Thursday report

Medicare

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

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.”

Midweek report

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The New York Times reports,
    • “The director of the National Institutes of Health, Dr. Jay Bhattacharya, will take on the additional role of acting director of the Centers for Disease Control and Prevention, two administration officials said on Wednesday.
    • “Dr. Bhattacharya will continue to run the N.I.H., according to the officials, who insisted on anonymity to speak about personnel decisions before President Trump announces them. He will serve until Mr. Trump appoints a permanent director — a position that now requires confirmation by the Senate.
    • “The C.D.C. has run through a series of leaders since Mr. Trump returned to the White House last year.
    • “A physician and medical economist who left Stanford University to join the Trump administration, Dr. Bhattacharya has no formal training in public health. But his research has focused on the well-being of populations, which is the core mission of public health, and thus the C.D.C.”
  • Bloomberg Law relates,
    • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz said Tuesday that potential legislation to codify the Trump administration’s plan to link US drug prices to lower prices in other countries would need to take into account the needs of the pharmaceutical industry. 
    • “I think we’ve established a deep passion to preserve innovation,” Oz said at an annual forum hosted by the Pharmaceutical Research and Manufacturers of America, as he discussed the Trump administration’s most-favored-nation proposal. “If it’s not done right, a future administration will take more drastic, draconian steps in ways that would hurt this industry.”
    • “Oz also said during his fireside chat at the PhRMA forum with Pfizer Inc. CEO Albert Bourla that he wanted to “codify MFN in a way that industry finds is reflective of what was signed in the contracts.”
  • The American Hospital Association tells us,
    • “The Department of Health and Human Services Office for Civil Rights Feb. 13 announced the launch of a program to implement and enforce statutory and regulatory requirements under 42 CFR Part 2, which protect the confidentiality of substance use disorder patient records. As of Feb. 16, the program uses a range of civil enforcement mechanisms, including civil money penalties, to ensure compliance with new provisions from section 3221 of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act. This section aligns federal privacy standards for SUD records more closely with those under HIPAA and strengthens confidentiality protections. In compliance with the provisions, HHS OCR has begun accepting complaints of alleged confidentiality violations and SUD record breach notifications.”
  • Adam Fein, writing in his Drug Channels blog, let us know,
    • “The Centers for Medicare & Medicaid Services (CMS) has just released its initial 2026 data on enrollment in Medicare Part D prescription drug plans (PDPs).
    • “DCI’s exclusive analysis shows that 83% of seniors remain enrolled in PDPs with preferred pharmacy networks—essentially unchanged from 82% in 2025, but sharply lower than the 99% peak in 2023. Meanwhile, the number of major Part D plans offering preferred networks has fallen to a record-low eight.
    • “The new enrollment data reveal a clear shift in competitive positioning: Albertsons and Publix are now preferred in every major plan. Walgreens is holding strong. Walmart—the company that invented the Part D preferred network model—has slipped to the middle of the preferred pack.
    • “Meanwhile, smaller pharmacies have fully abandoned PDPs’ preferred networks in 2026. 
    • “At the same time, the IRA’s expansion of the Low-Income Subsidy (LIS) means a growing share of beneficiaries have little financial incentive to use a preferred pharmacy at all. Add in the PBM reforms in the Consolidated Appropriations Act of 2026, and the preferred network model will gradually lose relevance.” 

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration reversed course and agreed to begin a review of Moderna’s MRNA 6.08%increase; green up pointing triangle application to sell a new seasonal flu shot after the vaccine maker agreed to conduct additional testing in the elderly.
    • “The move means that Moderna’s experimental flu shot is largely back on track after the FDA’s surprise decision earlier this month to refuse to start a review of its application. The decision came after discussions with White House and health department officials, people familiar with the matter said. Moderna said it also met with the FDA and proposed a revised approach. 
    • “Now, the FDA will review the application and is expected to make a decision by August, though approval isn’t guaranteed. If approved, Moderna’s flu shot, mRNA-1010, could become available for the 2026-27 flu season.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration has accepted Bristol Myers Squibb’s approval application for its experimental multiple myeloma drug iberdomide, setting a decision deadline of Aug. 17, the company said Tuesday. The drug, from a new class of protein-degrading treatments, is intended for use in combination with Johnson & Johnson’s Darzalex and the steroid dexamethasone in people whose disease has advanced or become resistant to early lines of treatment.” 
  • MedTech Dive informs us,
    • “Medtronic has received Food and Drug Administration clearance for a next-generation spine surgery system that combines artificial intelligence-based planning, real-time navigation and robotic assistance.
    • “The Stealth AXiS system has a modular design that can be used in both hospital settings and ambulatory surgery centers and can accommodate a range of surgeon preferences, Medtronic said Friday.
    • “The underlying architecture can also support cranial applications and ear, nose and throat surgeries, pending 510(k) clearance, according to the device maker.”
  • and
    • “Medtronic said Tuesday that a surgeon completed the first U.S. procedure for its Hugo robotic surgery system, shortly after the company received Food and Drug Administration clearance for the platform.
    • “The first surgery was a prostatectomy procedure performed at the Cleveland Clinic. Along with the Cleveland Clinic, Duke University Hospital and Atrium Health Wake Forest Baptist High Point Medical Center are among the first hospitals in the U.S. to install Hugo, with Atrium Health being the first hospital in the U.S. to do so that was not part of the investigational device exemption clinical study.”
  • Beckers Hospital Review notes,
    • “The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), for use in cancer patients at risk of infection due to chemotherapy.
    • “Filkri is indicated for patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia undergoing induction or consolidation therapy, bone marrow transplant recipients, individuals with severe chronic neutropenia and patients exposed to myelosuppressive radiation.
    • “The biosimilar marks the sixth FDA-approved product in Accord BioPharma’s biosimilar portfolio and the seventh overall, according to a Feb. 17 news release.”

From the judicial front,

  • Bloomberg Law reports,
    • “A prominent US physicians group is suing the Trump administration, alleging it violated its free-speech rights over its public support of gender-affirming care for minors.
    • “The American Academy of Pediatrics said it was hit in January with a Federal Trade Commission civil investigative demand for a “sweeping array of information” that includes comments the group has made about gender dysphoria treatment and communications with other groups regarding the development of clinical guidance on gender-affirming care.
    • “Filed Tuesday in the US District Court for the District of Columbia, the complaint is the latest turn in an ongoing battle between the AAP and the Trump administration.
    • “The parties are fighting in another federal court over Trump administration vaccine policy under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr.”

From the public health and medical / Rx research front,

  • Progeny Health released its “2026 Progeny Health Trends Report — your essential guide to the evolving landscape of maternal and infant health in America.” Check it out.
  • Cardiovascular Business reports,
    • “Reducing the activity of a specific protein, RBM20, may provide significant relief for certain patients with heart failure, particularly those with preserved ejection fraction (HFpEF), according to a new analysis published in Cardiovascular Research.[1] 
    • “HFpEF is associated with stiff, rigid cardiac muscles. A team of researchers out of the University of Missouri School of Medicine believe they may be able to improve HFpEF symptoms by limiting RBM20’s influence in the heart and encouraging another protein, titin, to thrive. 
    • “Titin is a protein found in cardiac muscle cells and acts as a ‘spring,’ enabling the heart chamber to recoil and stretch sufficiently,” lead author Mei Methawasin, MD, PhD, said in a statement. “In HFpEF, it’s common for the titin to stiffen and no longer be as flexible. We learned that if we reduced the activity of a different protein, RBM20, it caused longer and more flexible filaments of titin and significantly improved heart filling in mice.”
    • “There are certain risks associated with too much RBM20 inhibition. Methawasin emphasized that it would be critical to find the “right balance” and not taking things too far.” 
  • Per a National Institutes of Health news release,
    • “A study in mice found that after a bone fracture, the nerves that sense pain also promote healing by signaling for bone repair and wound healing.
    • “The findings could lead to new treatments that stimulate bone repair and might be used to drive bone formation in bone disorders such as osteoporosis.”  
  • Per Healio,
    • “Less than 2 extra hours of walking per week could help mitigate the increased mortality risk among women with breast cancer who also have a higher genetic predisposition to obesity.
    • “An analysis of more than 4,000 women with breast cancer found those who have the highest value of genetic score genes linked to obesity had a 15% greater risk for death than those with the lowest value.
    • “However, if women in that highest tertile of the genetic score walked approximately 15 additional minutes per day, their mortality risk would be similar to those with lower scores.”
  • Per Health Day,
    • “A new advance might help doctors improve movement in people with Parkinson’s disease by tracking their gait-related brain waves in real time.
    • “An experimental brain implant can capture the signals of movement-related brain regions while Parkinson’s patients perform daily activities like walking to the kitchen or strolling through a park, researchers reported Feb. 13 in the journal Science Advances.
    • “What’s more, researchers have figured out how to read those brain recordings, allowing a deeper understanding of the gait problems associated with Parkinson’s, researchers said.”
  • Per Fierce Pharma,
    • “With their blockbuster obesity drugs, Eli Lilly and Novo Nordisk have uncovered a variety of ailments the incretin treatments can combat.
    • “Chalk up another new potential expansion for Lilly as it has found in a phase 3b trial that combining Zepbound and its autoimmune treatment Taltz can provide added benefits for psoriasis patients who are obese or overweight.” 
  • and
    • “Less than half a year after winning an inaugural green light in chronic hives, Novartis’ oral BTK inhibitor Rhapsido is jockeying to expand its urticaria reach into a new indication where it has the potential to become the first targeted therapy. 
    • “In top-line results issued Wednesday, Novartis revealed that a phase 3 trial of Rhapsido (oral remibrutinib) met its primary endpoint in patients with the three most prevalent types of chronic inducible urticaria (CIndU): symptomatic dermographism, cold urticaria and cholinergic urticaria. 
    • “Specifically, the company’s BTK inhibitor helped patients achieve “significantly higher complete response rates” compared with placebo after 12 weeks of treatment, Novartis said in a Feb. 18 press release.” 

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

  • Beckers Payer Issues points out
    • “Paul Markovich, president and CEO of Ascendiun, the parent company of Blue Shield of California, is not one to sugarcoat the state of the healthcare system.
    • “I don’t see how you can look at it and say there isn’t a fundamental problem. It’s systemic in nature,” Mr. Markovich said on the Becker’s Healthcare podcast.
    • “Mr. Markovich was one of five health insurance CEOs who testified before House lawmakers in January over the broad topic of rising healthcare costs. The hearings lasted more than nine hours and covered industry consolidation, prior authorization and executive compensation. Most people would be nervous to be summoned before Congress in general, much less to speak to lawmakers about controversial topics — but not Mr. Markovich.” * * *
    • “His message to the industry is blunt: Stop asking for more money.
    • “This is our new normal. We have to, as many other industries have, figure out how to make an impact and do better with fewer resources and be more productive. That has not been the mindset of the industry for most of my career,” he said.
    • “We have to get into a different mindset: How do we make healthcare affordable? We all have to be financially viable, but how do we make healthcare affordable and worthy of our family and friends? That means we have a cost problem that we need to address,” he added. “I’m hopeful that creating that kind of budgetary, top-down pressure helps create that mindset and gets us into a much more innovative phase in healthcare, one where we really are focused on how to make things better for the patient and more efficiently.”
    • “To listen to the full conversation with Mr. Markovich about PBM reform, the company’s efforts to unbundle pharmacy benefits and keep Blue Cross Blue Shield plans competitive, plus his scathing rebuke of fax machines, you can tune in here.“
  • Modern Healthcare reports,
    • “More than 20 health systems have teamed up in a bid to use technology to improve access to care in rural and underserved areas. 
    • “The National Specialty Care Access Coalition, which launched Wednesday, will prioritize standardizing care models, reforming policy and deploying pilots to speed innovation, a news release said.
    • The model enables shared learning and a unified perspective, among other advantages, according to its website.
  • MedCity News tells us,
    • “Daffodil Health, an AI platform for health plan administration and claims processing, has raised $16.3 million in Series A funding to help scale the company, it announced on Tuesday.
    • “The San Francisco-based startup provides AI-based software for U.S. health plans and third-party administrators to manage claims pricing and payment integrity. Its platform allows payers to handle out-of-network repricing in-house, using transparent benchmarks and real-time reporting. This work has historically been outsourced to vendors that have built “multi-billion dollar businesses sitting between providers and payers,” according to Navin Nagiah, CEO and co-founder of Daffodil Health. It offers a SaaS pricing model, versus a percentage-of-savings pricing model that companies like MultiPlan and Zelis use.
    • “We have automated that entire workflow end-to-end,” he said. “When a claim comes in, we benchmark it against market data, Medicare rates, historical allowed amounts by MSA, percentile distributions, and even provider-specific acceptance history. It takes minutes to configure, and then the system runs automatically claim by claim. Our goal is to give plans control, automation, and transparency at a fraction of the historical cost.”
  • Fierce Healthcare adds,
    • “Optum is rolling out a new AI tool that aims to address some of the key barriers to value-based care, from data fragmentation to administrative burden.
    • “The company said in an announcement on Wednesday that the Value Connect platform supports both payers and providers in value-based care work, leaning on artificial intelligence to surface ways to improve and identify areas where programs are underperforming. The tool can also identify and quickly facilitate interventions that improve outcomes, either directly or embedded within other platforms, Optum said. 
    • “The goal of Value Connect, per the company, is to make it easier for payers and providers to collaborate as well as improve the performance of value-based care programs.
    • “We’re accelerating the shift to value-based care by meeting payers and providers where they are in their journey,” said Beth Merle, senior vice president of provider enablement at Optum Insight, in the announcement. “The solution empowers organizations to proactively manage risk and costs while improving outcomes for the people they serve.”
  • Health Data Management informs us,
    • “Clinician turnover and burnout have been two of the core issues threatening healthcare, with staffing trends already having been exacerbated by the COVID-19 pandemic. 
    • “However, there are growing indications that some of the churn caused by revolving-door policies to staffing are abating. But a recent report suggests that some of the negative effects of staffing upheaval remain, including restrictions on access, rising cost pressures and inconsistent outcomes. 
    • “Still, the suggestion that staff churn is abating suggests that healthcare organizations are improving efforts to find appropriate clinicians and staff, and then keeping them happier and willing to stay where they are.” 
  • Per MedCity News,
    • “Eli Lilly has been scouting for drugs to follow the trail blazed by its blockbuster cardiometabolic medicines. Its latest pipeline-building deal has the pharmaceutical company paying $100 million for rights to a clinical-stage CSL Limited drug addressing an increasingly competitive target associated with chronic inflammation.
    • “Under deal terms announced late Tuesday, CSL retains rights to the drug, clazakizumab, for prevention of cardiovascular events in patients with end-stage kidney disease while Lilly gains rights in other indications. Lilly has not disclosed its plans for the antibody but cardiovascular disease has become a particular area of interest for the company and it’s also the focus of clinical-stage programs in clazakizumab’s drug class.
    • “Clazakizumab is a monoclonal antibody designed to bind to and block IL-6, a signaling protein that in excessive amounts plays a role in inflammation. While FDA-approved antibody drugs that block this target have already reached the market in certain inflammatory disorders, there’s renewed industry interest in expanding this approach to more diseases, particularly the inflammation that drives cardiovascular conditions.”
  • Per Fierce Pharma,
    • “With $55 billion earmarked to bolster its U.S. operations, Johnson & Johnson is the latest drugmaker to zero in on expansion plans that are aimed, at least in part, at abating the Trump administration’s pharmaceutical tariff threats. 
    • “J&J will spend more than $1 billion to build out a next-generation cell therapy production plant in Montgomery County, Pennsylvania, the company said in a Feb. 18 release. Once up and running, the facility will create some 500 new permanent biomanufacturing positions, not to mention more than 4,000 construction jobs while the plant is being developed, J&J said. 
    • “J&J did not lay out a timeline for the plant’s expected completion, nor did the company specify the types of “cutting-edge cell therapy technologies” it plans to employ at the new site. 
    • “Still, Wednesday’s announcement adds more color to J&J’s overall $55 billion U.S. investment plan, unveiled last March, which came with a pledge to construct three new domestic manufacturing sites and expand others in the company’s existing drug and medtech network.” 

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.”

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.”

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.”

Midweek report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend update

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

From Washington, DC,

  • The Wall Street Journal reports.
    • “Speaker Mike Johnson (R., La.) faces a tougher-than-expected vote to end a partial government shutdown this week, after House Democrats pushing for sweeping changes to immigration enforcement signaled they wouldn’t help Republicans pass any funding measures through the narrowly divided chamber.
    • “Johnson, with a 218-213 majority, will need to keep almost all Republicans on board or risk the shutdown that started Saturday stretching deep into the week. The measure, endorsed by President Trump, funds swaths of the government for the rest of the fiscal year, while providing a two-week extension for the Department of Homeland Security—which contains immigration-enforcement agencies. The extension is intended to jump-start talks on reining in enforcement officials’ practices.
    • “I’m very optimistic that we will get everyone back in town,” Johnson said Sunday in an interview, referring to GOP lawmakers. “We will convince them that we need to implement the president’s play call,” giving the White House time to discuss changes to DHS with Democrats.” * * *
    • “Johnson’s tiny vote margin gives any one or two GOP members powerful leverage if they want changes or concessions. Johnson as soon as Monday is expected to swear in Christian Menefee, a Democrat who just won a Texas special election to represent Texas’ 18th Congressional District after former Rep. Sylvester Turner’s death last year. That will bring the majority to 218-214.”
  • Here’s a link to Roll Call’s take on what to expect to occur on Capitol Hill this week.
  • The American Medical Association tells us,
    • “The influential Medicare Payment Advisory Commission (MedPAC) voted in January to address inadequate payment for Medicare physician services under current law, once again underscoring a longstanding policy failure that is widely recognized but remains unresolved.
    • “MedPAC voted to recommend an additional 0.5% update on top of the updates specified in current law—0.25% and 0.75%—and will forward that recommendation to Congress. 
    • “The AMA appreciates that last year’s reconciliation bill provided a temporary 2.5% update for 2026; however, that increase expires in 2027. Absent meaningful reform, physicians again will face payment cuts, and Congress will once more be forced into last-minute efforts to avert further disruption,” AMA Board Chair David H. Aizuss, MD, said in a statement.
    • “The AMA is leading the charge to reform the Medicare payment system. That includes strongly urging MedPAC to recommend to Congress that they update 2027 physician payment rates so that they keep pace with the Medicare Economic Index (MEI).” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today began accepting requests to participate in the FDA PreCheck pilot program. FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.
    • “After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.”
    • “The agency will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the U.S. market.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “There’s been a small but “alarming” bump in aortic stenosis (AS) deaths among people ages 45 to 74 in recent years, according to nationwide trends.
    • “In this younger group, age-adjusted AS mortality rates had been relatively stable until 2019, when they started climbing from a rate of 3.33 per 100,000 to 3.57 per 100,000 in 2023 — a statistically nonsignificant change that is notable nonetheless, according to Sameer Hirji, MD, MPH, of Brigham and Women’s Hospital in Boston.
    • “In comparison, those ages 75 and older showed a consistent decline in age-adjusted AS mortality rates from 2012 (112.3 per 100,000) to 2023 (104.1 per 100,000) based on the CDC WONDER database, Hirji reported at the Society of Thoracic Surgeons (STS)opens in a new tab or window annual meeting.
    • “This emerging trend — spanning sex, race, and geography — demands urgent evaluation of existing screening practices, timely diagnosis, and equitable access to both transcatheter and surgical therapies,” he concluded.”
  • The Washington Post relates,
    • “For years, scientists have been working to unravel the mystery of patients with failing kidneys dying from heart-related complications.
    • “Researchers now say they’ve uncovered a clue that explains why people with chronic kidney disease have such a high risk of heart failure — and it could have major implications for the diagnosis and treatment of the two common health conditions.
    • “A new study found that diseased kidneys released tiny particles that were toxic to the heart, according to findings published recently in the peer-reviewed journal Circulation.” * * *
    • “That molecular discovery is helping to shed light on one way the kidney and heart are linked — and, in this case, to dangerous effect, said Susmita Sahoo, the study’s senior author and an associate professor of medicine at the Cardiovascular Research Institute at the Icahn School of Medicine at Mount Sinai.
    • “No one has shown this causal relationship before,” Sahoo said.” * * *
    • “Sahoo said her team’s findings could help identify heart disease in kidney patients earlier, before they show symptoms.
    • “By measuring these cardiotoxic microRNAs, you can actually predict or identify or diagnose the patient who are on the way to developing a failing heart,” she said.
    • “The research can also influence treatment recommendations, said Erdbrügger, the study co-author who is also a practicing kidney doctor. For instance, Erdbrügger said if she knew one of her kidney patients had a higher risk of heart disease, she would consider treating more aggressively by increasing drug dosages or using more combinations of medications.”
  • The Wall Street Journal tells us,
    • “Federal regulators issued a safety warning, telling used-car owners in the U.S. to examine their vehicles’ maintenance histories regarding air-bag safety.
    • “NHTSA said nine people have died and two were injured in otherwise-survivable crashes after DTN inflaters ruptured.
    • “NHTSA urged drivers who find that their vehicles experienced an air-bag deployment to have an inspection.” * * *
    • “If a DTN inflater is found, the vehicle should not be driven until you are able to have it replaced with genuine parts,” NHTSA said.
  • NPR Shots informs us,
    • “Building strength and muscle comes with huge payoffs for health and longevity, but most Americans still don’t lift weights or regularly practice any muscle-strengthening activity.
    • “Why? People often blame a lack of time.
    • “Exercise physiologist David Behm says often when he talks to people about resistance training they seem to think they’d need hours in the gym to get results, working through rows of machines targeting each muscle.
    • “They’re like ‘my God, I’m going to be in there for an hour and a half or longer,” says Behm, a professor at Memorial University of Newfoundland in Canada.” * * *
    • “The evidence shows you can make real gains in strength and muscle with as little as one or two quick workouts a week — depending on the approach, you might be able to get away with as little as a half hour in the gym (or even less).
    • “The key is focusing on what are called multi-joint exercises, or compound lifts.”
  • The New York Times points out,
    • “A study published this week in the journal JAMA Pediatrics found that a close, nurturing relationship with parents during middle and high school was associated with a variety of positive social metrics up to two decades later.
    • “Researchers looked at six outcomes, such as having three or more close friends or socializing at least once a week. They found that high social connection in adulthood was more than twice as common among those who had felt the strongest family ties in youth, compared with those who had felt the weakest.
    • “We tend to think of adult loneliness or low social connectedness as byproducts of individual choice or adult social structures,” said Dr. Andrew Garner, a pediatrician and researcher at Case Western Reserve University, who was not involved in the research. This study, on the other hand, “forces us to think developmentally.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “2026 is an “execution year” for Teladoc Health, CEO Chuck Divita told Healthcare Dive.
    • “The telehealth company has spent the past year focusing on a strategy shift, prioritizing international expansion, improving operating efficiency, better leveraging its mental health assets and enhancing its integrated care business.
    • “The goal is to deliver sustainable long-term growth at Teladoc, which has seen its stock price decline significantly from the heights reached during the COVID-19 pandemic. To that end, the virtual care giant completed multiple acquisitions last year, launched new products and began accepting insurance coverage at its direct-to-consumer mental health arm BetterHelp. 
    • “I believe that we have the right strategy, the right priorities, and it’s really about execution now,” said Divita, who took up the role as Teladoc’s chief executive about a year and half ago.”
    • For the full interview, read the article. 
  • McKinsey & Co. discusses the changing contours of health and wellness.
    • “As 2026 takes shape, long-held notions of health and wellness, both in and out of the workplace, are evolving—expanding beyond disease prevention to focus on longevity, performance, and quality of life.
    • “Advances in healthspan science are driving biomedical innovations that contribute to healthy longevity, while the rapidly evolving wellness economy reflects shifting consumer expectations around fitness, nutrition, and healthy aging. McKinsey Health Institute research from Barbara Jeffery, Jacqueline Brassey, Lucy Pérez, and Darshini Mahadevia also shows that workplace health interventions can deliver measurable gains for both individuals and organizations. 
    • “As you navigate your own wellness journey this year, explore these insights on what it means to live a healthier, more fulfilling life.”
  • Per Fierce Healthcare,
    • “Maven Clinic launched a research institute on Thursday to rally further research and collaboration in digital health.
    • “The Clinical Research Institute is based on what Maven claims is the largest public evidence base measuring the impact of virtual care on women’s and family health. Maven has published over 40 peer-reviewed publications. A clinical research team, including Maven’s chief medical officer, is part of the center and driving its research and collaborations with partners.
    • “The goal is to serve as a platform for partnerships across academia and industry while expanding the scope of women’s and family health research. Current and past research partners include Harvard Medical School, Brown University, Posterity and OURA, with additional studies planned.
    • “The Institute also advances research through Maven’s Visiting Scientist program. Visiting Scientists work part-time with Maven for up to one year, contributing to research that informs care delivery and helps translate evidence into practice.”
  • and
    • “Nourish, a virtual nutrition provider, is launching a program that gives patients access to free cardiometabolic lab testing. 
    • “Nourish Labs will integrate blood testing into personalized nutrition care. The free basic panel will include key cardiometabolic markers like cholesterol, A1C and thyroid-stimulating hormone. An enhanced lab panel for insights into heart and hormone health will be available for a small add-on cost. 
    • “The objective measurement will improve treatment plans and strengthen patient engagement, executives say.
    • “We had just really wanted to, for a long time, bring it in-house and to be able to do this ourselves,” Aidan Dewar, co-founder and CEO of Nourish, told Fierce Healthcare in an exclusive advanced interview.”

Midweek report

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Democrats demand an overhaul of immigration enforcement, tying it to passing a $1.3 trillion spending package to avert a government shutdown.
    • “Democrats propose changes including: ending roving patrols, tightening warrant rules and requiring ICE coordination with local law enforcement.
    • “The standoff follows two fatal shootings by federal immigration agents in Minneapolis, with Democrats refusing to fund DHS without revisions.”
  • The Hill adds,
    • “House Republicans are warning the Senate against making any changes to a government funding package that includes funds for the Department of Homeland Security (DHS), saying any reforms sought by Democrats would not clear the House and would lead to a government shutdown at the end of the week.
    • “Conservatives also say they would seek significant concessions from Democrats if they were to split up the six-bill funding package and tinker with the DHS spending bill — threatening to seek avenues to fund the department without needing support from Democrats.
  • The House Budget Committee identified highlights from last week’s hearing on how to reverse the healthcare cost curve. One of the experts that the FEHBlog admires, Avik Roy, observed,
    • “Mr. Avik Roy, Foundation for Research on Equal Opportunity: I’d encourage you to look at the World Index of Health Care Innovation that my organization puts out every year. FREOP, which looks at a lot of these metrics of how we measure the quality of the health care system, what we can learn from other countries, what they can learn from us. On the point about options other than health insurance, first of all, we have to make health insurance more affordable. You can do a lot to have alternatives to health insurance, and I will talk about that, but we, the people, still need affordable options for health insurance. The fact that the Affordable Care Act made health insurance massively more expensive for people who buy it on their own is a huge problem, because the foundation of free market health insurance is you buying that health insurance for yourself, not depending on your employer to buy it for you, not depending on the government to buy it for you. You buy it for yourself, and maybe the government helps you pay for that premium.“
  • FEHBlog note — The FEHB Program would be a good model for choice but for the fact that the U.S. Office of Personnel Management has been benefit mandate crazy in recent years. OPM needs to revoke those mandates.
  • The Wall Street Journal tells us,
    • “The Census Bureau’s first snapshot of population data for 2025 confirms some big trends, like a major shift in immigration as the U.S. cracks down on border crossings and steps up deportations. 
    • “The estimates, which cover the 12-month period ended in mid-2025, also uncovered some surprises regarding the comings and goings between states. Some places in the Midwest, for example, are seeing a net influx of people from within the U.S. for the first time in years.” ***
    • “The U.S. added slightly more babies, but not enough to move the needle significantly on population growth. Births ticked up about 12,200 on the year to 3.6 million. That is better than the decline of 40,700 in the prior year, but it didn’t shift a still-falling birthrate that has become a concern among some Republicans.”
  • The American Hospital Association New informs us,
    • “The Centers for Medicare & Medicaid Services Jan. 28 released a proposed rule that would update conditions for coverage for organ procurement organizations. The proposal would eliminate regulatory requirements that limited the Secretary of Health and Human Services in certifying new OPOs, clarify the OPO designation process, modify the appeals process for OPOs, and update and add certain key definitions, among other changes. CMS also seeks comments on various topics, including a new process to certify OPOs; conflicts of interest in organ and tissue procurement; automated electronic referrals, from donor hospitals to OPOs; and alternative approaches to OPO designation and non-renewal of OPO agreements.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of 21 new members to the Interagency Autism Coordinating Committee (IACC). These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to support breakthrough innovations in autism research, diagnosis, treatment, and prevention by bringing the nation’s understanding of and policies concerning autism into alignment with gold-standard science.”
  • MedCity News points out,
    • “While the 15 medications selected for the latest round of the federal government’s drug price negotiation program will face steep cuts in what Medicare will pay, the financial impact to pharmaceutical companies is expected to be minimal.
    • “Leerink Partners analyst David Risinger said in a Wednesday research note that Gilead Sciences HIV drug Biktarvy is the only one of the selected products with Medicare exposure that is material to its manufacturer’s sales, accounting for about 8% of Gilead’s 2027 estimated global revenue. Rexulti, a drug approved for schizophrenia among other neurological indications, has the second-largest exposure, with revenue from Medicare estimated to be about 3% of Lundbeck’s global sales. But Risinger said this exposure for Lundbeck is overstated because the company shares in commercialization of the drug with partner Otsuka Pharmaceutical.”
  • Avalere Health explains how this week’s “2027 Advance Notice Materially Alters Part D Risk Adjustment.”
  • Tammy Flanagan, writing in Govexec, discusses “how federal employees can protect a spouse in retirement”
    • “To better understand their potential benefits and financial risks in retirement, both spouses should be aware of some benefits planning realities.”

From the Food and Drug Administration,

  • Fierce Pharma reports,
    • “Even as Johnson & Johnson’s oncology superstar Darzalex Faspro racks up megablockbuster sales and reshapes the multiple myeloma treatment paradigm, the drug is still finding ways to consolidate its position. This week, the drug is doing just that with an FDA nod for a more powerful regimen in newly diagnosed patients who are ineligible for autologous stem cell transplant.
    • “The Jan. 27 approval enables Darzalex Faspro’s use within a quadruplet combination that includes Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone (VRd), which is altogether referred to as D-VRd. Before that, the triplet regimen of D-Rd has been allowed to treat first-line, transplant-ineligible patients since 2019. 
    • D-VRd is now the only anti-CD38 antibody-based regimen that can treat newly diagnosed patients regardless of transplant eligibility, J&J said in a Jan. 27 press release.”
  • BioPharma Dive adds,
    • “Regenxbio lost almost a fifth of its value Wednesday after the Food and Drug Administration placed a clinical hold on two of the company’s experimental gene therapies.
    • “Regulators acted after researchers found a case of brain cancer in a 5-year-old child who had received one of the treatments, RGX-111, four years earlier. The agency decided to extend the hold to the second therapy, RGX-121, because of similarities between the two and “shared risk between the clinical studies,” Regenxbio said Wednesday.
    • “The company said there has been no causal link between RGX-111 and the child’s condition and emphasized that RGX-121 is a separate therapy with years of safety data. “We are surprised by FDA’s decision to place our RGX-121 program on hold while the investigation of this single, inconclusive incident in RGX-111 continues,” CEO Curran Simpson said in the statement.”

From the public health and medical / Rx research front,

  • Infectious Disease Advisor reports,
    • “Millions of COVID-19-associated illnesses and outpatient visits as well as thousands of hospitalizations and deaths continued to occur annually in the United States from late 2022 through 2024, despite the formal end of the public health emergency, according to a cross-sectional analysis published in JAMA Internal Medicine.
    • “To provide updated national estimates during a period marked by evolving SARS-CoV-2 variants, changes in testing practices, and increasing population immunity, investigators analyzed data from the COVID-19 Hospitalization Surveillance Network. Using hierarchical Bayesian modeling and probabilistic multiplier methods, the investigators estimated the national burden of symptomatic illnesses, outpatient visits, hospitalizations, and deaths across 2 surveillance periods aligned with influenza seasons: October 2022 to September 2023 and October 2023 to September 2024.”
  • The Wall Street Journal informs us,
    • “A recent email ad from a telehealth company selling weight-loss medications features tennis-superstar Serena Williams.  
    • “If you’re carrying 15-20 extra pounds,” it says, “medications like Wegovy can help jumpstart your progress.”
    • “For obesity doctors and researchers, this kind of messaging is problematic. The blockbuster drugs—known as GLP-1s—are increasingly marketed as lifestyle fixes to help take off some weight. But they are actually designed as lifelong treatments for chronic diseases, namely obesity and Type 2 diabetes. 
    • “That distinction matters.
    • “While nearly 18% of U.S. adults have taken a GLP-1 drug for weight loss or to treat a chronic condition, about half of people will stop taking it within a year. Often, they don’t understand what is likely to come next. 
    • “Studies show that after stopping the drugs, people typically regain lost weight within about 1.5 years. And any improvements in blood sugar, blood pressure or cholesterol are reversed.
    • “People who take GLP-1s regain weight four times faster than those who lose weight through lifestyle interventions, according to a recent analysis published in the British Medical Journal.
    • “The depressing results raise the question: Are the drugs worth starting if you can’t stay on them long-term? Doctors largely say yes but caution the need for proper counseling and lifestyle changes.
    • “The medications, which include Ozempic, Mounjaro and Zepbound, mimic naturally occurring gut hormones such as GLP-1, suppressing appetite and making people feel full faster.”
  • Cardiovascular Business calls attention to five takeaways from new stroke guideline.
    • “The American Stroke Association (ASA), a division of the American Heart Association, has developed an updated ischemic stroke guideline that highlights the importance of coordinated care and expands patient access to critical treatments. The new document, published in full in Stroke, also includes the first detailed recommendations for treating stroke in pediatric patients.
    • “This update brings the most important advances in stroke care from the last decade directly into practice,” Shyam Prabhakaran, MD, MS, chair of the writing group behind the guideline and chair of the department of neurology at the University of Chicago Medicine, said in a statement. “New recommendations in the guideline expand access to cutting-edge treatments, such as clot-removal procedures and medications, simplify imaging requirements so more hospitals can act quickly, and introduce guidance for pediatric stroke for the first time.”
  • MedPage Today lets us know,
    • “Unhealthy alcohol use ranks among the top three causes of preventable deaths in the U.S., yet less than one-third of patients who visit a primary care clinician ever discuss alcohol use.
    • “A tailored practice facilitation strategy was linked to increased adoption of evidence-based screening and counseling for unhealthy alcohol use among adults at small and medium-sized primary care practices.
    • “Studies in two other states documented similarly positive findings.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance became the second major insurer to predict declining revenue in 2026 on Wednesday, as for-profit payers continue to shave off members to try and recover margins.
    • “The Indianapolis-based insurer estimated its operating revenue will drop by a low-single digit percentage next year. The guidance comes one day after UnitedHealth forecast an annual revenue decline for the first time in more than three decades, sparking a selloff of managed care stocks that continued into Wednesday.
    • “Elevance also projected adjusted diluted earnings per share of at least $25.50, compared to the $30.29 it posted in 2025. Analysts said the insurers are setting attainable guidance to rebuild investor confidence after a difficult few years for the sector.”
  • Cigna released on LinkedIn a white paper about the healthcare landscape facing employers this year.
  • Bio Pharma Dive notes,
    • “Eli Lilly is expanding its footprint in genetic medicine, announcing Wednesday an agreement with Germany-based startup Seamless Therapeutics to develop treatments for hearing loss. 
    • “The alliance gives Lilly access to a type of next-generation gene editing technology. Seamless engineers and programs “recombinases,” or enzymes that rearrange DNA, in such a way that they can precisely pinpoint and modify specific areas of the genome. Through the deal, Seamless will design certain recombinases to correct mutations in unspecified “genes of interest” in hearing loss, the companies said.
    • “Lilly didn’t specify how much guaranteed cash Seamless will receive initially. But the startup is eligible for over $1.12 billion in total payouts, which includes an upfront payment and a variety of unspecified milestones.
    • “The deal adds to a concerted push by Lilly, which recently flirted with a $1 trillion market value thanks to its diabetes and obesity medicines, into the field of genetic medicine.”  
  • Per Fierce Healthcare,
    • “Premise Health and Crossover Health plan to merge, creating a large employer-focused advanced primary care company serving more than 400 organizations and operating 900 clinics across the country.
    • “Both companies offer primary care and occupational health services for employers, unions, tribes and health plans with worksite or near-worksite clinics. The companies also offer virtual care services.
    • “Financial details of the agreement were not disclosed. The deal is subject to customary closing conditions, including regulatory approval.
    • “After closing, the combined company will approach $2 billion in annual revenue, according to a Premise Health spokesperson.”
  • and
    • “Reperio Health, a provider of at-home health screenings with instant results, is teaming up with Amazon One Medical to expand access to primary care. 
    • “This marks Amazon’s first partnership in the at-home preventive screening space. 
    • “Reperio was founded in 2020, working with employers to offer at-home health screenings with instant results. Now, it is launching ReperioCare, which adds an on-demand virtual visit with a contracted clinician to interpret those results. Employees using the service can then take advantage of an included One Medical membership for ongoing primary care. 
    • The partnership’s goal is to streamline the path from early detection to ongoing primary care, particularly in rural areas.” 
  • Per Beckers Hospital Review,
    • “Fort Wayne, Ind.-based Parkview Health has signed a letter of intent with Goshen (Ind.) Health to explore a partnership.
    • “The partnership would make Goshen Health Parkview’s largest hospital outside of Fort Wayne and establish it as a regional hub for care, access and growth, according to a Jan. 27 Goshen Health news release.
    • “Goshen and Parkview plan to collaborate to strengthen clinical services, expand care access and build a sustainable healthcare system. The process begins with a 90-day due diligence period, followed by regulatory review and final board approval.”
  • and
    • “Walmart has moved 3,000 of its pharmacy technicians into pharmacy operations team lead roles and expanded pay ranges for the workforce.
    • “Pharmacy technician hourly rates average $22, which can increase to $40.50 depending on location and certification, according to a Jan. 28 news release from Walmart. The 3,000 recently promoted pharmacy operations team leads receive an average hourly pay of $28 with the potential to earn up to $42 per hour. Walmart operates about 4,600 locations in the U.S.
    • “The two largest U.S. pharmacy chains by prescription dispensing revenue, Walgreens and CVS, have made similar investments in their pharmacy technicians. In April, Walgreens said it would pay for pharmacy employee’s prerequisite coursework for a PharmD degree. A few months later, CVS opened a workforce development center in Texas for pharmacy technicians, customer service representatives and other pharmacy employees.” 

Notable Obituary

  • The New York Times reports
    • “Thomas Fogarty, 91, Who Helped Revolutionize Vascular Surgery, Dies
    • “Drawing on his love of fly-fishing, he developed a balloon catheter that removes blood clots from patients’ limbs in a minimally invasive way. It has saved millions of lives.”
  • RIP

Tuesday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Republicans and the White House were trying to broker a last-minute deal Tuesday with Democrats who are demanding changes to immigration enforcement in a sprawling funding package, with an agreement seen as critical to averting a partial government shutdown.
    • “The Senate is set to consider a $1.3 trillion package of six spending bills, including one that would fund the Department of Homeland Security. Lawmakers need to send the measures to President Trump’s desk by the end of this week to avoid a funding lapse. Democrats have said they would pass five of the bills, but insisted on separating or reworking the DHS funding legislation, arguing that any changes to immigration enforcement must be written into law. 
    • “An administration official said the White House is offering to change its immigration-enforcement operations to get the final appropriations bills passed, pointing to steps already taken such as removing Border Patrol commander Gregory Bovino from Minneapolis. But the White House doesn’t want to alter the funding bills, the official said, seeing such a move by the Senate as effectively guaranteeing a shutdown this weekend by requiring the House—currently on recess until Monday—to take action.”
  • Fierce Pharma relates,
    • “Even as the Trump administration works to implement its “most favored nation” pricing system, the U.S. government continues to advance efforts to negotiate Medicare drug prices as enabled by the Inflation Reduction Act. 
    • “On Tuesday, the Centers for Medicare & Medicaid Services unveiled the next 15 high-spend medicines up for price negotiations under the program. 
    • “Meds up for first-time Medicare price negotiations this year include GSK’s inhaler Anoro Ellipta, Gilead’s HIV blockbuster Bitkarvy, AbbVie’s Botox and Botox Cosmetic brands, Takeda’s inflammatory bowel disease drug Entyvio and Johnson & Johnson prostate cancer medicine Erleada, according to a Jan. 27 release from the CMS.
    • “In addition, Novartis’ breast cancer medicine Kisqali, Eisai’s cancer therapy Lenvima, Lundbeck and Otsuka’s atypical antipsychotic Rexulti, Eli Lilly’s diabetes drug Trulicity and its breast cancer treatment Verzenio are also due up for first-time negotiations, according to the government.
    • “Rounding out the list are Roche and Novartis’ Xolair for food allergies, chronic hives and other uses, plus immunology biologics Cosentyx, Cimzia, Orencia and Xeljanz from Novartis, UCB, Bristol Myers Squibb and Pfizer, respectively.
    • “Also for the first time, the government will renegotiate a drug’s price under the IRA system, tagging Boehringer Ingelheim’s diabetes med Tradjenta for renegotiations. The drug was previously included in last year’s batch of pricing talks.”
    • “After the negotiation process for the drugs kicks off this year, their new Medicare prices will become effective in early 2028, according to the CMS. Drugmakers have until the end of February to decide whether to participate in the process.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced new guidance clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients — including Medicare and Medicaid enrollees — in a manner that’s low risk under the federal anti-kickback statute, so long as key safeguards are met. * * *
    • “The guidance, issued as a bulletin [PDF] by the HHS Office of Inspector General (OIG), supports efforts to make medically necessary drugs more affordable while protecting patients and federal health care programs from fraud and abuse. It also aligns with the Trump Administration’s broader effort to lower drug prices, increase transparency across the prescription drug market, and expand the availability of affordable direct-to-consumer pharmaceuticals as part of the TrumpRx program. * * *
    • “The guidance issued today provides pharmaceutical manufacturers with assurance that they may sell prescription drugs directly to patients who choose to pay cash — including patients enrolled in federal health care programs — when the arrangement meets specific conditions. These include ensuring the drug is not billed to Medicare, Medicaid, or other federal programs, is not used to market other federally reimbursable products, and is not tied to future purchases or referrals.
    • “Importantly, the guidance does not change the federal anti-kickback statute itself, which remains a criminal law enforced on a case-by-case basis. It also does not address financial relationships between manufacturers and other parties such as physicians, pharmacies, pharmacy benefit managers, or marketers. HHS OIG has indicated it will seek additional public input on those arrangements separately.”
  • Healthcare Dive tells us,
    • “The Trump administration’s top Medicare official is coming to the defense of the 2027 Medicare Advantage rate notice, after the rule sparked a wave of backlash from the health insurance sector.
    • “The CMS proposed a flat rate update for next year, which won’t adequately cover higher spending on seniors in the privatized Medicare program, insurers say. Regulators also proposed reforms to MA risk adjustment that would restrict insurers’ ability to inflate members’ risk scores and, correspondingly, their reimbursement from the federal government.
    • “The rule sent a shockwave down Wall Street, which had expected a much higher update from the historically pro-business Trump administration.”
  • Yesterday, CMS released proposed Medicare Part D payment policies for 2027. The American Hospital Association News notes,
    • “CMS plans updates to the Part D risk adjustment model. Out-of-pocket prescription drug costs for individuals with Medicare Part D are proposed to be capped at $2,400 in 2027, up from $2,100 in 2026. Comments on the [two] CY 2027 proposals are due Feb. 25. The agency expects to publish a final rate announcement on or before April 6.” 

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Amid a deregulatory push by the Trump administration, the Food and Drug Administration is scrutinizing its digital health policies. The agency suddenly issued a pair of guidances earlier this month, intended to clarify its approach to wellness devices and medical software. 
    • “The updates reflect changes to the agency’s thinking about what counts as a wellness device, but also raise new questions and pose challenges to consumers, experts said. 
    • “FDA Commissioner Marty Makary announced the pair of guidances — issued without any prior notice or public comment period — at the Consumer Electronics Show in early January. Makary said the agency has 27 different guidances that deal with software and digital health, and he aims to cut that number by at least half, while updating them to be more clear, modern and consistent.
    • “Despite Makary’s framing, attorneys viewed the updates as less of a major change to regulations, and more as tweaks and examples. 
    • “He was talking about cutting red tape and deregulating, and that’s not really what these are,” said Amanda Johnston, a partner at Gardner Law. “The law itself has not changed.” 
  • BioPharma Dive informs us,
    • “Shares for Intellia Therapeutics climbed by about 10% early Tuesday after the company said the Food and Drug Administration cleared it to resume one of two Phase 3 trials evaluating its experimental CRISPR-based treatment against the rare genetic disease transthyretin amyloidosis.   
    • “U.S. regulators halted two studies of Intellia’s nexiguran ziclumeran, or nex-z, last October following the occurrence of serious liver toxicity that resulted in the death of a trial participant. Intellia said Tuesday that the FDA has allowed it to restart “MAGNITUDE-2,” a trial testing nex-z in people with a form of the disease that affects the nerves, by incorporating new risk mitigation measures. It’s also enrolling about 10 more patients in that study. Intellia aims to begin testing again “as quickly as possible.” 
    • “Intellia also revealed, however, that a pause in the “MAGNITUDE” trial in patients with the “cardiomyopathy” form of the disease is ongoing. The company will provide an update once aligned with regulators on the program’s path forward there.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “The South Carolina measles outbreak has surpassed the recorded case count in Texas’ 2025 outbreak, as health officials have logged almost 600 new cases in just over a month.
    • “The outbreak centered in northwestern Spartanburg County is showing little sign of slowing down, with health officials saying Tuesday that 789 cases have been confirmed since September. Last year in Texas, 762 cases were reported, although experts believe that was likely an undercount.
    • “A large outbreak on the Utah-Arizona border is also ongoing, and the United States’ measles elimination status is at risk.”
  • ABC News informs us,
    • “Long-term alcohol use has been linked to higher risks of colorectal cancer, according to a study published Monday in the journal Cancer.
    • “Researchers found that those with heavy lifetime alcohol consumption have up to a 91% higher risk of developing colorectal cancer compared with those who drank very little. That risk significantly increased with consistent heavy consumption, whereas those who quit drinking may have demonstrated decreased risk of precancerous tissue.
    • “The longer someone drinks, the longer their colon and rectum are exposed damage and impaired repair, both major mechanisms of cancer,” Dr. Lynn M O’Connor, section chief of colon and rectal surgery at Mercy Medical Center and St. Joseph Hospital in New York, told ABC News.
    • “The study followed more than 88,000 adults with no prior history of cancer. Participants reported their alcohol use beginning in early adulthood and were followed for nearly a decade to track cancer outcomes.
    • “Compared with those who averaged one drink or less per week over their lifetime, those who consumed over 14 drinks a week had a 25% higher risk of developing colorectal cancer. The link was even stronger for rectal cancer, where one’s risk nearly doubled.”
  • and
    • “Reducing the sodium in pre-packaged and prepared foods may prevent thousands of cases of heart disease, stroke and death, according to two new studies.
    • “The studies, published early Monday in the journal Hypertension, took place in France and the United Kingdom, countries where food giants have subtly reduced salt levels in store-bought foods.
    • “Using national diet and health data, researchers in France estimated that modest decreases in bread salt content could cut adults’ daily salt intake by 0.35 grams, lower their blood pressure and prevent more than 1,100 deaths.
    • “Researchers from the U.K. estimated that similar salt reductions in packaged foods and takeout meals could lower daily British sodium intake by 17.5%, preventing more than 100,000 cases of heart disease and 25,000 cases of stroke over 20 years.
    • “Sodium plays important health roles, like helping blood vessels hold water. However, about 90% of Americans consume too much of it, according to the American Heart Association. Excessive sodium raises the risk of high blood pressure, a risk factor for issues such as cardiovascular disease, long-term kidney disease and cognitive decline.”
  • The New York Times considers whether “Intermittent Fasting Live Up to the Hype? The diet has been linked to weight loss, longer life span and even a lower risk of cancer — in mice. What about humans?” For example.
    • “The most common claim about intermittent fasting is that it’s a better way to lose weight than other diets. Early mouse and rat experiments suggested that something interesting was going on beyond simple calorie restriction. The animals lost weight and stayed healthier than mice that ate normally, no matter how many calories they binged between fasts.
    • “But in humans, the idea that intermittent fasts offer special weight loss benefits “really hasn’t been borne out by the data,” said James Betts, a professor of metabolic physiology at the University of Bath in the United Kingdom.”
  • Per an NIH news release,
    • “A study funded by the National Institutes of Health (NIH) provides the clearest evidence to date to link severe chronic traumatic encephalopathy (CTE) to dementia risk. CTE is a degenerative brain disorder in some people who have had repeated head impacts over time. It can only be diagnosed after death by examining brain tissue. While researchers were able to link severe CTE (stages III and IV) to dementia risk, they did not find any measurable link between less severe CTE (stages I and II) and changes in thinking, mood, or daily functioning.
    • “The research, led by scientists at Boston University CTE Center and the U.S. Department of Veterans Affairs Boston Healthcare System, analyzed 614 donated brains from people with known exposure to repetitive head impacts. None of the donors had Alzheimer’s disease, Lewy body disease, or frontotemporal lobar degeneration, three of the most common neurodegenerative diseases that cause dementia.”
  • NIH released its latest edition of Research Matters which covers the following topics:
    • “Testing risk-based breast cancer screening
      • “In a large clinical trial, risk-based breast cancer screening was as safe and effective as annual mammograms.
      • “This approach could help reduce anxiety, costs, and unnecessary follow-up testing.”
    • “ADHD medications stimulate alertness, motivation”
      •  “Researchers found that prescription stimulants for ADHD act on brain networks that control wakefulness and reward, but not attention as previously thought.
      • “The study suggests that stimulants and additional sleep affect the brain in similar ways, and that getting enough sleep could help in managing ADHD.”
    • “Cellular mitochondria transfer prevents pain”
      • “Studies in mice and human cells revealed that power-hungry sensory neurons get mitochondria for energy production from nearby supporting cells.
      • “The results point to potential new treatments for nerve pain caused by drugs or health conditions that harm mitochondria.”
  • Per MedPage Today,
    • “Postmenopausal women on the GLP-1 medication tirzepatide (Zepbound) for obesity lost more weight if they were also using menopause hormone therapy, a retrospective cohort study indicated.
    • “Among 120 women with overweight or obesity on tirzepatide, hormone therapy users lost 19.2% of their body weight, while those not using hormone therapy treatment lost 14% (P=0.0023), reported Maria Daniela Hurtado Andrade, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and colleagues.
    • “Women in the hormone therapy group lost 35% more body weight than those in the no hormone therapy group and showed notable improvements in key cardiometabolic parameters, supporting a potential enhancing effect of hormone therapy on tirzepatide’s therapeutic effect,” the researchers wrote in Lancet Obstetrics, Gynaecology, & Women’s Health.”
  • The Wall Street Journal points out,
    • “Roche ROG Holding said an experimental injection achieved positive results in a midstage clinical trial by helping patients shed weight, paving the way for the start of the company’s first late-stage obesity study.
    • “Eli Lilly and Novo Nordisk’s GLP-1 drugs currently dominate the obesity-drug market, but big drugmakers including Roche, Pfizer and Amgen, as well as smaller players, are trying to come up with new treatments to challenge them.” * * *
    • “The Swiss pharmaceutical company said Tuesday that a once-weekly injection of a drug candidate known as CT-388—one of its experimental drugs bought from Carmot—resulted in a weight loss of 22.5% when adjusting for placebo at 48 weeks.
    • “The reduction was achieved at the highest dose tested, 24 milligrams, without reaching a weight-loss plateau, the company said. Roche said 54% of trial participants on the 24 mg dose achieved resolution of obesity.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Wall Street believed the Trump administration was going to take a friendly approach to Medicare insurers. Now, investors think the industry might be in for a rough ride.
    • “Shares of big insurers plunged after The Wall Street Journal first reported that the Medicare agency was proposing 2027 Medicare insurer rates well below analysts’ expectations.
    • “UnitedHealth Group’s shares were down nearly 20% on Tuesday, while Humana’s dropped 21%. CVS Health and Elevance Health both fell 14%.”
    • “Among those large companies, $96 billion in market capitalization was wiped out Tuesday.” 
  • Beckers Payer Issues informs us,
    • “UnitedHealth Group reported fourth-quarter and full-year 2025 earnings Jan. 27. Profits took a hit, with the company attributing drops to Medicare funding reductions, the Inflation Reduction Act, steeper medical costs and remaining Change Healthcare cyberattack costs.”
  • Modern Healthcare adds,
    • “United Health Group plans to reduce Optum Health’s footprint by 20%.
    • “Optum Health will focus on its profitable segments as UnitedHealth Group navigates a multiyear recovery.
    • “Optum Health lost $278 million from operations in 2025. 
    • “Optum Financial Services will be incorporated into Optum Insight.”
  • Beckers Hospital Review lets us know,
    • “Nashville, Tenn.-based HCA Healthcare reported a net income of $6.8 billion in 2025, a 17.8% increase year over year, according to its Jan. 27 financial report.” 
  • and
    • “Healthgrades published its annual “America’s Best Hospitals Awards” Jan. 27, recognizing 250 hospitals across the country for strong quality performance.
    • “The list recognizes the top 50, 100 and 250 best hospitals, representing the top 1%, 2% and 5% of hospitals in the country for clinical excellence, respectively, the consumer platform said in a news release. For the ranking, Healthgrades analyzed clinical performance for 4,500 hospitals across 30 common procedures and conditions. It covers Medicare data from 2022 through 2024. Full details on the methodology can be found here.”
    • The article lists the top 50 hospitals organized by State.
  • Fierce Pharma informs us,
    • “Pfizer again heads up a physician ranking of vaccine manufacturers, beating Merck & Co. and Moderna to complete an unchanged top three from the last edition of the survey. But, while the rankings held steady, the operating environment has changed quickly to reinforce the value of being in good standing with physicians.
    • “ZoomRx generated the league table by asking 58 U.S.-based healthcare professionals (HCPs) about 14 vaccine manufacturers. Respondents graded the companies’ innovation, patient centricity, reputation, HCP centricity and promotions, generating data that ZoomRx used to give each manufacturer a score out of 100. 
    • “As happened when ZoomRx ran a similar survey in 2024, Pfizer took the top spot after achieving strong scores across all five dimensions. The Big Pharma scored 83 out of 100 after HCPs praised its innovation, reliability and sales execution in particular.”
  • Per MedCity News,
    • “Purchasers are increasingly seeking performance-based contracts — in which payment is tied to outcomes — with digital health solutions. However, implementing these contracts is difficult, especially for employers who have limited resources.
    • “That’s why the Peterson Health Technology Institute (PHTI) released a playbook last week for purchasers on how to effectively execute performance-based contracts. The playbook was created in collaboration with health plans, vendors, brokers, consultants, data warehouses and other stakeholders.
    • “We have consistently heard from both health plans and employers that the process of negotiating performance-based contracts remains very arduous. … We would really like to see purchasers coming to the table as a customer with high standards, we want to raise the bar on purchasing,” said Caroline Pearson, executive director of PHTI, in an interview. “Every payer should be holding their partners accountable for outcomes that really matter.”