Midweek update

Medical / Rx research

Midweek update

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The White House May 4 released its National Drug Control Strategy, which, among other efforts, recommends effective primary prevention programs. The initiative increases the implementation of evidence-based prevention strategies; establishes new partnerships with organizations supporting youth health and expanding primary prevention; supports a national media and education campaign against drug use; and supports and enhances the federal drug-free workplace program.”
  • The Centers for Medicare and Medicaid Services announced,
    • “The Centers for Medicare & Medicaid Services (CMS) will provide eligible Medicare beneficiaries access to certain GLP-1 medications for $50 per month beginning July 1, 2026, through December 31, 2027.
    • “Under the Medicare GLP-1 Bridge, a time-limited demonstration, CMS is expanding access to innovative, evidence-based weight-loss treatments. Eligible individuals enrolled in Medicare Part D prescription drug plans will be able to access these medications at a predictable and affordable cost—$50 for a monthly supply. This approach reflects CMS’ continued focus on improving access to high-value treatments that support better long-term health outcomes.
    • * * * “Beginning July 1, Medicare beneficiaries with Part D coverage may be eligible to access certain GLP-1 medications at $50 for a monthly supply. Beneficiaries can talk to their doctor to determine whether a GLP-1 medication is right for them. CMS will share additional information for beneficiaries as the program begins.
    • “In addition, CMS continues to work with stakeholders—including providers, pharmacies, and manufacturers—to support implementation and ensure all partners have the information they need ahead of launch. 
    • “The Medicare GLP-1 Bridge builds on CMS’ broader efforts to improve access to innovative therapies and support healthier outcomes for Medicare beneficiaries. For additional “demonstration details, visit: https://www.cms.gov/medicare/coverage/prescription-drug-coverage/medicare-glp-1-bridge
  • U.S. Office of Personnel Management Director Scott Kupor, writing in his Secrets of OPM blog on Substack, optimistically discusses the state of artificial intelligence.
  • Meanwhile, KFF Health News reviews “Regulation of AI in Prior Authorization and Claims Review: A Look at Federal and State Consumer Protections.”

From the Food and Drug Administation front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.  
    • “The agency also consolidated more than 40 disparate application and submission data sources, systems and portals across all FDA centers into a new platform called HALO (Harmonized AI & Lifecycle Operations for Data).The agency began integrating HALO and Elsa so that FDA staff can query data and build workflows without having to manually upload documents within each chat. The HALO consolidation is expected to enable more penetrating deployment of AI capabilities within agency operations. 
    • “Elsa’s new capabilities once again position FDA as a leader in deploying AI tools that empower staff,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Removing tedious burdens for staff enables them to focus more on science and makes their work streams more efficient and enjoyable. We have some of the best scientists in the world and we need to take good care of them.”
  • and
    • The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient. As part of this pilot, which launched in April, the agency is conducting shorter, focused screening assessments to complement standard FDA inspections. 
    • “One-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness,” said FDA Commissioner Marty Makary, M.D., M.P.H. “For the FDA, the ability to conduct shorter, targeted assessments allows for broader surveillance coverage, enabling the agency to assess more facilities and gather critical insights without compromising regulatory rigor. For industry, these assessments can provide timely feedback while minimizing operational disruption, particularly for lower-risk establishments.”
    • One-day inspectional assessments also support the development of more robust risk models across FDA programs. Data gathered through these assessments—such as recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations—can be used to better target future oversight activities.
  • MedTech Dive tells us,
    • “The Food and Drug Administration added neurosurgical supplies to its medical device shortages list on Wednesday.
    • “The regulator sent a letter to healthcare providers warning about disruptions in availability of neurosurgical patties, sponges and strip devices, which are used to absorb fluids and protect tissue during surgery.
    • “The FDA attributed the problem to recent supplier issues, noting that Medline Industries recently recalled its neuro sponge products. The agency expects the shortage to continue through the end of the year.”

From the public health and medical / Rx research front,

  • The New York Times explains,
    • “Hantaviruses have most likely been around as long as rodents, but little was known about these pathogens before the 20th century. This rare family of viruses that rodents carry has been cited as the source of a deadly outbreak aboard a cruise ship in the Atlantic Ocean.
    • “The virus is zoonotic, meaning it can be transmitted to humans from animals. And while outbreaks have been rare, it is one of the most widely distributed zoonotic viruses on Earth.
    • “Some are Old World hantaviruses and others are New World hantaviruses,” said Sabra Klein, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health.
    • “Different species of the virus are carried by different rodents,” Dr. Klein said, adding that European strains cause less severe illnesses than those from Asia.
    • She noted that “there’s no vaccine, there’s no cure, there’s no money” in finding a cure “in part because these are so rare.”
  • The Wall Street Journal adds,
    • “Hantavirus is an unlikely source of contagion on a cruise ship. The virus isn’t as infectious between humans as fast-spreading respiratory illnesses like Covid-19 and the flu. 
    • “It belongs to a family of viruses carried by rodents and spread to humans through contact with infected urine, droppings or saliva. Only one strain—the Andes virus—has shown limited evidence of human-to-human transmission. Researchers in South Africa and Switzerland confirmed this week the virus involved in the suspected outbreak is the Andes strain.
    • “Human-to-human transmission of the Andes strain requires very close contact, like sharing food or living quarters, according Steven Bradfute, an immunologist at the University of New Mexico Health Sciences Center whose lab has sequenced hantaviruses. “It doesn’t spread into huge outbreaks,” Bradfute said.
    • “WHO and other health authorities say the threat to public health is low. 
    • “Yet the ship’s passengers are at risk, as well as perhaps people they came into close and extended contact with after leaving the ship. That is why Oceanwide Expeditions, the Hondius’s operator, plus health authorities around the world and airlines, are mobilizing to trace the paths of the ship’s travelers.”
  • Fierce Healthcare reports,
    • “The Leapfrog Group highlighted broad improvements across several patient safety measures in this year’s spring release of hospital safety grades, the first reflecting changes made after a court-ordered removal of hospitals that declined to voluntarily submit information to the watchdog group. 
    • “Top marks were handed out to 917 hospitals, with Leapfrog outlining a particularly high share of “A” hospitals in the states of Connecticut (where 64% of hospitals received an “A”), Virginia (59%), South Carolina (51%), Utah (50%) and Montana (44%). 
    • “A hospital’s assigned grade is calculated by reviewing recent data on up to 22 patient safety measures, including a 10-part Medicare composite of reported patient safety and adverse events. Among these, Leapfrog said it saw “significant improvement” in 17 measures, including those related to healthcare-associated infections and medication safety plus multiple items related to patient experience. 
    • “The good news is that hospitals across the country are making meaningful strides in patient safety and helping save countless lives,” Leah Binder, president and CEO of The Leapfrog Group, said. “But not all hospitals are the same. That’s why it’s so important for people to consult Safety Grades and do their research when choosing a hospital.”
    • “Of note, the latest release excludes 450 hospitals that did not participate in Leapfrog’s 2024 or 2025 surveys.” 
  • Beckers Hospital Review points out the “eleven U.S. hospitals have earned consecutive “A” safety grades from The Leapfrog Group since 2012.” You can see “the list of Leapfrog’s five “F” hospitals here.
  • Pulmonary Advisor notes,
    • “While vaccinations showed protective trends, prior viral infections were generally linked to an increased likelihood of future respiratory illnesses.”
  • Per MedPage Today,
    • “Updated findings from a European randomized trial continued to show that colonoscopy screening significantly reduced colorectal cancer (CRC) incidence, but its impact on CRC mortality was less clear.”
  • Following up on recent Wall Street Journal articles, Cardiology Business relates
    • “Three of the leading U.S. cardiovascular health societies have joined forces for a new statement about the importance of multidisciplinary, patient-centered decision-making when managing patients with severe aortic stenosis (AS).
    • “The Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC) and Society of Thoracic Surgeons (STS) collaborated on the joint statement, calling it a response to “recent media coverage” about transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). The primary focus of the statement appears to a feature story published by The Wall Street Journal on April 23 that included interviews with patients who experienced significant complications after undergoing TAVR. 
    • “The joint statement highlights the fact that multidisciplinary heart teams are at the center of every treatment decision for patients who present with severe AS and require an aortic valve replacement. This has been the case for many years now, but coverage from The Wall Street Journal and other mainstream news outlets is sure to grab the attention of people unfamiliar with how such treatment decisions are made. 
    • “This statement serves as a fresh reminder for the general public that cardiologists and cardiac surgeons do not take these decisions lightly. The cardiology groups said years of hard work and dedication have gone into developing the framework that is now in place.”
  • Per MedTech Dive,
    • “Neptune Medical’s gastrointestinal robot met both of its primary endpoints in a clinical trial assessing the safety and feasibility of the system to perform colonoscopies.
    • “The study followed 50 adults who underwent screening, surveillance or diagnostic colonoscopy with the robotic endoscopy system at a single center in Poland for 14 days after the procedure.
    • “The results, announced Tuesday, showed no adverse events and a 100% rate of cecal intubation, where the endoscope is guided through the entire colon to the beginning of the large intestine.”
  • and
    • “Johnson & Johnson said Tuesday that a study evaluating the investigational Ottava robotic system in gastric bypass surgery met its safety and efficacy endpoints through 30 days. The average weight loss in that time frame was 30 pounds.
    • “Results from the 30-patient study were among the pre-clinical evidence included in J&J’s submission to the Food and Drug Administration, announced in January, for de novo classification of the robot in multiple procedures in the upper abdomen. 
    • “All procedures in the prospective, multicenter study were completed robotically on Ottava without conversion to a non-robotic approach, the company said. There were no adverse events related to the device.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health exceeded first-quarter earnings expectations and raised its full-year adjusted-earnings guidance.
    • “The company reported first-quarter net income of $2.96 billion, driven by a turnaround at its Aetna insurance unit.
    • “Aetna’s medical-loss ratio was 84.6%, below analysts’ projections, but 2027 Medicare rates still fall short.”
  • Modern Healthcare relates,
    • “Humana plans to cut Medicare Advantage supplemental benefits in 2027 in a strategic shift for the insurer.
    • “Medicare Advantage payments are not keeping pace with medical costs, President and CEO Jim Rechtin said.
    • “Medicare Advantage membership was 22.6% higher in the first quarter.
    • “Humana downgraded its annual earnings guidance.”
  • Beckers Payers Issues tells us,
    • “Oscar Health reported a net income of $679 million in the first quarter of 2026, according to a May 6 earnings release. This marked the highest quarterly profit in the company’s history, nearly 2.5 times greater than profit in the first quarter of 2025.
    • “Membership reached roughly 3.2 million members, a 56% year-over-year increase. The company’s medical loss ratio was 70.5%, compared to 75.4% during the same period last year.
    • “Total revenue reached $4.6 billion, up 53% year over year. Earnings from operations were $704.1 million, more than double from the first quarter of 2025.
    • “The company also reaffirmed its 2026 guidance. The strong quarter follows a $443 million net loss in 2025.”
  • Fierce Healthcare informs us,
    • “Hinge Health boosted its full-year revenue outlook by $64 million as the company reported a stronger-than-expected first quarter and kicked off an expansion of its business beyond muscle and joint pain.
    • “The digital musculoskeletal (MSK) care provider, which went public nearly a year ago, brought in first-quarter revenue of $182 million, up 47% year-over-year from $123.8 million in Q1 2025. The company posted first-quarter adjusted earnings of 45 cents per share, significantly exceeding Wall Street analyst estimates of 12 cents per share. Hinge Health’s non-GAAP income from operations jumped 208% to $46.2 million compared to non-GAAP income from operations of $15 million during the same quarter a year ago.
    • “The company’s results easily topped Wall Street analyst estimates, with a revenue target of $172 million for the quarter and a Street estimate of $31.2 million for operating income.”
  • and
    • “Amwell, the telehealth platform formerly known as American Well, brought in $54.9 million in first-quarter revenue, down approximately 18% the same period a year ago, as executives discussed artificial intelligence and key contract renewals with investors on Tuesday.
    • “The company is shifting towards subscription revenue, and in Q1, subscription software revenue was 53% of total revenue at $24.9 million, which Chief Financial Officer Mark Hirschhorn said was down “approximately 23%” year-over-year in a May 5 call to discuss Q1 results. 
    • “Encouragingly, renewals and retention were higher than budgeted in the first quarter, providing greater confidence in the stability of our subscription base going forward,” Hirschhorn said.
    • “Amwell’s visit volume was down approximately 19% compared to a year ago, according to Hirschhorn, with 1.1 million visits in Q1. Hirschhorn said the figure is “is in line with the portfolio changes” previously disclosed by the company.”
  • The Wall Street Journal lets us know,
    • “BioNTech plans to shrink its workforce and manufacturing network to cut costs after Covid-19 vaccine demand waned.
    • “The company will affect 1,860 roles, about 22% of its 8,400-person workforce, and exit manufacturing plants.
    • “BioNTech will hand Covid shot supply to Pfizer, pivot to cancer therapies, and projects 500 million euros in annual savings by 2029.”
  • and
    • “Bayer agreed to acquire Perfuse Therapeutics, an eye disease drug specialist, for up to $2.45 billion.
    • “The acquisition aims to complement Bayer’s ophthalmology pipeline, following patent expiration issues with its Eylea drug.
    • ‘Perfuse’s lead drug candidate is an experimental treatment for glaucoma and diabetic retinopathy in mid-stage trials. Bayer will pay $300 million upfront.”
  • Per Fierce Pharma,
    • “Since the start of the decade, Eli Lilly has committed to spend more than $50 billion to bolster its United States manufacturing capabilities. But even that’s not enough to meet the needs of the rapidly growing pharma giant.
    • “On Wednesday, Lilly said that it has earmarked another $4.5 billion to further build up two of three planned production facilities in Lebanon, Indiana, some 28 miles northwest of Lilly’s headquarters in Indianapolis. The company revealed the new investment at a ribbon cutting ceremony for its genetic medicine plant in Lebanon, the first of the three new facilities at the site to become operational.
    • “Of the sum Lilly has pledged to spend for its domestic manufacturing in this decade, more than $21 billion has been allocated for the buildup in its home state. Lilly’s “evolving pipeline” and shifts in the anticipated demand for its products dictated the additional funding, the company said.”





Tuesday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Fierce Healthcare reports,
    • “Another top Republican lawmaker is floating plans to overhaul the Current Procedural Terminology, or CPT, code system. 
    • “Rep. James Comer, R-Kentucky, who chairs the House Committee on Oversight and Government Reform, penned a letter late last week to the Centers for Medicare and Medicaid Services seeking information on the CPT code system’s complexity and whether its structure is facilitating improper billing such as upcoding or unbundling. 
    • “Further, he asked the agency to describe “any constraints—statutory, regulatory or operational—that limit CMS’ ability to modify or move away from the current CPT-based system.” 
    • “The questions come as one of Comer’s colleagues in the Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy, M.D., R-Louisiana, has placed a magnifying lens on the American Medical Association (AMA) over the millions in revenue it collects managing, and advising on, the CPT code system (see that coverage below the break).
    • “Comer’s approach was less combative, and his letter to CMS does not directly place blame on the AMA. Still, it notes that Medicare and Medicaid’s codified use of the association’s proprietary system “raises concerns about federal reliance on a privately owned and licensed coding system. These concerns include fundamental questions about transparency, cost control, and whether federal healthcare policy is shaped in the best interest of patients, or by entities with financial incentives tied to the system’s continued complexity.” 
  • Kevin Moss, writing in Govexec, “weighs the costs and trade-offs of suspending FEHB for Medicare Advantage.”
  • CMS Administrator Dr. Mehmet Oz lets us know,
    • “Last year, the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS) announced a landmark pledge with major health plans from across the country to streamline and improve the prior authorization process across the entire health care industry. This pledge reflects a shared commitment to modernizing prior authorizations to create a more responsive, patient-centered experience. 
    • “Since then, the health care industry has already begun delivering results. For example, leading health plans announced in April that they eliminated 11% of prior authorizations across a range of medical services, representing 6.5 million fewer prior authorizations for patients. Other plans are rapidly scaling standardized processes and reducing requirements, demonstrating that meaningful change is not only possible—it’s happening. For example, one large national plan is eliminating authorization requirements for 30% of healthcare services and has committed to removing an additional 30% of remaining requirements by the end of 2026. 
    • “CMS is proud to announce the next chapter of that commitment: adding electronic prior authorization to the Health Tech Ecosystem. The initial landmark pledge effort brought the nation’s major health plans to the table. This new initiative brings everyone else. Health systems, hospitals, physician practices, electronic health record (EHR) vendors, and digital health developers are now joining payers as a unified coalition aligned around a single mission: making electronic prior authorization work end-to-end, on time, for every patient.” 
  • The Wall Street Journal adds,
    • “UnitedHealth Group plans to stop requiring doctors to get approvals for an array of procedures, tests and services, cutting back on a process that has long been detested by physicians and patients.
    • “UnitedHealth, parent of the biggest U.S. health insurer, said the changes will slash the number of reviews by nearly a third starting later this year. Doctors have long complained about the paperwork they must complete to get insurers’ permission for care, which can lead to delays and denials.
    • “UnitedHealthcare will stop requiring signoffs for tests including echocardiograms, some chiropractic care and certain outpatient surgeries. Also on the list is some outpatient therapy.
    • “The insurer said it is using technology backed by artificial intelligence to help reduce the need for pre-authorization reviews.
    • “The rollback is part of an effort by health insurers to counter a backlash against pre-authorizations. Rivals like CVS Health’s Aetna and Cigna Group have also made moves to ease these types of reviews.”
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced the launch of its Intelligent Generator of Research (IGoR) program, a systemic effort to deliver gold-standard biomedical science faster. The program will accelerate breakthroughs with a next-generation, AI-powered research ecosystem built to expand the experimental capabilities available to researchers. Crucially, the system will continuously refine advanced models of complex and chronic health conditions that impose a growing burden on Americans and the U.S. health system.” * * *
    • “For centuries, intrepid scientists have discovered amazing insights about health and disease. Yet, as frontier problems become more complex, the speed of discovery has been limited by what information and experimental capabilities are at researchers’ fingertips,” said IGoR Program Manager Paul E. Sheehan, Ph.D. “Through ARPA-H’s new IGoR program, we can amplify human creativity by reimagining the research ecosystem and empowering our scientists to answer ever more challenging questions about medicine’s unsolved mysteries.”
    • “The IGoR program will span 5 years. ARPA-H will solicit proposals under its Innovative Solutions Opening (ISO) and encourages collaboration among experts across disciplines to meet the program’s ambitious goals.” * * *
    • “For more information, including solicitation details and Proposers’ Day registration for this funding opportunity, visit the IGoR program page.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration (FDA) today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway. Each product is an e-liquid pod containing 50mg/ml (or 5%) of tobacco-derived nicotine. The authorized pods include Classic Menthol, Fresh Menthol, Gold, and Sapphire. This action marks the FDA’s first authorization of non-tobacco and non-menthol ENDS products.
    • “Smoking is the leading preventable source of chronic disease and premature death in the U.S. Last year, one in five deaths resulted from cigarette smoking.  More than 25 million Americans External Link Disclaimer still smoke combustible cigarettes, and they deserve better, less harmful alternatives. Under President Trump’s leadership, the FDA has authorized a number of less harmful alternatives for smokers, including 11 ENDS products from American companies.”

From the judicial front,

  • Modern Healthcare reports,
    • “A California hospital trade group sued to stop Elevance Health from implementing a policy that would cut payments to hospitals that refer some members to out-of-network providers. 
    • “In a complaint filed Monday in the state Superior Court of Los Angeles County, the California Hospital Association contended the policy allegedly violates state consumer protection and healthcare laws.” * * *
    • “Starting in June, Elevance Health plans to reduce California hospitals’ payments by up to 10% if they refer commercial patients to out-of-network physicians. 
    • “The Blue Cross Blue Shield licensee has introduced similar versions of the policy in at least 12 other states where it operates Anthem Blue Cross Blue Shield commercial plans. 
    • “The policy is intended to lower commercial healthcare costs, an Elevance Health spokesperson said in a statement. The spokesperson also said some out-of-network providers abuse the federal arbitration process enacted under the No Surprises Act of 2020.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The World Health Organization said human-to-human hantavirus transmission is possible on a cruise ship.
    • “A suspected hantavirus outbreak on the MV Hondius led to three deaths and four other infections among 147 people on board.
    • “The WHO assumes the hantavirus is the Andes variant, known in Argentina, where initial patients boarded the ship.”
  • The New York Times lets us know what doctors want you to know about cannabis and health.
    • “The government recently loosened medical marijuana rules. Experts separate fact from fiction about the drug’s safety and benefits.”
  • MedPage relates,
    • “New research is raising alarms about inhalants, which are often portrayed online as harmless while putting teens at real risk.
    • “Two new studies point to a troubling pattern: Younger teens, especially girls, may be more vulnerable — and social media is a major source of exposure.
    • “In one study, recently published in the Journal of Studies on Alcohol and Drugs, researchers reviewed 30 videos about nitrous oxide — often called “laughing gas” — posted in early 2025.
    • “Those videos averaged 23 million views. Some showed how to use it, with no age restrictions or health warnings. Others promoted “free trials” of nitrous oxide products, highlighting how easy and accessible these substances can be for teens.
    • “Inhalants remain one of the least-studied and least-discussed substance-use categories, despite the seriousness of their health risks,” said lead author Rachel Hoopsick, an assistant professor of health and kinesiology at the University of Illinois Urbana-Champaign.”
  • and
    • “Maternal respiratory syncytial virus (RSV) vaccination and infant nirsevimab immunization, administered alone or sequentially, are safe and effective, according to a study published online May 4 in Pediatrics.
    • “Christina A. Rostad, M.D., from the Emory University School of Medicine in Atlanta, and colleagues conducted a randomized, open-label phase 4 study at eight U.S. sites of mother-infant pairs to examine administration of maternal RSV prefusion F vaccination (RSVpreF) and infant nirsevimab immunization. Pairs were randomly assigned during pregnancy to receive maternal RSVpreF vaccine alone, maternal RSVpreF vaccine/infant nirsevimab at birth, maternal RSVpreF vaccine/infant nirsevimab at 3 months, or infant nirsevimab alone at birth. To ascertain safety, infant tolerability, and the magnitude and durability of RSV-A and B neutralizing antibodies (nAbs), pairs were followed for 12 months.”
  • MedPage Today adds,
    • “Older U.S. adults who received the recombinant shingles vaccine had a lower incidence rate of dementia than their peers.
    • “Receiving the recombinant zoster vaccine also was linked to reduced risks of Alzheimer’s disease and vascular dementia.
    • “The analysis assessed dementia risk with the current two-dose shingles shot in the U.S., unlike other research.”
  • and
    • “Over 6 years, about 30% of people with pure autonomic failure converted to Parkinson’s, dementia with Lewy bodies, or multiple system atrophy.
    • “The incidence rate for general conversion, 5.1 per 100 person-years, far exceeded rates in the general population.
    • “The findings were based on a meta-analysis of nine studies that included 900 people with confirmed pure autonomic failure.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Tracking microbes is challenging, particularly when there are coexisting strains of the same species within metagenomic data. However, overcoming that challenge is important for inferring transmission of both pathogenic and commensal microbes.
    • “A new tool, called TRAnsmision Clustering of Strains (TRACS), distinguishes between closely related bacterial strains. The “highly accurate algorithm” can be used for “estimating genetic distances between strains at the level of individual single nucleotide polymorphisms, which is robust to intra-species diversity within the host.”
    • “Researchers used the TRACS tool to map the transmission of SARS-CoV-2, Streptococcus pneumoniae, and Plasmodium falciparum (the causative agent of malaria) across different populations. The tool may play an important role in infection prevention, outbreak response, and the development of treatments designed to help the human microbiome fight infection. They note that this tool can be used across microbial kingdoms to uncover strain dynamics.”
  • STAT News points out,
    • “A closely watched therapy developed by Johnson & Johnson failed to show a statistically meaningful improvement for patients with inflammatory bowel disease. But the company plans to advance the drug into late-stage testing, focusing on a growing subgroup of patients. 
    • “On Tuesday, trial investigators presented the results of Johnson & Johnson’s DUET study, testing how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. It’s a follow-up to a 2022 clinical trial that showed a significant benefit to patients, nearly doubling the rates of disease remission and spurring several companies to start developing combination approaches for IBD. 
    • “Johnson & Johnson tested its combined therapy, dubbed JNJ-4804, in two Phase 2b clinical trials hitting both major forms of inflammatory bowel disease — ulcerative colitis and Crohn’s disease. In each trial, the combination therapy performed better than the individual drugs, but did not meet the primary endpoint of clinical remission. 
    • “Though the results didn’t meet the mark statistically, Esi Lamousé-Smith, the company’s vice president of gastroenterology, said they were clinically meaningful. Data showed the drug was particularly effective in participants who had previously tried at least two medications, she added.”
  • BioPharma Dive notes,
    • “Cytokinetics said Tuesday that its drug Myqorzo succeeded in a Phase 3 trial in people with a progressive heart condition, opening up a sizable market opportunity and separating the treatment from a rival therapy marketed by Bristol Myers Squibb.
    • “According to Cytokinetics, Myqorzo met the dual main goals of a study in people with the “non-obstructive” form of hypertrophic cardiomyopathy, or HCM. When compared to a placebo, people receiving Myqorzo had a statistically significant improvement in peak oxygen consumption as well as scores on an assessment of heart health after 36 weeks. The drug also hit on key secondary measures, among them a commonly used evaluation of heart symptoms.
    • “Cytokinetics said no new safety signals were identified in the trial and that the percentage of patients completing treatment was similar between those getting Myqorzo or a placebo. Drops of over 50% in left ventricular “ejection fraction”— or the amount of blood pumped into the arteries, a known risk of drugs like Myqorzo — occurred in 27 treatment recipients, versus one in the placebo group. That side effect was associated with two cases of heart failure and led 3% of participants to interrupt treatment.”

From the U.S. healthcare business front,

  • The New York Times lets us know “there’s a right and wrong way to use urgent care.”
    • “We asked experts when you should use one, and when you’re better off visiting an ER or primary care doctor instead.”
  • Beckers Hospital Review tells us,
    • “Irving, Texas-based Christus Health took over operations May 1 at Mount Pleasant, Texas-based Titus Regional Medical Center, and renamed it Christus Health – Mount Pleasant Hospital, according to a May 1 release shared with Becker’s. 
    • “Christus Health was selected as the strategic partner for Titus Regional in early February after the board of managers for the 174-bed hospital voted to move forward with the transaction. 
    • “The acquisition is part of Christus Health’s broader expansion in the area. The system opened the Christus Health Mount Pleasant Emergency Care Center Feb. 9, a $33 million, 36,000-square-foot facility that also houses a multispecialty clinic, which opened April 13, and houses cardiology, gastroenterology, primary care, pulmonology, urology and more services.”
  • and
    • “As retailers, payers and drugmakers expand access to GLP-1 therapies — with companies like Amazon and Walmart launching weight management programs — the drug class is reshaping both care delivery and pharmaceutical investment strategies.
    • “That demand is influencing drug development, with obesity treatments overtaking oncology as the largest contributor to late-stage pipeline value for the first time in 16 years, according to a May 4 report from Deloitte.”
  • Fierce Pharm informs us,
    • “With a better-than-expected first quarter in the books, Pfizer—continuing to grapple with the post-pandemic overhang from its COVID-19 franchise—is sticking with the sales forecast it set earlier this year, raising questions from at least one analyst about whether it could have lifted its outlook.
    • “Buoyed by notable sales beats from blood thinner Eliquis, pneumococcal vaccine Prevnar and breast cancer medicine Ibrance, among others, Pfizer’s overall revenue in the first quarter grew 2% year over year on an operational basis to $14.5 billion. When excluding sales of its COVID-19 products Comirnaty and Paxlovid, the growth rate (PDF) was 7% for the period on an operational basis, the company said Tuesday.
    • “Pfizer’s “strong” performance across the board helped the company deliver first-quarter revenue about $641 million above consensus forecasts, according to a May 5 note from analysts at Citi. Pfizer is also demonstrating that its commercial portfolio can flourish beyond the historically mammoth sales of its COVID-19 vaccine and antiviral, the Citi team said, noting that the company’s crop of recent launches and acquired products—including Padcev, Nurtec and Lorbrena—grew 22% operationally for the quarter.”
  • Fierce Healthcare points out,
    • “CVS announced Tuesday it will expand its use of lower-cost biosimilars and transition to interchangeable alternatives for select brands, including Johnson & Johnson’s psoriasis drug Stelara.
    • “The change comes as CVS Caremark works to increase adoption of U.S. Food and Drug Administration approved biosimilars for its most common formularies. The update aligns with the company’s broader formulary strategy, emphasizing affordability, access and value.
    • “The changes will be effective July 1, the company said in the announcement. 
    • “Our formulary plays a critical role in addressing rising drug costs without compromising clinical quality,” said Joshua Fredell, CVS Health senior vice president, in a statement. “Expanding adoption of FDA-approved biosimilars allows us to deliver significant savings for clients while supporting broader, more affordable access to proven therapies.”
  • BioPharma Dive reports,
    • “Shares of Vertex Pharmaceuticals were little changed late Monday after the Boston-based biotechnology company reported its latest round of earnings.
    • “Vertex, which has ballooned to a roughly $110 billion value thanks to the market success of its cystic fibrosis medicines, recorded $3 billion in revenue across the first three months of the year. That total was just shy of Wall Street estimates, according to Evercore ISI analyst Cory Kasimov.
    • “The lion’s share of revenue again came from Trikafta, a three-in-one oral therapy that was approved in 2019 and has the potential to work in approximately 90% of cystic fibrosis patients. It generated $2.35 billion in the quarter, down 7% from the same period a year prior. Meanwhile, revenue from a successor drug called Alyftrek grew eightfold, to $424 million, which Kasimov argued “may potentially signal a healthy switch rate.”
  • MedTech Dive relates,
    • “Olympus is partnering with EndoRobotics to distribute the South Korea-based medical device manufacturer’s endoscopic robotic devices for gastroenterology.
    • “Olympus will exclusively distribute the technologies globally, beginning in the U.S., as part of its EndoTherapy portfolio, the Tokyo-based company said Monday in the announcement.
    • “The deal comes less than a year after Olympus entered into an agreement with investment firm Revival Healthcare Capital to found a company called Swan EndoSurgical for the purpose of co-developing a robotic platform for gastrointestinal treatment.”

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.” 

Weekend update

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Notable Death

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

Thursday report

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

Scheduling note: Because one of the FEHBlog’s children is getting married on May 1, there will be no Friday report this week.

From Washington, DC,

  • Federal News Network reports,
    • “President Donald Trump swiftly signed a bipartisan legislation Thursday to fund much of the Department of Homeland Security, but not its immigration enforcement operations, shortly after the package won final approval in the House, ending the longest agency shutdown in history.” * * *
    • “The White House had urged Congress this week to act, warning that the money Trump tapped to temporarily pay TSA and other workers through executive actions was drying up.” * *
    • “With the budget resolution now adopted by the House and Senate, lawmakers will next draft the actual $70 billion ICE and Border Patrol funding bill, with voting expected in May. 
    • “Trump has said he wants it on his desk by June 1.”
  • The Wall Street Journal reports,
    • “President Trump is withdrawing his nomination of healthy-food advocate Dr. Casey Means to serve as U.S. Surgeon General, after it became clear that the champion of his administration’s Make America Healthy Again agendawas unable to secure support in the Senate for confirmation.
    • “The president said Thursday that he instead would nominate Dr. Nicole B. Saphier, the director of breast imaging at Memorial Sloan Kettering Cancer Center Monmouth and a former Fox News contributor, for the role. * * *
    • “Trump’s new nominee, Saphier, has supported Kennedy’s efforts to probe the cause of rising autism rates in the U.S., but has expressed some criticism of his approach. “Mr. Kennedy’s commitment to addressing the autism epidemic is a welcome change. But as a physician, mother and medical journalist, I am deeply concerned—not with Mr. Kennedy’s intent, but with his methods,” Saphier wrote last year in a Wall Street Journal opinion column.”
    • “She is also a supporter of the MMR vaccine and has publicly cited studies showing no link between the vaccine and autism. Saphier has praised Trump for delivering Covid-19 vaccines through Operation Warp Speed, but criticized mandates under the Biden administration that she says undermined confidence in the vaccine.”
  • STAT News adds,
    • “The Food and Drug Administration has named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research, which regulates vaccines, gene therapies, and the blood supply. 
    • “A Health and Human Services official confirmed the move, which was first reported by Politico, to STAT. 
    • “She is replacing Vinay Prasad, who left the agency on Thursday after a tumultuous tenure during which he issued a series of controversial decisions on rare disease drugs and vaccines. FDA Commissioner Marty Makary said in March that Prasad would return to the University of California San Francisco. 
    • “Szarama joined the FDA at the end of last year to serve as Prasad’s deputy. She trained as a biophysicist at Johns Hopkins and the Karolinska Institutet. Later, she worked as a research analyst at the Centers for Medicare and Medicaid Services, a director of clinical trials at Arnold Ventures, and a program manager at the Advanced Research Projects Agency for Health, according to her LinkedIn profile.” 
  • Per a CMS news release,
    • “Following overwhelming interest from prescription drug manufacturers, the Centers for Medicare & Medicaid Services (CMS) is extending the application deadline for drug manufacturers to apply to the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model. The deadline extension to June 11, 2026, from April 30, 2026, provides interested drug manufacturers, particularly those that are small to mid-sized, with more time to engage with the CMS Innovation Center, review participation information and prepare their application to join the model.
    • “Additionally, CMS is extending the deadline for drug manufacturers to enter into participation agreements from June 30, 2026, to July 17, 2026. Companies that manufacture at least one drug and that participate in the Medicaid Drug Rebate Program are eligible to apply to participate in the GENEROUS Model, which is intended to offer improved and streamlined access for state Medicaid programs to participating manufacturers’ products. 
    • “Interested drug manufacturers that wish to schedule a meeting with CMS about their potential participation in the model should contact generousmodel@cms.hhs.gov.” 
  • Tammy Flanagan, writing in Govexec, helpfully “sorts through Medicare myths in federal retirement decisions.”
    • “Common assumptions about Part B, IRMAA and FEHB coordination can obscure how coverage and costs actually play out over time.” Check it out.

From the Food and Drug Adminstration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity in 2022 to treat major depressive disorder in adults.
    • “This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer’s disease,” said FDA Commissioner Marty Makary, M.D., M.P.H. “With today’s action, patients and their families have access to an additional important treatment for complications of this devastating disease.”
    • “Agitation is a common and distressing symptom in patients with Alzheimer’s disease dementia, characterized by excessive motor activity, or verbal or physical aggression. It can significantly impact quality of life for patients and caregivers.”  * * *
    • “The FDA granted breakthrough therapy designation and priority review designation for this action. The approval of Auvelity for agitation associated with dementia due to Alzheimer’s disease was granted to Axsome Therapeutics.”
  • and
    • “The U.S. Food and Drug Administration today announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. 
    • “The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In most cases, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing. 
    • “After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances. 
    • “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”
  • Healio tells us,
    • “The FDA approved Breztri Aerosphere, a single-inhaler triple therapy, as a maintenance treatment for patients aged at least 12 years with asthma, according to a press release from AstraZeneca.” * * *
    • “Notably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.”
  • MedTech Dive informs us,
    • “The Food and Drug Administration has recommended that users of Trividia Health’s True Metrix devices switch to other methods of testing their blood glucose. 
    • “Officials made the recommendation on Tuesday because the devices show the same error code when a patient has very high blood glucose or when there is a problem with the test strip.
    • “Trividia has recalled millions of owners’ booklets and systems instruction documents in response to the problem. The meter, test strips and control solution remain on the market.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports
    • “The CDC sent an alert to state and local health departments April 27, warning that additional measles cases are expected over the next few months.
    • “With continued measles transmission in areas across North America and expected increases in international and domestic travel and large events during spring and summer, additional measles cases are anticipated in the coming months,” the alert said.” 
  • Radiology Business points out,
    • “Nearly half of women eligible for breast cancer screening are confused on when exactly they should begin said screenings, according to new survey data. 
    • “The survey was the result of a collaboration between the Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. It was distributed in early April and included a sample of more than 1,000 women. Responses revealed that 44% of participants still believe they should begin breast cancer screening starting at age 50. While this assumption is in line with prior recommendations, the U.S. Preventive Services Task Force updated its guidelines in 2024 to recommend women at average risk undergo biennial screening starting at age 40.”
  • The Washington Post points out,
    • “Some physicians and researchers have argued for years that emotional dysregulation is not peripheral to ADHD but a central, overlooked part of the condition. Yet this symptom does not appear in the formal diagnostic criteria for ADHD in the manual that doctors use to classify mental disorders. That gap has left clinicians without a clear way to categorize what they’re seeing: Are these children best understood as having severe anxiety, as being on the autism spectrum, or as something else entirely? Or does ADHD itself need to be more broadly defined?
    • “A study published in JAMA Psychiatry this year analyzing 1,154 brain scans of children and adolescents offers fresh evidence for reevaluating the medical establishment’s definition of the disorder.
    • “The researchers grouped three forms of ADHD identified in the imaging into familiar — and one less familiar — categories: predominantly inattentive; predominantly hyperactive/impulsive; and a more severe, combined presentation marked by emotional dysregulation or difficulty managing and responding to emotions in a controlled, appropriate way.
    • “The findings are part of a broader shift: Advances in brain imaging are pushing scientists beyond symptom-based labels toward biologically grounded classifications of neurological conditions — an approach already reshaping autism research, where a study published last year identified four distinct subtypes.”
  • STAT News relates,
    • “Body mass index has its limitations, but for now it’s the metric medicine often defaults to when predicting weight-related health problems. A new tool promises to better define who’s at risk for obesity complications, based on measures that include BMI but also family history, diet, current illness, and socioeconomic factors culled from medical records.” * * *
    • “We really wanted to have an integrated model that enables us to look at not one, but 18 different obesity-relevant complications,” Claudia Langenberg, co-author of a study about the new model published Thursday in Nature Medicine, said in a media briefing Tuesday. She is director and professor of medicine and population health at Precision Healthcare University Research Institute of Queen Mary University of London.
    • “The new tool, called OBSCORE, stratifies 10-year risk for different outcomes at 5.7%, 1.8%, 0.9%, 0.4%, and 0.1% for death from, for example, cardiovascular causes. 
    • “What needs to happen next is to take this very helpful score and to incorporate it, as the team have done, with evidence from trials to show that people are not only at risk, but estimate what their capacity to benefit is — and then the cost-effectiveness of intervention,” co-author Nick Wareham, co-director of the Institute of Metabolic Science at the University of Cambridge, said at the briefing.”
    • “Experts not involved in the study praised its ambition to predict obesity’s serious ramifications, but they differed on how well this step toward early recognition and refined response might play out.”
  • The Washington Post informs us,
    • “A drug taken by thousands of Americans to improve longevity might have an unexpected side effect, a study has found. It may blunt some of the health benefits of exercise.
    • “The drug, rapamycin, is approved by the Food and Drug Administration to prevent organ-transplant rejection in people. But recent studies in yeast, flies and mice showed that relatively low doses of the drug often increase the creatures’ lifespans, prompting many longevity enthusiasts to start using it off-label to extend their lifespans.
    • “The new study, published this month in the Journal of Cachexia, Sarcopenia and Muscle, is among the first to look at interactions between rapamycin and exercise. The researchers anticipated rapamycin would enhance the effects of exercise, while also initiating health improvements of its own.”
    • “But the results surprised them, said Brad Stanfield, a physician and researcher in Auckland, New Zealand, who led the study. The sedentary, older people taking a low dose of rapamycin once a week during the study wound up gaining less strength and physical function from an exercise program than other volunteers of the same age who were taking a placebo. They also developed more aches, fatigue and, in one case, a serious infection.
    • “These findings resonate because, exercise is the most effective way to improve health and longevity as we age. “It is important to understand how potential health span-extending drugs” such as rapamycin “interact with other health span-extending treatments like exercise,” said Benjamin Miller, who studies aging and metabolism at the Oklahoma Medical Research Foundation in Oklahoma City. He was not involved with the new study.
    • “Since exercise is the benchmark,” he continued, “we do not want to inhibit its potential benefits.”
  • Health Day tells us,
    • “Screening for dementia doesn’t appear to stress out seniors’ families
    • “Family members whose seniors received screening were no more anxious than those who didn’t 
    • “However, screening alone did not lead to family members better prepared for caregiving.”

From the healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “Cigna Group will exit the Affordable Care Act market next year, the latest sign of turmoil in a business that has been hit hard by the loss of federal subsidies.
    • “Cigna will be the second major health insurer to leave the rapidly shrinking ACA market, after CVS Health’s Aetna stopped offering plans at the start of this year.” 
  • Modern Healthcare adds,
    • [Cigna] reported first-quarter profit ahead of Wall Street estimates and lifted its outlook for the year as healthcare expenses in its medical plans came in lower than forecasts.
    • Adjusted earnings of $7.79 a share topped the average analyst estimate in a Bloomberg survey. Cigna nudged its 2026 profit outlook up by 10 cents a share to at least $30.35, the company said in a statement Thursday. A key gauge of medical costs was more favorable than Wall Street expected. 
    • The results extend a string of favorable reports from US health insurers for the start of 2026. Cigna’s medical plan business drove the company’s earnings, while the company’s Evernorth health services segment, which includes the largest US drug benefits manager, powered revenue growth. Selling, general and administrative expenses declined from a year ago.
  • Fierce Healthcare relates,
    • “Tenet Healthcare topped its earnings expectations for the year’s first quarter, with CEO Saum Sutaria, M.D., crediting the company’s long-term strategy and “old-fashioned discipline” in the face of volume disruptions plaguing providers in the opening months of 2026.
    • “The company’s net income for the quarter was $8.01 per diluted share ($702 million), or a market consensus-beating 10.6% year-over-year increase to $4.82 per share after adjustments (including over $400 million received from the early severance of a revenue cycle contract with CommonSpirit Health). Net operating revenues increased 2.8% year over year to $5.37 billion, falling short of the market’s consensus estimate.
    • “Executives said they were pleased with the performance of both major segments of Tenet’s business, its ambulatory surgery business and its hospitals.” 
  • and
    • “Parsley Health, a functional medicine provider, is now in-network with all major commercial insurers nationwide.
    • “The company’s in-network reach spans plans covering 150 million lives, including Aetna, Cigna, UnitedHealthcare, Blue Cross Blue Shield, Humana and Centene. Eligible services covered include provider visits, diagnostic testing and prescriptions. Parsley members must pay an annual non-covered program fee of $1,500 for wraparound support.
    • “The announcement builds on Parsley’s phased expansion into insurance over the past two years, which began in New York and then California. Today’s nationwide expansion represents a tenfold increase in coverage, per the company. The company offers healthcare via telehealth nationwide or in-person in Los Angeles and New York City.” * * *
    • “Functional medicine aims to look at the whole person and get under the hood of symptoms to identify and address root causes of disease. Parsley takes a multidisciplinary approach, with members getting a care team of board-certified doctors, registered nurses, functional nutritionists, care coordinators, member experience advisors and access to the digital platform to track progress, access data and more. Members also get unlimited messaging with their care team.” 
  • The Wall Street Journal tells us,
    • “Booming sales of weight-loss shots fueled strong revenue and profit growth for Eli Lilly LLY  in the latest quarter, as robust consumer demand helped offset falling prices for the drugs.
    • “The results blew past Wall Street expectations, and Lilly raised its forecast for full-year 2026 sales and profit.” * * *
    • “The results cement the Indianapolis company’s dominance in the anti-obesity drug market as it seeks to extend that to weight-loss pills. Lilly released its new weight-loss pill Foundayo this month, competing with Novo Nordisk’s Wegovy pill, which came out in January.
    • “Early prescription data showed a slower start for Lilly’s pill than for Novo Nordisk’s, but analysts predict Lilly’s pill will eventually be a big seller.
    • “Both companies think there is a large, untapped market for pill versions of weight-loss drugs, because some people don’t like needles or find pills more convenient.”
  • and
    • “Merck reported higher first-quarter sales and raised its full-year earnings guidance as demand for its flagship Keytruda cancer drug continues to grow.
    • “Sales rose 5% to $16.29 billion, boosted by 12% growth for Keytruda. Wall Street had expected $15.85 billion, according to FactSet.
    • “The company has been adding to its portfolio as it braces for Keytruda to lose the protection of its main U.S. patent, which expires in 2028, opening the door for lower-cost versions to compete.
    • “Last year, the FDA approved a form of Keytruda administered by injection rather than intravenously, which could help the company offset the impact of the patent expiration. Merck has said the new form of the drug, called Qlex, provides greater convenience as it can be offered in a wider variety of settings and can be given in one minute every three weeks as opposed to a 30-minute IV infusion.
    • ‘In the first quarter, the company recorded $128 million in Qlex sales.”
  • and
    • “Bristol Myers Squibb BMY posted higher first-quarter revenue boosted by its portfolio of newer treatments for heart and blood conditions.
    • “The biopharmaceutical company on Thursday posted a profit of $2.68 billion, or $1.31 a share, compared with $2.46 billion, or $1.20 a share, a year earlier.
    • “Stripping out certain one-time items, adjusted per-share earnings were $1.58, ahead of the $1.42 anticipated by analysts, according to FactSet.
    • “Revenue rose 3% to $11.49 billion. Analysts surveyed by FactSet forecast revenue of $10.93 billion.
    • “Sales in Bristol Myers Squibb’s growth portfolio rose 12%, driven by Camzyos, Breyanzi and Reblozyl. The drugs are designed to treat heart disease, lymphoma and blood disorders, respectively.”
  • Health Exec notes “six things the hospital-at-home model needs to scale up nationally.”
  • Beckers Payer Issues calls attention to “five ways insurers are betting big on AI.”
    • “Payers have been experimenting with internal and member-facing capabilities, while grappling with health system AI use, as well. As insurers build upon their substantial investments and weigh how humans can stay “in the loop,” here is where that money is actually going.”

Midweek update

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “The House took a major step toward providing funding for immigration enforcement agencies by adopting a Senate-backed budget resolution Wednesday evening.
    • “Now that both chambers have adopted the budget blueprint, lawmakers can move forward with a filibuster-proof reconciliation bill to provide around $70 billion in immigration enforcement funding. That money is designed to sustain the Immigration and Customs Enforcement and Customs and Border Protection agencies for the remainder of President Donald Trump’s term.
    • “The vote on the GOP-written resolution was 215-211, falling strictly along party lines. Rep. Kevin Kiley of California, a Republican-turned-independent from a swing district, voted “present.”
  • The Government Accountability Office released a report today finding
    • he Federal Employees Health Benefits program is the largest employer-sponsored health insurance program in the United States. The Office of Personnel Management is responsible for managing fraud risks in the program.
    • But OPM’s process for verifying whether health care providers were eligible to provide care under the program isn’t always working. For example, our data analyses identified claims from providers who were deceased or excluded from other federal programs for certain violations.
    • Our [fifteen] recommendations would improve OPM’s process for verifying health care provider eligibility and reduce risks to the program.
  • Fedweek relates,
    • In a memo issued on April 28, 2026, Office of Personnel Management (OPM) Director Scott Kupor advised federal agencies to exclude all employees in Schedule C and Schedule G General Schedule (GS) positions from the performance appraisal requirements under Subchapter I of Chapter 43 of Title 5, including requirements for performance standards, progress reviews, and annual ratings of record.
    • “This directive simplifies personnel management for these excepted-service political appointments, which are now treated as “at-will” roles where retention and removal do not hinge on formal performance ratings. 
    • “The memo clarifies that these employees operate outside the structured appraisal frameworks that apply to most competitive-service GS employees. They are excluded due to the confidential, policy-determining, policy-making, or policy-advocating nature of their positions.
    • “This latest memo is not a surprise, as it is a step in implementing [Schedule F] policies that have already been formulated.”
  • The Hill tells us,
    • “The Trump administration is no longer allowing federal funds to be used for purchasing or distributing test strips that can determine if street drugs have been mixed or cut with fentanyl or other contaminants, a reversal that comes amid the administration’s broader opposition to harm reduction practices. 
    • “In an open letter to federal grantees, the Substance Abuse and Mental Health Services Administration said it was ending the practice, which it has championed since 2021, because the strips are “intended for use by people using drugs.” 
    • “However, the notice emphasized that federal funds can still be used for test strips to be used by public health officials, law enforcement, medical workers and others in professional settings.  
    • “Test strips cost about $1 each and can detect drugs like fentanyl or animal tranquilizers like xylazine and medetomidine. Many states have legalized test strips in an effort to slow the number of overdose deaths.” 
  • The American Hospital Association News informs us,
    • “The Agency for Healthcare Research and Quality has issued a request for nominations for candidates to serve on the U.S. Preventive Services Task Force. While all nominees will be considered, AHRQ said it encourages nominations of physician specialists in anesthesiology/pain management, cardiology, endocrinology, family medicine, gastroenterology, hematology/oncology, internal medicine, obstetrics and gynecology, pediatrics, preventive medicine and radiology, as well as experts in health economics. The agency said it will also consider applications from physicians in specialties including but not limited to surgery, laboratory medicine/molecular pathology and clinical genetics. AHRQ is also seeking wide geographic representation and experience in diverse settings, including individuals with expertise in rural medicine. Nominations must be received by AHRQ electronically by May 23 to be considered for appointment beginning in June.”
  • Bloomberg Law adds,
    • “The Trump administration is appealing a federal district court order that temporarily blocked US Health Secretary Robert F. Kennedy Jr.’s changes to the nation’s childhood vaccine schedule.
    • “The US Department of Justice filed a notice Wednesday to appeal an order issued March 16 by Judge Brian Murphy of the US District Court for the District of Massachusetts that halted decisions made by a vaccine advisory panel earlier this year to drastically reduce the number of recommended shots for kids. 
    • “The appeal to the US Court of Appeals for the First Circuit challenges the judge’s decision to temporarily block Kennedy’s appointments of 13 members to the panel, the Advisory Committee on Immunization Practices, which helps determine which vaccines are covered by insurance and provided for free for some children.
    • “The committee was scheduled to convene on March 18-19 at the US Centers for Disease Control and Prevention headquarters, but the court ruled it can’t meet and the meeting was subsequently postponed.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration on Wednesday released the results of a major study examining the safety of infant formula sold in the U.S., finding that most products contained low or undetectable levels of contaminants including heavy metals.
    • “The findings come amid “Operation Stork Speed,” the Trump administration’s sweeping review of U.S. infant formula ingredients. Federal officials said the results reinforce that the nation’s infant formula supply is safe, while adding that the FDA will continue additional testing as part of its continuing monitoring and oversight efforts.
    • “We tested more infant formula than ever before, and the results are clear: most products meet a high safety standard—but even small exposures matter for newborns,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement.” * * *
    • “Although the results didn’t break down findings by specific companies, leading manufacturers welcomed the report.”
  • MedTech Dive relates,
    • “Medtronic received Food and Drug Administration approval for its next-generation mitral valve and has launched the device in the U.S., the company said Wednesday.
    • “Called Mosaic Neo, the bioprosthetic valve is designed to be implanted through sternotomy, which requires separating the breastbone to reach the heart, or through minimally invasive surgery.
    • “In addition, the first concomitant procedure was performed where the Mosaic valve was implanted alongside Medtronic’s Penditure left atrial appendage exclusion device, the company said. The Penditure clip is designed to close the left atrial appendage to help prevent clots from entering the bloodstream.”
  • Cardiovascular News informs us,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about a potential safety issue with certain Relay Pro Thoracic Stent Grafts from Terumo Aortic. 
    • “These devices are used by interventional cardiologists and vascular surgeons to repair damaged or weakened sections of a patient’s thoracic aorta. However, Terumo Aortic has received multiple reports of the stent being unable to unclasp from the delivery system. When this happens, it can lead to significant risks, including death. As of April 23, in fact, three deaths have been directly linked to this issue.
    • “Difficulties in releasing the stent graft may result in delay of procedure, stent graft displacement, and an inability to release the stent graft,” according to the FDA’s warning. “This may require conversion to open surgical repair to release the clasp and can result in patient death. Please be advised that this failure mode can occur without prior warning and no device-based bailout method has been identified for this specific scenario.”
  • and
    • “Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for Ultreon 3.0, its next-generation coronary imaging platform.
    • “Ultreon 3.0, an update of the company’s Ultreon 2.0 technology, uses advanced artificial intelligence (AI) algorithms to capture and evaluate optical coherence tomography (OCT) images, delivering real-time guidance during percutaneous coronary intervention (PCI) procedures. OCT is a critical modality for the diagnosis, treatment and management of coronary disease. This platform was built to give clinicians detailed OCT images from inside the blood vessels. It then uses those images to assess the blockage being treated and make recommendations to the PCI operator on the selection and placement any stents.
    • “Ultreon 3.0 represents a pivotal step forward in how we treat and ultimately care for our patients,” Evan Shlofmitz, DO, director of interventional cardiology at St. Francis Hospital and Health Center in Roslyn, New York, said in a statement. “This next-generation platform, combining imaging and AI, doesn’t just improve upon existing technology—it leapfrogs it. By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Marriage is linked to a lower risk of developing cancer, recent research found.
    • “A study of more than 4 million cancer cases in the U.S. found that cancer rates were about 68% higher among men who have never married compared with those who have. For never-married women, the relationship was even more pronounced, with cancer rates roughly 83% higher, according to research published recently in the journal Cancer Research Communications.
    • “Married people tend to have greater economic stability and better support systems, and they are more likely to stick with treatment, said Paulo Pinheiro, professor of cancer epidemiology at the University of Miami School of Medicine’s Sylvester Comprehensive Cancer Center and co-author of the findings. 
    • “Previous studies have found that married people who have cancer tend to get diagnosed earlier and have better survival rates. 
    • ‘The recent study looked at data collected between 2015 and 2022 encompassing more than 100 million people aged 30 or older from across 12 states. About 20% were unmarried.” 
  • Healio informs us,
    • “A large measles outbreak in South Carolina has ended after nearly 1,000 cases.
    • “More than 8,000 measles vaccinations were administered during the outbreak, which began in October.”
  • Health Day relates,
    • “Mail-in colon cancer kits can extend easy, affordable cancer screening to low-income folks, study shows
    • “People preferred returning test kits that look for cancer-related DNA
    • “That might be because the kits had more comprehensive support from their manufacturer, researchers said.”
  • Medpage Today tells us,
    • “Over 15 years, a moderately protein-restricted diet was tied to a lower risk of starting dialysis in patients with stages 3 or 4 chronic kidney disease.
    • “Associations with a 50% eGFR decline and all-cause mortality approached, but did not achieve, statistical significance.
    • “Findings support guideline-based care while emphasizing practicality, the researchers noted.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (Takeda Pharmaceutical Co., Ltd.) for narcolepsy type 1.
    • “Current treatments for narcolepsy do not address the underlying cause of the condition, and many patients report incomplete relief from narcolepsy symptoms despite multiple medications,” said ICER’s Senior Vice President of Research, Foluso Agboola, MBBS, MPH.  “ICER’s analyses found that oveporexton, the first medication for narcolepsy type 1 that directly addresses the underlying cause of the condition, is effective in promoting wakefulness, improving quality of life, and appears to offer better health benefits than current options. Pricing choices that balance innovation rewards while addressing long-term value and patient access will be important topics at the public meeting.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on May 14, 2026. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.” * * *
    • “Oveporexton has not yet been approved by the FDA for narcolepsy type 1. The manufacturers have not yet announced a US price for the therapy if approved. ICER calculated a health benefit price benchmark (HBPB) between $50,400 and $59,400 per year.”

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

  • The Wall Street Journal reports,
    • “Humana reported lower first-quarter profit, with shares down 7.4% in premarket trading, due to lower 2026 Medicare Advantage Star Ratings.
    • “The company reiterated its full-year adjusted-earnings guidance but cut its nonadjusted earnings outlook to at least $8.36 a share.
    • “Humana incurred charges for a multiyear transformation program and faced higher medical costs, particularly from older people using services.”
  • Beckers Payer Issues relates
    • “Blue Cross NC recorded a net loss of $497.3 million in 2025, according to regulatory filings.
    • “The insurer posted a net income of $68.5 million in 2024 and $133 million in 2023.” * * *
    • ‘The company reported total assets of $7.2 billion as of year-end 2025, with capital and surplus of $3 billion. Medicaid was the company’s largest line of business by direct premiums written at $3.5 billion, followed by Medicare at $2.2 billion, the Federal Employees Health Benefits program at $1.8 billion, Medicare supplement at $397.4 million, and dental at $101.3 million.”
  • and
    • “BlueCross BlueShield of Tennessee recorded a net income of $168.4 million in 2025, a 62% decline from $446.8 million in 2024, according to regulatory filings.
    • “In its 2025 impact report, the insurer said 89 cents of every premium dollar collected last year was used to pay member claims, and medical and pharmacy claims payments have increased 25% over the past five years.
    • “The company reported total assets of $6.7 billion as of year-end 2025, with capital and surplus of $5.4 billion. Medicare was the company’s largest line of business by direct premiums written at $2.5 billion, followed by the Federal Employees Health Benefits program at $1.1 billion, dental at $172.6 million, Medicare supplement at $153.5 million, and vision at $37.4 million.”
  • Fierce Healthcare tells us,
    • “Teladoc Health reported a 2% decline in revenue in the first quarter, but the telehealth giant touted “meaningful progress” in scaling insurance coverage for its BetterHelp mental health business as a catalyst for future growth.
    • “The virtual care company reported Q1 revenue of $613.8 million compared to $629 million a year ago. Access fees revenue decreased 8% to $484.7 million.
    • “U.S. revenue dropped 6% to $491.5 million while revenue from international markets rose 17% to $122.3 million. The company’s integrated care segment revenue inched up 2% to $395.4 million and its BetterHelp segment saw revenue fall 9% to $218.4 million. Aside from access fee revenue, Teladoc Health reported “other revenue” jumped 25% to $129.2 million during the quarter.
    • “The company reported adjusted EBITDA of $58.2 million, essentially flat year-over-year, and the company narrowed its losses from a loss of $93 million in Q1 2025 to a net loss of $63.8 million, or $0.36 per share, in the most recent quarter.”
  • Beckers Hospital Review discusses “three barriers to GLP-1 adherence — and how systems are overcoming them.”
  • Health CIO informs us,
    • “Nearly 80% of provider-payer partnerships recognized in KLAS Research’s 2026 Points of Light report centered on value-based care workflows. That figure stood at 48% the year before. The shift signals that interoperability has graduated from differentiator to baseline expectation. Success in provider-payer collaboration will now hinge on whether shared data drives measurable financial and clinical outcomes.
    • “The report, released in April 2026 and produced through KLAS’s K2 Collaborative, profiles 24 award-winning partnerships. KLAS validated each through structured interviews conducted between September 2025 and February 2026. Of those 24 collaborations, 23 involved interoperability or clinical data exchange in some form. Federal mandates such as CMS-0057-F are accelerating adoption of FHIR-based APIs and HL7 Da Vinci implementation guides. As a result, payers and providers are moving toward standardized exchange that supports patient access, payer-to-payer transfers, and electronic prior authorization.”
  • BioPharma Dive points out,
    • “Teva Pharmaceutical is wagering up to $900 million on a biotechnology company built around a potential treatment for Tourette syndrome.
    • “Through an acquisition announced Wednesday, Teva will take control of privately held Emalex Biosciences and its drug ecopipam, which is in late-stage clinical testing. Ecopipam is meant to inhibit “D1,” a kind of dopamine-regulating protein that research suggests may play a role in the involuntary movements, or tics, associated with Tourette’s. The antipsychotics often used to treat this disorder target a different but related protein, D2.
    • “The companies expect their deal to close sometime between July and the end of September. Terms hold that Teva will pay $700 million up front and possibly as much as $200 million more if ecopipam hits certain commercial goals. Emalex shareholders will be eligible to receive sales-based royalties as well.”

Tuesday report

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

From Washington, DC,

  • STAT News reports,
    • “The four health system CEOs summoned before [the House Ways and Means Committee] Tuesday likely breathed sighs of relief early in the hearing, when it became clear they had friends in the audience. 
    • “Instead, committee members largely blamed the other party’s health care policies for driving U.S. health care prices to levels inaccessible to many Americans.” * * *
    • “A topic that came up frequently was hospitals’ practice of charging facility fees at their outpatient clinics, rendering the same services much more expensive when provided there compared with independent physician clinics. 
    • “Rep. Jodey Arrington (R-Tex.) said that both Republican and Democratic presidents have included site-neutral payment reform, which would equalize Medicare reimbursement to hospital-owned and physician-owned outpatient clinics, in their budgets, “but we don’t do jack squat about it.” He asked the CEOs to raise their hands if they supported site-neutral payment reform. None did. 
    • “Smith echoed that sentiment, noting that Congress, including his committee, has tried to implement site-neutral payments. “But every time we try to advance these so-called site-neutral policies, big hospitals fight us tooth and nail,” he said.”
  • AHIP notes,
    • “Hospital costs account for more than 40 cents of every premium dollar – more than any other category – and many hospital systems continue to raise their prices at rates that dwarf inflation while also sticking patients with high bills with layers of opaque fees. Instead of blaming others, the hospital industry should stop their anticompetitive consolidation, opaque billing practices and unaffordable price hikes that continue to drive Americans’ premium costs higher.” —Chris Bond, AHIP Spokesperson” * * *
    • “Health plans are doing everything in their power to shield Americans from the high and rising costs of medical care and are committed to working constructively with policymakers to advance common-sense, bipartisan reforms. Policymakers have a clear opportunity to act, including:
      • “Protecting consumers with site-neutral payment reforms to level the playing field on prices, reduce patient cost-sharing, and lower premiums — saving more than $170 billion over 10 years.
      • “Promoting greater competition among hospitals by blocking anticompetitive hospital mergers.
      • “Requiring price transparency so patients and employers can see what they’re actually paying for.”
  • The American Hospital Association News adds,
    • “The AHA submitted a statement for the record to the House Ways and Means Committee for its April 28 hearingwith health system CEOs.
    • “In the statement, the AHA outlined steps to improve health care affordability while warning against policies that could limit patient access to care.
    • “We understand the importance of making sure high-quality care is affordable and accessible,” AHA stated. “As such, hospitals have long been leaders in advancing meaningful solutions to complex health care challenges, including the issue of affordability. That spirit continues today as hospitals across the country work to reduce the cost of care by improving efficiency, embracing innovative technologies and redesigning how services are delivered. Many are investing in preventive care and care coordination programs that help patients manage chronic conditions, avoid unnecessary hospital visits and stay healthier at home. These efforts not only improve patient outcomes but also lower overall costs for patients, families and the health care system.”
  • Fierce Healthcare offers more details on the hearing and also reports,
    • “The National Academy of Medicine recently kicked off its second Change Maker Accelerators program, aimed at aiding healthcare organizations in implementing and measuring well-being efforts.
    • “The NAM’s voluntary yearlong program builds on its 2022 National Plan for Health Workforce Well-Being framework. Organizations must apply, and participation is free. 
    • “The program is part of NAM’s broader Change Maker campaign, which works to advance the national plan’s priority areas. About 520 organizations have become members since the campaign launched in October 2023.”
  • KFF Health News explores how the $50 billion Federal Rural Health Fund will be distributed.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The U.S. Food and Drug Administration seeks to accelerate clinical trials of new medicines by using artificial intelligence to streamline the laborious process of collecting and submitting study data.
    • “Typically, medical centers involved in clinical trials pull study data from electronic-health records and enter them manually into a data-capture system. Then, the drug company developing the medicine reviews the data and submits them to the FDA.
    • “The FDA this summer plans to pilot an approach that would upend this practice, which hasn’t changed much in decades. Through the program, AI would extract data directly from electronic records so they can be submitted in real-time to both the FDA and the pharmaceutical company. 
    • “If successful and adopted widely, the new approach could speed drug development and help the U.S. compete with other nations making a strong push into biotechnology, officials said.”
  • Fierce Pharma relates,
    • “After breaking through the blockbuster sales threshold in 2025, AstraZeneca’s three-in-one inhaler Breztri Aerosphere has passed another crucial milestone as it chips in on the British drugmaker’s goal to reach $80 billion in revenues by 2030. 
    • “On Tuesday, the FDA approved Breztri in its second indication, clearing the triple combination therapy of budesonide, glycopyrrolate and formoterol fumarate as a maintenance treatment for asthma in adults and kids ages 12 and older. Breztri was first greenlit in the U.S. in 2020 as a maintenance treatment for chronic obstructive pulmonary disease (COPD). 
    • “The new nod will unlock a substantial market for Breztri, which is one of several respiratory products driving significant sales ambitions at AstraZeneca. Last year, the drug surpassed the billion-dollar sales threshold for the first time, with revenues growing (PDF) 22% at constant currencies to nearly $1.2 billion.”
  • and
    • “Earlier this year, when the FDA asked Amgen to pull its rare disease drug Tavneos from the market, the California drugmaker denied the request. Now, the U.S. regulator is applying more pressure.
    • “The FDA’s Center for Drug Evaluation and Research (CDER) has proposed to withdraw the approval of Amgen’s oral medicine, saying new information indicates the data was “manipulated” to facilitate its green light.
    • “CDER said in a letter (PDF), which also called out Amgen’s subsidiary ChemoCentryx, that Tavneos is not effective and that its application for approval to treat ANCA-associated vasculitis included untrue statements. In addition, CDER noted that it is “increasingly concerned about the safety of Tavneos,” pointing to cases of serious drug-induced liver injury (DILI).
    • “The FDA said that Amgen’s options are to pull the drug from the market or request a hearing.
    • “The company is evaluating its next steps, an Amgen spokesperson said in an email.
    • “We remain confident in Tavneos as a safe and effective medicine, supported by years of clinical data and real-world evidence,” the spokesperson wrote. “Our perspective on the benefit-risk profile of Tavneos differs from the Agency’s.”

From the judicial front,

  • Bloomberg Law reports,
    • “A New Jersey federal judge accepted Purdue Pharma LP’s multibillion-dollar criminal plea deal with the US government on charges related to its dissemination of addictive opioid products, a critical step for the OxyContin maker’s $7.4 billion bankruptcy plan.
    • “Judge Madeline Cox Arleo of the US District Court for the District of New Jersey on Tuesday apologized to opioid addiction victims and their family members as she accepted Purdue’s 2020 guilty plea for misleading federal regulators about its efforts to prevent drug diversion and paying illegal kickbacks to prescribing doctors.
    • “It is the best choice that I have and I am satisfied it is the best choice at this juncture,” she said. “I wish there was more I was empowered to do.”
    • “The agreement with the Department of Justice allows Purdue to consummate its Chapter 11 bankruptcy plan, largely structured around a deal with the company’s Sackler family owners to pay at least $6.5 billion to compensate personal injury victims and fund opioid abatement efforts by local governments across the country.
    • “The sentencing hearing was put on hold for several years as Purdue’s bankruptcy was prolonged by appeals over provisions releasing the Sacklers from legal liabilities related to the company’s production and sale of addictive opioids.
    • “A revised version of the plan, approved by a New York bankruptcy judge in November, gives creditors the ability to opt out of releasing claims against Sackler family members in exchange for a smaller settlement distribution.”
  • Healthcare Dive relates,
    • “The frequency of medical liability lawsuits filed against doctors is falling over time but they are still common, according to a research report released this week from the American Medical Association.
    • “Risk of lawsuits is higher among certain specialities and increases the longer doctors practice medicine, the AMA reported.
    • “In a separate AMA report, medical liability insurance is also getting more expensive for some doctors, with premiums growing at consistent rates not seen in two decades. The risk of being sued “not only challenges physicians but it increases practice expenses, reinforces defensive medical practices, and drives up health care costs for patients and families,” Dr. Bobby Mukkamala, AMA president, said in a statement.”

From the public health and medical / Rx research front,

  • The Washington Post tells us five things that OB/GYNs want you to know about perimenopause.
    • “Estrogen and progesterone are the main drivers”
    • “It can last for months or years”
    • “Symptoms are wide-ranging, but a few are very common”
    • “There’s no specific test to diagnose it”
    • “The right treatment can be life-changing”
  • MedPage Today reports,
    • “About a quarter of survey respondents who met USPSTF eligibility criteria were up to date with lung cancer screening in 2024 — an increase in prevalence of 6 percentage points since 2022.
    • “Lung cancer screening rates were low compared with those for other cancers, including colorectal, cervical, and breast cancers.
    • “Up-to-date prevalence was uneven depending on age, race and ethnicity, and insurance status.”
  • Healio relates,
    • “Extensively drug-resistant Shigella is on the rise in the United States, according to data published by the CDC.
    • “Shigella is a bacterium that can be sexually transmitted and causes infectious diarrhea. The new study published in MMWR found that among nearly 17,000 Shigella isolates submitted to a CDC surveillance network, the proportion of extensively drug-resistant (XDR) isolates rose from 0% in 2011 to 8.5% in 2023. Around one-third of patients with XDR Shigella ended up hospitalized.” * * *
    • “Shigella causes an estimated 450,000 infections each year nationwide, making it a leading cause of diarrheal illness, according to the CDC. Common symptoms of the infection include diarrhea, fever, stomach pain and experiencing a feeling to pass stool when bowels are empty. 
    • “Meanwhile, Jason E. Zucker, MD, assistant professor of medicine at Columbia University Medical Center,  said most shigellosis cases will resolve on their own. He also said the rise of XDR Shigella “should prompt a broader conversation about sexual health, make sure the patient is up-to-date on STI screening, discuss [pre-exposure prophylaxis] if they’re not already on it and assess whether they’re connected to HIV prevention or care.”
  • The latest post of NIH Research Matters covers the following topics:
    • AI tool predicts patients at risk of intimate partner violence
      • “A new artificial intelligence tool can predict patients who are likely to experience intimate partner violence years before they seek help. 
      • “The tool may eventually help health care providers identify patients at risk of intimate partner violence and provide early interventions.”
    • Weakened gut-brain connection may contribute to memory loss
      • “Researchers found that changes to gut bacteria in aging mice hindered communication from the gut to the brain and led to worse performance on memory tasks.
      • “If these results hold true in humans, they could inspire treatments to prevent, reduce, or even reverse age-related cognitive decline.”
    • Boosting the immune response to brain cancer
      • Stopping certain immune cells from using fructose for fuel enhanced the immune response to brain cancer in mice.
      • The results point to a way to make immunotherapies more effective for a form of cancer that is often resistant to their effects.
  • Cardiovasular Business tells us,
    • “Treating patients with a sirolimus-eluting balloon (SEB) during percutaneous coronary intervention (PCI) is a safe, effective alternative to traditional stenting, according to new data presented at the SCAI 2026 Scientific Sessions and CAIC-ACCI Summit in Montréal, Canada.
    • “Interventional cardiologists typically use a drug-eluting stent (DES) during PCI to keep the artery permanently open. Leaving these stents in a patient’s artery can lead to complications, however, and the Selution SLR SEB from Cordis was designed to help keep that artery open without a stent being left behind. The Selution SLR SEB is a drug-coated balloon that provides patients with a sustained release of sirolimus over time thanks to tiny “MicroReservoirs.” The Selution SLR SEB was previously the topic of two late-breaking studies at TCT 2025 in San Francisco. Both trials linked the device to potential benefits for patients undergoing PCI.” 
  • MedTech Dive discusses,
    • Four studies to know from Heart Rythm Society’s 2026 conference.
    • Boston Scientific, Abbott and Medtronic shared new cardiac device data at the annual Heart Rhythm Society meeting, where market share shifts in pulsed field ablation were on analysts’ minds.
  • BioPharma Dive lets us know,
    • “Boehringer Ingelheim said its dual-acting obesity shot succeeded in a Phase 3 trial, announcing Tuesday that the therapy, survodutide, helped enrollees who received it lose significantly more weight than those who got a placebo.
    • “Notably, the shot, which Boehringer licensed from Zealand Pharma, also showed signs of helping study participants reduce weight while preserving muscle. That purported benefit could address a weakness of Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, both of which have been shown to lower lean body mass along with fat.  
    • “In notes to clients following the announcement, Wall Street analysts described survodutide’s weight loss effects as comparable to Wegovy but short of what’s been seen in testing of Zepbound. Multiple analysts are also awaiting more details on the drug’s side effects as well as data from a trial in the liver disease MASH before making further judgments about its commercial potential.”

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

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. recorded a net loss of more than $1.9 billion in 2025, a sharp reversal from the prior two years, according to regulatory filings.
    • “The Chicago-based organization, which operates the Blue Cross and Blue Shield plans in Illinois, Montana, New Mexico, Oklahoma and Texas, posted a net income of $659 million in 2024 and $1.4 billion in 2023.
    • “HCSC reported total revenue of $66.8 billion in 2025, up from $62.8 billion the prior year. Benefit expenses, however, rose to $63.1 billion from $57 billion, and the company’s net underwriting loss widened to $3.5 billion from $572 million in 2024. HCSC attributed membership and revenue growth to its purchase of the Cigna Group’s Medicare and CareAllies businesses for $3.3 billion last year.
    • “2025 was affected by headwinds consistent across the managed care industry associated with elevated utilization of healthcare services and higher acuity levels caused by more complex health needs across all of our lines of business,” an HCSC spokesperson told Becker’s.
    • “The company has 27.3 million members and managed $150.4 billion in medical spend in 2025.”
  • and
    • “Blue Cross and Blue Shield of Alabama posted a net loss of $3.2 million in 2025.
    • “The insurer saw its profit fall to $18 million in 2024 after posting $368.6 million in net income in 2023, according to financial data filed with the National Association of Insurance Commissioners.
    • “BCBS Alabama reported total assets of $6.2 billion at the end 2025, with capital and surplus of $3.6 billion. Medicare was the company’s largest line of business by direct premiums written at $1.5 billion, followed by the Federal Employees Health Benefits program at $1.2 billion, Medicare supplement at $207.7 million, dental at $158.7 million, and vision at $15 million.”
  • and
    • “Blue Cross Blue Shield of Arizona recorded a net loss of $335.2 million in 2025, according to regulatory filings.
    • “The insurer posted a loss of $162.2 million in 2024 and $85.4 million in net income in 2023.
    • BCBS Arizona reported total assets of $2.68 billion as of year-end 2025, with capital and surplus of $1.03 billion. The Federal Employees Health Benefits program was the company’s largest line of business by direct premiums written at $1.02 billion, followed by dental at $193.6 million, Medicare supplement at $27.9 million, and Medicare at $5.1 million.”
  • Healthcare Dive adds,
    • “Centene raised its 2026 profit guidance after successfully wrestling down medical costs in the first quarter.
    • “The St. Louis-based payer posted adjusted earnings per share of $3.37 in the quarter, well above analysts’ consensus expectations of about $2.20 to $2.30 as rate hikes offset membership losses.
    • “Companies generally argue that adjusted results are a better indicator of a company’s performance, as they exclude factors outside of a company’s control. But even when filtered through the U.S.’ default accounting standards, or unadjusted, Centene’s top and bottom-line results remained positive.
    • “In the first quarter, the insurer brought in net profit of $1.5 billion, up 18% year over year, on revenue of $49.9 billion, up 7% year over year.”
  • BioPharma Dive relates,
    • “Pfizer has reached settlements with a trio of drug manufacturers that’ll extend the patent protection for one of its best-selling medicines.
    • “In a short statement Tuesday, Pfizer said it has cut deals with Dexcel Pharma, Hikma Pharmaceuticals and Cipla. All three companies are seeking to launch generic versions of tafamidis, the active ingredient in a blockbuster rare disease medicine Pfizer sells as Vyndamax. Pfizer sued all for patent infringement, aiming to delay their arrival.  
    • “The agreements announced Monday ensure that tafamidis’ monopoly will hold until early next decade. Pfizer had anticipated that tafamidis’ exclusivity might expire in 2028 and prepared investors for a “significant decline” in U.S. revenues over the next few years. The settlement, though, extends tafamidis’ patent life through June 1, 2031, pending the outcome of other litigation. Drug sales in the U.S. should now “remain relatively stable” from 2028 through the middle of 2031, the company said.” 
  • Fierce Healthcare points out,
    • “Solace Health, a patient advocacy platform, is expanding insurance coverage to most major health plans, including UnitedHealthcare and Anthem Blue Cross Blue Shield. 
    • “Solace previously connected Medicare and Medicare Advantage patients to its services, which are now also available to many commercially insured patients. Other commercial plans that are now partners were not specified in a press release. Solace pairs each patient with a dedicated healthcare advocate who helps with care navigation.
    • “The healthcare system is complex and yet patients are often expected to coordinate their own care, interpret advice, manage records and resolve billing issues. One 2025 study found that over 60% of U.S. adults demonstrated inadequate health literacy. Solace aims to close this gap.”
  • and
    • “While some healthcare companies are testing out agentic AI tools, CCS is betting big on the technology as it developed an enterprise-wide, multi-agent network across its chronic care operations.
    • “The company, a provider of chronic care management and home-delivered medical supplies, has rolled out an agentic AI solution, dubbed CeeCee, that’s designed to streamline the patient experience, improve medical supply workflows and boost operational efficiency, executives said.
    • “CeeCee can autonomously resolve routine patient interactions, speed up access to chronic care supplies and support personalized patient experiences.” 
  • MedCity News adds,
    • “Issues with deployment and scaling are the real barriers holding back healthcare AI from delivering value, according to leaders at AI companies Nvidia and Hoppr.
    • “That’s why they’re shifting their focus away from building standalone models and zeroing in on the infrastructure needed for those models to actually be used in clinical practice. Hoppr has built an AI foundry that uses Nvidia’s computing and foundation models — an offering the partners say gives developers access to tools for launching medical imaging AI more easily at scale.
    • “The foundry aims to help providers develop, validate and then deploy their own AI models without having to start from scratch, said Hoppr CEO Khan Siddiqui.
    • We’re providing the platform where health systems, radiology practices and med device companies can now build their fine-tuned models very quickly and deploy them very quickly in their practice or in their product,” he explained.
    • “Hospitals no longer need huge amounts of data or infrastructure to create their own models because Hoppr and Nvidia pre-train their foundation models on massive datasets, he pointed out. In the past, providers needed to purchase massive datasets containing about 100,000 patient records to train AI models, but pre-trained foundation models allow hospitals to shape models using much smaller datasets, sometimes containing just hundreds of records, Siddiqui stated.
    • “The foundry’s goal is to make custom, localized AI development more feasible for providers, he declared.
    • “The focus is on increasing imaging AI models so that providers can embed specialized tools directly into radiology and diagnostic workflows rather than relying on one-size-fits-all solutions, Siddiqui noted.”

Monday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Noteworthy Death

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

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • The House Ways and Means Committee will hold a hearing with health system CEOs on April 28, 2026, at 10 am ET.
  • Roll Call offers more details on this week’s activities on Capitol Hill.
  • Federal News Network interviews NARFE Staff Vice President John Hatton about OPM’s ill-advised health claims data warehouse and the Postal Service’s decision to suspend making contributions toward their employee’s retirement benefits due to its cash woes.

From the public health and medical / Rx research front,

  • Health Exec reports,
    • “The more you maintain good physical fitness from your mid-40s to your mid-60s, the likelier you are to add years to your life and life to your later years. 
    • “So conclude researchers at Texas Tech University Health Sciences Center who tracked cardiorespiratory health in around 25,000 adults from midlife through elder stages. 
    • “The team, led by Clare Meernik, PhD, MPH, assessed participants’ fitness using a treadmill test until age 65. From that point on, the researchers used Medicare data to watch for and record the onset of 11 major chronic conditions such as heart disease, diabetes, kidney disease and cancer.
    • “The Journal of the American College of Cardiology published the results April 21.”
  • The FEHBlog noted on Friday that tick bites are increasing in the U.S. The Washington Post offers relevant advice. “Experts explained what to do if you find a tick attached to your skin, including how to remove it and document it, and when to seek medical advice.”
  • Building on another FEHBlog post from Friday, the Wall Street Journal explains what heart valve patients need to know before treatment.
  • Cardiovascular Business adds,
    • “New-onset postoperative atrial fibrillation (POAF) remains the most common complication following cardiac surgery, typically developing within four days of treatment. While it often resolves on its own, POAF is also associated with longer hospitalizations, higher healthcare costs and an increased risk of poor clinical outcomes, including long-term mortality.
    • “How can care teams work to minimize a patient’s risk of developing POAF? What is the best way to manage POAF once it develops? To answer those very questions, the Society of Thoracic Surgeons (STS) gathered a committee of cardiac surgeons, cardiologists, anesthesiologists and intensivists who specialize in POAF. The group reviewed years of data, including randomized trials and contemporary treatment guidelines, and landed on a total of 15 recommendations for reducing the risk of POAF after cardiac surgery. This included eight preventive strategies, three intraoperative techniques and four postoperative treatments.
    • “The committee’s report, first presented at the STS annual meeting in New Orleans, is now published in full in The Annals of Thoracic Surgery.

From the U.S. healthcare business front

  • Health Exec kindly offers five reasons not to (solely) blame insurance companies for what ails US healthcare.
    • High health insurance premiums are largely driven by high underlying healthcare costs. 
    • Health insurers don’t raise premiums to be mean, greedy or otherwise uncaring. 
    • As a share of premium revenues, health insurers’ profit margins are generally modest.
    • Prior authorization: A necessary ‘evil’ without which things would be worse. 
    • There’s enough blame to go around. 
  • Health Exec reports,
    • “TV viewers of a certain age have a hard time avoiding commercials hawking pharmaceutical and medical products. That category is the second-most heavily advertised on TV. Only entertainment is ahead of it. 
    • “And that’s just TV. Across all media, pharmaceutical companies are spending close to $10 billion per year on direct-to-consumer advertising in the U.S., MediaRadar reports. Only the entertainment industry spends more. 
    • “This kind of drug-pushing is legal, of course. But is it good for the health status of Americans?
    • “There are two schools of thought on that question. One defends a soft yes, the other a hard no. Both get a hearing in a slice of investigative journalism from KFF Health News in partnership with The New York Times.”
  • MedCity News notes
    • “Regeneron Pharmaceuticals’ Otarmeni is now approved for treating hearing loss from an ultra-rare genetic mutation found in an estimated 50 newborns per year. While Regeneron will offer this gene therapy for free, the approval came with a rare pediatric disease priority review voucher that the company can sell for hundreds of millions of dollars.”

Friday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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