Simplicity is a virtue.

From Washington, DC

• STAT News reports,
  •  “In the chapel of a homeless shelter, health secretary Robert F. Kennedy Jr. stood behind a lectern with a “Cancel Corruption” sign and lambasted local officials for mishandling the city’s homelessness and substance use crisis.
  • “Just 24 hours earlier, Kennedy was in the Oval Office, standing alongside President Trump, as the president signed an executive order calling for major changes to childhood vaccinations.
  • “The change in tone — from day to day and coast to coast — shows how Kennedy’s sprawling political messages tied to his Make America Healthy Again movement vary depending on the audience he is in front of.”
  • “In Los Angeles, Kennedy kept the message fairly local, speaking before conservative city officials and a mission group of roughly a hundred teenagers and praising the shelter he was visiting. But from Washington, Kennedy has become a spokesman of the administration’s more far-reaching policies: fewer vaccines for kids and more regulation of food additives, both announced on Monday from the nation’s capital, before he headed West.” 

• Per an HHS news release,
  • The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today announced $96.7 million in grants and cooperative agreements to strengthen behavioral health services and supports across the country. The awards provide funding for a range of behavioral health services and initiatives, including services for people with serious mental illness who are homeless, suicide prevention and early intervention, substance use disorder treatment, training and technical assistance, peer support, and disaster-related emotional support.
  • “Every American deserves the opportunity to recover and live with dignity,” said HHS Secretary Robert F. Kennedy, Jr. “These investments will expand access to treatment, strengthen behavioral health services, and help more people move from crisis to recovery. That is how we restore health, rebuild lives, and strengthen our communities.”

• Meritalk interviews the U.S. Office of Personnel Management’s Chief Information Officer Adam Starr.
  • “As CIO roles become more strategic, OPM CIO Adam Starr says agencies need to give technologists room to move faster, embed AI and security into the business, and create a culture that rewards measured risk.”
    
• Federal News Network relates,
  • “The Defense Logistics Agency’s five-year IT modernization journey reached an important milestone earlier this summer.
  • “DLA moved its catalog system off a 35-year-old COBOL-based system and onto a new modern platform.
  • “Adarryl Roberts, DLA’s chief information officer, said the agency will now have a system that will allow it to process data and requests much faster.”
• FEHBlog observation — This is another example of IT modernization that causes the FEHBlog to wonder why OPM cannot convert its outdated CLER system to the modern HIPAA 820 electronic transaction that allows carriers to reconcile premiums at the individual enrollee level.

• Fierce Healthcare tells us,
  • “Amid instability in the Affordable Care Act marketplaces, proponents of ICHRA have suggested that these models could help support risk pools. A new survey from the HRA Council adds to the body of evidence on the matter. 
  • “The council, a nonpartisan organization that pushes for expanded coverage options, released its latest look at trends around individual coverage reimbursement arrangements, or ICHRA, and found that a growing number of larger employers are considering it as an option.
  • “The larger employee base from these firms could bring more younger, healthier individuals into the market, adding greater stability to the risk pools that would be felt on the exchanges, according to the report.”

From the Food and Drug Administration front,

• The Hill reports,
  • “More cases have been linked to outbreaks of cyclospora that do not have an identified source, according to the Food and Drug Administration. The outbreak linked to iceberg lettuce, meanwhile, has expanded to two additional states. 
  • “There have been nearly 14,000 cases of domestically acquired cyclospora confirmed in the U.S. since May this year, the Centers for Disease Control and Prevention report. That’s well over the roughly 1,180 cases reported from May through August last year.
  • :Of this year’s cases, at least 9,480 were reported in the 17 states connected to the cyclospora outbreak traced back to iceberg lettuce, according to the FDA and the CDC. Two states, Maine and Massachusetts, were added to that tally late last week.
  • At least some of the nation’s cases are also linked to the ongoing cyclospora outbreaks that the FDA has been investigating. 
  • “There are seven active investigations into cyclospora outbreaks, the FDA’s tracking shows. Three – sickening 18, eight and two people, respectively – are listed as ended. Only the outbreak linked to iceberg lettuce has an identified source.
  • “Two outbreaks have grown, according to the FDA. One, which was first reported in early August, has grown to 11 cases. Another, from late July, has grown to 172 cases, up from 115. The FDA continues to conduct traceback in both outbreaks, as well as three other still active outbreaks.
  • “We may never know the cause of the outbreak. Because of how long it can take for people to experience symptoms, and the difficulties of sequencing cyclospora, investigations can “take a significant amount of time,” Gwen Biggerstaff, the deputy director of the CDC’s Division of Foodborne, Waterborne, and Environmental Diseases, previously explained.”

• MedTech Dive relates,
  • “Johnson & Johnson said Monday its Monarch bronchoscopy robot for lung cancer diagnosis received Food and Drug Administration clearance for a software update that adds several new features to the platform, including artificial intelligence tools designed to make pre-procedure planning more intuitive.
  • “Other improvements broaden compatibility with commonly used imaging systems and support navigation and targeting to help physicians address anatomical changes that can occur during the procedure.
  • “The Quest 3 update is the Monarch system’s fourth major software launch in the past 18 months, according to J&J.”
• and
  • “The Food and Drug Administration has selected Cadence, a software company that makes an artificial intelligence-assisted tool for hypertension management, as the second company for its digital health pilot. 
  • “The Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, exempts certain digital health devices from FDA premarket authorization requirements while allowing companies to collect real-world data through a related Medicare program. 
  • “Cadence, which announced the FDA’s selection last week, plans to report real-world data related to the safety, performance and patient outcomes associated with its device to help inform how clinical AI systems are built and regulated in the future.”

From the judicial front,

• On August 3, 2026, a Title VII class action was filed in the U.S. District Court for the District of Columbia against OPM Director Scott Kupor and his agency due to OPM’s exclusion of gender affirming care in the FEHB and PSHB programs.  On August 14, the Chief Judge granted the named plaintiffs’ motion to use pseudonyms and seal certain identifying information. On August 17, the District Court’s Clerk assigned the case to U.S. District Judge Amit T. Mehta.

From the public health and medical / research front,

• The Washington Post reports,
  • “More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
  • “Starting this week, that grueling regimen can be reduced to just one shot a week.
  • “Novo Nordisk announced Tuesday that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
  • More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
  • “Starting this week, that grueling regimen can be reduced to just one shot a week.
  • “The appeal of reducing 365 shots a year to 52 is obvious: greater convenience, less pain. Novo Nordisk says removing the daily requirement can create “a routine that feels more manageable.” 
  • “But there are other issues to keep in mind — most importantly, the risk of hypoglycemia, or low blood sugar, which Novo Nordisk said was a common adverse reaction in Awiqli clinical trials. Hypoglycemia can make people feel shaky, irritable, and, if the blood sugar gets very low, confused. It can be dangerous and can even cause death if it gets excessively low.
  • “Novo Nordisk announced Tuesday [August 11, 2026] that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
  • “Another factor is access: It is not yet clear which insurance plans will cover Awiqli and whether they will require patients to jump through hoops to qualify for coverage.”
    
• MedPage Today relates,
  • “Using a panel of 11 genes linked to pediatric cancer predisposition syndromes, researchers found pathogenic or likely pathogenic variants in 7% of newborns who later developed a solid or brain tumor.
  • “Targeted sequencing of this panel would identify approximately 1/27,000 infants who will develop cancer by age 8 years in the setting of a genetic cancer predisposition syndrome.
  • “Researchers said it is feasible to conduct genomic newborn screening universally.” * * *
  • “[E]arly identification of these children could alter their survival outcomes, Diller and team noted.
  • “It’s become clear over the past few decades that at least 10% or more of kids who develop cancer have genetic predisposition to cancer, and a good chunk of those kids are diagnosed in the first few years of life,” Diller told MedPage Today. “It predisposes them to very-early-onset cancers. So the clinical problem is, can we do anything other than wait for them to develop their cancers?”

• Health Day tells us,
  • “Ultra-processed foods might be linked to a higher risk of prostate cancer, a new study says.
  • “Men who ate the most ultra-processed foods had as much as a 34% higher risk of prostate cancer, compared to those who ate less, researchers reported recently in theAmerican Journal of Medicine.
  • “Among adult men in this nationally representative U.S. population, those who consumed higher amounts of UPFs had significantly higher risks of the subsequent development of prostate cancer,” said senior researcher Dr. Charles Hennekens, a professor of medicine and preventive medicine at Florida Atlantic University.
  • “These findings add to emerging evidence that UPFs have major adverse health effects and underscore the need for large-scale observational studies and randomized trials to adequately test the hypothesis,” Hennekens said in a news release.”
• and
  • “A person’s sleep patterns could be an early sign of Alzheimer’s disease, a new study says.
  • “A greater number of micro-awakenings during sleep is linked to a greater genetic risk for Alzheimer’s, researchers reported recently in the journal Sleep.
  • “In fact, more frequent micro-awakenings go hand in hand with that genetic risk, long before any memory problems arise, according to a team from the University of Liege in Belgium. 
  • “Sleep could become an accessible marker for the early identification of vulnerable individuals,” senior researcher Gilles Vandewalle said in a news release.
  • “It’s well-known that people with Alzheimer’s have sleep problems, but sleep hasn’t been established as an early indicator of the disease, researchers noted.”

• The Wall Street Journal informs us,
  • “AstraZeneca AZN  said it is ending the Phase 3 trial of volrustomig plus chemotherapy for metastatic non-small-cell lung cancer.
  • “The Cambridge-based pharmaceutical company said Monday that the decision is based on the recommendation of the Independent Data Monitoring Committee after a planned review of trial data.
  • “The committee concluded that the volrustomig combination was unlikely to reach either of the primary endpoints for the drug in the eVolve-Lung02 trial.” * * *
  • “The other Phase 3 volrustomig trials will continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.
  • “Separately, AstraZeneca said Tagrisso plus Orpathys showed a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival in a Phase 3 trial in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer.” * * *
  • “The company said this was the first global Phase 3 trial to show significant progression-free and overall survival benefits in this setting.
  • “Tagrisso plus Orpathys is being jointly developed with Hutchmed, but is being solely commercialized by AstraZeneca.
  • “AstraZeneca also said a Phase 3 trial of Enhertu showed a significant and clinically meaningful improvement in progression-free survival as a treatment for unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small-cell lung cancer.”

• BioPharma Dive points out,
  • “Shares for Argenx soared over 13% Monday morning after the company announced positive data from a Phase 3 trial for a rare autoimmune condition that could expand use of its blockbuster drug Vyvgart. 
  • “The Dutch biopharmaceutical company said Monday an under-the-skin injection version of Vyvgart, called Vyvgart Hytrulo, met its primary endpoint in a late-stage combined study of people with myositis, a rare autoimmune disease that attacks the muscles and has limited treatments. The company said that Vyvgart, when compared to placebo, showed improvements in two subsets of the disease, as measured by a scale evaluating muscle strength and physical health known as Total Improvement Score, or TIS.”
• and
  • “EyePoint, a Boston-area biotechnology company, lost nearly a billion dollars in market value Monday after its main drug failed to hit the central goal of a key clinical trial.
  • “Titled LUGANO, the trial enrolled roughly 400 people with the less common “wet” form of age-related macular degeneration, meaning they have impaired vision because of abnormal, fluid-leaking blood vessels in their eyes. They received inside-the-eye injections of either “aflibercept,” the active ingredient in Regeneron Pharmaceuticals’ blockbuster medicine Eylea, or EyePoint’s drug, which the company has branded as Durayvu.
  • “Researchers then evaluated these participants for a little over a year, with a particular focus on any changes in average “best-corrected visual acuity” — a measure of how clearly a person, when outfitted with optimal prescription lenses, can read the kind of standard eye chart found in an optometrist office. EyePoint has now revealed that, on that measure, across the trial’s full dataset, its drug didn’t prove “non-inferior” to aflibercept.
  • “The company largely blamed the failure on an “asymmetric cohort” of nine patients in the Durayvu-treated group, who had vision loss — or a dropoff of at least 15 letters on the eye exam — that was “unrelated to wet AMD.” According to EyePoint, an after-the-fact analysis found the drug would have achieved non-inferiority had that group been excluded.”

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

• Fierce Healthcare reports,
  • “Kaiser Permanente reported nearly $1.7 billion in operating income (4.6% operating margin) during the second quarter of 2026, a more than $600 million improvement over the same period in 2025. 
  • “The country’s largest nonprofit health system, in a quarterly financial update shared Friday that precedes its more granular regulatory filing, outlined $35.6 billion in operating revenues, a 10.9% year-over-year increase, and nearly $34 billion in operating expenses, a 9.3% year-over-year increase.
  • “Kaiser noted that its structure as a membership-based, premiums-collecting integrated health system typically yields stronger operating income in the first half of the calendar year “due to health plan enrollment cycles,” moderating later on “as care utilization, labor costs, and other expenses increase while revenue stays relatively flat.”
  • “The quarter’s performance follows an opening frame in which the organization’s $711 million operating income (2.1% operating margin) reflected a pullback from early 2025’s $932 million operating gain (2.9% operating margin), due in part to a major month-long work strike. Year to date, that still places Kaiser and its subsidiaries about $400 million ahead of 2025. 
  • “In today’s complex health care environment, positive operating performance helps us make care more affordable, invest in our future, and expand access to value-based care,” Kaiser Permanente Chair and CEO Greg A. Adams said in a statement. “Together, Kaiser Permanente and Risant Health are helping more people benefit from evidence-based, coordinated care that improves quality, enhances the patient experience, and makes high-quality care more accessible and affordable. I’m grateful to our employees and physicians for bringing our mission to life every day.”

• Beckers Payer Issues relates,
  • “Blue Cross Blue Shield of Massachusetts earned $83.4 million in after-tax second-quarter profit. 
  • “This was made up of $35.7 million in operating and other income, as well as $47.7 million in investment income. The insurer’s revenue was $2.7 billion, marking a net margin of 3%. During the same period in 2025, BCBS Massachusetts had a $129.7 million loss on revenue of $2.6 billion.
  • “Since the beginning of the year, after-tax net income has been $142.9 million with revenue at $5.4 billion, a 2.7% net margin. The results include a premium deficiency reserve.
  • “After two consecutive years of record losses, we are also laser focused on restoring our company’s financial health,” Executive Vice President and CFO Ruby Kam said in an Aug. 14 news release. “We are doing this by carefully managing our own administrative costs and making necessary adjustments to our pricing and benefits.”

• Healthcare Dive tells us,
  • “Universal Health Services has completed its $835 million acquisition of online therapy provider Talkspace, bolstering the for-profit system’s already extensive behavioral health offerings.
  • “The deal closed Monday five months following its announcement, after the companies secured necessary regulatory approvals.
  • “With the buy, UHS will be able to provide a full range of behavioral health services, including inpatient, intensive outpatient, partial hospitalization, therapy sessions and virtual assessments.”

• Beckers Clinical Leadership adds,
  • “Salt Lake City-based Intermountain Health is approaching behavioral health access challenges by first addressing one quality concern in particular: whether patients are actually getting better.
  • “That’s the premise behind the health system’s push to embed measurement-based care across its behavioral health service line, Tammer Attallah, executive clinical director of Intermountain’s behavioral health clinical program, told Becker’s. The nonprofit system has locations in six primary states and additional operations across the western U.S., operating 34 hospitals and more than 400 clinics.
  • “We want more patients to get better faster. That’s all,” he said. “It’s as simple as that.” 

• Beckers Physician Leadership informs us,
  • “Three physician leaders shared what they believe healthcare organizations and the system as a whole need to stop asking of physicians, pointing to burdensome technology, systemic dysfunction and workflows that pull clinicians away from patient care. 
  • “James Augustine, MD. Medical Director for Lee County EMS (Fort Myers, Fla.): Mandated use of very unfriendly computer systems, which don’t contribute to good practice.
  • “Peter Bravos, MD. Chief Medical Officer of Sutter Health’s Surgery Center Division (Yuba City, Calif.): Asking physicians to personally absorb systemic dysfunction and calling it resilience. When the schedule is broken, the staffing is thin, and the administrative load keeps climbing, a wellness webinar isn’t a solution. It’s a way of relocating a system’s problem onto the individual and then measuring the individual for how well they cope with it. Resilience was never meant to be a substitute for fixing the conditions that exhaust people. Build systems worthy of the people working in them, and resilience takes care of itself.
  • “Walter Allen Fink, DO. Associate Vice President and Chief Medical Officer UT Health San Antonio: We need to stop putting unnecessary things between physicians and the work they were educated and trained to do.
  • “Too much physician time is spent working around inefficient processes, navigating technology, dealing with fragmented workflows, and doing tasks that do not really require a physician’s expertise.
  • “For me, this is bigger than just reducing administrative burden. We should be designing systems that allow physicians to spend more of their time caring for patients, making complex clinical decisions, talking with patients and families, and improving care.”
    
• Fierce Healthcare notes,
  • “Since April, more than 300 enterprise health systems have adopted Abridge’s artificial intelligence-based decision support solution, and the company is now making the tool available to every clinician at its partner health systems.
  • “It’s part of Abridge’s strategy to broadly expand from AI documentation to functioning as an enterprise AI assistant for clinicians.
  • “Adoption of decision support has outpaced anything we’ve shipped before because it feels like a natural extension of Abridge. It understands the context of the patient in front of the clinician, it’s grounded in the evidence they already trust, and it connects to what they want to do next,” Shiv Rao, M.D., CEO and co-founder of Abridge, and a practicing cardiologist, said in a statement.