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.