Friday report

COVID-19

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Services news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), today announced that it has awarded $247.9 million in grants to expand access to addiction treatment, mental health services, and recovery support in communities across the country. The investments will strengthen mental health support in schools, expand trauma treatment for children and families, equip first responders and communities to reverse overdoses, and help people in recovery return to work and rebuild their lives.
    • “HHS is investing nearly $250 million to put lifesaving treatment and recovery services directly into communities across America,” said HHS Secretary Robert F. Kennedy, Jr. “Through President Trump’s Great American Recovery, we are expanding addiction treatment, preventing fatal overdoses, helping children and families heal from trauma, and giving Americans in recovery the support they need to rebuild their lives. We are equipping communities with proven tools that save lives and help people recover.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is launching an initiative with a founding group of 37 state partners to focus on how quality is measured in Medicaid and the Children’s Health Insurance Program (CHIP). The effort will put health outcomes — not processes and paperwork — at the center of how success is defined. CMS and its partners will prioritize measures that demonstrate meaningful improvements in prevention, chronic disease management, and behavioral health.
    • “For too long, Medicaid has measured whether boxes are checked instead of whether patients are getting healthier — that must change,” said CMS Administrator Dr. Mehmet Oz. “We should judge success by what matters — preventing disease, managing chronic conditions, and improving patients’ health.”
    • “We are shifting the focus from paperwork and process to real accountability for what matters: health outcomes. We are encouraged at this level of commitment from states, and we are ready to get to work with them to implement this vision,” said CMS Deputy Administrator Stephanie Carlton.”
  • Fierce Healthcare reports,
    • “A new coalition is bringing together employers, clinicians and other stakeholders to push for the expansion of direct contracting.
    • “The Association for Direct Care will advocate for policies that ease barriers to direct contracting arrangements between employers and providers, boost transparency and support new payment models. A key goal, according to the announcement, is to support lower costs and better quality as well as the relationship between providers and their patients.
    • “The organization will focus on the expansion of direct employer contracting in the commercial space as well as in federal health programs.”
  • Healthcare Dive relates,
    • “A new report from a conservative think tank is accusing 340B hospitals of providing less charity care than other nonprofit hospitals, despite receiving discounted drugs.
    • “Hospitals participating in the 340B drug discount program spent 2.16% of their operating expenses on free or discounted care for low-income patients, called charity care, compared with 2.82% at non-340B hospitals, according to a Thursday analysis from the Pioneer Institute and CancerCare.
    • “Hospitals pushed back on the report, with the American Hospital Association saying 340B hospitals provide support for patients in other ways. “This report is another in a long line of misleading studies that wrongly singles out charity care as the only way to measure how hospitals provide for their patients and communities,” Bharath Krishnamurthy, director of pharmaceutical policy at the AHA, said in an email.”
  • Per MedTech Dive,
    • “Diagnostics companies, under pressure from proposed Medicare reimbursement cuts, are renewing calls for Congress to pass legislation that could provide relief by changing how data for setting laboratory test payment rates is collected.
    • “A new clinical laboratory fee schedule proposed this week by the Centers for Medicare and Medicaid Services would usher in the cuts beginning next year. Lab service providers face payment reductions of 15% on 775 tests under the preliminary schedule for 2027, according to the American Clinical Laboratory Association. 
    • “Getting legislation through Congress that would avert the reductions will be a tough task, however. The House of Representatives is now in recess until after the November midterm elections.”

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

  • OPM Director Scott Kupor writes (Substack link) in his Secrets of OPM blog about his efforts to recruit young people into federal service.
    • “My message to students has been really simple – we don’t need you to make a 40-year decision to be a federal employee. Instead, give it a shot for 2-3 years and see if you like it. I hope some will and may re-up for another stint, but for sure many will decide to seek their calling elsewhere. That’s fine; we don’t need to fight that or denigrate that. Any public service is better than none and getting a firsthand understanding of how government works will engender a sense of patriotism that we can’t replicate in any better way.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Eli Lilly received FDA approval Sept. 24 for Onswik, a once-weekly basal insulin injection for adults with Type 2 diabetes.
    • “The FDA approved Onswik for use alongside diet and exercise to improve glycemic control. The drug delivers steady basal insulin levels over seven days. Lilly said the drug is designed to eliminate more than 300 injections per year compared with once-daily basal insulin.”
    • “Onswik is not indicated for Type 1 diabetes because it raises the risk of severe hypoglycemia in those patients.
    • “Lilly plans to launch the Onswik KwikPen in the U.S. in the coming months in two concentrations: 500 units/mL and 1,000 units/mL. The company did not disclose pricing.”
  • Fierce Pharma adds,
    • “In just over a month, the FDA has cleared not one, but two treatments for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic condition that causes soft tissues to turn to bone. 
    • “Regeneron’s Pasatru earned regulatory clearance in late August, and Friday, Mirum Pharmaceutical’s zilurgisertib, to be marketed as Atebrioz, joined the race. The FDA has grantedMirum’s once-daily oral medication a green light to treat FOP in patients ages 12 and up.  
    • “Atebrioz has fallen under Mirum’s purview thanks to a licensing deal between the rare disease pharma and Incyte in April. Under the deal, Mirum paid $16 million up front for global commercial rights to the drug, with additional regulatory and sales milestones potentially to follow.”

From the fraud, waste, and abuse front,

  • Govexec reports,
    • “The Trump administration claims it found more than $1.2 billion in suspected fraud and stopped $41 million more across five COVID-related contracts, according to a Wednesday press release from the General Services Administration.
    • “GSA said although the COVID-19 national emergency and related acquisition flexibilities were cancelled in 2023, unnamed federal contractors continued to receive funding. The alleged fraud was uncovered in collaboration with the Health and Human Services Department and under the direction of the White House Task Force to Eliminate Fraud.
    • “The COVID emergency ended over three years ago, yet fraudsters continue to weaponize outdated emergency contracts to abuse taxpayer dollars,” GSA Administrator Edward Forst said in the release. “GSA will continue to work with the Vice President’s task force to stop improper payments, refer suspected fraud to law enforcement, and fight to recover every dollar.”
    • “GSA estimates that about 93% of the contract funding — which would have been distributed for COVID vaccines and other pandemic-related services — has not yet been distributed to vendors, while roughly 6.78% has already been expended, according to a Fox News exclusive attached to the release. The agency has suspended payments to contractors, although the uncovered funding is not currently tied to criminal charges for contractors, the outlet reported.”

From the judicial front,

  • The Hill reports,
    • “The U.S. Court of Appeals for the D.C. Circuit sided with the Trump administration in its blacklisting of the artificial intelligence firm Anthropic, allowing the Pentagon to label the AI firm a supply chain risk. 
    • “The 2-1 ruling, issued Friday [DC Circuit link], rejected Anthropic’s challenge of the designation, finding the Department of Defense had “ample support” for its belief that the continued use of Anthropic’s Claude models by the agency or its contractors presented a national security risk.” * * *
    • “Friday’s ruling breaks with a California federal judge’s decision last month finding the government violated the First Amendment when it issued the supply chain risk.” * * *
    • “A spokesperson for Anthropic said the firm “respectfully disagrees” with the appeals court ruling.
    • “Another federal court has already held the government’s parallel designation unlawful,” they added. “We remain confident in our position and are considering all options, including further review.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 25, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
      • “COVID-19 activity remains elevated but is declining nationally. COVID-19 hospitalizations remain low.
      • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
      • “RSV activity is very low.
      • “Seasonal flu activity is low.”
  • The University of Minnesota CIDRAP reports,
    • “The US measles count has climbed to 3,659 confirmed cases, with 171 new cases added this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “Of the 3,659 confirmed cases, 18% are in children age 5 and under, 43% in children and teens aged 5 to 19, and 38% are in adults 20 and older. Nine percent of case-patients have been hospitalized. Ninety-five percent of case-patients are unvaccinated or have unknown vaccination status.” * * *
    • “Pennsylvania remains the nation’s hot spot, with 129 new cases in the past seven days and 890 for the year, according to an update today from the Pennsylvania Department of Health. Lancaster County, where two of the state’s measles deaths have been reported, has been the hardest hit, with 342 cases. 
    • “Other states with notable increases in measles cases include Ohio, which added nine new cases this week and now has 189 for the year; Kentucky, which added 10 new cases and has 67 for the year; and Wisconsin, which added four new cases and has 171.”
  • and
    • “The bivalent (two-strain) respiratory syncytial virus (RSV) vaccine made by Pfizer (RSVpreF, or Abrysvo) reduced the risk of hospitalization and emergency department (ED) visits for at least three seasons after vaccination in older adults with a high prevalence of comorbidities, according to a study published last week in Infectious Diseases and Therapy. 
    • “A separate study published the same day in JAMA Network Openfound that RSV vaccines provided substantial protection against RSV-related hospitalization and death among adults aged 65 and older and people with weakened immune systems during the 2023-24 respiratory virus season. 
    • “RSV is a leading cause of lower respiratory tract disease (LRTD) with severe outcomes, particularly among older adults and those with compromised immune systems. The Centers for Disease Control and Prevention estimates that RSV contributes to around 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths among older adults in the United States each year.” 
  • Beckers Clinical Leadership relates,
    • “The death rate tied to three common, treatable emergency surgical conditions increased about 50% between 1999 and 2020, according to an abstract being presented at the American College of Surgeons Clinical Congress 2026 in Washington, D.C., Sept. 26-29.
    • “Researchers at Peoria, Ill.-based OSF HealthCare analyzed nearly 20,000 deaths from the CDC WONDER Multiple Cause of Death database to assess mortality trends tied to emergency general surgery conditions.”
    • “The conditions included in the study were appendicitis, acute cholecystitis and abdominal wall hernia with obstruction or gangrene, recorded as a contributing factor to — not necessarily the main cause of — death.” * * *
    • “The study “raises important questions about whether patients are getting to surgical care in time, especially in rural communities, and whether workforce shortages or other pressures are contributing,” Vishnu Mani, MD, the study’s lead author and emergency general surgery medical director at OSF HealthCare, said in a Sept. 25 news release.”
  • Beckers ASC Review tells us,
    • “Patients who had an appendectomy for acute appendicitis had a 58% lower relative risk of a later colorectal cancer diagnosis than similar patients treated with antibiotics alone, according to new research set to be presented at the American College of Surgeons Clinical Congress 2026 in Washington, Sept. 26-29.” * * *
    • “The management of acute appendicitis has changed significantly over the last decade, and antibiotic therapy is now an accepted option,” Valentine Nfonsam, MD, the study’s senior author and professor and executive vice chair of the department of surgery at Morehouse School of Medicine, said in the release. “We wanted to ask a different question: Are there potential long-term oncologic implications of leaving the appendix in place after appendicitis?”
    • “The exact mechanism behind the association is unclear, but researchers said it could involve earlier detection of an underlying malignancy, removal of a source of inflammation, or the appendix’s role in the gut microbiome and immune system. Dr. Nfonsam cautioned that the findings shouldn’t be read as a reason for every appendicitis patient to undergo surgery, and said age, genetic predisposition, family history and other colorectal cancer risk factors should still guide patient selection and follow-up. The findings are being presented as a research abstract and have not yet been peer-reviewed.”
  • Cardiovascular Business informs us,
    • “For-profit hospitals in the United States may be starting to fall behind their nonprofit counterparts when it comes to heart attack outcomes, according to new data published in JACC: Advances.[1] Readmission rates—a recognized sign of care quality—seem to be falling at nonprofit hospitals while they remain mostly unchanged at for-profit facilities.
    • “The study’s authors reviewed data from more than 4.6 million acute myocardial infarction (AMI) hospital admissions from 2013 to 2022. All data came from the Agency for Healthcare Research and Quality’s Nationwide Readmissions Database. ST-segment elevation myocardial infarction (STEMI) and non-STEMI diagnosis codes were used to identify AMI hospitalizations. 
    • “Overall, the AMI readmission rate at for-profit hospitals remained relatively stable from 2013 (13%) to 2022 (12.7%). At nonprofit hospitals, on the other hand, the AMI readmission rate dropped from 11.5% in 2013 to 10.5% in 2022. This same pattern was true when only looking at patients undergoing percutaneous coronary intervention (PCI) procedures. For patients undergoing coronary artery bypass grafting (CABG), meanwhile, both for-profit and nonprofit hospitals saw readmission rates decline over the course of the study.
    • “The authors also found that for-profit and nonprofit hospitals were linked to comparable in-hospital mortality rates. One area where for-profit hospitals bested nonprofit hospitals was reducing cardiac complications. Respiratory and renal complications, on the other hand, were more common at for-profit hospitals than they were at nonprofit hospitals.”
  • Healio adds,
    • “The stroke incidence rate among young adults nearly doubled from 1993 to 2020 while decreasing among older adults, according to research published in Neurology.
    • “Over that same time, researchers saw an increase in the percentage of patients with stroke who had substance use as well as conditions associated with vascular risk, such as hypertension, diabetes and atrial fibrillation, said Emily R. Fisher, MD, a neurology resident and fellow at the University of Cincinnati.
    • “Our findings highlight the importance of regular primary care, even for younger adults without chronic medical conditions,” Fisher told Healio. “Routine medical care and recommended screenings are very important to detect stroke risk factors and to address them appropriately, as one may not have symptoms from these conditions.”
  • and
    • “The risk for egg or peanut allergy in 1-year-olds was not lower among women who ate high vs. standard amounts of eggs and peanuts during pregnancy and lactation, according to data published in The New England Journal of Medicine.
    • “Based on these new large-scale trial results, clinicians can reassure pregnant women that they do not need to eat high amounts of common food allergy causing foods (such as eggs and peanuts) to reduce the risk of their baby developing these food allergies,” Debra J. Palmer, PhD, associate professor and head of nutrition in early life at The Kids Research Institute Australia, told Healio.”
  • Nature notes,
    • “Most people taking the popular GLP-1 drugs shed substantial amounts of weight — an average of one-quarter of their body weight according to one study1. So why do 10–15% of people using the drugs lose minimal weight or none at all?
    • “There is tremendous heterogeneity” in the response to these medications, says Daniel Drucker, an endocrinologist at the University of Toronto in Canada, whose work aided in the development of GLP-1 drugs. “And we really don’t understand that.”
    • “Solving this mystery might lead to new medications for people who do not benefit from today’s versions of such drugs and could make it possible to match individuals to treatments that are most likely to work for them. Those tantalizing possibilities have made people’s individualized responses to GLP-1s a key line of enquiry for obesity scientists. The Endocrine Society, a leading medical and research organization in Washington DC, has already called for it to be a priority for the field, with scientists looking into various explanations, including biological sex, genetics and behavioural factors.
    • “For now, research to identify the differences between those who do or don’t respond to the drugs is in its early days, and precision medicine for obesity remains “largely aspirational”, according to a scientific statement published by the Endocrine Society earlier this month. But researchers are starting to dig into these questions with energy.”

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

  • Per Tech Target,
    • “Employers can expect to pay 9.5% more for employee health benefits in 2027, with new reporting from professional services firm Aon projecting average employee healthcare costs totaling more than $19,000 in the coming year.
    • “These numbers reflect the fourth consecutive year of healthcare cost growth approaching double digits, the firm said.
    • “At this level, rising health care costs become much more than a budgeting challenge and influence organizational decisions from benefits strategy and employee affordability to broader workforce and financial planning priorities,” Mike Pasterick, North America Health Solutions leader at Aon, said in a statement. “Leaders are undergoing pressure to maintain affordable benefits while continuing to invest in attracting, supporting and retaining talent.”
    • “The drivers behind these healthcare cost increases might not be surprising. According to Aon, trends like increased healthcare utilization, greater chronic disease prevalence and the volume of high-cost claims all contribute to rising health benefits costs.”
  • Modern Healthcare reports,
    • “Penn Medicine, Independence Blue Cross and Regent Surgical are forming a company and plan to build and operate at least 18 ambulatory surgery centers. 
    • “The facilities will be located in Penn Medicine’s service area of Pennsyvania, New Jersey and Delaware. The first one is expected to open next year, a spokesperson said Friday. A timeline for when all facilities will be complete has not been announced.
    • “The venture will be structured as a for-profit company. Additional details were still being finalized, a spokesperson said. Regulatory approvals, market conditions and community needs will factor into the decisions.”
  • and
    • “Rightway, an upstart pharmacy benefit manager covering about 3 million people, is considering an initial public offering in the years ahead as it tries to chip away at a market long dominated by some of the largest healthcare conglomerates in the U.S.
    • “The closely held company was valued at $1.75 billion after it closed a recent fundraising round, according to a person familiar with the matter who wasn’t authorized to speak publicly.
    • “The public markets are where some of the best companies in the world are built,” Chief Executive Officer Jordan Feldman said in an interview. Rightway, which is profitable, is weighing a public market debut in the next four years, he said. “That public currency and transparency are certainly something that we strive toward.” * * *
    • “Rightway’s only revenue stream is a per-enrollee fee that is not related to the price of the drug, Feldman said. That leads to savings for clients on their overall drug expenses and slower spending growth, he said.”
  • The Wall Street Journal relates,
    • “Novo Nordisk agreed to pay up to $1.3 billion to license and develop Swedish pharmaceutical company Nanexa’s drug delivery technology in a deal that could cut the frequency that patients need to inject its obesity and diabetes drugs.
    • “The deal covers Nanexa’s PharmaShell technology, which is designed to enable controlled and sustained release of active pharmaceutical ingredients through an ultra-thin coating applied to individual drug particles.
    • “Under the exclusive deal announced late Thursday, Novo has licensed Nanexa’s technology in up to five development programs covering different drug administration frequencies, with the companies targeting monthly and quarterly administration.
    • “Novo will lead global development and commercialization, with Nanexa eligible to receive upfront consideration and potential milestone payments totaling up to 1.17 billion euros ($1.33 billion).
    • “The Danish drugmaker will pay 615 million euros in upfront and development and regulatory milestone payments, in addition to royalties on future product sales.”
  • Per BioPharma Dive,
    • “RNA drugmaker ADARx Pharmaceuticals on Thursday priced its $446.3 million initial public offering and received an additional boost with a separate investment from development partner AbbVie. 
    • “The biotechnology firm sold more than 26 million shares at $17 apiece, at the top end of the $15-$17 price point it originally laid out in federal filings. It also secured about $89 million through a private stock sale to AbbVie. ADARx begins trading on Nasdaq on Friday under the ticker symbol “ADRX.” 
    • “ADARx is one of a handful of companies specializing in what’s called RNA interference, a form of drugmaking that involves stopping the body from producing problematic proteins. Biotechs like Alnylam Pharmaceuticals and Arrowhead Pharmaceuticals have successfully brought RNAi drugs to market.”
  • Beckers Behavioral Health lets us know,
    • “OpenAI released MentalHealthBench, an open benchmark that measures how AI systems respond in realistic mental health conversations, on Sept. 23.
    • “The company built the benchmark with more than 80 licensed psychologists and psychiatrists from 22 countries. The cohort speaks 19 languages and represents nearly 20 mental health subspecialties. The benchmark scores model behaviors including safety, context-seeking, preservation of user agency and actionable guidance.” * * *
    • “OpenAI, whose ChatGPT reaches more than 1 billion people each week, released the benchmark openly so outside researchers can examine its methods and run their own evaluations.”
  • Per Radiology Business,
    • “Despite the increasingly unpredictable landscape of the healthcare sector, radiologists’ total cash compensation has remained steady, with some of the specialists enjoying an 18% increase in pay since 2024. 
    • “That’s according to new data from SullivanCotter’s 2026 Physician Compensation and Productivity Survey. The consulting firm’s annual survey includes data from 575 healthcare organizations representing approximately 235,000 physicians across 240 specialties. It contains detailed information organizations can use to help them navigate rising physician pay expectations, recruitment pressures and the changing metrics that define productivity. 
    • “According to the data, median total cash compensation increased year over year in 2026 across all major physician specialty categories. Adult medical specialties posted the largest gain, rising 7.2% from 2025 and 25.2% over the past five years.”  
  • Beckers Physicians Leadership tells us,
    • “Sixty-three percent of OB-GYNs and 63% of general surgeons have been named in a malpractice lawsuit, according to a new report from Medscape.
    • “Across all specialties, 33% of physicians said they had been a sole defendant, a co-defendant or both in a malpractice suit. That included 34% of specialists and 31% of primary care physicians.
    • “Medscape’s “Physicians and Malpractice Report 2026,” published Sept. 22, collected data from more than 1,100 full- and part-time physicians across nearly 30 specialties.”
  • Beckers ASC News informs us,
    • “The U.S. is projected to face a shortage of 27,940 surgeons by 2038, and vascular surgery is expected to be hit hardest, according to a study from the American College of Surgeons.
    • “The researchers called it the first unified assessment of the country’s surgical workforce. They used the Health Workforce Simulation Model from HHS to project supply and demand across 10 surgical specialties from 2023 to 2038, according to a Sept. 25 news release from the ACS.
    • “Nationally, surgeon supply is projected to fall 4.2% over the period while demand grows 12.8%. That would leave the workforce meeting 84.3% of need, with larger gaps in rural areas.”
  • Fierce Pharma notes,
    • “Total prescriptions for both Eli Lilly’s Foundayo and Novo’s Wegovy pill have bounced back following a holiday dip and reached new records. Weekly scripts for the Wegov pill jumped 14% sequentially to about 184K, compared with its previous high of 183K, according to IQVIA data cited by Citi. Foundayo climbed 13% to cross 50K for the first time, reaching 53,321.
    • “Foundayo now captures about 1 out of 3 new starts for oral GLP-1 obesity drugs, and “that’s growing week over week,” Lilly CEO David Ricks told CNBC in an interview this week. 
    • “As Leerink Partners analysts noted in a Sept. 23 note, effective Sept. 1, Lilly cut the initial-dose pricing for Foundayo 0.8 mg, 2.5 mg and 5.5 mg to $149, $149 and $199 per month for self-pay patients, respectively. The company framed the promotion as an elasticity experiment and as a push to the first maintenance dose, according to the Leerink note.
    • “As Jefferies analysts pointed out in a Sept. 25 note, the majority of Foundayo scripts seem to be cash pay, with about 80% of patients still on starting doses.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Never forget.

The New York Times reports

  • “Mourners and dignitaries gathered this morning in Lower Manhattan to honor the thousands of people who were killed on this day 25 years ago, when terrorists crashed two airplanes into the World Trade Center, shaking America and the world. It took four hours for family members of the victims to read aloud the names of all of the nearly 3,000 people who lost their lives: Gordon M. Aamoth Jr.; Edelmiro Abad; Marie Rose Abad …
  • “Solemn ceremonies were also held at the Pentagon and in Shanksville, Pa., where the other hijacked planes crashed. At the Pentagon, President Trump spoke of American resilience: “Sept. 11 reminded us of the terrible power of hate,” he said. “The 25 years since have shown us the even greater power of the American spirit to endure and prevail and to win.”
  • “All four other living presidents attended the memorial in New York. Zohran Mamdani, the city’s first Muslim mayor, was also in attendance, despite a petition signed by thousands of people, including the family members of some victims, urging him to stay away.
  • “That ceremony began, as always, at 8:46 a.m., with a beat of silence honoring the moment when the first plane, American Airlines Flight 11, struck the North Tower. Five more silences marked the times when other flights crashed and buildings fell. But this year, a new, seventh moment of silence was observed, to mourn those who have died from cancer and other illnesses inflicted by the toxic dust they inhaled after the attacks.”

From Washington, DC,

  • Tammy Flanagan, writing in Govexec, tells us,
    • Every year, the anniversary of Sept. 11, 2001, brings back the same difficult truth: federal service is not always performed behind a desk, and risk does not always announce itself in advance. Sixty-nine federal employees were among those who died that day — including 62 at the Pentagon, three at the World Trade Center, three aboard Flight 93, one aboard Flight 77 at the Pentagon and one aboard Flight 175 at the World Trade Center. Many more reported for duty afterward to secure facilities, investigate the attacks, transport people, provide emergency assistance and help the country recover.
    • For their families, the lesson is not only one of remembrance. It is also a benefits lesson. If a civilian federal employee is injured, develops an occupational illness or dies because of federal employment, the Federal Employees’ Compensation Act may provide important protection.
    • FECA is the federal government’s workers’ compensation program for civilian employees, administered by the Labor Department’s Office of Workers’ Compensation Programs. It can pay for medical treatment, replace part of lost wages, provide compensation for permanent impairment and, in fatal cases, provide benefits to eligible survivors.
    • This is where many employees and families get into trouble: They know there are “benefits,” but they do not know which benefit applies, who administers it or what evidence is needed. A traumatic injury is generally tied to a specific incident during one workday or shift and is reported on Form CA-1. An occupational disease or illness develops over more than one workday or shift and is reported on Form CA-2. Wage-loss compensation is generally claimed separately, often with Form CA-7.
    • These distinctions are more than paperwork. They affect deadlines, agency responsibilities, medical documentation and how the claim is developed.
  • FEHBlog observation: While OWCP pays benefits before FEHB /PSHB plans for OWCP compensable illnesses and injuries, OWCP does not give the beneficiary an OWCP benefits ID card which would put the provider on notice to bill OWCP, not the FEHB/PSHB plan.
  • Healthcare Dive reports,
    • “The number of hospitals complying with price transparency rules is increasing. But more than half of facilities still aren’t posting full information about the cost of their services, according to the latest analysis from PatientRightsAdvocate.org.
    • “About 51% of U.S. hospitals aren’t fully complying with the rules, despite them taking effect more than half a decade ago, according to the patient advocacy group’s latest scorecard of 2,000 hospitals.
    • “Still, the roughly 49% of hospitals in compliance is up significantly from the last time PRA analyzed the industry in 2024, and is the highest rate since the group began tracking the issue in 2021. PRA chalked the improvement up to regulators stepping up enforcement.”
  • AHIP adds,
    • “Hospital spending makes up the largest share (40%) of health insurance premiums and continues to grow, now exceeding $1.6 trillion annually. One major driver of high hospital costs is that routine services are often reimbursed at substantially higher prices — sometimes up to 13 times more — in hospital outpatient departments (HOPDs) than in physician offices and other non-facility settings, even though the care is the same.” 
  • Beckers ASC Review tells us,
    • “Physician assistants and advanced practice registered nurses can now order every noninvasive colorectal cancer screening test Medicare covers, ending a long-standing physician-only requirement under a CMS coverage change.
    • “CMS authorized the expanded coverage in June when it finalized a decision memo revising the “Screening for Colorectal Cancer — Non-Invasive Biomarker Tests” national coverage determination, the American Academy of Physician Associates said in a Sept. 10 news release.
    • “The determination previously covered the tests only when a physician ordered them. CMS reopened it after new evidence emerged on stool-based RNA tests.
    • “PAs and APRNs may now order RNA-based stool tests, DNA-based stool tests, DNA-based blood tests and fecal occult blood tests.”
  • Beckers Hospital Review informs us,
    • “Johnson & Johnson will require 340B covered entities to submit claims-level data for its covered outpatient drugs starting Sept. 15, according to a notice the drugmaker sent to providers Sept. 4.
    • “Covered entities that don’t submit will receive at least two noncompliance notices and a notice of pricing suspension, with suspension beginning at least five business days after the final notice. J&J said 340B pricing will be restored within 10 business days once a covered entity submits compliant data.
    • “The policy applies to all covered entity types regardless of dispensing or administration location, inventory management system or payer coverage. J&J said it will continue to offer 340B pricing upfront at the time of purchase rather than moving to a rebate model, and that the policy supersedes claims-data provisions in a prior notice from February 2023.
    • “Covered entities must submit data within 45 days of a drug’s dispensation; a list of oncology, autoimmune and other specialty drugs, including Stelara, Darzalex and Tremfya, carries a 60-day window.” 

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

  • Federal New Network offers an interview with OPM Director Scott Kupor, and further reports
    • “Federal employees’ performance ratings will now be the top consideration during future reductions in force, as a final rule from the Office of Personnel Management takes full force this month.
    • “OPM’s final regulations, which became effective Sept. 2, mark a significant turning point in the way agencies develop RIF retention registers, which determine whether employees are retained, reassigned, demoted or separated during RIFs.
    • “Following the publication of the final rule in August, OPM detailed further expectations about the new system in guidance to agencies. During any future RIFs, agencies will have to rank employees using a point system directly tied to their performance ratings. An employee with a level 5 performance rating will receive seven points on the RIF register, while level 4 receives five points; level 3 receives three points; and levels 1 and 2 each receive zero points.
    • “Agencies will also place competitive service and excepted service employees on separate retention registers in any future RIFs. Within each list, employees will then be numerically ranked based on their performance levels, with points added for veterans’ preference. Tenure and seniority will be used only as tiebreakers between employees.”

From the Food and Drug Administration front,

  • The Pharmacy Times reports,
    • “The FDA approved leniolisib (Joenja; Pharming Healthcare) tablets for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 to 11 years who weigh at least 27 kg. The decision makes leniolisib the first FDA-approved treatment for children in this age and weight group with the rare genetic immune disorder.”
  • Cardiovascular Business relates,
    • “Emboline, a California-based medtech company, has received U.S. Food and Drug Administration (FDA) approval for its Emboliner Embolic Protection System. The device was built to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) procedures. This is seen as a way to reduce the risk of stroke, which clinicians have been battling since TAVR was first introduced, as well as other potential complications.
    • “We developed the Emboliner to address important unmet needs with existing embolic protection approaches for TAVR,” Scott Russell, president and CEO of Emboline, said in a statement. “We are excited to now be able to put the Emboliner in the hands of physicians so that they can offer a more comprehensive embolic protection solution for their patients. We are grateful to the clinical investigators whose partnership and feedback helped us reach this point.”
    • “The Emboliner device includes a self-expanding filter that covers all three cerebral vessels. The filter’s double-layer mesh captures debris without restricting blood flow in any way.
    • “Emboline plans on beginning its commercial launch of the newly approved device by the end of 2026.”
  • Fierce Pharma tells us,
    • “The FDA has delayed its approval decision for Exelixis’ oral kinase inhibitor zanzalintinib in combination with Roche’s Tecentriq for the treatment of patients with metastatic colorectal cancer (mCRC). 
    • “Exelixis explained in a Securities and Exchange Commission filing that the agency has asked for the extension while it awaits updated safety and efficacy data from the company. It means the biopharma should now expect a decision in March 2027 as opposed to the previous deadline of Dec. 3, 2026.”

No Surprises Act News

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury have added Physio Solutions, LLC as a new independent dispute resolution entity increasing the total to 17. IDR arbitrators help make payment determinations in disputes between providers, group health plans and health insurance issuers under the No Surprises Act.”
  • Beckers Payer Issues summarizes five other recent NSA updates for us.

From the judicial front,

  • Bloomberg Law reports,
    • “A federal judge blocked the Trump administration’s use of a question for federal job applicants that critics said amounted to a test of their political beliefs. 
    • “The Trump administration can no longer require thousands of government job seekers to say why the president’s policies are personally significant to them, and how they would further them if hired, according to a Friday ruling in the US District Court for the District of Massachusetts.” * * *
    • “While the ruling prevents the administration from using the question on job applications, O’Toole denied the unions’ request for a broader preliminary injunction barring the government from incorporating applicants’ answers or non-answers into hiring decisions. 
    • The case is AFGE v. Kupor, Office of Personnel Management, D. Mass., 25-13305-GAO, 9/11/26

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 11, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP adds,
    • “The number of confirmed US cases of measles has reached 3,294, fully 1,000 more than all of last year, the Centers for Disease Control and Prevention (CDC) noted in its weekly update today. 
    • “The total includes 160 new cases, most of them in Pennsylvania, the nation’s measles hot spot. The country has now seen five straight weeks of triple-digit increases.”* * *
    • “As noted in the data from the CDC map, cases in Wisconsin are also ramping up. In an update today, the Wisconsin Department of Health Services (DHS) confirmed 163 cases across the state so far this year. Four cases are new since September 8.” * * *
    • “Ohio this week confirmed 11 new cases, 133 total. In good news, Utah, which was a measles hot spot earlier this year, has gone more than three weeks without a confirmed case. Its case count stands at 518.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention Sept. 10 released an advisory on a nationwide increase of reported human exposures to rabid or possibly rabid animals and rabies post-exposure prophylaxis administration errors. The CDC said it received 17% more rabies-related inquiries from July through August this year — including reports of mass exposure events — compared to the same period in 2025. The agency said that weekly pharmacy data as of Sept. 2 showed that utilization for the two rabies vaccines and two rabies immunoglobulins licensed in the U.S. increased by an estimated 33% and 76%, respectively, compared with the same period last year. The advisory includes recommendations for clinicians and healthcare facilities on rabies treatment and appropriate rabies PEP assessment and administration.”
  • The Wall Street Journal informs us,
    • “Public-health officials declared an end to a cyclosporiasis outbreak linked to iceberg lettuce that spread across the U.S. this summer.
    • “The outbreak has resulted in a total of 12,883 reported cases of the gastrointestinal food-borne illness across 21 states, the Centers for Disease Control and Prevention said Friday.
    • “Federal health officials have linked the outbreak to shredded iceberg lettuce from Taylor Farms, a major supplier of fresh produce to retailers such as Walmart, Costco Wholesale and Amazon.com’s Whole Foods Market, as well as restaurant chains including McDonald’s and Yum Brands’ Taco Bell.
    • “The CDC said the contaminated lettuce linked to the outbreak is no longer available in stores or restaurants, and the products’ best-by dates have passed. Recent infections linked to the outbreak have declined, with fewer than two infections per day on average in August compared to a peak of more than 1,000 daily infections, the CDC said.”
  • Health Day points out,
    • “Talking to a counselor before major surgery might boost seniors’ recovery following a procedure, a new study says.
    • “Mental health coaching before surgery can help reduce seniors’ risk of post-surgery anxiety and depression, researchers reported Sept. 9 in JAMA Network Open.
    • “The time around surgery is a window of both risk and opportunity,” lead researcher Joanna Abraham said in a news release.
    • “The stress of surgery can worsen anxiety and depression symptoms and affect patients’ recovery and overall health, but it also offers a critical opportunity to identify these concerns proactively and connect patients with the support they need,” said Abraham, a professor of anesthesiology at Washington University School of Medicine in St. Louis.”
  • Nature notes,
    • “Injected vaccines can raise an army of antibodies in the blood to stave off major illness, but don’t prevent infection at the points where respiratory viruses enter the body. Researchers hope that nasal vaccines could bolster protection at the moist mucosal barriers that line the respiratory tract, which could enable a person to rapidly ward off pathogens and prevent them from spreading a virus to others. A long line of failures demonstrates that developing a mucosal vaccine is a challenging task, but their promise is still enough to maintain commercial interest.”
  • Per Beckers Clinical Leadership,
    • “The rise of GLP-1 medications is one of the most consequential changes in obesity care in decades. Not surprisingly, bariatric surgery is feeling the impact. As patients gain access to powerful medications such as semaglutide and tirzepatide, fewer are immediately choosing an operation. The trend is real, but [as explained in the article,] the conclusion that GLP-1s will simply replace bariatric surgery misses the larger story.”

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

  • Beckers Hospital Review reports,
    • “Septicemia is the most expensive condition treated in hospitals, amounting to $60 billion in annual costs, a Healthcare Cost and Utilization Project report found. 
    • “The report, published February 2026, used 2022 data from the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project on hospital costs of inpatient stays in nonfederal acute care hospitals. Using the 2022 HCUP National Inpatient Sample, the report found the distribution of costs by primary expected payer and the conditions that accounted for the largest percentage of payer’s hospital costs. Hospital charges were converted to costs using HCUP cost-to-charge ratios. Payers included Medicare, Medicaid, private insurance and self-pay/no charge. 
    • “The report found: 
      • “The aggregate hospital costs for 32.9 million hospital stays totaled $548.5 billion.
      • “The 20 most expensive conditions account for 46.8% of aggregate hospital costs in 2022, and amounted to 43.1% of all hospital stays.
      • “Septicemia accounted for 10.9% of aggregate costs for all hospital stays in 2022 across all payer groups — more than three times higher than the next most expensive condition: liveborn infants which accounted for 3.6% of aggregate costs.
      • “Among the most expensive conditions, liveborn infants were the most common reason for hospitalization at 10.6% of all hospital stays, followed by septicemia at 7.4%, heart failure at 3.3% and COVID-19 at 2.5%.
      • “Circulatory system conditions were the most frequent of the top 20 diagnoses for Medicare, private insurance or self-pay/no charge.
      • “Pregnancy and childbirth conditions were the most frequent among the top 20 conditions for Medicaid.”
  • and
    • “More than 150 independent rural hospitals across eight states have banded together into clinically integrated networks over the past three years, betting that shared scale, data and negotiating leverage can keep them out of the arms of consolidating systems and payers.
    • “The newest addition is the Show-Me High Value Network, a Missouri coalition of 23 independent hospitals that collectively serve more than 1.8 million residents across urban, rural and underserved communities. It joins a fast-growing map of rural high-value networks that includes: 
    • “Cibolo Health, a Texas-based consultancy that specializes in building rural hospital collaboratives, manages seven of the networks, including those in North Dakota, Minnesota, Ohio, Montana, Nebraska, Wisconsin and Kansas.”
  • and
    • “St. Louis-based Mercy recorded an operating income of $500.8 million (4.5% margin) for fiscal year 2026, up from $21.4 million (0.2% margin) in fiscal 2025, according to its Sept. 11 financial report.”
  • and
    • “Hershey, Pa.-based Penn State Health reported a $131.2 million operating gain on $5 billion in revenue for the fiscal year ended June 30, a significant improvement from the prior year, according to its audited financial statements.”
  • Beckers Payer Issues relates,
    • “Ujjwal Ratan has joined UnitedHealth Group’s consulting and analytics division, Optum Insight, as chief AI officer.
    • “In a Sept. 10 LinkedIn post, Mr. Ratan said his role is to enable Optum Insight to operate as a connected agentic network in healthcare.”
  • and
    • “Taft Parsons III, MD, is leaving his role as CVS Health’s chief psychiatric officer.
    • “Executives decide to try something different, and organizational structures and jobs change,” he said Sept. 11 on LinkedIn. “I’ve benefited from those changes more often than not, and I understand this is simply my turn to find another path toward improving healthcare.”
  • Beckers ASC Review tells us,
    • “National Healthcare Properties completed the sale of 30 primarily multi-tenant outpatient medical facilities for $198 million.
    • “The transaction represents the first tranche of its previously announced sale of 86 outpatient medical facilities for approximately $528 million, according to a Sept. 10 news release from the company. The remaining 56 facilities are expected to close in the fourth quarter of 2026.”
  • The Wall Street Journal points out,
    • “France’s Ipsen IPN is considering building a production site in the U.S., joining other European drugmakers looking across the pond when planning new investments.
    • “Discussions are ongoing,” Ipsen Chief Executive David Loew said in an interview. “No decision has been reached yet on exactly when, but this is certainly something that we are taking into consideration.”
    • “Loew said the next big plant the company builds will manufacture either its Dysport drug—a rival to AbbVie’s ABBV Botox—or a next-generation medicine called corabotase that is still under development.
    • “Many of the world’s top pharmaceutical companies pledged to make multibillion-dollar investments to bring manufacturing and other operations to the U.S. over the coming years, in a bid to mitigate tariff threats by the Trump administration. In addition to big companies like AstraZeneca and Roche, smaller drugmakers like Belgium’s UCB and Australia’s CSL also plan to invest in new U.S. facilities.”
  • Fierce Pharma lets us know,
    • “Both Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo saw their highest total prescriptions so far over the past week as the companies’ oral obesity battle continues to play out.  
    • “According to IQVIA data cited by Citi, the Wegovy pill reached an approximate 183K total scripts for the most recent reporting period, versus 181K the week prior. Foundayo, for its part, climbed nearly 8% to reach 47.5K scripts. Citi analysts emphasized that IQVIA may still be missing some Foundayo prescriptions made through telehealth channels. 
    • “Meanwhile, using the last four weeks as a guide, total GLP-1 prescriptions have increased by 5.4%, compared to a 6.8% decline the prior year, the Citi team said. Citi analysts attributed the 12-percentage-point swing to the expansion of oral GLP-1 therapies, which is likely broadening access to the class and drawing in new patients.  
    • “Across the broader landscape, Lilly’s tirzepatide currently holds a nearly 57% share of the total GLP-1 market, compared to around 49.5% last year, while Novo’s semaglutide has stayed relatively flat at a 37% share, the analysts added.”  

Friday report

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

Simplicity is a virtue.

From Washington, DC

  • The Hill reports,
    • “Bipartisan House lawmakers, including two battleground Republicans, introduced legislation Thursday to ensure people with private health insurance don’t pay more than $35 a month for insulin. 
    • “Lawmakers have discussed the idea of an insulin cap for years but haven’t been able to get legislation over the finish line over GOP resistance to government setting prices.  
    • “But two Republicans in contested battleground districts signing on shows that the GOP is trying to address concerns about the cost of healthcare ahead of the midterm elections.  
    • “The Insulin Act — shorthand for the Improving Needed Safeguards for Users of Lifesaving Insulin Now Act — was introduced by Reps. Diana DeGette (D-Colo.), Angie Craig (D-Minn.), Kim Schrier (D-Wash.), Mariannette Miller-Meeks (R-Iowa) and Rob Bresnahan (R-Pa.). 
    • “It’s a companion version of legislation that advanced through the Senate Health Committee earlier this summer. That bill is being pushed by Sens. Susan Collins (R-Maine), Jeanne Shaheen (D-N.H.), Raphael Warnock (D-Ga.) and John Kennedy (R-La.). In total, it has 28 co-sponsors divided equally between the parties.” 
  • Beckers Payer Issues relates,
    • “House Democrats are discussing a healthcare policy agenda that could include an expansion of the Medicare program, the Washington Post reported Sept. 3.
    • “House Minority Leader Hakeem Jeffries told NBC News that reversing the Medicaid cuts under H.R.1 and reviving enhanced ACA premium tax credits have “uniform Democratic support” ahead of the midterms. But privately, members have been discussing a broader expansion of Medicare, including widening eligibility, adding new benefit categories and capping enrollee costs, as well as creating some form of public insurance option, according to the Post, citing four people familiar with the discussions. 
    • “Breaking up vertically integrated healthcare companies like UnitedHealth Group and CVS Health is also under discussion, the Post reported, mirroring a theme that has drawn bipartisan support in Congress since January’s hearings with the CEOs of major insurers.
    • “Other policy ideas Democrats are reportedly looking at are cracking down on Medicare Advantage billing practices they say are fraudulent, expanding Medicare’s authority to negotiate drug prices beyond the current scope under the Inflation Reduction Act, passing a federal right to abortion and providing public coverage to people up to 26 years old.”
  • and
    • “CMS has rebranded individual coverage health reimbursement arrangements to CHOICE Arrangements, or Custom Health Option and Individual Care Expense.
    • “The new name for the alternative health insurance model was announced Sept. 3 by CMS Administrator Mehmet Oz, MD, at an event in Indiana.
    • “ICHRAs let employers give workers a fixed, tax-free amount to buy their own individual health insurance on or off the exchange instead of offering a traditional group plan. The number of people covered by ICHRAs surpassed 500,000 at the start of 2026, according to the HRA Council.”
  • Beckers Hospital Review adds,
    • “States are earmarking specific slices of their Rural Health Transformation Program dollars for technology upgrades, service expansions and workforce pipeline development.
    • “[As noted in the FEHBlog] CMS has announced 15 such efforts over the past month. Each state’s full fiscal year 2026 award was set in December 2025, when CMS approved $50 billion in Rural Health Transformation Program funding across all 50 states. The entries below represent specific initiatives or sub-awards within those existing awards — not new money on top of them.
      • New York — $76 million. CMS said Sept. 4 the funding will strengthen coordination among rural hospitals, primary care providers, federally qualified health centers and behavioral health providers, and expand clinical training programs for the rural workforce.
      • Michigan — $25 million. The funding will modernize healthcare technology, expand telehealth and remote patient monitoring capabilities, and improve high-speed internet connectivity in rural areas, according to a Sept. 4 news release. 
      • Rhode Island — $5.48 million. CMS announced Sept. 4 that the funding will expand career and technical education in healthcare fields at 14 local education agencies and schools, building student pathways into nursing, EMS, behavioral health and other high-demand professions.
  • Per a Department of Health and Human Services news release ,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today awarded $11.2 million to support the development of 15 new physician residency programs in rural communities across 14 states. The Rural Residency Planning and Development (RRPD) Program awards will create new residency programs in family medicine, internal medicine, preventive medicine, psychiatry, and general surgery, helping to strengthen the health workforce in rural and tribal communities.
    • “Where you live should not determine whether you can find a doctor,” said HHS Secretary Robert F. Kennedy, Jr. “We are bringing physician training directly into rural and tribal communities, where doctors are needed most. By training physicians in these communities, we can build a stronger local workforce, expand access to care, and ensure rural families can get the care they need close to home.”
    • “Since the RRPD program was established in 2019, HRSA has invested nearly $77 million across 36 states and one territory to build a pipeline of physicians trained in rural communities. As of July 2026, these investments have resulted in 66 accredited rural residency programs, 818 approved residency positions, and more than 850 resident physicians enrolled in rural training settings.”

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

  • Federal News Network reports,
    • “Agencies may get more flexibility in disciplining federal employees, after the Merit Systems Protection Board finalized a rule ending decades-old standards for reviewing misconduct cases.
    • “MSPB on Thursday lifted a requirement to consider the “Douglas factors” in every employee misconduct case — 12 considerations the board has used for the last 45 years to determine whether a penalty, such as a firing or demotion, was reasonable.
    • “Once the final rule takes effect in 30 days, MSPB will evaluate whether an agency’s penalty for an employee accused of misconduct was reasonable on a case-by-case basis rather than reviewing all 12 considerations listed under the Douglas factors.
    • “Stemming from a 1981 Department of Veterans Affairs case, MSPB has relied on the Douglas factors in reviewing misconduct appeals, looking at the seriousness of the offense, the employee’s disciplinary record, and the potential for the employee to be rehabilitated, among other considerations.”
  • and
    • “Federal employees traveling for business will see a slight bump in their daily reimbursable allowance, according to new per diem rates set by the General Services Administration.
    • “Starting Oct. 1, employees on official travel will see a $3 increase in the standard lodging per diem rate, from $110 to $113, GSA announced last month. Allowances for meals and incidental expenses (M&IE) will remain between $68 and $92 for the upcoming fiscal year, with the lower end of that range serving as the standard base rate.
    • “Agencies use per diem rates to reimburse federal employees for lodging, meals and other expenses during official travel. GSA announces the government’s per diem rates each August, ahead of the upcoming fiscal year.”

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns who cannot receive nutrition by mouth or through a feeding tube.
    • “The FDA became aware of the potential supply gap after children’s hospitals raised concerns about continued access to neonatal starter parenteral nutrition. The concerns were based on the discontinuation of certain standardized neonatal starter PN products made by two outsourcing facilities that are permanently shutting down.
    • “The FDA is committed to deploying every regulatory tool available to prevent critical supply chain gaps from threatening patient care,” said Acting FDA Commissioner Kyle Diamantas, J.D. “We are working closely with healthcare providers and industry partners to help ensure that vulnerable populations continue to have access to the care they need.”
  • and
    • “The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.
    • “FDA granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy, based on an FDA-authorized test.
    • “ESR1 mutations are acquired resistance mutations that a tumor may develop during treatment with an aromatase inhibitor, a type of endocrine therapy that is a common front-line treatment for locally advanced or metastatic breast cancer. At the diagnosis of HR-positive metastatic breast cancer, fewer than 5 percent of patients will have this tumor mutation. After disease progression on an aromatase inhibitor, nearly 40 percent of patients will have this tumor mutation.
    • “Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment. We owe them every weapon in our arsenal.” said Acting FDA Commissioner Kyle Diamantas, J.D. “Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”
  • Cardiovascular Business relates,
    • “Powerful Medical, a New York-based medtech company, has been granted De Novo authorization from the U.S. Food and Drug Administration (FDA) for an artificial intelligence (AI) model designed to detect signs of an ST-elevation myocardial infarction (STEMI) in electrocardiography results.
    • “The newly authorized AI model, Queen of Hearts, can flag STEMI as well as STEMI equivalents. It was trained by Stephen W. Smith, MD, an emergency physician at Hennepin County Medical Center. The technology already gained European CE mark approval and it received the FDA’s breakthrough device designation in March 2025. Approximately seven months later, new data on Queen of Hearts was presented at TCT 2025 in San Francisco and simultaneously published in JACC: Cardiovascular Interventions.[1] That study linked the advanced AI model to a significant improvement in heart attack detection and a reduced risk of false-positive alerts.
    • “With this FDA authorization in place, Powerful Medical is now ramping up the deployment of its PMcardio platform, which can embed Queen of Hearts—and other algorithms when desired—into existing clinical workflows.” 

From the judicial front,

  • Per a Department of Justice news release,
    • “Two Florida men were sentenced to multiple years in prison for their roles in a $34.8 million health care fraud conspiracy billing Medicare for thousands of orthotic braces sent to Medicare beneficiaries who did not need them.
    • “These fraudsters billed Medicare $34.8 million for braces that patients didn’t need and didn’t request — and now they’re paying the price,” said Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division. “They paid kickbacks for fake doctors’ orders, shuffled billing among several companies to dodge payment suspensions, and pocketed millions that belonged to American taxpayers. Their prison sentences make clear: if you steal from Medicare, you will be caught, you will be prosecuted, and you will be held accountable.”
    • “According to court documents, Kenneth Charles Kessler III, 43, of Miami, Florida, and Michael Andrew Gomez, 43, of Miramar, Florida, owned and operated seven durable medical equipment (DME) supply companies based in Florida. Through these DME companies, they submitted millions of dollars in false claims to Medicare for medically unnecessary orthotic braces.
    • “Kessler and Gomez also paid illegal kickbacks and bribes to obtain fraudulent signed doctors’ orders. They used these orders to ship orthotic braces to Medicare beneficiaries nationwide, including to beneficiaries who neither requested nor needed the braces, and then claimed payment for those braces from Medicare. Kessler and Gomez used their multiple DME companies to evade Medicare payment suspensions by shifting their fraudulent billing between their DME companies.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 4, 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.”
  • Yahoo adds,
    • “As the most up-to-date vaccines are set to come out, Texas has experienced rising rates of COVID infection, data suggests. 
    • “Wastewater COVID readings in Texas have surged well beyond the national average, starting in July, according to data from the Centers for Disease Control and Prevention. 
    • “The state’s wastewater viral activity level hovered a little above the U.S. average through most of June. It crested twice in the summer before reaching the CDC’s “very high” threshold during the week ending Aug. 22, the latest date for which data is available. 
    • “Texas was the only state in the nation with “very high” wastewater COVID levels as of Aug. 22. Wastewater data can alert public health officials to rising illness beyond other indicators, like positive test rates, ER visits and deaths, which have limitations due to how they’re collected.”
  • Per a Walgreens news release,
    • “Walgreens is now offering 2026-2027 COVID-19 vaccines for eligible patients.1 With multiple viruses and seasonal illnesses expected to circulate this fall and winter, Walgreens is making it easy for patients to stay protected by offering COVID-19, flu, RSV, pneumococcal and other recommended vaccines during a single visit. 
    • “Patients can walk into their local Walgreens pharmacy or schedule an appointment at Walgreens.com/ScheduleVaccine, through the Walgreens app, by texting “Flu” to 66879 or by calling 1-800-WALGREENS in most states. 
    • “As respiratory virus season ramps up, many people are thinking about how to protect themselves and their loved ones,” said Rick Gates, chief pharmacy officer, Walgreens. “Getting multiple recommended vaccines at the same time is a safe and effective way to reduce the risk of illness and help protect yourself, your family and your community heading into the fall and winter. Our goal is to make getting vaccinated as convenient as possible so patients can save time and stay protected.” 
  • MedPage Today tells us,
    • “Viral persistence is thought to be a possible cause of long COVID.
    • “In this phase II trial, nirmatrelvir-ritonavir (Paxlovid) — which is approved for acute COVID-19 — was no better than placebo-ritonavir at reducing long COVID symptoms.
    • “The NIH-sponsored study included participants with cognitive, autonomic, and exercise phenotypes.”
  • The University of Minnesota CIDRAP reports,
    • “Today, the CDC updated the country’s measles case count, which stands at 3,134, including the two Pennsylvania deaths. Eight percent of measles patients have been hospitalized. 
    • “Of the total, 231 infections are new. That compares with 126 new cases last week.
    • “Of all cases, 94% occurred in people who were unvaccinated or had an unknown vaccination status. All cases but 16 were locally transmitted. In all of 2025, 2,289 measles case were confirmed in the United States.
    • “In Pennsylvania, officials today added 115 new cases—about half of all new US infections—from the past week to its state case tally, raising it to 577 cases. None of the state’s cases involve people fully vaccinated against the virus. In total, 98 people (17%) have been hospitalized. Thirty percent of infections occurred in children.
    • “The Pennsylvania Department of Health also warned that travelers at the New Stanton Service Plaza on the westbound Pennsylvania Turnpike in Westmoreland County may have been exposed to measles by a person from another state who stopped at the plaza on August 17 and later tested positive for the virus.
    • “On the cusp of the Labor Day weekend, which entails travel for many people, healthcare professionals are urging travelers to be vigilant in monitoring for symptoms of the highly contagious disease, such as rash, fever, and red, watery eyes.
    • “Ohio is reporting 15 new cases, including five cases in Wayne County, amid its third measles outbreak of the year, raising its tally for the year to 122.” 
  • and
    • “For the fourth year in a row, the number of US teenagers being vaccinated against human papillomavirus (HPV) has not increased, according to survey results published yesterday in Morbidity and Mortality Weekly Report. 
    • “A smaller percentage of adolescents received the HPV series compared with recipients of the tetanus, diphtheria, and pertussis (whooping cough) vaccine (Tdap) and the conjugate meningococcal vaccine against the A, C, W, and Y strains (Men ACWY). But uptake of these immunizations declined slightly from last year. 
    • “The consistently lower HPV vaccination coverage compared with other routine adolescent vaccines might, in part, reflect differences in school entry requirements,” wrote the authors, from the Centers for Disease Control and Prevention (CDC). “Tdap is required for school entry in all states, and MenACWY is required in most states; however, few states require HPV vaccination.” * * *
    • “Continued efforts are needed to increase adolescent vaccination coverage with recommended vaccines and reduce geographic differences in coverage, particularly with HPV vaccine,” the authors wrote. “Efforts to address barriers to vaccination, including improving access to preventive care, strengthening provider communication regarding recommendations, and increasing vaccine confidence, could help improve coverage.”
  • The Washington Post offers a look at “The behind-the-scenes effort to contain the nation’s worst ongoing measles outbreak.”
    • Public health workers are relying on word of mouth to fight the largest ongoing outbreak in the United States.
  • Beckers Clinicial Leadership informs us,
    • “Two patients who received genetically engineered pig kidney transplants at Somerville, Mass.-based Mass General Brigham have since successfully undergone human donor kidney transplants, Cambridge, Mass.-based eGenesis said in a Sept. 3 update on its Expanded Access program.
    • “The cases mark the first reported transitions from xenotransplantation to allotransplantation, according to eGenesis, and provide early evidence that a genetically engineered pig kidney can bridge patients to a human donor organ.”
  • and
    • “Death rates from cancers associated with alcohol consumption doubled between 1990 and 2023, according to a study published Sept. 2 in The Lancet Regional Health — Americas. 
    • “Led by the Sylvester Comprehensive Cancer Center at the University of Miami, researchers used the Global Burden of Disease database to analyze age-standardized mortality rates for all cancers and 10 specific cancers, and the percentage of those rates that could be attributed to heavy alcohol use, between 1990 and 2023.”
  • Health Day points out,
    • “A person’s memory starts to get worse much sooner than previously thought, a new study says.
    • “Folks in their 50s start showing signs of decreased memory function, likely due to changes in the brain region responsible for stabilizing memories, researchers reported recently in the journal Cerebral Cortex.
    • “This is one of a growing list of studies highlighting that the period of middle age is really important for memory functioning and shouldn’t be ignored,” senior researcher Ian McDonough, an associate professor of psychology at Binghamton University in New York, said in a news release.”
  • and
    • “Simple walking tests could be an easy way to assess the well-being of a patient with multiple sclerosis (MS), a new study says.
    • “Better walking performance and higher levels of daily physical activity are linked to better quality of life among people with intermittent forms of MS, researchers report in the October issue of the journal Multiple Sclerosis and Related Disorders.
    • “These findings reinforce previous research and highlight the potential benefits of maintaining an active lifestyle,” lead author Marko Luostarinen, a doctoral researcher at the University of Eastern Finland, said in a news release.”
  • Per BioPharma Dive,
    • “AbbVie said its dual-acting drug for multiple myeloma met the main goal of a Phase 3 clinical trial, helping people who’ve progressed on two or more lines of therapy survive longer without progression than those who received standard treatment regimens, the company said Thursday.
    • “The drug, called etentamig, could be safer than rival drugs launched by Johnson & Johnson, Pfizer and Regeneron, with low rates of two kinds of serious immune responses common to other drugs of its type. AbbVie said its safety profile could enable greater use in community oncology centers because of reduced need for post-treatment patient monitoring.
    • “Etentamig is a type of drug called a bispecific antibody that can simultaneously bind to diseased tumor cells and T cells, triggering an immune response to fight multiple myeloma. It trails by more than four years the first drug in its class, J&J’s Tecvayli, which booked $462 million in sales through the first six months of 2026.”
  • The Wall Street Journal notes,
    • “Bristol Myers Squibb told regulators, researchers and patient-advocacy groups in early June that it had paused closely watched drug research because of life-threatening side effects. It took three months for the company to share that with the broader public.
    • “Novartis paused research into a similar therapy last month, which it confirmed only after a Wall Street analyst noticed while scouring a database. It took a week for the company to reveal that three study patients had died.
    • “Novartis and Bristol Myers are both studying their own new forms of faster-to-produce CAR-T therapy for autoimmune diseases, a promising new area of drug research that re-engineers a person’s own cells to attack disabling conditions such as lupus or rheumatoid arthritis.”
  • Per Genetic Engineering and Biotechnology News,
    • “A cancer drug designed to push malignant cells toward death may also help researchers chip away at one of the toughest barriers to curing HIV: the long-lived viral reservoir that persists despite antiretroviral therapy.
    • “In a study titled, “BCL-2 inhibition at antiretroviral therapy initiation reduces the intact SIV reservoir in macaques,” and published in Nature Microbiology, researchers at Emory University reported that a short course of venetoclax, a BCL-2 inhibitor approved for certain blood cancers, reduced the intact simian immunodeficiency virus (SIV) reservoir in rhesus macaques when given at the start of antiretroviral therapy (ART). SIV infection in macaques is commonly used as a nonhuman primate model for studying HIV persistence and cure strategies.”

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

  • Modern Healthcare reports,
    • “Cambia Health Solutions’ strategic affiliation with Arkansas Blue Cross and Blue Shield has been approved by state regulators.
    • “The deal will take effect Oct. 1, according to a Friday news release from the companies.
    • “Cambia, which operates Regence Blue Cross plans in Idaho, Oregon, Utah and Washington, in February completed a similar affiliation with Blue Cross Blue Shield of North Dakota.
    • “Arkansas Blue Cross will retain its regional brand name, local board and philanthropic foundation, and its reserve funds and foundation resources will stay in the state, according to the news release. 
    • “Curtis Barnett will remain president and CEO of Arkansas Blue Cross, with Jared Short still president and CEO of Cambia, a Cambia spokesperson said Friday. No assets will be transferred.
    • “The affiliation will enable the companies to pool resources and develop new technology and care management services, executives said in November.” 
  • The Wall Street Journal relates,
    • “Most people do not appeal health insurers’ prior authorization denials, even though many who do are successful.
    • “Successful appeals require doctors to provide precise diagnosis details and authoritative medical information to counter insurer objections.
    • “Patients can appeal denials for drugs not on a formulary list or for step therapy requirements by providing medical records.”
  • Beckers Hospital Review tells us,
    • “Lebanon, N.H.-based Dartmouth Health recorded an operating loss of $22.9 million (-2% operating margin) in the third quarter of fiscal year 2026, compared to operating income of $47.7 million (4.3% margin) during the same period last year, according to its Aug. 28 financial report. ” * * *
    • “Dartmouth-Hitchcock Medical Center — its flagship hospital — has implemented a financial resiliency plan aimed at increasing patient access and reducing costs to improve its ongoing operating margin. The system engaged an external consultant in the second half of fiscal year 2026 to accelerate the plan and identify additional margin opportunities systemwide.”
  • Beckers ASC Review informs us,
    • “CMS’ 2026 Hospital Outpatient Prospective Payment System and ASC Payment System Final Rule marked the largest single-year expansion of outpatient-eligible surgery since at least 2018, surpassing, in one year, the 59 procedures Becker’s tracked as added to the ASC-covered list over the entire five-year span from 2018 to 2023. 
    • “Two policy changes drove it: a revision of the ASC covered procedures list criteria, and the start of a three-year phase-out of the inpatient-only list. CMS finalized the addition of 289 surgical procedures to the ASC covered procedures list for CY 2026, and separately added 271 of the codes removed from the inpatient-only list to that same list. Combined, more than 500 procedures became newly eligible for the outpatient/ASC setting in a single year.
    • [The article provides] a breakdown of the newly eligible procedures by specialty.
  • Healthcare Innovation lets us know,
    • “A five-year reimbursement horizon allows health systems to plan and invest in building comprehensive Hospital at Home programs.
    • “Workforce development and training are identified as major challenges, requiring new curricula and integration into the healthcare workforce.
    • “Technology must be designed around patient needs, with passive data capture and seamless EHR integration being key priorities.
    • “Implementation science is crucial to understanding why some programs scale successfully while others remain small.
    • “Hospital at Home is not suitable for all patients; careful patient selection and problem-focused planning are essential for success.”
  • Healthcare Dive points out,
    • “Adena Health has acquired Fairfield Medical Center, months after federal regulators scrutinized its previous planned merger with OhioHealth, the state’s largest health system.
    • “The Federal Trade Commission said Fairfield and OhioHealth scrapped their merger plans after an investigation concluded that a merger between the two systems would violate antitrust guidelines and negatively affect the quality and cost of care.
    • “Now, federal regulators are praising Fairfield’s new deal, which closed on Tuesday. “Today’s announcement should serve as a reminder that we will stop bad hospital deals,” Daniel Guarnera, Director of the Federal Trade Commission’s Bureau of Competition said in a Wednesday statement.”
  • Per Fierce Pharma,
    • “Total prescriptions for Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo both grew over the past week, reaching roughly 181K (+3%) and 44K (+8%), IQVIA data showed, as cited by Citi. Both numbers are the two meds’ highest so far. 
    • “While Foundayo has yet to catch up with the Wegovy pill, the market share gap between the two oral drugs is slowly narrowing. According to an Aug. 28 Jefferies note based on data the previous week, Foundayo’s share of new prescriptions (NRx), which exclude refills, was 21.5% in the oral obesity market.
    • “Back to the most recent week, the Wegovy pill’s position within the Wegovy family remained stable at 35%, as total Wegovy scripts increased 2.7% sequentially to 513.5K. During the same period, Lilly’s Zepbound scripts climbed 1.6% to a little fewer than 772K.” 

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NCQA, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House voted Sept. 1 on a continuing resolution (H.R. 6500) to fund the federal government through Dec. 11. The measure passed on a 370-48 bipartisan vote; the Senate passed its version by a vote of 90-6 on Aug. 8. The CR delays the Office of Management and Budget from finalizing its federal financial assistance proposed rule and prohibits any similar measure from being issued or finalized prior to Dec. 11. The AHA July 13 commented with concerns about the proposed rule, which would revise the Uniform Grants Regulation governing federal financial assistance.”
  • and
    • “The AHA Aug. 31 submitted comments urging the National Association of Insurance Commissioners Health Care Affordability and Mitigation Working Group to take a more comprehensive approach to evaluating healthcare affordability policies in a series of issue briefs being developed as a resource for state regulators and policymakers. The AHA called on the working group to assess consumers’ total financial burden, including premiums, deductibles, cost sharing and access to care, rather than focusing solely on any one measure, such as premium reductions or payer savings. The AHA also encouraged the working group to provide balanced analyses of policy options, including potential tradeoffs and unintended consequences, and to consider how health plan practices, such as prior authorization requirements, claims denials and network design, affect both affordability and patient access to care.”
  • Beckers Hospital Review adds,
    • “Mark Cuban argues the fundamental problem in U.S. healthcare is not whether the system is run by the public sector or the private sector. It is that hospitals do not know what their own services cost.
    • “During an Aug. 18 episode of KFF Health News’ “What the Health?” podcast, the entrepreneur and co-founder of Cost Plus Drug Co. said the lack of granular cost information undermines hospital pricing, reimbursement negotiations and broader debates over healthcare reform.
    • “The fundamental issue is transparency and trust … [and] there are a lot of hospitals that don’t know their costs,” he said. “They just know their cash balance.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today hosted the Live Real Life Symposium at the Hubert H. Humphrey Building in Washington, D.C., bringing together leaders from technology, medicine, research, education, government, and advocacy groups to examine the harms of screen use in children and discuss actionable approaches to supporting healthier childhood development.
    • “Our children get one childhood, and we cannot allow screens to replace the real-world experiences they need to grow and thrive,” said HHS Secretary Robert F. Kennedy, Jr. “Through the Office of the Surgeon General’s Live Real Life initiative, we are giving families practical tools to put technology in its proper place and get children back to playing, exploring, connecting, and experiencing the world around them.”
    • “The symposium is part of the HHS Live Real Life campaign, a national effort to help families, schools, and communities reduce harmful screen use and create more opportunities for children to engage in the experiences essential to healthy development.
    • “The event builds on the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents issued earlier this year, which outlines how factors such as age, content, design, purpose, and duration influence when screen engagement may be beneficial and when it becomes harmful.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $58 million investment is being delivered to improve health outcomes for Hawaiians through the federal Rural Health Transformation Program (RHTP). This investment will strengthen Hawaii’s healthcare 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.”
    • “President Trump made a historic commitment to rural America, and these investments are turning that commitment into better care for patients in communities across Hawaii,” said Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz. “This is what rural health transformation should look like: federal investment that is putting patients first, driving lasting improvements and expanding healthcare for the hardworking Americans who call these communities home.”
  • Reuters relates,
    • “U.S. Centers for Medicare and ​Medicaid Services Administrator ‌Dr. Mehmet Oz said on ​Monday [August 31] that 600,000 ​seniors have signed ⁠up to receive ​GLP-1 weight loss ​medications in the first two months of ​a new ​federal program created to expand ‌access ⁠to the highly sought-after treatments.
    • “Under the so-called Medicare ​Bridge ​program, ⁠which launched in July, ​millions of ​older ⁠Americans qualify for obesity medications at ⁠just $50 ​a ​month.”
  • GAO’s WatchBlog suggests “Nine Ways Congress Can Combat Fraud in the Federal Government,”
  • Fierce Healthcare tells us,
    • “Komodo Health, an AI-powered healthcare intelligence company, is teaming up with the National Committee for Quality Assurance (NCQA) to modernize how healthcare quality measures are developed.
    • “The multi-year strategic partnership will allow NCQA researchers to tap into Komodo’s Healthcare Map, made up of over 330 million de-identified patient journeys, to analyze care across insurance types, care settings and patient populations from a single longitudinal data source. 
    • “They will have access to Komodo’s Marmot, an AI-powered healthcare intelligence platform, to explore complex questions with transparent, reproducible outputs. NCQA is solely responsible for developing HEDIS measures.” * * *
    • “The goal is to allow NCQA to evaluate new measures more quickly and efficiently and to ensure HEDIS reflects real-world evidence. Developing new quality measures has historically required pulling from disparate datasets, including field testing with individual payers and other partners. This could take two to three months, and often had to be done separately for each population studied.
    • “Using Komodo’s Healthcare Map has greatly streamlined that process,” Tricia Elliott, VP of quality implementation at NCQA, told Fierce Healthcare in emailed comments. “Because the Healthcare Map includes insights from Medicare, Medicaid and commercial populations, our researchers can evaluate measures across multiple insurance types using a single, consistent data source rather than running separate analyses.”

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

  • Govexec reports,
    • “Each portfolio within the federal government’s 401(k)-style retirement savings program gained value last month, snapping a two-month streak of lackluster market performance.
    • “The international stocks of the Thrift Savings Plan’s I Fund sported the best performance, gaining 3.32% last month. So far this year, the I Fund has grown 19.18%.
    • “The C Fund, which is made up of large- and mid-size businesses, increased 2.72% in August, good for 13.12% growth since the start of 2026. And the small- and mid-size companies in the S Fund finished August 2.27% in the black, bringing its 2026 gains to 16.10%.”
  • OPM’s Director Scott Kupor added a new post to this Secrets of OPM blog today.
    • “Last week we at OPM recognized excellence among our team members through the Director’s Awards Ceremony.
    • “It not only gave me a chance to put my tuxedo to good use (which I almost never have a chance to do) and to tell the one joke I could remember that’s appropriate for a work setting, but – all kidding aside – it gave us an opportunity to recognize those who have gone above and beyond in service of the American people. And in doing so gave us the opportunity to walk the walk about what a high-performance culture means – one in which we are not afraid to call out individuals and teams that truly exceed expectations and in which we disproportionately reward excellence.
    • “I’ve written about this before (link to WAPO editorial), but the federal government has under-served its employees by trapping them in a system that treats accountability too lightly and fails to reward its top performers. We see this in the historical annual employee ratings systems – where less than 0.5% of a 2 million strong employee base rates below expectations and where nearly every SES (our most senior executives) is rated above expectations. And, as a result, we see this in the annual bonus system which provides little differentiation between satisfactory performance and those who consistently knock the cover off the ball.
    • “We’ve been working to change this culture into one that holds low performers accountable and forces managers to distinguish among their employees based on actual performance – both in ratings and in rewards (link to performance blog). While the Director’s Awards are not a substitute for the traditional end-of-year evaluation cycle, it is a great venue for us to practice what we preach.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Baxter International has recalled one lot each of 70% Dextrose Injection and Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter.
    • “The 70% Dextrose Injection may contain stainless steel particles, according to an Aug. 25 FDA alert. The affected product is lot Y495066, which expires July 31, 2027. It was distributed July 25-28, 2026, to healthcare providers and distributors in select states, including Alabama, Georgia and Tennessee.
    • “Baxter also recalled lot Y493475 of Anticoagulant Sodium Citrate Solution due to the potential presence of fiberglass. The product, which expires Dec. 31, 2027, was distributed July 2-11, 2026, to one customer in the U.S.” * * *
    • “As of Aug. 25, Baxter had not received any reports of adverse events related to either issue. Customers were instructed to immediately discontinue use of affected units and return them.”
  • Oncology News Central relates,
    • “On Aug. 31, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft (Besremi) for adults with essential thrombocythemia (ET), marking the first approval for the rare blood cancer in nearly three decades.
    • “Regulators based their decision on results from the open-label, multicenter, randomized SURPASS ET clinical trial. The phase 3 study enrolled 174 adults with ET who had an inadequate response to hydroxyurea. 
    • “Today’s FDA approval of [ropeginterferon alfa-2b] for ET is a significant advancement for patients and reflects PharmaEssentia’s longstanding commitment to advancing innovative therapies for people living with myeloproliferative neoplasms,” PharmaEssentia CEO Ko-Chung Lin, PhD, said in a statement. “We have been working closely with the FDA, healthcare providers, advocacy organizations, and payers to bring this important treatment option to the ET community.”
  • STAT News lets us know,
    • “Medical device giant Stryker earlier this summer received Food and Drug Administration authorization for a surgical display system using Apple’s Vision Pro headset. Specifically indicated for imaging during minimally invasive surgery for hip impingement and labral repair, SportSuite Vision allows a surgeon to place multiple displays that are usually scattered around an operating room in their preferred configuration in the Vision Pro’s display. During a procedure, surgeons usually need to swivel their heads and bodies to refer to CT imaging, arthroscopic video, and Stryker software.
    • “The De Novo authorization was based on hundreds of hours of lab testing, including work on cadavers and testing interactions with other staff, but the company is announcing today that a surgeon at Duke Health completed a real procedure using the technology.
    • “Matt Moreau, VP and general manager of sports medicine at Stryker, told me the company has long wanted to create such a “surgical cockpit,” but Vision Pro is the first to deliver on the technical capabilities necessary, including  high-quality passthrough video that allows a surgeon to see the operating room and staff around them.”

From the judicial front,

  • “A panel of three Republican judges (two Trump first term appointees and one George H.W. Bush) from the U.S. Court of Appeals for the 11th Circuit unanimously overruled a district court decision holding the False Claims Act’s qui tam provision unconstitutional.  Here is an 11th Circuit link to the opinion.”
  • In short this is the Court’s holding:
    • “Here, a relator brought an FCA suit against defendants that she alleged committed Medicare fraud, and the defendants moved for judgment on the pleadings or dismissal on the grounds that the qui tam provisions violated the Constitution’s Appointments Clause, Take Care Clause, and Vesting Clause. The district court granted the defendants’ motion and held that the qui tam provisions violate Article II’s Appointments Clause because relators qualify as officers of the United States and, as such, must be (but are not) presidentially appointed.
    • “We disagree and hold that relators are not officers of the United States because they do not occupy a continuing position established by law. Accordingly, we join our sister circuits that have addressed this issue and hold that the qui tam provisions of the FCA do not violate the Appointments Clause. Therefore, we vacate the district court’s order dismissing this case and remand for the district court to evaluate the defendants’ remaining constitutional arguments.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “COVID-19 cases are ticking up in almost every U.S. state as summer draws to a close, according to the latest data from the Centers for Disease Control and Prevention.
    • “COVID-19 activity was still categorized overall as “very low” nationwide by the agency as of Aug. 28, though cases are consistently increasing. This is likely the result of what has come to be known as the “summer surge,” a pattern that doctors have observed each year since around 2022. Unlike other respiratory illnesses such as the flu, COVID-19 tends to flare not only during the typical winter cold and flu season, but also toward the end of summer.
    • “Experts previously told USA TODAY that this is likely caused by multiple factors, including behavioral and environmental changes (the amount of time spent cooped up in AC, going back to school, etc.), as well as the virus’s life cycle and how our immunity to it waxes and wanes.
    • “COVID-19 is rising nationally but from a low baseline,” Dr. Syra Madad, infectious disease epidemiologist at Harvard’s Belfer Center and chief biopreparedness officer for New York City’s public hospitals, previously told USA TODAY. “The increase became apparent in parts of the South and West during July and more clearly nationwide by late July and early August.”
  • Beckers Behavioral Health relates,
    • “The CDC predicts 67,798 drug overdose deaths in the U.S. during the 12 months ending in March 2026, a 12.3% decrease compared to the same time period in the previous year, according to an Aug. 31 news release from the agency.”
  • NPR tells us,
    • “Maria Uloko sees the same scenario in her urology practice in Los Angeles every day: A woman has been diagnosed with recurrent urinary tract infections (which means she’s had at least two in six months or three in a year), taken repeated rounds of antibiotics, and feels confused as to why the infections keep coming back.
    • “Then, Uloko tells these patients something that often feels both revelatory and frustrating. “Most of them don’t actually have UTIs, even though that’s been their diagnosis time and time again,” she says. “In fact, millions of women are being treated for UTIs they may not actually have.”
    • “Uloko is the co-author of a recent study published in The Journal of Sexual Medicine that backs this up. She and her fellow researchers reviewed the medical records of 253 women with recurrent UTIs and found that just 15% showed evidence of problems that were limited to the bladder or urinary tract. The remaining 85% had signs of hormonally driven inflammation of the vulvar region and 75% had pelvic floor dysfunction.
    • “These conditions produce identical symptoms as UTIs — burning with urination, urgency, frequency, and/or lower abdominal pain — but require different treatment.
    • “What we found is that in women with recurrent UTIs, the majority didn’t have a bladder problem at all; they had a vulvar problem,” says Uloko.”
  • STAT News informs us,
    • “New guidelines released Monday highlight the many new treatments that have hit the market in recent years for the prevention of migraine. 
    • “The guidance for health care providers comes from the American Headache Society and the American Academy of Neurology, which last updated their recommendations in 2012. 
    • “There has been a wealth of new treatment available,” said Rebecca Burch, guideline co-author and neurologist at the University of Vermont Medical Center. Burch also co-authored the previous guidance. 
    • “Among the key updates are at least a half dozen medications that were approved for migraine prevention by the Food and Drug Administration since 2012. Many of those focus on blocking the calcitonin gene-related peptide, or CGRP, pathway, which is implicated in migraine. 
    • “The new guidelines advise doctors to offer preventive treatment to people who have at least four migraine or severe headache days per month, or whose migraines interfere with their ability to work or complete daily tasks. An estimated 15% of Americans experience migraines, with women disproportionately affected. Many try to manage their pain with over-the-counter options once an attack has begun.” 
  • Health Day points out,
    • “Adults who spend hours scrolling social media every day are more likely to develop depression, a new study says.
    • “Around 2.5 hours or more of scrolling per day is linked to self-reported depression, researchers recently reported in the journal npj Mental Health Research.
    • “The study found that social media is more closely linked to depression than other factors like your job, your educational background, or your time spent playing video games, surfing the web or watching TV, researchers said.
    • “It’s a damning picture. Social media is harmful for individuals across the lifespan,” senior researcher Hans Breiter, a professor at the University of Cincinnati, said in a news release.
    • “We should not subject ourselves to a product using addiction science to optimize our viewing time,” Breiter said.”
  • Per Reuters,
    • “People taking popular GLP-1 obesity drugs who remain on low starter doses will ​lose some weight but may still experience side effects, although significantly less nausea than those who graduate ‌to higher manufacturer-recommended doses, a new study suggests.
    • “And they are unlikely to experience the double-digit weight-loss percentages seen with the higher doses, the study found.
    • “The GLP-1 drugs semaglutide, sold as Ozempic and Wegovy by Novo Nordisk (NOVOb.CO), and Eli Lilly’s (LLY.N) tirzepatide, sold under the brand names Mounjaro and Zepbound, are prescribed ​initially at a low dose followed by gradual titration to higher doses, to help the body adjust and minimize side ​effects.”
  • Cardiovascular Business notes,
    • “Catheter ablation does not significantly improve the quality of life of patients with symptomatic atrial fibrillation (AFib) more than a sham procedure involving sedation, venous access and electrical cardioversion, according to new late-breaking data presented at ESC Congress 2026. The findings were simultaneously published in The Lancet.[1]
    • “PVI-SHAM-AF was a randomized, double-blind, sham-controlled trial included more than 250 patients with symptomatic paroxysmal or persistent AFib. Patients were randomized to undergo either catheter ablation or a sham procedure. The sham procedure was rather complex, involving sedation, venous access, time in the electrophysiology lab and even cardioversion. Each participant completed an AF Effect on the Quality of Life Questionnaire (AFEQT) at baseline and again after six months. 
    • “Overall, 173 patients were treated with catheter-based pulmonary vein isolation (PVI) ablation and another 89 patients were treated with the sham procedure. After six months, AFEQT scores improved from 61.3 to 81.1 in the catheter ablation group and from 59.2 to 74.9 in the sham procedure group. This was not viewed as a significant difference. 
    • “On the other hand, the authors noted that catheter ablation was still proven to be effective in reducing the risk of recurring episodes of AFib. Freedom from AFib after six months occurred in 73% of catheter ablation patients and 52% of sham procedure patients.”
  • and 
    • “Metformin, a popular type 2 diabetes medication used to reduce blood glucose levels, does not appear to make a significant impact on outcomes for patients with heart failure with reduced ejection fraction (HFrEF). That is according to two separate studies presented at European Society of Cardiology (ESC) Congress 2026.
    • “The first of the two studies, Met-HeFT, included 940 heart failure patients in Denmark who either presented with type 2 diabetes or face an increased risk of developing type 2 diabetes. The mean age was 70 years old, and 84% of patients were men. Study participants were randomized to either undergo treatment with metformin or a placebo.
    • “Overall, after a mean follow-up period of 3.7 years, there was no significant difference in the study’s primary endpoint—a composite of mortality, worsening heart failure symptoms, acute myocardial infarction or stroke—between the two groups. That outcome occurred in 25.1% of metformin patients and 23.4% of placebo patients. Secondary endpoints, including new-onset diabetes and unplanned heart failure rates, were also not significant different between the two treatment options.
    • “It is worth noting, however, that just approximately one in 10 patients presented with type 2 diabetes. The remaining patients were all determined to face a heightened risk of developing type 2 diabetes.”
  • BioPharma Dive adds,
    • “A pill developed by Novartis succeeded in a pair of Phase 3 trials in people with a common form of multiple sclerosis, bolstering confidence in the drug’s prospects and sending company shares up by over 4% on Tuesday.
    • “The Swiss pharmaceutical giant didn’t provide detailed study results. Still, Novartis revealed the therapy, remibrutinib, demonstrated “superiority” over the drug Aubagio in reducing yearly relapse rates and inflammatory brain lesions in study participants. Treatment was associated with “clinically meaningful” effects on disability progress and, notably, didn’t impact liver safety — an issue for multiple drugs in remibrutinib’s class. 
    • “The findings could position remibrutinib, which is already approved as Rhapsido for chronic skin hives, to become a bigger sales contributor in the future. Novartis is looking to remibrutinib and other late-stage prospects to offset revenue losses from multiple patent expirations. It intends to share the MS study results with health regulators.” 
  • and
    • “An experimental drug Alumis has been testing in a form of lupus failed a mid-stage study, but the company will press forward after observing positive signs in a subgroup of trial participants.
    • “According to Alumis, the drug, envudeucitinib, missed all of its main and secondary objectives in systemic lupus erythematosus. Still, “robust” responses were seen in trial volunteers with “high interferon gene signature,” meaning certain genes controlled by interferons are overexpressed. A majority of people with moderate-to-severe SLE fit this description, Alumis said.
    • “Alumis will meet with regulators to discuss a path toward a Phase 3 trial. Company shares plummeted by nearly 55% on the results, though, nearly erasing all of Alumis’ stock gains this year. The company’s market value had soared following positive results in psoriasis in January.” 

From the U.S. healthcare business front,

  • Beckers Payers Issues calls attention to the following:
    • “Several of the nation’s largest health insurers rolled out reimbursement policy changes Sept. 1, ranging from new lab testing coverage limits at UnitedHealthcare to a billing overhaul at Blue Cross Blue Shield of Michigan that has drawn pushback from providers.”
  • and 
    • “UnitedHealthcare has released the specific procedure codes it will exempt from prior authorization as part of the insurer’s previous pledge to reduce requirements by 30% before the end of 2026.
    • “The code lists cover 1,700 procedure codes for a range of services across commercial, Medicare Advantage, individual exchange, and Medicaid plans. Effective Oct. 1, providers will no longer need to seek the insurer’s approval for many outpatient procedures, including lesion excisions, fracture treatments, joint injections, arthroscopies, colonoscopies, endoscopies, biopsies, hernia repairs and soft tissue tumor removals. Genetic and molecular testing codes also make up a large  portion of the lists.
    • “UnitedHealthcare CEO Tim Noel said in May that prior authorization “should only be used when it truly protects patients and improves care.” At the time, the insurer said it requires prior approval for just 2% of its medical services, with roughly 92% of submitted requests approved in less than 24 hours on average. The 30% reduction builds on an earlier 20% cut to commercial prior authorization requirements in 2023.”
  • HR Dive reports,
    • “Despite the current economic turbulence, most employees in a majority of companies will be getting a base salary increase for 2027, according to a large survey by Korn Ferry.
    • “Almost half (47%) of the 5,512 participating employers said they expect to provide salary hikes to at least 95% of their employees, while 79% expect to do so for at least 80% of employees. Only 2% said they are planning no increases for anyone.
    • “U.S. organizations expect to boost overall base-salary budgets next year by an average of 3.3% and a median of 3%. The median increase for U.S. executive and senior management is also anticipated to come in at 3.0%. 
    • “The survey was conducted in June of this year.”
  • Fierce Pharma unveiled its Fierce 50 awardees of 2026.
  • Beckers Hospital Review tells us,
    • “Philadelphia-based University of Pennsylvania Health System recorded operating income of $336.9 million (2.5% operating margin) for fiscal year 2026, up from operating income of $246.7 million (2.1% margin) during the same period last year, according to its Aug. 28 financial report.”
  • and
    • “Boston-based Dana-Farber Cancer Institute posted an operating loss of $9.1 million (-0.9% margin) in the third quarter of fiscal 2026, compared with an operating loss of $2.6 million (-0.3% margin) in the same quarter last year, according to its Sept. 1 financial report.”
  • and
    • “From R1 RCM striking an agreement to acquire an AI-powered touchless prior authorization company to IKS Health acquiring TruBridge, [the article identifies] 12 revenue cycle company mergers and acquisitions that have been announced or completed since March 17.”
  • Beckers Clinical Leadership informs us,
    • “Single specialty and multi-specialty groups were the top two highest-paying settings for physicians, followed by hospitals, Doximity found. 
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of nearly  23,000 responses collected in 2025, according to a company news release.  
    • “Among settings, solo practice had the largest drop in compensation year-over-year at -3.8%, while urgent care centers had the highest growth for the second year in a row, the report said.” 
  • and
    • “Most physicians say they’d still choose medicine if they had it to do over again, but nearly half say they’re likely to leave clinical practice within the next two years, according to Doximity’s 2026 Physician Compensation Report.
    • “Doximity, a digital platform for U.S. medical professionals, released the report Aug. 25. The findings are based on a survey of physicians conducted in June on how AI is changing physician careers and pay, along with salary data from more than 23,000 physicians collected in 2025, according to a company news release.”
  • MedTech Dive notes,
    • “Medtronic kicked off its fiscal year with double-digit revenue growth, building on momentum the company posted coming out of its previous year.
    • “Medtronic grew revenue by 13.7% to $9.8 billion in its fiscal first quarter, fueled by double-digit growth in its cardiovascular and medical surgical businesses. The strong quarter prompted the company to increase its organic revenue growth forecast for the full fiscal year.
    • “Importantly, these results reinforce our confidence and the durability of our business,” CEO Geoff Martha told investors on a Tuesday earnings call.
    • J.P. Morgan analyst Robbie Marcus wrote in a note to investors that Medtronic beat Wall Street’s consensus expectations in sales by about $220 million in the quarter.
    • “Much like in the fourth quarter, Medtronic’s cardiovascular unit was a bright spot for the company. The business brought in $3.93 billion in revenue, representing nearly 20% growth year over year.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Beckers Hospital Review reports,
    • “CMS said its enforcement efforts have resulted in blocking more than $1.6 billion in possibly improper Medicare lab payments throughout President Trump’s administration.
    • “An Aug. 28 CMS news release said these enforcement actions included savings of $732 million from 157 providers with revoked Medicare privileges, and a CMS investigation of 600 labs that resulted in 185 payment suspensions with more than $500 million in potentially fraudulent payments stopped. There were also 85 law enforcement referrals from a contractor that led to the prevention of $127 million in possibly fraudulent payments, and there was a recoupment of more than $276 million from 442 flagged overpayments to suspect labs.
    • “CMS had been using AI, among other analytics tools, to mine original Medicare claims. CMS focused on several kinds of lab fraud, such as labs billing for up-coded services. The news release said lab fraud can take place across services, including pathogen detection, high-complexity drug tests and genetic testing.
    • “Since the start of 2026, the CMS Fraud Defense Operations Center has been responsible for more than $371 million in Medicare suspended payments implicating 267 providers and suppliers.
    • “The news release comes amid CMS’ broader anti-fraud push across government programs, including Medicaid.”
  • FEHBlog observation — I find it hard to believe that these scoundrels would similarly attach FEHB plans for which private carriers hold the risk.
  • Beckers Payer Issues relates,
    • “The Labor Department is proposing a rule that would set criteria for employer associations to sponsor association health plans that qualify as employee welfare benefit and group health plans under the Employee Retirement Income Security Act.
    • “Received by the Office of Information and Regulatory Affairs Aug. 11, the rule is under review. ERISA outlines minimum standards for employee benefit plans.”
  • Beckers Behavioral Health adds,
    • “The Drug Enforcement Administration has submitted a final rule on telehealth prescribing of controlled substances to the White House for regulatory review.
    • “The DEA filed the rule Aug. 25 and listed it as “economically significant,” an Office of Management and Budget designation reserved for regulations expected to have an annual economic impact of at least $100 million.
    • “The rule would establish a long-promised special registration pathway allowing DEA-registered practitioners to prescribe controlled substances, including medications for opioid use disorder and attention-deficit/hyperactivity disorder, via telemedicine. It follows a proposed version of the rule that drew more than 6,400 public comments and would replace a series of temporary extensions the DEA has issued since pandemic-era flexibilities suspended the in-person visit requirement for such prescriptions. The agency’s latest extension of those temporary flexibilities runs through Dec. 31, 2026.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services’ six-month moratorium on the enrollment of new durable medical equipment, prosthetics, orthotics and supply companies in Medicare expired Aug. 27. CMS said that national provider enrollment contractors have resumed accepting initial enrollment applications from those suppliers. The agency said that suppliers should submit applications as soon as possible to allow contractors the maximum time for processing before the bidding window opens for the 2028 round of the DMEPOS Competitive Bidding Program.”
  • NCQA informs us,
    • “To align with the industry’s transition to digital quality measurement and the need for more streamlined data exchange, NCQA is creating a new HEDIS® measure for Transitions of Care (TRC) that uses the Electronic Clinical Data Systems (ECDS) reporting methodology.
    • “The current TRC measure assesses performance through a hybrid reporting methodology that combines administrative claims data and medical record review for a sample of eligible members. Because the hybrid TRC measure is included in the CMS Medicare Star Ratings, NCQA is coordinating this effort with CMS and other stakeholders.
    • “This measure is important because it evaluates care transitions, which present opportunities for missed connections that often require patients and families to fill in the gaps,” says Fern M., Director of Digital Quality Informatics at NCQA. “We know that health plans, technology vendors and policymakers are heavily invested in this measure, so we want to be as transparent as possible and allow organizations enough time to prepare for the changes.”
    • “The earliest implementation of the new ECDS TRC measure would be Measurement Year (MY) 2028, with the intention of retiring the hybrid version of the TRC measure in MY 2029.”

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

  • Govexec reports,
    • “Most federal employees would see their pay frozen at 2026 levels next year under an alternative pay plan issued by President Trump this week, though for the second straight year, federal law enforcement officers would receive a 3.8% increase.
    • “Trump first proposed the pay freeze as part of his fiscal 2027 budget proposal. Though the document was silent on federal employee compensation, officials with the Office of Management and Budget quickly clarified that its omission equated to a planned freeze for 2027.
    • “In a letter to House Speaker Mike Johnson, dated Thursday, Trump said increasing most federal employees’ pay would be “unacceptable and unfair” given the inflation that occurred under the Biden administration. Inflation actually has risen from 2.8% when former President Biden left office to 3.3% as of last month.
    • “I have therefore decided to set at zero the pay adjustment to be made for the 2027 pay year,” Trump wrote. “This decision will maintain fiscal responsibility without harming the government’s ability to recruit and retain well qualified employees.”
    • “But in the next paragraph, Trump said that for the second straight year, he instructed the Office of Personnel Management to issue a 3.8% increase in basic pay to federal law enforcement personnel next year, “to increase recruitment and retention” in those roles.”
  • Federal News Network adds,
    • “Up to 400 federal positions can now earn salaries of $400,000. A new final rule from the Office of Personnel Management allows the higher pay rates for hundreds of workers under an authority known as “critical position pay.” The authority is meant to help agencies recruit and retain highly qualified and specialized government workers in mission-critical roles. OPM’s final rule this week aligns with President Donald Trump’s orders earlier this year to use the pay authority for up to 400 national security roles.(Final rule on critical position pay authority – Office of Personnel Management)”
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Squawk Box on CNBC to discuss the Trump Administration’s efforts to recruit top tech talent and advance his vision for a more tech-driven federal government.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about an ongoing safety issue with certain intravascular catheters manufactured by Boston Scientific. These devices are being removed from the market, and Boston Scientific has officially decided to discontinue them going forward.
    • “The devices in question are Boston Scientific’s single-use Imager II Angiographic Catheters, which interventional cardiologists, vascular surgeons and interventional radiologists use to capture images of a patient’s peripheral vasculature. They are available in a variety of shapes and lengths. 
    • “This warning, which covers all Imagers II Angiographic Catheters, was put in place due to a manufacturing defect that can cause the catheter tip to degrade or detach from the rest of the device.”
  • MedTech Dive adds,
    • “Medtronic has recalled a pH monitoring capsule over a risk linked to 184 serious injuries, the Food and Drug Administration said Thursday.
    • “The recall, which the FDA communicated in an early alert notice, affects Bravo CF capsules that pose risks including perforation of the esophagus, obstruction of the airway and blood loss.
    • “Medtronic withdrew a subset of the newly recalled Bravo CF lots last year. The FDA said the same failures triggered both recalls, but the underlying causes of the problems are different.”
  • Fierce Pharma relates,
    • “In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk.
    • “On Friday, Lilly checked another item off that list as it secured FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE), including CV death, heart attack or stroke, in at-risk adults with Type 2 diabetes. With the nod, Lilly matches the 2020 approval Novo received for its diabetes treatment, Ozempic, to lower the risk of adverse cardiovascular events in at-risk patients.
    • “The label expansions came on similar timelines for the rivals. While Novo achieved its heart-helping endorsement three years after the FDA originally approved Ozempic, Lilly gained its expansion four years after the FDA first signed off on Mounjaro.”
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells. The excess cells can thicken the blood and increase the risk of cardiovascular issues, such as blood clots, stroke and heart attack.
    • “Mimrylo offers a new treatment approach for patients whose disease has not been adequately controlled with existing therapies. It is the first approved treatment for polycythemia vera that mimics hepcidin, a hormone that naturally regulates iron in the body. By limiting the iron available to make new red blood cells, Mimrylo helps reduce their overproduction and keep red blood cell levels under control. This novel approach offers a new option for patients who have not achieved adequate control with existing therapies.

From the judicial front,

  • Per a Department of Justice news release,
    • “The Justice Department, together with the Drug Enforcement Administration (DEA), today announced a $50 million settlement with Walmart Inc. (Walmart) to resolve allegations that Walmart pharmacies illegally filled thousands of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA).” * * *
    • “The government’s complaint — filed on Dec. 22, 2020, and amended in 2022 in the U.S. District Court for the District of Delaware — alleged that since June 26, 2013, Walmart filled invalid prescriptions through the knowing actions of individuals on its compliance team and the knowing actions of its pharmacists. * * *
    • “In addition to the monetary payment announced today, Walmart has entered into a memorandum of agreement with DEA to address its future obligations in dispensing controlled substances. This agreement requires Walmart to establish a hotline for both employees and patients to report suspected illegal dispensing of controlled substances, proactively monitor the dispensing patterns of its pharmacies to identify and address potentially illegal dispensing, and establish a process to evaluate prescribers suspected of illegal prescribing.” * * *
    • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“
  • STAT News adds,
    • “A U.S. appeals court [panel for the 5th Circuit] ruled the Food and Drug Administration went through the proper process when it declared Novo Nordisk and Eli Lilly’s diabetes and obesity drugs are no longer in shortage, Bloomberg Law notes. The order is a loss for the Outsourcing Facilities Association, which representing large-scale compounders and challenged FDA decisions in the last two years that shortages ended for Novo’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound. That declaration restricted compounders from legally mass-producing versions of the drugs.”

From the public health and medical / Rx research front

  • The Center for Disease Control and Prevention announced today,
    • “As of August 28, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “National and regional COVID-19 activity is increasing. 
    • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
  • The American Journal of Managed Care reports,
    • “Children and young adults who were unvaccinated and infected with COVID-19 were at an increased risk of developing myocarditis, pericarditis, and mortality when compared with those who were vaccinated against COVID-19 with the Pfizer-BioNTech vaccine and not infected.1
    • “The recent findings published in Vaccine underscored the BNT162b2 vaccine’s favorable benefit profile, particularly for children and young adults. Prior research, also published in Vaccine, described COVID-19 vaccinations in general as reducing the risk of severe or prolonged disease—such as long COVID—in adolescents.2 These data, in tandem with the more recent study, provide ample evidence supporting preventive action against COVID-19 for children and adults.” 
  • The University of Minnesota CIDRAP adds,
    • “Giving children antiviral drugs within the first two days of the onset of flu symptoms reduces their likelihood of hospitalization by 81%, a study published last week in Pediatrics finds. 
    • “This protective effect remained robust among children aged 5 years or younger,” wrote the authors, led by scientists at Hsinchu Municipal MacKay Children’s Hospital in Taiwan.” * * *
    • “In an accompanying commentary, James Antoon, MD, PhD, MPH, and Kathryn Edwards MD, both of Vanderbilt University, noted that some pediatricians seem reluctant to use antivirals, adding that about 40% of high-risk pediatric flu patients go without them. 
    • “They urged more widespread use of the drugs. “The time has come for antivirals to be used in children with influenza,” they said. “With greater public hesitancy regarding vaccines, declining seasonal influenza vaccination rates, and recent influenza seasons with record pediatric deaths and hospitalizations, providers should strongly consider the use of antivirals in high-risk and hospitalized patients.” 
  • and
    • “Pennsylvania continues to see numbers climb in its ongoing measles outbreak, with 86 new cases added this week, which brings the total number of cases to 460 with 83 hospitalizations, according to an update today of the state’s measles dashboard. None of the cases have occurred in fully vaccinated people.” * * *
    • “For the third week in a row, Utah, which had the largest measles outbreak, reported no new cases. The state’s tally remains at 518. 
    • “The Georgia Department of Health confirmed four cases of measles linked to a daycare in the Atlanta area, with cases occurring in children who were unvaccinated or had not received the full measles, mumps, and rubella (MMR) vaccine series. 
    • “While the Centers for Disease Control and Prevention (CDC) typically update their measles numbers on Friday, a notification said the August 28, 2026, data have been delayed but will be updated as soon as possible. As of August 20, 2026, the CDC said there were 2,777 cases of measles in 47 states. Of those cases, 94% have been in unvaccinated individuals.”
  • Healio relates
    • “Rates of substance use fell among adolescents and young adults across most substances between 2021 and 2025, even as marijuana use increased among adults aged 26 years and older, according to the 2025 National Survey on Drug Use and Health.
    • “Substance use began declining among children aged 12 to 17 years prior to the COVID-19 pandemic, and those trends seem to be continuing among young adults aged 18 to 25 years in the new data, said Chris Jones, PharmD, DrPH, MPH, director of the Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration (SAMHSA).
    • “Coupling that with other surveys that show downward trends, that seems to be a durable effect that we’re seeing in recent years,” Jones told Healio.”
  • Cardiovascular Business tells us,
    • “Patients with peripheral artery disease (PAD) face a significantly higher risk of developing new-onset atrial fibrillation (NOAF), according to a new meta-analysis published in JACC: Advances.[1]
    • “The study’s authors reviewed data from more than 1,500 studies, landing on seven they wanted to focus on for this research. All studies were associated with a low risk of bias. The oldest study was performed in 2013 and the most recent was performed in 2022. All five studies were observational; five were prospective and the other two were retrospective. One study enrolled only women.
    • “In total, this meta-analysis included data from 763,919 patients. Approximately 56,000 of those patients had PAD as determined by ankle-brachial index (ABI) or a clinical diagnosis. In addition, there were approximately 26,000 cases of NOAF during follow-up. 
    • “Overall, researchers noted, PAD was linked to a 34% higher risk of developing NOAF. The hazard ratio was 1.34.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “Researchers at the University of Toronto have developed a next-generation RNA therapeutic strategy that could have the potential to treat a wide range of genetic diseases that share certain types of disease-causing mutations. The team showed that chemically enhanced suppressor transfer RNAs (sup-tRNAs) combined with a lung-targeted delivery system can restore production of a critical protein in models of cystic fibrosis (CF) caused by “nonsense mutations.”
    • ‘These mutations introduce a premature stop signal into the genetic instructions for making a protein. The result is that cells may produce little or no full-length functional protein, disrupting vital functions in ways that are difficult to treat.
    • “The researchers, led by Bowen Li, PhD, an associate professor in U of T’s Leslie Dan Faculty of Pharmacy, engineered sup-tRNAs to help cells read through these premature stop signals introduced by nonsense mutations into the mRNAs, and complete production of full-length proteins that would otherwise be truncated or absent. They tested the approach in bronchial epithelial cells, mouse models, and patient-derived cystic fibrosis organoids and found that the chemical modifications increased the readthrough of premature termination codons and tRNA aminoacylation, prolonged the tRNAs’ functional activity, and reduced innate immune activation. Moreover, the approach restored CFTR protein production and function across cell, animal, and patient-derived organoid models. The researchers also found that the approach can be combined with existing cystic fibrosis drugs, suggesting the potential for combination therapy.”
  • The New York Times points out,
    • “A one-time gene-editing treatment to lower cholesterol had long-lasting effects a year later, scientists reported on Friday. The results highlight the potential to treat even common diseases by altering people’s genes.
    • “In the small study, which followed only 15 patients, participants who got the highest dose saw their cholesterol levels plunge by half — and stay that way for a year. The results were presented at the European Society of Cardiology Congress and published in the New England Journal of Medicine.
    • “Earlier this year, a similar “one-and-done” clinical trial that used a different gene-editing approach also reported significantly reduced “bad” LDL cholesterol in 35 patients.
    • “Both efforts are early safety studies and are years away from becoming an option people will be offered in a doctor’s office. But an approach that once seemed almost outlandishly far out has inched closer to reality as evidence accrues that it works, and that the results stick.”

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

  • Beckers Hospital Review reports,
    • “Health system CEOs are navigating a growing list of financial pressures, including Medicaid coverage and reimbursement changes under HR 1 and ongoing payment and policy challenges surrounding the federal 340B drug discount program. Site-neutral payment adds another consideration as health systems weigh where to invest and deliver care. 
    • “At Winchester, Va.-based Valley Health, concerns about site-neutral payment are already influencing where the system adds outpatient capacity. President and CEO Mark Nantz said Valley Health is keeping new outpatient sites on its hospital campuses in part to preserve hospital outpatient department rates. Peter Slavin, MD, president and CEO of Los Angeles-based Cedars-Sinai, said eliminating the outpatient payment differential entirely could cost Cedars-Sinai Medical Center about $200 million annually. J. Stephen Jones, MD, president and CEO of Fairfax, Va.-based Inova, said the policy has not changed where the system invests, but it has prompted greater focus on site of care when evaluating projects.
    • “It disrupts the financial model that includes things like 340B, hospital outpatient department rates and Medicare disproportionate share,” Mr. Nantz told Becker’s. “All of those things together help us cobble together a pretty fragile financial model. And so if any part of that financial model, somebody starts pulling the string on it, it unravels pretty fast.”
  • Beckers ASC Review lets us know,
    • “Hospital-employed physicians command significantly higher commercial reimbursement rates than independent peers across every specialty, with a $92 average gap in blended evaluation and management rates in the Chicago market, and the cost difference extends well beyond the professional fee, according to 2026 Trilliant Health price transparency data.
    • “Employed urologists averaged $263 per blended E/M visit compared with $141 for independent urologists, a $122 gap. Employed gastroenterologists averaged $240 versus $141 for independents, employed orthopedic surgeons averaged $260 versus $154, and employed cardiologists averaged $234 versus $144. Even the smallest gap, primary care at $196 employed versus $154 independent, represents a 27% premium for identical services.
    • “The stakes are significant given how many physicians have moved into hospital employment. Approximately 253,000 physicians became employees of hospitals or corporate entities between January 2018 and January 2026, and 79.5% of physicians who sold their practices to a hospital or health system cited the ability to negotiate higher payment rates as an important or very important reason for doing so.”
  • Per Beckers Physician Leadership,
    • “More than 60% of physicians are not satisfied with how the medical profession deals with work-life balance, according to a new report from Medscape. 
    • “State of the Medical Profession Index Report 2026,” published Aug. 28, surveyed more than 1,000 physicians across 29 specialties to rate their satisfaction with how the profession is dealing with key issues, and their optimism levels for improvement going forward.” 
  • Healthcare Dive relates,
    • “Virtual healthcare company Sword Health is planning to acquire digital mindfulness company Headspace, according to a regulatory filing.
    • “Headspace’s parent company OrangeDot is seeking to be acquired by Sword in an all-cash deal, the company told regulators in Massachusetts on July 22.
    • “The acquisition is expected to close on Sept. 14. The financial terms of the deal were not disclosed. Neither Headspace nor Sword Health responded to a request for comment by publication time.”
  • Managed Care Executive tells us,
    • “Cancer biosimilars are associated with lower costs for both insurers and patients, according to a new study by researchers at the UCLA Health Jonsson Comprehensive Cancer Center. Patients with cancer who exclusively used biosimilars had average monthly costs that were $3,820 lower for insurers and $39.50 lower out-of-pocket costs compared with patients who exclusively used the branded biologic drugs, according to a study published today in JAMA Oncology.“
    • “Although the savings were substantially greater for insurers than for patients, even modest reductions in out-of-pocket costs may be meaningful for people facing the financial challenges of cancer care,” senior author Tina Shih, Ph.D., director of the Cancer Health Economics Research Program at the UCLA Health Jonsson Comprehensive Cancer Center, said in a news release. Shih is also a professor of Health Economics in the Department of Radiation Oncology.”
  • Fierce Pharma informs us,
    • “Twenty weeks into its launch, Eli Lilly’s Foundayo has finally exceeded 40,000 in weekly prescriptions, according to IQVIA data cited by Citi. The oral GLP-1 drug posted 40,862 scripts last week, bouncing back from a small dip the week prior. Still, the drug’s scripts level is no match for the roughly 57K that Novo Nordisk’s Wegovy pill garnered at week 6 of its own launch.
    • In its 33rd week of launch, the Wegovy pill booked roughly 175K scripts, slightly down from 176K, per IQVIA. The share of the oral version of semaglutide in all Wegovy obesity scripts was flat week over week at 35%. All told, across the pill and the injectable, Wegovy’s weekly scripts were a little over 500K, down 0.8% sequentially.
    • “As Jefferies analysts observed in an Aug. 21 note, Wegovy has been relatively flat since the Medicare GLP-1 Bridge program began July 1.
    • “Overall, the roughly 60%-40% obesity market share split between Lilly and Novo remained stable, as Lilly’s Zepbound held its ground as the most popular drug.”

Weekend update

David Ermer–Congress, COVID-19, FDA, Obesity, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • This is the last week that both Houses of Congress are out of town on State/District work period. The House of Representatives returns to Capitol Hill on August 31 and the Senate returns on September 14. Both Houses head out on the campaign trail on October 1 until the week following the national election day on November 2.
  • Global BioDefense reports,
    • “The federal government wants to lock in vaccine manufacturers now, well before the next flu pandemic arrives, rather than scramble to build production capacity after one begins. The Biomedical Advanced Research and Development Authority (BARDA) released a request for proposals on August 17 seeking companies to maintain what the agency calls warm base manufacturing capacity for pandemic influenza vaccines, a standing readiness posture that keeps production lines, seed stocks, and regulatory groundwork in place so doses can start flowing quickly once a pandemic strain emerges.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “After receiving Europe’s CE mark earlier this year, Abbott is preparing to bring a dual glucose-ketone sensor to the U.S.
    • “The company has filed an application for its new device, called Libre Duo, with the Food and Drug Administration, with expectations for approval before the end of the year.
    • “Abbott hopes that by allowing people to be more aware of ketone levels, the new device will help prevent diabetic ketoacidosis, or DKA, a serious complication of diabetes where the body lacks insulin. However, broader access to ketone measurement also brings questions around best practices for interpreting and acting on this new data.”
    • MedTech Dive interviews endrinologists about this development in the article. 

From the public health and medical / Rx research front

  • Tech Times lets us know where with stand with the summer Covid surge and what it means for the fall season.
  • Medscape relates,
    • “Adults on GLP-1s who lost weight during their first year on the medications are likely to maintain that loss through the second year of use, according to two new Cosmos studies.
    • “That finding was true for those with diabetes and without.
    • “We did observe that patients without diabetes had higher rates of maintaining that weight loss,” said Kersten Bartelt, RN, a researcher at Epic Research and a coauthor on both studies. And those on tirzepatide had lower rates of weight regain that those on semaglutide, the two medications studied.
    • “Bottom line? Continued use of GLP-1s means continued weight loss benefit or maintenance, Bartelt said.”
  • STAT News tells us,
    • “If you could design an oral treatment that limits appetite and mimics some effects of physical activity, you might call it exercise in a pill. Now a company is releasing early results for a compound to do just that.
    • “The pill, the company hopes, can maintain weight loss without the common gastrointestinal effects of GLP-1s. The component of exercise it is designed to re-create is preservation of lean muscle mass, a concern when people yo-yo on and off GLP-1 drugs, losing more muscle each time.
    • “Those researchers showed in a 2022 Nature paper that lac-phe can suppress appetite and lower obesity in animals. Lac-phe and ENV-308, Enveda’s chemically engineered version, both act on leptin, a hormone that has been the target of scientists and drug developers for decades. If confirmed in clinical trials, the company says, ENV-308 would be the first “leptin sensitizer in a pill.” 
    • “ENV308 is our attempt to put the chemistry of exercise into a daily tablet,” said Viswa Colluru, Enveda’s founder and CEO.”

From the U.S. healthcare business front,

  • Kaufmann Hall released its 2nd Quarter 2026 Physicians’ Flash Report last week.
    • The investment curve for providers has flattened. The investment/subsidy per both provider and physician has remained steady year-over-year, a positive sign for medical group performance.
    • Advanced practice providers (APPs) are helping control costs. The number of APPs continues to steadily increase, now making up 41.2% of the Total Provider FTEs represented in this sample. As medical groups continue to design strategic APP and physician staffing models, organizations may continue to see stronger returns in overall team effectiveness, productivity, and cost control.
    • Continued increases in productivity are offsetting expense growth but stretching providers. Physician and provider (APPs or otherwise) work relative value units (wRVUs) per FTE grew 3% and 2%, respectively, showing continued increases in productivity. While this may drive revenue to help offset expense growth, it can also increase burnout and impact quality of care.
    • Support staff levels continue to tighten, leaving providers to absorb more work. Support staff expense fell slightly, reflecting ongoing hiring and retention challenges. As staffing tightens, physicians and APPs may need to take on more non-clinical tasks, presenting challenges in working at the top of their license.
  • An AHIP news release adds,
    • “Each year brand drugmakers make tens of millions of dollars in payments to physicians— consulting fees, speaking honoraria, meals, travel and more. A new analysis of disclosures from 10 of the largest brand drugmakers, contained within the Centers for Medicare & Medicaid Services (CMS) Open Payments data, reveals these manufacturers spent nearly $200 million on payments to more than half a million physicians in 2024 alone.
    • “CMS data shows that physicians receiving payments from these 10 brand manufacturers then billed fee-for-service Medicare nearly $45 billion for drugs made by those same manufacturers in 2024. The return on investment for those manufacturers was a staggering $220 in sales for every dollar in physician payments. 
    • “This analysis builds on mounting evidence that physicians who receive manufacturer payments prescribe more drugs sold by those manufacturers.” 

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.”

Weekend Report

David Ermer–Agentic & Generative AI, CDC, Congress, COVID-19, Medical / Rx research, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • The House of Representatives is on a District work break until August 31, 2026, and the Senate is on State work break until September 14, 2026.
  • The Western Journal discusses the federal government’s efforts to stop paying benefits to beneficiaries who have passed away. FEHB and PSHB plans, as private entities, cannot use the federal government’s Do Not Pay system. It obviously would be helpful if OPM used the HIPAA 820 enrollment roster transaction which would allow FEHB and PSHB plans to reconcile premiums payments with individual enrollees. The HIPAA 820 tranaction has been in use since 2012, and FEHB and PSHB plans are reportedly the only plans serving large employers that do not benefit from the HIPAA 820.

From the public health and medical / Rx research front

  • IFL Science reports,
    • “Currently, there are more COVID cases in [California] than there were during the winter season. It is thought that this is being driven by the mutated “cicada” variant.
    • “Known more formally as BA.3.2, the variant was first identified in southern Africa in 2024. Since then, it has spread around the world, having now been detected in least 32 countries, including Australia, Germany, and the US.
    • “The variant has caught the attention of virologists and researchers because it has more than 70 spike mutations compared to the original wild-type virus.” * * *
    •  “Our summer peak was much higher in 2025 than it was in the winter,” Dr. Erica Pan, director of the California Department of Public Health and the state public health officer, said in a briefing.
    • “Summer is really the bigger peak. So if you do have patients or loved ones who have not gotten the ’25-’26 vaccines, it is still effective and highly recommended, given this surge we’re starting to see.”
    • “It seems that the shift from bigger winter to summer peaks started to occur around 2024. While so far this has been more noticeable in California, there is also evidence for this trend emerging right across the country.
    • “Why it is happening, and if the trend will continue, is still unknown.
    • “What is known, however, is that the COVID vaccines are safe and effective. A newly formulated shot is expected in the coming fall, but those at an increased risk of the disease can get a booster shot earlier if needed.”
  • The American Medical Association lets us know,
    • “One case of measles is concerning. Thousands are a warning.
    • “Our nation is experiencing the largest measles resurgence in decades—even though we have had a vaccine for more than 60 years. This year’s case count has already surpassed the total reported in all of 2025, making 2026 the worst year for measles our country has experienced in decades.
    • “For many physicians, measles is something they have read about rather than seen firsthand. That is a testament to the success of vaccination. It is also a reminder that vaccine-preventable diseases return when vaccination rates decline.
    • “For all clinicians, this resurgence is more than a public health statistic. It is a reminder that conversations about vaccination remain among the most important forms of preventive care we provide”
  • PBS News adds,
    • “The nationwide cyclospora outbreak is very likely a result of sewage contaminationin the food supply, according to scientific researchers and public health officials.” * * *
    • “As floods and droughts occur routinely across the U.S. and around the world, sewage may overflow into bodies of water or be used directly on crops. That increases the risk that diseases, including protozoa such as cyclospora, which are transmitted through ingestion of fecal matter, may spread through food and water supplies.
    • “And because cyclospora oocysts mature in outdoor heat, it is possible that increasing temperatures, such as heat domes, could speed up their maturation, exposing more people to the infectious form of the parasite.
    • “Modern technology and techniques are capable of monitoring water quality, detecting harmful pathogens and eliminating them. Expanding monitoring of wastewater for protozoan diseases and other dangers can help prevent outbreaks and slow the spread of disease from sewage-contaminated water in the future.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Memories can survive even after the brain temporarily loses more than half of its synaptic connections, according to the results of a study in mice that challenge the long-held view that long-term memories depend on stable individual synapses. The researchers, headed by a team at Okinawa Institute of Science and Technology (OIST), and including teams at the University of Tsukuba, Exploratory Research Center on Life and Living Systems (ExCELLS), and National Institutes of Physiological Sciences, used a mouse model of artificial hibernation to examine structural mechanisms underlying memory retention.
    • Their findings indicate that memory may be preserved not through individual synapses, but through resilient patterns of neural architecture, including specific clusters of connected synapses that remain protected during widespread hibernation-associated brain remodeling. These preserved structural motifs could act as a “core memory trace,” allowing the brain to rebuild functional networks after major disruptions.
    • “Research lead Kazumasa Tanaka, PhD, head of OIST’s Memory Research Unit, said, “Previously, synaptic strengthening was thought to be key to memory recall, and that stronger synapses with larger dendritic spines were fundamental to long-term memory retention. Here, we show that not every synapse matters, and demonstrate instead the vital importance of engram architecture. The study indicates that small clusters of engram-engram synapses are preserved to enable accurate recall even after hibernation.”
    • “Tanaka is senior and corresponding author of the team’s published paper in Science, titled “Artificial hibernation reveals synaptic engram architecture associated with memory retention.”
  • Health Exec points out,
    • “Higher doses of semaglutide were associated with significantly lower cardiovascular risk in patients with pre-existing cardiovascular disease, while the amount of weight loss achieved did not appear to predict subsequent cardiovascular protection, according to a large real-world analysis. This was according to a new article in the journal Nature.[1]
    • “The findings raise the possibility that semaglutide’s cardiovascular effects extend beyond weight reduction. This adds to growing clinical data showing how GLP-1 drugs are having a positive impact on patient health separate from weight loss outcomes.
    • “The degree of weight loss surprisingly did not correlate with cardiovascular protection as measured by all-cause mortality or multiple individual incident disease diagnoses,” explained lead author Karthik Murugadoss, a data scientist with nference and its Metabolism Agentic Intelligence Atlas (MAIA) initiative. “In a direct comparison of semaglutide to other anti-diabetic medications, semaglutide was associated with reduced rates of multiple cardiovascular endpoints after treatment initiation.”
    • “He said the findings suggest a cardioprotective role of semaglutide which may be related to attained dose, but is not explained simply by the amount of weight loss achieved while on therapy.”

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

  • The Wall Street Journal reports,
    • “Patients, families and healthcare professionals are turning to AI tools to help identify rare and hard-to-diagnose diseases.
    • “A study published in a JAMA journal found that two AI chatbots suggested the correct rare-disease diagnoses more often than doctors did.
    • “Doctors and researchers caution that AI tools still make mistakes and are limited by a lack of digitized data for rare conditions.”
  • Beckers Payer Issues relates,
    • “Point32Health, the parent organization of Harvard Pilgrim Health Care and Tufts Health Plan, logged an adjusted net income of $68 million for the second quarter of 2026. 
    • “According to an Aug. 14 update shared with Becker’s, this profit was up from an adjusted net loss of $25 million during the same period in 2025.
    • “For the second quarter of 2026, operating income was $38 million. The operating loss in the second quarter of 2025 was $57 million.
    • “Point32Health had 1.9 million members during the second quarter of 2026, slightly down from 2 million members during the same time in 2025. Revenue was $2.3 billion for the second quarter of 2026, down about 4% year over year.”
  • and
    • “Health insurers denied between 12% and 18% of standard prior authorization requests across Medicare Advantage, Medicaid managed care and ACA marketplace plans in 2025, with wide variation among the largest payers, according to a KFF analysis published Aug. 13.
    • “CMS previously finalized a rule requiring certain insurers to publicly report prior auth metrics, including denial rates, processing times and appeal overturn rates. The first reports, covering 2025, were due March 31. The data is aggregated across all items and services, with no breakdown by service type, so there’s limited insight into what services are being approved or denied. Payers are also not required to report reasons for denials.
    • “The rankings below only cover standard prior auth requests and they don’t include data for prescription drugs (though CMS has proposed a rule to require that information to be public as well). Denial rates for urgent requests, which are included in KFF’s analysis, were slightly lower across all markets.
    • “Prior auth denials are rarely appealed, but when they are, a considerable share are overturned, including 67% for Medicare Advantage plans, 47% in Medicaid managed care and 43% in the ACA marketplace.”

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.” 

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • The Senate remains in session this evening while it considers Senator Susan Collins substitute amendment #6732 to H.R.6500, the Senate’s legislative vehicle for a Continuing Resolution to fund the federal goverment from October 1, 2026, through December 11, 2026.
  • Roll Call adds,
    • “Sen. Bill Cassidy of Louisiana said Friday he intended to vote to confirm Todd Blanche to be attorney general, ending a weekslong back-and-forth with the White House to win over GOP holdouts.
    • “All eyes were on Cassidy’s Friday morning floor speech after his fellow Republican Sens. Susan Collins of Maine and Lisa Murkowski of Alaska announced they would vote against Blanche, citing myriad concerns such as the Epstein files, the so-called “anti-weaponization” fund and questions of his independence.
    • “With Sen. Mitch McConnell, R-Ky., still absent after a hospitalization, Senate Republicans could afford to lose only two votes in their ranks if all Democrats vote against Blanche. Had Cassidy not supported Blanche, Majority Leader John Thune, R-S.D., would lack the votes to confirm him before the August recess. Now he can move ahead and hold a final vote on the Senate floor.”
  • and
    • “A bipartisan bill aimed at combating hepatitis C is stalled in the Senate due to a high score from the Congressional Budget Office, the bill’s lead sponsor Bill Cassidy, R-La., said on Thursday.
    • “The bill, co-sponsored by Sen Chris Van Hollen, D-Md., proposes a national strategy to reduce hepatitis C infections by providing free medications and expanding testing for high-risk and vulnerable groups.
    • “Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee, is a former liver doctor who spent much of his career treating the disease and has said getting this bill across the finish line is a priority before he leaves Congress in January. But the measure has not advanced since its introduction in June 2025, despite bipartisan interest.
    • “There was a score on it that was a disappointing score, but there’s at least some conversations taking place by some with the CBO to get that re-scored,” Cassidy said Thursday afternoon.
    • “Cassidy’s office would not provide the exact figure for the bill’s estimated cost but did say it was higher than a related CBO estimate last Congress.”
  • Govexec points out, “The Senate on Friday confirmed in a 51-47 party-line vote multiple executive branch nominees, including several involved in government oversight and federal employee matters.” 
  • Per an August 5, 2026, AHIMA news release,
    • “AHIMA, a founding member of the Patient ID Now coalition, applauds the Senate introduction of the Patient Matching and Transparency in Certified Health IT (MATCH IT) Act of 2026 by Senators Mark Warner (D-VA) and Jim Banks (R-IN), a companion bill to H.R.2002 introduced in the US House of Representatives by Representatives Mike Kelly (R-PA) and Bill Foster (D-IL).
    • “The MATCH IT Act addresses the problem of patient misidentification within the healthcare ecosystem. The bill would create an industry standard definition for how patient match rates are measured and would improve standardization of patients’ demographic elements entered into certified health IT products to ensure patients are accurately matched with the correct medical record.”
  • FEHBlog observation: Congress should pass this bill.
  • Per an August 6, 2026, White House news release,
    • President Donald J. Trump and Vice President JD Vance are waging war on the fraudsters and scammers who have looted hardworking Americans for far too long.
    • Today, that war becomes fully transparent at fraud.gov — a new website where Americans can track every action, every takedown, and every dollar recovered as part of the unrelenting effort.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Aug. 7 released a procedural notice on its new pathway to expedite access to certain Food and Drug Administration-designated Class II and Class III devices for Medicare beneficiaries. The Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, is designed to reduce delays between FDA market authorization and Medicare national coverage determinations. CMS is accepting comments on the procedural notice for 60 days following publication in the Federal Register.”
  • Beckers Hospital Review reports,
    • “The U.S. economy lost 23,000 jobs in July, but healthcare kept adding positions, according to the Aug. 7 jobs report from the U.S. Bureau of Labor Statistics.
    • “Here are [three] things to know from the July jobs report:
      • 1. Healthcare employment continued its upward trend in July, adding 22,000 jobs, though that marked a slower pace than the average monthly gain of 36,000 over the prior 12 months.
      • 2. Hospitals were essentially flat in July, dipping by about 400 jobs after adding roughly 9,500 in June. 
      • 3. Ambulatory healthcare services drove most of the sector’s gains, adding 18,100 jobs, including 4,200 in offices of physicians and 4,600 in home health care services. Nursing and residential care facilities added 4,300 jobs. 
  • Per an August 7, 2026, U.S. Postal Service news release,
    • “The U.S. Postal Service today announced its financial results for the third quarter of fiscal year 2026 (Apr. 1, 2026 – Jun. 30, 2026). Controllable loss, which excludes certain expenses that are not controllable by management, was $1.0 billion for the quarter, compared to controllable loss of $1.6 billion for the same quarter last year.
    • “Net loss for the quarter under generally accepted accounting principles (GAAP) totaled $2.5 billion, compared to $3.1 billion for the same quarter last year. This $562 million decrease is attributed to an operating revenue increase of $1.1 billion along with a decrease in workers’ compensation of $416 million. These are partially offset by increases in retirement benefits of $324 million, retiree health benefits of $195 million, and compensation and benefits of $129 million.
    • “Our results this quarter reflect some progress relative to those areas of the business where we can exercise control, namely with revenue generation, cost control and service improvement,” said Postmaster General David Steiner. “Nevertheless, the Postal Service is today continuing to face a severe liquidity crisis, and our financial losses this quarter reflect systemic challenges inherent in our Congressionally established business model and regulatory framework. We are taking responsible steps to conserve cash to extend our operating window, but we require thoughtful legislative and other actions to establish a financially sustainable Postal Service capable of serving the American public far into the future.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “A Food and Drug Administration advisory committee meeting is scheduled for September to evaluate data for Grail’s Galleri multicancer early detection blood test.
    • “Grail launched Galleri as a laboratory developed test in 2021. Designed to detect signals from multiple cancers using a single blood sample, the MCED test hit a setback in February when a clinical trial missed its primary endpoint.
    • “CEO Josh Ofman told analysts on an earnings call this week that Grail continues to expect Galleri to receive FDA approval in the first part of 2027.”
  • Targeted Oncology tells us,
    • “The FDA has granted fast track designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of advanced platinum-resistant ovarian cancer in combination with pembrolizumab (Keytruda), according to a news release from BioInvent International AB.”
  • Fierce Pharma informs us,
    • “Fresenius Kabi voluntarily recalled one lot of morphine sulfate injection due to a labeling mix-up with prefilled syringes of the opioid dilaudid that could trigger an overdose resulting in severe respiratory distress or death.
    • “The recall, issued in a letter dated Aug. 4 and posted to the FDA website, is for a single lot of morphine sulfate marketed as Simplist 2 mg/1 ml that was mislabeled and could contain a prefilled syringe of dilaudid 0.5 mg/0.5 ml.”

No Surprises Act News,

  • The American Hospital Association News reports,
    • “Guidance on the implementation timeline for the No Surprises Act independent dispute resolution operations final rule was released Aug. 7 by the Departments of Labor, Health and Human Services, and the Treasury, along with the Office of Personnel Management. The final rule, issued May 28, was designed to streamline communication between group health plans and health insurance issuers, providers and certified IDR entities, while clarifying timelines and processes. The guidance includes details on applicability dates of certain provisions associated with the final rule, including the stand-alone claim adjustment reason codes and remittance advice remark codes guidance.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 7, 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. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “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 American Hospital Association reports,
    • “A study published Aug. 5 by Nature found that COVID-19 infection can reactivate dormant, chronic viruses such as Epstein-Barr and cytomegalovirus. The study found that reactivation is correlated with the severity of the COVID-19 infection. The study included data from more than 1,100 hospitalized patients with COVID-19 and found reactivation of various Herpesviridae and Anelloviridae viruses. Researchers said that reactivation occurred frequently in “immunocompetent” individuals during severe illness.”
  • The University of Minnesota CIDRAP relates,
    • “Working-age adults living with long COVID feel less satisfied with life, experience less happiness, and have less hope, according to a study published this week in BMC Public Health. The paper highlights the association between having long COVID and poorer wellbeing. 
    • “The findings underscore that the burden of long COVID extends beyond clinical health outcomes to encompass how individuals evaluate and experience their lives,” wrote the authors, from Syracuse University in New York.
    • “Long COVID symptoms were significantly associated with lower levels of subjective wellbeing in a dose-dependent manner.”  
    • “The World Health Organization defines long COVID “as the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation.”
  • and
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 94 new measles infections—most of them in Pennsylvania—bringing the US total for the year to 2,465, the agency said in its weekly update.
    • “The numbers likely provide additional data to move the United States toward losing its measles elimination status this year. The nation gained that distinction in 2000, but  has now logged consecutive years of more than 2,200 measles cases (2,289 for all of last year). This year’s total is the highest since 1991.”
  • The Washington Post tells us,
    • “Michigan health officials say new cases of cyclosporiasis are declining in the state hit hardest by an outbreak that has sickened more than 12,000 people and left two dead in the state since June. 
    • “The state’s health department said new case reports are slowing and diarrhea-related emergency department visits are trending downward. The drop in cases prompted officials to lift their broad recommendation to avoid bagged salad mixes. But Michigan continues to recommend avoiding recalled lettuce from Taylor Farms de Mexico sourced from central Mexico.
    • “Michigan officials said they believe most of their exposures took place in late June to early July and that most contaminated produce is probably no longer available for consumption.
    • “Cyclospora infections typically cause symptoms about seven days after exposure, although symptoms can take up to 14 days to appear. The health department said residents can now return to routine food-safety guidance for handling and consuming produce, including lettuce and salad greens.”
  • The AP informs us,
    • “In the past year, the U.S. has seen a jump in frequent marijuana users going to the hospital with a nausea and vomiting condition, according to a report released Thursday.
    • “The abruptness and sustained magnitude of the increase” is largely due to the condition getting its own diagnosis code last fall, which is providing a more accurate picture of what was an underrecognized problem, the authors of the U.S. Centers for Disease Control and Prevention report wrote.
    • “Hospital emergency room diagnoses of the condition, cannabis hyperemesis syndrome, rose 16% from last October to May of this year, federal researchers found.
    • “The syndrome — seen in people who frequently use marijuana, especially smokers — is characterized by recurring nausea, uncontrollable vomiting and excruciating abdominal pain.
    • “Past research has suggested that an estimated 2.75 million Americans suffer from it each year, and that hospital emergency room visits have been rising as daily recreational marijuana use has increased.”
  • MedPage Today points out,
    • “Maintaining three key health factors during midlife — normal blood pressure, no diabetes, and not smoking — was associated with nearly 13 additional dementia-free years, a study of 12,000 people in the U.S. showed.
    • “Individuals who met these criteria at age 55 lived an average 30.1 more years dementia-free, reported Josef Coresh, MD, PhD, of NYU Langone Health in New York City, and co-authors.
    • “Conversely, those who smoked, had hypertension, and had diabetes at age 55 had dementia-free survival of only 17.5 years, Coresh and colleagues wrote in Neurology Open Accessopens in a new tab or window.”
  • and
    • “Low-fat vegan diets can help aid in weight loss, but the mechanisms behind this have been unclear.
    • “Adults on a low-fat vegan diet reduced dietary energy density by 30% compared with controls in a secondary analysis of a randomized trial.
    • “Reductions in dietary energy density were significantly associated with greater weight loss after adjusting for overall energy intake.”
  • Medscape adds,
    • “Adding coronary artery calcium (CAC) scoring to risk estimates helped better identify adults at lower and higher risk for atherosclerotic cardiovascular disease (ASCVD) events. People with no detectable CAC had lower observed risk, while those with CAC had higher observed risk, especially when the decision about starting a statin was uncertain.”
  • Healio notes,
    • “Adults with type 2 diabetes and established CVD had lower risk for CV events with tirzepatide [a/k/a Zepbound] compared with sitagliptin [a/k/a Januvia].
    • “Tirzepatide decreased risk for infections leading to hospital admission.
  • Per Genetic Engineering and Biotechnology News,
    • “For people with severe food allergies, avoiding a trigger food like peanuts or tree nuts can mean constant vigilance. Approximately 8% of children and 10.8% of adults in the United States experience some type of food allergy. Even trace exposures can provoke reactions, and while oral immunotherapy can raise the threshold for some patients, the protection often depends on continued treatment and is associated with disease relapse in many patients. A new study suggests that another route to food tolerance may run through the gut microbiome.
    • “In a small Phase I open-label trial (NCT02960074), researchers at Boston Children’s Hospital tested whether oral encapsulated fecal microbiome transplantation (FMT) could safely increase peanut tolerance in adults with peanut allergy. The work, published in Science Translational Medicine, also used mouse models to probe how donor gut microbes might help restore oral tolerance. The study is titled, “Fecal microbiome transplant in food allergy in humans and mice identifies a role for bile acid metabolites in oral tolerance.”
  • The Wall Street Journal adds,
    • “Artificial-intelligence systems have been displaying some eye-opening new abilities in recent weeks: breaking out of their enclosures, hacking other companies, lying to people. 
    • “And now, for the first time, an AI model has created a new virus. A whole family of them, in fact. 
    • “In a study published in the journal Science, researchers at Stanford University and elsewhere said they successfully directed an AI model to create a collection of simple viruses that only infect bacteria and pose no threat to humans.
    • “In an interview, two of the authors said their research could help develop designer viruses that could be used to eliminate drug-resistant bacteria, which according to the World Health Organization kill millions of people every year.
    • “If we develop responsibly, I think it can lead to tremendous benefits in human health,” said Brian Hie, a computational biologist at Stanford and an author of the study.”

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

  • Fierce Healthcare reports, “Insurers see positive results in managing health costs in Q2.”
    • “The health insurance industry weathered a rough 2025, and the turnaround for some companies through the midpoint has surprised even Wall Street analysts.”
  • Beckers Payer Issues adds,
    • “Clover Health posted a $28 million profit for the second quarter of 2026, according to a recent earnings filing.
    • “During the same period last year, Clover logged a $10.6 million loss. The company had its first profitable quarter in 2024.
    • “Total revenue for the second quarter of 2026 was $743.2 million, up nearly 56% year over year. The company attributed the improved results to membership growth and a disciplined approach to administrative spend.
    • “On June 30, Clover had 157,309 members. The company’s benefit-expense ratio dipped to 87.6% this past quarter from 88.4% during the same time in 2025.”
  • and
    • “CVS Health’s pharmacy benefit manager, CVS Caremark, is bringing on Keith Reynolds as chief growth officer.
    • “Chief Sales Officer Jim Fowler will transition into retirement, according to an Aug. 7 LinkedIn post from Mr. Reynolds.” 
  • Beckers Hospital Review relates,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • [The article identifies] 52 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1
  • Health Exec adds,
    • “When a nursing home closes down, the local population and press often perceive the move as a simple exit from the market due to failing fiscal health. But in about half the cases, additional forces are in play—and “closures” may be, in truth, do-overs of one kind or another. 
    • “Researchers at the University of Massachusetts fill out the picture with facts in a study published July 31 by JAMA Health Forum.
    • “Joohyun Chung, PhD, RN, and colleagues suggest understanding the dynamics behind nursing-home closings is important because such events can disrupt continuity of care, place additional burdens on remaining facilities and disproportionately affect vulnerable populations.” 
  • Fierce Pharma tells us,
    • “Injected weight loss drugs remain favored over newer oral treatments by a significant margin, with Eli Lilly’s Zepbound leading the pack, according to a survey of healthcare specialists by Spherix Global Insights.
    • “In the poll, which includes input from 185 specialists in the United States, 80% were highly satisfied with Zepbound, compared with 59% for Novo Nordisk’s rival injectable, Wegovy. Though it remains early in the launches of Novo’s oral version of Wegovy and Lilly’s GLP-1 pill Foundayo, 48% and 47% of those surveyed were highly satisfied with the newer products, respectively.”
  • and 
    • “Prescriptions for Eli Lilly’s Foundayo continue to build, jumping 16% sequentially to 34,219 the previous week, according to IQVIA data cited by Citi. The oral GLP-1 med has been on a roll lately as it appears to celebrate four weeks of consecutive growth in total scripts. However, as Citi noted, there’s still a potential gap in IQVIA’s capture of telehealth data, and it’s not clear how much of the scripts growth was from IQVIA getting better at including those data, or, if the actual growth was much faster in telehealth channels.
    • “This week, Lilly’s reported Foundayo sales for the second quarter—$98 million in total, including $67 million in the U.S.—disappointed many. As CEO David Ricks noted on an earnings call, Lilly began broad direct-to-consumer marketing to raise consumer awareness after securing commercial access across the three major pharmacy benefit managers in June. Besides, The Medicare GLP-1 Bridge program went live on July 1, offering coverage for certain weight-loss medications, including Foundayo, for a $50 copayment per month. Ilya Yuffa, president of Lilly USA and global customer capabilities, said the company is “starting to see an inflection point on Foundayo now.”
    • “As for Novo Nordisk’s Wegovy pill, total scripts recorded by IQVIA have been largely flat with small upticks in the past two weeks, having reached roughly 172K in the previous week. The oral version of semaglutide now makes up 35% of total Wegovy scripts, which take up about 40.6% of the U.S. obesity market share, as Lilly’s Zepbound remains the leader.” 
  • Fierce Healthcare informs us,
    • “Despite the rapid implementation of artificial intelligence solutions across the healthcare industry, many organizations are still working on establishing necessary infrastructures and governance foundations, a new report from UPMC’s Center for Connected Medicine and KLAS Research found.
    • “Ninety-three percent of respondents report that their organizations deploy third-party AI solutions, though only 44% have a dedicated data platform or environment for tool testing. But 92% of respondents report testing third-party tools prior to deployment.
    • “What’s emerging from this research is a clear recognition that implementation is only the first step,” said Rob Bart, M.D., UPMC chief medical officer, in a statement. “Health systems are now focused on building the governance structures, testing capabilities and organizational strategies necessary to ensure AI delivers meaningful and measurable value.”
    • “The “Validation and Trust: The Governance of AI Solutions at Health Systems” report drew insights from 27 healthcare leaders, including those from health systems and ambulatory care organizations.” 
  • Healio adds,
    • “Many patients report high comfort with health systems using AI-written portal messages, noting it gets them information quickly and reduces clinician workload.
    • “Their comfort comes with caveats, though. Patients want both clinician oversight and transparency that AI is being used.”