Thursday report

COVID-19 vaccine

Thursday report

David Ermer–CDC, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • MedPage Today tells us,
    • “HHS Secretary Robert F. Kennedy Jr. last month quietly endorsed recommendations from his handpicked vaccine advisors that everyone in the U.S. ages 6 months and older receive a flu shot for the upcoming season.” * * *
    • “ACIP reaffirms the recommendations for routine annual influenza vaccination of all persons aged ≥6 months who do not have contraindications for the 2025-2026 season,” the ACIP page states. “With no current CDC Director and pending confirmation of a new CDC Director, this recommendation was adopted by the HHS Secretary on July 22, 2025, and is now an official recommendation of the CDC.”
    • “A new CDC director, Susan Monarez, PhD, is now in place. * * *
    • “Another ACIP recommendation from the June meeting earned an endorsement Aug. 4 from Monarez. ACIP called for infants younger than 8 months who were born during or entering their first respiratory syncytial virus (RSV) season who are not protected by maternal vaccination to receive one dose of clesrovimab (Enflonsia)opens in a new tab or window. The monoclonal antibody joins a similar long-acting shot, nirsevimab (Beyfortus),opens in a new tab or window as an option for this population.”
  • Beckers Hospital Reviews lets us know six things about the tariffs that took effect today.
  • Federal News Network informs us,
    • “The Postal Service’s board of governors is urging its regulator not to put limits on its ability to set higher mail prices, after posting another multibillion-dollar quarterly net loss.
    • “USPS posted a $3.1 billion net loss for the third quarter of fiscal 2025 — a greater loss than the $2.5 billion net loss it saw for the same period last year.
    • “But Postmaster General David Steiner said USPS is “on the right path,” under a 10-year reform plan launched by his predecessor, former Postmaster General Louis DeJoy.
    • “The strategy is sound. Now we have to execute,” Steiner said during a public meeting of the USPS Board of Governors on Thursday. “But we can’t execute unless all of our team is working together. We all need to be rowing the oars in the same direction.”
  • Healthcare Dive relates,
    • “Amwell has extended a contract with the Defense Health Agency to support virtual care at the military health system, one of the company’s most significant growth initiatives, for another year, the telehealth vendor said Tuesday. 
    • “However, the deal cut out deployments for Amwell’s behavioral health and automated care programs “due to budget restrictions being broadly enforced by the Department of Defense,” CEO Ido Schoenberg said during a second quarter earnings call on Tuesday. 
    • “The contract change led the telehealth firm to revise its guidance for 2025. Amwell now expects revenue from $245 million to $250 million this year, down from its previous outlook of $250 million to $260 million.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration Aug. 7 announced a new program to help improve the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of drug manufacturing facilities in the U.S. The program, called FDA PreCheck, was created in response to a May 5 executive order, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs the FDA to streamline and accelerate the development of domestic pharmaceutical manufacturing by eliminating unnecessary or duplicative regulations and improving inspection processes. 
    • “The program consists of a two-phase approach to facilitate new manufacturing facilities. The first provides manufacturers with more frequent FDA communication during stages such as facility design, construction and pre-production. The second focuses on streamlining development of the chemistry, manufacturing and controls section of the drug application through pre-application meetings and early feedback.” 
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Thursday lifted its recommendation to pause use of Valenva’s chikungunya vaccine Ixchiq in older adults but added new warnings about the shot’s risks and limited who is eligible to receive it.
    • “The FDA’s action follows a similar move by the European Medicines Agency, which had paused use along similar lines as the FDA. However, the U.S. regulator’s changes to Ixchiq’s labeling appear likely to curtail how broadly its used in the future.
    • “Vaccination with Ixchiq is not advisable for most U.S. travelers. For most U.S. travelers, the risk of exposure to chikungunya is low,” the updated label says.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care flagged a problem with certain t:slim X2 insulin pumps where a wiring issue with certain devices’ speakers can cause them to malfunction and stop delivering insulin. 
    • “Tandem said it has received reports of 700 adverse events and 59 injuries. There have been no reports of death. The problem, if not addressed, presents the risk of hyperglycemia in people with diabetes. The company said in a Thursday announcement that it has also alerted the Food and Drug Administration and regulators outside of the U.S. 
    • “The company sent a letter to customers in July. The FDA has not yet posted the device correction in its recall database.”
  • Fierce Pharma adds,
    • “When Jazz Pharmaceuticals’ incoming CEO Renee Gala takes the reins at the drugmaker next week, she’ll have a brand-new launch to manage.
    • “Wednesday, the FDA approved Jazz’s Modeyso (dordaviprone) for patients ages 1 and older with H3 K27M-mutant diffuse midline glioma who have progressive disease following prior therapy. The drug, picked up in the company’s $935 million buyout of Chimerix earlier this year, is the first systemic therapy for those with the aggressive brain cancer.”

From the judicial front,

  • Healthcare Dive reports,
    • “UnitedHealth and Amedisys have agreed to a settlement with the Department of Justice, clearing the path for their $3.3 billion merger to go through.
    • “The settlement, filed with the Maryland district court on Thursday, requires UnitedHealth and Amedisys to divest certain businesses in order to placate the DOJ’s concerns that the merger is anticompetitive. Amedisys has also agreed to pay a $1.1 million civil penalty to the U.S. for not fully complying with regulators during the merger review process.
    • “Regulators’ tentative greenlight of the multibillion-dollar deal is a win for UnitedHealth, which originally proposed plans to acquire the home health and hospice provider in 2023. However, the merger has been tied up in litigation after the DOJ and four states sued to block it in November.”
  • Per Fierce Healthcare,
    • “The drug price negotiation program has withstood another procedural effort in striking down one of the Inflation Reduction Act’s most significant provisions.
    • “In the U.S. Court of Appeals for the 6th Circuit, a panel of judges upheld (PDF) a lower court’s decision to dismiss the lawsuit.
    • “A judge dismissed the lawsuit last year, saying most of the plaintiffs lacked standing to bring the case, but the U.S. Chamber of Commerce was able to file a new suit. The U.S. Chamber could now appeal to the Supreme Court, reported The Hill.”
  • The Hill adds,
    • “Federal judges in Texas and Connecticut on Thursday ruled against arguments challenging the constitutionality of the Medicare Drug Price Negotiation Program, delivering two more blows to the pharmaceutical industry this week after an appeals court upheld the dismissal of a similar case.
    • “In Connecticut, the U.S. 2nd Circuit Court of Appeals upheld (PDF) a decision granted by U.S. District Judge Michael P. Shea last year against pharmaceutical company Boehringer Ingelheim. The company’s diabetes medication Jardiance was among the first 10 drugs chosen for Medicare negotiations, and two more of its products were chosen for the following round of negotiations.”
    • “In Texas, U.S. District Judge David Alan Ezra dismissed the lawsuit brought forward by the trade group PhRMA with prejudice, closing the case.”

From the public health and medical research,

  • The Wall Street Journal reports,
    • “Ultraprocessed foods make up the majority of calories Americans are eating, according to a report released Thursday by the federal government. But there are signs this consumption might be declining.
    • “Sandwiches, baked goods, salty snacks and other ultraprocessed foods accounted for 55% of the calories Americans age 1 and older consumed from August 2021 to August 2023, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics study. 
    • “That proportion is getting smaller. For adults, the mean percentage of calories consumed from ultraprocessed foods fell 3 percentage points to 53% since 2018 and for children and teens, it fell nearly 4 percentage points to 61.9%, the report found.
    • “Statistically, the decline is significant,” said Anne Williams, a senior service fellow at the CDC and lead author of the report. For adults consuming around 2,000 calories a day, the drop between the 2017 to 2018 figures and the latest report translates to around 60 fewer calories a day coming from ultraprocessed foods on average, said Williams.
    • “Ultraprocessed foods have been linked to an array of health issues, including obesity, Type 2 diabetes, cancer, cardiovascular disease and depression. There isn’t a set definition for ultraprocessed foods but researchers consider them foods made with ingredients not normally found in a home kitchen, including high-fructose corn syrup and emulsifiers such as soy lecithin.”
  • MedPage Today adds,
    • “Eating French fries multiple times a week was associated with a higher risk of type 2 diabetes, though this wasn’t the case for baked, boiled, or mashed potatoes, researchers said.
    • “For every increment of three servings weekly of French fries, the rate of type 2 diabetes increased by 20% (95% CI 1.12-1.28), and for every increment of three servings weekly of total potato, the rate increased by 5% (95% CI 1.02-1.08), reported Walter Willett, MD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues.
    • “However, consumption of combined baked, boiled, or mashed potatoes was not significantly associated with risk of type 2 diabetes (pooled HR 1.01, 95% CI 0.98-1.05), they noted in The BMJ.
    • “Importantly, our substitution analysis showed that replacing all forms of potatoes — especially fries — with whole grains was linked to a lower risk of type 2 diabetes, whereas swapping them for white rice was associated with the opposite effect,” co-author Seyed Mohammad Mousavi, PhD, also of the Harvard T.H. Chan School of Public Health, told MedPage Today. “This reinforces that it’s not just about the potato itself, it’s about how it’s prepared and what foods it’s replacing in the diet.”
  • Genetic Engineering and BioTechnology News reports,
    • “Parkinson’s disease (PD) is the second-most common neurodegenerative disorder after Alzheimer’s and is caused by the degeneration of dopamine-producing neurons in the brain, leading to motor dysfunction, such as tremors and slowed movements.  
    • “Vamsi Mootha, MD, institute member at the Broad Institute, explains that a striking epidemiological association exists between heavy smoking and lowered PD risk. As smoking causes elevated carbon monoxide exposure which disrupts oxygen delivery by hemoglobin, he speculates that a low oxygen state in the brain may offer an unexpected protective mechanism against this incurable neurological disease that affects more than 10 million people worldwide. 
    • “In a new study published in Nature Neuroscience titled, “Hypoxia ameliorates neurodegeneration and movement disorder in a mouse model of Parkinson’s disease,” Mootha’s lab has now shown that low oxygen environments, similar to the thin air found at Mont Blanc, which reaches an elevation of approximately 16,000 feet, can successfully recover neuron function and alleviate motor symptoms in mice with Parkinson’s-like disease.:
    • * * * “The fact that we actually saw some reversal of neurological damage is really exciting,” said Mootha in a public release. “It tells us that there is a window during which some neurons are dysfunctional but not yet dead—and that we can restore their function if we intervene early enough.”
  • Health Day relates,
    • “Vaccination with the updated COVID-19 mRNA vaccine containing the severe acute respiratory syndrome coronavirus-2 Omicron JN.1 lineage [the fall 2024 vaccine] was not associated with an increased risk for 29 adverse events, according to a study published online July 28 in JAMA Network Open.
    • “Niklas Worm Andersson, M.D., Ph.D., from Statens Serum Institut in Copenhagen, Denmark, and colleagues examined the association between vaccination with JN.1-containing vaccines and the risk for 29 serious adverse events adapted from prioritized lists of adverse events of special interest to COVID-19 vaccines. Outcome rates during the first 28 days after JN.1-containing vaccine administration (i.e., the risk period) were compared to outcome rates during the remaining period.”
  • Per MedPage Today,
    • “Superagers — a group of adults over age 80 with the memory capacity of much younger people — maintained good brain morphology, tended to be gregarious, and appeared to be resistant to neurofibrillary degeneration and resilient to its consequences, more than two decades of research showed.
    • “In contrast to neurotypical peers who had age-related brain shrinkage, this group had a region in the cingulate gyrus that was thicker than younger adults, reported Sandra Weintraub, PhD, of Northwestern University Feinberg School of Medicine in Chicago, and colleagues.
    • “Superagers also had fewer Alzheimer’s-related brain changes, greater size of entorhinal neurons, fewer inflammatory microglia in white matter, better preserved cholinergic innervation, and a greater density of evolutionarily progressive von Economo neurons, Weintraub and colleagues wrote in a perspective piece in Alzheimer’s & Dementia.
    • “No particular lifestyle was conducive to superaging, the researchers said. Some superagers appeared to follow all conceivable recommendations for a healthy life. Others did not eat well, enjoyed smoking and drinking, shunned exercise, suffered stressful life situations, and did not sleep well.
    • “Superagers also did not seem to be medically healthier than their peers and took similar medications as they did. However, the superager group was notably sociable, relishing extracurricular activities. Compared with their cognitively average peers, they rated their relationships with others more positively. On a self-reported questionnaire of personality traits, they tended to endorse high levels of extraversion.
    • “It wasn’t the social and lifestyles aspects of superaging that surprised the researchers; it was “really what we’ve found in their brains that’s been so earth-shattering for us,” Weintraub said in a statement.”

From the healthcare artificial intelligence front,

  • Fierce Healthcare informs us,
    • “OpenAI released its most advanced reasoning model, GPT-5, which it touts as its most useful model for healthcare.
    • “The application of ChatGPT for healthcare played a leading role in the company’s Summer Update meeting on Thursday, during which it did live demos of the upgraded model. 
    • “Sam Altman, CEO of OpenAI, said health is one of the top reasons consumers use ChatGPT, saying it “empowers you to be more in control of your healthcare journey.” The company prioritized improving its healthcare features for this version of the product, Altman said. 
    • “GPT-5 will be available on the free version of the ChatGPT app, which means more consumers could start to rely on the product for assistance in making treatment decisions, understanding test results and determining what questions they should ask their doctors in the clinic.” 
  • Beckers Health IT points out,
    • “Oakland, Calif.-based Kaiser Permanente has been experimenting with AI in its patient portal, increasing patient engagement and experience in the process.
    • “The health system’s Southern California Permanente Medical Group, headquartered in Pasadena, launched the Kaiser Permanente Intelligent Navigator for its 4.9 million patients in October. The platform allows patients to chat with AI via a text box to book appointments and connect with the care they need.
    • “Care is local, but at the same time it’s virtual and it’s become a global commodity,” Khang Nguyen, MD, assistant executive medical director for care transformation at Southern California Permanente Medical Group and chief medical officer of care navigation for the Permanente Federation, told Becker’s. “So patients are really expecting artificial intelligence to support healthcare in a way that is supporting other industries, in the sense that people are able to describe what they want versus being given choices.” * * *
    • “In a study that evaluated nearly 3 million patient encounters using the AI between October and March, the tool detected urgent medical issues with 97.7% accuracy and recommended appropriate care paths with 88.9% accuracy. Patients successfully booked appointments more than half the time, compared to the industry average of 30%. The portal’s patient satisfaction scores went up by about 9%.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly shares plunged about 14% in midday trading Thursday after the company reported less-than-stellar results of a new study of an experimental anti-obesity pill that is expected to become a blockbuster.
    • “The pill helped people lose up to about 12% of their body weight after more than a year of treatment. The results could clear the way for the shot alternative to be on the market next year, but the magnitude of weight loss fell short of Wall Street expectations.
    • “The drugmaker also raised its earnings outlook for the year after revenue surged in its latest quarter on continued demand for its weight-loss and diabetes treatments.”
    • “The Lilly pill, orforglipron, is expected to become a big seller if regulators approve it for sale. Morgan Stanley analysts had said that under their bull-case scenario, the drug’s use for both obesity and diabetes could generate annual sales of up to $40 billion by 2033.
    • “Yet the latest clinical-trial results may dent some of that enthusiasm. The magnitude of weight loss fell short of what some analysts were predicting: 13% to 15% or more. 
    • “The Lilly pill is one of two that could hit the market within the next year or so, ushering in a new chapter of the weight-loss drug boom. Novo Nordisk has applied for regulatory approval of an anti-obesity pill version of its Ozempic and Wegovy, which could become available by the end of this year.”
  • Modern Healthcare relates,
    • “Aetna will end nearly 90 Medicare Advantage plans across 34 states in 2026, the company notified third-party sellers this week.
    • “The CVS Health subsidiary’s financial performance has represented a bright spot in the Medicare Advantage market compared with competitors such as UnitedHealth Group. This month, CVS Health raised its annual earnings guidance amid a $2 billion turnaround plan. The company cut the second-most plans in 2025, after Humana.
    • “The majority of the Medicare Advantage plans Aetna plans to eliminate next year are PPOs. Beginning in September, Aetna will stop paying commissions to brokers that enroll new members in these plans, according to a notice the company distributed to brokers on Monday.”
  • and
    • “UPMC and GoHealth Urgent Care have rebranded 81 urgent care centers as part of a joint venture between the two organizations. 
    • “The centers span Pennsylvania and West Virginia and offer care for non-life-threatening ailments, including flu, fever, earaches, insect bites, sprains, simple fractures and cuts requiring stitches. They will also offer virtual care options and are staffed with UPMC clinicians, according to a Thursday news release.
    • “The centers were previously owned by UPMC, including sites it acquired last month from MedExpress, another urgent care provider. Financial details of the joint venture were not disclosed.” 
  • Beckers Payer Issues adds,
    • “As major insurers pull back on their Medicare Advantage offerings, health system-owned plans told Becker’s they’re eyeing an opportunity to regain ground ahead of the annual enrollment season.” * * *
    • “I do think it’s an opportunity. Over time, the playing field is going to level somewhat, which is going to be a challenge for the nationals. For the community health plans, I think it’s going to be a benefit,” Rob Hitchcock, president and CEO of Intermountain’s Select Health, said.
    • “What you want is a healthy mix. You do want the national players to be strong, but you also want the community health plans to be strong,” he added.
  • NFP, an Aon company, discusses pharmacy deserts.
    • “A pharmacy desert is more than just a rural problem. It’s any area, urban, suburban or rural, where people lack reasonable access to a pharmacy. That usually means:
      • “More than one mile away in urban areas.
      • “Two miles in suburban areas.
      • “10 miles in rural regions.
    • “However, distance isn’t the only factor. Even if a pharmacy technically exists nearby, lack of public transportation, limited hours or closures of independent stores can make access nearly impossible, particularly for lower-income communities or those with mobility challenges.” * * *
    • “Pharmacy deserts are growing, and they have real consequences for employee health, equity and cost. While benefit consultants cannot control the closures, clients can guide their employees toward solutions that help their people stay healthy and protected, no matter where they live.”

Thursday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, SCOTUS, SDOH, U.S. Healthcare–

From Washington, DC,

  • On July 2, 2025, the U.S. Office of Personnel Management’s Inspector General issued a Flash Report titled “OPM’s Postal Service Health Benefits Program: Critical Resource Issues,” which Govexec discusses here. The FEHBlog believes and has repeatedly stated that the eligibility program for FEHB and PSHB could be vastly improved if OPM used the widely adopted HIPAA 820 Electronic Enrollment Roster Transaction. The HIPAA 820 transaction would allow carriers to promptly and systematically identify situations where no, or an incorrect, premium payments.
  • The American Hospital Association News reports,
    • Senior leaders from the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, along with White House representatives, visited pharmaceutical company Phlow Corp.’s new production system that manufactures key starting materials, active pharmaceutical ingredients and finished dose forms for 15 medicines used in the U.S. health system. Phlow laboratories and manufacturing facilities are located in the Mid-Atlantic, keeping the complete manufacturing cycle contained in one region. HHS-ASPR and Phlow have collaborated since May 2020 to bring pharmaceutical supply chains into the U.S. and reduce dependency on foreign countries. China and India, for example, account for more than 70% of APIs and KSMs imported to the United States. 
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today unveiled its groundbreaking Functional Repair of Neocortical Tissue (FRONT) program, a transformative initiative to restore brain function and position the U.S. as the global leader in brain repair technology. The FRONT program aligns directly with the priorities set by President Trump and Secretary Robert F. Kennedy, Jr., demonstrating a strong commitment to innovation, public health, and the economic well-being of the American people.
    • “Millions of Americans are living with the damage caused by strokes and traumatic brain injuries. Current treatments are not enough. ARPA-H hopes to deploy regenerative medicine to transform the treatment of neurological diseases and relieve the suffering,” said HHS Deputy Secretary Jim O’Neill.
    • ‘The neocortex, the largest part of the brain, is critical for sensory perception, motor control, and decision-making. Damage to this area—due to conditions like stroke, traumatic injury, or neurodegeneration, such as Alzheimer’s disease—has long led to irreversible damage, leaving individuals dependent on costly therapies or caregivers. The FRONT program aims to change that, using cutting-edge neurodevelopmental principles and stem cell technology to regenerate brain tissue and restore lost functions.”
  • The Brown & Brown actuarial consulting firm helpfully summarizes here the employee benefit provisions of the One Big Beautiful Act.
  • CMS announced resources and flexibilities to address the public health emergency in the State of Texas.

From the judicial front,

  • Govexec reports,
    • “The federal judge who temporarily blocked the Trump administration from implementing mass layoffs before the Supreme Court intervened has suggested she still plans to litigate the legality of individual agency workforce reduction plans. 
    • “The high court this week struck down the injunction that impacted most major agencies, allowing the administration to move forward with widespread RIFs. New layoff notices have not gone out since that decision on Tuesday, but they are expected imminently at several agencies. The court made clear, however, that its ruling applied only to the overall finding of President Trump’s capacity to order staffing cuts and not to the legality of individual agency RIF plans. 
    • “The content of those individual plans “thus remains squarely at issue in this case,” California-based U.S. District Judge Susan Illston, whose original decision led to the RIF pause, said in a new order Wednesday evening.” * * *
    • “Attorneys for the Trump administration previously noted it had 40 RIF actions underway at 17 agencies that were paused by Illston’s injunction. The federal employee unions, local governments and non-profit organizations that originally brought the lawsuit issued an “urgent request” following the Supreme Court decision asking the administration to submit those plans to the court for a decision on their legality. Illston ordered the administration to reply to that request by Monday and suggested she agreed the plans should be submitted for examination. 
    • “The administration previously argued it could not release them because they were predecisional and subject to executive privilege, but the judge on Wednesday suggested that final decisions on the RIFs must have been made if her injunction had paused them from taking effect. She added the court was “not inclined” to allow for significant redactions.” 
    • Here is a Dropbox link to the Court’s order.
  • The New York Times adds,
    • “A federal judge on Thursday blocked the Trump administration from enforcing a contentious executive order ending birthright citizenship after certifying a lawsuit as a class action, effectively the only way he could impose such a far-reaching limit after a Supreme Court ruling last month.
    • “Ruling from the bench, Judge Joseph N. Laplante of the U.S. District Court for the District of New Hampshire said his decision applied nationwide to babies who would have been subject to the executive order, which included the children of undocumented parents and those born to academics in the United States on student visas, on or after Feb. 20.
    • “The Trump administration has fought to challenge the longstanding law, laid out in the Constitution, that people born in the United States are automatically citizens, regardless of their parents’ immigration status. Judge Laplante’s order reignites a legal standoff that has been underway since the beginning of President Trump’s second term.
    • “The judge, an appointee of President George W. Bush, issued a written order formalizing the ruling on Thursday morning. He also paused his order for seven days, allowing time for an appeal.”

From the Food and Drug Administration front

  • BioPharma Dive lets us know,
    • The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased risk for COVID disease.
    • The shot was previously available for these individuals under emergency use authorization. The company said it expects to have an updated version of its shot available in time for the 2025-2026 respiratory disease season.
    • In May, Health and Human Services Secretary Robert F. Kennedy Jr. announced that COVID vaccines would no longer be recommended for healthy children and pregnant people. The Centers for Disease Control and Prevention currently recommends shared clinical decision-making for healthy children.

From the public health and medical research front,

  • The American Journal of Managed Care tells us,
    • “Ovarian cancer mortality rates have declined, but disparities exist across age, race, and geographic regions, with older women and non-Hispanic White women having the highest rates.
    • “Despite treatment advances, late-stage diagnosis remains a barrier due to the lack of routine screening, resulting in low survival rates for advanced-stage ovarian cancer.
    • “Geographic disparities show the Northeast with the highest mortality rates, while both metropolitan and non-metropolitan areas experienced declines, with metropolitan areas showing a steeper decline.
    • “The study’s limitations include the absence of individual-level data on lifestyle factors, tumor histology, and treatment protocols, hindering causal conclusions.”
  • Radiology Business points out,
    • “Shared decision-making visits significantly boost patients’ adherence to low-dose CT lung cancer screening, according to new research published Wednesday. 
    • “Numerous studies have explored poor uptake of LDCT, with rates as low as 18% among eligible individuals.
    • “Researchers with the American College of Radiology’s Neiman Policy Institute recently explored whether “shared decision-making” visits—required by Medicare as part of CT referrals—can boost screening adherence. They found a clear correlation, with imaging rates nearly 27% higher than those who did not meet with their primary care provider to discuss their risks and benefits of lung cancer screening, according to the study results, published in Chest. 
    • “Shared decision-making is more than just a billing requirement—it’s a valuable opportunity to engage patients in informed, personalized discussions about screening,” study author Farouk Dako, MD, MPH, associate professor of radiology, with the Perelman School of Medicine in Philadelphia, said in a July 9 announcement from the Policy Institute. “There is an opportunity to leverage this new evidence in national campaigns to raise awareness of lung screening and the importance of prioritizing SDM in routine clinical care to improve early detection and outcomes for one of the deadliest forms of cancer.” 
  • Gen Edge relates,
    • Scientists have produced the first detailed characterization of the changes that weight loss (WL) causes in human adipose tissue (AT) by analyzing hundreds of thousands of cells from morbidly obese individuals undergoing weight loss surgery. They found a range of positive effects, including clearing out damaged, aging cells and increased metabolism of harmful fats.
    • The team, headed by William R Scott, PhD, at the MRC Laboratory of Medical Sciences and at Imperial College London, analyzed gene expression in more than 170,000 cells that made up the fat tissue samples from 70 people. They generated a high-resolution single-nucleus and spatial atlas of human AT in people with extreme obesity undergoing therapeutic weight loss and in healthy lean counterparts. The investigators suggest that their findings could help scientists better understand how weight loss leads to health improvements at a molecular level, which in the future could help to inform the development of therapies for diseases such as type 2 diabetes.
    • “We’ve known for a long time that weight loss is one of the best ways to treat the complications of obesity, such as diabetes, but we haven’t fully understood why,” Scott said. “This study provides a detailed map of what may actually be driving some of these health benefits at a tissue and cellular level.”
    • “Scott and colleagues reported on the study in Nature, in a paper titled “Selective remodeling of the adipose niche in obesity and weight loss,” in which they stated, “This rich representation of human AT biology and pathophysiology offers a valuable resource for mechanistic and therapeutic exploration.”
  • The New York Times considers “Just How Harmful Is Vaping? More Evidence Is Emerging. A new study that found high levels of heavy metals in popular nicotine vapes adds to concerns about the products.”
  • Per Fierce Pharma,
    • “Pfizer and Astellas are underlining the benefits of Xtandi as part of a combination therapy for certain patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with an overall survival win.
    • “The new data come from the companies’ phase 3 Embark study, which in 2023 led to the FDA approval of Xtandi in patients with nmHSPC with biochemical recurrence (BCR) at high risk of metastasis.
    • “In the trial, Xtandi was studied as a single agent and in combination with leuprolide against placebo and leuprolide. For the trial’s primary endpoint, the Xtandi combo delivered a statistically significant improvement in metastasis-free survival compared with placebo and leuprolide.
    • “At the time, the trial’s overall survival data were mature.
    • “Now, Xtandi plus leuprolide has proved it can, in fact, extend the lives of these patients, demonstrating a “statistically significant and clinically meaningful improvement” in overall survival, Pfizer announced in a July 10 press release.”

From the U.S. healthcare business front,

  • The WTW consulting firm discusses how to strategically manage health and wellness costs in 2025.
  • Healthcare Dive reports,
    • “UnitedHealth has tapped longtime insurance executive Mike Cotton to lead its Medicaid business, filling a role that has stood empty since the company reshuffled its executive team earlier this year, the company confirmed to Healthcare Dive.
    • “Meanwhile, Bobby Hunter, who leads the healthcare juggernaut’s Medicare division, is stepping up as CEO of government programs, with oversight of both Medicare and Medicaid.”
  • Fierce Healthcare notes,
    • “Health Care Service Corporation is launching the HealthSpring brand for its Medicare products after closing the deal to acquire Cigna’s Medicare plans.
    • “Plans under the HealthSpring label were included in the deal, and HCSC said in an announcement that it refreshed the brand identity for a national rollout. The insurer will offer its first plans under the HealthSpring umbrella later this year, pending needed regulatory approvals.”
  • Fierce Biotech informs us,
    • “AbbVie is paying Ichnos Glenmark Innovation (IGI) $700 million upfront for a next-generation rival to Johnson & Johnson’s Tecvayli, positioning the Big Pharma to advance a new option for multiple myeloma patients.
    • “The deal gives AbbVie rights to ISB 2001, a trispecific antibody that targets CD38, BCMA and CD3. J&J’s Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic hit BCMA and CD3. Adding CD38 to the mix could boost binding to tumor cells with low expression of BCMA and stop cancers from becoming resistant by downregulating the antigens.
    • “AbbVie has placed a high price on that potential, coughing up $700 million for a phase 1 candidate and offering up to $1.225 billion in development regulatory, and commercial milestones. In return, IGI has granted AbbVie rights to the trispecific across North America, Europe, Japan and Greater China.”

Weekend update

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

From Washington, DC

  • Roll Call tells us what actions the Houses of Congress are expected to take this week.
  • The Supreme Court begins the last month of its October 2024 term this week. The Court plans to release new opinions on Thursday. SCOTUSblog keeps track of the Court’s decisions here.
  • The Trump Administration released its detailed FY 2026 budget proposal last Friday. The proposal includes the three traditional FEHB / PSHB appropriations provisions
    • The contraceptive coverage mandate (Sec. 721)
    • The abortion coverage restriction / Hyde amendment (Secs. 611, 612)
    • The prohibition on application of full Cost Accounting Standard coverage to FEHB carriers (Sec. 609)
  • The proposal adds the following new provision (Sec. 743)
    • “None of the funds made available by this Act or any other Act may be provided for insurance plans in the Federal Employees Health Benefits program to cover the cost of surgical procedures or puberty blockers or hormone therapy for the purpose of gender affirming care.”
  • Govexec adds,
    • The proposal [Sec. 743] comes just a week after House Republicans made a late change to their budget reconciliation package, which initially would have barred Medicaid or CHIP funds going toward pediatric gender affirming care, to ban federal funds going to those treatments for adults as well.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has granted an approval to Moderna’s next-generation COVID-19 vaccine, but with limits that will restrict use to older adults and people with preexisting health conditions. The OK is the first since agency leadership rolled out new guidelines for COVID shot approvals.
    • The new vaccine, which Moderna will sell as mNexspike, is cleared for healthy adults 65 years and older and for individuals aged between 12 years and 64 years with one or more underlying “risk factors,” the company said Saturday.

From the judicial front,

  • Govexec tells us,
    • “An appeals court has allowed a pause on all layoffs at most major federal agencies to remain in place, rejecting the Trump administration’s bid to block a lower court’s injunction and likely sending the matter to the Supreme Court for final adjudication. 
    • “A ruling preventing most reductions in force and agency reorganizations from taking place will continue indefinitely after the U.S. Court of Appeals for the Ninth Circuit ruled—in a 2-1 decision—in favor of the unions, municipalities and advocacy groups that sued over the workforce reduction plans. The Trump administration brought the case on an emergency basis, seeking a stay of a district court ruling that had found President Trump likely acted outside his legal and constitutional powers.”
    • Here’s a link to the Court’s opinion.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “When facing down a cancer diagnosis, patients often ask: What can I do to help my own odds? 
    • “The answer, data increasingly shows, is to go back to the basics: exercise and a good diet. 
    • “A structured exercise program with a trainer helped colorectal cancer patients lower their risks of death and cancer recurrence after treatment, according to a study released Sunday at the American Society of Clinical Oncology’s annual conference in Chicago and published in the New England Journal of Medicine. 
    • “The study spanned more than a decade and is the first to answer conclusively in a controlled trial whether physical activity can improve cancer-related survival, the study’s authors said. Patients in the program had a 37% lower risk of death after eight years, compared with patients who only received educational information on exercise.”
  • The New York Times informs us,
    • “Breast cancer patients whose tumors have spread to other parts of their bodies live from scan to scan. Is their treatment working? Or will they learn their cancer is growing again?
    • “But a new study sponsored by the drug company AstraZeneca showed that there is an alternative: Instead of waiting for a scan to show that a cancer is growing, it’s possible to find early signs that the cancer is resisting the drugs that were controlling it.
    • “To do that, researchers used a blood test to find mutations in cancer cells that let the tumors defy standard treatments. Early detection allowed patients to be switched to a different drug that overcomes the mutated cancer. The result was to keep the cancers in check longer and allow patients to have more than an extra year without deteriorating quality of life.
    • “The study was reported Sunday at the annual meeting of the American Society of Clinical Oncology (ASCO) and published in The New England Journal of Medicine.”
  • Also from ASCO, Biopharma Dive relates,
    • “AstraZeneca and Daiichi Sankyo’s targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced gastric cancer live longer than those who received a commonly prescribed, two-drug regimen involving chemotherapy.
    • “The finding, detailed Saturday at the American Society of Clinical Oncology’s annual meeting, gives physicians a clearer choice for when patients’ disease progresses after initial treatment.
    • “Data from the trial should also shore up AstraZeneca and Daiichi’s market position. Enhertu already won Food and Drug Administration approval for gastric cancer that’s positive for a protein called HER2 following first-line treatment with Herceptin, an older HER2-targeting medicine.”
  • The Washington Post lets us know about “four ways women are physically stronger than men. Strength is associated with brute force, but female bodies excel in resilience and other key areas.”
  • The New York Times Well suggests ten workouts that you can take on vacation.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “Could you use some discreet help with birth control from a $14.99-a-month period-tracking app?
    • “How about a hands-free, wearable breast pump, for $549; a $299 wristband to soothe hot flashes; or an extra-slim, temperature-neutral, LED-lit speculum to bring to gynecologists’ appointments — part of a $125 kit including “comfy socks”?
    • “These products and more are part of a fast-growing industry known as “femtech” — high-tech solutions for women’s health needs — whose many female founders say they’re tackling age-old inequities.
    • “Investors have jumped in, growing the market from $40.2 billion in 2020 to a projected $75 billion this year. And that’s just for starters: A “ghost market” of strategies to address “profoundly underserved women’s health needs” could reap up to $360 billion, a venture capital firm reported in March.
    • “Many areas of women’s health — like menstrual pain, endometriosis, polycystic ovarian syndrome, preeclampsia, and menopause — have been overlooked for so long by traditional medicine that women have had to take these problems into their own hands and innovate,” said Elizabeth Gazda, CEO of Embr Labs, which makes the wristband to treat hot flashes. “And because these innovations are occurring at a time of expanding technological ability, with cloud computing and ubiquitous smartphone adoption, women’s health is now leapfrogging men’s health.”
  • In the same vein, Fortune Well interviews Midi Health’s CEO Joanne Strober.
    • The menopause care company, launched in 2021, has helped 200,000 women get support and care to manage menopause and is the fastest-growing virtual health care company for women in midlife. But CEO Joanna Strober admits that many women left their appointments wanting more guidance: How much fiber should I be eating? What’s the proper combination of melatonin and magnesium to improve sleep? How do I prevent cognitive decline?
    • Now, Strober hopes to give them an answer—and appeal to younger women. 
    • In an exclusive interview with Fortune, Strober shared the expansion plans for Midi Health with the launch of AgeWell, which she calls a “longevity roadmap grounded in women’s hormonal health” to improve women’s “strength” and “vitality.” 

Friday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NCQA, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash
  • The University of Minnesota’s CIDRAP tells us,
    • “The Centers for Disease Control and Prevention (CDC) yesterday updated its childhood immunization schedule with a revised recommendation on COVID-19 vaccines for healthy children.
    • “The changes partly reflect a new position on COVID vaccine recommendations for healthy children announced earlier in the week by Department of Health and Human Services Secretary Robert F. Kennedy Jr., though they do not go as far as Kennedy had suggested.
    • “The CDC childhood immunization schedule now says that healthy children ages 6 months to 17 years, when the parent expresses a desire for their child to vaccinated, “may receive COVID-19 vaccination, informed by the clinical judgement of a healthcare provider and personal preference and circumstances.” Previously, the agency had recommended COVID-19 vaccines for healthy children ages 6 months and older, based on the recommendation of the CDC’s Advisory Committee on Immunization Practices.” * * *
    • “[A]ccording to the CDC, shared clinical decision-making recommendations on the immunization schedule are required to be covered by private insurers [with no cost sharing when provided in-network] under the Affordable Care Act.
    • “The CDC is still recommending COVID vaccination for children ages 6 months to 17 years who are moderately or severely immunocompromised.”
  • Govexec informs us,
    • “The White House on Friday told the government’s top watchdog it will only cooperate when doing so does not impede its ability to carry out President Trump’s agenda, reigniting a feud that traces back to the president’s first term in office. 
    • “The letter, from Office of Management and Budget General Counsel Mark Paoletta to the Government Accountability Office, follows the watchdog last week finding the Trump administration violated federal spending laws by withholding money appropriated by Congress. Paoletta denied that the administration has flouted the Impoundment Control Act, the law that prohibits the executive branch from withholding congressionally appropriated funds for policy reasons. 
    • “The OMB official criticized GAO for asking too many questions of the White House, including the dozens of probes the watchdog has opened into potential illegal impoundments. Paoletta noted that GAO has around 50 “open engagements” with the budget office. 
    • “Not only does GAO exceed its statutory authority when it unhelpfully injects itself into an agency’s implementation of a program, GAO also hampers the Executive Branch’s ability to carry out its statutory mandates,” Paoletta said in the letter, which was first reported by The Washington Post. He added the legislative branch agency often attempts to substitute its “policy views for those of the president.” 
  • The American Medical Association News lets us know,
    • “The Government Accountability Office May 29 released a report recommending the Centers for Medicare & Medicaid Services target behavioral health services when auditing Medicare Advantage plans’ use of prior authorization. CMS said it currently does not target behavioral health services because they make up a small percentage of MA services, the report said.     
    • “The report describes selected MA organizations’ prior authorization requirements and use of internal coverage criteria for prior authorization decisions on behavioral health services. It also examines CMS’ oversight of the use of internal coverage criteria, among other issues. GAO said that CMS “would take the recommendation under advisement in the future.” 

In Food and Drug Administration news,

  • Per Healio,
    • “The FDA approved Tryptyr to treat the signs and symptoms of dry eye disease, according to a press release from Alcon.” * * *
    • “Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” Marjan Farid, MD, professor of ophthalmology at the University of California, Irvine, said in the release. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.” * * *
    • “Alcon expects a third quarter launch for Tryptyr in the U.S.”
  • Per HCPLive,
    • “The US Food and Drug Administration (FDA) has approved hydrocortisone (KHINDIVI) oral solution as a replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency.1
    • “Announced by Eton Pharmaceuticals on May 28, 2025, this approval marked the first FDA-approved oral solution formulation of hydrocortisone, designed to address administration and dosing accuracy in patients who may have difficulty swallowing pills or special administration needs.” * * *
    • “Adrenal insufficiency is a rare, serious condition characterized by decreased production of aldosterone and cortisol due to reduced adrenal gland function. It can present acutely in an adrenal crisis or chronically, and if not recognized, can lead to very high morbidity and mortality.2 In the release, Eton Pharmaceuticals estimated that more than 5,000 adrenal insufficiency patients are present in the US between the ages of 5 and 17.”

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.
    • COVID-19
      • COVID-19 wastewater activity, emergency department visits, and laboratory percent positivity are at very low levels.
      • 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.
  • The University of Minnesota’s CIDRAP adds,
    • “The US Centers for Disease Control and Prevention (CDC) in its weekly update today reported 42 measles cases, some tied to a large outbreak centered in West Texas and others linked to instances of community transmission or travel to other states or countries, lifting the nation’s total to 1,088 infections.
    • “Two more states reported their first cases this week, Iowa and Nebraska, putting the number of affected jurisdictions at 33. The number of outbreaks remained at 14, and 90% of cases are linked to outbreaks.” * * *
    • “The Texas Department of State Health Services (TDSHS) today reported 9 more cases in the West Texas outbreak, putting the total since January at 738. Though 35 counties have reported cases linked to the outbreak, only 7 still have ongoing transmission. 
    • “Like other states, Texas also continues to record measles cases from various sources that apparently aren’t linked to the larger outbreak, and today officials reported 8 more such infections, lifting that total to 32. 
    • “A few other states have reported cases linked to West Texas activity, but no new illnesses were reported in New Mexico or Oklahoma. On May 28, Kansas reported a total of 64 cases from 11 counties, 59 of them linked to an outbreak in the southwestern part of the state.’
  • CBS News reports,
    • “Hormel Foods Corporation is recalling over 256,000 pounds of canned beef stew nationwide due to potential contamination with wood fragments, according to federal health officials.
    • “In a recall notice posted Wednesday [May 28], the U.S. Department of Agriculture’s Food Safety and Inspection Service said the 20-oz. metal cans containing “Dinty Moore Beef Stew” were shipped to retail locations nationwide.
    • “The recalled products have a “FEB 2028” best by date, lot code “T02045” and establishment number “EST 199G” printed on the can. 
    • “The problem was discovered after the establishment notified FSIS that they had received three consumer complaints reporting pieces of wood in the beef stew product,” the notice read. 
    • “So far, there have been no confirmed reports of injury.”
  • The American Medical Association lets us know “what doctors wish patients knew about improving eye health.”
  • Health Day points out,
    • “Among U.S. youth, overdose deaths attributable to synthetic opioids alone are increasingly predominant, according to a study published online May 20 in Pediatrics.
    • “Megan Miller, M.P.H., from the New York University Grossman School of Medicine in New York City, and colleagues examined trends in overdose deaths involving combinations of synthetic opioids with benzodiazepine, cocaine, heroin, prescription opioids, and other stimulants. Findings were based on U.S. youth aged 15 to 24 years from 2018 to 2022 using the National Vital Statistics System multiple cause of death datasets.
    • “The researchers found that between 2018 and 2022, overdose death counts increased from 4,652 to 6,723 (10.85 to 15.16 per 100,000), with a slight decrease between 2021 and 2022. Deaths involving synthetic opioids only showed the largest increases (1.8 to 4.8 deaths per 100,000). Regardless of race, ethnicity, or sex, fatal synthetic opioid-only overdose rates were higher than polydrug overdose rates involving synthetic opioids since 2020. In 2022, rates of synthetic-only overdose deaths were 2.49- and 2.15-times higher among male versus female youth and among those aged 20 to 24 versus 15 to 19 years, respectively.”
  • and
    • “Heart disease, strokes and diabetes contribute to many dementia cases in the United States, but the risk is not equal everywhere, a new study says.
    • “Overall, more than a third (37%) of U.S. dementia cases are linked to eight conditions: diabetes, heart failure, atrial fibrillation, coronary artery disease, heart attack, stroke, high blood pressure and high cholesterol, researchers found.
    • “The South has the strongest link between these diseases and dementia, researchers reported recently in the journal Alzheimer’s & Dementia.
    • “A substantial number of dementia cases could be eliminated by mitigating modifiable cardiometabolic risk factors, especially in U.S. counties with a high risk of dementia attributed to these risk factors,” senior researcher Dr. Brad Racette said in a news release. He’s chair of neurology at Barrow Neurological Institute in Phoenix.”
  • Per a National Institutes of Health news release,
    • “A research team funded by the National Institutes of Health (NIH) has identified a diagnostic aid that has the potential to accurately predict the recurrence of diabetic foot ulcers that appear to be fully healed. By measuring the skin’s barrier function through a process known as trans-epidermal water loss, or TEWL, scientists were able to determine which wounds were more likely to reopen. TEWL measurements are a major factor in burn care, where deep layers of the skin are often damaged. The findings suggest that full restoration of skin barrier function should be incorporated into existing wound treatment standards to ensure complete wound closure and to better identify patients at risk of wound recurrence.
    • “This study is an important initial step to give clinicians treating diabetic foot ulcers a reliable diagnostic aid for the first time to assess an individual’s risk of ulcer recurrence,” said Teresa Jones, M.D. program director for the Division of Diabetes, Endocrinology, & Metabolic Diseases at NIH’s National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK). “Foot ulcers are such a confounding issue with diabetes and being able to determine which wounds are at highest risk for recurrence could save many lives and limbs.”  
  • NCQA, writing in LinkedIn, tells us,
    • The use of peer support is a growing trend for populations affected by mental health and substance use disorders. Peers—both paid and volunteer—have many of the same lived experiences as the people they serve, and can help them navigate the health care system, access treatment and overcome barriers to recovery.
    • Peers are another avenue of support in the behavioral care system—their shared experience related to mental health, addiction and recovery helps them build trust relationships. Many studies show the benefits of peer support: decreased days in inpatient care, increased engagement in outpatient treatment, reduced readmission rates and lower relapse rates.
    • “There’s a stigma associated with receiving mental health and substance use treatment,” says Chrissy Craig, MSPH, NCQA’s Senior Health Care Analyst. “Because of their lived experience, peers can connect with people who may not be ready to engage in traditional treatment approaches. They can build trust and encourage individuals to get the help they need.”
    • Recognizing the importance of peer support, NCQA has added it as an option for follow-up care in four HEDIS® measures:
      • Follow-Up After Emergency Department Visit for Substance Use (FUA).
      • Follow-Up After Hospitalization for Mental Illness (FUH).
      • Follow-Up After Emergency Department Visit for Mental Illness (FUM).
      • Follow-Up After High-Intensity Care for Substance Use Disorder (FUI) (MY 2026).
  • Per Health Leaders Media,
    • “An AI tool that can detect inflammation in the coronary artery could help clinicians diagnose heart disease much earlier, even decades before the patient shows any outward signs of distress.
    • “CaRi-Heart Technology, developed by Connecticut-based Caristo Diagnostics, was recently given its own Category III CPT code by the American Medical Association’s CPT Editorial Panel, an important step in the path to adoption after FDA approval and, just as important, payer reimbursement. The technology has also shown promising results in trials conducted in 2024 at five National Health Service hospitals in the UK, where reports indicate more than half of patients analyzed by the AI tool had their treatments changed.
    • “To clinicians, the tool could be a critical step forward in the diagnosis and treatment of heart disease, the leading cause of death in the country.”
  • The Wall Street Journal reports,
    • “Sanofi and Regeneron’s respiratory drug, itepekimab, showed mixed results in late-stage trials for COPD.
    • “One trial saw a statistically significant 27% reduction, while the other missed its primary goal with only a 2% reduction.
    • “Sanofi shares fell 7% and Regeneron shares dropped 12% after the results; future steps will be discussed with regulators.”
  • Per BioPharma Dive,
    • “A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn’t extend survival, complicating its potential path to approval in the U.S.
    • “When administered alongside chemotherapy, the drug, known as ivonescimab, reduced the risk of death or disease progression by 48% compared to chemotherapy alone in patients whose non-small cell lung cancer has a mutation in a gene called EGFR. However, a 21% reduction in death risk, specifically, didn’t meet the threshold for statistical significance, Summit said in a statement Friday.
    • “Summit intends to seek Food and Drug Administration approval based on the study results. Yet in its statement, the company indicated the timing of a filing is uncertain given the agency has made clear that a survival benefit is “necessary” to support a submission.”

Fromm the U.S. healthcare business front,

  • The actuarial consulting firm, Milliman, announced on May 27,
    • the release of the 2025 Milliman Medical Index (MMI), which measures healthcare costs for Americans covered by a typical employer-sponsored health insurance plan. Healthcare costs for the average person increased 6.7% in 2025, with pharmacy costs increasing by 9.7% and outpatient facility care costs rising 8.5%. Healthcare costs for a hypothetical family of four rose to $35,119.
    • “Pharmaceutical costs have been a leading driver of healthcare spending in recent years,” says Milliman Principal and Consulting Actuary Dave Liner. “This year, outpatient facility services and pharmacy costs together accounted for nearly 70% of the total cost increase. Much of the outpatient growth is linked to high-cost drugs administered in outpatient settings.”
    • In recognition of the MMI’s 20th anniversary, this edition includes a look back at how healthcare costs have evolved in the last 20 years. “Since we began publishing the MMI 20 years ago, healthcare costs for American families have nearly tripled,” says Milliman Principal and Consulting Actuary Deana Bell. “Annual growth has averaged 6.1%, far outpacing any other household expense. No other cost category has risen as steeply or as consistently over the past two decades. Outpatient facility care saw the largest increase of any category, rising 286% since 2005, reflecting the growing complexity of procedures now handled outside of inpatient settings.”
    • Read this year’s MMI.
  • An essayist writing in the Wall Street Journal, opines “America’s hospital-bed shortage is about to become a crisis. As new construction declines and occupancy rates soar, experts warn that hospitals may soon cease to function properly because of overcrowding.”
  • Modern Healthcare reports,
    • “Health systems, accountable care organizations and others are bringing extra staff and tracking technology into post-acute care to reduce hospital readmissions.
    • “Health systems, such as OSF Healthcare, and accountable care organizations, such as Provider Partners Connect Care are using remote patient monitoring equipment, electronic medical records software and additional staff to ensure patients don’t have a set-back that will send them back to the hospital. Readmissions add costs that ripple through the healthcare system and the Centers for Medicare and Medicaid Services penalizes hospitals and nursing homes for higher-than-predicted readmissions within 30 days of a hospital discharge.”
  • and
    • “UnityPoint Health, based in West Des Moines, Iowa, and MercyOne Siouxland Medical Center in Sioux City, Iowa, have signed a letter of intent for UnityPoint to acquire the medical center. The proposed agreement includes the hospital, its associated facilities, physician practices and home care services. The acquisition is expected to be finalized this summer, pending customary closing conditions.”
  • and
    • MDaudit, a cloud-based continuous risk monitoring platform that helps healthcare organizations reduce billing vulnerabilities and increase revenue, has entered into a definitive merger agreement to acquire Streamline Health Solutions, a provider of tools that help healthcare providers improve financial performance. The all-cash transaction is valued at approximately $37.4 million, including debt. The deal is expected to close in the third quarter.
  • Per Fierce Healthcare,
    • Women’s healthcare company Wisp has launched a diagnostics arm to offer low-cost testing at home for sexual and reproductive health, the company announced May 28. 
    • Wisp is an online platform that prescribes medication for a range of women’s health needs such as oral contraception, yeast infections, fertility, emergency contraception and some medication abortion. Women can pick up their prescriptions at the pharmacy on the same day as their request, following approval by a provider. Wisp also ships medications in discreet packaging. 
    • Wisp will now offer at-home tests for common sexually transmitted infections and free telehealth consultations for positive results, according to a release by the company. Patients will send completed urine tests or swabs to a partnered CLIA/CAP accredited laboratory and receive results in three to five business days. 
    • “The new model expands on Wisp’s direct-to-consumer telehealth platform and eliminates the need for patients to visit an in-person clinic to complete diagnostic testing. Patients can collect samples at home with tests sent in discreet packaging to maintain privacy in their healthcare and receive services entirely from home.”
  • and
    • “Talkspace inked a partnership with Amazon Pharmacy to streamline psychiatric medication fulfillment and home delivery for its members.
    • “It marks the first time a virtual behavioral health solution has integrated with Amazon Pharmacy, the companies said.
    • “Psychiatric patients of Talkspace can now have their medications fulfilled through Amazon Pharmacy and delivered to their homes for seamless medication management. Talkspace and Amazon Pharmacy tout the partnership will improve medication adherence for Talkspace members.” 
  • Per Healthcare Dive,
    • Best Buy reported $109 million in charges primarily linked to restructuring at the electronics retailer’s health unit in its first quarter, the company said in earnings released Thursday. 
    • The company began restructuring its health business after it recorded a non-cash goodwill impairment charge of $475 million in its fourth quarter ended Feb. 1, linked to a downward revision in the long-term financial projections for its health segment. 
    • The retailer partners with healthcare organizations to provide in-home health services, but the business has taken “longer to develop than we initially thought,” as providers grapple with financial challenges and the future of the federal government’s hospital at home waiver seems uncertain, Best Buy CEO Corie Barry said during a call with investors Thursday.

Thursday Report

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

From Washington, DC

  • The Wall Street Journal reports,
    • President Trump’s “big, beautiful bill” squeezed through the House after a late scramble to get rival factions on board. Next it goes to the Senate, where GOP lawmakers are already making demands and party leaders will once again need to bridge sharp disagreements.
    • The more than 1,000-page bill passed the House early Thursday morning after Speaker Mike Johnson (R., La.) found a recipe that satisfied just enough lawmakers, who approved the measure by just one vote after an all-night session. Now Senate Republican leader John Thune (R., S.D.) needs to line up enough support within his own narrow majority—without making changes that fracture the fragile House agreement and derail the party’s hopes to finish the bill by its July 4 target.
  • Federal News Network explains,
    • “Four of the six provisions on federal benefits cuts that originated from Republicans on the House Oversight and Government Reform Committee remain in the House-passed version of the bill, which now heads to the Senate for consideration. But notably, the proposed change to a “high-5” annuity calculation is no longer on the table. The provision was struck from the reconciliation legislation prior to the House’s passage of the bill.
    • “Oversight committee Democrats, as well as Rep. Mike Turner (R-Ohio), led efforts to remove the “high-5” proposal from the reconciliation bill. Rep. Stephen Lynch (D-Mass.) proposed an amendment to strike the “high-5” provision, which was ultimately adopted.
  • Tammy Flanagan, writing in Govexec, answers frequently asked questions about federal retirement.
  • The American Hospital Association (AHA) News tells us,
    • “Food and Drug Administration Commissioner Marty Makary testified May 22 before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on the discretionary budget proposal for fiscal year 2026. The proposal includes $93.8 billion for the Department of Health and Human Services, which oversees the FDA. The allocation is a 26.2% reduction from the FY 2025 enacted level.”  
  • The House of Representatives and the Senate left Washington DC today for a weeklong District/State work break following Memorial Day next Monday. The Senate Majority Leader announced his plans to file additional cloture motions for Presidential nominees when the Senate returns to Capitol Hill on June 2. That list does not include the President nominee for OPM Director Scott Kupor.
  • The AHA News informs us,
    • “The White House May 22 released its Make America Healthy Again report that focuses on childhood chronic disease. The report highlights findings from the MAHA Commission related to poor diet, exposure to environmental chemicals, lack of physical activity, stress and overmedicalization. The report lists a series of recommendations and next steps for research, including studies on nutrition, lifestyle interventions and precision toxicology. In parallel, the commission will develop a strategy to be released in August.”
  • The Washington Post assesses the report here.
  • The AHA News adds,
    • “The Departments of Labor, Health and Human Services, and the Treasury May 22 released several new guidance documents and requests for information on price transparency, following the February executive orderon the same subject. As part of this package, CMS released new guidance on calculating the estimated allowed amount values in the hospital machine-readable files. Whenever possible, hospitals should use the average dollar amount received over the last 12-month period (or less, if the payment methodology was only used for part of the year), which should be derived from the electronic remittance data. If there is no historic data, hospitals should use the expected payment amount, encoded as a dollar figure. This replaces previous guidance which allowed hospitals to use a code of nine number nines to signify that there was not sufficient historic data for that item or service over the last year. CMS also released an RFI on hospital price transparency accuracy and completeness. Comments are due July 21. The AHA plans to submit comments.  
    • “The departments also released a FAQ document, announcing that a new standard format for the insurer machine-readable files will be released Oct. 1, 2025. The new format aims to reduce the file size of the insurer files by decreasing duplicative data. In addition, the departments issued an RFI on improving prescription drug price transparency as part of the Transparency in Coverage, or insurer transparency rule.”

From the Food and Drug Administration front,

  • Per BioPharma Dive,
    • “Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called JN.1 coronavirus strain for the upcoming fall and winter seasons, maintaining guidance they gave last year.
    • The advisory committee convened Thursday for the first time under the Trump administration, meeting two days after FDA leadership unveiled new guidelines for COVID vaccine approvals. All nine members of the panel voted in favor of targeting shots to the JN.1 family of variants.
    • The FDA doesn’t have to follow the panel’s advice but usually does.”
  • STAT News adds,
    • “In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA vaccines to widen the age range of boys and young men that their labels say are at risk for a rare side effect causing heart inflammation.
    • “The letters, first reported by CBS News, asked Moderna and partners Pfizer and BioNTech to make updates to safety information based on new studies of myocarditis or pericarditis or both after vaccination. Both reactions are rare and known to occur most often in young men within a week after the second shot in the two-dose Covid-19 vaccine regimen, according to the Centers for Disease Control and Prevention. Most cases were mild, causing no more than brief chest pain.”
  • Per MedTech Dive,
    • “Stryker has received 510(k) clearance for a minimally invasive back pain treatment, positioning it to challenge Boston Scientific for the market. 
    • “The Food and Drug Administration clearance, which Stryker disclosed Monday, covers the use of the OptaBlate basivertebral nerve ablation system to provide relief for low back pain.
    • “Stryker is entering a growing market. Boston Scientific’s rival device, which it acquired for $850 million upfront in 2023, “grew strong double digits” in the first quarter, CEO Mike Mahoney told investors in an April earnings call.”
  • Per Fierce Pharma,
    • “While GSK’s Nucala may not have earned the distinction of becoming the first FDA approved biologic for chronic obstructive pulmonary disease (COPD), the British drugmaker is confident its IL-5 antibody still has a major role to play in tackling the traditionally tough-to-treat respiratory condition.
    • “Now, following an unexpected delay earlier this month, the company has a fresh FDA green light to put its thesis to the test.
    • “The FDA on Thursday approved Nucala as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.” 
  • and
    • “In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to expand Talzenna into a broader prostate cancer population has failed to impress.
    • “Late Wednesday, eight outside experts on the FDA’s Oncologic Drugs Advisory Committee delivered a unanimous 8-to-0 ‘No’ vote on the question of whether Pfizer’s PARP inhibitor Talzenna has a favorable benefit-risk profile in metastatic castration-resistant prostate cancer (mCRPC) patients without homologous recombination repair (HRR) gene mutations.
    • “Patients without HRR mutations make up the majority of the mCRPC patient population at about 70%, according to briefing docs released ahead of the meeting.”

From the judicial front,

  • Healthcare Dive tells us,
    • “A bankruptcy judge on Wednesday approved Rite Aid’s pharmacy asset sales to a variety of buyers, including some of the bankrupt drugstore chain’s rivals.
    • “Financial details were not disclosed, and sale documents redacted purchase prices for Rite Aid’s assets, which went to retail pharmacy chains like CVS and Walgreens, along with grocers Albertsons, Kroger and Giant Eagle and other buyers.” * * *
    • “The liquidation is a growth opportunity for CVS, already the nation’s largest drugstore chain with more than 9,000 pharmacies. The Woonsocket, Rhode Island-based company purchased prescription files from 625 Rite Aid stores in 15 states and fully acquired 64 brick-and-mortar Rite Aid locations in Idaho, Oregon and Washington.”
  • The Associated Press reports,
    • “The Supreme Court’s conservative majority on Thursday declined to reinstate independent agency board members fired by President Donald Trump, endorsing a robust view of presidential power.” * * *
    • “The court’s action essentially extended an order Chief Justice John Roberts issued in April that had the effect of removing two board members who Trump fired from agencies that deal with labor issues, including one with a key role for federal workers as Trump aims to drastically downsize the workforce.
    • “Neither agency has enough appointed members to take final actions on issues before them, as Trump has not sought to appoint replacements.”
    • “The decision Thursday keeps on hold an appellate ruling that had temporarily reinstated Gwynne Wilcox to the National Labor Relations Board and Cathy Harris to the Merit Systems Protection Board.”
  • Bloomberg Law points out,
    • “A federal district court judge in California said she will likely extend a freeze on President Donald Trump’s plan to lay off thousands of federal workers, dealing another blow to his unprecedented overhaul of the federal workforce. 
    • “Judge Susan Illston of the US District Court for the Northern District of California at a Thursday hearing said she is inclined to grant a preliminary injunction halting the layoffs while the case proceeds, temporarily protecting the jobs of thousands of federal workers.” 

From the public health and medical research front,

  • NBC News reports,
    • “New data from Truveta, a health care and analytics company, shows that the percentage of 6-month-old babies in Texas getting their measles vaccination in April increased by more than 30 times the prior year’s average.
    • “That means parents aren’t just getting the vaccine early, they’re getting it as early as they can,” Nina Masters, a senior scientist at Truveta and part of the research team, said in an interview with NBC News.
    • “Typically, the MMR is given in two doses, around a child’s first birthday, and again around the time a child enters kindergarten, at age 4 or 5. One dose is 93% effective at preventing measles, according to the Centers for Disease Control and Prevention. A second dose increases protection to 97%.”
  • Per Fierce Pharma,
    • “Roche, hoping to carve out a standard-of-care spot for its PI3K inhibitor Itovebi, now has another leg to stand on with new evidence that shows the drug can extend the lives of certain patients with breast cancer.
    • “Adding Itovebi to Ibrance and Faslodex slashed the risk of death by 33% in patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer that has grown during or after hormone therapy treatment. The data, to be presented at the American Society of Clinical Oncology’s (ASCO’s) annual meeting, come from Roche’s pivotal phase 3 INAVO120 trial. 
    • “In the 325-patient study, Roche’s Itovebi triplet combination kept patients alive for a median of 34 months compared to 27 months for those who took a placebo along with Ibrance and Faslodex.”
  • and
    • “Roche’s plan to bolster Tecentriq’s position in small cell lung cancer with Jazz Pharmaceuticals’ Zepzelca has paid off. But the pair’s success leaves room for improvement for future contenders.
    • “Adding Zepzelca on top of Tecentriq as maintenance treatment of first-line extensive-stage small cell lung cancer (ES-SCLC) significantly reduced patients’ risk of death by 27% compared with Tecentriq alone, according to data from the phase 3 IMforte trial.
    • “Patients who received the combo lived a median 13.2 months, versus 10.6 for those who got Tecentriq alone. The results will be presented at the 2025 American Society of Clinical Oncology annual meeting.”
  • STAT News relates,
    • “Merus said Thursday that a combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has kept 79% of patients with newly diagnosed metastatic head and cancer alive for at least one year, according to a new analysis of a mid-stage clinical trial. 
    • “The survival data are only a snapshot. Merus, a Dutch biotech, will need to complete a larger, randomized study to prove more definitively that its drug can extend the lives of patients with head and neck cancer beyond the ability of current treatments. But for now, the preliminary survival results are encouraging and matched the expectations of investors.
    • “Merus released the new petosemtamab data ahead of a presentation next week at the annual meeting of the American Society of Clinical Oncology.”
  • Per BioPharma Dive, “AI tool could help doctors ID breast cancers vulnerable to Enhertu. Tumors with low- and ultra-low levels of a protein called HER2 are treatable with Enhertu, but harder to identify. New research shows AI can improve diagnosis.”
  • Per a National Institutes of Health news release,
    • “National Institutes of Health (NIH) scientists have developed a new surgical technique for implanting multiple tissue grafts in the eye’s retina. The findings in animals may help advance treatment options for dry age-related macular degeneration (AMD), which is a leading cause of vision loss among older Americans. A report about the technique published today in JCI Insight.
    • “In diseases such as AMD, the light-sensitive retina tissue at the back of the eye degenerates. Scientists are testing therapies for restoring damaged retinas with grafts of tissue grown in the lab from patient-derived stem cells. Until now, surgeons have only been able to place one graft in the retina, limiting the area that can be treated in patients, and as well as the ability to conduct side-by-side comparisons in animal models. Such comparisons are crucial for confirming that the tissue grafts are integrating with the retina and the underlying blood supply from a network of tiny blood vessels known as the choriocapillaris.
    • “For the technique, investigators designed a new surgical clamp that maintains eye pressure during the insertion of two tissue patches in immediate succession while minimizing damage to the surrounding tissue.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance companies initially declined to pay more than one dollar for every $10 providers submitted in claims last year, an increase from 2023.
    • “Payers in 2024 initially denied 11.8% of dollars associated with hospital-based claims, according to a report from consultant Kodiak Solutions. That compares with 11.53% of dollars denied in 2023.
    • “The company examined data from its revenue cycle analytics platform used by more than 2,100 hospitals and 300,000 physicians. It categorized any initial bill that commercial, Medicaid and Medicare insurers initially rejected, or requested more information for, as a denial.
    • “Insurers often overturned their initial denials and ended up paying nearly 97% of dollars requested, according to the report.”
  • Reuters informs us,
    • “Median annual list price for new drugs over $370,000 in 2024
    • “72% of new drugs in 2024 for orphan diseases
    • “Drugmakers emphasize value, offer savings programs amid rising list prices.”
  • The International Foundation for Employee Benefit Plans shares its survey of GLP-1 drug coverage and expenses among employer sponsored plans.
  • Fierce Pharma notes,
    • “It’s plainly apparent that Novo Nordisk has had May 22 circled its calendar since February, when the FDA began the countdown for compounders to stop selling their versions of semaglutide.
    • “Now that the day has come, the Danish drugmaker is capitalizing on the chance to steer more patients toward its branded offerings.
    • “Self-paying patients new to Wegovy can access a one-month supply of the obesity blockbuster for $199 through June 30, Novo announced on Thursday. After that, the drug will go for its standing price of $499 a month for cash-paying customers, which was discounted in March from a previous price tag of $650 per month.”
  • Fierce Healthcare relates,
    • “Shares of Hinge Health jumped 22% above the initial public offering price in the company’s New York Stock Exchange debut on Thursday, bringing its market capitalization to more than $3 billion.
    • “The physical therapy company’s stock opened at $39.25 on Thursday and closed at $37.56, up 17% from its $32 per share IPO price. Hinge Health’s IPO has been closely watched given the recent stagnation in the exit markets and signals a potential upswing in the public investor market.”
  • Becker Hospital Review announced,
    • “Northern Light Inland Hospital and its associated clinical services in Waterville, Maine, will officially close May 27, marking the end of operations for the facility that has been gradually winding down since the closure was announced earlier this year.
    • “The hospital’s emergency department will stop accepting new patients at 12 p.m. on May 27. All remaining clinical services will cease at 5 p.m. the same day, the health system said in a May 22 news release.”

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.”

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.” 

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.”