Monday report

Mental health care

Monday report

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

From Washington, DC

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

From the judicial front,

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

From the public health, medical and Rx research front,

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

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

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

Tuesday report

David Ermer–CDC, Congress, Employee Wellness Programs, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Washington Post reports on the continuing shutdown of the Department of Homeland Security.
  • Federal News Network reports,
    • “Agencies are closing in on an opportunity to hire talent for temporary technology jobs, after the Office of Personnel Management released its first two shared certificates on Tuesday for the Trump administration’s “Tech Force” program.
    • “Lists of eligible candidates for software engineering and data engineering positions are now available for participating agencies to review and potentially hire, an OPM spokesperson confirmed to Federal News Network. If hired, selected employees would move into two-year roles to temporarily work on technology-related initiatives.
    • “Candidates who are listed on the new shared certificates have already passed three rounds of hiring evaluations, including a technical assessment, a resume review and a screening interview, said OPM Director Scott Kupor.”
    • “We hope to have several hundred people now who passed all three phases of that, where we will put them on a shared certificate, and then we will start to push that certificate out to all the participating agencies,” Kupor said during a March 5 event hosted by Federal News Network. “The agencies then have an opportunity, if they so choose, to do an additional round of interviews, if they want to make sure the person is the right fit for their organization.”
  • MedTech Dive tells us,
    • “The Advanced Research Projects Agency for Health, or ARPA-H, launched a new program on Tuesday to support development of biosensors that can track multiple signals such as inflammation markers, hormones or drug levels within the body.
    • ‘The program, called Delphi, will focus on using electronic “chiplets,” with the goal of being able to “mix and match” features across wearables and ingestible sensors.
    • “The initiative comes as Health and Human Services Secretary Robert F. Kennedy Jr. has emphasized a role for wearables in tracking health habits. Last year, the secretary said he wanted all Americans to use wearables, and the Food and Drug Administration’s device center launched a pilot that would allow the agency to waive premarket requirements for certain digital health devices while they collect real-world data under a Medicare program.”
  • Kevin Moss, writing in Federal News Network, points out special features of FEHB and PSHB plans.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “About five months after U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. touted leucovorin as “an exciting therapy that may benefit large numbers of children who suffer from autism” during a White House press conference, the FDA has approved the decades-old drug for a rare genetic condition with “autistic features” that represents a small subset of autism patients.
    • “The FDA has approved GSK’s brand-name leucovorin calcium tablets, Wellcovorin, to treat cerebral folate deficiency (CFD) but only in patients who have a confirmed variant in the folate receptor 1 (FOLR1) gene.”
  • and
    • “Issues at a former Catalent plant now owned by Novo Nordisk have derailed another FDA application, with Incyte announcing Friday that the FDA handed over a complete response letter for its PD-1 inhibitor Zynyz as a first-line treatment for non-small cell lung cancer (NSCLC).
    • “The rejection was not related to any efficacy or safety concerns but rather inspection findings at a fill-finish facility—specifically, the former Catalent plant in Bloomington, Indiana, which is now owned by Novo as part of Novo Holdings’ $16.5 billion acquisition of the CDMO in 2024.
    • “The setback comes more than a year after Incyte detailed a 25% reduction in the risk of death for a combination of Zynyz and chemotherapy versus chemo alone among patients with newly diagnosed metastatic NSCLC in the phase 3 Pod1um-304 trial.” * * *
    • “In a March 9 statement to Fierce Pharma, a Novo spokesperson said the company is “actively engaging with the agency to address its findings.”
  • Beckers Hospital Review informs us,
    • “Ipsen, a Paris-based drugmaker, is removing its cancer drug Tazverik (tazemetostat) from the U.S. market because of safety concerns. 
    • “An ongoing Tazverik clinical trial has reported adverse events of secondary hematologic malignancies — which are blood cancers — indicating “the risks may outweigh potential benefits for patients,” Ipsen said in a March 9 news release. 
    • “The FDA granted Tazverik accelerated approval in 2020. The drug is approved to treat epithelioid sarcoma, a rare, aggressive soft tissue cancer that affects a few hundred patients each year, and relapsed or refractory follicular lymphoma, a form of non-Hodgkin lymphoma.
    • “The company said it is voluntarily withdrawing Tazverik in all indications.”

From the judicial front,

  • Beckers Payer Issues reports,
    • “On March 8, a judge for the U.S. District Court in Connecticut approved a preliminary injunction against Aetna, ordering the insurer to alter its gender-affirming care policy for two plaintiffs.
    • “Several transgender women sued Aetna in 2024 over denied gender-affirming facial reconstructions. The complaint pointed to Aetna’s Clinical Policy Bulletin 0615, which outlines parameters for gender-affirming care.” * * *
    • “Under the preliminary injunction, Aetna must individualize coverage for Jamie Homnick, PhD, and Gennifer Herley, PhD, two of the plaintiffs. Both women lack access to this coverage and have been facing depressive symptoms due to gender dysphoria, a court document said.
    • “Aetna has a strong track record as a proud ally of the LGBTQ+ community and is committed to meeting the healthcare needs of all our members. As a third-party administrator for self-funded plan sponsors, our role is to administer benefits in accordance with the specific terms set forth by each plan,” Aetna said in a statement shared March 10 with Becker’s. 
    • “Many employer benefit plans may include customized coverage for gender-affirming procedures. We work closely with our plan sponsors to meet their unique needs and preferences while complying with all applicable regulations and legal requirements,” the statement continued. “We strongly disagree with the allegations in this lawsuit and will defend ourselves vigorously.” 
  • Here’s a link to the Leapfrog CEO Leah Binder’s statement about the Tenet Healthcare decision mentioned in yesterday’s post.
  • Per a Justice Department news release,
    • “The Department of Justice released today the first-ever Department-wide corporate enforcement policy for criminal matters, promoting uniformity, predictability, and fairness in how it pursues white-collar cases to protect the American people.”

From the public health and medical / Rx research front,

  • Bloomberg Law reports,
    • “South Plains, Texas, had long declared its measles outbreak over when in January wastewater testing picked up what Zachary Holbrooks called “a blip, a spike.”
    • “The testing found measles after months without traces of the virus, which by the 2025 West Texas outbreak’s end infected over 750 people, hospitalized nearly a hundred, and two children died.
    • “With samples sent to Baylor University weekly, subsequent testing hasn’t picked up further traces, said Holbrooks, executive director for the South Plains Public Health District. The goal is to “test long-term” and see “if anything shows up.”
    • “With the Centers for Disease Control and Prevention reporting over 1,200 confirmed measles cases and 12 new outbreaks in 2026, states across the US are taking similar steps to those taken in West Texas to manage infections, mounting outreach strategies, easing access to vaccines, and more.
    • “Working against such efforts are low vaccination rates in pockets of states where misinformation and distrust of government spur outbreaks.
    • “Any state should be looking across its communities and identifying areas where the vaccination rates are lower than 95%. Those are the places that are very ripe for outbreaks,” said Jennifer Nuzzo, director of Brown University’s Pandemic Center.”
    • “Given 2025’s outbreak cycle, states should’ve been better prepared, Nuzzo said. Now, they’ll need to undertake “the very slow, laborious ground game of building trust” in communities to encourage vaccination.”
  • The latest issue of NIH’s Research Matters covers the following topics:
  • Healio relates
    • “Adults with type 2 diabetes who adhered to eight healthy lifestyle habits had a 60% lower risk for cardiovascular events than those who reported zero or one healthy lifestyle habits, researchers reported.
    • “In a prospective cohort study of adults with type 2 diabetes enrolled in the U.S. Veterans Affairs Million Veteran Program, researchers assessed the risk for major adverse CV events according to the number of self-reported healthy lifestyle habits for each participant. The risk for CV events declined with each additional lifestyle habit a person reported, and the findings were similar regardless of whether adults were using a GLP-1 receptor agonist.”
  • and
    • “Risks for cognitive impairment increased with more advanced chronic kidney disease (CKD) stages. 
    • “Associations were strongest for higher urinary protein-to-creatinine ratio plus lower eGFR. ***
    • “Our findings suggest that measures of CKD severity may be relevant to consider in combination with known dementia risk factors, such as age or comorbid conditions,” [Tanika} Kelly [PH.D, MPH] told Healio. “Cognitive screenings should be considered if a patient or family member notice cognitive or behavioral changes.”
  • Health Day informs us,
    • “People think of aging as a steady decline, with seniors gradually losing their physical abilities and mental agility as the years wear on.
    • “But a new study suggests that seniors can – and often do – improve over time, with the right mindset.
    • “Nearly half of seniors 65 and older showed measurable improvement in their brain health, physical function or both over time, researchers reported in the journal Geriatrics.
    • “Many people equate aging with an inevitable and continuous loss of physical and cognitive abilities,” lead researcher Becca Levy, a professor of social and behavioral sciences at the Yale School of Public Health, said in a news release.
    • “What we found is that improvement in later life is not rare, it’s common, and it should be included in our understanding of the aging process,” Levy said.”
  • and
    • “Smoking weed, taking a hit of cocaine or popping some amphetamines can raise a person’s risk of stroke – even if they’re a younger adult.
    • “Coke and amphetamines can double or triple the risk of stroke for any adult, researchers reported in the International Journal of Stroke.
    • “Weed also increases stroke risk, but to a lesser extent, British researchers said.
    • “This is the most comprehensive analysis ever conducted on recreational drug use and stroke risk and provides compelling evidence that drugs like cocaine, amphetamines, and cannabis are causal risk factors for stroke,” lead researcher Megan Ritson said in a news release. She’s a postdoctoral research associate with the University of Cambridge.”
  • Cigna, writing in LinkedIn, discusses how employers can help improve the mental health of their male employees.
    • “Men face unique barriers to seeking mental health support, including stigma, societal expectations, and concerns about confidentiality at work.
    • “Untreated mental health conditions among men contribute to higher healthcare costs, absenteeism, and turnover.
    • “Employers that normalize mental health conversations, protect privacy, and offer tailored support men’s mental health can improve outcomes for employees and business performance.”
  • STAT News notes
    • “Several years ago, nephrologists attempted a first-of-its-kind effort: remove race from a key clinical algorithm, and attempt to undo the harms of the race-based equation for those who were still being negatively affected by it. 
    • “Until 2021, eGFR, which is used to measure kidney function, was inflated by around 16% to 21% for Black patients — which could mask severe kidney disease and delay urgently needed transplants. Not only was the equation phased out in 2022, but the Organ Procurement and Transplantation Network mandated that transplant programs submit modifications for Black patients waiting for transplants. 
    • Several years ago, nephrologists attempted a first-of-its-kind effort: remove race from a key clinical algorithm, and attempt to undo the harms of the race-based equation for those who were still being negatively affected by it. 
    • Until 2021, eGFR, which is used to measure kidney function, was inflated by around 16% to 21% for Black patients — which could mask severe kidney disease and delay urgently needed transplants. Not only was the equation phased out in 2022, but the Organ Procurement and Transplantation Network mandated that transplant programs submit modifications for Black patients waiting for transplants. 
  • and
    • “Vertex said Monday that a drug it secured as part of a $4.9 billion acquisitionsuccessfully reduced by half a key marker of a kidney disease known as IgA nephropathy.
    • “The results, from a Phase 3 trial, match data from a study of Otsuka’s recently approved Voyxact and are numerically superior to data released last year by Vera Therapeutics.
    • “All three companies have been racing to treat a disease that affects 330,000 people across the U.S. and Europe, according to Vertex’s estimates, putting many at risk of developing end-stage renal disease. Analysts have projected Vertex’s drug could eventually bring in $4 billion or more in annual sales.” 

From the HIMSS conference front,

  • Health Tech Magazine reports,
    • The HIMSS Global Health Conference and Exhibition is back in Las Vegas this year, with the tagline “Expert Insights, Exceptional Impact.” 
    • The annual conference kicks off Tuesday with an opening keynote from venture capital leader Jon McNeill (whose experience includes Tesla and Lyft) and Dr. John Halamka, the Dwight and Dian Diercks President of the Mayo Clinic Platform. 
    • Other notable keynote speakers throughout the week include Sumbul Ahmad Desai, vice president of health and fitness at Apple, on Wednesday; and Dr. Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, on Thursday (the final day of the conference). 
    • Before HIMSS 2026 began in full swing, Monday saw a day of preconference sessions organized around topics such as artificial intelligence in healthcare, cybersecurity, interoperability and health information exchanges, among others. 
    • The AI in healthcare preconference track saw healthy attendance with a focus on tangible use cases and lessons on how to deploy AI into improved or better-integrated workflows.
  • Heathcare Dive digs into regulation of artificial intelligence issues.
  • MedCity News adds,
    • “Verily and Samsung are teaming up to accelerate clinical research using wearable data, the companies announced Monday at the HIMSS conference in Las Vegas. 
    • “The companies are integrating user data from Samsung Galaxy smartwatches into Verily’s precision health platform, Verily Pre, so pharma companies and government agencies can run studies and monitor participants remotely.
    • “Researchers will be able to collect continuous health data from study participants wearing Samsung watches, including metrics such as heart rate, sleep and physical activity. The information will flow back into Verily’s data platform, allowing pharma companies and regulators to track patients’ health over time and quickly analyze real-world data.
    • “Consumer wearables are becoming “real, bonafide research-grade instruments,” according to Myoung Cha, Verily’s chief product officer.” 
  • In related news, “Ratnakar Lavu, chief digital information officer at Elevance Health, sat down with MobiHealthNews for an in-person interview to discuss the framework the health insurance company uses to validate and scale AI in healthcare.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Centene’s stock took a nosedive on Tuesday as the company’s top brass offered further color on the marketplace headwinds battering its performance.
    • “CEO Sarah London said during the Barclays Global Healthcare Conference that membership in its Affordable Care Act exchange plans was down to 3.6 million as of February, from 5.5 million at the end of 2025. She said the team expects that to decline further to about 3.5 million by the end of Q1.” * * *
    • “The company had braced for a likely downturn in enrollment following the expiry of the enhanced premium tax credits and the planned implementation of program integrity measures that proved controversial in the industry.” * * *
    • “Given that these shifts are driven in part by the end of the enhanced subsidies, London said that the member mix in the bronze tier does look different than in years past. Prior to the rollout of the enhanced subsidies in response to the pandemic, the bronze tier was largely made up of younger, healthier individuals.
    • “Now, the insurer is seeing people select a bronze plan because it’s a lower cost option to ensure they maintain coverage, even if they were previously in a silver or gold plan, she said.”
  • Modern Healthcare relates,
    • “Elevance Health is expanding [to California] a policy to penalize hospitals that refer patients to out-of-network providers. [The purposes of this sensible policy is to reduce No Surprises Act claims.}
    • “The insurance company has introduced the policy in at least 11 other states. 
    • “The American Hospital Association and Federation of American Hospitals have pushed back against the policy.”
  • Beckers Hospital Review tells us,
    • “Private equity firms have become a major force in healthcare, investing more than $1 trillion over the last ten years, according to a recent report from New York University’s Stern Center for Business and Human Rights.
    • “The report, published March 10 and authored by Michael Goldhaber, examines how private equity’s investments have impacted patient care, hospital finances and medical access.
    • “There is a healthcare crisis in the United States. Costs are rising, driven by market consolidation, increased insurance premiums, escalating drug prices and other changes,” the report said. “Many hospitals and healthcare facilities are experiencing staffing shortages. These and other factors mean that the poorest people in the U.S. have worse health outcomes than those in other high-income countries, despite the high level of spending.”
  • Fierce Healthcare adds,
    • “Highly concentrated—and, by extension, less economically competitive—hospital markets are ubiquitous across the country and the norm in rural states Wyoming, North Dakota and South Dakota, according to a market analysis tool unveiled this week by Yale University’s recently launched Health Care Affordability Lab.
    • “Every hospital in those three states operates in a market deemed to be highly concentrated or even monopolistic based on their Herfindahl-Hirschman Index (HHI), a metric used by the “Federal Trade Commission (FTC) and the Department of Justice (DOJ) to determine when it should intervene in a deal on competitive grounds. 
    • “More broadly, the tool shows that 94% of the nation’s hospitals operate in markets with HHIs above 1,800, reflecting a highly concentrated market.” 
  • BioPharma Dive lets us know,
    • “Ugur Sahin and Özlem Türeci, who co-founded BioNTech and led its rise to prominence as a COVID-19 vaccine maker, are leaving the company to establish a new startup focused on mRNA technology. 
    • “BioNTech said Tuesday that Sahin and Türeci, who’ve been serving as CEO and Chief Medical Officer, respectively, will step down by the end of the year. Afterwards, they’ll steer a startup working on “next-generation mRNA innovations.” BioNTech will grant that unnamed biotech certain rights to its mRNA technology in exchange for a minority stake, but won’t provide ongoing capital support, the company said.
    • “BioNTech, meanwhile, will focus on advancing a late-stage portfolio that now includes several different cancer medicines. The company said its supervisory board has initiated a search to identify successors for Sahin and Türeci and ensure a “smooth transition.” It’ll provide more details on the partnership with the new startup once an official deal is signed. Paperwork should be completed by the end of the first half.”
  • Beckers Hospital Review points out,
    • “Statista, a global data company that publishes insights for 170 industries, projects four cancer therapies will be among the top 10 best-selling pharmaceutical products in the U.S. this year. 
    • “The company projects Merck’s cancer drug Keytruda will earn $12.7 billion in U.S. revenue in 2026 — nearly twice that of the second top-selling medication, according to data shared March 9 with Becker’s. 
    • “[The article identifies] the medications Statista projects will be the 10 best-selling U.S. pharmaceutical products in 2026.”
  • Fierce Pharma notes,
    • “Sandoz has not minced words about the massive yet largely untapped opportunity biosimilar makers are presented with as dozens of branded medicines inch toward the patent cliff in the next decade. 
    • “Now, in an effort to fully capitalize on what the company recently referred to as a potential “‘golden decade’ of affordable medicines” after 2030, Sandoz is committing even further to its biosimilar business with plans to launch a dedicated unit that will operate separately from the company’s remaining small molecule generics division.”
    •  “The new biosimilar unit, focused on development, manufacturing and supply of copycat biologic drugs, will be led by Armin Metzger, most recently chief technical operations officer at fellow Swiss drugmaker Ferring Pharmaceuticals.”
  • Per MedTech Dive,
    • “Medtronic said Tuesday it agreed to acquire neurovascular technology company Scientia Vascular for $550 million, with the potential for undisclosed milestone payments after the acquisition.
    • “Scientia’s neurovascular access devices are used to navigate the brain’s complex vasculature to treat conditions such as strokes and aneurysms.
    • “The Scientia proposal is Medtronic’s second deal of the year, after the company announced an acquisition of CathWorks for up to $585 million in February.”

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.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Govexec.com reports,
    • “While the Homeland Security Department is shut down, the vast majority of employees—about 92%—are still reporting to work. In some cases, however, workers are finding creative solutions to get out of their regular duties and save money while their paychecks hang in the balance. 
    • “My unit is rotating voluntary furlough days,” said one DHS staffer.  “Workers in that office are taking turns to take time off work, which, during a shutdown, entails being placed in an unpaid furlough status. 
    • “[We] conserve finances by not commuting, since we’re only allowed to telework in emergency situations,” the employee said, noting some employees in the unit commute 80 miles per day and are therefore seeing significant savings on gas when they do not go to work. The employees who accept the furloughs have used the time to schedule medical appointments, handle errands or tackle home projects.” * * *
    • “Most DHS employees will not miss a full paycheck until the beginning of March. Craig Carter, president of the Federal Managers Association, said the impacts are already being felt across the DHS workforce.” 
  • The OPM Office of Inspector General has posted its semi-annual report to Congress for the period ended September 30, 2025. Here is a link to the OPM management’s response to this report.
  • Legistorm tells us about GAO report number GAO-26-107169 which was issued yesterday.
    • “What GAO Found
      • “The No Surprises Act, among its provisions, generally prohibits providers from balance billing in certain circumstances—such as emergency services—for individuals with private health insurance. Balance billing is when insured patients receive a bill from an out-of-network health care provider for the amount above any applicable cost-sharing that exceeds the health plan or issuer’s payment. An unexpected balance bill is referred to as a surprise bill.
      • “GAO analyzed the percentage of claims that were in-network for selected specialties to examine potential changes in network participation after the act’s implementation. Increases in the percentage of in-network claims may indicate increases in provider participation, while decreases may indicate reduced participation.
      • “Among specialties likely to be affected by the No Suprises Act protections—emergency medicine, radiology, anesthesiology, and air ambulance—the percentage of in-network claims increased for three of the four specialties after the act took effect. For example, GAO found the percentage of in-network facility claims (typically submitted by hospitals) and professional claims (typically submitted by physicians) for emergency medicine declined before the No Surprises Act took effect, then increased afterward.
      • “Payment changes for the selected services largely reflected continuations of trends prior to the No Surprises Act taking effect. For example, the inflation-adjusted payment for in-network emergency medicine services billed by facilities increased in 2022 and 2023, continuing the trend since 2019. Meanwhile, the inflation-adjusted payment for in-network emergency services billed by physicians or their practices decreased in 2022 and 2023, continuing previous trends.”
    • FEHBlog note: This is encouraging news.
  • NCQA writes in LinkedIn
    • “NCQA has updated its State of Health Care Quality Report to include data for HEDIS® Measurement Year (MY) 2024. This free resource, available on the NCQA website, offers valuable insight into healthcare quality performance nationwide.
    • “You can use this report to:
      • “Learn more about each quality measure, how it is defined and why it matters.
      • “Access national averages and historical trends for over 90 measures of clinical quality and patient satisfaction.
      • “Compare performance across different products, like Commercial, Medicare and Medicaid.
      • “We will add data for MY 2025 in February 2027, or you can get it sooner through NCQA’s Quality Compass®.
    • “The report is available through this link. You can also find a link to the report on the HEDIS Measures and Technical Resources web page.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Tracy Beth Høeg, the top drug regulator at the Food and Drug Administration, indicated in her first address to staff that she’ll scrutinize antidepressants and the shots used to protect babies from RSV.
    • “Høeg told employees on Thursday that her top priorities include two issues she’s focused on in the recent past: evaluating the safety of antidepressants taken by pregnant women and of monoclonal antibodies that protect infants against RSV.
    • “I’ve been interested to learn we really haven’t been doing sort of thorough safety monitoring of these products during pregnancy, and so I think we could do a better job,” Høeg said. “I actually think that there’s agreement about that, and among the CDER staff that I’ve been working with on this issue, so I’m excited to see that.”
    • “Høeg also discussed her interest in vaccine policy, and mentioned she’d like to “bring that interest” into the drug center.”
  • Radiology Business relates,
    • “GE HealthCare has secured three notable new MRI clearances from the U.S. Food and Drug Administration. 
    • “On Thursday, the company announced the clearance of two MRI systems, Signa Sprint with Freelium and Signa Bolt, and one artificial intelligence-enabled workflow platform. Each of the three cleared produts were designed with the rising demand for MR imaging in mind, according to the company’s president and CEO of MR, Kelly Londy. 
    • “Achieving FDA clearance of our next-generation Signa MRI technology underscores our commitment to expanding access to high-quality imaging and elevating the standard of care for patients everywhere,” Londy said in an announcement. “As MRI demand continues to rise across clinical areas, providers need solutions that deliver greater efficiency without compromising diagnostic precision.”
  • BioPharma Dive informs us,
    • “Roche said Friday that the Food and Drug Administration will decide by Dec. 18 whether to approve its experimental drug giredestrant in breast cancer, setting the stage for a verdict that could intensify the competition surrounding a new class of oral, tumor-fighting medications.  
    • “Roche’s submission was based on the results of a Phase 3 study that found giredestrant superior to older hormone therapies at keeping people with a certain type of advanced breast cancer alive without their disease getting worse. The pill has also since proven helpful to people in the “adjuvant” setting after surgery. 
    • “If approved, giredestrant would become the third new oral “SERD” on the market, following clearances for Menarini Group’s Orserdu and Eli Lilly’s Inluriyo. Roche believes giredestrant has the potential to stand out from its competitors, but faces persistent doubts about the class’ commercial outlook.”

From the judicial front,

  • The American Hospital Association News reports,
    • The Supreme Court Feb. 20 ruled [in a 6-3 opinion written by the Chief Justice] that the International Emergency Economic Powers Act [of 1977] does not authorize the imposition of global tariffs. The court held that IEEPA does not provide the president with “the independent power to impose tariffs on imports from any country, of any product, at any rate, for any amount of time.” The court did not address whether the government will have to refund the tariff revenue or what other legal authorities the president may have to impose similar tariffs. [The Court remanded those decisions to the lower courts.]
  • Bloomberg Law reports,
    • “The FTC has asked a federal appeals court to revive requirements for companies to divulge more information to US antitrust regulators ahead of potential mergers.
    • “The Federal Trade Commission Wednesday appealed a Feb. 12 decision from a US district court judge in Texas blocking a 2024 Biden-era rule. The case is pending in the US Court of Appeals for the Fifth Circuit.
    • “The regulation updated a decades-old US pre-merger notification program to require companies share more about overlapping business lines and ownership structures, among other details. Companies seeking combinations valued at $133.9 million or more must undergo an initial 30-day review by the FTC and Justice Department under the notice system.”
  • and
    • “The [U.S. Court of Appeals for the] First Circuit rejected a lawsuit accusing Cigna Health & Life Insurance Co. of obesity discrimination, shutting down an attempt to broaden coverage of blockbuster GLP-1 weight-loss drugs.
    • “Pressure to cover the drugs is growing for insurers and employers as their uptake among the general public increases. One in five adults has taken a GLP-1 drug at some point, according to a November 2025 poll from health-care think tank KFF.
    • “The US District Court for the District of Maine previously dismissed Jamie Whittemore’s case, along with a similar case against Elevance Health Inc. The district judges determined that Whittemore didn’t prove that obesity qualified her as disabled.” * * *
    • “Here, even if Whittemore plausibly alleged that obesity is a physical impairment, she failed to allege sufficient facts to support an inference that her obesity substantially limits her major life activities,” Judges Lara E. Montecalvo, Sandra L. Lynch, and Ojetta Rogeriee Thompson wrote in their opinion Thursday.”
  • Per a Justice Department news release,
    • “The Justice Department’s Antitrust Division, together with the Attorney General of Ohio, filed a civil antitrust lawsuit today challenging OhioHealth Corporation’s (OhioHealth) anticompetitive contract restrictions that force Ohio patients to pay higher prices for healthcare.
    • “The complaint, filed in the U.S. District Court for the Southern District of Ohio, seeks to enjoin OhioHealth, the largest healthcare system in central Ohio, from enforcing its anticompetitive contractual terms and continuing to suppress healthcare competition.”
  • Per Beckers Payer Issues,
    • “An insurance brokerage president and the CEO of a marketing company were each sentenced to 20 years in prison for their roles in a scheme to fraudulently enroll individuals in subsidized ACA plans to obtain commission payments from insurers.”

From the public health, medical and Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated and increasing in some areas of the country. Emergency department visits for RSV are highest among infants and children less than 4 years old. RSV hospitalizations 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; however, trends vary by region.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits among infants and children 4 years and younger. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Feb. 19 released a report on the low use of COVID-19 antiviral drugs among individuals age 65 and older, a population at high risk of severe illness from the disease. The report found that from June 2023 through September 2025, 16%-23% of COVID-19 patients older than 65 received an antiviral prescription during low occurrences of COVID-19, compared to 37%-38% during higher occurrences. Adults ages 75-84 and 85 and older were more likely to receive an antiviral prescription than those ages 65-74. “COVID-19 vaccination and treatment can prevent severe COVID-19 among older adults,” the CDC wrote. “Efforts to improve health care provider and patient knowledge regarding the benefits of COVID-19 vaccination and antivirals, especially for older adults, are needed to reduce the risk for severe illness and death.”
  • The University of Minnesota’s CIDRAP adds,
    • “Two studies examined the effects of COVID-19 vaccination in pregnancy, with one estimating that full vaccination and a booster dose reduce the risk of preeclampsia (PE) by 15% and 33%, respectively, and the other finding no elevated risk of miscarriage before 20 weeks’ gestation among pregnant or soon-to-be-pregnant recipients of the Pfizer/BioNTech or Moderna vaccines.”
  • The CDC also announced,
    • “As of February 19, 2026, 982 confirmed* measles cases were reported in the United States in 2026. Among these, 976 measles cases were reported by 26 jurisdictions: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Minnesota, Nebraska, New York City, 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 7 new outbreaks** reported in 2026, and 89% of confirmed cases (870 of 982) are outbreak-associated (73 from outbreaks starting in 2026 and 797 from outbreaks that started in 2025).”
  • The University of Minnesota’s CIDRAP adds,
    • “Utah has confirmed 300 measles cases in an ongoing outbreak, with the virus now spreading in Salt Lake County and new exposures at high schools in that county, according to an update yesterday from the Salt Lake County Health Department (SLCoHD).
    • “The first measles symptoms are often cold- or flu-like, with cough, runny nose, red/watery eyes, and fever, so you may think you have a common respiratory illness and can continue engaging in normal activities,” said Dorothy Adams, executive director of SLCoHD. “But please stay home if you have any signs of illness, especially now that we know measles is actively circulating in our community.”
  • Per the AHA News,
    • “The ongoing measles outbreak in South Carolina has reached 973 cases, the state’s Department of Public Health reported Feb. 20. Of those, 906 cases are unvaccinated, 26 are fully vaccinated, 20 are partially vaccinated and the vaccination status of 21 cases is unknown. Nationally, 982 confirmed measles cases across 26 jurisdictions have been reported to the Centers for Disease Control and Prevention since Jan. 1. The CDC said there have been seven outbreaks reported in 2026 and that 89% of confirmed cases are outbreak-associated.” 
  • Cardiovascular Business informs us,
    • “The American College of Cardiology (ACC) and American Heart Association (AHA) have developed their first clinical practice guidelines focused on the treatment and management of acute pulmonary embolism (PE). The new document, published in full in JACC and Circulation, highlights the importance of diagnosing patients as quickly as possible and determining the best course of action.
    • “A PE is a potentially fatal blood clot that travels through the heart and then becomes lodged in an artery in the lungs. Treating PEs quickly—and effectively—can help minimize the patient’s risk of death and cardiac arrest. Anticoagulants are the most common PE treatment, but catheter-based interventions and surgery may be necessary for more severe cases.
    • “There have been significant advances in the understanding of PE and treatments to effectively manage this condition,” Mark A. Creager, MD, chair of the document’s writing committee and director emeritus of the Heart and Vascular Center at Dartmouth Health, said in a statement. “This guideline is a road map to help clinicians navigate these advances for the safest and most effective approaches to care for people with this condition.”
  • Per Radiology Business,
    • “New research highlights the potential for a PET- and MRI-based imaging approach for differentiating a new type of dementia from Alzheimer’s disease. 
    • “Limbic-predominant age-related TDP-43 encephalopathy, also known as LATE, was recently recognized as a type of dementia that occurs in older adults, typically presenting as memory-related cognitive decline. Due to its impact on memory, it is often mistaken for AD. 
    • “However, both LATE and Alzheimer’s present differently on imaging. While AD is identified due to the accumulation of amyloid and tau proteins on the brain, LATE involves clumps of the protein TDP-43 in the limbic system. It is important to differentiate between the two due to the differing treatment methods for each. 
    • ‘A new paper in the Journal of Nuclear Medicine describes how combining PET and MRI imaging data can help distinguish between the two in living patients. 
    • “The distinction in the causes of these types of dementia is critical, especially in the era of anti-amyloid therapies,” Satoshi Minoshima, MD, PhD, professor of radiology and imaging sciences at the University of Utah, Salt Lake City, said in a news release. “Because LATE has a different underlying pathology and a seemingly different prognosis, it cannot be diagnosed or treated in the same way as Alzheimer’s disease.” 
  • The University of Connecticut, the FEHBlog’s alma mater, writes in LinkedIn about research on Parkinson’s Disease treatments.
  • Per BioPharma Dive,
    • “Grail’s multi-cancer early detection test failed to meet its primary endpoint in a key study, sending the company’s shares tumbling about 50% in Friday trading.
    • “The NHS-Galleri trial evaluated annual screening with the Galleri MCED test in England’s National Health Service over three years in 142,000 asymptomatic participants aged 50 to 77.
    • “Grail said the study aimed to show testing could help reduce late-stage cancer diagnoses and increase detection rates to support national screening in England. A U.S. premarket approval application for Galleri, submitted earlier this month, includes data from the trial on test performance, clinical validation and benefit of detection at stages I through III, including reduction in stage IV cancer diagnoses, the company said.”
  • Per Health Day,
    • “An ancient Chinese mind-body practice can lower a person’s blood pressure as well as medication or a program of brisk walking, a new study says.
    • “Baduanjin is a widely practiced eight-movement sequence that combines slow, structured movement, deep breathing and meditation.
    • “The practice lowered people’s blood pressure by about 3 to 5 points, similar to benefits sustained by people asked to take up walking, according to clinical trial results published Feb. 18 in the Journal of the American College of Cardiology.”
  • Per Genetic Engineering and Biotechnology News,
    • “Stanford Medicine researchers and collaborators have developed a universal vaccine candidate that studies in mice suggest protects against a wide range of respiratory viruses, bacteria, and even allergens. Unlike any vaccine used today, the new vaccine, delivered intranasally, was found to provide broad protection in the lungs for several months. The novel vaccination strategy integrates the two branches of immunity—innate and adaptive—creating a feedback loop that sustains a broad immune response.
    • “The research team, headed by Bali Pulendran, PhD, the Violetta L. Horton Professor II, director of the Institute for Immunity, Transplantation and Infection, and a professor of pathology, microbiology and immunology at Stanford University, demonstrated that vaccinated mice were protected against SARS-CoV-2 and other coronaviruses,  Staphylococcus aureus and Acinetobacter baumannii (common hospital-acquired infections), and house dust mite allergen. Pulendran said the new vaccine has worked for a remarkably wide spectrum of respiratory threats that the researchers tested. Speaking to GEN, Pulendran emphasized that the reported work is preclinical, and the team’s goal is to translate their research carefully and responsibly. “If it ultimately proves safe and effective in humans, the potential impact could be transformative: simplifying seasonal vaccination and improving readiness for emerging respiratory threats,” Pulendran said.”

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

  • Beckers Payer Issues reports,
    • “Medicare Advantage now covers about 55% of eligible beneficiaries nationwide — more than 35 million people — but health systems are confronting a question that until recently felt almost taboo: What happens when participation in the country’s fastest-growing Medicare program no longer makes financial sense?
    • “Over the past three years, Becker’s has reported on roughly 90 hospitals and health systems that have terminated some or all of their commercial Medicare Advantage contracts. In 2026 alone, at least 15 systems have gone out of network with one or more Medicare Advantage plans, and the trend is showing no signs of slowing down. 
    • ‘This year, 1 in 10 Medicare Advantage enrollees — about 2.9 million people — will be forced to disenroll from their plan following a spike in plans exiting the market, according to a Feb. 18 study published in JAMA.
    • “Behind many of those decisions lies what Scripps Health CFO Brett Tande describes as a classic “sunk-cost” dilemma: after years of building infrastructure, staffing and strategy around Medicare Advantage, can systems realistically walk away — even when contracts are losing money?
    • “For a growing number of health systems, the answer is becoming clearer.
    • “Becker’s connected with executives from Providence, Scripps Health, Ascension, MemorialCare and Mayo Clinic to understand how they are reassessing their participation in Medicare Advantage and what that shift could mean for providers, payers and patients.”
  • Kaufmann Hall notes,
    • “Partnerships, like all relationships, are de facto collaborative. Certain success factors are well known, including the importance of cultural alignment, constant communication and effective post-closing integration. Based on our collective experience assisting health systems with the negotiation of strategic partnerships, we share other lessons learned that are important considerations. These are tangible steps that require intentional focus and may require hard choices during the partnership development process but are important for ensuring long-term success. We hope these “inside baseball” lessons and case studies are useful for organizations when negotiating their next strategic partnership.”
  • and
    • “Amazon last week announced it would expand its same-day pharmacy delivery service to 4,500 cities nationwide. The move expands Amazon’s market share against other drug delivery providers like Walmart and CVS Caremark. It adds same-day delivery services to 2,000 communities, including remote areas in Alaska, the Navajo Nation and islands only accessible by ferry and only navigable by horse-drawn carriage. The expansion demonstrates the retail giant’s ability to scale its logistics network in healthcare, offering faster access to medications compared with traditional mail-order pharmacies, which can take up to 10 days to deliver drugs.”
  • Behavioral Health Business relates,
    • “Madison Health Group (MHG) has announced its plans to purchase managed behavioral health provider Magellan Health.
    • “This comes roughly five years after payer giant Centene Corporation (NYSE: CNC) bought Magellan Health at a valuation of $2.2 billion.
    • ​”Magellan Health manages behavioral health services for health plans, employers and government agencies.
    • ​”Following the deal, Magellan will become an independent organization, with MHG’s backing to support innovation. Specifically, the new funds will be used to expand its clinical programs into new markets, leveraging “enhanced technology, AI, data and analytical solutions” for its clients, according to social media posts.”
  • Fierce Healthcare tells us,
    • “Carrot is expanding its parenting benefits with on-demand virtual pediatric care through Blueberry Pediatrics. 
    • “Carrot, a fertility and family-building benefits platform working with payers and employers, will offer Blueberry as an add-on. The new offering will be available to families with kids under 12. It is expected to roll out in the next few months. The offering will be covered by the plan sponsor, and members are not expected to incur out-of-pocket costs.
    • ‘Parents will have 24/7 access to on-demand virtual visits with board-certified pediatricians from Blueberry for common issues like ear infections, rashes, colds and the flu. Families can connect with pediatricians around the clock via secure messaging, video or audio. Members will also get a home medical kit with a wireless digital ear scope, pediatric pulse oximeter and thermometer. This will help Blueberry clinicians remotely assess children.”
  • Per Modern Healthcare,
    • “Early lessons are emerging as the digital health sector’s ambient AI focus shifts from clinical documentation to prior authorization.
    • “Companies such as Abridge, Suki and Cohere say their solutions can do for prior authorization what ambient AI has done for documentation and clinician burnout. The importance of partnerships become an integral part of their efforts in this area.
    • “In August, Abridge announced a partnership with Pittsburgh-based insurer Highmark Health and its integrated health system Alleghany Health Network to develop a tool that would approve prior authorization requests at the point of care. Prior authorization was the logical next step for Abridge after clinical documentation, said Clinical Strategy Principal Matt Troup.
    • “Six months in, the collaboration has shown the importance of building connections with providers and payers when developing ambient AI for prior authorization.
    • “[Our partnership] just gave us access to bring everyone to the table, to figure out, what we can possibly do in this space,” Troup said. “Is it actually possible to get these approvals in real-time, upstream in the conversation, if both the payer and provider are aligned on the impact that this can have in healthcare.” 

Midweek report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx resarch front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

  • Fierce Healthcare reports,
    • “Republicans on the House Judiciary Committee have subpoenaed eight insurers for documents outlining their measures to head off fraud related to Affordable Care Act subsidies.
    • “The information demands follow an attempt from the Trump administration over the summer to enact new guardrails on improper enrollments, which was paused by the courts amid ongoing litigation. The Republican committee heads said their inquiries could help unstuck that regulatory effort.: * * *
    • “The insurers who were sent a subpoena are: Blue Shield of California, Centene Corporation, CVS Health, Elevance Health, GuideWell, Health Care Service Corporation, Kaiser Permanente and Oscar Health.”
  • STAT News relates,
    • “File this under “If at first you don’t succeed…”
    • “The Trump administration is planning another attempt at creating a pilot program that would alter payments for medicines purchased through a controversial federal drug discount program.
    • “In a little-noticed posting, the Health Resources and Services Administration indicated it is pursuing a rule for a rebate model, although details were not disclosed.”
  • The American Hospital Association News tells us,
    • “The AHA Feb. 10 released its 2026 Rural Advocacy Agenda, laying out the association’s key priorities for Congress, the administration, regulatory agencies and courts. The agenda is focused on flexible payment models; ensuring fair reimbursement and access to capital; commercial insurer accountability; bolstering the workforce; and protecting the 340B Drug Pricing Program.”
  • The Washington Post informs us,
    • “The American Medical Association and a leading public health research group focused on vaccines are teaming up to create a system to review vaccine safety and effectiveness, mirroring a role long played by the Centers for Disease Control and Prevention.
    • “The groups, which will operate independently from the federal government, say their work is needed because the CDC’s vaccine review process has “effectively collapsed.” The parallel effort will initially focus on reviewing immunizations for influenza, covid-19 and respiratory syncytial virus, or RSV, ahead of the coming fall respiratory season.
    • “The groups will not be making vaccine recommendations but will provide the evidence reviews to state health officials, clinicians and others making vaccine decisions.
    • “The nation’s largest physician organization and the Vaccine Integrity Project at the University of Minnesota will convene leading medical professional societies, public health groups and health care organizations to “ensure a deliberative, evidence-driven approach to produce the data necessary to understand the risks and benefits of vaccine policy decisions for all populations — the approach traditionally used by the federal government,” according to a joint statement announcing the effort Tuesday.”

From the Food and Drug Administration front,

  • Radiology Business lets us know,
    • “A new MRI system designed specifically for imaging of neonates and infants has just been cleared by the U.S. Food and Drug Administration. 
    • “Cincinnati-based Eyas Medical Imaging announced the clearance of its Ascent3T on Thursday. Eyas cited the clearance as the first in the world for a 3T neonate-specific MRI system.  
    • “Cincinnati Children’s Hospital played a pivotal role in the scanner’s design and development. Experts there observed over 1,700 infant MRI scans on prototypes to get a better idea of how to design the system so it could achieve diagnostic quality in real-world settings.
    • “We took great care in the design of the Ascent3T. Our goal is to transform neonatal care by bringing an unprecedented level of MR imaging and access to the most vulnerable patients when and where they need it,” MR physicist Charles Dumoulin, PhD, a professor of pediatrics and radiology at Cincinnati Children’s and the founder of Eyas Medical Imaging, said in an announcement.”
  • The Wall Street Journal reports,
    • “The U.S. Food and Drug Administration refused to review Moderna’s application to sell a new seasonal flu vaccine.
    • “The FDA sent Moderna a “refusal-to-file” letter earlier this month, saying the company’s study testing the vaccine wasn’t sufficient, and the agency wouldn’t take up the company’s request for approval to sell the shot, Moderna said Tuesday.
    • “In the letter, the FDA said Moderna failed during testing to compare its experimental flu vaccine to the best available vaccine on the market.
    • “Moderna said the FDA didn’t identify any concerns about the safety or effectiveness of the company’s experimental vaccine. The company said it was asking the agency for a meeting to discuss the matter.”
  • Fierce Pharma adds,
    • “A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi.”
  • Per an HHS news release,
    • “The U.S. Food and Drug Administration today launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a chemical preservative used in food. The review will consider whether BHA is safe under its current conditions of use in food and as a food contact substance, based on the latest scientific information. As part of this re-assessment, the agency issued a Request for Information (RFI) on the use and safety of BHA.
    • “This is part of the FDA’s broader efforts to proactively review chemical additives in the food supply. In May 2025, the FDA launched a strengthened program to review chemicals currently in the food supply. FDA identified BHA as a top priority for review. The FDA’s post-market assessment of BHA used in food is one of several ongoing post-market assessments under the agency’s enhanced systematic process for scrutinizing chemicals in our food supply.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “There are 933 cases in the South Carolina measles outbreak, the state’s Department of Public Health reported Feb. 10. Of those, 859 cases are unvaccinated, 20 are partially vaccinated, 25 are vaccinated and the status of 29 cases is unknown. The agency said last week that in January there were more than 16,800 doses of the measles vaccine administered, a 72% increase compared to January 2025. The department said vaccination continues to be the best way to prevent measles and end the outbreak.”
  • The Wall Street Journal asks “Why Doctors Can’t Agree on How to Diagnose Alzheimer’s Disease.”
    • “Divergent diagnostic criteria is raising concerns that some patients are being misdiagnosed and unnecessarily treated.” * * *
    • “Dr. Gayatri Devi, director of Park Avenue Neurology in New York City, is a neurologist who says over the past year she has seen an increasing number of patients who were told they had Alzheimer’s disease when they didn’t. One patient, a human-resources executive, had erroneously been diagnosed with Alzheimer’s based on a faulty PET scan of his brain that had read positive for amyloid and his own fears of memory issues because he had missed an important meeting.” * * *
    • “Dr. Reisa Sperling is a neurology professor at Harvard Medical School who runs studies testing antiamyloid drugs in asymptomatic people with amyloid in their brain. She says the goal is early intervention. * * *
    • “She says the International Working Group’s criteria requiring cognitive impairment to diagnose Alzheimer’s disease is problematic, likening it to requiring someone with diabetes to wait until they have blindness or kidney failure to be diagnosed. “All disease begins before symptoms, and most diseases are better treated before people walk into your office with clear impairment,” Sperling says. 
    • “Devi says the psychological impact of being told you have Alzheimer’s when you don’t is profound. Until the medical community can better agree on how to both diagnose early Alzheimer’s disease and determine whether early treatment helps, patients should avoid unnecessary testing—especially with the advent of easily accessible blood tests.”
  • MedPage Today tells us,
    • “A large-scale, automated urinary incontinence (UI) screening and education program increased awareness, diagnosis, and treatment of the condition, researchers found.
    • “In a quality improvement study known as Identify, Teach, and Treat (IT2), Sarah Collins, MD, of the University of Chicago Pritzker School of Medicine, and colleagues asked women presenting for routine annual primary care visits a single question: “Do you have bothersome leakage of urine?”
    • “Those who answered “yes” were given the option to engage in an educational and interactive computer-based tool about UI and treatment options. Using the tool led to significant increases in practice-level rates of UI diagnosis and treatment, the researchers reported in JAMA Internal Medicine.”
  • Healio informs us
    • “Adolescents and young adults with type 1 diabetes who reported receiving help with managing their disease may have better glycemic outcomes as they transition from pediatric to adult care, researchers reported.
    • “In a study published in Diabetic Medicine, researchers analyzed baseline data from adolescents and young adults who enrolled in a randomized clinical trial to assess a behavioral intervention to support the transition from pediatric to adult care. After conducting four multiple regression models, researchers found that participants who said they received more help with managing their diabetes had better self-management skills and lower HbA1c.”
  • Per NIH news releases,
    • “National Institutes of Health (NIH) researchers have developed a digital replica of crucial eye cells, providing a new tool for studying how the cells organize themselves when they are healthy and affected by diseases. The platform opens a new door for therapeutic discovery for blinding diseases such as age-related macular degeneration (AMD), a leading cause of vision loss in people over 50.
    • “This work represents the first ever subcellular resolution digital twin of a differentiated human primary cell, demonstrating how the eye is an ideal proving ground for developing methods that could be used more generally in biomedical research,” Kapil Bharti, Ph.D., scientific director at the NIH’s National Eye Institute (NEI).”
  • and
    • “The National Institutes of Health (NIH) has stopped an investigational treatment arm of the Comparison of Anti-coagulation and Anti-platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) study ,following a regular review by the Data Safety and Monitoring Board (DSMB).
    • The DSMB is an independent group of experts that regularly check if the study is safe. NIH’s National Institute of Neurological Disorders and Stroke, the trial’s funder, accepted the DSMB recommendation that CAPTIVA discontinue the low-dose rivaroxaban arm of the trial due to an increase in safety events and evidence of futility, a pre-specified stopping point to enable the study to end if early results showed the treatment is unlikely to help people. Rivaroxaban is a U.S. Food and Drug Administration-approved anticoagulant medication used to treat or prevent blood clots.
    • All study sites that have active participants randomized to the discontinued arm have received instructions for drug discontinuation. Study participants who have completed their evaluation of the discontinued arm will be contacted by the site where they received treatment. Participant safety remains NIH’s top priority.
  • Per BioPharma Dive,
    • “In experimental eczema shot from Nektar Therapeutics helped trial enrollees who’d already benefited from treatment maintain and even deepen their response over one year after being switched to a longer-lasting maintenance dose, the company said Tuesday.
    • “The data, if confirmed in additional testing, could give Nektar’s shot a competitive advantage over Regeneron and Sanofi’s Dupixent and Eli Lilly’s Ebglyss by offering deepening effects with less-frequent dosing. But Nektar also faces competition from many others advancing different types of injectables and oral medicines for the condition. 
    • “Nektar is planning a Phase 3 trial with a similar design that will allow responders to transition to a maintenance dose while others continue on with the initial regimen. If successful, the company expects to ask the Food and Drug Administration for approval in 2029.”
  • and
    • “An experimental, dual-acting weight loss pill from Hengrui Pharma and Kailera Therapeutics will advance into further testing after succeeding in a mid-stage study in China.  
    • “The drug is an oral version of ribupatide, an injectable therapy the two have already brought into Phase 3 development. In a Phase 2 study in 166 participants, that pill helped spur an average of as much as roughly 12% weight loss over 26 weeks, compared to about 2% for placebo recipients. More than half of those on the highest dose lost at least 10% of their body weight, and around 38% achieved at least 15% weight loss.
    • “Most treatment-related side effects were gastrointesinal and mild to moderate in nature. At the top two doses tested, vomiting was reported in as many as 11.4% and 7.5% of recipients, and nausea in 22.7% and 20%, respectively. Hengrui will “rapidly” move the drug into a Phase 3 trial in China, while Kailera plans to start a global mid-stage trial this year, the companies said.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “CVS beat Wall Street’s expectations in the fourth quarter, but investors — unhappy that the healthcare giant didn’t change its outlook for 2026 — still sent CVS’ stock down after the company released results early Tuesday morning.
    • “Executives defended CVS’ 2026 guidance as achievable and indicative of the success of the company’s turnaround plan during a difficult time for insurers. The financial growth CVS outlined contrasts with some of its managed care peers, which expect revenue and earnings to contract this year.
    • “CEO David Joyner also said that CVS is in talks with the Federal Trade Commission in the agency’s high-profile lawsuit against major pharmacy benefit managers, following the FTC’s recent settlement with Cigna.” * * *
    • “Moreover, legislation passed earlier this month requiring more transparency and delinking compensation from drug prices in Medicare’s prescription drug benefit is manageable, and could lead to greater adoption of Caremark’s rebate-free model, Joyner said.
    • “What we’ve seen now is more clarity in terms of where the reform is coming from. The good news is, we know at least with the legislation how to operate and how to run our business,” Joyner said. “At least consistent with the PBM legislation, the tools that we’ve seen are essentially leaning into what we’ve been doing over the last couple years.”
  • Fierce Healthcare relates,
    • “With 2025 marking a “reset year for the industry,” Oscar Health put a focus throughout the year on setting the company up for the future, its top brass told investors Tuesday.
    • “Oscar’s insurance business is concentrated in the Affordable Care Act exchange market, and CEO Mark Bertolini said during the company’s fourth-quarter earnings call that plans across this space felt the squeeze as more Medicaid lives entered the pool and integrity measures drove changes in market dynamics.
    • “With that backdrop, Oscar priced its plans for 2026 to account for those program integrity changes, elevated utilization trends and higher morbidity among its membership, Bertolini said. He said the team also baked in an expectation that the advanced premium tax credits would run out as scheduled, which they did Jan. 1.
    • “We took decisive actions with a disciplined pricing, distribution and product strategy to go after profitable growth as competitors pulled back or exited the market,” he said.”
  • Kaufmann Hall tells us,
    • “Hospital performance settled into a “new normal” in 2025. Patient volumes continue to grow, and a persistent gap between gross and net operating revenue indicates an eroding payer mix and more uninsured patients.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.
    • “Key Takeaways
      • “Hospital performance settled into a “new normal” in 2025. While margins in 2025 were stronger compared to prior years, hospitals need to be strategic about diversifying services and managing expenses.
      • “Patient volumes continue to grow across all services. While outpatient volumes continue to increase, hospitals will likely have a greater proportion of high acuity patients with elevated costs of care.
      • “There is a persistent gap between gross and net operating revenue, alongside a rise in bad debt and charity care. This imbalance indicates an eroding payer mix, likely a higher proportion of government vs. private payers, and more uninsured patients.”
  • Beckers Hospital Review adds,
    • “The same financial pressures hospitals are facing are increasingly evident at the physician enterprise level, according to Kaufman Hall’s latest quarterly “Physician Flash Report,” which is based on data from more than 200,000 employed providers — physicians and advanced practice providers — across more than 100 specialties.
    • “Provider productivity continues to climb, even as reimbursement and compensation lag behind, according to the report. Provider productivity — measured by work relative value units per full-time equivalent — has increased 7% since 2023. Over the same period, provider compensation rose 6%, while reimbursement declined 1%, as measured by net patient revenue per provider wRVU.
    • “The imbalance is driving higher practice subsidies. 
    • “The median investment — or subsidy — per physician reached $315,358 in the fourth quarter of 2025, a 4% increase since 2023. Labor expenses also remain elevated, accounting for 84.4% of total physician practice costs.
    • “The amount of downstream revenue that a provider needs to generate to cover a practice’s investment is increasingly unsustainable in this current financial environment,” Matthew Bates, managing director and physician enterprise service line leader at Kaufman Hall, said in a Feb. 10 news release. “Providers are working more but are being paid less for their work. Patient demand is up, yet reimbursement is falling.”
  • Fierce Pharma points out,
    • “After ending 2025 with a strong fourth quarter, AstraZeneca management has doubled down on its ambitious “$80 billion by 2030” revenue target, outlining a roadmap to have more than 25 blockbuster medicines by the end of the decade.
    • “During AZ’s Q4 earnings call, CEO Pascal Soriot highlighted an “unprecedented catalyst-rich period.” With more than 100 ongoing phase 3 trials and over 20 late-stage readouts slated for 2026, AZ’s exec team used a big chunk of their time on the call taking inventory of key clinical programs.
    • “That large portfolio shows the value of diversification, again highlighting what Soriot called “low concentration risk.”
    • “It’s great to have one or two big products. [It] makes you very profitable and makes you look good,” Soriot said. “But if you lose one of those, as we’ve seen happen to some actors in the industry lately, it really becomes very painful, very quickly. So this diversification, both product-wise, but also geographically, is suddenly becoming more apparent as we drive growth through therapy areas but also through regions.”
    • “AZ capped 2025 with fourth-quarter revenues of $15.5 billion, which arrived slightly above analysts’ expectations, thanks mainly to the company’s oncology portfolio.”
  • Beckers Payer Issues ranks States by share of mental health treatment facilities that accept commercial insurance.
    • “Overall, 83% of mental health treatment facilities accept private insurance in the United States. 
    • “Wyoming has the greatest percentage of centers that take commercial insurance, whereas California and the District of Columbia have the lowest. 
    • “KFF reported the rate of mental health treatment facilities that accept various insurance types, relying on 2024 data from respondents. While a facility may report participation, not all facilities may be accepting new patients.”

Weekend update

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

Happy Super Bowl Sunday!

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Tuesday report

David Ermer–Congress, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NCQA, Patient safety, SCOTUS, Uncategorized–

From Washington, DC,

  • Federal News Network reports,
    • “The House [of Representatives] passed a spending package to end a short-term partial government shutdown and fund most federal agencies through the end of the fiscal year.
    • “The spending deal, which includes a two-week continuing resolution for the Department of Homeland Security, was passed by the Senate last Friday.
    • “President Donald Trump signed the spending package into law on Tuesday afternoon.” * * *
    • “The spending package includes language guaranteeing back pay to federal employees who were briefly furloughed during the partial shutdown.” * * *
    • “After Trump signed the spending plan into law, OPM directed furloughed employees to return to work.”
  • The Wall Street Journal notes,
    • Twenty-one Republicans voted against the package [on the final vote [217-214] for passage], largely hard-liners who wanted to use the spending package as a vehicle to tighten election procedures. Twenty-one Democrats—mostly a collection of appropriations-committee members and centrists—voted for it.
  • Fierce Healthcare adds,
    • “The legislation finalizes several key healthcare extenders including provisions of the Medicare telehealth program and Acute Hospital Care at Home waiver as well as major supplementary funding programs for rural hospitals and those with high proportions of government-covered patients. The bill provides a five-year extension of the Acute Hospital Care at Home program and a two-year extension for Medicare telehealth flexibilities. The telehealth provisions in the bill include removing Medicare’s geographic requirements for telehealth and expanding the types of practitioners able to furnish telehealth services for the government health program.
    • “The bill also introduces reforms to pharmacy benefit manager (PBM) practices, including elements that would prevent PBMs from tying compensation in Part D to the list price of drugs, and boost price transparency for employers in their PBM contracts.
    • “Other provisions in the bill require that Medicare Advantage plans provide accurate provider lists, addressing so-called “ghost networks” that have come under fire in recent years. It would also require that health systems establish unique identification numbers for outpatient services, allowing the Centers for Medicare & Medicaid Services to track pricing in these facilities.”
  • Rep. Jodey Arrington (R TX), the chairman of the House Budget Committes, writing in Real Clear Health, shares his vision of a second reconciliation bill that would focus on healthcare.
  • The HHS Office of Inspector General posted “Medicare Advantage Industry Segment-Specific Compliance Program Guidance.”
  • Per an AHIP news release,
    • “Public and private payers are delivering greater value to Americans and the health care system by advancing value-based care (VBC). AHIP, in collaboration with the Centers for Medicare & Medicaid Services (CMS), today released the results of the 2025 Alternative Payment Model (APM) Adoption Survey. The findings reaffirm the commitment of the federal government and private health plans to advance VBC and APM models that shift away from fee-for-service (FFS) models toward payment arrangements that reward quality, efficiency and improved patient outcomes.
    • “This year’s survey highlights how health plans continue to work hand-in-hand with providers to advance value-based care and drive meaningful improvement for patients. These innovative payment models reward outcomes, resulting in patient-centered, high-quality, coordinated care that is more affordable for Americans,” said Danielle Lloyd, MPH, AHIP’s senior vice president of private market innovations and quality initiatives for Clinical Affairs.” * * *
    • To view the full 2025 survey findings, click here.
  • NCQA announced today,
    • “Every year, NCQA seeks public comment about proposed changes to HEDIS Volume 2.
    • “Public comment is your opportunity to weigh in on the relevance, scientific soundness and feasibility of new and revised measures for HEDIS. Your feedback helps us determine changes to our programs, procedures and processes.
    • “This year’s public comment is open February 13–March 13.
    • We’d like input on:
      • Seven new HEDIS measures.
      • Revising three HEDIS measures.
    • “This year’s public comment will go live Friday, February 13, at 9:00a.m. ET.
    • “We’ll post the link and more details here, so check back on February 13.”
  • The Washington Post relates,
    • “The American Society of Plastic Surgeons has issued a broad recommendation against gender transition surgeries for youths, becoming the first major medical association in the United States to narrow its guidance on pediatric gender care amid a crackdown by the Trump administration.
    • “A statement sent Tuesday to the group’s 11,000 members and obtained by The Washington Post recommends surgeons delay gender-related chest, genital and facial surgery until a patient is at least 19 years old. Fewer than 1,000 minors in the United States receive such surgeries every year, according to research published in JAMA, the American Medical Association’s journal, and the vast majority of the procedures are mastectomies, not genital surgeries.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products. The agency said Abiomed found its Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices could display inaccurate information due to a malfunction of the differential pressure sensors. The company reported 22 injuries associated with the issue since Jan. 15.” 
  • MedTech Dive relates,
    • “Abbott received a warning letter from the Food and Drug Administration related to its FreeStyle Libre continuous glucose monitors.
    • “The warning letter, dated Jan. 23 and posted to the FDA’s website on Tuesday, concerns performance specifications and testing for the glucose sensors’ accuracy. An Abbott spokesperson wrote in an email that the company is implementing corrective actions and providing ongoing updates to the FDA.
    • “The warning letter does not affect Abbott’s ability to manufacture, market or distribute Libre products, wrote Leerink Partners analyst Mike Kratky and J.P. Morgan analyst Robbie Marcus.”
  • The Wall Street Journal informs us,
    • “AstraZeneca AZN said the U.S. Food and Drug Administration rejected an initial submission for its Saphnelo lupus drug in injection form, and vowed to work with the regulator to move forward with an updated application.
    • “The U.K. pharmaceutical company said Tuesday that the FDA issued a complete response letter, which indicates that a new drug application can’t be approved in its present form, regarding Saphnelo for subcutaneous administration. The company said it subsequently provided information requested in the letter and that it was committed to working with the FDA to progress the application as quickly as possible.
    • “A decision on the updated application is expected in the first half of 2026, AstraZeneca said.
    • “The drug, a treatment for the autoimmune disease systemic lupus erythematosus, is already approved as an intravenous infusion and that form of administration remains commercially available, AstraZeneca said.”
  • Fierce Biotech tells us,
    • “As the first CAR-T treatment for an autoimmune disease draws ever closer, officials at the FDA have signaled a willingness to support the development of these novel cell therapies with a flexible regulatory approach.
    • “While interested in CAR-T therapies’ potential to achieve durable, drug-free remission in serious autoimmune conditions, the FDA is equally wary of their “unpredictable long-term toxicity,” according to an article published Monday in the Annals of Internal Medicine.
    • “In the article, Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research, and two other regulators said that, recognizing the complexity of autoimmune conditions in terms of seriousness and type, the agency will work with CAR-T makers “on a case-by-case basis to encourage appropriate study populations in rheumatologic autoimmune disease.”
    • “Simultaneously, citing a need to monitor a drug’s effect on fertility, the FDA officials recommended that industry conduct long-term follow-up studies for CAR-T products in the autoimmune setting, “as is standard for genetic therapies and CAR T-cells for oncologic indications.”
    • “While the FDA “shares enthusiasm for this class of products,” it will “carefully shepherd” the advancement of clinical studies “focused on the development, durability, and long-term safety of CAR T-cell therapies,” the regulators wrote.”
  • STAT News lets us know, “AI could soon renew prescriptions without clinician help. Should the FDA make sure it’s safe? Doctronic claims its AI doctor doesn’t need FDA approval. Experts aren’t so sure.”

From the public health and medical / Rx research front,

  • Nature reports,
    • “Nearly 40% of new cancer cases worldwide are potentially preventable, according to one of the first investigations1 of its kind, which analysed dozens of cancer types in almost 200 countries.
    • “The study found that in 2022, roughly seven million cancer diagnoses were linked to modifiable risk factors — those that can be changed, controlled or managed to reduce the likelihood of developing the disease. Overall, tobacco smoking was the leading contributor to worldwide cancer cases, followed by infections and drinking alcohol. The findings suggest that avoiding such risk factors is “one of the most powerful ways that we can potentially reduce the future cancer burden”, says study co-author Hanna Fink, a cancer epidemiologist at the World Health Organization’s International Agency for Research on Cancer in Lyon, France.
    • “The study was published today in Nature Medicine.”
  • The American Journal of Managed Care relates,
    • “The majority (57.5%) of commercially insured patients had at least 1 chronic condition in 2024. The average allowed amount1 for a patient with no chronic conditions was $1590, whereas the average allowed amount for a patient with 1 chronic condition was nearly double ($3039). Of 44 common chronic conditions studied, hyperlipidemia, or high cholesterol, was the most common, with a crude prevalence2 of 21.2%. These and other findings are reported in a new FAIR Health white paper: Chronic Conditions in the United States: A Study of Commercial Claims.” * * *
    • “Many patients had more than 1 chronic condition. For example, 11.5% of patients had 2 conditions, and 9.1% had 3.
    • “Some chronic conditions frequently co-occur. In the commercially insured population, 33.4% of patients had hyperlipidemia, hypertension, obesity, or some combination of these, and 4.3% had all 3.3 Half the patients with any one of these conditions had more than 1.” * * *
    • “For the complete white paper, click here“
  • CNN tells us,
    • “Men develop a greater risk of cardiovascular disease years earlier than women — starting at around age 35, according to a new long-term study.
    • “The report, published Wednesday in the Journal of the American Heart Association, followed more than 5,000 adults from young adulthood and found that men reached clinically significant levels of cardiovascular disease about seven years earlier than women.
    • “Experts advise both men and women to monitor their heart health in early adulthood and to see their doctor regularly.
    • “Heart disease doesn’t happen overnight; it develops over years. One of the things I think oftentimes people aren’t aware of is that it can start really early in your 30s or 40s,” said study coauthor Dr. Sadiya Khan, professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine in Chicago.
    • “Even if you don’t have heart disease at that time, your risk can start at that time.”
  • MedPage Today adds,
    • “National data showed 79% of adults with hypertension didn’t have their blood pressure within the blood pressure goal recommended by guidelines.
    • “Most of those uncontrolled hypertension cases went untreated by blood pressure medication.
    • “These findings highlight a large gap in hypertension control that treating hypertension earlier and more intensively could address.”
  • The New York Times observes,
    • “For much of the 20th century and beyond, social scientists attributed a range of chronic mental health problems to dysfunction between infants and their mothers, who were categorized as overbearing, rejecting, domineering or ambivalent.
    • “But a team of researchers from Pennsylvania State University has found that at times the early parenting behavior of fathers may have a greater impact on children’s health.
    • “For a study published recently in the journal Health Psychology, the scientists observed three-way interactions between 10-month-old infants, their fathers and their mothers, and then checked in on the families when the children were 2 and 7.
    • “They found that fathers who were less attentive to their 10-month-olds were likely to have trouble co-parenting, instead withdrawing or competing with mothers for the children’s attention. And at age 7, the children of those fathers were more likely to have markers of poor heart or metabolic health, such as inflammation and high blood sugar.
    • “Mothers’ behavior did not have the same effect, said Alp Aytuglu, a postdoctoral scholar at Penn State’s College of Health and Human Development and an author of the paper.
    • “We of course expected that family dynamics, everybody in the family, fathers and mothers, would impact child development — but it was only fathers, in this case,” Dr. Aytuglu said.”
  • Per Health Day,
    • “More than one-quarter of young children experience persisting symptoms after concussion (PSaC), according to a study published online Jan. 26 in Pediatrics.
    • “Sean C. Rose, M.D., from The Ohio State University in Columbus, and colleagues assessed the frequency of PSaC after early childhood concussion and identified potential predictors of PSaC. The analysis included 235 young children (ages 6 months to <6 years) with concussion, 108 with orthopedic injury, and 75 community controls.
    • “The researchers found that at one month postinjury, PSaC were documented in 28 percent of children with concussion, higher than in the orthopedic injury group (10 percent) and the community control group (2 percent). PSaC were documented in just under one-quarter of children at three months postconcussion (24 percent) and 16 percent at 12 months. PSaC at one month postconcussion was predicted by total symptom burden in the emergency department (odds ratio, 1.108). There were no associations for age, loss of consciousness, receiving brain imaging in the emergency department, attending daycare or school, or parent education with PSaC.”
  • and
    • “The symptoms women experience on the verge of menopause could be vastly different from what they might expect, a new study says.
    • “Women in perimenopause – the time leading up to their final period, as well as the year after – expect to be plagued with hot flashes and night sweats.
    • “However, these women reported symptoms like exhaustion and fatigue far more frequently than those typically associated with menopause, researchers reported Jan. 28 in the journal Menopause.
    • “This study shines a light on how little we still understand about perimenopause and how much it affects people’s daily lives,” lead researcher Dr. Mary Hedges said in a news release. She’s a community internal medicine physician at the Mayo Clinic in Jacksonville, Florida.”
  • Per BioPharma Dive,
    • “An experimental obesity shot Pfizer got through a buyout of Metsera helped enrollees in a mid-stage trial lose significantly more weight than a placebo, spurring up to an 11% reduction over 28 weeks using a regimen that switched from a weekly to monthly dose after 12 weeks.
    • “When including only participants who completed the trial, the shot helped people lose up to 12 percentage points more of their body weight than those who received a placebo. Though cross-trial comparisons can be misleading, the results “look slightly inferior” to what was seen in testing of Eli Lilly’s blockbuster Zepbound at a similar timepoint, wrote Leerink Partners analyst David Risinger.
    • “Pfizer executives noted on a conference call that, going forward, they intend to test a far higher dose than they did in Phase 2 testing. Phase 3 trials starting later this year will involve a dose that’s double the highest one used in the Phase 2.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente and Renown Health have wrapped the paperwork on a deal forming an insurance and outpatient care joint venture in northern Nevada. 
    • “The arrangement announced last September (see below) represents an entry into the geographic market for Kaiser, the country’s largest nonprofit health system. It brings Hometown Health—an existing health plan run by Renown Health, a Reno-based, two-hospital nonprofit system—plus an existing primary care medical office under joint ownership. The partners have plans to open two more facilities in 2026, plus retail pharmacies in 2027. 
    • “This joint venture with Renown Health allows us to extend our value-based care model and nation-leading health outcomes to northern Nevada, in collaboration with Renown Health’s trusted local teams,” Greg Adams, chair and CEO of Kaiser, said in a Tuesday announcement. “Together, we will improve health outcomes; expand access to affordable, high-quality care; and serve the needs of this growing community.”
    • “Financial terms of the transaction were not disclosed.” 
  • and
    • “Primary care company Carbon Health filed for Chapter 11 bankruptcy relief in Texas. 
    • “The company, which offers both in-person care at nearly 100 clinics and virtual care services, said Monday it reached a restructuring agreement with its existing lenders that establishes a “clear path to recapitalization and new ownership.”
    • “Carbon Health intends to pursue a dual-track, court-supervised process that allows it to enter a Chapter 11 plan premised on a debt-for-equity exchange, and a post-petition marketing and sale process for all or a portion of its assets, the company said in a press release issued Monday.
    • “This structure is intended to maximize value while preserving flexibility as the process moves forward,” Carbon Health executives said.
    • “To implement the restructuring, Carbon Health and certain affiliates have filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas.”
  • Healthcare Dive relates,
    • “Humana is launching an artificial intelligence tool that aims to help its call center workers answer beneficiaries’ questions about their coverage, the insurer said Tuesday. 
    • “Agent Assist, developed in partnership with Google Cloud, can summarize conversations between workers and enrollees in real time while highlighting relevant information, like the member’s benefit and eligibility details and important context from the call, Chris Sakalosky, vice president of strategic industries at Google Cloud, said via email.
    • “The insurer began rolling out Agent Assist in October, and plans to implement the tool across Humana’s service centers this year.”
  • Per MedCity News,
    • “About 50 million people in the U.S. are affected by autoimmune disease, and about 80% of them are women. When women give birth, they often experience significant hormonal changes that can trigger new diagnoses or symptoms of autoimmune disease.
    • “That’s why WellTheory, a platform focused on autoimmune disease, launched a new program last week aimed at supporting women in the postpartum period.
    • ‘Atherton, California-based WellTheory treats autoimmune conditions such as Addison’s disease, celiac disease, multiple sclerosis and lupus. Using a collaborative care model, it partners with patients’ physicians to deliver personalized plans focused on nutrition, stress, sleep and movement. The company offers video sessions, unlimited expert messaging and diagnostics. It serves both employers and health plans.
    • “The new postpartum program includes personalized care plans and one-on-one support with autoimmune and hormonal health experts. WellTheory also provides advanced hormonal testing if appropriate, including assessment of sex hormones, cortisol levels and metabolites. This helps identify root causes of conditions like postpartum depression.”
  • Adam Fein writing in his Drug Channels blog lets us know,
    • “The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which track all U.S. spending on healthcare. (Links below.)
    • “We spent an astounding $5,278,588,000,000 on healthcare in 2024. Yes, that’s $5.3 trillion!
    • “Retail outpatient prescription drugs accounted for less than 9% of that total. More than half of net outpatient drug spending was paid by federal, state, and local government programs. Below, we delve into the spending trends, which reveal the impact of the Inflation Reduction Act (IRA) on Medicare spending, the boom in healthcare marketplaces, and the post-pandemic bust in Medicaid. 
    • “Contrary to what you might read, the government’s data show that drug spending growth was not driven by purportedly “skyrocketing” drug prices. In reality, nearly all of the increase in drug spending reflected higher utilization—more people treated, more prescriptions dispensed, and shifts among drugs dispensed—rather than higher net prices.”
  • Per Fierce Pharma,
    • “Armed with what CEO Robert Davis called the “broadest and widest pipeline we’ve had in years,” Merck is preparing for its post-Keytruda future with what it foresees as a host of major sales opportunities over the next decade.
    • “Thanks in part to its recent acquisitions of Verona Pharma and Cidara Therapeutics, the company sees new growth drivers delivering potential annual revenue of more than $70 billion by the “mid-2030s,” Merck said in its fourth-quarter and full-year earnings presentation (PDF).
    • “To put the $70 billion number into context, Davis pointed to the figure as being more than double the $35 billion Keytruda is expected to pick up during its peak sales year in 2028. The oncology superstar is slated for a loss of exclusivity (LOE) in 2028, and a growing pipeline of Keytruda biosimilars is already lining up to take a shot at the drug’s massive market.
    • “Our belief in our ability to have substantial growth once we get closer to the LOE is as high as it’s ever been,” Davis emphasized on a conference call. “And we’re not done.”
  • and
    • “During the first six months of Maziar Mike Doustdar’s tenure as Novo Nordisk’s CEO, the company enjoyed a run of positive momentum highlighted by the launch of its Wegovy pill and a recent stock-price runup. But investor optimism came to a sudden halt Tuesday as the company warned of significant sales and earnings declines in 2026.
    • “Tuesday, Novo put out word that it’s expecting sales and earnings to slide between 5% and 13% this year. In 2025, Novo generated sales growth of 10% and operating profit growth of 6%, the company said.
    • “A few factors are playing into the 2026 guidance. For one, the company said it’s expecting sales to decline in the U.S. amid “intensifying competition” and lower prices in some areas of its business. Novo is also warning of a sales hit from the recent “Most Favored Nation” pricing deal it struck with the Trump administration.
    • “The company is also forecasting a currency hit as the U.S. dollar has lost value against the Danish krone, Novo’s local currency.”
  • Per MedTech Dive,
    • “Medtronic plans to acquire CathWorks, which makes tools to help detect coronary artery disease, the companies announced on Tuesday. Medtronic will pay up to $585 million, with the potential for undisclosed earn-out payments after the acquisition closes.
    • “The companies have worked together since 2022, when Medtronic agreed to co-promote CathWorks’ FFRangio System in the U.S., Europe and Japan.
    • “The FFRangio System uses artificial intelligence and computational science to provide an assessment of the entire coronary tree using routine angiograms, a type of X-ray for imaging blood vessels. The system can provide fractional flow reserve, or FFR, values that help detect what lesions are causing a reduction in blood flow. The system can also help physicians measure the dimensions of a lesion during an operation.”
  • Per Radiology Business,
    • “RadNet Inc. is entering the Midwest by acquiring a 60-year-old private practice’s outpatient imaging assets. 
    • “The Los Angeles company has reached a deal to acquire six freestanding centers, all operated by Indianapolis-based Northwest Radiology, for an undisclosed sum. 
    • “Founded in 1967, NWR is one of Indiana’s largest independent imaging groups, employing 18 physicians. They will continue to provide contracted services across the practice’s former locations. 
    • “The centers are primarily located in Carmel, a growing northern suburb of Indianapolis recently recognized by Travel & Leisure magazine for its livability. RadNet—which, as a publicly traded company, will eventually disclose the purchase price in a future regulatory filing—expects to net $18 million in annual revenue from the sale. 
    • “Steve Forthuber, president and CEO of Eastern Operations for RadNet, said the practice has built “remarkable trust and confidence” among the local physician community. The company plans to work closely with NWR radiologists to further expand their “clinical reach and capabilities.” 

Weekend update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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