Friday Report

NIH

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “President Trump today released his discretionary spending budget blueprint for fiscal year 2026. The “skinny budget” request, which includes top line discretionary funding priorities, is not binding but can act as a starting point for Congress and the administration as they begin the appropriations process to fund the government. The administration later this month is expected to issue its full budget request, which will include its proposed changes to mandatory spending and tax policy.”  
  • Bloomberg Law adds,
    • “The president’s [skinny] budget calls for $557 billion in non-defense spending next year, which represents a cut of $163 billion from current levels. National security funding would increase to $1.01 trillion, a 13% increase from the previous year. Any final spending plan for regular agency budgets will need some Democratic support to pass the Senate, one of the few opportunities the minority party has to exert some leverage while Republicans have unified control over the federal government.”
  • Federal News Network informs us,
    • “Amid the Trump administration’s sweeping overhaul of the federal workforce, the Office of Personnel Management has shuttered an office that was central to developing leadership skills governmentwide.
    • “The Center for Leadership Development (CLD), an arm within OPM’s Human Resources Solutions (HRS) office, was bulldozed as part of an OPM reduction in force (RIF) in April. Federal News Network confirmed the elimination of the office with OPM, as well as two sources who provided further information on the condition of anonymity for fear of professional retribution.
    • “About 140 employees were working in the CLD office back in January, but those numbers had dwindled to about 80 employees over the last few months, according to an OPM employee familiar with the situation. Many CLD employees opted into the deferred resignation program (DRP) or voluntarily left their jobs. OPM notified the remaining employees on April 18 that their positions were being eliminated as part of the agency’s RIF.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Novo Nordisk NOVO.B said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on the market.
    • “The Bagsvaerd, Denmark, company said Friday that if the application is approved, Wegovy would become the first oral formulation of a GLP-1 drug for chronic weight management.
    • “The FDA’s deadline to decide on the application will be in the fourth quarter, the company said.
    • “The application is based on results from a phase 3 randomized, controlled trial evaluating the efficacy and safety of the drug over 64 weeks, the company said.”
  • Per a National Cancer Institute news release,
    • “The Food and Drug Administration (FDA) has approved the combination of two immunotherapy drugs for the initial treatment of some people with advanced colorectal cancer. The approval is for the use of nivolumab (Opdivo) and ipilimumab (Yervoy) for people whose tumors are classified as MSI-H or dMMR.
    • “About 5% of people with advanced colorectal cancer have MSI-H or dMMR tumors, which means the tumors are unable to properly repair certain types of DNA damage that can occur during cell division. Several colorectal cancer experts said the approval should immediately make the combination the preferred initial, or first-line, treatment for people with advanced MSI-H or dMMR colorectal cancer. 
    • “The approval was based on updated findings from a large clinical trial, called CheckMate-8HW in which all participants had advanced colorectal cancer with MSI-H or dMMR tumors. Patients in the trial who were treated with the combination of nivolumab and ipilimumab lived substantially longer without their cancer getting worse, a measure known as progression-free survival, than patients treated with nivolumab alone.”
  • Modern Healthcare reports,
    • GE HealthCare said Friday it received Food and Drug Administration clearance for its artificial intelligence tool that uses deep learning to outline organs at risk in MRI images and help improve radiation therapy planning.
    • MR Contour DL can outline 37 organs and structures in the head-neck and pelvic areas. The process previously had to be done manually.
    • The AI model will be integrated into the company’s Intelligent RT radiation therapy workflow management solution, which provides clinicians with a real-time view of a patient’s radiation therapy treatment journey.
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS). 
    • “This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
    • “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
  • MedTech Dive adds,
    • “Intuitive Surgical received Food and Drug Administration clearance for its da Vinci Single Port surgical system for procedures performed through the anus.
    • “The clearance covers the use of the system for transanal local excision/resection, enabling physicians to reach lesions in the upper rectum without cutting the abdomen, according to the Thursday announcement. Conventional transabdominal rectal resection can require multiple incisions and the removal of the rectum. 
    • “Intuitive designed the single port device to navigate narrow body cavities. Physicians can control up to three multi-jointed instruments and a camera through a single entry point.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • “RSV
      • “RSV activity continues to decline in most areas of the country.
    • “Vaccination
      • “Vaccination coverage with influenza, COVID-19, and RSV vaccines remained low among U.S. adults and children during the 2024─25 respiratory virus illness season.”
  • Per the AHA News,
    • “The U.S. has had 935 confirmed cases of measles so far this year, according to the latest data from the Centers for Disease Control and Prevention. Cases have been reported by 29 states, with Texas reporting the most at 683 — a 20% increase from last week. There have been 12 outbreaks, and 93% of confirmed cases (869 of 935) are outbreak-associated. The vaccination status of 96% of all cases is classified as “unvaccinated or unknown.”
  • The University of Minnesota’s CIDRAP adds,
    • “The nation is now experiencing 12 [measles] outbreaks, one more than the previous week, and 93% of illnesses reported are connected to outbreaks.
    • “In related developments, CBS News reported yesterday that Health and Human Services Secretary Robert F. Kennedy Jr. would ask the CDC to develop new guidance for treating measles with drugs and vitamins. Today, the CDC posted new resources for public health departments and parents, along with a fact sheet for clinicians that covers two alternative treatments that Kennedy has pushed, including vitamin A, antibiotics, and inhaled steroids.”
  • and
    • “Twelve more US children have died of influenza, surpassing theprevious high for a flu season outside of a pandemic year, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.
    • “The pediatric deaths push the season total to 216, surpassing last season’s total of 207. Ten of the children died of influenza A, and two died from influenza B. Subtyping showed that eight of the influenza A deaths were caused by the H1N1 strain, and four were H3N2.”
  • CNN offers an interview with its wellness editor, who is an emergency medicine doctor, about whooping cough.
  • Per the University of Minnesota CIDRAP,
    • “A study published earlier this week in Nature Communications using claims data from the US Veterans Affairs (VA) Healthcare System finds protection from the 2024-25 Pfizer COVID-19 vaccine was 68%, 57%, and 56% against COVID-19–associated hospitalizations, emergency department and urgent care (ED/UC) visits, and outpatient visits, respectively.
    • “However, the authors caution that uptake of the vaccine was extremely low—only 3.7% through November 2024—and the study did not assess waning effectiveness.”
  • The New York Times reports,
    • The video is just under two and a half minutes long. A slim man with close-cropped hair walks into a room, pulls a long black mamba — whose venom can kill within an hour — from a crate and allows it to bite his left arm. Immediately after, he lets a taipan from Papua New Guinea bite his right arm. “Thanks for watching,” he calmly tells the camera, his left arm bleeding, and then exits.
    • Over nearly 18 years, the man, Tim Friede, 57, injected himself with more than 650 carefully calibrated, escalating doses of venom to build his immunity to 16 deadly snake species. He also allowed the snakes — mostly one at a time, but sometimes two, as in the video — to sink their sharp fangs into him about 200 times.
    • This bit of daredevilry (one name for it) may now help to solve a dire global health problem. More than 600 species of venomous snakes roam the earth, biting as many as 2.7 million people, killing about 120,000 people and maiming 400,000 others — numbers thought to be vast underestimates.
    • In Mr. Friede’s blood, scientists say they have identified antibodies that are capable of neutralizing the venom of multiple snake species, a step toward creating a universal antivenom, they reported on Friday in the journal Cell.
  • The AHA News notes, “Older adults may be in circumstances that exacerbate challenges to accessing behavioral health care and have complex needs that can complicate behavioral health treatment. This new infographic gives statistics about how behavioral health care needs change in an aging population.” 
  • Healio tells us,
    • “Once-weekly semaglutide 2.4 mg significantly reduced steatohepatitis and liver fibrosis symptoms among adults with metabolic dysfunction-associated steatohepatitis and moderate or advanced liver fibrosis, researchers reported.
    • “In findings from part one of the ESSENCE phase 3 trialpublished in The New England Journal of Medicine,semaglutide 2.4 mg (Wegovy, Novo Nordisk) conferred greater improvements in multiple liver endpoints compared with placebo. In addition to greater improvements in steatohepatitis and liver fibrosis, researchers also observed greater weight loss, reduced insulin resistance and improvement in noninvasive liver markers with the GLP-1 medication.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna is building on client demand for tools to support patients on GLP-1 weight loss drugs, announcing two new programs on Friday meant to improve clinical care around the dispensing of GLP-1s and provide home delivery of the medications.
    • “The programs come as payers that contract with Cigna’s massive pharmacy benefit manager Express Scripts for their drug benefits want to offer GLP-1s but are put off by the medications’ steep list prices and unpredictable long-term outcomes, according to Cigna.
    • “The programs were announced in tandem with Cigna’s first quarter results, which came in well above analysts’ expectations. Revenue of $65.5 billion was up more than 14% year over year, while net income of $1.3 billion compares to a loss of $277 million same time last year. Cigna raised its 2025 profit outlook following the results.”
  • and
    • “Amwell narrowed its losses on growing revenue in the first quarter as the telehealth vendor continued to roll out products as part of a contract with the Department of Defense.
    • “The company posted a net loss of $18.4 million, down from $73.4 million in the prior-year period. Amwell reported revenue of $66.8 million, compared with $59.5 million in the first quarter last year. 
    • “The telehealth firm has deployed scheduled virtual visits across the Military Health System, executives said in an earnings call Thursday. However, rollouts for its automated and digital behavioral health programs will take place in the third quarter instead of the second due to leadership changes at the Defense Health Agency, leaders said.”
  • Fierce Healthcare points out,
    • “UnitedHealth Group and Amedisys have found buyers for key divestitures aimed at getting their $3.3 billion merger over the finish line, according to new filings.
    • “In documents submitted to the Securities and Exchange Commission (SEC), Amedisys said April 30 the companies entered an agreement to sell off certain Amedisys home health and hospice centers, as well as some of UnitedHealth’s care centers, to BrightSpring Health Services and the Pennant Group.
    • “Completion of these sales is contingent on several factors, according to the filing, including the final closure of the UnitedHealth-Amedisys deal.
    • “Financial terms were not disclosed in Amedisys’ filing, but the Pennant Group noted in a separate SEC document that it would pay about $102.5 million for the assets it’s buying from Amedisys and UnitedHealth.”
  • Per Biopharma Dive,
    • “Amgen on Thursday said its just-launched biosimilar of Johnson & Johnson’s autoimmune drug Stelara recorded $150 million in sales in the first quarter, spotlighting rising revenue from the biotech’s portfolio of copycat biologics.
    • “During the company’s first quarter earnings call, commercial chief Murdo Gordon said Amgen’s biosimilar products recorded $735 million in sales, roughly 9% of the company’s revenues. Those sales climbed 35% compared to the same period last year, showing the business “continues to contribute meaningfully to our long-term growth,” CEO Robert Bradway said.
    • “Still, Amgen’s overall performance is uneven. While some products are thriving, like an Avastin lookalike that booked $179 million in sales, others, such as its Humira biosimilar are struggling. Amgen recently launched a biosimilar version of Regeneron’s eye drug Eylea and could begin marketing a copycat form of AstraZeneca’s rare disease treatment Soliris sometime before the middle of the summer.”
  • and
    • “Madrigal Pharmaceuticals said its pioneering medicine for a common liver disease brought in $137.3 million in the first quarter, surpassing analyst estimates by more than $20 million. 
    • “More than 17,000 patients have now taken the drug, known as Rezdiffra, Madrigal said Thursday. It won Food and Drug Administration approval in March 2024, becoming the first medication cleared to treat metabolic dysfunction-associated steatohepatitis, or MASH.
    • “The company said it’s now looking toward a potential mid-year approval that would position Rezdiffra as the first available MASH treatment in Europe. CEO Bill Sibold said he’s looking to build on what he described as an “exceptional launch” in the U.S.”
  • Fierce Pharma adds
    • “AstraZeneca has taken a key step in advancing Breztri Aerosphere toward a potential label expansion and achieving its goal of annual sales of $3 billion to $5 billion for the 3-in-1 inhaler.
    • “Two phase 3 trials evaluating the effectiveness and safety of Breztri in a total of 4,434 patients with uncontrolled asthma have met their primary endpoints. The studies showed that Breztri delivered statistically significant and clinically meaningful improvements in lung function compared to dual-drug combinations of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) maintenance treatments, AZ said.
    • “Data from the KALOS and LOGOS studies will be shared with regulatory authorities and presented at an upcoming medical meeting, the company added.”

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Medicare, NIH, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • The International Foundation of Employee Benefit Plans let us know,
    • Over a dozen bills that would amend the Internal Revenue Code of 1986 to expand health savings accounts (HSAs) have been introduced in Congress this year, according to the International Foundation’s [article]. If enacted, the bills aim to change the disadvantages of HSAs and/or high-deductible health plans (HDHPs) that make them inaccessible or undesirable to some people. If enacted, some bills would allow more people to own HSAs, contribute more annually, and use HSA dollars for more items and services. Other bills would change HDHPs to allow more than preventive services, such as chronic disease treatments, to be covered before the deductible.
  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, May 6, 2025, at 10:00 AM to consider James O’Neill to be Deputy Secretary of the Department of Health and Human Services (HHS) and Gary Andres to be an Assistant Secretary of HHS.”  
  • Beckers Payer Issues offers five notes on the Trump Administration’s approach to Medicare Advantage so far.
  • Modern Healthcare adds,
    • “Leaders at the Centers for Medicare and Medicaid Services are exploring proposals to limit health insurers’ use of tactics that can delay medical care, people familiar with the discussions said. 
    • “The aim of the proposals would be to cut the number of medical procedures subject to “prior authorization,” meaning ones in which doctors have to fill out additional paperwork for ultimate approval. CMS is exploring making policies more uniform across different health insurance plans. 
    • “Another goal is automating coverage determinations so patients can get decisions faster, said the people, who weren’t authorized to speak publicly on the matter. The discussions are in preliminary stages, and the agency’s direction could change.”
  • Modern Healthcare also shares some health insurer associations’ deregulatory ideas offered to the Trump Administration.
    • “The Coalition Against Surprise Medical Billing, which includes the health insurance trade group AHIP and the Blue Cross Blue Shield Association, wants CMS to make the No Surprises Act out-of-network billing dispute resolution process more favorable to their members, it wrote the White House, HHS, the Treasury Department and the Labor Department last Tuesday.
    • “The Alliance of Community Health Plans, which represents insurers affiliated with nonprofit health systems, wants CMS to nix a variety of quality and performance reporting requirements, including for defunct programs such as the Medicare Advantage Value-Based Insurance Design model, which CMS shut down last year.
    • “The association also wants CMS to ease rules regarding beneficiary communications, such as requiring them to opt into digital communications. These mandates are the “epitome of administrative burdens,” Alliance of Community Health Plans President and CEO Ceci Connelly wrote to CMS April 9.”
  • MedPage Today’s editor in chief interviews the new FDA Commissioner Marty Makary, MD, here.

From the judicial front,

  • STAT News reports,
    • “The Supreme Court on Tuesday rejected hospitals’ argument that the federal government doesn’t pay them enough for treating low-income patients [by a 7-2 majority].
    • “The seven-justice majority instead sided with the Department of Health and Human Services’ interpretation of the law concerning disproportionate share hospital, or DSH, payments, which compensate hospitals for treating low-income patients. More than 200 hospitals brought the case, Advocate Christ Medical Center v. Kennedy, arguing the federal agency’s misreading of the law causes it to underpay them by well over $1 billion each year.” 

From the public health and medical research front,

  • The National Institutes of Health (NIH) announced,
    • adopting a new initiative to expand innovative, human-based science while reducing animal use in research. Developing and using cutting-edge alternative nonanimal research models aligns with the U.S. Food and Drug Administration’s (FDA) recent initiative to reduce testing in animals. While traditional animal models continue to be vital to advancing scientific knowledge, using new and emerging technologies can offer unique strengths that, when utilized correctly or in combination, can expand the toolbox for researchers to answer previously difficult or unanswerable biomedical research questions.
    • “For decades, our biomedical research system has relied heavily on animal models. With this initiative, NIH is ushering in a new era of innovation,” said NIH Director Dr. Jay Bhattacharya. “By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted—from clinical development to real-world application. This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments. It marks a critical leap forward for science, public trust, and patient care.”
  • The current issue of NIH Research Matters covers the following topics: “Restoring speech after paralysis | CT scans and cancer risks | Visual information processing in the brain.”
  • Health Day tells us,
    • “A Kaiser Permanente colon cancer screening initiative put a huge dent in cancer cases and deaths over two decades, a new study says.
    • “The systematic outreach program doubled colon cancer screening rates, researchers are scheduled to report at the upcoming Digestive Disease Week meeting in San Diego.
    • “As a result, cancer cases were cut by a third and colon cancer deaths by half, researchers report.
    • “In addition, racial disparities in colon cancer outcomes nearly vanished as a result of the initiative, researchers said.
    • “By offering an effective screening approach equally to everyone, we were able to eliminate much of the disparity,” said lead investigator Dr. Douglas Corley, chief research officer with the Kaiser Permanente Division of Research in Northern California.
    • “Ten years ago, there were big gaps in cancer risk and death, especially among our Black patients,” he said in a news release. “Now, those differences are nearly gone.”
  • MedPage Today informs us,
    • “The addition of the pregnancy checkbox on death certificates in 2003 was responsible for most of the spike in maternal deaths since 2000.
    • “However, in 2021, adjusted maternal death rates peaked at 18.86 per 100,000 live births, in line with the COVID pandemic.
    • “Of note, both infant and fetal death rates per 1,000 live births declined across the study period.” * * *
    • “Our work is the first to quantitatively separate out the effect of change in data collection from actual trends in maternal mortality,” co-author Robin Park, MSc, also of the University of Oxford, told MedPage Today. “Adjusting for the change in data collection, we find that the rate of maternal mortality has been relatively constant since 2000.”
    • “Park noted that while the checkbox doesn’t change the definition of maternal death, “anecdotal evidence suggests that it makes coders more likely to add a maternal or pregnancy-related cause of death,” and thus it’s been difficult for researchers to “parse out the true trends from changes in data collection.”
  • Per MedTech Dive,
    • “Since its U.S. debut more than a year ago, pulsed field ablation continues to gain converts at a fast pace, with devices from Boston Scientific and Medtronic leading the way.
    • “The procedure is becoming physicians’ preferred ablation method for treating atrial fibrillation, an irregular rhythm that can lead to complications such as blood clots, stroke and heart failure. PFA delivers electrical pulses to targeted areas of the heart causing abnormal rhythms, offering a potentially safer approach than older treatments that use heat or extreme cold to ablate the tissue.
    • “In connection with the Heart Rhythm Society’s 2025 meeting in San Diego, which wrapped this weekend, Boston Scientific, Medtronic, Abbott and Johnson & Johnson all unveiled data supporting their devices.
    • “Truist analysts, in a note to clients Sunday, said physicians they spoke with at the event reported that the more efficient PFA procedures were allowing their institutions to perform at least 20% to 30% more cases.”

From the U.S. healthcare business front,

  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of tirzepatide (Zepbound®, Eli Lilly & Co.) and semaglutide (Wegovy®, Novo Nordisk) for the treatment of obesity. ICER will also assess how these treatments affect additional obesity-related outcomes.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“
  • The Wall Street Journal reports,
    • “AstraZeneca’s core EPS rose to $2.49, revenue increased 10% to $13.59B, but shares fell over 4% amid legal challenges in China.
    • “The company reaffirmed its 2025 targets after oncology revenue grew 13% to $5.64B, driven by Tagrisso and Imfinzi.
    • “China revenue rose 3%, but the company faces potential fines in the country over alleged illegal drug imports.”
  • and
    • “Hims & Hers partners with Novo Nordisk to offer Wegovy for weight loss, with subscriptions starting at $599 a month.
    • “The collaboration includes clinical support and nutrition guidance via Hims & Hers’ platform and NovoCare Pharmacy.
    • “Novo and Lilly are partnering with telehealth providers amid competition in the weight-loss drug market.”
  • and
    • “Merck is investing $1 billion in a Delaware plant to expand its U.S. manufacturing, amid potential tariff concerns.
    • “The plant will produce biologic drugs and a new, easier-to-use version of Keytruda, the company’s blockbuster cancer drug.
    • “The facility is Merck’s first in-house U.S. site for Keytruda, ensuring domestic supply and creating at least 500 on-site jobs.”
  • Per Healthcare Dive,
    • “Universal Health Services reported earnings for the first quarter on Monday evening that came in below Wall Street’s expectations for revenue. The for-profit’s behavioral health business also underperformed compared to its acute care service line.
    • “Behavioral health adjusted admissions declined by 1.6% compared to the prior year, while acute care admissions grew by 2.4%. Executives blamed the leap year in 2024 and atypical winter weather in some markets for depressed patient days, noting adolescent behavioral care utilization rates were particularly impacted by weather-related school closures. 
    • “CEO Marc Miller told investors during a Tuesday morning earnings call that UHS could get its behavioral health unit back on track to grow patient day revenue by 2.5% to 3% by the end of the year. However, the executive declined to specify when investors could expect to see improvement and dodged questions about whether volumes are expected to improve in the second quarter or the back half of the year.”
  • Per Fierce Healthcare,
    • “Though it opted to stick with annual guidance numbers given in February, Tenet Healthcare’s “outstanding” first-quarter performance has the company pushing ahead on growth initiatives in the face of financial headwinds and policy uncertainties.
    • “Tuesday morning, the hospital and ambulatory surgical center operator shared a $406 million net income attributable to the company ($4.27 per diluted share) for the first three months of the year. Net operating revenues decreased year over year from $5.4 billion to $5.2 billion, largely reflecting hospital divestitures during the prior year.
    • “Its adjusted EBITDA of $1.16 billion was up 14% over the same period a year prior and “well above the high end of our guidance range,” Chief Financial Officer Sun Park said Tuesday.
    • “Tenet CEO Saum Sutaria, M.D., told analysts that the earnings growth stems from divesting low-margin facilities and recent years’ focus on operating discipline. It’s set the stage for Tenet to continue focusing on labor structure and supply standardization, to increase its operating leverage and to build out its portfolio of well-performing assets.”
  • and
    • “Telehealth company LifeMD bought assets from Optimal Human Health MD to accelerate its push into the women’s health market.
    • “The acquisition establishes a scalable clinical and operational foundation for a comprehensive virtual health program, set to launch this summer, focused on hormone health, bone density, metabolism and long-term wellness. LifeMD’s virtual women’s health platform will target areas such as menopause and osteoporosis.
    • “The company did not disclose financial details of the acquisition.”
  • Modern Healthcare reports,
    • “Dr. Shawn Griffin, president and CEO of URAC, has had a front row seat to AI’s evolution in healthcare and he’s worried there are not enough guardrails.
    • “There is an urgent need for standards to be developed and quickly, given the change in presidential administrations, said Griffin, who six years ago became the first physician to lead the nonprofit accreditation organization for hospitals, health plans, telehealth providers, pharmacies and other healthcare players.”
    • “Looking at the way that AI was coming into healthcare, we recognized that there was a need for some sort of verifiable standards to be implemented to protect patients and to look out for their best interests in this area that’s moving so fast,” Griffin said. “It’s been on our radar screen for a few years.”
    • In the fall, URAC plans to launch a healthcare AI accreditation program, making it one of several organizations initiating these specific types of accreditation programs.

Monday Report

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Five months after announcing his esophageal cancer diagnosis, Virginia Rep. Gerald E. Connolly said Monday that he won’t seek a 10th term and also plans to step down as the top Democrat on the House Oversight and Government Reform Committee.
    • “The sun is setting on my time in public service,’’ Connolly, 75, said in a message to his constituents in Virginia’s 11th District. “With no rancor and a full heart, I move into this final chapter full of pride in what we’ve accomplished together over 30 years.” * * *
    • “Until his permanent successor on the committee is chosen, Connolly has asked Massachusetts Rep. Stephen F. Lynch to cover for him as the panel’s top Democrat, Politico reported Monday.”
    • Best wishes, Congressman.
  • STAT News tells us,
    • “In keeping with the Trump administration’s quest to slash spending at the federal health department, it’s hired a famously thrifty technology entrepreneur to lead Medicare. 
    • “As the CEO of health IT company Collective Medical, Chris Klomp flew bargain-priced Frontier Airlines and once boasted about sleeping in rental cars and crummy motels on business trips. The office snacks were from Costco. The penny-pinching didn’t stop after the bootstrapped company raised nearly $50 million from blue chip investors like Kleiner Perkins. One morning, Klomp arrived at the company’s headquarters just outside Salt Lake City, his 1960’s teal Ford pickup loaded full of printer paper that was on sale at Staples.” * * *
    • “Under Klomp’s watch, crucial decisions will be made about the direction of Medicare. They include whether to rein in abusive coding and denials practices by private Medicare Advantage plans that cover a majority of enrollees, whether to reform how Medicare pays doctors and hospitals, and whether it will pay for a new breed of obesity medications. Because of Medicare’s reach, other insurers often follow its lead on payments and other policies, putting Klomp in a position to significantly influence the entire American health care system.”
  • Healio adds,
    • “Medicare Part D coverage of obesity medications could lead to a large increase in health care costs due to the prices of the drugs, according to data from a microsimulation model published in JAMA Health Forum.
    • “As Healio previously reported, CMS decided to not move forward with a previously proposed rule to have Medicare begin covering obesity medications in the 2026 calendar year, though the agency said it could reconsider the proposal in future rulemaking.
    • “If Medicare were to cover obesity medications, however, there could be huge financial implications, according to David D. Kim, PhD, assistant professor of medicine and public health sciences at University of Chicago. 
    • “Our finding is that obesity drugs [would be] a pretty substantial cost, [about] $47 billion over the next 10 years,” Kim told Healio. “These are important numbers, because a lot of people say that GLP-1s will save a lot of money in health care because obesity is a risk factor for many other conditions. … Our paper highlighted that in some sense, GLP-1s do save money, but not enough to offset the high prices of the medication.”
  • BioPharma Dive lets us know,
    • “Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19 vaccine, saying Monday it believes its application is still approvable pending an agreement with the Food and Drug Administration on a postmarketing clinical trial.
    • “Last week, Novavax revealed the agency had requested what’s known as a postmarketing commitment to further study the shot in clinical tests. On Friday, The Wall Street Journal reported the FDA had asked Novavax to conduct an additional randomized clinical trial, which would be a costly and time-consuming additional step for the company.
    • “A spokesperson for Novavax, contacted by BioPharma Dive Friday, said the company “cannot comment on the details of the request” while engaging with the FDA. It’s unclear when exactly the agency wants Novavax to complete the study.”

From the judicial front,

  • Modern Healthcare reports,
    • “Elevance Health is facing a second lawsuit accusing it of maintaining inaccurate provider directories, also known as “ghost networks.”
    • The plaintiffs are three people covered under New York state employee health benefits who allege that Elevance Health division Carelon Behavioral Health misrepresented providers as in-network, causing them financial harm. The attorneys are seeking class-action status.” * * *
    • Pollock Cohen and Walden Macht Haran & Williams filed the lawsuit against Elevance Health subsidiary Anthem Blue and Cross Blue Shield of New York in the U.S. District Court for the Southern District of New York.
    • “The Elevance Health plaintiffs allege Carelon Behavioral Health, which administers mental health benefits to state and municipal employees enrolled in the New York State Health Insurance Program’s Empire Plan, misled policyholders seeking mental healthcare.”

From the public health and medical research front,

  • STAT News reports,
    • “A clinical trial run by the National Cancer Institute seems to confirm that a single dose of the vaccine used to prevent infection with the human papilloma virus is just as effective as two — and, therefore, also helps to prevent cancer.
    • “The result could transform efforts to reach the three-quarters of children globally who should receive the vaccines but don’t. The shots prevent cervical cancer and also anal, penile, and some head-and-neck cancers. Worldwide, 350,000 women die from cervical cancer, the most common HPV cancer.
    • “I think we can all agree that one dose and two doses of … these fantastic vaccines work really well,” said Aimée R. Kreimer, the NCI investigator who presented the new data here Monday at the annual meeting of the American Association for Cancer Research. “We’re really excited about these results.”
    • “In developed countries, including the U.S., two doses of the vaccines are currently recommended. But in the clinical trial, whether one dose or two doses were used, the results were equivalent, according to the study of 20,000 girls between ages 12 and 16 in Costa Rica who were followed for 4 1/2 years. In all cases, the estimated efficacy of the vaccines was upwards of 97%.”
  • Per MedPage Today,
    • “Another benefit of GLP-1 receptor agonist (RA) use may be protection from persistent atrial fibrillation (Afib or AF) after ablation, according to a large Veterans Affairs database.
    • “New initiators of these drugs in 2015-2022 — specifically people with type 2 diabetes (T2D), obesity, and active Afib — showed significant improvement in their time to first hospitalization for Afib, Afib-related procedures (cardioversion/ablation), or all-cause mortality over a median 3 years of follow-up (HR 0.87, 95% CI 0.68-0.96) when compared against controls getting a DPP-4 inhibitor (DPP4i) or sulfonylurea.
    • “Accounting for mortality as competing risk, the Afib burden trended numerically in favor of the GLP-1 RA group (HR 0.85, 95% CI 0.61-1.03), noted Varun Sundaram, MD, PhD, MSc, of Case Western Reserve University in Cleveland, in his presentation of the TRANSFORM-AF study at the Heart Rhythm Society annual meeting.
    • “This is an exciting study for people with AF, T2D, and obesity along with the clinicians treating them. This retrospective study suggests there is a cardioprotective effect of GLP-1RA compared to DPP4i in hard AF endpoints,” commented James Lo, MD, PhD, of Weill Cornell Medicine/New York-Presbyterian Hospital in New York City.
  • Medical News Today warns us,
    • “A multi-decade study finds that the damage done by smoking, heavy drinking, and being physically inactive begins at a far younger age than previously understood.
    • “Although the unwanted health consequences of these habits over the long term are well-known, the research offers evidence that their negative impact, though not as severe, actually occurs over the short term.
    • “Participants in the study were assessed for depression, sense of well-being, metabolic risk, and sense of healthfulness, all of which suffered as a result of smoking, drinking, and being inactive.
    • “While it is no surprise that a lifetime of smoking, heavy drinking, and physical inactivity is a recipe for ill health later in life. 
    • “Now, a new study finds that these habits can result in health issues as young as the age of 36, including their influence on mental health.
    • “The findings of the study were recently published in the Annals of Medicine.”
  • Health Day adds,
    • “Risk factors for dementia could start taking their toll as early as a person’s 20s and 30s, a new study says.
    • “Younger adults who carry known risks for dementia performed worse on memory and thinking tests between ages 24 and 44, researchers report in the May issue of the journal The Lancet: Regional Health Americas.
    • “The findings lay the groundwork for early detection of Alzheimer’s disease and dementia, researchers say.
    • “This is the first study to look at risk factors of dementia and Alzheimer’s disease in a large group of generally healthy younger adults, researchers say.
    • “Previously, research on Alzheimer’s disease risk factors has focused on individuals aged 50 and older,” lead researcher Allison Aiello, a professor of epidemiology at the Columbia University Aging Center, said in a news release.
    • “These new results show that well-established risk factors and blood biomarkers for dementia appear to start affecting cognitive function even before middle age, Aiello said.
    • “These risk factors include education level, gender, blood pressure, cholesterol, exercise and body mass index, a measure of body fat based on height and weight, results show. All these are measured using a Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score.”
  • The American Medical Association tells us what doctors wish their patients knew about insomnia.
  • Benefits Pro relates,
    • “According to researchers, the survey reveals a possible cognitive dissonance: Americans know they should schedule a preventive care screening or wellness visit, but their behavior often suggests otherwise. For 65% of Americans, experiencing a health scare is what made them realize they need to be more proactive about their health. Attitudes about preventive care are often counterintuitive, however, as many of those who believe they will be diagnosed with cancer are more likely to delay screenings (62% vs. 42%).
    • “Many avoid going to the doctor instead of doing what they can to avoid a health scare or detect a problem early,” Tom Morey, Aflac’s senior vice president and chief actuary, said in a statement while also noting his own health crisis that kept him away from work for nearly two years and in and out hospitals for 18 months. “It starts with making preventive care a priority and taking steps toward establishing a trusted relationship with a primary care doctor. Personally, this helped me to feel more confident, more in control of my health, and more empowered to deal with an illness that, otherwise, may have gone undetected.”
  • Health Day also informs us,
    • “Breast cancer patients fare better if they continue to exercise during their treatment, and a new program can help women get the activity they need to boost their odds, researchers say.
    • “The Comprehensive Oncology Rehabilitation and Exercise (CORE) program assesses women’s physical activity needs based on the stage to which their cancer has progressed, researchers reported today in the journal Cancer.
    • “More than 3 in 5 patients (62%) completed their referral to an exercise program designed to meet their specific needs, researchers said.
    • “CORE may serve as a model workflow algorithm aimed to integrate both exercise and rehabilitation services from time of diagnosis and beyond,” senior researcher Adriana Coletta, an investigator at the University of Utah’s Huntsman Cancer Institute, said in a news release.”
  • Consumer Reports, writing in the Washington Post, points out,
    • “You often hear that fish is brain food. True, but so are eggs, pork loin and Brussels sprouts. That’s because they’re rich in choline, a nutrient related to B vitamins.
    • “Choline is critically important for a variety of body and brain functions,” says Ramon Velazquez, an assistant professor at the Arizona State University-Banner Neurodegenerative Disease Research Center in Tempe. It’s part of all cell membranes, and in recent years there’s been increasing evidence linking it to better cognitive function and even a lower risk of Alzheimer’s disease. But about 90 percent of people don’t get enough of it.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Most Blue Cross and Blue Shield companies lost money last year as rising Medicaid and Medicare costs squeezed their bottom lines.
    • “The vast majority of 31 Blues companies reported weaker operating margins as membership declined and medical and pharmaceutical costs rose, according to an analysis of state financial filings that Mark Farrah Associates performed for Modern Healthcare.
    • “Across the Blues, operating margin fell 3.2 percentage points from a 0.3% gain in 2023 to a 2.9% loss in 2024. Just eight Blues companies reported positive operating margins last year.
    • “That contrasts with the annual margin growth enjoyed by national, publicly traded insurers. For-profit insurers average operating margin rose 1.6 percentage points to 2.4% in 2024, according to the health data analytics firm.”
  • Beckers Payer Issues tells us fifty things to know about UnitedHealth Group.
  • Fierce Healthcare relates,
    • “While health plans are not likely to feel the most acute effects from the Trump administration’s tariffs, they face downhill impacts from market volatility and rising costs, according to a new analysis from Fitch Ratings.
    • “The report examines the way tariffs could affect multiple types of insurance and estimates that health insurers in particular face moderate exposure to the slower economic growth and financial performance that are more indirect results of the tariffs.
    • “Health plans benefit in this particular case from the vast majority of their operations being domestic. However, while that suggests the impacts will be fairly limited in the short term, the effects would ramp up should the tariffs remain in place for an extended period, or if they evolve to be more restrictive.
    • “As an example, tariffs on pharmaceutical products would also likely lead to short-term cost pressures on insurers, according to Fitch.”
  • FiercePharma notes,
    • “Ending a 20-year-plus drought, Merck & Co.’s Keytruda demonstrated that its use around surgery can reduce the risk of certain head and neck cancers from returning.
    • “Continuous use of Keytruda—both before and after surgery—reduced the risk of recurrence or death by 27% in patients with stage 3 or 4a, resected, locally advanced head and neck squamous cell carcinoma (HNSCC), according to results from the phase 3 Keynote-689 trial presented at the American Association for Cancer Research Annual Meeting 2025.
    • “In the study, Keytruda was added to postoperative radiotherapy with or without chemo. Investigators compared the perioperative Keytruda regimen with the sans-Keytruda standard treatment.
    • “Keynote-689 marks the first positive trial in more than two decades in resected locally advanced HNSCC, making Keytruda the first PD-1 inhibitor to mount such a benefit.”
  • Per BioPharma Dive,
    • “Merck KGaA has agreed to buy biotechnology company SpringWorks Therapeutics, announcing Monday a $3.9 billion deal after months of negotiations over an acquisition.
    • “The German pharmaceutical firm will pay $47 per SpringWorks share, a small premium to the stock’s closing price Friday but 17% higher than the $40.28 it closed at on Feb. 7, the last trading day before reports emerged of the companies’ discussions.
    • “SpringWorks has developed two drugs that are approved in the U.S. to treat rare tumors. Ogsiveo is cleared for adults with desmoid tumors, while Gomekli won the Food and Drug Administration’s OK in February for adults and children with neurofibromatosis type 1 who experience symptoms from a type of benign tumor.”
  • Per MedTech Dive,
    • “Medtronic has filed for Food and Drug Administration approval of its Hugo soft tissue robotic surgery system with a urologic indication, marking a major step in its bid to compete with Intuitive Surgical. The company said Saturday that it made the submission in the first quarter of 2025. 
    • “Medtronic also completed enrollment in hernia and benign gynecology studies and received approval to start a trial in oncologic gynecology procedures. The studies will support submissions for additional U.S. indications for the robot.
    • “Data from the company’s investigational device exemption study for the Hugo robot in urologic surgery, presented at the American Urological Association annual meeting, met the primary goals for safety and effectiveness, according to Medtronic.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, NIH, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy, M.D., R-La., today released a report detailing findings from an investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. As part of his investigation, Cassidy requested information from hospitals, Federally Qualified Health Centers, contract pharmacies and drug manufacturers.  
    • “Cassidy said the “investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients,” and the report outlines potential reforms needed to improve the program to better serve patients.   
    • “In a statement shared with media, AHA President and CEO Rick Pollack said, “The AHA appreciates Senator Cassidy’s leadership on 340B issues. As his report correctly observes, the 340B program was created to help hospitals reach more eligible patients and provide more comprehensive services. Even this investigation — which the report recognizes was ‘limited in scope’ given the variety of 340B hospitals across the country — demonstrates that hospitals use 340B savings to provide financial assistance to low-income patients and to maintain programs that enhance patient services and access to care. In short, 340B is vital in advancing health in communities across the country.”  
  • The President signed an executive order strengthening probationary periods in the federal civil service. Here’s a link to a fact sheet.
  • Govexec tells us, “Ex-feds launch websites to help unemployed civil servants find new jobs. Many federal employees are looking for positions outside of government following reductions in force and the Trump administration’s push for workers to take separation incentives.”
  • Per a Drug Enforcement Administration news release,
    • DEA’s National Prescription Drug Take Back Day is your chance to rid your medicine cabinet of unneeded and unwanted medications. Start your spring cleaning this year on April 26 by visiting a collection site near you.
    • Mark your calendar for this upcoming event! Participating drop-off sites will be open from 10 a.m. to 2 p.m. (local time) on Saturday, April 26. Collection sites are located around the country and will be collecting:
      • Tablets
      • Capsules
      • Patches
      • Other solid forms of prescription drugs.
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan for evaluating a measure regarding “Vision in Children Ages 6 Months to 5 Years: Screening.” The public comment deadline is May 21, 2025.
  • Per the AHA News,
    • “The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.”

From the judicial front,

  • Professor Katie Keith wrote an article in Health Affairs Forefront about the Kennedy v. Braidwood Management oral argument presented to the Supreme Court last Monday.
  • Fierce Pharma informs us,
    • “Halozyme is not holding back against Merck & Co. in the companies’ injectable Keytruda patent dispute, having now escalated a verbal warning into a lawsuit.
    • “In a lawsuit filed Thursday in a New Jersey federal court, Halozyme alleges that a proposed subcutaneous formulation of Merck’s popular cancer drug Keytruda infringes 15 of its patents.
    • “Those intellectual properties belong to a Halozyme patent family called Mdase, which covers a large group of modified human hyaluronidases. A hyaluronidase protein may allow for under-the-skin administration of otherwise intravenously infused drugs.
    • “Halozyme is seeking an injunction to block Merck’s planned commercialization of subcutaneous (SC) Keytruda, which is under FDA review with a decision expected by Sept. 23. The San Diego drug delivery expert is also asking for monetary relief and “an enhancement of damages,” because the alleged infringement is said to be willful, according to its complaint.
    • “Even though SC Keytruda has not reached the market, Merck opened itself to patent litigation after publicly laying out its intention to launch the product this year pending FDA approval.”

In State government news,

  • Mercer offers a roundup of selected state healthcare developments in the first quarter of 2025.

From the public health and medical research front,

  • CNN reports,
    • “The United States has seen progress in reducing certain cancer risks, as overall smoking rates remain on a decline. But for other risk factors, such as those tied to cervical cancer, there is room for improvement, according to a new American Cancer Society report.
    • “The prevalence of people smoking fell from about 14% in 2019 to 11% in 2023, according to the report published Wednesday in the journal Cancer Epidemiology, Biomarkers & Prevention. Cigarette smoking is known to significantly increase the risk of developing cancer. It’s estimated to cause about 1 out of every 3 cancer deaths in the US. * * *
    • “The prevalence of people being up-to-date on recommended cervical cancer screenings has dropped from 74.8% in 2019 to 73.4% in 2021 among ages 21 to 65, the report found, leaving more women at risk of not detecting disease early. The reported noted that the decrease is alarming as HPV vaccination rates have remained “statistically unchanged” in recent years. In 2023, 61.4% of adolescents ages 13 to 17 were up-to-date for the HPV vaccination series, similar to 61.7% in 2021 and up from 54.2% in 2019.
    • “HPV or human papillomavirus is a group of more than 150 viruses that can cause certain types of cancer. Spread primarily through sexual contact, most cases of HPV clear on their own within two years, but when the infection does not go away, health problems like cancer may occur – which is why preventing these infections with vaccination has been key.”
  • The National Cancer Institute announced,
    • “Researchers have discovered what appears to be a critical biological driver of the most common form of ovarian cancer. The discovery, they believe, could spearhead the development of approaches for finding ovarian cancer at its earliest stages or preventing the disease from taking hold in the first place.
    • “Multiple studies have shown that high-grade serous ovarian cancer arises from precancerous growths called serous tubal intraepithelial carcinoma (STIC) lesions in the fallopian tubes. These lesions can eventually travel into the ovaries and transform into full-blown tumors.
    • “In this new study, Lan Coffman, M.D., Ph.D., of the University of Pittsburgh School of Medicine, and her colleagues showed that STIC lesions appear to arise and turn into tumors in the ovaries with the assistance of a type of stem cell that they called high-risk mesenchymal stem cells (MSCs).
    • “These high-risk MSCs—which have specific characteristics that appear to help their cancer-fueling capabilities—were abundant in the tissue, or stroma, immediately underneath STIC lesionsExit Disclaimer in fallopian tube tissue samples from women without cancer. They were also sometimes present in normal tissue. 
    • “When the researchers implanted high-risk MSCs along with healthy fallopian tube cells into mice, some developed ovarian cancer, including, in some cases, metastatic cancer, the researchers reported March 14 in Cancer Discovery.
    • “It’s not yet clear if high-risk MSCs are the primary instigator that causes healthy fallopian cells to transform into high-grade serous ovarian cancer, Dr. Coffman said, but the group’s findings support the idea that these cells are intimately involved. 
    • “What we believe we’re seeing is that [high-risk MSCs] are a supportive ‘soil’ for cancer initiation,” she said.”
  • Beckers Hospital Review adds,
    • “Some early-onset colorectal cancers may be caused by exposure to a bacterial toxin within the first 10 years of life, according to a study published April 23 in Nature.
    • “An international research team, led by Ludmil Alexandrov, PhD, from the University of California San Diego, analyzed 981 colorectal cancer genomes from patients across 11 countries for the study.” 
  • STAT News points out “Studies zoom in on clues to why Lyme disease persists and which antibiotic to prescribe. Cellular debris lingering in the liver and and a penicillin relative are identified.”
  • The AHA News tells us,
    • “A study published April 8 by the Public Library of Science’s Journal of Global Public Health found that driving while infected with COVID-19 raises the risk of an accident by 25%. The study analyzed public health and transportation data from seven states from 2020-2023. The results showed a significant association between acute COVID-19 infections and an increase in vehicle crashes.”
  • The Wall Street Journal reports,
    • A new study by French researchers found that some combinations of food additives were associated with a higher risk of Type 2 diabetes.
    • Researchers found that combinations of emulsifiers, colors and sweeteners increased the diabetes risk beyond what could be explained by individual substances alone.
    • Food-industry representatives defended combinations of what they said were safe ingredients, which they said are important for food safety and quality.
  • WTW notes, “Therapeutic alliance, the bond between client and therapist, is a game-changer in mental health programs. Employers must focus on measuring to predict better results and reduce dropout rates.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck’s first-quarter net income increased, driven by Keytruda sales, reaching $5.08 billion, or $2.01 a share, up from $4.76 billion year-over-year.
    • Despite sales of Keytruda rising 4% to $7.2 billion, Merck cut its 2025 adjusted earnings projection, citing tariffs and a license agreement.
    • Sales of HPV vaccine Gardasil fell 41% due to lower Chinese demand, while animal-health product sales rose 5% to $1.6 billion.
  • and
    • “Roche’s Q1 sales beat estimates due to demand for drugs like Ocrevus and Hemlibra.
    • “Roche is boosting its U.S. manufacturing to avoid potential tariffs, investing $50 billion over five years.
    • “Roche maintains its full-year guidance, anticipating mid-single-digit sales growth.”
  • Healthcare Dive adds,
    • “Molina beat analyst expectations for earnings and revenue in the first quarter, with a topline of $11.1 billion, up 12% year over year, and net income of $298 million, down 1% year over year, according to results released Wednesday.
    • “The California-based insurer said its medical costs increased moderately in the quarter, mostly due to utilization of long-term supports and services, expensive drugs and behavioral health, along with more spending on seasonal illnesses like the flu. However, costs were generally in line with what Molina had predicted, a bright spot after UnitedHealth, the largest private insurer in the U.S., reported an unexpected spike in spending earlier this month.
    • “Molina’s results can be viewed as “good enough,” TD Cowen analyst Ryan Langston wrote in a note on the insurer’s first quarter performance.”
  • Per BioPharma Dive,
    • Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid looming threats of new tariffs from the Trump administration and regulatory uncertainty.
    • Sales climbed 9.7% to 9.9 billion euros, or $11.3 billion, in the period, beating the consensus analyst estimate of 9.6 billion euros. Earnings for the core business rose almost 16% to 1.79 euros a share, topping the consensus expectation of 1.70 euros a share.
    • The French drugmaker benefited from the launch of new drugs and the continuing growth of Dupixent, a blockbuster medicine used to treat conditions including asthma, eczema and chronic obstructive pulmonary disease. The drug’s sales jumped 20% to 3.5 billion euros in the quarter, Sanofi said Thursday.
  • Per MedTech Dive,
    • Medtronic is seeking Food and Drug Administration clearance for an interoperable version of its latest insulin pump, an important step in the manufacturer’s collaboration with diabetes technology rival Abbott. 
    • Medtronic said on Thursday that it made two 510(k) submissions to the FDA: one for its MiniMed 780G insulin pump as an alternate controller enabled device, and another for its SmartGuard insulin dosing algorithm as an interoperable automated glycemic controller.
    • The clearances would allow Medtronic’s technology to be part of an automated insulin delivery system, which can adjust insulin dosing to patients based on real-time readings from glucose monitors, using components made by other companies.
  • and
    • Edwards Lifesciences maintained full-year financial forecasts on Wednesday, projecting sales of its heart valves would offset hits from tariff and acquisition costs.
    • First-quarter sales of transcatheter aortic valve replacements, Edwards’ largest business, were better than the company expected, executives said on an earnings call.
    • Edwards’ TAVR sales were stifled last year by capacity constraints as heart teams performed more mitral and tricuspid valve procedures with the company’s newest devices. Hospitals are now addressing capacity issues by expanding capabilities for handling increased volumes, said Larry Wood, group president of TAVR and surgical structural heart. 
  • Modern Healthcare reports,
    • “Health systems have been shouldering the cost of mobile integrated healthcare programs for at-risk patients, but some insurers may be ready to start picking up the tab as providers prove they can save money.
    • “UMass Memorial Health, Geisinger, Prisma Health and others that operate these at-home care programs say the service saves millions of dollars by preventing emergency room visits and rehospitalizations of chronically ill patients. Government and private insurers have been covering little to none of the cost, but that could be changing as systems get information to prove the programs are effective.”
  • Mobihealth News informs us,
    • San Francisco-based Hinge Health, a digital musculoskeletal care platform, announced it is partnering with Cigna Healthcare to offer the health insurance company’s self-insured clients access to Hinge’s digital musculoskeletal (MSK) care platform. 
    • Hinge offers individuals with MSK conditions access to a multidisciplinary care team, including health coaches, orthopedic surgeons and physical therapists, as well as to digital tools like surgery decision support.
    • The company also provides a pelvic health program tailored for women and Enso, its FDA-cleared wearable that delivers electrical pulses to help alleviate everyday pain.
    • Cigna’s members who choose to enroll will have access to Hinge Health through Cigna’s condition-specific care program Pathwell Bone & Joint Solution.
    • Hinge touts that it is now an MSK provider for the five largest national health plans in the U.S. by self-insured lives. 
  • Per Fierce Healthcare,
    • “Health insurers can’t lose sight of improvements to the consumer experience as they find ways to reduce and manage rising costs, according to a new report from Forrester.
    • “The analysts offered one broad takeaway for payers: “Cut costs, not corners.” They noted that the industry is at a key crossroads where it’s critical to improve consumer experience and boost trust and consider those challenges as they build strategies around cost.
    • “Health insurers must improve CX, build consumer trust, and find innovative ways to create more sustainable cost structures and better economics for customers,” they wrote. “But the thirst for cost efficiency can’t cloud insurers’ strategic visions to create better health outcomes.”
  • Per Fierce Pharma,
    • “With the threat of Trump administration’s tariffs swirling and biopharma companies bracing for impact, many are announcing their intention to strengthen their presence in the U.S.
    • “The latest to hop on the invest-in-USA bandwagon is Thermo Fisher Scientific. The Massachusetts-based producer of medical instruments, diagnostics and pharmaceuticals will spend an additional $2 billion in the U.S. over the next four years “strengthening American innovation, manufacturing and economic competitiveness,” the company said in a release.
    • “Three-quarters of the pledge will bolster Thermo Fisher’s manufacturing operations, while the remaining $500 million will expand its R&D efforts.”

Midweek Report

David Ermer–CDC, COVID-19 vaccine, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, NIH, U.S. Healthcare–

From Washington, DC,

  • Federal News Network interviews Stephanie Kostro, executive vice president for policy at the Professional Services Council about the re-write of the Federal Acquisition Regulation that the President announced in an April 16, 2025, Executive Order.
  • Federal News Network adds,
    • “After laying off employees as part of its reduction in force (RIF), the Office of Personnel Management is now circulating a handful of job announcements to impacted employees that are nearly identical to their previous roles — only in a different OPM component.
    • “In an internal email obtained by Federal News Network, OPM notified the impacted staff members on Monday of five vacancies in OPM’s Human Resources Solutions (HRS) office, which manages the software for USA Jobs, USA Staffing and other federal HR products and services.”
  • Fierce Healthcare tells us,
    • “The National Institutes of Health (NIH) will begin work on a comprehensive federal database of patient records to study autism and chronic disease, Director Jay Bhattacharya, M.D., Ph.D., announced Monday. 
    • “The commitment gives legs to Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s calls to find the root cause of childhood autism, which he calls an epidemic. The NIH appears poised to put federal resources to work to create a central, shareable resource for the researchers that undertake RFK Jr.’s call to action.”

From the judicial front,

  • Healthcare Dive informs us,
    • “U.S. Bankruptcy Judge Stacey Jernigan approved Prospect Medical Holdings’ plan to begin winding down operations at Crozer Health on Tuesday, after lawyers for the health system said an 18 months-long effort to find new buyers for the facilities was unsuccessful.
    • “Emergency departments at Crozer-Chester Medical Center and Taylor Hospital, both in Delaware County, Pennsylvania, are set to stop receiving patients by ambulance this week. They’ll continue to accept walk-in patients for up to a week after, according to the hospitals’ closure plan, which attorneys characterized as evolving.
    • “The closure plan faced significant pushback from county officials, nurses and nonprofits who warn that closing the facilities will force residents to travel farther for care and could risk lives.”
  • STAT News reports,
    • “Amid ongoing battles over alternate supplies of blockbuster weight loss drugs, Eli Lilly filed new lawsuits against four telehealth firms and their affiliates but is using a new line of attack — the drugmaker accused two of the companies of engaging in the corporate practice of medicine.
    • “To date, Lilly and its rival, Novo Nordisk, have filed dozens of suits against numerous companies involved in compounding versions of semaglutide and tirzepatide, the obesity and diabetes drugs known as GLP-1s. For the past three years, telehealth firms, compounding pharmacies, and med spas have partnered to manufacture, prescribe and distribute copies of the drugs while shortages existed. Those lawsuits alleged trademark infringement, false claims and unfair competition, but have so far yielded varying outcomes.
    • “This time, Lilly has alleged two companies, Mochi Health and Fella Health, engaged in the corporate practice of medicine, which refers to controlling and influencing prescribing decisions of health care providers. They purportedly did so with the help of affiliated medical groups and compounding pharmacies, according to separate lawsuits filed on Wednesday in the U.S. District Court for the Northern District of California.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • “U.S. births grew 1% in 2024 to 3.6 million, according to preliminary data from the Centers for Disease Control and Prevention. The cesarean delivery rate slightly increased to 32.4% in 2024, from 32.3% in 2023. The 2024 preterm birth rate was 10.41%, unchanged from 2023.”
  • and
    • “There have been 8,064 reported cases of whooping cough in the U.S. so far this year, according to the latest data from the Centers for Disease Control and Prevention. There were 3,835 cases at the same time in 2024.”
  • Per today’s American Medical Association’s Morning Rounds,
    • “The New York Times (4/22, Gross) reports that “neuroscientists have learned that estrogen is vital to healthy brain development but that it also contributes to conditions including multiple sclerosis and Alzheimer’s. Changes in estrogen levels – either from the menstrual cycle or external sources – can exacerbate migraines, seizures and other common neurological symptoms.” In the brain, “estrogen can bind directly to receptors within neurons and other cells, setting off a cascade of actions. It can also be broken down into metabolites, called neurosteroids, which exert their own far-reaching effects.” Researchers also know that estrogen “can modulate neuron firing, reduce inflammation, increase neuroplasticity, help turn glucose into energy, prevent plaque from building up and improve blood flow in the brain.” A recent review published in Brain Medicine suggests there are a “huge number of neurological diseases that can be affected by sex hormone fluctuations.”
  • The Wall Street Journal reports,
    • “Mounting evidence suggests that vaccination against the varicella zoster virus—which causes chickenpox in children and triggers shingles in adults—also protects the brain.  
    • “Several recent studies suggest that the vaccines reduce the risk of dementia in older adults, but key questions remain, including How the vaccines might work to stop or delay the condition, and whether the benefit is limited to people of a certain age. 
    • “The vaccines studied, Zostavax and Shingrix, both appeared to offer protection. 
    • “The latest study found that among 70- and 80-year-olds in Australia, people who were eligible to get the Zostavax shot were 1.8 percentage points less likely to get a dementia diagnosis in the next 7.4 years than those who were ineligible. The study was published in the journal JAMA Wednesday.”
  • Per a National Cancer Institute (NCI) news release,
    • “New immune-based treatments for kidney and pancreatic cancer have shown promising results in two small clinical trials. In both trials, the treatments appeared to prevent cancer from returning in patients who had successful surgery to remove their tumors.
    • “The treatments are called therapeutic cancer vaccines because they help the immune system eliminate an existing cancer. 
    • “In both trials, the treatments were made specifically for each patient based on intensive genetic analyses of their tumor samples collected during surgery. The analyses allowed the research teams to identify mutated proteins, known as neoantigens, on each patient’s cancer cells. These rogue proteins can act like an activated security alarm to the immune system, alerting it that the cancer cells are threats that should be killed. 
    • “For different reasons, however, this alarm system fails. The neoantigen-based treatments are designed to step into this breach, reinforcing to the immune system that any cells displaying these mutated proteins must be eliminated.
    • “In both studies, patients received multiple doses of their personalized treatments in the months following surgery. Giving the therapy after surgery is intended to kill any remaining cancer cells elsewhere in the body and potentially establish a small band of immune cells that can recognize and kill any cancer cells that pop up in the future.”
  • The NCI’s Cancer Information Highlights consider “Physical Activity | Dormant Cancer Cells | Young People with Advanced Cancer.”
  • Per STAT News,
    • “The young people who wanted to quit e-cigarettes didn’t necessarily think they were addicted. But they did think nicotine cravings were a problem. When they enrolled in a Massachusetts General Hospital trial, they told researchers they couldn’t study in the library or work at their desks for long before getting the urge to vape. “They really didn’t like that loss of control,” said Eden Evins, director of the Center for Addiction Medicine at Mass General.
    • “Using the oral pill varenicline in combination with behavioral counseling is the most effective way for young people to get that control back, according to the results of the study co-authored by Evins, published Wednesday in the Journal of the American Medical Association. Of participants ages 16 to 25, half of those who took varenicline for 12 weeks were able to abstain from e-cigarettes for the last month of that period, compared to 14% of the placebo group. After a total of six months, 28% of people in the varenicline group were still vape-free, compared to 7% of the placebo group.” 
  • Per Fierce Pharma,
    • “Akeso and Summit Therapeutics’ giant-killing, PD-1xVEGF bispecific antibody ivonescimab has posted another phase 3 trial win in lung cancer, this time as part of a chemotherapy combination. 
    • “An independent data monitoring committee has determined that the HARMONi-6 trial for the first-line treatment of advanced squamous non-small cell lung cancer (NSCLC) has met its primary endpoint of progression-free survival (PFS), Akeso said Tuesday.
    • “At the first pre-specified interim analysis of the 532-patient Chinese study, ivonescimab plus chemotherapy “decisively beat” BeiGene’s PD-1 inhibitor Tevimbra plus chemotherapy, Akeso said. The results—which will be presented at a medical conference later this year—were “statistically significant and clinically meaningful,” the Chinese company added.”
  • and
    • “Schizophrenia drug Cobenfy, a key component in Bristol Myers Squibb’s plan to navigate a transition period of major loss of exclusivity, has hit a phase 3 setback.
    • “Cobenfy as an adjunctive treatment to atypical antipsychotics failed to show superior efficacy versus placebo with atypicals when used in patients with inadequately controlled schizophrenia, according to results from the phase 3 Arise trial, Bristol Myers said Tuesday.
    • “The trial logged a numerical improvement, with adjunctive Cobenfy showing a 2-point reduction compared with placebo on the primary endpoint of reduction in the Positive and Negative Syndrome Scale (PANSS) total score at week 6. However, the number didn’t reach statistical significance. PANSS is a clinician-administered tool used to assess schizophrenia symptoms.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Healthcare spending continues to plague employers — but most aren’t yet taking sizable steps to curb costs.
    • “Nearly 85% of employers say surging healthcare prices are their biggest benefits challenge, according to a survey of about 1,800 plan sponsors nationwide published Wednesday from insurance brokerage and consulting company Lockton.
    • “Employers are bracing for healthcare costs to balloon 6%-8% this year, especially as workers seek more expensive specialty care.”
  • Becker Payer Issues adds,
    • “There may be a link between rising insurance premiums and increased utilization of services, particularly across the Medicare Advantage space.
    • “In its first quarter earnings report, UnitedHealth Group reduced its year-end earnings outlook amid rising use of physician and outpatient services among its Medicare Advantage membership and “unanticipated changes in the profile of Optum Health members.”
    • “One key insight that emerged from the company was a major rise in elective care activity, which was linked directly to the higher premiums faced by some of UnitedHealth’s group MA members. The company reported that among some public sector retiree groups, premiums had increased dramatically (in some cases by as much as $150 a month) from $50 to $200. Instead of disengaging from using their benefits, these members appear to have engaged more than usual.
    • “We’re seeing a significant and disproportionate increase in utilization largely within our public sector group retiree business. This population experienced the greatest year-over-year premium increases,” UnitedHealthcare CEO Tim Noel told investors. “We did assume that we would see some care activity level increases in this population, but we’re seeing far surpasses what we would have recently anticipated. And in that population as well, we are seeing more preventative care, more annual wellness visits, more in-home clinical assessments. The driver there is also really the follow-on care that results from that.”
  • Fierce Healthcare relates,
    • “Community Health Systems’ narrow first-quarter net loss landed right in line with Wall Street’s expectations, though the public for-profit hospital operator increased its net operating revenue on solid demand, according to financial results released Wednesday after market close.
    • “Even though healthcare providers are navigating significant change as our operating environment continues to evolve, we remain confident that our strategies are strengthening our operations and positioning the company for long-term success,” CEO Tim Hingtgen said in the results announcement.
    • “Net loss attributable to the company was $13 million (-$.10 per diluted share), an improvement over the $41 million loss (-$0.32) of the prior year’s first quarter—though the losses were narrower for both periods after adjustments (for impairment and loss on sale of business and related costs).
    • “Net operating revenues landed at $3.16 billion, just above expectations and a 0.6% year-over-year increase. On a same-store basis taking CHS’ recent divestitures into account, net operating revenues rose by 3.1%. Both of those came alongside a 1% decrease in total admissions and a 2.3% dip in adjusted admissions, but respective same store increases of 4% and 2.6%.”
  • MedTech Dive notes,
    • “Boston Scientific CEO Mike Mahoney told investors Wednesday the company expects an impact of about $200 million this year due to the Trump administration’s tariff policies, becoming the latest medtech company to forecast an impact of hundreds of millions of dollars.
    • “However, Boston Scientific, like others that have reported, still expects to perform well in 2025. Mahoney said Boston Scientific is “very bullish” on the year, and the firm raised its 2025 guidance from a growth range of 12.5%-14.5% on a reported basis to 15%-17%, even with the $200 million charge.”
  • Per KFF,
    • “The growing role of Medicare Advantage has been a defining feature of Medicare in recent years, with Medicare Advantage plans now covering more than half of all eligible Medicare beneficiaries. While most Medicare Advantage enrollees (and most people with Medicare overall) live in urban areas, as of 2024, most Medicare beneficiaries who live in the nation’s most rural counties are enrolled in traditional Medicare, not Medicare Advantage. This means that reliance on Medicare’s stand-alone prescription drug plans (PDPs) for coverage of the Medicare Part D prescription drug benefit is likely to be greater among Medicare beneficiaries living in the most rural parts of the country.”
  • MedPage Today lets us know,
    • “Novavax’s closely watched COVID-19 vaccine is on track for full approval after additional discussions with the FDA, the company said Wednesday.
    • “The news sent company shares soaring more than 21% in morning trading and appeared to resolve concerns that Trump administration officials might be holding up a decision on the shot.
    • “Novavax makes the nation’s only traditional protein-based COVID-19 vaccine. It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups.”

Tuesday Report

David Ermer–AHRQ, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, U.S. Healthcare–

From Washington, DC,

  • STAT News reports,
    • “National Institutes of Health director Jay Bhattacharya on Monday asserted that the agency remains committed to research that advances the health of minorities — despite the Trump administration’s sharp focus on rolling back programs dealing with diversity, equity, and inclusion.
    • “Bhattacharya said that President Trump’s executive orders, which state that DEI programs are illegal and discriminatory and direct federal agencies to terminate any of their own such programs, are “misunderstood.”
    • “I don’t think that [the orders are] aimed at stopping fundamental research that advances the health and wellbeing of minority populations. I wouldn’t have accepted this job if that was the case,” he said. “I think that the health and wellbeing of minority populations, as well as every American, are a central focus of the NIH and will continue to be under my watch.”
  • The NIH’s understanding matches the FEHBlog’s reading of those DEI program executive orders, which are directed at workforces, not healthcare.
  • The Wall Street Journal adds,
    • “For months, investors have feared that Health and Human Services Secretary Robert F. Kennedy Jr. and his Make America Healthy Again movement would derail biomedical innovation. His ousting of Peter Marks—a senior official at the Food and Drug Administration and key proponent of faster drug approvals—sent biotech stocks tumbling last month and stoked concerns that the agency was being politicized and turned against science.
    • “A more nuanced narrative is now taking shape. 
    • “While heightened vaccine scrutiny and sweeping FDA staff cuts remain serious threats, recent signals have been more upbeat. In an interview late last week, newly appointed FDA Commissioner Marty Makary—a former Johns Hopkins surgeon—delivered a relatively bullish message for the biotech sector. Speaking with Megyn Kelly, Makary said he would speed up approvals for rare-disease treatments, cut reliance on animal testing by incorporating computational models and shorten the industry’s typical 10-year drug- development timeline.
    • “He also vowed to reduce pharmaceutical companies’ influence over the FDA approval process and end what he called the agency’s “cozy” relationship with the industry. Importantly, he emphasized a commitment to protecting innovation and maintaining a science-based approach to regulation.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s broader initiative to Make America Healthy Again.
    • “The FDA is taking the following actions:
      • “Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
      • “Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
      • “Working with industry to eliminate six remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
      • “Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others.
      • “Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
      • “Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.”
  • The U.S. Public Health Service Task Force posted the following draft grade B recommendation that applies to “Pregnant and postpartum women who are at increased risk of perinatal depression.”
    • “The USPSTF recommends that clinicians provide or refer those at increased risk of perinatal depression to counseling interventions during pregnancy and the postpartum period.”
    • The recommendation notes “When final, this recommendation will update the 2019 recommendation statement on interventions to prevent perinatal depression. The current draft recommendation is consistent with the 2019 recommendation; both are B recommendations”
    • The public comment period ends on May 19, 2025.

From the public health and medical research front,

  • The New York Times reports,
    • “The spread of measles in the Southwest now constitutes the largest single outbreak since the United States declared the disease eliminated in 2000, federal scientists told state officials in a meeting on Monday.
    • “The New York Times obtained a recording of the meeting. Until now, the Centers for Disease Control and Prevention had not publicly described the outbreak in such stark terms.
    • “More measles cases were reported mostly in Orthodox Jewish communities in New York City and New York State in 2019. But health officials regard those as separate outbreaks, because they were fueled by multiple introductions of the virus by international travelers.
    • “C.D.C. officials now view the spread of measles in Texas, Oklahoma and New Mexico as a single outbreak, Dr. Dan Filardo, who leads the agency’s task force for the measles response, told state health officials at the meeting.”
  • Medscape makes five long COVID predictions for 2025 and beyond.
  • The American Hospital Association News tells us,
    • “A study published April 17 by BMC Infectious Diseases found increased incidents of Acinetobacter baumanniiand carbapenem-resistant A. baumannii infections between 2018 to 2022. A. baumannii is a pathogen considered to be a major cause of health care-associated infections. The study found that A. baumannii cases per 100 hospitalization encounters grew from 1.15 in 2018 to 1.25 in 2021, before dropping to 1.11 in 2022. The CRAB incidence rate grew from 0.39 cases per 100 hospitalization encounters in 2018 to 0.53 cases in 2022. 
    • “Researchers said the pathogen’s ability to survive in hospitals and in patients not showing any symptoms for extended periods of time contributed to increased outbreaks.” 
  • MedPage Today points out,
    • “Cytisinicline increased biochemically confirmed abstinence [from smoking tobacco] nearly threefold versus placebo when taken for 6 weeks and more than fourfold when taken for 12 weeks.
    • “The drug was well tolerated with no treatment-related serious adverse events.
    • “The trial is expected to support filing with the FDA for a new drug indication as a tobacco-product cessation aid.”
  • Beckers Hospital Review notes,
    • “A recent study found that changing the default prescription length for statins to 90 days significantly increased the number of long-term prescriptions written, potentially improving patient adherence. 
    • “The intervention, which was implemented at the University of Pennsylvania’s health system in Philadelphia, set 90-day prescriptions as the default option in the electronic health record for statins. By the end of the study, the health system saw the proportion of 90-day prescriptions rise from 71% to 91%, according to an April 22 news release from Penn Medicine. 
    • “The study, published in JAMA Internal Medicine on April 7, found that the change designed as a “nudge” to guide doctors toward better prescribing behavior had helped to reduce the need for patients to visit the pharmacy multiple times a year. 
    • “The findings suggest that default settings in EHRs can be a tool in increasing medication adherence without additional effort from clinicians, the release said.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance posted mixed results for the first quarter but reaffirmed its 2025 earnings outlook, solidifying guidance it published early to pacify investors after UnitedHealth posted dismal results last week, leading to a selloff of health insurer stocks.
    • “UnitedHealth’s results were driven by unexpectedly high medical spending on Medicare Advantage members, a trend that Elevance on Tuesday said it had observed but wasn’t any more drastic than expected.
    • “Overall, Elevance beat Wall Street expectations in the quarter with revenue of $48.9 billion, up almost 15% year over year, in part due to the higher premiums it’s charging customers this year in a bid to resuscitate insurance margins. The insurer posted profit of $2.2 billion, down 3% year over year. Elevance’s stock was up slightly in morning trading following the results.”
  • Per MedCity News,
    • “With rising operational costs, major shifts in Medicaid, and other financial pressures bearing down on the healthcare system, forecasting revenue and allocating resources effectively has never been as important for health plans as it is today. And anticipating the future has probably never been so challenging.
    • “Health plans have been gradually deploying artificial intelligence programs and sophisticated analytics for years to make programs more effective while reducing costs and mitigating financial risk.
    • “But with today’s challenges, the gradual approach has become a luxury. According to McKinsey, health plans should pick up the pace.”
  • Modern Healthcare adds,
    • “Payers, providers and health technology companies may soon be asking accrediting organizations to sign off on their use of artificial intelligence.
    • “AI is being used across the industry but a lack of regulation at the state and federal levels is prompting industry stakeholders to create their own guidelines for safe and effective AI use. The next step might well see the issue addressed in accreditation programs.
    • “While the AI accreditation process could take years to develop, there is confidence that it will become commonplace. On top of the potential impact of AI on patient outcomes, there is a cost to develop and adopt products. This cost factor is driving the need for more transparency on model efficacy, said Dr. Lee Schwamm, chief digital health officer at New Haven, Connecticut-based Yale New Haven.”
  • The Wall Street Journal reports,
    • “Swiss pharmaceutical giant Roche ROG -0.31%decrease; red down pointing triangle
      plans to invest $50 billion in the U.S. over the next five years, the latest major spending commitment by a big drugmaker as the industry faces President Trump’s tariff threats.” * * *
    • “The investment by Roche will fund new research hubs and new and expanded manufacturing facilities in Indiana, Pennsylvania, Massachusetts and California, the company said Tuesday. The company said that investment would create 1,000 jobs at Roche and more than 11,000 elsewhere including nearly 6,500 construction jobs.
    • “The company currently has 15 R&D centers and 13 manufacturing sites in the U.S., employing more than 25,000 people.
    • “Roche said it would export more medicines from the U.S. than it imports once its new and expanded manufacturing site are in operation. The group’s diagnostics division currently already holds a surplus from the U.S., it said.”
  • MedCity News relates,
    • “Aeroflow Health, a health tech company, last week announced a new diabetes management program, which aims to improve adherence, outcomes and care coordination for health plan members.
    • “Asheville, North Carolina-based Aeroflow Health was founded in 2001 and offers an array of medical devices covered by insurance. The company has four lines: Aeroflow Breastpumps, Aeroflow Diabetes, Aeroflow Sleep and Aeroflow Urology. In addition to medical devices, it provides education and consultations. The company has partnerships with more than 1,000 insurance plans and serves more than 1.4 million patients annually.
    • “Through the new diabetes program, patients gain access to educational content on how to manage their condition, including medication adherence, lifestyle modifications and glucose monitoring strategies. They can also use a new AI-powered digital health tool that syncs with continuous glucose monitoring data. This allows patients to receive personalized insights on their health, AI-driven coaching and communication with their provider.”

Tuesday Report

David Ermer–AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Bloomberg Law reports,
    • “President Donald Trump wants Congress to change a policy that gives certain drugs longer protection from drug price negotiations in Medicare, a fix that could address one of the drug industry’s top complaints with the Biden-era law.
    • “Trump directed his health secretary to work with lawmakers to end the differential treatment for small molecule drugs, typically pills, that face Medicare price negotiations sooner that more complex biologic medications.
    • “The directive came in an executive order Trump signed at the White House Tuesday. The order was light on specifics and included a grab-bag of other health policy goals.”
  • Modern Healthcare adds
    • “A bipartisan group of state attorneys general wants Congress to pass legislation that would break up healthcare conglomerates such as UnitedHealth Group, CVS Health and Cigna.
    • “Under the auspices of the National Association of Attorneys General, more than three dozen officials wrote congressional leaders on Monday asking them to ban companies from owning both pharmacy benefit managers and pharmacies, citing anticompetitive effects of consolidation in the healthcare system.”
    • Here is a link to that letter.
  • Fierce Pharma tells us,
    • “A two-day meeting of the Advisory Committee on Immunization Practices (ACIP), which was originally scheduled for February but was postponed by new HHS Secretary Robert F. Kennedy Jr., is underway today [April 15] in Atlanta and will conclude with panel votes on several vaccines on Wednesday afternoon.
    • “The independent advisers, who meet three times a year to inform vaccine policies in the U.S., today will discuss (PDF) the effectiveness of vaccines that defend against COVID-19, Mpox, chikungunya, HPV, cytomegalovirus (CMV) and the flu.
    • “The last item on Tuesday’s agenda will be an update on the U.S. measles outbreak. On Friday, the Centers for Disease Control and Prevention (CDC) reported 712 cases in more than 20 states, with the most concentrated spread underway in West Texas.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), a member of the Senate Agriculture Committee and a lifelong family farmer, joined Sens. Pete Ricketts (R-Neb.) and Deb Fischer (R-Neb.), along with Reps. Randy Feenstra (R-Iowa) and Mark Alford (R-Mo.), in a letter urging the Make America Healthy Again (MAHA) Commission to use sound science and risk-based analysis in its policy decisions, particularly on crop protection tools and food-grade ingredients.
    • The letter was sent to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, Department of Agriculture (USDA) Secretary Brooke Rollins and Environmental Protection Agency (EPA) Administrator Lee Zeldin.
      • “We write to express our strong appreciation for your leadership and interest in working with each of you to ensure America has the healthiest people in the world. In recent decades, chronic illness rates have risen. This warrants our careful scrutiny to support better health outcomes. It is essential that policies supported by sound science and risk-based analyses are used to accomplish this goal,” the lawmakers wrote.
      • “We have concerns that environmentalists are advancing harmful health, economic, or food security policies under the guise of human health. Despite insinuations to the contrary, regular testing by FDA and USDA finds that more than 99% of all pesticide residues meet extremely conservative limits established by EPA according to the best available science,” they continued.”
    • Here’s a link to the letter.

From the judicial front,

  • Bloomberg Law tells us,
    • “The Central States, Southeast and Southwest Areas Health and Welfare Fund and participant Charles A. Whobrey sued Arkansas Insurance Commissioner Alan McClain April 11, arguing a law requiring health plans to report pharmacy cost data and pay pharmacies a minimum amount violates the Employee Retirement Income Security Act. 
    • “The multiemployer benefit plan serves 500,000 people via local chapters of the International Brotherhood of Teamsters.
    • “It’s the latest in a broader legal fight over states’ attempts to regulate pharmacy benefit managers, which oversee the prescription drug benefit for health plans. The US Supreme Court is weighing whether to accept a case challenging an Oklahoma law regulating pharmacy benefit managers after determining that ERISA did not preempt a separate Arkansas PBM law in 2020.” * * *
    • “The case is Central States, Southeast and Southwest Areas Health and Welfare Fund et al v. McClain, in his official capacity as Insurance Commissioner of Arkansas et al., N.D. Ill., No. 1:25-cv-03938, complaint filed 4/11/25.”

From the public health and medical research front,

  • The National Academy of Sciences announced,
    • “Bird flu has infected livestock, wildlife, pets, and humans. Most people have general questions about the looming threat of this highly pathogenic virus, and we have answers. Join @NASEM Health and Medicine Division and @NASEM Earth & Life Sciences on April 29, 2025, for the first public webinar of a special series addressing H5N1 avian influenza. Learn how we got here, who’s at risk, and what’s at stake. Can’t make the date/time? All registrants will receive a link to the recording. Register here: https://tinyurl.com/bdhrywv2
  • The New York Times reports,
    • “The number of children living with autism in the U.S. is growing.
    • “About 1 in 31 children aged eight years old in 2022 had autism—an increase from previous years, according to a report from the Centers for Disease Control and Prevention published Tuesday. 
    • “Increased awareness and screening of the disorder partly explains its rise over time. Health and Human Services Secretary Robert F. Kennedy Jr. has said he is assembling a team of researchers to focus on the root causes of the increase and expects to begin to have answers by September. 
    • “The autism epidemic has now reached a scale unprecedented in human history because it affects the young,” he said Tuesday. “Autism is preventable and it is unforgivable that we have not yet identified the underlying causes. We should have had these answers 20 years ago.”
    • “The idea that vaccines cause autism, which Kennedy has pushed, has long been debunked by scientists, after multiple studies have failed to find a link.”
  • The Rand Organization informs us,
    • “Specialized hospital services that aid people with opioid use disorder regardless of why they are admitted can boost the number of patients who begin treatment with FDA-approved medication for opioid use disorder and increase the likelihood they remain engaged in that care once discharged, according to a new study.
    • “Reporting results from the first parallel assignment randomized clinical trial of a hospital-based addiction consultation service for people with opioid use disorder, researchers found that people who received treatment from a specialized addiction consultation service were about twice as likely to begin medication treatment for opioid use disorder as patients who received the normal course of care.
    • “In addition, those who received care from the special program were significantly more likely to link to care for opioid use disorder once they were discharged.
    • “Researchers say the study contributes to growing evidence that an inpatient addiction consultation service can have a positive effect on treatment initiation and linkage to post-discharge care. The findings are published in the journal JAMA Internal Medicine.”
  • AHRQ offers advice on “Implementing [US Preventive Services Task Force] Recommended Mental Health and Substance Use Screening and Counseling Interventions in Primary Care Settings for Children and Adolescents.”
  • Per Medscape,
    • “New data confirmed the safety and efficacy of AXS-05, a combination of dextromethorphan and bupropion, for the treatment of agitation associated with Alzheimer’s disease (AD).
    • “In the phase 3 ACCORD-2 study, AXS-05 (Axsome Therapeutics) met the primary and key secondary endpoints by statistically significantly delaying and preventing AD agitation relapse compared with placebo and was generally well tolerated.
    • “Overall, the data “build on the previous positive phase 2/3 studies and support the use of AXS-05 as a safe and effective treatment for Alzheimer’s disease agitation,” George Grossberg, MD, Saint Louis University School of Medicine, St. Louis, said at a press briefing announcing the results.
    • “Grossberg presented the late-breaking findings from ACCORD-2 on April 7 at the American Academy of Neurology (AAN) 2025 Annual Meeting.”
  • Per a National Cancer Institute news release,
    • “Many adolescents and young adults (AYAs) with advanced cancer don’t have discussions with their clinicians about how they want to approach palliative care until the final weeks of life, a study of medical records of nearly 2,000 young patients showed.
    • “The researchers also found that, as of more than 2 months before their deaths, few AYAs in the study had documented goals for care of any kind in their medical records, including things such as how aggressive they would like to be with their cancer treatments.
    • “The findings come from an NCI-funded study that analyzed how documented discussions between AYA patients with advanced cancer and their providers about the goals of care change over the patients’ last few months of life.  The study results were published December 19 in JAMA Network Open.”
  • Per an NIH news release,
    • “New studies in rats suggest the drug reserpine, approved in 1955 for high blood pressure, might treat the blinding disease retinitis pigmentosa. No therapy exists for this rare inherited disease, which starts affecting vision from childhood. A report on the studies, conducted at the National Institutes of Health (NIH), published today in eLife.
    • “The discovery of reserpine’s effectiveness may greatly speed therapeutics for retinitis pigmentosa and many other inherited retinal dystrophies, which can be caused by one of more than a thousand possible mutations affecting more than 100 genes. Reserpine’s neuroprotective effect is independent of any specific underlying gene mutation,” said the study’s lead investigator, Anand Swaroop, Ph.D., senior investigator at NIH’s National Eye Institute.”
  • STAT News reports,
    • “U.S. researchers will soon test whether livers from a gene-edited pig could treat people with sudden liver failure — by temporarily filtering their blood so their own organ can rest and maybe heal.
    • “The first-of-its-kind clinical trial has been cleared by the Food and Drug Administration, according to pig producer eGenesis, which announced the step Tuesday with its partner OrganOx.” * * *
    • “The new study, which is expected to get underway later this spring, is a twist on the quest for animal-to-human organ transplants. Researchers won’t transplant the pig liver but instead will attach it externally to study participants.
    • “The liver is the only organ that can regenerate, but the question is whether having the pig’s liver filter the patient’s blood for several days could give it that chance.”

From the U.S. healthcare business front,

  • Beckers Payer Issues notes,
    • “CMS’ payment increase of 5.03% in 2026 “will likely significantly support the recovery” of Medicare Advantage plans as they continue to face rising medical costs, according to Fitch Ratings.
    • “Increased government scrutiny, reduced base payments and rising utilization in the last couple of years has put pressure on the program, leading plans to reduce benefits or pull back from unprofitable markets. CMS’ rate hike will increase payments to MA plans by more than $25 billion in 2026.
    • “While the higher 2026 payment rates do not resolve all the challenges facing MA insurers, they help relieve some pressures from increased healthcare utilization in the program,” Fitch analysts wrote April 14. “Depending on the insurer, the higher rates could enable a mix of enhancement of benefits in certain geographies, mitigation of Star Ratings pressure, or partial margin recovery.”
    • “Fitch expects MA to remain a key focus for insurers, and a clearer picture on the success of course correction measures will become available in the next few weeks as Q1 earnings reports are released.”
  • Per Fierce Pharma,
    • “Even as tariffs start to take a toll on Johnson & Johnson’s medtech business—with the threat of pharmaceutical duties not far behind—the New Jersey drug giant is confident it can weather any upcoming trade war turbulence. In fact, the company is boosting its sales guidance for the year following the close of a new neuroscience acquisition.
    • “J&J now expects to generate total operational sales of $91.6 billion to $92.4 billion in 2025, representing a $700 million increase over the forecast it initially unveiled in January, the company said in a Tuesday earnings release (PDF).
    • “J&J’s finance chief, Joseph Wolk, attributed the bump to J&J’s recent acquisition of neuroscience player Intra-Cellular Therapies for $14.6 billion. The deal, which closed earlier this month, allowed J&J to get its hands on the approved schizophrenia and bipolar disorder med Caplyta.”
  • Per Beckers Hospital Review,
    • “At the end of 2023, more than one-third of new prescriptions to treat Type 2 diabetes were GLP-1s, such as Mounjaro and Ozempic, among others, according to a study published April 15 in Annals of Internal Medicine. 
    • “Researchers at Mass General Brigham, based in Somerville, Mass., reviewed claims data from January 2021 to December 2023 to evaluate utilization trends among diabetes medications. 
    • “The drugs included glucagon-like peptide-1 receptor agonists (Ozempic), glucose-dependent insulinotropic polypeptide receptors (Mounjaro), glucose-lowering medications (metformin and insulin) and weight-lowering medications (phentermine). 
    • “Over those three years, use of Mounjaro, Ozempic and sodium-glucose cotransporter-2 inhibitors increased among adults with Type 2 diabetes. Use of other glucose-lowering drugs, including metformin, rapidly declined.
  • and
    • “Houston-based Texas Children’s has experienced “astounding” results from AI projects in recent months, its IT leader told Becker’s.
    • “Myra Davis, executive vice president and chief information and innovation officer of Texas Children’s, was recently recognized for her work when she was nominated for an ORBIE award for the nation’s top healthcare CIO.
    • “Becker’s caught up with Ms. Davis to discuss her most innovative IT projects — and what comes next.”
  • The New York Times reports,
    • “The quest to create an A.I. therapist has not been without setbacks or, as researchers at Dartmouth thoughtfully describe them, “dramatic failures.”
    • “Their first chatbot therapist wallowed in despair and expressed its own suicidal thoughts. A second model seemed to amplify all the worst tropes of psychotherapy, invariably blaming the user’s problems on her parents.
    • “Finally, the researchers came up with Therabot, an A.I. chatbot they believe could help address an intractable problem: There are too many people who need therapy for anxiety, depression and other mental health problems, and not nearly enough providers.
    • “Fewer than a third of Americans live in communities where there are enough mental health providers to meet the local demand. According to one study, most people with mental health disorders go untreated or receive inadequate treatment.
    • “So the team at Dartmouth College embarked on the first clinical trial of a generative A.I. therapist. The results, published in the New England Journal of Medicine-AI, were encouraging.
    • “Chatting with Therabot, the team’s A.I. therapist, for eight weeks meaningfully reduced psychological symptoms among users with depression, anxiety or an eating disorder.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Monday said its drug Camzyos failed a Phase 3 trial in people with a progressive heart condition, closing off an opportunity to expand use of a medicine it sees as a future blockbuster.
    • “According to Bristol Myers, Camzyos missed the dual main goals of a study focused on the non-obstructive form of “HCM,” or hypertrophic cardiomyopathy. It failed to meaningfully improve peak oxygen consumption as well as scores on an assessment of heart health. The company didn’t provide study details, but said more information will be shared “with the scientific community in the future.”
    • “Camzyos was acquired through the $13 billion buyout of MyoKardia in 2020 and two years later became the first drug cleared for use in the “obstructive” and more common form of the disease. Biotechnology companies Cytokinetics and Edgewise Therapeutics are developing similar medicines that are both in the advanced stages of clinical testing. Cytokinetics’ drug, aficamten, could be approved in the U.S. later this year.”

Friday Report

David Ermer–AHRQ, CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC.

  • Medical Economics reports,
    • Health care is in crisis, but tying physician reimbursement to inflation is one way to stabilize the American health care system, according to the American Medical Association (AMA).
    • On April 10, the Medicare Payment Advisory Commission voted unanimously to recommend Congress replace current law updates to the physician fee schedule with an annual change based on the Medicare Economic Index, such as MEI minus 1%.
    • That is “a timely recommendation as lawmakers wrestle with how to handle yet another cut in physician pay,” according to AMA. Association President Bruce A. Scott, MD, issued a statement of support similar to previous ones because the issue has been under discussion for months. In fact, Scott noted MedPAC has suggested the same to Congress at least three consecutive years.
      The current baseline increase to physician reimbursement is 0.25%, or 0.75% for doctors participating in an alternative payment model. MedPAC said Congress should consider setting reimbursement at the rate of the Medicare Economic Index minus 1%, every year for the foreseeable future.
  • Fierce Healthcare lets us know,
    • “A new assessment of 18 Center for Medicare and Medicaid Innovation models reaffirms recent criticism of the agency’s aggregate cost savings—or more accurately, losses—while highlighting several individual payment models that appear effective in cutting down federal spending and improving care quality.
    • “The white paper published Wednesday by healthcare consulting and advisory firm Avalere Health looked at newer quality metrics for outcomes than prior CMMI model analyses and also dug into whether the agency had been transparent and provided opportunities for feedback when designing the models.
    • “The findings come in the wake of a damning late 2023 Congressional Budget Office assessment of the agency’s work, which found CMMI increased indirect spending by $5.4 billion between 2011 and 2020 (0.1% of net Medicare spending during that time) and spurred sharp scrutiny from cost-conscious lawmakers.”
  • and
    • “Disability protections against gender dysphoria implemented via rulemaking during the Biden administration will not be supported going forward, the Department of Health and Human Services (HHS) announced April 10.
    • “In a two-page clarification, HHS Secretary Robert F. Kennedy Jr. signed off on a rule update that declares language characterizing gender dysphoria as a disability to not be enforceable because its inclusion was in the preamble—not the regulatory text—to a final rule from May 2024.
    • “The Department is nonetheless concerned there has been significant confusion about the preamble language referencing gender dysphoria in the [final rule],” the update (PDF) in the Federal Register reads. “It is well-established that where, as here, the language included in the regulatory text itself is clear, statements made in the preamble to a final rule published in the Federal Register, lack the force and effect of law and are not enforceable.”
  • Federal News Network tells us, “OPM lacks funds to relocate ‘significant’ number of remote employees in return-to-office plans. OPM is joining many agencies in giving employees another chance to take a “deferred resignation” offer before it proceeds with nonvoluntary layoffs.”
  • Tammy Flanagan, writing in Govexec, informs us about “What to know about early retirement offers to federal employees.

From the Food and Drug Administration front,

  • Fierce Pharma relates
    • “Bristol Myers Squibb has received the FDA’s green light to introduce another immunotherapy-based treatment in first-line liver cancer.
    • “The company’s combination of Opdivo and Yervoy is now approved for patients with newly diagnosed unresectable or metastatic hepatocellular carcinoma, the FDA said Friday.
    • “The immunotherapy regimen combines two well-established agents and may offer the potential for a longer life compared with traditional targeted therapy, Wendy Short Bartie, Bristol Myers’ senior VP of U.S. oncology commercialization, said in an interview with Fierce Pharma.
    • “The first-line approval also converted a previous accelerated approval for Opdivo-Yervoy as a second-line liver cancer treatment. Further, it puts BMS toe to toe with two other immuno-oncology regimens—Roche’s Tecentriq and Avastin, and AstraZeneca’s Imfinzi and Imjudo.”
  • Per MedTech Dive,
    • “Intuitive said Thursday the Food and Drug Administration has cleared a stapler for use with its single-port robotic surgery system.
    • “The device, which Intuitive said is the first stapler designed for single-port robotic surgery, shares features found in the company’s multi-port products to reduce the risk of tissue damage.
    • “CFO Jamie Samath said in January that the stapler nod would trigger the start of “broad commercial efforts” for the single-port system in two indications recently authorized by the FDA.”
  • and
    • “Dexcom received Food and Drug Administration clearance for a 15-day version of its G7 glucose sensor, the company announced Thursday.
    • “Dexcom claims its continuous glucose monitor is the most accurate and has the longest wear time. The company also expects the shift from a 10-day to a 15-day sensor to improve its margins, executives said in a February earnings call.
    • “The announcement alleviated investor concerns that a recent FDA warning letter might delay the decision. Dexcom expects a full launch in the second half of 2025, giving the company time to integrate the updated device with insulin pumps.”

From the judicial front,

  • The Congressional Research Service offers a legal sidebar about the impending April 21 oral argument in the Kennedy v Braidwood Management case which concerns the Affordable Care Act’s preventive care services coverage mandate.
  • Bloomberg Law reports,
    • “A Maine woman can’t proceed with a suit claiming that her health insurance plan’s coverage exclusion for weight loss drugs unlawfully discriminates against obese people, a federal court said.
    • “Rebecca Holland didn’t allege any facts showing that Elevance Health Inc. ever regarded her or other obese plan members as disabled, the US District Court for the District of Maine said Wednesday. Her “bare conclusory allegations to the contrary” didn’t support a ruling that the exclusion was discriminatory, Chief Judge Lance E. Walker said.
    • “Medicare and private insurers generally cover the cost of drugs like Ozempic when used to treat Type 2 diabetes but have been reluctant to pay for it when used for weight loss purposes. Several state and federal plaintiffs are trying to change that by claiming that obesity qualifies as a disability, and the exclusions violate discrimination laws.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity is declining nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The American Hospital News points out,
    • “There have been 712 confirmed cases of measles reported by 25 states so far this year, according to the latest figures released April 11 by the Centers for Disease Control and Prevention. The agency said 93% of those cases (660 of 712) are outbreak-associated and 11% of cases have been hospitalized. The vaccination status of 97% of cases is classified as “unvaccinated or unknown.”
  • ProPublic adds,
    • “In the past six months, two babies in Louisiana have died of pertussis, the disease commonly known as whooping cough.
    • “Washington state recently announced its first confirmed death from pertussis in more than a decade.
    • “Idaho and South Dakota each reported a death this year, and Oregon last year reported two as well as its highest number of cases since 1950.
    • “While much of the country is focused on the spiraling measles outbreak concentrated in the small, dusty towns of West Texas, cases of pertussis have skyrocketed by more than 1,500% nationwide since hitting a recent low in 2021 amid the COVID-19 pandemic. Deaths tied to the disease are also up, hitting 10 last year, compared with about two to four in previous years. Cases are on track to exceed that total this year.”
  • The New York Times reports,
    • “Surgeons removed a genetically engineered pig’s kidney from an Alabama woman after she experienced acute organ rejection, NYU Langone Health officials said on Friday.
    • “Towana Looney, 53, lived with the kidney for 130 days, which is longer than anyone else has tolerated an organ from a genetically modified animal. She has resumed dialysis, hospital officials said.
    • “Dr. Robert Montgomery, Ms. Looney’s surgeon and the director of the NYU Langone Transplant Institute, said that the so-called explant was not a setback for the field of xenotransplantation — the effort to use organs from animals to replace those that have failed in humans.
    • “This is the longest one of these organs has lasted,” he said in an interview, adding that Ms. Looney had other medical conditions that might have complicated her prognosis.
    • “All this takes time,” he said. “This game is going to be won by incremental improvements, singles and doubles, not trying to swing for the fences and get a home run.”
  • Health Day notes,
    • “About one in 10 U.S. adults with substance use disorder (SUD) report past-year hospitalizations, according to a research letter published online April 1 in the Annals of Internal Medicine.
    • “Eden Y. Bernstein, M.D., M.P.H., from the University of Colorado School of Medicine in Aurora, and colleagues described the prevalence of hospitalizations among U.S. adults with SUD. Adults were classified into non-mutually exclusive groups by presence of any SUD, individual SUD, and two or more SUDs. The proportion and number of U.S. adults who reported hospitalizations was estimated for each group.
    • “The researchers identified 60 million U.S. adults with SUD, of whom 5.8 million (9.7 percent) reported past-year hospitalizations. The proportion of hospitalized adults ranged from 7.3 to 23.6 percent among those with alcohol use disorder (AUD) and opioid use disorder (OUD), respectively. Among adults with SUD, those with versus without past-year hospitalizations were more likely to be older and more likely to have two or more medical comorbid conditions. Hospitalized adults with AUD, cannabis use disorder, and tobacco use disorder were also more likely to have serious mental illness. Across all groups apart from AUD, hospitalized adults were less likely to be uninsured. Hospitalized adults with OUD were less likely to be non-Hispanic Black.”
  • Per a National Cancer Institute news release,
    • “Why do some cancers come back many years after treatments had eliminated all signs of the disease? The answer may involve rogue cancer cells that spread to other parts of the body early in the disease and then enter a sleeping, or dormant, state, according to a growing body of research. 
    • “These dormant cancer cells can survive in the body undetected for months, years, or even decades, the research suggests. At some point, however, the cells may awaken and begin the process of forming metastatic tumors.  
    • “What causes disseminated cancer cells to enter, and then to leave, a dormant state is not known. 
    • “But recent studies of tumor dormancy have yielded clues that scientists believe could one day help them find ways to prevent metastases, which account for most cancer deaths.”
  • Genetic Engineering and Biotechnology News adds,
    • “Cancer vaccines have been a tantalizing idea for decades, but the vast complexity of the human immune system has posed significant challenges. Now, technological advances like rapid DNA sequencing, lymph node targeting, and AI-informed antigen selection are enabling the creation of precision vaccines that target cancers effectively while minimizing harmful side effects.”
  • AHRQ’s Effective Health Care Program shares a paper about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • The University of Minnesota’s CIDRAP relates,
    • “A new smartphone-sized device can deliver tuberculosis (TB) test results at the point of care in less than an hour, an innovation that could improve diagnosis of the deadly disease in settings in which access to healthcare facilities and lab equipment is limited, its Tulane University developers reported yesterday in Science Translational Medicine.
    • “Over 90% of new TB cases occur in low- and middle-income countries.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review calls attention to the fact that CMS has approved seven new health systems to offer hospital at home programs.
  • Beckers Payer Issues informs us,
    • “CVS Health has named Benjamin Kornitzer, MD, as Aetna’s chief medical officer. 
    • “Most recently, Dr. Kornitzer was chief medical officer at agilon health, a primary care physician services company primarily serving Medicare Advantage patients.
    • “He also previously served as CMO of Mount Sinai Health System in New York.”
  • Fierce Healthcare reports,
    • “A better consumer experience has implications for clinical improvements, according to a new report from CVS Health.
    • “The healthcare giant is putting a focus on innovation in this area, and to identify opportunities conducted an analysis that compared Net Promoter System (NPS) scores with clinical outcomes. It found that, for example, patients who were highly satisfied with the experience at their pharmacies were more likely to be adherent to their medications.
    • “The white paper notes that nonadherence to prescribed medications drives 16% of U.S. health spending each year, or about $500 billion.” 
  • Modern Healthcare tells us,
    • “Eli Lilly is partnering with digital health companies to boost sales of its weight loss medications.
    • “The drugmaker added hybrid weight loss startup Knownwell to its third-party marketplace of telehealth offerings earlier this month. Eli Lilly has also signed deals with Ro, Form Health and 9am Health.” 
  • BioPharma Dive recently updated its prescription drug patent tracker.
  • Bloomberg Law adds,
    • “Novo Nordisk A/S and Eli Lilly & Co. are using dense clusters of patents to extend monopolies on blockbuster diabetes and weight-loss drugs including Ozempic, Wegovy, and Mounjaro, fueling high prices and health inequities, according to an advocacy group report.
    • “The pharmaceutical companies’ adoption of a “financialized business model” prioritizes profits and shareholder returns through an aggressive strategy for securing additional patents for minor changes to extend their drugs’ market exclusivity well beyond the expiration of its original patents, according to a report released Thursday by the Initiative for Medicines, Access and Knowledge on “the heavy price” of those glucagon-like peptide 1 therapies.” * * *
    • In a statement Friday, Lilly said the “report is grossly inaccurate and includes patents that have nothing to do with tirzepatide.”
    • “To date, Lilly has only listed three patents in the Orange Book for” its two tirzepatide products, it added.
    • “Our business model is built on the fact that patents are limited in scope and duration, and when they expire, we welcome generic and biosimilar manufacturers to develop lower-cost alternatives,” the statement continued. “Lilly is already focused on developing the next innovation for patients that will eventually become generic.”
    • “The Orange Book is a US Food and Drug Administration registry listing patents that cover approved drugs that allows branded-drug makers to trigger a 30-month delay of FDA approval by filing a suit alleging infringement of a listed patent.
    • “Novo in a Friday statement said it has no more than four patents listed in the Orange Book for Ozempic , no more than eight for Wegovy, and 11 for Rybelsus.
    • “While the US healthcare system is complex and there are many factors that play a role in determining what people will pay for medicines,” Novo said, “the net price of Ozempic has declined by 40% since launch in the US and Wegovy is following a similar trajectory.”

Monday Report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • The Wall Street Journal reports,
    • “House Republicans’ moves to advance President Trump’s “one big, beautiful bill” this week have been cast into doubt by defections from GOP lawmakers worried that spending cuts are being pushed aside in a rush to enact tax reductions.
    • “Republican leaders want to vote on a fiscal framework that would unlock a fast track to legislation carrying many Trump priorities, including tax cuts and new spending on border security and the military. Trump and House Speaker Mike Johnson (R., La.) are hoping to show progress on extending expiring tax cuts to counteract the market chaos sparked in recent sessions by Trump’s tariff rollout.” 
  • and
    • The Trump administration will substantially increase payment rates for Medicare insurers next year, generating more than $25 billion in additional revenue for the industry and doubling the boost proposed in January.
    • The rate increase of 5.06%, compared with 2.23% in the earlier proposal from the Biden administration, overshoots even optimistic expectations from many Wall Street analysts, and will likely lead to a rally in the shares of big Medicare insurers such as UnitedHealth Group, Humana and CVS Health, parent of Aetna.
    • The Centers for Medicare and Medicaid Services announced the increase for 2026 payment rates on Monday. Investors are expected to view the bump as a sign of the Trump administration’s support for Medicare Advantage, the program under which private insurers administer the benefits of the federal program for older and disabled Americans. 
      The Medicare agency said the increase in the planned payment rate reflected rising medical costs, and that more recent data had led to the steeper final rise compared with the January proposal. 
  • Here are links to the CMS Medicare Advantage and Medicare D 2026 rate announcement, the related CMS fact sheet, and a CMS fact sheet about final 2026 Part D program redesign instructions:
    • “In CY 2026, the structure of the Part D benefit will be updated to reflect provisions of the IRA that become effective on January 1, 2026. The CY 2026 updates include the following:
    • “The CY 2026 annual out-of-pocket (OOP) threshold of $2,100, which is the original 2025 out-of-pocket cap of $2,000, adjusted based on the annual percentage increase in average expenditures for covered Part D drugs in the U.S. for Part D eligible individuals in the previous year (API).
    • “Changes to the liability of enrollees, sponsors, manufacturers, and CMS in the new standard Part D benefit design, specifically to account for the start of negotiated prices taking effect with respect to selected drugs for initial price applicability year 2026 under the Negotiation Program; and
    • “The establishment of the selected drug subsidy program.” * * *
    • “With the enhancements to the Part D benefit under the IRA, the current simplified determination methodology no longer reflects actuarial equivalence with defined standard Part D coverage. Accordingly, CMS has developed a revised simplified determination methodology that better reflects actuarial equivalence with the richer Part D defined standard benefit under the IRA. For CY 2026 only, non-RDS group health plans are permitted to use either the existing simplified determination methodology or the revised simplified determination methodology to determine whether their prescription drug coverage is creditable. Under the revised simplified determination methodology, the group health plan coverage must be designed to pay at least 72% of participants’ prescription drug expenses, versus 60% under the existing methodology.” 
  • In another surprising Medicare development, STAT News informs us,
    • “Medicare’s financial future unexpectedly got a lot rosier, at least according to some federal budget wonks. 
    • “The Congressional Budget Office recently published its long-term predictions of the federal budget and buried a big surprise for people who follow the Medicare program. The government’s primary piggy bank that pays for Medicare [Part A hospital and other facility] benefits won’t be depleted until 2052 — 17 years later than what CBO analysts predicted last year. 
    • “Quite a few responded they don’t believe it,” he said. “But they [CBO] do have their justification there. And of course this is a long-term projection, and a lot can change.”
  • The New York Times reports,
    • “Health Secretary Robert F. Kennedy Jr. kicked off a tour through southwestern states on Monday by calling on states to ban fluoride in drinking water supplies, a move that would reverse what some medical experts consider one of the most important public health practices in the country’s history.
    • “The announcement came at a news conference in Utah, the first state to enact such a ban into law. The state’s new law is set to take effect in early May, despite concerns from public health experts who consider fluoridation of water core to preventing tooth decay.
    • “It makes no sense to have it in our water supply,” Mr. Kennedy said, echoing a position he took during the 2024 presidential campaign. “I’m very, very proud of this state for being the first state to ban it, and I hope many more will come.”
    • “The Centers for Disease Control and Prevention, which Mr. Kennedy oversees as health secretary, has listed fluoridation as one of the 10 great public health achievements of the 20th century. After the news conference, Stefanie Spear, Mr. Kennedy’s principal deputy chief of staff, said Mr. Kennedy would direct the C.D.C.’s community preventative services task force to study fluoride and make a new recommendation.”
  • Per FedSmith,
    • “Retirement planning is a complex process for federal employees, requiring careful attention to eligibility rules and regulations. Among the many requirements that determine post-retirement benefits, the 5-year rule plays a crucial role in three key programs: Federal Employees Health Benefits (FEHB), Federal Employees’ Group Life Insurance (FEGLI), and Roth Thrift Savings Plan (Roth TSP). Understanding these rules can ensure a smooth transition into retirement while maintaining access to critical benefits.”
    • The article provides an understanding of these important rules.

From the judicial front,

  • Govexec relates,
    • “There’s a quorum again on the board that hears appeals of firings and suspensions of federal employees after a majority of judges on the U.S. Court of Appeals for the D.C. Circuit vacated an earlier decision that temporarily enabled President Donald Trump to remove a Democratic appointee to the Merit Systems Protection Board. 
    • “Trump in February attempted to fire Cathy Harris, a Biden appointee, from the MSPB. A district judge blocked the removal, but that order was paused on March 28 in a 2-1 decision by a three-judge panel of the D.C. Circuit while it heard the Trump administration’s appeal. 
    • “On Monday, however, a majority of D.C. circuit court judges overruled that decision through en banc reconsideration, which is a rare process that can be utilized if a litigant feels a circuit panel didn’t adhere to Supreme Court precedent. Such reconsideration involves all circuit judges who are in regular active service rather than the usual three-judge panel. 
    • “The circuit court judges were split 7-4 in granting the motion for en banc reconsideration. 
    • “At issue in this case is Humphrey’s Executor, a 1935 Supreme Court decision that found the president doesn’t have unfettered authority to remove officials on multimember, quasi-judicial bodies.” * * *
    • “Monday’s decision, as well as the overturned March 28 order, also apply to Gwynne Wilcox, a Biden appointee to the National Labor Relations Board who Trump similarly fired but who was later reinstated by a district court. 
    • “In a brief, lawyers for the Trump administration said they would seek emergency relief from the Supreme Court if Wilcox and Harris were allowed to return to their positions.”  
  • Bloomberg Law reports,
    • “A federal judge in Texas on Monday vacated a Biden administration rule that would have required about 75% of US nursing homes to add direct-care workers or face administrative penalties and fines.
    • “In his order granting a motion for summary judgment for the plaintiffs, the American Health Care Association, Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, said the nation’s nursing homes suffer from “failures,” including “inadequate staffing levels, poor infection control, failures in oversight and regulation, and deficiencies that result in actual patient harm.” All of which “deserve an effectual response,” he wrote.
    • “But any regulatory response must be consistent with Congress’s legislation governing nursing homes. The Final Rule’s challenged provisions are not,” Kacsmaryk declared of the varied requirements of the mandate, which included that facilities have a registered nurse on site around the clock. “Though the Final Rule attempts to remedy chronic nursing home deficiencies, it does so deficiently.” 
    • “Although “rooted in laudable goals, the Final Rule still must be consistent with Congress’s statutes,” Kacsmaryk added. “To allow otherwise permits agencies to amend statutes though they lack legislative power. Separation of powers demands more than praiseworthy intent.”

From the public health and medical research front,

  • The American Hospital Association News clarifies,
    • “A second Texas child died from measles April 3 amid an ongoing outbreak in the state, the Texas Department of State Health Services announced April 6. The child was not vaccinated and had no reported underlying conditions, the agency said. The latest death follows a child that died Feb. 26. An unvaccinated adult in New Mexico that died in March also tested positive for measles after their death, but measles was not confirmed as the official cause of death.”
  • The American Medical Association News lets us know what doctors wish their patients knew about improving their mental health.
  • Per MedPage Today,
    • “Biomarker and cognitive data supported treatment with the anti-amyloid agent lecanemab (Leqembi) for up to 36 months in early Alzheimer’s disease, initial findings from the CLARITY AD open-label extension study suggested.
    • “Continuous treatment led to greater changes in plasma amyloid-beta 42/40 levels, reported Christopher van Dyck, MD, of Yale University in New Haven, Connecticut, in a poster presented at the American Academy of Neurologyopens (AAN) annual meeting.” * * *
    • “Serious adverse events occurred in 20.5% of the total sample of 1,616 people in the core CLARITY AD trial and the open-label extension study who received lecanemab. Amyloid-related imaging abnormalities with edema (ARIA-E) occurred in 14.7%, ARIA with hemosiderin deposits (ARIA-H) occurred in 23.8%, and intracerebral hemorrhage (ICH) occurred in 0.7%. Three deaths concurrent with ARIA or ICH occurred.
    • “These findings provide the first evidence for a continued benefit of lecanemab and disease modification over the long term, out to 36 months,” van Dyck told MedPage Today.
    • “They also suggest that individuals with lower pathology — no or low tau, or low amyloid — experience a particularly robust stabilization of symptoms,” he continued. “These results collectively underscore the importance of early initiation and continued long-term treatment.”
  • and
    • “In a study of people without a history of cancer, comorbidities in midlife were associated with an overall risk of cancer.
    • “There was a stronger association between comorbidities and risk of multiple individual cancer types.
    • “The findings support the incorporation of formal comorbidity screening and/or risk assessment as a routine aspect of cancer screening visits.”
  • AHA News tells us,
    • “The National Institutes of Health April 7 released a study that found twins — smaller at birth on average than singletons — develop slower in early pregnancy than what was previously known. The ultrasound study found that twins have less fat tissue and muscle mass than singletons beginning at 15 weeks. Scientists believe the smaller size could be a way of adapting to accommodate more resources for two fetuses later in pregnancy. The NIH said confirmation of the findings in additional research could help guide physicians in monitoring and managing twin pregnancies.”
  • Per BioPharma Dive,
    • “Rhythm Pharmaceuticals on Monday said its drug for rare obesity conditions met the main goal of a Phase 3 clinical trial, helping people with weight gain triggered by brain injury lose about one-sixth of their body weight over one year of treatment.
    • The company plans to ask U.S. and European regulators to expand approval of the drug, called setmelanotide. The once-daily shot is marketed as Imcivree after being authorized in the U.S. in 2020 to treat people with genetically driven forms of obesity.
    • Imcivree earned $130 million in 2024 sales across its currently approved uses. Stifel analyst Paul Matteis wrote in a note to clients that the new indication is “a blockbuster opportunity with the potential for a fast ramp” in sales, adding that the weight loss data look “very strong.”

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Emergency department use has nearly recovered to prepandemic levels, but rising acuity, insufficient capacity and a laundry list of financial roadblocks are straining their viability and threatening patients’ access to care, according to a new report from RAND’s healthcare research arm.
    • “The nonprofit, nonpartisan organization’s nearly 200-page report (PDF)—sponsored by the Emergency Medicine Policy Institute (EMPI)—paints a distressing picture of the current state of EDs, which are among the few settings where patients receive 24/7 unscheduled acute care regardless of payment thanks to the federal Emergency Medical Treatment and Labor Act (EMTALA).
    • “EDs, the report notes, have lately faced more complex and sicker patients. Steady increases in demand and limited capacity have led to an increase in ED crowding (referred to as boarding), longer waits and potentially violence toward healthcare workers, which compromise care quality and emergency care worker attrition due to burnout. At the same time, EDs are providing more uncompensated care and expanding the scope of their work into specialties like geriatric care and care coordination.”
  • Per BioPharma Dive,
    • “Labcorp is now offering a blood-based biomarker test in the U.S. to support the diagnosis of Alzheimer’s disease.
    • “The immunoassay measures the ratio of ptau-217 and beta amyloid 42, two distinct biomarkers of Alzheimer’s, according to the Wednesday announcement. The Global CEO Initiative on Alzheimer’s Disease has called ptau-217 one the most promising blood-based biomarkers for amyloid status.
    • “Manufacturers of Alzheimer’s drugs have identified blood tests as a way to reduce the reliance on imaging and cerebrospinal fluid assays and to accelerate diagnosis and treatment.”
  • and
    • “GSK is betting potentially billions of dollars that a smaller drug company’s technology can help create new treatments for brain-corroding diseases.
    • “Through a licensing deal announced Sunday, GSK has gained access to drug delivery technology from South Korea’s ABL Bio. This “Grabody-B” platform is designed to shuttle medicines across arguably the trickiest obstacle in neuroscience — the blood-brain barrier or “BBB” — by using a protein that normally shepherds an important growth hormone across the divide.
    • “The platform had already caught the attention of another pharmaceutical giant, Sanofi, which in 2022 entered a collaboration with ABL to develop new therapies for diseases like Parkinson’s.”
  • KFF Health News tells us,
    • “Underscoring the massive scale of America’s medical debt problem, a New York-based nonprofit has struck a deal to pay off old medical bills for an estimated 20 million people.
    • “Undue Medical Debt, which buys patient debt, is retiring $30 billion worth of unpaid bills in a single transaction with Pendrick Capital Partners, a Virginia-based debt trading company. The average patient debt being retired is $1,100, according to the nonprofit, with some reaching the hundreds of thousands of dollars.
    • “The deal will prevent the debt being sold and protect millions of people from being targeted by collectors. But even proponents of retiring patient debt acknowledge that these deals cannot solve a crisis that now touches around 100 million people in the U.S.
    • “We don’t think that the way we finance health care is sustainable,” Undue Medical Debt chief executive Allison Sesso said in an interview with KFF Health News. “Medical debt has unreasonable expectations,” she said. “The people who owe the debts can’t pay.”
    • “In the past year alone, Americans borrowed an estimated $74 billion to pay for health care, a nationwide West Health-Gallup survey found. And even those who benefit from Undue’s debt relief may have other medical debt that won’t be relieved.
    • “This large purchase also highlights the challenges that debt collectors, hospitals, and other health care providers face as patients rack up big bills that aren’t covered by their health insurance.”

From the artificial intelligence front,

  • Modern Healthcare interviewed Pat Geraghty, Guidewell’s CEO, who discusses the use of AI in prior authorization approvals
    • “How do you educate consumers about the value of prior authorization? 
    • “There’s been a lot of noise around this topic recently. 
    • “We don’t want to come out and say, “let me just explain prior auth to you.” What we’re trying to do is say, “We know we can be better. We can use technology to help us be better. We can make the process quicker and smoother, and we’re going to do that and we’re committing to that.”
    • “We also want to be clear about the rest of the issues around prior auth. There is some clarification and explaining that is appropriate, but it’s not the lead thing. The lead thing is making sure we’re taking the hassle out of the process.
    • “How are you using technology to improve the process? 
    • “We use AI to say yes, not deny, and that allows us to get a very quick answer to the provider. We had 2.4 million authorizations last year that were done in just seconds. About 80% of our prior authorizations are on an automated basis.
    • “But the more complex the issue is, the more it really does involve the oversight of a clinician who understands the area that is being reviewed. You wouldn’t want to give up those kinds of dialogues. Oftentimes the discussions may end up with a modified treatment plan that’s best for all involved. It also is one of the ways we have a check on fraud, waste and abuse.
    • “The thing we find that drives the highest volume for denials is when a service is not covered by the health plan.”
  • The Washington Post reports, “AI is coming to skin cancer detection. Technology is already assisting with diagnoses, but experts predict better tools for non-experts will become available in the not-too-distant future.”

Happy National Employee Benefits Day!

David Ermer–ACA, CDC, Congress, FDA, NIH, Rx coverage, SCOTUS, U.S. Healthcare–

“National Employee Benefits Day is celebrated each year in April. The day recognizes trustees, administrators, benefits practitioners and professional advisors for their dedication to providing quality benefits and the important role they play in their colleagues’ well-being.”

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Republicans rallied behind a fiscal framework that allows more than $5 trillion in tax cuts over a decade, taking a crucial step toward turning President Trump’s agenda—tax cuts, border security and national defense—into law. 
    • “But the GOP budget resolution released Wednesday won’t be the final word along the complicated path to a major tax and spending bill. The plan employs a controversial accounting maneuver, postpones decisions about spending cuts and conflicts with a competing House plan. 
    • “The Senate is likely to vote on its budget later this week, but key House members are already objecting, warning that the Senate’s approach doesn’t guarantee the deep spending cuts they see as necessary.”
  • Modern Healthcare adds,
    • “The Senate Budget Committee unveiled a budget resolution Wednesday that could pave the way to less draconian cuts in health programs than House lawmakers previously proposed.
    • “The Senate proposal includes the House’s earlier recommendations that could lead to billions in health program cuts — but it also includes instructions for the Senate to go a different route while renewing tax cuts passed during President Donald Trump’s first term. The upper chamber’s resolution would delay sorting out differences with the House.
    • “The Senate’s budget resolution and negotiations with the lower chamber could provide for greater flexibility around healthcare cuts, which moderate Republicans in the House said they would not support if they were too steep. It also means the healthcare sector will have to wait to see what healthcare cuts — or spending — could be on tap until the Senate has done its work.”
  • Per a news release, “Today, Health, Employment, Labor, and Pensions Subcommittee of the House Education and Labor Committee held a hearing titled “A Healthy Workforce: Expanding Access and Affordability in Employer-Sponsored Health Care.”
  • Modern Healthcare points out,
    • “The Health and Human Services Department is restructuring agencies that enforce regulation, handle claims disputes, and investigate potential civil rights violations as part of a department-wide reorganization.
    • “A new assistant secretary for enforcement will oversee three parts of HHS — the Departmental Appeals Board, the Office of Medicare Hearings and Appeals and the Office of Civil Rights — as part of a sweeping overhaul announced last week. The new role raises questions about how HHS plans to handle billions of dollars in claims disputes and appeals resolutions, as well as how the offices will operate within the new structure. Healthcare attorneys are also watching for how HHS handles the operational elements of the reorganization, including staffing decisions and the chain of command at the affected offices.”
  • Fierce Healthcare lets us know,
    • “President Donald Trump made good on his threat of announcing new and steeper tariffs during a Wednesday afternoon White House event, setting the stage for higher prices and supply chain uncertainty for numerous industries including healthcare.
    • “The tariffs, set to go into effect at midnight, are the largest trade policy shift for the U.S. in decades and an end to the so-called free-trade era. They include a minimum 10% tariff that affects “all countries,” according to the White House. 
    • “Additionally, a slew of higher, individualized reciprocal tariffs will go into effect for dozens of countries with which the U.S. has a large trade deficit, the White House said. These are broadly designed to be around half of those imposed by most trade partners, including longtime allies.
    • “A 39% European Union tariff rate, for instance, will be matched by a 20% rate, the president explained. A 67% tariff imposed by China will see a reciprocal 34% tariff from the U.S.
    • “Pharmaceuticals are among a select list of goods that will not be subject to the higher reciprocal tariffs, according to a fact sheet released shortly after the signing ceremony and affirmed in the signed executive order. 
    • “The president also signed an order to close the “de minimis loophole,” a trade policy signed into law by Congress that allows shipments valued at less than $800 to be duty-free, for Chinese imports.”
  • Healthcare Dive points out,
    • “Enrollment in the Affordable Care Act marketplaces reached a new high in 2025, boosted by growth in states won by President Donald Trump in last year’s election, according to a research brief by KFF. 
    • “Sign-ups in the insurance marketplaces have more than doubled over the past five years, increasing from 11.4 million in 2020 to 24.3 million in 2025, the health policy research firm said Wednesday. 
    • “Much of the growth is linked to more generous federal financial assistance for the health plans first made available in 2021, according to KFF. But those enhanced premium subsidies are set to expire at the end of the year absent congressional action.”
  • The Wall Street Journal relates,
    • “Federal drug regulators have missed the deadline for making a key decision regarding a Covid-19 vaccine from Novavax, days after the Food and Drug Administration’s vaccine chief was pushed out.
    • “The agency was set to give full approval to Novavax’s shot, but senior leaders at the agency are now sitting on the decision and have said the Novavax application needed more data and was unlikely to be approved soon, people familiar with the matter said. 
    • ‘The FDA has allowed emergency use of Novavax’s Covid-19 vaccine. It set an April 1 deadline for a decision on whether to grant a normal, full approval, the people said.
    • “The decision would have cleared the vaccine’s continuing use though the pandemic emergency has passed. The FDA gave full approval to Covid-19 shots from Pfizer and its partner BioNTech and from Moderna in 2021 and 2022, respectively.
    • “Novavax said it is “continuing to communicate with the FDA and dialogue to ensure they have all the information required to complete our” application. 
    • “A Health and Human Services Department spokesman declined to comment. The FDA didn’t immediately respond to requests for comment.”

From the judicial front,

  • Bloomberg Law reports,
    • “Portions of a Tennessee law aimed at increasing pharmacy access are preempted by the federal employee benefits statute and can’t be enforced against certain self-funded employer health plans, a federal judge ruled.
    • “The law’s “any-willing-provider” requirement—which limits a plan’s ability to exclude pharmacies from its network—has an “impermissible connection” with benefit plans governed by the Employee Retirement Income Security Act, Judge Charles E. Atchley Jr. said Monday for the US District Court for the Eastern District of Tennessee. That’s because it dictates the scope of provider networks eliminates plans’ “discretion to shape benefits as they see fit,” he said.
    • “ERISA also preempts the Tennessee law’s prohibition on using financial incentives to promote or discourage use of a particular pharmacy, Atchley said, explaining that the law prevents ERISA-governed plans from “designing and providing benefits in a way that the plan determines best serves participants.”
    • “The decision is a victory for commercial bakery McKee Foods Corp., which initially filed suit to counter a campaign by defendant Thrifty Med Plus Pharmacy to be reinstated in the pharmacy network for McKee’s employee health plan.” * * *
    • “The case is McKee Foods Corp. v. BFP Inc., E.D. Tenn., No. 1:21-cv-00279, 3/31/25.”
  • The Wall Street Journal reports,
    • “The Federal Trade Commission’s [internal] lawsuit against three large pharmacy-benefit managers over insulin prices is on hold after President Trump fired two of the agency’s commissioners. 
    • “The FTC this week halted a lawsuit against the country’s largest drug middlemen, which negotiate drug prices for employers and insurers. The FTC said it needs to pause the litigation because its two remaining commissioners, both Republicans, are recused from the case, leaving none to oversee it.
    • “The antitrust enforcer in September 2024 sued Cigna’s Express Scripts, UnitedHealth Group’s Optum Rx and CVS Health’s CVS Caremark, accusing the firms of inflating the price of insulin. The lawsuit said firms profited by pocketing the discounts they had negotiated for the higher-priced insulin products they steered their customers to buy.
    • The FTC said in a court filing that the companies had agreed to put the case on hold for at least 105 days.”

From the public health and medical research front,

  • The AHA News informs us,
    • “A National Institutes of Health study published today found that blood pressure patterns observed during the first half of pregnancy can determine a woman’s risk of developing hypertension up to 14 years after giving birth. The study found that women showing certain blood pressure patterns during the first 20 weeks of pregnancy were more likely to develop hypertension years later. Researchers identified six risk groups of blood pressure trajectory that ranged from ultra-low to elevated-stable patterns. Women with elevated-stable patterns were at the highest risk.” 
  • Per Beckers Hospital Review,
    • “Lung cancer screening more than tripled after the U.S. Preventive Services Task Force expanded screening eligibility in 2021, according to a March 20 research letter published in JAMA Oncology.” * * *
    • “Read the full analysis here.” 
  • Nevertheless, MedPage Today cautions,
    • “Among eligible populations, screening for breast and colorectal cancers was nearly four times more common than for lung cancer.
    • “Among those who never had lung cancer screening, roughly 60% had undergone screening for breast and colorectal cancers.
    • “The findings suggest individuals eligible for low-dose CT screening may be receptive to efforts aimed at increasing uptake.”
  • Per Medscape,
    • “Two recent studies have added to the growing body of research suggesting consuming more dairy reduces a person’s risk of getting colorectal cancer.
    • “A prospective cohort study in Nature Communications published in January looked at the incidence of colorectal cancer (CRC) in more than 540,000 UK women over 16 years and found a 14% reduced risk for the cancer for every 200 g of dairy milk consumed per day. It also found an 8% reduced risk per 50 g of yogurt per day.
    • “The other study, from GutMicrobes, also published in January, looked specifically at yogurt intake with a focus on Bifidobacterium, a bacteria commonly found in yogurt. The researchers found that people who had at least two servings per week of yogurt had a 20% lower risk for Bifidobacterium-positive tumors than those who had less than one serving per month of yogurt, “suggesting the antitumor effect of yogurt intake on the specific tumor subgroup.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Jobs in the health insurance industry fell last year, something that hasn’t happened since 2009 and bucked an uptick in overall employment.
    • “It is a turning point for the industry, after years of profit growth and strategic expansions into pharmacy and provider businesses that increased headcount. Some of the largest publicly traded insurers reported steep workforce declines, according to a Modern Healthcare analysis of regulatory filings.
    • “Elevance Health, Humana, UnitedHealth Group and Centene cut their workforces, with the biggest reductions coming from the latter two companies. CVS Health and Molina Healthcare kept their workforce steady. Cigna grew its headcount nearly 1.4%.
    • “Across the seven companies, employment dipped 4.6% in 2024. Moreover, when not accounting for UnitedHealth Group, which reported a major reduction overseas, staffing among the other six still slipped 1.4%. National employment across all industries grew 1.2% last year, according to the Bureau of Labor Statistics.
    • “It was such a growth story for many years, and that’s tapered a little bit,” said Judy Busby, senior vice president and managing director of insurance staffing company The Jacobson Group.”
  • Per Beckers Hospital Review,
    • “Nonradiologists interpreted 43.6% of office-based imaging studies in 2022, according to a study published April 2 in the American Journal of Roentgenology. 
    • “Researchers from the Harvey L. Neiman Health Policy Institute analyzed more than 1.6 million Medicare physician office-based imaging claims ordered by nonradiologists. They found that just 36.4% of the studies were interpreted by a radiologist.” * * *
    • “For imaging type, nonradiologists interpreted 52% of ultrasound images, 5.3% of CT scans and 6.1% of MRIs. Smaller practices — those with one to nine providers — had a higher rate of self-interpretation than practices with 500 or more physicians.”Our results raise potential implications for quality of patient care,” Vijay Rao, MD, senior vice president of enterprise radiology at Philadelphia-based Jefferson Health and one of the study’s authors, said in a news release. “The large differences between radiologists and nonradiologists in interpretation training could lead to differences in diagnostic accuracy.”
  • Per MedTech Dive,
    • “Artis BioSolutions emerged from stealth Wednesday, announcing that it has acquired Landmark Bio, an alliance of academic institutions, hospitals and biotech companies founded in 2021 to help turn research ideas into broadly available genetic medicines.
    • “Landmark will continue to operate as a distinct entity, based in Watertown, Massachusetts. The acquisition by Artis BioSolutions will allow Landmark to scale up operations and “bring breakthrough therapies to more patients” Landmark CEO Ran Zheng said in a statement.
    • “Artis BioSolutions, backed by the venture capital firm Oak HC/FT, is now well positioned as a contract development and manufacturing organization for advanced therapies, the company said Wednesday. Artis BioSolutions said it can help customers speed up timelines, lower manufacturing costs and improve both product quality and supply chain management.”
  • The Wall Street Journal reports,
    • “Hims & Hers’s addition of obesity drug Zepbound won’t do much to bolster its weight-loss business, analysts say.
    • “Hims & Hers has been selling a compound GLP-1 for around $165 a month but will now offer the brand-name Zepbound for around $1,900 a month. Investors worry patients won’t make that price leap and that Hims, which has built its business on affordable healthcare, will struggle to meet its revenue goal.
    • “It’s probably unlikely that a compounded GLP-1 customer at Hims that’s paying $165 per month is going to transition to paying $1,900 per month for the fully branded,” Needham analyst Ryan MacDonald said. “There’s a question about how achievable the weight-loss revenue guidance is for 2025.”