Thursday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

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