Friday report

Uncategorized

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.”

Monday report

David Ermer–CDC, CMS, Electronic health records, FDA, Federal employment benefits, Medicare, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. visited Ohio this week as part of his “Take Back Your Health” tour. He met with the CEOs of the Cleveland Clinic, University Hospitals, and MetroHealth—three of the nation’s leading health systems—following a tour of the Cleveland Clinic. He also visited a Head Start program, a regenerative farm, and an addiction recovery facility, spoke at the City Club of Cleveland, and spent an afternoon at Summa Health. The tour highlighted the Secretary’s commitment to a prevention-first approach to healthcare as the pathway to Make America Healthy Again.
    • “Across Ohio, I saw communities move beyond symptom management and confront the root causes of disease head-on,” said Secretary Kennedy. “From visiting local programs to meeting with the CEOs of the Cleveland Clinic, University Hospitals, MetroHealth, and Summa Health, we are aligning leaders at every level around a prevention-first approach to reverse the chronic disease epidemic and deliver on President Trump’s mandate to Make America Healthy Again.”

  • FedSmith points out,
    • “In late 2025, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for Contract Year 2027, outlining significant changes to Medicare Advantage (Part C) and the Medicare prescription drug program (Part D).
    • “While many federal retirees rely on FEHB coverage, Medicare decisions—especially around Part B and Part D—remain one of the most important and misunderstood planning areas. This proposed rule signals where Medicare is heading next—and what federal retirees should be watching now.”
    • The article explains these changes.
  • Federal News Network reports,
    • “Despite some hiring occurring across agencies, overall employment in the federal government is continuing to decline. That’s according to the latest jobs report from the Bureau of Labor Statistics. BLS reported that in April, federal employment numbers decreased by another 9,000 jobs. Since peaking in October 2024, the federal sector’s numbers are now down by 11.5%, or 348,000 jobs.” 
  • STAT News relates,
    • “Two years ago, my old pal Rachel Cohrs Zhang and I reported how Medicare’s actuaries predicted the new Alzheimer’s drug Leqembi would cost the program $3.5 billion in 2025. It turns out that prediction was way off.
    • “Through the first three quarters of 2025, Medicare spent $139 million on Leqembi (made by Eisai and Biogen) and $74 million on Kisunla (a newer one made by Eli Lilly), federal data show. Together, that equals $213 million across 19,000 patients, and would be around $280 million for the entire year — a small fraction of the original estimate. Uptake for the drugs has been so muted that Medicare is not forecasting significant spending on them in 2026 or 2027.
    • “Predicting the myriad health care needs for a pool of 70 million older adults and people with disabilities is not an easy task. But neurologists and policy experts told me the lower-than-expected spending lines up with the challenges that have faced the Alzheimer’s drugs since their approvals: The intravenous medications are not easy to administer and require a lot of imaging; the population of patients who are eligible is limited; and the drugs continue to have little meaningful benefits while carrying a risk of severe side effects like brain bleeding.
    • Read Bob Hermans’ new story to learn more
  • and
    • “Changes to the no surprise billing law’s controversial arbitration process could come at any moment. Doctors and other providers are getting a lot more face time with the federal officials writing the regulations, my colleague Tara Bannow reports in a new story.
    • “Health insurers say providers are abusing the system by ramming through high volumes of ineligible cases. Providers claim insurers are not paying up when they lose and don’t give enough information. Ultimately, providers are winning more than 80% of cases, getting arbitration awards that are three to nine times the in-network rates. 
    • Read Tara’s story to find out the lobbying pitches from R1, Radiology Partners, the Blues, and employer groups.”

From the Food and Drug Administration front,

  • Beckers Hospital Review tells us,
    • “The fate of FDA Commissioner Marty Makary, MD, remained unclear May 11 after multiple news outlets reported May 8 that President Donald Trump had signed off on a plan to oust him — reports the president publicly waved off the same day.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions. 
    • “Identifying potential new uses—such as a new indication or a new population—for FDA-approved drugs can help accelerate the availability of treatments by using existing knowledge about the drugs, including a drug’s safety profile. This request for public input is part of a broader FDA initiative to update the labeling of FDA-approved drugs, when supported by sufficient evidence, to ensure that information in the labeling is clinically meaningful for health care providers and patients and scientifically up to date.”
  • MedPage Today informs us,
    • “The FDA on Friday [May 8] issued guidance for manufacturers collecting postmarketing data on the safety of approved drugs and biologics in pregnancy, with the goal of better understanding potential risks for the pregnant patient and fetus.
    • “Currently many medical products may be recommended to pregnant women by healthcare providers in spite of the fact that data from the clinical trials used for FDA approval were insufficient to assess safety during pregnancy,” Tracy Beth Hoeg, MD, PhD, the agency’s top drug regulator, said in a press release “This guidance provides specific recommendations about how postmarketing data can be leveraged and studies can be designed so clinicians and the public can be better informed about product safety and pregnancy-related risks can be more promptly identified.”
  • NBC News reports,
    • “The Food and Drug Administration removed the black box warning from hormone replacement therapies late last year, and recently, the most insured type, the estrogen patch, has been in short supply amid a boom in the therapy’s popularity.
    • “it’s unclear when supplies will rebound. Meanwhile, there are other options for hormone replacement therapy.”
  • Fierce Pharma lets us know,
    • “Argenx is poised to expand the reach of its generalized myasthenia gravis (gMG) treatment Vyvgart and subcutaneous Vyvgart Hytrulo with an expanded FDA nod that covers a wider pool of disease serotypes. 
    • “The label expansion now covers “all serotypes of adult patients living with gMG,” including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive and triple seronegative gMG, argenx said. In the company’s phase 3 Adapt Seron study, the overall population of Vyvgart-treated patients experienced “rapid, significant and sustained improvements” in symptoms including speech, vision, physical function and other disease measures.” 
  • and
    • Roche’s intravenous-infused relapsing-remitting multiple sclerosis (RRMS) treatment Ocrevus scored a pediatric indication from the FDA, clearing the therapy for patients 10 and older and introducing a new treatment option to the underserved population. 
    • The agency based its approval on a clinical trial comparing Ocrevus to Novartis’ Gilenya (fingolimod), which was until now the only FDA-approved pediatric RRMS treatment. In the study, Ocrevus proved noninferiority to Gilenya in reducing patients’ annualized relapse rate and superiority in reducing new or enlarging T2 lesions and gadolinium-enhancing T2 lesions. 

From the public health and medical / Rx research front,

  • The Wall Street Journal shares what the Journal “knows about hantavirus drugs and vaccines in development.”
  • The New York Times reports,
    • “For about a decade, scientists have had remarkable success curing some blood cancers by modifying a patient’s own immune cells to recognize and kill the malignant cells.
    • “That same approach may help control H.I.V., among the wiliest of viruses, scientists will report on Tuesday. After a single infusion of immune cells engineered to recognize the virus, two people in a new study have suppressed their H.I.V. to undetectable levels, one of them for nearly two years.
    • “The data is scheduled to be presented at a gene therapy conferencein Boston, but the researchers shared an early copy with The New York Times.
    • “The treatment is years, if not decades, from being widely available, but the study offers what scientists call “proof of concept,” and the tantalizing hope that a single shot could one day offer lifelong relief from H.I.V.
    • “It is inspiration and a potential road map to get to where we need to go,” said Dr. Steve Deeks, an H.I.V. expert at the University of California, San Francisco, who led the trial.
    • “Other scientists were enthusiastic about the milestone.”
  • Radiology Business relates,
    • “Vigilance is needed to ensure patient safety in pediatric MR imaging, experts warn in new research published Friday by JACR. 
    • “Safety events remain relatively common in pediatric imaging, though most do not result in significant patient harm. However, these occurrences have the potential for serious consequences for patients, their parents or guardians, and MRI staff. 
    • ‘The conclusions are based on an analysis of safety data from five leading pediatric hospitals, spanning 2017 to 2022. Over the course of five years, there were about 146 pediatric MRI safety incidents that occurred, out of nearly 541,000 scans conducted. 
    • “Although uncommon, MRI safety incidents do occur in Zone IV of pediatric imaging departments,” corresponding author Jonathan R. Dillman MD, MSc, with the Department of Radiology at Cincinnati Children’s Hospital, and colleagues concluded. “While most cause no serious harm, their persistence and potential for catastrophic outcomes highlight the need for continued vigilance and ongoing safety improvements.”
    • “Zone 4 refers to the MRI scanner room, which presents the greatest risk of harm for both patients and staffers.” 
  • Med City News considers “Why We’re Still Finding Cancer Too Late>’
    • “The truth is there are ways to understand our cancer risk more precisely than we do today, and there are tools to manage it. What’s missing is awareness, access, and a system built to help us use these tools before something goes wrong.” * * *
    • “Healthcare innovators are shifting how we define and assess cancer risk, but education on evidence-based screening and risk-reduction practices needs to be front and center alongside these efforts so fewer people will ever have to say, “I wish I knew earlier.” Just like treatment options, prevention is not “one size fits all,” but a highly personalized approach. Individuals today can understand their risk of cancer far more clearly than any prior generation and, with the right information, resources, and support, can take powerful steps to reduce it. It won’t happen automatically. Our system is built to react to disease rather than anticipate it, which means personalized prevention rarely starts unless providers and patients help initiate it. 
    • “Instead of waiting for a cancer diagnosis, it’s time to ask the question: “What is this patient’s personal risk of cancer, and what can we do, starting now, to lower it and increase their chances of catching it early?”
  • A National Institutes of Health press release adds,
    • “Findings from a study supported in part by the National Institutes of Health (NIH) have identified a new model for predicting outcomes for hypertrophic cardiomyopathy (HCM), a heart condition with a prevalence of 1 in 500 people and a frequent cause of sudden cardiac death. Specifically, the findings demonstrate that incorporating prospective data including clinical history, imaging, and blood biomarker data into risk assessment can improve prediction of adverse cardiac events in people with HCM.
    • “The large, international study, called the Hypertrophic Cardiomyopathy Registry, was initially funded by NIH’s National Heart, Lung, and Blood Institute (NHLBI). The findings were published in JAMA.
    • “Current risk prediction guidelines for hypertrophic cardiomyopathy are imperfect, as they predict only sudden cardiac death, and not heart failure or other fatal and nonfatal cardiac adverse events,” said Christopher Kramer, M.D., a principal investigator of the study and cardiologist at the Heart and Vascular Center of the University of Virginia Health System. “This study is a major advance in that it provides evidence that incorporating these additional assessment methods better predicts risk of adverse outcomes.”
  • Health Day tells us,
    • “People hospitalized for opioid overdose have a higher rate of subsequent OD than previously thought, a new study says.
    • “Previously, it was estimated that about 6% of people who survived an opioid overdose wound up with a repeat overdose during the following year.
    • “But new results indicate that 21% experience a repeat OD after an emergency department visit for opioid overdose, researchers reported May 7 in the Journal of the American Medical Association.
    • “Patients’ risk of death also increased alongside their number of additional overdoses, the study found.
    • “Increased use of powerful synthetic opioids like fentanyl are fueling the rising risk of repeat overdose, researchers said.”
  • and
    • “Exposure therapy can successfully protect preschool children from peanut allergies, a new study says.
    • “Children ages 1 to 3 fed small amounts of peanut daily slowly became accustomed to them, researchers reported May 6 in The Lancet Regional Health Europe.
    • “All children who followed the protocol achieved the goal of eating three and a half peanuts without experiencing an allergic reaction, and most were able to consume up to 25 peanuts,” researcher Caroline Nilsson said in a news release. Nilsson is an associate professor of clinical science and education at the Karolinska Institute in Sweden.
    • “We consider the treatment to be safe if it is carried out under controlled conditions in a healthcare setting,” she said.”
  • MedPage Today points out,
    • “Human papillomavirus (HPV) vaccination rates varied substantially across and within U.S. regions, according to estimates in a retrospective, cross-sectional analysis, suggesting targeted interventions should focus on the needs of individual states.
    • “Comparing adolescents ages 13-17 years across the country against Alabama — where the 21% without at least one dose of the HPV vaccine approximates the national goal — several Northeast states did significantly better, including Rhode Island (adjusted OR 3.05, 95% CI 1.40-6.66), Massachusetts (aOR 2.19, 95% CI 1.24-3.88), and New Hampshire (aOR 1.72, 95% CI 1.03-2.88).
    • “Several Southern states significantly lagged Alabama in likelihood of HPV vaccination, including Mississippi (aOR 0.41, 95% CI 0.26-0.65), Georgia (aOR 0.45, 95% CI 0.27-0.76), Oklahoma (aOR 0.46, 95% CI 0.30-0.72), Kentucky (aOR 0.55, 95% CI 0.35-0.87), and West Virginia (aOR 0.56, 95% CI 0.36-0.87), reported Chinenye Lynette Ejezie, PhD, of Towson University in Maryland, and colleagues in a JAMA Pediatricsopens in a new tab or window research letter.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For decades, physicians and scientists have thought that metformin, a biguanide drug that is prescribed for millions of people worldwide for type 2 diabetes (T2D), mainly targets the liver to suppress glucose production. A Northwestern University-led study in mice has now found that this “wonder drug” instead acts primarily on the gut, and prevents glucose levels from rising in the blood by driving glucose utilization inside cells lining the intestine.
    • “The research found that metformin slows mitochondrial energy production in gut cells by inhibiting mitochondrial complex I in the intestinal epithelium. This then “co-opts” the intestines to function as a glucose sink, forcing the intestine to metabolize extra sugar. The study also found that another biguanide drug, phenformin, and the structurally unrelated supplement berberine, which is known as “nature’s Ozempic,” appear to engage the same pathway in the gut as does metformin.
    • “The preclinical findings could help to explain several gut-related clinical effects in people who take metformin and suggest that modulating mitochondrial metabolism in the gut may represent an effective strategy for controlling blood sugar. “Metformin essentially helps the intestine suck the glucose out of the bloodstream, which further highlights that the gut plays a major role in regulating blood sugar levels,” said corresponding author Navdeep Chandel, PhD, professor of biochemistry and molecular genetics at Northwestern University Feinberg School of Medicine.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente’s first-quarter operating performance took a step back in 2026 compared to the year prior, though investments and other sources of income picked up the slack to push the large integrated nonprofit’s bottom line past $2 billion. 
    • “The system reported operating income of $711 million for the quarter, or a 2.1% operating margin, in a Friday evening press release. It had logged $932 million in operating income, or a 2.9% operating margin, in the first three months of 2025.
    • “The organization’s performance came on the back of $34.6 billion in consolidated operating revenue, a roughly 8.7% year-over-year increase, and $33.9 billion of operating expenses, a 9.6% year-over-year increase.
    • “Though it grew in scale, Kaiser noted that it and its subsidiary Risant Health “continue to manage elevated costs in care delivery while taking steps to improve efficiency and maintain affordability.” 
  • and
    • “Omada Health reported revenue of $78 million in the first quarter, up 42% year over year as the company continues to expand its commercial reach and is seeing traction from its big investments in GLP-1 capabilities.
    • ‘The virtual chronic care provider reported strong adoption of its GLP-1 Care Track program while the company also continues to successfully sell multiple chronic condition programs to its existing customer base of employers and health plans, executives said during the company’s Q1 earnings call on Thursday.
    • “Q1 was the strongest first quarter in Omada’s history; on members, on revenue, on gross margin and on adjusted EBITDA,” Steven Cook, Omada Health’s chief financial officer, said during the earnings call. “Over the past year, we have been building capabilities to position Omada for durable growth, prescribing infrastructure, AI-empowered care delivery and an expanding set of GLP-1 and cardiometabolic solutions.”
  • Modern Healthcare relates,
    • “UnitedHealth Group Inc. said it will move away from having profits in its pharmacy benefits unit linked to the list prices of medications, the latest shift to address longstanding criticisms of its business model.
    • “Optum is UnitedHealth’s services arm. UnitedHealth’s Optum Rx unit helps determine which drugs are covered by health insurance plans, including UnitedHealthcare’s and others, and what prices patients must pay to access them. The company handled about 1.7 billion prescriptions last year.
    • “Optum Rx plans to shift to what a top executive called a more transparent fee structure that gives clients clarity into the money it gets from drugmakers. The way those details have been determined has been shrouded in secrecy, leading to claims that Optum Rx benefits from higher drug prices. The new approach is designed to refute those criticisms.” * * *
    • “We want our earnings based on service to the client,” Optum Chief Executive Officer Patrick Conway said in an interview. “We do not want any of those earnings tied to the list price of drugs, period.”
    • “The shift is expected to be complete by the end of next year, Conway said. It’s part of a series of changes the company is making to transform a business model that’s faced criticism from regulators, employers and lawmakers.”
  • The Wall Street Journal tells us,
    • “AstraZeneca is inching closer to its goal of reporting $80 billion in revenue by 2030 as the U.K. drugmaker pushes further into the U.S. and develops new oncology, rare disease and weight-loss drugs.
    • “The pharmaceutical giant has made progress on a pipeline of more than 25 medicines, each expected to generate more than $1 billion in revenue by the close of the decade, Chief Financial Officer Aradhana Sarin said. AstraZeneca hopes those drugs, along with new U.S. manufacturing investments and a direct listing of its shares in New York, will fuel growth.
    • “Revenue has been on the upswing since the company set its $80 billion target in 2024, with 2025 coming in at $58.74 billion. That was up from $45.81 billion in 2023, the year before it set the 2030 target.”
  • Beckers Health IT informs us,
    • “Whoop is rolling out new features to include virtual clinician visits and EHR integration.
    • The Boston-based fitness wearable company announced the updates May 8, positioning the new offerings as part of its broader shift from fitness and performance tracking toward clinical-grade health support, according to a Whoop news release.
    • “The new offerings include live, on-demand video consultations with licensed clinicians, which are expected to launch in the U.S. this summer. Whoop said the feature will allow members to connect with clinicians directly through the app, using months of biometric data, and when available, bloodwork and medical history, to provide a more comprehensive understanding of a member’s health.
    • “Whoop also announced plans to support electronic health record syncing through a partnership with HealthEx. The integration will allow members to access clinical information, including diagnoses, medications and procedures, directly within the app.”
  • Healthcare Dive notes,
    • “An influential group that advises Congress on Medicaid is recommending increasing transparency into artificial intelligence-backed prior authorization and boosting human oversight over automated pre-approvals for care. 
    • “The recommendations come as states and the federal government say they have limited insight into payers’ use of the technology in the safety-net insurance program, which can make it challenging for regulators to monitor for data bias or inaccuracies, analysts said during the meeting.”
  • Tech Target adds,
    • “The Workgroup for Electronic Data Interchange launched a free directory for organizations seeking testing partners for the CMS Advancing Interoperability and Improving Prior Authorization Final Rule (CMS-0057-F), in advance of the Jan. 1, 2027, compliance deadline. WEDI encouraged all organizations impacted by the rule to post their information on the directory and use it to test APIs with eligible partners.
    • “CMS-0057-F requires entities to implement certain HL7 FHIR APIs: Prior Authorization, Payer-to-Payer, Patient Access and Provider Access. The Prior Authorization API can identify documentation requirements for prior authorization approval, while the Payer-to-Payer API enables the exchange of claims and encounter data. The Patient Access API allows patients to access their health information, and the Provider Access API allows payers to share patient data with in-network providers.” * * *
    • “Organizations that want to test can complete a questionnaire that includes contact information, specific APIs available for testing and a link to their website. Organizations can also look for testing partners using the directory and contact the organizations they want to test with. The directory will display summaries of completed testing.
    • “At the time of publication, six entities had posted their information on the directory: Wellmark, Mayo Clinic, Veradigm, Blue Cross Blue Shield of Michigan, NextGen Healthcare and ZeOmega.”


Friday report

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

From Washington, DC,

  • Federal News Network reports
    • “Nearly 12,000 new retirement claims entered the Office of Personnel Management’s systems last month. Coupled with OPM’s processing of about 17,000 retirement applications, the agency managed to reduce its inventory by several thousand claims. April was the first time OPM’s retirement backlog has dipped below 50,000 claims in more than five months. Currently, digital retirement claims are also being processed in about two-thirds the time of traditional paper applications.”
  • and
    • “Democrats are urging the Office of Personnel Management not to shut down the Combined Federal Campaign. In a letter to OPM this week, lawmakers warned that ending the CFC would be “disastrous” for hospitals, food banks and other organizations that receive charitable donations through the program. OPM recently decommissioned the CFC’s online donation portal, but the agency has not yet confirmed whether the program will be officially dismantled this year. CFC has been in operation since the Reagan administration, a program that lets federal employees contribute to charities around the world.”
  • The Wall Street Journal relates,
    • “The CDC is coordinating with the WHO on a hantavirus outbreak aboard the MV Hondius, despite the U.S. withdrawal from the WHO and CDC cuts.
    • “The U.S. formally withdrew from the WHO earlier this year, following President Trump’s executive order and criticism of its Covid-19 handling.
    • “The Trump administration reduced funding for CDC global health programs, shifting to a fee-for-service model for technical assistance.”
  • KFF Health offers more details on CMS’s Bridge program which will give eligible Medicare beneficiaries access to GLP-1 drugs for weight loss. The Bridge program runs from July 1. 2026, through December 31, 2027.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “President Trump has signed off on a plan to fire Food and Drug Administration Commissioner Marty Makary, according to people familiar with the matter, following a tumultuous period for the regulator that included clashes over vaping, abortion and drug policy.
    • ‘Makary, a former Johns Hopkins surgeon who became a frequent Make America Healthy Again surrogate on television news programs, is seen by other top administration leaders as struggling to manage his agency, sparring frequently with health department officials and at times with the White House. His tenure has also been dogged by the aftereffects of layoffs led by the Department of Government Efficiency and rapid turnover in the FDA’s leadership ranks. 
    • ‘He would become the latest top lieutenant fired under Health and Human Services Secretary Robert F. Kennedy Jr. since the ouster last summer of Centers for Disease Control and Prevention Director Susan Monarez and the February removal of HHS Deputy Secretary Jim O’Neill.
    • “Trump’s plan isn’t yet final and could change.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after identifying a software-related battery issue that could cause affected devices to enter Safety Mode and limit pacing functionality. The correction does not involve removing devices but requires clinicians to upgrade the pacemakers’ software to reduce the risk of premature battery depletion and early device replacement. According to the FDA, continued use of affected devices without the update could result in serious injury or death. Hospitals and clinicians are advised to review affected model and serial numbers, apply the software update during in office visits, monitor patients per manufacturer guidance and report adverse events through the FDA’s MedWatch program.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts. 
    • “Bizengri is the first drug approved for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
    • “This approval marks the seventh approval under the Commissioner’s National Priority Voucher (CNPV) pilot program.”
  • Fierce Pharma tells us,
    • “While Eisai and Biogen have already secured an FDA nod for a subcutaneous maintenance dose of their early Alzheimer’s disease drug Leqembi (lecanemab), the partners will have to wait a few months more for the regulator to weigh in on their proposed autoinjector initiation dose. 
    • “On Friday, the companies announced that the FDA has extended the review period for their application to advance their Leqembi Iqlik autoinjector as a starting dose for early Alzheimer’s patients. The three-month delay puts the FDA’s new target action date at Aug. 24, Biogen and Eisai said in a release.”
  • Beckers Hospital Review identifies seven prescription drugs now in shortage.
    • “Active drug shortages in the U.S. rose for the second consecutive quarter in 2026, reaching 223 in the first quarter, according to a recent report from the American Society of Health-System Pharmacists. Meanwhile, the FDA’s own database — which uses a narrower classification — lists 76 drugs currently in shortage, as of May 6.
    • “The database is updated daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
  • Here’s a link to “Brown & Brown’s May 6, 2026, PharmaLogic® Spotlight [which] reviews evolving pharmacy dynamics and trends driving prescription drug use and cost to guide benefits decision-making.”
    • “Inside this PharmaLogic® Spotlight
      • “New Drug Approvals Influencing Benefits
      • “GLP-1 Developments
      • “Drug Importation/International Sourcing
      • “Generic and Biosimilar Use
      • “Shifts in Drug Pricing Models”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today:
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is decreasing and has peaked in most regions of the country.
    • “Seasonal influenza activity is low.
    • “COVID-19 activity is low in most areas of the country.
    • “Nationally, wastewater activity levels for RSV, COVID-19 and influenza A are very low. Influenza B is not monitored in wastewater.”
  • The American Hospital Association News adds,
    • “The measles outbreak in Utah that began in June 2025 has grown to 638 cases as of May 5, according to the state’s Department of Health and Human Services. Of those, 441 have been reported this year. Nationally, there have been 1,842 confirmed measles cases in 2026, according to the Centers for Disease Control and Prevention. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape reports,
    • “Once weekly semaglutide injections reduced alcohol consumption in patients with alcohol use disorder (AUD) and comorbid obesity.
    • “Results of the randomized controlled trial (RCT), the first, to the authors’ knowledge, to evaluate the GLP-1 receptor agonist (GLP-1RA) semaglutide in patients seeking treatment for AUD who had comorbid obesity also showed significant effects on multiple alcohol-related outcomes.
    • “These data, when added to the growing evidence, demonstrate the potential of GLP-1RAs as a novel treatment for alcohol use disorder,” the investigators, led by Mette Kruse Klausen, MD, Copenhagen University Hospital in Copenhagen, Denmark, wrote.
    • “However,” they added, “corroboration with larger RCTs in nonobese patients is needed to address its generalizability.”
  • and
    • “GLP-1 receptor agonists may alter absorption of oral medications due to delayed gastric emptying, affecting drug levels and efficacy. Notable interactions include oral contraceptives, levothyroxine, and dabigatran, necessitating careful monitoring and potential dose adjustments.”
  • Health Day relates,
    • “People recovering from surgery have an easy way to boost their odds of a successful recuperation — take a stroll.
    • “Every extra 1,000 steps a patient takes daily after surgery lowers their odds of complications, researchers reported May 6 in the Journal of the American College of Surgeons.
    • “This link between extra steps and better recovery applied across different types of procedures regardless of the patients’ overall health, researchers found.
    • “Researchers discovered this after tracking nearly 2,000 people undergoing inpatient surgery who wore activity trackers while undergoing inpatient surgery.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “UnitedHealthcare has begun paying some commercial claims instantly, bypassing the standard three to five day window associated with traditional ACH transactions, the insurer said May 4.
    • “Under the new system, eligible commercial claims payments are deposited immediately into providers’ bank accounts, with remittance data routed through clearinghouses to providers’ tax identification numbers.
    • “UnitedHealthcare did not specify which claims or plan types qualify for real-time payment. The payments are not processed through Optum and will not appear on the Optum Pay platform.
    • “Providers do not need to take action to receive the payments, but UnitedHealthcare said some may need to update reconciliation workflows.” 
  • Kaufmann Hall notes,
    • “Americans are increasingly making serious trade-offs that impact their health and daily lives to afford health expenses, according to a recent report from West Health-Gallup Center on Healthcare in America. About 30% of insured and 62% of uninsured Americans—across income brackets—have made at least one or more difficult trade-off: prolonging their prescription, skipping a meal, cutting back on utilities or borrowing money. A third reported postponing vacations and surgical and medical treatment alike. These trade-offs are not “nice to have.” Not taking medication as prescribed, skipping meals, cutting back on utilities especially during extreme weather, and delaying surgical and medical treatment carry serious medical risk for harm that leads to increased ED visits, readmissions, and other avoidable costly care that may impact hospitals and health systems.
  • MedCity News relates,
    • “As patient payment responsibility grows and becomes a larger part of the overall care experience, payment decisions need more visibility across the organization, not just in finance or IT. 
    • “Healthcare organizations should begin with a practical review that includes: which payment methods are accepted at every point of care, whether FSA, HSA, and Medicare card configurations are validated across systems, where declines are occurring and why, and how long it takes patients to move from statement to payment. 
    • “Payment friction isn’t always obvious. It shows up in extended accounts receivable timelines, increased billing inquiries, and patients who delay payment – not because they’re unwilling to pay, but because the process made it harder than it needed to be. As patients become responsible for more of the bill, consistency matters. The payment process should be predictable across settings and straightforward to navigate.
    • “Payment systems may not determine whether care is delivered. But as more financial responsibility shifts to patients, they increasingly influence how that care is experienced.”
  • Modern Healthcare tells us,
    • “Sanford Health is looking to expand its Minnesota network in one of the state’s fastest-growing regions. 
    • “Sanford and North Memorial Health signed a definitive agreement to add North Memorial’s two hospitals and affiliated facilities in northwest Minneapolis to Sanford’s 58-hospital footprint, according to a Friday news release. * * *
    • “Under the agreement, Sanford pledged to update emergency services at the financially strained safety-net hospital North Memorial Health Robbinsdale. Sanford also said it plans to help double the size of North Memorial Health Maple Grove Hospital by expanding emergency care, inpatient services, surgeries and labor and delivery care. 
    • “The proposed transaction is expected to close this year, pending customary regulatory approvals.”
  • Beckers Hospital Review points out,
    • “Between the fourth quarters of 2024 and 2025, emergency department length of stay decreased 13.4% even as volumes grew 4.2% and patient acuity rose, according to a May 6 report.
    • “The report is from Sg2, a healthcare analytics and consulting company at Vizient. Through its System of CARE Scorecard, Vizient measures hospital utilization, access, safety and cost efficiency each quarter. Its latest scorecard compared the fourth quarters of 2025 and 2024 for care coordination. 
    • “On a rolling year-over-year measure, ED length of stay declined 15.2% and volume increased 4.3%, according to the report. Vizient researchers hypothesized that improvements in throughput, shifting trends in patient mix or a combination of the two could be account for these findings.” 
  • Fierce Healthcare informs us,
    • “Amazon Pharmacy will make Novo Nordisk’s Ozempic pill available for home delivery, the company announced Thursday.
    • “Per the announcement, Amazon customers will be able to secure the oral GLP-1 medication via same-day delivery or pickup within minutes at its kiosks in short order. The drug, which is approved to manage blood sugar in individuals with type 2 diabetes, was originally sold as Rybelsus but was recently rebranded to Ozempic by Novo.
    • “Amazon said that making the drug available via its pharmacy will address “a critical access gap for the more than 36 million Americans living with type 2 diabetes.”
    • “Individuals with a prescription for oral Ozempic can order the drug through Amazon Pharmacy as well as access key availability and transparent pricing data, even if they are not Prime members, the company said. Pricing is as low as $25 per month with insurance coverage.”
  • The Wall Street Journal lets us know,
    • “Sandoz Group plans to launch its generic semaglutide in Canada and Brazil this year, following patent expiration in several countries.
    • “Sandoz Chief Executive Richard Saynor stated the generic weight-loss drug market size is unknown, with initial years focused on supply.
    • “Analysts forecast Sandoz’s generic semaglutide sales to reach $742.6 million in 2035, as the overall market expands.”
  • Per MedTech Dive,
    • “Stryker has completed the acquisition of Amplitude Vascular Systems, less than a month after the deal was announced. The financial terms were not disclosed.
    • “Amplitude has developed the Pulse intravascular lithotripsy platform to treat severely calcified arterial disease. The device uses pressure waves generated by carbon dioxide and delivered through a balloon catheter to fracture the calcium and expand narrowed vessels, restoring blood flow.
    • “Stryker said adding an IVL platform will strengthen its peripheral vascular portfolio, which includes the Inari Medical clot-removal business the company acquired last year for about $4.9 billion.”

Monday report

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

From Washington, DC,

  • Per a Senate news release,
    • “The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee will hold two field hearings in Louisiana this week to discuss how Congress can make health care affordable and improve mental health and substance use disorder treatment. The Committee will hear from a variety of perspectives within the health care system, including patients, providers, and local subject matter experts.” * * *
    • “Title: Making Health Care Affordable Again Part 2: Perspectives from Employers, Patients, and Providers
    • “Date: Tuesday, May 5, 2026
    • “Time: 9:00 AM CT/10:00 AM ET
    • “Location: LSU Foundation Building, 3796 Nicholson Drive, Baton Rouge, LA
    • “Click here to watch this hearing live.”
  • The Wall Street Journal reports,
    • “Health Secretary Robert F. Kennedy Jr. is announcing steps that he said are aimed at helping wean some Americans off psychiatric medications, including antidepressants.
    • “Too many patients begin treatment without a clear understanding of the risks, and how long they will stay on these drugs, or how to come off them,” he said to an audience at an event hosted by the Make America Healthy Again Institute, a nonprofit, on Monday. “We are going to fix it.” 
  • Here is a link to the HHS news release about this announcement.
  • Per U.S. Office of Personnel Management news releases,
    • “The US Office of Personnel Management (OPM) today recognized Public Service Recognition Week, honoring the federal employees who serve the American people every day and highlighting the critical role public servants play in delivering results for taxpayers.
    • “Observed annually during the first full week of May, Public Service Recognition Week celebrates the dedication, professionalism, and impact of public servants across the federal government and at all levels of public service. This recognition also comes as OPM continues its work to strengthen the federal workforce through modern hiring, performance management, and workforce development initiatives.”
  • and
    • “The US Office of Personnel Management (OPM) today announced the expansion of access to USA Class, an artificial intelligence (AI)–enabled tool designed to accelerate the creation of federal position descriptions, to all federal agencies using USA Staffing at no additional cost.
    • “This move integrates USA Class directly into the federal government’s primary hiring platform, providing hiring managers and human resources professionals with modern tools to reduce administrative burdens and speed the hiring process.
    • “USA Class uses AI technology trained on thousands of existing federal position descriptions to help managers quickly generate structured draft duties and assist classifiers in aligning those duties with OPM classification standards. The tool is designed to strengthen collaboration between managers and classifiers, reduce rework, and significantly shorten timelines needed to prepare position descriptions, an essential first step in the hiring process.”
  • OPM Director Scott Kupot discusses the USA Class initiative in the latest post in his Secrets of OPM blog.
    • “Don’t get me wrong – hiring is still hard, and I don’t suspect AI will fully solve that problem in the near term. But we are using AI to streamline the tasks for which computers are very capable and free up time for HR professionals and hiring managers to focus on the people-facing aspects of recruiting and assessing candidates. More to come.”
  • Fierce Healthcare offers “A deeper dive into the ACCESS Model—Who’s participating, potential headwinds and how it could spur health plan adoption.”
    • “The CMS ACCESS Model creates a new category of Medicare Part B providers, ACCESS organizations, that can receive outcome-aligned payments for managing qualifying chronic conditions. The model shifts away from remote patient monitoring (RPM) and chronic care management (CCM) billing codes that offer payments for specific activities.
    • “This access model introduces an alternative approach, which is, you get rid of the billing codes altogether, and you have these new outcomes-aligned payments,” said Aneesh Chopra, chair of the Arcadia Institute.
    • “Chopra, who served as the first U.S. Chief Technology Officer, asserts that the ACCESS model redefines value-based care as it eliminates complexity and makes value-based care scalable.
    • “The use of AI technologies enables companies and providers to take a scarce resource—care management—and make it abundant, Chopra noted, to scale it to more patients living with chronic conditions.”
  • Healthcare Dive relates,
    • “The Department of Justice’s fraud division last week launched a strike force dedicated to rooting out healthcare fraud on the West Coast, as the Trump administration continues to double down on fraud enforcement across the country. 
    • “The West Coast Health Care Fraud Strike Force brings the DOJ’s healthcare fraud unit together with the U.S. attorney’s offices for Arizona, Nevada and the Northern District of California, to coordinate on cases in the region, according to a Thursday press release. 
    • “The strike force will bring increased enforcement resources to Northern California — one of the nation’s hubs for health technology development — and Arizona and Nevada, where the DOJ says healthcare fraud schemes are rising.” 

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Incyte is poised to expand the reach of its blockbuster JAK inhibitor Jakafi with a new once-daily, extended-release version that’s soon to hit pharmacy shelves. 
    • “The FDA signed off on Jakafi XR under the same indications as original Jakafi, allowing its use to treat intermediate or high-risk myelofibrosis, polycthemia vera and graft-versus-host disease. In a bioequivalence study, a single 55-mg Jakafi XR tablet exhibited consistent, day-long exposure comparable to a twice-daily 25-mg immediate-release Jakafi dose. 
    • The new version allows for expanded treatment options “without changing the well-established role of Jakafi in clinical practice,” Incyte’s CEO Bill Meury explained in a company release.”
  • and
    • “Along with partner Lannett, a subsidiary of China’s Sunshine Lake Pharma has brought a biosimilar of Sanofi’s insulin glargine Lantus to the U.S., adding a cheaper interchangeable option to the diabetes treatment landscape. 
    • “The green light makes Lannet and Sunshine’s product the first long-acting insulin from a Chinese company to win the FDA’s blessing. 
    • “The biosimilar will be sold under the brand name Langlara and is now FDA-approved to treat adult and pediatric patients with type 1 diabetes as well as adults with type 2 diabetes. Langlara also received an interchangeable designation from the FDA, meaning that it can be distributed by pharmacists in place of Lantus without sign-off from a physician.”   

From the judicial front,

  • Per a Department of Justice news release,
    • “Two men were sentenced today for their roles in a scheme to defraud Medicare, Medicaid, and private health insurance companies by submitting over $522 million in fraudulent claims for medically unnecessary genetic tests that were obtained through the payment of illegal kickbacks and bribes.
    • “Reyad Salahaldeen, 57, of Buford, Georgia, was sentenced to 151 months in prison after pleading guilty to conspiracy to commit health care fraud and wire fraud. Mohamad Mustafa, 28, of Duluth, Georgia, was sentenced to three years in prison after pleading guilty to paying health care kickbacks.
    • “Under the guise of health care, these two fraudsters attempted to steal more than half a billion dollars from taxpayers through a web of sham contracts, lies, and bribes,” said Colin M. McDonald, Assistant Attorney for the National Fraud Enforcement Division. “These schemes deplete America’s pocketbook and destroy the trust in medicine that patients deserve and demand. The Department of Justice will remain vigilant in our efforts to deter those defrauding the American people in the name of health care. I thank the prosecutors and our law enforcement partners at FBI and HHS-OIG who worked tirelessly for this just outcome.”

From the public health and medical / Rx research front,

  • A neurologist, writing in the Washington Post, tells us about “six ways to keep work stress from fueling headaches.”
  • The American Medical Association lets us know what doctors wish their patients knew about Lyme Disease.
    • “An early sign of Lyme disease is a bullseye rash from a tick bite. But symptoms can worsen if left untreated. Three infectious diseases physicians share more.”
  • Cardiovascular Business reports,
    • “Long-term antidepressant use may increase a person’s risk of sudden cardiac death (SCD), according to new findings published in Heart Rhythm.
    • “SCD frequently occurs without warning, often in individuals without previously diagnosed cardiovascular disease,” wrote first author Jasmin Mujkanovic, MD, a cardiologist with Copenhagen University Hospital, and colleagues. “It accounts for a significant proportion of cardiovascular mortality worldwide. Psychiatric disorders have previously been shown to be associated with SCD, with major depressive disorders having a twofold increased risk … Pharmacologic treatment of depression, with antidepressants among the most common pharmaceuticals prescribed, adds another layer of complexity.”
  • MedPage Today relates,
    • “Kids seen by primary care clinicians for acute respiratory tract infections were prescribed antibiotics less often during telemedicine visits versus in-person visits in a cross-sectional study.
    • “The difference was driven by more telemedicine diagnoses of viral infections and sinusitis versus more in-person diagnoses of acute otitis media and streptococcal pharyngitis.
    • “There were no significant differences between groups in antibiotic management guideline concordance, follow-up visits, or antibiotic prescription within 14 days after the initial visit.”
  • and
    • “A 10% increase in ultraprocessed food intake was tied to lower attention scores and greater dementia risk in a cross-sectional study.
    • “The relationships persisted even in people who followed a Mediterranean diet.
    • “No relationship emerged between ultraprocessed food intake and memory scores.”
  • Health Day informs us,
    • “Antibiotics don’t appear to increase a person’s risk of developing celiac disease, a new study says.
    • “Patients with celiac disease had a 24% higher odds of antibiotic use compared to healthy siblings or members of the general public, researchers reported recently in the journal Clinical Gastroenterology and Hepatology. 
    • “However, the odds of antibiotic use were even higher — 50% — among a group of people whose gut lining was normal, when they were compared to the general public, researchers said.
    • “These results indicate that earlier studies that linked celiac disease to antibiotics reflect a heightened awareness of the disorder, in which the gut becomes inflamed if a person eats gluten.
    • “We do not see a causal link between celiac disease and antibiotics,” said lead researcher Dr. Maria Ulnes, a pediatrician and doctoral student at the University of Gothenburg in Sweden.”
  • Radiology Business points out,
    • “A new 4D mammography technique could diagnose cancer with up to four times the precision of 3D digital breast tomosynthesis (DBT) exams. 
    • “That’s according to early data out of an ongoing first-in-human clinical trial at Baptist Health Hardin in Elizabethtown, Kentucky. The trial is testing the utility of the 4D mammography system developed by Calidar Inc.—a medical technology startup out of North Carolina. Calidar’s 4D system harnesses X-ray diffraction imaging to measure molecular-level signatures of disease; these tissue “fingerprints” could help providers diagnose breast cancer in its earliest stages, but current mammography systems do not have this capability. 
    • “Calidar has indicated that its 4D system also allows for exams to be completed more quickly, and at a reduced radiation dose compared to 2D and 3D scans.” 

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

  • Beckers Payer Issues explains,
    • “Healthcare more broadly has been focused on reaching consumers where they are at. Health systems have established virtual care partnerships, and prescription drugs are now more accessible via direct-to-consumer pathways.
    • “But health insurers have also been developing strategies to reach members more directly, such as through transparent pricing and shifts in product offerings.”
    • The article offers several examples.
  • The Wall Street Journal reports,
    • UCB said it agreed to buy Candid Therapeutics [which is based in San Diego, CA] for up to $2.2 billion, in a deal that seeks to bolster the Belgian pharmaceutical company’s pipeline of experimental treatments for autoimmune and inflammatory diseases.
    • Brussels-based UCB said Sunday that it would pay $2 billion upfront and up to $200 million subject to future targets to acquire Candid. Its latest acquisition follows a licensing agreement with China’s Antengene valued at up to $1.18 billion in March, and a deal to buy epilepsy-therapy developer Neurona Therapeutics for up to $1.15 billion last month.
    • Privately held Candid is developing a portfolio of experimental drugs to treat autoimmune and inflammatory diseases and its lead candidate, cizutamig, is a so-called bispecific antibody being tested in multiple early-stage clinical trials across a number of indications, UCB said.
  • Fierce Healthcare relates,
    • “UPMC and CommonSpirit’s talks to hand over a three-hospital system in eastern Ohio have progressed to a definitive agreement between the parties with a transaction expected to close in the fall. 
    • “Financial terms of the deal for CommonSpirit’s Trinity Health System were not disclosed, and a close would require regulatory clearances.
    • “Trinity Health System and UPMC share a commitment to providing top-tier care and serving the most vulnerable members of our community,” Dwayne Richardson, interim president of Trinity Health System, said in a Monday release announcing the agreement. “UPMC’s proven track record of community service and compassionate approach to care were key factors in our decision, and will significantly benefit our patients.”
    • “Trinity Health System includes facilities for urgent care, behavioral health and physician offices alongside its hospitals. The deal reflects a market expansion for UPMC, which is based in Pittsburgh, Pennsylvania and dominates the western half of that state with more than 40 hospitals and 800 outpatient sites.” 
  • Radiology Business notes,
    • “It may be more than anxiety and forgetfulness to blame for women missing their scheduled mammograms, according to new survey data. 
    • “Missed breast imaging appointments are not uncommon. In fact, prior research has suggested that breast imaging appointments account for the largest number of no-shows in imaging. This can be problematic for both practices and patients, experts explain in a new paper in Academic Radiology.” * * *
    •  
  • Healthcare Dive tells us,
    • “Healthcare bankruptcies rose in the first quarter after declining last year, according to a report released last week by restructuring advisory firm Gibbins Advisors.
    • “Twelve healthcare companies with liabilities of at least $10 million filed for Chapter 11 bankruptcy protection in the first quarter, up 33% from the fourth quarter of 2025. 
    • “Senior care firms and physician practices drove bankruptcies in the first quarter, with four filings each.” * * *
    • “The most common reason for missing an exam was forgetting about the appointment, cited by 35% of respondents. Financial and logistical issues, however, also represented a significant barrier for many; 19% indicated that financial hardship prevented them from attending their appointment, while another 20% said they did not have transportation to get to their exam. Notably, respondents who fell under lower income brackets most often cited issues with payments and transportation. Notably, around 30% of the patients who missed their appointment never rescheduled. 
    • “In terms of improving follow through, respondents suggested that more frequent reminders would be beneficial; the majority signaled that text message reminders were the most effective. Other suggestions included some form of payment assistance and transportation services.”  
  • Joanna Stern writing in the Wall Street Journal describes a personal experience with AI enhanced mammography.
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) posted a Protocol today outlining how it will conduct its second annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group* consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies. 
    • “In the upcoming report, to be released in October 2026, ICER will analyze launch price trends over four years (2022-2025). ICER is also conducting an in-depth review of newly launched drugs (July 2024 to June 2025 novel drug approvals) by:
      • “Evaluating the impact of pricing above ICER’s Health Benefit Price Benchmark (HBPB)† for drugs that ICER has previously reviewed.
      • “Evaluating patient access to newly launched drugs using real-world pharmacy and medical claims data, payer coverage policies, and direct patient surveys.
    • “The complete timeline for ICER’s Launch Price and Access report is available here.”
  • Fierce Pharma tells us,
    • “With three weeks of data on Lilly’s oral GLP-1 launch in obesity now on the books, the dimensions of Foundayo’s rollout—and its critical comparison to that of Novo Nordisk’s Wegovy pill—are coming into focus. 
    • “In its third week on the U.S. market, which ended April 24, Foundayo generated some 5,600 prescriptions, analysts at Jefferies wrote in a May 1 note to clients. That level of adoption is numerically lower than the stats recorded by the Wegovy pill in its third week, when prescriptions for the oral obesity med came in at around 26,100, per the note. 
    • “Nevertheless, almost all of Foundayo’s recorded performance stems from cash pay channels, according to the Jefferies team, with commercial access via insurance set to come online by the middle of this month, which will likely give Foundayo a substantial boost in uptake. 
    • “The team acknowledged that Foundayo’s reimbursement “appears to be ramping more slowly vs oral Wegovy’s.” 
    • “Overall, the analysts described Foundayo as “off to a solid start,” and estimate the drug will generate $146 million in the second quarter and $1.6 billion for all of 2026. That compares to consensus forecasts of $134 million and $1.2 billion, respectively.” 

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI, Uncategorized–

From the Iranian war front,

  • The Center for Strategic and International Studies offers an April 27, 2026, FAQ about “The Iranian Cyber Threat to U.S. Critical Infrastructure.”
  • MedTech Dive tells us,
    • “A cyberattack that shut down ordering, shipping and manufacturing at Stryker for weeks cut into the company’s first-quarter results.
    • “CEO Kevin Lobo told investors Thursday that the cyberattack “meaningfully” affected Stryker’s growth.
    • “The cyber incident had a big impact on our results and affected each of our businesses differently given their varied go-to-market models and processes to record revenue,” Lobo said. “This resulted in distortions in our first-quarter results that will normalize over the course of the year.” * * *
    • “Stryker was hit by the cyberattack on March 11. The company’s global Microsoft environment was disrupted, and ordering, shipping and manufacturing were shut down for weeks. Operations were not restored until the first week of April.
    • “The attack has been claimed by an Iran-linked threat actor tracked as Handala, according to Check Point Research. Along with the operational disruption, the group claims to have wiped thousands of servers and mobile devices, and stolen data.
    • “Lobo said the cyberattack wiped 40,000 laptops. He added that the company lost some procedures due to operations shutting down, and some sales reps were unable to get into hospitals. However, Lobo maintained that the company didn’t lose overall business.”
  • SC Media reports on April 27,
    • “Large medical devices maker Medtronic on April 24 said it was hit by a cyberattack that led to unauthorized access to data in some of its corporate IT systems. 
    • “However, in a statement, Medtronic said it had not identified any impact to its products, patient safety, or connections to its customers, manufacturing and distribution operations, financial reporting systems, or the company’s ability to meet patient needs.
    • “The networks that support our corporate IT systems, our products and our manufacturing and distribution operations are separate,” said the company. “Hospital customer networks remain separate from Medtronic IT networks and are secured and managed by customers’ IT teams.”
    • “The attack raised some eyebrows because it was reportedly claimed by Handala, the same group that was behind the attack on Stryker March 11 that led to service disruptions. This was the second publicly reported attack on a large medical device maker since the war with Iran started Feb. 28.”
    • “Handala didn’t target Medtronic by accident,” said Amir Khayat, co-founder and CEO of Vorlon. “Critical infrastructure, complex vendor networks, sensitive data, and known security gaps make healthcare one of the most attractive targets in the world. The teams that find out their exposure after an incident are the ones who never looked before it.”

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive reports,
    • “The U.S. government wants to know how major U.S. technology companies are using AI to protect their computer networks and how they’re preparing for the possibility of an AI-driven cybersecurity crisis.
    • “Officials from the White House’s Office of the National Cyber Director (ONCD) have reached out to tech giants in recent weeks with questions about AI, information sharing, vulnerability patching and how the federal government can help, according to an email and a list of questions shared with Cybersecurity Dive.” * * *
    • “ONCD asked the companies to answer 11 questions on a range of cybersecurity topics by May 1.”
  • √and
    • “A group of U.S. government agencies on Wednesday [April 29] offered advice for critical infrastructure organizations on applying zero-trust (ZT) principles to their operational technology (OT) environments.
    • “Taking a zero-trust approach to these industrial systems requires careful consideration, the new government publication says, “because OT systems interact with the physical environment and are constrained by availability and safety requirements, as well as legacy technology with long lifespans.”
    • “The document — co-authored by the Cybersecurity and Infrastructure Security Agency (CISA), the FBI and the departments of Defense, Energy and State — describes the unique challenges that OT environments pose, the importance of clear governance frameworks and supply-chain oversight, and the steps that infrastructure operators should take to implement zero trust.”
  • and
    • “The Australian and U.S. governments, along with other international partners, released guidance on Friday [May 1] for safely deploying agentic AI systems.
    • The automation capabilities of AI agents create unique risks that can lead to “productivity losses, service disruption, privacy breaches or cybersecurity incidents,” the guidance document reads. “Organisations must therefore anticipate what could go wrong, assess how agentic AI risk scenarios might affect operations and establish ongoing visibility and assurance to maintain confidence in their agentic AI investments.”
    • “Safely using AI agents means “never granting it broad or unrestricted access, especially to sensitive data or critical systems,” the document warns. Companies, it says, “should only use agentic AI for low-risk and non-sensitive tasks.”
    • “The publication — co-issued by the Australian Signals Directorate, the U.S.’s Cybersecurity and Infrastructure Security Agency and National Security Agency and their British, Canadian and New Zealand counterparts — comes as businesses race to integrate AI tools into their workflows and increasingly embrace agentic AI for its ability to automate repetitive tasks.”
  • HelpNet Security adds,
    • “AI agents need credentials to work. They authenticate with LLM platforms, connect to databases, call SaaS APIs, access cloud resources, and orchestrate across dozens of external services. Every integration point requires an identity. Most organizations are handling this badly, and the evidence is in the code.
    • “GitGuardian’s State of Secrets Sprawl Report found 28,649,024 new secrets exposed in public GitHub commits across 2025, a 34% year-over-year increase and the largest annual jump in the report’s history.
    • “One of the root causes is authentication design: which credential type gets chosen, what scope it carries, how long it lives, and where it gets stored. In the meantime, AI is creating more credentials that need managing and generating more artifacts where those credentials leak.”
  • Per a National Institute of Standards and Technology news release,
    • “The National Institute of Standards and Technology (NIST) is hosting a virtual event titled “Building Your Small Business Cybersecurity Team: From In-House to Outsourcing” on May 5, 2026, from 2:00 to 3:00 p.m. EDT. The webinar, part of National Small Business Week, focuses on helping small businesses develop cybersecurity teams to manage and reduce risks. It will address different team structures based on factors such as budget, staff capabilities, and organizational needs, including in-house roles, full teams, and outsourced support. Speakers will discuss considerations for hiring, outsourcing, and training employees, as well as available resources such as the National Initiative for Cybersecurity Education Workforce Framework for Cybersecurity.  For additional information and to register for the event refer to the official NIST Event page.”
  • Cyberscoop informs us,
    • “Two former cybersecurity professionals who moonlighted as cybercriminals, committing a series of ransomware attacks in 2023, were each sentenced to four years in prison, the Justice Department said Thursday [April 30].
    • “Ryan Clifford Goldberg and Kevin Tyler Martin previously pleaded guilty to one of three charges brought against them in December and faced up to 20 years behind bars. 
    • “Goldberg, who was a manager of incident response at Sygnia, and Martin, a ransomware negotiator at DigitalMint at the time, collaborated with Angelo John Martino III to attack victim computers and networks and use ALPHV, also known as BlackCat, ransomware to extort payments.
    • “These defendants exploited specialized cybersecurity knowledge not to protect victims, but to extort them,” Jason A. Reding Quiñones, U.S. attorney for the Southern District of Florida, said in a statement. “They used ransomware to lock down critical systems, steal sensitive data, and pressure American businesses into paying to regain access to their own information.”

From the cybersecurity breaches and vulnerabilities front,

  • The Washington Post reports on April 30,
    • “The Trump administration inadvertently exposed the Social Security numbers of health care providers in a database powering a new Medicare portal, The Washington Post found.
    • “The Centers for Medicare and Medicaid Services (CMS) last year created a directory to help seniors look up which doctors and medical providers accept which insurance plans, framing it as an overdue improvement and part of the Trump administration’s initiative to modernize health care technology.
    • “But a publicly accessible database used to populate the directory contains some of the providers’ Social Security numbers, linked to their names and other identifying information. For at least several weeks, CMS made the database available for public use as part of its data transparency efforts. The files are not immediately visible to users who visit the provider directory.
    • “The Post downloaded the database and identified at least dozens of Social Security numbers belonging to health care providers while reviewing a sample of rows.
    • “The Post informed health officials on Tuesday that the numbers had been exposed, giving the agency time to take down the database, and contacted some of the affected providers, who said they were confused and concerned.” * * *
    • “CMS officials said they are working to fix the problem that led to the exposure. A spokesperson said the problem “stems from incorrect entries of provider or provider-representative-supplied information in the wrong places” — essentially, that providers entered information in the wrong place and left their own Social Security numbers exposed.
    • “The agency has taken steps to address it promptly and reinforce safeguards around data submission and validation,” CMS said in a statement.”
  • Cyberscoop relates on April 30,
    • “A pair of persistent and problematic threat groups affiliated with The Com are actively targeting organizations across multiple critical infrastructure sectors for rapid data theft and extortion attacks, according to CrowdStrike.
    • “The financially-motivated attackers, which CrowdStrike tracks as Cordial Spider and Snarky Spider, have used voice-phishing and social engineering attacks to break into victims’ identity platforms and traverse SaaS environments since at least October 2025, the company said in a report Thursday, which it shared exclusively with CyberScoop prior to release. 
    • “Adam Meyers, senior vice president of counter adversary operations at CrowdStrike, said the subgroups composed of native English speakers primarily target U.S.-based organizations in the academic, aviation, retail, hospitality, automotive, financial services, legal and technology sectors.
    • “This “new wave of ecrime threat actors” are closely aligned with Scattered Spider and linked to other subsets of The Com, including SLSH and ShinyHunters, Meyers said.” 
  • Cybersecurity Dive tells us,
    • “Phishing attacks using QR codes to direct victims to malicious links surged in the first quarter of 2026, Microsoft said in a threat report published on Thursday [April 30].
    • “Email-based phishing attacks overwhelmingly used malicious links rather than attachments during the first three months of the year, reflecting the greater range of delivery options for externally hosted threats.
    • “A major phishing-as-a-service (PhaaS) platform is significantly diminished after recent attempts to choke off its infrastructure, the company said.”
  • InfoSecurity Magazine points out,
    • “The threat landscape in 2025 was characterized by a surge in compromised credentials, extortion and vulnerability exploitation, according to a new report from KELA.  
    • “The threat intelligence firm tracked nearly 2.9 billion compromised credentials last year globally, it said in its latest report, The State of Cybercrime 2026: Emerging Threats & Predictions.” * * *
    • “Cybercriminals and APT groups have moved from using AI merely as a supportive tool in attacks to making it an essential component in the complexity, enhancement, and escalation of those attacks,” it warned.
    • “Specifically, attacks have moved on from basic jailbreaking of LLMs to vibe hacking for autonomous execution of entire workflows, the report claimed. AI-assisted malware and prompt injection attacks designed to hijack agents are also increasingly common, KELA said.
    • “We’re seeing a fundamental pivot in adversary behavior with the shift from AI-assisted tools to fully autonomous, agentic malicious workflows, where over 80% of operations require minimal human oversight,” said David Carmiel, CEO of KELA.
    • “Attackers no longer need to break in through a backdoor, they can quickly find the key and walk through the front using stolen credentials. Organizations relying on stale intelligence and legacy defenses instead of AI-powered solutions are leaving the door wide open to attacks.”
  • The Cybersecurity and Infrastructure Security Agency, which beginning yesterday is no longer subject to shutdown, added four known exploited vulnerabilities to its catalog this week.

From the ransomware front,

  • Security Week reports,
    • “South Carolina-based healthcare provider Sandhills Medical Foundation has disclosed a data breach affecting nearly 170,000 individuals.
    • “Sandhills Medical said in a data security incident notice on its website that it discovered a ransomware attack on May 8, 2025. 
    • “It has since been working with law enforcement, cybersecurity experts, and a forensics firm to investigate the intrusion and determine its impact.
    • “Now, nearly one year later, the healthcare organization has publicly disclosed the incident and notified affected individuals.
  • Insurance Business Magazine relates
    • “A single ransomware crew exploiting a single brand of firewall is now driving nearly half of all cyber insurance claims, At-Bay has warned, in a finding that recasts how underwriters and brokers should be thinking about risk selection.
    • “The cyber carrier’s 2026 InsurSec Report, drawn from more than 6,500 claims and 100,000 policy years, concluded that ransomware has entered an infrastructure-driven phase.
    • “Attackers, it said, are no longer hunting by industry or company size but by the network appliances their targets happen to run.
    • “Nearly three in four ransomware attacks, or 73%, began with a VPN in 2025 — a share that has almost doubled in two years.
    • “SonicWall topped the list of most-targeted VPNs for the first time, linked to 27% of ransomware claims. Akira alone accounted for more than 40%, the highest concentration of a single strain on At-Bay’s books, with SonicWall appliances present in 86% of its attacks.”
  • Security Affairs tells us,
    • “Symantec researchers report that recent Trigona ransomware attacks used a custom-built data exfiltration tool instead of common utilities like Rclone or MegaSync. This shift, seen in March 2026 incidents, gives attackers more control and helps them evade detection, as standard tools are often flagged by security systems. Researchers believe this move shows a growing investment in proprietary malware to stay stealthy. 
    • “The attacks, which occurred in March 2026, mark a significant shift in tactics for Trigona affiliates. The motivation for moving away from publicly available tools remains unknown.” reads the report published by Symantec. “Many publicly available tools are now so well known that they may be flagged by security solutions.”
    • “Trigona, active since late 2022, operates as a Ransomware-as-a-Service linked to the Rhantus cybercrime group.”
  • Dark Reading informs us,
    • “The latest variant of an emerging ransomware may be far more destructive than its operators intended, acting as a wiper that deletes many of an organization’s captured files instead of encrypting them, as typical ransomware does. This scenario makes recovery impossible for defenders while complicating the possibility of holding files for ransom for the attackers.
    • “The Vect 2.0 variant of the ransomware-as-service (RaaS) operation, which first appeared last December, has a flaw across its versions for Windows, Linux, and VMware ESXi that inadvertently and permanently destroys so-called “large files” rather than encrypting them, according to a report published this week by Check Point Software. 
    • “For all files of only 128KB or higher, “this effectively makes Vect a wiper for virtually any file containing meaningful data, enterprise assets such as VM disks, databases, documents and backups included,” according to the report. Check Point has confirmed that the flaw, which “discards three of four decryption nonces for every file above 131,072 bytes (128 KB),” is identical across all three platform variants.” * * *
    • “For defenders, this makes the situation slightly worse, as they no longer will be able to recover all of their files, even if they agree to pay the ransom to do so, Check Point says. “Victims who pay the ransom cannot receive a working decryptor for their largest files, not through operator deception, but because the information required for decryption was irrecoverably destroyed at the moment of encryption.”
    • “They probably wouldn’t realize they can’t recover files only after the ransom is paid and their decryption key doesn’t work, which is why Check Point found it so important to report the flaw in Vect, Smadja says.”

From the cybersecurity business and defenses front,

  • CRN reports,
    • “Anthropic announced Thursday [April 30] it’s moving Claude Security, formerly known as Claude Code Security, into public beta to enable rapid AI-powered vulnerability discovery and remediation.
    • “The launch follows the widely discussed disclosure about Anthropic’s Claude Mythos Preview earlier this month, though the Claude Security offering does not leverage Mythos.
    • “Today’s models are already highly effective at finding flaws in software code,” Anthropic said in a blog post Thursday. “The next generation will be more capable still, and will be particularly effective at autonomously exploiting these flaws.”
  • Cybersecurity Dive relates,
    • “PwC has launched an AI-driven, unified detection-and-response managed security service, enabled by Google Security Operations.
    • “The recent announcement follows PwC’s three-year, $400 million collaboration investment with Google Cloud to modernize cybersecurity operations, unveiled in January. The offering targets smaller and mid-sized enterprises that wouldn’t typically turn to a big consulting firm for cybersecurity.
    • “This is not an old-school cyber-managed service offering that requires a lot of people, time and infrastructure to set up,” PwC’s Partner, Global and US Managed Services Leader, Tim Canonico told Channel Dive from the Google Cloud Next conference in Las Vegas. “We’re leveraging Google’s SecOps platform and building agents to do a lot of the work that would typically require large-scale teams to operate.” * * *
    • “All this automation has human checkpoints, and Canonico says it helps create an efficient, low-cost cybersecurity service with 24/7 monitoring, detection and response.”
  • Security Week tells us,
    • Cisco on Thursday [April 30] unveiled a new open source tool, named Model Provenance Kit, designed to help organizations address potential issues associated with the use of third-party AI models.
    • Organizations often leverage AI models obtained from model repositories such as HuggingFace, where millions of models are available.
    • While these models can offer many benefits, organizations often don’t track the changes made to them. In addition, although repositories provide guidance on the importance of model cards and metadata, the maintenance work performed by their developers can vary, affecting downstream users. 
  • The Wall Street Journal infoms us
    • “OpenAI and Microsoft MSFT have reached a truce.
    • “The startup and its longtime partner have forged a new deal that offers OpenAI more freedom to partner with Microsoft’s rivals, caps the amount of revenue it must share with the software giant through 2030 and removes a controversial clause in prior agreements. Microsoft, meanwhile, will retain access to the startup’s models and products.”
  • Here is a link to Dark Reading’s CISO Corner.

Tuesday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–
  • The Wall Street Journal reports,
    • “The Medicare agency will extend a short-term program that will pay for weight-loss drugs such as Eli Lilly’s Zepbound and Novo Nordisk’s NOVO.B -4.19%decrease; red down pointing triangle Wegovy, guaranteeing access to the popular medications will continue for seniors next year. 
    • “The decision by the Centers for Medicare and Medicaid Services comes after big Medicare insurers signaled that they didn’t initially plan to join a separate, longer-term payment model for the drugs that was supposed to launch at the start of 2027, throwing its future into question.
    • “Instead, the interim Medicare program, which starts in July and was expected to run only until the end of 2026, will continue until the end of 2027. Under this program, the government effectively pays for the medications, rather than adding them to Medicare insurers’ drug plans, which forces the insurers to account for the cost. 
    • “A CMS spokeswoman said the agency was extending the short-term program “after listening to stakeholder feedback.” The change will “allow data collection that will support a more effective potential implementation” of the longer-term model.
    • “The decision is good news for manufacturers such as Lilly and Novo Nordisk, which are counting on Medicare coverage to boost sales of their weight-loss drugs. Previously, Medicare Part D plans have been barred from covering weight-loss drugs, which means seniors who want to take them have had to pay several hundred dollars a month out of pocket.”
  • The House Appropriations Committee did not complete voting on the Financial Services and General Government (FSGG) bill today, having taken up and passed a Military Construction and Veterans Affair bill as the first order of business. The Committee will resume considering the FSGG bill tomorrow morning at 10 am ET.
  • The American Hospital Association News lets us know,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. April 21 testified in two hearings on the proposed fiscal year 2027 HHS budget, which requests $111.1 billion. In the morning, Kennedy testified before the Energy and Commerce Committee Health Subcommittee, and in the afternoon, he appeared before the Senate Appropriations Committee’s Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. He testified last week in a pair of meetings, one at the House Ways and Means Committee and another at the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.
    • ‘While the budget request is not binding, it serves as a preliminary framework for Congress and the administration as they determine federal funding levels and the scope of health care policy this year.”
  • STAT News relates
    • “The Trump administration will ask states to create new plans to verify medical providers paid by federally funded health care programs as part of a broad effort to combat fraud in government programs, Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, said Tuesday.
    • “The administration will ask states to develop plans in the next month to revalidate providers in “high-risk” areas to determine whether they exist and have the right to provide services, Oz said at Politico’s health care summit.
    • “The announcement is another step from the administration in its aggressive — and highly publicized — attacks on alleged waste, fraud, and abuse in federal health care programs. The administration has targeted certain programs and providers primarily in Democrat-led states such as Minnesota and California, though the administration’s claims have been disputed at times by state leaders. 
    • “We’re asking the states to own that problem,” Oz said.
    • “States that don’t take the effort seriously, he said, could become targets of closer federal scrutiny.”
  • The Government Accountability Office (GAO) adds,
    • “GAO has designated Medicare a high-risk program due, in part, to its complexity and potential for fraud. Fraud schemes in traditional Medicare often focus on certain services, such as durable medical equipment. Fraudsters may use stolen or inappropriately obtained Medicare beneficiary identifiers to submit fraudulent claims for unneeded or never provided services.
    • The Centers for Medicare & Medicaid Services (CMS), which oversees Medicare, uses data analytics on claims in traditional Medicare to identify anomalous patterns indicative of emerging fraud schemes and potentially fraudulent behaviors, such as billing spikes. CMS uses these analytics to develop leads for investigations and to inform administrative actions that can prevent potentially fraudulent payments, such as suspending provider payments. For example, in 2023 and 2024, CMS suspended payments to, and later revoked the enrollment of, 15 providers involved in a scheme that allegedly billed Medicare for more than $4 billion in urinary catheters that were never supplied. Selected private payers GAO spoke with reported using data analytics in ways similar to CMS—namely, to identify anomalous provider billing patterns to generate leads for investigations and to inform actions like payment suspensions.
    • CMS estimates that from fiscal years 2022 through 2024, it prevented a total of $11.9 billion in potentially fraudulent Medicare payments by taking administrative actions on providers engaged in potential fraud.
    • Here is a link to the GAO report.
  • The American Journal of Managed Care tells us
    • “Cancers with the highest lethality receive disproportionately lower levels of federal research support, according to a research letter published today in JAMA Network Open.
    • “Outcome-weighted metrics (mortality, 5-year survival, MIR) better capture unmet need than incidence alone when assessing cancer burden and urgency. 
    • “Lung cancers accounted for 151,401 deaths, exceeding pancreatic (49,211), breast (22,606), and prostate (5,219) among the cancers evaluated. 
    • “Mortality-to-incidence ratios highlighted extreme lethality in SCLC and pancreatic cancer (>0.85), while breast and prostate cancers showed low ratios (<0.10) consistent with higher survivorship. 
    • “Funding per estimated death was markedly higher for breast ($69,800) and prostate ($126,992) than pancreatic ($8,945) and SCLC ($2,818), supporting a composite allocation framework.”

From the Food and Drug Administration front,

  • Radiology Business informs us,
    • “Conavi Medical, a Toronto based medtech company, received U.S. Food and Drug Administration (FDA) clearance for a next-generation hybrid imaging system capable of performing intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at the same time. 
    • “Conavi has carved out its own space in the field of intravascular imaging by developing hybrid systems that save cath labs valuable space by performing two different exams of a patient’s coronary anatomy at once. The company’s original Novasight Hybrid System gained FDA clearance in 2018.” * * *
    • “Conavi hopes to start commercializing this next-generation technology and initiate a limited market release in the second half of 2026.”

From the judicial front,

  • STAT News reports,
    • “A judge is expected to sentence OxyContin maker Purdue Pharma to forfeit $225 million to the Justice Department on Tuesday, clearing the way for the company to finalize a settlement of thousands of lawsuits it faces over its role in the opioid crisis.
    • “The penalty was agreed to in a 2020 pact to resolve federal civil and criminal probes it was facing. If the judge signs off, other penalties will not be collected in return for Purdue settling the other lawsuits.
    • “After years of legal twists and turns, the settlement was approved by another judge last year and could take effect May 1. It requires members of the Sackler family who own the company to pay up to $7 billion to state, local and Native American tribal governments, some individual victims and others.”

From the public health and medical research front,

  • MedPage Today reports,
    • “A mobile health intervention helped pregnant patients with overweight or obesity reduce gestational weight gain (GWG), a cluster-randomized trial showed.
    • “The weekly rate of GWG was significantly lower in the intervention group versus the standard care group (mean 0.25 vs 0.28 kg/week; mean between-group difference -0.03, 95% CI -0.05 to -0.01), reported Monique M. Hedderson, PhD, of Kaiser Permanente Northern California in Pleasanton, and colleagues.
    • “Total GWG was also significantly lower in the intervention group, at a mean of 9.7 kg compared with 10.6 kg in the standard care group (mean between-group difference -0.87, 95% CI -1.40 to -0.34), they wrote in JAMA Network Open.” * * *
    • “The Lifestyle, Eating, and Activity in Pregnancy (LEAP) intervention utilizes a smartphone app, wireless scale, and activity tracker to promote healthy eating and increased activity. As a stepped intervention, more intensity is reserved for those on track to gain more weight. All participants are given a personalized calorie target and weekly education topics, and are encouraged to track weight, activity, and diet. Step two adds two weekly personalized chat messages with a lifestyle coach/registered dietitian and step three adds biweekly telephone sessions.
    • “LEAP shows “that combining clinician engagement with patient‑facing digital tools can improve gestational weight outcomes in real‑world care settings,” Hedderson said.”
  • Medscape points out,
    • “The American College of Physicians (ACP) has updated its guidance on screening for breast cancer in asymptomatic average-risk women using recent high-quality clinical recommendations from guideline developers from expert societies around the world.
    • “Publishing in the Annals of Internal Medicine, panelists led by Amir Qaseem, MD, PhD, MHA, the ACP’s chief scientific officer and senior vice president of clinical policy, made five recommendations, taking into account age group and breast density category.
    • “This updated guidance statement is based on new data and new or updated guidelines evaluated by the ACP since the publication of our 2019 guidance statement, which is over 7 years old,” Qaseem told Medscape Medical News.”
  • The American Medical Association lets us know what doctors wish their patient knew about appendicitis.
    • “There’s a pain in your abdomen. Is it something as simple as gas or is it appendicitis? Four physicians share what to keep in mind about appendicitis.”
  • Health Day informs us,
    • “The overdose-reversing drug naloxonehas been rightly hailed as a lifesaving breakthrough, saving countless lives from opioid ODs.
    • “But a new study warns that the wonder drug has its limits, especially when confronted with overdoses involving the powerful new wave of synthetic opioids like fentanyl.
    • “Naloxone may not fully reverse ODs caused by synthetic opioids, researchers report in the May issue of the journal Anesthesiology.
    • “As a result, bystanders should be ready to give additional doses of naloxone if the first doesn’t restore an overdose victim’s breathing, researchers said.”
  • Genetic Engineering and Biotechnology News relates,
    • “Researchers from Kindai University in Japan have developed a machine learning model that accurately predicts the origin of diverse cancer types in patients with cancers of unknown primary (CUP) by analyzing CpG-based DNA methylation. Results showed that the model correctly identified the cancer type in about 95% of cases in the test cohort and achieved 87% accuracy when applied to an independent validation cohort from 31 cases representing 17 different cancer types. The work was presented at the American Association for Cancer Research (AACR) Annual Meeting.  
    • “Our findings suggest that DNA-based approaches can help identify where a cancer may have started, even when the original tumor is not visible,” said Marco A. De Velasco, PhD, a faculty member in the department of genome biology at Kindai University in Japan.”  
  • STAT News notes,
    • “BioAge Labs said Tuesday that its investigational pill for cardiovascular risk prevention significantly reduced inflammation in an early study, as more drug companies target inflammation as a way to treat a range of chronic conditions.
    • “In a Phase 1 study of people with obesity and elevated inflammation levels, patients taking a 60-milligram dose of the drug, called BGE-102, experienced an 85% reduction in a measure of inflammation called high-sensitivity C-reactive protein (hs-CRP) after one week, and the reduction was maintained three weeks out. That’s a similar effect seen in patients who took a higher 120-mg dose in the study, which the company previously reported.”
    • “Additionally, 87% of patients taking the 60-mg dose achieved hs-CRP levels of less than 2 mg/liter, the threshold thought to be associated with a lower risk of cardiovascular complications.
    • “High cholesterol and blood pressure have long been known contributors to heart disease, but researchers more recently identified inflammation as a risk factor as well. Companies like BioAge are betting that drugs that can effectively reduce inflammation could one day be as widely used as statins.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • :UnitedHealth Group UNH reported first-quarter results that substantially overshot Wall Street expectations and raised its annual guidance, signaling progress in its financial turnaround.
    • The announcement is likely to build investor confidence in the healthcare company’s current direction, a year after UnitedHealth announced an earnings shortfall that touched off an unprecedented share meltdown for the company.
    • “Former Chief Executive Stephen Hemsley returned to the top job last May, saying the company needed a reset. He has focused on retrenching and bolstering margins.” * * * 
    • “UnitedHealth highlighted changes made under Hemsley’s tenure, including replacing almost half the company’s top 100 executives and making substantial artificial-intelligence investments. UnitedHealth said it had struck a deal to take over Alegeus Technologies, a benefits-administration company, without disclosing the financial terms.”  
  • BioPharma Dive relates,
    • “Flagship Pioneering has launched a new biotechnology firm that believes it’s found a way to solve the problems that have long held back genetic medicine. 
    • “Called Serif Biomedicines, the startup officially debuted on Tuesday armed with $50 million in funding and the ability to make what it refers to as “modified DNA” medicines.
    • “According to CEO and co-founder Jacob Rubens, Serif’s drugs are designed to combine the strengths of multiple types of genetic medicines, from gene therapy to the messenger RNA and small-interfering RNA approaches popularized by companies like Moderna and Alnylam Pharmaceuticals. Its treatments consist of two components: finely tuned instructions for a therapeutic protein as well as an mRNA sequence for “co-factors” that can help the treatment get into a cell’s nucleus. They’re sent to cells with the help of fatty shells called lipid nanoparticles, which are commonly used to deliver complex medicines.”
  • Adam Fein writes in his Drug Channels blog,
    • “Drug Channels Institute’s (DCI’s) latest analysis reveals that PBM-affiliated specialty pharmacies continue to dominate the dispensing of specialty drugs. 
    • “For 2025, DCI has identified more than 1,900 dispensing locations with specialty pharmacy accreditation from one or both of the two major independent accreditation organizations. The overall number of accredited locations grew by only 3% in 2025, but is more than five times larger than the 2015 figure.
    • “However, market share for the dispensing of specialty drugs remains highly concentrated. For 2025, the three largest specialty pharmacies accounted for two-thirds of total prescription revenues from pharmacy-dispensed specialty drugs. These businesses are all owned by vertically integrated organizations that also own a PBM.”
  • Beckers Hospital Review informs us,
    • “More Wegovy prescriptions are being written as GLP-1 weight loss drugs gain traction across retail, telehealth and direct-to-consumer channels, according to an April 20 report from Truveta Research.
    • “The growth follows the FDA’s December approval of oral Wegovy (semaglutide) and other GLP-1 pills. Diverging commercialization strategies from manufacturers are also reshaping how patients access these therapies and how health systems approach formularies and metabolic care programs.”

Thursday report

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

From Washington, DC

  • Roll Call reports,
    • “Senate Republicans plan to release a budget resolution next week that would kick-start the process for a reconciliation bill on immigration enforcement funding and help end a partial shutdown of the Department of Homeland Security, lawmakers said Thursday.
    • “The party is aiming to provide about $70 billion in funding for Immigration and Customs Enforcement and the Border Patrol to sustain them for at least the next three years, without placing any new guardrails on federal immigration agents sought by Democrats. The budget resolution would contain instructions to the Homeland Security and Governmental Affairs and Judiciary panels, which would be charged with writing the details of the upcoming reconciliation bill.
    • “Senate Majority Leader John Thune, R-S.D., said Thursday that the chamber is “hoping to get on a budget resolution by middle to end of next week.”
  • The American Hospital Association News relates,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. April 16 testified during two House hearings on the HHS fiscal year 2027 budget proposal, which requests $111.1 billion. He first appeared in a morning session held by the House Ways and Means Committee. In the afternoon, he testified during a hearing held by the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. Kennedy will appear in additional House and Senate hearings next week to testify on the budget proposal. 
    • “While the budget request is not binding, it serves as a preliminary framework for Congress and the administration as they determine federal funding levels and the scope of health care policy this year.”
  • The New York Times tells us,
    • “In a sharp break with his past rhetoric, Health Secretary Robert F. Kennedy Jr. offered a qualified embrace of the measles vaccine on Thursday, as President Trump named a new director of the Centers for Disease Control and Prevention whose views on vaccination are more conventional than Mr. Kennedy’s.
    • “In back-to-back hearings on Capitol Hill, Mr. Kennedy testified that the measles vaccine is safe and effective “for most people” and agreed it was safer than getting measles. Under questioning, he also allowed that the vaccine might have saved the lives of two unvaccinated children who died of measles in Texas earlier this year.
    • “His comments, while carefully couched, stand in stark contrast to his previous statements about vaccination. Coupled with Mr. Trump’s announcement of Dr. Erica Schwartz, a deputy surgeon general in his first administration, as his new pick for C.D.C. director, they provided the latest evidence yet that Mr. Kennedy is trying to publicly put his efforts to overhaul American vaccine policy behind him.”
  • The Washington Post adds,
    • “Kennedy highlighted efforts to phase out synthetic food dyes, overhaul dietary guidelines and strike deals with pharmaceutical companies. He said he planned to overhaul an influential task force focused on preventive screening recommendations. And he often appealed to his Make America Healthy Again base that doesn’t always fit within the Republican agenda, including saying he had “grave reservations” about a White House executive order boosting a commonly used weedkiller.
    • “Our children are the sickest generation in modern history — and decades of failed policy, captured agencies and profit-driven systems have caused it,” Kennedy said at Thursday morning’s hearing before the House Ways and Means Committee. “Parents across this country demanded change — and we are delivering it.”
  • The Wall Street Journal informs us,
    • ‘President Trump said Thursday he will nominate Dr. Erica Schwartz to direct the Centers for Disease Control and Prevention.
    • “The CDC has been without a permanent director since Susan Monarez wasousted last year after clashing with Health Secretary Robert F. Kennedy Jr.over vaccine policy.
    • “Schwartz served as deputy surgeon general, a nonpolitical role, in the first Trump administration. She has a medical degree from Brown University, as well as a master’s degree in public health and a law degree.” * * *
    • “Trump said he was also appointing three others to a team to help lead the CDC, including health executive Sean Slovenski; Commissioner of the Texas Department of State Health Services Dr. Jennifer Shuford; and Food and Drug Administration Principal Deputy Commissioner Dr. Sara Brenner.
    • “Kennedy voiced his support for the new team earlier Thursday in a hearing before a House subcommittee.”
  • The AHA News points out,
    • “The Centers for Medicare & Medicaid Services has released an updated request for applications for the Long-term Enhanced ACO Design Model, or LEAD. Applications are due May 17. The agency also announced that it will host an office hour April 21 at 1 p.m. ET for prospective applicants. CMS said it will address FAQs about eligibility, participation requirements, financial methodology, quality measures, and the application process and timeline. Participants can also submit questions in advance.”
  • Tammy Flanagan, writing in Govexec, discusses “when retirement calculations don’t move on the same timeline.”
    • “Retroactive pay changes and delayed annuity adjustments underscore how federal retirement processing often depends on timing, coordination, and most importantly, patience.”
  • Per an OPM news release,
    • “In a coordinated effort led by First Lady Melania Trump and the Administration for Children and Families (ACF), the Office of Personnel Management (OPM) today announced new actions to expand workplace flexibilities and support for foster and adoptive families across the federal workforce. 
    • “The initiative builds on Executive Order 14359, “Fostering the Future for American Children and Families,” and reflects a broader administration priority to help more children grow up in safe, stable, and loving homes.
    • “To advance these efforts, OPM is directing agencies to highlight key provisions in its Handbook on Leave and Workplace Flexibilities for Childbirth, Adoption, and Foster Care. Federal agencies are being mobilized to better connect employees with a wide range of workplace flexibility and benefits available when fostering or adopting a child. These include up to 12 weeks of paid parental leave, leave under the Family and Medical Leave Act, flexible work schedules, and other tools designed to help working families navigate major life transitions.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Eli Lilly’s new obesity pill Foundayo met the main goal of a heart safety trial in people with diabetes, putting people who take it at no greater risk of heart attacks and other cardiovascular events than people who received long-acting insulin, the company said Thursday.
    • “The Indianapolis-based drugmaker also said people who got Foundayo were at no greater risk of liver harm than those who got insulin, fulfilling a post-marketing requirement of the pill’s Food and Drug Administration approval for obesity. The trial additionally hinted that the pill might reduce the risk of death from any cause, although that finding would need to be confirmed in additional testing.
    • “Lilly said it will seek an approval for Foundayo in diabetes by the end of the second quarter and utilize a national priority review voucher that could lead to a speedy clearance. A regulatory OK in diabetes would open up a new front in a commercial war with Novo Nordisk, which has marketed a diabetes pill called Rybelsus since 2017.”
  • Cardiovascular Business relates,
    • “AOP Health, an Austrian pharmaceutical company, has secured U.S. Food and Drug Administration (FDA) approval for landiolol to be used for the treatment of supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter, in pediatric patients.
    • “Landiolol, sold under the brand name Rapiblyk, is an adrenergic receptor blocker that acts fast. It is only meant be administered as an intravenous infusion in a hospital setting. 
    • “In 2024, the drug was approved for adults after the FDA reviewed data from multiple randomized trials. This update to cover patients of all ages was based on the LANDI-PED study, which included 60 pediatric patients presenting with SVT. Overall, treatment with landiolol was linked to a reduction in ventricular rate of more than 20%.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement therapy (TRT) products to contact FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism (without a known cause).
    • “New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We are eager to work with sponsors to further evaluate this potential new use while upholding our rigorous standards for safety and effectiveness.” 

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Rotavirus, a seasonal virus similar to influenza, has been rising across the U.S. since January. With infection rates higher now than this time last year, doctors have fresh concerns that declining vaccinations could lead to more severe illness and a higher surge in the coming years. 
    • “The virus — which is spread by hands touching an infected surface, then touching the mouth — used to be a major cause of severe illness among babies and young children in the U.S., responsible for more than 200,000 emergency room visits, up to 70,000 hospitalizations and dozens of deaths each year, according to the National Foundation for Infectious Diseases. That drastically changed after the first oral vaccine was approved 20 years ago.
    • “Data from WastewaterScan, an academic program through Stanford University in partnership with Emory University, shows the virus has been surging since January, with levels continuing to increase in certain parts of the U.S., including the West and the Midwest. * * *
    • “We’re seeing a lot of rotavirus in wastewater right now, definitely very high levels and that indicates to us that there are high levels of rotavirus infections in these communities,” said Dr. Marlene Wolfe, WastewaterScan’s program director and co-principal investigator.”
    • The Centers for Disease Control and Prevention estimates that 40,000 to 50,000 hospitalizations among infants and young children are prevented every year due to the vaccines, which are given starting at 2 months of age. 
    • “Despite the data, earlier this year, Health and Human Services Secretary Robert F. Kennedy Jr. announced changes to the childhood immunization schedule, which included removing the rotavirus vaccine and telling parents they should talk to their doctor before deciding to vaccinate. 
    • “The virus is still circulating,” Offit said. “So a choice not to get a vaccine is a very real choice to experience that infection.” While the schedule changes were put on hold by a federal judge last month, doctors worry that even attempted moves to change the guidelines likely planted seeds of doubt among some new parents, who may now hesitate to vaccinate for rotavirus.”
  • MedPage Today adds,
    • “Despite tetanus being preventable with vaccination, cases continue to occur in the U.S., with deaths mostly affecting older adults, the CDC reported.
    • “From 2009 through 2023, there were 402 tetanus cases reported to the CDC in 47 states and the District of Columbia, with 16 states reporting 37 tetanus-associated deaths, wrote Michelle Hughes, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in Morbidity and Mortality Weekly Report Surveillance Summaries.”
  • Beckers Hospital Review relates,
    • “New York City-based NYU Langone Health researchers found that nearly 7% of trauma admissions are associated with pedal-powered and electronic bikes or scooters.
    • “The study, published April 15 in Neurosurgery, analyzed 914 patients treated over five years at a New York City-based Bellevue Hospital Center. Researchers found that the share of trauma cases involving an electric mobility device grew from under 10% in 2018 to more than half in 2023.”
  • The New York Times tells us,
    • “Since the approval of new Alzheimer’s drugs in recent years, there has been a lingering question: While data indicated that they could modestly slow cognitive decline for some patients, would that effect be meaningful or too slight to make difference?
    • “A new review of research spanning a decade, published on Wednesday, concluded that the clinical benefit of these and similar drugs is negligible. But the way the review was conducted spurred heated criticism from many Alzheimer’s experts, including some who had been skeptical of some of them.”
  • STAT News points out,
    • “The scientists whose work spurred the development of powerful obesity drugs like Eli Lilly’s Zepbound are now raising a provocative hypothesis: Perhaps targeting the GLP-1 hormone is actually not necessary to achieve effective weight loss.
    • “A group of researchers led by Richard DiMarchi and Matthias Tschöp has created an experimental drug that activates receptors of the GIP and glucagon hormones. They propose — based on rodent and monkey studies — that this kind of molecule, when administered at high enough doses, may result in weight loss comparable to the weight loss seen with drugs that include GLP-1 as a target, and without the tolerability issues like nausea and vomiting that often come with the approved treatments, according to a peer-reviewed draft paper published this week.
    • “The research, funded by a biotech called BlueWater Biosciences, would still need to be confirmed in humans; oftentimes results seen in animals don’t translate in the clinic. But the proposed approach, outlined in the journal Molecular Metabolism by some of the most well-known scientists in the field, is likely to stir controversy, as it challenges a central notion underpinning not just the development of approved obesity products but also next-generation versions.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “The University of Southern California (USC) research team that identified the hormone-encoding gene GDF15 as a key driver of pregnancy sickness has identified nine additional genes linked to its most severe form, hyperemesis gravidarum (HG). Six of the identified genes had not been previously linked to the condition.
    • “The Keck School of Medicine of USC team and international collaborators conducted a genome-wide association study (GWAS), scanning the entire genome for differences between women who developed HG during pregnancy and those who did not. They analyzed data from more than 10,000 women with the condition and more than 450,000 controls across European, Asian, African, and Latino ancestries. Their findings offer new clues about the condition and new hope for those affected.
    • “Marlena Fejzo, PhD, a clinical assistant professor of population and public health sciences in the Center for Genetic Epidemiology at the Keck School of Medicine, led the present study and earlier research linking GDF15 to HG. Fejzo told GEN, “The study is much larger than previous studies and on a more diverse population allowing for identification of new genes associated with HG … The new genes give us new directions to explore for prediction, diagnosis, treatment, and response to therapies.”
  • and
    • “In a new study published in Nature titled, “Mapping convergent regulators of melanoma drug resistance by PerturbFate,” researchers from The Rockefeller University have developed a platform called PerturbFate that can systematically map how diverse disease-associated genetic variations reshape cells. By tracking gene regulation in single cells over time, the team identified regulatory nodes common to diverse variations. Using melanoma drug resistance as a proof-of-concept, results showed that these shared points of control offer a path toward combination therapies that can target disease across many genetic causes.”

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

  • Cardiovascular Business reports,
    • “XCath Robotics, a Houston-based medical robotics company, announced the successful completion of the world’s first telerobotic stroke operation of its kind. Neurosurgeon Vitor Mendes Pereira, MD, chair of advanced neurovascular interventions at the University of Toronto, used the XCath Iris Surgical Robotic System to perform the historic procedure. While Pereira was in Santiago, Panama, the patient was approximately 120 miles away in Panama City.”
  • On a related note McKinsey & Co. interviews “Sam Hazen, CEO of HCA Healthcare, [who] reflects on the state of the industry and how emerging technologies and steadfast leadership can help meet patients where they are.”
  • Healthcare Dive relates,
    • “Walmart is expanding its digital health platform to include weight management services as the retail health giant looks to capitalize on consumer interest in GLP-1 weight loss drugs.
    • “The retailer’s digital health platform, called Better Care Services, can now connect patients to third-party weight management offerings from companies like Aaptiv and Curai Health. The providers can prescribe GLP-1s, while Walmart will handle prescription fulfillment, according to a Thursday press release.
    • “Walmart said the expansion should bridge the retailer’s pharmacy and digital health services, creating easier access to GLP-1s during a time of surging demand for the weight loss medications.”
  • Fierce Healthcare adds,
    • “More pharma companies are launching direct-to-consumer drug platforms and the rise of these self-pay services could improve access to medicines but also raise concerns about oversight and accountability.
    • “The Digital Medicine Society is leading a cross-sector effort, in partnership with pharma companies, virtual-first providers and digital pharmacies, to establish a scalable blueprint for direct-to-patient pharma models as the market continues to evolve.
    • “As Big Pharmas increasingly roll out platforms for direct-to-consumer drug sales, most offering steep discounts on popular medications, many patients are open to using the new services, Fierce Pharma Marketing reported. Three-quarters of U.S. consumers are “somewhat” or “very” likely to use DTC drug sale services, a survey found.” * * *
    • “The new initiative currently involves four leading pharma companies, with plans to add more. Founding partner companies involved in the initiative include Coalesce Health, DistributeRx, Fullspan Health, Health Advances, Phil, Inc., S3 Connected Health, Welldoc, Wheel and Ypsomed.”
  • and
    • “The American Psychological Association (APA)’s Labs division announced Tuesday the launch of a digital health resource guide for those seeking out mental health tools.
    • “The APA Labs Digital Badge Solutions Library is a searchable collection of resources and technologies that have earned the organization’s Digital Badge. Users can browse tools and applications related to behavioral health and wellness; clinical tools; family, pediatrics and monitoring and sleep, relaxation and mindfulness. 
    • “The library launched with “an initial cohort of early adopters” to meet independent evaluation demand, the announcement said. Six tools are currently in the library “with many more products in the evaluation pipeline,” APA Labs Managing Director Tanya Carlson told Fierce Healthcare in an emailed statement.”
  • Trilliant Health has posted its “2026 Behavioral Health Report.”
    • “An analysis of demand, supply and yield for behavioral health finds that the crisis has intensified in the years following the COVID-19 pandemic.”
  • AP lets us know,
    • ” A West Health–Gallup Center on Healthcare in America poll published Wednesday, conducted in late 2025 and backed up by at least three other recent surveys with similar findings, found that roughly one-quarter of U.S. adults had used an AI tool for health information or advice in the past 30 days.
    • “Dr. Karandeep Singh, chief health AI officer at the University of California San Diego Health, said AI tools, many of which now incorporate web search, are an upgraded version of Google health searches that Americans have been doing for decades.
    • “I almost view it like a better entry portal into web search,” he said. “Instead of someone having to comb through the top, you know, 10, 20, 30 links in a web search, they can now have an executive summary.”
  • Healthcare Dive adds,
    • “Abridge is expanding its clinical decision support tool through two partnerships with publishers of major medical journals, the AI scribe company announced Wednesday. 
    • “Under the deal, content from the New England Journal of Medicine and the JAMA Network will inform the AI’s responses when clinicians search for medical information and ask questions about patient care.
    • “The tool should allow clinicians to more easily access the latest medical research, Abridge said. “With the amount of complexity that exists in healthcare now, easy access to information for the right patient, the right moment, the right clinical conversation — it’s critical,” Matt Troup, clinical strategy principal at Abridge, said in an interview.”
  • Cardiovascular News notes,
    • “Stereotaxis, a St. Louis-based medtech company, has agreed to acquire Robocath, a major player in the field of robotic interventional cardiology technologies. 
    • “The deal includes an upfront payment of $20 million. Stereotaxis could pay up to an additional $25 million if certain regulatory and commercial milestones are met.
    • “Stereotaxis already specializes in robotic technologies used for a variety of minimally invasive endovascular procedures. Scooping up Robocath helps the company expand its offerings to include devices used for percutaneous coronary intervention (PCI) and other critical operations performed by interventional cardiologists in the cath lab. 
    • “Robocath is based in Rouen, France. The company’s flagship technology is the R-One+ system, a robotic system that helps cardiologists perform PCI, and work on a next-generation version of the R-One+ is already underway. Stereotaxis aims to ramp up work on that new technology once its acquisition is complete.” 

Weekend Update

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

From Washington, DC

  • Per a Senate news release,
    • “The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing Thursday [April 16 at 10 AM] on how Congress can lower the cost of prescription drugs for American families by increasing competition among generic and biosimilar manufacturers. U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the HELP Committee, is spearheading President Trump’s mission to make health care affordable.”
  • Hopefully, Congress will resolve the Department of Homeland Security shutdown this week. Federal News Network adds,
    • “Homeland Security Secretary Markwayne Mullin is recalling all furloughed Department of Homeland Security staff to report to their next scheduled shift, despite the ongoing partial government shutdown.
    • “In an official message sent to DHS employees late Friday afternoon, staff were told that “all DHS employees, excepted and non-excepted/non-exempt” are to be returned “to a work and paid status, effective on your next regularly scheduled duty day.”
  • Here’s a link to Roll Call’s projected activities on Capitol Hill this week.

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • About one in five males older than 15 years is infected with a high-risk HPV type.
    • Among males ages 9 to 26 years, those who received the 9-valent HPV vaccine had a lower risk of a composite of HPV-related cancers compared with those who were unvaccinated.
    • These results indicate that HPV vaccination should be sex-neutral, researchers said.
  • The New York Times asks whether you are confused about the new cholesterol guidelines? If so, here’s what to hnow.
    • “New recommendations suggest that some people should start trying to lower their cholesterol as early as age 30.”
  • and
    • lets us know about “D.W.I.s, relationship problems, accusations of secret drinking: Auto-brewery syndrome can wreak havoc on people’s lives and reputations.”
      • “The Mystifying Syndrome That Makes People Spontaneously Drunk.”
  • NPR Shots informs us
    • “Forty percent of Americans have their daily lives interrupted by uncomfortable bowel symptoms, according to the American Gastroenterological Association. That’s a lot of troubled guts.
    • “But Dr. Trisha Pasricha says at the other end of the spectrum, there are people who experience “poophoria.” That’s Pasricha’s term for a state of being where doing your business is painless and worry-free. “ I just want you to poop quickly, effortlessly, and then go live your best life,” she says.”
    • The article provides the Doctor’s advice.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The Affordable Care Act of 2010’s medical loss ratio provision, which requires insurers to spend 80-85% of premium dollars on medical care, likely accelerated revenue diversification through venture capital arms, said Rachel Sachs, a law professor and co-director at The Cordell Institute at Washington University School of Law. Insurers are incentivized to find other profit generators that are not capped by federal legislation.
    • “Acquiring a stake in a company can lead to long-term financial gain if they exit their position or acquire the business. Cigna, for example, purchased telehealth provider MDLive in 2021 after Cigna Ventures invested in its Series E round in 2018.
    • “An insurer also may see value in the emerging company’s product and encourage the parent company to deploy it.” * * *
  • Fierce Pharma relates,
    • “Novartis is launching a three-front push to close healthcare gaps in heart disease and cancer, expanding initiatives to roughly triple its footprint by 2030. 
    • “The three initiatives include the new Inclusive Health Accelerators (IHA) program. Launched in five U.S. cities this week, IHAs are designed to support early detection of prostate and breast cancer and address care gaps in underserved populations. Novartis will use the community-driven IHA model to support access to education, free screenings, diagnosis and follow‑up care.
    • ‘Basel-based Novartis will collaborate with local groups in New York, Los Angeles, Detroit, Houston and Baltimore to deliver the services. The initiative builds on existing U.S. partnerships, such as the Health Assessments and Rapid Transformation program that Novartis launched last year.”
  • and
    • “As geopolitics bring reshoring interest to a fever pitch, the United States Pharmacopeia (USP) is adding to the impetus for local drug production with a warning that homes in on the pharmaceutical building blocks known as key starting materials. 
    • “In its new supply chain vulnerabilities update (PDF), USP, a nonprofit that helps set quality standards for medicines, highlighted 100 acute and chronic medications that, while not necessarily all in current shortage, are at risk of supply gaps and other disruptions. This is due to bottlenecks in their production chains, especially in the upstream phase focused on activities like sourcing raw materials, according to USP. 
    • “Looking at the broad trends, some 30% of the drugs on USP’s updated list are currently in shortage, per the U.S. FDA. Many of the therapeutics that have made it into the lineup are deemed essential by the World Health Organization or FDA, including multiple hospital drugs, chemotherapies, steroids and anesthetics, as well as drugs for chronic conditions like ADHD, diabetes and cardiac diseases, among many others.
    • “Notably, 63% of the medicines identified for their supply chain vulnerabilities are injectables, which USP chalked up to the “inherent manufacturing complexity” of that dosage form. Oral solid meds like tablets and capsules represented the second-biggest group of vulnerable drugs, making up 22% of the list, according to USP. 
    • “In perhaps the biggest flag from the updated list, USP noted that nearly half (48%) of the drugs included have at least one of their key starting materials (KSMs) solely manufactured in one country, which the organization deemed a “potential point of failure.” 
  • BioPharma Dive informs us,
    • “Chinese biotechnology company Oricell Therapeutics said Friday it banked more than $110 million in a “pre-IPO” venture funding that will help it advance a portfolio of cell therapies for tough-to-treat solid tumors. 
    • “Oricell’s lead program is being tested against advanced hepatocellular carcinoma, an aggressive liver cancer that most frequently occurs in people with chronic organ damage. That therapy, Ori-C101, has already completed early testing in humans and demonstrated what the company claims to be a “best-in-class efficacy and safety profile.” 
  • The Wall Street Journal adds,
    • “Finding innovative ways to treat cancer is Pfizer’s biggest priority so to boost cutting-edge technologies, Pfizer executives went to Shenyang, China. There, last summer, Pfizer paid $1.25 billion to China’s 3SBio for rights to a cancer drug candidate.
    • “Not long ago, China was a backwater for drug research. Its companies made pharmaceutical ingredients or lower-cost generic drugs. Its patients offered an opportunity for big drugmakers to sell medicines developed in the West. 
    • “Now it’s a major player in biotechnology. Researchers and startups in China are racing to develop hot new medicines for cancer, weight-loss and other diseases. Many are on the cutting edge of molecular biology. 
    • “China is rallying their innovation to degrees that we haven’t seen before,” Pfizer Chief Executive Albert Bourla said. 
    • “Looking to tap in to the innovation, big drugmakers and investors are spending billions to lock up rights to promising Chinese-originated drug candidates like 3SBio’s.”

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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