Friday report

Telehealth

Friday report

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

“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From Washington, DC,

  • Govexec reports,
    • “Rep. James Walkinshaw, D-Va., fresh off his reelection this week, said Thursday that he will press for a 2027 pay raise for federal workers to be part of any deal to keep the government open past December 11.
    • “The congressman, whose district is home to roughly 50,000 federal employees, told Editor-in-Chief Frank Konkel at GovExec’s After the Midterms event that the government must increase compensation in order to compete for talent, particularly after the last two years of buyouts, layoffs and mass firings. In August, President Trump formally proposed freezing most civilian federal workers’ pay next year.” * * *
    • “Walkinshaw told reporters his starting point in spending negotiations will be the 4.1% average pay increase as proposed earlier this year in his Federal Adjustment of Income Rates Act.
    • “Walkinshaw said he was also optimistic that lawmakers would pass legislation restoring the collective bargaining rights of more than 1 million federal employees, though likely not in full until after the new Congress is seated in January. The House this year has passed standalone legislation that would unwind President Trump’s executive orders, which banned unions at most federal agencies on national security grounds, and it has included language in its draft of the annual National Defense Authorization Act that would roll the edicts back for Defense Department workers.”
  • Healthcare Finance News adds,
    • “Base physician pay will decrease in 2027 under the Centers for Medicare & Medicaid Services Physician Fee Schedule Final Rule released on Wednesday.
    • “For 2026, the Working Families Tax Cut legislation provided a one-year PFS conversion factor increase of 2.5% that will no longer be in effect for 2027, CMS said. 
    • “This means that current law requires a 2.5% reduction in Medicare payment.
    • “The American Medical Association on Thursday said the lame duck session, along with the continuing-resolution bill that has funded the federal government and is set to expire on Dec. 11, creates an opportunity. 
    • “This creates an opportunity for Republicans and Democrats to unite on an end-of-year legislative package that makes real progress toward fixing the unsustainable Medicare physician payment system,” the AMA said. 
    • “Among other priorities, the AMA wants Congress to extend the 2.5% physician payment update through 2027.”
  • The Wall Street Journal relates.
    • “President Trump said on Friday that longtime adviser Stephen Miller would become his chief of staff, replacing Susie Wiles after Republicans suffered far-reaching losses in this week’s midterm election. 
    • “In a Truth Social post, Trump called Miller one of his most trusted advisers and said he would be starting in the new role on Monday. Wiles, who has served as chief of staff since the beginning of his second term, will move to the president’s political operation, Trump said.
    • “I want to thank her for her service as Chief of Staff—She has done a great job!” Trump wrote of Wiles. Wiles was the first female White House chief of staff.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced a Notice of Funding Opportunity (NOFO) for the Women’s Initiative for Screening and Health (WISH) program. The program will award up to $1 million in fiscal year 2027 to establish a multidisciplinary coalition to update the HRSA-supported Women’s Preventive Services Guidelines (Guidelines) to reflect gold-standard evidence and support their use in clinical practice.
    • “The funding opportunity advances priorities outlined in President Trump and First Lady Melania Trump’s Executive Order 14437, Advancing Women’s Health to Improve Outcomes in All Phases of Life, including translating scientific research into improved clinical care and strengthening prevention for women and girls throughout every stage of life.” * * *
    • “Applications are due January 8, 2027, at 11:59 p.m. ET through Grants.gov under opportunity number HRSA-27-072. Applicants must have active SAM.gov and Grants.gov registrations.
    • “For details and application instructions, visit the WISH funding opportunity page.”
  • Today “the Internal Revenue Service announced the tax year 2027 annual inflation adjustments for almost 70 tax provisions, including the tax rate schedules, standard deduction amounts and other tax changes. Revenue Procedure 2026-35 PDF provides details about these annual adjustments.”

From the U.S. Food and Drug Administration front,

  • Radiology Business reports,
    • “The U.S. Food and Drug Administration has cleared a new artificial intelligence-powered intravascular ultrasound imaging system, the product’s developer announced on Wednesday.
    • “San Jose, California-based Evident Vascular says the regulatory win applies to its Guidance System and Evident peripheral imaging catheters. They’re intended for examination of pathology during certain peripheral vascular procedures handled by radiologists and other docs. 
    • “Evident says the system is designed to improve the clinician experience by combining high-fidelity imaging, “purpose-built AI,” and simple workflows without disruptions. Features include flush-less plug-and-play catheters, an “intuitive” user interface, and hands-free voice controls.
    • “FDA clearance marks an important milestone for Evident and the physicians who believed in this platform from our company’s inception,” Howard Rosen, CEO and co-founder of Evident Vascular, said in a statement Nov. 4. “We engineered the entire imaging architecture to deliver the image fidelity physicians need in a system that is both intuitive and easy to use.”
  • STAT News relates,
    • “The U.S. Food and Drug Administration conducted more unannounced drug inspections in India and China in Fiscal Year 2026 compared to the previous year, Regulatory Focus tells us. The increase is attributed to an effort by the agency to increase unannounced foreign inspections to achieve inspection parity between domestic and international facilities. The proportion of unannounced inspections in India increased from 47% in FY 2025 to 87% in FY 2026. In China, the percentage of unannounced inspections rose from 19% in FY 2025 to 61% in FY 2026.”
  • BioPharma Dive tells us,
    • “Eli Lilly will offer its obesity drugs Zepbound and Foundayo on Hims & Hers’ telehealth platform, the companies announced Friday. Under the deal, eligible patients with a prescription can use Hims to gain access to Lilly’s drugs at the same “self-pay” prices available elsewhere. Foundayo carries an initial $149 monthly price tag, while Zepbound starts at $299 per month.
    • “Hims had previously used legal loopholes to make lower-cost, compounded versions of GLP-1 weight loss drugs. But it changed course in March after a legal challenge from Novo, adopting a new strategy based on providing U.S. consumers access to an array of FDA-approved weight loss medicines. Hims struck a similar deal with Novo in March.”
  • Fierce Pharma adds,
    • “Eli Lilly has successfully challenged Good Life Meds’ claims about the health benefits and personalization of a compounded tirzepatide product.  
    • “Lilly, which sells the GLP-1/GIP drug tirzepatide as Mounjaro and Zepbound, challenged the telehealth provider’s claims through BBB National Programs’ National Advertising Division (NAD). The drugmaker, the only provider of FDA-approved tirzepatide products, disputed Good Life’s claims about the effect of the compounded drug on body weight, blood sugar, energy and lean muscle. 
    • “After assessing Good Life’s response to the challenge, the NAD recommended that the company stop making the express health benefit and personalization claims challenged by Lilly and modify its ads to remove unsupported implied claims about safety, efficacy and personalization.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity.
    • “The amount of acute respiratory illness causing people to seek health care is low.
    • “RSV activity is low in most areas of the country.
    • “COVID-19 activity is declining nationally.
    • “Seasonal flu activity continues to increase in many parts of the country.
    • “Rhinovirus/Enterovirus (RV/EV) is elevated nationally, and respiratory adenovirus (HAdV) is elevated in some regions of the country.”
  • The American Hospital Association News lets us know
    • “Nationally, there are now 5,182 confirmed measles cases this year, according to a Nov. 6 update from the Centers for Disease Control and Prevention. The vaccination status of 96% cases is unvaccinated or unknown.”  
  • The New York Times tells us,
    • “A resident of Washington State died this week after a severe case of bird flu, a new and worrying sign that the virus continues to be a threat in the United States.
    • “The news followed reports that the bird flu virus had been detected in dairy cattle on dozens of farms across the country over the past month. It has also been spreading unchecked for months at a mink farm in Utah.
    • “The death, in Yakima County, Wash., is the first related to bird flu in the country this year, and the third since 2024. But it was only on Thursday, one day after an inquiry from The New York Times, that the Centers for Disease Control and Prevention updated its website. It still has not made any statements to the public about the death.” * * *
    • “Bird flu is not yet a threat to most humans, but it does pose a significant risk to the millions of agricultural workers and veterinarians in the country, said Kristen Coleman, an expert an airborne infections at the University of Maryland.”
  • Genetic Engineering and Biotechnology News adds,
    • “Researchers at the University of Cambridge and Cambridge’s spin-out DIOSynVax, along with collaborators, reported on the development of a broad-spectrum bird flu vaccine that in animal trials provided complete protection against globally circulating, diverse H5Nx variants of the disease. Current pandemic preparedness relies on stockpiling vaccines against individual virus variants that have already emerged. The Cambridge team’s approach uses AI-guided engineering to create broadly protective vaccines intended to remain effective across a wide range of existing and future variants.
    • “The team’s study, described in Cell Reports Medicine, found the new digitally engineered multi-antigen mRNA vaccine to be superior to bird flu vaccines currently stockpiled by many governments for use in the event of a human outbreak. Their preclinical trial results showed that the existing vaccines tested protected only around 50% of animals exposed to multiple H5N1 bird flu variants, compared with complete protection achieved by the team’s new vaccine, DVX-panH5Nx.
    • “The results demonstrate the potential of AI-guided vaccine design in developing broad protective population immunity ahead of evolving biological threats. The researchers say the vaccine represents the third success with their AI-guided technique for designing vaccines against highly infectious viruses that threaten animal and human health. The new study in addition demonstrates that the team’s ‘plug and play’ approach can be used to create safe, highly effective vaccines for a plethora of infectious diseases threatening animal and human health globally.”
  • Health Day informs us,
    • “A common test used to diagnose obstructive sleep apnea may miss the condition in Black patients, potentially impacting important treatment decisions.
    • “Sleep studies often use pulse oximeters — small devices that measure blood oxygen levels — to help determine the severity of sleep apnea.
    • “In the new study, oxygen-based scoring counted roughly 20 percent fewer breathing events in Black participants than in white participants.
    • “But heart-rate-based scoring showed no comparable racial difference.
    • “The first author says the findings have “potential implications for diagnosis and severity classification.”
  • and
    • “A new study suggests a woman’s reproductive history may play an important role in her brain health later in life.
    • “Women are affected by Alzheimer’s disease more often than men. This may be related, in part, to fluctuations in estrogen levels throughout life,” said study author Anna Marseglia, an assistant professor at the Karolinska Institutet in Stockholm.
    • “Estrogen is known to have protective effects on both neuronal cells and blood vessels in the brain,” she added in a news release. “However, its potential role in women’s cerebrovascular health in later life has been largely understudied.”
  • MedPage Today points out,
    • “A retrospective-cohort analysis showed that GLP-1 receptor agonists were associated with a lower risk of obesity-related cancers as compared with insulin or sulfonylurea.
    • “Cancer risk with GLP-1 agonists did not differ significantly from metformin, DPP4 inhibitors, or SGLT2 inhibitors.
    • “The effect of GLP-1 agonists on cancer risk versus other diabetes medications was most noticeable in patients with low-severity diabetes.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Humana raised its full-year earnings outlook as consolidated income and revenue rose in the third quarter.
    • “The health insurer now expects 2026 adjusted earnings of at least $9.50 a share, up from its previous forecast of at least $9 a share.
    • “Humana’s third-quarter revenue jumped 26% to $41.16 billion, beating Wall Street estimates of $40.87 billion.”
  • and
    • “Moderna raised its full-year revenue growth outlook to 15% to 25% after swinging to a profit and logging higher revenue in the recent quarter.
    • “The higher outlook follows the U.S. approval of mFLUSIVA, Moderna’s mRNA-based influenza vaccine.
    • “Moderna swung to a third-quarter profit of $162 million, beating analyst expectations for a loss.”
  • Beckers Hospital Review relates,
    • “Atlanta-based Piedmont Healthcare reported a 10.7% operating margin for fiscal year 2026, generating more than $1 billion in operating income for the second consecutive year as revenue climbed to nearly $9.5 billion.
    • “The health system recorded $1.02 billion in operating income for the fiscal year ended June 30, up slightly from $1 billion in fiscal 2025, according to its financial documents published Nov. 6. However, its operating margin narrowed from 11.4% to 10.7% as expenses increased faster than revenue.
    • “Piedmont also strengthened its liquidity position, ending the fiscal year with $3.8 billion in cash and cash equivalents, while continuing to invest in hospital expansion projects across Georgia.
  • and
    • “Grand Forks, N.D.-based Altru Health System’s operating margin fell to -3% through the first nine months of 2026, as expenses outpaced revenue growth and the system moved closer to acquiring three more North Dakota hospitals from Chicago-based CommonSpirit Health.
    • “Altru Health reported an $18.2 million operating loss for the nine months ended Sept. 30, compared with a $1.7 million operating loss and -0.3% margin during the same period in 2025, according to its financial statements published Nov. 2.
    • “Revenue increased 8.3% year over year to $610.4 million, up from $563.6 million, while operating expenses climbed 11.2% to $628.6 million, compared with $565.3 million in the prior-year period.”
  • The Wall Street Journal tells us,
    • “The practice of keeping admitted patients in the emergency room while they wait for a bed, known as boarding, is increasing in American hospitals.
    • “One in four admitted patients spent at least four hours waiting in the E.R. for a bed in September 2024, up from one in eight in September 2017.
    • “Studies show that patients stuck boarding in the E.R. face a higher risk of worse care and early clinical deterioration.”
  • Fierce Pharma informs us,
    • “Heading into Halloween weekend, both Novo and Lilly saw scripts for their oral obesity medicines tick up. 
    • “In its 30th launch week, Lilly’s Foundayo racked up roughly 65K prescriptions, seemingly topping a record of more than 64K scripts set in week 25 of the rollout, according to IQVIA data cited by Jefferies. Still, the medicine’s performance pales in comparison to Novo’s Wegovy pill at week 30 of its own launch, when the semaglutide tablet reeled in roughly 173K scripts. 
    • “For the last weekly period, the Wegovy pill charted a 0.5% script increase—or around 8K new prescriptions—to land at around 184K total. That’s roughly on par with the height of the pill’s script performance in 2026 so far and marked a rebound from roughly 183K the prior week. 
    • “Novo reported earlier this week that the Wegovy pill generated 5.39 billion Danish kroner (nearly $811 million) in third-quarter sales. Over the same period, Lilly reported $184 million in sales of Foundayo. 
    • “On an analyst call, Novo’s EVP of U.S. operations, Jamey Millar, resurfaced caveats with the data IQVIA is using to track the oral GLP-1 launches, arguing that Novo boasts “a much more extensive ecosystem of partners for Wegovy” than Lilly, and that those partners “don’t report to IQVIA in absolute terms.” 
    • “So we’ve consistently seen a lower capture rate for Wegovy pill than the competitive oral product,” he suggested. 
    • “Based on the latest weekly metrics, Lilly holds a little more than a 26% share of the overall oral obesity market compared to Novo’s nearly 74%, the Jefferies team said in its note.” 

Midweek report

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

“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From the national election front,

  • The Wall Street Journal reports.
    • “Vice President JD Vance blamed the Iran war for Republicans’ heavy midterm losses, saying “everyone knows why we lost.” The comments came a day after Democrats took control of the Senate and House in a blue wave that surged across the country, extending into traditionally red states in a repudiation of President Trump.
      • House: As more races are called, Democrats are expanding the majority they clinched in the chamber last night. [As of this writing, the Democrats have 237 seats and the Republicans 147.] Meanwhile, with House Speaker Mike Johnson saying he wouldn’t run for minority leader, House Republicans are already jockeying for the job.
      • Senate: Democrats have flipped seven seats so far in the Senate. [As of this writing the Democrats have 54 seats and the Republicans 44.] Two races have yet to be called in which the Democratic candidate currently has a slight edge over the Republican incumbent: Alaska and Mississippi. It’s unclear when those results will be announced.
      • Trump: The president appeared at the site where his ballroom is being constructed and took a few questions from reporters. Among other things he said Vance’s assessment of the impact that the war with Iran had on the midterms was “largely true” and that he wasn’t considering replacingDefense Secretary Pete Hegseth.
  • Beckers Hospital Review tells us,
    • “Health insurer and hospital stocks climbed Nov. 4 after Democrats won majorities in both chambers of Congress in the Nov. 3 midterm elections, as analysts said the new Congress could delay Medicaid cuts and restore enhanced ACA subsidies.”
  • Fierce Healthcare lets us know in more depth “what Democratic control of Congress means for healthcare in 2027.”
  • Beckers ASC Review points out “Physicians who won in the 2026 midterms.”

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

  • Govexec reports,
    • “Following the drubbing of congressional Republicans in Tuesday’s midterm election, federal employee unions are hopeful that the change in control on Capitol Hill will precipitate action to roll back some of the Trump administration’s efforts to reshape the federal workforce.”
  • Fedweek tells us,
    • “The annual federal benefits open season starting next Monday (November 9) and running through December 14 provides an opportunity for current enrollees change FEHB/PSHB health insurance plans’ change levels of coverage, for plans that have more than one; and change among self-only, family and self plus one options.” * * *
    • “Even enrollees happy with their same coverage should look at the offerings, experts advise, since benefits do change somewhat year to year. And within the average premium increase there is variation, with some plan premiums increasing by well more than the average.
    • “A summary of general changes to coverage terms in both programs is here; check a plan’s brochure for its specifics. OPM’s main open season resources page is here.
    • “Tables of plans leaving the programs or reducing service areas are here for FEHB and here for PSHB. Affected enrollees in these plans who don’t choose a new one will be moved to Compass Rose Standard if in FEHB and in FEP Blue Focus if in PSHB.”
  • and
    • “While most of the attention focuses on the FEHB health insurance program during the annual benefits open season—this year November 9-December 14—the open season also provides federal employees and retirees the opportunity to elect or change vision and/or dental coverage in the FEDVIP program, and for employees to begin or renew flexible spending accounts for the new year.” * * *
    • “Those who wish to have a dependent care and/or health care flexible spending account must make a new election during the open season. The IRS has not yet announced the maximums in those programs for 2027; for 2026, they were $7,500 individually or for a couple filing federal income taxes jointly ($3,750 for married individuals filing separately) for dependent care accounts and $3,400 (individually) for health care accounts.” * * *
    • “The open season does not apply to the other two federal insurance programs, the FEGLI life insurance program and the FLTCIP long-term care insurance program. FEGLI conducts open seasons only rarely, although new enrollments or coverage changes are allowed in certain circumstances at other times. The FLTCIP has not accepted new applications for enrollment or changes in existing enrollment since 2022; there has been no indication of that suspension being lifted.”
  • FedSmith discusses “Preparing for Medicare: FEHB Decisions at Age 65
    • “Learn how Medicare and FEHB work together at 65. Understand Medicare Part A, Part B, and make smart retirement healthcare decisions early.”

From the Medicare front,

  • Beckers Hospital Review notes,
    • “On Jan. 1, 2027, Medicare’s negotiated prices for 15 more drugs take effect, including the semaglutide products Ozempic, Wegovy and Rybelsus. They join the 10 drugs whose first-round negotiated pricestook effect this year. For hospital pharmacies, the date matters twice: several of the same drugs also move to rebate-only 340B pricing that day if the program takes effect as scheduled.”

From the U.S. Food and Drug Administration front,

  • STAT News reports,
    • “Democrats’ landslide victory in the midterm elections may have significant implications for the upcoming negotiations over a key funding source for the Food and Drug Administration, in part by empowering a major critic of the program.
    • “The FDA collects user fees from pharmaceutical companies to fund the agency’s reviews of their medicines. The Prescription User Fee Drug Act must be renewed before the current law expires on Sept. 30. Otherwise, it could disrupt the FDA’s ability to approve medicines.
    • “The power to shape that legislation will fall to senior Democrats, including Sen. Bernie Sanders (I-Vt.), who will likely lead the Senate’s health committee. Sanders is one of the few lawmakers who have opposed the core premise of the user fee structure.
    • “Now, he will have a chance to fundamentally alter how the FDA interacts with the companies it regulates.” 
  • Cardiovascular Business relates,
  • Contemporary OB/GYN shares professional “reactions to FDA’s boxed warning removals for menopausal hormone therapy.”

No Surprises Act News

  • The New York Times reports,
    • “The federal government plans to end contracts with two arbitration firms that settle medical billing disputes under the No Surprises Act, a consumer protection law that has come under scrutiny for high payouts for doctors.” * * *
    • “The arbitrators’ contracts last five years, and the government is now reviewing those awarded in 2022.
    • “Two firms, Island Peer Review Organization and Network Medical Review Company, were notified on Wednesday that the government does not plan to renew their contracts, according to a notice published that day.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Lung cancer remains the leading cause of cancer death in the U.S. and sits at the intersection of several pressures health systems are already managing: an aging patient population, uneven access to screening and a disease that is still most often caught too late. 
    • “How lung cancer affects a health system depends heavily on where it operates. Incidence, mortality, screening and smoking rates, along with Medicare spending, vary widely from state to state.
    • “For healthcare leaders, those state-level differences can inform decisions about screening programs, patient volume and investment in early detection.
    • “Becker’s compiled a list of the facts and figures healthcare leaders need to know about lung cancer using data from the American Cancer Society, the CDC, CMS and a lung cancer screening study published Dec. 9, 2025, in CHEST.”
  • and
    • “Hawaii and Louisiana continue to report the highest percent of influenza-like illnesses as the U.S. experiences an earlier-than-usual flu season.
    • “The CDC defines influenza-like illness, or ILI, as a fever of 100 degrees or greater, along with a cough and/or sore throat. The agency collects data on outpatient visits to healthcare providers for respiratory illness through ILINet. ILI percentages are weighted for state population and compared to baseline levels to assess flu activity. For more information on how the metric is calculated, click here.
    • “Hospitals reported 6,100 new flu admissions in the week ending Oct. 24, up from 4,811 the week prior, according to the CDC’s latest FluView report. This accounts for a 27% week-over-week increasein flu admissions. 
    • “About 2.4% of outpatient visits involved patients with respiratory illness. This metric sits below the national baseline of 2.9% and is up from 2.2% the week prior.”
  • The Washington Post relates,
    • “Peanuts, and peanut butter in particular, are some of the most ubiquitous elements of a child’s diet, and so when a kid is allergic to them, it can be a unique vexation for parents. It means no PB&Js for lunch — but also an endless list of logistics, from having to check in with the parents any time their kid goes over to a friend’s house to communicating with school officials.
    • “It turns out that for many kids thought to have peanut allergies, much of that vigilance may not be necessary. 
    • “A new peer-reviewed study, published Nov. 4 in the Journal of Allergy and Clinical Immunology: In Practice, suggests that fewer young children than previously thought have long-lasting peanut allergies. The findings could change how we make early-childhood allergy diagnoses and how to think about treating allergies moving forward.”
    • “Tim Brettig, a pediatric allergist and immunologist, and a senior research clinician at the Murdoch Children’s Research Institute in Melbourne, Australia. said that means many parents who think their children have lifelong allergies to peanut butter might want to reexamine the matter carefully. “If you’ve had a clear reaction, I would be less inclined to accept a peanut allergy diagnosis,” said Brettig, one of the lead researchers on the new study. “I’d want to continue that work-up. I think food challenges should play a greater role in the allergy assessment of children. Give them a chance to prove that they’re not allergic.” 
    • “The key is a controlled environment, such as a doctor’s office, for checking again, Brettig said. About 12 percent of the babies given the oral food challenge did experience anaphylaxis, the whole-body and sometimes life-threatening reaction that is the most severe response to an allergen. But because they were in an environment with medical professionals to administer care, no long-term harm came to any of the children. “It’s not necessarily something that I’d be doing in a community setting,” said Brettig. “You’d want it to be done with specialists that are skilled in performing these food challenges.”
  • The New York Times adds,
    • “Kratom, long used by people seeking relief from addiction to prescription opioids and alcohol, is increasingly being pitched as a wellness product that purports to raise energy, sharpen focus and enhance athletic performance.
    • “Some makers of kratom, a substance that is derived from the leaves of a tropical tree and often sold in the form of drinks, powder or capsules, have distributed free samples at gyms. Others have sponsored sporting events or trumpeted the product’s benefits with the help of social media influencers and wellness podcasts.
    • “What this marketing often fails to acknowledge is the potential for kratom to lead to addiction, liver injury, seizures and in some cases, fatal overdoses.”
  • Healio tells us,
    • “Individuals with inflammatory bowel disease who have at least two first-degree relatives with colorectal cancer appear to have the greatest increase in risk for CRC, according to results of a Swedish cohort study.
    • “Analysis also showed that having a relative with early-onset CRC was associated with a more modest risk, a finding that diverges from prior research.”
  • Health Day informs us,
    • “Gestational weight gain (GWG) outside of recommended ranges is associated with increased severe maternal morbidity (SMM) risk, according to a study published online Oct. 22 in JAMA Network Open.
    • “Sahar Khademioore, from McMaster University Medical Center in Hamilton, Ontario, Canada, and colleagues examined the association between GWG and SMM across prepregnancy body mass index (BMI) categories.”
  • Per an NIH news release,
    • “Results from a clinical trial funded by the National Institutes of Health (NIH) in five major United States cities show that delivering integrated HIV and substance use disorder (SUD) services using peer navigation in mobile medical units reduced all-cause deaths by 71% compared to participants who received peer navigation to community-based services alone. While scientists found no difference in the use of daily, oral preexposure prophylaxis (PrEP) and medication for opioid use disorder (MOUD) between the groups, the secondary outcome of reduced mortality was significant. 
    • “Injection drug use is an important contributor to HIV in the U. S. that also increases risk for other serious infectious diseases,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA), which funded the study. “Although we have effective interventions for this population, there are significant barriers to their accessibility and use. Nonetheless, these findings suggest that delivering low threshold services through mobile units could save lives.” 
  • Beckers Behavioral Health adds,
    • “Researchers at St. Louis-based Washington University School of Medicine found that among patients presenting to the emergency department with a substance-related problem, cannabis was most common among adolescents while alcohol was most common among older adults. 
    • “The study, published Nov. 4 in The American Journal of Psychiatry, analyzed data from large health insurance databases for more than 1.3 million patients ages 16 to 64 who had at least one substance-related emergency care visit between January 2016 and December 2023. Researchers analyzed the data by age group and substance used.” 
  • BioPharma Dive points out,
    • “Sanofi has stopped development of an experimental protein-degrading immune disease drug licensed from biotechnology company Nurix.
    • “Nurix on Tuesday revealed Sanofi’s decision to scrap “SAR448272,” an oral medicine designed to eliminate STAT6, a protein involved in many inflammatory conditions. Nurix didn’t specify the reason for the decision, but Sanofi separately told analyst firm Leerink Partners “emerging nonclinical findings … didn’t warrant further development” in eczema, according to a note to investors. 
    • “Nurix received a $10 million payment from Sanofi in August when a Phase 1 study began and would’ve been eligible for additional payouts if the treatment moved forward in testing.”
  • and

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

  • The Wall Street Journal reports,
    • “CVS Health raised its full-year guidance on gains in its health-care benefits and pharmacy segments, but said it remains cautious amid high costs and potential macroeconomic headwinds.
    • “The outlook comes after the company said Tuesday that it plans to split in two, with one company housing its insurance giant Aetna and pharmacy-benefit manager Caremark, and the other its 9,000 retail pharmacies.
    • “CVS said the breakup, slated for early 2028, will enable the two separate management teams to focus more on their respective businesses and be more agile, The Wall Street Journal reported.
    • “For the current fiscal year, the company on Wednesday said it now expects adjusted earnings of at least $8.20 a share, up from its previous forecast of between $7.90 and $8.10 a share. Analysts polled by FactSet anticipate adjusted earnings of $8.05 a share.
    • “CVS also said it now projects revenue of at least $420 billion for the year, compared with its previous forecast of at least $414 billion. Wall Street is modeling for revenue of $417.7 billion.
    • “Each of our businesses delivered another quarter of strong results,” Chief Executive David Joyner said. “We continue to advance our strategy by improving the consumer experience, lowering health care costs, and connecting care for the people we serve.”
  • and
    • “Novo Nordisk raised its annual guidance due to an improved outlook for its key obesity and diabetes drugs.
    • “The Danish drugmaker now expects adjusted sales and operating profit to range from a 2% decline to 2% growth at constant exchange rates.
    • “Third-quarter sales of the Wegovy pill reached the equivalent of $807.2 million, beating analyst expectations of 4.5 billion kroner.”
  • and
    • “AstraZeneca recently made a roughly $10 billion offer to buy Rhythm Pharmaceuticals RYTM 28.04%increase; up pointing triangle, according to people familiar with the matter, a deal that would expand its portfolio of rare disease treatments. 
    • “The U.K. pharmaceutical giant offered to pay $124 a share for the biotech last month, the people said. 
    • “Rhythm specializes in treatments for metabolic conditions and severe obesity. Its shares were trading Wednesday afternoon at around $95 apiece before The Wall Street Journal reported on the offer. They closed up 28% at over $110 a share following the report, giving the company a market value of roughly $7.6 billion. AstraZeneca had a market value of close to $300 billion.”
  • Beckers Hospital Review lets us know how “Health system CEOs close margin gaps with operational redesign.”
  • Fierce Healthcare informs us,
    • “As health plans and employers contend with a growing array of virtual care and AI-enabled tools, Amwell is positioning its digital health platform as the infrastructure layer for AI-enabled care.
    • “Executives at Amwell, formerly known as American Well, touted the company’s platform strategy, government contracts and higher-value clinical services as the main drivers of future growth during the company’s third-quarter earnings call Tuesday.
    • “Rising healthcare costs are pushing health plans and employers to adopt tech-enabled care solutions, but they are looking for measurable engagement and outcomes from digital health vendors, not just access, according to Ido Schoenberg, M.D., Amwell chairman and CEO.
    • “The proliferation of point solutions, accelerated by AI, is creating more vendor sprawl and member confusion, Schoenberg told investors and analysts during the call.” * * *
    • “This is the problem Amwell is determined to solve for our customers. We help them improve clinical and financial outcomes. We do it through activation, getting more of their members into technology-enabled care in place of conventional care that often costs more. We give our customers one platform under their brand with one integration. It provides reliable, scalable rails to bring in a program, exchange data with it, and tests whether it works. The member’s experience stays consistent, simple, and engaging. A common data structure proves the outcomes and improves performance over time,” he said.
    • “As AI adoption grows, a unified care platform becomes more valuable, Schoenberg asserted.”

Midweek report

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

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • “The Trump administration is delaying by 90 days a federal rule that could prevent Americans from obtaining prescription drugs from licensed international pharmacies.
    • “The move follows growing criticism that the rule, which was initially slated to go into effect on Oct. 22, could drastically reduce the flow of medicines from Canada and other countries. In recent weeks, patient advocacy groups and dozens of congressional lawmakers urged the administration to rethink its approach.” * * *
    • “This gives the FDA time to work with CBP to ensure a pathway for patients to continue importing more affordable prescription drugs for personal use when the rule is implement, based on identifiable safety criteria,” said Gabriel Levitt, who heads Prescription Justice, an advocacy group. “That’s what members of Congress have called for and that’s what the law says FDA should do.”
  • Per Department of Health and Human Services news releases,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. yesterday determined that public health emergencies exist in Florida and Alabama as a result of Hurricane Isaias. The determinations follow President Trump’s October 9 emergency declarations for both states (Florida, Alabama).
    • “The President’s declarations and the Secretary’s determination allow HHS to authorize temporary waivers and modifications of certain requirements. These flexibilities help the Centers for Medicare & Medicaid Services (CMS) support healthcare providers and suppliers serving people enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) in the covered emergency areas.” * * *
    • “Prior to landfall, ASPR pre-positioned regional staff in areas at risk from the storm to monitor the impacts on public health and healthcare systems and provide technical assistance in anticipation of state requests. Healthcare System Assessment Teams also deployed to evaluate the storm’s impact on healthcare facilities.
    • “In addition, ASPR shared HHS emPOWER datasets with states in the storm’s path. These data can help responders identify, by geographic area, the number of Medicare beneficiaries relying on electricity-dependent medical equipment or certain essential healthcare services, including facility-based dialysis and home healthcare.”
    • In declaring the public health emergency and authorizing flexibilities for CMS providers, suppliers, and beneficiaries, Secretary Kennedy acted within his authority under the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to October 6, 2026, in the state of Florida and October 7, 2026, in the state of Alabama.
  • and
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., joined by Health Resources and Services Administration (HRSA) Administrator Tom Engels, today launched the HHS Health Center Healthy Lifestyle Commitment, a voluntary initiative that encourages health centers nationwide to put nutrition, prevention, and healthy living at the center of patient care.
    • “Secretary Kennedy announced the initiative during a visit to Piedmont Access to Health Services (PATHS) health center in Chatham, Virginia, where he highlighted the role health centers play in preventing chronic disease and helping patients build healthier lives.”
  • PBS News tells us,
    • “Social Security checks will increase by roughly $76 per month for the average retired worker in 2027, the federal government announced Wednesday.
    • “The payment jump is due to the Social Security Administration’s annual COLA, or cost-of-living adjustment, which has been determined each fall for decades. Next year’s increase is 3.6%, based on inflation data, amounting to a little more than $900 next year.”
  • Govexec adds,
    • Because “[t]he Social Security Administration announced Wednesday that Social Security beneficiaries will receive a 3.6% cost-of-living adjustment next year, Federal retirees in the Civil Service Retirement System will therefore receive a 3.6% increase to their annuities next year, but former feds who are part of the Federal Employees Retirement System, launched in the 1980s alongside 401(k)-style Thrift Savings Plan, will see only a 2.6% adjustment.
    • “That’s because FERS’ annual cost-of-living adjustment is based on an extrapolation of the CSRS and Social Security increase. Each year, if CSRS sees an increase of less than 2%, FERS retirees receives the full COLA. But if the figure falls between 2% and 3%, FERS participants receive only a 2% increase, while if the COLA is 3% or more, like this year, FERS enrollees receive that adjustment, minus 1 percentage point.”

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

  • OPM posted in the Federal Register a direct final rule amending OPM’s Family and Medical Leave Act (FMLA) regulations in subpart L of part 630 of title 5, Code of Federal Regulations (CFR) to reflect statutory changes enacted in January 2021 and December 2023.
  • Per a U.S. Office of Personnel Management news release.
    • “U.S. Office of Personnel Management (OPM) Director Scott Kupor, Vice Chair of the Super Intelligence Task Force, joined Kayleigh McEnany on Fox News’ Saturday in America to discuss the task force’s work, the importance of U.S. leadership in SI, and the responsibility of technology companies to develop and release safe products.”
  • Govexec reports,
    • “The federal government’s human resources agency is revamping one of the most heavily trafficked tools on its website: annual pay tables for federal employees. 
    • “The Office of Personnel Management is planning to launch a new version of the online tables that agencies and employees use to look up federal pay rates each year.
    • “Adam Starr, the agency’s chief information officer, said on Wednesday that the agency’s pay rates website gets about 14 million visits each year, but hasn’t changed much since 2011. 
    • “I always like to remember that ‘OPM’ really stands for ‘other peoples’ money.’ And in this case, it is your money. People come to OPM pay tables, asking us to show them the money, and for years these have been legacy, clunky sites,” Starr said Wednesday at the SAP Public Sector Summit sponsored by GovExec. “It’s not the experience that a federal employee deserves.” 
    • “Starr said the revamped OPM pay tables will launch “later this calendar year,” in the first quarter of fiscal 2027.” 
  • A FedWeek article provides “a detailed explanation by OPM of changes in coverage terms for the 2027 plan year in the FEHB and PSHB programs, ahead of the open season that will run November 9 – December 14 (brochures with specifics by plan are to be released in early November).
    • FEHBlog observation: Historically the FEHB and PSHB plan carriers have posted their brochure on their websites before OPM does in early November.

From the U.S. Food and Drug Administration front,

  • Fox Business reports,
    • “More than 112,000 bottles of Amazon-branded extra-strength acetaminophen are being recalled after consumers reported discolored pills, according to the Food and Drug Administration (FDA).
    • “Aurobindo Pharma USA, a New Jersey-based pharmaceutical company, initiated the voluntary recall on Sept. 18, affecting three bottle sizes of Amazon Extra Strength Acetaminophen 500 mg caplets.
    • “The recall remains ongoing, according to the FDA.”
  • Cardiovascular Business adds,
    • “This voluntary recall includes 22 different lots of Argatroban Injection, a direct thrombin inhibitor used for prophylaxis or to treat blood clots in adult patients with heparin-induced thrombocytopenia (HIT). It can also work as an anticoagulant in adult patients with or at risk of HIT who are undergoing percutaneous coronary intervention (PCI) procedures. 
    • “According to new details shared by the U.S. Food and Drug Administration (FDA), the particulate matter in question has been identified as cellulose, polystyrene, polyethylene, terephthalate and stopper material. Some of it may also be stainless steel. The Argatroban Injection being recalled is delivered to a patient intravenously. If patients were treated with the contaminated drug, they would face a risk “life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels and/or inflammation of the wall of veins, which may lead to clotting.
    • “Par Health did emphasize that there have been no reports of adverse events related to this issue. 
    • “The drugs included in this recall were distributed by Par Pharmaceutical or Endo USA from December to May 2026. The lots are all set to expire as early as October 2026 and as late as September 2027.” 
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), given with Bacillus Calmette-Guérin (BCG), to include adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and has not responded to BCG treatment. Anktiva is the first FDA-approved treatment specifically for patients with BCG-unresponsive, high-grade papillary-only disease. 
    • “The approval marks a new FDA approach to evaluating treatments for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The agency based its decision on evidence supporting an earlier approval of Anktiva for adults with another form of NMIBC, carcinoma in situ (CIS), with or without papillary tumors, and scientific similarities between CIS and high-grade papillary-only disease.
    • “We listen to patients, clinicians, and researchers, and we act when the science supports a new approach,” said R. Angelo de Claro, M.D., Director of the FDA’s Oncology Center of Excellence. “For Anktiva, our review of the similarities between these cancers allowed us to build on the results in patients with CIS and expand treatment options for people with high-grade papillary tumors alone. This approach may also help guide the development of future treatments.”
  • Beckers Behavioral Health points out,
    • “The FDA has taken a string of actions in recent months that could reshape how substance use disorders, ADHD and other behavioral health conditions are treated in the years ahead. 
    • “From clearing a novel alcohol use disorder drug for trials to approaching the first new ADHD medication class in decades and backing psychedelic research under a White House directive, the agency’s recent moves point to accelerating momentum in behavioral health drug development.” 
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases. As outlined in a new white paper, the Initiative will develop an optimized, fit-for-purpose framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type and the evidence that can be realistically generated in small patient populations.
    • “To solicit feedback on the Rare Disease Framework Initiative from patients and disease advocates, industry, and others, the FDA will host an October 28 meeting at the FDA’s White Oak campus. The meeting will be facilitated by the Reagan-Udall Foundation for the FDA.”

No Surprises Act News

  • CMS announced
    • “Beginning November 13, 2026, organizations with IDR Gateway accounts can submit “Notice of IDR Initiation,” “Notice of IDR Initiation Response,” “Notice of Certified IDR Entity Selection,” and “Notice of Offer” web forms in the Independent Dispute Resolution (IDR) Gateway.
    • “IDR Gateway users can also view reports and access dispute records for disputes started within the IDR Gateway, as well as disputes started outside the IDR Gateway that were successfully mapped to an organization using the dispute mapping process.”

From the Medicare Advantage front,

  • The New York Times discusses CMS’s upgraded Medicare Plan Finder website.
    • “For the first time, beneficiaries and those who help them can type in the name of any licensed health care provider — not just doctors, which was the case last year — and find which Advantage plans they accept.”

From the Affordable Care Act marketplace front,

  • Modern Healthcare reports,
    • “A new draft regulation would tighten access to health insurance exchange subsidies as federal agencies continue implementing President Donald Trump’s tax law.
    • “The IRS issued a proposed rule Wednesday that would set stricter definitions of who qualifies for tax credit subsidies, toughen eligibility verification requirements and narrow access to financial assistance for noncitizens.
    • “This regulation would complement pending rules from the Health and Human Services Department and the Centers for Medicare and Medicaid Services.
    • “The IRS and the Treasury Department characterized the policies as part of broader Trump administration efforts to reduce fraudulent activity on the exchanges, such as removing enrollees from the rolls and freezing broker enrollment.
    • “The proposed rules protect eligible taxpayers while strengthening the integrity of the premium tax credit,” IRS CEO Frank Bisignano said in a news release. “The enhanced verification measures are designed to curb improper claims, ensuring these vital tax benefits go strictly to the hardworking Americans who qualify for them.”
  • Per an HHS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) continue to crush fraud, waste, and abuse in America’s healthcare programs by stopping duplicative enrollment in government health programs, with the potential to save taxpayers approximately $1.5 billion over the next year.
    • “In 2026, CMS identified 189,000 people who had subsidized Obamacare coverage through the Federal Marketplace and either had duplicate Medicare, Medicaid or Children’s Health Insurance Program (CHIP) coverage or were deceased. CMS took swift action to remove Obamacare subsidies for these people to save taxpayer dollars.”

From the public health and medical / Rx research front,

  • Reuters reports,
    • “The US CDC said on Tuesday it would deploy additional support to Pennsylvania to help investigate the ongoing measles ​outbreak, as the state formally requested federal assistance through the ‌agency’s Epi-Aid emergency response program.” * * *
    • “The agency said it would work with local health officials to investigate the outbreak, strengthen response efforts and prevent spread.
    • “Texas, South Carolina, Virginia, Kansas, New ​Mexico, and Wisconsin requested CDC Epi-Aids and worked alongside federal teams to ​help bring their outbreaks rapidly and successfully under control,” the agency said in a ‌statement.”
  • The New York Times relates,
    • “Pope Leo XIV had a “good” second night in the hospital after surgery to remove a cancerous nodule on his lung, the Vatican said on Thursday.
    • “The pope had a good night in the hospital. He got up and had breakfast,” the Vatican said on Thursday morning.
    • “Leo’s lung cancer diagnosis has cast uncertainty over his agenda and raises questions about succession about a year and a half into his papacy.
    • “The Vatican said that doctors operating on the pope in Rome on Tuesday confirmed he has ​lung adenocarcinoma, a common form of lung cancer that can be highly treatable when caught early. Surgeons removed the lower lobe of his right lung.”
  • Healio tells us,
    • “In 2023, the age-standardized mortality rate for asthma was lower than that of 1990 by 50.94%, whereas the 2023 rate for COPD was higher than the 1990 rate by 8.9%, according to data published in The Lancet Respiratory Medicine.” * * *
    • Between 1990 and 2023, the estimated number of people living with chronic respiratory disease in the U.S. rose from 33.28 million to 54.5 million.
    • “Increases between these years were also observed in the age-standardized prevalence rate (+10.24%) and the age-standardized mortality rate (31.19 per 100,000 population to 34.56 per 100,000 population). According to researchers, the modest increase in the mortality rate signals “persistent gaps in disease control.”
    • “When broken down by disease type, the study found that the age-standardized mortality rate in 2023 was higher than that of 1990 for COPD (+8.9%) and ILD and pulmonary sarcoidosis (+87.47%), whereas the 2023 rate was lower than the 1990 rate for asthma (–50.94%) and pneumoconiosis (–75.19%).” * * *
    • “Integrating tobacco control measures, equitable vaccination programs and targeted health-system investments could help to address the uneven burden of chronic respiratory diseases across U.S. states and the growing mortality gap despite stable prevalence, although further research is needed to clarify which specific policy determinants underlie these associations,” Yon and colleagues wrote.”
  • and
    • “Women with polycystic ovary syndrome, now known as polyendocrine metabolic ovarian syndrome, may have elevated risk for Alzheimer’s disease and related dementias, a review article stated.
    • “However, the higher risk may be mediated by metabolic disorders, the researchers wrote. 
    • “In findings published in the Journal of the Endocrine Society, researchers identified multiple studies that reported people with PCOS/PMOS have increased risk for Alzheimer’s disease and dementia. However, there remain several unanswered questions, including whether PCOS/PMOS independently raises Alzheimer’s disease risk and if any interventions may reduce the elevated risk in the PCOS/PMOS population. 
    • “The data indicate that it is critical to further assess the possible link between PMOS, metabolic dysfunction and Alzheimer’s disease, but we should recognize that according to the information we reviewed, this link is still hypothetical and much more research is needed,” Ricardo Azziz, MD, MPH, MBA, executive director at the Foundation for Research & Education Excellence and professor in the School of Medicine and School of Public Health at University of Alabama at Birmingham, told Healio.”
  • Radiology Business tells us,
    • “Researchers have developed a way of adapting adult radiology artificial intelligence models for the pediatric population. 
    • “Currently, only about 17% of U.S. Food and Drug Administration-authorized AI medical devices are labeled for use with children. That’s because most models are trained on adult data and do not translate well for infants and kids, experts write Tuesday in Nature Biomedical Engineering. 
    • “One key impediment is that medical records in pediatrics are subject to strict privacy regulations, with data tending to remain at the institution where treatment occurred. Currently, kids represent less than 1% of public medical imaging datasets. 
    • “Because it’s so much harder to get data for children, this transformative technology is disproportionately being developed to help adults,” lead author Vishwanatha Rao, a MD-PhD student with the University of Pennsylvania and research fellow at Harvard, said in a statement Oct. 13. “Children are being left behind.”
    • “To address this, Rao and colleagues championed a way of adapting one model, trained on adult X-rays, for the pediatric population. Their approach used data from multiple hospitals without sensitive information ever leaving each institution. “The model travels, but the data stays in-house,” experts noted.” 
  • Genetic Engineering and Biotechnology News notes,
    • “Researchers at Baylor College of Medicine, the Duncan Neurological Research Institute (Duncan NRI) at Texas Children’s Hospital, and collaborating institutions have identified new genetic candidates that help explain why autism is diagnosed about four times more often in boys than it is in girls. The study, involving tests in induced pluripotent stem cell (iPSC)-derived neurons (iNeurons), revealed that small changes in the gene MECP2 on the X chromosome might help explain part of this difference.
    • “Huda Zoghbi, MD, Distinguished Service Professor at Baylor, director of Duncan NRI, and a Howard Hughes Medical Institute investigator, is senior and corresponding author of the team’s published paper in The American Journal of Human Genetics, titled “A massively parallel reporter assay of MECP2 cis-regulatory elements reveals genetic candidates for male-biased autism.” In their paper, the team concluded, “These findings suggest noncoding MECP2variants can cause idiopathic, male-biased autism and provide a framework for uncovering regulatory variants in other X chromosome neurodevelopmental genes that may contribute to autism’s missing heritability.”
  • MedPage Today informs us,
    • “There are no licensed vaccines targeting invasive E. coli disease, an acute illness that can lead to sepsis and death.
    • “In a phase III trial of older adults, the nine-valent ExPEC9V vaccine’s efficacy rate of 14.6% indicated no protective effect against invasive E. coli disease.
    • “The results led to an early termination of the trial, and development of the vaccine has been discontinued.”
  • Per Bio-Pharma Dive,
    • “An experimental RNA interference drug developed by Arrowhead Pharmaceuticals lowered levels of an Alzheimer’s-linked protein in an early trial in healthy volunteers, signaling the medicine might be helpful in treating the memory-robbing condition.
    • “Arrowhead said the highest dose of its drug, administered in two injections spaced two weeks apart, dropped levels of that protein, “tau,” by an average of 73% after 105 days. The findings suggest the medicine, called ARO-MAPT, could be injected once every three months.
    • “The news comes as developers of RNA-modulating medicines have been increasingly exploring ways to overcome a longstanding research limitation by aiming their treatments at targets outside the liver. Arrowhead said the results from this early-stage trial “provide clinical validation” of a development platform that enables its drugs to reach cells elsewhere, including those in the central nervous system protected by the “blood-brain barrier.”
  • and
    • “Verastem Oncology shares rose 18% Wednesday after the company released highly anticipated early data suggesting its experimental cancer drug could help certain patients with three different types of tumors.
    • “The drug, VS-7375, targets the most prevalent of the “KRAS” mutations that drive cancer, one known as G12D. The medicine is designed to bind to both the “on” and “off” states of the mutation, which may allow it to hold back tumor growth more completely than rival treatments that only target one or the other, Verastem said.
    • “The small study included patients with metastatic pancreatic ductal adenocarcinoma, metastatic colorectal cancer and advanced non-small cell lung cancer. Based on the results, the company plans to kick off a trio of late-stage trials before the end of June.”

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

  • Human Resource Director reports,
    • “Employer health costs are on track to rise 8.2 percent per employee in 2027, the steepest increase since 2003, and many employers say they cannot get the claims data needed to explain why.
    • “Marsh, the benefits consultancy formerly known as Mercer, reached that figure in its 2026 National Survey of Employer-Sponsored Health Plans, which collected responses from more than 1,800 US employers between June 10 and August 10, 2026. Employers said costs would climb 11 percent if they took no action, and 59 percent plan cost-cutting changes such as higher deductibles. A separate Marsh survey found that about two-thirds of employers with 500 or more workers expect to raise employees’ share of premiums, so many workers will see paycheck deductions rise by more than the average. Aon and Business Group on Health have published similar pre-mitigation forecasts of 9.5 percent and 9.2 percent for 2027.
    • “Our report on Marsh’s 2027 health benefit cost projections covers the three newer drivers. Marsh’s actuaries attribute roughly one percentage point each to glucagon-like peptide-1 (GLP-1) weight loss drugs, artificial intelligence (AI)-enabled claims submission software and disputes under the No Surprises Act’s Independent Dispute Resolution (IDR) process.”
  • Beckers Hospital Review relates,
    • “Chicago-based Rush University System for Health and Evanston, Ill.-based Endeavor Health announced plans to merge Oct. 14. The transaction is expected to close in early 2027.
    • “Endeavor plans to fund a $1 billion investment as part of the deal, including $300 million to broaden community impact, $500 million for academics and research, and $200 million for quality care and innovation, according to a joint press release. The investment will also fund community partnerships focused supporting social determinants of health and underserved members of the community.
    • “Together, Rush and Endeavor Health have an opportunity to create a stronger, more connected health system that sets a new standard for how care is delivered and experienced across our communities,” said Gerald “J.P.” Gallagher, president and CEO of Endeavor. “Patients and communities will benefit from improved access, advanced research and nationally recognized, high-quality care close to home.”
    • “When the deal is finalized, the system will operate under the Rush brand based on the brand’s “strong national reputation and position as a leading academic institution,” according to the press release, with a commitment to academics, care quality and innovation.”
  • and
    • “Greensboro, N.C.-based Cone Health is sunsetting its Hospital at Home program, according to an Oct. 14 statement from the health system shared with Becker’s. 
    • “Cone Health made the decision following a comprehensive review of its priorities and the model’s sustainability. 
    • “The statement noted that health systems across the U.S. continue to evaluate hospital-at-home programs as they navigate evolving reimbursement models, operational complexity and long-term sustainability. 
    • “The program, which launched in April 2025, reported strong first-year results on June 1, including no patient deaths or healthcare-acquired infections. Cone Health had limited the program to six patients at a time and had planned to expand it once more payers covered the model.” 
  • Healthcare Dive adds,
    • “Nonprofit health systems MultiCare and Samaritan Health Services will merge on Nov. 1 after gaining approval from state regulators, the companies announced Monday.
    • “As part of the deal, MultiCare – which operates 13 hospitals –  will begin an affiliation with Samaritan and its network of five hospitals. MultiCare, which is based in Tacoma, Washington, will also invest $700 million over 10 years into Oregon-based Samaritan. Samaritan will continue to use its name, alongside MultiCare’s branding, the health system said.
    • “This milestone brings us closer to putting the investment and resources of our partnership to work for the people we serve.” said Marty Cahill, Samaritan president and CEO, in a statement.”
  • Modern Healthcare tells us,
    • “Elevance Health is distinguishing itself from other insurers by proactively, and publicly, railing against high costs it says are driven by providers. 
    • “The insurer announced last year that its Anthem Blue Cross Blue Shield commercial plans would penalize healthcare facilities with a fee up to 10% if out-of-network clinicians are deployed for elective surgeries. That policy was soon expanded to additional states.
    • Last month, Elevance Health tightened the screws again by becoming the first insurer to require that hospitals identify and charge correct rates for off-campus care.
    • “Elevance Health’s site-of-care policy represents a “relatively consumer-protective attempt at reducing spending,” said Christine Monahan, an associate research professor at the Georgetown University Center on Health Insurance Reforms.
    • “Hospitals, however, have already begun to challenge the restrictions, which they deem as unilaterally imposed on them in spite of their contracts with the insurer. It’s possible more health systems will sue, said John Barnes, a partner at law firm Davis Wright Tremaine who represents providers on issues concerning insurance contracts.”
  • and
    • “Zocdoc, a virtual marketplace for booking providers, has acquired insurance technology company Sohar Health.
    • “The deal marks Zocdoc’s first acquisition since launching in 2007, according to a Wednesday press release. Zocdoc declined to disclose the financial terms of the acquisition, which closed on Oct. 2.
    • “Sohar’s platform automates insurance benefits eligibility checks.”
  • MedTech Dive informs us,
    • “Steris said Monday it struck a $2.1 billion deal to acquire Xodus Medical for its portfolio of consumable healthcare products. 
    • “Xodus’ portfolio includes Pink Pad patient-positioning products and the See Sharp laparoscopic cleaning and defogging device. The company expects annual sales to hit $245 million this year.
    • “Buying Xodus “makes sense” for Steris because it expands the company’s healthcare consumables offering with high-growth, high-margin products, Needham analysts said in a note to investors.”
  •  and
    • “Agilent said Tuesday that it has agreed to buy digital pathology software provider Proscia for $240 million upfront.
    • “The deal, which includes up to $30 million in milestones, will give Agilent control of technology that connects slide scanners, laboratory information systems and other parts of the pathology workflow.
    • “Agilent’s deal comes months after Roche agreed to buy PathAI for up to $1.05 billion. Evercore ISI analysts noted that Agilent “got the rights to play in this market at a lower price point.”
  • Beckers Health IT points out,
    • “The American Hospital Association, American Medical Association, Anthropic and Elevance Health are participating in a national workgroup developing recommendations for how state medical boards should oversee AI in medical practice, a spokesperson for the Federation of State Medical Boards confirmed to Becker’s.
    • “FSMB announced the workgroup in May to develop recommendations and/or model guidelines for state medical boards, particularly regarding AI systems that perform clinical functions with limited or no direct physician supervision. The effort comes as companies test how AI can be used in diagnosis, prescribing and other clinical functions, and as states propose and implement regulatory sandbox frameworks, according to FSMB’s news release.
    • “The group met in Washington in early October, the FSMB spokesperson confirmed to Becker’s.”
  • Fierce Healthcare adds,
    • “Johns Hopkins Medicine is teaming up with OpenEvidence to advance the use of artificial intelligence in medical education and clinical care.
    • “OpenEvidence and Johns Hopkins executives provided Fierce Healthcare with a first look at the partnership news.
    • “The health system and academic institution will partner with OpenEvidence to develop what they describe as “human-first AI systems” that combine the best available evidence with a patient’s medical history and Johns Hopkins’ clinical best practices to support care delivery. Sophisticated AI will help clinicians reason through that information more quickly, contextualize it, and make the best decisions for their patients, executives said.”

Midweek update

David Ermer–Agentic & Generative AI, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Fierce Healthcare reports,
    • “A group of 17 senators penned a letter to U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. seeking more information on recent appointments to a key health panel—echoing concerns of key medical groups.
    • “In the letter (PDF), the legislators called the appointments a “major break from the historic makeup of [the] U.S. Preventive Services Task Force (USPSTF) membership,” as it is typically comprised of primary care practitioners and preventionists.
    • “Kennedy named eight new members to the USPSTF in mid-September—five of whom were specialists and one healthcare finance expert. The new appointments came months after Kennedy dismissed the panel’s vice chairs and did not replace five other members after their terms expired at the start of 2026.
    • “Legislators expressed concerns over an April 23 Federal Register notice seeking nominations for the panel, given the change in nominee parameters—outside of primary care and preventive medicine—and timeline. The letter notes members in specialty areas have “always played a role” in the panel’s operations, though primarily in consultant roles in part to avoid conflicts of interest.”
  • The American Hospital Association News relates,
    • “The Health Resources and Services Administration Maternal and Child Health Bureau has released the latest data from the National Survey of Children’s Health. The survey provides national and state-level data on children’s physical and mental health, healthcare access and quality, special healthcare needs, adverse childhood experiences and family and community well-being. HRSA also plans to release a data brief featuring survey findings on the health and well-being of children living in rural communities.”
  • Beckers Hospital Review tells us,
    • “CMS is penalizing 2,334 hospitals, about 80% of those evaluated, under the Hospital Readmissions Reduction Program in fiscal 2027, according to new CMS data. The penalties took effect on Oct. 1.” * * *
    • “The share of hospitals receiving no penalty will drop to 19.8% (578 hospitals) from 21.8% (641) in 2026. The bulk of hospitals, 71.8% in fiscal 2027 compared with 70.1% in 2026, will see penalties below 1%.”

From the U.S. Food and Drug Administration front,

  • Reuters reports,
    • “The US Food and Drug Administration has expanded the use of Novartis’ (NOVN.S), drug to treat adults with ​a chronic skin condition that causes recurring itchy welts [Rhapsido], ‌the Swiss drugmaker said on Wednesday.
    • “The condition, called symptomatic dermographism, is a form of chronic hives in which scratching, rubbing or ​friction on the skin can trigger itchy welts.
    • “The ​approval adds to momentum for the drug, remibrutinib, which investors ⁠have increasingly focused on after recent late-stage failures of the ​company’s cholesterol drug pelacarsen and muscle-wasting disease therapy del-desiran ​increased scrutiny of its pipeline.”
  • PharmExec relates,
    • “The FDA has approved Pfizer’s Tukysa (tucatinib) in combination with trastuzumab and pertuzumab as maintenance treatment for adults with unresectable locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have completed induction therapy, the company announced Oct. 7.1
    • “The decision moves the oral therapy from later-line use into the first-line setting, where it is added to an established antibody pair.”
  • Stock Titan adds,
    • “vTv Therapeutics (Nasdaq: VTVT) received FDA Orphan Drug Designation for HPPD, its investigational oral treatment for sickle cell disease.
    • “Preclinical studies at Augusta University used the Townes sickle cell disease mouse model. HPPD was orally active and well tolerated, increased fetal hemoglobin, and reduced oxidative stress and red blood cell sickling. Fetal hemoglobin increases were time- and dose-dependent, with effects comparable to or exceeding hydroxyurea, the current standard fetal hemoglobin-inducing therapy.
    • “vTv said the designation supports partnering discussions for HPPD while it continues to prioritize cadisegliatin, its lead late-stage type 1 diabetes program. HPPD remains investigational; its safety and efficacy have not been established, and approval or commercial availability is not guaranteed.”

No Surprises Act News

  • The Coalition against Surprise Medical Billing reports,
    • “After a new federal rule slashed the administrative fee for initiating IDR disputes by 87% — from $115 to just $15, nearly 400,000 disputes were initiated in July 2026 alone. This 24% jump in just one month is one of the latest signals that the IDR process has veered even further off course and needs an overhaul.
    • “IDR was supposed to be a last resort for resolving legitimate payment disputes between providers and health plans. Instead, organizations built to file disputes at scale have turned it into a profit center — initiating over 7 million disputes between April 2022 and the end of July 2026. The result is more administrative burden, more unnecessary costs, and more pressure on the employers, workers, and families who ultimately pay the bill. IDR costs have increased to $22.4 billion, according to recent data published in Health Affairs.” * * *
    • “An overused IDR system drives up costs across the entire healthcare system. Every dispute requires employers and health plans to spend resources processing and defending claims, while arbitration outcomes drive higher payments that ultimately put pressure on premiums and healthcare costs.”

From the fraud, waste, and abuse front,

  • Beckers Hospital Review reports,
    • “Federal prosecutors have secured guilty pleas or prison sentences in at least six durable medical equipment fraud cases tied to more than $1.5 billion in claims since late May, and CMS has barred 11 DME suppliers from Medicare Advantage payments.
    • “The cases follow a familiar pattern: telemarketers target Medicare beneficiaries, practitioners sign orders for orthotic braces without examining patients and DME companies bill Medicare for equipment no one needed. Becker’s tracked DME fraud actions against 10 people between March 24 and May 26.
    • “CMS imposed a six-month moratorium on new Medicare enrollment for certain DME, prosthetics, orthotics and supplies providers in February, citing more than $1.5 billion in suspected fraudulent billing stopped in 2025.  The moratorium expired Aug. 27, according to the American Orthotic & Prosthetic Association. On Sept. 8, CMS barred 11 DMEPOS suppliers from future Medicare Advantage and Part D payments, citing more than $3.4 billion in suspected fraudulent billing in 2025 and 2026.”
  • STAT News adds,
    • “In a warning to life sciences companies, the Department of Justice last week issued a new directive for combating fraud that made a point of noting the agency will pursue violations of a federal law that tightly regulates the pharmaceutical industry.
    • “Typically, the agency has pursued health fraud cases centered on providers, clinics, home health agencies, and hospices. By expressly including the Federal Food, Drug, and Cosmetic Act in the directive, the National Fraud Enforcement Division appears to be placing drug and device makers, among others, more clearly in its crosshairs.
    • “This is a subtle but significant expansion of their jurisdiction,” said Kevin Lowell, a member of the Miller & Chevalier law firm, who spent a decade at the DOJ, where he most recently had been a deputy chief in the National Fraud Enforcement Division’s health care fraud section.
    • “The directive brings into focus all of the FDA-regulated companies and the division is pointing to a specific statute that refers to a part of the health care industry that has not previously been a focus. … And it’s one of first items on the list of priorities” for investigating potential fraud.”

From the judicial front,

  • STAT News reports,
    • “The brand drug industry’s main trade group is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries.
    • “The Pharmaceutical Research and Manufacturers of America said Wednesday that it had filed a complaint in the U.S. District Court for the District of Columbia asserting that the “most-favored nation” pilot in Medicare Part B exceeds Medicare’s statutory authority.
    • “The pilot, called GLOBE, is not expected to have much impact because the administration exempted all but a handful of companies in return for their agreement to voluntary deals to charge Medicaid MFN prices. 
    • “But it would set a precedent that the industry wants to nip in the bud. PhRMA says the voluntary agreements are acceptable, but the mandatory GLOBE program is not.
    • “The administration is still considering a separate pilot, called GUARD, that would require MFN prices in Medicare Part D. The status of that proposal is not clear.”
  • Beckers Hospital Review adds,
    • “Hospitals affiliated with Nashville, Tenn.-based HCA Healthcare have sued multiple insurers over alleged claim denials and reimbursement issues in 2025 and 2026. These cases contribute to a broader landscape of legal battles between providers and insurers.
    • “Most recently, seven hospitals filed a lawsuit Oct. 5 against Anthem Blue Cross and Blue Shield Georgia, part of Elevance Health. The complaint argued the insurer is on the hook for more than $501,213 in reimbursement, alleging underpaid or denied claims.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “The overall mortality rate for U.S. patients with cardiovascular disease (CVD) has improved significantly in the last two decades, according to new findings published in JACC.[1] However, despite the continued efforts of cardiologists and other cardiovascular care professionals, disparities remain for certain racial and/or ethnic groups. 
    • “This new analysis represents a county-by-county dive into the heart health of Americans from 2000 to 2019. Data came from both the U.S. National Vital Statistics System and the National Center for Health Statistics.
    • “In total, the study’s authors found that CVD mortality rates “varied substantially” from one county to the next. There were often considerable differences in the same state. This highlights the importance of ensuring all patients, no matter where they live, receive high-quality care. 
    • In 2019, the overall age-standardized mortality rate (ASMR) for CVD in the United States was 237.8 deaths per 100,000 adults. The ASMR was the highest for Black patients and the lowest for Asian patients.” 
  • Beckers Clinical Leadership relates,
    • “A coalition of Texas health systems, professional organizations and community groups has launched a five-year plan to eliminate cervical cancer in the state.
    • “The Texas Lone Star Cervical Cancer Elimination Plan 2027-2032 was developed by the Cancer Alliance of Texas Cervical Cancer Elimination Priority Area Workgroup, according to an Oct. 7 news release from Houston-based University of Texas MD Anderson Cancer Center.
    • “Cervical cancer elimination is defined as fewer than four new cases per 100,000 women a year. Texas’ current cervical cancer rate is 9.5 cases per 100,000, with rates in some counties reaching 15 to 21 per 100,000. Uninsured, rural, border and minority communities carry the heaviest share of cases, the release said.
    • “The plan is built on three pillars: vaccination, screening, and timely follow-up, diagnosis and treatment. Read the full plan here.” 
  • The American Hospital Association News tells us,
    • “As part of the AHA’s Opportunities for Innovations in Rural Maternal Care initiative, a recent Commonwealth Fund blog discusses strategies hospitals can use to sustain maternal care within the communities they serve. Hear from Julia Resnick, AHA senior director of health outcomes and care transformation, and Aisha Syeda, AHA senior program manager of health outcomes and care transformation, on ways to solidify leadership commitment, build a skilled workforce, strengthen partnerships and address community needs. LEARN MORE“
  • The latest post of NIH Research Matters covers the following topics:
    • Device helps people with paralysis communicate
      • “A brain-computer interface linked to a virtual avatar helped people with paralysis express speech and body language at the same time.
      • “Translating neural signals for both types of communication could enable people with paralysis to express themselves more fully.”
    • Improving lung cancer detection
      • “Researchers developed a protein-based MRI contrast agent that could detect a common lung cancer in mouse models and determine if it spread to other organs.
      • “With further development, the approach could help doctors detect lung cancer earlier and tailor treatment to the needs of each patient.”
    • Estimating cognitive impairment risk, timing
      • “Combining blood p-tau217 levels together with APOE4 gene status improved predictions of dementia risk.
      • “The findings may help doctors better assess patients’ risk for cognitive impairment and estimate when symptoms may develop.”
  • Radiology Business points out,
    • “A minimally invasive, image-guided procedure can provide lasting relief for carpal tunnel syndrome, according to new research published in RSNA’s Radiology. 
    • “This common occupational ailment is frequently encountered among the middle-aged, leading to morbidity and loss of work hours. Common carpal tunnel syndrome management strategies may include conservative therapy or surgical decompression, experts note. 
    • “However, image-guided interventions such as steroid shots or nerve hydrodissection—which involves carefully injecting fluid around the impacted area—have emerged as alternatives for mild to moderate cases. Researchers in India recently aimed to investigate the efficacy of these options, sharing their findings Tuesday. 
    • “Most of our patients had been suffering from carpal tunnel syndrome for months to years and did not get much relief despite trying various treatments like pain medications, splints, lifestyle modification and corticosteroids,” study co-author Anupama Tandon, MD, a professor with the University College of Medical Sciences and Guru Teg Bahadur Hospital in Delhi, India, said in a statement Oct. 6. “It came as a pleasant surprise to find that a simple procedure of dissecting the median nerve under ultrasound guidance with normal saline provided them long-term relief.”
  • Per Genetic Engineering and Biotechnology News,
    • “The results of research headed by a team at the University of Birmingham suggest that inflammatory conditions in the brain, including traumatic brain injury (TBI) and degenerative diseases such as Alzheimer’s disease and Parkinson’s disease, could be targeted with an existing developmental drug.
    • “Using live cultures of human brain cells and slices of brain tissue obtained during neurosurgery, the researchers, headed by Nicholas Barnes, PhD, professor at the University of Birmingham College of Medicine and Health, investigated the role of the P2X7 receptor, which is responsible for triggering inflammatory signaling. Their findings revealed that these P2X7 receptors drive the release of cytokines involved in controlling inflammation. By blocking this receptor with a specific antagonist, the team was able to significantly reduce the inflammatory response in human brain tissue.
    • “The team suggests that their results could open the door to treating a wide spectrum of chronic neurological conditions, including TBI, neurodegenerative diseases, and even psychiatric disorders such as depression and psychosis, which are increasingly understood to have a neuroinflammatory component.”

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

  • Beckers Payer Issues reports,
    • “Harbor Health, an Austin, Texas-based insurer that also runs its own medical clinics, plans to acquire 27 Village Medical primary care clinics in the Houston area.
    • “The deal is expected to close at the end of the year, according to an Oct. 6 news release, and financial terms were not disclosed. Once the deal closes, Harbor will operate nearly 70 clinics and more than double its count of physicians and advanced practice providers.
    • “The company offers large employer plans in 29 Texas counties, including the four Houston-area counties. It will also offer individual and family plans on the Texas exchange in 13 of those counties for 2027.
    • “Village Medical is the clinic brand of VillageMD, which Walgreens previously owned a majority stake in. VillageMD has operated as a standalone company since private equity firm Sycamore Partners took Walgreens private in August 2025, while Cigna continues to hold a minority stake. Harbor also bought 32 VillageMD clinics in Austin, Dallas, El Paso and San Antonio in September 2025.” 
  • Fierce Healthcare relates,
    • “Cigna is rolling out a new patient experience platform that aims to harness the power of data to drive greater personalization.
    • “Called Health Sense, the tool brings together information on an individual’s health needs, medical coverage, pharmacy benefits, cost exposure and other previous interactions with the health plan. This allows for more complete context, as the insurer’s clinical teams offer tailored experiences to members.
    • “Having a more complete picture of the patient also allows Cigna’s clinicians and care managers to collaborate more effectively with a member’s treating providers, the company said. It surfaces insights for the member about next steps, potential costs for care, any supports available in-network and potential preparation for an upcoming appointment.
    • “Cigna plans to roll out Health Sense in early 2027, with an initial focus on members with cancer or cardiometabolic conditions.”
  • Beckers Behavioral Health tells us,
    • “Mental healthcare, including care for substance use disorders, accounted for 7% of total U.S. healthcare expenditures from 2021 to 2023, Medscape reported Oct. 7. Annualized mental health spending totaled $174 billion, compared with $2.5 trillion in overall healthcare expenditures captured by the survey.
    • “Researchers analyzed data from the 2021 to 2023 Medical Expenditure Panel Survey, which represents the civilian noninstitutionalized U.S. population. The analysis included 67,532 person-year observations, including 15,407 involving outpatient mental healthcare. The study, led by Carlos Blanco, MD, PhD, of the National Institute on Drug Abuse in Bethesda, Md., was published online Sept. 30 in JAMA Psychiatry.”
  • Modern Healthcare informs us,
    • “Prime Therapeutics, one of the largest U.S. pharmacy benefit managers, aims to shift to upfront drug pricing and away from a complicated rebates-based system that critics say increases patient costs. 
    • “The company intends to offer its clients — health insurers and employers — what it calls a net cost model for 2028, Chief Executive Officer Mostafa Kamal said in an interview Wednesday. He said patients should get the discounts that drug companies pay when they fill their prescriptions at the pharmacy. Prime seeks to keep its clients’ overall costs the same or lower than the current setup.” 
  • BioPharma Dive adds,
    • “Caribou Biosciences, one of the first companies founded to advance CRISPR gene-editing technology in medicine, is discontinuing research, laying off staff and looking for “strategic alternatives” because it can’t raise the money to continue.
    • “The decision means the end of Caribou’s work on two “off-the-shelf” CAR-T cancer therapies, one of which was ready for Phase 3 testing. “Despite the progress we’ve made, the current financing environment for allogeneic CAR-T cell therapies has made it increasingly challenging to secure the capital necessary to responsibly advance these programs,” Caribou CEO Rachel Haurwitz said in a statement Tuesday.
    • “The company’s board will consider mergers, acquisitions or other transactions related to the company as a whole or for its assets, Caribou said. In the meantime, a “substantial reduction in workforce” will be mostly completed by the end of the year, the company added.”
  • Healthcare Dive points out,
    • “Telehealth company Teladoc Health is adding new artificial intelligence capabilities to its virtual care platform for hospitals and health systems, it announced Wednesday.
    • “The new capabilities include a “contactless” approach to remotely monitoring patients’ vital signs and an AI scribe that will record and transcribe clinical encounters to create notes, according to the announcement.
    • “The scribing tool is now available but only select customers can currently use the vitals monitoring feature in private preview. The latter is expected to be released broadly in December.”
  • Becker’s Hospital Review notes,
    • “The American Medical Association has honored 92 hospitals, health systems and medical groups through its 2026 Joy in Medicine program.
    • “The Joy in Medicine program recognizes healthcare organizations for their commitment to “reduce burnout and improve the professional fulfillment physicians find in caring for patients,” according to an Oct. 7 news release from the AMA.
    • “There are three levels of recognition in the program, gold, silver and bronze, which are valid for two years. Find the hospitals and health systems honored in the AMA’s 2025-26 Joy in Medicine program here.” 
  • McKinsey & Co. discusses the AI powered future of healthcare.
    • “AI won’t replace clinicians, but it can improve quality, increase access, and reshape the workforce, payments, and patient volumes. Today, AI can perform some 16 to 22 percent of US outpatient care.”

Nobel Prize

  • The Wall Street Journal reports,
    • “Henri Kagan and Kenso Soai were awarded the 2026 Nobel Prize in Chemistry for breakthroughs that have helped advance the development of modern pharmaceuticals.
    • “Kagan, of France’s Université Paris-Sud, and Soai, who is based at Tokyo University of Science, will share the 12 million Swedish kronor, or roughly $1.2 million, prize.
    • “The pair’s research relates to a concept called homochirality, which is the tendency of living systems to use just one of two possible mirror-image forms of a molecule. It’s important for the synthesis of small molecules in drugs that can interact with amino acids and sugars in the body in powerful ways.
    • “Thanks to Henri Kagan and Kenso Soai, we now know how homochirality can emerge,” the Royal Swedish Academy of Sciences said Wednesday. “Their discoveries have been decisive for chemists who design reactions for the manufacture of pharmaceuticals.”

Weekend update

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

Simplicity is a virtue.

From Washington, DC,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

No Surprises Act News

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

From the fraud, waste, and abuse front,

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

From the public health and medical / Rx research front

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

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

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

Midweek update

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

Simplicity is a virtue.

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Tuesday report

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

Simplicity is a virtue.

From Washington, DC

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

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

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

From the judicial front,

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

From the fraud, waste, and abuse front,

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

From the public health and medical / Rx research front,

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

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

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

Friday report

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

Simplicity is a virtue.

From Washington, DC

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

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

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front

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

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

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

Monday report

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

Simplicity is a virtue.

From Washington, DC

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

From the U.S. Office of Personnel Management front

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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