Monday update

Federal employment benefits

Monday update

David Ermer–CDC, CMS, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM) today issued new government-wide guidance to ensure that performance awards are meaningfully targeted to the highest-performing federal employees. The updated policy directs agencies to strengthen performance management practices, normalize ratings, and reserve the largest awards and bonuses for employees who have demonstrated exceptional contributions to their agencyʼs mission. The guidance also encourages agencies to expand use of non-cash awards, such as time-off and quality step increases, and to recognize real-time accomplishments throughout the year
  • Per an HHS news release,
    • “Health and Human Services Secretary Robert F. Kennedy, Jr. visited the CDC headquarters in Atlanta today in response to Friday’s tragic gunfire attack that claimed the life of DeKalb County Police Officer David Rose. 
    • “CDC security led Secretary Kennedy on a tour of the Roybal Campus, pointing out shattered windows across multiple buildings, including the main guard booth. Health and Human Services Deputy Secretary Jim O’Neill and CDC Director Susan Monarez accompanied him on the tour. 
    • “Secretary Kennedy visited the DeKalb County Police Department, where he met with Police Chief Greg Padrick. Later, he met privately with the widow of Officer David Rose, who courageously gave his life in the line of duty. He offered his deepest condolences and reaffirmed the agency’s commitment to honoring Officer Rose’s bravery, sacrifice, and service to the nation.” 

From the judicial front,

  • It occurred to the FEHBlog this afternoon that we recently passed the August 7 deadline for the parties to submit a joint status report to the federal court considering a challenge to the Biden Administration’s 2024 mental health parity rule amendments.  
    • It turns out that the status report (Dropbox link) was timely submitted on August 7.
    • The parties reported,
      • “The Departments continue to consider whether to issue a notice of proposed rulemaking to revise or rescind the 2024 Rule and to determine when it would be appropriate to add a MHPAEA regulatory action to the agencies’ Semiannual Regulatory Agenda.
      • “Pursuant to the Court’s May 12, 2025, Minute Order, the parties will file another joint status report on or before November 5, 2025, to report on Defendants’ progress.” 
    • The most recent semi-annual regulatory report appearing on reginfo.gov is Fall 2024 dated 12/13/2024.
  • Fierce Healthcare reports,
    • “Hospital and health system groups are skeptical the Trump administration will have enough time to weigh and incorporate providers’ concerns before opening its 340B rebate pilot program up to drugmaker applicants. 
    • “In a letter sent to the Health Resources and Services Administration (HRSA), which oversees the controversial subsidy program, seven provider associations requested HRSA extend the timeline for stakeholder comments and give itself a broader window to consider public comments. 
    • “Specifically, the current timeline outlined by HRSA in late July requires comments on the program to be submitted by Sept. 8, and for drugmakers to submit their applications and rebate plans by Sept. 15. Approvals would be made by Oct. 15, and the pilot is slated to begin at the top of the year 
    • “Instead, the associations have floated a Sept. 15 comment period, an Oct. 20 manufacturer application deadline and a Nov. 3 approval date.
    • “With the fundamental changes a rebate model will impose on all 340B stakeholders, it is impossible for the agency to meaningfully consider, in just seven days, all the feedback it will surely receive,” the associations wrote in their letter (PDF). “Moreover, drug companies have spent years developing and preparing for a rebate model, but the agency’s current timeline would give 340B hospitals far less time to prepare.”

From the public health and medical research,

  • The American Medical Association lets us know what doctors wish their patients knew about joint injuries and treatment.
  • Consumer Reports, writing in the Washington Post, discusses “how to get more out of physical therapy. It can reduce pain, boost strength, get you as healthy as possible for surgery and more.”
  • Medscape lets us know what doctors wish their patients knew about “How High-Fiber Diets and Supplements Can Improve Health for Patients With Obesity.”
  • Per MedPage Today,
    • “Previous research on associations between prediabetes and mortality has produced conflicting results.
    • “This study found that prediabetes was statistically significantly associated with mortality only among adults ages 20 to 54 years.
    • “Mortality risk in younger adults could be due to metabolic or behavioral risk factors.” * * *
    • “Elizabeth Selvin, PhD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, who was not involved in the study, told MedPage Today that the findings were “very consistent with [the 2019 study] demonstrating that prediabetes in older adults is not strongly associated with mortality.”
    • “Current definitions of prediabetes are very broad and they capture a lot of people who are not at high risk for poor outcomes, especially in old age,” she said. “In older ages, mild elevations in glucose are extraordinarily common and seem to reflect mild metabolic dysfunction corresponding with aging rather than severe hyperglycemia that leads to diabetes.”
  • BioPharma Dive reports,
    • “An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits on Monday. 
    • “IO Biotech, however, still believes the vaccine performed well enough to warrant a potential approval consideration from U.S. regulators. The company noted how the study, which compared a regimen of its shot and Merck & Co.’s immunotherapy Keytruda to Keytruda alone, failed by the slimmest of margins. Executives also pointed to other analyses showing potentially stronger benefits among those who hadn’t previously received drugs like Keytruda or aren’t likely to respond to them. 
    • “It was a very narrow miss, just by a hair,” said Mai-Britt Zocca, IO’s CEO, on a Monday conference call with Wall Street analysts.
    • “Called Cylembio, IO’s cancer vaccine consists of engineered peptides that are supposed to provoke an immune response to certain proteins expressed on tumor cells. Those proteins are two of the immune “checkpoints,” PD-L1 and IDO1, long studied by drugmakers.”
  • and
    • “An experimental Novartis drug has succeeded against a tough-to-treat autoimmune condition, boosting the outlook for a multibillion-dollar acquisition the Swiss pharmaceutical company made last year. 
    • “According to Novartis, the drug, called ianalumab, met its main goal in two Phase 3 studies in Sjögren’s syndrome, a chronic and progressive immune disease. Novartis didn’t provide specifics, but said Monday that treatment with ianalumab led to statistically significant improvements in disease activity compared to a placebo in each trial, as measured by a widely used index evaluating symptoms. The drug was also “well tolerated” and demonstrated “a favorable safety profile,” the company said in a statement. 
    • “Novartis will share the findings at an upcoming medical meeting and submit them to global health regulators.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente closed its second quarter of the year with a billion dollars of operating income and a $3.3 billion bottom line—but operating headwinds on the horizon have leadership taking a hard look at the health system’s cost structure and potential efficiencies.
    • “The quarter’s performance is a step ahead of last year, when the integrated nonprofit reported $908 million of operating income and $2.1 billion in net income.
    • “It’s also a fair jump in the scale of Kaiser’s operations. Consolidated operating revenues and expenses during the most recent quarter were $32.1 billion and $31.1 billion, respectively, up from $29.1 billion and $28.2 billion in the second quarter of 2024. These reflect a 3.2% operating margin in the second quarter of 2025 and a 3.1% operating margin in the second quarter of 2024.
    • “Together with the year’s opening quarter, Kaiser now sits at about $63.9 billion of operating revenue and nearly $2 billion of operating income for the first half of the year. Kaiser said its operating income runs highest during the beginning of the year due to the timing of its health plan’s open enrollment”
  • Healthcare Dive tells us,
    • “Major for-profit hospital chains reported lower-than-expected volumes in second quarter earnings results, causing some to cut back on volume and earnings expectations for the year.
    • “Executives at the for-profit hospital chains — HCA Healthcare, Tenet Healthcare, Community Health Systems and Universal Health Services — attributed the volumes to different factors, from lower Medicaid admissions to a decline in consumer confidence, which impacted spending on healthcare services. 
    • “Softer volumes caused HCA, Tenet and CHS to lower their full-year outlooks for admissions. UHS did not report expectations for volume growth.”
  • Here are links to Kaufmann Hall’s June 2025 flash reports on hospitals and physicians, both of which were released today.
  • Beckers Hospital Review points out CMS’s 290 five star and 229 one star hospitals.
    • “Every year, CMS assigns star ratings to U.S. hospitals based on 46 hospital quality measures, which are divided into five categories: mortality, safety, patient experience, readmission rates, and timely and effective care. Data reporting periods range from July 2020 to December 2024, depending on the measure. The ratings were updated in July and released Aug. 6.” “
  • The American Journal of Managed Care informs us,
    • “Prescribing semaglutide in routine clinical practice was associated with meaningful—but smaller than seen in clinical trials—improvements in cardiovascular risk factors, along with an unexpected rise in non-drug health care spending, according to a new study published in JAMA Network Open.1
    • “Analyzing data from more than 23,500 adult patients across Yale New Haven Health System and Sentara Healthcare, researchers found that patients experienced an average 3.8% reduction in body weight and significant reductions in blood pressure (–1.5 mm Hg for diastolic; –1.1 for systolic), total cholesterol (–12.8 mg/dL), and hemoglobin A1c (HbA1C) at 13 to 24 months following their first semaglutide prescription. However, during the same time period, monthly health care expenditures rose by $80 per patient, not including the cost of semaglutide itself.
    • “These findings highlight a disconnect between clinical benefits and short-term cost savings, warranting caution when extrapolating trial-based projections to clinical settings,” the researchers said.”

Midweek report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
  • Fedsmith lets us know,
    • “The summer of 2025 experienced an unusually high surge in incoming retirement claims, starting in May and continuing into June. This surge can be largely attributed to the significant number of federal employees who have left federal service through various programs, including deferred resignation, Voluntary Early Retirement Authority (VERA), and others.
    • “According to OPM, approximately 154,000 federal employees have resigned under the deferred resignation program, and OPM Director Scott Kupor said recently that he anticipates the total federal workforce reduction to be at least double that number in the near future.”
  • Per an OPM press release,
    • The U.S. Office of Personnel Management (OPM) today announced that registration is now open for its innovative Executive Development Programs, designed specifically for Senior Executives Service (SES), GS-15, and GS-14 leaders.
    • These programs are closely aligned with President Trumpʼs new Executive Core Qualifications (ECQs) for senior executives, ensuring participants develop the critical competencies needed for todayʼs federal leadership roles.
    • By focusing on these updated standards, OPM is empowering leaders to deliver meaningful results and advance the mission of government agencies nationwide, drive President Trumpʼs ambitious agenda, and improve performance and accountability across the federal government. The program is highlighted by training videos from key Trump Administration leaders and distinguished career Senior Executives.
  • The American Hospital Association News tells us,
    • “A new analysis published Aug. 6 by the Peterson Center on Healthcare and KFF found that Health Insurance Marketplace insurers will propose a median premium increase of 18% for 2026. A previous analysis reported 15% based on preliminary findings. The new findings were examined from individual market filings, which provide additional details and are publicly available. The proposal more than doubles last year’s 7% median proposed increase.
    • “Insurers are citing the increase on higher prescription drug costs as well as labor costs, inflation, the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The report found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase costs of certain drugs, medical equipment and supplies. Final rates will be determined in late summer.”
  • Bricker Graydon informs us,
    • “As employers increasingly struggle with rising health plan costs, the IRS has provided some good news.  Recently, the IRS announced that the Affordable Care Act (ACA) affordability threshold will increase to 9.96% of household income for plan years starting in 2026.  This is an increase from the 9.02% that applied to 2025.  This significant increase means employers have more room to potentially increase the employee portion of premiums for 2026. 
    • “The ACA affordability percentage is used to determine if ACA employer penalties may apply to employer-provided coverage. An employer’s health coverage will be considered affordable as long as the employee’s required contribution for the lowest-cost, self-only coverage does not exceed 9.96% of their income (or an IRS-approved safe harbor equivalent, such as the W-2, rate-of-pay, or federal poverty line methods). For example, under the federal poverty line safe harbor, monthly employee contributions will need to remain below approximately $129.89 in 2026.”

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP points out,
    • “Clarametyx Biosciences said this week that its investigational antibody treatment for cystic fibrosis patients plagued by chronic bacterial lung infections will receive priority review and development incentives from the US Food and Drug Administration (FDA).
    • “The company said in a press release that the FDA had granted CMTX-101, a monoclonal antibody designed to rapidly collapse bacterial biofilms, Fast Track and Qualified Infectious Disease Product (QIDP) designations under the Gaining Antibiotic Incentives Now Act. The two designations mean Ohio-based Clarametyx will get more frequent interactions with the agency, an expedited review process and potentially accelerated approval, and an additional 5 years of market exclusivity if CMTX-101 is approved.”
  • Cardiovascular Business reports,
    • “Boston Scientific’s Watchman device is associated with a heightened risk of air embolism events if the implant procedure is performed without positive pressure-controlled ventilation, according to the U.S. Food and Drug Administration (FDA). Air embolism is a rare, but potentially fatal complication that occurs when air enters the bloodstream and creates a blockage in a patient’s blood vessel. 
    • “According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk of negative left atrium pressure and air ingress,” according to a new FDA advisory. “This risk is especially prevalent in patients with preexisting low left atrial pressure, hypovolemia and partial upper airway collapse.”
    • “The FDA emphasized that air embolism can lead to “severe outcomes, including life-threatening or fatal consequences.” 
    • “Because of this risk, which has been associated with 120 serious injuries and 17 deaths as of July 30, Boston Scientific is updating the assembly instructions of several access systems used to implant the Watchman device in patients with nonvalvular atrial fibrillation.”
  • and 
    • “The U.S. Food and Drug Administration (FDA) is sharing additional details about a safety issue with certain Boston Scientific defibrillation leads. 
    • “According to the agency, some of the company’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) have been associated with a potential risk of rising low-voltage shock impedance (LVSI). This issue, linked to calcification, may make the devices less effective as time goes on.
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” according a new FDA advisory. “As of July 24, Boston Scientific has reported 386 serious injuries and 16 patient deaths associated with this issue.”
    • “The FDA is still reviewing the situation. At this time, the agency has not determined if this is a Class I recall. The goal of this early alert is to provide details as quickly as possible.” 

From the judicial front,

  • MedTech Dive relates,
    • “The Federal Trade Commission has moved to block Edwards Lifesciences’ planned acquisition of JenaValve Technology, citing concerns that the deal threatens to reduce competition in the market for devices to treat aortic regurgitation.
    • “The agency alleged that over two days in July 2024, Edwards signed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring transcatheter aortic valve replacement devices to market to treat the potentially fatal heart condition. Edwards closed the acquisition of JC Medical in August 2024.
    • “The FTC said Edwards’ proposed $945 million acquisition of JenaValve would combine the only two companies conducting U.S. clinical trials for a TAVR aortic regurgitation, or TAVR-AR, device.
    • “The deal threatens to reduce competition in the TAVR-AR market, likely resulting in reduced innovation, diminished product quality, and potentially increased prices for consumers,” the agency stated in a federal court complaint.
    • “The commission voted 3-0 to issue an administrative complaint and seek a temporary restraining order and a preliminary injunction to halt the transaction pending an administrative proceeding. The complaint and injunction request were filed in the U.S. District Court for the District of Columbia.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP relates,
    • “In a weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 23 more measles cases, bringing the national total for the year to 1,356 cases, the most since the United States achieved measles elimination in 2000.
    • “One more state reported cases, Wisconsin, lifting the number of affected states to 41. Three more outbreaks were reported, putting the nation’s total at 32 for the year. For comparison, the country had 16 outbreaks for all of 2024. 
    • “Of confirmed illnesses this year, 87% were part of outbreaks, compared with 69% for 2024. And of infected patients, 92% were unvaccinated or had unknown vaccination status. Though about 65% of cases occurred in children, 34% were recorded in adults ages 20 years and older.”
  • NBC News reports,
    • “A second person has now died and more than 50 people have fallen ill as part of a growing Legionnaires’ cluster in Harlem, city health officials reported Monday.
    • “The disease was initially detected on July 25; since then, two people have died and 58 people have been diagnosed, the New York City Health Department revealed in its latest update.
    • “Legionnaire’s, a type of pneumonia, is caused by the bacteria Legionella, which grows in warm water. The cases from the cluster have been found in five Harlem ZIP codes: 10027, 10030, 10035, 10037 and 10039, along with the bordering communities, according to health officials.
    • “If you’re in those ZIP codes that have demonstrated exposure, then we want you to monitor your symptoms and get to a healthcare provider as soon as you can so you can get access to antibiotics, because it is treatable,” said Dr. Tony Eyssallenne, the deputy chief medical officer for the city’s Health Department.”
  • STAT News notes,
    • “Hundreds of wildfires burning across the Canadian provinces of Manitoba and Saskatchewan are pushing smoke across Canada and the American northeast. Canadian towns close to the wildfires are experiencing the worst of the smoke pollution, but even here in Boston, there was a brief ground stop at the airport Monday due to smoke and haze. 
    • “It’s getting better, but here’s a reminder: 
      • “Wildfire smoke is particularly harmful to kids’ respiratory health. One study found that a 10-unit increase of fine particulate matter from wildfire smoke was associated with a 30% spike in pediatric admissions for respiratory problems. “It’s quite a big bit of a difference,” the lead author said.
      • “Researchers have found that people who live in areas with high levels of fine particulate matter could have a greater risk of developing dementia, with a particularly strong link seen between the condition and exposure to wildfire emissions. Still, there are a lot of questions remaining about other long-term effects.
      • “In California, between 2008 and 2010, somewhere between 52,480 and 55,710 people died prematurely due to chronic exposure to wildfire smoke. The economic impact of those deaths was at least $432 billion.”
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Aug. 5 announced a new campaign educating youth ages 12-17 on substance use, mental health and how they are connected. The campaign includes facts about drugs, including prescription medications, and how they can lead to addiction and other health problems. It also includes tips and resources to help improve mental health and recognize the link between mental health and substance use.”
  • The Washington Post reports,
    • “Seven years of investigation by scientists at Harvard Medical School has revealed that the loss of the metal lithium plays a powerful role in Alzheimer’s disease, a finding that could lead to earlier detection, new treatments and a broader understanding of how the brain ages.
    • “Researchers led by Bruce A. Yankner, a professor of genetics and neurology at Harvard Medical School, reported that they were able to reverse the disease in mice and restore brain function with small amounts of the compound lithium orotate, enough to mimic the metal’s natural level in the brain. Their study appeared Wednesday in the journal Nature.
    • “The obvious impact is that because lithium orotate is dirt cheap, hopefully we will get rigorous, randomized trials testing this very, very quickly,” said Matt Kaeberlein, former director of the Healthy Aging and Longevity Research Institute at the University of Washington, who did not participate in the study. “And I would say that it will be an embarrassment to the Alzheimer’s clinical community if that doesn’t happen right away.”
    • “Yankner, who is also the co-director of the Paul F. Glenn Center for Biology of Aging Research at Harvard, said: “I do not recommend that people take lithium at this point, because it has not been validated as a treatment in humans. We always have to be cautious because things can change as you go from mice to humans.” He added that the findings still need to be validated by other labs.”
  • Per MedPage Today,
    • “Most therapies for low back pain provide only short-term relief; it’s unclear, however, whether benefits from cognitive functional therapy (CFT) may last longer.
    • “Investigators in this study performed 3-year follow-up with participants in a 6-month trial of CFT versus usual care.
    • “Compared with usual care, patients receiving CFT either with or without biofeedback for 6 months continued to show more improvement after 3 years.”
  • Per Beckers Hospital Review,
    • “Healthcare experts are calling for the end of routine use of diphenhydramine, the active ingredient in a common allergy medication, sold as Benadryl, citing safety concerns that outweigh benefits, CNN reported Aug. 1. 
    • “It’s time to move on. For every single indication that people are using diphenhydramine, there are better drugs that are more effective at treating the symptoms people are trying to treat with fewer side effects,” said Anna Wolfsen, MD, an allergist at Massachusetts General Hospital in Boston. “I’ve had patients where I worried that diphenhydramine was impairing their ability to drive or fully participate in their daily lives.”
    • “The widely used, first-generation antihistamine is commonly used to treat allergies. However, other second-generation antihistamines, including brand names such as Claritin, Zyrtec and Allegra, offer the same or better relief with fewer side effects, experts told CNN.” 

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Hinge Health beat investor expectations on revenue in the digital musculoskeletal care company’s first public earnings results.
    • “Revenue increased 55% year over year to $139.1 million in the second quarter, the firm said in earnings released Tuesday. 
    • “The digital health company reported an operational loss of $580.7 million, compared with $17.6 million last year, driven by a stock-based compensation expense largely related to Hinge’s recent IPO, a spokesperson told Healthcare Dive.”
  • STAT News tells us,
    • “Exact Sciences announced on Wednesday that it acquired the rights to a blood-based colon cancer screening test from rival firm Freenome.
    • “Exact is paying Freenome $75 million for exclusive rights in the United States to current and future versions of the Bay Area company’s test, which is currently under review by the Food and Drug Administration. Freenome is eligible for up to $700 million in additional milestone payments.
    • “The deal ratchets up Exact’s intense competition with Guardant Health, which received FDA approval last year for its own blood-based colon cancer test.
    • “Exact had been developing its own blood-based colon cancer test. Last year, the company reported promising initial results from a study of more than 3,000 samples. But on Wednesday, the company disclosed that additional testing showed that the liquid biopsy test wasn’t quite accurate enough to win Medicare reimbursement. Instead, Exact will now look to market Freenome’s test to patients, pending approval.” 
  • Per Fierce Healthcare,
    • “Days after decreasing full-year guidance by about half a billion dollars, Oscar Health missed earnings projections for the second quarter.
    • “The insurer posted a higher-than-anticipated loss per share of 89 cents, according to estimates by FactSet, reported Sherwood News.
    • “Oscar also recorded a net loss of $228 million, one quarter after having a net profit of $275 million. The insurer saw quarterly revenues hit $2.86 billion and its medical loss ratio (MLR) climb to 91.1%.
    • “The stark jump from a MLR of 79% was due to an increase in market morbidity in the Affordable Care Act exchanges, leading to a net risk adjustment transfer accrual, CEO Mark Bertolini told investors.”
  • and
    • “Blue Shield of California is teaming up with Gemini Health to roll out a new member tool that offers greater transparency at the pharmacy counter.
    • “The tool, called Price Check My Rx, will be available in the insurer’s existing member app, allowing members to see in real time the out-of-pocket price for any new or refilled prescriptions submitted by their provider and covered under their pharmacy benefits.
    • “When the prescription is submitted electronically, the platform will send the member a push notification that prompts them to look at the pricing details and explore alternatives, including low-cost options, if they prefer. Jigar Shah, chief marketing and strategy officer for Blue Shield, told Fierce Healthcare that the tool fits within the payer’s broader goal of simplifying the patient experience.”
  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy sales jumped 67% in the second quarter, despite generic competition in the U.S. market.
    • “The company reduced its full-year guidance due to the impact of copycat versions of its diabetes and obesity drugs.
    • “Outgoing CEO Lars Fruergaard Jorgensen expressed confidence in future growth under incoming CEO Maziar Mike Doustdar.”
  • BioPharma Dive adds,
    • “Scientists at Nxera Pharma have worked for the past year to develop a pipeline of wholly owned obesity drug candidates that the Tokyo and Cambridge, U.K.-based pharmaceutical company unveiled Wednesday. Chief among the seven new programs is an oral GLP-1 agonist that Nxera says is based on “differentiated chemistry” and is distinct from a compound it discovered together with Pfizer under a research alliance. Coincidentally, Pfizer disclosed Tuesday it discontinued development of that compound, a decision Nxera said was made “due to a portfolio decision.” 
  • Per MedTech Dive,
    • “BD is investing more than $35 million to expand production of prefilled flush syringes at a facility in Columbus, Nebraska, the company said Monday.
    • “The investment will add around 50 jobs at the site and equip BD to make hundreds of millions of additional units a year to meet growing demand from U.S. hospitals and health systems.
    • “BD framed the spending as part of an ongoing commitment to its Posiflush line, which has seen it invest more than $80 million to expand production of the syringes over the past three years.”

Monday Report

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

From Washington, DC,

  • PhRMA points out “August is National Immunization Awareness Month (NIAM)—a timely reminder of vaccines’ vital role in protecting our health, especially as preventable disease outbreaks rise and kids head back to school.”
  • Per an HHS news release,
    • “Health and Human Services Secretary Robert F. Kennedy, Jr. and U.S. Food and Drug Administration Commissioner Dr. Marty Makary today joined Secretary of Agriculture Brooke L. Rollins to celebrate her signing of six new Supplemental Nutrition Assistance Program (SNAP) state waivers to advance the Trump Administration’s priority to Make America Healthy Again. Iowa Governor Kim Reynolds and West Virginia Governor Patrick Morrisey joined them on the MAHA Monday event on the National Mall.
    • “MAHA Monday marks the second day of the U.S. Department of Agriculture’s (USDA) Great American Farmers Market 2025, a weeklong celebration of food, family, and farming to showcase American agriculture as part of the Trump Administration’s events leading up to the 250th anniversary of America’s founding next year.
    • “The SNAP waivers for West Virginia, Florida, Colorado, Louisiana, Oklahoma, and Texas amend the statutory definition of food for purchase and end the subsidization of popular types of junk food beginning in 2026.”
  • The New York Times adds
    • “New research suggests that people can lose more weight by avoiding ultra processed foods, even those that are typically considered healthy.
    • “The study, published today in the journal Nature Medicine, is the largest and longest clinical trial yet to examine the effects of ultra processed foods on weight. Participants lost twice as much weight when they followed diets made up of minimally processed foods, like pasta, chicken, fruits and vegetables, as they did when they followed diets with ultra processed foods that met nutrition standards, such as ready-to-heat frozen meals, breakfast cereals, protein bars and shakes.”
  • The Washington Post reports,
    • “The White House does not plan to require health insurers to provide coverage for in vitro fertilization services, two people with knowledge of internal discussions said, even though the idea was one of President Donald Trump’s key campaign pledges.” * * *
    • “A senior administration official, who also spoke on the condition of anonymity to discuss internal talks, said that while expanding IVF access remains a “huge priority” for Trump, the president can’t legally make IVF an essential health benefit without Congress first approving legislation to do so. It is unclear whether the administration plans to ask lawmakers to take up a bill, but the two people said that forcing insurance companies to cover IVF is not currently on the table.”
  • Tammy Flanagan, writing in Govexec, explains “How federal employees can check if their retirement estimate is accurate. Estimating your post-retirement income isn’t just math, it’s about getting the right data, understanding your service credit and avoiding costly missteps.”

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • “The FDA approved aceclidine 1.44% ophthalmic solution (Vizz) for adults with presbyopia, or age-related blurred near vision, maker Lenz Therapeutics announced on Thursday [July 31].
    • It marks the first aceclidine-based solution to be approved for the condition, which affects an estimated 128 million Americans — almost half the adult population.
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of Philips Respironics V30, A30 and A40 ventilators due to the potential for serious injury or death. The company is updating use instructions due to the risk of failure in the ventilator inoperative alarm, which can cause therapy interruption or loss. The recall involves correcting the devices and does not call for removing them from where they are used or sold.” 
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA. Keveney most recently served as Acting General Counsel of HHS, where he led the Department’s legal team in advancing key administration priorities and ensuring rigorous legal standards across public health programs.” * * *
    • “Robert Foster, the Department’s Principal Deputy General Counsel, will assume the role of Acting General Counsel of HHS. He will remain FDA Chief Counsel for Food, Research, and Drugs. Foster has deep experience in administrative law and public health litigation and has been a trusted advisor to Secretary Robert F. Kennedy, Jr. on matters ranging from vaccine regulation to bioethics.
    • “President Trump earlier this year nominated Michael Stuart, a member of the West Virginia Senate and former United States Attorney for the Southern District of West Virginia, as General Counsel of HHS. The U.S. Senate Committee on Finance held his nomination hearing on July 31, 2025.”

From the public health and medical research front,

  • STAT News relates,
    • “The Gates Foundation said Monday that it would commit $2.5 billion through 2030 to support dozens of different approaches for improving women’s health, from new medicines to prevent maternal mortality to vaccines to curb infections that disproportionately affect women.
    • “The figure represents an increase of about a third in the foundation’s funding for women’s health and maternal health compared to the previous five years, and is a small illustration of the kinds of commitments that Bill Gates, the foundation’s chairman and founder, is making as he seeks to donate the vast majority of his $114 billion fortune before winding down the foundation over the next 20 years. It is the largest funding commitment the Gates Foundation has made in women’s health.”
  • The Wall Street Journal reports,
    • “People under age 50 have been appearing increasingly at doctors’ offices in the past few decades, complaining of blood in their stool, abdominal trouble or unexplained weight loss. The diagnosis: colorectal cancer. And by that time, it was often too late.
    • “But that paradigm is finally starting to shift, at least for patients in their 40s. 
    • “There has been a jump in people aged 45 to 49 getting screened for colorectal cancer, after recent medical guidelines lowered the screening age for those at average risk. As a result, the disease is being caught sooner, when it is more curable and the treatment is less grueling, according to new research from the American Cancer Society. 
    • “The recent screening recommendations designed to catch cases sooner appear to be working. 
    • “It’s thrilling to see this,” said Rebecca Siegel, an epidemiologist at the ACS and an author of the new research. “It means fewer deaths and higher quality of life for people who are diagnosed.” 
  • Per MedPage Today,
    • “Compared with untreated flu, oseltamivir [Tamiflu] treatment reduced the risk of serious neuropsychiatric events in children.
    • “Prescribing information for oseltamivir carries warnings about abnormal behavior in kids with flu based on case reports.
    • “Concerns about possible side effects may contribute to oseltamivir being underused in kids at high risk for flu complications.”
  • Diagnostic Imaging notes,
    • “Emerging research suggests that mammography may play a viable role in detecting pregnancy-related breast cancer (PABC), even among women with extremely dense breasts.
    • “For a retrospective study, recently published in Clinical Imaging, researchers reviewed mediolateral oblique and craniocaudal mammogram views for 167 women (mean age of 37) with newly diagnosed PABC as well as ultrasound imaging for 146 women in the cohort. The study authors noted use of different mammography techniques, including full-field digital mammography (78 patients) and digital breast tomosynthesis (DBT) (89 patients).
    • “The researchers also pointed out that 97.6 percent of the cohort had dense breasts with 77 percent having extremely dense breasts. Eighty-two percent of the women were lactating, and 18 percent of the cohort were pregnant.”
  • Per the AHA News,
    • “Nearly 57% of mothers did not attend a postpartum follow-up visit three to eight weeks after giving birth, according to a report published July 29 by Cedar Gate Technologies. The rate was higher for younger mothers, as nearly 61% of those aged 20-24 did not attend follow-up appointments. Cedar Gate analyzed a national database of millions of commercially insured patients from July 2022 to June 2023. Previous estimates from the American College of Obstetrics and Gynecology suggested nearly 40% of women did not attend postpartum visits.” 
  • The American Medical Association lets us know what doctors wish their patients knew about Huntington’s Disease.
  • Per Fierce Pharma,
    • “While the JAK inhibitor market for alopecia areata (AA) has grown increasingly crowded in recent years, Rinvoq’s clinical performance in the hair follicle-attacking autoimmune disease could earn AbbVie a prominent seat at the table.
    • “After 24 weeks of treatment, Rinvoq (upadacitinib) at two doses—15 mg and 30 mg—helped 44.6% and 54.3% of adult alopecia patients achieve 80% or more scalp hair coverage, respectively, in a phase 3 trial. That compared to just 3.4% of patients on placebo who achieved the same level of hair growth.
    • “Patients enrolled in the study entered at a baseline of roughly 16% scalp hair coverage, as determined by the severity of alopecia tool (SALT), AbbVie said in a July 30 press release.”
  • Radiology Business informs us,
    • “Medical imaging accounts for 4 of the 5 most prevalent low-value healthcare services among Medicare beneficiaries, according to new research published Friday. 
    • “Imaging for plantar fasciitis” was the most frequently delivered unnecessary exam, occurring nearly 84 times per 100 Medicare beneficiaries, experts write in JAMA Health Forum. Low-value imaging for headache (76/100), syncope (72/100) and lower back pain (39/100) also made the top five, with vertebroplasty and kyphoplasty at No. 4. 
    • “The findings are based on a review representing claims from over 3.7 million Medicare beneficiaries treated between 2018 and 2020. Altogether, the payment program spent approximately $484 million on 15 different low-value imaging services, a figure that balloons to nearly $584 million when factoring in beneficiaries’ out-of-pocket costs.  
    • “Findings of this cross-sectional study highlight that reforms aimed at reducing spending for low-value services are feasible to achieve billions in savings without compromising patient health,” David D. Kim, PhD, and A. Mark Fendrick, MD, with the universities of Chicago and Michigan, respectively, wrote Aug. 1.”

From the U.S. healthcare business front,

  • Beckers Payer Issues identifies seventeen underrated skills that payer leaders need and further reports,
    • “Bloomington, Minn.-based HealthPartners is launching Simplica NextGen Copay, a health plan with no deductible or coinsurance for in-network care.
    • “With the plan, beneficiaries will also see what they’ll pay upfront before scheduling, according to an Aug. 4 HealthPartners news release. Copay amounts for specific services at each hospital or clinic vary based on the quality and affordability of the care delivered.
    • “The plan is launching on Jan. 1, 2026, and will initially be available to large-group, self-insured employers in the Twin Cities metro and surrounding counties, according to the release.
    • “We developed Simplica in response to the growing demand for more predictable benefits,” HealthPartners president and CEO Andrea Walsh said in the release. “This plan gives members the cost clarity and ease they expect from their health plan and guides them in making informed decisions about where to get the care they need.”
  • Modern Healthcare reports,
    • “Brian Pieninck has been tapped as the next president and CEO of GuideWell and its insurer subsidiary Florida Blue, effective Oct. 1.
    • “Pieninck currently serves as president and CEO of CareFirst BlueCross BlueShield and is chair of the Blue Cross Blue Shield Association’s board of directors. He will succeed Pat Geraghty, who in March announced his plans to retire Dec. 31, after 14 years with the organization. 
    • “Pieninck joined nonprofit CareFirst, an independent licensee of the Blue Cross Blue Shield Association, in 2015 as executive vice president of the large group strategic business unit before becoming chief operating officer in 2017. In 2018, he was named president and CEO of the company. 
    • “Prior to CareFirst, he held multiple leadership roles during 19 years at Aetna.”
  • and
    • “Kelly Munson has been named the next president and CEO of Independence Health Group, effective Oct. 1.
    • “Munson, who currently serves as president and CEO of Independence Health subsidiary AmeriHealth Caritas, will succeed Gregory Deavens, who earlier this year announced his plans to retire. Deavens will remain at the company through December to support the leadership transition, according to a Monday news release. 
    • “In addition to her role at Independence Health Group, Munson will shift into an oversight position at AmeriHealth Caritas.” 
  • Beckers Hospital Review calls attention to six planned hospital reopenings and adds that
    • “St. Luke’s Des Peres Hospital in St. Louis officially closed Aug. 1, a spokesperson for the Chesterfield, Mo.-based health system told Becker’s.
    • “The decision follows years of declining patient volumes and mounting financial challenges that made continued operation of the 143-bed hospital as an acute care facility unsustainable.” 

Thursday report

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

From Washington, DC,

  • It’s worth noting that while the House of Representative has gone out of town for the August recess, the Senate will remain in session through next week.
  • The Wall Street Journal reports,
    • “Hospitals would be required to disclose how they make key decisions regarding extremely premature infants in a bill set to be introduced Thursday by Sen. Tom Cotton (R., Ark.).
    • “The legislation is in part prompted by a Wall Street Journal investigation last year that found mothers had been told no lifesaving measures were possible for their extremely premature infants, even though other hospitals nearby offered care for infants born at similar gestational ages.
    • “The Neonatal Care Transparency Act of 2025 would require hospitals to disclose publicly whether there is a minimal gestational age at which they offer active care for infants, rather than comfort measures before their death. While many hospitals require lifesaving measures to be given at 25 weeks’ gestational age or above, decisions on whether to attempt to save younger premature infants can vary by hospital or even doctor.”
  • Per Senate news releases,
    • “On Thursday, July 31, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on how to lower health costs and make health care more affordable for American patients.
      • “Title: Making Health Care Affordable: Solutions to Lower Costs and Empower Patients
      • “Date: Thursday, July 31, 2025
      • “Time: 10:00 AM ET/ 9:00 AM CT
      • “Location: 430 Dirksen Senate Office Building
      • “Click here to watch live”
  • and
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Thursday, July 31, 2025, at 10:00 AM ET to consider Bryan Switzer to be a Deputy United States Trade Representative (USTR), Gustav Chiarello III to be an Assistant Secretary of Health and Human Services (HHS), Michael Stuart to be General Counsel of HHS and Derek Theurer to be a Deputy Under Secretary of the Treasury.
      • “Title: Hearing to consider nominees for USTR, HHS and Treasury
      • “Witnesses: Bryan Switzer; Gustav Chiarello; Michael Stuart; Derek Theurer
      • “Date: Thursday, July 31, 2025
      • “Time: 10:00 AM ET
      • “Location: 215 Dirksen Senate Office Building
      • “Witness testimony, opening statements and a live video of the hearing will be available on www.finance.senate.gov.”
  • The Society for Human Resource Management tells us,
    • “The annual employee contribution limit for dependent care flexible spending accounts (FSAs) is increasing by 50% beginning next year, a change employers will want to communicate to employees as open enrollment season gears up. 
    • “The massive tax law that President Donald Trump signed July 4, known as the One Big Beautiful Bill Act, raises the limit for the pretax benefit account used to pay for eligible dependent care services to $7,500 for single individuals and married couples filing jointly, up from $5,000, and $3,750 for married couples filing separately, up from $2,500. The increase is effective beginning Jan. 1, 2026.
    • “Industry experts have been pushing for a higher contribution limit for years, calling the new increase long overdue. Although other limits, such as for health savings accounts and medical FSAs, are indexed for inflation and usually increase nominally each year, that’s not the case for dependent care FSAs. The current limits have been in place since 1986, except for a temporary increase during the pandemic.
    • “The increase is a “game changer for both working parents and businesses,” said Sara Redington, co-founder of The Best Place for Working Parents (BP4WP), a Fort Worth, Texas-based organization that recognizes employers supporting working parents.”
  • Tammy Flanagan, writing in Govexec, discusses “Why federal retirements are spiking this year. A sharp rise in retirement claims may be tied to fear instead of planning. If you’re eyeing the exit, make sure you’re not rushing into something you’ll regret.”
  • Per STAT News,
    • “Everyone agrees that diet is important to good health. And yet fewer than a third of medical students receive the recommended minimum of 25 hours of nutrition education, and more than half report receiving no formal education on the topic at all. 
    • “That’s why health secretary Robert F. Kennedy Jr. may be pushing on an open door with his plans to require medical schools to include nutrition education in their curricula or else lose federal funding. 
    • “One of the things we’re gonna do at NIH is to really give a carrot and stick to medical schools across the country saying you gotta put in your first-year curriculum a really good, robust nutrition course,” he said in a video posted to his Instagram account earlier this month. 
    • “Medical experts who spoke with STAT noted that there is no standardized curriculum for nutrition, and that it’s not yet clear what specifics Kennedy may attach to funding or what training medical schools might have to cut back to make room for nutrition courses. But they were on board with Kennedy’s general goal, noting that many nutrition and food policy experts have been calling for this kind of change for years. A 2022 House of Representatives resolution on the need for better nutrition education also won bipartisan support. And some medical schools have already taken steps to strengthen their offerings on the subject.”

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “Although Sarepta Therapeutics managed to defuse a brief stalemate with the FDA earlier this week, the U.S. drug regulator is reportedly going to put the company to work in order to affirm the safety of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys.
    • “Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News reported Thursday, citing an unnamed senior FDA official.
    • “It’s unclear what sorts of studies Sarepta would need to run to get Elevidys back in the agency’s good graces, or whether the company might need to conduct a new clinical trial, Endpoints noted. The publication said it was unable to independently verify the internal FDA discussions alluded to by the official.
    • “That said, no one at the FDA thinks the treatment should return to market based on current data, an anonymous FDA official told Bloomberg.”
  • and
    • “Danish dermatology specialist Leo Pharma has scored an FDA approval that makes its JAK inhibitor cream Anzupgo (delgocitinib) the first therapeutic in the U.S. specifically indicated for chronic hand eczema (CHE).
    • “The endorsement covers adults with moderate to severe CHE for whom topical corticosteroids either have been inadequate or are not suitable. In September of last year, Anzpugo became the first topical treatment for the condition approved in Europe.
    • “Dermatologists hailed the approval as a long-awaited treatment option for a condition that is often overlooked despite it affecting 1 in 10 adults in the world. A recent study commissioned by Leo and conducted by Ipsos showed that more than half of nearly 200 dermatologists who were surveyed were frustrated by the lack of progress in the indication.
    • “They said current therapeutics for moderate to severe atopic dermatitis—which are often prescribed to treat CHE—don’t sufficiently translate as treatments for moderate to severe CHE.”
  • The American Hospital Association News lets us know,
    • “The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula devices due to the potential for serious injury or death. Edwards identified incidents in which a 3mm to 4mm section of wire from the wire-reinforcement coil at the cannula tip was found to be exposed. The FDA said that some Femoral Arterial Cannula models are made of the same components as the OptiSite Arterial Perfusion Cannula models. Edwards has called for both products to be removed from wherever they are used or sold.”
  • Modern Healthcare reports,
    • “The Food and Drug Administration has classified Baxter’s recall of its Q-Link 13 mobile lift component as the most serious type, meaning it could lead to critical injuries or death if customers continue to use it.
    • “The Q-Link 13 is used with seven models of the company’s mobile lifts, which are used to move patients with limited mobility from one location to another or help with gait training.
    • “It’s an optional part that can be connected with a quick-release hook for sling bars, which hold the lifting sling. It could be attached incorrectly, possibly causing it to come loose and lead to a patient fall. This could result in serious injury to the patient or a caregiver trying to prevent the fall.
    • “This issue has potentially been associated with three serious injuries and one death, according to Baxter.”

From the judicial front,

  • The Northwest Arkansas Democrat Gazette reports,
    • “A federal judge on Wednesday said he will try to issue a ruling soon on whether a new state law banning pharmacies operated by out-of-state pharmacy benefit managers should be enjoined while the matter is being litigated in court.”
  • Govexec tells us,
    • “The Trump administration revealed to a federal court on Thursday the specific offices at which widespread layoffs were planned as of earlier this year, providing rare insight into the scale of its proposed reductions in force.” * * *
    • “The administration revealed the requests to the U.S. Court for the Northern District of California after Judge Susan Illston ordered their disclosure. Illston previously blocked the administration from moving forward with RIFs at all, but that injunction was overturned by the Supreme Court. The judge is now seeking to verify the legality of RIF plans on an agency-by-agency basis and sought information from 17 agencies the administration had told the Supreme Court were set to begin layoffs when Illston’s injunction took effect. 
    • “The Trump administration said the list in some cases undercounted the number of offices developing RIF plans and in others overcounted and has consistently maintained its plans were moving targets. An appeals court this week blocked another order from Illston requiring the administration to disclose to the court reorganization and RIF plans at every major agency, though those were not yet set to be made public.”  

From the public health and medical research front,

  • The AP reports,
    • “The fertility rate in the U.S. dropped to an all-time low in 2024 with less than 1.6 kids per woman, new federal data released Thursday shows.
    • “The U.S. was once among only a few developed countries with a rate that ensured each generation had enough children to replace itself — about 2.1 kids per woman. But it has been sliding in America for close to two decades as more women are waiting longer to have children or never taking that step at all. 
    • “The new statistic is on par with fertility rates in western European countries, according to World Bank data.
    • “Alarmed by recent drops, the Trump administration has taken steps to increase falling birth rates, like issuing an executive order meant to expand access to and reduce costs of in vitro fertilization and backing the idea of “baby bonuses” that might encourage more couples to have kids.
    • “But there’s no reason to be alarmed, according to Leslie Root, a University of Colorado Boulder researcher focused on fertility and population policy. 
    • “We’re seeing this as part of an ongoing process of fertility delay. We know that the U.S. population is still growing, and we still have a natural increase — more births than deaths,” she said.”
  • The Hill tells us,
    • “A new study suggests diets including eggs, especially the yolk, may help reduce the risk of Alzheimer’s disease.
    • “Published in The Journal of Nutrition, the study followed more than 1,000 U.S. adults and found that those who consumed more than one egg weekly had a 47 percent reduced risk of Alzheimer’s.
    • “Over an average follow-up of 6.7 years, 280 participants, or 27.3 percent, were diagnosed with Alzheimer’s dementia. Researchers found that 39 percent of the “total effect of egg intake” was linked to choline, a nutrient found in egg yolks known to support memory and brain function.
    • “Egg yolks also contain omega-3 fatty acids, which have neuroprotective benefits, further supporting brain health.”
  • The New York Times relates,
    • “Tens of millions of people in the United States struggle with obstructive sleep apnea, a condition that occurs when the throat muscles narrow during sleep, leading to temporary pauses in breathing that can cause people to snore and jolt awake, gasping for air.
    • “Poor sleep can leave people feeling exhausted, irritable and unfocused during the day. And if left untreated, sleep apnea can increase the risk for serious conditions like high blood pressure, Type 2 diabetes, heart attack and stroke.
    • “For decades, the primary treatment for sleep apnea has been continuous positive airway pressure (or CPAP). Before bed, those with the condition put on a face mask that is connected to a CPAP machine, which keeps the airway open by forcing air into it. The machines are effective, but many find them so noisy, cumbersome or uncomfortable that they end up abandoning them.
    • “Now, a more appealing option may be on the way, according to a news release from Apnimed, a pharmaceutical company focused on treating sleep apnea. On Wednesday, the company announced a second round of positive Phase 3 clinical trial results for a first-of-its-kind oral pill that can be taken just before bedtime to help keep a person’s airway open.” * * *
    • “Dr. Phyllis Zee, a sleep doctor and researcher at Northwestern Medicine who was not involved with the trial, said that if approved, the drug could transform the lives of many. That includes not only those who can’t tolerate CPAP machines, but also those who can’t — or prefer not to — use other interventions, such as other types of oral devices or weight loss medications. (Excess weight is a risk factor for sleep apnea.)”
  • Per STAT News,
    • “A Phase 3 study of AstraZeneca’s gefurulimab hit its primary and all secondary endpoints, teeing up talks with regulators about the potential blockbuster treatment for generalized myasthenia gravis, Fierce Biotech writes. AstraZeneca’s high hopes for the drug rest on the belief that the weekly, self-administered medicine can unlock an earlier, broader population than its existing gMG drug Ultomiris. In the study, people on gefurulimab performed significantly better on a gMG scale that assesses the ability to perform daily activities versus those on placebo, achieving the primary endpoint of the study.”
  • The U.S. Preventive Services Task Force released its Final Research Plan for Vision in Children Ages 6 Months to 5 Years: Screening.
  • Aunt Minnie adds,
    • “Changing national lung cancer screening guidelines in 2021 may have contributed to a surge in screening exams, but less lung cancer was detected in newly screened participants, and racial, ethnic, and sexual disparities persisted overall, according to a study published July 21 in the Journal of Thoracic Imaging.
    • “While numerous studies have examined the effects of the U.S. Preventive Services Task Force (USPSTF)’s 2021 lung cancer screening (LCS) guidelines on eligibility, this study focused on participation and lung cancer outcomes over the first 10 years of implementing an LCS program.” * * *
    • “Simply revising the guidelines increases eligibility but does not guarantee participation in LCS for these populations,” Lin and colleagues wrote. “These findings underscore the need for continued emphasis on active outreach and patient education efforts to promote LCS among racial and ethnic minority groups, as well as the further evaluation of how these initiatives impact participation and outcomes.”

From the U.S. healthcare business front,

  • Yahoo Finance lets us know,
    •  “Independence Blue Cross (IBX) is helping to improve recovery outcomes for its Medicare Advantage members after they leave the hospital and reduce costs with its Post-Acute Care Program. The program combines predictive analytics, proactive case management, and a focus on home-based recovery, to ensure members receive the right care at the right time after a stay at the hospital. Since its launch in July 2022, it has helped to improve CAHPS survey scores—a tool used to measure members’ experiences with health care services and strengthen health care in the U.S. It has also delivered $13 million in cost savings and earned the prestigious Blue Cross Blue Shield Association’s (BCBSA) North Star Award for its measurable impact.”
  • Per Beckers Payer Issues,
    • “Priority Health, the insurance arm of Grand Rapids, Mich. based Corewell Health, will become the governing member of Group Health Cooperative of Eau Claire, a Wisconsin-based health plan with more than 61,000 members.
    • “Both organizations expect the transaction to close by the end of 2025, pending regulatory approvals.
    • “The agreement will make Priority Health a four-state health plan with more than 1.3 million members across Michigan, Indiana, Ohio and Wisconsin.”
  • Per the AHA News,
    • “The AHA July 24 announced it is collaborating with health care technology leader Epic to help hospitals adopt tools that support the early detection and treatment of postpartum hemorrhage, a leading cause of maternal mortality. 
    • “The organizations have released a toolkit that includes dynamic risk assessments, clinical decision support and treatment guidance embedded in the electronic health record. With the proper permissions from applicable content providers, users of any EHR should be able to implement a similar set of tools. 
    • “The American Hospital Association and Epic share a deep commitment to improving health outcomes for moms and babies,” said Chris DeRienzo, M.D., AHA chief physician executive and a neonatologist. “This new collaboration amplifies our efforts to drive continuous improvement by sharing evidence-based resources to help reduce this tragic condition. It’s a natural extension of AHA’s Patient Safety Initiative, a collaborative data-driven effort to highlight and learn from patient safety progress at hospitals and health systems around the country.” 
    • “The AHA and Epic will support hospitals in their implementation journey with programming, resources and a space to learn from each other and engage with hospitals already seeing successful outcomes with items that are included in the toolkit.”
  • Healthcare Dive informs us,
    • “Labcorp has agreed to acquire certain ambulatory outreach laboratory assets from Community Health Systems, furthering an expansion push that has seen the testing services provider forge deals with a growing list of local and national health systems.
    • “The $195 million cash agreement with CHS includes patient service centers and in-office phlebotomy locations in 13 states, where Labcorp will assume some facility leases.
    • “Evercore ISI analyst Elizabeth Anderson, in a note to clients Tuesday, called the deal “very much in-line with [Labcorp’s] long-stated hospital management and outreach strategy where it continues to build a strong track record.”

Thursday report

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

From Washington, DC

  • Per a Congressional press release,
    • “Congressman Raja Krishnamoorthi (D-IL) and Congresswoman Diana Harshbarger (R-TN) introduced [on July 15, 2025] the Fair Pharmacies for Federal Employees Act, legislation to protect federal employees and retirees from anti-competitive practices by pharmacy benefit managers (PBMs) and insurers. Under the bill, the Office of Personnel Management (OPM) is prohibited from contracting with entities in the Federal Employee Health Benefits Program (FEHBP) that both manage prescription drug benefits and own or control a pharmacy. The federal government administers and oversees the largest employer-based health care system in the country. By implementing comprehensive reform at the federal level, a proven model will be created that will lower health care costs across the board beyond the federal workforce and reach millions of Americans impacted by anti-competitive practices used by PBMs.” * * *
    • “The full text of the legislation is available here.”
  • This proposal would be very disruptive to the FEHB Program’s prescription drug benefits. Indeed, the FEHB Program’s prescription drug benefits would benefit from deregulation. 
  • Federal News Network reports,
    • “Employee departures at the Office of Personnel Management are contributing to the agency’s ongoing challenges with addressing fraud risks in the Federal Employees Health Benefits program.
    • “A new report from the Government Accountability Office dug into whether OPM had considered assessing various factors that create risks for fraud in the government’s health insurance program for federal employees. But partially due to recent staffing vacancies, OPM was unable to provide a clear answer.
    • “OPM officials “could not explain or provide documentation as to whether these inherent risks were considered as part of the assessment process, and why the resulting fraud risk profile does not address these risks,” GAO wrote on Thursday.
    • “Amid the overhauls that have taken place in OPM’s internal workforce over the last several months, agency officials who were previously responsible for conducting fraud risk assessments have left their jobs, according to GAO’s report.”
  • FEHB carriers, which hold the insurance risk, bear the laboring oar on fraud risk assessments. Carriers work closely with the Office of Inspector General.
  • STAT News informs us,
    • “The Trump administration is opening the floodgates for more surgeries to be done in outpatient facilities like ambulatory surgery centers, proposing a Medicare policy that could accelerate the shift away from hospital-based care. 
    • “The administration is aiming to scrap Medicare’s list of 1,700 procedures that the program will only pay for in inpatient settings. Medicare officials unveiled their decision to eliminate the so-called inpatient only list in a proposed rule on Tuesday, reprising an effort from the first Trump administration. 
    • “The agency had already removed common surgeries like hip and knee replacements from the list in recent years, but it said that getting rid of it entirely will give patients more choices and allow doctors to use their professional judgment to decide where procedures should take place. 
    • “Doctors, for their part, raised a number of concerns with the change, noting that it could jeopardize insurance coverage for inpatient surgeries and raise out-of-pocket costs for patients. But far and away their main issue with eliminating the list was the potential to endanger patients if the shift happens too quickly and with the wrong patients.
    • “I wouldn’t say that most doctors are going to be cowboys about it, but they may be working in health systems where they say, ‘Hey we want to get x-percent of these procedures done in the outpatient setting,’” said Andrew Ibrahim, an associate professor of surgery at the University of Michigan. “There may be nudges from their health system or the way their practice is set up.” 
  • The Washington Post reports,
    • “Partnerships between telehealth companies and pharmaceutical giants Pfizer and Eli Lilly raise concerns about conflicts of interest and inappropriate prescribing, according to a Senate investigation released Thursday.
    • “The report by offices of several Democratic senators said the arrangements appear intended to steer patients to medications manufactured by those companies, which maintain websites touting drugs and providing links directing them to doctors who can prescribe them.
    • “Such partnerships undermine the independent medical judgment of doctors, who may default to prescribing medications first instead of exploring other options and potentially “glossing over the comprehensive evaluation necessary for high-quality patient care,” concluded the report from the offices of Sens. Dick Durbin (D-Illinois), Bernie Sanders (I-Vermont), Elizabeth Warren (D-Massachusetts) and Peter Welch (D-Vermont).
    • “In statements, Eli Lilly and Pfizer said their online portals are meant to make it easier for patients to navigate health care and they do not pressure clinicians to prescribe their drugs.”
  • Per a CMS press release,
    • “The Centers for Medicare & Medicaid Services (CMS) continue to crush fraud, waste, and abuse in America’s healthcare programs by stopping duplicative enrollment in government health programs, with the potential to save taxpayers approximately $14 billion annually.
    • “A recent analysis of 2024 enrollment data identified 2.8 million Americans either enrolled in Medicaid or the Children’s Health Insurance Program (CHIP) in multiple states or simultaneously enrolled in both Medicaid/CHIP and a subsidized Affordable Care Act (ACA) Exchange plan. 
    • “CMS is taking action to ensure individuals are only enrolled in one program and to stop the federal government from paying multiple times for these individuals to receive health coverage. In addition, as a result of the One Big Beautiful Bill Act, CMS now has new tools to prevent the federal government from paying twice for the same person’s care—saving billions and restoring integrity to the system.”
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services July 17 issued two letters to states regarding policies on continuous eligibility and workforce initiatives. The agency said it does not anticipate approving new or extending existing section 1115 demonstration authorities, which expand continuous eligibility. Additionally, CMS said it does not anticipate approving new or extending existing Medicaid-funded workforce initiatives for training or employment-related activities.”
  • Govexec tells us,
    • “In his first public memo since his Senate confirmation last week, Office of Personnel Management Director Scott Kupor wrote that due to the 2023 Supreme Court case Groff v. DeJoy, which held that employers must demonstrate “substantial increased costs” if they deny an employee’s religious accommodation request, federal agencies should work to honor such requests from their employees.
    • “Agencies are encouraged to adopt a generous approach to approving religious accommodations, prioritizing employee needs while maintaining operational efficiency,” Kupor wrote. “Further, federal agencies must adhere to the requirements of Title VII [of the 1964 Civil Rights Act] and the Groff clarification of the ‘undue hardship’ standard when addressing religious accommodation requests.”
    • “Agencies may use a number of workplace flexibilities to address an employee’s religious accommodation request, including telework, compensatory time off, flexible and maxiflex work schedule, and both paid and unpaid leave. Telework in particular can be useful to accommodate observing—or preparing to observe—a religious holiday or sabbath observance, to engage in religious fasting or other time-specific prayer observances.”
  • Tammy Flanagan, writing in Govexec, lets us know that “OPM’s digital retirement application is live. What that means for feds planning to retire. The new electronic retirement system promises a faster, more accurate process, but some users are still adjusting to the change.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “In a surprise, advisers to the Food and Drug Administration on Thursday voted that the risks tied to a blood cancer drug from GSK outweighed the benefits it had demonstrated in trials, as concerns about sometimes serious eye-related side effects and questions about the dose the company selected dominated a hearing.
    • “The FDA is set to decide whether to approve the drug, called Blenrep, by as soon as next week. The agency often follows its advisers’ recommendations but does not have to.”
  • The AHA News relates,
    • “The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium. The FDA said the inadvertent administration of cefazolin following a recommended dosage of penicillin G potassium could pose serious and potentially life-threatening health consequences. Sandoz has not received any reports of adverse events or injuries related to the mislabeling but has received a complaint of the mislabeled product being administered to a patient.” 
  • Per MedTech Dive,
    • “Integra Lifesciences has recalled cranial drills over a defect linked to 10 injuries, the Food and Drug Administration said Wednesday.
    • “The company has asked customers to return Codman cranial perforators because they may break apart during use, causing the device to become lodged in the patient’s skull or injure the brain.
    • “Integra began the recall months after the FDA sent a warning letter to three facilities that make products including cranial perforators.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “A new lawsuit brought by 20 Democratic attorneys general says a recent final rule by the Centers for Medicare & Medicaid Services (CMS) will make it unfairly difficult to obtain health insurance through the Affordable Care Act (ACA).
    • “The lawsuit mirrors a challenge by three cities and liberal advocacy groups earlier this month. Plaintiffs in both cases say the regulation will cause up to 1.8 million people to lose coverage, starting in 2026. Many more will see premiums increase and out-of-pocket costs soar.
    • “Thursday’s suit (PDF) also takes issue with a provision in the rule, finalized in June, barring federal funds toward gender-affirming care services as an essential health benefit under the ACA.
    • “The states hope to delay the rule from taking effect in August.”

From the public health and medical research front,

  • The AP reports,
    • “Health officials in Illinois and North Dakota say their states’ measles outbreaks are over, pointing to a continuing slowdown of measles spread in the U.S. during vaccine-preventable disease’s worst year since 1991.
    • “Wednesday’s national case count stood at 1,309 — 21 new cases in a week, according to the U.S. Centers for Disease Control and Prevention. Last week, the U.S. passed the total count for 2019, when the country almost lost its status of having eliminated measles. 
    • “A vast majority of this year’s cases are from Texas, where a major outbreak raged through the late winter and spring. Other states with active outbreaks — which the CDC defines as three or more related cases — include Arizona, Colorado, Georgia, Iowa, Kansas, Kentucky, Michigan, Missouri, Montana, New Mexico, Oklahoma and Utah. 
    • “There have been three deaths in the U.S. this year, and all were unvaccinated: two elementary school-aged children in West Texas and an adult in New Mexico.”
  • The Washington Post relates, “Flesh-eating bacteria has killed 4 in Florida. Here’s what to know. Four people in Florida have died this year after contracting Vibrio vulnificus. Though rare, infections can require intensive care or limb amputation.”
  • The International Foundation of Employee Benefit Plans offers detailed advice on how to improve GI health in the workforce.
  • The National Science Foundation points out “AI that delivers smarter glucose predictions without compromising privacy.”
  • Per MedCity News,
    • “Over the past decade, employer-sponsored healthcare has undergone a significant transformation. Mental health solutions are finally mainstream. Fertility benefits are expanding. Women’s health has received overdue attention and innovation. Yet amid this evolution, one critical area remains largely ignored: men’s health.
    • “More than 88% of working-age men have unmet preventive, reproductive, and hormonal health needs. Despite making up half the workforce, men are falling through the cracks of today’s benefits strategies, often suffering in silence, delaying care, and showing up at the doctor’s only when it’s too late.
    • “For employers, this is more than a missed opportunity. It’s a growing liability financially, operationally, and culturally. Men’s health must be redefined not just as a clinical issue, but as a strategic business lever.”
  • Per STAT News,
    • “After a decade-long rise in suicide rates among young Americans — and with depression diagnoses soaring in this age group during the pandemic — the U.S. surgeon general issued a report in 2021 warning about the “devastating” state of youth mental health. The American Psychological Association declared it a “crisis.”It was part of a prolonged advocacy campaign to raise awareness about the problem and possible solutions, and finally, in 2022 and 2023, there were signs of success: Suicide rates for teens and young adults began to fall.
    • “Meanwhile, another demographic has gone largely overlooked. The people most at risk from suicide aren’t those in crisis in adolescence or midlife, but men age 75 and older. Some 38.2 deaths per 100,000 among men age 75 to 84 are by suicide, which increases to 55.7 among those over 85, according to data from CDC — more than 16 times the suicide rate for women in the same age group. Researchers are calling for a public health effort, much like the one to treat youth mental health, to help address suicide in older men.”
  • and
    • “Expert guidelines that clinicians across the country use to assess the risk of preeclampsia in pregnant women may be ineffective.
    • “The recommendations designed by the U.S. Preventive Services Task Force do not accurately predict risk of developing the condition and lead to nonspecific treatment guidance for the majority of patients, researchers found in a study published Thursday in JAMA Network Open. The findings have implications for reforming risk guidelines and increasing personalized care.
    • “This is a valuable, descriptive study,” Molly McAdow, a maternal-fetal medicine specialist at Yale New Haven Hospital, said. “There is certainly an opportunity for us to do better with a more stringent screening test.”
  • Per Health Day,
    • “Doctors might be overlooking a common cause of high blood pressure.
    • “New guidelines recommend screening for primary aldosteronism.
    • “Too much of the hormone aldosterone causes low potassium and high sodium, leading to high blood pressure.”
  • and
    • “Bedtime dosing with antihypertensive medication yields better nocturnal blood pressure control and improved circadian rhythm, according to a study published online July 9 in JAMA Network Open.”
  • Beckers Hospital Review relates,
    • “Pfizer is warning physicians that it expects a new shortage of Bicillin L-A, a long-acting penicillin injection that is currently the single recommended treatment for syphilis during pregnancy, CNN reported July 16. 
    • “The drugmaker’s alert follows a July 10 recall of certain lots found to contain floating particles, which Pfizer traced to faulty stoppers from an outside vendor. The company said no adverse reactions have yet been reported. 
    • “We have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,” the company said in a statement to the news outlet. “We fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Elevance on Thursday became the fourth major health insurer to lower or scrap its profit forecast, and executives warned things are going to get worse for the embattled sector before they get better. 
    • “Like its peers, Elevance said its members are getting a lot more care than the company had projected. For Elevance, the uptick is more pronounced in its Affordable Care Act business, but it’s also happening in Medicaid. The company lowered its full-year profit outlook by 13% to account for the higher costs, which are also baked into the plans it’ll sell in 2026. 
    • “We recognize that revising guidance for the second consecutive year is disappointing,” Gail Boudreaux, Elevance’s CEO, said on the company’s earnings call. “We remain committed to transparency and strong execution as we continue to navigate unprecedented cost trends affecting multiple lines of business.” 
  • Modern Healthcare lets us know,
    • “Group healthcare costs are expected to increase by 8.5% in 2026.
    • “PricewaterhouseCoopers’ Health Research Institute based its forecast published Thursday on policy changes, expensive medications including glucagon-like peptide agonists, higher rates of behavioral health claims and increased use of artificial intelligence, among other factors.
    • “For PwC’s annual report, researchers spoke with actuaries at 24 different health insurers covering 125 million employer-sponsored members and 12 million Affordable Care Act members to forecast healthcare inflation. In addition to the predicted 8.5% jump in costs for the group market, the consultancy projected a 7.5% increase for the individual market.”
  • The Wall Street Journal reports
    • “The drugmakers Bristol-Myers Squibb and Pfizer plan to sell the widely used blood thinner Eliquis directly to patients at a discounted cash price—a move that follows the Trump administration’s pressure on the industry to cut drug prices.
    • “The companies, which have a joint venture that markets Eliquis, said the new service will allow uninsured or underinsured patients to buy the pill at more than 40% off the current list price starting Sept. 8. The service will provide direct shipping of the drug to patients in the U.S.
    • “The BMS-Pfizer Alliance is committed to increasing patient access and affordability, which is why we are launching this direct-to-patient offering for Eliquis,” said Bristol-Myers Chief Executive Christopher Boerner.” * * *
    • “Eliquis has a list price of $606 for a 30-day supply but will now offer a discounted cash price of $346 a month.”
  • BioPharma Dive notes,
    • “Abbott lowered its sales forecast for the year, citing a drop in diagnostic testing. CEO Robert Ford told investors on Thursday that the company is seeing a drop-off in COVID-19 testing sales, challenges in China’s core laboratory market and a reduction in U.S. foreign aid funding for HIV testing, with a combined impact of more than $1 billion. 
    • “The company reduced its 2025 organic sales growth forecast to a range of 6% to 7%, from the previous forecast of 7.5% to 8.5% shared in the first quarter.
    • “Even with those billion dollars, we’re still forecasting high single-digit growth and absorbing the impact of tariffs,” Ford said.” 
  • Beckers Hospital Review calls attention to “10 healthcare billing fraud cases that Becker’s has reported on since June 30.”
  • The Institute for Clinical and Economic Review posted today
    • “a revised Evidence Report assessing the comparative clinical effectiveness of nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA). ICER is also assessing the comparative clinical effectiveness and value of apitegromab (Scholar Rock Holdings) for SMA.”
    • “SMA, in its most common forms, has been a devastating degenerative neurologic disease of infants and children,” said ICER’s Chief Medical Officer, David Rind, MD. “Disease modifying therapies and newborn screening have dramatically altered the course of disease and represent one of the great medical success stories in the past decade. However, we still have important uncertainties about how best to utilize these therapies to provide maximal benefits to those affected.” * * *
    • “ICER evaluated the cost-effectiveness of apitegromab only because it will most likely be used as an add-on therapy to nusinersen or risdiplam. Apitegromab has not yet been approved by the FDA for SMA, and the manufacturers have not yet announced a US price for the therapy if approved. 
    • “ICER has calculated a health benefit price benchmark (HBPB) to be between $4,600 and $30,200 per year.” * * *
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on August 1, 2025. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

Thursday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, SCOTUS, SDOH, U.S. Healthcare–

From Washington, DC,

  • On July 2, 2025, the U.S. Office of Personnel Management’s Inspector General issued a Flash Report titled “OPM’s Postal Service Health Benefits Program: Critical Resource Issues,” which Govexec discusses here. The FEHBlog believes and has repeatedly stated that the eligibility program for FEHB and PSHB could be vastly improved if OPM used the widely adopted HIPAA 820 Electronic Enrollment Roster Transaction. The HIPAA 820 transaction would allow carriers to promptly and systematically identify situations where no, or an incorrect, premium payments.
  • The American Hospital Association News reports,
    • Senior leaders from the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, along with White House representatives, visited pharmaceutical company Phlow Corp.’s new production system that manufactures key starting materials, active pharmaceutical ingredients and finished dose forms for 15 medicines used in the U.S. health system. Phlow laboratories and manufacturing facilities are located in the Mid-Atlantic, keeping the complete manufacturing cycle contained in one region. HHS-ASPR and Phlow have collaborated since May 2020 to bring pharmaceutical supply chains into the U.S. and reduce dependency on foreign countries. China and India, for example, account for more than 70% of APIs and KSMs imported to the United States. 
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today unveiled its groundbreaking Functional Repair of Neocortical Tissue (FRONT) program, a transformative initiative to restore brain function and position the U.S. as the global leader in brain repair technology. The FRONT program aligns directly with the priorities set by President Trump and Secretary Robert F. Kennedy, Jr., demonstrating a strong commitment to innovation, public health, and the economic well-being of the American people.
    • “Millions of Americans are living with the damage caused by strokes and traumatic brain injuries. Current treatments are not enough. ARPA-H hopes to deploy regenerative medicine to transform the treatment of neurological diseases and relieve the suffering,” said HHS Deputy Secretary Jim O’Neill.
    • ‘The neocortex, the largest part of the brain, is critical for sensory perception, motor control, and decision-making. Damage to this area—due to conditions like stroke, traumatic injury, or neurodegeneration, such as Alzheimer’s disease—has long led to irreversible damage, leaving individuals dependent on costly therapies or caregivers. The FRONT program aims to change that, using cutting-edge neurodevelopmental principles and stem cell technology to regenerate brain tissue and restore lost functions.”
  • The Brown & Brown actuarial consulting firm helpfully summarizes here the employee benefit provisions of the One Big Beautiful Act.
  • CMS announced resources and flexibilities to address the public health emergency in the State of Texas.

From the judicial front,

  • Govexec reports,
    • “The federal judge who temporarily blocked the Trump administration from implementing mass layoffs before the Supreme Court intervened has suggested she still plans to litigate the legality of individual agency workforce reduction plans. 
    • “The high court this week struck down the injunction that impacted most major agencies, allowing the administration to move forward with widespread RIFs. New layoff notices have not gone out since that decision on Tuesday, but they are expected imminently at several agencies. The court made clear, however, that its ruling applied only to the overall finding of President Trump’s capacity to order staffing cuts and not to the legality of individual agency RIF plans. 
    • “The content of those individual plans “thus remains squarely at issue in this case,” California-based U.S. District Judge Susan Illston, whose original decision led to the RIF pause, said in a new order Wednesday evening.” * * *
    • “Attorneys for the Trump administration previously noted it had 40 RIF actions underway at 17 agencies that were paused by Illston’s injunction. The federal employee unions, local governments and non-profit organizations that originally brought the lawsuit issued an “urgent request” following the Supreme Court decision asking the administration to submit those plans to the court for a decision on their legality. Illston ordered the administration to reply to that request by Monday and suggested she agreed the plans should be submitted for examination. 
    • “The administration previously argued it could not release them because they were predecisional and subject to executive privilege, but the judge on Wednesday suggested that final decisions on the RIFs must have been made if her injunction had paused them from taking effect. She added the court was “not inclined” to allow for significant redactions.” 
    • Here is a Dropbox link to the Court’s order.
  • The New York Times adds,
    • “A federal judge on Thursday blocked the Trump administration from enforcing a contentious executive order ending birthright citizenship after certifying a lawsuit as a class action, effectively the only way he could impose such a far-reaching limit after a Supreme Court ruling last month.
    • “Ruling from the bench, Judge Joseph N. Laplante of the U.S. District Court for the District of New Hampshire said his decision applied nationwide to babies who would have been subject to the executive order, which included the children of undocumented parents and those born to academics in the United States on student visas, on or after Feb. 20.
    • “The Trump administration has fought to challenge the longstanding law, laid out in the Constitution, that people born in the United States are automatically citizens, regardless of their parents’ immigration status. Judge Laplante’s order reignites a legal standoff that has been underway since the beginning of President Trump’s second term.
    • “The judge, an appointee of President George W. Bush, issued a written order formalizing the ruling on Thursday morning. He also paused his order for seven days, allowing time for an appeal.”

From the Food and Drug Administration front

  • BioPharma Dive lets us know,
    • The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased risk for COVID disease.
    • The shot was previously available for these individuals under emergency use authorization. The company said it expects to have an updated version of its shot available in time for the 2025-2026 respiratory disease season.
    • In May, Health and Human Services Secretary Robert F. Kennedy Jr. announced that COVID vaccines would no longer be recommended for healthy children and pregnant people. The Centers for Disease Control and Prevention currently recommends shared clinical decision-making for healthy children.

From the public health and medical research front,

  • The American Journal of Managed Care tells us,
    • “Ovarian cancer mortality rates have declined, but disparities exist across age, race, and geographic regions, with older women and non-Hispanic White women having the highest rates.
    • “Despite treatment advances, late-stage diagnosis remains a barrier due to the lack of routine screening, resulting in low survival rates for advanced-stage ovarian cancer.
    • “Geographic disparities show the Northeast with the highest mortality rates, while both metropolitan and non-metropolitan areas experienced declines, with metropolitan areas showing a steeper decline.
    • “The study’s limitations include the absence of individual-level data on lifestyle factors, tumor histology, and treatment protocols, hindering causal conclusions.”
  • Radiology Business points out,
    • “Shared decision-making visits significantly boost patients’ adherence to low-dose CT lung cancer screening, according to new research published Wednesday. 
    • “Numerous studies have explored poor uptake of LDCT, with rates as low as 18% among eligible individuals.
    • “Researchers with the American College of Radiology’s Neiman Policy Institute recently explored whether “shared decision-making” visits—required by Medicare as part of CT referrals—can boost screening adherence. They found a clear correlation, with imaging rates nearly 27% higher than those who did not meet with their primary care provider to discuss their risks and benefits of lung cancer screening, according to the study results, published in Chest. 
    • “Shared decision-making is more than just a billing requirement—it’s a valuable opportunity to engage patients in informed, personalized discussions about screening,” study author Farouk Dako, MD, MPH, associate professor of radiology, with the Perelman School of Medicine in Philadelphia, said in a July 9 announcement from the Policy Institute. “There is an opportunity to leverage this new evidence in national campaigns to raise awareness of lung screening and the importance of prioritizing SDM in routine clinical care to improve early detection and outcomes for one of the deadliest forms of cancer.” 
  • Gen Edge relates,
    • Scientists have produced the first detailed characterization of the changes that weight loss (WL) causes in human adipose tissue (AT) by analyzing hundreds of thousands of cells from morbidly obese individuals undergoing weight loss surgery. They found a range of positive effects, including clearing out damaged, aging cells and increased metabolism of harmful fats.
    • The team, headed by William R Scott, PhD, at the MRC Laboratory of Medical Sciences and at Imperial College London, analyzed gene expression in more than 170,000 cells that made up the fat tissue samples from 70 people. They generated a high-resolution single-nucleus and spatial atlas of human AT in people with extreme obesity undergoing therapeutic weight loss and in healthy lean counterparts. The investigators suggest that their findings could help scientists better understand how weight loss leads to health improvements at a molecular level, which in the future could help to inform the development of therapies for diseases such as type 2 diabetes.
    • “We’ve known for a long time that weight loss is one of the best ways to treat the complications of obesity, such as diabetes, but we haven’t fully understood why,” Scott said. “This study provides a detailed map of what may actually be driving some of these health benefits at a tissue and cellular level.”
    • “Scott and colleagues reported on the study in Nature, in a paper titled “Selective remodeling of the adipose niche in obesity and weight loss,” in which they stated, “This rich representation of human AT biology and pathophysiology offers a valuable resource for mechanistic and therapeutic exploration.”
  • The New York Times considers “Just How Harmful Is Vaping? More Evidence Is Emerging. A new study that found high levels of heavy metals in popular nicotine vapes adds to concerns about the products.”
  • Per Fierce Pharma,
    • “Pfizer and Astellas are underlining the benefits of Xtandi as part of a combination therapy for certain patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with an overall survival win.
    • “The new data come from the companies’ phase 3 Embark study, which in 2023 led to the FDA approval of Xtandi in patients with nmHSPC with biochemical recurrence (BCR) at high risk of metastasis.
    • “In the trial, Xtandi was studied as a single agent and in combination with leuprolide against placebo and leuprolide. For the trial’s primary endpoint, the Xtandi combo delivered a statistically significant improvement in metastasis-free survival compared with placebo and leuprolide.
    • “At the time, the trial’s overall survival data were mature.
    • “Now, Xtandi plus leuprolide has proved it can, in fact, extend the lives of these patients, demonstrating a “statistically significant and clinically meaningful improvement” in overall survival, Pfizer announced in a July 10 press release.”

From the U.S. healthcare business front,

  • The WTW consulting firm discusses how to strategically manage health and wellness costs in 2025.
  • Healthcare Dive reports,
    • “UnitedHealth has tapped longtime insurance executive Mike Cotton to lead its Medicaid business, filling a role that has stood empty since the company reshuffled its executive team earlier this year, the company confirmed to Healthcare Dive.
    • “Meanwhile, Bobby Hunter, who leads the healthcare juggernaut’s Medicare division, is stepping up as CEO of government programs, with oversight of both Medicare and Medicaid.”
  • Fierce Healthcare notes,
    • “Health Care Service Corporation is launching the HealthSpring brand for its Medicare products after closing the deal to acquire Cigna’s Medicare plans.
    • “Plans under the HealthSpring label were included in the deal, and HCSC said in an announcement that it refreshed the brand identity for a national rollout. The insurer will offer its first plans under the HealthSpring umbrella later this year, pending needed regulatory approvals.”
  • Fierce Biotech informs us,
    • “AbbVie is paying Ichnos Glenmark Innovation (IGI) $700 million upfront for a next-generation rival to Johnson & Johnson’s Tecvayli, positioning the Big Pharma to advance a new option for multiple myeloma patients.
    • “The deal gives AbbVie rights to ISB 2001, a trispecific antibody that targets CD38, BCMA and CD3. J&J’s Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic hit BCMA and CD3. Adding CD38 to the mix could boost binding to tumor cells with low expression of BCMA and stop cancers from becoming resistant by downregulating the antigens.
    • “AbbVie has placed a high price on that potential, coughing up $700 million for a phase 1 candidate and offering up to $1.225 billion in development regulatory, and commercial milestones. In return, IGI has granted AbbVie rights to the trispecific across North America, Europe, Japan and Greater China.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Medical / Rx research, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump stuck to his July 4 deadline for Republicans’ tax-and-spending megabill while signaling there might be some wiggle room as GOP senators struggled to resolve disagreements over Medicaid cuts and other provisions.
    • “Senators said they were aiming for an initial procedural vote as early as noon Saturday, which would let them pass the bill sometime Sunday. Before that, they are aiming to release the final text of the bill and ensure that it can work procedurally in the fast-track process they are using for the party-line legislation.
    • “As of Friday afternoon, Senate Republicans were still negotiating details over the state and local tax deduction, considering a new proposal to set the cap at the House-preferred level of $40,000 for five years before it shrinks. They are also debating changes to Medicaid, including limits on state-financing mechanisms that could squeeze rural hospitals—and a rural-hospital fund to mitigate the effects of their plans. 
    • “Asked at a press conference if he was sticking with his Independence Day target, Trump said: “It’s not the end-all. It could go longer, but we’d like to get it done.”
  • Federal News Network tells us,
    • “A bipartisan bill to revise the rules for federal workers’ compensation cases unanimously advanced out of a House committee this week. The legislation would revise the Federal Employees’ Compensation Act to allow physician assistants and nurse practitioners to treat feds in workers’ compensation cases. A previous version of the bill passed the House in 2022, but did not clear the Senate. Cosponsors of the bill say they’re hopeful it will pass both chambers this Congress.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is announcing a new Innovation Center model aimed at helping ensure people with Original Medicare receive safe, effective, and necessary care. Through the Wasteful and Inappropriate Service Reduction (WISeR) Model, CMS will partner with companies specializing in enhanced technologies to test ways to provide an improved and expedited prior authorization process relative to Original Medicare’s existing processes, helping patients and providers avoid unnecessary or inappropriate care and safeguarding federal taxpayer dollars. This model builds on other changes being made to prior authorization as announced by the U.S. Department of Health and Human Services and CMS on Monday.” * * *
    • “To view the Model Overview fact sheet, visit: https://www.cms.gov/files/document/wiser- fact-sheet.pdf.
    • “For more information on the WISeR Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/wiser.
    • “The WISeR Model can be seen on the Federal Register at: https://www.federalregister.gov/d/2025-12195.
  • Fierce Pharma informs us,
    • “Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now.
    • “The FDA has removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for currently approved BCMA- and CD19-directed CAR-T therapies, the agency said Thursday.
    • “Existing commercial CAR-T products, including Bristol Myers Squibb’s Abecma and Breyanzi, Gilead Sciences’ Yescarta and Tecartus, Johnson & Johnson and Legend Biotech’s Carvykti, and Novartis’ Kymriah, stand to benefit from the update. Autolus’ CD19 CAR-T Aucatzyl was approved in November for B-cell precursor acute lymphoblastic leukemia without a REMS requirement. The FDA’s website only has updated prescribing information for Carvykti as of publication time, but the agency’s announcement said the REMS requirements have been removed for all these drugs.” * * *
    • “These changes should facilitate patient access, particularly for those who do not live near centers of excellence where CAR-Ts are commonly administered,” Citi analysts wrote in a Friday note.”
  • Federal News Network notes,
    • “June 28th is National Insurance Awareness Day, offering a timely reminder for federal employees to reassess their current healthcare needs and determine whether their FEHB plan remains the best fit.
    • “It’s important to review your coverage outside of Open Season, know what to expect for 2026, and be aware of trusted resources that can help guide your decisions.”
    • The article shares information on these points.

From the judicial front,

  • The Supreme Court completed its October 2024 term today.
  • Roll Call reports,
    • The Supreme Court curtailed the power of district courts to issue “universal injunctions” in a decision Friday in the legal clash over the Trump administration’s push end birthright citizenship.
    • The 6-3 decision [liberals dissenting] found that most of those broad orders that stop government actions — and there have been dozens issued against the Trump administration this year — exceed the power Congress gave to federal district courts.
    • The decision sends litigation over the legality of President Donald Trump’s birthright citizenship effort back to the lower court and is likely to set off an avalanche of litigation in more than 100 lawsuits against Trump’s administrative actions.
  • The FEHBlog expects that plaintiffs will be converting their lawsuits to class actions.
  • Govexec adds,
    • “The Supreme Court on Friday limited individual judges’ capacity to strike down government policy on a nationwide basis, a decision with potentially far-reaching impacts on how federal agencies carry out their work. 
    • “The high court left in place some carve outs, however, including one that could—at least temporarily—protect a judge’s ruling that is currently blocking the Trump administration from carrying out widespread layoffs. While the Trump administration applauded the Supreme Court’s decision and lamented the influence that lower-level judges have exerted over the president’s control of the federal workforce, attorneys who helped bring the lawsuit forward suggested it did not apply to the order preventing large-scale reductions in force.” * * *
    • “The victory for federal employees, to the extent they can claim one after the Supreme Court’s decision, may be short lived. The administration has already appealed both RIF cases to the [Supreme Court], where it is now awaiting resolution. It has done so seeking emergency relief and a decision is expected any day.” 
       
  • The Wall Street Journal sums it up as follows:
    • The Supreme Court ruled against nationwide injunctions, limiting the scope of lower-court rulings against presidential policies.
    • The high court ruling might lead to more lawsuits against the administration, as individuals and groups must bring their own cases.
    • Lawyers are exploring class-action suits, and state attorneys general might gain influence challenging White House policies.
  • The American Hospital Association News relates,
    • “The Supreme Court today voted 6-3 [conservatives dissenting] to uphold an Affordable Care Act provision creating an independent task force charged with making recommendations of preventive services that insurers must cover at no cost. The ruling reverses a June 2024 decision by the U.S. Court of Appeals for the 5th Circuit, which partially affirmed a district court judgment that the U.S. Preventive Services Task Force, the group charged with determining coverage of certain preventative services, was unconstitutional.” 
    • The Court held that the USPSTF members, who are volunteers, are inferior officers of the United States, who can be appointed by someone other than the President, in this case, the HHS Secretary, without Senate confirmation.
    • The opinion helpfully preserves the ACA preventive care status quo.
  • KFF calls attention to legal issues that the Court’s opinion may not have resolved.
  • SCOTUSblog covers the other Supreme Court decisions issued today.
  • The AHA News also tells us,
    • “A U.S. District Court for the District of Columbia judge today ruled against Johnson and Johnson and sided with the Department of Health and Human Services and hospitals in a lawsuit brought by J&J challenging the government’s authority to reject J&J’s proposed 340B rebate model.  
    • “In sum, based on the plain and unambiguous language of the 340B statute, and supported by its purpose and history, HRSA has the authority to ‘provide’ for discounts, rebates, or both,” Judge Rudolph Contreras wrote. “This conclusion defeats J&J’s claim that HRSA lacked the authority to require prior approval of J&J’s rebate model.” 
    • “The AHA in a friend-of-the-court brief urged the court to uphold the government’s decision to reject J&J’s proposed 340B rebate model. Others joining the AHA in the filing were the Children’s Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals. 
    • “Earlier this year, a second district judge reached the same conclusion in cases brought by five other drug companies.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity is low. COVID-19 and RSV activity is very low.
    • “COVID-19
      • “COVID-19 wastewater activity, emergency department visits and laboratory percent positivity are at very low levels.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • Per Health Day,
    • “Updated COVID-19 vaccines are keeping up with new coronavirus strains and remain effective for keeping people out of the hospital, a new study says.
    • “The study, which examined the effectiveness of the 2023-2024 COVID vaccines against the XBB and JN.1 Omicron variant waves, found that the updated shots caused:
      • “A 24% lower risk of ER and urgent care visits related to COVID.
      • “A 29% lower risk of hospitalization.
      • “A 48% lower risk of ICU admission or death in hospital.
    • “This protection stretched from a week after vaccination out to 299 days afterward, researchers reported June 25 in JAMA Network Open.
    • “Maximum protection came during the first two months after vaccination, reducing severe cases of COVID by up to 68%, results show.
    • “However, vaccine effectiveness waned over time, particularly beyond the six-month mark.”
  • The University of Minnesota’s CIDRAP reports,
    • “The US Centers for Disease Control and Prevention (CDC) is now updating its measles totals on Wednesdays, and on June 25 it reported 13 more cases, putting the national total at 1,227 in 37 states. The nation’s cases are just 48 cases shy of passing the record number of cases reported in the 2019 surge, which was the most since measles was eliminated in the United States in 2000.
    • “The number of outbreaks remained at 23, and 89% of the confirmed cases are linked to outbreaks. Of the confirmed case-patients this year, 95% were unvaccinated or have an unknown vaccination status. So far, 148 people have been hospitalized, and the number of deaths remains at 3.”
  • and
    • “The percentage of US adults reporting high confidence in the Centers for Disease Control and Prevention (CDC) fell from 82% in February 2020 to 56% in June 2022, along with decreasing trust in other US health institutions, according to a study yesterday in PLOS Global Public Health.
    • “For the study, researchers from the University of Texas Southwestern Medical Center in Dallas conducted four surveys from February 2020 to October 2024 that assessed Americans’ confidence in US health institutions including the CDC, National Institutes of Health (NIH), Department of Health and Human Services (HHS), state and local health departments, professional medical organizations, the White House, and their own doctor. Sample sizes were 718, 672, 856, and 828, respectively.
    • “All four surveys asked participants their perceptions of public health organizations and who they thought should lead the US response to infectious disease outbreaks. Surveys 1 and 2 also asked questions on the COVID-19 pandemic, while surveys 3 and 4 asked questions around the 2022 and 2024 mpox outbreaks.” * * *
    • “The rate of those expressing high confidence then rebounded only slightly, to 60%, in October 2024.” * * *
    • “In a press release from PLOS, which published the journal, first author Hannah Melchinger says, “We need to take this decline seriously if we want to preserve the credibility of these entities and their public health recommendations.”
  • Per MedPage Today,
    • “Maternal flu vaccination was associated with a reduced risk of influenza infection during infants’ first 6 months of life, an age when they are too young to be vaccinated, a cohort study of nearly a quarter-million women and their babies found.
    • “Flu vaccination during pregnancy was associated with an adjusted 44.4% (95% CI 31.4-54.9) reduction in the risk of infant influenza infection, with protection strongest during the infants’ first few months of life, reported researchers led by Ousseny Zerbo, PhD, of Kaiser Permanente Northern California (KPNC) in Oakland, in Obstetrics & Gynecology.”
  • Health Day notes,
    • “People living with an autoimmune disease are nearly twice as likely to suffer from mood problems like depression, anxiety or bipolar disorder, a new large-scale study says.
    • “The risk of mood disorders is 87% to 97% higher in people suffering from rheumatoid arthritis, inflammatory bowel disease, lupus, multiple sclerosis, psoriasis and Graves’ syndrome, researchers reported June 24 in the BMJ Mental Health.
    • “This risk remains higher even after accounting for other factors like age, income and family history of psychiatric disorders, researchers found.
    • “Together, these results support the hypothesis that exposure to chronic inflammation may be associated with a greater risk for affective disorders,” concluded the research team led by Arish Mudra Rakshasa-Loots with the University of Edinburgh Center for Clinical Brain Sciences in the U.K.”
  • UConn which the FEHBlog’s alma mater writes in Linked In,
    • “Millions of Americans suffer from osteoarthritis, a painful joint disease that wears down cartilage and can severely impact mobility. Pain medications only mask symptoms, and surgical option carry risks of infection and immune rejection.
    • “At the University of Connecticut, a research team led by Thanh Nguyen, associate professor of mechanical engineering and biomedical engineering, believes the future of joint repair might lie in a tiny electrical spark—and a simple injection.
    • “Backed by a $2.3M grant from the National Institutes of Health (NIH) and National Institute of Biomedical Imaging and Bioengineering (NIBIB), Nguyen and his team are developing an injectable hydrogel designed to stimulate cartilage regeneration in large animal models.
    • “With current treatments, we’re managing the pain, not healing the tissue,” says Nguyen. “We’re hoping that the body’s own mechanical movements—like walking—can generate tiny electrical signals that encourage cartilage to grow back.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lets us know about nine major hospital construction projects unveiled or advanced this year and notes that “Eliminating a $45 out-of-pocket fee for 3D mammography, also called digital breast tomosynthesis, increased utilization of the procedure by 7.8%, according to a study published June 19 in the Journal of the American College of Radiology.” 
  • Per HealthLeaders,
    • “Hospital at Home, which aims to treat selected patients at home with a combination of virtual care, remote patient monitoring and daily in-person visits instead of keeping them in the hospital, took off during the pandemic, with support from a waiver that enabled health systems and hospitals following the CMS model to receive Medicare reimbursement. That waiver is due to expire in September, and while there’s a strong lobbying effort to make it permanent, many hospital executives have said the program has proven its value and will go on regardless.”
  • Fierce Pharma discusses expert views on the status of the compounding industry now that the shortage of Novo and Lilly GLP-1 drugs is over.
  • Healthcare Dive reports,
    • “Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the pharmaceutical supply chain are likely to run up against a fundamental issue: the three major pharmacy benefit managers’ chokehold on the U.S. drug market, experts said during a drug pricing transparency forum in Washington, D.C. this week.”
    • The FEHBlog thinks that this is Pharma distraction.

Thursday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Several of Republicans’ largest proposed spending reductions can’t be done as written in the fast-track budget process they are using to advance their megabill, the Senate parliamentarian determined, dealing a setback to the GOP’s hopes of passing their plans quickly. 
    • “The ruling affects several of the largest and most controversial reductions in President Trump’s “one, big, beautiful bill,” and Republicans will likely be forced to drop or rewrite them. The changes could amount to hundreds of billions of dollars, making it harder for Republicans to hit their budget targets.
    • “But the ruling wasn’t the final word, and Senate Republicans said by Thursday afternoon that they thought some slight tweaks to the wording of some proposed Medicaid cuts would be enough to break the logjam.
    • “There are things that we can do, there are other ways of getting to that same outcome,” said Senate Majority Leader John Thune (R., S.D.). Sen. John Hoeven (R., N.D.) said that such a plan was already under way, and that Republicans expected to hear back soon from the parliamentarian. 
    • “We’ve proposed some things to the parliamentarian that we think can work,” Hoeven said.’
  • Fierce Pharma tells us,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) has blessed Merck’s new respiratory syncytial virus (RSV) shot Enflonsia, but the decision was hardly resounding from Robert F. Kennedy Jr.’s newly formed panel of advisors.
    • “The ACIP signed off on recommending Merck’s newly approved monoclonal antibody by a vote of 5 to 2. The committee endorses one dose of Enflonsia to be given to infants younger than 8 months of age who are born during or entering their first RSV season and who are not already protected by a maternal vaccine.” * * *
    • “The new recommendation for Enflonsia, which was approved by the FDA just two weeks ago, matches that of Sanofi and AstraZeneca’s Beyfortus, which has been on the market for the last two years and generated sales of $1.8 billion in 2024.”
  • BioPharma Dive adds,
    • “Advisers to the Centers for Disease Control and Prevention recommended Thursday that influenza vaccines used in the coming flu season be free of the preservative thimerosal, addressing unproven fears the mercury-containing substance can lead to developmental disabilities.
    • “If confirmed by the CDC, the recommendation from the Advisory Committee on Immunizaiton Practices, or ACIP, would affect about 5% of flu shots administered in the U.S., distributed in multidose vials that necessitate the use of a preservative to prevent bacterial or fungal contamination. Only three such vaccines are approved for U.S. use, two from CSL and one from Sanofi.
    • “Meeting for the first time with members appointed by Health and Human Services Secretary Robert F. Kennedy Jr., ACIP also reviewed a change in its recommendations for measles vaccines, although it won’t vote on that proposal until a meeting later this year.”
  • The Wall Street Journal sums it up as follows:
    • “The Advisory Committee on Immunization Practices, or ACIP, was established in 1964 to offer the federal government advice on which vaccines Americans should get and when. After Kennedy dismissed its 17 members and picked new ones, the committee spent two days examining science’s weapons to combat flu, measles and other diseases—with a new emphasis on the risks of the weapons themselves.
    • “Vaccines are not all good or bad,” said the committee’s new chair, Martin Kulldorff, a former Harvard professor. “No questions should be off-limits.” * * *
    • “In a joint statement after the two-day session concluded Thursday, the committee said it had “no predetermined ideas and will make judgments as if we are treating our own families,” adding that “unbiased scientific thinking is fundamental to the committee’s charge.”
  • The Census Bureau informs us,
    • “The U.S. population age 65 and older rose by 3.1% (to 61.2 million) while the population under age 18 decreased by 0.2% (to 73.1 million) from 2023 to 2024, according to the Vintage 2024 Population Estimates released today by the U.S. Census Bureau.
    • “The data show the population continued to age, with the share of the population age 65 and older steadily increasing from 12.4% in 2004 to 18.0% in 2024, and the share of children declining from 25.0% to 21.5%.
    • “Ongoing growth among the older population, coupled with persistent annual declines in the population under age 18 has reduced the size difference between these two age groups from just over 20 million in 2020 to just below 12 million in 2024. From 2020 to 2024, the older population grew by 13.0%, significantly outpacing the 1.4% growth of working-age adults (ages 18 to 64), while the number of children declined by 1.7%.
    • “Children still outnumber older adults in the United States, despite a decline in births this decade,” said Lauren Bowers, chief of the Census Bureau’s Population Estimates Branch. “However, the gap is narrowing as baby boomers continue to age into their retirement years. In fact, the number of states and counties where older adults outnumber children is on the rise, especially in sparsely populated areas.”
  • Tammy Flanagan, writing in Govexec, offer guidance to those who are “Retired and confused about Medicare Part B. You’re not alone. From late penalties to premium reimbursements, here’s what every retired fed should understand about enrolling in Medicare Part B—and how it works with your FEHB plan.

From the judicial front,

  • The Supreme Court will complete issuing opinions from its October 2024 term tomorrow morning at 10 am.
  • Beckers Hospital Review relates,
    • “Several Iowa businesses and health plans are suing to block a new state law regulating pharmacy benefit managers, arguing it violates federal law and the Constitution, Iowa Capital Dispatch reported June 23. 
    • “The lawsuit, filed June 23 in the U.S. District Court for the Southern District of Iowa, challenges Senate File 383, a measure signed in early June by Gov. Kim Reynolds. The plaintiffs include the Iowa Association of Business and Industry, Des Moines Orthopaedic Surgeons PC, Iowa Springs Manufacturing & Sales Co., and health plans like the Iowa Bankers Benefit Plan and Iowa Laborers District Council Health and Welfare Fund. 
    • “While supporters said the provisions will help struggling pharmacies in many Iowa communities, the lawsuit argued the new law will “raise healthcare costs for businesses across the state — large and small — by tens of millions of dollars.” 
  • Bloomberg Law adds,
    • “Four lawsuits seeking to invalidate a first-of-its kind Arkansas law prohibiting companies that manage prescription drug benefits from acquiring pharmacies will be heard together in federal court, a judge ruled Tuesday.
    • “The order from Judge Brian S. Miller for the US District Court for the Eastern District of Arkansas grants an unopposed motion filed by the Arkansas attorney general’s office to consolidate the cases. The challenges were brought by pharmacy benefit managers Express Scripts, CVS Health Corp., and OptumRx, as well as the industry group Pharmaceutical Care Management Association.” * * *
    • “Miller ordered Tuesday that all future filings in the four cases be filed in the docket for Express Scripts’ lawsuit. The members of the Arkansas pharmacy board, who are represented by the state attorney general’s office, must file by July 11 a consolidated response to PBMs’ motion for a preliminary injunction on the law, according to the order. 
    • “The case is Express Scripts v. Richmond , E.D. Ark., No. 4:25-cv-00520, motions to consolidate granted 6/24/25.” 
  • Beckers Hospital Review lets us know about ten recent healthcare billing fraud cases.

From the public health and medical research front,

  • Fox Business reports,
    • Trader Joe’s said Friday [June 20] that a “single lot code” of the cheese curds have been recalled in response to the potential risk of Listeria monocytogenes contamination.
    • The recalled product was offered at some Trader Joe’s locations in Northern California as well as stores in the Nevada cities of Carson City, Reno and Sparks, according to a notice posted on the popular grocery store chain’s website. 
    • The stores in Northern California included those in Monterey, Fresno and “all locations North,” Trader Joe’s said. 
    • “The recalled cheese curds have a use-by date of “082925” on their container.” 
  • Beckers Hospital Review ranks states by opioid overdose deaths.
    • “West Virginia had the highest rate of fatal opioid overdoses of any state in 2023, according to a new analysis from KFF. 
    • “The analysis is based on finalized 2023 opioid overdose death totals from the CDC’s WONDER database, which uses ICD-10 codes to identify deaths where synthetic and prescription opioids are listed as a contributing cause.
    • “Becker’s calculated each state’s death rate per 100,000 residents using 2023 U.S. Census population estimates to enable fair comparisons across states.
    • “The national opioid overdose death rate was 23.69 per 100,000 residents in 2023.”
  • News Medical points out,
    • “Weight loss surgery has long been an effective treatment for the more than 40 percent of American adults struggling with obesity. Previous studies have shown that Black patients lose less weight overall following bariatric surgery compared to other racial groups, but less attention has been paid to the relationships between economic and social factors that may help explain differences in weight loss.
    • “New research led by NYU Langone Grossman School of Medicine found that Black patients who had a sleeve gastrectomy, the most common weight loss surgery, between 2017 and 2020 lost 6.2 percent less weight than their White counterparts, and 4.9 percent less than Hispanic patients, after one year. However, further analyses found that a lot more complexity and interplay between non-biological factors than previously known appear to impact weight loss surgery incomes.
    • “Published online in the journal Obesity, this is the first study to investigate the relationship between a variety of economic and social factors that include income, sleep disturbances and stress, and weight loss differences among racial groups, the study authors said.”
  • Per Health Day,
    • “Fitness trackers aren’t accurately assessing the physical activity of people with obesity, a new study argues.
    • “Differences in walking gait, speed, energy burn and other factors mean that folks with excess weight aren’t getting an accurate read from their devices, researchers wrote in the journal Scientific Reports.
    • “People with obesity could gain major health insights from activity trackers, but most current devices miss the mark,” senior researcher Nabil Alshurafa, an associate professor of behavioral medicine at Northwestern University Feinberg School of Medicine in Chicago, said in a news release.
    • “Alshurafa’s team has developed a new algorithm that enables smartwatches to more accurately monitor the calories burned by people with obesity, researchers said.
    • “Lab tests show that the new algorithm achieves over 95% accuracy in real-world situations, the study says.
    • “Without a validated algorithm for wrist devices, we’re still in the dark about exactly how much activity and energy people with obesity really get each day — slowing our ability to tailor interventions and improve health outcomes,” Alshurafa said.”
  • Per MedPage Today,
    • “AS01-adjuvanted RSV and shingles vaccines were tied to a lower dementia risk in older adults.
    • “Compared with flu vaccine recipients, those who had the AS01 RSV shot had 29% more dementia-free time over 18 months.
    • “No differences emerged between the two AS01 vaccines, implying the adjuvant may play a role.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The leader of UnitedHealth Group Inc.’s Optum Health care delivery unit has left the role, an early indication of management changes under Stephen Hemsley, UnitedHealth’s new chief executive officer.
    • “The division will now be led by Patrick Conway, who was recently promoted to CEO of the broader Optum division that includes Optum Health. Conway will add the title of Optum Health CEO, according to a company memo reviewed by Bloomberg News.
    • “Amar Desai had been CEO of Optum Health since 2023. He’ll become president of Optum integrated care and vice-chairman of Optum Health, according to the memo, and will continue to work with Conway and Hemsley.”
  • Healthcare Dive tells us,
    • “Declines in Walgreens’ front-of-store retail sales continued in Q3, falling 5.3% year over year, due largely to store closures and lower same-store sales. The drugstore retailer last year announced it would shutter 1,200 U.S. stores over three years.
    • “Weak sales in grocery and household, health and wellness, and beauty drove store comps down 2.4%. The international and U.S. healthcare segments fared better, helping drive a 7.2% overall Q3 sales increase to $39 billion.
    • “The drugstore retailer swung into the red with a net loss of $175 million, a decrease of $519 million compared to last year’s $344 million in net earnings.”
  • Per MedTech Dive,
    • “Johnson & Johnson has partnered with Nvidia and Amazon Web Services, or AWS, to support the use of artificial intelligence in surgery, the medtech company said Wednesday.
    • “The Polyphonic AI Fund for Surgery builds on J&J’s existing collaboration with Nvidia and creation of a digital platform for in-house and third-party surgical applications.
    • “Through the fund, J&J, Nvidia and AWS will evaluate, and support projects related to AI model development, data engineering and management, and AI governance.”
  • Per Tech Target,
    • The Lown Institute is recognizing 125 hospitals nationwide for their performance on health equity, value and outcomes, honoring these for this corporate social responsibility in healthcare.
    • “These hospitals show that no matter how tough the environment gets, putting patients and communities first is always possible,” Vikas Saini, M.D., president of the Lown Institute, said in a press release. “Those returning to the list prove that equitable, high-value care doesn’t have to be rare; it’s a standard that hospitals can uphold year after year.” * * *
    • “The top 10 acute care hospitals for health equity, value and outcomes include the following:
      • “Duke Regional Hospital (Durham, N.C.).
      • “Fort Loudoun Medical Center (Lenoir City, TN..).
      • “Baylor Scott & White Medical Center – Pflugerville (Pflugerville, TX.).
      • “Denver Health Main Campus (Denver, CO.).
      • ‘Methodist Medical Center (Oak Ridge, TN.).
      • “Prisma Health Baptist Hospital (Columbia, S.C.).
      • “TriStar Horizon Medical Center (Dickson, TN.).
      • “Sharon Hospital (Sharon, CT.).
      • “Inspira Medical Center Vineland (Vineland, N.J.).
      • “Southern California Hospital at Hollywood (Los Angeles, CA.).”
  • MedCity News reports,
    • “Novavax’s alliance with Sanofi came at an opportune time for the beleaguered vaccine developer. Its protein-based Covid-19 vaccine never reached the revenue highs achieved by the messenger RNA vaccines for the novel coronavirus. A corporate restructuring slashed headcount and R&D spending, but Novavax’s financial reports still flagged concerns about the company’s ability to continue.
    • “The Sanofi partnership(Opens in a new window) inked a little more than a year ago infused Novavax with $500 million up front, staving off the immediate financial worries. Starting this year, Sanofi will record sales of the Covid-19 shot vaccine Nuvaxovid, paying Novavax royalties on those sales. The deal is more than a financial lifeline. Beyond sharing in Nuvaxovid’s commercialization, Sanofi can research potential combinations of the Covid-19 shot with its own influenza vaccines. The pharmaceutical giant may also explore using Novavax’s adjuvant in its own vaccines. This agreement is a blueprint for the kinds of alliances Novavax is now pursuing, according to Ruxandra Draghia-Akli, executive vice president, head of research and development.
    • “It’s a multifaceted partnership and we thought that is a model, or maybe components of that model can be developed with other partners,” she said in an interview during the recent BIO International Convention in Boston.”
  • Per Fierce Pharma,
    • “After blueprinting an injectables facility in North Carolina in 2020, it didn’t take long for Eli Lilly to draw up designs for a second in the Tar Heel State.
    • “Following declines in the manufacturing, textiles and tobacco industries that once formed the core trades in the state, North Carolina has increasingly put its chips behind biotechnology. It’s a strategy that has attracted not only Lilly but myriad other pharma majors like Fujifilm Biosciences, Johnson & Johnson and Thermo Fisher Scientific.
    • “For Lilly, building a new parenteral products and devices facility in the city of Concord was a natural evolution following the decision to throw down $470 million on a similar injectables plant at North Carolina’s famed Research Triangle Park back in 2020.” * * *
    • “Together, Lilly’s two North Carolina facilities—which are used in part to make incretin medicines such as Zepbound and Mounjaro—are part of the drugmaker’s ongoing, multibillion-dollar investment in U.S. infrastructure. They also form part of a bulwark against the immense demand for Lilly’s dual GIP/GLP-1 products for diabetes and obesity.”
  • and
    • “Novo Nordisk continues to expand its partnerships with telehealth companies to broaden access to its blockbuster weight loss drug Wegovy.
    • “The pharma giant is now partnering with WeightWatchers to offer consumers access to Wegovy, using CenterWell Pharmacy to fulfill and deliver the medications. CenterWell is owned by Humana.
    • “WeightWatchers aims to provide patients with a more streamlined experience, along with convenient access to FDA-approved medication with the lifestyle support shown to improve outcomes, the company said in a press release.
    • “The partnership will start July 1.”




Monday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Obesity, U.S. Healthcare–
  • Govexec tells us,
    • “Last week, Senate Homeland Security and Governmental Affairs Committee Chairman Rand Paul, R-Ky., unveiled his panel’s portion of congressional Republicans’ budget reconciliation package, which aims to reduce federal spending to partially pay for extended tax cuts for the ultrawealthy and increased immigration enforcement. The measure abandoned a series of House-passed proposals to cut the retirement benefits of currently serving federal workers but would have required future federal hires to pay nearly 15% of their paychecks toward their retirement benefits if they wished to accrue civil service protections.
    • “But Sen. Jeff Merkley, D-Ore., top Democrat on the Senate Budget Committee, announced Sunday that the Senate parliamentarian had ruled that most of the Senate’s proposals governing federal benefits and workforce policies violated the Byrd rule, which aims to limit reconciliation measure—and its simple majority threshold for passage—to topics that are budgetary in nature.” * * *
    • “Provisions that would require a 60-vote majority to advance include the plan to require all new federal employees to pay 9.4% toward the Federal Employees Retirement System and to choose between paying an additional 5 percentage points toward FERS or serving as at-will employees; a requirement that federal employees challenging an adverse action before the Merit Systems Protection Board pay a $350 filing fee, as well as a proposal to charge federal employee unions for use of agency property and official time on a quarterly basis.
    • “The parliamentarian also said that a provision effectively giving the Trump administration “carte blanche” to reorganize federal agencies and lay off thousands of federal workers would similarly run afoul of the Byrd rule. Earlier this month, Senate Majority Leader John Thune told reporters that he would not consider overruling the parliamentarian as part of the bid to send the reconciliation package to President Trump’s desk by July 4.
    • “Still remaining in the package is a provision tasking the Office of Personnel Management with conducting an audit of enrollees in the Federal Employees Health Benefits Program to ensure family members remain eligible as dependents, and a requirement that the government charge a 10% fee on deductions from federal workers paychecks, such as unions dues and charitable contributions as part of the Combined Federal Campaign.”
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services June 23 announced an initiative coordinated with multiple health insurance companies to streamline prior authorization processes for patients covered by Medicare Advantage, Medicaid managed care plans, Health Insurance Marketplace plans and commercial plans. Under the initiative, electronic prior authorization requests would become standardized by 2027. HHS stated that these reforms complement ongoing regulatory efforts by CMS to improve prior authorization, including building upon the Interoperability and Prior Authorization final rule. 
    • “The plan is expected to make the prior authorization process faster, more efficient and more transparent, the agency said. Participating insurers pledged to expand real-time responses by 2027. HHS said that the insurers would also commit to reducing the volume of medical services subject to prior authorization by 2026, including those for common procedures such as colonoscopies and cataract surgeries. 
    • “During a news conference, HHS Secretary Robert F. Kennedy Jr. said unlike previous attempts by insurers, this initiative would succeed because the number of insurers participating represent 257 million Americans. “The other difference is we have standards this time,” he said. “We have … deliverables. We have specificity on those deliverables, we have metrics, and we have deadlines, and we have oversight.” 
    • “Mehmet Oz, M.D., CMS administrator, said that the pledge “is an opportunity for industry to show itself.” Sen. Marshall, R-Kan., said that Congress could pursue codifying at least some portions of the initiative in the future. 
    • “Additionally, participating insurers would honor existing prior authorizations during coverage transitions.” 
  • Here are links to AHIP and BCBSA announcements concerning this prior authorization development.
  • Think Advisor points out,
    • “Most Medicare programs use current premium revenue and government contributions to pay for their operations.
    • “One Medicare program, the Medicare Part A inpatient hospitalization program, is supposed to use the earnings on assets stored in a trust fund to cover some costs.
    • “Assets at the trust fund have fallen below $209 billion — less than the asset total at UnitedHealth or CVS Health.
    • ‘Medicare trustees say they now expect the trust fund to run dry in 2033. That’s down from a depletion year of 2036 included in last year’s report.
    • “But if the Part A trust fund runs dry, and Congress makes no changes, payroll taxes and premium revenue should be high enough to cover about 89% of the promised inpatient hospitalization benefits, according to the trustees.
    • “The trustees’ estimate of the share of promised benefits ongoing revenue can pay is unchanged from last year.”
  • HHS lets us know,
    • “On June 18, 2025, [as the FEHBlog noted at the time] the U.S. District Court for the Northern District of Texas issued an order declaring unlawful and vacating most of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy at 89 Federal Register 32976 (April 26, 2024).
    • “With regard to the modifications to the HIPAA Privacy Rule Notice of Privacy Practices (NPP) requirements at 45 CFR 164.520, the court vacated only the provisions that were deemed unlawful, namely 164.520(b)(1)(ii)(F), (G), and (H).
    • “The remaining modifications to the NPP requirements are undisturbed and remain in effect, see Carmen Purl, et al. v. U.S. Department of Health and Human Services, et al., No. 2:24-cv-00228-Z (N.D. Tex. June 18, 2025).
    • “Compliance with the remaining NPP modifications is required by February 16, 2026. HHS will determine next steps after a thorough review of the court’s decision.”
    • In the FEHBlog’s view, it’s a safe bet that HHS will not appeal this decision.
  • BioPharma Dive notes,
    • “A top Food and Drug Administration official responsible for overseeing drug reviews is reportedly retiring from the agency, adding to an exodus of senior staff who have either left or been forced out by Trump administration leadership.
    • “Jaqueline Corrigan-Curay, who serves as acting head of the FDA’s Center for Drug Evaluation and Research, will depart next month, according to reports from Endpoints News, Stat News and other publications.
    • “Corrigan-Curay became acting CDER director after Patrizia Cavazzoni left the position shortly before the Trump administration took office. A physician and lawyer, Corrigan-Curay joined the FDA in October 2016 and was appointed principal deputy center director at CDER in 2021.”
  • Bloomberg Law reports,
    • “Republican Senator Bill Cassidy is seeking to delay a scheduled meeting of vaccine advisers selected by Health and Human Services Secretary Robert F. Kennedy Jr. out of concern they’re not sufficiently qualified.
    • “Cassidy, who’s from Louisiana and leads the Senate’s health committee, publicly called on the Trump administration to put off the meeting slated for Wednesday via a post on the social platform X on Monday.
    • “Wednesday’s meeting should not proceed with a relatively small panel, and no CDC Director in place to approve the panel’s recommendations,” posted Cassidy.” * * *
    • “Cassidy will run the hearing for President Donald Trump’s CDC director nominee, Susan Monarez, on Wednesday. That’s the same day that the vaccine advisers are expected to begin their meeting. 
    • “Spokespeople for CDC and HHS did not immediately respond to requests for comment.”

From the public health and medical research front,

  • Health Day reports,
    • “Hypertension is the most common chronic condition among adults aged 85 years and older, with prevalence higher among women than men, according to a report published in the June Health E-Stats, a publication of the National Center for Health Statistics.
    • “Yelena Gorina, M.P.H., and Ellen A. Kramarow, Ph.D., from the National Center for Health Statistics in Hyattsville, Maryland, used data from the 2022 and 2023 National Health Interview Survey to present estimates of the percentage of adults aged 85 years and older with 11 selected chronic conditions.
    • “The number of American adults aged 85 years and older was 6.1 million in 2023 and is projected to reach 13.7 million by 2040. The authors note that the most common of the selected chronic conditions reported were hypertension, arthritis, and high cholesterol among civilian noninstitutionalized adults aged 85 years and older (66.9, 55.9, and 46.5 percent, respectively). For both men and women, hypertension was the most common chronic condition reported, with a higher prevalence for women than men (68.9 versus 63.7 percent). The prevalence of arthritis was also higher for women than men (63.2 versus 44.2 percent), but men had a higher prevalence of high cholesterol (50.5 versus 44.0 percent), cancer (39.8 versus 28.6 percent), heart disease (31.5 versus 26.3 percent), and diabetes (19.3 versus 14.5 percent).”
  • The American Medical Association tells us what doctors wish their patients knew about thyroid cancer.
  • Beckers Hospital Review lists by state the 514 U.S. hospitals 514 hospitals with “a catheter associated urinary tract infection rate of zero, as based on the healthcare-associated infections dataset from CMS.”
  • The New York Times reports at length on the impact of the measles outbreak on healthcare providers and public health officials in rural America.
  • Consumer Reports, writing in the Washington Post, discusses “using cannabis for health problems It’s being used for everything from pain to insomnia. When it might help and when it won’t — in any case, don’t vape or smoke it.”
  • FiercePharma relates,
    • “Roche has demonstrated the power of combining two of oncology’s hottest modalities—bispecifics and antibody-drug conjugates (ADCs)—in a Lunsumio-Polivy regimen in large B-cell lymphoma (LBCL).
    • “The combination of the CD20xCD3 bispecific Lunsumio and the CD79b-directed ADC Polivy significantly reduced the risk of progression or death by 59% versus the traditional R-GemOx regimen in patients with previously treated LBCL who are not eligible for stem cell transplant. R-GemOx includes Roche’s own Rituxan and the chemotherapies gemcitabine and oxaliplatin.
    • “Patients in the Lunsumio-Polivy group went a median 11.5 months without disease progression versus 3.8 months for R-GemOx, according to the primary analysis of the phase 3 Sunmo study presented at the International Conference on Malignant Lymphoma.
    • “Roche said it will submit the trial results to global health authorities, including the FDA. While Lunsumio is currently approved as an intravenous infusion to treat follicular lymphoma, the Sunmo trial uses a subcutaneous formulation of the drug. Polivy, meanwhile, received the FDA’s approval as part of a combination for certain previously untreated patients with LBCL in 2023.”
  • The Wall Street Journal reports,
    • “Novo Nordisk’s new weight-loss drug helped patients lose even more weight on average than its current Wegovy blockbuster treatment, an early-stage trial showed, as the drugmaker races to develop the next generation of obesity medicines.
    • “The company’s drug, known as amycretin, helped patients lose over 24% of their weight, which compares with an average of about 17% for its Wegovy treatment.
    • “The drug mimics the same gut hormone as the Wegovy treatment to suppress appetite, delay stomach emptying and control blood sugar, but combines it with amylin, a hormone in the pancreas that also regulates appetite.
    • “The new treatment was administered as a once-weekly shot and a daily pill, with results showing that side effects were mostly in line with other obesity medications. Patients taking the amycretin injection lost an average of 24.3% of their weight when dosing up to a 60-milligram shot over 36 weeks of treatment, while those on the pill lost up to 13.1% over 12 weeks.” * * *
    • “The data was published in the Lancet and presented at the American Diabetes Association conference over the weekend. Novo Nordisk plans a late-stage trial for the new drug early next year.”
  • STAT News also reports from the American Diabetes Association meeting,
    • “An investigational therapy from Eli Lilly helped preserve lean mass and drive greater loss of fat in patients taking the popular obesity treatment Wegovy.
    • “In a Phase 2 trial, patients taking the highest-dose combination of Wegovy and the drug, called bimagrumab, lost 22% of their weight at 72 weeks. Ninety-three percent of that was fat mass, and the rest was lean mass. People taking Wegovy alone lost a smaller 16% of their weight, and 72% of that was fat mass, according to results that will be presented Monday at the American Diabetes Association meeting.”
  • and
    • “Amgen’s monthly obesity candidate led to substantial weight loss but a high rate of side effects and discontinuations in a mid-stage trial, results that support the company’s decision to use a slower dosing schedule to make the drug more tolerable in further testing. 
    • “In the Phase 2 study, patients with obesity taking the injectable drug, called MariTide, lost up to 16.2% of their weight in one year when taking into account all participants regardless of discontinuations. Patients lost up to 19.9% when analyzing only those who stayed on treatment.”
  • and
    • “Obesity drugs were first approved to treat type 2 diabetes, but there’s a growing movement to test them in type 1 diabetes, too. Research presented Monday at a large diabetes meeting showed some promise for this approach.
    • “Patients who took a GLP-1 drug fared better than those in a control group at keeping their blood glucose levels in a healthy range while also losing more weight than those who weren’t taking the drug.”
  • Per BioPharma Dive,
    • “One of the most closely watched clinical trials in the burgeoning field of psychedelics research has delivered results that, while positive, appear to have unnerved some investors.
    • “Sponsored by U.K.-based biotechnology company Compass Pathways, the trial enrolled 258 people with treatment-resistant depression. Participants were given either a placebo or the company’s proprietary version of psilocybin — a psychedelic compound found in many mushroom species — and evaluated for an initial period of six weeks.
    • “According to Compass, a single dose of its drug significantly reduced scores on a 60-point scale that healthcare providers use to gauge depressive symptoms.”
    • The article explains why investors were not impressed by these results.

From the U.S. healthcare business front,

  • Fierce Healthcare discusses the top ten nonprofit health systems by 2024 operating revenue, and points out
    • “Despite an uncertain regulatory environment and higher hold period for investments in healthcare, deal volumes remain steady.
    • “So says a new report from PwC. In addition to regulatory scrutiny, persisting valuation gaps between buyers and sellers have contributed to hesitation in the market. Nonetheless, deals continue to pace significantly ahead of pre-COVID levels—though are down from the boom years of 2020 to 2022. The three-year running average of the number of healthcare transactions weighs in at 1,375. 
    • “The subsector leading with the most deals (454) in the last 12 months was a group of services that includes contract research organizations, ambulatory surgical centers, home infusion care and medical office buildings. These deals represented more than $31 billion in value. In second place were physician groups (413 deals totaling $11.3 billion) followed by labs and diagnostics (110 deals worth $7.6 billion).”
  • and
    • “Concern about the cost of GLP-1s remains high, and a new study suggests it’s not uncommon for patients to overpay for these drugs.
    • “E-prescribing company DoseSpot released a study Monday that analyzed more than 100,000 prescriptions for GLP-1s and found they likely overpaid by a collective $10.2 million. Most (92%) of prescriptions included at the study could have been obtained at a lower price.
    • “The data were provided exclusively to Fierce Healthcare. The report said that the $10.2 million in savings extrapolated across the approximately 32 million individuals who currently take GLP-1 ones mean there’s an opportunity here for potentially billions in savings.
    • “The bulk of the savings identified in the study, or about $7 million, would have been generated by being in one of the manufacturers’ savings programs. Josh Weiner, CEO of DoseSpot, told Fierce Healthcare in an interview that stakeholders can do more to keep providers in the loop about what patients may be eligible for.”
  • The Wall Street Journal reports,
    • “Novo Nordisk ended its partnership with Hims & Hers, accusing it of illegally selling copycats of Wegovy and deceptive marketing.
    • “Hims & Hers accused Novo Nordisk of pressuring it to steer patients to Wegovy, regardless of whether it was the best option.
    • “Hims & Hers’ shares dropped after the deal was scrapped. Novo Nordisk will continue to make Wegovy available via telehealth.”
  • Beckers Health IT takes a look at Google Healthcare’s moves.
  • Per Healthcare Dive,
    • “Ohio’s attorney general has conditionally approved venture capital firm General Catalyst’s acquisition of Summa Health, according to a press release Wednesday. 
    • “General Catalyst’s Health Assurance Transformation subsidiary, or HATCo, and the Akron, Ohio-based health system must meet 10 conditions to allow the deal to move forward, including increasing the purchase price by $15 million in cash and an additional $15 million in equity to the surviving nonprofit foundation, according to a letter sent by Attorney General Dave Yost’s office. The equity interest can’t be sold for three years. 
    • “HATCo will also have to file a yearly report with the attorney general to show it’s complying with post-closing obligations, as well as provide notice of new deals that could trigger antitrust concerns.”
  • Per MedTech Dive,
    • “Illumina said Monday it agreed to acquire SomaLogic and other assets from Standard BioTools for $350 million in cash to expand in the proteomics market.
    • “The deal includes additional near-term payments of up to $75 million tied to performance milestones, plus royalties.
    • “Illumina said the acquisition of SomaLogic, a leader in data-driven technology, will advance the company’s multiomics strategy and strengthen the value of its NovaSeq X products.
    • “Illumina and SomaLogic have partnered closely for more than three years, and this combination increases our ability to serve our customers and accelerate our technology roadmap towards advanced biomarker discovery and disease profiling,” Illumina CEO Jacob Thaysen said in a statement.”

Friday report

David Ermer–ACA, CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, Telehealth–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us,
    • “On Thursday night, the Senate Homeland Security and Governmental Affairs Committee published its portion of the budget reconciliation bill, which aims to cut federal spending to partially pay for tax cuts for the wealthy and increased immigration enforcement.
    • “Gone from the bill are House-passed provisions that would require all federal workers to contribute 4.4% of their basic pay toward the Federal Employees Retirement System, reduce their FERS benefit calculation from the average highest three years of salary to the highest five years, and eliminate the FERS supplement for employees who retire before Social Security kicks in at age 62.
    • “But in their place is a more draconian iteration of the controversial plan to force future federal workers to choose between a more expensive defined benefit annuity and at-will employment, meaning they can be fired “for good cause, bad cause, or no cause at all.” Under the Senate plan, all new federal hires would pay more than double toward FERS compared to feds hired after 2014—9.4% of their basic pay—and those who elect to accrue civil service protections would pay an additional 5 percentage points on top of that, or 14.4% of basic pay.”
  • Federal News Network adds,
    • “The Trump administration would proceed with plans to downsize the federal workforce and reorganize agencies with minimal interference from Congress, under a Senate committee’s proposal.
    • “The Senate Homeland Security and Governmental Affairs Committee, in its contribution to the budget reconciliation package, would allow the Trump administration to proceed with sweeping changes to the federal workforce — including those currently stalled by federal judges — without approval from Congress.
    • “The committee’s section of the “One Big, Beautiful Bill,” which passed the House last month, also sets aside $100 million for the Office of Management and Budget to oversee and implement the Trump administration’s reorganization plans over the next decade.”
  • Fierce Pharma lets us know,
    • “Independent Sens. Bernie Sanders of Vermont and Angus King of Maine have introduced a bill that would ban pharmaceutical companies from advertising directly to consumers.
    • “The End Prescription Drug Ads Now Act would prevent drugmakers from promoting prescription drugs through television, radio, print, digital platforms and social media.” * * *
    • “The proposal is likely to receive support from the Trump administration.” 
  • KFF released a report about “ACIP, CDC, and Insurance Coverage of Vaccines in the United States.”
  • The Sequoia Blog notes,
    • Recent guidance from the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), and the United State Preventive Services Task Force (USPSTF) will impact coverage for women that must be provided by group health plans at no-cost, explained further [in the blog post].
  • Radiology Business adds,
    • “Radiology Partners was the No. 1 initiator of No Surprises Act payment disputes in the second half of 2024 with 136,784, according to new data released Wednesday. 
    • “The El Segundo, California-based industry giant accounted for about 15% of all disputes in Q4 of 2024 and 18% in Q3. HaloMD, a San Antonio, Texas, firm specializing in NSA dispute resolutions, was No. 2, initiating 134,318, followed by Knoxville, Tennessee, multispecialty group TeamHealth with 94,598. 
    • “In a summary document, the Centers for Medicare & Medicaid Services highlighted the “high volume of disputes” handled between July 1 and Dec. 31, 2024. Provider groups such as Rad Partners initiated a total of 853,374 disputes through the federal independent dispute resolution (IDR) portal, up 40% from the first half of 2024. Across all of last year, a small number of organizations were responsible for the majority of disputes, CMS noted.
    • “Many of the top initiating parties are (or are represented by) large practice management companies, medical practices or revenue cycle management companies representing hundreds of individual practices, providers or facilities,” the agency said May 28. “The top three initiating parties (Radiology Partners, HaloMD, and TeamHealth) represent thousands of clinicians across multiple states and accounted for approximately 43% of all disputes initiated in the last six months of 2024.”
  • STAT News points out,
    • “The links between ultra-processed food and higher risk of diabetes will be the focus of the first wave of health secretary Robert F. Kennedy Jr.’s national “Take Back Your Health” campaign, according to a notice posted on a government site for contractors.
    • “The notice invites public relations agencies to pitch strategies for the launch of the ad campaign, “a wake-up call to Americans that eating processed foods dramatically increases the risk of diabetes and chronic disease.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “The FDA has approved Moderna’s mRESVIA for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults ages 18 to 59 who are at an increased risk for severe disease.
    • “Back in May, mRESVIA scored an FDA approval in adults 60 and older, becoming Moderna’s second commercial product behind the company’s first-generation COVID-19 shot, Spikevax.”
  • and
    • “Despite a recent rebuff from an FDA advisory committee, the first treatment for a specific and underserved cohort of U.S. bladder cancer patients has crossed the FDA finish line as UroGen Pharma’s Zusduri.
    • “The New Jersey-based pharma paired chemotherapy mitomycin with a sterile hydrogel using its sustained-release RTGel technology to create a localized therapy for potent tumor ablation of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). It’s a drug delivery combo familiar to UroGen from its 2020 approved Jelmyto, another hydrogel and mitomycin pairing formulated as a liquid solution made for delivery in the kidney’s pyelocalyceal system that is indicated for low-grade upper tract urothelial cancer.”
    • “In its phase 3 ENVISION trial, UroGen found that Zusduri could deliver a 78% complete response for patients with LG-IR-NMIBC at three months, with 79% of those patients still event-free 12 months later.”

From the judicial front,

  • The Wall Street Journal reports,
    • “Anne Wojcicki, the co-founder and former CEO of 23andMe, is poised to regain control of the DNA-testing company after a nonprofit she controls topped a prior bid.
    • “23andMe said Friday that a nonprofit backed by Wojcicki was the new buyer for the company’s assets, offering $305 million.
    • “Last month, 23andMe said Regeneron, a biotech based in Tarrytown, N.Y., had won the bidding during a bankruptcy auction to buy the company for $256 million. 
    • “The bidding reopened early this month, after Wojcicki, through her nonprofit, TTAM Research Institute, made the unsolicited offer. TTAM is an acronym that aligns with the first letters of 23andMe.
    • “Regeneron declined to make a bid that topped TTAM’s offer, which is being financed by Wojcicki and her affiliated entities, according to a court filing. The TTAM bid still needs to be approved by the court.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Reported on Friday, June 13, 2025
    • Seasonal influenza activity is low. COVID-19 and RSV activity is very low.
    • COVID-19
      • COVID-19 wastewater activity, emergency department visits, and laboratory percent positivity are at very low levels.
    • Influenza
    • RSV
      • RSV activity is very low.
  • The University of Minnesota’s CIDRAP adds,
    • Dozens of medical and public health organizations have signed a letter urging insurers to continue covering COVID-19 vaccination in pregnant patients.
    • The letter from the American College of Obstetricians and Gynecologists is in response to the recent move by the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) to no longer recommend COVID-19 shots for healthy pregnant women.
  • and
    • “In its latest update on variant proportion estimates, the US Centers for Disease Control and Prevention (CDC) said the level of NB.1.8.1 viruses, recently added as a variant under monitoring (VUM) by the World Health Organization (WHO), has grown from 15% to 37% since late May, bringing it nearly even with LP.8.1, which has been dominant over the last few months.” * * *
    • “The CDC also reported a rise in XFG variant proportions, which rose from 6% to 8% over the same period. Both viruses are descendants of the JN.1 Omicron SARS-CoV-2 variant.”
  • and
    • “The US Centers for Disease Control and Prevention (CDC) today in its weekly measles update reported 29 more cases, bringing the national total to 1,197 cases and coming within 77 cases of matching the total from 2019, which was the most since the disease was eliminated from the country in 2000.
    • “So far, 35 states have reported cases, one more than a week ago, which likely reflects Arizona’s first cases of the year.
    • “Four more outbreaks were reported, bringing the national total to 21. For comparison, the CDC recorded 16 outbreaks for all of 2024. Of measles cases reported this year, 90% have been part of outbreaks. Last year, 69% of the illnesses were related to outbreaks.
    • “School-aged children are the most affected group (37%), followed closely by adults ages 20 and older (33%), and children younger than 5 years old (29%).”
  • The AHA New relates,
    • “The Centers for Disease Control and Prevention has added new resources for health care providers to its Be Ready for Measles Toolkit. They include a decision tree to help providers determine when to give measles, mumps and rubella vaccinations to adults; checklists for summer camps; and immunity records templates.” 
  • CBS News reports,
    • “The average age of moms giving birth in the U.S. continues to rise, hitting nearly 30 years old in 2023, according to a new report from the Centers for Disease Control and Prevention.
    • “In the report, published Friday by the CDC’s National Center for Health Statistics, researchers found the average age of all mothers giving birth in the United States increased from 28.7 years old in 2016 to 29.6 in 2023. For new first-time moms, average age also increased, from 26.6 in 2016 to 27.5 in 2023. The data was taken from the National Vital Statistics System, which includes all birth records in the country.” 
  • The New York Times reports, “In Some Ozempic Households, the Weight Loss Is Contagious. Patients taking the drugs are finding their families are benefiting, too.”
  • Managed Healthcare Executive adds,
    • “Glucagon-like peptide-1 receptor agonists (GLP-1RAs) — a class of drugs typically prescribed for type 2 diabetes and weight loss — may significantly reduce the risk of developing several common age-related eye diseases, including age-related macular degeneration (AMD) and glaucoma, according to a study published online earlier this year in Ophthalmology.
    • “The study, based on an analysis of electronic health records (EHRs) from older patients in the United States, revealed that GLP-1RAs were associated with lower rates of age-related macular degeneration, as well as primary open-angle glaucoma (POAG), when compared with other common medications such as metformin, insulin, statins and aspirin.”
  • Per MedPage Today,
    • Starting fecal immunochemical testing (FIT) at ages 40 to 49 was associated with reduced colorectal cancer (CRC) incidence and mortality compared with starting screening at age 50, a Taiwanese cohort study suggested.
    • Among over 263,000 participants, the incidence of CRC was 26.1 per 100,000 person-years for those who participated in early screening (at ages 40 to 49) versus 42.6 per 100,000 person-years for those who participated in regular screening (at age 50 and older), reported Tony Hsiu-Hsi Chen, PhD, of National Taiwan University in Taipei, and colleagues.
    • The mortality rate was 3.2 per 100,000 person-years for the early screening group compared with 7.4 per 100,000 person-years for the regular screening group, they noted in JAMA Oncology.
  • Per Health Day,
    • “A good number of people don’t know that high blood pressure is a silent killer, increasing a person’s heart risk with no obvious symptoms, a new poll has found.
    • “More than a third of Americans (37%) erroneously think high blood pressure always has noticeable symptoms like dizziness or shortness of breath, according to a survey by the University of Pennsylvania’s Annenberg Public Policy Center.
    • “In truth, high blood pressure usually has no signs or symptoms to indicate its presence, according to the U.S. Centers for Disease Control and Prevention (CDC).
    • “Likewise, nearly 4 in 10 people (39%) mistakenly believe that “feeling calm and relaxed” is an indication that blood pressure is normal, the poll shows.
    • “And very few people — only 13% — know the correct reading that reflects high blood pressure, 130/80, poll results show.
    • “Because controlling blood pressure reduces one’s risk of serious health problems, including heart attacks and strokes, correcting misperceptions about ways to identify it should be a public health priority,” Patrick Jamieson, director of the policy center’s Annenberg Health and Risk Communication Institute, said in a news release.”

From the healthcare business front,

  • The Wall Street Journal reports,
    • “AstraZeneca said it entered into a strategic research collaboration with China’s CSPC Pharmaceuticals, focused on artificial intelligence-driven research, valued at up to $5.33 billion.
    • “The partnership aims to advance the discovery and development of novel oral candidates, with the potential to treat diseases across multiple indications, the British pharmaceutical giant said Friday.
    • “Under the terms of the deal, CSPC will receive an upfront payment of $110 million. It is also eligible to receive up to $1.62 billion in potential development milestone payments and up to $3.6 billion in sales milestone payments, as well as potential single digit royalties based on annual net sales of the products.
    • “The British group will have rights to exercise options for exclusive licenses to develop and commercialize worldwide candidates identified under the agreement.
    • “The research will be carried out by CSPC and will utilize its AI-driven technology.
    • “The collaboration boosts AstraZeneca’s presence in China following the $2.5 billion investment in the country announced earlier this year, while it also strengthens its collaboration with the Chinese group.”
  • Modern Healthcare reports,
    • “Amazon is restructuring its healthcare division and another high-profile executive is departing the company.
    • “As part of the restructuring, Amazon’s Vice President of Health Partnerships and Marketing Aaron Martin is planning to leave the company later this summer after assisting with the transition, according to a person familiar with the situation.
    • “The moves were made to simplify the company’s structure, reduce layers and elevate tenured leaders across six teams, said Neil Lindsay, senior vice president at Amazon Health Services, in a statement on Friday. 
    • “Two of Amazon’s healthcare teams will focus on Amazon’s One Medical virtual and in-person care product, with one focused on clinical care delivery while the other is centered on operations and performance. The four other teams will focus on pharmacy, growth and network development, compliance as well as a segment focused on marketing and technology.”
  • Medscape tells us,
    • “Hospitals are struggling with long emergency room (ER) wait times, capacity issues, and staffing shortages. A growing number of patients with cellulitis, chronic obstructive pulmonary disorder, pneumonia, and other chronic conditions are being asked to skip hospital stays and return home.
    • “Hospital at Home models may be the answer. The explosion of Hospital at Home programs now makes it possible to provide acute level care at home. Today, 378 hospitals in 140 health systems and 39 states have been approved to provide healthcare at home. And a recent report found that 71% of health systems planned to launch Hospital at Home models.
    • “Digital care is the way of the future,” said Melissa Meier, MSN, RN, manager of Digital Care for OSF OnCall, the Digital Health Division for OSF HealthCare in Peoria, Illinois. “We’re always looking at ways to help reach more patients [and] always being on the cutting edge to reach our patients wherever they are is super important…[Hospital at Home] is certainly an answer for that.”
  • Per Beckers Hospital Review,
    • Becker’s has compiled a list of the hospitals with a CMS five-star rating for care transitions.
    • CMS’ “Patient survey (HCAHPS)-Hospital” database listed hospital ratings based on the Hospital Consumer Assessment of Healthcare Providers and Systems survey. This is a national, standardized survey of hospital patients about their experience during a recent inpatient hospital stay. The survey was completed between July 2023 and June 2024. The data was last updated April 30. 
    • [The article lists] the 195 hospitals by state with five-star care transition ratings.
  • Per BioPharma Dive,
    • “Quest Diagnostics has partnered with The University of Texas MD Anderson Cancer Center to develop a cancer risk blood test.
    • “The collaboration, which Quest disclosed Tuesday, builds on MD Anderson’s research into protein biomarkers that may indicate a patient is at high risk of cancer diagnosis in the coming years.
    • “MD Anderson’s approach is potentially a cheaper way than liquid biopsies to find patients who would benefit from conventional screening, according to the announcement. Quest is aiming to launch the test next year.”
  • and
    • “Novo Nordisk is planning Phase 3 clinical trials for a obesity drug combination called amycretin, adding another emerging weight-loss medicine to the list of prospects it has in advanced testing.
    • “The Danish drugmaker said Thursday the trials could begin in early 2026 and will test both an injectable and an oral formulation. In a Phase 2 trial, amycretin helped people with obesity lose up to 22% of their body weight over 36 weeks, topping Novo’s marketed medication Wegovy as well as Eli Lilly’s rival Zepbound.
    • “Amycretin targets GLP-1, as Wegovy does, but also a separate metabolic hormone called amylin that has drawn increasing interest from drugmakers. Earlier this week, shares of Metsera climbed by double digits after the biotechnology company reported promising Phase 1 data for an amylin-targeting agent.”