Friday report

Obesity

Friday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front

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

From the public health and medical / Rx research

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

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

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

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “The timeline is slipping for senators to strike a bipartisan deal on a short-term funding patch before their August recess as leadership struggles to work out the finer details.
    • “Senior appropriators had been hopeful of unveiling text before the weekend for a stopgap measure expected to keep the government funded into early December. But sources say leaders are now more likely to release text later this weekend or early next week amid snags over a federal grant rule and other add-ons.
    • “The Trump administration’s proposed rule would give senior political appointees greater influence over the grant approval process and has drawn pushback from appropriators on both sides of the aisle.
    • “Senate Appropriations Chair Susan Collins, R-Maine, noted Thursday that the rule has drawn considerable criticism from “a wide range of groups.”
    • “So, I hope we’ll take advantage of this opportunity to delay it,” she said. “But that’s up to the leadership. It’s obviously not a funding issue.”
    • “The grants dispute is among the last-minute hitches and “anomalies” that negotiators have said leadership is sorting through as senators aim for floor consideration next week.
    • “The Senate is currently scheduled to take a procedural vote Monday on the legislative vehicle for the continuing resolution that is needed to stave off a partial government shutdown on Oct. 1, when the new fiscal year begins.
    • “The House has already passed a Republican-crafted stopgap bill to extend current funding through Dec. 4. But senators say further “anomalies,” or deviations from current spending, are needed, noting the gap between add-ons requested by the White House and the House GOP’s bare-bones funding patch.”
  • Bloomberg Law relates,
    • “The Trump administration will increase Medicare payments for hospital services by 2.3%, or $2.1 billion in fiscal year 2027, according to a final rule released Friday.
    • “The final rule (RIN 0938-AV79) from the Centers for Medicare & Medicaid Services also includes a 2.2% reimbursement bump of $54 million for long-term care hospitals, along with several new hospital quality reporting measures.
    • “These include the adoption of quality measures for diabetes, deep vein thrombosis/pulmonary embolisms, quality care planning, and mortality rates. 
    • “The final rule also expands the agency’s Comprehensive Care for Joint Replacement (CJR) Model, which holds hospitals financially accountable for the quality and cost of hip, knee, and ankle replacements, through incentive payments
    • “The agency says the program has produced strong evidence of cost savings while maintaining quality of care. 
    • “The mandatory model will now be expanded nationwide beginning Jan. 1, 2028.”
  • Beckers Hospital Review points out nine things to know about today’s rule.
  • Here’s a link to CMS’s Fact Sheet on today’s rule.
  • The American Hospital Association News adds.
    • “The Centers for Medicare & Medicaid Services today finalized a 2.3% payment update for long-term care hospitals for fiscal year 2027 relative to FY 2026. This includes a 3.2% market basket update, reduced by a 0.9 percentage point productivity adjustment. In addition, CMS finalized its decision to freeze the outlier threshold at $78,936, the same level as FY 2026. For the LTCH Quality Reporting Program, CMS finalized the removal of two measures related to COVID-19 vaccination and a shortened data reporting timeline.
    • :In a statement shared with media today, Joanna Hiatt Kim, AHA’s vice president of payment policy, said, “[W]e remain concerned about continued inadequacies in the LTCH payment system that have contributed to declining patient volumes and the closure of facilities across the country, threatening access to care for medically complex patients. Although the AHA appreciates that CMS did not further raise the outlier threshold in this final rule, broader reforms are needed to support the LTCH field. We remain committed to working with the Administration and Congress to advance the AHA’s LTCH reform principles and promote a more sustainable payment framework that preserves patient access to LTCH services.”
  • The American Hospital Association News further informs us,
    • “The Department of Health and Human Services today issued a notice announcing a revised 340B Rebate Model Pilot Program, allowing qualifying drug manufacturers to use rebates rather than upfront discounts to effectuate the 340B ceiling price for certain drugs purchased by 340B covered entities. 
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “The AHA is deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients. The agency’s analysis dramatically understates the true costs of this program, ignoring the hundreds of millions of dollars in compliance expenses, cash-flow disruptions, and operational burdens that will inevitably divert scarce resources away from patient care. At a time when many hospitals are already under severe financial strain, this policy will force hospitals in rural and other underserved communities to spend more on bureaucracy and less on the services and care that patients depend on every day. As we continue to review today’s notice, the AHA is considering all available options to prevent this flawed program from going into effect.” 
    • “HHS’ Health Resources and Services Administration said the pilot is designed to test a rebate-based approach for a set of drugs while gathering information on program integrity, operational impacts and the interaction between the 340B program and Medicare’s Drug Price Negotiation Program. The pilot is limited to drugs included on the Centers for Medicare & Medicaid Services Medicare Drug Price Negotiation Selected Drug Lists for initial price applicability years 2026 and 2027. 
    • “Under the notice, manufacturers that wish to participate must submit plans to HRSA by Aug. 24. HRSA said it will make approval decisions by Sept. 24, and approved rebate models will take effect Jan. 1, 2027. Participating manufacturers must commit to the pilot for at least one year. “
  • Per an HHS news release,
    • ‘The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $73.2 million in grants to strengthen children’s mental health services, suicide prevention programs, and to expand assisted outpatient treatment (AOT) to those with serious mental illness.”
  • OPM posted in the Federal Register today direct final rules (previously known as interim final rules with opportunity for public comment)
    • FLSA Claims and Compliance
      • to update the provisions concerning Fair Labor Standards Act (FLSA) claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • and
    • Procedures for settling claims
      • to update the provisions concerning administrative claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today issued governmentwide guidance to departments and agencies on preparing Fiscal Year 2027 Annual Staffing Plans, advancing the Trump Administration’s efforts to modernize federal workforce planning, strengthen merit-based hiring, and ensure agencies are strategically positioned to deliver efficient, high-quality services to the American people.
    • “The guidance implements Executive Order 14356, Ensuring Continued Accountability in Federal Hiring, and provides agencies with a framework for conducting rigorous, bottom-up workforce planning that prioritizes mission-critical positions, modern technology talent, and early career hiring while improving governmentwide visibility into staffing needs.
    • “Annual Staffing Plans will require agencies to identify workforce needs based on mission requirements—not historical staffing levels—and reserve budget and positions for critical hiring priorities, including artificial intelligence, cybersecurity, software engineering, and other technology roles. The guidance also directs agencies to leverage governmentwide hiring initiatives such as US Tech Force and the Early Career Talent Network to improve hiring quality, reduce duplication, and accelerate recruitment across the federal government.”
  • Kevin Moss, writing in Federal News Network, explains “How a household with two federal employees can save on their FEHB premiums by enrolling self-only.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, a disease previously known as metastatic hormone-sensitive prostate cancer.
    • “The July 31 approval expands the use of Pluvicto to patients whose prostate cancer has spread but has not yet become resistant to hormone therapy. The treatment is intended for patients whose tumors express prostate-specific membrane antigen (PSMA), a protein found on many prostate cancer cells.”
  • MedTech Dive relates,
    • “Surgical robotics company MMI has received the Food and Drug Administration’s approval to expand an early feasibility study of microsurgery for Alzheimer’s disease.
    • “The REMIND study is evaluating the safety and feasibility of using MMI’s Symani robotic system in microsurgery procedures to re-establish drainage pathways in the deep cervical lymph nodes of patients with neurodegenerative disease. Patients in the trial also have confirmed lymphatic abnormalities.
    • “The FDA gave MMI the go-ahead to expand the number of people who can enroll in the study to 15, from up to five in the initial group, the company said Thursday.”
  • The American Journal of Managed Care lets us know,
    • “Late last week] six peptides received narrow advisory support for potential 503A Bulks List inclusion, an atypical outcome given FDA staff recommendations against all seven under review. 
    • “Legal compounding remains prohibited absent FDA acceptance and completion of proposed and final rulemaking; none of the substances is FDA-approved. 
    • “FDA reviewers cited short, underpowered studies insufficient for safety/efficacy across proposed indications, including limited BPC-157 trial data. 
    • “Committee reconstitution drew conflict-of-interest scrutiny, with increased representation from clinicians and businesses involved in prescribing, producing, or promoting peptides. 
    • “Payers should expect persistent cash-pay utilization and unregulated online procurement, necessitating rigorous medication reconciliation and adverse-event monitoring given sparse human safety data.”

From the judicial front,

  • Per a Justice Department news release,
    • “New York ophthalmology practices Mark D. Fromer, P.C. doing business as Fromer Eye Centers and Floral Park Ophthalmology P.C. have agreed to pay a total of $2.3 million to resolve alleged violations of the False Claims Act arising from their billing for trans-cranial doppler ultrasounds (TCDs) through a kickback arrangement with a third-party testing company. The Estate of Mark Fromer, the former owner of Fromer Eye Centers, also joined in the settlement with the practice. Both practices have agreed to cooperate with the Justice Department’s ongoing investigations of other participants in the alleged scheme.” * * *
    • “The claims resolved by the settlements are allegations only and there has been no determination of liability.“

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 31, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Considering multiple data sources, COVID-19 activity is low and stable nationally but is beginning to show early signs of an increase in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) confirmed 53 new US measles cases this week, bringing the total for the year to 2,371 cases.
    • “All but 16 of the cases were locally acquired in 45 US jurisdictions, with the rest tied to international travel, the CDC said in its weekly update. There have been 37 new measles outbreaks reported this year, with 94% of cases associated with outbreaks (defined as three or more cases).” * * *
    • “Among the current measles hotspots is Pennsylvania, which has reported 31 new cases over the past seven days and now has 167 cases for the year, according to the Pennsylvania Department of Health. Officials in neighboring Ohio yesterday confirmed four new cases in unvaccinated individuals in Ashtabula and Tuscarawas counties. It’s Ohio’s third measles outbreak this year.”
  • The American Journal of Managed Care gives us “FAQs: Cyclospora Recovery, Treatment, and Outbreak Prevention Strategies.”
    • “Epidemiologic and traceback evidence implicates shredded iceberg lettuce from Taylor Farms de Mexico as the exposure source, despite a disclosed false-positive border test not changing investigation conclusions. 
    • “Symptom onset typically occurs about one week post-exposure and includes profuse watery diarrhea, anorexia, nausea, bloating, weight loss, and fatigue, while some infections remain asymptomatic. 
    • “Higher-risk groups include immunocompromised patients, older adults, and those with limited care access, who may need longer antibiotic courses and closer monitoring for dehydration and prolonged illness. 
    • “TMP-SMX is the treatment of choice but requires individualized risk–benefit assessment given adverse reactions and a clinically meaningful, though comparatively lower, association with C difficile. 
    • “Public health control relies on clinician/lab case reporting, standardized exposure questionnaires, and FDA traceback; absent whole-genome sequencing for Cyclospora, marker-based genotyping supports source identification.”
  • The Wall Street Journal adds,
    • “In the verdant fields of California’s Salinas Valley, Larry Cox is watching his lettuce wilt.
    • “Cox and his two sons run Coastline Family Farms, which supplies leafy greens to some of the country’s biggest restaurant chains and grocery stores. But this week, in the region known as America’s Salad Bowl, around 300,000 pounds of his romaine hearts were chopped and plowed back into the soil.
    • “There is no evidence that his, or any of the nation’s homegrown lettuce, was infected with the parasite behind an illness outbreak that has sickened thousands of people so far. Even so, that hasn’t stopped Cox’s dependable restaurant and grocery customers from cutting back on orders.
    • “Many growers are destroying the crops they can’t find buyers for. Since lettuce has about a 30-day growing cycle, farmers that are plowing their crops back into the ground are weighing whether to replant or dial back. 
    • “It is incredibly demoralizing,” Cox said. “I would’ve been better off taking a vacation in the South of France than planting the crop.”
  • USA Today relates,
    • “As electric bikes and scooters become an increasingly common way for young people to get around, injuries tied to the devices are climbing at an alarming rate.
    • “New research from Truveta, a health data and analytics firm supported by a coalition of 30 U.S. health systems, analyzed over 12,000 emergency room visits nationwide. The findings revealed that injury rates associated with e-bikes and e-scooters among children and adolescents surged 7.5-fold between January 2023 and May 2026, an increase compared to the rates seen in adults.
    • “ER visits related to e-bikes and e-scooters have increased by 671% for children and adolescents, said Karen Gilbert Farrar, PhD, lead researcher at Truveta. “Just to put that in context, that’s if one patient is was being seen in 2023, that’s now nearly eight patients in 2026.”
    • “The findings also highlight the severity of many crashes: more than one-third of injured patients suffered head or neck injuries. And nearly 7% of child and adolescent visits that were related to e-bike and e-scooter use involved traumatic brain injury, Farrar said.”
  • Health Day lets us know,
    • “E-cigarettes could be reshaping the future of cancer in the United States, by offering people a less-toxic option than smoking, a new study argues.
    • :Smokers are increasingly switching to vaping and other forms of nicotine use, researchers reported July 27 in the journal JNCI Cancer Spectrum.
    • :They’re also sticking with their vapes, rather than swapping back and forth with tobacco cigarettes, researchers found.
    • “Our results show that exclusive cigarette use is being replaced by exclusive use of other combustible products, mainly e-cigarettes, especially among young adults,” said lead researcher Kenneth Michael Cummings, in a news release.”
  • and
    • “Work stress could be eating away at the sleep of most middle-aged working folks, undermining their health, a new study says.
    • “Nearly 70% of a small group of people ages 50 to 66 experienced persistent sleepproblems, even though they had no history of sleep disorders, researchers reported July 28 in the journal Scientific Reports.
    • “Even more concerning, more than 9 out of 10 (92%) of the participants met the clinical threshold for a sleep disorder at least once during the yearlong study, researchers said.
    • “I was genuinely surprised by the sheer scale of sleep problems we uncovered in this otherwise undiagnosed group,” lead researcher Athanasios Tsanas said in a news release. He is a professor of digital health and data science at the University of Edinburgh in the U.K.”
  • BioPharma Dive tells us,
    • “A Novo Nordisk heart drug missed the main goal of a Phase 3 trial, failing to show it prevented heart attacks, strokes or cardiovascular death in people with hardened arteries or chronic kidney disease, the company said Friday.
    • “Called ziltivekimab, the drug is part of a sprawling clinical program involving three late-stage trials that have collectively enrolled more than 20,000 people. Two others, in people with heart failure or who’ve had an acute heart attack, are ongoing. Results are expected next year. They all aim to show lowering levels of an inflammatory protein called IL-6 can can reduce the risk of heart-related complications and death.
    • “Novo gained control of ziltivekimab through a 2020 acquisition of Corvidia Therapeutics, for which it paid $725 million up front and promised up to $2.1 billion in total payouts. Novo said it will take a “non-cash impairment charge” in the third quarter but will not need to change its operating profit forecasts.” 

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

  • Fierce Healthcare reports,
    • “Cigna executives offered investors a look at the progress the company has made in the rollout of its new Signature pharmacy benefits model, which moves away from traditional drug rebates.
    • “CEO Brian Evanko said during the company’s earnings call that the team is “making strong progress in the build-out” of the model. It will roll out to Cigna Healthcare’s fully insured plans in 2027, before a wider launch in 2028.
    • ‘In particular, the model is designed around the affordability of brand-name drug products, and the company projects that it could save members 30% per month on branded medications. Through Signature, tech platforms will surface the lowest price to the member at the pharmacy counter, even if that’s a cash-pay option or provided by a manufacturer’s direct-to-consumer programs.
    • “We see significant early interest from health plans and employers as we prepare for our broader market launch in 2028,” Evanko said. “At the same time, we’re adding value and winning business today, with 2027 representing one of our strongest selling seasons in recent years.”
  • and
    • “Alignment Healthcare delivered a strong second quarter, in what CEO John Kao said was supported by the deployment of its new artificial intelligence-powered stratification model.
    • “This advancement improved our ability to predict which members are going to be hospitalized,” Kao said. “Our model now accurately and dynamically predicts the 10% of members who will account for nearly 70% of hospital admissions over the next 30 days.” 
    • “Kao said the on the company’s Thursday earnings call it plans to “reinvest a portion” of savings to areas that produce “tangible, measurable returns,” including market expansions, branding and “deepening AI capabilities.
    • “Beyond its potential to unlock efficiencies in our cost structure, AI represents a meaningful opportunity to further enhance our care model and support providers,” Kao said. “Most importantly, our approach to AI is grounded in decades of clinical expertise and reinforces our commitment to high-quality care. This is further supported by a governance framework to ensure responsible use, human accountability, and equitable treatment of our members.” 
  • Healthcare Dive relates,
    • “Siemens Healthineers has struck a 10-year deal to support diagnostic imaging, cardiology and radiation oncology at Cleveland Clinic, the company said Thursday.
    • “Building on its 35-year relationship with the academic medical center, Siemens Healthineers will provide diagnostic imaging and therapeutic technologies, including magnetic resonance imaging, computed tomography, radiation oncology, interventional radiology and X-ray.
    • “Siemens Healthineers is expanding an existing team dedicated to Cleveland Clinic, adding on-site technicians and training personnel to its current group of more than 30 people.”
  • Beckers Hospital Review points out,
    • “A total of 438 urban hospitals closed across the U.S. between 2000 and June 2026, according to data shared with Becker’s from New Haven, Conn.-based Yale University’s Health Care Affordability Lab.
    • “Between 2001 and 2023, the period for which both openings and closures are fully tracked, urban hospitals posted a net gain of 11 nationally, with 396 openings and 385 closures. However, there were significant losses in individual states. New York lost a net 33 urban hospitals over that period, California lost 29 and Pennsylvania lost 24.
    • “The data covers general, short-term acute-care hospitals and excludes specialty facilities such as psychiatric, rehabilitation, children’s and VA hospitals. Urban and rural classifications follow the census-tract-level definition from the Health Resources & Services Administration’s Federal Office of Rural Health Policy.
    • “The tables [found in the article] show urban hospital net change by state from 2001 to 2023 and total urban closures by state from 2000 through June 2026. States with no urban hospital activity in the Yale dataset are not listed.
  • Fierce Pharma informs us,
    • “The small inflection point we noticed two weeks ago regarding Eli Lilly’s Foundayo does not appear to be a flash in the pan. Weekly total prescriptions for the small molecule reached 29,388, a new high for the oral GLP-1 receptor agonist after three weeks of consecutive growth, according to IQVIA data cited by Citi. 
    • “As IQVIA may be missing some scripts from telehealth channels, we will get a clearer picture of Foundayo’s launch progress when Lilly reports its second-quarter earnings on Wednesday, Aug. 5. Analysts at Jefferies have been modeling $71 million in U.S. sales for the quarter based on IQVIA data.
    • “Meanwhile, Novo Nordisk’s Wegovy pill remains far ahead in the oral GLP-1 race with total scripts also hitting a new record of about 171,700, according to Citi. The number represents 1.1% growth from its previous best recorded during the prior week.
    • “Coincidentally, the entire GLP-1 class also saw its total scripts grow 1.1% sequentially across diabetes and obesity uses. Lilly’s Zepbound regained some lost ground with total scripts up 1.9% week over week. That’s compared to Wegovy, which now makes up 40.6% of the obesity market after a 0.2% sequential decline in total scripts.” 
  • Per Fierce Healthcare,
    • “WellSpan Health inked an expanded multi-year partnership with artificial intelligence company Hippocratic AI, which expands AI-powered capacity across the network.
    • “Through the update, Hippocratic AI’s generative AI agent—Ana—will expand from handling inbound calls and primary care appointment scheduling to post-discharge follow-up and chronic disease check-ins.
    • “Initial workflows will focus on closing care gaps through outreach to patients with missed imaging appointments, executives say. Every new use of the AI agent will follow governance, safety and implementation structures in coordination with WellSpan teams.
    • “WellSpan Health CEO Roxanna Gapstur, Ph.D, said in a statement the future of the industry will “be shaped by the organizations that build the culture, governance and clinical capabilities” to utilize AI responsibly at scale.
    • “At WellSpan, we’ve been intentional about creating this foundation, so innovation advances safely, strengthens clinical excellence and earns trust,” Gapstur said. “Our expanded partnership with Hippocratic AI is an investment in the future of care — one that expands access, supports our care teams and creates a more personalized experience for every patient we serve.”

Midweek report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Per Centers for Medicare and Medicaid Services fact sheets
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update Medicare payment policies and rates for Inpatient Psychiatric Facilities (IPFs) under the IPF Prospective Payment System (PPS) (CMS-1847-F) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with its statutory authority to update Medicare payment policies for IPFs annually. 
    • “This fact sheet discusses the provisions of the final rule, including annual updates to the prospective payment rates, the outlier threshold, the wage index, and associated impact analysis. In addition, the rule finalizes a policy effective for FY 2028 (October 1, 2027) to limit outlier payments at the facility level to no more than 20% of an IPF’s total IPF PPS payments in a year, for IPFs with at least 50 stays per year. For the IPF Quality Reporting Program, CMS is removing two measures from the program, as well as implementing a standardized IPF patient assessment instrument.
    • “For FY 2027, CMS is updating the IPF PPS payment rates by 2.3%, based on the 2021-based IPF market basket increase of 3.2% less a 0.9 percentage point productivity adjustment. Additionally, CMS is updating the outlier threshold so that estimated outlier payments remain at 2% of total IPF PPS payments. Total estimated payments to IPFs would increase by 2.3%, or $60 million, in FY 2027, relative to IPF payments in FY 2026.”
  • and 
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule for updates to Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with the legal requirements to update Medicare payment policies for SNFs annually. This fact sheet discusses the final rule’s provisions.
    • “For FY 2027, CMS finalized updating SNF PPS rates by 2.4% based on the final SNF market basket of 3.3%, reduced by a 0.9% productivity adjustment, for an estimated increase of $882.74 million in aggregate payments to SNFs.”
  • Beckers Hospital Review points out twelve things to know about these rules.
  • The American Hospital Association News relates,
    • “The Health and Human Services Secretary today announced that dozens of insurers, medical societies, healthcare providers and behavioral health experts have pledged to strengthen the nation’s behavioral health system by advancing best practices aimed at improving mental health and addiction treatment. The pledge commits participants to promoting timely access, improving quality measurement and accountability, supporting patient-centered recovery services and expanding whole-person treatment that addresses behavioral and physical health needs. HHS said the initiative aligns with the administration’s broader efforts to address addiction and mental illness and improve long-term patient outcomes.” 
  • Federal News Network clears up common misconceptions about federal retirement benefits.
    • “Misconception: Federal Employee Health Benefits (FEHB) go away at retirement, or become more expensive.
    • “Fact: Under certain eligibility requirements, federal employees can continue their FEHB coverage into retirement. These requirements include enrollment in FEHB for at least five consecutive years leading up to, and having coverage on, the retirement date. It is important to note that qualified spouses, dependent children, and children with disabilities can be covered without meeting this five-year rule. Employees become classified as annuitants upon retiring, at which point the government will continue to cover about 72% of the FEHB premium.
    • In addition, retirees can also enroll in Medicare parts A and B, offering nearly comprehensive coverage, with Medicare as the primary payer and FEHB as secondary. To reduce costs, some retirees opt for a basic FEHB plan.”
    • “Misconception: Spouses will automatically continue to be covered by FEHB into retirement
    • “Fact: This is the biggest caveat about survivor’s benefits: If survivors were on the federal retiree’s health insurance plan, that health insurance will cease if there is no survivor’s benefit. Any amount of survivor’s benefit will continue the health insurance plan, so prospective retirees and their spouses should speak with a federal retirement consultant, and consider the holistic picture of their assets, the spouse’s income, their needs and budget, life insurance, and whether they have any additional financial obligations, like debt or a child in college.”
    • “Misconception: Survivor’s benefits are automatic and free
    • “Fact: Federal employees will need to make some decisions about survivor’s benefits on their retirement application. The pension is the main place where retirees need to consider their options along with their potential beneficiaries — these will primarily be spouses, except in a few special circumstances. Each of these options comes with a cost, in the form of a monthly percentage deducted from the overall pension. The options and percentages vary between the Federal Employees Retirement System and the Civil Service Retirement System.”
  • Beckers Hospital Review tells us,
    • “Federal policy changes could reshape pharmacy reimbursement, drug pricing and hospital operations in 2027, according to a new Vizient outlook. The report, published July 27, highlights four pharmacy developments health systems should monitor as they plan for the year ahead.
    • “The four policy developments:
      • “340B outpatient drug reimbursement: CMS has proposed reducing reimbursement for 340B-acquired drugs from average sales price plus 6% to ASP-33.4%. 
      • “340B remedy offset: CMS has proposed increasing the offset from -0.5% to -3%, a change the agency estimates would reduce payments by $2.3 billion in 2027.
      • “Section 232 tariffs: New pharmaceutical tariffs and ongoing investigations into medical devices could affect supply chains and costs.
      • “Medicare Drug Price Negotiation Program: CMS has issued draft guidance for implementing negotiated prices in 2028, including drugs covered under Medicare Parts B and D.

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.
    • “Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”
    • “Ezplaz is a freeze-dried (lyophilized) plasma product derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. It is available in Group AB and Group A with low-titer anti-B blood types, chosen to mitigate risk of giving to patients in emergencies before their blood type is determined.”
  • Contemporary OB/GYN relates,
    • “On July 29, 2026, the FDA approved norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo; Viatris Inc.) as a once-weekly combined hormonal contraceptive (CHC) patch with a low dose of estrogen for women of childbearing potential with a body mass index (BMI) below 30 kg/m², the company announced in a news release.1
    • “The approval was granted under the FDA’s 505(b)(2) regulatory pathway and was supported by results from the phase 3 Luminous Study (NCT05139121).2 Norelgestromin and ethinyl estradiol delivers norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day over each 7-day wear interval. The patch, which is reversible and non-invasive, is applied once weekly for 3 consecutive weeks, followed by 1 patch-free week.” * * *
    • “Viatris expects norelgestromin and ethinyl estradiol to be commercially available later in 2026.”
  • and
    • “Natural Cycles has received its sixth FDA clearance, this time for an updated version of the algorithm underlying its FDA-cleared birth control app. The company described the update as combining statistical modeling with machine learning trained on real-world fertility data to generate more individualized fertility predictions for users, according to a news release published July 27, 2026.”
  • Cancer Network tells us,
    • “The FDA has granted fast track designation to ISM6331, an AI-designed pan-TEAD inhibitor, for the treatment of adult patients with unresectable malignant pleural mesothelioma whose disease has progressed on or after prior anti–PD-1 antibody therapy, with or without anti–CTLA-4 antibody therapy, and platinum-based chemotherapy, according to a news release from the developer, Insilico Medicine.”
  • Cardiovascular Business points out,
    • “The U.S. Food and Drug Administration (FDA) has granted de novo market clearance for the first and only biomarker technology to directly see and quantity coronary inflammation from routine coronary CT angiography (CCTA). 
    • “The CaRi-Heart technology from Caristo Diagnostics has been heralded by numerous cardiac CT experts as a potential paradigm shift in cardiology. It is the first technology that can visualize and clearly quantify coronary inflammation using fat attenuation index (FAI) scores. This helps care teams estimate the residual risk of heart attacks in patients who otherwise appear to be managed well on optimal medical therapy.
    • “We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” Ron Blankstein, MD, director of cardiac CT at Brigham and Women’s and a former Society of Cardiovascular Computed Tomography (SCCT) president, said in a statement. “And now for the first time, clinicians can specifically measure coronary inflammation, obtaining a more complete picture of cardiovascular risk compared to standard CCTA, or calcium scoring alone. It is exciting to see Caristo’s long-awaited, pioneering solution available in the U.S.”
  • STAT News informs us.
    • “A group of outside experts convened Wednesday by the Food and Drug Administration concluded clinical data for a treatment for Duchenne muscular dystrophy from Capricor Therapeutics did not provide “substantial evidence” of efficacy.  
    • “The vote was 9-3, sending to the FDA a recommendation that the Capricor treatment, called deramiocel, should not be approved. 
    • “The FDA is not required to adhere to the expert panel’s stance, but it typically does. The agency review is still underway with a decision expected by Aug. 22. 
    • “The negative vote came at the end of an all-day meeting during which disputed results from a Phase 3 clinical trial were discussed and debated. Capricor’s presentation highlighted an analysis showing deramiocel preserved upper-arm function and staved off the heart failure most patients with Duchenne eventually experience.
    • “The FDA countered with a critique of the data that reached opposite conclusions — deramiocel was unable to separate from placebo at all. The agency also spent a good deal of time during Wednesday’s meeting calling out Capricor, saying it made major changes to the study’s statistical analysis plan that degraded the robustness of the data and made even seemingly positive outcomes hard to interpret.” 
  • Beckers Hospital Review notes,
    • “The FDA has published 17 revised draft product-specific guidances for peptide products, updating its recommendations for the development and assessment of certain generic peptide drugs.” * * *
    • “The FDA said the updates provide recommendations in five areas: submission of recombinantly, synthetically or semi-synthetically produced peptides as abbreviated new drug applications, innate immune response testing, impurity thresholds, higher order structure assessment and biological activity assessment.
    • “The FDA also said it is withdrawing its May 2021 guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, because it no longer reflects the agency’s current scientific thinking. The Center for Drug Evaluation and Research plans to revise that guidance this year.”

From the public health and medical / Rx research front

  • The Washington Post reports,
    • “About 12,000 pounds of smoked bacon imported from Canada were recalled because of lack of proper reinspection before entering the country, the Agriculture Department’s Food Safety and Inspection Service said.
    • “The bacon from Maple Leaf Foods was shipped to grocery distributors and retailers in Idaho, Oregon and Washington state. FSIS inspects imported products for packaging, documentation, condition and contamination.” * * *
    • “There are currently no confirmed cases of illness or injuries due to the products, FSIS said.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention yesterday reported 18,207 confirmed or suspected cases of cyclosporiasis across the U.S. from the current outbreak. The agency said it is investigating multiple case clusters, including an outbreak impacting nine states that is linked to iceberg lettuce. A July 17 Food and Drug Administration notice said that Taylor Farms recalled iceberg lettuce sourced from central Mexico that was distributed to 27 states, due to the potential of being contaminated with cyclospora.” 
  • The New York Times lets us know about “Nine Things Experts Wish You’d Do in Midlife to Increase Longevity.”
    • “How you treat your body and brain in your midlife years, loosely defined as 40 to 60, can hugely influence how you age in the decades to come.
    • “The seeds for many age-related diseases, including cardiovascular disease, diabetes, cancer and dementia, are sown in middle age, so it’s important to start thinking about prevention early. And it takes a lifetime of healthy habits, not just a few weeks, to move the needle on your longevity.
    • “Midlife is the ideal time to make changes, not only to benefit you in the present, but also in the future,” said Margie Lachman, a psychology professor at Brandeis University and the author of “Primetime: A New Vision for Midlife.”
    • “After all, she added, “What happens in midlife doesn’t stay in midlife.”
    • “We spoke with experts about some small habits that can make a big difference.”
  • Health Day tells us,
    • “Childhood obesity can be effectively treated through a family-based program provided through their local pediatrician, a new clinical trial says.
    • “About 42% of kids in the program lost enough weight to improve their heart health and lower their diabetes risk within a year and a half, researchers reported July 27 in JAMA Pediatrics.
    • “The program teaches families how to establish healthy eating and exercise habits, including positive reinforcement and supportive routines, researchers said.
    • “Our results show that an established, effective obesity treatment for children and adolescents can be successfully delivered in their pediatrician’s office,” lead researcher Amanda Staiano said in a news release. She is director of the Pediatric Obesity and Health Behavior Laboratory at Pennington Biomedical Research Center at Louisiana State University.”
  • Drug Topics informs us,
    • “Alcohol use, binge drinking, and heavy drinking have all increased significantly among pregnant women in the US from 2011 to 2024, according to a JAMA study. Likewise, with no end in sight for the trends in their findings, study authors consider them “concerning,” highlighting the need to address the growing trends among expecting mothers and their alcohol consumption.
    • “It is well established that alcohol is a teratogen, and numerous existing guidelines advise women to abstain from alcohol during pregnancy and while breastfeeding,” wrote the authors of a study in Drug and Alcohol Review. “However, many women consume alcohol in pregnancy even after learning they are pregnant. Worldwide, approximately 10% of women in the general population consume alcohol in pregnancy, although the European region has the highest rate of consumption (25%).
    • “The JAMA analysis revealed that from 2011 to 2024, the relative increase in current alcohol use among pregnant individuals reached 59%, and binge drinking rose by 77% and heavy drinking surged by a startling 166%. These absolute increases, 5.4%, 2%, and 1.2%, respectively, represent a significant shift in behavior that researchers indicate has no clear sign of reversal.”
  • Genetic Engineering and BioTechnology New lets us know,
    • “Engineers and neuroscientists at the University of California (UC) San Diego have developed a soft, wearable fingertip patch that continuously tracks a Parkinson’s disease (PD) patient’s levodopa medication levels by measuring chemicals in their sweat, with no batteries required. Tests in healthy volunteers and in Parkinson’s disease patients showed that measurements generated using the device were comparable to those obtained by standard laboratory blood tests.
    • “The wearable device offers a way to continuously track real-time concentrations of levodopa in the body and could enable doctors to precisely customize daily medication schedules for patients at home.
    • “The research was led by Tamoghna Saha, PhD, a postdoctoral researcher in the lab of Joseph Wang, DSc, professor in the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering at the UC San Diego Jacobs School of Engineering. Saha is co-first author of the team’s published paper in PNAS titled “A wearable patch for continuous levodopa monitoring in sweat: Towards exertion and power-free pharmacodynamic assessment in Parkinson’s disease.” In their paper the authors wrote in summary, “Overall, our easy-to-use, energy-efficient wearable supports real-time, stimulation-free monitoring, potentially enabling at-home dosage adjustments and paving the way for future autonomous closed-loop L-dopa therapeutic system development.”
  • Per an Institute for 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 tavapadon (AbbVie Inc.) for Parkinson’s Disease.
    • “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.
    • “On August 5, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.”
  • Per STAT News,
    • “For decades, efforts to develop non-opioid pain drugs were marked by failure. But what was once a graveyard of drug discovery is quickly turning into a race for a multibillion-dollar market, with Latigo Biotherapeutics publishing positive data on Wednesday for a therapy meant to rival a Vertex medicine already on the market.
    • “The startup’s Phase 2 trial enrolled 343 patients who’d gotten tummy tuck surgery; they were randomized to receive a high or low dose of Latigo’s experimental pill, a placebo, or a combination of acetaminophen and the opioid hydrocodone. Those given either dose of Latigo’s oral drug, LTG-001, showed statistically significant pain relief compared to placebo after 48 hours. And while participants in all groups had the option to use the opioid oxycodone if they needed additional pain management, those on a high dose of Latigo’s therapy were significantly less likely to do so than participants on placebo.” * * *
    • “The biotech plans to start a Phase 3 study later this year of patients who’ve had bunion removal surgery, with results expected in the second half of 2027.”

From the U.S. healthcare business and articifical intelligence fronts,

  • Beckers Payer Issues reports,
    • “Humana reported a $694 million profit for the second quarter, up more than 27% year over year, according to its July 29 earnings report.
    • “Revenue reached $40.8 billion, a 26% increase from the same period in 2025, driven by Medicare membership growth, higher per-member Medicare Advantage and standalone prescription drug plan premiums from increases in benchmark funding and the Part D direct subsidy, and a payer-agnostic CenterWell client base. Star ratings headwinds persisted.
    • “Total Medicare membership reached 11.1 million, up from 8.2 million in the comparable quarter. Total medical membership was 17.9 million, an increase from 14.8 million.
    • “The company’s benefit ratio was 91.1%, up from 89.7% in the second quarter of 2025, spurred by the star ratings revenue issue, new individual MA members with higher benefit ratios and an expectation of lower favorable prior period development. However, MA recontracting, pricing and clinical excellence efforts offset that growth.”
  • Beckers Hospital Review notes,
    • “Jaewon Ryu, MD, the founding CEO of Risant Health, will step down, and Dale Maxwell has been named interim CEO.
    • “According to a July 29 news release, Dr. Ryu made the decision to leave the role to focus on his family. Mr. Maxwell, former president and CEO of Albuquerque, N.M.-based Presbyterian Healthcare Services, will serve as interim CEO while the Risant Health board conducts a national search for a permanent successor.
    • “Washington, D.C.-based Risant Health is a nonprofit created by Oakland, Calif.-based Kaiser Permanente to expand value-based care by partnering with community health systems. As the organization’s inaugural CEO, Dr. Ryu built its leadership team and operating model and oversaw the additions of Danville, Pa.-based Geisinger, which operates 10 hospital campuses, and Greensboro, N.C.-based Cone Health, which has five hospitals and more than 150 locations.
    • “Jaewon has been instrumental in turning the vision for Risant Health into reality,” Greg Adams, chair and CEO of Kaiser Permanente and chair of the Risant Health board, said in the release. Mr. Adams said Dr. Ryu built an exceptional leadership team and positioned the organization to expand value-based care.”
  • Fierce Healthcare relates,
    • “AI doctor startup Doctronic aims to broaden its reach beyond adult primary care by acquiring text-based pediatric care platform Summer Health.
    • “The companies did not disclose the financial terms of the deal.
    • “Fast-growing Doctronic is an AI-native primary care provider that has supported 30 million health encounters in just two years. It offers a proprietary AI doctor and nationwide network of licensed clinicians delivering personalized medical guidance and video visits for $39, according to the company.
    • “The startup offers a free personal AI doctor via chatbot to help navigate symptoms and answer medical questions and can connect users with a licensed physician through a virtual visit. Doctronic, available in all 50 states, is being tested by the state of Utah to refill prescriptions as part of a pilot program.”
  • and
    • “Hospitals should plan for their supply chain expenses to climb in 2027, with the prices for indirect spending categories like IT, construction and even food projected to grow at an even faster rate than those for drugs, Vizient warned in its most recent forecast report. 
    • “Vizient’s latest twice-yearly report mapped out overall supply chain price inflation of 3.39% for 2027, an increase of 0.61 percentage points compared to the forecast it released in February for the 12-month period beginning in H2 2026. 
    • “The primary culprits, Vizient research and intelligence director Jeff King told Fierce Healthcare, are AI demand and elevated costs of logistics and energy that are being felt across the world.”
  • and
    • “Alongside an update to its 2026 ratings, national nonprofit Leapfrog Group announced Monday the launch of an expanded ambulatory service center (ASC) reporting program. The expanded Leapfrog ASC Public Reporting Program, first unveiled in April, reports safety and quality information for facilities nationwide. More than 3,900 ASCs are now included in the 2026 ratings, along with more than 2,400 hospitals—which the nonprofit says is the highest level of participation in its 26-year history.”
  • Fierce Pharma points out,
    • “With increased sales of its newer drugs compensating for declining revenues from its multiple sclerosis (MS) portfolio, Biogen is once again positioned for a “growth story,” CEO Chris Viehbacher said Wednesday during the company’s second-quarter earnings call.
    • “To that end, Biogen reported revenue of $2.74 billion for the period, marking its highest quarterly haul since Q3 of 2021. With the result, the company flipped its 2026 revenue guidance from an expected mid-single digit decline in 2026 to a mid-single digit increase.  
    • “This quarter is a reflection of the significant progress Biogen has made repositioning the company for long-term growth,” Viehbacher added.
  • Beckers Hospital Review tells us what 17 pharmacy leaders think about “the biggest shifts they’re seeing in patient expectations.”
  • MedCity News informs us,
    • “For many people, managing a disease means chronic therapy. Scribe Therapeutics has a different vision: genetic medicines that offer durable effects for the masses. With its lead program on a path to report its first human data next year, Scribe has joined the public markets, raising $128.7 million. 
    • “While current genetic medicines are largely limited to rare disorders, we are engineering our technologies for use in common diseases affecting millions,” Scribe said in its IPO filing. “By targeting prevalent diseases with significant unmet need and high clinical burden, we aim to usher in a new era of broadly scalable, transformative, and preventative genetic medicines.”
    • * * * “Alameda, California-based Scribe has selected cardiometabolic disorders as its first focus. Lead therapeutic candidate STX-1150 is intended to lower the “bad” form of cholesterol, which is a risk factor for atherosclerotic cardiovascular disease (ASCVD). This therapy is designed to lower LDL-cholesterol by repressing expression of PCSK9, a protein that in high amounts, reduces the ability of the liver to clear cholesterol from the blood. Injectable PCSK9 inhibitors are already available from Amgen, Regeneron Pharmaceuticals, and Novartis. Last week, Merck received FDA approval for Lipfendra, an oral PCSK9 inhibitor. While dosing frequency for these therapies varies, all of them are taken chronically.”
  • STAT News reports,
    • “Hundreds of thousands of U.S. doctors use clinical large language models, pitched by companies like OpenEvidence, Doximity, and UpToDate as an antidote to the dangers of hallucination-prone generalist models from Big Tech. Yet few studies have pitted them against each other — and this summer brought a high-profile head-to-head. 
    • “Researchers from NYU Langone Health had tested general and clinical models, including OpenEvidence and UpToDate Expert AI, on three sets of clinical questions. The findings, published in Nature Medicine in June: The clinical AI performed worse than the general models. 
    • “The results rang out like a gunshot. “I’ve never seen a single paper trigger the kind of reactions this one has in the health AI community,” wrote Kaiser Permanente’s vice president of AI and emerging technologies on LinkedIn. The paper’s findings, like all science, are subject to interpretation and debate — but many online reactions treated them more like a clear victory for general frontier models.” * * *
    • “Scientists acknowledge that no one test will ever tell the whole story about clinical AI performance. And day-to-day, the choice of when and how to use large language models in care — by individual doctors, and increasingly health system leaders — is shaped by more than research.
    • “I don’t see the benchmarks really playing a role among doctors,” said OpenEvidence’s Nadler. “Academics like talking about them.” 
    • “The more important question, companies, doctors, and researchers agree, is how these tools impact patients. 
    • “Anytime a new technology is introduced into medicine, its impact on those outcomes depends on how it’s used by physicians. Are they using the tool safely and correctly, on the right patients, in the right situations?
    • “In the case of AI, that often comes down to trust. An accurate model inspires confidence, but it can still occasionally be wrong — potentially leading a physician astray, if they rely on it outright. Conversely, a good model can leave gains on the table if a physician doesn’t trust its output.” 


Tuesday report

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

Simplicity is a virtue.

From Washington, DC

  • Per a Centers for Medicare and Medicaid Service news release,
    • “On July 28, 2026, the Centers for Medicare & Medicaid Services (CMS) released preliminary technical Medicare Part D bid information for contract year (CY) 2027 to help Part D plan sponsors finalize their Part D and Medicare Advantage (MA) offerings and prepare for Medicare Open Enrollment. 
    • “Additionally, CMS is announcing the conclusion of the Part D Premium Stabilization Demonstration, a voluntary demonstration for standalone prescription drug plans implemented in CY 2025 to address volatility and variation in standalone premiums following benefit changes mandated by the Inflation Reduction Act (IRA). For CY 2027, CMS bid analysis indicates that Part D plan sponsors had sufficient experience under the redesigned Part D benefit to support their assumptions in developing the prescription drug plan bids. Therefore, CMS will discontinue the demonstration at the end of CY 2026 to return the program to operating under traditional market conditions in CY 2027. 
    • “As in past years, CMS will release the 2027 MA and Part D landscape in mid-to-late September, once all offerings are finalized. In addition, CMS will release final average MA and Part D premiums, along with other key information, in September with the MA and Part D landscape.” 
  • The Wall Street Journal adds,
    • “The average premium for a Part D plan was around $36 a month this year, according to KFF, a health-policy nonprofit. 
    • “The administration official said around 25% of Medicare Part D plan enrollees would see premiums for their plans stay flat or go down next year. Around 30% will have an increase of less than $10 to their monthly bill. 
    • “For the remaining 45%, he said, the increases are largely in the $11 to $20 range a month. 
    • “Seniors should be able to find lower premiums if they switch plans, he said, adding affordable options are still available.
    • “Medicare drug coverage premiums are rising because the plans have been hit by growing expenses for GLP-1 medications and other specialty drugs. Changes implemented under 2022’s Inflation Reduction Act also have pushed up premiums. The law reduced many Medicare enrollees’ out-of-pocket expenses but required insurers to shoulder more of the costs. 
    • “Those pressures are expected to continue in 2027, said Juliette Cubanski, a vice president at KFF.” 
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services July 27 released its Contract Year 2025 Part C and Part D Program Audit and Enforcement Report, outlining key compliance issues identified through Medicare Advantage and Part D audits and enforcement activities. CMS emphasized recurring problems involving prior authorization and appeals processing, beneficiary access to medications and services, care coordination, enrollment and eligibility errors, and oversight of delegated entities. The report also highlights enforcement actions totaling approximately $1.54 million in civil money penalties, most of which stemmed from beneficiary cost-sharing and payment integrity failures. CMS signaled increased scrutiny of plans’ compliance with new prior authorization requirements, including the requirement beginning this year to process expedited requests within 72 hours and standard requests within seven calendar days.” 
  • A CMS news release adds,
    • “The Centers for Medicare & Medicaid Services (CMS) announced that enforcement efforts from its Medicaid Fraud War Room (MFWR) stopped more than $203 million in potentially improper Medicaid payments in just under 90 days, highlighting significant progress in protecting taxpayer dollars and strengthening Medicaid program integrity. Since its launch on April 23, the MFWR has coordinated actions against 50 unique, high-risk Medicaid providers identified through advanced data analytics and representing more than $203 million in Medicaid payments subject to federal exclusions and state enforcement efforts.
    • “Every dollar lost to Medicaid fraud is a dollar taken away from vulnerable Americans who rely on it,” said CMS Administrator Dr. Mehmet Oz. “In just under 90 days, the Medicaid Fraud War Room has proved that these losses aren’t inevitable and has shown Americans what we can accomplish with robust federal-state partnerships, advanced data analytics, and a real sense of urgency. We’ve made significant progress toward crushing waste, fraud, and abuse, but we’re not done yet. If you steal from Medicaid, we will track you down, cut you off, and work to ensure that every taxpayer dollar we spend funds quality care for eligible beneficiaries.”
  • The American Hospital Association News further tells us,
    • “An AHA blog published July 28 highlights new electronic prior authorization requirements that begin Jan. 1, 2027, as a result of the Centers for Medicare & Medicaid Services’ 2024 Interoperability and Prior Authorization final rule. The blog explains why transitioning to the new process will be a significant operational change that will include coordination with health plans, electronic health record vendors and other technology partners. READ MORE“
  • Per a CMS notice to be published tomorrow in the Federal Register,
    • In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Office of Personnel Management, “ Verification of Eligibility for Minimum Essential Coverage Under the
    • Patient Protection and Affordable Care Act through an Office of Personnel Management Health Benefit Plan”. The matching program provides CMS and State Administering Entities with the Office of Personnel Management (OPM) data to use in determining individuals’ eligibility to enroll in a qualified health plan through an exchange established under the ACA; for insurance affordability programs, certifications of exemption, and to make eligibility redeterminations and renewals, including appeal determinations.

From the Food and Drug Administration front,

  • The New York Times reports,
    • “Even as the number of cyclospora cases in the United States hit record levels, top health regulators insisted that consumers could still trust what they were eating.
    • “The U.S. food supply is safe,” Donald Prater, the acting deputy commissioner for food at the U.S. Food and Drug Administration, told attendees Monday at the annual meeting of the International Association for Food Protection.
    • “However, there’s a couple of challenges,” he said, referring to the cyclosporiasis outbreaks that have sickened more than 11,000 people across the country. “It will take a little time. But we do believe we’re taking action and we’re protecting public health.”
  • The Hill adds,
    • “A poll released Sunday shows that 40 percent of U.S. adults are buying or eating less produce after the cyclospora outbreak. 
    • “Comparatively, according to survey results from CBS/YouGov, 4 percent of people said they are eating more produce. 
    • “Among respondents, 56 percent said there has been no change in their diet.” 
  • Fierce Pharma relates,
    • “The FDA has signed off on MannKind’s Furoscix ReadyFlow (furosemide) autoinjector for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD).
    • “Furoscix ReadyFlow becomes the first at-home treatment option to reduce the fluid buildup from HF or CKD. The drug-device combo has been designed to help patients address edema earlier, before symptoms worsen and lead to potential emergency department visits or hospitalization. It has been shown to work as effectively as an intravenous diuretic, which is usually administered in a clinic or hospital.
    • “Furoscix ReadyFlow is taken under the skin in less than 10 seconds, significantly reducing the administration time from five hours with MannKind’s currently available on-body infusor. The company expects to make Furoscix available in the U.S. by the end of August.”
  • The ASCO Post informs us,
    • “The FDA’s Oncology Center of Excellence announced three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs.  
    • “Fewer than 5% of patients with cancer currently receiving treatment are enrolled in clinical trials—even though more than 70% say they are willing to participate. The guidance documents address one reason for low participation: stringent and complex clinical trial eligibility criteria. 
    • “Unnecessarily restrictive eligibility criteria may slow subject accrual, limit patients’ access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug,” the three guidances say in their preambles.”  
  • The American Hospital Association News points out,
    • “Baxter is voluntarily recalling a specific lot of intravenous solution due to a report of particulate matter in the solution identified as cardboard, according to a Food and Drug Administration notice. The company is recalling lot LD175708 of its Cefazolin in Dextrose Injection with an expiration date of Feb. 14, 2027. Baxter said use of the product can potentially cause pulmonary embolism, among other harmful impacts. The company said that customers should immediately discontinue use of the solution and return all affected products. Baxter has not received any reports of adverse events related to the issue.” 
  • Cardiovascular Business adds,
    • “Medtronic is recalling specific lots of six different medical devices used as arterial cannulae during cardiopulmonary bypass procedures. This includes multiple models of the company’s 22FR EOPA 3D Arterial Cannulae and its 22FR EOPA Elongated One-Piece Arterial Cannulae.  
    • “Medtronic initiated the new recall after receiving more than 30 reports of small pinhole leaks in the wire-wound body of the devices. These leaks can be difficult to identify during routine inspection; they are primarily visible when the cannula is in a flexed position. 
    • “Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia and organ dysfunction,” according to an alert shared with customers.” 

No Surprises Act News,

  • Elevance Health, writing in STAT News, reports
    • The [Elevance Health] analysis [of No Surprises Act arbitrations] examined more than 7,300 disputed claim lines involving spine surgery, plastic surgery, colonoscopies, hysteroscopies, and other planned procedures resolved between 2024 and early 2026. Across the procedures studied, providers prevailed in nearly 90% of disputes, and the average award approached $40,000 per disputed claim line.
    • The arbitration awards were also found to be drastically higher than commonly used payment benchmarks. Across the planned procedures analyzed, the median award was more than 50 times the qualifying payment amount, which is the benchmark based on an insurer’s median in-network contracted rate. Worse still, the median arbitration award was 29 times higher than median in-network commercial claims, and 67 times higher than Medicare rates for the same procedures in the same locations. Awards for assistant surgeons were even more extreme, with the median award more than 145 times the qualifying payment amount.
    • Researchers also found that awards for these planned procedures increased over time. Between 2024 and 2025, arbitration awards for the procedures analyzed rose by 43%.
    • Although these disputes represented a relatively small share of overall IDR volume, they accounted for a disproportionate share of arbitration costs because of the size of the awards. Planned surgical procedures and associated neuromonitoring represented roughly 16% of disputes but approximately 60% of No Surprises Act arbitration costs.” * * *
    • “The findings do not describe all No Surprises Act disputes. They focus on a defined subset of planned procedures and associated services. But they point to a broader implementation question: whether some categories of scheduled services are entering IDR in ways that could increase costs.
    • “The study identifies several policy considerations for policymakers to evaluate, including strengthening eligibility standards for planned procedures entering IDR, increasing transparency around arbitration decisions, reinforcing the use of market-based payment benchmarks, and providing additional guidance for arbitrators evaluating payment disputes.”
  • FEHBlog observation: Amen to that. Those changes would lower healthcare costs.

From the public health and medical / Rx research front

  • The New York Times reports,
    • “Kira Wynn will do almost anything to avoid ovarian cancer, which killed her mother.”
    • * * * “So Ms. Wynn, 37, had a consultation with Dr. Rebecca Stone, a gynecological oncologist at Johns Hopkins Medicine. What she heard was not what she expected.
    • “Ovarian cancer,” Dr. Stone told her, is a misnomer. Nearly all ovarian cancers — and nearly all fatal ovarian cancers — are actually cancers of the fallopian tubes. The 20 percent or so that start in the ovaries are different, Dr. Stone said, and usually can be cured.
    • “Women who have their tubes — the gummy worm-shaped ducts that carry eggs from the ovaries to the uterus — removed reduce their chances of getting ovarian cancer by nearly 80 percent. It’s a five-minute operation that can be done as part of nearly any abdominal surgery, including a hysterectomy, tubal ligation, gallbladder surgery and hernia repair.
    • “Yet no doctor, Ms. Wynn said, had ever mentioned fallopian tube removal to her.
    • “That’s not surprising, Dr. Stone said, because most doctors (and the public) do not know about this new approach, even though professional groups like the American Cancer Society, the American College of Surgeons and the European Society of Gynaecological Oncology have recently issued statements encouraging doctors to offer tube removal at the time of other abdominal surgeries.”
  • The American Hospital Association relates,
    • “The American Red Cross July 27 declared a national blood supply crisis, as the organization said that blood donations have fallen to a four-year summer low. The organization said that it has less than a one-day national supply of type O positive blood and is limiting distribution of type O blood to hospitals. This year is the second time in its history that the Red Cross declared a national blood crisis, the first since January 2022.” 
  • The Washington Post adds,
    • “The American Red Cross has less than a one-day national supply of O-positive blood, the most commonly transfused blood type, and has begun limiting distributions of the blood to hospitals, it said.
    • “The only previous national blood crisis declared by the group came in 2022 as a surge of covid-19 cases lowered blood donor turnout.
    • “The American Red Cross urged all eligible donors to make appointments to give blood.”
  • Health Day tells us,
    • “Middle-aged folks have a higher risk of muscle loss if their weight “yo-yos” due to inconsistent dieting, a new study says.
    • “People who repeatedly dropped and regained weight wound up losing nearly four times as much thigh muscle during a four-year period compared to others whose weight remained relatively steady, researchers recently reported in the journal Radiology.
    • “When people’s weight cycled, they lost tremendous amounts of muscle along with the fat, and they didn’t gain the muscle back,” said lead researcher Dr. Thomas Link, a professor of radiology at the University of California-San Francisco.
    • “This tells us that understanding how to protect muscle while people are losing weight is important for overall health,” he said in a news release.”
  • The Washington Post adds,
    • “Savings to the overall health care economy from GLP-1 drugs have yet to be proven, but researchers have found evidence that health benefits could spill into the labor market.
    • “A study of workers in Denmark showed a 17.3 percent decline in long-term sick leave among those who were treated with Ozempic, the diabetes drug, according to results published this month in a National Bureau of Economic Research working paper. The researchers were from the University of Copenhagen, the University of Chicago, Duke University and the Rockwool Foundation — an independent organization that conducts research on social and economic issues.
    • “Before treatment, the study noted, an average of 5.5 percent of the workers accessed long-term sick leave (defined as longer than 30 days). That dropped nearly a full percentage point after treatment with the drug, the research found. About 84 percent of the patients in the study, which was conducted through analysis of health records and has not been peer-reviewed, had diabetes.”
  • MedPage Today points out,
    • “Nongated chest CT scans are usually performed for reasons other than to assess cardiovascular risk.
    • “Incidental coronary artery calcium (CAC) scores extracted from nongated chest CT scans accurately predicted cardiovascular risks in a community-based cohort.
    • “Patients with moderate or severe nongated CAC had significantly higher risks of cardiovascular disease and coronary heart disease versus those with zero CAC.”
  • STAT News notes,
    • “An interim look at an Alzheimer’s disease clinical trial evaluating an amyloid-targeting treatment from ProMIS Neurosciences showed low rates of brain bleeding and no incidences of brain swelling — results reported Tuesday that suggest the drug could be safer than approved treatments. 
    • “In a blinded analysis that pooled safety data from patients receiving the ProMIS drug and a placebo, the total rate of ARIA was 4.4%, with all cases mild and asymptomatic, the company said.” * * *
    • “ProMIS expects all the participants in the Phase 1 study to complete twelve months of treatment late this year, allowing the company to unblind the data and report full results, including measures of cognition and function, early in 2027.” 
  • Genetic Engineering and Biotechnology News adds,
    • “Neurodegenerative diseases are typically defined by the presence of characteristic clinical phenotypes. However, it is increasingly recognized that early intervention could give people the best chance for meaningful positive effects. As a result, early detection and prevention are becoming major priorities.
    • “Months to several years before amyotrophic lateral sclerosis (ALS) symptoms arise, levels of certain blood proteins may dramatically shift. By anticipating the arrival of symptoms, investigators could intervene with preventative therapies before the irreversible motor neuron damage that is characteristic of ALS sets in.
    • “In this study, researchers analyzed data from the long-running, National Institutes of Health (NIH)-funded Pre-symptomatic Familial ALS (Pre-fALS) study, to identify a lineup of key proteins that may predict the emergence of clinically manifest ALS.
    • “This work is published in Nature Medicine in the paper, “Longitudinal plasma proteomics predict phenoconversion to clinically manifest ALS.”
  • Per an Institute for Clinical and Economic Research news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of vaccines for protection against Covid-19, including: Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi).
    • “ICER examined the impact of Covid-19 vaccines and found that pregnant women, infants, and adults aged 65+ benefit most from vaccination. ICER’s report on this therapy was the subject of the June 2026 public meeting of the New England CEPAC, one of ICER’s three independent evidence appraisal committees. The New England CEPAC was aligned with ICER’s report findings.
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
    • “The current confusion in the US around vaccine policy is challenging for both health care professionals and the American public,” said ICER’s President and CEO Sarah K. Emond, MPP. “Policymakers, especially public health leaders, need reliable and unbiased assessments of how well therapies work for patients. For 20 years, ICER has delivered that through our evidence-based analyses and public meetings. This public meeting highlighted what we know about the current evidence on Covid-19 vaccines, and where there are opportunities to gain an even better understanding of how these vaccinations impact different subpopulations. Ultimately, ICER’s transparent and public process sheds light on the broader context that policymakers should consider when making recommendations about Covid-19 vaccines.”

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

  • MedCity News reports,
    • “It’s often said that the healthcare system is broken, from the outdated use of fax machines to perverse incentives.
    • “But who broke the healthcare system? At MedCity News’ Bullseye event in Chicago, Editor-in-Chief Arundhati Parmar posed this question to two health insurance CEOs.
    • “The response? “We did,” replied Sachin Jain, CEO of SCAN Health Plan, referring to all of those who work inside of healthcare. He added that healthcare stakeholders have normalized the abnormal.” * * *
    • “The CEO of Ascendiun, Paul Markovich, echoed this. Ascendiun is a nonprofit and parent company of Blue Shield of California, Blue Shield Promise Health Plan, Altais and Stellarus.
    • “It’s our own damn fault collectively, and I think that’s why we’re trying to focus a lot of our energy on the system. … One of the reasons I work at a health plan and a nonprofit health plan is because I think what the health plans can do is create a better system,” he said. “We tend to control the rules of how people get paid, what are the administrative burdens? Are we using a fax machine, or are we figuring out another way to connect digitally? We have the biggest influence, I think, in trying to shift the system to getting much better results from people day to day than what we’re seeing now.”
  • Healthcare Dive relates,
    • “Centene handily beat Wall Street’s expectations in the second quarter, as higher revenue from premiums and rate hikes for the managed care company’s plans shielded its bottom line from elevated medical costs.
    • “Centene posted $53.6 billion in revenue, up 10% year over year, and $1.1 billion in profit in the quarter. That’s compared to a loss of $253 million the same time last year when Centene was caught off guard by higher spending — the insurer’s first quarterly loss in more than two years.
    • “Centene raised its 2026 financial outlook on Tuesday following the outperformance, which TD Cowen analyst Ryan Langston called “huge.”
    • “Any way you slice it, this was a fantastic quarter,” CFO Drew Asher said during a morning call with investors.”
    • “It’s the second beat-and-raise this year for the St. Louis-based insurer, following a buoyant first quarter when Centene bumped its 2026 guidance on the back of better controlled medical costs.” 
  • BioPharma Dive tells us,
    • “GSK is turning to a multibillion-dollar cost-cutting program to help the company grow profits while absorbing the impact of a sizable patent cliff.
    • “In its latest quarterly earnings report on Tuesday, the British pharmaceutical company revealed a three-year restructuring plandesigned to save a total of about £1.9 billion, or $2.5 billion, per year. GSK didn’t disclose specific details about the plan, but said that it should “simplify the organization” and help “reallocate capital and resources” towards specialty medicines.
  • MedTech Dive adds,
    • “Boston Scientific announced a global restructuring that will involve changes to its supply chain and organizational structure.
    • “The heart device company said in a Monday securities filing that it expects “some headcount reductions,” though it will still post new jobs in areas of growth. Boston Scientific did not say how many positions it expects to cut. The company did not respond to MedTech Dive’s request for comment by publishing time.
    • “In total, the company expects about $700 million to $800 million in pre-tax charges, according to the filing. The restructuring, approved by the company’s board, is expected to start this year and be complete by the end of 2029.”
  • Beckers Payer Issues informs us,
    • “Deferred elective surgery was a through-line of second-quarter earnings calls at four of the country’s largest for-profit hospital operators. But their executives do not agree on what is driving the slowdown, or whether it represents lost demand at all.
    • “Nashville, Tenn.-based HCA Healthcare, Franklin, Tenn.-based Community Health Systems and Dallas-based Tenet Healthcare all reported softness in elective volumes, particularly in high-acuity areas such as orthopedic and cardiac care that generate some of hospitals’ strongest margins. 
    • “King of Prussia, Pa.-based Universal Health Services reported milder surgical softness alongside a broader volume rebound and pinned the weakness on a different cause.
    • “The distinction matters because the competing explanations point to very different futures. If patients are postponing care they cannot afford, the volume loss reflects a demand problem that additional capital and capacity will not solve. If cases are shifting to lower-cost settings, the revenue has not disappeared; it has just moved somewhere else.”
  • Beckers Hospital Review points out,
    • “New Hampshire is the best state for healthcare while Alaska is the worst, according to an analysis published July 27 by WalletHub.
    • “The personal finance company compared the states and the District of Columbia across three dimensions: cost, access and outcomes. Analysts then evaluated the dimensions across 44 metrics, including average monthly insurance premiums, hospital beds per capita, emergency room wait times, infant mortality rates and the share of patients readmitted to hospitals. Each metric was graded on a 100-point scale, with 100 representing the best healthcare at the most reasonable cost. WalletHub then calculated each state’s weighted average across all metrics to produce an overall score and used the resulting scores to rank the states. 
    • “Iowa ranked first for cost, North Dakota ranked first for access and New Hampshire ranked first for outcomes.”
  • Beckers Clinical Leadership notes,
    • “Of the 679 U.S. hospitals designated as “Magnet” hospitals for nursing excellence, about 5% have earned the recognition more than six times. 
    • “The American Nurses Credentialing Center awards Magnet recognition to hospitals based on their quality of patient care and nursing excellence. As of July 28, 36 hospitals have received six or more Magnet designations — representing just 0.6% of the nation’s 6,100 hospitals. 
    • “Since Dec. 31, 2025, four hospitals have earned their sixth Magnet designation: Englewood (N.J.) Hospital, Hospital for Special Surgery in New York City, Penn Medicine Lancaster (Pa.) General Hospital and Houston Methodist Hospital.
    • [The article lists} the 36 hospitals that have received this honor six or more times.
  • Per Fierce Healthcare,
    • “LifeBridge Health’s Sinai Hospital of Baltimore is putting an artificial intelligence-powered diagnostic for sepsis into clinical use, bringing a research-backed tool to the patients’ bedside.
    • “Chicago-based Prenosis, a biology-based technology company, developed Sepsis ImmunoScore, an AI-powered tool that can spot the early signs of sepsis. The tool analyzes 22 parameters to identify patterns in a patient’s biological immune response, enabling clinicians to detect sepsis or its progression within 24 hours.
    • “Sepsis ImmunoScore received the U.S. Food and Drug Administration’s first authorization for software to diagnose sepsis in 2024. Prenosis’ solution was approved through the FDA’s De Novo pathway.”
  • and
    • “Virtual care and health navigation company Included Health inked a deal to acquire Firefly Health to scale health plan alternatives for employers.
    • “In January, Included Health launched an alternative health plan design for employers, broadening its existing all-in-one virtual care platform. Firefly Health, founded in 2017, is a primary care and health plan provider serving more than 20,000 individuals nationally. 
    • “The deal is expected to close in the third quarter of 2026. The companies did not disclose financial details of the acquisition.”

Monday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “As the Senate speeds toward its upcoming August recess, President Donald Trump is turning up the pressure on Senate Majority Leader John Thune to keep his chamber in session and in Washington instead. 
    • “So far, that’s unlikely.  “You could stay here till Christmas” and the situation wouldn’t change, Thune said. “If I thought there was a path to getting a result, I’m all for it.” 
    • “The president posted to Truth Social on Monday morning that “Thune should not allow the United States Senate to ‘leave town’ until it passes” the SAVE America Act, a GOP-crafted package that would require proof of citizenship to register to vote and photo ID at the polls.
    • “The sweeping bill does not have the 60 votes needed to advance through the Senate — a message the South Dakota Republican leader has reiterated both publicly and privately to the other end of Pennsylvania Avenue.” 
  • Per a U.S. Senate Committee news release,
    • “On Thursday, July 30, the Senate Health, Education, Labor, and Pensions (HELP) Committee will vote on bills to increase Americans’ educational opportunities and give them more tools to secure a strong retirement. The Committee will also vote the nominations for Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services, the Director of the Centers for Disease Control and Prevention, and the Secretary of the U.S. Department of Labor.”
  • Govexec relates,
    • “While lawmakers are debating what an appropriate regulatory framework for artificial intelligence should be, experts who spoke at a panel on Monday noted that federal employees have been using the technology for years to develop all sorts of regulations. 
    • “Cary Coglianese, a regulation professor at the University of Pennsylvania, said that agencies, for example, have been using AI to analyze thousands of public comments that some proposed rules receive. 
    • “Back in the day, contractors would literally photocopy comments, clip them out and sort them in different categories — and do what essentially natural language processing tools can do now so quickly and rather effectively,” he said. 
    • “But as the technology advances, speakers on the panel — which was sponsored by the Coalition for Sensible Safeguards, a left-leaning group of more than 220 regulatory-focused organizations — argued that AI could take over more steps in the rulemaking process, potentially supercharging the Trump administration’s efforts to slash regulations and downsize the federal government.”
  •  FEHBlog observation: The government can use AI for many more tasks, and you don’t have to be left leaning to be concerned about this development.
  • Fierce Healthcare tells us,
    • “A tiny federal agency tasked with protecting the public from injuries caused by lawn mowers and coffeemakers is demanding that some of the nation’s biggest health systems turn over detailed, personally identifiable medical records of all patients who seek help at their emergency rooms.
    • “The Consumer Product Safety Commission, responsible for tracking and issuing recalls of dangerous products sold in the U.S., began discreetly pressuring hospital executives this year to share personally identifiable health data with a private contractor. But hospital lawyers and other industry experts have questioned the agency’s authority to collect, its ability to safeguard such a swath of sensitive information, and whether it has followed the legal process to overhaul its surveillance system.
    • “After KFF Health News asked the CPSC about the new system, the agency announced the program on July 21. Left unmentioned, however, is the alarm it has raised among hospital executives, as well as the nature and extent of the agency’s data demands.”
  • and
    • “A new analysis finds that Medicare Advantage enrollees spend less on average than those in the traditional program, but report similar satisfaction levels.
    • “ATI Advisory conducted the study on behalf of the Better Medicare Alliance, analyzing data from the Medicare Current Beneficiary Survey and Cost Supplement files from 2021 to 2023. The analysis found that MA enrollees spent $2,824, or 36%, less out-of-pocket on average in 2023 compared to those in fee-for-service Medicare.
    • “And the difference in spending has risen over time, with savings 16% higher in 2023 than in 2022, according to the report.
    • “Twelve percent of MA beneficiaries said they faced a significant cost burden, or spent more than 20% of their income on healthcare, compared to 24% of people enrolled in traditional Medicare.”
  • Beckers Payer Issues adds,
    • Medicare Advantage will account for 57% of overall Medicare enrollment by 2036, up from 51% this year, according to a July report from the Congressional Budget Office.
  • and
    • “Four more Medicare Advantage prescription drug plans have received five-star ratings thanks to CMS’ recalculation.” * * *
    • In a July 21 letter to MA organizations, CMS said ratings stayed the same for 61%, increased for 9% and declined for 30% of contracts. The agency did not change ratings for plans that had worse performance in the latest review. The threshold for MA plans earning additional payments is four out of five stars. Top plans get their own perks, though, such as special enrollment period privileges and further rebate benefits.
    • CMS clarified to Becker’s that it only updated overall ratings, not the separate Parts C and D summary ratings, on the plan finder.
    • Here are the four contracts joining the five-star club:
      • Renown Health
        • Hometown Health Plan (Senior Care Plus) — Contract H2960
      • Rifkin Managed Care Holding
        • Provider Partners Health Plan of Texas — Contract H4054
        • Provider Partners Health Plan of Pennsylvania — Contract H4093
      • Longevity Health Founders

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • Nearly 100 people in 17 states have been sickened in a salmonella outbreak tied to recalled eggs, federal health officials said Friday.
    • The 98 people had illnesses that started between Nov. 21 and June 30, according to the FDA. No deaths have been reported, but 26 people have been hospitalized.
    • Investigators have determined that shell eggs recalled by Midwest Poultry Services are a likely source of the germ, but the Indiana-based company doesn’t account for all the illnesses.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved Freenome’s blood-based screening test for colorectal cancer, called SimpleScreen CRC. Abbott will exclusively market the test in the U.S., starting this fall, the companies said Monday.
    • “Abbott already sells the Cologuard stool test for colorectal cancer screening, following its $21 billion acquisition of Exact Sciences earlier this year. Through its collaboration with Freenome, Abbott now adds a blood test to its colorectal cancer screening portfolio.
    • “SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening, which gained FDA approval in 2024. TD Cowen analysts said that with a very large population of patients who are unscreened, “We see room for multiple players.”
  • Fierce Pharma relates,
    • “The FDA has approved Otsuka Pharmaceutical’s once-daily extended-release capsule Simtriyo (centanafadine) for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.
    • “Approval of the first-in-class norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) gives the Japanese drugmaker its “next major CNS launch” and positions the therapy to become a potential blockbuster in a large, under-penetrated market, according to Jefferies analysts in a July 26 note.
    • “Before Simtriyo can launch in the U.S. market, it must clear controlled-substance review by the Drug Enforcement Administration (DEA), a standard, up-to-three-month procedure for all central nervous system stimulants.”
  • Contemporary OB/GYN informs us,
    • “Roche received FDA 510(k) clearance for its cobas BV/CV (Bacterial vaginosis/Candida vaginitis) assay, a molecular diagnostic test that returns results for both conditions from a single vaginal swab. The assay is intended for professional laboratory use, based on a clinician’s order, the company noted in a July 24, 2026, news release.
    • “The test uses real-time polymerase chain reaction technology to identify the specific bacteria and yeast species that are responsible for BV and CV in symptomatic patients. Roche stated that the assay is designed to support faster, more accurate diagnosis than syndromic evaluation alone, with the goal of improving both patient outcomes and laboratory efficiency.
    • “BV and CV are among the most common causes of vaginal symptoms in the United States, and both conditions can present with overlapping symptoms that complicate clinical diagnosis based on history and examination alone.”
  • NBC News San Diego CA points out,
    • “The Food and Drug Administration has recalled a commonly prescribed thyroid medication.
    • “The recall involves levothyroxine sodium tablets that are used to treat hypothyroidism and decrease the size of enlarged thyroid glands, according to Mayo Clinic.
    • “The FDA said they had been functioning as “subpotent drugs,” meaning they had less of an active ingredient and were ultimately less effective.
    • “Major Pharmaceuticals packaged and distributed the recalled tablets, while Cardinal Health also distributed some of the recalled products.
    • “Twelve different dosages and cartons from the two companies were listed in the FDA’s recall notice. You can read the full list here.”

From the judicial front,

  • Bloomberg Law reports,
    • “Novo Nordisk A/S is asking a federal judge to halt Eli Lilly & Co.’s advertisements for its GLP-1 drugs, escalating a legal fight against the company’s campaign for weight loss treatments.
    • “The company said Friday [July 24] it filed a motion for preliminary injunction seeking to block Lilly’s advertisements of its obesity drugs, days after filing a lawsuit accusing the company of deceptive promotions. 
    • “Misleading advertisements that selectively compare lower doses of Novo Nordisk’s medicines against higher doses of Lilly’s medicines, based on outdated studies, leave patients with the mistaken impression that Lilly’s drugs are vastly superior, and that is simply not true,” John F. Kuckelman, senior vice president and group general counsel of Novo, said in a statement.”
  • and
    • “Johnson & Johnson on Monday said it agreed to a $5.5 billion commitment to resolve litigation related to claims that its talc products caused ovarian cancer. 
    • “The drugmaker said the proposed resolution represents “an efficient conclusion” to the lawsuits. The agreement requires the participation of lead plaintiff firms in ovarian talc litigation pending in state and federal court that represent at least 95% of claims, according to J&J. 
    • “While we are confident the company would have ultimately prevailed with further litigation, as it has in the vast majority of cases tried to date, this resolution allows the Company to put this matter behind it and remain focused on its mission to develop medicines and devices that save lives,” J&J Vice President of Litigation Erik Haas said in the statement on the company’s website.” 
  • Beckers Payer Issues identifies five health system vs. payer lawsuits to watch.

From the public health and medical / Rx research front,

  • Health Day reports,
    • “More than one-third of women and one-quarter of men engage in intentional outdoor tanning, with variance observed by age, race, physical activity level, and alcohol use, according to a study published online July 22 in JAMA Dermatology.
    • “Dawn M. Holman, M.P.H., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues examined the prevalence of intentional outdoor tanning among U.S. adults. The analysis included 31,615 adults participating in the 2024 National Health Interview Survey.” * * *
    • “These findings support the need to address intentional outdoor tanning in the context of skin cancer prevention,” the authors write. “The variation in demographic and behavioral factors points to venues for future research and interventions.”
  • The American Medical Association lets us know “what doctors want patients to know about summer skin safety” and “what doctors want patients to know about cardiac stress tests.“
  • The American Hospital Associagtion News relates,
    • “The Substance Abuse and Mental Health Services Administration July 27 released results from its latest national survey on drug use and mental health. The survey found that fewer adolescents 12-17 and adults 18-25 used alcohol, tobacco, marijuana and other drugs between 2021 and 2025. In addition, 27.6% of adolescents received mental health treatment in the past year, while 21.6% of adults 18 or older received treatment. The survey highlighted additional findings on suicide, substance use treatment and recovery.”
  • and
    • “The Association for the Advancement of Blood and Biotherapies Interorganizational Task Force on Domestic Disasters and Acts of Terrorism announced July 24 that the U.S. blood supply is at significant risk for shortages due to weeks of decline in blood donations. The task force said the reduced supply is more pronounced in certain areas of the country, and in some areas blood collectors are already reporting an impact on the availability of blood for some patients. The organization is urging eligible donors to make and keep an appointment to donate blood as soon as possible. An AHA Member Advisory will be issued on the matter, which will include a call to action and resources for conserving blood supplies.” 
  • MedPage tells us,
    • “Despite the availability of multivalent pneumococcal vaccines, infants remain susceptible to invasive pneumococcal diseases.
    • “In this French study, infants immunized against RSV with nirsevimab were about 35% less likely to be hospitalized for invasive pneumococcal disease through 9 months.
    • “The rise in pneumococcal disease cases in kids involving serotypes not covered by vaccines highlights the need for complementary prevention strategies, the researchers said.”
  • and
    • “Diabetes and weight loss are associated with an increased risk of fragility fractures, which can be associated with substantial morbidity and mortality.
    • “In this retrospective study of adults with type 2 diabetes, those starting a GLP-1 drug had a 21% lower risk of fragility fractures over 3 years compared with initiators of a DPP-4 inhibitor.
    • “The lower fracture risk associated with GLP-1 drugs was independent of changes in body mass index.”
  • Health Day adds,
    • “Worried that your Ozempic is becoming less effective over time?
    • “Don’t worry — you’re still eating less, even if you are feeling a bit hungrier, a new study says.
    • “People on semaglutide for weight loss continue to eat less even after they’ve taken the drug for more than a year, researchers report in the August issue of The American Journal of Clinical Nutrition.
    • “While some of the drug’s early reduction of hunger and food-related thoughts wanes over time, people continue to eat substantially fewer calories compared to others provided a placebo, researchers found.”
  • MedScape notes,
    • “A compression device worn around the abdomen during colonoscopy reduced cecal intubation time by more than 1.5 minutes and significantly lowered post-procedural pain, the need for manual abdominal pressure, and patient position changes. Greatest improvements were seen in patients who were lean or had obesity.”
  • Per a National Institutes of Health news release,
    • “Months to several years before amyotrophic lateral sclerosis (ALS) symptoms arise, levels of certain blood proteins may dramatically shift. Researchers analyzed data from the long-running, National Institutes of Health (NIH)-funded Pre-symptomatic Familial ALS (Pre-fALS) study, to identify a lineup of key proteins that may predict the emergence of clinically manifest ALS. By anticipating the arrival of symptoms, investigators could intervene with preventative therapies before the irreversible motor neuron damage that is characteristic of ALS sets in.
    • “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,” said senior author Michael Benatar, M.D., Ph.D., a professor of neurology and public health sciences at the University of Miami. “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.”

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

  • Beckers Payer Issue tells us eight things to know about healthcare spending trends. 
  • Modern Healthcare reports,
    • “Cone Health CEO Dr. Paul Krakovitz said the system is focusing on value-based care coordination.
    • “Cone’s parent system, Risant Health [,a subsidiary of Kaiser Permanente], provides a national network with added scale and expertise to operate in a highly competitive healthcare market.
    • “Krokovitz said the system is expanding to take advantage of North Carolina’s booming population growth.” * * *
    • “We’re coming up on our second anniversary soon. The tools that Risant is bringing us in terms of value-based care and giving us national scale have been impressive. They’ve been very open-minded. Most importantly, they’ve stuck to the value of the deal, which has been making sure Cone Health remains a community-based health system.”
  • Beckers Hospital Review relates,
    • “King of Prussia, Pa.-based Universal Health Services recorded an operating income of $516.7 million (11.1% operating margin) during the second quarter of 2026, compared to an operating income of $500.3 million (11.7% margin) during the same period last year, according to its July 27 financial report.” * * *
    • “UHS operates 30 inpatient acute care hospitals, 346 inpatient behavioral health facilities, about 170 outpatient and other facilities, a health plan and a physician network in 40 states, Washington, D.C., Puerto Rico and the United Kingdom.”
  • Leapfrog posted its 2026 hospital safety ratings.
  • The Wall Street Journal informs us,
    • “Argenx agreed to buy Forte Biosciences for $2.2 billion to strengthen its immunology pipeline.
    • “The purchase price of $77 a share in cash represents a 41% premium to Forte’s closing price on Friday.
    • “The deal adds Forte’s experimental drug FB102, which Argenx said has potential to address multiple autoimmune diseases.”
  • and
    • “AstraZeneca reported higher second-quarter sales driven by cancer medicines and said it remains on track to hit its 2030 revenue target.
    • “AstraZeneca’s second-quarter revenue rose to $15.38 billion from $14.46 billion, driven by a 15% increase in oncology product sales.
    • “Chief Executive Pascal Soriot sought to reassure investors after a recent trial failure raised doubts about the company’s 2030 revenue goal.”
  • MedCity News discusses “What Happens When Patients Trust AI Over Their Doctor?”
    • As patients increasingly bring AI chatbot advice into exam rooms, where does liability land when that advice goes wrong? Health law attorney Meghan O’Connor said the answer still isn’t clear, but silence is the riskiest response for providers.

Friday report

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., defied expectations and kept his fractured conference together to pass several priority items before House members jetted home on Thursday to kick off a five-week recess. 
    • “But how much of that legislation their colleagues in the Senate will take up is a different question, as divisions continue to deepen.
    • “The House adopted a GOP-backed budget resolution along party lines on Wednesday, taking the first step toward passing a $95 billion reconciliation package that’s focused mostly on the Iran war. 
    • “But Senate Majority Leader John Thune, R-S.D. has remained lukewarm on such a package, especially if it includes certain aspects of the so-called SAVE America Act, which would require proof of citizenship to register to vote and photo ID at the polls. 
    • “I can’t count 50 right now on a budget resolution,” Thune told reporters on Thursday. He said the path to clearing the chamber’s so-called Byrd bath, which assesses compliance with reconciliation rules, “is still an open question.”
  • Beckers Clinical Leadership relates,
    • “HHS has rewritten the governing charters for the Advisory Commission on Childhood Vaccines and the National Vaccine Advisory Committee.
    • “The ACCV charter, filed July 21, removes the standalone designated federal officer section that appeared in the previous version, which specified that a full-time federal employee would approve meeting agendas, call meetings and maintain public-facing information on the committee’s activities.
    • “In its place, the new charter refers more broadly to “the federal official responsible for ACCV oversight” calling or approving meetings. The revised charter also adds a provision allowing that federal official, if appointed by the HRSA administrator, to serve as temporary chair if ACCV members have not selected a chair and vice chair. The ACCV advises the HHS secretary on the National Vaccine Injury Compensation Program, including changes to the Vaccine Injury Table and how the government collects and uses vaccine adverse event data.
    • “The revised NVAC charter adds duties not previously included in the panel’s purview, directing members to weigh what it terms “non-immunization strategies,” including healthy lifestyle and disease prevention initiatives, off-label use of already approved drugs and dietary supplements marketed for immune support.”
  • Govexex tells us,
    • “The National Active and Retired Federal Employees Association on Thursday said the Office of Personnel Management still has not sufficiently protected federal workers and retirees as part of a plan to collect claims-level health data in an effort to root out fraud.” * * *
    • “[I]n a letter to [OPM Director Scott] Kupor Thursday, NARFE National President William Shackelford said that while his organization appreciates the steps taken thus far to shield FEHBP and PSHBP participants’ identities, he remains troubled by OPM’s insistence that it be able to re-identify employees via their health records in the future. Under the Health Insurance Portability and Accountability Act, health care data should be not just pseudonymized, but de-identified entirely, he wrote.
    • “NARFE’s position is straightforward. OPM has moved in the right direction,” Shackelford wrote. “But we asked for de-identified data and OPM has offered pseudonymized data, and those are not the same commitment. Pseudonymization does not remove the risk that our members’ health information will be linked back to them; it makes that linkage a matter of OPM’s discretion, exercisable by whoever holds the relevant authority in any future administration.”
    • “Additionally, most of OPM’s reassurances about privacy and the data collection’s anti-fraud purpose exist solely within Kupor’s blog post, and not the proposal published in the Federal Register last month.”
  • Over 700 public comments were submitted by yesterday’s deadline. As the FEHBlog has noted, OPM is not giving FEHB and PSHB carriers and the OPM Inspector General credit for preventing most fraud, waste and abuse in these programs.
  • The American Hospital Association News informs us,
    • “The U.S. Trade Representative yesterday announced it is implementing a 10% or 12.5% tariff on 60 trading partners, which became effective today. These tariffs follow an investigation under Section 301 of the Trade Act of 1974 for lacking or failing to enforce a ban on goods produced with forced labor, according to the agency. Nations that the USTR said had made commitments to adopt and effectively enforce forced labor import prohibitions will receive a 10% tariff, while nations that the agency said had failed to adopt a forced labor import ban will receive a 12.5% tariff. The USTR notice outlines which products are excluded from the new tariffs, including products already subject to Section 232 tariffs, products qualifying under the U.S.-Mexico-Canada trade agreement and certain pharmaceuticals and pharmaceutical ingredients.”
  • and
    • “The Consumer Product Safety Commission yesterday announced it is modernizing the National Electronic Injury Surveillance System, the national database for tracking consumer product-related injuries. The CPSC said that it will replace its manual coding process, used since 1972, with an electronic data exchange through a Qualified Information Network. The new system, NEISS-Remodel, will expand the network to all 50 states, up from 36 under the previous system. NEISS-R is expected to become fully operational by the beginning of 2027.” 

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • It’s been over two months since Dr. Marty Makary stepped down from his post as FDA commissioner, and there has yet to be visible progress toward naming his permanent successor. The gap in leadership is sparking concerns among industry watchdogs that pharma could lack clear guidance on federal priorities for weeks or months to come.
    • The Trump administration has yet to name a nominee to replace acting commissioner Kyle Diamantas — and there are currently multiple hurdles in front of any confirmation process. In particular, the Senate isn’t going to be around much in the coming months. 
  • The Wall Street Journal relates,
    • “Biohackers, longevity enthusiasts and alternative medicine doctors want the peptide BPC-157. Now compounders may be one step closer to lawfully providing it. 
    • “The Food and Drug Administration’s Pharmacy Compounding Advisory Committee voted in favor of easing restrictions on six of seven peptides up for consideration, following strong warnings from the agency’s scientists. It’s now up to the FDA to decide whether to greenlight the drugs for compounding pharmacies to make—and pave the way for a peptide gold rush.
    • * * * “The committee voted against one peptide called Emideltide, evaluated for opioid withdrawal, chronic insomnia, and narcolepsy. David Pope, a pharmacist who voted affirmatively for other peptides, voted “no” on this one, citing a complex regimen and “potentially dangerous downstream consequences.”
  • USA Today tells us,
    • “Consumers will soon have a new over-the-counter pain relief option that combines Tylenol with naproxen, an anti-inflammatory medication.
    • “The Food and Drug Administration on July 24 approved the non-prescription combination of 650 mg of Tylenol (acetaminophen) and 220 mg of naproxen sodium.
    • “The non-opioid tablet can be used by adults and children aged 12 and ​older for temporary relief of headaches, back pain, muscle aches, toothache, menstrual cramps and minor pain from arthritis, the FDA said.
    • ‘Kenvue, which owns Tylenol, said the tablet combination will soon be available for purchase without a prescription at major retailers.”
  • Fierce Pharma informs us,
    • “With all eyes on Tavneos’ seemingly precarious approval status in the U.S., Amgen is advancing plans to defend the ANCA-associated vasculitis (AAV) drug it inherited in its $3.7 billion buyout of ChemoCentryx. 
    • “The California pharma on Thursday submitted data and analyses to the FDA to help secure a hearing in hopes of keeping Tavneos on the U.S. market. The package includes a third-party re-evaluation of the med’s controversial pivotal trial, real-world evidence and patient and HCP testimonials.
  • Cardiovascular Business lets us know,
    • “Penumbra is recalling specific lots of its RED 68 Perfusion Catheter due to an ongoing safety concern. 
    • “The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall. This means using the device without following the manufacturer’s recommendations could lead to “temporary or medically reversible adverse health consequences.” 
    • ‘The recall was put in place due to a risk of the catheters fracturing. Penumbra has said “manufacturing issues” are to blame, but the company is still investigating the issue to learn more.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 24, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Considering multiple data sources, COVID-19 activity is low and stable nationally but is beginning to show early signs of an increase in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) is elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The American Hospital Association News reports,
    • “There have been 2,318 confirmed measles cases in the U.S. so far this year, the most in the country since 1991, according to the latest data from the Centers for Disease Control and Prevention. There were 2,289 cases in 2025. Cases this year have been reported by 45 jurisdictions. The CDC said that 93% of cases are outbreak-associated. The vaccination status of 93% of cases is unvaccinated or unknown. The agency said that 7% of cases this year have been hospitalized, lower than last year’s figure of 11%.”
  • The Washington Post offers an opportunity to check out your county’ measles vaccination rates for kindgarteners.
    • “The share of U.S. counties where 95 percent or more of kindergartners were vaccinated against measles — the number doctors say is needed to achieve overall protection for the class, known as “herd immunity” — has dropped from 50 percent before the pandemic to 28 percent, according to The Post’s examination of the public records from 44 states and the District of Columbia.”
  • The Wall Street Journal tells us,
    • “Public-health officials are investigating four additional states as part of a multistate cyclospora outbreak linked to iceberg lettuce that they warn could be even broader.
    • Illinois, Kansas, Oklahoma and Pennsylvania are the latest states added to the investigation, the Centers for Disease Control and Prevention said Friday. The health agency said last week it was investigating the outbreak in Indiana, Kentucky, Michigan, Ohio and West Virginia. 
    • “The CDC said epidemiologic data continued to show the outbreak stemmed from the consumption of iceberg lettuce from Taylor Farms. Nearly 2,000 people who ate food from Taco Bell have been sickened in those nine states during the outbreak, the agency said. Nearly 100 people have been hospitalized. 
    • “The iceberg-lettuce outbreak might be even broader than what health authorities have found. The authorities are investigating a number of food-related outbreaks, including several involving cyclospora, a parasite that causes explosive diarrhea. For now, the authorities are probing the various cyclospora outbreaks as if they are distinct, but it is possible they are related and investigators so far haven’t been able to connect them.”
  • and
    • “Warmer winters and changes in land use are driving ticks carrying Lyme disease and alpha-gal syndrome into new areas such as Ohio and Michigan.
    • “In 2025, Lyme disease cases jumped more than 60% in Ohio and almost 80% in Michigan as blacklegged tick populations expanded.
    • “Lone-star ticks, which cause the meat allergy alpha-gal syndrome, are established in 19 counties in Ohio and five in Michigan.”
  • The New York Times points out,
    • “The same chemical process that turns a baking cake golden brown is at work aging your body’s cells. Over decades, your tissues, baking steadily at 98.6 degrees, slowly accumulate compounds called advanced glycation end products, or AGEs, as sugars interact with protein and fat in the bloodstream. The buildup of AGEs is a hallmark of the aging process, making tissues like collagen sticky and rigid and causing inflammation that can lead to heart disease, eye damage, kidney disease and diabetes.
    • “Researchers have tried unsuccessfully to develop medications that can stop AGEs from forming. But a new study, published on July 16 in the journal Nature Communications, describes a different tack: Scientists created an enzyme that cleans one of the most common AGEs from human tissue, helping to turn back the clock even after the aging compounds have settled in the body. This cleanse can help repair the tissue and has the potential to allow cells to act younger.
    • “It’s a small step in this bigger direction, because aging is very complicated,” said Aaron Cravens, a founder and the chief executive of Revel Pharmaceuticals, which developed the new enzyme, and the lead author of the study. “It’s the first time, I think, that anyone in the field has shown at the structural level that you can actually reverse some of these changes.”
  • MedPage adds,
    • “Exceptional memory at age 80 and beyond was not due simply to good genes, an analysis of prospective data suggested.
    • “The study assessed outcomes for superagers — people 80 or older with episodic memory at least as good as adults 20 or 30 years younger — and cognitively average controls.
    • “Genotype distributions and APOE status did not differ between groups, reported Ignazio Stefano Piras, PhD, of the Translational Genomics Research Institute at City of Hope in Phoenix, and co-authors.
    • “Neither APOE nor any of three polygenic risk scores predicted whether a person would be a superager, Piras and colleagues wrote in Alzheimer’s Research & Therapy. Results were similar after accounting for global non-European or African ancestry.”
  • Health Day informs us,
    • “About 50% to 88% of children with autism experience motor skill challenges
    • “Organized sports — especially martial arts and aquatic training — can improve motor skills
    • “Consistently large improvements were seen in balance, coordination, overall motor skills and object control.”
  • and
    • “Increases in a problematic social media use may contribute to worsening attention-deficit/hyperactivity disorder (ADHD) symptoms during adolescence, particularly among boys, according to a study published online July 17 in JAMA Network Open.”
  • The Wall Street Journal notes,
    • “Ipsen said its drug Bylvay missed the primary objective in a late-stage clinical trial for biliary atresia, a rare liver disease affecting babies.
    • “Bylvay missed the study’s primary objective of showing an improvement in native liver survival rates compared to a placebo, Ipsen said.
    • “Ipsen said biliary atresia, the leading cause of pediatric liver transplants, has no approved therapeutic options beyond surgery or transplant.”
  • Per BioPharma Dive,
    • “Sanofi is calling it quits on an experimental eczema drug that it had seen as a potential successor to its blockbuster medication Dupixent, according to a Friday announcement.
    • “Sanofi had said in January that it intended to seek clearance of the drug, amlitelimab, in atopic dermatitis despite mixed late-stage study results and signs of possible safety concerns. On Friday, though, the French pharmaceutical firm said that, during a pipeline review, it found that the “totality of efficacy and safety evidence generated to date” doesn’t support further development of amlitelimab in that indication.
    • “Sanofi’s decision follows a recent move by Amgen and Kyowa Kirin to shelve a similar experimental medicine. The pharma company will continue testing amlitelimab in celiac disease, though, and is slated to reveal data from a mid-stage study by the end of the year.”

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

  • Fierce Healthcare reports,
    • “HCA Healthcare on Friday affirmed its earlier warnings about Affordable Care Act (ACA) exchange subsidies fallout, telling analysts that patients who dropped off marketplace plan coverage due to increased premiums have “migrated almost one for one” to uninsurance. 
    • “The country’s largest for-profit brought in $20.23 billion in second-quarter revenue, up 8.7% year-over-year, net income of $1.69 billion, up 2.8%, and adjusted EBITDA of $4.027 billion, up 4.6%, according to financial results published Friday morning. The company also reported diluted earnings per share increasing 11.6% to $7.62 per share.
    • “In particular, a payer mix shift driven by increased uninsured volumes had an “unfavorable impact” on income of approximately $400 million before income taxes, above its estimates from earlier in the year.”
  • and
    • “Clinician-led artificial intelligence platform Anterior and health tech company Stellarus entered a strategic partnership Thursday to tackle automating prior authorizations.
    • “The partnership aims to support providers through automating tasks—such as case research and policy application—to allow teams to focus on complex determinations. The companies say providers will receive quicker, first-time approvals, ultimately giving members quicker care access. 
    • “Stellarus provides the healthcare technology platform, integration expertise and operational experience to help health plans put AI into practice, while Anterior brings leading clinical AI to automate the research, documentation and policy application that support prior authorization,” said Vanessa Colella, Stellarus president and CEO.”
  • and
    • “Addressing healthcare’s biggest challenges will require payers and providers working together.
    • “That’s why the team at Aetna has spent the past several years investing in ways to bridge those trust gaps and better unite the two sides of the industry that are often at odds. And a new survey suggests that work is paying off.
    • “Morning Consult polled 723 provider executives across multiple disciplines on Aetna’s behalf, and found an average provider trust score of 6.1 on a scale of one to 10. By comparison, a similar poll conducted in the first quarter found a 5.4 trust score.”
  • Modern Healthcare relates,
    • “Surgery Partners plans to sell its ownership interest in two Idaho hospitals to Intermountain Health.
    • ‘The proposed transaction, which values the facilities at an estimated $1.15 billion, would include Surgery Partners’ Idaho Falls Community Hospital and Mountain View Hospital, also in Idaho Falls, along with affiliated clinics.
    • “Surgery Partners is expected to receive about $795 million in the transaction, according to a Friday news release.”
       
  • MedTech Dive tells us,
    • “Edwards Lifesciences reported strong sales of its heart valves in the second quarter and outlined several upcoming catalysts expected to maintain solid growth rates, starting with an anticipated Medicare coverage expansion.
    • “Sales were better than the company expected for transcatheter aortic valve replacement devices, Edwards’ largest product line, as well as newer repair and replacement treatments for mitral and tricuspid diseases, due to increasing clinical demand, executives said on a Thursday earnings call.
    • “CEO Bernard Zovighian tied TAVR demand to growing evidence backing earlier use of the procedure to treat aortic stenosis patients and predicted the “durable” momentum would support the company’s 10% total sales growth target long term.”
  • Fierce Pharma informs us,
    • “After a post-[July 4th] holiday lull, prescriptions for GLP-1s have more than bounced back. Weekly prescriptions for Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo reached new highs during the previous week, collecting 169,800 and 26,760, respectively, according to IQVIA data cited by Citi. The two oral drugs’ previous records were about 161.5K and 24.3K, respectively. 
    • “Other GLP-1 drugs also enjoyed a boost, as total GLP-1 scripts across obesity and diabetes increased 6.6% sequentially, according to Citi.
    • “Against this backdrop, Lilly’s oral Foundayo seemed to enjoy a small inflection point, with a total 24,303 scripts notably breaking away from its roughly 20K level in the prior five weeks.  
    • “Meanwhile, joining the bigger trend, Wegovy pill scripts dropped to 147.5K during the week, versus about 153K the prior week or 161.5K at its peak. But the contribution of the oral version to the overall Wegovy scripts remained stable at around a third, per Citi’s note.” 

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • Bloomberg Law reports,
    • “The health insurance industry is adding to scrutiny of the American Medical Association’s control of billing codes, voicing resistance to the group’s planned overhaul of how doctors bill health plans for maternity care.
    • “Insurers say they didn’t have enough time to prepare for the change, while AMA claims the industry didn’t raise concerns during the development process. The dispute is gaining attention from policymakers amid a broader political rift between the AMA and Republicans over the country’s healthcare billing system.
    • “The AMA develops and trademarks the Current Procedural Terminology, or CPT, codes that doctors use to bill insurers for medical services. The codes are baked into government programs like Medicare, and critics—as well as Medicare’s payment advisory panel—have long questioned the conflict of interest in letting AMA help determine doctors’ payments.” * * *
    • “Overall, the new protocol eliminates 17 codes in favor of 12 new codes and six revised codes. AMA developed the codes over the course of three years with its CPT panel, which includes seats for representatives nominated by health insurance trade group AHIP and the Blue Cross Blue Shield Association. The codes were released in April, before the typical September release, to give everyone more time to prepare.
    • “But insurers say it’s not enough, pointing to the fact that babies due to be born in 2027 are already on the way. And while insurance representatives serve on the panel, participants are legally blocked from sharing information about the meetings, according to AHIP.” * * *
    • “The Centers for Medicare & Medicaid Services last week proposed extending the current coding system for an additional year alongside the new codes, saying it’s concerned the change will be disruptive.”
  • Beckers Payer Issues relates,
    • “Committees in the House and Senate each advanced healthcare price transparency legislation this week, both aiming to expand disclosure requirements for hospitals, insurers and other healthcare providers.  
    • “Both measures would expand the existing hospital and payer price transparency rules, bring ASCs and labs under similar mandates for the first time and add new reporting requirements for insurers, pharmacy benefit managers and health plan administrators, though they differ on penalty structures, effective dates and scope.” * * *
      • Patients Deserve Price Tags Act
        • “The Senate Committee on Health, Education, Labor and Pensions advanced legislation July 22 that would implement new price transparency requirements for hospitals, insurers, laboratories, imaging providers and ASCs, while also expanding group health plans’ access to claims and reimbursement data held by insurers and PBMs.
        • “The committee passed the Patients Deserve Price Tags Act by a vote of 21-1, one of several healthcare bills advanced together in the same en bloc vote. The bill now heads to the full Senate.
      • The Lower Costs, More Transparency Act
        • The House Energy and Commerce Committee advanced a broad healthcare price and cost transparency package July 21 in a 45-0 vote that would also expand price transparency rules for hospitals, insurers, ASCs and the administrators of employer-sponsored health plans if signed into law.
        • The bill was also referred to the House Ways and Means and Education and Workforce committees.
  • The Hill adds,
    • “Bipartisan legislation to cap the cost of insulin at $35 for people with private health insurance advanced through a key Senate committee Wednesday, but its future remains uncertain. 
    • “The measure cleared the Senate Health, Education, Labor and Pensions [HELP”] Committee by a bipartisan 17-5 vote, with six Republicans joining every Democrat on the panel.” 
  • STAT New notes,
    • “People with diabetes who use a popular long-acting insulin pen made by Sanofi have had to become pharmacy scouts in recent weeks as they encounter supply issues.
    • “The Lantus Solostar pen containing 3 milliliters of insulin glargine has been running low for several weeks because of increased demand “driven by broader market dynamics,” a Sanofi spokesperson told STAT. The issue is not technically considered a shortage by the Food and Drug Administration, but patients are nonetheless having trouble finding the medication.”* * *
    • “Pharmacists can try to switch patients over to Semglee or Rezvoglar, the FDA-approved biosimilars, if their insurance allows that. Or they could ask prescribers to go for Lilly’s Basaglar, which comes in pen form.”
  • Thompson Reuters tells us about
    • Rev. Proc. 2026-26 (July 21, 2026). Available at https://www.irs.gov/pub/irs-drop/rp-26-26.pdf
      • “The IRS has announced 2027 indexing adjustments for important percentages under the Affordable Care Act (ACA). The indexing adjustments are based on projections of premium growth and income growth. For 2025 and several years prior, the premium growth rate was based on per enrollee spending for employer-sponsored insurance as published in the National Health Expenditure Account. However, HHS revised the measure to also capture increases in individual market premiums, starting with the 2026 benefit year. The IRS is applying this updated premium growth measure for 2027 as well.
      • “The required contribution percentage is used to determine whether employer-sponsored health coverage is “affordable” for purposes of employer shared responsibility under Code § 4980H. It is adjusted from a 9.5% baseline to 10.22% for plan years beginning in 2027. (This is an increase from 9.96% for 2026.) The percentages used to determine the amount of household income that individuals who are eligible for premium tax credits must contribute toward the cost of Exchange coverage vary across household income bands. The 2027 percentages range from 2.15% to 10.22%.”
  • STAT News informs us,
    • “The Senate’s [HELP] panel delayed until next week a vote on Erica Schwartz to run the Centers for Disease Control and Prevention, after postponing a separate vote on Sean Kaufman for a key public health preparedness role.”
  • and
    • “Nearly 18 months after taking office, President Trump has nominated a leader for the federal agency that oversees mental health and addiction policy. 
    • “If confirmed by the Senate, Timothy Westlake, a Wisconsin-based physician with decades of experience in both clinical and policy roles, would serve as assistant secretary of mental health and substance use. The position would also make him head of the Substance Abuse and Mental Health Services Administration, which has operated without a long-term leader since Trump was inaugurated in January 2025.” 
  • Tammy Flanagan, writing in Govexec, discusses “Why your retirement experience may depend more on the agency than the benefit.”
    • “Federal retirees interact with OPM, the Thrift Savings Plan and Social Security at different stages of retirement. Their latest performance data reveals starkly different customer service experiences and highlights where delays remain most likely.”
  • OPM Director Scott Kupor added (Substack link) a post to this Secrets of OPM blog. This one concerns the vital importance of investment income to benefit programs.
    • “The federal government manages a number of trust funds, but the two largest are the Social Security Trust Fund (about $2.7 trillion today) and the Civil Service Retirement and Disability Funds (CSRDF) (about $1.1 trillion today), the latter of which we at the Office of Personnel Management (OPM) have the privilege of overseeing.”
    • “It’s unlikely we are going to get Congress to eliminate the Treasury-only investment restrictions on the Social Security Trust Fund or the CSRDF. One can dream, but we all know that hope is not a strategy. However, all hope is not lost – and we at OPM have partnered with the Treasury Department to change what we can to the benefit of the American taxpayer.
    • “Enter “duration.”
    • “A very quick lesson on the economics of treasuries (and bonds more generally). Treasuries have varying expiration dates (or “duration,” as the finance nerds prefer). For example, you can buy Treasury bills (less than 1-year in duration), Treasury notes (with 2, 3, 5, and 7-year durations) and Treasury bonds (with 20 and 30-year durations). It’s not always the case, but in general the longer the duration, the higher the interest rate the government will pay you on the bond. Today, a 30-year duration bond pays about 5% in annual interest, whereas the 10-year pays 4.5% and a 1-year pays 4%.
    • “Historically, the CSRDF has had an average duration across its entire Treasury portfolio of about 7.5 years. That means, that we had lots of different maturities, ranging from less than 1-year to up to 15-years, but the average was right in the middle. As a result, we have achieved the roughly 3-4% annualized returns that I mentioned above on the overall fund balance.”* * *
    • “Partnering with Treasury, we concluded that a longer average duration was appropriate for the CSRDF from a risk and pension liability perspective and would yield a better economic return to the fund. As a result, OPM has increased our duration from 7.5 years to 15 years by adding longer-date treasuries (e.g., 20- and 30-year bonds) to the portfolio.
    • “Who cares? Well, this enabled us to increase the expected investment return of the portfolio to approximately 4.4%.”

From the Food and Drug Administration front,

  • A Dallas Texas NBC TV station reports,
    • “The FDA announced that nearly 20 million eggs (more than 1.5 million cartons) are being recalled due to the risk of Salmonella.
    • “Midwest Poultry Services voluntarily issued the recall of white shell eggs and brown cage-free shell eggs that were sold at Kroger and Brookshire Grocery stores in Texas, as well as smaller retail outlets.
    • “The eggs are also sold in Louisiana, Oklahoma, Arkansas, New Mexico, and Mississippi.
    • “The eggs were produced and distributed in Texas between June 6 and July 3; the latest sell-by or best-by date is Aug. 17.
    • “The recalled eggs will have an identifying code number printed on the left or right sides of the carton in date-coding ink only. Only codes P-1950 or 0840962 with a Julian Date between 157 and 184 printed on the side of the carton are recalled.”
  • Fierce Pharma relates,
    • “An FDA advisory committee has recommended that two peptide drugs that were previously restricted because of potential safety concerns be restored to the 503A Bulk Drug Substances list, which would remove the restrictions on how they are produced by compounders.
    • “Eight of the 15 members of the Pharmacy Compounding Advisory Committee (PCAC) voted to add both drugs back to the list, with six members voting ‘no’ and one abstaining. 
    • “BPC-157 and KPV are the first two of seven drugs that are being reviewed Thursday and Friday by the PCAC. In 2023, 12 peptides were reclassified, which restricted their use. In addition to safety concerns, the FDA cited a lack of evidence supporting their efficacy.”
    • “BPC-157, which is not approved by the FDA, is a synthetic anti-inflammatory peptide used to treat ulcerative colitis. BPC-157 and KPV, also an anti-inflammatory,  have also gained popularity in wellness and fitness influencer circles for supposed soft-tissue healing and bone repair capabilities. 
    • “The FDA is not required to follow the recommendations of the PCAC. The agency will make the final decision on whether the peptides can be manufactured by compounders.”  
  • The Wall Street Journal informs us,
    • “The U.S. Food and Drug and Administration said Wednesday it is investigating an additional cyclospora outbreak that the agency said has sickened at least 72 people.
    • It is the latest of four continuing cyclospora outbreaks being investigated by the FDA. The largest involves at least 1,644 cases, which have been linked to shredded iceberg lettuce supplied by Taylor Farms and served at Taco Bellin five states. 
    • “The companies have said that the shredded lettuce, sourced from central Mexico, has been removed from the U.S. market. Taylor Farms said last week that it voluntarily recalled iceberg lettuce grown and processed in Mexico, including products sold in grocery stores and restaurants across 27 states in the U.S.
    • “The FDA hasn’t yet identified a source for any of the other cyclospora outbreaks.”
    • “The FDA also said it was investigating at least 106 reported cases of salmonella and eight cases of listeria. The sources of those illnesses have yet to be identified.”

No Surprises Act News

  • Modern Healthcare reports,
    • “The Centers for Medicare and Medicaid Services and its contractors can’t keep up with the ceaseless onslaught of No Surprises Act out-of-network billing cases, federal data show.
    • “Providers and health insurance plans initiated 1.43 million Independent Dispute Resolution arbitrations this year through May, 46% more than during the comparable period in 2025. The system resolved 1.36 million cases over those five months.” * * *
    • “There’s no real end in sight,” said Lawson Mansell, a senior health policy analyst at the Niskanen Center, a centrist think tank.
    • “There have been 6.3 million cases since Independent Dispute Resolution began in 2022, and arbitrators have resolved 5.9 million. Providers file the lion’s share of cases.” * * *
    • “The new gateway may reduce the backlog, Mansell said. But because providers can win large payments, they have an incentive to continue filing many cases, he said.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Health and Human Services Department will fight to restore policies it says are vital to protecting the health insurance exchanges against fraud.
    • “HHS filed an appeal with the U.S. Court of Appeals for the 4th Circuit on Tuesday to reverse a decision the U.S. District Court for the District of Maryland handed down last month that invalidated portions of a program integrity final rule the Centers for Medicare and Medicaid Services issued last year.
    • “Democratic elected officials representing Baltimore, Chicago and Columbus, Ohio, are the lead plaintiffs in the case alongside the left-leaning advocacy groups Doctors For America and the Main Street Alliance. The plaintiffs contend CMS didn’t follow proper regulatory procedure when it issued the regulation.” * * *
    • “Last week, the same district court temporarily blocked sections of a separate health insurance exchange rule in a case brought by some of the same plaintiffs.”
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services yesterday released implementation guidance following a district court ruling July 16 that enjoined eight provisions from its 2027 notice of benefit and payment parameters final rule, which were set to become effective July 20. The rule issues standards for qualified health plans offered through the health insurance marketplaces. “Accordingly, for plan year 2026, Exchanges must immediately begin to update their systems to stop removing or denying advance payments of the premium tax credit for any new applicants or existing enrollees due to having failed to file and reconcile prior years’ premium tax credits,” CMS wrote. “Exchanges must continue in this manner for plan year 2027.” The agency said that the Department of Health and Human Services reimplemented the automatic 60-day time extension to resolve inconsistencies in household income data.”

From the public health and medical / Rx research front,

  • Fox News reports,
    • “As New York City continues to investigate an outbreak of Legionnaires’ disease that has claimed multiple lives and sickened dozens of people, doctors say there are ways people can reduce the risk of exposure.
    • “As of July 21, there have been five deaths and 82 diagnoses linked to the Upper East Side outbreak, according to the New York City Department of Health and Mental Hygiene. Eight patients remain hospitalized.
    • “Health officials said no new cases had been reported in the previous six days, suggesting the source of exposure has likely been eliminated, although the investigation remains ongoing.
    • “Legionnaires’ disease is a serious type of pneumonia that is typically spread by tiny water droplets containing Legionella bacteria, according to the Centers for Disease Control and Prevention.”
  • The Wall Street Journal informs us,
    • “Many people are reconsidering their Caesar salad lunches and berry breakfasts as cases of cyclosporiasis, the explosive-diarrhea illness, continue to rise in the U.S.
    • “The good news is, they don’t have to. The Centers for Disease Control and Prevention hasn’t recommended that people cut fresh produce out of their diets, only that they avoid recalled iceberg lettuce from Taylor Farms.
    • “We asked food-safety experts what we know—and don’t—about how to safely eat produce right now.” * * *
    • The only food recalled in connection with the current cyclosporiasis outbreak is iceberg lettuce from Taylor Farms de Mexico, sourced from central Mexico. The CDC lists all of the affected products here. Of course, this list could grow so consumers should keep an eye on the latest news.
    • “The vast majority of fresh fruits and vegetables are safe to eat, food-safety experts say. All fresh produce carries some inherent risk, separate from the cyclosporiasis outbreak, but experts say the health benefits of eating these foods generally outweigh those. 
    • “It’s a special time of year,” said Kali Kniel, a professor of microbial food safety at the University of Delaware. “Go to the farmers market, buy local if you can, where you know a farmer in your area has grown that directly.”
    • “Commercial processing can magnify certain food-safety risks, including chopping and shredding in large facilities where a single contaminated leaf can mix with other produce. For salad lovers, experts recommend buying whole heads of lettuce and removing and discarding the outer couple of layers of leaves.
    • “Mixed-lettuce bags might make life easier, but they are particularly risky since the lettuce is pulled from different sources, said Marion Nestle, a professor emerita of nutrition, food studies and public health at New York University.” * * *
    • “Cooking produce to 158 degrees Fahrenheit is the surest way to eliminate risk of contamination, experts say. 
    • “Peeling, too, or removing outer layers of produce, is another effective safeguard. Cyclospora parasites often become entrapped in produce through contaminated water used to grow or wash it, so areas that come into contact with water are more likely to be affected. 
    • “Freezing might reduce some risk by eventually killing eggs of the parasite, but doesn’t guarantee safety.”
  • and
    • “Congratulations if you’re among the country’s nearly 56 million ex-smokers. Many health benefits are coming your way—some of them within just a few minutes.
    • “Over the long term, though, the health picture gets a lot more complex. Some problems caused by smoking take decades to clear up, and certain lung damage can’t be fixed. Plus, a higher risk for lung cancer never completely fades.
    • “Even so, there are plenty of steps ex-smokers can take to boost the benefits from quitting, from changing their diet to beefing up their exercise regimen. Even if restoring pristine lung condition isn’t an option, doctors say quitting still matters—both for health and quality of life.
    • “Quitting is absolutely one of the most powerful things that someone can do for their health at any stage, at any time,” says Eric Singhi, a thoracic medical oncologist with the MD Anderson Cancer Center in Houston.”
  • Cardiovascular Business tells us,
    • “Approximately 20 million routine chest CT scans are performed for non-cardiac reasons in the U.S. each year. They represent a large untapped opportunity to detect coronary artery disease.
    • “That’s according to a presentation at SCCT2026, the Society of Cardiovascular Computed Tomography (SCCT) annual meeting, by Suhny Abbara, MD, MSCCT, senior associate consultant and professor of radiology at Mayo Clinic in Jacksonville, Florida, editor-in-chief of Radiology, the flagship journal of the Radiological Society of North America (RSNA), and a former SCCT president. He urged health systems to capitalize on the incidental findings already visible on millions of imaging exams.
    • “As a cardiac CT person, I think I can make less of a difference population-wise with coronary CT,” Abbara said. “Those are patients that are already on our radar. There is a huge number of patients, 20 to 40 times more, where we can detect coronary atherosclerosis serendipitously in a CT done for other reasons.”
  • Health Day relates,
    • “Obesity treatment for young people in the U.S. is rapidly changing.
    • “Adolescents and young adults are increasingly using GLP-1 weight-loss medications, while rates of bariatric surgery are declining, according to a study published July 20 in JAMA Pediatrics.
    • “This research is the first national-scale Epic Cosmos analysis, to our knowledge, to characterize real-world use of combined GLP-1 receptor agonist therapy and metabolic and bariatric surgery among adolescents and young adults with obesity,” said lead author Sarah Messiah, associate dean for research at UT Southwestern’s Peter O’Donnell Jr. School of Public Health.
    • “Researchers analyzed records from more than 204,000 patients between 13 and 25 years of age who were treated for obesity between May 2022 and January 2026.
    • “They found exclusive GLP-1 use increased from 88.2% in 2022 to 96.1% by early 2026. During the same period, bariatric surgery rates fell from 11.6% to 3.7%.”
  • BioPharma Dive adds,
    • “Eli Lilly on Thursday bolstered the case for its new experimental obesity medicine, announcing the success of two more Phase 3 trials and plans to seek approval of the drug next year. 
    • “The Triumph-2 and Triumph-3 studies build on research released in May that found the drug, retatrutide, could help people lose 30% of their body weight after 104 weeks, reaching a level associated with bariatric surgery. The two new trials included overweight or obese patients who also had either type 2 diabetes or cardiovascular disease.
    • “The overall weight loss in the two studies was less than in the Triumph-1 study released in May, showing an average of 21% body weight loss after 80 weeks in the diabetes group and 23% loss in the cardiovascular disease cohort at the highest doses. Still, those results met expectations for patients with underlying conditions who often lose less weight, RBC Capital Markets analyst Trung Huynh wrote in a note to clients.”
  • The American Hospital Association lets us know “what doctors want patients to know about heart failure.
    • “Heart failure can affect energy, breathing and daily life, but early diagnosis, treatment and follow-up can help people manage symptoms.”
  • Fierce Pharma reports,
    • Johnson & Johnson has unveiled massive phase 3 survival data for its dual bispecific combination in earlier-line multiple myeloma, delivering another catalyst that could add a new twist in the commercial trajectories of off-the-shelf T-cell engagers versus personalized CAR-T therapies.
    • The combination of J&J’s Tecvayli and Talvey slashed the risk of disease progression or death by 89% compared to standard-of-care cocktails in second- to fifth-line multiple myeloma patients, according to results from the phase 3 MonumenTAL-6 trial. 
    • In another remarkable showing, the two T-cell engagers targeting BCMA and GPRC5D delivered a 62% reduction in the risk of death, J&J announced Thursday.

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

  • Beckers Hospital Review reports,
    • “Dallas-based Tenet Healthcare recorded an $826 million net income in the second quarter of 2026, up from $288 million during the same period, according to its July 23 financial report. 
    • “The publicly traded for-profit system reported operating income of $1.5 billion (26.7% operating margin) during the three months ended June 30, up from $823 million (15.6% margin) during the same period last year. 
    • “Total operating revenue was $5.6 billion in the second quarter of 2026, a 6.8% increase year over year. Tenet received $413 million in revenue in Q2 from the early conclusion of Conifer’s revenue-cycle services contract with Chicago-based CommonSpirit Health, bringing full control of the company back under Tenet. 
    • “Tenet’s salaries, wages and benefits totaled $2.23 billion in Q2 2026, a 3.3% increase year over year. Supply expenses totaled $984 million, a 5.6% increase. Other operating expenses totaled $1.2 billion, a 4.9% increase. 
  • and
    • “Most patients decide on a hospital before settling on a physician — or land on both in the same step — when they first encounter a new health concern, according to survey results U.S. News & World Report published July 20.
    • “U.S. News worked with PureSpectrum to poll 500 Americans nationwide who had personally arranged care for themselves or a family member within the past two years.
    • “Fifty-three percent of respondents said the hospital came first in their decision, or that hospital and physician were chosen together. The other 47% picked their physician before the hospital entered the picture.
    • “When a preferred physician cannot practice at a patient’s hospital of choice, 80% follow that physician to a different facility rather than give up the relationship. Only 20% take the opposite route, opting for a different physician to stay at the hospital they want.
    • “Patients trust referrals from physicians the most when it comes to sources of information about hospitals, averaging at 4.0 on a five-point scale of trustworthiness. Next was data directories, such as online directories or hospital websites, at 3.5 to 3.7, followed by AI chatbots, social media and podcasts, at 2.7 to 2.8.
    • “Age shifts that picture: patients between 26 and 40 place nearly as much trust in podcasts, AI chatbots and social platforms as they do in referrals or hospital websites — a gap that is far wider among older patients. That same younger group also leans on consumer reviews: 81% said sites like Google and Yelp shape what they decide.”
  • Beckers Physician Leadership points out five things to know about “the forces reshaping physician compensation in 2026.”
  • Fierce Healthcare tells us,
    • “Teladoc Health unveiled a new virtual care model for employers and health plans designed to offer a more coordinated, personalized approach for members, while tying payment to clinical and financial outcomes.
    • “The model, called Teladoc One, was built to replace fragmented, condition-specific healthcare programs with an integrated offering that dynamically supports a person’s entire health needs rather than only addressing one disease at a time, company executives said. As part of the model, Teladoc Health care teams deliver and coordinate care across virtual settings and in partnership with a member’s local providers. 
    • “Teladoc One, fundamentally, is a new care model that’s changing the way that we deliver care,” Kelly Bliss, president of U.S. Group Health at Teladoc Health, told Fierce Healthcare in an interview.”
  • and
    • “Cigna Healthcare is taking steps to significantly expand its personalized care management programs, leaning on AI to identify risks sooner and simplify the patient journey.
    • “Through the initiative, Cigna’s care teams use predictive analytics to identify individuals who may benefit from supports or intervention earlier, which can avert more negative outcomes or disease progression down the road.
    • “The insurer also deploys its more than 1,250 clinicians, including nurse managers and behavioral health professionals, to guide the care journey. They are empowered to coordinate care between providers and point members to supports available through their health plan that may be beneficial.”
  • and
    • “Erlanger Health System plans to join Prisma Health, creating a 27-hospital system in exchange for a $2 billion strategic capital commitment toward care in the Chattanooga, Tennessee area.
    • “The nonprofit health systems announced their signed non-binding letter of intent Wednesday morning but did not provide a tentative timeline for the deal. A final agreement will require approvals from Erlanger’s board of directors, who already have backed the deal, as well as Erlanger’s independent oversight monitor board, the local county commission and other state and federal regulators. 
    • “The pair said their proposed partnership will boost access to specialty care, better fund long-term capital projects, secure “mission critical programs” such as southeast Tennessee’s only Level 1 trauma center and other safety-net operations, and generally help the organization grow amid a toughening operating environment.” 
  • Beckers Health IT lets us know,
    • “OpenAI has expanded Health, a ChatGPT feature that lets users securely connect personal health data, to all eligible users in the U.S.
    • “The rollout covers logged-in users age 18 and older on web and iOS across the Free, Go, Plus and Pro plans, according to a July 23 OpenAI news release.
    • “Health lets users connect Apple Health data and supported medical records from U.S. hospital systems, One Medical or Function Health. With permission, ChatGPT can then use that information across any conversation, not just within a dedicated Health tab, to compare lab results, summarize changes since a last appointment, or factor in a recent injury or dietary restriction.
    • “OpenAI said the wider release builds on a limited early test in which more than 70% of health-related conversations happened outside the dedicated Health space, prompting the company to fold that context into everyday chats. Connected medical records and Apple Health data, along with conversations that use them, are not used to train OpenAI’s foundation models or target ads, the company said. Users can disconnect data sources at any time, and connected data is deleted from OpenAI’s systems within 30 days.
    • “The feature runs on GPT-5.5 Instant for free users and GPT-5.6 Sol for paid users, both developed with input from physicians and evaluated on OpenAI’s HealthBench Professional benchmark.” 
  • The Wall Street Journal adds,
    • “One of the looming worries about artificial intelligence is that it will automate away jobs. A report from researchers at Google released Thursday says that, so far, the technology is mainly being used as an aid to workers.
    • “It is a finding that, if it holds true as AI continues to develop, could point to a future where the demand for highly skilled workers is accentuated rather than diminished. 
    • “Just because you’re using AI doesn’t mean it’s going to automate your job,” said Google economist Scott Strand, one of the researchers.” * * *
    • “The research says that while workers in higher-paid occupations tend to use AI more, its use isn’t limited to jobs typically held by college-educated workers. People in manual and technical trades, such as electricians and auto mechanics, are using AI significantly as a hands-on collaborator, and are uploading images and videos to solve problems far more frequently than their white-collar counterparts. 
    • “The research also finds that people are turning to AI to help speed up drudge work at home, such as dealing with government paperwork, building household budgets or helping with home repairs. The gains people are getting from AI use at home are unlikely to show up in standard economic statistics.”

Midweek report

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

Simplicity is a virtue

From Washington, DC

  • Beckers Payer Issues calls attention to eight bills in Congress that payers should be following.
  • Per a Senate news release,
    • “Today the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted to favorably report multiple bills making health care more affordable and accessible to American families.” * * *
    • “The National Plan for Epilepsy Act, Expedited Access to Biosimilars Act, and Making America’s Food Safer Act passed unanimously 22-0 as amended in an en bloc vote. The Patients Deserve Price Tags Act, CLEAR LABELS Act, EMPOWER for Health Act, Title VIII Nursing Workforce Reauthorization Act of 2025, and Rural Obstetrics Readiness Act passed 21-1 as amended in an en bloc vote. The SAFE Drugs Act of 2026 passed as amended 17-5, the INSULIN Act of 2026 passed as amended 17-5, and the Childhood Diabetes Reduction Act passed as amended 12-10.”
  • Bloomberg Law reports,
    • “Legislation advanced on a bipartisan basis by the House oversight panel Wednesday aims to regulate pharmacy benefit managers contracting with health benefits for federal employees.
    • “The measure (H.R. 6610) would set standards for pharmacy reimbursement, require that drug rebates be applied to copayments and coinsurances, and prohibit PBMs from steering beneficiaries to specific pharmacies for the Federal Employees Health Benefits Program. The measure was approved 40-2.
    • “For too long, federal employees and tax payer-funded federal agencies have been held captive by a health care system manipulated at every turn by three large PBMs and their affiliate companies,” said Oversight Chair James Comer (R-Ky.).”
  • FEHBlog observation: The bill would price fix small molecule drug prescriptions. It’s not a good idea from a market place standpoint to set prices in statutes. The next step for this bill is House floor consideration, but the House will be on a District work break beginning tomorrow until August 31. So, there is time for cooler heads to prevail.
  • CBS News relates,
    • “The Trump administration is forging ahead with a controversial plan to collect the medical records of millions of federal workers and retirees, as well as their family members.
    • “The Office of Personnel Management said in a notice posted last month that it will begin routinely collecting identifiable, personal health information on more than 8 million people — despite concerns from privacy advocates and Democrats, who have demanded the agency drop the plan. The notice will go into effect July 24, allowing OPM to begin its collection at any point afterward.” * * *
    • “In its latest notice, OPM argues that the vast trove of data is necessary to ferret out fraud and overpayments in the FEHB and PSHB programs. Those programs cost roughly $80 billion a year, with about $50 billion covered by the federal government and $30 billion funded by enrollees. The Trump administration has ramped up efforts, led by Vice President JD Vance, to curtail what it says is rampant fraud and misuse of publicly funded health benefits.
    • “The effort still faces criticism that it doesn’t go far enough to protect the privacy of federal workers and their families.
    • “Clearly, this administration has not earned our trust with Americans’ sensitive data,” Sen. Mark Warner (D-Va.) said in an emailed statement to KFF Health News. “If OPM wants to work in good faith to reduce fraud, they should come to Congress, including to folks like me who are engaged on this issue and represent many federal workers and retirees and their families, and work to build consensus and trust before implementing these sweeping changes.”
  • FEHBlog observation: OPM overlooks the fact that carriers, who hold the financial risk in the FEHB and PSHB programs, already focus on preventing fraud, waste, and abuse, in cooperation with the OPM Inspector General’s office. Carriers submit annual reports on those efforts to OPM.
  • Per an OPM news release,
    • “ICYMI: OPM Director Scott Kupor Discusses Merit-Based Federal Hiring and Restoring Accountability on The Ingraham Angle.”
  • Beckers Hospital Review informs us,
    • “President Donald Trump plans to place tariffs on generic drug imports, building on the 100% tariff he imposed on patented pharmaceutical products in April. While that policy exempted generic drugs and biosimilars for the time being, the White House said it would reassess the exemption within a year. 
    • “Here are three things to know from the latest announcement, made in a July 21 Truth Social post:
      • “The tariff schedule would be rolled out over three years. Starting Aug. 1, generic drugs will continhttps://www.hhs.gov/press-room/hhs-joins-genesis-mission-ai-chronic-disease-research.htmlue entering the U.S. tariff-free for a two-year period. After that, the tariff rises to 100% for one year, then to 200% thereafter.
      • “President Trump said the schedule is meant to “reshore” generic pharmaceutical production into the U.S., calling the escalating tariffs a “penalty” for companies that do not build manufacturing plants and equipment domestically within the two-year window.
      • “President Trump said the policy on patented, branded or innovative drugs “will remain as is.” Under the April policy, those tariffs are set to take effect July 31 for large companies and Sept. 29 for smaller firms, with reduced or zero rates available to companies that reach most favored nation pricing agreements with HHS and onshoring agreements with the Commerce Department. This announcement effectively replaces the one-year review window for generics with a defined, longer timeline.”
  • The American Hospital Association News points out,
    • “The Department of Health and Human Services July 22 announced that it will participate in the Genesis Mission, an artificial intelligence initiative focusing on scientific research that originated from a November 2025 executive order. HHS will work with the Office of Science and Technology Policy to launch a series of science and technology challenges involving AI, including one focusing on identifying root causes of chronic disease and others on pediatric cancer research and drug discovery and development.
    • “In addition, OSTP July 22 released a report, “Science: A New Golden Age,” on scientific initiatives using AI. The report outlines four pillars: revitalizing America’s science and technology enterprise through recommendations such as refocusing on individual scientists and diversifying funding mechanisms; securing U.S. dominance in critical and emerging technologies through efforts such as public-private partnerships and challenges; ensuring science and technology betters the lives of all Americans through recommendations such as training and career pathways; and launching a golden age of science through efforts such as the Genesis Mission. An annex to the report, the “White House Fiscal Year 2028 Research and Development Budget Priorities Memorandum,” consists of directives for federal agencies to implement recommendations in the report.” 
  • Per Department of Health and Human Services news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced that the Centers for Medicare and Medicaid Services (CMS) sent a notification urging every State Medicaid Director to phase out the use of mercury-containing dental fillings by restricting or ending their respective state’s Medicaid coverage for dental procedure codes for “dental amalgams.” Dental amalgams are a material that combines mercury with other heavy metals to fill cavities but pose health and environmental risks.”
  • Healthcare Dive notes,
    • “The Department of Labor’s employee benefits arm proposed a rule Wednesday that would allow insurers to share mandatory group health plan disclosures with their beneficiaries electronically.
    • “Many of the communications, like summary plan descriptions, claims denials or notices that coverage can continue after a job loss, are currently sent via physical mail. But if the rule is finalized, plans will be able to post the documents online and notify a member by text or email when a disclosure is available.
    • “It’s “a big step forward in how Americans receive important information about their health benefits,” Daniel Aronowitz, who leads the DOL’s Employee Benefits Security Administration, said during a press briefing.”

From the Food and Drug Administration,

  • MedPage Today reports,
    • “The FDA approved zidesamtinib (Jideytro) for previously treated adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), drugmaker GSK announced Wednesday.
    • “Zidesamtinib is a next-generation, brain-penetrant ROS1-selective inhibitor designed to overcome ROS1 resistance mutations.
    • “Approval was based on the phase I/II ARROS-1 trial that included patients with ROS1-positive NSCLC who were previously treated with a ROS1 kinase inhibitor. In the overall population of 117 patients, the objective response rate (ORR) was 44%, with rates of duration of response at 6 and 12 months of 82% and 69%, respectively.”
  • MedTech Dive relates,
    • “Johnson & Johnson said Wednesday it received Food and Drug Administration de novo authorization for its Ottava robotic surgery system to perform multiple procedures in general surgery.
    • “The authorization brings to the U.S. market a second heavyweight challenger to Intuitive’s da Vinci robot in soft tissue procedures, following Medtronic’s FDA clearance in late 2025. A wave of smaller companies, including CMR Surgical, Distalmotion and Moon Surgical, are also launching robotic systems in the U.S., giving Intuitive its first competition in more than two decades.
    • “J&J said it will launch Ottava with select U.S. customers while working to obtain additional indications and regulatory jurisdictions over time.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The participating manufacturer intends to offer a device for use in providing care expected to be covered by the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model and intended to improve health outcomes for Americans managing certain chronic diseases.
    • “The FDA selected Dexcom, Inc., as the first participant in the TEMPO pilot. The Dexcom Glucose Health Program, which the FDA will continue to evaluate for its intended use during the pilot, is intended to address two clinical use areas in the ACCESS Model.
    • “The Dexcom Glucose Health Program is intended to enable patients aligned to the ACCESS model and their healthcare professionals or caregivers to monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights for informed decision-making and behavioral modifications. The program is intended as an aid in the screening for prediabetes and type 2 diabetes through integrated digital health metrics. It may also contribute to improving glycemic control and lowering HbA1c in people with prediabetes.”
  • and
    • “The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again. The FDA is issuing a final order revoking the authorized use of Orange B as a color additive in food and is proposing to revoke the authorized use of Citrus Red No. 2 as a color additive in food.”

No Surprises Act News

  • The Wall Street Journal reports,
    • “A controversial process for arbitrating medical billing disputes awarded nearly $15 billion in payouts to healthcare providers last year, according to new federal data analyzed by The Wall Street Journal, more than triple the total for 2024.
    • Doctor groups representing radiologists, anesthesiologists and emergency-room physicians have been among the winners under the setup, which was created under a 2020 law meant to protect patients from surprise medical bills. Insurers have to make the awarded payouts, and they have generally ended up on the losing end since arbitration began four years ago.
    • “For 2025, total payouts under the arbitration process reached $14.85 billion, according to a Journal analysis of new, previously unreleased data from the Centers for Medicare and Medicaid Services. The figure for 2024 was $4.08 billion, according to the analysis.
    • ““It’s shocking that it’s rising so fast,” said Jack Hoadley, a research professor emeritus at Georgetown University’s Center on Health Insurance Reforms.”
  • FEHBlog observation: It is indeed a big bowl of wrong.

From the judicial front,

  • Fierce Healthcare reports,
    • “The Trump administration will appeal a Georgia court ruling that triggered a broad recalculation of insurers’ Medicare Advantage star rating scores for 2026.
    • “In court documents filed Tuesday, federal agencies said they would appeal the ruling to the Eleventh Circuit Court of Appeals. In late May, a judge in Georgia’s Southern District Court came down in favor of Clover Health, tossing 20 measures that the Centers for Medicare & Medicaid Services used to calculate its scores.
    • “The court cut 10 of those measures, as the judge determined CMS exceeded its statutory authority in the data sources used, while the remaining 10 were rejected because the court ruled CMS did not meet its rulemaking and comment requirements to use them.”
    • “The ruling also triggered several follow-up lawsuits from other payers over the calculations, including Elevance Health, Alignment Healthcare and SCAN Health Plan.”
  • Per a Department of Justice news release,
    • “A federal jury in the Southern District of Florida convicted a Florida licensed pharmacist and pharmacy owner yesterday for her role in dispensing over 300,000 oxycodone 30mg pills to pharmacy patrons who had no medical need for the drug.
    • “According to court documents and evidence presented at trial, Olushola Yusuf, 60, of Tampa, dispensed oxycodone to nearly all her pharmacy customers. Yusuf charged customers approximately 10 times the typical cost of the drug and required payment from them in cash. In total, Yusuf dispensed at least 335,351 pills of oxycodone 30mg during the conspiracy. Oxycodone 30mg is the maximum strength available of the drug and is both sought after and potentially dangerous due to its potency. It is typically prescribed to seriously ill patients, such as those suffering from chronic cancer pain or traumatic injuries.”

From the public health and medical / Rx research front,

  • Beckers Clincal Leadership informs us,
    • “In the nation’s largest outbreak of cyclosporiasis, the CDC has reported 4,940 lab-confirmed and 341 hospitalizations across 41 states, according to a July 21 update. 
    • “Between May 1 and July 20, the federal health agency reported 4,173 domestic cases and 767 illnesses acquired outside the U.S. A majority of hospitalizations, 308, are also domestically linked.
    • “In 2025, the U.S. recorded 3,955 cyclosporiasis cases, meaning the number of illnesses over the past 11 weeks have exceeded last year’s total, according to the Washington Post. 
    • “The FDA and CDC’s traceback investigations have “converged” on now-recalled iceberg lettuce grown in Mexico by Taylor Farms, one of the largest fresh-produce suppliers for the U.S. Despite a false positive test, federal officials seem to have traced a significant portion of the outbreak to Taylor Farms. 
    • “Normally, cyclosporiasis cases annually peak between May 1 and Aug. 31. This year, a spike of illnesses had a June 26 onset date, according to the CDC. Michigan and surrounding states appear to be hardest-hit, with Michigan officials reporting 6,571 cases and 102 hospitalizations as of July 21, and Ohio logging 1,246 confirmed cases as of July 16.” 
  • The Washington Post reports,
    • “The United States has now reported the most measles cases in any year since 1991, not only surpassing all of last year’s record total, but also reaching the highest level in 35 years, with more than five months still remaining in 2026.
    • “The country reported 2,295 cases as of Tuesday, according to data from Johns Hopkins University’s U.S. measles tracker. The total surpasses last year’s 2,289 cases and is the highest annual count since the highly contagious disease was eliminated in the United States in 2000.
    • “The fact that we’ve reached this total this early in the year is really a reflection of those large outbreaks earlier in the year, particularly in South Carolina and Utah,” said William Moss, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. “It’s very frustrating. This is a reflection that we have been unable to stop measles virus transmission in this country.” * * *
    • “The latest milestone underscores how the country has entered a new phase in its battle with measles, with repeated new infections of the deadly disease igniting sustained outbreaks in multiple states rather than staying concentrated in a few undervaccinated communities.”
  • The American Medical Association lets us know “6 things patients should know about red light therapy.”
    • Does red light therapy really work for wrinkles, hair growth and to boost skin health? The latest “Health vs. Hype” episode explores the facts.
  • The Wall Street Journal points out,
    • “Architect Lloyd Alter states dangerous bathroom designs cause falls, the leading injury-related death for adults aged 65 and older.
    • “Freestanding bathtubs and shower-tubs are dangerous due to slippery surfaces, thin edges and a lack of grab bars.
    • “Toilets also present fall risks due to straining and high “comfort height” designs; grab bars and lower toilets are recommended solutions.”
  • STAT News relates,
    • “Europeans can now receive a device that can partially restore their vision loss. Americans may not have to wait long to get it, either.
    • “Science Corporation announced Wednesday that European regulators had approved the commercial sale of the startup’s retinal implant that improves eyesight for patients with age-related macular degeneration in their central vision, enough to read books and road signs more clearly. 
    • “We have a cochlear implant for vision now,” said Science founder and CEO Max Hodak.
    • “The implant, called PRIMA, also received a Humanitarian Use Device designation from the FDA in March, which puts the device on track to debut in the United States early next year if it receives agency approval. If it hits this milestone, PRIMA would be the second brain-computer interface (BCI) to enter the U.S. market.” * * *
    • “The Science device’s impact could be substantial. Geographic atrophy accounts for 20% of all legal blindness due to age-related macular degeneration and affects more than 1 million people in the U.S. PRIMA received FDA’s special designation because Science intends to initially use it for only the most severe cases of atrophy, which affects fewer than 8,000 people per year.” 
       
  • MedPage Today notes,
    • “Five adverse pregnancy outcomes were independently associated with increased peripheral artery disease (PAD) risk later on.
    • “These associations remained in co-sibling analyses, suggesting that familial factors are not to blame.
    • “Women with adverse pregnancy outcomes should have lifelong clinical follow up.”
  • Per Health Day,
    • “Cognitive function, manual dexterity, and breathing ability all play an important role in helping people with chronic obstructive pulmonary disease (COPD) use their inhalers correctly, according to a study published online May 27 in the Annals of the American Thoracic Society.”
  • Per BioPharma Dive,
    • “A genetic medicine from Arrowhead Pharmaceuticals has succeeded in two late-stage clinical trials focused on a condition that increases the risk of sudden, potentially life-threatening cases of pancreas swelling.
    • “The medicine, known as plozasiran, is a small piece of synthetic RNA designed to lower fat levels in the bloodstream. It does this by degrading the instructions cells use to create a protein that slows down triglyceride metabolism. Plozasiran is already approved, and sold under the brand name Redemplo, as a treatment for a rare disease that leads to extremely high levels of triglycerides. Arrowhead, though, is trying to expand the drug’s use.
    • “Positive results released Wednesday should help in that mission. Across the two trials, which enrolled adults with “severe hypertriglyceridemia,” an under-the-skin injection of Arrowhead’s drug once every three months respectively cut median triglyceride levels by 79% and 81% after one year. The reduction seen in placebo-treated patients, meanwhile, was around 27%.”

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

  • Beckers Payer Issues reports,
    • “Molina Healthcare reported $60 million in net income for the second quarter of 2026, a 76% year-over-year drop from $255 million.
    • “The insurer attributed the decline mainly to lower premium revenue and a higher medical loss ratio. Total revenue for the quarter was nearly $10.9 billion, down 4.8% year-over-year. 
    • “Even with the profit decline, Molina raised its full year 2026 adjusted earnings guidance to at least $5.25 per diluted share, up from at least $5, and lifted its GAAP guidance to at least $2.15 per share. The company said a $1.50 per share improvement in its Medicare business was offset by an equal decline in its ACA marketplace business, and that without the marketplace reduction, full year adjusted guidance would have risen to $6.75 per share.
    • “Molina’s MLR in Q2 was 92.2%, up from 90.4% in the second quarter of 2025. The company had approximately 4.9 million members as of June 30, down from 5.7 million a year earlier. Marketplace membership fell to 283,000, from 655,000 at the end of 2025 and 690,000 a year ago. The company tied the decrease to its pricing and product strategy, the expiration of enhanced ACA subsidies and new program integrity measures.”
  • Fierce Healthcare relates,
    • “Community Health Systems fell short of the market’s earnings and revenue expectations during its second quarter, posting a loss when excluding funds received for its recent hospital divestitures. 
    • “The for-profit reported Wednesday after market close net operating revenues of $2.83 billion. Net income attributable to stockholders was $70 million, or 50 cents per diluted share, but fell to a 19 cents per diluted share loss after excluding the facility sales and other adjusting items.
    • “The reported revenue and adjusted earnings are about $70 million and nine cents per share behind analysts’ estimates, per Seeking Alpha.
    • “The latter also outpaces the five cents per share net loss the system had logged for the same period last year, despite a same-store net operating revenue increase of 2.4% and same-store admissions and adjusted admissions gains of 1.9% and 2.9%. 
    • “The company primarily attributed the year-over-year performance decrease to “an unfavorable change in payor mix and higher medical specialist fees.” These were offset by improved volumes, higher reimbursement rates, greater net benefit from supplemental reimbursement programs and tighter contract labor and professional liability expenses, according to the release.”
  • and
    • “Visana Health, a virtual women’s health provider, has redesigned its annual visit to be more comprehensive and personalized.
    • “Visana’s Complete Women’s Health Visit combines preventive care, symptom evaluation and expertise across gynecology, primary care and endocrinology to tailor care to each patient. The telehealth visits are 45 minutes long and go beyond a pap smear and mammogram to include hormonal, metabolic, cardiovascular, reproductive, sexual and emotional wellbeing assessments. 
    • “It’s really a tailored visit to the individual and then optimized for what her risks are and what her questions are,” Barbara Levy, M.D., chief medical officer at Visana, told Fierce Healthcare.”
  • Beckers Hospital Review tells us,
    • “Seven hundred rural hospitals across the U.S., or about one-third of all rural facilities in the country, are at risk of closing due to severe financial challenges, according to a July 21 Center for Healthcare Quality and Payment Reform analysis.
    • “The analysis comprises 264 hospitals that are at immediate risk of closure, according to the report. In almost every state, rural hospitals are at risk of closure. In most states, more than 25% of rural hospitals are at risk and in 11 states, 50% or more are at risk.
    • “The latest data is a slight decrease from CHQPR’s May analysis, which found 720 hospitals were at risk of closure with 294 at immediate risk. 
    • “More than 100 rural U.S. hospitals have closed in the past decade, with 110 closing since 2015, according to the report. Fifty-three hospitals have ended inpatient services since the beginning of 2023 to qualify for federal grants only available to rural emergency hospitals.”
  • The Cotiviti consulting firm discusses fraud, waste and abuse in behavioral health care.
    • “Behavioral health continues to be shaped by expanding access, evolving care delivery models, and regulatory change. While these advancements have improved patient access to critical services, they have also introduced new complexities for payers working to maintain program integrity and reduce fraud, waste and abuse (FWA) risks.
    • “For health plans, particularly those serving Medicaid and other government-sponsored populations, identifying emerging billing patterns, strengthening review processes, and aligning internal teams around consistent standards can help reduce financial leakage while supporting appropriate care delivery.”
  • Beckers Hospital Review points out,
    • “GLP-1 medications are linked to a 17.3% drop in long-term sickness leave over four years, according to a working paper published in July by the National Bureau of Economic Research.
    • “Researchers compared 7,011 patients who started Ozempic during the drug’s first 17 months of availability to a matched group of 7,011 patients who initiated treatment four years later.”
  • and
    • “Where the GLP-1 compounding fight stands: 5 things to know.”
  • Per Fierce Healthcare.
    • “Samsung rolled out a beta version of its artificial intelligence-powered personal health assistant on Tuesday.
    • “The new AI assistant—dubbed Samsung Health Assistant—is embedded into the Samsung Health app and is currently available to eligible users across the U.S. It allows users to ask health questions and receive personalized guidance and recommendations through its “unique knowledge base.” Insights have been validated by a team of physicians and certified health coaches, executives say.
    • “Our new Health Assistant advances Samsung’s vision for Connected Care by giving users a deeper understanding of their mind and body through daily health monitoring and increasing opportunities for early detection,” said Hon Pak, M.D., senior vice president and head of the digital health team at Samsung Electronics, in a statement.”

Noteworthy Event

  • The Washington Post reports,
    • “An Australian woman gave birth to identical quadruplet girls last week, all from one fertilized egg that split into four.
    • “The chance of conceiving monozygotic quadruplets is 1 in 15 million, said Alexa Bendall, a maternal fetal specialist, in an interview released by Royal Brisbane and Women’s Hospital in Queensland. 
    • “The girls are named Emily, Harriet, Catherine and Alexa — in the doctor’s honor. 
    • Triplet and quadruplet pregnancies are high risk for complications for the mother and children throughout gestation, compared with twins, according to scientific research by Cambridge University Press.
    • “From an academic perspective, it’s really interesting,” Bendall said. “From a human perspective, to be able to be part of the family’s journey and come out with four beautiful babies and a healthy mum is very precious.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • The Washington Post tells us,
    • “The House passed a stopgap bill to fund the government into December in an effort to avoid another government shutdown weeks before the midterms, but the effort faces an uphill climb in the Senate.
    • “The resolution, which would fund the government through Dec. 4, passed 220-205. 
    • “House Speaker Mike Johnson (R-Louisiana) pushed the measure to preempt a showdown with Democrats in the fall over government funding as lawmakers are unlikely to meet a Sept. 30 deadline ahead of the new fiscal year.” * * *
    • “Senate Majority Leader John Thune (R-South Dakota) said he’ll bring a bipartisan agreement to fund the government to the floor before the August break. That measure would then need to be approved by the House when lawmakers return at the end of August before it goes to Trump’s desk.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) today deferred more than $1 billion in federal Medicaid payments to California and Minnesota as the states submit additional documentation supporting certain high-risk Medicaid claims. The action advances the Trump administration’s effort to combat fraud, waste, and abuse in Medicaid and safeguard federal taxpayer dollars.” * * *
    • “CMS is deferring approximately $867.5 million in federal Medicaid payments to California and $199 million to Minnesota after focused financial reviews identified claims that require additional review before federal matching funds are released. These are payment deferrals (not permanent funding cuts) and both states will have the opportunity to provide documentation showing the claims meet federal Medicaid requirements.
    • “Additionally, under Secretary Kennedy’s direction, HHS and the HHS Office of Inspector General continue to exercise exclusion authorities as a critical tool to remove bad actors from Medicare and Medicaid programs — and, in many cases, permanently bar them from returning.”
  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services today released a proposed rule that would update Medicaid provider tax policies included in the July 2025 reconciliation law and change how the agency determines whether certain healthcare taxes comply with federal requirements. States commonly use provider taxes to help finance Medicaid. CMS said the proposed changes are intended to ensure those taxes are not structured in a way that effectively guarantees providers receive their tax payments back. 
    • “The proposal would replace the current 6% indirect hold harmless threshold with state- and provider class-specific thresholds based on taxes enacted and imposed as of July 4, 2025, and would implement a phased reduction in allowable thresholds for Medicaid expansion states beginning in fiscal year 2028. The rule proposes revised interpretations of “enacted” and “imposed” taxes as described in CMS’ preliminary guidance issued Nov.14, 2025. CMS also proposes to sunset the current alternative “75/75” compliance test and establish a new provider tax class, “Services of Health Insurers,” bringing existing state taxes on health insurers under CMS oversight. 
    • “Comments are due 60 days after publication in the Federal Register.” 
  • Govexec relates,
    • “The Office of Personnel Management is set to propose new rules this week implementing a 2022 law aimed at reforming retirement benefits for federal first responders who are injured during their service and forced to pursue jobs elsewhere in government.
    • “Federal workers in professions like law enforcement and firefighting participate in the federal government’s defined benefit retirement program on an accelerated basis—in exchange for paying more toward their pensions each paycheck, they become eligible for their full annuity once they have served 20 years and reached age 50. They are also subject to mandatory retirement at age 57.
    • “But if a federal first responder is injured on the job and unable to continue in their current role, they lose access to the accelerated retirement timeline, despite the increased payments they have already made along the way.
    • “A proposed rule set for publication Wednesday in the Federal Register would implement the First Responder Fair RETIRE Act, a 2022 law aimed at fixing this flaw. The legislation allows first responders forced to take a job elsewhere in the federal government to continue to pay accelerated contributions and reach retirement when they originally planned. And it grants feds the chance to be refunded the extra half-percentage point of their salary that went toward retirement if they leave federal service altogether prior to reaching retirement age.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA added eight new members to an advisory committee slated to review whether pharmacies can legally market peptides, after criticism the panel is stacked with those tied to peptide-related businesses and clinics.
    • “The panelists were added as temporary voting members to the Pharmacy Compounding Advisory Committee, which is scheduled to convene Thursday and Friday to evaluate whether seven unapproved peptides can be reclassified to allow pharmacies to legally manufacture them. The committee will consider whether to reverse a 2023 Biden-era decision that nearly 20 peptides pose safety risks and can no longer be legally compounded.
    • “The temporary members include clinical researchers, professors of medicine, and pain and substance use experts.
    • “They seem considerably more qualified and less conflicted than the others who were added recently,” Peter Lurie, a former FDA associate commissioner, now the president of the Center for Science in the Public Interest, said in an email. “The new members are mostly confined to certain peptides, not the case for the earlier nominees.”
  • MedTech Dive relates,
    • “Philips received 510(k) clearance for a new version of its pulse oximeter clip sensor that the company says is accurate across a broad range of skin tones. 
    • “The reusable clip sensor has optical refinements to improve signal quality and measurement consistency and support reliable oxygen saturation measurements across diverse patient populations and clinical conditions, the company said in the Tuesday announcement. 
    • “Medtech firms have sought to update their pulse oximetry technology after several studies raised concerns about the devices being less accurate for people with dark skin pigmentation. The Food and Drug Administration issued updated testing recommendations for pulse oximeters in a 2025 draft guidance, but has not finalized it.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The U.S. District Court for the District of Columbia July 21 upheld a lower court’s decision that Section 340B of the Public Health Service Act does not permit drug companies to impose proposed rebate models on 340B purchasers unless the Secretary of the Department of Health and Human Services approves. The court did not weigh in on the lawfulness of the department’s proposed rebate program or any other version of a rebate model that it could approve.  
    • “The manufacturers’ reading would also counterintuitively let manufacturers, rather than the Secretary, take the lead in administering the 340B Program, rendering the Secretary’s role largely reactive,” the court explained. “Put simply, the statute places the Secretary, not the manufacturers, in the driver’s seat of this important program.” 
  • FEHBlog observation: By upholding a lower court’s decision, the article is referring to an initial decision by a Magistrate Judge.
  • BioPharma Dive relates,
    • “Novo Nordisk is suing its biggest obesity drug rival, alleging on Tuesday that Eli Lilly is engaging in deceptive advertising by intentionally using outdated studies to compare the higher doses of its medicines to lower doses of Novo’s products.
    • “Filed in a New Jersey [U.S.] District Court, the lawsuit follows a cease-and-desist order in which Novo asked Lilly to take down the advertisements. Lilly hasn’t, so the Danish drugmaker is seeking a permanent injunction to get the ads pulled and for Lilly to “conduct a corrective advertising campaign.” Lilly countered in a statement that the advertising is “truthful, it is transparent, and it is grounded in the most direct scientific evidence available.”
    • “The lawsuit comes as Lilly has gotten the upper hand in a high-stakes battle for market share. Lilly’s medicine, Zepbound, recorded $4 billion in sales in the first quarter of 2026 compared with the 18.2 billion krone, or $2.7 billion, generated by Novo’s Wegovy. The turf war escalated this year with both companies launching obesity pills that could extend the reach of weight-loss medicines.”
  • Per a Department of Justice news release,
    • “A foreign national was arrested yesterday on criminal charges related to his orchestration of a scheme to defraud Medicare over half a billion dollars for unnecessary genetic testing.
    • “Khalid Satary, 54, was charged by indictment in 2019 in the Eastern District of Louisiana as part of one of the largest health care fraud schemes ever charged by the Department of Justice. According to the indictment and court documents, from 2016 to 2019, Satary owned and operated several diagnostic testing laboratories throughout the United States that billed Medicare for expensive and medically unnecessary genetic tests. Satary allegedly conspired with dozens of patient recruiters, telemarketing call centers, and telemedicine companies to utilize deceptive marketing campaigns and illegal kickbacks and bribes to generate cancer genetic test samples that reimbursed between $10,000 to $20,000 per sample. Through his laboratories, Satary billed Medicare for over $547 million. He also allegedly paid millions of dollars in illegal kickbacks and bribes to doctors and patient recruiters. In connection with the indictment, the government seized 16 bank accounts and restrained real estate from Satary.”

From the public health and medical / Rx research front,

  • Phrma reports,
    • “A new study published in The Lancet offers some of the strongest real-world evidence to date that vaccination against human papillomavirus (HPV) is saving lives.” * * *
    • “Researchers say these findings indicate that eliminating cervical cancer is now an achievable goal. But that progress depends on maintaining timely and high vaccination rates with policies that support coverage and access to vaccines.
    • “The new findings, drawing on population-level disease surveillance, show that HPV vaccination is changing what is possible in cancer prevention.
    • “Policymakers should support policies that preserve access and help ensure families can get recommended vaccines without unnecessary barriers.”
  • Medscape adds,
    • More than 80% of patients with early Alzheimer’s disease (AD) treated with lecanemab (Leqembi, Eisai/Biogen) in routine practice remained clinically stable or improved over an average of 17 months of treatment, an interim analysis of the real-world LEADER study showed.
    • The real-world safety profile of the antiamyloid therapy was consistent with the drug’s US prescribing information, with most amyloid-related imaging abnormalities (ARIA) being asymptomatic and mild.
  • The AP relates,
    • “Road deaths are declining in the U.S. and worldwide, but lower-income countries aren’t experiencing much of the improvement, according to a study published Monday.
    • “Global rates of road injuries and deaths each fell more than 30% between 1990 and 2023, according to the study published in Lancet Public Health, which noted the progress varied from country to country.
    • “Pedestrian and vehicle occupant deaths rose over that time in six countries — including the United States. However, more recent data shows road deaths fell in the U.S. in 2024 and 2025.”
  • The New York Times tells us,
    • “Diet is one of the most important factors shaping health, but it’s surprisingly difficult for researchers to figure out what people eat.
    • “Researchers’ usual tools, like food frequency questionnaires or asking people to recall what they ate the day before, are tedious and expensive, said Christopher Gardner, a nutrition scientist at Stanford. Such efforts depend on people being candid and accurate; people forget about 15 to 20 percent of what they ate after a few days.
    • “It’s one of the reasons that nutrition research is so difficult and why the best evidence comes from small metabolic chamber studies, Dr. Gardner said. In such studies, researchers essentially “incarcerate someone,” he added. “They can’t leave. You cook the food for them, you slide it under the door, you know if they didn’t finish it.”
    • ‘But a new study, published today in the Proceedings of the National Academy of Sciences, points to a treasure trove of nutrition data: sewage. Using wastewater in North Carolina, researchers searched for traces of food DNA that had survived digestion. For less than a penny a person, they identified hundreds of foods that had been consumed — like chocolate, lettuce, turkey, blueberries, black pepper — and could even infer the socioeconomic profile of a community.”
  • The Wall Street Journal informs us,
    • “When Molly Taylor started taking Mounjaro in the fall of 2024, she marveled at the speed of results. She wasn’t overweight, but she hadn’t been comfortable in her body. Now, she could eat whatever she wanted, just in smaller portions, and people were complimenting her looks. She no longer felt self-conscious. 
    • “Then her mindset began to shift. 
    • “I gradually started to worry about what I was eating, how many calories were in it, if it was going to stop me from losing more weight,” said the 23-year-old nanny, who is studying to be a nurse in London. “I think that’s when I was starting to develop anorexia.” 
    • “GLP-1s have been hailed as miracle drugs, their rise leading to critical breakthroughs in America’s fight against obesity. Roughly 13 million Americans are now on them, according to research from JPMorgan published in February. The drugs mimic naturally occurring hormones to suppress appetite and cravings and make people feel full. For those who’ve struggled with restrictive eating and anorexia, that can be a tantalizing proposition—and a dangerous one. 
    • “Anorexia kills a higher percentage of patients than any other eating disorder, and it is the second most deadly mental illness after opioid addiction, according to data compiled by the nonprofit National Association of Anorexia Nervosa and Associated Disorders.”
  • Cigna Healthcare, writing in LinkedIn, points out,
    • “Mental health challenges rarely arrive as a single, dramatic moment. More often, they accumulate quietly—sleep gets lighter, patience gets shorter, motivation slips, and everyday tasks start to take more effort than they used to. People may still be showing up and getting things done, but with less ease, less connection, and lower reserves.
    • “Telehealth and evidence-based mental health apps can make care easier to access and easier to stick with. When support fits more naturally into real life, people are more likely to seek help sooner. That often shows up at work as steadier attention, clearer communication, more consistent follow-through, and fewer days of simply pushing through.” * * *
    • “Telehealth and mental health apps won’t solve every problem, but they can make it easier to get help sooner and stay with it. For many common needs, the evidence suggests remote therapy can be as effective as in-person care, and structured digital programs can reinforce skills between sessions. In practice, that can make day-to-day life feel more manageable.”
  • MedPage Today offers us “The Roadmap to DSM-6 — A look at conflicts of interest in the formation of psychiatry’s playbook.”
  • Health Day notes,
    • “Snoring at night might not just disrupt a partner or pets; it could also impact memory function and dementia risk.
    • “A new study in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Associationexamined the link between obstructive sleep apnea (OSA), memory and dementia risk. Researchers used cognition testing on adults aged 40 to 77 to compare people with and without the sleep disorder.
    • “Those with untreated OSA had worse cognition and memory function. They also had an increased dementia risk. 
    • “If the sleep apnea was treated, however, that changed. Adults who managed their apnea had brain testing results on par with adults without it.”
  • Per Radiology Business,
    • “A significant number of incidental breast masses are overlooked on CT scans of the chest, which could potentially lead to delays in diagnosis and treatment, researchers caution. 
    • “A new Academic Radiology analysis of incidentally detected cancers suggests that up to two-thirds of visible breast masses on emergency chest CTs go unnoticed by readers. At once center, such misses resulted in significant delays in cancer diagnosis, up to 33 months in some cases.  
    • “Although emergency chest CT scans are usually completed for other clinical indications, experts involved in the study say they present an opportunity to catch cancer earlier. However, visible lesions on these scans often are overlooked. 
    • “In recent years, especially with the COVID-19 pandemic, a significant increase in CT use in emergency departments has been observed,” Olgun Sahin, MD, with the Department of Radiology, Izmir City Hospital in Turkey, and colleagues explained. “The increasing number of chest CT scans is assumed to lead to a corresponding increase in the detection of incidental breast cancers. However, despite this increased detection potential, published data on clinical practice is striking. A retrospective study by Park et al. revealed that 64.3% of incidental breast cancers were missed in initial chest CT reporting. Similarly, Abougazia et al. recently reported 67.9% of such cases.” 
  • Per Fierce Pharma,
    • “Detailed phase 3 results suggest the two-drug combination of Gilead Sciences’ lenacapavir and Merck & Co.’s islatravir has what it takes to become the first complete weekly pill for the treatment of HIV.
    • “Two Islend clinical trials confirmed that a once-weekly, single-tablet combination of islatravir and lenacapavir (ISL/LEN) matches daily treatments like Gilead’s Biktarvy at maintaining HIV viral suppression, according to data slated for presentation at the 26th International AIDS Conference in Rio de Janeiro, Brazil. 
    • “Positioned to become the first complete weekly oral HIV treatment, ISL/LEN combines a major scientific leap with the promise of meeting diverse patient needs, Jared Baeten, M.D., Ph.D., Gilead’s clinical development lead in virology, said in an interview with Fierce Pharma.”
  • Per BioPharma Dive,
    • “Agios Pharmaceuticals has decided not to further develop one of its more closely watched medicines as a treatment for sickle cell disease due to disappointing results from a mid-stage clinical trial.
    • “The drug, called tebapivat, “did not demonstrate the level of differentiation required to support continued development,” Agios said in a statement. Tebapivat has been billed as a “next-generation” version of another Agios medicine, mitapivat, which is already approved for use in two blood disorders. These drugs work by activating the “pyruvate kinase” enzyme that’s essential for the health and survival of red blood cells.”

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

  • Modern Healthcare reports,
    • “Hospital systems are improving care transitions to help offset an expected decline of post-acute providers. 
    • “Systems are preparing for fewer post-acute referral partners, which could increase their costs, reduce revenue and slow patients’ recovery after a hospital stay. Home health, skilled-nursing, rehabilitation and hospice facilities are the focus of a sweeping fraud crackdown that has stripped some post-acute providers of their Medicare eligibility. Also, in May, the Centers for Medicare and Medicaid Services announced a six-month moratorium on new Medicare enrollment of hospices and home health agencies.
    • “The increased oversight threatens to exacerbate persistent inpatient discharge delays that are limiting access to care. Hospital systems have not experienced additional care transition hurdles yet, and executives hope expanding workforce strategies and new technology will blunt any impact.”
  • Fierce Healthcare relates,
    • “Nonprofit health systems AdventHealth and Intermountain Health announced plans Tuesday to bring Denver-area hospitals and ambulatory sites under a new, to-be-formed joint venture. 
    • “The pair have signed a letter of intent and expect to have a definitive agreement in hand “in the coming weeks” as they pursue an early 2027 close. 
    • “The proposed entity would comprise eight hospitals—five from AdventHealth and three from Intermountain—as well as “dozens” of their affiliated medical practices, clinics, urgent care and emergency centers. These represent the entirety of AdventHealth’s presence in the area, and all but one of Intermountain’s local hospitals (Intermountain Health Saint Joseph Hospital, in Denver, being the exception).”
  • and 
    • “Cardinal Health is pursuing two tuck-in acquisitions to expand its home care business.
    • “The pharmaceuticals and specialty products distributor announced on Monday it had agreed to buy AdaptHealth Corp’s diabetes health business unit and medical supply provider Strive Medical in separate deals worth $360 million.
    • “The deals will accelerate Cardinal Health’s at-home solutions’ growth strategy, the company said.”
  • and
    • “Amazon Pharmacy is collaborating with digital prescription platform eNAvvi to provide clinicians with real-time medication information and delivery options through its e-prescribing workflow.
    • “The partnership allows providers to see current pricing and stock for prescriptions, including cash pricing versus estimated insurance copays, and shows how quickly medications will reach patients, the companies said. The goal of the partnership is to support medication adherence and increase access for patients, especially for those in “pharmacy deserts.”
    • “eNavvi CEO Simon Chang said in a statement the collaboration “fundamentally changes what physicians can see and do at the moment of prescribing.”” 
  • The Wall Street Journal tells us,
    • “[The Swiss drug maker] Novartis returned to sales growth in the second quarter, reporting net sales of $14.41 billion.
    • “Core operating profit for Novartis was flat at $5.94 billion, beating analyst expectations of $5.31 billion.
    • “Novartis expects core operating profit to decline by a low single-digit percentage this year as it faces the worst patent cliff in its history.”
  • Healthcare Dive informs us,
    • “As employers grapple with worker demand for GLP-1 drugs for weight loss, 1 in 5 employers recommend employees use their FSA, HSA or integrated HRA to acquire them, according to new research from the International Foundation of Employee Benefit Plans.
    • “While most employers don’t cover GLP-1s for weight loss, many try to support workers in other ways, said Carey Wooton, associate vice president of education at the International Foundation; nearly three-quarters provide disease management and case management, more than 6 in 10 offer nutritional counseling, and a similar share cover bariatric surgery.
    • “Cost remains a major impediment to coverage. GLP-1s for weight loss represented 11.4% of annual claims for corporations in 2025, up from 6.9% in 2023, the report found.”
  • Alan Fein, writing in his Drug Channels blog, discusses “2025 Gross-to-Net Realities at Eight Top Drugmakers: The Net Pricing Drug Channel Emerges.”
  • MedTech Dive lets us know,
    • “Medtronic on Tuesday said it has developed an application for its Hugo surgical robot that enables the use of artificial intelligence to support decision-making during procedures.
    • “The Touch Surgery Aide platform incorporates Nvidia’s computing infrastructure and runs Medtronic’s AI application, called Instrument Exit Point, or IEP. The application has received Food and Drug Administration clearance, Medtronic said.
    • “Medtronic will offer an early look at the new platform this week at the Society of Robotic Surgery meeting in Florida.”