Tuesday report

Congress

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, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The Hill reports,
    • “Lawmakers return to Capitol Hill this week facing an uphill climb to fund the Department of Homeland Security (DHS) as Republicans see an opening after President Trump’s State of the Union address on Tuesday despite few signs that Democrats are willing to compromise on their demands.”
  • The Congressional Budget Office tells us,
    • “The Congressional Budget Office regularly updates the Congress on our projections of the Hospital Insurance (HI) Trust Fund’s financial position as well as changes in our outlook on that position. This blog post serves as that update.
    • “The HI trust fund is used to pay for benefits under Medicare Part A, which covers inpatient hospital services, care provided in skilled nursing facilities, home health care, and hospice care. The fund derives its income from several sources. Over the next 30 years, about three-quarters of its annual income comes from the Medicare payroll tax and roughly one-eighth comes from income taxes on Social Security benefits. The rest comes from other sources.” * * *
    • “The year in which the HI trust fund’s balance is exhausted in our current projections, 2040, is 12 years earlier than in our most recent estimate of that date, which was published in March 2025. Measured in relation to taxable payroll, the trust fund’s 25-year actuarial deficit is 0.17 percentage points greater in the current projections than in last year’s. (Measured in relation to GDP, the actuarial deficit is 0.07 percentage points greater than we projected last year.) Those changes are driven largely by projections of less income to the fund. Projections of greater spending also contribute to the changes.”
  • STAT New reports,
    • “More evidence is starting to show the government’s arbitration process to settle out-of-network bills has morphed into a cash cannon for doctors and medical groups.
    • “Jinghong Chen of Payer Perspectives sifted through the latest federal data covering the arbitration process created by the No Surprises Act and found that not only are medical groups winning nearly nine out of every 10 cases, they are also getting paid more than anyone can imagine.
    • “The NSA’s arbitration process encouraged the use of the “qualifying payment amount” — essentially the average in-network rate that providers in a given area have agreed to — as a benchmark for disputes. How quaint. Instead, medical groups have fought for, and won, astronomically higher amounts. 
    • “Radiologists are winning offers that are, on average, almost 500% of the typical in-network rate, according to Chen’s analysis. Surgeons are getting payments for contested services that are a median 1,320% above the in-network rate. Neurology and neuromuscular procedures have median winning offers of nearly 2,400% above the in-network average.”
  • Govexec informs us,
    • “Federal supervisors are poised to soon face limitations on how many employees they can rate as above average in their annual performance reviews after the Trump administration on Monday proposed upending the process for evaluating civil servants. 
    • “The Office of Personnel Management’s proposed rule would implement the first major overhaul of the federal employee performance management system in decades. The Trump administration is aiming to correct for what it views as inflated ratings within the federal workforce. 
    • “The rule, which OPM will formally release on Tuesday, largely mirrors a draft version Government Executive exclusively obtained and reported on in December.”
  • The Affordable Care Act regulators announced today their decision to extend the public comment period for the proposed rule that appeared in the Federal Register on December 23, 2025, titled “Transparency in Coverage” from February 23, 2026, to March 2, 2026.
  • The New York Times reports,
    • “Adding to a rapid shake-up of the leadership at federal health agencies, the Centers for Disease Control and Prevention announced on Monday that Dr. Ralph Abraham had resigned as the agency’s principal deputy director.
    • “His departure thins the ranks of vaccine skeptics at the agency’s helm, a sign of the administration’s pivot away from the agenda pursued thus far by Health Secretary Robert F. Kennedy Jr. and his appointees.
    • “Dr. Abraham’s resignation, which comes less than three months into the job, was effective immediately, the agency said in a statement on its website.” 

From the Food and Drug Admininstration front,

  • Beckers Hospital Review tells us,
    • “Eli Lilly has launched a multidose version of its blockbuster weight loss drug Zepbound that gives patients a month’s worth of treatment in a single injection pen.  
    • “On Feb. 23, the drugmaker said the FDA approved a label expansion for Zepbound (tirzepatide) to include the four-dose, single-patient-use KwikPen. The device contains four weekly doses, reducing the number of pens patients need each month compared with single-dose injectors.
    • “The KwikPen will be available by prescription for self-paying patients through LillyDirect, Eli LIlly’s direct-to-consumer platform. Prices start at $299 per month for the lowest dose. Patients choosing the self-pay option can access all approved doses in either the multidose pen or single dose vial at the same price, the company said.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued draft guidance for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations. 
    • “The draft guidance, issued by the Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, specifically discusses genome editing and RNA-based therapies such as antisense oligonucleotides but leaves open the potential that this framework may apply to additional tailored therapeutics provided they directly address the underlying specific cause of the disease.” * * *
    • “The draft guidance, Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause, is available for public comment. Comments must be submitted within 60 days of publication in the Federal Register at Regulations.gov.”
  • Per Fierce Pharma,
    • “Vanda Pharmaceuticals is riding a regulatory roller coaster over the last few months. December brought an FDA thumbs up for its new motion sickness drug Nereus. Then in January, the U.S. regulator re-upped its rejection of Vanda’s Hetlioz for jet lag disorder.
    • “Now in February, the agency has issued another new drug approval to Vanda, signing off on Bysanti as a first-line treatment for schizophrenia or for manic or mixed episodes associated with bipolar I disorder. 
    • :The atypical antipsychotic tablet, also known as the chemical compound milsaperidone, has demonstrated in clinical trials its bioequivalence to Vanda’s Fanpat (iloperidone), which has been approved in the same two indications.”
  • and
    • “Only a month after Jazz Pharmaceuticals said it had signed a deal to sell an FDA priority review voucher (PRV) for $200 million, a new PRV transaction involving Fortress Biotech and an unnamed buyer shows that the trend of rising voucher prices is still going strong.
    • “Monday morning, Fortress said its subsidiary, Cyprium Therapeutics, has entered into an agreement to sell a recently received rare pediatric disease priority review voucher for $205 million. Cyprium got its hands on the PRV as part of the FDA’s recent approval of injected copper replacement therapy Zycubo as the first treatment approved in the U.S. for the rare neurodegenerative disorder Menkes disease.
    • “While another company, Sentynl Therapeutics, is handling development and commercialization of Zycubo under a 2023 agreement, the deal called for Sentynl to transfer the PRV back to Fortress/Cyprium after the approval.”  

From the public health and medical / Rx research front,

  • STAT News reports,
    • “Women’s bodies are different from men’s in ways that medicine is still learning. Meanwhile, their risk of serious cardiovascular events can be underestimated if their distinct risk profiles are blurred with men’s. 
    • “The latest example of important sex differences centers on the plaque burden in coronary arteries — a measure of fat and cholesterol deposits that also accounts for blood vessel size. 
    • “Women tend to have lower volumes of plaque than men, but their total plaque burden is higher because the fatty deposits take up a larger fraction of their smaller coronary arteries. Their risk for a heart attack or hospitalization for chest pain emerged when their plaque burden was lower than men’s, and their risk climbed more steeply, too, a new study published Monday in Circulation: Cardiovascular Imaging concluded.”
  • The Washington Post relates,
    • “Obstetrician Jeanne Conry has long paid attention to the “1,300-day window”— the months before conception through a child’s second birthday. Studies show nutrition and lifestyle during this period can shape pregnancy outcomes and the long-term health of the babies. Conry began to wonder if such factors could also influence autism.
    • “She is now helping lead an educational push aimed at alerting women to their exposure to toxins, stress and infections during this narrow and consequential window — guided by the idea that what happens then may subtly shape eggs or sperm, and in turn, influence a child’s development long before pregnancy begins.
    • “The more we research, the more we see links between different chemical exposures and autism so if we reduce those links we will ideally reduce cases,” Conry said.”
  • STAT News also informs us,
    • “Novo Nordisk’s next-generation weight loss drug CagriSema, one of the company’s key hopes to help it regain its footing in the increasingly competitive obesity market, failed in a key study that compared it to rival Eli Lilly’s tirzepatide, Novo said Monday. 
    • “The open-label REDEFINE 4 study was designed to test whether CagriSema could help patients lose the same amount of weight as those who received tirzepatide, which is sold as Zepbound and Mounjaro. But over 84 weeks, patients in the CagriSema arm saw a weight loss of 20.2%, versus 23.6% for those getting tirzepatide. Statistically, the results did not show that CagriSema performed equivalently to Lilly’s drug — what’s known as non-inferiority.” 
  • The Hill adds,
    • “An ingredient in the prescription diabetes drug Mounjaro was found to reduce alcohol intake in rodents, according to a recent study. 
    • “In the study, published in early January in the medical journal eBioMedicine, researchers in Sweden, South Carolina and Brazil looked at how the ingredient, tirzepatide, affected rodents. The researchers found that alcohol’s “rewarding properties” were lessened by the ingredient and that behaviors including the voluntary consumption of alcohol and binge drinking dropped.
    • * * * “In summary, our findings indicate that tirzepatide influences alcohol-related responses in ways that appear to have clinical potential. Tirzepatide consistently reduced alcohol intake across different drinking paradigms and both sexes without signs of tolerance development,” the researchers wrote.
    • “Perhaps more significantly, tirzepatide’s effects on relapse behaviours suggest it might help decrease relapse vulnerability, a finding that could prove important for therapeutic applications,” they added.”
  • The American Medical Association lets us know “What doctors wish patients knew about food allergies.”
    • “Milk, eggs, peanuts, tree nuts, fish, shellfish, wheat, soy and sesame are the “Big Nine” food allergies. Two allergists share more about food allergies.”
  • NPR adds,
    • “Ultra-processed foods are industrially manufactured products that contain ingredients rarely found in your kitchen, such as preservatives, artificial sweeteners, colorings, natural flavors and emulsifiers. Numerous studies have shown that these foods increase the risk of a host of health problems, including diabetes, heart disease, depression and obesity.
    • “When people ask me about ultra-processed foods, they’re often most confused about grains, carbohydrates and starches,” says Dr. Dariush Mozaffarian, who leads the Food is Medicine Institute at Tufts University. These foods include breads, crackers, pretzels, pea snaps, veggie straws, pastas and puffed rice or corn. “People want to know how to choose more healthful versions of these products,” he says.
    • “So Mozaffarian gives his patients two practical rules of thumb to follow when selecting grains and starches: the 10 to 1 test and the water test.”
  • Cardiovascular Business points out,
    • “The risk of death following percutaneous coronary intervention (PCI) remains incredibly low, according to new findings published in The American Journal of Cardiology.[1] When it does occur, acute myocardial infarction (AMI), cardiac arrest and infection are two of the most common reasons.
    • “Estimating the risk of periprocedural mortality after percutaneous coronary intervention (PCI) is crucial for risk stratification and quality assessment,” wrote Dimitrios Strepkos, MD, a researcher with the Minneapolis Heart Institute Foundation, and colleagues. 
    • “Strepkos et al. examined data from the PROGRESS-COMPLICATIONS registry, focusing on more than 22,000 patients who underwent PCI from 2014 to 2024 at one of two high-volume U.S. facilities. The overall technical success rate was 78.3%. While 14.8% of patients underwent atherectomy as part of the procedure, 6.1% underwent intravascular lithotripsy.”

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

  • The Wall Street Journal reports,
    • “Merck MRK is shaking up the leadership of its main pharmaceutical unit as the U.S. drugmaker braces for sales pressure later this decade.
    • “The Rahway, N.J.-based company said Monday it will split its human-health business into two divisions. One will house its cancer drugs, including the blockbuster Keytruda. The immunotherapy accounts for nearly half of total Merck sales but is due to lose U.S. patent protection in 2028, exposing it to lower-cost copycat competition.
    • “The second new division—the specialty, pharma and infectious-diseases business unit—will sell noncancer products, including the HPV vaccine Gardasil, diabetes drug Januvia and newer products such as lung-disease treatment Winrevair. 
    • “Merck is counting on this unit to generate big sales growth to offset the expected Keytruda sales decline.” 
  • Beckers Hospital Review reports,
    • “Nacogdoches (Texas) County Hospital District is eyeing a new lease agreement with Dallas-based Tenet Healthcare that would merge Nacogdoches Memorial Hospital with Nacogdoches Medical Center, ABC affiliate KTRE reported Feb. 19.
    • “Under the proposed deal, the two hospitals would operate under unified management.
    • “Consolidating the hospitals would help the district sustain care for the community’s underserved population while benefiting from the resources and support of a larger health system, David Schaefer, vice president of the hospital district’s board, told the media outlet.” 
  • MedTech Dive notes,
    • “Guardant Health has acquired MetaSight Diagnostics for $59 million in upfront cash to bolster its multi-disease detection pipeline, the company said Thursday. The deal includes up to $90 million in payments tied to future commercial performance and regulatory approvals.
    • “MetaSight uses mass spectrometry multi-omics technology to find biomarkers associated with acute and chronic diseases in serum samples. Tests for colorectal cancer, an area of focus for Guardant, and liver disease-associated fibrosis were MetaSight’s two most advanced programs just before the acquisition.”  
  • Fierce Healthcare points out,
    • “As providers rapidly adopt artificial intelligence technology for clinical documentation, there is a demand for AI clinical assistants that meet the needs of specialty medicine practices.
    • “Health tech company Nextech recently launched its next-generation AI assistant, called Cora, along with its clinical documentation feature, Cora Scribe, to provide AI technology that was designed with specialty workflows in mind, according to the company.
    • “Nextech provides electronic medical record and practice management software to specialty physician practices as well as revenue cycle management (RCM), customer relationship management (CRM) and other software systems. The company supports 16,000 physicians, more than 5,500 practices and 60,000 office staff members in the clinical specialties of dermatology, ophthalmology, orthopedics, plastic surgery and medical spa practices.”
  • The American Hospital Association News adds,
    • “The AHA responded to a request for information today from the Department of Health and Human Services on the adoption and use of artificial intelligence in clinical care. The AHA urged HHS to synchronize and leverage existing AI policy frameworks to avoid redundancy, remove regulatory barriers that inhibit the development and deployment of AI tools, adopt policies ensuring the safe and effective use of AI, and align incentives and address infrastructural factors necessary to expand AI in health care.  
    • “The AHA’s comments build upon previous responses to RFIs on regulation and reimbursement for AI, including an RFI from the Office of Science Technology Policy on ways to reduce regulatory burden for AI, an RFI from the Food and Drug Administration on measuring and evaluating AI-enabled medical devices, and RFIs from the Centers for Medicare & Medicaid Services on payment for AI tools through the calendar year 2026 Outpatient Prospective Payment System proposed rule and CY 2026 Physician Fee Schedule proposed rule.”

Weekend Update

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

Happy Washington’s Birthday!

From Washington, DC,

  • The President will give his State of the Union address Tuesday night, February 24.
  • Roll Call offers more details on this week’s activities on Capitol Hill.
  • Per a Department of Homeland Security news release, TSA is closing pre-check and Global Entry lines at airports starting today due to the continuing DHS shutdown. Other steps are identified in the release.
  • The Washington Post adds,
    • “The Department of Homeland Security reversed course Sunday morning after saying that it would suspend TSA PreCheck because of the partial government shutdown.
    • “TSA PreCheck remains operational with no change for the traveling public,” the Transportation Security Administration said in a statement. “As staffing constraints arise, TSA will evaluate on a case by case basis and adjust operations accordingly.”
    • “A DHS official, speaking on the condition of anonymity to discuss internal processes, said the change was “based off of conversations the secretary had with the White House and TSA.
    • “The Global Entry program, however, will remain paused, according to the official.”
  • Healthcare Dive reports,
    • “GE HealthCare has won a $35 million U.S. government contract expansion to develop artificial intelligence-enabled ultrasound technology for trauma care, the company said Tuesday.
    • “Building on a deal made in 2023, GE HealthCare will develop AI-powered tools to make it faster and easier for people, including non-expert ultrasound users, to diagnose patients.
    • “GE HealthCare is jointly funding the latest phase of the project, although it said the Biomedical Advanced Research and Development Authority will provide most of the money.”
  • The GAO Watchblog informs us
    • “The federal government makes all kinds of payments each day, everything from Social Security benefits to payments for weapon systems. But sometimes errors occur, including payments to dead people. 
    • “A pilot program has helped to reduce how often these errors occur. And it was so successful that the president recently signed a law to make it permanent—an action that GAO recommended. While the program helped reduce payment errors, it comes with financial costs that should be addressed. 
    • “Today’s WatchBlog post looks at our new report on the success of this effort and its costs. “

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “The hours you spend tracing countries on a globe or puzzling over a chessboard may add up to more than idle time. According to a new study, such mentally stimulating pursuits are linked to years-long delays in Alzheimer’s disease and mild cognitive impairment.
    • “Published this month in Neurology, the journal of the American Academy of Neurology, the study is among the largest of its kind, following 1,939 adults with an average age of 80 and tracing their cognitive trajectories alongside a lifetime of reported activities stretching back to childhood.
    • “The contrast between the most and least cognitively enriched participants was stark. Those in the top 10 percent developed Alzheimer’s at an average age of 94; those in the bottom 10 percent, at 88. Mild cognitive impairment showed a similar split: 85 in the highest group, 78 in the lowest.
    • “Five years’ difference for Alzheimer’s. Seven for mild cognitive impairment.
    • “I was positively surprised,” Andrea Zammit, a study co-author and an assistant professor of psychiatry and behavioral sciences at Rush University Medical Center in Chicago, said.”
  • Health Day adds,
    • Skip your late-evening snack and wind down for the day with the lights dimmed low.
    • That simple shift in your end-of-the-day routine is good for your heart, new research demonstrates.
    • “Timing our fasting window to work with the body’s natural wake-sleep rhythms can improve the coordination between the heart, metabolism and sleep, all of which work together to protect cardiovascular health,” said study author Dr. Daniela Grimaldi, a research associate professor of neurology in sleep medicine at Northwestern Feinberg School of Medicine in Chicago.
    • The sweet spot is three hours.
    • Dimming lights and avoiding food that long before bed resulted in measurable gains in heart and metabolic markers during sleep and the entire next day, she and her colleagues reported Feb. 12 in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.
  • MedTech Dive relates,
    • “Apple Watch’s hypertension notification feature may miss some casesacross different patient demographics, according to a research letter published last week in JAMA.
    • “Researchers at the University of Pennsylvania and University of Utah applied performance metrics for the feature to U.S. population statistics to estimate its impact. They found about 69% of people who received an alert have hypertension, and about 79% of people who don’t receive an alert do not have hypertension. The feature’s performance varied by age, race and ethnicity.
    • “Jordana Cohen, the study’s lead author and an associate professor of medicine and epidemiology at the University of Pennsylvania School of Medicine, wrote in an email that the analysis suggests an alert meaningfully increases the likelihood that a person has hypertension. “However, the absence of an alert provides limited reassurance, particularly in older and higher-risk adults, and routine blood pressure measurement with validated cuff-based devices remains essential,” Cohen wrote.”
  • MedPage Today tells us “What to Know About ALS After Actor Eric Dane’s Death.”
    • “Actor Eric Dane, known for his role in “Grey’s Anatomy,” died this week at age 53, less than a year after announcing he had amyotrophic lateral sclerosis (ALS).
    • “Dane became an advocate for ALS awareness soon after his diagnosis in April 2025 and was named the recipient of the ALS Network Advocate of the Year Awardopens in a new tab or window last September.
    • “Eric’s passing is a huge loss for our ALS advocacy community,” said Evangelos Kiskinis, PhD, associate professor of neurology and neuroscience at Northwestern University Feinberg School of Medicine in Chicago.”

From the U.S. healthcare business front,

  • Fierce Healthcare adds,
    • “Virtual care company Omada Health is expanding its cardiometabolic care management platform with supports for individuals with high cholesterol.
    • “The company said Thursday that while as many as 70% of adults with obesity also have elevated cholesterol levels, many of these individuals never reach healthy levels for their cholesterol, highlighting a key gap for many patients who are managing cardiometabolic conditions.
    • “Omada for Cholesterol will bring its artificial-intelligence-powered and human-led coaching approach to cholesterol management and embed it within the broader platform for managing weight, blood pressure and diabetes.”

Tuesday Report

David Ermer–Congress, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, HSA, Medical / Rx research, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports.
    • “The Congressional Budget Office last week put out an “are you sitting down?” report that projected the U.S. government will spend $1 trillion on interest payments for its debt this year. One. Trillion. Dollars. To finance its gigantic and growing debt. And it will only get worse from there.
    • “It also projected that the U.S. government will spend $1.853 trillion more than it brings in through revenue this year (that’s the budget deficit) and have an even wider gap in 2027. Talks of slashing spending and making difficult choices last year have given way to election-year spending-increase promises in 2026. Perhaps complicating matters more, DOGE never really caught on in 2025, and Republicans seem reluctant to repeat that experiment any time soon.
    • “Budget angst tends to come in waves, but the debt never stops growing. I wrote about the $13.7 trillion debt here in 2010. That was $25 trillion ago.”
  • and
    • “The [Homeland Security Department] shutdown enters Day 4, with little chance of an end in sight after Congress failed to reach a deal on immigration-enforcement policies.”
  • Federal News Network reminds us about the bipartisan federal employment bills brewing in Congress.
  • Last Friday, the HHS Office for Civil Rights posted model HIPAA notices of privacy practices that were update for the Part 2 changes.
  • Navia Benefits lets us know,
    • “Health Savings Accounts (HSAs) have traditionally been viewed as a tax-advantaged way to pay for out-of-pocket medical expenses. But today’s data tells a much bigger story: they can function as a powerful financial wellness tool.
    • “HSAs are increasingly operating like powerful long-term investment vehicles rather than just spending accounts. Yet misconceptions persist across the workforce, and employee education continues to lag. With rising healthcare costs and growing financial pressures, it is a good time to elevate the HSA conversation.
    • [Navia’s article] examines the triple tax advantages, workforce perception trends, and evidence-based insights to guide employers in maximizing HSA participation and value.

From the Food and Drug Administration front,

  • Per a Senate news release,
    • :U.S. Senator Bill Cassidy, M.D. (R-LA), chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a landmark report detailing legislative and regulatory reforms to modernize the Food and Drug Administration (FDA). These proposals aim to maintain American biomedical dominance and ensure patients have timely access to the latest lifesaving treatments. The HELP Committee’s recommendations are directly in line with President Trump’s mission to improve the health of American children and families.
  • Fierce Pharma tells us,
    • “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.”
  • and
    • “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 approvedas an every-two-week regimen.
    • “For weeks 1 through 4, patients must still receive weekly doses of Rybrevant Faspro. Beginning week 5, the doses can shift to monthly administration.”

From the judicial front,

  • The Wall Street Journal reports,
    • “Bayer BAYN is making a new multibillion-dollar push to resolve a years long legal nightmare over Roundup weedkiller.
    • “The German pharmaceutical and agriculture conglomerate on Tuesday said it proposed to settle a nationwide class-action lawsuit to resolve claims that its flagship herbicide causes cancer. The settlement plan includes setting aside more than $7 billion to fund payments over 21 years. 
    • “Law firms representing tens of thousands of plaintiffs filed a motion Tuesday seeking approval of the settlement. The proposal requires court approval in Missouri, where the bulk of Roundup cases are outstanding.” 

From the public health and medical / Rx research front,

  • Patient Care reports,
    • “New data from the 2026 Primary Care Scorecard highlight measurable associations between regular primary care access and improved outcomes for patients with chronic disease.
    • “In the interview, Morgan McDonald, MD, National Director for Population Health at the Milbank Memorial Fund and practicing primary care internist and pediatrician, outlined key findings relevant to frontline clinicians.
    • “Among adults with chronic disease, having a usual source of care was associated with:
      • 20% lower hospitalization rates
      • 54% lower total cost of care
    • “For children with chronic disease, reductions in emergency department visits and hospitalizations for ambulatory care–sensitive conditions—such as pneumonia and otitis media—were “cut roughly in half.”
    • “The report also reinforces primary care’s role in prevention. Nearly all adults with a usual source of care received preventive services for conditions such as cardiovascular disease and common cancers, compared with approximately two-thirds of adults without a regular source of care. Similar trends were observed in pediatric populations, including higher receipt of counseling related to nutrition, exercise, injury prevention, and obesity prevention.”
  • Infectious Disease Advisor tells us,
    • “Low rates of diagnostic testing for respiratory syncytial virus in adult outpatient settings may result in an underestimated disease burden, potentially impeding the effective use of novel vaccines and therapeutic interventions.” 
  • MedPage Today informs us,
    • “Health systems where most pregnant patients have a high or moderate risk for preeclampsia may benefit from universal dispensation of aspirin, results from a large cohort study suggested.
    • “The rate of preeclampsia with severe features at a Texas health system was a relative 29% lower after it implemented universal aspirin dispensation in prenatal care compared with the period when aspirin was not recommended, regardless of risk factors (5.2% vs 7.1%; OR 0.71, 0.66-0.78, P<0.001), Elaine Duryea, MD, of University of Texas Southwestern Medical Center in Dallas, reported here.”
  • Medscape points out the top ten triggers for pancreatic cancer which is “an often silent disease.”
  • STAT News reports,
    • “Compass Pathways on Tuesday disclosed results from two Phase 3 studies that support a potential approval of its psilocybin treatment for severe depression, but more detailed data are needed to determine how beneficial the drug would be for patients.
    • “In both trials, patients who received the company’s psychedelic medicine saw greater improvements on a measure of depression than the control group, Compass said in a press release. Its drug, called COMP360, could be the first psilocybin product on the market and the second psychedelic approved after Johnson & Johnson’s Spravato, a ketamine derivative.
    • “Taken together, the data “probably meets the bar for approval. It doesn’t shout out to you that this is miraculous,” said Jerry Rosenbaum, director of Massachusetts General Hospital’s Center for Neuroscience of Psychedelics, who was not involved with the study.”
  • and
    • Ocular Therapeutix said Tuesday that its experimental treatment, called Axpaxli, maintained vision with less frequent injections compared to a standard treatment for patients with a common cause of age-related blindness — achieving the primary goal of a late-stage clinical trial. 
    • “However, the difference in the durability of treatment between Axpaxli and the active control in the study was narrower than investors expected — a finding that may spark debate about Axpaxli’s commercial potential in wet age-related macular degeneration, where effective drugs are already approved.”
  • Fierce Pharma adds,
    • “Continuing the reinvention of its cancer drug Gazyva as a treatment for immune-mediated diseases of the kidney—which resulted in a lupus nephritis nod last fall—Roche is touting new data that could tee up the antibody for a world-first approval.
    • “In an early look at results from the late-stage Majesty study in adults with primary membranous nephropathy, Gazyva (obinutuzumab) helped significantly more patients achieve complete remission at the two-year mark compared with the immunosuppressant tacrolimus, Roche said in a Feb. 16 press release. 
    • “Gazyva’s performance enabled the trial to hit its primary endpoint, and key secondary endpoints further pointed to statistically significant and clinically meaningful outcomes on overall remission at Week 104 and complete remission at Week 76 of the study, the company said.” 
  • Genetic Engineering and BioTechnology News relates,
    • “Researchers headed by a team at the University of California, Irvine, Joe C. Wen School of Population & Public Health have built what they suggest is the first cell type-specific gene regulatory network (GRN) map for Alzheimer’s disease (AD), which shows how genes causally regulate one another across different types of brain cells affected by AD.
    • “The researchers developed a machine learning framework, SIGNET (Statistical Inference on Gene Regulatory Networks), which reveals cause-and-effect relationships rather than simple genetic correlations, and applied this to uncover key biological pathways that may drive memory loss and brain degeneration. Their results pointed to numerous influential “hub genes” that offer promising potential new targets for early detection and therapeutic intervention. The investigators say their methodology is also applicable to other complex diseases, including cancer.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ongoing headwinds caused by elevated utilization and medical costs continued to drag major health plans in the fourth quarter, completing the story of a complex 2025 for the industry.
    • “The most profitable company for the full-year was UnitedHealth Group, with $12.05 billion in earnings for 2025. The healthcare giant had a sizable lead on the next-highest payer in terms of profitability, which was Cigna at just below $6 billion.
    • “However, the company posted just $10 million in profit for Q4, the lowest tally among payers that turned a profit in the quarter. In Q4, the company saw a medical loss ratio of 92.4%, which settled to 89.1% for the full year.”
  • Fierce Healthcare adds,
    • “CommonSpirit Health’s adjusted operating margin inched into the black during the three months ended Dec. 31 as the organization’s leadership touted “noticeable” quarter-to-quarter performance gains stemming from strong volumes and efficiency. 
    • “The 138-hospital Catholic nonprofit posted a $78 million operating loss (-0.8% operating margin) for the second quarter of its 2026 fiscal year; however, after normalizing for delayed income received through California’s provider fee program, the system reached a narrow operating income of $2 million (0.0% operating margin). 
    • “CommonSpirit also reported $456 million excess revenues over expenses after normalizing. A year prior and after adjustment, the organization had an operating income of $135 million (1.3% operating margin) and a $356 million bottom line, which it noted was bolstered by around $352 million of Federal Emergency Management Agency grant revenue.”
  • Per Beckers Hospital Review,
    • “Ontario, Calif.-based Prime Healthcare’s nonprofit public charity, Prime Healthcare Foundation, acquired Lewiston-based Central Maine Healthcare on Feb. 16.
    • “The foundation received Maine’s approval to acquire Central Maine Healthcare in late November after sharing plans to acquire it in January 2025. 
    • “The transaction comprises Lewiston-based Central Maine Medical Center, Bridgton (Maine) Hospital, Rumford Hospital, Rumford (Maine) Community Home, Auburn, Maine-based Bolster Heights Residential Care, Lewiston-based Maine College of Health Professions, Lewiston-based CMH Cancer Care Center, and more than 40 physician practices, according to a Feb. 16 news release.
    • “The Prime Healthcare Foundation comprises 21 hospitals across the U.S. following the acquisition, with more than $4 billion provided in charity care.” 
  • and
    • “Marshfield Medical Center-Wisconsin Rapids Campus will open to patients March 1.
    • “The campus includes the soon-to-open hospital and Marshfield Clinic Wisconsin Rapids Center, according to a Feb. 16 health system news release.
    • “The hospital will include inpatient beds, an emergency department, exam and procedure rooms, radiological services that include general x-ray, computed tomography and ultrasound, and on-site laboratory testing.”
  • and
    • “Telehealth company eMed has partnered with CVS Caremark to offer a GLP-1 benefit model that lets employers subsidize weight loss medications without covering the full cost, Axios reported Feb. 16. 
    • “The arrangement allows eligible employees to purchase GLP-1s online through eMed and receive weight management services including side effect management, weekly check-ins and blood testing. Employers can decide how much of the cost to subsidize, the report said.” 
  • Per Healthcare Dive,
    • “Amwell is projecting lower revenue in 2026 after the health technology firm divested assets, executives said during an earnings call Thursday. 
    • “The firm expects revenue from $195 million to $205 million this year. In comparison, the telehealth vendor and health tech firm brought in revenue of $249.3 million in 2025.
    • “The top line for 2026 is smaller, but it’s “primarily high-quality, high-upside, sticky revenue,” CEO Ido Schoenberg said on the call.”
  • Per MedTech Dive,
    • “Danaher said Tuesday it has agreed to acquire patient monitoring company Masimo for $9.9 billion to bolster its diagnostics franchise.
    • “Masimo will become a standalone business unit and brand within Danaher’s diagnostics portfolio, operating autonomously while strengthening Danaher’s offering in acute care settings, the companies said.
    • “Masimo’s advanced sensor technology and AI-enabled monitoring bring powerful new capabilities to our diagnostics portfolio,” Julie Sawyer Montgomery, Danaher’s executive vice president for diagnostics, said in a statement.
    • “The $180-per-share cash deal has been unanimously approved by both Masimo’s and Danaher’s boards, according to Masimo.”

Holiday Weekend Update

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

Happy Presidents’s Day!

  • Congress is on recess this week unless a bipartisan settlement over the issues causing the Department of Homeland Security shutdown is reached midweek.
  • On Friday February 20, 2026, the U.S. Supreme Court may announce opinions, which are posted on the homepage after announcement from the Bench.
  • STAT News reports,
    • “The Medicare Advantage program continues to bring in more older adults and people with disabilities, but not nearly at the same rates from just a few years ago.
    • “Almost 35.5 million people were enrolled in a Medicare Advantage plan as of Feb. 1, up roughly 3% from 34.4 million at the same time in 2025, according to new federal data analyzed by STAT. The growth during Medicare’s annual enrollment window, which runs from Oct. 15 through Dec. 7, stagnated — with enrollment increasing just 1%.
    • “By comparison, annual enrollment growth in Medicare Advantage ranged between 7% and 10% between 2017 and 2024, according to historical data analysis by STAT.”
  • Federal News Network interviews Jonathan Smith, the new President of the American Postal Workers Union. “Smith started his leadership role last November. He’s been a member of APWU since 1988, and previously served as president of APWU’s largest local, the New York Metro Area Postal Union.”

From the public health and medical / Rx research front,

  • Insurance News Net reports,
    • “According to MetLife research, less than half of America’s workforce is holistically healthy, as employees battle rising costs and employers balance investing in benefits with broader cost-cutting measures. These early findings from MetLife’s 2026 U.S. Employee Benefit Trends Study (EBTS) underscore the challenge of sustaining workforce well-being and engagement in an environment in which employees and employers are financially strained, the report said.
    • “MetLife’s EBTS defines holistic health as a combination of physical, mental, financial and social health.
    • “Highlights of the study include:
      • “83% of employees said that rising living expenses and medical costs are their top stressors and 77% said that economic uncertainty is a major concern.
      • “On average, employees miss 6.1 days of work because of health-related issues and 50% of key employees often avoid seeking medical care because of out-of-pocket costs.
      • “Employers cited “controlling health care costs” as the #1 benefits objective. This surpasses productivity, loyalty, and attracts new talent for the first time since 2022.
      • “60% of employers increased their investment in benefits and 62% expanded their non-medical offerings.
      • ‘As overall workforce well-being has stalled, with just 44% of employees report feeling holistic healthy and engagement, loyalty and productivity remain flat.”
  • NBC News relates,
    • “The recent death of the 48-year-old actor James Van Der Beek is again highlighting how colorectal cancer is increasingly killing younger people.”
    • “Overall, cancer death rates in people younger than 50 have dropped by 44% since 1990. But after increasing for decades, colorectal cancer is now the leading cause of cancer death in people under 50. Colorectal cancer starts either in the colon or rectum. 
    • “Overall, cancer death rates in people younger than 50 have dropped by 44% since 1990. But after increasing for decades, colorectal cancer is now the leading cause of cancer death in people under 50. Colorectal cancer starts either in the colon or rectum. 
    • “Federal cancer screening guidelines and the American Cancer Society recommend that people who have an average risk for colorectal cancer should begin screening at age 45 with a colonoscopy every 10 years, or a stool test every one to three years. Insurance companies use the guidelines to determine whether the screening is covered.” * * *
    • “It’s clear that colorectal cancer rates are rising among young people, but the cause is still poorly understood.
    • “Research suggests that rising rates of obesity and declining physical activity, changes in the gut microbiome and diets high in ultraprocessed foods, which have become more common since the 1980s, are largely to blame. Some early research has also suggested that antibiotic use and having certain bacteria in the gut could also play a role. 
    • Dr. Andrew Chan, a gastroenterologist and chief of the clinical and translational epidemiology unit at Mass General Brigham in Boston “said that while screening is important, people should also focus on improving their diet and getting enough exercise, two lifestyle factors that have been shown to significantly reduce a person’s risk of colorectal cancer. 
    • “Those types of interventions will hopefully have benefits that extend beyond screening,” he said. “Screening is important, but I don’t want us to ignore those other factors.”
  • The American Medical Association lets us know “what doctors wish patients knew about stress management.”
    • “Whether it is using a stress ball or practicing yoga, stress relief is key. Brian Chaney, MD, of Baptist Health, offers tips for relief from stress.”
  • Per MedPage Today,
    • “Lifelong intellectual activity, such as reading or museum visits, was tied to lower Alzheimer’s dementia risk in older adults.
    • “Adults with the highest level of cognitive enrichment developed mild cognitive impairment about 7 years later than others.
    • “Results persisted even after adjusting for Alzheimer’s pathology, suggesting strong cognitive resilience.”
  • and
    • “Adherence to one of five healthy diets was tied to lower mortality risk and added up to 3 years to lifespan.
    • “Associations remained robust regardless of genetic predisposition for longevity.
    • “Diet focused on reducing diabetes risk showed the strongest link with lower death risk.”
  • Cardiovascular Business tells us,
    • “Childhood obesity is associated with a significant risk of vascular damage, according to a new study of children between the ages of six and 11 years old. Researchers hope these findings make it clear just how important it is to prevent childhood obesity and encourage young children—with help from their families—to make healthy eating choices.
    • ‘The new analysis, published in the International Journal of Obesity, focused on 113 children who were categorized as either having a healthy weight or being overweight/obese. Each child was assessed using peripheral arterial tonometry. Overall, overweight and obese children performed worse on the reactive hyperemia index, a measurement of endothelial function. These children also had higher TNF-alpha gene expression and elevated levels of endothelial microparticles, which are both signs of vascular inflammation. Such inflammation has a long-term impact on the body, causing immune cells to age prematurely and doing permanent damage.
    • “The results of the study reinforce the seriousness of childhood obesity, showing that it needs to be reversed early on. We also warn about the need for public policies to reduce obesity in childhood, especially in socioeconomically vulnerable populations,” senior author Maria do Carmo Pinho Franco, a professor at the Federal University of São Paulo in Brazil, said in a statement.”

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

  • Modern Healthcare reports,
    • “Humana completed its acquisition of the primary care clinic operator MaxHealth from private equity firm Arsenal Capital Partners.
    • “The deal adds 54 primary care clinics, four specialty sites and 24 affiliated facilities to Humana’s CenterWell healthcare services arm.
    • “The companies did not disclose financial details of the acquisition, and Humana declined to comment.
    • “Related: Humana is said to be near $1B deal for MaxHealth
    • “Tampa, Florida-headquartered MaxHealth counts more than 120,000 Medicare and Medicaid patients as customers, according to a Friday news release.”
  • Cardiovasular Business informs us,
    • “Boston Scientific has agreed to acquire Penumbra, a California-based medtech company focused on vascular technologies, for approximately $14.5 billion. This is a cash and stock transaction that values Penumbra at $374 per share.
    • “Penumbra is known for its mechanical thrombectomy devices, including those used to perform peripheral vascular disease treatments, and a variety of offerings in the neurovascular space. The company, founded in 2004, currently has more than 4,500 employees and expects its 2025 revenue to total approximately $1.4 billion. That figure represents growth of more than 17% compared to the previous year. 
    • “Penumbra is a well-established company with an experienced, high-performing team and this acquisition offers Boston Scientific an opportunity to enter new, fast-growing segments within the vascular space,” Mike Mahoney, chairman and CEO of Boston Scientific, said in a prepared statement. “I’m thrilled to combine the talents and shared values of our teams—including welcoming Penumbra’s chairman and chief executive officer, Adam Elsesser, to our board of directors upon close. The addition of Penumbra can expand access for these novel technologies to more patients and customers around the world, further enhancing our revenue and margins over time with proven offerings that have a history of growth and innovation.”
  • The Wall Street Journal discusses the signficance of the movement towards direct to consumer sales of GLP-1 drugs.
    • “Ro, a competitor to Hims, points to a different path. Rather than leaning on legally murky, high-margin compounded drugs, Ro acts as a telehealth gateway for branded medications. Ro also sold compounded GLP-1s during the shortages, but both Eli Lillyand Novo Nordisk now sell their drugs on the platform. As CEO Zach Reitano explains: “Too many problems in our healthcare system exist because the patient does not control the flow of money at the point of purchase,” he says. “When they do, the system rewires itself.”
  • Beckers Hospital Review ranks physicians assistants’ pay by State.
    • “Compensation for physician assistants varies widely by state, with California reporting the highest mean PA income in 2024 at $151,351, according to the National Commission on Certification of Physician Assistants’ 2024 Statistical Profile of Board Certified PAs by State.
    • “Nationally, the mean PA income was $129,291.
    • ‘The data, released Feb. 12, reflect responses from PAs who were board certified as of Dec. 31, 2024. Income figures are based on PAs’ state of residence and reflect total income from all PA positions combined for the most recent calendar year reported by respondents. Midpoints of income ranges were used to calculate mean and median values.”
  • MedCity News observes,
    • “Health informatics leaders at NYU Langone Health think fully autonomous clinical AI is coming in the next five years or so, with algorithms soon able to manage routine tasks like blood pressure medication titration and diabetic retinopathy screening without human oversight. They argue automation is not just about efficiency, but also a practical and necessary solution to workforce shortages and system inefficiencies.”

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Roll Call tells us,
    • “As Congress spent months arguing over COVID-19-era enhanced premium tax credits that many people on the Affordable Care Act used to subsidize their health insurance, a relatively narrow debate over a single policy grew into a much broader and more complicated discussion about how to lower health care costs. 
    • “Concerns about those costs are a top issue for voters ahead of this year’s midterms. But whether Congress can meaningfully address the issue and how candidates communicate that idea to voters depends on the type of cost increases and what is driving them. 
    • “A main reason is that health-related costs mean different things to different people, such as higher insurance premiums, more expensive drugs, co-pay increases, surprise charges or unexpected gaps in coverage.
    • “Health care is probably the most complicated sector of the economy,” said Jonathan Burks, executive vice president of health and economic policy at the Bipartisan Policy Center. “I think when policymakers are talking about affordability, the reason that they can say ‘affordability’ and yet be nowhere near agreement on what they specifically want to do is because of that complexity.”
  • Federal News Network reports,
    • “The Trump administration is telling most agencies to proceed with terminating their collective bargaining agreements and derecognizing their federal unions in response to a pair of 2025 executive orders, despite ongoing litigation.
    • I”n a memo issued Thursday, Office of Personnel Management Director Scott Kupor advised all agencies covered by President Donald Trump’s orders to move forward with either amending or fully canceling their collective bargaining agreements. The president’s orders last year directed a majority of agencies to cancel their union contracts, citing “national security” concerns.
    • “For various reasons, including litigation, implementation of these executive orders at certain agencies and agency subdivisions has been delayed,” Kupor wrote in the Feb. 12 memo. “[OPM] now advises agencies and agency subdivisions covered by [the orders] that they should proceed to terminate or modify collective bargaining agreements.”
    • “The OPM memo tells agencies to notify their federal unions that the agreements are being terminated. It adds, though, that federal employees and agencies not covered by the two executive orders [here and here] can continue collective bargaining procedures as normal.”
  • NCQA announced the draft measurement year 2027 changes to its HEDIS quality measures. The public comment period ends on March 13, 2026 at 5 pm ET. HEDIS measures form a major part of OPM’s FEHB/PSHB plan performance assessment.
  • The American Hospital Association News relates,
    • “The Department of Health and Human Services Feb. 13 issued a request for information on a new 340B rebate model program. The RFI said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, will accept comments through March 19.
    • “The RFI asks 340B stakeholders to provide answers to a long list of questions so that HRSA can evaluate whether it should implement a 340B rebate model pilot program and how such a program might be designed. HRSA expressly encourages commenters to “include supporting facts, research, and evidence.”
    • “In a statement, Aimee Kuhlman, AHA vice president of advocacy and grassroots, said, “The AHA welcomes HRSA’s attempt to gather detailed information about the impact of a rebate model. We look forward to working with the agency to answer the many specific questions it has posed to 340B hospitals and other stakeholders. We hope that after careful consideration of comments from 340B hospitals and other stakeholders, HRSA will recognize that imposing hundreds of millions of dollars in costs on hospitals serving rural and underserved communities is not a sound policy.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration on Friday rejected bitopertin, a therapy developed by Disc Medicine to treat the rare blood disorder porphyria, which makes patients extremely sensitive to sunlight. 
    • “It’s the first experimental drug to go through FDA Commissioner Marty Makary’s new program to fast-track drug reviews. The agency previously approved a generic antibiotic through the new drug review program in December.
    • “The FDA, in its letter rejecting bitopertin, cited “uncertainties” about the correlation between the blood-based biomarker used as the efficacy goal in Disc’s clinical trials and clinical benefit for patients.” 
  • Fierce Pharma informs us,
    • “With the writing apparently on the wall, PTC Therapeutics has called off its latest bid for FDA approval of its Duchenne muscular dystrophy (DMD) drug Translarna. 
    • “Late Thursday, PTC revealed that it withdrew its FDA application for Translarna in nonsense mutation DMD after receiving feedback on its filing from the regulator. 
    • “FDA shared that based on its review to date, the data in the [New Drug Application] submission are unlikely to meet the Agency’s threshold of substantial evidence of effectiveness to support approval of Translarna,” Matthew Klein, M.D., PTC’s chief executive, explained in a statement. 
    • “PTC is “disappointed that FDA approval cannot be achieved,” Klein said, citing the decades of development work that have gone into the company’s protein restoration therapy. 
    • “In a letter to the U.S. DMD community, PTC cited unresolvable “differences in data interpretation” with the FDA, Pharmaphorum reports.” 
  • and
    • “It’s déjà vu all over again. Just as the kidney disease space becomes increasingly competitive, Novartis has found itself intending to turn a statistical miss into a regulatory win.
    • “Despite the phase 3 Align trial narrowly failing to hit its kidney function endpoint, Novartis announced Friday that it will pursue traditional FDA approval for Vanrafia (atrasentan) in IgA nephropathy (IgAN).” * * *
    • “For its part, Novartis is leaning on a “positive difference” with Vanrafia versus placebo in eGFR change from baseline at Week 136, as well as a “clinically meaningful” improvement for the drug at Week 132, when study treatment ended.” 

From the judicial front,

  • The AHA News reports,
    • “The U.S. District Court for the Eastern District of Texas Feb. 12 vacated a final rule by the Federal Trade Commission that changed premerger notification rules, form and instructions under the Hart-Scott-Rodino Antitrust Improvements Act. The rule had increased reporting requirements on the HSR form. The final rule was challenged by the U.S. Chamber of Commerce in 2024.
    • “First, the Final Rule exceeds the FTC’s statutory authority because the agency has not shown that the Rule’s claimed benefits will ‘reasonably outweigh’ its significant and widespread costs,” Judge Jeremy D. Kernodle wrote in his opinion. “Though the FTC asserts that the Rule will detect illegal mergers and save agency resources, the FTC fails to substantiate these assertions. The Final Rule is therefore not ‘necessary and appropriate,’ and the statute ‘does not authorize [the FTC] to promulgate [the Final Rule].’”
    • “The AHA filed an amicus brief in the case last year, explaining that the changes made by the FTC under the HSR Act were “unnecessary and unlawful.” Key aspects of yesterday’s decision, including the court’s rejection of the FTC’s reliance on a study regarding hospital mergers, were based on arguments made in the AHA’s amicus brief.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old. RSV hospitalizations are highest among infants less than 1 year old. COVID-19 activity is elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country; however, trends vary by region.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP adds,
    • “Six more US children died of influenza last week, for a total of 66 pediatric deaths this respiratory illness season, as flu rates remained moderate to very high in different regions of the country, per the weekly FluView update from the Centers for Disease Control and Prevention (CDC).
    • “Of all pediatric deaths this season, 90% who were eligible for vaccination were unvaccinated. This age-group has been particularly vulnerable, with high-severity illness, while both adults and older adults are currently categorized as having moderate-severity illness. 
    • “The 2024-25 influenza season saw 289 pediatric deaths—the most reported in a non-pandemic flu season since the CDC began tracking child flu deaths in 2004.
    • “COVID-19 rates are still elevated and are growing in some states, but ED visits for the virus are decreasing.”
  • The AHA News tells us,
    • “The South Carolina measles outbreak has grown to 950 cases, the state’s Department of Public Health reported Feb. 13. Of those, 246 cases are under age 5, 611 cases are from age 6-17, 82 cases are age 18 or older, and the ages of 11 cases are unknown. Since Jan. 1, 910 confirmed measles cases nationwide have been reported to the Centers for Disease Control and Prevention. The vaccination status of 94% of cases is classified as unvaccinated or unknown.”
  • The UMN CIDRAP again adds,
  • Radiology Business informs us,
    • “A novel artificial intelligence model could improve the identification of a potentially deadly pregnancy complication that often goes undetected. 
    • “Placenta accreta spectrum happens when the placenta improperly attaches, typically too deeply, to the uterine wall. Due to its potential to trigger life-threatening hemorrhage during or after delivery, it is considered a high-risk complication of pregnancy and is a leading cause of maternal mortality and morbidity. 
    • “Despite the dangers associated with the condition, its presence often (up to half the time) evades detection during pregnancy. With instances of PAS on the rise, there is a critical need for methods of identifying the condition prior to delivery. 
    • “This week, during the Society for Maternal-Fetal Medicine (SMFM) 2026 Pregnancy Meeting, researchers shared new data on a novel AI tool they believe could help improve the diagnosis of PAS. 
    • “Our team is very excited about the potential clinical implications of this model for accurate and timely diagnosis of PAS,” researcher Alexandra L. Hammerquist, MD, a maternal-fetal medicine fellow at Baylor College of Medicine in Houston, said during the presentation. “We are hopeful that its use as a screening tool will help decrease PAS-related maternal morbidity and mortality.”   
  • Fierce Healthcare informs us,
    • “While Generation Z and millennial workers still account for fewer claims than their baby boomer counterparts, claims in these populations are rising fast, according to a new report.
    • “UnitedHealthcare and the Health Action Council (HAC) earlier this month released their annual white paper digging into key trends impacting the employer market and found that the number of claims for lower-aged workers are increasing more quickly than they did for baby boomers.
    • “Between 2023 and 2025, the year-over-year growth rate in claims was nearly double that of baby boomers. The study also found that younger individuals were developing conditions like diabetes or obesity earlier in life and were less likely to be engaged with a primary care provider (PCP), instead frequenting the emergency room.
    • “All of these factors can drive up medical costs for employers in the long term, according to the report.” * * *
    • “For employers or plan sponsors that identify this trend, the challenge is how to best engage this population around their health. One approach, Kurtzweil said, is to try and incentivize them to develop a primary care relationship through education and communication programs that make clear the value of a PCP.
    • “Or, plan sponsors can consider alternative options like on-site clinics or virtual care that can connect people to the healthcare system without necessarily leaning on primary care, he said.”
  • The Health Care Cost Institute lets us know,
    • “Nearly half of adults in the US have high blood pressure or high cholesterol, which are key risk factors of heart disease – the leading cause of death in the US.  HHS estimates about 30 million adults in the US have blood pressure at levels where medication use is recommended but are untreated. The American Heart Association estimates the direct and indirect costs of cardiovascular disease in the US is more than $414B. Commonly used, low-cost medications can effectively treat high blood pressure and high cholesterol and prevent more serious and costly heart-related conditions like heart attack or stroke.” 
  • Medscape adds,
    • “Patients worried about potential side effects of statins can rest easy, according to a new large-scale study: The vast majority of adverse effects listed on statin medications simply never occur.
    • “The study, published in The Lancet, analyzed individual patient data from 154,000 patients in 23 large, randomized controlled trials conducted by the Cholesterol Treatment Trialists’ Collaboration.”
  • Healio points out,
    • “Night shift workers and individuals who regularly achieve fewer than 6 hours of sleep demonstrate an increased risk for osteoarthritis, according to findings published in Arthritis Care & Research. 
    • “We chose to study the associations of shift work and sleep with osteoarthritis because accumulating laboratory evidence had indicated that maintenance of daily circadian rhythms are critical for homeostasis of articular cartilage and other joint tissues,” Elizabeth Yanik, PhD, ScM, assistant professor in the department of orthopedic surgery at Washington University, St. Louis, told Healio. “However, few studies had investigated the relationships between circadian clock disruption, sleep and osteoarthritis risk in humans.”
  • The Wall Street Journal adds,
    • “Attention lapses from sleep deprivation result from the brain’s efforts to clean itself, a process usually occurring during sleep, research suggests.
    • “A study in Nature Neuroscience found sleep-deprived brains experience fluid pulses during wakefulness, causing brief attention reductions.
    • “During these attention lapses, cerebrospinal fluid surges through the brain, and study participants experienced slower reactions and missed cues.”

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

  • The Wall Street Journal reports,
    • “Annual inflation slowed in January, falling more than economists expected, helped by declining prices for gasoline and used vehicles.
    • “Cooler price increases overall are positive news for the economy, easing concerns that the Trump administration’s steep tariffs will lead to broader ongoing inflation. Yet price increases in January for items like computers and washing machines suggest inflation is continuing to weigh on Americans exhausted by price hikes.
    • “Consumer prices rose 2.4% in January from a year earlier, cooler than 2.7% in December and below the 2.5% economists surveyed by The Wall Street Journal had expected. Core prices, which exclude volatile food and energy items, rose 2.5% from a year earlier, in line with expectations.” * * *
    • “Analysts and economists have focused on the rising price of goods as a way to measure tariff impact, but the report also showed higher costs for an array of services, including airline tickets and hospital care. Overall, costs for services rose at their fastest monthly clip in a year, a frustrating data point for economists who have warned that lingering services inflation will be hard to slow.” 
  • Modern Healthcare relates,
    • “Health systems are investing billions of dollars into inpatient facilities, driven by an aging population and increasing demand for specialized care. 
    • “In recent years, providers have largely focused their investing on extensive outpatient projects. They also face ongoing cost pressures and regulatory uncertainty.
    • “Still, several are looking to add to their inpatient footprint. 
    • “Mark Pascaris, senior director at credit ratings agency Fitch Ratings, said demand for inpatient projects is particularly strong in competitive markets with growing populations.
    • “I think we have and will continue to see plenty of big-ticket hospital constructions,” Pascaris said. “We can’t ignore the inpatient footprint. The [COVID-19] pandemic taught all of us that we still need ICUs. We still need inpatient surgery suites.” 
  • Per Beckers Payer Issues,
    • “Humana is in talks with Sarasota, Fla.-based MaxHealth — a primary care network and platform focused on adults and seniors — regarding an acquisition, Bloomberg reported Feb. 12.
    • “According to Bloomberg sources, MaxHealth, owned by private equity firm Arsenal Capital Partners’ Best Value Healthcare, could have been valued at about $1 billion.
    • “Humana President and CEO Jim Rechtin previously said the company is looking to expand its primary care footprint.
    • “We also hope to soon announce a strategic acquisition in the primary care space,” Mr. Rechtin saidon a Feb. 11 earnings call.” 
  • The Employee Benefits Research Institute prepared a report titled “Cell and Gene Therapies in Employment-Based Health Insurance: Financing the High-Cost, High-Impact Future.” Check it out.
  • MedCity News considers “From Claims Payer to Care Partner: What AI Really Changes in Health Insurance, and What It Doesn’t.”
    • “AI can help health plans reduce friction, speed revenue-cycle throughput, and improve member experience, but only when it is deployed with strong data discipline, modern integration patterns, and a governance model that treats AI as “augmented intelligence,” meaning powerful, assistive, and accountable.”
  • The Wall Street Journal notes,
    • “In one experiment, offering human contact to loan applicants during the approval process made them much more likely to eventually accept a loan if offered.
    • “A study found that providing access to a human, even if unused, boosts customer satisfaction and confidence in sensitive online transactions.
    • “Only about 10% of customers offered human assistance actually use it, suggesting the cost of providing the option is lower than perceived.”
  • Fierce Pharma points out,
    • “Determined to avoid a repeat of the supply shortfalls that plagued early GLP-1 rollouts for obesity, Eli Lilly has amassed a sizable store of its oral weight loss candidate orforglipron. 
    • “Specifically, Lilly had secured “pre-launch inventories” worth $1.5 billion as of Dec. 31, with most of that supply tied to orforglipron, the company said in a securities filing this week. 
    • “The update on Lilly’s pending launch inventory comes after the Indianapolis drugmaker said last February that it had built up nearly $550 million in early inventory that was again primarily related to orforglipron.” 
  • BioPharma Dive informs us,
    • “Moderna reported better-than-expected fourth quarter sales and affirmed revenue growth estimates for 2026 despite soft demand for its COVID-19 vaccine and recent, high-profile pushback from the Food and Drug Administration.
    • “The biotechnology company said Friday it recorded revenue of $678 million over the final three months of last year and $1.9 billion for all of 2025, figures that came at the higher end of a projected forecast from November. U.S. sales more than halved between the third and fourth quarters, but still made up more than 60% of Moderna’s full-year revenue, in part because of the successful launch of the COVID shot mNEXSPIKE and a strong U.S. retail COVID vaccine market.”
  • Per MedTech Dive,
    • “Dexcom is watching for expanded Medicare coverage of its continuous glucose monitors to people with Type 2 diabetes who don’t take insulin. 
    • “New CEO Jake Leach told investors on Thursday that the company has been “sitting here waiting for a coverage decision” from the Centers for Medicare and Medicaid Services. Dexcom expects CMS to propose a coverage expansion in the first half of 2026, BTIG analyst Marie Thibault wrote in a note to clients Thursday. 
    • “Dexcom started to see commercial coverage unlock for Type 2, non-insulin users toward the end of last year, Leach said. He expects broader Medicare coverage for that group would allow nearly 12 million people to access CGMs. 
    • “In the meantime, the American Diabetes Association updated its guidelines last year to recommend clinicians consider using CGMs for Type 2 diabetes when patients are taking glucose-lowering medications other than insulin. Leach said that real world data the company has been generating supports that decision, and that Dexcom has launched a registry for non-insulin users.”

Thursday report

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

Happy Lincoln’s Birthday

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Department of Homeland Security is on the verge of a shutdown after Senate Democrats voted to block a bill to fund the agency, saying negotiations with Republicans to put new restrictions on immigration enforcement hadn’t made enough progress.
    • “A bill to fund DHS through September failed to advance with 52 in favor and 47 opposed, short of the 60 votes required. Republicans control the Senate 53-47 but need Democratic support to pass most bills due to the longstanding filibuster rule.
    • “Democratic Sen. John Fetterman of Pennsylvania voted with Republicans to advance the bill, while Senate Majority Leader John Thune (R., S.D.) switched his vote from yes to no to preserve his ability to bring the bill up again. Sen. Mitch McConnell (R., Ky.) was absent.
    • “DHS oversees Immigration and Customs Enforcement and Customs and Border Protection as well as the Federal Emergency Management Agency, the Transportation Security Administration and the U.S. Coast Guard. While the failed vote sets the stage for funding to lapse at DHS for at least a week, there isn’t expected to be any significant impact on border enforcement from the shutdown.”
  • The Washington Post adds,
    • “The Senate is not expected to hold any more votes before a shutdown starts at 12:01 a.m. Eastern time on Saturday, and many senators were set to leave town Thursday to travel to the Munich Security Conference. Schumer and Thune have said they are prepared to bring senators back early if a deal comes together.” * * *
    • “This shutdown would affect only DHS — but it would not shutter U.S. Immigration and Customs Enforcement or Customs and Border Protection, because Republicans sent those agencies tens of billions of dollars in additional funding last year that would allow them to continue to operate.
    • “Instead, the brunt of a shutdown would fall on the Transportation Security Administration, the Federal Emergency Management Agency, the Coast Guard and other agencies within DHS. It would affect about 13 percent of the federal civilian workforce, most of whom would be forced to work without pay, according to data from DHS and the Office of Personnel Management.”
  • The Wall Street Journal tells us
    • “The White House and Health Secretary Robert F. Kennedy Jr. have shaken up the top ranks at his department, a move meant to install more disciplined messengers and smoother operations ahead of the midterm elections.
    • “Kennedy and White House officials tapped Chris Klomp, the head of Medicare and a former healthcare executive, to lead the department as its No. 2 under Kennedy, administration officials said. Klomp will have responsibility for operations and messaging, and he will be aided by at least three other agency lieutenants to take senior counselor roles under him, the officials said.
    • “We’re structuring in such a way that we can move faster and we can make sure the quality is uniform,” Klomp said in an interview.” * * *
    • “The three other senior advisers tapped to help Klomp include John Brooks, who currently heads policy at the Centers for Medicare and Medicaid Services; Grace Graham, who leads the Food and Drug Administration’s policy office; and Kyle Diamantas, who heads FDA’s food division. Brooks will oversee CMS matters, while Graham and Diamantas will have roles managing the FDA.”
  • Beckers Payer Issues informs us,
    • “Fourteen health insurers have voluntarily committed to CMS’ “Advancing Chronic Care with Effective, Scalable Solutions” model, according to a Feb. 12 CMS news release shared with Becker’s.
    • “The insurers that are on board will work toward achieving alignment with the model by 2028. The plans represent 165 million Americans.
    • “With a decade-long evaluation period beginning in July, ACCESS will explore whether linking payments to clinical outcomes can facilitate technology in chronic disease management, focusing on Medicare beneficiaries. Targeted conditions include high blood pressure, diabetes, chronic musculoskeletal pain and depression. The agency began accepting applications, which are due in April, on Jan. 12.
    • “The FDA’s “Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot” will operate in conjunction with ACCESS, allowing expanded availability of relevant devices.”
  • The Internal Revenue Service issued a draft of Publication 969 Health Savings Accounts and Other Tax-Favored Health Plans For use in preparing 2025 Returns.
  • The American Hospital Association News lets us know,
    • “A bipartisan letter supported by the AHA was sent by members of Congress Feb. 11 to the Department of Homeland Security, urging the agency to grant health care workers an exemption from the $100,000 filing fee for H-1B visas. The letter, led by Reps. Yvette D. Clarke, D-N.Y., and Michael Lawler, R-N.Y., was signed by 100 lawmakers. “Imposing a $100,000 fee for new H-1B visa petitions will exacerbate hospitals’ existing staffing challenges and could push chronically underfunded hospitals to their financial brink,” the legislators wrote. “If these hospitals cannot petition for new H-1B visas to address their staffing needs without also having to pay this fee, it will further damage their financial viability. Critically needed open positions will simply go unfilled, leaving rural and high-poverty urban areas without adequate access to care.”
  • and
    • “The Administration for Strategic Preparedness and Response has launched a $100 million competition to support the development of antiviral drug therapies targeting viruses in the Togaviridae and Flaviviridae families, such as dengue, Zika, West Nile and Chikungunya. The initiative, called the Small Molecule Approaches for Rapid and Robust Treatment Prize, will be coordinated by ASPR’s Biomedical Advanced Research and Development Authority. BARDA plans to include input from experts in drug development, virology, artificial intelligence, medicinal chemistry and public health for the program. A series of virtual information sessions will be held in the coming weeks on the initiative, which has a May 11 application deadline.” 
  • Federal News Radio interviews Tammy Flanagan about federal employee retirement benefits.
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC), together with the Office of Personnel Management (OPM), today provided federal agencies with a joint technical assistance document addressing telework as a reasonable accommodation for federal employees with disabilities.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “In an hour-long meeting in January, Food and Drug Administration career staff laid out their objections to a plan to block a new flu shot from vaccine maker Moderna. They argued that refusing to even consider the vaccine was the wrong approach to address any concerns about the product.
    • “Vinay Prasad, the head of the FDA vaccine and biologics division, overruled them—despite the agency earlier signing off on Moderna’s approach to studying the shot. Prasad told Moderna earlier this month he wouldn’t review its flu application, arguing that its clinical trial was inadequate.
    • “The Moderna decision is part of a pattern of regulatory U-turns and overruling of FDA staff by Prasad, a Covid-vaccine critic elevated by FDA Commissioner Marty Makaryand Health Secretary Robert F. Kennedy Jr. At least nine companies, many of them focused on rare or hard-to-treat diseases, have said Prasad’s team has surprised them in recent months with rapid shifts in its decisions, in some cases rejecting their products after previously blessing their approaches.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue.”
  • and
    • “The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the “boxed warning,” the agency’s most prominent safety-related warning.”

From the judicial front,

  • Fierce Pharma reports,
    • “In response to last month’s list of the 15 drugs chosen by the Centers for Medicare & Medicaid Services (CMS) for upcoming price cuts under the Inflation Reduction Act (IRA), AbbVie is the latest to join the flood of industry litigation over the law.
    • “While AbbVie’s lawsuit contends that the CMS pricing negotiations mandated for Botox step on the company’s constitutional rights—a common thread woven into much of the industry’s legal complaints about the program—the Illinois-based drugmaker also takes a unique position that specifically relates to the formulation of its offering.”
    • “When the IRA was signed into law by former President Joseph Biden in 2022, the law made clear that only certain products are eligible to make the list of drugs that will go through negotiations to determine maximum fair prices paid under Medicare. The IRA specifically excludes “low-spend drugs,” or those with Medicare spending of less than $200 million, certain orphan rare disease drugs and plasma-derived products. 
    • “AbbVie is hedging its argument around the IRA’s “express statutory exclusions” for plasma-derived products, it said in its complaint, which was filed in a Washington D.C. District Court on Feb. 11 and names the Department of Health and Human Services (HHS), CMS and their respective leaders, Robert F. Kennedy Jr. and Mehmet Oz, M.D.”

From the public health, medical and Rx research front,

  • Cardiovascular Business reports,
    • “Interest in lipoprotein(a), or Lp(a), is on the rise thanks to mounting evidence that the genetically inherited lipid particle may be a key missing link in unexplained heart attacks and strokes. While current treatments are limited, experts say that will likely change in the near future when new drugs begin to enter the market.
    • :Nathaniel Lebowitz, MD, who leads preventive cardiology at Hackensack University Medical Center and serves as an assistant professor of internal medicine at Hackensack Meridian School of Medicine, has spent two decades studying this biomarker. He is now part of the American Heart Association (AHA) Lp(a) Discovery Project, a national initiative aimed at expanding physician and patient awareness as new therapies move closer to market. Lebowitz spoke with Cardiovascular Business at length about this important topic.
    • “Lp(a) is a major, major killer. And most of the population, and even most doctors, don’t know the exact degree of how dangerous it really is,” he explained.
    • “Lebowitz noted that Lp(a) is often responsible when patients suffer cardiovascular events despite not showing any of the normal warning signs.
    • “When somebody who you wouldn’t expect to have a stroke or a heart attack has one and does not have traditional risk factors to speak of, check Lp(a), because it will be positive,” he said.
    • “Lp(a) is genetic and present in about 20% of the general population. Guidelines from the AHA, American College of Cardiology and National Lipid Association now emphasize screening in individuals with a family history of premature heart disease, as well as cascade screening of first-degree relatives when Lp(a) is identified. Levels typically do not fluctuate significantly, so testing once is believed to be generally sufficient.
    • “I consider it a risk elevator. It’s a risk multiplier,” Lebowitz said. “So if somebody is considered low risk for cardiovascular disease, but they have Lp(a) now, I would consider them intermediate risk. If they’re intermediate risk, but they have Lp(a), I would now consider them high risk and treatment should ensue accordingly.”
    • “Currently, there are no approved therapies specifically targeting Lp(a), but that may soon change. Several investigational agents are in late-stage clinical trials, including small interfering RNA (siRNA) therapies designed to silence the gene responsible for producing Lp(a).”
  • The New York Times provides a look at what alchohol does to your body.
    • “Dry January has come and gone, but Americans’ relationship with drinking is undergoing a more lasting change. According to one recent poll, just 54 percent of U.S. adults said they consume alcohol, the smallest percentage in nearly 90 years of data collection. That may be because more people are taking alcohol’s negative health consequences seriously.
    • “Drinking alcohol can have profound effects on the brain and body. In the moment, some of those effects can be pleasurable. But in the long term, especially when it’s consumed in large quantities, alcohol can cause serious health harms.”
  • and tells us,
    • “Fertility experts know that the more eggs retrieved from a woman, the better the chances that one of them will lead to a viable embryo that will result in the birth of a baby.
    • “Now, a new study suggests something startling, even to many in the field: the conventional method of searching for eggs often fails to find all of them, and a new technology that automates the process may significantly increase the number recovered.
    • Using the conventional method, embryologists use high-powered microscopes to search the follicular fluid extracted from women in fertility clinics. The fluid is then discarded. The study, published in Nature Medicine on Thursday, reported that a device that uses microfluidic technology to sift through follicular fluid found additional eggs for more than half of the patients.
    • “It’s very, very surprising,” said Dr. Mitchell Rosen, who directs the reproductive laboratories at the University of California, San Francisco and was not involved in the study. “They were finding eggs that we wouldn’t otherwise have had the potential to use.”
  • MedPage Today informs us,
    • “Receiving an mRNA SARS-CoV-2 vaccine during or shortly before pregnancy had no impact on kids’ neurodevelopmental outcomes, a multicenter prospective observational study found.
    • “Kids between ages 18 and 30 months scored similarly on the Ages & Stages Questionnaire, 3rd Edition (ASQ-3) (adjusted median difference -3.4, 95% CI -9.7 to 3.0) as well as in each of the five specific ASQ-3 domains, reported George Saade, MD, of Eastern Virginia Medical School in Norfolk, Virginia, during a presentation at the Society for Maternal-Fetal Medicine (SMFM) annual meeting.
    • “Scores on other neurodevelopment assessments that evaluated emotional and behavioral problems, risk for autism spectrum disorder, and temperament were also similar between groups.
    • “We conclude that the primary neurodevelopmental outcome was equivalent between children of mothers who received and did not receive mRNA SARS-CoV-2 vaccination during or immediately prior to pregnancy, and there was no association with secondary neurodevelopmental outcomes,” Saade said during his presentation.
    • “Our results provide reassurance regarding the safety of mRNA SARS-CoV-2 vaccination and pregnancy,” he added.
    • “Indeed, much research has found no link between COVID vaccination in pregnancy and adverse outcomes for children, including at least two studies showing no increase in birth defects.”
  • BioPharma Dive observes,
    • “An experimental medicine from BridgeBio Pharma, the San Francisco-area biotechnology company, has succeeded in a late-stage clinical trialas a treatment for the most common type of dwarfism, results which could tee up an approval and greater competition for two other closely watched therapies.
    • “The trial enrolled around 110 children with achondroplasia, who, over a main treatment period of a year, were given either a placebo or BridgeBio’s drug, called infigratinib. On Thursday, BridgeBio announced that those in the drug arm were growing taller faster. Depending on the measure, this “annualized height velocity” was, on average, between 1.74 and 2.1 centimeters greater per year than what researchers observed in the control group.
    • “Not only did infigratinib meet the trial’s central goal, it also scored so well on a couple other height and growth tests that BridgeBio said it set records for a randomized study of achondroplasia patients. The drug was well tolerated, too, as no serious adverse events were tied to it. No one dropped out of the trial because of side effects either. BridgeBio did disclose three cases of patients having abnormally high levels of phosphate in their blood, but all were mild, transient, asymptomatic, and didn’t require the dose given to be changed or stopped.”
  • Beckers Hospital Review notes,
    • “The number of active drug shortages has declined sharply since June, according to the FDA’s drug shortage database.
    • “Eighty drugs were in shortage as of Feb. 12, down from 194 in mid-June.
    • “The decline reflects updates to the FDA’s database, which is modified daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
    • The article also points out “12 recent drug shortages, according to the FDA database.”

From the U.S. healthcare business front,

  • Per an Institute of Clinical and Economic Review news release,
    • “Institute for Clinical and Economic Review Publishes Final Evidence Report on Medication for Smoking Cessation
    • “Independent appraisal committee votes reflect a net health benefit for cytisinicline alone, but uncertainty when compared to varenicline; Manufacturer setting a price for cytisinicline to align with value would help ensure public health goals for smoking cessation are met.”
    • Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • Beckers Payer Issues reports,
    • “Most of the country’s largest insurers reported year-over-year increases in medical cost ratios in 2025.
    • “Centene reported the highest medical loss ratio at 91.9%, driven by higher marketplace medical costs, Medicaid cost pressures in behavioral health and home health, and program changes in the Medicare prescription drug plan business.”
    • The article provides the largest insurers MLRs for 2023, 2025 and 2025.
  • Healthcare Dive relates,
    • “Hospital operator Tenet Healthcare expects the expiration of more generous Affordable Care Act subsidies to lower its earnings growth this year by about $250 million.
    • “Still, Tenet’s expected loss is smaller than those of some of its peers, including HCA Healthcare, which last month said it expects to lose up to $900 million from the lapse of the enhanced tax credits in 2026.
    • “Excluding the ACA headwind and the impact of some Medicaid state supplemental payments, Tenet anticipates it will grow adjusted earnings before taxes and other non-operating expenses by about 10% this year compared to 2025, executives said on a Wednesday call with investors.”
  • BioPharma Dive tells us,
    • “Sanofi on Thursday announced the ouster of CEO Paul Hudson after a six-year tenure that included a major transformation of the French drugmaker and the rise of Dupixent into one of the world’s best-selling medicines.
    • “Hudson will be replaced by current Merck KGaA CEO Belén Garijo, who is leaving her post at the German company at the end of April as part of a planned transition. Olivier Charmeil, executive vice president for general medicines, will serve as interim CEO after Hudson’s departure at the close of business on Feb. 17, Sanofi said.
    • “Belén Garijo will bring an increased rigor to the implementation of Sanofi’s strategy and accelerate the preparation of the group’s future,” Sanofi said. “Her priority will be to strengthen the productivity, governance and innovation capacity of research & development.”
  • Fierce Healthcare informs us,
    • “Maven Clinic, a virtual women’s and family health provider, is teaming up with health tech company Color Health to support family building after a cancer diagnosis. 
    • “The partnership’s goal is to expand access to oncofertility care, helping patients of childbearing age going through the cancer journey to understand and preserve their fertility options. Members will receive access to oncologists, dietitians, mental health providers, fertility preservation specialists and care advocates. The services will be available to cancer patients through employers and payers to start. 
    • “Both of us have seen the attention being paid by employers to what it really looks like for their team members going through a cancer diagnosis, because it’s happening at such a rapid clip now,” Caroline Savello, president at Color, told Fierce Healthcare. A quarter of Color patients are between the ages of 18 and 45.”
  • and
    • “Specialty care company Lantern revealed it will expand its cancer care navigation platform through a new partnership with AccessHope.
    • “Through the partnership, Lantern’s platform will now include expert review at each point in a patient’s care journey, preventing misdiagnoses and ensuring treatments meet clinical guidelines. Reviews will be conducted by experts at National Cancer Institute (NCI)-designated cancer centers, according to the announcement.
    • “Lantern said the reviews will be available for both adult and pediatric cancers as well as solid tumors and blood-based disease.
    • “Dickon Waterfield, president of Lantern, told Fierce Healthcare that the “beauty of this partnership” lies in the ability to allow people to seek care in their local communities while also providing them supports at the standard of an NCI-designated facility.”

Midweek report

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

From Washington, DC,

  • Roll Call reports,
    • “Republicans and Democrats sparred Wednesday on the potential real-world harms of a partial shutdown for the Department of Homeland Security, as Congress marched toward a funding deadline for the agency amid a dispute over immigration enforcement policies.
    • “The House Homeland Security Appropriations Subcommittee held a hearing with officials from five national security and emergency management agencies to highlight what would happen if a continuing resolution expires Saturday without further action from Congress.”
  • and
    • “Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. 
    • “At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries.
    • “But Guthrie stressed that further changes could be forthcoming.
    • “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.”
    • “Rep. Morgan Griffith, R-Va., chair of the Health Subcommittee, said after the hearing that he hopes to mark up affordability legislation before Memorial Day, but acknowledged the appetite for bipartisan cooperation will be “tough” given the political climate.” 
  • Beckers Payer Issues adds,
    • “Sens. Elizabeth Warren, D-Mass., and Josh Hawley, R-Mo., have introduced legislation that would ban health insurers and pharmacy benefit managers from owning medical providers, and would force companies in violation to divest within one year of the bill’s enactment.
    • :The “Break Up Big Medicine Act” would also prohibit a parent company of a prescription drug or medical device wholesaler from owning a medical provider or management services organization.”
  • The American Hospital Association tells us,
    • “The Senate Special Committee on Aging held a hearing Feb. 11 on issues impacting physician burnout. The AHA provided a statement for the hearing and urged Congress to pass legislation to address burnout, including the Improving Seniors’ Timely Access to Care Act (H.R. 3514/S. 1816), legislation that would streamline prior authorization requirements under Medicare Advantage plans by making them simpler and more uniform, and the Save Healthcare Workers Act (H.R. 3178/S. 1600), a bill that would make it a federal crime to assault a hospital employee. The AHA also urged Congress to pass the Resident Physician Shortage Reduction Act of 2025 (H.R. 3890/S. 2439), which would add 14,000 Medicare-funded residency positions over seven years.”
  • Per OPM news releases,
    • [On February 10, 2026], the US Office of Personnel Management (OPM) convened senior administration officials, federal agency leaders, and industry executives at the White House for a US Tech Force (Tech Force) roundtable focused on strengthening the federal government’s technology workforce and accelerating innovation across agencies.
  • and
    • “US Office of Personnel Management (OPM) Director Scott Kupor appeared on Fox Business to discuss the administration’s launch of the U.S. Tech Force, a new initiative aimed at strengthening the federal workforce with top technical talent and modernizing critical government systems.” You can watch the Director’s appearance here.
  • Govexec discusses the tax implications of making Roth IRA conversions in the Thrift Savings Plan.
    • “Beginning Jan. 28, the Thrift Savings Plan now allows participants to convert traditional (pre-tax) balances into Roth (after-tax) balances inside the TSP itself. This long-awaited change gives federal employees and retirees more flexibility over how and when they pay taxes on retirement savings.
    • “While the mechanics of the change are straightforward, the implications are not. A Roth in-plan conversion is a tax event and not just a retirement planning decision. Once it is made, it cannot be reversed. Knowing this beforehand helps you choose effective planning tools and avoid costly errors.”
  • Per an HHS news release,
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “ASTP/ONC released the draft USCDI v7 on January 29, 2026, proposing 29 new data elements and one significantly revised element to strengthen nationwide interoperability. Draft USCDI v7 expands standardized health data to support more efficient adverse event reporting, nutrition information exchange, and quality improvement, ultimately modernizing how health information is used across the entire health care system to Make America Healthy Again.”
    • “In the coming days, ASTP/ONC will launch the EHIgnite Challenge, a two-phase prize competition to improve the usability, readability, and actionability of single-patient electronic health information (EHI) exports. The EHIgnite Challenge will catalyze the development of tools and workflows, focused on the application of AI, that transform raw EHI into clear, usable information to better support care transitions, provider onboarding, and patient understanding and engagement. Awards will support both concept development and prototype solutions through 2027.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For all its success across a wide range of cancer types, Merck’s PD-1 superstar Keytruda has never been able to crack the code for one of the toughest-to-treat indications in oncology—ovarian cancer.
    • “But now, 13 years after the FDA initially blessed it for skin cancer, the U.S. regulator has approved Keytruda as a second- or third-line treatment for patients with a certain type of ovarian cancer.
    • “With the green light, Keytruda becomes the first immune checkpoint inhibitor approved for this indication. 
    • “Keytruda is to be used in combination with the chemotherapy paclitaxel and with or without Roche’s targeted cancer therapy Avastin. The endorsement covers those with platinum-resistant recurrent ovarian, fallopian tube or primary peritoneal carcinoma with PD-L1-positive tumors. 
    • “The nod also covers infused Keytruda and its subcutaneous version, Keytruda Qlex, which the FDA blessed five months ago.” 

From the public health and medical / Rx resarch front,

  • STAT News reports,
    • “Food fights pitting low-carbohydrate diets against low-fat diets are off the mark when they aim at heart health, a large new study suggests. To reduce heart disease risk, it’s the quality, not the quantity, of those carbs or fats that matter. Diets high in plant-based foods, whole grains, and unsaturated fats led to better heart health, the researchers found. Low-fat dairy also got a nod when part of a diet featuring whole grains, vegetables, and fruits.
    • “Not all carbs are created alike; nor are all fats. Whole grains, fruits, vegetables, nuts, legumes, and olive oil are associated with lower risk of coronary heart disease (CHD), whether they contain carbohydrates or fats. But diets high in refined carbohydrates and animal proteins and fats were associated with a higher risk of heart disease, according to the new study, published Wednesday in the Journal of the American College of Cardiology.” 
  • MedPage Today relates,
    • “The CDC excludes homicide, suicide, and overdose in defining “maternal mortality,” instead focusing on more medical causes.
    • “An analysis of 2018-2023 data showed that drug overdoses, homicides, and suicides accounted for more than a quarter of all deaths among pregnant and postpartum women.
    • “Violence and overdose accounted for 2,018 deaths, while cardiovascular causes, hypertension, infection, and hemorrhage together accounted for 2,141 deaths [over the period 2018-2023].” * * *
    • “Maeve Wallace, PhD, MPH, of the Mel & Enid Zuckerman College of Public Health at the University of Arizona in Tucson, told MedPage Today that the results were not surprising.
    • “Research dating back decades finds that rates of violent death exceed obstetrical causes of death for pregnant women,” Wallace said. “What is disheartening is that this continues to be the case.”
    • “This analysis “can help policymakers concerned with maternal health understand pregnancy as a dangerous condition,” and can encourage policy-level solutions to promote women and girls’ health and safety, she added.”
  • and
    • “A meta-meta-analysis of randomized trials showed exercise reduced depression and anxiety symptoms.
    • “Group aerobic exercise appeared to be most effective for depression, while exercise of shorter duration and lower intensity was most associated with reductions in anxiety symptoms.
    • “The researchers concluded that tailored exercise programs are an “accessible and cost-effective” treatment option for depression and anxiety.”
  • Healio informs us,
    • “Statin use had a statistically significant protective effect against acute asthma exacerbations in mild asthma among Black adults and adults with obesity, according to data published in Annals of Allergy, Asthma & Immunology. 
    • “The pleiotropic effects of statins may extend beyond cholesterol control due to their anti-inflammatory and immunomodulatory properties, prompting interest in their potential use for chronic airway diseases, William Crawford, MD, physician with the department of allergy, Kaiser Permanente Southern California, and colleagues wrote.
    • “But mixed results in prior research including beneficial and null effects in asthma outcomes indicate that determining the patient subgroups that may benefit most from treatment is vital in determining the role that statins may have in asthma management.” 
  • The American Journal of Managed Care observes,
    • “More than half of patients with long-term conditions (LTCs) surveyed said they preferred a remote consult vs an in-person visit with their referring physician, particularly for discussion of results and medication renewal, according to a new study
       published in JAMA Network Open.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The U.S. economy added 130,000 jobs in January, its strongest growth in over a year, and a sign that the labor market may be shaking off its recent stagnation.
    • “January’s robust gains surprised forecasters, blowing far past consensus expectations, while solidifying expectations the Federal Reserve will keep rates on hold for the foreseeable future. The unemployment rate dipped to 4.3% from 4.4% in December, the Labor Department said Wednesday. And workers’ wages rose.
    • “The gains were highly concentrated in healthcare and social-assistance fields, which includes jobs like home health aides and residential care workers. Such jobs tend to grow regardless of the economy’s health and have long been an engine of U.S. job growth.”
  • Fierce Healthcare relates,
    • “Humana CEO Jim Rechtin acknowledged the noise around the latest Medicare Advantage rate notice and said that while the flat proposal is a concern, the company will continue to push forward on its performance improvements.
    • “He said that part of the challenge for policymakers, regardless of political alignment, is managing the program as it “sits at the intersection of U.S. fiscal pressures and a program that is incredibly popular with seniors.”
    • “Every administration wrestles with how to balance these two forces,” Rechtin said.
    • “We are committed to always protecting our consumers the best we can, and we are very aware that we must do that within the constraints of the annual funding environment,” he continued. “If that funding environment cannot fully support our benefit structure, then we will adapt as we have in the past.” * * *
    • “Humana reported a $796 million loss in the fourth quarter of 2025, with its losses growing year over year as increased utilization continues to drag Medicare Advantage (MA) plans.
    • “By comparison, Humana reported a $693 billion loss in the fourth quarter of 2024. The company did post a profit for the full year of $1.2 billion, flat from the company’s $1.2 billion haul in 2024.”
  • and
    • “Hinge Health’s shares were up 13% in after-hours trading Tuesday after the digital health company reported a strong fourth quarter and a bright outlook for 2026.
    • “The digital musculoskeletal (MSK) care provider, which went public in late May, brought in fourth-quarter revenue of $171 million, up 46% from the same period a year ago and easily topping Wall Street analyst estimate of $155 million for fourth-quarter revenue. The company posted fourth-quarter adjusted earnings of 49 cents per share, significantly exceeding analyst estimates of 14 cents per share. Hinge Health’s non-GAAP income from operations increased 124% to $48 million during quarter.
    • “Free cash flow for the quarter was $61.5 million, representing a free cash flow margin of 36%.
    • “The company’s full-year 2025 revenue jumped 51% year over year to reach $588 million compared to revenue of $390 revenue in 2024, according to its fourth-quarter and full-year financial results.” 
  • KFF lets us know,
    • “National spending on health has increased rapidly over time—rising to $5.3 trillion and 18% of GDP in 2024—and is projected to continue to do so into the future. Growth in health spending contributes to higher costs for families, employers, Medicare, Medicaid, and other payers. In 2025, average annual premiums for employer-sponsored family coverage reached $26,993, with workers paying $6,850 for their coverage, according to KFF’s annual survey of employers.  Hospital care accounted for nearly one-third of national health expenditures in 2024, and more than doubled in nominal terms over the preceding two decades, making hospitals a major driver of health spending growth over time.” * * *
    • “National health expenditures increased by $692 billion between 2022 and 2024, from $4.6 trillion to $5.3 trillion. During this period, spending on hospital care alone accounted for $277 billion of spending growth, or 40% of the total increase in national health spending (Figure 1). The large contribution of hospital care to overall health spending growth reflects the fact that hospital spending accounted for nearly a third of national health expenditures in 2022 (30%) and grew more quickly than national health expenditures overall in both 2023 (10.6% versus 7.4%) and 2024 (8.9% versus 7.2%).”
    • FEHBlog note — Hospitals and health systems are not included in the Break Up Big Medicine bill discussed above.
  • Beckers Hospital Review tells us,
    • “Dallas-based Tenet Healthcare reported $21.3 billion in revenue in 2025, up from $20.7 billion in 2024, as the system posted strong fourth-quarter results and outlined a positive outlook for 2026. For the fourth quarter, Tenet reported net operating revenue of $5.5 billion, compared to $5.1 billion during the same period in 2024.
    • “2025 extended Tenet’s track record of strong revenue growth, disciplined operations, improved margins and robust free cash flow generation,” Tenet Chair and CEO Saum Sutaria, MD, said in a Feb. 11 news release. “We see continued demand for acute care and ambulatory surgical services in our markets and are confident in our ability to execute on our strategy and achieve our full-year 2026 expectations.”
  • and
    • “There are 417 rural hospitals that are vulnerable to closure, according to a Feb. 10 report from Chartis, a healthcare advisory services firm. 
    • “Chartis’ Rural Hospital Vulnerability Index assesses more than a dozen indicators to identify which are statistically significant for determining the likelihood of closure.
    • “The number of overall rural hospitals vulnerable is down from 432 last year, but Chartis said there are “notable shifts at the state level.” In Tennessee, the percentage of vulnerable hospitals increased from 44% to 61%. In South Dakota, the percentage increased from 28% to 42%. Mississippi, which Chartis said has long been a “weak spot in the rural health safety net,” saw an improvement from 49% to 42%. Kansas also saw an improvement from 47% to 44%. 
    • “”Chartis’ analysis found that 17 states have 10 or more rural hospitals vulnerable to closure this year. Texas has the most with 50, followed by Kansas (44), Tennessee (27), Georgia (25), and Mississippi (24). These states are receiving a combined $1.1 billion in the first round of CMS’ Rural Health Transformation Fund initiative.”  
  • BioPharma Dive informs us,
    • “Shares of Gilead Sciences slid after the stock market closed Tuesday in spite of a fresh earnings report in which the company’s top products beat Wall Street forecasts.
    • “Gilead recorded $7.9 billion in product sales over the final three months of 2025, a 5% increase from the same period a year prior. Brian Abrahams, an analyst at RBC Capital Markets, called it a “strong commercial quarter” with “major beats” in Gilead’s HIV business, which was up 6% year-over-year.
    • “Biktarvy, a three-in-one pill for HIV treatment, and Descovy, a daily tablet often used to stave off infections from the virus, respectively brought in $4 billion and $819 million during the quarter. That’s higher than the roughly $3.84 billion and $720 million the average analyst had penciled in, according to Abrahams.”
  • MedTech Dive notes,
    • “Edwards said study data supporting earlier use of its Sapien heart valves to treat patients who have severe aortic stenosis without symptoms is changing clinical practice and helping to accelerate sales of the devices.
    • “The company on Tuesday posted a second consecutive quarter of double-digit sales growth in its transcatheter aortic valve replacement business.
    • “CEO Bernard Zovighian said momentum is coming from long-term data presented last fall confirming the durability of the Sapien valves and the “practice-changing” EARLY TAVR trial results that showed asymptomatic patients who had the procedure fared better than those who remained under clinical surveillance alone. Edwards is the only TAVR system with asymptomatic approval.”

Weekend update

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

Happy Super Bowl Sunday!

  • The House Energy Commerce Committee health subcommittee holds a hearing on February 11 with Pharma and PBM executives.
  • Fierce Healthcare adds,
    • “In the $1.2 trillion budget package signed Tuesday, a little-known healthcare provision was reauthorized that will allow millions of people on Medicare to access diabetes prevention education online. 
    • “As part of the budget package, Congress passed the PREVENT DIABETES Act, which extends the ability for digital health companies (virtual suppliers) to participate in the Medicare Diabetes Prevention Program (MDPP) through the end of 2029. 
    • “Medicare Part B patients who are at risk for Type 2 diabetes can participate in the program for free, if they meet certain clinical thresholds for weight, blood pressure or blood glucose. The program lasts for a year and consists of 22 sessions on lifestyle changes to prevent diabetes. 
    • “Since the COVID-19 pandemic, virtual providers like Omada Health, 9am Health and Amwell have entered the business on temporary authority, much like other Medicare telehealth services.” 
  • Under the budget package, the Homeland Security appropriations bill remains under a continuing resolution which expires on February 13.
  • Roll Call lets us know,
    • “With no signs of tangible progress in negotiations over changes to immigration enforcement policies, the main question may be whether House members and senators can muster the votes needed for another short-term funding extension just for DHS.
    • “Both chambers of Congress are expected to be on recess next week for Presidents Day. The holiday weekend overlaps with the annual Munich Security Conference, which runs Feb. 13-15 and typically attracts a large congressional delegation.
    • “Senate Majority Leader John Thune, R-S.D., who is not traveling to Munich this week, suggested the Senate may need to be in session if the Homeland Security funding is not resolved.”

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “Hims & Hers has abandoned plans to sell a compounded version of Novo Nordisk’s weight loss pill following backlash from U.S. regulators and the threat of a federal investigation. 
    • “In a short statement posted on the social media platform X Saturday, Hims said that, after “constructive conversations with stakeholders across the industry,” it “decided to stop offering access” to the treatment. “We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.” 
    • “The sudden turn quickly ends, for now, plans by the telehealth company to launch a copycat form of Novo’s “Wegovy” pill. Hims had announced those plans on Thursday and, in doing so, quickly drew legal threats from Novo as well as swift action from the Food and Drug Administration.” 

From the public health and medical / Rx research front,

  • Clinical Advisor reports,
    • “Measles is now extending beyond families with young children, with outbreaks reported on college campuses and communities across the country.
    • “At least 12 people have tested positive for measles at Ave Maria University in Florida, near Naples, since January 29, according to local officials. Three people were taken to the hospital.
    • “A student at the University of Wisconsin-Madison also tested positive after traveling overseas.
    • “Earlier this year, Clemson University in South Carolina confirmed a measles case linked to someone with ties to the school.
    • “It takes only 3 cases of measles for health officials to declare an outbreak.
    • “So far in 2026, at least 17 states have reported infections, according to the US Centers for Disease Control and Prevention (CDC).”
  • CNN tells us,
    • “We often discuss depression and dementia separately, although scientists have long observed a connection between the two: People with depression appear to have a higher likelihood of developing dementia later in life.
    • “A new study published in The Lancet Psychiatry adds an important twistin untangling that relationship and looks beyond depression as a single diagnosis. By focusing on specific symptoms, the research raises a more precise and potentially more useful question: Could certain symptoms in midlife signal greater vulnerability to dementia decades later? And if so, what should people and clinicians do with that information now?”
    • The CNN reporter interviews CNN wellness expert Dr. Leana Wen about the study.
  • Medscape informs us,
    • “As GLP-1s continue to surge in demand, older patients in your practice may inquire about these medications for their weight-loss efforts. Although they are known to improve conditions such as high cholesterol and obesity and help with the management of type 2 diabetes, certain precautions should be considered for patients older than 65 years.
    • “Older adults often do their own research on wellness trends. If they ask about GLP-1 medications, knowing clinical and science-based facts can keep them informed and safe. Some experts say these medications and this patient population should be carefully considered.
    • “[In the article,] Yuval Pinto, MD, DABOM, assistant professor of medicine and part of the Healthful Eating, Activity & Weight Program at Johns Hopkins School of Medicine in Baltimore, laid out some of the risks.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Two years ago, a GLP-1 prescription could cost an uninsured patient more than $1,000 a month. Today, Novo Nordisk’s NOVO.B Wegovy pill starts at just $149 through cash-pay programs. 
    • “In the world of Big Pharma, this is unheard of. 
    • “Typically, drug prices climb or plateau until generics arrive years later. That trend should be even stickier in a duopoly. Yet the obesity market has turned traditional pharma economics upside down. As Leerink analyst David Risinger notes, there isn’t a comparable precedent for this level of price erosion in the industry’s history.” * * *
    • The question both companies [Novo and Lilly] are now racing to answer is just how elastic consumer demand is in the obesity market. Lower prices are clearly unlocking growth in demand, especially in the cash-pay market. As Novo Nordisk Chief Financial Officer Karsten Munk Knudsen argued in an interview this week, this isn’t a price war, so much as a search for the price points that open the floodgates of access.
  • The New York Times lets us know “How to Tell if You Will Save Money Using TrumpRx.”
    • “People may be able to pay less for prescriptions with their insurance rather than via the new government website. The Trump drugstore is meant to help people buy medications using their own money.”
  • Beckers Payer Issues notes,
    • “Elevance Health bid on 11 national accounts in competing Blue Cross Blue Shield markets last year and won nine of them, the company said on its 2025 earnings call with investors, offering the first look at how a landmark antitrust settlement is reshaping competition within the Blues ecosystem.
    • “This is the first year that we’ve had the opportunity for employers in competing geographies against us who could actually quote with our organization if they wanted,” Morgan Kendrick, Elevance’s president of commercial and specialty health benefits, said Jan. 28.
    • “The provision, known as the “second blue bid,” stems from a $2.67 billion settlement that resolved allegations dating back to 2012 that BCBS companies conspired to divide up markets and avoid competing with one another, thereby driving up costs for consumers. Among other changes, the settlement struck down a rule that required large employers to work with the BCBS insurer covering the geography where the employer is headquartered.
    • “Now, for certain large national accounts, employers can solicit bids from any BCBS plan in the country, not just the one licensed in their service area. Elevance’s 9-for-11 record is the first concrete data point on how the settlement is reshaping competition among Blues plans, but industry observers say the effects could stretch beyond one selling season.
    • “Ari Gottlieb, a consultant to insurers and owner of A2 Strategy, told Becker’s the provision will primarily benefit BCBS plans with the existing scale and technology to compete nationally.”

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, Generative AI, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Mehmet Oz arrived on Capitol Hill last week to pitch Republicans on an idea to codify into law President Trump’s drug-pricing model, which ties U.S. pharmaceutical costs to lower prices typically paid abroad.
    • “Oz, the Centers for Medicare and Medicaid Services administrator, could sense the skepticism from GOP senators—members of the Finance Committee—as they raised concerns about industry backlash and a potential chilling effect on innovation.
    • “You read the room,” Oz said in an interview. “When’s the right time to tell them they need to do something different?”
    • “The move marked the opening effort of the administration’s push to advance the president’s planahead of the midterm elections, as healthcare costs have become a top voter concern. While Trump has proposed sending money directly to Americans through Health Savings Accounts to ease those costs, that discussion was absent from Oz’s talks with Republicans, he said.
    • “That’s not the most important issue for us,” said Oz, the former television host and celebrity surgeon widely known as Dr. Oz. He emphasized making sure that pricing deals reached under Trump with more than a dozen pharmaceutical companies endure beyond his time in office.”
  • and
    • “The White House on Thursday launched its drug-pricing website, dubbed TrumpRx, the culmination of efforts by the administration to bring down pharmaceutical costs for some consumers.
    • “When it launched, it had roughly 40 drugs available, including obesity treatments Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound and infertility treatments such as Gonal-F from EMD Serono. The prices for the drugs on TrumpRx were generally much lower than their sticker price, with President Trump touting some discounts of hundreds of dollars a month. The website, TrumpRx.gov, allows customers to search for specific medicines and purchase them through a manufacturer’s direct-to-consumer site, or in some cases gives users coupons that they can present at certain pharmacies.” * * *
    • “The website likely won’t have a substantial impact on the amount most Americans pay for their prescriptions, as most of Americans are insured—either through private or government plans—and are likely to get a better deal on the drugs via their coverage. The roughly 27 million Americans who are uninsured are those most likely to benefit from the direct-to-consumer offerings.” 
  • Here is a link to the White House’s fact sheet on TrumpRx.
  • Govexec tells us,
    • “The U.S. Postal Service on Thursday reported that it experienced a net loss of nearly $1.3 billion in the first quarter of fiscal 2026, as there continues to be a lack of consensus among postal leaders, stakeholders and lawmakers about how to fix the agency’s longstanding financial challenges. 
    • “Officials attributed the loss to a $634 million increase to workers’ compensation, among other spending hikes, paired with a $264 million reduction in operating revenue. In comparison, USPS saw a net income of $144 million during the first quarter of fiscal 2025. 
    • “USPS, however, experienced a net loss of $9 billion in fiscal 2025, and officials have projected that the postal agency will continue to operate in the red for fiscal 2026. 
    • “At a USPS Board of Governors meeting on Thursday, Postmaster General David Steiner and the board reiterated their argument that legislative and administrative reforms, such as raising the postal agency’s $15 billion statutory debt limit, are necessary to reverse these losses.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With online health and wellness company Hims & Hers opening a new front in the GLP-1 compounding showdown Thursday, the United States’ top drug regulator has taken notice.
    • “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products,” FDA commissioner Marty Makary, M.D., said in a Feb. 5 post on X. “The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
    • “Makary’s comments mark a clear and sharp rebuttal to Hims’ announcement earlier in the day that it had launched a compounded version of Novo Nordisk’s new Wegovy (semaglutide) pill for obesity, which starts at just $49 per month.”
  • and
    • “The FDA removed a prior “limitations of use” restriction it had placed on Gilead Sciences’ CAR-T Yescarta, allowing it to be used in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).
    • “Yescarta is approved for R/R large B-cell lymphoma, but previously wasn’t permitted to treat those with the rare, fast-growing PCNSL subtype. Prognoses related to this disease, which originates in the brain, spinal cord, eye, or cerebrospinal fluid, are typically poor, with a five-year survival rate of about 30%. The cancer type has no standard-of-care treatment options and an estimated 1,500 cases are diagnosed annually in the U.S.
    • “Dana-Farber Cancer Institute ran a phase 1 study to evaluate the safety of Yescarta in patients with PCNSL, as those with the disease had previously been excluded from the clinical trials supporting Yescarta’s initial approval, global head of development at Gilead’s Kite unit, Gallia Levy, M.D., Ph.D. explained in a company release.” 
  • MedTech Dive relates,
    • “Johnson & Johnson is recalling certain Cerepak detachable coil systems due to a higher-than-expected failure to detach rate that has been associated with four serious injuries and one death. The events were reported as of Oct. 14.
    • “The failure to detach could result in hemorrhagic and ischemic stroke, procedural delays or the need for additional surgical intervention, according to the Food and Drug Administration, which posted the recall on Thursday.
    • “J&J issued a letter to customers on Oct. 2 recommending they remove certain Cerepak products from where they are used or sold.”
  • Cardiovascular Business tells us,
    • “Zydus Pharmaceuticals, a New Jersey-based distributor of generic drugs, has recalled nearly 23,000 bottles of its icosapent ethyl capsules due to leakage issues that may have weakened their effectiveness. The prescription-strength capsules were manufactured by Softgel Healthcare in India and are sold in the United States as a more affordable option to name-brand treatment options.
    • “Icosapent ethyl is primarily used to help treat patients with high triglyceride levels in their blood. Taken together with a statin, it can also help significantly reduce the risk of heart attack, stroke or other cardiac complications in certain patient populations.
    • “Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients,” according to the Food and Drug Administration (FDA).”

From the judicial front,

  • Fierce Healthcare reports,
    • “The Department of Health and Human Services has officially backed down on its halted 340B Rebate Model Pilot Program, telling the courts this week that it plans to pull relevant notices and application approvals.
    • “Lawyers for the government and plaintiffs who sued to block the program—several hospitals and hospital groups including American Hospital Association (AHA)—filed Thursday afternoon in the U.S. District Court for the District of Maine a joint motion for vacatur and remand. 
    • “The filing acknowledged the preliminary injunction plaintiffs had secured and the government’s failed bid to have the the temporary pause overturned by the appellate court. Both reflected judges’ belief that the hospitals were likely to succeed on the merits of their claims based on at least two administrative issues—”a failure to provide a reasonable explanation or address significant reliance interests and a failure to consider relevant costs.” 
    • “As such, HHS does not believe providing more administrative documents to the court would change any decisions, according to the joint motion.”
  • The Wall Street Journal relates,
    • “Luigi Mangione will face murder and weapons charges in a Manhattan court in June for the killing of UnitedHealthcare CEO Brian Thompson, three months before jury selection in his federal trial for crimes related to the same killing.
    • “New York state court Judge Gregory Carro set a June 8 trial date during a snap hearing Friday, prompting an outburst from Mangione, who claimed he was being denied double-jeopardy protections.” * * *
    • “The Manhattan district attorney’s office argued the state case should go first because the killing occurred in Manhattan and local prosecutors—working with many NYPD detectives—led the investigation that resulted in Mangione’s arrest.
    • “The State has an overriding interest in trying this defendant for the cold-blooded execution of Brian Thompson on December 4, 2024. It resulted in the tragic death of a guest to our city on our streets,” Assistant District Attorney Joel Seidemann said in a letter to the judge.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally with most areas of the country reporting stable or decreasing trends. Emergency department visits are stable and highest among children 5-17 years. Hospitalizations trends continue to decrease overall and are highest among those 65 years and older. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old. RSV hospitalizations are highest among infants less than 1 year old.
    • “COVID-19
      • COVID-19 activity is elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally with most areas of the country reporting stable or decreasing trends; however, activity continues to increase in the Pacific Northwest.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • The University of Minnesota CIDRAP adds,
    • “The effectiveness of this season’s flu vaccine in Canada is 40% against medically attended infection with influenza A(H3N2) viruses, 37% against newly emerged and predominant subclade K of the H3N2 strain, and 31% against the H1N1 influenza A strain, an interim analysis estimates.
    • “Researchers from the Canadian Sentinel Practitioner Surveillance Network (SPSN) conducted the test-negative study, which evaluated samples from patients aged one year or older who had acute respiratory illness. Community-based sentinel health care providers in Alberta, British Columbia, Ontario, and Quebec collected the specimens from October 26, 2025, to January 10, 2026, and the findings were published yesterday in Eurosurveillance.”
  • The AP reports,
    • “During the early years of the COVID-19 pandemic, experts worried that disruptions to cancer diagnosis and treatment would cost lives. A new study suggests they were right.
    • “The federally funded study published Thursday by the medical journal JAMA Oncology is being called the first to assess the effects of pandemic-related disruptions on the short-term survival of cancer patients.
    • “Researchers found that people diagnosed with cancer in 2020 and 2021 had worse short-term survival than those diagnosed between 2015 and 2019. That was true across a range of cancers, and whether they were diagnosed at a late or early stage.
    • “Of course, COVID-19 itself was especially dangerous to patients already weakened by cancer, but the researchers worked to filter out deaths mainly attributed to the coronavirus, so they could see if other factors played a role.”
  • Healio informs us,
    • “As the number of home hazards increased, so did the effect of visual function on the odds of falling.
    • “Home safety evaluations and environmental adaptations could be helpful for adults with low vision.”
  • and
    • “Use of SGLT2 inhibitors was associated with lower 5-year risk for chronic kidney disease and AKI compared with GLP-1 receptor agonists for adults with type 2 diabetes, according to data published in JAMA Internal Medicine.”
  • Radiology Business lets us know;
    • “New research suggests that photon-counting computed tomography scans outshine conventional contrasted chest CT for follow-up imaging of lung cancer. 
    • “Patients who have been diagnosed with the disease require routine imaging to monitor treatment effectiveness and ensure their cancer has not progressed or recurred. This is typically done via standard contrast-enhanced CT scans. Though effective, the standard of care comes with caveats, including increased exposure to both radiation and contrast media. What’s more, image quality can vary based on patient size, which can negatively affect lesion detection and characterization. 
    • “Experts believe that emerging photon-counting technology can help address these shortcomings. Published in RSNA’s flagship journal, Radiology, a new paper details numerous benefits photon-counting CT scans have over conventional CTs, including reduced radiation exposure and enhanced lesion visualization. Experts involved in the study went as far as to suggest that the advanced technology could replace conventional CTs in certain settings soon.”
  • Genetic Engineering and Biotechnology News observes,
    • “If you zoomed in far enough on a new experimental HIV vaccine, you wouldn’t see the usual protein shell that most vaccines rely on. Instead, you’d find tiny geometric structures folded from strands of DNA—molecular origami designed not to be noticed at all. This “invisible” scaffold may be the key to awakening some of the rarest and most sought‑after cells in immunology: the B cells capable of maturing into broadly neutralizing antibody producers.
    • “Many next‑generation vaccines use virus‑like particles (VLPs)—nanostructures that mimic the outer shape of a virus but contain no genetic material. By displaying many copies of a viral antigen on their surface, VLPs can activate B cells far more effectively than free‑floating proteins. The paper is titled “DNA origami vaccines program antigen-focused germinal centers,” and was published recently in Science. 

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

  • Fierce Healthcare reports,
    • “Centene is “laser-focused” on improving the performance of its Medicaid business following a difficult 2025.
    • “CEO Sarah London told investors Friday morning on the company’s earnings call that the team made headway in this effort in later part of 2025, with it’s Q4 medical loss ratio of 93% on par with expectations set for analysts in October and showing notable improvement from the second quarter of 2025.
    • “She said that utilization trend patterns seen in the third quarter largely carried into Q4, with behavioral health as the largest driver. Home health services and high-cost pharmaceuticals were also key factors in cost and utilization trends seen in the back half of the year, she said.
    • “And while a spike in flu and other respiratory illnesses generated headlines late in the year, London said that utilization patterns in its Medicaid population were on par with expectations.
    • “As an organization, we have been laser-focused on restoring our Medicaid business to sustainable profitability while maintaining our focus on quality outcomes for our members and the communities we serve,” London said.”
  • and
    • “Molina Healthcare’s share price plunged on Friday as it posted a $160 million loss in the fourth quarter as well as guidance for 2026 that fell short of analysts’ expectations.
    • “Shares in the company were down by about 28% at 11:30 a.m. ET, with its stock tumbling out of the gate at market open on Friday. By comparison, Molina earned $251 million in profit for the fourth quarter of 2024.
    • “For the full year, Molina has posted $472 million in profit, down from $1.2 billion in 2024.
    • “In the earnings report, Molina revealed that it will exit the Part D space in the 2027 plan year due to financial pressure, including Medicare Advantage prescription drug (MAPD) plans. The company will focus on its existing dual-eligible business in Medicare, according to the announcement.”
  • Healthcare Dive relates
    • “Primary care physicians spend a significant amount of time on work in their electronic health records, even when they decrease the number of appointments they schedule with patients, according to new research published in Health Affairs.
    • “Physicians who cut back appointments saw their visit volume decline by 32.6% compared with other doctors. But their EHR time fell by just 21.2% — meaning the number of minutes spent in their records systems actually increased per visit by more than 20%, according to the study. 
    • ‘Primary care physicians need to handle a lot of tasks outside appointments, like responding to patient messages, researchers wrote. So reducing visits doesn’t necessarily eliminate a host of EHR tasks — though it does have repercussions for physicians’ pay and patients’ access to care, they noted.” 
  • and
    • “Epic rolled out an artificial intelligence tool this week that drafts clinical notes, setting up the nation’s largest electronic health record vendor as a major competitor in the ambient scribe market. 
    • “AI Charting, part of Epic’s AI tool called Art geared toward clinicians, listens during patients’ appointments with providers and can suggest orders based on the conversation. The product also allows clinicians to personalize the note’s structure using voice commands, like asking the tool to format current conditions as a bulleted list, according to a press release. 
    • “Epic plans to expand beyond documentation to make the tool “an active assistant in the room,” Corey Miller, Epic’s vice president of research and development, said via email. “This is really just the start for Art,” he said.”
  • Fierce Healthcare adds,
    • “Infinitus has launched a new suite of agentic artificial intelligence tools for healthcare payers that aim to improve member engagement through personalized communications.
    • “Infinitus is an AI company that helps call centers better handle inbound call volumes. For payer organizations, pressured to control costs as call volumes rise and ratings of members demand a modern consumer experience, AI is positioned to solve both issues. 
    • “With the Agentic AI Member Services Suite, health plan members have 24/7 access to an AI agent that can answer simple administrative questions, onboard members, triage questions and navigate care. Through messaging and calling capabilities, Inifinitus’ AI agents can proactively reach out to patients and scale member services without adding team members.”
  • and
    • “Aetna is continuing to build out its digital member experience with the launch of a new onboarding program designed to ease the process.
    • “The insurer said Thursday that the platform will be available to 4 million new members during the welcome period for their enrollment. The program leads on Rich Communication Services, or RCS, to support navigation and connect members with key information and resources they may need after enrolling in a new plan through text messaging.
    • “Nathan Frank, senior vice president and chief digital and technology officer for Aetna, told Fierce Healthcare that building trust with the member requires an end-to-end experience, and tech like the new onboarding program can play a key role in that effort.
    • “Onboarding isn’t just about administration and signing people up and making sure that you have the right information,” he said. “It’s the moment when members decide whether their health plan feels simple, or is it overwhelming?”