Monday Report

Obesity

Monday Report

David Ermer–ACA, CMS, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NIH, Obesity, U.S. Healthcare–

Simplicity is a virtue.

“In her 1789 book The Female Reader, writer and philosopher Mary Wollstonecraft wrote: “Simplicity and sincerity generally go hand in hand, as both proceed from a love of truth.” (Source: https://tinyurl.com/4fzesrp4)

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. launched GetActive.gov, a new national resource to help Americans improve their health through movement, fitness, outdoor recreation, and active living, during a series of “Take Back Your Health” tour stops across Colorado.
    • “Secretary Kennedy joined Secretary of the Interior Doug Burgum in Grand Junction to announce the initiative and highlight the Trump Administration’s efforts to expand access to public lands and outdoor recreation opportunities. He then visited Fort Carson to see firsthand how the Army is improving nutrition for servicemembers through its campus-style dining modernization program. The Secretary also toured InnovAge in Thornton, where he met with caregivers and seniors participating in the Program of All-Inclusive Care for the Elderly (PACE).
    • “The key to reversing America’s chronic disease epidemic is empowering people to take back their health,” Secretary Kennedy said. “We are helping people Get Active, Eat Real Food, and Live Real Life. From our public lands to our military bases to our senior care centers, these Colorado visits show how we are putting Make America Healthy Again into action.”
  • The American Hospital Association News reports,
    • “The Medicaid and CHIP Payment and Access Commission June 15 released its June 2026 report to Congress. Among the topics discussed, chapter two focuses on automation in Medicaid prior authorization and makes recommendations to improve oversight and increase disclosure and transparency of managed care plans’ use of automation in PA. The third chapter includes recommendations to improve managed care plan accountability. Chapter seven examines Medicaid provider enrollment and managed care credentialing processes and highlights challenges that have effects on provider participation and state administrative burden.”
  • and
    • “The Centers for Medicare & Medicaid Services and the Department of Health and Human Services issued a request for information June 12 seeking input on CMS’ review of the Affordable Care Act’s Essential Health Benefits framework and the requirement that the scope of EHBs is equal to the scope of benefits provided under a standard employer plan. Specifically, CMS is seeking comments on current interpretations of EHBs, state approaches to selecting and updating EHB-benchmark plans, methodologies to determine the scope of benefits included as EHBs, and how those approaches relate to access and market stability under the ACA. The agencies said the information will impact CMS’ evaluation on whether revisions or additions to current EHB regulations would be appropriate. Comments are due by July 15.”
  • BioPharma Dive relates,
    • “New under-the-skin injections of the cancer immunotherapies Keytruda and Opdivo would be subject to Medicare price negotiations at the same time as their intravenous counterparts under a proposed federal rule published Friday.
    • “The Centers for Medicare and Medicaid Services said the rule would close a “loophole” that allows drugmakers to extend the patent-protected life of blockbuster drugs, commonly called “evergreening.” However, Medicare could exempt the newer formulation from its price ceiling should biosimilars of the IV version enter the market and compete on price.
    • “The rule could most immediately affect Keytruda maker Merck & Co. and Opdivo developer Bristol Myers Squibb, along with Halozyme, which developed the delivery technology that helped Opdivo and Johnson & Johnson’s Darzalex transition from IV to subcutaneous shots. Halozyme, however, said it forecasts “zero to minimal impact to its royalty revenues through at least 2035.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration said Monday that it will allow Colorado to import certain prescription drugs from Canada in an effort to bring prices down for residents, making it the second U.S. state to be granted such authorization. 
    • “For more than a quarter of a century, Americans have sought drugs from Canada for relief from the ever-rising costs of medicines, sometimes taking widely publicized bus trips across the border. It wasn’t until 2020, though, that the first Trump administration officially endorsed the practice, when it published a regulationallowing states and Indian tribes to propose import plans. The Biden administration affirmed this rule with an executive order in 2021. And Florida became the first state to earn FDA approval in 2024. 
    • “But state importation programs have proved extremely difficult to carry out, even with bipartisan support. Florida has yet to actually import any drugs from Canada, in part due to pushback from the Canadian pharmaceutical industry and fears the program will affect Canada’s drug supply. In May, the FDA extended its approval by six months to give the state more time to get its program up and running.”
  • Fierce Pharma relates,
    • “Despite prior concerns from the FDA, a regimen involving AstraZeneca’s AKT inhibitor Truqap (capivasertib) has passed muster in a specific population of prostate cancer patients. 
    • “Late last week, the U.S. regulator signed off on Truqap plus Johnson & Johnson’s Zytiga (abiraterone) and prednisone to treat adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer—the indication previously known as metastatic hormone-sensitive prostate cancer—that is determined to be PTEN-deficient.
  • and
    • Merck & Co.’s first-in-class HIF-2 alpha inhibitor Welireg is touching down in the clear cell renal cell carcinoma (ccRCC) treatment space, notching a Keytruda combination nod that stands to pad the landing for the company’s post-Keytruda outlook. 
    • The June 12 FDA approval is the first for a PD-1 and HIF-2a inhibitor combo, stipulating the regimen’s use as an adjuvant treatment for adults with ccRCC who are at intermediate-high or high risk of recurrence following kidney removal surgery. Welireg can be used in the disease setting with standard Keytruda or subcutaneous Keytruda Qlex. 
    • With that, Welireg can reach earlier-stage ccRCC for the first time following its 2023 clearance in advanced RCC, marking an “important step in addressing the needs of patients with earlier-stage renal cell carcinoma,” kidney cancer advocacy group KidneyCan’s CEO and co-founder Bryan Lewis noted in a Merck press release. 
  • Cardiovascular Busines tells us,
    • “Penumbra, a California-based medtech company known for its vascular technologies, has received U.S. Food and Drug Administration (FDA) clearance for a new computer-assisted vacuum thrombectomy (CAVT) device designed to treat acute ischemic stroke.
    • “According to Penumbra, Thunderbolt represents the first CAVT device approved in the United States for the treatment of stroke. It is powered by Penumbra’s Engine technology and uses modulated aspiration to “detect, fatigue and completely ingest” blood clots at the site of occlusion. Thunderbolt will be sent to customers prepackaged with one of the company’s catheters.”
  • MedPage Today tells us,
    • “The FDA cleared medical-grade Australian sheep blowfly (Lucilia cuprina) larvae in what maker Cuprina Holdingsopens in a new tab or window believes marks the first debridement product to use this particular species.
    • “Dubbed Medifly Maggots, the product is indicated for removing dead or infected tissue from non-healing necrotic skin and soft tissue wounds — such as pressure or neuropathic foot ulcers — and non-healing traumatic or post-surgical wounds.
    • “A healthcare worker is required to oversee the application of the prescription maggot product, which was cleared based on demonstration of equivalence to the previously cleared medical-grade green bottle blowfly larvae — Lucilia sericata (Medical Maggots).”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has struck down key provisions in a CMS rule overhauling the Affordable Care Act, in a setback for the Trump administration’s push to combat fraud that critics argue is a smokescreen for weakening the exchanges set up by the Obama-era law.
    • “On Friday, Judge Brendan Hurson of the Maryland District Court vacated eight of the rule’s most consequential provisions, including the creation of a $5 premium penalty for individuals who automatically reenroll in coverage and a policy disqualifying people who fail to reconcile tax credits with their income from receiving subsidies.
    • “The decision is not a surprise after Hurson stayed most of the provisions last year. Still, officially tossing them out is a victory for proponents of expanded ACA coverage — though a short-term one, given many of the changes were codified in the GOP’s “Big Beautiful Bill” passed last summer.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “A pregnant woman in rural Arizona with syphillis could have been treated fairly easily with an injection of penicillin. But the drug, Bicillin L-A, is manufactured only by Pfizer, and has been in short supply for a year now — which meant the drug arrived too late to prevent probable congenital syphilis in her newborn.
    • “The syphilis epidemic is worsening, congenital syphilis cases are up roughly 800% since 2012 — and this Bicillin shortage is expected to continue through 2027. Public health officials say Pfizer’s emergency allocation system is confusing and may disadvantage health departments serving low-income patients.
    • “A box of 10 syringes can cost around $8,000, and the drug is manufactured at only one Pfizer plant in Michigan to supply the whole country.
    • “Most shortages are of not-very-profitable drugs,” said Erin Fox, associate chief pharmacy officer at University of Utah Health.”
  • The American Medical Association lets us know what doctors want patientsto know about allergic rhinitis
    • “Allergic rhinitis, or hay fever, is more than just the sniffles. Understanding triggers and when to talk to a physician are key to managing allergic rhinitis.”
  • Per an National Institutes of Health news release,
    • “A clinical trial supported by the National Institutes of Health (NIH) found that adults with prediabetes assigned to a lifestyle intervention had a significantly lower risk of developing multiple chronic health conditions (known as multimorbidity) over time than those assigned to a placebo. This study, which followed participants for over two decades, also found that participants assigned to receive metformin did not experience a statistically significant reduction in multimorbidity risk. The findings, published in JAMA, highlight the lasting benefits of lifestyle programs that may lower risk of the development of chronic conditions.
    • “Multimorbidity is a common issue, and few interventions have been found to prevent or delay developing multiple chronic conditions,” said Marcel Salive, M.D., first author of the study, from NIH’s National Institute on Aging (NIA). “Our work showing that healthy lifestyle intervention can significantly lower the burden of multimorbidity is a step forward in addressing this growing problem.”
  • MedPage Today relates,
    • “COVID-19 vaccines were associated with a lower risk of major adverse cardiovascular events in “a cohort study of veterans.
    • “The 2024-2025 vaccines also demonstrated effectiveness against COVID-associated emergent care, hospitalization, and critical illness among adults.
    • “Among older adults who received a 2025-2026 vaccine, overall COVID vaccine effectiveness against symptomatic disease was 59%.
  • Healio tells us,
    • “Less than a quarter of patients with stroke and fewer than one in seven with traumatic brain injury were discharged to inpatient rehabilitation.
    • “Clinicians should plan for rehabilitation early and make it an intentional part of care.”
  • and
    • “The American College of Physicians (ACP) has published living clinical guidance to help physicians select medications for patients with overweight or obesity.
    • “Unhealthy weight remains a significant public health issue globally, with 68.5% of American adults and 59% of adults worldwide having overweight or obesity, according to Amir Qaseem, MD, PhD, MHA, MGIN, MRCP, FACP, ACP chief science officer and senior vice president of clinical policy at the Centers for Evidence Reviews, and colleagues.
    • “They wrote in Annals of Internal Medicine that first-line treatments for obesity and overweight include physical activity and nutrition, but the new guidance “addresses additional management using pharmacologic treatments when lifestyle modifications alone do not result in optimal weight loss or weight maintenance for a person.”
  • Pharmacy Times informs us,
    • “Pooling ATTAIN-1/2 female participants, menopausal stage–stratified outcomes at 72 weeks included weight, waist circumference, waist-to-height ratio, and categorical weight-loss thresholds using an efficacy estimand. 
    • “Orforglipron [Lilly’s oral GLP-1 drug] achieved statistically significant placebo-adjusted reductions across premenopause, perimenopause, and postmenopause, reaching approximately 14% body-weight loss and up to 11 cm waist reduction (P<.001). 
    • “Clinically meaningful responder rates favored orforglipron, with up to 83% achieving ≥5% weight loss vs 23% on placebo, and higher rates across ≥10%, ≥15%, and ≥20% thresholds. 
    • “More participants shifted to lower waist-to-height ratio categories on active therapy, supporting potential visceral adiposity and cardiometabolic risk mitigation in menopause-associated fat redistribution. 
    • “Unrestricted oral administration (no food/water requirements) may reduce adherence barriers in midlife women with polypharmacy, strengthening pharmacist-led counseling and referral pathways in obesity care.”
  • BioPharma Dive points out,
    • “An experimental drug that Eli Lilly recently picked up through a potentially multibillion-dollar acquisition appears to have passed its first major test, scoring positive results in a small study of patients with hard-to-treat blood cancer.
    • “Originally developed by Ajax Therapeutics, the drug inhibits an enzyme that spurs blood cell production. Several medicines that block this “JAK2” enzyme, including Incyte’s Jakafi, are already on the market, where they’re mostly used in rare, chronic blood cancers like myelofibrosis. While these medicines can be quite effective at treating symptoms, many patients either don’t respond or stop taking them because their disease progresses or they can’t tolerate the side effects, which range from nausea and fatigue to anemia and increased stroke risk.
    • “Lilly’s pill is designed to work in a slightly different way than its approved counterparts, binding to JAK2 in the “inactive” state. Researchers hypothesize this change should make for a superior therapy that also overcomes drug resistance challenges.
    • That idea now has more support thanks to data presented over the weekend at a major medical meeting in Europe.”

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

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. will launch a new line of commercial health plans called Edge across all five of its Blue Cross Blue Shield states beginning in 2027.
    • “The plans, powered by a proprietary plan design called Easify, have no deductibles and no coinsurance for in-network care, leaving members with fixed copays, according to a June 11 news release. 
    • “HCSC said the PPO plans aim to let employees in Illinois, Texas, Oklahoma, Montana and New Mexico anticipate out-of-pocket costs more easily and help employers better manage total medical spend. HCSC also said the new product will steer members toward “high-value” care using behavioral incentives.” 
  • Beckers Hospital Review relates
    • “Middle-age adults who use GLP-1 medications for obesity could save an average of $192,735 in lifetime medical costs, according to a study published in June by the National Bureau of Economic Research. 
    • “Researchers from Los Angeles-based University of Southern California simulated health and economic outcomes for U.S. adults ages 25 and older, comparing lifetime trajectories for people who used GLP-1s for obesity with those who did not. Obesity was defined as a body mass index higher than 30.”
  • and
    • “Virtual nursing for hospital discharge was associated with sharply lower 30-day emergency department readmissions across nine hospitals in a major Southeastern U.S. health system, according to a study published in npj Digital Medicine.
    • “Researchers at the University of North Carolina at Chapel Hill compared 4,662 discharges handled by remotely located virtual nurses with 4,662 traditional in-person discharges, matched on patient and hospital characteristics. Patients discharged through virtual nursing returned to the ED within 30 days at a rate of 3.7%, versus 13.3% for in-person discharge — a 72% relative reduction, or a risk ratio of 0.28. That works out to roughly 1 readmission in 27 virtual-nursing patients, compared with 1 in 8 receiving standard discharge.
    • “The effect held in both settings, with the gap widest in rural hospitals: 3.1% versus 17.9% rural, and 4.1% versus 10.7% urban.
    • “Virtual nurses delivered structured, uninterrupted discharge education — medication reconciliation, teach-back, and care-plan review — from an off-site center operating 7 a.m. to 7 p.m., seven days a week. The health system rolled out the model across the nine hospitals between 2022 and 2024.”
  • MedTech Dive informs us,
    • “Medtronic said Friday it has completed the $550 million takeover of neurovascular technology company Scientia Vascular.
    • “The deal, which Medtronic disclosed in March, covers guidewire technologies for stroke that are designed to equip physicians to access hard-to-reach parts of the brain.
    • “Buying Scientia will enable “every neurovascular procedure to start with Medtronic,” CEO Geoff Martha said on an earnings call with investors this month.”
  • Medical News Today points out,
    • Three AI-based mammography systems were able to identify subtle signs of future breast cancer years before diagnosis, with elevated cancer prediction scores seen in those who later developed the disease. 
    • In the study, approximately 20% of breast cancer cases showed AI-detectable mammographic changes as early as 6 years before diagnosis. 
    • At 90% specificity, the AI systems flagged potential future cancers in up to 19.7% of women 6 years before diagnosis, 25.2% 4 years before diagnosis, and 39.3% 2 years before diagnosis. 
    • The findings suggest AI could support earlier breast cancer detection and help enable more personalized screening strategies by identifying females who may benefit from closer monitoring or earlier intervention.
  • FYI, The Blue Cross Blue Shield Association has a job opening on its Legal Team supporting FEP.

Monday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Roll Call takes a look at what’s ahead of Congress this week,
  • and also lets us know,
    • “President Donald Trump on Monday sent to the Senate the nomination of acting Attorney General Todd Blanche to fill the role permanently, teeing up what could be a bruising confirmation process for a Trump ally who has drawn bipartisan criticism for recent Justice Department moves.”
  • Per a HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Education today hosted eight of the nation’s leading accreditors, assessors, and medical organizations to announce a historic development to increase nutrition requirements at every level of U.S. medical education, competency-evaluation, training, and residency. Additionally, 19 medical schools across the country have signed the Trump administration’s Nutrition Education Pledge, vowing to incorporate 40 hours of nutritional education or its competency equivalent into graduation requirements starting this fall.
    • “Poor diets are the primary driver of America’s chronic disease epidemic, and today’s announcement reflects the shifting landscape toward placing nutrition and prevention at the core of patient health,” said Secretary Robert F. Kennedy, Jr. “Still, more work remains, and I look forward to seeing nutrition play an increased role as the latest science, data, and best practices develop.”
    • “Last August, HHS and the Department of Education sent a letter to medical organizations encouraging them to improve their standards and place nutrition at the core of their programs.”
  • Beckers Hospital Review informs us,
    • “TrumpRx.gov is adding 160 prescription drugs to the platform, bringing its total to more than 800  according to a June 5 Truth Social post from President Donald Trump.
    • “The president said the expansion would allow TrumpRx.gov to offer discounted pricing for medications that account for roughly four out of every five prescriptions filled in the U.S. The administration also claims the platform has saved American patients more than $400 million since its February launch.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced additional leading technology companies have committed to partnering with the US Tech Force (Tech Force), the government-wide initiative to recruit top technologists to modernize the federal government and strengthen America’s technical workforce.
    • “The new industry partners include Arista Networks, Armada, Cisco, Cognition AI, Cognizant, Payward, Moveworks from ServiceNow, Scale AI, and Wiz.
    • “These companies will contribute to Tech Force by providing technical training resources, executive engagement and programming, nominating employees for temporary government service, and helping create paths for Tech Force alumni into the private sector.” * * *
    • “More information about Tech Force is available here.”
  • The American Hospital Association News reports,
    • “The Drug Enforcement Administration today released a final rule implementing provisions from the Restoring Hope for Mental Health and Well-Being Act of 2022, which passed as part of the Consolidated Appropriations Act of 2023, eliminating the need for a separate waiver for qualified practitioners to dispense certain types of controlled substances for medications for opioid use disorder treatment, or MOUD. While the original requirements were amended by the SUPPORT Act of 2018 and changes were implemented in an interim final rule in 2020, the 2022 legislation struck the amended section from regulation, thus requiring DEA to respond to public comments on the interim final rule and update regulatory language accordingly.”

From the Food and Drug Administration front,

  • Fierce Pharma informs us
    • “The FDA has expanded the label for Pfizer’s subcutaneous hemophilia drug Hympavzi, now including patients age 6 and older who have hemophilia A or B.
    • “The anti-tissue factor pathway inhibitor was initially approved in October of 2024 for those age 12 and older with hemophilia A or B who have not developed the antibodies—also known as inhibitors—produced by the immune system that block or destroy infused clotting factor medications.
    • “The new expansion covers all patients 6 and older, regardless of their inhibitor status. The new nod also opens up the treatment to those 12 and older who have developed the inhibitors.”
  • CBS News reports,
    • “Retatrutide isn’t supposed to be everywhere.
    • “Touted as the next generation in the GLP-1 craze, it’s an experimental weight-loss drug that is not authorized outside of clinical trials. The Food and Drug Administration hasn’t reviewed whether it is safe and effective, which is the legal path for prescription drugs to come to market. And yet retatrutide is for sale all over the internet, a phenomenon with no modern precedent.
    • “It isn’t just shadowy online vendors offering what they claim to be research-grade retatrutide.
    • “A CBS News investigation found dozens of clinics across the country, staffed by licensed physicians and nurse practitioners, openly advertising retatrutide. That practice defies a longstanding norm in medicine – to wait for the FDA to approve a drug before prescribing it – and is contributing to a booming commercial marketplace for a drug that is barred from sale by federal law.” * * *
    • “It’s on the states to really police this kind of conduct,” said Nathan Cortez, a professor at SMU Dedman School of Law, adding that they often lack enforcement resources. “At some point it becomes so blatant and widespread that, you’re wondering, ‘What are we doing here? Are we going to enforce the law or not?'”
  • The Wall Street Journal adds,
    • Eli Lilly LLY shares rose in early European trade after a late-stage trial showed its drug was effective in weight loss and in alleviating obesity-linked conditions.
    • “Shares jumped 4.4% premarket to $1,181, extending a record high hit at Friday’s market close. The stock is up over 30% since the Indiana-based company reported first-quarter earnings on April 30.
    • “Participants in a Phase 3 trial of retatrutide—an experimental drug targeting obesity-related hormones—showed substantial weight loss, with those taking 12 mg doses losing an average of around 70 pounds over an 80-week period, the company said.
    • ‘One-third of participants on 12 mg doses saw their weight fall into a healthy weight range, while two-thirds fell below the threshold for obesity, Eli Lilly said.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The U.S. District Court for the District of Massachusetts June 8 vacated the $100,000 fee for new H-1B visas established by a proclamation in September 2025. Judge Leo T. Sorkin declared the fees unlawful and said in his decision that it “exceeds the fee-setting authority delegated by Congress.” The AHA last year asked the administration to make healthcare personnel exempt from the fees. The federal government is likely to appeal the June 8 decision.”

Reports from the American Diabetes Association’s annual meeting,

  • Fierce Pharma adds,
    • “With an obesity green light already in hand, Eli Lilly is pushing for its newly launched Foundayo (orforglipron) to break into Type 2 diabetes, in turn rounding out its oral offering in line with Novo Nordisk’s duo of GLP-1 pills in both indications. 
    • “Now, in results from a trio of pivotal phase 3 studies presented Monday at the American Diabetes Association 2026 Scientific Sessions, Lilly is aiming its diabetes data squarely at two of the oral GLP-1’s biggest potential rivals.
    • “Sure to grab the most attention at the conference are results from Achieve-3, a head-to-head trial in which Foundayo topped Novo’s oral semaglutide on metrics of blood sugar reduction and weight loss in T2D patients.” 
  • STAT News notes,
    • “AstraZeneca’s investigational GLP-1 pill showed promise in mid-stage obesity and diabetes studies, but it may still be too early to determine how it stacks up against oral treatments already on the market.
    • “In one Phase 2 trial of people with obesity, called VISTA, those on the highest dose of the drug, called elecoglipron, lost 11.2% of their weight after 36 weeks, when looking at all patients regardless of discontinuations, according to data presented Monday at the annual meeting of the American Diabetes Association and published in the Lancet. (Eli Lilly’s pill Foundayo led to the same rate of weight loss in a Phase 3 study that lasted twice as long, but it’s hard to compare across trials in different phases.)”
    • “In a separate Phase 2 trial in people with diabetes, called SOLSTICE, patients on the highest dose saw up to a 1.74 percentage-point decrease in a measure of blood sugar called A1C after 26 weeks. The study, also published in the Lancet, enrolled people taking oral Ozempic open-label as a comparator group, and they experienced a smaller A1C decrease of 1.32 percentage points.”
  • The American Journal of Managed Care relates,
    • “A trio of studies presented at the American Diabetes Association 2026 Scientific Sessions has reframed the conversation of diet during pregnancy, pointing to diet quality, not just quantity, as a meaningful lever for managing gestational glycemia and postpartum metabolic risk. This is a conversation that has long been viewed through the narrow lens of weight gain and fetal growth.
    • “Across hundreds of pregnancies, researchers of 3 oral presentations found that higher intake of fiber, nonstarchy vegetables, and plant protein were independently associated with lower continuous glucose monitor (CGM) readings,1 while lower-carbohydrate diets in women with gestational diabetes improved glycemic control but raised micronutrient concerns.2 Perhaps most strikingly, women randomly assigned to a higher-complex carbohydrate diet during pregnancy still showed measurably lower postpartum glucose responses 2 months after delivery, suggesting that what a pregnant woman eats may matter long after the birth.3
    • “Together, these findings challenge prevailing assumptions about optimal gestational nutrition and open new questions about how prenatal dietary interventions might be designed to protect both mother and child over the long term.”

From the public health and medical / Rx research front,

  • BioPharma Dive reports,
    • “Tango Therapeutics said Monday its experimental drug vopimetostat showed promise in a small trial in pancreatic cancer, with nearly all of the enrollees followed so far responding to a regimen that combined its medicine with Revolution Medicines’ closely watched treatment daraxonrasib.
    • “The data suggest vopimetostat outperformed daraxonrasib alone in a similar population of people whose disease had progressed after at least one treatment line and exceeded Wall Street expectations. The company plans to initiate a Phase 3 trial later this year testing the combination.” 
  • The American Medical Association lets us know what doctors wish their patient knew about diverticulitis.
    • “Diverticulitis can turn silent colon pouches into painful inflammation. But plenty of interventions are available, depending on severity of diverticulitis.”
  • Per a National Institutes of Health news release,
    • “By inducing specific patterns of activity in small portions of the brain in awake mice, researchers supported by the National Institutes of Health (NIH) have triggered a recalibration of neural connections that normally only occurs during sleep. This new approach offset the effects of sleep deprivation in memory tasks and revealed features of sleep that are key to its restorative effect.
    • “What we’re essentially doing is forcing sleep in a local region of the brain. While that part is solidifying memories and restoring learning capacity, other parts stay aware/vigilant and connected to environment,” said corresponding author Chiara Cirelli, M.D., Ph.D., a professor of psychiatry at the University of Wisconsin-Madison. “Dolphins do something similar, sleeping with only one brain hemisphere at a time.”
    • “Non-rapid eye movement (NREM) sleep, which makes up about 80% of sleep for adults, is when the junctions between neurons that make memories are evaluated. During this phase, the brain protects important connections for long-term storage, prunes those that are less necessary, and makes space for new ones.”
  • Genetic Engineering and Biotechnology News relates,
    • “A study tracking thousands of B cells across more than 100 germinal centers (GCs) in mice has revealed how the system consistently produces highly effective antibodies. The findings overturn longstanding ideas about how germinal centers function, revealing that they are far more selective than once thought, and challenge the idea that antibody improvement is driven mainly by rare growth “bursts” among the most successful B cells. The discovery could have implications for immune cell evolution, and ultimately guide the design of vaccines against rapidly mutating pathogens like influenza. It could also lead to new ways of studying evolution itself.
    • “The traditional, mechanistic view of germinal centers is to think of them as selection machines sorting out the best antibodies,” said research lead Gabriel D. Victora, PhD, head of the Laboratory of Lymphocyte Dynamics at The Rockefeller University. “But when you look very, very closely, you see a process that’s almost essentially random—a little bit better than a coin toss—which repeats many times until the immune system arrives at the right answer consistently. That’s much more akin to how evolution operates than the way a machine does.”
    • “Victora and colleagues reported on their findings in Cell, in a paper titled “Replaying germinal center evolution on a quantified affinity landscape.”
  • Medscape points out,
    • “Metabolic-bariatric surgery (MBS) in patients aged 65 years or older resulted in long-term meaningful weight loss and remission of obesity-related conditions, although complication rates of about 8% were noted.”
  • The Cancer Therapy Advisor notes,
    • “Hyperthyroidism may be associated with an increased risk of breast cancer, particularly premenopausal breast cancer, according to research published in Cancer Epidemiology, Biomarkers & Prevention.
    • “Findings from in vitro studies have indicated that thyroid hormones can have estrogen-like effects. That suggests that thyroid hormones may affect cellular proliferation of breast tissue and subsequently increase breast cancer risk in people with hyperthyroidism, researchers explained. In this study, the researchers assessed the effects of hyperthyroidism and hypothyroidism on incident breast cancer in women from the Sister Study.
    • “Women diagnosed with hyperthyroidism or receiving related treatment may have elevated BC [breast cancer] risk, particularly premenopausal BC,” the researchers concluded. “Although more research is needed, premenopausal women treated for hyperthyroidism may benefit from enhanced breast cancer screening.”

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

  • Fierce Healthcare reports,
    • “Medicare Advantage insurer Essence Healthcare is continuing to build out its partnership with Oura and has unveiled a new clinical program that aims to identify potential sleep apnea risk.
    • “Essence is rolling out a new clinical workflow that will arm physicians with insights into patients’ nighttime breathing habits to identify those who may be at risk for obstructive sleep apnea. The insurer offers the ring as a covered benefit through some of its plans and has been working with Oura’s team to identify more clinical applications for its data.
    • “News of the partnership expansion was shared first with Fierce Healthcare.
    • “Through the program, insights into members’ sleep, as identified by the Oura Ring, will be shared with Essence with the patients’ consent. The insurer then uses Lumeris’ Tom platform to reach out to at-risk individuals and guide them through STOP-BANG, a common evidence-based screening for sleep apnea.”
  • and
    • “Artificial intelligence is here to stay in healthcare, and the industry’s largest players, like CVS Health, are making huge commitments to the tech.
    • “But embracing AI requires a workforce that’s ready for the revolution. With that backdrop, CVS has rolled out its internal AI Learning Academy, which aims to educate its workforce on practical applications for the technology and how it can impact and improve their workflows.
    • “The program was built in collaboration between human resources and tech leaders at the company. Greg Karanastasis, senior vice president for talent and development at CVS, told Fierce Healthcare that the aim was to build something bigger than just a training program.”
  • Per an Institute for Clinical and Economic Research (ICER) news release,
  • MedCity News tells us about “The 3 Biggest Roadblocks to Egg Freezing — and How Providers Are Working to Remove Them.”
    • “Egg freezing has gained popularity as a fertility preservation tool, but experts say high costs, uncertain outcomes and timing challenges continue to deter many women from pursuing it.”
  • MedTech Dive informs us,
    • “Boston Scientific is investing approximately $138 million to build a 500,000-square-foot distribution facility in Plainfield, Indiana.
    • “Indiana Gov. Mike Braun, who announced the project last week, said Boston Scientific will break ground on the facility this year and ultimately create up to 300 jobs. 
    • “Boston Scientific is building the facility to complement its existing distribution network, which includes sites in Georgia, Massachusetts and Minnesota.”
  • BioPharma Dive notes,
    • “Incyte, a drugmaker with a heavy focus on blood diseases and cancers, plans to take control of an experimental medicine that could help control bleeding in a variety of disorders.
    • “Vega Therapeutics, a subsidiary of the “hub-and-spoke” biotech Star Therapeutics, has been developing this “VGA039” medicine primarily as a treatment for von Willebrand disease — the most common inherited bleeding disorder. Now, Incyte has agreed to buy Vega for $1.25 billion up front. Star would be eligible to receive as much as $750 million more if certain sales goals are eventually met.
    • “Patients with von Willebrand disease lack an important clotting protein, meaning that, when they suffer any kind of injury, the bleeding usually takes longer to stop. In severe cases, this bleeding can cause joint or organ damage and be life-threatening. Current preventative treatments include so-called factor replacement therapies given as intravenous infusions two to three times a week. VGA039, meanwhile, comes as a once-monthly, under-the-skin injection that patients can do themselves.”
  • The Wall Street Journal relates,
    • “Roche Holding struck a deal with Nurix Therapeutics NRIX to license an experimental blood-cancer drug for up to $2.3 billion, expanding its pipeline in oncology and potentially other therapeutic areas.
    • The Swiss drugmaker on Monday said it would make an upfront cash payment to Nurix of $700 million, with additional payments subject to the drug, bexobrutideg, reaching development, regulatory and sales targets.
    • Bexobrutideg is due to enter late-stage studies for the treatment of chronic lymphocytic leukemia this summer, Roche said.
    • “The main opportunity for us is in B-cell malignancies. There are many B-cell malignancies and the most dominant of interest for us is chronic lymphocytic leukemia,” Roche’s deputy chief medical officer, Stefan Frings, said in an interview.
    • “The company said the medicine has potential to offer higher efficacy and more favorable tolerability than established therapies for leukemia. The drug is a so-called BTK degrader designed to remove the BTK enzyme from cells, rather than blocking its effects, and overcome resistance.”
  • and
    • “Johnson & Johnson JNJ  has agreed to buy biotechnology company Firefly Bio for $1 billion in cash in a deal that bolsters the drugmaker’s oncology pipeline.
    • “J&J on Monday said Firefly is developing its proprietary Firelink degrader antibody conjugate platform, for KRAS-driven cancers, which have limited treatment options with survival measured in months.
    • “Mutations of the KRAS gene have long been considered undruggable because the gene’s structure lacks the deep binding pockets most drugs need.
    • ‘J&J said the Firelink platform is a novel approach to overcome limitations of existing treatments by delivering a highly selective protein degrader to tumor cells, while avoiding healthy cells.”
  • and
    • “Novo Nordisk NOVO.B said prescriptions for its Wegovy weight-loss pill have surpassed three million since launching in early January.
    • “The Danish drugmaker said late Sunday that the pill hit one million prescriptions 12 weeks after reaching U.S. pharmacies and online providers, with a further two million prescriptions achieved in the following 10 weeks.
    • “More than 80% of new prescriptions filled for the Wegovy pill are for patients new to the GLP-1 class of drugs, which the company says indicates that the new oral formulation is expanding the obesity treatment market, rather than replacing existing injectable therapies.”
  • Fierce Pharma adds,
    • “On a weekly basis, total GLP-1 prescriptions were trending downward over the week of June 1, falling 5.7% week-over-week, Citi analysts noted. Other than the continued rollout of Lilly and Novo’s respective weight loss pills, the analysts cited the effect of the Trump administration’s “most favored nation” pricing policies as a key future event that they think could impact total prescriptions.” 

Noteworthy Death

  • AP reports
    • “Harvard University professor Robert Coles, the psychiatrist and Pulitzer Prize-winning author who championed the cause of children grappling with poverty and segregation, has died at 97, his son said Sunday.
    • “The son, also named Robert Coles, told The Associated Press that his father died Thursday at a hospice center in Lincoln, Massachusetts.
    • “The elder Coles was famed for documenting the needs of children, particularly those caught in the crucible of social upheaval. The second and third parts of his five-volume “Children of Crisis” won him a Pulitzer Prize in 1973 for general nonfiction.
    • “In a 1965 Washington Post essay, he wrote that, expecting to find many psychiatric problems among the children of poverty, that instead “I was constantly surprised at the endurance shown by children we would all call poor or, in the current fashion, ‘culturally disadvantaged.’”
  • RIP

Weekend Update

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

Simplicity is a virtue.

  • Per a House Energy and Commerce Committee news release,
    • “The Subcommittee on Health has scheduled a hearing on Wednesday, June 10, 2026, at 10:15 a.m. (ET) in 2123 Rayburn House Office Building. The title of the hearing is “Lowering Health Care Costs for All Americans: Examining Policies to Increase Health Care Transparency.”
  • HR Dive reports,
    • “A hospital may employ staff as overtime-exempt specialists who simultaneously take shifts performing nonexempt staff nurse work during the same workweek without altering the employees’ exemption status under the Fair Labor Standards Act, the U.S. Department of Labor said in an opinion letter issued Thursday.
    • “The document is one of a group of four letters issued last week by DOL Wage and Hour Division Administrator Andrew Rogers. Rogers said the FLSA’s executive, administrative and professional overtime exemption applies to employees whose “primary duty” involves performance of exempt work.”

From the public health and medical / Rx research front.

  • The Wall Street Journal reports,
    • “The federal government reported America’s total fertility rate dropped to 1.57, sparking alarm about a graying, shrinking population.
    • “Experts note the 1.57 total fertility rate is a snapshot, with 30% of the decline from falling teen pregnancy rates.
    • “Medical solutions like IVF and egg freezing, along with policies for workplace flexibility and childcare, are discussed to address declining fertility.”
  • and
    • “Cancer rates are rising among people under 50, an alarming trend that has led some patients to take preventive measures. While women under 45 make up a small number of overall breast cancer cases, incident rates have increased 1.1% each year for the past 10 years. 
    • “Armed with more information than ever about their genetics, women with higher risk factors are opting for surgeries that reduce their odds of developing cancer by as much as 95%. Doctors specializing in breast reconstruction say they are seeing ever-younger women opting to remove their breasts as a prophylactic measure. 
    • “At this point, seeing a patient in their early 30s is totally routine,” said Dr. Steven Sultan, a plastic and reconstructive surgeon at New York City’s Mount Sinai Hospital, referring to cancer patients. He said about 20% of his cases are prophylactic, a term that encompasses women who take action as soon as they learn about genetic risk factors and those who have undergone biopsies after suspicious scans but do not have cancer. In the past few years, he’s seen a notable change in 20-somethings coming into his office, both with cancer as well as for prophylactic surgeries.” 
  • The New York Times relates,
    • “Scientists at Columbia University have edited the DNA of early human embryos with unprecedented accuracy, an achievement that could open the way to babies engineered with particular characteristics.
    • “The prospect has fueled controversy for years. On the one hand, the technology might one day enable parents to safely repair disease-causing mutations in embryos. But it might also be used to select desired traits — a practice that some ethicists have argued is nothing short of eugenics.
    • “Dieter Egli, a geneticist at Columbia University who led the research, called for a public conversation about the pros and cons of altering embryonic DNA. “As a scientist, you can provide the data for discussion, but then essentially there you stop and let others take over,” he said.
    • “With a newer technology called base editing, Dr. Egli and his colleagues were able to meticulously replace individual genetic letters in sequences of DNA without causing the damage often observed with an earlier form of gene editing, CRISPR.
    • “Dr. Egli cautioned that the research left unanswered many questions about harmful side effects. “We’re not saying this is going to be used tomorrow in the clinics,” he said.
    • “Dr. Egli and his colleagues posted their study online. The research is under review for publication in a scientific journal.”
  • Medscape tells us,
    • “Metabolic disruptions in individuals with alcohol use disorder (AUD) and obesity may intensify alcohol cravings, suggesting a potential metabolic-addictive axis. This highlights the need for integrated treatment approaches targeting both metabolic and addiction pathways.” * * *
    • “Lead author Zachary Harvanek, MD, PhD, assistant professor of medicine at Yale School of Medicine, New Haven, Connecticut, cautioned that the findings are preliminary and require confirmation in larger studies before they can influence clinical practice. However, he said the results suggest that metabolic health may play a meaningful role in alcohol cravings and could help identify a distinct subgroup of patients with AUD at an especially high risk for relaThe findings also support growing interest in therapies that target metabolic pathways, including GLP-1s, as potential treatments for AUD in certain patients.
  • and
    • “Behavioral economics may enhance obesity management by improving adherence to lifestyle changes through financial incentives, gamification, and digital nudges. These strategies could complement pharmacologic treatments, though their long-term effectiveness remains uncertain.” * * *
    • “We all know that many patients regain weight after stopping GLP-1 medications — often a large proportion of what they lost within a year,” said Thomas Tsang, MD, chief medical officer at Omada Health. “In many cases, it’s because patients never had the opportunity to learn the behavioral skills and lifestyle tools needed to sustain those changes after the medication is stopped.”
    • “Tsang also expressed caution about programs that rely primarily on financial incentives. “If the incentive is purely financial, the concern is whether the behavior change will last after the incentive disappears,” he said. “What matters more is helping people develop durable habits and confidence that they can sustain over time.” * * *
    • Tsang also raised ethical concerns about programs that rely heavily on financial incentives, particularly if they disproportionately target economically vulnerable populations.
    • “There’s a fine line between rewarding progress and essentially paying people to lose weight,” he said. “We want patients focused on health and sustainable behavior change, not just achieving a short-term goal for a financial reward.”
    • “For now, most experts view behavioral-economics interventions as promising but still evolving tools.
    • “As the obesity treatment landscape expands — particularly with the rapid adoption of new pharmacologic therapies — understanding how behavioral design can support long-term adherence may become an increasingly important area of research.”
  • STAT New informs us,
    • “Detailed data from a mid-stage study offered further evidence that the obesity drug Pfizer acquired from the biotech Metsera could be dosed monthly. But it’s not clear how competitive the treatment would be against weekly injectables on the market and in development that may lead to greater weight loss.
    • “In the study, called VESPER-3, patients with obesity took weekly doses of the drug, called berobenatide, for 12 weeks and then transitioned to higher monthly doses out to 28 weeks. By then, patients lost up to 12.1% of their weight, when analyzing just those who stayed on treatment, as Pfizer previously reported. 
    • “New data presented at the annual meeting of the American Diabetes Association on Saturday show that when patients transitioned from weekly to monthly dosing, the rate of weight loss continued at a similar pace; they had not yet hit a plateau by 28 weeks. That’s a promising sign, but the rate of weight loss at 28 weeks was still less than what was seen at a similar time point in the pivotal trial of Eli Lilly’s Zepbound.
    • “Additionally, up to 11.3% of treated patients discontinued because of side effects, compared with none in the placebo group. When patients in the highest-dose groups transitioned from a weekly dose of 1.2 milligrams to monthly doses that were four times as large (4.8 mg), they experienced a notable increase in nausea and vomiting, the new data show.
    • “To help improve tolerability, Pfizer will titrate the monthly doses going forward rather than put patients on the 4.8-milligram dose right away, said Jim List, the company’s chief internal medicine officer.”
  • Healio points out,
    • “A triple receptor agonist provided weight loss for adults with obesity, with or without type 2 diabetes, to an extent not seen with previous pharmacotherapy options, according to data from two phase 3 trials.
    • “During a symposium at the American Diabetes Association Scientific Sessions, researchers presented data from phase 3 trials investigating retatrutide (Eli Lilly), a once-weekly injectable GLP-1/GIP/glucagon triple hormone agonist. In the TRIUMPH-1 trial, the medication led to weight loss of up to 25% at 80 weeks and up to 29.9% at 104 weeks with the highest dose, as well as other benefits. 
    • “Retatrutide … was generally well tolerated, and provided substantial reduction in weight, as well as clinically meaningful improvements in health outcomes for patients with obesity, obstructive sleep apnea and knee osteoarthritis,” Ania M. Jastreboff, MD, PhD,director of the Yale Obesity Research Center and principal investigator of the TRIUMPH-1 trial, said in a press conference.
    • “In the TRANSCEND-T2D-1 trial, which was simultaneously published in The Lancet, HbA1c declined by 1.9 percentage points at 40 weeks for adults with type 2 diabetes with the two highest doses of the drug. Additionally, mean weight loss with the highest dose of retatrutide reached 12.7% at 40 weeks.”
  • MedPage Today let us know,
    • “Two investigational drugs for lupus with encouraging primary phase II results yielded more good news from follow-on studies, reports here indicated.
    • “The Toll-like receptor (TLR) inhibitor enpatoran showed no diminution and perhaps some increase in efficacy for patients with cutaneous and systemic lupus with 48 weeks of additional treatment beyond the original 24 weeks, and no new safety concerns arose, according to Eric Morand, MBBS, PhD, of Monash University in Melbourne, Australia.
    • “The other study involved the anti-B cell agent ianalumab that is being tested in systemic lupus (and a variety of other conditions). Edward Vital, MBChB, PhD, of the University of Leeds in England, reported data collected after treatment had stopped in a phase II trial and after B-cell populations had rebounded. With a median of 44 weeks of post-treatment follow-up, not only did biomarker responses continue unabated, clinical indices also showed little loss of efficacy.” * * *
    • For both drugs, the phase II results were strong enough that their respective sponsors have initiated twinned phase III trials: ELOWEN-1and ELOWEN-2 for enpatoran, and SIRIUS-SLE-1 and SIRIUS-SLE-2 for ianalumab.

From the U.S. healthcare business report,

  • MedCity News reports about “The Smart Way to Build the Future of Fertility Benefits.
    • “The challenge isn’t just access to fertility benefits, it’s how those benefits are structured and delivered. Here are three emerging themes that can help employers better align cost, quality and experience.” * * *
    • “First, look “under the hood” when evaluating healthcare options. Don’t just look at the price tag; compare the outcomes. High-quality medical care saves money in the long run and leads to better results. Accurate diagnostics, advanced lab practices, and evidence-based protocols increase the likelihood of pregnancy and reduce the number of failed IVF cycles – saving time, money, and emotional strain for employees. 
    • “Second, prioritize collaboration, not fragmentation. Fertility care works best when clinicians, labs, and pharmacies operate in a more coordinated way. Collaboration enables faster, better-informed decisions, reduces referrals, and shortens the time to pregnancy. It also lowers costs by avoiding redundant testing and treatment. For employees, integrated care means less logistical stress and more confidence in the process. 
    • “Third, demand transparency in drug pricing. IVF medications can be one of the most opaque and wasteful parts of the process. Typically, patients receive their rebates at the end of the year, if at all, while leftover drugs go unused. More transparent approaches, including upfront drug pricing, same-day delivery, and as-needed dispensing, reduces waste and helps employees with financial planning.” 
  • The Wall Street Journal relates,
    • “Coverage for Ozempic and other drugs used for weight loss has fast become one of the most coveted workplace benefits—so much so that companies say they can no longer afford to provide it.
    • “With as many as one in eight American adults taking the pills or injectables now, big employers from Cigna to PricewaterhouseCoopers are dropping coverage of so-called GLP-1s in droves. Others, like Chevron, are making workers jump through extra hoops to get coverage—and to ensure the drugs are used effectively—such as requiring multiple weigh-ins a month, meal-tracking on apps or sessions with an online health coach. 
    • “More than a quarter of big companies say they are adding criteria this year or next, while 11% have dropped or are planning to drop coverage for weight-loss purposes altogether, according to soon-to-be released data from benefits-advisory firm Mercer.”
  • and
    • “A columnist wore an Oura Ring 5, Google Fitbit Air, Whoop MG, and Apple Watch Series 11 for three weeks to compare their performance.
    • “Sleep tracking was tested against a polysomnogram in a sleep study; the Apple Watch and Fitbit Air showed the most accurate sleep duration.
    • “Heart-rate tracking was compared against a chest strap. Oura and Whoop offer detailed data but require subscriptions.” * * *
    • “Oura requires a $6-a-month subscription. Stop paying and it locks up your biometrics, leaving you with basic three-score feedback (sleep, readiness and activity). Whoop doesn’t charge an upfront hardware cost but there’s a mandatory membership starting at $199 a year. And the accessories—bra, shorts, etc.—aren’t cheap.
    • “That still isn’t a lot to pay if you can get off the couch and build lasting change. But if you want data without a monthly fee, the pricier Apple Watch will provide it. And you can skip the Google Health $10-a-month premium plan and still use the Fitbit. 
    • “Living a healthy life is easy in theory but hard in practice. I welcome wearables steering me toward good choices, and decided the Oura Ring plus an Apple Watch is still the best combo for me. After a decade and a half of tracking my fitness, I’ve settled on using these devices to identify long-term trends and help me build better habits. Yet no matter how smart and capable they’ve become, they still can’t replace my own body’s intuition.”

Midweek Update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, No Surprises Act, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

“Simplicity is not about doing less; it’s about focusing on what matters most. The future of performance management is about creating value with clarity & ease.”

From Washington, DC,

  • BioPharma Dive reports,
    • “A bipartisan House bill proposed Tuesday would require government screening of U.S. investments in Chinese biotechnology in the wake of two pharmaceutical deals potentially worth more than $10 billion each.
    • “Reps. John Moolenaar, R-Mich., chairman of the Select Committee on China, and Debbie Dingell, D-Mich., are sponsoring the bill, dubbed the Biotech Investment National Security Act. It would amend the COINS legislation passed last year to restrict investment in certain sensitive technologies, adding biotechnology to the list.
    • “Under the new bill, licensing deals, joint ventures and equity investments in China could be subject to both Treasury and Defense Department reviews. Moolenaar and Dingell focused on licensing deals involving technology and intellectual property and excluded agricultural biotechnology, industrial fermentation and basic academic research.”
  • Federal News Network relates
    • “Close to 8,000 career federal employees will be moved into a new employment category with limited job protections, after the Trump administration took the final step to make Schedule Policy/Career a reality.
    • ‘An executive order President Donald Trump signed Wednesday afternoon formalizes the long-expected federal employment classification and eliminates civil service protections for thousands of senior-level positions across government. The move is meant to boost workforce accountability, but has also drawn sharp criticism from federal unions, employee organizations and other stakeholders.
    • “Trump administration officials said the creation of Schedule Policy/Career aims to improve employee accountability and ensure the federal workforce is carrying out the president’s policy agenda. Officials also said it’s currently too difficult to remove federal employees for poor performance.
    • “It’s also about a restoration, in our mind, of the democratic process,” Office of Personnel Management Director Scott Kupor told reporters during a press call Wednesday. “What Schedule Policy/Career does is really nothing new. This is exactly the way the system worked for a very long time … In order to affect the policy priorities of the administration, we need to have people willing to and capable of carrying out those directives.” * * *
    • “The targeted 8,000 career federal positions for the new classification is far lower than OPM’s initial estimate that Schedule Policy/Career would cover about 50,000 positions. Some earlier estimates had also suggested as many as 200,000 positions could be converted.”
  • Govexec tells us,
    • “With one protest withdrawn and a second one denied, the Office of Personnel Management is now free to move forward with its plan to award a 10-year contract to modernize the government’s human resource systems.
    • “OPM released the final solicitation in October for the Federal HR 2.0 contract to modernize systems that cover 2 million employees across the government. The agency wants a single integrated platform that will be the infrastructure for a more data-driven federal HR ecosystem, according to solicitation documents.
    • “Bidders had to submit proposals by Oct. 31 and OPM followed a two-step process for evaluation. After step one, IBM Corp. and then Economic Systems Inc. filed their protests.
    • “IBM filed its protest on Feb. 25 but withdrew without explanation on April 3. Meanwhile, Economic Systems filed a protest on March 2. On Monday, the Government Accountability Office posted on its public docket that it had denied Economic Systems protest.
    • “OPM could not make an award while the protests were active, but it could continue to evaluate proposals. Now it can pick a winner with the protests out of the way.
    • ‘While no dollar value has been disclosed, the undertaking is massive.”
  • Kevin Moss, writing in Federal News Network, encourages federal employees to take a look at joining FEHB and PSHB high deductible plans that allow them to contribute to triple tax deductible health savings accounts.

From the Food and Drug Administration front,

  • U.S. News and World Report reports,
    • “Acting U.S. FDA Commissioner Kyle Diamantas met ⁠with ⁠rare disease groups on Wednesday, according to groups ⁠attending and a government official, as the new chief seeks to repair relations with a sector disappointed ​by his predecessor.
    • “Representatives for rare disease organizations including Friends of Cancer Research and the Foundation for Angelman Syndrome Therapeutics are pushing Diamantas for greater certainty and support ‌for treatments for small patient populations, the ‌groups said.
    • “The acting chief is seeking to steady operations and mend fences following Commissioner Marty Makary’s resignation last month. Makary had clashed with the White ⁠House over issues including ⁠vaping products.
    • “Jeff Allen, CEO of Friends of Cancer Research, in a phone interview with Reuters ​following the meeting, described it as a “breath of fresh air.”
  • MedTech Dive relates,
    • “Edwards Lifesciences said it has secured FDA approval for the first surgical valve replacement designed for patients with tricuspid valve disease.
    • “The approval introduces a surgical option for a long-underserved area of structural heart care, extending Edwards’ Resilia tissue technology to the tricuspid position, a spokesperson told MedTech Dive in an email. 
    • “Called Triformis Resilia, the valve has a flattened sewing ring shape that mirrors the native tricuspid valve’s annulus anatomy.”

From the judicial front,

  • STAT News reports,
    • ‘A fourth major health insurer is suing HaloMD over its use of the No Surprises Act’s arbitration process, arguing that the middleman deceived arbitrators by sending them a “sham letter” and misleading price data. 
    • “Highmark Health, a Pennsylvania-based Blue Cross Blue Shield licensee with over 7 million members, claims in a complaint filed June 1 in U.S. District Court in Western Pennsylvania that HaloMD and one of its clients, a neuromonitoring provider called Bromedicon, submitted more than 450 ineligible disputes with the company and won more than $3.9 million. Like the three Blue Cross plans before it, Highmark wants those awards tossed and its money returned.” * * *
    • “Other insurers have so far gotten chilly receptions to their suits. Judges in California and Texas have dismissed similar lawsuits against HaloMD and its provider clients, finding their allegations — that the company deliberately submitted ineligible disputes and won huge payouts anyway — didn’t warrant the court’s review. The rulings don’t bode well for Highmark or outstanding cases in Georgia and Ohio.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Eating a diet high in ultraprocessed foods is associated with an increased risk of dementia, according to new research, adding to the growing list of health problems linked to foods such as packaged cookies, hot dogs and chips.
    • “In a study published Wednesday in the American Journal of Public Health, the group of people who reported eating the highest amount of ultraprocessed foods had a 58% higher risk of later developing dementia and a 46% increased risk of developing cognitive impairment than those who said they ate the least.” * * *
    • “Nutrition researchers generally define ultraprocessed foods as items containing ingredients that wouldn’t generally be found in a home kitchen, such as emulsifiers—used to improve the texture of food—and high-fructose corn syrup. 
    • “The new study found that diets high in minimally processed foods, such as fresh fruits, vegetables, whole grains, fish and unprocessed meats, were linked to a decreased risk of dementia and cognitive impairment. People who ate the most minimally processed foods had a 41% lower risk of dementia compared with those who ate the least.”
  • and
    • “New research suggests anesthesia may be closer to being in a coma than previously thought, not just a deep sleep.
    • “Researchers compared brain-wave data from anesthetized patients with those awake, asleep or in a coma.
    • “Understanding these brain patterns could help redesign anesthesia to resemble natural sleep, reducing postoperative issues, experts say.”
  • MedPage Today relates,
    • “Deaths of despair — fatalities from drugs, alcohol, and suicide — declined by 16% in 2024, according to a report from Trust for America’s Health.
  • and
    • “Weight loss is known to reduce the need for joint replacement surgery in overweight or obese people with knee osteoarthritis (OA), and glucagon-like peptide-1 (GLP-1) receptor agonists are an established way to lose weight.
    • “This study of health records demonstrated that use of GLP-1 drugs was associated with reduced arthroplasty rates, with longer exposure leading to correspondingly lower rates.
    • “Reasons for initiating GLP-1 drug therapy were not known, however, and weight loss was not tracked over time, so the mechanisms underlying the observed associations remain unknown.”
  • Gastroenterology Advisor tells us,
    • “A baseline colonoscopy among individuals aged 40 to 49 years is associated with a significantly reduced risk for colorectal cancer (CRC), especially for men aged 45 to 49 years, according to study results published in the American Journal of Gastroenterology.” * * *
    • “These findings provide large-scale observational evidence that the risk-reducing association of an early baseline evaluation becomes increasingly apparent over several years of follow-up,” the study authors stated.”
  • Health Day notes,
    • “Scientists may be one step closer to staging Alzheimer’s disease with a simple blood test.
    • “The test could offer a cheaper, less invasive alternative to brain scans and spinal taps now used to diagnose and determine the extent of disease.
    • “Researchers developed a model that uses just two forms of tau protein in the blood to track Alzheimer’s progression. They tried it on more than 1,000 patients, including people who were cognitively unimpaired, patients with mild cognitive impairment, patients with Alzheimer’s dementia and people with other neurodegenerative diseases.
    • “The result: Staging from the blood model closely matched the accuracy of PET brain scans.”
  • and
    • “Population-based screening for early-stage type 1 diabetes identifies most children who progress to clinical type 1 diabetes, with additional cases detected with repeat screening, according to a study published online May 21 in the Journal of the American Medical Association.”

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

  • Beckers Payer Issues reports,
    • “Cigna will stop covering GLP-1s for weight loss through its own employee health plan July 1, the company confirmed to Becker’s.
    • “We regularly review our health benefits to ensure they remain sustainable, accessible and aligned with the unique needs of our workforce. As availability has increased and new options have emerged, we’ve made the decision to end our plan’s coverage for GLP-1s for weight loss,” a company spokesperson said. “We remain committed to supporting our employees’ health through a range of weight-management programs and resources.”
    • “The change will not apply to those using GLP-1s for diabetes, the spokesperson said. It also will not apply to Cigna plans beyond its own, a spokesperson confirmed to Reuters, which first reported the development June 2. GLP-1 users for weight loss have until June 30 to obtain refills. 
    • ‘An internal document reviewed by Reuters said employees can pay for these drugs with cash directly through manufacturer websites or TrumpRx. However, that spending would not count toward deductibles. Cigna will continue to cover generic weight-loss drugs that predate GLP-1s, such as phentermine, diethylpropion, benzphetamine and phendimetrazine, according to Reuters.
    • “Cigna joins a wave of healthcare employers cutting back GLP-1 access for their workers as cost pressures mount.”
  • The Wall Street Journal provides “Five Takeaways From the WSJ’s Autism Billing-Abuse Investigation — Insurers’ fraud warnings, a nearly $1 million surprise therapy bill and the back story of a visit to the Brooklyn-based provider the Perfect Child.”
  • MedTech Dive relates,
    • “Medtronic ended its fiscal year on a high note, growing revenue by nearly double digits in its fiscal fourth quarter.
    • “The medtech company brought in $9.8 billion of revenue in the quarter, representing year-over-year growth of nearly 10%. The performance was better than expected, J.P. Morgan analyst Robbie Marcus said in a note to investors.
    • CEO Geoff Martha said Medtronic delivered its strongest annual top-line growth in 10 years.
    • “Through a dynamic macro environment, we have executed, and we’ve executed with discipline to deliver an excellent fiscal ’26 that will continue into fiscal ’27,” Martha told investors Wednesday morning.
    • “The performance was driven by solid sales for its cardiovascular unit and strong growth for businesses within the segment.”
  • The Wall Street Journal inform us,
    • “Eli Lilly LLY signed a collaboration and licensing agreement worth up to $1.9 billion with Ascidian Therapeutics to research and develop kidney-disease treatments.
    • “Ascidian, a Boston-based biotechnology company, said Wednesday it granted Eli Lilly exclusive, target-specific rights to its RNA-exon-editing technology for undisclosed kidney-disease targets.
    • “The RNA-exon editors are capable of altering parts of genetic code to repair genetic instructions that cause disease.
    • “Ascidian said it will lead discovery and certain preclinical activities, while Eli Lilly will be responsible for other preclinical work, clinical development, manufacturing and commercialization.
    • “Ascidian is eligible to receive up to $1.9 billion, including an upfront payment, development and commercial milestone payments, and tiered royalties on commercial sales worldwide, it said.”
  • Fierce Healthcare tells us,
    • “Mayo Clinic plans to develop and deploy a frontier AI model specifically designed for healthcare in collaboration with Microsoft. 
    • “The strategic collaboration combines Mayo Clinic’s global healthcare expertise, de-identified clinical health data and longitudinal insights with Microsoft’s advanced AI, cloud engineering and tech capabilities, the companies announced Tuesday.
    • “The two organizations say they are developing a frontier AI model “capable of supporting the broadest scope of clinical reasoning and healthcare use cases,” according to a press release.
    • “The frontier AI model is designed to synthesize diverse clinical data to support earlier diagnoses, more personalized treatment decisions and better patient outcomes. The AI collaboration will make Mayo Clinic’s medical expertise and integrated model of care available to more people when and where they need it, the two organizations said.”
  • Beckers Hospital Review adds,
    • “Washington, D.C.-based Children’s National Hospital has introduced a pediatric AI innovation hub to translate the technology from concept to bedside use.
    • “The partnership with Blacksburg-based Virginia Tech will bring together pediatric clinicians, biomedical researchers and AI specialists to create advancements for what has been an underserved community thus far in the technology’s evolution.
    • “Children have historically been underrepresented in AI research despite having fundamentally different physiology, disease patterns and developmental needs,” said Marius George Linguraru, director of AI research at Children’s National, in a June 2 news release. “We have an opportunity to build pediatric AI the right way from the beginning by developing and validating these technologies specifically for children and within pediatric clinical settings.”
  • Fierce Pharma points out,
    • “Pharma solutions firm Cencora and Gilead Sciences have expanded their longstanding partnership, cutting a deal in which the distribution giant will support access to Gilead’s CAR-T cancer therapies Yescarta and Tecartus.
    • “The collaboration is designed to facilitate more efficient access to the blood cancer therapies, which were developed by Gilead’s CAR-T subsidiary Kite Pharma. 
    • “Under the agreement, Cencora will leverage its substantial distribution infrastructure to bolster cell therapy availability at an “increasing number” of authorized U.S. treatment centers, including health systems and community oncology practices, according to a June 2 release.” 
  • HR Dive lets us know,
    • “Workers over age 55 make up almost a quarter of the workforce (23.2%), according to a report from MyPerfectResume. Moreover, according to researchers, the growth of the older workforce outpaces the general workforce. Likewise, the share of workers over age 65 increased by more than 40%, according to the report.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports on this week’s anticipated activities on Capitol Hill.
    • “After a weeklong recess, Senate Republicans return Monday with their focus set on ways to move their budget reconciliation package, which hit several hurdles before the Memorial Day break. 
    • “The House, which has been on standby while Senate leadership works out how much of the White House wishlist they can salvage, is returning later this week, with its first vote scheduled for Wednesday.”
  • The Wall Street Journal adds,
    • “The Trump administration signaled a retreat Monday on its nearly $1.8 billion “anti-weaponization” fund, which met powerful pushback from members of Congress and threatened to derail the president’s efforts to pass immigration-enforcement funding.”
  • Yesterday, the FEHBlog described OPM’s family member documentation guidance as an interim final rule because OPM had not issued a proposed rule. However, it turns out that OPM decided that public comment was unnecessary so it declared the guidance to be a final rule. The final rule will be published in the Federal Register tomorrow which means that the final rule’s effective date is July 2, 2026.
  • Federal News Network also relates,
    • “Agencies will soon be able to pay as much as $400,000 a year to certain employees with skillsets in the national security sector. President Donald Trump told the Office of Personnel Management on Friday to establish new regulations to pay experts in specific fields related to supply chain resilience, secure access to critical minerals and advanced technologies and advance priority investment programs essential to national defense and economic security. The memo said this increase in the top line pay for these positions is necessary to advance the rapid recruitment of the exceptionally skilled investment, engineering, financial and legal professionals needed to expand the nation’s capacity.”
  • Govexec notes,
    • “For the second straight month, each portfolio offered by the federal government’s 401(k)-style retirement savings program finished May in the black.”
  • The final rule making changes to the No Surprises Act’s independent dispute resolution process is scheduled to be published in the Federal Register on June 4, 2026.
  • Radiology Business tells us,
    • “Radiologists, anesthesiologists and emergency medicine physicians are jointly praising recently announced changes to the No Surprises Act while also pushing for further reform. 
    • “Medical societies representing all three specialties shared their official response to the independent dispute resolution, or IDR, final rule on Friday. Released by the Centers or Medicare & Medicaid Services May 28, the rule finalizes many updates to the NSA first proposed back in 2023.
    • “The American College of Radiology, American Society of Anesthesiologists and the American College of Emergency Physicians commended the rule, calling it a “thoughtful and collaborative approach.” They see the changes as an “important step forward,” one that will hopefully create a “more functional, transparent dispute resolution system.” 
  • These comments confirm the FEHBlog’s opinion that a follow up rule or perhaps a statutory change is needed to level the IDR process playing field which currently favors this healthcare providers.
  • The American Hospital Association News informs us,
    • “President Trump signed an executive order May 29 that directs the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices to review a scientific assessment by the Department of Health and Human Services on childhood vaccine recommendations from other developed nations. The order recommends the CDC and ACIP take any appropriate steps to update the U.S. childhood and adolescent vaccine schedule to align it with those from other nations. The administration also recommended that all immunizations on the schedule should continue to be covered without cost sharing by private insurers and covered by Medicaid, the Children’s Health Insurance Program and the Vaccines for Children Program.”
  • and
    • “The Centers for Medicare & Medicaid Services June 1 issued an interim final rule with comment period implementing the statutory requirement that certain adult Medicaid enrollees meet community engagement (work) requirements. Under the rule, certain adults must complete 80 hours per month of “qualifying activities,” such as employment, education, community service or participation in a work program, or meet equivalent income thresholds.
    • “CMS said that states must generally implement the requirement no later than Jan. 1, 2027. The rule maintains exemptions for certain populations, including individuals who are pregnant or postpartum, disabled or medically frail, or caregivers, and allows states to offer exemptions for short-term hardships. See the CMS fact sheet for more details.
    • “Provisions in the rule are effective on July 31, 2026, and comments must be submitted by that date.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA approved the oral antiviral agent ensitrelvir (Xocova) to help prevent COVID-19 in people ages 12 years or older who were exposed to the SARS-CoV-2 virus, drugmaker Shionogi announcedopens in a new tab or window.
    • “Ensitrelvir is a SARS-CoV-2 main protease inhibitor also approved in Japan as COVID-19 postexposure prophylaxis (PEP) and as a treatment for mild to moderate COVID. The drug is not approved to treat COVID-19 in the U.S.
    • “The FDA’s decision was based on the phase III SCORPIO-PEP trial, which showed the risk of getting sick from a household contact with COVID-19 dropped by more than half among those who took ensitrelvir compared with placebo.”
  • Contemporary OB/GYN relates,
    • “Wockhardt has announced that the FDA has approved cefepime and zidebactam (ZAYNICH; Wockhardt), a novel intravenous antibiotic designed to treat adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. The approval offers a new therapeutic option for patients facing aggressive, drug-resistant infections. Prior to this approval, the drug received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
    • “In the United States, cUTIs are responsible for over 600,000 hospitalizations annually. A growing proportion of these infections are driven by antimicrobial-resistant bacteria, which represent a leading cause of bacteremia and carry significant morbidity and mortality risks. These multidrug-resistant infections place a heavy burden on the healthcare system, as affected patients typically require more intensive, prolonged care and experience higher rates of life-threatening complications.
    • “The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of ZAYNICH is a monumental step forward in validating a new option for these underserved populations,” said Dr. Dennis Deruelle, Chief Medical Officer at Wockhardt.”

From the judicial front,

  • CMS posted a notice of a court decision that will appear in tomorrow’s Federal Register,
    • SUMMARY: This is to inform the public that, on October 22, 2025, the United States District Court for the Southern District of Mississippi issued an order in Tennessee v. Kennedy, No. 1:24-cv-161-LG-BWR (S.D. Miss. Oct. 22, 2025), vacating portions of the final rule titled “Nondiscrimination in Health Programs and Activities,” published May 6, 2024 (89 FR 37522).
    • Specifically, the court vacated certain provisions of the regulation to the extent they expand Title IX’s definition of sex discrimination to include gender-identity discrimination. Pursuant to the court’s order, the vacated provisions are legally void. The other provisions of the Section 1557 Rule remain in force.
    • DATES: The Tennessee court issued its vacatur order on October 22, 2025. As long as the specified provisions of the 2024 Section 1557 Rule remain vacated, OCR and CMS cannot and will not enforce the vacated provisions.

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “An outbreak of a rare strain of Ebola in the Democratic Republic of Congo is already the third largest in history, just weeks after it likely began.
    • “It is spreading rapidly in one of the most volatile and vulnerable regions of the world, worrying U.S. and international health officials.” * * *
    • “What are the chances that Ebola will spread to the U. S.?
    • “The risk is low, according to the Centers for Disease Control and Prevention. U.S. officials have prohibited foreigners who have been to Congo, Uganda or South Sudan in the last three weeks from entering the country. U.S. citizens who have been to those countries are being directed to four U.S. airports and screened there, the CDC said. Those airports are: Washington-Dulles International, Hartsfield-Jackson Atlanta International, George Bush Intercontinental and John F. Kennedy International.
    • “The U.S. has a network of specialized treatment centers around the country to care for patients with dangerous pathogens like Ebola and hantavirus, at hospitals such as the University of Nebraska Medical Center and Emory University Hospital. However, U.S. authorities evacuated an American medical missionary who contracted Ebola in Congo to a hospital in Germany with similar capabilities, and aim to build an Ebola quarantine and treatment facility in Kenya. A Kenyan high court put the U.S. plan on hold.”
  • The American Medical Association lets us know what doctors wish their patient knew about lupus.
    • “Lupus is a complex autoimmune disease with varied symptoms. Early diagnosis and ongoing care can help patients manage flares and protect long-term health.”
  • MedPage Today relates,
    • “The cigarette smoking rate among U.S. adults dropped to another all-time low last year, with one in 11 adults saying they were current smokers, according to new government survey data.
    • “Cigarette smoking is a risk factor for lung cancer, heart disease, and stroke, and it’s long been considered the leading cause of preventable deathopens in a new tab or window.
    • “The preliminary findingsopens in a new tab or window from the CDC were based on survey responses from more than 24,200 adults. In the survey, CDC officials defined current cigarette smoking as smoking at least 100 cigarettes in a lifetime and now smoking every day or some days.” * * *
    • “In 2024, the percentage of current adult smokers fell below 10% for the first time. Last year, it was 9%, according to the new survey.
    • “The use of electronic cigarettes has been inching up among adults, but has held about steady in 2025, at about 7%.”
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) today announced that its Investigational New Drug (IND) application for mitragynine, the primary psychoactive compound found in Mitragyna speciosa (kratom), has taken effect with the U.S. Food and Drug Administration (FDA). The IND paves the way for an NIH-led phase I clinical trial to evaluate mitragynine as a potential treatment for opioid use disorder.
    • “Researchers at NIH and the University of Florida developed the purified formulation of mitragynine to be used in the trial, as well as the preclinical work that led to the submission of the IND application.
    • “This IND is a major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder, which has contributed to historically high overdose mortality rates,” said Nora Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA).”
  • The American Journal of Managed Care tells us,
    • “People living with alopecia areata (AA) may not face a heightened risk of skin cancer despite reduced scalp hair coverage, according to a new systematic review and meta-analysis that found a significantly lower incidence of melanoma among this patient population.
    • “The analysis, published in Frontiers in Oncology, evaluated data from more than 860,000 patients across 8 retrospective studies conducted in the US, Sweden, Denmark, Taiwan, and the Republic of Korea. Researchers reported that AA was associated with a statistically significant reduction in melanoma incidence, whereas rates of basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and overall skin cancer also trended lower but did not consistently reach statistical significance.
    • “The findings arrive as clinicians increasingly prescribe Janus kinase (JAK) inhibitors for moderate to severe AA, raising questions about long-term malignancy risks and the need for baseline disease-specific cancer data.”
  • Fierce Pharma informs us,
    • “AstraZeneca is polishing the case for its Imfinzi (durvalumab) and Imjudo (tremelimumab) combo in liver cancer with a new phase 3 readout from its Emerald trial program assessing the immunotherapy duo in a locoregional setting. 
    • “The phase 3 Emerald-3 study, presented June 1 at the Annual Society of Clinical Oncology (ASCO) 2026 annual meeting in Chicago, positions AZ’s Imfinzi/Imjudo regimen as a “compelling therapeutic option” for patients with unresectable embolization-eligible hepatocellular carcinoma (HCC), ASCO expert Vishwanath Sathyanarayanan, M.D., commented in an ASCO press release.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The public and private sector are committed to value-based care as a solution to high healthcare spending.
    • “Decades of value-based care interventions have not reversed perpetually rising health expenditures.
    • “UnitedHealth Group, CVS Health and other companies have made value-based care central to their business plans.
    • “The fragmented healthcare system remains an obstacle to cost containment.”
  • Beckers Hospital Review relates,
    • “Orlando (Fla.) Health recorded an operating income of $47.4 million (1.9% operating margin) in the second quarter of 2026, down from $94.7 million (3.9% margin) during the same period last year, according to its May 26 financial report.”  
  • KFF Health News, writing in Fierce Healthcare, tells us,
    • “Most patients who have taken a GLP-1 received their prescription through a primary care doctor or a specialist, KFF polling data shows. But as the uptake of telehealth has grown substantially since the start of the covid pandemic, * * * millions of Americans who have used online companies to meet a variety of their medical needs.
    • “Many of the companies have started offering GLP-1 medications for weight loss as demand for these drugs has exploded. But certain medication errors tied to GLP-1s have exploded too, according to a KFF Health News review of Food and Drug Administration data, and physicians and telemedicine researchers worry that adverse experiences tied t”o telehealth companies are becoming more common.
    • Bad outcomes aren’t unique to telehealth providers or to the compounded weight loss drugs many of them offer. In fact, product liability lawsuits alleging patient injuries have been filed overwhelmingly against pharmaceutical giants Eli Lilly and Novo Nordisk, which manufacture name-brand weight loss drugs, court data shows. The drugmakers have defended their products.
    • “However, some critics are also concerned that getting a weight loss prescription online is usually much easier than getting one through an in-person appointment. Not only do many telehealth companies write quick prescriptions for GLP-1s, but they often sell the medications, too, allowing patients to bypass in-person pharmacy visits. This one-stop shopping isn’t necessarily a good thing, according to critics who say some telehealth providers are writing prescriptions for people who should not be taking GLP-1s and then providing little or no follow-up care.
    • “It gives a black eye to telemedicine,” said Elizabeth Krupinski, an experimental psychologist at Emory University who has conducted research on the effectiveness of telehealth.”
  • Fierce Healthcare informs us,
    • “Weight loss company Noom is offering an at-home biomarker testing kit for its U.S. members, expanding its platform into diagnostics and metabolic health monitoring.
    • “It marks an expansion of the company’s proactive health program, which rolled out in December, offering microdose GLP-1 medications combined with at-home biomarker testing and insights.
    • “The at-home blood collection and lab testing service enables members to establish baseline labs and track improvements in markers such as, HbA1C, ApoB, triglycerides and hs-CRP over time, according to the company. Testing gives users with insights into biological outcomes, such as blood sugar regulation, lipid profiles and inflammation markers. By using the kit, members can skip a lab visit and receive results within about a week, paired directly with access to medication and behavior change programs, according to executives.
    • “Noom says it now provides a platform where members can test, act and track A1C improvement in a single, integrated experience.
    • “The biomarker test kits cost $125.”
  • Fierce Pharma points out,
    • “In its seventh week on the market, which ended May 22, Eli Lilly’s obesity pill Foundayo continued to track below the pace of Novo Nordisk’s rival Wegovy pill at the same point in its launch.
    • “At the same time, analysts at Jefferies and Citi again flagged caveats that could be skewing the numbers, with the Jefferies team espousing confidence that Lilly’s oral GLP-1 can still meet consensus sales projections for both the second quarter and 2026 as a whole. 
    • “Breaking down the numbers, the Jefferies team put seventh-week total Foundayo prescriptions lower versus the previous week at roughly 11,700, with the clarification that the data’s source, IQVIA, had to use a “best-estimate” tally for the latest week’s prescription trends. 
    • “That trend remains “numerically lower” than the course charted by Novo’s Wegovy pill, which racked up an impressive 67,000 prescriptions in its seventh week, although Foundayo’s performance still tracks ahead of Novo’s injectable Wegovy and Lilly’s first obesity incretin med Zepbound at the same point in their respective rollouts, the analyst team said.” 

Thursday report

David Ermer–CDC, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Mental health care, No Surprises Act, Obesity, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The departments of Health and Human Services, Labor and the Treasury [and the Office of Personnel Management] issued a final rule May 28 intended to improve the functioning of the No Surprises Act (NSA) independent dispute resolution process. The rule streamlines communication between payers, providers and certified IDR entities and clarifies timelines and processes. It improves the functionality of the IDR process by finalizing various changes, including allowing up to 50 items and services to be batched in the same payment dispute. The final rule also increases access to the IDR process by reducing the administrative fees associated with it. The AHA supported many of these changes in comments on the proposed rule.”
  • The rule decreases the federal government fee for handling an NSA arbitration from $115 per party to $15 per party. The FEHBlog expects the arbitrators’ fees to increase accordingly over time. No good deed, etc.
  • The FEHBlog also expected the final rule to include an administrative remedy that would allow providers and payers to enforce or challenge arbitration awards.
  • The FEHBlog agrees with AHIP’s comments on the final rule.
    • “While the focus on addressing flawed incentives in the IDR process is a significant first step, more action is needed to protect Americans from unconscionable price gouging by some PE-backed providers and IDR middlemen.” – Chris Bond, AHIP spokesman”
  • Tammy Flanagan, writing in Govexec, discusses “[w]hat retiring feds should do before asking for help.
    • “Clear timelines, complete records and focused questions can make retirement problems easier to resolve, especially as agencies face mounting workloads.”
  • Federal News Network tells us,
    • “The Postal Service is putting immediate restrictions on nonessential spending to avoid running out of cash sooner than expected.
    • “Postmaster General David Steiner wrote in a memo Tuesday that the restrictions will impact hiring, travel and training as well as other areas of spending. Departments within USPS may be asked to provide a summary of “cost-containment actions taken and expected savings.”
    • “Steiner told members of the House Oversight Committee in March that USPS will run out of cash in early 2027, as long as it continues to pay its bills on time. But USPS is relying on some emergency measures to conserve cash.
    • “As you are aware, we are currently experiencing a temporary cash-flow shortage that requires us to take decisive steps to manage our available resources responsibly,” Steiner wrote in the memo. “To protect core operations and ensure that we can continue meeting all essential obligations, we are implementing immediate restrictions on non-essential spending across all departments.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA’s vaccine advisors voted 8 to 0, with one abstention, in favor of a monovalent XFG vaccine for COVID-19 shots for the 2026-2027 season.
    • “The Vaccines and Related Biological Products Advisory Committee (VRBPAC) also discussed the need to target the long-simmering BA.3.2 variant, also known as “cicada,” though most expressed confidence that targeting XFG was the right way to go.
    • “The XFG variant is the most common variant in the U.S. right now, and looking at the other JN.1 variants that may be coming up, I still think that the BA.3.2 variant is not as common. I think we have to keep surveillance very vigilant though,” said Anna Durbin, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, adding that the “immunogenicity of the vaccines looks good, so I was very comfortable voting yes.”
  • Fierce Pharma relates,
    • “AstraZeneca has fired another volley in its bladder cancer competition with Merck’s Keytruda, with the FDA on Thursday clearing its PD-L1 inhibitor Imfinzi as part of the first immunotherapy combo regimen in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who haven’t previously received standard of care Bacillus Calmette-Guérin (BCG) treatment. 
    • “The green light clears Imfinzi in the indication alongside BCG induction and maintenance therapy, AZ said in a May 28 release. 
    • “This marks the second recent bladder cancer nod for Imfinzi, which was approved in March of last year in muscle invasive bladder cancer (MIBC), in that instance in combination with the chemotherapies gemcitabine and cisplatin ahead of bladder-removing surgery and then on its own following the procedure.”
  • and
    • “As AbbVie continues to capitalize on its ImmunoGen deal, the growth of commercial antibody-drug conjugate (ADC) Elahere, another of the acquired company’s clinical assets has crossed the FDA finish line. 
    • “The FDA on Wednesday announced the approval of AbbVie’s CD123-direct ADC pivekimab sunirine-pvzy, which will hit the market under the Decnupaz moniker, as a treatment for adults with the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN). 
    • “The condition is a rare and aggressive cancer of the bone marrow and blood that can also affect organs like the lymph nodes, spleen and skin. Most patients with BPDCN present with purple-colored skin lesions and the malignancy is often diagnosed in more men than women, with most patients aged 60 years and older.” 
  • Health Exec tells us,
    • “The U.S. Food and Drug Administration (FDA) said it’s aware of an issue with IV tubes, where black matter has been found within the walls of the plastic walls, signaling a contamination issue.
    • “ICU Medical said samples containing the particulates are being returned for analysis to help identify the problem. Until then, the devices are being removed from use and distribution.
    • “Typically sterile, these tubes are used to connect medication and fluid bags to patients, as administered through an IV line.
    • “ICU Medical and the FDA said in an announcement this could be a potentially high-risk issue, though there was no mention of patient injuries. The FDA described the notice as an early alert regarding a potential safety issue.”

From the judicial front,

  • Modern Healthcare reports,
    • “Clover Health won a lawsuit [in the U.S. District Court for the Southern District of Georgia] challenging its 2026 Medicare Advantage star ratings.
    • “A federal court ruled that 20 quality measures the Centers for Medicare and Medicaid Services used are improper.
    • “The decision could have industrywide implications because CMS rated all Medicare Advantage insurers on those metrics. 
    • “CMS filed a motion to reconsider the ruling.

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention today released a report highlighting data on patients hospitalized during a 2025 measles outbreak centered in West Texas. There were 762 confirmed cases during the outbreak, which lasted from late January through mid-August 2025. The report found that of the 60 hospitalized patients, nearly 91% were children and adolescents under age 18 and nearly 56% were age 4 or younger. Additionally, 4 out of 5 hospitalized adults age 18-44 were pregnant women in their third trimester. Available medical records of 54 patients were reviewed. All 54 were found to be unvaccinated or had an unknown vaccination status.”
  • Healio relates,
    • “Measures of ideal heart health including healthy levels of physical activity, BMI, BP and sleep were associated with lower risk for severe COVID-19 among people with no history of heart disease during the pandemic, researchers reported.
    • “For every 1 standard deviation increase in total American Heart Association’s Life’s Essential 8 score, individuals without prior CVD experienced an approximately 20% reduced risk for severe COVID-19 infection, according to data published in the Journal of the American Heart Association.”
  • Health Day adds,
    • “Being incredibly fit shouldn’t increase a young adult’s risk of dangerous irregular heart rhythm, a new study says.
    • “Young male athletes and fitness buffs aren’t more likely to develop atrial fibrillation, despite earlier studies that showed an apparent link, researchers reported May 21 in the journal Circulation.
    • “Our study shows that there are good reasons to nuance and tone down the message, which has been widespread at times, that high levels of fitness or participating in races would pose a big risk to a person’s cardiovascular health,” said lead investigator Marcel Ballin, an associated researcher at Uppsala University in Sweden.
    • “The risk of atrial fibrillation is certainly not zero, but that said, the benefits are significantly greater,” he said in a news release.”
  • and
    • “Adopting low-insulinemic and planetary health diets during menopause is associated with optimized weight management, according to a study published online May 20 in JAMA Network Open.
    • “Tong Xia, M.D., Ph.D., from Brigham and Women’s Hospital in Boston, and colleagues compared dietary patterns and their associations with weight gain and obesity risk in the years surrounding menopause. The analysis included 38,283 women participating in the Nurses’ Health Study II, with 12-year observations surrounding menopause.
    • “The researchers found that after adjusting for age, race and ethnicity, marital status, income, postmenopausal hormone therapy use, parity, smoking, alcohol, energy intake, physical activity, and baseline body mass index, the reverse empirical dietary index for hyperinsulinemia (EDIH; quintile 5 versus 1) was associated with the largest reduction in weight gain (mean, −0.28 kg/year). The lowest risk for incident obesity was seen with the Planetary Health Diet Index (PHDI; hazard ratio, 0.46) and reverse EDIH (hazard ratio, 0.51). The largest positive correlations in the EDIH were seen with red or processed meats, sodium, and French fries, while for the PHDI, the largest positive correlations were seen with nuts, unsaturated fats, whole-grain carbohydrates, and vegetable protein.” 
  • The Washington Post informs us,
    • Ozempic was supposed to be a gut story. Then Allison Shapiro looked at the brain scans.
    • An assistant professor at the University of Colorado Anschutz, she was part of a team studying 13 teens and young women with a hormonal disorder affecting the ovaries who were put on GLP-1 drugs. As part of testing to catalogue the effect of the medication on their bodies, Shapiro took snapshots of their brains before and after.
    • She was astonished to find extensive changes.
    • Within only a few months, the brain connections in the salience network, which helps target attention, had multiplied.
    • “We didn’t expect to see this effect, and we really don’t know what it means,” Shapiro said.”

  • BioPharma Dive tells us,
    • “An RNA-based shot developed by GSK and Ionis Pharmaceuticals helped wipe out hepatitis B in about a fifth of the patients who received it in a pair of clinical trials, according to study results published Thursday in the New England Journal of Medicine.
    • “Called bepirovirsen, the shot could represent an important advance for people with chronic hepatitis B infections, less than 1% of whom can achieve such a “functional cure” with the help of oral antivirals. None of the participants who received a placebo hit that mark in the two trials presented Thursday.
    • ‘The Food and Drug Administration is already reviewing an approval application for bepirovirsen, and has granted the drug “fast track” and “breakthrough therapy” designations that could speed up its evaluation. An approval decision is expected no later than Oct. 26.”
  • Genetic Engineering and BioTechnology News points out,
    • “Biohub, the non-profit research organization co-founded by Priscilla Chan, MD, and Mark Zuckerberg, has now unveiled the latest update to the ESM protein language model family, with expanded capabilities in binder design and protein function mapping for therapeutic discovery. The release comes just seven months after Biohub recruited the team behind EvolutionaryScale. 
    • “The system includes ESMC (Evolutionary Scale Modeling Cambrian), a language model trained on approximately 2.8 billion sequences drawn from a breadth of life, including organisms adapted to extreme environments, and more than 20,000 types of proteins found in the human body. Evolutionary information encoded in ESMC is translated into atomic-resolution protein structures and interactions using the design engine and prediction model, ESMFold2. 
    • “Alex Rives, PhD, head of science at Biohub and former chief scientist at EvolutionaryScale, presented the work at this week’s “AI in Biology” symposium at Cold Spring Harbor Laboratory.  
    • “These models aim to transform the earliest stages of drug discovery by making biology more programmable. While traditional discovery workflows rely on slow and resource intensive experimental screens to identify promising drug candidates, rational protein design guided by in silico predictions has the potential to dramatically accelerate development timelines. 
    • “We’re at an exciting point in protein biology where accurate digital representations allow asking experimental questions at a scale that wouldn’t be possible in the laboratory,” Rives told GEN Edge.”  

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Highmark Health recovered in the first quarter after reporting losses last year, the health system and insurer announced Thursday.
    • “The Pittsburgh-based nonprofit company reported a 1,308% jump in first-quarter net income to $183 million and a 1,340% improvement in operating income to $216 million. Revenues grew 3.8% to $8.3 billion. Highmark Health lost $175 million in 2025.
    • “Highmark Health Plans’ strategic adjustments in Medicare and Medicaid drove the rebound, Highmark Health Chief Financial Officer and Treasurer Carl Daley said.” 
  • Fierce Pharma relates
    • “The top pharmacy benefit manager (PBM) in the U.S., CVS Caremark, will restore coverage to obesity products from Eli Lilly, allowing a significant number of patients to gain access to the drugs through their existing insurance.
    • “CVS will begin covering Lilly’s GLP-1 pill Foundayo on Monday of next week, June 1, while coverage of Lilly’s injected treatment Zepbound begins on October 1. CVS Caremark, which is the pharmacy chain’s drug benefits unit, is the largest PBM in the country.”
  • and 
    • “CVS Health is growing its partnership with Salesforce, leveraging its agentic AI-driven Agentforce Health to boost personalization in its call centers.
    • “The companies announced on Thursday morning that the platform will connect data across CVS, including Aetna and Caremark, to make it easier for call center teams to address a member’s unique needs in a single interaction when possible.
    • “The Agentforce tool will surface critical insights to call center teams in advance, preparing them more effectively for conversations. The goal, the partners said, is to improve the experience for both the member and the workers through a more streamlined interaction.”
  • OptumRx, writing in Linked In, discusses the four drug classes that drive spending.
    • Inflamatory conditions drugs,
    • Oncology drugs,
    • Diabetes drugs, and
    • Obestty Drugs.
  • Beckers Payer Issues points out,
    • “CVS Health’s insurance branch will roll out “Aetna Mental Health On Demand” in 2027, the company said in a May 28 news release.
    • “Aetna members who are at least 13 years old will be able to access licensed clinicians via chat, phone or video. These professionals are trained on a “single-session intervention model” to drive immediate impact, such as through crisis management. Clinicians can provide a personalized plan, advocate for members, connect them with more resources and help with follow-ups and further care coordination.
    • “The platform also contains integrated AI tools for note-taking and administrative tasks. Clinicians participated in hundreds of chats and were able to respond to members within 13 seconds, the news release said about an initial rollout.” 
  • Healthcare Dive tells us,
    • “Teladoc Health said Thursday it is partnering with Walmart to add its virtual care services to the retail giant’s digital healthcare platform.
    • “With the partnership, Teladoc’s virtual care offerings — including urgent care, dermatology and nutrition support — are now available through Walmart’s Better Care Services platform, which connects customers to third-party digital health providers. 
    • “The deal should put Teladoc’s services in front of more potential patients, Kelly Bliss, president of the company’s U.S. group health business, told Healthcare Dive. “We have the largest nationwide network of virtual care providers in the country, and so we want to activate that network and our clinical services wherever people are making health decisions,” she said.”
  •  and
    • “Amazon’s healthcare leader is stepping down from this summer, and the co-founder of telehealth company Amwell will replace him, the retail and technology giant said Wednesday. 
    • “Neil Lindsay, who became senior vice president of Amazon Health Services in 2021, is leaving to pursue personal projects, he said in a message to Amazon employees.
    • “Dr. Roy Schoenberg, the former co-CEO of Amwell who helped found the telehealth provider two decades ago, will start as new head of Amazon’s health business on July 1. Lindsay will stay on as an advisor to Schoenberg through the end of the year.”
  • Per MedTech Dive.
    • “Ōura plans to roll out a swath of health and wellness features in June, following the launch of its latest smart ring.
    • “Among the new additions will be a tool to track nighttime blood pressure patterns and the ability to view nighttime breathing data over a 30-day period. Ōura announced the features, along with its Ōura Ring 5, on Thursday.
    • “Jason Russell, vice president of consumer software product at Ōura, told MedTech Dive that the blood pressure feature is intended to show trends in overnight changes and the relationship to daily habits, such as sleep, stress and exercise. 
    • “Ōura plans to offer blood pressure signals as a wellness feature, meaning it would not be regulated as a medical device, but there are some limitations on what it can tell users.”  

Tuesday Report

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

Simplicity is a Virtue.

From Washington, DC,

  • USAFacts.org tells us,
    • “Defense Department data shows that 63,670 active-duty military members have passed away since 1980. Eighty-four percent of these deaths were due to accidents, illness, and suicide or self-inflicted wounds. Two-hundred and sixty military members have died from the beginning of 2026 to May 13. Thirteen of these deaths resulted from Operation Epic Fury.
    • “Detailed record-keeping about the ways in which active-duty military members die began in 1980. Historical records from The Department of Veterans Affairs (VA) show that approximately 1.2 million service members died between 1775 and 1991.” * * *
    • “The US global war on terrorism began after Al Qaeda operatives carried out the September 11th attacks. The US invaded both Afghanistan and Iraq in the resulting conflict to remove the regimes of the Taliban and Saddam Hussein from power.
    • “From the onset of military operations in October 2001 to May 2026, the United States has lost 7,073 military personnel in Afghanistan and Iraq. Another 53,560 members have been wounded.” * * *
    • “The US began Operation Epic Fury on February 28, 2026 to dismantle Iran’s security infrastructure. As of May 13, thirteen US service members have died in the operation and 404 have been wounded in action.”
  • May they all rest in peace.
  • Modern Healthcare reports,
    • “U.S. Centers for Medicare and Medicaid Services Administrator Mehmet Oz is reorganizing leadership roles at the agency, a spokesperson told Bloomberg.
    • “Rebekah Armstrong, who currently leads the agency’s office of legislation, will be the new chief of staff, spokesperson Christopher Krepich said. Before joining the administration, Armstrong worked on Capitol Hill, for health insurance lobby group AHIP, and the first Trump administration.
    • “Stephanie Carlton, who had led the agency as deputy administrator and chief of staff, will now be focused on her deputy administrator role, according to Krepich. Her portfolio will include work on clinical artificial intelligence and modernizing Medicaid quality measures, he said.”
  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM) today issued, for public comment, a template non-disclosure agreement (NDA) for federal employees with access to sensitive government information including personally identifiable information, operational plans, personnel records, and other protected materials.
    • “The template NDA comes amid a series of recent unauthorized disclosures involving sensitive government information, including leaks related to planned immigration enforcement operations, disclosures of confidential operational details prior to a US action overseas, and the release of personal information belonging to approximately 4,500 ICE employees, including frontline enforcement personnel.
    • “The template NDA would allow agencies to use standardized confidentiality agreements for covered employees and contractors whose duties involve routine access to sensitive systems or protected information. If finalized, it would become an official government form that agencies could use as a standard part of the employee onboarding process.
    • “In much of the private sector, employees handling sensitive business or customer information are routinely required to sign confidentiality agreements, and the federal government should not be held to a lower standard,” OPM Director Scott Kupor said. “Americans should be able to trust that their personal data and sensitive government information are being handled responsibly. This proposal reinforces accountability across the federal workforce while helping agencies better protect against unauthorized disclosures.” * * *
    • “Read the proposed NDA, and accompanying Federal Register notice, here.” The public comment deadline will occur in late June 2026.
  • The American Hospital Association informs us,
    • “The AHA commented May 26 to the Federal Trade Commission and the Department of Justice on potential changes to the Hart-Scott-Rodino Antitrust Improvements Act’s premerger notification form. The AHA urged the agencies to exclude hospital mergers from any revisions to the form, reiterating its previous position, and said that changes would impose burdens that outweigh any expected benefits. The AHA highlighted how mergers can be important in helping hospitals and health systems overcome financial challenges, and that there has been no indication that hospital mergers have historically evaded FTC review. Additionally, the AHA said that new questions on the form do not weigh in on issues that typically arise in hospital mergers or use language that fits within the context of hospitals.” 

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA’s vaccine advisors will meet Thursdayopens in a new tab or window to vote on whether an XFG monovalent vaccine should be preferred for COVID-19 shots for the 2026-2027 season.
    • “The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will also discuss what circumstances would warrant a non-JN.1 lineage variant — such as BA.3.2, also called “Cicada” — for next season’s vaccines.
    • “In an FDA briefing documentopens in a new tab or window, the agency noted that in the U.S., descendants of the JN.1 variant of Omicron remain prominent and have diversified into multiple lineages, including XFG, NB.1.8.1, and LF.7.”
  • Fierce Pharma relates,
    • “More than three years after Gilead Sciences’ hepatitis D drug bulevirtide was rebuffed by the FDA due to manufacturing and delivery concerns, the treatment has since redeemed itself by scoring a green light in the U.S.
    • “Just before the Memorial Day weekend, the FDA signed off on Gilead’s Hepcludex as the first treatment for chronic hepatitis D virus infection in the United States, granting the entry inhibitor an accelerated approval in adults without cirrhosis or with compensated cirrhosis—a complication of long-term liver inflammation that leads to progressive scarring of the organ.
    • “The FDA cleared the therapy based on data from Gilead’s late-stage MYR301 study, in which Hepcludex helped patients achieve statistically significant improvements in a combined virologic and biochemical response at 48 weeks versus a control group that received delayed treatment, the company explained in a release.” 
  • STAT News adds,
    • “People in the food world didn’t know what to expect when the Trump administration appointed a little-known Florida attorney as the FDA’s top food official in 2025. 
    • “They knew Kyle Diamantas worked at Jones Day representing food, beverage, and tobacco-industry clients. They saw the picture of him and Donald Trump Jr. holding giant, dead wild turkeys after a hunt. He had no experience in public health, in medicine or science, or in government.
    • The credentials didn’t scream qualified. And Diamantas was stepping into a center rocked by DOGE layoffs and a defiant resignation by former leader Jim Jones. 
    • “But more than a year later, leaders in the food industry, public health groups, and FDA career staffers have found that Diamantas exceeded expectations. As Diamantas takes the reins at the FDA, STAT spoke with more than 10 of these stakeholders, as well as former FDA commissioners and Diamantas’ former colleagues. They all described him as thoughtful and serious, someone who does his homework before meetings and listens to the experts in the room. 
    • “Crucially, Diamantas has earned the trust of key career staff. That simple quality was a rarity among top leaders working at former commissioner Marty Makary’s FDA.”

From the public health and medical / Rx research front,

  • Cigna Healthcare, writing in Linked In, points out everyday mental health signs that we overlook and their impact.
    • “Missed early signs show up later with consequences: “Normal stress” that’s dismissed tends to surface downstream in productivity, quality, mistakes, and relationship friction.
    • “Early detection is pattern-based, not crisis-based: Small changes that persist for days often precede visible performance issues and escalation.
    • “Benefits can operationalize early support at scale: Integrated benefits can spot non-obvious patterns and route people to the right support earlier, helping reduce escalation and making costs more predictable.”
  • The American Medical Association lets us know “what doctors want patients to know about pancreatic cancer.”
    • “Pancreatic cancer is a challenging form of cancer. It is notoriously difficult to detect early and often requires treatment across physician specialties.”
  • MedCity News reports,
    • “While conversations around GLP-1s typically center on adults, a new report sheds light on prescribing trends among adolescents and offers recommendations for how employers can manage coverage and care.
    • “The Nomi Health report, shared with MedCity News exclusively, analyzed four years of GLP-1 prescription claims data for adolescents ages 12 to 17 enrolled in a national population of self-insured employer health plans from 2022 through 2025. 
    • “It found that during this time period, GLP-1 adoption among adolescents rose more than 60% and total spend increased 111% from $857,000 to $1.8 million. In addition, scripts per member rose 30%, and cost per member increased 32%.” * * *
    • “Nomi Health provided several recommendations for how employers can act based on these findings:
      • “Analyze adolescent GLP-1 claims across at least four years to gain a better understanding of prescribing and cost trends.
      • “Check that the correct support is in place, such as behavioral counseling and lifestyle support alongside medications.
      • “Plan ahead for the gap. Rising obesity prevalence, coupled with low treatment rates, could drive significant future costs, making it important to model the impact before it becomes a surprise in the budget.”
  • Cardiovascular Business adds,
    • “New research presented at Heart Rhythm 2026 suggests taking GLP-1 receptor agonists (GLP-1-RAs) may reduce the risk of atrial fibrillation (AFib) and improve survival through mechanisms that extend beyond weight loss alone.
    • “Kenneth Bilchick, MD, MS, director of electrophysiology research and a professor of cardiovascular medicine at the University of Virginia, presented those findings at the conference. He then spoke to Cardiovascular Business for a video interview. 
    • “Bilchick said GLP-1 drugs have an anti-inflammatory effect, which may what led to the lower AFib rates in GLP-1 patients.
  • Health Day relates,
    • “Quitting smoking might protect your future brain health, a new study says.
    • “People who quit smoking had a lower risk of developing dementia, especially if they didn’t gain excess weight afterward, researchers reported May 20 in the journal Neurology.
    • “People often worry about what happens after they quit smoking — including weight gain and associated metabolic changes,” said lead researcher Hui Chen, dean of psychological and behavioral sciences at Zhejiang University School of Medicine in Hangzhou, China.
    • “What we found is that quitting is still associated with better brain outcomes but maintaining your weight may help preserve those benefits,” Chen said in a news release.”
  • Genetic Engineering and Biotechnology News notes,
    • “Researchers at Cincinnati Children’s Hospital Medical Center and Nantes Université in France have designed 3D-printed scaffolding trays that will reportedly allow scientists to produce larger versions of functional human gut organoids twice as fast as previous methods—and these organoids grow their own nerve cells.
    • “This improved technology could help accelerate production of human mini-organ tissues that are large enough to be useful in patching damage or restoring diminished functions of a person’s small intestine, stomach, or colon. Such tissues also would be valuable for future disease studies and to more accurately evaluate organ damage risks linked to oral medications, according to the investigators.”
    • Details of the study “Large-scale and innervated functional human gut tissues for transplantation via transient spheroid confinement” appear in Nature Biomedical Engineering.

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

  • The Wall Street Journal reports,
    • “Eli Lilly LLY agreed to acquire three vaccine developers in deals valued at up to nearly $4 billion combined, the company said Tuesday.
    • “The deals mark a new push by the weight-loss drug market leader into infectious-disease prevention.
    • “The details
      • “Indianapolis-based Lilly has agreed to acquire Curevo, LimmaTech Biologics and Vaccine Company, confirming an earlier report in The Wall Street Journal. 
      • “Curevo is developing a shingles vaccine that Lilly believes could be as effective as the current standard but with reduced side effects, said Daniel Skovronsky, Lilly’s chief scientific and product officer. Lilly could pay up to $1.5 billion in cash for Curevo, including an undisclosed upfront payment and a potential subsequent payment if a certain milestone is met. 
      • “LimmaTech is developing vaccines against bacterial pathogens including Staphylococcus aureus. Lilly agreed to pay up to $780 million in cash for LimmaTech, including an undisclosed upfront payment and additional payments for certain clinical and regulatory milestones.
      • “Vaccine Company is developing a vaccine against Epstein-Barr virus. Lilly agreed to pay up to $1.55 billion in cash, including an undisclosed upfront payment and potential clinical and commercial milestone payments.”
  • Fierce Healthcare relates,
    • “Trinity Health is outperforming some of its large Catholic peers, reporting $200 million of operating income (1% operating margin) over the nine-month period ended March 31, 2026, according to a recent filing. 
    • “The tally reflects a 5.4% year-over-year rise in both operating revenue and operating expenses ($20 billion and $19.8 billion, respectively), and is a narrow, $2.1 million improvement over the prior year’s nine-month operating income.” * * *
    • “Trinity’s steady operating gain places the nonprofit ahead of the country’s other 11-figure faith-based systems with offset fiscal years: CommonSpirit Health and Ascension. The former recently disclosed a $743 million adjusted operating loss (-2.4% operating margin) across three quarters, a decline that excludes the substantial on-paper costs of an early contract termination. Ascension’s operations, while broadly on the upswing, also posted a nine-month loss of $203 million (-1.1% operating margin).” 
       
  • Healthcare Dive tells us,
    • “PacificSource Health Plans, a nonprofit health plan offering coverage in four states in the Pacific Northwest, is exiting the Affordable Care Act market next year and ending all operations in Montana.
    • “PacificSource is the latest insurer to flee the exchanges as rising costs and policy turbulence make it more difficult for smaller payers to remain operational.
    • “As a not-for-profit organization, PacificSource is making difficult decisions to ensure we can continue fulfilling our mission and serving members for the long term amid growing pressures across the healthcare industry,” a spokesperson told Healthcare Dive.”
  • Modern Healthcare informs us,
    • “WakeMed Health & Hospitals rejected an unsolicited proposal from UNC Health to combine.
    • “The proposal followed Atrium Health’s May 1 announcement it plans to merge with WakeMed.
    • “A UNC Health spokesperson said the Chapel Hill, North Carolina-based system submitted a proposal to WakeMed for a “broader partnership” May 5.
    • “WakeMed, which is based in Raleigh, North Carolina, reviewed the proposal but felt the partnership with Atrium was the best path forward, a WakeMed spokesperson said. 
    • “Combined, WakeMed and UNC Health would control 80% of the healthcare market in Wake County. We have heard from numerous stakeholders, including the state treasurer, that maintaining robust competition is important for our rapidly growing region,” the WakeMed spokesperson said.” 
  • Per an Institute for Clinical and Economic Review news release,
  • Fierce Healthcare points out,
    • “Health tech companies Wheel and b.well Connected Health are partnering to offer turnkey infrastructure for next-generation AI-first virtual care.
    • “AI-first healthcare experiences and consumer-centered care models are driving innovation in healthcare. Consumer health data is widespread and embedded in daily life, with information available from apps, wearables, devices and medical records. At the same time, retailers and pharmacies are becoming care access points, while life sciences companies are going direct-to-consumers. And the Centers for Medicare and Medicaid Services (CMS) is pushing forward initiatives to open up patients’ access to health data.
    • “Wheel’s partnership with b.well gives AI-native companies, retailers, life sciences companies, payers, health systems and consumer health brands a faster, more complete way to compete in the consumer-driven healthcare race, according to the two companies.”
  • Per MedTech Dive,
    • “Olympus said Tuesday it has agreed to buy Israel-based BioProtect for $270 million to expand its product portfolio in oncology and urology. 
    • “BioProtect makes a balloon spacer system that separates the prostate from other structures during cancer radiation treatment.
    • “The transaction is expected to increase patient access to BioProtect’s technology through Olympus’ global reach and relationships with healthcare providers.”

Friday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, Patient safety, U.S. Healthcare, Uncategorized–

Simplificity is a virtue.

From Washington, DC

  • Roll Call reports,
    • “The House Appropriations Committee advanced a draft fiscal 2027 Legislative Branch spending bill on Wednesday that would slash the budget for the Government Accountability Office by nearly one-quarter and give a boost to Capitol Police.
    • “The party-line vote of 34-28 came after a contentious markup stretching late into the evening, as Democrats argued the GAO cut would undermine its mission.”
  • The Hill informs us,
    • “Federal Reserve Chair Kevin Warsh was sworn in Friday beside President Trump, kicking off his term as the new head of the central bank at a critical time for the U.S. economy.” * * *
    • “Warsh, 56, returns to the Fed board after serving as a member from 2006 to 2011. He was nominated to the Fed by former President George W. Bush, whom he served as a White House economic adviser before becoming the youngest Fed board member in history.
    • A graduate of Stanford University and Harvard Law School, Warsh also worked at Morgan Stanley and served in various academic and advisory roles outside of his government service. 
    • Warsh was most recently a fellow at Stanford’s Hoover Institution, an influential conservative think tank known for its close ties to prominent Republican policymakers.
  • Healthcare Dive relates,
    • “The HHS is continuing its crackdown on healthcare fraud, launching a program that will use artificial intelligence to examine audits from states and other federal grant recipients — and potentially affect Medicaid funds.
    • “The Office of the Assistant Secretary for Financial Resources will look across all states to analyze at least five years of audits that grantees file annually with the federal government, the department said Thursday. 
    • “The agency says past audits include internal control issues and “chronic” noncompliance. If recipients aren’t able to fix those problems, the HHS could temporarily withhold payments, hold back future funds, or suspend or terminate awards.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with updated use instructions. The FDA said that Abiomed identified an issue where if a patient is treated with a left ventricular Impella device and experiences an extended period longer than 80 minutes with no residual pulsatility, the Abiomed Automated Impella Controller may be forced to restart due to an internal software error.” 
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis. Bulevirtide is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis (scarring), liver cancer, liver failure, and even death.
    • “Today’s approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available,” said Wendy Carter, D.O., Acting Director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research. “For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications.”

From the judicial front,

  • Bloomberg Law reports,
    • “The importance of the $885 million antitrust verdict this week against Takeda Pharmaceuticals Co. Ltd. had less to do with the nine-figure damages than ending private plaintiffs’ losing streak challenging deals delaying cheaper generics.
    • “The Boston federal jury’s finding that Takeda improperly paid a competitor to delay it from bringing a generic version of its Amitiza constipation medication to market marked the first time a private plaintiff won at trial in a reverse-payment case.
    • “Most challenges to deals between branded drug companies and generic makers either settle or are dismissed before reaching trial, with the more nuanced agreements sometimes making it to a jury. Three have been tried before a jury since the US Supreme Court put drugmakers on notice that the dealings could run afoul of antitrust laws. Until Monday, juries had rejected plaintiffs’ claims each time. 
    • “I expect the case to send ripples through legal departments — if not boardrooms — across the country,” said Robin Feldman, a law professor at the University of California in San Francisco who studies pharmaceutical regulation and intellectual property. She called the verdict a “groundbreaking decision.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country. Because of the later start, some areas of the country may continue to see higher levels of RSV through May. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is low in most areas of the country. Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “As the nation moves closer to topping last year’s measles total in just the first half of 2026, the Centers for Disease Control and Prevention (CDC) today confirmed 59 new cases in a nationwide outbreak that has now reached 1,952 infections. 
    • “All but nine cases are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.”
  • and
    • “Although an Ebola outbreak is growing rapidly in central Africa, experts say it doesn’t pose a public health threat to the United States.
    • “The outbreak, centered in the Democratic Republic of the Congo (DRC), has grown to nearly 750 suspected cases and more than 170 deaths, the World Health Organization (WHO) announced today. Although the risk from Ebola in the DRC is high, the risk of global spread is low, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said. 
    • “Many US infectious diseases experts agree.
    • “This is a horrible situation in affected areas of Africa,” said Michael T. Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, which publishes CIDRAP News. “But for the world, it is not.”
    • “That’s because Ebola, which spreads through contact with bodily fluids, is far more difficult to spread than the airborne respiratory viruses that Americans have confronted in recent years, such as influenza, COVID-19, measles, and even the Andes strain of the hantavirus, which recently caused an outbreak on a cruise ship.”
  • BioPharma Dive points out,
    • “ASCO26: 5 data snapshots ahead of the year’s biggest cancer drug meeting.
    • “Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting gave a peek at anticipated datasets from Merck, BioNTech, Eli Lilly and Moderna.”
  • Per a National Institutes of Health news release,
    • “A team of researchers at the National Institutes of Health (NIH) have unveiled new details about the events GLP-1 receptor agonists trigger within neurons, which have been largely unexplored until now. A study in mice identified key intracellular signaling processes that are tied to the weight-loss effects of the GLP-1 drug semaglutide. The findings improve our understanding of how increasingly prevalent GLP-1s may influence human behavior and identify new opportunities to potentially enhance treatment.
    • “The weight-loss benefits of GLP-1s are well documented and scientists generally know the brain regions associated with these effects. However, several questions remain, such as why responses to medication differ between patients and why the effects for most eventually plateau.
    • “We know much less about the nuts and bolts of what goes on within the neurons that these medications target. By digging into these mechanisms, we’re beginning to answer some of these questions,” said co-corresponding author Andrew Lutas, Ph.D., an investigator at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).”
  • CNN reports,
    • “Pregnant women are routinely advised to take prenatal vitamins for their health and their baby’s development. Now, a new study published Monday in JAMA Network Open concluded that children whose mothers received higher-dose vitamin D supplements during pregnancy performed better on certain memory tests at age 10.”
  • MedPage Today relates,
    • “Preserved global brain structure appeared to buffer cognitive decline in people with Alzheimer’s pathology.
    • “Younger-appearing brains had weaker links between pathology and poorer outcomes in multiple cognitive domains.
    • “Other measures of brain reserve or cognitive reserve showed no clear protective cognitive effect.”
  • Health Day tells us,
    • “Middle-aged people who have migraine with an aura could be more at risk for stroke.
    • “Those who had migraine with aura had a 73% increased risk of stroke
    • “Middle-aged men who suffered any kind of migraine had a more than 3.5-fold increased risk of stroke.”
  • and
    • “Use of calcium, vitamin D, or combined supplementation has little to no effect on the prevention of fractures and falls in adults, according to a review published online May 20 in The BMJ.
    • “Olivier Massé, Pharm.D., from CIUSSS du Nord-de-l’Île-de Montréal, and colleagues conducted a systematic review and meta-analysis to examine the effect of calcium, vitamin D, or combined supplementation on fractures and falls in adults. A total of 69 trials, with 153,902 participants, were included in the review.
    • “Most trial participants were community dwelling (87 percent) and not at high fracture or fall risk (73 percent). The researchers found that little to no effect was found from use of calcium supplements (risk ratio, 0.91), vitamin D supplements (risk ratio, 1.00), or combined supplementation (risk ratio, 0.91) for the primary outcome of any fracture. There was little to no effect on other fracture and fall outcomes seen for calcium, vitamin D, or combined supplementation, based mainly on moderate-to-high certainty of evidence. After extensive exploration of heterogeneity across multiple subgroup analyses, the findings remained robust.”
  • BioPharma Dive informs us,
    • “The outlook for an experimental Parkinson’s disease drug dimmed on Thursday with the announcement that it had failed a key clinical trial.
    • “Developed through a partnership Denali Therapeutics and Biogen, the drug is designed to inhibit an enzyme tied to one of the most common genetic drivers of Parkinson’s: a gene called LRRK2. When this gene mutates, it causes the waste disposal systems in cells to malfunction, leading to the buildup of toxic proteins that damage and destroy neurons.
    • “In 2022, Biogen and Denali kicked off what would ultimately become a nearly 650-person trial that pitted their drug against a placebo. The companies are now saying this mid-stage study showed the drug — codenamed BIIB122 — was not significantly better at slowing the disease progression, as measured by a well-known scale clinicians use to assess how Parkinson’s is affecting a patient’s movement and daily life.”

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

  • Per an EBRI news release,
    • “The Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey found that the majority of insured individuals still receive health insurance through their employer.
    • “Employment-based health coverage remained the dominant source of health insurance for privately insured adults, with six in 10 receiving coverage through their own job.” * * *
    • “Coverage patterns have been largely stable, with about one-third enrolled in individual-only coverage and most others covering a spouse or partner.”
  • Fierce Pharma relates,
    • “With both Novo Nordisk’s and Eli Lilly’s oral GLP-1s establishing their footing in the U.S. obesity market, the companies’ respective Wegovy pill and orforglipron tablet Foundayo are making their mark on prescription trends for a class previously confined primarily to injectables.
    • “Looking at the past four weeks, total U.S. GLP-1 prescriptions were up 3.6%, compared to 1.8% at the same time last year, analysts at Citi wrote in a Friday note to clients, citing script tracking data from IQVIA. The Citi team attributed that momentum to the ability of Novo’s and Lilly’s new oral launches to “broaden and reshape the market” for obesity incretin drugs.”
  • MedCity News considers whether “Mark Cuban’s Cost Plus Wellness Appeal to Employers?”
    • Employer advocates said Cost Plus Wellness could help spur more direct contracting and transparency in healthcare, though they questioned whether the model can scale and adequately measure provider quality and outcomes.
  • Beckers Hospital Review reports,
    • “Philadelphia-based Penn Medicine reported an operating income of $238.5 million (2.4% margin) for the nine months ended March 31, up 46.3% from $163 million (1.9% margin) in the same period last year, according to financial documents filed May 20.
    • “The results follow the April 1, 2025, acquisition of Doylestown (Pa.) Health. Doylestown Hospital, a 245-bed teaching hospital, became Penn Medicine’s seventh hospital and is now known as Penn Medicine Doylestown Health.”
  • STAT News tells us,
    • “Retro Biosciences, the longevity startup backed by OpenAI CEO Sam Altman, has raised more money at a $1.8 billion valuation, it announced Friday. 
    • “Retro has a big mission: Add 10 healthy years to the human lifespan. It is seeking to do that by using a variety of technologies, including in vivo gene therapies, cell replacement therapies, and other approaches to spur younger, healthier cells into aging tissues.
    • “The company is currently running its first clinical trial — testing a pill designed to enhance the body’s ability to better clear out protein aggregates in patients with Alzheimer’s disease. Retro CEO Joe Betts-LaCroix told the audience at STAT’s Breakthrough Summit West on Tuesday that the trial is going “super good” and that researchers haven’t seen any dose-limiting toxicities. He said he anticipates releasing some data from the trial around August.”  
  • Fierce Healthcare informs us,
    • “Innovaccer acquired CaduceusHealth to combine its AI platform with the company’s revenue cycle management services and staff to serve ambulatory care providers.
    • ‘Innovaccer, founded in 2014, built software solutions to unify enterprise data and applies AI to automate manual tasks and streamline workflows for payers and providers. Last year, it rolled out Flow Auth, an AI-powered prior authorization solution that is part of Flow by Innovaccer, an AI-powered revenue cycle suite designed to modernize financial operations for health systems. Other capabilities include Flow Capture, an autonomous medical coding solution and Flow Collect, an AI-powered denial management and revenue recovery tool.
    • “Innovaccer claims that it now serves over 200 health systems and payers, 95% of community pharmacies and 80 million patient lives across the United States. Flow is built on Gravity, Innovaccer’s healthcare AI infrastructure platform.”
  • and
    • “Eugene, Ore.-based Ksana Health is undertaking a multi-institutional research effort aimed at creating a new class of artificial intelligence to advance mental health and substance use disorder treatment and prevention.
    • “The software company was awarded a $17.9 million contract by the U.S. Department of Health and Human Services (HHS) to create a Large Health Behavior Model (LHBM). Its goal is to train AI models on smartphones and other wearables data, including sleep, mobility and language use linked to large scale electronic health records (EHRs).
    • “This initiative augments Ksana’s current efforts to shift behavioral healthcare from episodic, subjective assessment toward continuous, data-driven health promotion, reducing healthcare spending, improving quality of life, and reaching populations that currently lack access to effective behavioral health support,” said Tony Scripa, Ksana Health COO and project co-investigator, in a statement.”
  • and
    • “More than seven in 10 Medicare members report feeling confusion or uncertainty when navigating online health information, a new whitepaper from CVS Health found. 
    • “The research (PDF) drew insights from Medicare-eligible consumers through surveys, interviews and ethnographic studies. 
    • “Seventy-one percent of respondents report an eagerness to use more digital health care tools and 86% report an eagerness to use them. However, 58% of respondents report that low digital health literacy is negatively impacting their ability to manage their health. 
    • “We’re caring for the fastest-growing and most clinically complex population in the country, and what we found in the research challenges a common assumption—older adults actually are more open to engaging with technology than many think,” said Dr. Benjamin Kornitzer, M.D., Aetna senior vice president and CMO, in a statement. “It creates a real opportunity to meet them where they are and provide day-to-day support, whether it’s managing medications, following up after a visit, or staying on track with chronic conditions. Technology and engagement can help them live healthier, more independent lives.”
    • “As a result, CVS said it is applying insights from the research across its digital offerings, including clearer navigation, stronger accessibility features and added privacy and security transparency.” 

Thursday report

David Ermer–CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

A commenter, Patrick Morselli, accurately observed in response to the OPM Director’s blog post that “Simplicity has a high cost in most organizations. Feels like the hardest work is undoing complexity other smart people left behind.”

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Republicans broke with President Trump over his administration’s plan to create a $1.8 billion settlement fund to pay people who claim political persecution, with widespread opposition forcing party leaders Thursday to abandon votes on immigration-enforcement funding and send lawmakers home early for their Memorial Day break.
    • “The “anti-weaponization” fund is a Trump priority, after he alleged for years that his supporters, including those prosecuted over the Jan. 6, 2021, attack at the Capitol, had been targeted unfairly by the Biden administration. But its creation has run into blowback in the Senate, and the immigration-enforcement bill gave senators leverage to dig in their heels.
    • “I don’t like the fund at all,” said Sen. John Curtis (R., Utah), who added he didn’t think any guardrails could fix it. Sen. Thom Tillis (R., N.C.), a frequent target of Trump criticism who is retiring, called it a “payout pot for punks.”
    • “With no resolution in sight, Senate Majority Leader John Thune (R., S.D.) sent senators home for their weeklong Memorial Day recess, putting the Republican-led Congress on course to miss Trump’s deadline to have the Immigration and Customs Enforcement and Border Patrol measure on his desk by June 1.”
  • Healthcare Dive relates,
    • “Lawmakers are mulling reform of how Medicare pays physicians, concerned that insufficient reimbursement in the federal insurance program is incentivizing consolidation and increasing healthcare costs.
    • “Physician pay has declined over the past two decades when accounting for inflation, spurring independent providers to be acquired by hospital systems rather than go it alone, provider witnesses told representatives during a House Energy and Commerce subcommittee hearing Wednesday. And representatives agreed that’s a concern.
    • “Making sure that independent physician practices stay open […] is one of the most critical ways we can ensure competition and drive down costs,” said Rep. Kim Schrier, D-Wash.”
  • The American Hospital Association adds,
    • “Rep. Randy Feenstra, R-Iowa, introduced the Rural Maternity Options for Medical Support Act on May 19. The bill would guarantee that beds used solely for labor and delivery are not counted toward the 25-bed limit for critical access hospitals. The bill is co-sponsored by Reps. Darin LaHood, R-Ill., Jill Tokuda, D-Hawaii, and Kim Schrier, D-Wash. 
    • “New and expecting moms deserve access to high-quality labor and delivery services,” said Lisa Kidder Hrobsky, AHA senior vice president for advocacy and political affairs. “The Rural Maternity Options for Medical Support Act of 2026 strengthens access to maternal health services for mothers in rural areas by ensuring that higher volume critical access hospitals have labor and delivery beds available, even if their other patient beds are full. The AHA appreciates Rep. Feenstra’s leadership to support critical access hospitals and families across the nation.” 
  • and
    • “The House Education and Workforce Committee May 21 unanimously passed the Transparency in Billing Act (H.R. 8684). The bill would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and it would impose civil monetary penalties on hospitals that violate the requirement. 
    • The AHA has previously opposed this policy, saying that hospitals are already transparent about the location of care delivery on their bills and that it would create a significant administrative burden to providers and the health care industry at large.” 
  • Fierce Healthcare tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. removed two key leaders of the U.S. Preventive Services Task Force (USPSTF), a key advisory panel that offers guidance on preventive services, according to media reports.
    • ‘Vice chairs John Wong, M.D. and Esa Davis, M.D. were dismissed from the task force in letters sent to them by Kennedy on May 11, The New York Times reported on Wednesday, citing copies of the letters obtained by reporters. STAT, CNN, Politico and The Hill also reported the terminations, citing the letters.” * * *
    • “The terminations leave the panel with just eight sitting members. Five other members saw their terms expire at the start of this year, and Kennedy did not replace them, and the previous chair, Michael Silverstein, departed on his own, STAT reported.”
  • Federal Network News informs us,
    • “Shane Stevens, the top official for the Office of Personnel Management’s healthcare and insurance arm, is stepping down from his role, Federal News Network has learned.
    • “Stevens, a political appointee, has been serving as associate director of healthcare and insurance at OPM since last summer. He announced in an email Thursday afternoon that he is voluntarily resigning, effective immediately.”
  • Best wishes, Mr. Stevens. Thanks for your service.
  • Tammy Flanagan, writing in Govexec, lets us know “what federal employees get wrong about divorce and retirement.”
    • “Errors involving survivor benefits, health coverage and court orders can create financial problems years after a marriage ends.”
  • FedWeek explains “Insuring Children at College and Federal Benefits Considerations (with a Checklist).”

From the Food and Drug Administration front,

  • Radiology Business reports,
    • “Medtronic is recalling more than 18,000 surgical devices due to a risk of contamination. The recall includes certain lots of the company’s Gundry and DLP retrograde cannulae, which are cardiopulmonary bypass vascular catheters used to perform open heart surgeries.
    • “This recall was put in place due to the potential of a sterile barrier breach. Only certain lots of these devices are included in the recall.
    • ‘The U.S. Food and Drug Administration (FDA) has ruled this as a Class II recall. This means the agency believes these devices could cause “temporary or medically reversible adverse health consequences.”
  • STAT News relates,
    • “Wearable maker Whoop has not resolved a dispute with the Food and Drug Administration over a blood pressure feature the company launched last year, according to a top health executive at the company. 
    • “FDA warned Whoop last July over the feature that gives users a daily estimate of their systolic and diastolic blood pressure, saying that it’s a medical device that requires agency review. Whoop argues that the feature is exempt from FDA review because it is intended for wellness purposes.” * * *
    • “The dispute between FDA and Whoop turned up the heat in a simmering debate about how the agency ought to oversee low-risk products. Proponents of deregulation argue that the time and expense required for FDA authorization impede innovation and that FDA review is unnecessary to ensure the safety of many products that potentially benefit consumers.”

From the judicial front,

  • Federal News Network reports,
    • “Some federal employees may now have an easier time qualifying for disability retirement benefits, following a recent precedential decision from the U.S. Court of Appeals for the Federal Circuit.”
    • “In April, the court ruled that federal employees’ disability retirement applications cannot be denied solely based on a lack of “objective” medical evidence. The ruling applies in cases where federal employees have already been removed from their jobs due to a “medical inability to perform.”
    • “Objective documentation, like lab tests or prescription lists, can support an argument but cannot be the sole basis for denying claims, the court said. “Subjective” medical evidence, like a diagnosis based on self-described symptoms, must also be considered. If employees’ disability retirement claims rely on subjective evidence, they won’t automatically be denied benefits.
    • “The decision last month overturned a 2024 ruling from the Merit Systems Protection Board, which had upheld the Office of Personnel Management’s denial of a disability retirement application from a former OPM employee in 2016.”
  • The New York Times relates,
    • “The Justice Department announced charges on Thursday against 15 people for attempting to defraud Minnesota Medicaid and other social service programs in the state of more than $90 million. 
    • “Top officials, including Robert F. Kennedy Jr., the health and human services secretary, and Mehmet Oz, head of the Centers for Medicare and Medicaid Services, appeared in Minneapolis to announce the charges. “The fraud here in Minnesota is shocking,” said Colin McDonald, an assistant attorney general overseeing the administration’s crackdown on fraud.
    • “Among the defendants are an owner and an employee of autism clinics, who are charged with submitting $46.6 million in fraudulent claims to Medicaid, the public health plan that covers low-income people. Additional defendants were charged with filing bogus claims to Medicaid for other services, including those that assist disabled people with obtaining housing and living independently.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The world’s most popular weight-loss and diabetes drugs are linked to a powerful new possible benefit: better outcomes for cancer patients. 
    • “A suite of four new studies suggest that people taking so-called GLP-1 drugs like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro saw reductions in tumor progression, lower overall chance of death and less risk of developing breast cancer.
    • “It’s really provocative that they showed, in several cancers, that people who took these drugs seem to have a lower risk of their cancer returning,” said Dr. Jennifer Ligibel, a breast oncologist at the Dana-Farber Cancer Institute who wasn’t involved in any of the studies.
    • “One study from researchers at the Cleveland Clinic Cancer Institute tracked more than 10,000 patients with early-stage cancers who started GLP-1 drugs after diagnosis and compared their disease progression to those on a different diabetes medication. Those on GLP-1s were less likely to see their cancer spread.
    • “In lung cancer patients, the rate of progression to advanced disease was cut roughly in half—10% in GLP-1 users versus 22% in the comparison group. Breast cancer patients showed a similar pattern, with progression rates of 10% versus 20%. Colorectal and liver cancers also showed statistically significant reductions.”
  • and
    • “An investigational drug developed by Eli Lilly LLY  delivered clinically meaningful weight loss in a trial, the company said as it looks to expand its obesity treatment portfolio amid soaring demand.
    • “Lilly said Thursday that retatrutide, designed to be taken once a week, met the primary endpoint in a phase 3 clinical trial, as well as key secondary endpoints.
    • “According to Ania Jastreboff, a Yale School of Medicine professor and lead investigator for the trial, every dose of retatrutide assessed resulted in clinically meaningful weight reduction for nearly all participants. On average, those with severe obesity on the highest dose lost 30% of their body weight over two years, Jastreboff added.
    • “The trial evaluated the therapy’s efficacy and safety on adults who are overweight and had other medical conditions such as type 2 diabetes, chronic pain and cardiovascular issues.
    • “More results will be shared later this year, Lilly added.”
  • Healio adds,
    • “Studies show that GLP-1 receptor agonists have significant potential for treating glaucoma, diabetic retinopathy and other eye diseases, but important nuances remain to be investigated, according to a review published in BMC Ophthalmology.
    • “Although GLP-1 RAs have revolutionized metabolic disease management, their potential therapeutic role in ocular diseases — particularly those driven by shared metabolic and inflammatory pathways — remains underexplored,” Yu Luo, of Beijing University of Chinese Medicine, and colleagues wrote. “Their multifaceted neuroprotective properties and anti-inflammatory mechanisms present a distinctive therapeutic opportunity for ophthalmic pathologies, potentially offering direct ocular benefits beyond systemic metabolic control.”
  • and
    • “Adults with obesity achieved greater long-term weight loss if they partook in a nutrition plan designed for rapid weight loss compared with one designed for gradual weight loss, according to trial data.
    • “Line Kristin Johnson, RD, PhD, senior researcher at Vestfold Hospital Trust in Norway, said there has been debate among researchers regarding whether rapid weight loss leads to worse long-term outcomes for people with obesity. In findings from a randomized pragmatic trial presented at the European Congress on Obesity, Johnson and colleagues found implementing a calorie-restricted eating pattern for rapid weight loss can induce a larger decrease in body weight at 1 year than a gradual weight-loss eating pattern.”
  • Endocrinology Advisor points out,
    • “Life-course body size progression, particularly transitioning from a thinner childhood body size to adult obesity, significantly increases risks for stroke, coronary artery disease, and heart failure.”
  • Healio also notes,
    • “Only a third of cancer survivors receive advice on weight control and improving their diet from health care professionals, and less than half are informed about the benefits of physical activity.
    • “Individuals who do receive advice on losing weight, salt and fat intake, and exercise are three to eight times more likely to engage in healthy behaviors than those who did not.
    • “We need more effort to deliver lifestyle behaviors to patients,” Chao Cao, PhD, MPH, instructor in the department of medical oncology at Dana-Farber Cancer Institute, told Healio.”
  • Fierce Pharma tells us,
    • “Phase 3 data for Merck & Co. and Kelun-Biotech’s antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) suggest the race is heating up to establish a new standard of care in first-line non-small cell lung cancer.
    • “According to an abstract released ahead of the ASCO 2026 annual meeting, combining the TROP2-directed ADC with Keytruda slashed the risk of disease progression or death by a major 65% compared with Keytruda alone in treatment-naïve, PD-L1-positive NSCLC. The p-value is below 0.0001, suggesting high statistical significance.
    • “Key overall survival results, which will underpin regulatory considerations in first-line NSCLC, were not mature at the Sept. 29, 2025, data cutoff, but a strong trend with a preliminary 45% improvement in favor of the combo arm was observed.” 
  • Per MedPage Today,
    • “Undetected attention deficit-hyperactivity disorder (ADHD) was not uncommon among adults hospitalized after traffic accidents, according to a cross-sectional study from the Dominican Republic.
    • ‘Among 95 adults admitted for traffic-related injuries without a prior diagnosis, more than a third (34.7%) screened positive on the Adult ADHD Self-Report Scale, reported Amanda Abreu, MD, of the Universidad Iberoamericana in Santo Domingo, Dominican Republic.
    • “High-risk driving behaviors — including violations, mistakes, and slips — were more common among adults who screened positive (66.6% vs 30.6%, P=0.0016), she reported at the American Psychiatric Association annual meeting.
    • “We’re not saying that ADHD alone caused the accidents, nor are they unsafe drivers, but these findings suggest that this is a really vulnerable population we should look into, and we should help protect,” Abreu said.”
  • and
    • “Low-risk pancreatic cystic lesions were found to be associated with a long-term risk of pancreatic cancer in a retrospective cohort study.
    • “The incidence rate of pancreatic cancer among patients with pancreatic cystic lesions was higher than that of the general population (1.89 vs 0.14 per 1,000 person-years).
    • ‘Over a quarter of patients were diagnosed with pancreatic cancer more than 5 years after detection of lesions, suggesting longer-term follow-up is needed to avoid missed diagnoses.”
  • Per the Wall Street Journal,
    • “New French research links natural food color additives to increased risks of Type 2 diabetes and cancer, similar to synthetic dyes.
    • “Beta-carotene, curcumin and anthocyanins used as color additives were linked to a higher risk of Type 2 diabetes. Beta-carotene used as a food coloring was also linked to breast cancer.
    • “The findings challenge the Trump administration’s push for natural dyes and food companies’ shift away from artificial colors.”
  • Per BioPharma Dive,
    • “BioMarin is looking to expand the use of its top-selling medicine, Voxzogo, with positive study results released Wednesday.
    • I’n 2021, Voxzogo became the first drug approved to improve growth in children with achondroplasia, the most common form of dwarfism. The new results pertain to a related condition called hypochondroplasia that generally presents in less severe ways and might not be noticed until later in a child’s life.
    • ‘In the Phase 3 trial, researchers found participants given Voxzogo were growing faster than those who received a placebo. After a year, the Voxzogo patients also had significant increases in standing height and arm span, a key finding that could help children function better in daily tasks and retain more independence.”

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

  • Managed Healthcare Executive reports,
    • ‘For the average person, healthcare costs rose 7.9% in 2026 to $8,460, which is the highest annual increase in more than a decade, according to the 2026 Milliman Medical Index
      (MMI). For a hypothetical family of four, healthcare costs reached $37,824, Milliman found. The Milliman Medical Index measures healthcare costs covered by a typical employer-sponsored health insurance plan.”
    • “The increase reflects structural forces that are not going away, Milliman Principal and Consulting Actuary Deana Bell said in a news release. “Outpatient costs have quadrupled for the MMI’s family of four since the MMI was first published in 2005, with much of the trend exacerbated by delivery system consolidation, specialty drug growth, and site-of-care shifts.”
  • Beckers Hospital Review relates,
    • “The National Council of State Boards of Nursing found the District of Columbia has the most licensed nurses per capita, while Utah is the state with the fewest for the second year in a row.
    • “The organization created a course of nursing licensure statistics in the U.S. and its territories. The data was compiled using the NCSBN’s database and Nursys, an electronic information system where regulatory bodies enter licensure data. All of the council’s 58 members shared licensure data, which amounted to 6,903,665 registered and practical nurses — up from 6,870,362 last year.
    • ‘According to the data, Wyoming and Vermont had the fewest licensed nurses in their states overall, at 9,620 and 13,528, respectively. Meanwhile, California and New York had the most licensed nurses at 708,141 and 610,207, respectively.” 
  • Healthcare Dive tells us,
    • “Nonprofit health system Providence is throwing in the towel on the majority of its health insurance businesses, citing the difficulty of running a regional health plan amid regulatory pressures and rising costs.
    • “Starting next year, Providence, which covers about 440,000 people in a handful of western states, will no longer offer Medicaid, Affordable Care Act or employer-sponsored plans, the Renton, Washington-based system announced on Wednesday.
    • ‘The decision comes as Providence attempts to shore up its financial footing and refocus on delivering care. Still, the company plans to maintain its Medicare Advantage operations through a partnership with a national carrier, according to the release.”
  • Modern Healthcare tells us,
    • “Sutter Health and Allina Health have moved a step closer to joining forces.
    • “Sacramento, California-based Sutter and Minneapolis-based Allina said Thursday they signed a definitive agreement to form a $26 billion combined system with 39 hospitals. The agreement follows a letter of intent announced in March. The proposal is on track to close by the end of the year pending customary regulatory approval, the organizations said in a news release.” 
  • BioPharma Dive informs us,
    • “Eli Lilly has snagged Engage Biologics, a biotechnology company that aims to deliver genetic medicines without viral payloads, in a deal worth up to $202 million.
    • “Lilly said Wednesday it has acquired the preclinical biotech in an all-cash deal, including an undisclosed upfront payment, with the possibility of future payouts based on research, development and commercialization milestones. The acquisition gives Lilly non-viral DNA delivery technology, dubbed the “Tethosome” platform.
    • “We believe that the combination of Engage’s platform with Lilly’s significant capabilities will meaningfully accelerate development of new genetic therapies,” Will Olsen, co-founder and CEO of Engage, said in a statement.”
  • Fierce Healthcare lets us know,
    • “Electronic medical record (EMR) company Canvas Medical launched Canvas Studio Thursday, a no-code interface that allows clinicians and other healthcare professionals to build custom EMR workflows.
    • “Canvas Medical CEO Adam Farren told Fierce Healthcare the company was “serving a market” for software developers to customize workflows for end users within its ONC-certified EHR platform. 
    • “What Studio does is replace the developer with an AI agent, so that the end user, the clinician or administrative staff user, can directly customize and extend Canvas themselves using the agent,” Farren said.”
  • and
    • “Employers are set to significantly increase their use of AI in health benefits, a new survey shows, even as they continue to face barriers to rolling out the tech.
    • “WTW polled 312 employers with about 4.6 million workers for the 2026 AI Use in Health and Benefits Survey, and found that 72% of those surveyed plan to embed AI into their benefits programs in the next two years. By comparison, only 20% said they are currently doing so.
    • “The employers cited several key areas where they see AI likely supporting benefits at work, such as improved communication, cited by 68%, and data insights and analytics, noted by 59%. In addition, 57% of those surveyed said AI would likely support greater personalization.
    • “Jeff Chandler, North America commercialization leader for Health & Benefits at WTW, said in a press release that these top priorities are all “areas where AI can materially improve how benefits teams make decisions and support employees.”

Friday report

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

From Washington, DC

  • Roll Call informs us,
    • “Republican leaders in Congress scored some victories this week in nominations and appropriations but struck out on easily advancing their partisan “reconciliation 2.0” proposal to fund immigration enforcement.
    • “The bill faces a hurdle in the form of the Senate Parliamentarian, who on Thursday evening advised that several provisions violate the Senate’s restrictive Byrd rule — and more could be coming. 
    • “This throws an obstacle in the way of the GOP’s efforts to provide some $72 billion in funding for immigration enforcement by President Donald Trump’s June 1 deadline, as Republicans will have to rewrite parts of the package to pass it with the filibuster-proof budget reconciliation process, requiring a simple-majority vote to pass, instead of the 60-vote threshold required for regular legislation.
    • “Republicans are expected to try to rewrite the legislation to remedy the violations or, if that’s not possible, remove the offending provisions ahead of a Homeland Security Committee markup of the title next week. 
    • “Senate Parliamentarian Elizabeth MacDonough was expected to hold a second “Byrd bath” Friday to hear arguments from Democratic and Republican Senate staff about the Judiciary Committee’s portion of the bill, including Secret Service money for security upgrades tied to Trump’s White House ballroom project.” 
  • Mercer Consulting reports,
    • “With the midterm congressional elections approaching and healthcare affordability top of mind for voters, lawmakers are actively considering new healthcare transparency reforms, including requirements for providers to show plainly what patients will have to pay and new billing standards for hospitals.
    • “Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy, R-LA, highlighted such price transparency legislation — Patients Deserve Price Tags Act (S 2355/HR 5582) — during a field hearing in Louisiana during last week’s congressional recess. Cassidy’s interest could signal that the legislation, which has may cosponsors from both parties, could soon see action at the Committee. 
    • “The bill would codify and expand current hospital price transparency rules that were established in the first Trump administration by extending requirements to clinical diagnostic laboratories, imaging centers, and ambulatory surgical centers. It would also make the prices that hospitals post clearer by requiring actual dollar-and-cents amounts, not estimates, as well as sharply increase financial penalties for hospitals and insurers that fail to disclose their negotiated rates. In addition, group health plans and insurers would have to give patients upfront, personalized cost estimates through an online self-service tool, as well as paper or phone options, before care is provided. The bill also ensures group health plans have access to claims data and prohibits third-party administrators from restricting that access.
    • “While several plan sponsor trade groups publicly support the legislation, they are working with lawmakers to make certain provisions more workable and better aligned with the PBM-focused transparency rules enacted in the Consolidated Appropriations Act, 2026 and proposed by the Department of Labor.”
  • AHIP lets us know “What They Are Saying: Broad Range of Experts Agree on a Root Cause of Healthcare Cost Crisis.”
    • “The evidence continues to underscore that making healthcare more affordable requires policymakers to address the root causes of high costs head-on through common-sense solutions like cracking down on anti-competitive hospital mergers and implementing site-neutral payment reforms.
    • “To learn more about how rising hospital costs are driving premiums higher and what policymakers can do to address it, visit AHIP.org/CostConnection.”
  • Fierce Healthcare relates,
    • “A bipartisan group of lawmakers in both chambers of Congress has reintroduced a bill aimed at barring companies from owning both a pharmacy benefit manager and retail pharmacies.
    • “The bill, called the Patients Before Monopolies (PBM) Act, would force conglomerates that include a PBM to divest pharmacies that they own. The legislation has existed in some form since 2024, and since its first introduction, Arkansas has implemented a similar legislation at the state level.
    • “Last month, Tennessee legislators also passed a bill that would prevent PBMs from owning pharmacies, which the governor is expected to sign into law.”
  • Mercer adds,
    • “Several developments in 2026 signal that the Trump administration is committed to improving behavioral health benefits for group health plan participants and beneficiaries — but the administration intends to put its own stamp on enforcement of the Mental Health Parity and Addiction Equity Act and propose new rules interpreting the landmark law.”
  • Per an HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $255 million to Vibrant Emotional Health (Vibrant) to administer the 988 Suicide & Crisis Lifeline. The 988 Lifeline is a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded network administrator. The 988 Lifeline has received more than 25 million contacts via call, text, chat, and ASL videophone since its launch.”
  • Modern Healthcare notes,
    • “The Centers for Medicare and Medicaid Service solicited the healthcare industry on ways it can identify and prevent fraud.
    • “The anti-fraud push drew cautious support, with providers and insurers seeking clear guardrails.
    • “Providers and insurers urged CMS to target high-risk services and avoid sweeping actions that would hamper care.” * * *
    • “New policies should focus on high-risk activities and not burden the ”vast majority of healthcare providers that are honorable in pursuing a mission to provide high-quality healthcare,” wrote the American Health Care Association/National Center for Assisted Living, which represents long-term care providers.
    • “The agency should also be careful not to add administrative burden since hospitals “already operate under extensive oversight requirements,” the American Hospital Association wrote.”
  • Beckers Payer Issues explains the federal crackdown on healthcare fraud, waste and abuse.
  • Newfront brings us up to date on the 2026 PCORI fee, which applies to FEHB and PSHB plan carriers.
    • “IRS Notice 2025-61 adjusts the Patient-Centered Outcomes Research Institute (PCORI) fee to $3.84 per covered individual for health plan years ending on or after October 1, 2025 and before October 1, 2026, including 2025 calendar plan years. This represents a 37-cent increase from last year’s $3.47 PCORI fee.
    • “Action Item: The annual PCORI fee must be reported and paid to the IRS by July 31, 2026, via the second quarter Form 720 (Rev. June 2026).”
  • HR Dive points out,
    • “The U.S. Equal Employment Opportunity Commission plans to end employee demographic data reporting, according to a proposal sent to the White House on Thursday.
    • “The agency wants to get rid of EEO-1, EEO-2, EEO-3, EEO-4 and EEO-5 reporting requirements. EEOC also wants to axe reporting requirements related to Title VII of the Civil Rights Act, the Americans with Disabilities Act, the Genetic Information Nondiscrimination Act and the Pregnant Workers Fairness Act.
    • “EEO-1 reporting has been a cornerstone of HR duties, required by firms with 100 or more employees and federal contractors with 50 or more employees that meet certain requirements. EEOC and analysts have used it to assess demographic data nationally, and — while the process is sometimes viewed as burdensome — employers have reportedly used the collected data for self-assessments regarding nondiscrimination and diversity.”
  • The Census Bureau notes,
    • “Since 2020, city centers of many major U.S. metro areas have had sluggish population gains, with some places even declining. But where growth did occur, it was mostly on the outer edges of these metro areas — with some exceptions.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With the ink barely dry on outgoing commissioner Marty Makary’s resignation, another top regulator may be heading for the exit at the FDA. 
    • “Tracy Beth Høeg, M.D., Ph.D.—who was named acting director of the agency’s Center for Drug Evaluation and Research (CDER) following the departure of veteran oncologist Richard Pazdur, M.D., last December—is now expected to depart in Makary’s footsteps, Reuters reported Friday, citing three sources familiar with internal plans at the regulator.” * * *
    • “Reuters clarified in its report that the CDER chief’s departure is likely, but that the decision has not yet been finalized.” 
  • and
    • “With the help of DNA testing company Natera and its personalized molecular residual disease (MRD) blood test Signatera, Roche’s PD-L1 inhibitor Tecentriq has chalked up its eleventh U.S. indication in the form of a new bladder cancer approval.
    • “Tecentriq and subcutaneous Tecentriq Hybreza can now be used as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) following a cystectomy, as identified by Signatera.” 
       
  • Biopharma Dive relates,
    • “The Food and Drug Administration has placed a clinical hold on Aardvark Therapeutics’ drug for Prader-Willi Syndrome, escalating a trial stoppage that began when signs of potential heart problems were detected in a study of healthy volunteers. 
    • “Aardvark said Thursday it will “unblind,” or reveal which enrollees in a late-stage trial received ARD-101, in order to help investigators and regulators determine whether the drug is safe and effective enough to continue testing in humans.
    • “The company has dosed 68 people in the placebo-controlled Phase 3 trial and another 19 in an open-label extension study, both which were intended to measure whether ARD-101 can address the “hyperphagia,” or insatiable hunger, distinctive to Prader-Willi. The cardiovascular concerns emerged from a safety trial in healthy people who’d received much higher doses than what was administered in the other studies.” 
  • Cardiovascular Business tells us,
    • “Stryker Sustainability Solutions, an Arizona-based division of Stryker focused on reprocessing single-use medical devices, has recalled certain lots of several reprocessed electrophysiology (EP) catheters. The recall, which covers more than 8,000 devices overall, was initiated after the company identified incomplete seals due to a process control issue.
    • “According to the U.S. Food and Drug Administration (FDA), this is a Class II recall. This means the agency believes the devices “may cause temporary or medically reversible adverse health consequences.”
  • The Wall Street Journal points out,
    • “Twenty people in Japan who took Amgen’s rare-disease drug Tavneos have died, and at least 22 developed a potentially fatal liver injury, according to Kissei Pharmaceutical, which sells the medicine in the country.
    • “Kissei told doctors Friday to stop prescribing the drug to new patients.
    • “The Japanese drugmaker said the 20 deaths occurred in people who had suffered a serious liver “impairment” and attributed 13 of the deaths to a condition, called vanishing bile duct syndrome, marked by the destruction of the ducts that carry bile out of the liver.
    • “Kissei said causal links to Tavneos hadn’t been confirmed in all 20 deaths.” * * *
    • “The medicine went on sale in Japan in 2022, according to Kissei. Also that year, Amgen bought the drug’s developer, ChemoCentryx, for $3.7 billion.
    • “In January, the FDA asked Amgen to voluntarily pull the drug from the U.S. market, but Thousand Oaks, Calif.-based Amgen refused.
    • “Then in March, the FDA said it had identified 76 global cases of serious liver injury linked to Tavneos, including eight deaths. Most were reported in Japan. Of the 76 global cases the FDA identified, seven involved the syndrome, and three of those patients died.
    • “In late April, the FDA moved to formally begin withdrawal proceedings.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of May 15, 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 is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 51 new measles cases in a nationwide outbreak that has now reached 1,893 infections. All but nine cases are locally acquired, with the rest related to international travel.
    • “The agency reported two new outbreaks, for a total of 27. Last year the nation saw 48 outbreaks and 2,288 cases for the entire year. The United States could top that total in the coming months.
    • “Of this year’s cases, 21% involve children younger than 5 years, and 76% involve kids and young adults up to 19 years. Among all 2026 patients, 92% have been unvaccinated or have an unknown vaccine status. Six percent of patients this year have been hospitalized, compared with 11% last year.”
  • The American Hospital Association News relates,
    • “A Centers for Disease Control and Prevention report released May 14 found that U.S.-reported dengue cases in 2024 increased 359% above the annual average from 2010-2023. Dengue is a mosquito-borne viral disease that can cause mild to severe illness and death. There were 3,798 cases reported to the CDC in 2024, compared to the average of 828 from 2010-2023. The report found that 97.2% of cases in 2024 were travel-associated and that 2.8% were acquired locally. Individuals age 50-59 accounted for 21.8% of cases, and 57.5% of cases occurred in Hispanic or Latino individuals. In addition, 36.1% of patients were hospitalized and a total of six patients died. Most travel-linked cases were acquired in the Caribbean (34.1%), North America (24.3%) and Central America (15.6%).” 
  • Health Day informs us,
    • People who have survived a heart attack appear to have a higher risk of brain decline into dementia, a new study says.
    • On average, heart attack survivors have a yearly 5% increased risk of developing cognitive impairment, researchers reported today in the journal Stroke.
    • “Having had a heart attack in the past may speed up the decline in memory and thinking over time,” said lead researcher Dr. Mohamed Ridha, an assistant professor of neurology at Ohio State University in Columbus.
    • “Given the rising burden of dementia and cognitive decline among Americans, it is important to understand how cardiovascular disease affects their brain health,” Ridha said in a news release. “This knowledge can help heart attack survivors take steps to improve their brain health as they age.”
  • and
    • “Offering sigmoidoscopy screening reduces colorectal cancer (CRC) incidence in men and women — with a greater reduction among men — and reduces CRC mortality in men, according to a study published online May 12 in the Annals of Internal Medicine.
    • “Edoardo Botteri, Ph.D., from the Norwegian Institute of Public Health in Oslo, and colleagues report on the benefits of sigmoidoscopy after 23 years in a randomized controlled trial involving persons aged 50 to 64 years. A total of 100,210 persons were randomly assigned to screening with once-only sigmoidoscopy with or without one fecal immunochemical test or to no screening. The intention-to-screen analyses included 98,654 persons: 20,552 in the screening group and 78,102 in the no-screening group.
    • “The researchers found that the 23-year cumulative risk for CRC was 4.3 and 6.0 percent in the screening and no-screening groups, respectively, among men. The corresponding risks were 4.2 and 4.7 percent among women. In men, the 23-year cumulative risk for CRC death was 1.4 and 2.2 percent in the screening and no-screening groups, respectively, while in women, the corresponding risks were 1.3 and 1.4 percent. The strongest effect was seen for rectosigmoid cancer. Screening benefits were not changed with the addition of fecal blood testing.”
  • Healio adds,
    • “The survival benefit conferred by lung cancer screening in real-world settings may be smaller than observed in the pivotal trial on which national screening guidelines are based, study results suggest.
    • “Veterans receiving primary care in the VA health system exhibited a threefold higher risk for all-cause mortality than participants in the randomized National Lung Screening Trial (NLST) who had similar age and tobacco history.
    • “This is one of the first times we have been able to directly compare people who were enrolled in the trial with people in a real-world cohort who are eligible for screening,” Alison S. Rustagi, MD, PhD, assistant professor in University of California San Francisco’s department of medicine, told Healio. “It is not often that we see hazard ratios on the order of 3 in observational analyses. This shows a profound difference between these two populations.”
  • Per Medscape.
    • “Orforglipron, an oral GLP-1 receptor agonist, helps maintain weight loss after injectable therapies like tirzepatide and semaglutide, offering a practical continuation option for patients. Cardiometabolic benefits are largely preserved despite some weight regain.”
  • Per an National Institutes of Health news release,
    • “A group of pediatric eye disease researchers supported by the National Institutes of Health (NIH) has launched an open-access tool designed to help manage pediatric cases of amblyopia, a condition in which the brain fails to properly develop normal vision in one or both eyes early in life. It is the leading cause of preventable single-eye (monocular) vision loss, affecting three of every 100 children in the nation. The tool is aimed at expanding access to evidence-based amblyopia clinical-decision-making expertise amidst a shortage of pediatric eye care specialists in the United States.
    • “This online tool quickly distills the relevant literature into individualized treatment advice for busy clinicians anywhere with internet access. Those without internet access can utilize the article figures as clinical reference sheets,” said article lead author, Allison Summers, O.D., associate professor, Oregon Health & Science University, Portland.” * * *
    • “Known as the Amblyopia Navigator Decision-Support Instrument (ANDI), the tool is designed to guide any eye doctor through the diagnosis of amblyopia. Once amblyopia is diagnosed, ANDI helps to guide the eye care clinician without specialty training in pediatric eye care through management options. The tool helps the eye doctor determine the best glasses prescription for the patient based on a few clinical findings. The tool also helps the doctor determine how long to monitor whether glasses alone are improving vision, which can work for up to a third of children without any further treatment.
    • “If glasses are not enough, ANDI walks the eye doctor through next steps: patching the stronger eye for a couple of hours a day, using atropine eye drops to temporarily blur the stronger eye, or considering newer digital treatments delivered through specially designed games or videos. If a child stops making progress, the tool advises whether to increase the intensity of treatment, switch approaches, reassess the glasses prescription, or refer to a specialist. It provides steps for follow-up visits and what signs of recurrence to watch for after treatment ends. The tool can be used at an initial visit, or any follow-up visit in their amblyopia care journey.
    • “ANDI was developed by PEDIG, an NIH-funded research network with over 400 investigators, and it draws on evidence from 147 published studies. To access ANDI, go to https://public.jaeb.org/pedig.”

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

  • Mercer consulting offers “bold strategies” for payers to better control high cost members.
    • “While stop-loss coverage can help mitigate risk, many employers are finding it’s no longer enough. Unsurprisingly, “more focused management of high-cost claimants” is the top priority of large US health plan sponsors in their strategic planning for the next few years. In this post, we’ll discuss four areas where focused efforts can help employers rein in costs.”
      • Understand your data: Analyzing claims to gain clarity. 
      • Strategic oversight of medical specialty pharmacy and gene/cell therapies. 
      • Take a peekaboo view into neonatal intensive care unit management. 
      • Outlier inpatient stays.
  • Fierce Healthcare reports,
    • “CVS’ Omnicare unit has secured court approval to sell its business to virtual care company GenieRx Holdings, the healthcare giant announced Thursday.
    • “GenieRx, which offers an array of virtual health and medication services, is a joint partnership between Milrose Capital, a private equity firm, and Integro Asset Management, a healthcare-focused investment firm. Per court documents, the deal includes $250 million in cash as well as certain other liabilities, such as payroll expenses.
    • “In the announcement, CVS said that in combining with GenieRx, Omnicare will “have the opportunity to strengthen its service.” It will also continue to support it current clients in the lead up to closure, which is expected later this year, pending needed regulatory approvals.”
  • Beckers Hospital Review discusses “three barriers to GLP-1 adherence — and how systems are overcoming them.
    • Patients discontinue therapy early
    • Care models incompatible with sustained support
    • Costs and side effects deter patients.
  • Fierce Pharma tells us,
    • Total prescriptions for Eli Lilly’s Foundayo reached 10,248 for the week that ended May 8, up from 7,335 the prior week, according to IQVIA data cited by Citi. While still on the rise, Foundayo’s growth pace continued to lag behind that of Novo Nordisk’s Wegovy pill during the same stage of their launch. 
    • Wegovy’s total scripts rose by 1.3% week over week to nearly 446,000, as its share in the obesity GLP-1 market climbed 0.1 percentage point to 40.5%, according to Citi.
    • However, Wegovy’s growth apparently didn’t come from its oral formulation. Wegovy pill scripts landed at about 137,000 for the week, down from roughly 143,000 the prior week, marking the first time that the pill’s scripts have fallen since the oral launch in early January.
    • Scripts from the Wegovy pill made up 31% of total Wegovy scripts for the period, down 2 percentage points from the previous week. Still, Citi analysts argued that this roughly one-third of share “suggests preferences for oral formulations.”
    • Even as Wegovy gained ground, Lilly’s Zepbound remained the obesity market leader, with 59.5% share, as its nearly 656,000 scripts marked 0.8% growth week over week. 
  • Beckers Payer Issues offers payer perspectives on artificial intelligence tools.
    • “Using AI solutions to augment the work done by humans is an attractive solution for many payers.
    • “Getting started with these technologies, however, can feel daunting.
    • “To learn more about what it takes for payers to successfully incorporate AI and support more members, Becker’s Healthcare recently spoke with Chris Caramanico, CEO of Elligint Health, Amy Qureshi, RN, executive vice president of product strategy at Elligint Health, and Steven Tolle, chairman of the board at Elligint Health. Mr Tolle has significant experience developing and implementing AI from his time at IBM, Merge and IgniteData and addition serves as Chief of AI Strategy at Elligint Health.”
  • Fierce Healthcare adds,
    • Nearly 80% of payers now prefer implementing vendor-built artificial intelligence tools rather than developing internal capabilities, a new survey from Innovaccer found.
    • The survey draws insights from 63 health insurer organization leaders, including regional health plans to national carriers, the healthcare technology and AI company said in a press release. Respondents were polled in mid-December 2025 to mid-January, and include senior and C-suite executives.
    • Innovaccer CEO and co-founder Abhinav Shashank told Fierce Healthcare that the shift to outsourced solutions reflects the focus of how to “truly operationalize AI.” 
    • “What we are seeing is an emergence of how do you have platforms that companies can effectively offer that allow for more agentic orchestration,” Shashank said. “Because the reality of it is the technology is going to be a massive addition to how payers operate.” 
  • NBC News relates,
    • “Over the past two years, medical providers across America have quietly embraced a new AI tool called OpenEvidence to help them make clinical decisions, brush up on medical knowledge and even prepare for their licensing exams. The service, a sort of chatbot for doctors, was used by about 65% of U.S. doctors across almost 27 million clinical encounters in April alone, the company told NBC News.
    • “Everyone is using it,” said Dr. Anupam Jena, an internal medicine physician at Massachusetts General Hospital in Boston and a professor of healthcare policy at Harvard. “Its growth really has been exponential.”
    • “NBC News spoke with over two dozen doctors, hospital administrators, medical students and healthcare researchers from Hawaii to Maine to explore the rise of OpenEvidence. Each individual said they either used it regularly themselves or knew someone who did.
    • “Almost two-thirds of physicians — or roughly 650,000 doctors — in the U.S. actively use OpenEvidence, while another 1.2 million use it internationally, OpenEvidence representatives said. With its quick and tailored replies, OpenEvidence has become an AI-era equivalent of consulting a colleague for their expert opinion, though the software can also write patient discharge notes and provide custom study tools for doctors’ medical exams.”