Tuesday report

OPM

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, NIH, OPM, Patient safety, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC

  • Beckers Hospital Review reports,
    • “CMS awarded Alaska $160 million through the Rural Health Transformation Program, funding 142 projects to expand access to rural healthcare statewide.
    • “The funding package includes $6.5 million to bring the first robotic-assisted minimally invasive surgery program to Southern Southeast Alaska, $5 million to build a tribally led residential treatment and recovery campus in Southeast Alaska, and more than $3.1 million to deploy AI-powered medical imaging across 21 acute care hospitals for faster stroke detection.
    • “Alaska will also use $250,000 to develop a drone-based pharmaceutical delivery system for villages spread across 94,000 square miles, where medication deliveries can take five to 14 days during winter months. Nearly $4.6 million will strengthen the Alaska Family Medicine Residency Program, and $4.75 million will expand health information exchange connectivity for rural providers.”
  • Beckers Payer Issues relates,
    • “Nine months after President Donald Trump announced a deal offering states discounted pricing on GLP-1 drugs for Medicaid patients, most states are declining to participate, according to an Aug. 22 Politico report.
    • “Only Indiana has publicly signed on, while 29 state Medicaid programs have said they will not participate and 14 more did not respond to requests for comment, according to the report. CMS also declined to provide a list of participating states.” * * *
    • “Medicaid spending on GLP-1s grew from $1 billion in 2019 to almost $9 billion in 2024, and nearly 40% of patients with obesity could qualify for coverage if states opted in, according to the report. States that do not cover the drugs can still direct Medicaid enrollees to purchase them out of pocket through TrumpRx. The platform lists injectable Wegovy and Ozempic at average prices of about $350 a month, down from more than $1,000, though some pricing comparisons have found many listed drugs are available for less through existing Medicare Part D or Medicaid discounts. Even at the discounted rates, the drugs may remain unaffordable for many low-income patients.”
  • Beckers ASC Review tells us,
    • “The Federal Trade Commission has finalized a consent order requiring Ascension Health Alliance to divest seven Amsurg ASCs across five markets as a condition of its $3.9 billion acquisition of Amsurg, which closed in early June, according to an Aug. 25 news release from the FTC.
    • “The seven centers span Nashville, Panama City, Fla., Tulsa, Okla., Waco, Texas and Wichita, Kan. Six will be divested to Optum’s SC Affiliates, while the Panama City center will go to Florida Gastroenterology Center. The FTC alleged the acquisition would limit competition for outpatient surgical services performed by gastroenterologists, ophthalmologists and orthopedists in those markets, potentially leading to higher prices and lower quality of care. 
    • “The final order also requires Ascension to provide prior notice to the FTC before acquiring any additional ASCs in the metro areas around the divested centers. The Commission voted 2-0 to approve the final order.
    • “The deal, which expanded Ascension’s ASC footprint from 58 to more than 300 centers across 34 states, gives the St. Louis-based health system one of the largest ASC networks in the country.” 
  • SHRM informs us,
    • “The U.S. Department of Labor (DOL) has finalized three rules dismantling or scaling back longstanding affirmative action requirements for federal contractors, completing a major piece of the White House’s effort to reshape federal equal employment opportunity enforcement.
    • “Published in the Federal Register Aug. 21, the rules address three pillars of the regulatory framework administered by DOL’s Office of Federal Contract Compliance Programs (OFCCP): Executive Order 11246, Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA).” * * *
    • “For contractors, the result is a substantially different compliance landscape — one with fewer federally mandated affirmative action metrics and data-collection requirements. However, there remain continuing obligations to prevent unlawful discrimination and, in the disability and protected-veteran contexts, enduring statutory affirmative action duties.”

From the U.S. Office of Personnel Management front,

  • OPM published in today’s Federal Register the following final rule corrections:
    • Improving Performance, Accountability and Responsiveness in the Civil Service, and Recruitment and Relocation Incentive Waivers; Correcting Amendments FR Document:2026-17334 Citation: 91 FR 54796 PDF Pages 54796-54797 (2 pages) Permalink
    • Reduction in Force Appeals; Correction FR Document:2026-17338 Citation:91 FR 54796 PDF Page 54796 (1 page) Permalink
    • Reduction in Force; Correction FR Document:2026-17335 Citation:91 FR 54794 PDF Pages 54794-54796 (3 pages) Permalink
    • Streamlining Probationary and Trial Period Appeals; Correction and Technical Amendment FR Document:2026-17336 Citation: 91 FR 54793 PDF Pages 54793-54794 (2 pages) Permalink
    • Suitability Action Appeals; Correction. FR Document:2026-17337 Citation:91 FR 54798 PDF Page 54798 (1 page) Permalink
  • OPM Director Scott Kupor added another post to this Secrets of OPM blog (Substack link).
    • “This week, the Partnership for Public Service published an analysis claiming that agencies paid employees to leave through the Deferred Resignation Program (DRP) and then quietly hired their replacements. This is a claim that has surfaced frequently in the media in the past year: that the DRP reductions were not real because of backfills.
    • “The Partnership’s own analysis, however, confirms that these claims have no merit.
    • “According to OPM’s workforce data, 139,928 employees participated in the DRP. The Partnership identifies 20,557 subsequent hires that it considers “backfills.” Even accepting that figure at face value – the Partnership is using broad job classifications that can often encompass hundreds of actual jobs as a very imperfect proxy that likely significantly overstates actual backfills – it amounts to 14.7 percent of DRP participants.
    • Thus, more than 85 percent of employees who took the program are not matched to any subsequent hire. That’s pretty good for a program that was rolled out government-wide. Simply put, 85% of the reductions were real and lasting.”

From the Food and Drug Administration front,

  • Reuters reports.
    • “The U.S. Department of Health and Human Services is planning to appoint two new deputy commissioners at the Food and Drug ​Administration, CNBC reported, citing sources familiar with the ‌matter.
    • “One role would focus on technology, including healthcare and AI, while the other would oversee drugs, according to two people familiar with the plans.”
  • Per Fierce Pharma,
    • “Jazz Pharmaceuticals’ bispecific antibody Ziihera has gained FDA approval for first-line HER2-positive stomach cancer, unlocking another market as the company builds toward a $2 billion-plus peak sales target. 
    • “The latest green light allows Ziihera to be used in addition to chemotherapy, with or without BeOne Medicines’ Tevimbra, in previously untreated, HER2-positive advanced gastroesophageal adenocarcinoma (GEA). 
    • ‘The approval permits Jazz to challenge more than a decade of practice, in which trastuzumab (Herceptin) has been the standard HER2 agent used alongside platinum-based chemotherapy—with or without a PD-1 inhibitor—as first-line therapy for these stomach cancer patients.” 
  • The Hill tells us.
    • “Vitruvias Therapeutics is voluntarily recalling one lot of thyroid tablets because they could potentially be “superpotent,” federal regulators announced this week.
    • “The high potency 30mg tablets could cause hyperthyroidism, or an overactive thyroid, according to the Food and Drug Administration. The affected lot (504950) was distributed nationwide to Vitruvias Therapeutics’ direct accounts from Jan. 31 to Sept. 30, 2025.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The Libre Duo 10 Day is the first wearable device in the U.S. that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar (glucose) together in a single device.
    • “Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency.”
    • “According to the Centers for Disease Control and Prevention, an estimated 40.1 million Americans are living with diabetes, a condition that requires careful monitoring of blood sugar levels. For the estimated 2.1 million Americans with type 1 diabetes, blood sugar is only part of the picture. When the body produces too much ketone, which is made by the body when it is using fat instead of glucose for energy, it can lead to diabetic ketoacidosis, or DKA — a serious complication that can develop quickly and become life-threatening if left untreated.”
  • Beckers Hospital Review points out,
    • “The FDA cleared Amygdala Neurosciences’ Investigational New Drug application for ANS-858, allowing the company to move the drug into clinical development.
    • “ANS-858 is a selective, reversible, orally bioavailable inhibitor of aldehyde dehydrogenase 2 (ALDH2), according to an Aug. 18 news release from the company. It plans to begin a phase 1 clinical trial, which is designed to support later evaluation of ANS-858 across multiple indications in phase 2 clinical trials.
    • “Amygdala Neurosciences is initially advancing ANS-858 as a potential treatment for alcohol use disorder and other substance use disorders. It is also evaluating the drug in compulsive eating disorders associated with binge eating and obesity.”
  •  Cardiovascular Business informs us,
    • “Young M. Lee, MD, a cerebrovascular surgeon with University Medical Center New Orleans, was the first U.S. physician to perform a stroke thrombectomy with Thunderbolt, a computer-assisted vacuum thrombectomy (CAVT) system from Penumbra that gained U.S. Food and Drug Administration (FDA) clearance back in June. 
    • “Lee performed the procedure on a young male patient who presented with a right middle cerebral artery (MCA) syndrome and a right M1 occlusion. He spoke to Cardiovascular Business about the experience, noting that this first patient was an especially challenging case due to preexisting intracranial atherosclerotic disease.
    • “I was able to observe the Thunderbolt essentially detect the clot and completely aspirate the clot starting from its proximal end in the mid-M1 segment all the way up to the point of the MCA bifurcation,” he explained. “With the fluoroscopy running, I could see the aspiration catheter advance towards the MCA bifurcation as the pump responded to what was happening, which is not something you see with a traditional non-modulated aspiration technique.”

From the judicial front,

  • Federal News Network reports,
    • “The Trump administration is facing a new lawsuit from federal unions after it issued a pair of recent final rules overhauling federal employee suitability standards and performance evaluations.
    • “Filed on Monday in the U.S. District Court for the Northern District of California, the unions’ lawsuit contends that the Office of Personnel Management exceeded statutory authority and violated the intent of the Civil Service Reform Act when it issued regulations to change suitability and fitness regulations and reshape the performance management system for the federal workforce.
    • “Taken together, the changes will make it easier for OPM and agencies to fire federal employees, while limiting opportunity for employees to challenge their removals or other adverse actions, the unions argued. Their lawsuit is the latest of several legal challenges unions are taking against the Trump administration’s efforts to revise federal workforce policies and regulations.
    • “The American Federation of Government Employees is leading the lawsuit, with other plaintiffs including the National Federation of Federal Employees (NFFE), the International Federation of Professional and Technical Engineers (IFPTE) and the American Federation of State, County and Municipal Employees (AFSCME).”
  • Per a Justice Department news release,
    • “The Department of Justice today announced the emergency scheduling of three highly potent opioid compounds that pose an imminent hazard to public safety: mitragynine pseudoindoxyl, commonly known as MGPI, and two synthetic compounds known as MGM-15 and MGM-16.
    • “The Justice Department is acting before these dangerous compounds become a broader threat,” said Attorney General Todd Blanche. “These are potent opioids being manufactured and sold in consumer products, often under labels that obscure their true risks. This action will protect our nation’s children and communities from the dangers of drug addiction and abuse.”
    • “The Drug Enforcement Administration is temporarily placing the three 7-hydroxymitragynine-related substances in schedule I of the Controlled Substances Act. Preclinical evidence indicates that all three are potent mu-opioid receptor agonists and may present risks associated with other mu-opioid agonists, including dependence and respiratory depression. MGPI and MGM-15 are manufactured and marketed in products sold for their opioid effects. MGM-16 has not been confirmed in the consumer market but is a highly potent compound that could emerge as a substitute for related substances.”
  • The New York Times adds,
    • “Since the early 2000s, the number of fatal overdoses in the United States has soared. And the rate in Baltimore — 110 deaths per 100,000 residents, according to a recent analysis by the San Francisco Chronicle — is the highest among cities with a populations of a half-million or more.
    • “The initial cause was prescription opioids, then heroin, and then, starting a decade ago, a new generation of synthetic opioids, mainly fentanyl. Now, new combinations of ultrapotent lab-made drugs reach the street almost daily, making the narcotics supply — in Baltimore and beyond — more dangerous, polluted and unpredictable than it has ever been.” * * *
    • “Because lab-made drugs are so easily mixed and altered, their effect is uncertain; few buyers know what they’re actually getting, and the possibilities are expanding dangerously. Last summer, several mass overdoses in Baltimore resulted when fentanyl was mixed with N-methylclonazepam, a powerful sedative. Across the country, 22 percent of drug samples contained five or more compounds, an increase from 8.8 percent in 2022, according to testing done by the National Institutes for Science and Technology.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Two unvaccinated people in Pennsylvania have died after contracting measles, the state health department said, the U.S.’s first measles-associated deaths reported this year.
    • “Both of the people lived in Lancaster County, a populous area in the southeast part of the state known for its large Amish community, the health department said Tuesday. The deaths mark Pennsylvania’s first measles-related fatalities in 35 years and are part of a larger outbreak in the state. 
    • “Pennsylvania has confirmed more than 390 cases of measles across 28 counties so far this year, all in people who weren’t fully vaccinated. Nearly half have come from Lancaster County. About a third of the Pennsylvanians affected are under 18 years old.
    • “I want to be clear: This illness and death from measles is completely preventable,” said Pennsylvania Gov. Josh Shapiro. “We already have the tools to protect ourselves and our families from this disease, which is one of the most contagious diseases on the face of the earth.”
  • The National Institutes of Health’s Research Matters covers the following topics in its latest issue.
    • “Dementia-free years may decrease with smoking, hypertension, and diabetes.
      • “Researchers found that smoking, high blood pressure, and diabetes in midlife lower the number of years a person is likely to live without dementia.
      • “The findings could help guide behavior and lifestyle changes to prevent dementia.
    • “Coating stops tooth decay in children.”
      • “A clinical trial found that a topical treatment called silver diamine fluoride stops cavities in young children from getting worse.
      • “The simple treatment could prevent surgery and other serious consequences for children with severe tooth decay.”
    • “DNA organization changes in Alzheimer’s disease, aging.”
      • “New research showed the 3D organization of DNA in cells changes in Alzheimer’s disease and aging.
      • “The results suggest the changes may contribute to altered gene activity observed in Alzheimer’s and aging.”
  • Health Day relates,
    • “A combo of hormone therapy and targeted drugs appears to help patients with metastatic breast cancer
    • “About 97% of patients benefited during the first six months
    • “The treatment, mainly using pills and under-the-skin injections, could eventually offer some patients an easier first-line option.”
  • and
    • “Hoping for a quick response from your doctor to a message sent through your patient portal?
    • “Then keep it cordial and positive, a new study suggests.
    • “Doctors were more likely to respond to messages that addressed them by name and had a positive tone, researchers reported Aug. 24 in JAMA Network Open.”
  • Beckers Hospital Review lets us know,
    • “Pediatric medications have more active FDA-listed shortages than any other therapeutic category, according to the FDA’s drug shortage database.
    • “Here are the categories with the most active shortage listings, ranked by number of active shortages as of Aug. 25:
      • 1. Pediatric: 18
      • 2. Anesthesia: 10 (tie)
      • 2. Cardiovascular: 10 (tie)
      • 3. Analgesia/addiction: 9 (tie)
      • 3. Gastroenterology: 9 (tie)
      • 4. Endocrinology/metabolism: 8 (tie)
      • 4. Neurology: 8 (tie)
      • 5. Anti-infective: 7 (tie)
      • 5. Oncology: 7 (tie)
      • 5. Psychiatry: 7 (tie)

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

  • Beckers Payer Issues reports,
    • “Most large health insurers posted stronger-than-expected earnings in the second quarter, but much of the improvement might not be durable, according to a Moody’s Ratings analysis published Aug. 24.
    • “Average EBITDA margins across the seven largest publicly traded insurers rose to 4.7% in Q2, up from 3.9% in the same period a year earlier. UnitedHealth Group posted the largest swing, expanding to 6.2% from 3.7%, while Centene jumped to 3.7% from 0.6% on the back of marketplace margin recovery and outperformance in its Medicare Advantage and prescription drug plan businesses. Five of the six insurers that reported results raised or affirmed full-year guidance.
    • “The rating agency cited high-cost specialty drugs, sustained behavioral health demand and aggressive provider billing and coding as ongoing pressures. The report also described a “clear industry pivot toward margin stabilization rather than top-line growth,” calling the shift broadly credit positive.”
  • Beckers ASC Review adds,
    • “For nearly as long as health insurers have used prior authorization to control costs, physicians and hospitals have argued it does more harm than good. 
    • “The pushback against prior authorization has reached new heights in recent months as healthcare leadership, legislators and physician advocacy organizations have proposed major reforms or outright bans of the practice.” 
  • Healthcare Dive relates,
    • “Name: Dr. Patrick Fox
    • “Previous title: President, Wellpoint New Jersey
    • “New title: President, Carelon Behavioral Health
    • “Fox is assuming the top role at Elevance’s behavioral health division effective immediately, the Indianapolis-based insurer announced Monday.”
  • Beckers Hospital Review tells us,
    • “New York City-based NewYork-Presbyterian reported operating income of $124.2 million (4% operating margin) during the second quarter of 2026, up from $101.7 million (3.6% margin) during the same period last year, according to its Aug. 24 disclosure report.”
  • and
    • “Orlando (Fla.) Health recorded operating income of $81.5 million (3.0% operating margin) in the third quarter of fiscal 2026, up from $56.3 million (2.2% margin) during the same period last year, according to its Aug. 25 finance report.”
  • and
    • “As health systems continue to grapple with financial pressures from rising labor and supply costs and reimbursement challenges, days cash on hand remains an important measure of financial stability. 
    • “[The article shares} days cash on hand figures for 25 health systems as of June 30, according to their most recent financial reports”
  • Fierce Healthcare tells us,
    • “The Oregon Health Authority (OHA) approved a deal on Monday that would merge the nonprofits MultiCare Health System and Samaritan Health Services.
    • “State regulators said the OHA’s Health Care Market Oversight (HCMO) program reviewed how the proposed merger would affect Samaritan’s facilities and its impact on Oregon citizens’ access to affordable and equitable healthcare. 
    • “HCMO approved the deal provided it meets established conditions (PDF), including requiring MultiCare to follow its financial commitment of investing $700 million towards Samaritan and posting a public-facing version of the commitment on Samaritan’s website. Other conditions involve reinvestment of Samaritan’s operating margins into local communities and a requirement to maintain existing services.”
  • and
    • “Artificial intelligence-driven specialty care navigation platform Switchboard Health announced Tuesday the acquisition of virtual orthopedics and musculoskeletal (MSK) management provider Livara Health.
    • “Switchboard Health will embed Livara’s MSK program in its automation platform for referral management and care navigation, through the acquisition, to enable providers and health plans to enroll patients.
    • “Financial details of the transaction were not disclosed.”
  • Beckers Physician Leadership informs us,
    • More than half of active U.S. physicians worked for hospital systems as of 2024, up from 20% in 2010, and hospital systems have acquired more than 20,000 physician practices since 2015, according to a recent study published in JAMA Network Open.
    • Becker’s ASC Review tracked more than 50 physician practice deals in 2026 — with consolidation taking over some areas of medicine more than others. 
    • [The article provides] a breakdown by across five specialties.

Notable Death

  • The Wall Street Journal reports,
    • “One night in 1973, Dolly Parton had a song on her mind. She was thinking about a bank teller who had been flirting with her spouse.
    • “She got this terrible crush on my husband,” Parton told NPR in 2008. “And he just loved going to the bank because she paid him so much attention.”
    • “Needing a name for this tall, redheaded temptress, she thought of another flame-haired girl, an 8-year-old who approached her for an autograph after a taping of “The Porter Wagoner Show,” the TV series on which she was featured. That child’s name was Jolene.
    • “Parton died Tuesday at age 80 in Nashville, Tenn., according to her family. The cause of death wasn’t released. In May, Parton canceled a Las Vegas residency because of health issues.”
  • Beckers Hospital Review adds,
    • “Beyond her music and film career, Ms. Parton spent decades directing philanthropic dollars toward hospitals and medical research, much of it concentrated in her native East Tennessee and at Nashville-based Vanderbilt Health. [The article shares] seven ways her giving left an imprint on healthcare.

Monday report

David Ermer–Agentic & Generative AI, CMS, Federal employment benefits, Medicare, OPM, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $144 million investment is being delivered to improve health outcomes for Alabamians through the federal Rural Health Transformation Program (RHTP) This investment will support 138 grants to expand access to care, modernize healthcare technology and infrastructure and strengthen the rural healthcare workforce.
    • “This funding will help rural providers modernize their technology and cybersecurity, enhance telehealth and mobile care services, strengthen emergency and maternal care, and improve access to mental health and substance use care. The Trump Administration is also investing in expanding the healthcare workforce through training, scholarships, apprenticeships, and recruitment efforts, while helping local providers strengthen community-based care and better coordinate services. These investments will help make healthcare more accessible, connected, secure and sustainable across Alabama regardless of your zip code.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. and Secretary of Agriculture Brooke L. Rollins today announced sweeping new efforts to strengthen school meals by connecting more American farmers with local schools, investing in school kitchen infrastructure, and giving states and school districts new tools to serve healthier, more nutrient-dense meals to America’s children.
    • “Secretary Kennedy joined Secretary Rollins at the U.S. Department of Agriculture (USDA) alongside farmers, students, school nutrition leaders, athletes, chefs, and parents to announce the next phase of the Trump Administration’s work to Make America Healthy Again.” * * *
    • “If we want to Make America Healthy Again, we have to start with our children, and that means improving what we put on their lunch trays every single day,” said Secretary Brooke L. Rollins. “Harvest to Hallways is about bringing more American agriculture into the school cafeteria. We are connecting schools with the farmers and ranchers in their own communities, investing in the kitchens and equipment school nutrition professionals need to prepare real food, and cutting through barriers that have made it too difficult to serve healthy, American-grown food. When we strengthen the connection between the farm and the lunchroom, everybody wins: our children eat better, our farmers gain new markets, and our communities grow stronger.”
  • STAT News adds,
    • “New restrictions on the use of food benefits to purchase soda and candy have been one of the biggest changes enacted by the Make America Healthy Again movement. But a key question has been how profoundly the bans would affect public health, with some economists arguing that people would just use other funds to buy Coke and other sugary drinks instead.
    • “Now a new study shows that soda purchases did indeed fall by about 12% among people who receive Supplemental Nutritional Assistance Program benefits after the bans went into effect in 10 states. The study, which was published by the National Bureau of Economic Research and has not yet been peer-reviewed, says this translates to a person drinking about 34 fewer 12-ounce cans of soda per year.”
    • “That’s not huge, according to the study’s authors, but it’s far from nothing.”
  • Beckers Hospital Review reports,
    • “More than 200 healthcare organizations urged CMS not to finalize proposed limits on remote monitoring, warning the changes would disrupt care for about 1 million Medicare beneficiaries who manage chronic conditions from home.
    • “In a sign-on letter to CMS Administrator Mehmet Oz, MD, the coalition asked the agency to hold off on remote physiologic monitoring and remote therapeutic monitoring policies included in the 2027 Medicare Physician Fee Schedule proposed rule. More than 30 health systems and hospitals signed the letter. 
    • “The provision at issue, proposed July 14, would allow clinical practices to bill Medicare for the services only if the clinical staff delivering them are directly employed by the billing practice rather than contracted through a third-party vendor. Staff could still work off-site; the billing relationship would have to run in-house.
    • “That distinction carries broad reach. An estimated 60% to 70% of hospitals and health systems using remote monitoring rely on partially or fully outsourced vendor models, according to Becker’sprior reporting. The signers of the letter said small practices, rural providers and safety-net organizations would be hit hardest, and that many would have no option but to cut enrollment or end their programs.”

From the U.S. Office of Personnel Management front

  • FedWeek reports,
    • “President Trump has not yet sent Congress the alternative pay plan letter that will determine the 2027 federal pay raise, and the statutory deadline to do so arrives August 31. The letter is the clearest remaining signal of whether federal employees face a full pay freeze next year or another modest increase similar to the one delivered a year ago.
    • “Under the Federal Employees Pay Comparability Act (FEPCA) of 1990, the president must submit an alternative pay plan to Congress by the end of August, or a statutory formula tied to private-sector wage growth automatically takes effect instead, producing a far larger locality pay increase than any administration has allowed to take hold since the law passed. FedSmith has explained the mechanics of this deadline before, and last year’s letter covering the 2026 raise arrived on August 28, just three days before the cutoff. A similarly late announcement is likely again this year.”
  • and
    • Federal employees under the General Schedule receive a base salary plus a locality payment that varies by geographic area. The 2026 rates range from 17.06% in the Rest of U.S. locality pay area to 46.34% in the San Jose-San Francisco-Oakland, CA, locality pay area.
    • “The federal locality pay system adjusts General Schedule salaries to reflect differences in non-federal pay levels across geographic regions. Authorized by the Federal Employees Pay Comparability Act of 1990, the system took effect in January 1994. Its purpose is to reduce pay disparities between federal and non-federal workers performing similar work in the same labor market.
    • “Locality payments are calculated as a percentage of base pay and applied according to the employee’s official worksite. The Office of Personnel Management publishes annual tables that incorporate both the across-the-board base pay increase and the locality adjustment for each designated area. For 2026, locality pay percentages remain at the prior year’s levels, while base pay received a 1.0% across-the-board increase.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration cleared a blood test for identifying Alzheimer’s disease symptoms, which was developed by Roche and Eli Lilly.
    • “The Elecsys Phospho-Tau Plasma test identifies amyloid pathology associated with Alzheimer’s in people 55 years or older.
    • “It provides positive, intermediate and negative result categories to support doctors assessing the likelihood of amyloid pathology. Results are interpreted in conjunction with clinical information and other relevant findings as part of an Alzheimer’s diagnosis.
    • “The blood test is meant to address the gap in diagnoses, as an estimated 75% of people living with dementia are undiagnosed, Roche said.
    • “Quest Diagnostics and Labcorp both said they plan to start offering the blood test.”
  • MedTech Dive relates,
    • “The Food and Drug Administration has picked two behavioral health companies to join its Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, growing the total number of participants to four.
    • “Limbic and Sondermind are the next companies to join the pilot program, which allows participants to gather real-world data on devices while being exempted from premarket authorization requirements.
    • “Amid the pilot program, the FDA has also held discussions on digital health technologies for mental health, with patient groups calling for broader oversight in the use of generative artificial intelligence.”
  • Beckers Hospital Review tells us,
    • “The FDA has again paused Regenxbios RGX-121 gene therapy trial for Hunter syndrome after small, asymptomatic masses were found on the spines of five patients. Regenxbio does not expect to resubmit its biologics license application for the therapy in the near term.
    • “The spine findings, either a small nodule or cystic mass, surfaced through an expanded MRI monitoring plan Regenxbio adopted a few months ago, according to an Aug. 24 news release. All five patients received intracisternal or intraventricular RGX-121 three to six years ago, remain asymptomatic and have shown stability to improvement on neurocognitive assessments. Investigators consider the findings nonserious and likely benign, though no pathological evidence confirms their cause.
    • “The pause comes seven months after Regenxbio disclosed that a boy who received its similar MPS I therapy, RGX-111, developed a brain tumor, a case researchers have since linked to AAV gene therapy, the vector platform used in most gene therapies over the past 20 years.”

From the judicial front,

  • Fierce Pharma reports,
    • “On Monday, the U.S. District Court for the District of Columbia ruled against Merck & Co., rejecting its claim that the price negotiations are unconstitutional because they violate the First and Fifth Amendments. The argument is one that has been made by multiple drugmakers pushing back against the program.” 
  • Per a Justice Department news release,
    • “Today, the U.S. Department of Justice announced the launch of the National Fraud Detection Center (NFDC), a prosecutor-led, multi-agency team designed to investigate the most harmful actors defrauding federal government programs, including illicit actors overseas and those operating fraud schemes across federal programs. The NFDC will bring together law enforcement agencies and analytical capabilities to generate criminal leads to drive more impactful prosecutions and enhance fraud-fighting results for the American people.
    • “The creation of the NFDC marks a decisive shift in how the federal government detects and investigates complex fraud,” said Assistant Attorney General Colin McDonald of the Justice Department’s National Fraud Enforcement Division. “By breaking down institutional silos, embedding analysts from across the IG community, and leveraging shared technology, the NFDC is actively closing the window of opportunity for bad actors who seek to exploit taxpayer dollars. Today’s announcement sends a clear message: if you defraud federal programs, we have the tools and the law enforcement partners to find you.”

From the public health and medical / Rx research front,

  • Beckers Hospital Review reports,
    • “A fast-moving wildfire in the Sierra Nevada foothills has forced two Northern Nevada Health System facilities in the Reno, Nev., area to evacuate patients and close, according to CBS News and The New York Times.
    • “Both facilities remain closed with no timeline to reopen. The health system said it is in active communication with emergency response teams and will reopen each facility once crews clear the area and deem it safe, at which point it will activate an opening plan and notify the community.”
  • Better Report tells us.
    • “We spoke with board-certified emergency medicine physician Dr. Joseph Radachy about what he wishes more patients would prioritize. From simple ways to avoid everyday accidents to daily practices that support long-term health, here are six things your doctor wishes you’d do.
      • Stay Active Physically and Medically
      • Make your House Safer.
      • Advocate for Yourself
      • Know your Medical History
      • Remember: Moderation in Everything
      • Stop Smoking
  • The New York Time asked experts whether the bland BRAT diet is the best way to treat a stomach bug.
  • The American Medical Association lets us know “what doctors want patients to know about dry eyes.
    • “Dry eye disease can cause burning, tearing and blurry vision. Learn what triggers symptoms, which treatments help and when to seek care.”
  • Beckers Behavioral Health informs us,
    • “The age-adjusted death rate for alcohol-induced deaths among U.S. adults aged 45 and older increased from 2014 to 2024, according to an Aug. 20 report from the CDC’s National Center for Health Statistics.
    • “Death rates increased from 19.5 per 100,000 population in 2014 to 25.2 in 2024. In 2024, the death rate was 36.8 among men and 14.3 among women. Death rates were higher among men than women throughout the 2014–2024 period.
    • “The findings are based on National Vital Statistics System mortality data.
  • Parkinson’s News Today points out,
    • “Parkinson’s disease involves the progressive loss of dopamine-producing neurons, leading to motor symptoms.
    • “Starting rehabilitation within the first year of a Parkinson’s diagnosis may be linked to longer survival.
    • “Delaying rehabilitation is associated with a progressively higher risk of mortality across all disability levels.”
  • Genetic Engineering and Biotechnology New notes,
    • “Cancer metastasis is responsible for at least two-thirds of cancer deaths. Drugs targeting the metastatic progression have largely failed, in part due to the lack of predictive models that would help identify the underlying mechanisms of metastasis.
    • “Now, new work reports the development of a multi-organ chip that mimics how cancer cells spread from vascular flow to distant organs—the first model of cancer metastasis of its kind. The chip includes compartments with millimeter-sized engineered human bone and lung tissues, and the vascular flow that contains circulating breast cancer cells and allows the dynamic cross-talk of the tissues being colonized.
    • “The key advantages of this advanced model of metastasis are that it is human and can be patient-specific,” said Gordana Vunjak-Novakovic, PhD, university professor and professor of biomedical engineering and professor of medical sciences at Columbia University. “It faithfully mimics some of the key aspects of human metastasis that are otherwise largely inaccessible for direct study.”
    • “This work is published in Science Translational Medicine in the paper, “Organ-specific colonization and niche remodeling in a human tissue model of metastasis.”
  • STAT News takes us “inside Moderna and Merck’s cancer vaccine triumph.
    • “The drugmakers overcame rampant doubts, logistical challenges, and the pandemic.”

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

  • Fierce Healthcare reports,
    • “Highmark Health closed the first half of the year with $17.5 billion in revenue and $2 billion in net income, bolstered by a significant turnaround at its insurance unit.
    • “The $2 billion in net income accounts for $911 million in non-cash gains from the company’s affiliations with Blue Cross and Blue Shield of Kansas City and Heritage Valley Health System.
    • “Highmark Health Plans posted $672 million in operating income through the first two quarters of 2026, an increase of $612 million compared to the first half of 2025. Highmark said in the announcement that it expects elevated utilization and cost trends to persist across the industry, though pressures have eased.”
  • and
    • “Berry Street, a nutrition care company, has merged with India-based Healthify to form what executives call the largest insurance-covered AI metabolic health platform in the U.S. 
    • “The merger combines Healthify’s AI technology, including its nutrition and metabolic health assistant Ria, with Berry Street’s nationwide network of more than 2,000 clinicians and insurance-covered nutrition and GLP-1 care. The companies say the goal is to offer AI-powered, clinician-backed metabolic health support accessible through health insurance.
    • “Financial details of the merger were not disclosed. Berry Street shared the news exclusively with Fierce Healthcare.”
  • Beckers ASC Review relates,
    • “Kaiser Permanente is advancing construction plans for its long-planned Redlands, Calif., medical campus, with the Redlands Planning Commission set to review detailed site plans for the project’s first building Aug. 25, Community Forward Redlands reported  Aug. 24.
    • “The commission will consider a 113,000-square-foot, three-story medical office and ASC at Kaiser’s existing property. The building, known as Medical Office Building/Ambulatory Surgery Center 2, would house urgent care, outpatient surgery, chemotherapy infusion, imaging, laboratory services and medical offices.”
  • and
    • “Becker’s has reported on more than 30 ASC closures in 2026 as outpatient surgery facilities cite consolidation, efficiency and shifting care sites. 
    • “[The article offers] a look inside five more recent ASC closures as the industry battles reimbursement declines, staffing shortages and shifting market power dynamics. 
  • Healthcare IT News tells us,
    • “Telemedicine has made it routine for clinicians and patients to connect by video. But for health systems, establishing that connection is no longer the hardest part of virtual care. The bigger challenge is making sure the right patient gets a virtual visit in the first place – and that everything that should happen afterward actually happens.
    • “For telehealth veteran Dr. Joe Kvedar, professor of dermatology at Harvard Medical School and senior clinical advisor and two-time board chair at the American Telemedicine Association, the operational issues confronting provider organizations now come down largely to two areas: EHR integration and patient triage.
    • “Many health systems have made substantial progress integrating telemedicine into the electronic health record, says Kvedar, but determining which patients and conditions truly belong in a virtual encounter remains more difficult.”
  • and
    • “For decades, hospitals have largely treated discharge as the end of the acute care journey. Once patients left the building with a folder of instructions and follow-up recommendations, responsibility shifted largely to them and their families.
    • “But that approach is becoming increasingly difficult to sustain as hospitals assume greater accountability for patient outcomes long after patients leave inpatient care.
    • “New payment models, continued pressure to reduce avoidable readmissions and growing expectations for coordinated care are forcing provider organizations to rethink what happens after discharge.
    • “For Dimer Health CEO Caroline Hodge, PA-C, the answer is straightforward: Transitional care must become an active, technology-enabled extension of the hospital, rather than a passive handoff.
    • “The first 90 days aren’t an afterthought anymore,” Hodge said. “They’re where the outcome, and the economics, actually get decided.”
  • MedTech Dive informs us,
    • “MiniMed has begun shipping its new insulin pump in the U.S. with the Abbott-made Instinct sensor, the Medtronic spinout said last week. The sensor can be used for up to 15 days before it needs to be changed.
    • “The company said the rollout of its new MiniMed Flex delivery device with Instinct combines the smallest and only app-controlled insulin pump with the world’s smallest sensor.
    • “MiniMed is supporting the launch with its first major marketing campaign for the insulin pump. The campaign focuses on MiniMed Flex’s “discreet” design, app control and automation.”
  • Beckers Hospital Review notes,
    • “Mark Cuban Cost Plus Drug Co. has partnered with RxSaveCard and nonprofit Golden Thread to streamline sourcing and reduce costs of pediatric cancer clinical trial medications. 
    • “Once enrolled in a study, patients will sign up for RxSaveCard and receive trial medications delivered to their homes through Cost Plus Drugs, according to a news release shared with Becker’s.
    • “No study should stall over the price of a generic drug and no family should wait on one,” Alan Bowe, chief commercial officer at Cost Plus Drugs, said in the release. “We’re proud to work with Golden Thread and RxSaveCard to make trial medications affordable and deliver them directly to patients’ doors and we hope every trial that needs this model uses it.”

Friday report

David Ermer–Agentic & Generative AI, CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Beckers Hospital Review reports,
    • “Mark Cruz was named the director of HHS’ Indian Health Service, according to an Aug. 21 news release.
    • “The Senate confirmed Mr. Cruz on Aug. 7 following President Donald Trump’s June 1 nomination. President Trump has since signed the commission granting him the role.
    • “Mr. Cruz, a citizen of the Klamath Tribes, will have a four-year term. The position had been empty since January 2025, and Mr. Cruz is the agency’s 12th Senate-confirmed director.
    • “IHS, the country’s 18th largest public health system, provides healthcare services to roughly 2.8 million American Indians and Alaska Natives across nearly 600 federally run hospitals and clinics, tribal health programs and urban Indian organizations.”
  • STAT News relates,
    • “President Trump and health secretary Robert F. Kennedy Jr. are pressing ahead with efforts to change how kids in the U.S. get their shots. 
    • “The latest move, a request for information posted Friday, offers more clues to Kennedy and Trump’s vision for vaccine policy, and shows that pursuing changes is a priority. It does not make any changes itself, but it asks for feedback on a wide variety of ideas. It gives the public 30 days to comment.
    • “Among the questions it asks the public to consider is whether there should be new categories to the vaccines framework, which currently includes universal recommendations, recommendations for certain risk-based groups, and recommendations based on shared clinical decision-making.” * * *
    • “On Friday, the White House unveiled a new website celebrating 555 days of the Make America Healthy Again movement (Friday marks 555 days since Kennedy was confirmed as HHS secretary). Among the list of achievements is “delivering gold standard childhood vaccine recommendations,” touting the executive order for solving a purported problem: that the U.S. recommends more vaccines than other peer nation.”
       
  • Per a Department of Health and Human Services news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today announced the development of the first-ever National Autism Missing and Endangered Person Alert initiative. Led by HHS in partnership with the U.S. Department of Justice (DOJ) and the Federal Emergency Management Agency (FEMA) under the Department of Homeland Security (DHS), the initiative will work to strengthen coordination among emergency management agencies, law enforcement, first responders, and community partners nationwide to improve preparedness and response when autistic individuals are reported missing. It will also establish a national framework of best practices to address the leading causes of preventable injury and death among autistic individuals, which include accidental drowning linked to wandering and elopement.
    • “When an autistic child or adult goes missing, every minute matters,” said Secretary Kennedy. “President Trump has made improving the lives of Americans with autism and their families a priority. We are bringing federal, state, and local partners together to improve prevention, speed the response, and help bring autistic children and adults home safely.”
  • McKinsey & Company interviews Seema Verma about advancing American healthcare.
    • “A former CMS administrator and current Oracle Health and Life Sciences executive discusses leadership, public–private collaboration, and the promise of AI and value-based care.”
  • MedTech Dive tells us,
    • “Siemens Healthineers and Philips North America are among a group of companies and universities that will receive funding from the Advanced Research Projects Agency for Health to develop autonomous endovascular robotics to treat stroke patients.
    • “The federal awards, totaling up to $175.3 million over five years, are intended to further research on technology to bring faster stroke treatment to more people. Siemens’ work would enable robots to perform long-distance treatment of acute ischemic stroke through mechanical thrombectomy without direct human input, the company said Thursday.
    • “Stryker, which established a strategic partnership with Siemens Healthineers last year to develop robotic neurovascular interventions, is a subrecipient in the project, Siemens Healthineers said. Others receiving ARPA-H funds for robotic stroke treatment include MIT spinout Magnendo and the University of California, San Diego.”

From the U.S. Office of Personnel Management front,

  • OPM Director Scott Kupor added another post (Substack link) to his Secrets of OPM blog today. This post concerns artificial intelligence.
    • “AI adoption is measurable with three metrics — and the numbers tell you what to do next.
    • “Nobody at your agency has a Microsoft Word adoption strategy. Word is simply how documents get written, the way email is how messages move. My theory is that AI becomes part of the operating system of how work gets done. Broadly used, barely remarked on.
    • “So, how do we get there? We need metrics to understand where we stand and guide our next steps. Our signals come from three questions. Do people use the tools? Do they like them — do they feel the tools help them do the work? Is the business better? Use, sentiment, impact. That is the whole framework.”
  • Federal News Network asks “Are you getting the most out of your TSP? Probably not — here’s how to change that.”
    • Being aware of a few lesser-known tricks and pitfalls can help federal employees get the most out of their TSP, and subsequently, their retirement.

From the Food and Drug Administration front

  • BioSpace reports,
    • “Three fatalities occurring recently in China clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients.
    • “After three patient deaths were reported in separate gene therapy clinical trials in China, two members of the House of Representatives are asking the FDA to implement specific measures to lower patient risk in the U.S.
    • “Reps. John Moolenaar (R-MI) and Ben Cline (R-VA) have reportedly penned a letter to Acting FDA Commissioner Kyle Diamantas, writing that “accepting Chinese clinical data poses real risks for patients,” according to Endpoints News.
    • “The two lawmakers are asking the agency to reject clinical data from China unless the trial site has recently undergone an FDA audit, and to also conduct a wide-ranging review of products that have received U.S. approval based on clinical results from China, according to the letter obtained by Endpoints.”
  • Newsweek relates,
    • “The Food and Drug Administration (FDA) has given a recall of popular Whole Foods dips its highest risk classification, warning that consuming the items could cause “serious adverse health consequences or death.”
    • “The recall, which Whole Foods issued earlier this month, involves products containing jalapeños—such as guacamole and pico de gallo—sourced from Coast Citrus Distributors, a wholesale fresh produce supplier operating across the U.S. and Mexico. The jalapeños are believed to be potentially contaminated with salmonella bacteria.
    • “After the first few cases of salmonella were reported across the country over the summer, federal investigators identified a grower in Sinaloa, Mexico, as the potential source of contamination.” 
  • The American Hospital Association tells us,
    • “The Food and Drug Administration has identified a Class I recall of certain Medline convenience kits containing B. Braun components that have Huons Bupivacaine Hydrochloride in Dextrose Injection, which has also been recalled. As of April 24, B. Braun reported 35 serious injuries and no deaths associated with the issue. Medline had not reported any additional serious injuries or deaths associated with the issue as of June 19, the FDA said.”
  • Cardiovascular Business adds,
    • “The U.S. Food and Drug Administration (FDA) has confirmed a new recall for Boston Scientific’s Enroute Transcarotid Neuroprotection System and Enroute Transcarotid Neuroprotection System Plus. The recall was put in place due to a risk of arterial sheath tip separation or partial tip separation during use. One serious injury has been linked to this issue.
    • “The FDA first warned the public about these risks in July as part of its Early Alert pilot program. The issue was still under investigation at that time. Now, the agency has reached its conclusion that this is a Class I recall, which means these devices are associated with a risk of “serious adverse health consequences or death.”  
    • “This recall includes more than 115,000 units of the Enroute Transcarotid Neuroprotection System and nearly 50,000 units of the Enroute Transcarotid Neuroprotection System Plus. Customers with any of these devices on hand should stop using them right away and start the process of returning them to Boston Scientific. If customers know of any Enroute systems forwarded from one facility to the next, they should communicate with that facility about this concern.
    • “Click here for more information from the FDA, including specific lot numbers.”
  • Newswise informs us,
    • “The U.S. Food and Drug Administration (FDA) has cleared for marketing an innovative blood test with underlying technology invented at Washington University School of Medicine in St. Louis for the early diagnosis of Alzheimer’s disease. The test, known as PrecivityAD2, was developed and validated by C2N Diagnostics, a WashU startup company.
    • “PrecivityAD2 is a blood-based diagnostic test cleared by the FDA to aid in identifying the presence of amyloid plaques in the brain associated with Alzheimer’s disease in certain patients. Unlike some other FDA-cleared blood-based tests that use immunoassay methods to analyze biomarkers associated with Alzheimer’s, PrecivityAD2 uses high-resolution mass spectrometry to provide quantitative measurements of the biomarkers.
    • “The availability of blood-based biomarker testing may help clinicians evaluate patients for Alzheimer’s disease using a less invasive approach than cerebrospinal fluid testing. Biomarker information may also help inform appropriate clinical management when interpreted together with a patient’s clinical history and other diagnostic information.”

From the public health and medical / Rx research

  • The Centers for Disease Control and Prevention announced today
    • “As of August 21, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “National and regional COVID-19 activity is increasing.
    • “RSV activity is very low in most areas of the country.
    • “Seasonal influenza activity is low.
    • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally. Parainfluenza virus (PIV) is elevated in some regions.”
  • CNN adds,
    • Are you coughing, hacking or feeling feverish? It may not be just a summer cold; you might want to consider taking a Covid test.
    • Although the autumn respiratory illness season hasn’t kicked off, and flu and RSV activity remain low, there’s a growing summer wave of Covid-19.
    • Case numbers aren’t especially high, and the United States isn’t recording many hospitalizations or deaths. But data from the US Centers for Disease Control and Prevention puts the test positivity rate for the week ending August 8 above 3% for the first time since March, with numbers climbing in every state.
    • “August is solidly Covid season,” said Dr. Caitlin Rivers, an expert in outbreak science and senior scholar at the Johns Hopkins Center for Health and Security. “Right now, the South and the West are sort of the leading edge of this Covid season. In the past, it almost always starts in Florida, Texas and Georgia, which is exactly what we’re seeing this year.”
  • The University of Minnesota CIDRAP reports,
    • “The rapidly rising US measles outbreak grew to 2,777 cases today as the Centers for Disease Control and Prevention (CDC) confirmed 211 new infections in its weekly update.
    • “The increase is more than double that seen last week, when the agency added 101 cases to the total, after adding 94 the week before. Most of this week’s cases are in Pennsylvania and Ohio. 
    • “The CDC noted 36 outbreaks, which might be an anomaly, as a week ago the agency had logged 38 for the year. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level a month ago. 
    • “All but 16 of this year’s cases have been locally acquired, with the rest tied to international travel. Cases have been confirmed in 45 states plus New York City and Washington, DC.
    • “Of the 2026 cases, 19% involve children age 5 and under, and 66% involve kids and teens. Seven percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 94% are unvaccinated or have an unknown vaccine status. 
    • “No measles deaths have been reported this year. Last year, three people, including two children, died of measles, one of the most transmissible diseases known.”
  • The American Hospital Association News lets us know,
    • “There have been 15,716 confirmed cases of cyclosporiasis across 47 states, Washington, D.C., and Puerto Rico since May 1, the Centers for Disease Control and Prevention data reported Aug. 18. There have been 828 hospitalizations. The agency said there are at least 11,841 additional cases that require further investigation. Two people have died from the multistate cyclosporiasis outbreak linked to iceberg lettuce.” 
  • USA Today adds,
    • “While these numbers show that confirmed cases themselves are still rising, the overall trend is on a downward swing; previous weeks regularly saw increase that numbered into the 2,000 and 3,000 range.”
  • The Washington Post provides more context,
    • “Federal officials said Thursday that recalled Taylor Farms lettuce linked to a large cyclospora outbreak may have been distributed to nine additional jurisdictions, expanding the potential reach of contaminated products.
    • “The best-by dates for these recalled products have passed, officials said, and they should no longer be available for sale in stores or restaurants. Consumers who previously bought or received food items with the recalled iceberg lettuce should carefully clean and sanitize any surfaces or containers that it may have touched.
    • “The expanded distribution information provides a fuller picture of where the recalled lettuce may have traveled than was known when Taylor Farms de Mexico announced a voluntary recall July 17. The company removed iceberg lettuce sourced from central Mexico from the U.S. market after it was linked to the outbreak and said it had been distributed to 27 states.”
  • The Wall Street Journal points out,
    • “An outbreak of E. coli and salmonella linked to alfalfa sprouts has sickened dozens of people across 15 states, public-health officials said. 
    • “The Centers for Disease Control and Prevention on Friday urged consumers not to eat alfalfa sprouts grown by Everything Sprouts and sold under the Calco and Everything Sprouts brands. Fifty-five people have been infected with E. coli or salmonella in connection with the outbreak, the health agency said, including two people who contracted both pathogens. 
    • “No one has died in the outbreak, the CDC said. Four people have been hospitalized.” 
  • Beckers Clinical Leadership tells us,
    • “The American College of Obstetricians and Gynecologists has released updated guidelines supporting fallopian tube removal to reduce ovarian cancer risk. 
    • “The updated guidance was published Aug. 20 in Obstetrics & Gynecology.  The move comes after a study found fallopian tube removal can reduce patients’ ovarian cancer risk by almost 80%.
    • “Common procedures inside the abdomen or pelvis, including hysterectomy, tubal procedures for permanent contraception and non-gynecologic surgeries, offer opportunities for patients to reduce their risk of ovarian cancer through salpingectomy,” ACOG said in an Aug. 20 news release.
    • “Read the full updated guidance here.”
  • Health Day adds,
    • “Could a diet rich in antioxidants help women lower their risk of cervical cancer?
    • “A new study suggests these compounds may play a role in preventing the disease, the fifth-most commonly diagnosed cancer in women globally.
    • “A team led by Maozhu Lang of the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing analyzed data from more than 1,000 U.S. women who took part in national health and nutrition surveys between 2003 and 2018. Some had a history of cervical cancer. Others did not.
    • “Researchers looked at their intake of vitamins A, C and E, zinc, selenium and carotenoids — antioxidants found in foods such as fruits, vegetables and whole grains.
    • “The result: Those with the highest antioxidant intake had nearly 56% lower prevalence of cervical cancer compared to those with the lowest intake.”
  • The University of Minnesota informs us,
    • “People vaccinated against the human papillomavirus (HPV) were much less likely to develop cancers of the head and neck, according to a study published this week in the International Journal of Infectious Diseases. 
    • “The study confirms earlier research finding a vaccine-related decrease in head and neck cancers.
    • “The new study analyzed 1.4 million medical records from 66 US healthcare organizations. Half of the research subjects were vaccinated against HPV from ages 9 to 45. The other half were vaccinated against other diseases but not HPV. Study participants were vaccinated from January 2011 to June 2024. 
    • “People vaccinated from age 9 to 26 years—the age range recommended by the American Academy of Pediatrics—were 68% less likely to be diagnosed as having head or neck cancer, according to the study.
    • “There was no statistically significant reduction in head and neck cancers in people vaccinated from age 27 to 45, most likely because these people had been exposed to HPV before being immunized, said Ching-Nung Wu, MD, PhD, first author of the paper and an otolaryngologist at Kaohsiung Chang Gung Memorial Hospital in Taiwan.”
  • The New York Times notes,
    • “There’s about a two- to threefold increased risk of developing dementia if you have epilepsy,” said Dr. Alice Lam, an associate professor of neurology at Harvard Medical School. And “if you have dementia, you have, on average, a two- to threefold increased risk of developing seizures.”
    • “Links between epilepsy and dementia — conditions that affect millions and are more prevalent in older age — are increasingly crucial to recognize as people live longer, experts say.
    • “It’s a super important, super common thing around the world, and yet it really, really does not get attention,” said Dr. Arjune Sen, a professor of global epilepsy at the University of Oxford.”

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

  • Beckers Hospital Review reports,
    • “Rochester, Minn.-based Mayo Clinic recorded operating income of $501 million (8.6% operating margin) in the second quarter of 2026, up from $394 million (7.4% margin) during the same period last year, according to its Aug. 21 financial report. 
  • and
    • ‘BradenHealth has acquired the former Jellico (Tenn.) Hospital, with plans to reopen it as a full-service hospital.
    • “The purchase from the City of Jellico is a minimum $14 million investment and is expected to create about 120 jobs, according to an Aug. 21 BradenHealth news release shared with Becker’s.
    • “Jellico Hospital’s closure left a painful gap in access for families who already face significant barriers to care,” Founder and CEO Beau Braden, DO, said in the release. “We did not acquire this facility to simply reopen doors; we acquired it to rebuild a reliable, high-quality healthcare presence that the people of this region can count on.”
  • Business Insider points out,
    • Disney is joining other big-name companies in curbing employee benefits, a move that comes as healthcare costs rise.
    • Starting next year, the entertainment giant will no longer offer medical insurance plans to US employees’ spouses if their spouses have jobs that provide such coverage, a Disney spokesperson confirmed to Business Insider. Employees’ other dependents won’t be impacted.
    • “Like a growing number of large employers, we’re making measured adjustments to our employee benefits in response to rising healthcare costs nationwide,” the company said in a statement.
  • Fierce Pharma relates,
    • “After a one-week hiccup, Novo Nordisk’s Wegovy pill regained its momentum last week with its largest prescription rate since it was launched in January. There were more than 176,000 prescriptions for the pill in the period, according to data gathered by IQVIA and cited in a note by Citi. 
    • “The oral treatment now accounts for 35% of total Wegovy prescriptions, which is up from 33% the previous week, analysts from Citi said in their weekly update to investors.
    • “Meanwhile, Eli Lilly’s oral GLP-1 Foundayo, which had been on a steady five-week climb, backtracked, with a drop-off from 38,928 prescriptions in the prior period to 36,620 in the latest week.
    • “The movements for the two oral treatments contributed to overall market share adjustments for the companies’ diabetes and obesity medicines. While Lilly made a 0.1% gain to 56.7%, Novo increased its market share by 0.3% to 37.1%.” 
  • Beckers Hospital Review notes,
    • “Health systems have spent two years debating which AI tools to buy. The executives running them are starting to question how often they need to revisit that decision.
    • “Richard Mulry, president and CEO of Northwell Holdings in New Hyde Park, N.Y., sees the cycle speeding up as the cost structure around AI changes.
    • “The most dangerous trend in healthcare right now is borrowed conviction: letting someone else’s roadmap, or someone else’s press release, stand in for your own operating strategy,” Mr. Mulry said. “AI has created a kind of gravitational pull where the fear of being late is doing more to pressure capital allocation than the actual problems in front of us.”
    • “The pressure produces two failure modes that look like opposites. One is premature commitment — investing early in solutions that will eventually be absorbed into core platforms, leaving organizations managing technical debt with no lasting strategic value. The other is waiting for platform vendors to deliver while nothing changes in the workforce, the workflows, or the cost structure.
    • “Participation driven by optics and paralysis look like opposites, but we’ve come to see them as the same failure: outsourcing judgment to the market’s clock instead of your own operating priorities,” Mr. Mulry said.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Mental health care, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Hill reports,
    • “Lawmakers are sounding the alarm over the nation’s $40 trillion debt, lamenting Congress’s inability to meaningfully confront a problem that has grown increasingly difficult to ignore.
    • “Both parties have spent years trying to tackle the rising debt. Republicans have frequently pointed to federal spending and entitlement programs as the main drivers, while Democrats have emphasized the need for higher taxes on wealthy Americans and corporations alongside spending reforms.
    • “But efforts to reach a broader deal have repeatedly stalled as both parties have balked at the politically painful trade-offs needed to put the nation on a more sustainable fiscal path.” 
  • Modern Healthcare relates,
    • “A Senate bill [S. 3097 – Health Information Privacy Reform Act] would create medical privacy protections for consumer health products such as wearables and wellness apps.
    • “The legislation unanimously passed the Senate health committee last month and a similar bill is pending in the House.
    • “Stronger privacy rules could hamper some tech companies while benefiting others as well as providers eager to tap into new technology.”
  • Per a CMS news release,
    • “The Trump Administration announced an additional $4.2 million, made possible through the federal Rural Health Transformation Program (RHTP), is being put to work in West Virginia to expand patients’ transportation options and remove service barriers.
    • “By injecting millions into the Rural Health Link initiative, the Administration is upending the status quo that has limited transportation options for residents in need of critical healthcare services and delivering on its commitment to West Virginians who deserve the best access to care no matter their zip code. These funds will help increase medical transportation capacity, service availability, and improve geographic coverage for patients across the Mountain State.” 

From the U.S. Office of Personnel Management front,

  • Today’s Washington Post included an oped written by OPM Director Scott Kupor about his agency’s efforts to improve the merit system.
    • “At the Office of Personnel Management — Washington’s chief HR agency — my team has spent the past 20 months reforming this system. Our goal is simple and uncontroversial: Merit matters, not how long employees have been in a role or what college degree they earned, both in hiring and in day-to-day performance. That means accountability for employees who can’t deliver and distinction for those who knock the cover off the ball.”
  • Govexec adds,
    • “An agency spokeswoman said that a four-person communications team — all under the age of 30 — is spearheading the effort to make OPM’s social media more appealing to younger potential hires.”
  • Tammy Flanagan writing in Govexec, lets us know,
    • “Retiring from federal service is a major milestone, of course, but it does not end the need to understand how federal benefits work. In the years after retirement, life events and new opportunities can raise important questions about insurance, survivor benefits, beneficiary designations and the effect of returning to government employment.
    • “Today I will highlight several post-retirement issues that federal employees may want to plan for in advance. This is not an all-inclusive list, but it’s a list that will hopefully remind you that it is important to review your benefits and be sure to understand how they can change as life goes on.” * * *
    • “Health benefits can also change after retirement, not only the premiums and the benefits, but your needs may change over time. Outside of open season, FEHB changes generally must be tied to a Qualifying Life Event (QLE), such as marriage, divorce, death of a family member, or a move out of a plan’s service area, and many changes must be requested within 60 days of the event.
    • “Annuitants should confirm the effective date with OPM because the timing can depend on the type of change. For example, some enrollment decreases may be made at any time and are commonly effective at the beginning of the month after OPM receives the election, while other changes follow the qualifying life event rules.
    • “There is a little-known option to change insurance just because you have reached age 65, it is QLE 2L. This is your “ace in the hole” that you can only use once in your lifetime to change plans outside of open season.
    • “This is generally used to change plans when enrolling in Medicare after retirement, but if not used at age 65, it can be used later – but only once!”

From the Food and Drug Administration front,

  • CBS News reports,
    • “A New York-based consumer healthcare company is recalling nearly 40,000 bottles of eye drops over concerns about the product’s sterility. 
    • “Prestige Consumer Healthcare initiated the recall on July 29 due to “lack of assurance of sterility,” according to a U.S. Food and Drug Administration notice.
    • “The recall is due to potential contamination,” the notice says.
    • “The recall affects 15mL bottles of Clear Eyes’ Maximum Itchy Eye Relief, which mitigates itchiness, redness and other eye irritations, according to the product description. The eye drops were distributed nationwide.”
  • Fierce Pharma relates,
    • “If at first you don’t succeed in gene therapy, then try, try again. That’s the lesson Ultragenyx likely took home this week as it pocketed its first FDA nod in the class just over a year after a separate program stalled on manufacturing grounds. 
    • “Late Wednesday, the FDA gave an accelerated go-ahead to pariglasgene brecaparvovec-opnr, Ultragenyx’s AAV gene therapy for the rare genetic disorder glycogen storage disease type Ia (GSDIa), which will now head to market with the brand name Genglycos. 
    • “The accelerated approval specifically covers the gene therapy—previously coded as DTX401—in adults and kids over the age of 8 years with GSDIa, an ultrarare genetic disorder driven by a deficiency of the enzyme G6PC, which is needed to release glucose from the liver into the bloodstream. The liver is less capable of controlling glucose levels in these patients, leading to potentially life-threatening hypoglycemia episodes and other complications. 
    • “By Ultragenyx’s reckoning, there are between 1,500 and 2,500 people living with GSDIa in the U.S. out of an estimated global patient population of 6,000 to 8,000 “within commercially accessible geographies,” the company said in an Aug. 19 release.” 
  • HCPLive tells us,
    • “The U.S. Food and Drug Administration (FDA) has approved Glenmark Pharmaceuticals’ fluticasone propionate nasal spray, USP, 0.05 mg (50 mcg)/spray, a generic version of Haleon’s Flonase Nasal Spray indicated for nasal symptoms of allergic rhinitis, the company announced on August 20, 2026.¹
    • “The approval of fluticasone propionate nasal spray, USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area,” said Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals. “We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.” * * *
    • “FDA approval was secured through the bioequivalence pathway, so no independent clinical efficacy or safety program accompanied authorization beyond equivalence to the reference product.” * * *
    • “Distribution will be handled by Glenmark Pharmaceuticals Inc., USA, while pricing and launch timing were not disclosed.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A growing number of Americans say their cannabis use is problematic, according to a large new study released Wednesday.
    • “The study, based on nationally representative data of U.S. adults, found that more than 9 percent of the men — or almost 1 in 10 — reported symptoms of cannabis use disorder in 2024, up from about 7 percent in 2021. The prevalence of cannabis use disorder also rose among women, increasing to nearly 6 percent in 2024, up from about 5 percent in 2021. Symptoms of the disorder include not being able to cut back or quit, or continuing to use the drug despite it leading to interpersonal problems.
    • “The notion that cannabis is not addictive may basically be incorrect,” said Dr. Nora D. Volkow, the director of the National Institute on Drug Abuse and the paper’s senior author.”
  • and
    • “There is no one-size-fits-all approach to managing treatment-resistant depression.
    • “At the UC Davis clinic, if patients don’t improve after trying two antidepressants in succession and undergoing psychotherapy, they may be prescribed a low dose of an additional drug such as an atypical antipsychotic or lithium, Dr. Debra Kahn, director of the Advanced Psychiatric Therapeutics Clinic at UC Davis Health said. Clinicians will ensure that medical problems that could be contributing to symptoms are addressed, too.
    • “One additional therapy that has been shown to help people with treatment-resistant depression is transcranial magnetic stimulation, or T.M.S., which was cleared by the U.S. Food and Drug Administration to treat depression in 2008, Dr. Kahn said. It uses magnetic pulses to stimulate parts of the brain to release mood-boosting chemicals including norepinephrine, dopamine and serotonin, she said.
    • “T.M.S. is tolerated well and has no long-term serious side effects, Dr. Kahn said. * * *
    • “Ketamine, an anesthetic commonly used in surgery, is increasingly used to address treatment-resistant depression. In 2019, the FDA approved Spravato, an intranasal spray containing esketamine. In a 2019 trial, 52.5 percent of patients with treatment-resistant depression who took esketamine with an antidepressant for 28 days experienced a significant resolution of their symptoms compared with about 31 percent of people who took an antidepressant with a placebo.” * * *
    • [T]here is unlikely to be one “magic pill” that cures treatment-resistant depression, Dr. Kahn said. People may benefit from a combination of approaches, and they may also need to combine treatments with lifestyle changes.”
  • MedPage Today tells us,
    • “The relationship between physical activity and dementia risk may depend on whether the activity is recreational exercise or job-related labor, a study of more than 4.2 million people suggested.
    • “High physical activity levels were linked to a 20% lower risk of all-cause dementia (relative risk [RR] 0.80, 95% CI 0.75-0.86) over 10 years compared with the lowest level of physical activity, reported Natan Feter, PhD, of the University of Southern California in Los Angeles, and colleagues in a systematic review and meta-analysis.
    • “Leisure-time activities like walking, running, swimming, cycling, or playing sports followed a similar pattern and were tied to lower dementia risk (RR 0.76, 95% CI 0.65-0.88), the researchers wrote in Lancet Public Healthopens in a new tab or window. Household physical activity also appeared beneficial, but evidence was from a single study.”
  • and
    • “A recent report advocated against using BMI as a standalone tool in measuring health risk.
    • “Longitudinal data suggested that high waist circumference was associated with elevated mortality risks, while high BMI was tied to lower mortality risks, among older adults.
    • “Underweight status was associated with a higher mortality risk compared with normal weight in both men and women, regardless of waist circumference.”
  • The American Medical Association lets us know “what doctors want patients to know about mosquito bites.
    • “Mosquito bites spark immune reactions from itchy bumps to Skeeter syndrome and severe illnesses, but prevention and knowing warning signs can reduce risks.”
  • Cardiovascular Business informs us
    • “Transcatheter aortic valve replacement (TAVR) continues to gain momentum as a go-to treatment option for severe, symptomatic aortic stenosis. However, surgical aortic valve replacement (SAVR) remains a significantly safer option for patients 60 years old and younger, researchers confirmed in a new study published in JTCVS Open.[1]
    • “Current guidelines recommend SAVR for patients younger than 65 years, yet an increasing number of younger patients are undergoing TAVR with uncertain long-term results,” wrote first author Jessan A. Jishu, MD, with the Tulane University School of Medicine, and colleagues. “Given this lack of clarity and growing real-world adoption of TAVR among younger individuals, this study uses a large-scale database representative of practices in the United States to confirm the findings from these previous studies by assessing short- and long-term outcomes of SAVR versus TAVR in patients younger than 60 years, a population in whom long-term durability and reintervention risk are of particular concern.”
    • “Jishu et al. explored the TriNetX database, exploring real-world data from nearly 10,000 patients who underwent TAVR or SAVR from 2006 to 2025. Approximately 80% of patients were treated with SAVR, but TAVR grew more common from 2020 to the end of the study.”
  • and
    • “A Cedars-Sinai Health Sciences University-led study has identified molecular changes that appear to trigger atherosclerosis years before inflammation, sharing their findings in European Heart Journal.
    • “The group believes this could a key discovery in the development of next-generation early prevention therapies. 
    • “The study’s authors found previously unrecognized molecular pathways and a possible master regulator protein called MLXIPL that could become future targets for clinicians working to stop plaque from ever developing.
    • “We analyzed proteins and gene activity in coronary artery tissue from young adults who died of trauma and had no known coronary artery disease, and we found that more than half already had preclinical atherosclerosis,” first author Sarah Parker, PhD, an associate professor of cardiology and biomedical sciences and co-director of the proteomics and metabolomics core at Cedars-Sinai Health Sciences University, said in a statement. “This suggests that changes in cellular metabolism and communication begin before the inflammation long considered a hallmark of the disease.”
    • “Parker said this research provides a direct picture of what is happening inside the artery wall and may explain why some people are more vulnerable to heart disease than others.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of ifezuntrigene inilparvovec (uniQure N.V.) for Huntington’s disease. This therapy is also known as AMT-130.
    • “The assessment will be publicly discussed during a meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in March 2027, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
    • “Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including relevant patient groups, and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.”  

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

  • The Wall Street Journal reports,
    • “Surging healthcare costs are walloping U.S. workers, and they will only worsen next year. For 2027, employers may be facing the biggest health-insurance increase in at least two decades.
    • “Americans with workplace coverage are expected to spend an average $5,297 this year on healthcare, $388 more than 2025, according to a new estimate from benefits-consulting firm Aon. The spending represents a combination of payroll deductions for premiums and out-of-pocket charges like deductibles and copays.
    • “The burden is likely to grow significantly next year, when U.S. employers expect their healthcare costs to go up by 11.1%, according to a new survey from WTW, another big benefits consultant—the steepest rise in more than 20 years.
    • “That would represent the fifth year of escalating increases, according to WTW. “Employers are telling us that this is utterly unsustainable,” said Jeff Levin-Scherz, population-health leader at WTW. Expensive cancer treatments and wide adoption of weight-loss drugs are among the factors pushing up spending.”
  • and
    • “Costco sells its dedicated members everything from travel packages to gasoline. Now the retail giant is gearing up to enter a huge new market: Medicare. 
    • “The warehouse chain plans a limited rollout of Costco-branded Medicare plans, working with SCAN Group, a nonprofit insurer. Nationally, Medicare is a more than $600 billion business for insurers, but the two companies said they would start by selling their jointly named Medicare Advantage products in two states, and a Medicare supplement in a third. 
    • “SCAN and Costco executives said the three target markets include around five million Medicare enrollees but declined to disclose exact locations or timing, citing regulatory limits on disclosure pending approval by the Medicare agency.
    • “SCAN is based in Long Beach, Calif., and Southern California is a core market for the nonprofit, which focuses on Medicare and has about 460,000 members. SCAN also offers Medicare Advantage plans in Arizona, Nevada, New Mexico, Texas and Washington state.”
  • Modern Healthcare adds,
    • “Centene is scaling back its Medicare Advantage presence next year as the health insurance company looks to cut costs. 
    • “The insurer plans to completely withdraw from Oklahoma, Tennessee and Hawaii, according to a notice the company distributed to third-party marketing organizations last week.
    • “Centene is also preparing to exit at least 158 counties and cancel 133 Medicare Advantage plans, according to a Modern Healthcare analysis. Modern Healthcare compared the company’s list of available policies for 2027 to the Centers for Medicare and Medicaid Services enrollment file for this month.
    • “The cancellations would drive about a third of Centene’s Medicare Advantage membership, or more than 340,300 enrollees, to shop for new coverage, according to the Modern Healthcare analysis. Members may have alternative Centene plans from which to choose.” 
       
  • The Health Care Cost Institute released a report about the “Effects of vertical integration on providers’ billing and practice patterns in Medicare (2018-2022)”
  • Fierce Healthcare notes,
    • “The blockbuster success of GLP-1 weight loss drugs has caused major ripple effects across healthcare and pharma, representing a significant growth engine for drugmakers but a cost challenge for payers.
    • “GLP-1s are also potentially disrupting a healthcare system built around treating obesity-related complications, forcing providers, insurers and investors to rethink where future revenue and growth will come from, according to a new report from Wells Fargo.
    • “For decades, the healthcare industry has built service lines, reimbursement models and care pathways around the downstream consequences of obesity. Diabetes clinics, cardiology service lines, sleep medicine, orthopedics, bariatric surgery, pharmacy and chronic disease management have all grown inside a system where obesity was widespread, persistent and often untreated.
    • “GLP-1s may be starting to upend that model as the growing use of obesity drugs begins to influence utilization patterns, hospital economics, pharmaceutical R&D and long-term healthcare spending, wrote Robin Wenzel, head of Wells Fargo Industry Insights and John Teasley, market executive, Wells Fargo Healthcare Banking, in the report.
    • “The latest data from the Centers for Disease Control and Prevention and the National Center for Health Statistics indicates that 40.3% of U.S. adults have obesity, and 9.4%, roughly one in ten, have severe obesity. That makes obesity not an outlier, but a baseline condition around which much of U.S. healthcare now operates, the report authors assert.
    • “GLP-1 drugs for weight management move the management of obesity upstream, to prevention in the context of a system designed around late-stage disease. That puts traditional obesity-related service lines, and healthcare’s obesity revenue engine, under pressure, according to the report.”
  • Beckers Hospital Review points out how 14 large health systems performed financially during the three months ended June 30, and tells us,
    • “New CMS data shows emergency department visit times climbed in the vast majority of states compared with the same period last year, though wide variation persists across the country.
    • “The agency’s “Timely and Effective Care” dataset covers children and adults treated at hospitals paid under the Inpatient Prospective Payment System or Outpatient Prospective Payment System, as well as those that voluntarily report data on relevant measures. Data was collected in the 12-month period ending Sept. 30, 2025. Learn more about the methodology here.
    • :Nationwide, the median time patients spent in the ED was 162 minutes for the 12-month period ending September 2025, stable from the same period a year prior, according to CMS data.:
  • Healthcare Dive notes,
    • “Name: Dr. Shantanu Nundy
    • “Previous title: Executive vice president of care delivery and chief health officer, Accolade
    • “New title: Chief medical officer, Humana
    • “Nundy will become Humana’s new CMO effective Aug. 31, the Kentucky-based insurer announced Thursday.
    • “He’s replacing Kate Goodrich, who served as CMO from 2022 to October 2025, when she left for a role in the health services division of Humana’s rival insurer UnitedHealth. The CMO post has sat empty since.
    • “As CMO, Nundy will help design Humana’s products, platforms and use of artificial intelligence with a clinical eye, according to the release.”
  • and
    • “Name: Arun Kumar Bhaskara-Baba
    • “Previous title: Chief information officer, Honeywell Aerospace and Defense
    • “New title: Chief information officer, Mayo Clinic
    • “Bhaskara-Baba joined Mayo Clinic as CIO in May, the Minnesota-based health system confirmed in a statement. He’s at the helm of Mayo’s information technology systems across its network of 16 hospitals and 45 multispecialty clinics.
    • “Bhaskara-Baba is succeeding Cris Ross, who retired in 2024 after 12 years in the role.
    • “Bhaskara-Baba brings more than 25 years of tech experience to the role. He joins Mayo from Honeywell Aerospace and Defense, where he directed digital strategy and scaled the company’s artificial intelligence capabilities as CIO.”
  • Fierce Healthcare informs us,
    • “Cityblock Health, a company primarily focused on providing care for urban Medicaid and dual-eligible members, plans to acquire Homeward Health to expand deep into rural markets, the company announced Thursday.
    • “Combined, the two companies will serve nearly 250,000 people and are positioned to reach the 120 million people receiving government-funded healthcare in the U.S., Toyin Ajayi, Cityblock Health CEO and co-founder, wrote in a blog post.
    • “Cityblock said it signed a definitive agreement to acquire Homeward in an all-stock transaction. Financial details of the deal were not disclosed.”
  • and
    • “Carrum Health, a company with value-based Centers of Excellence for employers, is teaming up with Included Health, a virtual care and health navigation company working with employers and plans.
    • “Carrum’s Centers of Excellence network for specialty care will be embedded directly into Included Health’s Alternative Health Plan to help connect members to high-quality specialty care with more predictable costs. The partners will connect plan design, navigation and value-based care into one coordinated experience. 
    • “As employers face steep healthcare cost increases, specialty care often drives a lot of healthcare spending. From 2023 to 2025, the U.S. saw the highest three-year stretch of healthcare cost growth in over a decade, according to the Business Group on Health. The Carrum integration will deliver greater cost predictability with bundled rates, outcomes accountability and streamlined contracting.”
  • Healthcare Dive adds,
    • “Healthcare revenue cycle management company R1 has agreed to acquire Humata Health, a company specializing in artificial intelligence-powered prior authorizations.
    • “R1 is banking that Humata’s AI expertise will help it streamline the preapproval process required by insurers for certain medical treatments, and further its goal of automating how healthcare providers get paid for their services.
    • “The acquisition is expected to close in the third quarter this year, after which Humata’s team will start integrating its technology into R1’s revenue cycle platform. An R1 spokesperson declined to share the financial terms of the deal.”

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Electronic health records, FDA, Federal employment benefits, HSA, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC

  • Beckers Hospital Review reports,
    • “The U.S. national debt surpassed $40 trillion for the first time Aug. 19, adding another layer of financial uncertainty for hospitals already navigating elevated borrowing costs and significant federal reimbursement pressures, according to The New York Times. 
    • “The news comes as the federal government is on track to borrow more than $2 trillion this year, with rising interest expenses consuming an increasingly large share of federal spending, according to the report. 
    • “The knock-on effects extend far beyond the federal government’s balance sheet. Higher Treasury yields can increase hospitals’ cost of capital, while the deteriorating fiscal outlook could intensify scrutiny of Medicare, Medicaid and other federal healthcare programs already targeted by the Trump administration for spending reductions.”
  • STAT News relates,
    • “Erica Schwartz, the new director of the Centers for Disease Control and Prevention, told agency staff on Wednesday that she was prepared to disagree with administration leaders and sought to empower others to do the same, according to a recording of the meeting obtained by STAT.
    • “During her first all-hands address on Wednesday, Schwartz identified three priorities: preserving trust through radical transparency and scientific rigor; strengthening the CDC’s ability to respond to disease threats; and building up the agency’s relationship with state and local partners.”
    • “She said she was ready to stand up to health secretary Robert F. Kennedy Jr. if needed to accomplish those goals.
    • :Schwartz said she wasn’t blind to what her predecessor, Susan Monarez, went through — being fired because she wouldn’t agree to follow Kennedy’s orders on vaccine policy — and said she was clear with Kennedy she would act and share information as a physician.
    • “I feel very comfortable and very confident, already having like three or four meetings with them since I started this position, of speaking truth to power,” she said. “I do not feel at all challenged with speaking, you know, what the science tells me and what you all are telling me to represent for the CDC.”
  • Per a CMS news release,
    • “The Trump Administration announced a $90 million investment is being delivered to South Dakota through the federal Rural Health Transformation Program (RHTP) to accelerate digital health modernization, strengthen cybersecurity, and enhance interoperability across rural and underserved communities. This investment will strengthen South Dakota’s health workforce, improve infrastructure, advance technology, and support innovative approaches tailored to the unique healthcare needs across the state.
    • “President Trump understands that every American deserves high-quality healthcare, no matter where they live,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are putting resources directly into rural communities to strengthen the health workforce, modernize infrastructure, expand access, and bring care closer to home. We are giving states the flexibility to build solutions around the people they serve, while demanding accountability for results. That is how we strengthen rural health, improve the lives of patients and families, and Make America Healthy Again.”
  • Beckers Payer Issues tells us,
    • “The average end-of-year balances for health savings accounts reached $5,532 in 2024, up from $4,747 the year prior.
    • “However, that balance fell far below out-of-pocket maximums. In 2025, out-of-pocket maximums for HSA-eligible health plans were $8,300 for individual coverage and $16,600 for families.
    • “The Employee Benefit Research Institute released an issue brief Aug. 13 detailing HSA trends from 2011 through 2024. The institute formed its HSA database more than a decade ago. As of the end of 2024, the database had 15.2 million accounts with total assets of $53.7 billion.
    • “The report outlined the “triple tax advantage” of HSAs: tax-free contributions, tax-free growth and tax-free qualified withdrawals.”
  • Fierce Healthcare points out,
    • “While many individuals believe they have a firm grasp on their Medicare benefits, the reality is far different, according to a new survey.
    • “Insurance agency eHealth conducted a survey of 1,000 Americans and found that 89% of beneficiaries feel “confident” that they understand their Medicare benefits and coverage options. However, just 13% could identify each of the main facets of Medicare, such as the traditional program, Medicare Advantage, Part D and Medicare supplement plans.
    • “In addition, most (88%) said they did not know there is no annual cap on out-of-pocket spending in traditional Medicare, while 82% of those nearing Medicare eligibility said they were not aware that there is a 20% coinsurance for medical services.
    • “Close to half (42%) of beneficiaries were unaware or underestimated that 20% coinsurance, according to the report.”
  • Beckers Behavioral Health informs us,
    • “The percentage of U.S. adults who report doing any kind of gambling during the past year fell to 45%, down from 64% a decade ago, according to an Aug. 17 report from Gallup. 
    • “The findings are based on telephone interviews conducted by ReconMR June 1 to July 19, 2026, with a random sample of 2,201 adults, aged 18 and older, living in all 50 U.S. states and the District of Columbia. Gallup also conducted a web survey from June 1-15, 2026, with a stratified random sample of 2,043 adults, aged 18 and older, who are members of the Gallup Panel.’ 

From the U.S. Office of Personnel Management front,

  • FedWeek lets us know,
    • “The [Federal Employee Benefits] open season this year will run November 9-December 14. Available plans and their premiums for the upcoming year typically are announced a month or so in advance, with fuller details released just ahead of the enrollment period.”
  • OPM Director Scott Kupor made his latest post to his Secrets of OPM blog available on LinkedIn today. The post concerns a recent OPM employee survey.

From the Food and Drug Administration front,

  • CBS News reports,
    • “The Food and Drug Administration upgraded a recall of frozen blueberries and mixed berries sold at Publix grocery stores across the U.S. to the highest health risk level on Tuesday, according to an enforcement report.” 
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) to reduce daily cornstarch intake as an adjunct to nutritional management in adults and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa), a rare, inherited genetic disorder caused by a deficiency of the enzyme glucose-6-phosphatase, which prevents the body from properly breaking down stored glycogen into glucose. Genglycos is the first approved treatment for this condition.
    • “The accelerated approval pathway allows the FDA to approve certain drugs or biologics intended to treat a serious or life-threatening disease or condition if the agency determines the treatment has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
    • “Patients with GSDIa face possible life-threatening complications and have limited treatment options that include primarily life-long, strict dietary management,” said Karim Mikhail, B. Pharm., M.S., acting director of the Center for Biologics Evaluation and Research (CBER). “Today’s approval is a great milestone in using a gene therapy to treat this disease and improve the quality of life for people with this condition.”
  • and
    • “The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time, which may help address the current phlebotomist shortage in the U.S.
    • “This authorization reflects the FDA’s commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists.”
  • Fierce Pharma tells us,
    • “After more than 10 years in development, Regeneron secured a landmark approval for its monoclonal antibody garetosmab, now commercially known as Pasatru. The drug has become the second cleared by the FDA to treat fibrodysplasia ossificans progressiva (FOP) and the first to reduce clinician-assessed flare-ups in adults with the disease.
    • “Pasatru, given intravenously every four weeks, is designed to block what is believed to be the key protein behind the FOP disease process—activin A—which was pinpointed by Regeneron scientists as a possible target for treating FOP more than a decade ago. 
    • “The approval follows a victory last year in a phase 3 study, which randomized 63 adults with FOP to receive one of two doses of the anti-activin A antibody or placebo every four weeks for 56 weeks. In the trial, both high- and low-dose Pasatru reduced new bone lesions in FOP patients by 90% over 56 weeks. And high dose Pasatru reduced bouts of painful localized inflammation by 89% compared to placebo, too.
    • “By the end of the trial, an independent data monitoring committee recommended all patients on placebo be switched to Pasatru as soon as possible.” 

No Surprises Act News,

  • Modern Healthcare reports,
    • “Providers are triumphing against insurers in bitter out-of-network billing battles at a record pace and by an unprecedented margin.
    • “President Donald Trump enacted the No Surprises Act in 2020. The law succeeded in protecting patients from many surprise medical bills. But its baseball-style arbitration system was quickly overwhelmed.
    • “Independent Dispute Resolution filings represent a tiny percentage of commercial health insurance claims, but cases have increased each year since the process debuted in 2022. Disputes rose almost 75% to more than 2.5 million from 2024 to 2025, according to an analysis of Centers for Medicare and Medicaid Services data the Niskanen Center published in July. CMS originally projected there would be about 17,000 cases a year.
    • “Providers won 83.6% disputes in the fourth quarter of 2025, a share that’s been consistent since 2023, according to the Niskanen Center, a centrist think tank.
    • “Provider groups maintain these wins are warranted and arbitrators have agreed. Publicly held insurers including UnitedHealth Group subsidiary UnitedHealthcare, CVS Health subsidiary Aetna and Elevance Health contend out-of-network providers are abusing the system. Last month, CMS acknowledged arbitration is not working as intended and suggested it would take action.
    • “When we look at other models of arbitration, the win rates tend to be 50-50, and it tends to be a pretty rare option of last resort,” said Christopher Whaley, a health economist at Brown University. ”Obviously, that’s not happening in the No Surprises Act arena.”
  • FEHBlog observation: The NSA IDR rules stack the deck in favor of the providers who have inside information on the provider’s credentials and the patient’s acuity.

From the judicial front,

  • Fierce Pharma reports,
    • “In their attempts to challenge the Medicare drug price negotiation program, introduced by former President Joe Biden under the Inflation Reduction Act (IRA), biopharma companies have been largely shut out in federal courts.
    • “On Tuesday, however, Teva Pharmaceuticals gained a partial win as the U.S. Court of Appeals for Washington, D.C. sent (PDF) a previous ruling back to the District Court for further review. It concerns Teva’s challenge to the requirement by the Centers for Medicare & Medicaid Services (CMS) that a generic drug be genuinely marketed before its brand-name reference product is excluded from negotiation.
    • “The appeals court did not decide on the legality of the CMS’s “bona fide marketing” standard. It only determined that it should be considered by the lower court. 
    • “The district court never addressed whether CMS’s standard comports with the IRA, and we leave that question for it to consider in the first instance,” Circuit Judge J. Michelle Childs wrote.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Packaged-food makers are testing new strategies to appeal to consumers using GLP-1 weight-loss drugs, which suppress hunger and alter taste.
    • “JPMorgan estimates that GLP-1 treatments could drain $30 billion to $55 billion in annual revenue from the food and beverage industry by 2030.
    • “Companies like Conagra and General Mills are developing protein-rich products aimed at GLP-1 users.”
  • Health Day adds,
    • “Are you worried that extra pounds might be harming your health?
    • “Check the notches on your belt, a new study suggests.
    • “Waist size might be one of the simplest and most effective measures to detect health risks associated with obesity, researchers reported recently in JAMA Network Open.
    • “Pay attention to the need to loosen your belt or get bigger pants,” lead researcher Dr. Aayush Visaria said in a news release. He is a faculty member at Rutgers Health-RWJBarnabas Health Center for Climate, Health, and Healthcare in New Jersey. 
    • “Although clothing size isn’t the same as a proper waist circumference measurement, it can be an early sign of unhealthy amounts of body fat,” Visaria said. “Measuring your waist, along with your weight, can help identify health risks earlier and provide an opportunity to reduce your risk of diabetes, heart disease, stroke and some cancers.”
  • Cardiovascular Business relates,
    • “Rates of heart failure (HF) in the United States are stable or even beginning to decline. When it comes to HF with preserved ejection fraction (HFpEF), however, the numbers are on the rise. 
    • “This prompted the American College of Cardiology (ACC) to create an expert consensus decision pathway document focused on the efficient management of HFpEF patients.[1]
    • “The new document represents an update of the ACC’s 2023 recommendations, exploring new data to provide an abbreviated, practical guidance for patient management. The format was revised to associate treatment algorithms and tables to match the evolving clinical evidence.
    • “Despite advances in HF therapy, it remains a major consumer of healthcare resources and death worldwide. HFpEF accounts for more than 50% of new cases of HF each year and has outcomes comparable to heart failure with reduced ejection fraction (HFrEF). However, the consensus authors said HFpEF is often underdiagnosed and results in substantial resource utilization.”
  • and
    • “The use of artificial intelligence (AI) to identify incidental cardiac findings is a growing area of research, and now the identification of aortic stenosis (AS) is being tested on noncardiac chest CT scans. Cedars-Sinai Medical Center researchers are conducting a real-world study of an opportunistic algorithm that looks at all chest scans for the hallmark signs of AS.
    • “Some imaging experts have said this specific use of AI could serve as an early screening system to catch patients with heart disease years before they would become symptomatic, adding diagnostic value beyond why these scans were originally ordered. AS is one of the most common and serious heart valve disease problems, but most patients are unaware they have it at first and go undiagnosed until they become symptomatic. The American Heart Association (AHA), for example, believes there is still a sizable population of patients who remain undiagnosed or untreated.” 
  • Medscape offers physicians “Five Steps to Earlier Heart Failure Detection.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded scientific team has shown that under the right circumstances, 3D cell culture models of human brain tissue, known as organoids, can express features of later stage brain development. This breakthrough could turn previously unattainable, long-term, benchtop studies of neurodevelopmental disorders into a reality.
    • “The unprecedented longevity and lifelike qualities of these tissue models could afford us the opportunity to dig deeper into how conditions such as autism emerge and unfold later in life,” said Andrea Beckel-Mitchener, Ph.D., acting director of NIH’s National Institute of Mental Health (NIMH).”
  • Genetic Engineering and BioTechnology News adds,
    • “The Human Cell Atlas (HCA) was co-founded in 2016 by Aviv Regev, PhD, currently the head, executive vice president of research and early development at Genentech and Sarah Teichmann, FMedSci FRS, professor at the University of Cambridge and vice president translational research at GSK.
    • “This year, the group celebrated its 10-year anniversary, at the annual meeting in June, held in Boston. The first day was focused on the successes of the past decade. The second day looked ahead to the future, and the impact the HCA will make on research and drug discovery. GEN spoke with Holger Heyn, PhD, ICREA professor at the Centro Nacional de Análisis Genómico (CNAG) and co-founder of Omniscope about the meeting and what the next 10 years may bring. Heyn has been with the HCA since (almost) the beginning and currently serves as the co-chair of the Standards and Technologies working group, co-chair of the Industry Partnership Program, an organizing committee member, and a member of the task force to design HCA 2.0.”
    • The interview can be found in the article.
  • In the big research news of the day, the New York Times informs us,
    • “An experimental mRNA vaccine allowed people with high-risk melanoma to live longer, cancer-free, the pharmaceutical companies Moderna and Merck announced Wednesday.
    • “For decades, cancer vaccines have been one of the most tantalizing ideas in cancer treatment — offering the hope of harnessing a person’s own immune system to attack tumors.
    • “It’s a big deal,” said Dr. Elias Sayour, a pediatric oncologist at the University of Florida, who was not involved in the trial. The results, he said, “could help usher a whole new wave of new therapeutic treatments for cancer.” * * *
    • “The study is the most advanced of a number of trials testing the approach against a variety of cancers, including lung, bladder, kidney and pancreatic cancer. While small trials have shown the promise of the approach, the Moderna and Merck trial was seen as a bellwether in demonstrating the technology — and a first step toward transforming cancer care with treatments that are individualized to a person’s tumor and that may ultimately be able to stay ahead of it as it changes.”
  • The Wall Street Journal adds,
    • “Novo Nordisk is studying smaller doses of its Wegovy weight-loss pill to find the lowest dose that still allows patients to lose weight.
    • “The study began last week, has enrolled 450 overweight people and will test two low doses of the pill compared to a placebo.
    • “Novo Nordisk recently disclosed that uptake of the pill has been particularly strong for its lowest doses across self-paying patients.”

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

  • The Association of Healthcare Journalist reports,
    • “Investing more in primary care is linked to lower health care costs, according to a new report.
    • Journalists can cover this story nationally and locally, especially in rural areas where access to primary care can be more challenging, according to the report, “Investing in Primary Care: The Missing Strategy in America’s Fight Against Chronic Disease,” from the Milbank Memorial Fund.
    • “The report matters to reporters because it shows that adults and children with primary care physicians (PCPs) or a regular source of primary care have lower health care costs than those without.
    • “The report comes as Congress and President Trump are implementing changes under the 2025 budget reconciliation bill, cutting billions of dollars in federal Medicaid spending. Such a big decrease means low-income families could lose their Medicaid coverage, and not all physicians will treat the uninsured, the Milbank report notes. 
    • “The Milbank report is also timely because federal efforts since 2021 to increase the number of primary care doctors “have fallen short”, as Dennis Thompson reported for HealthDay. Primary care positions increased by just 2% under laws Congress passed in 2021 and 2023 to increase U.S. medical residencies, while residency positions in interventional radiology and psychiatry increased the most, rising by 16% and 13% respectively, he wrote, citing research JAMA published in June.” 
  • Beckers ASC Review adds,
    • “Physicians who once worked in a physician-owned practice before their current job are significantly more likely than their peers to be heading for the exit, according to the 2026 PAI Employed Physician Survey.
    • “Among physicians with prior experience in a physician-owned setting, 35% cite a lack of clinical autonomy as a reason they’re considering a new job, compared with 21% of physicians who’ve never practiced outside a corporate structure. They’re also more likely to say they plan to leave clinical practice entirely before retiring — 20% versus 12%.
    • “That group also reports operating under tighter terms: 63% are bound by a non-compete agreement, versus 48% of physicians without prior independent-practice experience, and 53% have patient-volume targets built into their compensation, versus 41%.”
  • Beckers Hospital Review relates,
    • “Altamonte Springs, Fla.-based AdventHealth recorded operating income of $916.2 million (13.4% operating margin) during the second quarter of 2026, up from $657.4 million (11.7% margin) during the same period last year.”
  • Beckers Health IT tells us,
    • “A year ago, health system CIOs walking the halls of Epic’s Users Group Meeting were still convincing themselves — and their boards — that generative AI in the EHR was more than a demo. This year, that debate is over. The new one is about speed.
    • “What strikes me overall is just the pace is blistering,” Tom Bentley, BSN, RN, chief information and digital technology officer of Columbus-based Ohio State University Wexner Medical Center, told Becker’s at the EHR giant’s sprawling headquarters in Verona, Wis. “Epic is cranking out new functionality, and I’m thinking what every CIO is thinking about: How do we increase our pace of adoption?”
    • “Epic used its Aug. 18 keynote to detail the scope of that push, including its Agent Factory platform that will soon allow health systems to build their own AI agents, the advancement of Cosmos-powered prediction tools called Curiosity, and the debut of an AI-assisted outpatient visit called Ergo.”
  • Beckers Payer Issues adds,
    • ‘The health systems and health plans that have pushed AI furthest into their operations are among the least equipped to prove what it is returning, according to a survey of 64 U.S. healthcare CFOs and finance leaders published Aug. 12 by Deloitte.
    • ‘Only 18% of organizations Deloitte classified as “AI scalers” said they have mature financial attribution capabilities, meaning they consistently measure AI’s effect on revenue growth or cost savings with defined baselines and clear ownership of key performance indicators. Among “AI starters,” 31% reported that level of maturity.’

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) through the Administration for Children and Families (ACF) today added new peer support programs to the Title-IV Prevention Services Clearinghouse, for which all states can now claim federal reimbursement. The expansion advances the Trump Administration’s Great American Recovery and A Home for Every Child initiatives by equipping states with evidence-based resources to help parents overcome addiction, thereby strengthening families and reducing the number of children entering foster care.
    • “HHS Secretary Robert F. Kennedy Jr., White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Initiative Kathryn Burgum, and ACF Assistant Secretary Alex J. Adams joined Governor Kim Reynolds in Des Moines to make the announcement.
    • “Addiction tears families apart. Recovery brings parents home and keeps children with the families who love them,” said HHS Secretary Robert F. Kennedy, Jr. “Under President Trump’s Great American Recovery, we are expanding proven peer support that helps parents overcome addiction, strengthens families, and keeps children out of foster care.”
    • “Iowa is proud to be first in the nation to adopt new peer-support interventions,” said Iowa Governor Kim Reynolds. “By responding to addiction and supporting struggling families, we’re building a stronger America: one where recovery is real, every child has a home, and hope is never out of reach for anyone.”
  • Federal News Network relates,
    • “Kevin Rhodes, the administrator of the Office of Federal Procurement Policy, is leaving federal service.
    • “A person with knowledge of the situation confirmed that Rhodes’s last day will be Sept. 4.
    • “The Senate confirmed Rhodes in October 2025, making him the first permanent OFPP administrator since 2019. He started working at OMB as a senior advisor in February 2025.
    • It’s unclear who will be acting OFPP administrator once he leaves.”
  • Fierce Healthcare tells us,
    • “The American Medical Association (AMA) said Monday it “welcomes” updated guidance from the U.S. Centers for Medicare and Medicaid Services (CMS) that strengthens federal transparency requirements for prior authorization.
    • “The country’s largest physician organization had documented concerns and recommended specific corrective actions to the agency in May (PDF), following the group’s review of how 15 Medicare Advantage contracts were implementing transparency provisions of the CMS Interoperability and Prior Authorization final rule. 
    • “The 2024 final rule requires payers to publicly post prior authorization requirements and outcomes, with a three-day deadline for urgent requests and a seven-day deadline for standard requests.” * * *
    • “The updated metrics reporting framework (PDF) clarifies that posting required metrics only through password-protected portals or “other locations that cannot be reached through ordinary navigation from the payer’s public-facing website” does not satisfy the rule’s “publicly accessible” requirement.
    • “The agency now also specifies that plans must publicly identify all medical items and services requiring prior authorization and identify omission of entire categories of care from disclosures. Moreover, it clarifies disclosures must be understandable and turnaround-time metrics must include a unit of time.”
  • The American Hospital Association informs us,
    • “The Centers for Medicare & Medicaid Services yesterday announced the launch of QualTech, a new event created to identify innovative technology that improves health outcomes. CMS is seeking participants from U.S-based teams, academic institutions, nonprofit organizations, private sector companies, industry associations and other stakeholders to propose technology solutions in advance of the event. Applicants must align proposal submissions to one of four priority opportunity areas: using artificial intelligence to protect patients and strengthen healthcare quality; leveraging AI to increase annual wellness visits in Medicare; proposing a next-generation digital quality measure calculator; and supporting the development of a national quality hospital dashboard. CMS will select finalists to present at QualTech, which will be held at CMS headquarters, to CMS and Center for Clinical Standards and Quality leadership and other attendees. CMS said it may continue engagement with select organizations following the event, which could include future demonstrations, pilots, collaboration discussions and a potential role in the 2027 CMS Quality Conference. Applications must be uploaded to the QualTech submission link by Sept. 4, 2026.” 
  • Managed Healthcare Executive points out,
    • “CMS implemented MFPs for 10 high-volume Part D drugs in January 2026 after 2024 discount announcements, with projected net savings of ~$6 billion (≈22%) across those products. 
    • “Surveyed beneficiaries reported countervailing cost signals: 46% paid more for at least one negotiated drug, 39% saw premium increases, and coverage changes increased out-of-pocket exposure for 29%. 
    • “Access friction intensified, with 30% reporting 2026 barriers versus 25% in 2025, most commonly prior authorization and drug availability constraints. 
    • “Knowledge gaps were substantial, as ~40% were unaware of the $2,100 out-of-pocket cap or the Medicare Prescription Payment Plan, undermining uptake of IRA cost protections. 
    • “Payer responses appear consistent with broader market behavior, including expanded step therapy, higher premiums, and stronger generic/biosimilar preferencing, particularly affecting diabetes, dermatology, and rheumatology.”

From the U.S. Office of Personnel Management front,

  • Fedweek reports,
    • “OPM has told agencies that they “must verify 100 percent of Open Season elections in which a family member is added” in FEHB/PSHB enrollments for calendar year 2027, sending them a survey for them to verify their readiness to do so.
    • “Enrollment of ineligible persons has been a long-running issue, the subject of congressional oversight and reports from the OPM inspector general and the GAO—most recently, in a GAO report on high-priority recommendations to the agency. The cost of claims from ineligible persons is widely estimated at $1 billion a year, raising premium costs for both enrollees and the government.
    • “In a benefits administration letter dated July 15 but only recently posted, OPM noted scrutiny has been tightened in a series of administrative steps, including in a prior letter requiring at least 10 percent of new family member enrollments and recommending review of all. Language in a broader budget measure enacted last year “codifies and elevates this standard by requiring verification of family member eligibility when an enrollee adds a family member during Open Season,” it said.
  • and
    • “Recently finalized rules requiring that employee performance evaluations fit a mandated pattern will apply to the rating cycle closing next month, OPM has said, a process that will involve “calibration” by senior agency officials that potentially will reduce many of the ratings set by employees’ supervisors.
    • “While a recent memo on carrying out the changes does not specify an implementation schedule, in response to questions from FEDweek, OPM said that what it calls “standardized” rating “applies to both the FY26 and FY27 performance appraisal cycles.”
    • “Agencies must establish a calibration program for the FY26 performance appraisal closeout no later than September 20, 2026 (end of FY26 appraisal cycle). Additionally, agencies must design their new GS performance management systems, and have them approved by OPM, prior to October 1, 2026 (for FY27 implementation),” it said.
    • “Applying a standardized distribution of ratings, and designing and implementing a calibration program, is effective for the closeout of the FY26 cycle,” it said, adding that it “will be publishing FY2026 performance appraisal cycle close-out guidance separately. We expect that guidance to be released in the next few weeks.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “President Donald Trump has chosen White House policy aide Heidi Overton to lead the Food and Drug Administration, according to a person familiar with the matter, after a turbulent year at the agency marked by high-profile staff exits and industry complaints.
    • “Overton is a deputy assistant to the president for domestic policy at the White House working on health issues. She previously worked at the think tank America First Policy Institute. Overton is a medical doctor and has a doctorate in clinical investigation from Johns Hopkins University. She was also a White House fellow in the first Trump administration.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial intelligence-enabled medical devices. The paper includes considerations for risk assessment, premarket evaluation, post-market monitoring and other areas. The agency intends to gather early stakeholder input and advance broader discussion on policy frameworks for generative AI. The FDA said comments must be submitted by Oct. 19.”  
  • MedPage Today adds,
  • Per a corporate news release,
    • “LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA) has approved an autoinjector for LEROCHOL® (lerodalcibep-liga) Injection 300 mg/1.2 mL, a third-generation Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor that combines robust and sustained efficacy with once-monthly, single injection self-administration to support long-term adherence.
    • “The FDA also approved an update to the LEROCHOL indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events (MACE) achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy.” * * *
    • “LEROCHOL autoinjector is expected to be available by January 2027 with a direct-to-patient cash price to match that of the already available pre-filled syringe at $199 per month.
  • BioPharma Dive explains that an “FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax.”
    • “Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.”

From the judicial front,

  • Beckers ASC Review reports,
    • “The American Association of Nurse Anesthesiology said July 21 that a U.S. Court of Appeals for the Sixth Circuit ruling wrongly declined to force HHS to enforce a provider nondiscrimination provision that protects certified registered nurse anesthetists from reduced insurance reimbursement.
    • “The Sixth Circuit based its ruling on associational standing, upholding a lower court’s finding that AANA lacked standing to bring the case. Mr. Molter said AANA is evaluating what the decision means for how trade associations pursue their members’ interests in federal court and is urging other associations to do the same.
    • “AANA President Jeff Molter, MSN,  MBA, CRNA, said the ruling does not endorse insurers’ practice of reimbursing CRNAs less than physician anesthesiologists for the same services. He called the decision procedural and said AANA maintains that such reduced reimbursement remains unlawful and discriminatory under current statute.”
  • The article points out nine other current anesthesia controversies.
  • Bloomberg Law relates,
    • “A federal judge in Massachusetts mostly upheld a 2025 Trump administration rule tightening oversight of Affordable Care Act exchange enrollment, adding to the legal saga dragging on over a 2026 version of the annual rule.
    • “Judge Nathaniel M. Gorton of the US District Court for the District of Massachusetts on Friday granted summary judgment for the administration in regard to provisions reducing the grace period for premium tax credit recipients to reconcile their income from two years to one year, shortening states’ open enrollment periods, increasing insurers’ flexibility to decrease the value of their plans, and changing the methodology for calculating cost-sharing amounts.
    • “But Gorton sided with the states in determining the administration did not follow the law in excluding certain “sex-trait modification procedures” from the ACA’s essential health benefits, noting that the government refused to issue a mandated report to Congress certifying that the provisions were aligned with a “typical employer plan.”
    • “When asked about the issue at oral argument, the government maintained its position that the Agency is not required to submit such a report, notwithstanding the Court’s clear ruling that it was required to do so,” he wrote in his opinion.” * * *
    • “Gorton’s opinion conflicts with the Maryland court, which rejected CMS’s ability to limit enrollment periods and increase flexibility for insurers to vary the value of their plans.
    • “CMS finalized several of the same provisions in its 2026 rule, prompting Democratic cities and states to sue again. The rule is now mostly frozen by the Maryland court.
    • “The case is California v. Kennedy , D. Mass., No. 1:25-cv-12019, opinion filed 8/14/26.”
  • The AP informs us,
    • “Luigi Mangione’s state murder trial in the killing of UnitedHealthcare CEO Brian Thompson, which was slated to begin Sept. 8, has been postponed indefinitely as his lawyers seek to have the case thrown out on double jeopardy grounds following his guilty plea last week to federal charges.
    • “Judge Gregory Carro issued an order Monday canceling the trial and giving the Manhattan District Attorney’s office, which is prosecuting the state case, until Oct. 9 to respond to the defense’s double jeopardy claims. A hearing will be held on Dec. 10, Carro said, about a week before Mangione is scheduled to be sentenced in the federal case.”

From the public health and medical / Rx research front,

  • The New York Times lets us know,
    • “What the Newest Research on Wildfire Smoke Tells Us
      • “Scientists have found that people are being exposed to more toxins than previously known.”
  • Cardiovascular Business adds,
    • “Long-term exposure to air pollution is associated with more advanced coronary atherosclerosis, including greater plaque burden and obstructive coronary artery disease, according to a large cardiac CT study published in Radiology.[1]
    • “Researchers led by Kate Hanneman, MD, MPH, associate professor and vice chair of research in the department of medical imaging at the University of Toronto, analyzed cardiac CT data from 11,128 adults who underwent clinical scans at three Toronto hospitals between 2012 and 2023. The study linked patients’ residential postal codes with air-quality data to estimate their average exposure to pollution during the 10 years before their CT examinations.
    • “What we found is that higher air pollution exposure, both gaseous and particulate, was associated with higher coronary calcium scores, higher plaque burden, and obstructive coronary disease in unadjusted models,” Hanneman explained a video interview with Cardiovascular Business at SCCT2026, the Society of Cardiovascular Computed Tomography (SCCT) annual meeting. “When we adjusted for age, sex, and traditional cardiovascular risk factors, we found that in women, higher air pollution was also associated with obstructive disease, even in these multi-variable models. So this really builds on the existing literature that tells us that higher air pollution is not good for us and it’s not good for our heart.”
  • Genetic Engineering and Biotechnology News reports,
    • “Mass General Brigham Cancer Institute researchers found that consuming one or more sugar-sweetened beverages every day was associated with an increased risk of developing gastric cancer, while artificially sweetened beverages were not associated with an increased risk. Results from the study were published in Gastro Hep Advances, in an article titled “Association between sugar-sweetened and artificially sweetened beverage intake and gastric cancer incidence.”
    • “Previous research has linked sugar-sweetened beverages with an increased risk of colorectal, breast, and liver cancers, but evidence on gastric cancer has been limited. The study analyzed data from 112,284 participants in the Nurses’ Health Study and Health Professionals Follow-Up Study. Both studies gathered detailed diet, lifestyle, and health information on U.S. adults over many decades. During the follow-up period, which spanned decades, 278 participants developed gastric cancer.
  • MedPage Today adds,
    • “A group of physicians and scientists are calling on the National Collegiate Athletic Association (NCAA) to make changes to its massive collaboration between Big 12 athletics and Monster Energy, citing potential health risks and teen deaths associated with energy-drink consumption.
    • “As part of the partnership announced last month, Big 12 football and basketball athletes will don Monster Energy-branded jerseys during the regular seasons, and the fields and courts where teams play will display the popular energy drink’s logo.
    • “Virginia-based ophthalmologist David Jacobs, MD, noticed the prominent branding of the energy drink when he went to visit his kid’s Big 12 school, and later became concerned about how the campaign could influence children.
    • “Jacobs is an alum of a Big 12 school, as is his friend, Idaho-based cardiologist Matthew Nelson, MD. The two began reaching out to other cardiologists and created the Protect Young Fansopens in a new tab or window public health initiative, which, as of press time, has gathered over 250 signatures on their petitionopens in a new tab or window asking the NCAA to end the Monster Energy partnership.
    • “We’re concerned about an increase in energy drink consumption among children and youth,” Jacobs told MedPage Today. He noted that with high-profile Big 12 sports in particular, impressionable kids will be looking up to and copying their sports idols.
    • “Their concerns are not abstract, according to an email to NCAA leadership from Jacobs, Nelson, and other physicians and scientists that was shared with MedPage Today.”
  • The American Hospital Association News relates,
    • “For the 2025-2026 school year, exemptions from one or more vaccines among U.S. kindergartners was at 4.2%, increasing from 3.6% for the previous school year, according to data released yesterday by the Centers for Disease Control and Prevention. Exemptions rose in 41 states and Washington, D.C. Vaccination coverage declined for all reported vaccines from the previous year. Coverage with the measles, mumps and rubella, or MMR; diphtheria, tetanus, and acellular pertussis, or DTaP; polio and varicella vaccines decreased in more than half of states. The CDC said there were approximately 280,000 kindergartners that attended school in 2025-2026 without documentation of completing the two-dose MMR vaccine.” 
  • MedPage Today adds,
    • :The hepatitis A vaccine is recommended for high-risk children and adults, while the hepatitis B vaccine is recommended for all adults under 60 years.
    • “In this study, researchers estimated that 40% of U.S. adults had immunity to hepatitis A and 27% were immune to hepatitis B virus.
    • “Levels of immunity against hepatitis A and hepatitis B viruses were “suboptimal” and persisted across high-risk groups, according to the researchers.”
  • and
    • “Despite routine rotavirus vaccination in over 140 countries, the virus still causes an estimated 25% of diarrhea deaths in children younger than 5 years.
    • “In a retrospective study of children ages 3 months to 4 years, receiving at least one dose of a rotavirus vaccine was 75.8% effective at preventing rotavirus-positive acute gastroenteritis death.
    • “Rotavirus vaccination was less effective against all-cause acute gastroenteritis mortality, at 20.8%.”
  • Beckers Clincal Leadership tells us,
    • “Blacklegged ticks carrying Lyme disease have expanded into the mountains of western North Carolina, far south of the disease’s traditional Northeast and Upper Midwest range, according to an Aug. 13 CDC report.
    • “Researchers surveilling 22 residential properties in Biltmore Forest, N.C., near Asheville, collected 373 ticks from November 2024 through August 2025, according to the CDC’s “Morbidity and Mortality Weekly Report.” Blacklegged ticks — the primary Lyme vector — made up 287, or 76.9%, of them.
    • “Nearly 40% of the adult blacklegged ticks, or 19 of 48 specimens, tested positive for Borrelia burgdorferi, the bacterium that causes Lyme disease. Three of seven nymphs also carried it.
    • “Nineteen residents across 17 households reported at least one tick-borne illness while living in the town, the CDC report said. Lyme disease was the most common, with 17 cases, followed by two cases of babesiosis and one of ehrlichiosis.
    • “The findings point to an emerging clinical blind spot. Many clinicians across the South have little experience diagnosing or managing tick-borne disease, the report’s authors said, and may not consider Lyme in patients with no travel history to endemic regions.”
  • Beckers Hospital Review informs us,
    • “Nearly every U.S. hospital screens patients for sepsis, but far fewer have dedicated personnel to ensure screening is successful, the CDC found. Moreover, separate research links a lack of specific accountability to higher mortality.
    • “In its latest annual survey of hospital sepsis programs, covering 2025, the CDC found that 93% of 5,430 hospitals have a standard process to screen for sepsis and 87% use order sets tailored to their patients. But only 36% employ a sepsis coordinator to oversee day-to-day operations, and 32% have support from staff with expertise in data, analytics and information technology.
    • “When it comes to reporting, 31% of hospitals share sepsis data with nursing, physician, unit and hospital leadership at routine intervals. At the remaining two-thirds of U.S. hospitals, that data does not reach leaders on a regular basis.
    • “Sepsis accounts for about 1.7 million adult hospitalizations per year, 350,000 of which end in death or discharge to hospice — more than a third of all hospital deaths, according to the CDC.”
  • The American Medical Association lets us know “this superbug’s toll exceeds 3,400. How to protect your loved ones.”
    • “The Candida auris fungus is spreading. Here’s what to know about the superbug, who’s most at risk, symptoms and what your next steps should be.”
  • Health Day points out,
    • “Many smokers still haven’t absorbed the fact that smoking and secondhand smoke cause heart attacks and strokes, despite decades of messaging around tobacco’s health risks, a new study says.
    • “More than 90% know that smoking causes lung cancer, but fewer know about its links to other fatal conditions, researchers report in the journal BMJ Open.
    • “Only about 80% knew smoking contributes to heart disease and heart attacks, and 70% are aware it causes strokes, researchers found.
    • “In fact, across two decades they found almost no progress in knowledge of the health risks associated with smoking.
    • “Knowledge gaps about the major health effects of smoking and secondhand smoke are deeply concerning,” said lead researcher Janet Chung-Hall, a research scientist for the International Tobacco Control Policy Evaluation Project at the University of Waterloo in Canada.”
  • and
    • “There’s been a nearly 400% increase in calls to U.S. poison centers related to liver injuries, mostly related to Tylenol and other medications, a new study says.
    • “Liver injuries caused by foreign substances skyrocketed from an estimated 11 cases per million people to nearly 53 cases per million between 2000 and 2024, researchers reported Aug. 13 in the journal Clinical Gastroenterology and Hepatology.
    • :Medications accounted for most of these liver injuries, including 85% of cases among men and 94% of cases among women, researchers found.
    • “Acetaminophen (Tylenol) was the drug most frequently implicated in liver injuries reported to poison centers, researchers said. About 33% of men and 45% of women reported injuries due solely to Tylenol.”
    • “Liver injuries reported to poison centers have increased substantially over the past 25 years, with acetaminophen emerging as a growing contributor,” researcher Dr. Christopher Holstege, director of the University of Virginia Health’s Blue Ridge Poison Center, said in a news release.”
  • Per BioPharma Dive,
    • A once high-flying Boston-area drug company mounted somewhat of a comeback Tuesday, reporting positive results from a clinical trial testing a potentially first-of-its-kind treatment for the dangerously low blood sugar levels some patients experience after bariatric surgery.
    • Amylyx Pharmaceuticals said its medicine, known as avexitide, hit the main goal of the late-stage study by spurring a 55% reduction in serious to severe hypoglycemic events compared to a placebo. Such events starve the brain of the sugar it needs for fuel, leading to confusion, dizziness, slurred speech and loss of coordination. In more dire cases, patients can faint, have seizures or become comatose.
    • “According to Amylyx, its medicine also appeared safe. Researchers classified a majority of the adverse events seen in the trial as mild or moderate, with the most common being diarrhea and bruising or redness at the injection site. Amylyx now plans to, before the end of the year, formally ask the Food and Drug Administration to approve avexitide.”

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

  • Healthcare Dive reports,
    • “CVS has added Teresa Heitsenrether, JPMorgan Chase’s chief data and analytics officer, to its board of directors as the healthcare behemoth continues to progress on its financial turnaround.
    • “Heitsenrether has spent four decades in financial services, according to Monday press release announcing her appointment. She’ll be joining CVS effective Nov. 18.
    • “CVS also said that Larry Robbins, who served on the board’s audit and public policy and external affairs committees, left earlier this month. Robbins, the CEO of Glenview Capital Management, joined the board in 2024 after the hedge fund pushed for changes at CVS.”
    • “As the leader of JPMorgan’s data and analytics, Heitsenrether sets strategy and governance standards, while driving the bank’s adoption of artificial intelligence.”
  • Beckers Payer Issues relates,
    • “UnitedHealthcare expanded its child and family behavioral coaching program, giving approximately 13 million eligible commercial members access to behavioral health support. 
    • “The 2026 expansion adds access for an additional 5 million members at no added cost for employers with fully insured plans. More than 500 employers now offer the program, according to an Aug. 18 news release from the company. 
    • “The program addresses mild to moderate anxiety, attention-deficit/hyperactivity disorder, bullying, depression and sleep difficulties, with participants being 12 years old on average. It offers up to four virtual coaching sessions per month, appointments within 48 hours, unlimited secure messaging and educational resources, and access to health and wellness coaches. Members can also be referred to licensed clinicians when higher-level care is needed.”
  • and 
    • “Blue Cross Blue Shield of Tennessee has the highest-ranked Medicare Advantage plan for member satisfaction in 2026, according to JD Power’s 12th annual Medicare Advantage study.
    • “The consumer insight firm published its annual ranking of the top MA plans in 12 markets on Aug. 18 after surveying more than 14,500 enrollees and evaluating plans on eight factors, including level of trust, ability to get health services when and how members want, helping save time or money, product and coverage offerings, ease of doing business, customer service representatives, problem resolution and digital channels.
    • “The average member satisfaction rating for MA plans this year is 611 on a 1,000-point scale, down 12 points from 2025 and down 41 points from 2024, marking a second consecutive year of decline.
    • “Satisfaction dropped across all dimensions of the member experience, with the largest two-year declines in areas tied to helping members save time and money, level of trust and whether coverage offerings met member needs. Fewer than half of plan members said they strongly agreed their plan is a trusted partner in their health and wellness. High-performing plans distinguished themselves through stronger new-member onboarding and communication, while special needs plans delivered significantly higher satisfaction and trust scores overall.”
  • Fierce Healthcare tells us,
    • “While operating margins trended upward in June, hospitals’ overall performance still lags 2025 and is seeing “intensifying” uncompensated care pressures and faster-than-inflation expense growth, according to the latest monthly benchmarks from Kaufman Hall. 
    • “The healthcare advisory firm reported a calendar year-to-date operating margin index of 2.5% and a single-month operating margin index of 4.5% (both including health system allocations for the cost of shared services). The former is a 6% lag compared to the first half of 2025, while the latter reflects a 6% bump over this May’s median operating margin.
    • “Echoing commentary from some of its preceding reports this year, Kaufman Hall’s primary red flag was a 2% month-over-month increase in daily bad debt and charity logged by hospitals, which year-to-date is 17% higher than the same cutoff in 2025. As a percentage of hospitals’ gross operating revenue, year to date, uncompensated care is 8% higher than 2025.” 
  • STAT News adds,
    • “For Bon Secours Mercy Health, Ensemble Health Partners is the gift that keeps on giving. 
    • “Seven years after the nonprofit health system sold stakes in its in-house billing and collections company to private equity investors, it still rakes in eye-popping amounts of cash from its minority position, with payments topping $1 billion so far this year.
    • “About two weeks ago, the Cincinnati-based system said it got a hefty $671 million payment from Ensemble Health Partners when the company signed a new private equity sponsor. That’s on top of a $427 million distribution Bon Secours Mercy recorded in February. Both payments were reported on the nonprofit system’s financial report for the second quarter, which ended June 30. 
    • “The $1.1 billion Bon Secours Mercy received from its 41% stake in Ensemble across the two payments far exceeds the system’s operating income in the first half of the year, which was $225 million. The health system generated $7.5 billion in revenue in the first six months of 2026, compared with $6.9 billion in the first half of 2025.” 
  • Beckers Hospital Review adds
    • “After years of high length-of-stay averages, hospitals are reporting significant length-of-stay reductions.”
      ,
  • Beckers Payer Issues notes,
    • “Montgomery, Ala.-based Jackson Hospital has filed to exit bankruptcy and signed a four-year deal with Blue Cross Blue Shield of Alabama, John Quinlivan, CEO of Jackson Hospital, said during an Aug. 17 news conference. 
    • “The BCBS agreement will become active once the exit is complete.
    • “The agreement does not give us everything we felt we needed, but combined with the continued support of Blue Cross Blue Shield of Alabama, Jackson Investment Group, the City of Montgomery, Montgomery County and the State of Alabama, it enables us to execute our strategic plan,” Mr. Quinlivan said. “We will enhance operational discipline, improve quality, expand services and add new services as we grow and innovate to better serve Montgomery and the Central Alabama region.”
  • Per Beckers Physician Leadership,
    • “Corporate entities now employ 82% of U.S. physicians, and about nine out of 10 physicians in employed settings are reporting symptoms of burnout, according to a new survey.
    • “The Physicians Advocacy Institute and Healthsperien’s Center for Health Research, Policy & Strategy surveyed more than 1,000 hospital- and corporate-employed physicians and found widespread burnout, administrative burdens and pressure to put corporate interests ahead of patient care.”
  • Per Fierce Healthcare,
    • “Four health systems are now using real-time prior authorization checks embedded in the Epic electronic health record, tackling a major pain point for providers.
    • “The electronic health record giant collaborated with insurers UnitedHealthcare, Network Health and Aetna to set up the electronic workflows to modernize the manual and time-consuming prior auth process.
    • “Epic launched real-time insurance reviews directly into EHR workflows using an industry-standard application programming interface (API) called Coverage Requirements Discovery (CRD). Epic is testing the API with 16 additional payers to support wider industry adoption, the company announced Monday as its annual Users Group Meeting kicks off in Verona, Wisconsin.”

Monday report

David Ermer–ACA, CDC, CMS, FDA, Medical / Rx research, Mental health care, OPM, Telehealth, U.S. Healthcare–

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.

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The House of Representatives Budget Committee lets us know,
    • “A new report from the Department of Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) finds reforms to Medicaid provider taxes and state-directed payments in The One Big Beautiful Bill will lower health care prices for Americans across the board.
    • “The report projects the reforms will reduce non-Medicaid health care prices by as much as 3.5 percent, generating between $502 billion and $875 billion in savings for taxpayers, families, and businesses over the next decade, with annual savings reaching $100 to $175 billion once the reforms are fully in place.
    • “The savings extend beyond Medicaid: ASPE estimates that every $100 billion in Medicaid savings produces another $29 billion in savings for Medicare and commercial coverage plans, which lowers health care costs and the tax burden for hardworking American families.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced that health systems represented by the past, current, and incoming chair of the American Hospital Association (AHA) have joined the Make Hospital Food Healthier Pledge, strengthening a nationwide effort to improve the quality of food served in America’s hospitals and reinforce the role of nutrition in patient care. Corewell Health in Michigan, Houston Methodist in Texas, and Sanford Health in South Dakota all signed onto the pledge.
    • “Hospitals cannot promote healing while serving food that contributes to chronic disease,” said HHS Secretary Robert F. Kennedy, Jr. “By joining this pledge, these health systems are putting nutrition where it belongs — at the center of patient care. We are working with hospitals across America to serve healthier food, improve patient health, and Make America Healthy Again.”
  • Fierce Healthcare reports,
    • “The Pharmaceutical Care Management Association announced Thursday that its members had reached an agreement with the feds to offer information on cash prices available through TrumpRx.
    • “The commitment encompasses nine of the industry’s leading pharmacy benefit managers, including the “Big Three” in CVS’ Caremark, UnitedHealth Group’s Optum Rx and Cigna’s Express Scripts. Other participants that have signed on include Elevance Health’s CarelonRx, Humana, MedImpact Healthcare Systems, Navitus Health Solutions, Prime Therapeutics, VtylOne and WellDyne.
    • “Members covered by these PBMs will be able to see costs for drugs purchased through TrumpRx when using their plan’s real-time benefit or other pricing tools, PCMA said.”
  • McKnight’s Homecare relates,
    • “In a new memo outlining the National Fraud Enforcement Division’s enforcement priorities in a variety of industries, the Department of Justice called out home health and hospice fraud as an area of focus in the healthcare sector.
    • “National healthcare expenditures are expected to grow from over $3 trillion a year to over $7 trillion, and estimates are that between 3–10% of that amount is lost to fraud,” the Aug. 13 memo from Colin M. McDonald, assistant attorney general, said. “Home health aide and hospice scams directly impact vulnerable elderly Americans and erode patient care.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Aug. 14 released a request for comments through the Office of the National Coordinator for Health IT on a proposed three-year generic clearance to collect routine customer feedback on service delivery and performance related to the Trusted Exchange Framework and Common Agreement. TEFCA is a nationwide network for health information sharing established by ONC to fulfill mandates under the 21st Century Cures Act. HHS said data collection under the clearance would be used to standardize monitoring and performance reports for TEFCA participants. Comments are due 30 days following publication in the Federal Register.”

From the U.S. Office of Personnel Management front,

  • Govexec reports,
    • “Federal wildland firefighters will soon have more opportunities to receive hazard pay in connection with their work fighting and preventing wildfires, thanks to newly finalized regulations from the Office of Personnel Management.
    • “Currently, federal firefighters are eligible for hazard pay—a 25% increase over their normal salary—only when working to extinguish an unplanned wildfire. But they do not receive this increased pay when working on prescribed burns, in which officials intentionally ignite decaying forest material in the hopes of mitigating the risk of an uncontrolled wildfire breaking out in the future.
    • “In a new rule published in the Federal Register Friday, OPM finalized its April proposal to expand firefighters’ access to hazard pay to include prescribed burns, effective Sept. 13. The regulation authorizes hazardous duty pay for prescribed burns for firefighters hired under the “General Schedule pay sale, as well as environmental differential pay for those serving under the Federal Wage System.
    • “But OPM noted that the new hazard pay will not be available for every activity associated with a prescribed burn.
  • Also in today’s Federal Register, OPM issued a new direct final rule. Here is the summary and comment information:
    • SUMMARY: Pursuant to the President’s direction in Executive Order 14410, Implementing Schedule Policy/Career in the Excepted Service, the Office of Personnel Management (OPM) is issuing a direct final rule to update and amend obsolete and outdated provisions of the
    • Civil Service Rules that do not substantively affect agency operations.
    • DATES: This rule is effective October 13, 2026, unless significant adverse comments are received by September 14, 2026. If significant adverse comments are received, OPM will withdraw the relevant provisions of this direct final rule.
  • Federal News Network relates,
    • “Retirement is supposed to be the payoff for decades of saving, planning and serving the federal government. But for some federal employees, the first year of retirement can bring surprises they never saw coming, whether that be a delayed pension, a tax bill that looks very different from what they expected, anxiety about spending the money they’ve saved for decades, and decisions that can affect a spouse’s benefits for years to come.
    • “On this episode of Fed Thread [which the article summarizes], we called back our three financial professionals—James Campbell of Federal Employees Benefit Association, Katelyn Murray of RJFS and Serving Those Who Serve, and Chris Campbell of CJC Wealth Management and the DC Society for Financial Awareness—to talk through the financial and psychological traps feds may encounter before or after their last day. Because retirement isn’t just the day your paycheck stops. It’s the beginning of a completely different financial system.”

From the Food and Drug Administration front,

  • The Washington Post informs us,
    • “About 1.5 million dozen white and brown cage-free eggs recalled for potential salmonella contamination have been upgraded to the U.S. Food and Drug Administration’s highest-risk warning. 
    • “The agency reclassified the recall of Midwest Poultry Services eggs to Class I due to the reasonable possibility that exposure to the product would cause serious health issues or death, it said in a safety alert. 
    • “Salmonella is a bacteria that can cause diarrhea, vomiting, fever and stomach pain.
    • “The eggs were available to consumers in Brookshire Grocery stores in Texas, Louisiana, Oklahoma, Arkansas, New Mexico and Mississippi. Other locations include Kroger stores in Texas and Louisiana, as well as other small retail outlets, the FDA said.”
  • The UPI reports,
    • “U.S. health officials said they have begun inspections at the Mexican processing plant of the U.S. food distributor Taylor Farms as they deal with a continuing cyclosporiasis outbreak that has spread across 17 states.
    • “The Food and Drug Administration and the Centers for Disease Control and Prevention announced Thursday they have “initiated an onsite inspection and sampling” at Taylor Farms de Mexico’s facility in Guanajuato, Mexico, located about 185 miles northwest of Mexico City.”
  • The University of Minnesota’s CIDRA adds,
    • “The best-if-used-by dates of recalled iceberg lettuce associated with the massive Cyclospora outbreak have passed, according to an update from the US Food and Drug Administration (FDA) yesterday. This means that Cyclospora-tainted Taylor Farms lettuce should no longer be available at stores and restaurants.” 
  • Radiology Business relates,
    • “The U.S. Food and Drug Administration has approved a new brain imaging agent targeted toward Alzheimer’s, drugmaker Lantheus announced Friday. 
    • “Tauklarify, also known as MK-6240, is a radiodiagnostic agent indicated for PET (positron emission tomography) imaging of adults. Ideal candidates have cognitive impairment, with physicians evaluating them for abnormal buildup of tau—twisted, insoluble protein fibers in brain cells—a potential sign of the neurodegenerative disease. 
    • “Bedford, Massachusetts-based Lantheus—which recently reached a deal to be sold to rival Curius for $8 billion—said the drug’s safety was tested in two clinical trials. Across over 1,700 subjects, researchers reported strong results, with only about less than 1% of subjects experiencing adverse reactions.”

No Surprises Act News

  • The Centers for Medicare and Medicaid Service posted a notice today (Dropbox link) about implementation of changes to the Independent Dispute Resolution Gateway required by a recent final rule.
    • “Organizations and individuals thatprocess disputes, represent parties, or submit IDR web forms in the current Federal IDR process must sign up to manage disputes in the IDR Gateway. If a party uses a third-party administrator or another organization to process disputes, the party does notneed to sign up for the IDR Gateway but must ensure the third-party administrator or organization responsible for managing dispute processing activities signs up for an IDR Gateway account.
    • “Details about signing up for the IDR Gateway are coming soon. Until then, continue using the Federal IDR web.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “Luigi Mangione, whose coldblooded killing of an insurance executive on a Manhattan sidewalk rattled the nation and struck fear into Corporate America, pleaded guilty Friday to two federal stalking charges in the death of UnitedHealthcare leader Brian Thompson.
    • “On the morning of Dec. 4, 2024, I shot Mr. Thompson in Manhattan and he died,” Mangione solemnly told the judge during a court hearing.
    • “Mangione, wearing tan jail garb, told the judge that he spent years enduring severe pain, including a broken back, and witnessed others with similar experiences. He said that after learning of an investor conference, he emailed UnitedHealthcare, posing as an investor at a firm managing over $50 million in assets, to request information about it.
    • “Unlike my previous interactions with insurers, I received an immediate response within an hour,” Mangione added. He said he made part of a gun using a 3-D printer and planned the killing.
    • “U.S. District Judge Margaret Garnett said Mangione faces up to life in prison at his sentencing, which she set for December. Jamie McDonald, the U.S. attorney for the Southern District of New York, said after Friday’s hearing that his office intended to seek the maximum penalty, saying Mangione committed the crime in order to “draw public attention to his dislike of certain businesses.” 
    • “No grievance, political belief or ideological cause can ever justify murder,” McDonald said. “There can be no celebrity in assassination.”
  • FEHBlog observation: Well put observation, Mr. McDonald.
  • Healthcare Dive tells us,
    • “A patient advocacy group is going up against the most powerful doctor’s association in the U.S. in a bid to wrest away its ownership of U.S. medical codes and release them into the public domain.
    • “On Thursday, PatientRightsAdvocate.org sued the American Medical Association, challenging its copyright over the current procedural terminology, or CPT, billing code system, which shapes billions of dollars in healthcare payments every year.
    • “The goal of the lawsuit is to get the codes published online and let the public access them for free, the group, which lobbies for better price transparency in healthcare, said. Currently, the AMA charges licensing fees to retrieve and use CPT codes.”
  • FEHBlog observation — It’s no problem looking up CPT Codes on the internet.

From the public healh and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 14, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Based on multiple data sources, COVID-19 activity is low in many regions but is increasing in the West and South.
    • “RSV activity is very low in most areas of the country.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 101 newly confirmed measles cases nationwide, the US total has now reached 2,566 this year, the Centers for Disease Control and Prevention (CDC) said today in its weekly update.
    • “This is the second straight week of about 100 new cases after previous weeks’ totals of about half that. Most this week’s cases are in Pennsylvania, though Ohio also saw a substantial increase. 
    • “The CDC noted 38 outbreaks, the same as last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level several weeks ago. 
    • “All but 16 of this year’s cases have been locally acquired, with the rest tied to international travel.
    • “Of the 2026 cases, 19% involve children age 5 and under, and 67% involve kids and teens. Seven percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status.”
  • and
    • “A pair of new studies confirm that recently developed immunizations against respiratory syncytial virus (RSV) protect infants in their first year of life. 
    • “The research, including one study conducted in France and another in the United Kingdom, confirm that the immunizations are effective in the real world, not just in carefully supervised clinical trials”
  • MedPage Today relates,
    • “By this time of year, both the FDA and CDC normally have weighed in on fall respiratory virus vaccine recommendations. But given ongoing controversies over vaccination spurred by the Trump administration, a wrench has once again been thrown into the gears of that process.
    • “The FDA has done its part, making recommendations about vaccine composition for influenza vaccines in March, followed by recommendations for COVID shots in May. But the CDC’s Advisory Committee on Immunization Practices (ACIP) hasn’t done its part as it hasn’t held its March or June meetings this year.” * * *
    • But clinicians shouldn’t worry, because medical groups have stepped in to fill the gaps. The IDSA, the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians (AAFP) have issued guidance on fall respiratory virus shots and more, as the Trump administration has also tried to make significant changes to the pediatric immunization schedule.
    • At the same time, insurers have pledged to cover all recommended vaccines without cost-sharing through the end of 2027, Richard Hughes IV, MPH, legal counsel for AAP, said in an email in June.
    • “There are some shades of gray, however, as the FDA approved the first mRNA flu shot (mFlusiva) from Moderna earlier this month. While the company has said its shot — approved for adults 50 and up — should be available for the upcoming 2026-2027 season, it’s unclear whether it will be written into recommendations.”
  • and
    • “GLP-1 agonists and bariatric surgery are top obesity treatments, raising questions of their combined efficacy.
    • “A retrospective study found that patients taking GLP-1 drugs before surgery achieved similar 12-month weight loss as non-users (24% vs 25%).
    • “Treatment groups had comparable outcomes on surgical complications and diabetes control.”
  • Health Exec informs us,
    • “Right now U.S. healthcare has almost everything it needs to eliminate one awful affliction—and then to adapt the resulting victory for going after many others.  
    • “All it would take to set the precedent is responsible AI deployment, attuned government leadership, cross-sector partnerships and generational investments.  
    • “That, and an orchestrated targeting of the low-hanging fruit at hand—cervical cancer.  
    • “The cure-in-waiting for this maddeningly preventable cancer represents a “breakthrough with a failure to follow through,” physician-researchers explain in an article published Aug. 13 in JAMA.  
    • “Erstwhile Surgeon General Special Advisor Adam Beckman, MD, MBA, and co-author Dave Chokshi, MD, MSc, believe cervical cancer is a prime candidate for first dibs because of its 90%-plus early-stage survival rate on top of the near-perfect efficacy of vaccines for human papillomavirus (HPV), which causes many if not most cervical cancers. 
    • “All that’s lacking is the will to “bridge the stubborn gap between what we know and what we do in public health and healthcare,” the researchers write.”
  • Health Day points out,
    • “Taking the stairs instead of the elevator may do more for your health than you think.
    • “A large study published in the American Journal of Cardiovascular Drugs found people who regularly climbed the stairs were 39% less likely to die from cardiovascular disease. And 24% less likely to die from any cause. Their odds of heart attack, stroke and heart failure were also lower.
    • “Taking the stairs is a practical and often overlooked way to build physical activity into daily life,” said senior author Dr. Vassilios Vassiliou, a professor of cardiac medicine at Norwich Medical School at the University of East Anglia in the U.K. “We wanted to better understand how this everyday activity could have life-saving potential.”
  • and
    • “Gambling is a powerful temptation for today’s college students, and those hooked have a greater risk of deeper mental health issues, a new study says.
    • “Student gambling frequently occurs alongside depression, anxiety and substance use, researchers reported recently in the International Journal of Mental Health and Addiction.
    • “What’s interesting about this study is even though mental health concerns were very prominent, students who tended to gamble more were more likely to be experiencing greater levels of problems among a sample that was already experiencing plenty,” said lead researcher Nicholas McAfee, director of the William Magee Center for AOD and Wellness Education at the University of Mississippi.
    • “Gambling is a real concern for college students, given the proliferation of online betting and prediction markets in the United States, researchers said in background notes.”

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

  • The International Foundation of Employee Benefit Plans reports,
    • “U.S. employers project a median health care cost increase of 10% for 2027, according to Health Care Costs Pulse Survey: 2027 Cost Trend, a new survey from the International Foundation of Employee Benefit Plans. A similar International Foundation survey conducted in 2025 also projected a 10% increase for 2026.” 
  • Healthcare Dive adds,
    • “Nearly 4 in 5 U.S. adults said either high insurance premiums or out-of-pocket spending were the most important problem in the healthcare system, according to a Commonwealth Fund survey released Thursday. 
    • “Affordability concerns crossed party and coverage lines. Premiums were the top problem for 45% of Republicans, 44% of Democrats and 42% of independents, while more than 8 in 10 adults with employer, individual or marketplace coverage — as well as uninsured adults — said either premiums or out-of-pocket costs were the biggest issue.
    • “Still, according to the survey, Americans are split over who’s best to tackle the problem. Most respondents said the federal government is best suited to solve high healthcare prices, while Republicans were more likely to say insurance companies were best to address the issue.”
  • FEHBlog observation — Consumers pay insurance premiums and cost sharing but evidently fail to understand that those costs are driven by hospital, doctors and pharmacy charges.
  • In that regards, The Washington Post relates,
    • Prescription drug prices recorded the biggest year-over-year drop in more than 60 years in July, a startling reduction experts chalked up to an array of factors, including more generics and discount GLP-1 weight-loss drugs. 
    • While overall costs for medical services continued to rise, prices for medicinal drugs fell 2.7 percent over the 12 months ending in July, the largest annual drop on record, according to Bureau of Labor Statistics data released Wednesday. Prescription drugs, part of the medicinal drug category, fell by 3.1 percent, the steepest annual decline since March 1963.
  • EBRI calls to our attention,
    • “Plan sponsors that wish to introduce or continue offering health savings account (HSA)-eligible health plans as part of their workplace benefit program can benefit from a long-term view of HSA accountholder behaviors. As such, the Employee Benefit Research Institute (EBRI) has undertaken a series of longitudinal studies from its HSA Database, examining trends in account balances, individual and employer contributions, distributions, invested assets, and account-owner characteristics from 2011‒2024. Such analysis can help plan sponsors, providers, and policymakers better understand strategies that can help improve employee financial wellness.”
    • “HSAs offer a triple tax advantage to accountholders, enabling them to stretch money they save for health care expenses further than they otherwise could. The tax benefits of HSAs are maximized when accountholders contribute the statutory maximum and minimize withdrawals for current medical expenditures — if they are able — and invest their HSA balances in assets other than cash. However, the majority of accountholders appear to use their HSAs to pay for current expenses and do not take complete advantage of the tax benefits HSAs offer. Average contributions are well below the statutory maximum, most accountholders take a distribution from their HSA, and relatively few accountholders invest. We do find that as time goes on, accountholders tend to take fuller advantage of the benefits HSAs offer. And, despite out-of-pocket spending on health care rising by 5.9 percent in 2024, average balances in HSAs increased, rising from $4,747 in the prior year to $5,532. Further, the share of accountholders who invest their HSAs has crept steadily upward since EBRI began analyzing its HSA Database, reaching 18 percent in 2024.”
  • Beckers Hospital Review tells us,
    • “Providence Health Plan will completely shut down after it was unable to reach a deal with a national insurer to operate its Medicare Advantage business.
    • “We are in discussion with regulators about this development and the broader wind-down of Providence’s health plan operations,” a spokesperson for the system told Becker’s. “We will share more details with our members and the public as we are able under applicable regulations.”
    • “In May, the Renton, Wash.-based health system said it would shutter most of its insurance business beginning in 2027 after operating more than 40 years as a regional payer and serving more than 440,000 members. 
    • “At the time, President and CEO Erik Wexler said state and federal regulations and consolidation among large insurers had left Providence “in an untenable situation” and unable to continue operating the health plan.”
  • and
    • “Cleveland Clinic recorded operating income of $245.6 million (5% operating margin) during the second quarter of 2026, down from operating income of $255.3 million (5.6% margin) during the same period last year, according to its Aug. 14 financial report.”
  • and
    • “New Orleans-based Ochsner Health recorded operating income of $32.5 million (0.8% operating margin) in the first half of 2026, up from an operating loss of $42.7 million (-1.1% margin) during the same period last year, according to its Aug. 13 financial report.” 
  • Beckers Physician Leadership points out,
    • “Hollywood, Fla.-based DermCare Management and Dallas-based U.S. Dermatology Partners have partnered to form one of the largest dermatology groups in the U.S. 
    • “The combined company will expand patient access, preserve physician autonomy, support national dermatology clinical trials, improve practice management support and unify culture, according to an Aug. 13 news release from DermCare Management. 
    • “DermCare Management partners with more than 270 dermatology practices, and U.S. Dermatology Partners supports a network of more than 120 locations across nine states.” 

Thursday report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Service news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced $102 million in New Access Points awards to significantly expand the reach of the Health Center Program. The awards represent the first major expansion of the Health Center Program since the first Trump Administration in 2019, supporting 158 new and existing health centers to establish 415 new sites and expand access to comprehensive primary care for nearly 1 million people nationwide.
    • “Strong primary care prevents disease and gives Americans greater control over their health,” said HHS Secretary Robert F. Kennedy, Jr. “This $102 million investment will bring high-quality care to nearly one million more Americans, expand prevention and nutrition services, and help communities tackle chronic disease at its roots. We are giving more Americans the tools to live healthier lives and Make America Healthy Again.”
    • “Learn more about the Health Center Program and find a health center near you.
    • “Visit the New Access Points webpage for more details on the program and a list of 2026 award recipients.”
  • Per a Government Accountability Office news release about a new report,
    • “National Crisis and Support Hotlines: Contact Volume Increased and Operations Remained Relatively Consistent in 2025
    • “GAO-26-109046. Published: Aug 13, 2026
    • “The federal government operates the following hotlines:
      • “Health and Human Services’ 988 Suicide & Crisis Lifeline provides 24/7 support to people in distress
      • “HHS’s National Maternal Mental Health Hotline provides emotional support to pregnant and postpartum women
      • “Veterans Affairs’ Veterans Crisis Line provides support to veterans, service members, and their families
    • In February 2025, the President issued an executive order aimed at reducing the size of the federal workforce. While HHS and VA reduced their staff, the hotlines’ operations and services remained mostly consistent, with an increase in chats, texts, and calls.
  • FEHBlog observation: While aware of the 988 line, he wants to call attention to the other two lines.

From the U.S. Office of Personnel Management front,

  • Federal News Network reports about, “FEHB and Medicare: Understanding how they work together in retirement.”
  • Fedweek explains “How FEDVIP Differs from FEHB in Retirement.”
  • Tammy Flanagan, writing in Govexec, advises “Before you take money out of your TSP, weigh these trade-offs.”
    • “A withdrawal can affect everything from your tax bill and Medicare premiums to how long your savings last and what your heirs receive.”
  • Federal News Network tells us,
    • “Following a year of sweeping staffing reductions, the Trump administration is laying the groundwork for agencies to ramp up recruitment efforts. The Office of Personnel Management has directed agencies to begin assembling “annual staffing plans” for fiscal 2027.”
  • Chief Data Officer Magazine informs us,
    • “The U.S. Office of Personnel Management (OPM) has directed federal agencies to make technology recruitment a key component of their fiscal year 2027 workforce plans. Guidance issued by OPM directs agencies to include dedicated hiring strategies for roles in artificial intelligence (AI), cybersecurity, software engineering, data science, digital services, and other technology fields in staffing plans due by Sept. 30.
    • “Agencies are also expected to assess how the adoption of modern technologies will affect workforce needs and align hiring accordingly.”
  • Federal News Network adds,
    • “The Merit Systems Protection Board is officially transitioning away some of its authority over adverse action appeal decisions. A new final rule from MSPB removes all references to the board’s prior jurisdiction over appeals due to firings or demotions during a reduction in force, probationary period or for a suitability-related reason. The adjustments at MSPB come after the Office of Personnel Management finalized rules to take over decisions in those three categories of workplace disputes. The change takes full effect in early September.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports.
    • “Novartis is recalling a single lot of valsartan, a blood pressure drug the company sells under the brand name Diovan, due to failed dissolution specifications. This means it is not dissolving correctly, which can impact the drug’s effectiveness. 
    • “The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, meaning exposure to the drug may lead to “temporary or medically reversible adverse health consequences.” 
    • “Diovan is an angiotensin II receptor blocker used to treat hypertension and heart failure. It may also be prescribed to patients after a heart attack. This specific lot, AV5913C, includes packages of 90 160-mg tablets that expire in June 2027. The drugs were manufactured by Pantheon Manufacturing Services in Greenville, North Carolina, and distributed by Novartis Pharmaceutical Corp. in Hanover, New Jersey.”
  • Yahoo News relates,
    • “There’s an ongoing recall on a specific type of bladder medication distributed and prescribed nationwide, according to the U.S. Food and Drug Administration (FDA). This is due to an impurity issue.
    • “The medication being recalled is 25-milligram, 30-count bottles of mirabegron extended-release tablets manufactured by Zydus Lifesciences. The recalled bottles contain a lot code of “E408618,” an NDC of “70710-1159-3” and the expiration date “11/30/2026.” * * *
    • “Check your medication, and if you have the recalled product on hand, contact your pharmacy for a refund or replacement. Seek medical attention if you are experiencing any health concerns after consuming the affected pills.”
  • Reuters tells us,
    • “The U.S. FDA on Thursday approved Bristol Myers Squibb’s (BMY.N) oral combination treatment for patients ​with a rare form of blood cancer whose illness had relapsed or ‌not responded to other treatments, the health regulator said.
    • “The drug, iberdomide, with brand name Zenbexus, is given in combination with J&J’s (JNJ.N), opens new tab Darzalex and dexamethasone, a prescription medication used to reduce inflammation.” * * *
    • “The list price of Zenbexus is $29,500 ‌for ⁠a 28-day cycle, Bristol said. The company expects product availability within the coming weeks.”
  • The American Hospital Association News adds,
    • “The AHA Aug. 13 responded to a Food and Drug Administration request for input on the risks and benefits to health and safety associated with non-device software. Among its recommendations, the AHA supported the benefits of clinical decision support software and requested the FDA to permanently adopt flexibilities for CDS that generate only one clinical recommendation. The AHA also requested that the FDA clarify its general wellness guidance by providing additional resources on labeling and clarifying or removing references to allow non-device general wellness applications to make recommendations on escalation to a healthcare provider. Finally, the AHA encouraged the FDA to continue to update guidance, education and other materials to account for novel artificial intelligence applications, including generative AI. Input will support an agency report, as required under Section 3060 of the 21st Century Cures Act.”

No Surprises Act News

  • Following up on yesterday’s discussion of the U.S. Court of Appeals for the Fifth Circuit’s opinion about the calculation of qualifying payment amounts (“QPA”), the American Hospital Association tells us,
    • “A statement posted Aug. 13 on the Centers for Medicare & Medicaid Services website said that the agencies are reviewing the court’s opinion and judgement and anticipates issuing guidance shortly.” 
  • FEHBlog Observation: The Fifth Circuit is a victory for the majority of health care providers who accept the QPAs. No one can object to that outcome.
  • Beckers Hospital Review recounts “the never-ending No Surprises saga.”
    • “When President Trump signed the No Surprises Act into law in 2020, the straightforward premise was that patients should not be blindsided by massive emergency care bills from out-of-network physicians they never chose. On that front, the law has largely worked. 
    • “But the system Congress built to resolve payment disputes between insurers and providers has led to an increasingly expensive and bitter standoff that insurers say is driving up premiums, while physicians report waiting months to get paid. And employers, particularly the self-funded plans that cover the majority of commercially insured workers, say they’re the ones now stuck with a big chunk of the bill. In recent months, the courts, Congress and federal regulators have all been moving in different directions on exactly what to do about it.”

From the judicial front,

  • Beckers Hospital Review reports,
    • “The federal government has referred dozens of hospitals, pharmacy benefit managers and pharmacies to investigators over potentially fraudulent billing related to pediatric gender-affirming care.
    • “Vice President JD Vance referred hospitals and clinics identified in a new HHS report to the Justice Department, while HHS Secretary Robert F. Kennedy Jr. referred flagged organizations to HHS’ Office of Inspector General over “potentially anomalous billing patterns” identified through an analysis of insurance claims, according to an Aug. 13 news release.” * * *
    • “In the report, HHS shared its analysis of claims data spanning 2015 to 2025, identifying $47.6 million in claims for puberty-blocking drugs prescribed to patients 9 to 17 years old with endocrine disorder diagnoses, excluding precocious puberty. The patients also did not have a gender-related diagnosis documented. Of those claims, $42.6 million stemmed from an unspecified endocrine disorder diagnosis, the report said.” * * *
    • “The referrals mark the latest escalation in a federal crackdown on pediatric gender-affirming care that began shortly after President Donald Trump returned to office in January 2025. Some pediatric hospitals, most recently Hartford-based Connecticut Children’s Medical Center, have struck deals with the Justice Department and stopped providing gender-affirming care services.”
       
  • The Wall Street Journal relates,
    • “Luigi Mangione is expected to plead guilty Friday in a Manhattan federal court, where he is facing stalking charges in connection with the killing of UnitedHealthcare CEO Brian Thompson outside a Midtown hotel in 2024, people familiar with the matter said.
    • “The expected plea potentially resolves the federal case just a month before Mangione is scheduled to go to trial in New York state court on murder and other charges. But the people familiar with the matter cautioned that Mangione still could change his mind. And his defense team has abruptly shifted strategies previously.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Arthritis in its many manifestations is among the most common chronic conditions, affecting some 53 million adult Americans, and its associated pain often impairs the ability to perform daily activities including work.
    • “The Healthy People 2030 initiative set a goal of reducing the prevalence of joint pain in the U.S. to about 52%.
    • “In this analysis of National Health Interview Survey data from 2023, moderate to severe joint pain was reported by 58% of those with arthritis, with no change from 2019 (57%) after adjusting for age distribution.”
  • and
    • “Estrogen-only menopausal hormone therapy was linked with reduced Alzheimer’s pathology in an autopsy study.
    • “Estrogen treatment was also tied to lower odds of dementia diagnosis.
    • “More than 20 years after the landmark Women’s Health Initiative trial, hormone replacement therapy remains controversial.”
  • Beckers Behavioral Health relates,
    • “A nationwide, evidence-based tobacco treatment program for cancer patients and survivors in the U.S. would save $12.32 billion in healthcare costs over 10 years, according to a study published July 14 in JCO Oncology Practice.
    • “Led by researchers from Houston-based University of Texas MD Anderson Cancer Center, the study projected 10-year survival trends and healthcare cost savings associated with a nationwide smoking cessation program targeted to 18 million U.S. cancer survivors.” * * *
    • “Read the full study here.” 
  • Healio adds,
    • “Exercise capacity, oxygen uptake and ventilation at peak exercise were significantly reduced in e-cigarette and conventional cigarette users vs. never smokers.
    • “Vascular function also followed this pattern.”
  • BioPharma Dive lets us know,
    • “Taiho Oncology and partner Cullinan Therapeutics said a targeted medicine they’re developing has succeeded in a Phase 3 trial in frontline lung cancer, with investigators halting the study at an early data check because of clearly positive results.
    • “Taiho and Cullinan have been testing that therapy, zipalertinib, alongside chemotherapy in the first-line setting in people whose lung tumors have a so-called exon 20 insertion in a gene called EGFR. They didn’t release detailed data, but on Wednesday said that the combination “demonstrated a statistically significant and clinically meaningful improvement” in progression-free survival, meeting a pre-planned threshold for unblinding the trial.
    • “The Food and Drug Administration is already reviewing zipalertinib as a second-line treatment and is expected to make a decision by Feb. 27. If approved, the drug will add to an already competitive market battle. Johnson & Johnson’s Rybrevant and AstraZeneca and Dizal’s Zegfrovy are both available, and another biotechnology company, ArriVent BioPharma, is expecting Phase 3 data later this year.”
  • and
    • “Boulevard Bio, a new startup co-founded by pioneering autoimmune disease researcher Georg Schett, officially launched Wednesday with $65 million in its coffers and three experimental drugs.
    • “One of those medicines is already in early testing. Called BLVD-101, that drug is a so-called bispecific antibody aimed at a pair of targets known to drive the progressive kidney condition IgA nephropathy.
    • “IgAN has become a popular target for drugmakers of late. In the last year, U.S. regulators have approved two drugs, Vera Therapeutics’ Trutakna and Otsuka Pharmaceutical’s Voyxact. A third from Vertex Pharmaceuticals could follow.”
  • Fierce Pharma notes,
    • “Roughly a year and a half after the approval of Vykat XR, a group of clinicians with deep ties to the Prader-Willi syndrome (PWS) community is flagging potential safety concerns about the rare disease med, acquired in Neurocrine’s $2.9 billion buyout of Soleno Therapeutics last spring.
    • “The package insert for Vykat XR (diazoxide choline)—a potassium channel activator that became the first drug approved to treat the sensation of insatiable hunger, or hyperphagia, in PWS in March 2025—already cites the risk of fluid overload, based on an increased incidence of edema seen during clinical trials. 
    • “Since becoming more widely available, additional reports of edema and related complications in patients taking Vykat XR have been posted to the FDA’s Adverse Event Monitoring System (AEMS), including seven reports of death and more than 100 other reports of serious adverse events, mostly tied to edema, respiratory and cardiac complications.
    • “The adverse event trend, which doesn’t establish that Vykat XR caused the events, was flagged in a statement (PDF) from PWS patient organizations the Foundation for Prader-Willi Research, the International Prader-Willi Syndrome Organization and Prader-Willi Syndrome USA. The issue was first reported by Stat News earlier on Wednesday.” 

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

  • The American Hospital Association News reports,
    • “A blog by Robyn Tessin, AHA director of policy, discusses the ways value-based care can meet patients’ needs, resulting in improved affordability and access to timely, coordinated care. “The promise of value-based care is a healthcare system that feels less like a collection of separate transactions and more like a connected journey centered on each patient,” Tessin writes. “No single payment model can solve every affordability challenge. But providers, policymakers, payers and patients can build on what is working — strengthening existing models such as [accountable care organizations], scaling innovations in care coordination and ensuring that the models’ financial incentives are meaningful for patients.” READ MORE 
  • Beckers Payer Issues adds,
    • “Mishawaka, Ind.-based Franciscan Alliance has partnered with Millennium Physician Group to expand value-based care and primary care access across Indiana.
    • “Fort Myers, Fla.-based Millennium is part of a national value-based care platform partially owned by Elevance Health.
    • “The partnership will combine Franciscan’s physician network with Millennium’s practice management, analytics and value-based care capabilities. Franciscan physicians will remain part of the health system’s physician network while gaining access to additional operational support, technology, care coordination resources and analytics.
    • “As Franciscan Alliance celebrates 150 years of serving Indiana, this partnership represents the next chapter in that mission,” Franciscan Alliance President and CEO Kevin Leahy said in an Aug. 12 news release. “By combining our trusted community presence with Millennium’s proven expertise in value-based care, we are strengthening our ability to expand access, enhance quality and deliver more affordable healthcare for generations to come.
    • “The organizations said the partnership is designed to reduce administrative burdens for physicians, improve clinical performance and strengthen chronic disease management and care coordination.”
  • Reuters relates,
    • “Novo Nordisk (NOVOb.CO) CEO Mike Doustdar said investors are underestimating the demand for differentiation among obesity drugs, ‌and that new treatment options like pills will keep it from becoming a winner-take-all battle with rival Eli Lilly.
    • “Novo was first to bring a highly effective GLP-1 weight-loss injection, Wegovy, to the U.S. market, but is under pressure to regain ground lost to Lilly’s (LLY.N) Zepbound in a business that ​analysts expect will be worth more than $100 billion a year by 2030.
    • “Doustdar, who took the helm at the Danish ​drugmaker a year ago, said that patients are just beginning to understand which GLP-1 drug is ⁠best suited to them, and he expects more segmentation as new medicines are approved. More than 100 million U.S. adults ​are classified as obese.
    • “Right now the investor community has thought this is supposed to be a zero-sum game between two players – ​there’s a loser and a winner,” Doustdar said in an interview with Reuters on Wednesday.
    • “As you foresee the future of GLP-1s and obesity and weight-loss drugs, it will not be Coke versus Pepsi. It will be Coke and Pepsi and Fanta and Dr Pepper and Red Bull. People are ​thirsty, and they can make their choices,” he said.”
  • Beckers ASC Review tells us,
    • “For much of the past decade, the story of physicians’ practice has moved decidedly away from independence. 
    • “Hospital and corporate employment of physicians climbed from 62% to 78% between 2019 and 2023, and private practice fell from 60% of physicians in 2012 to just 42% in 2024, according to data from the Government Accountability Office.
    • “But 2026 is producing early signs that the pendulum may be swinging back, not toward the traditional solo practitioner model, but toward a new one built around management services organizations, physician practice networks and other arrangements designed to help physicians reclaim ownership and autonomy without giving up the scale and capital that made employment attractive in the first place.”
  • Healthcare Dive informs us,
    • “Nonprofit hospitals and health systems rated by credit ratings agency Fitch raised their operating margins and extended their financial recovery last year, according to a Fitch Ratings report based on audited fiscal 2025 data.
    • “The median operating margin among 222 nonprofit providers rose to 1.5%, compared to 1.1% in 2024, according to the report, and gains were increasingly concentrated among more financially stable providers. 
    • “Still, Fitch warned that 2025 could prove to be an “operational peak” before Medicaid funding reductions and other policy changes begin to pressure hospital revenue more significantly in 2027. Financially unstable and Medicaid-dependent providers have less financial cushion to absorb the coming strain, according to the credit ratings agency.”
  • Fierce Healthcare points out,
    • “Aetna is seeing its value-based care efforts pay off in both preventive care metrics and cost savings, according to a new analysis from the company.
    • “The insurer compared (PDF) outcomes across 20 different measures for individuals in its Medicare Advantage plans between value-based models and fee-for-service, and found that the value-based arrangements supported better results across 17 of the included measures.
    • “For example, value-based care models far outpaced fee-for-service in managing blood sugar and high blood pressure. Under value-based care, 43% more members controlled their HbA1C and 34% had controlled blood pressure, according to the analysis.
    • “In addition, 20% more patients were screened for colorectal cancer under value-based care and there were 7% fewer hospitalizations. These providers also generated $315 million in savings during plan year 2023, 2.6% higher than fee-for-service providers.”
  • and
    • “Cedar, a patient financial platform for healthcare providers, launched an agentic artificial intelligence platform Thursday aimed at patient medical billing.
    • “Kora Platform is a suite of purpose-built AI agents that integrates with healthcare organizations’ existing electronic health records (EHRs), telephony and call center systems. Some of the capabilities included within the suite include autonomous inbound voice, autonomous outbound voice, two-way text and advanced reporting.
    • “We really want Kora Platform to be this agentic advocate that’s sitting in the pocket of every patient,” Cedar Chief Strategy Officer Dugan Winkie told Fierce Healthcare.”
  • The American Medical Association lets us know about “four AI prompts to help prepare for your doctor’s appointment.”
    • “Here are some top expert tips on how to use AI chatbots in a way that makes the most of your time in the exam room with your physician.”

Weekend update

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “The Senate easily passed a bipartisan continuing resolution early Saturday morning, likely easing the traditional September rush to head off a partial government shutdown in October.
    • “On a lopsided vote of 90-6, the Senate passed a measure that would extend current funding through Dec. 11, giving lawmakers about 10 extra weeks to complete full-year appropriations bills for fiscal 2027.
    • “But the bill still requires a vote in the House, which won’t be back in session until the first week of September. The House had passed a more bare-bones funding extension last month without many of the “anomalies,” or deviations in current spending, requested by the Trump administration.”
  • Bloomberg Law adds,
    • The US Senate confirmed Todd Blanche as attorney general, elevating President Donald Trump’s one-time personal defense lawyer to lead the nation’s top federal law enforcement agency.
    • Republicans closed ranks and supported Blanche, 52, in a 50-49 vote even after two GOP senators joined Democrats in opposition. Republican Senator Bill Cassidy of Louisiana, one of the holdouts, came out in support of Blanche after Senators Susan Collins of Maine and Lisa Murkowski of Alaska voted against him. 
  • The House of Representative and the Senate are now on District / State work breaks until August 31 for the House and September 14 for the Senate.

From the U.S. Office of Personnel Management front,

  • Kevin Moss, in an interview with Federal News Network, explains why “Retirement [from the federal goverment or the Postal Service] doesn’t make your health benefits simpler. It makes them more complicated.

From the public health and medical / Rx research front,

  • The American Medical Association points out,
    • “The measles vaccine is given as part of the measles, mumps and rubella vaccine, so we call it MMR. It’s also given as part of MMRV, which adds in varicella for chickenpox,” Dr. Land said, noting “It’s typically given to child at age 1.”
    • “We give it at 12 months, but it can be given at 12 or 15 months—it can be given as either MMR or MMRV—and then again at 4 to 5 years old,” she said, emphasizing “the measles vaccine is probably the most successful vaccine that we have.”
    • “If you’ve had both of your vaccinations, you are 97% immune for life,” Dr. Land said. “If you have just one dose, you’re 93% and that is incredible protection.”
    • “For adults who do not have immunity or have not received vaccination, “one dose is typically enough,” Dr. Kaufman West said. “But depending on your medical history and what’s going on with you, it’s a good idea to talk to your physician and see if there would be any changes to that.”
  • CBS News reports,
    • “Federal officials on Saturday issued a public health alert for meat products containing jalapeños that may be linked to a salmonella outbreak that has sickened hundreds of people across at least 27 states. 
    • “The U.S. Department of Agriculture’s Food Safety and Inspection Service, or FSIS, said the alert applied to red meat and poultry products containing jalapeños that may be contaminated with salmonella. 
    • “The USDA said that it learned of the issue when it discovered that multiple establishments that are regulated by FSIS had received a recalled ingredient. 
    • “It released a list of 18 recalled products that are impacted by the alert. Those included the brands Taylor Farms, Ready Meals, Meal Simple, Higher Harvest and Deli Kitchen. 
    • “The agency said in a statement that it “expects additional downstream products will be identified as this ingredient recall progresses.”
  • The Washington Post relates,
    • “Cyclospora and other parasites can survive sewage treatment in small quantities, and crops are sometimes irrigated with treated water.
    • “That’s why scientific researchers and public health officials are pointing to sewage contamination in the food supply as one of the most plausible theories for the current U.S. cyclospora outbreak. The government says it is still investigating the cause.
    • “The parasite’s spread can become a self-perpetuating cycle. Cyclospora is found only in humans, where it replicates in the intestinal tract, causing severe diarrhea. The organism reproduces by releasing oocysts, which are excreted in those human feces. In the United States, feces usually end up in sewage systems.
    • “In many states, sewage water is treated — though not always in ways that remove or kill the oocysts — and then released into waterways that can be used to irrigate crops. The oocysts mature in the environment with warm temperatures in about a week. Then a human comes along and eats the irrigated food or drinks the water and gets sick, releasing more oocysts into sewage systems.”
  • The FEHBlog asked Claude AI about the last paragraph. Here is his response:
    • “[T]he Post’s “many states” is best read as a general characterization — sewage discharge into surface waters is a nationwide Clean Water Act practice — but the specific research documenting the produce-safety risk concentrates on four states: Arizona, Texas, Georgia, and Florida/California.”
  • Healio tells us,
    • “A pivotal trial is now underway for i-Lumen AMD, a bioelectric therapy being investigated for intermediate to advanced dry age-related macular degeneration, according to a press release from i-Lumen Scientific.
    • “The noninvasive, office-based therapy applies low-level microcurrent stimulation via the closed eyelid, which may improve photoreceptor cell function by repolarizing retinal pigment epithelium cells, according to the company.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “More than a million times a year, a U.S. surgeon slices open a knee, strips out worn cartilage, caps the leg bones with metal and drops in a plastic spacer to allow the new joint to glide.
    • “But while these knee-replacement procedures have become standard, the prices charged have not.
    • “At Catawba Valley Medical Center in Hickory, North Carolina, for example, the cost of the procedure under a Blue Cross Blue Shield health plan this year was about $16,000, according to data from Serif Health, a San Francisco start-up that collects recently released data from hospitals and insurers. Little more than an hour’s drive east, however, at Mission Hospital in Asheville, the cost of the procedure under the same health plan was around $40,000, or more than double, the data showed.
    • “Formed by the merger of the two largest hospitals in the region, Mission has little competition and more power to demand the higher price.
    • “The comparison between these two hospitals illuminates how large hospital systems created by a wave of U.S. mergers in recent decades can dominate the competition and push up health care costs. 
    • “While many factors affect the price of a medical procedure, hospitals with few competitors can charge more, health economists say.” * * *
    • “Over time, anyone who pays for health insurance pays a price for hospital monopolies, as insurers boost premiums as medical costs rise. The full cost for an employer to pay for an average family health insurance plan rose to more than $27,000 in 2025, up from $21,000 just six years ago, according to figures from KFF.”
  • The American Medical Association adds,
    • “A report recently released by Resolve, a contract review and negotiation firm specializing in physician employment, draws on data from the thousands of physician contracts the firm handles to outline must-know trends nationally, as well as across regions, practice settings and more.
    • “The report shows that physicians’ base salaries grew roughly 2% to 4% per year, a growth rate down from years past, in which physicians were seeing increases of 5% to 6% per year. 
    • :And importantly, more of physician compensation comes in sign-on and retention bonuses than in past years, and it is increasingly tied to variable factors such as relative value units (RVUs), along with quality and other metrics.
    • “Physician compensation did not simply grow or shrink; it became more conditional,” the report’s authors noted.”