Tuesday Report

COVID-19

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Following up on yesterday’s post about the House budget reconciliation bill, Govexec informs us,
    • “According to the latest draft of the bill, published early Monday morning, Republicans have ditched the plan to effectively un-grandfather employees hired prior to 2014 into paying more of their paychecks toward their retirement benefits.
    • “On the FERS supplement, which can amount to one-third of a federal retiree’s income until they turn 62, lawmakers expanded an exemption for federal workers who are required to retire early, such as air traffic controllers and federal law enforcement personnel, to cover all such employees, regardless of whether they actually are forced out because they hit the mandatory retirement age. The implementation date, previously set on the date of the bill’s enactment, has been shifted to Jan. 1, 2028, and language now exists clarifying that federal employees may maintain eligibility for the supplement provided they are “entitled” to it prior to 2028.
    • “The latest draft also delays the change in federal retirees’ annuity calculations from the high-3 to high-5 average salary model by one year, to Jan. 1, 2028.”
  • KFF posted a summary of Medicaid provisions in the House budget reconciliation bill.
  • Roll Call reports,
    • “President Donald Trump urged the House GOP to stop negotiating and pass his “big, beautiful” filibuster-proof reconciliation bill Tuesday, with sharp words for blue-state Republicans pushing for more tax relief and conservatives seeking additional spending cuts.
    • “In an appearance during the weekly GOP conference meeting, Trump told conservatives to lay off Medicaid, scolded blue-state Republicans for rejecting a $30,000 cap on state and local tax deductions and urged the party to increase the country’s borrowing limit through the rest of his term, members leaving the meeting said. * * *
    • “Trump’s visit did little to move the needle in support of the bill, leaving leadership where they started the week: trying to strike a balance between steeper cuts needed to satisfy conservatives without alienating centrists, and finding space for more SALT relief.
    • “Republicans can afford to lose no more than three GOP votes and pass the partisan legislation.
    • “After the meeting, Speaker Mike Johnson said he was ready to convene the holdouts in smaller groups to try to reach a deal.”
  • Per a Congressional press release,
    • “Congressman Gerald E. Connolly (D-VA) and Congressman James Comer (R-KY), the Ranking Member and Chairman of the House Committee on Oversight and Government Reform respectively, introduced the Esophageal Cancer Awareness Act, bipartisan legislation to commission a Government Accountability Office (GAO) study on gaps in screening and prevention of esophageal cancer. 
    • “Esophageal Cancer is quickly on the rise, touching the lives of tens of thousands of Americans – including mine,” said Ranking Member Connolly. “It is vital that we all do our part to raise awareness and push for more research and more effective prevention efforts. I am immensely grateful to my colleague, Chairman Comer, for joining me in introducing this important legislation today. Together, we will fight to end esophageal cancer, bringing hope to thousands of American families.” * * *
    • “Text of the legislation is available here.”
  • The American Hospital Association News tells us,
    • Secretary of Health and Human Services Robert F. Kennedy Jr. May 20 appeared before the Senate Appropriations Committee for a hearing to testify on the discretionary budget proposal for fiscal year 2026.
      • Roll Call offers more details on the hearing.
  • and
    • “The Department of Health and Human Services May 20 announced it has identified specific pricing targets for pharmaceutical manufacturers to meet to satisfy requirements of the Trump administration’s executive order allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in an Organization for Economic Co-operation and Development country with a gross domestic product per capita that is at least 60% of the U.S. GDP per capita.”
      • Beckers Hospital Review calls attention to six things to know about this announcement.

From the Foord and Drug Administration front,

  • The Wall Street Journal points out,
    • “The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and children.
    • “Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects that it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too.”
  • MedPage Today notes,
    • The FDA warned that some people develop severe itching, or pruritus, after stopping long-term use of the antihistamines cetirizine (Zyrtec) or levocetirizine (Xyzal).
    • Prescribing information for the oral allergy drugs — which are taken daily and sold both in prescription and over-the-counter (OTC) forms — will be updated to warn about the post-discontinuation risk. The itching typically occurs within a few days of stopping the products.
    • “Restarting the medicine resolved pruritus in most individuals, and tapering off the medicine after restarting it resolved symptoms in some who tried this approach,” the FDA said in its safety communication.”
  • Fierce Pharma adds,
    • “Roche looks unlikely to be able to move its DLBCL drug Columvi earlier in the treatment sequence after experts in an FDA advisory committee joined the agency in questioning the regional imbalance of clinical trial data. What’s more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new message for drug developers.
    • “A panel of experts on the FDA’s Oncologic Drugs Advisory Committee voted 8 to 1 Tuesday that results from Roche’s phase 3 Starglo trial are not applicable to a U.S. patient population. The trial evaluated the combination of Columvi and the chemotherapy regimen GemOx in second- or later-line transplant-ineligible DLBCL. 
    • “A patient representative cast the only yes vote.”
  • MedTech Dive announced the creation of an online database that tracks FDA approval of medical devices that incorporate artificial intelligence.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Covid-19 virus in the U.S. has largely faded from view. But it hasn’t faded away. 
    • “National wastewater data shows low Covid-19 activity, according to the Centers for Disease Control and Prevention. The weekly reported Covid-19 deaths in April were slightly down compared with the same time a year earlier, federal data shows. Still, more than 300 Covid-19-related deaths were reported weekly as recently as mid-April. 
    • “Some infectious-disease specialists said they expect more cases this summer, as there have been somewhat regular summertime increases in the past. Others cautioned that Covid-19 can still surprise us, more than five years after it spurred a global pandemic that killed more than 1.2 million Americans. 
    • “It is at our lowest levels it has been since the beginning of the pandemic,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Our challenge is we don’t know what that means for tomorrow.” 
  • Per MedPage Today,
    • “The use of antibiotics in patients hospitalized with non-severe COVID-19 was not associated with better outcomes, a large retrospective cohort study found.
    • “Among more than half a million U.S. patients with COVID, those given antibiotics on their first day of hospitalization had a slightly higher rate of deterioration or death compared with those who didn’t receive antibiotics (20.8% vs 18.4%), reported researchers led by Michael Pulia, MD, PhD, of the University of Wisconsin-Madison.
    • “The difference didn’t meet criteria for being of clinical significance. However, a propensity-matched analysis did show a significantly higher odds of poor clinical outcomes for those who received antibiotics (OR 1.03, 95% CI 1.01-1.05, P=0.003), according to findings published in JAMA Network Open.
    • “Hopefully, studies like this raise the bar for antibiotic initiation in patients with confirmed COVID-19, even if they are sick enough to require hospital admission,” Pulia told MedPage Today.
    • “Pulia noted that there’s often a lot of uncertainty as to whether a patient hospitalized with COVID also has a bacterial infection, so physicians may prescribe antibiotics to be safe. “Hopefully, studies like this will reduce this uncertainty and improve judicious antibiotic use, thus helping in the fight against antibiotic resistance,” he said.”
  • The New York Times discusses “A New System Aims to Save Injured Brains and Lives. Nearly 100 neurology experts collaborated on the creation of a new method of evaluating patients with traumatic brain injuries.”
  • The latest National Institutes of Health’s (NIH) Research Matters covers “Cancer trends in younger people | Measuring biological age | Brain rewiring in motor learning.”
  • Per a NIH news release,
    • For the first time, researchers at the National Institutes of Health (NIH) identified patterns of metabolites in blood and urine that can be used as an objective measure of an individual’s consumption of energy from ultra-processed foods. Metabolites are left after the body converts food into energy, a process known as metabolism. Scientists used these data to develop a score based on multiple metabolites, known as a poly-metabolite score, that has the potential to reduce the reliance on, or complement the use of, self-reported dietary data in large population studies. The findings appeared May 20, 2025, in PLOS Medicine.   
    • “Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said lead investigator Erikka Loftfield, Ph.D., M.P.H., of NIH’s National Cancer Institute.”
  • MedPage points out,
    • “Dementia incidence fell among Medicare beneficiaries from 2015 to 2021, but prevalence rose.
    • “Incidence was higher for Black beneficiaries than any other racial or ethnic group.
    • “Those living in socioeconomically deprived neighborhoods had the highest incidence and prevalence.”
  • FYI, “Prevalence differs from incidence in that prevalence includes all cases, both new and preexisting, in the population at the specified time, whereas incidence is limited to new cases only.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
  • STAT News lets us know,
    • “Developers of digital mental health treatments now have fresh economic data to help make the case for broader coverage of their apps.
    • “Companies selling Food and Drug Administration-cleared apps for the treatment of psychiatric and other conditions have long struggled with adoption by patients, providers, and payers for many reasons. Clinical evidence supporting these prescription digital therapeutics has gradually improved, but policymakers and insurers have been hesitant to open the path to reimbursement too quickly.” * * *
    • “In a new report, the Peterson Health Technology Institute (PHTI) finds that Rejoyn, an app for depression from Otsuka Precision Health, and DaylightRx, an app for anxiety from Big Health, warrant further adoption because their clinical trials show strong evidence of benefits. Both apps are intended to be used alongside ongoing mental health treatment, and in most cases, the institute found the apps will save money.” * * *
    • “Elsewhere, advocates from the American Telemedicine Association’s advocacy arm, ATA Action, are preparing to brief lawmakers about data showing that Germany’s broad expansion of coverage for digital apps resulted in 234 million euros in spending from 2020 to 2024. The report, produced by Germany’s National Association of Statutory Health Insurance Funds, also found 861,000 total app activations. That’s a cost of about 271 euros per use.”
  • Fierce Healthcare adds,
    • “Employers are continuing to invest in their well-being programs, but they will be raising the bar for what’s expected from their vendors.
    • “The Business Group on Health released a survey looking at employer strategies around well-being initiatives, polling 131 firms that employ 11.2 million people collectively. The employers represent multiple sizes and geographies, with 60% being multinational.
    • “The survey found that 93% of employers intend to either maintain or expand their well-being programs for 2025. Most (73%) said they will keep their existing offerings, while 20% said they will grow.
    • “In tandem, 94% of those surveyed said they will be increasing the expectations they have for well-being program vendors to show improvements to outcomes. Jim Winkler, chief strategy officer for the Business Group, said during a media briefing that this isn’t a new trend but that employers are simply turning up the heat on these vendors.”
  • Per Institutes for Clinical and Economic Review news releases,
    • The Institute for Clinical and Economic Review (ICER) posted a Protocol today [May 19] outlining how it will conduct a new annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies.”
  • and
    • The Institute for Clinical and Economic Review (ICER) announced today [May 20] that it will assess the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences) for smoking cessation [which is the first new smoking cessation drug for many years].
    • The assessment will be publicly discussed during a meeting of the Midwest CEPAC in January 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment. 
  • Reuters reports,
    • “Online weight-loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk’s (NOVOb.CO) Wegovy as the U.S. drugs regulator clamps down on mass production of copies of the in-demand medicine.
    • “Noom will offer its version of compounded semaglutide – the active ingredient in Wegovy and diabetes drug Ozempic – as part of a program personalized for patients, which it says will comply with changing U.S. Food and Drug Administration regulations.”
  • Beckers Payer Issues informs us,
    • “CVS Health has named Creagh Milford, DO, as president of Oak Street Health.
    • “Dr. Milford has been with CVS since 2021, most recently serving as president of retail health. 
    • “I’m excited to start a new chapter at CVS Health as President of Oak Street Health, where I have the honor of developing and executing business strategy to further grow the organization,” he wrote on Linkedin on May 19. “As a practicing physician, I am passionate about providing consumer-centric primary care to patients — and Oak Street Health shares that passion, resulting in better experiences and outcomes for the older adults we serve.”

Weekend Update

David Ermer–Congress, COVID-19 vaccine, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC

  • The House Budget Committee will resume consideration of the budget reconciliation bill tonight at 10 pm ET.
  • The New York Times reports that “The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid.”

From the public health and medical research front,

  • The New York Times further reports,
    • “Surgeons in Southern California have performed the first human bladder transplant, introducing a new, potentially life-changing procedure for people with debilitating bladder conditions.
    • “The operation was performed earlier this month by a pair of surgeons from the University of California, Los Angeles, and the University of Southern California on a 41-year-old man who had lost much of his bladder capacity from treatments for a rare form of bladder cancer.
    • “I was a ticking time bomb,” the patient, Oscar Larrainzar, said on Thursday during a follow-up appointment with his doctors. “But now I have hope.”
    • “The doctors plan to perform bladder transplants in four more patients as part of a clinical trial to get a sense of outcomes like bladder capacity and graft complications before pursuing a larger trial to expand its use.”
  • and
    • “Kristin Kramer woke up early on a Tuesday morning 10 years ago because one of her dogs needed to go out. Then, a couple of odd things happened.
    • “When she tried to call her other dog, “I couldn’t speak,” she said. As she walked downstairs to let them into the yard, “I noticed that my right hand wasn’t working.”
    • “But she went back to bed, “which was totally stupid,” said Ms. Kramer, now 54, an office manager in Muncie, Ind. “It didn’t register that something major was happening,” especially because, reawakening an hour later, “I was perfectly fine.”
    • “So she “just kind of blew it off” and went to work.
    • “It’s a common response to the neurological symptoms that signal a T.I.A., a transient ischemic attack or ministroke. At least 240,000 Americans experience one each year, with the incidence increasing sharply with age.” * * *
    • “Now, a large epidemiological study by researchers at the University of Alabama at Birmingham, published in JAMA Neurology, points to another reason to take T.I.A.s seriously: Over five years, study participants’ performance on cognitive tests after a T.I.A. drops as steeply as it does among victims of a full-on stroke.” * * *
    • “An accompanying editorial by Dr. Eric Smith, a neurologist at the University of Calgary, was pointedly headlined “Transient Ischemic Attack — Not So Transient After All!”
  • Medscape adds,
    • Is it time for universal screening for atrial fibrillation (AF), the most commonly treated type of arrhythmia that sets people up for strokes?
    • The question is important. While estimates of prevalence vary, a recent study found AF affects about 4% of the adult population or about 10 million in the United States. More than 795,000 people in the United States have a strokeeach year, and AF is blamed for 1 in 7.
    • For now, however, US organizations that issue guidelines and many leading cardiologists agree: It’s not yet warranted and may result in anticoagulation overtreatment, along with what they call the “nontrivial” risk for bleeding from that treatment.
    • However, it’s definitely a stay tuned situation, as researchers continue to investigate whether widespread screening can reduce the number of strokes in the broad population, others look at the role of “smart” technology, and still others focus on subsets of the population that might benefit most from routine screening.
  • The Washington Post points out,
    • “Eating an unhealthy diet is tied to an earlier first period, a new analysis suggests.
    • “The study linked a girl’s first menstrual period — a milestone known as menarche — to what she ate, showing ties between potentially inflammatory diets rich in processed and refined foods, red meat and beverages such as soda and an earlier onset of menstruation.
    • “Published in Human Reproduction, the study looked at 7,530 participants in the Growing Up Today Study, an ongoing study that evaluates factors thought to influence health across a lifetime. Participants enrolled in 1996 and 2004 and answered questionnaires about diet and activity, general health, family history, demographic factors and when they got their first period.
    • “Researchers assessed participants’ diets using two rubrics: the Alternative Healthy Eating Index, a score based on participants’ adherence to a healthy diet, and the Empirical Dietary Inflammatory Pattern, which identifies diets linked to inflammation. These potentially inflammatory diets are higher in processed foods, beverages like soda and juice, and red meat.
    • “Ninety-three percent of participants started their period during the study, at a median age of 13.1 years. But the age of menarche varied among participants with different diets. Overall, having a healthier diet predicted later menarche, and those who ate the healthiest diet were 8 percent less likely to get their first period in the next month. The association remained after researchers adjusted for body mass index, height and neighborhood socioeconomic status.”

From the U.S. healthcare business front,

  • The Wall Street Journal let us know,
    • “A government crackdown on cheaper copies of Ozempic and similar diabetes and weight-loss drugs was intended to shut the door on that booming market.
    • “It hasn’t exactly worked out that way. 
    • “Instead, some compounding pharmacies and telehealth companies that make the copies have found new ways in. They are making and selling dosages slightly different from the standard, FDA-approved amounts or including additives such as vitamins B3 and B12. Others have changed how the drug is taken, switching from injectables to under the tongue drops or pills.
    • “These providers are relying on a law that allows bespoke versions of drugs that are unavailable commercially. Though some patients report delays in receiving the compounded medications, many are still getting them—at least for now—said patients and industry professionals. 
  • MedTech Dive tells us,
    • “Siemens Healthineers said Wednesday it is investing $150 million to expand production in the U.S.
    • “Siemens is relocating manufacturing operations for its radiation oncology business Varian from Mexico to the U.S. The company said the change will add around 50 jobs in California.
    • “The company is also building a 60,000 square foot “Experience Center” in North Carolina, investing $141 million in a research and innovation district that it has been involved with since 2023.”

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican spending hawks blocked the party’s giant tax-and-spending bill on Friday, delivering President Trump a setback over disagreements on Medicaid, clean-energy tax breaks and budget deficits.
    • “The holdouts—Reps. Chip Roy of Texas, Ralph Norman of South Carolina, Josh Brecheen of Oklahoma and Andrew Clyde of Georgia—stopped the Budget Committee from advancing the legislation, which leaders hope to pass by the full House next week. The panel failed to move the bill on a 16-21 vote, with those four Republicans and Rep. Lloyd Smucker (R., Pa.) joining all Democrats in opposition. Smucker, who backs the measure, said he voted no for procedural reasons, so he can call for a revote later.
    • “Budget Committee Chairman Jodey Arrington (R., Texas) said lawmakers were close to agreements on making changes to win the necessary votes. The committee scheduled its session to resume at 10 p.m. Sunday.”
  • and
    • “The U.S. lost its last triple-A credit rating.
    • “Moody’s Ratings downgraded the U.S. government on Friday, citing large fiscal deficits and rising interest costs.
    • “Runaway budget deficits mean U.S. government borrowing will balloon at an accelerating rate, pushing interest rates up over the long term, Moody’s said. The firm said in a March report that fiscal weakness looked set to continue even under analysts’ best-case scenarios.”
  • Modern Healthcare adds,
    • “Long-sought legislation to monitor and restrict how pharmacy benefit mangers operate could finally pass — if Republicans can move their sweeping budget bill that includes a string of those provisions.
    • ‘New PBM measures are tucked into the bill advanced Wednesday by the House Energy and Commerce Committee, which aims to cut more than $880 billion in spending, including $625 billion from Medicaid. The restrictions have long been championed by Health Subcommittee Chair Buddy Carter (R-Ga.), who was a pharmacist before becoming a congressman.”
  • Per Govexec
    • “The Trump administration is abiding by a court order to pause layoffs across most federal agencies, but it is still finding ways to shrink the federal workforce through involuntary means. 
    • “The Housing and Urban Development Department has begun once again firing its probationary employees—those recently hired or promoted—through a process distinct and separate from a reduction in force. Other agencies, including the Labor Department and National Science Foundation, meanwhile, are walking back recent RIFs due to a court-issued temporary restraining order. 
    • “That order specifically prevented agencies from issuing layoffs or taking any action to implement their Agency RIF and Reorganization Plans, which were mandated by the Office of Management and Budget and the Office of Personnel Management earlier this year. Agencies that were on the cusp of implementing RIFs, such as the Interior Department, have put those plans on ice at least until the restraining order is set to expire after May 23.”
  • FedWeek called our attention to this OPM benefits administration letter about “Family Member Eligibility Verification Updates and Enrollment Processing.”
  • Fierce Pharma informs us,
    • “On the heels of a production-tinged executive order earlier this month, the Trump administration is doubling down on efforts to boost medicine manufacturing in the U.S.
    • “In a new public-private partnership spearheaded by the administration, the Department of Health and Human Services’ (HHS’) Administration for Strategic Preparedness and Response (ASPR) and the Defense Advanced Research Projects Agency (DARPA) are linking up with several universities and companies in a bid to improve manufacturing for essential medicines using technologies such as artificial intelligence, machine learning and informatics.
    • “The project, dubbed Equip-A-Pharma, will allow the federal agencies to work directly with Battelle Memorial Institute and Aprecia, Bright Path Laboratories, Rutgers University and Mark Cuban’s Cost Plus Drugs as the partners strive to boost domestic manufacturing of eight drugs and their active pharmaceutical ingredients, the ASPR said in a Thursday press release.”
  • STAT News reports,
    • “Optum, the health data and care provider division of UnitedHealth Group, is developing a way to calculate how sick Medicare patients are through artificial intelligence, instead of relying solely on diagnosis codes submitted by physicians.
    • “Ken Cohen, a physician and Optum’s executive director of translational research, said Thursday at a conference organized by America’s Physician Groups that he was working with the Duke-Margolis Institute for Health Policy on this “next generation” of Medicare risk coding using AI.”

From the FDA front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.
    • “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
  • STAT News adds,
    • “Jason Karlawish, a professor of medicine at the University of Pennsylvania who specializes in Alzheimer’s research, said that “used right, this is a test that could really help to improve the diagnostic experience.”
    • “But with the availability of easier-to-use tests, there’s always the risk of “some frisky prescribing habits,” Karlawish said. Particularly in the field of Alzheimer’s, where just a small number of doctors are trained to treat the increasingly common condition, “the outcome can be inappropriate prescribing of the tests because a lot of people have a desire to get it, but not a lot of clinicians know how to properly use it.”
    • “The test should only be used to help diagnose people who have confirmed cognitive impairment, and there’s a risk some doctors may skip the step of confirming, as it’s “much easier to order a test than it is to talk to a patient,” Karlawish said. 
    • “Still, “in the history of Alzheimer’s disease, this is a big day,” he said. “The notion 10 years ago that there’d be a blood test that detects the pathologies of Alzheimer’s was a bit of a science fiction fantasy kind of story, and now here it is FDA-approved and ready for clinical practice.”
  • Reuters points out,
    • “The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals’ (AMRX.O), opens new tab self-administered migraine drug, giving way to a quick and more convenient treatment option for patients.
    • “The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday.”

From the judicial front,

  • The American Hospital Association News informs us,
    • “A U.S. district court judge for the District of Columbia May 15 ruled the Department of Health and Human Services must preapprove the use of 340B “rebate models” before they can be implemented, which the department has not yet done for any of the models pursued by the plaintiff drug companies. 
    • “Judge Dabney Friedrich issued the ruling in a case brought by a number of drug companies, finding that when the statute says that in implementing price reductions, “any rebate or discount” taken into account shall be “as provided by the Secretary,” it means that HHS has the authority to approve or reject the proposed rebate models. “Put another way, the statute contemplates that the Secretary may ‘have as a condition’ or ‘stipulate’ how any rebate or discount is accounted for in the price ultimately paid by covered entities.” * * *
    • “HHS recently announced that it will be “in a position to provide guidance” about the drug industry’s proposed use of “rebate models” by the end of May.”

From the public health and medical research front.

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low and declining.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The University of Minnesota CIDRAP notes,
    • “The US measles picture grew by 23 cases this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “A total of 1,024 confirmed measle cases have been reported from 31 jurisdictions, with 14 outbreaks (defined as 3 or more related cases). Ninety-two percent of confirmed cases are outbreak-associated.
    • “Of the cases, 96% have occurred in people who are either unvaccinated or have unknown vaccination status, and 128 (13%) of case-patients have been hospitalized, including 69 children under the age of 5. Three deaths have been confirmed to date, including two in unvaccinated school-aged children.” * * *
    • “The CDC notes on its measles outbreak page that one the reasons for more measles activity is because MMR coverage among kindergartners is now below 95%—the level needed to maintain elimination status. Two doses of the MMR vaccine are 97% effective at preventing measles, and one dose is about 93% effective.”
  • The American Journal of Managed Care lets us know,
    • “Higher dietary inflammatory index (DII) scores are significantly associated with an increased risk of Alzheimer disease–related death among American adults, according to a study published in Experimental Gerontology.
    • “Although the exact mechanisms of Alzheimer disease remain unknown, accumulating evidence suggests that chronic inflammation plays a key role in its pathogenesis and progression. In particular, past research shows that neuroinflammation accelerates neuronal damage, synaptic loss, and cognitive decline observed in patients with Alzheimer disease.
    • “Anti-inflammatory diets can alleviate neuroinflammation in patients with Alzheimer disease by reducing systemic inflammation through several immune pathways in the brain and indirectly through the gut microbiome and body circulation pathways. Therefore, the researchers emphasized that an anti-inflammatory diet may constitute a beneficial nutritional approach in Alzheimer disease management.”
  • The Wall Street Journal reports
    • “Electricity is gaining traction as a potential treatment for diseases like cancer and rheumatoid arthritis.
    • “Companies like Novocure and SetPoint Medical are developing devices that use electricity to treat diseases.
    • “Clinical trials show promise, with devices extending survival for some cancer patients and improving arthritis symptoms.”
  • STAT News adds,
    • “Leading oncologists said this week that artificial intelligence will one day be as integrated into cancer care as it is in smartphones and self-driving cars — and that this is a change we should welcome.
    • “Their comments, made at STAT’s Breakthrough Summit West on Wednesday, reflected an optimistic view for how the health care system can use AI across nearly all aspects of cancer care, from matching patients with clinical trials to predicting how they might fare on a given treatment. Some of this work is already happening. The panelists noted that AI has the potential to offer deep expertise across a growing number of precisely defined cancer indications, and that the technology can generate insights research focused on individual hypotheses might miss.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Cleveland Clinic reported an operating income of $52.8 million (1.3% margin) in the first quarter, up slightly from $50.2 million (1.3% margin) in the same period last year, according to financial documents published May 16.”
  • and
    • “Phoenix-based Banner Health reported an operating income of $142.4 million (3.6% margin) in the first quarter, up from an $89.3 million operating gain (2.4% margin) in the first quarter of 2024, according to financial documents published May 15.”
  • Healthcare Dive reports,
    • “Rite Aid is selling more than 1,000 pharmacies to rival drugstore operators as the beleaguered “pharmacy chain limps through bankruptcy processes for a second time.
    • Rite Aid said it was formally pursuing sales of “substantially all of its assets” earlier this month. Now, healthcare companies CVS Health and Walgreens, along with grocery stores Albertsons, Kroger and Giant Eagle, are among the buyers snapping up Rite Aid stores, the company said on Thursday.
    • “CVS is one of the biggest buyers, agreeing to acquire prescription files from 625 Rite Aid locations in 15 states in areas where it already has a presence, along with fully buying and operating 64 stores in Idaho, Oregon and Washington. The sales are subject to approval by a New Jersey bankruptcy court, which is scheduled to hold a hearing on May 21 regarding the transactions.”
  • Fierce Healthcare tells us,
    • “More than 6 in 10 survey respondents say they expect their healthcare organizations to see higher revenue from value-based care arrangements this year than in 2024, according to a joint report from the National Association of Accountable ACOs and health tech company Innovaccer.
    • “The report surveyed 168 executive and clinical leaders at health systems, accountable care organizations, specialty providers, federally qualified health centers and other delivery organizations.
    • “The findings indicate a growing reliance on VBC programs for some organizations. A significant segment, 30%, of organizations said a quarter of their revenue is tied to VBC contracts. More than 20% indicated at least half of their revenue is derived from fully capitated or downside risk contracts.
    • “Three-fourths of respondents believe further financial support would propel VBC adoption more.”
  • The Wall Street Journal reports,
    • “Novo Nordisk CEO Lars Fruergaard Jorgensen is stepping down after eight years in the role.
    • “The move follows market challenges, a share-price decline, and pressure from its controlling foundation.
    • “Former CEO Lars Rebien Sorensen will join the board amid concerns about losing ground to Eli Lilly.”

Thursday Report

David Ermer–AHRQ, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Healthcare Dive summarizes the healthcare-related provisions of the various House committee budget reconciliation recommendations that the House Budget Committee will take up tomorrow.
  • As promised, the Departments of Health and Human Services, Labor, and the Treasury released today a non-enforcement policy concerning the 2024 mental health parity amendments.
    • “The Departments have requested that the ERIC litigation be held in abeyance while the Departments reconsider the 2024 [Mental Health Parity] Final Rule, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation through notice and comment rulemaking.
    • The Departments will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months. This enforcement relief applies only with respect to those portions of the 2024 Final Rule that are new in relation to the 2013 final rule. The Departments note that MHPAEA’s statutory obligations, as amended by the CAA, 2021, continue to have effect. 
  • The Wall Street Journal reports,
    • “The Trump administration is planning to drop recommendations that pregnant women, teenagers and children get Covid-19 vaccines as a matter of routine, according to people familiar with the matter.
    • “The Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., is expected to remove the Centers for Disease Control and Prevention’s recommendations for those groups around the same time it launches a new framework for approving vaccines, the people said.
    • “The exact timing of the announcement wasn’t clear, the people said, though it was expected in the coming days.”
  • Tammy Flanagan, writing in Govexec, discusses “Getting ready to retire. What you should do and how you should approach your retirement and health benefits planning before leaving federal service.”

From the FDA front,

  • Per an HHS press release,
    • “The U.S. Food and Drug Administration today is taking a major step to increase transparency and ensure the safety of chemicals in our food. The agency is launching a stronger, more systematic review process for food chemicals already on the market—especially those that concern consumers most.
    • “No parent should ever worry about what’s in their child’s food,” said HHS Secretary Robert F. Kennedy, Jr. “We’re taking decisive action and using every authority we have to clean up the food supply and protect American families.”
    • “Under the leadership of Secretary Kennedy and FDA Commissioner Martin A. Makary, M.D., M.P.H., the FDA will roll out several key actions over the coming months:
      • “A modernized, evidence-based prioritization scheme for reviewing existing chemicals. A draft will be released for public comment soon.
      • “A final, systematic post-market review process shaped by stakeholder input.
      • “An updated list of chemicals under review, including BHT, BHA, and ADA. The FDA will also take steps to expedite its review of chemicals currently under review like phthalates, propylparaben, and titanium dioxide. FDA will continue to share information about the status of this work on its public website as part the agency’s push for greater transparency.”
  • Fierce Pharma adds,
    • “Six years after Merck bought out Peloton Therapeutics, the New Jersey drugmaker is not remaining stationary with the crown jewel of the deal.
    • “On Wednesday, the FDA approved a third indication for Welireg (belzutifan), signing off on the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor to treat patients with rare pheochromocytoma or paraganglioma (PPGL) tumors in the endocrine system.
    • “The approval covers patients 12 and older with locally advanced, unresectable or metastatic PPGL and makes Welireg the first oral treatment for advanced PPGL, per Merck.”
  • Per MedPage Today,
    • The FDA granted a first-ever approval for a first-line therapy for anal cancer to the PD-1 inhibitor retifanlimab (Zynyz), the agency announced Thursday.
    • The approval stipulates use in combination with carboplatin and paclitaxel in newly diagnosed locally advanced/metastatic squamous cell carcinoma of the anal canal (SCAC) or as monotherapy for patients whose disease progressed on platinum-based chemotherapy.
    • “Patients with inoperable, locally recurrent, or metastatic anal cancer have historically faced poor 5-year survival rates and limited treatment options,” said Marwan Fakih, MD, of City of Hope in Duarte, California, in a statement from drugmaker Incyte. “This approval marks an important advancement as it makes a new treatment approach available for this challenging disease.”

From the public health and medical research front,

  • The Wall Street Journal tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. has made combating chronic diseasea rallying cry as he looks to overhaul the health department and “Make America Healthy Again.”
    • “So how healthy is America, historically? It isn’t that we used to be healthier, data show, but the biggest threats have changed.
    • “The deadliest scourges in the U.S. were once infectious, with influenza and tuberculosis topping the list at the start of the 20th century. Better sanitation and advances in antibiotics and vaccines muzzled them, transforming Americans’ well-being. Medical innovations and antismoking campaigns then spurred decades of progress against heart disease and cancer.
    • “But chronic diseases, persistent or long-lasting health conditions, are undermining that momentum, contributing to our stalled life expectancy over the past decade that trails behind that of other wealthy nations.
    • “Much of the gap in life expectancy is due to deaths among working-age adults, says Dr. Steven Woolf, a life-expectancy researcher at the Virginia Commonwealth University.
    • “Americans die earlier and are sicker than people in other high-income countries,” he said. “This has been true for a long time, and the trend is getting worse.”
  • Health Day informs us,
    • “More U.S. teenagers are getting weight-loss surgery, despite the discovery of new drugs like Ozempic/Wegovy that help people drop pounds surgery-free, a new study says.
    • “Weight loss surgeries for teens increased 15% between 2021 and 2023, researchers reported earlier this month in The Journal of Pediatrics.
    • “Further, much of the increase in weight-loss surgery is due to its increased popularity among Hispanic and Black teenagers, groups disproportionately affected by severe obesity compared to white teens, researchers said.
    • “The number of U.S. adolescents having access to this treatment that we know is safe and effective is the highest it’s ever been, and hopefully it’s the start of a positive weight loss journey that will get them to better health,” lead researcher Sarah Messiah, director of the Child and Adolescent Population Health Program at UT Southwestern Medical Center, said in a news release.”
  • Per Beckers Hospital Review,
    • “Adult patients taking Wegovy saw a reduced risk of experiencing a major adverse cardiovascular event within the first three months of treatment, according to a secondary analysis of the drug’s clinical trial data, presented May 12 at the European Congress on Obesity.”
  • Very good news from an NIH news release,
    • “A research team supported by the National Institutes of Health (NIH) has developed and safely delivered a personalized gene editing therapy to treat an infant with a life-threatening, incurable genetic disease. The infant, who was diagnosed with the rare condition carbamoyl phosphate synthetase 1 (CPS1) deficiency shortly after birth, has responded positively to the treatment. The process, from diagnosis to treatment, took only six months and marks the first time the technology has been successfully deployed to treat a human patient. The technology used in this study was developed using a platform that could be tweaked to treat a wide range of genetic disorders and opens the possibility of creating personalized treatments in other parts of the body.
    • “A team of researchers at the Children’s Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania (Penn) developed the customized therapy using the gene-editing platform CRISPR. They corrected a specific gene mutation in the baby’s liver cells that led to the disorder. CRISPR is an advanced gene editing technology that enables precise changes to DNA inside living cells. This is the first known case of a personalized CRISPR-based medicine administered to a single patient and was carefully designed to target non-reproductive cells so changes would only affect the patient.
    • “As a platform, gene editing — built on reusable components and rapid customization — promises a new era of precision medicine for hundreds of rare diseases, bringing life-changing therapies to patients when timing matters most: Early, fast, and tailored to the individual,” said Joni L. Rutter, Ph.D., director of NIH’s National Center for Advancing Translational Sciences (NCATS).”
  • BioPharma Dive adds,
    • “We are still in very early days,” said Rebecca Ahrens-Nicklas, an assistant professor of pediatrics at the University of Pennsylvania and study author. Doctors will monitor KJ’s progress and are considering other ways to evaluate the therapy’s effects without a biopsy.
    • “Yet the findings could carry important implications for drug research. There are more than 7,000 rare diseases, many of which are so uncommon they’re unlikely to be profitable for any companies that develop treatments for them. Gene editing could be a powerful solution, but an expensive development path and slim sales prospects make such medicines tough investment propositions. A large number of biotechnology firms pursuing gene editing are struggling to survive.” 
  • Here is a link to the All of Us Research Project’s Medical Minutes.
  • Per MedPage Today,
    • “First-line treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) significantly improved survival compared with lenvatinib (Lenvima) or sorafenib (Nexavar) for patients with unresectable hepatocellular carcinoma (HCC), the randomized phase III CheckMate 9DW trial showed.
    • “Of more than 600 patients, median overall survival (OS) was 23.7 months with the PD-1 inhibitor and CTLA-4 inhibitor combination versus 20.6 months with single-agent tyrosine kinase inhibitors (HR 0.79, 95% CI 0.65-0.96, P=0.018), reported Peter R. Galle, MD, of the University Medical Center in Mainz, Germany, and colleagues.
    • “Respective OS rates were 49% versus 39% at 24 months and 38% versus 24% at 36 months, they wrote in The Lancet.
    • “The overall survival rates “are the longest and highest reported for the approved systemic treatments in this setting,” wrote Galle and colleagues, adding that the results “support nivolumab plus ipilimumab as a first-line treatment” in unresectable HCC.
    • “Results of this trial led to the recent FDA approval of the combination as first-line treatment for adults with unresectable or metastatic HCC.”
  • Per Fierce Pharma,
    • “Merck’s Keytruda, with more than 40 approved indications, hasn’t yet been able to crack specifically into ovarian cancer. But with promising early results from a phase 3 study in certain patients, the checkpoint inhibitor may have found its place.
    • “At a pre-specified interim analysis of Merck’s phase 3 Keynote-B96 trial, which is testing Keytruda plus chemotherapy with or without Roche’s Avastin in patients with platinum-resistant recurrent ovarian cancer, the drug showed “statistically significant and clinically meaningful” improvements in progression-free survival regardless of patients’ PD-L1 status, Merck reported on Thursday.
    • “The trial compared the Keytruda regimen against placebo and chemotherapy, again with or without Avastin.”
  • HHS’s AHRQ released a systematic review finding
    • “No completed studies show if blood-based, multicancer screening tests help people compared with no screening or standard single-cancer screenings. We do not know if these tests save lives, reduce advanced cancers, or improve quality of life.
    • “We found 20 studies covering 109,177 people that tested how accurate 19 different multicancer screening tests were. Thirteen of these studies had serious flaws in how they were conducted.
    • “Accuracy varied widely based on:
      • “What the tests measured and how researchers analyzed it,
      • “How many and which types of cancers researchers tried to find,
      • “Which types of people were tested, and
      • “How the studies were designed.
    • “We graded the strength of evidence for accuracy as insufficient, meaning we cannot draw firm conclusions.
    • “We only found one study reporting on potential harms from multicancer screening tests. We graded the strength of evidence as insufficient for harms based on this single study.
    • “Studies that will be completed in the next 2 to 4 years may give more information about whether multicancer screening tests work and whether they have harms.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Higher patient volumes were not enough to keep CommonSpirit Health in the black during its latest quarter.
    • “Patient volumes soared across the country over the past couple of years due to a rebound in demand after the COVID-19 pandemic and overall population growth in fast-growing markets.
    • “The trend largely boosted net patient revenue and helped pad bottom lines for many health systems. Volume growth is one part of CommonSpirit’s strategy to improve operating performance.
    • “However, this year may bring a more complicated dynamic, given continued inflation, tariffs and federal funding uncertainty weighing on hospital finances.
    • “Chicago-based CommonSpirit recorded a $42 million net loss in its third quarter, compared with $282 million in net income a year ago, according to financial documents published Thursday. Results are not adjusted for the California provider fee program, which would add supplemental payments if approved by the Centers for Medicare and Medicaid Services.
    • “CommonSpirit said its financial results were impacted by expenses increasing at a faster rate than revenue, despite strong volumes, lower lengths of stay and higher productivity levels.”
  • Beckers Hospital Review lets us know,
    • “Texas Rural Hospital in Cleveland is set to reopen within the next week after it abruptly closed its doors the week of May 12 due to funding shortages, KIAH reported May 15. 
    • “The hospital’s lease agreement with Cleveland-based Emergency Hospital Systems, a community emergency hospital system, ended in March 2025. It then gained new ownership under HealCrest Network, a spokesperson for EHS said in a May 14 statement shared with Becker’s.
    • “Hospital employees told KIAH that they did not receive pay on May 9; however, the hospital said it plans to repay them in the coming days.”
  • and
    • [Another article shows] “the adjusted expenses per inpatient day in 2023 for nonprofit, for-profit, and government hospitals in every U.S. state, based on the latest estimates provided by Kaiser State Health Facts. 
    • “The figures are based on information from the 2023 American Hospital Association Annual Survey. They are an estimate of the expenses incurred in a day of inpatient care and have been adjusted upward to reflect an estimate of outpatient service volumes, according to the KFF. 
    • “The foundation notes the figures are “only an estimate of expenses incurred by the hospital” for one day of inpatient care and do not substitute actual charges or reimbursement for care provided.
    • “To see how expenses compare to one year prior, find 2022’s adjusted expenses per inpatient day here. 
      • National average
      • Nonprofit hospitals: $3,288
      • For-profit hospitals: $2,529
      • State/local government hospitals: $2,857
  • Per a press release,
    •  “Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (together, Blue cross) today reported a combined after-tax first quarter net income of $37 million on revenue of $2.6 billion (1.4% net margin). These results reflect an operating and other loss of $9.8 million (-0.4% operating margin) and investment income of $46.8 million.
    • “The big story is that spending on medical and pharmacy services for our members remains elevated, at near historic highs,” said Chief Financial Officer Ruby Kam. “Two notable callouts in the first quarter involve higher spending due to the difficult flu season as well as the continued impact of high-cost GLP-1 medications.” Kam said the company projects operating and net losses for full-year 2025 and has implemented a comprehensive plan to improve its financial results. Last year, the company posted the worst operating loss in its 87-year history.
    • “Blue Cross is the leading private health plan in Massachusetts with 3 million members.”
  • Fierce Healthcare points out,
    • “Earlier this month, pharmacy chain Rite Aid filed bankruptcy for the second time in less than two years, revealing that it would seek buyers for its retail locations.
    • “In the Pacific Northwest, it’s garnering interest from pharmacy rival CVS Health, according to a report in Bloomberg. Rite Aid CEO Matthew Schroeder told employees on Thursday that CVS had made a bid on a large number of stores in Washington, Oregon and Idaho along with patient prescription data, according to a recording reviewed by the outlet.
    • “If a deal were to go through, it would give CVS greater reach in a region where its presence is currently smaller, per the article.
    • “Schroeder said that Rite Aid has also received bids on some of its assets from multiple other pharmacy groups, including Walgreens, Albertsons, Kroger and Giant Eagle, Bloomberg reported.”
  • Per an Institute for Clinical and Economic Research news release,
    • “Institute for Clinical and Economic Review Publishes Final Evidence Report on Treatment for Retinitis Pigmentosa. Independent appraisal committee voted that current evidence is adequate to demonstrate a net health benefit of sonpiretigene isteparvovec compared to usual care.”

Monday Report

David Ermer–ACA, CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • Roll Calls offers a summary of this week’s activities on Capitol Hill.
  • The Senate Majority Leader filed cloture today on Eric Ueland who is the President’s nominee for OMB Deputy Director. Mr. Ueland shared the stage with Mr. Kupor, the President’s nominee for OPM Director, at their Senate Homeland Security Committee confirmation hearing on April 3.
  • The American Hospital Association News tells us,
    • “The White House May 12 released an executive order to reduce prescription drug costs by allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in other countries. The order directs the Secretary of Health and Human Services to propose rules that impose most favored nation pricing and take other measures to reduce prescription drug costs.’ 
  • BioPharma Dive adds,
    • “In a press briefing on Monday, White House officials revealed key details in the order. HHS will communicate the most-favored-nation prices to drugmakers and establish a mechanism for selling them directly to consumers at that price. If companies don’t use those prices, a new figure would be set through negotiation or federal regulation.
    • “The White House will also ask the Food and Drug Administration to expand reimportation from countries with lower drug costs, officials said, though those requests would occur at a time of heightened tensions regarding global trade.
    • “The Department of Commerce and U.S. Trade Representative will additionally be instructed to take action against countries that keep their drug prices low, the officials added.”
  • The Wall Street Journal reports, “The pharmaceutical industry’s reaction to President Trump’s executive order on drug prices? It could have been worse.”
  • Per Fierce Healthcare,
    • “The Trump administration has issued new draft guidance for the third cycle of Medicare drug price negotiations.
    • “The proposals seek to boost transparency in the program and put a focus on negotiating for the drugs that come at the highest cost to Medicare. The agency is also aiming to avoid negative impacts from the negotiated prices on U.S.-based pharmaceutical innovation, according to an announcement.
    • “Under the guidance, drugs administered under Medicare Part B would be potentially included for the first time. The agency is looking for feedback in comments on how to manage access to the maximum fair price negotiated for Part B drugs.
    • “The guidance also outlines that CMS may choose to renegotiate the price for certain drugs already set for 2026 or 2027.”
  • Modern Healthcare tells us,
    • “A record 24.3 million people signed up for health insurance on federal and state-based marketplaces during the exchange open enrollment period for 2025.
    • “Fueled by enhanced subsidies enacted in 2021 and extended in 2022, the number blew past the record set a year ago by nearly 2.9 million — a 13% increase, the Centers for Medicare and Medicaid Services reported Monday. The more sizable tax credits will expire at the end of this year, barring a congressional renewal.”
  • The AHA New informs us,
    • “The AHA May 12 responded to the Office of Management and Budget’s April 11 request for information on regulatory relief, making 100 suggestions to the Trump administration to help reduce burden on hospitals and health systems. “The Trump administration has rightly pointed out that the health status of too many Americans does not reflect the greatness or wealth of our nation,” said AHA President and CEO Rick Pollack. “Excessive regulatory and administrative burdens are a key contributor, as they add unnecessary cost to the health care system, reduce patient access to care and stifle innovation.”  
    • “The AHA’s recommendations fall under four categories: billing, payment and other administrative requirements; quality and patient safety; telehealth; and workforce.”

From the judicial front,

  • On May 9 (although the FEHBlog did not find it until today), the Justice Department asked the U.S. District Court of the District of Columbia to hold the ERISA Industry Committee’s lawsuit challenging the legality of the 2024 federal mental health parity amendments in abeyance while the governing agencies decide whether to modify or rescind the amendments. Here is a Dropbox link to the motion. The government’s motion states in short:
    • “The Departments have informed undersigned counsel that they intend to reconsider the 2024 Rule at issue in this litigation, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation.” * * *
    • “The 2024 Rule has two applicability dates: plan years beginning on or after January 1, 2025, and plan years (in the individual market, policy years) beginning on or after January 1, 2026. On April 25, 2025, the Departments informed undersigned counsel that they intend to (1) issue a non-enforcement policy in the near future covering the portions of the 2024 Rule that are applicable for plan years beginning on or after January 1, 2025, and January 1, 2026, and (2) reexamine the Departments’ current MHPAEA enforcement program more broadly. To confer with Plaintiff about the requested stay, Defendants provided Plaintiff with a copy of the non-enforcement policy that they expect to publicly release memorializing their intention not to enforce the portions of the 2024 Rule that are applicable for plan years beginning on or after January 1, 2025, and January 1, 2026.” 
  • Today, the presiding Judge Timothy J. Kelly granted the motion and ordered the parties to file status reports every 90 days beginning August 7, 2025.

From the public health and medical research front,

  • STAT News lets us know,
    • “Health secretary Robert F. Kennedy Jr. and his lieutenants have sent multiple signals in recent weeks that they envisage a world in which far fewer people are urged to get Covid-19 shots each fall. They aren’t the first ones to suggest it.
    • “The Advisory Committee on Immunization Practices — the expert panel that has, until now, guided the nation’s vaccine policies — is already talking about changing policy in ways that would have this exact effect. A presentation from the group’s meeting last month suggests that, if they’re allowed to meet this summer, they’ll recommend annual shots for adults 65 and older, some younger adults with medical conditions that increase their risk of severe illness from Covid infection, including pregnant people, possibly health care workers, and some very young children. Read more from STAT’s Helen Branswell.”
  • MedPage Today points out,
    • [T]he mumps vaccine’s less-than-stellar performance is no secret. Infectious disease experts readily acknowledge that the mumps portion of the vaccine isn’t as good as the measles or rubella portions.
    • “We eliminated measles by 2000 and rubella by 2005, but we’ve never eliminated mumps,” Paul Offit, MD, of the Children’s Hospital of Philadelphia, told MedPage Today. “So it’s true that it’s not as good of a vaccine as those two.”
    • “Indeed, mumps cases occur every year, and there have been several “outbreak” years in the last two decades — but the CDC isn’t hiding that. It reports mumps cases on its website.
    • “And it doesn’t mean the baby should be thrown out with the bath water. In fact, the mumps vaccine “has dramatically reduced the incidence of mumps by about 99%,” since it was introduced in 1967, Offit said, highlighting the accompanying drop in incidence of acquired deafness.
    • “Mumps was the most common cause of acquired deafness in the U.S.,” Offit said. “Now, homes for the deaf have closed.”
    • “Mumps cases fell from more than 150,000 in 1968 to 357 in 2024, according to CDC data.”
  • and
  • Per BioPharma Dive,
    • “Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control and Prevention to recommend suspending use of Valneva’s chikungunya vaccine in people at least 60 years of age.
    • “The recommendation announced Monday comes days after the European Medicines Agency temporarily suspended use of the vaccine, known as Ixchiq, in those over 65 pending an investigation. A committee advising the CDC previously suggested a precaution for use in a similar age group.
    • “The FDA and CDC have upheld recommendations for use in adults between 18 and 60 years of age, while the EMA still endorses the shot for individuals between 12 and 64.”
  • The American Medical Association lets us know what doctors wish their patient knew about cancer screenings and prevention.
  • Consumer Reports, writing in the Washington Post, discusses, “how to ease IBS symptoms. Irritable bowel syndrome affects 10 to 15 percent of U.S. adults. Dietary and other changes can help.”
  • Per Fierce Pharma,
    • “The HER2-targeted antibody-drug conjugate that Pfizer gained from its Seagen buyout has delivered positive results in a pivotal study among Chinese patients with newly diagnosed bladder cancer, a readout that bodes well for the New York pharma’s own global phase 3 trial.
    • “A combination of the HER2 agent, called disitamab vedotin, and Junshi Biosciences’ PD-1 inhibitor toripalimab outperformed chemotherapy at both delaying tumor progression and extending patients’ lives as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma, RemeGen said Monday.
    • “The results came from an interim analysis of a Chinese phase 3 trial coded RC48-C016, which has now met its two primary endpoints of progression-free survival and overall survival, according to RemeGen. The company said the improvements were statistically significant and clinically meaningful.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente logged a 2.9% operating margin and 16.1% year-over-year jump in first-quarter operating revenues on the back of recent health system acquisitions through its Risant Health subsidiary, the Oakland, California-based integrated health system announced Friday.
    • “Year-over-year overall performance reflected a continued focus on affordability for members and customers and the addition of Risant Health revenues,” the system said.
    • “The topline results shared ahead of Kaiser’s required filings outline more than $31. 8 billion of operating revenues and $30.9 billion of operating expenses, both well above the $27.4 billion and $26.5 billion of Q1 2024.
    • “These translated to an operating income of $932 million for the quarter ended March 31, 2025, a slight decline from the prior year’s $935 million and 3.4% operating margin.”
  • Per Beckers Payer Issues,
    • On average, insurers pay 4.7% higher commercial prices to hospitals that are a part of their Medicare Advantage networks compared to those not in network, according to a study published May 8 in Health Services Research.
    • The study analyzed 5,654 insurer-hospital contracts across seven large insurers that offer both commercial (employer-sponsored and ACA) and MA health plans. The researchers used data from Turquoise Health, the American Hospital Association, and Clarivate, focusing on five commonly used services. 
    • “We compared inpatient negotiated commercial prices between insurers at the same hospital that do not include the hospital in their MA network and those that do,” the researchers wrote. “We used Poisson regression with hospital fixed effects, adjusting for insurer fixed effects and insurer-market covariates.” * * *
    • “We find suggestive evidence consistent with this ‘price-shifting’ hypothesis, where prices in the commercial market may be adjusted to secure agreement over MA networks. We find that insurers pay higher commercial prices to hospitals that are in their MA networks,” the researchers concluded.”
  • MedTech Dive notes,
    • “Roche Diagnostics will build a $550 million expansion to produce continuous glucose monitors at an Indianapolis facility. Roche will use the site to make its Accu-Chek Smartguide devices, which launched last year in Europe as the company’s first CGM.
    • “Our goal is to initiate production within three years, followed by preparing for future generations of that CGM solution,” Richeal Cline, head of global operations for Roche Diagnostics, said in a Monday press conference. 
    • “The Indianapolis site is Roche Diagnostics’ North American headquarters. It houses research and development, laboratories, manufacturing and other functions, and produces Roche’s Accu-Chek diabetes test strips. The facility is one of two global distribution hubs for the company.
    • “Roche will refurbish an existing building for the manufacturing space and may construct new buildings to meet future demand, Cline said.”
  • Beckers Hospital Review tells us,
    • “Walgreens is expanding its use of robotic micro fulfillment centers to handle prescription volume as part of a renewed push to streamline pharmacy operations and address staffing challenges, CNBC reported May 11.
    • “The company told the news outlet it plans to have its 11 automated facilities serve more than 5,000 stores by the end of 2025, up from 4,800 in February. 
    • ‘The centers, first introduced in 2021, use robots and conveyor systems to fill maintenance prescriptions for chronic conditions such as diabetes and high blood pressure. However, Walgreens had paused the expansion in 2023 to address performance issues and gather feedback from its stores. 
    • “The new expansion is aimed at reducing routine tasks for in-store pharmacy staff to free them up for more clinical work like vaccinations and health screenings, the report said.” 

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec reports,
    • “The U.S. Postal Service confirmed on Friday it will name David Steiner, a long-time CEO of Waste Management and FedEx board member, to become the nation’s 76th postmaster general, handing the reins to the executive while the mailing agency continues to reel financially and is in the midst of major political and operational disruption. 
    • “Steiner will succeed former Postmaster General Louis DeJoy, who resigned amid pressure in March, and Doug Tulino, who is currently the acting USPS chief. The Postal Service’s board of governors hired an outside firm to conduct a search to replace DeJoy and made the selection as required by law, though The Washington Post, which first reported Steiner’s selection, said President Trump and his administration pushed for the hire. 
    • “Still, the postal board threw its full weight behind Steiner. 
    • “Dave is the right person to lead the Postal Service at this time to ensure this magnificent and historic organization thrives into the future,” said Amber McReynolds, the board’s chair and a President Biden appointee. “Dave is a highly regarded leader and executive with tremendous vision, experience and skill that can be applied to the long-term mission and business needs of the Postal Service. 
    • “Steiner, who is expected to take over his new role in July, called it an “incredible honor” to be named as postmaster general. While Trump has floated the possibility of removing the Postal Service’s independent status, Steiner committed to it. He also vowed to work closely with postal unions, industry associations, customers and policymakers.”
       
  • The FEHBlog took a peek at reginfo.gov this morning, and he noticed the following:
    • “Department of Labor
      “AGENCY: DOL-EBSA RIN: 1210-AC30 Status: Pending Review
      “TITLE:Transparency in Coverage
      “STAGE: Prerule Economically Significant: No
      “RECEIVED DATE: 05/02/2025 LEGAL DEADLINE: None”
    • The FEHBlog expects that this prerule ties in with paragraph 12 of the President’s April 15, 2025, executive order on drug costs:
      • “Sec. 12. Improving Transparency into Pharmacy Benefit Manager Fee Disclosure. Within 180 days of the date of this order, the Secretary of Labor shall propose regulations pursuant to section 408(b)(2)(B) of the Employee Retirement Income Security Act of 1974 to improve employer health plan fiduciary transparency into the direct and indirect compensation received by pharmacy benefit managers.”
    • Evidently, you can request an EO 12886 meeting at this pre-rule stage. https://www.reginfo.gov/public/do/eoDetails?rrid=937013
  • On Monday, May 12, the Trump Administration must answer ERIC’s challenge to the legality of the 2024 mental health parity rule changes.  The FEHBlog reviewed the PACER docket sheet this morning, and the government has not asked for more time to answer beyond May 12. The Administration could resolve the case by withdrawing the rule making.
  • Per Radiology Business,
    • “Sen. Roger Marshall, MD, R-Kan., introduced legislation on Wednesday to boost Medicare payments for radiologists and other physicians. 
    • “The lawmaker is proposing the ‘‘Medicare Patient Access and Practice Stabilization Act of 2025.’’ This comes after Rep. Greg Murphy, MD, R-N.C., in January introduced the same bill in the U.S. House, which has now gathered 167 co-sponsors. 
    • “Marshall—who practiced as an OB-GYN specialist for 25 years before joining Congress—had not issued a statement about the proposal as of late Thursday. His office did not immediately respond to a Radiology Business request for comment.
    • “Anders Gilberg, senior VP of government affairs for the Medical Group Management Association, touted the bill on social media May 7. He said the initial proposal is to increase Medicare physician reimbursement by 8.51% starting on June 1.”

In Food and Drug Administration news,

  • MedCity News reports,
    • “On Friday, a San Francisco-based startup received FDA approval for the first-ever at-home cervical cancer test.
    • “The company, named Teal Health, was founded in 2020 and has raised $23 million. The startup has developed an at-home cervical cancer screening kit, which seeks to give patients an alternative to the in-office pap smear. 
    • “Many women don’t get a pap smear, which is the standard screening method for cervical cancer — CDC guidelines say that women should be tested regularly from ages 21-65, yet only 1 in 4 women of screening age get screened. Not only do many women struggle to find access to this exam, but many patients find the pap test to be uncomfortable and invasive.”
    • The article explains the at-home testing process.
    • “The startup is preparing to launch in California first, and it is already in network with Aetna, Cigna, UnitedHealthcare and Anthem Blue Cross Blue Shield, [CEO and founder Kara] Egan stated.
    • “We’re also in conversations with several large national payers to get this covered nationally. For us, the goal is to make sure it’s affordable for women,” she declared.
    • “She said Teal plans to start shipping tests to patients’ homes sometime next month.”
  • Per a National Institutes of Health news release,
    • “Today, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced a new, joint innovative research initiative that will serve as a key element in fulfilling U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr.’s commitment to Make America Healthy Again. With diet-related chronic diseases continually rising, it is imperative that the FDA and NIH work in lockstep to invest in gold standard science, prioritize a better understanding of the root causes to end the diet-related chronic disease crisis and safeguard the health of America’s children.
    • “Under the new Nutrition Regulatory Science Program, the FDA and NIH will implement and accelerate a comprehensive nutrition research agenda that will provide critical information to inform effective food and nutrition policy actions to help make Americans’ food and diets healthier. The initiative will aim to answer questions such as:
      • “How and why can ultra-processed foods harm people’s health?
      • “How might certain food additives affect metabolic health and possibly contribute to chronic disease?
      • “What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?
    • “Answering these questions and many others will enable effective policy development and help promote the radical transparency Americans deserve about the foods they are eating and how those foods can impact their health.”
  • To that end, an HHS news release announced that the FDA “granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.”
  • STAT News tells us,
    • “The FDA has granted accelerated approval to Verastem’s combination treatment for ovarian cancer. It licensed and has paired two drugs — avutometinib, an MEK inhibitor first developed by Roche subsidiary Chugai Pharmaceutical, with defactinib, an adhesion kinase blocker developed by Pfizer. The approval is for adults with a recurrent KRAS-mutated form of the disease who have already received systemic therapy.
    • “The approval of the treatment, called Avmapki Fakzynja, is based on a study of 57 pre-treated patients who showed a 44% overall response rate, with responses lasting up to 31 months. The company is also testing this combination in Phase 1/2 trial in patients with front-line metastatic pancreatic cancer.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low and declining.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.
    • “Vaccination
      • “New research finding: In the first RSV season with widespread availability of RSV prevention products (maternal vaccine and nirsevimab), RSV-associated hospitalization rates among infants were lower than in prepandemic seasons. A report released in the May 8, 2025, MMWR demonstrated that in 2024–25, RSV hospitalization rates were 45-52% lower in infants younger than 3 months old and 28-43% lower in infants younger than 8 months old compared to 2018-2020 seasons before product introduction.”
  • The University of Minnesota’s CIDRAP adds,
    • “A 2024-25 flu season that has been classified as high severity has now reached low transmission levels, but 10 new flu-related deaths in children bring the season’s total to 226, the most since 2009-10, when 288 pediatric deaths were recorded, according to the latest FluView update today from the Centers for Disease Control and Prevention (CDC).”
  • and
    • “In a weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 66 more measles cases, pushing the national total to 1,001 and in just over 4 months keeps the nation on track to pass the 2019 total, which marked the nation’s worst year since the disease was declared to be eliminated in 2000.
    • “The steady rise in cases is fueled by multiple outbreaks, with two more reported this week. The CDC is tracking 14 outbreaks that are responsible for 93% of cases.
    • “The Texas Department of State Health Services (TDSHS) today reported 7 more cases since its last update on May 6, lifting the state’s total to 709 confirmed patients, of whom 679 (96%) were unvaccinated or had an unknown vaccination status. The number of affected counties remained at 29, and most cases are in Gaines County, the outbreak’s epicenter.
    • “Five more hospitalizations were reported, putting that total at 92. The number of deaths remained at two.”
  • BioPharma Dive informs us,
    • “Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it’s been developing succeeded in two large clinical trials, setting the stage for an approval filing later this year.
    • “The drug is a reformulated version of an old medication, meloxicam, designed to more quickly treat the sharp, “acute” pain felt after an injury or operation.”

From the U.S. business healthcare front,

  • Fierce Healthcare reports,
    • “The American Medical Association (AMA) has announced John Whyte, M.D., as its new CEO and executive vice president, effective July 1.
    • “Whyte, a practitioner and author with experience at government agencies and private sector medical media outlets, will be taking over for James Madara, M.D. The outbound executive had shared plans to end his 14-year run last June.
    • “Unlike the physician association’s president and president-elect titles, which are voted on by membership for single-year terms, the CEO position is appointed by the AMA’s board of trustees for an open-ended tenure. They are tasked with overseeing the organization’s day-to-day operations.”
  • and
    • “Artificial intelligence assistants could ease the transition to value-based care for primary care practices, a new report by Phyx Primary Care found. 
    • “VBC can be administratively burdensome due to its enhanced reporting requirements. Primary care practices report that the transition to VBC is often long and results in a mix of VBC and fee-for-service billing practices. 
    • “In a study of 120 physicians who had used an AI scribe for 30 days or more, providers reported a 40% reduction in clinical review time for complex patients and a 32% decrease in physician burnout. The study was conducted by Phyx Primary Care, a nonprofit innovation lab that evaluates emerging technologies and evolving payment models.” 
  • Healthcare Dive relates,
    • “HCA Healthcare, Tenet Healthcare, Universal Health Services and Community Health Systems all posted financial results that beat Wall Street expectations for the first quarter of 2025. 
    • “Still, the health systems are maintaining their full-year outlooks as they exit the first quarter, despite most systems growing their revenue.” 
  • Per a press release,
    • Blue Cross Blue Shield of Massachusetts (“Blue Cross”) today announced a new virtual-first primary care option designed to support members’ health when and where they need it. CloseKnit, which provides virtual and in-person access to primary care, is now available to most Blue Cross members. This comes at a critical time as Massachusetts continues to face a primary care physician shortage.
    • As part of their agreement, CloseKnit is participating in Blue Cross’ value-based payment program and provides members with convenient and timely access to primary care.
    • Here is a link to CloseKnit’s website.

Thursday Report

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, SDOH, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Senate Press Gallery indicates that the Majority Leader John Thune (R SD) plans to file cloture motions on six Presidential nominees (not including Scott Kupor) on Monday. Nevertheless, this action gives the FEHBlog hope that Scott Kupor’s nomination to be OPM Director will be brought to Senate floor this month.
  • The American Hospital Association News tells us,
    • “Reps. Jennifer McClellan, D-Va., and Don Bacon, R-Neb., and Sens. Jeff Merkley, D-Ore., and Cindy Hyde-Smith, R-Miss., today reintroduced AHA-supported legislation addressing mental health and substance use disorder facility shortages. The Mental Health Infrastructure Improvement Act (H.R. 3266) would establish a new federal loan and loan guarantee program within the Department of Health and Human Services to build or renovate mental health or substance use disorder treatment facilities. At least a quarter of the funding would be reserved for pediatric- and adolescent-serving facilities. The bill would also prioritize facilities located in high-need, underserved or rural areas, and those capable of providing integrated care for patients with complex needs.”
       
  • Federal News Network informs us,
    • “The Office of Personnel Management is hoping the sole-source, one-year contract it just awarded to Workday, a cloud-based HR services company, will help the agency manage what’s turned into a massive influx of HR work.” * * *
    • “The contract with Workday will cover services for HR and personnel processing, payroll and benefits systems, time and attendance tracking, talent acquisition and performance management, all while ensuring compliance with federal requirements, according to the contract award notice.” * * *
    • “The Workday contract, worth $342,200, will last for one year, at the end of which OPM said it plans to conduct an open competition for the next iteration of the HR IT contract.”
  • Per an FDA news release,
    • “In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.
    • “I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” said Dr. Makary.
    • “The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.
    • “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER).”
  • Tammy Flanagan, writing in Govexec, lets us know how Social Security benefits fit into the federal retirement picture.

From the public health and medical research front,

  • Medpage Today points out,
    • “Detections of H5N1 avian influenza have slowed in both animals and humans, but continued surveillance is warranted, CDC researchers said.
    • “In dairy cattle, cases surged over the fall and early winter but eased in January, while cases in poultry flocks fell after February, and came down last month in backyard flocks, according to data on CDC’s website that was shared during a clinician outreach and communication activity (COCA) call on Tuesday.
    • “Most of our human cases are known to be associated with animal exposures, so fewer infections in the animals leads to fewer infections in people,” Alicia Budd, MPH, team lead of the national surveillance and outbreak response team at the National Center for Immunization and Respiratory Diseases (NCIRD), said during the call.
    • “It’s certainly great to see these declines in both animal and human cases, but it’s also critical that we maintain targeted monitoring and our general surveillance, so that if this situation changes, we’d be able to identify that quickly,” Budd added.”
  • and
    • “The nation’s infant mortality rate dropped last year after 2 years of hovering at a late-pandemic plateau.
    • “Some experts think one reason for the drop could be a vaccination campaign against respiratory syncytial virus (RSV)opens in a new tab or window, which is a common cause of cold-like symptoms that can be dangerous for infants.
    • “The infant mortality national rate dropped to about 5.5 infant deaths per 1,000 live births in 2024, according to provisional data from the CDC posted Thursday. That’s down from about 5.6 per 1,000 live births, where it had been the previous 2 years.
    • “CDC officials believe the findings will not change much when the final numbers come out later this year.”
  • Per Healio,
    • “Tobacco-related ischemic heart disease mortality has increased in the U.S. since 1999.
    • “The aging of the population and the introduction of novel nicotine products may be among the drivers.”
  • and
    • “A risk prediction model assesses seven variables to determine the best intervention for lowering type 2 diabetes risk.
    • “Intensive lifestyle intervention was the optimal treatment strategy for most adults.”
  • Per Cardiovascular Business,
    • “Cardiovascular risk factors such as obesity and high blood pressure are much more prevalent in some parts of the United States than others—and some of those gaps are only widening as time goes on. 
    • “That was the biggest takeaway from a new analysis published in The American Journal of Cardiology. The study’s authors reviewed answers to the Behavioral Risk Factor Surveillance System (BRFSS) survey from 2011 to 2021 to track changes in various health inequities over time.
    • “Delays in preventive care and screening as well as economic loss, disruptions in insurance coverage and worsening social determinants of health (food insecurity, housing instability) have fallen more heavily on low-income, minority and rural communities since the pandemic,” wrote first author Rachel K. Gardner, MD, a researcher with Beth Israel Deaconess Medical Center and Brigham and Women’s Hospital, and colleagues. “In addition, the spillover effects of the pandemic have disproportionately impacted some U.S. states more than others. Together, these changes could have profound implications for cardiovascular health across the country. However, little is known about how inequities in the burden of cardiometabolic and lifestyle risk factors across U.S. states have changed, especially since the pandemic. Understanding these epidemiological changes in place-based inequities is critically important and could inform targeted public health and policy interventions at the state- and national-level to advance cardiovascular health.”
    • “The BRFSS survey is the world’s largest continuous health survey of its kind, collecting data from more than 400,000 adult participants each year. Gardner et al. based their comparison on data from 506,467 adults who participated in the survey in 2011 as well as 438,693 who participated in 2021.” * * *
    • Click here for the full study.
  • Beckers Hospital Review reports,
    • “Moderna’s new combination vaccine for seasonal influenza and COVID-19 has outperformed current standard vaccines in a large phase 3 clinical trial, showing stronger immune responses to both viruses in adults 50 years or older. 
    • “The findings, published May 7 in JAMA Network, come from a randomized study of more than 8,000 participants conducted across 146 U.S. sites. Participants either received the investigational combo vaccine mRNA-1083 or the standard influenza and COVID-19 vaccines recommended for their age group. 
    • “Among adults ages 50 to 64, mRNA-1083 generated a stronger immune response against all four influenza strains. In adults 65 and older, it outperformed the high-dose flu vaccine in three of the four strains. In both age groups, the vaccine also produced higher immune responses to SARS-CoV-2 compared to standard COVID-19 vaccine.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have completed a comprehensive analysis of cancer statistics for different age groups in the United States and found that from 2010 through 2019, the incidence of 14 cancer types increased among people under age 50. Of these cancer types, nine—including several common cancers, such as breast cancer and colorectal cancer—also increased in some groups of people aged 50 and older. However, the incidence of 19 other cancer types—including lung cancer and prostate cancer—decreased among people under age 50, so the total rate of all cancers diagnosed in both younger and older age groups did not increase, nor did the rate of cancer death.
    • “This study provides a starting point for understanding which cancers are increasing among individuals under age 50,” said lead investigator Meredith Shiels, Ph.D., of NIH’s National Cancer Institute. “The causes of these increases are likely to be cancer specific, including cancer risk factors becoming more common at younger ages, changes in cancer screening or detection, and updates to clinical diagnosis or coding of cancers.”
    • “The study appeared May 8, 2025, in Cancer Discovery“.
  • The National Cancer Institute adds,
    • “Scientists have developed a method of rapidly measuring the levels of certain genetic mutations in brain tissue samples collected from patients during surgery. 
    • “In a new study, researchers showed that the droplet digital polymerase chain reaction (ddPCR) method they developed could produce results in 15 minutes—the first time ddPCR has generated results so quickly. 
    • “Their tool accurately measured the levels of tumor cells in dozens of brain tissue samples, they reported. And it detected minute numbers of cancer cells, as few as five cells per square millimeter, according to findings published February 25 in Med.
    • “The researchers developed the tool, which they call Ultra-Rapid ddPCR, to provide surgeons with information that could potentially help guide their decision-making during surgery.
    • “This new technology could be an additional source of information for a surgeon who is deciding whether to keep removing tissue during an operation,” said study co-leader Daniel Orringer, M.D., a neurosurgeon at NYU Grossman School of Medicine. “If the test detects tumor cells at a surgical margin, then surgeons could decide to keep cutting.”

In Food and Drug Administration News,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS). 
    • “This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
    • “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
  • Per Medical Economics,
    • “BrightHeart, a Paris-based artificial intelligence company for obstetrics and pediatric cardiology, announced it has received FDA 510(k) clearance for an updated version of its BrightHeart platform. The new approval allows clinicians to access the company’s AI-driven analysis in real time using a cart-side tablet during fetal ultrasound exams.
    • “The technology aims to address a persistent clinical challenge: detecting congenital heart defects (CHDs) in utero. CHDs are the most common type of birth defect, but up to 70% go undiagnosed during standard prenatal ultrasounds, according to the company.
    • “BrightHeart’s AI platform flags potential structural abnormalities in the fetal heart, helping to alert clinicians to possible CHDs during routine exams. The company says the real-time tablet integration streamlines workflows and improves the accuracy of screenings.
    • “Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy,” said Cécile Dupont, CEO of BrightHeart and partner at Sofinnova Partners. “We were thrilled to achieve clearance through our first Special 510(k) submission within just a few months.”

From the U.S. healthcare business front,

  • Medical Economics reports,
    • “Nonphysician providers now make up more than two out of every five health care professionals in the United States, as hospitals and medical groups increasingly rely on advanced practice providers to meet growing patient demand and improve efficiency, according to a new report from Kaufman Hall.
    • “The Physician Flash Report, released by the health care consulting firm and its parent company Vizient, found that 40.6% of the nation’s provider workforce is composed of APPs such as nurse practitioners and physician assistants. The report points to continued growth in this segment and predicts that APPs and physicians may soon comprise equal halves of the clinician workforce.
    • “Advanced practice providers like physician assistants and nurse practitioners play a vital and increasingly visible role in health care,” said Matthew Bates, managing director and Physician Enterprise Service Line leader with Kaufman Hall. “When deployed correctly, advanced practice providers let physicians practice at the top of their license. They give doctors more time to focus on diagnosis and treatment, which can make physician practices more efficient and address other challenges, including physician burnout.”
  • Reuters tells us,
    • “Another Big Pharma is opening up its wallet to pour billions into its U.S. operations amid political pressure from the Trump administration.
    • “This time it’s Gilead coming to the table with a fresh $11 billion in hand to spend across its manufacturing and research centers in the U.S.
    • “Gilead broke down the new spending routes in a Wednesday release. The majority, $5 billion, will be funneled into technology, operations, and R&D site activities, while $4 billion will go into capital projects, including labs and equipment. The final $2 billion will be “invested in digital and advanced engineering initiatives,” the pharma said.”
  • The White House summarized all of these drug manufacturing investments here.
  • Fierce Healthcare relates,
    • “Ayble Health, a virtual GI clinic, has teamed up with Priority Health, a nonprofit health plan in Michigan, to offer commercial members access to the digestive health solution. 
    • “Ayble relies on a multidisciplinary care team, AI-powered nutrition and psychology programs and wellness tools to manage symptoms. Starting June 1, Ayble will be available as a standard benefit for Priority members who have a MyPriority HMO or employer health plan. More than 500,000 adult members will have access. 
    • “When it comes to sourcing solutions like Ayble Health, Priority Health looks for approaches that can improve care quality, engage patients effectively and provide cost-efficient services,” Alicia Coronas, vice president of employer solutions product and marketing at Priority, told Fierce Healthcare. “We evaluate solutions to find the best-in-class partner that is aligned to our vision and mission.”

Wednesday Report

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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