From Washington, DC

• The Senate has adjourned until next Monday with no sign of when the President’s nominee for OPM Director Scott Kupor will receive floor consideration. According to the Senate Executive Calendar, there are many nominees besides Mr. Kupor patiently waiting their turn.

• Federal News Network offers an article about Wednesday’s House Oversight Committee markup and passage of its budget resolution.

• Per a Senate press release,
  • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, applauded the U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) announcement of Generation Gold Standard, a new initiative to pursue a universal vaccine platform for viruses that are most likely to cause pandemics. HHS Secretary Kennedy and NIH Director Bhattacharya announced the initiative to protect people against multiple strains of widely contagious viruses through a beta-propiolactone (BPL)-inactivated, whole-virus platform.  
  • “Scientists have long considered universal vaccines as the Holy Grail solution to protect Americans from quickly mutating viruses,” said Dr. Cassidy. “I am glad that Secretary Kennedy and the Trump administration are prioritizing this important area of research so we can be better prepared to tackle tomorrow’s health threats.”
  • “According to HHS, the clinical trials for universal influenza vaccines are scheduled to begin in 2026, with Food and Drug Administration (FDA) approval targeted for 2029. The intranasal BPL-1357 flu vaccine, currently in advanced trials, is also on track for FDA review by 2029.”  

• Per an HHS news release,
  • “The U.S. Department of Health and Human Services, through the Office of the Assistant Secretary for Health and Office of Population Affairs, released a comprehensive review, opens in a new tab of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria. This review, informed by an evidence-based medicine approach, reveals serious concerns about medical interventions, such as puberty blockers, cross-sex hormones, and surgeries, that attempt to transition children and adolescents away from their sex.
  • “The review highlights a growing body of evidence pointing to significant risks—including irreversible harms such as infertility—while finding very weak evidence of benefit. That weakness has been a consistent finding of systematic reviews of evidence around the world.
  • “The review also fills a gap in the medical literature and existing clinical practice reviews with regard to the ethical aspects of pediatric medical transition. HHS believes that medical ethics should be central in this debate.”

• The Internal Revenue Service announced
  • SECTION 2. 2026 INFLATION ADJUSTED ITEMS
    • “.01 Health Savings Account Inflation Adjusted Items.
      • “(1) Annual contribution limitation. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(A) for an individual with self-only coverage under a high– deductible health plan is $4,400. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(B) for an individual with family coverage under a high deductible health plan is $8,750.
      • “(2) High deductible health plan. For calendar year 2026, a “high deductible health plan” is defined under § 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,700 for self-only coverage or $3,400 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,500 for self-only coverage or $17,000 for family coverage.”

• OPM proposed a new rule
  • “The Office of Personnel Management (OPM) is proposing to remove the prohibition of a forced distribution of performance rating levels within the Senior Executive Service (SES) as well as eliminate diversity, equity, and inclusion (DEI) language within SES performance management regulations. Currently, agencies are prohibited from establishing quotas or limits on the number or proportion of the various rating levels assigned, meaning that each senior executive potentially can receive any rating based on their performance, irrespective of how other senior executives perform within the agency. However, governmentwide SES ratings data have consistently shown that virtually all SES receive the highest rating levels (i.e., levels 4 and 5) despite documented reports of SES failings. Removing the prohibition on forced distribution would allow agencies to establish and enforce limits on the highest SES rating levels, thereby increasing rigor in the SES appraisal process and leading to a more normalized distribution of SES ratings across the Federal Government.”
  • The FEHBlog estimates that the public comment period will end on June 2, 2025.

• Tammy Flanagan, writing in Govexec, provides “a crash course in retirement planning. Let’s revisit my tips and resources for transitioning from employee to annuitant.”

• Fierce Healthcare lets us know,
  • The Centers for Medicare & Medicaid Services (CMS) has launched the Fraud Detection Operation Center (FDOC) to fight waste, fraud and abuse, the agency announced this week.
  • Listed on a new webpage are a list of “recent success stories.” They include taking action against improper enrollment in Affordable Care Act (ACA) plans, cracking down on false billing of wound care services and scrutinizing “problematic activities” regarding hospice claims.
  • The page also claims it stopped payments to a provider who died 20 years ago as well removed 18 providers convicted of a “serious crime” for not meeting adequate standards.” ***
  • “The FDOC leverages the Fraud Prevention System (FPS), a system developed, built and operated by federal contractor Peraton. The FPS uses artificial intelligence and machine learning models to flag potentially fraudulent behavior by providers, allowing investigators to more easily see whether a provider should be funneled to the government’s case management system.”

From the Food and Drug Administration front,

• Fierce Pharma tells us,
  • “Amid a slew of recent shake-ups at the FDA—including the agency’s reduction in force and high-profile leadership exits—the regulator is ushering in “radical” changes to how it signs off on new vaccines.
  • “Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN. 
  • “It isn’t immediately clear which “new” vaccines will be affected by the policy. Flu and COVID-19 vaccine shots are updated annually to match the latest strains and variants, so manufacturers do indeed roll out new shots based on their existing platforms. For novel vaccines against completely new viral targets, placebo testing is a regular part of the R&D and regulatory review process.” * * *

• Per BioPharma Dive,
  • “The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines may face additional regulatory scrutiny under new agency leadership.
  • “Alongside first quarter earnings Thursday, the biotechnology company said a U.S. approval decision previously expected this year may now occur in 2026. Moderna filed for approval in 2024 based on a late-stage study showing the shot sparked immune responses against both viruses in adults 50 years of age or older. But the FDA has communicated that it will require Phase 3 flu efficacy data before issuing a clearance, Moderna said.”

From the judicial front,

• Healthcare Dive reports,
  • “The Department of Justice is accusing three of the largest health insurers in the U.S. of paying brokers kickbacks for enrolling seniors in their Medicare Advantage plans.
  • “CVS unit Aetna, Elevance and Humana paid brokers eHealth, GoHealth and SelectQuote hundreds of millions of dollars in return for signing people up for their MA coverage from 2016 to 2021 — regardless of the plans’ suitability for those members’ needs, according to the DOJ’s complaint filed Thursday.
  • “Spokespeople for Humana and CVS said the companies are reviewing the DOJ’s complaint and did not provide detailed comment for this story, though CVS said it disagrees with the allegations. Elevance did not respond to a request for comment.”

From the public health and medical research front,

• CBS News reports,
  • “Diabetes deaths in the U.S. have fallen to some of the lowest rates in years, according to new preliminary figures published by the Centers for Disease Control and Prevention, reversing a surge in mortality that was seen during the COVID-19 pandemic.
  • “There were 26.4 deaths per 100,000 people from diabetes, according to early death certificate data for the third quarter of 2024 published this month by the CDC’s National Center for Health Statistics. 
  • “Death rates from diabetes peaked in 2021, according to CDC figures, at 31.1 deaths per 100,000 people for that year. Diabetes was the eighth leading cause of death in 2021. The CDC says the link between COVID-19 and diabetes may be to blame for that increase. 
  • “Data show an increase in mortality rates for all people during the COVID-19 pandemic, and research shows that people with underlying conditions, including diabetes, are more likely to become very sick from COVID-19 and have a higher risk of hospitalization and death,” Christopher Holliday, head of the CDC’s Division of Diabetes Translation, told CBS News in a statement.
  • “Holliday added that research shows the pandemic may also have made it harder for Americans to properly manage the disease, ranging from interruptions to physical activity to disruptions to routine medical care diagnosing and treating the disease.”

• MedPage Today adds,
  • While the incidence of breast cancer in young women has been increasing over the last 20 years, breast cancer deaths in this age group fell significantly between 2010 and 2020, researchers found.
  • Among women ages 20 to 49, incidence-based mortality declined from 9.70 per 100,000 women in 2010 to 1.47 per 100,000 in 2020, reported Adetunji Toriola, MD, PhD, MPH, of the Siteman Cancer Center at the Washington University School of Medicine in St. Louis, at the American Association for Cancer Research annual meeting in Chicago.” * * *
  • “While breast cancer mortality declined for each racial/ethnic group, rates differed substantially between groups.
  • “Black women had the highest incidence-based mortality in 2010 (16.56 per 100,000), and while that rate declined significantly over the next decade, these women still had the highest incidence-based mortality rate in 2020 (3.41 per 100,000).
  • “White women had the lowest incidence-based mortality in 2010 (9.18 per 100,000) and 2020 (1.16 per 100,000).
  • “Moreover, 5-year relative survival rates by race/ethnic group showed that rates exceeded 88.7% for most groups, except for Black women (82.4%). That discrepancy was similar for 10-year relative survival rates.
  • “There were significant declines in mortality among women aged 20 to 49 with breast cancer,” Toriola said during a press briefing. “However, there are still opportunities for improvements, especially in relation to eliminating disparities in survival.”

• HCPLive informs us,
  • The burden of chronic kidney disease (CKD) attributable to physical inactivity increased significantly from 1990-2021, according to findings from a recent study
  • Leveraging data from the Global Burden of Disease (GBD) 2021, the study found that despite some regional declines in mortality rates, global CKD-related deaths and disability-adjusted life years (DALYs) have risen significantly, especially in low-sociodemographic index (SDI) regions, among older adults, and in females.¹
  • “In recent years, low physical activity has become a major risk factor for noncommunicable diseases, contributing to the increased incidence of various chronic conditions, including diabetes, cardiovascular diseases, and CKD,” ZhenYi Zhao, of the School of Competitive Sports at Beijing Sport University in China, and colleagues wrote.

• Per an NIH news release,
  • “The genes of male and female placentas have marked differences in how they are expressed, according to a study by researchers at the National Institutes of Health (NIH) and other institutions. These differences involve the presence or absence of tags on DNA known as methyl groups, which switch genes on or off without changing their structure. Understanding these DNA methylation patterns may inform future research on the higher risk for pregnancy complications involving male fetuses, such as stillbirth and prematurity, as well as later life health conditions that occur in adults who were born after a complicated pregnancy.”
    
• The New York Times reports,
  • The happiness curve is collapsing.
  • For decades, research showed that the way people experienced happiness across their lifetimes looked like a U-shaped curve. Happiness tended to be high when they were young, then dipped in midlife, only to rise again as they grew old.
  • But recent surveys suggest that young adults aren’t as happy as they used to be, and that U-shaped curve is starting to flatten.
  • This pattern has shown up yet again in a new study, one of a collection of papers published on Wednesday in the journal Nature Mental Health. They are the first publications based on the inaugural wave of data from the Global Flourishing Study, a collaboration between researchers at Harvard and Baylor University.” * * *
  • “The study participants had relatively low measures of flourishing on average until age 50, the study found. This was the case in a number of countries, including the United Kingdom, Brazil and Australia. But the difference between the younger and older adults was largest in the United States, the researchers said.
  • “It is a pretty stark picture,” said Tyler J. VanderWeele, the lead author of the study and director of Harvard’s Human Flourishing Program. The findings raise an important question, he said: “Are we sufficiently investing in the well-being of youth?”

• Healio relates,
  • “Individuals using e-cigarettes exclusively had a significantly elevated risk for COPD, whereas this was not found when assessing the risk for type 2 diabetes or heart failure, according to data published in Nicotine and Tobacco Research.
  • “For clinicians, these results offer helpful information about how e-cigarettes compare to regular cigarettes in terms of health risks,” John Erhabor, MD, MPH,research postdoctoral fellow at Johns Hopkins Medicine, told Healio. “While e-cigarettes may have fewer heart and metabolic risks than regular cigarettes, they are still tied to certain problems like COPD and possibly high blood pressure in some age groups.
  • “Doctors should take these differences into account when advising patients and make clear that switching completely from regular cigarettes to e-cigarettes may potentially lower health risks, but using both does not offer the same benefit,” Erhabor said.”

• The American Medical Association News points out,
  • “The Health Resources and Services Administration announced its toll-free number (1-833-TLC-MAMA) and promotional toolkit are available in advance of Maternal Mental Health Awareness Week, May 5-11. Since its launch on Mother’s Day 2022, the hotline has received more than 54,173 calls and texts from individuals seeking help for themselves (73%) or on behalf of someone else (4%). The hotline is available in English and Spanish and offers interpreters in more than 60 languages.”

• The U.S. Preventive Services Task Force released a final research plan for “Sexually Transmitted Infections: Behavioral Counseling.” The next step is a proposed recommendation.

• STAT New warns,
  • The era of “tranq” may be ending.
  • “But tranq, as the powerful veterinary tranquilizer xylazine is known in the illicit drug supply, is being replaced at least in part by a dangerous new sedative: medetomidine. In the past year, the anesthetic has become an increasingly common element in the drug supply, with cities and states including Philadelphia, Pittsburgh, Chicago, and San Francisco reporting cases of medetomidine-involved overdoses.
  • “In Philadelphia in particular, reports of medetomidine have skyrocketed. When the city first began testing for the substance in May 2024, it found medetomidine in 29% of fentanyl samples analyzed, according to data from the city’s public health department. Six months later, medetomidine’s prevalence had increased threefold to 87% — while xylazine’s dropped from 100% early in the year to 42% in November.”

• The CDC adds in a related report issued today,
  • Summary
  • What is already known about this topic?
    • Medetomidine is an increasingly common adulterant of illegally manufactured opioids.
  • What is added by this report?
    • During October 2024–March 2025, a total of 23 adult patients who used illegally manufactured opioids sought treatment within a health care system in Pittsburgh, Pennsylvania. All exhibited severe autonomic hyperactivity, and most required dexmedetomidine infusion and intensive care unit–level management. Medetomidine metabolites were detected in all 10 patients for whom retrospective analysis was performed, despite only two having detectable parent compound (medetomidine) on comprehensive urine drug screening.
  • What are the implications for public health practice?
    • Health care providers in regions where medetomidine has been detected in the drug supply should be prepared to manage a severe withdrawal syndrome among patients who use illegally manufactured opioids, even if drug testing for medetomidine is negative.

From the U.S. healthcare business front,

• Healthcare Dive reports,
  • “CVS Health’s insurance division Aetna will stop offering plans for individuals on the Affordable Care Act exchanges in 2026, after the company projected big losses in the business this year.
  • “The news was announced in tandem with CVS’ first quarter results, which exceeded investor expectations and represent a turnaround for CVS’ beleaguered insurance business, analysts said. The Rhode Island-based healthcare company reported net profit of $1.8 billion — up 60% year over year — on revenue of $94.6 billion.
  • “CVS’ pharmacy benefit manager Caremark also reached an agreement with Danish drugmaker Novo Nordisk to give its weight loss drug Wegovy preferred access on Caremark’s standard formulary, which covers tens of millions of Americans. The deal should increase access to Wegovy at the expense of other therapies, such as Eli Lilly’s Zepbound.”

• Fierce Pharma notes,
  • “Moderna is extending its cost savings program into 2027 and targeting a cash breakeven point sometime in 2028 as the larger U.S. vaccine market faces new uncertainties under the Trump administration.
  • “Moderna aims to reduce its GAAP operating costs by 1.4 billion to $1.7 billion between 2025 and 2027, the company announced Wednesday. The Massachusetts biotech now targets $4.7 billion to $5 billion in GAAP costs in 2027, versus $7.2 billion last year.
  • “On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its cash operating costs from about $6.3 billion in 2024 to about $5.5 billion this year, and then further to $4.7 billion and $4.2 billion in the two subsequent years.
  • “Compared with cash operating costs, GAAP costs also include stock-based compensation for executives and asset value depreciation.”

• The Leapfrog Group released its Spring 2025 hospital patient safety grades today.

• Beckers Hospital Review calls attention to the hospitals with straight A streaks from Leapfrog and those with straight F’s for Spring 2025.

• Per MedTech Dive,
  • “GE Healthcare cut its 2025 adjusted earnings outlook to reflect an estimated 85-cent-per-share impact from tariffs, especially duties affecting trade with China, executives said on an earnings call Wednesday.
  • “CEO Peter Arduini said bilateral U.S. and China tariffs account for 75% of the total net impact.
  • “For the full year, GE Healthcare now expects adjusted earnings in a range of $3.90 to $4.10 per share, down from the prior estimate of $4.61 to $4.75.
  • “The revised outlook assumes that tariffs remain at the current elevated levels and that U.S. reciprocal tariffs on the rest of the world — announced April 2 — return to pre-pause rates on July 9. The forecast also assumes Mexico and Canada tariffs remain in place, with exemptions under the U.S.-Mexico-Canada Agreement continuing for all eligible imports.”
• and
  • “Abbott has struck a deal to integrate data from its Libre continuous glucose monitors into Epic’s electronic health record systems in the U.S., the companies said Tuesday.
  • “The integration will connect Abbott’s data management software to Epic’s EHR systems. Linking the systems will allow clinicians to view glucose data captured by Libre devices within Epic. 
  • “The Epic integration could be the start of a broader Abbott initiative. Lisa Earnhardt, group president of medical devices for Abbott, said in a statement that the company aims to expand the integrated model to “other medical devices and connected care platforms in the future.”

• Modern Healthcare reports,
  • “Medical weighing and measuring technology company seca launched the first compact, portable body composition scanner designed for primary care on Thursday.
  • “The mBCA Alpha scanner generates a detailed assessment of a patient’s body composition in 24 seconds, which includes percentages of fat, bone and muscle. Clinicians can use the information to spot early signs of excess body fat, age-related muscle decline and the impact medications like GLP-1s can have on the body, among other factors.
  • “Primary care physicians typically rely on weight and body mass indexing to determine a patient’s risk of chronic conditions such as obesity, diabetes, heart disease and metabolic syndrome. But body mass index doesn’t reflect muscle mass or fat distribution, which can vary significantly depending on age, gender and race, according to Nina Crowley, director of clinical education and partnerships at seca.
  • “The American Medical Association issued a policy update in June 2023 that called out body mass index as an imperfect way of measuring body fat in some populations and recommended it be used in conjunction with other screenings including body composition.
  • “Other imaging modalities like MRI and dual-energy X-ray absorptiometry can also provide information about a patient’s body composition, but Alpha can do it at a fraction of the cost, according to Crowley.”