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.”