Weekend update

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Weekend update

David Ermer–CDC, Congress, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • The Senate is in session this week on Capitol Hill this week (following the Jewish holiday Yom Kippur. which begins at a sundown Sunday) for Committee business and floor voting.
  • Roll Call shares more details on this week’s Senate activities.
  • MedPage Today reports,
    • “Landmark legislation designed to alert consumers to where their drugs were made is headed for a full Senate vote, but safety experts say the transparency bill has been stripped of two of its most critical provisions.
    • “The Clear Labels Act was introduced earlier this year by Sens. Rick Scott (R-Fla.) and Kirsten Gillibrand (D-N.Y.) after lawmakers and drug safety experts called for more transparency in the industry. Last year, a ProPublica investigation revealed that the U.S. kept importing generic drugs from foreign factories after inspectors had identified quality and safety lapses at the sites, including leaks, mold, and contaminated water.
    • ‘Medications made at these facilities were linked to thousands of reported adverse reactions in patients.
    • “The bill aims to allow doctors and patients to see on the label exactly where a medication was made — details that had largely been withheld until now, even from Congress. Current generic drug labels often include only the location of the packager or distributor, which can be thousands of miles away from the actual manufacturer.
    • “One provision made the law particularly strong, experts said: The label was supposed to include a unique code that the FDA uses to identify factories. That code would have made it easier for researchers and the public to track the regulatory histories of specific facilities.
    • “The requirements also were supposed to take effect as early as a year after the bill’s passage.
    • “Senators have now struck both of those provisions. People familiar with the deliberations said lawmakers worried the requirements would raise drug prices and weaken national security by revealing the precise locations where lifesaving medications are made.
    • “The unique identifier requirement has been removed from the bill, and the timeline for companies to come into compliance was extended to 5 years.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention is seeking public input on how data intermediaries, such as health information exchanges and other data-sharing entities, can support secure, scalable, standards-based public health data exchange. Comments submitted for the request for information will be used to evaluate ways to improve interoperability, reduce reporting burdens and enhance the timeliness and usefulness of data for public health while protecting privacy.
    • “CDC said the effort builds on its data modernization initiatives and seeks feedback on how intermediaries can help address ongoing challenges related to data silos and information sharing across the healthcare and public sectors. Comments are due by Nov. 20.”

From the judicial front,

  • Beckers Payer Issues reports,
    • “Several HCA Healthcare-affiliated hospitals in Texas filed a lawsuit Sept. 11 against Pennsylvania insurer Independence Blue Cross over alleged claim denials.
    • “The plaintiffs include Methodist Healthcare System of San Antonio, St. David’s HealthCare, HCA Houston Healthcare North Cypress, The Woman’s Hospital of Texas and HCA Houston Healthcare Medical Center — all tied to Nashville, Tenn.-based HCA Healthcare.
    • “The lawsuit, filed in a Pennsylvania federal court, argued the insurer needed to reimburse these hospitals under the BlueCard Program, which allows members of one Blue Cross Blue Shield Association licensee plan to receive covered care access in another licensee’s service area. In this case, the hospitals contract with BCBS Texas. The complaint also said IBX represented the hospitals as “in network.”
    • “The complaint said IBX owes the hospitals at least $345,319 under the agreements. The lawsuit outlines alternative legal theories, such as “implied-in-fact contract,” to challenge IBX’s reimbursement approach, as well.”
  • The Wall Street Journal relates,
    • “Michelle Fennell was sitting at her desk when her right eye started feeling heavy. Suddenly, it was blurry and her peripheral vision waned. It felt like she was looking through a fishbowl; she could see straight ahead but not to her right or down. 
    • “Two weeks later, a doctor diagnosed Fennell, 53 years old, with nonarteritic anterior ischemic optic neuropathy, or NAION, a condition that leads to sudden, often permanent vision loss.
    • “The doctor asked what medicines she was taking. “He said right away, stop taking Ozempic,” to protect her remaining vision, said Fennell, who started taking the drug to treat her Type 2 diabetes six months prior. “I was shocked.” 
    • “Some emerging scientific research points to an increased risk for patients taking certain GLP-1s to develop NAION. But the evidence is mixed, and not clear enough to say whether or how the drugs cause the condition, doctors and researchers said.
    • “Fennell is one of dozens of people suing Novo, maker of the popular weight-loss and diabetes drugs Wegovy and Ozempic, claiming the medication caused this side effect. There are also a similar but smaller number of lawsuits against Eli Lilly, maker of Zepbound. Both companies are fighting the litigation, saying there isn’t enough evidence to support the idea that drugs are to blame.”

From the public health and medical / Rx research front,

  • The Hill reports,
    • “Doctors in Texas say they have seen an increasing number of otherwise healthy young men coming in on the brink of organ failure. 
    • “The health care practitioners told Texas Monthly they believe the culprit is CKDu, or chronic kidney disease of unknown origin, an unexplained form of kidney disease that can quickly turn deadly.
    • The disease has also been called Mesoamerican Nephropathy, a reference to the region it’s more typically found in, Central America. It’s also been identified in Sri Lanka. Researchers are now concerned it is growing in the United States, especially among agricultural workers and laborers. 
    • People with CKDu don’t have the classic risk factors of kidney disease, like hypertension or diabetes. Most people affected by the disease are Latino men ages 20 to 60. Often, they work under extreme conditions.
  • The Washington Post relates,
    • “The reported success of an experimental drug that uses messenger RNA to deliver personalized skin cancer vaccines could herald a wave of new treatments that harness the potent technology for a range of cancers, researchers say.
    • “Drugmakers Moderna and Merck this summer announced that a cancer vaccine, intismeran autogene, had succeeded in a Phase 3 clinical trial in preventing the recurrence of melanoma, a result experts celebrated as a breakthrough for mRNA-based cancer treatments. 
    • “Trials investigating mRNA vaccines for lung cancer, pancreatic cancer and other diseases are already underway. They use the same approach as intismeran that might once have seemed like science fiction: analyzing a tumor sample to create a vaccine customized to target its specific mutations, so each patient receives a unique drug for their cancer.
    • “Some of these treatments are still years or decades from fruition, if they prove to be effective, but researchers said the still-nascent field of mRNA vaccines could eventually transform our approach to cancer care.
    • “It is not too far-fetched to consider that in the future, when one is diagnosed with cancer, part of your specimen is going to go to the pathologist, who’s going to confirm the cancer [diagnosis],” said Dan Costin, director of the White Plains Hospital Center for Cancer Care in New York and a lead investigator in an mRNA lung cancer vaccine trial. “And the other part will be going to a laboratory where they will be preparing a special vaccine.”
  • Medscape tells us,
    • “GLP-1 medicines for weight loss do cause some muscle loss, but current research suggests this is usually a normal part of losing weight and not unique to these drugs. The debate is really about how careful we should be in older or already frail people.
    • What happens to muscle with GLP-1 weight loss?
      • GLP-1 drugs (like semaglutide and tirzepatide) lead to large weight loss; about one-quarter to one‑third of that loss is “lean mass,” which includes muscle, organs, water, and bone, not just muscle alone.1When researchers adjust for the non‑muscle parts of fat tissue, the estimated lean loss with semaglutide drops from 39% of total weight lost to about 30%.2 Studies of people losing similar amounts of weight with bariatric surgery show a very wide range of lean‑mass loss (about 12–44%), so GLP‑1 drugs do not appear to cause an unusual or “extra harmful” pattern compared with other ways of losing weight.1 Importantly, in trials where people lost a lot of weight on GLP‑1s, physical function and mobility usually improved, even though some lean mass was lost.
    • Who might need extra caution?
      • Experts agree most typical middle‑aged adults with obesity are not becoming frail from GLP‑1 treatment.1 Concern is higher for: –
        • Older adults, especially over 60 –
        • Post‑menopausal women – P
        • People with sarcopenic obesity (high fat, low muscle) or other illnesses (heart disease, fatty liver, sleep apnea, major weight cycling)1
      • In these groups, losing too much muscle could worsen balance, strength, and fracture risk.
  • Health Day informs us,
    • “Getting enough sleep is important for your health — but the type of sleep you get may matter, too.
    • “A team led by Jingsong Luo of Peking University in China tracked more than 95,000 adults who wore wrist monitors for seven days and nights, measuring REM, deep sleep and light sleep.
    • “Over the next nine years, they checked health records for links to more than 1,000 different diseases.
    • “The result: More REM sleep was linked to a lower risk of 83 diseases, including heart failure, dementia, Parkinson’s, Alzheimer’s and multiple sclerosis.
    • “More deep sleep was tied to lower risk of seven conditions, including type 2 diabetes, major depression and sleep apnea.
    • “REM sleep is when most dreaming happens, while deep sleep is the most restorative stage.
    • “The findings also underscore the importance of getting six to eight hours of sleep a night.”

From the U.S. healthcare business front,

  • Beckers Clinical Leadership discusses better ways for our health system to handle chronic illnesses.
    • “[A]dvances – nutritional interventions, bioelectronic medicine, robotics, community-based care – are not isolated innovations. Together, they represent a strategy to reduce the burden of chronic disease on the more than 190 million Americans living with it today. When prevention works, the cost of care comes down. When communities are healthier, demand for expensive interventions falls.
    • “The path forward is clear, even if it isn’t easy. Chronic disease will not be tamed by any single breakthrough. It will be tamed by a sustained, systemwide commitment to prevention – investing in food, technology, relationships and community before a patient ever needs a hospital bed. Every health system, payer and policymaker should be asking the same question we ask ourselves: are we doing everything we can to keep people healthy before they need us? That is where the opportunity is. And that is where we intend to lead.”
  • Beckers Payer Issues relates,
    • “Marisa Rogers, MD, has left her role as chief medical officer for Oak Street Health, CVS Health’s primary care company for older adults.
    • “We built our clinical teams, invested in our leaders, advanced our care model, improved quality, and navigated more change and transformation than I could have imagined,” Dr. Rogers said in a Sept. 18 LinkedIn post. “I’m proud of what we accomplished together and even more grateful for the people I shared it with.”
  • Healthcare Dive reports,
    • “Almost 12 million Americans can’t access telehealth services because they don’t have enough broadband to support a reliable virtual care connection, according to new research published Friday in JAMA Health Forum.
    • “The majority of impacted individuals live in rural areas, highlighting how inadequate infrastructure and pricey broadband subscription rates are preventing traditionally underserved Americans from getting virtual access to primary, specialty and emergency care, researchers with the University of Vermont said.
    • “Affordability, low digital literacy, inadequate technology and a lack of availability of telehealth services are also hindering telehealth access.’

Thursday report

David Ermer–ACA, Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, Patient safety, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Modern Healthcare reports.
    • “Congress extended most annually funded healthcare programs through December, setting a likely end-of-year deadline for action.
    • “Lawmakers will have to decide which stalled health initiatives, from prior-authorization rules to transparency measures, would advance alongside must-pass extensions.
    • “Anti-fraud proposals could provide budgetary offsets to fund more expensive measures like a new Medicare physician payment system.”
  • Beckers Hospital Review relates,
    • “The Trump administration says it will mail $500 checks to nearly one million Americans in 30 states to refund what it called “overcharges” from ACA exchange fees collected under the Biden administration.
    • “On Sept. 10, the White House said insurers that sell plans on the federal exchange pay user fees to fund the platform’s operations, and that those fees generated a surplus that was never returned to consumers. The refunds, which are set to go out starting in October, will be provided to enrollees who did not receive premium tax credit assistance and paid the full cost of their premiums.” 
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced awards to 132 hospitals totaling nearly $25 million through the Rural Hospital Provider Assistance Program to help eligible small rural hospitals maintain their medical workforce, sustain essential healthcare services, and strengthen access to care for the communities they serve across 13 states.” * * *
    • “Awarded hospitals may use this funding to retain physicians, nurses, and other healthcare providers, allowing hospitals to preserve essential services, including emergency, inpatient, and other critical healthcare services. This support helps ensure rural communities can continue to access affordable care when and where they need it.
    • “A complete list of award recipients and more information about the program is available at Rural Hospital Provider Support Program FY 2026 Grant Awards.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that an $11.7 million investment is being delivered to support rural nursing care facilities and strengthen the healthcare workforce across rural communities in Vermont through the federal Rural Health Transformation Program (RHTP). Of this, Vermont is committing $9 million of those funds to provide tuition benefits to healthcare professionals in underserved or hard-to-fill positions who commit to serving rural communities within the state for at least five years after graduation. The remaining $2.7 million provides funding for three rural nursing homes to increase their capacity to serve residents with complex medical issues and four community partners to increase training of Licensed Nursing Assistants (LNA) to serve in rural healthcare and long-term care settings across the state.”
  • Cardiovascular Business relates,
    • “On Thursday, Sept. 10, CMS officially finalized a new national coverage determination (NCD) for TAVR. Arguably the biggest change is that TAVR will now be covered in Medicare beneficiaries who present with asymptomatic severe aortic stenosis (AS). The treatment of asymptomatic patients has been a hot topic in recent years. Some specialists see it as a way to treat patients early and avoid long-term damage. Others disagree, preferring to save TAVR for patients who present with symptoms. 
    • “Another key update is that Medicare beneficiaries with symptomatic severe AS is now covered without any sort of coverage with evidence development (CED) requirements. The TAVR NCD has always required facilities performing TAVR to follow certain CED rules that require patient data to be collected through clinical trials or registries. This is no longer the case when it comes to performing TAVR on symptomatic patients. 
    • “Five leading U.S. medical societies—the American Association for Thoracic Surgery, American College of Cardiology, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions and Society of Thoracic Surgeons—did work together to argue that CED requirements should still be in place, but CMS still moved forward with that particular proposal. 
    • “It is worth noting, however, that CED requirements are still in place when it comes to performing TAVR on asymptomatic patients.”
  • The American Hospital Association News tells us,
    • “The National Institutes of Health has launched its Connecting the Community for Maternal Health Challenge: Research Capacity Building in Maternity Care Deserts 2.0. The competition will award more than $3 million to encourage and reward biomedical research in maternal health with an emphasis on maternal morbidity and mortality and maternal health deserts. The challenge consists of four phases: recruitment, training, proposal and research. The recruitment phase closes Sept. 23 and is required to be eligible for later phases. If selected, participants in each phase will be considered for awards ranging from $10,000 to $300,000.”
  • and
    • “The Federal Trade Commission announced Sept. 9 that it rescinded its 2021 policy statement that extended applicability of its health breach notification rule to health apps and connected devices that collect consumer health information. The commission said the 2021 statement was superseded by its 2024 update to the health breach notification rule. The FTC said the recission is part of the administration’s deregulation efforts and follows the commission’s policy of avoiding unnecessary use of subregulatory guidance.”
  • Fierce Healthcare relates,
    • “Federal healthcare agencies are accelerating efforts to expand artificial intelligence’s role in healthcare, with clinical AI emerging as a top strategic priority for the Centers for Medicare & Medicaid Services.
    • “At a healthcare AI event hosted by the Consumer Technology Association (CTA) in Washington, D.C., on Wednesday, Stephanie Carlton, deputy administrator at CMS, outlined the agency’s evolving AI strategy as it aims to establish clearer pathways for AI market access and regulation while also exploring reimbursement frameworks for AI-enabled technologies.
    • “Carlton also serves as chief clinical AI officer at CMS, a newly created position that signals the Trump administration’s push to advance AI in clinical care.
    • “A centerpiece of CMS’ AI strategy is the ACCESS model—Advancing Chronic Care with Effective, Scalable Solutions. Carlton hinted that the agency would soon expand that model. Announced in December and launched in July, ACCESS is a new 10-year program for value-based chronic condition management that leans heavily on technology and AI to scale to large populations of patients.”
  • Healthcare Dive tells us,
    • “The Department of Veterans Affairs has selected Amwell to facilitate telehealth delivery across the agency.  
    • “Amwell’s platform, which mainly offers virtual health visits, will help veterans connect with VA providers or other specialists in clinic. It will also support other telehealth services, such as virtual care delivery and care coordination within VA hospitals. 
    • “The VA signed a letter of intent to implement Amwell’s platform. A binding contract will depend on Amwell satisfying federal requirements, including a review by the VA’s chief information officer.”
  • Per an Institute for Clincical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will develop a special report for the Centers for Medicare & Medicaid Services (CMS) on darolutamide (Nubeqa®, Bayer) for treatment of prostate cancer. This report will be submitted to CMS as part of the 2027 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2029. 
    • “While the final list of drugs subject to negotiation will not be released until February 2027, ICER is developing this report with the expectation that darolutamide will be subject to negotiation next year. The report will reflect legislative specifications in the Inflation Reduction Act and the most recent CMS guidance regarding price negotiations.
    • “ICER’s expertise in comparative clinical effectiveness and value will continue to help inform the important conversations around Medicare drug price negotiation,” said ICER’s President and CEO Sarah K. Emond, MPP. “While we know CMS may consider many different factors and inputs during negotiations, we believe ICER’s approach to applying the guidance in a consistent framework offers important information to all stakeholders engaged in this process.”
    • “The research protocol is now available.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“

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

  • Federal News Network reports,
    • “It may not come as a surprise that Americans’ trust in government has declined over the last several decades. When the first systematic measurement was taken by the National Election Study in 1958, about 75 percent of Americans said they trusted their government.
    • “Today that number has basically inverted, sitting at a discouraging 27 percent, according to the annual survey by the Partnership for Public Service.
    • “The unexpected news may not be Americans’ low confidence in government as much as how they report feeling about the federal employees who work for it. The same survey found that 65 percent of Americans view federal workers as competent, even while giving low marks to government as a single entity. Even more favorable, public perception of the federal workforce is the highest it’s been since the Partnership first asked the question in 2021.”
  • and
    • interviews a financial expert about the F Fund available in the Thrift Savings Plan.
      • “The TSP’s F Fund has trailed the G Fund over the last several years. Before deciding what that means for your own investments, it helps to understand what’s happening in the bond market.”

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Salmonella Bovismorbificans infections linked to recalled broccoli sprouts grown by Evergreen Fresh Sprouts, LLC of Moyie Springs, ID. This outbreak is currently being investigated separately from the shiga toxin-producing E. coli and Salmonella outbreak linked to alfalfa sprouts also being investigated by FDA, CDC, and state partners.
    • “Based on epidemiological information collected by CDC and state partners, a total of 22 people infected with the outbreak strain of Salmonella have been reported from four states. Illnesses started on dates ranging from July 7, 2026, to August 26, 2026. Of the 19 people interviewed, all 19 (100%) reported eating sprouts and 17 (89%) reported specifically eating broccoli sprouts. There have been two hospitalizations and no deaths.
    • “FDA’s and state partners’ traceback investigations have identified Evergreen Fresh Sprouts, LLC as the common grower of broccoli sprouts that were eaten by patients before becoming ill. On September 4, 2026, Evergreen Fresh Sprouts, LLC initiated a recall of broccoli sprouts based on a positive Salmonella result from a broccoli sprouts sample collected and analyzed by Montana state officials. According to whole genome sequencing analysis conducted by state partners and reviewed by FDA, the positive sample is the same strain of Salmonella that is causing illnesses in this outbreak. Consumers, restaurants, and retailers should not eat, sell, or serve recalled broccoli sprouts grown by Evergreen Fresh Sprouts, LLC with expiration dates of 9/7, 9/9, 9/11, 9/14, and 9/16.”
  • The Washington Post reports,
    • “Federal officials are poised to declare the end of the nation’s largest known cyclosporiasis outbreak after thousands of people became sick after eating shredded iceberg lettuce, according to two people familiar with the matter.
    • “The update may come as soon as later Thursday, according to the people, who spoke on the condition of anonymity to discuss an ongoing investigation. However, the timing is not guaranteed. In mid-July, Taylor Farms voluntarily recalled products from the market as federal officials began linking its lettuce from central Mexico to a cyclosporiasis outbreak. Food and Drug Administration enforcement records show recalled products were packaged for nine food service and retail operations, such as Subway and Yum Brands, which owns Taco Bell, KFC and Pizza Hut.”
  • BioPharma Dive relates.
    • Biohaven shares fell by more than 10% Thursday after the company revealed that the Food and Drug Administration has placed a partial hold on an experimental epilepsy medicine it recently sold off rights to in a licensing deal.
    • In a regulatory filing, Biohaven disclosed that the FDA has requested additional data related to a “metabolite,” or drug-related substance, that was identified in rodent studies of its treatment opakalim. The agency instructed Biohaven to pause recruitment in an ongoing late-stage trial until it can provide more information. Dosing will continue for those already involved in that study, “RISE-2.”
    • Importantly, the hold doesn’t affect a separate late-stage trial, “RISE-3,” that’s fully enrolled. That study is still expected to produce results later this year in what is a “key event” for Biohaven, wrote William Blair analyst Myles Minter. Should opakalim succeed in testing and win approval, Biohaven will be eligible for milestone payments and sales royalties from licensing partner SK Pharmaceuticals.

No Surprises Act News

  • Modern Healthcare reports,
    • “A group of nearly 70 employers, unions, patient advocates and other organizations is calling on Congress to rework the No Surprises Act of 2020. 
    • “The letter, led by left-leaning advocacy group Families USA and cosigned by 67 organizations, asked congressional leaders to address concerns about the law’s Independent Dispute Resolution process.
    • “Under the No Surprises Act, IDR arbitrators determine appropriate out-of-network reimbursement rates, with claims predominantly filed by providers or their aligned companies.” * * *
    • “Letter signers are calling on Congress to replace what they call the “baseball-style” arbitration process with a benchmark payment methodology that promotes market-based prices and discourages excessive reimbursement. 
    • “In an accompanying report, Families USA is also advocating for subjecting ground ambulance services to the law’s requirements; strengthening the federal process for certifying mediators; and requiring arbitrators to disclose their ownership structures, payment agreements and dispute outcomes information.” 

From the fraud, waste, and abuse front,

  • Per a Justice Department news release,
    • “Dompé U.S. Inc. (Dompé), based in California, has agreed to pay $32 million to resolve allegations that, between 2018 and 2021, it paid Medicare beneficiary co-pays through two patient assistance foundations to induce the purchase of its drug, Oxervate, in violation of the Anti-Kickback Statute and the False Claims Act.”
    • The claims resolved by the settlement are allegations only and there has been no determination of liability.

From the public health and medical / Rx research front

  • MedCity News reports,
    • “Heart disease is the leading cause of death among women in the United States, yet it remains chronically underrecognized, underdiagnosed and undertreated in this population. According to research from the American Heart Association (AHA), by the year 2050, the rate of total cardiovascular disease (CVD) in women will rise to 14.4%, a 3.7% increase from 2020 data.
    • “Data for reproductive age women (ages 20 to 44) shows a similarly troubling increase, from 1 in 4 in 2020 to nearly 1 in 3 in 2050 having clinical CVD. Diabetes in this same young age group is also projected to more than double, from 6% to nearly 16%.
    • “A critical opportunity exists at the intersection of prevention and rapid diagnostics in women’s health. Early intervention based on accurate diagnosis of both metabolic risk factors and acute cardiac events could help make the difference between life and death for women.”
  • Cardiovascular Business adds,
    • “Too much light exposure at night, both when asleep and awake, may be bad for the heart. That was the eye-opening takeaway from a new study published in European Heart Journal.
    • “Previous observational studies have linked nighttime light exposure with a higher risk of cardiovascular disease, but little is known about the related cardiac structure and functional changes,” senior author Lu Qi, MD, PhD, a researcher with Tulane University, said in a statement. “We carried out this research to find out what happens to the heart over time when people are exposed to too much light at nighttime.”
    • “Qi et al. tracked data from more than 11,000 UK Biobank participants. They wore a light sensor on their wrists for seven days. Three years later, they all underwent a cardiac MRI scan.
    • “Overall, study participants exposed to the most light—three lux or more—were associated with thickening of the wall of the left ventricle not seen in participants exposed to lower amounts of light. MRI results also showed that participants exposed to high amounts of light were experiencing issues with their heart muscle’s ability to flex during heartbeats, an early sign of heart damage.  
  • The New York Times relates,
    • “In the last few years, there’s been a cultural push for women in midlife to build strong bones.
    • “Menopause influencers and medical organizations alike have focused on the message that women’s risk for fractures increases dramatically after menopause, and that they should think about their bone density much earlier than their mothers might have.
    • “The American Medical Association recommends that women get their first DEXA scan — a low-dose X-ray that is the gold standard test for determining bone density — at 65 or older, unless they have a risk factor for osteoporosis.
    • “But a growing number of doctors and bone health experts now recommend earlier scans. They argue that if women wait until 65, they may miss a critical window to prevent osteoporosis.” The article delves into the details of this issue.
  • MedPage Today lets us know,
    • “People who consumed their hot beverages at a “very hot” temperature had a threefold higher risk for squamous cell carcinoma of the esophagus compared with those who drank them at a “warm” temperature, an analysis of two large U.K. cohorts suggested.”
  • and
    • “Borderline anemia — hemoglobin levels 0 to 1 g/dL above the WHO threshold — was associated with a higher risk of mortality, a prospective cohort study suggested.
    • “When stratifying results by age and sex, borderline anemia was associated with higher risks for all-cause, cardiovascular, and cancer mortality in men of all ages and in women 60 and older.
    • “These findings suggest that the relationship between hemoglobin concentration and long-term health cannot be captured by a single diagnostic cutoff, researchers said.”
  • The Washington Post tells us,
    • “People tend to think about supplements the way they think about food: Things that are inherently good or bad for you. Green beans are good. Potato chips are bad. Vitamin D and fish oil belong, presumably, on the green-bean side of the ledger.
    • “But the aging brain may change the calculation, putting some of America’s most popular supplements under new scrutiny.
    • “Recent research is raising a largely overlooked question: Can something that benefits (or is at least neutral to) a young, healthy brain become less helpful — or even harmful — as the brain ages?”
    • “In January, researchers reported an association between vitamin D supplement use and faster cognitive decline among older adults who already had normal vitamin D blood levels. In April, another study found that adults 55 and older taking omega-3 supplements showed greater cognitive deterioration over time than nonusers. Then, in June, researchers reported that people taking glucosamine, used for joint pain, appeared to have a much higher likelihood of progressing from mild cognitive impairment to dementia over five years than their peers who were not taking it.
    • “I was stunned,” said Ramon Sun, a professor of biochemistry and molecular biology at the University of Florida and the lead author of the glucosamine paper.” * * *
    • “The studies are mostly observational, meaning they don’t prove causation, and those links with mental deterioration may be because of the supplements or something else entirely.
    • “But together they point toward a possibility that researchers are beginning to take seriously: Aging changes how the brain handles fats, calcium and glucose, and how it responds to inflammation, which could alter how nutrients and drugs reach brain tissue in the first place.”
  • Beckers Health IT informs us,
    • “The American Heart Association’s PREVENT cardiovascular risk equations is now integrated into Epic’s EHR platform.
    • “The integration brings the cardiovascular risk assessment tool into clinicians’ existing workflows, where it can be used to estimate patients’ risk for heart attack, stroke and heart failure and inform prevention and treatment discussions.
    • “The PREVENT equations incorporate measures of cardiovascular, kidney and metabolic health and provide estimates of cardiovascular disease risk over 10- and 30-year periods. The tool is intended for adults ages 30 to 79 without a history of cardiovascular disease, according to a Sept. 10 news release.
    • “The equations were developed using health information from more than 6.5 million adults from a range of racial, ethnic, geographic and socioeconomic backgrounds, according to the association.”
    • “Recent American Heart Association and American College of Cardiology guidelines for managing high blood pressure, abnormal cholesterol and cardiovascular-kidney-metabolic syndrome recommend use of the PREVENT equations for cardiovascular risk assessment and treatment decisions.
    • “Embedding the equations within Epic is intended to make the risk estimates available at the point of care without requiring clinicians to use a separate tool, according to the association.”
  • Beckers Hospital Review points out,
    • “Among 31 cancer centers, 100% said they were experiencing a shortage of at least one anti-cancer drug, according to data published Sept. 10 by the National Comprehensive Cancer Network.
    • “The data summarizes August survey responses from pharmacy directors and other clinical and administrative leaders at 31 NCCN members, a Sept. 10 news release said.”

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

  • Healthcare Dive reports,
    • “Medicare Advantage insurers could see their star ratings fall next year — and lose out on the lucrative bonuses the ratings represent — after regulators boosted many of the thresholds for achieving the quality scores.
    • “Earlier this week, the CMS released draft cutpoints, the thresholds the agency uses to convert MA plans’ quality and performance scores into a 1 to 5 star rating, as part of the preview process before regulators announce official results in early October.
    • “About 50% of cutpoints got harder, 33% were unchanged and 17% actually got easier, according to analysis by the Newton Smith Group, an MA consultancy.”
  • Health Exec relates,
    • “For certain aspects of healthcare, Arizona is the freest state in the nation. The least free? New Jersey.
    • “The findings have nothing to do with no-cost services and everything to do with the legal, regulatory and policy environments governing healthcare across the United States. 
    • “They’re from the Center for Modern Health, a libertarian think tank focused on advancing free-market ideas in health policy.
    • “In the Center’s own words, the 2026 Health Freedom Index reflects state-level data on the degree of choice and freedom available to patients, healthcare professionals, insurers and entrepreneurs. 
    • “For each state, the project’s researchers measured performance across 54 variables and five kinds of “freedom”—professional, institutional, patient, payment and delivery—and used the sums to index the states from best to worst. 
    • “In addition, the project “aims to promote transparency and informed discussion about the role of freedom, voluntary exchange and institutional design in American healthcare.”
  • Beckers Hospital Review points out the top rehabilitation hospital in each State based on U.S. News & World Report compilation of a list of the top rehabilitation hospitals in every state. 
  • The Wall Street Journal informs us,
    • “An Association for Accessible Medicines report says 90% of biologic drugs losing patent protection by 2034 have no biosimilars in development.
    • “The lack of low-cost alternatives could cost Americans nearly $200 billion in healthcare savings over the next decade.
    • “The dispensing rate of available biosimilars over brand-name drugs fell to 23% in 2025, down from about 40% in 2024.”
  • STAT News notes,
    • “When Kura Oncology decided to take aim at a protein involved in cell division and signaling, researchers reported a bonus finding: Targeting the protein, menin, didn’t just control the growth of leukemia cells, it also helped control blood sugar levels in animal studies. The biotech on Wednesday announced that it is turning that insight into a new company.
    • “The new firm, Caspian Therapeutics, is launching with $50 million in financing to develop menin inhibitors for diabetes and other cardiometabolic diseases. The initial funding, led by BVF Partners and joined by Eli Lilly and members of Kura’s leadership team, among others, is meant to advance Caspian’s lead small molecule drug through an early-phase clinical trial in diabetes and support the development of a second candidate.”
  • Per Beckers Physician Leadership,
    • “Physician assistants averaged a salary of $155,000 in 2026, continuing a run of steady raises since 2022, according to a report from Medscape.
    • “The topline number hides a more complicated picture: pay growth varies widely by specialty setting, state and gender, and base salary itself grew more slowly than the bonus and incentive pay layered on top of it.”
  • Per Fierce Healthcare,
    • “Electronic prescribing platform Interra Health announced Tuesday that it now supports the U.S. Centers for Medicare and Medicaid Services’ (CMS) GLP-1 Bridge program for Medicare Part D beneficiaries.
    • “Eligible Part D enrollees can access GLP-1 medications at $50 per month through the program, which launched July 1. For Interra patients, the platform alerts providers when patients may be eligible to enroll in the program. Moreover, it instructs providers to submit proper codes and complete required prior authorizations.
    • “Interra Health Chief Business Development Officer J.B. Powell told Fierce Healthcare the program has delivered “more than 170,000 point-of-prescribing alerts to more than 30,000 unique prescribers” since its launch, adding that its requirements could “be confusing” for providers and patients to understand eligibility.”
  • and
    • “Plans to build a new, $2 billion-plus patient care tower and other accompanying upgrades at the University of Iowa Health Care’s main campus are off the table in favor of smaller-scale upgrades to existing facilities, the academic system said Wednesday. 
    • “Iowa Health Care had previously described the new patient tower as “critical to our ability to meet the healthcare needs of Iowans for years to come.” Primary construction wasn’t scheduled to begin in earnest until 2028 and targeted a 2032 completion.
    • “The organization is still facing a capacity crunch, noting in Wednesday’s announcement that it turns away 3,000 to 5,000 patient transfers a year “due to space constraints” even as it recorded over 41,000 inpatient admissions, almost 1.7 million clinical visits and over 43,000 major surgeries last fiscal year. 
    • “However, “significant financial challenges” facing the healthcare industry at large have limited Iowa Health Care’s ability to “responsibly” deploy capital toward the project. The organization stressed that its finances are stable, but now plans to submit a revised $380 million capital plan to its board later this month.”

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Department of Health and Human Services announced Sept. 8 through the Substance Abuse and Mental Health Services Administration that it will award $383.4 million in grants to support behavioral health treatment, prevention and crisis response efforts. HHS said $252 million will support the 988 Suicide and Crisis Lifeline, suicide prevention and mobile crisis services. Of the remaining grants, $81.4 million will be used toward substance use treatment and prevention initiatives, and $50 million will be used to support mental health services. The Sept. 8 announcement coincided with 988 Day, which raises awareness about the 988 lifeline and the importance of mental health and suicide prevention.” 
  • Bloomber Law reports,
    • “The Trump administration is pursuing additional drug pricing deals with pharmaceutical companies, Centers for Medicare and Medicaid Services Administrator Mehmet Oz told Bloomberg Television.
    • “Officials have announced more than two dozen voluntary agreements with pharmaceutical companies so far, and Oz said “there are more deals in the works.” He spoke ahead of his scheduled keynote address at the Republican midterm convention in Dallas Wednesday night.
    • “Each of the agreements is bespoke, but companies generally have agreed to lower the prices they charge public programs for medicines and to launch new drugs at prices similar to those paid by other developed nations in exchange for relief from tariffs. Some companies also are offering the discounted prices directly to consumers on a Trump-branded website, though critics argue the savings are minimal for patients with insurance.”
  • Axios adds,
    • “There are troubling new signs that the overhaul of Medicare drug coverage in the Inflation Reduction Act is dramatically driving up program spending. 
    • “Why it matters: The upward trajectory could threaten some seniors’ coverage for outpatient prescription drugs — and it could force painful tradeoffs over the next decade as Medicare consumes a growing share of the nation’s debt. 
    • “Follow the money: The IRA limited what seniors have to pay for outpatient drugs and shifted the remaining cost to taxpayers, insurers who provide stand-alone Medicare drug plans and drug manufacturers.
    • That was good news for enrollees who take expensive drugs for conditions like cancer, multiple sclerosis or rheumatoid arthritis and faced potentially crushing out-of-pocket costs.
    • But federal data shows demand for drugs is surging as they become more affordable, exceeding congressional scorekeepers’ spending estimates and setting off more alarms.
    • “Driving the news: Last week, congressional Medicare advisers reported that more than 1 in 5 enrollees hit Medicare Part D’s $2,000 patient cost cap in 2025 — shifting new costs to the government.”
  • Beckers Behavioral Health breaks down the Labor Department’s September 8 enforcement guidance concerning the mental health parity act into seven things to know:
    • “Certain behavioral health treatment exclusions could draw scrutiny.
    • “Prior authorization and medical necessity processes are a key enforcement area.
    • “The agency is looking closely at behavioral health networks.
    • “Compliance depends on how policies operate in practice.
    • “Telehealth, cost-sharing and visit limits can also raise compliance concerns.
    • “Plans are expected to use monitoring mechanisms to identify disparities.
    • “Corrective actions can require changes to coverage and plan operations.”
  • STAT News relates,
    • “ARPA-H, the government agency that funds cutting-edge health research, plans to commit $62.7 million to develop artificial intelligence bots that direct treatment of heart failure. Among the goals of the program, called ADVOCATE, is to produce partially autonomous AI devices authorized by the Food and Drug Administration to help treat patients, including assessing symptom severity, prescribing drugs, and ordering lab tests. 
    • “ARPA-H on Wednesday announced the first batch of awards to health tech companies Atman Health, UpDoc, Tempus AI, and teams from Stanford University, Duke University, and the Kaiser Permanente health system. ARPA-H may still fund additional teams. The amount committed for the first year is $33.7 million, and the remainder may be renegotiated up or down.” 

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

  • My Federal Retirement tells us about “What FEHB Enrollees Should Know if They Get a Letter from Medicare This Month.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “In an accelerated decision, the FDA expanded Bayer’s Hyrnuo indication, granting first-line approval for a rare tumor type in patients with non-small cell lung cancer. 
    • “Before the expansion, Hyrnuo was available only after other NSCLC treatments failed. But the FDA’s latest go-ahead makes the tyrosine kinase inhibitor (TKI) an initial therapy option for any patient with locally advanced or metastatic non-squamous NSCLC whose tumors test positive for HER2 tyrosine kinase domain activating mutations.   
    • “The expanded indication was won using data from Bayer’s ongoing phase 1/2 Soho-01 trial, in which Hyrnuo demonstrated a 75% objective response rate in previously untreated patients. Six percent of patients showed a complete response, and 70% showed a partial response to the twice-daily oral medication, Bayer said Wednesday. Responses lasted more than six months for 73% of patients.”
  • and
    • “With a phase 3 win now fleshed out and an FDA filing recently submitted, BioMarin is advancing expansion plans for Voxzogo, looking to extend the dwarfism drug’s reach as it faces new pressure in its inaugural achondroplasia indication. 
    • “On Wednesday, BioMarin unveiled detailed results from the phase 3 CANOPY-HCH-3 trial assessing Voxzogo in children with hypochondroplasia (HCH), a milder form of achondroplasia, where the company announced a topline win back in May. 
    • “Aside from the average 2.33 cm/year improvement in annualized growth velocity (AGV) on Voxzogo that BioMarin reported out earlier this year, the company dug deeper into the magnitude of benefit its medicine could offer to children with HCH across measures like standing height and arm span after a year of treatment.
    • “BioMarin shared the data Wednesday at the European Society for Paediatric Endocrinology annual meeting and simultaneously published the results in the New England Journal of Medicine.” 
  • Cardiovascular Business points out,
    • “Luma Vision, an Irish medtech company focused on electrophysiology and interventional cardiology technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its updated Verafeye imaging and visualization platform. The company previously received FDA clearance for the artificial intelligence-powered offering in 2025; this update covers the platform’s expanded capabilities ahead of a planned commercial launch in 2027.
    • “The Verafeye platform provides ultrasound imaging courtesy of a 360° catheter that creates real-time 2D and 3D maps of the patient’s heart. It also offers advanced visualization and navigation capabilities, helping users track imaging and ablation catheters during treatment. In addition, users are able mark locations as they go to confirm they achieve the necessary alignment.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “First responders and other New Yorkers around the World Trade Center that day have reported conditions including respiratory issues, mental health impacts and dementia. Toxins were present in the air soon after the attacks even though people were assured it was safe, according to a trove of records released this week by New York City officials.
    • “Twenty-five years later, attention is increasingly falling on cancer. 
    • “The number of 9/11 survivors who are receiving aid for cancer has roughly tripled over the last five years, according to a Washington Post analysis of reports from the World Trade Center Health Program, which funds health care for first responders and 9/11 survivors in New York. In June 2021, 8,870 survivors received aid for cancer treatment, jumping to 27,300 survivors in 2026 — numbers that sharply outpaced cancer claims among first responders.
    • “Of the roughly 54,000 survivors enrolled in the health program as of June, about half are receiving aid for cancer. Five years ago, that share was 35 percent.” * * *
    • “A recent New York University study of a smaller cohort of 9/11 survivors receiving medical aid as of 2024 reported a similar increase in cancer cases; it found that cases had increased around 2.5-fold between 2019-2024.
    • “This is something that we are worried about,” said Alan Arslan, an associate professor of population health at NYU and one of the authors of the study. “We’re seeing more and more patients.”
  • The Wall Street Journal relates,
    • “Dr. Henry Heimlich devised a new technique more than 50 years ago to stop people from choking. Simplicity, studies, shrewd promotion by its inventor—and a demonstration on The Tonight Show Starring Johnny Carson—made the Heimlich maneuver a go-to method.
    • “Now, it is fighting for the stage.
    • “Advocates, companies and some politicians argue that the Heimlich maneuver and back blows, another established method of rescuing people from choking, aren’t always enough. On social media and in state legislatures, they are plugging portable anti-choking devices, designed to suction stuck food or other objects from a person’s airway.
    • “Texas enacted a law last year requiring school districts to stock at least one such device on each campus with at least one employee trained to use it. New York City passed one, too. At least nine other states have weighed or are weighing bills to put devices into schools or other facilities.
    • “It’s a priority,” said New Jersey state Sen. Kristin Corrado, who co-sponsored one bill. “If we have the opportunity to save a life, we have to use all means available.” 
    • “The main U.S. maker—a company called LifeVac—has donated more than 10,000 devices to schools across the country.” * * *
    • “But medical guidelines and many researchers say there isn’t enough evidence to recommend anti-choking devices. State health departments, emergency responders and teachers unions have pushed back against proposals to require them in schools because medical guidelines haven’t endorsed them. New York City said it wouldn’t implement its law unless the devices are recommended in medical guidelines.”
  • Beckers Behavioral Health tells us,
    • “The synthetic opioid cychlorphine has been linked to at least 55 deaths nationally from 2025 to 2026, with prevalence highest in Ohio, Tennessee and Texas, MedPage Today reported Sept. 8.
    • “The Office of National Drug Control Policy said in an April drug threat notice that cychlorphine may be “up to 10 times more potent than fentanyl” and an overdose may require multiple doses of naloxone.
    • “In Tennessee, the Knox County Regional Forensic Center reported 41 overdose deaths between July 2025 and February 2026. The center tracked as many as 63 cychlorphine-associated deaths through June 30, and cychlorphine was found to be the cause in 58 of those cases.
    • “Cychlorphine has been found mainly in powders and tablets as well as counterfeit pills. Shravani Durbhakula, MD, MPH, of Vanderbilt University School of Medicine in Nashville, Tennessee, said snorting and inhaling are common, though oral exposure and injection are also possible.”
  • Cardiovascular Business informs us,
    • “A majority of transcatheter aortic valve replacement (TAVR) present with a history of heart failure (HF). According to new data published in the Journal of Cardiovascular Medicine, however, many of those patients are not being given the HF medications they need after undergoing TAVR.
    • “Cardiovascular morbidity and mortality remain high after TAVR,” wrote first author Elena Surkova, MD, MSc, PhD, a senior medical director at AstraZeneca and consultant cardiologist with Royal Brompton and Harefield Hospitals, and colleagues. “There is a lack of detailed data on the prevalence of HF in patients undergoing TAVR, medication prescription rates, including the main pillars of HF standard of care, and predictors of HF worsening following the procedure.”
  • The American Medical Association lets us know what doctors want patients to know about West Nile virus
    • “Most West Nile virus infections cause no symptoms, but some can lead to severe illness. Mosquito-bite prevention remains the best defense.”
  • MedPage Today adds,
    • “A gender gap historically seen in the suicide rates of 10- to 14-year-olds in the U.S. has tightened.
    • “In 2017, the suicide rate of boys was twice that of girls, but by 2024, it was only 4% higher.
    • “The author noted that the nearly equal suicide rates for 10- to 14-year-old boys and girls in the current study marked the “first time this has happened in the available records.”
  • Health Day notes,
    • “Autism spectrum disorder (ASD) diagnoses increased disproportionately among females after 2020, across age groups, while remaining stable or declining among males, according to a study published online July 22 in JAMA Network Open.
    • “Erick Messias, M.D., Ph.D., from St. Louis University, and colleagues evaluated age- and sex-specific incidence trends of ASD from 2016 to 2024 to quantify the temporal patterns before and after the COVID-19 pandemic. The analysis included electronic health record data from 171,134 individuals who had at least one clinical encounter annually at a large health care system.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of a preclinical study by researchers at the University of East Anglia suggest that an experimental anticancer drug could stop osteoporosis and help women prevent weight gain after the menopause. Their study in mice found that the small molecule drug CADD522 not only protected against osteoporosis but could also reduce body fat and reverse some of the metabolic changes linked to menopause. Currently in development for cancer therapy, CADD522 is a small molecule inhibitor of the transcription factor RUNX2, which is helps to drive the growth and spread of several cancers.
    • “Research lead Darrell Green, PhD, at UEA’s Norwich Medical School, said, “We have uncovered an entirely new way of tackling the disease. We found that a drug originally developed to stop cancer could help millions of women facing the twin challenge of fragile bones and midlife weight gain. We hope our work could lead to a new generation of osteoporosis treatments that tackle bone loss while also addressing some of the wider metabolic consequences of menopause.”
    • “Green is senior and co-corresponding author of the team’s report in npj Drug Discovery, titled “RUNX2 inhibitor CADD522 improves bone microarchitecture and lipid metabolism in post-menopausal bone loss.” In their paper the team concluded that their collective studies “… identify RUNX2 inhibition as a therapeutic strategy that simultaneously improves skeletal integrity and metabolic homeostasis, supporting further development of CADD522 for osteoporosis and other RUNX2-driven diseases.”

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

  • The International Foundation of Employee Benefit Plans reports,
    • “Medical stop-loss premiums in 2026 show an increase from 13.6% on a $100,000 deductible to 15.9% on a $750,000 deductible, as reported by the 2026 Aegis Risk Medical Stop-Loss Premium Survey, cosponsored by the International Society of Certified Employee Benefit Specialists. Notably, this increase is approximately 5% to 5.5% higher than increases seen for the previous 2025 renewals. This impact was not surprising, as many underwriters reported increased severity and frequency in stop loss-claims in late 2024 and a resulting erosion in claims-to-premium loss ratios thereafter and throughout 2025. The survey captured necessary correction to 2026 premiums. The measured increases, rising alongside the size of deductible, reflect leveraged medical trend, as the underlying growth in expense of a catastrophic medical claimant is fully borne by an unchanged deductible.
    • “Survey response uniquely captures final, negotiated premium and reflects any pricing improvement from renewal marketings and concessions across all deductibles. In comparison, several large direct underwriters reported an average 2026 increase in the low 20% range on their own book-of-business. However, those are weighted by in-force policies unable to locate lower cost alternatives. The comparatively lower increases observed in this survey reflect the 2026 renewal rate opportunity found in the market. Looking ahead, an ongoing return to underwriter discipline and need to restore insurer loss ratios to a more profitable position does not indicate any easing on the 2027 renewal cycle.”
  • Fierce Pharma relates,
    • “Shifts in drug pricing and market access policies around the world have caused an “earthquake” that will reverberate for years to come, a survey of industry leaders found.
    • “Healthcare consultancy Numerof & Associates generated the insights in a survey of 175 executives from 67 pharmaceutical companies. The qualitative survey revealed the belief that the current era of policy change is unlike anything that the industry has experienced before. After going through a period of fast change, the industry is braced for more upheaval in the coming years. 
    • “While there has always been change throughout the industry, the past 24 to 36 months have felt more exponentially transformative than anything I have seen over the last 30 years,” an executive said. “What we may experience over the next five years could exceed the cumulative level of change we saw over the previous several decades.”
    • “Another executive characterized the policy environment as an “earthquake” that is “not going to settle down soon,” while a third person predicted that the need for politicians to try to address the cost of healthcare will ensure ongoing change. 
    • “The executives were talking after a succession of policy changes in key markets. Medicare gained the authority to directly negotiate prices for some drugs, and the most-favored-nation (MFN) policy tied U.S. prices to overseas markets.” 
  • Healthcare Dive tells us,
    • “UnitedHealthcare is still drilling down on actions it can take to make its Medicare Advantage plans more profitable next year, even as the insurer is expected to exit more underperforming geographies. But the company could be poised for growth in the markets where it remains, according to new comments from a top executive.
    • “We think we’re going to be very competitive in terms of our pricing next year,” CFO Wayne DeVeydt said during Wells Fargo’s annual healthcare conference Wednesday morning. “We think our benefits will be competitive … We still have a few markets where we’re right-sizing some of the products, but I think we’ll be well-positioned for 2027.”
    • “DeVeydt’s comments come as market watchers try to get a sense of how 2027 open enrollment will pan out, following an especially turbulent sign-up period for 2026 after insurers culled their plans in a bid to resuscitate flagging margins.”
  • Modern Healthcare adds,
    • “UnitedHealth Group and CVS Health are looking into acquisitions, executives said at a Wells Fargo conference.
    • “UnitedHealth Group identified value-based care companies and companies that would fit into its Optum Insight division as targets.
    • “CVS Health will seek “bolt-on” acquisitions and resume share buybacks next year.”
  • Beckers Payer Issues informs us,
    • “Anthem is now covering three surgical meshes for breast reconstruction, according to a clinical guideline published Aug. 27.
    • “DuraSorb Monofilament Mesh, GalaFLEX and TIGR Matrix Surgical Mesh “are considered medically necessary when used for breast reconstruction surgery,” the guidance said.
    • “We regularly review our medical coverage policies to ensure they’re aligned with credible medical evidence and the latest treatment standards and expert recommendations,” an Elevance Health spokesperson told Becker’s.” * * *
    • “ABC affiliate WFTS-TV in Tampa, Fla., has been reporting on breast cancer insurance denials, including for mesh, in recent years. It reported how Cigna updated its policy to cover mesh for breast reconstruction in 2025.
    • “Despite calls for insurer coverage, mesh for breast reconstruction has not secured FDA approval.”
  • and
    • “UnitedHealth Group’s Optum has sold interest in some of Optum’s Florida WellMed clinics to private equity company TPG, Bloomberg originally reported Sept. 9. UnitedHealth Chief Financial Officer Wayne DeVeydt told Bloomberg that the healthcare company was looking for a partner “that could actually work with us locally,” and UnitedHealth “didn’t need the dollars.” 
    • “We entered a strategic partnership designed to strengthen operating performance through dedicated support for clinic operations, targeted investments in technology and tools, and enhanced operating capabilities,” an Optum spokesperson told Becker’s Sept. 9. “The transitioning clinics will remain part of Optum’s network and continue providing high-quality care to patients. We remain committed to serving Florida patients through our integrated, value-based care model.”
  • Beckers Behavioral Health lets us know,
    • “Santa Fe, N.M.-based Quel Health launched a telehealth platform focused on using GLP-1 receptor agonists in addiction care. 
    • “The platform is available in 41 states and the District of Columbia, with national coverage planned by year-end, according to a Sept. 8 news release from the company. Quel also named Wernersville, Pa.-based Caron Treatment Centers a founding strategic partner.” * * *
    • “The approach follows work at Caron’s Pennsylvania and Florida campuses, where Steven Klein, MD, PhD, co-founder and chief medical officer of Quel Health, and his team evaluate GLP-1 receptor agonists in patients whose primary diagnosis was substance use disorder rather than obesity or diabetes.” 
       
  • Per Fierce Healthcare,
    • “Employers Health and Judi Health are teaming up to launch StarkRx, a new cost-plus benefit offering designed to drive transparency for employers.
    • “The approach unites the expertise of Employers Health as a group purchasing organization for pharmacy benefits that’s backed by employers with the technology available through Judi. The goal, the partners said, is to ensure that self-funded employers have greater access to transparency data that they can use to identify and manage cost drivers.
    • “Employers are expected to see another year of significant healthcare cost increases in 2027, with pharmaceuticals serving as a major factor behind the trend. A recent analysis from Marsh (formerly Mercer) estimated that costs could increase by 8.2% next year.
    • “Advanced, high-cost therapies and GLP-1 medications were both cited as key cost drivers in that analysis.”
  • and
    • “H1 has acquired Defacto Health, a healthcare data company focused on provider network intelligence, in a move to expand its offerings for health plans and strengthen its healthcare data assets.
    • “H1 is an AI-powered platform that brings healthcare data, domain expertise and an artificial intelligence platform to life science companies. The company built an AI-powered platform that helps identify and engage the right doctors for critical workflows across pharma, health plan, health system and technology companies. 
    • “Defacto Health is an AI-driven provider intelligence platform that aggregates and analyzes health insurance payer networks, provider directories and medical demographics data. The company maintains data on payer networks, healthcare providers and the insurance plans providers accept, helping health plans assess directory accuracy, isolate error clusters and benchmark their networks.”
  • Beckers Hospital Review reports,
    • “The American Medical Association released its 2027 Current Procedural Terminology (CPT) code set Sept. 9, an update that adds 299 codes and continues to build out billing for clinical AI.
    • “The set takes effect Jan. 1 and carries 453 total editorial changes: 299 new codes, 74 revisions and 80 deletions, the AMA said.
    • “Ten of the new codes describe AI-related services, raising the total number of AI-related CPT codes to 43. The AMA also updated Appendix S, its taxonomy that sorts medical AI by how much of the work the machine does — assistive, augmentative or autonomous — and guides how new tools get coded.
    • “As new technologies and clinical approaches emerge, the nation’s health system needs a reliable way to describe the care physicians provide,” said AMA President Willie Underwood III, MD. Dr. Underwood said a physician-led coding system gives that work “unmatched scale, expertise and legitimacy.”
    • “The set’s key clinical change, released in August, is a maternity coding overhaul that retires the decades-old global maternity bundle in favor of separate reporting across antepartum, labor, delivery and postpartum care.”
  • MedTech Dive offers “5 takeaways from Oura’s IPO filing.”
    • The wearables firm’s sales are growing, and it is adding more paid members, but questions loom about whether the company will need to approach future features as a medical device.
  • and tells us,
    • “Labcorp said Tuesday it has acquired MLM Medical Labs to add global central laboratory and biomarker capabilities for clinical trials.
    • “MLM is a global central and specialty laboratory provider with operations in the U.S., Germany and South Africa. 
    • “The deal makes Labcorp the only central laboratory provider with a wholly owned lab network across four continents, the acquiring company said. Neither party disclosed the financial terms of the deal.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC

  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, September 15, 2026, at 10:00 AM ET to consider Gerard Klomp to be Deputy Secretary of Health and Human Services (HHS); James Gadwood to be Chief Counsel for the Internal Revenue Service (IRS) and an Assistant General Counsel in the Department of the Treasury; Ge Bai to be an Assistant Secretary of HHS; and Andrew A. De Mello to be a Judge of the United States Tax Court.” * * *
    • “Opening statements and a live video of the hearing will be available on www.finance.senate.gov.”
  • Beckers Hospital Review reports,
    • “HHS has selected four senior leaders for the FDA, including directors for the agency’s drug, biologics and tobacco centers and its first deputy commissioner focused on technology and artificial intelligence.
    • “Jared Seehafer was selected as the FDA’s first deputy commissioner for technology and artificial intelligence, according to a Sept. 8 HHS news release. He will serve as the agency’s senior leader for technology, software and AI and lead FDA-wide strategy and priorities in those areas.
    • “Michael Davis, MD, PhD, was selected as director of the Center for Drug Evaluation and Research after serving as acting director since May, when his predecessor was fired days after the agency’s commissioner stepped down. He will lead the center responsible for helping ensure safe, effective and high-quality drugs are available to the public.
    • “Karim Mikhail was selected as director of the Center for Biologics Evaluation and Research after serving as acting director, a post that has seen frequent turnover over the past year and a half. The center regulates biological products, including vaccines, blood and blood products and cellular and gene therapies.
    • “Bret Koplow, PhD, was selected as director of the Center for Tobacco Products after serving as acting director. He has served at the FDA since 2011.”
  • Behavioral Health Business informs us,
    • “The Trump administration today released guidelines on renewed enforcement efforts under the Mental Health Parity and Addiction Equity Act (MHPAEA), after halting enforcement of the law in 2025.  
    • “The latest guidelines are not the administration’s revised parity law, but rather a framework for enforcement action and identifying red flags during the interim. 
    • “A Sept. 8 bulletin from the Assistant Secretary for the Department of Labor’s Employee Benefits Security Administration (EBSA), Daniel Aronowitz, describes the agency’s intent to more substantially enforce the parity law’s nonquantitative treatment limitation (NQTL) requirements, which resulted from collective industry feedback.” * * *
    • “The renewed enforcement focus will fall into three buckets, identified as areas of enforcement need in a 2025 report from the agency to Congress: treatment limitations and exclusions; standards for medical necessity and review and standards for determining network adequacy, admissions and provider reimbursement methodologies.” 
  • Beckers Hospital Review tells us,
    • “ACA insurers requested a median rate increase of 15% for 2027, according to a Peterson-KFF Health System Tracker analysis. However, [as explained in the article,] some states are pushing back — while others are abiding by those requests — as they finalize increases.”

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

  • FedScoop reports,
    • “The Office of Personnel Management is looking to prevent data on the federal government’s public job board, USAJobs, from making its way onto misleading websites. 
    • “Last week, OPM updated terms of service for users of its USAJobs application programming interface (API) to include prohibitions on several actions related to the sale or redistribution of data from the website “to third parties as a standalone product or feed.” 
    • “Data provided to you through the API is for the explicit use of the requesting company or individual identified on the USAJOBS Program Office API Registration Form. No other use of the data provided is permitted without prior approval, in writing, from OPM USAJOBS,” said an emailed notice sent to API users, including FedScoop. 
    • ‘While the reason for that change wasn’t initially clear, an OPM spokesperson told FedScoop via email Friday that the policy change is aimed at preventing “unauthorized services that appear to be USAJOBS or allow users to apply for federal jobs outside USAJOBS.” 
  • Federal News Network interviews Tammy Flanagan about questions that federal and postal employees may have about their FEHB and PSHB coverage as they turn 65 years old.

From the judicial front,

  • Beckers Payer Issues reports,
    • “Humana lodged a federal complaint Sept. 3 against Bayer AG and its acquired company, Monsanto, the business behind the weedkiller Roundup, seeking recoveries to address payments for Medicare Advantage members’ non-Hodgkin lymphoma-related care.
    • “Roundup’s active ingredient, glyphosate, has previously been linked to cancer risks. The lawsuit, filed in the U.S. District Court for the District of New Jersey, follows Monsanto’s proposed $7.25 billion settlement in February to resolve Roundup claims alleging non-Hodgkin lymphoma injuries. The settlement would act as a long-term compensation program, addressing current and future claims. Monsanto announced other settlement agreements in 2020, as well.
    • “However, Humana argues the February proposal does not confirm reimbursement for Medicare Advantage organizations that have already paid for relevant care. While the settlement acknowledges government payers, it establishes an “other insurers” category, including contracted payers. The complaint said this settlement lacks a “functional” lien-resolution program.”

From the fraud, waste, and abuse front,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “As part of the White House Anti-Fraud Task Force’s ongoing efforts to crush fraud in the healthcare system and protect taxpayer dollars, the Centers for Medicare & Medicaid Services (CMS) has identified and is barring 11 medical supply companies with more than $3.4 billion in suspected fraudulent billing practices in 2025 and 2026 from receiving future Medicare Advantage (MA) Part C and Part D payments. These 11 durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers, (1) had submitted no claims prior to 2025; (2) used improper billing practices for their claims; (3) had billed for medical equipment to beneficiaries already deceased; and (4) supplied equipment to beneficiaries who never requested or received it. Four of the suppliers had already been revoked from Original Medicare and began billing Medicare Advantage plans instead.” 

From the public health and medical / Rx research front,

  • Beckers Hospital Review reports,
    • “Albuquerque, N.M.-based Presbyterian Hospital said it found Legionella pneumophila in limited areas of the water system, including two rooms, Fox affiliate KRQE reported Sept. 7.
    • “The hospital implemented testing for the bacteria after a patient who recently received care at the hospital tested positive for Legionnaires’ disease. However, officials with the New Mexico Department of Health told CBS affiliate KOAT there is no definitive evidence showing the patient contracted the bacteria from Presbyterian. No additional cases have been identified and there is no known exposure to other patients or staff.
    • “The hospital received the environmental testing results Sept. 3 and immediately implemented safety precautions in affected areas.”
  • MedPage Today relates,
    • “Nicotine was long thought to fuel the inverse relationship between smoking and Parkinson’s disease.
    • “In this study, nonsmokers with high carbon monoxide (CO) levels had less Parkinson’s risk, suggesting CO may underlie smoking’s neuroprotective effects.
    • “The study followed more than 500,000 people for 12 years, measuring exhaled CO at baseline.”
  • and
    • “In a study of perimenopausal and recently postmenopausal women with vasomotor symptoms, initiation of menopausal hormone therapy (MHT) was associated with a 22% reduction in cardiovascular events.
    • “Notably, benefits were observed in those who initiated hormone therapy within 10 years of menopause onset and in Black women.
    • “The authors cautioned that given the lack of consistent cardiovascular benefit and the overall risk-benefit balance, the findings shouldn’t be used to support the use of MHT for cardiovascular prevention.”
  • Healio adds,
    • “Menopause remains inconsistently documented in electronic health records, according to a new systematic review published in Menopause.
    • “We expected to find some variation in how menopause was documented, but the extent of the inconsistency was striking,” Robin R. Austin, PhD, DNP, DC, MSN, RN, NI-BC, FAMIA, FAAN, an associate professor at the University of Minnesota School of Nursing, told Healio. “Menopause status and symptoms were often identified indirectly or incompletely, making it difficult to understand where a woman is in the menopause transition.”
  • Reuters tells us,
    • “Prescriptions for GLP-1 weight-loss drugs among children under 12 in the U.S. have risen more than 300-fold since 2019 as doctors seek new, effective ​treatments for younger patients with obesity, according to a study published on ‌Friday.
    • “The study, which included more than 3.5 million children aged between eight and 11 years with obesity but not diabetes, found that prescriptions for GLP-1 weight-loss drugs rose from 0.03% in ​2019 to 9.3% as of June.” * * *
    • “Although the drugs are not approved ​for use in children under 12 years, clinical guidelines allow the ⁠medications to be used for obesity in children as young as eight years ​old in certain cases.
    • “94% of the children prescribed GLP-1s had severe obesity, and ​about 65% had at least one related condition, such as high cholesterol, high blood pressure, and sleep apnea.” * * *
    • “While the absolute numbers of ​children under 12 receiving GLP-1 treatment is still low, the study shows that GLP-1 use ‌is ⁠accelerating rapidly, said lead investigator and obesity medicine specialist Dr. Babak Orandi of NYU Langone Health.”
  • Fierce Pharma adds,
    • Novo Nordisk has reported a phase 3 weight-management win for Wegovy in children, with two out of five kids no longer classified as having obesity after receiving the GLP-1 drug for 68 weeks.
    • Wegovy, the brand name for semaglutide in indications including obesity, is FDA approved for reducing body weight in people aged 12 years and older. Yet Wegovy and other GLP-1 drugs are increasingly used off-label in younger children, with a recent study finding that prescriptions in kids aged 8 to 11 jumped from 0.03% in 2019 to 9.3% in 2026.
    • Novo’s Step Young phase 3 trial suggests the younger children may benefit from Wegovy. Participants received weekly Wegovy injections of either 1.7 mg or 2.4 mg, based on their weight at the start of the trial, or placebo. All participants were assigned a reduced-calorie diet and increased physical activity.
  • STAT News informs us,
    • “In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday. 
    • “Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that “tozo,” as the injectable drug is dubbed, could reap billions in annual sales if approved, both in COPD — which, as the third-leading cause of death globally, remains greatly underserved — and in other conditions including asthma.” 
  • BioPharma Dive adds,
    • “Roivant said Tuesday a would-be treatment for a particular kind of high blood pressure associated with lung inflammation met all of its main and secondary objectives in a Phase 2 trial. Roivant’s medication, “mosliciguat,” reduced by 56% a measure of how difficult it is for blood to flow through the lungs of people with pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Roivant claimed that result was the “highest ever reported” in a randomized pulmonary hypertension trial and has already begun a Phase 3 study. The “exceptional” results, along with plans to develop mosliciguat in other conditions, could yield a drug with more than $10 billion in yearly sales, wrote Leerink Partners analyst David Risinger. Roivant shares surged 20%.”
  • and
    • “A new kind of cancer cell therapy from Bristol Myers Squibb has come through in a mid-stage trial, the company announced Tuesday. Dubbed arlocabtagene autoleucel or arlo-cel, the therapy is a CAR-T treatment directed at GPRC5D, a cell surface protein that’s overexpressed on diseased cells in multiple myeloma. Bristol Myers didn’t provide specific details. But it said arlo-cel demonstrated a “statistically significant and clinically meaningful” response rate in people whose multiple myeloma had progressed following at least four treatment lines — among them drugs aimed at BCMA, a more established multiple myeloma target.”
  • Fierce Pharma notes,
    • “In further validation of the DLL3 target pioneered by Amgen’s Imdelltra, the T-cell engager has delivered an overall survival win in first-line small cell lung cancer (SCLC).
    • “Imdelltra, used together with AstraZeneca’s Imfinzi, led to a “statistically significant and clinically meaningful” improvement in overall survival (OS) compared with Imfinzi alone as a first-line maintenance treatment for extensive stage SCLC, Amgen announced Tuesday.
    • “The Imdelltra regimen also showed superior progression-free survival and objective response rate, with safety consistent with the drugs’ known profiles, the company added.”
  • Genetic Engineering and BioTechnology News lets us know,
    • “Although the highly contagious bacterium Clostridioides difficile (C. diff) causes severe disease in adults, it has been reported to not cause symptoms in infants. Based on that, the assumption has been that infant colonization was not a serious health issue. That said, the consequences of early-life colonization on host development remain unknown. Now, in a new study, researchers at Children’s Hospital of Philadelphia (CHOP) are challenging that long-held assumption, with new findings suggesting that the bacterium can reshape the developing infant gut and may have long-term consequences.
    • “This work was published in Science in the paper, “Early-life colonization with Clostridioides difficile remodels the developing gut.”
  • The New York Times points out,
    • “Last year, a clinical trial conducted by Insilico Medicine, a company that aims to accelerate drug discovery using artificial intelligence, indicated that one of its drug candidates could help treat patients suffering from a chronic lung disease.
    • “Now, the company says that data from the same clinical trial shows a more intriguing possibility: that the drug could also slow the aging process.
    • “The molecular structure of the drug, called rentosertib, was generated with the assistance of A.I. Results of the new study, published Monday in the journal Nature Biotechnology, show that the drug reduced the biological markers of age as measured by six “aging clocks,” a different kind of A.I. technology designed to predict a person’s morbidity and mortality.
    • ‘This elaborate clinical trial is a milestone in the widespread effort to improve health care using the same A.I. techniques that underpin popular chatbots like ChatGPT and image generators like Midjourney. Insilico is just one of many start-ups, tech giants and academic labs working to accelerate drug discovery and honeother medical tasks with help from these methods.”
  • and
    • “It is one of biology’s most ingenious rhythms: Every baby is born young. No matter how much wear and tear their parents’ DNA accumulated over their lifetimes, reproduction erases the molecular scars, handing a clean slate to the next generation.
    • “Now, a new frontier in biotechnology aims to harness this natural mechanism to do something once thought impossible: scrub away the biological detritus of our own past. By mimicking Mother Nature’s magic eraser, geneticists are working to open a new avenue for treating or preventing disease later in life — not by editing genes themselves, but by altering when, where and how genes are expressed.
    • “All of this is possible thanks to the epigenome, a network of chemical tags throughout the body that latch on to DNA and tell each cell type how to behave. If a person’s DNA is a string of notes in a musical score, the epigenome is the collection of the conductor’s pencil markings left on the page — accumulated through experience over time, indicating which notes to play louder or softer or to skip entirely.”

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

  • Beckers Payer Issues reports,
    • “Growth in healthcare spending, not insurer profit margins, drove the vast majority of commercial premium increases over more than a decade, according to a study published Sept. 4 in JAMA Health Forum.
    • “Researchers at Yale University and the University of Wisconsin-Madison analyzed CMS data from 2011 to 2024 covering the large group, small group and individual markets, which included information on premiums, health spending and insurer markups for each state and year. The data did not include self-insured employers, which cover roughly half the U.S. population.”
  • Fierce Healthcare relates,
    • “After a failed round of in vitro fertilization this year, Anne Hug’s fertility doctor said she had a single polyp in her uterus that should be removed to improve the chance of pregnancy. Hug, a professor of radiology, learned that the American College of Obstetricians and Gynecologists says the procedure can be done in a doctor’s office with local numbing.
    • “Her doctor referred her to a physician at the same hospital, which is part of a large Ohio health system. That doctor’s plan was to do the procedure in a hospital operating room, with anesthesia administered by an anesthesiologist.
    • “Hug balked at the $18,000 estimate.
    • “The estimate for the in-office procedure was around $3,000. The bill when she was forced at the last minute to switch to the surgery center was around $6,000. She now wonders, “How is it legal for these hospitals to force patients to have procedures done in a hospital when professional organizations recommend differently?”
    • “Hug’s experience is a classic example of the predicted outcome of “vertical integration” in the healthcare system, when one company owns or controls multiple parts of a supply chain and can therefore direct patients to more expensive treatment options.”
  • Beckers ASC Review tells us,
    • “Twenty-seven states [listed in the article] have opted out of the federal requirement that a physician supervise CRNAs administering anesthesia, according to the American Association of Nurse Anesthesiology’s most recent fact sheet, updated in July 2026.
    • “Vermont and Ohio became the 26th and 27th states to opt out, making the move in July 2026. The full list stretches back more than two decades, and for ASC leaders dealing with anesthesia staffing costs, where a state falls on that list is directly relevant to how much flexibility they have to restructure anesthesia coverage.” * * *
    • “In opt-out states — provided state law and facility policy also allow it — ASCs have more room to build CRNA-based staffing model models. Seattle-based Proliance Surgeons moved to a CRNA-only staffing model in 2025 after the anesthesiology group it was partnered with decided not to renew its contract. After switching the new model, the organization reported no patient care delays and no cases redirected to hospitals over provider-availability concerns.
    • ‘That’s just one case study, but as more states move away from the federal supervision requirement, the staffing-model conversation for ASCs is likely to keep shifting from “how much do we pay for anesthesiologist coverage” to “do we need anesthesiologist coverage for this case mix at all.”
  • The American Hospital Association News notes,
    • “A report on obstetric services in hospitals by the University of Minnesota Rural Health Research Center found that between 2010 and 2024, 718 hospitals nationwide lost obstetric services due to obstetric unit or hospital closure. The report found that 9% of those losses happened from 2023-2024. Between 2010-2024, 14% of hospitals (16% of rural hospitals, 13% of urban hospitals) lost obstetric services, while 35% (42% rural, 30% urban) never had obstetric services during that period. By 2024, 57.5% of rural hospitals and 43.6% of urban hospitals across the U.S. were without obstetric services.” 
  • Healthcare IT News explains how “telemedicine becomes more deeply embedded into hospital workflows.”
    • “Health systems are using virtual nursing, tele-ICU, remote specialty care and EHR-integrated teams to extend scarce expertise, support bedside clinicians and redesign care delivery.”
  • Beckers Physician Leadership discusses the “uneven collapse of private medical practice.”
    • “While the decline of independent practice has persisted as a general trend across medicine, the consolidation of physician practices has played out differently across specialties. 
    • “A 2025 specialty-level breakdown of independent practice published by the American Medical Association found private-practice rates ranging from 70.4% in ophthalmology down to 30.7% in gastroenterology, a nearly 40-percentage-point gap between the most and least independent of the five specialties driving the bulk of physician practice mergers and acquisitions activity.”
  • Fierce Healthcare informs us,
    • “Oura, the smart ring maker and health tracking company, filed to go public on Thursday [September 10] to fuel its next phase of growth as it aims to build an artificial intelligence-powered health platform.
    • “The company has not specified the number of shares to be offered or the price range for the proposed offering. Oura intends to list on the Nasdaq under the ticker symbol “OURA.”
    • “Founded in Finland in 2013, Oura’s smart rings continuously track more than 50 health metrics, including heart rate, sleep, daily movement and activity, stress, fertility windows and metabolic health.”
  • and
    • “Five Kansas health systems have launched a regional collaboration, called Astra Health, to pool resources and coordinate services while retaining their independence. 
    • “The new shared services organization was announced Tuesday and will include LMH Health, The University of Kansas Health System, Amberwell Health, Newman Regional Health and Salina Regional Health Center. Together, the organizations see more than half a million patients annually and extend into every county in the state. 
    • “The partnership will help participating hospitals improve quality, share best practices, enhance performance measurement, and strengthen care delivery in the communities they serve,” Shelly Kortkamp, M.D., president and CEO of LMH Health, said in an announcement.”
  • and
    • “Health tech startup Forus banked $150 million in series C funding as it aims to expand its artificial intelligence-powered network to more medical specialties and care settings.
    • “The fresh funding comes just four months after the company announced it raised $160 million in a series B round. The latest funding round boosts Forus’ valuation to $3 billion, tripling from its series B round in May, according to the company. Forus has raised more than $300 million to date.
    • “Bain Capital Ventures, an investor in Forus since its seed round, led the latest round, with every existing institutional investor reinvesting, including Thrive Capital, General Catalyst, Accel, Redpoint, BoxGroup, Pear VC, Vast Ventures and SV Angel.”
  • Per BioPharma Dive,
    • “BrainChild Bio, a cell therapy developer making CAR-T treatments for children with rare brain cancers, has banked $116 million in a round of venture financing, the company announced Tuesday.
    • “CAR-T therapies are powerful treatments engineered from immune cells. A handful have been approved to treat certain blood cancers, and many companies are studying their potential on other tumors and even autoimmune diseases.
    • “But according to BrainChild founder and Chief Scientific Officer Michael Jensen, few companies have tried to test CAR-T treatments against brain cancer. “The prejudice is that the brain would be intolerant to having cells directly administered,” he said. 
    • “BrainChild is different. Spun out of research at Seattle Children’s Hospital three years ago, the company is working on a pair of brain cancer cell therapies designed specifically for children.”
  • Per Fierce Pharma,
    • “Spying a “golden decade” beyond the branded drug industry’s looming patent cliff, Sandoz is making big bets on its biosimilar capabilities in the coming years. 
    • “Under the company’s so-called Bio100 plan, Sandoz is setting the ambitious goal to establish a portfolio of more than 100 biosimilars by 2040, up substantially from the 13 it currently markets. Meanwhile, the company also aims to expand the overall biosimilar loss of exclusivity (LOE)-value it holds from some 50% today to around 80% from 2035 onwards.
    • “Part and parcel to that, Sandoz hopes to double its net sales from 2025 through the middle of the next decade, according to a Sept. 8 release outlining the strategy. For all of last year, the Swiss drugmaker reported 5% net sales growth at constant currencies to $11.1 billion.” 
  • Tech Target offers “6 use cases for improving employee retention using predictive analytics.”
    • Predictive analytics can identify employees who are good candidates for promotion. Learn other use cases for improving employee retention using predictive analytics.

Friday report

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

Simplicity is a virtue.

From Washington, DC

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

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

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front

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

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

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

Monday report

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

Simplicity is a virtue.

From Washington, DC

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

From the U.S. Office of Personnel Management front

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Monday report

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

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    •  “In the chapel of a homeless shelter, health secretary Robert F. Kennedy Jr. stood behind a lectern with a “Cancel Corruption” sign and lambasted local officials for mishandling the city’s homelessness and substance use crisis.
    • “Just 24 hours earlier, Kennedy was in the Oval Office, standing alongside President Trump, as the president signed an executive order calling for major changes to childhood vaccinations.
    • “The change in tone — from day to day and coast to coast — shows how Kennedy’s sprawling political messages tied to his Make America Healthy Again movement vary depending on the audience he is in front of.”
    • “In Los Angeles, Kennedy kept the message fairly local, speaking before conservative city officials and a mission group of roughly a hundred teenagers and praising the shelter he was visiting. But from Washington, Kennedy has become a spokesman of the administration’s more far-reaching policies: fewer vaccines for kids and more regulation of food additives, both announced on Monday from the nation’s capital, before he headed West.” 
  • Per an HHS news release,
    • The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today announced $96.7 million in grants and cooperative agreements to strengthen behavioral health services and supports across the country. The awards provide funding for a range of behavioral health services and initiatives, including services for people with serious mental illness who are homeless, suicide prevention and early intervention, substance use disorder treatment, training and technical assistance, peer support, and disaster-related emotional support.
    • “Every American deserves the opportunity to recover and live with dignity,” said HHS Secretary Robert F. Kennedy, Jr. “These investments will expand access to treatment, strengthen behavioral health services, and help more people move from crisis to recovery. That is how we restore health, rebuild lives, and strengthen our communities.”
  • Meritalk interviews the U.S. Office of Personnel Management’s Chief Information Officer Adam Starr.
    • “As CIO roles become more strategic, OPM CIO Adam Starr says agencies need to give technologists room to move faster, embed AI and security into the business, and create a culture that rewards measured risk.”
  • Federal News Network relates,
    • “The Defense Logistics Agency’s five-year IT modernization journey reached an important milestone earlier this summer.
    • “DLA moved its catalog system off a 35-year-old COBOL-based system and onto a new modern platform.
    • “Adarryl Roberts, DLA’s chief information officer, said the agency will now have a system that will allow it to process data and requests much faster.”
  • FEHBlog observation — This is another example of IT modernization that causes the FEHBlog to wonder why OPM cannot convert its outdated CLER system to the modern HIPAA 820 electronic transaction that allows carriers to reconcile premiums at the individual enrollee level.
  • Fierce Healthcare tells us,
    • “Amid instability in the Affordable Care Act marketplaces, proponents of ICHRA have suggested that these models could help support risk pools. A new survey from the HRA Council adds to the body of evidence on the matter. 
    • “The council, a nonpartisan organization that pushes for expanded coverage options, released its latest look at trends around individual coverage reimbursement arrangements, or ICHRA, and found that a growing number of larger employers are considering it as an option.
    • “The larger employee base from these firms could bring more younger, healthier individuals into the market, adding greater stability to the risk pools that would be felt on the exchanges, according to the report.”

From the Food and Drug Administration front,

  • The Hill reports,
    • “More cases have been linked to outbreaks of cyclospora that do not have an identified source, according to the Food and Drug Administration. The outbreak linked to iceberg lettuce, meanwhile, has expanded to two additional states. 
    • “There have been nearly 14,000 cases of domestically acquired cyclospora confirmed in the U.S. since May this year, the Centers for Disease Control and Prevention report. That’s well over the roughly 1,180 cases reported from May through August last year.
    • :Of this year’s cases, at least 9,480 were reported in the 17 states connected to the cyclospora outbreak traced back to iceberg lettuce, according to the FDA and the CDC. Two states, Maine and Massachusetts, were added to that tally late last week.
    • At least some of the nation’s cases are also linked to the ongoing cyclospora outbreaks that the FDA has been investigating. 
    • “There are seven active investigations into cyclospora outbreaks, the FDA’s tracking shows. Three – sickening 18, eight and two people, respectively – are listed as ended. Only the outbreak linked to iceberg lettuce has an identified source.
    • “Two outbreaks have grown, according to the FDA. One, which was first reported in early August, has grown to 11 cases. Another, from late July, has grown to 172 cases, up from 115. The FDA continues to conduct traceback in both outbreaks, as well as three other still active outbreaks.
    • “We may never know the cause of the outbreak. Because of how long it can take for people to experience symptoms, and the difficulties of sequencing cyclospora, investigations can “take a significant amount of time,” Gwen Biggerstaff, the deputy director of the CDC’s Division of Foodborne, Waterborne, and Environmental Diseases, previously explained.”
  • MedTech Dive relates,
    • “Johnson & Johnson said Monday its Monarch bronchoscopy robot for lung cancer diagnosis received Food and Drug Administration clearance for a software update that adds several new features to the platform, including artificial intelligence tools designed to make pre-procedure planning more intuitive.
    • “Other improvements broaden compatibility with commonly used imaging systems and support navigation and targeting to help physicians address anatomical changes that can occur during the procedure.
    • “The Quest 3 update is the Monarch system’s fourth major software launch in the past 18 months, according to J&J.”
  • and
    • “The Food and Drug Administration has selected Cadence, a software company that makes an artificial intelligence-assisted tool for hypertension management, as the second company for its digital health pilot. 
    • “The Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, exempts certain digital health devices from FDA premarket authorization requirements while allowing companies to collect real-world data through a related Medicare program. 
    • “Cadence, which announced the FDA’s selection last week, plans to report real-world data related to the safety, performance and patient outcomes associated with its device to help inform how clinical AI systems are built and regulated in the future.”

From the judicial front,

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

From the public health and medical / research front,

  • The Washington Post reports,
    • “More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
    • “Starting this week, that grueling regimen can be reduced to just one shot a week.
    • “Novo Nordisk announced Tuesday that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
    • More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
    • “Starting this week, that grueling regimen can be reduced to just one shot a week.
    • “The appeal of reducing 365 shots a year to 52 is obvious: greater convenience, less pain. Novo Nordisk says removing the daily requirement can create “a routine that feels more manageable.” 
    • “But there are other issues to keep in mind — most importantly, the risk of hypoglycemia, or low blood sugar, which Novo Nordisk said was a common adverse reaction in Awiqli clinical trials. Hypoglycemia can make people feel shaky, irritable, and, if the blood sugar gets very low, confused. It can be dangerous and can even cause death if it gets excessively low.
    • “Novo Nordisk announced Tuesday [August 11, 2026] that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
    • “Another factor is access: It is not yet clear which insurance plans will cover Awiqli and whether they will require patients to jump through hoops to qualify for coverage.”
  • MedPage Today relates,
    • “Using a panel of 11 genes linked to pediatric cancer predisposition syndromes, researchers found pathogenic or likely pathogenic variants in 7% of newborns who later developed a solid or brain tumor.
    • “Targeted sequencing of this panel would identify approximately 1/27,000 infants who will develop cancer by age 8 years in the setting of a genetic cancer predisposition syndrome.
    • “Researchers said it is feasible to conduct genomic newborn screening universally.” * * *
    • “[E]arly identification of these children could alter their survival outcomes, Diller and team noted.
    • “It’s become clear over the past few decades that at least 10% or more of kids who develop cancer have genetic predisposition to cancer, and a good chunk of those kids are diagnosed in the first few years of life,” Diller told MedPage Today. “It predisposes them to very-early-onset cancers. So the clinical problem is, can we do anything other than wait for them to develop their cancers?”
  • Health Day tells us,
    • “Ultra-processed foods might be linked to a higher risk of prostate cancer, a new study says.
    • “Men who ate the most ultra-processed foods had as much as a 34% higher risk of prostate cancer, compared to those who ate less, researchers reported recently in theAmerican Journal of Medicine.
    • “Among adult men in this nationally representative U.S. population, those who consumed higher amounts of UPFs had significantly higher risks of the subsequent development of prostate cancer,” said senior researcher Dr. Charles Hennekens, a professor of medicine and preventive medicine at Florida Atlantic University.
    • “These findings add to emerging evidence that UPFs have major adverse health effects and underscore the need for large-scale observational studies and randomized trials to adequately test the hypothesis,” Hennekens said in a news release.”
  • and
    • “A person’s sleep patterns could be an early sign of Alzheimer’s disease, a new study says.
    • “A greater number of micro-awakenings during sleep is linked to a greater genetic risk for Alzheimer’s, researchers reported recently in the journal Sleep.
    • “In fact, more frequent micro-awakenings go hand in hand with that genetic risk, long before any memory problems arise, according to a team from the University of Liege in Belgium. 
    • “Sleep could become an accessible marker for the early identification of vulnerable individuals,” senior researcher Gilles Vandewalle said in a news release.
    • “It’s well-known that people with Alzheimer’s have sleep problems, but sleep hasn’t been established as an early indicator of the disease, researchers noted.”
  • The Wall Street Journal informs us,
    • “AstraZeneca AZN  said it is ending the Phase 3 trial of volrustomig plus chemotherapy for metastatic non-small-cell lung cancer.
    • “The Cambridge-based pharmaceutical company said Monday that the decision is based on the recommendation of the Independent Data Monitoring Committee after a planned review of trial data.
    • “The committee concluded that the volrustomig combination was unlikely to reach either of the primary endpoints for the drug in the eVolve-Lung02 trial.” * * *
    • “The other Phase 3 volrustomig trials will continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.
    • “Separately, AstraZeneca said Tagrisso plus Orpathys showed a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival in a Phase 3 trial in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer.” * * *
    • “The company said this was the first global Phase 3 trial to show significant progression-free and overall survival benefits in this setting.
    • “Tagrisso plus Orpathys is being jointly developed with Hutchmed, but is being solely commercialized by AstraZeneca.
    • “AstraZeneca also said a Phase 3 trial of Enhertu showed a significant and clinically meaningful improvement in progression-free survival as a treatment for unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small-cell lung cancer.”
  • BioPharma Dive points out,
    • “Shares for Argenx soared over 13% Monday morning after the company announced positive data from a Phase 3 trial for a rare autoimmune condition that could expand use of its blockbuster drug Vyvgart. 
    • “The Dutch biopharmaceutical company said Monday an under-the-skin injection version of Vyvgart, called Vyvgart Hytrulo, met its primary endpoint in a late-stage combined study of people with myositis, a rare autoimmune disease that attacks the muscles and has limited treatments. The company said that Vyvgart, when compared to placebo, showed improvements in two subsets of the disease, as measured by a scale evaluating muscle strength and physical health known as Total Improvement Score, or TIS.”
  • and
    • “EyePoint, a Boston-area biotechnology company, lost nearly a billion dollars in market value Monday after its main drug failed to hit the central goal of a key clinical trial.
    • “Titled LUGANO, the trial enrolled roughly 400 people with the less common “wet” form of age-related macular degeneration, meaning they have impaired vision because of abnormal, fluid-leaking blood vessels in their eyes. They received inside-the-eye injections of either “aflibercept,” the active ingredient in Regeneron Pharmaceuticals’ blockbuster medicine Eylea, or EyePoint’s drug, which the company has branded as Durayvu.
    • “Researchers then evaluated these participants for a little over a year, with a particular focus on any changes in average “best-corrected visual acuity” — a measure of how clearly a person, when outfitted with optimal prescription lenses, can read the kind of standard eye chart found in an optometrist office. EyePoint has now revealed that, on that measure, across the trial’s full dataset, its drug didn’t prove “non-inferior” to aflibercept.
    • “The company largely blamed the failure on an “asymmetric cohort” of nine patients in the Durayvu-treated group, who had vision loss — or a dropoff of at least 15 letters on the eye exam — that was “unrelated to wet AMD.” According to EyePoint, an after-the-fact analysis found the drug would have achieved non-inferiority had that group been excluded.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente reported nearly $1.7 billion in operating income (4.6% operating margin) during the second quarter of 2026, a more than $600 million improvement over the same period in 2025. 
    • “The country’s largest nonprofit health system, in a quarterly financial update shared Friday that precedes its more granular regulatory filing, outlined $35.6 billion in operating revenues, a 10.9% year-over-year increase, and nearly $34 billion in operating expenses, a 9.3% year-over-year increase.
    • “Kaiser noted that its structure as a membership-based, premiums-collecting integrated health system typically yields stronger operating income in the first half of the calendar year “due to health plan enrollment cycles,” moderating later on “as care utilization, labor costs, and other expenses increase while revenue stays relatively flat.”
    • “The quarter’s performance follows an opening frame in which the organization’s $711 million operating income (2.1% operating margin) reflected a pullback from early 2025’s $932 million operating gain (2.9% operating margin), due in part to a major month-long work strike. Year to date, that still places Kaiser and its subsidiaries about $400 million ahead of 2025. 
    • “In today’s complex health care environment, positive operating performance helps us make care more affordable, invest in our future, and expand access to value-based care,” Kaiser Permanente Chair and CEO Greg A. Adams said in a statement. “Together, Kaiser Permanente and Risant Health are helping more people benefit from evidence-based, coordinated care that improves quality, enhances the patient experience, and makes high-quality care more accessible and affordable. I’m grateful to our employees and physicians for bringing our mission to life every day.”
  • Beckers Payer Issues relates,
    • “Blue Cross Blue Shield of Massachusetts earned $83.4 million in after-tax second-quarter profit. 
    • “This was made up of $35.7 million in operating and other income, as well as $47.7 million in investment income. The insurer’s revenue was $2.7 billion, marking a net margin of 3%. During the same period in 2025, BCBS Massachusetts had a $129.7 million loss on revenue of $2.6 billion.
    • “Since the beginning of the year, after-tax net income has been $142.9 million with revenue at $5.4 billion, a 2.7% net margin. The results include a premium deficiency reserve.
    • “After two consecutive years of record losses, we are also laser focused on restoring our company’s financial health,” Executive Vice President and CFO Ruby Kam said in an Aug. 14 news release. “We are doing this by carefully managing our own administrative costs and making necessary adjustments to our pricing and benefits.”
  • Healthcare Dive tells us,
    • “Universal Health Services has completed its $835 million acquisition of online therapy provider Talkspace, bolstering the for-profit system’s already extensive behavioral health offerings.
    • “The deal closed Monday five months following its announcement, after the companies secured necessary regulatory approvals.
    • “With the buy, UHS will be able to provide a full range of behavioral health services, including inpatient, intensive outpatient, partial hospitalization, therapy sessions and virtual assessments.”
  • Beckers Clinical Leadership adds,
    • “Salt Lake City-based Intermountain Health is approaching behavioral health access challenges by first addressing one quality concern in particular: whether patients are actually getting better.
    • “That’s the premise behind the health system’s push to embed measurement-based care across its behavioral health service line, Tammer Attallah, executive clinical director of Intermountain’s behavioral health clinical program, told Becker’s. The nonprofit system has locations in six primary states and additional operations across the western U.S., operating 34 hospitals and more than 400 clinics.
    • “We want more patients to get better faster. That’s all,” he said. “It’s as simple as that.” 
  • Beckers Physician Leadership informs us,
    • “Three physician leaders shared what they believe healthcare organizations and the system as a whole need to stop asking of physicians, pointing to burdensome technology, systemic dysfunction and workflows that pull clinicians away from patient care. 
    • “James Augustine, MD. Medical Director for Lee County EMS (Fort Myers, Fla.): Mandated use of very unfriendly computer systems, which don’t contribute to good practice.
    • “Peter Bravos, MD. Chief Medical Officer of Sutter Health’s Surgery Center Division (Yuba City, Calif.): Asking physicians to personally absorb systemic dysfunction and calling it resilience. When the schedule is broken, the staffing is thin, and the administrative load keeps climbing, a wellness webinar isn’t a solution. It’s a way of relocating a system’s problem onto the individual and then measuring the individual for how well they cope with it. Resilience was never meant to be a substitute for fixing the conditions that exhaust people. Build systems worthy of the people working in them, and resilience takes care of itself.
    • “Walter Allen Fink, DO. Associate Vice President and Chief Medical Officer UT Health San Antonio: We need to stop putting unnecessary things between physicians and the work they were educated and trained to do.
    • “Too much physician time is spent working around inefficient processes, navigating technology, dealing with fragmented workflows, and doing tasks that do not really require a physician’s expertise.
    • “For me, this is bigger than just reducing administrative burden. We should be designing systems that allow physicians to spend more of their time caring for patients, making complex clinical decisions, talking with patients and families, and improving care.”
  • Fierce Healthcare notes,
    • “Since April, more than 300 enterprise health systems have adopted Abridge’s artificial intelligence-based decision support solution, and the company is now making the tool available to every clinician at its partner health systems.
    • “It’s part of Abridge’s strategy to broadly expand from AI documentation to functioning as an enterprise AI assistant for clinicians.
    • “Adoption of decision support has outpaced anything we’ve shipped before because it feels like a natural extension of Abridge. It understands the context of the patient in front of the clinician, it’s grounded in the evidence they already trust, and it connects to what they want to do next,” Shiv Rao, M.D., CEO and co-founder of Abridge, and a practicing cardiologist, said in a statement.

Midweek update

David Ermer–Agentic & Generative AI, AHRQ, CDC, CMS, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, No Surprises Act, Rx coverage, Telehealth, 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) today announced a $4 million initiative to expand access to rapid, point-of-care syphilis testing, with a focus on reaching women in emergency departments and other nontraditional healthcare settings.
    • “Congenital syphilis is preventable, yet too many mothers and babies are still suffering its devastating consequences,” said HHS Secretary Robert F. Kennedy Jr. “HHS is putting rapid tests where women receive care so we can detect infections earlier, treat them faster, and protect more babies.”
  • Beckers Behavioral Health adds,
    • “HHS Secretary Robert F. Kennedy Jr., White House Office of National Drug Control Policy Director Sara Carter, and Housing and Urban Development Secretary Scott Turner released a toolkit Aug. 12 focused on addressing homelessness and addiction through treatment.
    • “The “Best Practices Toolkit: Addressing Homelessness and Addiction Through Treatment First” outlines strategies for communities to “help Americans transition from homelessness and addiction to recovery and self-sufficiency,” according to an Aug. 12 news release from HHS.
    • “The toolkit centers on a “Treatment First” model, which prioritizes coordinated and accountability-driven engagement in evidence-based treatment and recovery support services. It supports drug treatment and recovery efforts through the Great American Recovery Initiative.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services today released an advisory for certain clinicians who are qualifying alternative payment model participants and eligible to receive APM incentive payments, notifying them that their current billing information must be updated to receive funds for the 2026 payment year. CMS said that it was unable to identify a taxpayer identification number associated with some participants after processing 2026 APM incentive payments and therefore was unable to disburse payments. The agency said that all information must be received by Oct. 13. Following that date, CMS said any claim to an APM incentive payment for the 2026 payment period based on an eligible clinician’s qualifying APM participant status for the 2024 performance period will be forfeited.” 
  • Beckers Hospital Review adds,
    • “Participation in mandatory value-based payment programs from CMS is associated with significantly higher annual administrative costs for hospitals, according to a study published Aug. 7 in JAMA Health Forum.
    • “Researchers at the Brown University School of Public Health in Providence, R.I., examined 2006 to 2020 Medicare cost report data for 4,332 hospitals, including 2,820 that participated in the Hospital Value-Based Purchasing program, Hospital Readmissions Reduction Program and Hospital-Acquired Condition Reduction Program. They also assessed costs associated with participation in the Comprehensive Care for Joint Replacement model. * * *
    • “Participation in the first three programs was tied to annual administrative cost increases ranging from $650,000 per hospital compared with long-term acute care hospitals to $1.23 million compared with general acute care hospitals in Maryland. Participation in the CJR model was linked to a $1.4 million annual increase in administrative costs per hospital.
    • “Aggregated nationally, the programs accounted for more than $3 billion in additional annual administrative spending.”
  • Beckers Clinical Leadership tells us,
    • “HHS is creating a new pathway to evaluate which conditions should be added to the national newborn screening panel as part of a broader effort to modernize a review process that officials say has lagged behind advances in genetic medicine.
    • “The Health Resources and Services Administration on Aug. 11 launched a framework to streamline evidence reviews for the Recommended Uniform Screening Panel, the federal guideline nearly all state newborn screening programs follow. 
    • :A Federal Register notice published Aug. 12 laid out the mechanism: a National Newborn Screening Stakeholder Workgroup funded through a $700,000 award to the Silver Spring, Md.-based Association of Public Health Laboratories.”

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

  • My Federal Retirement reports,
    • “Based on CPI-W data through July 2026, the trend toward an estimated 2027 COLA holds at 3.1% for Social Security and CSRS retirees, which would translate to a FERS COLA of approximately 2.1% once the FERS reduction formula is applied — unchanged from last month’s estimate. The official 2027 COLA won’t be announced by the Social Security Administration until mid-October 2026. This page is updated monthly as new CPI-W data is released.”

From the Food and Drug Adminstration front,

  • The Hill reports,
    • The Food and Drug Administration (FDA) is assuring Americans that they should feel confident eating fresh produce again, seeking to ease concerns over the nation’s food supply after a cyclospora outbreak linked to iceberg lettuce spread across more than a dozen states.
    • “We have the safest food supply in the world,” acting FDA Commissioner Kyle Diamantas said in a Tuesday interview with CNBC. “Americans should feel confident in eating fresh produce including leafy greens at this point.
    • “Diamantas added that his agency “remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market” since California-based vegetable producer Taylor Farms voluntarily recalled products linked to the outbreak on July 17.” * * *
    • “The FDA and CDC are still investigating the outbreak, and officials have warned that the number of confirmed illnesses could continue to climb long after the recall because it can take as long as six weeks to determine whether an illness is connected to the outbreak.”
  • Medscape relates,
    • “Following unprecedented results from the RASolute 302 trial, cancer centers across the US are making daraxonrasib available to patients ahead of FDA approval.
    • “The RAS inhibitor has been in the news since it was shown to nearly double median overall survival vs standard chemotherapy — from 6.7 to 13.2 months — among patients with previously treated metastatic pancreatic cancer.
    • “The survival gain, in a notoriously difficult-to-treat disease, earned a standing ovation when the data were presented at this year’s American Society of Clinical Oncology annual meeting. And on July 22, daraxonrasib’s maker Revolution Medicines, announced that the FDA had accepted its approval application.”
  • Beckers Hospital Review tells us,
    • “San Francisco-based Hims & Hers plans to start selling compounded peptides by the end of 2026, with six more to follow pending final FDA rulemaking, executives said Aug. 10.
    • “The direct-to-consumer telehealth company laid out a phased rollout on its second-quarter earnings call. Executives said they expect to offer a first group of already-permitted peptides — including sermorelin, glutathione and a product it markets as MEDplus — by year’s end, then expand to six wellness peptides an FDA advisory committee recommended in July.
    • “We are currently developing a best-in-class peptide experience including U.S.-manufactured products, clinical-led guidance and ongoing blood testing,” co-founder and CEO Andrew Dudum said. He said the company is “waiting on full and final rulemaking from the FDA” before launching the recommended peptides.”

From the judicial front,

  • Bloomberg Law reports,
    • “The full Fifth Circuit partly struck down a series of federal rules on surprise medical bills, concerning the qualifying payment amount, or median in-network rate. 
    • “The court overturned a provision allowing insurers to include “ghost rates” in the QPA, and rejected a provision excluding bonuses and case-specific rates from the QPA. 
    • “The court sided with the agencies on a provision excluding one-time, case-specific agreements from the QPA calculation, saying the word rate “connotes a per-unit price for multiple units.”
  • Beckers Hospital Review adds,
    • “The court said the agencies can use their enforcement discretion to let insurers keep using existing QPAs while new calculations are completed, preserving balance billing protections for patients in the interim.”
  • The Wall Street Journal relates,
    • “Eli Lilly filed six lawsuits against U.S. entities it alleges are selling a version of its investigational weight-loss drug on the black market.
    • “The lawsuits claim the entities sell retatrutide, a GLP-1 drug that is still in trials and not yet approved by the FDA.
    • “Eli Lilly is calling on social media platforms and payment processors to help stop the black market sales of the drug.”

From the NCQA front,

  • The Cotiviti Blog tells us,
    • “Many health plans wrapped up Measurement Year (MY) 2025 with a smoother HEDIS® season than ever before. The organizations that performed best weren’t necessarily those with the largest teams or budgets—they were the ones with integrated data, aligned workflows, and the ability to identify and act on quality opportunities earlier.
    • For many health plans, MY 2025 brought an unexpected outcome: fewer fire drills. The most successful organizations relied on repeatable steps focused on:
      • Integrated clinical and quality data
      • Aligned teams around clear priorities
      • Chart review productivity reporting
      • Population-level measures dashboards
    • Established repeatable workflows that reduced operational friction throughout the season
    • High-achieving plans started by identifying the right opportunities by using HEDIS logic and integrated data sources to pinpoint the gaps that matter most. Effective approaches centered on opportunities where both impact and intervention are possible, targeting outreach at the provider, care manager, or member level depending on where change can occur most effectively.
    • Next, operationalizing those insights was key during MY 2025. Analytics may reveal performance gaps, but improvement happens when those findings are embedded directly into workflows. Plans that consistently outperform their peers translate data into outreach campaigns, care management activities, and provider engagement efforts with clearly defined accountability.
    • Standardization is equally important. Quality initiatives only create value when the work performed is accurately reflected in reporting. Aligning documentation and coding practices with NCQA-approved value sets helps ensure that quality improvements appear in measure results.
    • Finally, leading health plans embrace continuous measurement. They evaluate intervention effectiveness, monitor gap closure rates, assess outcomes, and create feedback loops that help refine future strategies. Over time, this transforms quality programs from a series of one-off campaigns into a scalable operating model built around continuous improvement.

From the public health and medical / Rx research front,

  • MedPage Today tells us,
    • “Wait times are increasing between cancer diagnosis and the start of first-course therapy for six cancer types, according to a retrospective cohort study.
    • “Predictors of longer wait times included Medicaid insurance, lowest-quartile income, Black race, increased travel distance, and treatment at academic institutions, among other factors.
    • “These results should be considered in the context of previous research linking treatment delays with worse survival outcomes, researchers said.”
  • Beckers Hospital Review notes,
    • “Ascension Saint Thomas in Nashville has rescheduled some elective surgeries and said it could be forced to cancel or delay additional cases because of shortages of blood products.
    • “Platelets are a particular concern at Saint Thomas, according to an Aug. 6 news release from the hospital, which is part of the St. Louis-based Ascension health system. Chief Clinical Officer Brian Wilcox, MD, told NBC News affiliate WNKY that the shortage is affecting hospitals nationwide as donations of blood products have fallen to a four-year summer low even as demand for transfusions holds steady.
    • :The disruption comes as the American Red Cross declared its second national blood crisis in history July 27, with type O blood critically scarce and distributions to hospitals now limited. The shortage began building in May, when a gap widened between the amount of blood hospitals need and the amount being donated. The Red Cross is currently sending hospitals roughly 3,500 more units of blood per week than expected.
    • “An Illinois Red Cross spokesperson told NBC News affiliate WGEM that without a constant blood supply, hospitals could be forced into situations where doctors have to choose who gets blood and who doesn’t, adding that elective surgeries that need transfusions may have to be postponed.”
  • Cardiovascular Business adds,
    • “Clinicians should pay close attention to any incidental lung findings identified when transcatheter aortic valve replacement (TAVR) patients undergo preprocedural CT scans. That is according to new findings published in Heart Lung, a journal from the American Association of Heart Failure Nurses.[1]
    • “Over the past decade, TAVR has transformed the therapeutic landscape of symptomatic severe aortic stenosis (AS),” wrote first author Mustafa Mousa Basha, MD, a researcher with University Hospital Bonn in Germany, and colleagues. “Pulmonary diseases are frequently co-existent in AS patients, often ranging from mild restriction to a mixed restrictive and obstructive pattern, and represent an important risk factor for postoperative complications following TAVR.”
  • STAT News relates,
    • “Not long after guidelines shifted to considering statin therapy as early as age 30, new research from France suggests there may be no harm in stopping the cholesterol-lowering drugs at age 75 in people with no history of cardiovascular disease. The lessons, however, may not translate elsewhere. 
    • “The “non-inferiority” study, published Tuesday in the Lancet Healthy Longevity, does not advise doctors to tear up statin prescriptions for older people. Nor does it conclude that going off statin therapy is better than staying on. It does say patients should talk to their doctors to see if they’d be no worse off for dropping the daily pills.
    • “Invoking patient choice, the authors highlight the lack of scientific literature on older people, noting what research does exist has found the link between cholesterol and cardiovascular events weakens with age. They believe their own study needs to be repeated for a longer period of time and extended to populations at higher cardiovascular risk or otherwise not as healthy as their participants.
    • “For the majority of American patients over the age of 75, this trial will not change anything,” Romit Bhattacharya, a general and preventive cardiologist from the Mass General Brigham Heart and Vascular Institute, told STAT in an interview. He was not involved in the research. “It does give us a little bit of permission and greater flexibility and choice for our individuals who maybe have a short time horizon to live and who are already quite healthy and engaged in care.”
  • The New York Times reports,
    • “President Trump issued an executive order this week calling for immunizations for measles, mumps and rubella, a mainstay of vaccination programs worldwide, to be offered as three individual jabs given at separate times, instead of in one combination shot.
    • “In an Oval Office signing ceremony, the president made a frightening and unsubstantiated claim about the combination shot. “Together, there could be a possibility they’re quite lethal.” 
    • “Researchers have not linked the combination M.M.R. shot to a risk of death, and there is no evidence that it is dangerous or that splitting it into its three components is any safer or more effective, vaccine experts said. Combination shots for the diseases have been used in the United States since 1971, and were introduced only after careful comparison against individual shots. They have been given to hundreds of millions of children.
    • “What’s more, separate vaccines for measles, mumps or rubella have not been available in the United States for many years. Vaccine manufacturers said it would take a minimum of five to 10 years for them to be tested and made available.”
  • Health Day informs us,
    • “Restarting obesity medications, including glucagon-like peptide-1 (GLP-1) receptor agonists, soon after sleeve gastrectomy (SG) surgery is associated with greater one-year weight loss than surgery alone in adolescents, according to a research letter published online July 22 in JAMA Surgery.”
  • and
    • “The 4C meningococcal B (MenB) vaccine confers modest protection against gonorrhea among adolescents, according to a study published online Aug. 4 in Open Forum Infectious Diseases.”
  • Genetic Engineering and Biotechnology News points out,
    • :A multi-disciplinary, multi-institutional group of researchers said they relied on their expertise in genetics, mechanics, chemistry, and biology to create a chip the size of a postage stamp to model a particular class of heart conditions.
    • “The team, led by Guang Li, PhD, an associate professor in the University of Pittsburgh School of Medicine’s department of cell biology, has grown heart valves on organoids. The study “Human iPSC-derived heart valve-like assembloids model valve development and disease pathology” appears in Cell Stem Cell and is an important step toward better understanding and treating a number of serious heart disorders, according to the scientists.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of baxdrostat (Baxfendy™, AstraZeneca) and lorundrostat (Mineralys Therapeutics, Inc.) for hypertension.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.” * * *
    • The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on September 9, 2026.

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

  • The Austin American-Statesman reports,
    • “On Wednesday, the University of Texas System Board of Regents’ Facilities Planning and Construction Committee will adopt a timeline and budget for phase one of the much-awaited artificial intelligence-native hospital, UT Dell Medical Center. 
    • “Construction on the $5 billion hospital is expected to begin this fall, and initial site preparation could begin within a month after board approval of this first phase, which does not include the actual building but includes design and site preparation as well as equipment that takes time to arrive such as MRIs. The committee’s agenda includes information such as a timeline and the cost of the project, which has not yet been disclosed publicly. 
    • “The hospital will include both specialty care and an MD Anderson Cancer Center Central Texas location. UT announced the project in 2023 as a $2.5 billion investment to expand access to high-quality healthcare for Central Texas and bring thousands of jobs to Austin, but when a new site chosen and the hospitals were combined into one, the price tag went up to an estimated $5 billion.” 
  • Modern Healthcare relates,
    • “Intermountain Health and AdventHealth have signed a definitive agreement to merge services at multiple hospitals, clinics and medical practices through a joint venture in the Denver area. 
    • “The deal is slated to close in early 2027, pending regulatory approval, according to a Wednesday notice from AdventHealth. The organizations signed the definitive agreement last week.
    • “Financial terms were not disclosed.”
  • KFF Health News explains how “Hospital Prepayment Requirements Add New Wrinkles to Patients’ Financial Responsibility.”
  • Beckers Health IT tells us,
    • “Bethlehem, Pa.-based St. Luke’s University Health Network and UnitedHealthcare have automated claim status updates for 88% of the claims exchanged between the two organizations, using Epic’s Payer Platform, according to Epic’s newly released 2026-2027 Almanac.
    • “The two organizations turned on Epic’s Claim Status feature to give St. Luke’s staff real-time visibility into where claims stand with UnitedHealthcare, replacing manual status checks that previously required calling the payer or logging into external portals. Brian Burd, IT director at St. Luke’s, said the health system’s main motivation was to improve revenue cycle efficiency by reducing manual claim status inquiries and speeding up follow-ups.
    • “UnitedHealthcare manages most of its claims operations outside Epic, so the insurer routes claim data through its own Epic environment first, then delivers it to St. Luke’s through the Payer Platform connection. That setup avoided the time and transaction fees of building a separate direct link between the two systems.
    • “Since the feature went live, UnitedHealthcare has seen a 25% drop in claim status calls from St. Luke’s, while St. Luke’s staff have shifted their time from chasing payer updates to higher-value revenue cycle work.”
  • Beckers ASC Review informs us,
    • “There comes a point when health system’s ASC moves stop being a side project and start requiring a more involved strategy, and, according to Atlas Healthcare Partners CEO Aric Burke it’s when revenue is above roughly $2 billion to $3 billion, and a portfolio has grown past about five centers.
    • “I think health systems over two to three billion in revenue probably need to have a real, dedicated ASC strategy,” Mr. Burke told Becker’s.”
  • and 
    • “Anesthesia has become one of the most persistent staffing headaches for ASCs and hospitals alike.
    • “It’s not just a bad labor market, but a pipeline problem stacked on top of an aging workforce, a bottlenecked training system and a reimbursement environment that’s making it harder to attract new anesthesiologists and certified registered nurse anesthetists into the specialty.”
  • and
    • “GI procedure demand keeps climbing while Medicare keeps cutting what it pays for the exact setting where those procedures are cheapest to perform.”
  • Beckers Hospital Review notes,
    • “U.S. News & World Report released its debut ratings Aug. 12 for the best GLP-1 telehealth platforms, its first evaluation of the online companies prescribing brand-name weight loss drugs.
    • “The media company rated 20 platforms offering FDA-approved, brand-name GLP-1 medications, including Wegovy, Zepbound, Ozempic and Foundayo, according to an Aug. 12 news release. Companies that offer only compounded GLP-1s were excluded, and for platforms selling both, U.S. News evaluated only the branded portion of the business.”
    • Here are the top five:
      • “Amazon One Medical: 4.8
      • “Found: 4.6
      • “Mochi Health: 4.4
      • “Ro: 4.4
      • “Noom: 4.3”
  • MedTech Dive lets us know,
    • “Abbott and Google plan to pair Abbott’s over-the-counter glucose sensor with Google’s artificial intelligence and consumer technology, the companies said Tuesday.
    • “The multiyear partnership is focused on making metabolic insights from Abbott’s device easier to use, helping people proactively manage their health. 
    • “The two companies plan to launch a large study that could inform Google’s AI health coaching and future features for Abbott’s Lingo sensor. Abbott did not disclose how many people they plan to enroll in the study.”

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.