Midweek update

CMS

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.”

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.”

Thursday report

David Ermer–ACA, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News reports,
    • “The Senate April 23 adopted a budget resolution by a 50-48 vote, paving the way for a narrow reconciliation bill focused on immigration enforcement funding. Congressional Republicans are seeking to use the reconciliation process primarily to end the partial shutdown of the Department of Homeland Security. The resolution instructs the Senate Homeland Security and Governmental Affairs Committee, the Senate Judiciary Committee, and the House Homeland Security and Judiciary committees to write legislation by May 15 that provides up to $70 billion in funding.  
    • “The vote followed a lengthy “vote-a-rama” session overnight that consisted of multiple proposed amendments from Democrats that failed to pass. Both chambers must pass a common budget resolution to move forward with the reconciliation process. Legislative action is expected in the House as early as next week.”  
  • STAT News reports,
    • “President Donald Trump’s acting attorney general on Thursday signed an order reclassifying state-licensed medical marijuana as a less-dangerous drug, a major policy shift long sought by advocates who said cannabis should never have been treated like heroin by the federal government.
    • “The order signed by Todd Blanche does not legalize marijuana for medical or recreational use under federal law. But it does change the way it’s regulated, shifting licensed medical marijuana from Schedule I — reserved for drugs without medical use and with high potential for abuse — to the less strictly regulated Schedule III. It also gives licensed medical marijuana operators a major tax break and eases some barriers to researching cannabis.
    • “The Trump administration also said it was jump-starting the process for reclassifying marijuana more broadly, setting a hearing to begin in late June.”
  • The Wall Street Journal tells us “What to Know About the Health Risks of Marijuana.”
    • “Studies show the drug can exacerbate anxiety and teen use poses risks for developing brains.”
  • STAT News adds,
    • “President Trump heralded a drug pricing agreement with Regeneron on Thursday, closing the last of 17 deals initially sought by the White House last year.
    • “Regeneron, as part of the private deal, will reduce prices on drugs to Medicaid, provide cholesterol medicine Praluent on TrumpRx for $225, and invest $27 billion in drug development in the United States.”
  • Tammy Flanagan, writing in Govexec, lets us know,
    • “I was planning to write about the number of TSP millionaires for this week’s column — until I started getting messages from former federal employees, all who retired on September 30, 2025, and are still waiting for their retirement benefit from the Office of Personnel Management (OPM) to be finalized.
    • “It is not completely surprising that retirement processing has slowed down, and for some former employees, they continue to wait for their retirement benefits to be finalized. But for the employees who have reached out for assistance, many have not received any money since their last paycheck was received in October 2025.
    • “It has been almost six months with very little or, in some cases, no money and little communication to help them understand how long they will have to continue to wait.” * * *
    • “In my experience, retirement processing is less like flipping a switch and more like closing out a file with dozens of tabs. One missing document or unresolved question can stop forward progress.
    • “Common culprits include late or incomplete payroll certifications, missing service history, unposted deposits or redeposits for prior service, unresolved military service credit, periods of leave without pay that need to be documented, name discrepancies, incomplete beneficiary or survivor elections, or court orders that require special handling.
    • “None of these problems are rare, and when thousands of cases arrive at once, the odds go up that more people land in the exception pile.”
    • Tammy then make suggestion on steps to take.

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices.
    • “The pathway, called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, allows the two health agencies to work together, and with companies, during the device review process to speed up Medicare coverage for certain FDA-designated Class II and Class III breakthrough medical devices.
    • “The approach could enable Medicare national coverage and payment as soon as two months after a device has received market authorization, compared with approximately one year or more under the current system, according to the Thursday announcement.”
  • The Wall Street Journal relates,
    • “Children born deaf because of a rare condition can now take a drug to restore their hearing after a gene therapy was approved in the U.S., ushering in a new era for the treatment of an inherited form of hearing loss. 
    • “The Food and Drug Administration approved Regeneron Pharmaceuticals’drug Otarmeni for children born with a faulty gene that plays a role in hearing. It targets a rare condition affecting an estimated 20 to 50 newborns in the U.S. each year and could eventually be expanded to an even wider population if additional studies succeed.
    • “In my wildest dreams I never thought we’d be here in my lifetime,” said Lawrence Lustig, a hearing specialist at Columbia University Irving Medical Center who helped lead the trial.
    • “Regeneron said it would offer the drug free to people in the U.S.”
  • MedTech Dive tells us,
    • “Tandem Diabetes Care issued an urgent medical device correction for a software problem with its Mobi insulin pumps.
    • “The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. 
    • “Tandem sent a letter to customers in October notifying them of the fault and instructing them to update their pump software as soon as possible. Tandem had reported four serious injuries related to the problem as of Nov. 4.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Federal Trade Commission has reached an agreement in principle with U.S. Anesthesia Partners to settle the government’s 2023 lawsuit. 
    • “The terms of the preliminary settlement are confidential so USAP can carry out the negotiations necessary to fulfill them, the FTC said in a Thursday news release.
    • “The agency in its original complaint claimed the anesthesiology group allegedly violated antitrust laws and reduced competition for anesthesia services in Texas. The preliminary settlement resolves the charges, the FTC said Thursday.” 
  • The New York Times points out “A $440,000 Breast Reduction: How Doctors Cashed In on a Consumer Protection Law.”
    • A law meant to end surprise medical billing accidentally created a multibillion-dollar industry that is making doctors richer.”
  • FEHBlog observation – This is happening. Why can’t Congress and the regulators fix the problem?

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk will seek regulatory approval for its semaglutide pill to treat Type 2 diabetes in children and adolescents after a late-stage trial showed it significantly reduced blood sugar in 10- to 17-year-olds.
    • “The once-daily semaglutide pill is currently marketed as Rybelsus in the EU and U.S. to treat diabetes in adults and will be available in the U.S. as Ozempic pill later in the second quarter. It is not currently approved for use in children or adolescents.
    • “The Danish drugmaker said Thursday that oral semaglutide has the potential to be the first oral GLP-1 to demonstrate a superior reduction in blood sugar levels compared with a placebo in children and adolescents with Type 2 diabetes, while maintaining the well-tolerated safety profile seen across other semaglutide trials.
    • “Over the past two decades, the prevalence of Type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need,” said Martin Holst Lange, Novo Nordisk’s chief scientific officer and head of research & development.”
  • MedPage Today relates,
    • “An investigational benzamide antipsychotic significantly improved symptoms in hospitalized adults with acute schizophrenia in a phase II trial.
    • “The drug, N-methyl amisulpride, is similar to its predecessor, amisulpride, but has some key differences in dosing and side effects.
    • “Because of the 4-week trial duration, long-term treatment durability wasn’t evaluated.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Diabetes affects over half a billion people globally. Along with direct consequences to those with the disease, it also contributes to and predisposes affected individuals to a host of other conditions. Specifically, it is a known contributing factor in the development of vascular disease, including peripheral artery disease. While therapies exist, they are not very effective, and peripheral artery disease can lead to restricted blood flow in peripheral limbs, which sometimes leads to amputation. Understanding the mechanism driving the connection at the tissue and cellular level has the potential to improve therapy options and the development of new treatments.
    • “Normal function of the peripheral vasculature requires communication and cooperation between the vascular endothelium and macrophages. “Monocytes patrol the vascular endothelium and remove damaged cells, and intimal-resident macrophages maintain a nonthrombogenic endothelial state,” wrote the authors of a study led by Zhen Chen, PhD, at City of Hope. They explained that under stress, macrophages can modulate vascular remodeling and in certain conditions, like cancer, they “can secrete inflammatory mediators to disrupt endothelial cell tight junctions and increase endothelial cell permeability.”
    • “The team decided to explore the cellular cross-talk between macrophages and endothelial cells, as well as the resulting vascular function, to better understand the mechanisms behind peripheral artery disease induced by diabetes.
    • “They published their work in a paper titled “Diabetes-induced TREM2–endothelial cell signaling impairs ischemic vascular repair” in Science Translational Medicine.“
  • Healio tells us,
    • “Influenza vaccination continues to protect children from influenza-related outpatient visits and hospitalizations, according to post-pandemic data published in Pediatrics.
    • “We have had really severe recent seasons for flu, particularly in children,” Samantha M. Olson, MPH, an epidemiologist in the CDC’s influenza division, told Healio in an interview. “This study really adds to the growing body of evidence showing how protective flu vaccines can be for infants, children and adolescents, and this includes even the most severe outcomes.”
  • and
    • “People taking GLP-1s had reduced risk for atrial fibrillation, regardless of whether they lost weight or how much they lost, according to findings presented at Heart Rhythm 2026.
    • “We were prompted to undertake this study by some encouraging data that … GLP-1 receptor agonists seem to have a favorable effect on reducing the incidence of atrial fibrillation, particularly in patients with metabolic risk factors,” Kenneth C. Bilchick, MD, MS, professor of cardiovascular medicine at the University of Virginia School of Medicine, who presented the findings, told Healio. “I think the results were expected, but they were even better than we thought they would be.”
  • Health Day informs us,
    • For many women, a sudden sneeze or a hearty laugh bring an unwelcome consequence: A small leak of urine. 
      Often dismissed as a normal part of aging or motherhood, new research suggests the real culprit may lie deep within the abdomen.
      A study from the Federal University of São Carlos (UFSCar) in Brazil found that hidden fat stored between internal organs is a major driver of stress-induced urinary incontinence.
      The research — published recently in the European Journal of Obstetrics & Gynecology and Reproductive Biology — suggests that where a woman carries her weight matters far more than the number on the scale.
      Stress urinary incontinence occurs when everyday actions like coughing, lifting or exercising put too much pressure on the bladder, causing urine to leak.
      “It’s that urinary leakage that occurs when pressure inside the abdomen increases and the pelvic floor can’t hold it in,” Patricia Driusso said in a news release. She’s a professor of physical therapy at UFSCar.

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

  • Healthcare Dive reports,
    • “Molina benefited from better controlled Medicaid spending in the first quarter, though steeper membership losses than expected raise questions about whether the insurer can keep costs in hand for the remainder of 2026.
    • “Molina posted better-than-expected first quarter earnings on Wednesday afternoon, sending the insurer’s stock up more than 10% in Thursday morning’s trade.
    • “Yet, unlike its peers UnitedHealth and Elevance, which both raised 2026 guidance after keeping medical spending in check, Molina elected to reaffirm its outlook.
    • “Executives said retaining the current 2026 guidance is prudent given it’s early in the year and the cost environment remains challenging. Still, they hinted Molina might update the outlook after the second quarter.”
  • Fierce Healthcare relates,
    • “Elevance Health’s top brass told investors Wednesday that the insurer is on pace to end the second quarter of 2026 with about 1.2 million members in its individual market plans.
    • “CEO Gail Boudreaux said on the company’s earnings call that the company saw “moderately stronger retention” in the Affordable Care Act segment through Q1, and that it was one of the contributing factors to its better-than-expected results in the quarter.
    • “The membership growth in the individual market plans reflected a shift toward bronze tier coverage following the expiration of enhanced premium tax credits at the beginning of this year, said Chief Financial Officer Mark Kaye. Part of why this trend contributed to lower medical costs is that utilization in these plans is frequently backloaded, he said.” * * *
    • “Kaye said that the company feels good about its position in the ACA market, and the shift to bronze tier plans has been positive in certain markets. However, the company is still taking a prudent approach to forecasting around the ACA market.”
  • Beckers Hospital Review identifies “eight health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2026.”
  • MedTech Dive tells us,
    • “Boston Scientific slashed its 2026 sales growth and earnings guidance on Wednesday as key businesses are facing challenges and setbacks.
    • “The medtech company expects full-year sales growth in a range of 7% to 8.5%, down from a range of 10.5% to 11.5% given in February. Boston Scientific also lowered its adjusted earnings per share guidance from a range of $3.43 to $3.49 to a range of $3.34 to $3.41.
    • “CEO Mike Mahoney told investors on an earnings call that the lowered guidance reflects challenges in several prominent businesses, including electrophysiology and the company’s Watchman franchise.
    • “This was a guide down that we, quite frankly, are not proud of, but we think it’s the right thing to do, and best reflects the current environment,” Mahoney said.”
  • Beckers Health IT informs us,
    • “OpenAI has introduced ChatGPT for Clinicians, offering free use of the tool to all verified U.S. physicians, nurse practitioners, physician assistants and pharmacists.
    • Here are [four] things to know from an April 22 news release and past Becker’s reporting:
      • “1. The AI developer said the solution can help clinicians with tasks like documentation, writing and medical research, freeing up time for patient care.
      • “2. OpenAI has previously launched ChatGPT for Healthcare, an enterprise solution for health systems, and ChatGPT for Health, a tool for users to ask health-related questions.
      • “3. The company also debuted HealthBench Professional⁠, a benchmarking application for three use cases: care consultation, documentation and writing, and medical research.
      • “4. OpenAI said its physician advisors review the AI’s healthcare responses “every few minutes” and before releasing ChatGPT for Clinicians tested nearly 7,000 conversations in their daily work, rating 99.6% of responses as accurate and safe.”
  • Healthcare Dive adds,
    • “The American Medical Association is urging Congress to create safety guardrails for artificial chatbots in mental healthcare, as Americans increasingly turn to the technology for health information and advice. 
    • “In letters sent Wednesday to the chairs of three congressional committees on digital health and AI, the major physician lobby said “well-designed, purpose-built” tools could help patients who would otherwise struggle to access mental healthcare, but that the lack of safety protocols poses serious risks.
    • “Privacy concerns, risks of emotional dependency on AI and reports the tools could encourage self-harm signal that “immediate attention is required to ensure these tools do not inadvertently harm individuals seeking mental health support or companionship,” AMA CEO Dr. John Whyte wrote.”

Tuesday report

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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