FEHBlog

Wednesday Report

David Ermer–COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Mental health care, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network helpfully answers “common questions: about House Oversight Committee’s budget reconciliation cuts to federal and postal employee retirement benefits.
  • The Wall Street Journal reports,
    • “President Trump said he would nominate Casey Means, a California doctor and wellness influencer, to be the next surgeon general.
    • “Means has become more prominent with the rise of Health Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” movement. She and her brother, Kennedy adviser Calley Means, wrote a book, “Good Energy,” that became popular with Trump campaign staffers and later with Kennedy.
    • “Trump’s previous pick for the role, Dr. Janette Nesheiwat, was scheduled to face a Senate confirmation hearing later this week. Trump said she would work with Kennedy at HHS in a different role.”
  • Beckers Health IT adds,
    • “The FDA has appointed Jeremy Walsh as its first chief artificial intelligence officer, marking a step in tech modernization at the agency. 
    • “Mr. Walsh, who announced the career move in a May 2 LinkedIn post, will also oversee information technology in the role. 
    • “He joins the FDA after 14 years at government contractor Booz Allen Hamilton as a chief technologist, according to a May 6 report from Politico. In that role, Mr. Walsh developed cloud infrastructure and data analytics systems for agencies like the FDA, CDC, NIH, the Department of Veterans Affairs and military health services. 
    • “The appointment follows an April 3 directive from the Office of Management and Budget that stated each federal agency must appoint a chief AI officer within 60 days.”
  • Per BioPharma Dive,
    • “A panel of Food and Drug Administration advisers will meet May 22 to discuss updating the formula of COVID-19 vaccines ahead of the fall and winter season, according to a draft notice posted Wednesday.
    • “The Vaccines and Related Biological Products Advisory Committee will provide recommendations on selecting the specific coronavirus variant COVID vaccine manufacturers should target with booster shots. Their advice isn’t binding, but the FDA tends to follow it.”

From the public health and medical research front,

  • Beckers Hospital Review tells us that “U.S. News & World Report released its annual Best States rankings May 6, and Hawaii took the top spot for healthcare.”
  • The Los Angeles County, California, Department of Public Health “has declared a community-wide outbreak of hepatitis A following a sustained increase in clinical cases and elevated virus levels detected in local wastewater. Public Health confirmed 165 hepatitis A cases in LA County since 2024, which is three times the number of cases reported in 2023. Although unhoused individuals are at higher risk for contracting hepatitis A infection because they often have limited access to handwashing and toileting facilities, of the 29 hepatitis A cases confirmed to date in 2025, most have been among people without travel or housing risk factors. This increase in hepatitis A infections among people without risk factors has corresponded with recent increases in hepatitis A wastewater concentrations. While the risk to the general public remains low, community-wide protection actions are needed to ensure that transmission of hepatitis A is reduced.”
    • The County recommended vaccination against the disease for
      • “Any LA County resident who did not previously receive a hepatitis A vaccination and is seeking protection
      • “People experiencing homelessness
      • “People who use drugs (including non-injection).”
  • The National Cancer Institute lets us know that “A device that measures the “stickiness” of cancer cells in tumor samples may help predict the likelihood of a patient’s cancer metastasizing. Researchers believe the device could eventually help doctors make more informed treatment choices.”
  • Per Fierce Pharma,
    • Johnson & Johnson has generated evidence that the pace of oncology innovation is overwhelming physicians. A recent survey commissioned by the company found oncologists are struggling to keep up with new treatments and guidelines, pointing to a need for additional support to ensure patients get the most appropriate therapy.
    • Working with the Harris Poll, J&J surveyed 500 oncologists, urologists and advanced practice providers (APPs) across academic and community settings in the U.S. Three out of four oncologists said they find the pace of new drug development overwhelming. Around 70% of oncologists admitted they struggle to navigate the complexities of cancer treatment guidelines.
    • The survey suggests that continuing medical education helps, with 92% of oncologists agreeing it is crucial for providing cutting-edge treatments, but that more support is often needed. Extra support could help close the gap between the availability of new drugs and their successful implementation in clinical practice.
  • MedPage Today informs us,
    • “Fremanezumab (Ajovy) reduced depression symptoms and monthly migraine attacks in people with episodic or chronic migraine and major depressive disorder, the phase IV UNITE trial showed.
    • “The mean change from baseline in monthly migraine days during a 12-week double-blind period was -5.1 days (95% CI -6.09 to -4.13) with fremanezumab and -2.9 days (95% CI -3.89 to -1.96) with placebo (P<0.001), reported Richard Lipton, MD, of the Albert Einstein College of Medicine in New York City, and co-authors.”
  • Per Health Day,
    • “Patients with diverticulitis often try to control the digestive condition by cutting nuts, seeds and popcorn out of their daily diet.
    • “But that’s not necessary, a new study has found.
    • “Nuts and seeds do not increase the risk of diverticulitis, according to findings published May 5 in the Annals of Internal Medicine.
    • “Our findings refute the widely held belief that dietary intake of particulate matter [like nuts or seeds] should be avoided to prevent diverticulitis,” wrote the team led by senior researcher Dr. Anne Peery, a gastroenterologist with the University of North Carolina at Chapel Hill.
    • “However, people can lower their risk of diverticulitis by adopting one of four common health-focused diets, researchers found.
    • “We assessed diet quality and found that multiple healthy diet patterns were associated with a reduced risk for incident diverticulitis in women,” researchers wrote.”
  • Per Medscape,
    • “Lingering fatigue and depression are more common among women than men cancer survivors and often lead to a decrease in recreational physical activities in all patients, new data showed.
    • “However, moderate physical activity was linked to an almost 50% lower risk for cancer-related fatigue, and both moderate and vigorous physical activity were associated with a two- to fivefold reduced risk for depression among cancer survivors, according to the analysis presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.
    • “The findings “highlight the importance of providing special attention and tailored interventions such as exercise programs, support groups, and mind-body behavioral techniques for vulnerable groups to help effectively manage fatigue and improve participation in recreational activities as they are an essential aspect of quality of life,” Simo Du, MD, a resident at NYC Health + Hospitals and Jacobi Medical Center/Albert Einstein College of Medicine, New York City, said in a news release.”

From the U.S. healthcare business front,

  • Healthcare Finance reports,
    • “Hospitals across the U.S. are seeing both higher revenues and higher expenses, and operating margins have begun to contract slightly, according to March data published by Strata. 
    • “After holding steady at 1% in both January and February, operating margins for U.S. health systems narrowed slightly to 0.9% in March. Non-labor expenses rose faster than other expenses, due in part to double-digit increases in both drug and supply expenses versus the same month last year.
    • “Nationally, patient demand was up, with outpatient visits outpacing inpatient admissions. This compares with decreases in patient demand in February.
    • “Gross outpatient revenues led overall hospital revenue increases, jumping 10% year-over-year as hospitals and health systems continued to see care shift from inpatient to outpatient settings. 
    • “Per-physician expenses rose to $1.2 million in the first quarter, representing an increase of 3% from Q4 2024 and 10.3% from Q1 2024, data showed.”
  • Beckers Hospital Review adds, “Hospital margins had a slight increase in March despite significant patient volume declines, according to Kaufman Hall’s “National Hospital Flash Report” released May 7.”
  • Modern Healthcare relates,
    • “Cleveland Clinic and Regent Surgical are working together to build ambulatory surgery centers.
    • “The nonprofit health system and the ASC developer announced a joint venture Wednesday. Cleveland Clinic is the majority owner of the venture, which will feature the Cleveland, Ohio-based system’s brand, according to a news release. The system did not say how many facilities will be built or when they will open.”
  • Healthcare Dive points out,
    • “Northwell Health has completed its merger with Danbury, Connecticut-based Nuvance Health, the system said in a Wednesday press release.
    • “The deal officially closed May 1, after the systems received the final greenlight from Connecticut regulators last month.
    • “The merger creates a nearly $23 billion system, with 28 hospitals, 1,050 ambulatory care sites, 73 urgent care centers and more than 104,000 employees, according to the news release.
    • “Northwell President and CEO Michael Dowling will remain at the helm of Northwell and lead the combined system, according to a company spokesperson. Meanwhile, Nuvance President and CEO John Murphy will oversee Nuvance operations, reporting to Dowling.”
  • and
    • “One year has passed since Steward Health Care filed for bankruptcy, launching the largest healthcare provider restructuring in decades, including a monthslong effort to sell its 31 hospitals.
    • “Five Steward hospitals have permanently closed since its bankruptcy, while two more temporarily paused services. Many of the remaining facilities have landed back in the hands of private equity and investor owners, according to a new report from the Private Equity Stakeholder Project.
    • “The outlook for the hospitals is grim, after those that were “lucky enough not to close” were “simply punted from one investor-owned company to another, with little oversight or conditions from regulators to protect patients and community access to critical healthcare services,” the report says.”
  • Per MedCity News,
    • “Amyotrophic lateral sclerosis has been a tough area for drug research, but Eli Lilly has been spreading its bets in this neurodegenerative disease by striking deals with other companies. The pharmaceutical giant is adding to its stable of ALS drug candidates with a licensing agreement that brings a novel antibody on track to begin testing in humans.
    • “According to deal terms announced Tuesday, Lilly is licensing Alchemab’s ATLX-1282, an antibody that the companies say brings a first-in-class approach to ALS and other neurodegenerative diseases. Specific financial details were not disclosed, but Lilly is committing up to $415 million to its partner, which includes an upfront payment and milestone payments.”

Tuesday Report

David Ermer–CDC, FDA, Government Contracting, NIH, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Yesterday, according to the American Hospital Association News, the President signed an
    • “executive order, “Improving the Safety and Security of Biological Research,” orders the Director of the Office of Science and Technology Policy to immediately establish guidance for the heads of relevant agencies to end federal funding of gain-of-function research and other life-sciences research conducted by certain foreign entities. The order also directs OSTP to replace the “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” within 120 days and replace the “Framework for Nucleic Acid Synthesis Screening” within 90 days. The OSTP is also directed to establish a reporting mechanism for gain-of-function research.”
  • Science interviewed Dr. “Jay” Bhattacharya, the Director of the National Institutes for Health.
  • The Washington Post reports,
    • “Vinay Prasad, a critic of the Food and Drug Administration, has been tapped as the agency’s top regulator of vaccines, gene therapies and the blood supply.
    • “Prasad, a University of California at San Francisco professor and epidemiologist, will replace Peter Marks, whom the Trump administration forced out in late March. Prasad, who is also a hematologist and oncologist, is the latest vocal critic of pandemic-era policies to join the administration.
    • “He brings a great set of skills, energy, and competence to the FDA,” Marty Makary, the FDA commissioner, wrote Tuesday in an email to staff obtained by The Washington Post.”
  • and
    • “President Donald Trump and the U.S. Postal Service’s governing board are expected to name FedEx board member and former Waste Management CEO David Steiner as the nation’s next postmaster general, according to two people familiar with the decision, helping solidify the White House’s control over the historically independent mail service.
    • “Steiner replaces Louis DeJoy, whom Trump forced out of the role in March amid the mail chief’s clashes with billionaire Elon Musk’s U.S. DOGE Service and congressional dissatisfaction with the agency’s performance and finances, The Washington Post has reported. The people familiar with the decision spoke on the condition of anonymity to describe private conversations and meetings.
  • Govexec lets us know,
    • “The Trump administration is moving quick on its promise to conduct a massive overhaul of the Federal Acquisition Regulation, a project being called Revolutionary FAR Overhaul.
    • “FAR is the subject of one of two executive orders President Trump signed in mid-April to reform how the federal government buys goods and services.
    • “In documents released Friday, the administration is proposing the elimination of significant portions of the FAR. What would remain are only those provisions required by law or are “essential to sound procurement.” * * *
    • “The government is also asking for “informal” feedback on Part 34 ahead of the formal rulemaking process. Follow this link to share your thoughts.”
  • Per Federal News Network,
    • “Just over 7,800 federal employees retired last month, the lowest amount so far in 2025. The Office of Personnel Management said more than 33,500 federal employees retired in the first quarter of 2025 compared to 29,700 during the first three months of 2024. OPM’s retirement backlog dropped to 16,700, almost 4,000 less than March. On average, OPM is processing retirement claims in 54 days, but those applications that took less than 60 days for the agency to get OPM the paperwork were processed in 33 days on average.”
  • The Government Accountability Office released a WatchBlog post titled “Nonprofit Drug Companies Aim to Curb High Prices and Shortages.”
    • “The rising cost of prescription drugs continues to make headlines. This increase has significant implications for people who rely on medications and for taxpayer-funded health care programs. For example, Medicare spending on prescription drugs nearly doubled between 2014 and 2022.
    • “At the same time, the country has faced several drug shortages of medications ranging from antibiotics to chemotherapy drugs.
    • “Nonprofit drug companies could play a role in helping to address rising prices and drug shortages. Today’s WatchBlog post looks at our new report on nonprofit drug companies.”

From the public health and medical research front,

  • Your Local Epidemiologist, a Substack to which the FEHBlog subscribes, tells us,
    • “As of Sunday, the U.S. had 967 confirmed cases. We are getting closer and closer to reaching the record high (1,200) since we eliminated measles in 2000. 
    • “Of that, 817 cases are from the Southwest outbreak. The good news is that it may be slowing down in West Texas. We know this from three soft data points:
      • “This is the first week with no hospitalized children in West Texas for measles.
      • “A downward trend in reported weekly cases * * *. Ultimately, we want a bell-shaped curve, which may be starting to take shape.
      • “Fewer new cases are reported anecdotally by clinicians on the ground.”
    • “Transmission continues, just at a slower pace. While any case could still spark a new outbreak in communities with low vaccination rates (for example, all eyes are on El Paso right now), big thanks to the public health workers working to contain.”
  • MedPage Today informs us,
    • “During the first respiratory syncytial virus (RSV) season in which a maternal vaccine and a monoclonal antibody for infants were available, most infants were immunized via either intervention, according to an analysis of Vaccine Safety Datalink data.
    • “Overall, 72% of 36,949 infants were immunized in the 2023-2024 RSV season with either the bivalent RSV prefusion F protein vaccine (Abrysvo) or nirsevimab (Beyfortus), Stephanie Irving, MHS, of the Kaiser Permanente Center for Health Research in Portland, Oregon, and colleagues reported in Pediatrics.
    • “This really is a success story,” Irving told MedPage Today, “but it is important to also point out that more than a quarter of infants were not immunized against RSV.”
    • “The researchers also noted that there were disparities in access by race and ethnicity, with lowest uptake among Black (60.5%) and Middle Eastern/North African (60.2%) mothers. Rates were highest among Asian mothers (83.7%).”
  • CNN reports,
    • “Using marijuana during pregnancy is linked to poor fetal development, low infant birth weight, dangerously early deliveries and even death, according to a new meta-analysis of research.
    • “The most striking finding is the increased risk of perinatal mortality — death either during the pregnancy or shortly after the pregnancy,” said obstetrician and lead study author Dr. Jamie Lo, an associate professor of obstetrics, gynecology and urology in the School of Medicine at Oregon Health & Science University in Portland.
    • “Prior work we’ve done shows prenatal cannabis use impacts fetal lung function and development, reducing the baby’s lung volume,” Lo said. “We’ve also found that there is significantly decreased blood flow and oxygen availability in the placenta. These are the likely underlying mechanisms driving some of our findings.”
    • “The placenta is a critical link between the mother and the developing fetus, delivering oxygen, nutrients and hormones necessary for growth. When that link is damaged, both the mother and the fetus are at risk.”
  • The AP reports,
    • “A new salmonella outbreak linked to backyard poultry has sickened at least seven people in six states, health officials said Monday.
    • “Two cases were identified in Missouri, and one each in Florida, Illinois, South Dakota, Utah and Wisconsin, the Centers for Disease Control and Prevention said.
    • “People got sick in February and March of this year, the CDC said. They all had the same strain of salmonella — a version that has been traced to hatcheries in the past. The investigation is continuing, health officials said.
    • “Salmonella bacteria cause about 1.35 million infections in the United States every year, and recent outbreaks have been tied to sources such as cucumbers, eggs, unpasteurized milk, fresh basil, geckos and pet bearded dragons.
    • “But one concern is that chickens and other backyard poultry can carry salmonella bacteria even if they look healthy and clean. A backyard poultry-associated outbreak that ended last year was tied to 470 cases spread across 48 states, including one death.”
  • Beckers Hospital Review offers a list of “455 hospitals in the U.S. have a Clostridioides difficile infection rate of zero, as based on the healthcare-associated infections dataset from CMS.”
  • NIH Research Matters covers the following topics this week “Youth vaping drug | How nerves sense heat & pain | Non-hallucinogenic LSD analogue.”
  • Per Beckers Clinical Leadership,
    • “In a first-of-its-kind procedure, clinicians at the University of Maryland Medical Center in Baltimore removed a rare spinal tumor through a patient’s eye socket. 
    • “The patient, Karla Flores of Rosedale, Md., had two slow-growing developmental bone tumors in her spine and wrapped around her brain stem, according to the University of Maryland Medical System. The tumors, called chordomas, are rare and diagnosed only about 300 times annually in the U.S., the system said in a May 5 news release. 
    • “In two procedures, surgeons removed the tumor around the brain stem with a traditional craniotomy — through the skull — and with an endoscope through her nose. A team of neurosurgeons, radiation oncologists, and skull base and facial plastic surgeons contributed to Ms. Flores’ care.”
  • Health Day relates,
    • “An experimental drug might help people with uncontrolled high blood pressure, according to early clinical trial results.
    • “People taking lorundrostat experienced twice the decline in their systolic blood pressure than people taking a placebo, researchers reported recently in the New England Journal of Medicine. Systolic, the top number of a blood pressure reading, refers to the pressure within blood vessels during a heartbeat.
    • “While blood pressure readings remained elevated at the end of this Phase II trial in some participants treated with lorundrostat, we find these results promising because almost all participants involved in the study were not able to sufficiently lower their blood pressure with medication before,” principal investigator Dr. Michael Wilkinson, an associate professor with the University of California-San Diego School of Medicine, said in a news release.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us that “Each of the six major national insurers turned a profit in the first quarter of 2025, though financial pressures related to government programs—particularly Medicare Advantage (MA)—once again reared their ugly heads.”
  • Reuters relates,
    • “Bristol Myers Squibb (BMY.N), said on Monday it will invest $40 billion in the U.S. over the next five years, as it seeks to expand its research and manufacturing presence in the country amid U.S. President Donald Trump’s tariff threats.
    • “The announcement of new investment was first made by CEO Christopher Boerner in an opinion piece published in Stat News on Monday and was later confirmed to Reuters by a company spokesperson.”
  • STAT News adds,
    • “Vertex Pharmaceuticals on Monday reported disappointing first-quarter earnings impacted by weaker-than-expected sales of its drugs for cystic fibrosis, and little or no contributions from a gene therapy for sickle cell disease and a recently launched pain medicine. 
    • “A “tolerability issue” caused a temporary pause to an early stage study involving a closely watched, inhaled, mRNA-based therapy for cystic fibrosis, the company said.” 
  • Per Healthcare Dive,
    • “Rite Aid filed for bankruptcy on Monday, with plans to sell itself, and has already had “meaningful interest” from potential national and regional strategic buyers. Stores will remain open and operating, but plans are to liquidate all locations unless a buyer comes forward, according to court documents. 
    • ‘The drugstore retailer has secured commitments from some existing lenders to access $1.94 billion in new financing. That plus cash from operations is expected to be sufficient funding during the sale and court-supervised Chapter 11 process. 
    • “A sale is imminent, with an auction set for May 14 for the pharmacy assets and June 20 for other assets, per court documents. The company just exited a previous bankruptcy in September, after filing less than two years ago, emerging as a private business with about $2 billion less debt plus some $2.5 billion in exit financing.”
  • Per Healio,
    • “The FDA has approved a dihydroergotamine-based nasal powder for the acute treatment of migraine with or without aura in adults, according to the manufacturer. 
    • “In a press release, Satsuma Pharmaceuticals Inc. said that Atzumi, formerly known as STS101, is a proprietary product that combines an advanced nasal powder formulation of dihydroergotamine (DHE) and a novel nasal delivery device.
    • “Oral DHE has poor absorption, so other formulations are important for delivering the medication,” Abby Metzler, MD, associate professor of neurology at the University of Minnesota, told Healio. “This new nasal powder formulation adds another option that may help by providing a non-invasive option that is less likely to drip down the back of the throat into the stomach, increasing absorption of the medication.”
  • Outside of the U.S. STAT News lets us know,
    • “For more than three decades, a charity here has funded research aimed at developing medicines for genetic diseases. Recently, though, it added an unusual new role — as a gene therapy company of sorts. 
    • “The charity, the Telethon Foundation, took ownership from a small biotech of a drug that has been approved in Europe to treat an ultra-rare immune disorder called ADA-SCID. In taking such a step — something no nonprofit had done anywhere — it hoped to both rescue the gene therapy from disuse, and to come up with a new model for delivering these one-time, cutting-edge medicines in a financially sustainable way. 
    • “The fact that a charity — and not a biopharma company — now has the rights to the medicine is a reflection of the bleak situation the gene therapy field has found itself in, and how other groups, from nonprofits to academic researchers, are trying to mend the failures of the drug development system.” 

Monday Report

David Ermer–Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • STAT News reports,
    • “Amid ongoing anticipation over tariffs on pharmaceuticals, President Trump on Monday signed an executive order designed to lower regulatory hurdles and make it faster for drug companies to manufacture their products in the U.S. The move also includes plans to place more pressure on foreign drugmakers to comply with quality control inspections.
    • “At the top of the list is a mandate for the Food and Drug Administration to reduce the amount of time it takes to approve domestic pharmaceutical manufacturing plants. The agency is being directed to eliminate “duplicative and unnecessary requirements,” streamline reviews, and work with “domestic manufacturers to provide support before facilities start functioning.” Goals were not mentioned in the order.”
  • CMS announced,
    • “The Health Insurance Oversight System (HIOS) is now accepting RxDC submissions for the 2024 reference year.
    • “At this time, no training webinars have been scheduled. Previously published training materials are available on our website.
    • “The deadline for submitting RxDC filings for the 2024 reference year is Sunday, June 1, 2025.
  • Fierce Healthcare tells us,
    • “In June, the Centers for Medicare & Medicaid Services (CMS) will name the participating states for the agency’s new Cell and Gene Therapy (CGT) Access Model.
    • “One state has already started participating, the CMS said, and 35 states are agreeing to participating, reported Bloomberg. These states represent about 84% of Medicaid beneficiaries with sickle cell disease.
    • “Insurers, however, are wary broadly of the financial costs associated with cell and gene therapies, a report from the Pharmaceutical Strategies Group found. The report surveyed individuals on behalf of employers, health plans and unions.
    • “Nearly three-fourths (73%) of respondents said they view the affordability of cell and gene therapies as a moderate or major challenge in the next two to three years. For health plans, that figure rises to 87%. A majority (70%) of people said they were, at best, only somewhat confident they properly understood the financial impact of these therapies.”
  • Regulatory Focus informs us,
    • “Despite the rapid changes happening at the US Food and Drug Administration (FDA), the Michelle Tarver, director of the Center for Devices and Radiological Health (CDRH), said the device center is still meeting its goals and asked stakeholders to be patient as it works to fulfill its mission.
    • “Since President Donald Trump took office, FDA has lost thousands of its staffs to a combination of mass layoffs, buyout offers, and early retirements, with the most recent reduction-in-force (RIF) effort heavily affecting the agency’s communications, policy, and other non-review-related offices. Additionally, executive orders have limited the agency’s ability to issue new guidance and regulations without finding cost savings or trimming back other regulations. 
    • “Tarver made these remarks at the Medical Device Manufacturers Association (MDMA) Annual Meeting on 1 May. She noted that despite these changes, the agency is continuing to meet its expectations.”
  • The Solicitor General and Braidwood Management submitted their supplemental letter briefs on the legal authority of the Secretary of Health and Human Services to appoint members of the U.S. Preventive Services Task Force on schedule today. The Justices’ next conference is scheduled for May 15.

From the U.S. public health service front,

  • Health Dialogues points out,
    • “Unhealthy lifestyles are rapidly speeding up heart ageing, leading to a global surge in cardiovascular diseases, according to a study led by Indian-origin researchers in the UK. The research team from the University of East Anglia (UEA) used a novel Cardiac Magnetic Resonance (CMR) imaging technique also known as cardiovascular MRI to determine the “true age” of the heart.
    • “The scans showed that while healthy individuals had a heart age closely aligned with their actual age, those with conditions like Also Read – Tobacco and Marijuana Use Poised to Increase Heart Disease Deaths by 50% in Five Years diabetes, high blood pressure, obesity, and atrial fibrillation exhibited a significantly older functional heart age.
    • “For example, a 50-year-old with high blood pressure might have a heart that works like it’s 55,” said lead researcher Dr Pankaj Garg, from UEA’s Norwich Medical School and a consultant cardiologist at the Norfolk and Norwich University Hospital.
    • “People with health issues like diabetes or obesity often have hearts that are ageing faster than they should – sometimes by decades. So, this could help doctors step in early to stop heart disease in its tracks,” he added.”
  • The American Hospital Association News announced,
    • “In this conversation, Aaron Lewandowski, M.D., emergency medicine physician and the emergency medicine stroke representative at Henry Ford West Bloomfield Hospital, and Alex Chebl, M.D., interventional neurologist and director of the Henry Ford Stroke Center and the Division of Vascular Neurology at Henry Ford Health, discuss how artificial intelligence is revolutionizing stroke care. LISTEN NOW “
  • The American Medical Association lets us know what doctors wish their patients knew about Lyme disease.
  • Per Managed Healthcare Executive,
    • “Universal annual depression screening for young adults during primary care visits is cost-effective and could even save more if health systems improve access to telehealth, reduce treatment costs or enhance treatment effectiveness, according to a new study in JAMA Health Forum.“
  • The Washington Post reports,
    • “Nearly 10 percent of infants were admitted to a neonatal intensive care unit in the United States in 2023, according to a report from the National Center for Health Statistics, a 13 percent increase from admissions in 2016.
    • “The report drew on birth certificate data from the National Vital Statistics System, which includes detailed demographic and health information on mothers and infants for all U.S. births each year.”
    • Although not mentioned in the article, the FEHBlog expects that the increase is due to increase in the number of NICUs in the country, which is good development.
  • Consumer Reports, writing in the Washington Post, explains how to self-treat varicose veins.
  • Per Health Day,
    • “Boosting exercise in middle age might help people prevent Alzheimer’s disease, a new study says.
    • “People who increased their physical activity to meet recommended guidelines between ages 45 and 65 had less accumulation of amyloid beta, a toxic protein that forms plaques in the brains of Alzheimer’s patients, researchers reported April 30 in the journal Alzheimer’s & Dementia.
    • “The link was dose-dependent, researchers added — the more people increased their activity, the greater the reduction in amyloid beta in their brains.
    • “Active people also showed less age-related shrinkage in brain regions associated with memory and Alzheimer’s, researchers noted.
    • “Even those who did less physical activity than recommended had greater cortical thickness than sedentary people, suggesting that any amount of exercise, no matter how minimal, has health benefits,” lead investigator Müge Akinci, a researcher with the Barcelona Institute for Global Health in Spain, said in a news release.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Testing services company Labcorp has entered into an agreement to acquire certain clinical and anatomic pathology assets from Incyte Diagnostics, another testing company, as it seeks to expand its oncology portfolio. 
    • “Financial terms were not disclosed. Assets involved in the transaction include several Incyte Diagnostics same-day testing laboratories, its main anatomic pathology lab in Spokane, Washington, and additional labs in Tukwila and Richland, Washington, as well as Missoula, Montana.”
  • The Wall Street Journal notes,
    • “Hims & Hers Health HIMS 2.60%increase; green up pointing triangle first-quarter revenue more than doubled as subscribers rose 38%, while its second-quarter sales outlook missed Wall Street’s expectations.
    • “The stock fell 5% to $39.75 in after-hours trading on Monday. Shares have risen 73% year-to-date through Monday’s market close.
    • “The telehealth-consultation platform on Monday posted a profit of $49.5 million, or 20 cents a share, compared with $11.1 million, or 5 cents a share, a year earlier. Analysts polled by FactSet expected 12 cents a share.
    • “Revenue more than doubled to $586 million from $278.2 million a year ago. Analysts polled by FactSet expected $538.6 million.
    • “The San Francisco-based company now has almost 2.4 million subscribers, up 38% from the year-ago period. Average monthly online revenue per subscriber rose to $84 from $55.” * * *
    • “Hims earlier Monday named a former Amazon.com executive, Nader Kabbani, as its chief operating officer, an appointment that comes as the company is looking to expand access to its offerings, which currently includes treatments for sexual health, hair loss and weight management. While at Amazon, Kabbani led the launch of the online retailer’s pharmacy business and acquisition of PillPack, which presorts medications and ships them to homes.”
  • Beckers Payer Issues ranks large payers by 1st quarter 2025 profits.
  • Beckers Hospital Review lists six drugs currently in shortage.

Weekend update

David Ermer–Congress, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Roll Call offers a summary of this week’s activities on Capitol Hill.
  • Bloomberg Law explains that House Oversight Committee “Benefits reductions [approved last Wednesday] will next go before the House Budget Committee, which is tasked with assembling bills into a reconciliation package that will have to be approved by the House and Senate.”
  • In a Federal News Network commentary, an OPM executive from the Obama and Biden administrations criticizes the Trump Administration for allowing carrier more flexibility in managing GLP-1 drug coverage for obesity. The FEHBlog agrees with OPM’s decision because carriers hold the financial risk for their respective FEHB plans. That is quite an incentive to sensibly manage benefits.
  • In any case, this criticism is surprising because the Biden administration caused FEHB premiums to explode, in the FEHBlog’s opinion, by mandating coverage of GLP-1 drugs for obesity in January 2023 without allowing carriers to adjust premiums until the following January. While federal government procurement law permits OPM to make unilateral contract amendments, OPM is obligated to provide the contractor with a concurrent equitable price adjustment. All price adjustments in the FEHB are made through the benefit and rate negotiation process. Consequently, all benefit mandates must be run through that process.
  • HR Dive tells us,
    • “Field staff for the U.S. Department of Labor’s Wage and Hour Division will not apply the agency’s 2024 independent contractor rule in their enforcement of the Fair Labor Standards Act, a DOL bulletin announced Thursday.
    • “Instead, the department directed staff to apply a 2008 fact sheet as well as a 2019 opinion letter to any matters in which no payments for back pay or civil monetary penalties have been made to either individuals or DOL.
    • “The agency said it is still considering rescinding the Biden administration’s rule, which faces ongoing litigation. “Until further action is taken, the 2024 Rule remains in effect for purposes of private litigation and nothing in this Field Assistance Bulletin changes the rights of employees or responsibilities of employers under the FLSA,” DOL noted.”
  • and
    • “U.S. Department of Justice attorneys asked the 5th U.S. Circuit Court of Appeals to temporarily suspend the Labor Department’s appeals in two cases challenging its 2024 Fair Labor Standards Act overtime rule, according to an April 24 court filing.
    • “Texas district court judges twice blocked DOL’s final rule, which increased the minimum salary threshold for overtime pay eligibility in two steps. First, a November 2024 decision sided with plaintiffs including the state of Texas and enjoined the rule nationwide. A second judgment set aside and vacated the rule in response to a lawsuit by marketing agency Flint Avenue.
    • “The government asked that the 5th Circuit place its appeals in abeyance “pending the agency’s reconsideration of the rule.” It said counsel for the appellees in both cases did not oppose its request.”

From the public health and medical research front,

  • NPR Shots lets us know,
    • “Older Americans want to know if they are in the early stages of Alzheimer’s disease and would happily take a blood test to find out, according to a national survey.
    • “The survey of 1,700 people 45 and older, part of a report from the Alzheimer’s Association, found growing interest in testing, diagnosis and treatment for the deadly disease.” * * *
    • “The responses show that people are becoming less afraid and more proactive about an Alzheimer’s diagnosis, says Elizabeth Edgerly, a clinical psychologist who directs community programs for the Alzheimer’s Association.”

Per the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “The threat of tariffs on pharmaceuticals imported to the U.S. hasn’t yet pushed drugmakers off course, with many of the largest companies indicating they expect to be able to absorb any impact in the short term.
    • “Speaking on earnings calls in recent weeks, pharma executives have, for the most part, told investors their supply chains are flexible enough to mitigate the effects of new levies — for this year, at least. With a few exceptions, the large drugmakers that have reported financials for the first quarter are maintaining their sales and profit guidance for 2025.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity and law enforcement front,

  • Cyberscoop reports,
    • “Homeland Security Secretary Kristi Noem outlined her plans Tuesday to refocus the Cybersecurity and Infrastructure Security Agency (CISA) on protecting critical infrastructure from increasingly sophisticated threats — particularly from China — while distancing the agency from what she characterized as mission drift under previous leadership.
    • “Speaking at the 2025 RSAC Conference, Noem provided the most detailed vision yet of how the current administration is pushing CISA to a “back-to-basics” approach aimed at hardening defenses against adversaries who have demonstrated capabilities to infiltrate critical systems.”
  • and
    • “Threat intelligence sharing is flowing between the private sector and federal government and remains unimpeded thus far by job losses and budget cuts across federal agencies that support the cyber mission, according to executives at major security firms.
    • “Top brass at Amazon, CrowdStrike, Google and Palo Alto Networks said there’s been no change to interactions with the federal government since President Donald Trump was inaugurated earlier this year.
    • “Across multiple interviews and media briefings during the RSAC 2025 Conference this week, none of the leaders at these top cybersecurity companies conveyed any concern about or experience with communication breakdowns. Each of them dismissed the idea that collaboration has slowed down amid significant workforce reductions and strategic changes across the federal government.”
  • Earlier this week, the National Institute of Standards and Technology released its FY 2024 Cybersecurity & Privacy Program Annual Report.
  • Federal News Network tells us,
    • “While much of the cybersecurity community’s attention was out west at the annual RSA Conference, the Justice Department announced yet another settlement in its pursuit of contractors who falsely attest to meeting cybersecurity requirements.
    • “DoJ announced today that Raytheon Company, RTX Corporation and Nightwing Group have agreed to pay $8.3 million to settle allegations that Raytheon violated the False Claims Act by falling short of contractually mandated cybersecurity standards.
    • “RTX sold its cybersecurity, intelligence and services business to Nightwing in 2024. DoJ’s case centered on conduct between 2015 and 2021, prior to the acquisition.
    • “The case is another feather in the cap for DoJ’s Civil-Cyber Fraud Initiative. Started under the Biden administration, the goal of the initiative is to enforce cybersecurity requirements that many contractors had been ignoring through the False Claims Act.”
  • Per the Hacker News,
    • “The U.S. Department of Justice (DoJ) on Thursday announced charges against a 36-year-old Yemeni national for allegedly deploying the Black Kingdom ransomware against global targets, including businesses, schools, and hospitals in the United States.
    • “Rami Khaled Ahmed of Sana’a, Yemen, has been charged with one count of conspiracy, one count of intentional damage to a protected computer, and one count of threatening damage to a protected computer. Ahmed is assessed to be currently living in Yemen.
    • “From March 2021 to June 2023, Ahmed and others infected computer networks of several U.S.-based victims, including a medical billing services company in Encino, a ski resort in Oregon, a school district in Pennsylvania, and a health clinic in Wisconsin,” the DoJ said in a statement.”
  • Cyberscoop adds,
    • “Federal authorities extradited a Ukrainian citizen to the United States on Wednesday to face charges for participating in a series of ransomware cyberattacks on organizations based in the U.S. and multiple European countries. 
    • “Artem Stryzhak, 35, was arrested in Spain in June 2024 and was scheduled to appear for arraignment Thursday in the U.S. District Court for the Eastern District of New York. Stryzhak is accused of conspiracy to commit fraud and related activity, including extortion.
    • “Prosecutors accuse Stryzhak and his co-conspirators of using Nefilim ransomware to encrypt computer networks in the U.S., Canada, France, Germany, Australia, the Netherlands, Norway and Switzerland between late 2018 to late 2021.
    • “As alleged, the defendant was part of an international ransomware scheme in which he conspired to target high-revenue companies in the United States, steal data, and hold data hostage in exchange for payment. If victims did not pay, the criminals then leaked the data online,” John Durham, U.S. attorney for the Eastern District of New York, said in a statement.”

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive reports,
    • “Hackers are increasingly using AI in their attacks and defenders should follow suit, Check Point Software Technologies said in a report published Wednesday.
    • “The company’s AI security report, announced at the 2025 RSAC Conference in San Francisco, also found that one in 13 generative AI prompts contained potentially sensitive information, and one in every 80 prompts posed “a high risk of sensitive data leakage.”
    • “Unauthorized AI tools, data loss, and AI platform vulnerabilities topped the list of AI risks for enterprises, according to Check Point.”
  • and
    • “In a report published Tuesday, Google said it saw hackers exploit fewer zero-day vulnerabilities in the wild in 2024 than in 2023.
    • “The company attributed the decrease to improvements in secure software development practices.
    • “Still, Google said it is seeing a “slow but steady” increase in the rate of zero-day exploitation over time.”
  • CISA added eight known exploited vulnerabilities to its catalog this week.
  • “April 28, 2025
    • “CVE-2025-1976 Broadcom Brocade Fabric OS Code Injection Vulnerability
    • “CVE-2025-42599 Qualitia Active! Mail Stack-Based Buffer Overflow Vulnerability
    • “CVE-2025-3928 Commvault Web Server Unspecified Vulnerability”
    • Bleeping Computer discusses these KVEs here.
  • “April 29, 2025
    • “CVE-2025-31324 SAP NetWeaver Unrestricted File Upload Vulnerability”
    • Cybersecurity Dive discusses this KVE here.
  • “May 1, 2025
    • “CVE-2024-38475 Apache HTTP Server Improper Escaping of Output Vulnerability
    • “CVE-2023-44221 SonicWall SMA100 Appliances OS Command Injection Vulnerability
    • Cybersecurity News discusses the Apache KVE here.
    • Bleeping Computer discusses the SonicWall KVE here.
  • “May 2, 2025
    • “CVE-2025-34028 Commvault Command Center Path Traversal Vulnerability
    • “CVE-2024-58136 Yiiframework Yii Improper Protection of Alternate Path Vulnerability”
    • Security Affairs discusses these KVEs here.

From the ransomware front,

  • Techradar points out,
    • New research has revealed the scale of recent ransomware revolution, warning it remains a dominant threat to organizations worldwide.
    • A Veeam study, which gathered insights from 1,300 CISOs, IT leaders, and security professionals across the Americas, Europe, and Australia, found nearly three-quarters of businesses were impacted by ransomware over the past year.
    • Cybersecurity measures seem to be having some effect, with businesses facing ransomware incidents dropping slightly from 75% to 69% – and ransomware payments are also decreasing, as in 2024, 36% of affected businesses chose not to pay, and 60% of those who did paid less than half of the demanded ransom.
  • Dark Reading adds,
    • “Several high-profile retailers based in the UK have suffered cyberattacks in recent weeks, and all signs point to two possible threat actors being behind the campaign.
    • “The National Cyber Security Centre (NCSC), the UK’s primary cyber agency, said on May 1 that it was tracking a series of attacks impacting retailers. NCSC CEO Dr. Richard Horne said in an included statement that the agency was working with affected organizations and that “these incidents should act as a wake-up call to all organizations.”
    • “Co-Op, Marks & Spencer, and Harrods are among the retailers that have confirmed attacks in recent weeks. In an article published May 2, Bloomberg News reported a spokesperson for the DragonForce ransomware gang — a group that emerged as a ransomware-as-a-service (RaaS) player in 2023 — took credit for the attacks against all three retailers.
    • “Last month, researchers from Sophos’ Secureworks reported that DragonForce had an RaaS model where affiliates could create their own “brand,” using DragonForce’s ransomware or using their own tools for extortion attacks.”
  • and
    • “The notorious Scattered Spider threat group continues to attack high-value targets despite landing on the receiving end of multiple global law enforcement operations.
    • “Scattered Spider gained notoriety in recent years with high-profile breaches and ransomware attacks against large enterprises, including Las Vegas casino and hotel giants Caesars Entertainment and MGM Resorts in 2023. First emerging in 2022, the group’s members displayed a knack for social engineering schemes that allowed them to steal credentials from targeted organizations and gain privileged access into their networks. * * *
    • Bleeping Computer this week reported that the cyberattack against British retail giant Marks & Spencer was perpetrated by members of the group using DragonForce ransomware. Earlier this month, threat intelligence vendor Silent Push said it had observed significant threat activity, specifically phishing campaigns targeting well-known brands this year, from Chick-fil-A to Louis Vuitton.
  • and
    • “RansomHub, an aggressive ransomware-as-a-service (RaaS) operation that gained prominence over the past year in the wake of law enforcement actions against LockBit and ALPHV, appears to have abruptly gone dark earlier this month.
    • “In a new report this week that offers an in-depth look at RansomHub’s affiliate recruitment methods, negotiation tactics, and aggressive extortion strategies, researchers at Group-IB described the operation as inactive since April 1.
    • “Cybercriminals associated with the operation may have migrated to the Russian-language speaking Qilin RaaS operation and are continuing their attacks under that banner, Group-IB said. The security vendor did not offer any explanation for the rapidly growing RansomHub operation’s seemingly sudden and unexpected demise — if that is indeed what it is.”
  • TechTarget offers a “look at the [seven] distinct stages of the ransomware lifecycle to better understand how attackers strike — and how defenders might be better able to resist.

From the cybersecurity defense front,

  • Cyberscoop reports
    • “Leaders of various federal research agencies and departments outlined a vision Tuesday for the future of critical infrastructure security, emphasizing the promise of combining formal software development methods with large language models (LLMs). 
    • “Acting DARPA Director Rob McHenry told an audience at the RSAC 2025 Conference that such a combination could “virtually eliminate software vulnerabilities” across foundational system infrastructures, a departure from the traditionally accepted risks of software flaws.
    • “We’ve all been trained in a world where we have to accept that there are vulnerabilities in our software, and bad guys exploit those vulnerabilities,” he said. “We try to mitigate the damage and patch them, and we go round on this merry-go-round. That technologically does not need to be true anymore.”
    • “DARPA’s statements came in the context of the AI Cyber Challenge, a public-private collaboration involving industry leaders such as Google, Microsoft, Anthropic and OpenAI. The initiative tests whether advanced AI systems can identify and patch vulnerabilities in open-source software components vital to the electric grid, health care, and transportation.”
  • and
    • “Cryptography experts say the race to fend off future quantum-computer attacks has entered a decisive but measured phase, with companies quietly replacing the internet plumbing that the majority of the industry once considered unbreakable.
    • “Speaking at Cloudflare’s Trust Forward Summit on Wednesday, encryption leaders at IBM Research, Amazon Web Services and Cloudflare outlined how organizations are refitting cryptographic tools that safeguard online banking, medical data and government communications. The aim is to stay ahead of quantum machines that, once powerful enough, could decode the math protecting today’s digital traffic.
    • “Over the next five to 10 years you’re going to see a Cambrian explosion of different cryptographic systems,” said Wesley Evans, a product manager for Cloudflare’s research team, referring to an evolutionary period with a rapid diversification of animal life that occurred roughly 540 million years ago.” 
  • Dark Reading adds,
    • “Each year, top SANS faculty joins the RSAC conference to present what their community of practitioners and researchers see as the most pressing challenges facing the cybersecurity community for the year to come. This year’s list of top-five threats aren’t merely technical, and tackling them will demand coordinated leadership from the very top of the organization and beyond.
    • “The attack techniques outlined in the SANS RSAC 2025 keynote underscore a common theme: Cybersecurity is no longer confined to the security operations center — it’s a leadership issue that impacts every layer of the enterprise,” according to a SANS media statement. “The threats of tomorrow demand a strategic, integrated response rooted in visibility, agility, and cross-functional alignment.”
  • Bleeping Computer notes,
    • “Microsoft has announced that all new Microsoft accounts will be “passwordless by default” to secure them against password attacks such as phishing, brute force, and credential stuffing.
    • “The announcement comes after the company started rolling out updated sign-in and sign-up user experience (UX) flows for web and mobile apps in March, optimized for passwordless and passkey-first authentication.
    • “As part of this simplified UX, we’re changing the default behavior for new accounts. Brand new Microsoft accounts will now be ‘passwordless by default’,” said Joy Chik, Microsoft’s President for Identity & Network Access, and Vasu Jakkal, Corporate Vice President for Microsoft Security.”
  • Here is a link to Dark Reading’s CISO Corner.

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.”

Thursday Report

David Ermer–ACA, AHRQ, CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Medicare, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Senate has adjourned until next Monday with no sign of when the President’s nominee for OPM Director Scott Kupor will receive floor consideration. According to the Senate Executive Calendar, there are many nominees besides Mr. Kupor patiently waiting their turn.
  • Federal News Network offers an article about Wednesday’s House Oversight Committee markup and passage of its budget resolution.
  • Per a Senate press release,
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, applauded the U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) announcement of Generation Gold Standard, a new initiative to pursue a universal vaccine platform for viruses that are most likely to cause pandemics. HHS Secretary Kennedy and NIH Director Bhattacharya announced the initiative to protect people against multiple strains of widely contagious viruses through a beta-propiolactone (BPL)-inactivated, whole-virus platform.  
    • “Scientists have long considered universal vaccines as the Holy Grail solution to protect Americans from quickly mutating viruses,” said Dr. Cassidy. “I am glad that Secretary Kennedy and the Trump administration are prioritizing this important area of research so we can be better prepared to tackle tomorrow’s health threats.”
    • “According to HHS, the clinical trials for universal influenza vaccines are scheduled to begin in 2026, with Food and Drug Administration (FDA) approval targeted for 2029. The intranasal BPL-1357 flu vaccine, currently in advanced trials, is also on track for FDA review by 2029.”  
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services, through the Office of the Assistant Secretary for Health and Office of Population Affairs, released a comprehensive review, opens in a new tab of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria. This review, informed by an evidence-based medicine approach, reveals serious concerns about medical interventions, such as puberty blockers, cross-sex hormones, and surgeries, that attempt to transition children and adolescents away from their sex.
    • “The review highlights a growing body of evidence pointing to significant risks—including irreversible harms such as infertility—while finding very weak evidence of benefit. That weakness has been a consistent finding of systematic reviews of evidence around the world.
    • “The review also fills a gap in the medical literature and existing clinical practice reviews with regard to the ethical aspects of pediatric medical transition. HHS believes that medical ethics should be central in this debate.”
  • The Internal Revenue Service announced
    • SECTION 2. 2026 INFLATION ADJUSTED ITEMS
      • “.01 Health Savings Account Inflation Adjusted Items.
        • “(1) Annual contribution limitation. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(A) for an individual with self-only coverage under a high– deductible health plan is $4,400. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(B) for an individual with family coverage under a high deductible health plan is $8,750.
        • “(2) High deductible health plan. For calendar year 2026, a “high deductible health plan” is defined under § 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,700 for self-only coverage or $3,400 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,500 for self-only coverage or $17,000 for family coverage.”
  • OPM proposed a new rule
    • “The Office of Personnel Management (OPM) is proposing to remove the prohibition of a forced distribution of performance rating levels within the Senior Executive Service (SES) as well as eliminate diversity, equity, and inclusion (DEI) language within SES performance management regulations. Currently, agencies are prohibited from establishing quotas or limits on the number or proportion of the various rating levels assigned, meaning that each senior executive potentially can receive any rating based on their performance, irrespective of how other senior executives perform within the agency. However, governmentwide SES ratings data have consistently shown that virtually all SES receive the highest rating levels (i.e., levels 4 and 5) despite documented reports of SES failings. Removing the prohibition on forced distribution would allow agencies to establish and enforce limits on the highest SES rating levels, thereby increasing rigor in the SES appraisal process and leading to a more normalized distribution of SES ratings across the Federal Government.”
    • The FEHBlog estimates that the public comment period will end on June 2, 2025.
  • Tammy Flanagan, writing in Govexec, provides “a crash course in retirement planning. Let’s revisit my tips and resources for transitioning from employee to annuitant.”
  • Fierce Healthcare lets us know,
    • The Centers for Medicare & Medicaid Services (CMS) has launched the Fraud Detection Operation Center (FDOC) to fight waste, fraud and abuse, the agency announced this week.
    • Listed on a new webpage are a list of “recent success stories.” They include taking action against improper enrollment in Affordable Care Act (ACA) plans, cracking down on false billing of wound care services and scrutinizing “problematic activities” regarding hospice claims.
    • The page also claims it stopped payments to a provider who died 20 years ago as well removed 18 providers convicted of a “serious crime” for not meeting adequate standards.” ***
    • “The FDOC leverages the Fraud Prevention System (FPS), a system developed, built and operated by federal contractor Peraton. The FPS uses artificial intelligence and machine learning models to flag potentially fraudulent behavior by providers, allowing investigators to more easily see whether a provider should be funneled to the government’s case management system.”

From the Food and Drug Administration front,

  • Fierce Pharma tells us,
    • “Amid a slew of recent shake-ups at the FDA—including the agency’s reduction in force and high-profile leadership exits—the regulator is ushering in “radical” changes to how it signs off on new vaccines.
    • “Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN. 
    • “It isn’t immediately clear which “new” vaccines will be affected by the policy. Flu and COVID-19 vaccine shots are updated annually to match the latest strains and variants, so manufacturers do indeed roll out new shots based on their existing platforms. For novel vaccines against completely new viral targets, placebo testing is a regular part of the R&D and regulatory review process.” * * *
  • Per BioPharma Dive,
    • “The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines may face additional regulatory scrutiny under new agency leadership.
    • “Alongside first quarter earnings Thursday, the biotechnology company said a U.S. approval decision previously expected this year may now occur in 2026. Moderna filed for approval in 2024 based on a late-stage study showing the shot sparked immune responses against both viruses in adults 50 years of age or older. But the FDA has communicated that it will require Phase 3 flu efficacy data before issuing a clearance, Moderna said.”

From the judicial front,

  • Healthcare Dive reports,
    • “The Department of Justice is accusing three of the largest health insurers in the U.S. of paying brokers kickbacks for enrolling seniors in their Medicare Advantage plans.
    • “CVS unit Aetna, Elevance and Humana paid brokers eHealth, GoHealth and SelectQuote hundreds of millions of dollars in return for signing people up for their MA coverage from 2016 to 2021 — regardless of the plans’ suitability for those members’ needs, according to the DOJ’s complaint filed Thursday.
    • “Spokespeople for Humana and CVS said the companies are reviewing the DOJ’s complaint and did not provide detailed comment for this story, though CVS said it disagrees with the allegations. Elevance did not respond to a request for comment.”

From the public health and medical research front,

  • CBS News reports,
    • “Diabetes deaths in the U.S. have fallen to some of the lowest rates in years, according to new preliminary figures published by the Centers for Disease Control and Prevention, reversing a surge in mortality that was seen during the COVID-19 pandemic.
    • “There were 26.4 deaths per 100,000 people from diabetes, according to early death certificate data for the third quarter of 2024 published this month by the CDC’s National Center for Health Statistics. 
    • “Death rates from diabetes peaked in 2021, according to CDC figures, at 31.1 deaths per 100,000 people for that year. Diabetes was the eighth leading cause of death in 2021. The CDC says the link between COVID-19 and diabetes may be to blame for that increase. 
    • “Data show an increase in mortality rates for all people during the COVID-19 pandemic, and research shows that people with underlying conditions, including diabetes, are more likely to become very sick from COVID-19 and have a higher risk of hospitalization and death,” Christopher Holliday, head of the CDC’s Division of Diabetes Translation, told CBS News in a statement.
    • “Holliday added that research shows the pandemic may also have made it harder for Americans to properly manage the disease, ranging from interruptions to physical activity to disruptions to routine medical care diagnosing and treating the disease.”
  • MedPage Today adds,
    • While the incidence of breast cancer in young women has been increasing over the last 20 years, breast cancer deaths in this age group fell significantly between 2010 and 2020, researchers found.
    • Among women ages 20 to 49, incidence-based mortality declined from 9.70 per 100,000 women in 2010 to 1.47 per 100,000 in 2020, reported Adetunji Toriola, MD, PhD, MPH, of the Siteman Cancer Center at the Washington University School of Medicine in St. Louis, at the American Association for Cancer Research annual meeting in Chicago.” * * *
    • “While breast cancer mortality declined for each racial/ethnic group, rates differed substantially between groups.
    • “Black women had the highest incidence-based mortality in 2010 (16.56 per 100,000), and while that rate declined significantly over the next decade, these women still had the highest incidence-based mortality rate in 2020 (3.41 per 100,000).
    • “White women had the lowest incidence-based mortality in 2010 (9.18 per 100,000) and 2020 (1.16 per 100,000).
    • “Moreover, 5-year relative survival rates by race/ethnic group showed that rates exceeded 88.7% for most groups, except for Black women (82.4%). That discrepancy was similar for 10-year relative survival rates.
    • “There were significant declines in mortality among women aged 20 to 49 with breast cancer,” Toriola said during a press briefing. “However, there are still opportunities for improvements, especially in relation to eliminating disparities in survival.”
  • HCPLive informs us,
    • The burden of chronic kidney disease (CKD) attributable to physical inactivity increased significantly from 1990-2021, according to findings from a recent study
    • Leveraging data from the Global Burden of Disease (GBD) 2021, the study found that despite some regional declines in mortality rates, global CKD-related deaths and disability-adjusted life years (DALYs) have risen significantly, especially in low-sociodemographic index (SDI) regions, among older adults, and in females.1
    • “In recent years, low physical activity has become a major risk factor for noncommunicable diseases, contributing to the increased incidence of various chronic conditions, including diabetes, cardiovascular diseases, and CKD,” ZhenYi Zhao, of the School of Competitive Sports at Beijing Sport University in China, and colleagues wrote.
  • Per an NIH news release,
    • “The genes of male and female placentas have marked differences in how they are expressed, according to a study by researchers at the National Institutes of Health (NIH) and other institutions. These differences involve the presence or absence of tags on DNA known as methyl groups, which switch genes on or off without changing their structure. Understanding these DNA methylation patterns may inform future research on the higher risk for pregnancy complications involving male fetuses, such as stillbirth and prematurity, as well as later life health conditions that occur in adults who were born after a complicated pregnancy.”
  • The New York Times reports,
    • The happiness curve is collapsing.
    • For decades, research showed that the way people experienced happiness across their lifetimes looked like a U-shaped curve. Happiness tended to be high when they were young, then dipped in midlife, only to rise again as they grew old.
    • But recent surveys suggest that young adults aren’t as happy as they used to be, and that U-shaped curve is starting to flatten.
    • This pattern has shown up yet again in a new study, one of a collection of papers published on Wednesday in the journal Nature Mental Health. They are the first publications based on the inaugural wave of data from the Global Flourishing Study, a collaboration between researchers at Harvard and Baylor University.” * * *
    • “The study participants had relatively low measures of flourishing on average until age 50, the study found. This was the case in a number of countries, including the United Kingdom, Brazil and Australia. But the difference between the younger and older adults was largest in the United States, the researchers said.
    • “It is a pretty stark picture,” said Tyler J. VanderWeele, the lead author of the study and director of Harvard’s Human Flourishing Program. The findings raise an important question, he said: “Are we sufficiently investing in the well-being of youth?”
  • Healio relates,
    • “Individuals using e-cigarettes exclusively had a significantly elevated risk for COPD, whereas this was not found when assessing the risk for type 2 diabetes or heart failure, according to data published in Nicotine and Tobacco Research.
    • “For clinicians, these results offer helpful information about how e-cigarettes compare to regular cigarettes in terms of health risks,” John Erhabor, MD, MPH,research postdoctoral fellow at Johns Hopkins Medicine, told Healio. “While e-cigarettes may have fewer heart and metabolic risks than regular cigarettes, they are still tied to certain problems like COPD and possibly high blood pressure in some age groups.
    • “Doctors should take these differences into account when advising patients and make clear that switching completely from regular cigarettes to e-cigarettes may potentially lower health risks, but using both does not offer the same benefit,” Erhabor said.”
  • The American Medical Association News points out,
    • “The Health Resources and Services Administration announced its toll-free number (1-833-TLC-MAMA) and promotional toolkit are available in advance of Maternal Mental Health Awareness Week, May 5-11. Since its launch on Mother’s Day 2022, the hotline has received more than 54,173 calls and texts from individuals seeking help for themselves (73%) or on behalf of someone else (4%). The hotline is available in English and Spanish and offers interpreters in more than 60 languages.”
  • The U.S. Preventive Services Task Force released a final research plan for “Sexually Transmitted Infections: Behavioral Counseling.” The next step is a proposed recommendation.
  • STAT New warns,
    • The era of “tranq” may be ending.
    • “But tranq, as the powerful veterinary tranquilizer xylazine is known in the illicit drug supply, is being replaced at least in part by a dangerous new sedative: medetomidine. In the past year, the anesthetic has become an increasingly common element in the drug supply, with cities and states including Philadelphia, Pittsburgh, Chicago, and San Francisco reporting cases of medetomidine-involved overdoses.
    • “In Philadelphia in particular, reports of medetomidine have skyrocketed. When the city first began testing for the substance in May 2024, it found medetomidine in 29% of fentanyl samples analyzed, according to data from the city’s public health department. Six months later, medetomidine’s prevalence had increased threefold to 87% — while xylazine’s dropped from 100% early in the year to 42% in November.”
  • The CDC adds in a related report issued today,
    • Summary
    • What is already known about this topic?
      • Medetomidine is an increasingly common adulterant of illegally manufactured opioids.
    • What is added by this report?
      • During October 2024–March 2025, a total of 23 adult patients who used illegally manufactured opioids sought treatment within a health care system in Pittsburgh, Pennsylvania. All exhibited severe autonomic hyperactivity, and most required dexmedetomidine infusion and intensive care unit–level management. Medetomidine metabolites were detected in all 10 patients for whom retrospective analysis was performed, despite only two having detectable parent compound (medetomidine) on comprehensive urine drug screening.
    • What are the implications for public health practice?
      • Health care providers in regions where medetomidine has been detected in the drug supply should be prepared to manage a severe withdrawal syndrome among patients who use illegally manufactured opioids, even if drug testing for medetomidine is negative.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health’s insurance division Aetna will stop offering plans for individuals on the Affordable Care Act exchanges in 2026, after the company projected big losses in the business this year.
    • “The news was announced in tandem with CVS’ first quarter results, which exceeded investor expectations and represent a turnaround for CVS’ beleaguered insurance business, analysts said. The Rhode Island-based healthcare company reported net profit of $1.8 billion — up 60% year over year — on revenue of $94.6 billion.
    • “CVS’ pharmacy benefit manager Caremark also reached an agreement with Danish drugmaker Novo Nordisk to give its weight loss drug Wegovy preferred access on Caremark’s standard formulary, which covers tens of millions of Americans. The deal should increase access to Wegovy at the expense of other therapies, such as Eli Lilly’s Zepbound.”
  • Fierce Pharma notes,
    • “Moderna is extending its cost savings program into 2027 and targeting a cash breakeven point sometime in 2028 as the larger U.S. vaccine market faces new uncertainties under the Trump administration.
    • “Moderna aims to reduce its GAAP operating costs by 1.4 billion to $1.7 billion between 2025 and 2027, the company announced Wednesday. The Massachusetts biotech now targets $4.7 billion to $5 billion in GAAP costs in 2027, versus $7.2 billion last year.
    • “On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its cash operating costs from about $6.3 billion in 2024 to about $5.5 billion this year, and then further to $4.7 billion and $4.2 billion in the two subsequent years.
    • “Compared with cash operating costs, GAAP costs also include stock-based compensation for executives and asset value depreciation.”
  • The Leapfrog Group released its Spring 2025 hospital patient safety grades today.
  • Per MedTech Dive,
    • “GE Healthcare cut its 2025 adjusted earnings outlook to reflect an estimated 85-cent-per-share impact from tariffs, especially duties affecting trade with China, executives said on an earnings call Wednesday.
    • “CEO Peter Arduini said bilateral U.S. and China tariffs account for 75% of the total net impact.
    • “For the full year, GE Healthcare now expects adjusted earnings in a range of $3.90 to $4.10 per share, down from the prior estimate of $4.61 to $4.75.
    • “The revised outlook assumes that tariffs remain at the current elevated levels and that U.S. reciprocal tariffs on the rest of the world — announced April 2 — return to pre-pause rates on July 9. The forecast also assumes Mexico and Canada tariffs remain in place, with exemptions under the U.S.-Mexico-Canada Agreement continuing for all eligible imports.”
  • and
    • “Abbott has struck a deal to integrate data from its Libre continuous glucose monitors into Epic’s electronic health record systems in the U.S., the companies said Tuesday.
    • “The integration will connect Abbott’s data management software to Epic’s EHR systems. Linking the systems will allow clinicians to view glucose data captured by Libre devices within Epic. 
    • “The Epic integration could be the start of a broader Abbott initiative. Lisa Earnhardt, group president of medical devices for Abbott, said in a statement that the company aims to expand the integrated model to “other medical devices and connected care platforms in the future.”
  • Modern Healthcare reports,
    • “Medical weighing and measuring technology company seca launched the first compact, portable body composition scanner designed for primary care on Thursday.
    • “The mBCA Alpha scanner generates a detailed assessment of a patient’s body composition in 24 seconds, which includes percentages of fat, bone and muscle. Clinicians can use the information to spot early signs of excess body fat, age-related muscle decline and the impact medications like GLP-1s can have on the body, among other factors.
    • “Primary care physicians typically rely on weight and body mass indexing to determine a patient’s risk of chronic conditions such as obesity, diabetes, heart disease and metabolic syndrome. But body mass index doesn’t reflect muscle mass or fat distribution, which can vary significantly depending on age, gender and race, according to Nina Crowley, director of clinical education and partnerships at seca.
    • “The American Medical Association issued a policy update in June 2023 that called out body mass index as an imperfect way of measuring body fat in some populations and recommended it be used in conjunction with other screenings including body composition.
    • “Other imaging modalities like MRI and dual-energy X-ray absorptiometry can also provide information about a patient’s body composition, but Alpha can do it at a fraction of the cost, according to Crowley.”

Midweek Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC

  • Per a House Oversight Committee press release,
    • “As part of the budget reconciliation process, the House Committee on Oversight and Government Reform held a markup today and passed budget legislation that advances President Trump’s agenda and saves American taxpayers over $50 billion. The Committee will now finalize its section of the budget legislation and transmit it directly to the House Committee on the Budget, which will compile and present the final package for consideration by the U.S. House of Representatives.”
  • Govexec provides details on the markup here.
  • Federal News Network tells us,
    • “Agencies are facing a roughly two-week deadline to show the Trump administration how they plan to implement coming changes for probationary employees.
    • “By May 16, agencies are expected to report their plans for adding a new “affirmative” certification requirement for probationary employees. Agencies are also expected to detail how they intend to train supervisors and HR practitioners on the coming changes, according to new guidance the Office of Personnel Management published Tuesday.
    • “The guidance outlines more detailed expectations for agencies to update how they manage probationary periods following President Donald Trump’s executive order last Thursday. That order called for the creation of “Civil Service Rule XI” and added a hurdle for probationary employees to clear before they become tenured employees. Agencies will now be required to review and actively sign off on probationary workers’ continued employment before they can reach a tenured employment status.”
  • Per Healthcare Dive,
    • “House Republicans are calling on the Center for Medicare and Medicaid Innovation to rethink its priorities under the Trump administration, including by improving transparency with providers and focusing on payment models that save the government money.
    • “In a letter sent this week by Republicans on the House Ways and Means Committee to CMS Administrator Dr. Mehmet Oz and CMMI Director Abe Sutton, lawmakers said they were “concerned” with the innovation center’s track record of creating models that often don’t improve care quality or reduce costs. 
    • “The legislators added that CMMI has also “promoted a political agenda ahead of its Congressionally mandated purpose,” like focusing on health equity instead of cost savings.” 

From the Food and Drug Administration front,

  • STAT News points out,
    • “Nearly 12% of Americans still smoke cigarettes, the leading cause of preventable death nationwide. Yet there are only two medications authorized by the Food and Drug Administration to help them quit — the more effective of which, varenicline, can come with unsavory side effects like nausea that make people less likely to stick with treatment.
    • “A new pill with fewer side effects could soon be available from the Washington state-based biotech Achieve Life Sciences. The company plans to file for FDA approval of its drug, called cytisinicline, in June. 
    • “Rick Stewart, Achieve’s co-founder and CEO, told STAT that he expects the drug to be approved in mid-2026 and to launch in the U.S. by the end of that year. “This will be the first new drug for nicotine dependence in nearly 20 years,” he said.” 
  • Fierce Healthcare informs us,
    • “While Johnson & Johnson isn’t the first to secure FDA approval for an FcRn-blocking antibody in myasthenia gravis, the New Jersey drugmaker is confident that a broad label will land its product an enviable market position in the long run.
    • “The FDA on Wednesday approved J&J’s nipocalimab under the brand name Imaavy as a new treatment option for generalized myasthenia gravis (gMG). The green light, which J&J says covers the “broadest population of people living with gMG,” includes patients ages 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
    • “Anti-AChR and anti-MuSK antibody-positive people make up more than 90% of the total antibody-positive gMG population, J&J estimates. All told, the company figures gMG—which causes the communication between the body’s nerves and muscles to break down—affects around 700,000 people worldwide.”
  • Per MedTech Dive,
    • “Medtronic has won Food and Drug Administration approval for the Omniasecure defibrillation lead, the company said Friday.
    • “The lead connects to an implantable defibrillator and treats potentially life-threatening types of irregular heart rhythm. Medtronic said Omniasecure is the world’s smallest defibrillation lead.
    • “The approval limits the use of the lead to the right ventricle. Medtronic shared data on placing the lead in the left bundle branch last week but has yet to win FDA approval in that setting.
  • MedCity News lets us know,
    • “Patients with the most severe form of a certain inherited disease have skin that is susceptible to wounds, some that never fully heal. For years, the only treatment was supportive care, including laborious and frequent changes of wound dressings covering much of the body. Biotechnology research in this disease, epidermolysis bullosa (EB), has pursued therapeutic options. A personalized treatment that Abeona Therapeutics makes from a patient’s own skin cells is now approved by the FDA, marking the agency’s third approval in this rare disorder in the past two years.
    • “The regulatory decision announced Tuesday covers the treatment of wounds in adults and children who have recessive dystrophic epidermolysis bullosa (RDEB). The therapy, known in development as prademagene zamikeracel, or pz-cel for short, will be marketed under the brand name Zevaskyn. Cleveland-based Abeona expects Zevaskyn will become available in the third quarter of this year.
    • “We have heard from the RDEB community that there is a persistent, unmet need to meaningfully heal RDEB wounds, especially those that are chronic and prone to infection,” CEO Vishwas Seshdari said during a Tuesday morning conference call. “Through a single application, Zevaskyn can provide people with RDEB the opportunity for significant wound closure and pain reduction in even the most severe wounds.”

From the judicial front,

  • Federal News Network relates,
    • “The U.S. Supreme Court said Wednesday that federal employees who also are in the military reserve must be paid the equivalent of their civilian salaries when called to active duty during national emergencies.
    • “The 5-4 decision could affect hundreds of thousands of people, ensuring that they don’t suffer financially when they temporarily leave one form of government service for another.
    • “The justices ruled in an appeal filed by an air traffic controller who spent about five years on active duty in the Coast Guard at a pay rate lower than what he earns as a Federal Aviation Administration employee.”
  • Reuters reports,
    • “Genetic testing company 23andMe agreed on Tuesday to allow a court-appointed overseer to take charge of ensuring customers’ genetic data remains protected during the company’s bankruptcy, settling a dispute with several U.S. states.
    • “Those states had argued the company was not taking data security seriously enough.
    • “U.S. Bankruptcy Judge Brian Walsh approved the agreement at a court hearing in St. Louis, Missouri, ordering the appointment of a consumer protection ombudsman who will be empowered to review 23andMe’s handling of customers’ genetic information and its security policies.”

From the public health and medical research front,

  • CNBC reports,
    • “Aon researchers found that within two years, improved health outcomes for patients who were taking GLP-1 drugs lowers the growth rate of medical care costs. 
    • “Aon looked at medical claims data for 139,000 U.S.-based workers with employer health coverage who took GLP-1 medications between 2022 and 2024.
    • “Since 2023, GLP-1s have driven up employer spending on drugs at a faster pace than high-priced specialty drugs used to treat cancer and autoimmune conditions, according to an Evernorth study.”
  • Beckers Hospital Review considers what is driving increased use of GLP-1 drugs among children.
  • Per Cardiovascular Business,
    • “Drinking champagne may be associated with significant cardiovascular benefits, according to a new study published in the Canadian Journal of Cardiology.
    • “The study identified dozens of lifestyle changes that may help lower a person’s risk of sudden cardiac arrest (SCA). Some of the changes—eating more fruit, losing weight—were straightforward, but a few of the research team’s findings were unexpected. Drinking champagne and/or white wine, for example, was linked to a reduced SCA risk. The same was also true for spending more time at a computer—though that may tell us more about education levels than screen time.
    • “These findings all come from a new exposome-wide association study (EWAS) out of China. The study’s authors explored the UK Biobank study, focusing on data from more than 500,000 patients. They then looked for associations between SCA and 125 different modifiable lifestyle factors.
    • “To our knowledge, all previous studies on the risk factors of SCA were hypothesis-driven and focused on a limited number of candidate exposure factors grounded in previous knowledge or theoretical frameworks,” wrote first author Huihuan Luo, PhD, a researcher with Fudan University in Shanghai, China, and colleagues. “This might lead to publication bias distorting summary conclusions and might increase the likelihood of false positive findings resulting from inter-related exposures. More importantly, the hypothesis-driven approach might miss important exposures or relationships beyond the predefined hypothesis. To tackle these limitations, a hypothesis-free, data-driven EWAS has emerged as a robust analytical framework for simultaneously exploring hundreds of exposures. This data-driven approach does not rely on previous knowledge and facilitates the identification of novel or underexplored associations.” * * *
    • Click here for the full study.
  • Per Medscape,
    • “People with osteoarthritis are more likely to be diagnosed with other pain-related comorbidities such as fibromyalgia, chronic fatigue syndrome (CFS), gout, and irritable bowel syndrome and psychological comorbidities such as depression, according to observational data presented at the World Congress on Osteoarthritis (OARSI) 2025 Annual Meeting.
    • “The study also found that all these five conditions were themselves associated with an increased risk for incident osteoarthritis, and in the case of fibromyalgia, there may be a causal association.
    • “Physiotherapist and epidemiologist Subhashisa Swain, MPH, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, Oxford, England, presented an analysis of data from the multicenter European Comorbidities in Osteoarthritis (ComOA) study, which is examining electronic health records to identify associations between 61 different comorbidities with osteoarthritis and the clusters and trajectories of those comorbidities and osteoarthritis.”
  • The New York Times offers guidance on hip exercises.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana beat earnings expectations for the first quarter and reaffirmed its 2025 guidance on Wednesday, after medical costs came in as predicted. It’s a positive development for the insurer, which has been rocked by higher spending in privatized Medicare plans and the safety-net Medicaid program.
    • “Humana attributed the results to higher Medicare and Medicaid premiums and membership growth in Medicare prescription drug plans and state contracts. Earnings were offset somewhat by an ongoing decline in Medicare Advantage membership after Humana culled underperforming plans to resuscitate margins this year.
    • “However, it’s still early in 2025, so Humana is remaining cautious when it comes to medical utilization, executives said. The payer’s outlook is also complicated by uncertainty stemming from its ongoing legal bid to improve MA quality ratings.”
  • The American Hospital Association News notes,
    • “The AHA April 30 released a report highlighting how hospitals and health systems continue to experience significant financial headwinds that can challenge their ability to provide care to their patients and communities. The report outlines the financial burden of heightened expenses hospitals have faced in recent years in caring for patients, as well as the increasing strain on the field.  
    • “It explains how hospitals have raised wages to recruit and retain staff amid workforce shortages and how Medicare and Medicaid continue to underpay hospitals for patient care as shortfalls worsen. Other findings include how practices of certain Medicare Advantage plans exacerbate hospitals’ financial burden, and that tariffs on medical imports could significantly raise costs for hospitals as nearly 70% of medical devices marketed in the U.S. are manufactured exclusively overseas. 
    • “This report should serve as an alarm bell that a perfect storm of rising costs, inadequate reimbursement, and certain corporate insurer practices are jeopardizing the ability of hospitals to deliver high-quality, timely care to their communities,” said AHA President and CEO Rick Pollack. “With so much at stake, policymakers must recommit to making preserving access to hospital care a national priority.” 
  • The Wall Street Journal reports,
    • “Trump’s executive order on drug prices is seen as a win for the pharmaceutical industry.
    • “Drugmakers spent millions lobbying against pharmacy-benefit managers (PBMs), blaming them for high drug prices.
    • “PhRMA funded various groups, including minority healthcare nonprofits, to criticize PBMs.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group announced Tuesday that Patrick Conway, M.D., would take the helm of its Optum division.
    • “Conway, an insurance industry and health policy veteran, was previously the CEO of Optum’s pharmacy benefit management unit, Optum Rx. He also held leadership roles at the company’s healthcare delivery arm, Optum Health.
    • “Conway will step in as CEO of Optum on May 6. His prior work includes serving as the director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services, which is responsible for developing critical payment models for government insurance programs.”
  • and
    • “Despite the poor financial performance of BetterHelp, whose revenue fell by 11% in Q1, Teladoc has grown its investment in virtual mental healthcare by acquiring UpLift in a $30 million all-cash transaction.
    • “The deal closed on April 30, the same day as Teladoc’s first quarter 2025 earnings call. The company fared worse than Wall Street expected in Q1, posting a net loss of $93 million, or $0.53 lost per share. Wall Street Analysts expected the company share price to decrease by $0.33.
    • “A significant upside to the acquisition is the new-found ability for BetterHelp customers to use insurance coverage for mental health services, a barrier that has kept some customers from signing up with the cash-pay mental health provider. UpLift will be included in the company’s BetterHelp reporting segment going forward, executives said.
    • “UpLift provides virtual mental health therapy, psychiatry and medication management services. It serves the health plan market and covers 100 million lives. It has a network of over 1,500 mental health providers.”
  • Per BioPharma Dive,
    • “Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades ago with plans to make drugs capable of targeting small strips of nucleic acid known as microRNA.
    • “Announced Wednesday, the acquisition will hand the Swiss pharmaceutical firm a drug prospect called farabursen, which recently completed a Phase 1b study in people with autosomal dominant polycystic kidney disease, or ADPKD.
    • “Per deal terms, Regulus shareholders will receive $7 in cash per share, a premium of more than 100% to the stock’s closing price Tuesday. Additionally, Novartis has committed to pay an additional $7 per share via a so-called contingent value right that’s linked to the achievement of an unspecified regulatory milestone.”
  • and
    • “Sales of BridgeBio’s new heart medicine Attruby blew past analyst expectations in the first quarter, as the company built by “science nerds” took on market behemoth Pfizer.
    • “Net product revenue reached $36.7 million in the period, surpassing the consensus analyst estimate of $12.6 million. The drug won Food and Drug Administration approval in November to treat a genetic condition known as transthyretin amyloidosis with cardiomyopathy.
    • “As of April 25, Attruby had 2,072 prescriptions written by 756 prescribers, BridgeBio said Tuesday after the market closed. That momentum built on encouraging numbers released in February and helped push the company’s shares up in early trading Wednesday.”
  • Per Beckers Hospital Review,
    • “Mark Cuban Cost Plus Drug Co. has secured another partnership targeting the specialty pharmaceutical market, according to an April 28 news release shared with Becker’s. 
    • “EverPharm, a specialty unit-dose medication company, is joining its portfolio with Cost Plus Drugs’ pricing model, which is the drug’s manufacturing cost plus a 15% markup and a $10 shipping and labor fee. On April 16, Cost Plus Drugs launched a similar partnership with Morris & Dickson, a full-line and specialty pharmaceutical distributor. 
    • “The partnership with EverPharm will roll out in phases, the release said, with an initial focus on offering key unit-dose medicines to pharmacies and healthcare providers through the Cost Plus Marketplace.” 

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.”