Tuesday report

Medical / Rx research

Tuesday report

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

From Washington, DC,

  • STAT News reports,
    • “The four health system CEOs summoned before [the House Ways and Means Committee] Tuesday likely breathed sighs of relief early in the hearing, when it became clear they had friends in the audience. 
    • “Instead, committee members largely blamed the other party’s health care policies for driving U.S. health care prices to levels inaccessible to many Americans.” * * *
    • “A topic that came up frequently was hospitals’ practice of charging facility fees at their outpatient clinics, rendering the same services much more expensive when provided there compared with independent physician clinics. 
    • “Rep. Jodey Arrington (R-Tex.) said that both Republican and Democratic presidents have included site-neutral payment reform, which would equalize Medicare reimbursement to hospital-owned and physician-owned outpatient clinics, in their budgets, “but we don’t do jack squat about it.” He asked the CEOs to raise their hands if they supported site-neutral payment reform. None did. 
    • “Smith echoed that sentiment, noting that Congress, including his committee, has tried to implement site-neutral payments. “But every time we try to advance these so-called site-neutral policies, big hospitals fight us tooth and nail,” he said.”
  • AHIP notes,
    • “Hospital costs account for more than 40 cents of every premium dollar – more than any other category – and many hospital systems continue to raise their prices at rates that dwarf inflation while also sticking patients with high bills with layers of opaque fees. Instead of blaming others, the hospital industry should stop their anticompetitive consolidation, opaque billing practices and unaffordable price hikes that continue to drive Americans’ premium costs higher.” —Chris Bond, AHIP Spokesperson” * * *
    • “Health plans are doing everything in their power to shield Americans from the high and rising costs of medical care and are committed to working constructively with policymakers to advance common-sense, bipartisan reforms. Policymakers have a clear opportunity to act, including:
      • “Protecting consumers with site-neutral payment reforms to level the playing field on prices, reduce patient cost-sharing, and lower premiums — saving more than $170 billion over 10 years.
      • “Promoting greater competition among hospitals by blocking anticompetitive hospital mergers.
      • “Requiring price transparency so patients and employers can see what they’re actually paying for.”
  • The American Hospital Association News adds,
    • “The AHA submitted a statement for the record to the House Ways and Means Committee for its April 28 hearingwith health system CEOs.
    • “In the statement, the AHA outlined steps to improve health care affordability while warning against policies that could limit patient access to care.
    • “We understand the importance of making sure high-quality care is affordable and accessible,” AHA stated. “As such, hospitals have long been leaders in advancing meaningful solutions to complex health care challenges, including the issue of affordability. That spirit continues today as hospitals across the country work to reduce the cost of care by improving efficiency, embracing innovative technologies and redesigning how services are delivered. Many are investing in preventive care and care coordination programs that help patients manage chronic conditions, avoid unnecessary hospital visits and stay healthier at home. These efforts not only improve patient outcomes but also lower overall costs for patients, families and the health care system.”
  • Fierce Healthcare offers more details on the hearing and also reports,
    • “The National Academy of Medicine recently kicked off its second Change Maker Accelerators program, aimed at aiding healthcare organizations in implementing and measuring well-being efforts.
    • “The NAM’s voluntary yearlong program builds on its 2022 National Plan for Health Workforce Well-Being framework. Organizations must apply, and participation is free. 
    • “The program is part of NAM’s broader Change Maker campaign, which works to advance the national plan’s priority areas. About 520 organizations have become members since the campaign launched in October 2023.”
  • KFF Health News explores how the $50 billion Federal Rural Health Fund will be distributed.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The U.S. Food and Drug Administration seeks to accelerate clinical trials of new medicines by using artificial intelligence to streamline the laborious process of collecting and submitting study data.
    • “Typically, medical centers involved in clinical trials pull study data from electronic-health records and enter them manually into a data-capture system. Then, the drug company developing the medicine reviews the data and submits them to the FDA.
    • “The FDA this summer plans to pilot an approach that would upend this practice, which hasn’t changed much in decades. Through the program, AI would extract data directly from electronic records so they can be submitted in real-time to both the FDA and the pharmaceutical company. 
    • “If successful and adopted widely, the new approach could speed drug development and help the U.S. compete with other nations making a strong push into biotechnology, officials said.”
  • Fierce Pharma relates,
    • “After breaking through the blockbuster sales threshold in 2025, AstraZeneca’s three-in-one inhaler Breztri Aerosphere has passed another crucial milestone as it chips in on the British drugmaker’s goal to reach $80 billion in revenues by 2030. 
    • “On Tuesday, the FDA approved Breztri in its second indication, clearing the triple combination therapy of budesonide, glycopyrrolate and formoterol fumarate as a maintenance treatment for asthma in adults and kids ages 12 and older. Breztri was first greenlit in the U.S. in 2020 as a maintenance treatment for chronic obstructive pulmonary disease (COPD). 
    • “The new nod will unlock a substantial market for Breztri, which is one of several respiratory products driving significant sales ambitions at AstraZeneca. Last year, the drug surpassed the billion-dollar sales threshold for the first time, with revenues growing (PDF) 22% at constant currencies to nearly $1.2 billion.”
  • and
    • “Earlier this year, when the FDA asked Amgen to pull its rare disease drug Tavneos from the market, the California drugmaker denied the request. Now, the U.S. regulator is applying more pressure.
    • “The FDA’s Center for Drug Evaluation and Research (CDER) has proposed to withdraw the approval of Amgen’s oral medicine, saying new information indicates the data was “manipulated” to facilitate its green light.
    • “CDER said in a letter (PDF), which also called out Amgen’s subsidiary ChemoCentryx, that Tavneos is not effective and that its application for approval to treat ANCA-associated vasculitis included untrue statements. In addition, CDER noted that it is “increasingly concerned about the safety of Tavneos,” pointing to cases of serious drug-induced liver injury (DILI).
    • “The FDA said that Amgen’s options are to pull the drug from the market or request a hearing.
    • “The company is evaluating its next steps, an Amgen spokesperson said in an email.
    • “We remain confident in Tavneos as a safe and effective medicine, supported by years of clinical data and real-world evidence,” the spokesperson wrote. “Our perspective on the benefit-risk profile of Tavneos differs from the Agency’s.”

From the judicial front,

  • Bloomberg Law reports,
    • “A New Jersey federal judge accepted Purdue Pharma LP’s multibillion-dollar criminal plea deal with the US government on charges related to its dissemination of addictive opioid products, a critical step for the OxyContin maker’s $7.4 billion bankruptcy plan.
    • “Judge Madeline Cox Arleo of the US District Court for the District of New Jersey on Tuesday apologized to opioid addiction victims and their family members as she accepted Purdue’s 2020 guilty plea for misleading federal regulators about its efforts to prevent drug diversion and paying illegal kickbacks to prescribing doctors.
    • “It is the best choice that I have and I am satisfied it is the best choice at this juncture,” she said. “I wish there was more I was empowered to do.”
    • “The agreement with the Department of Justice allows Purdue to consummate its Chapter 11 bankruptcy plan, largely structured around a deal with the company’s Sackler family owners to pay at least $6.5 billion to compensate personal injury victims and fund opioid abatement efforts by local governments across the country.
    • “The sentencing hearing was put on hold for several years as Purdue’s bankruptcy was prolonged by appeals over provisions releasing the Sacklers from legal liabilities related to the company’s production and sale of addictive opioids.
    • “A revised version of the plan, approved by a New York bankruptcy judge in November, gives creditors the ability to opt out of releasing claims against Sackler family members in exchange for a smaller settlement distribution.”
  • Healthcare Dive relates,
    • “The frequency of medical liability lawsuits filed against doctors is falling over time but they are still common, according to a research report released this week from the American Medical Association.
    • “Risk of lawsuits is higher among certain specialities and increases the longer doctors practice medicine, the AMA reported.
    • “In a separate AMA report, medical liability insurance is also getting more expensive for some doctors, with premiums growing at consistent rates not seen in two decades. The risk of being sued “not only challenges physicians but it increases practice expenses, reinforces defensive medical practices, and drives up health care costs for patients and families,” Dr. Bobby Mukkamala, AMA president, said in a statement.”

From the public health and medical / Rx research front,

  • The Washington Post tells us five things that OB/GYNs want you to know about perimenopause.
    • “Estrogen and progesterone are the main drivers”
    • “It can last for months or years”
    • “Symptoms are wide-ranging, but a few are very common”
    • “There’s no specific test to diagnose it”
    • “The right treatment can be life-changing”
  • MedPage Today reports,
    • “About a quarter of survey respondents who met USPSTF eligibility criteria were up to date with lung cancer screening in 2024 — an increase in prevalence of 6 percentage points since 2022.
    • “Lung cancer screening rates were low compared with those for other cancers, including colorectal, cervical, and breast cancers.
    • “Up-to-date prevalence was uneven depending on age, race and ethnicity, and insurance status.”
  • Healio relates,
    • “Extensively drug-resistant Shigella is on the rise in the United States, according to data published by the CDC.
    • “Shigella is a bacterium that can be sexually transmitted and causes infectious diarrhea. The new study published in MMWR found that among nearly 17,000 Shigella isolates submitted to a CDC surveillance network, the proportion of extensively drug-resistant (XDR) isolates rose from 0% in 2011 to 8.5% in 2023. Around one-third of patients with XDR Shigella ended up hospitalized.” * * *
    • “Shigella causes an estimated 450,000 infections each year nationwide, making it a leading cause of diarrheal illness, according to the CDC. Common symptoms of the infection include diarrhea, fever, stomach pain and experiencing a feeling to pass stool when bowels are empty. 
    • “Meanwhile, Jason E. Zucker, MD, assistant professor of medicine at Columbia University Medical Center,  said most shigellosis cases will resolve on their own. He also said the rise of XDR Shigella “should prompt a broader conversation about sexual health, make sure the patient is up-to-date on STI screening, discuss [pre-exposure prophylaxis] if they’re not already on it and assess whether they’re connected to HIV prevention or care.”
  • The latest post of NIH Research Matters covers the following topics:
    • AI tool predicts patients at risk of intimate partner violence
      • “A new artificial intelligence tool can predict patients who are likely to experience intimate partner violence years before they seek help. 
      • “The tool may eventually help health care providers identify patients at risk of intimate partner violence and provide early interventions.”
    • Weakened gut-brain connection may contribute to memory loss
      • “Researchers found that changes to gut bacteria in aging mice hindered communication from the gut to the brain and led to worse performance on memory tasks.
      • “If these results hold true in humans, they could inspire treatments to prevent, reduce, or even reverse age-related cognitive decline.”
    • Boosting the immune response to brain cancer
      • Stopping certain immune cells from using fructose for fuel enhanced the immune response to brain cancer in mice.
      • The results point to a way to make immunotherapies more effective for a form of cancer that is often resistant to their effects.
  • Cardiovasular Business tells us,
    • “Treating patients with a sirolimus-eluting balloon (SEB) during percutaneous coronary intervention (PCI) is a safe, effective alternative to traditional stenting, according to new data presented at the SCAI 2026 Scientific Sessions and CAIC-ACCI Summit in Montréal, Canada.
    • “Interventional cardiologists typically use a drug-eluting stent (DES) during PCI to keep the artery permanently open. Leaving these stents in a patient’s artery can lead to complications, however, and the Selution SLR SEB from Cordis was designed to help keep that artery open without a stent being left behind. The Selution SLR SEB is a drug-coated balloon that provides patients with a sustained release of sirolimus over time thanks to tiny “MicroReservoirs.” The Selution SLR SEB was previously the topic of two late-breaking studies at TCT 2025 in San Francisco. Both trials linked the device to potential benefits for patients undergoing PCI.” 
  • MedTech Dive discusses,
    • Four studies to know from Heart Rythm Society’s 2026 conference.
    • Boston Scientific, Abbott and Medtronic shared new cardiac device data at the annual Heart Rhythm Society meeting, where market share shifts in pulsed field ablation were on analysts’ minds.
  • BioPharma Dive lets us know,
    • “Boehringer Ingelheim said its dual-acting obesity shot succeeded in a Phase 3 trial, announcing Tuesday that the therapy, survodutide, helped enrollees who received it lose significantly more weight than those who got a placebo.
    • “Notably, the shot, which Boehringer licensed from Zealand Pharma, also showed signs of helping study participants reduce weight while preserving muscle. That purported benefit could address a weakness of Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, both of which have been shown to lower lean body mass along with fat.  
    • “In notes to clients following the announcement, Wall Street analysts described survodutide’s weight loss effects as comparable to Wegovy but short of what’s been seen in testing of Zepbound. Multiple analysts are also awaiting more details on the drug’s side effects as well as data from a trial in the liver disease MASH before making further judgments about its commercial potential.”

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

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. recorded a net loss of more than $1.9 billion in 2025, a sharp reversal from the prior two years, according to regulatory filings.
    • “The Chicago-based organization, which operates the Blue Cross and Blue Shield plans in Illinois, Montana, New Mexico, Oklahoma and Texas, posted a net income of $659 million in 2024 and $1.4 billion in 2023.
    • “HCSC reported total revenue of $66.8 billion in 2025, up from $62.8 billion the prior year. Benefit expenses, however, rose to $63.1 billion from $57 billion, and the company’s net underwriting loss widened to $3.5 billion from $572 million in 2024. HCSC attributed membership and revenue growth to its purchase of the Cigna Group’s Medicare and CareAllies businesses for $3.3 billion last year.
    • “2025 was affected by headwinds consistent across the managed care industry associated with elevated utilization of healthcare services and higher acuity levels caused by more complex health needs across all of our lines of business,” an HCSC spokesperson told Becker’s.
    • “The company has 27.3 million members and managed $150.4 billion in medical spend in 2025.”
  • and
    • “Blue Cross and Blue Shield of Alabama posted a net loss of $3.2 million in 2025.
    • “The insurer saw its profit fall to $18 million in 2024 after posting $368.6 million in net income in 2023, according to financial data filed with the National Association of Insurance Commissioners.
    • “BCBS Alabama reported total assets of $6.2 billion at the end 2025, with capital and surplus of $3.6 billion. Medicare was the company’s largest line of business by direct premiums written at $1.5 billion, followed by the Federal Employees Health Benefits program at $1.2 billion, Medicare supplement at $207.7 million, dental at $158.7 million, and vision at $15 million.”
  • and
    • “Blue Cross Blue Shield of Arizona recorded a net loss of $335.2 million in 2025, according to regulatory filings.
    • “The insurer posted a loss of $162.2 million in 2024 and $85.4 million in net income in 2023.
    • BCBS Arizona reported total assets of $2.68 billion as of year-end 2025, with capital and surplus of $1.03 billion. The Federal Employees Health Benefits program was the company’s largest line of business by direct premiums written at $1.02 billion, followed by dental at $193.6 million, Medicare supplement at $27.9 million, and Medicare at $5.1 million.”
  • Healthcare Dive adds,
    • “Centene raised its 2026 profit guidance after successfully wrestling down medical costs in the first quarter.
    • “The St. Louis-based payer posted adjusted earnings per share of $3.37 in the quarter, well above analysts’ consensus expectations of about $2.20 to $2.30 as rate hikes offset membership losses.
    • “Companies generally argue that adjusted results are a better indicator of a company’s performance, as they exclude factors outside of a company’s control. But even when filtered through the U.S.’ default accounting standards, or unadjusted, Centene’s top and bottom-line results remained positive.
    • “In the first quarter, the insurer brought in net profit of $1.5 billion, up 18% year over year, on revenue of $49.9 billion, up 7% year over year.”
  • BioPharma Dive relates,
    • “Pfizer has reached settlements with a trio of drug manufacturers that’ll extend the patent protection for one of its best-selling medicines.
    • “In a short statement Tuesday, Pfizer said it has cut deals with Dexcel Pharma, Hikma Pharmaceuticals and Cipla. All three companies are seeking to launch generic versions of tafamidis, the active ingredient in a blockbuster rare disease medicine Pfizer sells as Vyndamax. Pfizer sued all for patent infringement, aiming to delay their arrival.  
    • “The agreements announced Monday ensure that tafamidis’ monopoly will hold until early next decade. Pfizer had anticipated that tafamidis’ exclusivity might expire in 2028 and prepared investors for a “significant decline” in U.S. revenues over the next few years. The settlement, though, extends tafamidis’ patent life through June 1, 2031, pending the outcome of other litigation. Drug sales in the U.S. should now “remain relatively stable” from 2028 through the middle of 2031, the company said.” 
  • Fierce Healthcare points out,
    • “Solace Health, a patient advocacy platform, is expanding insurance coverage to most major health plans, including UnitedHealthcare and Anthem Blue Cross Blue Shield. 
    • “Solace previously connected Medicare and Medicare Advantage patients to its services, which are now also available to many commercially insured patients. Other commercial plans that are now partners were not specified in a press release. Solace pairs each patient with a dedicated healthcare advocate who helps with care navigation.
    • “The healthcare system is complex and yet patients are often expected to coordinate their own care, interpret advice, manage records and resolve billing issues. One 2025 study found that over 60% of U.S. adults demonstrated inadequate health literacy. Solace aims to close this gap.”
  • and
    • “While some healthcare companies are testing out agentic AI tools, CCS is betting big on the technology as it developed an enterprise-wide, multi-agent network across its chronic care operations.
    • “The company, a provider of chronic care management and home-delivered medical supplies, has rolled out an agentic AI solution, dubbed CeeCee, that’s designed to streamline the patient experience, improve medical supply workflows and boost operational efficiency, executives said.
    • “CeeCee can autonomously resolve routine patient interactions, speed up access to chronic care supplies and support personalized patient experiences.” 
  • MedCity News adds,
    • “Issues with deployment and scaling are the real barriers holding back healthcare AI from delivering value, according to leaders at AI companies Nvidia and Hoppr.
    • “That’s why they’re shifting their focus away from building standalone models and zeroing in on the infrastructure needed for those models to actually be used in clinical practice. Hoppr has built an AI foundry that uses Nvidia’s computing and foundation models — an offering the partners say gives developers access to tools for launching medical imaging AI more easily at scale.
    • “The foundry aims to help providers develop, validate and then deploy their own AI models without having to start from scratch, said Hoppr CEO Khan Siddiqui.
    • We’re providing the platform where health systems, radiology practices and med device companies can now build their fine-tuned models very quickly and deploy them very quickly in their practice or in their product,” he explained.
    • “Hospitals no longer need huge amounts of data or infrastructure to create their own models because Hoppr and Nvidia pre-train their foundation models on massive datasets, he pointed out. In the past, providers needed to purchase massive datasets containing about 100,000 patient records to train AI models, but pre-trained foundation models allow hospitals to shape models using much smaller datasets, sometimes containing just hundreds of records, Siddiqui stated.
    • “The foundry’s goal is to make custom, localized AI development more feasible for providers, he declared.
    • “The focus is on increasing imaging AI models so that providers can embed specialized tools directly into radiology and diagnostic workflows rather than relying on one-size-fits-all solutions, Siddiqui noted.”

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

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • The House Ways and Means Committee will hold a hearing with health system CEOs on April 28, 2026, at 10 am ET.
  • Roll Call offers more details on this week’s activities on Capitol Hill.
  • Federal News Network interviews NARFE Staff Vice President John Hatton about OPM’s ill-advised health claims data warehouse and the Postal Service’s decision to suspend making contributions toward their employee’s retirement benefits due to its cash woes.

From the public health and medical / Rx research front,

  • Health Exec reports,
    • “The more you maintain good physical fitness from your mid-40s to your mid-60s, the likelier you are to add years to your life and life to your later years. 
    • “So conclude researchers at Texas Tech University Health Sciences Center who tracked cardiorespiratory health in around 25,000 adults from midlife through elder stages. 
    • “The team, led by Clare Meernik, PhD, MPH, assessed participants’ fitness using a treadmill test until age 65. From that point on, the researchers used Medicare data to watch for and record the onset of 11 major chronic conditions such as heart disease, diabetes, kidney disease and cancer.
    • “The Journal of the American College of Cardiology published the results April 21.”
  • The FEHBlog noted on Friday that tick bites are increasing in the U.S. The Washington Post offers relevant advice. “Experts explained what to do if you find a tick attached to your skin, including how to remove it and document it, and when to seek medical advice.”
  • Building on another FEHBlog post from Friday, the Wall Street Journal explains what heart valve patients need to know before treatment.
  • Cardiovascular Business adds,
    • “New-onset postoperative atrial fibrillation (POAF) remains the most common complication following cardiac surgery, typically developing within four days of treatment. While it often resolves on its own, POAF is also associated with longer hospitalizations, higher healthcare costs and an increased risk of poor clinical outcomes, including long-term mortality.
    • “How can care teams work to minimize a patient’s risk of developing POAF? What is the best way to manage POAF once it develops? To answer those very questions, the Society of Thoracic Surgeons (STS) gathered a committee of cardiac surgeons, cardiologists, anesthesiologists and intensivists who specialize in POAF. The group reviewed years of data, including randomized trials and contemporary treatment guidelines, and landed on a total of 15 recommendations for reducing the risk of POAF after cardiac surgery. This included eight preventive strategies, three intraoperative techniques and four postoperative treatments.
    • “The committee’s report, first presented at the STS annual meeting in New Orleans, is now published in full in The Annals of Thoracic Surgery.

From the U.S. healthcare business front

  • Health Exec kindly offers five reasons not to (solely) blame insurance companies for what ails US healthcare.
    • High health insurance premiums are largely driven by high underlying healthcare costs. 
    • Health insurers don’t raise premiums to be mean, greedy or otherwise uncaring. 
    • As a share of premium revenues, health insurers’ profit margins are generally modest.
    • Prior authorization: A necessary ‘evil’ without which things would be worse. 
    • There’s enough blame to go around. 
  • Health Exec reports,
    • “TV viewers of a certain age have a hard time avoiding commercials hawking pharmaceutical and medical products. That category is the second-most heavily advertised on TV. Only entertainment is ahead of it. 
    • “And that’s just TV. Across all media, pharmaceutical companies are spending close to $10 billion per year on direct-to-consumer advertising in the U.S., MediaRadar reports. Only the entertainment industry spends more. 
    • “This kind of drug-pushing is legal, of course. But is it good for the health status of Americans?
    • “There are two schools of thought on that question. One defends a soft yes, the other a hard no. Both get a hearing in a slice of investigative journalism from KFF Health News in partnership with The New York Times.”
  • MedCity News notes
    • “Regeneron Pharmaceuticals’ Otarmeni is now approved for treating hearing loss from an ultra-rare genetic mutation found in an estimated 50 newborns per year. While Regeneron will offer this gene therapy for free, the approval came with a rare pediatric disease priority review voucher that the company can sell for hundreds of millions of dollars.”

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.”

Tuesday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–
  • The Wall Street Journal reports,
    • “The Medicare agency will extend a short-term program that will pay for weight-loss drugs such as Eli Lilly’s Zepbound and Novo Nordisk’s NOVO.B -4.19%decrease; red down pointing triangle Wegovy, guaranteeing access to the popular medications will continue for seniors next year. 
    • “The decision by the Centers for Medicare and Medicaid Services comes after big Medicare insurers signaled that they didn’t initially plan to join a separate, longer-term payment model for the drugs that was supposed to launch at the start of 2027, throwing its future into question.
    • “Instead, the interim Medicare program, which starts in July and was expected to run only until the end of 2026, will continue until the end of 2027. Under this program, the government effectively pays for the medications, rather than adding them to Medicare insurers’ drug plans, which forces the insurers to account for the cost. 
    • “A CMS spokeswoman said the agency was extending the short-term program “after listening to stakeholder feedback.” The change will “allow data collection that will support a more effective potential implementation” of the longer-term model.
    • “The decision is good news for manufacturers such as Lilly and Novo Nordisk, which are counting on Medicare coverage to boost sales of their weight-loss drugs. Previously, Medicare Part D plans have been barred from covering weight-loss drugs, which means seniors who want to take them have had to pay several hundred dollars a month out of pocket.”
  • The House Appropriations Committee did not complete voting on the Financial Services and General Government (FSGG) bill today, having taken up and passed a Military Construction and Veterans Affair bill as the first order of business. The Committee will resume considering the FSGG bill tomorrow morning at 10 am ET.
  • The American Hospital Association News lets us know,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. April 21 testified in two hearings on the proposed fiscal year 2027 HHS budget, which requests $111.1 billion. In the morning, Kennedy testified before the Energy and Commerce Committee Health Subcommittee, and in the afternoon, he appeared before the Senate Appropriations Committee’s Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. He testified last week in a pair of meetings, one at the House Ways and Means Committee and another at the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.
    • ‘While the budget request is not binding, it serves as a preliminary framework for Congress and the administration as they determine federal funding levels and the scope of health care policy this year.”
  • STAT News relates
    • “The Trump administration will ask states to create new plans to verify medical providers paid by federally funded health care programs as part of a broad effort to combat fraud in government programs, Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, said Tuesday.
    • “The administration will ask states to develop plans in the next month to revalidate providers in “high-risk” areas to determine whether they exist and have the right to provide services, Oz said at Politico’s health care summit.
    • “The announcement is another step from the administration in its aggressive — and highly publicized — attacks on alleged waste, fraud, and abuse in federal health care programs. The administration has targeted certain programs and providers primarily in Democrat-led states such as Minnesota and California, though the administration’s claims have been disputed at times by state leaders. 
    • “We’re asking the states to own that problem,” Oz said.
    • “States that don’t take the effort seriously, he said, could become targets of closer federal scrutiny.”
  • The Government Accountability Office (GAO) adds,
    • “GAO has designated Medicare a high-risk program due, in part, to its complexity and potential for fraud. Fraud schemes in traditional Medicare often focus on certain services, such as durable medical equipment. Fraudsters may use stolen or inappropriately obtained Medicare beneficiary identifiers to submit fraudulent claims for unneeded or never provided services.
    • The Centers for Medicare & Medicaid Services (CMS), which oversees Medicare, uses data analytics on claims in traditional Medicare to identify anomalous patterns indicative of emerging fraud schemes and potentially fraudulent behaviors, such as billing spikes. CMS uses these analytics to develop leads for investigations and to inform administrative actions that can prevent potentially fraudulent payments, such as suspending provider payments. For example, in 2023 and 2024, CMS suspended payments to, and later revoked the enrollment of, 15 providers involved in a scheme that allegedly billed Medicare for more than $4 billion in urinary catheters that were never supplied. Selected private payers GAO spoke with reported using data analytics in ways similar to CMS—namely, to identify anomalous provider billing patterns to generate leads for investigations and to inform actions like payment suspensions.
    • CMS estimates that from fiscal years 2022 through 2024, it prevented a total of $11.9 billion in potentially fraudulent Medicare payments by taking administrative actions on providers engaged in potential fraud.
    • Here is a link to the GAO report.
  • The American Journal of Managed Care tells us
    • “Cancers with the highest lethality receive disproportionately lower levels of federal research support, according to a research letter published today in JAMA Network Open.
    • “Outcome-weighted metrics (mortality, 5-year survival, MIR) better capture unmet need than incidence alone when assessing cancer burden and urgency. 
    • “Lung cancers accounted for 151,401 deaths, exceeding pancreatic (49,211), breast (22,606), and prostate (5,219) among the cancers evaluated. 
    • “Mortality-to-incidence ratios highlighted extreme lethality in SCLC and pancreatic cancer (>0.85), while breast and prostate cancers showed low ratios (<0.10) consistent with higher survivorship. 
    • “Funding per estimated death was markedly higher for breast ($69,800) and prostate ($126,992) than pancreatic ($8,945) and SCLC ($2,818), supporting a composite allocation framework.”

From the Food and Drug Administration front,

  • Radiology Business informs us,
    • “Conavi Medical, a Toronto based medtech company, received U.S. Food and Drug Administration (FDA) clearance for a next-generation hybrid imaging system capable of performing intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at the same time. 
    • “Conavi has carved out its own space in the field of intravascular imaging by developing hybrid systems that save cath labs valuable space by performing two different exams of a patient’s coronary anatomy at once. The company’s original Novasight Hybrid System gained FDA clearance in 2018.” * * *
    • “Conavi hopes to start commercializing this next-generation technology and initiate a limited market release in the second half of 2026.”

From the judicial front,

  • STAT News reports,
    • “A judge is expected to sentence OxyContin maker Purdue Pharma to forfeit $225 million to the Justice Department on Tuesday, clearing the way for the company to finalize a settlement of thousands of lawsuits it faces over its role in the opioid crisis.
    • “The penalty was agreed to in a 2020 pact to resolve federal civil and criminal probes it was facing. If the judge signs off, other penalties will not be collected in return for Purdue settling the other lawsuits.
    • “After years of legal twists and turns, the settlement was approved by another judge last year and could take effect May 1. It requires members of the Sackler family who own the company to pay up to $7 billion to state, local and Native American tribal governments, some individual victims and others.”

From the public health and medical research front,

  • MedPage Today reports,
    • “A mobile health intervention helped pregnant patients with overweight or obesity reduce gestational weight gain (GWG), a cluster-randomized trial showed.
    • “The weekly rate of GWG was significantly lower in the intervention group versus the standard care group (mean 0.25 vs 0.28 kg/week; mean between-group difference -0.03, 95% CI -0.05 to -0.01), reported Monique M. Hedderson, PhD, of Kaiser Permanente Northern California in Pleasanton, and colleagues.
    • “Total GWG was also significantly lower in the intervention group, at a mean of 9.7 kg compared with 10.6 kg in the standard care group (mean between-group difference -0.87, 95% CI -1.40 to -0.34), they wrote in JAMA Network Open.” * * *
    • “The Lifestyle, Eating, and Activity in Pregnancy (LEAP) intervention utilizes a smartphone app, wireless scale, and activity tracker to promote healthy eating and increased activity. As a stepped intervention, more intensity is reserved for those on track to gain more weight. All participants are given a personalized calorie target and weekly education topics, and are encouraged to track weight, activity, and diet. Step two adds two weekly personalized chat messages with a lifestyle coach/registered dietitian and step three adds biweekly telephone sessions.
    • “LEAP shows “that combining clinician engagement with patient‑facing digital tools can improve gestational weight outcomes in real‑world care settings,” Hedderson said.”
  • Medscape points out,
    • “The American College of Physicians (ACP) has updated its guidance on screening for breast cancer in asymptomatic average-risk women using recent high-quality clinical recommendations from guideline developers from expert societies around the world.
    • “Publishing in the Annals of Internal Medicine, panelists led by Amir Qaseem, MD, PhD, MHA, the ACP’s chief scientific officer and senior vice president of clinical policy, made five recommendations, taking into account age group and breast density category.
    • “This updated guidance statement is based on new data and new or updated guidelines evaluated by the ACP since the publication of our 2019 guidance statement, which is over 7 years old,” Qaseem told Medscape Medical News.”
  • The American Medical Association lets us know what doctors wish their patient knew about appendicitis.
    • “There’s a pain in your abdomen. Is it something as simple as gas or is it appendicitis? Four physicians share what to keep in mind about appendicitis.”
  • Health Day informs us,
    • “The overdose-reversing drug naloxonehas been rightly hailed as a lifesaving breakthrough, saving countless lives from opioid ODs.
    • “But a new study warns that the wonder drug has its limits, especially when confronted with overdoses involving the powerful new wave of synthetic opioids like fentanyl.
    • “Naloxone may not fully reverse ODs caused by synthetic opioids, researchers report in the May issue of the journal Anesthesiology.
    • “As a result, bystanders should be ready to give additional doses of naloxone if the first doesn’t restore an overdose victim’s breathing, researchers said.”
  • Genetic Engineering and Biotechnology News relates,
    • “Researchers from Kindai University in Japan have developed a machine learning model that accurately predicts the origin of diverse cancer types in patients with cancers of unknown primary (CUP) by analyzing CpG-based DNA methylation. Results showed that the model correctly identified the cancer type in about 95% of cases in the test cohort and achieved 87% accuracy when applied to an independent validation cohort from 31 cases representing 17 different cancer types. The work was presented at the American Association for Cancer Research (AACR) Annual Meeting.  
    • “Our findings suggest that DNA-based approaches can help identify where a cancer may have started, even when the original tumor is not visible,” said Marco A. De Velasco, PhD, a faculty member in the department of genome biology at Kindai University in Japan.”  
  • STAT News notes,
    • “BioAge Labs said Tuesday that its investigational pill for cardiovascular risk prevention significantly reduced inflammation in an early study, as more drug companies target inflammation as a way to treat a range of chronic conditions.
    • “In a Phase 1 study of people with obesity and elevated inflammation levels, patients taking a 60-milligram dose of the drug, called BGE-102, experienced an 85% reduction in a measure of inflammation called high-sensitivity C-reactive protein (hs-CRP) after one week, and the reduction was maintained three weeks out. That’s a similar effect seen in patients who took a higher 120-mg dose in the study, which the company previously reported.”
    • “Additionally, 87% of patients taking the 60-mg dose achieved hs-CRP levels of less than 2 mg/liter, the threshold thought to be associated with a lower risk of cardiovascular complications.
    • “High cholesterol and blood pressure have long been known contributors to heart disease, but researchers more recently identified inflammation as a risk factor as well. Companies like BioAge are betting that drugs that can effectively reduce inflammation could one day be as widely used as statins.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • :UnitedHealth Group UNH reported first-quarter results that substantially overshot Wall Street expectations and raised its annual guidance, signaling progress in its financial turnaround.
    • The announcement is likely to build investor confidence in the healthcare company’s current direction, a year after UnitedHealth announced an earnings shortfall that touched off an unprecedented share meltdown for the company.
    • “Former Chief Executive Stephen Hemsley returned to the top job last May, saying the company needed a reset. He has focused on retrenching and bolstering margins.” * * * 
    • “UnitedHealth highlighted changes made under Hemsley’s tenure, including replacing almost half the company’s top 100 executives and making substantial artificial-intelligence investments. UnitedHealth said it had struck a deal to take over Alegeus Technologies, a benefits-administration company, without disclosing the financial terms.”  
  • BioPharma Dive relates,
    • “Flagship Pioneering has launched a new biotechnology firm that believes it’s found a way to solve the problems that have long held back genetic medicine. 
    • “Called Serif Biomedicines, the startup officially debuted on Tuesday armed with $50 million in funding and the ability to make what it refers to as “modified DNA” medicines.
    • “According to CEO and co-founder Jacob Rubens, Serif’s drugs are designed to combine the strengths of multiple types of genetic medicines, from gene therapy to the messenger RNA and small-interfering RNA approaches popularized by companies like Moderna and Alnylam Pharmaceuticals. Its treatments consist of two components: finely tuned instructions for a therapeutic protein as well as an mRNA sequence for “co-factors” that can help the treatment get into a cell’s nucleus. They’re sent to cells with the help of fatty shells called lipid nanoparticles, which are commonly used to deliver complex medicines.”
  • Adam Fein writes in his Drug Channels blog,
    • “Drug Channels Institute’s (DCI’s) latest analysis reveals that PBM-affiliated specialty pharmacies continue to dominate the dispensing of specialty drugs. 
    • “For 2025, DCI has identified more than 1,900 dispensing locations with specialty pharmacy accreditation from one or both of the two major independent accreditation organizations. The overall number of accredited locations grew by only 3% in 2025, but is more than five times larger than the 2015 figure.
    • “However, market share for the dispensing of specialty drugs remains highly concentrated. For 2025, the three largest specialty pharmacies accounted for two-thirds of total prescription revenues from pharmacy-dispensed specialty drugs. These businesses are all owned by vertically integrated organizations that also own a PBM.”
  • Beckers Hospital Review informs us,
    • “More Wegovy prescriptions are being written as GLP-1 weight loss drugs gain traction across retail, telehealth and direct-to-consumer channels, according to an April 20 report from Truveta Research.
    • “The growth follows the FDA’s December approval of oral Wegovy (semaglutide) and other GLP-1 pills. Diverging commercialization strategies from manufacturers are also reshaping how patients access these therapies and how health systems approach formularies and metabolic care programs.”

Monday report

David Ermer–CMS, Congress, COVID-19 vaccine, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Tomorrow at 11 am ET, the House Appropriations Committee will consider its subcommittee’s print of the appropriations bill for financial services and general government, including the Office of Personnel Management for the fiscal year ending September 30, 2027.
  • The subcommittee’s print includes the standard appropriations provisions exempting FEHB and PSHB carriers from full Cost Accounting Standards coverage (Sec. 611) and limiting abortion coverage to cases when carrying the fetus to term would endanger the mother’s life or the pregnancy results from rape or incest (the Hyde amendment, Secs. 613, 614). The bill (Sec. 761) also states “None of the funds made available by this Act, or in any previous appropriation, may be provided for in insurance plans in the Federal Employees Health Benefits program to cover the cost of surgical procedures or puberty blockers or hormone therapy for the purpose of gender affirming care.” The bill no longer includes the contraception mandate that OPM treated as overridden by the ACA’s contraception mandate. 
  • Federal News Network reports,
    • “The Office of Personnel Management and the General Services Administration — the federal government’s human resources office and landlord, respectively — are embarking on plans to move under one roof.
    • “GSA will temporarily relocate to OPM’s headquarters, the Theodore Roosevelt Federal Building, starting in July, while GSA’s 1800 F St. headquarters goes through a renovation.
    • “In December 2028, GSA will move back into its renovated headquarters, along with OPM. Once consolidation is complete, GSA says it will initiate an “accelerated disposal” of OPM’s old headquarters building.” * * *
      “The first Trump administration proposed merging OPM and GSA into a single agency, but ultimately walked away from those plans. In addition to managing a governmentwide real estate portfolio, GSA provides contracting and IT support to other federal agencies.
    • “OPM Director Scott Kupor said there are no talks of a possible merger of the two agencies.”
  • and
    • “House and Senate Democrats are urging the Office of Personnel Management to halt its plans for collecting detailed medical data on potentially millions of enrollees in the government’s health insurance programs.
    • “Citing “significant legal, ethical and security concerns,” two recent letters sent to Trump administration officials identified potential legal violations and the possibility of targeting enrollees across the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs.
    • “The collection of broad, personally identifiable data regarding medical care and treatment raises concerns that OPM could target certain federal employees seeking vital health care services that the administration disagrees with on political grounds,” House Democrats on the Oversight and Government Reform Committee wrote in an April 17 letter, addressed to OPM and the Office of Management and Budget.
    • “This proposal is another step in the stated goal of traumatizing the federal workforce,” Senate Democrats, led by Sens. Adam Schiff (D-Calif.) and Mark Warner (D-Va.), wrote in a separate April 19 letter to OPM Director Scott Kupor. “We are deeply concerned this information will be used in employment actions, including actions related to hiring, suitability determinations, appeals, reductions in force, disability accommodation requests, labor-management relations and performance reviews.”
  • Roll Call adds,
    • “Senate Republicans plan to release their budget resolution and take a procedural vote as early as Tuesday, kicking off the cumbersome process for a reconciliation bill designed to help end the partial shutdown of the Department of Homeland Security.
    • “Senate Majority Leader John Thune, R.S.D., said Monday he hopes to confine the bill to the narrow mission of funding Immigration and Customs Enforcement and the Border Patrol. “
  • HR DIve relates,
    • “Secretary of Labor Lori Chavez-DeRemer resigned on Monday, she confirmed in a post to her official X account, ending her tenure after just over one full year leading the U.S. Department of Labor.
    • “Chavez-DeRemer’s departure followed recent reports that the agency’s inspector general had launched an investigation into her potential misconduct, including contact between her family and department staff. Similar previous inquiries reportedly led to the departure of employees including Chavez-DeRemer’s chief of staff and deputy chief of staff.
    • “Chavez-DeRemer said in her post Monday that under her watch, DOL “created new pathways to mortgage-paying jobs, prepared workers to excel in the age of AI, took steps to lower prescription drug costs, promoted retirement security, and so much more.” A White House spokesperson did not immediately respond to a request for comment.”
  • The American Hospital Association News tells us
    • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., and CMS Deputy Administrator and Director of Medicaid and CHIP Dan Brillman sat down with Bill Gassen, president and CEO of Sanford Health and AHA chair-elect, for a discussion about the changes that have occurred in CMS in the past year, as well as how they intend to move forward.  
    • Oz described the agency’s focus this year on working with insurers to reduce the need for prior authorizations. In addition, both Oz and Brillman spoke on the agency’s drive to reduce unnecessary spending; Oz estimated that 5% of CMS’ budget, or about $100 billion, is lost to fraud, waste and abuse.  
    • “Brillman spoke on the new community engagement standards that require most Medicaid recipients to perform a certain number of employment or volunteer hours to maintain their eligibility for benefits, which Brillman said provides “paths to prosperity” for beneficiaries, saying, “if we get someone a higher income so they no longer need services, that’s a win for all Americans.” 
    • “Technology, especially the use of artificial intelligence, was also acknowledged as an important advancement, with Oz saying that current technology offers “a generational opportunity to fix health care,” noting that “I do not see a way to make health care as great as it could be without AI.”  
    • “Oz spoke on last year’s Rural Health Transformation Fund, saying that the infusion of $50 billion over five years will have nationwide effects. “The learnings will accrue to urban centers,” he said. “[The fund] is creating a sandbox in rural areas, and what you learn will benefit all of you.” 

From the public health and medical / Rx research front,

  • Health Day reports,
    • “Reaching for the salt shaker could have long-lasting implications for your memory and brain health, a new study says.
    • “Higher sodium intake appears to affect episodic memory, the type of memory used to recall personal experiences and specific events from your past, researchers report in the June issue of the journal Neurobiology of Aging.
    • “This effect – which could cause one to forget anything from where they parked the car to their first day of school – occurred mainly among men, researchers found.
    • “No such associations were observed among women in the study, researchers said.”
  • The American Medical Association lets us know seven things patients should know about protein maxxing.
  • Healio relates,
    • “Prescriptions for direct-acting antivirals to treat hepatitis C virus in the U.S. have declined substantially since 2015 and remain well below the approximately 260,000 annual treatment courses needed to meet the target for elimination.
    • “Results of a national cross-sectional analysis showed annual treatment volume trending alongside HCV infection rate, rather than surpassing it.
    • “We’re roughly treating the same number of people each year as there are new infections,” Sanjay Kishore, MD, assistant professor at University of Virginia School of Medicine, told Healio. “We’re essentially just holding steady and not actually making any progress.” * * *
    • “I think we need to think creatively about using things like mobile clinics to take care of people. We need to really lean into telehealth on this issue, and we need to expand screening to places where people are getting addiction treatment. Maybe instead of a hospital, it’s a rehab facility or a syringe exchange. We need to make it easier to connect with clinicians and get treatment to meet people where they are.”
  • MedPage Today tells us,
    • “Adults whose type 2 diabetes was treated with GLP-1 receptor agonists were more than likely to develop cognitive impairment over 10 years than their counterparts not treated with GLP-1 agents, a propensity-matched retrospective study of nearly 65,000 patients suggested.”
  • and
    • “Lower hemoglobin levels were linked with higher dementia risk over 9 years of follow-up.
    • “Anemia was associated with elevated Alzheimer’s blood biomarkers including p-tau217 and neurofilament light chain.
    • “Dementia risk was highest when anemia coexisted with abnormal Alzheimer’s biomarkers.”
  • BioPharma Dive offers news from the annual meeting of the American Association for Cancer Research and informs us,
    • “An experimental autoimmune drug from Nektar Therapeutics helped people with alopecia areata who’d already responded to the treatment in a Phase 2 trial grow more hair as time went on, the company said Monday.
    • “The data released Monday measured hair regrowth after 52 weeks of treatment with the therapy, known as rezpegaldesleukin. Nektar disclosed last year that the therapy failed to show a statistically significant benefit over a placebo after 36 weeks. The company, though, blamed that result on the inclusion of four patients that shouldn’t have been eligible and said the findings supported additional development.”
  • Fierce Pharma points out,
    • “Sanofi’s protein-based vaccine Nuvaxovid has conquered Moderna’s next-generation messenger RNA shot mNexspike in a head-to-head trial assessing the tolerability of the two COVID vaccines.
    • “In the phase 4 double-blind, real-world study, which included 1,000 adult participants in the United States, Nuvaxovid showed statistically significant fewer side effects across all pre-specified endpoints.
    • “Symptomatic reactions with Nuvaxovid were both milder and shorter than with mNexspike. Additionally, less than 10% of those who received Nuvaxovid experienced severe side effects—such as fatigue, headache or fever which prevented them from conducting their daily activities—compared to 20% of those who got mNexspike. As for injection site symptoms such as pain, redness and swelling, they were more than 75% more frequent for those who received Moderna’s shot.”

From the U.S. healthcare business front,

  • ‘Per a Lockton news release,
    • “Lockton’s eighth annual survey of over 1,700 U.S. employers helps employers compare their benefit strategies with those of other employers -providing benchmark data, highlighting trends, and illuminating new ideas.
    • “As healthcare costs rise and economic pressures mount, cost is a defining reality for employers. The 2026 Lockton National Benefits Survey shows a rapid acceleration of a shift that first took hold last year – cost management decidedly the top priority vs the next ranked priority – attracting and retaining talent. The data shows how employers are searching for an answer to their need for cost containment solutions.
    • “To gain further insights into the 2026 survey findings, you can access the executive summary here.”
  • The Peterson / KFF Health System Trackers identifies recent trends in employer-based health coverage.
    • “Key takeaways include:
      • “In March 2025, 60.0% of the non-elderly, or about 165.6 million people, had employer sponsored insurance or ESI. 
      • “About four in five (80.4%) adult non-elderly workers worked for an employer that offered ESI to at least some employees, a share that has been consistent over recent years. 
      • “The share of workers eligible for ESI at their job declined slightly over the past few years, from 75.3% in March 2023 to 74.6% in March 2025. 
      • “Most eligible workers who do not take up ESI offered at work cite other coverage (63.0%) and cost (30.2%) as the reason.”  
  • Beckers Hospital Review tells us,
    • “As more care shifts outside hospital walls, health system leaders are rethinking how they plan, staff and structure their workforces to support a rapidly expanding ambulatory footprint.
    • “Outpatient services accounted for 57% of hospital revenues in 2024, up from 52% in 2020, according to the American Hospital Association. The AHA’s Sg2 forecasting model projects outpatient volumes will grow another 17% over the next decade. At the same time, many health systems are accelerating ambulatory investments in 2026 to support financial sustainability and expand access closer to home.”
  • MedCity News notes that “Expanding the CJR Model Is a Logical Step in Value Based Care, but Implementation Challenges Remain.”
    • “CMS is proposing to make its joint replacement bundled payment model mandatory nationwide. Experts say it is a logical step, but warn that mandatory participation could be challenging for hospitals to implement.”
  • Healthcare Dive relates,
    • “Physician burnout continues to decline across the U.S., a bright spot for an occupation plagued by heavy workloads, pervasive stress and high stakes. But the improvement is not equal across medical specialties, according to new data from the American Medical Association.
    • “The AMA surveyed thousands of physicians and found that 41.9% reported experiencing a burnout symptom in 2025, down from 43.2% in 2024 and 48.2% in 2023. The decline likely reflects employer efforts to reduce burnout, including by increasing job satisfaction, the medical association said.
    • “However, burnout rates vary significantly across specialties, and tend to be higher among doctors employed by hospitals, suggesting health systems could be doing more to ameliorate the phenomenon.”
  • Fierce Healthcare informs us,
    • “UnitedHealthcare is building on its work to support rural hospitals and will now exempt these facilities from most prior authorizations.
    • “The insurance giant said in an announcement on Monday that the shift will apply across all lines of business. In addition, UHC will accelerate payments by up to 50% for about 1,500 rural hospitals and all critical access hospitals across the country.”
  • and
    • “Just over two years ago, Highmark joined forces with Spring Health to launch a new mental well-being platform that made it far easier for members to access critical services.
    • “Now, the partners are offering a look at how that program has worked for members. In a paper published last month, researchers at Highmark reported that patients waited less than two days on average in 2025 to access an appointment.
    • “Spring’s platform is embedded directly into Highmark’s member app, and that integration was a key part of what made the program work, according to the analysis. Members can easily find mental well-being tools and complete a self-assessment upon connecting for the first time, which allows Spring to build a personalized approach.”
  • The Wall Street Journal points out,
    • “Eli Lilly struck a deal to acquire Kelonia Therapeutics for $3.25 billion upfront and up to $7 billion if certain milestones are reached. 
    • “Kelonia is developing a next-generation CAR-T therapy for multiple myeloma, which promises to transform treatment without chemotherapy.
    • “The acquisition positions Eli Lilly to enter a lucrative segment of the global cancer-drug market and bolster its cancer offerings.”
  • MedTech Dive adds,
    • “Medtronic said Monday it has closed the acquisition of CathWorks, a deal worth $585 million with potential undisclosed earn-out payments.
    • “The transaction, agreed to in February, continues a strategy of increasing acquisitions to strengthen the company’s leadership in its core businesses, Medtronic said.
    • “CathWorks’ FFRangio system uses artificial intelligence and computational science to assess the entire coronary tree from routine angiograms that image the blood vessels.”

Weekend update

David Ermer–Congress, Medical / Rx research, Mental health care, Rx coverage–

From Washington, DC,

  • Roll Call previews this weeks activities on Capitol Hill.
    • “The House Appropriations Committee begins its markup of both the Military Construction-VA and Financial Services spending bills on Tuesday, with subcommittee consideration of the National-Security State and Agriculture bills scheduled for Thursday.
    • “Senate appropriators have a full slate of hearings on Tuesday and Wednesday, with Health and Human Services Secretary Robert F. Kennedy Jr. slated to appear before the Labor-HHS-Education Appropriations Subcommittee on Tuesday.
    • “A bunch of other Cabinet members will follow at their respective subcommittees on Wednesday, including Treasury Secretary Scott Bessent.”
  • The New York Times reports,
    • “President Trump on Saturday signed an executive order seeking to hasten research into the therapeutic benefits of LSD, Ecstasy, psilocybin and other mind-altering drugs by ordering federal agencies to ease restrictions that have long limited the ability of scientists to study them.
    • “The measure also provides $50 million for state-level research into ibogaine, a powerful psychedelic made from the root of a Central African shrub that has been drawing interest from researchers for its potential to treat opioid use disorder and other forms of substance abuse.
    • “The funding will most immediately benefit Texas, which has already committed $50 million to studying ibogaine but recently failed to secure matching funds from a private drug developer.
    • “I’m pleased to announce historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs,” Mr. Trump said from the Oval Office, where he was joined by a number of top cabinet officials and the podcaster Joe Rogan.”
  • Here is a link to the White House fact sheet on this executive order.

From the census front,

  • The New York Times informs us,
    • “Fertility in the United States has been declining since the Great Recession, and reached a new low last year, according to federal data released Thursday {april 9], causing some to fear a baby bust.
    • “But it’s not clear that will happen. Instead, there could be a lull, demographers say — a period of very low fertility that could eventually rebound.
    • “That’s because of a drastic shift among American women who are now of childbearing age: They are waiting longer to have babies. They’ve become much less likely to have them in their teens or 20s — and much more likely to in their 30s or 40s.
    • “Demographers have a name for this kind of lull in fertility: a “postponement transition.” It happened in the 1990s in Europe, then rebounded somewhat as the younger women who delayed pregnancy eventually had children. It also happened in the United States in the 1970s, as more women pursued college and careers after the women’s movement. These women didn’t end up having fewer children; they just had them later.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Doctors may be getting closer to having a potent weapon against a genetic driver of lung cancer that has long lacked any targeted treatment options.
    • “Researchers on Sunday presented early results of clinical trials of two experimental drugs targeting a gene called KRAS, one of the most common and challenging drivers of human cancers. Each drug takes aim at a different KRAS mutation that drives lung cancer, which kills more people worldwide each year than any other form of the disease.
    • “KRAS mutations act as an accelerator in cancer cells. Both drugs shrank tumors and slowed disease progression in patients with advanced cancer that had progressed despite standard chemotherapy and immunotherapy, raising hopes that doctors may be homing in on a new option for a form of cancer that has long resisted treatment. 
    • “I’ve never been this hopeful about KRAS mutations,” said Dr. Lei Deng, an oncologist at Fred Hutch Cancer Center in Seattle who wasn’t involved in either study. The research was presented at the American Association for Cancer Research annual meeting.”
  • Healio points out,
    • “Odds for developing Parkinson’s disease increased with newer groundwater and with carbonate aquifers, according to a poster presented at the American Academy of Neurology Annual Meeting. 
    • “Our previous studies have focused a lot on air pollution, but we know from prior research that contaminated drinking water can also impact health,” Brittany Krzyzanowski, PhD, who conducted the study at Barrow Neurological Institute, told Healio.
    • “There’s a wealth of underused data on drinking water sources, like aquifer type and groundwater characteristics, so we took the opportunity to explore how these factors might be linked to Parkinson’s disease,” said Kryzyzanowski, who is now with the Atria Research Institute.”

Froom the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY is in advanced talks to acquire Kelonia Therapeutics for more than $2 billion, according to people familiar with the matter.
    • “A deal could come as soon as Monday, assuming the talks don’t fall apart, the people said. The deal price could also include additional consideration if Kelonia reaches certain milestones, they said.
    • “Privately held Kelonia is developing a next-generation treatment for the blood cancer multiple myeloma. Buying it would position Eli Lilly to boost its position in the lucrative blood-cancer segment of the $240 billion global cancer-drug market.
    • Kelonia has raised just under $60 million to date, with its last public valuation being a little over $100 million as of April 2022, according to data from PitchBook.
    • “Kelonia is developing a next-generation so-called CAR-T therapy. CAR-T therapies deliver genes—or genetically altered cells—to help a patient’s immune system fight the cancer. 
    • “We have something that is truly transformative to the space,” Kelonia Chief Executive Kevin Friedman said in an interview in January at an industry conference.”
  • Fierce Healthcare tells us,
    • “More than 80% of primary care physicians are concerned about financial stability over the next several years, new research from Elation Health found.
    • “The health tech company surveyed 280 PCPs from Jan. 31 to Feb. 23 for its 2026 Primary Care Pulse Survey Report. Fifty-two percent of respondents were fully independent and 48% have some affiliation. 
    • “As financial pressures mount for PCP practices, 64% cite government and commercial payer reimbursement as their top concern. Staffing costs, workforce challenges, technology and IT costs and rising operational costs are also challenges for responding physicians. 
    • “Simultaneously, the report found 68% of respondents are actively developing plans to address concerns—ranging from increasing marketing to adopting new payment models. Sixty-seven percent of respondents plan to implement changes within the next two years while 27% report already implementing membership or cash-pay models and 18% report adopting value-based payment structures.” 

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. sought to distance himself from U.S. measles outbreaks on Friday at a House Education and Workforce Committee hearing on the administration’s fiscal 2027 budget request.
    • “The hearing, part of Kennedy’s weeklong tour of Congress on the budget, was relatively light on spending discussions, as Democrats who have repeatedly requested such a hearing with Kennedy looked to pin him down on a range of issues. The hearing was often combative, with Democrats drawing attention to issues such as vaccines and Kennedy’s focus on school nutrition.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services today announced the appointment of Casey B. Mulligan, PhD, as Chief Economist and Chief Regulatory Officer. Mulligan is a renowned University of Chicago economist who served as Chief Economist on the Council of Economic Advisers during the first Trump Administration. He most recently served as the U.S. Small Business Administration’s Chief Counsel for Advocacy.
    • “Mulligan will advise Health and Human Services Secretary Kennedy Robert F. Kennedy, Jr., and other agency leaders on policy development to continue to make health care more affordable for the American people. His portfolio will include cost-benefit analysis of regulation, econometric modeling, and program evaluation of major expenditures.”
  • Fierce Healthcare relates,
    • “Insurers hoping for a reprieve from an out-of-network billing system largely favoring healthcare providers will likely be left wanting as federal policymakers sit on their hands and one large payer’s bid to limit the claims faces an uphill battle, strategy firm Capstone concluded in a new report.” * * *
    • “Capstone expects any meaningful reversal of the IDR trend to most likely stem from direct action by payers. Chief among these is an administrative penalty Elevance Health implemented in 11 states for its Anthem BCBS commercial business. The policy levies a fee equal to 10% of the allowed amount on facility claims involving OON providers.
    • “The policy has faced substantial pushback from provider groups, though it still went into effect Jan. 1 in the 11 states with plans to expand similar fees in two more. Capstone noted that one of the initial states, Indiana, has already enacted legislation against the practice and that the broader policy is primed for legal challenges.
    • “However, if Elevance’s model is adopted more broadly, the OON ecosystem could shrink as facilities internalize the direct financial cost of hosting OON providers,” Capstone wrote. “In that scenario, provider groups would face pressure to either absorb the loss of facility relationships or accept often-lower in-network rates.” 
  • Bloomberg Law points out,
    • “The head of the Department of Labor’s employee benefits regulator defended how he’s changed the agency before lawmakers, saying he’s cut down on excessive litigation and enforcement.
    • “Daniel Aronowitz, leader of the Employee Benefit Security Administration, told members of a House Education and the Workforce subcommittee that the agency had reoriented its approach to follow the Employee Retirement Income Security Act, boasting that it was “the most pro-ERISA EBSA administration ever.” * * *
    • “The agency is revisiting a Biden-era [mental health] parity rule creating a comparative test to ensure employers are covering mental health equally with medical and surgical benefits. EBSA halted enforcement of the rule after The ERISA Industry Committee sued.
    • “Aronowitz noted that he didn’t believe the rule’s comparative analyses “got us anywhere. It just created cost and burden.”
    • “But he said EBSA is conducting investigations on medical necessity denials, exclusions for autism and opioid treatment, so-called “ghost networks” of unavailable doctors, and conflicts of interest.”
  • Thompson Reuters discusses this year’s obligation to provide notices of creditable coverage to Medicare Part D eligible individuals and to CMS.
    • “Sponsors of HRAs and other account-based plans, which are typically offered alongside major medical plans, will welcome the relief from providing burdensome and potentially confusing Part D creditable coverage notices. Sponsors of plans that remain subject to the disclosure requirements should use the 2027 parameters when determining whether their plans’ prescription drug coverage is creditable for that year.”
  • Healthcare Dive tells us,
    • “Employers, lawmakers, patient advocates, price transparency groups and more urged the Department of Labor to quickly finalize a rule that would force pharmacy benefit managers, shadowy middlemen in the drug supply chain, to share more pricing and compensation information.
    • “PBMs did not feel the same, according to industry comments on the proposed regulation.
    • “The rule has been caught up between two powerful industries — healthcare purchasers like employers and the PBMs they contract with to manage their drug benefits — since it was proposed in January, amid growing criticism of PBMs and a broader bet from the Trump administration that better price transparency will lower healthcare costs.”
  • and
    • “The CMS has proposed repealing the alternative pathway for new technology add-on payments, or NTAP, beginning in fiscal year 2028. The change is included as part of the 2027 Inpatient Prospective Payment Systems proposed rule. 
    • “Under the proposal, medical devices with breakthrough device designation would be required to meet the same eligibility criteria as other available technologies to receive the additional payments under the NTAP pathway.
    • “Industry trade group AdvaMed said the alternative pathway policy, implemented by the first Trump administration, has worked well. AdvaMed, in an emailed statement to MedTech Dive, said “it would be disappointing if this progress were rolled back.”

From the Food and Drug Administration front,

  • Healio reports,
    • “The FDA has cleared an HPV self-collection kit and approved a related HPV assay for at-home use, enabling patients to obtain their own sample for cervical cancer screening.
    • “The Onclarity HPV Self-Collection Kit (Waters Corp.) is tested with the BD Onclarity HPV Assay (Waters Corp.), which now supports specimens collected both in clinic and at home. The assay detects all high-risk, carcinogenic genotypes and is the only FDA-approved HPV assay to identify “six individually and three groups of pooled results,” according to a manufacturer press release.
    • “The at-home, self-collection kit could help reduce barriers for unscreened or underscreened individuals, who comprise nearly 60% of cervical cancer cases.”
  • MedTech Dive relates
    • “Philips has received Food and Drug Administration clearance for an artificial intelligence-enabled CT system.
    • “The 510(k) clearance, which Philips disclosed Thursday, covers a Verida device that the company claims reduces image noise by 80% and reconstructs scans twice as fast as its predecessor.
    • “Jie Xue, chief business leader for precision diagnosis at Philips, recently said Verida’s throughput sets it apart from photon-counting CT technology. GE HealthCare and Siemens Healthineers sell photon-counting devices.”
  • CVS Health informs us,
    • “New treatments take years of research, clinical trials, and regulatory review before reaching patients. Several therapies approaching FDA decisions this spring could expand treatment options for people managing a range of conditions.
    • “CVS Caremark’s Clinical Pipeline Services team — made up of licensed clinical pharmacists and analysts — monitors new therapies moving through the drug pipeline and evaluates what those approvals could mean for members. The team’s latest Drugs to Watch report identifies several notable therapies with decisions expected between April and June 2026, including:
      • “A new oral option for patients with treatment-resistant hypertension
      • ​​​”A more convenient, at-home format for early Alzheimer’s disease treatment that avoids lengthy IV infusions​​​​​​​​​​
      • “The first FDA-approved treatment for a chronic ​​​​liver infection
      • “An additional non-nicotine option for adults looking to quit smoking.”

From the judicial front,

  • Bloomberg Law reports,
    • “A wave of hospital bankruptcies has brought in its wake high-stakes lawsuits aiming to boost creditor payouts by targeting health insurers over allegedly systemic claim denials.
    • “At least nine different health insurers in the past six months have been sued by bankruptcy estates or trustees appointed under bankruptcy plans for three major health-care businesses, according to court documents reviewed by Bloomberg Law. 
    • “Lawsuits against insurers for Steward Health Care System LLC, CarePoint Health Systems Inc., and Jackson Hospital & Clinic Inc. seek a combined $427.9 million and represent 32,000 patient claims across 32 hospitals and providers and six states.
    • “The litigation is ramping up as hospital bankruptcies accelerate amid disputes over private equity ownership, real estate investment trust structures, and federal cuts.” * * *
    • “A trustee for CarePoint, which operated three New Jersey safety-net hospitals before it filed for Chapter 11 in November 2024, sued Cigna Health & Life Insurance Co. in February. It argued Cigna underpaid its hospitals for various services by more than $114 million.
    • “Steward’s trustee filed at least seven lawsuits against insurers, including Blue Cross of Florida, CareSource Ohio, and Aetna Health, seeking to recover more than $63 million and alleging they withheld valid reimbursements.
    • “Jackson Hospital took a different approach, bringing a more than $250 million antitrust suit against Blue Cross and Blue Shield of Alabama in December. The insurer used market domination to allow for a pattern of baseless claim denials for emergency care, the suit said.”

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 HHS 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. 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,
    • “There are now 602 cases in the Utah measles outbreak, the state’s Department of Health and Human Services reported April 14. Of those, 405 cases have been diagnosed this year. The confirmed total of measles cases reported nationwide in 2026 has increased to 1,748, according to the latest data from the Centers for Disease Control and Prevention. There have been 19 reported outbreaks across 33 jurisdictions. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape adds,
    • Use of preexposure prophylaxis (PrEP) for HIV prevention in adolescents and young adults is “strikingly low,” though youth aged 13-24 years have nearly 1 in 5 new HIV infections in the US, according to a new study in JAMA Pediatrics. Use is particularly low in women and young people who live in the South and Midwest.
    • “Efforts to expand PrEP use among youths should address geographic disparities, legal and policy barriers, and clinician engagement to improve equitable access to HIV prevention,” the authors wrote, led by Nicholas Venturelli, MD, MPH, with Boston Children’s Hospital in Boston.
  • The University of Minnesota’s CIDAP relates,
    • “Historically, shigellosis cases in the United States have primarily been seen in young children in daycare settings and in people who’ve traveled to countries with poor sanitation. Infections with Shigella, a gut pathogen that causes diarrhea and vomiting, have also been fairly easy to treat.
    • “But the profile of who’s most at risk of shigellosis is changing, and the infections is becoming much harder to treat, according to a report published last week in Morbidity and Mortality Weekly Report, the flagship publication of the Centers for Disease Control and Prevention (CDC).
    • “In the report, researchers from the CDC and health departments across the country revealed that the vast majority of US Shigella infections from 2011 through 2023 were in adult men, a high proportion of whom (47%) had HIV. Analysis of nearly 17,000 Shigella isolates found that the proportion of isolates considered extensively drug-resistant (XDR) rose from 0% during 2011-2015 to 8.5% in 2023. 
    • “Approximately one-third of patients were hospitalized. And among patients with travel history, more than 80% reported no recent international travel.
    • “The report’s corresponding author said the findings reflect changes in epidemiology and resistance that are transforming Shigella from a primarily self-limiting infection that rarely required antibiotics into an emerging public health threat with limited treatment options. 
    • “Together, it’s a very concerning pattern of XDR Shigella strains that are being seen among vulnerable populations,” Naeemah Logan, MD, an epidemiologist with the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, told CIDRAP News.”
  • The AP informs us,
    • “The worrisome rise in colorectal cancer deaths in younger adults is concentrated in people with less education, suggesting socioeconomic factors could be driving the escalation, according to a new study.
    • “Celebrity deaths — including Chadwick Boseman in 2020 and James Van Der Beekearlier this year — have highlighted the increase in colorectal cancer deaths among younger adults, but the new paper was called the first to parse which people are most affected by the alarming rise. 
    • “The researchers found that over the last 30 years, the rise in colorectal cancer deaths in young adults occurred almost entirely among people without a four-year college degree.
    • “Of course, getting a college degree doesn’t protect you from getting colon cancer. Rather, experts say it’s a marker for other issues: People without degrees tend to earn less money, have poorer diets, exercise less and get less medical care.
    • “It’s not totally unexpected that the death risk is concentrated in the less advantaged, but the paper published Thursday in JAMA Oncology is the first national study to actually show the connection, said Dr. Paolo Boffetta, a researcher at Stony Brook Cancer Center in New York who wasn’t involved in the work.” 
  • The New York Times points out,
    • “Researchers at the University of Pittsburgh reported on Friday that they had trained the immune systems of a few patients to accept liver transplants without the drugs needed to avoid organ rejection.
    • “Three of eight patients have now been off the drugs for at least three years, perhaps an early step toward a new approach to transplantation that experts in the field have long hoped for. The study was published in Nature Communications.
    • “They’ve gone a long way toward proving a principle,” said Dr. William Jarnagan, chief of liver and transplant surgery at Memorial Sloan Kettering Cancer Center, who was not involved in the study.
    • “With further development, it could really be a game changer,” he added.
    • “Dr. Joohyun Kim, a liver transplant surgeon at Yale who was not involved with the study, said, “Even 10 years ago, people thought ‘tolerance induction’ was a dream.”
  • The Genetic Engineering and Biotechnology News adds,
    • “The American Association for Cancer Research (AACR) Annual Meeting kicks off this weekend in San Diego. A whirlwind of sessions, keynotes, fireside chats, posters, and exhibitors, the meeting is THE annual event for the cancer community.
    • “Before the conference, GEN spoke with AACR program chairs Paul S. Mischel, MD, Professor and Vice Chair for Research for the Department of Pathology at Stanford Medicine of Stanford University and Alice T. Shaw, MD, PhD, Chair of the Department of Medical Oncology and the Chief of Strategic Partnerships at Dana-Farber. In this interview, they share their perspectives on the event, what attendees should be looking out for, and what they, personally, are most looking forward to.”
  • and
    • “For pathogens like HIV, malaria, and rapidly evolving influenza strains, coaxing the immune system to produce the rare, highly potent antibodies needed for protection has long been a scientific bottleneck. Vaccines can train B cells to evolve such broadly neutralizing antibodies, but only under ideal conditions—and only in a small fraction of people. Even attempts to genetically edit mature B cells produced responses that faded as the cells died out.
    • “A team at The Rockefeller University has now taken a more upstream approach: programming hematopoietic stem and progenitor cells (HSPCs)—the source of all B lymphocytes—to carry permanent genetic instructions for therapeutic antibodies or other proteins. Because the immune system naturally amplifies rare, useful cells after vaccination, even a tiny number of edited stem cells can seed a durable, boostable immune response.
    • “The immune system is inefficient in that it produces a vast quantity of cells to protect itself,” said Harald Hartweger, a research assistant professor in Michel Nussenzweig’s Laboratory of Molecular Immunology. “We wanted to take advantage of the immune system’s ability to amplify useful, rare cells.”
    • “The study, published in Science and titled “B lymphocyte protein factories produced by hematopoietic stem cell gene editing,” demonstrates that CRISPR‑edited HSPCs can mature into B cells that express engineered antibodies upon vaccination. A standard vaccination then acts as the trigger: antigen exposure drives those edited B cells to expand, differentiate into plasma cells, and secrete high titers of the inserted antibody that last long-term.”

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

  • Fierce Healthcare reports,
    • “The Purchaser Business Group on Health has released new data that highlights some of the key healthcare priorities of its jumbo employer members, with—perhaps unsurprisingly—the escalating affordability crisis as the biggest challenge.
    • “Rounding out the top three priorities are data analytics and transparency, as well as an interest in advanced primary care. PBGH based the findings of a survey of more than two dozens of its members, which represent some of the largest employers in the United States.
    • “Elizabeth Mitchell, president and CEO of PBGH, said in an interview that the escalating cost pressures have driven “a much more proactive approach from our members to address these concerns, which are simply not being addressed by the industry.”
    • “The urgency of that concern is absolutely growing,” Mitchell said. There is “also a heightened focus on transparency and understanding prices, and we are enabling that because they cannot just keep writing blank checks to the healthcare system when they have poor outcomes and just no demonstrable improvement in quality or value.”
  • Beckers Hospital Review informs us,
    • “Little Rock, Ark.-based Baptist Health reached a definitive agreement to acquire Magnolia (Ark.) Regional Medical Center.
    • “The deal, subject to customary regulatory approvals, is expected to be completed by July 12, according to an April 16 Baptist news release. On that date, the hospital will be rebranded as Baptist Health Medical Center-Magnolia.
    • “While it is an extremely challenging time to operate community hospitals, we have a proven track record of operating rural hospitals successfully in Arkansas,” Baptist President and CEO Troy Wells said in the release.”
  • and
    • “Mark Cuban has a pitch for hospitals: Manufacture drugs in their own parking lot.
    • “Mr. Cuban’s Cost Plus Drugs previously launched a Dallas-based manufacturing facility to address supply issues, starting with epinephrine and norepinephrine production. More recently, Mr. Cuban said his facility can also produce Pitocin, pediatric cancer drugs and sterile water — and that generic tablets can be cheaper when made in Dallas versus purchased from India.
    • “During Becker’s Spring 2026 Chief Pharmacy Officer Summit, Mr. Cuban explained how Cost Plus — which includes pharmacy, contracting, procurement and manufacturing businesses — is “modularizing” its manufacturing facilities.
    • “We’ve been able to take the manufacturing facility we have in Dallas and not only make it much smaller than what everybody else has done to that point, but we’ve been able to modularize them and put them in a pod that is effectively a tractor trailer,” Mr. Cuban said. “The trailers that go on the back that you see going down the road — we can manufacture sterile injectables in that tractor trailer.”
    • “Cost Plus is selling these manufacturing pods, which can be deployed anywhere from hospital sites to disaster zones to research facilities. He said rare disease therapies that historically cost upward of $500,000 and took six months to produce can now cost roughly $50,000 and possibly take less time.
    • “That, literally, over the long term, is going to be our biggest business and will save the most lives and money,” he said. “The more efficient we become at using robotics and AI, the less expensive we can manufacture drugs.” 
  • BioPharma Dive relates,
    • “Through an acquisition announced Friday, Belgian drug company UCB is wagering more than $1 billion on a cutting-edge medicine that’s being tested as a potential therapy for a few seizure disorders as well as Alzheimer’s disease.
    • “UCB offered to buy privately held Neurona Therapeutics for $650 million up front while dangling another $500 million in future, milestone-based payments. If completed, the deal would hand UCB an experimental therapy that uses pluripotent stem cells engineered to calm the brain and repair neural networks.
    • “The therapy, codenamed NRTX‑1001, is currently being evaluated in clinical trials as a treatment for patients with hard-to-treat forms of a common epilepsy rooted in the “mesial temporal lobe” part of the brain.”
  • and
    • “Kailera Therapeutics, a high-profile drug startup aiming to compete with Novo Nordisk and Eli Lilly in obesity, said Thursday it banked $625 million in one of the sector’s largest-ever initial public offerings.
    • “The IPO haul far surpasses the $500 million it set out to raise in terms set earlier this week. Kailera sold more than 39 million shares at $16 apiece. It’ll begin trading on the Nasdaq stock exchange on Friday under the ticker symbol “KLRA.”
    • “Kailera’s offering is among the biggest, by total proceeds, raised by a venture-backed biopharmaceutical company, according to BioPharma Dive data. Its IPO eclipses Acelyrin’s $540 million stock sale in 2023, Sana Biotechnology’s $588 million issuance in 2021, and Moderna’s then-record $604 million pricing in 2018.”
  • MedTech Dive lets us know,
    • “GE HealthCare is expanding a mammography collaboration with RadNet subsidiary DeepHealth.
    • “The partnership brings more of DeepHealth’s artificial intelligence tools to GE HealthCare’s mammography machines, including a workflow for complex cases that may benefit from a secondary review.
    • “The companies announced the expanded initiative at the Society of Breast Imaging Annual Symposium on Thursday.”

Thursday report

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

From Washington, DC

  • Roll Call reports,
    • “Senate Republicans plan to release a budget resolution next week that would kick-start the process for a reconciliation bill on immigration enforcement funding and help end a partial shutdown of the Department of Homeland Security, lawmakers said Thursday.
    • “The party is aiming to provide about $70 billion in funding for Immigration and Customs Enforcement and the Border Patrol to sustain them for at least the next three years, without placing any new guardrails on federal immigration agents sought by Democrats. The budget resolution would contain instructions to the Homeland Security and Governmental Affairs and Judiciary panels, which would be charged with writing the details of the upcoming reconciliation bill.
    • “Senate Majority Leader John Thune, R-S.D., said Thursday that the chamber is “hoping to get on a budget resolution by middle to end of next week.”
  • The American Hospital Association News relates,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. April 16 testified during two House hearings on the HHS fiscal year 2027 budget proposal, which requests $111.1 billion. He first appeared in a morning session held by the House Ways and Means Committee. In the afternoon, he testified during a hearing held by the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. Kennedy will appear in additional House and Senate hearings next week to testify on the budget proposal. 
    • “While the budget request is not binding, it serves as a preliminary framework for Congress and the administration as they determine federal funding levels and the scope of health care policy this year.”
  • The New York Times tells us,
    • “In a sharp break with his past rhetoric, Health Secretary Robert F. Kennedy Jr. offered a qualified embrace of the measles vaccine on Thursday, as President Trump named a new director of the Centers for Disease Control and Prevention whose views on vaccination are more conventional than Mr. Kennedy’s.
    • “In back-to-back hearings on Capitol Hill, Mr. Kennedy testified that the measles vaccine is safe and effective “for most people” and agreed it was safer than getting measles. Under questioning, he also allowed that the vaccine might have saved the lives of two unvaccinated children who died of measles in Texas earlier this year.
    • “His comments, while carefully couched, stand in stark contrast to his previous statements about vaccination. Coupled with Mr. Trump’s announcement of Dr. Erica Schwartz, a deputy surgeon general in his first administration, as his new pick for C.D.C. director, they provided the latest evidence yet that Mr. Kennedy is trying to publicly put his efforts to overhaul American vaccine policy behind him.”
  • The Washington Post adds,
    • “Kennedy highlighted efforts to phase out synthetic food dyes, overhaul dietary guidelines and strike deals with pharmaceutical companies. He said he planned to overhaul an influential task force focused on preventive screening recommendations. And he often appealed to his Make America Healthy Again base that doesn’t always fit within the Republican agenda, including saying he had “grave reservations” about a White House executive order boosting a commonly used weedkiller.
    • “Our children are the sickest generation in modern history — and decades of failed policy, captured agencies and profit-driven systems have caused it,” Kennedy said at Thursday morning’s hearing before the House Ways and Means Committee. “Parents across this country demanded change — and we are delivering it.”
  • The Wall Street Journal informs us,
    • ‘President Trump said Thursday he will nominate Dr. Erica Schwartz to direct the Centers for Disease Control and Prevention.
    • “The CDC has been without a permanent director since Susan Monarez wasousted last year after clashing with Health Secretary Robert F. Kennedy Jr.over vaccine policy.
    • “Schwartz served as deputy surgeon general, a nonpolitical role, in the first Trump administration. She has a medical degree from Brown University, as well as a master’s degree in public health and a law degree.” * * *
    • “Trump said he was also appointing three others to a team to help lead the CDC, including health executive Sean Slovenski; Commissioner of the Texas Department of State Health Services Dr. Jennifer Shuford; and Food and Drug Administration Principal Deputy Commissioner Dr. Sara Brenner.
    • “Kennedy voiced his support for the new team earlier Thursday in a hearing before a House subcommittee.”
  • The AHA News points out,
    • “The Centers for Medicare & Medicaid Services has released an updated request for applications for the Long-term Enhanced ACO Design Model, or LEAD. Applications are due May 17. The agency also announced that it will host an office hour April 21 at 1 p.m. ET for prospective applicants. CMS said it will address FAQs about eligibility, participation requirements, financial methodology, quality measures, and the application process and timeline. Participants can also submit questions in advance.”
  • Tammy Flanagan, writing in Govexec, discusses “when retirement calculations don’t move on the same timeline.”
    • “Retroactive pay changes and delayed annuity adjustments underscore how federal retirement processing often depends on timing, coordination, and most importantly, patience.”
  • Per an OPM news release,
    • “In a coordinated effort led by First Lady Melania Trump and the Administration for Children and Families (ACF), the Office of Personnel Management (OPM) today announced new actions to expand workplace flexibilities and support for foster and adoptive families across the federal workforce. 
    • “The initiative builds on Executive Order 14359, “Fostering the Future for American Children and Families,” and reflects a broader administration priority to help more children grow up in safe, stable, and loving homes.
    • “To advance these efforts, OPM is directing agencies to highlight key provisions in its Handbook on Leave and Workplace Flexibilities for Childbirth, Adoption, and Foster Care. Federal agencies are being mobilized to better connect employees with a wide range of workplace flexibility and benefits available when fostering or adopting a child. These include up to 12 weeks of paid parental leave, leave under the Family and Medical Leave Act, flexible work schedules, and other tools designed to help working families navigate major life transitions.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Eli Lilly’s new obesity pill Foundayo met the main goal of a heart safety trial in people with diabetes, putting people who take it at no greater risk of heart attacks and other cardiovascular events than people who received long-acting insulin, the company said Thursday.
    • “The Indianapolis-based drugmaker also said people who got Foundayo were at no greater risk of liver harm than those who got insulin, fulfilling a post-marketing requirement of the pill’s Food and Drug Administration approval for obesity. The trial additionally hinted that the pill might reduce the risk of death from any cause, although that finding would need to be confirmed in additional testing.
    • “Lilly said it will seek an approval for Foundayo in diabetes by the end of the second quarter and utilize a national priority review voucher that could lead to a speedy clearance. A regulatory OK in diabetes would open up a new front in a commercial war with Novo Nordisk, which has marketed a diabetes pill called Rybelsus since 2017.”
  • Cardiovascular Business relates,
    • “AOP Health, an Austrian pharmaceutical company, has secured U.S. Food and Drug Administration (FDA) approval for landiolol to be used for the treatment of supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter, in pediatric patients.
    • “Landiolol, sold under the brand name Rapiblyk, is an adrenergic receptor blocker that acts fast. It is only meant be administered as an intravenous infusion in a hospital setting. 
    • “In 2024, the drug was approved for adults after the FDA reviewed data from multiple randomized trials. This update to cover patients of all ages was based on the LANDI-PED study, which included 60 pediatric patients presenting with SVT. Overall, treatment with landiolol was linked to a reduction in ventricular rate of more than 20%.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement therapy (TRT) products to contact FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism (without a known cause).
    • “New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We are eager to work with sponsors to further evaluate this potential new use while upholding our rigorous standards for safety and effectiveness.” 

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Rotavirus, a seasonal virus similar to influenza, has been rising across the U.S. since January. With infection rates higher now than this time last year, doctors have fresh concerns that declining vaccinations could lead to more severe illness and a higher surge in the coming years. 
    • “The virus — which is spread by hands touching an infected surface, then touching the mouth — used to be a major cause of severe illness among babies and young children in the U.S., responsible for more than 200,000 emergency room visits, up to 70,000 hospitalizations and dozens of deaths each year, according to the National Foundation for Infectious Diseases. That drastically changed after the first oral vaccine was approved 20 years ago.
    • “Data from WastewaterScan, an academic program through Stanford University in partnership with Emory University, shows the virus has been surging since January, with levels continuing to increase in certain parts of the U.S., including the West and the Midwest. * * *
    • “We’re seeing a lot of rotavirus in wastewater right now, definitely very high levels and that indicates to us that there are high levels of rotavirus infections in these communities,” said Dr. Marlene Wolfe, WastewaterScan’s program director and co-principal investigator.”
    • The Centers for Disease Control and Prevention estimates that 40,000 to 50,000 hospitalizations among infants and young children are prevented every year due to the vaccines, which are given starting at 2 months of age. 
    • “Despite the data, earlier this year, Health and Human Services Secretary Robert F. Kennedy Jr. announced changes to the childhood immunization schedule, which included removing the rotavirus vaccine and telling parents they should talk to their doctor before deciding to vaccinate. 
    • “The virus is still circulating,” Offit said. “So a choice not to get a vaccine is a very real choice to experience that infection.” While the schedule changes were put on hold by a federal judge last month, doctors worry that even attempted moves to change the guidelines likely planted seeds of doubt among some new parents, who may now hesitate to vaccinate for rotavirus.”
  • MedPage Today adds,
    • “Despite tetanus being preventable with vaccination, cases continue to occur in the U.S., with deaths mostly affecting older adults, the CDC reported.
    • “From 2009 through 2023, there were 402 tetanus cases reported to the CDC in 47 states and the District of Columbia, with 16 states reporting 37 tetanus-associated deaths, wrote Michelle Hughes, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in Morbidity and Mortality Weekly Report Surveillance Summaries.”
  • Beckers Hospital Review relates,
    • “New York City-based NYU Langone Health researchers found that nearly 7% of trauma admissions are associated with pedal-powered and electronic bikes or scooters.
    • “The study, published April 15 in Neurosurgery, analyzed 914 patients treated over five years at a New York City-based Bellevue Hospital Center. Researchers found that the share of trauma cases involving an electric mobility device grew from under 10% in 2018 to more than half in 2023.”
  • The New York Times tells us,
    • “Since the approval of new Alzheimer’s drugs in recent years, there has been a lingering question: While data indicated that they could modestly slow cognitive decline for some patients, would that effect be meaningful or too slight to make difference?
    • “A new review of research spanning a decade, published on Wednesday, concluded that the clinical benefit of these and similar drugs is negligible. But the way the review was conducted spurred heated criticism from many Alzheimer’s experts, including some who had been skeptical of some of them.”
  • STAT News points out,
    • “The scientists whose work spurred the development of powerful obesity drugs like Eli Lilly’s Zepbound are now raising a provocative hypothesis: Perhaps targeting the GLP-1 hormone is actually not necessary to achieve effective weight loss.
    • “A group of researchers led by Richard DiMarchi and Matthias Tschöp has created an experimental drug that activates receptors of the GIP and glucagon hormones. They propose — based on rodent and monkey studies — that this kind of molecule, when administered at high enough doses, may result in weight loss comparable to the weight loss seen with drugs that include GLP-1 as a target, and without the tolerability issues like nausea and vomiting that often come with the approved treatments, according to a peer-reviewed draft paper published this week.
    • “The research, funded by a biotech called BlueWater Biosciences, would still need to be confirmed in humans; oftentimes results seen in animals don’t translate in the clinic. But the proposed approach, outlined in the journal Molecular Metabolism by some of the most well-known scientists in the field, is likely to stir controversy, as it challenges a central notion underpinning not just the development of approved obesity products but also next-generation versions.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “The University of Southern California (USC) research team that identified the hormone-encoding gene GDF15 as a key driver of pregnancy sickness has identified nine additional genes linked to its most severe form, hyperemesis gravidarum (HG). Six of the identified genes had not been previously linked to the condition.
    • “The Keck School of Medicine of USC team and international collaborators conducted a genome-wide association study (GWAS), scanning the entire genome for differences between women who developed HG during pregnancy and those who did not. They analyzed data from more than 10,000 women with the condition and more than 450,000 controls across European, Asian, African, and Latino ancestries. Their findings offer new clues about the condition and new hope for those affected.
    • “Marlena Fejzo, PhD, a clinical assistant professor of population and public health sciences in the Center for Genetic Epidemiology at the Keck School of Medicine, led the present study and earlier research linking GDF15 to HG. Fejzo told GEN, “The study is much larger than previous studies and on a more diverse population allowing for identification of new genes associated with HG … The new genes give us new directions to explore for prediction, diagnosis, treatment, and response to therapies.”
  • and
    • “In a new study published in Nature titled, “Mapping convergent regulators of melanoma drug resistance by PerturbFate,” researchers from The Rockefeller University have developed a platform called PerturbFate that can systematically map how diverse disease-associated genetic variations reshape cells. By tracking gene regulation in single cells over time, the team identified regulatory nodes common to diverse variations. Using melanoma drug resistance as a proof-of-concept, results showed that these shared points of control offer a path toward combination therapies that can target disease across many genetic causes.”

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

  • Cardiovascular Business reports,
    • “XCath Robotics, a Houston-based medical robotics company, announced the successful completion of the world’s first telerobotic stroke operation of its kind. Neurosurgeon Vitor Mendes Pereira, MD, chair of advanced neurovascular interventions at the University of Toronto, used the XCath Iris Surgical Robotic System to perform the historic procedure. While Pereira was in Santiago, Panama, the patient was approximately 120 miles away in Panama City.”
  • On a related note McKinsey & Co. interviews “Sam Hazen, CEO of HCA Healthcare, [who] reflects on the state of the industry and how emerging technologies and steadfast leadership can help meet patients where they are.”
  • Healthcare Dive relates,
    • “Walmart is expanding its digital health platform to include weight management services as the retail health giant looks to capitalize on consumer interest in GLP-1 weight loss drugs.
    • “The retailer’s digital health platform, called Better Care Services, can now connect patients to third-party weight management offerings from companies like Aaptiv and Curai Health. The providers can prescribe GLP-1s, while Walmart will handle prescription fulfillment, according to a Thursday press release.
    • “Walmart said the expansion should bridge the retailer’s pharmacy and digital health services, creating easier access to GLP-1s during a time of surging demand for the weight loss medications.”
  • Fierce Healthcare adds,
    • “More pharma companies are launching direct-to-consumer drug platforms and the rise of these self-pay services could improve access to medicines but also raise concerns about oversight and accountability.
    • “The Digital Medicine Society is leading a cross-sector effort, in partnership with pharma companies, virtual-first providers and digital pharmacies, to establish a scalable blueprint for direct-to-patient pharma models as the market continues to evolve.
    • “As Big Pharmas increasingly roll out platforms for direct-to-consumer drug sales, most offering steep discounts on popular medications, many patients are open to using the new services, Fierce Pharma Marketing reported. Three-quarters of U.S. consumers are “somewhat” or “very” likely to use DTC drug sale services, a survey found.” * * *
    • “The new initiative currently involves four leading pharma companies, with plans to add more. Founding partner companies involved in the initiative include Coalesce Health, DistributeRx, Fullspan Health, Health Advances, Phil, Inc., S3 Connected Health, Welldoc, Wheel and Ypsomed.”
  • and
    • “The American Psychological Association (APA)’s Labs division announced Tuesday the launch of a digital health resource guide for those seeking out mental health tools.
    • “The APA Labs Digital Badge Solutions Library is a searchable collection of resources and technologies that have earned the organization’s Digital Badge. Users can browse tools and applications related to behavioral health and wellness; clinical tools; family, pediatrics and monitoring and sleep, relaxation and mindfulness. 
    • “The library launched with “an initial cohort of early adopters” to meet independent evaluation demand, the announcement said. Six tools are currently in the library “with many more products in the evaluation pipeline,” APA Labs Managing Director Tanya Carlson told Fierce Healthcare in an emailed statement.”
  • Trilliant Health has posted its “2026 Behavioral Health Report.”
    • “An analysis of demand, supply and yield for behavioral health finds that the crisis has intensified in the years following the COVID-19 pandemic.”
  • AP lets us know,
    • ” A West Health–Gallup Center on Healthcare in America poll published Wednesday, conducted in late 2025 and backed up by at least three other recent surveys with similar findings, found that roughly one-quarter of U.S. adults had used an AI tool for health information or advice in the past 30 days.
    • “Dr. Karandeep Singh, chief health AI officer at the University of California San Diego Health, said AI tools, many of which now incorporate web search, are an upgraded version of Google health searches that Americans have been doing for decades.
    • “I almost view it like a better entry portal into web search,” he said. “Instead of someone having to comb through the top, you know, 10, 20, 30 links in a web search, they can now have an executive summary.”
  • Healthcare Dive adds,
    • “Abridge is expanding its clinical decision support tool through two partnerships with publishers of major medical journals, the AI scribe company announced Wednesday. 
    • “Under the deal, content from the New England Journal of Medicine and the JAMA Network will inform the AI’s responses when clinicians search for medical information and ask questions about patient care.
    • “The tool should allow clinicians to more easily access the latest medical research, Abridge said. “With the amount of complexity that exists in healthcare now, easy access to information for the right patient, the right moment, the right clinical conversation — it’s critical,” Matt Troup, clinical strategy principal at Abridge, said in an interview.”
  • Cardiovascular News notes,
    • “Stereotaxis, a St. Louis-based medtech company, has agreed to acquire Robocath, a major player in the field of robotic interventional cardiology technologies. 
    • “The deal includes an upfront payment of $20 million. Stereotaxis could pay up to an additional $25 million if certain regulatory and commercial milestones are met.
    • “Stereotaxis already specializes in robotic technologies used for a variety of minimally invasive endovascular procedures. Scooping up Robocath helps the company expand its offerings to include devices used for percutaneous coronary intervention (PCI) and other critical operations performed by interventional cardiologists in the cath lab. 
    • “Robocath is based in Rouen, France. The company’s flagship technology is the R-One+ system, a robotic system that helps cardiologists perform PCI, and work on a next-generation version of the R-One+ is already underway. Stereotaxis aims to ramp up work on that new technology once its acquisition is complete.”