Thursday report

Obesity

Thursday report

David Ermer–CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

A commenter, Patrick Morselli, accurately observed in response to the OPM Director’s blog post that “Simplicity has a high cost in most organizations. Feels like the hardest work is undoing complexity other smart people left behind.”

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Republicans broke with President Trump over his administration’s plan to create a $1.8 billion settlement fund to pay people who claim political persecution, with widespread opposition forcing party leaders Thursday to abandon votes on immigration-enforcement funding and send lawmakers home early for their Memorial Day break.
    • “The “anti-weaponization” fund is a Trump priority, after he alleged for years that his supporters, including those prosecuted over the Jan. 6, 2021, attack at the Capitol, had been targeted unfairly by the Biden administration. But its creation has run into blowback in the Senate, and the immigration-enforcement bill gave senators leverage to dig in their heels.
    • “I don’t like the fund at all,” said Sen. John Curtis (R., Utah), who added he didn’t think any guardrails could fix it. Sen. Thom Tillis (R., N.C.), a frequent target of Trump criticism who is retiring, called it a “payout pot for punks.”
    • “With no resolution in sight, Senate Majority Leader John Thune (R., S.D.) sent senators home for their weeklong Memorial Day recess, putting the Republican-led Congress on course to miss Trump’s deadline to have the Immigration and Customs Enforcement and Border Patrol measure on his desk by June 1.”
  • Healthcare Dive relates,
    • “Lawmakers are mulling reform of how Medicare pays physicians, concerned that insufficient reimbursement in the federal insurance program is incentivizing consolidation and increasing healthcare costs.
    • “Physician pay has declined over the past two decades when accounting for inflation, spurring independent providers to be acquired by hospital systems rather than go it alone, provider witnesses told representatives during a House Energy and Commerce subcommittee hearing Wednesday. And representatives agreed that’s a concern.
    • “Making sure that independent physician practices stay open […] is one of the most critical ways we can ensure competition and drive down costs,” said Rep. Kim Schrier, D-Wash.”
  • The American Hospital Association adds,
    • “Rep. Randy Feenstra, R-Iowa, introduced the Rural Maternity Options for Medical Support Act on May 19. The bill would guarantee that beds used solely for labor and delivery are not counted toward the 25-bed limit for critical access hospitals. The bill is co-sponsored by Reps. Darin LaHood, R-Ill., Jill Tokuda, D-Hawaii, and Kim Schrier, D-Wash. 
    • “New and expecting moms deserve access to high-quality labor and delivery services,” said Lisa Kidder Hrobsky, AHA senior vice president for advocacy and political affairs. “The Rural Maternity Options for Medical Support Act of 2026 strengthens access to maternal health services for mothers in rural areas by ensuring that higher volume critical access hospitals have labor and delivery beds available, even if their other patient beds are full. The AHA appreciates Rep. Feenstra’s leadership to support critical access hospitals and families across the nation.” 
  • and
    • “The House Education and Workforce Committee May 21 unanimously passed the Transparency in Billing Act (H.R. 8684). The bill would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and it would impose civil monetary penalties on hospitals that violate the requirement. 
    • The AHA has previously opposed this policy, saying that hospitals are already transparent about the location of care delivery on their bills and that it would create a significant administrative burden to providers and the health care industry at large.” 
  • Fierce Healthcare tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. removed two key leaders of the U.S. Preventive Services Task Force (USPSTF), a key advisory panel that offers guidance on preventive services, according to media reports.
    • ‘Vice chairs John Wong, M.D. and Esa Davis, M.D. were dismissed from the task force in letters sent to them by Kennedy on May 11, The New York Times reported on Wednesday, citing copies of the letters obtained by reporters. STAT, CNN, Politico and The Hill also reported the terminations, citing the letters.” * * *
    • “The terminations leave the panel with just eight sitting members. Five other members saw their terms expire at the start of this year, and Kennedy did not replace them, and the previous chair, Michael Silverstein, departed on his own, STAT reported.”
  • Federal Network News informs us,
    • “Shane Stevens, the top official for the Office of Personnel Management’s healthcare and insurance arm, is stepping down from his role, Federal News Network has learned.
    • “Stevens, a political appointee, has been serving as associate director of healthcare and insurance at OPM since last summer. He announced in an email Thursday afternoon that he is voluntarily resigning, effective immediately.”
  • Best wishes, Mr. Stevens. Thanks for your service.
  • Tammy Flanagan, writing in Govexec, lets us know “what federal employees get wrong about divorce and retirement.”
    • “Errors involving survivor benefits, health coverage and court orders can create financial problems years after a marriage ends.”
  • FedWeek explains “Insuring Children at College and Federal Benefits Considerations (with a Checklist).”

From the Food and Drug Administration front,

  • Radiology Business reports,
    • “Medtronic is recalling more than 18,000 surgical devices due to a risk of contamination. The recall includes certain lots of the company’s Gundry and DLP retrograde cannulae, which are cardiopulmonary bypass vascular catheters used to perform open heart surgeries.
    • “This recall was put in place due to the potential of a sterile barrier breach. Only certain lots of these devices are included in the recall.
    • ‘The U.S. Food and Drug Administration (FDA) has ruled this as a Class II recall. This means the agency believes these devices could cause “temporary or medically reversible adverse health consequences.”
  • STAT News relates,
    • “Wearable maker Whoop has not resolved a dispute with the Food and Drug Administration over a blood pressure feature the company launched last year, according to a top health executive at the company. 
    • “FDA warned Whoop last July over the feature that gives users a daily estimate of their systolic and diastolic blood pressure, saying that it’s a medical device that requires agency review. Whoop argues that the feature is exempt from FDA review because it is intended for wellness purposes.” * * *
    • “The dispute between FDA and Whoop turned up the heat in a simmering debate about how the agency ought to oversee low-risk products. Proponents of deregulation argue that the time and expense required for FDA authorization impede innovation and that FDA review is unnecessary to ensure the safety of many products that potentially benefit consumers.”

From the judicial front,

  • Federal News Network reports,
    • “Some federal employees may now have an easier time qualifying for disability retirement benefits, following a recent precedential decision from the U.S. Court of Appeals for the Federal Circuit.”
    • “In April, the court ruled that federal employees’ disability retirement applications cannot be denied solely based on a lack of “objective” medical evidence. The ruling applies in cases where federal employees have already been removed from their jobs due to a “medical inability to perform.”
    • “Objective documentation, like lab tests or prescription lists, can support an argument but cannot be the sole basis for denying claims, the court said. “Subjective” medical evidence, like a diagnosis based on self-described symptoms, must also be considered. If employees’ disability retirement claims rely on subjective evidence, they won’t automatically be denied benefits.
    • “The decision last month overturned a 2024 ruling from the Merit Systems Protection Board, which had upheld the Office of Personnel Management’s denial of a disability retirement application from a former OPM employee in 2016.”
  • The New York Times relates,
    • “The Justice Department announced charges on Thursday against 15 people for attempting to defraud Minnesota Medicaid and other social service programs in the state of more than $90 million. 
    • “Top officials, including Robert F. Kennedy Jr., the health and human services secretary, and Mehmet Oz, head of the Centers for Medicare and Medicaid Services, appeared in Minneapolis to announce the charges. “The fraud here in Minnesota is shocking,” said Colin McDonald, an assistant attorney general overseeing the administration’s crackdown on fraud.
    • “Among the defendants are an owner and an employee of autism clinics, who are charged with submitting $46.6 million in fraudulent claims to Medicaid, the public health plan that covers low-income people. Additional defendants were charged with filing bogus claims to Medicaid for other services, including those that assist disabled people with obtaining housing and living independently.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The world’s most popular weight-loss and diabetes drugs are linked to a powerful new possible benefit: better outcomes for cancer patients. 
    • “A suite of four new studies suggest that people taking so-called GLP-1 drugs like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro saw reductions in tumor progression, lower overall chance of death and less risk of developing breast cancer.
    • “It’s really provocative that they showed, in several cancers, that people who took these drugs seem to have a lower risk of their cancer returning,” said Dr. Jennifer Ligibel, a breast oncologist at the Dana-Farber Cancer Institute who wasn’t involved in any of the studies.
    • “One study from researchers at the Cleveland Clinic Cancer Institute tracked more than 10,000 patients with early-stage cancers who started GLP-1 drugs after diagnosis and compared their disease progression to those on a different diabetes medication. Those on GLP-1s were less likely to see their cancer spread.
    • “In lung cancer patients, the rate of progression to advanced disease was cut roughly in half—10% in GLP-1 users versus 22% in the comparison group. Breast cancer patients showed a similar pattern, with progression rates of 10% versus 20%. Colorectal and liver cancers also showed statistically significant reductions.”
  • and
    • “An investigational drug developed by Eli Lilly LLY  delivered clinically meaningful weight loss in a trial, the company said as it looks to expand its obesity treatment portfolio amid soaring demand.
    • “Lilly said Thursday that retatrutide, designed to be taken once a week, met the primary endpoint in a phase 3 clinical trial, as well as key secondary endpoints.
    • “According to Ania Jastreboff, a Yale School of Medicine professor and lead investigator for the trial, every dose of retatrutide assessed resulted in clinically meaningful weight reduction for nearly all participants. On average, those with severe obesity on the highest dose lost 30% of their body weight over two years, Jastreboff added.
    • “The trial evaluated the therapy’s efficacy and safety on adults who are overweight and had other medical conditions such as type 2 diabetes, chronic pain and cardiovascular issues.
    • “More results will be shared later this year, Lilly added.”
  • Healio adds,
    • “Studies show that GLP-1 receptor agonists have significant potential for treating glaucoma, diabetic retinopathy and other eye diseases, but important nuances remain to be investigated, according to a review published in BMC Ophthalmology.
    • “Although GLP-1 RAs have revolutionized metabolic disease management, their potential therapeutic role in ocular diseases — particularly those driven by shared metabolic and inflammatory pathways — remains underexplored,” Yu Luo, of Beijing University of Chinese Medicine, and colleagues wrote. “Their multifaceted neuroprotective properties and anti-inflammatory mechanisms present a distinctive therapeutic opportunity for ophthalmic pathologies, potentially offering direct ocular benefits beyond systemic metabolic control.”
  • and
    • “Adults with obesity achieved greater long-term weight loss if they partook in a nutrition plan designed for rapid weight loss compared with one designed for gradual weight loss, according to trial data.
    • “Line Kristin Johnson, RD, PhD, senior researcher at Vestfold Hospital Trust in Norway, said there has been debate among researchers regarding whether rapid weight loss leads to worse long-term outcomes for people with obesity. In findings from a randomized pragmatic trial presented at the European Congress on Obesity, Johnson and colleagues found implementing a calorie-restricted eating pattern for rapid weight loss can induce a larger decrease in body weight at 1 year than a gradual weight-loss eating pattern.”
  • Endocrinology Advisor points out,
    • “Life-course body size progression, particularly transitioning from a thinner childhood body size to adult obesity, significantly increases risks for stroke, coronary artery disease, and heart failure.”
  • Healio also notes,
    • “Only a third of cancer survivors receive advice on weight control and improving their diet from health care professionals, and less than half are informed about the benefits of physical activity.
    • “Individuals who do receive advice on losing weight, salt and fat intake, and exercise are three to eight times more likely to engage in healthy behaviors than those who did not.
    • “We need more effort to deliver lifestyle behaviors to patients,” Chao Cao, PhD, MPH, instructor in the department of medical oncology at Dana-Farber Cancer Institute, told Healio.”
  • Fierce Pharma tells us,
    • “Phase 3 data for Merck & Co. and Kelun-Biotech’s antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) suggest the race is heating up to establish a new standard of care in first-line non-small cell lung cancer.
    • “According to an abstract released ahead of the ASCO 2026 annual meeting, combining the TROP2-directed ADC with Keytruda slashed the risk of disease progression or death by a major 65% compared with Keytruda alone in treatment-naïve, PD-L1-positive NSCLC. The p-value is below 0.0001, suggesting high statistical significance.
    • “Key overall survival results, which will underpin regulatory considerations in first-line NSCLC, were not mature at the Sept. 29, 2025, data cutoff, but a strong trend with a preliminary 45% improvement in favor of the combo arm was observed.” 
  • Per MedPage Today,
    • “Undetected attention deficit-hyperactivity disorder (ADHD) was not uncommon among adults hospitalized after traffic accidents, according to a cross-sectional study from the Dominican Republic.
    • ‘Among 95 adults admitted for traffic-related injuries without a prior diagnosis, more than a third (34.7%) screened positive on the Adult ADHD Self-Report Scale, reported Amanda Abreu, MD, of the Universidad Iberoamericana in Santo Domingo, Dominican Republic.
    • “High-risk driving behaviors — including violations, mistakes, and slips — were more common among adults who screened positive (66.6% vs 30.6%, P=0.0016), she reported at the American Psychiatric Association annual meeting.
    • “We’re not saying that ADHD alone caused the accidents, nor are they unsafe drivers, but these findings suggest that this is a really vulnerable population we should look into, and we should help protect,” Abreu said.”
  • and
    • “Low-risk pancreatic cystic lesions were found to be associated with a long-term risk of pancreatic cancer in a retrospective cohort study.
    • “The incidence rate of pancreatic cancer among patients with pancreatic cystic lesions was higher than that of the general population (1.89 vs 0.14 per 1,000 person-years).
    • ‘Over a quarter of patients were diagnosed with pancreatic cancer more than 5 years after detection of lesions, suggesting longer-term follow-up is needed to avoid missed diagnoses.”
  • Per the Wall Street Journal,
    • “New French research links natural food color additives to increased risks of Type 2 diabetes and cancer, similar to synthetic dyes.
    • “Beta-carotene, curcumin and anthocyanins used as color additives were linked to a higher risk of Type 2 diabetes. Beta-carotene used as a food coloring was also linked to breast cancer.
    • “The findings challenge the Trump administration’s push for natural dyes and food companies’ shift away from artificial colors.”
  • Per BioPharma Dive,
    • “BioMarin is looking to expand the use of its top-selling medicine, Voxzogo, with positive study results released Wednesday.
    • I’n 2021, Voxzogo became the first drug approved to improve growth in children with achondroplasia, the most common form of dwarfism. The new results pertain to a related condition called hypochondroplasia that generally presents in less severe ways and might not be noticed until later in a child’s life.
    • ‘In the Phase 3 trial, researchers found participants given Voxzogo were growing faster than those who received a placebo. After a year, the Voxzogo patients also had significant increases in standing height and arm span, a key finding that could help children function better in daily tasks and retain more independence.”

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

  • Managed Healthcare Executive reports,
    • ‘For the average person, healthcare costs rose 7.9% in 2026 to $8,460, which is the highest annual increase in more than a decade, according to the 2026 Milliman Medical Index
      (MMI). For a hypothetical family of four, healthcare costs reached $37,824, Milliman found. The Milliman Medical Index measures healthcare costs covered by a typical employer-sponsored health insurance plan.”
    • “The increase reflects structural forces that are not going away, Milliman Principal and Consulting Actuary Deana Bell said in a news release. “Outpatient costs have quadrupled for the MMI’s family of four since the MMI was first published in 2005, with much of the trend exacerbated by delivery system consolidation, specialty drug growth, and site-of-care shifts.”
  • Beckers Hospital Review relates,
    • “The National Council of State Boards of Nursing found the District of Columbia has the most licensed nurses per capita, while Utah is the state with the fewest for the second year in a row.
    • “The organization created a course of nursing licensure statistics in the U.S. and its territories. The data was compiled using the NCSBN’s database and Nursys, an electronic information system where regulatory bodies enter licensure data. All of the council’s 58 members shared licensure data, which amounted to 6,903,665 registered and practical nurses — up from 6,870,362 last year.
    • ‘According to the data, Wyoming and Vermont had the fewest licensed nurses in their states overall, at 9,620 and 13,528, respectively. Meanwhile, California and New York had the most licensed nurses at 708,141 and 610,207, respectively.” 
  • Healthcare Dive tells us,
    • “Nonprofit health system Providence is throwing in the towel on the majority of its health insurance businesses, citing the difficulty of running a regional health plan amid regulatory pressures and rising costs.
    • “Starting next year, Providence, which covers about 440,000 people in a handful of western states, will no longer offer Medicaid, Affordable Care Act or employer-sponsored plans, the Renton, Washington-based system announced on Wednesday.
    • ‘The decision comes as Providence attempts to shore up its financial footing and refocus on delivering care. Still, the company plans to maintain its Medicare Advantage operations through a partnership with a national carrier, according to the release.”
  • Modern Healthcare tells us,
    • “Sutter Health and Allina Health have moved a step closer to joining forces.
    • “Sacramento, California-based Sutter and Minneapolis-based Allina said Thursday they signed a definitive agreement to form a $26 billion combined system with 39 hospitals. The agreement follows a letter of intent announced in March. The proposal is on track to close by the end of the year pending customary regulatory approval, the organizations said in a news release.” 
  • BioPharma Dive informs us,
    • “Eli Lilly has snagged Engage Biologics, a biotechnology company that aims to deliver genetic medicines without viral payloads, in a deal worth up to $202 million.
    • “Lilly said Wednesday it has acquired the preclinical biotech in an all-cash deal, including an undisclosed upfront payment, with the possibility of future payouts based on research, development and commercialization milestones. The acquisition gives Lilly non-viral DNA delivery technology, dubbed the “Tethosome” platform.
    • “We believe that the combination of Engage’s platform with Lilly’s significant capabilities will meaningfully accelerate development of new genetic therapies,” Will Olsen, co-founder and CEO of Engage, said in a statement.”
  • Fierce Healthcare lets us know,
    • “Electronic medical record (EMR) company Canvas Medical launched Canvas Studio Thursday, a no-code interface that allows clinicians and other healthcare professionals to build custom EMR workflows.
    • “Canvas Medical CEO Adam Farren told Fierce Healthcare the company was “serving a market” for software developers to customize workflows for end users within its ONC-certified EHR platform. 
    • “What Studio does is replace the developer with an AI agent, so that the end user, the clinician or administrative staff user, can directly customize and extend Canvas themselves using the agent,” Farren said.”
  • and
    • “Employers are set to significantly increase their use of AI in health benefits, a new survey shows, even as they continue to face barriers to rolling out the tech.
    • “WTW polled 312 employers with about 4.6 million workers for the 2026 AI Use in Health and Benefits Survey, and found that 72% of those surveyed plan to embed AI into their benefits programs in the next two years. By comparison, only 20% said they are currently doing so.
    • “The employers cited several key areas where they see AI likely supporting benefits at work, such as improved communication, cited by 68%, and data insights and analytics, noted by 59%. In addition, 57% of those surveyed said AI would likely support greater personalization.
    • “Jeff Chandler, North America commercialization leader for Health & Benefits at WTW, said in a press release that these top priorities are all “areas where AI can materially improve how benefits teams make decisions and support employees.”

Friday report

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

From Washington, DC

  • Roll Call informs us,
    • “Republican leaders in Congress scored some victories this week in nominations and appropriations but struck out on easily advancing their partisan “reconciliation 2.0” proposal to fund immigration enforcement.
    • “The bill faces a hurdle in the form of the Senate Parliamentarian, who on Thursday evening advised that several provisions violate the Senate’s restrictive Byrd rule — and more could be coming. 
    • “This throws an obstacle in the way of the GOP’s efforts to provide some $72 billion in funding for immigration enforcement by President Donald Trump’s June 1 deadline, as Republicans will have to rewrite parts of the package to pass it with the filibuster-proof budget reconciliation process, requiring a simple-majority vote to pass, instead of the 60-vote threshold required for regular legislation.
    • “Republicans are expected to try to rewrite the legislation to remedy the violations or, if that’s not possible, remove the offending provisions ahead of a Homeland Security Committee markup of the title next week. 
    • “Senate Parliamentarian Elizabeth MacDonough was expected to hold a second “Byrd bath” Friday to hear arguments from Democratic and Republican Senate staff about the Judiciary Committee’s portion of the bill, including Secret Service money for security upgrades tied to Trump’s White House ballroom project.” 
  • Mercer Consulting reports,
    • “With the midterm congressional elections approaching and healthcare affordability top of mind for voters, lawmakers are actively considering new healthcare transparency reforms, including requirements for providers to show plainly what patients will have to pay and new billing standards for hospitals.
    • “Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy, R-LA, highlighted such price transparency legislation — Patients Deserve Price Tags Act (S 2355/HR 5582) — during a field hearing in Louisiana during last week’s congressional recess. Cassidy’s interest could signal that the legislation, which has may cosponsors from both parties, could soon see action at the Committee. 
    • “The bill would codify and expand current hospital price transparency rules that were established in the first Trump administration by extending requirements to clinical diagnostic laboratories, imaging centers, and ambulatory surgical centers. It would also make the prices that hospitals post clearer by requiring actual dollar-and-cents amounts, not estimates, as well as sharply increase financial penalties for hospitals and insurers that fail to disclose their negotiated rates. In addition, group health plans and insurers would have to give patients upfront, personalized cost estimates through an online self-service tool, as well as paper or phone options, before care is provided. The bill also ensures group health plans have access to claims data and prohibits third-party administrators from restricting that access.
    • “While several plan sponsor trade groups publicly support the legislation, they are working with lawmakers to make certain provisions more workable and better aligned with the PBM-focused transparency rules enacted in the Consolidated Appropriations Act, 2026 and proposed by the Department of Labor.”
  • AHIP lets us know “What They Are Saying: Broad Range of Experts Agree on a Root Cause of Healthcare Cost Crisis.”
    • “The evidence continues to underscore that making healthcare more affordable requires policymakers to address the root causes of high costs head-on through common-sense solutions like cracking down on anti-competitive hospital mergers and implementing site-neutral payment reforms.
    • “To learn more about how rising hospital costs are driving premiums higher and what policymakers can do to address it, visit AHIP.org/CostConnection.”
  • Fierce Healthcare relates,
    • “A bipartisan group of lawmakers in both chambers of Congress has reintroduced a bill aimed at barring companies from owning both a pharmacy benefit manager and retail pharmacies.
    • “The bill, called the Patients Before Monopolies (PBM) Act, would force conglomerates that include a PBM to divest pharmacies that they own. The legislation has existed in some form since 2024, and since its first introduction, Arkansas has implemented a similar legislation at the state level.
    • “Last month, Tennessee legislators also passed a bill that would prevent PBMs from owning pharmacies, which the governor is expected to sign into law.”
  • Mercer adds,
    • “Several developments in 2026 signal that the Trump administration is committed to improving behavioral health benefits for group health plan participants and beneficiaries — but the administration intends to put its own stamp on enforcement of the Mental Health Parity and Addiction Equity Act and propose new rules interpreting the landmark law.”
  • Per an HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $255 million to Vibrant Emotional Health (Vibrant) to administer the 988 Suicide & Crisis Lifeline. The 988 Lifeline is a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded network administrator. The 988 Lifeline has received more than 25 million contacts via call, text, chat, and ASL videophone since its launch.”
  • Modern Healthcare notes,
    • “The Centers for Medicare and Medicaid Service solicited the healthcare industry on ways it can identify and prevent fraud.
    • “The anti-fraud push drew cautious support, with providers and insurers seeking clear guardrails.
    • “Providers and insurers urged CMS to target high-risk services and avoid sweeping actions that would hamper care.” * * *
    • “New policies should focus on high-risk activities and not burden the ”vast majority of healthcare providers that are honorable in pursuing a mission to provide high-quality healthcare,” wrote the American Health Care Association/National Center for Assisted Living, which represents long-term care providers.
    • “The agency should also be careful not to add administrative burden since hospitals “already operate under extensive oversight requirements,” the American Hospital Association wrote.”
  • Beckers Payer Issues explains the federal crackdown on healthcare fraud, waste and abuse.
  • Newfront brings us up to date on the 2026 PCORI fee, which applies to FEHB and PSHB plan carriers.
    • “IRS Notice 2025-61 adjusts the Patient-Centered Outcomes Research Institute (PCORI) fee to $3.84 per covered individual for health plan years ending on or after October 1, 2025 and before October 1, 2026, including 2025 calendar plan years. This represents a 37-cent increase from last year’s $3.47 PCORI fee.
    • “Action Item: The annual PCORI fee must be reported and paid to the IRS by July 31, 2026, via the second quarter Form 720 (Rev. June 2026).”
  • HR Dive points out,
    • “The U.S. Equal Employment Opportunity Commission plans to end employee demographic data reporting, according to a proposal sent to the White House on Thursday.
    • “The agency wants to get rid of EEO-1, EEO-2, EEO-3, EEO-4 and EEO-5 reporting requirements. EEOC also wants to axe reporting requirements related to Title VII of the Civil Rights Act, the Americans with Disabilities Act, the Genetic Information Nondiscrimination Act and the Pregnant Workers Fairness Act.
    • “EEO-1 reporting has been a cornerstone of HR duties, required by firms with 100 or more employees and federal contractors with 50 or more employees that meet certain requirements. EEOC and analysts have used it to assess demographic data nationally, and — while the process is sometimes viewed as burdensome — employers have reportedly used the collected data for self-assessments regarding nondiscrimination and diversity.”
  • The Census Bureau notes,
    • “Since 2020, city centers of many major U.S. metro areas have had sluggish population gains, with some places even declining. But where growth did occur, it was mostly on the outer edges of these metro areas — with some exceptions.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With the ink barely dry on outgoing commissioner Marty Makary’s resignation, another top regulator may be heading for the exit at the FDA. 
    • “Tracy Beth Høeg, M.D., Ph.D.—who was named acting director of the agency’s Center for Drug Evaluation and Research (CDER) following the departure of veteran oncologist Richard Pazdur, M.D., last December—is now expected to depart in Makary’s footsteps, Reuters reported Friday, citing three sources familiar with internal plans at the regulator.” * * *
    • “Reuters clarified in its report that the CDER chief’s departure is likely, but that the decision has not yet been finalized.” 
  • and
    • “With the help of DNA testing company Natera and its personalized molecular residual disease (MRD) blood test Signatera, Roche’s PD-L1 inhibitor Tecentriq has chalked up its eleventh U.S. indication in the form of a new bladder cancer approval.
    • “Tecentriq and subcutaneous Tecentriq Hybreza can now be used as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) following a cystectomy, as identified by Signatera.” 
       
  • Biopharma Dive relates,
    • “The Food and Drug Administration has placed a clinical hold on Aardvark Therapeutics’ drug for Prader-Willi Syndrome, escalating a trial stoppage that began when signs of potential heart problems were detected in a study of healthy volunteers. 
    • “Aardvark said Thursday it will “unblind,” or reveal which enrollees in a late-stage trial received ARD-101, in order to help investigators and regulators determine whether the drug is safe and effective enough to continue testing in humans.
    • “The company has dosed 68 people in the placebo-controlled Phase 3 trial and another 19 in an open-label extension study, both which were intended to measure whether ARD-101 can address the “hyperphagia,” or insatiable hunger, distinctive to Prader-Willi. The cardiovascular concerns emerged from a safety trial in healthy people who’d received much higher doses than what was administered in the other studies.” 
  • Cardiovascular Business tells us,
    • “Stryker Sustainability Solutions, an Arizona-based division of Stryker focused on reprocessing single-use medical devices, has recalled certain lots of several reprocessed electrophysiology (EP) catheters. The recall, which covers more than 8,000 devices overall, was initiated after the company identified incomplete seals due to a process control issue.
    • “According to the U.S. Food and Drug Administration (FDA), this is a Class II recall. This means the agency believes the devices “may cause temporary or medically reversible adverse health consequences.”
  • The Wall Street Journal points out,
    • “Twenty people in Japan who took Amgen’s rare-disease drug Tavneos have died, and at least 22 developed a potentially fatal liver injury, according to Kissei Pharmaceutical, which sells the medicine in the country.
    • “Kissei told doctors Friday to stop prescribing the drug to new patients.
    • “The Japanese drugmaker said the 20 deaths occurred in people who had suffered a serious liver “impairment” and attributed 13 of the deaths to a condition, called vanishing bile duct syndrome, marked by the destruction of the ducts that carry bile out of the liver.
    • “Kissei said causal links to Tavneos hadn’t been confirmed in all 20 deaths.” * * *
    • “The medicine went on sale in Japan in 2022, according to Kissei. Also that year, Amgen bought the drug’s developer, ChemoCentryx, for $3.7 billion.
    • “In January, the FDA asked Amgen to voluntarily pull the drug from the U.S. market, but Thousand Oaks, Calif.-based Amgen refused.
    • “Then in March, the FDA said it had identified 76 global cases of serious liver injury linked to Tavneos, including eight deaths. Most were reported in Japan. Of the 76 global cases the FDA identified, seven involved the syndrome, and three of those patients died.
    • “In late April, the FDA moved to formally begin withdrawal proceedings.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of May 15, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue into May for some regions.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 51 new measles cases in a nationwide outbreak that has now reached 1,893 infections. All but nine cases are locally acquired, with the rest related to international travel.
    • “The agency reported two new outbreaks, for a total of 27. Last year the nation saw 48 outbreaks and 2,288 cases for the entire year. The United States could top that total in the coming months.
    • “Of this year’s cases, 21% involve children younger than 5 years, and 76% involve kids and young adults up to 19 years. Among all 2026 patients, 92% have been unvaccinated or have an unknown vaccine status. Six percent of patients this year have been hospitalized, compared with 11% last year.”
  • The American Hospital Association News relates,
    • “A Centers for Disease Control and Prevention report released May 14 found that U.S.-reported dengue cases in 2024 increased 359% above the annual average from 2010-2023. Dengue is a mosquito-borne viral disease that can cause mild to severe illness and death. There were 3,798 cases reported to the CDC in 2024, compared to the average of 828 from 2010-2023. The report found that 97.2% of cases in 2024 were travel-associated and that 2.8% were acquired locally. Individuals age 50-59 accounted for 21.8% of cases, and 57.5% of cases occurred in Hispanic or Latino individuals. In addition, 36.1% of patients were hospitalized and a total of six patients died. Most travel-linked cases were acquired in the Caribbean (34.1%), North America (24.3%) and Central America (15.6%).” 
  • Health Day informs us,
    • People who have survived a heart attack appear to have a higher risk of brain decline into dementia, a new study says.
    • On average, heart attack survivors have a yearly 5% increased risk of developing cognitive impairment, researchers reported today in the journal Stroke.
    • “Having had a heart attack in the past may speed up the decline in memory and thinking over time,” said lead researcher Dr. Mohamed Ridha, an assistant professor of neurology at Ohio State University in Columbus.
    • “Given the rising burden of dementia and cognitive decline among Americans, it is important to understand how cardiovascular disease affects their brain health,” Ridha said in a news release. “This knowledge can help heart attack survivors take steps to improve their brain health as they age.”
  • and
    • “Offering sigmoidoscopy screening reduces colorectal cancer (CRC) incidence in men and women — with a greater reduction among men — and reduces CRC mortality in men, according to a study published online May 12 in the Annals of Internal Medicine.
    • “Edoardo Botteri, Ph.D., from the Norwegian Institute of Public Health in Oslo, and colleagues report on the benefits of sigmoidoscopy after 23 years in a randomized controlled trial involving persons aged 50 to 64 years. A total of 100,210 persons were randomly assigned to screening with once-only sigmoidoscopy with or without one fecal immunochemical test or to no screening. The intention-to-screen analyses included 98,654 persons: 20,552 in the screening group and 78,102 in the no-screening group.
    • “The researchers found that the 23-year cumulative risk for CRC was 4.3 and 6.0 percent in the screening and no-screening groups, respectively, among men. The corresponding risks were 4.2 and 4.7 percent among women. In men, the 23-year cumulative risk for CRC death was 1.4 and 2.2 percent in the screening and no-screening groups, respectively, while in women, the corresponding risks were 1.3 and 1.4 percent. The strongest effect was seen for rectosigmoid cancer. Screening benefits were not changed with the addition of fecal blood testing.”
  • Healio adds,
    • “The survival benefit conferred by lung cancer screening in real-world settings may be smaller than observed in the pivotal trial on which national screening guidelines are based, study results suggest.
    • “Veterans receiving primary care in the VA health system exhibited a threefold higher risk for all-cause mortality than participants in the randomized National Lung Screening Trial (NLST) who had similar age and tobacco history.
    • “This is one of the first times we have been able to directly compare people who were enrolled in the trial with people in a real-world cohort who are eligible for screening,” Alison S. Rustagi, MD, PhD, assistant professor in University of California San Francisco’s department of medicine, told Healio. “It is not often that we see hazard ratios on the order of 3 in observational analyses. This shows a profound difference between these two populations.”
  • Per Medscape.
    • “Orforglipron, an oral GLP-1 receptor agonist, helps maintain weight loss after injectable therapies like tirzepatide and semaglutide, offering a practical continuation option for patients. Cardiometabolic benefits are largely preserved despite some weight regain.”
  • Per an National Institutes of Health news release,
    • “A group of pediatric eye disease researchers supported by the National Institutes of Health (NIH) has launched an open-access tool designed to help manage pediatric cases of amblyopia, a condition in which the brain fails to properly develop normal vision in one or both eyes early in life. It is the leading cause of preventable single-eye (monocular) vision loss, affecting three of every 100 children in the nation. The tool is aimed at expanding access to evidence-based amblyopia clinical-decision-making expertise amidst a shortage of pediatric eye care specialists in the United States.
    • “This online tool quickly distills the relevant literature into individualized treatment advice for busy clinicians anywhere with internet access. Those without internet access can utilize the article figures as clinical reference sheets,” said article lead author, Allison Summers, O.D., associate professor, Oregon Health & Science University, Portland.” * * *
    • “Known as the Amblyopia Navigator Decision-Support Instrument (ANDI), the tool is designed to guide any eye doctor through the diagnosis of amblyopia. Once amblyopia is diagnosed, ANDI helps to guide the eye care clinician without specialty training in pediatric eye care through management options. The tool helps the eye doctor determine the best glasses prescription for the patient based on a few clinical findings. The tool also helps the doctor determine how long to monitor whether glasses alone are improving vision, which can work for up to a third of children without any further treatment.
    • “If glasses are not enough, ANDI walks the eye doctor through next steps: patching the stronger eye for a couple of hours a day, using atropine eye drops to temporarily blur the stronger eye, or considering newer digital treatments delivered through specially designed games or videos. If a child stops making progress, the tool advises whether to increase the intensity of treatment, switch approaches, reassess the glasses prescription, or refer to a specialist. It provides steps for follow-up visits and what signs of recurrence to watch for after treatment ends. The tool can be used at an initial visit, or any follow-up visit in their amblyopia care journey.
    • “ANDI was developed by PEDIG, an NIH-funded research network with over 400 investigators, and it draws on evidence from 147 published studies. To access ANDI, go to https://public.jaeb.org/pedig.”

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

  • Mercer consulting offers “bold strategies” for payers to better control high cost members.
    • “While stop-loss coverage can help mitigate risk, many employers are finding it’s no longer enough. Unsurprisingly, “more focused management of high-cost claimants” is the top priority of large US health plan sponsors in their strategic planning for the next few years. In this post, we’ll discuss four areas where focused efforts can help employers rein in costs.”
      • Understand your data: Analyzing claims to gain clarity. 
      • Strategic oversight of medical specialty pharmacy and gene/cell therapies. 
      • Take a peekaboo view into neonatal intensive care unit management. 
      • Outlier inpatient stays.
  • Fierce Healthcare reports,
    • “CVS’ Omnicare unit has secured court approval to sell its business to virtual care company GenieRx Holdings, the healthcare giant announced Thursday.
    • “GenieRx, which offers an array of virtual health and medication services, is a joint partnership between Milrose Capital, a private equity firm, and Integro Asset Management, a healthcare-focused investment firm. Per court documents, the deal includes $250 million in cash as well as certain other liabilities, such as payroll expenses.
    • “In the announcement, CVS said that in combining with GenieRx, Omnicare will “have the opportunity to strengthen its service.” It will also continue to support it current clients in the lead up to closure, which is expected later this year, pending needed regulatory approvals.”
  • Beckers Hospital Review discusses “three barriers to GLP-1 adherence — and how systems are overcoming them.
    • Patients discontinue therapy early
    • Care models incompatible with sustained support
    • Costs and side effects deter patients.
  • Fierce Pharma tells us,
    • Total prescriptions for Eli Lilly’s Foundayo reached 10,248 for the week that ended May 8, up from 7,335 the prior week, according to IQVIA data cited by Citi. While still on the rise, Foundayo’s growth pace continued to lag behind that of Novo Nordisk’s Wegovy pill during the same stage of their launch. 
    • Wegovy’s total scripts rose by 1.3% week over week to nearly 446,000, as its share in the obesity GLP-1 market climbed 0.1 percentage point to 40.5%, according to Citi.
    • However, Wegovy’s growth apparently didn’t come from its oral formulation. Wegovy pill scripts landed at about 137,000 for the week, down from roughly 143,000 the prior week, marking the first time that the pill’s scripts have fallen since the oral launch in early January.
    • Scripts from the Wegovy pill made up 31% of total Wegovy scripts for the period, down 2 percentage points from the previous week. Still, Citi analysts argued that this roughly one-third of share “suggests preferences for oral formulations.”
    • Even as Wegovy gained ground, Lilly’s Zepbound remained the obesity market leader, with 59.5% share, as its nearly 656,000 scripts marked 0.8% growth week over week. 
  • Beckers Payer Issues offers payer perspectives on artificial intelligence tools.
    • “Using AI solutions to augment the work done by humans is an attractive solution for many payers.
    • “Getting started with these technologies, however, can feel daunting.
    • “To learn more about what it takes for payers to successfully incorporate AI and support more members, Becker’s Healthcare recently spoke with Chris Caramanico, CEO of Elligint Health, Amy Qureshi, RN, executive vice president of product strategy at Elligint Health, and Steven Tolle, chairman of the board at Elligint Health. Mr Tolle has significant experience developing and implementing AI from his time at IBM, Merge and IgniteData and addition serves as Chief of AI Strategy at Elligint Health.”
  • Fierce Healthcare adds,
    • Nearly 80% of payers now prefer implementing vendor-built artificial intelligence tools rather than developing internal capabilities, a new survey from Innovaccer found.
    • The survey draws insights from 63 health insurer organization leaders, including regional health plans to national carriers, the healthcare technology and AI company said in a press release. Respondents were polled in mid-December 2025 to mid-January, and include senior and C-suite executives.
    • Innovaccer CEO and co-founder Abhinav Shashank told Fierce Healthcare that the shift to outsourced solutions reflects the focus of how to “truly operationalize AI.” 
    • “What we are seeing is an emergence of how do you have platforms that companies can effectively offer that allow for more agentic orchestration,” Shashank said. “Because the reality of it is the technology is going to be a massive addition to how payers operate.” 
  • NBC News relates,
    • “Over the past two years, medical providers across America have quietly embraced a new AI tool called OpenEvidence to help them make clinical decisions, brush up on medical knowledge and even prepare for their licensing exams. The service, a sort of chatbot for doctors, was used by about 65% of U.S. doctors across almost 27 million clinical encounters in April alone, the company told NBC News.
    • “Everyone is using it,” said Dr. Anupam Jena, an internal medicine physician at Massachusetts General Hospital in Boston and a professor of healthcare policy at Harvard. “Its growth really has been exponential.”
    • “NBC News spoke with over two dozen doctors, hospital administrators, medical students and healthcare researchers from Hawaii to Maine to explore the rise of OpenEvidence. Each individual said they either used it regularly themselves or knew someone who did.
    • “Almost two-thirds of physicians — or roughly 650,000 doctors — in the U.S. actively use OpenEvidence, while another 1.2 million use it internationally, OpenEvidence representatives said. With its quick and tailored replies, OpenEvidence has become an AI-era equivalent of consulting a colleague for their expert opinion, though the software can also write patient discharge notes and provide custom study tools for doctors’ medical exams.”

Midweek report

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association reports,
    • “The Centers for Medicare & Medicaid Services today announced a six-month nationwide moratorium preventing enrollment of new home health agencies and hospice providers, effective immediately. CMS said that the moratorium is part of Vice President JD Vance’s Anti-Fraud Task Force and that the agency will use this time to intensify anti-fraud efforts within the sector.  
    • “In response to the moratorium, Ashley Thompson, AHA senior vice president of public policy analysis and development, said, “The AHA strongly supports CMS’ efforts to protect the integrity of the Medicare program and combat fraud. Yet, as we have stated previously, we are concerned about subjecting entire categories of providers or claims to restrictions due to the actions of a limited number of bad actors. There are many rural and underserved areas of the country where hospitals struggle to find appropriate discharge locations for patients, and home health agencies and hospice providers are essential to ensuring timely and safe next levels of care. This moratorium may exacerbate these existing difficulties. We therefore recommend CMS consider a more targeted, data-driven approach to identify bad actors while allowing quality care providers to continue to service Medicare beneficiaries.” 
  • and
    • “The AHA today urged Eli Lilly to abandon its 340B Drug Pricing Program claims-data policy and work with the AHA to develop a functional third-party clearinghouse. 
    • “Lilly’s policy is unprecedented,” AHA President and CEO Rick Pollack wrote in a letter to Eli Lilly’s CEO. “It will impose onerous costs on 340B hospitals, forcing our members to divert scarce resources away from patient care and toward unnecessary administrative requirements. And it risks limiting patient access to Lilly’s lifesaving, innovative drugs. We therefore invite Lilly to work in good faith with the AHA and our 340B hospital members to find a better path forward than the cycle of escalation that has beset the 340B program in recent years.” 
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Office on Women’s Health (OWH), today announced a new Memorandum of Understanding (MOU) with Heartland Forward to advance maternal health outcomes and improve care for women and families across the United States. This collaboration supports a shared goal of making the U.S. the safest place in the world to have a baby.
    • “Through this partnership, HHS and Heartland Forward will exchange information, align strategies, and collaborate on evidence-based initiatives to reduce maternal morbidity and mortality and strengthen care across the lifespan, including before, during, and after pregnancy.” * * *
    • “Heartland Forward, a non-profit, describes itself as a policy think-and-do tank focused on driving economic growth and stronger communities, established the Maternal and Child Health Center for Policy and Practice (MCH CPP) in 2025. MCH CPP has a stated focus on state-led, evidence-based strategies to improve outcomes, particularly in rural and underserved communities, with the goal of cutting U.S. maternal mortality in half within five years.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS), through its Health Tech Ecosystem, is advancing its electronic prior authorization efforts through a newly established Electronic Prior Authorization Acceleration initiative to address key challenges and drive solutions ahead of 2027 requirements. 
    • “30 healthcare organizations—including health systems, electronic health record developers, physician practices, networks, and digital health developers—have signed on as early adopters in this cross-sector effort. They join many of the nation’s largest payers that have already committed to working with CMS to identify and address workflow, technical, and operational barriers that have slowed adoption of electronic prior authorization across the healthcare system.
    • “Prior authorization won’t be fixed by technology alone. It requires the entire healthcare system to work together to solve real-world challenges,” said CMS Administrator Dr. Mehmet Oz. “CMS continues to bring organizations together to do just that, and these early adopters are choosing to lead. This work will help reduce administrative burden, giving clinicians more time to focus on patients and helping people get care faster.” * * *
    • “CMS encourages organizations across the healthcare system—including providers, technology developers, and network partners—to join this initiative and help accelerate progress toward a more efficient, transparent, and patient-centered prior authorization process.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “The FDA has alerted healthcare providers and patients about an increased risk of new blood cancers tied to Tazverik (tazemetostat) and said the drug’s sponsor plans to withdraw the product from the U.S. market.
    • “Tazverik was approved under the FDA’s accelerated approval pathway in 2020 to treat patients 16 and older with metastatic or locally advanced epithelioid sarcoma and certain adults with relapsed or refractory follicular lymphoma. The agency said new data showed the risks of treatment outweigh the drug’s benefits.
    • “According to a May 11 FDA safety alert, 18 out of 318 patients, or 5.7%, treated with Tazverik in the Phase 1b/3 Symphony-1 trial developed hematologic second primary malignancies, compared to no reported events in the control arm. The cancers included myelodysplastic syndrome, acute myeloid leukemia, B-cell acute lymphoblastic leukemia and clonal cytopenia of undetermined significance.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The number of people who died from drug overdoses dropped again in 2025, a promising trend as the U.S. emerges from a national fentanyl crisis that accelerated these fatalities.
    • “There were an estimated 69,973 drug-overdose deaths in 2025, a nearly 14% drop from a year earlier, according to preliminary data released by the Centers for Disease Control and Prevention on Wednesday. 
    • “Drug-overdose deaths have now declined for three consecutive years, falling to levels closer to those not seen since before the Covid-19 pandemic, which intensified the drug-overdose crisis. 
    • “For us, finally, to be seeing some sustained declines is very promising,” said Farida Ahmad, a health scientist with the CDC’s National Center for Health Statistics.”
  • STAT News relates,
    • The United States is hardly the only country where heavy and binge drinking is a problem. But Americans face a unique crisis: This country’s obesity and diabetes epidemics, combined with heavy alcohol use, are causing more people to get sick from a liver disease that, until recently, didn’t even have a name. 
    • Metabolic dysfunction and alcohol-associated liver disease, or MetALD, is now a leading concern among doctors in the U.S. as more young people and women face serious illness and die from the condition. Doctors worry that many more Americans might be silently developing MetALD, at least in part because many people do not realize they are drinking too much.” * * *
    • “MetALD is now nearly twice as common as alcohol-associated liver disease, and the risk factors are hitting younger adults: People 26 to 34 years old have the most overlapping alcohol use disorder and obesity of any age group, national survey data reveal.”
       
  • Beckers Payer Issues tells us,
    • “For the second consecutive year, Vermont ranked as the healthiest state for older adults in the U.S., according to the United Health Foundation’s “America’s Health Rankings 2026 Senior Report.”
    • “The United Health Foundation is a nonprofit founded by UnitedHealth Group. State health rankings are based on 36 measures spanning social and economic factors, physical environment, behaviors, clinical care, and health outcomes.
    • “The early death rate for adults aged 65 to 74 dropped 2% between 2023 and 2024. However, compared to 2019 to 2021, drug deaths were up 38% for older adults from 2022 to 2024. Suicides increased 4% over the same period. Excessive drinking increased 10% for older adults between 2023 and 2024.
    • “The workforce serving older adults has grown in recent years, including home healthcare workers and geriatric clinicians.”
  • Endocrinology Advisor informs us,
    • “Younger adults with type 2 diabetes (T2D) exhibit worse glycemic control and greater obesity than older adults with T2D, according to results of a study published in the Journal of the Endocrine Society.
    • “In general, earlier T2D onsets are associated with greater burden of morbidity and mortality. However, there may be subpopulations of early-onset T2D.”
  • Medscape lets us know,
    • “The once-daily oral GLP-1 receptor agonist orforglipron (Foundayo, Eli Lilly) produced clinically meaningful weight loss in adults aged 65 and older, whether or not they had type 2 diabetes (T2D). Its safety profile also closely mirrored the one seen in younger patients, according to a post hoc analysis of the phase 3 ATTAIN clinical trial program. 
    • “The findings may help address longstanding uncertainty and a lack of robust evidence around the use of GLP-1 receptor agonists in older adults. This group is often underrepresented in obesity trials and considered more vulnerable to reduction in lean muscle mass, potentially precipitating frailty, sarcopenia, falls, fractures, and renal complications. They also have a high prevalence of obesity and cardiometabolic disease. 
    • “This data provides the information clinicians needed to feel confident prescribing orforglipron to older individuals who often have many other medications and health concerns,” lead author, Deborah Horn, DO, MPH, director of the Center for Obesity Medicine and Metabolic Performance at McGovern Medical School at UTHealth Houston, told Medscape News Europe.”
  • BioPharma Dive adds,
    • “Eli Lilly is offering new data suggesting its medicines can help patients who take injectable GLP-1 drugs keep most of the weight off long-term.
    • “The research included patients who achieved significant weight loss with either Lilly’s Zepbound or Novo Nordisk’s Wegovy. Researchers wanted to see how patients fared for another year when given the same treatment, a lower-dose version of an injection or Lilly’s newly launched Foundayo pill. In both trials, the medical options significantly outperformed placebo.
    • “Lilly detailed the studies on Tuesday to coincide with their presentation at an obesity conference in Europe and publication in medical journals. One of the trials, dubbed Surmount-Maintain, was published in The Lancet, while the other, Attain-Maintain, appeared in Nature Medicine. Lilly had given investors a preview of the Nature Medicine research in December.”
  • Genetic Engineering and BioTechnology News points out,
    • “A study headed by researchers at King’s College London and the University of Porto has mapped the histamine system in the brain. Histamine, a molecule more commonly associated with allergies, plays a separate but poorly understood role in brain function. The new study addresses this gap, building the first multiscale map of the histamine system which spans from genetics to behavior and related mental health conditions.
    • “The findings provide a new framework for understanding how this often-overlooked chemical system contributes to brain function and could point towards new treatment strategies for histamine-related conditions such as depression, ADHD, and schizophrenia. The study was funded by the National institute for Health and Care Research (NIHR) Maudsley Biomedical Research Centre.”

From the U.S. healthcare business front,

  • CMS released 2026 hospital star ratings today.
    • Beckers Hospital Review tells us,
      • “Ninety-four more hospitals earned a five-star quality rating from CMS in 2026 compared to 2025. 
      • “CMS publishes its Overall Hospital Quality Star Ratings annually. The ratings, updated May 13, reflect a hospital’s performance across five quality measures: mortality, safety, readmission, patient experience, and timely and effective care. Read more about how CMS calculates star ratings here.
      • “Read the list of CMS’ one-star hospitals here.”
      • The article lists the 385 hospitals that won five stars this year.
    • and
      • identifies the health systems with the most five-star hospitals in 2026, according to CMS data released May 13.
  • Modern Healthcare reports,
    • “Health insurance companies including UnitedHealth Group and Elevance Health are bolstering their reserves to safeguard against tougher times ahead. 
    • “Several major insurers conveyed confidence and raised earnings guidance when announcing their first-quarter financial results, suggesting the industry is surmounting challenges that have squeezed earnings in recent years.
    • “That’s put companies such as the UnitedHealth Group, Elevance Health and Alignment Healthcare in a position to stockpile cash after they raised premiums and cut down on spending.
    • “It’s a nice rainy day fund they can dip into,” said Michael Ha, a senior research analyst at the investment bank Baird.
    • “Elevance Health and UnitedHealthcare parent company UnitedHealth Group reported year-over-year increases in days claims payable of 2.6 and 3.1, respectively. Days claims payable measures the percentage of claims held in reserve, with a larger ratio indicating stronger reserves.”
  • The American Journal of Managed Care informs us,
    • “COVID-era policy changes rapidly increased virtual care use, enabling a difference-in-differences comparison of high- vs low-adoption regions using a national, multi-payer claims database. 
    • “Across payer groups and Census regions, higher telemedicine adoption showed no significant change in visits or total spending; confidence intervals crossed zero for all primary estimates. 
    • “Subgroup analyses by geography, income, and social vulnerability remained null, with nonsignificant trends toward modest savings in several urban and safety-net–adjacent populations. 
    • “Limitations included inability to assess quality or outcomes, limited race/ethnicity stratification, and regional-level inference constraints despite large-scale, consistent findings.”
  • Medscape points out,
    • “Preventive care prioritization can enhance patient outcomes, with preexposure prophylaxis and breast cancer risk-reduction medications offering significant quality-adjusted life years. Efficient use of physician time is crucial for maximizing these benefits.” * * *
    • “The top six interventions by patient quality years gained were:
      • “Prescribing preexposure prophylaxis for patients with high-risk sexual activity (0.41 QALYs) and intravenous drug use (0.13)
      • “Offer to prescribe medications to reduce the risk for breast cancer(0.21)
      • “Prescribe statins for primary prevention for adults aged 40-75 years at high risk for cardiovascular disease (0.12)
      • “Screen for alcohol use and provide brief behavioral counseling for adults with hazardous drinking behaviors (0.11)
      • “Weight-loss counseling and referral to a dietician for adults with obesity(0.07)
    • “When physician time was factored in, the top four services maintained their position but hepatitis B screening for high-risk patients (1.19) and hypertension screening (0.74) rose in value.”
  • CVS Health offers a 2026 GLP-1 outlook: A strategic roadmap to manage spend and trend.
  • Beckers Hospital Review notes,
    • “Use of manufacturer-sponsored coupons for brand-name drugs declined among commercially insured patients between 2017 and 2024, even as the value of coupon offsets increased, according to a study published April 6 in JAMA.
    • “The study analyzed pharmacy claims data from 3,243,061 commercially insured patients covering 55,325,139 claims for brand-name drugs without generic competition. 
    • “The findings come as alternative drug purchasing and pricing models continue to expand, giving patients and health systems another channel to access brand-name and generic drugs at transparent prices without relying on manufacturer incentives. The Trump administration launched TrumpRx.gov in February, which now lists over 50 discounted brand-name drugs tied to most-favored-nation pricing agreements. Mark Cuban Cost Plus Drug Co. has also expanded its direct-pay pharmacy and wholesale operations.”

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend update

David Ermer–ACA, CDC, Congress, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare–

Happy Mothers Day!

  • Per an HHS news release,
    • “On Mother’s Day, the U.S. Department of Health and Human Services launched Moms.gov, a groundbreaking website for new and expecting mothers. This first-of-its-kind resource offers guidance and information to support the health and well-being of mothers and their families.
    • “Moms.gov also supports expecting parents who are navigating difficult or unexpected pregnancies. It features information about pregnancy centers, Federally Qualified Health Centers, nutritional guidance, Trump Accounts, and other resources that allow maternal and infant health to thrive.”
  • Per a Labor Department news release,
    • “The U.S. departments of Labor, Health and Human Services, and Treasury announced a proposed rule that would create a new category of limited excepted benefits to further expand the ability of employers to offer meaningful fertility benefits to their employees. 
    • “The proposed rule is a central component of the Trump administration’s efforts to expand American families’ access to fertility benefits. It builds upon President Trump’s Executive Order “Expanding Access to In Vitro Fertilization,” which announced that it is the policy of the administration to ensure reliable and affordable access to in vitro fertilization to support American families.” * * *
    • “The proposed rule would establish a new category of limited excepted benefits. Excepted benefits are generally exempt from the market reforms under the Affordable Care Act and certain other federal health care coverage laws. This new category would apply limiting principles similar to those already in place for other limited excepted benefits. 
    • “The proposed rule sets a few main requirements for the benefits: 
      • “Substantially all of the benefits must be for diagnosis, mitigation, or treatment of infertility or related reproductive health conditions.
      • “Benefits are capped at a combined lifetime maximum of up to $120,000 for the participant and their beneficiaries, indexed for inflation for plan years starting after 2028.
      • “Employers must provide a notice that clearly describes the coverage and meets other specified requirements.
    • “Comments are due 60 days from its publication in the Federal Register. 
    • “Read the notice of proposed rulemaking on limited excepted fertility benefits.”
  • While the FEHBlog has not yet read the proposed rule, he noticed that the proposed rule amends the Public Health Service Act and therefore may impact the FEHB and PSHB programs.

From Washington, DC,

  • Tomorrow, the Senate will take a final vote on S. Res. 690, “authorizing the en bloc consideration in Executive Session of (49) certain nominations on the Executive Calendar.” The FEHBlog does not notice any noteworthy nominations on that list.
  • Here is a Roll Call discussion of other actions under consideration on the Hill this week.
  • Federal News Network reports,
    • “The Postal Service is floating the possibility of Congress stepping in to provide more financial assistance to keep the largely self-funded agency from running out of cash early next year.
    • “Postmaster General David Steiner said USPS hasn’t officially pitched the idea to Congress, but it’s an option lawmakers should consider to get the agency on firmer financial footing. Steiner said USPS will spend the next month refining its wish-list of legislative proposals before sharing it with Congress.
    • “Steiner told members of the House Oversight Committee in March that USPS will run out of cash in early 2027, as long as it continues to pay its bills on time. But USPS is relying on some emergency measures to conserve cash.
    • “To the credit of Congress, they’re not looking for short-term band-aids, but for long-term solutions,” Steiner said Friday at a public meeting of the USPS Board of Governors.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • ‘The U.S. Centers for Disease Control and Prevention is sending staff to the Canary Islands to meet a cruise ship with a hantavirus outbreak.
    • “The MV Hondius has a hantavirus outbreak that has killed three people and infected five others; the rare Andes variant is confirmed.
    • “Seventeen American passengers from the ship will be quarantined at the University of Nebraska Medical Center’s National Quarantine Unit.” * * *
    • “The facility looks more like a hotel than a hospital. People quarantining at the center are asked not to leave their rooms and receive, essentially, room service brought to their door, said Dr. Michael Wadman, medical director of the National Quarantine Unit at University of Nebraska Medicine.” * * *
    • “If any cruise ship passengers are quarantined and develop symptoms, they will be moved to the nearby Nebraska Biocontainment Unit—a facility isolated from the rest of Nebraska’s medical center, designed to treat patients infected with highly hazardous infectious diseases, according to Nebraska Medicine.
    • “A CDC official said Saturday that ship passengers will be monitored for around six weeks, or 42 days, but not necessarily only in Nebraska. The official said authorities will coordinate with some passengers and local jurisdictions for at-home monitoring, though it wasn’t clear how many people were going home or when.”
  • MedPage relates,
    • “The CDC has issued a Health Alert Network (HAN) health advisory on hantavirus, urging clinicians to be aware of the potential for imported cases of hantavirus disease in connection with an outbreak of Andes virus aboard a cruise ship.
    • “While the risk of broad spread in the U.S. is “considered extremely unlikely at this time,” the agency noted that early symptoms can be easily confused with influenza or other viral illnesses. In addition, the virus may not be accurately detected in body secretions and excretions within the first 72 hours of symptom onset, so testing should be repeated after that window, the agency warned. * * *
    • “Several state health departments — including Arizona, California, Georgia, and Texas — confirmed to MedPage Today that they are monitoring individuals in their respective states. New Jersey also is monitoring two peopleopens in a new tab or window who were on the same flight as a woman who was symptomatic on board and later died.”
  • The Wall Street Journal tells us “After the hantavirus uutbreak here’s what cruise travelers should know.”
    • “The hantavirus outbreak aboard the MV Hondius has revived memories of Covid-era cruise chaos. Infectious-disease doctors say the current situation is very different.”
  • The Wall Street Journal also reports,
    • “A study of more than 57,000 iPhone users confirmed a correlation between hearing loss and slower walking speeds.
    • “The Apple and University of Michigan study used data people agreed to share via Apple’s Research app.
    • “Doctors state addressing hearing issues could lead to a longer, healthier life and recommend annual hearing tests.”
  • Healio informs us,
    • “Among adults with obesity, the risk for new physician-reported sleep apnea and new-onset obstructive sleep apnea significantly fell if they used vs. did not use a GLP-1 agonist, according to data from two studies.
    • “Both studies were published in Annals of the American Thoracic Society.“

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

  • HR Dive reports,
    • “The merit increases employers awarded this year were only slightly below previous projections, with a mean 3.1% merit increase, versus a 3.2% projection in October 2025, according to the latest Mercer QuickPulse Compensation Planning Survey.
    • “Average total increases were 3.4%, versus a predicted 3.5%, per the report. 
    • “Meanwhile, just 4% of employers gave workers equal, across-the-board salary increases, also called “peanut butter” raises, rather than merit increases, Mercer found. Most still use a combination of individual performance and position relative to market value or relative to peers.”
  • Healio relates,
    • “The AI tools that benefit clinicians most are not always the glamourous ones contributing to drugs, robotics and therapeutics innovations, but could also be the mundane ones that help ease physician burnout. 
    • “That is according to David Ting, MD, keynote speaker at Digestive Disease Week.
    • “Ting, chief clinical product lead at Microsoft and primary care internist and pediatrician at Massachusetts General Hospital, told attendees he envisions a 2036 where AI products assist with the ordinary: workflow redesign, administrative burden and workplace collaboration.
    • “AI also might one day take center stage in reshaping the clinical environment and restoring the “joy of practice,” he said.”
  • BioPharma Dive tells us,
    • “Odyssey Therapeutics, a maker of medicines for autoimmune disorders, has brought in $279 million through an initial public offering that’s been more than a year in the making.
    • “Selling 15.5 million shares at $18 each, Odyssey on Thursday raised more than what it expected and became the latest drug company of late to top $250 million in IPO proceeds. The company also added another $25 million to its haul via a concurrent private stock sale at the IPO price. Odyssey is now the 11th biotech company to go public so far this year, according to BioPharma Dive data, and will start trading on the Nasdaq stock exchange on Friday under the ticker symbol “ODTX.”
    • “Odyssey is led by Gary Glick, a biotech veteran who’s led multiple drug startups that were later acquired. Glick launched the company in 2021 with backing from the likes of OrbiMed and SR One, and it’s since netted $727 million in venture funding.”
  • Healthcare Dive informs us,
    • “Staffing technology company Cross Country Healthcare has entered into an agreement to be acquired by private equity firm Knox Lane in an all-cash deal worth $437 million.
    • “The acquisition, which will take Cross Country private, values the company at $13.25 per share, a 31% premium over the staffing firm’s closing stock price on Wednesday, according to a press release. It’s expected to close in the third quarter if the deal clears regulatory approval.
    • “The deal comes months after Cross Country and travel nursing agency Aya Healthcare abandoned plans to combine following antitrust scrutiny from the Federal Trade Commission.”
  • That’s a better outcome than Spririt Airlines experienced.  

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.”

Weekend update

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

From Washington, DC

  • Both the Senate and the House of Representatives are on State/District work breaks this week.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services has begun collecting private payor rate data through its Fee-for-Service Data Collection System Clinical Lab Fee Schedule Module. CMS has created a guide for hospital outreach laboratories to determine their applicable status. An FAQ on Protecting Access to Medicare Act reporting is also available, as well as a booklet on reporting scenarios and examples. Next, applicable laboratories must complete the registration process to access the module. Laboratories must then gather their data and complete submission by July 31.”
  • and
    • “The Centers for Medicare & Medicaid Services has opened registration for its seventh annual CMS & Health Level Seven International Fast Healthcare Interoperability Resources Connectathon from July 14-16. The free virtual event will involve health care interoperability leaders, implementers and innovators collaborating for hands-on testing and shared learning on how CMS policies and FHIR-based solutions are being operationalized in real-world systems. Registration will be open through June 30.”

From the Food and Drug Administration front,

  • The Hill reports,
    • Thousands of tins of infant formula have been recalled over a toxin that could lead to illness among babies who consume it, according to a notice posted by the U.S. Food and Drug Administration.
    • In the notice, shared Saturday [May 2], the FDA said a2 Milk Company of Colorado had issued a voluntary recall of three batches of its a2 Platinum Premium USA formula, advertised for children who are 12 months old and younger.
    • “Cereulide, a toxin created by some strains of the Bacillus cereus bacterium, was found to be present in the formula, the notice warns. The toxin, which is not eliminated even when the formula is prepared with hot water, can make infants sick within as little as 30 minutes.”
  • BioPharma Dive relates,
    • “The Food and Drug Administration on Friday approved a particular kind of protein-degrading medicine for the first time, green-lighting biotechnology firm Arvinas’ Veppanu for use in treating certain people with a common form of breast cancer.
    • “Formerly known as vepdegestrant, Veppanu is approved for a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one endocrine therapy. The clearance makes the treatment available specifically to people who fit that criteria and have mutations to a gene called ESR1.
    • “Veppanu is what’s called a “PROTAC,” or proteolysis-targeting chimera. The drug works by taking unwanted proteins — in Veppanu’s case, estrogen receptors — that are linked to disease and trashing them via the cell’s natural waste disposal system. Most approved medicines, by contrast, bind to a molecular target and block or amplify its activity.
    • “This milestone demonstrates that targeted protein degradation can translate into meaningful clinical impact,” said Arvinas CEO Randy Teel, in a statement.” 
  • The Wall Street Journal adds,
    • “British pharmaceutical group AstraZeneca AZN said it would continue to work with U.S. regulators on a review of its breast-cancer candidate after the drug failed to get backing at a key advisory committee vote.
    • “The Food and Drug Administration’s oncologic drugs advisory committee voted six to three against the benefit-risk profile of camizestrant, a candidate drug for the treatment of breast cancer, the FTSE 100-listed drugmaker said late Thursday [April 30].
    • “AstraZeneca will continue to work with the FDA as it completes its review of the application,” it said. The regulator isn’t bound by the committee’s guidance, but takes its advice into consideration.
    • “We strongly believe in the results of the Serena-6 trial [testing camizestrant], and are encouraged that the committee saw camizestrant as a safe and effective potential new medicine,” Astra’s Susan Galbraith said.”
  • Per Fierce Pharma tells us,
    • “AstraZeneca fared better during the second vote at its meeting with the FDA’s Oncologic Drugs Advisory Committee (ODAC) this week. 
    • “On Thursday [April 30], the panel of outside experts voted 7 to 1, with one abstention, in favor of AZ’s bid to propel a regimen of Truqap plus abiraterone (J&J’s Zytiga) and androgen deprivation therapy (ADT) toward approval in PTEN-deficient metastatic hormone-sensitive prostate cancer. 
    • “The committee was swayed on the regimen’s risk and benefit in part by data from AZ’s phase 3 CAPItello-281 trial, in which the Truqap combo helped slash the risk of radiographic disease progression or death by 19% and reached a 7.5-month improvement in median radiographic progression-free survival over a control of Zytiga and ADT.”
  • Per an FDA news release,
    • “Today [May 1], the U.S. Food and Drug Administration is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib. 
    • “The expanded access treatment protocol is for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA received the expanded access request from Revolution Medicines on April 28 and signed it on April 30.” * * *
    • “Granting the request two days after receiving the expanded access application reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Having taken care of many patients with metastatic cancer, I am hopeful that today’s action will improve the lives of patients suffering from this disease.”
    • “Daraxonrasib is a RAS inhibitor designed to inhibit a protein (RAS) that is mutated in most pancreatic cancer tumors.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced on May 1:
    • “As of May 1, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue into May for some regions.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity continues to decrease. Influenza A activity is low across all regions and influenza B activity continues to trend downward.”
  • The University of Minnesota’s CIDRAP adds,
    • Utah this week added 18 more measles cases to its 2026 tally, for a total of 428, while Arizona posted two new cases in its ongoing outbreak, for 93 so far this year, according to their respective state health departments. The outbreak in Utah is currently the largest in the nation.
    • “The nationwide measles infection total for the year to date stands at 1,814, up from 1,792 last week, the Centers for Disease Control and Prevention said today in its weekly update.
    • “Of the national total, 1,803 measles cases were reported by 37 states and New York City. The remaining 11 were diagnosed in international visitors to the United States. Since the beginning of the year, 24 new outbreaks have been noted, and 93% of cases are outbreak-associated (415 from outbreaks starting this year and 1,273 from those that began in 2025). In all of last year, 2,288 measles cases were confirmed. 
    • “This year, 51% of measles infections have occurred in children and adolescents aged 5 to 19 years, and 21% were diagnosed in those younger than 5 years. Among all patients, 92% were unvaccinated or had an unknown vaccination status, while 4% had received only one dose.”
  • The Wall Street Journal reports.
    • “We’ve built a world that can numb discomfort instantly, and we’re surprised we feel less alive. 
    • As artificial intelligence makes life frictionless, we risk removing the very frictions that keep human beings healthy: effort, challenge, learning and forward motion. The next public-health crisis may be stagnation, not stress. 
    • “The fix isn’t another pleasure. It’s progression.
    • “Progression is not simply about moving forward; nor is it about constant achievement or relentless productivity. It is about adaptation: the way a muscle grows stronger when challenged, or a mind becomes more flexible when it explores. 
    • “Progression is engaging in challenges that expand our future capacity—physically, behaviorally and mentally. When we do this consistently, as research conducted in my own labs (as well as many others) shows, we improve mood, strengthen resilience, enhance health and slow many processes associated with aging. 
    • “Humans thrive when they grow. This matters biologically.”
  • The Washington Post relates,
    • ‘For decades, a mysterious, two-lobed organ nestled behind the breastbone has been overlooked by most physicians, thought to be a largely useless lump for most of human life: the thymus.
    • “The ancient Greeks posited this knob of tissue might be the seat of the soul. In the early 1960s, a Nobel laureate dismissed it as a mere graveyard for cells, “an evolutionary accident of no very great significance.” Today, scientists know the thymus plays an essential role in setting up a functioning immune system in childhood, but then starts to rapidly shrink into obsolescence in puberty.
    • “Now, a raft of research is recasting the thymus from a bit player to a potent regulator of aging and immune health across the lifespan.
    • “Studies highlight the crucial role it might play in longevity, as well as protecting against cancer, autoimmune disease and cardiovascular risk. The work has ignited interest in finding ways to rejuvenate the thymus, slow its decay and better understand its function.
    • “It was completely assumed the thymus would become irrelevant,” said Hugo Aerts, director of the Artificial Intelligence in Medicine Program at Mass General Brigham. In studies published in Nature, Aerts and colleagues found that people with a healthier thymus were less likely to develop lung cancer or to die of heart disease — or any cause. They also responded better to cancer immunotherapy treatments.
    • “Key questions remain: Is the thymus the driver of these improved health outcomes or an indirect barometer of better overall health? Why does its decline vary between different people, and can that be slowed or stopped? And, perhaps most fundamentally, why did it take so long to reconsider the thymus?”
  • The New York Times points out “three medical routines that older people may not need>
    • “Some screenings and treatments no longer make sense for patients as they age. Researchers have just added a few more to the list.”
  • MedPage Today notes,
    • “Infection remains a top cause of maternal mortality with most infection-related maternal deaths being preventable, a descriptive study of Maternal Mortality Review Committee (MMRC) data found.
    • “Only half of moms who died from infection-related causes within 1 year of the end of pregnancy (51.5%) had confirmed receipt of antibiotics and only 11.8% had received antibiotics within the recommended 1 hour, reported Naima T. Joseph, MD, MPH, of Boston Medical Center and Boston University School of Medicine, in a presentation at the American College of Obstetricians and Gynecologistsopens in a new tab or window (ACOG) annual meeting.” * * *
    • “ACOG attendee Sophia Drosinos, MD, of Viva Eve in New York City, told MedPage Today that the findings were “gut wrenching.”
    • “Drosinos, who was not involved in the research, noted that “most hospitals now have some sort of sepsis protocols very early on in somebody’s presentation,” but that she hoped hopefully hospitals will include all of the strategies outlined in the study to decrease maternal mortality.”
  • Per a National Institutes of Health news release,
    • “A team of National Institutes of Health (NIH) scientists and international colleagues have reported the first evidence from a randomized controlled clinical trial indicating that a GLP-1 receptor agonist can reduce the days in which patients with obesity and alcohol use disorder engage in heavy drinking. Led by researchers at Copenhagen University Hospital, the new study adds to a growing body of evidence suggesting that GLP-1s could be useful in treating alcohol use disorder.
    • “Very few medications are currently approved for alcohol use disorder, and these are vastly underutilized. A new option that is more accessible and more effective could be a gamechanger for closing the treatment gap,” said Director of NIH’s National Institute on Alcohol Abuse and Alcoholism (NIAAA) George Koob, Ph.D., a study co-author.”
  • Medscape significantly adds,
    • “GLP-1 medications may cause slight muscle loss, but benefits outweigh concerns. Weight loss, whether through GLP-1s or lifestyle changes, can reduce muscle mass. Resistance training and adequate protein intake are recommended to mitigate muscle loss.”
  • Health Day lets us know,
    • “Higher intake of legumes and soy products is associated with fewer chronic obstructive pulmonary disease (COPD) symptoms among former smokers, according to a study published online Feb. 23 in Chronic Obstructive Pulmonary Diseases.”

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

  • The Wall Street Journal reports,
    • Eli Lilly LLY Chief Executive Dave Ricks was on stage with Nvidia NVDA founder Jensen Huang earlier this year in San Francisco touting the company’s tech prowess when Huang teased him about the painstaking process of developing new drugs.” 
    • “I’m really hoping that your industry moves from drug discovery which is kind of like wandering around the forest looking for truffles,” Huang said, in front of a crowd of biotech and pharma investors.
    • “Indeed, Ricks and the rest of the pharmaceutical industry are looking to expand beyond collecting soil samples and bark pieces to find new drugs and are instead turning their hopes—and investment dollars—to AI. Lilly first announced a partnership with chip-maker Nvidia in October to build what it called the industry’s most powerful supercomputer, and expanded that in January with a $1 billion, five-year collaboration mixing their scientists and engineers in a new Bay Area lab aimed at discovering new medicines with AI tools.
    • “They aren’t alone. Rival Roche has already announced it is building an even bigger supercomputer in partnership with Nvidia. Companies such as GSK, AstraZeneca and Merck have announced billions of dollars worth of partnerships in recent months with tech and AI-focused biotech companies aimed at fully exploiting AI.
  • BioPharma Dive relates,
    • “Moderna topped Wall Street analysts’ expectations in reporting higher-than-expected revenue in the first quarter, adding to an ongoing turnaround that’s helped the company nearly double its market value since late last year.  
    • “The vaccine maker reported first-quarter sales of $389 million, more than tripling its total during the same period a year ago — a surge primarily fueled by international sales of its COVID-19 vaccine. The company did, however, report a net loss of $1.3 billion, about $1 billion more than a year ago, due to charges related to a litigation settlement with Arbutus Biopharma and Genevant Sciences.”
  • Fierce Pharma tells us,
    • “Shortly after laying out $75 million upfront for Corstasis Therapeutics and its congestive heart failure edema drug Enbumyst, Esperion Therapeutics is itself being acquired and taken private by healthcare investment firm Archimed. 
    • “On Friday, the companies announced that Archimed will pay $3.16 per share for Esperion at closing on May 1, alongside a potential CVR sweetener of contingent milestone payments tied to the future sales performance of Esperion’s Nexletol, Nexlizet and Enbumyst that could reach up to $100 million. 
    • “All told, the deal could be worth up to $1.1 billion, assuming those commercial milestones are met, the companies said in a release. The upfront consideration from Archimed marks a 58% premium on Esperion’s closing share price on April 30.” 
  • Fierce Healthcare informs us,
    • “Omada Health has signed on with Optum Rx to participate in its Weight Engage program, furthering the company’s ability to scale its offerings to reach more people who need cardiometabolic care and support.
    • “The pharmacy benefit management giant—which is one of the industry’s Big Three firms—launched the program in response to the demand for GLP-1s, as patients seeking these drugs face spotty coverage and often a thicket of barriers in the way.
    • “Optum said in a post that adherence can also be a challenge, as some patients may face uncomfortable side effects, or may be unresponsive to the medications. That makes having a more holistic, wrap-around model in place to support their journey crucial, the PBM said.
    • “That’s where Omada comes in. Optum is also working with Calibrate and Virta Health under the program, per the announcement.”
  • Medscape notes,
    • “The rapid rise of GLP-1 medications, coupled with declining rates of bariatric surgery, is causing a notable shift in obesity care. Rather than shuttering, however, bariatric surgery practices are choosing to reshape and expand their offerings. 
    • “Private practices and hospital-based bariatric centers alike are broadening their offerings to include not only surgery but also GLP-1 therapies and other medical treatments, along with psychological support, nutrition services, and, in some cases, body contouring procedures to address post-weight loss concerns.
    • “The goal, those involved said, is to create a one-stop center for obesity care, reflecting a growing, research-driven understanding that optimal management does not pit surgical against medical treatments but often requires both to address a lifelong chronic disease.”
  • Beckers Hospital Reviews seeks to share Mark Cuban’s playbook with readers.

Notable Death

  • Genetic Engineering and Biotechnology News reports,
    • “J. Craig Venter, PhD, the founder, board chair, and CEO of the J. Craig Venter Institute (JCVI) has died in San Diego following a brief hospitalization for unexpected side effects that arose from the treatment of a recently diagnosed cancer, reported the JCVI in a press statement.
    • “Venter helped define modern genomics and launch the field of synthetic biology. He was skillful in building interdisciplinary teams, pushing for new ideas and faster methods, and insisting that discovery should translate into real-world impact. He was also a major advocate for strong federal science funding and for partnerships that accelerate progress across government, academia, and industry.”
    • “Craig believed that science moves forward when people are willing to think differently, move decisively, and build what doesn’t yet exist,” said Anders Dale, PhD, president of JCVI. “His leadership and vision reshaped genomics and helped ignite synthetic biology. We will honor his legacy by continuing the mission he built—advancing genomic science, championing the public investments that make discovery possible, and partnering broadly to turn knowledge into impact.”
    • “Venter has been recognized as an essential force in the impetus to evolve genomics from a slow, academic discipline into a fast-moving, data-driven, and commercially relevant enterprise, leaving a lasting imprint on biotechnology, medicine, and synthetic biology,” says John Sterling, GEN’s Editor in Chief, who has known and worked editorially with Venter over the past 35 years.
    • “Venter was controversial and often challenged the scientific orthodoxy, with critics accusing him of hype and going overboard on privatization. To many, he was a visionary focusing on technological acceleration and blending academic science with the zeal of an entrepreneur. Supporters saw him as a pioneer who sped up genomics by years.”
  • Mr. Ventner was 79 years old at the time of his death. RIP.

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.”

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

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.”