Monday report

No Surprises Act

Monday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, No Surprises Act, Obesity, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “President Donald Trump is directing nearly a dozen federal agencies that provide public-facing benefits and services to crack down on fraudulent payments.
    • “Trump signed an executive order on Monday launching a task force to crack down on fraudulent payments across the federal government.” * * *
    • “Vice President J.D. Vance will serve as chairman of the fraud task force. The head of the Federal Trade Commission, Andrew Ferguson, will serve as its vice chairman.”
  • Bloomberg Law adds,
    • Lawmakers and the administration are stepping up scrutiny of overpayments in Medicare Advantage plans in a sign that Republicans increasingly could be willing to crack down on how much insurers are reimbursed for seniors’ health care. 
    • Medicare Advantage plans can offer additional benefits that traditional Medicare doesn’t cover, like dental, vision, or fitness classes, which have likely contributed to the rising popularity of the program among seniors. The Trump administration in January proposed keeping the private health insurance plans funded at an essentially flat rate of 0.09% for 2027. The proposal sent a shock through the health care market, and insurers warned without more funding, the program won’t cover sharply rising medical costs for seniors in 2027.
    • While the administration controls the annual funding rate, Congress established Medicare Advantage’s funding framework and still has power to overhaul the payment system, which lawmakers are looking into. 
  • Here’s the background on this Wednesday’s Congressional hearing about “Lowering Health Care Costs for All Americans: An Examination of the U.S. Provider Landscape.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services March 16 announced it will transition later this year to a new centralized platform for managing federal independent dispute resolution operations related to the No Surprises Act. CMS will move from single-use web forms to the platform, called the IDR Gateway, which the agency said will allow users to start and respond to disputes; access dispute dashboards and reports associated with their organization; track dispute information, including disputes assigned to a certified IDR entity; monitor assigned disputes by process phase; and review notifications regarding dispute activity. CMS said the platform would also include new security features, including identity verification processes and protocols that would permit only U.S.-based users to access the federal IDR process.” 
  • FedSmith offers federal and postal retirees practical tips about controlling rising healthcare costs.
  • Beckers Hospital Review tells us,
    • “The third round of the Medicare Drug Price Negotiation Program is moving forward with full manufacturer participation.
    • “The program, created under the Inflation Reduction Act, allows CMS to directly negotiate prices for high-expenditure, single-source drugs covered by Medicare Part B and Part D that lack generic or biosimilar competition. The negotiated prices are scheduled to take effect in 2028.
    • “The manufacturers of all 15  drugs selected for the third round have agreed to participate in the negotiation program, along with the manufacturer of one drug selected for renegotiation, according to a March 13 news release from CMS.”
  • and
    • “CMS will award up to $100 million to fund as many as 30 pilot programs through its voluntary initiative focused on lifestyle medicine.
    • “[The first two of] six things to know:
      • 1. The agency plans to award up to 30 three-year cooperative agreements totaling as much as $100 million to organizations focused on “evidence-based, whole-person functional or lifestyle medicine interventions” to launch programs that enhance conventional healthcare, according to a March 13 CMS news release shared with Becker’s.
      • 2. The funding opportunity is part of the Make American Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence, or ELEVATE, model, which CMS unveiled in December. The initiative will fund up to 30 chronic disease prevention and health promotion pilot projects aimed at integrating lifestyle and evidence-based functional medicine into original Medicare. 
  • Fierce Pharma informs us,
    • “The White House’s direct-to-consumer (DTC) platform, TrumpRx, is steadily expanding its catalogue, with products from GSK and Amgen the latest to join the collection of drugs offered through the program. 
    • “Amgen’s Humira biosimilar Amjevita, migraine med Aimovig and cholesterol drug Repatha became available through TrumpRx on Monday. GSK, meanwhile, is offering DTC discounts on several of its Ellipta inhalers and its flu treatment Relenza through the platform. 
    • “Amjevita can be purchased by cash-paying patients for $299 per month, an 80% discount to the med’s list price of $1,484. Aimovig and Repatha are discounted by 62% off their respective list prices, according to the website.” * * * 
    • “The new additions bring the total of medications offered through TrumpRx to 54 drugs.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “A federal judge on Monday blocked the Trump administration from implementing its pared-down list of recommended childhood vaccines.
    • “The new guidelines were part of Health and Human Services Secretary Robert F. Kennedy Jr. overhaul of the country’s immunization policies. But Judge Brian E. Murphy, a Biden appointee in Massachusetts, said the government appeared to have improperly bypassed the vaccine advisory panel to change the recommendations. 
    • “Murphy said that was “both a technical, procedural failure itself and a strong indication of something more fundamentally problematic: an abandonment of the technical knowledge and expertise embodied by that committee.” 
    • “Murphy said the government also improperly replaced all the committee members with new appointees, who made other changes last year to vaccine recommendations. Murphy blocked the votes taken by the Advisory Committee on Immunization Practices from taking effect and put on hold the new committee appointments. 
    • “He didn’t block the panel from meeting as planned on Wednesday and Thursday, but said the meeting in practice won’t be able to take place. The committee “as currently constituted cannot meet, for how can a committee meet without nearly the entirety of its membership?” he said.”
  • Per a Justice Department news release,
    • “Two owners of a pharmaceutical wholesale company were sentenced Friday to a total of 38 years in prison for orchestrating a complex, nationwide drug diversion scheme that harmed vulnerable HIV-positive patients, placed countless others at risk, and corrupted the supply chain for prescription drugs in the United States.
    • “Patrick and Charles Boyd did not just commit fraud and cost taxpayers millions of dollars, they preyed upon some of the most vulnerable members of our society: HIV patients who depend on life-saving treatments to manage their disease,” said Assistant Attorney General A. Tysen Duva of the Justice Department’s Criminal Division. “Fraud schemes like this one undermine the integrity of our supply chain for necessary prescription drugs. These defendants will rightly spend years in prison for their reprehensible conduct, which took advantage of people for illicit profit. This case is another example of how the Criminal Division, our United States Attorney partner in the Southern District of Florida, and law enforcement will pursue and seek convictions of those who defraud our systems, endanger our citizens, and seek to line their pockets with fraud proceeds.”

From the public health, medical and Rx research front,

  • The Wall Street Journal reports,
    • “Cyndy Dowling struggled with her weight for decades until she found what she thought was a lifelong solution: a monthly injection of one of the popular new weight-loss drugs.
    • “The 69-year-old easily lost 60 pounds in the span of a year and a half. But in early 2025, something changed.
    • “The food noise started creeping back. Her weight began edging up. She had to start “dieting” again. Here’s the twist: She never stopped taking Wegovy, one of the so-called GLP-1 drugs.
    • “A year later, Dowling has regained 10 pounds and is back to relying on protein shakes for some meals, all while continuing her weekly injections. “I’m fighting it as much as I can,” says the retired government employee. “I feel like I’m trying to hold the reins on something I can’t really control.”
    • “We’ve all heard that stopping taking a GLP-1 medication for weight loss—such as semaglutide (marketed as Wegovy) and tirzepatide (sold as Zepbound)—often leads to rapid weight gain, with people returning to baseline in as little as 18 months.
    • “What you might not have heard: For some people, the return of hunger and thoughts of food come back leading to potential weight gain—even while they are still taking the drug, which mimics naturally occurring gut hormones, suppressing appetite and making people feel full faster.
    • “Most obesity doctors say they’ve seen patients in this boat. They say it’s not that the weight-loss medications become less effective. Rather it’s that the body’s biological pressure to regain weight kicks in.”
  • BeckMedPage Today notes,
    • “For patients with obesity and atrial fibrillation (Afib), GLP-1 receptor agonist drugs may be the weight loss approach that better addresses their arrhythmia, observational data suggested.
    • “People who came out of catheter ablation and got bariatric surgery, as opposed to initiating GLP-1 drug therapy postablation, had significantly higher odds of Afib readmission at 2 years (36.4% vs 45.3%, HR 1.37, 95% CI 1.21-1.56), according to Rutvij Patel, MD, of Creighton University in Omaha, Nebraska, and colleagues.
    • “Their analysis of a large trove of U.S. electronic medical records also showed other clinical endpoints favoring GLP-1 drugs over bariatric surgery:
      • Heart failure (HF) readmission (HR 1.51, 95% CI 1.23-1.84)
      • All-cause readmission (HR 1.55, 95% CI 1.32-1.82)
      • All-cause mortality (HR 2.53, 95% CI 1.33-4.80)
    • “These findings were notable given that the GLP-1RA [receptor agonist] cohort had a higher baseline prevalence of diabetes, hypertension, HF, and chronic kidney disease,” study authors reported in JACC: Clinical Electrophysiologyopens in a new tab or window. “These findings highlight the potential role of GLP-1RAs as an adjunct in rhythm management strategies and support the need for prospective randomized trials.”
  • Beckers Hospital Review adds,
    • “Since late 2022, rising uptake of GLP-1 medications for obesity has coincided with a decline in bariatric surgeries, according to a growing body of research.
    • “A study published March 4 in JAMA Surgery found the swelling popularity of GLP-1 drugs for obesity, such as Wegovy and Zepbound, is not slowing — unlike bariatric surgery volumes. More patients are preferring GLP-1 therapies over bariatric operations, according to past research.” * * *
    • “Between the fourth quarter of 2018 and the third quarter of 2025, GLP-1 prescriptions increased from 0.22% to 24.17%. The percentage of bariatric surgeries among adults declined from 0.17% in the fourth quarter of 2022 to 0.09% in the third quarter of 2025 — which equals a 46.4% decrease.”
  • and
    • Little Rock, Ark., topped WalletHub’s 2026 ranking of the most overweight and obese U.S. cities, while Honolulu ranked lowest on the list.
    • The personal finance website compared 100 of the most populated U.S. metropolitan areas across three dimensions: obesity and overweight, health consequences, and food and fitness.
    • WalletHub evaluated these dimensions using 19 metrics, ranging from the share of physically inactive adults to healthy-food access. Each metric was graded on a 100-point scale, with 100 representing the most overweight and obese. Each metropolitan area’s overall score was then based on the weighted average across all metrics.
    • The article identifies the ten U.S. cities with the highest rates of overweight and obesity and the ten U.S. cities with the lowest rates thereof.
  • The American Medical Association lets us know what doctors wish their patients knew about at home blood pressure measurement.
  • Per a National Institutes of Health news release,
    • “In a clinical trial supported by the National Institutes of Health (NIH), a research team found that administering weekly injectable extended-release buprenorphine for treatment of opioid use disorder (OUD) during pregnancy led to higher rates of abstinence from illicit opioids than buprenorphine given daily under the tongue (sublingual), one of the standard methods of treatment. Additionally, serious adverse events were less common in those receiving extended-release treatment. The findings, which support the use of this formulation of buprenorphine for treating OUD during pregnancy, were published in JAMA Internal Medicine.  
    • “These findings are clinically valuable for they show us that this injectable extended-release buprenorphine formulation is safe to use in pregnancy and results in better opioid abstinence outcomes compared to sublingual buprenorphine,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “This is especially relevant in the context of the ongoing opioid overdose crisis and public health emergency.” 
  • MedPage Today informs us,
    • “Although most sexually active adolescents within a large primary care network had received human papillomavirus (HPV) vaccination before sexual debut, 12% had not received any doses of the vaccine, and 9% had not completed the series.
    • “Young people who had not been vaccinated were disproportionately non-Hispanic white (49%) and commercially insured (59%).
    • “Factors at play might have included vaccine hesitancy and delayed decision-making rather than lack of access.”
  • Health Day points out,
    • “The secret to a healthy heart in your 50s might actually be found in the dental records of your 10-year-old self.
    • “A massive study from the University of Copenhagen found that poor oral health during childhood is a significant predictor of cardiovascular issues later in life.
    • “By tracking more than 568,000 Danish children born between 1963 and 1972, researchers discovered that those who suffered from multiple cavities or severe gum disease (gingivitis) as children were much more likely to experience heart attacks, strokes and clogged arteries as adults.
    • “Specifically, children with high rates of tooth decay had a 45% higher rate of heart disease as adults compared to those with healthy teeth.
    • “The study — being published April 1 in the International Journal of Cardiology — suggests that the link isn’t just about poor habits, but rather how the body reacts to long-term infection.”
  • and
    • “People who eat more ultra-processed foods tend to have lower bone density and a higher risk of hip fractures, researchers recently reported in The British Journal of Nutrition.
    • “For every 3.7 extra servings eaten per day, a person’s risk of hip fracture increases by nearly 11%, researchers found.
    • “That means every slice of frozen pizza, every bowl of breakfast cereal, every sugary soda and every ready-to-heat meal adds to a person’s risk of brittle, easily broken bones, researchers said.
    • “Ultra-processed foods can be easily found on any trip to the grocery store, and these findings add to concerns of how they may affect our bone health,” researcher Dr. Lu Qi, a professor of public health at Tulane University in New Orleans, said in a news release.” 
  • STAT News relates,
    • “A brain implant could help people type — using just their minds. 
    • “Two people with paralysis were able to type strokes on a virtual keyboard using an implant that decodes attempted finger movement, with one patient typing up to 80% as quickly as an able-bodied person, according to a new study. 
    • “Brain-computer interfaces have been shown to help patients communicate, often by tracking their eye movement or by decoding brain activity associated with speech or handwriting. However, researchers say that some patients are more familiar with a typical keyboard and may prefer to use that to communicate. That’s what researchers from Mass General Brigham Neuroscience Institute and Brown University attempted in their new study, published in Nature Neuroscience.
    • “What’s really important is having this array of options for every individual such that we can best fit where they’re placed, what diseases they have,” said Justin Jude, study author and postdoctoral researcher at Brown University.”
  • Per BioPharma Dive,
    • “A pill from Structure Therapeutics helped people in a Phase 2 trial in obesity lose as much as 15% of their body weight over 44 weeks, results that suggest the drug, aleniglipron, could be competitive with rival medications from Eli Lilly and Novo Nordisk. 
    • “Treatment was also associated with a lower rate of study discontinuations than what had been seen earlier, after Structure incorporated a new strategy involving a slower step-up in dosing. Structure said that only one enrollee who got a dose of 120 milligrams daily or higher dropped out because of a side effect.
    • “Structure shares rose as much as 6% in morning trading. Leerink Partners analyst David Risinger characterized the results as “best-in-class weight loss” data, while RBC Capital Markets analyst Trung Huynh wrote that the pill looks like “another potential oral option to the market that will be competing for share in the future” with Novo’s Wegovy pill and Lilly’s orforglipron, the latter of which could be cleared in the U.S. within weeks.”
  • and
    • “San Francisco-based CytomX Therapeutics impressed investors Monday with the latest results for its experimental antibody-drug conjugate in hard-to-treat, late-stage colorectal cancer.
    • “The fresh data come from a so-called expansion portion of an ongoing Phase 1 study, which has been testing CytomX’s “masked” ADC. This portion evaluated three doses of the drug, dubbed Varseta-M, and found the two highest had response rates of 20% to 32% and extended progression-free survival by 6.8 and 7.1 months. The most common treatment-related adverse event was diarrhea, which, CytomX said, was generally manageable and reversible. However, despite an updated prophylactic regimen, 10% of a group of 20 patients still experienced severe diarrhea.
    • “The company said more data will be announced at upcoming medical meetings this year, and plans to engage with the Food and Drug Administration to determine a study design to evaluate the medicine as a monotherapy in advanced colorectal cancer.”

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

  • The Wall Street Journal reports,
    • “Employer healthcare costs are projected to surge around 9.5% this year, the largest increase in at least 15 years.
    • “Companies are weighing options like self-insurance, changing plan designs, and pushing more costs to employees to manage rising expenses.
    • “Higher prices for care, expanding use of services and expensive prescriptions are driving cost increases.”
  • Fierce Healthcare relates,
    • “As hospitals reduced their spending on oncology treatments due to the increasing availability of biosimilars, the reimbursements they received from insurers did not drop at the same rate—allowing hospitals to claim greater margins as they increased their use of the treatments, according to a recent analysis published in JAMA. 
    • “The observational study linked the Blue Cross Blue Shield insurance data of more than 66,000 cancer patients receiving care with the average acquisition and actual reimbursement payments of more than 1,500 hospitals. Additional analyses took into account hospital characteristics, such as eligibility for 340B drug discounts, that could affect purchasing and reimbursement.” * * *
    • “The editorial’s authors wrapped their critiques with calls for policy interventions that would “lower spending more automatically, rather than leaving it to the discretion of insurers and hospitals,” such as those proposed by MedPAC in its June 2023 report.”
  • and
    • “UnitedHealthcare is expanding its doula benefit to employer plans nationwide, the insurance giant announced Monday.
    • “The company said in the announcement that it intends to continue expanding the reach of its Doula Support program to additional employer groups throughout this year and expects that 7.2 million members would be eligible by Jan. 1, 2027. 
    • “Through the program, patients can connect with doulas who provide additional emotional, physical and education support during a pregnancy and postpartum. Doulas can offer key guidance to prepare for delivery and during labor as well as supports for newborn care, UnitedHealth said.”
  • Fierce Pharma tells us,
    • “Eli Lilly scored $408 million in U.S. sales of eczema treatment Ebglyss in its first full year on the market in 2025. Now, with positive results from a phase 3 trial of the IL-13 inhibitor, the Indianapolis drugmaker is set up to make it available to a younger group of patients.
    • “The study, which included 363 patients ages 6 months to 18 years with moderate to severe atopic dermatitis, met its primary and key secondary endpoints by alleviating disease symptoms, while providing skin clearance and itch relief at Week 16, Lilly reported Monday. Participants received placebo or a weight-based dose of Ebglyss and were on topical steroids beginning two weeks before randomization and throughout the study.
    • “The trial achieved its primary endpoint as 63% of patients on Ebglyss achieved meaningful skin improvement compared to 22% of those on placebo, according to Lilly. The Eczema Area Severity Index (EASI) was used as a measurement tool, with 75% improvement from baseline considered “meaningful.” As a secondary measure, 39% of those on Ebglyss reached 90% improvement on the EASI index compared to 11% of the patients on placebo.” * * *
    • “Lilly said it plans to submit these data to U.S. and global regulators for a potential label update.” 
  • MedCity News informs us,
    • “Isaac Health, a virtual memory clinic, unveiled a new eight-week virtual group series on Wednesday to reduce the risk of dementia.
    • “The New York City-based startup works with healthcare organizations to provide screening, assessment, treatment and care management for people living with dementia. It’s in network with Medicare and major insurers across all 50 states, including UnitedHealthcare, Aetna and Humana.
    • “The new program — called the Lifestyle Medicine and Better Brain Health program — is intended for those proactively seeking to reduce dementia risk or slow cognitive decline, particularly those prone to dementia and their caregivers.
    • “The weekly sessions are led by clinicians and are available in individual, couple or family formats. They’re focused on a variety of strategies for brain health, including sleep, nutrition, physical activity, cognitive engagement, vascular risk factor reduction and stress management. The program can be covered by most insurers but depends on individual plan benefits.”
  • Kaufmann Hall offers an “Executive Dialogue: AI in action: Separating the hype from real value in strategy and planning.”
    • “Following a period defined by operational strain, workforce disruption and financial pressure, healthcare leaders are now turning their focus toward technologies that can help rebuild stability as they prepare for the future. Artificial intelligence is a central point of exploration for health systems seeking greater efficiency, improved patient experience and sustainable clinical operations.
    • “To gather real-world perspectives, the American Hospital Association’s Society for Health Care Strategy & Market Development (SHSMD) hosted an executive dialogue focused on the practical realities of AI adoption. Leaders from academic centers, community hospitals and Federally Qualified Health Centers shared insights on governance, workforce expectations, vendor strategy and how best to measure value in a technology environment evolving faster than most organiza­tions can absorb.
    • “As dialogue participants reflected on the evolving role of artificial intel­ligence across their organizations, four major themes emerged. The first was the growing need for clear AI governance, as health systems work to balance rapid innovation with responsible oversight. The sec­ond was workforce adoption, with leaders noting that even the most promising tools succeed or fail based on how well they fit into clinical and operational workflows. Third was the shifting vendor landscape, as organizations navigate the tension between emerging third-party solu­tions and rapidly advancing EHR-embedded capabilities. The fourth was the question of value — how to define, measure and communicate the impact of AI in a way that captures both operational gains and the broader transformation of care delivery.”

Thursday report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The New York Times reports,
    • “In his first week leading two of the nation’s health agencies, Dr. Jay Bhattacharya has been met with praise and gratitude from federal employees — an unexpected reception for a scientist who spent much of the last few years facing scorn from most other public health experts.
    • “Dr. Bhattacharya, director of the National Institutes of Health, was last week named the acting director of the Centers for Disease Control and Prevention. A medical economist and former Stanford University professor, he replaced Jim O’Neill, a Silicon Valley executive with no medical training.
    • “Like most officials in the Trump administration, Dr. Bhattacharya was staunchly opposed to mandates for Covid vaccines, but unlike many, he has not questioned the safety of childhood vaccines.
    • “In meetings with C.D.C. staff this week, Dr. Bhattacharya offered to publicly endorse immunizations in general and the measles vaccine in particular; extolled the importance of prevention efforts against H.I.V.; and promised to try to extend remote work accommodations, according to several C.D.C. employees with knowledge of the discussions.” 
  • Beckers Payer Issues informs us,
    • “HHS released its third annual report Feb. 9 that evaluates how the No Surprises Act has affected healthcare markets.
    • “The report was produced with analytical support from RAND, and extends claims data trends through 2022, the first full year after the law took effect.
    • “Because most self-insured employer plans were not previously subject to state surprise billing laws, the NSA represented a bigger regulatory change for them than for fully insured plans. Average out-of-network per-claim payments for emergency services in self-insured plans fell 41% during the period, compared to 22% for fully insured plans. Self-insured plans also saw steeper declines in out-of-network billing prevalence and out-of-pocket costs across the board.”
  • Avalere Health tells us,
    • “From 2025 to 2026, overall Part D enrollment increased from 55.4 million to 56.9 million (a 2.7% increase). Over this period, enrollment in PDPs grew by 7.2% while enrollment in MA-PDs decreased by 0.5%. This is a notable shift from trends in recent years. MA-PD enrollment had climbed from 26 million in 2022 to 31.8 million in 2025, with annual growth of 7.4% from 2023 to 2024 and 4.3% from 2024 to 2025. By contrast, PDP enrollment was stable at 23.4 million in 2022 and 23.5 million in 2025, before rising to 25.2 million in 2026.  
    • “PDP enrollees are increasingly selecting lower premiums plans. In 2026, 64% of PDP enrollees chose plans with premiums under $25, up from 49% in 2025. At the same time, the share selecting plans with premiums of $100 or more increased to 17% in 2026, up from 12% in 2025.” * * *
    • “Despite continued declines in the number of standalone PDPs offered in 2025 and 2026 relative to prior years, PDP enrollment has increased while MA-PD enrollment has largely leveled off. For plan sponsors, this divergence may signal changing beneficiary preferences around premium sensitivity, benefit offerings, pharmacy network design, and the value proposition of integrated MA coverage versus a standalone Part D product.” 
        
  • Federal News Network reports,
    • “The Agriculture Department is planning to sell one of its headquarters buildings, as part of an ongoing agency reorganization that will relocate more than half of its workforce in Washington, D.C. to regional hubs across the country.
    • “USDA announced Wednesday that it is turning the department’s South Building over to its landlord, the General Services Administration, which plans to sell the building.”
  • Tammy Flanagan, writing in Govexec, explains “How to make the most of FERS, Social Security and your TSP.”
    • “Understanding each part of your federal retirement can help you plan when and how to retire and avoid surprises.”
  • Govexec relates,
    • “Newly released data from the Government Accountability Office offers some of the most granular glimpses yet of how the Trump administration’s sprint to remake the federal workforce in the president’s image impacted agency headcounts.
    • “The report, published Tuesday, responds to a request by congressional Democrats to catalog data related to a variety of workforce changes undertaken shortly after President Trump returned to office last January, including reductions in force, the purge of recently hired or promoted employees with fewer civil service protections and the deferred resignation program.
    • “GAO said it relied upon data from the Office of Personnel Management and individual agencies in compiling its report. OPM has previously said that around 317,000 federal workers left government in 2025. The watchdog agency’s report captures the first six months of Trump’s second term, capturing a fraction of that throughput.
    • “Of the 134,122 employees who separated from the 23 CFO Act agencies during the period from January to June 2025, a substantial majority (around 77%) retired or resigned,” GAO found. “Another roughly 19% were terminated or removed from their positions. Of these, agencies reported that nearly 4,500 employees (or about 3%) were terminated during a probationary or trial period.”

From the Food and Drug Administration front,

  • ABC News reports,
    • “Frozen blueberries distributed in four states have been voluntarily recalled due to possible listeria contamination.
    • “Oregon Potato Company, which owns the Salem, Oregon-based Willamette Valley Fruit Company, voluntarily recalled 55,689 pounds of frozen blueberries on Feb. 12 over potential contamination with Listeria monocytogenes, according an enforcement report from the U.S. Food and Drug Administration.
    • “The recall was designated as a Class I recall on Feb. 24, the highest FDA classification, which indicates that “use of or exposure to” the affected product can cause “serious adverse health consequences or death.”
  • MedPage Today adds,
    • “The FDA approved dupilumab (Dupixent) for treating allergic fungal rhinosinusitis, a first for the condition, the agency announced on Wednesday.
    • “Approval stipulates use in individuals 6 years and older with prior sino-nasal surgery, as the condition has a high rate of post-operative recurrence.
    • “Allergic fungal rhinosinusitis is characterized by the production of thick, sticky mucus following an allergic reaction to fungi in the sinuses. Left untreated, the type 2 inflammatory disease can expand the sinuses, erode surrounding bone, and lead to vision problems, nerve damage, and even facial deformities.”

From the judicial front,

  • Govexec reports,
    • “A federal appeals court on Thursday declined to enforce a temporary decision blocking the Trump administration from stripping two-thirds of the federal workforce of their collective bargaining rights, dimming though not extinguishing the American Federation of Government Employees’ legal challenges against a pair of anti-union executive orders.
    • “A three-judge panel on the Ninth Circuit Court of Appeals ruled unanimously that it could not uphold a preliminary injunction that would have blocked the Trump administration from implementing a pair of 2025 executive orders that cite a seldom-used provision of the 1978 Civil Service Reform Act to ban collective bargaining at most federal agencies, under the auspices of national security. That injunction had itself been put on hold by the appellate judges since last August.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The last thing someone in their 30s or 40s should worry about is dying of a heart attack. But new research shows more are.
    • “The proportion of adults ages 18 to 54 who died in a hospital of a severe first heart attack rose 57% between 2011 and 2022, according to a new study published Thursdayin the Journal of the American Heart Association.
    • “Most of those who died were men, but women died at higher rates than men.
    • “The study offers the latest evidence of worsening health among younger U.S. adults, including deaths from conditions traditionally tied to aging, such as heart disease and cancer.”
  • The American Hospital Association News relates,
    • “Obesity rates for U.S. children and teenagers have reached record highs, while rates for adults had a slight decline, according to reports by the Centers for Disease Control and Prevention. Both reports examined historical trends using height and weight data from the National Health and Nutrition Examination Survey. From August 2021 to August 2023, an estimated 21.1% of children and teenagers ages 2-19 were obese, up from 19.3% from 2017-2018. Additionally, from 2021-2023, 7% of children and adolescents were severely obese and 15.1% were overweight. For adults, 40.3% were obese from 2021-2023, down from 42.8% in 2017-2018. In addition, from 2021-2023, 9.7% of adults were severely obese and 31.7% were overweight.”
  • BioPharma Dive tells us,
    • “Eli Lilly’s GLP-1 pill orforglipron was associated with greater weight loss and reductions in blood sugar levels than Novo Nordisk’s rival drug Rybelsus in a head-to-head trial in people with diabetes.
    • “The study results disclosed Thursday could help strengthen Lilly’s case for approval as well as orforglipron’s uptake in diabetes. But investigators also flagged higher rates of side effects in orforglipron recipients that led people to stop treatment. 
    • “The data highlight another potential threat to Novo, which has seen its shares tumble amid pricing pressure and competition from Lilly as well as drug compounders. The Denmark-based company markets the only oral GLP-1 medications for diabetes and obesity — Rybelsus and the Wegovy pill, respectively — but that could soon change. Lilly expects the Food and Drug Administration to decide whether to clear use of orforglipron in obesity sometime in the second quarter.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “A study by researchers at The Jackson Laboratory (JAX), the Broad Institute, and Yale University has identified how specific genetic changes function in cells to influence disease risk and other human health traits. By probing regions of DNA previously linked to disease, the scientists created high resolution maps of DNA variant activity, helping pinpoint the exact changes that shape blood pressure, cholesterol levels, blood sugar and other complex human traits.
    • “The study takes on a long-standing challenge in human genetics. Scientists have known for years that certain regions of the genome—often spanning tens of thousands to millions of DNA letters—are associated with diseases. But because these regions usually contain many variants that could potentially drive those associations, performing the necessary experiments to pinpoint which specific DNA changes truly matter has been difficult and time-consuming.
    • “The solution was scale. Using a massively parallel reporter assay (MRPA)—which is a high-throughput approach that simultaneously evaluates the regulatory activity of thousands of DNA sequences—the team tested more than 220,000 previously identified DNA changes in five different cell types. By doing so, they resolved about 20% of these regions across the genome, revealing new insights into what these variants do, which in turn could help improve risk prediction and guide the development of new therapies.
    • “Geneticist Ryan Tewhey, PhD, an associate professor who led the team at JAX, explained that previously making these connections was like searching for a single typo on one page of a massive book. The researchers’ new experimental approach is more akin to speed reading, scanning thousands of pages at once and flagging the exact letters that change meaning, dramatically accelerating genetic discovery.”
  • The Washington Post lets us know that “An all-or-nothing mindset could be hurting your exercise and health goals.
    • “If you’ve given up on your New Year’s resolutions to get fit, here are some tips for getting back in the saddle.”
  • MedPage Today adds,
    • “The cost of sunscreen with an SPF-50 rating varied by 17.5-fold per ounce and 100-fold per application in an economic analysis.
    • “Wearing more protective clothing could significantly reduce the amount of sunscreen needed and could lower application expenses.
    • “Standardization of sunscreen application to achieve desired thickness might influence annual cost.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Cigna has acquired CarepathRx, a large pharmacy backed by private equity that dispenses prescription drugs to nearly 10% of U.S. hospitals.
    • “The acquisition, discovered by STAT in a review of Cigna’s financial filings, reinforces the company’s push to control more of the lucrative flow of pharmaceuticals through the U.S. health care system. Cigna executives have repeatedly told investors that managing prescription drugs has been one of their highest priorities since the company acquired Express Scripts for $54 billion in 2018.”
  • Beckers Health IT relates,
    • “Two years after a merger that created a now $12.1 billion system, St. Louis-based BJC Health is rolling out fresh branding to solidify its market positioning and boost recruitment and retention, leaders told Becker’s.
    • “St. Louis-based BJC HealthCare and Kansas City, Mo.-based Saint Luke’s Health System joined forcesin early 2024, rebranding as BJC Health in late 2025. Now, the organization’s West region is in the midst of a new marketing campaign — “All For Kansas City” — and updating signage to bring the BJC brand to its market.
    • “The new logo puts an exclamation point behind the fact that the Saint Luke’s brand is here to stay, and, at the same time, connects us to BJC Health,” said Julie Quirin, president of BJC Health’s West region (aka Saint Luke’s Health System). “It tells the story that we’re stronger together, while leaning into that brand equity that we’ve built over the last 150 years here in Kansas City.”
  • Per Fierce Pharma,
    • “Already on a roll with its first-in-class FcRn blocker Vyvgart, argenx has reported successful trial results that could pave the way for the fast-rising blockbuster to reach a new indication—ocular myasthenia gravis.
    • “The phase 3 Adapt Oculus study, which is the first to specifically evaluate a targeted treatment for ocular myasthenia gravis (oMG), has achieved its primary endpoint, demonstrating that Vyvgart can improve vision by a statistically significant margin, argenx reported Thursday.
    • “The company hailed the victory the same day it unveiled its 2025 earnings, showing that Vyvgart sales came in at $1.3 billion in the fourth quarter and $4.2 billion for the full year.”
  • Per Healthcare Dive,
    • “Labcorp has expanded its collaboration with PathAI to use a digital pathology platform at its anatomic pathology labs and hospital sites.
    • “The agreement, which Labcorp disclosed Monday, supports the use of PathAI’s AISight Dx to enable digital workflows for case management, slide review, collaboration and annotation.
    • “Quest Diagnostics, Labcorp’s main rival, licensed AISight Dx in 2024 in conjunction with its $100 million acquisition of PathAI’s diagnostic laboratory in Memphis, Tennessee.”

Tuesday report

David Ermer–Congress, Employee Wellness Programs, FDA, Generative AI, NIH, No Surprises Act, Obesity, U.S. Healthcare–

From Washington, DC

  • Bloomberg Law reports,
    • “Another reconciliation bill represents a “tremendous opportunity”for Republicans to pass key policy priorities before the midterm elections, a House GOP tax-writer said Monday.
    • “Rep. Beth Van Duyne (R-Texas), a member of the House Ways and Means Committee, said at a Bloomberg Government roundtable that Republicans want a second shot at passing several provisions that were axed from their first reconciliation bill passed last year.
    • “It was a heavy lift to do reconciliation 1.0,” Van Duyne said. “But I think there’s a lot of parts of that bill that got washed out in the Byrd bath that we would like to be able to see put in reconciliation 2.0.” * * *
    • “Republican leaders including Ways and Means Chairman Jason Smith (R-Mo.) along with President Donald Trump have been cool to the idea of starting work on a second party-line bill given how challenging it was to pass the first bill, though a number of rank-and-file GOP lawmakers have clamored for it.
    • “There’s a lot of very strong bills that would be productive to be able to have passed and the only way that we can do that is put it in reconciliation,” Van Duyne said.”
  • and
    • “More than three dozen employers, insurers, and patient advocacy groups are askingthe Trump administration to intervene in the arbitration process for surprise medical bills. 
    • “Dysfunction under the No Surprises Act has flooded the courts with cases of alleged fraud on both sides. Insurers accuse providers of knowingly submitting ineligible claims to the arbitration process, while providers allege insurers are misleading arbitrators on key payment metrics.
    • “Health insurance companies and employers are losing the vast majority of cases under the law. Data from the Centers for Medicare & Medicaid Services, which oversees the arbitration process, show that providers are winning 88% of the time. But courts are largely siding with insurers when providers allege they aren’t paying up, saying that enforcement resides with the CMS.
    • “The Office of Management and Budget is reviewing a final rule to improve the independent dispute resolution process, which requires arbitrators to settle out-of-network bills between doctors and insurers. The rule has languished since the Department of Health and Human Services first proposed it in November 2023 as a series of legal challenges from the Texas Medical Association unfolded in the courts.
    • “More transparency and accountability is needed for companies that oversee arbitration, the ERISA Industry Committee, American Benefits Council, Business Group on Health, Elevance Health, union 32BJ Health Fund, and others said in a letter Tuesday.”
  • FEHBlog note — With regard to transparency, one of the factors that the arbitrators consider is patient acuity. A health plan can only guess at that factor. That’s unreasonable. The arbitration process should better align with American Arbitration Association rules for baseball arbitration.
  • Mobihealth News relates,
    • “Dr. Mehmet Oz, administrator of the Centers for Medicare and Medicaid Services (CMS), said during an Action for Progress event focused on addiction and mental health that AI avatars are the best way to help rural communities access mental healthcare.
    • “We do not have enough practitioners for mental health support in these areas,” Dr. Oz said during the event.
    • “I’m telling you right now. There’s no question about it – whether you want it or not – the best way to help some of these communities is going to be AI-based avatars.”
    • “He proposed using agentic AI with the ability to conduct early mental health intakes, customize support to a patient’s needs and understand what a patient is “up to.”  
    • “[These tools] will pick up subtle little nuances in how you’re saying things – if you do it on purpose, it’s actually cool to find out – that will alert the avatar, but more importantly, the doctor they are going to report to that there is something going on,” Oz said. “And there will always be a doctor.”
    • “He framed the use of AI avatars to be used in conjunction with clinicians as, he said, humans are biologically designed to interpret facial cues, such as happiness, boredom, excitement and more, before a person verbalizes it.
    • “The key question is how do we use AI thoughtfully in that setting? If we do it right, we’ll build a much more sustainable healthcare system around mental health issues,” Oz said.”  

From the Food and Drug Administration front,

  • Fierce Pharma reports
    • “Four years after the FDA issued its most heavy-handed form of a rejection to the prior company behind pegzilarginase, the U.S. regulator has now given the treatment a thumbs-up.
    • “Scoring the accelerated nod is Immedica Pharma for Loargys as a therapy for hyperargininemia in the ultrarare genetic disorder Arginase 1 deficiency (ARG1-D). The approval covers patients age 2 and older, with the therapy to be used in conjunction with a protein-restricted diet. 
    • “Loargys, which is also known as pegzilarginase, is a recombinant human enzyme designed to lower levels of arginine in patients who are unable to break down the amino acid. It is the first treatment to address the elevated levels of plasma arginine associated with the disorder.”
  • and
    • “Sanofi and Regeneron’s megablockbuster immunology drug Dupixent has gained yet another FDA approval, this time in allergic fungal rhinosinusitis (AFRS).
    • “The U.S. regulator signed off on the drug as a treatment for adults and children ages 6 and older with AFRS based on late-stage trial data showing Dupixent reduced nasal signs and symptoms and systemic corticosteroid use or surgery compared to placebo, according to a Feb. 24 press release.” * * *
    • “Harmony Biosciences is rounding out the U.S. patient pool eligible for its sleep disorder pill Wakix after notching a pediatric nod from the FDA that positions the drug as a treatment for cataplexy in people ages 6 and older with narcolepsy.
    • “The new addition to Wakix’s label makes it the only non-scheduled treatment for both adult and pediatric narcolepsy patients in the U.S. with or without cataplexy. That non-scheduled classification represents an “important distinction that supports its clinical utility,” Harmony’s CEO, Jeffrey Dayno, M.D., commented in a press release. Cataplexy is a common symptom of narcolepsy that involves a sudden weakening of muscles, often when triggered by a strong emotion.” * * *
    • “Two months after Johnson & Johnson’s Rybrevant Faspro picked up its first FDA approval, the subcutaneous lung cancer drug has scored a label expansion to be given monthly.
    • “On Tuesday, J&J touted a “simplified” monthly dosing regimen for the drug’s combination with lazertinib for the first-line treatment of epidermal growth factor receptor EGFR-mutated advanced non-small cell lung cancer. Previously, the combo was approved as an every-two-week regimen.”
  • and
    • “Just three months after further scaling back its support for the struggling hemophilia A gene therapy Roctavian, the company is walking away altogether by pulling the treatment from the market. 
    • “The move follows a “comprehensive effort” to identify a potential buyer for the therapy, BioMarin explained Monday in its fourth-quarter earnings press release.” 

From the public health and medical / Rx research front,

  •  Health Day relates,
    • “You don’t need to look buff or tough, but muscle strength can influence how long you’ll live, a new study says.
    • “Older women with greater strength had a significantly lower risk of death during an eight-year follow-up, researchers recently reported in JAMA Network Open.
    • “The study measured women’s grip strength and ability to rise from a seated to standing position — two tests commonly used to determine seniors’ strength levels.
    • “Women had a 12% lower death rate for every 15 additional pounds of grip strength they exhibited during testing, researchers found.
    • “Likewise, they had a 4% lower death rate for every 6 seconds faster they could complete five sit-to-stand chair raises, results showed.”
  • and
    • “Teens who use weed are twice as likely to develop psychotic or bipolar disorders, a new study says.
    • “They also are more likely to have depression and anxiety, researchers reported Feb. 20 in JAMA Health Forum.
    • “As cannabis becomes more potent and aggressively marketed, this study indicates that adolescent cannabis use is associated with double the risk of incident psychotic and bipolar disorders, two of the most serious mental health conditions,” researcher Dr. Lynn Silver said in a news release. She’s a program director at the Public Health Institute in Oakland, California.
    • “More than 10% of 12- to 17-year-olds in the U.S. have used weed within the past year, researchers said in background notes. By their senior year in high school, about 26% of U.S. teenagers have tried it.”
  • and
    • “Side effects like nausea or vomiting are common among folks taking Ozempic/Wegovy, but they’ll grin and bear it if they think they’re losing weight, a new study finds.
    • “The drugs’ perceived effectiveness — lost weight, less appetite, fewer food cravings — outweigh GI side effects, researchers reported recently in the Journal of Medical Internet Research.”
  • MedPage Today informs us,
    • “Hepatitis B vaccination rates among U.S. newborns have fallen by more than 10 percentage points over the past 2 years.
    • “Those rates climbed steadily for 6 years, peaking at 83.5% in February 2023 before dropping to 73.2% by August 2025.
    • “The drop began months before the CDC’s Advisory Committee on Immunization Practices voted in December to stop universally recommending the birth dose.”
  • and
  • Per an NIH news release,
    • “A study funded by the National Institutes of Health (NIH) reduced new HIV cases by 70% in rural Kenya and Uganda by pairing digital tools with tailored HIV services delivered by community health workers and clinicians. This successful strategic implementation of existing healthcare infrastructure and available HIV prevention and treatment options could become a model for reducing HIV incidence in other countries, including the United States. The findings were presented today at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver.”  
  • Here’s a link to the latest edition of NIH’s Research Matters which covers the following topics:

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

  • The Wall Street Journal reports,
    • Novo Nordisk NOVO.B plans to slash U.S. list prices for its popular weight-loss and diabetes drugs Wegovy and Ozempic by up to half starting next year.
    • Under the changes, both Ozempic and Wegovy will list for $675 a month, effective Jan. 1, 2027. That is half of the current price tag for anti-obesity therapy Wegovy and a 34% cut for diabetes treatment Ozempic. The price cuts also will apply to pill versions of both injections, including one sold as Rybelsus.
    • The reductions escalate a price war with rival Eli Lilly LLY -1.40% in one of the fastest-growing, most hotly contested categories in pharmaceuticals.
  • Optum Rx, writing in LinkedIn, discusses the next phase of the GLP-1 revolution.
  • STAT News relates,
    • “In the last year and a half, direct-to-consumer telehealth company Hims & Hers has become a leading voice in the debate over compounded GLP-1 weight loss medications. On Monday, it announced earnings from the last quarter of 2025 after a whirlwind month that raised questions about the regulatory risks of the company’s compounding model and the threat of an investigation. 
    • “In the call, Hims & Hers CEO Andrew Dudum addressed the increased scrutiny on compounded GLP-1s and its impact on the business’s bottom line, emphasizing Hims’ other medications, including for weight loss. “We believe there’s a really durable weight business,” said Dudum, “even if you think you’re kind of in a draconian scenario of compounding GLP-1s not being there.”
  • Fierce Healthcare tells us,
    • “Employers are spending more on women’s and family health, but that is not always being felt by employees, a new report finds.
    • “The Maven Clinic released its fifth annual State of Women’s & Family Health Benefits report, which is based on responses from over 2,000 HR leaders and nearly 5,000 full-time employees across the U.S., U.K., Canada and India. The report highlights how rising healthcare costs are reshaping how employees seek care and what actions employers are considering to help address those costs.
    • “Though employers reported a 39% average increase in women’s and family health benefits offered year-over-year, the share of employees who felt their benefits support them “very well” dropped 10% on average. Globally, across all benefits, employers were slightly more likely to add or enhance benefits in the next year compared to those in the U.S.”
    • “From Maven’s perspective, all the report’s findings highlight the need for an integrated approach to benefits and care delivery.
    • “We think that the category continues to show importance, and that is a positive,” Stephanie Glenn, chief commercial officer at Maven, told Fierce Healthcare. 
    • “But the gap in what’s being offered and what employees are feeling exists because of a lack of thoughtful integration, she added. “Unless it’s a coordinated offering, if you get a one-time email about a new benefit, it’s very disjointed. You don’t understand what it looks like,” she said.”
  • Healthcare Dive tells us,
    • “Thirty-one thousand Kaiser Permanente nurses and other healthcare professionals in California and Hawaii ended a major strike Tuesday after about a month on the picket lines. 
    • “In a statement Monday, the workers’ union, the United Nurses Associations of California/Union of Health Care Professionals, said “significant movement” at the bargaining table over the past two days prompted leaders to end the strike.
    • “Returning members to their patients and their livelihoods is the clearest path to securing a final agreement and building on the progress achieved during the strike,” the UNAC/UHCP said.”
  • and
    • “Home health and hospice provider Enhabit has agreed to be taken private by private equity firm Kinderhook Industries in a deal worth $1.1 billion.
    • “Under the deal terms announced Monday, shareholders will receive $13.80 in cash per share, representing an almost 25% premium over Enhabit’s closing stock price on Feb. 20. 
    • “The Dallas-based provider — which has almost 250 home health locations and over 115 hospice locations in 34 states — will cease trading on the New York Stock Exchange when the deal closes, which the companies expect to happen in the second quarter this year.”
  • Beckers Hospital Review notes,
    • “For the first time, women now make up the majority of physicians in U.S. training programs, according to the Association of American Medical Colleges’ annual report on residency trends. 
    • “In the 2024-25 academic year, women accounted for 50.2% of residents and fellows across all specialties and subspecialties, per the report. The figure marks a stark contrast from the 1970s, when women comprised less than 10% of physicians, and reflects decades of steady growth in female representation in medical schools and training programs.”
  • and
    • “If healthcare IT were golf, CIOs would take a few mulligans.
    • “Choosing and installing an EHR is often one of the biggest, most complicated decisions IT leaders will ever make, and some executives told Becker’s they would do things differently if they could go back in time.”
  • Per MedTech Dive,
    • “Medtronic on Tuesday priced a planned initial public offering for its MiniMed diabetes spinoff at up to $784 million.
    • “MiniMed plans to price its IPO between $25 and $28 per share across 28 million shares. Underwriters will also have the option to buy an additional 4.2 million shares at the IPO price.
    • “Medtronic first announced plans to spin out its diabetes business into a separate, publicly traded company in May. The new firm would be the only company in the market that sells both insulin pumps and continuous glucose monitors.”

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump demanded Monday that House lawmakers back the bipartisan spending deal passed by the Senate last week and set aside policy demands in an effort to quickly end a partial government shutdown. 
    • “We need to get the Government open, and I hope all Republicans and Democrats will join me in supporting this Bill, and send it to my desk WITHOUT DELAY,” Trump posted on Truth Social. “There can be NO CHANGES at this time.”
    • “House Speaker Mike Johnson (R., La.) is trying to pass as soon as Tuesday the $1.2 trillion package that funds large parts of the federal government through the end of the fiscal year while funding the Department of Homeland Security for just two weeks. That short-term extension is designed to provide time for a bipartisan deal to be reached on stricter policies for immigration-enforcement agents.” 
  • The American Hospital Association (AHA) News tells us,
    • “The Department of Health and Human Services today announced a new behavioral health initiativeto assist homeless individuals with substance use treatment and recovery. The program, called the Safety Through Recovery, Engagement, and Evidence-based Treatment and Supports, or STREETS, will focus on psychiatric care, medical stabilization and crisis intervention, HHS said. The initiative is tied to an executive order issued by the administration last week on substance use.” 
  • In January 2024 OPM proposed to create to advance the FEHB / PSHB eligibility date to the first day of employment.  AFHO, the trade association that the FEHBlog represents, used the public comment period to advocate for the HIPAA 820.  Today, in a welcome deregulatory step, OPM withdrew the proposed rule.
  • MedCity News considers whether “It is Time to Change the Independent Dispute Resolution Process of the No Surprises Act.” The FEHBlog thinks so because the current process is opaque.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Grail has filed for Food and Drug Administration approval of its multi-cancer early detection test, the company said Thursday.
    • “The premarket approval filing for Grail’s Galleri test focuses on a U.S. study of more than 25,000 people and a randomized, controlled trial the company is running in the United Kingdom.
    • “Grail President Josh Ofman said at an event in January that approval will be a “major trigger” for evidence-based decisions with U.S. payers and could enable Medicare coverage.”
  • Cardiovascular Business relates,
    • “eMurmur, an Ontario-based artificial intelligence (AI) startup, has received U.S. Food and Drug Administration (FDA)clearance for its suite of algorithms designed to evaluate heart recordings captured by digital stethoscopes. 
    • “The newly approved offering, eMurmur Heart AI, was designed to detect both the presence and absence of heart murmurs. In addition, it can provide hemodynamic data that helps care teams as they develop patient management strategies. eMurmur Heart AI can be accessed through the company’s own standalone software—available as a web platform or mobile app—or through a third-party system.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “The Centers for Disease Control and Prevention released its annual progress report on health care-associated infections Jan. 29, which found continued decreases in hospitalizations from multiple infections last year. Among the findings, there was an 11% decrease in hospital-onset Clostridioides difficile, or C. difficile, infection; a 10% decrease in catheter-associated urinary tract infections, or CAUTI; a 9% decrease in central line-associated bloodstream infections, or CLABSI; and a 7% decrease in hospital-onset methicillin-resistant Staphylococcus aureus, or MRSA. 
    • “Among inpatient rehabilitation facilities, there was an 18% decrease in hospital-onset C. difficile infections and an 8% decrease in CAUTI. For long-term care hospitals, there was a 23% decrease in ventilator-associated events and a 15% decrease in hospital-onset C. difficile. The report recommended providers continue reinforcing prevention practices, review HAI surveillance data to identify areas for improvement and address any gaps in prevention practices.”
  • Cardiovasular Business relates,
    • “Researchers have developed a new injectable therapy that could help protect a patient’s brain after they experience a stroke. The team behind this new treatment shared a look at its early progress in Neurotherapeutics.
    • “The therapy in question was built to cross the blood-brain barrier and help repair brain tissue, limiting the risk of permanent brain damage and encouraging a healthy recovery following an ischemic stroke. Co-author Samuel Stupp, PhD, founding director of Northwestern University’s Center for Regenerative Nanomedicine, previously found that supramolecular therapeutic peptides (STPs) technology could reverse paralysis and repair tissue in mice after a single injection. This analysis took those observations related to the potential benefits of STPs and transferred them to a new area of medicine. 
    • “Current clinical approaches are entirely focused on blood flow restoration,” co-author Ayush Batra, MD, an associate professor with the Northwestern University Feinberg School of Medicine and co-director of the NeuroVascular Inflammation Laboratory at Northwestern, said in a statement. “Any treatment that facilitates neuronal recovery and minimizes injury would be very powerful, but that holy grail doesn’t yet exist. This study is promising because it’s leading us down a pathway to develop these technologies and therapeutics for this unmet need.”
  • MedPage Today informs us,
    • “Use of single maintenance and reliever therapy (SMART) for moderate-to-severe asthma saved money by improving outcomes, according to a meta-analysis.
    • “While SMART is recommended by guidelines, combination inhalers aren’t FDA approved for both rescue and maintenance therapy, and thus insurance coverage has been a struggle in the U.S.
    • “Finding an economic advantage should influence payer decisions, the researchers suggested, calling for broader formulary inclusion of SMART.”
  • and
    • “All hypertensive disorders of pregnancy were tied to increased long-term cardiovascular risk, but superimposed preeclampsia carried the highest risk.
    • “All subtypes were significantly associated with higher risks of heart failure and stroke, and most were associated with higher risk of cardiovascular death.
    • “Unspecified hypertension was associated with myocardial infarction, while chronic and unspecified hypertension were both associated with atrial fibrillation.”
  • The Endocrinology Advisor lets us know that “the fit-fat index (FFI), which calculates the ratio of cardiorespiratory fitness to various adiposity measures (BMI, WHR, or WHtR), is significantly associated with lower risks for cardiovascular and all-cause mortality.”
  • Genetic Engineering and BioTechnology News points out,
    • “Evidence has been rising over the past few years that the gut microbiome can significantly influence how well cancer treatments work, especially immunotherapies. But the underlying mechanism has remained unclear. Now, a new study reveals how bacteria in the gut can help determine whether the amino acid asparagine (obtained from diet) will increase tumor growth or activate immune cells against the cancer​.
    • “The findings, published in Cell Microbe and Host in the paper, “Microbiota utilization of intestinal amino acids modulates cancer progression and anticancer immunity,” could lead to a novel cancer treatment approach and monitoring strategy; instead of targeting tumors directly, clinicians may one day be able to reshape the gut microbiome or diet to starve tumors while supercharging immune cells.
    • “Our study suggests that we need to think about how the interplay of diet, gut microbiota and tumor-infiltrating immune cells could affect cancer growth and response to therapy. We can’t overlook this key level regulation,” said Chunjun Guo, PhD, associate professor of immunology at Weill Cornell.”
  • Per BioPharma Dive,
    • “Novo Nordisk’s experimental combination shot CagriSema helped people with diabetes and obesity lower their blood sugar and lose more weight than the blockbuster drug Wegovy in a Phase 3 trial, the company said Monday, building the case for regulatory approval.
    • “The results come from one of several studies Novo has underway in obesity and diabetes for CagriSema, which adds a second metabolic drug to the active ingredient from Wegovy in a fixed-dose injection. The Denmark-based drugmaker has already asked the Food and Drug Administration to approve the shot in obesity.
    • “The data could sharpen Novo’s rivalry with Eli Lilly and its obesity drug Zepbound, which has overtaken Wegovy to become the biggest-selling obesity treatment in the world. Looking at all participants enrolled in the trial, CagriSema’s weight loss and blood-sugar reductions fall numerically short of Zepbound’s, but a head-to-head trial comparing the two hasn’t been completed yet.”
  • and
    • “An experimental rare disease drug from Sanofi succeeded against one so-called lysosomal storage disorder but failed against another, the French pharmaceutical company said Monday.
    • “According to Sanofi, the drug, dubbed venglustat, missed its primary objective in a Phase 3 study testing it against Fabry disease. However, in another study in a form of Gaucher disease, the drug met its main goal and three out of four key secondary endpoints. Sanofi didn’t provide details — they’ll be shared at medical meeting this week — but said it intends to submit the Gaucher results to global regulatory authorities.”

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

  • MedCity News reports,
    • “Access to primary care is collapsing in the U.S., creating an opening for new models that lower costs and improve outcomes.
    • “This week, Premise Health and Crossover Health moved to capitalize on that opportunity, announcing an agreement to merge into a single company focused on scaling primary care access. The combined organization will provide onsite, nearsite and virtual care for more than 400 employers with millions of members, operating nearly 900 wellness centers across the country.
    • “The new entity will be led by Premise CEO Stu Clark. He framed the deal as a convergence of two companies with the same thesis: advanced primary care is the lever to disrupt U.S. healthcare. Both companies define advanced primary care as an integrated bundle of primary care, behavioral health, pharmacy services and care navigation.
    • “Crossover and Premise have proven that a few things happen when you deploy our advanced primary care models: access goes up, health improves and costs go down. Costs go down for the employer as well as for the family,” Clark stated.
    • “The company’s target customers will be large self-insured employers, mainly Fortune 1000 companies, unions, Native tribes and government entities, he said.”
  • Healthcare Dive relates,
    • “Tenet has regained full ownership of Conifer Health Solutions, acquiring the remaining stake in its revenue cycle management business from CommonSpirit Health.
    • “CommonSpirit will pay Tenet almost $1.9 billion over the next three years to get out of its existing services contract, according to the deal announced Monday. That’s offset by $540 million that Conifer will pay CommonSpirit for its almost 24% equity stake and to eliminate CommonSpirit’s capital account.
    • “All told, Tenet executives said the deal creates almost $2.7 billion in total value to the system through the cash payments, the reduction of liability on its balance sheet and the value of the additional Conifer equity. Tenet’s stock rose 2% in morning trade Monday following the news.”
  • Fierce Healthcare informs us,
    • “Community Health Systems (CHS) has wrapped a deal to divest its 80% interest in two joint ventures to Vanderbilt University Medical Center (VUMC), the organizations announced Monday morning.
    • “The joint ventures own and operate Tennova Healthcare – Clarksville, a 270-bed hospital with 1,100 staff, and other ancillary businesses in the major Tennessee city. CHS received $623 million before certain transaction expenses for the interests, with CHS also paying $23 million of owed balances to the subsidiaries upon completion of the transaction. 
    • “VUMC, in its announcement, said it will be renaming the hospital and a freestanding emergency room to Vanderbilt Clarksville Hospital and Vanderbilt Emergency Sango, respectively. It also highlighted physician practices in Clarksville plus nearby Dover, Pleasant View and Tiny Town that were included in the deal.”
  • and
    •  “Community Health Systems (CHS) has sold its Commonwealth Health system to nonprofit Tenor Health Foundation, the for-profit chain announced.
    • “The sale, effective Feb. 1, comes just days after the parties received regulatory clearance from the state and in the wake of community and government efforts to keep the facilities open despite financial losses (see that story below). 
    • “The announcement also makes public the three-hospital system’s price tag: $33 million of cash plus a $15 million promissory note from Tenor, with additional cash considerations possible depending on collections of certain patient accounts receivable during the following 90 days.”
  • Healthcare Dive adds,
    • “Healthcare bankruptcies declined in 2025, even as the sector faces financial headwinds on the horizon, according to an analysis published last week by restructuring advisory firm Gibbins Advisors.
    • “The industry recorded 45 bankruptcy filings for debtors with liabilities of at least $10 million last year, down 21% from 2024 — and a steep drop from the 79 cases logged in 2023. However, hospital bankruptcies rose. 
    • “Another year of falling Chapter 11 bankruptcy filings doesn’t necessarily signal financial health in the sector, the report cautioned. Healthcare remains under “significant pressure” as the industry faces looming challenges like historic cuts to Medicaid, according to Gibbins.” 
  • The New York Times tells us,
    • If you wind up at an urgent care center in America, it’s increasingly likely you will be treated by a P.A. For a long time, P.A. meant the same thing everywhere: “physician assistant,” a licensed medical professional who can perform patient care, including prescribing medicine, under the supervision of a doctor.
    • But that might be changing. In Oregon, New Hampshire and Maine, P.A. now means “physician associate,” and other states may follow this year.
    • “Assistant” versus “associate” might sound like a trivial semantic debate, but to many practitioners, and to the American Academy of Physician Associates (which changed its own name in 2021), it’s an important part of the expanding role of P.A.s in health care. * * *
    • “Since 2000, the number of P.A.s has quadrupled, while many parts of the country face a shortage of doctors. That means P.A.s are becoming more numerous — and visible — in all fields of medicine, from primary care to dermatology. And along with the name change, they are seeking the ability to operate more independently from doctors.”
  • Per The Wall Street Journal,
    • “Eli Lilly plans to open a $3.5 billion weight-loss drug manufacturing plant in Pennsylvania’s Lehigh Valley, creating 850 permanent jobs.
    • “Pennsylvania is investing $100 million in tax credits and grants for the project, plus $5 million for a pharmaceutical training center.
    • “Lehigh Valley manufacturing jobs have grown by 28.8% since 2010, triple the national rate, despite recent U.S. manufacturing job contractions.”
  • Per Beckers Health IT,
    • “Oracle Health is expanding its Clinical AI Agent to help clinicians automate the creation of clinical orders during patient appointments.
    • “The tool now supports automated order creation for laboratory tests, imaging and diagnostic studies, new and refilled prescription medications, follow-up appointments and referrals. Oracle Health said in a Feb. 2 news release that the update builds on the product’s existing note-generation feature and uses ambient listening during visits to draft clinical orders for physician review and approval.
    • “The technology is designed to reduce the administrative burden of repetitive manual tasks, such as order entry, which can pull providers away from direct patient care and contribute to burnout.”

Monday report

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Patient safety, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “The Senate inched closer to triggering a partial government shutdown Monday as GOP leaders pushed forward with a $1.33 trillion funding package that includes a Homeland Security bill Democrats vowed to oppose.
    • “With only four days left before current funding for most federal agencies runs out, both parties sought to find an exit ramp from the road to a shutdown that neither side wants.”
  • The Wall Street Journal reports,
    • “The Trump administration is proposing a .09% average payment increase for Medicare Advantage plans in 2027, significantly below Wall Street’s roughly 4% to 6% expectations.
    • “The proposal also includes eliminating payments tied to diagnoses from insurer medical chart reviews not linked to specific medical visits, reducing the 2027 payment rate by 1.53 percentage points.
    • “Overall payments are projected to increase by 2.54% for 2027, combining the proposed rate changes with an additional 2.45% from underlying billing trends.”
  • Per another CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) today issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking public feedback on potential approaches to strengthen the American-made supply chain for personal protective equipment (PPE) and essential medicines. Building on lessons learned during the COVID-19 public health emergency, the agency is exploring ways to reduce reliance on foreign-made medical supplies and enhance the nation’s readiness for future emergencies while supporting American workers and manufacturers.” * * *
    • “Information on how to submit comments is available via the Federal Register at: https://www.federalregister.gov/public-inspection/current. There is a 60-day comment period.”
  • The American Hospital Association (AHA) News notes,
    • The AHA Jan. 26 urged the Health Resources and Services Administration to take immediate action to stop a new Eli Lilly and Company policy from taking effect on Feb. 1, including by “assessing civil monetary penalties for intentionally overcharging 340B hospitals.”  
    • On Jan. 15, Lilly issued a notice to all 340B covered entities that the company was updating its data requirements for its 340B distribution program. The policy would require 340B covered entities to submit claims data for all dispensations of all Lilly drugs, regardless of setting.  
    • “All told, Lilly’s draconian new policy is a case of ‘déjà vu all over again,’” the AHA wrote. “Once more, we have a drug company taking unilateral action against 340B hospitals based on flawed legal and policy reasoning, testing the limits of the law and challenging HRSA’s authority over the 340B Program. Much like its 2021 contract pharmacy restrictions and its 2024 unilateral rebate policy, Lilly seeks to boost its bottom line at the expense of 340B hospitals and the vulnerable patients they serve.” 
  • Healthcare Dive reports,
    • “Providers and health insurers submitted almost 1.2 million cases to a federal portal meant to resolve disputes over surprise medical bills in the first half of 2025 — almost 40% more than in the last six months of 2024, according to new data from the CMS.
    • “Arbiters are handling the rising volume while cutting into the existing backlog, processing more than 1.3 million disputes in the first half of the year, the CMS said. That’s up almost 50% from the prior six months.
    • “Still, despite faster closures, the independent dispute resolution process remains dogged by problems. Many submitted disputes are actually ineligible for IDR, and parsing through those is the primary cause of delays, the CMS said. And, the lion’s share of disputes continue to be submitted by a handful of mostly private equity backed-provider groups, raising concerns IDR is being exploited for profit.”
  • The AHA News adds,
    • “The Departments of Health and Human Services, Labor, and the Treasury have added Dane Street, LLC as a new independent dispute resolution entity, bringing the total number to 16. IDR arbitrators help make payment determinations in disputes between providers, group health plans and health insurance issuers under the No Surprises Act.” 
  • OPM Director Scott Kupor writes in his Secrets of OPM blog about “the performance management priorities and actions the Trump Administration is taking on behalf of the American people.”

From the Food and Drug Administration front,

  • Fierce Healthcare relates,
    • “Aidoc has secured 11 new indications from the Food and Drug Administration (FDA), bringing a comprehensive body CT triage solution to emergency departments and ambulatory settings to reduce patient backlogs. 
    • “Aidoc, a clinical artificial intelligence company, is trying to solve the root issue of overcrowding in emergency departments and provider offices. The company argues that providers’ operational workflows, which mostly prioritize patients on a “first come, first serve” basis, don’t work well.
    • “Instead of first-in, first-out, Aidoc’s AI triage solution can prioritize scans based on its initial review of the images. Those scans are then moved up in the queue for radiologists to review, allowing acutely ill patients to receive care more quickly.”
  • MedTech Dive points out,
    • “Intuitive Surgical on Monday provided more details about its new cardiac surgery initiative for the da Vinci 5 robot, including specifying nine procedures that received U.S. clearance.
    • “Among those are mitral and tricuspid valve repair, mitral valve replacement, and left atrial appendage closure — procedures that comprise key businesses for heart device companies such as Boston Scientific, Abbott and Edwards Lifesciences.
    • “Intuitive said cardiac procedures with da Vinci 5 can enable surgeons to operate through small incisions without splitting the breastbone, which is typically required in open heart surgery.” * * *
    • “The update comes after Intuitive executives told analysts on an earnings call last week that the Food and Drug Administration had cleared the robot for cardiac surgery.”
    • “Intuitive said it plans to begin working with a limited number of U.S. sites through 2026 to establish da Vinci 5 cardiac programs.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The American Academy of Pediatrics recommends children be vaccinated against 18 diseases, more than the U.S. government directs after it overhauled its schedule.
    • “The doctors group, which released its recommendations Monday, kept its guidance largely unchanged from its previous version from last year. The group said it doesn’t endorse the Centers for Disease Control and Prevention’s childhood-vaccine schedule. The agency now recommends all children get vaccinated against 11 diseases.”
  • A commentator, writing in STAT News, observes,
    • “The recent overhaul of the U.S. pediatric vaccine schedule under Health and Human Services Secretary Robert F. Kennedy Jr. touched off a firestorm of criticism — most of it for demoting six vaccines from routinely recommended to “shared clinical decision-making” (SCDM). The implication was that these six vaccines are optional, less safe, or less useful than the routinely recommended ones.
    • “Like nearly everyone in public health, I agree that the evidence for the safety and efficacy of the six vaccines is robust and hasn’t changed.
    • “But in its urge to say what Kennedy gets wrong, the public health and medical community is actively resisting something he gets right: Vaccination decisions belong to patients and their parents, guided by candid advice from health care professionals.”
  • The American Medical Association lets us know what doctors wish their patients knew about polio.
  • The New York Times relates,
    • “For years, the nonprofit groups that coordinate transplants in the United States regularly ignored federal rules — skipping patients at the top of waiting lists and sending organs to those who weren’t as sick and hadn’t waited as long.
    • “But new federal data shows that the rate of skipped patients has dropped by more than half in recent months, a change that reflects a far-reaching effort to make the transplant system fairer and safer.
    • “This is truly great news for patients and the system,” said Dr. Jesse Roach of the National Kidney Foundation. “We need to continue to monitor it, to ensure the system is fair, efficient and transparent. But this is a win.”
  • Beckers Clinical Leadership informs us,
    • “The Joint Commission and the National Quality Forum are aligning their serious safety event reporting frameworks in an effort to reduce redundancy and ease the administrative burden on healthcare providers.
    • “Effective Jan. 1, 2027, The Joint Commission will adopt the NQF’s Serious Reportable Events, or SRE List, across all accredited domestic and international organizations, according to a Jan. 26 news release from the organizations. Three workplace safety events — homicide, sexual abuse or assault, and physical assault of staff — will be retained as part of the revised SRE list.
    • “Leaders of both organizations said consolidating around the NQF list will simplify reporting for clinicians and hospitals while providing a more consistent, standardized framework for measuring and tracking patient safety events across states and health systems.”
  • Genetic Engineering and BioTechnology News notes,
    • “It is known that inflammatory bowel disease (IBD) increases the risk of colorectal cancer (CRC). But the underlying mechanism—and the genetic drivers—between this link remain yet to be determined. Genetic variants in TNFSF15, encoding tumor necrosis factor (TNF)-like cytokine 1A (TL1A), are associated with both severe IBD and advanced CRC.
    • “Now, a new study points to immune reactions in the gut—driven by a key signaling protein and a surge of white blood cells from the bone marrow—to help explain why people with inflammatory bowel disease have a higher risk of colorectal cancer.
    • “This work is published in Immunity in the paper, “Innate lymphoid cells activated by the cytokine TL1A link colitis to emergency granulopoiesis and the recruitment of tumor-promoting neutrophils.”
  • Per Healio,
    • “Researchers compared the outcomes of more than 40,000 infants who were immunized through nirsevimab or maternal RSV vaccination.
    • “Nirsevimab was associated with fewer severe outcomes than the maternal vaccine.” * * *
    • “Our results should not be interpreted as evidence against maternal RSV vaccination,” Marie Joelle Jabagi, PharmD, PhD, MPH, said. “Instead, they underscore that clinicians should individualize prevention strategies based on clinical context, access to care and timing within the RSV season. Both approaches remain valuable and may be complementary, particularly in efforts to maximize population-level protection against RSV.”
  • Per Health Day,
    • “Childhood ADHD can set a person up to have poor health in middle age, a new study says.
    • “People with ADHD traits at age 10 are likely to have chronic illness and disability at age 46, researchers reported Jan. 21 in JAMA Network Open.
    • ‘The study said these health problems can include asthma, migraines, back problems, cancer, epilepsy, hearing problems, GI disorders, kidney disease and diabetes.
    • “We have added to the concerning evidence base that people with ADHD are more likely to experience worse health than average across their lifespan,” said lead researcher Joshua Stott, a professor of aging and clinical psychology at University College London in the U.K.
    • “People with ADHD can thrive with the right support, but this is often lacking, both due to a shortage of tailored support services but also because ADHD remains underdiagnosed, particularly in people in midlife and older, with needs unaddressed,” Stott said in a news release.”

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

  • The Street reports
    • “The Centers for Medicare & Medicaid Services (CMS) recently published some in-the-weeds datasets on the use of, and spending for, drugs prescribed to Medicare beneficiaries. 
    • “There’s the Medicare Quarterly Part B and Part D Drug Spending Datasets and the annual version of the Medicare Part B and Part D Drug Spending datasets.”
    • The Street feature a 13 minute webinar with a consultant who has used the data sets (plus a transcript of that webinar).
  • Beckers Hospital Review tells us,
    • “More than 500,000 providers prescribed GLP-1s in 2025, with wide variation between specialties, according to a Jan. 22 article from IQVIA, a clinical research firm. 
    • “GLP-1 medications are approved for several conditions, including Type 2 diabetes, obesity, cardiovascular disease, chronic kidney disease, liver disease and sleep apnea. Among GLP-1 drugs approved for weight loss — Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound — adoption and prescribing trends differed across provider specialties.
    • “Endocrinologists stand out as both quick adopters of Wegovy and subsequent high writers for Zepbound, leveraging their expertise in managing complex metabolic conditions to integrate new treatments earlier,” according to IQVIA. “Their readiness to prescribe is shaped by familiarity with the mechanisms of GLP-1 therapies and a patient base that often presents with comorbidities where these drugs deliver added value.”
    • “Primary care providers account for the largest share of GLP-1 prescriptions due their broad patient base. However, in contrast to endocrinologists, they have been slower to adopt GLP-1s, which IQVIA defines as prescribing a GLP-1 within the first 1.75 years of the drug entering the market.”
  • Per BioPharma Dive,
    • “Children with Duchenne muscular dystrophy who received Sarepta Therapeutics’ gene therapy Elevidys in a clinical trial continued to perform better on tests of motor function than historical data suggests they should, and the benefits appear to compound with time, the company said Monday.
    • “According to Sarepta, patients in the study, Embark, had greater reductions on three measures of function than a matched historical control group, with the gap “significantly widening” between two and three years after treatment. Doug Ingram, Sarepta’s CEO, said the data is an opportunity to “rebalance the discussion” surrounding Elevidys, sales of which have slowed amid safety concerns and newly restrictive labeling. 
    • “In research notes published Monday, multiple Wall Street analysts viewed the data as a positive development for the company. They also noted, though, that investors will be more focused on whether the results translate to sales growth. Sarepta shares, which have lost much of their value over the last year, rose by double digits in morning trading.” 
  • MedCity News considers “what does OpenAI and Anthropic’s healthcare push mean for the industry?”
    • “As OpenAI and Anthropic move deeper into healthcare, experts say AI chatbots are becoming the new front door to medicine. This shift is shaking things up for some health tech startups, redefining the patient-provider relationship, and intensifying debates over safety, privacy and accountability.:

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the J.P. Morgan Healthcare Conference,

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

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

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

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.”

Monday Report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

In notable death news,

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

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC

  • The American Hospital Association News reports,
    • “President Trump Dec. 1 signed the AHA-supported SUPPORT Act (H.R. 2483) into law. The legislation reauthorizes key prevention, treatment and recovery programs for patients with substance use disorder. It also includes programs to support the behavioral health workforce.”
  • and
    • “The House Dec. 1 passed the Hospital Inpatient Services Modernization Act (H.R. 4313), legislation extending certain Medicare waivers authorizing the hospital-at-home care program for five years. The AHA expressed support for the bill in September.” 
  • The House Oversight and Government Reform Commitee posted a wrap-up concerning the mark-up session held today and mentioned in yesterday’s FEHBlog.
  • Fierce Healthcare tells us,
    • “Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy, M.D., is doubling down on his scrutiny of the American Medical Association’s (AMA’s) handling of billing and claims processing codes, telling the professional organization this week that it dodged several of the questions he posed on pricing and other topics back in October.
    • “The senator, a Republican from Louisiana and Congress’ most prominent healthcare legislator, has been putting the screws on the professional association for, in his words, “abusing” its widely adopted Current Procedural Terminology (CPT) coding system with “exorbitant fees” that drive higher healthcare costs.” 
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services Dec. 2 repealed the minimum staffing requirements for nursing homes that participate in Medicare and Medicaid that the agency adopted in 2024. Specifically, CMS is removing the requirements for nursing homes to provide a minimum of 3.48 hours of nursing care per resident day, including 0.55 hours of care from a registered nurse per resident day and at least 2.45 hours of care from a nurse aide per resident day. The agency is also removing the requirement for nursing homes to have 24/7 onsite RN services and is reinstating its prior policy requiring facilities to use the services of an RN for at least eight consecutive hours a day, seven days a week and to designate an RN to serve as the director of nursing on a full-time basis except when waived. The facility assessment requirements adopted in the 2024 final rule will remain in place. CMS’ actions are consistent with the budget reconciliation bill enacted in July, which imposed a 10-year implementation and enforcement moratorium on the minimum staffing requirements for long-term care facilities.”
  • Fierce Healthcare points out,
    • “As vaccine policy uncertainty reaches a new level in the U.S., the Centers for Disease Control and Prevention’s (CDC’s) team of vaccine advisors is set to deliberate later this week on childhood immunizations under a new chairman. 
    • “The Advisory Committee on Immunization Practices (ACIP), which was overhauled and repopulated by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. over the summer, is set to meet Dec. 4 and Dec. 5. 
    • “On the agenda (PDF) is a vote on hepatitis B vaccines plus discussions on “vaccine safety” and “the childhood and adolescent immunization schedule,” according to a Federal Register notice.” * * *
    • “Stepping up the plate as chairman of the ACIP is Kirk Milhoan, M.D., Ph.D., a pediatric cardiologist and former U.S. Air Force flight surgeon. Milhoan, one of five new ACIP panelists added to the roster in September, is a senior fellow with the Independent Medical Alliance (IMA) who specializes in treating patients with long COVID and “vaccine-related cardiovascular toxicity,” according to his IMA bio.”

From the Food and Drug Administration front,

  • Fierce BioTech reports,
    • “Mere weeks after being named the nation’s top drug regulator, Richard Pazdur, M.D., is taking steps to retire as head of the FDA’s Center for Drug Evaluation and Research, an FDA spokesperson confirmed to Fierce Biotech.
    • “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” the spokesperson said. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.”
    • “Pazdur has filed papers to retire at the end of this month and informed FDA colleagues of his decision at a Tuesday meeting, according to a report from Stat News.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at roughly $1 million—from three firms in Missouri.
    • “The seizure focused on foods and dietary supplement products—including liquid shots and tablets—containing concentrated 7-OH as an added ingredient. Concentrated 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. It cannot be lawfully added to dietary supplements or conventional foods. These products are considered adulterated because 7-OH does not meet applicable safety standards. Also, the FDA has not approved 7-OH for medical use.
    • “This enforcement action is a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We must be proactive and vigilant to address emerging threats to our communities and our kids.”
  • Per MedTech Dive,
    • “BD has written to users of its Alaris pump modules about a risk associated with two complaints of serious injury.
    • “The Food and Drug Administration, which shared details of the letter Friday, has categorized the correction as a Class I recall because of the potential for serious injury or death.
    • “BD paid a $175 million civil penalty last year to settle charges that it misled investors about problems with its Alaris infusion devices and in September recalled pumps with variable performance.” 
  • and
    • “Cleveland Diagnostics said Monday it received Food and Drug Administration approval for a test that analyzes the structure of protein biomarkers in the blood for prostate cancer signals, to aid in determining whether a biopsy is needed.
    • “The IsoPSA technology is for men aged 50 and older whose results from a traditional prostate-specific antigen blood screening showed elevated PSA levels.
    • “Elevated PSA levels can be a sign of prostate cancer, but may be caused by other conditions. The IsoPSA test can help clarify whether a patient with an elevated PSA should have a biopsy procedure or can extend the interval between biopsies, Cleveland Diagnostics Chief Commercial Officer Bob Rochelle said in an interview.”

From the judicial front,

  • Thompson Reuters notes,
    • “The Ninth Circuit has vacated a trial court’s ruling that an insurer acting as a third-party claims administrator (TPA) for self-insured health plans violated Affordable Care Act (ACA) Section 1557 when it administered discriminatory plan exclusions of coverage for gender-affirming care.” * * *
    • “On appeal, the Ninth Circuit ruled that the trial court correctly concluded that the TPA’s provision of health insurance is a health program or activity, part of which is receiving federal financial assistance, and that TPAs can be liable for violating Section 1557 even when implementing plan terms drafted by a plan sponsor. However, the Ninth Circuit ordered the trial court to reconsider its ruling that the gender-affirming care exclusions were discriminatory in light of the U.S. Supreme Court’s Skrmetti decision. (Skrmetti upheld a state’s ban on gender- affirming care for transgender teenagers, reasoning that the ban did not draw classifications based on sex— rather, it prohibited such treatments for certain medical uses with respect to all minors, regardless of sex or gender.) Although the trial court’s reasoning was undercut by Skrmetti, the Ninth Circuit noted that there may be factual distinctions in this case that distinguish it from Skrmetti, such as whether an individual was denied care for a diagnosis other than gender dysphoria or whether discrimination based on a gender dysphoria diagnosis is a pretext for “invidious discrimination” based on transgender status.”
  • The New York Times updates us about New York State’s prosecution of Luigi Mangione who is accused of murdering a United Healthcare executive last December.
    • “Prosecutors have said that Mr. Mangione had personal writings with him at the time in which he denounced America’s for-profit health care system and the “parasites” of the insurance industry. The police also found a journal by Mr. Mangione in his possession that described plans for an assassination, prosecutors said.
    • “Mr. Mangione’s lawyers have argued that the police violated his constitutional rights and so physical evidence taken from his backpack and statements he made at the time should be excluded.
    • “The hearings, which began Monday and are expected to last several days, are the first time Mr. Mangione has appeared in Manhattan state court since the judge overseeing the case, Gregory Carro, threw out terrorism charges against him in September. He still faces second-degree murder and other charges, and if convicted, he could receive a sentence of 25 years to life. Mr. Mangione also faces a federal prosecution.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Abdominal obesity—the phenomenon commonly known as “beer belly”—is associated with significant cardiovascular risks, according to new data being presented at RSNA 2025 in Chicago.
    • “Abdominal obesity, a high waist-to-hip ratio (WHR), is associated with more concerning cardiac remodeling patterns than high body mass index (BMI) alone,” lead author Jennifer Erley, MD, a radiology resident at University Medical Center Hamburg-Eppendorf in Germany, said in an RSNA statement. “It appears to lead to a potentially pathological form of cardiac remodeling, concentric hypertrophy, where the heart muscle thickens but the overall size of the heart doesn’t increase, leading to smaller cardiac volumes. In fact, the inner chambers become smaller, so the heart holds and pumps less blood. This pattern impairs the heart’s ability to relax properly, which eventually can lead to heart failure.”
  • Health Day relates,
    • “People with severe asthma often take daily steroid medications to help prevent attacks, yet the drugs can bring about serious side effects. Is there another way?
    • “In a new trial, researchers examined how much an add-on treatment, already approved in the United States and United Kingdom, for severe asthma helped people with their symptoms and need for steroid pills.
    • “They found that an injected antibody called tezepelumab allowed 90% of people with severe asthma to reduce their use of daily steroids — and half of patients who received the injection were able to stop taking steroid pills altogether.
    • “Two-thirds of participants in the year-long trial also saw their asthma attacks disappear.
    • “This is an incredibly encouraging development for the future of asthma care that could transform the lives of people with severe asthma,” said Samantha Walker, who directs research at Asthma + Lung UK, a nonprofit advocacy group for people with asthma.”
  • and
    • “Tea, coffee, berries, cocoa, nuts, whole grains, olive oil: They’re all rich in antioxidant compounds called polyphenols, and they’re all good for your heart, a new British study shows.
    • “This research provides strong evidence that regularly including polyphenol-rich foods in your diet is a simple and effective way to support heart health,” said study lead author Yong Li, a PhD candidate in nutrition at Kings College London.
    • “As her team explained, polyphenols are natural compounds that have long been known to be beneficial for heart, brain and gut health.”
  • Per MedPage Today,
    • “A phase III trial of investigational valiltramiprosate (ALZ-801) did not meet its primary endpoint in people with early symptomatic Alzheimer’s disease, but the drug did show benefits in a prespecified population with mild cognitive impairment who carried two copies of APOE4.“
  • and
    • “An mRNA influenza vaccine was approximately 35% more effective than an inactivated quadrivalent flu vaccine against two different strains, based on new data from a phase 3 randomized trial.” * * *
    • “The new data provide compelling evidence that the mRNA platform may protect against influenza, which could be meaningful for future use for both seasonal and pandemic influenza, if warranted, [Kelly] Lindert [M.D., a Pfizer employee] said.
    • “The investigators have identified areas to refine the mRNA influenza vaccine, and they are working to evaluate these candidates in ongoing studies, Lindert told Medscape Medical News. “Our long-term goal is to develop an influenza vaccine that is broadly protective against influenza A and B strains, including protection against severe influenza in children through elderly adults,” she said.”

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

  • McKinsey and Co. explains why “US healthcare organizations should rethink care and business models in response to substantial economic pressures and evolving care demands.”
    • “To address these cost and acuity challenges, healthcare stakeholders should continue to pursue innovative, outcome-focused care models that balance cost and care quality. Four archetypes of outcome-focused care models are in practice today. While these models have demonstrated promise, none have fully realized their potential. In this article, we delve into the value-creating opportunities within the four models:
      • “episodic models focused on shifting sites of care
      • “payer-led models focused on utilization, benefit, and care management
      • “primary care provider (PCP)–led models focused on risk-bearing, value-based care (VBC)
      • “specialty-led models focused on complex disease conditions.”
  • Adam Fein, writing in his Drug Channels blog, opines,
    • “Contrary to popular belief, the Inflation Reduction Act’s (IRA) maximum fair prices (MFPs) could temporarily boost profits for retail pharmacies serving Medicare Part D patients. 
    • “The bad news? The IRA is also one of the five key forces deflating the gross-to-net bubble. 
    • “That’s why any IRA-related pharmacy profits will vanish if manufacturers lower list prices to be closer to net prices. At least 13 brand-name drugs—five of which have MFPs—reportedly plan to reduce list prices within the next two months.
    • “[R]etail pharmacies risk becoming collateral damage from significant deflation in the gross-to-net bubble for drugs subject to an MFP. Welcome to our bonkers healthcare system—where everyone wants lower prices, until they actually get them. 
    • “What’s more, list price cuts will reduce profits from 340B contract pharmacy operations, while weakening covered entities’ main objections to a 340B rebate model. Get ready for a 340B slowdown.”
  • MedCity News considers that “The healthcare industry is contending with a difficult question: how to properly wield AI without taking on too much risk? Inherent in this battle is the role of humans. Here’s how Merck’s chief data officer is viewing AI.” It’s an interesting interview.
  • Healthcare Dive reports,
    • “The share of family physicians working in rural areas decreased 11% from 2017 to 2023, according to a study published this month in the Annals of Family Medicine.
    • “The Northeast saw the greatest loss in rural family physicians over the study period at 15.3%, while the West lost just 3.2% of rural family doctors.
    • ‘The data adds to concerns about physician shortages nationwide. America is expected to need more doctors than ever by 2030 to care for aging Baby Boomers, yet physicians say they’re struggling to hire and retain qualified talent amid high levels of burnout.” 
  • Per Beckers Hospital Review,
    • “Franklin, Tenn.-based Community Health Systems has completed the sale of select ambulatory outreach laboratory assets to Labcorp for $194 million in cash.
    • “The deal includes certain assets of CHS-affiliated hospitals’ lab services in 13 states, such as patient service centers and in-office phlebotomy locations. CHS will retain and continue operating its inpatient and emergency department laboratories, including lab services for hospital-based care like imaging and pre-admission testing.
    • “Completing this transaction with Labcorp allows our health systems to focus on core services and improve the overall patient experience, aligning with our unwavering commitment to providing high-quality, accessible healthcare to our communities,” CHS President and Interim CEO Kevin Hammons said in a Dec. 2 news release. “Labcorp’s scale and investment in technology supports its ability to efficiently deliver outreach laboratory services to patients and healthcare consumers.”

Monday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC

  • Per a November 28, 2025, Congressional news release,
    • “Today, House Committee on Oversight and Government Reform Chairman James Comer (R-Ky.) announced a markup will take place on Tuesday, December 2 at 10:00am ET to consider a series of legislation to reform procedures in the federal workforce, to promote greater transparency, and bring accountability to federal agencies and the District of Columbia.
    • “The American people deserve a productive federal government that provides transparency and accountability across all agencies, processes, and procedures. The House Oversight Committee is dedicated to ensuring that Americans’ voices are not diluted and that they can be employed in the federal workforce without undue burdens and other hinderances. Working in tandem with President Trump’s mission to reform the federal government, the Committee will do its part to examine the efficiency of agencies’ operations and remove any barriers that prevent Americans from fully participating in them,” said Chairman Comer.” * * *
    • “The markup will be open and available to the public and press and will be livestreamed online at https://oversight.house.gov/.”
  • Beckers Health IT tells us,
    • “A bipartisan group of federal lawmakers has introduced a bill they say would extend the availability of healthcare AI to rural Americans and seniors.
    • “The Health Tech Investment Act would assign all FDA-approved AI-enabled devices a temporary payment classification for a minimum of five years, pending the sufficient collection of cost data and the issuance of a permanent CMS payment code.”
  • Bloomberg News informs us,
    • “The US Office of Personnel Management is ending a program that gives federal workers discounted college tuition. 
    • “OPM Director Scott Kupor said in a memo Monday that the office would cancel the Federal Academic Alliance at the end of the current academic term. The voluntary partnership between universities and the federal government offered special rates for government employees and their families.
    • “Kupor wrote that the program is outdated and rarely used, with less than 0.2% of the federal workforce participating. More agencies are offering their own training programs, he said.”
  • Politico adds,
    • “The Trump administration wants federal agencies to shuffle top civil servants to more effectively implement the president’s agenda.
    • “The head of the Office of Personnel Management on Monday issued guidance encouraging agency leaders to review their rosters of top civil servants known as the Senior Executive Service and to consider reassigning them to new posts.
    • “The guidance marks the Trump administration’s latest move to overhaul the federal workforce and its senior management. The administration says the move will help dislodge “entrenched” civil servants, but critics accuse the administration of exerting undue political influence over federal workers.”
  • The Congressional Research Service released a report offering its analysis of No Surprises Act Independent Dispute Resolution data for 2024.
    • “The year 2024 marks the first year in which the IDR process was operational throughout the year without suspension, since it first began accepting dispute submissions in April 2022. This report, building on a prior CRS report analyzing 2023 data on IDR operations, reviews and analyzes data made publicly available by the Departments of Health and Human Services, Labor, and the Treasury—pursuant to NSA requirements—regarding IDR operations in calendar year 2024. In general, the data show an IDR process that was still maturing in 2024, as the year saw significant increases in the use of the IDR process (relative to 2022 and 2023) by providers; a large increase in the number of determinations made relative to 2023 and improvements in the amount of OON emergency/nonemergency service dispute determinations made within the generally required 33 business days (though a majority of determinations were still made outside of that window); and continued notable increases in payment determination amounts in certain medical specialties.”
  • Per the American Hospital Association News,
    • “The Centers for Medicare & Medicaid Services Innovation Center will launch a new, outcome-aligned payment model for providers offering technology-supported care to individuals with Original Medicare for managing common chronic conditions. The Advancing Chronic Care with Effective, Scalable Solutions Model will focus on conditions such as high blood pressure, diabetes, musculoskeletal pain and depression. CMS said it will pay participants in fixed installments for managing patients’ qualifying conditions, with full payment tied to achieving measurable health outcomes. CMS will begin accepting applications for the 10-year voluntary model Jan. 12, 2026, with an initial deadline of April 1, 2026. The model will begin July 1, 2026.”
  • and
    • “The Centers for Medicare & Medicaid Services announced Dec. 1 that it intends to expand the Inpatient Rehabilitation Facility Review Choice Demonstration to include IRFs in Texas and California. The demonstration, which is currently active for IRFs in Alabama and Pennsylvania, subjects all Original Medicare IRF claims to either pre-claim or post-payment review. IRFs in Texas will need to select either pre-claim or post-payment review by Feb. 13, 2026, and the demonstration will begin March 2, 2026. IRFs in California will need to select pre-claim or post-payment review by April 14, 2026, and the demonstration will begin on May 1, 2026. The AHA has opposed this demonstration, indicating its unnecessarily burdensome nature, and will continue to encourage the agency to pause its expansion.” 
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Martin Kulldorff, Ph.D., as chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE).  Kulldorff recently chaired the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) and previously taught at Harvard Medical School. He is a biostatistician and epidemiologist with more than 200 peer-reviewed publications.
    • “ASPE serves as HHS’ in-house think tank, providing policy advice to the Secretary. It also leads special initiatives, coordinates departmentwide research and evaluation activities, manages major planning processes, and produces analyses and cost estimates for policy options across public health, health care, and human services.”
  • The Wall Street Journal reports,
    • “The U.K. will increase the net price paid for new patented medicines by 25% to avoid U.S. tariffs on pharmaceutical exports.
    • “The U.K. government will reduce the clawback tax on high-value drugs to 15% next year, down from as much as a quarter or more.
    • “The U.S. guaranteed zero tariffs for U.K. pharmaceutical exports for at least three years as part of the agreement.”
  • Bloomberg Law adds,
    • “A deal between President Donald Trump and Novo Nordisk A/S to slash Ozempic and Wegovy prices under a most-favored-nation plan will override the costs for the blockbuster drugs negotiated separately by the Medicare agency.
    • “Due to the terms and timelines of the negotiated deals, the MFN prices for covered GLP-1 drugs are expected to supersede the IRA prices,” a spokesperson for the Centers for Medicare & Medicaid Services said in an email Friday.” * * *
    • “The prices under the most-favored-nation plan are scheduled to launch in 2026, while the negotiated drug prices for the second were slated to run in 2027.”
  • Fierce Pharma further adds,
    • “On the heels of striking a deal with the Trump administration to reduce the prices of several of its most popular drugs for U.S. patients, Eli Lilly has unveiled additional savings for cash-paying users of its obesity and sleep apnea med Zepbound.
    • “In the early November announcement of its agreement with the government, Lilly pledged to reduce the self-pay price of Zepbound in multidose pen form—which has yet to be approved by the FDA. Once the approval is secured, the multidose pens will be available via the LillyDirect online pharmacy platform for $299 to $449.
    • “Monday’s announcement adds discounts to single-dose vials of Zepbound, which are already approved and available in the U.S. Self-paying patients prescribed the GLP-1 will now be able to access the vials at $50 to $150 off their previous prices on LillyDirect.”
  • Per Politico,
    • “Three blockbuster drugs will exit Medicare’s price negotiation program in 2027 after regulators determined they now face generic or biosimilar competition, according to a Centers for Medicare and Medicaid Services memo obtained by POLITICO.
    • “The removal means that Novartis’ chronic heart failure treatment Entresto, Janssen’s anti-inflammatory medicine Stelara, and Bayer and Janssen’s blood clotting drug Xarelto will no longer be subject to the negotiated price reached during the first cycle of Medicare drug price talks.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees. Agentic AI capabilities will enable the creation of more complex AI workflows — harnessing various AI models — to assist with multi-step tasks.
    • “Agentic AI refers to advanced artificial intelligence systems designed to achieve specific goals by planning, reasoning, and executing multi-step actions. These systems incorporate built-in guidelines — including human oversight —to ensure reliable outcomes. The tool is entirely optional for FDA staff and is used voluntarily.  
    • “We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators,” said FDA Commissioner Marty Makary, M.D., M.P.H. “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.”
  • Beckers Hospital Review relates,
    • “Merck’s investigational antibody MK-2214 has received fast-track designation from the FDA for the treatment of Alzheimer’s disease.
    • “MK-2214 targets phosphorylated serine 413 tau (pS413), a marker of abnormal protein accumulation in the brain, according to a Dec. 1 news release from the company. The designation was announced alongside the first-in-human phase 1 trial data to be presented at the Dec. 1-4 Clinical Trials on Alzheimer’s Disease 2025 event in San Diego. The data supported dose selection for an ongoing phase 2 trial.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through internal testing. The devices are being permanently recalled and the FDA advised customers to stop using the product. The FDA said unauthorized individuals could potentially change device therapy settings or access device data if it is left unattended, which could lead to the life-supporting air delivery function not working as intended.   
    • “In addition, the FDA identified Class I recalls of Becton Dickinson Alaris Pump Modules and Balt USA Mega Ballast Distal Access Platforms.”  

From the judicial front,

  • The American Hospital Association New points out,
    • “The AHA, the Maine Hospital Association and four safety-net health systems from across the country Dec. 1 filed a lawsuit in the U.S. District Court for the District of Maine to challenge the 340B Rebate Model Pilot Program. The AHA and its co-plaintiffs are seeking a temporary restraining order to stop the rebate program from going into effect Jan. 1, 2026.
    • “If implemented, the program would impose overwhelming financial and administrative burdens on 340B hospitals, many of which already operate on razor thin margins while playing a vital role in their communities, often serving as the only source of care. The lawsuit alleges that the Department of Health and Human Services’ decision to move forward with the rebate program through a rushed, opaque process violates the most basic principles of administrative law, including by ignoring the concerns of over 1,000 340B hospitals and other stakeholders, many of which highlighted the significant costs and community impact of administering the rebate model.”

From the public health and medical / Rx research front,

  • Genetic Engineering and Biotechnology News reminds us,
    • “World AIDS Day, first observed on December 1, 1988, is an international day to raise awareness of the global HIV/AIDS pandemic. Since its inception, the website notes, communities have stood together to show strength and solidarity against HIV stigma and to remember lives lost. 
    • “As of 2024, over 40 million people in the world are diagnosed with human immunodeficiency virus (HIV)—a chronic, life-threatening infection that remains one of the leading global causes of death. Today, we take a moment to reflect on the progress made in the global fight against HIV, while recognizing the challenges that remain.”
  • The Washington Post reports,
    • “A small, highly anticipated study shows a glimmer of hope in the long effort to control HIV without medication and search for a cure for a virus that attacks immune cells.
    • “Researchers gave 10 people with HIV a complex regimen of experimental immunotherapies, then discontinued the daily pills that kept the virus at bay. In six participants, the virus rebounded slowly and stayed at a low level for months, and one person’s immune system kept the virus in check for more than a year and a half — giving scientists hope that they could optimize the approach to create a cure.
    • “It’s provocative, but I’ve been doing treatment interruption studies for 30 years, and this is unexpected and unparalleled,” said Steven Deeks, a professor of medicine at the University of California at San Francisco and one of the leaders of the study. He and other scientists were quick to caution that this is a promising step forward, not a solution. The small study did not include a control group, so more studies will be needed to confirm and flesh out the exciting signal.”
  • Healio tells us,
    • “From 2008 to 2023, there has been a significant decrease in cystic fibrosis mortality rates and a significant rise in sickle cell disease mortality rates in the U.S., according to findings published in JAMA Pediatrics.
    • “For frontline clinicians, these results are a call to action,” Nansi S. Boghossian, PhD, associate professor in the Arnold School of Public Health at the University of South Carolina, told Healio. “They highlight the barriers many patients with sickle cell disease face including limited access to proven therapies, under-resourced systems and the high costs of newer treatments.”
  • NBC News explains why “Doctors seek to understand why quitting antidepressants causes withdrawal for some. A “deprescribing” movement is building up in the psychiatry field, aimed at helping patients reduce or stop their medications when no longer considered necessary.”
  • MedPage Today informs us,
    • “Changes in driving frequency, complexity, and spatial range were associated with mild cognitive impairment in older adults.
    • “Trip distances, speeding, and destination variability distinguished mild impairment from normal cognition with strong predictive accuracy.
    • “Continuous, real-world driving data may signal impairment before safety events occur, researchers suggested.”
  • The American Medical Association lets us know what doctors wish their patients knew about end of life care planning.
  • Per Health Day,
    • “About half of people who die by suicide show no prior warning signs.
    • “Many do not have mental health diagnoses or genetic psychiatric risks.
    • “Researchers hope to improve how doctors screen for suicide risk.”
  • Per BioPharma Dive,
    • “An experimental drug from Belite Bio succeeded in a Phase 3 trial in the most common form of Stargardt disease, positioning the company to seek regulatory approval next year of what could be the first marketed medicine for the condition.
    • “According to Belite, treatment with its drug, known as tinlarebant, was associated with a roughly 36% reduction in the growth rate of retinal lesions compared to a placebo over the course of two years, meeting the trial’s main goal. Both study groups had a minimal overall change in visual acuity, but Belite said that finding was “consistent” with historical data.
    • “Belite said tinlarebant was “well tolerated,” with only four patients stopping treatment due to adverse events. The most common eye side effects related to treatment were a type of color vision deficiency and issues seeing at night or adjusting to a dark environment. The majority of those cases were mild, and most resolved during the trial, the company said.”

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

  • Fierce Healthcare identifies its ten Women of Influence for 2025. Congrats to these ladies.
  • Fierce Healthcare adds,
    • “As healthcare providers increasingly adopt artificial intelligence tools, researchers, physicians and health tech companies are moving quickly to assess the verifiable impact of these technologies.
    • “Early studies looking at the use of AI tools, such as ambient scribes, among physicians are showing promising results. The use of AI scribes leads to lower burnout and lighter cognitive load for users, plus measurable cuts in documentation time, according to recent studies.
    • “Primary care doctors are also reporting that AI features embedded in the electronic health record (EHR) are helping them provide higher-quality care, according to a new survey from Elation Health.”
  • STAT News adds,
    • “The biggest radiology practice in the United States is leaning even further into artificial intelligence. The tech arm of Nashville-based Radiology Partners, which includes more than 4,000 radiologists reading more than 55 million images every year, last month acquired a new AI company for $80 million: Cognita Imaging, a Stanford researcher-founded startup that’s hoping to win the race to capitalize on foundation models in radiology.
    • “By training vision-language models on large numbers of radiological images and their written radiology reports, the hope is that AI will be able to read an X-ray or CT scan like a radiologist would: Not just by looking for a single, predetermined abnormality, but for any finding that looks important. Many existing and new radiology companies have launched themselves at that goal, despite concerns about whether such broadly-targeted technology can be validated and used safely.”
  • Beckers Health IT notes that
    • “Hospital-at-home treatment could be one way to “solve the rural healthcare crisis,” researchers from Somerville, Mass.-based Mass General Brigham say.”
  • and
    • “EHR vendors have expanded their patient-record sharing capabilities in recent years, but clinicians still report little improvement in how usable that data is, a Dec. 1 report from KLAS Research found.
    • “The report examines provider-to-provider record exchange, third-party application integration and payer-provider data sharing.”
  • Beckers Hospital Review tells us,
    • “Estes Park (Colo.) Health officially joined Aurora, Colo.-based UCHealth Dec. 1 as UCHealth Estes Valley Medical Center.
    • “This not only gives us financial stability and additional access to resources and subject matter experts, but also assistance in recruiting and retaining staff and providers, and importantly, continued access to healthcare for our patients,” Vern Carda, president of Estes Valley Medical Center, said in a news release.” 
  • BioPharma Dive informs us,
    • “Regeneron Pharmaceuticals is putting more money into gene editing, announcing Monday a partnership with Tessera Therapeutics to develop an experimental program for a rare liver and lung disease. 
    • “At the center of the deal is a treatment Tessera, a well-funded startup backed by Flagship Pioneering, is developing for alpha-1 antitrypsin deficiency. Regeneron is paying Tessera $150 million upfront, in the form of cash and an equity investment, to collaborate on the program and split future development costs and profits. Tessera could receive another $125 million in unspecified near and mid-term development milestone payments.   
    • “Tessera will lead the initial first-in-human trial, with Regeneron taking the reins for future development and eventually commercialization.”