant as hospitals already disclose care locations, and it would impose unnecessary costs and administrative burden by forcing changes to existing billing systems. The House is expected to vote on the bill this week, with the Senate expected to follow next week before the Jan. 30 funding deadline.”
  • STAT News notes,
    • “Th[is] bill would prohibit PBMs from linking their payments to drug prices in Medicare and increase transparency in that program. The bill would ban PBMs from charging Medicaid more than they pay for drugs, a practice called spread pricing. And in the commercial market, the bill would require PBMs to pass through 100% of rebates to employer-sponsored insurance plans. There also is a measure requiring that PBMs give pharmacies who want to be part of their network reasonable contracts. 
    • “However, some of those measures could be taken out if the nonpartisan Congressional Budget Office determines that they would cost money, Smolinski said. The commercial market requirements and Medicaid spread pricing measures are examples of measures that the CBO could determine would increase government spending.”
  • Per Beckers Hospital Review,
    • [This bill] does not extend the enhanced ACA subsidies that expired at the end of 2025, a point of concern for hospitals as insurance premiums rise for millions of people across the country.
  • Govexec adds,
    • “Negotiators in both chambers of Congress have reached an agreement to fund every federal agency in fiscal 2026, with appropriators announcing a final deal on Tuesday, giving lawmakers 10 days to get the remaining bills to President Trump’s desk before a shutdown would occur.
    • “The Senate last week passed a second “minibus” package of spending bills, sending the measure to Trump to clear out half of the 12 annual must-pass appropriations bills. The House has already passed a third package—funding the departments of State and Treasury, and other governmentwide oversight agencies—and the Senate is expected to pass it next week. 
    • “Lawmakers on Tuesday unveiled the fourth and final minibus, which would fund the departments of Defense, Labor, Health and Human Services, Education, Homeland Security, Transportation and Housing and Urban Development. Those agencies, as well as State and Treasury, are currently funded through a stopgap continuing resolution that is set to expire after Jan. 30. 
    • “The new package marks yet another breakthrough between Republicans and Democrats in both the House and Senate.” * * *
    • “The House is expected to approve the measure this week. The Senate would then take it up next week, when it returns from recess. Lawmakers will have to pass the bill and Trump would then have to sign it into law by Jan. 30 to avoid the second shutdown of the fiscal year.” 
  • Per an HHS news release,
    • The HHS Office of Inspector General released its annual report about “2025 Top Management & Performance Challenges Facing HHS.”
  • Per a CMS news release,
    • “January 20, 2026 – Medicare Secondary Payer and Certain Civil Money Penalties Group Health Plan Webinar Now Available 
    • “The presentation from the January 13th Medicare Secondary Payer and Certain Civil Money Penalties Group Health Plan Webinar is now available in the Download section below.”
  • Beckers Payer Issues ranks the States by Affordable Care Act enrollment change since 2025.
    • “New Mexico has seen the biggest increase in ACA enrollment from 2025 to 2026, while North Carolina has seen the largest decrease, according to KFF.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “French vaccine developer Valneva said it is voluntarily pulling the paperwork underlying the approval of its chikungunya virus shot in the U.S., ending a short-lived marketing run marred by safety concerns. 
    • “In a Monday statement, Valneva said it recently learned that the Food and Drug Administraiton placed a clinical hold on the vaccine, Ixchiq, pending an investigation of a newly reported serious adverse event that occurred outside the U.S. The company has responded by withdrawing its FDA applications altogether.”
  • MedTech Dive tells us,
    • “Boston Scientific has told customers to stop using certain stents linked to three deaths, the Food and Drug Administration said Friday.
    • “The FDA published an early alert about issues with deployment and expansion of certain Axios Stent and Electrocautery Enhanced Delivery Systems.
    • “Boston Scientific wrote to customers about the issues, which the FDA said were linked to 167 serious injuries, late last year to prevent further use of the products.”
  • Radiology Business informs us,
    • “A group of PET scanners manufactured by GE HealthCare are the subject of a new recall from the U.S. Food and Drug Administration (FDA). 
    • “On January 16, the FDA updated its list of medical device recalls to include certain Omni Legend systems from GE. The recall was issued due to the potential for the systems to produce artifacts during PET exams, which could skew readers’ ability to assess images accurately.” * * *
    • “More information regarding the specific systems impacted by the recall can be found here.”  

From the judicial front,

  • The AHA News reports,
    • “The federal government has dropped its appeal of a preliminary injunction blocking implementation of the Department of Health and Human Services’ 340B Rebate Model Pilot Program.
    • “The move comes after the 1st U.S. Circuit Court of Appeals Jan. 7 denied the government’s motion for a stay in a lawsuit filed by the AHA, the Maine Hospital Association and four safety-net health systems challenging the program.
    • “The 1st Circuit ruling follows a Dec. 29 decision from the U.S. District Court of Maine granting a preliminary injunction blocking implementation of the program, which was scheduled to go into effect Jan. 1. The district court held that the Health Resources and Services Administration’s approval of the nine manufacturer applications that collectively comprise the entire program likely violated the Administrative Procedures Act.
    • “In a court filing, the government has signaled it will restart the administrative process related to the program; however, it has not released specific details.” 

From the public health and medical / Rx research front,

  • Pulmonology Advisor reports,
    • “Increased risk for non-small cell lung cancer (NSCLC) in never-smokers is significantly associated with underlying chronic lung disease, a family history of lung cancer, and unemployment, researchers reported in Chest.” * * *
    • “These findings underscore the multifactorial nature of LCINS and highlight the need for a comprehensive, multifactorial risk-assessment approach to better identify high-risk populations among never-smokers,” the researchers concluded.”
  • The American Journal of Managed Care tells us,
    • Colorectal cancer (CRC) incidence is increasing among young adults, with significant survival disparities linked to socio-economic status (SES) and race.
    • Black patients and those from lower SES neighborhoods had poorer 3-year survival rates, but only SES remained significant after adjustment.
    • The study highlights the impact of structural inequities on survival outcomes, emphasizing the need for multilevel interventions.
    • Limitations include small sample sizes for certain racial groups and potential aggregation issues, affecting generalizability.
  • Health Day informs us,
    • “Fingertip blood oxygen monitors return false readings for people with darker skin tones.
    • “The devices might miss low blood oxygen levels among dark-skinned patients.
    • “The darker the skin tone, the more inaccurate the devices become.” * * *
    • “In the linked editorial, Valley and colleagues agreed that for the time being, doctors will have to do their best, while understanding the devices’ flaws.
    • “The goal is not to abandon pulse oximetry but to understand its limits and make it equitable, ensuring that the technology designed to measure oxygen does not itself perpetuate inequalities in those who receive it,” the editorial said.”
  • STAT News points out,
    • “In a new secondary analysis of the larger trial published Monday in the Annals of Internal Medicine, [Mary Elizabeth] Patti [MD] and her colleagues asked how different social determinants of health affected outcomes after bariatric surgery compared to medical therapy for people with type 2 diabetes and obesity.
    • Bariatric surgery was better than medical therapy across all social backgrounds, they found, and not just in areas of higher deprivation. The ancillary study was smaller, and some of the participants randomized in earlier stages crossed over from medical to surgical treatment, and the reverse. The authors acknowledged and accounted for these limitations, along with the rapid development of more powerful obesity drugs not fully captured in the study. 
    • Still, “bariatric surgery remains an underutilized approach. Even in comparison to these really wonderful medications that we now have access to, it is still better,” Patti, director of the hypoglycemia clinic at Joslin Diabetes Center in Boston, told STAT. “I’m not a surgeon, but I think we need to keep in mind that surgery offers an approach which can be a durable therapy for type 2 diabetes and obesity.”
  • and
    • “Corvus Pharmaceuticals reported updated results Tuesday from an early-stage study of an oral treatment for eczema that has the potential to be more effective than currently approved drugs, including the blockbuster therapy Dupixent.
    • “After eight weeks, 75% of participants treated with the Corvus pill, called soquelitinib, achieved at least a 75% improvement in the extent and severity of skin lesions — an efficacy metric known as EASI 75 — compared to 20% of participants offered a placebo, the company said.
    • “The study also found that 33% of treated participants achieved clear or almost clear skin after eight weeks, as assessed by physicians, compared to none of the participants in the placebo group. 
    • “Side effects, all mild, were reported in 42% of participants treated with soquelitinib and did not result in any dose modifications or interruptions. No serious side effects were reported, Corvus said.”
  • The American Medical Association lets us know what doctors wish patients knew about hepatitis A, B and C.
    • “Chronic viral hepatitis affects millions of people worldwide. But the tricky part is that people infected with hepatitis viruses may not show symptoms, causing many to be unaware they have this condition. 
    • “While many patients with an acute infection fully recover after a few weeks, others develop chronic infection. That is why it is vital that patients know the ABCs of viral hepatitis and understand when to seek help.”
  • Genetic Engineering and Biotechnology News relates,
    • “An international team of scientists, headed by a team at Nanyang Technological University, Singapore (NTU Singapore), has discovered a new way that could speed up the healing of chronic wounds infected by antibiotic-resistant bacteria.
    • “Collaborating with researchers at the University of Geneva, the team’s preclinical study showed how a common bacterium, Enterococcus faecalis, actively prevents wound healing. The results of their collective studies in mice and in human cells showed that, unlike other bacteria, which produce toxins when they infect wounds, E. faecalis produces reactive oxygen species (ROS), which impairs the healing process of human skin cells.
    • “The team identified extracellular electron transport (EET) as a previously unrecognized mechanism by which E. faecalis generates ROS, which, in turn, activates the unfolded protein response (UPR) in epithelial cells and impedes their migration following wounding. The study also demonstrated how neutralizing this biological process can allow skin cells to recover and close wounds.
    • “Establishing a direct link between bacterial metabolism and host cell dysfunction, the study points to a potential new therapeutic strategy for chronic wounds. Co-senior and co-corresponding author, NTU associate professor Guillaume Thibault, PhD, at the School of Biological Sciences, and colleagues reported on their findings in Science Advances, in a paper titled “Enterococcus faecalis redox metabolism activates the unfolded protein response to impair wound healing,” in which they concluded, “Our findings establish EET as a virulence mechanism that links bacterial redox metabolism to host cell stress and impaired repair, offering new avenues for therapeutic intervention in chronic infections.”

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute posted its reports about “The Shifting Landscape of Employment-Based Health Benefits: Long-Term Resilience, Small-Employer Erosion, and the Threat of Higher Premiums,” and its “2025 Workplace Wellness Survey.”
    • “Employers’ commitment to worker health dates back to the late 1800s, but it was during World War II that employers began to offer more formal health coverage. Employers today offer health coverage because of their belief that offering it has a positive impact on the overall success of the business. It can be argued that the Employee Retirement Income Security Act of 1974’s (ERISA’s) preemption of state law has created an environment of nationally uniform standards for employee benefit plans, thus giving employers the regulatory means to continue to offer health benefits as they do today. Despite predictions spurred by the Patient Protection and Affordable Care Act of 2010 (ACA) that employers would stop offering coverage, employment-based health insurance remains resilient.”
    • “This edition of the Workplace Wellness Survey found that American workers’ average level of concern about their physical, mental, and workplace well-being was a 5.8 out of 10, up from 5.5 in 2024. Some other the key conclusions in the survey were that 56 percent of workers were very or extremely satisfied with their current job, with a few expressing dissatisfaction; top suggestions for improvement to benefits were a greater employer contribution and more flexibility of benefits to choose from; and half of the workers were open to using AI as a tool to help with benefits, but significant shares remained skeptical.”
  • Beckers Payer Issues informs us,
    • “Sustained GLP-1 use slows medical cost growth, according to findings published Jan. 13 from professional services firm Aon.
    • “The firm analyzed 192,000 GLP-1 users from July 2022 to March 2025, comparing outcomes to non-users, through commercial medical and pharmacy claims data. This research builds off 2025 analyses.
    • “These results provide employers a much clearer view of how GLP‑1 therapies can change the trajectory of both health risks and longer-term costs in their workforce,” Aon North America Health Solutions Leader Farheen Dam said in a news release. “The real impact comes when employers consider not just coverage, but also how these medications are used, supported and sustained over time. By pairing thoughtful GLP-1 strategies with programs that encourage adherence and total well-being, organizations can improve outcomes for their workforce.”
  • Fierce Pharma notes,
    • “Five weeks after telling investors to expect a revenue decline in 2026, Pfizer has found a quick funding fix, selling off its stake in GSK’s ViiV Healthcare.
    • “The New York powerhouse has agreed to surrender its 11.7% interest in the HIV-focused company for $1.875 billion. Under terms of the agreement, Shionogi will pick up Pfizer’s shares for $2.125 billion, with GSK gaining a special dividend of $250 million.
    • “The deal allows majority owner GSK to retain its 78.3% interest in ViiV, while Osaka, Japan-based Shionogi will boost its stake in ViiV from 10% to 21.7%. The companies expect to close the deal in the first quarter of this year.”
  • and
    • “With star checkpoint inhibitors like Keytruda and Opdivo now sporting subcutaneous formulations, GSK has struck a deal aimed at ensuring its own PD-1 stalwart doesn’t miss out on the action.
    • “GSK, through its oncology subsidiary Tesaro, is handing over $20 million upfront to Alteogen for global rights to the Korean biotech’s novel hyaluronidase enzyme ALT-B4. Tesaro plans to use the tech to develop and potentially market a subcutaneous form of Jemperli (dostarlimab).
    • “To sweeten the deal, GSK and Tesaro are offering up to $265 million more tied to certain development, regulatory and sales milestones, Alteogen said in a Jan. 20 press release. Alteogen will also be in line to earn royalties on sales of subcutaneous Jemperli, should it win approval and go to market.”
  • BioPharma Dive adds,
    • GSK on Tuesday said it’s agreed to buy Rapt Therapeutics for $2.2 billion, gaining access to a drug that promises to help a wider population of patients avoid allergic reactions to food.
    • The medicine, ozureprubart, targets the immunoglobulin E, or IgE antibodies that are produced when a patient’s immune system overreacts after encountering allergens. Once released, the IgE antibodies help trigger allergic reactions that can sometimes be deadly for patients. 
    • Ozureprubart is currently in Phase 2b testing, and Rapt believes it has the potential to be administered every eight to 12 weeks, instead of the two-to-four week regimens currently used for Roche and Novartis’ Xolair. The company also expects the drug to be used by a bigger pool of patients, including those with high levels of IgE or a body weight that makes them ineligible to take Xolair.
  • Per Radiology Business,
    • “[Last] week iSono Health—a company that specializes in developing solutions catered to women’s health—announced the commercial launch of its wearable breast ultrasound system.  
    • “ATUSA is an artificial intelligence-enabled ultrasound device that delivers 3D automated imaging of the breast at the point of care. ISono Health developed the system to address the diagnostic gap between women with dense breast tissue and challenges accessing supplemental imaging. The company believes the product has the potential to address shortages of skills sonographers by putting the easy-to-use technology directly in the hands of providers in clinic. 
    • “ATUSA is a systemwide upgrade for women’s breast health,” Neda Razavi, CEO of iSono Health, said in an announcement. “We are putting the power of a world-class radiology suite into the hands of local clinicians, replacing slow, manual workflows with real-time diagnostic images at the point of care.” 

Thursday Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health, medical / Rx research front,

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

From the U.S. healthcare business front,

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

Happy New Year 2026

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

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

From Washington, DC,

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

From the judicial front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

From the public health and medical / Rx research front,

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

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

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

Thursday report

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

From Washington, DC,

  • The Society for Human Resource Management tells us,
    • “In an address to the nation on Dec. 17, President Donald Trump spoke about the economy, efforts to lower prescription drug prices, and his plans for the year ahead. He noted the pending launch of a new website, TrumpRx.gov, in January 2026, highlighted economic progress, and announced a bonus payment of $1,776 to every military service member as a “Warrior Dividend.” He also touted his economic record and predicted the country is “poised for an economic boom the likes of which we’ve never seen.”
  • STAT News adds,
    • When HCA Healthcare, one of the largest hospital systems in the U.S., recently told employees it would stop covering blockbuster obesity drugs Zepbound and Wegovy next year, it pointed them to an alternative way to get the treatments: Buy them themselves.
    • In a notice viewed by STAT, HCA said use of the GLP-1 weight loss drugs surged 90% this year, “significantly” raising costs. It instead suggested employees enroll in discount programs introduced by the drugs’ manufacturers, Eli Lilly and Novo Nordisk, which allow patients to buy the medicines without using insurance at cash prices that are lower than the list prices.
  • The Wall Street Journal reports,
    • “Millions of Americans are facing higher healthcare premiums and lingering uncertainty about whether help might still arrive, with Congress set to break for the rest of the year without renewing enhanced Affordable Care Act subsidies. 
    • “Supporters of the subsidies insist the fight isn’t over. But prospects of a bipartisan deal remain slim, even as some lawmakers and people close to the Trump administration signaled that voter pressure could lead to a retroactive fix when Congress reconvenes in the new year.
    • “I’m not ruling anything out,” Senate Majority Leader John Thune (R., S.D.) told reporters Thursday.”  
  • Modern Healthcare adds,
    • “Health insurance exchange shoppers facing huge premium hikes are scrambling for deals during this sign-up season.
    • “Insurance brokers report high interest in bottom-tier, lower-cost Bronze plans, policies only available outside the exchanges and alternatives such as short-term plans. Some of those consumers are downgrading from Silver or higher amid skyrocketing prices tied to the expiration of enhanced subsidies at the end of the year.
    • “Yet enrollment in Affordable Care Act of 2010 plans was outpacing last year as of Dec. 5, when sign-ups reached 5.8 million, a 7% increase from the same period in 2024, the Centers for Medicare and Medicaid Services reported. Notably, 950,000 enrollees were new to the exchanges. Open enrollment began Nov. 1 and runs until Jan. 15 in most states, although Monday was the last day to choose a plan that would be in place on Jan. 1.
    • ​“All of the attention that has been paid to the market has actually helped enrollment,” said Wesley Sanders, founder and principal consultant at the health insurance consulting firm Evensun Health.” 
  • Govexec informs us,
    • “President Trump on Thursday issued an executive order implementing his plan to provide civilian federal workers with a 1% across-the-board pay raise next month.
    • “As first proposed in August, the increase is entirely being applied to buttress federal workers’ basic pay, with no changes to locality pay rates coming next year. Though the White House skipped outlining its pay raise plans as part of its annual budget proposal, officials initially planned on issuing a pay freeze for 2026. * * *
    • “The administration published pay tables outlining the 2025 pay raise across the General Schedule, along with tables for VA health workers, senior executives, and military service members on the White House website.”
    • [The executive order further states “Additionally, the Director of the Office of Personnel Management (Director) is directed to assess whether to provide up to a total increase of 3.8 percent (inclusive of the increase provided under Section 1) to the rates of pay of certain Federal civilian law enforcement personnel, as determined by the Director following coordination with agencies and consistent with 5 U.S.C. 5305.”}
  • and
    • “President Donald Trump in an executive order on Thursday gave the federal workforce a holiday on Dec. 24 and 26. Because Christmas falls on a Thursday this year, this provides government workers with a five-day weekend. 
    • “According to the directive, agency heads can require certain offices to remain open on either day due to national security, defense or other public need.” 
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services announced Dec. 18 that it will launch a voluntary payment model designed to broadly reach more health care providers who have not joined accountable care organizations, including those with specialized patient populations and others such as small, independent or rural-based practices. The Long-term Enhanced ACO Design Model will begin Jan. 1, 2027, and continue for 10 years. CMS said ACOs can apply for participation in March following the release of a request for applications.”
  • and
    • “The Department of Health and Human Services Dec. 18 announced three regulatory actions related to the practice of “sex-rejecting procedures” on children.
    • “The Centers for Medicare & Medicaid Services issued a proposed rule that would prohibit hospitals participating in the Medicare and Medicaid programs from performing SRPs on individuals under 18 years of age. The proposed condition of participation defines SRPs as “any pharmaceutical or surgical intervention that attempts to align an individual’s physical appearance or body with an asserted identity that differs from the individual’s sex …” and would include procedures that would intentionally disrupt, suppress or alter the development of an individual’s biological functions, physical appearance or body. The proposed rule provides exceptions for the treatment of an individual with a verifiable disorder of sexual development, for uses other than attempting to align an individual’s physical appearance or body with an identity other than the individual’s sex, or to treat complications arising from, or exacerbated by, previous performance of an SRP. The proposed rule did not specify how the proposed prohibitions would be enforced.
    • “Separately, CMS published a proposed rule that would prohibit states from receiving federal matching funds for SRPs provided to Medicaid and separate Children’s Health Insurance Program beneficiaries under the age of 19. CMS notes that these proposed changes would not prevent states from providing coverage for SRPs with state-only funds. The exceptions outlined in the COP proposed rule are also applied to the Medicaid/CHIP rule.
    • “Comments on the proposed rules are due Feb. 16.
    • “HHS’ Office for Civil Rights also proposed to revise its regulations implementing Section 504 of the Rehabilitation Act of 1973 to clarify that the definitions of “disability” and “individual with a disability” exclude “gender dysphoria” not resulting from physical impairments. Comments on HHS OCR’s rule are due Jan. 20.”
  • Per Healthcare Dive,
    • “The Federation of American Hospitals has tapped Charlene MacDonald as its next CEO, the for-profit hospital association said Tuesday.
    • “MacDonald is succeeding Chip Kahn, who announced his retirement earlier this year. Kahn is stepping down after almost 25 years at the helm of the FAH.
    • “MacDonald previously led the FAH’s lobbying, public affairs and communications efforts, and oversaw its finance and operations teams. She’ll start as CEO on Jan. 1.”

From the Food and Drug Administration front,

  • BioPharma Dive lets us know,
    • “Eli Lilly’s experimental obesity pill orforglipron helped people maintain their weight following a 72-week course of the GLP-1 shots Zepbound or Wegovy in a Phase 3 clinical trial, opening up a potential new use for drugs of its kind.
    • “People taking orforglipron after Wegovy gained less than one kilogram over the span of a year, while those who got Zepbound regained five kilograms. Both ended up at the same average at the end of the study period, however, and placebo recipients regained more than nine kilograms before being offered “rescue” orforglipron.
    • ‘Lilly also said it has officially asked the Food and Drug Administration to approve orforglipron. The pill was awarded one of the FDA’s new “national priority” vouchers, making a decision likely within weeks rather than the standard six to 10 months.”
  • Fierce Pharma reports,
    • “A year after an FDA rejection, Johnson & Johnson has won approval for a more convenient version of its lung cancer drug Rybrevant to better challenge AstraZeneca’s Tagrisso.
    • “Rybrevant Faspro, a subcutaneous formulation of Rybrevant, is now cleared in the same indications as the original intravenous infusion, including its use alongside J&J’s Lazcluze for the first-line treatment of EGFR-mutated metastatic non-small cell lung cancer (NSCLC).
    • “Compared with the original Rybrevant, the under-the-skin version reduces the antibody drug’s administration time from several hours to about five minutes, which J&J suggests is more convenient for patients and less burdensome for healthcare resources.
    • “This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment,” Joelle Fathi, chief healthcare delivery officer at GO2 for Lung Cancer, a patient support group, said in a Dec. 17 statement.”
  • MedTech Dive points out,
    • “Pulse Biosciences said Thursday it got the Food and Drug Administration’s go-ahead to begin an investigational device exemption study of its cardiac catheter ablation system to treat drug-resistant paroxysmal, or intermittent, atrial fibrillation.
    • “The company has developed technology that delivers nanosecond electrical pulses to treat the heart rhythm condition. Nanosecond pulses are briefer in duration than the microsecond pulses used in other pulsed field ablation systems, which could offer advantages. The Pulse Biosciences catheter is designed to deliver a complete lesion in a single energy application.
    • “Pulse Biosciences will evaluate the safety and effectiveness of its nPulse ablation catheter in the single-arm, multicenter NANOPULSE-AF study.:
  • and
    • “CMR Surgical said Tuesday it received 510(k) clearance from the Food and Drug Administration for its next-generation robotic system to perform gallbladder removal procedures.
    • “The Cambridge, England-based company said more than 40,000 surgical procedures have been completed with its robotic platforms outside of the U.S., across multiple specialties and care settings.
    • “CMR said it is on track to begin launching the new system, called Versius Plus, in the U.S. in 2026.”

From the judicial front,

  • ABC News reports,
    • “The evidence suppression hearing in the case against accused CEO killer Luigi Mangione concluded Thursday after the defense signaled it would call no witnesses.
    • “The defense rests,” defense attorney Karen Agnifilo said after prosecutors indicated they, too, rested.
    • “The nine-day hearing will determine what evidence will be used against Mangione when he goes on trial on charges of gunning down UnitedHealthcare CEO Brian Thompson on a Manhattan sidewalk last year.
    • “New York Judge Gregory Carro gave the defense until Jan. 29 to make its final argument about the evidence in writing.  Prosecutors have until March 5.  The defense then has two weeks after that to submit a reply.
    • “Carro said he expected to issue his decision about what, if any, evidence to exclude on May 18, at which point he would also set a date for trial.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The Los Angeles wildfires of nearly a year ago took an unexpectedly heavy toll on residents’ health, a new study found. 
    • “An unusually large number of people suffered from heart attacks, lung conditions and a perplexing rise in unexplained illnesses, according to an analysis by researchers of emergency-department data at Cedars-Sinai, the largest hospital in Los Angeles County. 
    • “Their findings offer clues into the potential cost to human health of massive wildfires that spread quickly from wild lands into urban areas, said Dr. Susan Cheng, vice chair for research affairs at Cedars-Sinai’s Smidt Heart Institute and senior author of the study.
    • “Such wildfires are increasing in frequency and scope, and release heavy metals and other toxins into the air as they engulf homes and cars. 
    • “You have a much greater magnitude and a much greater complexity of toxins being produced by the disaster affecting a very large, large population of people,” she said.” 
  • NBC News relates,
    • “As of Dec. 6, the Centers for Disease Control and Prevention had logged 26,632 cases of whooping cough in 2025. The last time the U.S. saw so many cases was more than a decade ago, in 2014, according to CDC data.
    • “But an NBC News/Stanford University investigation has found that DTaP vaccination rates are plummeting across the country, as part of a larger, troubling trend of growing vaccine hesitancy that is fueling a resurgence of preventable diseases, including measles.”
  • Managed Healthcare Executive adds,
    • “While most (82%) primary care physicians (PCPs) in the United States understand the risk factors for shingles, far fewer (29%) are fully aware of current shingles vaccine recommendations, according to a recent study published in Human Vaccines and Immunotherapeutics. The study was sponsored by GSK, the manufacturer of the recombinant zoster vaccine (RZV).”
  • BioPharma Dive notes,
    • “An experimental drug Takeda acquired in a multibillion-dollar deal has succeeded in a pair of late-stage trials, positioning the company to seek clearance of a therapy it expects to become a future blockbuster.
    • “The therapy, known as zasocitinib, met its co-primary and top secondary objectives in two Phase 3 studies testing it against a placebo or Amgen’s Otezla in patients with plaque psoriasis. Without disclosing specifics, Takeda said Thursday that, after four months, zasocitinib demonstrated “superiority” on both top study goals, which involved meaningfully reducing disease severity on two different measures. Respiratory tract infections, colds and acne were the most common side effects, according to the company.
    • “Takeda will provide detailed results at an upcoming medical meeting and intends to file for approvals in the U.S. and elsewhere during its 2026 fiscal year. Zasocitinib is also being evaluated in multiple other indications, as well as in a head-to-head study testing it against Bristol Myers Squibb’s similar, rival drug Sotyktu.”
  • and
    • “A streak of positive news that pushed Insmed into the ranks of the most valuable biotechnology companies ended this week with the announcement of a failed clinical trial.
    • “The company’s share price dropped almost 17% to about $165 early Thursday, following the announcement late Wednesday. The stock, which was worth around $25 a year and a half ago, had vaulted above $200 in trading this week.
    • “The Phase 2b study focused on a drug called brensocatib, which Insmed already sells under the brand name Brinsupri to treat a lung disease known as non-cystic fibrosis bronchiectasis. The company had hoped to expand use of the medicine to include a chronic nasal condition, but researchers found no benefit for either of the two doses they tested.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “All community pharmacies in Optum Rx’s network have transitioned over to a cost-based reimbursement model as the massive pharmacy benefit manager tries to reduce variation in how pharmacies are paid.
    • “Optum Rx first launched the model across roughly 1,400 community pharmacies in March. Now, the PBM, which is owned by healthcare conglomerate UnitedHealth, has notched agreements with three additional pharmacy services administration organizations representing more than 17,000 community pharmacies to transition them to cost-based contracts, Optum Rx said Thursday.
    • “Optum Rx aims to move all of its pharmacy partners to the new model, which should result in pharmacies being paid more for brand-name drugs and less for generics, by January 2028. The PBM is still working on those owned by retail chains and grocers, a network contracting executive said.”
  • Beckers Payer Issues tells us,
    • “UnitedHealthcare is delaying a coverage policy that would have sharply restricted remote physiologic monitoring services for most chronic conditions.
    • “The policy, which had been scheduled to take effect Jan. 1, will now be implemented later next year, the insurer confirmed to Becker’s.
    • “After listening to feedback from care providers, medical societies and other stakeholders, we are postponing the Remote Physiologic Monitoring (RPM) policy scheduled to take effect on Jan. 1, 2026. We still intend to implement this policy in 2026 and will share an updated timeline once it is finalized,” a UnitedHealthcare spokesperson said.”
  • BioPharma Dive notes,
    • “Moderna said Thursday its experimental bird flu vaccine, which was cut from federal funding earlier this year, will receive up to $54.3 million from a global coalition to advance the candidate.
    • “The Coalition for Epidemic Preparedness Innovations, or CEPI, a public-private global partnership working to develop vaccines against pandemics, agreed to fund Moderna’s candidate mRNA-1018 against H5 avian influenza into Phase 3 testing. As part of the agreement, if the shot is approved and in the event of an influenza pandemic, Moderna will allocate 20% of its production capacity for low- and middle-income countries, “at affordable pricing.”
    • “Under the Biden administration, the experimental vaccine was awarded over $700 million in government contracts from the Biomedical Advanced Research and Development Authority, or BARDA. Those contracts were later canceled by the Department of Health and Human Services under Secretary Robert F. Kennedy Jr., a major critic of messenger RNA technology.”
  • MedTech Dive relates,
    • “Editor’s note: This is the fourth article in a series of stories profiling medtech companies that are changing the field of robotic surgery. You can read the first three stories here, here and here.
    • “XCath is developing a robot-assisted approach to brain aneurysm treatment that could bring greater precision to procedures and enable more physicians to perform them.
    • “A cerebral aneurysm is a bulge in a weakened area of an artery in the brain. To prevent a life-threatening rupture of the vessel wall, endovascular interventions that access the aneurysm from inside the artery are increasingly preferred over traditional open surgery.
    • “While less invasive than open surgical repair, the intricate procedures are not free from complications and require significant technical skills to perform. A global shortage of neurointerventionists with expertise to perform the procedures has raised concerns about limited patient accessto critical stroke care.
    • “XCath, a Houston-based startup, is working on a robotic system that it expects to standardize endovascular brain aneurysm treatment. The goal is to facilitate consistent performance among a wider field of physicians, minimize complications and improve clinical outcomes.”

Midweek update

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Senate approved a sweeping defense-policy package despite alarm over a provision that rolls back safety measures put in place following the fatal midair collision in January between a military helicopter and passenger plane at Ronald Reagan Washington National Airport. 
    • “The Senate passed the $901 billion National Defense Authorization Act on a vote of 77-20, codifying more than a dozen of President Trump’s executive orders, while placing new limits on his ability to act unilaterally overseas. The House passed the annual measure last week 312 to 112, and it now goes to Trump’s desk for his signature.
    • “While the bill sets specific spending levels for the Pentagon, it doesn’t appropriate any money, which is done through separate legislation. Lawmakers added $8 billion to the Pentagon’s budget request. The legislation would increase America’s total national-security budget by less than 1% from last year’s $895 billion authorization bill. It also raises troop pay 3.8%.”
  • Fierce Healthcare adds,
    • “Nearly two years after its introduction as a bill during the last U.S. Congress, the Biosecure Act has survived an election and a presidential transition and appears poised to become law. But this version, tucked into the nation’s annual defense bill, features some changes from the first iteration.
    • “Both the House of Representatives and the Senate have passed the $901 billion defense bill, sending it to the president’s desk for a signature. The White House has said President Donald Trump plans to sign the massive defense package, Reuters reports.
    • “Within the mammoth bill, the Biosecure Act has the potential to raise new hurdles for certain life sciences companies from China, as well as their partners, although the exact effects of the legislation remain tough to fully assess at this stage.”
  • STAT News tells us,
    • “House Republicans on Wednesday passed a health care bill aimed at lowering health care costs and providing more options for employer-provided health insurance.” * * *
    • “The Lower Health Care Premiums for All Americans Act would expand access to association health plans by allowing small employers and self-employed individuals to band together across industries to buy insurance that is less regulated. Large employers already can offer this kind of coverage. About 700,000 more people per year on average would choose association health plans under the bill, about 200,000 of whom currently don’t have insurance, according to the nonpartisan Congressional Budget Office.” * * *
    • “Another measure would prevent states from regulating stop-loss insurance that self-insured plans use to protect against large claims to control costs. 
    • “It also would fund cost-sharing reductions for low-income enrollees in the Affordable Care Act marketplace. Funding cost-sharing reductions would lower gross premiums for benchmark silver plans by 11% on average, according to the CBO. Because ACA subsidies are based on the cost of a silver plan, that lowers the amount of tax credits available to buy any plan.” 
  • The Wall Street Journal further reports,
    • “Four vulnerable House Republicans rebelled against Speaker Mike Johnson (R., La.) and backed a Democratic effort to force a vote on extending Affordable Care Act subsidies, exposing GOP fractures over surging healthcare costs headed into next year’s midterm elections.” * * *
    • “With the GOP signatures on the discharge petition, Jeffries now has the 218 needed to force a vote, which wouldn’t likely occur until after the holiday break. But the centrists’ move could keep up pressure on both parties to reach a deal, and talks were continuing in the Senate on a possible compromise for early in the new year.
    • “The defections delivered a blow to Johnson’s leadership in the House, where he has been forced to manage a historically narrow majority—currently 220-213—that gives any small bloc of Republicans power to derail or hijack his agenda.
    • “We’re keeping a productive conversation going,” Johnson told reporters after the defectors signed onto the Democratic plan. “I have not lost control of the House.”
  • STAT News tells us,
    • “Several drugmakers are expected to sign pricing agreements with the Trump administration on Friday, according to four people familiar with the plans, who were not authorized to speak publicly.
    • “The agreements would be the latest in a series of deals in which pharmaceutical companies agree to lower drug prices and invest more domestically in exchange for avoiding tariffs and other benefits, such as fast-tracked drug reviews.”
  • An OPM Inspector General data brief lets us know that following an OPM mandate in January 2023, spending on GLP-1 drugs in the FEHB Program for the treatment of obesity surged dramatically. While OPM has the authority to make unilateral amendments to their FEHB and PSHB contracts with carriers, the carriers have a right to an equitable price adjustment. See Section 5.38 of the standard OPM contracts. The only way to achieve is an equitable price adjustment (or any price adjustment for that matter) is through the annual benefit and rate proposal process. OPM should have proposed the change for 2024, and then allowd the carriers to include the cost of these drugs in their 2024 premium. OPM didn’t do this. and this mistake caused FEHB premiums to jump more than they should have in 2025. This should be the lesson taken from this data brief.
  • Govexec informs us,
    • “The U.S. Postal Service on Wednesday announced plans to expand access to its last-mile delivery network, which the new postmaster general hopes will provide a boon to the financially struggling agency. 
    • “In the logistics business, the most expensive part of delivery is generally the ‘last mile’ portion of a route. As part of our universal service obligation, we deliver to more than 170 million addresses at least six days a week, so we are the natural leader in last-mile delivery,” Steiner said in a statement. “We want to make this valuable service available to a wide range of customers that see the worth of last mile access — other logistics companies and retailers large and small.” 
    • “USPS in late January or early February 2026 will begin auctioning off access to more than 18,000 delivery destinations, according to a press release. 
    • “Steiner said in an interview with Reuters about the program that it could raise billions in revenue for USPS, which is needed as the PG also warned that the agency could run out of money in early 2027.”
  • Federal News Network interviews NARFE’s Staff Vice President for Policy and Programs John Hatton.
    • Federal employees are seeing signs of stability. Retirement processing is improving, workforce protections are holding, and pay raise prospects are clearer. But with continuing resolutions and hiring freezes still in the mix, the path forward requires careful planning. What can be expected in the coming year?
  • Mercer informs us,
    • “Starting next July, employers can voluntarily contribute to the Trump accounts of employees’ dependent children. Created by the One Big Beautiful Bill Act (Pub. L. No. 119-21), these accounts are a new kind of tax-preferred savings vehicle for individuals under 18. Employer contributions up to $2,500 per year are excludable from an employee’s gross income if made pursuant to a program that meets certain conditions. This tax exclusion also applies to employer contributions to accounts of employees who are under 18. Originally published on Aug. 5, 2025, this article has been updated to reflect IRS guidance in Notice 2025-68. IRS intends to propose regulations consistent with the guidance in the notice. IRS is accepting comments on the notice through Feb. 20, 2026.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With a fresh endorsement from the FDA, the last of five major drug approvals has fallen into place for GSK in 2025.
    • “Tuesday, the U.S. regulator greenlit GSK’s depemokimab, an ultra-long-acting biologic, as a new add-on maintenance therapy for severe asthma with an eosinophilic phenotype in patients ages 12 and older. The drug will hit the market under the Exdensur brand name, GSK said in a Dec. 16 press release.
    • “GSK has drafted lofty sales ambitions for Exdensur, an IL-5 antagonist that is injected just twice a year. The British pharma has previously estimated the inflammatory disease med could reel in sales of 3 billion pounds sterling ($4 billion) at peak.”
  • BioPharma Dive informs us,
    • “DBV Technologies shares soared Wednesday after the company said its Viaskin peanut allergy patch succeeded in a Phase 3 trial.
    • “The results represent a comeback for the patch, which was rejected by the Food and Drug Administration in August 2020. At the time, regulators said the patch needed modifications to fully adhere to the skin and called for more data to support its efficacy.
    • “With the results of the trial, dubbed Vitesse, in hand, DBV now plans to submit an application to the FDA in the first half of next year to clear the patch for children between the ages of 4 and 7. The FDA has previously awarded the treatment a breakthrough therapy designation, and it may qualify for a priority review, DBV said Tuesday.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) said the United States has tracked 1,958 measles cases so far this year, nearing the 2,000-case milestone just one month before the country will likely lose its elimination status. 
    • “The total represents 46 new US cases.
    • “There have been 49 US outbreaks reported in 44 US jurisdictions, the CDC said, as well as 24 measles cases reported among international visitors to the United States. Eighty-eight percent of all measles cases reported this year have been outbreak-associated. 
    • “Among US cases, 26% are in children under the age of 5 years, 41% of patients are between 5 and 19 years, 32% are 20 years or older, and 1% have unknown ages. Ninety-three percent of case-patients are unvaccinated or have unknown vaccination status, while 3% have one dose of measles-containing vaccine, and 4% are fully vaccinated. 
    • “So far, 222 people (11%) have been hospitalized for measles infections in the United States this year, and three have died.”
  • and
    • “Two studies on respiratory syncytial virus (RSV) protection conclude that vaccine effectiveness against infection and related health care use drops over 18 months in US veterans and that the effectiveness of the long-acting monoclonal antibody preventive nirsevimab is strong in hospitalized European children younger than two years but wanes over seven months.
    • “Older adults and infants are especially vulnerable to severe RSV, with possible complications of bronchiolitis, pneumonia, and sepsis.” * * *
    • “In an editorial in the same journal, Editorial Fellow Anna Hung, PhD, of Duke University, and Associate Editor Lona Mody, MD, of the University of Michigan, noted that, despite the Centers for Disease Control and Prevention’s recommendation for a single dose for anyone aged 75 and older and those aged 60 to 74 years at increased risk for severe disease, less than half of either group receives the vaccine.
    • “This low uptake can be explained by various reasons including relative recency of development of the vaccine, lack of awareness of the seriousness and frequency of RSV infection, a hazy shared clinical decision-making model, access barriers, a general vaccine fatigue, and lack of clear guidance to clinicians,” they wrote. 
    • “They added that the greater decline in VE among immunocompromised veterans suggests the need for RSV boosters. “Experts will need to evaluate this evidence carefully to update guidance,” they wrote.”
  • The American Hospital Association News lets us know, “Depression and anxiety can increase the risk of a major adverse cardiac event, according to an American Heart Association study published Dec. 17.”
  • Health Day relates,
    • “Adherence to cervical cancer screening guidelines is low, with more than 60 percent undergoing overscreening, according to a research letter published online Dec. 10 in JAMA Network Open.
    • “Michelle B. Shin, Ph.D., M.P.H., R.N., from the University of Washington in Seattle, and colleagues examined cervical cancer screening guideline adherence among a nationally representative commercially insured cohort to assess factors and modalities associated with nonadherence. Data were analyzed from the 2013 to 2021 Optum Clinformatics anonymized longitudinal claims database covering about 13 million individuals annually.
    • “The researchers found that among 670,003 eligible individuals, 47.1 and 52.9 percent received cytology alone and cotesting, respectively. Overall, only 7.3 percent were guideline-adherent, while 61.6 and 31.1 percent were overscreened and underscreened, respectively.”
    • * * * “Consistent with prior work, we observed low adherence (7.3 percent) to cervical cancer screening guidelines among the commercially insured U.S. population despite stable coverage, likely reflecting guideline confusion among patients, clinicians, and health systems,” the authors write.”
       
  • Per the University of Minnesota’s CIDRAP,
    • “Treatment with the antiviral combination nirmatrelvir–ritonavir (Paxlovid) was associated with fewer lost workdays and lower disability-related costs among US employees at high risk for severe COVID-19, according to a retrospective observational study in the Journal of Medical Economics.
    • “Using insurance claims and workplace productivity data from large US employers, the researchers, led by scientists from Paxlovid maker Pfizer, compared productivity outcomes among high-risk employees diagnosed as having COVID who either received Paxlovid within five days of diagnosis or received no antiviral. 
    • “Analyses of absences among treated and untreated workers and those on short-term disability (STD) and long-term disability (LTD) included 1,909, 20,065, and 20,318 employees, respectively. The study included data from December 2021 through December 2022, a period dominated by Omicron variants.”
  • Per Fierce Pharma,
    • “The combination of Keytruda and Padcev is taking another major step toward securing its position as a leading therapy in the treatment of bladder cancer.
    • “The PD-1/antibody-drug conjugate pairing significantly extended the lives of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy compared with chemotherapy, according to results from the phase 3 Keynote-B15 (EV-304) trial. The study evaluated Keytruda and Padcev, given both before and after surgery in what’s known as a perioperative treatment, and compared the regimen with neoadjuvant chemotherapy followed by surgery.
    • “Keytruda developer Merck & Co. sponsored the study in collaboration with Padcev makers Astellas and Pfizer. The three firms announced the positive top-line readout from an interim analysis Wednesday.”
  • and
    • “Armed with new three-year data demonstrating the benefits of Anktiva in a specific patient subset, ImmunityBio is proving its bladder cancer med is still one to watch as it competes with heavy hitters from Merck and Johnson & Johnson.
    • “Last year, the company won a long-sought FDA approval for its drug—used alongside the Bacillus Calmette-Guérin (BCG) vaccine—to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. 
    • “That nod set up a showdown with Merck’s Keytruda and Ferring Pharmaceuticals’ gene therapy Adstiladrin. More recently, the competition has amped up, with Johnson & Johnson’s Inlexzo hitting the scene and putting pressure on IL-15 receptor agonist Anktiva.
    • “Not deterred by the expanding competitive landscape, ImmunityBio is using new data from the company’s Quilt-3.032 study to flesh out Anktiva’s benefits in patients with BCG-unresponsive high-grade papillary-only NMIBC. Papillary tumors and CIS are the two clonally linked subtypes of NMIBC, ImmunityBio explained in a Dec. 16 press release. 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Oscar Health, Angle Health, Curative, Centivo and Sidecar Health are testing the market for alternative health plans.
    • “Options such as variable copay plans and individual coverage health reimbursement arrangements may appeal to employers seeking to cut costs.
    • “Leading insurers such as UnitedHealthcare, Aetna, Cigna, and Blue Cross and Blue Shield companies are active in this market.
    • “More than one-third of large businesses will offer nontraditional health benefits in 2026, according to Mercer.”
  • Fierce Healthcare relates,
    • “Cigna’s Evernorth launched a behavioral-health-focused medical group in 2024 to meet the demand for behavioral health therapy and support.
    • “In the past 18 months, Evernorth has expanded its Behavioral Care Group from virtual services in six markets and a network of 1,000 providers to more than 5,000 providers across all 50 states.
    • “Evernorth now plans to grow the medical group to more than 15,000 providers next year.
    • “The medical group also now offers in-person appointments to complement its virtual care services. Evernorth executives say this hybrid approach allows patients to choose the care setting that best suits their needs without compromising on quality or convenience.”
  • BioPharma Dive points out,
    • “Biotechnology startup Orum Therapeutics has banked 146 billion Korean won, or about $100 million, to fuel development of medicines that merge elements of two popular drugmaking approaches.
    • “Orum on Thursday said that proceeds from the round — which was led by KB Investments and involved seven other firms — will help advance a potential acute myeloid leukemia drug called ORM-1153 and that recently became its top candidate.
    • “The startup, which has offices in Cambridge, Massachusetts, and Daejeon, South Korea, is developing what are known as “degrader-antibody conjugates.” These drugs are a twist on the antibody-drug conjugates, or ADCs, used to treat multiple cancers. ADCs link a targeting molecule to a tumor-killing toxin. Orum’s drugs, by comparison, use a protein-degrading compound as a payload.”
  • Per Axios,
    • “Employer-sponsored insurance may be getting costlier, but it still delivers a positive return for firms that cover their workers, according to a new Avalere Health analysis commissioned by the U.S. Chamber of Commerce and provided first to Axios.
    • “Why it matters: Workplace insurance is the backbone of the American health care system, covering around half of the population. Whether it’s a well-functioning system or not, workers and families depend on it.
    • “What they found: The analysis measured what companies get back from each dollar invested in health benefits and concluded benefits exceeded costs for firms of all sizes this year, and that ROI will only grow through 2029.
    • “Employer insurance will yield an estimated 120% ROI to employers in the aggregate in 2025 and a 137% return in 2029, per the analysis.
    • “That comes from increased productivity, tax benefits and increased retention.”

Tuesday report

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

From Washington, DC,

  • Politico reports,
    • “A bipartisan group of nearly two dozen senators huddled Monday night to work out an 11th-hour health care deal to extend Affordable Care Act insurance subsidies set to expire at the end of this month.
    • “At a meeting convened by Sens. Susan Collins (R-Maine) and Bernie Moreno(R-Ohio), the senators discussed a two-year extension of the Obamacare tax credits that would be coupled with a new income eligibility cap and fraud prevention language.
  • The Wall Street Journal adds,
    • “Senate Majority Leader John Thune (R., S.D.) said Congress won’t be able to extend federal health-insurance subsidies before leaving for the holidays, ending hopes for a last-minute deal and punting any possible fix into the new year.
    • “We’re not going to pass anything by the end of this week, but I do think there’s a potential pathway in January,” Thune said at a press conference on Tuesday. Lawmakers are expected to depart Washington before the weekend and won’t return until Jan. 5.” * * *
    • “House Republicans still are expected to pass a GOP healthcare bill on Wednesday that would expand access to association health plans, which generally allow small employers to band together and provide health insurance, and appropriate money to fund the cost-sharing reductions that reduce out-of-pocket spending for lower-income ACA enrollees. It doesn’t include any ACA extensions or the health savings accounts favored by many Republicans. 
    • “The Congressional Budget Office said the bill would reduce the federal deficit by $35.6 billion over a decade, but it would also reduce the number of people with health insurance by an average of 100,000 a year.” 
  • OPM Director Scott Kupor added a post about the new U.S. Tech Force to his Secrets of OPM blog today.
  • Federal News Network adds,
    • “Agencies will soon see a more streamlined process for potentially offering higher-value bonuses to federal employees who are being hired or relocated.
    • “A new final rule from the Office of Personnel Management on Tuesday seeks to reduce “administrative burden” and “increase efficiency” in the process for approving recruitment and relocation incentives. The changes come after OPM first proposed regulations in November 2023.
    • “In practice, OPM’s changes will shift the transactional work of approving waivers for larger bonuses off of OPM’s plate, and instead make it the responsibility of individual agencies. The goal is make the process for offering pay incentives easier, and in theory free up time for OPM to focus on other priorities, according to the final rule.”
  • HHS Assistant Secretary for Technology Steve Posnak remarks in his agency’s HealthBuzz blog
    • In July the Centers for Medicare & Medicaid Services (CMS) launched an ambitious Health Technology Ecosystem pledge program. The groundswell of energy and enthusiasm for the program has been remarkable, and we’re glad to be their partner. CMS established several pledge categories associated with aspirational criteria included within its CMS Interoperability Framework. This [HealthBuzz] post looks specifically at the similarities and differences between the Trusted Exchange Framework and Common Agreement™ (TEFCA™) and the “CMS-Aligned Network” pledge category.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Harvey Risch, M.D., Ph.D., as chairman of the President’s Cancer Panel. The panel, part of the National Institutes of Health’s (NIH) National Cancer Institute, is charged with monitoring the development and execution of the activities of the National Cancer Program and reporting to the president on progress, efficacy, and opportunities for improvement in the national effort against cancer. The Panel was established by law through the National Cancer Act of 1971.”
  • Per a GAO news release,
    • “Congress created USPS to be financially self-sufficient. However, USPS has lost billions since 2007 as people use mail less and costs increase. As a result, USPS’s financial viability has been on our High Risk list since 2009.
    • “USPS has tried to improve financially by raising prices and making operational changes. Congress also passed legislation to reduce some of USPS’s expenses. More must be done. But USPS hasn’t projected how its changes, like transporting more mail on trucks, may affect its future revenue, expenses, and more. USPS and Congress need these projections to determine what other steps to take. Our recommendation addresses this.”

From the Food and Drug Administration front,

  • Biopharma Dive reports,
    • “The Food and Drug Administration on Monday granted a key approval for AstraZeneca and Daiichi Sankyo’s Enhertu, clearing a regimen involving the drug as an initial treatment for HER2-positive breast cancer. 
    • “The approval issued Monday comes well ahead of the FDA’s Jan. 23 decision deadline and greenlights a combination of Enhertu and Roche’s targeted therapy Perjeta for frontline use in people whose metastatic breast cancer is confirmed to be HER2-positive by an FDA-approved test. The clearance is based on results published in the New England Journal of Medicine earlier this year, which showed the Enhertu-Perjeta regimen was more beneficial than the current first-line standard, a combination of chemotherapy and precision drugs that’s known as THP.” 
  • MedTech Dive notes,
    • “The Food and Drug Administration received more than 100 comments after seeking responses on how to monitor the real-world performance of artificial intelligence in medical devices. 
    • “The feedback diverged, with patients calling for stronger postmarket reporting and medical groups saying reporting should be the responsibility of manufacturers. Device companies, meanwhile, called for the FDA to use its existing regulatory frameworks instead of introducing new requirements.
    • “The FDA’s emphasis on real-world performance comes as the agency considers how to regulate increasingly complex technologies, such as generative AI, and how to ensure the performance of AI models doesn’t degrade over time.” 

From the public health and medical / Rx research front,

  • Per HHS news releases,
    • “The U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today approved the addition of Duchenne Muscular Dystrophy (DMD) and Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP) following scientific review and public comment. Early detection of both conditions allows children to receive FDA-approved therapies at the most effective time, helping to slow disease progression and preserve their quality of life.
    • “As my uncle has said, ‘although children may be the victims of fate, they will not be the victims of our neglect,’” said Secretary Kennedy. “This action honors that principle. Early screening gives every child a fair chance at timely, effective care, and it delivers families the answers and treatment options they deserve—right when they need them most.”
  • and
    • “The Centers for Disease Control and Prevention (CDC) today adopted individual-based decision-making for hepatitis B immunization for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. For those infants not receiving the birth dose, it is suggested that the initial dose be administered no earlier than two months of age.” * * *
    • “The CDC is reviewing ACIP’s secondary recommendation that parents should consult with a health care provider on serology testing to determine whether a subsequent hepatitis B vaccine dose is needed. For infants born to mothers who test positive for hepatitis B or whose status is unknown, the currently recommended birth dose of hepatitis B vaccine and immunoglobulin continues with no change.
    • “The adoption of individual-based decision-making for hepatitis B immunization maintains consistency of coverage through all payment mechanisms, including entitlement programs such as the Vaccines for Children Program, Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal Health Insurance Marketplace.
    • “Fact Sheet: Hepatitis B Immunization“
  • Per MedTech Dive,
    • “The Centers for Medicare and Medicaid Services will reconsider its national coverage determination for transcatheter aortic valve replacement in response to a request from Edwards Lifesciences, according to an agency posting on Monday.
    • “Edwards, in a July letter, asked the agency to reconsider its current policy for TAVR patients who are Medicare beneficiaries to reflect new evidence demonstrating improved outcomes when the valves are used to treat asymptomatic patients. Those patients are currently beyond the scope of Medicare coverage for the treatment.
    • “Analysts expect expanded Medicare coverage to drive further adoption of TAVR. William Blair analyst Brandon Vazquez said one-third of severe aortic stenosis patients are estimated to be asymptomatic. Broader reimbursement could also prompt more hospitals to open TAVR centers, Vazquez said.”
  • The New York Times reports,
    • “For a while, it seemed the notion that light drinking was good for the heart had gone by the wayside, debunked by new studies and overshadowed by warnings that alcohol causes cancer.
    • “Now the American Heart Association has revived the idea in a scientific review that is drawing intense criticism, setting off a new round of debate about alcohol consumption.
    • “The paper, which sought to summarize the latest research and was aimed at practicing cardiologists, concluded that light drinking — one to two drinks a day — posed no risk for coronary disease, stroke, sudden death and possibly heart failure, and may even reduce the risk of developing these conditions.
    • “Controversy over the influential organization’s review has been simmering since it was published in the association’s journal Circulation in July.”
  • Per Fierce Pharma,
    • “With a second late-stage trial win for its investigational HIV combo in the books, Gilead Sciences is moving full steam ahead toward regulatory filings for the novel HIV regimen.
    • “In Gilead’s Artistry-2 study, the company’s single-tablet regimen of bictegravir and lenacapavir matched up to Gilead’s own megablockbuster HIV medicine Biktarvy when assessing patients’ treatment responses, Gilead said in a Dec. 15 release. The trial enrolled adults with HIV who had achieved virologic suppression on Biktarvy and randomized them 2-1 to either switch to the novel regimen or continue receiving Biktarvy.”
  • Per MedPage Today,
    • “More than 70% of patients with advanced triple-negative breast cancer (TNBC) responded to an investigational bispecific antibody targeting PD-L1 and VEGF-A plus chemotherapy, a preliminary study showed.
    • “Overall, 71.8% (61.5% confirmed) of patients had partial responses to either of two dose levels of pumitamig plus nab-paclitaxel (Abraxane), and 23.1% had stable disease, resulting in a disease control rate of 94.9%. Tumor shrinkage occurred in all but five evaluable patients, averaging 42.6% for the entire cohort.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “With COVID sales falling and patent protections expiring, Pfizer is forecasting its 2026 revenue to be in the range of $59.5 billion to $62.5 billion. The midpoint of the projection ($61 billion) would be a decline from this year’s estimated revenue of $62 billion—which the company reaffirmed on Tuesday. It would also be an additional slide from Pfizer’s 2024 revenue of $63.6 billion.
    • “Built into the 2026 guidance is a $1.5 billion decline in sales of its COVID products—from an estimated $6.5 billion this year to $5 billion in expected sales next year. The company also expects to sustain a $1.5 billion hit from the loss of exclusivity (LOE) of its products.
    • “As those LOEs escalate in the coming years—to $3 billion-plus in 2027 and $6-plus in 2028—the drugmaker said that it doesn’t expect to see growth until 2029.”
  • Modern Healthcare relates,
    • “Medline Inc. raised $6.26 billion in the year’s biggest initial public offering, upsizing the deal and pricing the shares near the top of the marketed range.
    • “The company sold 216 million shares Tuesday for $29 each, according to a statement confirming a Bloomberg News report. Medline, which counts Blackstone Inc., Carlyle Group Inc. and Hellman & Friedman among its backers, had marketed 179 million shares for $26 to $30 each.
    • “The pricing gives the company a market value of about $39 billion, based on the number of shares listed in its filings with the U.S. Securities and Exchange Commission.
    • “Medline manufactures and distributes medical supplies such as gloves, gowns and exam tables used by hospitals and doctors. The three private equity firms sealed a $34 billion deal to acquire a majority stake in the company in 2021, in one of the largest leveraged buyouts of all time.” 
  • and
    • “City of Hope has opened Orange County’s first hospital exclusively dedicated to cancer care, marking a major milestone in the organization’s commitment to increasing access to advanced cancer treatment and research across the country. 
    • “The cancer specialty hospital, which began seeing patients Dec. 1, sits on City of Hope Orange County’s 72-acre academic campus in Irvine, California, and is connected to City of Hope Orange County Lennar Foundation Cancer Center, which opened in 2022. The opening completes a full continuum of cancer services in the region, enabling patients to access advanced inpatient and outpatient care, clinical trials and surgical oncology services without having to leave the region. Before City of Hope arrived in Orange County, as many as 20% of local cancer patients left the area to receive advanced cancer care, according to the organization. 
    • “We want every person to have options and access to the most skilled teams, the most cutting-edge treatments and the best research to give them the best chance of survival — this new hospital is part of that journey,” said Robert Stone, CEO of City of Hope.”
  • Per Healthcare Dive,
    • “Cencora is acquiring a majority stake in OneOncology, a support platform for cancer care practices, for $5 billion as the drug distributor ramps up its specialty services offerings.
    • “Cencora already owned a stake in OneOncology, but has signed a definitive agreement to acquire most of the remaining shares from investment firm TPG and other holders for $3.6 billion, and to pay off $1.3 billion of OneOncology’s debt.
    • “OneOncology’s practices will retain a minority interest in the company, according to a release. Cencora expects deal to close by the second fiscal quarter next year.”
  • Beckers Clinical Leadership points out,
    • “Concierge and direct primary care models are rapidly reshaping the U.S. primary care landscape. These membership-based practices, which charge monthly or annual fees for enhanced access and longer visits, have increased in recent years — often operating outside the traditional insurance system.
    • “A research article published in December in Health Affairs by researchers from Baltimore-based Johns Hopkins University, Portland-based Oregon Health & Science University and Boston-based Harvard Medical School found that such practices increased by more than 80% between 2018 and 2023, raising questions about equity, access and the future of the physician workforce.”
  • Lockton issued its 2025 high cost claimant report.
    • “Approximately 1% of an employer’s health plan members have annual claims higher than $100,000, but they account for 33% of total spend. And claims are growing more severe, complex, and unpredictable.
    • “Approximately 1% of an employer’s health plan members have annual claims higher than $100,000, but they account for 33% of total spend. And claims are growing more severe, complex, and unpredictable.”
    • “What’s changing is not only the magnitude of these claims, but also the instability. Only 21% of high-cost claimants (HCCs) persist year over year, increasing renewal uncertainty and complicating forecasting.”
  • Per an Institute for Clinicial and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of semaglutide (injectable Wegovy®, and a yet to be approved oral formulation) (Novo Nordisk) and tirzepatide (Zepbound®) (Eli Lilly and Company) for the treatment of obesity. The final report includes key policy recommendations to help ensure fair access.
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations “