Weekend update

COVID-19

Weekend update

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Both the Senate and the House of Representatives are on State/District work breaks this week.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services has begun collecting private payor rate data through its Fee-for-Service Data Collection System Clinical Lab Fee Schedule Module. CMS has created a guide for hospital outreach laboratories to determine their applicable status. An FAQ on Protecting Access to Medicare Act reporting is also available, as well as a booklet on reporting scenarios and examples. Next, applicable laboratories must complete the registration process to access the module. Laboratories must then gather their data and complete submission by July 31.”
  • and
    • “The Centers for Medicare & Medicaid Services has opened registration for its seventh annual CMS & Health Level Seven International Fast Healthcare Interoperability Resources Connectathon from July 14-16. The free virtual event will involve health care interoperability leaders, implementers and innovators collaborating for hands-on testing and shared learning on how CMS policies and FHIR-based solutions are being operationalized in real-world systems. Registration will be open through June 30.”

From the Food and Drug Administration front,

  • The Hill reports,
    • Thousands of tins of infant formula have been recalled over a toxin that could lead to illness among babies who consume it, according to a notice posted by the U.S. Food and Drug Administration.
    • In the notice, shared Saturday [May 2], the FDA said a2 Milk Company of Colorado had issued a voluntary recall of three batches of its a2 Platinum Premium USA formula, advertised for children who are 12 months old and younger.
    • “Cereulide, a toxin created by some strains of the Bacillus cereus bacterium, was found to be present in the formula, the notice warns. The toxin, which is not eliminated even when the formula is prepared with hot water, can make infants sick within as little as 30 minutes.”
  • BioPharma Dive relates,
    • “The Food and Drug Administration on Friday approved a particular kind of protein-degrading medicine for the first time, green-lighting biotechnology firm Arvinas’ Veppanu for use in treating certain people with a common form of breast cancer.
    • “Formerly known as vepdegestrant, Veppanu is approved for a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one endocrine therapy. The clearance makes the treatment available specifically to people who fit that criteria and have mutations to a gene called ESR1.
    • “Veppanu is what’s called a “PROTAC,” or proteolysis-targeting chimera. The drug works by taking unwanted proteins — in Veppanu’s case, estrogen receptors — that are linked to disease and trashing them via the cell’s natural waste disposal system. Most approved medicines, by contrast, bind to a molecular target and block or amplify its activity.
    • “This milestone demonstrates that targeted protein degradation can translate into meaningful clinical impact,” said Arvinas CEO Randy Teel, in a statement.” 
  • The Wall Street Journal adds,
    • “British pharmaceutical group AstraZeneca AZN said it would continue to work with U.S. regulators on a review of its breast-cancer candidate after the drug failed to get backing at a key advisory committee vote.
    • “The Food and Drug Administration’s oncologic drugs advisory committee voted six to three against the benefit-risk profile of camizestrant, a candidate drug for the treatment of breast cancer, the FTSE 100-listed drugmaker said late Thursday [April 30].
    • “AstraZeneca will continue to work with the FDA as it completes its review of the application,” it said. The regulator isn’t bound by the committee’s guidance, but takes its advice into consideration.
    • “We strongly believe in the results of the Serena-6 trial [testing camizestrant], and are encouraged that the committee saw camizestrant as a safe and effective potential new medicine,” Astra’s Susan Galbraith said.”
  • Per Fierce Pharma tells us,
    • “AstraZeneca fared better during the second vote at its meeting with the FDA’s Oncologic Drugs Advisory Committee (ODAC) this week. 
    • “On Thursday [April 30], the panel of outside experts voted 7 to 1, with one abstention, in favor of AZ’s bid to propel a regimen of Truqap plus abiraterone (J&J’s Zytiga) and androgen deprivation therapy (ADT) toward approval in PTEN-deficient metastatic hormone-sensitive prostate cancer. 
    • “The committee was swayed on the regimen’s risk and benefit in part by data from AZ’s phase 3 CAPItello-281 trial, in which the Truqap combo helped slash the risk of radiographic disease progression or death by 19% and reached a 7.5-month improvement in median radiographic progression-free survival over a control of Zytiga and ADT.”
  • Per an FDA news release,
    • “Today [May 1], the U.S. Food and Drug Administration is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib. 
    • “The expanded access treatment protocol is for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA received the expanded access request from Revolution Medicines on April 28 and signed it on April 30.” * * *
    • “Granting the request two days after receiving the expanded access application reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Having taken care of many patients with metastatic cancer, I am hopeful that today’s action will improve the lives of patients suffering from this disease.”
    • “Daraxonrasib is a RAS inhibitor designed to inhibit a protein (RAS) that is mutated in most pancreatic cancer tumors.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced on May 1:
    • “As of May 1, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue into May for some regions.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity continues to decrease. Influenza A activity is low across all regions and influenza B activity continues to trend downward.”
  • The University of Minnesota’s CIDRAP adds,
    • Utah this week added 18 more measles cases to its 2026 tally, for a total of 428, while Arizona posted two new cases in its ongoing outbreak, for 93 so far this year, according to their respective state health departments. The outbreak in Utah is currently the largest in the nation.
    • “The nationwide measles infection total for the year to date stands at 1,814, up from 1,792 last week, the Centers for Disease Control and Prevention said today in its weekly update.
    • “Of the national total, 1,803 measles cases were reported by 37 states and New York City. The remaining 11 were diagnosed in international visitors to the United States. Since the beginning of the year, 24 new outbreaks have been noted, and 93% of cases are outbreak-associated (415 from outbreaks starting this year and 1,273 from those that began in 2025). In all of last year, 2,288 measles cases were confirmed. 
    • “This year, 51% of measles infections have occurred in children and adolescents aged 5 to 19 years, and 21% were diagnosed in those younger than 5 years. Among all patients, 92% were unvaccinated or had an unknown vaccination status, while 4% had received only one dose.”
  • The Wall Street Journal reports.
    • “We’ve built a world that can numb discomfort instantly, and we’re surprised we feel less alive. 
    • As artificial intelligence makes life frictionless, we risk removing the very frictions that keep human beings healthy: effort, challenge, learning and forward motion. The next public-health crisis may be stagnation, not stress. 
    • “The fix isn’t another pleasure. It’s progression.
    • “Progression is not simply about moving forward; nor is it about constant achievement or relentless productivity. It is about adaptation: the way a muscle grows stronger when challenged, or a mind becomes more flexible when it explores. 
    • “Progression is engaging in challenges that expand our future capacity—physically, behaviorally and mentally. When we do this consistently, as research conducted in my own labs (as well as many others) shows, we improve mood, strengthen resilience, enhance health and slow many processes associated with aging. 
    • “Humans thrive when they grow. This matters biologically.”
  • The Washington Post relates,
    • ‘For decades, a mysterious, two-lobed organ nestled behind the breastbone has been overlooked by most physicians, thought to be a largely useless lump for most of human life: the thymus.
    • “The ancient Greeks posited this knob of tissue might be the seat of the soul. In the early 1960s, a Nobel laureate dismissed it as a mere graveyard for cells, “an evolutionary accident of no very great significance.” Today, scientists know the thymus plays an essential role in setting up a functioning immune system in childhood, but then starts to rapidly shrink into obsolescence in puberty.
    • “Now, a raft of research is recasting the thymus from a bit player to a potent regulator of aging and immune health across the lifespan.
    • “Studies highlight the crucial role it might play in longevity, as well as protecting against cancer, autoimmune disease and cardiovascular risk. The work has ignited interest in finding ways to rejuvenate the thymus, slow its decay and better understand its function.
    • “It was completely assumed the thymus would become irrelevant,” said Hugo Aerts, director of the Artificial Intelligence in Medicine Program at Mass General Brigham. In studies published in Nature, Aerts and colleagues found that people with a healthier thymus were less likely to develop lung cancer or to die of heart disease — or any cause. They also responded better to cancer immunotherapy treatments.
    • “Key questions remain: Is the thymus the driver of these improved health outcomes or an indirect barometer of better overall health? Why does its decline vary between different people, and can that be slowed or stopped? And, perhaps most fundamentally, why did it take so long to reconsider the thymus?”
  • The New York Times points out “three medical routines that older people may not need>
    • “Some screenings and treatments no longer make sense for patients as they age. Researchers have just added a few more to the list.”
  • MedPage Today notes,
    • “Infection remains a top cause of maternal mortality with most infection-related maternal deaths being preventable, a descriptive study of Maternal Mortality Review Committee (MMRC) data found.
    • “Only half of moms who died from infection-related causes within 1 year of the end of pregnancy (51.5%) had confirmed receipt of antibiotics and only 11.8% had received antibiotics within the recommended 1 hour, reported Naima T. Joseph, MD, MPH, of Boston Medical Center and Boston University School of Medicine, in a presentation at the American College of Obstetricians and Gynecologistsopens in a new tab or window (ACOG) annual meeting.” * * *
    • “ACOG attendee Sophia Drosinos, MD, of Viva Eve in New York City, told MedPage Today that the findings were “gut wrenching.”
    • “Drosinos, who was not involved in the research, noted that “most hospitals now have some sort of sepsis protocols very early on in somebody’s presentation,” but that she hoped hopefully hospitals will include all of the strategies outlined in the study to decrease maternal mortality.”
  • Per a National Institutes of Health news release,
    • “A team of National Institutes of Health (NIH) scientists and international colleagues have reported the first evidence from a randomized controlled clinical trial indicating that a GLP-1 receptor agonist can reduce the days in which patients with obesity and alcohol use disorder engage in heavy drinking. Led by researchers at Copenhagen University Hospital, the new study adds to a growing body of evidence suggesting that GLP-1s could be useful in treating alcohol use disorder.
    • “Very few medications are currently approved for alcohol use disorder, and these are vastly underutilized. A new option that is more accessible and more effective could be a gamechanger for closing the treatment gap,” said Director of NIH’s National Institute on Alcohol Abuse and Alcoholism (NIAAA) George Koob, Ph.D., a study co-author.”
  • Medscape significantly adds,
    • “GLP-1 medications may cause slight muscle loss, but benefits outweigh concerns. Weight loss, whether through GLP-1s or lifestyle changes, can reduce muscle mass. Resistance training and adequate protein intake are recommended to mitigate muscle loss.”
  • Health Day lets us know,
    • “Higher intake of legumes and soy products is associated with fewer chronic obstructive pulmonary disease (COPD) symptoms among former smokers, according to a study published online Feb. 23 in Chronic Obstructive Pulmonary Diseases.”

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

  • The Wall Street Journal reports,
    • Eli Lilly LLY Chief Executive Dave Ricks was on stage with Nvidia NVDA founder Jensen Huang earlier this year in San Francisco touting the company’s tech prowess when Huang teased him about the painstaking process of developing new drugs.” 
    • “I’m really hoping that your industry moves from drug discovery which is kind of like wandering around the forest looking for truffles,” Huang said, in front of a crowd of biotech and pharma investors.
    • “Indeed, Ricks and the rest of the pharmaceutical industry are looking to expand beyond collecting soil samples and bark pieces to find new drugs and are instead turning their hopes—and investment dollars—to AI. Lilly first announced a partnership with chip-maker Nvidia in October to build what it called the industry’s most powerful supercomputer, and expanded that in January with a $1 billion, five-year collaboration mixing their scientists and engineers in a new Bay Area lab aimed at discovering new medicines with AI tools.
    • “They aren’t alone. Rival Roche has already announced it is building an even bigger supercomputer in partnership with Nvidia. Companies such as GSK, AstraZeneca and Merck have announced billions of dollars worth of partnerships in recent months with tech and AI-focused biotech companies aimed at fully exploiting AI.
  • BioPharma Dive relates,
    • “Moderna topped Wall Street analysts’ expectations in reporting higher-than-expected revenue in the first quarter, adding to an ongoing turnaround that’s helped the company nearly double its market value since late last year.  
    • “The vaccine maker reported first-quarter sales of $389 million, more than tripling its total during the same period a year ago — a surge primarily fueled by international sales of its COVID-19 vaccine. The company did, however, report a net loss of $1.3 billion, about $1 billion more than a year ago, due to charges related to a litigation settlement with Arbutus Biopharma and Genevant Sciences.”
  • Fierce Pharma tells us,
    • “Shortly after laying out $75 million upfront for Corstasis Therapeutics and its congestive heart failure edema drug Enbumyst, Esperion Therapeutics is itself being acquired and taken private by healthcare investment firm Archimed. 
    • “On Friday, the companies announced that Archimed will pay $3.16 per share for Esperion at closing on May 1, alongside a potential CVR sweetener of contingent milestone payments tied to the future sales performance of Esperion’s Nexletol, Nexlizet and Enbumyst that could reach up to $100 million. 
    • “All told, the deal could be worth up to $1.1 billion, assuming those commercial milestones are met, the companies said in a release. The upfront consideration from Archimed marks a 58% premium on Esperion’s closing share price on April 30.” 
  • Fierce Healthcare informs us,
    • “Omada Health has signed on with Optum Rx to participate in its Weight Engage program, furthering the company’s ability to scale its offerings to reach more people who need cardiometabolic care and support.
    • “The pharmacy benefit management giant—which is one of the industry’s Big Three firms—launched the program in response to the demand for GLP-1s, as patients seeking these drugs face spotty coverage and often a thicket of barriers in the way.
    • “Optum said in a post that adherence can also be a challenge, as some patients may face uncomfortable side effects, or may be unresponsive to the medications. That makes having a more holistic, wrap-around model in place to support their journey crucial, the PBM said.
    • “That’s where Omada comes in. Optum is also working with Calibrate and Virta Health under the program, per the announcement.”
  • Medscape notes,
    • “The rapid rise of GLP-1 medications, coupled with declining rates of bariatric surgery, is causing a notable shift in obesity care. Rather than shuttering, however, bariatric surgery practices are choosing to reshape and expand their offerings. 
    • “Private practices and hospital-based bariatric centers alike are broadening their offerings to include not only surgery but also GLP-1 therapies and other medical treatments, along with psychological support, nutrition services, and, in some cases, body contouring procedures to address post-weight loss concerns.
    • “The goal, those involved said, is to create a one-stop center for obesity care, reflecting a growing, research-driven understanding that optimal management does not pit surgical against medical treatments but often requires both to address a lifelong chronic disease.”
  • Beckers Hospital Reviews seeks to share Mark Cuban’s playbook with readers.

Notable Death

  • Genetic Engineering and Biotechnology News reports,
    • “J. Craig Venter, PhD, the founder, board chair, and CEO of the J. Craig Venter Institute (JCVI) has died in San Diego following a brief hospitalization for unexpected side effects that arose from the treatment of a recently diagnosed cancer, reported the JCVI in a press statement.
    • “Venter helped define modern genomics and launch the field of synthetic biology. He was skillful in building interdisciplinary teams, pushing for new ideas and faster methods, and insisting that discovery should translate into real-world impact. He was also a major advocate for strong federal science funding and for partnerships that accelerate progress across government, academia, and industry.”
    • “Craig believed that science moves forward when people are willing to think differently, move decisively, and build what doesn’t yet exist,” said Anders Dale, PhD, president of JCVI. “His leadership and vision reshaped genomics and helped ignite synthetic biology. We will honor his legacy by continuing the mission he built—advancing genomic science, championing the public investments that make discovery possible, and partnering broadly to turn knowledge into impact.”
    • “Venter has been recognized as an essential force in the impetus to evolve genomics from a slow, academic discipline into a fast-moving, data-driven, and commercially relevant enterprise, leaving a lasting imprint on biotechnology, medicine, and synthetic biology,” says John Sterling, GEN’s Editor in Chief, who has known and worked editorially with Venter over the past 35 years.
    • “Venter was controversial and often challenged the scientific orthodoxy, with critics accusing him of hype and going overboard on privatization. To many, he was a visionary focusing on technological acceleration and blending academic science with the zeal of an entrepreneur. Supporters saw him as a pioneer who sped up genomics by years.”
  • Mr. Ventner was 79 years old at the time of his death. RIP.

Monday report

David Ermer–CDC, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Beckers Hospital Review reports,
    • “Americans spend more than $1.6 trillion a year on hospital care — roughly one-third of all health spending — and a new paper from the nonprofit think tank Paragon Health Institute argues that government policy is the primary driver of why those costs keep climbing.
    • “The paper, “The Hospital Cost Crisis: How Government Policies Drive Consolidation, Undermine Competition, and Fuel Soaring Prices,” was authored by John Graham, a visiting fellow at Paragon with nearly three decades of health policy experience.” * * *
    • Click here to read the paper in full. FEHBlog note — The article includes ten highlights from the report.
  • and
    • “Johnson & Johnson will begin marketing four prescription drugs on the Trump administration’s TrumpRx website, according to an April 24 report from CBS News.
    • “The drugs include metformin, metformin extended release, Invokana and Xarelto. Pricing on the platform shows Invokana discounted 62% to about $225 from $598.56, Xarelto discounted 68% to about $197 from $611.82, and Invokamet XR — an extended-release combination of canagliflozin and metformin — discounted 62% to about $225 from $598.56, based on listed cash-pay prices.”
  • MedPage Today relates,
    • “Advocates for the LGBTQ+ community claimed a win this week after the Trump administration pledged to reinstate the 988 Suicide and Crisis Lifeline specialized support program tailored to their needs.
    • During a Senate hearing earlier [last] week, HHS Secretary Robert F. Kennedy Jr. was asked whether he would commit to restoring the tailored line for LGBTQ+ callers to 988, as required by law, after the Trump administration removed it last summer.
    • “We are working on getting it up now,” Kennedy said.
    • “While most 988 calls are routed to the nearest call center, callers who press 3 or text PRIDE were once connected to a centralized network of trained crisis counselors who have shared lived experiences or are trained to provide services to LGBTQ+ youth.
    • “Linking callers to local resources is usually best, since support outside of a phone call might be needed. However, for those in states where attacks on LGBTQ+ individuals are widespread, local resources may not be preferred, Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness, told MedPage Today.“
  • The American Hospital Association News tells us,
    • “The AHA again is asking the Health Resources and Services Administration to take action after Eli Lilly warned hospitals that they could lose access to discounted drug prices unless they comply with new data submission requirements.
    • “The AHA said Eli Lilly recently issued a letter to hospitals participating in the 340B Drug Pricing Program threatening the “imminent loss” of discounted pricing if claims data are not submitted “without further delay.”
    • “The AHA for months has raised concerns with HRSA about these practices.
    • “Unfortunately, we are not aware of any action that HRSA has taken to address these unlawful drug company claims-data policies, even as more and more companies have announced policies similar to Lilly’s,” the AHA wrote. “HRSA’s inaction here stands in stark contrast to the speed with which it acted in 2024 when the drug companies announced their unlawful rebate policies.”

From the Food and Drug Administration front,

  • Health Exec reports,
    • “Multiple wound and burn gel products are being removed from where they are used or sold, after it was discovered that a packaging failure was leading to the sterile barrier being breached. Unfortunately, this has led to at least 14 serious injuries. 
    • “The manufacturer of the gels, Integra LifeSciences, issued a letter to distributors of the products,  branded as MediHoney and CVS Wound Gel. The products are sold in retail settings, but also may be found in patient care settings. 
    • “In a statement, the U.S. Food and Drug Administration (FDA) said it’s aware of the issue and provided the known details. The agency said it has determined that using wound gels with the defective packaging may “cause temporary or reversible health problems, or—though unlikely—serious health problems.”
    • “Despite the risk of severe infection and the recorded injuries, there are no known deaths associated with the recalled wound gels.” 
  • The American Hospital Association adds,
    • “The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable Sheath Introducers be taken out of use due to a design defect where the sheath introducer may not split as intended. In addition, the FDA issued an Early Alert for Omnicell i.v.STATION sterile labels. Omnicell recommends customers do not use affected labels. They should verify the accuracy of labels on filled products.”
  • Fierce Pharma tells us,
    • “AstraZeneca’s systemic lupus erythematosus (SLE) med Saphnelo may have earned a considerable convenience edge in the United States, courtesy of an FDA nod clearing the drug for self-administration via a once-weekly autoinjector. 
    • “As with the drug’s original SLE nod in 2021, the self-administration green light covers the use of Saphnelo on top of standard therapy, AZ said in an April 27 release. In its original formulation, Saphnelo, also known as anifrolumab, is given as an intravenous infusion. 
    • “The FDA signed off on the new administration route after reviewing data from the late-stage TULIP-SC study, in which subcutaneous dosing of Saphnelo triggered statistically significant and clinically meaningful disease activity reductions versus placebo, according to AZ.”
  • and
    • “Johnson & Johnson is bolstering the case for its approved schizophrenia med Caplyta to prevent relapses in the disease. 
    • “On Monday, the FDA approved J&J’s supplemental new drug application for the atypical antipsychotic to include long-term data on the med’s schizophrenia relapse-prevention capabilities.
    • “In a press release, J&J clarified that the “label update builds upon the existing clinical data and postmarketing experience across [Caplyta’s] approved uses.” 
    • “Relapses pose a significant challenge for schizophrenia patients and can disrupt stability, undermine functioning and often trigger episodes of psychosis, hallucinations and other symptoms that have the potential to disrupt daily life, according to J&J. On average, adults living with the condition experience nine relapse episodes within a six-year period, the company added.” 

From the public health and medical / Rx research front,

  • NBC News reports
    • “Deaths from rectal cancer are rising rapidly among younger adults, an alarming trend that is confounding scientists trying to understand why millennials are so hard-hit. 
    • “The rate of rectal cancer seems to be increasing more than two to three times compared to colon cancer,” said Mythili Menon Pathiyil, lead author of a new study and a gastroenterology fellow at SUNY Upstate Medical University in Syracuse, New York. 
    • “If the trend continues, rectal cancer deaths will exceed the number of colon cancer deaths — already the nation’s No. 1 cause of cancer death in people under age 50 — by 2035.”
    • “According to the American Cancer Society, 158,850 new colorectal cancers will be diagnosed in 2026. About 55,230 patients will die from the disease, with nearly a third of those deaths in people under age 65. Colon cancer and rectal cancer are similar but form in different parts of the digestive tract. 
    • “The new research, which hasn’t yet been published in a peer-reviewed journal, is scheduled to be presented at Digestive Disease Week, an annual meeting of gastroenterologists, in May. 
    • “The findings, however, strengthen an American Cancer Society study released in March showing that a rise in rectal cancer rates is driving increases in colorectal cancer diagnoses in people younger than age 65. Colorectal cancer rates have been increasing 3% each year for adults under age 50 since the late 1990s and scientists are scrambling to understand why.”
  • STAT News considers what happened to COVID?
    • “There is an ever-shrinking portion of the population that thinks it’s never been infected — the folks who call themselves Novids. Even among that population, many have all but certainly been exposed to the virus but had only asymptomatic infections.”
    • “This, many experts told STAT, explains why the threat from Covid has subsided.” * * *
    • “Most of the experts STAT consulted believe the virus either now qualifies as, or is on its way to becoming, just another one of the viruses that make people sick with cold or flu-like symptoms — with some caveats. For one, the risk remains high for some people — particularly older people, very young children, and people with medical conditions that weaken their immune systems. For another, cold and flu-like viruses trigger symptoms that range from sniffles and coughs to knock-you-off-your-feet illness. A bad case of flu can take a couple of weeks to recover from, even for a healthy person. Same with Covid.” * * *
    • “Marion Koopmans, scientific director of the Pandemic and Disaster Preparedness Center at Erasmus University in Rotterdam, the Netherlands, said at this point, annual boosting is probably not doing much for people who aren’t at high risk.
    • “What we really would need is data on what the effect is of boosting on variant specific responses AND protection from disease over increasing intervals between boosters. That data is virtually impossible to get,” she wrote in an email. (Pfizer recently announced it had halted a clinical trial the Food and Drug Administration asked it to conduct in healthy adults aged 50 to 64, because it couldn’t recruit enough volunteers.) 
    • “But for high-risk individuals, Covid boosters still offered protection against becoming sick enough to require hospitalization, the latest study in the Netherlands concluded, Koopmans said.”  
  • MedPage Today adds,
    • “Two multicenter trials [(PANORAMIC and CanTreatCOVID)] found no change in hospitalization and death rates when antiviral nirmatrelvir-ritonavir (Paxlovid) was given to COVID-19 patients already mostly vaccinated.” * * *
    • “Now, the PANORAMIC and CanTreatCOVID results reflect a COVID-19 landscape that’s shifted since the pandemic’s early period, said H. Clifford Lane, MD, former deputy director for clinical research and special projects at the National Institute of Allergy and Infectious Diseases (NIAID), and Anthony Fauci, MD, the former NIAID director.
    • “These new data indicate that the 89% relative risk reduction seen in the analysis of hospitalizations or death associated with the use of nirmatrelvir-ritonavir in the EPIC-HR trial does not apply to the current circumstances, in which most adults have varying degrees of preexisting immunity and the circulating variants are different,” Lane and Fauci wrote in an accompanying editorialopens in a new tab or window.
    • “That doesn’t mean nirmatrelvir-ritonavir’s therapeutic time has come and gone, they cautioned. PANORAMIC and CanTreatCOVID participants who took the combination drug saw enhanced recovery and faster viral load reductions, they noted, which points to both clinical efficacy and antiviral activity.”
  • Health Day tells us,
    • “The eyes are the windows not only to the soul, but also to a person’s health, a new study says.
    • Premature aging of the retina could be a red flag for major diseases like diabetes or heart disease, researchers recently reported in the journal Communications Medicine.
    • “They found that people had a higher risk of chronic disease if they had advanced aging of their retinas — the light-sensitive layer of cells that lines the back wall of the eye.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded clinical study shows that a symptom-based treatment for babies with neonatal opioid withdrawal syndrome (NOWS) — a highly prevalent condition wherein opioid exposure during pregnancy leads to withdrawal after birth — could speed up their recovery.
    • “To treat babies with moderate to severe symptoms of NOWS, doctors often administer opioid medication, lowering the dose over time. Many doctors commonly use this scheduled dosing approach, however, the new study found that providing “as-needed” doses of opioid medications based on each baby’s signs of withdrawal helped them stop the medicine sooner and go home earlier.
    • “Scheduled opioid dosing, which includes a taper, is necessary for some infants with NOWS, however it may overtreat others,” said corresponding author Lori Devlin, D.O., a professor of pediatrics at the University of Louisville and Norton Children’s Neonatology. “The idea is that by matching treatment to disease severity, we can accelerate recovery and minimize exposure.”
  • Genetic Engineering and Biotechnology News informs us,
    • “A cellular-resolution molecular map details how Down syndrome alters human brain development before birth. The study analyzed more than 100,000 nuclei from human prenatal neocortex samples collected across 26 pre-genotyped donors during gestational weeks 13 to 23—the only window during which all the cortical neurons a person will carry for their entire life are generated. The findings suggest that Down syndrome disrupts the developmental sequence of that process, creating shifts that may help explain later differences in cognition, learning, and sensory processing.
    • “This work is published in Science in the paper, “A single-cell multiomic analysis identifies molecular and gene-regulatory mechanisms dysregulated in developing Down syndrome neocortex.“
    • “There’s a new level of detail here that had never existed before,” said Luis de la Torre-Ubieta, PhD, an assistant professor of psychiatry and biobehavioral sciences at UCLA and a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research. “For the first time, we can really try to understand systematically what’s going on in the developing brain of individuals with Down syndrome.”
  • STAT News points out,
    • “The drugmaker Erasca said Monday that its RAS-targeting pill shrank tumors in 40% of patients with advanced pancreatic cancer and 62% of patients with advanced non-small cell lung cancer, results that the company said exceeded its expectations. 
    • “The new data, collected from studies done in the U.S. and China, are still preliminary. However, Erasca said the clinical benefit and tolerability of its drug, called ERAS-0015, compared favorably to daraxonrasib, a similar RAS-targeting drug from Revolution Medicines that recently showed a doubling of overall survival in patients with advanced pancreatic cancer.
    • “I’m excited about both datasets, but I think lung is more definitive at this point. The pancreatic results are maturing, but are very, very promising,” Erasca CEO Jonathan Lim told STAT. “All options are on the table.” 
  • and
    • “An oral medicine for hair loss successfully spurred hair growth in a late-stage trial, startup Veradermics announced Monday.
    • “Veradermics assessed the pill in two ways: by how many hairs grew within a square centimeter of the scalp, on average, and by how satisfied participants were with the results. Over the course of six months, men who took the drug, known as VDPHL01, either once or twice daily had between 30 and 33 more hairs per square centimeter of scalp. Men in the placebo group grew approximately seven additional hairs.
    • “Between 79% and 86% of men taking VDPHL01 said they saw improvement, along with between 72% and 84% of the clinical trial investigators — results that pleased Reid Waldman, a dermatologist turned Veradermics’ chief executive.” 
  • BioPharma Dive adds,
    • “An experimental gene editing medicine from Intellia Therapeutics has succeeded in a Phase 3 trial, positioning the company to seek approval of what would be the first treatment of its kind for a rare disorder known as hereditary angioedema.
    • “When compared to a placebo, the therapy, “lonvo-z,” reduced the rate of the disease’s hallmark swelling attacks by 87% over the course of about six months, meeting the study’s primary objective. Lonvo-z also helped rid 62% of recipients of disease attacks or the need for other therapies during that follow-up period, versus 11% of placebo patients.
    • “Intellia said, without specifics, that lonvo-z had a “favorable” safety and tolerability profile. The most common treatment-emergent side effects were infusion-related reactions, headache and fatigue, and all reported by a Feb. 10 data cutoff were mild to moderate in degree. The company has begun a “rolling” U.S. approval submission and, assuming a clearance, intends to launch lonvo-z in the first half of 2027.” 

From the U.S. healthcare and artificial inteliigence front,

  • Beckers Payer Issues reports,
    • “Elevance Health has set aside $935 million to cover potential costs tied to its ongoing risk adjustment data dispute with CMS, which threatens the insurers’ ability to enroll new members into some of its Medicare Advantage plans.
    • “CFO Mark Kaye disclosed the charge during the company’s first quarter earnings call on April 22, saying the figure reflects Elevance’s current best estimate of what the issue could cost as it works toward a resolution with the government.
    • “[Elevance CEO Gail} Boudreaux also characterized the issue as a historical payment dispute rather than a current compliance concern.”
  • and
    • “CenterWell, Humana’s pharmacy branch, is collaborating with Mark Cuban’s Cost Plus Drug Co. for an employer-based program, according to an April 27 news release.
    • “CenterWell will use Cost Plus Drugs’ SwiftyRx, a digital pharmacy software-as-a-service solution, for medication order intake. The platform should enable CenterWell to offer home delivery pharmacy services for the insurer’s eligible workforce in the Humana Associate Benefit Plan.
    • “Along with SwiftyRx, the organizations will harness Cost Plus Drugs’ drug pricing and CenterWell’s distribution strategies. The collaboration aims to ease access and reduce patient cost through smoother onboarding, automated benefit checks, lowered costs to fill prescriptions and operational efficiency.” 
  • Healthcare Dive points out,
    • Nearly three-quarters of U.S. finance leaders rank healthcare among their companies’ five biggest operating expense concerns, consulting firm Mercer found in a recent survey.
    • “The research comes as the rapid rise of GLP-1 weight-loss medications — like Wegovy and Ozempic — is adding to volatility in employer health costs.
    • “The survey results make clear the far-reaching impacts of rising health benefit costs for individual organizations,” Susan Potter, president of Mercer U.S. & Canada, said in an emailed statement. “Only about one in four CFOs said that their organization was able to absorb the cost increases over the past two years without any business impacts, such as slower wage growth, reduced hiring, or higher prices.”
  • Fierce Healthcare relates,
    • “Insurers are putting a growing focus on specialty drugs covered under the medical benefit, and on re-evaluating the efficacy of traditional rebate models, according to a new report.
    • “The Pharmaceutical Strategies Group (PSG) on Monday released its annual Trends in Specialty Drug Benefits report, which offers a look at how payers are responding to rising costs for these products and striking a balance between cost management and access.
    • “PSG surveyed 228 benefits leaders representing employers, health plans and union coverage, and found that 43% ranked managing specialty drug costs as their top goal. By comparison, 37% said their No. 1 goal is to manage total cost of care, per the report.
    • “As more and more of these products come to market and existing drugs gain new indications, managing them across the pharmacy and medical benefits poses significant complexity, the report found. More payers listed this as a top challenge than access to integrated data or member affordability.”
  • The Wall Street Journal reports,
    • “Eli Lilly agreed to acquire Ajax Therapeutics for up to $2.3 billion to bolster its blood-cancer portfolio.
    • “Ajax Therapeutics is developing AJ1-11095, a Type II JAK2 inhibitor for myelofibrosis patients.
    • “Eli Lilly’s deal to buy Ajax adds to a recent spate of pharma acquisitions, including several by Lilly.”
  • and
    • [India’s] Sun Pharmaceutical Industries will acquire U.S.-listed Organon for $11.75 billion, becoming a top three global women’s health player.
    • Organon, a Merck spinoff, has over 70 products in women’s health and general medicines, commercialized across 140 countries.
    • Sun Pharma will fund the all-cash deal through internal cash and bank financing; the acquisition will make it a top seven global biosimilars player.
  • and
    • “Ligand Pharmaceuticals LGND said it has reached a deal to acquire Xoma XOMA Royalty, a company that invests in a range of biotech firms, for around $740 million.
    • “Under the terms, Ligand will pay $39 a share in cash for Xoma, a 2.9% premium over the $37.90 closing price on Friday. The deal is expected to close in the third quarter.
    • “Both Ligand and Xoma are known as royalty aggregators for investing in drugs while they are in development and then, if they work out, collecting royalties from their sales.
    • “By absorbing Xoma, Ligand’s total portfolio would more than double in size to more than 200 drugs and experimental treatments, including a handful of medicines on the market and several in late-stage studies.”
  • MedTech Dive adds,
    • “Johnson & Johnson said Friday it has struck a deal to buy Atraverse Medical, an atrial fibrillation ablation device developer founded by the team behind Farapulse.
    • “Atraverse sells a radiofrequency guidewire used to create an atrial septal defect to treat AFib. The Food and Drug Administration cleared the Hotwire device for use in 2024.
    • “Hotwire competes with products including Boston Scientific’s ProTrack RF Anchor Wire, which Atraverse cited as the predicate product in its 510(k) submission.”
  • Beckers Health IT observes,
    • “For years, the conversation about AI in health systems centered on technology adoption: which tools to buy, which pilots to run, which workflows to automate. But as health systems move from isolated AI deployments toward enterprise-wide agentic platforms, the limiting factor is no longer the technology. It’s the people managing it.
    • “That was the central tension running through a panel of health system technology leaders at Becker’s 16th Annual Meeting in Chicago this spring. Across organizations ranging from a large rural integrated delivery network to an urban academic medical center to a national cancer system, the same challenge surfaced: operations leaders have not yet grasped that they are now managing a digital workforce — and the consequences of that gap are starting to show.
    • “The biggest barrier to us moving forward is really getting operations to understand that this fundamentally changes their role in the equation,” said Jeff Gautney, CIO of Rush University Medical Center in Chicago. “They are managing a digital workforce and they need to think that way as opposed to [thinking that] IT is monitoring this, IT is keeping an eye on it, IT is delivering this solution and I don’t really need to think any differently about it.”
  • MedCity News adds,
    • “There are plenty of AI startups on the market promising to bolster hospitals’ finances by increasing revenue. But that’s not the case for San Francisco-based Midstream Health.
    • “For most health systems, the key to unlocking dollars isn’t boosting revenue — it’s decreasing costs, said Venkat Mocherla, Midstream’s co-founder and president.
    • “Midstream, founded in 2023, uses AI to clean up and unify hospitals’ fragmented financial and operational data, which helps leaders spot savings opportunities and make smarter purchasing decisions, he explained. For instance, the platform could help surface insights that help a hospital capture missed rebates or avoid overpaying for supplies and devices.” * * *
    • T”he company’s platform is being used across health systems including Mount Sinai, CommonSpirit and Houston Methodist. Midstream primarily makes money by taking a cut of the savings it generates, which Mocherla noted aligns the startup’s incentives directly with hospitals’ financial outcomes.”

Noteworthy Death

  • Cardiovascular Business reports,
    • “Pioneer cardiologist Eugene Braunwald, MD, often referred to as the “father of modern cardiology,” died April 22. He was 96 years old.
    • “Braunwald was born in Vienna, Austria, and immigrated to the United States as a child to flee Nazi persecution. He went on to hold leadership positions with the National Heart, Lung and Blood Institute; the University of California, San Diego; Brigham and Women’s Hospital and Harvard Medical School. He authored or co-authored more than 1,000 publications over the course of his career and helped shape medical education for many years as the longtime editor of Harrison’s Principles of Internal Medicine, a premier textbook for clinicians. 
    • “Braunwald was also a lifelong contributor to a variety of industry societies, including the American College of Cardiology (ACC), American Heart Association (AHA) and European Society of Cardiology (ESC). He earned the highest honors from all of these groups over the course of his career in medicine, and the AHA even started giving out the Eugene Braunwald Academic Mentorship Award annually in 1999.”
  • RIP

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, Patient safety, U.S. Healthcare–

From Washington, DC

  • The Thompson Hine law firm tells us,
    • “The Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) recently released their 2025 Report to Congress on enforcement activity under the Mental Health Parity and Addiction Equity Act (“MHPAEA”).” * * *
    • “Both the DOL and the Centers for Medicare & Medicaid Services (CMS) issued more requests for comparative analyses signaling that enforcement was active in the two year period.” * * *
      • “Employers should continue to pay careful attention to the following specific types of NQTLs that continue to draw the most scrutiny from the Departments:
      • “Provider network admission standards,
      • “Prior authorization requirements,
      • “Concurrent care review requirements, and
      • “Exclusions of key mental health and substance use disorder treatments (such as ABA therapy, methadone maintenance treatment, and nutritional counseling for eating disorders).”
  • Healthcare Dive reports,
    • “A pilot program that adds artificial intelligence-backed prior authorization for some services in Medicare is delaying care for seniors in Washington, according to a report released Wednesday by one of the state’s Democrat senators. 
    • “Under the WISeR program, procedures that were previously approved within about two weeks now take four to eight weeks to be authorized, according to survey data from the Washington State Hospital Association.
    • ‘The pilot is creating increased administrative work for providers in the state, as well as potentially worsening health outcomes for patients whose care is delayed, the report released by Sen. Maria Cantwell, D-Wash., found. “It’s not taking a few days to find out whether you’re going to get covered or not,” Cantwell said during a Senate Finance Committee hearing Wednesday. “It’s basically taking weeks to find out you were denied.”
  • KFF News relates,
    • “More than 12 million people — about 43% of those in traditional Medicare [including the FEHBlog] — buy a Medigap policy. Others rely on some sort of retiree employer coverage or a different backup. About 13% of people in traditional Medicare don’t have supplemental coverage, according to KFF, meaning they could be vulnerable to large costs if they have a serious illness.
    • “In the supplemental market, following big increases last year, rates appear to be rising again. In early 2026 filings with state insurance commissioners from Aetna, Blue Cross Blue Shield, Cigna, Humana, Mutual of Omaha, and UnitedHealthcare, rate increases for Plan G policies — the most commonly purchased supplement type — ranged from just over 12% to more than 26% in the first quarter, according to Nebraska-based consulting firm Telos Actuarial.
    • “While this is a small dataset across a select number of states, it’s an indication that carriers are looking to correct their premium rates in light of upward pressure on their claims experience,” said Brett Mushett, a consulting actuary with Telos.”
  • Contemporary OB/GYN lets us know,
    • “The American Medical Association (AMA) and the Current Procedural Terminology (CPT) Editorial Panel have approved a comprehensive restructuring of maternity care services codes, marking a departure from the long-standing global payment model, according to an announcement from the Association. 
    • “Beginning January 1, 2027, the CPT code set will transition to a granular framework that replaces the traditional bundled payment model with codes that accurately represent 4 distinct phases of care: 
      • “Antepartum 
      • “Labor management 
      • “Delivery 
      • “Postpartum.
    • “This transition follows nearly 2 years of collaborative efforts between the AMA, the American College of Obstetricians and Gynecologists (ACOG), and various national medical specialty societies. By moving away from the legacy global model, which historically reported maternity care as a single service, the new structure is designed to reflect the realities of modern, team-based obstetric practice, a change that ACOG is welcoming.” * * *
    • “To facilitate this transition, the AMA is releasing the 2027 codes ahead of the standard schedule to ensure that physicians, payers, and EHR vendors have sufficient time to prepare. ACOG and the AMA have developed several educational resources to support clinicians through this transition as they move toward a framework that supports improved transparency and risk adjustment.¹
    • “You can view and download these codes via the AMA website, here.”
  • The American Hospital Association News informs us,
    • “The AHA April 24 urged the Sequoia Project to delay implementation of the Trusted Exchange Framework and Common Agreement Individual Access Services Exchange Purpose Standard Operating Procedures version 3.0 until key legal and regulatory issues are resolved. The proposed IAS SOP, slated for implementation by August 2027, includes new patient-matching methodologies that bypass or limit provider verification, which the AHA argues could expose hospitals to unauthorized disclosures, data breaches and misidentification errors. 
    • “The AHA emphasized that hospitals and health systems are already legally bound to verify identity, consent and authority before disclosing protected health information, warning that the proposed IAS SOP does not adequately account for these statutory obligations, creating significant compliance and liability risks for covered entities. To address the risks, the AHA recommended delaying the SOP and pursuing statutory or regulatory solutions, such as a provider safe harbor or clear regulatory guidance confirming compliance with IAS satisfies the Health Insurance Portability and Accountability Act verification and consent requirements.” 

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration today announced it is accelerating regulatory action on a new class of psychedelic-based therapies, following an April 18 executive order calling to speed up access to treatments for serious mental illness. The agency said it will prioritize development and review of serotonin-2A agonists for conditions such as treatment-resistant depression, post-traumatic stress disorder and substance use disorders, including issuing national priority vouchers for studies of the drugs psilocybin and methylone for alcohol use disorder. The FDA also noted it would aim to balance urgency with rigorous science and to expect final guidance for study sponsors soon.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19
      • COVID-19 activity is low in most areas of the country.
    • “Influenza
      • Seasonal influenza activity continues to decrease. Influenza A activity is low across all regions and influenza B activity continues to trend downward.
      • Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue through April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • National vaccination coverage for COVID‑19, influenza, and RSV remained low among both adults and children. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • The American Hospital Association News reports,
    • “The Utah measles outbreak has increased to 607 cases, the state’s Department of Health and Human Services reported April 24. Nationwide, there have been 1,792 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 93% of cases are outbreak-associated, and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • The Hill relates,
    • “With spring in full force and summer on the way, the Centers for Disease Control and Prevention (CDC) is raising the alarm on tick bites.
    • “The agency says the bites are sending Americans to the emergency room(ER) at the highest rate in nearly 10 years. 
    • “During the second week of April, 71 out of every 100,000 emergency room visits were for tick bites, according to the CDC.
    • “The administration’s data notes that the Northeast region of the country has seen the largest spike in ER visits, followed by the Midwest.
    • “To avoid potential tick bites, the CDC recommends steering clear of wooded and brushy areas with high grass and leaf litter. They also advise checking animals that go outside every day during warm weather.”
  • The University of Minnesota’s CIDRAP tells us,
    • “Transmission of clade 1 mpox virus during commercial air travel appears to be uncommon, according to a study published yesterday [April 23] in Morbidity and Mortality Weekly Report from the US Centers for Disease Control and Prevention (CDC).” 
  • The American Medical Association lets us know what doctors wish patients knew about cervical cancer prevention.
  • MedPage Today points out,
    • “The epidemiology of sudden cardiac deaths (SCDs) was turned on its head Thursday, with research showing that in reality, ischemic cardiac disease is not the leading driver of SCDs, as previously thought.
    • “From a prospective autopsy study of unselected deaths in San Francisco County, California, it was evident that out of 943 presumed SCDs, 62% were autopsy-confirmed, and only 41% of those were due to myocardial infarction (MI) upon comprehensive postmortem and histologic evaluation — “one-half the long-accepted 80% prevalence among SCDs,” according to Zian Tseng, MD, MAS, of University of California San Francisco, and colleagues of the POST SCD study.
    • “For the remaining 59% of autopsy-confirmed SCDs not traced to an MI, they can be explained by a range of causes including hypertensive heart disease, dilated cardiomyopathy, substance-related cardiomyopathy, and normal heart primary electrical disease. When an MI was involved, nine in ten cases were attributed to acute or healed MI with obstructive coronary artery disease, and one in ten related to acute MI with nonobstructive coronary arteries (MINOCA).
    • “The study was presented at the annual meeting of the Heart Rhythm Society (HRS), held in Chicago this year. A full manuscript was published in the Journal of the American College of Cardiology.”
  • Per a National Institutes of Health news release,
    • “A large clinical trial supported by the National Institutes of Health (NIH) compared two commonly used treatments for pediatric patients treated for septic shock and found no difference in meaningful outcomes. The trial, which enrolled over 9,000 participants across five countries, sought to answer a longstanding question about which intravenous crystalloid fluid type was the superior option for children who were in septic shock, a life-threatening condition triggered by severe infection which requires immediate medical treatment.
    • “For decades, pediatricians have debated which is the best intravenous resuscitation treatment for children with severe infections who have suspected septic shock,” said Rohan Hazra, M.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the study. “This largest-ever clinical trial for children treated for septic shock has immediate clinical application and allows physicians caring for these vulnerable patients to know they can confidently choose either intervention as a standard of care.”
  • Per Medscape,
    • “New drugs approved in 2025 are poised to significantly improve the management of motion sickness, acute pain, urinary tract infections (UTIs), and chronic spontaneous urticaria.
    • “Gerald W. Smetana, MD, a professor emeritus of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, talked about new treatments in a presentation at the American College of Physicians Internal Medicine (ACP-IM) Meeting 2026 in San Francisco.
    • “This is the first time in my 15-year history of giving this new drugs talk that I’ve given all four drugs a thumbs-up, with the potential to change practice,” Smetana said during his presentation.”
  • Per Health Day,
    • “For adults with type 2 diabetes (T2D), a ketogenic diet (KD) reduces the proportion of proinsulin secreted to a greater extent than a low-fat diet (LFD), according to a study published online April 21 in the Journal of the Endocrine Society.” * * *
    • “We showed that three months of a ketogenic diet was able to improve beta-cell function in patients with T2D, and these improvements were associated with changes in the PICP ratio, a biomarker of pancreas stress,” Yurchishin said in a statement. “Other than bariatric surgery or large-volume intentional weight loss, interventions for improving beta-cell function in T2D do not currently exist.”
  • The Wall Street Journal notes,
    • “A health-tech startup, NewDays, developed an AI chatbot named Sunny to help people with dementia practice communication skills.
    • “NewDays’ service combines telehealth visits with bot practice; a study found seven of nine patients showed cognitive improvement.
    • “A clinical trial, on which NewDays’ therapy is based, found participants had higher cognitive scores than the control group.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “U.S. health insurers are accelerating efforts to streamline prior authorization requirements, with UnitedHealthcare, Aetna and Cigna on Friday detailing progress toward industry commitments aimed at reducing administrative burdens and speeding patient access to care.
    • “UnitedHealthcare said more than half of its prior authorization volume will be incorporated into a standardized electronic submission process, with that share expected to exceed 70% by the end of 2026.
    • “Aetna, a unit of CVS Health CVS -1.59%decrease; red down pointing triangle, said it has already standardized 88% of its prior authorization volume. The company also said it is processing 83% of requests in real time, ahead of a 2027 goal set by insurers, and that more than 95% of eligible requests are approved within 24 hours.
    • “Cigna said it expects to standardize electronic prior authorization submission requirements for more than 70% of volume by the end of the year.
    • “All the companies emphasized the use of automation and digital tools to reduce administrative friction for providers. Aetna said it has eliminated more than 1 million provider calls through automation, while UnitedHealthcare highlighted efforts to reduce documentation requirements and limit the need for follow-up information.”
  • Fierce Healthcare relates,
    • “HCA Healthcare executives worked to reassure investors that lower-than-expected patient volumes during the first quarter are in the past and not expected to diminish the company’s full-year growth targets. 
    • “In quarterly numbers released Friday morning and discussed during an earnings call, the executives focused on two curveballs—a sharp end to the flu season and disruptive winter storms—which said were almost entirely offset by unexpected receipt of Medicaid state supplemental payments. 
    • “Specifically, the quarter’s respiratory-related admissions declined 42% year-over-year while respiratory-related emergency room visits were down 32%, translating to a 70 basis point drag for the former and a 140 basis point dip for the latter. In Texas, Tennessee, North Carolina and Virginia, the inclement weather reduced admissions and ER visits by 30 basis points and 50 basis points, respectively. 
    • “The two factors hit volumes across payer categories and resulted in an estimated $180 million hit to HCA’s adjusted EBITDA, they said. 
    • “On the other hand, an expected $80 million net benefit increase to adjusted EBITDA compared to Q1 2025 related to the supplemental payments was, in reality, about $200 million, thanks to program approvals and reinstatements in Georgia and Texas.” 
  • Kaufmann Hall adds,
    • “Kaufman Hall’s latest National Hospital Flash Report underscores persistent cost pressures that continue to strain hospital and health system finances. Calendar year-to-date margins adjusted for corporate allocations declined at the start of the year. Operational shifts—fewer inpatient days, greater reliance on outpatient revenue, and softer, uneven volumes—reflect an ongoing transition in where and how care is delivered.”
  • MedTech Dive tells us,
    • “Edwards Lifesciences increased its full-year financial forecast as sales of its transcatheter aortic replacement valves grew at a faster-than-expected pace in the first quarter.
    • “Edwards CEO Bernard Zovighian said on a Thursday earnings call that the upturn in first-quarter TAVR sales reflects a move away from watchful waiting in clinical practice for patients with severe heart valve disease.
    • “There has been a shift toward proactive disease management with an increased focus on evaluation and intentional referral of patients with severe aortic stenosis earlier in the disease pathway,” Zovighian told analysts and investors.
    • “He said heart patients are being referred for valve replacement sooner due to the company’s study data that points to better outcomes with earlier treatment and the long-term durability of its Sapien valves. It was Edwards’ third consecutive quarter of double-digit TAVR sales growth.”
  • The Wall Street Journal cautions,
    • “After months of dizziness and arms aching so badly, she could barely walk her dog, Susan Glannan lay stunned in a sunny hospital room as a doctor told her she should have open heart surgery. 
    • “The idea of a surgeon cracking her chest open and stopping her heart terrified her. Glannan, who was 64, lived alone. She didn’t have her affairs in order. And just four years earlier, she had had a procedure that she thought would take care of her heart problem—a diseased aortic valve. “I was disappointed and scared,” she said, “and I started worrying, ‘Do I have a will?’” 
    • “That first procedure was called a transcatheter aortic valve replacement, or TAVR. It’s considered one of the biggest innovations in cardiovascular medicine, offering a way to spare patients the physical and emotional trauma of open heart surgery.
    • “TAVR was approved in 2011 for frail, older patients unlikely to withstand surgery—people with no more than a few years left to live. The Food and Drug Administration later approved it for healthier patients at intermediate and low risk of dying from surgery.
    • “Yet there’s limited research on how long the valves might last. And as TAVR has become more widely used among younger and healthier people, some are finding that their valves don’t work as well or last as long as they hoped. The procedure they thought would spare them a complicated surgery leads some to the operating table anyway.”

Monday report

David Ermer–CMS, Congress, COVID-19 vaccine, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Tomorrow at 11 am ET, the House Appropriations Committee will consider its subcommittee’s print of the appropriations bill for financial services and general government, including the Office of Personnel Management for the fiscal year ending September 30, 2027.
  • The subcommittee’s print includes the standard appropriations provisions exempting FEHB and PSHB carriers from full Cost Accounting Standards coverage (Sec. 611) and limiting abortion coverage to cases when carrying the fetus to term would endanger the mother’s life or the pregnancy results from rape or incest (the Hyde amendment, Secs. 613, 614). The bill (Sec. 761) also states “None of the funds made available by this Act, or in any previous appropriation, may be provided for in insurance plans in the Federal Employees Health Benefits program to cover the cost of surgical procedures or puberty blockers or hormone therapy for the purpose of gender affirming care.” The bill no longer includes the contraception mandate that OPM treated as overridden by the ACA’s contraception mandate. 
  • Federal News Network reports,
    • “The Office of Personnel Management and the General Services Administration — the federal government’s human resources office and landlord, respectively — are embarking on plans to move under one roof.
    • “GSA will temporarily relocate to OPM’s headquarters, the Theodore Roosevelt Federal Building, starting in July, while GSA’s 1800 F St. headquarters goes through a renovation.
    • “In December 2028, GSA will move back into its renovated headquarters, along with OPM. Once consolidation is complete, GSA says it will initiate an “accelerated disposal” of OPM’s old headquarters building.” * * *
      “The first Trump administration proposed merging OPM and GSA into a single agency, but ultimately walked away from those plans. In addition to managing a governmentwide real estate portfolio, GSA provides contracting and IT support to other federal agencies.
    • “OPM Director Scott Kupor said there are no talks of a possible merger of the two agencies.”
  • and
    • “House and Senate Democrats are urging the Office of Personnel Management to halt its plans for collecting detailed medical data on potentially millions of enrollees in the government’s health insurance programs.
    • “Citing “significant legal, ethical and security concerns,” two recent letters sent to Trump administration officials identified potential legal violations and the possibility of targeting enrollees across the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs.
    • “The collection of broad, personally identifiable data regarding medical care and treatment raises concerns that OPM could target certain federal employees seeking vital health care services that the administration disagrees with on political grounds,” House Democrats on the Oversight and Government Reform Committee wrote in an April 17 letter, addressed to OPM and the Office of Management and Budget.
    • “This proposal is another step in the stated goal of traumatizing the federal workforce,” Senate Democrats, led by Sens. Adam Schiff (D-Calif.) and Mark Warner (D-Va.), wrote in a separate April 19 letter to OPM Director Scott Kupor. “We are deeply concerned this information will be used in employment actions, including actions related to hiring, suitability determinations, appeals, reductions in force, disability accommodation requests, labor-management relations and performance reviews.”
  • Roll Call adds,
    • “Senate Republicans plan to release their budget resolution and take a procedural vote as early as Tuesday, kicking off the cumbersome process for a reconciliation bill designed to help end the partial shutdown of the Department of Homeland Security.
    • “Senate Majority Leader John Thune, R.S.D., said Monday he hopes to confine the bill to the narrow mission of funding Immigration and Customs Enforcement and the Border Patrol. “
  • HR DIve relates,
    • “Secretary of Labor Lori Chavez-DeRemer resigned on Monday, she confirmed in a post to her official X account, ending her tenure after just over one full year leading the U.S. Department of Labor.
    • “Chavez-DeRemer’s departure followed recent reports that the agency’s inspector general had launched an investigation into her potential misconduct, including contact between her family and department staff. Similar previous inquiries reportedly led to the departure of employees including Chavez-DeRemer’s chief of staff and deputy chief of staff.
    • “Chavez-DeRemer said in her post Monday that under her watch, DOL “created new pathways to mortgage-paying jobs, prepared workers to excel in the age of AI, took steps to lower prescription drug costs, promoted retirement security, and so much more.” A White House spokesperson did not immediately respond to a request for comment.”
  • The American Hospital Association News tells us
    • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., and CMS Deputy Administrator and Director of Medicaid and CHIP Dan Brillman sat down with Bill Gassen, president and CEO of Sanford Health and AHA chair-elect, for a discussion about the changes that have occurred in CMS in the past year, as well as how they intend to move forward.  
    • Oz described the agency’s focus this year on working with insurers to reduce the need for prior authorizations. In addition, both Oz and Brillman spoke on the agency’s drive to reduce unnecessary spending; Oz estimated that 5% of CMS’ budget, or about $100 billion, is lost to fraud, waste and abuse.  
    • “Brillman spoke on the new community engagement standards that require most Medicaid recipients to perform a certain number of employment or volunteer hours to maintain their eligibility for benefits, which Brillman said provides “paths to prosperity” for beneficiaries, saying, “if we get someone a higher income so they no longer need services, that’s a win for all Americans.” 
    • “Technology, especially the use of artificial intelligence, was also acknowledged as an important advancement, with Oz saying that current technology offers “a generational opportunity to fix health care,” noting that “I do not see a way to make health care as great as it could be without AI.”  
    • “Oz spoke on last year’s Rural Health Transformation Fund, saying that the infusion of $50 billion over five years will have nationwide effects. “The learnings will accrue to urban centers,” he said. “[The fund] is creating a sandbox in rural areas, and what you learn will benefit all of you.” 

From the public health and medical / Rx research front,

  • Health Day reports,
    • “Reaching for the salt shaker could have long-lasting implications for your memory and brain health, a new study says.
    • “Higher sodium intake appears to affect episodic memory, the type of memory used to recall personal experiences and specific events from your past, researchers report in the June issue of the journal Neurobiology of Aging.
    • “This effect – which could cause one to forget anything from where they parked the car to their first day of school – occurred mainly among men, researchers found.
    • “No such associations were observed among women in the study, researchers said.”
  • The American Medical Association lets us know seven things patients should know about protein maxxing.
  • Healio relates,
    • “Prescriptions for direct-acting antivirals to treat hepatitis C virus in the U.S. have declined substantially since 2015 and remain well below the approximately 260,000 annual treatment courses needed to meet the target for elimination.
    • “Results of a national cross-sectional analysis showed annual treatment volume trending alongside HCV infection rate, rather than surpassing it.
    • “We’re roughly treating the same number of people each year as there are new infections,” Sanjay Kishore, MD, assistant professor at University of Virginia School of Medicine, told Healio. “We’re essentially just holding steady and not actually making any progress.” * * *
    • “I think we need to think creatively about using things like mobile clinics to take care of people. We need to really lean into telehealth on this issue, and we need to expand screening to places where people are getting addiction treatment. Maybe instead of a hospital, it’s a rehab facility or a syringe exchange. We need to make it easier to connect with clinicians and get treatment to meet people where they are.”
  • MedPage Today tells us,
    • “Adults whose type 2 diabetes was treated with GLP-1 receptor agonists were more than likely to develop cognitive impairment over 10 years than their counterparts not treated with GLP-1 agents, a propensity-matched retrospective study of nearly 65,000 patients suggested.”
  • and
    • “Lower hemoglobin levels were linked with higher dementia risk over 9 years of follow-up.
    • “Anemia was associated with elevated Alzheimer’s blood biomarkers including p-tau217 and neurofilament light chain.
    • “Dementia risk was highest when anemia coexisted with abnormal Alzheimer’s biomarkers.”
  • BioPharma Dive offers news from the annual meeting of the American Association for Cancer Research and informs us,
    • “An experimental autoimmune drug from Nektar Therapeutics helped people with alopecia areata who’d already responded to the treatment in a Phase 2 trial grow more hair as time went on, the company said Monday.
    • “The data released Monday measured hair regrowth after 52 weeks of treatment with the therapy, known as rezpegaldesleukin. Nektar disclosed last year that the therapy failed to show a statistically significant benefit over a placebo after 36 weeks. The company, though, blamed that result on the inclusion of four patients that shouldn’t have been eligible and said the findings supported additional development.”
  • Fierce Pharma points out,
    • “Sanofi’s protein-based vaccine Nuvaxovid has conquered Moderna’s next-generation messenger RNA shot mNexspike in a head-to-head trial assessing the tolerability of the two COVID vaccines.
    • “In the phase 4 double-blind, real-world study, which included 1,000 adult participants in the United States, Nuvaxovid showed statistically significant fewer side effects across all pre-specified endpoints.
    • “Symptomatic reactions with Nuvaxovid were both milder and shorter than with mNexspike. Additionally, less than 10% of those who received Nuvaxovid experienced severe side effects—such as fatigue, headache or fever which prevented them from conducting their daily activities—compared to 20% of those who got mNexspike. As for injection site symptoms such as pain, redness and swelling, they were more than 75% more frequent for those who received Moderna’s shot.”

From the U.S. healthcare business front,

  • ‘Per a Lockton news release,
    • “Lockton’s eighth annual survey of over 1,700 U.S. employers helps employers compare their benefit strategies with those of other employers -providing benchmark data, highlighting trends, and illuminating new ideas.
    • “As healthcare costs rise and economic pressures mount, cost is a defining reality for employers. The 2026 Lockton National Benefits Survey shows a rapid acceleration of a shift that first took hold last year – cost management decidedly the top priority vs the next ranked priority – attracting and retaining talent. The data shows how employers are searching for an answer to their need for cost containment solutions.
    • “To gain further insights into the 2026 survey findings, you can access the executive summary here.”
  • The Peterson / KFF Health System Trackers identifies recent trends in employer-based health coverage.
    • “Key takeaways include:
      • “In March 2025, 60.0% of the non-elderly, or about 165.6 million people, had employer sponsored insurance or ESI. 
      • “About four in five (80.4%) adult non-elderly workers worked for an employer that offered ESI to at least some employees, a share that has been consistent over recent years. 
      • “The share of workers eligible for ESI at their job declined slightly over the past few years, from 75.3% in March 2023 to 74.6% in March 2025. 
      • “Most eligible workers who do not take up ESI offered at work cite other coverage (63.0%) and cost (30.2%) as the reason.”  
  • Beckers Hospital Review tells us,
    • “As more care shifts outside hospital walls, health system leaders are rethinking how they plan, staff and structure their workforces to support a rapidly expanding ambulatory footprint.
    • “Outpatient services accounted for 57% of hospital revenues in 2024, up from 52% in 2020, according to the American Hospital Association. The AHA’s Sg2 forecasting model projects outpatient volumes will grow another 17% over the next decade. At the same time, many health systems are accelerating ambulatory investments in 2026 to support financial sustainability and expand access closer to home.”
  • MedCity News notes that “Expanding the CJR Model Is a Logical Step in Value Based Care, but Implementation Challenges Remain.”
    • “CMS is proposing to make its joint replacement bundled payment model mandatory nationwide. Experts say it is a logical step, but warn that mandatory participation could be challenging for hospitals to implement.”
  • Healthcare Dive relates,
    • “Physician burnout continues to decline across the U.S., a bright spot for an occupation plagued by heavy workloads, pervasive stress and high stakes. But the improvement is not equal across medical specialties, according to new data from the American Medical Association.
    • “The AMA surveyed thousands of physicians and found that 41.9% reported experiencing a burnout symptom in 2025, down from 43.2% in 2024 and 48.2% in 2023. The decline likely reflects employer efforts to reduce burnout, including by increasing job satisfaction, the medical association said.
    • “However, burnout rates vary significantly across specialties, and tend to be higher among doctors employed by hospitals, suggesting health systems could be doing more to ameliorate the phenomenon.”
  • Fierce Healthcare informs us,
    • “UnitedHealthcare is building on its work to support rural hospitals and will now exempt these facilities from most prior authorizations.
    • “The insurance giant said in an announcement on Monday that the shift will apply across all lines of business. In addition, UHC will accelerate payments by up to 50% for about 1,500 rural hospitals and all critical access hospitals across the country.”
  • and
    • “Just over two years ago, Highmark joined forces with Spring Health to launch a new mental well-being platform that made it far easier for members to access critical services.
    • “Now, the partners are offering a look at how that program has worked for members. In a paper published last month, researchers at Highmark reported that patients waited less than two days on average in 2025 to access an appointment.
    • “Spring’s platform is embedded directly into Highmark’s member app, and that integration was a key part of what made the program work, according to the analysis. Members can easily find mental well-being tools and complete a self-assessment upon connecting for the first time, which allows Spring to build a personalized approach.”
  • The Wall Street Journal points out,
    • “Eli Lilly struck a deal to acquire Kelonia Therapeutics for $3.25 billion upfront and up to $7 billion if certain milestones are reached. 
    • “Kelonia is developing a next-generation CAR-T therapy for multiple myeloma, which promises to transform treatment without chemotherapy.
    • “The acquisition positions Eli Lilly to enter a lucrative segment of the global cancer-drug market and bolster its cancer offerings.”
  • MedTech Dive adds,
    • “Medtronic said Monday it has closed the acquisition of CathWorks, a deal worth $585 million with potential undisclosed earn-out payments.
    • “The transaction, agreed to in February, continues a strategy of increasing acquisitions to strengthen the company’s leadership in its core businesses, Medtronic said.
    • “CathWorks’ FFRangio system uses artificial intelligence and computational science to assess the entire coronary tree from routine angiograms that image the blood vessels.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. sought to distance himself from U.S. measles outbreaks on Friday at a House Education and Workforce Committee hearing on the administration’s fiscal 2027 budget request.
    • “The hearing, part of Kennedy’s weeklong tour of Congress on the budget, was relatively light on spending discussions, as Democrats who have repeatedly requested such a hearing with Kennedy looked to pin him down on a range of issues. The hearing was often combative, with Democrats drawing attention to issues such as vaccines and Kennedy’s focus on school nutrition.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services today announced the appointment of Casey B. Mulligan, PhD, as Chief Economist and Chief Regulatory Officer. Mulligan is a renowned University of Chicago economist who served as Chief Economist on the Council of Economic Advisers during the first Trump Administration. He most recently served as the U.S. Small Business Administration’s Chief Counsel for Advocacy.
    • “Mulligan will advise Health and Human Services Secretary Kennedy Robert F. Kennedy, Jr., and other agency leaders on policy development to continue to make health care more affordable for the American people. His portfolio will include cost-benefit analysis of regulation, econometric modeling, and program evaluation of major expenditures.”
  • Fierce Healthcare relates,
    • “Insurers hoping for a reprieve from an out-of-network billing system largely favoring healthcare providers will likely be left wanting as federal policymakers sit on their hands and one large payer’s bid to limit the claims faces an uphill battle, strategy firm Capstone concluded in a new report.” * * *
    • “Capstone expects any meaningful reversal of the IDR trend to most likely stem from direct action by payers. Chief among these is an administrative penalty Elevance Health implemented in 11 states for its Anthem BCBS commercial business. The policy levies a fee equal to 10% of the allowed amount on facility claims involving OON providers.
    • “The policy has faced substantial pushback from provider groups, though it still went into effect Jan. 1 in the 11 states with plans to expand similar fees in two more. Capstone noted that one of the initial states, Indiana, has already enacted legislation against the practice and that the broader policy is primed for legal challenges.
    • “However, if Elevance’s model is adopted more broadly, the OON ecosystem could shrink as facilities internalize the direct financial cost of hosting OON providers,” Capstone wrote. “In that scenario, provider groups would face pressure to either absorb the loss of facility relationships or accept often-lower in-network rates.” 
  • Bloomberg Law points out,
    • “The head of the Department of Labor’s employee benefits regulator defended how he’s changed the agency before lawmakers, saying he’s cut down on excessive litigation and enforcement.
    • “Daniel Aronowitz, leader of the Employee Benefit Security Administration, told members of a House Education and the Workforce subcommittee that the agency had reoriented its approach to follow the Employee Retirement Income Security Act, boasting that it was “the most pro-ERISA EBSA administration ever.” * * *
    • “The agency is revisiting a Biden-era [mental health] parity rule creating a comparative test to ensure employers are covering mental health equally with medical and surgical benefits. EBSA halted enforcement of the rule after The ERISA Industry Committee sued.
    • “Aronowitz noted that he didn’t believe the rule’s comparative analyses “got us anywhere. It just created cost and burden.”
    • “But he said EBSA is conducting investigations on medical necessity denials, exclusions for autism and opioid treatment, so-called “ghost networks” of unavailable doctors, and conflicts of interest.”
  • Thompson Reuters discusses this year’s obligation to provide notices of creditable coverage to Medicare Part D eligible individuals and to CMS.
    • “Sponsors of HRAs and other account-based plans, which are typically offered alongside major medical plans, will welcome the relief from providing burdensome and potentially confusing Part D creditable coverage notices. Sponsors of plans that remain subject to the disclosure requirements should use the 2027 parameters when determining whether their plans’ prescription drug coverage is creditable for that year.”
  • Healthcare Dive tells us,
    • “Employers, lawmakers, patient advocates, price transparency groups and more urged the Department of Labor to quickly finalize a rule that would force pharmacy benefit managers, shadowy middlemen in the drug supply chain, to share more pricing and compensation information.
    • “PBMs did not feel the same, according to industry comments on the proposed regulation.
    • “The rule has been caught up between two powerful industries — healthcare purchasers like employers and the PBMs they contract with to manage their drug benefits — since it was proposed in January, amid growing criticism of PBMs and a broader bet from the Trump administration that better price transparency will lower healthcare costs.”
  • and
    • “The CMS has proposed repealing the alternative pathway for new technology add-on payments, or NTAP, beginning in fiscal year 2028. The change is included as part of the 2027 Inpatient Prospective Payment Systems proposed rule. 
    • “Under the proposal, medical devices with breakthrough device designation would be required to meet the same eligibility criteria as other available technologies to receive the additional payments under the NTAP pathway.
    • “Industry trade group AdvaMed said the alternative pathway policy, implemented by the first Trump administration, has worked well. AdvaMed, in an emailed statement to MedTech Dive, said “it would be disappointing if this progress were rolled back.”

From the Food and Drug Administration front,

  • Healio reports,
    • “The FDA has cleared an HPV self-collection kit and approved a related HPV assay for at-home use, enabling patients to obtain their own sample for cervical cancer screening.
    • “The Onclarity HPV Self-Collection Kit (Waters Corp.) is tested with the BD Onclarity HPV Assay (Waters Corp.), which now supports specimens collected both in clinic and at home. The assay detects all high-risk, carcinogenic genotypes and is the only FDA-approved HPV assay to identify “six individually and three groups of pooled results,” according to a manufacturer press release.
    • “The at-home, self-collection kit could help reduce barriers for unscreened or underscreened individuals, who comprise nearly 60% of cervical cancer cases.”
  • MedTech Dive relates
    • “Philips has received Food and Drug Administration clearance for an artificial intelligence-enabled CT system.
    • “The 510(k) clearance, which Philips disclosed Thursday, covers a Verida device that the company claims reduces image noise by 80% and reconstructs scans twice as fast as its predecessor.
    • “Jie Xue, chief business leader for precision diagnosis at Philips, recently said Verida’s throughput sets it apart from photon-counting CT technology. GE HealthCare and Siemens Healthineers sell photon-counting devices.”
  • CVS Health informs us,
    • “New treatments take years of research, clinical trials, and regulatory review before reaching patients. Several therapies approaching FDA decisions this spring could expand treatment options for people managing a range of conditions.
    • “CVS Caremark’s Clinical Pipeline Services team — made up of licensed clinical pharmacists and analysts — monitors new therapies moving through the drug pipeline and evaluates what those approvals could mean for members. The team’s latest Drugs to Watch report identifies several notable therapies with decisions expected between April and June 2026, including:
      • “A new oral option for patients with treatment-resistant hypertension
      • ​​​”A more convenient, at-home format for early Alzheimer’s disease treatment that avoids lengthy IV infusions​​​​​​​​​​
      • “The first FDA-approved treatment for a chronic ​​​​liver infection
      • “An additional non-nicotine option for adults looking to quit smoking.”

From the judicial front,

  • Bloomberg Law reports,
    • “A wave of hospital bankruptcies has brought in its wake high-stakes lawsuits aiming to boost creditor payouts by targeting health insurers over allegedly systemic claim denials.
    • “At least nine different health insurers in the past six months have been sued by bankruptcy estates or trustees appointed under bankruptcy plans for three major health-care businesses, according to court documents reviewed by Bloomberg Law. 
    • “Lawsuits against insurers for Steward Health Care System LLC, CarePoint Health Systems Inc., and Jackson Hospital & Clinic Inc. seek a combined $427.9 million and represent 32,000 patient claims across 32 hospitals and providers and six states.
    • “The litigation is ramping up as hospital bankruptcies accelerate amid disputes over private equity ownership, real estate investment trust structures, and federal cuts.” * * *
    • “A trustee for CarePoint, which operated three New Jersey safety-net hospitals before it filed for Chapter 11 in November 2024, sued Cigna Health & Life Insurance Co. in February. It argued Cigna underpaid its hospitals for various services by more than $114 million.
    • “Steward’s trustee filed at least seven lawsuits against insurers, including Blue Cross of Florida, CareSource Ohio, and Aetna Health, seeking to recover more than $63 million and alleging they withheld valid reimbursements.
    • “Jackson Hospital took a different approach, bringing a more than $250 million antitrust suit against Blue Cross and Blue Shield of Alabama in December. The insurer used market domination to allow for a pattern of baseless claim denials for emergency care, the suit said.”

From the public health and medical / Rx research front,

  • The Centers for DIsease Control and Prevention announced today,
    • “COVID-19
      • “COVID-19 activity is low in most areas of the country.
    • “Influenza
      • “Seasonal influenza activity continues to decrease. Influenza A activity is low across all HHS regions and influenza B activity continues to trend downward.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means higher levels of RSV activity may continue through April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • “National vaccination coverage for COVID‑19, influenza, and RSV remained low among both adults and children. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News reports,
    • “There are now 602 cases in the Utah measles outbreak, the state’s Department of Health and Human Services reported April 14. Of those, 405 cases have been diagnosed this year. The confirmed total of measles cases reported nationwide in 2026 has increased to 1,748, according to the latest data from the Centers for Disease Control and Prevention. There have been 19 reported outbreaks across 33 jurisdictions. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape adds,
    • Use of preexposure prophylaxis (PrEP) for HIV prevention in adolescents and young adults is “strikingly low,” though youth aged 13-24 years have nearly 1 in 5 new HIV infections in the US, according to a new study in JAMA Pediatrics. Use is particularly low in women and young people who live in the South and Midwest.
    • “Efforts to expand PrEP use among youths should address geographic disparities, legal and policy barriers, and clinician engagement to improve equitable access to HIV prevention,” the authors wrote, led by Nicholas Venturelli, MD, MPH, with Boston Children’s Hospital in Boston.
  • The University of Minnesota’s CIDAP relates,
    • “Historically, shigellosis cases in the United States have primarily been seen in young children in daycare settings and in people who’ve traveled to countries with poor sanitation. Infections with Shigella, a gut pathogen that causes diarrhea and vomiting, have also been fairly easy to treat.
    • “But the profile of who’s most at risk of shigellosis is changing, and the infections is becoming much harder to treat, according to a report published last week in Morbidity and Mortality Weekly Report, the flagship publication of the Centers for Disease Control and Prevention (CDC).
    • “In the report, researchers from the CDC and health departments across the country revealed that the vast majority of US Shigella infections from 2011 through 2023 were in adult men, a high proportion of whom (47%) had HIV. Analysis of nearly 17,000 Shigella isolates found that the proportion of isolates considered extensively drug-resistant (XDR) rose from 0% during 2011-2015 to 8.5% in 2023. 
    • “Approximately one-third of patients were hospitalized. And among patients with travel history, more than 80% reported no recent international travel.
    • “The report’s corresponding author said the findings reflect changes in epidemiology and resistance that are transforming Shigella from a primarily self-limiting infection that rarely required antibiotics into an emerging public health threat with limited treatment options. 
    • “Together, it’s a very concerning pattern of XDR Shigella strains that are being seen among vulnerable populations,” Naeemah Logan, MD, an epidemiologist with the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, told CIDRAP News.”
  • The AP informs us,
    • “The worrisome rise in colorectal cancer deaths in younger adults is concentrated in people with less education, suggesting socioeconomic factors could be driving the escalation, according to a new study.
    • “Celebrity deaths — including Chadwick Boseman in 2020 and James Van Der Beekearlier this year — have highlighted the increase in colorectal cancer deaths among younger adults, but the new paper was called the first to parse which people are most affected by the alarming rise. 
    • “The researchers found that over the last 30 years, the rise in colorectal cancer deaths in young adults occurred almost entirely among people without a four-year college degree.
    • “Of course, getting a college degree doesn’t protect you from getting colon cancer. Rather, experts say it’s a marker for other issues: People without degrees tend to earn less money, have poorer diets, exercise less and get less medical care.
    • “It’s not totally unexpected that the death risk is concentrated in the less advantaged, but the paper published Thursday in JAMA Oncology is the first national study to actually show the connection, said Dr. Paolo Boffetta, a researcher at Stony Brook Cancer Center in New York who wasn’t involved in the work.” 
  • The New York Times points out,
    • “Researchers at the University of Pittsburgh reported on Friday that they had trained the immune systems of a few patients to accept liver transplants without the drugs needed to avoid organ rejection.
    • “Three of eight patients have now been off the drugs for at least three years, perhaps an early step toward a new approach to transplantation that experts in the field have long hoped for. The study was published in Nature Communications.
    • “They’ve gone a long way toward proving a principle,” said Dr. William Jarnagan, chief of liver and transplant surgery at Memorial Sloan Kettering Cancer Center, who was not involved in the study.
    • “With further development, it could really be a game changer,” he added.
    • “Dr. Joohyun Kim, a liver transplant surgeon at Yale who was not involved with the study, said, “Even 10 years ago, people thought ‘tolerance induction’ was a dream.”
  • The Genetic Engineering and Biotechnology News adds,
    • “The American Association for Cancer Research (AACR) Annual Meeting kicks off this weekend in San Diego. A whirlwind of sessions, keynotes, fireside chats, posters, and exhibitors, the meeting is THE annual event for the cancer community.
    • “Before the conference, GEN spoke with AACR program chairs Paul S. Mischel, MD, Professor and Vice Chair for Research for the Department of Pathology at Stanford Medicine of Stanford University and Alice T. Shaw, MD, PhD, Chair of the Department of Medical Oncology and the Chief of Strategic Partnerships at Dana-Farber. In this interview, they share their perspectives on the event, what attendees should be looking out for, and what they, personally, are most looking forward to.”
  • and
    • “For pathogens like HIV, malaria, and rapidly evolving influenza strains, coaxing the immune system to produce the rare, highly potent antibodies needed for protection has long been a scientific bottleneck. Vaccines can train B cells to evolve such broadly neutralizing antibodies, but only under ideal conditions—and only in a small fraction of people. Even attempts to genetically edit mature B cells produced responses that faded as the cells died out.
    • “A team at The Rockefeller University has now taken a more upstream approach: programming hematopoietic stem and progenitor cells (HSPCs)—the source of all B lymphocytes—to carry permanent genetic instructions for therapeutic antibodies or other proteins. Because the immune system naturally amplifies rare, useful cells after vaccination, even a tiny number of edited stem cells can seed a durable, boostable immune response.
    • “The immune system is inefficient in that it produces a vast quantity of cells to protect itself,” said Harald Hartweger, a research assistant professor in Michel Nussenzweig’s Laboratory of Molecular Immunology. “We wanted to take advantage of the immune system’s ability to amplify useful, rare cells.”
    • “The study, published in Science and titled “B lymphocyte protein factories produced by hematopoietic stem cell gene editing,” demonstrates that CRISPR‑edited HSPCs can mature into B cells that express engineered antibodies upon vaccination. A standard vaccination then acts as the trigger: antigen exposure drives those edited B cells to expand, differentiate into plasma cells, and secrete high titers of the inserted antibody that last long-term.”

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

  • Fierce Healthcare reports,
    • “The Purchaser Business Group on Health has released new data that highlights some of the key healthcare priorities of its jumbo employer members, with—perhaps unsurprisingly—the escalating affordability crisis as the biggest challenge.
    • “Rounding out the top three priorities are data analytics and transparency, as well as an interest in advanced primary care. PBGH based the findings of a survey of more than two dozens of its members, which represent some of the largest employers in the United States.
    • “Elizabeth Mitchell, president and CEO of PBGH, said in an interview that the escalating cost pressures have driven “a much more proactive approach from our members to address these concerns, which are simply not being addressed by the industry.”
    • “The urgency of that concern is absolutely growing,” Mitchell said. There is “also a heightened focus on transparency and understanding prices, and we are enabling that because they cannot just keep writing blank checks to the healthcare system when they have poor outcomes and just no demonstrable improvement in quality or value.”
  • Beckers Hospital Review informs us,
    • “Little Rock, Ark.-based Baptist Health reached a definitive agreement to acquire Magnolia (Ark.) Regional Medical Center.
    • “The deal, subject to customary regulatory approvals, is expected to be completed by July 12, according to an April 16 Baptist news release. On that date, the hospital will be rebranded as Baptist Health Medical Center-Magnolia.
    • “While it is an extremely challenging time to operate community hospitals, we have a proven track record of operating rural hospitals successfully in Arkansas,” Baptist President and CEO Troy Wells said in the release.”
  • and
    • “Mark Cuban has a pitch for hospitals: Manufacture drugs in their own parking lot.
    • “Mr. Cuban’s Cost Plus Drugs previously launched a Dallas-based manufacturing facility to address supply issues, starting with epinephrine and norepinephrine production. More recently, Mr. Cuban said his facility can also produce Pitocin, pediatric cancer drugs and sterile water — and that generic tablets can be cheaper when made in Dallas versus purchased from India.
    • “During Becker’s Spring 2026 Chief Pharmacy Officer Summit, Mr. Cuban explained how Cost Plus — which includes pharmacy, contracting, procurement and manufacturing businesses — is “modularizing” its manufacturing facilities.
    • “We’ve been able to take the manufacturing facility we have in Dallas and not only make it much smaller than what everybody else has done to that point, but we’ve been able to modularize them and put them in a pod that is effectively a tractor trailer,” Mr. Cuban said. “The trailers that go on the back that you see going down the road — we can manufacture sterile injectables in that tractor trailer.”
    • “Cost Plus is selling these manufacturing pods, which can be deployed anywhere from hospital sites to disaster zones to research facilities. He said rare disease therapies that historically cost upward of $500,000 and took six months to produce can now cost roughly $50,000 and possibly take less time.
    • “That, literally, over the long term, is going to be our biggest business and will save the most lives and money,” he said. “The more efficient we become at using robotics and AI, the less expensive we can manufacture drugs.” 
  • BioPharma Dive relates,
    • “Through an acquisition announced Friday, Belgian drug company UCB is wagering more than $1 billion on a cutting-edge medicine that’s being tested as a potential therapy for a few seizure disorders as well as Alzheimer’s disease.
    • “UCB offered to buy privately held Neurona Therapeutics for $650 million up front while dangling another $500 million in future, milestone-based payments. If completed, the deal would hand UCB an experimental therapy that uses pluripotent stem cells engineered to calm the brain and repair neural networks.
    • “The therapy, codenamed NRTX‑1001, is currently being evaluated in clinical trials as a treatment for patients with hard-to-treat forms of a common epilepsy rooted in the “mesial temporal lobe” part of the brain.”
  • and
    • “Kailera Therapeutics, a high-profile drug startup aiming to compete with Novo Nordisk and Eli Lilly in obesity, said Thursday it banked $625 million in one of the sector’s largest-ever initial public offerings.
    • “The IPO haul far surpasses the $500 million it set out to raise in terms set earlier this week. Kailera sold more than 39 million shares at $16 apiece. It’ll begin trading on the Nasdaq stock exchange on Friday under the ticker symbol “KLRA.”
    • “Kailera’s offering is among the biggest, by total proceeds, raised by a venture-backed biopharmaceutical company, according to BioPharma Dive data. Its IPO eclipses Acelyrin’s $540 million stock sale in 2023, Sana Biotechnology’s $588 million issuance in 2021, and Moderna’s then-record $604 million pricing in 2018.”
  • MedTech Dive lets us know,
    • “GE HealthCare is expanding a mammography collaboration with RadNet subsidiary DeepHealth.
    • “The partnership brings more of DeepHealth’s artificial intelligence tools to GE HealthCare’s mammography machines, including a workflow for complex cases that may benefit from a secondary review.
    • “The companies announced the expanded initiative at the Society of Breast Imaging Annual Symposium on Thursday.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network offers an interview with Tammy Flanagan about how “health‑coverage decisions in retirement can shape when and how federal retirees tap their money.”
  • Govexec reports,
    • “The percentage of federal employees who are classified as “thriving” decreased by 10 points between 2024 and 2025, according to a recent report from Gallup, which sheds light on how civil servants are reacting to cuts and other reforms that President Donald Trump has made to agencies since the start of his second term. 
    • “By taking the average of responses from quarterly surveys conducted respectively in both years, the analytics firm found that the percentage of “thriving” feds dropped from 58% in 2024 to 48% in 2025.” * * *
    • “While the “thriving” rate for federal employees held steady at around 60% from 2022 to 2024, the latest data puts them on par with the average for U.S. workers in general, which also stood at 48% in 2025. That broader group, however, saw a smaller decline, going from 51% in 2024.”
  • OPM has brought the Director’s Secrets of OPM blog posts up to date on the agency’s website, which may be more easily accessible than Substack.
  • Per a CMS email,
  • This reporting requirement applies to FEHB and PSHB plans.
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services April 9 held a demonstration showcasing the first series of products intended to push the health care industry toward a more connected ecosystem. The event highlighted tools and applications from more than 50 companies supporting the Medicare App Library that was initially announced in February. Tools intended to promote digital data access and eliminate manual check-in forms were featured, along with personalized health apps providing tailored guidance for nutrition, wellness and chronic disease management.” 
  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services has proposed a 2.4% payment rate bump for inpatient services for fiscal year 2027 as well as the first mandatory, nationwide test of an episode-based payment model. 
    • “The plans were outlined Friday in the annual release of CMS’ Inpatient Prospective Payment Systems (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System proposed rule. 
    • “Other planned changes, according to a fact sheet from the agency and the proposed rule’s summary, include various measure additions or modifications to measures in the Hospital Inpatient Quality Reporting Program; adjustments to the Transforming Episode Accountability Model (TEAM) alternative payment model controversially finalized in last year’s rule; and changes to graduate medical education payments to implement discrimination requirements aligned with the administration’s view of diversity, equity and inclusion practices.” 
  • A CMS news release adds,
    • “Medicare beneficiaries undergoing knee, hip, and ankle replacements, among the most frequent surgeries for people with Medicare, could soon experience more coordinated care and lower costs under a new Centers for Medicare & Medicaid Services (CMS) proposal. CMS is looking to implement these improvements by expanding the Comprehensive Care for Joint Replacement (CJR) Model nationwide through the Fiscal Year (FY) 2027 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule.
    • “Every year, Medicare funds thousands of knee, hip, and ankle replacements that help seniors keep up with their speedy little grandkids,” said CMS Administrator Dr. Mehmet Oz. “This proposed expansion of our successful joint replacement pilot program would better align financial incentives with improved health outcomes—protecting taxpayer dollars while ensuring patients get the care they need before, during, and after surgery.” * * *
    • “To learn more about the CJR-X Model, including independent evaluation reports, visit: https://www.cms.gov/priorities/innovation/innovation-models/cjr-x“
    • “The FY 2027 IPPS and LTCH PPS proposed rule can viewed on the Federal Register at: https://www.federalregister.gov/public-inspection/current. 
    • “For a fact sheet on FY 2027 IPPS and LTCH PPS proposed rule, visit: https://www.cms.gov/newsroom/fact-sheets/fy-2027-hospital-inpatient-prospective-payment-system-ipps-long-term-care-hospital-prospective.”
  • Fierce Healthcare relates,
    • “The Trump administration has issued a proposed rule that aims to significantly overhaul prior authorization for pharmaceuticals.
    • “Through the Interoperability Standards and Prior Authorization for Drugs rule, the Centers for Medicare & Medicaid Services said it would establish deadlines for payers in government insurance plans, setting the timeline at 24 hours for urgent requests and 72 hours for standard determinations.
    • “In addition, the rule would require insurers to publicly report certain metrics around prior authorization, including approval and denial rates; outcomes for appeals; and decision timeframes, according to an announcement from the agency.”
    • “The rule also builds on a 2024 regulation that took aim at prior authorization for non-drug services as well as payers’ 2025 pledge to significantly overhaul their approach to prior auth, an agreement brokered in part by CMS officials.” * * *
    • “CMS would also push to adopt Fast Healthcare Interoperability Resources (FHIR)-based standards for the small number of plans still using older models, making it easier for real-time electronic workflows to thrive.”
  • and
    • “Despite encountering a legal roadblock last month in his effort to rework the U.S. vaccine infrastructure, HHS secretary Robert F. Kennedy Jr. is continuing to reshape the Centers for Disease Control and Prevention’s vaccine advisory panel in a way that’s setting off alarm bells for some experts.
    • “In the new charter for the Advisory Committee on Immunization Practices (ACIP), the focus of the group—which helps advise the CDC on vaccine schedules and recommendations—seems to be shifting more toward concerns around vaccine safety and side effects. 
    • “In particular, the panel will now work on identifying “gaps in vaccine safety research, including adverse effects following vaccination.” The language is new in the updated charter and will likely appease the vaccine skeptic crowd, which has long used the potential for vaccine injuries and erroneous links to the development of neurological disorders like autism to further their cause.
    • “The group will also now specifically be tasked with reviewing new vaccine platforms such as mRNA shots, which have become a frequent bugbear in anti-vaccine rhetoric following the COVID-19 pandemic.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has, for the second time, turned back a medicine for a tough-to-treat skin cancer in a decision that marks a major setback for the therapy and its developer, biotechnology company Replimune.
    • “The agency on Friday rejected the treatment, vusolimogene oderparepvec or “RP1,” which had been under review for people whose advanced melanoma progresses despite treatment with a widely used cancer immunotherapy. In a letter made public Friday, the agency claimed that the review team, as well as multiple agency leaders and subject matter experts, determined the data are “insufficient to conclude substantial evidence of effectiveness.”
    • “The decision comes eight months after U.S. regulators spurned RP1, arguing that the company’s findings couldn’t be “adequately interpreted.” Replimune claimed to have been blindsided by the rejection and afterwards provided the FDA with additional information and analyses to boost its case. The agency, though, argued in its letter that its feedback to Replimune has remained consistent through years of communications and that its issues weren’t addressed.”
  • The Wall Street Journal relates,
    • “GSK withdrew its application for a drug touted last year by President Trump as a potential treatment for autism symptoms, just months after the company submitted it at the request of health officials.
    • “The U.K. drugmaker asked the Food and Drug Administration to pull its application for the drug leucovorin calcium because it doesn’t market the medicine, according to a regulatory filing posted Thursday. 
    • “The FDA had just approved leucovorin last month. Generic forms of the medicine will still be available. * * *
    • “GSK hadn’t sold the drug since 1999. At the request of the Food and Drug Administration, GSK said in September it would submit its application for patients with cerebral folate transport deficiency—a rare genetic condition with similarities to autism—in a move that allowed the agency to update the label for the drug and its generic counterparts. 
    • “FDA officials last month announced they had approved the drug for that condition based on a review of existing studies, but said in a call with reporters that they hadn’t found enough evidence to merit OK’ing the drug’s use to treat autism more broadly.
    • “Senior FDA officials said they examined scientific studies to see whether they could approve leucovorin to treat autism, but didn’t come up with enough strong scientific evidence to do so.
    • “A spokesman for HHS said GSK’s withdrawal on Thursday doesn’t affect generic versions of the drug, which already have updated labels for the genetic condition.”
  • Cardiovascular Business tells us,
    • :The U.S. Food and Drug Administration (FDA) is warning the public that certain sizing catheters from Indiana-based Cook Medical should no longer be used due to an increased risk of cracking or breaking.
    • “The agency’s warning covers specific lots of Cook Medical’s Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters and Beacon Tip Centimeter Sizing Catheters. These devices are used for a variety of angiographic procedures, aortic interventions, peripheral interventions and vascular interventions. They are made in a variety of sizes and multiple configurations.
    • “Potential adverse events that could result include increased procedural time, harms associated with device fragmentation/separation and vessel injury,” according to the FDA. “In a worst-case scenario, device fragmentation and separation could cause life-threatening harm or death.”
    • “At this time, the FDA noted, no serious injuries or deaths have been linked to this issue. The agency is still reviewing the situation.
    • “The FDA’s early alert can be read in full here. It also includes a full list of all affected product lots.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “Even as the US respiratory illness season continues to ebb, it remains deadly, with the Centers for Disease Control and Prevention (CDC) documenting 12 more pediatric deaths in its FluView update today. 
    • “So far this season, 139 children have died from the virus, and about 85% with a known vaccination status were unvaccinated. While the CDC has classified this flu season as moderate for adults, it’s been high-severity for children.
    • “For comparison, in the previous three flu seasons the CDC logged 187, 210, and 296 flu-related deaths for the complete season. The 289 pediatric deaths in 2024-25 was the most since the 2009-10 H1N1 flu pandemic.
    • “Only four jurisdictions were reporting moderate flu activity last week, and none saw high activity. Flu accounted for 8.2% of viral respiratory diseases, down from 9.8% the previous week. A total of 2,589 people were hospitalized, compared with 3,050 the week before. The proportion of outpatient visits for flu declined to 2.4% from 2.6% the previous week.” * * *
    • “The level of acute respiratory illness causing people to seek medical attention is very low. Rates of respiratory syncytial virus (RSV) remain elevated, but the virus is past peak in many areas of the country, the CDC said in its weekly respiratory virus activity update today.
    • “COVID-19 levels are low in most parts of the country, and viral wastewater concentrations are low for RSV and very low for COVID-19 and influenza A.” 
  • The American Hospital Association adds,
    • “The Utah measles outbreak has increased to 583 cases, the state’s Department of Health and Human Services reported April 7. Of those, 386 cases have been diagnosed this year. Nationwide, there have been 1,714 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 94% of cases are outbreak-associated and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.” 
  • Harvard Professor of Pediatrics Dr. David S. Ludwig opines in STAT News
    • “Targeting ultra-processed foods would make packaged foods less tasty and appealing, but no less fattening.
    • “Ironically, many products now emblematic of ultra-processed foods were developed in response to calls from nutrition scientists and government to replace dietary fat with carbohydrates, a misguided campaign that did more harm than good. We can’t afford another sweeping restructuring of the food supply based on imprecise interventions and uncertain science.
    • “Instead, focusing on processed carbohydrates offers a more precise and pragmatic solution, one that could invite collaboration with, rather than opposition from, the food industry.
    • “Delicious, calorie-rich food — whether home-prepared or packaged — isn’t the problem. What matters is how long we stay satisfied (satiety) relative to calories consumed. A 100-calorie snack or a sugary beverage isn’t better for our waistline than 200 calories from nuts if the lower-calorie option leaves us hungry and craving more soon after.
    • “By targeting the dietary drivers of weight gain, rather than misleading notions about food palatability and pleasure, we can have our (low-carb) cake and eat it, too.”
  • STAT News also tells us,
    • “With thousands of illegal e-cigarettes for sale in the U.S., both the Trump and Biden administrations have vowed to crack down on the illicit fruit- and candy-flavoredvapes that hold particular appeal to minors. But a new government report suggests law enforcement efforts by the Department of Justice lag far behind the scope of the problem. 
    • “Most DOJ enforcement actions between fiscal year 2022 and fiscal year 2025 — 50 out of a total of 88 — were to add the names of remote e-cigarette sellers to a list of unauthorized businesses, according to the report from the Government Accountability Office. The second-most common type of enforcement actions (20 out of 88) noted in the report were injunctions to stop legal violations. 
    • “The GAO report was focused on actions that involved the DOJ, so those tallies do not take into account enforcement actions like the seizure of more than 6 million illegal products by the Food and Drug Administration and U.S. Customs and Border Protection between 2024 and 2025. To put those seizures in context, a large seizure of $76 million worth of products in 2024 — 3 million vapes — equated to about 4% of China’s e-cigarette exports to the U.S. in a single month, said Steven Xu, an adjunct assistant professor at the University of Waterloo who studies e-cigarettes.
    • “Sen. Dick Durbin (D-Ill.), who requested the report, said it shows that much more work needs to be done to combat the public health threat posed by illegal vapes.”
  • Health Day informs us,
    • “Standard cognitive tests may fail to capture early brain changes in women 
    • “Women’s brains often show a steeper and more widespread decline than men’s when moving from mild impairment to Alzheimer’s
    • “Sex-specific standards may be needed to interpret brain scans and screening results accurately.”
  • and
    • “Cardiovascular health may impact fracture risk in women after menopause, according to a study published online March 27 in The Lancet Regional Health-Americas.” * * *
    • “Many of the same factors that protect your heart — regular physical activity, a balanced diet rich in calcium and vitamin D, not smoking and managing conditions like diabetes and high blood pressure — also help protect your bones,” Hossain said in a statement. “If you’ve been told you have intermediate or high cardiovascular risk, particularly if you are a postmenopausal woman, it may be worthwhile to talk to your doctor about bone health screening, given the many effective treatments available that reduce fracture risk.”

From the U.S. healthcare business front,

  • Beckers Payer Issues shares a boatload of Blue Cross Blue Shield updates.
  • Healthcare Dive reports,
    • “Menopause has come out of the shadows and into the public spotlight in recent years. Celebrities have become more eager to dish about hot flashes and night sweats, and a flurry of telehealth start-ups promising relief from a broad constellation of symptoms have given rise to a $17 billion menopause market.
    • “But demand for treatments still far outpaces the science, as persistent structural barriers confound the women’s health space. 
    • “People have taken up the charge and are trying to make an impact in a specific area,” said Kim Dalla Torre, an EY Global and Americas Health leader.” * * *
    • “More also needs to be done to raise women’s awareness that menopausal symptoms shouldn’t be something they need to tolerate in silence, Dalla Torre said. Some 80% of women experiencing these symptoms don’t reach out to their doctors for help, according to the Mayo Clinic. Drugmakers also need to play a role.” 
       
  • Cigna, writing in LinkedIn, tells us,
    • “Mental fitness is essential for stress management, resilience, and workplace productivity, helping employees achieve work/life harmony.
    • “When organizations truly care about mental fitness, employees feel more supported and valued—which leads to higher engagement, fewer days missed from work, and meaningful reductions in healthcare costs for everyone.
    • “By thoughtfully weaving together mental and physical wellness programs, organizations can nurture a more vibrant and supportive workforce—leading to lasting success, greater employee retention, and the ability to attract exceptional talent.”
  • Healthcare Innovation points out,
    • “Sentara Health’s navigators are trained professionals with expertise in behavioral health, community resources, and motivational interviewing, working closely with ED teams and patients.
    • “The program started with pilot phases at select hospitals, expanding to 10 sites over a year, with ongoing data collection to measure impact and guide future improvements.
    • “Early results indicate significant reductions in readmission rates, demonstrating the program’s effectiveness in connecting patients to appropriate community-based care.”
  • Radiology Business informs us,
    • “In a bid to offer more services outside of Manhattan, Weill Cornell Medicine is planning to build a $57 million new radiology clinic in Brooklyn.
    • “The New York City academic system officially applied for the necessary state Department of Health approvals on Monday. Located in South Brooklyn’s Bay Ridge neighborhood on 86th Street, the clinic is expected to include three MRI machines, a CT scanner and ultrasound and mammography offerings, Crain’s New York Business reported. 
    • “The outpatient radiology clinic will be housed inside the NewYork-Presbyterian Bay Ridge Primary Multispecialty center and marks a significant expansion for the hospital system outside of Manhattan.
    • “While it’s premature to talk about the services of this location, we are always striving to meet the healthcare needs of New Yorkers in their own neighborhood,” Robert J. Min, MD, radiology chair and president and CEO of the Weill Cornell Physician Organization, told Radiology Business by email April 9. “We are still in the planning stages and will share details in the coming months.”
    • “Weill Cornell hopes the new center will help alleviate demand for radiology services in Brooklyn and the surrounding communities, according to the state application. The project is part of a bigger push by Weill Cornell and NewYork Presbyterian to expand their outpatient footprint across the city, local news outlet Hoodline reported Thursday.” 

Midweek report

David Ermer–CDC, CMS, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Govexec writes about OPM’s March 31 call letter for 2027 FEHB and PSHB benefit and rate proposals.
    • “John Hatton, staff vice president for policy and programs at the National Active and Retired Federal Employees Association, said it’s not unusual for administrations to promote their health policy priorities—or to seek cost savings—via FEHBP. While the letter likely won’t lead to huge shifts in how insurers cover federal workers—or how doctors approach their patients—it does mark a noteworthy shift away from traditional medical interventions.
    • “There isn’t one thing that really stands out by itself as noteworthy, but combined the letter reflects a trend toward alternative treatments and expanding and encouraging the treatment of underlying causes rather than symptoms,” he said. “But it’s not like providers don’t already try to do that to begin with. This is a MAHA set of policies . . . but if you were expecting them to say ‘we’re banning vaccines,’ the letter is not doing that. But it does change the incentives.”
  • FEHBlog observation — What’s typical, and is occurring again, is that the new Administration’s initiatives build on top of prior Administration initiatives. As a result, carriers are caught in a spider web of federal and OPM mandates which makes it difficult to lower costs.
  • KFF Health News shares public comments on OPM’s health claims data warehouse initiative.
    • FEHBlog observation: The most secure approach would be for OPM to make aggregated data requests to FEHB plan and PSHB plan “edge servers.” This is how CMS gets health information from qualified health plans in the federal exchange.
  • Federal News Network tells us,
    • “Department of Homeland Security employees who have gone unpaid through nearly two months of a partial government shutdown will start receiving paychecks this week.
    • “In a message to all DHS employees on Monday, the office of the under secretary for management said furloughed and excepted employees would receive full salaries covering the start of the shutdown on Feb. 14 through April 4, the end of the last full pay period.
    • “Employees should start receiving paychecks as early as April 10 and no later than April 16, depending on their financial institution, according to the message.
    • “The update comes after President Donald Trump’s directive to pay all DHS employees last week.”
  • Per an HHS news release,
    • “U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. traveled to Arizona this week as part of his “Take Back Your Health” tour, meeting with leaders across health care, independent living, and recovery to drive a prevention-focused agenda.
    • “Arizona is putting prevention at the center of American health care,” said Secretary Kennedy. “By prioritizing recovery, nutrition, physical fitness, and personal empowerment, providers across this state are driving a shift from a reactive sick-care system to a true health care system that delivers better outcomes for the American people.”
  • Fierce Pharma informs us,
    • “After more than a decade in charge of the most influential organization representing the U.S. pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA), Steve Ubl will step down as its CEO at the end of the year.
    • “PhRMA’s board of directors announced the departure of Ubl on Wednesday and said it will begin a search for his successor. To ensure a smooth transition, Ubl will remain on board until a new CEO is identified, PhRMA said.
    • “Ubl is leaving during a turbulent time for the industry as President Donald Trump pursues several initiatives related to drug pricing and domestic manufacturing, and as leaders at the Department of Health and Human Services and the FDA have embraced certain controversial policies and decisions.”

From the judicial front,

  • Yesterday, the U.S. Court of Appeals for the Sixth Circuit affirmed a federal district court ruling that ERISA, which governs private sector employer sponsored health plans, preempts Tennessee’s any willing pharmacy law. This outcome supports FEHB Act preemption of the same state law.
    • FEHBlog observation — If OPM wants to lower FEHB and PSHB costs, the agency should inform state governments about FEHB Act preemption in these situations.
  • Beckers Hospital Review reports,
    • “A federal judge has declined to block the mailing of mifepristone prescriptions nationwide while directing the FDA to complete its ongoing review of the drug.
    • “U.S. District Judge David Joseph denied a request from Louisiana Attorney General Liz Murrill to pause 2023 FDA rules allowing the drug to be dispensed by mail. He instead granted a request to temporarily pause the case and said the agency must provide an update on its review within six months.
    • “The ruling allows current access to continue as legal challenges proceed, though the judge said he could revisit the issue depending on the FDA’s findings.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Some people, frustratingly, don’t lose as much weight as others on popular weight-loss drugs like Wegovy. A new study suggests the answer may be in their genes.
    • “Researchers from consumer gene-testing service 23andMe, which has one of the world’s biggest DNA databases derived from saliva samples, analyzed genetic data from 27,885 customers who have taken drugs like Wegovy and Zepbound to see if any genes or variants were correlated with how much weight people lost or how bad their side effects were.
    • “The findings, published online Wednesday by the journal Nature, showed people with a common gene variant lost more weight on GLP-1 weight-loss drugs than those without it. Researchers also found people with specific genetic variants were more likely to have side effects like nausea and vomiting from the drugs.
    • “This warrants further study,” said Dr. Noura Abul-Husn, chief medical officer at the 23andMe Research Institute. “Right now the alternative is really nothing to guide any type of personalization around how to manage expectations around GLP-1 use.”
    • “23andMe filed for bankruptcy protection last year after struggling to find a profitable business model. Testing for predictive genes could be a way for the company to salvage its business.”
  • Per a National Institutes of Health news release,
    • “A clinical trial funded by the National Institutes of Health (NIH) found that a scalable, team-based intervention strategy in federally qualified health centers (FQHCs) was able to significantly reduce systolic blood pressure for low-income participants. Scientists deployed team-based care, which included intensive blood-pressure management, blood pressure tracking and feedback to providers, health coaching on lifestyle changes and medication adherence, and home blood-pressure monitoring.  
    • “Uncontrolled high blood pressure, known as hypertension, is a major preventable risk factor for cardiovascular disease and death worldwide. According to the Centers for Disease Control and Prevention, only 1 in 4 adults with high blood pressure has their blood pressure under control. 37 million U.S. adults with uncontrolled high blood pressure have a blood pressure of 140/90 mmHg or higher. Lower income Americans experience high prevalence of hypertension and low control rates, contributing to an increased disease burden. 
    •  “Evidence-based strategies to treat uncontrolled hypertension among low-income Americans are severely lacking, even though we know this condition is a huge risk factor for more serious heart complications,” said NIH Director Jay Bhattacharya, M.D., Ph.D. “This study shows us that we can deploy an affordable, tested program to help reduce the burden of heart disease in this population.” 
  • Healio relates,
    • “People who had severe COVID-19 infections exhibited a 24% higher risk for lung cancer, retrospective data showed.
    • ‘The risk persisted throughout the 4-year follow-up period.” * * *
    • “The findings — derived from work in murine models and retrospective analyses of data from humans — underscore the importance of increased lung cancer surveillance among high-risk individuals, researchers concluded.”
  • MedPage Today points out,
    • The number of U.S. individuals on long-term opioid therapy fell from 5.6 million in 2015 to 4.2 million in 2023.
    • Co-prescribing opioids with gabapentinoids increased, however, reaching 58.7% in 2023.
    • Meanwhile, the mean age of long-term opioid therapy patients rose from 52.5 years in 2015 to 60.5 in 2023. * * *
    • “Our main finding is that while long-term opioid therapy has declined, it remains common among Americans. Also, co-prescribing with gabapentinoids rose between 2015 and 2023,” Thuy Nguyen, PhD, of the University of Michigan School of Public Health in Ann Arbor, told MedPage Today. “This is concerning because the FDA warns that concurrent gabapentin and opioid use may lead to respiratory depression.”
  • and
    • “High-flow nasal oxygen therapy has been increasingly used for noninvasive respiratory support after cardiac surgery.
    • “In the large randomized NOTACS trial, high-flow nasal oxygen therapy didn’t improve survival with maintenance of functional independence after cardiac surgery in high-pulmonary-risk patients as compared with standard oxygen.
    • “The findings suggest no need for routine provision of high-flow oxygen in this setting, although use for selected patients was not ruled out.”
  • and
    • “A national analysis of claims data found that only 1.6% of at-risk youth filled a prescription for HIV preexposure prophylaxis (PrEP) from 2018 to 2022.
    • “Minors, young women, and those living in the South faced larger disparities.
    • “Tailored and more effective interventions are needed to improve PrEP access and use in this population, the researchers argued.”
  • The American Journal of Managed Care notes,
    • “A Pediatrics review found no serious adverse events attributable to neonatal hepatitis B virus (HBV) vaccination and no evidence supporting delayed initiation of the series. 
    • “ACIP/CDC now permit optional birth dosing for infants of HBsAg-negative mothers, while maintaining mandatory vaccine plus HBIG within 12 hours for positive/unknown status. 
      • ‘Perinatal infection carries ~90% chronicity in the first year of life; timely birth dosing prevents transmission and full-series completion yields ~98% durable immunity. 
      • ‘Population-level impacts include a 99% reduction in pediatric HBV infections, with modeled reversals likely if universal birth-dose norms erode and coverage declines permanently. 
    • “Pharmacists can mitigate implementation risk by reinforcing prenatal test limitations, countering misinformation, streamlining same-day vaccination, documenting immunizations, and driving series completion follow-up.”
  • Per Fierce Pharma,
    • “For the second time in a span of four months, Insmed’s Brinsupri has come up short in a mid-stage trial designed to expand its use into a new indication. 
    • “The New Jersey biotech revealed that a phase 2b study of Brinsupri in adults with moderate to severe hidradenitis suppurativa (HS) has failed to achieve its primary or secondary endpoints for either of its 10 mg or 40 mg once-daily treatment arms. With the result, the company will terminate the program. 
    • “The flop comes after Insmed reported the misfire of another Brinsupri trial, testing the first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor in patients with chronic rhinosinusitis without nasal polyps (CRSsNP).”
  • Per BioPharma Dive,
    • “An experimental, dual-acting drug from Sanofi succeeded in two studies in different respiratory conditions but missed its mark in an eczema trial, the French drugmaker said Tuesday.
    • “Known as lunsekimig, the therapy met its main and key secondary goals in Phase 2 studies evaluating the treatment in moderate-to-severe asthma and chronic rhinitis with nasal polyps. In asthma, treatment led to a “statistically significant and clinically meaningful” reduction in symptom flare-ups and helped improve lung function. Lunsekimig reduced the size and severity of nasal polyps, as well as related congestion, in the other trial, Sanofi said.
    • “Lunsekimig didn’t meet its main objective in a separate trial in atopic dermatitis, failing to meet a certain threshold of skin clearance compared to a placebo. The drug was “generally well tolerated” across the trials, with serious adverse events and discontinuation rates comparable between treatment and placebo recipients. Two Phase 3 trials are underway in chronic obstructive pulmonary disease, another lung condition.” 

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

  • Paragon Health Institute offers an interesting analysis of the Medicare cost shift.
    • “Although the usual narrative of cost shift is a myth, it is true that government can and does artificially increase costs for private payers.”
  • Fierce Healthcare delves into the Worthy healthcare reform project initiated by Ascendiun CEO Paul Markovich and tells us,
    • “Despite artificial intelligence becoming an increasing source of health information, 85% of U.S. adults still get information from providers “at least sometimes,” a new survey finds.
    • “Researchers at the Pew Research Center surveyed 5,111 U.S. adults from Oct. 20 to Oct. 26 for the report. Aside from providers, researchers identified six other main sources of health information:
      • “People with similar health issues: 66% 
      • “Major health information websites: 60% 
      • “News organizations: 46%
      • “Government health agencies: 45%
      • “Social media: 36%
      • “AI chatbots: 22%
  • Beckers Hospital Review lets us know,
    • “The availability and affordability of healthcare tops the list of American’s concerns about key issues, according to a March 31 Gallup article.
    • “The findings are based on telephone interviews conducted March 2-18 with 1,000 U.S. adults.”
  • Health Day reports,
    • “More pregnant women have to drive long distances to get the maternity care they need, a new study says.
    • “U.S. counties that lost all hospital-based obstetric services have been hardest hit, researchers recently reported in the American Journal of Preventive Medicine.
    • “In those counties, the number of women of childbearing age who live within a half-hour drive of obstetric care fell from more than 90% in 2010 to about 60% in 2021, researchers siad.
    • “Access to maternity care is critical for the health of both the birthing person and babies,” said lead investigator Brittany Ranchoff, a research fellow at Harvard Pilgrim Health Care Institute in Boston.” * * *
    • “The National Rural Health Association has more on rural access to obstetric services.”
  • Modern Healthcare adds,
    • “Health systems struggling to fill gaps in mental healthcare are hiring staff and redeploying capital to try to keep pace with rising demand.
    • “Systems including Hartford Healthcare, Sentara Health and Northern Light Health are expanding their mental health networks and ramping up care coordination teams. Still, health system leaders fear they will not be able to move quickly enough to patch an eroding safety net for mental health patients.
    • “Nearly 23% of Americans 12 and older received mental health treatment in 2024, up from 20.6% in 2023, according to the latest national data from the federal Substance Abuse and Mental Health Services Administration. Meanwhile, 137 million people lived in areas last year where there was a shortage of mental health professionals, up 12% from 122 million in 2024, Health Resources and Services Administration data show.
    • “Avoidable behavioral health inpatient admissions are often made because there is no place to discharge to,” said Tracey Izzard-Everett, vice president of behavioral health at Norfolk, Virginia-based Sentara Health. “That leads to repeat emergency department visits.”
  • Fierce Healthcare informs us,
    • “Orlando Health is acquiring Northeast Alabama’s RMC Health System, further fleshing out the Florida-based provider’s push into its neighboring state. 
    • “Unveiled Tuesday, the deal brings five years of “significant” investment into RMC’s facilities, equipment and technology, the organizations said in their announcements. These are expected to improve patients’ access to care, including specialty services, and boost physician recruitment. 
    • “The City of Anniston, Alabama, which owns RMC, said that the transaction has been approved by its city council and the system’s board of directors. It is expected to be completed this fall, pending regulatory approvals. Financial terms were not disclosed.”
  • Per Beckers Hospital Review,
    • “New York City-based NYC Health + Hospitals has opened a 104-bed Outposted Therapeutic Housing Unit at NYC Health + Hospitals/Bellevue.
    • “The unit is designed to treat people in custody with complex medical needs by relocating clinically vulnerable detainees from Rikers Island prison to a therapeutic setting with greater access to specialty care. It marks the first of three planned units across the city, according to an April 7 news release from Mayor Zohran Mamdani’s office. 
    • “At Bellevue, patients will have access to speciality care, including oncology, cardiology and neurology, according to the release. Correctional Health Services will deliver care on site, while the city’s Department of Correction will oversee security and custody management.”
  • and
    • “Searcy, Ark.-based Unity Health on April 15 will permanently close the emergency department and medical unit at its acute care hospital in Jacksonville, Ark., a spokesperson for the health system confirmed to Becker’s. 
    • “The closure comes just three years after the hospital opened in March 2023. Unity Health plans to convert the facility into a freestanding psychiatric hospital.
    • “Unity Health-Jacksonville currently operates a 13-bed emergency department and 24-bed behavioral health unit, and provides a range of services including inpatient and observation care, imaging and inpatient cardiopulmonary services.”
  • Per BioPharma Dive,
    • “Gilead Sciences was an industry pioneer in infectious disease, bringing to market treatments that have helped turn HIV into a manageable condition and effectively cure hepatitis C. But it has struggled to branch out elsewhere — a foray into heart disease didn’t turn out well, for instance, and a long-running push into cancer hasn’t yet yielded the kind of dividends the company had hoped.
    • “Those struggles haven’t discouraged Gilead from using deals to bolster other parts of its portfolio. The company’s pipeline now includes more experimental medicines for cancer and inflammatory conditions than infectious diseases. And three acquisitions struck in quick succession in early 2026 have shown the company remains committed to growing beyond its roots in HIV. 
    • “On a conference call with analysts Tuesday, Gilead CEO Dan O’Day claimed these dealmaking moves have made the company’s portfolio the “most robust and diverse” it’s ever been.” 
  • Per Beckers Payer Issues,
    • “Thirty-six percent of providers believe payers reliably deliver on promises, according to an inaugural Aetna provider survey released April 8.
    • “The survey will run quarterly, polling representatives of U.S. healthcare providers. This round fielded responses from 827 hospital system executives, physicians, nurses, pharmacists and health IT leaders over the first quarter of 2026. Global decision intelligence company Morning Consult conducted the survey.”

Monday report

David Ermer–ACA, CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–
  • Happy National Doctors’ Day!
    • “National Doctors’ Day is a nationwide observance dedicated to honoring physicians for their expertise, responsibility, and continued commitment to patient care. Observed annually on March 30, it creates a natural point of recognition for the role doctors play in the health and well-being of individuals, families, and communities, often during critical and life-changing moments.”

From Washington, DC.

  • Roll Call reports,
    • “President Donald Trump wants Congress to nix a two-week recess and return to the Capitol to address the ongoing Department of Homeland Security shutdown, his top spokesperson said Monday.
    • “The president is also encouraging Congress to come back to Washington to permanently fix this problem and to fund and reopen the Department of Homeland Security entirely,” White House press secretary Karoline Leavitt told reporters.”
  • Govexec adds,
    • “Most Transportation Security Administration officers received a paycheck Monday covering four weeks of back wages that were held up by the funding lapse at the Homeland Security Department, a TSA spokesperson said, [due to an Executive Order].
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM), in partnership with the White House, today announced the launch of a new Early Career Talent Network designed to connect emerging professionals with full-time career opportunities across the federal government.
    • “The new network, available at EarlyCareers.gov, will help build a stronger pipeline of talent into critical mission roles across government, including finance, human resources, engineering, project management, and procurement. The initiative supports broader administration efforts to modernize federal hiring and strengthen the next generation of public servants.
    •  “Building a strong pipeline of early-career talent is essential to the future of the federal workforce,” OPM Director Scott Kupor said. “We are making it easier for talented individuals to connect with meaningful careers in public service while helping agencies efficiently identify the talent they need to deliver results for the American people.”
  • OPM Director Scott Kupor made another management-oriented post to his Secrets of OPM blog now available on Substack. The post discusses the Earlycareers.gov initiative.
  • The American Hospital Association News tells us,
    • “Average out-of-pocket premiums for Health Insurance Marketplace enrollees increased $65 per month in 2026 compared to 2025, going from $113 to $178, according to a report released March 27 by the Centers for Medicare & Medicaid Services. The figures represent costs after accounting for the enhanced premium tax credits, which expired at the end of 2025. CMS also found that 40% of 2026 enrollees selected bronze plans, up from 30% in 2025. Silver plan selection dropped from 56% to 43%, while gold plan selection increased from 13% to 17%. Additionally, CMS said 23.1 million consumers selected or re-enrolled in Marketplace coverage for 2026, marking a 5% decrease from 2025.” 
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) today has chosen 15 scientific teams from across the nation as cash prize winners for their submissions to a national crowdsourcing challenge designed to generate innovative ideas that integrate diet and nutrition into autoimmune disease research. Winning submissions investigated the effectiveness of dietary interventions; microbiome, immune system and multi-omic approaches; personalized and data-driven predictive nutrition; and community and patient-center research frameworks. 
    • “Autoimmune diseases affect more than 8% of the U.S. population, impacting between 23 and 50 million Americans. Despite the prevalence and significant economic burden of autoimmune diseases, the role of diet and nutrition in this area remains largely underexplored. NIH invited researchers, clinicians, patients, caregivers, advocacy groups, and interdisciplinary teams to submit feasible, scalable approaches to better understand how dietary interventions may influence autoimmune disease onset, progression, flares, and symptom management. 
    • “The challenge, known as the Nutrition for Our Immune System Health (NOURISH): Autoimmunity Challenge and led by NIH’s Office of Autoimmune Disease Research, yielded many highly competitive submissions, and resulted in 15 prize awards, totaling $10,000 to each team. The winners showed thoughtful planning and designs that, with further development, could result in innovative solutions to benefit Americans affected by autoimmune diseases. Each winning entry contributed innovative, scientifically rigorous, and patient-centered ideas to advance the science of autoimmune disease research and care in one of four thematic areas.”
  • and
    • “The National Institutes of Health (NIH) announced that Elisabeth Armstrong, DBe, has been named chief of staff in the NIH Office of the Director.  As chief of staff, Dr. Armstrong will oversee the Office of the Director. She will provide strategic counsel to the NIH Director and other key leaders within NIH, in addition to managing process, operations, and information flows.    
    • “Dr. Armstrong is an outstanding addition to NIH’s leadership team. Her unique background and range of public and private sector experience will help drive positive action and innovation at NIH,” said NIH Director Jay Bhattacharya, M.D., Ph.D.” 

From the Food and Drug Administration front,

  • BioPharma Dive points out five FDA decisions to watch in the second quarter of 2026, which starts on Wednesday.
  • Per Fierce Pharma,
    • “With a second phase 3 win for Tyvaso in idiopathic pulmonary fibrosis (IPF), United Therapeutics is padding the case for an expansion and putting more color on its filing plans with the FDA. 
    • “In the wake of the “overwhelmingly positive” pair of late-stage readouts, multiple analysts are sharing in United’s optimism that Tyvaso (treprostinil) could change the treatment landscape in the lung scarring disease, which is estimated to affect more than 100,000 people in the U.S.” 
  • MedTech Dive reports,
    • “Medtronic has received 510(k) clearance for its Stealth AXiS surgical system for cranial and ear, nose and throat procedures.
    • “The clearances, which Medtronic disclosed Friday, expand the label of a system that combines surgical planning, navigation and robotics to improve surgeons’ workflows.
    • “Medtronic said cranial surgeons can use the system to create patient-specific brain maps, while the benefits for ENT teams include visualization tailored to the sinuses and skull base.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “A “highly mutated” COVID variant that flew under the radar for years has been detected in a growing number of U.S. states, health officials said this week.
    • “The Centers for Disease Control and Prevention (CDC) said in a March 19 report that it was tracking variant BA.3.2, nicknamed “Cicada,” after routine surveillance noted an increase in U.S. cases. The World Health Organization (WHO) likewise listed the strain on its “variants of monitoring” record, as it has been detected in at least 23 countries.
    • “Cicada still accounts for only a small number of cases in the United States, but has ballooned to represent up to 30% in some European countries. Still, the CDC said its monitoring of the spread “provides valuable information about the potential for this new SARS-CoV-2 lineage to evade immunity from a previous infection or vaccination.” * * *
    • “The CDC’s latest data from Feb. 11 used wastewater collected by its National Wastewater Surveillance System and Stanford University’s WastewaterSCAN Dashboard. A pathogen’s existence and prominence can be measured by testing wastewater samples collected from sources such as sewage, industrial waste and stormwater runoff.
    • “The testing tracked the presence of BA.3.2 in 25 states, including: California, Connecticut, Florida, Hawaii, Idaho, Illinois, Louisiana, Maine, Michigan, Maryland, Massachusetts, Missouri, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Vermont, Virginia and Wyoming.”
  • Stony Brook (NY) Medicine adds,
    • “The Cicada variant (BA.3.2) is a newer Omicron-related subvariant identified through global and U.S. monitoring systems. Like other recent strains, it has evolved with mutations that may influence how easily it spreads and how the immune system responds.” * * *
    • “Overall, while the Cicada variant may contribute to seasonal increases in cases, it does not currently appear to dramatically change the risk landscape.
    • “Health experts say that the BA.3.2 “Cicada” variant doesn’t seem to cause any new or unusual symptoms compared to other Omicron COVID‑19 variants. Right now, health organizations are mostly tracking how the virus spreads and changes, rather than listing new symptoms.”
  • The Wall Street Journal relates,
    • “Measuring cholesterol levels has long been the main way doctors assess the risk of heart disease. Increasingly, people are opting, too, for a simple, relatively affordable test: a coronary artery calcium scan, or CAC.
    • “The tests recently got a boost from influential clinical guidelines issued earlier this month by leading cardiology groups. These guidelines also included, for the first time, recommended levels of LDL—known as low-density lipoprotein or “bad” cholesterol—based on calcium scores from the scans.
    • “Why does this matter to you? The more calcium you have in your heart, the lower your LDL cholesterol should be to help reduce your risk of having a heart attack or stroke. So the scans give doctors and patients a more precise picture of your risk and whether you need to take action.”
  • The American Medical Association lets us know “what doctors wish patients knew about the deadly risk of stroke.”
    • “Every 40 seconds, someone in the U.S. has a stroke, which is a medical emergency that demands swift action. Meanwhile, every three minutes and 14 seconds, someone dies of stroke in this country. Stroke is the fifth leading cause of death in the U.S. and a major cause of long-term disability for adults, but it is preventable and treatable. That is why patients and families need to know more about preventing and identifying stroke. 
    • “More than 795,000 people in the U.S. have a stroke every year. About 610,000 of these are first or new strokes. Meanwhile, nearly 25% of strokes are in people who have had a previous stroke. And about 87% are ischemic strokes in which blood flow to the brain is blocked, according to the Centers for Disease Control and Prevention (CDC).”
  • Health Day tells us,
    • “For parents of a child with obesity, a normal lab report from the pediatrician may suggest that their weight isn’t yet a problem.
    • “But even if the child’s blood pressure is steady and their sugar levels are fine, those encouraging results — called metabolically healthy obesity or MHO — might be a deceptive snapshot of a much riskier future.
    • ‘Researchers at the Karolinska Institute in Sweden followed more than 7,200 children aged 7 to 17 who were in treatment for obesity. They were followed until age 30. 
    • “Over that period, researchers compared those with metabolically healthy test results to those with early warning signs, and to a control group of more than 35,000 from the general population.
    • ‘The study published March 23 in JAMA Pediatrics found that even kids with MHO — meaning they had normal blood pressure, liver values and blood fats — were at a disadvantage compared to their peers over the long term.”
  • CNN informs us,
    • “Calls to poison centers in the United States about the widely available herb kratom increased more than 1,200% between 2015 and 2025, new research has found.
    • “This data reflects a concerning trend,” study coauthor Dr. Christopher Holstege , director of the Blue Ridge Poison Center at the University of Virginia, said in a news release.
    • “The research was published Thursday in the US Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
    • “Kratom is an herb from the leaves of the tropical tree Mitragyna speciosa native to Southeast Asia. It has both stimulant and sedative effects and carries a risk of addiction due to how it interacts with the brain, Dr. Oliver Grundmann , a leading kratom researcher and clinical professor in the department of medicinal chemistry at the University of Florida, told CNN in an August story.
    • “The psychoactive herb isn’t federally regulated and thus isn’t “lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food,” according to the US Food and Drug Administration. But in states that haven’t banned kratom, it’s sold at gas stations, smoke shops and convenience, grocery and health food stores in various forms, including powders, loose-leaf teas, capsules, tablets and concentrates. Some states allow people of any age to buy it.”
  • Neurology Advisor notes,
    • “Among multiple healthy dietary patterns, higher adherence to the DASH diet was associated with the greatest reduction in risk for subjective cognitive decline, supporting diet quality as a modifiable factor for cognitive health.”
  • Per Fierce Pharma,
    • “After notching a phase 2 trial win, Idorsia’s insomnia med Quviviq (daridorexant) is one step closer to potentially becoming a first-in-class treatment for children.
    • “The drug, a dual orexin receptor antagonist (DORA), was studied in children with insomnia between the ages of 10 and 17 years old, including those with neurodevelopmental disorders such as autism spectrum disorder and attention-deficit/hyperactivity disorder (ADHD). 
    • “As measured through a two-week polysomnography sleep study, 165 patients who received a 10-, 25- or 50-mg dose of Quviviq experienced dose-dependent improvements in total sleep time from baseline, Idorsia reported on Monday.”
  • Per MedTech Dive,
    • “Boston Scientific’s Watchman FLX left atrial appendage closure device worked as effectively as blood thinners to lower stroke risk and death at three years in patients with non-valvular atrial fibrillation, study data unveiled Saturday showed.
    • “The study also demonstrated a 45% relative reduction in non-procedural bleeding risk in patients who received the Watchman FLX implant. The findings of the closely watched CHAMPION-AF clinical trial were presented at the American College of Cardiology’s annual meeting and published in the New England Journal of Medicine.
    • “The 3,000-patient study met all of its safety and efficacy endpoints. Boston Scientific said it will seek to expand the indication and Medicare coverage for the device as a first-line stroke risk reduction option based on the results.

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

  • Beckers Hospital Review reports,
    • “Cigna’s Express Scripts continued its lead in the U.S. pharmacy benefit manager market for the second year in a row, processing nearly one-third of all prescription claims, according to a March 30 report from the Drug Channels Institute.
    • “The PBM handled 31% of total equivalent prescription claims last year, up from 30% in 2024. CVS Caremark, which dominated the sector until 2024, saw its share fall to 26% amid volume losses tied to major client transitions. Optum Rx, a subsidiary of UnitedHealth Group, maintained a 23% share for the second straight year.
    • “Despite ongoing scrutiny from regulators and rising competition from smaller firms, the same three PBMs as last year still control 80% of the market.
    • “The rankings are based on Drug Channels Institute’s analysis of total equivalent prescription claims processed across the industry.”
  • and
    • “CVS Pharmacy will open its first pharmacy-only location in Chicago on March 30.
    • “The store, located at 2628 W. Pershing Road in the city’s West End, is part of a planned rollout of nearly 20 pharmacy-only, apothecary-style CVS Pharmacy locations expected to launch in select communities in 2026, according to a March 24 statement from CVS shared with Becker’s. The format reflects CVS’ shift toward smaller, pharmacy-focused stores amid declining retail sales.
    • “CVS is in the early stages of launching the new model, the first locations under which will average less than 5,000 square feet — about half the size of a traditional CVS store. The sites will stock health-related products but exclude general consumer goods like greeting cards and groceries.
    • “The launch comes as CVS repositions its pharmacy footprint. The company closed 270 locations in 2025 but plans to open nearly 100 new sites, including more than 60 acquired from Rite-Aid. According to CVS Health’s October 2025 “Rx Report,” 80% of patients prefer in-person pharmacy care and 84% view pharmacies as credible sources of healthcare. The small-format stores aim to meet these expectations while expanding access in underserved areas.”
  • BioPharma Dive relates,
    • “Obesity drugmaker Kailera Therapeutics plans to test investor appetites for another biotechnology initial public offering, according to a Friday securities filing.
    • “If successful, the company, which has several experimental weight loss medicines in testing, could join a short list of newly public biotechs that have raised more than $1.7 billion in proceeds so far this year.
    • “Kailera’s most advanced prospect, ribupatide, is a weekly GLP-1/GIP agonist in late-stage testing. So far, Kailera and its partner Hengrui Pharma have published data from a 48-week Phase 3 trial in Chinashowing that ribupatide helped people with obesity, on average, lose 18% of their body weight.
    • “The drugmaker expects to publish data from an earlier study of an increased dose next year, and findings from its global Phase 3 study in 2028.”
  • A MedCity News opinion piece explains why
    • “AI Can Expand Access to Healthcare — But Only With Human Action
    • “Health systems can turn insights into action, ensuring that preventive care actually happens by combining accurate risk prediction with human outreach and careful planning.”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of lorundrostat (Mineralys Therapeutics, Inc.) and baxdrostat (AstraZeneca) for hypertension.
    • “The assessment will be publicly discussed during a meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in October 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
    • “Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including relevant patient groups, the manufacturers, and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.  
    • “All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to publiccomments@icer.org and must be received by 5 PM ET on April 17, 2026.”

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, HSA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “President Trump directed federal officials to pay Transportation Security Administration workers, bypassing a gridlocked Congress after the latest proposal to fund the broader Department of Homeland Security ran aground Friday.
    • “The move, which Trump had previewed a day earlier, came as House Republican leaders rejected a Senate-passed bill that would fund most of DHS, including the TSA. A standoff in Congress over immigration enforcement and funding has led to missed paychecks for airport-security workers and long lines for travelers.
    • “The executive action instructs the Homeland Security secretary and the White House budget director to use federal funds that have a “reasonable and logical nexus to TSA operations” to pay the TSA workers. The memo, signed Friday afternoon by Trump, described the situation at the airports as an “unprecedented emergency.”
    • “TSA officers should begin getting paychecks as early as Monday, DHS said.”
  • STAT News tells us,
    • “The White House has drafted legislative text for its drug pricing policy, and officials are in the process of sharing it with more than a dozen major pharmaceutical companies, according to people familiar with the meetings.
    • “The legislative text, according to a White House official, closely follows the outlines of the voluntary deals the administration made with pharma companies. The draft includes a policy that would allow drugs purchased in cash to count toward a patient’s deductible.
    • “The Trump administration’s push for drug price legislation is part of a larger effortto get health reforms signed into law. The president’s focus on his affordability agenda in an election year has heightened the profile of the effort.
    • “Still, despite the White House digging in to get Congress to pass its plan, lawmakers have little appetite for major changes — and there’s no clear path to passage.”
  • The AP relates,
    • “Vice President JD Vance on Friday held the inaugural meeting of a new anti-fraud task force he’s leading as the Trump administration seeks to show it’s cracking down on potential misuse of social programs.
    • “Vance, speaking Friday before the task force held a closed-door meeting, said that the federal government, for decades, had not taken the issue of fraud seriously and that it needed to be tackled with “a whole-government approach.”
    • “This is not just the theft of the American people’s money,” Vance said. “It is also the theft of critical services that the American people rely on.” * * *
    • “Joining the task force was Colin McDonald, a top aide to the Justice Department’s second in command. He was recently confirmed as the assistant attorney general overseeing the department’s new division focused on prosecuting fraud.”
  • The American Hospital Association News informs us,
    • “The Substance Abuse and Mental Health Services Administration has released an advisory examining innovative solutions to close gaps in behavioral health care deserts. It highlights how more than 60% of rural Americans live in designated behavioral health shortage areas. The advisory details how integrating additional community health workers and peer support specialists can enhance care. It also explains the strengths of both and includes strategies for recruitment and retention.” 

From the Food and Drug Administration front,

  • STAT News reports,
    • “Food and Drug Administration officials briefed senators on the agency’s plans for food policy for 2026, according to a person familiar with the meeting.
    • “The agency plans to focus on infant formula safety, updating food labels, defining ultra-processed foods, expanding inspections of food processing plants, and bolstering seafood safety programs, according to a document shared with lawmakers, obtained by STAT.
    • “The meeting comes amid a shift in the administration’s health agenda toward food issues and away from vaccine policy. In recent polls, food reforms have been more popular than the vaccine agenda, catching the attention of administration officials looking to sharpen their message for the midterms.”
  • Fierce Pharma relates,
    • “The FDA signed off on a new insulin from Novo Nordisk, marking the U.S.’s first once-weekly basil insulin for adults with Type 2 diabetes. 
    • “Novo’s Awiqli offers a new long-acting option compared to standard daily basil insulin injections, representing an “important advancement that meets a real need,” the company’s VP of clinical development, medical and regulatory affairs, Anna Windle, Ph.D., commented in a release. 
    • “The FDA based its decision on Novo’s Onwards Type 2 diabetes phase 3a clinical trial program, which consisted of four randomized, active-controlled, treat-to-target trials that enrolled 2,680 adults with uncontrolled Type 2 diabetes. The studies showed that once-weekly Awiqli achieved efficacy in reducing A1C over daily basal insulin, with a safety profile consistent with the daily basal insulin class. 
    • “Awiqli is administered using Novo’s FlexTouch pen and will be available across the country in “the coming months,” the company said.”
  • MedTech Dive tells us,
    • “Philips said Thursday it has received 510(k) clearance for a heart procedure visualization tool it developed with Edwards Lifesciences.
    • “The system, called EchoNavigator R5.0 with DeviceGuide, uses artificial intelligence to enable surgeons to track and visualize mitral valve repair devices during minimally invasive heart procedures. 
    • “Philips said the system is intended for use with Edwards’ Pascal Ace mitral valve repair system, which competes with Abbott’s MitraClip for the transcatheter edge-to-edge repair market.”
  • MedPage Today informs us,
    • “The FDA on Thursday granted accelerated approval to marnetegragene autotemcel (Kresladi) as the first gene therapy for treating kids with severe leukocyte adhesion deficiency type I (LAD-I), an ultra-rare inherited immune deficiency.
    • “Approval stipulates use in LAD-I cases caused by biallelic variants in the ITGB2 gene and in which no human leukocyte antigen (HLA)-matched sibling donor is available for allogeneic hematopoietic stem cell transplant.
    • “LAD-I has an estimated incidence of 1 per 100,000-200,000 live births, and the disorder brings substantial morbidity and mortality in a child’s first decade of life. Roughly two-thirds of patients have the severe form of the disease, which is characterized by recurrent, life-threatening infections that don’t respond well to antimicrobials and time spent in and out of hospitals.”

From the public health and medical/Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “After a tough flu season, today’s respiratory virus update from the Centers for Disease Control and Prevention (CDC) offers a bit of good news: Doctors are seeing fewer people with influenza.
    • “Cases of flu are declining in most of the country. While influenza A is on its way out, rates of influenza B—which tends to peak later in flu season—vary by region. Levels of influenza A in wastewater are low. Influenza B is not monitored in wastewater.
    • “Most flu viruses reported this week were influenza A(H3N2) and influenza B. Nearly 93% of influenza A(H3N2) viruses since late September belong to subclade K, a new strain that was not included in this year’s flu shots.
    • “About 5,640 people were admitted to the hospital for flu in the past week, nearly 2,000 fewer than the previous week, according to the CDC’s FluView report. Eight additional flu deaths were reported in children, bringing the total number for this season to 123. Among children who were eligible for a flu shot and whose vaccination status is known, 85% of children who died from flu were not fully vaccinated.
    • “The CDC estimates that there have been at least 29 million illnesses, 360,000 hospitalizations, and 23,000 deaths from flu so far this season.
    • “Although respiratory syncytial virus (RSV) levels remain high, the country seems to have gotten past the worst of RSV season, which has peaked in many regions of the nation. Levels of RSV in wastewater are low.
    • “The number of COVID-19 infections is low, with low levels in wastewater. Although COVID-related emergency room visits remain low across the country, they are likely increasing in Florida and Massachusetts. According to the CDC, 2.3% of tests for COVID-19 were positive, along with 7.5% for RSV and 11.5% for the flu.”
  • The American Hospital Association News relates,
    • “A measles outbreak in Utah is now at 486 cases, with 107 reported in the last three weeks, according to datafrom the state’s Department of Health and Human Services. The outbreak began in June 2025. Nationally, 1,575 measles cases have been reported so far this year to the Centers for Disease Control and Prevention. A South Carolina measles outbreak, which began in October 2025, remains at 997 cases, the state’s Department of Public Health reported today. No new cases have been reported by the state since March 17.” 
  • and
    • “The Centers for Disease Control and Prevention March 26 released a report on U.S. child vaccination coverage by age 2. The report found that coverage among children born from 2021-2022 was similar to those born in 2019-2020 but noted decreases for five vaccines. The CDC found declines in vaccinations for the flu (7.4 percentage points), the birth dose of the hepatitis B vaccine (1.8 percentage points), rotavirus (1.7 percentage points), the pneumococcal conjugate vaccine (1.5 percentage points) and the primary series of the Haemophilus influenzae type b conjugate vaccine (1 percentage point). The report also found that coverage varied by race and ethnicity, poverty status, urbanicity and jurisdiction. 
    • “Vaccines have substantially reduced severe illness, hospitalization, and death and have saved approximately $2.7 trillion in societal costs,” the CDC wrote. “Although national vaccination coverage remained stable for most vaccines, lower coverage among certain population subgroups and in some jurisdictions is creating an increased risk for outbreaks of vaccine-preventable diseases.” 
  • The Washington Post identifies “13 surprising ways GLP-1s may benefit the body, according to science.”
  • Beckers Hospital Review points out four ways GLP-1s are changing care patterns, patient behavior
  • Medscape adds,
    • “When individuals with overweight or obesity discontinue GLP-1 receptor agonists (RAs), they regain approximately 60% of their weight within 1 year following GLP-1 RA discontinuation.
    • “Approximately 25% of the weight loss achieved with these medications appears to persist with long-term findings, with significant implications for how clinicians counsel patients at the point of discontinuation.
    • “These are the two central findings of a meta-analysis of 48 studies, including 36 randomized controlled trials, conducted by British researchers led by medical students Brajan Budini and Steven Luo from the School of Clinical Medicine, University of Cambridge, Cambridge, England. The results were published in eClinical Medicine, which is a part of The Lancet Discovery Science.
  • MedPage Today tells us,
    • “While mammography use did not significantly decline overall from 2002 to 2022, there was a significant drop in certain subgroups.
    • “Declines were significant among young women without health insurance, current smokers, unmarried women, and white women.
    • “The prevalence of mammography use among women ages 40-49 fell by almost 10 percentage points from 2010 to 2022 following guideline changes.”
  • Helio informs us,
    • “Global early-onset cancer incidence has risen slightly since 1990, but mortality has decreased significantly.
    • “Deaths related to obesity have gone up substantially in the past 3 decades.”
  • Per BioPharma Dive,
    • “AstraZeneca said Friday its experimental antibody drug tozorakimab met its main goal in two Phase 3 trials in chronic obstructive pulmonary disease, helping reduce flare-ups in a broad range of people with the condition.
    • “The data could help AstraZeneca’s drug reach more patients than the currently available biologics for COPD, Dupixent and Nucala, both of which are limited to those with high levels of white blood cells called eosinophils. The U.K.-based drugmaker said the trials “included former and current smokers, and patients across all blood eosinophil counts and all stages of lung function severity.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “One or two health systems controlled the entire inpatient hospital care market in 47% of metropolitan areas in 2024, a March 27 KFF Health News report found.”
  • Fierce Healthcare relates,
    • “A new oral GLP-1 therapy and the first preventive option for COVID-19 are among the pipeline drugs that payers and plan sponsors should be watching this spring, according to a new report.
    • “The pipeline surveillance team at Optum Rx has released its latest report on notable drugs that are set for an imminent Food and Drug Administration review. The spring edition includes:
    • Icotyde, or icotrokinra, an oral therapy for moderate-to-severe plaque psoriasis that secured FDA approval in March.
      • “Orforglipron, the second oral GLP-1 treatment, which is set for an April review.
      • “Ensitrelvir, or Xocova, a preventative therapy for COVID-19 exposure, with an FDA decision expected in June.
    • “Icotyde and orforglipron both fit within high-priority areas for many insurers: psoriasis and obesity. In the latter case, it would follow an oral Wegovy to market, but orflorglipron is the first oral GLP-1 that does not have meal-time restrictions.”
  • Lively shares its 2026 healthcare savings account spend report.
    • Healthcare is changing — and HSA spending tells the story.
    • In 2025, where and how people use their health savings accounts (HSAs) reveals a clear shift.
    • Consumers are no longer relying solely on hospitals and traditional providers. They are increasingly turning to retail brands, digital platforms, direct-to-consumer healthcare companies, and connected health technology.
    • HSAs are evolving from long-term savings tools into active, everyday healthcare wallets.
  • Fierce Pharma tells us,
    • “New drug manufacturer Neion Bio has emerged from stealth after incubating a novel way to cook up biologic drugs. After its founding two years ago, the company is cracking open a multi-product commercial biosimilar partnership with an unnamed drugmaker.
    • “Using its Raptor platform to produce recombinant biologics in eggs, the company is teaming up with an unnamed pharma company to co-develop and supply up to three monoclonal antibodies in a deal that includes upfront and milestone payments, plus profit sharing upon potential commercialization. 
    • “Neion Bio’s platform removes the capital intensity and process constraints of traditional biomanufacturing, enabling highly scalable and resilient production while materially lowering the cost of development and supply,” CEO and co-founder Dimi Kellari said in a company release.”
  • BioPharma Dive informs us,
    • “One of the largest drug companies in Japan is looking to, through a $700 million buyout, take control of an experimental medicine that could be useful for treating post-traumatic stress disorder and other psychiatric conditions.
    • “On Friday, Otsuka Pharmaceutical announced that its American subsidiary plans to acquire privately held, New York-based Transcend Therapeutics. In addition to the upfront payment, Otsuka offered up to $525 million more if Transcend’s assets ultimately hit certain sales milestones. The companies expect to complete their deal sometime between April and the end of June.
    • “If finalized, the acquisition would hand Otsuka a drug meant to rapidly restore and improve “neuroplasticity,” or the brain’s ability to rewire and adjust the connections between neurons. Neuroplasticity impairment is a fundamental component of many psychiatric conditions — including PTSD, where chronic stress and trauma can keep brain cell networks stuck in a fear-based survival mode.
    • “The active ingredient in Transcend’s “TSND-201” is methylone, an analog of MDMA that was first synthesized three decades ago and widely used as a “designer drug.”  TSND-201 engages with certain transporter proteins that regulate neurotransmitters like serotonin, norepinephrine and dopamine, which, according to Transcend, results in “rapid and sustained enhancement of neuroplasticity.”
  • and
    • “Novartis will acquire Excellergy, a young allergy drugmaker, to gain access to an experimental therapy that could improve upon the widely used medication Xolair. 
    • “The deal announced Friday could be worth as much as $2 billion overall when including the unspecified upfront payment as well as future payouts. It’s expected to close in the second half of the year, the companies said in a statement.
    • “At the heart of the acquisition is a drug called Exl-111, which targets the antibody immunoglobulin E, or IgE. In certain cases, IgE can mistakenly react to substances — like food, pollen or pet dander — that wouldn’t otherwise be harmful. The antibody then binds to cells, triggering the release of histamines and in turn, an allergic reaction.” * * *
    • “It’s the holy grail of what people are trying to accomplish,” Geoff Harris, Excellergy’s chief scientific officer, told BioPharma Dive in October. “If you can turn off this access to the immune system, you can completely control a wide swath of different allergy-driven diseases.”

Thursday report

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

From Washington, DC,

  • Roll Call reports,
    • “President Donald Trump announced Thursday night he would immediately begin paying Transportation Security Administration workers through an emergency executive order.
    • “The order promised to end long delays at the nation’s airports and allow TSA workers to get paychecks they have been denied during a partial shutdown of the Department of Homeland Security that has persisted for more than 40 days. 
    • “It also offered a partial reprieve for Congress, which has been locked in a bitter partisan standoff over immigration enforcement policies that has kept the department unfunded for weeks. Long lines at airport checkpoints and complaints from TSA workers had become critical pressure points in a search for an end to the shutdown.”
  • Per a White House fact sheet,
    • Today, President Donald J. Trump signed an Executive Order eliminating racially discriminatory “diversity, equity, and inclusion” (DEI) practices by Federal contractors and their subcontractors, ensuring merit-based and efficient contracting and employment.
      • The Order requires that all Federal contracts that are subject to the Federal Property and Administrative Services Act include a clause prohibiting contractors and their subcontractors from engaging in racially discriminatory DEI activities.
      • The Order directs the Office of Management and Budget to issue guidance to contracting agencies to ensure compliance and identify economic sectors that pose a particular risk of engaging in racially discriminatory DEI activities.
      • The Order authorizes contracting agencies to cancel, terminate, or suspend contracts — and to suspend or debar contractors — for failure to comply.
      • The Order directs the Attorney General to prioritize potential claims under the False Claims Act against contractors or subcontractors that are in violation of the contractual terms prohibiting racially discriminatory DEI activities, and ensure the prompt review of related civil actions brought by private persons.
      • The Order directs the Federal Acquisition Regulatory Council to amend Federal Acquisition Regulations to include this clause and remove any conflicting provisions.  
  • Per a CMS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) announced the members of the Healthcare Advisory Committee, a new federal advisory body comprised of leaders from across the healthcare system to provide expert advice on improving, strengthening and modernizing U.S. healthcare.
    • “The Committee will advise HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz on ways to improve how care is financed and delivered across Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace.
    • “This Administration is bringing leaders together to tackle the challenges facing American patients and the health care system, putting prevention front and center,” said HHS Secretary Robert F. Kennedy, Jr. “This committee will help us shift from a sick care system to a true health care system by delivering practical solutions that drive real change.”
    • “We received an overwhelming response from highly qualified candidates across the country,” said CMS Administrator Dr. Mehmet Oz. “These members bring deep expertise across care delivery, financing, innovation, and patient engagement. Their insights will help us advance higher-quality care, reduce administrative burden, and strengthen the sustainability of our programs, while supporting efforts to transform our healthcare system and restore a stronger focus on patients.” * * *
    • “The Committee will convene its first meeting later this year. Additional information, including meeting notices and opportunities for public engagement, will be published in the Federal Register and on the CMS website.
    • “For more information, visit: www.cms.gov/priorities/healthcare-advisory-committee/overview“
  • Federal News Network tells us,
    • “Thrift Savings Plan participation is at an all-time high — and nearly 90% of Federal Employee Retirement System (FERS) participants are contributing enough to receive a full match from the government. The TSP board is also reporting that participant satisfaction with the agency’s customer service center is at nearly 94%. Satisfaction scores have remained at that level, now for more than a year. (Federal Retirement Thrift Investment Board – TSP monthly report, March 2026)”

From the judicial front,

  • Bloomberg Law reports,
    • “The government can lawfully limit federal health carriers from covering certain gender transition procedures, the EEOC said in a new ruling.
    • “The Republican-controlled commission on Thursday rejected claims from a group of transgender current and former federal employees that the Office of Personnel Management’s health coverage policy violated anti-discrimination laws. 
    • “The ruling in Sam T. v. Kupor adds to the Equal Employment Opportunity Commission’s efforts under the Trump administration to chip away at transgender rights in the private and federal sectors.”
  • An OPM news release adds,
    • “The EEOC’s landmark ruling reinforces OPM’s duty to manage the FEHB Program responsibly and protect taxpayer-funded benefits for federal employees and retirees,” Associate Director for Healthcare and Insurance Shane Stevens said. “Federal health benefits must be administered in a way that is fiscally responsible, legally sound, delivers high-quality care, and works toward improved health outcomes.”
  • The next step for this lawsuit is federal district court.
  • The Wall Street Journal relates,
    • “The Justice Department filed an antitrust lawsuit against the prominent hospital system NewYork-Presbyterian, alleging that it used restrictions in its contracts with insurers to limit price competition and block lower-cost healthcare options.
    • “The suit, first reported by The Wall Street Journal, was filed Thursday in the U.S. District Court for the Southern District of New York. It is the latest development in a broader Justice Department effort focused on whether hospital systems use hidden contracts to protect their market position and maintain high prices.”

From the public health and medical / Rx research front.

  • The American Hospital Association News reports,
    • “An American Heart Association study published March 25 found that children born to mothers with premature placental separation could be at higher risk of heart disease by age 28. They also are nearly three times more likely to be hospitalized for heart-related complications, such as heart failure, ischemic heart disease, heart attack, blocked arteries or general cardiovascular disease. The study examined nearly three million pregnancies and found that approximately 1% were impacted by placental abruption. Although limited in scope and not focused on interventions, the study highlights the importance of postpartum and postnatal monitoring for maternal and infant complications.” 
  • The Washington Post points out “five things you need to know about meningitis.”
    • “Two people died in an outbreak of bacterial meningitis in England. The infection, which is rare, requires prompt medical treatment to avoid severe complications.”
  • MedPage Today tells us,
    • “After peaking at over 185,000 courses in 2015, prescriptions for direct-acting antivirals (DAAs) for hepatitis C virus infections dropped 63% by 2025.
    • “While those older than 61 years accounted for over 40% of DAA-treated patients in 2015, that percentage shrank to roughly 25% by 2025.
    • “Specialists wrote two-thirds of DAA prescriptions in 2015, but their share fell to 28% by 2025.” * * *
    • “These are “sobering numbers” that reflect the need for a national HCV elimination plan such as the Cure Hepatitis C Act of 2025, Debika Bhattacharya, MD, of the University of California Los Angeles, told MedPage Today. “We must expand access to DAAs.”
  • and
    • “Patients with a history of depression or anxiety were less likely to see their mental health decline while on GLP-1 medications.
    • “The link between GLP-1 drug use and lower risk of psychiatric decline was more pronounced for semaglutide than for other agents.
    • “The data may allay prior concerns about suicidality, which prompted an FDA investigation in 2023.”
  • and
    • “Alzheimer’s can be detected early with p-tau blood biomarkers, but some tests can lead to overdiagnosis.
    • “Combining p-tau217 and eMTBR-tau243 may refine diagnostic accuracy and reduce false-positives.
    • “Plasma eMTBR-tau243 also could help identify people with high tau burden.”
  • NPR adds,
    • “Babies under 6 months old still have one of the highest rates of hospitalization from COVID-19 infections compared to other age groups, but no COVID vaccine is available for these infants.
    • “That’s one reason the American College of Obstetricians and Gynecologists, or ACOG, recommends COVID vaccination during pregnancy.
    • “There are a number of studies that show one of the benefits of COVID vaccination during pregnancy is the passage of antibodies to the newborn, and then that protects the newborn against COVID,” says Dr. Kevin Ault, a professor of obstetrics and gynecology at Western Michigan University Homer Stryker M.D. School of Medicine in Kalamazoo, Mich.”

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

  • MedCity News reports,
    • “Affordability is top of mind for executives at AHIP as Americans battle skyrocketing healthcare costs.
    • “We are laser-focused on affordability at AHIP,” said Mike Tuffin, president and CEO of AHIP. “That’s, of course, the issue at every kitchen table. … We see the cost of hospital care, certainly the cost of brand prescription drugs, specialty care, imaging, down the line, just continuing to rise faster than wages, faster than inflation. That’s driving up premiums across all markets. Premiums directly reflect the underlying cost of medical care.”
    • “Tuffin made these comments during a press briefing on Tuesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. AHIP is an advocacy organization for health insurers.
    • “As for what’s leading to the rising cost of care, Tuffin pointed the finger at hospital consolidation, as well as actions by drug manufacturers like patent thickets (in which there is a dense web of multiple patents around one medication). 
    • “Tuffin added that AHIP is focused on improving affordability across four zones:
      • “More competition, especially for prescription drugs, and addressing hospital consolidation
      • “Site of service reforms, and increasingly using the home as a site of service. According to Tuffin, too much care is delivered at the costliest sites of care, like the emergency room
      • “Tackling administrative burden, as the healthcare system is still “far too dependent on fax machines”
      • “Aligning incentives around patient care outcomes and driving value across the system.”
  • The Wall Street Journal assesses the “Weight Loss Drug Frenzy: What’s Here and What’s Likely Coming Next.”
    • “The market for weight loss drugs is exploding and patients may have several new options in coming years.”
  • Beckers Payer Issues relates,
    • “Centene has named Kate Casso senior vice president of finance operations and innovation and Theodore Pienkos corporate controller and chief accounting officer.
    • “Ms. Casso has been with Centene for more than two decades and has served as the company’s corporate controller and chief accounting officer since April 2021, according to a March 24 regulatory filing. 
    • “Ms. Casso will focus in part on enterprise and finance innovation while continuing to lead data analytics, medical economics, payment integrity, finance shared services and financial planning and analysis. 
    • “Mr. Pienkos has been with Centene since 2011 and has served as the company’s deputy corporate controller since August 2024. He previously served as vice president of finance and accounting.
    • “Both appointments were effective March 18.”
  • BioPharma Dive informs us,
    • “Merck’s deal for Terns [mentioned in yesterday’s FEHBlog post] sparks debate over a possible biotech bidding war
    • “Some analysts argue the $6.7 billion offer undervalues biotech’s lead cancer drug, although investors may be happy with one-year returns.”
  • and
    • “Shares of Maze Therapeutics, a San Francisco-area biotechnology company, fell over 30% Wednesday despite positive clinical trial results for a progressive kidney disease drug that could potentially compete with a rival therapy from Vertex Pharmaceuticals.
    • “Maze said that, in a mid-stage trial, treatment with its experimental drug, “MZE829,” led to a “clinically meaningful” reduction of protein levels in urine by an average of almost 36% in people with a kidney disease caused by mutations in a gene called APOL1. Maze said it will continue enrollment for its Phase 2 trial and plans to meet with regulators to advance MZE829 into pivotal testing for AMKD, or APOL1-mediated kidney disease.
    • “Full results from the Phase 2 trial will be presented at a future medical conference, Maze added.”
  • Beckers Payer Issues informs us that “UnitedHealthcare has launched Avery, a generative AI companion that helps members navigate healthcare services.”
  • Health Exec adds,
    • “U.S. patients wait an average 31 days to see a doctor, so it’s no wonder 65% of surveyed consumers have consulted AI specifically because it’s faster and easier.
    • “Meanwhile 77% of clinicians appreciate the technology’s contributions to healthcare—yet 1 in 5 patients have tried to hide their use of AI from their doctors. 
    • “Most who admit to the secrecy chalk it up to a fear of being judged. 
    • “The findings are from a survey report released March 24 by Zocdoc, a digital appointment-booking service that has markedly increased its use of AI.”
  • Fierce Healthcare notes,
    • “OpenEvidence released an artificial intelligence-powered medical coding feature embedded in its clinical AI assistant.
    • “The new feature, called Coding Intelligence, provides automatic Current Procedural Terminology (CPT) code suggestions, evaluation and management (E/M) level recommendations with supporting medical decision-making rationale written directly into the note and ICD-10 diagnoses, according to the company.
    • “The tool, available in OpenEvidence Visits, provides coding derived from the clinical documentation and it automatically applies at the end of every doctor-patient visit, executives said.
    • “Without any extra work, OpenEvidence is able to generate concise rationale for their CPT + E/M suggestions. It truly captures the complexity of the encounter and saves me hours when I’m at the ER,” said Ania Bilski, M.D., vice president of clinical AI at OpenEvidence.”