FEHBlog

Midweek Update

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, SCOTUS, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • It turns out that at yesterday’s markup meeting, the House Oversight and Government Reform Committee did clear HR 2193, the FEHB Protection Act of 2025, for floor consideration, along with the other bills considered during the markup.
  • The Senate confirmed James Bishop to be Deputy Director of the Office of Management and Budget by a 53-43 vote.
  • CMS today released a “Revised Final 2026 Actuarial Value (AV) Calculator Methodology.”
    • “The only changes that are being made to the Final 2026 AV Calculator as part of this Revised Final 2026 AV Calculator are the following:
      • “The de minimis range for bronze, silver, gold and platinum plans was expanded to +2
      • percentage points to -4 percentage points;
      • “The de minimis range for expanded bronze plans was expanded to +5 percentage points
      • to -4 percentage points;
      • “The de minimis range for income-based silver CSR plans was expanded to +1 percentage
      • points to -1 percentage points;
      • “The MOOP limit was updated to $10,600; and
      • “The AV Calculator version number was updated, and the AV Calculator label was
      • updated to “Revised Final 2026 AV Calculator”.
    • “These changes do not affect the AV calculation methodology. All AV calculations are the same
    • in both the Final 2026 AV Calculator and the Revised Final 2026 AV Calculator.”
  • The Congressional Research Service has summarized the federal requirements on private health insurance plans.
  • Per the American Hospital Association (“AHA”) News,
    • “The FBI March 26 advised that, after extensive investigation and intelligence review, they have not identified any specific credible threat targeted against hospitals in any U.S. city. The FBI advised if they receive credible threat information, they will immediately advise any identified potential targets and, if appropriate, alert the broader health care sector through the AHA, the Health-ISAC (Information Sharing and Analysis Center) and other appropriate channels. 
    • “On March 18, the AHA and Health-ISAC received multiple reports from the field regarding a public social media post alleging active planning of a coordinated, multi-city terrorist attack targeting hospitals in the coming weeks. 
    • “Out of an abundance of caution, the AHA and Health-ISAC notified the field of the potential threat, indicating that no further information was available to either corroborate the threat or dismiss it as not credible. The AHA and Health-ISAC today distributed an updated bulletin to members with the latest update from the FBI.” 

From the judicial front,

  • Bloomberg Law informs us,
    • “The US Supreme Court suggested [during an oral argument today] it’s likely to uphold a federal program that uses more than $8 billion in fees imposed on phone bills to subsidize the cost of telecom services for poor people, rural residents, schools and libraries.
    • “Hearing arguments in Washington on the decades-old Universal Service Fund, some conservative justices voiced concern that Congress had unconstitutionally handed off its taxing power to the Federal Communications Commission without imposing sufficient limits.”

In Food and Drug Administration news,

  • BioPharma Dive relates,
    • “The Food and Drug Administration on Wednesday approved the first treatment for the insatiable hunger associated with the rare disease Prader-Willi syndrome, a long-awaited decision that follows an unorthodox pitch from the drug’s developer.
    • “The agency on cleared Vykat XR, from biotechnology company Soleno Therapeutics, for this hyperphagia that’s caused by Prader-Willi. Treatment has specifically been approved for adults and children at least four years of age. Soleno hasn’t yet disclosed the drug’s list price. 
    • “The approval is a milestone for research into a disease that’s proven difficult to target. Prader-Willi affects an estimated 10,000 to 20,000 people in the U.S. and causes multiple cognitive and behavioral symptoms.”
  • Per a National Cancer Institute (NCI) news release,
    • “The Food and Drug Administration (FDA) has given an accelerated approval to zenocutuzumab (Bizengri), making it the first drug that targets tumors with a very rare genetic alteration called an NRG1 fusion. Under the approval, zenocutuzumab can be used to treat people with pancreatic or non-small cell lung cancer (NSCLC) whose tumors have an NRG1 fusion and whose disease has gotten worse despite standard treatments.
    • “The approval was based on the results of a clinical trial in which one-third of patients treated with zenocutuzumab had sustained tumor shrinkage of at least 30% that lasted a median of 11 months. Most of the patients in the study had either NSCLC or pancreatic cancer.
    • “This is a patient population that has a very high unmet need,” said the study’s lead investigator, Alison Schram, M.D., of the Memorial Sloan Kettering Cancer Center. “This approval gives these patients, who have very few effective therapeutic options, a new treatment option.”
    • “Because it’s an accelerated approval, Partner Therapeutics, which licensed zenocutuzumab from Merus, must conduct additional studies to confirm that the drug helps patients clinically, which can include helping them live longer than with other treatments.’

From the public health and medical research front,

  • The New York Times reports,
    • Measles cases in Kansas more than doubled in the last week, bringing the tally to 20, while another outbreak in Ohio has sickened 10 people, local public health officials reported on Wednesday.
    • There have been several large outbreaks in the United States this year, including one in West Texas that has spread to more than 320 people and hospitalized 40. Health officials have worried that the Texas outbreak may be seeding others.
    • More than 40 measles cases have been reported in New Mexico, and seven have been identified in Oklahoma. In both states, health officials said the infections were connected to the Texas outbreak.
    • In Kansas, the virus has mainly infected unvaccinated children in the southwest corner of the state. Genetic sequencing has suggested a link to the Texas and New Mexico outbreaks, state health officials told The New York Times on Wednesday.
  • Per the AHA News,
    • “A study published March 26 by the National Institutes of Health and the University of Oxford found that individuals who engaged in light and moderate-to-vigorous daily physical activity had a lower cancer risk than those with more a sedentary lifestyle. The study found that higher daily step counts, but not pace, was also associated with a lower cancer risk. In comparison to cancer risk for individuals taking 5,000 steps per day, risk was 11% lower for those taking 7,000 steps per day and 16% lower for those taking 9,000 steps per day. Risk reduction plateaued beyond 9,000 steps.”
  • This week’s Cancer Information Highlights from the NCI discuss “Quit Smoking | Metastatic Prostate Cancer | Kidney Cancer.”
  • The National Institute of Standards and Technology informs us,
    • “A rare but painful disorder can make it difficult for people to swallow food. The symptoms include weight loss and chest pain after eating. Scientists are working to better understand this condition, known as corkscrew esophagus, in hopes of finding more treatment or prevention options.
    • “We are working to contribute to that effort with an approach you may not associate with medical research. It involves math, physics and computer modeling.”
  • Medscape points out,
    • “In a recent final analysis of a phase 3 trial, the bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine [which are FDA approved] maintained high efficacy and a favorable safety profile against RSV-associated lower respiratory tract illness (RSV-LRTI) over two seasons in people aged ≥ 60 years.”
  • STAT News tells us, “Study suggests mRNA vaccine could make humans resistant to ticks that transmit Lyme bacteria. New tool shows how the human immune system responds to components of ‘tick cement.’”
    • “Ticks, once latched onto a fleshy target with their barbed, needle-like mouths, are ready for almost anything. They glue themselves to the skin using a complex, cement-like substance. And then, like a “little pharmacological company,” they dole out proteins to keep the blood flowing, make it relatively painless, and hamper any immune response that might reveal their parasitic presence, Yale University researcher Erol Fikrig says.
    • “It’s in those days of quiet blood-thirst that ticks pass along bacteria that causes conditions like Lyme disease, a growing problem driven in the U.S. by black-legged ticks (or Ixodes scapularis). Researchers have been trying for decades to understand just how the tiny tick is able to evade the human body’s defenses and pass along pathogens. 
    • “A new study by Fikrig and other researchers, published Wednesday in Science Translational Medicine, uses a powerful monitoring system to reveal how the human immune system is responsive to a litany of tick triggers — some of which might be leveraged to create a protective mRNA vaccine.” 
  • Per Fierce Pharma,
    • “Johnson & Johnson has produced the most convincing data to date that its combination of Rybrevant and Lazcluze could replace AstraZeneca’s Tagrisso as the new standard of care in first-line EGFR-mutated non-small cell lung cancer—proof it could extend patients’ lives.
    • “The Rybrevant-Lazcluze combo significantly reduced the risk of death by 25% versus Tagrisso in patients with newly diagnosed advanced EGFR-mutated NSCLC, according to data from the phase 3 Mariposa trial presented at the European Lung Cancer Congress (ELCC) 2025.
    • “While the median overall survival time was not yet reached for the combo, investigators expect that the J&J regimen could offer at least an extra year of life versus Tagrisso, on which patients have logged a median 36.7 months of survival.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Fewer physicians are considering leaving the profession in 2025 than in 2024, according to a new survey from the Harris Poll and electronic health record provider Athenahealth.
    • “Part of physicians’ improved job satisfaction was driven by increased adoption of artificial intelligence, the researchers said. Fewer physicians reported the technology was over-hyped this year, and they saw the most promise in transcription services and capabilities.
    • “Still, physicians shared concerns about the fate of the industry long-term and only 3 in 10 physicians were optimistic about the direction of U.S. healthcare generally. Respondents were most concerned about interoperability challenges, their organization’s financial health and meeting regulatory requirements.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec (Nanoscope Therapeutics) for the treatment of advanced retinitis pigmentosa.”
      • Key Clinical Findings
        • “For adults with advanced retinitis pigementosa and severe vision loss, ICER rated the current evidence on sonpiretigene isteparvovec as promising but inconclusive (“P/I”) due to concerns about durability of benefits and unknown short-term and long-term harms.
      • Key Cost-Effectiveness Findings
        • “Sonpiretigene isteparvovec has not yet been approved by the FDA for retinitis pigmentosa, and the manufacturers have not yet announced a US price for the therapy if approved. 
        • “ICER has calculated a health benefit price benchmark (HBPB) to be between $67,400 and $101,300 for treatment in one eye.”
  • The Brown & Brown consulting firm has posted an executive summary of its 2025 Employee Health and Benefits Strategy Survey.
  • Beckers Health IT survey notes,
    • “Amazon is testing a generative AI-powered health assistant, dubbed Health AI, on its website and mobile app, CNBC reported March 25.
    • “The chatbot is designed to answer health and wellness questions, suggest common care options for various medical needs, and recommend products. Some responses are marked with a “clinically verified” badge, indicating that the information has been reviewed by U.S.-based licensed clinicians, according to Amazon.
    • “In addition to providing health guidance, Health AI directs users to Amazon’s online pharmacy and clinical services from One Medical, the primary care provider Amazon acquired for $3.9 billion in 2022.”

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, NIH, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Bloomberg Law tells us,
    • “The Senate voted to confirm Jay Bhattacharya, a Stanford University health economist and physician, to lead the National Institutes of Health. 
    • “Senators confirmed him Tuesday evening 53-47 on a party line vote.” 
    • “The Senate also confirmed Marty Makary, a surgeon at Johns Hopkins Medicine, to oversee the Food and Drug Administration. Unlike many of President Donald Trump’s nominees for health positions, a few Democrats chose to support Makary as well. The Senate confirmed him by a 56-44 vote.
  • The American Hospital News informs us,
    • “The Senate Finance Committee March 25 advanced Mehmet Oz’s nomination for administrator of the Centers for Medicare & Medicaid Services by a vote of 14-13. Oz, a doctor and former television show host, will soon be considered by the full Senate for confirmation.” 
  • Govexec relates,
    • “[The] House Oversight and Government Reform Committee on Tuesday debated legislation that would set up a process for Congress to approve President Donald Trump’s overhauls of federal agencies. 
    • “The Reorganizing Government Act of 2025 (HR 1295), which is scheduled to receive a panel vote at 6:30 p.m., would resurrect a lapsed authority enabling the president to submit a plan for restructuring agencies that Congress must vote on within 90 days. Such a plan is not subject to the filibuster, meaning the Senate can clear it with a simple majority instead of the usual 60-vote threshold. 
    • “Still, the bill itself would need 60 votes for the Senate to pass it, which is unlikely.” 
  • At this markup session, the Oversight and Reform Committee was poised to approve HR 2193, the FEHB Protection Act of 2025 in a bipartisan fashion, but due to the length of the markup session, the Chairman postponed roll call votes until a later date. HR 2193 would tighten oversight over FEHB family member eligibility.
  • Federal News Network lets us know,
    • “Former Postmaster General Louis DeJoy avoided several third-rail issues, as part of his plans to modernize the Postal Service — including privatizing the agency, closing post offices or cutting the number of delivery days each week.
    • “Leaders of three USPS unions say they aren’t so sure DeJoy’s successor or the Trump administration will agree to the same red lines, as the White House envisions major changes for the independent mail agency.”

From the judicial front,

  • Roll Call points out,
    • “The Supreme Court is set to hear arguments in a pair of cases Wednesday over how much power Congress can give to executive agencies without running afoul of the Constitution, which could end up shaping how legislation is written.
    • “The arguments center on whether Congress handed over too much power to the Federal Communications Commission when it created the Universal Service Fund. The fund collects money from telecommunications companies and distributes funds intended for telecommunications services nationwide.
    • “Several experts said the cases come as a majority of the members of the conservative-controlled Supreme Court have expressed interest in imposing new limits on what’s called the “nondelegation doctrine” — or how much legislative power Congress can cede to other entities. Depending on how the justices handle the complicated case, experts said, it could have wide-ranging impacts on federal agencies.”

From the public health and medical research front,

  • Medscape delves into “Avian Influenza: What Infectious Disease Physicians Need to Know.”
  • FiercePharma reports,
    • “GSK is opening the door to a new era in urinary tract infection (UTI) treatment with its Blujepa, the first in a new class of oral antibiotics for the condition in nearly 30 years.
    • “Blujepa, also known as gepotidacin, has been cleared by the FDA to treat uncomplicated UTIs (uUTIs) that can be tied to E. coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus or Enterococcus faecalis in women 12 years of age and older. “These types of UTIs are the most common infection for women, with more than half of all women experiencing one in their lifetime, making the antibiotic a much-needed new option for the up to 16 million U.S. women who are impacted annually. 
    • “GSK tested the antibiotic in the phase 3 Eagle-2 and Eagle-3 trials, pitting its twice-daily option against longtime standard-of-care nitrofurantoin for five days.” 
  • JAMA Online considers
    • “Question   Which health conditions, types of care, and counties are associated with the highest levels of spending?
    • “Findings   This observational study showed considerable variation in spending across health conditions, types of care, age groups, payers, and counties—with spending being greatest for type 2 diabetes. Across counties, there was more variation in utilization rates rather than price and intensity of care.
    • “Meaning   Further investigation into unexplained variation in spending, focusing on the health conditions with the most spending, could help inform health care policies aimed at lowering costs and improving access to care.
  • The NIH Research Matters Bulletin discusses “Norovirus antibodies | Non-opioid pain relief | Tardigrades & cancer care.”
  • Per Cardiovascular Business,
    • “A new drug has shown early potential to slow the progression of aortic stenosis (AS) and potentially limit the number of heart patients who require transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). 
    • “The team behind this breakthrough, a group of healthcare researchers out of Mayo Clinic, shared its early progress in Circulation.
    • “The drug in question, ataciguat, is able to reactivate oxidized soluble guanylate cyclase, which then limits signals in the body that can lead to fibrocalcific aortic valve stenosis (FCAVS). After observing this phenomenon in action in animal models and in vitro, the Mayo Clinic researchers performed a phase I clinical trial that showed ataciguat is well tolerated in patients with FCAVS. The group then compared ataciguat with a placebo in a phase II clinical trial, finding that six months of treatment with the drug was associated with a significant reduction—nearly 70%—in the progression of aortic valve calcification in patients who presented with moderate FCAVS. Treatment with ataciguat also “tended to slow other changes in valvular and ventricular dysfunction, reflective of disease progression,” in these patients.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Demand for GLP-1 drugs is causing spending on traditional drugs to grow at a faster clip than spending on specialty drugs, according to new research. That could put further stress on employers and health plans struggling to contain already sky-high spending on prescription drugs.
    • “Spending growth for traditional drugs — simple-to-administer medications used to treat common health problems — outstripped spending growth for specialty drugs — pricey medications used to treat complex and chronic conditions — for the first time in 2023, according to a report released Tuesday by Evernorth, the health services division of national insurer Cigna.
    • “The trend isn’t expected to revert, at least in the next few years, amid sustained demand for GLP-1s for weight loss and as the drugs become approved for more conditions, Evernorth said.”
  • Fierce Pharma adds,
    • “Novo Nordisk has quickly expanded its discounted Wegovy program, now offering all eligible cash-paying customers its popular weight-loss med at $499 per month.
    • “Novo had only launched the cheaper Wegovy option earlier this month originally through its own NovoCare Pharmacy and at that time indicated an expansion to traditional retail channels “in the near future.”
    • “Now, less than three weeks later, all cash-paying patients can purchase any Wegovy injection doses—from 0.25mg to 2.4mg—at their local pharmacies for $499 for a 28-day supply, Novo said Monday. The new price tag marks a further cut from Novo’s previous policy that offered self-pay patients Wegovy at a cost of $650 per month.”
  • Per STAT News,
    • “The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — rose a modest 0.4% in last year’s fourth quarter, but that compared unfavorably with a 3% decline in the same period a year earlier, according to the latest data from SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends.
    • “A key reason was that net prices rose for so-called protected oncology medicines, one of six classes of drugs for which Medicare Part D generally covers an entire category. Typically, these six classes have smaller and more stable discounts compared with other medicines in the marketplace. As a result, net prices rose faster for protected classes, but it is not clear why this occurred more so with cancer drugs.
    • “Tugging in the other direction was a type of medicine known as disease-modifying antirheumatic drugs, such as Humira, which are used to treat rheumatoid arthritis and other maladies. Ongoing pricing pressure caused by a growing number of biosimilars — nearly identical variants of brand-name biologic medicines that yield the same health outcomes but at a lower cost — stifled further rises in net prices.
    • “Meanwhile, list prices for all drugs grew 1.4% in the first quarter of the year compared with 5.4% a year earlier. Most of the slower growth rate was traced to major insulin makers — Eli Lilly, Novo Nordisk, and Sanofi — that lowered prices for many patients with private insurance, but also to comply with the Inflation Reduction Act, which required capping monthly out-of-pocket costs at $35 for Medicare beneficiaries.”
  • The American Benefits Council has posted a detailed report titled “Destination 2030: A Road Map for the Future of Employer-Provided Benefits.” “This 2030 strategic plan describes the five most pressing challenges facing employer-sponsors today, provides four goals to address each challenge and then offers detailed policy recommendations for meeting those goals.”

Monday Report

David Ermer–CDC, CMS, Congress, HIPAA Privacy and Security Rules, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network reports,
    • “Postmaster General Louis DeJoy will leave the Postal Service’s top job by the end of the day Monday, after he announced plans to leave the agency last month.
    • “I have today informed the Postal Service Board of Governors that today will be my last day in this role,” DeJoy said in a statement.
    • “DeJoy announced last month he was preparing to step down as postmaster general and urged the USPS Board of Governors to begin the search for his successor.
    • “Deputy Postmaster General Doug Tulino will lead USPS until its Board of Governors selects a new postmaster general.”
  • The Wall Street Journal informs us,
    • “President Trump nominated the acting director of the Centers for Disease Control and Prevention to lead the agency permanently, after dropping his first pick for the job.  
    • “Susan Monarez was named acting director of the CDC early in the Trump administration and has worked closely with Health Secretary Robert F. Kennedy Jr.’s leadership team to fight a measles outbreak in Texas.
    • “Dr. Monarez will work closely with our GREAT Secretary of Health and Human Services, Robert Kennedy Jr. Together, they will prioritize Accountability, High Standards, and Disease Prevention to finally address the Chronic Disease Epidemic and, MAKE AMERICA HEALTHY AGAIN!” Trump wrote Monday on Truth Social.
    • “Monarez has a Ph.D. in microbiology and immunology from the University of Wisconsin-Madison and subsequently studied at Stanford University.
    • “She would be the first CDC director without a medical degree in more than 70 years. She must be confirmed by the Senate.”
  • The Wall Street Journal also seeks to explain how the Medicaid program works in charts.
  • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will mark up the nomination of Dr. Mehmet Oz to be Centers for Medicare and Medicaid Services (CMS) Administrator during an executive session on Tuesday, March 25, at 9:30 AM.” 

From the judicial front,

  • The Wall Street Journal lets us know,
    • “The Justice Department asked the Supreme Court on Monday to block a judge’s order requiring it to reinstate more than 16,000 federal employees, as administration officials vow to seek the justices’ intervention in clearing away lower-court rulings that have slowed Trump policies. 
    • “Earlier this month, a federal district judge in San Francisco ordered the government to reinstate probationary employees fired at a half dozen agencies under the Trump administration’s fast-moving plan to shrink the federal government. U.S. District Judge William Alsup found that the administration had failed to comply with legal procedures required for the layoffs. 
    • “Alsup’s order, and a similar one from a federal judge in Maryland, require agencies to offer the employees their jobs back while litigation over the legality of the layoffs proceeds. 
    • “In her Supreme Court brief, acting Solicitor General Sarah Harris argues that the case should have been thrown out of court because it was filed by labor unions and other organizations rather than the terminated employees themselves. Federal law requires government employees to raise complaints through an internal process before going to court, Harris said.” 
  • Bloomberg Law tells us,
    • “A group of former Wells Fargo employees failed to prove the bank neglected its fiduciary duties over its health plan’s prescription drug costs because they could not prove concrete harm, a federal judge in Minnesota ruled Monday.
    • “The workers sued in July in the US District Court for the District of Minnesota, alleging the plan paid excessive administrative fees and prescription drug prices compared to other large employer plans. Wells Fargo & Co. also violated the Employee Retirement Income Security Act by allowing pharmacy benefit manager Express Scripts to keep drug manufacturer rebates instead of passing them back to the plan, the employees argued.
    • “The high-profile case is part of a wave of legal challenges to rising employer health plan costs, with workers suing employers and employers suing their benefit administrators. The lawsuits follow legislative and regulatory changes strengthening transparency and fiduciary requirements for insurers and employers—scrutiny that is expected to continue from lawmakers and the Trump administration.
    • “The court agreed with the plaintiffs “in theory” that they could be injured by Wells Fargo’s PBM contract. But the former employees ultimately failed to prove standing because the plan covers a broad range of drugs beyond those cited in the complaint, and because the plan picks up costs after the plaintiffs hit their deductibles, the court concluded.
    • “There are simply too many variables in how Plan participants’ contribution rates are calculated to make the inferential leaps necessary to elevate Plaintiffs’ allegations from merely speculative to plausible,” Judge David T. Schultz wrote in his order dismissing the case.”
    • FEHBlog note — Judge Laura M. Provinzino wrote the decision, not Judge Schultz.

From the public health and medical research front,

  • The AP relates,
    •  “Tuberculosis continued to rise again in the U.S. last year, reaching its highest levels in more than a dozen years. 
    • “More than 10,300 cases were reported last year, an 8% increase from 2023 and the highest since 2011, according to preliminary data posted this month by the Centers for Disease Control and Prevention. 
    • “Both the number of cases and the rate of infections rose. Rates were up among all age groups, and 34 states reported an increase. 
    • “CDC officials say the rise is the mainly due to international travel and migration. The vast majority of U.S. TB cases are diagnosed in people born in other countries. Other illnesses that weaken the immune system and allow latent TB infections to emerge may also be at play.”
  • NBC News reports,
    • “Cervical cancer is one of the most preventable cancers, although recent research suggests that the United States is backsliding in efforts to detect the disease early, when it is most curable.
    • “A new study shows that the percentage of women screened for cervical cancer fell from 47% in 2019 to 41% in 2023.
    • “Rural women are 25% more likely to be diagnosed and 42% more likely to die from cervical cancer than women who live in cities, a trend that likely reflects lower screening rates in less populated areas, according to the study, published in JAMA Network Open this month.” 
  • Consumer Reports, writing in the Washington Post, explains “How to find a home health aide. Having the right person can make caring for a loved one much easier. Here are tips for finding and affording the help.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have developed eye drops that extend vision in animal models of a group of inherited diseases that lead to progressive vision loss in humans, known as retinitis pigmentosa. The eye drops contain a small fragment derived from a protein made by the body and found in the eye, known as pigment epithelium-derived factor (PEDF).  PEDF helps preserve cells in the eye’s retina. A report on the study is published in Communications Medicine.
    • “While not a cure, this study shows that PEDF-based eye drops can slow progression of a variety of degenerative retinal diseases in animals, including various types of retinitis pigmentosa and dry age-related macular degeneration (AMD),” said Patricia Becerra, Ph.D., chief of NIH’s Section on Protein Structure and Function at the National Eye Institute and senior author of the study. “Given these results, we’re excited to begin trials of these eye drops in people.”

From the healthcare business front,

  • The Wall Street Journal reports,
    • “Novo Nordisk agreed to pay up to $2 billion for the rights to a developmental weight-loss and obesity drug from Chinese pharmaceutical company the United Bio-Technology (Hengqin) Co., as it looks to boost its pipeline of next-generation drugs.
    • “Novo Nordisk, which earlier Monday lost its crown as Europe’s most valuable company, said it signed an exclusive global licensing deal for UBT251, a drug that targets three different hormones to treat obesity, type 2 diabetes, and other diseases.
    • “The Danish pharmaceutical company will pay $200 million up front and potential milestone payments of up to $1.8 billion, as well as tiered royalties.
    • “Novo Nordisk has exclusive rights to develop, manufacture, and commercialize UBT251 globally, excluding the Chinese mainland, Hong Kong, Macau and Taiwan.
    • “UBT251 differs from Novo Nordisk’s current portfolio as it takes a three-pronged approach to weight-loss and blood-sugar control. It combines a GLP-1–the same class of drugs as Novo Nordisk’s blockbuster Wegovy and Ozempic–with GIP to reduce appetite and blood sugar, and glucagon to prevent low blood-sugar levels.”
  • The Wall Street Journal adds,
    • 23andMe has filed for bankruptcy but assures customers that their genetic data will remain protected and managed in accordance with applicable laws.
    • Consumers can delete their 23andMe account data and destroy any stored genetic material by following the instructions provided in the article [and quoted below].
    • In the event of a bankruptcy sale, consumer data may be sold as part of the transaction, but protections may be in place to ensure responsible handling of sensitive information.
      • “Log in to your 23andMe account and go to the “Settings” section of your profile. Then scroll to a section labeled “23andMe Data” at the bottom of the page. Click “View” next to “23andMe Data.” You can download your genetic data if you want a copy for personal storage.
      • “After that, scroll to the “Delete Data” section and click “Permanently Delete Data.” You will receive an email from 23andMe. Follow the link in the data to confirm your deletion request. 
      • “Some customers who tried to delete their data Monday said they received error messages. Those trying to resolve the issue reported long customer service wait times. A company spokesman didn’t immediately respond to requests for comment.”
  • Fierce Healthcare fills us in one the latest Match Day for medical school seniors.
    • “Match Day 2025 has come and gone with the largest-ever total of applicants and positions as well as upticks in primary care and emergency medicine.
    • “The 73-year-old National Resident Matching Program’s (NRMP’s) breakdown of the annual event also outlined ongoing interest in obstetrics and gynecology—despite shifting reproductive care policies in the wake of the Dobbs decision—and a jump in participation among non-U.S. citizen international medical graduates.
    • “Applicants learned of their matches at 12:00 p.m. ET on Friday.
    • “All told, there were 52,498 total applicants, up 4.1% over last year, competing for 43,237 positions, up 4.2%.”

  • Beckers Payer Issues ranks payers by 2025 Part D membership
    • “Centene’s Medicare Part D enrollment is nearing 8 million members.
    • “According to CMS enrollment data from March 2025, Centene leads the nation in Medicare Part D membership with 7.92 million enrollees. The company has gained nearly 1 million members since the end of 2024, when its Part D enrollment was 6.93 million.”

Weekend update

David Ermer–CDC, Congress, COVID treatment, FDA, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call adds,
    • Both the House and Senate come back from recess this week to begin a busy three-week period that’s expected to focus on Republicans’ budget reconciliation agenda, including extending and expanding tax cuts and tightening immigration policy.
    • The top items on the House agenda this week, meanwhile, will include more measures to overturn Biden administration rules. And the Senate will continue to vote on more of President Donald Trump’s nominations. The headliners this week are the nominees to lead the National Institutes of Health and the Food and Drug Administration.
    • With a stopgap spending law now in effect through Sept. 30, the Republican majorities in both the House and Senate can fully turn their attention to their budget reconciliation agenda.
    • This work period on Capitol has just three weeks, followed by the traditional two-week recess that coincides with Easter and Passover. By then, House and Senate Republicans will want to make progress on resolving differences on how to execute the process that allows them to pass legislation without the risk of filibusters in the Senate.
  • Roll Call also gives us the 119th Congress in numbers, mid-March edition.
  • On Tuesday morning at 10 am, the House Oversight and Government Reform Committee will mark up the following batch of bills,
    • H.R. 1295, the Reorganizing Government Act of 2025; 2) H.R. 1210, the Protecting Taxpayers’ Wallet Act; 3) H.R. ___, the Preserving Presidential Management Authority Act; 4) H.R. 2174, the Paycheck Protection Act; 5) H.R. 2193, the FEHB Protection Act of 2025; 6) H.R. ___, the Federal Accountability Committee for Transparency (FACT) Act; 7) H.R. 2056, District of Columbia Federal Immigration Compliance Act; 8) H. Res. 187, Of inquiry requesting the President to transmit certain information to the House of Representatives referring to the termination, removal, placement on administrative leave, moved to another department of Federal employees and Inspectors General of agencies; 9) H. Res. 186, Of inquiry requesting the President to transmit certain documents to the House of Representatives relating to the conflicts of interest of Elon Musk and related information.
  • Healthcare Dive tells us,
    • “A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention is now scheduled to take place in April, a spokesperson for the Department of Health and Human Services confirmed.
    • “The Advisory Committee on Immunization Practices, or ACIP, had originally been scheduled to meet Feb. 26 to Feb. 28, but was unexpectedly delayed soon after Robert F. Kennedy Jr., a longtime critic of U.S. vaccination policies, took office as health secretary. At that time, an HHS spokesperson said the rescheduling was to allow extra time for public comment.” * * *
    • “ACIP, which includes outside vaccine experts as well as federal health officials, will now convene on April 15 and April 16, Andrew Nixon, HHS’ director of communications, wrote in an email to BioPharma Dive.” 
    • “A notice posted Friday ahead of publication Monday in the federal register indicated that advisers will discuss the current measles outbreak, as well as vaccines for COVID-19, human papillomavirus, monkeypox, respiratory syncytial virus and other pathogens.”
  • The New York Times reports,
    • “Robert F. Kennedy Jr., the nation’s health secretary, on Saturday instructed leaders of the nonprofit he founded to take down a web page that mimicked the design of the Centers for Disease Control and Prevention’s site but laid out a case that vaccines cause autism.
    • “The page had been published on a site apparently registered to the nonprofit, the anti-vaccine group Children’s Health Defense. Mr. Kennedy’s action came after The New York Times inquired about the page and after news of it ricocheted across social media.
    • “The page was taken offline Saturday evening.” 
  • Pharmacy Practice News informs us,
    • “The Drug Enforcement Administration (DEA) recently alerted healthcare providers to a concerning trend: hackers tapping into patient electronic health records (EHRs) to steal doctors’ DEA registration numbers. Armed with those numbers, the thieves have been able to generate tens of thousands of bogus prescriptions and sell them online, the agency explained in a YouTube video.
    • “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.”
    • “These activities can result in “a thousand fraudulent prescriptions using an unsuspecting doctor’s DEA number within a 14-hour time frame,” Ms. Hager said.”

From the public health and medical research front,

  • The New York Times reports, “Dementia May Not Always Be the Threat It Is Now. Here’s Why. The number of cases will increase, but the rates seem to be declining with every birth cohort that reaches advanced ages, researchers said.”
    • Eric Stallard, an actuary and co-director of the Biodemography of Aging Research Unit at Duke University, read the [recent dementia] study and thought the team “seemed very competent at their analysis” of individual risk.
    • But when it came to the projection that cases would double, which assumed that the incidence of dementia would remain stable over the next 40 years, “I don’t believe it,” Mr. Stallard said.
    • “The notion that the number of people with dementia will double over the next 25, 30 or 35 years due to the aging of baby boomers is widespread, it’s pervasive — and it’s wrong,” he added.
    • “He and two other Duke researchers recently published a commentary in JAMA pointing out that the age-specific prevalence of dementia in this country had steadily declined for 40 years.
    • “If your risks are lower than your parents’ risks and this trend continues, you won’t see the doubling or tripling of dementia that’s been projected,” said Dr. Murali Doraiswamy, director of the Neurocognitive Disorders Program at Duke and a co-author of the JAMA article.
    • “To be clear, experts agree that the number of people with dementia will climb in coming decades, simply because the disorder rises so steeply with age and the number of older adults in the United States will increase.
    • “But Mr. Stallard estimates that the increase will be more like 10 to 25 percent by 2050. “It will still be a significant challenge for the health system in the U.S.,” he said.”
  • The University of Minnesota CIDRAP lets us know,
    • Another study is raising questions about whether compliance with a federally mandated hospital protocol aimed at improving sepsis care and management is associated with better outcomes.
    • The study, published this week in JAMA Network Open, found that sepsis patients who received care that was noncompliant with the Centers for Medicare and Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) tended to be older, have more comorbidities, and have more complex clinical presentation than those who received compliant care. When those factors were accounted for, SEP-1 compliance was no longer associated with improved mortality.
    • The study comes on the heels of a systematic review and meta-analysis, published last month in the Annals of Internal Medicine, that found no evidence that SEP-1 compliance was associated with improved mortality.
  • and
    • “People who started taking the antiviral drug ensitrelvir within 72 hours after a household member tested positive for COVID-19 were significantly less likely to be infected, according to results from an international phase 3 clinical trial presented last week at the Conference on Retroviruses and Opportunistic Infections in San Francisco.
    • “Made by Japanese pharmaceutical firm Shionogi, ensitrelvir is approved in Japan for the treatment of mild to moderate COVID-19.  * * *
    • “In addition to vaccination, post-exposure prophylaxis with timely use of an oral antiviral would be a valuable way to help prevent COVID-19 illness in people who have been exposed, especially people at high risk for severe disease,” Frederick Hayden, MD, a University of Virginia School of Medicine professor emeritus who helped design the trial and presented the findings, said in a university news release.
    • “This is the first clinical trial of an oral antiviral drug to show significant protection against COVID-19 [infection],” he added. “If approved by the [US] Food and Drug Administration for this purpose, it would be an important addition to current preventive strategies.”
  • A Wall Street Journal reporter tells us “A Year After I Stopped Taking a [GLP-1} Weight-Loss Drug, I’ve Lost 20 More Pounds. I’m one of the millions of people trying to keep the weight off without taking expensive drugs like Mounjaro or Ozempic for life. It wasn’t easy, but I found ways.”
    • “My first mistake in stopping the medicine [after reaching his target weight in five months] was that I didn’t wean myself off it more slowly. I stopped cold turkey, and my hunger pangs and food noise came back with a vengeance. Some doctors and researchers have begun to recommend stopping more gradually, as well as taking appetite suppressants like phentermine to ease the transition. This has helped reduce weight regain in some patients.
    • “My second mistake was not having a structured nutrition plan at the ready. The medicine had helped winnow my bad habits down to a number I could actually manage, from perhaps 25 or 30 entrenched eating behaviors (really!) down to more like five or six (I still can’t shake my addiction to impulsive runs to the 7-Eleven, for example). But even a few bad habits—when they meet with what feels like insatiable hunger—can do a lot of damage.
    • “After a few months, I found a highly structured nutrition program, one with expert coaching that focused on a low-carb diet. While the transition was difficult, it eventually helped me bring my cravings under control. 
    • “Virta Health, a startup I turned to for a few months, has users test their blood daily. The results, which measure glucose levels and another indicator of dietary compliance, are beamed through an app to a nutrition coach. Being aware that someone was watching—and would know if I had cheated—was immensely helpful as I sought to improve my nutrition and manage hunger.
    • “Without wading into the nutrition wars over the keto or Atkins or Mediterranean diet or any other, I’ve found that I have generally been far less hungry when I’ve eaten more protein, fiber and healthy fats. Meanwhile, drastically limiting carbohydrates has had another benefit: forcing me to eat more vegetables. Gobs and gobs of them.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The Longevity Business Is Booming—and Its Scientists Are Clashing. The antiaging movement has raced ahead amid fierce debates; critics of a grandfather of the field, Leonard Guarente, include former protégés and rivals.”
  • and
    • “Doctors Are Just as Frustrated as You by Our Messed-Up Healthcare System. Trust between doctors and patients is fraying, but there are ways to mend it.”
      • “One of doctors’ biggest gripes: largely corporate institutions that effectively set patient quotas and require extensive documentation. One physician said he and other doctors are allowed 15 minutes with patients; exceeding that leads to poor performance reviews and “being out of compliance.”
      • “These doctors think patients lose trust because they don’t understand who or what is in control. “Physicians have lost autonomy,” says Dr. Corinne Rao, an internal medicine physician and hospitalist. “Their decisions are subject to the financial interests of their employer.” 
      • “Doctors also say that trust—and respect—go both ways. “It’s like a marriage,” says Dr.  James Schouten, a family physician. Each side has to give 100%. Implying that a loss of trust is entirely the doctor’s fault, he says, suggests the patient has no role in establishing or maintaining trust.
      • “They do, he and others say.”

Cybersecurity Dive

David Ermer–Cybersecurity–

From the cybersecurity policy and law enforcement front,

  • NextGov/FCW lets us know,
    • “A cornerstone federal program that certifies the security architecture of private sector cloud services for government use is expected to announce a fundamental overhaul to its processes on Monday [March 24], according to multiple people familiar with the matter.
    • “The moves, in the long term, are expected to automate many of the certification process steps for the Federal Risk and Authorization Management Program, or FedRAMP, which is used to ensure cloud providers meet strict cybersecurity requirements before government agencies can use their services, according to the people, who were granted anonymity to be candid about the forthcoming changes.
    • “FedRAMP has been a mainstay in government procurement for the last decade but has faced repeated complaints about the slow pace of cloud service approvals. FedRAMP has different approval levels that vary based on the sensitivity of the data a cloud service can handle, with higher levels requiring stricter security controls and generally longer review processes.”
  • and
    • “Despite goals set last year by the National Institute of Standards and Technology to process a backlog of unanalyzed cybersecurity vulnerabilities, the agency said it’s not expecting a slowdown anytime soon.
    • “The National Vulnerability Database — NIST’s cornerstone repository for researchers who use its contents and measuring tools to assess the dangers of cyber exploits — has been backed up with unanalyzed vulnerabilities since February last year. The scientific standards agency was projected to clear the logjam this month based on rates observed this past summer, Nextgov/FCW previously reported.
    • “But NIST said Wednesday that vulnerability submissions increased 32% in 2024 and prior processing rates from spring and early summer last year are no longer sufficient to keep up with incoming submissions. The backlog is still growing as a result.
    • “We anticipate that the rate of submissions will continue to increase in 2025. The fact that vulnerabilities are increasing means that the NVD is more important than ever in protecting our nation’s infrastructure. However, it also points to increasing challenges ahead,” an agency spokesperson said. “To address these challenges, we are working to increase efficiency by improving our internal processes, and we are exploring the use of machine learning to automate certain processing tasks.”
  • Per a March 21, 2025, HHS news release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Health Fitness Corporation (Health Fitness), located in Illinois, that provides wellness plans to clients across the country, resolving a potential violation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.” * * *
    • “The settlement resolves OCR’s investigation of Health Fitness, which OCR initiated after receiving four reports from Health Fitness, over a three-month period (October 15, 2018, to January 25, 2019), of breaches of unsecured protected health information.  Health Fitness filed the breach reports on behalf of multiple covered entities as their business associate.  Health Fitness reported that beginning approximately in August 2015, ePHI became discoverable on the internet and was exposed to automated search devices (web crawlers) resulting from a software misconfiguration on the server housing the ePHI. Health Fitness discovered the breach on June 27, 2018.  Health Fitness initially reported that approximately 4,304 individuals were affected and later estimated that the number of individuals affected may be lower.  OCR’s investigation determined that Health Fitness had failed to conduct an accurate and thorough risk analysis, until January 19, 2024, to determine the potential risks and vulnerabilities to the ePHI held by Health Fitness.
    • “Under the terms of the resolution agreement, Health Fitness agreed to implement a corrective action plan that OCR will monitor for two years and paid $227,816 to OCR.” * * *
    • The resolution agreement and corrective action plan may be found at:  https://www.hhs.gov/sites/default/files/health-fitness-ra-cap.pdf [PDF, 202 KB].

From the cybersecurity breaches and vulnerabilities front,

  • Cyberscoop tells us,
    • “Cybercriminals used information-stealing malware to a devastating effect last year, capturing sensitive data that fueled ransomware, breaches and attacks targeting supply chains and critical infrastructure, according to a new report.
    • “Infostealers were used to steal 2.1 billion credentials last year, accounting for nearly two-thirds of 3.2 billion credentials stolen from all organizations, Flashpoint said in a report released Tuesday. By targeting identity and access, cybercriminals stole 33% more credentials in 2024 compared to the previous year. More than 200 million credentials were already stolen in the first two months of this year.
    • “Infostealers are proving to be incredibly versatile, contributing to account takeover, increasing data breach totals, acting as initial access vectors to ransomware, as well as assisting in exploitation via vulnerabilities,” Ian Gray, vice president of intelligence at Flashpoint, said in an email.”
  • Security Week informs us,
    • “Browser security cannot be ignored. It’s where people spend most of their working day, and it’s where attackers focus most of their attacks.
    • “Statistics come from Menlo Security’s analysis of 750,000 browser-based phishing attacks targeting more than 800 entities detected over the last 12 months. This analysis reveals a 140% increase in browser phishing, including a 130% increase in zero-hour phishing attacks (effectively, a zero-day attack applied to phishing).
    • “The reasons for the growth are multiple: our growing reliance on the browser for much of our daily work, the prevalence of zero-day vulnerabilities, the increasing sophistication of the cybercriminal underworld, and, worryingly, the growing influence of gen-AI. Gen-AI is particularly concerning, both for its use today and its potential use in the future.
    • “Threat actors have advanced in speed and skills. They are using the same tools and infrastructure as professional engineers,” comments Andrew Harding, VP of security strategy at Menlo Security. “We’re seeing a dangerous combination of zero-day attacks, advanced social engineering techniques, sophisticated phishing techniques, and readily available phishing-as-a-service kits, all designed to infiltrate systems and steal valuable data.”
    • “He adds, “This trend is only poised to escalate dramatically in 2025 as attackers adopt AI to increase both scale and effectiveness.”
  • Dark Reading adds,
    • “A nearly decade-long malware campaign known as “DollyWay World Domination” has compromised more than 20,000 WordPress websites over the past eight years.
    • “GoDaddy published a report this week claiming multiple threat campaigns tracked by various security researchers since 2016 are actually one larger operation perpetrated by VexTrio, a massive cybercrime network that leverages traffic distribution systems (TDSs) and lookalike domains to deliver malware and scams.
    • “GoDaddy’s Denis Sinegubko wrote in the company’s research blog that the operation is tracked as DollyWay World Domination due to a string of code found in variations of the DollyWay malware: “define(‘DOLLY_WAY’, ‘World Domination’);”.
  • and
    • “Mobile phone jailbreaks are thriving, exposing users to anywhere between three- and 3,000-times greater risk of cyber compromise.
    • “Organizations already face a significant risk in bring your own device (BYOD) attacks. More than 70% of infected devices are personal, and a good chunk of organizations have watched as malware entered their walls through unmanaged devices belonging to employees.
    • “The risk is supercharged, though, when those devices are cracked. New data from Zimperium shows that rooted and jailbroken Android phones and iPhones are 3.5 times more likely to be infected with malware and 250 times more likely to be totally compromised.
    • “What we’ve seen is that the amount of jailbreaks and roots has decreased slightly in recent years,” says Kern Smith, vice president of global solutions engineering at Zimperium. However, he warns, “The risk of those has increased significantly. These jailbreaks and roots expose these devices to a much, much higher risk profile. And mobile devices in general are being exposed to a much higher risk profile today. So it becomes a multiplier effect.”
  • Per Fedscoop,
    • “The Federal Bureau of Investigation has warned federal employees that cybercriminals are attempting to steal their login credentials in connection to a widely used government financial services platform, according to a notice viewed by FedScoop. 
    • “Hackers are targeting the Employee Personal Page, or MyEPP page, which is operated by the National Finance Center (NFC), a financial and human resources shared service within the Agriculture Department used by 661,000 employees across the federal government for payroll. The site, which is used to manage salary and benefits information, is typically accessed through an online account or with Login.gov credentials. 
    • “According to the FBI, cybercriminals hope to trick federal employees by running advertisements on search engines that impersonate the NFC website. If they click on the ad, employees are brought to a “sophisticated phishing website” that looks similar to the actual MyEPP page that aims to capture their login credentials when users enter them.”
  • Per Bleeping Computer,
    • “Veeam has patched a critical remote code execution vulnerability tracked as CVE-2025-23120 in its Backup & Replication software that impacts domain-joined installations.
    • “The flaw was disclosed yesterday and affects Veeam Backup & Replication version 12.3.0.310 and all earlier version 12 builds. The company fixed it in version 12.3.1 (build 12.3.1.1139), which was released yesterday.
    • “According to a technical writeup by watchTowr Labs, who discovered the bug, CVE-2025-23120 is a deserialization vulnerability in the Veeam.Backup.EsxManager.xmlFrameworkDs and Veeam.Backup.Core.BackupSummary .NET classes.”
  • Cybersecurity Dive tells us,
    • At least 11 state-sponsored threat groups since 2017 have been actively exploiting a Microsoft zero-day flaw allowing for abuse of Windows shortcut files to steal data and commit cyber espionage against organizations in various industries.
    • Researchers from Trend Micro’s Trend Zero Day Initiative (ZDI) have identified nearly 1,000 malicious .lnk files abusing the flaw, tracked as ZDI-CAN-25373, which allows attackers to execute hidden malicious commands on a victim’s machine by leveraging crafted shortcut files.
    • “By exploiting this vulnerability, an attacker can prepare a malicious .lnk file for delivery to a victim,” according to a Trend Micro blog post on Tuesday. “Upon examining the file using the Windows-provided user interface, the victim will not be able to tell that the file contains any malicious content.”
    • “The malicious files delivered by attackers include various payloads, including the Lumma infostealer and Remco’s remote access Trojan (RAT), that expose organizations to risks of data theft and cyber espionage.”
  • CISA added five known exploited vulnerabilities to its catalog this week.
    • March 18, 2025
      • CVE-2025-24472 Fortinet FortiOS and FortiProxy Authentication Bypass Vulnerability
      • CVE-2025-30066 tj-actions/changed-files GitHub Action Embedded Malicious Code Vulnerability
        • Dark Reading discusses the Fortinent KVE here, and Cybersecurity Dive discusses the Github KVE here.
    • March 19, 2025
      • CVE-2025-1316 Edimax IC-7100 IP Camera OS Command Injection Vulnerability
      • CVE-2024-48248 NAKIVO Backup and Replication Absolute Path Traversal Vulnerability
      • CVE-2017-12637 SAP NetWeaver Directory Traversal Vulnerability
        • Hacker News discusses the Edimax KVE here and the NAVIKO KVE here. Cybersecurity News discusses the SAP KVE here.
  • Cybersecurity Dive adds,
    • Johannes Ullrich of the SANS Internet Storm Center reported exploitation attempts this week against two critical Cisco vulnerabilities that were initially disclosed in September. CVE-2024-20439 is a static credential vulnerability in the Cisco Smart Licensing Utility, and CVE-2024-20440 is an information disclosure flaw in the utility. 
    • It’s unclear if the exploitation was successful, but Ullrich noted the static credential for CVE-2024-20439 was previously published by a security researcher and could be used to remotely access affected devices.
    • Ullrich told Cybersecurity Dive the exploitation attempts likely originate from a smaller botnet, with activity spiking over the last week.
  • Fierce Healthcare lets us know,
    • “A new report by Clearwater Security found that incident response and resilience was a major issue for private equity-owned healthcare companies, which need to improve consistency in cybersecurity governance in light of their high-growth business model.
    • “The assessment found systemic gaps in security preparedness, as healthcare organizations need more documented policies for cybersecurity practices from provider practices to digital health companies. Private equity firms need to consider the cybersecurity risk profiles of companies when deciding whether to acquire them or merge them with other businesses, Clearwater writes.
    • “Because private equity firms prioritize rapid growth of their portfolio companies, Clearwater found that health IT infrastructures and cybersecurity practices often fall behind. A cybersecurity incident can devalue a company overnight or rack up regulatory fines, a dangerous prospect for PE firms.
    • “The report looked at consumer health companies, healthcare data and analytics companies and physician practices owned by private equity firms. It also evaluated pharma, biosciences and dental services companies.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “A Medusa ransomware campaign is using a malicious driver to disrupt and even delete endpoint detection and response (EDR) products on targeted organization networks.
    • “According to new research from Elastic Security Labs, the malicious driver, dubbed ABYSSWORKER, is deployed along with a packer-as-a-service called HeartCrypt to deliver Medusa ransomware. Elastic noted the driver was first documented in a ConnectWise post in January involving a different campaign of IT support scams using Microsoft Teams.
    • “In the Medusa ransomware attacks, Elastic discovered the malicious driver imitates a legitimate CrowdStrike Falcon driver and is using digital certificates from other companies to masquerade as a legitimate program. 
    • “All samples are signed using likely stolen, revoked certificates from Chinese companies,” Cyril François, senior research engineer at Elastic Security Labs, wrote in the blog post. “These certificates are widely known and shared across different malware samples and campaigns but are not specific to this driver.”
  • Per Bleeping Computer,
    • “Two malicious VSCode Marketplace extensions were found deploying in-development ransomware, exposing critical gaps in Microsoft’s review process.
    • “The extensions, named “ahban.shiba” and “ahban.cychelloworld,” were downloaded seven and eight times, respectively, before they were eventually removed from the store.
    • “It is notable that the extensions were uploaded onto the VSCode Marketplace on October 27, 2024 (ahban.cychelloworld) and February 17, 2025 (ahban.shiba), bypassing safety review processes and remaining on Microsoft’s store for an extensive period of time.”
  • Per Trend Research,
    • “Trend Research uncovered new versions of the Albabat ransomware. The development of these versions signifies the ransomware operators’ potential expansion of their targets from Windows to Linux and macOS. Research also reveals the group’s use of GitHub to streamline operations.
    • “Enterprises should remain vigilant against ransomware threats like Albabat as a successful attack can incur reputational damage, operational disruption, and financial losses once threat actors get a hold of and ransom critical data.
    • “To mitigate Albabat ransomware, organizations should have strong access controls for sensitive data, update and patch systems regularly and have proper backups.”
  • Per TechSpot,
    • “Akira, one of the most dangerous ransomware strains floating around the internet, just met its match — an Indonesian programmer armed with cloud computing and sheer determination.
    • “As first reported by TechSpot, Yohanes Nugroho successfully cracked Akira, a multiplatform ransomware that has been wreaking havoc since 2023. Used by cyber criminals to target hundreds of businesses, government agencies, and industries, Akira has helped its developers earn millions.
    • “While this isn’t the first time someone has found a way to break Akira’s encryption, what makes this case remarkable is that Nugroho did it alone — and in just over 10 hours.”

From the cybersecurity business and defense front,

  • NextGov/FCW reports,
    • “Google has moved to expand the security aspects of its cloud offering by agreeing to acquire Wiz in a $32 billion all-cash transaction, the global tech giant’s largest-ever.
    • “Wiz generates roughly $1 billion in annual revenue with FedRAMP-authorized cloud security products in areas such as prevention, active detection and response.
    • “Google sees the addition of Wiz as helping it support more agencies as they look to move their systems into multi-cloud and hybrid cloud environments.
    • “At the same time, software and (artificial intelligence) platforms are becoming deeply embedded across products and operations, bringing new and evolving risks for private enterprises, governments, and other public sector organizations,” Google Cloud CEO Thomas Kurian said in a release.”
  • Dark Reading explains why “Cyber Quality Is the Key to Security. The time to secure foundations, empower teams, and make cyber resilience the standard is now — because the cost of waiting is far greater than the investment in proactive security.”
  • TechTarget offers “13 API security best practices to protect your business. APIs are the backbone of most modern applications, and companies must build in API security from the start. Follow these guidelines to design, deploy and protect your APIs.”
  • Here are links to
    • Dark Reading’s CISO Corner
    • A HelpNetSecurity video about “Pay, fight, or stall? The dilemma of ransomware negotiations”
    • A Cyberscoop podcast in which its editor in chief “Greg Otto talks with FTI Consulting’s Allie Bohan exploring the challenges organizations face in maintaining effective communication during cyberattacks.”
    • The FEHBlog watched the seven-minute-long video and listed to the podcast while drafting this post and he found them worthwhile.

Friday Report

David Ermer–CDC, COVID-19, FDA, NIH, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us,
    • “President Trump on Thursday issued a presidential memorandum aiming to expand the power of the Office of Personnel Management to fire federal employees, alarming experts and federal employee groups.
    • “The memo, quietly published Thursday night alongside an executive order mandating agencies share data, particularly with Elon Musk’s Department of Government Efficiency, delegates to OPM the authority to fire federal employees based on “post-appointment conduct.”
    • “A federal employee’s appointment occurs at the conclusion of their one-year probationary period, when their full civil service protections kick in. Prior to that point, the Office of Personnel Management has authority to determine whether a federal job applicant or new hire is “suitable” for federal employment, which generally refers to questions of their “character or conduct.”
    • “But once an employee’s probationary period has ended, the authority to discipline or remove an employee rests solely with agency that employs them. Indeed, even if an employee threatens national security, only his or her employing agency may take action to suspend or remove them.
    • “Trump’s memo expands who may remove employees for “conduct and character” reasons to include OPM and tasks the HR agency with writing the regulations governing the agency’s ostensibly new power. Agencies may make referrals to OPM for approval, or the OPM director may reach down and order individual agencies to discipline or fire workers.”
  • Fierce Healthcare informs us,
    • “Former Republican House Representative Michael Burgess, M.D., is a top choice for the White House’s second try at a Centers for Disease Control and Prevention (CDC) director nomination, according to a Reuters report citing three anonymous sources.
    • “One of the sources described Burgess to Reuters as the likely nominee but said that the decision is not yet final. The administration has not yet commented on its next choice for the role.
    • “Burgess, 74, practiced as an obstetrics and gynecology doctor before stepping into Capitol Hill in 2003. He chose not to seek reelection this past year.”
  • Healthcare Finance offers more details on the terrorist threat against hospitals.
    • On March 18, user @AXactual made a post on X with details related to the active planning of a coordinated, multi-city terrorist attack on United States health sector organizations, according to the joint threat bulletin.
    • The terrorist attack on hospitals would reportedly be by ISIS-K, a division of the jihadist group Islamic State, according to The HIPAA Journal. The post was added to the X account of American Kinetix, which claims to be a Christian company in the United States that consists of JSOC (Joint Special OperationsCommand), the CIA and combat veterans, The HIPAA Journal said.
    • American Kinetix said it had received reports of possible pre-attack surveillance at hospitals.” * * *
    • “The primary targets would be mid-tier cities with low-security facilities, the joint threat bulletin said. With the information claiming multiple simultaneous targets, attackers would likely select health sector facilities with visibly weak security and conduct prior planning coordination.” 
  • The American Hospital Association (AHA) News lets us know,
    • “The Drug Enforcement Administration and Department of Health and Human Services yesterday announced that the effective date for the final rule regarding telemedicine prescribing of buprenorphine will be further delayed from March 21 to Dec. 31. The original effective date was Feb. 18 before the first delay to March 21. As outlined in the Jan. 20 White House memorandum announcing the regulatory freeze, the agencies decided to delay the implementation of rules to review any questions of fact, law and policy.
    • “The waiver provisions outlined in the third extension of telemedicine flexibilities for prescribing controlled substances will remain in effect to waive in-person visit requirements through Dec. 31.
    • “Once implemented, the final rule for the telemedicine prescribing of buprenorphine will enable practitioners to prescribe a six-month initial supply of Schedule III-V medications to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation.”
  • STAT News points out,
    • “The Food and Drug Administration cleared Alnylam Pharmaceuticals’ treatment for a progressive heart condition Thursday, setting it up to compete with therapies from BridgeBio and Pfizer.
    • “Alnylam’s drug, vutrisiran, was approved for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce cardiovascular-related death and hospitalizations. This indication was widely expected among investors and is similar to the indications given for competing therapies.
    • “The treatment, which will be sold under the brand name Amvuttra, was additionally approved to reduce urgent heart failure visits.”
  • BioPharma Dive adds,
    • “Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double the cost of other treatments available for the condition, company executives said Thursday.
    • “The price of the drug, Amvuttra, was revealed on a Thursday evening conference call discussing the Food and Drug Administration’s decision to clear the treatment in people with transthyretin amyloidosis, or ATTR, cardiomyopathy. Alnylam already markets the medicine for people with a form of the condition that affects the nerves but has long looked to an approval in cardiomyopathy as the kind of revenue driver that can help it turn a consistent profit.
    • Alnylam will begin selling Amvuttra as two other treatments, Pfizer’s tafamidis and BridgeBio Pharma’s Attruby, are already accessible. Both tafamidis and Attruby are taken orally, while Amvuttra is injected. Although none of the drugs have been tested directly against another and cross-trial comparisons come with caveats, Amvuttra’s benefits also don’t appear to be clearly superior to its rivals.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for five consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels and emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for five consecutive weeks. Data to date suggest the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota CIDRAP reports,
    • “The Texas Department of State Health Services (TDSHS) today reported 30 more cases in a measles outbreak in the western part of the state near the New Mexico border, as the New Mexico Department of health added 4 new cases to its total, pushing the outbreak total to 351.
    • “Meanwhile, as global cases surge, a handful of states reported new cases in people who had connections to international travel. In a weekly update today, the Centers for Disease Control and Prevention (CDC) said it has received reports of 378 cases this year, well past the 285 cases reported for all of 2024. 
    • “The cases are from 18 jurisdictions, and 90% are linked to three outbreaks. The CDC’s update includes the first cases of the year from Kansas, Ohio, and Michigan. Kansas last week reported its first measles infection since 2018, and media reports say at least six cases have been reported in the southwest part of the state in Grant and Stevens counties.”
  • The AP relates,
    • “A common blood test may miss ovarian cancer in some Black and Native American patients, delaying their treatment, a new study finds. It’s the latest example of medical tests that contribute to health care disparities.
    • “Researchers have been working to uncover these kinds of biases in medicine. Recently, the Trump administration’s crackdown on diversity, equity and inclusion has jeopardized such research as universities react to political pressure and federal agencies comb through grants looking for projects that violate the president’s orders.
    • “Native American women have the highest rate of ovarian cancer. Black women with ovarian cancer have lower rates of survival compared to white women. Finding ovarian cancer early can lead to better chances of survival.
    • ‘The new study, supported by grants from the National Cancer Institute and published Thursday in JAMA Network Open, looked at a test called CA-125. The test measures a tumor marker in the blood, and doctors use it to determine if a woman with a suspicious lump should be referred to a cancer specialist.” 
  • Per a National Cancer Institute news release,
    • “When people who smoke are screened for lung cancer, studies have suggested that the screening visit can be an opportune time for health care providers to offer them ways to stop smoking.
    • “Results from a large clinical trial now show that a comprehensive program that integrates intensive counseling and cessation medications may be a particularly effective way of accomplishing that goal.
    • “The study included more than 600 adults who were current smokers. By the end of the 3-month treatment period, nearly 40% of those randomly assigned to participate in an intensive cessation program had quit smoking and had not started up again. In contrast, about 25% of those referred to a tobacco use quitline hit that same benchmark.
    • “The results were published March 1 in JAMA Internal Medicine. 
    • “According to the study’s lead investigator, Paul Cinciripini, Ph.D., of the University of Texas MD Anderson Cancer Center, the findings confirm that when people who smoke are being screened for lung cancer, it “presents a critical opportunity” to support them in quitting. The type of support, however, appears to be particularly important, Dr. Cinciripini said.
    • “Another important takeaway is “the importance of having [dedicated cessation specialists] be a part of [cessation] treatment,” said Carolyn Reyes-Guzman, Ph.D., of NCI’s Tobacco Control Research Branch, which funded the study.” 
  • Per Healio,
    • “Risk for moderate to severe depressive symptoms during pregnancy varied widely across 20 different racial and ethnic groups, suggesting women from different cultural backgrounds view and report depression symptoms differently, data show.
    • “Our study found differences among racial and ethnic subgroups in several aspects of prenatal depression, including the likelihood of receiving a diagnosis and reporting symptoms when screened in prenatal care,” Kendria Kelly-Taylor, PhD, a research fellow with Kaiser Permanente Northern California Division of Research, told Healio. “We found most of the [racial] groups were less likely to have a diagnosis of prenatal care and more likely to report moderate-to-severe depressive symptoms when screened. Previous research provides some possible reasons for these findings, which include differences in how patients in various racial and ethnic subgroups experience symptoms, view their symptoms, and their comfort in discussing them with a clinician or having a diagnosis in their medical record.”
  • HealthDay reports,
    • “The total injury death rate in the United States increased from 2013 through 2021, then declined through 2023, according to a March data brief published by the National Center for Health Statistics.
    • “Sally C. Curtin, from the National Center for Health Statistics in Hyattsville, Maryland, presents trends in injury death rates overall and by three leading intents (unintentional, suicide, and homicide) for 2003 to 2023.
    • “Curtin found that the total age-adjusted injury death rate increased 21 percent from 2013 to 2019 (58.8 to 71.2 per 100,000 standard U.S. population) after a period of stability from 2003 to 2013; there was an additional 25 percent increase through 2021 (89.0), followed by a 4 percent decline through 2023 (85.3). From 2003 to 2019, there was a threefold increase in unintentional drug overdose death rates, followed by a 58 percent increase through 2022 and a 4 percent decline through 2023. From 2006 to 2018, there was an increase in firearm-involved suicide death rates, followed by a decline in 2019 and an increase through 2021; rates remained stable through 2023. The firearm-involved homicide death rate declined from 2003 to 2014, then increased through 2021, and declined through 2023.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Johnson & Johnson JNJ said it is increasing U.S investments to more than $55 billion over the next four years, boosting spending on manufacturing, R&D and technology in a move it says will create jobs and help speed up drug discovery and development.
    • “The healthcare conglomerate said Friday that the investment represents a 25% increase from the previous four-year period.
    • “Part of that will go toward four new manufacturing facilities in the U.S., and the expansion of existing sites, J&J said, adding that it is kick-starting the investment by breaking ground on a North Carolina biologics manufacturing facility on Friday.”
  • Beckers Hospital Review notes,
    • “East Ohio Regional Hospital, a 140-bed healthcare facility in Martins Ferry, has closed, local media outlets reported. 
    • “Signs posted at EORH entrances March 20 said “Hospital closed! Please go to the nearest hospital Trinity, Reynolds or Wheeling!” according to the outlets, including The Intelligencer and NBC and Fox affiliate WTOV.
    • “The closing is the latest chapter for the struggling hospital and comes as workers reported having not received their most recent paychecks. Employees were not paid as scheduled March 7 and said they remained unpaid as of March 20, according to The Intelligencer.”
  • Per Beckers Payer Issues,
    • The healthcare industry needs to have more conversations about patient experience, AI and preventive care, according to payer executives. 
    • Becker’s connected with 25 leaders to learn more about what they say is underdiscussed in healthcare. 
    • The leaders’ observations can be found in the article.

Thursday Report

David Ermer–ACA, CDC, FDA, Generative AI, Government Contracting, HSA, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Mark Tegethoff on Unsplash

Happy first day of Spring!

From Washington, DC,

  • Per Becker’s Health IT,
    • The American Hospital Association and Health-ISAC are alerting hospitals to a social media post alleging plans for a coordinated, multi-city terrorist attack on healthcare facilities in the coming weeks.
    • The organizations said they are sharing the information as a precaution and remain in close contact with the FBI. They plan to provide updates as more details emerge, according to a March 20 news release.
    • The AHA and Health-ISAC said there is no information available to corroborate or discount the threat’s credibility.
    • “Generally, foreign terrorist groups do not publicize their upcoming attacks. However, this widely viewed post may encourage others to engage in malicious activity directed toward the health sector, so threats of this nature should be taken seriously,” the news release reads. “Security teams should review emergency management plans and spread awareness of the potential threat internally.”
  • Health Affairs Forefront offers reflections on the 15th anniversary of the Affordable Care Act, which will be marker on March 23, and an idea about how to add high deductible plans with health savings accounts to marketplace plans, which in the FEHBlog’s view is a great idea.
  • The American Hospital Association News tells us,
    • The Equal Employment Opportunity Commission and the Department of Justice yesterday announced the release of two documents warning against unlawful discrimination related to diversity, equity and inclusion in the workplace. A one-pager, “What To Do If You Experience Discrimination Related to DEI at Work,” and a Q&A, “What You Should Know About DEI-Related Discrimination at Work,” are based on Title VII, existing EEOC policy and Supreme Court precedent. 
    • “DEI is a broad term that is not defined in Title VII of the Civil Rights Act of 1964,” the agencies said. “In the past five years, DEI policies, programs, and practices have become increasingly prevalent in many of our nation’s largest and most prominent businesses, universities, and cultural institutions. The widespread adoption of DEI, however, does not change longstanding legal prohibitions against the use of race, sex, and other protected characteristics in employment.”
  • and
    • The Food and Drug Administration today issued an alert on a potentially high-risk issue with Calyxo CVAC Aspiration Systems. In patients who have thick fluid in their kidneys at the start of the procedure, the system can cause reduced fluid overflow, potentially leading to excessive pressure in the kidneys. Serious death or injury could occur if the increased pressure is not addressed. Calyxo has reported one death associated with the issue.
  • Per an HHS news release,
    • “Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potential health risks of contaminants in human foods. Chemical contaminants include a broad range of chemical substances that may be present in food and that have the potential to cause harm.”
  • The President today signed an executive order implementing the following policy,
    • “The Federal Government spends approximately $490 billion per year on Federal contracts for common goods and services — the types of goods and services purchased by nearly every executive department and agency (agencies) — making it the largest buyer of goods and services in the world.  As a matter of sound management, these standardized procurement functions should be carried out in the most efficient and effective manner possible for the American taxpayer. The General Services Administration was established in 1949 through the Federal Property and Administrative Services Act, 40 U.S.C. 101 et seq., to provide “an economical and efficient system” for the core procurement services for agencies (40 U.S.C. 101).  It is time to return the General Services Administration to its original purpose, rather than continuing to have multiple agencies and agency subcomponents separately carry out these same functions in an uncoordinated and less economical fashion.”
  • Federal News Network discusses the EO here.
  • Bloomberg Law reports,
    • “The US Agriculture Department is preparing to spend as much as $100 million to combat bird flu by soliciting proposals for new poultry vaccines and virus detection methods.
    • “Officials plan to announce the funding opportunity for companies including vaccine manufacturers on Thursday, according to a USDA email obtained by Bloomberg Government and verified by two congressional staff granted anonymity to discuss the not-yet-public plan. 
    • “The solicitation announcement is expected to seek proposals that prevent, treat, or research bird flu infections, according to the Wednesday email signed by Tucker Stewart, the deputy assistant secretary for USDA’s Office of Congressional Relations.
    • “The money would be the agency’s latest step toward rolling out a $1 billion bird flu response plan that Agriculture Secretary Brooke Rollins announced in February. Rollins has downplayed the role vaccines will play in fighting the virus since announcing the strategy, citing high costs and low effectiveness rates.” 

From the public health and medical research front,

  • NBC News informs us,
    • “Prescriptions for ADHD medications have been spiking in recent years, with the sharpest increase among middle-aged and older women. They’re also the least likely to misuse the prescription stimulants, a new study found.
    • “The rise among women ages 35 to 64 has been substantial. At the end of 2022, 1.7 million women in this age group were prescribed stimulants such as Adderall and Ritalin for ADHD, compared to 1.2 million prescriptions in 2019.
    • “There’s been an overall jump in ADHD prescriptions since the pandemic and the rise of telehealth. The new analysis, published in JAMA Psychiatry by researchers at the National Institute on Drug Abuse, also looked into how the medications are being misused — that is, taking more of the drugs than prescribed, taking them at times that differed from what the doctor ordered or using medication from someone else’s prescription.” 
  • Cardiovascular Business points out,
    • “Using cannabis significantly raises a person’s myocardial infarction risk, even if they are young and otherwise quite healthy, according to the research team behind two new studies. The first is a retrospective analysis that was just published in JACC Advances, while the other is a meta-analysis being presented at ACC.25, the American College of Cardiology’s annual conference. 
    • “Asking about cannabis use should be part of clinicians’ workup to understand patients’ overall cardiovascular risk, similar to asking about smoking cigarettes,” Ibrahim Kamel, MD, clinical instructor at the Boston University Chobanian & Avedisian School of Medicine and the lead author of both studies, said in a statement. “At a policy level, a fair warning should be made so that the people who are consuming cannabis know that there are risks.”
    • “Kamel et al. performed a retrospective study of more than 4.6 million adults 50 years old or younger. All participants were free of significant cardiovascular comorbidities with no prior coronary artery disease. The average follow-up period was more than three years. Overall, the group found that cannabis use significantly increased a person’s risk of a myocardial infarction, ischemic stroke, heart failure and cardiovascular death.”
  • Per Healio,
    • “Markers of subclinical heart damage were observed among individuals who smoke cigarettes, even decades after quitting, according to a study published in the Journal of the American College of Cardiology.
    • “New data from the Cross-Cohort Collaboration-Tobacco Work Group showed that cigarette smoking was associated with elevated markers of inflammation, thrombosis and atherosclerosis, all of which decreased after cessation, except for coronary calcium, which remained elevated 30 years later.
    • “Understanding the mechanisms of smoking-related injury and the most sensitive biomarkers of subclinical harm is critical to clinical trial planning and tobacco regulatory policy, and might be important for planning studies and informing regulatory of new and emerging tobacco products as well,” Michael J. Blaha, MD, MPH, professor of medicine and director of clinical research at the Ciccarone Center for the Prevention of Cardiovascular Disease at Johns Hopkins Medicine, told Healio. “The degree to which new and emerging tobacco products affect these same biomarkers will need to be explored.”
  • On the bright side, the Wall Street Journal illustrates how “Drug Overdoses Are on the Decline, in Charts. Fatalities from drugs including fentanyl are down from recent peaks.”
  • The AP reports,
    • “Nestle USA is recalling certain batches of its Lean Cuisine and Stouffer’s frozen meals for possible contamination with “wood-like material” after a report of potential choking. 
    • “The recall applies to limited quantities of meals with best-before dates between September 2025 and April 2026. They include Lean Cuisine Butternut Squash Ravioli, Lean Cuisine Spinach Artichoke Ravioli, Lean Cuisine Lemon Garlic Shrimp Stir Fry and Stouffer’s Party Size Chicken Lasagna. The products were distributed to major stores in the U.S. between September 2024 and this month. No products beyond those listed are affected. 
    • “Nestle officials said they are working with the U.S. Food and Drug Administration and the Agriculture Department and investigating the source of the wood-like material. The company said it launched the recall after consumers reported the problem, including at least one potential choking incident.”
  • Per Healio,
    • “Adults with insulin-treated type 2 diabetes had greater HbA1c reductions and larger improvement in time in range with use of an automated insulin delivery system compared with standard care, according to findings from a new trial.”
  • Per BioPharma Dive,
    • “On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the company believes will help secure a broad approval for a successor drug to its blockbuster gene therapy Zolgensma.
    • “The drug, code-named OAV101, shares the same active ingredient as Zolgensma, which in 2019 gained U.S. approval for the treatment of a rare, muscle-wasting illness known as spinal muscular atrophy. Zolgensma, though, is injected into the veins, and is only cleared for use in patients under two years of age. Novartis has spent years trying to show OAV101, which is shot right into the spine, can be a safe and effective therapy for older kids.”

From the artificial intelligence front,

  • STAT News reports,
    • A panel of experts at a leading specialty society announced in a new clinical guideline that they have decided not to decide whether to recommend AI-assisted colonoscopies.
    • “After reviewing studies and using existing information to model outcomes, experts enlisted by the American Gastroenterological Association determined that using AI definitely increases adenoma detection rate (ADR), or colonoscopies that find polyps. But they figure, with low certainty, that using AI in screening only leads to 2 fewer colorectal cancer-related deaths per 10,000 people over 10 years. Citing a close call and fuzzy evidence, the panel decided not to issue a recommendation.”
  • MedTech Dive explains, “Quest, Google team on gen AI; GE Healthcare plans autonomous imaging; GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.” For details read the article.
  • RAND concludes “AI Models Are Skilled at Identifying Appropriate Responses to Suicidal Ideation, but Professionals Still Needed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “GE HealthCare launched its Invenia Automated Breast Ultrasound Premium system Thursday that features artificial intelligence tools.
    • “The system, which has premarket approval from the Food and Drug Administration, is designed to help better detect breast cancer in women with dense breasts.
    • “Detecting breast cancer in this patient population with mammography can be difficult for radiologists because both dense tissue and cancerous masses appear white in images, according to the American Cancer Society.
    • “Automated breast ultrasound produces clearer and more detailed images and has been shown in multiple studies to improve the sensitivity of detecting invasive cancer in dense breasts when used alongside mammography.”
  • and
    • “Post-acute care technology companies Medalogix and Forcura announced their merger Wednesday.
    • “The companies aim to create a platform for streamlining patient care transitions and better connect post-acute care providers to the broader healthcare system. Berkshire Partners, a Boston-based private equity firm, will be the majority owner of the combined company, which is not yet named, according to a news release. Chicago-based private equity firm The Vistria Group will be the largest minority shareholder, the release said.
    • “Financial terms of the deal were not disclosed.”
  • Per Fierce Pharma,
    • “Optum Rx is shifting its payment models to better meet the needs of pharmacies and consumers, the pharmacy benefit manager announced Thursday.
    • “The company said it will shift to a cost-based model, which will better align with “the costs pharmacies may face due to manufacturer pricing actions.” The PBM expects the change to be a positive one for the more than 24,000 independent and community pharmacies it works with, along with its members.
    • “Optum said it will begin to roll out the updated models now and intends to have a full implementation in place by January 2028.”
  • MedCity News lets us know,
    • “Evvy, a women’s health company, is now offering fertility insights through its vaginal microbiome test, the company announced on Tuesday.
    • “New York City-based Evvy is a direct-to-consumer company. Its vaginal microbiome test, starting at $129, checks for bacteria and fungi (or microbes) in people’s vaginas. After taking the test, people receive a report that explains the microbes found in the vagina and the health conditions related to those microbes. Based on the results, consumers receive a customized treatment plan and a one-on-one virtual session with a coach.
    • “Now, the test results include a section on fertility insights. Users of the test receive a “protective score,” which is a measure of protective bacteria like Lactobacillus. This is associated with improved fertility, lower inflammation and better pregnancy outcomes.”
  • Per BioPharma Dive,
    • “Sanofi agreed to pay $600 million for a therapy in early human testing that may have the ability to “reset” a patient’s immune system and ward off debilitating inflammatory diseases.
    • “The treatment, dubbed DR-0201, is known as a bispecific myeloid cell engager. It’s designed to engage specific immune cells that can prompt the body to deplete disease-causing B cells. It’s shown promise in preclinical and Phase 1 studies, Sanofi said. 
    • “As part of the deal announced Thursday, Sanofi agreed to pay as much as $1.3 billion more to privately held Dren Bio if DR-0201 succeeds in reaching certain development and launch goals. The French drugmaker expects to take over the DR-0201 program in the second quarter.”

Midweek Report

David Ermer–Congress, FDA, Medical / Rx research, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Govexec informs us,
    • “President Donald Trump on Friday repealed two late-issued Biden regulations and will likely revoke more in the coming weeks. 
    • “The Congressional Review Act enables Congress and the president, if they are in agreement, to overturn by simple majority regulations that were promulgated during the 60 Senate session days or 60 legislative House days before a session of Congress adjourns, whichever is earlier. In this case, Trump and congressional Republicans can use the CRA to override rules finalized on or after Aug. 16, 2024. 
    • “The resolutions, both of which Congress approved with some Democratic support, would:
    • S.J. Res 11, revoke a September Bureau of Ocean Energy Management rule that required oil and gas companies working on the Outer Continental Shelf to submit a report identifying potential archaeological resources on the sea floor that could be affected by such development. 
    • “H.J. Res 35, repeal a November EPA rule specifying requirements under the Methane Emissions Reduction Program, through which the agency charges oil and gas companies for methane and other greenhouse gas emissions if they surpass certain thresholds. 
    • Six other measures to block late Biden rules have been approved in either the House or Senate, including resolutions targeting EPA emission standards for rubber tire manufacturing (H.J. Res 61), IRS reporting requirements for digital asset sales (S.J. Res 3 / H.J. Res 25) and Energy Department conservation standards for consumer gas-fired instantaneous water heaters (H.J. Res 20). 
    • “In total, 57 CRA resolutions have been introduced, according to a tracker from the Center for Progressive Reform. The resolutions’ most frequent target is rules from the EPA.” 
  • Per MedTech Dive,
    • “Monogram Technologies received Food and Drug Administration 510(k) clearance for its mBôS TKA System for total knee replacements and will now work toward commercializing the system, the Austin, Texas-based company said Monday.
    • “Monogram aims initially to place the robot with surgeons who are key opinion leaders in strategic geographies as it establishes clinical experience and demonstrates the platform in real-world settings. It plans to integrate recent upgrades to the robot’s cutting system and other enhancements into the cleared mBôs device over the coming months.”

From the judicial front,

  • Per FiercePharma,
    • “Previously at the epicenter of the U.S. opioid crisis, Purdue Pharma is looking to reenter the public lexicon as a new public benefit company. After a prior bankruptcy settlement was nixed by the Supreme Court, the drugmaker has come back with a new plan that would deliver more than $7.4 billion to its creditors.
    • “The company hopes to emerge from the Chapter 11 bankruptcy process it entered in 2019 with a new reorganization plan, filed Wednesday with the U.S. Bankruptcy Court for the Southern District of New York. The plan lays out more than $7.4 billion in payments to compensate opioid victims and “abate the opioid crisis,” Purdue said in a press release.
    • “That $7.4 billion sum includes available company cash and payments by the Sacklers, the billionaire family who helmed the company until 2019.” * * *
    • “The plan is subject to confirmation by the bankruptcy court, which is expected to hold a hearing in May. After a potential court approval, Purdue would solicit votes to finalize the plan.”

From the public health and medical research front,

  • STAT News reports,
    • “The expanding measles outbreak that has spread from West Texas into New Mexico and Oklahoma could take a year to contain, a public health leader in the area where the outbreak started warned on Tuesday.
    • “Katherine Wells, director of public health for the city of Lubbock, said the outbreak is still growing, with capacity to transmit both locally and further afield through spread to pockets of unvaccinated individuals. Though the response teams have been stressing the importance of vaccination, uptake of vaccines “has definitely been a struggle,” Wells said.”
    • “This is going to be a large outbreak. And we are still on the side where we are increasing the number of cases, both because we’re still seeing spread and also because we have increased testing capacity, so more people are getting tested,” Wells said during a press conference organized by the Big Cities Health Coalition, a forum for leaders of metropolitan health departments. 
    • “I’m really thinking this is going to be a year-long in order to get through this entire outbreak,” she said.”
  • AHA News relates,
    • The U.S. birth rate fell 2% in 2023 to about 3.6 million, according to final data released March 18 by the Centers for Disease Control and Prevention. The cesarean delivery rate increased 1% in 2023 to 32.3%. The preterm birth rate was 10.41%, essentially unchanged from 2022. Medicaid was the source of payment for 41.5% of births, a slight increase from 2022 (41.3%).
  • Health Day adds,
    • “Young American women are greeting the prospect of pregnancy with a decided “meh,” driving down U.S. fertility rates, a U.S. Centers for Disease Control and Prevention (CDC) study says.
    • “The actual number of U.S. births declined by 14% between 1990 and 2023, and the fertility rate went down by 23%, according to a paper in the CDC’s National Vital Statistics Reports.
    • “This drop in fertility occurred mainly among women younger than 30, statistics show.
    • “Women under 30 accounted for 7 in 10 births (70%) in 1990. But by 2023, this age group accounted for less than half of U.S. births (49%).
    • “The sharp drop in births among young women overwhelmed a slight increase in birth rates among women 30 and older, researchers reported.
    • “In summary, the decline in fertility rates over the past few decades results from declining rates among females younger than 30 that are offset somewhat by smaller increases in rates among older women,” the research team led by senior researcher Brady Hamilton of the CDC’s Division of Vital Statistics concluded.”
  • The Washington Post reports,
    • “Pollen seasons are not the same across the United States. Now, a report released Tuesday by the nonprofit Asthma and Allergy Foundation of America shows where allergy sufferers had it the worst last year.
    • “About a quarter of U.S. adults suffer from seasonal allergies — many experiencing itchy and watery eyes, a scratchy throat and an ever-running nose. Pollen exposure is now lasting longer and intensifying nationwide, data shows, as warmer temperatures take over more of the year. But for some areas, the changes are more dramatic.
    • “The report ranks the top 100 largest U.S. cities by how challenging they were for allergy sufferers to live in last year. These “allergy capitals” are based not only on pollen counts, but also on the use of over-the-counter medication and the number of allergy physicians in the area.”
  • MedPage Today points out,
    • “The simple addition of a deadline to a mailed invitation for fecal immunochemical test (FIT) colorectal cancer (CRC) screening resulted in improved return rates, the randomized TEMPO trial showed.
    • “Across eight study arms, the highest return rate was seen with a 2-week deadline without a problem-solving planning tool, with 68% of usable FIT kits returned by 3 months compared with 66% in the control group (no deadline and no planning tool), reported Kathryn Robb, PhD, of the University of Glasgow in Scotland, and colleagues in The Lancet.”
  • Per BioPharma Dive,
    • “Prime Medicine will test its gene editing technology as treatment for a rare liver and lung disorder, revealing on Tuesday plans for a research program in alpha-1 antitrypsin deficiency. 
    • “The company, which is developing “prime editing” as a way to flexibly edit genes without cutting through both strands of DNA, expects to ask regulators next year for permission to begin human testing of the new treatment. 
    • “The program in alpha-1 antitrypsin deficiency, or AATD, is the first new target Prime has picked since significantly paring back its research plans last September. As with other developers of genetic medicines, Prime has faced investor scrutiny on the pace and cost of its research.:

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Cigna has officially sealed the deal on the $3.3 billion sale of its Medicare business to Health Care Service Corporation.
    • “HCSC acquired Cigna’s Medicare Advantage, Part D, supplemental benefits and CareAllies units as part of the deal.
    • “While it will no longer operate the Medicare unit directly, Cigna said it will continue to provide pharmacy benefit management and other services through its Evernorth division, as part of an agreement with HCSC.”
  • Healthcare Dive lets us know,
    • “Optum Rx is moving to eliminate prior authorizations on dozens of drugs, the UnitedHealth-owned pharmacy benefit manager said Wednesday, paring back a key pain point for physicians and patients at a time of widespread discontent with middlemen in the healthcare industry.
    • “Starting May 1, Optum Rx will eliminate reauthorizations — when drugs already being used by a patient need to be reapproved by their plan — for roughly 80 drugs. The program will cut up to 25% of all reauthorizations, or 10% of prior authorizations overall, the PBM said.
    • ‘The drugs included treat high cholesterol, lung disease, multiple sclerosis, migraines and more. Optum Rx said it plans to apply the policy to additional drugs in the future.”
  • The Wall Street Journal reports,
    • “Today was supposed to mark the beginning of the end for cheaper, knockoff versions of hot weight-loss drugs. The Food and Drug Administration wants bulk production of the copycats to stop—starting Wednesday for pharmacy-prepared versions of Zepbound and later in the spring for knockoffs of Ozempic and Wegovy.
    • “But telehealth companies and pharmacies that have fueled wide use of copycats have other plans.
    • “Telehealth platform Hims & Hers Health says it will keep offering pharmacy-made, or compounded, versions of Ozempic and Wegovy tweaked to individual prescriptions. And some of the pharmacies making the GLP-1 drug copycats will continue, according to people familiar with the industry.
    • “The firms are seeking to take advantage of current law, which allows compounding pharmacies to make special, individualized versions of drugs that aren’t available commercially. Telehealth firms and pharmacies instead intend to sell versions of the obesity drugs tailored for specific patients whose doctors say they need a different dosage than one of the original drugs or a version with extra vitamins added. 
    • “A lot of these patients won’t be able to afford switching over to a brand-name medication,” said Dr. Taylor Kantor, a co-founder of Ivim Health, a telehealth platform offering obesity drugs. “We’re trying to make sure those patients aren’t left in the dust.”
  • MedTech Dive tells us,
    • Orthopedic device companies gathered last week in San Diego to demonstrate their latest innovations and discuss industry trends at the American Academy of Orthopaedic Surgeons’ annual meeting.
    • Robotic surgery systems remained a focus at the event, with Stryker showcasing the newest version of its Mako surgical robot and Johnson & Johnson displaying a feature that was cleared for its Velys robot last year, allowing it to be used for partial knee replacements. 
    • Company executives also discussed economic trends, expecting procedure volumes and hospital equipment purchases to remain steady despite financial pressures.
    • [The article includes] four takeaways from the event
  • Fierce Healthcare notes,
    • “Instacart is rolling out multiple features it says will make it easier for users to make healthy choices, headlined by its artificial-intelligence-powered Smart Shop.
    • “The tool seeks to make grocery shopping through the platform more “intuitive,” according to an announcement from the company, while leveraging AI and machine learning to personalize the experience. Users can select from 14 dietary preference options, including gluten-free, low-calorie or pescatarian, to tailor their shopping.
    • “For example, take an individual looking for foods low in carbohydrates. There are many food options that are naturally low-carb, which can make recommendations difficult. Through the AI tech, Smart Shop is able to filter these options and delineate the difference between items that are deliberately chosen to be low in carbs.”

Tuesday Report

David Ermer–Congress, FDA, SDOH, U.S. Healthcare–

From Washington, DC

  • Per HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS) announced today that Secretary Robert F. Kennedy, Jr. renewed the public health emergency declaration addressing our nation’s opioid crisis, which will allow sustained federal coordination efforts and preserve key flexibilities that enable HHS to continue leveraging expanded authorities to conduct certain activities in response to the opioid overdose crisis.
    • “Although overdose deaths are starting to decline, opioid-involved overdoses remain the leading cause of drug-related fatalities,” HHS Secretary Kennedy said. “This Administration is going to treat this urgent crisis in American health as the national security emergency that it is. Renewing the Opioid Public Health Emergency Declaration affirms the Administration’s commitment to addressing the opioid overdose crisis and is one of many critical steps we will take to Make America Healthy Again.”
  • and
    • “Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration is taking steps to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.
    • “The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” said HHS Secretary Kennedy. “Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.”
    • “The FDA is announcing a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process and increasing testing for heavy metals and other contaminants. The agency is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. These enhanced FDA commitments are focused on making sure a strong supply of the sole source of nutrition for formula-fed babies and children remains available for one of our nation’s most vulnerable populations.”
  • STAT News reports,
    • “In a last-ditch effort to turn its fortunes around, Anson General [ located in Anson, a West-Central Texas town of roughly 2,300 people] applied to be a Rural Emergency Hospital, a new type of hospital Congress created in 2023 to keep rural hospitals afloat. The government pays these hospitals a fixed sum each month — over $3 million annually — instead of reimbursing them for the inpatient services they provide. Medicare also adds 5% to their payments for outpatient services. For Anson General, those monthly checks of roughly $270,000 have brought it back from the brink. 
    • “And yet, just 38 hospitals have taken up the new designation since 2023, fewer than researchers had predicted. Many of them are hospitals like Anson General, whose leaders felt they had no other choice. 
    • “It would seem to be a stopgap to the hospital closure crisis,” said Brock Slabach, chief operations officer of the National Rural Health Association. “In that sense, I think it’s fulfilling its mandate.” * * *
    • “Becoming a REH means giving up inpatient care. These hospitals still operate emergency rooms and treat patients on an observation basis, which can entail overnight stays, as well as provide outpatient care and operate labs.
    • “For most eligible hospitals, though, the cons outweigh the pros. The biggest downside, several hospital leaders said, is the fact that REHs can’t have swing beds. A swing bed is a hospital bed that can be used to provide both acute care and post-acute rehabilitation. They’re especially important in rural communities, which don’t always have nursing homes or rehabilitation facilities. In those areas, patients travel elsewhere for surgeries and return to swing beds in their local hospitals to recover and receive occupational or physical therapy. 
    • “U.S. Sens. Jerry Moran (R-Kan.), and Tina Smith, (D-Minn.), introduced a bill dubbed REH 2.0 that would make several tweaks to the designation, including allowing the hospitals to have swing beds, though it wouldn’t make them eligible for 340B discounts.” 
  • Reuters lets us know,
    •  The U.S. Food and Drug Administration (FDA) issued a warning on Friday, advising consumers against inhaling products containing nitrous oxide, commonly known as ‘laughing gas,’ due to potentially serious side effects, including death.
    • Nitrous oxide is an odorless, colorless gas that leads to euphoria, relaxation, and dissociation from reality when inhaled.” * * *
    • “It is available in compact, affordable cartridges that are easily accessible and sold under various brand names, including Galaxy Gas, Baking Bad, and Miami Magic.
    • “The FDA cautioned against the improper use of these products in any canister, tank, or charger size, as misuse could result in severe health issues, including blood clots, loss of consciousness, paralysis, psychiatric disorders, and even death.”

From the public health and medical research front,

  • Health Day tells us,
    • “Nearly 1 in 3 children live with a chronic condition that could significantly affect their health for the rest of their lives, a new study says.
    • “Chronic illnesses affected more than 30% of children ages 5 to 17 by 2018, up from around 23% in 1999, researchers report in the journal Academic Pediatrics.
    • “This adds up to about 130,000 more children each year being diagnosed with a chronic illness.
    • “This increase has been driven by diagnoses of ADHD/ADD, autism, asthma, prediabetes and mood disorders like depression or anxiety, lead researcher Lauren Wisk, an assistant professor of medicine at the David Geffen School of Medicine at UCLA, said in a news release.”
  • Health Leaders offers “Social Determinant of Health Considerations for CMOs.”
  • Healio relates,
    • “Women with chronic pelvic pain disorders who engaged in moderate to vigorous physical activity had improved mental health scores vs. those who did not, according to study results published in the Journal of Pain Research.
    • “Moderate to vigorous intensity physical activity could be a beneficial way for patients who have a chronic pelvic pain disorder to manage their overall mental health,” Ipek Ensari, PhD, assistant professor in the department of artificial intelligence and human health at the Icahn School of Medicine at Mount Sinai, told Healio. “This seems to be a consistent effect, because even after we adjusted for things like physical pain, physical function and pre-existing psychiatric diagnoses, we still saw this positive significant association between physical activity, behavior and their mental health and well-being at each week as we looked at the results.”
  • Sadly, BioPharma Dive reports,
    • A young man with Duchenne muscular dystrophy has died following treatment with Sarepta Therapeutics’ gene therapy Elevidys, the company said Tuesday.
    • In a short statement, Sarepta said the patient suffered acute liver failure after receiving Elevidys, the only approved gene therapy for the disease. Liver damage is a known risk of treatment with Elevidys as well as other gene therapies that are built around a type of modified virus. The death is the first reported among the more than 800 people in clinical testing and commercially who been treated with the therapy, however.
    • “According to Sarepta, testing showed the patient had a recent infection with cytomegalovirus, a common virus that for most people doesn’t cause symptoms but can lead to serious health issues in those with weakened immune systems. A treating physician cited the infection as a “possible contributing factor” to the death, as cytomegalovirus can infect and damage the liver, leading to hepatitis.
    • “The company reported the death to study investigators, physicians and health authorities. It plans to update Elevidys’ prescribing information to “appropriately represent the event.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “DispatchHealth Tuesday announced a definitive agreement to acquire Medically Home, which would create one of the nation’s largest providers of home-based healthcare services.
    • “The combined company would offer an array of home-based medical services, including urgent care, acute-level care and skilled nursing to patients in 50 metropolitan markets across 23 states and the District of Columbia, with approximately 2,200 employees.
    • “Neither company would disclose financial terms of the deal, which is expected to close by the middle of the year, pending regulatory approval.”
  • and
    • “Patina Health rolled out a new program Tuesday that will provide expanded home-based care to Medicare Advantage members.
    • “The Bala Cynwyd, Pennsylvania-based company said Patina Total Health will provide health assessments, medication management, primary care, urgent care and behavioral health services to older adults in their homes through in-person and telehealth visits. Patina Health is launching the new initiative later this week with a national insurer in Charlotte, North Carolina, the company said in a news release. The company did not disclose the name of the insurer but hopes to ultimately work with multiple Medicare Advantage plans.”
  • and
    • “GE HealthCare announced on Tuesday that it is partnering with Nvidia to work on autonomous X-ray and ultrasound scanners that will leverage artificial intelligence-enabled software to capture and analyze medical images.
    • “The company is developing the technology to help ease the burden of rising patient volumes and staff shortages on healthcare professionals, Roland Rott, president and CEO of imaging at GE HealthCare, said in a news release.”
  • Per Fierce Healthcare,
    • Food delivery and engagement company FarmboxRx will launch Drivers Health, a social determinants of health (SDOH) product line for health plans to better serve their members.
    • FarmboxRx combines food as medicine with health literacy to drive member behavioral change, most notably for members living in food deserts. Drivers Health, starting in June, will act as a care management intervention to connect members to underutilized benefits through food deliveries, founder and CEO Ashley Tyrner-Dolce said in an interview with Fierce Healthcare.
    • “We’ve always had health literacy in the box,” she said. “What Drivers Health is built around is connecting to that care … where we take on that care management piece for the health plan through our member contact center.”
    • “Drivers Health will be an additional product line offered to plans with Medicare, Medicaid and duals members. Many people make difficult financial decisions, having to choose between paying a bill, buying food or refilling a medication. Yet members often don’t realize the full scope of benefits available to them unless there is adequate outreach, said Tyrner-Dolce. These benefits can include transportation, utility or mail-order pharmacy perks.”

Monday Report

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Bloomberg Law reports,
    • “Mehmet Oz, President Donald Trump’s nominee to lead the Centers for Medicare & Medicaid Services, used his Senate confirmation hearing Friday to tout the benefits of artificial intelligence to help streamline the prior approval process for Medicare managed care plans.
    • “But consumer policy watchers were immediately leery, noting the string of recent legal challenges stemming from AI-influenced coverage denials by Medicare Advantage plans.
    • “We are very concerned that increasing the use of AI will only make the prior authorization situation worse,” Alice Bers, litigation director at the Center for Medicare Advocacy, said in a statement.” * * *
    • “Sen. Tina Smith (D-Minn.) expressed similar concerns about lawsuits against MA insurers alleging use of AI to determine length of hospital stays and to deny claims. “This is a big concern,” Smith told Oz. “My view is that a human needs to have a final say in these decisions.”
    • “Oz said he agreed with Smith about the need for humans to make final coverage decisions. But Oz maintained that he thinks “AI can play a vital role in accelerating pre-authorization.”
    • “He also said the CMS should be using AI to identify insurers that are misusing the technology.”
  • Beckers Hospital Review adds,
    • “CMS will not change the Biden administration’s plan to negotiate prices for 15 previously named prescription drugs, and the agency’s next potential leader says he will defend the program in court.
    • “In January, CMS selected Ozempic, Rybelsus, Wegovy, Trelegy Ellipta, Xtandi, Pomalyst, Ibrance, Ofev, Linzess, Calquence, Austedo, Breo Ellipta, Tradjenta, Xifaxan, Vraylar, Janumet, and Otezla to be included in the second round of negotiations aimed at reducing drug costs for Medicare beneficiaries. 
    • “On March 14, CMS said it had signed agreements with manufacturers, who will now participate in meetings and roundtables throughout 2025 to negotiate maximum fair prices for the 15 drugs, with final agreements due by Nov. 1.
    • “Mehmet Oz, MD, President Donald Trump’s pick for CMS administrator, told the Senate Finance Committee March 14 he would defend the negotiation program in court.
    • “It’s the law. I’m going to defend it and use it,” he said, adding that it is one of multiple approaches he would pursue to lower drug costs.
    • “The selected drugs account for approximately $41 billion in total spending under Medicare Part D between November 2023 and October 2024, or about 14% of Medicare Part D’s prescription drug costs, according to CMS. The negotiated prices for the drugs will take effect in 2027.”
  • HUB International tells us,
    • “Following on the enactment late last year of two bills to simplify employer reporting under the Affordable Care Act (“ACA”), the IRS has now released its first bit of guidance in the form of Notice 2025-15. The notice provides guidance on how employers can avoid providing individual Forms 1095-C to their employees. Perhaps unsurprisingly, it essentially piggybacks on existing guidance that applies to insurance carriers and other coverage providers.”
  • STAT News adds, “FTC highlights new concern over ‘pay-to-delay’ deals that determine when generics are sold. The agency noted restrictions on how many drugs a generic company may sell as part of a patent settlement.”
  • Per MedTech Dive,
    • “The Food and Drug Administration warned healthcare providers Friday about interruptions to the supply of hemodialysis bloodlines.
    • “The letter said the disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.
    • “The FDA linked to a letter B. Braun sent to customers in January. B. Braun said “additional supply and labor constraints over the holidays” had reduced production and it would run out of product on Jan. 20.”
  • Per Fierce Pharma,
    • “A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.
    • “The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls.” 

From the judicial front,

  • A panel of the U.S. Court of Appeals for the Ninth Circuit denied the Justice Department’s request for an immediate stay of the lower court’s decision to reinstate terminated probationary employees from six federal agencies. The panel set a briefing schedule on the Justice’s Department’s underlying motion to stay.
  • Bloomberg Law reports,
    • “Walmart Inc. is suing many of the nation’s largest pharmaceutical companies, alleging they colluded to inflate the price of hundreds of generic drugs and caused the retailer to pay more for the medications than it should have.
    • “Mylan Inc., Teva Pharmaceuticals USA Inc., and Glenmark Pharmaceuticals Inc. are among the defendant companies that exchanged drug price points and bid information as part of a conspiracy that specifically targeted Walmart, according to a nearly 700-page complaint filed Friday in the US District Court for the Eastern District of Pennsylvania.
    • “Walmart is one of the largest pharmacy providers in the US, purchasing hundreds of millions of dollars of prescription drugs every year. 
    • “The suit adds to similar cases against pharma companies brought by independent pharmacies, hospitals, and federal and state law enforcers.”
    • “The case is Walmart v. Actavis Elizabeth LLC, E.D. Pa., No. 2:25-cv-01383, 3/14/25″ 

From the public health and medical research front,

  • The Washington Post reports,
    • “By 2050, there will be an estimated 25.2 million people living with Parkinson’s disease worldwide, a 112 percent increase from 2021, according to a new study published in the journal BMJ.
    • “The World Health Organization estimated that 8.5 million people worldwide were living with Parkinson’s disease in 2019.
    • “Researchers used data from the 2021 Global Burden of Disease Study, pulling information from 195 countries and territories. They identified aging and population growth as the main contributors to the projected increase in Parkinson’s numbers, noting that growth rates would differ at regional and national levels.”
  • The American Medical Association lets us know what doctors wish their patients knew about pertussis.
  • MedPage Today tells us,
    • “A probiotic mixture reduced fever duration by 2 days versus placebo among children with upper respiratory tract infections.
    • “Probiotics have emerged as a new potential approach to managing infectious diseases.
    • “Adverse events were mild, and did not significantly differ between the two groups.
  • and fills us in on which adults need a measles booster in the U.S.
  • Beckers Hospital Review identifies the “10 most, least overweight and obese cities in the U.S.”
    • “McAllen, Texas, topped WalletHub’s 2025 ranking of the most overweight and obese cities in the U.S., published March 17, while Honolulu is the healthiest-weight city.”
  • Per a press release,
    • “The National Institute of Standards and Technology (NIST) has released a human stool reference material that will help scientists accurately measure the gut microbiome. The initiative aims to speed progress in a cutting-edge field of medical research targeting some of humanity’s most serious and intractable diseases.
    • “The human gut microbiome is a rich, teeming ecosystem of microorganisms and their byproducts that line the human gastrointestinal tract. Over the last decade, scientists have linked activity in the gut microbiome to obesity, diabetes, mental illness, cancer and other medical conditions. Researchers believe that a new class of drugs targeting the gut microbiome can treat many of these conditions.”
  • Per National Institutes of Health news releases,
    • “Surgical removal of enlarged tonsils and adenoids in children with mild sleep-disordered breathing (SDB) appears to significantly reduce the frequency of medical office visits and prescription medicine use in this group, according to a clinical study supported by the National Institutes of Health (NIH). The findings, published in JAMA Pediatrics, show that the surgery, called adenotonsillectomy, was tied to a 32% reduction in medical visits and a 48% reduction in prescription use among children with a mild form of the condition.”
  • and
    • In a preclinical study, rodents treated with uric acid showed improved long-term outcomes after acute ischemic stroke. The findings suggest that the treatment may work as an add-on therapy to standard stroke treatments in humans. The study was funded by the National Institutes of Health (NIH) and published in Stroke.
  • Consumer Reports, writing in the Washington Post, informs us about “Everything you need to know to keep your teeth healthy. Toothpaste matters, and you might want to consider adding a tongue scraper to your routine.”
  • Per BioPharma Dive,
    • “An experimental cellular medicine developed by Orca Bio outperformed a standard stem cell transplant in treating people with several types of blood cancer by helping avert a potentially dangerous side effect. 
    • “According to clinical trial results announced by Orca on Monday, about three-quarters of people treated with the company’s T cell immunotherapy did not experience moderate-to-severe chronic graft-versus-host disease through one year, compared to only 38% of those given the standard transplant. 
    • “Graft-versus-host disease, or GvHD, is a serious complication of transplants involving cells sourced from matched donors. Orca aims to develop its therapy, which uses a purified mix of donor-derived T cells and stem cells, as a safer transplant alternative in cancers like acute myeloid leukemia.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Median hospital margins remained stable to kick off 2025, as many reported higher service volumes and expenses.
    • “Kaufman Hall’s “National Hospital Flash Report” revealed January median operating margins hit 4.4%, up from 3.7% in December and 0.6% last January. Without allocations, the median operating margin grew to 8%, a 12-month high. the averages are based on data from more than 1,300 hospitals and gathered by Strata Decision Technology. 
    • “January was a relatively stable month for hospitals, as more people received care due in part to seasonal challenges like flu and other respiratory diseases. Hospitals are also experiencing more rapid revenue growth from inpatient than outpatient services. Expenses are also rising, driven primarily by drug costs, though the rate of cost growth has slowed,” said Erik Swanson, managing director and group leader, data and analytics, of Kaufman Hall.”
  • Fierce Healthcare notes,
    • “Highmark Health reported $29.4 billion in revenue and $50 million in net income for 2024 as the organization continues to weather notable headwinds that have battered health insurers.
    • “Highmark also posted $209 million in operating losses, according to its earnings report released last week. The full year results “reflect the negative operating performance of Highmark Health Plans,” the company said in a press release, as the team faced cost pressures throughout the year.
    • “United Concordia Dental and HM Insurance Group, the company’s stop-loss division, were bright spots with steady performance. Highmark said that trend was backed by growing dental membership and a disciplined pricing approach.
    • “Its health system, Allegheny Health Network, also saw improvements as patient volumes increased across “all delivery areas.”
    • “While our consolidated revenue improved, we continue to face significant industry headwinds and medical cost trends, including high costs for prescription drugs, especially GLP-1s, the impact of Medicaid redeterminations and nationwide high utilization, especially within the Medicare Advantage portfolio,” said Carl Daley, chief financial officer and treasurer of Highmark Health.” 
  • Fierce Pharma points out “the top 10 drugs losing US exclusivity in 2025.”
    • “While each year features high-profile losses of exclusivity in the pharma industry, this year’s list is something of a doozy.”
  • The Wall Street Journal reports,
    • “Pfizer PFE had a problem. Doctors weren’t prescribing its migraine drug Nurtec because they assumed insurance coverage would be too much of a hassle.
    • “So last year the company created a phone line for doctors and patients to call Pfizer directly for help. Pfizer now credits that and other changes for a 31% increase in Nurtec’s U.S. sales last year.
    • “The beleaguered drugmaker’s shares still haven’t recovered from their post-Covid slump, and shareholders are wary. But sales of products such as Nurtec and the vaccine Abrysvo that the company has been counting on are rising, and an activist shareholder’s push has lost steam. 
    • “Pfizer did it by shaking up its U.S. sales strategy, shifting where it deploys its sales representatives, how they market to doctors and how the company helps patients pay for their prescriptions.”
  • Per Modern Healthcare,
    • “Scripps Health plans to build a $1.2 billion medical campus that will include a 200- to 250-bed hospital and outpatient facilities.
    • “The San Diego-based health system’s board last week approved the 13-acre development in San Marcos, California. The first phase of the project will feature space for specialty and primary care offices, ambulatory surgery, cancer care, imaging, lab and other services, and the second phase includes the hospital, according to a Monday news release.
    • “The outpatient center will be built in two to three years, and the hospital will take about six years, a spokesperson estimated.”
  • and
    • “Sharon Regional Medical Center is set to reopen Tuesday, about two months after the former Steward Health Care facility in Pennsylvania closed.
    • “On Friday, the Pennsylvania Department of Health approved Pasadena, California-based Tenor Health Foundation’s plans to reopen the 163-bed hospital. In January, Judge Christopher Lopez of the U.S. Bankruptcy Court for the Southern District of Texas in Houston signed off on the hospital management company’s takeover of the facility, which employed more than 800 workers“
  • From BioPharma Dive,
    • “AstraZeneca is bolstering its cell therapy capabilities, agreeing on Monday to pay up to $1 billion for a biotechnology startup making treatments that reprogram cells inside the body.
    • “The British drugmaker is buying EsoBiotech, a Belgian startup, for $425 million in cash upfront. EsoBiotech’s investors, among them Invivo Partners and UCB Ventures, could receive up to $575 million in additional payouts should the startup’s programs hit certain development and regulatory milestones, AstraZeneca said in a statement.”