From Washington, DC,

• The American Hospital Association (AHA) News tells us,
  • “The Department of Justice March 27 announced it is launching an Anticompetitive Regulations Task Force to advocate for “the elimination of anticompetitive state and federal laws and regulations that undermine free market competition.” The DOJ said its Antitrust Division is seeking public comments until May 26 on laws and regulations considered to be the most significant barriers to competition in markets such as health care, housing, transportation, food and agriculture, and energy.”

From the judicial front,

• STAT News lets us know,
  • “A federal judge in Texas squashed the Food and Drug Administration’s plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds. 
  • “The Court VACATES and SETS ASIDE, in its entirety, the FDA’s Final Rule titled Medical Devices; Laboratory Developed Tests,” the ruling reads. “The Court remands this matter to the Secretary of Health and Human Services for further consideration.” * * *
  • “Laboratory scientists develop all kinds of tests, including ones looking for rare diseases or cancer, or examining prenatal genetics. Labs argue that their tests are not medical devices, but rather “professional health care services” that should not be subject to regulation. 
  • “Before President Trump took office, experts speculated that his administration might try to roll back the rule anyway given Trump’s deregulatory bent. But the U.S. Department of Justice attorney assigned to the Texas case robustly defended the LDT rule, indicating that the Trump administration was willing to stand by it. 
  • “The judge’s decision may have implications for FDA’s broader authority when it comes to regulating medical devices. The government may appeal the case to the U.S. Court of Appeals for the Fifth Circuit.” 

• Bloomberg Law tells us,
  • “A federal judge rejected Johnson & Johnson’s third attempt to use bankruptcy to set up a multi-billion-dollar trust fund to pay women who claim they got cancer using baby powder and other products allegedly tainted with a toxic substance.
  • “The decision ends the controversial proposal which would have forced a settlement of almost all its talc-related cancer lawsuits. US Bankruptcy Judge Christopher Lopez dismissed the bankruptcy of a small J&J unit called Red River Talc following a two-week trial in Houston in which holdout cancer victims claimed a vote of victims was flawed.
  • “Lopez agreed and dismissed the case.
  • “The bankruptcy case is Red River Talc LLC , Bankr. S.D. Tex., No. 24-90505, 3/31/25.”

From the patient protection front,

• Per the AHA News,
  • “The Food and Drug Administration has identified a Class I recall of Medtronic Aortic Root Cannulas due to a risk of unexpected loose material in the male luer used in the cannula. The loose material could become dislodged and cause serious injuries or death. The FDA said there have been no reports of injuries or death from the issue.”

• Per MedTech Dive,
  • “Bausch + Lomb has recalled intraocular lenses in response to a growing number of reports that some patients are experiencing inflammatory reactions in their eyes, the company said Thursday.
  • “The company has seen a rise in reports of toxic anterior segment syndrome in recipients of its Envista Envy IOLs in the past few weeks, according to a letter to customers. In recent days, Bausch + Lomb received reports of TASS linked to Envista Aspire and Envista monofocal lenses.
  • “Bausch + Lomb is recalling all Envy and Aspire IOLs and certain lots of Envista monofocal lenses. J.P. Morgan analysts estimated 1% of total company sales could be at risk, but their counterparts at Evercore ISI outlined a scenario in which the issue could be resolved in the next six months.”

From the public health and medical research front,

• The American Medical Association tells us ten things doctors wish women know about managing their health.

• STAT News relates “Down to their heart cells, women and men have cardiovascular differences that matter. Men and women’s heart cells even prefer different kinds of fuel, new research shows.”
  • “Heart disease has long been the leading killer of adults, but beyond that stark fact, men and women diverge.
  • “From differences at the cellular level of the heart to circulatory structure to symptoms of distress and treatment, researchers are finding new manifestations of gender differences in cardiovascular disease. 
  • “Heart attacks look different in women than in stereotypically chest-clutching men, sending more diffuse pain shooting through the jaw, neck, arm, back, stomach, and more, all in ways that don’t scream “call 911.” Even where in the body a heart attack blocks blood flow is different: Microvessels in women get jammed, but it’s the larger arteries in men that starve the heart of oxygen. 
  • “The number and function of muscle cells in the heart differ, too. Women’s hearts have more cardiomyocytes than men, and their fuel tends to be more fatty acids as opposed to the sugars that male muscle cells prefer to burn, new research reveals. 
  • “All these differences have implications for diagnosis and treatment of cardiovascular disease.”

• The AHA News informs us,
  • “A study published March 31 by the National Institutes of Health found that adults living in rural areas have worse cardiovascular health than those in urban communities due to social factors such as income, education, having enough food and owning a home. The agency found that those living in rural rather than urban areas were more likely to have heart disease (7% vs. 4%), high blood pressure (37% vs. 31%), high cholesterol (29% vs. 27%), obesity (41% vs. 30%) and diabetes (11% vs. 10%).”
    
• The Wall Street Journal considers “If Vaccines Don’t Cause Autism, What Does? .”The risk of autism develops before we are even born.”
  • “Part of the frustration with autism risk is there isn’t much we can do to control it. Staying healthy during pregnancy, however, can help minimize risk.
  • “Janine LaSalle, a professor of microbiology and immunity at University of California, Davis, says there is evidence suggesting that maternal health risks—such as obesity, weight gained during pregnancy and gestational diabetes—can increase the risk of having a child with autism. 
  • “Another protective action pregnant moms can consider is taking a prenatal vitamin with folic acid and iron supplementation. This is especially important in the first month of pregnancy and so should be started when a woman is trying to conceive, says LaSalle. 
  • “If there was a single smoking gun it would have been found by now,” says LaSalle. “It really is the complexity of the formation of the human brain, and there’s just so many things that can influence it.”

• MedPage Today notes,
  • “A patient navigation program significantly increased follow-up colonoscopy among those with an abnormal fecal immunochemical test (FIT) result.
  • “Ninety-four percent of patients who received navigation completed colonoscopy at 1 year versus 14% of those who received usual care.
  • “The trial was conducted at a community health center, suggesting results are applicable to real-world clinical settings.”

• Beckers Clinical Leadership reflects on “Bariatric surgery’s next act: What 3 leaders expect.”

• Per Beckers Hospital Review,
  • “Novo Nordisk’s diabetes pill Rybelsus, an oral semaglutide, reduced the risk of major heart-related events by 14% in adults with Type 2 diabetes and cardiovascular disease or chronic kidney disease, according to results from a stage 3 trial. 
  • “The findings, presented at the American College of Cardiology’s Annual Scientific Session in Chicago and published March 29 in the New England Journal of Medicine, showed that patients taking Rybelsus had a lower incidence of heart attacks, strokes and cardiovascular deaths compared to those taking the placebo. 
  • “Novo Nordisk has applied for regulatory approval to expand the Rybelsus label to include cardiovascular risk reduction, according to a March 29 news release from the company. The FDA and European Medicines Agency are reviewing the application with a decision anticipated in 2025.”

From the U.S. healthcare business front,

• Modern Healthcare reports,
  • “Patient preferences for where to seek care have shifted in the post-pandemic era.
  • “The use of retail clinics and urgent care centers declined from 2022 to 2023, while emergency department use increased. Telehealth use also declined in that period, though it was still well above levels prior to the COVID-19 pandemic, according to a report from FAIR Health, a healthcare data company.
  • “To see where patients are going, FAIR Health analyzed its database of more than 50 billion claims records, which are provided by payers and administrators that handle claims for commercial plans. The report bases “use” on percentages of total medical claim lines, or the individual procedures listed on claims.
  • “FAIR Health Chief Operating Officer Thomas Swift said care sites are trying to find a new normal, and some of the changes in preferences may be part of the readjustment period.”
    • Retail clinic use is down.
    • Urgent care use also is down.
    • Emergency rooms are seeing growing demand.
    • Urgent care, medical offices have the highest prices.
    • Telehealth demand remains above pre-pandemic levels.

• The Harvard Gazette adds,
  • “A new paper, published in JAMA Network Open, finds a surprising number of Americans traveling out-of-state for cancer care.
  • “The study, co-authored by Center for Geographic Analysis research associate Lingbo Liu, focuses on older adults whose treatment is covered by traditional Medicare, with the most striking results concerning rural Americans. Rural cancer patients in the study’s sample were about twice as likely as city-dwellers to cross state lines for surgical treatments. Rural residents were also three times more likely to leave the state for radiation and four times more likely for chemotherapy.
  • “These findings have important implications for healthcare fragmentation, or receiving services at more than one institution. Fragmentation, which is common with cancer care, is associated with communication gaps and decreased patient satisfaction. But telehealth has the potential to ease these concerns.
  • “When telehealth is used,” Liu offered, “it’s most likely to improve cancer care equity in rural areas and for the diverse populations within those areas.” 

• Modern Healthcare tells us about microhospitals.
  • “What is a microhospital?
    • “A microhospital is a fully licensed, small-scale hospital that operates 24/7 and typically houses eight to 15 inpatient beds, in addition to emergency bays. There is no standard size for microhospitals, but they tend to be less than 50,000 square feet.
  • “What types of services do microhospitals provide?
    • “Microhospitals, also called neighborhood hospitals, can provide acute care, emergency services, surgeries, imaging and lab work to treat less complex conditions, such as broken bones or heart attacks. Higher-acuity trauma patients would be sent to a larger facility.
    • “Services at microhospitals fall between urgent care or ambulatory surgery centers and full-size traditional hospitals, said Joe Kight, head of healthcare for U.S. Bank’s institutional client group. The facilities are generally reimbursed for services at the same rate as a regular hospital.
  • “Who is investing in microhospitals?
    • “Many health systems, including Baylor Scott & White, Intermountain Health and CommonSpirit Health, have invested in microhospitals.”

• Per a press release,
  • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of suzetrigine (Journavx™, Vertex Pharmaceuticals) for the treatment of acute pain.”
  • “ICER’s report on this therapy was the subject of the February 2025 public meeting of the Midwest CEPAC, one of ICER’s three independent evidence appraisal committees. 
  • Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • “It has been a long time since we have had a new class of drugs for acute pain,” said ICER’s Chief Medical Officer David Rind, MD. “Suzetrigine has a different mechanism of action from prior oral therapies, and this creates options for treatment alone or in combination with existing medications. The overall value of this new drug is linked to the risk of a one-week course of opioids leading to opioid use disorder. If the risk is not zero and suzetrigine proves to be safe, we believe that suzetrigine will likely be a cost-effective, and perhaps a cost-saving, alternative from a long-term perspective. However, we note the skepticism about the evidence base from members of the Midwest CEPAC. Longer term data will help define the appropriate role of suzetrigine in practice, but a pain medicine with a new mechanism of action will create options for patients and clinicians.”

• Per Fierce Pharma,
  • “Cigna’s Evernorth unit is expanding coverage for Neuronetics’ therapy for depression to adolescents.
  • “Neuronetics announced that Evernorth will offer coverage for its NeuroStar Transcranial Magnetic Stimulation (TMS) therapy to patients aged 15 and older who have major depressive disorder. The treatment uses magnetic pulses on different parts of the brain, offering an option for severe depression that does not have the same side effects as medication-based therapies.
  • “Per its website, more than 195,000 people have been treated with NeuroStar TMS, with 83% seeing significant improvement in their depression and 62% reporting full readmission.”

• Beckers Hospital Review points out,
  • “Cigna’s Express Scripts has emerged as the largest pharmacy benefit manager in the U.S. by market share, overtaking long-time leader CVS Caremark, according to a March 31 report from the Drug Channels Institute.
  • “In 2024, Express Scripts handled 30% of all prescription claims, up significantly from 23% in 2023. Meanwhile, CVS Health’s CVS Caremark saw its share decline from 34% to 27% over the same period. Express Scripts’ growth was largely driven by a major contract win to manage pharmacy benefits for 20 million Centene members, previously served by CVS Caremark.
  • “Together with UnitedHealth Group’s Optum Rx, which processed 23% of claims, the three largest PBMs accounted for 80% of the total U.S. prescription claims market in 2024 — a one percentage point increase from 2023.”