Friday report

Mental health care

Friday report

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

From Washington, DC,

  • Govexec reports,
    • “President Trump created another new category of federal employee on Thursday evening, issuing an executive order to expand the number of political appointees who do not require Senate confirmation and will serve in policy-making or policy-advocating roles. 
    • ‘While presidents can already tap an uncapped number of appointees to serve in Schedule C positions, Trump noted those individuals serve in more narrow confidential or policy-determining roles. The new positions will therefore fill a gap that currently exists in federal appointments, the White House said. 
    • “The order is the latest in Trump’s effort to establish a tighter grip on the executive branch and its actions. He has already created Schedule Policy/Career, formerly known as Schedule F, which is similarly defined to Schedule G but reserved for career civil servants. Agencies are in the process of determining who qualifies for conversion to Schedule Policy/Career and those employees will become easier to fire for any reason.” 
  • Federal News Network tells us,
    • “The Postal Service’s new chief executive is defending the agency’s current operating model, at a time when the Trump administration considers challenging its independence.
    • “David Steiner, former FedEx board member and Waste Management CEO, began his tenure as postmaster general on Tuesday.
    • “Steiner told employees Thursday he supports keeping USPS independent from the executive branch and defended the 10-year reform plan of his predecessor, former Postmaster General Louis DeJoy.
    • “Steiner told employees in a video message on Thursday that, “I do not believe that the Postal Service should be privatized, or that it should become an appropriated part of the federal government.”
    • “I believe in the current structure of the Postal Service as a self-financing, independent entity of the executive branch,” Steiner said. “My goal for the Postal Service is to meet the financial and service performance expectations of our nation under this structure.”
  • The American Hospital Association News informs us,
    • “Health Insurance Marketplace insurers will propose a median premium increase of 15% for 2026, according to an analysis of preliminary rate filings published July 18 by the Peterson Center on Healthcare and KFF. It would be the largest hike in premiums since 2018, the report said. Factors cited for the increase include the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The analysis found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase the cost of certain drugs, medical equipment and supplies.”
  • The Centers for Medicare and Medicaid Services shares highlights from its 2025 Quality Conference held earlier this month.
  • KFF, writing in Fierce Healthcare, criticizes the No Surprises Act. No law is perfect.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive.
    • “Sarepta last month paused shipments for certain older Duchenne patients following the death from acute liver failure of a second teenager treated with the therapy, called Elevidys. The FDA subsequently began a formal investigation of Elevidys’ liver risks. 
    • “Reuters first reported news of the FDA’s request. FDA Commissioner Martin Makary told Bloomberg in an interview Friday that his agency is weighing whether to withdraw Elevidys from the market entirely. 
    • “The news comes on the heels of Sarepta reporting this week the death of a 51-year-old man who received an experimental gene therapy it’s developing for another kind of muscular dystrophy known as limb-girdle. The man died of complications from acute liver failure in June. 
    • “While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles.”
  • The New York Times adds,
    • In a remarkable public dispute between drugmaker and regulator, the biotech company Sarepta Therapeutics is defying the Food and Drug Administration’s request that it halt distribution of its treatment for a deadly muscle-wasting disease.
    • In a news release on Friday evening, the agency said that it requested that the company voluntarily stop all shipments of the therapy, known as Ele­vidys, citing the deaths of three patients from liver failure who had taken the product or a similar therapy.
    • In its own news release later on Friday evening, Sarepta, which is based in Cambridge, Mass., said that it would continue to ship the treatment for patients who do not use wheelchairs. The company said its analysis showed no new safety problems in those patients and that it was committed to patient safety.
  • BioPharma Dive points out,
    • “A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a meeting convened Thursday by the Food and Drug Administration.
    • “Led by FDA Commissioner Martin Makary, the meeting focused on the benefits and risks of menopause hormone therapy, or MHT, which has become a controversial topic due to mixed study data.
    • “The panel, which consisted of 12 experts with various medical backgrounds, took a generally positive view of MHT and described situations in which patients experienced severe symptoms could not get access to treatment.”
  • Healthexec notes,
    • “The U.S. Food and Drug Administration announced a recall of multiple active glucose monitoring units manufactured by Dexcom due to a malfunction in the receivers. The speakers on these devices may fail to alert wearers when blood sugar levels become dangerously high or low. Typically, the monitors emit an alert sound; however, in Dexcom G6, G7, ONE and ONE+ products, reports indicate that the alarms do not always function properly.
    • “There have been at least 56 injuries associated with the error, the FDA said. However, no deaths have been reported.”
  • Reuters adds,
    • “The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK’s (GSK.L)  blockbuster shingles vaccine Shingrix, providing patients a more convenient option to receive the shot, the company said on Thursday.”

From the judicial front,

  • Healthcare Dive reports,
    • “A Texas federal judge has dismissed Humana’s lawsuit against the federal government seeking to improve its Medicare Advantage star ratings, in a significant loss for the insurer.
    • “Humana sued the CMS in October 2024 to reverse its quality scores, arguing that the agency acted arbitrarily and capriciously in downgrading the ratings, which are tied to billions of dollars in reimbursement, for 2025.
    • “However, District Judge Reed O’Connor ruled on Friday that Humana failed to exhaust administrative remedies before filing its lawsuit. Humana said it is exploring further legal action.”
  • Bloomberg Law lets us know,
    • “A federal judge refused Friday to remove an order that halted US Health Secretary Robert F. Kennedy Jr. from carrying out mass firings and restructuring across health agencies. 
    • “The US District Court for the District of Rhode Island disagreed with the Justice Department’s request to lift the order due to pending stays in two other cases that challenge with government’s reduction-in-force. Those cases are McMahon v. New York , regarding layoffs at the Department of Education, and Trump v. AFGE, regarding President Donald Trump’s reorganization of the federal government.” * * *
    • “Defendants misguidedly argue that the Supreme Court’s recent grants of stays pending appeals” in those cases mean that the court should immediately reverse its July 1 decision granting plaintiffs’ preliminary injunction, Judge Melissa R. DuBose for the US District Court for the District of Rhode Island said in the order. * * *
    • “DuBose rejected the government’s request to stay pending the appeal.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many Southeast, Southern, and West Coast states. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among young children 0-4 years old. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in many Southeast, Southern, and West Coast states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP tells us,
    • “Only 35% to 40% of US pregnant women and parents of young children say they intend to fully vaccinate their child, per survey results from researchers at Emory University and the Centers for Disease Control and Prevention (CDC).
    • “For the two surveys, published as a research letter this week in JAMA Network Open, the investigators recruited 174 pregnant women and 1,765 parents from a nationally representative panel in April 2024 to answer questions about their intent to have their child receive all recommended vaccines by 18 months.
    • “Many parents in the US choose to delay or refuse vaccines that are recommended for their child from birth to age 18 months,” the study authors wrote. “Research is necessary to understand the value of intervening during pregnancy to proactively support parents with vaccination decisions before the birth of the child, as implementation of such interventions will require substantial engagement of health care professionals and entities outside of the pediatric care setting.”
  • Per an NIH news release,
    • “Sjögren’s disease is a chronic autoimmune condition affecting up to four million Americans, characterized by symptoms such as dry eyes and mouth, fatigue, and inflammation in various organs. Although it primarily affects women, men tend to face more severe complications. The disease can impact pregnancy outcomes and increase risk for lymphoma. Despite extensive research, its underlying causes remain unclear, and current treatments mainly aim to manage symptoms.
    • “Recent NIH-supported research using mouse models sheds new light on Sjögren’s disease, pointing to dysfunction in regulatory T cells and a heightened interferon gamma response as key drivers of disease symptoms. A drug called baricitinib, already approved for conditions such as rheumatoid arthritis, showed promising results in mice by reducing inflammation and restoring gland function. The similarities between mouse and human immune responses suggest that baricitinib could be a viable future treatment for people with Sjögren’s disease, offering hope for more targeted therapies ahead.”
  • The Washington Post reports,
    • “A baby’s sex may not be up to mere chance.
    • “A study published Friday in the journal Science Advances describes the odds of having a boy or girl as akin to flipping a weighted coin, unique to each family. It found evidence that an infant’s birth sex is associated with maternal age and specific genes.
    • “The findings challenge assumptions that birth sex is random. They mirror the results of similar studies in Europe that have also found that birth sex does not follow a simple 50-50 distribution.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Prescription drug denials by private insurers in the United States jumped 25 percent from 2016 to 2023, according to a new analysis of more than four billion claims, a practice that has contributed to rising public outrage about the nation’s private health insurance system.
    • “The report, compiled for The New York Times by the health analytics company Komodo Health, shows that denial rates rose from 18.3 percent to 22.9 percent. The rejections went up across many major health plans, including the country’s largest private insurer, UnitedHealthcare.” * * *
    • “The analysis found that the most common reason for a drug claim to be rejected was that a refill had been requested “too soon,” before the patient was eligible for more medication.”
    • “Appropriate prescription drug denials can happen for numerous reasons, and many can be resolved within minutes,” said Greg Lopes, a spokesman for the Pharmacy Care Management Association, a trade group for pharmacy benefit managers.”
  • Beckers Payers Issues gives us a look inside the Humana-Mercy partnership “that’s shaping the future of health care.”
  • Behavioral Health Business tells us,
    • “Lyra Health, a national provider of mental health benefits for employers, has acquired Bend Health with the goal of strengthening its pediatric and neurodiversity capabilities. 
    • “Lyra’s acquisition of Madison, Wisconsin-based Bend Health was completed July 16. Exact terms of the deal were not disclosed in the press release.
    • “The move enables Lyra to utilize Bend Health’s collaborative care model and specialized providers to offer more comprehensive evaluations and virtual intensive outpatient care to its 20 million members.”
  • NCQA, writing in LinkedIn, discusses a new look for HEDIS that will arrive on August 1.

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.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, Obesity, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Federal News Network informs us,
    • “Top Republicans on the House Education and Workforce Committee are pushing for an investigation into the long-standing workers’ compensation program for federal employees, saying the program is particularly “susceptible to waste, fraud and abuse.”
    • “In a letter to the Government Accountability Office on Monday, Committee Chairman Tim Walberg (R-Mich.) and Rep. Ryan Mackenzie (R-Pa.), chairman of the workforce protections subcommittee, requested a further examination into areas for reforms of the Federal Employees’ Compensation Act (FECA) program, which provides benefits to federal employees who get injured or become ill from work.
    • “In their letter, the GOP committee leaders argued that the program is “overly generous” to federal employees. The FECA program, which dates back to 1916, hasn’t seen any major updates in over 50 years.” * * *
    • “This year, bipartisan lawmakers have also been attempting to reform the FECA program through the “Improving Access to Workers’ Compensation for Injured Federal Workers Act.” If enacted, the legislation would revise FECA to allow physician assistants and nurse practitioners to treat federal employees in workers’ compensation cases — something that is currently prohibited by law.”
  • Per a Centers for Medicare and Medicaid Services news release,
  • Beckers Hospital Review shares highlights from the proposed rule.
  • Bloomberg Law reports,
    • “The US Department of Health and Human Services officially laid off employees on Monday, following an order from the Supreme Court on July 8 that allowed its restructuring plans to proceed, according to emails viewed by Bloomberg. 
    • “Many employees who were supposed to be released during the agency’s first round of 10,000 layoffs in April have been in limbo as the effort made its way through the court system and was paused by federal judges. The reorganization, in addition to cutting staff, was supposed to consolidate the department’s 28 divisions into 15 and cut regional offices from 10 to five.” 
  • KFF issued an analysis of the Competitiveness of Medicare Advantage Markets.
    • “The average beneficiary has access to 34 Medicare Advantage plans with prescription drug coverage in 2025, double the number available in 2018. However, recent analysis suggests that Medicare Advantage markets are highly concentrated, with only a few firms accounting for the lion’s share of enrollment.
    • “Among other key takeaways, the new analysis finds that nine in ten (90%) Medicare beneficiaries lived in a county where at least half of all Medicare Advantage enrollees were in plans sponsored by one or two insurers in 2024. Medicare Advantage markets were more concentrated in rural counties than in urban counties. Among insurers, UnitedHealthcare  or Humana had the highest enrollment in two-thirds of counties in 2024.”
  • and an analysis of the 988 Suicide & Crisis Lifeline Data on the Third Anniversary of the National Hotline.
    • “The 988 service has received 16.5 million contacts since its launch in July 2022, including 11.1 million calls, 2.9 million texts, and 2.4 million chats. Monthly contact volume has steadily increased, consistently surpassing 500,000 contacts per month over the past year and approaching or exceeding 600,000 per month since early 2025—more than double the contacts recorded just before launch (277,000 in June 2022).
    • “Most states now answer 80% or more of 988 calls in-state, a significant improvement compared to before 988’s launch. In-state answer rates in May 2025 ranged from 58% in Arkansas to 99% in Rhode Island. Calls not answered in-state are redirected to national backup centers, where counselors may be less familiar with local resources. 
    • “The overall number of suicide deaths remained stable from 2022 to 2023 (49,476 to 49,316), according to the latest data available from the CDC. Provisional CDC data suggest this stabilization may have continued into 2024 (48,796). It is too soon to fully determine the impact of 988.” 
  • The American Hospital Association (AHA) News tells us,
    • The AHA today responded to a Department of Health and Human Services request for information regarding lawful regulation and innovation to promote better health. The AHA said it agreed with HHS’ stance that reducing unnecessary administrative burden could foster improved health, and highlighted recommendations on deregulation opportunities relevant for hospitals and health systems to address chronic disease. The AHA made initial recommendations that included reducing administrative and coverage barriers to care, advancing the sustainable adoption of technology and innovation, facilitating whole-person care and sustaining the health care workforce. The AHA also shared a comprehensive list of 100 ways to free hospitals from burdensome administrative requirements and highlighted a report of programs across all 50 states to demonstrate the critical work hospitals do daily to combat chronic illness.

From the Food and Drug Administration (FDA) front,

  • From an FDA news release,
    • “Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice. It is the fourth color derived from natural sources approved by the FDA for use in foods in the last two months.”
    • * * * In addition to approving a new color additive, the FDA also announced today that it had sent a letter to manufacturers encouraging them to accelerate the phase-out of FD&C Red No. 3 in foods, including dietary supplements, sooner than the January 15, 2027, required deadline. This earlier phase-out was another of the series of measures introduced by Secretary Kennedy in April. * * *
    • “On Friday, July 11, Consumer Brands—a national trade association for manufacturers of consumer-packaged goods—announced their voluntary commitment to encourage the makers of America’s food and beverage products to remove certified Food, Drug & Cosmetic (FD&C) colors from products served in schools nationwide by the start of the 2026–2027 school year.”
  • Fierce Pharma notes,
    • “The use of SGLT2 inhibitors has been a game-changer in the treatment of heart failure (HF). Now, another drug class has reached the market that could further alter the HF landscape.
    • “The FDA has expanded the label of Bayer’s Kerendia, a nonsteroidal selective mineralocorticoid receptor antagonist (MRA), to include treatment of patients with two types of heart failure. Kerendia can now be used by HF patients with either preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF).
    • “The U.S. regulator originally approved Kerendia four years ago to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes.
    • The new nod allows Kerendia to be given to HF patients who do not have CKD linked to type 2 diabetes.

From the judicial front,

  • Federal News Network tells us,
    • “The Supreme Court is allowing President Donald Trump to put his plan to dismantle the Education Department back on track — and to go through with laying off nearly 1,400 employees.
    • “With the three liberal justices in dissent, the court on Monday paused an order from U.S. District Judge Myong Joun in Boston, who issued a preliminary injunction reversing the layoffs and calling into question the broader plan. The layoffs “will likely cripple the department,” Joun wrote. A federal appeals court refused to put the order on hold while the administration appealed.
    • “The high court action enables the administration to resume work on winding down the department, one of Trump’s biggest campaign promises.”
  • The AHA News points out,
    • “The U.S. District Court for the Eastern District of Texas July 11 vacated a rule issued by the previous administration that would have banned medical bills from appearing on credit reports and prohibited lenders from using medical information in lending decisions. U.S. District Judge Sean Jordan said in the order that the rule exceeded the authority of the Consumer Financial Protection Bureau and violates the Fair Credit Reporting Act.”
  • and
    • “The U.S. District Court for the Eastern District of Missouri July 11 granted a motion by the state to dismiss claims by AbbVie that the state’s 340B contract pharmacy law is invalid and should not be enforced. The Missouri law prohibits drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. The court found that AbbVie lacked standing to bring action against the state where the injuries alleged in its complaint were attributable to the federal 340B statute — not the state law.”

From the public health and medical research front,

  • GoodRx offers insights into signs of colon cancer.
    • “Changes in stool shape or blood in stool may suggest colon cancer. But most people with colon cancer do not have symptoms.
    • “Screening for colon cancer is important whether or not you have changes in your stool. Talk with your provider about when and how you should get screened.
    • “In its early stages, colon cancer is preventable and treatable. This is why early detection through regular screening or at the first sign of symptoms is important.”
  • The American Medical News tells us what doctors wish their patients knew about “water warts.”
    • “Molluscum contagiosum, more commonly known as “water warts,” is a highly contagious skin infection caused by a poxvirus. While the condition is generally harmless, its persistent and sometimes unsightly lesions can cause anxiety and confusion for families. Becoming familiar with the signs, symptoms and best practices for preventing the spread of this surprisingly common viral skin infection is key.”
  • Per the AHA News,
    • “To help hospitals across the country improve sepsis care, the Centers for Disease Control and Prevention created the Hospital Sepsis Program Core Elements, consisting of seven strategies designed to enhance early detection and treatment. The AHA’s Living Learning Network recently visited Ochsner Health, a system at the forefront of implementing this framework, highlighting how leadership, systemwide coordination and team-based practices are improving sepsis outcomes. LEARN MORE” 
  • BioPharma Dive reports,
    • “A new kind of sleeplessness medicine developed by Takeda met its goals in late-stage testing, positioning the company to capitalize on what Wall Street analysts believe could be a multibillion-dollar market opportunity.
    • “The drug, formerly known as TAK-861 but now called oveporexton, was evaluated in two Phase 3 studies in a main type of narcolepsy. According to Takeda, oveporexton hit every main and secondary trial endpoint, helping improve patient-reported scores on measures of wakefulness, excessive daytime sleepiness, muscle weakness, and other symptoms after 12 weeks of treatment.”
  • and
    • “An experimental drug being developed by AstraZeneca significantly reduced blood pressure versus placebo in a Phase 3 study of people with either uncontrolled or treatment-resistant hypertension, the pharmaceutical firm said Monday.
    • “The reduction in mean seated systolic blood pressure associated with AstraZeneca’s drug was clinically meaningful, the company added. Called baxdrostat, the drug also met all of the study’s secondary endpoints and was “generally well tolerated.”
    • “AstraZeneca plans to share the trial data with health authorities around the world and will present detailed study findings at the European Society of Cardiology Congress next month.”
  • The Washington Post reports,
    • “Nearly a fifth of U.S. adults previously deemed “overweight” would be categorized as “obese” under a 2024 obesity classification framework, according to a new study published in Annals of Internal Medicine.
    • “Using the recent obesity framework, 18.8 percent of the adults who had previously been categorized as “overweight” now fit under the “obese” category, researchers said.
    • “Last year, the European Association for the Study of Obesity (EASO) released the framework, which incorporates fat mass’s effects on health in addition to body mass index (BMI).
    • “In the Annals of Internal Medicine study, researchers applied the framework to a representative sample of 44,030 U.S. adults ages 18 to 79, testing how the distribution of obesity compared with a traditional measure that uses BMI only.”
  • STAT New explains “how an elite rehab center is using GLP-1s to ‘obliterate’ all kinds of cravings.”
    • “In recent months, doctors at Caron Treatment Centers, an elite nonprofit rehab facility, have begun prescribing semaglutide to patients not to address obesity or diabetes but to help treat the addictions that brought them here in the first place.” * * *
    • “Caron is, without a doubt, in uncharted territory. While the medications show significant promise as addiction treatments, only a handful of clinical trials are underway to measure their ability to reduce substance use. Several are unlikely to publish results within the next two years.” 
    • “At this idyllic facility 70 miles outside Philadelphia, however, [Steve] Klein and two fellow doctors are bypassing the speculation and the slow-moving scientific enterprise. No program has so openly and aggressively touted GLP-1s as a means of treating substance use disorder. And while their operation is backed by limited clinical data, their own eyes are giving them more confidence day by day.” 
  • STAT News adds,
    • When anti-vaccine activists and others argue that the immunizations used to protect children from infectious diseases are risky, they often point to aluminum salts, a product added to many childhood vaccines to increase their effectiveness.
    • A new large study from Denmark directly counters those claims. After mining the vaccination and medical records of more than 1.2 million children over a 24-year period, researchers could see no evidence that exposure to aluminum in vaccines led to a statistically significant increase in a child’s risk of developing any of a wide variety of conditions that can be diagnosed in childhood, including asthma and autism.

From the U.S. healthcare business front,

  • MedTech Dive reports,
    • “Waters has agreed to combine with BD’s biosciences and diagnostic solutions business in a deal valued at about $17.5 billion, the companies said Monday. The combined company will continue to operate under the Waters name and retain its listing on the New York Stock Exchange.
    • “The BD business will be spun off generally tax-free to BD shareholders and simultaneously merged with a subsidiary of Waters, through a structure known as a Reverse Morris Trust. Waters CEO Udit Batra will lead the new entity, and Waters’ headquarters will remain in Milford, Massachusetts.
    • “The transaction doubles Waters’ total addressable market to about $40 billion, with an annual growth rate of 5% to 7%, according to the statement. Waters shares fell more than 11% to $313.66 in early NYSE trading on Monday, while BD shares were down about 1% at $174.12.”
  • and
    • “Zimmer Biomet said Monday that it plans to buy Monogram Technologies, an orthopedics company with a robot for knee replacement procedures, for about $177 million.
    • “Monogram’s mBôS robot received Food and Drug Administration clearance in March for total knee replacement surgeries. The system uses CT scans and AI navigation for orthopedic procedures.
    • “Monogram’s robot will be sold with Zimmer implants in early 2027, the companies said in the announcement. They expect the merger to close later this year, if approved by regulators and Monogram’s shareholders.” 
  • HR Dive informs us,
    • “Most U.S. employers are expected to maintain their salary budgets for 2026, with increases remaining flat at 3.5%, matching actual increases for 2025, according to a July 8 report from WTW, a global advisory firm.
    • “In a survey of more than 1,500 U.S. organizations, 3 in 5 said their salary budgets changed in the last pay cycle. While 53% reported no change in their anticipated and actual pay budgets for 2025, 31% projected lower salary increase budgets than last year.
    • “While top-line budgets are generally holding steady, the real shift is happening beneath the surface,” Brittany Innes, director of rewards data intelligence for WTW, said in a news release. “Organizations are being more deliberate about how they allocate pay, where they focus investment and what outcomes they expect to drive. Employers are no longer simply reacting to economic signals; they’re reimagining how to best support broader business goals despite uncertainty.”

Midweek Report

David Ermer–CDC, Congress, FDA, Medical / Rx research, Mental health care, OPM, SDOH, U.S. Healthcare–

From Washington, DC,

  • At 6:45 pm ET, the Senate confirmed by a 49-46 vote the President’s nomination of Scott Kupor to be Office of Personnel Management Director for a four-year term. The confirmation vote followed a 51-46 vote in favor of Mr. Kupor to close debate on his nomination. (Link to Govexec story) Congratulations and best wishes, Mr. Kupor.
  • Govexec tells us,
    • “President Donald Trump’s candidate to lead the Centers for Disease Control and Prevention advanced out of a Senate committee Wednesday following a party-line vote, moving her one step closer to confirmation.
    • “Susan Monarez’s nomination now goes to the floor, where she will likely secure the backing needed to officially take on the role of CDC director after garnering support from Republicans across the political spectrum during the committee’s 12-11 vote.
    • “Senate Majority Leader John Thune, R-S.D., will be in charge of scheduling that vote, though if it isn’t held during the next few weeks, Monarez will have to wait until after the chamber’s August recess.”
  • BioPharma Dive informs us,
    • “President Donald Trump is planning to introduce tariffs of 50% on copper imports and levies “at a very, very high rate, like 200%” on pharmaceutical products, he said at a cabinet meeting Tuesday.
    • “Trump indicated official announcements of the tariffs would come “very soon” but did not elaborate on an exact timeline. He did say, however, that the U.S. would give pharmaceutical importers at least a year to shift their strategies before the implementation of the levies.” * * *
    • “In a note to clients, Leerink Partners David Risinger wrote how the planned grace period is a “positive” for the sector, which has for years built up production capacity in countries like Ireland, Switzerland and the Netherlands. Many generic medicines and drug ingredients, meanwhile, are sourced from India and China.”

From the Food and Drug Administration front,

  • BioPharma Dive relates,
    • “The Food and Drug Administration has approved a modified dosing schedule for Eli Lilly’s Alzheimer’s disease drug Kisunla, permitting a smaller first dose and a more gradual increase that in clinical trials, reduced dangerous episodes of brain swelling, the company said Tuesday.
    • “That side effect, called ARIA, has made physicians reluctant to prescribe the drug and resulted in its use being blocked in some countries. The new dosing protocol will “aid healthcare professionals in evaluating appropriate treatment options for their patients,” said Brandy Matthews, Lilly’s vice president for Alzheimer’s medical affairs, in a statement.
    • “Approved in 2024, Kisunla was the third drug cleared by the FDA to slow Alzheimer’s progression by targeting toxic plaques of a protein called amyloid beta. Despite its potency, sales were only a modest $21 million in the first quarter of 2025.”
  • Mobihealth News points out,
    • “Mendaera, a robotics company, announced it has been granted FDA 510(k) clearance for Focalist, a handheld robotic system, which aims to combine handheld robotics with real-time imaging to enable clinicians to place needles with precision. 
    • “Mendaera said the system integrates robotics, ultrasound imaging and advanced software to make medical procedures more accessible. 
    • “Among Focalist’s features are touchscreen targeting, robotic needle positioning and continuous needle depth tracking, enabling a reproducible procedure experience.
    • “While needle placement is used for a variety of procedures and in a broad range of clinical settings, the initial focus of the system will be in urology. Full commercialization is expected in 2026.”
  • Per Fierce BioTech,
    • “The FDA has cleared its first cuffless blood pressure monitor that will be available over-the-counter, with the Hilo wristband developed by Aktiia. 
    • “According to the Swiss company, the wearable’s optical sensors can capture continuous blood pressure readings similar to the traditional inflated cuff with monthly calibrations, and they have demonstrated accuracy across a variety of skin tones—as well as while the user is sitting, standing or lying down. 
    • “The system previously obtained a CE Mark approval in Europe, and Aktiia said its newly 510(k)-cleared product will reach the U.S. sometime in 2026. The Hilo bracelet has also been given go-aheads in Canada, Australia and Saudi Arabia, and more than 120,000 have already been sold, the company said.
    • “This is not just a regulatory win: it’s the start of a paradigm shift in hypertension management,” Aktiia’s co-founder and chief technology officer, Josep Sola, said in a statement. “With FDA’s OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The US Centers for Disease Control and Prevention (CDC) today reported 21 more measles cases from the past week, pushing the year’s total above a record set in 2019 for the most cases since the disease was eliminated in the United States in 2000.
    • “So far this year, 1,288 cases have been reported from 39 states, and 88% have been part of 27 outbreaks. Among confirmed cases, 92% occurred in people who are unvaccinated or have unknown vaccination status. 
    • “Measles isn’t just striking young children and their school-age peers: about one-third of cases have been reported in those ages 20 and older. The measles surge was initially fueled by a large outbreak in West Texas that began in January, but smaller outbreaks have now been reported from multiple states, along with numerous infections in unvaccinated people who traveled abroad.
    • ‘Measles activity has increased globally, including in North America, where the virus is spreading in communities with large numbers of unvaccinated people—including Mennonite communities linked to large outbreaks in the United States, Canada, and Mexico. Canada has reported 3,703 measles cases this year, the most since it eliminated the disease in 1998.”
  • and
    • “A study of more than 70,000 US pregnancies suggests a commonly used antibiotic for urinary tract infections (UTIs) may be tied to increased risk of congenital malformations when taken during the first trimester of pregnancy.
    • “The study, published today in JAMA Network Open, found that exposure to trimethoprim-sulfamethoxazole (TMP-SMX) during the first trimester was associated with increased risk of any malformation, severe cardiac and other cardiac malformations, and cleft lip and palate compared with beta-lactam antibiotics. No increased risk of congenital malformations was observed with nitrofurantoin, which is also commonly used to treat UTIs.
    • “The study partly substantiates the concerns of the American College of Obstetricians and Gynecologists (ACOG), which has suggested that TMP-SMX and nitrofurantoin be avoided during the first trimester when possible because of uncertainty about the risk of congenital malformations, though studies to date have produced mixed results. Despite the ACOG recommendation, the two antibiotics still account for more than half of first-trimester UTI prescriptions, according to the study authors.” 
  • STAT News adds,
    • “When several countries endorsed the notion of some high-risk people taking the antibiotic doxycycline after unprotected sex to lower their chances of contracting a sexually transmitted disease, as the U.S. did last year, there was a theoretical concern the shift could drive antibiotic resistance in some bacterial infections.
    • “That risk no longer appears to be theoretical.
    • “In a newly published letter in the New England Journal of Medicine, researchers reported a steep rise in resistance to tetracycline — the antibiotic class to which doxycycline belongs — in gonorrhea isolates collected from across the country since results of the studies investigating the use of so-called doxy PEP were made public. PEP is short for post-exposure prophylaxis. 
    • “An earlier report out of the University of Washington showed a similar trend in the Pacific Northwest, as well as a rise in tetracycline resistance in other bacteria carried by people who took doxy PEP, specifically Staphylococcus aureus and group A Streptococcus.”
  • and
    • About 1 in 3 young people who are 12 to 17 years old have prediabetes, new national data show, putting them at risk not just for type 2 diabetes but also for heart disease and stroke. Developing chronic diseases early in life also heightens their chances for worse outcomes from these conditions. 
    • Experts said the data reflect a concerning rise in obesity among teens but also noted that not all teens with prediabetes will progress to diabetes.
    • “The new report from the Centers for Disease Control and Prevention relied on the long-running National Health and Nutrition Examination Survey, which asked adolescents if they’d ever been diagnosed with diabetes and analyzed results of their fasting blood glucose or hemoglobin A1c tests. Its conclusion: In 2023, an estimated 8.4 million adolescents, or 32.7% of 12- to 17-year-olds, had prediabetes.”
  • Health Day lets us know,
    • “Three-quarters of stomach cancer cases could be prevented if doctors eradicate infection by a common type of bacteria, a new study says.
    • “The bacteria, Helicobacter pylori, is linked to 76% of future stomach cancer cases, researchers reported July 7 in the journal Nature Medicine.
    • “Most stomach cancers “are caused by chronic infection with H. pylori and can be prevented by treatment of the infection with a combination of antibiotics and proton pump inhibitors,” wrote the research team led by Jin Young Park, a scientist with the International Agency for Research on Cancer in Lyon, France.” * * *
    • “About 30,300 new cases of stomach cancer will occur in the U.S. this year, and about 10,780 people will die from this type of cancer, according to the American Cancer Society. Most cases occur in seniors.” * * *
    • “In the USA, there are currently no national guidelines or formal recommendations for gastric cancer prevention, although gastric cancer disproportionately affects Asian Americans, Hispanic Americans, African Americans and American Indian-Alaska Native individuals, and an increasing trend in young individuals (age <50 years) has been observed between 2016 and 2022, most notably in women,” researchers wrote.
    • “While H. pylori infections can be easily treated, researchers said it would be best if a vaccine for the bacteria is developed.
    • “Currently, only one H. pylori vaccine has passed phase 3 of a clinical trial,” researchers noted. “More investment in future vaccine trials focusing on pediatric populations should be made, clarifying the mechanisms of vaccine-associated immunoprotection.”
  • and
    • “Uterine cancer incidence and mortality rates are projected to increase significantly through 2050, according to a study published online July 1 in Cancer Epidemiology, Biomarkers & Prevention.
    • “Jason D. Wright, M.D., from the Columbia University College of Physicians and Surgeons in New York City, and colleagues developed a natural history model for uterine cancer to project trends through 2050.
    • “The researchers reported that uterine cancer is projected to increase in incidence and mortality through 2050. Black women will experience a disproportionate rise in incidence compared with White women between 2020 and 2050 (86.9 and 74.2 per 100,000, respectively), as well as a rise in mortality (27.9 and 11.2 per 100,000, respectively). For nonendometrioid tumors, White women will experience only a slight increase, while Black women will experience a substantial increase (10.8 and 36.3 per 100,000, respectively). Hypothetical screening and intervention methods were most effective when introduced at age 55 years with declines in cancer incidence that lasted up to 15 years in White women and up to 16 years in Black women.”
  • and
    • A healthy plant-based diet might protect people from inflammatory bowel diseases, a new study says.
    • People noshing healthy plant-based foods had a 14% lower risk of Crohn’s disease and an 8% lower risk of ulcerative colitis, researchers found.
    • On the other hand, an unhealthy diet containing more animal fats and vegetable oils was associated with a 15% increased risk of Crohn’s disease, results show.
    • “Our research indicates that a healthy plant-based diet may protect against inflammatory bowel disease, with its anti-inflammatory properties playing a key role,” senior researcher Dr. Zhe Shen of the Zhejiang University School of Medicine in China said in a news release.
  • The New York Times reports,
    • “Few practices in mental health are debated more than the long-term use of antidepressant medications, which are prescribed to roughly one in nine adults in the United States, according to data from the Centers for Disease Control and Prevention.
    • “A reassessment began in 2019, when two British researchers published a study that found that 56 percent of patients suffered from withdrawal symptoms when they stopped antidepressant medications and that 46 percent of those described their symptoms as severe.
    • “The findings made headlines in Britain and had a powerful ripple effect, forcing changes to psychiatric training and prescribing guidelines. And they fed a growing grass-roots movement calling to rein in the prescription of psychotropic drugs that has, in recent months, gained new influence in the United States with the rise of Robert F. Kennedy Jr. as health secretary.
    • “A new study, published on Wednesday in the journal JAMA Psychiatry, makes the case that these warnings were overblown. The authors of the new paper found that a week after quitting antidepressants, patients reported symptoms like dizziness, nausea and vertigo, but that they remained, on average, “below the threshold for clinically significant” withdrawal.”
  • Per MedPage Today,
    • “About half of teen vapers said they had tried to quit in the past year, and about a third wanted to try quitting in the next 6 months.
    • “The most common nicotine cessation tools used in these attempts were apps.
    • “No nicotine replacement therapy is approved for youth, but the American Academy of Pediatrics recommends considering off-label use for some adolescents.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck will buy Verona Pharma for roughly $10 billion, adding Ohtuvayre to its cardiopulmonary pipeline and portfolio.
    • “The acquisition helps Merck prepare for the loss of patent exclusivity for Keytruda in 2028.
    • “Verona shareholders will receive $107 per share, a 23% premium to Tuesday’s closing price.”
  • Healthcare Dive notes,
    • “Health insurers are steadily expanding their control over the U.S. primary care market — especially in areas with a lot of seniors eligible for Medicare Advantage plans, according to new research.
    • “In 2023, payer-operated practices accounted for 4.2% of the national Medicare primary care market by service volume, up from 0.8% in 2016, the study published in Health Affairs Scholar found. It’s the first concrete estimate of insurer ownership of physician practices nationwide and suggests that vertical consolidation is being driven by the potential for profits in nudging MA members to owned clinics, researchers said.
    • “The paper could also intensify the microscope on UnitedHealth as lawmakers and regulators scrutinize the healthcare behemoth’s outsized control over the industry. UnitedHealth-owned Optum was the largest operator of primary care clinics of all the insurers included in the analysis, holding more than 2.7% of market share nationally and more than 35% in several large counties.”
  • Per Beckers Health IT,
    • “A recent survey from the American Medical Association found that 66% of medical providers used AI in some capacity in the past year. That represented a dramatic 78% increase from the prior year.  
    • “Usage is only going up, but many providers remain skeptical about AI. Resistance to change is understandable—particularly when AI-focused headlines often seem better described as “clickbait” than substantive. However, practices that dismiss the idea of AI-enabled workflows are missing out on valuable opportunities to measurably boost efficiency, increase patient satisfaction, and reduce costs.  
    • “When applied strategically, AI can make a real impact in day-to-day practice operations and throughout the patient journey. So, how should a practice best determine where to focus efforts when it comes to AI enablement? 
    • “First and foremost, AI adoption should be thoughtful, not frenzied,” says Dr. Sanjeev Kumar, Ph.D., chief data and analytics officer at NextGen Healthcare and a globally recognized AI expert. “An AI-driven tool should always address real need and make life easier for the humans using it.” 
  • Fierce Healthcare adds,
    • “Nabla is integrating its AI medical scribe with Navina’s AI-enabled copilot to provide doctors with an AI layer that supports clinical workflows.
    • “The aim is to deliver real-time support through the full clinical encounter, according to the companies.
    • “The integration combines Navina’s clinician copilot with Nabla’s in-visit ambient documentation, reconciling historical patient records with live patient dialogue to help improve patient outcomes and financial performance.” 
  • Per Beckers Clinical Leadership,
    • “Columbus-based Ohio State University Wexner Medical Center and James Comprehensive Cancer Center researchers found about 1% to 2% of all inpatient hospitalizations resulted in patients discharging against medical advice — and these patients led to more than $800 million in annual associated healthcare costs.
    • “The study, published June 26 in Journal of the American College of Surgeons, used the data from 1,768,752 surgical patients between 2016 and 2020 in the Nationwide Readmissions Database. All patients underwent major surgeries in various medical specialties. Researchers evaluated trends in DAMA incidence, postoperative outcomes, risk factors for DAMA and 30-day healthcare expenditures.”

Weekend update

David Ermer–Congress, Medical / Rx research, Medicare, Mental health care–
  • From Washington, DC
  • The Wall Street Journal reports,
    • “The Senate geared up Sunday for an all-night session of debate and amendment votes on the GOP’s “big, beautiful bill” [HR 1], after Republicans narrowly advanced the measure in a 51-49 vote that set up more push-and-pull before final passage.
    • “The 940-page legislation is driving a wedge between the GOP’s two wings, just as the party is racing to pass the measure early this week. Centrists have raised concerns about cutting benefit programs and straining state budgets, while fiscal conservatives are pushing for even more cuts to rein in federal budget deficits. 
    • “Proponents maintain that the opportunity to pass President Trump’s core agenda items—and pressure from Trump on holdouts—would propel the package over the finish line in the Senate, where the GOP has a 53-47 majority. 
    • “It’s a big, beautiful bill if you believe in cutting people’s taxes, securing the border, having a strong military and controlling government spending,” Sen. Lindsey Graham (R., S.C.) said on the Senate floor Sunday. “The bottom line is, we’re about to make history,” he said.”
  • Here’s a link to the Journal’s explanation of the key provisions in the bill under Senate consideration. The Senate press gallery notes “The Senate will convene on Monday at 9:00 a.m. and begin the Vote-A-Rama on H.R. 1.” If the Senate passes the bill, then the Senate bill, which is based on the bill that the House passed in May, will go back to House for a vote. If the House approves the bill, then the bill will go to the President for signature into law.
  • Beckers Payer Issues calls attention to five Medicare Advantage bills pending in Congress.
  • The Wall Street Journal lets us know how “the Supreme Court dipped its toes into Trump 2.0” during its October 2024 term ended last Friday.

From the public health and medical research front,

  • Fortune Well reports,
    • For all of the advancement in treating stroke victims over the past couple of decades, some concerns have remained almost constant. In medicine, we like to say that “time is brain,” meaning that every moment a stroke goes untreated, the potential for long-term brain damage or death escalates. In fact, every minute that the brain goes without blood flow, the average patient loses around 1.9 million neurons and about a week of independent life, experts say.
    • “As the vast majority of strokes are ischemic, with a blood clot blocking the flow of oxygen to the brain, clearing that clot swiftly is critical. This is true whether the clot is small or large and regardless of its density—but reliably removing the densest clots via mechanical means has proved an elusive task.
    • “Though these concerns, time and density, are not necessarily linked, both matter—one reason, researchers suggest, that a newly developed technology from Stanford University holds the potential to reshape how stroke patients are treated.
    • “The device, called a milli-spinner, is a tiny, powerfully rotating hollow tube outfitted with fins and slits. In action, both lab and swine tests demonstrate the ability to dramatically compact and shrink the size of blood clots, making it easier to remove them quickly and effectively—often on the first try.
    • “This has the potential to be a game changer,” says Greg Albers, director of the Stanford University Stroke Center and a longtime expert in the field. “The results are likely to translate well to clinical trials.”
  • The New York Times tells us,
    • “Gary Sergott felt weary all the time. “I’d get tired, short of breath, a sort of malaise,” he said. He was cold even on warm days and looked pale with dark circles under his eyes.
    • “His malady was not mysterious. As a retired nurse-anesthetist, Mr. Sergott knew he had anemia, a deficiency of red blood cells. In his case, it was the consequence of a hereditary condition that caused almost daily nosebleeds and depleted his hemoglobin, the protein in red blood cells that delivers oxygen throughout the body.
    • “But in consulting doctors about his fatigue, he found that many didn’t know how to help. They advised Mr. Sergott, who lives in Westminster, Md., to take iron tablets, usually the first-line treatment for anemia.
    • “But like many older people, he found a daily regimen of four to six tablets hard to tolerate. Some patients taking iron complain of severe constipation or stomach cramps. Mr. Sergott felt “nauseated all the time.” And iron tablets don’t always work.
    • “After almost 15 years, he found a solution. Dr. Michael Auerbach, a hematologist and an oncologist who is the co-director of the Center for Cancer and Blood Disorders in Baltimore, suggested that Mr. Sergott receive iron intravenously instead of orally.
    • ‘Now Mr. Sergott, 78, gets an hourlong infusion when his hemoglobin levels and other markers show that he needs one, usually three times a year. “It’s like filling the gas tank,” he said. His symptoms recede, and “I feel great.”
    • “His story reflects, however, the frequent dismissal of a common condition, one that cannot only diminish older adults’ quality of life but lead to serious health consequences, including falls, fractures and hospital stays.”
  • The Washington Post informs us,
    • In her mid 70s, Argie, a widowed former teacher, began feeling poorly. She was tired. Her stomach hurt. Sometimes she got agitated. And she seemed forgetful.
    • Worried, her grown children urged the woman, who asked that only her first name be used for privacy reasons, to consult a memory specialist in Baltimore, not far from her home.
    • Argie’s cognitive powers, the doctor concluded, were reasonably good. But her medicine cabinet was a real hazard: She was taking 21 different prescription drugs, for diabetes, high blood pressure and her kidneys. After an assessment by a team that included a clinical pharmacy specialist well versed in drug interactions, she’s now down to eight.
    • “Every time I went in to a doctor, they gave me another pill,” Argie said. She’s now less confused. Less agitated. Less nauseated. She said cognitive challenges are manageable, and she’s more energetic and steadier on her feet.
    • “That overload of drugs, known as polypharmacy, can be dangerous at any age but it’s particularly hazardous for elderly people, who often have multiple health conditions and whose bodies may not handle meds the same way they did when they were younger, said Nicole Brandt, a leading expert on geriatric prescribing at the University of Maryland.”
  • Per Medscape,
    • “Posttraumatic headache (PTH) is frequently misdiagnosed and undertreated in nonspecialist settings, highlighting a critical gap in diagnostic accuracy, treatment access, and integrated care for this complex condition, new research showed. 
    • “Investigators found that patients with the condition are frequently misdiagnosed and undertreated in nonspecialist settings. Further, most are only correctly diagnosed with a migraine phenotype after evaluation by a headache specialist.
    • “A central message of our work is that the diagnosis of ‘headache’ is too often treated as a monolith — an endpoint rather than the beginning of a diagnostic journey,” study investigator Natalia Murinova, MD, clinical professor of neurology, and director of the headache clinic at the University of Washington (UW), Seattle, told Medscape Medical News.
    • “The results of the retrospective analysis were presented at the American Headache Society (AHS) Annual Meeting 2025.”

Weekend update

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Senate maintains a daily Executive Calendar. There are now eight nominees whose names were reported to the Senate floor before Scott Kupor. According to the unanimous consent resolution page in the front of the calendar, the Senate will consider tomorrow the nominations of the earliest reported nominee David Fotouhi (March 13) and two nominees reported in May after Mr. Kupor (April 9). The FEHBlog think that this is the pattern that the Senate leadership is following, which means that the Senate is likely to take up Mr. Kupor’s nomination later this month. 
  • Roll Call summarizes expected Congressional activities for this week here.
    • As Senate committees continue to release their proposals for the House-passed reconciliation package this week, the House plans to vote on President Donald Trump’s proposals to rescind foreign aid and other spending, including for public broadcasting.
    • “The rescissions request sent to Congress by the Trump Administration takes the federal government in a new direction where we actually cut waste, fraud, and abuse and hold agencies accountable to the American people,” House Majority Leader Steve Scalise, R-La., said in a statement.
  • The Supreme Court will be issuing another batch of opinions this coming Thursday.
  • Last Thursday, HR Dive tells us,
    • “A federal appeals court’s “background circumstances” requirement for majority-group plaintiffs who seek to prove job discrimination cuts against both Title VII of the 1964 Civil Rights Act and U.S. Supreme Court precedent, Justice Ketanji Brown Jackson wrote for a unanimous SCOTUS on Thursday.
    • “The court reversed the 6th U.S. Circuit Court of Appeals’ decision in Ames v. Ohio Department of Youth Services, which had dismissed a heterosexual woman’s claim that she was unlawfully passed over for a promotion in favor of a lesbian woman and subsequently demoted, after which a gay man was hired to fill her original role. The plaintiff alleged that those decisions constituted illegal discrimination on the basis of her sexual orientation, which the Supreme Court has said is a form of sex-based discrimination under Title VII.
    • “The 6th Circuit held that the plaintiff could not show background circumstances to support her suspicion that her employer discriminated against her on the basis of her status as a member of a majority group.
    • “Justice Jackson, however, wrote that such requirements flout the Supreme Court’s case law, which “makes clear that the standard for proving disparate treatment under Title VII does not vary based on whether or not the plaintiff is a member of a majority group.”
    • “The court vacated and remanded the case to the 6th Circuit for further proceedings.”
  • Federal News Network interviews Tammy Flanagan about “what retiring feds need to know about their benefits in transition.”
    • “Timing is everything when thinking about when to drop your retirement paperwork. Understanding what happens to your leave balances, health insurance, and survivor benefits can inform that decision. Hear with more on those key considerations is the Founder and Principal Retirement specialist at Retire Federal, Tammy Flanagan.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “A new gene-tracking study in Nature shows that mpox spread among people in Nigeria for 8 years before it sparked a global outbreak in 2022.
    • “Using genomic tracing, researchers from Nigeria, the United States, Cameroon, Ethiopia, and Belgium estimate that the ancestor of the clade 2 mpox virus (mpxv) that ignited an international outbreak beginning in May 2022 first emerged in southern Nigeria in August 2014 and spread to 11 Nigerian states before human infections were detected in 2017. 
    • “In light of the findings, the authors write, “We need improved surveillance in the wildlife population in the forest systems to better understand the transmission and maintenance of MPXV in animal hosts,” as well as better human surveillance.
    • “We could have very easily prevented the 2022 multi-country outbreak if countries in Africa were given better access to therapeutics, vaccines, and surveillance technologies,” says first author Edyth Parker, PhD, MPhil, a researcher with the Institute of Genomics and Global Health and with the International Biosecurity and Biosafety Initiative for Science, in a Scripps Research news release. “In a vulnerably connected world, we cannot neglect epidemics until they get exported to the Global North.”
  • Medscape offers these reports from the recent American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • Changing the prescribing protocol for low-dose aspirin (LDA) for preeclampsia prevention from risk-based to universal significantly increased aspirin use in pregnant patients, based on new data presented at the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • The use of LDA to reduce the risk for preeclampsia has been well established as an inexpensive and simple intervention, but it has remained underutilized nationwide, said lead author Meryl Y. Grimaldi, MD, of SBH Health System, New York City, in an interview.
    • “Many of the patients we care for at SBH Health are at high risk for preeclampsia, but we wanted to ensure that our eligible patients received the benefits of this intervention,” said Grimaldi, who presented the study at the meeting.
  • and
    • “Clinicians need to discuss and offer all patients a variety of pain management options for in-office gynecologic procedures ranging from intrauterine device (IUD) insertion to biopsies, according to new guidance published by the American College of Obstetricians and Gynecologists (ACOG). The guidelines, published on May 15, are the first formal ones from ACOG to not only acknowledge the range of pain experiences that can be associated with different procedures but also to explicitly lay out recommendations for the conversations providers should have with their patients about what pain management options are available.
    • “This guidance speaks to more than just Ob/Gyns,” Co-Author Genevieve Hofmann, DNP, women’s health nurse practitioner and assistant professor of Ob/Gyn at the University of Colorado School of Medicine in Aurora, Colorado, said during a discussion with the press on May 17 at American College of Obstetricians and Gynecologists (ACOG) Annual Meeting in Minneapolis. “It speaks to any physician who’s providing these types of services and certainly to advanced practice registered nurses who work in women’s health and provide these services.”
  • Medscape adds,
    • Regeneron said on Monday [June 2, 2025,] its experimental drug helped patients preserve up to 51% of lean mass and lose more fat when used in combination with Novo Nordisk’s popular obesity drug Wegovy in a mid-stage trial. 
    • In the 599-patient study, those on Wegovy alone lost about 7.9 pounds of muscle, while those on a combination of Regeneron’s trevogrumab and Wegovy lost up to 4.2 pounds. 
    • The combination helped patients shed up to 11.3% of their body weight compared with 10.4% for those on only Wegovy. 
    • The results mark an early win for Regeneron in the race against nearly a dozen companies to develop obesity treatments that preserve muscle, as they vie for a share of the potential $150 billion weight-loss drug market. 

From the U.S. healthcare business front,

  • Medical Economics “spoke with Mark McClellan, M.D., Ph.D., director, Duke-Margolis Institute for Health Policy, and a former administrator at CMS, about why value-based care hasn’t been adopted more quickly.” and let us know that “New Marit Health data from May, 2025, reveal that physicians feel most satisfied where compensation aligns with cost of living, practice expectations and quality of life. These 10 states show that perceived fairness matters just as much as raw earnings.”
  • The Wall Street Journal reports,
    • Unexpected healthcare costs can arise in retirement, such as uncovered drugs, isolation and concierge care.
    • Medicare Part D may not cover all drugs, potentially leading to high out-of-pocket expenses for uncovered medications.
    • Retirees may face unexpected travel costs for medical care based on retirement location or feel compelled to pay for concierge medical care.
  • All PSHB plans and Most FEHB plans offer Medicare Part D plans which are integrated with the regular plan formulary, thereby reducing one of the Journal’s identified risks.
  • Per BioPharma Dive,
    • “Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new CEO two months ago and inherited a company whose cancer medicines have, over the past half-decade, won it three of the pharmaceutical industry’s largest licensing deals.
    • “One of those medicines, the antibody-drug conjugate Enhertu, again took the spotlight at the American Society of Clinical Oncology’s annual meeting here, showing potential to become part of standard therapy for the frontline treatment of advanced breast cancer. It did the same in 2022 and 2024.
    • “Okuzawa can point to Enhertu and four other antibody-drug conjugates Daiichi Sankyo’s developing with AstraZeneca and Merck & Co. as proof of the strength of its research laboratories. By 2030, the company plansto have these five “ADCs” approved across more than 30 tumor types, which would allow it to treat nearly 400,000 cancer patients each year.
    • “We’d like to become one of the most important players in oncology,” said Okuzawa, noting aspirations to crack the top 10 companies by cancer drug sales. “Our senior leaders are now talking about not only top 10, but maybe top 5. We’re very much confident in our ADCs.”
  • Per Fierce Healthcare,
    • Neuroscience technology company Brooklyn Health is using artificial intelligence to target a fundamental problem in neurology and psychiatry: the flawed approach to mental health outcomes measurement.
    • The startup aims to modernize mental health measurement and scoring in central nervous system (CNS) drug development, an area of CNS research that faces limitations in objectivity and standardization. 
    • “Clinical interviews, the standard for symptom assessment, are fundamentally unreliable and imprecise,” said Anzar Abbas, Ph.D., a neuroscientist and founder of Brooklyn Health, in an interview.
    • “Brooklyn’s platform uses AI and digital phenotyping methods it developed to evaluate the quality and scoring of clinical interviews in real time.” * * *
    • “Brooklyn’s current focus in on drug development and central nervous system clinical trials to improve outcome measurement, essentially, how well a drug is working. But the company has ambitions beyond clinical trials to support outcome measurement across all forms of behavioral health delivery, including in-clinic psychiatric care and virtual mental health platforms.” 
  • The Washington Post reports on a smartphone app Death Clock AI that predicts how many years a user has left before beginning to push daisies as they day.

Friday report

David Ermer–AHRQ, CDC, Congress, COVID-19, Employee Wellness Programs, FDA, Medical / Rx research, Mental health care, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News reports,
    • “Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Andy Kim, D-N.J., June 5 reintroduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with continuing its efforts addressing sepsis care. The agency’s work would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, and developing and implementing a sepsis outcome measure.
    • “The bill would also require a report on a sepsis outcome measure and a congressional briefing on the CDC’s sepsis activities. Additionally, the legislation includes a voluntary recognition program for hospitals that maintain effective sepsis programs or improve their programs over time.”
  • and
    • “The House June 4 passed the AHA-supported SUPPORT Act (H.R. 2483) by a 366-57 vote. The legislation reauthorizes key prevention, treatment and recovery programs for patients with substance use disorder, including programs to support the behavioral health workforce.”
  • Federal News Network tells us,
    • “More federal employees filed retirement papers with the Office of Personnel Management in May than in the last three months. OPM said it received more than 15,000 claims last month, driving the backlog up over 21,000. The processing time for these retirement claims remain consistent at 49 days on average in May and 52 days on average for the entire 2025. The increase in applications comes as OPM is requiring agencies to send retirement paperwork only in digital formats by July 15. OPM launched two new tools this week to improve the retirement services process. One is a new platform for agency HR and payroll providers and another to modernize the Electronic Official Personnel Folder (eOPF) platform.”
  • CMS shared “Federal Independent Dispute Resolution (IDR) Technical Assistance for Certified IDR Entities and Disputing Parties –June 2025 — Topic: Errors Identified After Dispute Closure.”
  • BenefitFocus discusses “Health Care Transparency 2.0 – What Might We See in Forthcoming Transparency Regulations.”

From the Food and Drug Administration front,

  • Per BioPharma Dive, “FDA meeting gives window into gene therapy field’s angst. Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.”
  • Per MedTech Dive,
    • “Medtronic is recalling certain tracheostomy tubes because of the risk that the devices could dislodge, causing an emergency where the patient cannot breathe or their airway is blocked, according to a Thursday Class I recall notice from the Food and Drug Administration. 
    • “The company sent a notice to customers on Feb. 26 asking them to quarantine and return all unused tubes from the affected lot. The recall applies to the Shiley adult flexible tracheostomy tube with taperguard cuff reusable inner cannula.
    • “Medtronic began the recall after receiving reports from customers that the flange used to secure the device may become disconnected. Patient harm was reported in some cases, but no deaths have been reported to date, a company spokesperson wrote in an email Thursday.”
  • BioPharma Dive relates,
    • “Vera Therapeutics lost nearly a third of its market value Friday after Otsuka Pharmaceutical presented late-stage study data on a rival drug it’s developing for the kidney disease IgA nephropathy. At a medical meeting, Otsuka said its therapy, sibeprenlimab, led to a 51% reduction in proteinuria, a key marker of kidney health, after nine months of treatment. Though cross-trial comparisons can be misleading, Vera’s therapy led to a 42% reduction in proteinuria compared to placebo at a similar timepoint in its own Phase 3 study, causing investors to sell off company shares. Still, some analysts defended Vera. Jefferies’ Farzin Haque cautioned not to “overinterpret the data” and argued the two datasets “are not clinically or statistically different for commercial uptake.” The Food and Drug Administration could approve Otsuka’s drug by Nov. 28. On Monday, Vera said it intends to file an accelerated approval application in the fourth quarter.”

From the judicial front,

  • Beckers Hospital Review informs us,
    • “The CEO of a healthcare software company was convicted by a federal jury for his role in operating a platform that generated fraudulent physicians’ orders to defraud Medicare and other payers out of more than $1 billion.
    • “Gary Cox, 79, of Maricopa County, Ariz., was the CEO of Power Mobility Doctor Rx (DMERx), an internet-based platform that generated fraudulent orders for unnecessary orthotic braces, pain creams and other items, according to a June 3 Justice Department news release.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Seasonal influenza, COVID-19, and RSV activity is low.
    • COVID-19
      • COVID-19 wastewater activity is low and emergency department visits and laboratory percent positivity are at very low levels.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The AHA News lets us know,
    • “There have been 1,168 confirmed cases of measles across 33 states as of June 6 this year, according to the latest data from the Centers for Disease Control and Prevention. This year’s figure is more than four times higher than the 2024 total of 285 cases. There have been 17 outbreaks this year, and 89% of confirmed cases (1,040 of 1,168) are outbreak-associated. The vaccination status of 95% of all cases is classified as “unvaccinated or unknown.” 
  • Of note, Health Day warns us,
    • “An afternoon snooze might seem appealing to middle-aged folks and seniors, but these naps could carry a high cost.
    • “People with certain types of napping patterns have a greater risk of an early death, researchers are slated to report at an upcoming meeting of the American Academy of Sleep Medicine (AASM).
    • “People who slept longer during the day, had irregular daytime sleep patterns, or slept more around midday and early afternoon were at greater risk, even after accounting for health and lifestyle factors,” lead researcher Chenlu Gao, a postdoctoral research fellow at Massachusetts General Hospital in Boston, said in a news release.
    • “The findings call into question the whole concept of the “power nap.”
  • HHS’s AHRQ posted a report about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • Per HR Dive,
    • “Work can either fuel employee well-being or become a source of strain for employees already stressed out by economic volatility and political tension, according to a May 12 survey of employee mental health by Inmar Intelligence.
    • “Of the 1,000 U.S. full- and part-time employees who responded to the May 12 survey, 34% said their job positively impacts their mental health, while 33% reported a negative impact, Inmar found.
    • “This near-even split reinforces the importance of thoughtful leadership and inclusive workplace design to support the full spectrum of employee needs,” the business technology firm stated in a May 29 post.”
  • Cardiovascular Business reports,
    • “Heart surgeons with the WVU Heart and Vascular Institute have made a bit of history, performing the world’s first robotic explant of a transcatheter aortic valve replacement (TAVR) device and subsequent aortic valve replacement.
    • “The group already has plenty of experience breaking new ground in the field of robotic-assisted surgery. They developed a robotic aortic valve replacement (RAVR) technique that is now being used all over the world and performed the world’s first robotic aortic valve replacement and coronary artery bypass (RAVCAB) procedure in 2024.
    • “This latest breakthrough started when Thelma Hyer, a 67-year-old female patient, presented with a failing TAVR valve in addition a leaky mitral valve. She had received her TAVR valve just four years prior, but premature structural valve degeneration had already made a full replacement necessary.
    • “Vinay Badhwar, MD, executive chair of the WVU Heart and Vascular Institute, initially recommended open-heart surgery to remove the failing TAVR valve and then replace her aortic and mitral valves. However, Hyer and her family had hesitations due to her history of scoliosis and arthritis. Badhwar then proposed using robotics as an alternative. 
    • “The technology had never been used in this exact way before, but Badhwar was confident in the abilities of both his team and the robotic surgery platform. The group developed a plan, talked it over with the patient, and went forward with the robotic procedure in late May. 
    • “The operation—including the TAVR explant and the replacement of both heart valves—appears to have been a success. Hyer was discharged after less than a full week of observation.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Omada Health shares jumped after the company made its public-market debut, propelled by Americans’ renewed focus on how weight affects physical health.
    • “Shares of the virtual healthcare platform climbed 35% to $25 on Friday, at one point hitting a high of $28, above the initial offering price of $19. The price gives it a market valuation of around $1.4 billion.
    • “The gains are a sign investors are willing to invest in newly public companies after a volatile stock market pushed some companies like payments platform Klarna to delay its IPO filing. Stablecoin issuer Circle opened on Thursday at $69, more than double its offering price, and was recently trading at $119.15. Hinge Health HNGE 0.83%increase; green up pointing triangle, another digital health company, opened in May at $39 after offering a $32 price.
    • “Omada is trading publicly after 14 years of providing support to patients with weight-related chronic illnesses. Leadership sees the current moment as the perfect time for an IPO, as GLP-1 drugs such as Ozempic, Wegovy and Mounjaro have sparked renewed focus on health problems that can stem from obesity, President Wei-Li Shao said.
    • “We’re entering this unique moment in time where there’s a convergence between what we’ve been working on for over a decade, and then also what society is increasingly caring about,” Shao said.”
  • Becker Hospital Review discusses ten key transactions that created Ascension 2.0.
    • “Over the last 16 months, St. Louis-based Ascension has sold or consolidated about 35 hospitals across the country as it revamps its hospital portfolio, operating model and overall financial performance.
    • “Despite reporting a $466 million operating loss (a -2.4% margin) for the nine months ending March 31, 2025, the Catholic nonprofit system has made notable strides in improving its liquidity position. That progress is largely attributed to the successful collection of accounts receivable that had temporarily spiked due to two major cybersecurity incidents — the May 2024 ransomware attack and the February 2024 Change Healthcare cyberattack.
    • “Since the fourth quarter of fiscal 2024 — the three months ending June 30, 2024 — Ascension has improved recurring operating performance by $1.4 billion, while increasing patient volumes and same-facility revenue.”
  • Beckers Health IT tells us,
    • “California-based Stanford Health Care is piloting an internally developed, AI-backed software designed to revolutionize clinician interaction with the EHR.
    • “Nigam Shah, MBBS, PhD, chief data science officer at Stanford Health Care, is leading the development team for ChatEHR, which allows clinicians to ask questions, request summaries and pull specific information from a patient’s medical record. ChatEHR is built directly into Stanford’s EHR to maximize clinical workflow.
    • “The pilot is available to a small cohort of 33 physicians, nurses and physician assistants. The technology is secure and designed for information gathering; not medical advice.
    • “ChatEHR, which has been in development since 2023, facilitates a more streamlined and efficient way for clinicians to interact with patient records.
    • “This is a unique instance of integrating [large language model] capabilities directly into clinicians’ practice and workflow,” said Michael Pfeffer, MD, chief information and digital officer at Stanford Health Care and School of Medicine, in a news release. “We’re thrilled to bring this to the workforce at Stanford Health Care.”
  • Drug Store News informs us,
    • “Walmart has become the first retailer to scale its drone delivery to five states with its recently announced service expansion in Atlanta, Charlotte, Houston, Orlando and Tampa. The new service will launch at 100 stores throughout Arkansas, Florida, Georgia, North Carolina and Texas, in addition to current operations in Northwest Arkansas and the Dallas-Fort Worth area.
    • “As we look ahead, drone delivery will remain a key part of our commitment to redefining retail,” said Greg Cathey, SVP, Walmart U.S. transformation and innovation. “We’re pushing the boundaries of convenience to better serve our customers, making shopping faster and easier than ever before.”
    • “Continued Cathey: “This expansion of our drone delivery service marks a significant milestone in that journey. As the first retailer to scale drone delivery, Walmart is once again demonstrating its commitment to leveraging technology to enhance our delivery offerings with a focus on speed.” 

Thursday Report

David Ermer–Congress, COVID-19 testing, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Modern Healthcare reports,
    • “Senate Republicans are considering cuts to Medicare spending to help pay for Donald Trump’s signature legislative package.
    • “The GOP lawmakers are proceeding cautiously as they expand their search for savings to a popular health insurance program nearly all Americans rely upon in retirement, presenting the move as an effort to root out waste, fraud and abuse. That includes cutting payments to health insurance companies that run private Medicare plans.”
  • The Wall Street Journal adds,
    • “Humana, the second-biggest Medicare insurer, has told congressional staffers that it will support moves that would curtail billing practices worth billions in extra payments to the industry, according to staffers and a document viewed by The Wall Street Journal.
    • “The stance by a leader in the Medicare Advantage business—in which insurers offer privately run Medicare plans—represents an important development in a growing debate over how the companies are paid in the $460 billion program.
    • “Insurers get paid more for covering sicker patients in Medicare Advantage, giving companies an incentive to record more diagnoses. Humana has told congressional staffers that it is willing to back new limits on lucrative payments insurers can gain from diagnoses recorded by nurse practitioners who visit millions of enrollees in their homes, according to a one-page policy overview shared with congressional staffers.
    • “After the Journal published this article Thursday morning, the biggest Medicare insurer, UnitedHealth Group, posted a statement saying that it too would support a new limit on the use of diagnoses from home visits.”
  • Healio points out,
    • HHS has ended a government-funded program that distributed free COVID-19 tests to community organizations, a department spokesperson confirmed to Healio.
    • “With COVID-19 behaving more like the seasonal flu — rising and falling through the year — and tests widely available at retail stores nationwide, continued federal distribution is a significant waste of taxpayers’ dollars,” the spokesperson said. “The COVID-19 pandemic is over.” * * *
    • “The program differed from the mail-based program that was started and stopped several times throughout the pandemic and provided U.S. residents the opportunity to get free COVID-19 tests delivered directly to their homes.”
    • “HHS is in the process of purchasing a supply of tests that can distinguish between COVID-19 and influenza to have on hand for emergencies.”
  • Tammy Flanagan, writing in Govexec, discusses “Should you stay, or should you go? 10 tips for navigating your federal retirement decision. What to consider—financially and emotionally—before leaving government service.”

From the public health and medical research front,

  • Chief Healthcare Executive tells us,
    • Two years ago, the American Diabetes Association and The Leapfrog Group announced that they were joining forces to recognize hospitals for providing excellent care to patients with diabetes.
    • Now, the groups are announcing honors for a second batch of recipients, and they’re recognizing more than twice as many hospitals.
    • The American Diabetes Association and the Leapfrog Group have announced 36 hospitals as 2025 Recognized Leaders in Caring for People Living with Diabetes. A year ago, the groups recognized 17 hospitals [which are listed in the article].
    • The organizations say they want to give public recognition to hospitals, but they are also highlighting the importance of providing proper care for patients with diabetes.
    • Nearly one-third of patients admitted to hospitals (30%) are diagnosed with diabetes. Some of those are patients that are being treated in the hospital for another illness or injury.
  • The New York Times reports,
    • “The technology that powered Covid vaccines may also lead scientists to a cure for H.I.V. Using mRNA, Australian researchers said they were able to trick the virus to come out of hiding, a crucial step in ridding the body of it entirely.
    • “The research, published last week in Nature Communications, is still preliminary, and so far, has been shown to be successful only in a lab. But it suggests that mRNA has potential far beyond its use in vaccines as a means to deliver therapies against stubborn adversaries.
    • “Short for messenger RNA, mRNA is a set of instructions for a gene. In the case of Covid vaccines, the instructions were for a piece of the coronavirus. In the new study, they are for molecules key to targeting H.I.V.
    • “Dr. Sharon Lewin, director of the Cumming Global Center for Pandemic Therapeutics in Melbourne, who led the study, called mRNA a “miraculous” tool “to deliver things that you want into places that were not possible before.”
  • STAT News adds,
    • “People with diabetes who were taking GLP-1 drugs had a low but elevated risk of an age-related eye disease that can sometimes lead to blindness, a new observational study concludes, adding to a short list of concerns about eye health in people taking the powerful medications.
    • “The research, published Thursday in JAMA Ophthalmology, found that after one year, more than twice as many people on GLP-1 drugs developed neovascular age-related macular degeneration compared to similar people who were not taking the drugs. The risk was 0.2% in people taking GLP-1s and 0.1% in those who didn’t. Participants, drawn from health records of nearly 140,000 patients in Canada, were matched for socioeconomic status and a long list of conditions in addition to diabetes.” * * *
    • “Seeing such a clear signal in our study was striking,” co-author Reut Shor of the University of Toronto told STAT. “The absolute risk remains low, but the advanced form of AMD is a condition with serious implications for vision and quality of life. So a doubling of risk is clinically meaningful, particularly for vulnerable populations like older adults who may already be at elevated baseline risk.”
  • Per Health Day,
    • “A quality improvement strategy can improve electronic health record-based screening for depression and anxiety in people with epilepsy, according to a study published online April 16 in the Journal of Clinical and Translational Science.
    • “Heidi M. Munger Clary, M.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues developed an implementation strategy for anxiety and depression screening among people treated at an epilepsy center. Implementation outcomes were evaluated five months postimplementation compared to two three-month preimplementation time frames.”
  • and
    • Dietary patterns seem to be associated with depressive symptoms, according to a study published online June 3 in BMJ Nutrition, Prevention & Health.
    • Gabriella Menniti, M.D., from Unity Health Toronto, and colleagues conducted a cross-sectional study using National Health and Nutrition Examination Survey 2007 to 2018 data to examine the association between restrictive dietary patterns and depressive symptoms stratified by sex and body mass index.
  • Per MedPage Today,
    • High blood pressure (BP) awareness increasingly slipped under the radar since the COVID-19 pandemic, according to nationally representative health data.
    • Results from National Health and Nutrition Examination Survey (NHANES) cycles, spanning the years 2013 to 2023, showed no improvement in the proportion of adults having hypertension, diabetes, and high cholesterol who self-reported being unaware and never diagnosed. In fact, hypertension awareness stood out for trending significantly in the wrong direction:
      • Adults with hypertension not realizing it: 14.6% in 2013-2014 to 17.8% in 2021-2023
      • Adults with diabetes not realizing it: 27.5% to 28.9%
      • Adults with high total cholesterol not realizing it: 11.5% to 11.9%
    • “Given declining cardiometabolic health in young adults, it is concerning that approximately one in three with hypertension, two in five with diabetes, and one in four with a high cholesterol level are unaware of having these conditions. Policy efforts to address these gaps in awareness are needed to prevent future cardiovascular events,” wrote Rishi Wadhera, MD, MPP, MPhil, of Beth Israel Deaconess Medical Center and Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Cardiology“

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us,
    • “Nonprofit hospitals are seeing margins improve as patient demand for care soars, according to Kaufman Hall’s “National Hospital Flash Report” released June 5.
    • “Kaufman Hall, a Vizient company, analyzed data from 1,300 hospitals collected by Strata Decision Technology for its monthly report.
    • “Hospital performance from January to April outpaced the first four months of 2024, largely driven by patient volume and hospital efficiency,” said Erik Swanson, managing director and group leader, data and analytics, at Kaufman Hall. “Operating room minutes, ED visits and inpatient revenue are trending upward, demonstrating a strong demand for services. A decline in average length of stay indicates that hospitals are triaging, treating, and discharging patients effectively and appropriately.”
  • Modern Healthcare reports,
    • “Nineteen critical access hospitals in Nebraska have formed a clinically integrated network, the third coalition of its kind created over the past three months.
    • “The Nebraska High Value Network aims to give rural hospitals the scale to lower costs, invest in new technology, improve treatment and expand value-based contracts while remaining independent. The network, announced Thursday, follows similar alliances in Montana, Ohio, Minnesota and North Dakota.” * * *
    • “Cibolo Health, the rural health advisory firm that helped launch these hospital collaborations, will manage daily operations of the Nebraska High Value Network. The network will include clinical and business integration committees led by member hospital executives who will oversee quality and administrative initiatives.”
  • Beckers Clinical Leadership lets us know,
    • “The District of Columbia has the most physicians per 100,000 population, while Idaho has the fewest specialist physicians and Nevada has the fewest primary care physicians per 100,000, KFF data found.
    • “KFF used data from Redi-Data to find the number of MD and DO active state-licensed physicians as of April 2025. Becker’s used Census data from 2025 to find the population of each state.
    • “There are 535,542 primary care physicians and 570,655 specialist physicians in the U.S. this year.
    • “[The article includes a chart with] the number of primary care and specialist physicians per 100,000 people in each state and the District of Columbia.”
  • Per MedTech Dive,
    • “Johnson & Johnson CFO Joseph Wolk, at the Bernstein investor conference last week, tempered the company’s expectation that it would suffer a $400 million tariff impact this year.
    • “Wolk gave the update after the U.S. and China reached a temporary agreement to pause escalating tariff rates between the two countries for 90 days.
    • “Weeks before the pause, J&J had predicted on an April’s earnings call that it would incur tariff-related costs of about $400 million this year, primarily affecting its medtech business.
    • “But Wolk, at the Bernstein conference, suggested the forecasted tariff hit could change in the future.
    • “Just based on the retaliatory China tariffs that we had in our $400 million assessment, that probably cuts the $400 million down to $200 million,” Wolk said, responding to a question about the shifting tariffs landscape. That does not include any impact that could result from the Trump administration’s Section 232 investigations, he said. The Trump administration has launched special investigations into the pharmaceutical and semiconductor industries that could lead to tariffs.
    • “In addition, Wolk noted, tariffs between the U.S. and Europe remain in flux.” 

Friday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NCQA, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash
  • The University of Minnesota’s CIDRAP tells us,
    • “The Centers for Disease Control and Prevention (CDC) yesterday updated its childhood immunization schedule with a revised recommendation on COVID-19 vaccines for healthy children.
    • “The changes partly reflect a new position on COVID vaccine recommendations for healthy children announced earlier in the week by Department of Health and Human Services Secretary Robert F. Kennedy Jr., though they do not go as far as Kennedy had suggested.
    • “The CDC childhood immunization schedule now says that healthy children ages 6 months to 17 years, when the parent expresses a desire for their child to vaccinated, “may receive COVID-19 vaccination, informed by the clinical judgement of a healthcare provider and personal preference and circumstances.” Previously, the agency had recommended COVID-19 vaccines for healthy children ages 6 months and older, based on the recommendation of the CDC’s Advisory Committee on Immunization Practices.” * * *
    • “[A]ccording to the CDC, shared clinical decision-making recommendations on the immunization schedule are required to be covered by private insurers [with no cost sharing when provided in-network] under the Affordable Care Act.
    • “The CDC is still recommending COVID vaccination for children ages 6 months to 17 years who are moderately or severely immunocompromised.”
  • Govexec informs us,
    • “The White House on Friday told the government’s top watchdog it will only cooperate when doing so does not impede its ability to carry out President Trump’s agenda, reigniting a feud that traces back to the president’s first term in office. 
    • “The letter, from Office of Management and Budget General Counsel Mark Paoletta to the Government Accountability Office, follows the watchdog last week finding the Trump administration violated federal spending laws by withholding money appropriated by Congress. Paoletta denied that the administration has flouted the Impoundment Control Act, the law that prohibits the executive branch from withholding congressionally appropriated funds for policy reasons. 
    • “The OMB official criticized GAO for asking too many questions of the White House, including the dozens of probes the watchdog has opened into potential illegal impoundments. Paoletta noted that GAO has around 50 “open engagements” with the budget office. 
    • “Not only does GAO exceed its statutory authority when it unhelpfully injects itself into an agency’s implementation of a program, GAO also hampers the Executive Branch’s ability to carry out its statutory mandates,” Paoletta said in the letter, which was first reported by The Washington Post. He added the legislative branch agency often attempts to substitute its “policy views for those of the president.” 
  • The American Medical Association News lets us know,
    • “The Government Accountability Office May 29 released a report recommending the Centers for Medicare & Medicaid Services target behavioral health services when auditing Medicare Advantage plans’ use of prior authorization. CMS said it currently does not target behavioral health services because they make up a small percentage of MA services, the report said.     
    • “The report describes selected MA organizations’ prior authorization requirements and use of internal coverage criteria for prior authorization decisions on behavioral health services. It also examines CMS’ oversight of the use of internal coverage criteria, among other issues. GAO said that CMS “would take the recommendation under advisement in the future.” 

In Food and Drug Administration news,

  • Per Healio,
    • “The FDA approved Tryptyr to treat the signs and symptoms of dry eye disease, according to a press release from Alcon.” * * *
    • “Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” Marjan Farid, MD, professor of ophthalmology at the University of California, Irvine, said in the release. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.” * * *
    • “Alcon expects a third quarter launch for Tryptyr in the U.S.”
  • Per HCPLive,
    • “The US Food and Drug Administration (FDA) has approved hydrocortisone (KHINDIVI) oral solution as a replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency.1
    • “Announced by Eton Pharmaceuticals on May 28, 2025, this approval marked the first FDA-approved oral solution formulation of hydrocortisone, designed to address administration and dosing accuracy in patients who may have difficulty swallowing pills or special administration needs.” * * *
    • “Adrenal insufficiency is a rare, serious condition characterized by decreased production of aldosterone and cortisol due to reduced adrenal gland function. It can present acutely in an adrenal crisis or chronically, and if not recognized, can lead to very high morbidity and mortality.2 In the release, Eton Pharmaceuticals estimated that more than 5,000 adrenal insufficiency patients are present in the US between the ages of 5 and 17.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Seasonal influenza, COVID-19, and RSV activity is low.
    • COVID-19
      • COVID-19 wastewater activity, emergency department visits, and laboratory percent positivity are at very low levels.
      • Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The University of Minnesota’s CIDRAP adds,
    • “The US Centers for Disease Control and Prevention (CDC) in its weekly update today reported 42 measles cases, some tied to a large outbreak centered in West Texas and others linked to instances of community transmission or travel to other states or countries, lifting the nation’s total to 1,088 infections.
    • “Two more states reported their first cases this week, Iowa and Nebraska, putting the number of affected jurisdictions at 33. The number of outbreaks remained at 14, and 90% of cases are linked to outbreaks.” * * *
    • “The Texas Department of State Health Services (TDSHS) today reported 9 more cases in the West Texas outbreak, putting the total since January at 738. Though 35 counties have reported cases linked to the outbreak, only 7 still have ongoing transmission. 
    • “Like other states, Texas also continues to record measles cases from various sources that apparently aren’t linked to the larger outbreak, and today officials reported 8 more such infections, lifting that total to 32. 
    • “A few other states have reported cases linked to West Texas activity, but no new illnesses were reported in New Mexico or Oklahoma. On May 28, Kansas reported a total of 64 cases from 11 counties, 59 of them linked to an outbreak in the southwestern part of the state.’
  • CBS News reports,
    • “Hormel Foods Corporation is recalling over 256,000 pounds of canned beef stew nationwide due to potential contamination with wood fragments, according to federal health officials.
    • “In a recall notice posted Wednesday [May 28], the U.S. Department of Agriculture’s Food Safety and Inspection Service said the 20-oz. metal cans containing “Dinty Moore Beef Stew” were shipped to retail locations nationwide.
    • “The recalled products have a “FEB 2028” best by date, lot code “T02045” and establishment number “EST 199G” printed on the can. 
    • “The problem was discovered after the establishment notified FSIS that they had received three consumer complaints reporting pieces of wood in the beef stew product,” the notice read. 
    • “So far, there have been no confirmed reports of injury.”
  • The American Medical Association lets us know “what doctors wish patients knew about improving eye health.”
  • Health Day points out,
    • “Among U.S. youth, overdose deaths attributable to synthetic opioids alone are increasingly predominant, according to a study published online May 20 in Pediatrics.
    • “Megan Miller, M.P.H., from the New York University Grossman School of Medicine in New York City, and colleagues examined trends in overdose deaths involving combinations of synthetic opioids with benzodiazepine, cocaine, heroin, prescription opioids, and other stimulants. Findings were based on U.S. youth aged 15 to 24 years from 2018 to 2022 using the National Vital Statistics System multiple cause of death datasets.
    • “The researchers found that between 2018 and 2022, overdose death counts increased from 4,652 to 6,723 (10.85 to 15.16 per 100,000), with a slight decrease between 2021 and 2022. Deaths involving synthetic opioids only showed the largest increases (1.8 to 4.8 deaths per 100,000). Regardless of race, ethnicity, or sex, fatal synthetic opioid-only overdose rates were higher than polydrug overdose rates involving synthetic opioids since 2020. In 2022, rates of synthetic-only overdose deaths were 2.49- and 2.15-times higher among male versus female youth and among those aged 20 to 24 versus 15 to 19 years, respectively.”
  • and
    • “Heart disease, strokes and diabetes contribute to many dementia cases in the United States, but the risk is not equal everywhere, a new study says.
    • “Overall, more than a third (37%) of U.S. dementia cases are linked to eight conditions: diabetes, heart failure, atrial fibrillation, coronary artery disease, heart attack, stroke, high blood pressure and high cholesterol, researchers found.
    • “The South has the strongest link between these diseases and dementia, researchers reported recently in the journal Alzheimer’s & Dementia.
    • “A substantial number of dementia cases could be eliminated by mitigating modifiable cardiometabolic risk factors, especially in U.S. counties with a high risk of dementia attributed to these risk factors,” senior researcher Dr. Brad Racette said in a news release. He’s chair of neurology at Barrow Neurological Institute in Phoenix.”
  • Per a National Institutes of Health news release,
    • “A research team funded by the National Institutes of Health (NIH) has identified a diagnostic aid that has the potential to accurately predict the recurrence of diabetic foot ulcers that appear to be fully healed. By measuring the skin’s barrier function through a process known as trans-epidermal water loss, or TEWL, scientists were able to determine which wounds were more likely to reopen. TEWL measurements are a major factor in burn care, where deep layers of the skin are often damaged. The findings suggest that full restoration of skin barrier function should be incorporated into existing wound treatment standards to ensure complete wound closure and to better identify patients at risk of wound recurrence.
    • “This study is an important initial step to give clinicians treating diabetic foot ulcers a reliable diagnostic aid for the first time to assess an individual’s risk of ulcer recurrence,” said Teresa Jones, M.D. program director for the Division of Diabetes, Endocrinology, & Metabolic Diseases at NIH’s National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK). “Foot ulcers are such a confounding issue with diabetes and being able to determine which wounds are at highest risk for recurrence could save many lives and limbs.”  
  • NCQA, writing in LinkedIn, tells us,
    • The use of peer support is a growing trend for populations affected by mental health and substance use disorders. Peers—both paid and volunteer—have many of the same lived experiences as the people they serve, and can help them navigate the health care system, access treatment and overcome barriers to recovery.
    • Peers are another avenue of support in the behavioral care system—their shared experience related to mental health, addiction and recovery helps them build trust relationships. Many studies show the benefits of peer support: decreased days in inpatient care, increased engagement in outpatient treatment, reduced readmission rates and lower relapse rates.
    • “There’s a stigma associated with receiving mental health and substance use treatment,” says Chrissy Craig, MSPH, NCQA’s Senior Health Care Analyst. “Because of their lived experience, peers can connect with people who may not be ready to engage in traditional treatment approaches. They can build trust and encourage individuals to get the help they need.”
    • Recognizing the importance of peer support, NCQA has added it as an option for follow-up care in four HEDIS® measures:
      • Follow-Up After Emergency Department Visit for Substance Use (FUA).
      • Follow-Up After Hospitalization for Mental Illness (FUH).
      • Follow-Up After Emergency Department Visit for Mental Illness (FUM).
      • Follow-Up After High-Intensity Care for Substance Use Disorder (FUI) (MY 2026).
  • Per Health Leaders Media,
    • “An AI tool that can detect inflammation in the coronary artery could help clinicians diagnose heart disease much earlier, even decades before the patient shows any outward signs of distress.
    • “CaRi-Heart Technology, developed by Connecticut-based Caristo Diagnostics, was recently given its own Category III CPT code by the American Medical Association’s CPT Editorial Panel, an important step in the path to adoption after FDA approval and, just as important, payer reimbursement. The technology has also shown promising results in trials conducted in 2024 at five National Health Service hospitals in the UK, where reports indicate more than half of patients analyzed by the AI tool had their treatments changed.
    • “To clinicians, the tool could be a critical step forward in the diagnosis and treatment of heart disease, the leading cause of death in the country.”
  • The Wall Street Journal reports,
    • “Sanofi and Regeneron’s respiratory drug, itepekimab, showed mixed results in late-stage trials for COPD.
    • “One trial saw a statistically significant 27% reduction, while the other missed its primary goal with only a 2% reduction.
    • “Sanofi shares fell 7% and Regeneron shares dropped 12% after the results; future steps will be discussed with regulators.”
  • Per BioPharma Dive,
    • “A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn’t extend survival, complicating its potential path to approval in the U.S.
    • “When administered alongside chemotherapy, the drug, known as ivonescimab, reduced the risk of death or disease progression by 48% compared to chemotherapy alone in patients whose non-small cell lung cancer has a mutation in a gene called EGFR. However, a 21% reduction in death risk, specifically, didn’t meet the threshold for statistical significance, Summit said in a statement Friday.
    • “Summit intends to seek Food and Drug Administration approval based on the study results. Yet in its statement, the company indicated the timing of a filing is uncertain given the agency has made clear that a survival benefit is “necessary” to support a submission.”

Fromm the U.S. healthcare business front,

  • The actuarial consulting firm, Milliman, announced on May 27,
    • the release of the 2025 Milliman Medical Index (MMI), which measures healthcare costs for Americans covered by a typical employer-sponsored health insurance plan. Healthcare costs for the average person increased 6.7% in 2025, with pharmacy costs increasing by 9.7% and outpatient facility care costs rising 8.5%. Healthcare costs for a hypothetical family of four rose to $35,119.
    • “Pharmaceutical costs have been a leading driver of healthcare spending in recent years,” says Milliman Principal and Consulting Actuary Dave Liner. “This year, outpatient facility services and pharmacy costs together accounted for nearly 70% of the total cost increase. Much of the outpatient growth is linked to high-cost drugs administered in outpatient settings.”
    • In recognition of the MMI’s 20th anniversary, this edition includes a look back at how healthcare costs have evolved in the last 20 years. “Since we began publishing the MMI 20 years ago, healthcare costs for American families have nearly tripled,” says Milliman Principal and Consulting Actuary Deana Bell. “Annual growth has averaged 6.1%, far outpacing any other household expense. No other cost category has risen as steeply or as consistently over the past two decades. Outpatient facility care saw the largest increase of any category, rising 286% since 2005, reflecting the growing complexity of procedures now handled outside of inpatient settings.”
    • Read this year’s MMI.
  • An essayist writing in the Wall Street Journal, opines “America’s hospital-bed shortage is about to become a crisis. As new construction declines and occupancy rates soar, experts warn that hospitals may soon cease to function properly because of overcrowding.”
  • Modern Healthcare reports,
    • “Health systems, accountable care organizations and others are bringing extra staff and tracking technology into post-acute care to reduce hospital readmissions.
    • “Health systems, such as OSF Healthcare, and accountable care organizations, such as Provider Partners Connect Care are using remote patient monitoring equipment, electronic medical records software and additional staff to ensure patients don’t have a set-back that will send them back to the hospital. Readmissions add costs that ripple through the healthcare system and the Centers for Medicare and Medicaid Services penalizes hospitals and nursing homes for higher-than-predicted readmissions within 30 days of a hospital discharge.”
  • and
    • “UnityPoint Health, based in West Des Moines, Iowa, and MercyOne Siouxland Medical Center in Sioux City, Iowa, have signed a letter of intent for UnityPoint to acquire the medical center. The proposed agreement includes the hospital, its associated facilities, physician practices and home care services. The acquisition is expected to be finalized this summer, pending customary closing conditions.”
  • and
    • MDaudit, a cloud-based continuous risk monitoring platform that helps healthcare organizations reduce billing vulnerabilities and increase revenue, has entered into a definitive merger agreement to acquire Streamline Health Solutions, a provider of tools that help healthcare providers improve financial performance. The all-cash transaction is valued at approximately $37.4 million, including debt. The deal is expected to close in the third quarter.
  • Per Fierce Healthcare,
    • Women’s healthcare company Wisp has launched a diagnostics arm to offer low-cost testing at home for sexual and reproductive health, the company announced May 28. 
    • Wisp is an online platform that prescribes medication for a range of women’s health needs such as oral contraception, yeast infections, fertility, emergency contraception and some medication abortion. Women can pick up their prescriptions at the pharmacy on the same day as their request, following approval by a provider. Wisp also ships medications in discreet packaging. 
    • Wisp will now offer at-home tests for common sexually transmitted infections and free telehealth consultations for positive results, according to a release by the company. Patients will send completed urine tests or swabs to a partnered CLIA/CAP accredited laboratory and receive results in three to five business days. 
    • “The new model expands on Wisp’s direct-to-consumer telehealth platform and eliminates the need for patients to visit an in-person clinic to complete diagnostic testing. Patients can collect samples at home with tests sent in discreet packaging to maintain privacy in their healthcare and receive services entirely from home.”
  • and
    • “Talkspace inked a partnership with Amazon Pharmacy to streamline psychiatric medication fulfillment and home delivery for its members.
    • “It marks the first time a virtual behavioral health solution has integrated with Amazon Pharmacy, the companies said.
    • “Psychiatric patients of Talkspace can now have their medications fulfilled through Amazon Pharmacy and delivered to their homes for seamless medication management. Talkspace and Amazon Pharmacy tout the partnership will improve medication adherence for Talkspace members.” 
  • Per Healthcare Dive,
    • Best Buy reported $109 million in charges primarily linked to restructuring at the electronics retailer’s health unit in its first quarter, the company said in earnings released Thursday. 
    • The company began restructuring its health business after it recorded a non-cash goodwill impairment charge of $475 million in its fourth quarter ended Feb. 1, linked to a downward revision in the long-term financial projections for its health segment. 
    • The retailer partners with healthcare organizations to provide in-home health services, but the business has taken “longer to develop than we initially thought,” as providers grapple with financial challenges and the future of the federal government’s hospital at home waiver seems uncertain, Best Buy CEO Corie Barry said during a call with investors Thursday.

Thursday Report

David Ermer–CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Modern Healthcare relates,
    • “A coalition of healthcare trade associations and companies representing 550 providers and accountable care organizations is pleading with Congress to restore incentive bonuses for Medicare alternative payment models.
    • “The American Medical Association, Boston-based Mass General Brigham and others wrote congressional leaders Thursday expressing concern that failure to renew bonus payments will worsen providers’ financial instability, particularly in underserved regions.
    • “While we have seen steady growth for advanced [alternative payment models] in recent years, 2025 is a pivotal year for Medicare’s value transformation,” the letter says. “The expiration of Medicare’s advanced [alternative payment model] incentive payments and sharp increase in qualifying thresholds is creating significant challenges for physician practices and hospitals as they plan for the years ahead.”
  • BioPharma Dive reports,
    • “The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines against influenza strains seen as potential pandemic risks, leaving the future of the underlying research uncertain.
    • “Moderna revealed in a statement Wednesday that the HHS had terminated the contract, which could have handed the company more than $700 million in total funding. Moderna also reported that an experimental H5 avian influenza vaccine it’s developed showed promising results in an early-stage clinical trial. But without the government’s help, it will now be forced to “explore alternatives for late-stage development and manufacturing.”
    • “While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis,” said CEO Stéphane Bancel, in a statement. “These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.”
  • Govexec tells us,
    • “Federal job applicants will soon be quizzed on their favorite Trump administration policy as part of the hiring process, according to the Office of Personnel Management’s new “merit hiring plan.”
    • “How would you help advance the president’s executive orders and policy priorities in this role?” asks one of four essay questions that job seekers must answer if they are seeking any federal position GS-5 or above. “Identify one or two relevant executive orders or policy initiatives that are significant to you, and explain how you would help implement them if hired.”
    • “The federal government’s dedicated HR agency published the plan via a joint memo from Vince Haley, director of President Trump’s Domestic Policy Council and acting OPM Director Charles Ezell. The document is a hodgepodge of bipartisan reforms developed under both Trump and former President Biden to accelerate and improve the hiring process, alongside plans to eradicate longstanding efforts to make the federal workforce more reflective of the American populace.”
  • Tammy Flanagan, writing in Govexec, discusses what the latest FERS changes found in the budget reconciliation bill mean for federal and postal employee retirement benefits.
  • The Congressional Budget Office announced its 2025 panel of health advisors.
  • STAT News informs us,
    • “The White House will fix errors in a much-anticipated federal government report spearheaded by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., which decried America’s food supply, pesticides and prescription drugs.
    • “Kennedy’s wide-ranging “Make America Healthy Again” report, released last week, cited hundreds of studies, but a closer look by the news organization NOTUS found that some of those studies did not actually exist.
    • “Asked about the report’s problems, White House press secretary Karoline Leavitt said the report will be updated.
    • “I understand there was some formatting issues with the MAHA report that are being addressed, and the report will be updated,” Leavitt told reporters during her briefing. “But it does not negate the substance of the report, which, as you know, is one of the most transformative health reports that has ever been released by the federal government.”
  • The International Foundation of Employee Benefits Plans discusses what the President’s April 15 executive order on PBM transparency means for employers and other purchasers of PBM services.
  • Per Fierce Pharma,
    • “Six years after being spun out from Novartis and becoming a public company, eye care specialist Alcon has gained its first FDA approval for a prescription drug, scoring a nod for dry eye disease (DED) treatment Tryptyr (acoltremon ophthalmic solution).
    • “Tryptyr, which is administered as a single drop twice daily, is a first-in-class TRPM8 receptor agonist intended to activate tear production. 
    • “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of (DED),” Marjan Farid, M.D., professor of ophthalmology at the University of California, Irvine, said in a release.
    • “There are roughly 38 million in the U.S. who have DED. Fewer than 10% of those who have been diagnosed are being treated with a prescription product, according to Alcon.”

From the judicial front,

  • Chain Drug Review reports,
    • “Express Scripts, a Cigna-owned pharmacy benefit manager, and CVS Health have filed separate lawsuits against the state of Arkansas, seeking to halt the implementation of a new law that would bar PBMs from owning, managing, or controlling pharmacies within the state. 
    • “In a statement, CVS Health said the “unconstitutional law puts local politics ahead of patients, restricting their access to life-saving medications and undermining fair competition.“
    • “The lawsuits, filed Thursday in the U.S. District Court for the Eastern District of Arkansas, argue that the law, scheduled to take effect in 2026, is unconstitutional under multiple provisions, according to Modern Healthcare. Both companies claim the legislation would lead to significant disruptions in pharmacy access, workforce displacement, and increased medication costs.”
    • FEHBlog note — Good luck, CVS and ESI.
  • The Groom Law Group, which represents ERIC in its federal court lawsuit challenging the problematic to say the least 2024 mental health parity amendments, brings us up to date on the litigation, which so far has been successful.

From the public health and medical research front,

  • The Wall Street Journal lets us know,
    • “Adults diagnosed with autism spectrum disorder experience a range of benefits, including improved self-understanding, reduced self-blame and enhanced communication with others.
    • “The diagnosis can lead to positive changes in relationships, as individuals can now better explain their needs and behaviors to loved ones.
    • “Adults with autism may make adjustments to their routines and social interactions to accommodate their sensory sensitivities and communication challenges.”
  • Cardiovascular Business points out,
    • “Smoking marijuana and eating THC-based gummies have a negative impact on a person’s vascular health, according to new research published in JAMA Cardiology. In fact, the impact appears to be comparable to the damage seen in some tobacco users.
    • “There is a popular belief that marijuana smoke is harmless,” wrote first author Leila Mohammadi, MD, PhD, a vascular specialist with the University of California San Francisco, and colleagues. “However, marijuana smoke contains many of the thousands of chemicals contained in tobacco smoke, along with fine particles that contribute to cardiovascular morbidity and mortality. As cannabis legalization increases, it is crucial to understand the public health and clinical implications of marijuana use.” * * *
    • “Click here to review the full analysis.”
  • Per MedPage Today,
    • “Use of the investigational non-opioid analgesic resiniferatoxin appeared to improve pain control in patients with advanced cancer who had intractable pain, though all patients experienced adverse events (AEs), according to an interim analysis of a first-in-human phase I trial.
    • “Among 19 patients with refractory cancer pain localized to the abdomen and/or lower extremities, a total of 213 treatment-emergent AEs were reported with a single intrathecal injection of resiniferatoxin, including 37 serious AEs in 14 patients, and at least one AE in all patients, reported Andrew J. Mannes, MD, of the NIH, and colleagues.” * * *
    • “In an accompanying editorial, Krishna B. Shah, MD, and Bilal Dar, MD, both of the Baylor College of Medicine in Houston, noted that the improvements in efficacy “exceeded thresholds typically considered clinically meaningful,” and that the drug has the potential to provide “durable, opioid-sparing analgesia while preserving functional and cognitive abilities.”
    • “These interim results “represent an important step toward expanding the therapeutic interventional opioid-sparing options for patients with refractory cancer pain,” they wrote.”
  • Medscape notes,
    • “Extreme fatigue, bone loss, and abdominal pain are real-world adverse events noted with the use of glucagon-like peptide 1 receptor agonists (GLP-1s) that may not have been apparent from the clinical trials.
    • “In a wide-ranging “meet the professor” lecture at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025, obesity expert W. Timothy Garvey, MD, the Charles E. Butterworth, Jr. professor and university professor at the University of Alabama (UAB) and director of the UAB Diabetes Research Center at Birmingham, Alabama, said these phenomena all point to the importance of close clinical management of people taking GLP-1s and to the dangers of online prescribing of these medications.
    • “You can’t engage in complications-centric obesity care unless you evaluate the patient for complications, which doesn’t happen with online availability of prescriptions,” said Garvey.”
  • Per BioPharma Dive,
    • “Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed that one patient in an ongoing Phase 3 trial had signs of liver stress.
    • “Lab tests showed the patient had grade 4 liver transaminase elevations that “appear to be resolving” without hospitalization or medical treatment and have since fallen to less dangerous levels, Intellia said in a filing with the Securities and Exchange Commission late Wednesday. “We continue to monitor these events as the Magnitude study progresses,” the company said.
    • “The Magnitude trial is testing Intellia’s experimental therapy in a type of deadly heart condition known as transthyretin amyloidosis with cardiomyopathy, or ATTR-CM. Intellia has already recruited 365 patients and plans to enroll a total of 765 by early 2027. Though the study is blinded, it’s likely that the patient with the potentially serious liver signals received treatment with Intellia’s therapy, analysts said.”

From the U.S. healthcare business front,

  • Fierce Healthcare tells us,
    • “Healthcare C-suite leaders are trying to keep pace with rapid changes in U.S. economic and regulatory policies in the first four months of the second Trump administration.
    • “Among 700 business executives across six industries, nearly half (48%) of business executives rank economic policy among the top three factors driving strategic change over the next one to two years, according to a new PwC May pulse survey. 
    • “For healthcare executives, persistent policy and market volatility is a bigger concern, with six out of 10 (61%) rethinking short-term business strategies due to economic policies.
    • “Leaders at healthcare organizations also cited a number of other factors affecting short-term strategic changes — AI and data regulations (56%), U.S. trade policy (44%) and U.S. federal government spending and budget policy (37%). Healthcare C-suite leaders seem less concerned about corporate tax policy, cited by 34% as a factor driving short-term strategic changes, as well as the U.S. antitrust and competition environment (24%), climate policy (22%) and U.S. immigration policy (22%).
    • “About half (48%) of the business executives surveyed expect the current uncertainty to last less than a year, but many anticipate it could extend through the next presidential election.” 
  • Modern Healthcare reports,
    • “Private practice is slowly fading as a way to do business, going the way of landline phones, bank deposit slips and fax machines.
    • “An analysis by the American Medical Association found the percentage of physicians in a practice wholly owned by physicians last year to be at the lowest level since the survey began in 2012. The AMA examined data from its biennial Physician Practice Benchmark Survey, most recently conducted in 2024.
    • “The percentage of physicians working in private practice has dropped below 45%.
    • “Of the remaining physicians surveyed, the highest percentage are employed by hospitals.
    • “Along with that shift, only 35% of physicians described their employment status as owners in 2024.”
  • The Wall Street Journal explains how Novo Nordisk lost its mojo in the GLP-1 drugs market.
    • “Novo Nordisk, once Europe’s most valuable company, is losing its grip on the anti-obesity market due to production issues and slow marketing.
    • “Eli Lilly’s weight-loss drug Zepbound has surpassed Novo Nordisk’s Wegovy in weekly U.S. prescriptions, and Lilly has a more promising pipeline.
    • “Novo Nordisk’s CEO was ousted, shares have tumbled, and the company faces challenges in R&D and direct-to-consumer marketing.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • ICER publishes Evidence Report on Treatment for Secondary Progressive Multiple Sclerosis
    • There are significant uncertainties regarding long term efficacy of tolebrutinib;
    • ICER estimates that treatment would achieve common thresholds of cost-effectiveness if priced between $3,250 and $5,900 per year.
  • Health Affairs concludes in a recent article,
    • “Because many value-based care programs in the US are fragmented, heterogeneous and complex, none are driving large-scale, systemic change. Clinical care redesign driven by value-based healthcare programs has been halting and has achieved far less than promised.
    • “A rising mood of despair over the ability to achieve a sustainable, high-value healthcare system is causing some to support interventions such as price controls and heavier regulation to drive down spending. However, a key missing ingredient in value-based reforms has been sufficiently nuanced information about the clinical context in which patients are treated. A primary challenge in finally achieving high value healthcare in the US is discovering how to harness the comprehensive and nuanced data generated in the provision of care, which is available in each patient’s EHR, to support systemic care redesign to achieve better outcomes at lower cost. Adding that key ingredient could be transformative.
    • “The system currently used to extract data from EHRs in the US, ICD-10-CM, does not adequately capture clinical detail and nuance. Gaps, limitations, and errors in describing healthcare today lead directly to our inability to accurately measure both the outcomes resulting from the care provided and the cost of that care. The WHO created and released ICD-11 to address these issues, and with an appropriate comprehensive extension such as ICD-11-CCL the ability to measure and attain value in healthcare would be achievable. However, even if the US loses access to ICD-11, there is another viable option. SNOMED CT is a comprehensive clinical terminology, optimized for the capture of clinical nuance, that uses architecture designed for computerized data analytics. It is already used to capture and store clinical content in EHRs and could be leveraged through the creation of a comprehensive code set to also extract and transmit data with all clinical nuance preserved. Such a system would overcome most, if not all, of the current limitations in ICD-10-CM and could empower existing value-based programs to improve the cost-effectiveness of healthcare.”
  • Per Fierce Healthcare,
    • “Retail giant Walmart is rolling out a new platform for insurers and benefit managers that’s designed to make it easier to encourage healthy eating.
    • “The tool, called Everyday Health Signals, is powered by artificial intelligence, analyzing a consumers’ retail history on Walmart.com to surface personalized feedback such as shopping lists and nutrition analyses. Given that the retailer sees 145 million customers each week in stores and online, it has a bevy of data to pull from, according to an announcement.
    • “Eligible customers can opt in to allowing Everyday Health Signals to dig into their shopping history, Walmart said.
    • “The program is initially launching in partnership with NationsBenefits, connecting its members to data they can use to meet key health goals. Walmart intends to expand to other insurers and benefits organizations in the future.”
  • and
    • “Humana is the latest major insurer to partner with digital sleep clinic Dreem Health to improve members’ sleep care.
    • “California-based Dreem Health was acquired by sleep diagnostics company Sunrise in December. The company already has partnerships with the country’s largest payers including Aetna, Blue Cross Blue Shield, Cigna, HealthNet, UnitedHealthcare and Medicare.
    • “Sunrise was built on the back of research conducted by Jean-Benoit Martinot, M.D., the father of Sunrise CEO and founder Laurent Martinot. The company developed a small device that patients are able to use to diagnose sleep disorders from anywhere—without the inconvenience of spending the night hooked up to wires in a lab—while still providing a near-similar level of information.
    • “Our dream today is to become the largest sleep clinic in the country,” said Laurent Martinot in an interview with Fierce Healthcare. “We already have the largest virtual care sleep clinic. We would like to become the No. 1 one place you go if you feel you are not sleeping well and you need some care.”
    • “The Sunrise device is a diagnostic tool that is able to measure jaw movements, muscle contractions and snoring noises (through a built-in mic) from the comfort of a patient’s own bed. It’s disposable and is able to record data for up to three nights. A report is generated after just one night of sleep, allowing a care team to engage and start next steps immediately.”
  • Modern Healthcare reports,
    • “Highmark Health is off to a challenging start to the year as its insurance business dinged the company’s bottom line during the first quarter.
    • “On Thursday, the privately held for-profit Blue Cross and Blue Shield licensee reported net income of $13 million, a steep decline from $194 million the prior year, as revenue rose 11% to $8 billion
    • “As we’ve seen with the nationals on the health plan side, elevated trends are here to stay,” said Carl Daley, chief financial officer and treasurer of Highmark Health.”
  • Per BioPharma Dive,
    • “Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company’s assets and intellectual property rights.
    • “ITeos has for years struggled to develop a cancer treatment that sufficiently impressed investors and its pharmaceutical partners. Two weeks ago, it said it was shelving its most advanced drug prospect, a TIGIT-targeting treatment developed with GSK.
    • “The immuno-oncology developer is the latest biotechnology company considering merger prospects or liquidatation of its assets this year. Others such as Cargo Therapeutics and Third Harmonic Bio have made their own plans to dissolve.”