FEHBlog

Tuesday report

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

From Washington, DC

  • The Hill reports,
    • “Top Democrats are whipping against the Department of Homeland Security (DHS) funding bill expected to come to the floor this week, even as Republicans press them to support it in the wake of the U.S. attacks on Iran. 
    • “The White House and Democrats have been locked in an impasse over a deal to reopen DHS, as the minority party calls for the administration to overhaul Immigration and Customs Enforcement (ICE) following the killings of two U.S. citizens in Minnesota by federal agents.” 
  • Per a CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) released Medicare.gov Enhanced Login options. By providing people with Medicare these options, Medicare.gov is helping users better manage their health care information by delivering more login choices. People with Medicare do not need to create an account to access general Medicare information or their individualized Medicare information. If someone chooses to create an account, Medicare is providing new and free options with enhanced security to help protect their Medicare information.”
  • Beckers Payer Issues adds,
    • “Medicare Advantage plans looking to maintain no-premium models could face 50% cuts to supplemental benefits and $1,000 more in older adults’ cost exposure in 2027, according to February reports commissioned by health insurance trade association AHIP.
    • “Wakely Consulting Group conducted the research. The groups evaluated how CMS’ proposed 0.09% 2027 payment increase for MA would play out for insurers and their beneficiaries. AHIP sent the findings to CMS in a Feb. 25 letter.”
  • The Paragon Health Institute notes,
    • “The [Medicare] primary base hospital payment rate for inpatient services—known as the Inpatient Prospective Payment System (IPPS) operating base rate—has increased by 30 percent since 2016, mainly because of statutory formulas.  The outpatient services base rate—known as the Outpatient Prospective Payment System (OPPS) conversion factor—has increased by 26 percent since 2016, also mainly because of statutory formulas. Meanwhile, the physician base payment rate—known as the Physician Fee Schedule (PFS) conversion factor—has declined by 7 percent over the same period.
    • “The declining PFS conversion factor and the rising hospital base rates are not an accident but a result of policy choices made by Congress.” * * *
    • “To reduce distortions, hospital payments in Medicare should be subject to similar fiscal sustainability pressures as physician payments. Policymakers should consider proposals that address distortions and, in particular, site neutral payment policies that equalize payments for the same services across all providers.” 
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted a Special Report on Entyvio® (vedolizumab, Takeda Pharmaceutical Co. Ltd.) for the treatment of ulcerative colitis and Crohn’s disease. This report will be submitted to the Centers for Medicare & Medicaid Services (CMS) as part of the 2026 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2028. 
    • “Downloads: Final Report
    • “Over three million people in the United States suffer from inflammatory bowel diseases like ulcerative colitis and Crohn’s disease. Our special report focuses on the medical evidence for and value of Entyvio, which is commonly used to treat both conditions,” said ICER’s President and CEO Sarah K. Emond, MPP. “We recognize that our report will be one of many inputs CMS may consider, and we hope that it will support their ongoing efforts to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced Kurt Dykstra as General Counsel.
    • “Dykstra is an accomplished attorney with nearly three decades of experience handling complex workforce issues, regulatory compliance, internal investigations, and governance. His career spans corporate law, higher education, financial services, and public service, including leadership roles as a law firm shareholder, university counsel, college president, bank executive, mayor, and Major in the US Army Reserve.
    • “As OPM’s Chief Legal Officer, Dykstra will lead the Office of the General Counsel and advise the director and agency leadership on legal and policy matters.
    • “Kurt is a proven leader with the judgment and experience to help guide OPM through complex legal and workforce challenges,” said OPM Director Scott Kupor. “He understands how strong governance, accountability, and sound legal strategy support effective government. I am confident his leadership will help ensure OPM continues to serve federal employees and the American people with integrity and excellence.”
  • The Wall Street Journal relates,
    • “Patient Advocate Foundation and Patient Access Network Foundation merged, creating a nonprofit with over $800 million in assets.
    • “Kevin Hagan is chief executive of the combined Patient Advocate Foundation, which aims to serve patients facing rising costs.
    • “The combined foundation will launch a TotalAssist program in July and offer more than 130 disease-specific financial assistance funds.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration has been talking a big game about bringing artificial intelligence to patients. In January, when it announced relaxed rules for certain AI products, Commissioner Marty Makary said the agency is “developing a new regulatory framework for AI.” 
    • “How the agency will regulate rapidly-evolving uses of generative AI is one of the big questions facing health technology developers. Large language models’ wide-ranging applications evade simple measures of safety and efficacy, challenging the FDA’s longstanding approach to device validation — and the agency has yet to authorize a device that relies on generative AI. But a recent breakthrough designation from the FDA could offer hints about its approach to regulating patient-facing chatbots that fall under its purview. 
    • “In November, the FDA quietly handed one of its breakthrough device designationsto a chatbot for patients recovering from joint replacement surgery. Under development by RecovryAI, which is coming out of stealth as it announces the designation, the LLM-powered device would be prescribed to patients to use in the 30 days after surgery. It will encourage them to check in twice a day about their sleep, activity, diet, and other elements of recovery, answering questions and escalating to a care team when necessary.” 
  • Radiology Business adds,
    • “An artificial intelligence-enabled tool capable of accurately predicting an expectant mother’s delivery date has received the U.S. Food and Drug Administration’s De Novo clearance. 
    • “Ultrasound AI—a company that specializes in medical imaging AI applications—on Monday announced the clearance of its flagship Delivery Date AI technology. The product is a cloud-based software as a medical device that predicts delivery dates using ultrasound imaging alone. This could help to better prepare both patients and providers for potential complications, reducing the likelihood of preterm birth. 
    • “It was trained on a diverse dataset of over 1 million ultrasound images and evaluated via a peer-reviewed study, published in the Journal of Maternal-Fetal & Neonatal Medicine. The study, which included nearly 6,000 patients, determined AI could achieve an accuracy of 0.92 R² value for predicting the day a mother would deliver her child using only standard ultrasound images. 
    • “Delivery Date AI can be easily integrated into most ultrasound systems. Ultrasound AI indicates that installation takes just a few minutes and offers organizations scalability while also potentially reducing long-term costs by improving maternal outcomes.” 
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. 
    • “It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”
    • “This is the second group of warning letters sent to telehealth firms since the agency launched in September a crackdown on misleading direct-to-consumer pharmaceutical advertisements. Over the past six months, the agency has sent thousands of letters warning pharmaceutical and telehealth firms to remove misleading ads, more than had been sent over the entire preceding decade.”
  • Per BioPharma Dive,
    • “Pierre Fabre Pharmaceuticals has asked the Food and Drug Administration for an urgent meeting to discuss why the agency rejected a cell therapy for a post-organ transplant malignancy, the company said Tuesday, following claims by partner Atara Biotherapeutics that the agency contradicted its previous guidance.” * * *
    • “The regulatory dispute over Ebvallo is one of a series of recent squabbles between drugmakers and the FDA related to previous agreements on approval standards. On Monday, UniQure learned it will have to conduct another trial of a Huntington’s disease gene therapy. Last month, the agency initially refused to review a flu vaccine from Moderna before quickly changing course.”

From the judicial front,

  • Medical Economics tells us,
    • “Advanced analytics and multi-agency coordination are shortening investigative timelines and expanding parallel civil FCA, criminal, administrative, and state litigation exposure from a single operational issue. 
    • “Enterprise-level FCA theories are emphasizing systems, governance, and vendor relationships, with sustained focus on managed care, prescription drugs, and medically unnecessary services. 
    • “Medicare Advantage risk adjustment scrutiny is extending to incentive design, retrospective addenda, chart review vendors, and documentation tools that may be construed as rewarding coding intensity. 
    • “Telehealth platforms face continued controlled-substance risk despite extended prescribing flexibilities, with enforcement targeting clinical legitimacy, marketing representations, cross-state compliance, and decision-making controls. 
    • “Cybersecurity and privacy failures are becoming enforcement multipliers via FCA cyber-fraud theories, CCPA actions, and HIPAA tracking-technology scrutiny involving adtech and analytics data sharing.”
  • STAT News reports,
    • “Moderna has agreed to pay Roivant up to $2.25 billion to settle claims that the mRNA vaccine developer infringed on Roivant’s patents in its Covid-19 shot.
    • “Roivant will receive $950 million and then another $1.3 billion if Moderna’s attempts to have parts of its liability offloaded to the federal government fail upon appeal. If the full amount is paid, it will be among the largest patent settlements in history. 
    • “It is probably the largest ever,” said Jacob Sherkow, a professor of law and medicine at the University of Illinois Urbana-Champaign.
    • “The settlement comes less than a week before the two companies were set to go to a jury trial in Delaware, where legal experts say Moderna may have faced an uphill battle.\

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • To live long, be strong.
    • That’s the poetic implication of a new study of longevity and mortality in a large group of women aged 63 to 99.
    • “In the study, published in February in JAMA Network Open, researchers checked the women’s health, fitness, grip strength and lifespans. By analyzing that data, they hoped to tease out the importance of muscular strength for healthy aging.
    • “The results “were a bit of a surprise,” said Michael J. Lamonte, lead author of the study and a professor of epidemiology and healthy aging at the University of Buffalo in New York. Strength turned out to be a key — and singular — contributor to longer lives, he said, reducing the risk for early death by a third or more, even when the researchers took into account people’s aerobic fitness, health, age and exercise habits.”
  • The American Medical Association lets us know what doctors wish their patients knew about cystic fibrosis.
  • MedPage tells us,
    • “A meta-analysis found that women lost more weight than men while taking a GLP-1 receptor agonist.
    • “Biological differences, such as estrogen levels and body composition, may explain why women respond more to these agents.
    • “Weight loss was consistent across many other patient subgroups broken down by age, race and ethnicity, body mass index, and HbA1c.”
  • and
    • “Lithium carbonate might have slowed decline in verbal memory in a pilot study.
    • “However, the treatment did not meet a prespecified threshold for the trial’s primary outcomes.
    • “Earlier research suggested lithium may offer neuroprotective benefits in Alzheimer’s and dementia.”
  • Genetic Engineering and BioTechnology News points out,
    • “Immune monitoring is useful to monitor processes like vaccination and during diseases like infectious disease, cancer, and autoimmunity. However, detection of antigen-specific lymphocytes is challenging given that are low in frequency and have a dispersed distribution.
    • “Now, the first bandage-like, painless, microneedle patch that can sample the body’s immune responses from the skin has been developed. The device detects inflammatory signals within minutes and collects specialized immune cells within hours without the need for blood draws or surgical biopsies.
    • “The study appears in Nature Biomedical Engineering in the paper, “Leveraging tissue-resident memory T cells for non-invasive immune monitoring via microneedle skin patches.”
    • “The patch is helping researchers and clinicians study immune responses in aging and skin autoimmunity, including vitiligo and psoriasis. In the future, it could make it easier to track how people respond to vaccines, infections, and cancer therapies by complementing traditional blood tests and biopsies while being far easier on patients.”
  • Per BioPharma Dive,
    • “Shares of Aardvark Therapeutics lost more than half their value after safety worries led the biotechnology company to halt testing of its most advanced drug prospect. 
    • “Aardvark said Friday that, “out of an abundance of caution,” the company has voluntarily paused dosing and enrollment in a Phase 3 trial of ARD-101, an experimental drug it’s been developing for the rare genetic disease Prader-Willi syndrome. According to Aardvark, trial monitors detected “reversible cardiac observations” during a routine safety check in a study of healthy volunteers.” 
  • and
    • “Kyowa Kirin will stop all trials of an eczema drug once seen as a possible future blockbuster, claiming a new safety review has led the company to believe that the treatment’s risks may outweigh its benefits.
    • “In a Tuesday statement, the company said a planned evaluationconducted by the company and former development partner Amgen in recent weeks unearthed “emerging concerns of malignancies” related to treatment with a therapy known as rocatinlimab. These concerns included one new confirmed case and another suspected case of Kaposi’s sarcoma, a cancer that forms around skin lesions.”
    • “The findings suggest a potential link between onset of the cancer and the drug’s mechanism of modulating an immunogical pathway called OX40. While the overall number of cases is below expected background rates, the “characteristics” involved “raised a plausible biological concern that cannot be excluded,” the company said.
    • “All studies will be discontinued after study participants complete their required safety follow-up visits, Kyowa Kirin added.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Rochester, Minn.-based Mayo Clinic recorded an income from current activities of $1.5 billion (6.8% margin) in 2025, up from $1.3 billion (6.5% margin) in 2024.”
  • and
  • and
    • “Nacogdoches County Hospital District in Nacogdoches, Texas, unanimously approved a new lease agreement with Dallas-based Tenet Healthcare on Feb. 27, The Nacogdoches Daily Sentinel reported March 2.
    • “The 15-year lease agreement designates Nacogdoches Memorial Hospital and Cecil R. Bomar Rehabilitation Center as campuses of Nacogdoches Medical Center. Tenet, which operates Nacogdoches Medical Center, will assume daily operations of Nacogdoches Memorial Hospital.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare and Ascension are planning competing freestanding emergency departments in Fairview, Tenn., a fast-growing community in western Williamson County.”
  • Fierce Healthcare tells us,
    • “Health systems interested in preserving their operating margins will need to be proactive in addressing a growing minority population responsible for an outsized share of care utilization: patients with multiple chronic conditions. 
    • “In a newly released analysis of 2025 claims data, Vizient found that 11% of the U.S. population with multiple chronic conditions accounted for 52% of inpatient admissions. These patients also represented 35% of emergency department visits and 32% of office visits.
    • “To put it another way—compared to those without any chronic disease, these patients have about 10 times more inpatient admissions and ED visits, as well as six times as many office visits. Further, ED and office visits among those with multiple chronic conditions are projected over the next decade to grow at nearly double the rate of those with a single chronic condition, who are also higher care utilizers.
    • These patients pose a major financial challenge for providers due to their unfavorable payer mix. Specifically, Vizient found that 72% of inpatient admissions for those with multiple chronic conditions were covered by Medicare and another 10% by Medicaid. 
  • and
    • “Grow Therapy, a hybrid mental health provider, has clinched $150 million to build out physician and employer relationships.
    • “The series D round was led by TCV and Growth Equity at Goldman Sachs Alternatives, with participation from new investors BCI and Menlo Ventures. 
    • ‘Physicians and employers are newer customer types for Grow but have been the focus of the platform’s growth over the past five years. The capital will also be used to strengthen the tech powering Grow and enhance the user experience for patients, therapists and other partners.
    • “Grow has amassed a range of partners that today includes 125 payers, provider groups like Circle Medical, health systems like Kaiser Permanente and employers. Primary care docs are of particular focus to Grow right now, given they deliver 60% of the nation’s mental healthcare.” 
  • MedTech Dive informs us,
    • “RadNet has struck a 230 million euros deal to buy radiology artificial intelligence company Gleamer.
    • “The takeover, which the companies disclosed Monday, gives RadNet control of devices that are used in more than 25 indications and are forecast to generate about $30 million in annualized recurring revenue this year.
    • “Buying Gleamer will expand the capabilities RadNet acquired through the DeepHealth buyout in 2020, particularly in X-ray, and accelerate its expansion outside the U.S. Gleamer will be integrated into DeepHealth, a full-owned subsidiary of Radnet.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “Republicans are renewing their push to fully fund and reopen the Homeland Security Department, suggesting the war the United States launched against Iran over the weekend has heightened the need to end the single-agency shutdown that entered its third week on Monday. 
    • “House Republicans will bring up another vote on a DHS appropriations bill this week, Majority Leader Steve Scalise, R-La., announced, saying it was dangerous for Democrats to continue holding up the funding due to concerns over the Trump administration’s immigration enforcement crackdown. 
    • “The legislation would “end the DHS shutdown so we can ensure agencies can protect America during this dangerous time,” Scalise said, noting the FBI has warned of an elevated threat of terrorist activity domestically.” * * *
    • “Most of the department’s employees have continued to work during the shutdown, with only about 8% of the workforce home on furlough. Many employees, such as law enforcement and other personnel at Immigration and Customs Enforcement and Customs and Border Protection, are receiving their normal paychecks thanks to funding Congress provided in the One Big Beautiful Bill Act. Others, such as Transportation Security Administration and Federal Emergency Management Agency workers, have started to receive partial paychecks or will do so this week. The U.S. Coast Guard is paying its uniformed personnel on time, but civilians will face delayed pay.” 
  • Healthcare Dive relates,
    • “The American Medical Association is overhauling how U.S. doctors report and bill for pregnancy services, bulldozing the current system of bundled payments and replacing it with more granular, itemized codes next year.
    • “The changes, shared exclusively with Healthcare Dive, could help improve poor maternity health outcomes in the U.S. But it’s also an acquiescence to specialty groups, which have long lobbied the powerful medical association that modern obstetric services are more complex than the current coding system is able to reflect.
    • “The move also represents a step back for value-based care, and could incentivize OB-GYNs and other doctors to provide unnecessary medical services at a time of skyrocketing health spending.
    • “But the changes shouldn’t result in OBGYNs, nurse-midwives or other maternity care specialists bringing in more revenue, according to the AMA, which argues the new coding system will benefit the entire healthcare industry.” * * *
    • “Global codes are normally billed when a baby is delivered, which can keep insurers in the dark about their members’ pregnancies. The new codes should give insurers more information, including when a member gets pregnant, that could help them ensure expecting mothers get adequate prenatal care, or know if mothers had complications during delivery that could necessitate follow-up services, according to Dr. Daniel Halevy, an executive at New York nonprofit insurer Healthfirst.”
  • and
    • “Sweeping reforms in the Consolidated Appropriations Act of 2026, signed into law by President Donald Trump earlier this month, included changes that could upend the traditional PBM model, while also turning attention back to drugmakers.” * * *
    • “With PBMs’ bargaining power facing stricter limits under the new reform [which takes effect later this decade to allow for necessary rulemaking], questions surrounding pricing could shift in a new direction.
    • “Be ready for the spotlight to swing back to drug manufacturers,” said Jesse Dresser, a partner in law firm Frier Levitt’s life sciences department and head of its pharmacy practice group.
    • “As PBMs lose traction in the coming years, the pressure on drugmakers to justify their own list prices could intensify.
    • “Now, the argument is going to be that PBMs have been handcuffed, limiting their ability to use some of these abusive tools,” Dresser suggested. “So, it’s going to be up to the drug manufacturers to make sure they’re taking the appropriate steps and not continuing in the old paradigm now that there should be a shift in financial incentives.”
  • Bloomberg Law reports,
    • “A group representing thousands of pharmacies across the US said its members are experiencing financial issues after the rollout of the government’s drug price negotiation program, urging the Centers for Medicare & Medicaid Services to immediately address cash flow concerns.
    • “A letter from the National Community Pharmacists Association is asking CMS Administrator Mehmet Oz to ensure pharmacies receive timely payments under the Medicare Drug Price Negotiation Program, finding in a survey that its members are facing cash flow issues after dispensing certain drugs and waiting for a refund from the manufacturer. 
    • “We need CMS to take all necessary steps to expedite the manufacturers’” refund payments to pharmacies, Ronna Hauser, senior vice president of policy and pharmacy affairs for NCPA, said in the letter to the CMS sent Thursday. “Pharmacies cannot continue to dispense these drugs with delayed payments unless the cash flow issues significantly improve.”
  • Per an Employee Benefits Research Institute news release,
    • “Rising health care costs are affecting household finances for many privately insured adults, with 4 in 10 reporting higher expenses in the past year and many cutting discretionary spending or reducing retirement contributions, according to results from the 2025 EBRI/Greenwald Research Consumer Engagement in Health Care Survey (CEHCS) released today by the Employee Benefit Research Institute (EBRI).
    • “Employment-based coverage remained the dominant source of private insurance, with 6 in 10 covered through their own job. Deductibles also remained widespread across plan types: More than three-quarters of enrollees had a medical deductible, including 70% of traditional plan enrollees. Enrollment in high-deductible health plans dipped slightly in 2025, while enrollment in consumer-directed health plans and health savings accounts (HSAs) appeared relatively stable.
    • “The annual survey also found that most enrollees spent relatively little time selecting coverage during open enrollment, with about half spending less than an hour reviewing options and most spending under two hours. While most adults reported being satisfied with the ease of plan selection and the information available, satisfaction with the availability of affordable plan options and the number of plans to choose from declined in 2025.”
  • Beckers Payer Issues tells us,
    • “CMS is sanctioning Elevance Health and plans to suspend enrollment into the insurer’s Medicare Advantage prescription drug plans, according to a Feb. 27 agency letter.
    • ‘The enrollment and communications pause is set to begin March 31 unless Elevance submits all data corrections and an attestation in advance. CMS said the intermediate sanctions stem from “substantial and persistent noncompliance with Medicare Advantage risk adjustment data submission requirements.” The sanctions will apply until Elevance resolves the issues.”
  • Per a Labor Department news release,
    • “The U.S. Department of Labor’s Wage and Hour Division announced [February 26] a proposed rule designed to help workers and employers better understand how to determine when a worker is an employee and when the worker may be classified as an independent contractor under the Fair Labor Standards Act and related federal laws. 
    • The proposed rule would rescind the department’s 2024 final rule addressing the classification of independent contractors and replace it with an analysis for employee classification similar to the one adopted by the department in 2021. Consistent with Supreme Court and federal circuit court precedent, the proposed rule would make it easier to properly differentiate between employees with the protections under the Fair Labor Standards Act and those workers who work as independent contractors.” * * *
    • “The department encourages all interested parties to submit comments on the proposed rule, which has a 60-day comment period that closes at 11:59 p.m. ET on April 28, 2026.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Ascendis Pharma said Friday the Food and Drug Administration granted accelerated approval to a treatment it’s developed for the most common type of dwarfism, ending what had been a monopoly for rival drugmaker BioMarin Pharmaceutical. 
    • “The new drug, previously known as TransCon CNP and now Yuviwel, is a once-weekly injection cleared for children aged two and older with achondroplasia and open growth plates. The treatment will compete with Voxzogo, a daily shot sold by BioMarin.”
  • MedTech Dive relates,
    • “Abbott has won approval for updated remote heart failure monitoring technology, the company said Friday.
    • “The Food and Drug Administration awarded approval to CardioMEMS Hero, a new version of the device that patients use to take daily pulmonary artery pressure readings.
    • “Abbott has made Hero smaller and 60% lighter than the previous reader, fitting the electronics into a device the size of a laptop case to make it easier to use and take on planes.”
  • and
    • “Unomedical, a subsidiary of Convatec and a supplier of insulin infusion sets to diabetes tech firms, received a warning letter from the Food and Drug Administration in January.
    • “Inspectors raised concerns with leaking infusion sets, which can pose a risk of insulin under-delivery, potentially leading to life-threatening complications like diabetic ketoacidosis.  “Regulators called for Unomedical to address problems with validating its devices, addressing complaints and providing timely adverse event reports to the FDA.
    • “The warning letter followed a remote regulatory assessment of Unomedical’s facility in Reynosa, Mexico, last summer.”

From the judicial front,

  • Bloomberg Law reports,
    • “The Justice Department said it won’t appeal the decision of a New York federal judge to throw out a murder charge against Luigi Mangione, which means he won’t face the death penalty if he’s convicted of killing UnitedHealth Group Inc. executive Brian Thompson.
    • “US District Judge Margaret Garnett ruled in January that prosecutors can’t pursuethe capital murder charge, but that a jury could determine if Mangione caused Thompson’s death under two federal stalking laws. If convicted of those crimes, he could face life in prison without possibility of parole. 
    • “In a one-page letter Friday to Garnett, a Justice Department lawyer said prosecutors won’t challenge the judge’s decision.” 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A report published March 2 by the American Cancer Society found that colorectal cancer rates among adults 65 and older continue to decline while rates for younger adults continue to increase. The study found that the increase is being driven by a higher prevalence of rectal cancer, which now makes up 32% of all colorectal cancer diagnoses, up from 27% in the mid-2000s. The study also projects 158,850 new cases of colorectal cancer in the U.S. in 2026, and that 55,230 individuals will die from the disease. Nearly one-third of deaths are estimated to be younger than age 65.” 
  • Cardiovascular Business tells us,
    • “Patients with type 2 diabetes who use GLP-1 receptor agonists (GLP-1 RAs) and make healthy lifestyle choices can significantly lower their risk of experiencing a heart attack or stroke, according to new data published in The Lancet Diabetes & Endocrinology.[1]
    • The study’s authors explored data from more than 98,000 participants from the U.S. Department of Veterans Affairs’ Million Veteran Program. These individuals were enrolled from 2011 to 2023. 
    • “Lifestyle habits explored in this analysis included getting a recommended amount of exercise, not smoking, sleeping well, drinking minimal alcohol, properly managing stress, connecting with others socially and avoiding opioids. Overall, adults on a GLP-1 RA and following six to eight of these healthy habits was associated with a 43% lower risk of experiencing a major adverse cardiovascular event (MACE) than those not taking GLP-1 RA or adhering to these habits. When adults followed all eight habits, meanwhile, the risk was approximately 60% lower.
    • “In addition, those using a GLP-1 RA had a 16% lower MACE risk than those who did not use a GLP-1. 
    • “Our findings underscore that, even in the era of highly effective GLP-1 pharmacotherapy, lifestyle habits remain central to diabetes management and cardiovascular risk reduction and can substantially amplify the benefits of modern medications,” corresponding author Frank Hu, MD, PhD, chair of the department of nutrition at the Harvard T.H. Chan School of Public Health, said in a statement.”
  • Contemporary OB/GYN informs us,
    • “The quadrivalent HPV vaccine is associated with a significantly reduced risk of invasive cervical cancer that persists for at least 18 years after administration.
    • “Vaccination before the age of 17 provides a 79% lower risk of cervical cancer, while those vaccinated at age 17 or older also experience significant long term risk reductions.
    • “Population level data shows that school based vaccination cohorts have significantly lower rates of invasive cervical cancer compared to earlier opportunistic vaccination cohorts.”
  • MedPage Today points out,
    • “The location and amount of brain microbleeds that a person has could be telling of their risk of dementia, according to an observational analysis.
    • “Compared with controls with no cerebral microbleeds detected on MRI, there was an increased dementia risk in older people with:
      • “Mixed subcortical and lobar microbleeds (HR 1.99, 95% CI 1.40-2.83)
      • “Lobar-only microbleeds, with or without cortical superficial siderosis (HR 1.96, 95% CI 1.30-2.97)
      • “Any cortical superficial siderosis (HR 2.57, 95% CI 1.36-4.89)
    • “Participants with three or more cerebral microbleeds of any pattern also had an increased risk of dementia (HR 1.92, 95% CI 1.35-2.72), as did peers with at least two subcortical microbleeds, according to Rebecca Gottesman, MD, PhD, of the National Institute of Neurological Disorders and Stroke in Bethesda, Maryland, and colleagues.
    • “Their report, based on the Atherosclerosis Risk in Communities-Neurocognitive Study, was published in Stroke.
  • and
    • “Chronic migraine patients who used GLP-1 receptor agonists to treat conditions like obesity or diabetes had fewer emergency department (ED) visits than those on topiramate (Topamax), a real-world data analysis showed.
    • “Compared with topiramate users, GLP-1 drug initiators were 10% less likely to visit the ED over the following year (RR 0.90, 95% CI 0.86-0.94), reported Hsiangkuo Yuan, MD, PhD, of Jefferson Headache Center at Thomas Jefferson University in Philadelphia, in an abstract released ahead of the American Academy of Neurologyopens in a new tab or window annual meeting.”
  • The Wall Street Journal asks whether Multi-Cancer Blood Tests Are Ready for Prime Time?
    • Early detection tests are already on the market, but without FDA approval or proof they reduce deaths some doctors urge caution
  • Per BioPharma Dive,
    • “Roche’s experimental pill fenebrutinib hit its main goal in a second Phase 3 trial in the most common form of multiple sclerosis, helping treatment recipients experience significantly fewer relapses than study volunteers who got Sanofi’s Aubagio, the company said Monday.
    • “However, Roche also reported a case of severe liver side effects in one enrollee who got fenebrutinib in the study. It also revealed a higher number of deaths among people who took its therapy in the two Phase 3 trials in relapsing MS, which prompted one analyst, Michael Leuchten of Jefferies, to question the drug’s approval prospects. Analysts have forecasted peak sales of more than 3 billion Swiss francs, or $3.8 billion, for fenebrutinib, Leuchten wrote.
    • “Fenebrutinib is part of a new crop of “BTK inhibitors” that drugmakers are now positioning as potential autoimmune disease treatments. The effort has yielded multiple setbacks in MS, though, as the Food and Drug Administration recently rejected a BTK drug from Sanofi, and other developers like Merck KGaA and Biogen have given up on prospective drugs.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “UnitedHealth Group has named Dennis Stankiewicz as chief accounting officer, effective March 2. 
    • “Tom Roos, who has served as CAO since 2015, has been named CFO at Optum Insight, the company said in regulatory filings.”
  • Healthcare Dive adds,
    • “UnitedHealth executive and former Optum leader Heather Cianfrocco is leaving the company, according to a post on LinkedIn.
    • “Cianfrocco was promoted to executive vice president of governance, compliance and information security at UnitedHealth in May, after serving for a year as CEO of Optum, the company’s health services arm. Patrick Conway, the former CEO of Optum Rx, replaced Cianfrocco.
    • “Cianfrocco is departing UnitedHealth after serving in a number of executive positions, including as CEO of Optum Rx and chief of UnitedHealthcare’s community and state division. “After 24 years, I am saying goodbye to the team at UnitedHealth Group,” she said in a post on LinkedIn. “I am leaving with so much pride in what we have accomplished together.”
  • Beckers Hospital Review notes,
    • “According to data gathered by Becker’s, Parkland Health and Hospital System [in Dallas, Texas] saw the highest number of emergency department visits in 2025. 
    • “The figures [shown in the article] represent the number of ED visits at individual hospital facilities, rather than the total visits across entire health systems. These self-reported totals were provided directly by hospitals.
  • Fierce Healthcare relates,
    • “Healthcare technology companies DoseSpot and Arrive Health have merged to combine an electronic prescribing platform with medical and pharmacy benefits data to advance real-time medication price transparency for providers and patients.
    • “The new company, called Interra Health, combines Arrive Health’s coverage and pricing network with DoseSpot’s e-prescribing capabilities to support prescribing decisions and help patients access the right medication at the lowest cost, according to the companies.
    • “Bain Capital Tech Opportunities is backing the deal and will serve as majority owner. PSG, the former majority owner of DoseSpot, will be a minority owner. Additional minority investors include Providence and UPMC Enterprises.
    • “The combined company is profitable, growing at approximately 40% annually and projected to exceed $100 million in revenue in 2026, executives said.”
  • Per BioPharma Dive,
    • “Privately held Candid Therapeutics will merge with Rallybio in a deal to take the inflammatory disease drugmaker public, the companies said Monday.
    • “The new entity will operate under Candid’s name, and trade on Wall Street under the ticker “CDRX.” As part of the deal, Candid raised $505 million from more than a dozen venture capital firms and mutual funds including Venrock, RA Capital Management and Janus Henderson Investors.
    • “Candid is developing bispecific antibodies known as T-cell engagers it acquired in two deals with Chinese biotechnology firms in 2024. One of Candid’s central goals is to show it can advance drugs that are similar to cell therapies targeting B cells, but easier to manufacture and administer. While bispecifics research has largely focused on cancer, startups like Candid — and even some pharmas — are now testing the applicability of these drugs against autoimmune conditions.”

Weekend update

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

From Washington, DC,

  • Roll Call previews Congress’s agenda for this week here.
  • Of note,
    • Senate Committee on Health, Education, Labor, and Pensions
    • 10:00 AM (EST) – Senate | 430 Dirksen Senate Office Building, Washington, D.C.
    • Meeting: Hearings to examine transforming health care with data, focusing on improving patient outcomes through next-generation care.
    • Meeting Details
  • Per a February 27, 2026, HHS news release,
    • The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) today announced the appointment of two new members to the CDC Advisory Committee on Immunization Practices (ACIP).
    • The two new members are:
      • Sean G. Downing, M.D., physician specializing in Internal Medicine and Pediatrics, and
      • Angelina Farella, M.D., pediatrician and owner of A Brighter Tomorrow Family Health and Wellness in Webster, Texas.

From the judicial front,

  • Per a February 27, 2026, Justice Department news release,
    • “Atlanta Gastroenterology Associates located in Atlanta, Georgia, has agreed to pay $4.75 million to resolve allegations that it violated the False Claims Act by receiving kickbacks in exchange for referrals of gastrointestinal pathology services and by performing certain gastrointestinal pathology services that were not medically reasonable or necessary.
    • “The United States alleged that beginning in approximately May 2017, Atlanta Gastroenterology Associates contracted with Advanced Pathology Solutions (APS), a pathology laboratory located in Little Rock, Arkansas, to construct and operate a limited-capacity pathology laboratory in Atlanta Gastroenterology Associates’ office. Atlanta Gastroenterology Associates received various benefits from APS in connection with the setup and ongoing operations of the in-house lab, in which histology technicians prepared and stained specimen sample slides and Atlanta Gastroenterology Associates billed Medicare and other insurers for the technical component of those services. In exchange, Atlanta Gastroenterology Associates agreed to exclusively refer patients to APS, which interpreted the slides and billed for the professional component of the services. The United States alleges that the benefits provided by APS to Atlanta Gastroenterology Associates were unlawful remuneration in exchange for patient referrals.” * * *
    • The claims resolved by the settlement are allegations only and there has been no determination of liability.

From the public health and medical / Rx research front,

  • Health Day reports,
    • “Some Great Value cottage cheese products sold at Walmart are being recalled because they may not have been fully pasteurized, Saputo Cheese USA said.
    • “The recall affects select cottage cheese products made between Feb. 17 and 20, and sold in the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Missouri, Mississippi, Montana, New Mexico, Nevada, Oregon, Texas, Tennessee, Utah, Washington and Wyoming, the U.S. Food and Drug Administration (FDA) reported.
    • “No illnesses or hospitalizations have been reported so far.
  • Medscape tells us,
    • “Age-adjusted rates of cardiovascular disease (CVD) mortality tripled from 3.4 to 10.34 per 100,000 people between 1999 and 2023 among US adults with obesity, with higher rates observed in men, older adults, non-Hispanic Black adults, and in the South.”
  • and
    • “Most Americans with obesity perceive themselves as only having overweight regardless of race or ethnicity, whereas experiences of weight stigma and bias differ across White, Black, and Hispanic groups with obesity, new research found.
    • “Clinicians need to know their patients, understand them from a cultural and racial perspective, and tailor treatment plans to align with their expectations and needs. This will improve motivation, engagement, and adherence,” study author Rodolfo J. Galindo, MD, Director of the Comprehensive Diabetes Center, Lennar Medical Center, University of Miami Health System, told Medscape Medical News.
    • “Obesity medicine physician scientist Fatima Cody Stanford, MD, Massachusetts General Hospital and Harvard Medical School, Boston, told Medscape Medical News that the new findings add “an important, clinically relevant nuance that weight stigma is not monolithic and that experiences and attitudes can differ meaningfully across racial/ethnic groups among adults living with obesity.”
  • The American Medical Association lets us know what doctors wish patients knew about social isolation.
  • Medscape informs us,
    • “Can agnostic therapies revolutionize precision oncology? Are we ready to treat cancer without looking at the organ? For decades, cancer has been told as a story of organs: lungs, breast, colon, etc. Each diagnosis implied a predictable therapeutic path. In recent years that map has begun to blur, and in oncology clinics it is increasingly common for specialists to focus less on the patient’s cancer type and more on the molecular alteration driving its growth. The idea is to concentrate on the molecular footprint rather than the organ — a shift that is transforming precision oncology.”
  • and
    • “Described for the first time in the 1940s, lipedema has long been misunderstood, often mistaken for common obesity or lymphedema and frequently treated as a cosmetic issue. This has produced chronic underdiagnosis, stigma, and fragmented care.
    • “But that picture has changed structurally with the recent publication of the Lipedema World Alliance’s first international consensus on the definition and management of lipedema, based on the Delphi method.
    • “Specialists from 19 countries contributed 59 consensus statements covering definition, pathophysiology, diagnosis, impact on quality of life, therapeutic strategies, and future research directions. Rather than offering definitive solutions, the document provides a shared starting point for clinicians, researchers, and policymakers.”
  • Fierce Pharma points out,
    • “The treatment landscape for clear cell renal cell carcinoma (ccRCC) could be due for a shake-up following dual breakthroughs from Merck’s Litespark clinical trial program for Welireg. Data being presented at the 2026 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium suggest that adding Welireg to other existing drugs significantly improves outcomes for patients at two distinct stages of their cancer journeys.
    • “For advanced ccRCC patients whose cancer has recurred following previous immunotherapy, a combination of Welireg (belzutifan) and Merck’s Eisai-partnered Lenvima (lenvatinib) significantly reduced patients’ risk of disease progression or death by 30% compared with Exelixis’ Cabometyx (cabozantinib), according to results from the Litespark-011 trial.
    • “Separately, in patients with resected ccRCC at an increased risk of recurrence following surgery, by adding Welireg to Merck’s standard Keytruda, investigators achieved a 28% reduction in the risk of the patients’ cancer returning, according to data from the Litespark-022 study.”

From the U.S. healthcare business front,

  • The Healthcare Cost Institute reports,
    • “Hospital outpatient care is a large and growing component of the health care spending equation among ESI [employer sponsored insurance] enrollees. There is a disconnect between the most common reasons for hospital outpatient visits and the drivers of spending. Diagnostic tests, imaging, and evaluation and management visits accounted for more than 75% of visits in 2022, but these three categories represented just 39% of spending, which was largely driven by imaging procedures. Meanwhile, major surgeries and minor procedures accounted for 34% of spending despite being only 8% of visits.
    • “Site neutral payment policies are one approach to curbing the growth of hospital outpatient spending. These policies require providers to charge the same amount for a service regardless of whether it was performed in a hospital outpatient department or a less intensive setting like a doctor’s office. Site neutral payments could reduce the amount of money spent on imaging and evaluation and management visits, but may not be appropriate for major surgeries like joint replacement.
    • “Hospital outpatient services are also nearly three times more expensive in ESI than in Medicare. Policies that aim to align Medicare and ESI payments for outpatient care may be more suited to addressing the drivers of cost like outpatient surgery and other higher intensity procedures. Payment parity policies can also impact lower-cost, high-volume services like mammography and diagnostic testing. Effective approaches to addressing outpatient hospital costs will require creativity and a blended approach that accounts for the wide spectrum of care delivered in this setting.”
  • Healthcare Dive relates,
    • “For-profit hospital operator Universal Health Services expects to increase admissions and hit long-standing growth targets in its behavioral health unit this year, executives said on a fourth-quarter earnings call Thursday.
    • “Executives said 2026 would be the year its behavioral health unit achieved 2% to 3% growth in adjusted patient days — a number the system has struggled to hit as it tries to address lagging growth at its behavioral facilities. The system initially expected to hit that target last year, but deferred due to challenges with labor and staffing.
    • “Still, executives said they anticipate multiple headwinds this year, including losses from the lapse of more generous subsidies in Affordable Care Act plans and a new staffing law in California.”
  • BioPharma Dive tells us,
    • “UniQure lost nearly half a billion dollars in market value Thursday, as comments made by the head of the Food and Drug Administration appeared to stoke investor fears that the company’s most advanced research project won’t be approved in the U.S.
    • “Shares of UniQure dropped more than 30% shortly after FDA Commissioner Martin Makary appeared on CNBC to defend the agency’s approach to approving rare disease therapies. The agency has come under fire for multiple delays and regulatory setbacks involving these medications. Makary, though, said critics have been searching for a “boogeyman” to blame for recent rejections, when the bottom line is that some of these therapies just haven’t been proven effective.
    • “He mentioned, as one example, how the FDA was pressured to approve a product that’s injected into the space surrounding the brain, through a burr hole drilled into patients’ skulls.
    • “Makary didn’t name any company, but that didn’t stop some investors from interpreting his remarks as a reference to UniQure’s “AMT-130,” a gene therapy for Huntington’s disease administered via burr hole.
    • “Wall Street analysts noted that Makary might not have been talking about UniQure * * *.
    • In any case, what’s notable from Makary’s appearance is his “steadfast defense” of the FDA, “which is discouraging for those hoping that the agency can be convinced to reconsider recent negative decisions, in the absence of specific political pressure,” wrote Paul Matteis, of Stifel, in a note to clients.
  • MedTech Dive informs us,
    • GE HealthCare has struck a 10-year deal with UCSF Health to support imaging at the healthcare system, the company said Thursday.
    • UCSF Health will work with GE HealthCare to implement remote scanning capabilities, train staff and improve magnetic resonance imaging performance. 
    • The agreement is part of a series of large deals involving GE HealthCare. CEO Peter Arduini told investors last month that the company has inked enterprise deals worth $7 billion in three years.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive reports,
    • “The Trump administration late Thursday removed the scandal-plagued acting director of the Cybersecurity and Infrastructure Security Agency, injecting fresh uncertainty into the operations of an agency already grappling with a morale crisis as it tries to protect the U.S. from sophisticated hacking threats.
    • “The Department of Homeland Security reassigned Madhu Gottumukkala, the deputy CISA director who had led the agency in an acting capacity since last May, to a position at DHS headquarters. Nick Andersen, the executive assistant director for CISA’s Cybersecurity Division and one of the few remaining political appointees at the agency, will step in as acting director.”
  • Federal News Network adds,
    • “Sen. Ron Wyden (D-Ore.) is blocking the Trump administration’s nominee to lead both U.S. Cyber Command and the National Security Agency. Wyden said Lt. Gen. Joshua Rudd, who currently serves as the deputy commander of U.S. Indo-Pacific Command, lacks the experience needed to immediately step into the dual leadership role. The lawmaker added that when it comes to U.S. cybersecurity, “there is simply no time for on-the-job learning, the threat is just too urgent for that.”
  • Gov Info Security relates,
    • “A bipartisan group of senators called on the federal government to update the regulations governing healthcare cybersecurity through a Thursday vote sending a bill aimed at bolstering sector resilience to the full Senate.
    • ‘The Senate Health, Education, Labor and Pensions Committee voted 22 to 1 to advance the Health Care Cybersecurity and Resiliency Act, a bill that requires publishing cybersecurity guidance for rural medical practices and improved coordination between federal agencies.
    • It has the backing of a healthcare cybersecurity working group that includes committee Chair Bill Cassidy, R-La.
    • “The legislation would additionally bolster an apparently stalled effort to update the HIPAA Security Rule that the Department of Health and Human Services published during the final weeks of the Biden administration (see: What’s in HHS’ Proposed HIPAA Security Rule Overhaul?).
    • “The bill would enforce many of the proposed rule’s updates, including requiring HIPAA-covered organizations and business associates to adopt multifactor authentication and encryption, to conduct audits, including penetration testing. It additionally calls for “other minimum cybersecurity standards” to be determined by the HHS secretary, “in consultation with private sector organizations, based on landscape analysis of emerging and existing cybersecurity vulnerabilities and consensus-based best practices.”
    • “The fate of the Biden administration’s proposed HIPAA overhaul is uncertain at this point. The HHS Office of Civil Rights is expected to make some kind of decision in May on whether it will move forward with the proposals, or perhaps issue a revised version of proposed rulemaking.”
  • Cyberscoop notes,
    • “An ex-L3 Harris executive was sentenced to over seven years in prison Tuesday after pleading guilty to selling eight zero-day exploits to a Russian broker in exchange for millions of dollars.
    • “Peter Williams, 39, admitted to two counts of theft of trade secrets in U.S. District Court in Washington, D.C., last year, acknowledging he took at least eight exploits or exploit components while working at Trenchant, a specialized cybersecurity unit owned by L3Harris. Prosecutors said the materials were intended for restricted use by the U.S. government and allied partners.
    • “Authorities said Williams sold the stolen information to a broker that advertised itself as a reseller of hacking tools and described it as serving multiple customers, including the Russian government. In court, the government referred to the buyer as “Company 3,” but details read aloud during the plea hearing pointed to Operation Zero, a Russian exploit broker that publicly markets itself online as a platform for purchasing zero-day vulnerabilities.”

From the cybersecurity breaches and vulnerabilities front,

  • Cybersecurity Dive reports,
    • “Federal agencies have until Friday evening [February 27] to update certain Cisco networking devices that are vulnerable to compromise, the Cybersecurity and Infrastructure Security Agency said on Tuesday [February 24].
    • “In an emergency directive about Cisco’s Software-Defined Wide-Area Networking (SD-WAN) systems, CISA said it was “aware of a cyber threat actor’s ongoing exploitation” of two vulnerabilities in Cisco Catalyst SD-WAN Manager and Catalyst SD-WAN Controller devices and called the activity “an imminent threat to federal networks.”
  • and
    • “The Cybersecurity and Infrastructure Security Agency on Thursday warned that a malware variant previously used in attacks against Ivanti Connect Secure environments may remain undetected on systems. 
    • “In March 2025, CISA issued an alert about the malware, dubbed Resurge, in connection with exploitation of CVE-2025-0282, a stack-based buffer overflow vulnerability in certain versions of Ivanti Connect Secure and other Ivanti products. 
    • “The agency has since analyzed three samples from a critical infrastructure provider’s Ivanti Connect Secure device after hackers exploited the flaw to gain initial access. The analysis shows that Resurge can remain latent on a device until a remote hacker attempts to contact the device.” 
  • Cyberscoop adds,
    • “Would-be attackers spent 2025 swimming in a sea of more than 40,000 newly published vulnerabilities, VulnCheck said in a report released Wednesday, but only 1% of those defects, just 422, were exploited in the wild.
    • “As the deluge of vulnerabilities grows every year, and CVSS ratings lose significance for vulnerability management prioritization, some defenders are turning to research on known exploited vulnerabilities to narrow their scope of work and place more emphasis on verified risks. 
    • “The growth in CVE volume is ludicrous, not necessarily unfounded, but it’s large. Defenders don’t know what to pay attention to,” Caitlin Condon, vice president of security research at VulnCheck, told CyberScoop. “Prioritization is still a huge problem.”
    • “Too many defenders and researchers are paying attention to defects and unsubstantiated exploit concepts that aren’t worth their time, Condon added. “The indicators of risk that used to be semi reliable, now no longer are.”
  • and
    • “Cyberattacks reached victims faster and came from a wider range of threat groups than ever last year, CrowdStrike said in its annual global threat report released Tuesday, adding that cybercriminals and nation-states increasingly relied on predictable tactics to evade detection by exploiting trusted systems.
    • “The average breakout time — how long it took financially-motivated attackers to move from initial intrusion to other network systems — dropped to 29 minutes in 2025, a 65% increase in speed from the year prior. “The fastest breakout time a year ago was 51 seconds. This year it’s 27 seconds,” Adam Meyers, head of counter adversary operations at CrowdStrike, told CyberScoop.
    • “Defenders are falling behind because attackers are refining their techniques, using social engineering to access high-privilege systems faster and move through victims’ cloud infrastructure undetected.”
  • Cybersecurity Dive points out,
    • “Hackers are increasingly integrating artificial intelligence into all phases of the cyberattack life cycle, with the technology regularly analyzing target information, generating phishing emails and providing coding assistance, security firm ReliaQuest said in a report published on Tuesday [February 24].
    • “Other recent reports from IBM and cyber insurer Resilience similarly highlight how AI has changed the threat landscape.
    • At the same time, a new Sophos report said it was important to put in perspective AI’s ‘capabilities and impact.”
  • LinkedIn informs us,
    • “One of the largest data breaches in U.S. history is even bigger than was known. The Conduent cyberattack has now affected more than 25 million Americans, according to a recent update. The January 2025 incident exposed Social Security numbers, medical records and other sensitive information. Conduent is one of the largest contractors for the U.S. government, providing mailroom, printing and payment processing services for state government benefit offices — meaning it manages “a large amount of personal information belonging to a large swath of the United States,” per TechCrunch.”
  • Cybersecurity Dive adds,
    • “Hackers working for the Chinese government broke into more than 50 telecommunications companies and government agencies in 42 countries, in a campaign that exploited cloud platforms’ legitimate features to hide the attackers’ tracks.
    • “The attacker was using API calls to communicate with [software-as-a-service] apps as command-and-control (C2) infrastructure to disguise their malicious traffic as benign,” researchers at Google’s Threat Intelligence Group and Mandiant said in a report on Wednesday.
    • “Google said the “prolific, elusive” China-linked hacker team, which it tracks as UNC2814, “has a long history of targeting international governments and global telecommunications organizations across Africa, Asia, and the Americas.”

From the ransomware front,

  • The Mississippi Clarion Ledger reports,
    • “Officials with the University of Mississippi Medical Center stated the hospital system is “getting closer to full functions” following a cyberattack on Feb. 19 that disrupted operations.
    • “UMMC issued a statement Friday, Feb. 27, stating after being able to access patient records, clinics statewide will resume normal operations and scheduled appointments on Monday, March 2.
    • “UMMC also stated that on March 2, clinics will begin reaching out to patients to reschedule appointments that were cancelled. Officials added that UMMC clinics will reopen with extended hours and additional days in order to accommodate patients as soon as possible.
    • “All hospitals and emergency departments located in Jackson, Madison County, Holmes County and Grenada remain open.”
  • Cybersecurity Dive relates,
    • “UFP Technologies, a Massachusetts-based medical device maker, said it is investigating a cyberattack in mid-February that led to some of its company data being stolen or potentially destroyed, according to a regulatory filing. 
    • “The company said the attack, which was detected Feb. 14, impacted most of its IT network, as well as its billing and label-making capabilities for customer deliveries. The company said it was able to continue operations using data backups and implementing contingency plans.
    • “This was a classic ransomware attack that appeared to have impacted many, but not all, of our IT systems,” Ronald Lataille, chief financial officer at UFP Technologies, said Wednesday on a quarterly conference call with analysts. “Data was taken and then destroyed.”
    • “The company is still trying to figure out how much sensitive information, including personally identifiable data, may have been impacted by the attack, according to the 8-K filing with the Securities and Exchange Commission. However, the company does not currently believe the attack will have a material impact on its financial condition.”
  • The Hacker News adds,
    • “The North Korea-linked Lazarus Group (aka Diamond Sleet and Pompilus) has been observed using Medusa ransomware in an attack targeting an unnamed entity in the Middle East, according to a new report by the Symantec and Carbon Black Threat Hunter Team.
    • “Broadcom’s threat intelligence division said it also identified the same threat actors mounting an unsuccessful attack against a healthcare organization in the U.S. Medusa is a ransomware-as-a-service (RaaS) operation launched by a cybercrime group known as Spearwing in 2023. The group has claimed more than 366 attacks to date.
    • “Analysis of the Medusa leak site reveals attacks against four healthcare and non-profit organizations in the U.S. since the beginning of November 2025,” the company said in a report shared with The Hacker News.”
  • The Register informs us,
    • “Ransomware payments cratered in 2025, but it seems like the cybercrooks launching the attacks didn’t get the memo.
    • “That’s the headline from Chainalysis’ 2026 Crypto Crime Report, which shows total on-chain ransomware payments falling for a second straight year, even as victim counts and leak site pressure continue to climb.
    • “Ransomware gangs pulled in about $820 million in 2025, roughly 8 percent less than the year before, as the share of victims paying dropped to an all-time low of 28 percent. That drop might sound like progress if the wider picture weren’t so bleak: the median ransom demand jumped from $12,738 in 2024 to $59,556 in 2025, and the number of publicly claimed attacks climbed along with it.
    • “Despite the relative stability in total payments, ransomware attacks surged across multiple vectors in 2025, with eCrime.ch data showing a 50 percent YoY increase in claimed ransomware victims, marking the most active year on record,” Chainalysis said.”
  • Help Net Security adds,
    • Intrusions continue to center on credential access and timed execution outside standard business hours. The Sophos Active Adversary Report 2026 analyzes 661 incident response and managed detection and response cases handled between November 1, 2024 and October 31, 2025, spanning organizations in 70 countries.
    • “The dataset examines how attackers gain access, how quickly they reach key systems, and when ransomware and data theft occur.” * * *
    • “Timing patterns show that the most disruptive stages of ransomware incidents often occur when organizations are operating with reduced staffing. In 88% of ransomware cases, encryption was deployed during non business hours.
    • “Data exfiltration followed a similar pattern, with 79% of theft activity also occurring outside the typical workday.
    • “Off hours deployment increases the likelihood that encryption or large scale data transfers proceed without immediate interruption. It places emphasis on monitoring coverage that extends beyond standard schedules.”

From the cybersecurity business and defenses front,

  • Dark Reading reports,
    • “The cybersecurity venture capital market experienced unprecedented activity in 2025, driven primarily by the rush to AI-native security solutions and a massive surge in mergers and acquisitions that reached record levels.
    • “In 2025, VC firms invested $119 billion in cybersecurity businesses, with 400 M&A transactions accounting for the majority of funding and another 820 financing deals totaling nearly $21 billion, according to data from Momentum Cyber, a cybersecurity investment bank. The total value of M&A, financing, and IPO activity in 2025 nearly tripled that of deals in the previous year.”
  • and
    • “Cybersecurity experts are calling for a major shift in how companies handle data breaches and security failures, arguing that greater transparency and specific detail disclosure about how and why they occur is essential if the industry hopes to effectively reduce cyber-risk.
    • “At the upcoming RSAC Conference, threat research experts Adam Shostack and Adrian Sanabria will make the case for greater incident transparency and the need for structured feedback loops in cybersecurity, in a session aptly titled “A Failure Is a Terrible Thing to Waste: The Case for Breach Transparency,”scheduled for Monday, March 23.”
  • Cybersecurity Dive informs us,
    • “The AI era is transforming what CISOs do and how they do it, the enterprise software firm Splunk said in a report published on Tuesday [Feburary 24].
    • “Nearly all CISOs have been assigned to manage their organizations’ AI governance responsibilities, the report found, a significant expansion of “their already overwhelming mandates.”
    • CISOs interviewed in the report expressed both an awareness that they needed to use AI and a range of concerns about its potential harms.”
  • Dark Reading relates,
    • “As one ransomware community shutters in RAMP, two more pop up to take its place. 
    • “Rapid7 today published an analysis of that ransomware ecosystem after US authorities seized infrastructure tied to the notorious RAMP cybercrime forum last month. For years, RAMP has been the primary vehicle for acquiring ransomware-as-a-service (RaaS) affiliates, but the Jan. 28 interagency sting led by the FBI forced many cybercrime outfits to find a new means to sell their wares. 
    • “Rapid7’s Alexandra Blia and Efi Sherman in this week’s blog post identified two potential forums where attackers might go next. The bigger takeaway, however, is that the cybercrime ecosystem is fragmenting, and defenders will need to adapt.”
  • and
    • A newly developed method for gauging the impact of an OT cybersecurity incident could pave the way for more accurate measurement and response to an event, and also shine light on risk and business ramifications.
    • The Operational Technology Incident (OTI) Impact Score — which will be unveiled today [February 24] at the ICS/OT industry’s S4x26 Conference in Miami — aims to provide rapid clarity on the actual effects of OT cyber incidents, which often get over- or under-hyped, according to Dale Peterson, co-creator of the OTI model and head of ICS/OT consulting and research firm Digital Bond.
    • The OTI model, inspired by the Richter Scale used for measuring earthquake intensity and impact, is meant for OT business executives, governments, cyber insurers, the media, and the general public, according to Peterson, who is the founder and program chair of S4.
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, Telehealth, U.S. Healthcare–

From Washington, DC

  • Fierce Healthcare reports,
    • “The Trump administration has proposed flat rates in Medicare Advantage (MA) for 2027, and insurers argue in new commentary that those levels do not reflect the realities of the program.
    • “In late January, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed advance notice governing MA and Part D. 
    • “The proposal includes a net payment rate increase of 0.09% in MA, meaning levels will be essentially flat if the plan becomes final.
    • “The proposed rule drew immediate ire from the industry, which is already navigating significant financial challenges in this market. Multiple leading players have elected to exit certain MA markets. 
    • “In official comments (PDF) submitted Wednesday to the CMS, the AHIP said the proposed rule “risks undermining CMS’ goal of providing beneficiaries with stable, affordable choices during the annual enrollment period.”
    • “At a time of sharply rising medical costs and high utilization of medical services, the combined effect of the proposed policy changes and growth rates will not keep pace with the cost of caring for seniors in 2027,” the organization, which is the largest lobbying group representing insurers, said in its comment letter.”
  • MedPage Today relates,
    • A top health official at the Centers for Medicare & Medicaid Services (CMS) [Chris Klomp] hedged on payment reform, but committed to helping physicians address prior authorization challenges, during the American Medical Association’s (AMA) National Advocacy Conference.”
  • Per Beckers Health IT,
    • “CMS has rolled out an app directory for Medicare recipients as part of the agency’s push to digitize healthcare.
    • “The Medicare App Library seeks solutions that fall under one of three use cases: “kill the clipboard,” conversational AI assistants, or diabetes and obesity prevention and management.
    • “We are calling on health app developers, tech-enabled organizations, and innovators to voluntarily align around a shared framework for data and access that empowers people, improves care, and accelerates progress,” CMS stated Feb. 23. “This is a movement, not a mandate. It is a call to action, not a regulation. Let’s show what’s possible when we work together — and finally bring healthcare into the modern era.”
  • Federal News Network tells us
    • “Tens of thousands of federal employees at U.S. Customs and Border Protection are expected to continue receiving pay during the Department of Homeland Security’s current funding lapse, according to an email viewed by Federal News Network.
    • “CBP, a component of DHS, plans to use discretionary funding from the One Big Beautiful Bill Act to exempt and continue paying more than 57,600 agency employees who have been working throughout the partial shutdown this month. Details of the agency’s decision come from an email sent this week by the National Treasury Employees Union, obtained by Federal News Network.
    • “Under the current shutdown, CBP will “exempt” and provide pay to a large portion of its workforce, including law enforcement personnel and certain civilian agency employees. Some other CBP employees, however, are still considered “excepted” and will not receive pay until after the shutdown ends.”
  • MedTech Dive informs us,
    • “The Trump administration is imposing a six-month moratorium on Medicare enrollment for certain suppliers of durable medical equipment, prosthetics and orthotics, or DMEPOS, as part of a broader plan to combat fraud in healthcare.
    • “The administration said Wednesday that the nationwide halt on enrollment would give the government time to consider more actions “to further mitigate longstanding instances of fraud, waste, and abuse perpetrated by certain DMEPOS companies.”
    • “The temporary freeze applies to all applications for initial enrollment and changes in majority ownership for medical supply companies.
    • “Durable medical equipment includes items such as walkers, wheelchairs, oxygen equipment, hospital beds, continuous positive airway pressure machines and blood sugar monitors.”
  • NCQA, writing in LinkedIn, announced its “Advanced Primary Care Pilot Program” and invited readers to “Meet Our Primary Care Partners!”
  • The Labor Department’s Employee Benefits Security Administration let us know about extending the public comment period on its proposed Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure rule to April 15, 2026.

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “The Food and Drug Administration on Tuesday posted a warning letter sent to Beta Bionics in late January.
    • “The letter raised concerns with how the diabetes tech company handled complaints of severe low and high blood sugar associated with its automated insulin delivery system. The FDA also flagged problems with the company making modifications to its device without notifying regulators.
    • “In an annual report filed Tuesday, the company said it has already taken several corrective actions, including improvements to the processes identified in the warning letter. The company is also preparing a written response to the letter.”
  • Cadiovascular Business informs us,
    • “Cara Medical, a medtech company focused on advanced imaging technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its new platform that noninvasively visualizes a patient’s cardiac conduction system.
    • “The CARA System, which previously earned the FDA’s breakthrough device designation, was designed to help interventional cardiologists and electrophysiologists plan ahead before procedures and then guide them during treatment. It can be used for structural heart interventions such as transcatheter aortic valve replacement (TAVR) as well as pacing procedures.
    • “The newly cleared system includes two primary components. The CARA Metis Simulator is a preprocedural planning software that identifies the cardiac conduction axis on CT angiography results and generates a 3D map of the patient’s conduction system. The CARA Atlas Navigator, meanwhile, overlays that map onto live fluoroscopic images to assist with intraprocedural guidance. 
    • “Artificial intelligence (AI) algorithms play a role in both components, extracting metadata and detecting the user’s catheter for visualization, but all AI calculations can still be confirmed by a physician.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated and increasing in some areas of the country. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits and hospitalizations among infants and children 4 years and younger.
    • Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The US Centers for Disease Control and Prevention (CDC) has ended its investigation into the recent multistate infant botulism outbreak traced to ByHeart powdered formula and lowered the total case number by three. In a Public Health Alert issued earlier this week, California, CDC, and Food and Drug Administration scientists reported 51 infections, but yesterday the CDC said it has excluded three suspected cases, for a total of 48 (28 confirmed, 20 probable) in November and December 2025. While the outbreak is over, investigators continue to probe how Clostridium botulinum bacteria got into the formula, the CDC said.
    • “A report published yesterday in the CDC’s Morbidity and Mortality Weekly Report describes how officials used artificial intelligence (AI) to identify contaminated ice in a beer cooler as the source of a 2024 Salmonella enterica outbreak at a county fair. Ice is an uncommon vehicle for Salmonella spread at public events, noted author Katherine Houser, RN, of the Brown County Health Department in Mount Sterling, Illinois. The outbreak sickened 13 people (seven confirmed, six probable cases). AI tools helped synthesize background information to support and contextualize the environmental health team’s assessment, Houser said.”
  • The CDC also announced today,
    • “As of February 26, 2026, 1,136 confirmed* measles cases were reported in the United States in 2026. Among these, 1,130 measles cases were reported by 28 jurisdictions: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Minnesota, Nebraska, New Mexico, New York City, New York State, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin. A total of 6 measles cases were reported among international visitors to the United States. 
    • “There have been 10 new outbreaks** reported in 2026, and 90% of confirmed cases (1,023 of 1,136) are outbreak-associated (152 from outbreaks starting in 2026 and 871 from outbreaks that started in 2025).”
  • MedPage Today informs us,
    • “Identical stool samples sent to seven direct-to-consumer microbiome testing companies produced substantially different bacterial profiles and health assessments.
    • “Across 18 commonly reported microbial genera, no company’s results matched the consensus; and only three genera of 1,208 identified taxa appeared in every report.
    • “Researchers attributed the discrepancies to differences in laboratory methods and analysis pipelines, and say the results underscore the need for standardized testing and quality controls.”
  • The Wall Street Journal considers
    • “Why All The Fuss About Bone Density?
    • “Like most of my peers, I’m being bombarded daily with hectoring advice about my bones. What’s a 40-something woman to do?” * * *
    • “For guidance, [the journalist] consult[s] with Dr. Karen Tang, the author of “It’s Not Hysteria: Everything You Need to Know About Your Reproductive Health (but Were Never Told),” who offers a more measured take.” 
  • Medscape adds,
    • “A low-dose, single pill that combines three antihypertensive treatments is as effective as standard-dose monotherapy — in some cases even better — for treating mild-to-moderate hypertension, according to the first phase 3 double-blind trials comparing the medications.
    • “Investigators for the HM-APOLLO-301 and HM-APOLLO-302 phase 3 clinical trials, which were published in the Journal of the American College of Cardiology, contend there is now concrete evidence to support the efficacy of the single-pill therapy.
    • “They argue that starting with the traditional single-agent therapy and then titrating up can delay blood pressure control, increase the possibility of adverse effects, and affect patient adherence.”
  • The University of Minnesota’s CIDRAP relates,
    • “The results of a randomized controlled trial (RCT) indicate that meningococcal B vaccine is not effective at preventing gonorrhea infection in high-risk groups.
    • “The results, presented this week at the Conference on Retroviruses and Infections by a team of Australian researchers, show that among gay and bisexual men with a history of gonorrhea infection who received either the 4CMenB vaccine or placebo, gonorrhea incidence was essentially the same—roughly 48% in both arms.
    • “The 4CMenB vaccine is designed to protect against four serogroups of Neisseria meningitidis, which can cause invasive meningococcal disease. But in recent years, observational studies have suggested 4CMenB might also provide moderate cross-protection against Neisseria gonorrhoeae, the bacterium that causes gonorrhea—one of the most common sexually transmitted infections (STIs) worldwide.” 
  • Genetic Engineering and Biotechnology News reports,
    • “CAR T cell therapy has revolutionized the treatment of many blood cancers, but has shown little success against solid tumors, which account for more than 85% of all cancers.
    • “Columbia University researchers have now developed a new form of highly sensitive CAR T cells, known as HIT T cells, that aims to overcome one of the biggest barriers in solid tumor immunotherapies, which is the way that solid tumors lack a single, widely shared surface target.
    • “Headed by Michel Sadelain, MD, PhD, director Columbia Initiative in Cell Engineering and Therapy (CICET), the researchers engineered an ultra-sensitive and highly selective chimeric antigen receptor called an HLA-independent T cell (HIT) receptor, which is capable of detecting even the smallest amounts of the protein CD70 on tumor cells.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance is consolidating control of its health insurance businesses under Felicia Norwood, its head of government benefits, as the company looks to improve coordination across its Medicaid, Medicare and commercial plans and — hopefully — bolster waning profits.
    • “Mark Kaye, Elevance’s CFO, will also take on leadership of health services division Carelon as current president Peter Haytaian leaves to spend more time with his family, according to a press release Thursday announcing the executive changes.
    • “Haytaian will leave the role effective May 4 and stay on as an advisor through the end of the year. The executive first joined Elevance in 2012 through its acquisition of Amerigroup before becoming president of Carelon in 2021.”
  • Beckers Payer Issues adds,
    • “Longtime UnitedHealth Group executive Heather Cianfrocco is leaving the company.
    • Ms. Cianfrocco has served as executive vice president of governance, compliance and information security at UnitedHealth since April 2025. She briefly served as CEO of Optum from 2024 to 2025 before being succeeded by Patrick Conway, MD, who previously led Optum Rx. 
    • “After 24 years, I am saying goodbye to the team at UnitedHealth Group,” she wrote on LinkedIn Feb. 27. “I am leaving with so much pride in what we have accomplished together. I’ve had the privilege of working alongside some of the most talented, mission-driven people who show up every day determined to make health care easier to navigate, more affordable and more human.”
  • Beckers Hospital Review notes,
    • “CVS Caremark is expanding its use of Surescripts’ Touchless Prior Authorization platform to accelerate approvals for select specialty medications.
    • “The prior authorization technology connects directly to patients’ EHRs to gather required clinical data and match it with prior authorization criteria, according to a Feb. 25 news release. When requirements are met, CVS Caremark can approve medications automatically in as little as 22 seconds.
    • “The platform is currently used for select specialty drugs, including Vivitrol and Epidiolex, which treat substance use disorder and epilepsy. These medications typically require complex approvals because of their high impact and specialized clinical use cases.”
  • Healthcare Dive tells us,
    • “Teladoc Health projects membership in its business-to-business integrated care unit will decline this year, in part due to the expiration of enhanced Affordable Care Act subsidies, management said during a fourth-quarter earnings call Wednesday.
    • “The company expects 97 million to 100 million members in U.S. integrated care in 2026, down from 101.8 million at the end of last year. 
    • ‘Teladoc expects the decline will be driven by enrollment reductions at some client health plans in government programs, which were impacted by the lapse of more generous financial assistance for ACA coverage, CEO Chuck Divita said on the call.”
  • Fierce Healthcare adds,
    • “Walgreens is wading into the self-pay GLP-1 space, going head-to-head with telehealth subscription offerings.
    • “The retail pharmacy giant launched a digital weight management service to offer access to personalized, clinician-guided support for weight loss. The service expands Walgreens’ virtual healthcare platform and provides patients with access to licensed doctors and nurse practitioners, FDA-approved medication options and ongoing virtual support, according to the company in a press release.
    • “Virtual visits through the weight management service cost $49 with no requirement for a monthly subscription. The program, currently available in 28 states, is intended for eligible overweight and obese adults ages 18-64 who plan to self-pay for their GLP-1 medication.”
  • Healthexec summarizes news from “the 2026 ViVE conference, part of HLTH, [which] just wrapped up in California. On the show floor, people from across the healthcare and health IT space gathered for four days of events, thought leader insights and product showcases on the floors of the Los Angeles Convention Center. 

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.”

Midweek report

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

From Washington, DC,

  • Healthcare Dive reports,
    • “America has entered its “golden age,” President Donald Trump argued in a lengthy State of the Union address Tuesday night that glossed over the biggest achievements of the president’s second term so far but was notably light on healthcare.
    • “The economy is improving, prices are coming down, illegal immigration is under control and crime is plummeting, the president said, while lauding guests in attendance like Erika Kirk and the Olympic gold medal-winning U.S. men’s hockey team. Trump’s remarks — the longest State of the Union speech in recorded history, at an hour and 47 minutes — were often met with chants of “U.S.A! U.S.A!” from Republicans in the gallery, and come as the president seeks to reverse plummeting approval ratings.
    • “However, Trump didn’t use the State of the Union to introduce many new policy ideas. He also didn’t devote much time to healthcare, spending only about five minutes of his speech on the sector.”
  • Per an HHS news release,
    • “Today at the White House, Vice President J.D. Vance, Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr., and Administrator of the Centers for Medicare & Medicaid Services (CMS) Dr. Mehmet Oz announced new steps to crack down on fraud in Medicare and Medicaid to protect patients and taxpayers and improve affordability. The actions include deferring $259.5 million of quarterly federal Medicaid funding in Minnesota to prevent payment of questionable claims while further investigation is completed; a nationwide moratorium on Medicare enrollment for certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers; and a nationwide call to action for Americans to support fraud prevention, including stakeholder input on how CMS can continue to expand and strengthen its efforts. Together, these steps reflect a coordinated, data-driven strategy to prevent fraud before it occurs, hold bad actors accountable, and protect taxpayer dollars.”
    • * * * “CMS is looking to stakeholders to provide input, based on their experience and knowledge, on additional ways the agency can tackle fraud prevention to help inform the development of a possible future rule under CMS’ Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative. The CRUSH request for information (RFI) seeks input from a broad range of stakeholders – including states, providers, suppliers, payers, technology companies, patient advocates, beneficiaries, and others – on ways to strengthen CMS’ ability to prevent, detect, and respond to fraud, waste, and abuse, and program inefficiencies in Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.” * * * 
    • “Comments on the CRUSH Request for Information must be submitted by March 20, 2026, via the Federal Register at: https://www.federalregister.gov/public-inspection/2026-03968/request-for-information-comprehensive-regulations-to-uncover-suspicious-healthcare (refer to CMS-6098-NC).
    • “More information on CMS’ fraud prevention efforts is available at: www.cms.gov/fraud.”
  • Govexec offers five things to watch concerning the Department of Homeland Security shutdown.
  • The Wall Street Journal relates,
    • “President Trump’s nominee for surgeon general aligned herself with the administration’s moves on vaccines so far, including shrinking the number of recommended vaccines for children, as she told lawmakers in her confirmation hearing that her focus is fighting chronic disease. 
    • “Dr. Casey Means told the Senate health committee on Wednesday that she believes vaccines save lives but declined to promise recommending measles and flu shots for children. 
    • “I’m not an individual’s doctor, and every individual needs to talk to their doctor before putting medication in their body,” Means said, in response to a question about whether she would recommend other mothers get measles vaccines for their children.” 
  • Per an OPM news release,
    • “The US Office of Personnel Management today issued a memorandum to federal agencies providing updated guidance ending use of the Administrative Careers with America (ACWA) assessment. This step reinforces the administration’s ongoing efforts to streamline hiring and ensure agencies recruit the most qualified applicants based on merit.
    • “From the beginning, ACWA (which was developed in response to the Luevano consent decree) was criticized by hiring managers and applicants alike as ineffective in identifying quality candidates for federal service. In light of OPM’s development of validated, state-of-the-art assessment tools (particularly the USA Hire platform), there is no longer a need for ACWA.”
    • * * * “Read the memo here and Director Kupor’s blog on this here.”
  • Govexec also explains why “Why your federal benefits may not protect your family the way you think.”
    • “While federal employee benefits can assist beneficiaries in the event of a loved one’s death, it’s important to understand the rules of those plans and how to best seamlessly apply them to your survivors.”
  • The American Hospital Association (AHA) News tells us,
    • “The Health Resources and Services Administration Feb. 25 said it will extend the deadline to April 20 to receive comments on its request for information on whether to implement a 340B rebate model program. Comments on the RFI were originally due March 19. The AHA, joined by several other national groups representing 340B hospitals, last week urged HRSA to extend the original deadline to allow stakeholders to provide feedback to HRSA’s detailed questions in the RFI.  
    • “HRSA also indicated that it may expand the 340B rebate model pilot program to all drugs included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program through 2027.”   
  • Per a Federal Register notice,
    • The Centers for Disease Control announced a meeting of its Advisory Committee on Immunization Practices.
    • “The meeting will be held on March 18, 2026, from 8 a.m. to 5 p.m., EST, and March 19, 2025, from 8 a.m. to 5 p.m., EST, (times subject to change; see the ACIP website for updates: https://www.cdc.gov/vaccines/acip/index.html). The meeting is expected to be held at the Centers for Disease Control and Prevention, with virtual option. Written comments must be received between March 2 – 12, 2026.”
  • Mercer lets us know,
    • “Mercer projects the 2027 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs), and excepted-benefit health reimbursement arrangements (HRAs) will increase from 2026 levels. These unofficial 2027 amounts are determined using the Internal Revenue Code (IRC)’s cost-of-living adjustment methods, the US Bureau of Labor Statistics (BLS) published Chained Consumer Price Index for All Urban Consumers (C-CPI-U) values through January 2026, and Mercer’s projected C-CPI-U values for February and March.
    • ‘The table [in the article] shows the projected HSA, HDHP, and excepted-benefit HRA amounts for 2027, along with the 2026 and 2025 values for comparison. The HSA catch-up contribution limit is set by statute and hasn’t changed since 2009.
  • The Government Accountability Office notes,
    • “Mental health, suicide, and substance misuse issues have increased in the U.S. The federal agency that oversees such issues saw its budget more than double in FY21 due to increased COVID-19 and 988 Lifeline funding. This Q&A examines the use of that funding.
    • “The agency received $8.5 billion for COVID-19. It awarded about $8.3 billion in grants for activities such as community mental health. Recipients spent about $6.9 billion as of July 2025.
    • “The agency got $1.6 billion in FY21-24 for the 988 Lifeline, a call, text, and chat hotline supporting those in crisis. It awarded $1.2 billion to funding recipients, who had spent about $906.3 million.”

From the Food and Drug Administration front,

  • MedPage Today informs us,
    • “Assorted flavors of cream cheese were recalled by Made Fresh Salads due to possible Listeriacontamination, according to an FDA notice.”
  • The FDA issued today an “Early Alert: Heart Pump Purge Cassette Issue from Abiomed.”

From the judicial front,

  • Healthcare Dive reports,
    • “Frustrated by a recent, dramatic overhaul of the U.S. childhood immunization schedule, 15 Democrat-led states have sued the Trump administration in a bid to undo those changes as well as what they alleged to be an “unlawful replacement” of a key vaccine panel. 
    • “The lawsuit, filed by 14 attorneys general and the governor of Pennsylvania [in the U.S. District Court for the Northern District of California], seeks to rescind the new schedule adopted by the Department of Health and Human Services and vacate the committee, known as ACIP, reformed last year by Secretary Robert F. Kennedy Jr. Kennedy, the Centers for Disease Control and Prevention and the agency’s acting director, Jay Bhattacharya, are named as defendants in the suit.” 

From the public health, medical and Rx research front,

  • The AHA News reports,
    • “An American Heart Association study published Feb. 25 found that 6 in 10 U.S. women are projected to develop a form of cardiovascular disease by 2050. The report found a growing prevalence of heart disease, heart failure, atrial fibrillation and stroke and projected increases of conditions leading to cardiovascular disease, such as high blood pressure, obesity and diabetes. Additionally, the study found that nearly 32% of girls age 2-19 may be obese by 2050.”
  • Cardiovascular Business adds,
    • “Metabolic and bariatric surgery (MBS) is associated with better long-term cardiovascular protection than glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with type 2 diabetes and obesity, according to a new meta-analysis. The findings were published in full in Obesity Surgery.”
  • Healio tells us,
    • “Cervical cancer incidence has declined close to 30% among women aged 20 to 31 years since the start of the millennium, but certain states have achieved significantly greater reductions.
    • “Washington, D.C., Rhode Island, Michigan and Hawaii all achieved decreases of more than 50%, but incidence in Vermont, West Virginia, Idaho, Arkansas and Alabama remained unchanged.
    • “Researchers observed an association between increased HPV vaccination rates and faster decline in incidence, as well.
    • “A decline of more than 50% observed in several states within such a relatively short period is rarely seen in cancer epidemiology, making these findings particularly striking,” Chenxi Jiang, MPH, associate scientist in surveillance, prevention and health services research at American Cancer Society, told Healio. “At the same time, they are highly encouraging, demonstrating what is achievable when prevention efforts are effectively implemented.”
  • Cigna Healthcare, writing in LinkedIn, points out
    • “Proactive mental health care helps lower overall medical costs.
    • “Untreated mental illness leads to higher health expenses and lost productivity.
    • “Investing in treatment for depression and anxiety yields a fourfold return.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies five forces reshaping pharmacy economics this year.
  • Fierce Healthcare reports,
    • “There’s been a flurry of recent activity in the direct-to-consumer space as drug costs and spending continue to rise.
    • “It’s with that backdrop that GoodRx announced Tuesday it would launch Employer Direct, a new program that allows employers to offer workers lower costs on branded products, which often carry the highest prices. Through the program, these firms can select branded drugs and subsidize the cost for the cash-pay price available through GoodRx.
    • “Employers in the program can also tap into GoodRx’s telemedicine solutions, which bring together the clinical care with the prescription fulfillment to ensure patients get the drugs they need.”
  • Modern Healthcare adds,
    • “Employers tired of dealing with health insurers now have another option at their disposal: Go through a different intermediary instead.
    • “Third-party vendors such as Lantern, Nomi Health and Transcarent are making a play for the employer market as businesses wage a perpetual struggle to manage rising health benefit costs. These platforms tout savings, flexibility and a seamless experience to enable direct contracting with providers at scale.
    • “Their reach, once limited, is now national and includes all types of medical services. Transcarent has more than 20 million members after it acquired care navigation company Accolade last year. Nomi Health serves 19 million members. Lantern’s specialty care platform has grown from 100,000 members to more than 12 million in the last decade.”
  • Fierce Healthcare notes,
    • “Uber Health is rolling out a new feature that allows patients who are comfortable with its platform to book their own rides.
    • “Uber’s healthcare platform has traditionally been a back-end option for providers and other partners to book rides to and from appointments on the behalf of the patient. Through this approach, Uber supported processes like transportation benefits and discharge planning for its partners.
    • “However, the company heard feedback from clients that the administrative time to do this was not insignificant, and that there were many patients who were familiar enough with Uber to book trips themselves, Cory Warner, global head of growth and operations for Uber Health, told Fierce Healthcare in an interview at ViVE on Tuesday.
    • “We’re really excited, because we’ve been able to advance the technology to meet the needs of some of our customers who’ve been sharing with us that, while we have a lot of folks that may not have a smartphone, we do have a number of patients and members who have the Uber app in their everyday life,” she said.”
  • Fierce Pharma informs us,
    • “Novartis is wasting little time sketching out the radiopharmaceutical details of its $23 billion U.S. investment push. Shortly after announcing a new manufacturing facility for the class of cancer meds in Florida, the pharma giant is revealing its intention to build another site in Texas. 
    • “The forthcoming 46,000-square-foot radioligand therapy (RLT) production plant will be set upin Denton, Texas—part of the greater Dallas-Fort Worth area—and becomes the fifth existing or planned radiopharmaceutical manufacturing site in Novartis’ U.S. network, the company said in a Feb. 25 release. 
    • “Construction is slated to kick off this year, with the site expected to come online in 2028, Novartis said. 
    • “The plant will generate jobs in fields like bioengineering, advanced manufacturing, quality and operations, although Novartis did not specify how many new hires it has planned.” 
  • Per BioPharma Dive,
    • “Novo Nordisk announced Wednesday a collaboration with startup Vivtex that’ll give it access to technologies that could yield new oral biologics for obesity and other metabolic diseases.
    • “The companies did not disclose the amount of guaranteed cash going from Novo to Vivtex in the deal. But the Boston biotechnology startup stands to gain as much as $2.1 billion, as well as sales royalties, if drugs emerging from the alliance progress and are eventually commercialized.”
  • and
    • “GSK is scooping up a promising experimental medicine for a dangerous type of high blood pressure through a $950 million acquisition of private Canadian drugmaker 35Pharma.
    • “The drug, HS235, has already completed Phase 1 testing in healthy volunteers and, according to GSK, should soon enter studies focused on either pulmonary arterial hypertension or a different pulmonary hypertension caused by a certain kind of heart failure. The company added that this medicine has potential to fight cardiovascular disease, deliver metabolic benefits and offer a lower risk of bleeding — a key limitation of current PH treatments.
    • “HS235 is a so-called activin signaling inhibitor, designed to fight the over-proliferation of cells that can thicken blood vessel walls. This drug class has already seen success; Merck & Co. won approval for one member, Winrevair, in 2024, and chalked up sales of more than $1.4 billion from it last year. Merck is looking to expand its usage as well.”
  • Per MedTech Dive,
    • “Quantum Surgical, which specializes in medical robotics for cancer treatment, said Tuesday that it has acquired NeuWave Medical from Johnson & Johnson.
    • “Quantum, based in Montpellier, France, with an office in Miami, said the deal supports its strategy of expanding robot-assisted tumor ablation treatment to reduce cancer mortality.
    • “Last year, J&J informed customers that it planned to discontinue the NeuWave business, before announcing in September that it had received a binding offer from Quantum to buy NeuWave.”

Tuesday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Monday report,

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

From Washington, DC,

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

From the Food and Drug Admininstration front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend Update

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

Happy Washington’s Birthday!

From Washington, DC,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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