Weekend update

Congress

Weekend update

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Friday report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

No Surprises Act News,

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

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 7, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Based on multiple data sources, COVID-19 activity is low in many regions but is increasing in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The American Hospital Association reports,
    • “A study published Aug. 5 by Nature found that COVID-19 infection can reactivate dormant, chronic viruses such as Epstein-Barr and cytomegalovirus. The study found that reactivation is correlated with the severity of the COVID-19 infection. The study included data from more than 1,100 hospitalized patients with COVID-19 and found reactivation of various Herpesviridae and Anelloviridae viruses. Researchers said that reactivation occurred frequently in “immunocompetent” individuals during severe illness.”
  • The University of Minnesota CIDRAP relates,
    • “Working-age adults living with long COVID feel less satisfied with life, experience less happiness, and have less hope, according to a study published this week in BMC Public Health. The paper highlights the association between having long COVID and poorer wellbeing. 
    • “The findings underscore that the burden of long COVID extends beyond clinical health outcomes to encompass how individuals evaluate and experience their lives,” wrote the authors, from Syracuse University in New York.
    • “Long COVID symptoms were significantly associated with lower levels of subjective wellbeing in a dose-dependent manner.”  
    • “The World Health Organization defines long COVID “as the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation.”
  • and
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 94 new measles infections—most of them in Pennsylvania—bringing the US total for the year to 2,465, the agency said in its weekly update.
    • “The numbers likely provide additional data to move the United States toward losing its measles elimination status this year. The nation gained that distinction in 2000, but  has now logged consecutive years of more than 2,200 measles cases (2,289 for all of last year). This year’s total is the highest since 1991.”
  • The Washington Post tells us,
    • “Michigan health officials say new cases of cyclosporiasis are declining in the state hit hardest by an outbreak that has sickened more than 12,000 people and left two dead in the state since June. 
    • “The state’s health department said new case reports are slowing and diarrhea-related emergency department visits are trending downward. The drop in cases prompted officials to lift their broad recommendation to avoid bagged salad mixes. But Michigan continues to recommend avoiding recalled lettuce from Taylor Farms de Mexico sourced from central Mexico.
    • “Michigan officials said they believe most of their exposures took place in late June to early July and that most contaminated produce is probably no longer available for consumption.
    • “Cyclospora infections typically cause symptoms about seven days after exposure, although symptoms can take up to 14 days to appear. The health department said residents can now return to routine food-safety guidance for handling and consuming produce, including lettuce and salad greens.”
  • The AP informs us,
    • “In the past year, the U.S. has seen a jump in frequent marijuana users going to the hospital with a nausea and vomiting condition, according to a report released Thursday.
    • “The abruptness and sustained magnitude of the increase” is largely due to the condition getting its own diagnosis code last fall, which is providing a more accurate picture of what was an underrecognized problem, the authors of the U.S. Centers for Disease Control and Prevention report wrote.
    • “Hospital emergency room diagnoses of the condition, cannabis hyperemesis syndrome, rose 16% from last October to May of this year, federal researchers found.
    • “The syndrome — seen in people who frequently use marijuana, especially smokers — is characterized by recurring nausea, uncontrollable vomiting and excruciating abdominal pain.
    • “Past research has suggested that an estimated 2.75 million Americans suffer from it each year, and that hospital emergency room visits have been rising as daily recreational marijuana use has increased.”
  • MedPage Today points out,
    • “Maintaining three key health factors during midlife — normal blood pressure, no diabetes, and not smoking — was associated with nearly 13 additional dementia-free years, a study of 12,000 people in the U.S. showed.
    • “Individuals who met these criteria at age 55 lived an average 30.1 more years dementia-free, reported Josef Coresh, MD, PhD, of NYU Langone Health in New York City, and co-authors.
    • “Conversely, those who smoked, had hypertension, and had diabetes at age 55 had dementia-free survival of only 17.5 years, Coresh and colleagues wrote in Neurology Open Accessopens in a new tab or window.”
  • and
    • “Low-fat vegan diets can help aid in weight loss, but the mechanisms behind this have been unclear.
    • “Adults on a low-fat vegan diet reduced dietary energy density by 30% compared with controls in a secondary analysis of a randomized trial.
    • “Reductions in dietary energy density were significantly associated with greater weight loss after adjusting for overall energy intake.”
  • Medscape adds,
    • “Adding coronary artery calcium (CAC) scoring to risk estimates helped better identify adults at lower and higher risk for atherosclerotic cardiovascular disease (ASCVD) events. People with no detectable CAC had lower observed risk, while those with CAC had higher observed risk, especially when the decision about starting a statin was uncertain.”
  • Healio notes,
    • “Adults with type 2 diabetes and established CVD had lower risk for CV events with tirzepatide [a/k/a Zepbound] compared with sitagliptin [a/k/a Januvia].
    • “Tirzepatide decreased risk for infections leading to hospital admission.
  • Per Genetic Engineering and Biotechnology News,
    • “For people with severe food allergies, avoiding a trigger food like peanuts or tree nuts can mean constant vigilance. Approximately 8% of children and 10.8% of adults in the United States experience some type of food allergy. Even trace exposures can provoke reactions, and while oral immunotherapy can raise the threshold for some patients, the protection often depends on continued treatment and is associated with disease relapse in many patients. A new study suggests that another route to food tolerance may run through the gut microbiome.
    • “In a small Phase I open-label trial (NCT02960074), researchers at Boston Children’s Hospital tested whether oral encapsulated fecal microbiome transplantation (FMT) could safely increase peanut tolerance in adults with peanut allergy. The work, published in Science Translational Medicine, also used mouse models to probe how donor gut microbes might help restore oral tolerance. The study is titled, “Fecal microbiome transplant in food allergy in humans and mice identifies a role for bile acid metabolites in oral tolerance.”
  • The Wall Street Journal adds,
    • “Artificial-intelligence systems have been displaying some eye-opening new abilities in recent weeks: breaking out of their enclosures, hacking other companies, lying to people. 
    • “And now, for the first time, an AI model has created a new virus. A whole family of them, in fact. 
    • “In a study published in the journal Science, researchers at Stanford University and elsewhere said they successfully directed an AI model to create a collection of simple viruses that only infect bacteria and pose no threat to humans.
    • “In an interview, two of the authors said their research could help develop designer viruses that could be used to eliminate drug-resistant bacteria, which according to the World Health Organization kill millions of people every year.
    • “If we develop responsibly, I think it can lead to tremendous benefits in human health,” said Brian Hie, a computational biologist at Stanford and an author of the study.”

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

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

Thursday report

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

Simplicity is a virtue.

From of a Washington, DC

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

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

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

From the FDA front,

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

No Surprises Act News,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

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

Midweek report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the public health and medical/Rx research front,

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

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

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

Monday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend Update

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

Simplicity is a virtue.

From Washington, DC,

  • The Senate will remain in session this week for Committee business and floor voting on Capitol Hill while the House is already out on a District work break.
  • Of note,
    • Senate Finance Subcommittee on Health Care
    • August 4, 2026, 10:00 AM (EDT) – Senate | 215 Dirksen Senate Office Building, Washington, D.C.
    • Open Hearing: Hearings to examine building a resilient health care future with biotechnology.
    • Meeting Details
  • The Congressional Budget Office posted a report in which “CBO provides current information about the budgetary effects of drug provisions in the 2022 Reconciliation Act; the effects of drug price negotiation, inflation rebates, and the Medicare Part D redesign; and ongoing updates to CBO’s models.”
  • Last week, the Government Accountability Office posted a report pointing out its priority recommendations to the U.S. Office recommendations that remain open. Here’s the one that relates to the FEHB and PSHB Programs.
    • “Preventing improper payments. The Federal Employees Health Benefits (FEHB) program is the largest employer-sponsored health care program in the country. In fiscal year 2025, the FEHB program provided health insurance benefits to 8.2 million individuals at a cost to the government and enrollees of approximately $70 billion. OPM has overall responsibility for administering the FEHB program and for ensuring only eligible family members receive coverage. However, OPM has not yet implemented a monitoring mechanism to remove ineligible family members from the FEHB program, as we recommended. On July 4, 2025, legislation was enacted that directed OPM to implement this recommendation.4 By doing so, OPM could prevent improper payments, which OPM has estimated to be up to $1 billion annually.”
  • With all due respect to GAO, the biggest internal control gap in FEHB and PSHB eligibility is OPM’s failure to implement the HIPAA 820 standard enrollment roster transaction which would allow carriers to reconcile individual premium payments to each enrollee.
  • Govexec reports,
    • “The Office of Personnel Management moved Friday to finalize regulations that collectively seize jurisdiction over thousands of employee appeals, as the federal government’s dedicated HR agency moves to centralize power over the federal workforce.
    • Across three final rules slated for publication in the Federal Register Monday, OPM implemented plans to take over adjudication of federal workers’ appeals of reduction-in-force decisions and suitability actions, as well as cases involving employees still serving in a probationary period. A fourth rule overhauls RIF procedures more broadly, primarily by emphasizing recent performance reviews over tenure.
    • “Currently, a federal employee seeking to appeal an adverse personnel action stemming from a RIF, suitability decision or action that happened while they in their first probationary year of service does so by petitioning the Merit Systems Protection Board. Under the quasi-judicial agency’s jurisdiction, the employee’s case is heard by an administrative judge, with final review by the MSPB’s three-member board. Following a final decision by the agency, the employee—or their employing agency—can appeal to the U.S. Court of Appeals for the Federal Circuit.
    • “But under the new process, appeals would primarily be handled by OPM’s Office of Merit System Accountability and Compliance and ultimately reviewable by the OPM director. Employees would no longer be able to appeal final agency decisions in federal courts.
    • “In a blog post Friday [(Substack link)], OPM Director Scott Kupor said the MSPB is too slow to handle its current workload.”
    • “The current MSPB backlog stretches to many months and, in some cases, years,” Kupor wrote. “That is not good for employees who deserve timely resolution of their appeals and it is not good for agencies, which are left in management limbo while cases wind through a slow and costly adjudicatory process. Our proposed internal appeal processes are designed to be faster, more efficient, and, critically, structurally independent, with separate staff handling determinations and appeals.”

From the public health and medical / Rx research front,

  • Healio reports,
    • “About 36 million U.S. adults have chronic kidney disease, with increasing prevalence tied to diabetes, according to study data published in The New England Journal of Medicine. 
    • “National trends on the prevalence of CKD are limited by structural challenges, evolving eGFR equations and other constraints, according to Ashish Verma, MBBS,assistant professor of nephrology at Boston University Chobanian and Avedisian School of Medicine. Verma and Sophie E. Claudel, MD, a nephrology fellow at Boston Medical Center, aimed to quantify CKD prevalence using nationally representative data.”
  • The New York Times relates,
    • “The Best and Worst Habits for Your Liver
      • “Liver disease is on the rise worldwide. Your diet, workout routine and other health conditions can affect your risk.”
  • and
    • “What Doctors Want You to Know About Cervical Cancer Screening
      • “The guidelines have changed recently as new testing options have become available. Getting screened doesn’t have to be painful or confusing.”
  • Beckers Hospital Review tells us,
    • “Drugmakers have pushed back their resupply estimates for carboplatin, one of four chemotherapy drugs in a monthslong shortage, with some formulations now not expected to return until 2027.
    • “Cisplatin, carboplatin, oxaliplatin and ifosfamide, which form the backbone of treatment for breast, lung, ovarian, testicular, bladder, and head and neck cancers, remain in active shortage, according to updates posted by the American Society of Health-System Pharmacists.
    • “The ASHP and specialty groups are steering clinicians toward conservation strategies and patient-specific alternatives.” 
  • Medscape informs us,
    • “Patients’ willingness to continue to take an obesity management medication for weight-loss maintenance may wane if they believe that it is no longer working based on perceptions of diminished appetite control. Indeed, patients’ beliefs about medication effectiveness have been identified as a predictor of discontinuation. In light of these findings, patients could be counseled to expect a partial return of baseline appetite sensations after the first months of treatment, but, despite these changes, they will continue to eat less food. The continued reduction in food intake is required to maintain the new, reduced body weight, with its decreased energy requirements,” the authors of the study wrote.”

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

  • Healio reports,
    • “Executives from the largest U.S. health care payers cited proactive management of high-risk patients, biosimilar use and site-of-care steerage as their top tactics to lower care costs, according to a survey from Spherix Global Insights.
    • “Spherix surveyed 27 decision-makers from nine of the leading managed care organizations and pharmacy benefit managers (PBMs) in the United States: UnitedHealth Group, CVS Health, Cigna, Kaiser Permanente, Elevance Health, Humana, Health Care Service Corporation, Molina Healthcare, and Centene Corporation. The respondents included directors of pharmacy, planning and network strategy, along with vice presidents of pharmacy strategy and chief medical officers.”
    • “The purpose of this study is to get a deep understanding of the top nine payers in the U.S. market today and highlight how each approaches the market differently,” Sybil Mead, vice president of market access at Spherix Global Insights, told Healio. “The mixed quantitative and qualitative methodology is best to get us beyond the publicly available financial and other secondary-sourced information, to the nuance of strategy and outlook directly from the decision-makers’ perspectives.”
  • CIO relates,
    • “One of the biggest challenges companies like Aetna face every year is an annual HEDIS review of its records to identify gaps in care. For large national payors, the scale of the challenge is immense. So Aetna has deployed a gen AI-driven document intelligence platform that has reduced the need for manual review by 65%.
    • “We have a large group of amazing trained medical coders who do this every day,” says Nathan Frank, chief digital and technology officer at Aetna. “This is about making it easier for them by speeding up the process. Something that might have taken weeks or months we can now do in days.”
  • Beckers Payer Issues tells us,
    • “Members may not think they are talking to AI when they call their health plan, but the person assisting them might be.
    • “Some insurers have been leaning into member-facing AI capabilities. One of UnitedHealth Group’s 1,000 AI use cases has been using chatbots to handle customer calls, with an AI chatbot initially responding to more than 65 million calls in 2024.
    • “However, there has been a growing trend of AI quietly working behind the scenes on customer service calls, too. These tools aim to boost the member experience by increasing efficiency and accuracy.
    • “Stellarus is a healthcare technology company that spawned from a Blue Shield of California restructuring. Along with its tie to Blue Shield of California, Hawaii Medical Service Association and Blue Cross and Blue Shield of Kansas signed on as Stellarus co-founders, signaling Stellarus’ deep footprint with BCBS plans.
    • “The company just launched its AI-powered Customer Service Representative Chat for health plan staff. CSR Chat is the company’s first product in its Compass suite, an AI-driven engagement platform for health plans.
    • “CSR Chat helps put the right information in front of representatives at the right moment, enabling more consistent service, faster resolutions and better experiences for the people they support,” Vanessa Colella, PhD, president and CEO of Stellarus, said in a July 30 news release.”
  • Beckers Physician Leadership informs us,
    • “Physicians on RVU-based compensation plans often have no way of knowing whether the rate they are being paid is fair, and according to one gastroenterologist, that is often by design.
    • “The structural disconnect of wRVUs is well documented. Provider productivity, measured by wRVUs per FTE, has increased 7% since 2023, while provider compensation rose 6% and reimbursement declined 1%, as measured by net patient revenue per provider wRVU, according to Kaufman Hall’s “Physician Flash Report.” 
    • “Overall, wRVUs grew just 1.5% in 2024, down from 5.2% in 2023 and 18.3% in 2022, with the latter driven largely by evaluation and management coding changes, according to the AMGA 2025 Medical Group Compensation and Productivity Survey. Compensation, meanwhile, grew 4.9%. According to the report, about half of that compensation growth is being funded by physicians doing more work, not by gains in reimbursement.
    • “Rajiv Sharma, MD, a gastroenterologist and president of Phoenix-based Mirage Health, told Becker’s the per-RVU rate offered to physicians for identical work can vary drastically from one contract to the next.
    • “I’ve seen RVU rates range from $36 to $95 per RVU,” Dr. Sharma said. “It’s more fluctuation than anywhere else.”
    • “That spread is not accidental, he said.”

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.”

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • The New York Times reports,
    • “The Senate health ​committee on Thursday advanced the nomination of Dr. Erica Schwartz, President Trump’s pick for director of the Centers for Disease Control and Prevention, for a full Senate vote.
    • “The committee’s Republican members and Senator Tim Kaine, Democrat of Virginia, all voted in favor of her candidacy, with the remaining Democrats opposed.” * * *
    • “The committee on Thursday also voted to ​advance ⁠the nomination of Sean Kaufman for assistant secretary for preparedness and response, a role that includes oversight of emergency measures during public health crises.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services [(CMS)] July 30 released the fiscal year 2027 final rule for inpatient rehabilitation facilities. The rule will increase payments by 2.3% overall, which includes a 3.2% market basket update reduced by a 0.9 percentage point productivity adjustment. In addition, CMS updated the outlier threshold, which it says will increase overall payments by 0.4% in FY 2027.
    • “CMS also finalized two changes to the IRF coverage requirements. This includes a requirement that therapies be initiated within 36 hours of admission to the IRF and an initial interdisciplinary team meeting be held within four days of admission to the IRF. CMS did not finalize a third proposal that would have required the patient’s current functional status be documented on the preadmission screening. For the IRF Quality Reporting Program, CMS finalized a shortened timeframe for submitting program data.
    • “Changes are generally effective Oct. 1, 2026.”
  • Per a CMS fact sheet,
    • “On July 30, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-1851-F) that would update Medicare hospice payments and the aggregate cap amount for fiscal year (FY) 2027 under existing statutory and regulatory requirements.” * * *
    • “For FY 2027, CMS updated the hospice payment rate by 2.3% (an estimated increase of $755 million in payments from FY 2026). This figure results from the finalized 3.2% inpatient hospital market basket percentage increase reduced, as required by law, by a finalized 0.9 percentage point productivity adjustment. The finalized FY 2027 rates for hospices that do not submit required quality data information include the finalized FY 2027 hospice payment update percentage of 2.3% minus four percentage points as required by law, which would result in a 1.7% reduction over the previous year’s payment rate. These finalized payment rates reflect the most accurate, updated data available on the cost of goods, services, and labor.
    • “Hospice payments are subject to a statutory aggregate cap limiting the overall payments made to a hospice annually. The finalized hospice cap amount for FY 2027 is $36,174.75 (FY 2026 cap amount of $35,361.44 increased by the FY 2027 hospice payment update percentage of 2.3%).” 
  • Beckers Hospital Review shares 11 things to know about these new CMS rules.
  • U.S. Office of Personnel Management, writing in Substack, added another post to this Secrets of OPM blog titled “Plans are good, Execution is better.”
    • “Last year, I wrote about how the federal government needed to adopt a more disciplined approach to workforce planning. Every successful organization develops a thoughtful plan for the talent it needs to accomplish its mission. The federal government should be no different.
    • “Today, we’re taking the next step.
    • “The guidance OPM has issued to agencies on Annual Staffing Plans is about much more than compliance with a new planning process. It is about changing how the federal government thinks about hiring. Rather than defaulting to last year’s staffing levels or treating hiring as a series of isolated decisions, agencies will build comprehensive staffing strategies that begin with a simple question: “What workforce do we need to best serve the American people?””
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today issued an interim final rule removing references to the Uniform Guidelines on Employee Selection Procedures (UGESP) from OPM’s federal personnel regulations, bringing the agency’s regulations into conformity with the Department of Justice Office of Legal Counsel’s June 9, 2026, legal opinion concluding the Uniform Guidelines are unlawful and unconstitutional by encouraging race-conscious decision-making via “disparate impact” liability.
    • “The rule removes UGESP regulatory provisions while preserving longstanding federal requirements that employment practices be job-related, professionally developed, based on sound job analysis, and administered without prohibited discrimination.” * * *
    • “Federal hiring should be based on merit, qualifications, and the ability to perform the job,” OPM Director Scott Kupor said. “This rule ensures OPM’s regulations reflect legal guidance while preserving the rigorous, job-related standards that help agencies recruit and hire the most qualified workforce in service to the American people.”
    • “The interim final rule is effective upon publication in the Federal Register. OPM will accept public comments for 60 days before determining whether to revise, withdraw, or finalize the rule.”
  • NextGov adds,
    • “The General Services Administration on Wednesday celebrated the graduation of 71 U.S. Digital Corps fellows, marking the largest graduating class since the program’s inception. Those graduates updated the FedRAMP website, helped streamline Agriculture Department environmental reviews and supported other technology projects during their stints in the federal government.
    • “This government has starved for talent, for people who understand how to do all the things that we want to do to deliver better,” OPM Director Scott Kupor said during graduation remarks.
    • “Some of the graduates of the two-year fellowship program are continuing civil service while others are headed to the private sector.”
  • Tammy Flanagan, writing in Govexec, explains “Why time, not timing, is the biggest retirement advantage for federal employees.”
    • “A look at decades of market shifts and TSP data shows the biggest driver of retirement wealth isn’t picking the right stock. It’s starting early, contributing consistently and letting compounding do its work.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “A Food and Drug Administration advisory panel voted 10-3 Thursday for Replimune Group’s experimental melanoma therapy, after a contentious meeting in which experts raised doubts about whether the company’s data and trial design could be trusted to show the skin-cancer drug works.
    • “Thursday’s recommendation is the latest turn in a regulatory saga that has stretched nearly two years.” * * * 
    • “Thursday’s meeting came a day after another closely watched advisory session, in which FDA advisers voted against Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy—a rejection that, like Replimune’s, followed a prior FDA denial.” 
  • MedTech Dive relates,
    • “Artificial intelligence is here to stay at the FDA, but its integration and evolution may not be a straight line now that one of its biggest proponents, former commissioner Marty Makary, has stepped down.” * * *
    • “Acting commissioner Kyle Diamantas said AI remains a top priority for the FDA. Still, recent high-level departures, including Makary, Jeremy Walsh, chief artificial intelligence officer, and Sridhar Mantha, acting chief information officer, have raised questions about the future of AI implementation.
    • “It’s unclear now what the leadership and governance structure are around FDA-wide efforts,” said Tala Fakhouri, chief artificial intelligence and regulatory strategy officer at Parexel, and a former FDA AI policy official.”

No Surprises Act news,

  • Beckers Payer Issues reports,
    • “Another health insurance CEO is taking aim at the No Surprises Act’s arbitration system.
    • “We do support the overall strategic intent of consumer protection from surprise billing. However, we’re seeing some clear abuses of the IDR vehicle in practice,” Cigna Group President and CEO Brian Evanko said on the company’s second-quarter earnings call July 30, adding that the system is seeing “unsustainable volume levels, much of which is concentrated amongst a small number of providers.” 
    • “On July 22, a Wall Street Journal analysis of CMS data put 2025 arbitration payouts at nearly $15 billion, up from $4.08 billion in 2024, with arbitration firms collecting about $1.3 billion in fees. On the earnings call, Mr. Evanko referenced last year’s payout figure but said the impact “has been manageable” within Cigna’s insurance business.”

From the judicial front,

  • Fierce Healthcare reports,
    • “A federal judge has rejected a request from 26 states for a preliminary injunction in the Trump administration’s rollout of work requirements in Medicaid.
    • “The Centers for Medicare & Medicaid Services finalized implementation guidelines for states in June, with the eligibility requirements set to take effect on Jan. 1. States have until Aug. 31 to communicate with enrollees about the impacts of the changes.
    • “In an order issued Wednesday, Massachusetts District Judge Richard Stearns wrote that the states did not prove that establishing the systems necessary to make the eligibility determinations would cause them irreparable harm, as CMS said it would reimburse them for 90% of the costs for setting up those mechanisms.
    • :However, he said that the order does not reflect the court’s opinion on the merits of the broader litigation, which challenge provisions of the rule under the Administrative Procedure Act. Making a determination on that, as it questions whether officials hewed closely to Congressional intent in regulating the rollout of the requirements, requires a more complete picture.”
  • Healthcare Dive relates,
    • “The Federal Trade Commission is suing Hims & Hers [in a California federal court], alleging the telehealth company illegally shared sensitive health information with advertisers and misled customers about its billing practices. 
    • “The agency says California-based Hims & Hers made it difficult for users to cancel subscriptions, charged patients for medications before they consulted with a provider and shared their health data with third-party advertising platforms like Meta and Snap. 
    • “Hims & Hers called the FTC’s claims “baseless,” saying in a Wednesday statement that the agency “contorts the law to try to manufacture claims.”
  • Per a Justice Department news release,
    • “Access DX Laboratory, located in Houston, Texas, its former CEO Michael Stewart, and Florida businessman Harold Shatz, have each entered into settlements and will pay a combined total of $36.4 million to the United States to resolve allegations that they violated the False Claims Act (FCA) by paying kickbacks and billing Medicare and Medicaid for medically unnecessary genetic testing.
    • “The United States alleged that, from January 2018 through January 2020, Access DX, Stewart, and Shatz paid kickbacks to marketers in return for referrals of patients for genetic testing, unbundled billing codes for genetic testing, paid telemedicine providers for false and fraudulent doctors’ orders, and submitted and caused the submission of false claims for genetic testing.” * * *
    • “Except to the extent admitted by Stewart and Shatz in their plea agreements, the claims resolved by the settlement are allegations only and there has been no determination of liability.” 

From the public health and medical/Rx research front,

  • The AP reports,
    • “A first-of-its-kind U.S. study suggests invasive mold infections may be an underappreciated — and potentially deadly — threat.
    • “The researchers detected about 450 cases in Atlanta-area hospitals over five years. About a third of the patients died in the hospital.
    • “The findings, published this week by the U.S. Centers for Disease Control and Prevention, come from an attempt to better gauge how common these kinds of illnesses are. The government does not require doctors to report the illnesses.
    • “It’s kind of the first time we’ve had an estimate like this,” said the CDC’s Dr. Jeremy Gold, the study’s senior author.”
  • 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 launch of The Real Food Show, a new cooking series designed to help Americans prepare healthy, affordable meals using real, everyday ingredients.
    • “More than a cooking show, The Real Food Show is a national initiative that empowers families to make healthy eating practical, approachable, and affordable. Each episode combines simple recipes with the science behind them, translating the new Dietary Guidelines for Americans into meals that Americans can prepare in their own kitchens.”
    • “Visit The Real Food Show webpage for more details.”
  • Radiology Business tells us,
    • “Adult CT radiation doses have decreased substantially over the last decade in the U.S., according to new research published Tuesday. 
    • “About 10 years have passed since data underlying the most recent national benchmarks for radiation dosing were collected. This underscores the need for updated reference values, as these guidelines may not reflect new advances in scanner technology, reconstruction methods and protocol changes, experts write in RSNA’s Radiology. 
    • “Researchers recently aimed to address this information gap, analyzing adult CT acquisitions performed across U.S. facilities in 2025. They discovered clear progress, with CT diagnostic reference levels declining an average of nearly 22% since 2014.
    • “The magnitude and consistency of these reductions across examination categories suggest that such advances have translated into measurable, population-level dose reductions in routine clinical imaging in the United States,” Kalpana M. Kanal, PhD, with the Department of Radiology at the University of Washington, Seattle, and colleagues wrote July 28.”
  • The July 30 issue of NIH Research Matters covers the following topics:
    • Tracking diets via wastewater
      • “Measuring DNA from food in wastewater could provide snapshots of dietary patterns.
      • “Monitoring these patterns could be a powerful tool for informing nutrition policy.” 
    • Lung tumor signals may tamp down food intake
      • “Researchers found that a high-fat diet in mice amplifies nerve signals between certain lung cancers and the brain, leading to reduced appetite and weight loss.
      • “If confirmed in further studies, the results could inform strategies to improve nutrition and survival in certain patients with cancer.”
    • Bacteria share proteins to survive antibiotics
      • “Researchers found that some bacteria share proteins that help others survive antibiotics.
      • “The study suggests a novel approach that may help treat persistent bacterial infections.”
  • MedPage Today informs us,
    • “Consuming less sugar before birth and during the first 1 to 2 years of life was tied to a lower risk of dementia decades later, U.K. Biobank data showed.
    • “The study used the abrupt end of World War II rationing as a natural experiment to test whether early-life sugar exposure was associated with late-life dementia.
    • “Previous research has linked early-life sugar rationing to less risk of diabetes and hypertension in adults and better cardiovascular outcomes.”
  • Health Day adds,
    • “Want to give your tot a brain boost when it comes to learning language?
    • “Maintain eye contact as much as possible when you’re talking to them, a new study suggests.
    • “Eye contact helps a baby decide what is important, acting as a switch that triggers synchronization of their brain waves with those of the speaker, researchers reported recently in the journal Nature Communications.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “An international team of researchers has identified multiple new genetic risk factors associated with fibromyalgia, a syndrome characterized by widespread pain and tenderness, fatigue, and problems with sleep, memory and mood.
    • :The team analyzed genetic data from more than 2.5 million adults, of which 55,000 were fibromyalgia patients. They identified DNA sequence variants in 26 regions of the genome that affect the risk of developing fibromyalgia. Many of the genes implicated in these regions are involved in brain and nerve function.
    • “The results provide the strongest evidence yet that fibromyalgia is primarily a nervous system disorder rather than an autoimmune disease, as has long been debated. “This work changes how we think about fibromyalgia at a fundamental level,” said Michael Wainberg, PhD, an investigator at the Lunenfeld-Tanenbaum Research Institute, part of Sinai Health, and the University of Toronto. “For decades, patients have been dismissed or told their pain is simply psychological. Our findings confirm the condition has a clear biological basis.”
    • “Weinberg is co-senior author of the researchers’ published paper in Nature Medicine, titled “The genetic architecture of fibromyalgia across 2.5 million individuals,” in which they concluded, “This study provides robust genetic evidence defining fibromyalgia as a central nervous system disorder, thereby establishing a biological framework for its complex pathophysiology and extensive clinical comorbidities.”
  • Fierce Pharma points out,
    • “Investors anxiously waiting for Bristol Myers Squibb’s key Alzheimer’s disease psychosis readout for Cabenfy will have to wait a little longer. The company has once again delayed the expected phase 3 data from its Adept trial program, even as it delivered a group-wide quarterly beat that’s driving a significant forecast raise. 
    • “Rather than readouts in 2026, BMS now expects data from the three Adept trials to arrive beginning in early 2027 and be “spread across the year,” CEO Chris Boerner, Ph.D., said on the company’s earnings call Thursday.
    • “The delay was attributed to slower enrollment in the Adept-2 and Adept-4 studies and slower relapse event accrual in Adept-1, Boerner explained. Adept-1 could undergo an interim analysis as early as later this year, and BMS also plans to share safety and efficacy data this year from the trial’s open-label lead-in portion, he added.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna’s employer-sponsored plans reaped higher profits than expected in the second quarter after hiking premiums, spurring the company to raise its earnings outlook for 2026.
    • “Cigna results released Thursday are a relief for investors worried about broader pressures in the employer-sponsored market, which covers the majority of U.S. adults and has been a buoy for insurers slammed with higher spending in government programs in recent years.” * * *
    • “Cigna’s health services division Evernorth — which includes Express Scripts, one of the largest pharmacy benefit managers in the U.S. — brought in $1.7 billion in operating income in the quarter, down 2% year over year despite revenue growth.”
  • Modern Healthcare adds,
    • “The weight-loss drug boom is beginning to show signs of a slowdown as employers and insurers pull back on coverage, signaling the market could be entering a more restrained phase after years of breakneck expansion.
    • “In the past few months, growth in prescriptions for GLP-1 drugs for weight loss like Novo Nordisk A/S’ Wegovy and Eli Lilly & Co.’s Zepbound have moderated, according to Cigna Group Chief Executive Officer Brian Evanko. The insurer’s unit that manages drug benefits has noted coverage declines and slower utilization growth compared to prior periods, executives said during an earnings call with Wall Street analysts Thursday.”
  • Optum Rx, writing in LinkedIn, discusses “how plan sponsors can stay ahead of the latest drug cost trends.”
  • Fierce Healthcare relates,
    • “Teladoc Health trimmed its 2026 revenue outlook as its virtual behavioral health unit, BetterHelp, faces revenue pressure with consumer demand for insurance-covered services outpacing clinical capacity.
    • “Teladoc shares fell more than 27% on Thursday following the company’s release of its second-quarter financial performance report on Wednesday.
    • “The company is shifting from subscription to visit-based revenue models, while also transitioning its virtual mental health business to accept insurance, moving from a cash-pay model to an in-network, insurance-covered model. The company is making “considerable progress” in building the insurance offering, including establishing a baseline national footprint a year after launching its first state, Teladoc Health CEO Chuck Divita told analysts and investors on a call Wednesday. 
    • “We have contracted for over $150 million in-network lives and credentialed more than 8,000 mental health professionals for the network at this point,” he said.”
  • and
    • “Nearly three-quarters of patients with gambling disorder achieved clinically meaningful symptom improvement through Birches Health, a new study finds.
    • “The peer-reviewed outcomes study was recently published in the Journal of Medical Internet Research. It was a retrospective analysis of 1,305 adults treated by Birches between mid-2024 and mid-2026. 
    • “Birches, a virtual provider for digital addictions, says the study is the largest real-world dataset on virtual gambling disorder treatment in the U.S.” ‘
  • Beckers Hospital Review tells us,
    • “Forbes rated the country’s hospitals state by state for 2026, with 259 earning the top mark of five stars.
    • “The Forbes Top Hospitals by State list, published July 14, draws on the national Forbes Top Hospitals 2026 ratings, which score general acute-care hospitals on measures pulled from the CMS Provider Data Catalog across four areas: patient outcomes (weighted at 55%), hospital best practices (20%), value (15%) and patient experience (10%). Each hospital lands on a single Forbes Overall Hospital Quality Rating of one to five stars.
    • “The article includes] the top of that scale: every hospital awarded five stars for overall quality, grouped by state. The five-star tier spans 42 states, ranging from a single hospital in states such as Alabama, Delaware and Wyoming to 19 in Wisconsin. Eight states — Alaska, Connecticut, Hawaii, Mississippi, Nevada, New Hampshire, Rhode Island and Vermont — along with the District of Columbia had no hospital reach five stars.”
  • Radiolology Business informs us,
    • “A new analysis from Definitive Healthcare pinpoints [and the article lists] the 10 largest imaging center corporations in the U.S., based on location count. 
    • “RadNet tops the list with approximately 383 outposts at the time of the analysis, followed by the US Oncology Network (141), a chain of independent cancer docs backed by McKesson. Definitive Healthcare, a publicly traded commercial-intelligence firm, based the findings off data from its ImagingView product, which includes info from more than 22,000 centers. 
    • “As demand for outpatient imaging continues to rise, larger imaging companies are expanding through acquisitions, new site development, and care models focused on improving access and convenience for patients,” Definitive Healthcare said in an update posted July 23. “Several factors are contributing to this growth, including advances in imaging technology, increased demand for preventive diagnostic screenings, and an aging U.S. population.”
  • Fierce Healthcare notes,
    • “Health tech company Stellarus announced Thursday the launch of an artificial intelligence-driven copilot geared towards helping health plan customer service representatives.
    • ‘The solution—dubbed Customer Service Representative (CSR) Chat—provides representatives with real-time guidance and contextual support during live interactions, surfacing relevant information, policy and recommended responses directly in workflows. 
    • ‘Stellarus president and CEO Vanessa Colella told Fierce Healthcare in an interview that “unsustainable healthcare costs” have been dominating conversations about the American healthcare system.
    • “It’s not about talking about someday it might not be working,” Colella said. “It is not working today. One of the places that it’s not working is cost. And another place it’s not working is member experience.”
    • “The solution hopes to address both core issues through administrative burden reduction and allowing representatives and members “to have the conversation that matters,” according to Colella.”

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.