Thursday report

Federal employment benefits

Thursday report

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

From Washington, DC

  • Roll Call reports,
    • “If and when the next government shutdown rolls around, the laundry list of consequences will now include a pay freeze for U.S. senators.
    • “On a voice vote, the Senate passed a resolution from Sen. John Kennedy, R-La., that requires the Senate secretary to withhold compensation for the duration of a shutdown.
    • “The change in Senate rules is set to take effect on the date of the 2026 midterm elections to comply with the 27th Amendment to the Constitution, which prohibits a change in congressional salaries from being enacted until after an intervening election.
    • “The speedy passage, which followed a 99-0 procedural vote Wednesday, underscored a growing frustration among lawmakers with the frequency of partial shutdowns.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services has released details on downloading its upcoming fiscal year 2025 Program for Evaluating Payment Patterns Electronic Report, or PEPPER, for critical access hospitals. The report, set to release this month, summarizes provider-specific Medicare data statistics for areas often associated with improper Medicare payments due to billing, diagnosis related group coding and/or admission necessity issues. CMS said the report would be available through its PEPPER Portal to authorized officials, access managers and users with the staff end user business function in the CMS Identity and Access Management System. A guide and FAQ on accessing the PEPPER are also available for users.”
  • Tammy Flanagan, writing in Govexec, advises federal and postal employees that “Waiting to retire could be worth thousands of dollars.”
    • “Before you rush out the door, consider how a few more years of service can permanently boost your FERS annuity and Social Security benefits.”
  • Fierce Healthcare informs us,
    • “A new ad campaign takes aim at the “misaligned incentives” in the No Surprises Act arbitration process, arguing they “create a ‘fox guarding the hen house’ dynamic.”
    • “The seven-figure campaign from the Coalition Against Surprise Medical Billing, called “Judge Fox,” features a court battle between a pair of chickens and a pair of foxes. The chickens confer and say that a “reasonable judge” would not allow these foxes to freely set prices for medical bills.
    • “Then the judge also turns out to be a fox, meant to illustrate that private equity firms that own providers that purportedly flood the dispute resolution system may also operate the independent entities meant to mitigate these disputes.
    • “The coalition said in a press release that the campaign comes “amid mounting evidence that some private equity-backed providers and IDR middlemen are relentlessly abusing the IDR process to maximize their own profits at Americans’ expense.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “A lawyer is leading the FDA for the first time, after President Donald Trump‘s selection Tuesday of Kyle Diamantas to serve as acting commissioner after Marty Makary resigned.
    • “The promotion of Diamantas to acting FDA commissioner also marks the second time in history someone leading the agency’s food oversight has been put in charge, a move that comes as the Trump administration advances a range of food policy changes aligned with the “Make America Healthy Again” movement.”
  • Fierce Pharma relates,
    • “BeOne Medicines has entered the BCL-2 arena, securing an FDA green light for Beqalzi that carves out a unique piece of territory ahead of a potential broader clash with market leader Venclexta.
    • “The FDA has granted an accelerated approval to BeOne’s Beqalzi (sonrotoclax) for the treatment of patients with relapsed or refractory mantle cell lymphoma after at least two prior lines of therapy, including a BTK inhibitor, the company said Wednesday.
    • “The go-ahead makes Beqalzi the first BCL-2 inhibitor specifically approved for MCL in the U.S., as AbbVie and Roche’s first-to-market Venclexta has only been used off-label for this type of blood cancer.”
  • and
    • “Taiho Pharmaceutical nabbed an expanded FDA approval for its Inqovi, which can now be taken alongside AbbVie and Roche’s Venclexa (venetoclax) to treat newly diagnosed acute myeloid leukemia in patients who are 75 and older and ineligible for intensive induction therapy. 
    • “The therapy is the first all-oral combination treatment regimen cleared for this specific patient population and represents an alternative to standard-of-care parenteral hypomethylating agent-based regimens, which require frequent visits to the clinic. With a more convenient offering that can potentially reduce the overall treatment burden associated with receiving the standard-of-care at hospitals or infusion centers, Taiho figures that its approach can make a “meaningful impact for patients and caregivers,” chief medical officer Harold Keer, M.D., Ph.D. pointed out in a company release.” 
  • BioPharma Dive tells us,
    • “An experimental Duchenne muscular dystrophy gene therapy from Regenxbio has met its main objective in a pivotal trial, positioning the company to seek an accelerated regulatory clearance in the U.S.
    • “Three months after treatment with Regenxbio’s therapy, RGX-202, 28 of the 30 study participants receiving muscle biopsies produced at least 10% of normal levels of a diminutive protein, “microdystrophin,” believed to help Duchenne patients. That result hit the trial’s main goal and passed a key threshold needed to support an approval. Nine volunteers with at least one year of follow-up also demonstrated statistically significant improvements, from the study’s start, on multiple tests of motor function.
    • “Regenxbio did report two serious adverse events among treatment recipients — one case of heart inflammation and another of asymptomatic liver injury. Both were “easily managed and resolved within weeks” without further incident, and the average levels of liver inflammation markers in those who got RGX-202 didn’t surpass the “upper limit of normal.” Still, company shares fell by more than 35% as the safety findings “muddy the update,” wrote Leerink Partners’ analyst Mani Foroohar.”

From the judicial front,

  • Per Justice Department news releases,
    • “A federal jury in the Southern District of Florida convicted the founder and owner of HealthSplash yesterday for his role in operating a platform that generated false doctors’ orders and prescriptions to defraud Medicare and other federal health care benefit programs out of more than $1 billion.” * * *
    • “According to court documents and evidence presented at trial, Brett Blackman, 42, of Johnson County, Kansas, and his co-conspirators aggressively targeted hundreds of thousands of Medicare beneficiaries to get them to accept medically unnecessary orthotic braces and other items. They then arranged for purported telemedicine doctors to sign bogus prescription orders for these items, so that their co-conspirators could bill Medicare for them. All told, Blackman and his co-conspirators billed Medicare and other federal health care benefit programs over $1 billion for this unnecessary equipment.
    • “Blackman owned, controlled, and was the CEO of HealthSplash, which acquired Power Mobility Doctor Rx, LLC (DMERx) in September 2017. DMERx was an internet-based platform that generated false and fraudulent doctors’ orders for durable medical equipment (DME) and prescriptions for other items. As part of the scheme, Blackman and his co-conspirators connected pharmacies, DME suppliers, and marketers with telemedicine companies that would accept illegal kickbacks and bribes in exchange for signed doctors’ orders created using the DMERx platform. Blackman and his co-conspirators took a cut for themselves in exchange for the referrals.”
  • and
    • “Takeda Pharmaceuticals, U.S.A. Inc. has agreed to pay $13,670,921 to resolve allegations that it knowingly caused the submission of false claims to Medicare and other federal health care programs by paying kickbacks to healthcare providers to induce prescriptions of Trintellix, an antidepressant medication that Takeda marketed and sold to treat major depressive disorder.”
    • “The Department of Justice is committed to vigorously pursuing violations of the False Claims Act arising from illegal kickbacks,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “Such conduct can erode the trust that patients place in their healthcare providers and lead to higher drug costs for American taxpayers.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Health officials in the United States and around the world are assessing and managing potential exposures linked to the hantavirus outbreak on an expedition ship. Some of the American passengers on the ship are quarantining in Nebraska and Georgia. Others returned home earlier.” * * *
    • “David Fitter, the Centers for Disease Control and Prevention official leading the response, told reporters Thursday during a media briefingthat 41 people across the U.S. are under monitoring, but there are no cases.
    • “The people being monitored for symptoms fall into three groups. The first are the 18 passengers who were recently flown back to the United States from the Canary Islands and are being monitored in special facilities in Nebraska and Georgia. The second group comprises passengers who had already left the ship and returned home before the outbreak was identified. 
    • “In the third group are people who may have been exposed during flights with a known and symptomatic patient. That patient was the wife of the Dutch man, the first known patient to became sick, who died April 11 on board the ship. She left the ship and flew to Johannesburg, where she died on April 26.”
  • Per a National Institutes of Health news release,
    • “A scientific team funded by the National Institutes of Health (NIH) has isolated and mapped in detail the first comprehensive group of human antibodies targeting the measles virus. The findings reveal previously unknown details about how the human immune system fights measles and identify specific antibodies capable of reducing the virus to undetectable levels in an animal model. The research could serve as the foundation for development of a measles treatment.
    • “Measles cases have recently increased in the United States and worldwide. More than 470,000 measles cases were reported globally in 2024, and at least 72 outbreaks have been recorded in the United States since January 2025. While effective prevention in the form of vaccination is available, no safe and effective therapies have received regulatory approval in the United States. This leaves people who cannot safely receive the vaccine – the immunocompromised, pregnant women, and infants too young to be vaccinated – with a lack of medical options.
    • “With measles cases increasing, we urgently need effective therapeutics to protect the most vulnerable,” said Jeffrey K. Taubenberger, M.D., Ph.D., acting director of NIH’s National Institute of Allergy and Infectious Diseases. “This research gives us a clear picture for the first time of the most promising targets for antibody-based medicines that could protect or treat people for whom measles vaccination is not an option.”
  • Medscape tells us,
    • “Two new studies have identified risk factors that may be associated with the increasing incidence of colorectal cancer (CRC) among younger Americans.
    • “The majority of cases are sporadic, suggesting modifiable, nongenetic factors may play an important role,” said Mohamed Eldesouki, MD, internal medicine resident at New York Medical College at Saint Michael’s Medical Center in Newark, New Jersey, at Digestive Disease Week (DDW) 2026.
    • “In the first study, Eldesouki and colleagues identified a distinct phenotype, based on multiple factors, associated with an elevated risk in people aged 18-49 years. In addition, they found that inflammatory bowel disease, family history of CRC, severe obesity, and obesity were independent predictors that increased the risk for early-onset vs late-onset CRC more than twofold.
    • In the second study, a history of oral antibiotic exposure was associated with an increased risk for colorectal adenomas, especially among people with a greater or longer history of using these agents.”
  • Med Page Today informs us,
    • “Dementia with Lewy bodies — a disease characterized by faster progression and greater functional decline than Alzheimer’s disease — was confirmed as a predominantly late-onset dementia with incidence rising sharply with age, a systematic review and meta-analysis showed.
    • “Across 12 population-based studies, the pooled incidence was 46.85 per 100,000 person-years (95% CI 23.78-92.30) for people ages 65 and older, and the pooled prevalence was 352.26 per 100,000 population (95% CI 112.25-1,099.79), reported Daniele Urso, MD, MPH, of the University of Bari Aldo Moro in Italy, and co-authors in JAMANeurologyopens in a new tab or window.
    • “In people younger than 65, the pooled incidence was 0.34 per 100,000 person-years (95% CI 0.14-0.83) and the prevalence was 2.52 per 100,000 population (95% CI 1.43-4.44).”
  • Health Day points out,
    • “Women entering menopause are twice as likely to have lower heart health scores than those still having regular periods, a new study says.
    • “Perimenopausal women are more likely to have high cholesterol and blood sugar levels, researchers reported today in the Journal of the American Heart Association.
    • “These problems likely are fueled by varying estrogen levels, which can negatively affect cholesterol, insulin resistance, blood pressure and weight, researchers said.
    • “But diet also plays a powerful role, with women’s healthy nutrition scores declining as they begin and then enter menopause, the study found.
    • “Mid-life women should think of the perimenopausal period as a ‘window of opportunity.’ They should be proactive and not wait until they reach menopause to start checking their blood pressure, cholesterol and blood sugar levels,” said senior researcher Dr. Garima Arora, an professor of medicine at the University of Alabama at Birmingham.”
  • and
    • “Abdominal obesity (AO) is associated with a higher prevalence and greater severity of menopausal symptoms, according to a study published online May 5 in Menopause.” * * *
    • “Educating women early about healthy lifestyle interventions to prevent midlife weight gain is key to improving mental and physical well-being during a tumultuous time frame,” Monica Christmas, M.D., associate medical director for The Menopause Society, said in a statement.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Companies such as UnitedHealth Group, CVS Health, Cigna and Centene recorded strong first quarters.
    • “Earnings reports suggest chronically high medical costs may be subsiding.
    • “Insurers outperformed Wall Street expectations and upgraded earnings guidances, driving share prices higher.
    • “Seasonal factors, a shift toward higher-deductible plans and incomplete claims data cloud insights into cost trends.”
  • and
    • “UnitedHealth Group division Optum Rx has rolled out a new pharmacy benefit manager model the company describes as transparent.
    • “Optum Rx, first in PBM market share, will phase out practices tying revenue to drug prices and shift toward fees.
    • “The company is attempting to respond to criticisms from its customers, the public and policymakers about how PBMs operate.
    • “Chief rivals CVS Caremark and Express Scripts previously announced similar changes.”
    • * * * “The fact that we’re having this discussion shows progress,” said Robert Andrews, CEO of the Health Transformation Alliance, a coalition of large employers that lobbies Congress.”
  • The Wall Street Journal relates,
    • “Much of the public debate over cancer blood tests has focused on early detection products like the Galleri test from a company called Grail, which promises to screen healthy people for more than 50 types of cancer. 
    • “While these tests capture headlines and Super Bowl ads, the more proven opportunity for investors has been in a less glamorous market: checking for cancer recurrence.
    • For a patient who has just had a tumor surgically removed, the critical question is whether every cancer cell is gone. Many oncologists now use blood tests to answer that question months before a traditional scan could. 
    • “Natera NTRA, based in Austin, Texas, holds a near-monopoly in this market, known as minimal residual disease (MRD) testing. Its stock has roughly quadrupled over three years. The company is now valued at about $31 billion, making it the dominant player in what may be a new era of blood-based cancer testing. It has even surpassed Illumina, the sequencing giant on whose technology much of the industry depends. Revenue has grown from roughly $1 billion in 2023 to $2.3 billion last year and is projected by analysts on FactSet to reach $2.77 billion this year.”
  • and
    • “Merck KGaA lifted its full-year sales and earnings guidance, causing its shares to rise 8.2% in European midday trading.
    • “The company now forecasts net sales of 20.4 billion to 21.4 billion euros and organic sales growth of up to 3%.
    • “Merck cited strong momentum in its life-sciences unit and greater resilience in its healthcare division for the improved outlook.”
  • and
    • “State laws restricting private-equity involvement in the medical sector have taken their first scalps, as authorities signal an aggressive approach to enforcement.
    • “Last year, lawmakers in California and Oregon passed measures to prevent corporate healthcare investors from encroaching on medical care, part of a broad backlash against private equity’s role in the sector.
    • “The new laws started to bite last week. In California, Attorney General Rob Bonta unveiled the first settlement for violating the new law, penalizing Aspen Dental Management, which is backed by asset managers Leonard Green & Partners and Ares Management.
    • “Just a day earlier, Oregon hospital operator PeaceHealth scrapped plans to bring in an out-of-state medical-staffing company after a federal judge said the move looked like an end-run around the state’s strictest-in-the-nation ban on corporate medicine.”
  • Beckers Hospital Review tells us,
    • “Becker’s has compiled a list of the hospitals with a CMS 5-star rating for cleanliness.
    • “CMS’ Patient survey (HCAHPS)-Hospital database listed hospital ratings based on the Hospital Consumer Assessment of Healthcare Providers and Systems surveys. This is a national, standardized survey of hospital patients about their experience during a recent inpatient hospital stay. The surveys were completed between July 1, 2024, and June 30, 2025. The data was updated May 13. 
    • “In 2025, 374 hospitals had a five-star cleanliness rating and Wisconsin had the most highly rated hospitals for cleanliness at 30.
    • “This year, 22 more hospitals made it to 5-star ratings, and Texas had the hospitals recognized for cleanliness with 36.”
    • The article includes the list.
  • and
    • Americans are unlikely to see generic versions of semaglutide — the active ingredient in Novo Nordisk’s Ozempic and Wegovy — until at least the end of 2031, according to a May 13 NBC News report.
    • Novo Nordisk first applied for a U.S. patent on semaglutide in 2006. While standard drug patents last 20 years, patent extensions and secondary patents have delayed generic competition in the U.S., experts told NBC News.
  • and
    • “Lentocilin, a penicillin G benzathine product, is back in stock and available to hospitals, clinics and pharmacies nationwide on Cost Plus Drugs’ marketplace.
    • “The restock comes as healthcare organizations continue managing supply disruptions affecting penicillin G benzathine products across the market, according to a May 11 company news release.
    • “Penicillin G benzathine is the only recommended treatment for syphilis during pregnancy and for preventing congenital syphilis — a condition whose national diagnosis rate has risen 203% over five years, according to an alert from the New Mexico Department of Health. The branded equivalent, Bicillin L-A, has been in shortage since 2023 and was further disrupted by a Pfizer recall in July 2025 due to particulates in prefilled syringes.” 
  • MedTech Dive points out,
    • “Johnson & Johnson has launched a new iteration of its Shockwave coronary intravascular lithotripsy catheter that is designed to make it easier for physicians to treat complex calcified lesions and restore blood flow in the arteries.
    • “Called Shockwave C2 Aero, the improvements in the fifth-generation platform are intended to allow clinicians to use the catheter in a broader range of cases. 
    • “The device is available in the U.S. and Japan and will be introduced in Europe and Canada in the coming months, J&J said Tuesday.”
  • Beckers Payer Issues discusses “How AI is turning UnitedHealth, CVS and Elevance into software companies.”

Monday report

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

From Washington, DC,

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

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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


Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday report

David Ermer–FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “In the coming months, the Office of Personnel Management is expected to release a reworked version of its employee viewpoint survey that’s more focused on granular data and delivering realtime feedback.
    • “OPM Director Scott Kupor said his agency has been refining the survey to focus more on micro-level questions in order to more effectively gauge employee opinion.
    • “The goal is to get to a decision on what the kind of new survey format looks like so that we have time to do something over the course of this fiscal year for sure,” Kupor told Federal News Network in an interview Wednesday.”
  • Fedweek outlines the FEHB/PSHB eligibility rules for children.
    • “Both the Federal Employees Health Benefits program and Postal Service Health Benefits program, provide for coverage of spouses and children in their self plus one and family options. While enrollment changes typically happen during the open season each autumn, there are certain life events that involve adding children—for example from self plus one to self and family on the birth or adoption of a child.
    • “In both cases, it’s important to know who qualifies for coverage as a child, and when that may end.’
  • Thompson Reuters notes,
    • “QUESTION: We recall that the Affordable Care Act (ACA) requires insured group health plans to satisfy nondiscrimination rules similar to those that apply to self-insured plans under Code § 105(h) (the eligibility and benefit tests). What is the status of those rules? Are employers that sponsor insured plans required to comply with them, and if so, when?
    • “ANSWER: Under the ACA, insured group health plans generally must satisfy the nondiscrimination rules of Code § 105(h)(2), including “rules similar to” those in Code § 105(h) regarding nondiscriminatory eligibility, nondiscriminatory benefits, and controlled groups. The Code § 105(h) rules pre-date the ACA, prohibit certain discrimination in favor of highly compensated individuals, and apply only to self-insured health plans. The ACA applied similar requirements to insured plans, other than those that provide only excepted benefits or qualify for grandfathered status.
    • “Although insured group health plans initially were required to comply with the ACA nondiscrimination rules for plan years beginning on or after September 23, 2010, the IRS announced in Notice 2011-1 that compliance is not required until the agencies issue regulations or other guidance regarding how the rules apply to insured plans. To date, the agencies have not issued such regulations or guidance, so sanctions for failure to comply do not yet apply for insured plans. Note that the Code § 105(h) nondiscrimination rules continue to apply to self-insured health plans, including those that provide excepted benefits or are grandfathered. For example, the Code § 105(h) nondiscrimination rules continue to apply to health FSAs”.
  • Per an HHS news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced an Interim Final Rule (IFR) extending, for one-year, the compliance dates that recipients of HHS funding must meet for conforming web content and mobile applications to specific accessibility standards under Section 504 of the Rehabilitation Act of 1973 (Section 504).
    • “Under the revised timeline:
      • “Recipients with 15 or more employees will now have until May 11, 2027, to comply.
      • “Recipients with fewer than 15 employees will now have until May 10, 2028, to comply.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “After a surprise rejection at the beginning of 2026, the FDA has agreed to reconsider a T-cell therapy based on the same single-arm trial that the agency had previously found problematic.
    • “For Pierre Fabre Pharmaceuticals and Atara Biotherapeutics’ Ebvallo, the FDA agreed during a recent meeting that a single-arm study using an appropriate historical control “could serve as an adequate and well controlled study” in support of an application for approval, the two companies said Thursday.
    • “Pierre Fabre and Atara are aiming to get Ebvallo, also known as tabelecleucel or tab-cel, approved for patients with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+PTLD) who have failed on an anti-CD20 regimen. Before the FDA, European regulators had already greenlighted the immunotherapy for the indication in 2022.”
  • MedPage Today adds,
  • and
    • “An investigational trivalent mRNA-based vaccine reduced confirmed flu illness by 26.6% through the end of the flu season compared with approved standard-dose vaccines in a randomized trial among adults ages 50 and older.
    • “The mRNA vaccine led to more adverse events, particularly injection-site pain and fatigue, but most were transient and mild without an excess of more serious risks.
    • “An FDA decision on approval is expected by August.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Using the blood of a 56-year-old woman vaccinated against measles, scientists have isolated a fighting force of four potent virus-blocking antibodies that could pave the way toward a treatment for people exposed to the highly contagious respiratory disease making a comeback in the United States.
    • “A safe, highly effective vaccine for measles has been available since the 1960s, and the U.S. officially eliminated the disease in 2000, with sporadic cases and outbreaks. But dropping vaccination rates have sparked large outbreaks in multiple states, and the country is edging closer to the virus spreading freely again—which puts more people at risk.
    • “New ways to block or treat measles would be particularly important for people who are immunocompromised and babies under the age of 1, because they are not eligible for the vaccine, leaving them unprotected amid a growing number of cases.
    • “Measles was a problem that was solved. Until it wasn’t solved anymore,” said Erica Ollmann Saphire, president of the La Jolla Institute for Immunology who led the study published Thursday in the journal Cell Host & Microbe. But she and other scientists stressed that this approach was not a substitute for a vaccine.
    • “The treatment is always going to be more expensive than the vaccine. It’s the best bang for your public-health buck — this is for people that couldn’t be vaccinated,” Saphire said.”
  • MedPage Today adds, “A new systematic review in The BMJ reported that current evidence did not support causal associations between aluminium adjuvanted vaccines and serious or long-term health outcomes.“
  • Infectious Disease Advisor notes,
    • “HIV pre-exposure prophylaxis (PrEP) uptake remains suboptimal among commercially-insured adolescents and young adults in the United States, highlighting the need for targeted interventions to address access barriers.”
  • The American Medical Association lets us know what doctors wish their patients knew about swimmer’s ear.
    • “Diving into pools or spending the day at the beach or lake can be the epitome of summer fun, but these aquatic adventures can also come with an unwelcome companion: otitis externa, commonly known as swimmer’s ear. This common affliction can sideline even the most dedicated water enthusiasts with its painful consequences. With the incidence of swimmer’s ear rising during the warmer months, understanding its causes, symptoms and prevention methods is essential for water enthusiasts of all ages.” 
  • The National Institute for Health Care Management’s May newletter discusses “Cancer Trends & Treatment Advancements”
  • Per BioPharma Dive,
    • “CellCentric, a biotechnology company developing an experimental drug for multiple myeloma, announced Wednesday it raised a $220 million Series D round to finance mid- and late-stage trials.
    • “Its lead drug, dubbed inobrodib, is an oral medicine that blocks a pair of proteins called “p300” and “CBP,” which in turn prevents the expression of certain key cancer-driving genes. CellCentric believes the treatment might be useful as an additive therapy across different lines of care in multiple myeloma. 
    • “The biotech is testing inobrodib in an all-oral combination involving Bristol Myers Squibb’s Pomalyst, as well as in conjunction with bispecific antibodies for myeloma such as Pfizer’s Elrexfio and Johnson & Johnson’s Tecvayli. It’s also evaluating use in a “maintenance” setting, where treatments are used to keep cancer from returning.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Blue Shield of California debuted its virtual-first Virtual Blue healthcare plan just over three years ago. Now, the data is rolling in.
    • “The program began in 2023 through a collaboration with tech-enabled healthcare platforms Accolade — now owned by Transcarent — and TeleMed2U. The program has no out-of-pocket costs for visits with virtual-only providers, can often deliver same-day care and now has more than 150,000 members. Blue Shield is even tacking virtual primary care options onto its Trio HMO plan, expanding offerings into the individual market.
    • “Tim Lieb, Blue Shield of California’s senior vice president of commercial markets, recently joined the “Becker’s Payer Issues Podcast” to discuss Virtual Blue’s early strengths and challenges.”
  • Healthcare Dive relates,
    • “Nearly 8 in 10 employers report GLP-1 drugs are driving heightened healthcare costs at their companies, pushing some to consider dropping coverage of the pricey weight loss medications, according to a survey released Tuesday by the Business Group on Health.
    • “Only 72% of employers that cover GLP-1s for weight management said they’d likely maintain that coverage next year, while 10% reported they likely wouldn’t, according to the group, which represents employers that provide health coverage. 
    • “Additionally, 87% of respondents said new oral versions of GLP-1 drugs would result in higher demand for the medications, but only 9% predicted prices would decrease.”
  • and
    •  Providing hospital-level care in patients’ homes was linked to better clinical outcomes, suggesting hospital-at-home programs could serve as a safe and efficient alternative to traditional inpatient care, according to a study published this week in JAMA Network Open. 
    • Hospital at home was associated with decreased emergency department use within 30 days of discharge and lower in-hospital mortality, according to the research. But patients at hospital-at-home programs saw no significant difference in hospital readmissions within 30 days. 
    • Additionally, adoption of hospital at home across the country is uneven, with few rural facilities participating, researchers wrote. The findings “underscore the need to address practical and implementation challenges to broaden equitable access,” they said.
  • Per Healthcare Cost Institute news releases,
    • Health care spending can differ dramatically depending on where Americans live, with costs varying by more than twofold from one metro area to another, according to new findings from the Health Care Cost Institute (HCCI). Charleston, WV, tops the list of the highest spending markets, with annual costs more than twice those in places like Bakersfield, CA, one of the country’s lowest spending areas.
    • The new data comes from the Health Cost Landscape, HCCI’s updated interactive platform that compares health care spending, prices, service use, and market dynamics across 269 metro areas in 45 states. The tool gives a clear, local look at how health care markets function and where consumers are paying the most for care.
  • and
    • “The Transparency in Coverage (TiC) regulations have introduced unprecedented visibility into negotiated health care prices in the United States. By requiring insurers to publish machine-readable files containing payer–provider contracted rates starting in 2022, the policy has created a new data source for studying price variation. However, the scale, inconsistency, and missing information within the TiC data mean that rigorous methodological work is required before it can be used for research. This brief explores the nature of this data, how it is accessed and processed, and how it can be used for analysis, with a detailed walkthrough of a real example examining childbirth prices in Pennsylvania.” * * *
    • “Transparency in Coverage data represent a significant advancement in the availability of information on negotiated health care prices, offering researchers a new lens into variation across payers, providers, and markets. As demonstrated in the childbirth analysis in Pennsylvania, TiC data can be used to replicate and extend findings from traditional claims-based research, particularly in understanding the range and distribution of negotiated rates across payers and providers.
    • “At the same time, the value of TiC data depends heavily on the methods used to create an analytic dataset. The raw data are not inherently research-ready and require substantial processing, including careful service definition, data cleaning, provider and payer entity resolution, and restrictions to ensure comparability. Without these steps, analyses may not be replicable and risk reflecting the messiness of the raw data rather than meaningful differences in prices. Additionally, the absence of utilization data remains a fundamental limitation, requiring integration with external sources to fully assess spending and average prices.
    • “Overall, TiC data should be viewed as a powerful but incomplete resource. When used appropriately, they can provide important insights into health care pricing dynamics and market structure. As data quality improves and methods continue to evolve, TiC data are likely to become an increasingly valuable complement to claims data in health services research.”
  • Per Fierce Healthcare,
    • “Hims & Hers launched an artificial intelligence agent embedded in its platform to help interpret biomarker lab results and provide users personalized insights about their health.
    • “The company launched its direct-to-consumer lab testing program for health biomarker testing back in November. The new agent AI, Labs AI, has been available to some customers in beta testing and will roll out to all Labs customers over time, the company announced Thursday.
    • “Hims & Hers’ Labs offers access to 130 biomarker tests across 10 health areas, including heart health, metabolism, hormones, inflammation and stress, as part of its strategy to extend into prevention and health screening. The new AI care agent makes customers’ lab results clearer, more useful and easier to engage with, according to Patrick Carroll, M.D., Hims & Hers chief medical officer.”
  • and
    • “Ardent Health topped the market’s revenue and earnings estimates, touting Wednesday solid adjusted admission and labor spend numbers despite what has proved to be a tumultuous first quarter for hospitals. 
    • “The publicly traded for-profit logged $1.6 billion of total revenue, which was up 7% year over year and 1.3% above Zacks Investment Research’s consensus estimate. Net income was $40 million, or 28 cents per share, beating the consensus estimate of 18 cents per share. 
    • “Similar to other for-profit health systems’ reports from the past few weeks, executives acknowledged the impacts of a weak respiratory season and severe winter storms on Ardent’s business, particularly in Texas, Oklahoma and New Jersey. That led to a 1.1% year-over-year decline in admissions, though CEO Marty Bonick said during Wednesday’s earnings call that the company “acted swiftly to reschedule surgeries and adjust labor to align with volume, mitigating the impact on our performance.”
  • Per Fierce Pharma,
    • “With an eye on the lucrative U.S. market, Italy’s Angelini Pharma will acquire rare disease specialist Catalyst Pharmaceuticals and its potential blockbuster, Firdapse, for $4.1 billion.
    • “Rome-based Angelini, a family-owned private company established in 1919, is paying $31.50 per share for Florida-based Catalyst. It is a 3% premium on Catalyst’s share price at close yesterday and a 21% premium on its price on April 22 before market activity hinted at public knowledge that a sale was in the offing. Bloomberg reported the potential buyout on April 27, triggering another stock surge.”
  • Per MedTech Dive,
    • “Roche has agreed to acquire PathAI, a Boston-based digital pathology firm, for up to $1.05 billion.
    • “Roche plans to pay $750 million upfront and up to $300 million in additional milestone payments, according to a Thursday announcement. 
    • “The acquisition is expected to close in the second half of 2026, subject to customary closing conditions, including antitrust and regulatory approvals.”

Tuesday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Fierce Healthcare reports,
    • “Another top Republican lawmaker is floating plans to overhaul the Current Procedural Terminology, or CPT, code system. 
    • “Rep. James Comer, R-Kentucky, who chairs the House Committee on Oversight and Government Reform, penned a letter late last week to the Centers for Medicare and Medicaid Services seeking information on the CPT code system’s complexity and whether its structure is facilitating improper billing such as upcoding or unbundling. 
    • “Further, he asked the agency to describe “any constraints—statutory, regulatory or operational—that limit CMS’ ability to modify or move away from the current CPT-based system.” 
    • “The questions come as one of Comer’s colleagues in the Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy, M.D., R-Louisiana, has placed a magnifying lens on the American Medical Association (AMA) over the millions in revenue it collects managing, and advising on, the CPT code system (see that coverage below the break).
    • “Comer’s approach was less combative, and his letter to CMS does not directly place blame on the AMA. Still, it notes that Medicare and Medicaid’s codified use of the association’s proprietary system “raises concerns about federal reliance on a privately owned and licensed coding system. These concerns include fundamental questions about transparency, cost control, and whether federal healthcare policy is shaped in the best interest of patients, or by entities with financial incentives tied to the system’s continued complexity.” 
  • Kevin Moss, writing in Govexec, “weighs the costs and trade-offs of suspending FEHB for Medicare Advantage.”
  • CMS Administrator Dr. Mehmet Oz lets us know,
    • “Last year, the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS) announced a landmark pledge with major health plans from across the country to streamline and improve the prior authorization process across the entire health care industry. This pledge reflects a shared commitment to modernizing prior authorizations to create a more responsive, patient-centered experience. 
    • “Since then, the health care industry has already begun delivering results. For example, leading health plans announced in April that they eliminated 11% of prior authorizations across a range of medical services, representing 6.5 million fewer prior authorizations for patients. Other plans are rapidly scaling standardized processes and reducing requirements, demonstrating that meaningful change is not only possible—it’s happening. For example, one large national plan is eliminating authorization requirements for 30% of healthcare services and has committed to removing an additional 30% of remaining requirements by the end of 2026. 
    • “CMS is proud to announce the next chapter of that commitment: adding electronic prior authorization to the Health Tech Ecosystem. The initial landmark pledge effort brought the nation’s major health plans to the table. This new initiative brings everyone else. Health systems, hospitals, physician practices, electronic health record (EHR) vendors, and digital health developers are now joining payers as a unified coalition aligned around a single mission: making electronic prior authorization work end-to-end, on time, for every patient.” 
  • The Wall Street Journal adds,
    • “UnitedHealth Group plans to stop requiring doctors to get approvals for an array of procedures, tests and services, cutting back on a process that has long been detested by physicians and patients.
    • “UnitedHealth, parent of the biggest U.S. health insurer, said the changes will slash the number of reviews by nearly a third starting later this year. Doctors have long complained about the paperwork they must complete to get insurers’ permission for care, which can lead to delays and denials.
    • “UnitedHealthcare will stop requiring signoffs for tests including echocardiograms, some chiropractic care and certain outpatient surgeries. Also on the list is some outpatient therapy.
    • “The insurer said it is using technology backed by artificial intelligence to help reduce the need for pre-authorization reviews.
    • “The rollback is part of an effort by health insurers to counter a backlash against pre-authorizations. Rivals like CVS Health’s Aetna and Cigna Group have also made moves to ease these types of reviews.”
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced the launch of its Intelligent Generator of Research (IGoR) program, a systemic effort to deliver gold-standard biomedical science faster. The program will accelerate breakthroughs with a next-generation, AI-powered research ecosystem built to expand the experimental capabilities available to researchers. Crucially, the system will continuously refine advanced models of complex and chronic health conditions that impose a growing burden on Americans and the U.S. health system.” * * *
    • “For centuries, intrepid scientists have discovered amazing insights about health and disease. Yet, as frontier problems become more complex, the speed of discovery has been limited by what information and experimental capabilities are at researchers’ fingertips,” said IGoR Program Manager Paul E. Sheehan, Ph.D. “Through ARPA-H’s new IGoR program, we can amplify human creativity by reimagining the research ecosystem and empowering our scientists to answer ever more challenging questions about medicine’s unsolved mysteries.”
    • “The IGoR program will span 5 years. ARPA-H will solicit proposals under its Innovative Solutions Opening (ISO) and encourages collaboration among experts across disciplines to meet the program’s ambitious goals.” * * *
    • “For more information, including solicitation details and Proposers’ Day registration for this funding opportunity, visit the IGoR program page.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration (FDA) today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway. Each product is an e-liquid pod containing 50mg/ml (or 5%) of tobacco-derived nicotine. The authorized pods include Classic Menthol, Fresh Menthol, Gold, and Sapphire. This action marks the FDA’s first authorization of non-tobacco and non-menthol ENDS products.
    • “Smoking is the leading preventable source of chronic disease and premature death in the U.S. Last year, one in five deaths resulted from cigarette smoking.  More than 25 million Americans External Link Disclaimer still smoke combustible cigarettes, and they deserve better, less harmful alternatives. Under President Trump’s leadership, the FDA has authorized a number of less harmful alternatives for smokers, including 11 ENDS products from American companies.”

From the judicial front,

  • Modern Healthcare reports,
    • “A California hospital trade group sued to stop Elevance Health from implementing a policy that would cut payments to hospitals that refer some members to out-of-network providers. 
    • “In a complaint filed Monday in the state Superior Court of Los Angeles County, the California Hospital Association contended the policy allegedly violates state consumer protection and healthcare laws.” * * *
    • “Starting in June, Elevance Health plans to reduce California hospitals’ payments by up to 10% if they refer commercial patients to out-of-network physicians. 
    • “The Blue Cross Blue Shield licensee has introduced similar versions of the policy in at least 12 other states where it operates Anthem Blue Cross Blue Shield commercial plans. 
    • “The policy is intended to lower commercial healthcare costs, an Elevance Health spokesperson said in a statement. The spokesperson also said some out-of-network providers abuse the federal arbitration process enacted under the No Surprises Act of 2020.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The World Health Organization said human-to-human hantavirus transmission is possible on a cruise ship.
    • “A suspected hantavirus outbreak on the MV Hondius led to three deaths and four other infections among 147 people on board.
    • “The WHO assumes the hantavirus is the Andes variant, known in Argentina, where initial patients boarded the ship.”
  • The New York Times lets us know what doctors want you to know about cannabis and health.
    • “The government recently loosened medical marijuana rules. Experts separate fact from fiction about the drug’s safety and benefits.”
  • MedPage relates,
    • “New research is raising alarms about inhalants, which are often portrayed online as harmless while putting teens at real risk.
    • “Two new studies point to a troubling pattern: Younger teens, especially girls, may be more vulnerable — and social media is a major source of exposure.
    • “In one study, recently published in the Journal of Studies on Alcohol and Drugs, researchers reviewed 30 videos about nitrous oxide — often called “laughing gas” — posted in early 2025.
    • “Those videos averaged 23 million views. Some showed how to use it, with no age restrictions or health warnings. Others promoted “free trials” of nitrous oxide products, highlighting how easy and accessible these substances can be for teens.
    • “Inhalants remain one of the least-studied and least-discussed substance-use categories, despite the seriousness of their health risks,” said lead author Rachel Hoopsick, an assistant professor of health and kinesiology at the University of Illinois Urbana-Champaign.”
  • and
    • “Maternal respiratory syncytial virus (RSV) vaccination and infant nirsevimab immunization, administered alone or sequentially, are safe and effective, according to a study published online May 4 in Pediatrics.
    • “Christina A. Rostad, M.D., from the Emory University School of Medicine in Atlanta, and colleagues conducted a randomized, open-label phase 4 study at eight U.S. sites of mother-infant pairs to examine administration of maternal RSV prefusion F vaccination (RSVpreF) and infant nirsevimab immunization. Pairs were randomly assigned during pregnancy to receive maternal RSVpreF vaccine alone, maternal RSVpreF vaccine/infant nirsevimab at birth, maternal RSVpreF vaccine/infant nirsevimab at 3 months, or infant nirsevimab alone at birth. To ascertain safety, infant tolerability, and the magnitude and durability of RSV-A and B neutralizing antibodies (nAbs), pairs were followed for 12 months.”
  • MedPage Today adds,
    • “Older U.S. adults who received the recombinant shingles vaccine had a lower incidence rate of dementia than their peers.
    • “Receiving the recombinant zoster vaccine also was linked to reduced risks of Alzheimer’s disease and vascular dementia.
    • “The analysis assessed dementia risk with the current two-dose shingles shot in the U.S., unlike other research.”
  • and
    • “Over 6 years, about 30% of people with pure autonomic failure converted to Parkinson’s, dementia with Lewy bodies, or multiple system atrophy.
    • “The incidence rate for general conversion, 5.1 per 100 person-years, far exceeded rates in the general population.
    • “The findings were based on a meta-analysis of nine studies that included 900 people with confirmed pure autonomic failure.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Tracking microbes is challenging, particularly when there are coexisting strains of the same species within metagenomic data. However, overcoming that challenge is important for inferring transmission of both pathogenic and commensal microbes.
    • “A new tool, called TRAnsmision Clustering of Strains (TRACS), distinguishes between closely related bacterial strains. The “highly accurate algorithm” can be used for “estimating genetic distances between strains at the level of individual single nucleotide polymorphisms, which is robust to intra-species diversity within the host.”
    • “Researchers used the TRACS tool to map the transmission of SARS-CoV-2, Streptococcus pneumoniae, and Plasmodium falciparum (the causative agent of malaria) across different populations. The tool may play an important role in infection prevention, outbreak response, and the development of treatments designed to help the human microbiome fight infection. They note that this tool can be used across microbial kingdoms to uncover strain dynamics.”
  • STAT News points out,
    • “A closely watched therapy developed by Johnson & Johnson failed to show a statistically meaningful improvement for patients with inflammatory bowel disease. But the company plans to advance the drug into late-stage testing, focusing on a growing subgroup of patients. 
    • “On Tuesday, trial investigators presented the results of Johnson & Johnson’s DUET study, testing how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. It’s a follow-up to a 2022 clinical trial that showed a significant benefit to patients, nearly doubling the rates of disease remission and spurring several companies to start developing combination approaches for IBD. 
    • “Johnson & Johnson tested its combined therapy, dubbed JNJ-4804, in two Phase 2b clinical trials hitting both major forms of inflammatory bowel disease — ulcerative colitis and Crohn’s disease. In each trial, the combination therapy performed better than the individual drugs, but did not meet the primary endpoint of clinical remission. 
    • “Though the results didn’t meet the mark statistically, Esi Lamousé-Smith, the company’s vice president of gastroenterology, said they were clinically meaningful. Data showed the drug was particularly effective in participants who had previously tried at least two medications, she added.”
  • BioPharma Dive notes,
    • “Cytokinetics said Tuesday that its drug Myqorzo succeeded in a Phase 3 trial in people with a progressive heart condition, opening up a sizable market opportunity and separating the treatment from a rival therapy marketed by Bristol Myers Squibb.
    • “According to Cytokinetics, Myqorzo met the dual main goals of a study in people with the “non-obstructive” form of hypertrophic cardiomyopathy, or HCM. When compared to a placebo, people receiving Myqorzo had a statistically significant improvement in peak oxygen consumption as well as scores on an assessment of heart health after 36 weeks. The drug also hit on key secondary measures, among them a commonly used evaluation of heart symptoms.
    • “Cytokinetics said no new safety signals were identified in the trial and that the percentage of patients completing treatment was similar between those getting Myqorzo or a placebo. Drops of over 50% in left ventricular “ejection fraction”— or the amount of blood pumped into the arteries, a known risk of drugs like Myqorzo — occurred in 27 treatment recipients, versus one in the placebo group. That side effect was associated with two cases of heart failure and led 3% of participants to interrupt treatment.”

From the U.S. healthcare business front,

  • The New York Times lets us know “there’s a right and wrong way to use urgent care.”
    • “We asked experts when you should use one, and when you’re better off visiting an ER or primary care doctor instead.”
  • Beckers Hospital Review tells us,
    • “Irving, Texas-based Christus Health took over operations May 1 at Mount Pleasant, Texas-based Titus Regional Medical Center, and renamed it Christus Health – Mount Pleasant Hospital, according to a May 1 release shared with Becker’s. 
    • “Christus Health was selected as the strategic partner for Titus Regional in early February after the board of managers for the 174-bed hospital voted to move forward with the transaction. 
    • “The acquisition is part of Christus Health’s broader expansion in the area. The system opened the Christus Health Mount Pleasant Emergency Care Center Feb. 9, a $33 million, 36,000-square-foot facility that also houses a multispecialty clinic, which opened April 13, and houses cardiology, gastroenterology, primary care, pulmonology, urology and more services.”
  • and
    • “As retailers, payers and drugmakers expand access to GLP-1 therapies — with companies like Amazon and Walmart launching weight management programs — the drug class is reshaping both care delivery and pharmaceutical investment strategies.
    • “That demand is influencing drug development, with obesity treatments overtaking oncology as the largest contributor to late-stage pipeline value for the first time in 16 years, according to a May 4 report from Deloitte.”
  • Fierce Pharm informs us,
    • “With a better-than-expected first quarter in the books, Pfizer—continuing to grapple with the post-pandemic overhang from its COVID-19 franchise—is sticking with the sales forecast it set earlier this year, raising questions from at least one analyst about whether it could have lifted its outlook.
    • “Buoyed by notable sales beats from blood thinner Eliquis, pneumococcal vaccine Prevnar and breast cancer medicine Ibrance, among others, Pfizer’s overall revenue in the first quarter grew 2% year over year on an operational basis to $14.5 billion. When excluding sales of its COVID-19 products Comirnaty and Paxlovid, the growth rate (PDF) was 7% for the period on an operational basis, the company said Tuesday.
    • “Pfizer’s “strong” performance across the board helped the company deliver first-quarter revenue about $641 million above consensus forecasts, according to a May 5 note from analysts at Citi. Pfizer is also demonstrating that its commercial portfolio can flourish beyond the historically mammoth sales of its COVID-19 vaccine and antiviral, the Citi team said, noting that the company’s crop of recent launches and acquired products—including Padcev, Nurtec and Lorbrena—grew 22% operationally for the quarter.”
  • Fierce Healthcare points out,
    • “CVS announced Tuesday it will expand its use of lower-cost biosimilars and transition to interchangeable alternatives for select brands, including Johnson & Johnson’s psoriasis drug Stelara.
    • “The change comes as CVS Caremark works to increase adoption of U.S. Food and Drug Administration approved biosimilars for its most common formularies. The update aligns with the company’s broader formulary strategy, emphasizing affordability, access and value.
    • “The changes will be effective July 1, the company said in the announcement. 
    • “Our formulary plays a critical role in addressing rising drug costs without compromising clinical quality,” said Joshua Fredell, CVS Health senior vice president, in a statement. “Expanding adoption of FDA-approved biosimilars allows us to deliver significant savings for clients while supporting broader, more affordable access to proven therapies.”
  • BioPharma Dive reports,
    • “Shares of Vertex Pharmaceuticals were little changed late Monday after the Boston-based biotechnology company reported its latest round of earnings.
    • “Vertex, which has ballooned to a roughly $110 billion value thanks to the market success of its cystic fibrosis medicines, recorded $3 billion in revenue across the first three months of the year. That total was just shy of Wall Street estimates, according to Evercore ISI analyst Cory Kasimov.
    • “The lion’s share of revenue again came from Trikafta, a three-in-one oral therapy that was approved in 2019 and has the potential to work in approximately 90% of cystic fibrosis patients. It generated $2.35 billion in the quarter, down 7% from the same period a year prior. Meanwhile, revenue from a successor drug called Alyftrek grew eightfold, to $424 million, which Kasimov argued “may potentially signal a healthy switch rate.”
  • MedTech Dive relates,
    • “Olympus is partnering with EndoRobotics to distribute the South Korea-based medical device manufacturer’s endoscopic robotic devices for gastroenterology.
    • “Olympus will exclusively distribute the technologies globally, beginning in the U.S., as part of its EndoTherapy portfolio, the Tokyo-based company said Monday in the announcement.
    • “The deal comes less than a year after Olympus entered into an agreement with investment firm Revival Healthcare Capital to found a company called Swan EndoSurgical for the purpose of co-developing a robotic platform for gastrointestinal treatment.”

Thursday report

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

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

From Washington, DC,

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

From the Food and Drug Adminstration front,

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

From the public health and medical / Rx research front,

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

From the healthcare business and artificial intelligence front,

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

Midweek update

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

From Washington, DC

  • Roll Call reports,
    • “The House took a major step toward providing funding for immigration enforcement agencies by adopting a Senate-backed budget resolution Wednesday evening.
    • “Now that both chambers have adopted the budget blueprint, lawmakers can move forward with a filibuster-proof reconciliation bill to provide around $70 billion in immigration enforcement funding. That money is designed to sustain the Immigration and Customs Enforcement and Customs and Border Protection agencies for the remainder of President Donald Trump’s term.
    • “The vote on the GOP-written resolution was 215-211, falling strictly along party lines. Rep. Kevin Kiley of California, a Republican-turned-independent from a swing district, voted “present.”
  • The Government Accountability Office released a report today finding
    • he Federal Employees Health Benefits program is the largest employer-sponsored health insurance program in the United States. The Office of Personnel Management is responsible for managing fraud risks in the program.
    • But OPM’s process for verifying whether health care providers were eligible to provide care under the program isn’t always working. For example, our data analyses identified claims from providers who were deceased or excluded from other federal programs for certain violations.
    • Our [fifteen] recommendations would improve OPM’s process for verifying health care provider eligibility and reduce risks to the program.
  • Fedweek relates,
    • In a memo issued on April 28, 2026, Office of Personnel Management (OPM) Director Scott Kupor advised federal agencies to exclude all employees in Schedule C and Schedule G General Schedule (GS) positions from the performance appraisal requirements under Subchapter I of Chapter 43 of Title 5, including requirements for performance standards, progress reviews, and annual ratings of record.
    • “This directive simplifies personnel management for these excepted-service political appointments, which are now treated as “at-will” roles where retention and removal do not hinge on formal performance ratings. 
    • “The memo clarifies that these employees operate outside the structured appraisal frameworks that apply to most competitive-service GS employees. They are excluded due to the confidential, policy-determining, policy-making, or policy-advocating nature of their positions.
    • “This latest memo is not a surprise, as it is a step in implementing [Schedule F] policies that have already been formulated.”
  • The Hill tells us,
    • “The Trump administration is no longer allowing federal funds to be used for purchasing or distributing test strips that can determine if street drugs have been mixed or cut with fentanyl or other contaminants, a reversal that comes amid the administration’s broader opposition to harm reduction practices. 
    • “In an open letter to federal grantees, the Substance Abuse and Mental Health Services Administration said it was ending the practice, which it has championed since 2021, because the strips are “intended for use by people using drugs.” 
    • “However, the notice emphasized that federal funds can still be used for test strips to be used by public health officials, law enforcement, medical workers and others in professional settings.  
    • “Test strips cost about $1 each and can detect drugs like fentanyl or animal tranquilizers like xylazine and medetomidine. Many states have legalized test strips in an effort to slow the number of overdose deaths.” 
  • The American Hospital Association News informs us,
    • “The Agency for Healthcare Research and Quality has issued a request for nominations for candidates to serve on the U.S. Preventive Services Task Force. While all nominees will be considered, AHRQ said it encourages nominations of physician specialists in anesthesiology/pain management, cardiology, endocrinology, family medicine, gastroenterology, hematology/oncology, internal medicine, obstetrics and gynecology, pediatrics, preventive medicine and radiology, as well as experts in health economics. The agency said it will also consider applications from physicians in specialties including but not limited to surgery, laboratory medicine/molecular pathology and clinical genetics. AHRQ is also seeking wide geographic representation and experience in diverse settings, including individuals with expertise in rural medicine. Nominations must be received by AHRQ electronically by May 23 to be considered for appointment beginning in June.”
  • Bloomberg Law adds,
    • “The Trump administration is appealing a federal district court order that temporarily blocked US Health Secretary Robert F. Kennedy Jr.’s changes to the nation’s childhood vaccine schedule.
    • “The US Department of Justice filed a notice Wednesday to appeal an order issued March 16 by Judge Brian Murphy of the US District Court for the District of Massachusetts that halted decisions made by a vaccine advisory panel earlier this year to drastically reduce the number of recommended shots for kids. 
    • “The appeal to the US Court of Appeals for the First Circuit challenges the judge’s decision to temporarily block Kennedy’s appointments of 13 members to the panel, the Advisory Committee on Immunization Practices, which helps determine which vaccines are covered by insurance and provided for free for some children.
    • “The committee was scheduled to convene on March 18-19 at the US Centers for Disease Control and Prevention headquarters, but the court ruled it can’t meet and the meeting was subsequently postponed.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration on Wednesday released the results of a major study examining the safety of infant formula sold in the U.S., finding that most products contained low or undetectable levels of contaminants including heavy metals.
    • “The findings come amid “Operation Stork Speed,” the Trump administration’s sweeping review of U.S. infant formula ingredients. Federal officials said the results reinforce that the nation’s infant formula supply is safe, while adding that the FDA will continue additional testing as part of its continuing monitoring and oversight efforts.
    • “We tested more infant formula than ever before, and the results are clear: most products meet a high safety standard—but even small exposures matter for newborns,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement.” * * *
    • “Although the results didn’t break down findings by specific companies, leading manufacturers welcomed the report.”
  • MedTech Dive relates,
    • “Medtronic received Food and Drug Administration approval for its next-generation mitral valve and has launched the device in the U.S., the company said Wednesday.
    • “Called Mosaic Neo, the bioprosthetic valve is designed to be implanted through sternotomy, which requires separating the breastbone to reach the heart, or through minimally invasive surgery.
    • “In addition, the first concomitant procedure was performed where the Mosaic valve was implanted alongside Medtronic’s Penditure left atrial appendage exclusion device, the company said. The Penditure clip is designed to close the left atrial appendage to help prevent clots from entering the bloodstream.”
  • Cardiovascular News informs us,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about a potential safety issue with certain Relay Pro Thoracic Stent Grafts from Terumo Aortic. 
    • “These devices are used by interventional cardiologists and vascular surgeons to repair damaged or weakened sections of a patient’s thoracic aorta. However, Terumo Aortic has received multiple reports of the stent being unable to unclasp from the delivery system. When this happens, it can lead to significant risks, including death. As of April 23, in fact, three deaths have been directly linked to this issue.
    • “Difficulties in releasing the stent graft may result in delay of procedure, stent graft displacement, and an inability to release the stent graft,” according to the FDA’s warning. “This may require conversion to open surgical repair to release the clasp and can result in patient death. Please be advised that this failure mode can occur without prior warning and no device-based bailout method has been identified for this specific scenario.”
  • and
    • “Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for Ultreon 3.0, its next-generation coronary imaging platform.
    • “Ultreon 3.0, an update of the company’s Ultreon 2.0 technology, uses advanced artificial intelligence (AI) algorithms to capture and evaluate optical coherence tomography (OCT) images, delivering real-time guidance during percutaneous coronary intervention (PCI) procedures. OCT is a critical modality for the diagnosis, treatment and management of coronary disease. This platform was built to give clinicians detailed OCT images from inside the blood vessels. It then uses those images to assess the blockage being treated and make recommendations to the PCI operator on the selection and placement any stents.
    • “Ultreon 3.0 represents a pivotal step forward in how we treat and ultimately care for our patients,” Evan Shlofmitz, DO, director of interventional cardiology at St. Francis Hospital and Health Center in Roslyn, New York, said in a statement. “This next-generation platform, combining imaging and AI, doesn’t just improve upon existing technology—it leapfrogs it. By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Marriage is linked to a lower risk of developing cancer, recent research found.
    • “A study of more than 4 million cancer cases in the U.S. found that cancer rates were about 68% higher among men who have never married compared with those who have. For never-married women, the relationship was even more pronounced, with cancer rates roughly 83% higher, according to research published recently in the journal Cancer Research Communications.
    • “Married people tend to have greater economic stability and better support systems, and they are more likely to stick with treatment, said Paulo Pinheiro, professor of cancer epidemiology at the University of Miami School of Medicine’s Sylvester Comprehensive Cancer Center and co-author of the findings. 
    • “Previous studies have found that married people who have cancer tend to get diagnosed earlier and have better survival rates. 
    • ‘The recent study looked at data collected between 2015 and 2022 encompassing more than 100 million people aged 30 or older from across 12 states. About 20% were unmarried.” 
  • Healio informs us,
    • “A large measles outbreak in South Carolina has ended after nearly 1,000 cases.
    • “More than 8,000 measles vaccinations were administered during the outbreak, which began in October.”
  • Health Day relates,
    • “Mail-in colon cancer kits can extend easy, affordable cancer screening to low-income folks, study shows
    • “People preferred returning test kits that look for cancer-related DNA
    • “That might be because the kits had more comprehensive support from their manufacturer, researchers said.”
  • Medpage Today tells us,
    • “Over 15 years, a moderately protein-restricted diet was tied to a lower risk of starting dialysis in patients with stages 3 or 4 chronic kidney disease.
    • “Associations with a 50% eGFR decline and all-cause mortality approached, but did not achieve, statistical significance.
    • “Findings support guideline-based care while emphasizing practicality, the researchers noted.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (Takeda Pharmaceutical Co., Ltd.) for narcolepsy type 1.
    • “Current treatments for narcolepsy do not address the underlying cause of the condition, and many patients report incomplete relief from narcolepsy symptoms despite multiple medications,” said ICER’s Senior Vice President of Research, Foluso Agboola, MBBS, MPH.  “ICER’s analyses found that oveporexton, the first medication for narcolepsy type 1 that directly addresses the underlying cause of the condition, is effective in promoting wakefulness, improving quality of life, and appears to offer better health benefits than current options. Pricing choices that balance innovation rewards while addressing long-term value and patient access will be important topics at the public meeting.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on May 14, 2026. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.” * * *
    • “Oveporexton has not yet been approved by the FDA for narcolepsy type 1. The manufacturers have not yet announced a US price for the therapy if approved. ICER calculated a health benefit price benchmark (HBPB) between $50,400 and $59,400 per year.”

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

  • The Wall Street Journal reports,
    • “Humana reported lower first-quarter profit, with shares down 7.4% in premarket trading, due to lower 2026 Medicare Advantage Star Ratings.
    • “The company reiterated its full-year adjusted-earnings guidance but cut its nonadjusted earnings outlook to at least $8.36 a share.
    • “Humana incurred charges for a multiyear transformation program and faced higher medical costs, particularly from older people using services.”
  • Beckers Payer Issues relates
    • “Blue Cross NC recorded a net loss of $497.3 million in 2025, according to regulatory filings.
    • “The insurer posted a net income of $68.5 million in 2024 and $133 million in 2023.” * * *
    • ‘The company reported total assets of $7.2 billion as of year-end 2025, with capital and surplus of $3 billion. Medicaid was the company’s largest line of business by direct premiums written at $3.5 billion, followed by Medicare at $2.2 billion, the Federal Employees Health Benefits program at $1.8 billion, Medicare supplement at $397.4 million, and dental at $101.3 million.”
  • and
    • “BlueCross BlueShield of Tennessee recorded a net income of $168.4 million in 2025, a 62% decline from $446.8 million in 2024, according to regulatory filings.
    • “In its 2025 impact report, the insurer said 89 cents of every premium dollar collected last year was used to pay member claims, and medical and pharmacy claims payments have increased 25% over the past five years.
    • “The company reported total assets of $6.7 billion as of year-end 2025, with capital and surplus of $5.4 billion. Medicare was the company’s largest line of business by direct premiums written at $2.5 billion, followed by the Federal Employees Health Benefits program at $1.1 billion, dental at $172.6 million, Medicare supplement at $153.5 million, and vision at $37.4 million.”
  • Fierce Healthcare tells us,
    • “Teladoc Health reported a 2% decline in revenue in the first quarter, but the telehealth giant touted “meaningful progress” in scaling insurance coverage for its BetterHelp mental health business as a catalyst for future growth.
    • “The virtual care company reported Q1 revenue of $613.8 million compared to $629 million a year ago. Access fees revenue decreased 8% to $484.7 million.
    • “U.S. revenue dropped 6% to $491.5 million while revenue from international markets rose 17% to $122.3 million. The company’s integrated care segment revenue inched up 2% to $395.4 million and its BetterHelp segment saw revenue fall 9% to $218.4 million. Aside from access fee revenue, Teladoc Health reported “other revenue” jumped 25% to $129.2 million during the quarter.
    • “The company reported adjusted EBITDA of $58.2 million, essentially flat year-over-year, and the company narrowed its losses from a loss of $93 million in Q1 2025 to a net loss of $63.8 million, or $0.36 per share, in the most recent quarter.”
  • Beckers Hospital Review discusses “three barriers to GLP-1 adherence — and how systems are overcoming them.”
  • Health CIO informs us,
    • “Nearly 80% of provider-payer partnerships recognized in KLAS Research’s 2026 Points of Light report centered on value-based care workflows. That figure stood at 48% the year before. The shift signals that interoperability has graduated from differentiator to baseline expectation. Success in provider-payer collaboration will now hinge on whether shared data drives measurable financial and clinical outcomes.
    • “The report, released in April 2026 and produced through KLAS’s K2 Collaborative, profiles 24 award-winning partnerships. KLAS validated each through structured interviews conducted between September 2025 and February 2026. Of those 24 collaborations, 23 involved interoperability or clinical data exchange in some form. Federal mandates such as CMS-0057-F are accelerating adoption of FHIR-based APIs and HL7 Da Vinci implementation guides. As a result, payers and providers are moving toward standardized exchange that supports patient access, payer-to-payer transfers, and electronic prior authorization.”
  • BioPharma Dive points out,
    • “Teva Pharmaceutical is wagering up to $900 million on a biotechnology company built around a potential treatment for Tourette syndrome.
    • “Through an acquisition announced Wednesday, Teva will take control of privately held Emalex Biosciences and its drug ecopipam, which is in late-stage clinical testing. Ecopipam is meant to inhibit “D1,” a kind of dopamine-regulating protein that research suggests may play a role in the involuntary movements, or tics, associated with Tourette’s. The antipsychotics often used to treat this disorder target a different but related protein, D2.
    • “The companies expect their deal to close sometime between July and the end of September. Terms hold that Teva will pay $700 million up front and possibly as much as $200 million more if ecopipam hits certain commercial goals. Emalex shareholders will be eligible to receive sales-based royalties as well.”

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.”

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.”

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.”