Thursday report

Congress

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

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.” 

Weekend update

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

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.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From of a Washington, DC

  • The New York Times reports,
    • “The White House’s push to delay a ban on intoxicating hemp products that President Trump signed into law last year has snarled an otherwise straightforward effort to pass legislation that would lock in government funding through the fall before senators leave Washington on a summer recess.
    • “In an unusual display of defiance, a group of Republicans led by Senator Ted Budd of North Carolina was vowing to kill the hemp proposal that Senate leaders had tucked into the spending bill at the request of Mr. Trump.
    • “The measure would postpone the date the ban will go into effect, from November to Dec. 11.”
  • Beckers Hospital Review relates,
    • “Sens. Maggie Hassan, D-N.H., and Roger Marshall, R-Kan., introduced the Stop Superbugs Act on Aug. 4 alongside a Joint Economic Committee-Minority report estimating antimicrobial resistance costs the U.S. healthcare system at least $5.7 billion annually.”
  • Beckers Behavior Health adds,
    • Federal lawmakers have introduced or revived several bills this year [discussed in the article] aimed at expanding access to addiction and mental health treatment, from new Medicare coverage for residential opioid treatment to permanent funding for community behavioral health clinics.
  • The current president of the Infectious Diseases Society of America, Ronald Nahass, suggests in STAT News that “The U.S. needs a 9/11 Commission-style independent body to investigate Covid response.” The FEHBlog heartily agrees.
  • Beckers Payer Issues tells us,
    • “This fall, CMS will start sharing monthly utilization reports with Part D plans on how their enrollees are using the Medicare GLP-1 Bridge program.
    • “The agency said in an Aug. 5 memo that the reports will be organized at both the contract and plan level and will include claims-level data such as the date of service, drug dispensed, quantity, days supply, prescriber, fill number and beneficiary identifier. All Part D plans will be covered, except for PACE organizations, cost plans and private fee-for-service plans.
    • “CMS uses a central processor to handle prior authorization, claims adjudication and pharmacy reimbursement, meaning Part D sponsors don’t carry risk for GLP-1 drugs furnished through the demonstration. The utilization reports would give insurers a window into how their own members are using the program despite having no direct role in administering it.”
  • The Wall Street Journal adds,
    • “Amazon AMZN .com said patients with Medicare Part D prescription plans now have access to certain GLP-1 weight-loss medications through Amazon Pharmacy.
    • “Oral and injectable versions of Novo Nordisk’s NOVO.B  Wegovy and Eli Lilly’s LLY  Zepbound KwikPen and Foundayo pills will be available and cost $50 a month with free home delivery, Amazon said. It’s offering same-day delivery in more than 3,100 U.S. locations, and no Prime membership is required, the company added.
    • “The medications are available through the Medicare GLP-1 Bridge Program, a short-term federal initiative running through Dec. 31, 2027, that allows eligible Medicare Part D members who meet specific clinical criteria to access weight management prescriptions.” * * *
    • “Amazon Pharmacy manages the entire process, including verifying eligibility, handling prior authorizations, and initiating enrollment, once a clinician submits an electronic GLP-1 prescription, the company said. Customers need to link their Medicare information and Bridge insuranceplan to their account.
    • “Once a patient’s clinician sends the prescription, we take care of the rest and deliver their medication to their door,” said Tanvi Patel, vice president and general manager of Amazon Pharmacy.”

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

  • Govexec reports,
    • “President Trump is expected sometime this month to issue a plan to freeze federal employee pay in 2027, though if last year was any indication, it may not be that straightforward.
    • “When the White House published its fiscal 2027 budget proposal in April, the document, which normally lays out the administration’s pay plan for the following year, was silent on civilian compensation. The Office of Management and Budget later confirmed that Trump was in fact proposing “no pay increase” for 2027, while military service members would see between a 5% and 7% raise, depending upon their rank.
    • “Trump now has until the end of August to formalize his alternative pay plan for next year; otherwise, much larger automatic increases in locality pay would take effect, due to a formula in the 1990 Federal Pay Comparability Act that has been criticized by presidents of both parties since its enactment.”
  • Federal News Network explains how “OPM is preparing to take over federal employee appeals” as the FEHBlog has noted.
    • “OPM outlined significant changes in the new appeal adjudication process, including the loss of federal employees’ “categorical right” to a hearing.” 
  • Fed Agent informs us,
    • “Federal employees who file claims for back pay, unpaid overtime, unused leave, and other compensation issues will soon be required to submit them through the Office of Personnel Management’s (OPM) eFile system rather than by mail or email. 
    • “The changes could be especially relevant for law enforcement officers and other federal employees who file Fair Labor Standards Act (FLSA) overtime claims.
    • “In an updated rule for Procedures on Settling Claims, OPM said switching to an eFile system “will be used for all appeals and claims to allow for faster receipt facilitating OPM’s processing and review.”
    • “The new system will apply to a wide range of submissions, including claims filed by current and former federal employees, as well as claims submitted by beneficiaries of deceased federal employees and deceased veterans.”

From the FDA front,

  • The Wall Street Journal reports,
    • “Replimune Group said Thursday that the Food and Drug Administration has approved its therapy for advanced skin cancer, ending a regulatory saga that spanned three submissions and two rejections and was a flashpoint in the tenure of the agency’s last commissioner.
    • “Replimune’s drug, marketed as Tudriqev, is a genetically modified virus that doctors inject directly into tumors, where it is designed to kill cancer cells and trigger an immune response against tumors elsewhere in the body.
    • “The drug’s arduous journey through the FDA made it a poster child for the biotech industry’s criticism of the agency under former Commissioner Marty Makary. Replimune and other industry officials said the FDA, in its rejections, had reversed positions it had established in earlier meetings with the company.”
  • Targeted Oncology relates,
    • “The FDA granted accelerated approval to RP1 (vusolimogene oderparepvec; Tudriqev), an oncolytic virus therapy, in combination with nivolumab (Opdivo), for the treatment of advanced melanoma following progression on an anti–PD-1–containing regimen.
    • “The decision follows a July 30, 2026, meeting of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), which voted 10-3 in favor of the potential accelerated approval based on data from the phase 2 IGNYTE trial (NCT03767348). Despite the FDA raising concerns over the study design and clinical meaningfulness of the trial data, the committee supported the accelerated approval because of the unmet need in this setting, with the confirmatory IGNYTE-3 trial (NCT06264180) already underway to support regular approval.”

No Surprises Act News,

  • FHAS, a certifed independent dispute resolution entity, offers helpful guidance about implementing the NSA RARC codes in out-of-network electronic and paper claims.

From the judicial front,

  • Beckers Physician Leadership reports,
    • “A physician in Texas was sentenced to 12.5 years in prison for operating a medical clinic as an illegal pill mill. 
    • “Maryam Qayum, MD, owned, operated and was the sole prescriber at Recare Health Clinic in Houston. The clinic was operated as a cash-only pill mill, and Dr. Qayum issued prescriptions without a legitimate medical purpose, according to an Aug. 5 news release from the Justice Department. 
    • ‘Between 2022 and 2025, Dr. Qayum issued more than 3 million prescriptions for opioids including oxycodone and hydrocodone. Law enforcement shut down the clinic in 2025.”
  • Beckers Health IT relates,
    • “Health systems, insurers and AI companies are facing a wave of litigation in 2026 over how artificial intelligence is used to make or influence decisions about patient care, coverage and billing.”
    • The article discusses three such cases. 

From the public health and medical / Rx research front,

  • Health Exec identifies “Current and potential outbreaks to be aware of—and ready to talk about.”
  • Cardiology Business adds,
    • “The American College of Cardiology (ACC) has shared a new concise clinical guidance (CCG) detailing specific vaccine recommendations for adults and children with a history of cardiovascular disease (CVD).[1] The group reviewed its own evidence-based guidelines as well as updated resources developed by the American College of Physicians and U.S. Centers for Disease Control and Prevention. 
    • “Patients with heart disease face a higher risk of adverse outcomes, including hospitalization and death, following respiratory virus infection compared with the general population,” wrote first author Paul A. Heidenreich, MD, a cardiologist with Stanford University and chair of the CCG’s writing committee, and colleagues. “Additionally, the likelihood of infection after exposure may be elevated in this population.”
    • “Heidenreich et al. also emphasized that both randomized clinical trials and observational studies have consistently demonstrated the advantages of vaccination. Adverse side effects, the group added, are “exceedingly rare and are far outweighed by the demonstrated benefits.”  
  • MedPage Today notes,
    • “The U.S. Preventive Services Task Force recommends annual fecal immunochemical test screening starting at age 45 among average-risk adults to reduce the risk of death from colorectal cancer.
    • “In a retrospective population-based cohort study from Spain, fecal immunochemical test-based screening was linked to an ongoing decline in colorectal cancer mortality.
    • “Counterfactual analyses suggested a 41.7% relative reduction in mortality overall, a 46.2% relative reduction in those ages 50 to 69, and a 45.4% relative reduction in those ages 70 and older compared with projected trends without screening.”
  • The American Medical Association lets us know what doctors want their patients to know about hand, foot, and mouth disease.
  • The Washington Post reports,
    • “Hundreds of people in 27 states have been sickened in a salmonella outbreak linked to jalapeño peppers, including at Chipotle and Qdoba restaurants, the Centers for Disease Control and Prevention said.
    • “As of Tuesday, 345 cases had been reported with 36 people hospitalized, the agency said Wednesday. The cases, which date back to June 19, are expected to rise and expand to more states. 
    • “Twenty-seven “illness clusters” have been identified at Chipotle and Qdoba locations in seven states, the agency said, after health officials found that most of those who got sick reported eating in a Mexican-style restaurant. * * *
    • Neither restaurant is considered an ongoing risk, the CDC said. The distributor is recalling the affected peppers, and other businesses are being urged to check their stocks for recalled jalapeños and not sell or serve them, it said.
    • Salmonella bacteria, the most frequently reported cause of foodborne illness, can cause diarrhea, vomiting, fever and stomach pain.
  • Beckers Hospital Review relates,
    • “The CDC is tracking clinical cases of Candida auris in more than half of U.S. states this year, though the total number of infections from the deadly fungus is down from this time in 2025.
    • “The agency has recorded 3,302 clinical cases of Candida auris across 27 states through the week ending July 18, according to National Notifiable Diseases Surveillance System data. That’s down from 4,102 clinical cases reported over the same period in 2025.
    • “A separate CDC screening count, which tracks colonization detected before any illness develops, logged 3,130 cases across 23 states over the same period, essentially flat compared with 3,348 a year earlier.
    • ‘California leads all states in clinical cases with 826, followed by Texas with 391 and Ohio and Tennessee tied at 274 each. The screening count tells a different geographic story: Texas leads with 706 screening cases, followed by Michigan (503) and Illinois (366).”
  • Beckers Clinical Leadership adds,
    • “The Virginia Department of Health said Aug. 4 it has identified the state’s first locally acquired case of dengue.
    • “The patient lives in the Fairfax and Loudoun county area and had not traveled outside Virginia before falling ill.
    • “State officials traced the infection to an earlier traveler who had contracted dengue abroad. A local Aedes mosquito bit that infectious patient, then transmitted the virus to the second resident. The health department said it has found no evidence of continued local spread.
    • “The department called the overall risk of acquiring dengue in Virginia low.”
  • MedPage Today tells us,
    • “Anxiety and depression have been extensively studied in patients with inflammatory bowel disease (IBD), but research has rarely investigated the pre-diagnostic period.
    • “In a Swedish cohort study, the relative rate of any psychiatric disorder started to increase 2-3 years before IBD diagnosis, peaked soon after diagnosis, and rapidly decreased post diagnosis, but remained elevated at 10 years.
    • “This increased risk was mainly driven by major depressive disorders, anxiety disorders, and substance misuse.”
  • STAT News informs us,
    • “In the race for new ways to treat Alzheimer’s and other devastating neurologic diseases, the protein tau has become a tantalizing target for drug developers. A new study lends support to those efforts by describing a previously unknown role that tau plays in neurodegeneration — and suggesting a novel way researchers might block the protein’s activity.
    • “A team led by Stanford scientists found that tau can gum up the works of a cell’s mitochondria, its energy-producing powerhouse. The protein sends electrons flowing in the opposite direction of their usual microscopic relay race, a reversal that generates reactive oxygen species, cellular stress, and inflammation. Scientists found that blocking this phenomenon, known as reverse electron transport, reversed many of the harmful effects and improved learning and memory in flies and mice.
    • “Whether the same will hold true in people is for now unclear, though an analysis of human cells grown in the lab and patient brain tissue suggests blocking the retrograde flow of electrons could make neurons healthier. Two of the study’s authors have started a biotech startup to put this idea to the test. 
    • “The findings, published on Thursday in the journal Neuron, have implications for a range of so-called tauopathies, diseases marked by an abnormal buildup of tau, such as Alzheimer’s, Huntington’s, and frontotemporal dementia.”
  • Genetic Engineering and Biotechnology News points out,
    • Chronically infecting viruses—such as Epstein Barr, cytomegalovirus, and herpes virus—are ubiquitous in humans. Although their presence is often innocuous and asymptomatic, the viruses can reactivate during stress, and emerging evidence suggests that their reactivation may contribute to autoimmune disease and other chronic conditions. SARS-CoV-2 infection is known to reactivate some chronic viruses, yet the full extent of the effects is not well understood.
    • Now, a study including 15 biomedical research institutions across the United States, Boston Children’s Hospital researchers and their collaborators have discovered that COVID-19 reactivates certain dormant viruses in hospitalized patients. These findings expand understanding of chronically infecting viruses and could inform development of strategies to combat their reactivation.
    • “This work is published in a new study in Nature, entitled, “Virus reactivation in acute and long COVID-19.”
  • The New York Times notes,
    • “Novo Nordisk stunned the cardiology world last week when it announced that a large study it was running on an experimental drug for heart disease had failed. The drug, widely expected to be a blockbuster, was no better than a placebo.
    • “The drug, ziltivekimab, reduces inflammation, which is generally thought to be a cause of atherosclerosis. Stopping that inflammation was hoped to be a way to save lives.
    • “Now the drug’s failure is raising a troubling question. Is inflammation really a cause or is it just a marker of atherosclerosis, the way gray hair is a marker of aging?
    • “Cardiologists had mixed reactions to the news. Dr. Sanjay Kaul, a cardiologist at Cedars Sinai, quoted Thomas Huxley on X: “The great tragedy of science — the slaying of a beautiful hypothesis by an ugly fact.”

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

  • Health Exec points out,
    • “The latest lineup of America’s “best of the best” hospitals from US News & World Report is something of an embarrassment of riches for a few cities and health systems. 
    • “The list—which ranked hospitals numerically until 2023 but now presents 20 institutions alphabetically as an “honor roll”—names one health system three times.
    • “That would be Mayo Clinic, recognized for each of its operations in Rochester, Minn., Phoenix, Ariz., and Jacksonville, Fla. 
    • “Meanwhile New York City is home to three winning institutions—Mount Sinai, NewYork-Presbyterian and NYU Langone. 
    • “A few cities have two hospitals in the roll. These are Boston (Brigham and Women’s, Massachusetts General), Chicago (Northwestern, Rush) and Los Angeles (Cedars-Sinai, UCLA Ronald Reagan).
    • “The state with the most honorees is California, which has bragging rights to five—the two L.A. hospitals named above plus Stanford Health Care in Palo Alto, UC San-Diego Health in that city and UCSF Health in San Francisco.”
  • Beckers Hospital Review adds,
    • “The Emergency Nurses Association awarded a record-breaking 126 emergency departments with the 2026 Lantern Award.
    • “To receive a Lantern Award, EDs must submit a comprehensive application which measures how they excel in meeting challenges, including ED boarding, improving pediatric readiness and enhancing nurse professional development, according to a July 27 news release. ENA Lantern Award Committee reviews and scores applications based on evidence-based practices and innovation in emergency care. Learn more here. The Lantern Awards have been awarded annually since 2011.
    • “Last year, 96 hospitals received a Lantern Award.”
    • The article lists the 2026 awardees by State.
  • Beckers Hospital Review outlines the 23 hospital M&A transactions that have happened this year.
  • Beckers Payer Issues calls attention to “the thread running through payers’ and for-profit [health] systems’ Q2 earnings,” and tells us,
    • “Oscar Health’s membership as of June 30 was 2,963,002, up from 2,027,148 at the same time in 2025.
    • “The company reported net income of $361.8 million for the second quarter of 2026, up from a $228.4 million loss during the same period last year. Revenue was roughly $4.9 billion, up 70.4% year over year. Earnings from operations were $388.6 million versus a prior $230.5 million loss, driven by stronger underwriting performance, along with favorable prior period development.
    • “The insurer logged a medical loss ratio of 79.2% for the quarter, down from 91.1%. 
    • ‘The full-year 2026 outlook for earnings from operations is now $500 million to $700 million, a boost from $250 million to $450 million previously.”
  • BioPharma Dive reports,
    • “LifeMine Therapeutics, a biotechnology company led by serial entrepreneur Greg Verdine, said Thursday it raised $263 million in a pair of venture financings that will push a novel, protective treatment for organ transplants deeper into later clinical testing.
    • “To find that new drug, codenamed “LIFE-001,” LifeMine looked to a billion-year-old place: the fungal genome. It’s the same starting point that led to the first statin, penicillin, and a widely used immunosuppressant called cyclosporine. While these and many other medicines are derived from fungi, LifeMine has for years been working to make the discovery process more systematic and repeatable, amassing a database of genomic information in the hopes of uncovering promising drug prospects. 
  • MedTech Dive interviews “Medtronic’s George Murgatroyd [about] an advanced computing platform that works with the company’s Hugo robot will power AI algorithms that can assist surgeons as they operate.”

  • Beckers Physician Leadership notes,
    • “Aflac’s fourth annual Wellness Matters Survey found 76% of Gen Z and 63% of millennials now turn to artificial intelligence as their first line of primary healthcare, according to results released Aug. 4.
    • “The survey, conducted in March 2026 by Kantar Profiles among 2,000 employed U.S. adults ages 18 to 65, found AI use for healthcare drops sharply with age: 47% of all Americans surveyed use AI for health information, compared to 76% of Gen Z and 63% of millennials.
    • “The shift toward AI comes as younger workers skip in-person care. Sixty-five percent of Gen Z and 61% of millennials reported skipping routine checkups in the past year, compared to 47% of Gen X and 33% of baby boomers. Only 48% of Gen Z respondents have a primary care doctor, versus 87% of baby boomers.
    • “Emergency and urgent care use also rose among Gen Z, climbing to 62% in 2026 from 51% in 2025. Usage increased among Hispanic, Black, and Asian American respondents as well.
    • “Matthew Owenby, Aflac’s chief human resources officer and chief administrative officer, said younger Americans are substituting convenience for consistent care. “Young Americans are replacing in-person preventive care with the convenience and speed of digital health support,” Mr. Owenby said.”

Midweek report

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

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “A bipartisan group of senators Aug. 5 introduced the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act), a bill aimed at providing statutory clarity for the 340B Drug Pricing Program while establishing new transparency, reporting and program integrity requirements. The bill was introduced by Sens. Jerry Moran, R-Kan.; Tammy Baldwin, D-Wis.; Shelley Moore Capito, R-W.Va.; Tim Kaine, D-Va.; John Boozman, R-Ark.; and John Hickenlooper, D-Colo. 
    • “The AHA appreciates the leadership of the Senate 340B Bipartisan Working Group,” said Aimee Kuhlman, AHA group vice president of advocacy and grassroots. “We look forward to reviewing their legislation in detail, discussing it with our 340B hospitals, and working with them and other policymakers to ensure the 340B program remains strong for patients, communities, and providers across the country.”
  • and
    • “The Senate Aug. 5 voted 51-44 to confirm Erica Schwartz as the new director of the Centers for Disease Control and Prevention. Schwartz was previously deputy surgeon general during the first Trump administration.”
  • Per an Health and Human Service Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today began the decertification of Network for Hope, the federally designated organ procurement organization (OPO) serving Kentucky and parts of Indiana, Ohio, and West Virginia, after multiple federal reviews found persistent patient safety failures despite extensive oversight and despite Network for Hope having been provided repeated opportunities to correct them. Those failures put prospective organ donors and patients awaiting lifesaving transplants at risk.”
  • Roll Call relates,
    • “At King’s College Hospital in the south of London, anyone who has blood drawn in the emergency department is automatically tested for hepatitis B and C.
    • “Posters throughout the facility inform patients that the screening is routine, part of a new approach helping find and treat thousands of people who might otherwise never know they have the viruses, which can be fatal if left untreated.
    • “We pick up a lot of people who would never have actively accessed this kind of testing themselves — women in later life, people who’d never think they’re the sort of person who would have this condition,” said Dr. Oliver Mizzi, a consultant in emergency medicine at the hospital.
    • “Across England, 90 hospitals now have opt-out testing for hepatitis, leading to thousands getting treatment and putting the country on the path to meeting its goal of eliminating the hepatitis C virus as a public health threat by 2030.
    • “As Congress considers legislation to establish a national hepatitis C elimination program, experts say expanding opt-out testing in emergency departments is an indispensable way identify undiagnosed infections.”

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

  • FedSmith reports,
    • “The OPM retirement backlog kept falling in July, marking a fifth consecutive monthly decline. The backlog dropped by 9,067 cases, or 26.8%, last month to 24,784 total retirement claims, even as the average time to process a claim climbed to a record 109 days, the highest figure since OPM began publishing the data in 2018.
    • “The Office of Personnel Management (OPM) received 10,538 new retirement claims in July while processing 17,841 cases, a gap of more than 7,300 cases that continued pushing the backlog down. OPM has now cut the backlog for five straight months since it peaked at 65,237 in February.
    • “So far in 2026, the average number of retirement claims received per month (both digital and paper) is 15,336 and OPM has processed 17,594. For digital, the monthly averages have been 9,429 received and 8,726 processed.”
  • Per LinkedIn, James Muetzel has been promoted to the position of Principal Deputy Associate Director for Healthcare and Insurance at U.S. OPM.

From the Food and Drug Administration front,

  • Food and Wine reports,
    • “The FDA is investigating 10 active foodborne illness outbreaks, a higher-than-usual number that experts attribute to improved detection methods and a more interconnected food supply.
    • “Two Cyclospora outbreaks linked to iceberg lettuce account for the most reported illnesses, with cases in 41 states. Michigan reports the highest number of illnesses, hospitalizations, and deaths.
    • “The remaining FDA investigations involve Salmonella, Listeria monocytogenes, E. coli, and Clostridium botulinum. Some are linked to recalled products such as frozen blueberries, powdered infant formula, eggs, and soft cheeses, while others remain under investigation.”
  • STAT News relates,
    • “The Food and Drug Administration on Wednesday approved a novel type of treatment for narcolepsy made by Takeda, backing a drug class that scientists hope can transform the treatment of sleep disorders and potentially address a broad range of neurologic conditions. 
    • “The twice-a-day pill, which will be marketed as Orzeyful, is an orexin receptor agonist. It’s cleared to treat narcolepsy type 1, a taxing condition in which patients have a deficiency of the orexin neuron and experience bouts of sleepiness and muscle weakness during the day.
    • “The drug is likely to be very appealing to patients. Current therapies, stimulants and sodium oxybates, carry risk of misuse, and patients still feel sleepy while taking them. In two Phase 3 trials, Orzeyful helped patients stay awake during the day for much longer than what’s been seen with current treatments. Throughout the studies, participants also reported less daytime sleepiness, less frequent muscle weakness, and greater attentiveness.”
  • BioSpacc lets us know,
    • From an outright refusal to file to a backpedaled review earlier this year, Moderna has secured the FDA’s greenlight for its mRNA-based flu vaccine mFLUVISA.
    • The decision, revealed late on Wednesday, grants traditional approval for mFLUVISA to prevent seasonal influenza in patients 50 through 64 years of age, and accelerated approval for use in people 65 years and older. MFLUVISA is the first mRNA-based flu shot in the U.S., according to Moderna’s announcement.
    • The company expects to make mFLUVISA available “in the coming weeks,” in time for the 2026-2027 respiratory virus season in the U.S. Moderna didn’t disclose pricing for mFLUVISA.
  • Per a Reckitt news release,
    • “Reckitt announced today a milestone for the cold and flu category and the company: Mucinex® 12HR Cold & Fever Multi-Symptom is the first U.S. Food and Drug Administration (FDA)-approved over-the-counter (OTC) innovation in the cold and flu category in 14 years, and the first New Drug Application (NDA) under the Reckitt name to receive FDA approval.¹ Developed to align with the way consumers choose to manage cold and flu symptoms, this achievement reflects more than a decade of Reckitt’s scientific research, development, clinical evaluation and regulatory collaboration.”
  • MedTech adds,
    • “BD is recalling certain lots of intraosseous vascular access system needle sets due to a problem associated with four deaths, according to a Food and Drug Administration early alert posted Tuesday. 
    • “The needles are used to provide access to the bone marrow in emergency care situations when intravenous access is difficult. BD said in a statement last week that certain lots were manufactured with out of tolerance dimensions and may be more difficult to remove after placement. 
    • “BD reported four deaths where inability to remove the stylet occurred during resuscitation efforts for cardiac arrests. The company has received 75 complaints, including 45 serious injury reports.”

From the judicial front,

  • The New York Times reports,
    • “The Justice Department filed charges on Tuesday against Dr. Stephen Dubin, a doctor in Nevada, alleging that he orchestrated a $95 million Medicare fraud scheme that involved applying expensive and unnecessary wound coverings to elderly patients.
    • “Dr. Dubin was included in a 2025 New York Times investigation into skin substitutes, bandages manufactured out of dehydrated placentas that cost thousands of dollars per square inch but have not been found to help most wounds heal any better than regular bandages.
    • Medicare paid nearly $15 billion for skin substitutes in 2025, a spike that analysts have called one of the largest examples of waste in the federal health program’s history.
    • “After the Times investigation, the Trump administration sharply cut reimbursement rates for skin substitutes. Spending on the products has since plummeted to $100 million so far this year.”

From the public health and medical / Rx research front

  • Medscape reports,
    • “The ranks of long-term cancer survivors are growing, thanks to improved therapies, but along with that welcome trend comes a hard truth: Life-saving treatments can also have sometimes lasting adverse effects.
    • “Cardiac damage, a well-known risk of certain chemotherapies and other cancer treatments, may arise during treatment. But it can also surface years later, when it may not be recognized as a cancer therapy side effect.
    • “That’s the tsunami coming to medical systems around the world,” said Alexander Lyon, BM, BCh, PhD, a consulting cardiologist at Royal Brompton Hospital in London, England, and the co-chair of a task force that issued the first European guidelines in cardio-oncology in 2022.
    • Those guidelines, and similar ones from US groups, recommend various measures for preventing, detecting, and managing cardiac toxicity from cancer therapy. 
  • Beckers Clinical Leadership relates,
    • “About half of US hospital patients were on an antibiotic in 2023 — essentially flat from 2015 — even as nearly all hospitals now run stewardship programs, a CDC survey found.
    • “Among 151 hospitals that took part in both the 2015 and 2023 point-prevalence surveys, antibiotic use held steady: 49.2% of patients in 2015 and 49.1% in 2023. The findings were published July 31 in Open Forum Infectious Diseases.”
  • Healio adds,
    • “A Mayo Clinic study showed that more than 80% of patients who did not meet prescribing criteria for acute sinusitis were unnecessarily prescribed antibiotics, revealing a gap in adherence to treatment guidelines.
    • “The researchers found that clinicians often relied solely on a 10-day symptom duration to justify prescriptions, ignoring evidence that viral infections — which cannot be treated by antibiotics — can last that long.” * * *
    • “Guidelines from both the Infectious Diseases Society of America and American Academy of Otolaryngology “suggest a conservative approach” to treating sinusitis, the study noted. Those guidelines recommend antibiotics when symptoms have persisted for more than 10 days while also advising treatment for severe symptoms such as high fever and purulent discharge or facial pain lasting for 3 or more days.”
  • and
    • “Men prescribed testosterone without hypogonadism had 49% higher risk for CV events than men with hypogonadism.
    • “Asian men without hypogonadism had the most pronounced increased CV risk among racial-ethnic groups.”
  • Alzheimer’s’ News Today informs us,
    • “A panel of 19 blood proteins may help estimate when symptoms of amyotrophic lateral sclerosis (ALS) will emerge in people who carry disease-associated genetic variants, a new study suggests. When the model was tested using data from carriers whose symptom-onset dates were known, its estimates differed from the actual timing by an average of 1.6 years.
    • “If someone carrying an ALS-associated genetic variant had asked me in the past when they would become symptomatic, I would have struggled to provide a reasonable estimate,” Michael Benatar, MD, PhD, senior author of the study at the University of Miami, said in a press release. “These biomarkers give us a far better idea of the timing, allowing us to estimate the time to symptom onset with an average error of about 18 months. That’s something we can work with.”
    • “The study, “Longitudinal plasma proteomics predict phenoconversion to clinically manifest ALS,” was published in Nature Medicine. The work was funded by the National Institutes of Health (NIH), the Muscular Dystrophy Association, the ALS Association, and other organizations.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health CVS  said it will revamp its weight management program through a partnership with Eli Lilly LLY  as the company lifted its full-year outlook and reported a nearly threefold increase in its second-quarter profit.
    • “The company on Wednesday said patients will be able to use the CVS Health app to view transparent pricing options for Zepbound and Foundayo, two Lilly GLP-1 treatments, by early in the fourth quarter. Those treatments also may be available for same-day pickup at CVS pharmacies, the company said.
    • “CVS Health also will offer expanded pharmacy support for GLP-1 patients and $29 MinuteClinic online visits for eligible patients to connect with clinicians about GLP-1 treatments.
    • “Weight management is a deeply personal health journey, and too many people face barriers before they start treatment,” said Sid Tenneti, interim president of CVS’ pharmacy and consumer wellness segment. “Our collaboration with Lilly is one more way we’re expanding direct to consumer access to help eligible patients find options that work best for them.”
    • “The company also lifted its full-year outlook, projecting revenue of at least $414 billion and adjusted earnings between $7.90 and $8.10 a share.” * * *
    • “In the health care benefits segment, revenue rose 3.5% to $37.54 billion, driven by an increase in the government business. Health services revenue rose 11.5% to $51.8 billion, and pharmacy and consumer wellness revenue ticked up about 0.7% to $33.82 billion.”
  • and
    • “Eli Lilly reported higher net income and revenue in the recent quarter, driven by surging demand for its GLP-1 weight-loss drugs.
    • “Sales of the weight-loss treatment Mounjaro rose 91% to $9.94 billion, while Zepbound sales increased 46% to $4.93 billion.
    • “Eli Lilly raised its full-year revenue outlook, but lowered the high end of its adjusted earnings guidance.”
  • Fierce Healthcare adds,
    • “AstraZeneca and Bristol Myers Squibb do not have any ongoing discussions about a potential deal, Reuters reported Wednesday, citing a senior source close to the matter.
    • “There is ⁠no deal between AstraZeneca and BMS. There ​never was a deal to be done, and ​there are no discussions between the companies,” the person said, as quoted by Reuters.
    • “The development comes after the Financial Times reported Sunday that AZ was in talks to combine with BMS. A merger would create a new pharmaceutical giant valued at nearly $400 billion.”
  • Modern Healthcare relates,
    • “A decades-old spin on traditional employee health benefits is making a comeback.
    • “Cigna Group subsidiary Cigna Healthcare, UnitedHealth Group subsidiary UnitedHealthcare division and a bevy of insurers and emerging companies are offering “level-funded” products to employers desperate to reduce rising healthcare costs.
    • “A level-funded plan is a hybrid of the two most common forms of employer-sponsored health insurance: self-funded plans (also called self-insured), under which the employer assumes all financial risk for medical costs and pays a third-party administrator to manage the plan; and fully insured plans, under which an employer pays premiums to an insurance company that bears the risk. Level-funded plans feature a cap on what employers pay paired with stop-loss coverage for excess costs.
    • “Level-funded plans are intended for small and midsized businesses that lack the resources to fully cover their workers’ claims in self-funded plans but are subject to significant year-to-year fluctuations in premiums based on medical expenses in fully insured arrangements. Level-funded plans can offer a balanced approach that mitigates both kinds of risk.”
  • Fierce Healthcare tells us,
    • “Hinge Health inked a deal to acquire a digital gastrointestinal care management startup as it moves to broaden its business beyond musculoskeletal and migraine care.
    • “Hinge Health plans to pick up Cylinder Health for $105 million in cash. The acquisition accelerates Hinge Health’s entry into one of healthcare’s largest underserved categories, executives said, and the company plans to launch an integrated gastrointestinal (GI) care program in 2027. The deal is expected to close in the third quarter.
    • “With its expansion into GI care, the company is “following the same playbook” as it used for MSK and migraine care, Daniel Perez, co-founder and CEO of Hinge Health, told investors during the company’s second-quarter earnings call Tuesday. The company’s vision from the outset has been “use technology to automate the delivery of care within MSK and beyond,” Perez said, noting that the company’s tech platform was designed to scale across multiple conditions.”
  • Beckers Payer Issues informs us,
    • “In 2026, Aetna offers the best digital experience among major insurers on both desktop and mobile, according to new research from Corporate Insight shared with Becker’s.
    • “Corporate Insight’s “2026 Commercial Health Plan Experience Benchmark,” published Aug. 5, evaluated 24 commercial payers across more than 240 desktop and mobile functions. The report identifies overall health plan leaders on each platform, as well as top experiences across eight key categories, including claims, coverage and health information, design and navigation, digital care tools, health and wellness resources, prescriptions and pharmacy, profile and settings, and support.
    • “The analysis also consisted of 32 subcategories and 120+ attributes covering functionality, design, navigation and usability. Websites and mobile apps received scores on a scale of 1-100. The 2025 rankings are here.”

Tuesday report

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

From Washington, DC,

  • Punchbowl News reports,
    • “The Senate’s ability to clear its pile-up of legislation and nominations before a five-week summer recess may come down to two GOP decisions: whether to attempt to pass a budget resolution and whether to force a crypto vote that could fail.
    • “A short-term government funding bill cleared its first procedural hurdle Monday night, with 89 votes — a major boost for the bipartisan push to fast-track it. That followed 86 votes for a landmark Russia sanctions bill last week.
    • “Neither bill can pass before the scheduled August recess without consent from all 100 senators. That gives Democrats leverage, and they’re using it against two Republican priorities.”
  • Beckers Behavioral Health relates,
    • “The Centers for Medicare & Medicaid Services released a toolkit to help state Medicaid and Children’s Health Insurance Program agencies strengthen oversight of applied behavior analysis (ABA) services for children with autism, according to an Aug. 4 news release from the federal agency. 
    • :This toolkit comes as Medicaid spending on autism therapy has surged in several states in recent years. In Colorado, Medicaid spent more on autism therapy for children last year than on emergency room care for all patients, according to a recent investigation by The New York Times. The investigation also found some clinics prescribe 25 or even 40 hours of therapy each week for young children. Average daily appointments also have increased over time, according to Medicaid data analyzed by Trilliant Health.” * * *
    • “CMS said the resource is designed to help states ensure ABA services are medically necessary, individualized and evidence-based while identifying fraud, waste and abuse. The agency said it does not establish new federal requirements, reduce Early and Periodic Screening, Diagnostic, and Treatment obligations, endorse a single ABA treatment approach or limit access to medically necessary care.”
  • The ABA toolkit is available at: https://www.medicaid.gov/medicaid/downloads/autism-services-aba-toolkit.pdf 
  • Beckers Clinical Leadership notes,
    • “CMS will require hospitals to report performance on a patient malnutrition measure starting in 2028 under the Hospital Inpatient Quality Reporting Program.
    • The agency finalized the measure as part of its fiscal year 2027 Inpatient Prospective Payment System final rule released July 31.
  • Beckers Payer Issues points out,
    • “ACA insurers are pitching a median rate increase of 15% for 2027, the second year in a row of double-digit premium hikes, according to a July 8 Peterson-KFF Health System Tracker analysis that was updated Aug. 3.
    • “The tracker reviewed 276 insurers in marketplaces across the country with publicly filed rates. The tracker’s analysis considered an insurer’s premium increase as the enrollment-weighted average rate change across its offerings in a state. While rates will be finalized in late summer, these filings provide a glimpse of the year ahead.” * * *
    • “For 2026, the median nationwide proposed rate change was 18%. The median finalized rate change was 20%.”

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

  • Govexec reports,
    • “Most funds offered as part of the federal government’s 401(k)-style retirement savings program finished July in the red, continuing the downward trend that began the prior month.
    • “Only the Thrift Savings Plan’s G Fund, which is made up of government securities, grew last month, increasing by its statutorily mandated rate of 0.39%. So far this year, the G Fund has gained 2.57% in value.
    • “The common stocks of the C Fund were virtually flat in July, falling 0.07% and bringing its 2026 performance down to 10.13%. And the international (I) fund lost 1.01% last month; since January, the I Fund is up 15.35%.
    • “The small- and mid-size businesses of the S Fund finished July 4.12% in the red. So far this year, the S Fund has gained 13.52%. And the fixed income (F) Fund lost 1.29% last month, bringing its 2026 losses to 0.56%.
    • “Each of the TSP’s lifecycle (L) funds, which shift toward more conservative investments as participants approach retirement age, likewise lost ground in July.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the electronic Official Personnel Folder (eOPF) Document Request Service (DRS), a secure online portal that enables eligible former federal employees to request and receive copies of their official personnel records electronically — eliminating a manual process that previously often required paper forms, agency requests, or a request to the National Personnel Records Center.”
    • * * * “Users access the Document Request Service through Login.gov, complete a one-time identity verification, and submit a brief online request. Once processed, they receive a secure email containing a time-limited download link to a password-protected ZIP file with their complete eOPF Employment Folder.
    • “The DRS is available to separated federal employees whose records are maintained in eOPF, as well as current federal employees whose agencies do not provide government-furnished equipment to access their own personnel records. Current employees with access to the eOPF application should continue to retrieve their records directly through that system.
    • “The launch of the Document Request Service is part of OPM’s broader effort to modernize federal human resources systems, improve customer service, and reduce reliance on manual, paper-based processes across the federal government. Additional information, including a user guide, is available at Documents Request Service – eOPF Resource Center.”
  • FEHBlog Observation — OPM continually is improving IT services for which the agency deserves credit. The efforts make it more puzzling why OPM has not yet implemented the HIPAA 820 Standard Enrollment Roster Transaction in the FEHB, PSHB, and FEDVIP programs.
  • Noah Peters, an OPM Senior Adviser has added a post to the Secrets of OPM blog titled (OPM.gov link) “Restoring Merit With the Right Civil Service Exam.”

From the Food and Drug Administration front,

  • QualityAssuranceMag reports,
    • “A multistate outbreak of E. coli O145:H28 infections has been linked to organic frozen blueberries from Frutas y Hortalizas del Sur S.A., of San Carlos, Chile, sold under the GreenWise brand at Publix.
    • “The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), along with state and local partners, are investigating the outbreak, which has sickened 12 and hospitalized four in two states, Florida and Georgia.
    • “Publix recalled all lots of GreenWise Organic Frozen Whole Blueberries and Whole Mixed Berries due to potential E. coli contamination. Recalled product was shipped to Publix retail stores in eight states: Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee and Virginia.” 
  • MedTech Dive relates,
    • “Caristo Diagnostics has received de novo authorization for an AI tool that quantifies coronary inflammation from routine imaging scans, the company said last week.
    • “The Food and Drug Administration authorization covers a device, CaRi-Heart, that uses coronary computed tomography angiography to estimate a patient’s risk of cardiovascular mortality over 10 years.
    • “Research suggests the tool could help physicians stratify risk among patients who present with chest pain but are free from obstructive coronary artery disease.”
  • and
    • “DeepHealth last week received the Food and Drug Administration’s 510(k) clearance for an artificial intelligence tool that reads breast ultrasound images and generates reports.
    • “The feature can help clinicians localize suspicious soft tissue lesions; characterize details about the lesion such as its shape, orientation, and margin; and generate a report with key findings and impressions. Radiologists still have control of the final assessment. 
    • “DeepHealth’s parent company, RadNet, plans to offer the tool across its network of imaging centers by the end of the year.”
  • Targeted Oncology tells us,
    • “FDA authorized a new rituximab biosimilar based on comprehensive comparability data demonstrating high similarity to reference rituximab and no clinically meaningful clinical differences. 
    • “Market expansion of CD20 biosimilars may increase competitive pressure, shaping formulary positioning, contracting, and purchasing decisions that weigh price against continuity of supply. 
    • “Rituximab remains foundational across B-cell malignancies and autoimmune indications, reflecting its CD20-binding mechanism and B-cell depletion via multiple immune effector pathways. 
    • “Class safety considerations persist, including boxed warnings for fatal infusion reactions, severe mucocutaneous reactions, HBV reactivation, and PML, alongside risks of serious infections.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has announced that Ascend Laboratories is recalling specific lots of dabigatran etexilate, a blood thinner taken to reduce the risk of stroke or blood clots in patients with nonvalvular atrial fibrillation. This is a generic version of a popular direct oral anticoagulant (DOAC) most commonly sold by Boehringer Ingelheim under the brand name Pradaxa. 
    • “The recall was put in place due to a failed impurity/degradation test. After 12 months, the drug produced an out-of-specification (OOS) test result.“
    • “The FDA is still investigating this issue. Click here for additional details from the agency.”
  • The American Hospital Association News points out.
    • “The Food and Drug Administration Aug. 3 identified Class I recalls of two convenience kit products. Certain kits by Medline Industries have been recalled due to the containment of recalled Huons Bupivacaine Hydrochloride Dextrose Injections. The injections pose a risk of infection, inflammatory response and/or reduced anesthetic effectiveness. Certain convenience kits by Medical Action Industries have also been recalled due to the containment of Medline’s Namic Angiographic Star Off Handle Manifolds, which have been found to contain particulate within the fluid path of the manifolds.
    • “In addition, the FDA issued an early alert for certain Intraosseous Vascular Access System Needle Sets by Becton Dickinson due to some lots being manufactured with out-of-tolerance dimensions. BD said it has resulted in some lots being manufactured with out-of-tolerance dimensions, with some users reporting difficulty removing the obturator following placement of the needle sets.” 

From the public health and medical/Rx research front,

  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention is expanding the largest known cyclosporiasis outbreak to 15 states, adding six states where illnesses have been traced to shredded iceberg lettuce sourced from central Mexico, according to three individuals familiar with the investigation.
    • “Missouri, which is reporting 1,095 cases, is one of the states being added, according to a state health department spokesperson. The number of state cases jumped dramatically in the past week. Patients who were interviewed at length by state and local investigators said they consumed Taco Bell before getting sick, spokesperson Lisa Cox said.
    • “The other states are Arkansas, Iowa, Nebraska, New Hampshire and North Carolina, according to a fourth person familiar with the investigation.”
  • The New York Times considers,
    • “Is It OK to Eat the Same Things Every Day?
    • “Some people do it to lose weight, others to avoid the hassle of planning meals. We asked experts how “food monotony” affects your health.”
  • Beckers Hospital Review relates,
    • “In 2025, New Mexico confirmed 100 measles cases across nine of its 33 counties, and each case cost an average $53,522, according to research published Aug. 4 in Annals of Internal Medicine. 
    • “Researchers with the CDC and New Mexico Department of Health analyzed the societal economic burden of these 100 cases through public health response costs, direct medical costs and productivity losses. The public health response costs totaled about $3.2 million, including $2.1 million for vaccination-related activities. About 130 public health responders worked on contact tracing across 205 contacts, which each cost $1,817, according to the study. 
    • “The $53,522 per measles case, equal to $5.35 million in total, ranged from February through September 2025.”
  • MedPage Today tells us,
    • “A peptide vaccine targeting KRAS mutations in patients at high risk for pancreatic cancer induced durable T-cell responses.
    • “In 16 patients with evaluable pancreatic cysts, three had complete resolution of the cysts, three had partial regression, and the rest had stable cyst status.
    • “No patient developed severe vaccine-related adverse events.”
  • and
    • “In a randomized trial, a novel system for autonomous control of supplemental oxygen for inpatients who needed it improved the proportion of time spent with adequate oxygen levels.
    • “The study showed safety of the approach and lower oxygen use overall compared with usual care.
    • “The trial could not assess clinical outcome effects like reduced respiratory decompensation, shorter hospital stays, or improved survival.”
  • Health Day points out,
    • “Women who enter menopause at an earlier age have an increased risk of high blood pressure, a new study says.
    • “Researchers found that nearly 23% of women with premature menopause and 19% of women with early menopause had high blood pressure, compared to under 17% of women with normal menopause, researchers found.
    • “Overall, premature menopause brought a 12% higher risk of high blood pressure compared to women who reached menopause after age 45, researchers reported recently in the journal Menopause.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Recurrent urinary tract infections (rUTIs) are among the most common bacterial infections worldwide. The difficult-to-treat condition, which affects primarily women, is defined as two urinary tract infections (UTIs) within six months or three UTIs within the past year. They are a leading cause of outpatient antibiotic use, accounting for more than 15% of all prescriptions.
    • “While antibiotics remain the standard treatment, frequent recurrences and rising antibiotic resistance highlight the need for alternative therapeutic approaches. Now, researchers have, for the first time, administered a combined phage therapy (PT) with fecal microbiota transplantation (FMT), to decolonize urinary and intestinal reservoirs of rUTI patients.
    • “The novel treatment approach, combining PT and elective FMT, was administered to three female patients, between May and July 2023, with rUTI that did not respond to antibiotics and commonly used non-antibiotic strategies. All had microbiologically confirmed E. coli in multiple infections.
    • “All three women received PT orally and intravesically (locally applied to the bladder via catheter) for eight days outside of acute episodes. Two of these three patients were elected to receive subsequent FMT. Since the bacteria causing the recurring infections often reside in the gut as well as the urinary tract, the FMT treatment targeted the intestinal reservoirs of E. coli that survive antibiotic treatment of acute infections and can become increasingly resistant.
    • “While phage therapy acts to remove the pathogen, FMT aims to restore a healthy microbiome, combining both immediate and long-term effects,” Lena Biehl, MD, PhD, group leader at Fraunhofer ITMP, deputy lead of Cologne Microbiota Bank, University Hospital Cologne.
    • “This work is published in Nature Microbiology in the paper, “Combined Phage therapy and fecal microbiota transplantation to treat recurrent urinary tract infection: a case series.”
  • Per Fierce Pharma,
    • “In a milestone for IgA nephropathy, Otsuka’s Voyxact has shown for the first time in a phase 3 trial that a drug can stabilize patients’ kidney function decline to the normal rate seen in healthy adults. 
    • “Results from the phase 3 Visionary trial showed that Voyxact (sibeprenlimab) achieved an annualized estimated glomerular filtration rate (eGFR) slope of a 0.3 mL/min/1.73m² gain over two years, suggesting an improvement in kidney function. The rate matches the normal age-related decline of less than 1 mL/min/1.73m² per year, as laid out in the KDIGO 2025 Clinical Practice Guideline for IgAN.
    • “To be presented at the GlomCon Hawaii 2026 conference, the latest Voyxact result is better than an annualized eGFR slope of negative 4.2 mL/min/1.73m² for placebo. It’s also better than Voyxact’s own performance over 12 months, when it recorded an annualized loss of 3 mL/min/1.73m² at an interim analysis of the Visionary trial.”
  • and
    • After a yearslong struggle, Jazz Pharmaceuticals has called time on Zepzelca as a second-line treatment for small cell lung cancer.
    • In alignment with the FDA, Jazz plans to ask the agency to remove the second-line SCLC indication from Zepzelca’s label, the company said Monday alongside its second-quarter earnings report.
    • The decision comes after the confirmatory phase 3 Lagoon trial recently failed on its primary endpoint of overall survival. In the study, Zepzelca (lurbinectedin) monotherapy performed even worse than other chemotherapy regimens, while a combination of Zepzelca and irinotecan showed a numerical advantage that didn’t meet statistical significance.

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

  • Beckers Payer Issues tells us,
    • “Louisiana workers pay the largest share of their income toward their portion of health insurance premiums, while workers in Hawaii pay the smallest, according to an AHIP analysis of Commonwealth Fund data published in July.”
    • The article lists all of the States’ percentages. 
  • and
    • “UnitedHealthcare is rolling out new reimbursement limits on five categories of lab tests across its commercial, ACA, Medicare Advantage and Medicaid plans.
    • “The five policies cover allergen testing, liver fibrosis testing, in vitro chemotherapy sensitivity assays, testosterone blood tests and vitamin B12 testing. 
    • “The policies generally take effect Sept. 1 for commercial, exchange and MA plans, though several states have an effective date of Oct. 1 in the commercial and exchange markets. The Medicaid rollout is staggered by state, with effective dates ranging from August through November.
    • “Broadly, the policies set frequency caps or exclude specific test types from reimbursement.”
  • Fierce Healthcare informs us
    • “AI health tech company Daffodil Health is rolling out a new platform aimed at supporting payers in managing the No Surprises Act dispute process.
    • “The number of cases reaching the NSA’s independent dispute resolution process continues to grow. For example, when the process was established by regulators, they projected about 17,000 cases would make it to IDR each year—however, 1.2 million were filed in just the first half of 2025.
    • “Daffodil’s tool is built to support insurers and third-party administrators in handling that volume of disputes, starting with intake and through negotiation, arbitration and reporting, the company said in an announcement.”
  • Beckers ACS Review lets us know,
    • “Austin, Texas-based Ouma Health has acquired a multisite maternal-fetal medicine practice led by Tamara Takoudes, MD, expanding the telemedicine company’s footprint across Connecticut, Massachusetts, Maine and New Hampshire, according to an Aug. 4 news release.
    • “The acquisition adds established in-person clinical locations to Ouma’s national teleMFM network and strengthens the company’s relationships with hospitals, imaging centers, birth centers and community obstetric practices across New England. 
    • “Ouma, which describes itself as the nation’s largest independent maternity telemedicine company, said the deal is part of a broader effort to build clinical infrastructure for high-risk pregnancy care as MFM workforce shortages and hospital labor and delivery unit closures continue to limit access in many communities. Financial terms were not disclosed.”
  • Beckers Behavioral Health adds,
    • “San Francisco-based Amae Health, a provider of mental healthcare, is collaborating with Google Health Enterprise to bring wearable-derived data into its precision psychiatry care model.
    • “The collaboration will allow Amae Health’s care teams to incorporate data from wearable devices — including sleep patterns, physical activity, heart rate variability and changes in daily routines — alongside existing clinical information, according to an Aug. 4 news release. The company said the additional data is intended to help clinicians detect changes in patients’ conditions earlier and better identify potential relapses among people with schizophrenia, bipolar disorder and major depressive disorder.”
  • Per a Lown Institute news release,
    • “U.S. hospitals can excel at both clinical care and making critical investments in the people and communities they serve. That is the key takeaway of the 2026 Lown Hospitals Index ‘Honor Roll’, which recognizes 123 institutions that achieved top ratings on health equity, value of care, and patient outcomes.
    • “With financial pressures forcing painful choices on many hospitals, those on the Lown Honor Roll have found ways to put their patients and communities first,” said Vikas Saini, MD, president of the Lown Institute. “These hospitals are staying true to their mission when it matters most, and in healthcare, that’s everything.”
  • Per Beckers Hospital Review,
    • U.S. News & World Report released its 2026-27 Best Hospitals rankings and ratings Aug. 4, which included a list of 505 Best Regional Hospitals across 49 states and the District of Columbia.
    • The latest edition of Best Hospitals, now in its 37th year, evaluated hospitals on measures such as risk-adjusted mortality rates, preventable complications and patient experience. This year’s rankings placed significantly greater weight on risk-adjusted patient outcome measures in determining results. For the first time, Maternity Care recognition was also incorporated into Best Regional Hospitals point calculations. More information about the methodology is available here and here.
  • Healthcare Dive adds,
    • “New Jersey health system Hackensack Meridian Health has become the first organization to earn the Joint Commission’s seal of approval for the responsible use of artificial intelligence in healthcare.
    • “The Joint Commission, an independent accreditation organization, launched the certification in June with the goal of endorsing U.S. healthcare organizations able to demonstrate they have the proper governance, resources, policies and training programs for the safe and effective use of AI.
    • “HMH has been refining its AI systems for years, according to Dr. Lauren Koniaris, the organization’s chief medical informatics officer. “As we expand our clinical AI initiatives, we operate under the utmost governance to ensure patient quality and safety are always the priority,” she said”
  • Per the Wall Street Journal,
    • “Pfizer reported second-quarter revenue of $15.03 billion, up 3% and beating analyst expectations as non-Covid drug sales grew.
    • “Pfizer recorded a second-quarter loss of $248 million, driven by a $3.8 billion write-down on an experimental lung-cancer drug.
    • “Pfizer raised the low end of its full-year sales guidance to a range of $60.5 billion to $62.5 billion.”
  • and
    • “Amgen AMGN  lifted its outlook for the year after strong drug sales bolstered the company’s bottom line in the second quarter, but added that it would end development of an early-stage obesity treatment.
    • “The biotechnology company on Tuesday said it was halting the development of AMG 513, a potential obesity treatment currently in a phase 1 study. That study will be carried to completion to follow enrolled participants, Amgen said. The company didn’t provide a reason for the discontinuation.
    • “With development of AMG 513 ending, Amgen’s only candidate in the space is MariTide, which is currently in phase 3 studies for a range of indications such as obesity, Type 2 diabetes and chronic weight management.
    • “Amgen also lifted its guidance, saying it now expects full-year revenue between $38.2 billion and $39.4 billion, up from a previous view of $37.1 billion to $38.5 billion. Adjusted per-share earnings are expected between $22.30 and $23.50, up from a range of $21.70 to $23.10.”
  • and
    • “Gilead Sciences reported second-quarter revenue rose to $7.8 billion, but swung to a $10.5 billion loss due to acquired research expenses.
    • “Gilead Sciences’ revenue growth was driven by a 12% rise in HIV product sales to $5.69 billion, while sales of Covid-19 drug Veklury fell 81%.
    • “Gilead Sciences narrowed its full-year product-sales guidance to a range of $30.1 billion to $30.4 billion.”
  • and
    • “Novo Nordisk said annual sales and operating profit should fall less than previously expected following a boost in the second quarter.
    • “Novo Nordisk expects adjusted sales and operating profit to decline up to 6% at constant exchange rates this year, compared with its prior forecast of a 4% to 12% decline.
    • “Adjusted sales for Novo Nordisk grew 7% to 78.49 billion Danish kroner in the second quarter, while adjusted operating profit rose 11%.”
  • STAT News adds,
    • “BioNTech on Monday named Guido Oelkers, formerly the leader of the Swedish biopharma company Sobi, as its new CEO, as the Covid-19 vaccine developer continues its shift to oncology.
    • “Oelkers will replace Ugur Sahin as CEO. In March, BioNTech announced that Sahin and his cofounder and wife Özlem Türeci, the company’s chief medical officer, would depart the company to lead a new biotech focused on developing mRNA medicines.
    • “Oelkers, who has worked in biopharma for more than 30 years, will start by Feb. 1, 2027, the company said. He said that he would continue BioNTech’s work to be a global company with multiple approved medicines by 2030.”
  • BioPharma Dive helps us track the patent expiration dates of name brand prescription drugs.

Monday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NCQA, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • STAT News reports,
    • “Senate leadership on Sunday released the text of a bipartisan government funding stopgap measure that would block the White House’s proposal to give political appointees control over federal research grants. 
    • “The continuing resolution would fund the government until Dec. 11. It would only block the Trump administration’s new grants proposal until that time, but it will be more difficult for Republicans to allow the White House’s plan to take effect now that they’ve agreed to blocking it, even if temporarily.” 
  • Roll Call adds,
    • “Just as Senate GOP leaders plan to begin moving several big-ticket items ahead of a planned August recess, President Donald Trump will head out west for a Los Angeles-area fundraiser and an economic speech in Las Vegas.
    • “Trump is set to return to Washington, D.C., Wednesday night — when the chamber could be a few votes away from a monthlong recess in a midterm election year. And the president’s recent statements, threats and willingness to shift on policy shows he’s capable of slowing things down.” * * *
    • “[Senate Majority Leader John] Thune has teed up an ambitious week as he tries to move several big-ticket measures while also freeing vulnerable GOP senators to get back home to campaign until mid-September. He wants to pass a continuing resolution to fund the government until Dec. 11, including a number of White House-requested priorities the House did not have when it passed its own continuing resolution before leaving for the summer last month.
    • “Also on Thune’s list: a cryptocurrency bill, over 70 executive branch nominations and a Russia sanctions bill largely crafted by the late Sen. Lindsey Graham, a South Carolina Republican and close Trump ally.”
  • and
    • “The Senate is back on track to consider acting Attorney General Todd Blanche’s nomination to lead the Justice Department permanently after two key GOP holdouts said they were “pleased” with a deal they struck. 
    • “The DOJ said in a statement posted Sunday night that it has “rescinded” a $1.8 billion “anti-weaponization” fund meant to compensate people targeted by the federal government. The fund was part of a settlement brokered by Blanche that resolved President Donald Trump’s $10 billion suit against the Internal Revenue Service tied to the release of his tax returns during his first term in office.
    • “It was enough to satisfy Sens. John Cornyn, R-Texas, and Thom Tillis, R-N.C., who expressed “gratitude” in a Monday statement and wrote, “We look forward to voting to advance his nomination out of the Senate Judiciary Committee soon.”
    • “The Judiciary panel is now scheduled to vote on Blanche’s nomination Tuesday morning, after canceling a meeting last week.”
  • Govexec relates,
    • “Federal employees and contractors whose sensitive personal data was stolen in the massive Office of Personnel Management breaches disclosed a decade ago would receive identity protection for the rest of their lives under new bicameral legislation.
    • “Senate Intelligence Committee Vice Chair Mark Warner, D-Va., and Del. Eleanor Holmes Norton, D-D.C., plan to introduce the RECOVER PII Act on Monday, aiming to prevent the federal government’s identity-protection program for victims from expiring Sept. 30, according to bill text first seen by Nextgov/FCW.” * * *
    • “Congress responded to the breach in a 2017 appropriations law by requiring OPM to provide victims with at least 10 years of complimentary identity protection and no less than $5 million in identity-theft insurance. The new bill would replace that limit with coverage lasting for the remainder of each affected person’s life while retaining the insurance requirement.
    • “We have a responsibility to stand by the federal workers who were put at risk through no fault of their own,” Warner said. “This legislation will ensure those affected continue to receive the identity protection they need, while helping better safeguard personal information from future exploitation.”
    • “The bill would also allow agencies to reimburse federal employees and contractors for privacy tools and services, such as those that remove or limit their personal information online. Agencies would decide whether to offer the reimbursements, which would not be limited to OPM breach victims and would come from their salary-and-expense budgets.”
  • Per Health and Human Services news releases,
    • U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today traveled to southwest Virginia as part of his “Take Back Your Health” tour to highlight Trump Administration’s efforts to expand addiction recovery, strengthen American agricultural and food supply chains, and recognize President Trump’s historic $50 billion Rural Health Transformation Fund.
    • “On Monday, Secretary Kennedy joined Congressman John McGuire for visits to Tranquility Grove Rehabilitation Center and the Virginia Tech Controlled Environment Agriculture Innovation Center. Under President Trump’s leadership, combating addiction and mental illness remains a national priority. The Administration is also advancing innovative agricultural technologies that strengthen domestic food production, improve supply chain resilience, and help deliver healthier food to the American people.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today marked National Health Center Week by announcing that Health Resources and Services Administration (HRSA)-funded health centers served more than 32.7 million patients in 2025 — an increase of more than 350,000 patients from 2024 and the highest number of patients served in the Health Center Program’s 61-year history.”
  • Per a Centers for Medicare and Medicaid Service news release,
    • “The Centers for Medicare & Medicaid Services (CMS) recently hosted the one-year celebration of the Health Technology Ecosystem, bringing together leaders from the government, healthcare, and technology sectors to feature the significant progress made over the past year in advancing interoperability, improving health data sharing, and expanding patient access to digital health tools.
    • “The event featured remarks from U.S. Department of Health and Human Services (HHS) leadership, with speakers reflecting on Health Technology Ecosystem accomplishments during its first year, highlighted industry collaboration, and outlined priorities for the initiative’s next phase.” * * *
    • “The event concluded with a discussion of the next phase of the Health Technology Ecosystem and opportunities to expand industry participation. Leaders also introduced new areas for future collaboration, including real-time benefits, price transparency, advanced appointment scheduling, clinical trial matching, bulk HL7® Fast Healthcare Interoperability Resources (FHIR®) capabilities, and provider add-on services. CMS encouraged additional organizations to join the initiative as the Health Technology Ecosystem continues to evolve through collaboration across government and the private sector.”
    • “A recording of opening session highlights is available at: https://youtu.be/ATVSdE4cnVQ?si=03QLFmQ2tuRx7w-O
    • “The recording of the full event is available at: https://www.youtube.com/playlist?list=PLaV7m2-zFKpgncdcV8Wnzv42DQo2ZqkUD“
  • Per an NCQA blog post,
    • “The Healthcare Effectiveness Data and Information Set (HEDIS®) is continuously evolving to reflect clinical best practices and to support the needs of organizations that deliver and coordinate care.
    • “For HEDIS Measurement Year (MY) 2027, NCQA introduced several updates:
      • “Added 6 new measures.
      • “Updated 3 existing measures.
      • “Transitioned 1 measure to Electronic Clinical Data Systems (ECDS) reporting.
      • “Restructured ECDS-reported measures reorganized by clinical domain.
      • “Made minor adjustments made across multiple measures.”
    • “NCQA seeks feedback about the proposed retirement of select HEDIS measures for Measurement Year (MY) 2027. The ad hoc public comment period is open from August 3 to August 17. Read on to learn more about the measures proposed for retirement and visit our public comment webpage to submit your comments.
    • “The newest additions to HEDIS address follow-up after a positive colorectal cancer screening, prenatal syphilis screenings, person-centered outcome goals and the use of continuous glucose monitoring.”

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

  • Federal News Network reports,
    • “The Trump administration is giving agencies the green light to implement a new performance management system for federal employees — while also saying significant portions of those changes are “non-negotiable” with federal unions.
    • “In recent guidance issued to agencies, OPM detailed which aspects of the government’s new performance review system override collective bargaining obligations — and what is still subject to negotiation.
    • “Generally, the guidance narrows federal unions’ ability to bargain over performance appraisals. Any collective bargaining provisions that allow for grievances over performance ratings, or that would prevent agencies from using a forced distribution system, are now non-negotiable with unions, according to OPM’s memo.
    • “But some aspects of performance management are still negotiable, according to OPM, as long as they remain consistent with both the final rule and any applicable laws. Those include employees’ informal requests for a reconsideration of their rating; rules on awards and recognition programs; and feedback procedures between supervisors and employees.”
  • The AI Journal relates,
    • “ACI International Inc (NYSE: CACI) announced today that it will serve as one of Oracle’s technology partners for the U.S. Office of Personnel Management’s (OPM) Federal Human Resources Information Technology (HRIT) Modernization contract. Working alongside Oracle, Baker Tilly, and Deloitte on this 10-year contract worth nearly $400 million, CACI will modernize and consolidate disparate federal human resource systems into a single, secure, cloud-based platform for federal civilian employees, including HR professionals and leaders. The consolidation of federal HR systems into a single shared platform is expected to reduce taxpayer costs by more than 90 percent while improving efficiency, security, and service delivery across the government.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Novartis’ blockbuster radioligand therapy Pluvicto has cleared a key milestone on its quest to hit $5 billion in peak sales, securing a U.S. nod in an earlier form of prostate cancer that nearly doubles the number of patients that could benefit from the drug. 
    • “Late Friday, the FDA signed off on Pluvicto in tandem with an androgen receptor pathway inhibitor (ARPI) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC).”
  • Alzheimers’ News Today relates,
    • “The U.S. Food and Drug Administration (FDA) has granted fast track designation to remlifanserin, an experimental treatment that Acadia Pharmaceuticals is developing for hallucinations and delusions associated with Alzheimer’s disease psychosis.
    • “The FDA grants this designation to investigational medicines intended to treat serious conditions and fill an unmet medical need. Fast track status provides benefits such as more frequent communication with the FDA, with the goal of speeding a therapy’s development and review.
    • “FDA Fast Track designation for remlifanserin underscores the significant unmet need for new treatment options for people living with Alzheimer’s disease psychosis, a serious condition for which there are currently no FDA-approved therapies. This is an important milestone for the remlifanserin program,” Catherine Owen Adams, CEO of Acadia, said in a company press release.”
  • Parkinson’s News Today tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to sasineprocel (ANPD001), an experimental cell therapy to treat Parkinson’s disease.
    • “The designation, given to promising regenerative therapies (treatments that aim to replace or restore disease-damaged tissue) that could substantially improve care for serious diseases, provides developer Aspen Neuroscience with perks such as more intensive FDA guidance.
    • “This significant milestone highlights the transformative nature of sasineprocel as a potentially disease-modifying therapy for patients facing a serious disease with substantial unmet medical need,” Damien McDevitt, PhD, president and CEO of Aspen, said in a company press release.” 

From the judicial front,

  • Beckers Payer Issues reports,
    • “Five federal employees are suing U.S. Office of Personnel Management Director Scott Kupor over alleged sex discrimination due to the rollback of coverage for gender-affirming care.
    • “Plaintiffs, backed by the Human Rights Campaign Foundation, filed the lawsuit Aug. 3 in the U.S. District Court for the District of Columbia. The potential class action focuses on OPM’s coverage policy following a January 2025 executive order from President Donald Trump. The order said “sexes are not changeable,” and the country recognizes only male and female sexes.” * * *
    • “The lawsuit calls for two classes, one seeking injunctive relief and the other seeking damages. The complaint also requests retroactive coverage.”
  • STAT News relates,
    • “Sandoz agreed to pay $478.5 million to settle allegations by dozens of states and resellers of medicines that the company engaged in a widespread conspiracy to artificially inflate and manipulate prices of generic drugs and harmed consumers by reducing competition.
    • “Under one settlement, the company agreed to pay $400 million over seven years starting in 2027 to resolve all remaining claims by U.S. states in three pending cases and make an additional payment of about $50 million to states that settled earlier. Another $28.5 million will be paid to resolve all remaining class-action litigation brought by indirect resellers. Sandoz did not admit to any wrongdoing.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Two people have died in connection with the cyclosporiasis outbreak that has spread across the U.S. this summer, according to public-health officials in Michigan, marking the first deaths tied to the unusually large flare up of the food-borne illness.
    • “Both of the people had “significant underlying health conditions” that may have been exacerbated by cyclosporiasis and dehydration, Michigan’s Department of Health and Human Services said. It didn’t provide any additional information about the people who died but said cyclosporiasis deaths are uncommon in the United States.” * * *
    • “The Centers for Disease Control and Prevention said it has received reports of more than 6,700 laboratory-confirmed cases of cyclosporiasis, with another 11,500 suspected. Typically, the U.S. sees about 250 reported cases by this time of year.
    • “The exact source of the parasite remains unclear. Authorities have been probing various cyclospora outbreaks as if they are distinct, but it is possible they are related and investigators so far haven’t been able to connect them. Food-safety experts say the vast majority of fresh fruits and vegetables are still safe to eat.
    • “The largest outbreak has been linked to Taylor Farms’ shredded iceberg lettuce, which was sold at retailers including Taco Bell. On July 17, Taylor Farms said it was removing all iceberg lettuce sourced from central Mexico from the U.S. market. Taco Bell finished pulling potentially affected product from its supply chain on the same day. 
    • “Yum Brands, the parent company of Taco Bell, was in communication with Michigan public-health authorities weeks before the recall, according to emails the health department shared with The Wall Street Journal on Monday. 
    • “In an email to a Yum Brands employee on July 2, a state epidemiologist said the department had “a strong signal from our epidemiologic interviews that we need to continue to work with Taco Bell.” 
  • Fox Business relates,
    • “Marijuana is officially leading the pack for the most-used daily drug among Americans.
    • “New data from the 2025 National Survey on Drug Use and Health, from the Substance Abuse and Mental Health Services Administration (SAMHSA), reveals that there are 21.4 million daily or near-daily marijuana users in the U.S.
    • “This surpasses the 19.9 million people who smoke cigarettes and the 17.2 million who consume alcohol.” * * *
    • Although marijuana is now the most commonly used substance on a daily or near-daily basis, alcohol remains the most widely used substance overall. During the previous month, about 129 million people drank alcohol while 43.8 million used marijuana.
  • Cardiovascular Business tells us,
    • “Twenty years after its launch, the Get With The Guidelines-Heart Failure (GWTG-HF) registry from the American Heart Association (AHA) has grown into one of the nation’s most influential cardiovascular databases, helping accelerate the adoption of guideline-directed medical therapy (GDMT) while generating evidence that has reshaped heart failure care.
    • “Since its inception in 2005, the registry has collected more than 1.6 million patient records from more than 800 hospitals, representing about 60% of U.S. hospitals. The database has produced more than 150 peer-reviewed publications and is increasingly being used to support implementation science, registry-based clinical trials and long-term outcomes research.
    • “What started as a quality improvement initiative has led to substantially better processes of care and, most likely, improved survival, fewer symptoms and a tremendous learning platform,” Clyde W. Yancy, MD, MSc, chief of cardiology and professor of medicine at Northwestern University, said in a video interview with Cardiovascular Business.
    • “He added that the registry was created to solve a longstanding challenge in medicine: the fact that it often takes years for clinical evidence to truly influence changes in daily practice.” 
  • Drug Topics informs us,
    • “A survey study published in JAMA Network Open found that pregnant women and parents of young children generally prefer maternal respiratory syncytial virus (RSV) vaccination over infant RSV antibody shot administration as a means of protecting infants against RSV-associated hospitalization. The 2 concurrent national cross-sectional surveys, fielded in April 2024 among 174 pregnant women and 1765 parents of children aged 0 to 5 years, found that only about half of participants reported positive intentions toward either immunization option, underscoring a persistent gap between product availability and uptake.”
  • Fierce Healthcare lets us know,
    • “A new study evaluating the impact of virtual lactation support found it boosted maternal health and breastfeeding success outcomes. 
    • “The study evaluated SimpliFed, a virtual baby-feeding platform led by UMass Chan Medical School. Participants who completed three or more telelactation visits breastfed for nearly 16 weeks longer than those who did not engage with any visits. The impact was even more drastic for moms with mental health conditions, where average feeding duration increased by 24 weeks. The study, presented as a poster, is not yet published online.
    • “The researchers recruited a group of 200 participants from prenatal through postpartum. All were offered unlimited access to the SimpliFed platform for 12 months. Utilization was evenly split: a third did not complete any visits; a third completed one to two; and a third completed three or more.
    • “Dropping breastfeeding rates over time were common, mirroring national trends. Most participants, regardless of whether they engaged with SimpliFed, breastfed at one week postpartum; three-quarters did by six months; and about half did at 12 months. However, completing three or more SimpliFed visits led to longer duration of breastfeeding compared to others in the cohort.”
  • MedPage Today adds,
    • “A study of U.S. children found no evidence linking neonatal male circumcision with autism spectrum disorder, prospective data from the ECHO cohort showed.
    • “Among nearly 2,800 boys in 14 ECHO sites, 6% of those who were circumcised had autism compared with 9% of uncircumcised males, according to Monica McGrath, ScD, MHS, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and co-authors.
    • “After adjusting for confounders, circumcision was not associated with an autism diagnosis (OR 0.83, 95% CI 0.59-1.17), McGrath and colleagues reported in JAMA Pediatrics.
    • “Stratifying data by region, preterm birth, and neonatal intensive care unit (NICU) admission yielded either an inverse or no association. Circumcision also was not associated with autism-related traits or behaviors.”
  • Beckers Hospital Review points out,
    • “Active U.S. drug shortages increased to 227 in the second quarter of 2026, marking the third consecutive quarterly increase, according to the American Society of Health-System Pharmacists. Nearly half of all new shortages this year involve medications made by a single manufacturer, a concentration that increases supply chain vulnerability, and the FDA’s database continues to reflect new discontinuations weekly.”
    • The article identifies the nine drugs most recently placed in shortage status.

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

  • The Wall Street Journal reports,
    • “AstraZeneca AZN shares fell sharply and Bristol Myers Squibb’sBMY  climbed, after media reports that the two drugmakers held merger talks.
    • “London-listed shares in AstraZeneca were down 6.4% in European morning trading. Meanwhile, Bristol’s shares were up 5.5% in U.S. premarket trading.
    • “The stock moves came after the Financial Times reported, citing unnamed sources, that AstraZeneca held discussions with Bristol about a tie-up in recent months, which could lead to a deal in the near future or fall apart.
    • “An AstraZeneca spokesman declined to comment, while Bristol didn’t respond to a request for comment.
    • “A potential deal between AstraZeneca and Bristol Myers Squibb would create a pharma giant with a combined market value of roughly $400 billion and more than $100 billion in annual sales.”
  • Beckers Hospital Review relates,
    • :Gaithersburg, Md.-based Adventist HealthCare recorded operating income of $18.2 million (3% operating margin) through the first six months of fiscal 2026, up from an operating loss of $205,000 (-0.1% margin) during the same period last year, according to its July 29 financial report.” * * *
    • “Among the system’s hospitals, Silver Spring, Md.-based White Oak Medical Center posted $11.9 million in operating income through Q2, up from a $2.8 million operating loss during the same period last year. Rockville, Md.-based Shady Grove Medical Center posted $16.5 million in operating income, up from $10.2 million. Fort Washington (Md.) Medical Center Medical Center posted a $1.2 million operating loss, widened from a $960,000 loss during the same period last year.”  
  • Beckers Behavioral Health tells us,
    • “Ochsner Behavioral Health Acadiana welcomed its first patients July 8, marking the official launch of a regional behavioral health network built jointly by Ochsner Lafayette (La.) General and Plano, Texas-based Oceans Healthcare. 
    • “The network pairs a newly built hospital in Lafayette with the former Oceans Behavioral Hospital Broussard, now renamed Ochsner Behavioral Health Acadiana-Broussard, giving the partners 100 inpatient beds across the two campuses under a single license — more than double the 38 beds they previously operated in the region.
    • “The logic behind the partnership, Oceans Healthcare COO Jeff Pritchard said, comes down to completing the continuum.
    • “Many patients come through the doors of a health system; they have ERs, they have hospitals, they have various clinics,” he said. “By forging a connection with them, we can create a path to those patients who need behavioral health support, so there’s no loss of care in the transition.”
  • Cardiovascular Business informs us,
    • “Cleerly, a Denver-based artificial intelligence (AI) company, has partnered with New York-based Allelica to launch the new Cleerly Polygenic Cardiovascular Risk Score Test. 
    • “Allelica specializes in polygenic risk scores (PRS) that predict a patient’s genetic risk of developing different diseases. Cleerly, meanwhile, its known for its AI-powered coronary CT angiography (CCTA) evaluations. Together, these two companies have collaborated on a new test designed to help physicians diagnose and manage heart patients with suspected coronary artery disease.
    • “Genetic risk and imaging answer two different questions for a physician,” James K. Min, MD, FACC, FESC, MSCCT, founder and CEO of Cleerly, said in a statement. “Inherited risk points to who is biologically predisposed to coronary disease, and our imaging analysis shows what is actually present inside the arteries. Bringing those two views together gives physicians a clearer, more individualized picture of each patient’s coronary risk.”
  • Per BioPharma Dive,
    • “Brain drug developers Supernus and Individor on Monday announced plans to merge, bringing together two companies specializing in drugs for central nervous system disorders that had combined revenues of $2 billion in 2025.
    • “Per deal terms, Supernus shareholders will receive 1.54 shares of Individor for every Supernus share they own, and Individor shareholders will receive a one-time $1 billion cash dividend before the deal’s close, financed by a $650 million loan and the combined companies’ cash on hand. After the close, the former Individor shareholders will own around 57% of the combined company and Supernus’ will own around 43%.
    • “Following the close, the company will be called Supernus, headquartered at Supernus’ Rockville, Maryland offices, and will be headed by its current CEO, Jack Khattar. Individor board member Tony Kingsley will become the combined company’s board chair. The board is expected to consist of eight members evenly split between Individor and Supernus.”
  • Per MedTech Dive,
    • “Global investment firm KKR said Monday it has agreed to buy device manufacturer Integer Holdings for about $5.7 billion.
    • “The companies expect to close the deal before the end of the year, at which point Integer would become a private company. Shares of Integer rose by nearly 20% to $121.21 Friday afternoon following a Wall Street Journal report that the two companies were nearing a deal.
    • “Integer, which bills itself as one of the largest global medical device contract development and manufacturing organizations, expects the acquisition would provide flexibility and long-term capital to invest in its capacity, technology and innovation.”