Tuesday report

Patient safety

Tuesday report

David Ermer–CMS, FDA, Generative AI, Medical / Rx research, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News adds,
    • “The Department of Health and Human Services Administration for Community Living has launched the first phase of its Health at Home Challenge, a competition to support community care networks that have partnered with health care providers supporting dually eligible Medicare and Medicaid beneficiaries. Each phase of the competition offers up to $2 million in prize funding for winning teams. The first phase, currently underway and continuing through July, will reward up to 10 teams for implementation strategies to scale comprehensive services that reach high numbers of dually eligible and near-dually eligible beneficiaries. The second phase will reward up to five teams for accelerating implementation of winning strategies from the previous phase. Phase three will reward up to three teams for demonstrating the scale and impact of the winning programs selected from phase two.”
  • Federal News Network reports,
    • “Federal employee workplace disputes are coming under more scrutiny from a top committee Republican who argues that agencies have an “excessive reliance” on reaching case settlements rather than pursuing litigation.
    • “House Oversight and Government Reform Committee Chairman James Comer (R-Ky.) is raising concerns over what he described as high numbers of “sue-and-settle” cases involving federal employees. He suggested that if agencies litigated more cases, they would likely win more often.
    • “Comer’s letter, sent this week to the Office of Personnel Management, cited Merit Systems Protection Board data from fiscal 2005 to fiscal 2015 that showed during that time, 68% of federal employee cases reached settlements. And out of cases that were litigated, more than 80% of agency adverse action decisions were upheld.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Food and Drug Administration Commissioner Marty Makary resigned Tuesday after months of policy fights with top officials in the Department of Health and Human Services and the White House.
    • “His departure became official after President Trump signed off last week on a plan to fire Makary, The Wall Street Journal previously reported. Makary offered his resignation, effective Tuesday.
    • “Everybody wants that job,” Trump said. “Marty is a terrific guy and he’s going to go on and lead a good life. He was having some difficulty.” He added on his Truth Social platform that Kyle Diamantas, the deputy commissioner for food, would take over leading the agency in an acting capacity.
    • “The president also posted a text message from Makary that included his resignation and a list of what he considered his accomplishments, such as reducing drug-review times. “It’s been the honor of a lifetime to serve as your FDA Commissioner. I am forever grateful,” Makary said.”
  • MedTech Dive reports,
    • “Artera has received Food and Drug Administration clearance for an artificial intelligence tool that predicts the likelihood of a certain form of breast cancer developing distant metastases.
    • “The clearance, which Artera disclosed Wednesday, covers technology that uses histopathology images and clinical variables to stratify patients into low- and high-risk groups.
    • “Insights into the risk of distant metastases could improve decisions about the use of treatments including chemotherapy, the company said.”
  • and
    • “Johns Hopkins University spinoff Bayesian Health received 510(k) clearance for an artificial intelligence tool to help detect sepsis early.
    • “Sepsis is a life threatening response to infection. Detecting sepsis earlier can improve a patient’s chance for survival. Once a clinician suspects sepsis, the clock has been running, often for hours or even days, Bayesian Health founder and CEO Suchi Saria said in a Tuesday statement.
    • “Other Food and Drug Administration-authorized sepsis tools on the market require a physician to suspect sepsis first. Bayesian’s system, which uses electronic health records and AI, can detect sepsis nearly two to 48 hours faster than traditional methods, the company said.”
  • The American Hospital Association notes,
    • “The Food and Drug Administration has identified a Class I recall of convenience kits by Aligned Medical Solutions that contain recalled Namic Angiographic Control Syringes by Medline.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “Alcohol is wreaking havoc on U.S. public health. American society looks the other way.”
    • “Confronting heavy drinking could be one of the best ways to improve health and save lives.”
    • * * * “Of 178,000 deaths that occur each year from alcohol, roughly one-third are from causes like car crashes and alcohol poisoning. The rest are from cancer, heart disease, liver failure, and other chronic conditions that result from sustained heavy drinking. As far as drugs are concerned, alcohol’s toll is only outpaced by the prolonged damage of tobacco. 
    • :But though the U.S. has dramatically cut tobacco use, it has never made a serious effort to curb alcohol-related harms other than in the infamous era of Prohibition. Over twice as many Americans consumed alcohol in 2024 than used tobacco products, federal estimates suggest.” * * *
    • “Recent polls suggest drinking levels have reached historic lows in the U.S., with about half of adults abstaining. Last year, while much of the alcohol industry struggled against new headwinds, the nonalcoholic sector grew. Companies launched alcohol-free products and shifted their marketing to align with health-conscious customers. 
    • “Strikingly, there is little evidence that the mocktail trend is driving actual health improvements, experts told STAT. That may be because of lagging data. Or it may reflect how in many cases, market research suggests drinkers are adding nonalcoholic beverages to their rotation, rather than switching over entirely. The groups that could most benefit from cutting back, including heavy drinkers, may not be interested at all.
    • “Meanwhile, heavy and binge drinking — practices known to be particularly harmful to health — have remained at pandemic levels among key groups, including older adults and teenagers. Five million underage people used alcohol in 2024, and over half of those 12 to 20 years old engaged in binge drinking, defined as four or more drinks in one sitting for women, or five for men.”  
  • MedPage Today relates,
    • “Despite improvements in survival, the incidence of stage IV breast cancer increased significantly from 2010 through 2021, according to a U.S. population-based cohort study.
    • “The age-adjusted incidence rate of de novo stage IV breast cancer significantly increased from 9.5 cases per 100,000 females in 2010 to 11.2 cases in 2021, an annual percentage change (APC) of 1.2% (95% CI 0.8-1.6), reported José P. Leone, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues.
    • “Among males, there was also a statistically significant increase in stage IV incidence, from 0.12 cases per 100,000 in 2010 to 0.20 cases in 2021, an APC of 3.7% (95% CI 1.0-6.5), they noted in JAMA Network Open.
    • “Moreover, the incidence of stage IV breast cancer increased significantly across age groups and numerically across all races and ethnicities.”
  • and
    • “Two non-pharmaceutical approaches for irritable bowel syndrome (IBS) feasibly offered patients symptom relief, according to research presented at the annual Digestive Disease Week meeting. 
    • “In a post-hoc analysis of a small single-arm trial, IBS patients’ mean scores on a 0-100 scale dropped from baseline for pain (37 to 21.6), discomfort (48.4 to 27.4), distention (54.8 to 30.9), and bloating (54.4 to 31.8) after 2 weeks of an oral, palatable elemental diet followed by a 2-week follow-up period, reported researchers led by Ali Rezaie, MD, of Cedars-Sinai Medical Center in Los Angeles.
    • “Even after reintroduction of a regular diet, “a 2-week elemental diet significantly improved abdominal pain and other IBS symptoms across subtypes using FDA-recommended responder endpoints,” Rezaie and colleagues wrote in their poster. “Larger, long-term studies are needed to confirm durability and understand how it works.”
    • “And in a sham-controlled randomized trial, people with IBS who used a virtual reality (VR) program to deliver cognitive behavioral therapy (CBT) reported greater symptom improvement after 8 weeks, with scores of 244.3 versus 295.6 with sham on a 0-500 scale where higher numbers indicate more severe symptoms (P=0.026), reported Christopher Almario, MD, of Cedars-Sinai Medical Center, and colleagues.”
  • Health Day informs us,
    • “About 8,500 steps a day may be the sweet spot for keeping weight off after dieting, new research shows.
    • “The findings — recently published in the International Journal of Environmental Research and Public Health — are also scheduled for presentation this week at the European Congress on Obesity in Istanbul.
    • “The most important — and greatest — challenge when treating obesity is preventing weight regain,” said lead researcher Marwan El Ghoch, a professor in biomedical, metabolic and neural sciences at the University of Modena and Reggio Emilia in Italy. 
    • “Around 80% of people with overweight or obesity who initially lose weight tend to put some or all of it back on again within three to five years,” he said. “The identification of a strategy that would solve this problem and help people maintain their new weight would be of huge clinical value.”
  • The Wall Street Journal lets us know,
    • “Novo Nordisk said certain patients on its higher-dose Wegovy shot lost 27.7% of their body weight on average in a trial.
    • “The Danish drugmaker said those patients who reacted faster to treatment by losing at least 15% of their weight after the first six months went on to achieve the nearly 28% total weight loss after about a year and a half.
    • “The company said the majority of the weight loss, around 84%, from using its Wegovy shots comes from losing body fat while preserving muscle function and improving muscle health.
    • “The data was presented at the European Congress on Obesity in Turkey.”
  • Cigna Health, writing in LinkedIn, discusses how employers can take advantage of Mental Health Awareness Month.
    • “Key Takeaways
      • “Offering mental health benefits is not enough—employees need a clear, guided path to find, understand, and use them.
      • “Benefits literacy is a productivity lever—clear navigation can reduce delays in care and protect vitality.
      • “Small design moves—one starting point, steady education—make the difference between availability and utilization.”
  • Fierce Healthcare considers “the broken pipeline of mental healthcare for LGBTQ teenagers.”
  • Beckers Hospital Review identifies the sixteen hospitals recognized by HealthGrades for deserving Outstanding Patient Experience, Patient Safety Excellence, and America’s Best Hospitals distinctions for 2026.
    • The organization evaluated 3,020 hospitals that submitted at least 100 patient experience surveys to CMS’ Hospital Consumer Assessment of Healthcare Providers and Systems between January and December 2024. Hospitals were evaluated on patient survey data on 10 patient experience measures. Recipients of the outstanding patient experience award earned the highest overall experience scores.
  • Fierce Pharma points out,
    • “Alkermes has chalked up a quick clinical win from its $2.37 billion acquisition of Avadel, reporting Tuesday that a phase 3 study of the sodium oxybate Lumryz met all primary and key secondary endpoints in a rare sleep disorder.
    • “The positive readout from the Revitalyz trial in idiopathic hypersomnia comes three months after Alkermes bagged Lumryz upon closing the Avadel buyout. By demonstrating its ability to significantly reduce daytime sleepiness and other symptoms, Lumryz is moving one step closer to helping Avadel investors realize the deal’s full value.”

From the U.S. healthcare business and artificial intelligence front,

  • Yesterday, the FEHBlog linked to a Modern Healthcare article about Optum Rx’s decision to implement a “new pharmacy care model that fundamentally changes how pharmacy benefits are priced and delivered — replacing traditional approaches tied to drug prices set by manufacturers or prescription volume with a transparent, fee‑based structure offered to every Optum Rx PBM customer. Here is a link to OptumRx’s news release about this decision.
  • Healthcare Dive adds,
    • “Employers are looking for a simpler pharmacy benefits model, particularly an approach that eliminates rebates to send savings directly to patients, according to a survey released last week.  
    • “More than 90% of employers surveyed agreed a rebate-free model would improve transparency into prescription drug prices, according to the research by communications and reputation management firm Penta Group for Evernorth Health Services, which operates the Express Scripts pharmacy benefit manager. 
    • “Additionally, 91% said an approach that removed rebates is easier to understand, and 90% reported it would improve employee satisfaction and drug affordability.” 
  • Fierce Healthcare relates,
    • “Providence’s turnaround efforts are continuing to gain steam, securing the 51-hospital nonprofit a $111 million net operating income (1.5% operating margin) for the start of 2026 and its third consecutive quarter on the right side of zero. 
    • “Financial performance numbers released Monday afternoon showed a roughly $360 million year-over-year operating improvement, when it had logged a -3.5% operating margin. Compared to then, Providence grew its operating revenues by 4.1%, to nearly $7.5 billion, while shrinking its operating expenses by 0.9%, to a bit over $7.3 billion. 
    • “The numbers, Providence said, reflect “deliberate steps” it’s taken over the past couple of years to reverse longstanding losses and generally tighten up the ship as financial headwinds, such as Medicaid funding cuts, loom for providers. 
    • “These, the West Coast system said in a release, include “streamlining its leadership structure, reducing duplication of services, renegotiating commercial payer contracts and sharpening its focus on core services—including transferring ownership or partnering with others on non‑core services.” 
  • Fierce Pharma tells us,
    • “Since Roche launched its long-acting eye disease medicine Vabysmo in 2022, Bayer and Regeneron have seen the impact on sales of their rival treatment Eylea, with the U.S. biotech taking a bigger hit.
    • “Bayer has managed to keep its annual Eylea sales relatively stable as they have toggled between 3.1 billion euros and 3.3 billion euros in each of the last four years. But that’s coming to an end this year as biosimilar competition is hitting the German company with full force.”
    • “In the first quarter (PDF), Bayer’s Eylea sales were down 24% year over year to 623 million euros ($731 million). They also declined sequentially by 11%. None of this is a surprise as Bayer has projected Eylea sales to drop 20% to 25% this year.”
    • “However, it wasn’t all bad news for Bayer’s Eylea franchise, as Chief Financial Officer Wolfgang Nickl cited “continued positive volume development” for Eylea’s longer-acting 8 mg formulation, which now accounts for 46% of the company’s overall Eylea sales.”
  • Beckers Health IT informs us,
    • “Cleveland Clinic’s quantum computing program has moved from a pilot phase to a fully operational “innovation engine” integrated with AI, according to Lara Jehi, MD, chief research information officer at the health system.
    • “It’s been a whirlwind, and we’ve made much more progress — and much faster — than we originally anticipated,” Dr. Jehi told Becker’s.
    • “Cleveland Clinic started its quantum computing journey in 2023 when the organization formed a 10-year partnership with IBM to create a joint accelerator center to advance healthcare discoveries using AI and cloud computing. As part of that deal, IBM installed its first private-sector, on-premise quantum computing system in the U.S. at Cleveland Clinic. The quantum computer, dubbed IBM’s Quantum System One, is dedicated to healthcare research and was installed at the Lerner Research Institute on Cleveland Clinic’s main campus.”

Monday report

David Ermer–CDC, CMS, Electronic health records, FDA, Federal employment benefits, Medicare, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. visited Ohio this week as part of his “Take Back Your Health” tour. He met with the CEOs of the Cleveland Clinic, University Hospitals, and MetroHealth—three of the nation’s leading health systems—following a tour of the Cleveland Clinic. He also visited a Head Start program, a regenerative farm, and an addiction recovery facility, spoke at the City Club of Cleveland, and spent an afternoon at Summa Health. The tour highlighted the Secretary’s commitment to a prevention-first approach to healthcare as the pathway to Make America Healthy Again.
    • “Across Ohio, I saw communities move beyond symptom management and confront the root causes of disease head-on,” said Secretary Kennedy. “From visiting local programs to meeting with the CEOs of the Cleveland Clinic, University Hospitals, MetroHealth, and Summa Health, we are aligning leaders at every level around a prevention-first approach to reverse the chronic disease epidemic and deliver on President Trump’s mandate to Make America Healthy Again.”

  • FedSmith points out,
    • “In late 2025, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for Contract Year 2027, outlining significant changes to Medicare Advantage (Part C) and the Medicare prescription drug program (Part D).
    • “While many federal retirees rely on FEHB coverage, Medicare decisions—especially around Part B and Part D—remain one of the most important and misunderstood planning areas. This proposed rule signals where Medicare is heading next—and what federal retirees should be watching now.”
    • The article explains these changes.
  • Federal News Network reports,
    • “Despite some hiring occurring across agencies, overall employment in the federal government is continuing to decline. That’s according to the latest jobs report from the Bureau of Labor Statistics. BLS reported that in April, federal employment numbers decreased by another 9,000 jobs. Since peaking in October 2024, the federal sector’s numbers are now down by 11.5%, or 348,000 jobs.” 
  • STAT News relates,
    • “Two years ago, my old pal Rachel Cohrs Zhang and I reported how Medicare’s actuaries predicted the new Alzheimer’s drug Leqembi would cost the program $3.5 billion in 2025. It turns out that prediction was way off.
    • “Through the first three quarters of 2025, Medicare spent $139 million on Leqembi (made by Eisai and Biogen) and $74 million on Kisunla (a newer one made by Eli Lilly), federal data show. Together, that equals $213 million across 19,000 patients, and would be around $280 million for the entire year — a small fraction of the original estimate. Uptake for the drugs has been so muted that Medicare is not forecasting significant spending on them in 2026 or 2027.
    • “Predicting the myriad health care needs for a pool of 70 million older adults and people with disabilities is not an easy task. But neurologists and policy experts told me the lower-than-expected spending lines up with the challenges that have faced the Alzheimer’s drugs since their approvals: The intravenous medications are not easy to administer and require a lot of imaging; the population of patients who are eligible is limited; and the drugs continue to have little meaningful benefits while carrying a risk of severe side effects like brain bleeding.
    • Read Bob Hermans’ new story to learn more
  • and
    • “Changes to the no surprise billing law’s controversial arbitration process could come at any moment. Doctors and other providers are getting a lot more face time with the federal officials writing the regulations, my colleague Tara Bannow reports in a new story.
    • “Health insurers say providers are abusing the system by ramming through high volumes of ineligible cases. Providers claim insurers are not paying up when they lose and don’t give enough information. Ultimately, providers are winning more than 80% of cases, getting arbitration awards that are three to nine times the in-network rates. 
    • Read Tara’s story to find out the lobbying pitches from R1, Radiology Partners, the Blues, and employer groups.”

From the Food and Drug Administration front,

  • Beckers Hospital Review tells us,
    • “The fate of FDA Commissioner Marty Makary, MD, remained unclear May 11 after multiple news outlets reported May 8 that President Donald Trump had signed off on a plan to oust him — reports the president publicly waved off the same day.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions. 
    • “Identifying potential new uses—such as a new indication or a new population—for FDA-approved drugs can help accelerate the availability of treatments by using existing knowledge about the drugs, including a drug’s safety profile. This request for public input is part of a broader FDA initiative to update the labeling of FDA-approved drugs, when supported by sufficient evidence, to ensure that information in the labeling is clinically meaningful for health care providers and patients and scientifically up to date.”
  • MedPage Today informs us,
    • “The FDA on Friday [May 8] issued guidance for manufacturers collecting postmarketing data on the safety of approved drugs and biologics in pregnancy, with the goal of better understanding potential risks for the pregnant patient and fetus.
    • “Currently many medical products may be recommended to pregnant women by healthcare providers in spite of the fact that data from the clinical trials used for FDA approval were insufficient to assess safety during pregnancy,” Tracy Beth Hoeg, MD, PhD, the agency’s top drug regulator, said in a press release “This guidance provides specific recommendations about how postmarketing data can be leveraged and studies can be designed so clinicians and the public can be better informed about product safety and pregnancy-related risks can be more promptly identified.”
  • NBC News reports,
    • “The Food and Drug Administration removed the black box warning from hormone replacement therapies late last year, and recently, the most insured type, the estrogen patch, has been in short supply amid a boom in the therapy’s popularity.
    • “it’s unclear when supplies will rebound. Meanwhile, there are other options for hormone replacement therapy.”
  • Fierce Pharma lets us know,
    • “Argenx is poised to expand the reach of its generalized myasthenia gravis (gMG) treatment Vyvgart and subcutaneous Vyvgart Hytrulo with an expanded FDA nod that covers a wider pool of disease serotypes. 
    • “The label expansion now covers “all serotypes of adult patients living with gMG,” including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive and triple seronegative gMG, argenx said. In the company’s phase 3 Adapt Seron study, the overall population of Vyvgart-treated patients experienced “rapid, significant and sustained improvements” in symptoms including speech, vision, physical function and other disease measures.” 
  • and
    • Roche’s intravenous-infused relapsing-remitting multiple sclerosis (RRMS) treatment Ocrevus scored a pediatric indication from the FDA, clearing the therapy for patients 10 and older and introducing a new treatment option to the underserved population. 
    • The agency based its approval on a clinical trial comparing Ocrevus to Novartis’ Gilenya (fingolimod), which was until now the only FDA-approved pediatric RRMS treatment. In the study, Ocrevus proved noninferiority to Gilenya in reducing patients’ annualized relapse rate and superiority in reducing new or enlarging T2 lesions and gadolinium-enhancing T2 lesions. 

From the public health and medical / Rx research front,

  • The Wall Street Journal shares what the Journal “knows about hantavirus drugs and vaccines in development.”
  • The New York Times reports,
    • “For about a decade, scientists have had remarkable success curing some blood cancers by modifying a patient’s own immune cells to recognize and kill the malignant cells.
    • “That same approach may help control H.I.V., among the wiliest of viruses, scientists will report on Tuesday. After a single infusion of immune cells engineered to recognize the virus, two people in a new study have suppressed their H.I.V. to undetectable levels, one of them for nearly two years.
    • “The data is scheduled to be presented at a gene therapy conferencein Boston, but the researchers shared an early copy with The New York Times.
    • “The treatment is years, if not decades, from being widely available, but the study offers what scientists call “proof of concept,” and the tantalizing hope that a single shot could one day offer lifelong relief from H.I.V.
    • “It is inspiration and a potential road map to get to where we need to go,” said Dr. Steve Deeks, an H.I.V. expert at the University of California, San Francisco, who led the trial.
    • “Other scientists were enthusiastic about the milestone.”
  • Radiology Business relates,
    • “Vigilance is needed to ensure patient safety in pediatric MR imaging, experts warn in new research published Friday by JACR. 
    • “Safety events remain relatively common in pediatric imaging, though most do not result in significant patient harm. However, these occurrences have the potential for serious consequences for patients, their parents or guardians, and MRI staff. 
    • ‘The conclusions are based on an analysis of safety data from five leading pediatric hospitals, spanning 2017 to 2022. Over the course of five years, there were about 146 pediatric MRI safety incidents that occurred, out of nearly 541,000 scans conducted. 
    • “Although uncommon, MRI safety incidents do occur in Zone IV of pediatric imaging departments,” corresponding author Jonathan R. Dillman MD, MSc, with the Department of Radiology at Cincinnati Children’s Hospital, and colleagues concluded. “While most cause no serious harm, their persistence and potential for catastrophic outcomes highlight the need for continued vigilance and ongoing safety improvements.”
    • “Zone 4 refers to the MRI scanner room, which presents the greatest risk of harm for both patients and staffers.” 
  • Med City News considers “Why We’re Still Finding Cancer Too Late>’
    • “The truth is there are ways to understand our cancer risk more precisely than we do today, and there are tools to manage it. What’s missing is awareness, access, and a system built to help us use these tools before something goes wrong.” * * *
    • “Healthcare innovators are shifting how we define and assess cancer risk, but education on evidence-based screening and risk-reduction practices needs to be front and center alongside these efforts so fewer people will ever have to say, “I wish I knew earlier.” Just like treatment options, prevention is not “one size fits all,” but a highly personalized approach. Individuals today can understand their risk of cancer far more clearly than any prior generation and, with the right information, resources, and support, can take powerful steps to reduce it. It won’t happen automatically. Our system is built to react to disease rather than anticipate it, which means personalized prevention rarely starts unless providers and patients help initiate it. 
    • “Instead of waiting for a cancer diagnosis, it’s time to ask the question: “What is this patient’s personal risk of cancer, and what can we do, starting now, to lower it and increase their chances of catching it early?”
  • A National Institutes of Health press release adds,
    • “Findings from a study supported in part by the National Institutes of Health (NIH) have identified a new model for predicting outcomes for hypertrophic cardiomyopathy (HCM), a heart condition with a prevalence of 1 in 500 people and a frequent cause of sudden cardiac death. Specifically, the findings demonstrate that incorporating prospective data including clinical history, imaging, and blood biomarker data into risk assessment can improve prediction of adverse cardiac events in people with HCM.
    • “The large, international study, called the Hypertrophic Cardiomyopathy Registry, was initially funded by NIH’s National Heart, Lung, and Blood Institute (NHLBI). The findings were published in JAMA.
    • “Current risk prediction guidelines for hypertrophic cardiomyopathy are imperfect, as they predict only sudden cardiac death, and not heart failure or other fatal and nonfatal cardiac adverse events,” said Christopher Kramer, M.D., a principal investigator of the study and cardiologist at the Heart and Vascular Center of the University of Virginia Health System. “This study is a major advance in that it provides evidence that incorporating these additional assessment methods better predicts risk of adverse outcomes.”
  • Health Day tells us,
    • “People hospitalized for opioid overdose have a higher rate of subsequent OD than previously thought, a new study says.
    • “Previously, it was estimated that about 6% of people who survived an opioid overdose wound up with a repeat overdose during the following year.
    • “But new results indicate that 21% experience a repeat OD after an emergency department visit for opioid overdose, researchers reported May 7 in the Journal of the American Medical Association.
    • “Patients’ risk of death also increased alongside their number of additional overdoses, the study found.
    • “Increased use of powerful synthetic opioids like fentanyl are fueling the rising risk of repeat overdose, researchers said.”
  • and
    • “Exposure therapy can successfully protect preschool children from peanut allergies, a new study says.
    • “Children ages 1 to 3 fed small amounts of peanut daily slowly became accustomed to them, researchers reported May 6 in The Lancet Regional Health Europe.
    • “All children who followed the protocol achieved the goal of eating three and a half peanuts without experiencing an allergic reaction, and most were able to consume up to 25 peanuts,” researcher Caroline Nilsson said in a news release. Nilsson is an associate professor of clinical science and education at the Karolinska Institute in Sweden.
    • “We consider the treatment to be safe if it is carried out under controlled conditions in a healthcare setting,” she said.”
  • MedPage Today points out,
    • “Human papillomavirus (HPV) vaccination rates varied substantially across and within U.S. regions, according to estimates in a retrospective, cross-sectional analysis, suggesting targeted interventions should focus on the needs of individual states.
    • “Comparing adolescents ages 13-17 years across the country against Alabama — where the 21% without at least one dose of the HPV vaccine approximates the national goal — several Northeast states did significantly better, including Rhode Island (adjusted OR 3.05, 95% CI 1.40-6.66), Massachusetts (aOR 2.19, 95% CI 1.24-3.88), and New Hampshire (aOR 1.72, 95% CI 1.03-2.88).
    • “Several Southern states significantly lagged Alabama in likelihood of HPV vaccination, including Mississippi (aOR 0.41, 95% CI 0.26-0.65), Georgia (aOR 0.45, 95% CI 0.27-0.76), Oklahoma (aOR 0.46, 95% CI 0.30-0.72), Kentucky (aOR 0.55, 95% CI 0.35-0.87), and West Virginia (aOR 0.56, 95% CI 0.36-0.87), reported Chinenye Lynette Ejezie, PhD, of Towson University in Maryland, and colleagues in a JAMA Pediatricsopens in a new tab or window research letter.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For decades, physicians and scientists have thought that metformin, a biguanide drug that is prescribed for millions of people worldwide for type 2 diabetes (T2D), mainly targets the liver to suppress glucose production. A Northwestern University-led study in mice has now found that this “wonder drug” instead acts primarily on the gut, and prevents glucose levels from rising in the blood by driving glucose utilization inside cells lining the intestine.
    • “The research found that metformin slows mitochondrial energy production in gut cells by inhibiting mitochondrial complex I in the intestinal epithelium. This then “co-opts” the intestines to function as a glucose sink, forcing the intestine to metabolize extra sugar. The study also found that another biguanide drug, phenformin, and the structurally unrelated supplement berberine, which is known as “nature’s Ozempic,” appear to engage the same pathway in the gut as does metformin.
    • “The preclinical findings could help to explain several gut-related clinical effects in people who take metformin and suggest that modulating mitochondrial metabolism in the gut may represent an effective strategy for controlling blood sugar. “Metformin essentially helps the intestine suck the glucose out of the bloodstream, which further highlights that the gut plays a major role in regulating blood sugar levels,” said corresponding author Navdeep Chandel, PhD, professor of biochemistry and molecular genetics at Northwestern University Feinberg School of Medicine.”

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente’s first-quarter operating performance took a step back in 2026 compared to the year prior, though investments and other sources of income picked up the slack to push the large integrated nonprofit’s bottom line past $2 billion. 
    • “The system reported operating income of $711 million for the quarter, or a 2.1% operating margin, in a Friday evening press release. It had logged $932 million in operating income, or a 2.9% operating margin, in the first three months of 2025.
    • “The organization’s performance came on the back of $34.6 billion in consolidated operating revenue, a roughly 8.7% year-over-year increase, and $33.9 billion of operating expenses, a 9.6% year-over-year increase.
    • “Though it grew in scale, Kaiser noted that it and its subsidiary Risant Health “continue to manage elevated costs in care delivery while taking steps to improve efficiency and maintain affordability.” 
  • and
    • “Omada Health reported revenue of $78 million in the first quarter, up 42% year over year as the company continues to expand its commercial reach and is seeing traction from its big investments in GLP-1 capabilities.
    • ‘The virtual chronic care provider reported strong adoption of its GLP-1 Care Track program while the company also continues to successfully sell multiple chronic condition programs to its existing customer base of employers and health plans, executives said during the company’s Q1 earnings call on Thursday.
    • “Q1 was the strongest first quarter in Omada’s history; on members, on revenue, on gross margin and on adjusted EBITDA,” Steven Cook, Omada Health’s chief financial officer, said during the earnings call. “Over the past year, we have been building capabilities to position Omada for durable growth, prescribing infrastructure, AI-empowered care delivery and an expanding set of GLP-1 and cardiometabolic solutions.”
  • Modern Healthcare relates,
    • “UnitedHealth Group Inc. said it will move away from having profits in its pharmacy benefits unit linked to the list prices of medications, the latest shift to address longstanding criticisms of its business model.
    • “Optum is UnitedHealth’s services arm. UnitedHealth’s Optum Rx unit helps determine which drugs are covered by health insurance plans, including UnitedHealthcare’s and others, and what prices patients must pay to access them. The company handled about 1.7 billion prescriptions last year.
    • “Optum Rx plans to shift to what a top executive called a more transparent fee structure that gives clients clarity into the money it gets from drugmakers. The way those details have been determined has been shrouded in secrecy, leading to claims that Optum Rx benefits from higher drug prices. The new approach is designed to refute those criticisms.” * * *
    • “We want our earnings based on service to the client,” Optum Chief Executive Officer Patrick Conway said in an interview. “We do not want any of those earnings tied to the list price of drugs, period.”
    • “The shift is expected to be complete by the end of next year, Conway said. It’s part of a series of changes the company is making to transform a business model that’s faced criticism from regulators, employers and lawmakers.”
  • The Wall Street Journal tells us,
    • “AstraZeneca is inching closer to its goal of reporting $80 billion in revenue by 2030 as the U.K. drugmaker pushes further into the U.S. and develops new oncology, rare disease and weight-loss drugs.
    • “The pharmaceutical giant has made progress on a pipeline of more than 25 medicines, each expected to generate more than $1 billion in revenue by the close of the decade, Chief Financial Officer Aradhana Sarin said. AstraZeneca hopes those drugs, along with new U.S. manufacturing investments and a direct listing of its shares in New York, will fuel growth.
    • “Revenue has been on the upswing since the company set its $80 billion target in 2024, with 2025 coming in at $58.74 billion. That was up from $45.81 billion in 2023, the year before it set the 2030 target.”
  • Beckers Health IT informs us,
    • “Whoop is rolling out new features to include virtual clinician visits and EHR integration.
    • The Boston-based fitness wearable company announced the updates May 8, positioning the new offerings as part of its broader shift from fitness and performance tracking toward clinical-grade health support, according to a Whoop news release.
    • “The new offerings include live, on-demand video consultations with licensed clinicians, which are expected to launch in the U.S. this summer. Whoop said the feature will allow members to connect with clinicians directly through the app, using months of biometric data, and when available, bloodwork and medical history, to provide a more comprehensive understanding of a member’s health.
    • “Whoop also announced plans to support electronic health record syncing through a partnership with HealthEx. The integration will allow members to access clinical information, including diagnoses, medications and procedures, directly within the app.”
  • Healthcare Dive notes,
    • “An influential group that advises Congress on Medicaid is recommending increasing transparency into artificial intelligence-backed prior authorization and boosting human oversight over automated pre-approvals for care. 
    • “The recommendations come as states and the federal government say they have limited insight into payers’ use of the technology in the safety-net insurance program, which can make it challenging for regulators to monitor for data bias or inaccuracies, analysts said during the meeting.”
  • Tech Target adds,
    • “The Workgroup for Electronic Data Interchange launched a free directory for organizations seeking testing partners for the CMS Advancing Interoperability and Improving Prior Authorization Final Rule (CMS-0057-F), in advance of the Jan. 1, 2027, compliance deadline. WEDI encouraged all organizations impacted by the rule to post their information on the directory and use it to test APIs with eligible partners.
    • “CMS-0057-F requires entities to implement certain HL7 FHIR APIs: Prior Authorization, Payer-to-Payer, Patient Access and Provider Access. The Prior Authorization API can identify documentation requirements for prior authorization approval, while the Payer-to-Payer API enables the exchange of claims and encounter data. The Patient Access API allows patients to access their health information, and the Provider Access API allows payers to share patient data with in-network providers.” * * *
    • “Organizations that want to test can complete a questionnaire that includes contact information, specific APIs available for testing and a link to their website. Organizations can also look for testing partners using the directory and contact the organizations they want to test with. The directory will display summaries of completed testing.
    • “At the time of publication, six entities had posted their information on the directory: Wellmark, Mayo Clinic, Veradigm, Blue Cross Blue Shield of Michigan, NextGen Healthcare and ZeOmega.”


Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network reports
    • “Nearly 12,000 new retirement claims entered the Office of Personnel Management’s systems last month. Coupled with OPM’s processing of about 17,000 retirement applications, the agency managed to reduce its inventory by several thousand claims. April was the first time OPM’s retirement backlog has dipped below 50,000 claims in more than five months. Currently, digital retirement claims are also being processed in about two-thirds the time of traditional paper applications.”
  • and
    • “Democrats are urging the Office of Personnel Management not to shut down the Combined Federal Campaign. In a letter to OPM this week, lawmakers warned that ending the CFC would be “disastrous” for hospitals, food banks and other organizations that receive charitable donations through the program. OPM recently decommissioned the CFC’s online donation portal, but the agency has not yet confirmed whether the program will be officially dismantled this year. CFC has been in operation since the Reagan administration, a program that lets federal employees contribute to charities around the world.”
  • The Wall Street Journal relates,
    • “The CDC is coordinating with the WHO on a hantavirus outbreak aboard the MV Hondius, despite the U.S. withdrawal from the WHO and CDC cuts.
    • “The U.S. formally withdrew from the WHO earlier this year, following President Trump’s executive order and criticism of its Covid-19 handling.
    • “The Trump administration reduced funding for CDC global health programs, shifting to a fee-for-service model for technical assistance.”
  • KFF Health offers more details on CMS’s Bridge program which will give eligible Medicare beneficiaries access to GLP-1 drugs for weight loss. The Bridge program runs from July 1. 2026, through December 31, 2027.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “President Trump has signed off on a plan to fire Food and Drug Administration Commissioner Marty Makary, according to people familiar with the matter, following a tumultuous period for the regulator that included clashes over vaping, abortion and drug policy.
    • ‘Makary, a former Johns Hopkins surgeon who became a frequent Make America Healthy Again surrogate on television news programs, is seen by other top administration leaders as struggling to manage his agency, sparring frequently with health department officials and at times with the White House. His tenure has also been dogged by the aftereffects of layoffs led by the Department of Government Efficiency and rapid turnover in the FDA’s leadership ranks. 
    • ‘He would become the latest top lieutenant fired under Health and Human Services Secretary Robert F. Kennedy Jr. since the ouster last summer of Centers for Disease Control and Prevention Director Susan Monarez and the February removal of HHS Deputy Secretary Jim O’Neill.
    • “Trump’s plan isn’t yet final and could change.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after identifying a software-related battery issue that could cause affected devices to enter Safety Mode and limit pacing functionality. The correction does not involve removing devices but requires clinicians to upgrade the pacemakers’ software to reduce the risk of premature battery depletion and early device replacement. According to the FDA, continued use of affected devices without the update could result in serious injury or death. Hospitals and clinicians are advised to review affected model and serial numbers, apply the software update during in office visits, monitor patients per manufacturer guidance and report adverse events through the FDA’s MedWatch program.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts. 
    • “Bizengri is the first drug approved for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
    • “This approval marks the seventh approval under the Commissioner’s National Priority Voucher (CNPV) pilot program.”
  • Fierce Pharma tells us,
    • “While Eisai and Biogen have already secured an FDA nod for a subcutaneous maintenance dose of their early Alzheimer’s disease drug Leqembi (lecanemab), the partners will have to wait a few months more for the regulator to weigh in on their proposed autoinjector initiation dose. 
    • “On Friday, the companies announced that the FDA has extended the review period for their application to advance their Leqembi Iqlik autoinjector as a starting dose for early Alzheimer’s patients. The three-month delay puts the FDA’s new target action date at Aug. 24, Biogen and Eisai said in a release.”
  • Beckers Hospital Review identifies seven prescription drugs now in shortage.
    • “Active drug shortages in the U.S. rose for the second consecutive quarter in 2026, reaching 223 in the first quarter, according to a recent report from the American Society of Health-System Pharmacists. Meanwhile, the FDA’s own database — which uses a narrower classification — lists 76 drugs currently in shortage, as of May 6.
    • “The database is updated daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
  • Here’s a link to “Brown & Brown’s May 6, 2026, PharmaLogic® Spotlight [which] reviews evolving pharmacy dynamics and trends driving prescription drug use and cost to guide benefits decision-making.”
    • “Inside this PharmaLogic® Spotlight
      • “New Drug Approvals Influencing Benefits
      • “GLP-1 Developments
      • “Drug Importation/International Sourcing
      • “Generic and Biosimilar Use
      • “Shifts in Drug Pricing Models”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today:
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is decreasing and has peaked in most regions of the country.
    • “Seasonal influenza activity is low.
    • “COVID-19 activity is low in most areas of the country.
    • “Nationally, wastewater activity levels for RSV, COVID-19 and influenza A are very low. Influenza B is not monitored in wastewater.”
  • The American Hospital Association News adds,
    • “The measles outbreak in Utah that began in June 2025 has grown to 638 cases as of May 5, according to the state’s Department of Health and Human Services. Of those, 441 have been reported this year. Nationally, there have been 1,842 confirmed measles cases in 2026, according to the Centers for Disease Control and Prevention. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape reports,
    • “Once weekly semaglutide injections reduced alcohol consumption in patients with alcohol use disorder (AUD) and comorbid obesity.
    • “Results of the randomized controlled trial (RCT), the first, to the authors’ knowledge, to evaluate the GLP-1 receptor agonist (GLP-1RA) semaglutide in patients seeking treatment for AUD who had comorbid obesity also showed significant effects on multiple alcohol-related outcomes.
    • “These data, when added to the growing evidence, demonstrate the potential of GLP-1RAs as a novel treatment for alcohol use disorder,” the investigators, led by Mette Kruse Klausen, MD, Copenhagen University Hospital in Copenhagen, Denmark, wrote.
    • “However,” they added, “corroboration with larger RCTs in nonobese patients is needed to address its generalizability.”
  • and
    • “GLP-1 receptor agonists may alter absorption of oral medications due to delayed gastric emptying, affecting drug levels and efficacy. Notable interactions include oral contraceptives, levothyroxine, and dabigatran, necessitating careful monitoring and potential dose adjustments.”
  • Health Day relates,
    • “People recovering from surgery have an easy way to boost their odds of a successful recuperation — take a stroll.
    • “Every extra 1,000 steps a patient takes daily after surgery lowers their odds of complications, researchers reported May 6 in the Journal of the American College of Surgeons.
    • “This link between extra steps and better recovery applied across different types of procedures regardless of the patients’ overall health, researchers found.
    • “Researchers discovered this after tracking nearly 2,000 people undergoing inpatient surgery who wore activity trackers while undergoing inpatient surgery.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “UnitedHealthcare has begun paying some commercial claims instantly, bypassing the standard three to five day window associated with traditional ACH transactions, the insurer said May 4.
    • “Under the new system, eligible commercial claims payments are deposited immediately into providers’ bank accounts, with remittance data routed through clearinghouses to providers’ tax identification numbers.
    • “UnitedHealthcare did not specify which claims or plan types qualify for real-time payment. The payments are not processed through Optum and will not appear on the Optum Pay platform.
    • “Providers do not need to take action to receive the payments, but UnitedHealthcare said some may need to update reconciliation workflows.” 
  • Kaufmann Hall notes,
    • “Americans are increasingly making serious trade-offs that impact their health and daily lives to afford health expenses, according to a recent report from West Health-Gallup Center on Healthcare in America. About 30% of insured and 62% of uninsured Americans—across income brackets—have made at least one or more difficult trade-off: prolonging their prescription, skipping a meal, cutting back on utilities or borrowing money. A third reported postponing vacations and surgical and medical treatment alike. These trade-offs are not “nice to have.” Not taking medication as prescribed, skipping meals, cutting back on utilities especially during extreme weather, and delaying surgical and medical treatment carry serious medical risk for harm that leads to increased ED visits, readmissions, and other avoidable costly care that may impact hospitals and health systems.
  • MedCity News relates,
    • “As patient payment responsibility grows and becomes a larger part of the overall care experience, payment decisions need more visibility across the organization, not just in finance or IT. 
    • “Healthcare organizations should begin with a practical review that includes: which payment methods are accepted at every point of care, whether FSA, HSA, and Medicare card configurations are validated across systems, where declines are occurring and why, and how long it takes patients to move from statement to payment. 
    • “Payment friction isn’t always obvious. It shows up in extended accounts receivable timelines, increased billing inquiries, and patients who delay payment – not because they’re unwilling to pay, but because the process made it harder than it needed to be. As patients become responsible for more of the bill, consistency matters. The payment process should be predictable across settings and straightforward to navigate.
    • “Payment systems may not determine whether care is delivered. But as more financial responsibility shifts to patients, they increasingly influence how that care is experienced.”
  • Modern Healthcare tells us,
    • “Sanford Health is looking to expand its Minnesota network in one of the state’s fastest-growing regions. 
    • “Sanford and North Memorial Health signed a definitive agreement to add North Memorial’s two hospitals and affiliated facilities in northwest Minneapolis to Sanford’s 58-hospital footprint, according to a Friday news release. * * *
    • “Under the agreement, Sanford pledged to update emergency services at the financially strained safety-net hospital North Memorial Health Robbinsdale. Sanford also said it plans to help double the size of North Memorial Health Maple Grove Hospital by expanding emergency care, inpatient services, surgeries and labor and delivery care. 
    • “The proposed transaction is expected to close this year, pending customary regulatory approvals.”
  • Beckers Hospital Review points out,
    • “Between the fourth quarters of 2024 and 2025, emergency department length of stay decreased 13.4% even as volumes grew 4.2% and patient acuity rose, according to a May 6 report.
    • “The report is from Sg2, a healthcare analytics and consulting company at Vizient. Through its System of CARE Scorecard, Vizient measures hospital utilization, access, safety and cost efficiency each quarter. Its latest scorecard compared the fourth quarters of 2025 and 2024 for care coordination. 
    • “On a rolling year-over-year measure, ED length of stay declined 15.2% and volume increased 4.3%, according to the report. Vizient researchers hypothesized that improvements in throughput, shifting trends in patient mix or a combination of the two could be account for these findings.” 
  • Fierce Healthcare informs us,
    • “Amazon Pharmacy will make Novo Nordisk’s Ozempic pill available for home delivery, the company announced Thursday.
    • “Per the announcement, Amazon customers will be able to secure the oral GLP-1 medication via same-day delivery or pickup within minutes at its kiosks in short order. The drug, which is approved to manage blood sugar in individuals with type 2 diabetes, was originally sold as Rybelsus but was recently rebranded to Ozempic by Novo.
    • “Amazon said that making the drug available via its pharmacy will address “a critical access gap for the more than 36 million Americans living with type 2 diabetes.”
    • “Individuals with a prescription for oral Ozempic can order the drug through Amazon Pharmacy as well as access key availability and transparent pricing data, even if they are not Prime members, the company said. Pricing is as low as $25 per month with insurance coverage.”
  • The Wall Street Journal lets us know,
    • “Sandoz Group plans to launch its generic semaglutide in Canada and Brazil this year, following patent expiration in several countries.
    • “Sandoz Chief Executive Richard Saynor stated the generic weight-loss drug market size is unknown, with initial years focused on supply.
    • “Analysts forecast Sandoz’s generic semaglutide sales to reach $742.6 million in 2035, as the overall market expands.”
  • Per MedTech Dive,
    • “Stryker has completed the acquisition of Amplitude Vascular Systems, less than a month after the deal was announced. The financial terms were not disclosed.
    • “Amplitude has developed the Pulse intravascular lithotripsy platform to treat severely calcified arterial disease. The device uses pressure waves generated by carbon dioxide and delivered through a balloon catheter to fracture the calcium and expand narrowed vessels, restoring blood flow.
    • “Stryker said adding an IVL platform will strengthen its peripheral vascular portfolio, which includes the Inari Medical clot-removal business the company acquired last year for about $4.9 billion.”

Midweek update

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The White House May 4 released its National Drug Control Strategy, which, among other efforts, recommends effective primary prevention programs. The initiative increases the implementation of evidence-based prevention strategies; establishes new partnerships with organizations supporting youth health and expanding primary prevention; supports a national media and education campaign against drug use; and supports and enhances the federal drug-free workplace program.”
  • The Centers for Medicare and Medicaid Services announced,
    • “The Centers for Medicare & Medicaid Services (CMS) will provide eligible Medicare beneficiaries access to certain GLP-1 medications for $50 per month beginning July 1, 2026, through December 31, 2027.
    • “Under the Medicare GLP-1 Bridge, a time-limited demonstration, CMS is expanding access to innovative, evidence-based weight-loss treatments. Eligible individuals enrolled in Medicare Part D prescription drug plans will be able to access these medications at a predictable and affordable cost—$50 for a monthly supply. This approach reflects CMS’ continued focus on improving access to high-value treatments that support better long-term health outcomes.
    • * * * “Beginning July 1, Medicare beneficiaries with Part D coverage may be eligible to access certain GLP-1 medications at $50 for a monthly supply. Beneficiaries can talk to their doctor to determine whether a GLP-1 medication is right for them. CMS will share additional information for beneficiaries as the program begins.
    • “In addition, CMS continues to work with stakeholders—including providers, pharmacies, and manufacturers—to support implementation and ensure all partners have the information they need ahead of launch. 
    • “The Medicare GLP-1 Bridge builds on CMS’ broader efforts to improve access to innovative therapies and support healthier outcomes for Medicare beneficiaries. For additional “demonstration details, visit: https://www.cms.gov/medicare/coverage/prescription-drug-coverage/medicare-glp-1-bridge
  • U.S. Office of Personnel Management Director Scott Kupor, writing in his Secrets of OPM blog on Substack, optimistically discusses the state of artificial intelligence.
  • Meanwhile, KFF Health News reviews “Regulation of AI in Prior Authorization and Claims Review: A Look at Federal and State Consumer Protections.”

From the Food and Drug Administation front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.  
    • “The agency also consolidated more than 40 disparate application and submission data sources, systems and portals across all FDA centers into a new platform called HALO (Harmonized AI & Lifecycle Operations for Data).The agency began integrating HALO and Elsa so that FDA staff can query data and build workflows without having to manually upload documents within each chat. The HALO consolidation is expected to enable more penetrating deployment of AI capabilities within agency operations. 
    • “Elsa’s new capabilities once again position FDA as a leader in deploying AI tools that empower staff,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Removing tedious burdens for staff enables them to focus more on science and makes their work streams more efficient and enjoyable. We have some of the best scientists in the world and we need to take good care of them.”
  • and
    • The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient. As part of this pilot, which launched in April, the agency is conducting shorter, focused screening assessments to complement standard FDA inspections. 
    • “One-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness,” said FDA Commissioner Marty Makary, M.D., M.P.H. “For the FDA, the ability to conduct shorter, targeted assessments allows for broader surveillance coverage, enabling the agency to assess more facilities and gather critical insights without compromising regulatory rigor. For industry, these assessments can provide timely feedback while minimizing operational disruption, particularly for lower-risk establishments.”
    • One-day inspectional assessments also support the development of more robust risk models across FDA programs. Data gathered through these assessments—such as recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations—can be used to better target future oversight activities.
  • MedTech Dive tells us,
    • “The Food and Drug Administration added neurosurgical supplies to its medical device shortages list on Wednesday.
    • “The regulator sent a letter to healthcare providers warning about disruptions in availability of neurosurgical patties, sponges and strip devices, which are used to absorb fluids and protect tissue during surgery.
    • “The FDA attributed the problem to recent supplier issues, noting that Medline Industries recently recalled its neuro sponge products. The agency expects the shortage to continue through the end of the year.”

From the public health and medical / Rx research front,

  • The New York Times explains,
    • “Hantaviruses have most likely been around as long as rodents, but little was known about these pathogens before the 20th century. This rare family of viruses that rodents carry has been cited as the source of a deadly outbreak aboard a cruise ship in the Atlantic Ocean.
    • “The virus is zoonotic, meaning it can be transmitted to humans from animals. And while outbreaks have been rare, it is one of the most widely distributed zoonotic viruses on Earth.
    • “Some are Old World hantaviruses and others are New World hantaviruses,” said Sabra Klein, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health.
    • “Different species of the virus are carried by different rodents,” Dr. Klein said, adding that European strains cause less severe illnesses than those from Asia.
    • She noted that “there’s no vaccine, there’s no cure, there’s no money” in finding a cure “in part because these are so rare.”
  • The Wall Street Journal adds,
    • “Hantavirus is an unlikely source of contagion on a cruise ship. The virus isn’t as infectious between humans as fast-spreading respiratory illnesses like Covid-19 and the flu. 
    • “It belongs to a family of viruses carried by rodents and spread to humans through contact with infected urine, droppings or saliva. Only one strain—the Andes virus—has shown limited evidence of human-to-human transmission. Researchers in South Africa and Switzerland confirmed this week the virus involved in the suspected outbreak is the Andes strain.
    • “Human-to-human transmission of the Andes strain requires very close contact, like sharing food or living quarters, according Steven Bradfute, an immunologist at the University of New Mexico Health Sciences Center whose lab has sequenced hantaviruses. “It doesn’t spread into huge outbreaks,” Bradfute said.
    • “WHO and other health authorities say the threat to public health is low. 
    • “Yet the ship’s passengers are at risk, as well as perhaps people they came into close and extended contact with after leaving the ship. That is why Oceanwide Expeditions, the Hondius’s operator, plus health authorities around the world and airlines, are mobilizing to trace the paths of the ship’s travelers.”
  • Fierce Healthcare reports,
    • “The Leapfrog Group highlighted broad improvements across several patient safety measures in this year’s spring release of hospital safety grades, the first reflecting changes made after a court-ordered removal of hospitals that declined to voluntarily submit information to the watchdog group. 
    • “Top marks were handed out to 917 hospitals, with Leapfrog outlining a particularly high share of “A” hospitals in the states of Connecticut (where 64% of hospitals received an “A”), Virginia (59%), South Carolina (51%), Utah (50%) and Montana (44%). 
    • “A hospital’s assigned grade is calculated by reviewing recent data on up to 22 patient safety measures, including a 10-part Medicare composite of reported patient safety and adverse events. Among these, Leapfrog said it saw “significant improvement” in 17 measures, including those related to healthcare-associated infections and medication safety plus multiple items related to patient experience. 
    • “The good news is that hospitals across the country are making meaningful strides in patient safety and helping save countless lives,” Leah Binder, president and CEO of The Leapfrog Group, said. “But not all hospitals are the same. That’s why it’s so important for people to consult Safety Grades and do their research when choosing a hospital.”
    • “Of note, the latest release excludes 450 hospitals that did not participate in Leapfrog’s 2024 or 2025 surveys.” 
  • Beckers Hospital Review points out the “eleven U.S. hospitals have earned consecutive “A” safety grades from The Leapfrog Group since 2012.” You can see “the list of Leapfrog’s five “F” hospitals here.
  • Pulmonary Advisor notes,
    • “While vaccinations showed protective trends, prior viral infections were generally linked to an increased likelihood of future respiratory illnesses.”
  • Per MedPage Today,
    • “Updated findings from a European randomized trial continued to show that colonoscopy screening significantly reduced colorectal cancer (CRC) incidence, but its impact on CRC mortality was less clear.”
  • Following up on recent Wall Street Journal articles, Cardiology Business relates
    • “Three of the leading U.S. cardiovascular health societies have joined forces for a new statement about the importance of multidisciplinary, patient-centered decision-making when managing patients with severe aortic stenosis (AS).
    • “The Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC) and Society of Thoracic Surgeons (STS) collaborated on the joint statement, calling it a response to “recent media coverage” about transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). The primary focus of the statement appears to a feature story published by The Wall Street Journal on April 23 that included interviews with patients who experienced significant complications after undergoing TAVR. 
    • “The joint statement highlights the fact that multidisciplinary heart teams are at the center of every treatment decision for patients who present with severe AS and require an aortic valve replacement. This has been the case for many years now, but coverage from The Wall Street Journal and other mainstream news outlets is sure to grab the attention of people unfamiliar with how such treatment decisions are made. 
    • “This statement serves as a fresh reminder for the general public that cardiologists and cardiac surgeons do not take these decisions lightly. The cardiology groups said years of hard work and dedication have gone into developing the framework that is now in place.”
  • Per MedTech Dive,
    • “Neptune Medical’s gastrointestinal robot met both of its primary endpoints in a clinical trial assessing the safety and feasibility of the system to perform colonoscopies.
    • “The study followed 50 adults who underwent screening, surveillance or diagnostic colonoscopy with the robotic endoscopy system at a single center in Poland for 14 days after the procedure.
    • “The results, announced Tuesday, showed no adverse events and a 100% rate of cecal intubation, where the endoscope is guided through the entire colon to the beginning of the large intestine.”
  • and
    • “Johnson & Johnson said Tuesday that a study evaluating the investigational Ottava robotic system in gastric bypass surgery met its safety and efficacy endpoints through 30 days. The average weight loss in that time frame was 30 pounds.
    • “Results from the 30-patient study were among the pre-clinical evidence included in J&J’s submission to the Food and Drug Administration, announced in January, for de novo classification of the robot in multiple procedures in the upper abdomen. 
    • “All procedures in the prospective, multicenter study were completed robotically on Ottava without conversion to a non-robotic approach, the company said. There were no adverse events related to the device.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health exceeded first-quarter earnings expectations and raised its full-year adjusted-earnings guidance.
    • “The company reported first-quarter net income of $2.96 billion, driven by a turnaround at its Aetna insurance unit.
    • “Aetna’s medical-loss ratio was 84.6%, below analysts’ projections, but 2027 Medicare rates still fall short.”
  • Modern Healthcare relates,
    • “Humana plans to cut Medicare Advantage supplemental benefits in 2027 in a strategic shift for the insurer.
    • “Medicare Advantage payments are not keeping pace with medical costs, President and CEO Jim Rechtin said.
    • “Medicare Advantage membership was 22.6% higher in the first quarter.
    • “Humana downgraded its annual earnings guidance.”
  • Beckers Payers Issues tells us,
    • “Oscar Health reported a net income of $679 million in the first quarter of 2026, according to a May 6 earnings release. This marked the highest quarterly profit in the company’s history, nearly 2.5 times greater than profit in the first quarter of 2025.
    • “Membership reached roughly 3.2 million members, a 56% year-over-year increase. The company’s medical loss ratio was 70.5%, compared to 75.4% during the same period last year.
    • “Total revenue reached $4.6 billion, up 53% year over year. Earnings from operations were $704.1 million, more than double from the first quarter of 2025.
    • “The company also reaffirmed its 2026 guidance. The strong quarter follows a $443 million net loss in 2025.”
  • Fierce Healthcare informs us,
    • “Hinge Health boosted its full-year revenue outlook by $64 million as the company reported a stronger-than-expected first quarter and kicked off an expansion of its business beyond muscle and joint pain.
    • “The digital musculoskeletal (MSK) care provider, which went public nearly a year ago, brought in first-quarter revenue of $182 million, up 47% year-over-year from $123.8 million in Q1 2025. The company posted first-quarter adjusted earnings of 45 cents per share, significantly exceeding Wall Street analyst estimates of 12 cents per share. Hinge Health’s non-GAAP income from operations jumped 208% to $46.2 million compared to non-GAAP income from operations of $15 million during the same quarter a year ago.
    • “The company’s results easily topped Wall Street analyst estimates, with a revenue target of $172 million for the quarter and a Street estimate of $31.2 million for operating income.”
  • and
    • “Amwell, the telehealth platform formerly known as American Well, brought in $54.9 million in first-quarter revenue, down approximately 18% the same period a year ago, as executives discussed artificial intelligence and key contract renewals with investors on Tuesday.
    • “The company is shifting towards subscription revenue, and in Q1, subscription software revenue was 53% of total revenue at $24.9 million, which Chief Financial Officer Mark Hirschhorn said was down “approximately 23%” year-over-year in a May 5 call to discuss Q1 results. 
    • “Encouragingly, renewals and retention were higher than budgeted in the first quarter, providing greater confidence in the stability of our subscription base going forward,” Hirschhorn said.
    • “Amwell’s visit volume was down approximately 19% compared to a year ago, according to Hirschhorn, with 1.1 million visits in Q1. Hirschhorn said the figure is “is in line with the portfolio changes” previously disclosed by the company.”
  • The Wall Street Journal lets us know,
    • “BioNTech plans to shrink its workforce and manufacturing network to cut costs after Covid-19 vaccine demand waned.
    • “The company will affect 1,860 roles, about 22% of its 8,400-person workforce, and exit manufacturing plants.
    • “BioNTech will hand Covid shot supply to Pfizer, pivot to cancer therapies, and projects 500 million euros in annual savings by 2029.”
  • and
    • “Bayer agreed to acquire Perfuse Therapeutics, an eye disease drug specialist, for up to $2.45 billion.
    • “The acquisition aims to complement Bayer’s ophthalmology pipeline, following patent expiration issues with its Eylea drug.
    • ‘Perfuse’s lead drug candidate is an experimental treatment for glaucoma and diabetic retinopathy in mid-stage trials. Bayer will pay $300 million upfront.”
  • Per Fierce Pharma,
    • “Since the start of the decade, Eli Lilly has committed to spend more than $50 billion to bolster its United States manufacturing capabilities. But even that’s not enough to meet the needs of the rapidly growing pharma giant.
    • “On Wednesday, Lilly said that it has earmarked another $4.5 billion to further build up two of three planned production facilities in Lebanon, Indiana, some 28 miles northwest of Lilly’s headquarters in Indianapolis. The company revealed the new investment at a ribbon cutting ceremony for its genetic medicine plant in Lebanon, the first of the three new facilities at the site to become operational.
    • “Of the sum Lilly has pledged to spend for its domestic manufacturing in this decade, more than $21 billion has been allocated for the buildup in its home state. Lilly’s “evolving pipeline” and shifts in the anticipated demand for its products dictated the additional funding, the company said.”





Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, Patient safety, Telehealth, U.S. Healthcare–

Scheduling note: Because one of the FEHBlog’s children is getting married on May 1, there will be no Friday report this week.

From Washington, DC,

  • Federal News Network reports,
    • “President Donald Trump swiftly signed a bipartisan legislation Thursday to fund much of the Department of Homeland Security, but not its immigration enforcement operations, shortly after the package won final approval in the House, ending the longest agency shutdown in history.” * * *
    • “The White House had urged Congress this week to act, warning that the money Trump tapped to temporarily pay TSA and other workers through executive actions was drying up.” * *
    • “With the budget resolution now adopted by the House and Senate, lawmakers will next draft the actual $70 billion ICE and Border Patrol funding bill, with voting expected in May. 
    • “Trump has said he wants it on his desk by June 1.”
  • The Wall Street Journal reports,
    • “President Trump is withdrawing his nomination of healthy-food advocate Dr. Casey Means to serve as U.S. Surgeon General, after it became clear that the champion of his administration’s Make America Healthy Again agendawas unable to secure support in the Senate for confirmation.
    • “The president said Thursday that he instead would nominate Dr. Nicole B. Saphier, the director of breast imaging at Memorial Sloan Kettering Cancer Center Monmouth and a former Fox News contributor, for the role. * * *
    • “Trump’s new nominee, Saphier, has supported Kennedy’s efforts to probe the cause of rising autism rates in the U.S., but has expressed some criticism of his approach. “Mr. Kennedy’s commitment to addressing the autism epidemic is a welcome change. But as a physician, mother and medical journalist, I am deeply concerned—not with Mr. Kennedy’s intent, but with his methods,” Saphier wrote last year in a Wall Street Journal opinion column.”
    • “She is also a supporter of the MMR vaccine and has publicly cited studies showing no link between the vaccine and autism. Saphier has praised Trump for delivering Covid-19 vaccines through Operation Warp Speed, but criticized mandates under the Biden administration that she says undermined confidence in the vaccine.”
  • STAT News adds,
    • “The Food and Drug Administration has named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research, which regulates vaccines, gene therapies, and the blood supply. 
    • “A Health and Human Services official confirmed the move, which was first reported by Politico, to STAT. 
    • “She is replacing Vinay Prasad, who left the agency on Thursday after a tumultuous tenure during which he issued a series of controversial decisions on rare disease drugs and vaccines. FDA Commissioner Marty Makary said in March that Prasad would return to the University of California San Francisco. 
    • “Szarama joined the FDA at the end of last year to serve as Prasad’s deputy. She trained as a biophysicist at Johns Hopkins and the Karolinska Institutet. Later, she worked as a research analyst at the Centers for Medicare and Medicaid Services, a director of clinical trials at Arnold Ventures, and a program manager at the Advanced Research Projects Agency for Health, according to her LinkedIn profile.” 
  • Per a CMS news release,
    • “Following overwhelming interest from prescription drug manufacturers, the Centers for Medicare & Medicaid Services (CMS) is extending the application deadline for drug manufacturers to apply to the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model. The deadline extension to June 11, 2026, from April 30, 2026, provides interested drug manufacturers, particularly those that are small to mid-sized, with more time to engage with the CMS Innovation Center, review participation information and prepare their application to join the model.
    • “Additionally, CMS is extending the deadline for drug manufacturers to enter into participation agreements from June 30, 2026, to July 17, 2026. Companies that manufacture at least one drug and that participate in the Medicaid Drug Rebate Program are eligible to apply to participate in the GENEROUS Model, which is intended to offer improved and streamlined access for state Medicaid programs to participating manufacturers’ products. 
    • “Interested drug manufacturers that wish to schedule a meeting with CMS about their potential participation in the model should contact generousmodel@cms.hhs.gov.” 
  • Tammy Flanagan, writing in Govexec, helpfully “sorts through Medicare myths in federal retirement decisions.”
    • “Common assumptions about Part B, IRMAA and FEHB coordination can obscure how coverage and costs actually play out over time.” Check it out.

From the Food and Drug Adminstration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity in 2022 to treat major depressive disorder in adults.
    • “This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer’s disease,” said FDA Commissioner Marty Makary, M.D., M.P.H. “With today’s action, patients and their families have access to an additional important treatment for complications of this devastating disease.”
    • “Agitation is a common and distressing symptom in patients with Alzheimer’s disease dementia, characterized by excessive motor activity, or verbal or physical aggression. It can significantly impact quality of life for patients and caregivers.”  * * *
    • “The FDA granted breakthrough therapy designation and priority review designation for this action. The approval of Auvelity for agitation associated with dementia due to Alzheimer’s disease was granted to Axsome Therapeutics.”
  • and
    • “The U.S. Food and Drug Administration today announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. 
    • “The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In most cases, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing. 
    • “After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances. 
    • “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”
  • Healio tells us,
    • “The FDA approved Breztri Aerosphere, a single-inhaler triple therapy, as a maintenance treatment for patients aged at least 12 years with asthma, according to a press release from AstraZeneca.” * * *
    • “Notably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.”
  • MedTech Dive informs us,
    • “The Food and Drug Administration has recommended that users of Trividia Health’s True Metrix devices switch to other methods of testing their blood glucose. 
    • “Officials made the recommendation on Tuesday because the devices show the same error code when a patient has very high blood glucose or when there is a problem with the test strip.
    • “Trividia has recalled millions of owners’ booklets and systems instruction documents in response to the problem. The meter, test strips and control solution remain on the market.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports
    • “The CDC sent an alert to state and local health departments April 27, warning that additional measles cases are expected over the next few months.
    • “With continued measles transmission in areas across North America and expected increases in international and domestic travel and large events during spring and summer, additional measles cases are anticipated in the coming months,” the alert said.” 
  • Radiology Business points out,
    • “Nearly half of women eligible for breast cancer screening are confused on when exactly they should begin said screenings, according to new survey data. 
    • “The survey was the result of a collaboration between the Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. It was distributed in early April and included a sample of more than 1,000 women. Responses revealed that 44% of participants still believe they should begin breast cancer screening starting at age 50. While this assumption is in line with prior recommendations, the U.S. Preventive Services Task Force updated its guidelines in 2024 to recommend women at average risk undergo biennial screening starting at age 40.”
  • The Washington Post points out,
    • “Some physicians and researchers have argued for years that emotional dysregulation is not peripheral to ADHD but a central, overlooked part of the condition. Yet this symptom does not appear in the formal diagnostic criteria for ADHD in the manual that doctors use to classify mental disorders. That gap has left clinicians without a clear way to categorize what they’re seeing: Are these children best understood as having severe anxiety, as being on the autism spectrum, or as something else entirely? Or does ADHD itself need to be more broadly defined?
    • “A study published in JAMA Psychiatry this year analyzing 1,154 brain scans of children and adolescents offers fresh evidence for reevaluating the medical establishment’s definition of the disorder.
    • “The researchers grouped three forms of ADHD identified in the imaging into familiar — and one less familiar — categories: predominantly inattentive; predominantly hyperactive/impulsive; and a more severe, combined presentation marked by emotional dysregulation or difficulty managing and responding to emotions in a controlled, appropriate way.
    • “The findings are part of a broader shift: Advances in brain imaging are pushing scientists beyond symptom-based labels toward biologically grounded classifications of neurological conditions — an approach already reshaping autism research, where a study published last year identified four distinct subtypes.”
  • STAT News relates,
    • “Body mass index has its limitations, but for now it’s the metric medicine often defaults to when predicting weight-related health problems. A new tool promises to better define who’s at risk for obesity complications, based on measures that include BMI but also family history, diet, current illness, and socioeconomic factors culled from medical records.” * * *
    • “We really wanted to have an integrated model that enables us to look at not one, but 18 different obesity-relevant complications,” Claudia Langenberg, co-author of a study about the new model published Thursday in Nature Medicine, said in a media briefing Tuesday. She is director and professor of medicine and population health at Precision Healthcare University Research Institute of Queen Mary University of London.
    • “The new tool, called OBSCORE, stratifies 10-year risk for different outcomes at 5.7%, 1.8%, 0.9%, 0.4%, and 0.1% for death from, for example, cardiovascular causes. 
    • “What needs to happen next is to take this very helpful score and to incorporate it, as the team have done, with evidence from trials to show that people are not only at risk, but estimate what their capacity to benefit is — and then the cost-effectiveness of intervention,” co-author Nick Wareham, co-director of the Institute of Metabolic Science at the University of Cambridge, said at the briefing.”
    • “Experts not involved in the study praised its ambition to predict obesity’s serious ramifications, but they differed on how well this step toward early recognition and refined response might play out.”
  • The Washington Post informs us,
    • “A drug taken by thousands of Americans to improve longevity might have an unexpected side effect, a study has found. It may blunt some of the health benefits of exercise.
    • “The drug, rapamycin, is approved by the Food and Drug Administration to prevent organ-transplant rejection in people. But recent studies in yeast, flies and mice showed that relatively low doses of the drug often increase the creatures’ lifespans, prompting many longevity enthusiasts to start using it off-label to extend their lifespans.
    • “The new study, published this month in the Journal of Cachexia, Sarcopenia and Muscle, is among the first to look at interactions between rapamycin and exercise. The researchers anticipated rapamycin would enhance the effects of exercise, while also initiating health improvements of its own.”
    • “But the results surprised them, said Brad Stanfield, a physician and researcher in Auckland, New Zealand, who led the study. The sedentary, older people taking a low dose of rapamycin once a week during the study wound up gaining less strength and physical function from an exercise program than other volunteers of the same age who were taking a placebo. They also developed more aches, fatigue and, in one case, a serious infection.
    • “These findings resonate because, exercise is the most effective way to improve health and longevity as we age. “It is important to understand how potential health span-extending drugs” such as rapamycin “interact with other health span-extending treatments like exercise,” said Benjamin Miller, who studies aging and metabolism at the Oklahoma Medical Research Foundation in Oklahoma City. He was not involved with the new study.
    • “Since exercise is the benchmark,” he continued, “we do not want to inhibit its potential benefits.”
  • Health Day tells us,
    • “Screening for dementia doesn’t appear to stress out seniors’ families
    • “Family members whose seniors received screening were no more anxious than those who didn’t 
    • “However, screening alone did not lead to family members better prepared for caregiving.”

From the healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “Cigna Group will exit the Affordable Care Act market next year, the latest sign of turmoil in a business that has been hit hard by the loss of federal subsidies.
    • “Cigna will be the second major health insurer to leave the rapidly shrinking ACA market, after CVS Health’s Aetna stopped offering plans at the start of this year.” 
  • Modern Healthcare adds,
    • [Cigna] reported first-quarter profit ahead of Wall Street estimates and lifted its outlook for the year as healthcare expenses in its medical plans came in lower than forecasts.
    • Adjusted earnings of $7.79 a share topped the average analyst estimate in a Bloomberg survey. Cigna nudged its 2026 profit outlook up by 10 cents a share to at least $30.35, the company said in a statement Thursday. A key gauge of medical costs was more favorable than Wall Street expected. 
    • The results extend a string of favorable reports from US health insurers for the start of 2026. Cigna’s medical plan business drove the company’s earnings, while the company’s Evernorth health services segment, which includes the largest US drug benefits manager, powered revenue growth. Selling, general and administrative expenses declined from a year ago.
  • Fierce Healthcare relates,
    • “Tenet Healthcare topped its earnings expectations for the year’s first quarter, with CEO Saum Sutaria, M.D., crediting the company’s long-term strategy and “old-fashioned discipline” in the face of volume disruptions plaguing providers in the opening months of 2026.
    • “The company’s net income for the quarter was $8.01 per diluted share ($702 million), or a market consensus-beating 10.6% year-over-year increase to $4.82 per share after adjustments (including over $400 million received from the early severance of a revenue cycle contract with CommonSpirit Health). Net operating revenues increased 2.8% year over year to $5.37 billion, falling short of the market’s consensus estimate.
    • “Executives said they were pleased with the performance of both major segments of Tenet’s business, its ambulatory surgery business and its hospitals.” 
  • and
    • “Parsley Health, a functional medicine provider, is now in-network with all major commercial insurers nationwide.
    • “The company’s in-network reach spans plans covering 150 million lives, including Aetna, Cigna, UnitedHealthcare, Blue Cross Blue Shield, Humana and Centene. Eligible services covered include provider visits, diagnostic testing and prescriptions. Parsley members must pay an annual non-covered program fee of $1,500 for wraparound support.
    • “The announcement builds on Parsley’s phased expansion into insurance over the past two years, which began in New York and then California. Today’s nationwide expansion represents a tenfold increase in coverage, per the company. The company offers healthcare via telehealth nationwide or in-person in Los Angeles and New York City.” * * *
    • “Functional medicine aims to look at the whole person and get under the hood of symptoms to identify and address root causes of disease. Parsley takes a multidisciplinary approach, with members getting a care team of board-certified doctors, registered nurses, functional nutritionists, care coordinators, member experience advisors and access to the digital platform to track progress, access data and more. Members also get unlimited messaging with their care team.” 
  • The Wall Street Journal tells us,
    • “Booming sales of weight-loss shots fueled strong revenue and profit growth for Eli Lilly LLY  in the latest quarter, as robust consumer demand helped offset falling prices for the drugs.
    • “The results blew past Wall Street expectations, and Lilly raised its forecast for full-year 2026 sales and profit.” * * *
    • “The results cement the Indianapolis company’s dominance in the anti-obesity drug market as it seeks to extend that to weight-loss pills. Lilly released its new weight-loss pill Foundayo this month, competing with Novo Nordisk’s Wegovy pill, which came out in January.
    • “Early prescription data showed a slower start for Lilly’s pill than for Novo Nordisk’s, but analysts predict Lilly’s pill will eventually be a big seller.
    • “Both companies think there is a large, untapped market for pill versions of weight-loss drugs, because some people don’t like needles or find pills more convenient.”
  • and
    • “Merck reported higher first-quarter sales and raised its full-year earnings guidance as demand for its flagship Keytruda cancer drug continues to grow.
    • “Sales rose 5% to $16.29 billion, boosted by 12% growth for Keytruda. Wall Street had expected $15.85 billion, according to FactSet.
    • “The company has been adding to its portfolio as it braces for Keytruda to lose the protection of its main U.S. patent, which expires in 2028, opening the door for lower-cost versions to compete.
    • “Last year, the FDA approved a form of Keytruda administered by injection rather than intravenously, which could help the company offset the impact of the patent expiration. Merck has said the new form of the drug, called Qlex, provides greater convenience as it can be offered in a wider variety of settings and can be given in one minute every three weeks as opposed to a 30-minute IV infusion.
    • ‘In the first quarter, the company recorded $128 million in Qlex sales.”
  • and
    • “Bristol Myers Squibb BMY posted higher first-quarter revenue boosted by its portfolio of newer treatments for heart and blood conditions.
    • “The biopharmaceutical company on Thursday posted a profit of $2.68 billion, or $1.31 a share, compared with $2.46 billion, or $1.20 a share, a year earlier.
    • “Stripping out certain one-time items, adjusted per-share earnings were $1.58, ahead of the $1.42 anticipated by analysts, according to FactSet.
    • “Revenue rose 3% to $11.49 billion. Analysts surveyed by FactSet forecast revenue of $10.93 billion.
    • “Sales in Bristol Myers Squibb’s growth portfolio rose 12%, driven by Camzyos, Breyanzi and Reblozyl. The drugs are designed to treat heart disease, lymphoma and blood disorders, respectively.”
  • Health Exec notes “six things the hospital-at-home model needs to scale up nationally.”
  • Beckers Payer Issues calls attention to “five ways insurers are betting big on AI.”
    • “Payers have been experimenting with internal and member-facing capabilities, while grappling with health system AI use, as well. As insurers build upon their substantial investments and weigh how humans can stay “in the loop,” here is where that money is actually going.”

Monday report

David Ermer–CDC, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Beckers Hospital Review reports,
    • “Americans spend more than $1.6 trillion a year on hospital care — roughly one-third of all health spending — and a new paper from the nonprofit think tank Paragon Health Institute argues that government policy is the primary driver of why those costs keep climbing.
    • “The paper, “The Hospital Cost Crisis: How Government Policies Drive Consolidation, Undermine Competition, and Fuel Soaring Prices,” was authored by John Graham, a visiting fellow at Paragon with nearly three decades of health policy experience.” * * *
    • Click here to read the paper in full. FEHBlog note — The article includes ten highlights from the report.
  • and
    • “Johnson & Johnson will begin marketing four prescription drugs on the Trump administration’s TrumpRx website, according to an April 24 report from CBS News.
    • “The drugs include metformin, metformin extended release, Invokana and Xarelto. Pricing on the platform shows Invokana discounted 62% to about $225 from $598.56, Xarelto discounted 68% to about $197 from $611.82, and Invokamet XR — an extended-release combination of canagliflozin and metformin — discounted 62% to about $225 from $598.56, based on listed cash-pay prices.”
  • MedPage Today relates,
    • “Advocates for the LGBTQ+ community claimed a win this week after the Trump administration pledged to reinstate the 988 Suicide and Crisis Lifeline specialized support program tailored to their needs.
    • During a Senate hearing earlier [last] week, HHS Secretary Robert F. Kennedy Jr. was asked whether he would commit to restoring the tailored line for LGBTQ+ callers to 988, as required by law, after the Trump administration removed it last summer.
    • “We are working on getting it up now,” Kennedy said.
    • “While most 988 calls are routed to the nearest call center, callers who press 3 or text PRIDE were once connected to a centralized network of trained crisis counselors who have shared lived experiences or are trained to provide services to LGBTQ+ youth.
    • “Linking callers to local resources is usually best, since support outside of a phone call might be needed. However, for those in states where attacks on LGBTQ+ individuals are widespread, local resources may not be preferred, Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness, told MedPage Today.“
  • The American Hospital Association News tells us,
    • “The AHA again is asking the Health Resources and Services Administration to take action after Eli Lilly warned hospitals that they could lose access to discounted drug prices unless they comply with new data submission requirements.
    • “The AHA said Eli Lilly recently issued a letter to hospitals participating in the 340B Drug Pricing Program threatening the “imminent loss” of discounted pricing if claims data are not submitted “without further delay.”
    • “The AHA for months has raised concerns with HRSA about these practices.
    • “Unfortunately, we are not aware of any action that HRSA has taken to address these unlawful drug company claims-data policies, even as more and more companies have announced policies similar to Lilly’s,” the AHA wrote. “HRSA’s inaction here stands in stark contrast to the speed with which it acted in 2024 when the drug companies announced their unlawful rebate policies.”

From the Food and Drug Administration front,

  • Health Exec reports,
    • “Multiple wound and burn gel products are being removed from where they are used or sold, after it was discovered that a packaging failure was leading to the sterile barrier being breached. Unfortunately, this has led to at least 14 serious injuries. 
    • “The manufacturer of the gels, Integra LifeSciences, issued a letter to distributors of the products,  branded as MediHoney and CVS Wound Gel. The products are sold in retail settings, but also may be found in patient care settings. 
    • “In a statement, the U.S. Food and Drug Administration (FDA) said it’s aware of the issue and provided the known details. The agency said it has determined that using wound gels with the defective packaging may “cause temporary or reversible health problems, or—though unlikely—serious health problems.”
    • “Despite the risk of severe infection and the recorded injuries, there are no known deaths associated with the recalled wound gels.” 
  • The American Hospital Association adds,
    • “The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable Sheath Introducers be taken out of use due to a design defect where the sheath introducer may not split as intended. In addition, the FDA issued an Early Alert for Omnicell i.v.STATION sterile labels. Omnicell recommends customers do not use affected labels. They should verify the accuracy of labels on filled products.”
  • Fierce Pharma tells us,
    • “AstraZeneca’s systemic lupus erythematosus (SLE) med Saphnelo may have earned a considerable convenience edge in the United States, courtesy of an FDA nod clearing the drug for self-administration via a once-weekly autoinjector. 
    • “As with the drug’s original SLE nod in 2021, the self-administration green light covers the use of Saphnelo on top of standard therapy, AZ said in an April 27 release. In its original formulation, Saphnelo, also known as anifrolumab, is given as an intravenous infusion. 
    • “The FDA signed off on the new administration route after reviewing data from the late-stage TULIP-SC study, in which subcutaneous dosing of Saphnelo triggered statistically significant and clinically meaningful disease activity reductions versus placebo, according to AZ.”
  • and
    • “Johnson & Johnson is bolstering the case for its approved schizophrenia med Caplyta to prevent relapses in the disease. 
    • “On Monday, the FDA approved J&J’s supplemental new drug application for the atypical antipsychotic to include long-term data on the med’s schizophrenia relapse-prevention capabilities.
    • “In a press release, J&J clarified that the “label update builds upon the existing clinical data and postmarketing experience across [Caplyta’s] approved uses.” 
    • “Relapses pose a significant challenge for schizophrenia patients and can disrupt stability, undermine functioning and often trigger episodes of psychosis, hallucinations and other symptoms that have the potential to disrupt daily life, according to J&J. On average, adults living with the condition experience nine relapse episodes within a six-year period, the company added.” 

From the public health and medical / Rx research front,

  • NBC News reports
    • “Deaths from rectal cancer are rising rapidly among younger adults, an alarming trend that is confounding scientists trying to understand why millennials are so hard-hit. 
    • “The rate of rectal cancer seems to be increasing more than two to three times compared to colon cancer,” said Mythili Menon Pathiyil, lead author of a new study and a gastroenterology fellow at SUNY Upstate Medical University in Syracuse, New York. 
    • “If the trend continues, rectal cancer deaths will exceed the number of colon cancer deaths — already the nation’s No. 1 cause of cancer death in people under age 50 — by 2035.”
    • “According to the American Cancer Society, 158,850 new colorectal cancers will be diagnosed in 2026. About 55,230 patients will die from the disease, with nearly a third of those deaths in people under age 65. Colon cancer and rectal cancer are similar but form in different parts of the digestive tract. 
    • “The new research, which hasn’t yet been published in a peer-reviewed journal, is scheduled to be presented at Digestive Disease Week, an annual meeting of gastroenterologists, in May. 
    • “The findings, however, strengthen an American Cancer Society study released in March showing that a rise in rectal cancer rates is driving increases in colorectal cancer diagnoses in people younger than age 65. Colorectal cancer rates have been increasing 3% each year for adults under age 50 since the late 1990s and scientists are scrambling to understand why.”
  • STAT News considers what happened to COVID?
    • “There is an ever-shrinking portion of the population that thinks it’s never been infected — the folks who call themselves Novids. Even among that population, many have all but certainly been exposed to the virus but had only asymptomatic infections.”
    • “This, many experts told STAT, explains why the threat from Covid has subsided.” * * *
    • “Most of the experts STAT consulted believe the virus either now qualifies as, or is on its way to becoming, just another one of the viruses that make people sick with cold or flu-like symptoms — with some caveats. For one, the risk remains high for some people — particularly older people, very young children, and people with medical conditions that weaken their immune systems. For another, cold and flu-like viruses trigger symptoms that range from sniffles and coughs to knock-you-off-your-feet illness. A bad case of flu can take a couple of weeks to recover from, even for a healthy person. Same with Covid.” * * *
    • “Marion Koopmans, scientific director of the Pandemic and Disaster Preparedness Center at Erasmus University in Rotterdam, the Netherlands, said at this point, annual boosting is probably not doing much for people who aren’t at high risk.
    • “What we really would need is data on what the effect is of boosting on variant specific responses AND protection from disease over increasing intervals between boosters. That data is virtually impossible to get,” she wrote in an email. (Pfizer recently announced it had halted a clinical trial the Food and Drug Administration asked it to conduct in healthy adults aged 50 to 64, because it couldn’t recruit enough volunteers.) 
    • “But for high-risk individuals, Covid boosters still offered protection against becoming sick enough to require hospitalization, the latest study in the Netherlands concluded, Koopmans said.”  
  • MedPage Today adds,
    • “Two multicenter trials [(PANORAMIC and CanTreatCOVID)] found no change in hospitalization and death rates when antiviral nirmatrelvir-ritonavir (Paxlovid) was given to COVID-19 patients already mostly vaccinated.” * * *
    • “Now, the PANORAMIC and CanTreatCOVID results reflect a COVID-19 landscape that’s shifted since the pandemic’s early period, said H. Clifford Lane, MD, former deputy director for clinical research and special projects at the National Institute of Allergy and Infectious Diseases (NIAID), and Anthony Fauci, MD, the former NIAID director.
    • “These new data indicate that the 89% relative risk reduction seen in the analysis of hospitalizations or death associated with the use of nirmatrelvir-ritonavir in the EPIC-HR trial does not apply to the current circumstances, in which most adults have varying degrees of preexisting immunity and the circulating variants are different,” Lane and Fauci wrote in an accompanying editorialopens in a new tab or window.
    • “That doesn’t mean nirmatrelvir-ritonavir’s therapeutic time has come and gone, they cautioned. PANORAMIC and CanTreatCOVID participants who took the combination drug saw enhanced recovery and faster viral load reductions, they noted, which points to both clinical efficacy and antiviral activity.”
  • Health Day tells us,
    • “The eyes are the windows not only to the soul, but also to a person’s health, a new study says.
    • Premature aging of the retina could be a red flag for major diseases like diabetes or heart disease, researchers recently reported in the journal Communications Medicine.
    • “They found that people had a higher risk of chronic disease if they had advanced aging of their retinas — the light-sensitive layer of cells that lines the back wall of the eye.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded clinical study shows that a symptom-based treatment for babies with neonatal opioid withdrawal syndrome (NOWS) — a highly prevalent condition wherein opioid exposure during pregnancy leads to withdrawal after birth — could speed up their recovery.
    • “To treat babies with moderate to severe symptoms of NOWS, doctors often administer opioid medication, lowering the dose over time. Many doctors commonly use this scheduled dosing approach, however, the new study found that providing “as-needed” doses of opioid medications based on each baby’s signs of withdrawal helped them stop the medicine sooner and go home earlier.
    • “Scheduled opioid dosing, which includes a taper, is necessary for some infants with NOWS, however it may overtreat others,” said corresponding author Lori Devlin, D.O., a professor of pediatrics at the University of Louisville and Norton Children’s Neonatology. “The idea is that by matching treatment to disease severity, we can accelerate recovery and minimize exposure.”
  • Genetic Engineering and Biotechnology News informs us,
    • “A cellular-resolution molecular map details how Down syndrome alters human brain development before birth. The study analyzed more than 100,000 nuclei from human prenatal neocortex samples collected across 26 pre-genotyped donors during gestational weeks 13 to 23—the only window during which all the cortical neurons a person will carry for their entire life are generated. The findings suggest that Down syndrome disrupts the developmental sequence of that process, creating shifts that may help explain later differences in cognition, learning, and sensory processing.
    • “This work is published in Science in the paper, “A single-cell multiomic analysis identifies molecular and gene-regulatory mechanisms dysregulated in developing Down syndrome neocortex.“
    • “There’s a new level of detail here that had never existed before,” said Luis de la Torre-Ubieta, PhD, an assistant professor of psychiatry and biobehavioral sciences at UCLA and a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research. “For the first time, we can really try to understand systematically what’s going on in the developing brain of individuals with Down syndrome.”
  • STAT News points out,
    • “The drugmaker Erasca said Monday that its RAS-targeting pill shrank tumors in 40% of patients with advanced pancreatic cancer and 62% of patients with advanced non-small cell lung cancer, results that the company said exceeded its expectations. 
    • “The new data, collected from studies done in the U.S. and China, are still preliminary. However, Erasca said the clinical benefit and tolerability of its drug, called ERAS-0015, compared favorably to daraxonrasib, a similar RAS-targeting drug from Revolution Medicines that recently showed a doubling of overall survival in patients with advanced pancreatic cancer.
    • “I’m excited about both datasets, but I think lung is more definitive at this point. The pancreatic results are maturing, but are very, very promising,” Erasca CEO Jonathan Lim told STAT. “All options are on the table.” 
  • and
    • “An oral medicine for hair loss successfully spurred hair growth in a late-stage trial, startup Veradermics announced Monday.
    • “Veradermics assessed the pill in two ways: by how many hairs grew within a square centimeter of the scalp, on average, and by how satisfied participants were with the results. Over the course of six months, men who took the drug, known as VDPHL01, either once or twice daily had between 30 and 33 more hairs per square centimeter of scalp. Men in the placebo group grew approximately seven additional hairs.
    • “Between 79% and 86% of men taking VDPHL01 said they saw improvement, along with between 72% and 84% of the clinical trial investigators — results that pleased Reid Waldman, a dermatologist turned Veradermics’ chief executive.” 
  • BioPharma Dive adds,
    • “An experimental gene editing medicine from Intellia Therapeutics has succeeded in a Phase 3 trial, positioning the company to seek approval of what would be the first treatment of its kind for a rare disorder known as hereditary angioedema.
    • “When compared to a placebo, the therapy, “lonvo-z,” reduced the rate of the disease’s hallmark swelling attacks by 87% over the course of about six months, meeting the study’s primary objective. Lonvo-z also helped rid 62% of recipients of disease attacks or the need for other therapies during that follow-up period, versus 11% of placebo patients.
    • “Intellia said, without specifics, that lonvo-z had a “favorable” safety and tolerability profile. The most common treatment-emergent side effects were infusion-related reactions, headache and fatigue, and all reported by a Feb. 10 data cutoff were mild to moderate in degree. The company has begun a “rolling” U.S. approval submission and, assuming a clearance, intends to launch lonvo-z in the first half of 2027.” 

From the U.S. healthcare and artificial inteliigence front,

  • Beckers Payer Issues reports,
    • “Elevance Health has set aside $935 million to cover potential costs tied to its ongoing risk adjustment data dispute with CMS, which threatens the insurers’ ability to enroll new members into some of its Medicare Advantage plans.
    • “CFO Mark Kaye disclosed the charge during the company’s first quarter earnings call on April 22, saying the figure reflects Elevance’s current best estimate of what the issue could cost as it works toward a resolution with the government.
    • “[Elevance CEO Gail} Boudreaux also characterized the issue as a historical payment dispute rather than a current compliance concern.”
  • and
    • “CenterWell, Humana’s pharmacy branch, is collaborating with Mark Cuban’s Cost Plus Drug Co. for an employer-based program, according to an April 27 news release.
    • “CenterWell will use Cost Plus Drugs’ SwiftyRx, a digital pharmacy software-as-a-service solution, for medication order intake. The platform should enable CenterWell to offer home delivery pharmacy services for the insurer’s eligible workforce in the Humana Associate Benefit Plan.
    • “Along with SwiftyRx, the organizations will harness Cost Plus Drugs’ drug pricing and CenterWell’s distribution strategies. The collaboration aims to ease access and reduce patient cost through smoother onboarding, automated benefit checks, lowered costs to fill prescriptions and operational efficiency.” 
  • Healthcare Dive points out,
    • Nearly three-quarters of U.S. finance leaders rank healthcare among their companies’ five biggest operating expense concerns, consulting firm Mercer found in a recent survey.
    • “The research comes as the rapid rise of GLP-1 weight-loss medications — like Wegovy and Ozempic — is adding to volatility in employer health costs.
    • “The survey results make clear the far-reaching impacts of rising health benefit costs for individual organizations,” Susan Potter, president of Mercer U.S. & Canada, said in an emailed statement. “Only about one in four CFOs said that their organization was able to absorb the cost increases over the past two years without any business impacts, such as slower wage growth, reduced hiring, or higher prices.”
  • Fierce Healthcare relates,
    • “Insurers are putting a growing focus on specialty drugs covered under the medical benefit, and on re-evaluating the efficacy of traditional rebate models, according to a new report.
    • “The Pharmaceutical Strategies Group (PSG) on Monday released its annual Trends in Specialty Drug Benefits report, which offers a look at how payers are responding to rising costs for these products and striking a balance between cost management and access.
    • “PSG surveyed 228 benefits leaders representing employers, health plans and union coverage, and found that 43% ranked managing specialty drug costs as their top goal. By comparison, 37% said their No. 1 goal is to manage total cost of care, per the report.
    • “As more and more of these products come to market and existing drugs gain new indications, managing them across the pharmacy and medical benefits poses significant complexity, the report found. More payers listed this as a top challenge than access to integrated data or member affordability.”
  • The Wall Street Journal reports,
    • “Eli Lilly agreed to acquire Ajax Therapeutics for up to $2.3 billion to bolster its blood-cancer portfolio.
    • “Ajax Therapeutics is developing AJ1-11095, a Type II JAK2 inhibitor for myelofibrosis patients.
    • “Eli Lilly’s deal to buy Ajax adds to a recent spate of pharma acquisitions, including several by Lilly.”
  • and
    • [India’s] Sun Pharmaceutical Industries will acquire U.S.-listed Organon for $11.75 billion, becoming a top three global women’s health player.
    • Organon, a Merck spinoff, has over 70 products in women’s health and general medicines, commercialized across 140 countries.
    • Sun Pharma will fund the all-cash deal through internal cash and bank financing; the acquisition will make it a top seven global biosimilars player.
  • and
    • “Ligand Pharmaceuticals LGND said it has reached a deal to acquire Xoma XOMA Royalty, a company that invests in a range of biotech firms, for around $740 million.
    • “Under the terms, Ligand will pay $39 a share in cash for Xoma, a 2.9% premium over the $37.90 closing price on Friday. The deal is expected to close in the third quarter.
    • “Both Ligand and Xoma are known as royalty aggregators for investing in drugs while they are in development and then, if they work out, collecting royalties from their sales.
    • “By absorbing Xoma, Ligand’s total portfolio would more than double in size to more than 200 drugs and experimental treatments, including a handful of medicines on the market and several in late-stage studies.”
  • MedTech Dive adds,
    • “Johnson & Johnson said Friday it has struck a deal to buy Atraverse Medical, an atrial fibrillation ablation device developer founded by the team behind Farapulse.
    • “Atraverse sells a radiofrequency guidewire used to create an atrial septal defect to treat AFib. The Food and Drug Administration cleared the Hotwire device for use in 2024.
    • “Hotwire competes with products including Boston Scientific’s ProTrack RF Anchor Wire, which Atraverse cited as the predicate product in its 510(k) submission.”
  • Beckers Health IT observes,
    • “For years, the conversation about AI in health systems centered on technology adoption: which tools to buy, which pilots to run, which workflows to automate. But as health systems move from isolated AI deployments toward enterprise-wide agentic platforms, the limiting factor is no longer the technology. It’s the people managing it.
    • “That was the central tension running through a panel of health system technology leaders at Becker’s 16th Annual Meeting in Chicago this spring. Across organizations ranging from a large rural integrated delivery network to an urban academic medical center to a national cancer system, the same challenge surfaced: operations leaders have not yet grasped that they are now managing a digital workforce — and the consequences of that gap are starting to show.
    • “The biggest barrier to us moving forward is really getting operations to understand that this fundamentally changes their role in the equation,” said Jeff Gautney, CIO of Rush University Medical Center in Chicago. “They are managing a digital workforce and they need to think that way as opposed to [thinking that] IT is monitoring this, IT is keeping an eye on it, IT is delivering this solution and I don’t really need to think any differently about it.”
  • MedCity News adds,
    • “There are plenty of AI startups on the market promising to bolster hospitals’ finances by increasing revenue. But that’s not the case for San Francisco-based Midstream Health.
    • “For most health systems, the key to unlocking dollars isn’t boosting revenue — it’s decreasing costs, said Venkat Mocherla, Midstream’s co-founder and president.
    • “Midstream, founded in 2023, uses AI to clean up and unify hospitals’ fragmented financial and operational data, which helps leaders spot savings opportunities and make smarter purchasing decisions, he explained. For instance, the platform could help surface insights that help a hospital capture missed rebates or avoid overpaying for supplies and devices.” * * *
    • T”he company’s platform is being used across health systems including Mount Sinai, CommonSpirit and Houston Methodist. Midstream primarily makes money by taking a cut of the savings it generates, which Mocherla noted aligns the startup’s incentives directly with hospitals’ financial outcomes.”

Noteworthy Death

  • Cardiovascular Business reports,
    • “Pioneer cardiologist Eugene Braunwald, MD, often referred to as the “father of modern cardiology,” died April 22. He was 96 years old.
    • “Braunwald was born in Vienna, Austria, and immigrated to the United States as a child to flee Nazi persecution. He went on to hold leadership positions with the National Heart, Lung and Blood Institute; the University of California, San Diego; Brigham and Women’s Hospital and Harvard Medical School. He authored or co-authored more than 1,000 publications over the course of his career and helped shape medical education for many years as the longtime editor of Harrison’s Principles of Internal Medicine, a premier textbook for clinicians. 
    • “Braunwald was also a lifelong contributor to a variety of industry societies, including the American College of Cardiology (ACC), American Heart Association (AHA) and European Society of Cardiology (ESC). He earned the highest honors from all of these groups over the course of his career in medicine, and the AHA even started giving out the Eugene Braunwald Academic Mentorship Award annually in 1999.”
  • RIP

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, Patient safety, U.S. Healthcare–

From Washington, DC

  • The Thompson Hine law firm tells us,
    • “The Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) recently released their 2025 Report to Congress on enforcement activity under the Mental Health Parity and Addiction Equity Act (“MHPAEA”).” * * *
    • “Both the DOL and the Centers for Medicare & Medicaid Services (CMS) issued more requests for comparative analyses signaling that enforcement was active in the two year period.” * * *
      • “Employers should continue to pay careful attention to the following specific types of NQTLs that continue to draw the most scrutiny from the Departments:
      • “Provider network admission standards,
      • “Prior authorization requirements,
      • “Concurrent care review requirements, and
      • “Exclusions of key mental health and substance use disorder treatments (such as ABA therapy, methadone maintenance treatment, and nutritional counseling for eating disorders).”
  • Healthcare Dive reports,
    • “A pilot program that adds artificial intelligence-backed prior authorization for some services in Medicare is delaying care for seniors in Washington, according to a report released Wednesday by one of the state’s Democrat senators. 
    • “Under the WISeR program, procedures that were previously approved within about two weeks now take four to eight weeks to be authorized, according to survey data from the Washington State Hospital Association.
    • ‘The pilot is creating increased administrative work for providers in the state, as well as potentially worsening health outcomes for patients whose care is delayed, the report released by Sen. Maria Cantwell, D-Wash., found. “It’s not taking a few days to find out whether you’re going to get covered or not,” Cantwell said during a Senate Finance Committee hearing Wednesday. “It’s basically taking weeks to find out you were denied.”
  • KFF News relates,
    • “More than 12 million people — about 43% of those in traditional Medicare [including the FEHBlog] — buy a Medigap policy. Others rely on some sort of retiree employer coverage or a different backup. About 13% of people in traditional Medicare don’t have supplemental coverage, according to KFF, meaning they could be vulnerable to large costs if they have a serious illness.
    • “In the supplemental market, following big increases last year, rates appear to be rising again. In early 2026 filings with state insurance commissioners from Aetna, Blue Cross Blue Shield, Cigna, Humana, Mutual of Omaha, and UnitedHealthcare, rate increases for Plan G policies — the most commonly purchased supplement type — ranged from just over 12% to more than 26% in the first quarter, according to Nebraska-based consulting firm Telos Actuarial.
    • “While this is a small dataset across a select number of states, it’s an indication that carriers are looking to correct their premium rates in light of upward pressure on their claims experience,” said Brett Mushett, a consulting actuary with Telos.”
  • Contemporary OB/GYN lets us know,
    • “The American Medical Association (AMA) and the Current Procedural Terminology (CPT) Editorial Panel have approved a comprehensive restructuring of maternity care services codes, marking a departure from the long-standing global payment model, according to an announcement from the Association. 
    • “Beginning January 1, 2027, the CPT code set will transition to a granular framework that replaces the traditional bundled payment model with codes that accurately represent 4 distinct phases of care: 
      • “Antepartum 
      • “Labor management 
      • “Delivery 
      • “Postpartum.
    • “This transition follows nearly 2 years of collaborative efforts between the AMA, the American College of Obstetricians and Gynecologists (ACOG), and various national medical specialty societies. By moving away from the legacy global model, which historically reported maternity care as a single service, the new structure is designed to reflect the realities of modern, team-based obstetric practice, a change that ACOG is welcoming.” * * *
    • “To facilitate this transition, the AMA is releasing the 2027 codes ahead of the standard schedule to ensure that physicians, payers, and EHR vendors have sufficient time to prepare. ACOG and the AMA have developed several educational resources to support clinicians through this transition as they move toward a framework that supports improved transparency and risk adjustment.¹
    • “You can view and download these codes via the AMA website, here.”
  • The American Hospital Association News informs us,
    • “The AHA April 24 urged the Sequoia Project to delay implementation of the Trusted Exchange Framework and Common Agreement Individual Access Services Exchange Purpose Standard Operating Procedures version 3.0 until key legal and regulatory issues are resolved. The proposed IAS SOP, slated for implementation by August 2027, includes new patient-matching methodologies that bypass or limit provider verification, which the AHA argues could expose hospitals to unauthorized disclosures, data breaches and misidentification errors. 
    • “The AHA emphasized that hospitals and health systems are already legally bound to verify identity, consent and authority before disclosing protected health information, warning that the proposed IAS SOP does not adequately account for these statutory obligations, creating significant compliance and liability risks for covered entities. To address the risks, the AHA recommended delaying the SOP and pursuing statutory or regulatory solutions, such as a provider safe harbor or clear regulatory guidance confirming compliance with IAS satisfies the Health Insurance Portability and Accountability Act verification and consent requirements.” 

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration today announced it is accelerating regulatory action on a new class of psychedelic-based therapies, following an April 18 executive order calling to speed up access to treatments for serious mental illness. The agency said it will prioritize development and review of serotonin-2A agonists for conditions such as treatment-resistant depression, post-traumatic stress disorder and substance use disorders, including issuing national priority vouchers for studies of the drugs psilocybin and methylone for alcohol use disorder. The FDA also noted it would aim to balance urgency with rigorous science and to expect final guidance for study sponsors soon.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19
      • COVID-19 activity is low in most areas of the country.
    • “Influenza
      • Seasonal influenza activity continues to decrease. Influenza A activity is low across all regions and influenza B activity continues to trend downward.
      • Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue through April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • National vaccination coverage for COVID‑19, influenza, and RSV remained low among both adults and children. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • The American Hospital Association News reports,
    • “The Utah measles outbreak has increased to 607 cases, the state’s Department of Health and Human Services reported April 24. Nationwide, there have been 1,792 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 93% of cases are outbreak-associated, and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • The Hill relates,
    • “With spring in full force and summer on the way, the Centers for Disease Control and Prevention (CDC) is raising the alarm on tick bites.
    • “The agency says the bites are sending Americans to the emergency room(ER) at the highest rate in nearly 10 years. 
    • “During the second week of April, 71 out of every 100,000 emergency room visits were for tick bites, according to the CDC.
    • “The administration’s data notes that the Northeast region of the country has seen the largest spike in ER visits, followed by the Midwest.
    • “To avoid potential tick bites, the CDC recommends steering clear of wooded and brushy areas with high grass and leaf litter. They also advise checking animals that go outside every day during warm weather.”
  • The University of Minnesota’s CIDRAP tells us,
    • “Transmission of clade 1 mpox virus during commercial air travel appears to be uncommon, according to a study published yesterday [April 23] in Morbidity and Mortality Weekly Report from the US Centers for Disease Control and Prevention (CDC).” 
  • The American Medical Association lets us know what doctors wish patients knew about cervical cancer prevention.
  • MedPage Today points out,
    • “The epidemiology of sudden cardiac deaths (SCDs) was turned on its head Thursday, with research showing that in reality, ischemic cardiac disease is not the leading driver of SCDs, as previously thought.
    • “From a prospective autopsy study of unselected deaths in San Francisco County, California, it was evident that out of 943 presumed SCDs, 62% were autopsy-confirmed, and only 41% of those were due to myocardial infarction (MI) upon comprehensive postmortem and histologic evaluation — “one-half the long-accepted 80% prevalence among SCDs,” according to Zian Tseng, MD, MAS, of University of California San Francisco, and colleagues of the POST SCD study.
    • “For the remaining 59% of autopsy-confirmed SCDs not traced to an MI, they can be explained by a range of causes including hypertensive heart disease, dilated cardiomyopathy, substance-related cardiomyopathy, and normal heart primary electrical disease. When an MI was involved, nine in ten cases were attributed to acute or healed MI with obstructive coronary artery disease, and one in ten related to acute MI with nonobstructive coronary arteries (MINOCA).
    • “The study was presented at the annual meeting of the Heart Rhythm Society (HRS), held in Chicago this year. A full manuscript was published in the Journal of the American College of Cardiology.”
  • Per a National Institutes of Health news release,
    • “A large clinical trial supported by the National Institutes of Health (NIH) compared two commonly used treatments for pediatric patients treated for septic shock and found no difference in meaningful outcomes. The trial, which enrolled over 9,000 participants across five countries, sought to answer a longstanding question about which intravenous crystalloid fluid type was the superior option for children who were in septic shock, a life-threatening condition triggered by severe infection which requires immediate medical treatment.
    • “For decades, pediatricians have debated which is the best intravenous resuscitation treatment for children with severe infections who have suspected septic shock,” said Rohan Hazra, M.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the study. “This largest-ever clinical trial for children treated for septic shock has immediate clinical application and allows physicians caring for these vulnerable patients to know they can confidently choose either intervention as a standard of care.”
  • Per Medscape,
    • “New drugs approved in 2025 are poised to significantly improve the management of motion sickness, acute pain, urinary tract infections (UTIs), and chronic spontaneous urticaria.
    • “Gerald W. Smetana, MD, a professor emeritus of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, talked about new treatments in a presentation at the American College of Physicians Internal Medicine (ACP-IM) Meeting 2026 in San Francisco.
    • “This is the first time in my 15-year history of giving this new drugs talk that I’ve given all four drugs a thumbs-up, with the potential to change practice,” Smetana said during his presentation.”
  • Per Health Day,
    • “For adults with type 2 diabetes (T2D), a ketogenic diet (KD) reduces the proportion of proinsulin secreted to a greater extent than a low-fat diet (LFD), according to a study published online April 21 in the Journal of the Endocrine Society.” * * *
    • “We showed that three months of a ketogenic diet was able to improve beta-cell function in patients with T2D, and these improvements were associated with changes in the PICP ratio, a biomarker of pancreas stress,” Yurchishin said in a statement. “Other than bariatric surgery or large-volume intentional weight loss, interventions for improving beta-cell function in T2D do not currently exist.”
  • The Wall Street Journal notes,
    • “A health-tech startup, NewDays, developed an AI chatbot named Sunny to help people with dementia practice communication skills.
    • “NewDays’ service combines telehealth visits with bot practice; a study found seven of nine patients showed cognitive improvement.
    • “A clinical trial, on which NewDays’ therapy is based, found participants had higher cognitive scores than the control group.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “U.S. health insurers are accelerating efforts to streamline prior authorization requirements, with UnitedHealthcare, Aetna and Cigna on Friday detailing progress toward industry commitments aimed at reducing administrative burdens and speeding patient access to care.
    • “UnitedHealthcare said more than half of its prior authorization volume will be incorporated into a standardized electronic submission process, with that share expected to exceed 70% by the end of 2026.
    • “Aetna, a unit of CVS Health CVS -1.59%decrease; red down pointing triangle, said it has already standardized 88% of its prior authorization volume. The company also said it is processing 83% of requests in real time, ahead of a 2027 goal set by insurers, and that more than 95% of eligible requests are approved within 24 hours.
    • “Cigna said it expects to standardize electronic prior authorization submission requirements for more than 70% of volume by the end of the year.
    • “All the companies emphasized the use of automation and digital tools to reduce administrative friction for providers. Aetna said it has eliminated more than 1 million provider calls through automation, while UnitedHealthcare highlighted efforts to reduce documentation requirements and limit the need for follow-up information.”
  • Fierce Healthcare relates,
    • “HCA Healthcare executives worked to reassure investors that lower-than-expected patient volumes during the first quarter are in the past and not expected to diminish the company’s full-year growth targets. 
    • “In quarterly numbers released Friday morning and discussed during an earnings call, the executives focused on two curveballs—a sharp end to the flu season and disruptive winter storms—which said were almost entirely offset by unexpected receipt of Medicaid state supplemental payments. 
    • “Specifically, the quarter’s respiratory-related admissions declined 42% year-over-year while respiratory-related emergency room visits were down 32%, translating to a 70 basis point drag for the former and a 140 basis point dip for the latter. In Texas, Tennessee, North Carolina and Virginia, the inclement weather reduced admissions and ER visits by 30 basis points and 50 basis points, respectively. 
    • “The two factors hit volumes across payer categories and resulted in an estimated $180 million hit to HCA’s adjusted EBITDA, they said. 
    • “On the other hand, an expected $80 million net benefit increase to adjusted EBITDA compared to Q1 2025 related to the supplemental payments was, in reality, about $200 million, thanks to program approvals and reinstatements in Georgia and Texas.” 
  • Kaufmann Hall adds,
    • “Kaufman Hall’s latest National Hospital Flash Report underscores persistent cost pressures that continue to strain hospital and health system finances. Calendar year-to-date margins adjusted for corporate allocations declined at the start of the year. Operational shifts—fewer inpatient days, greater reliance on outpatient revenue, and softer, uneven volumes—reflect an ongoing transition in where and how care is delivered.”
  • MedTech Dive tells us,
    • “Edwards Lifesciences increased its full-year financial forecast as sales of its transcatheter aortic replacement valves grew at a faster-than-expected pace in the first quarter.
    • “Edwards CEO Bernard Zovighian said on a Thursday earnings call that the upturn in first-quarter TAVR sales reflects a move away from watchful waiting in clinical practice for patients with severe heart valve disease.
    • “There has been a shift toward proactive disease management with an increased focus on evaluation and intentional referral of patients with severe aortic stenosis earlier in the disease pathway,” Zovighian told analysts and investors.
    • “He said heart patients are being referred for valve replacement sooner due to the company’s study data that points to better outcomes with earlier treatment and the long-term durability of its Sapien valves. It was Edwards’ third consecutive quarter of double-digit TAVR sales growth.”
  • The Wall Street Journal cautions,
    • “After months of dizziness and arms aching so badly, she could barely walk her dog, Susan Glannan lay stunned in a sunny hospital room as a doctor told her she should have open heart surgery. 
    • “The idea of a surgeon cracking her chest open and stopping her heart terrified her. Glannan, who was 64, lived alone. She didn’t have her affairs in order. And just four years earlier, she had had a procedure that she thought would take care of her heart problem—a diseased aortic valve. “I was disappointed and scared,” she said, “and I started worrying, ‘Do I have a will?’” 
    • “That first procedure was called a transcatheter aortic valve replacement, or TAVR. It’s considered one of the biggest innovations in cardiovascular medicine, offering a way to spare patients the physical and emotional trauma of open heart surgery.
    • “TAVR was approved in 2011 for frail, older patients unlikely to withstand surgery—people with no more than a few years left to live. The Food and Drug Administration later approved it for healthier patients at intermediate and low risk of dying from surgery.
    • “Yet there’s limited research on how long the valves might last. And as TAVR has become more widely used among younger and healthier people, some are finding that their valves don’t work as well or last as long as they hoped. The procedure they thought would spare them a complicated surgery leads some to the operating table anyway.”

Thursday report

David Ermer–ACA, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News reports,
    • “The Senate April 23 adopted a budget resolution by a 50-48 vote, paving the way for a narrow reconciliation bill focused on immigration enforcement funding. Congressional Republicans are seeking to use the reconciliation process primarily to end the partial shutdown of the Department of Homeland Security. The resolution instructs the Senate Homeland Security and Governmental Affairs Committee, the Senate Judiciary Committee, and the House Homeland Security and Judiciary committees to write legislation by May 15 that provides up to $70 billion in funding.  
    • “The vote followed a lengthy “vote-a-rama” session overnight that consisted of multiple proposed amendments from Democrats that failed to pass. Both chambers must pass a common budget resolution to move forward with the reconciliation process. Legislative action is expected in the House as early as next week.”  
  • STAT News reports,
    • “President Donald Trump’s acting attorney general on Thursday signed an order reclassifying state-licensed medical marijuana as a less-dangerous drug, a major policy shift long sought by advocates who said cannabis should never have been treated like heroin by the federal government.
    • “The order signed by Todd Blanche does not legalize marijuana for medical or recreational use under federal law. But it does change the way it’s regulated, shifting licensed medical marijuana from Schedule I — reserved for drugs without medical use and with high potential for abuse — to the less strictly regulated Schedule III. It also gives licensed medical marijuana operators a major tax break and eases some barriers to researching cannabis.
    • “The Trump administration also said it was jump-starting the process for reclassifying marijuana more broadly, setting a hearing to begin in late June.”
  • The Wall Street Journal tells us “What to Know About the Health Risks of Marijuana.”
    • “Studies show the drug can exacerbate anxiety and teen use poses risks for developing brains.”
  • STAT News adds,
    • “President Trump heralded a drug pricing agreement with Regeneron on Thursday, closing the last of 17 deals initially sought by the White House last year.
    • “Regeneron, as part of the private deal, will reduce prices on drugs to Medicaid, provide cholesterol medicine Praluent on TrumpRx for $225, and invest $27 billion in drug development in the United States.”
  • Tammy Flanagan, writing in Govexec, lets us know,
    • “I was planning to write about the number of TSP millionaires for this week’s column — until I started getting messages from former federal employees, all who retired on September 30, 2025, and are still waiting for their retirement benefit from the Office of Personnel Management (OPM) to be finalized.
    • “It is not completely surprising that retirement processing has slowed down, and for some former employees, they continue to wait for their retirement benefits to be finalized. But for the employees who have reached out for assistance, many have not received any money since their last paycheck was received in October 2025.
    • “It has been almost six months with very little or, in some cases, no money and little communication to help them understand how long they will have to continue to wait.” * * *
    • “In my experience, retirement processing is less like flipping a switch and more like closing out a file with dozens of tabs. One missing document or unresolved question can stop forward progress.
    • “Common culprits include late or incomplete payroll certifications, missing service history, unposted deposits or redeposits for prior service, unresolved military service credit, periods of leave without pay that need to be documented, name discrepancies, incomplete beneficiary or survivor elections, or court orders that require special handling.
    • “None of these problems are rare, and when thousands of cases arrive at once, the odds go up that more people land in the exception pile.”
    • Tammy then make suggestion on steps to take.

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices.
    • “The pathway, called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, allows the two health agencies to work together, and with companies, during the device review process to speed up Medicare coverage for certain FDA-designated Class II and Class III breakthrough medical devices.
    • “The approach could enable Medicare national coverage and payment as soon as two months after a device has received market authorization, compared with approximately one year or more under the current system, according to the Thursday announcement.”
  • The Wall Street Journal relates,
    • “Children born deaf because of a rare condition can now take a drug to restore their hearing after a gene therapy was approved in the U.S., ushering in a new era for the treatment of an inherited form of hearing loss. 
    • “The Food and Drug Administration approved Regeneron Pharmaceuticals’drug Otarmeni for children born with a faulty gene that plays a role in hearing. It targets a rare condition affecting an estimated 20 to 50 newborns in the U.S. each year and could eventually be expanded to an even wider population if additional studies succeed.
    • “In my wildest dreams I never thought we’d be here in my lifetime,” said Lawrence Lustig, a hearing specialist at Columbia University Irving Medical Center who helped lead the trial.
    • “Regeneron said it would offer the drug free to people in the U.S.”
  • MedTech Dive tells us,
    • “Tandem Diabetes Care issued an urgent medical device correction for a software problem with its Mobi insulin pumps.
    • “The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. 
    • “Tandem sent a letter to customers in October notifying them of the fault and instructing them to update their pump software as soon as possible. Tandem had reported four serious injuries related to the problem as of Nov. 4.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Federal Trade Commission has reached an agreement in principle with U.S. Anesthesia Partners to settle the government’s 2023 lawsuit. 
    • “The terms of the preliminary settlement are confidential so USAP can carry out the negotiations necessary to fulfill them, the FTC said in a Thursday news release.
    • “The agency in its original complaint claimed the anesthesiology group allegedly violated antitrust laws and reduced competition for anesthesia services in Texas. The preliminary settlement resolves the charges, the FTC said Thursday.” 
  • The New York Times points out “A $440,000 Breast Reduction: How Doctors Cashed In on a Consumer Protection Law.”
    • A law meant to end surprise medical billing accidentally created a multibillion-dollar industry that is making doctors richer.”
  • FEHBlog observation – This is happening. Why can’t Congress and the regulators fix the problem?

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk will seek regulatory approval for its semaglutide pill to treat Type 2 diabetes in children and adolescents after a late-stage trial showed it significantly reduced blood sugar in 10- to 17-year-olds.
    • “The once-daily semaglutide pill is currently marketed as Rybelsus in the EU and U.S. to treat diabetes in adults and will be available in the U.S. as Ozempic pill later in the second quarter. It is not currently approved for use in children or adolescents.
    • “The Danish drugmaker said Thursday that oral semaglutide has the potential to be the first oral GLP-1 to demonstrate a superior reduction in blood sugar levels compared with a placebo in children and adolescents with Type 2 diabetes, while maintaining the well-tolerated safety profile seen across other semaglutide trials.
    • “Over the past two decades, the prevalence of Type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need,” said Martin Holst Lange, Novo Nordisk’s chief scientific officer and head of research & development.”
  • MedPage Today relates,
    • “An investigational benzamide antipsychotic significantly improved symptoms in hospitalized adults with acute schizophrenia in a phase II trial.
    • “The drug, N-methyl amisulpride, is similar to its predecessor, amisulpride, but has some key differences in dosing and side effects.
    • “Because of the 4-week trial duration, long-term treatment durability wasn’t evaluated.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Diabetes affects over half a billion people globally. Along with direct consequences to those with the disease, it also contributes to and predisposes affected individuals to a host of other conditions. Specifically, it is a known contributing factor in the development of vascular disease, including peripheral artery disease. While therapies exist, they are not very effective, and peripheral artery disease can lead to restricted blood flow in peripheral limbs, which sometimes leads to amputation. Understanding the mechanism driving the connection at the tissue and cellular level has the potential to improve therapy options and the development of new treatments.
    • “Normal function of the peripheral vasculature requires communication and cooperation between the vascular endothelium and macrophages. “Monocytes patrol the vascular endothelium and remove damaged cells, and intimal-resident macrophages maintain a nonthrombogenic endothelial state,” wrote the authors of a study led by Zhen Chen, PhD, at City of Hope. They explained that under stress, macrophages can modulate vascular remodeling and in certain conditions, like cancer, they “can secrete inflammatory mediators to disrupt endothelial cell tight junctions and increase endothelial cell permeability.”
    • “The team decided to explore the cellular cross-talk between macrophages and endothelial cells, as well as the resulting vascular function, to better understand the mechanisms behind peripheral artery disease induced by diabetes.
    • “They published their work in a paper titled “Diabetes-induced TREM2–endothelial cell signaling impairs ischemic vascular repair” in Science Translational Medicine.“
  • Healio tells us,
    • “Influenza vaccination continues to protect children from influenza-related outpatient visits and hospitalizations, according to post-pandemic data published in Pediatrics.
    • “We have had really severe recent seasons for flu, particularly in children,” Samantha M. Olson, MPH, an epidemiologist in the CDC’s influenza division, told Healio in an interview. “This study really adds to the growing body of evidence showing how protective flu vaccines can be for infants, children and adolescents, and this includes even the most severe outcomes.”
  • and
    • “People taking GLP-1s had reduced risk for atrial fibrillation, regardless of whether they lost weight or how much they lost, according to findings presented at Heart Rhythm 2026.
    • “We were prompted to undertake this study by some encouraging data that … GLP-1 receptor agonists seem to have a favorable effect on reducing the incidence of atrial fibrillation, particularly in patients with metabolic risk factors,” Kenneth C. Bilchick, MD, MS, professor of cardiovascular medicine at the University of Virginia School of Medicine, who presented the findings, told Healio. “I think the results were expected, but they were even better than we thought they would be.”
  • Health Day informs us,
    • For many women, a sudden sneeze or a hearty laugh bring an unwelcome consequence: A small leak of urine. 
      Often dismissed as a normal part of aging or motherhood, new research suggests the real culprit may lie deep within the abdomen.
      A study from the Federal University of São Carlos (UFSCar) in Brazil found that hidden fat stored between internal organs is a major driver of stress-induced urinary incontinence.
      The research — published recently in the European Journal of Obstetrics & Gynecology and Reproductive Biology — suggests that where a woman carries her weight matters far more than the number on the scale.
      Stress urinary incontinence occurs when everyday actions like coughing, lifting or exercising put too much pressure on the bladder, causing urine to leak.
      “It’s that urinary leakage that occurs when pressure inside the abdomen increases and the pelvic floor can’t hold it in,” Patricia Driusso said in a news release. She’s a professor of physical therapy at UFSCar.

From the U.S. healthcare business and artificial intelligence front,

  • Healthcare Dive reports,
    • “Molina benefited from better controlled Medicaid spending in the first quarter, though steeper membership losses than expected raise questions about whether the insurer can keep costs in hand for the remainder of 2026.
    • “Molina posted better-than-expected first quarter earnings on Wednesday afternoon, sending the insurer’s stock up more than 10% in Thursday morning’s trade.
    • “Yet, unlike its peers UnitedHealth and Elevance, which both raised 2026 guidance after keeping medical spending in check, Molina elected to reaffirm its outlook.
    • “Executives said retaining the current 2026 guidance is prudent given it’s early in the year and the cost environment remains challenging. Still, they hinted Molina might update the outlook after the second quarter.”
  • Fierce Healthcare relates,
    • “Elevance Health’s top brass told investors Wednesday that the insurer is on pace to end the second quarter of 2026 with about 1.2 million members in its individual market plans.
    • “CEO Gail Boudreaux said on the company’s earnings call that the company saw “moderately stronger retention” in the Affordable Care Act segment through Q1, and that it was one of the contributing factors to its better-than-expected results in the quarter.
    • “The membership growth in the individual market plans reflected a shift toward bronze tier coverage following the expiration of enhanced premium tax credits at the beginning of this year, said Chief Financial Officer Mark Kaye. Part of why this trend contributed to lower medical costs is that utilization in these plans is frequently backloaded, he said.” * * *
    • “Kaye said that the company feels good about its position in the ACA market, and the shift to bronze tier plans has been positive in certain markets. However, the company is still taking a prudent approach to forecasting around the ACA market.”
  • Beckers Hospital Review identifies “eight health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2026.”
  • MedTech Dive tells us,
    • “Boston Scientific slashed its 2026 sales growth and earnings guidance on Wednesday as key businesses are facing challenges and setbacks.
    • “The medtech company expects full-year sales growth in a range of 7% to 8.5%, down from a range of 10.5% to 11.5% given in February. Boston Scientific also lowered its adjusted earnings per share guidance from a range of $3.43 to $3.49 to a range of $3.34 to $3.41.
    • “CEO Mike Mahoney told investors on an earnings call that the lowered guidance reflects challenges in several prominent businesses, including electrophysiology and the company’s Watchman franchise.
    • “This was a guide down that we, quite frankly, are not proud of, but we think it’s the right thing to do, and best reflects the current environment,” Mahoney said.”
  • Beckers Health IT informs us,
    • “OpenAI has introduced ChatGPT for Clinicians, offering free use of the tool to all verified U.S. physicians, nurse practitioners, physician assistants and pharmacists.
    • Here are [four] things to know from an April 22 news release and past Becker’s reporting:
      • “1. The AI developer said the solution can help clinicians with tasks like documentation, writing and medical research, freeing up time for patient care.
      • “2. OpenAI has previously launched ChatGPT for Healthcare, an enterprise solution for health systems, and ChatGPT for Health, a tool for users to ask health-related questions.
      • “3. The company also debuted HealthBench Professional⁠, a benchmarking application for three use cases: care consultation, documentation and writing, and medical research.
      • “4. OpenAI said its physician advisors review the AI’s healthcare responses “every few minutes” and before releasing ChatGPT for Clinicians tested nearly 7,000 conversations in their daily work, rating 99.6% of responses as accurate and safe.”
  • Healthcare Dive adds,
    • “The American Medical Association is urging Congress to create safety guardrails for artificial chatbots in mental healthcare, as Americans increasingly turn to the technology for health information and advice. 
    • “In letters sent Wednesday to the chairs of three congressional committees on digital health and AI, the major physician lobby said “well-designed, purpose-built” tools could help patients who would otherwise struggle to access mental healthcare, but that the lack of safety protocols poses serious risks.
    • “Privacy concerns, risks of emotional dependency on AI and reports the tools could encourage self-harm signal that “immediate attention is required to ensure these tools do not inadvertently harm individuals seeking mental health support or companionship,” AMA CEO Dr. John Whyte wrote.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network offers an interview with Tammy Flanagan about how “health‑coverage decisions in retirement can shape when and how federal retirees tap their money.”
  • Govexec reports,
    • “The percentage of federal employees who are classified as “thriving” decreased by 10 points between 2024 and 2025, according to a recent report from Gallup, which sheds light on how civil servants are reacting to cuts and other reforms that President Donald Trump has made to agencies since the start of his second term. 
    • “By taking the average of responses from quarterly surveys conducted respectively in both years, the analytics firm found that the percentage of “thriving” feds dropped from 58% in 2024 to 48% in 2025.” * * *
    • “While the “thriving” rate for federal employees held steady at around 60% from 2022 to 2024, the latest data puts them on par with the average for U.S. workers in general, which also stood at 48% in 2025. That broader group, however, saw a smaller decline, going from 51% in 2024.”
  • OPM has brought the Director’s Secrets of OPM blog posts up to date on the agency’s website, which may be more easily accessible than Substack.
  • Per a CMS email,
  • This reporting requirement applies to FEHB and PSHB plans.
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services April 9 held a demonstration showcasing the first series of products intended to push the health care industry toward a more connected ecosystem. The event highlighted tools and applications from more than 50 companies supporting the Medicare App Library that was initially announced in February. Tools intended to promote digital data access and eliminate manual check-in forms were featured, along with personalized health apps providing tailored guidance for nutrition, wellness and chronic disease management.” 
  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services has proposed a 2.4% payment rate bump for inpatient services for fiscal year 2027 as well as the first mandatory, nationwide test of an episode-based payment model. 
    • “The plans were outlined Friday in the annual release of CMS’ Inpatient Prospective Payment Systems (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System proposed rule. 
    • “Other planned changes, according to a fact sheet from the agency and the proposed rule’s summary, include various measure additions or modifications to measures in the Hospital Inpatient Quality Reporting Program; adjustments to the Transforming Episode Accountability Model (TEAM) alternative payment model controversially finalized in last year’s rule; and changes to graduate medical education payments to implement discrimination requirements aligned with the administration’s view of diversity, equity and inclusion practices.” 
  • A CMS news release adds,
    • “Medicare beneficiaries undergoing knee, hip, and ankle replacements, among the most frequent surgeries for people with Medicare, could soon experience more coordinated care and lower costs under a new Centers for Medicare & Medicaid Services (CMS) proposal. CMS is looking to implement these improvements by expanding the Comprehensive Care for Joint Replacement (CJR) Model nationwide through the Fiscal Year (FY) 2027 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule.
    • “Every year, Medicare funds thousands of knee, hip, and ankle replacements that help seniors keep up with their speedy little grandkids,” said CMS Administrator Dr. Mehmet Oz. “This proposed expansion of our successful joint replacement pilot program would better align financial incentives with improved health outcomes—protecting taxpayer dollars while ensuring patients get the care they need before, during, and after surgery.” * * *
    • “To learn more about the CJR-X Model, including independent evaluation reports, visit: https://www.cms.gov/priorities/innovation/innovation-models/cjr-x“
    • “The FY 2027 IPPS and LTCH PPS proposed rule can viewed on the Federal Register at: https://www.federalregister.gov/public-inspection/current. 
    • “For a fact sheet on FY 2027 IPPS and LTCH PPS proposed rule, visit: https://www.cms.gov/newsroom/fact-sheets/fy-2027-hospital-inpatient-prospective-payment-system-ipps-long-term-care-hospital-prospective.”
  • Fierce Healthcare relates,
    • “The Trump administration has issued a proposed rule that aims to significantly overhaul prior authorization for pharmaceuticals.
    • “Through the Interoperability Standards and Prior Authorization for Drugs rule, the Centers for Medicare & Medicaid Services said it would establish deadlines for payers in government insurance plans, setting the timeline at 24 hours for urgent requests and 72 hours for standard determinations.
    • “In addition, the rule would require insurers to publicly report certain metrics around prior authorization, including approval and denial rates; outcomes for appeals; and decision timeframes, according to an announcement from the agency.”
    • “The rule also builds on a 2024 regulation that took aim at prior authorization for non-drug services as well as payers’ 2025 pledge to significantly overhaul their approach to prior auth, an agreement brokered in part by CMS officials.” * * *
    • “CMS would also push to adopt Fast Healthcare Interoperability Resources (FHIR)-based standards for the small number of plans still using older models, making it easier for real-time electronic workflows to thrive.”
  • and
    • “Despite encountering a legal roadblock last month in his effort to rework the U.S. vaccine infrastructure, HHS secretary Robert F. Kennedy Jr. is continuing to reshape the Centers for Disease Control and Prevention’s vaccine advisory panel in a way that’s setting off alarm bells for some experts.
    • “In the new charter for the Advisory Committee on Immunization Practices (ACIP), the focus of the group—which helps advise the CDC on vaccine schedules and recommendations—seems to be shifting more toward concerns around vaccine safety and side effects. 
    • “In particular, the panel will now work on identifying “gaps in vaccine safety research, including adverse effects following vaccination.” The language is new in the updated charter and will likely appease the vaccine skeptic crowd, which has long used the potential for vaccine injuries and erroneous links to the development of neurological disorders like autism to further their cause.
    • “The group will also now specifically be tasked with reviewing new vaccine platforms such as mRNA shots, which have become a frequent bugbear in anti-vaccine rhetoric following the COVID-19 pandemic.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has, for the second time, turned back a medicine for a tough-to-treat skin cancer in a decision that marks a major setback for the therapy and its developer, biotechnology company Replimune.
    • “The agency on Friday rejected the treatment, vusolimogene oderparepvec or “RP1,” which had been under review for people whose advanced melanoma progresses despite treatment with a widely used cancer immunotherapy. In a letter made public Friday, the agency claimed that the review team, as well as multiple agency leaders and subject matter experts, determined the data are “insufficient to conclude substantial evidence of effectiveness.”
    • “The decision comes eight months after U.S. regulators spurned RP1, arguing that the company’s findings couldn’t be “adequately interpreted.” Replimune claimed to have been blindsided by the rejection and afterwards provided the FDA with additional information and analyses to boost its case. The agency, though, argued in its letter that its feedback to Replimune has remained consistent through years of communications and that its issues weren’t addressed.”
  • The Wall Street Journal relates,
    • “GSK withdrew its application for a drug touted last year by President Trump as a potential treatment for autism symptoms, just months after the company submitted it at the request of health officials.
    • “The U.K. drugmaker asked the Food and Drug Administration to pull its application for the drug leucovorin calcium because it doesn’t market the medicine, according to a regulatory filing posted Thursday. 
    • “The FDA had just approved leucovorin last month. Generic forms of the medicine will still be available. * * *
    • “GSK hadn’t sold the drug since 1999. At the request of the Food and Drug Administration, GSK said in September it would submit its application for patients with cerebral folate transport deficiency—a rare genetic condition with similarities to autism—in a move that allowed the agency to update the label for the drug and its generic counterparts. 
    • “FDA officials last month announced they had approved the drug for that condition based on a review of existing studies, but said in a call with reporters that they hadn’t found enough evidence to merit OK’ing the drug’s use to treat autism more broadly.
    • “Senior FDA officials said they examined scientific studies to see whether they could approve leucovorin to treat autism, but didn’t come up with enough strong scientific evidence to do so.
    • “A spokesman for HHS said GSK’s withdrawal on Thursday doesn’t affect generic versions of the drug, which already have updated labels for the genetic condition.”
  • Cardiovascular Business tells us,
    • :The U.S. Food and Drug Administration (FDA) is warning the public that certain sizing catheters from Indiana-based Cook Medical should no longer be used due to an increased risk of cracking or breaking.
    • “The agency’s warning covers specific lots of Cook Medical’s Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters and Beacon Tip Centimeter Sizing Catheters. These devices are used for a variety of angiographic procedures, aortic interventions, peripheral interventions and vascular interventions. They are made in a variety of sizes and multiple configurations.
    • “Potential adverse events that could result include increased procedural time, harms associated with device fragmentation/separation and vessel injury,” according to the FDA. “In a worst-case scenario, device fragmentation and separation could cause life-threatening harm or death.”
    • “At this time, the FDA noted, no serious injuries or deaths have been linked to this issue. The agency is still reviewing the situation.
    • “The FDA’s early alert can be read in full here. It also includes a full list of all affected product lots.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “Even as the US respiratory illness season continues to ebb, it remains deadly, with the Centers for Disease Control and Prevention (CDC) documenting 12 more pediatric deaths in its FluView update today. 
    • “So far this season, 139 children have died from the virus, and about 85% with a known vaccination status were unvaccinated. While the CDC has classified this flu season as moderate for adults, it’s been high-severity for children.
    • “For comparison, in the previous three flu seasons the CDC logged 187, 210, and 296 flu-related deaths for the complete season. The 289 pediatric deaths in 2024-25 was the most since the 2009-10 H1N1 flu pandemic.
    • “Only four jurisdictions were reporting moderate flu activity last week, and none saw high activity. Flu accounted for 8.2% of viral respiratory diseases, down from 9.8% the previous week. A total of 2,589 people were hospitalized, compared with 3,050 the week before. The proportion of outpatient visits for flu declined to 2.4% from 2.6% the previous week.” * * *
    • “The level of acute respiratory illness causing people to seek medical attention is very low. Rates of respiratory syncytial virus (RSV) remain elevated, but the virus is past peak in many areas of the country, the CDC said in its weekly respiratory virus activity update today.
    • “COVID-19 levels are low in most parts of the country, and viral wastewater concentrations are low for RSV and very low for COVID-19 and influenza A.” 
  • The American Hospital Association adds,
    • “The Utah measles outbreak has increased to 583 cases, the state’s Department of Health and Human Services reported April 7. Of those, 386 cases have been diagnosed this year. Nationwide, there have been 1,714 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 94% of cases are outbreak-associated and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.” 
  • Harvard Professor of Pediatrics Dr. David S. Ludwig opines in STAT News
    • “Targeting ultra-processed foods would make packaged foods less tasty and appealing, but no less fattening.
    • “Ironically, many products now emblematic of ultra-processed foods were developed in response to calls from nutrition scientists and government to replace dietary fat with carbohydrates, a misguided campaign that did more harm than good. We can’t afford another sweeping restructuring of the food supply based on imprecise interventions and uncertain science.
    • “Instead, focusing on processed carbohydrates offers a more precise and pragmatic solution, one that could invite collaboration with, rather than opposition from, the food industry.
    • “Delicious, calorie-rich food — whether home-prepared or packaged — isn’t the problem. What matters is how long we stay satisfied (satiety) relative to calories consumed. A 100-calorie snack or a sugary beverage isn’t better for our waistline than 200 calories from nuts if the lower-calorie option leaves us hungry and craving more soon after.
    • “By targeting the dietary drivers of weight gain, rather than misleading notions about food palatability and pleasure, we can have our (low-carb) cake and eat it, too.”
  • STAT News also tells us,
    • “With thousands of illegal e-cigarettes for sale in the U.S., both the Trump and Biden administrations have vowed to crack down on the illicit fruit- and candy-flavoredvapes that hold particular appeal to minors. But a new government report suggests law enforcement efforts by the Department of Justice lag far behind the scope of the problem. 
    • “Most DOJ enforcement actions between fiscal year 2022 and fiscal year 2025 — 50 out of a total of 88 — were to add the names of remote e-cigarette sellers to a list of unauthorized businesses, according to the report from the Government Accountability Office. The second-most common type of enforcement actions (20 out of 88) noted in the report were injunctions to stop legal violations. 
    • “The GAO report was focused on actions that involved the DOJ, so those tallies do not take into account enforcement actions like the seizure of more than 6 million illegal products by the Food and Drug Administration and U.S. Customs and Border Protection between 2024 and 2025. To put those seizures in context, a large seizure of $76 million worth of products in 2024 — 3 million vapes — equated to about 4% of China’s e-cigarette exports to the U.S. in a single month, said Steven Xu, an adjunct assistant professor at the University of Waterloo who studies e-cigarettes.
    • “Sen. Dick Durbin (D-Ill.), who requested the report, said it shows that much more work needs to be done to combat the public health threat posed by illegal vapes.”
  • Health Day informs us,
    • “Standard cognitive tests may fail to capture early brain changes in women 
    • “Women’s brains often show a steeper and more widespread decline than men’s when moving from mild impairment to Alzheimer’s
    • “Sex-specific standards may be needed to interpret brain scans and screening results accurately.”
  • and
    • “Cardiovascular health may impact fracture risk in women after menopause, according to a study published online March 27 in The Lancet Regional Health-Americas.” * * *
    • “Many of the same factors that protect your heart — regular physical activity, a balanced diet rich in calcium and vitamin D, not smoking and managing conditions like diabetes and high blood pressure — also help protect your bones,” Hossain said in a statement. “If you’ve been told you have intermediate or high cardiovascular risk, particularly if you are a postmenopausal woman, it may be worthwhile to talk to your doctor about bone health screening, given the many effective treatments available that reduce fracture risk.”

From the U.S. healthcare business front,

  • Beckers Payer Issues shares a boatload of Blue Cross Blue Shield updates.
  • Healthcare Dive reports,
    • “Menopause has come out of the shadows and into the public spotlight in recent years. Celebrities have become more eager to dish about hot flashes and night sweats, and a flurry of telehealth start-ups promising relief from a broad constellation of symptoms have given rise to a $17 billion menopause market.
    • “But demand for treatments still far outpaces the science, as persistent structural barriers confound the women’s health space. 
    • “People have taken up the charge and are trying to make an impact in a specific area,” said Kim Dalla Torre, an EY Global and Americas Health leader.” * * *
    • “More also needs to be done to raise women’s awareness that menopausal symptoms shouldn’t be something they need to tolerate in silence, Dalla Torre said. Some 80% of women experiencing these symptoms don’t reach out to their doctors for help, according to the Mayo Clinic. Drugmakers also need to play a role.” 
       
  • Cigna, writing in LinkedIn, tells us,
    • “Mental fitness is essential for stress management, resilience, and workplace productivity, helping employees achieve work/life harmony.
    • “When organizations truly care about mental fitness, employees feel more supported and valued—which leads to higher engagement, fewer days missed from work, and meaningful reductions in healthcare costs for everyone.
    • “By thoughtfully weaving together mental and physical wellness programs, organizations can nurture a more vibrant and supportive workforce—leading to lasting success, greater employee retention, and the ability to attract exceptional talent.”
  • Healthcare Innovation points out,
    • “Sentara Health’s navigators are trained professionals with expertise in behavioral health, community resources, and motivational interviewing, working closely with ED teams and patients.
    • “The program started with pilot phases at select hospitals, expanding to 10 sites over a year, with ongoing data collection to measure impact and guide future improvements.
    • “Early results indicate significant reductions in readmission rates, demonstrating the program’s effectiveness in connecting patients to appropriate community-based care.”
  • Radiology Business informs us,
    • “In a bid to offer more services outside of Manhattan, Weill Cornell Medicine is planning to build a $57 million new radiology clinic in Brooklyn.
    • “The New York City academic system officially applied for the necessary state Department of Health approvals on Monday. Located in South Brooklyn’s Bay Ridge neighborhood on 86th Street, the clinic is expected to include three MRI machines, a CT scanner and ultrasound and mammography offerings, Crain’s New York Business reported. 
    • “The outpatient radiology clinic will be housed inside the NewYork-Presbyterian Bay Ridge Primary Multispecialty center and marks a significant expansion for the hospital system outside of Manhattan.
    • “While it’s premature to talk about the services of this location, we are always striving to meet the healthcare needs of New Yorkers in their own neighborhood,” Robert J. Min, MD, radiology chair and president and CEO of the Weill Cornell Physician Organization, told Radiology Business by email April 9. “We are still in the planning stages and will share details in the coming months.”
    • “Weill Cornell hopes the new center will help alleviate demand for radiology services in Brooklyn and the surrounding communities, according to the state application. The project is part of a bigger push by Weill Cornell and NewYork Presbyterian to expand their outpatient footprint across the city, local news outlet Hoodline reported Thursday.” 

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, NIH, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump on Wednesday endorsed a two-part plan to quickly fund most of the Department of Homeland Security and then use a special procedure to pay for immigration enforcement with only GOP votes, stepping in to resolve a standoff between Republican congressional leaders.” * * *
    • “Congress could now pass a bill funding most of DHS that the Senate approved last week, and Trump set a goal of June 1 for funding the rest of the department using a process called budget reconciliation. The maneuver requires a simple majority for budget-focused bills, rather than the 60 votes typically required in the Senate, which Republicans control 53-47.
    • [Senate Majority Leader John] Thune [(R., SD)] and House Speaker Mike Johnson (R., La.), who had publicly disagreed over the best way to end the DHS shutdown, issued a joint statement backing Trump’s directive and saying they agreed on the two-step path to fully fund the department in “coming days.”
  • Healthcare Dive reports,
    • “Elevance avoided steep sanctions against its Medicare Advantage plans that were set to kick in on Wednesday, after the CMS granted the insurer an extension to make up for incorrect risk adjustment data reporting stretching back years.
    • “Earlier this year, the CMS notified Elevance that it planned to prevent the insurer’s MA plans from enrolling new members, along with other sanctions, starting on March 31 after finding that Elevance failed to comply with federal data submission requirements. Elevance asked regulators for more time to comply, and the CMS granted the company’s request in mid-March, according to a disclosure from Elevance.
    • “Elevance now has until May 30 to correct its data reporting before sanctions kick in. The CMS also exempted several of Elevance’s MA plans that weren’t impacted by the noncompliance from the potential penalties.”
  • The Labor Department issued a “Frequently Asked Question (FAQ) regarding implementation of certain provisions of Title I (the No Surprises Act)(1) of division BB of the Consolidated Appropriations Act, 2021. This FAQ has been prepared jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM).”
    • The FAQ 73 concerns an ongoing Qualifying Payment Amount dispute long pending before the U.S. Court of Appeals for the Fifth Circuit.
    • “Q1: Are the Departments and OPM extending the enforcement relief regarding the use of QPAs announced in FAQs Part 71?
      • “Yes. The Departments and OPM extend the exercise of enforcement discretion, originally provided in FAQs Part 62 and extended in FAQs Parts 67, 69, and 71, under the relevant No Surprises Act provisions for any plan or issuer, or party to a payment dispute in the Federal IDR process, that uses a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026, the first day of the calendar month that begins after 6 months from the issuance of these FAQs. This exercise of enforcement discretion applies to QPAs for purposes of calculating patient cost sharing, providing required disclosures with an initial payment or notice of denial of payment,(14) and providing required disclosures and submissions under the Federal IDR process.
      • “HHS similarly extends its exercise of enforcement discretion under the relevant No Surprises Act provisions for a provider, facility, or provider of air ambulance services that bills, or holds liable, a participant, beneficiary, or enrollee for a cost-sharing amount based on a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026.”
  • Per an OPM March 31, 2026, news release,
    • “Today, the Office of Personnel Management (OPM) announced the President’s Commission on White House Fellowships is now accepting applications for the 2026-27 class of White House Fellows.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS), through the CMS Innovation Center, announced that organizations participating in certain Innovation Center models may begin offering a new Substance Access Beneficiary Engagement Incentive (BEI) starting April 1, 2026. Through this optional incentive, eligible hemp-derived products can be incorporated into patient care plans under clinician guidance, consistent with model requirements and applicable law.
    • “This milestone reflects the Administration’s broader efforts to expand access to innovative, patient-centered care. It also aligns with President Trump’s Executive Order supporting research and innovation related to hemp-derived products. It marks a meaningful step as CMS begins testing how emerging care tools can be integrated into coordinated care to improve outcomes and quality of life. 
    • “CMS is committed to innovation that meets patients where they are while maintaining strong safeguards and clinical oversight,” said CMS Administrator Dr. Mehmet Oz. “Under the President’s leadership, we’re expanding the tools available to improve patients’ health while generating important insights into how providers can use these tools safely and effectively in real-world care settings.” * * *
    • “More information about the Substance Access Beneficiary Engagement Incentive, including eligibility criteria and program requirements, is available at: https://www.cms.gov/priorities/innovation/substance-access-beneficiary-engagement-incentive.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services March 30 announced that C2C Innovative Solutions will replace Maximus in reviewing and processing appeals of adverse organization determinations and reconsiderations made by Medicare Advantage plans as of May 1. Maximum will continue to process appeals requests received on or before April 30. CMS said there will be a short period when both Maximus and C2C are issuing decisions. Updates on procedures for submitting appeal case files and other communications will become available on C2C’s website beginning April 1.” 
  • The Wall Street Journal informs us,
    • “The latest Census Bureau data show the broad effects of a big immigration slowdown in the U.S., and a lot more.
    • “The numbers for the year through June 2025 also show fewer people bailing on America’s tech epicenter, a modest Midwest rebound and rising appeal for small southern metros.” 

From the Food and Drug Administration front,

  • In the biggest healthcare news of the day, the Wall Street Journal reports,
    • “The weight-loss pill wars start now. 
    • “Eli Lilly’s once-daily pill for weight loss got approval from U.S. drug regulators Wednesday. The all-clear sets up a battle with rival Novo Nordisk, which has been selling a pill version of its Wegovy since the start of this year.
    • “The Wegovy pill has had one of the best drug launches in history. Now that the Food and Drug Administration has approved its pill, Lilly will seek to overtake the rival, and further its dominance of the booming $70 billion-plus market for weight-loss and diabetes drugs known as GLP-1s.
    • “It will be a battle royal for GLP-1 pill leadership between Novo and Lilly,” Leerink Partners analyst David Risinger said.
    • “Lilly has won a weight-loss fight before: While Novo Nordisk pioneered the use of GLP-1 drugs for weight loss with its Wegovy and Ozempic weekly injections, Lilly’s Zepbound and Mounjaro injections now outsell them.
    • “Yet Novo Nordisk plans to avoid the mistakes that hurt it during the last round, and will seek to hold on to its early lead by emphasizing the effectiveness of its pill.
    • “Analysts are betting on Lilly, expecting its pill, named Foundayo, to generate about $21 billion in global sales by 2030, compared with $4 billion for the Wegovy pill, according to pharmaceutical commercial intelligence firm Evaluate.”
  • Fierce Pharma relates,
    • “The FDA has delayed its target decision date for Orca Bio’s blood cancer cell therapy candidate Orca-T by three months to July 6.
    • “The review extension comes after the company submitted additional data related to chemistry, manufacturing and controls (CMC) a couple of weeks ago upon request by the agency, Orca Bio’s CEO Nate Fernhoff, Ph.D., told Fierce.
    • “Fernhoff wouldn’t specify the exact nature of the FDA’s questions but said the company doesn’t believe “any of these to be fundamental or unaddressable.”
  • MedTech Dive tells us,
    • “Distalmotion has submitted a 510(k) application to expand the label of its Dexter robotic surgery system in the U.S., the company said Wednesday.
    • “The company aims to expand use of Dexter in gynecological indications, strengthening its push to support ambulatory surgical centers that want to perform more outpatient procedures.  
    • “Distalmotion has identified ASCs, which may have less space, resources and infrastructure than hospitals, as sites of care where Dexter could have an advantage over existing surgical robots.”
  • Cardiovascular News informs us,
    • “The U.S. Food and Drug Administration (FDA) has confirmed a new recall of the purge cassettes sold with certain Johnson & Johnson MedTech Impella heart pumps. The alert covers individually packaged Generation 1 Purge Cassettes as well as the ones sold with certain Impella RP, Impella 2.5, Impella CP, Impella CP with Smart Assist, Impella 5.0 and Impella 5.5 with Smart Assist heart pumps. 
    • “The FDA issued this recall due to a risk of the purge cassettes leaking. Purge cassettes play a critical role in patient care, delivering a rinsing fluid to the catheter that prevents blood from flowing back into the motor.
    • “A purge leak may lead to low purge pressure if it goes unaddressed,” according to Johnson & Johnson MedTech. “This can lead to biomaterial ingress, which may lead to an unexpected pump stop. A pump stop may result in a loss of hemodynamic support and lead to patient death.”
    • “The leaks have been linked to four serious injuries and no deaths.”

From the judicial front,

  • ABHW reports,
    • “The Association for Behavioral Health and Wellness (ABHW), the national voice for payers that manage behavioral health insurance benefits for 200 million people, issued the following statement in response to the Trump Administration’s announcement that they will issue a new proposed rule on the Mental Health Parity and Addiction Equity Act (MHPAEA), including anticipated significant revisions to the provisions of the Rule, as ABHW had requested. The Administration has indicated through court documents that it intends to include this rulemaking on the 2026 Spring Regulatory Agenda, and to issue a notice of proposed rulemaking no later than December 31, 2026.”

From the public health and medical / Rx research front,

  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have identified a novel, highly potent opioid that shows potential as a therapy for both pain and opioid use disorder. In a study published in Nature, the team observed the new drug’s effect in laboratory animals. They showed that it has high pain-relieving effects without causing respiratory depression, tolerance or other indicators of potential for addiction in humans.
    • “Opioid pain medications are essential for medical purposes, but can lead to addiction and overdose,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “Developing a highly effective pain medication without these drawbacks would have enormous public health benefits.”
    • “The team investigated formulations of an understudied class of synthetic opioid compounds, known as nitazenes. Nitazenes selectively engage mu-opioid receptors, primary targets for opioid drugs in the brain and peripheral nervous system. However, nitazenes had been shelved in the 1950s due to their excessive potency. The scientific team revisited this class of compounds with a focus on harnessing their selectivity for the mu opioid receptor and engineering new nitazenes with a safer pharmacological profile.
    • “Our goal was to study the profile, or pharmacology, of these drugs,” said Michael Michaelides, Ph.D., senior author and NIDA investigator. “We wanted to decrease the potency and create a potential therapeutic. What we discovered exceeded our expectations.”
  • STAT News reports,
    • “Few things will give a man as much of an insight into the female body as growing up with sisters. Painful, irregular periods, body hair, skin trouble: Al Barrus, a 43-year-old veteran and communications specialist from New Mexico, heard all about it growing up, the only male of three siblings. He’s also known for a while that one of his sisters had been diagnosed with polycystic ovary syndrome, an endocrinological disorder and leading cause of infertility associated with a range of issues including high androgen levels, insulin resistance, and enlarged ovaries. His other sister, too, had some PCOS symptoms. 
    • “Recently, he’s begun to wonder: Could he have it, too? 
    • “Not exactly PCOS but a “male form.” Where women with PCOS’ levels of androgen are too high, his are too low; rather than hirsutism (excess body hair), he has sparse body and facial hair and began going bald as a teenager. He has other issues similar to the ones that can appear in women with PCOS: high levels of the hormone prolactin, suspected insulin resistance, obesity, mental health struggles.” * * *
    • “It took more than a decade, but at last, there is a name, though it is still tightly under wraps “pending submission to a journal for publication,” said Robert Norman, a professor emeritus of reproductive and periconceptual medicine at Adelaide University and one of the experts who worked on selecting a new name. He declined an interview request: “I think you would find it frustrating talking with us when we are not going to reveal the new name yet!” 
  • The American Hospital Association News relates,
    • “The Centers for Disease Control and Prevention has temporarily paused rabies and pox virus testing, according to an update on its website March 30. The pox virus family consists of several viruses, including smallpox and mpox. The CDC typically confirms infections for rabies and pox viruses, among several other infectious diseases.”
  • MedPage Today tells us,
    • “Significant incidental findings detected on low-dose CT lung cancer screening were associated with an increased risk of an extrapulmonary cancer diagnosis over the following year.
    • “Risk differences were significantly higher for urinary cancers, as well as lymphoma and leukemia.
    • “Certain significant incidental findings should be assessed as potential indicators of undiagnosed cancers, researchers said.”
  • Healio informs us,
    • “Incidence of fractures among women begins to rise at age 35 years and increases dramatically starting at age 45 years, whereas men have their highest rates of fracture at age 35 to 45 years, according to data from the UK Biobank.
    • “Our findings reveal a previously underrecognized trajectory of increasing fracture risk in women beginning as early as age 35 years old, with a marked acceleration from the mid-40s,” Catherine Rolls, MSc, research associate in the musculoskeletal research unit and translational and applied research group at University of Bristol in the U.K., and colleagues wrote in a study published in Journal of Bone and Mineral Research. “This female-specific pattern resembles the postmenopausal risk profiles traditionally seen in older populations and suggests that skeletal vulnerability begins earlier than often assumed.”
  • Health Day points out,
    • “Teenagers might be known for being night owls, but they’ll be healthier if they can get to bed earlier, a new study says.
    • “Teens who stay up late and sleep the morning away are more likely to eat more and be less physically active, especially when school is in session, researchers report in the April issue of the journal Sleep Health.
    • “Sleep timing — when teens go to bed and wake up — had the biggest influence on sedentary and eating behavior in teens,” senior researcher Julio Fernandez-Mendoza, a professor of psychiatry and behavioral health at Penn State College of Medicine, said in a news release.
    • “It’s something parents need to pay attention to — and protect — during critical developmental years like adolescence,” he said.”
  • Per MedTech Dive,
    • “Medtronic said it will support a new study of its Symplicity Spyral procedure in patients with uncontrolled high blood pressure and multivessel artery disease who are undergoing percutaneous coronary intervention. Global guidelines indicate patients with both conditions need more aggressive hypertension management, the device maker said this weekend at the American College of Cardiology’s annual meeting.
    • “Medtronic’s Symplicity Spyral renal denervation device won Food and Drug Administration approval in late 2023 to treat patients whose high blood pressure cannot be controlled by drugs. The new study, called EMBRACE, will evaluate renal denervation performed in the same procedure as PCI, a treatment to remove plaque buildup and open blocked coronary arteries.
    • “Separately, Medtronic released results from a pooled analysis of the SPYRAL HTN ON and OFF MED trials showing that patients who underwent a renal denervation procedure to improve their blood pressure had a significantly lower rate of hypertensive emergencies (40%) at three years than those who received a sham treatment.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The combination of technology and alternative care options is slowing the growth rate of healthcare spending.
    • “In January, the Centers for Medicare and Medicaid Services said healthcare expenditures rose 7.2%, to $5.3 trillion, in 2024. Healthcare spending accounted for 18% of gross domestic product in 2024, less than the 21.2% the agency projected.
    • “Advances in care delivery, reduced pricing on some treatments and payer restrictions on care utilization drove down spending, according to a recent study by public policy organization Brookings Institute. 
    • “The healthcare spending growth rate relative to GDP from 2010 to 2024 is the lowest in a 14-year period since 1960, the study said. 
    • “While we’re documenting that the healthcare cost curve has bent and we think that there are reasons that it will continue to be bent, it could still bend more,” said Lev Klarnet, one of the study’s authors and a doctoral student in business economics at Harvard University.
    • “Here are three takeaways from the research.
      • Cost sharing, prior authorizations reduce demand
      • Outpatient procedures are saving money, and
      • “Technology is lowering costs by improving health.”
  • and
    • “The Leapfrog Group will expand its rating system for ambulatory surgery centers.
    • “Starting in July, Leapfrog plans to use publicly reported Centers for Medicare and Medicaid Services data to compare safety and quality measures across nearly 4,000 ASCs, similar to how the independent watchdog group rates hospitals, according to a Tuesday news release. 
  • Beckers Payer Issues reminds us,
    • “For the first time, payers must publicly post data on how often they deny prior authorization requests, how quickly they process them and how often denials are overturned on appeal. The first reports are due March 31 under a rule CMS finalized in 2024.” 
  • Fierce Healthcare tells us,
    • “It’s been seven years since the American Medical Association (AMA) launched its Joy in Medicine program to address physician burnout. 
    • “The issue is far from resolved, with burnout peaking during the COVID-19 pandemic. Recent estimates have found that more than half of surgeons are still burned out. Amid pressing financial challenges and as organizations struggle to recruit clinicians, the need for joy in medicine has never been more pressing.
    • “The AMA’s voluntary program is meant to serve as a guide to health systems looking to assess and address their institutions’ levels of burnout. Organizations must apply and it is free to participate. About 1,800 organizations have participated to date.”
  • BioPharma Dive informs us,
    • “Merck and Co. has signed an agreement with California-based Infinimmune to develop multiple antibodies for various disease targets, the companies announced Tuesday.
    • “Per deal terms, Merck could load Infinimmune with up to $838 million in upfront and milestone payments if any of the drug candidates make it into clinical testing and onto the market. Neither company disclosed how much was offered as an upfront payment. Merck will hold exclusive rights to develop and commercialize drugs that are discovered through the collaboration.”
  • Beckers Hospital Review shares “the big bets 20 pharmacy leaders are making right now.”
  • The Wall Street Journal points out,
    • “The nation’s costliest autism therapy provider will shut down by mid-May, the company’s human resources chief said in an email to employees one week after the state of Indiana said it would bar the firm from billing Medicaid.
    • “The autism-therapy provider, Piece by Piece Autism Centers, received $340,000 in Medicaid payments per patient in 2023, the highest level in the country, The Wall Street Journal reported last month in an article examining how some providers had outpaced regulators in their fast-growing businesses.
    • “Once Piece by Piece—which state officials have said abused the taxpayer-funded program for low-income people—closes, its centers will be operated by a rival autism-therapy provider, Applied Behavior Center for Autism, emails show. Applied Behavior Center settled federal civil fraud allegations over billing issues just three years ago without admitting wrongdoing, the Justice Department announced at the time.”