Thursday report

Patient safety

Thursday report

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

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The government shutdown is expected to continue into next week as the Senate is expected to adjourn Oct. 23 with no plans to vote this weekend. The chamber Oct. 22 failed for a 12th time to advance the House-passed continuing resolution to extend government funding. The House remains out of session with no plans to return at this time. Lawmakers remain at an impasse.”
  • and
    • “The Senate Committee on Health, Education, Labor and Pensions Oct. 23 held a hearing discussing the 340B Drug Pricing Program and its growth and impacts on patients. The AHA provided a statement to the committee in support of the program and highlighted benefits for patients and hospitals, such as lowering drug costs and subsidizing chronic underpayments from Medicare and Medicaid.
    • The AHA also discussed the impact of 340B in rural communities. “Most rural hospitals lose money when providing critical medical services needed in their communities and therefore rely on 340B savings to remain operational and provide specialty care,” the AHA wrote. “If these services were unavailable in their communities, rural patients would be forced to drive far distances to access the same level of care, which for many would be impossible.”
  • The Senate did adjourn until Monday late this afternoon.
  • Federal News Network adds,
    • “A Republican measure to immediately pay federal employees who are working without pay under the shutdown failed to advance in the Senate on Thursday. But some lawmakers still appeared optimistic about reaching a bipartisan agreement on paying federal employees within the next few days.
    • “Democrats largely voted down the GOP’s “Shutdown Fairness Act,” resulting in a vote of 54-45 on the Senate floor. The Republicans’ motion on the bill failed to reach the 60 votes required to “invoke cloture” — a type of vote that limits debate to more quickly move legislation to a final vote.
    • “Three Democrats — Sens. John Fetterman (D-Pa.), Jon Ossoff (D-Ga.) and Raphael Warnock (D-Ga.) — voted alongside Republicans on the motion. Sen. Tim Sheehy (R-Mont.) did not vote.” * * *
    • “Despite Thursday’s failed votes, Sen. Ron Johnson (R-Wis.), the lead co-sponsor on the Shutdown Fairness Act, expressed optimism for reaching a bipartisan agreement to pay federal employees while the shutdown continues.
    • “We’re basically in agreement here,” Johnson told reporters. “I’m willing to add furloughed workers, and now it’s just kind of down to the reductions in force … I don’t want to completely constrain the President, but I don’t mind making sure that Congress has a say in this as well.”
    • “I’m actually quite hopeful — I think we can fix it over the weekend,” Johnson added. “This could open up a path to opening the government as well.”
  • and
    • “The Centers for Medicare & Medicaid Services is temporarily bringing furloughed employees back to work to help individuals sign up for health insurance plans during the open enrollment period.
    • “CMS told employees in an email obtained by Federal News Network that it is bringing back its furloughed employees, starting Monday, Oct. 27.
    • “The agency said it will repurpose some of its funding to ensure furloughed and excepted employees are paid on time for days worked during the open enrollment period.
    • “CMS said all these employees “will be paid for the days you work” or take approved leave, beginning on Oct. 27. Employees working these days will receive a partial paycheck on Nov. 7.”
  • The Wall Street Journal notes,
    • “Lawmakers failed to provide a last-minute reprieve for air-traffic controllers and other federal workers who are set to miss their next paychecks due to the government shutdown, with legislation failing in the Senate and Republicans warning they didn’t expect any financial rescue from the administration.
    • “The expected lapse in pay exacerbates concerns over possible shortages of air-traffic controllers, a job that requires long, intense hours and sophisticated training. But worries about air travel could also help drive Republicans and Democrats to find a way out of the funding impasse, now into its fourth week. Absenteeism and air-travel problems played a central role in bringing about the end of the record monthlong lapse in President Trump’s first term.” * * *
    • “In 2019, the strain on air-traffic controllers was widely seen as helping bring the government shutdown to an end, after staffing shortages and sick calls began disrupting flights. So far, U.S. flight cancellations and delays have stayed generally in line with their level during the same period last year, according to data from FlightAware.
    • “Union officials say hardships are growing for airport workers.”
  • Tammy Flanagan, writing in Govexec, lets us know that “the government shutdown has raised lots of questions about the retirement process, and retirement benefits, for federal employees while agencies remain closed. Here are some of the most pressing answers.”
  • AHIP and the Blue Cross Blue Shield Association has posted a No Surprises Act survey concluding that
    • “The Independent Dispute Resolution (IDR) process itself is costly, diverting funds plans could otherwise have spent on patient care or used to lower premiums and patient cost-sharing.
    • “The vast majority of out-of-network claims covered by the NSA are resolved through prompt payment without dispute or further negotiation.
    • “IDR is being overused by some providers who submit high volumes of disputes, many of which are ineligible, which adds costs to the health care system.”

From the Food and Drug Administration front,

  • Biopharma Dive reports,
    • “The Food and Drug Administration has approved GSK’s multiple myeloma drug Blenrep, officially ending the hiatus of a medication pulled from the U.S. market three years ago.
    • “Yet the agency on Thursday issued a mixed decision in clearing the drug’s return. It approved Blenrep’s use alongside one regimen involving another myeloma medicine, Velcade, but not in combination with another therapy called Pomalyst. It also cleared Blenrep in people whose multiple myeloma has returned, or hasn’t responded, after at least two prior lines of therapy, instead of one, as GSK had requested.
    • “Still, in a statement, GSK Chief Scientific Officer Tony Wood referred to the decision as a “significant milestone.” Wood added that “there is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse and re-treating with the same mechanism of action often leads to suboptimal outcomes.”
    • “The clearance completes a turnaround for Blenrep, which was initially approved in 2020 but traveled an unusual path since.”
  • Yahoo relates,
    • Coca-Cola has issued a recall of three of its most popular soda brands after discovering potential metal fragments in certain batches. If you’ve got a cold soft drink chilling in your kitchen, there are key batch codes you’ll want to check—especially since thousands of cans have already been pulled from store shelves. Read on to find out whether your soda is affected, what to do if it is, and how to stay safe. * * *
    • “According to a Coca-Cola spokesperson, the recall was limited to select regions of Texas, specifically the McAllen/Rio Grande Valley and San Antonio areas. The company confirmed that no products outside these locations were impacted.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A new analysis of a major clinical trial affirmed that Wegovy, the popular obesity drug, lowers the risk of major heart issues like heart attacks and strokes in some adults, but showed that weight loss could not fully explain the cardiovascular benefits.
    • “How else, exactly, the drug protects the heart remains a mystery.
    • “Obesity is intricately linked with poor heart health, and losing excess weight can blunt the risk of cardiovascular concerns. But the analysis, published on Wednesday in The Lancet, found that a shrinking waist size — a measure of shedding belly fat — was responsible for only around a third of the observed cardiovascular benefits in people who took Wegovy. In their first 20 weeks of taking the drug, patients experienced cardiovascular benefits no matter how much weight they lost.
    • “As it stands now, we do not know how to account for that other roughly two thirds of the benefit,” said Dr. Michael Lincoff, a professor emeritus of medicine in the department of cardiovascular medicine at the Cleveland Clinic and an author of the paper.”
  • BioPharma Dive adds,
    • “Shares of Ventyx Biosciences, a San Diego-based drug company, nearly doubled Thursday morning after the company said an experimental medicine it’s been studying in people with obesity showed significant effects on cardiovascular risk factors in a mid-stage trial.
    • “The medicine, code-named VTX3232, failed to help trial participants lose more weight when given alone or as an add-on therapy to semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy. It did, however, significantly reduce biological markers of inflammation, fat levels and liver illness, Ventyx said late Wednesday.
    • “Analysts argue the results lend more support to Ventyx’s approach of fighting disease by focusing on an inflammasome known as NLRP3. Shares of a rival company also targeting NLRP3, BioAge Labs, jumped more than 30% in early trading Thursday.”
  • Per MedPage Today,
    • “Researchers estimated the long-term cardiovascular effects of sugar rationing in the United Kingdom dating back to World War II.
    • “Early life during this period of restricted sugar intake was tied to lower cardiovascular risks in adulthood after age 40.
    • “Risk reductions reached 20% for cardiovascular disease and 25% for myocardial infarction for people who spent the first 1,000 days after conception under sugar rationing.”
  • The American Medical Association lets us know what doctors wish patients knew about healthy eating.
  • Medscape lets us know what doctors wish patients knew about GLP-1 drugs and oral health.
  • Per Health Day,
    • “Poor blood sugar control in adolescents with type 1 diabetes (T1D) increases the risk for future complications, according to a study published in the October issue of Diabetes Research and Clinical Practice.
    • “Chris Moran, from Monash University in Australia, and colleagues examined the 30-year glycemic trajectory in children with early-onset T1D. The analysis included 30 children with T1D (1990 to 1992) participating in the Cognition and Longitudinal Assessment of Risk Factors study.”
  • Genetic Engineering and Biotechnology News relates,
    • “The link between an extra copy of chromosome 21 and Down syndrome (DS) has been well established for decades. What has not been clear was the genetic basis for the congenital heart defects that are associated with nearly half of babies born with Down syndrome. Now a new study in mice published in Nature describes how HMGN1 disrupts DNA’s packaging and regulation and how this impacts molecular levels in healthy heart development. Details of the work are published in a paper titled “Myocardial reprogramming by HMGN1 underlies heart defects in trisomy 21.”
    • “The work is the result of a collaboration involving scientists from Gladstone Institutes, Sanford Burnham Prebys, and elsewhere. As explained in the paper, the link to HMGN1 was made using human pluripotent stem cell and mouse models of Down syndrome. Specifically, “single-cell transcriptomics showed that trisomy 21 shifts human [atrioventricular canal] cardiomyocytes towards a ventricular cardiomyocyte state,” the scientists wrote. Then, “a CRISPR-activation single-cell RNA droplet sequencing screen of chromosome 21 genes expressed during heart development revealed that HMGN1 upregulation mimics this shift, whereas deletion on one HMGN1 allele in trisomic cells restored normal gene expression.” 
    • “According to Sanjeev Ranade, PhD, assistant professor in the Center for Cardiovascular and Muscular Diseases and Center for Data Science and Artificial Intelligence at Sanford Burnham Prebys, “what our paper did was address a major unresolved question: Yes, three copies of chromosome 21 causes DS, but why? What are the genes on chromosome 21 that are bad if you have them in three copies? How in the world do you try to find those genes?” Ranade is the first author on the paper and also a co-corresponding author. 
    • “While this study was done in mice, there are obvious benefits for research in people. Learnings from this study “could pave the way for treatments to help prevent heart malformations in people with Down syndrome and related heart defects, which would be a major win for patients and their families,” said Deepak Srivastava, MD, president and senior investigator at Gladstone, a pediatric cardiologist at University of California, San Francisco (UCSF). Srivastava is the senior author on the paper and one of its corresponding authors.”
  • and 
    • “Ewing sarcoma is one of the most common bone cancers seen in children, and if it spreads, it can be deadly. A study headed by researchers at the Institute of Mother and Child, Warsaw, have now found that combining first line therapy for Ewing sarcoma with a drug called pazopanib, which was originally developed for renal cell carcinoma, demonstrated striking success in treating a small group of young patients. 85% of the treated patients survived two years after diagnosis, and there was no disease progression for two-thirds of patients. The team calls for larger studies which can develop this treatment further.”
  • Beckers Hospital Review shares a survey of U.S. state based on the readiness to address the healthcare needs of their elderly populations.
    • “Hawaii is the most prepared state to address the healthcare needs of the U.S.’s aging population, while Oregon is the least, according to an analysis by Seniorly and CareScout. 
    • “Seniorly examined each state across three dimensions — population trends, financial readiness and healthcare capacity — to devise the ranking.”
  • The Washington Post answers reader questions about using artificial intelligence as a healthcare guide.
    • “Younger doctors, in particular, are turning to the technology for help with diagnosis and treatment decisions. Two medical educators told me that nearly all of their students and residents use OpenEvidence, a free AI tool trained on medical literature. Wolters Kluwer UpToDate, the gold-standard clinical reference used by as many as 90 percent of physicians, has also added AI features that generate tailored recommendations for specific patient scenarios.
    • “My advice is to frame your curiosity as collaboration, not challenge. You might say, “I was trying to learn more about menopause and found this information. What do you think of it?” You might even ask your doctor if she uses AI herself. That question can open the door to understanding whether the discomfort stems from the technology itself or from a deeper resistance to patients taking a more active role in their care.”

From the healthcare business front,

  • Beckers Hospital Review reports,
    • “GLP-1 prescribing in the US may have reached a plateau, new data suggests. 
    • “Prescribing rates remained stable from June to September, according to an analysis of EHR data from researchers at Truveta — a platform that includes de-identified patient data from more than 900 hospitals to support medical research advancements.
    • “In June, the overall prescribing rate for GLP-1s was 6.22%. By September, that figure was 6.5%, marking a 4.6% increase. The findings were published Oct. 14 in the preprint server medRxiv.“
  • and
    • “Patient experience scores across U.S. hospitals are rebounding slowly after pandemic-era declines. 
    • “According to a Press Ganey analysis of 10.5 million patient encounters released earlier in 2025, “recommend the hospital” scores rose from 69 in 2024 to 70.4 in early 2025, signaling a modest uptick in trust and satisfaction. Scores at medical practices and ambulatory surgery centers have each increased by several points since 2019, while inpatient scores have fallen by 2.2 points in the same period.
    • “The analysis results suggest that while patient experience is improving overall, the biggest strides are occurring outside hospital walls. Outpatient environments are benefiting from targeted digital investments, streamlined access and better communication, while inpatient settings still struggle with coordination, predictability and information flow.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released its new “Launch Price and Access Report,” finding that drug launch prices continue to rise at a rate that exceeds inflation, gross domestic product (GDP) growth, and overall healthcare costs.
    • “ICER’s analysis focused on “net price,” or the actual price paid after rebates and discounts, offering crucial information to policymakers, given that most previous analyses of drug pricing trends focus on the publicly available “list price,” which does not always reflect the actual price paid.
    • “The report, using net prices, found that the inflation-adjusted median annual launch price of drugs increased by 51% from 2022 to 2024, while the annual list price increased 24% during the same period. Even after accounting for the differences in the mix of drugs approved each year (by holding certain characteristics constant, like the number of gene therapies approved), the annual net launch price increased by 33% per year.
    • “ICER also conducted an in-depth review of the 23 drugs in scope that had been previously reviewed by ICER. The analysis indicated that aligning the prices of these therapies with ICER’s Health Benefit Price Benchmark (HBPB) could have saved approximately $1.3 to $1.5 billion in the first-year post-approval alone – savings that could have been redirected to higher-value drugs and services.’
  • Healthcare Dive tells us,
    • “Molina cut its 2025 earnings guidance for the third time this year on Wednesday, citing doggedly high medical costs particularly in its Affordable Care Act plans.
    • “The insurer now projects adjusted earnings per share of $14 this year, down from its prior estimate of “no less than” $19 from July. The earnings reduction is despite Molina now believing it will bring in higher premiums this year.
    • “Molina also posted third quarter results on Wednesday that beat analyst expectations on revenue but missed on earnings. The insurer’s stock plummeted 19% in aftermarket trading following the results.”
  • Fierce Healthcare informs us,
    • “Community Health Systems’ (CHS’) third-quarter performance blew past Wall Street’s expectations with year-over-year same-store gains and shareholder earnings that landed on the right side of zero.
    • “The Franklin, Tennessee-based company is the first of its for-profit peers to report this earnings season. Its stock is trading well above its closing value after hours—a change in pace from last quarter’s stumble.
    • “We were pleased with operating and financial results for the quarter, which generally met our expectations,” Kevin Hammons, president and interim CEO, said in Thursday afternoon’s release on the quarter’s performance.”
  • Per Fierce Pharma,
    • “Even as Roche executives on Thursday espoused confidence in the company’s resilience and growth potential over the next several years, a mix of exchange rate fluctuations and lackluster pharmaceutical sales led to a worse-than-expected third quarter for the Swiss drug giant.
    • “For the first nine months of 2025, Roche’s overall sales grew 7% year over year at constant currencies to 45.9 billion Swiss francs (nearly $58 billion), the company announced Thursday. The bulk of that growth can be attributed to the company’s pharmaceutical division, which has clocked sales growth of 9% at constant exchange rates over the nine-month stretch.
    • “As in previous earnings periods, Roche’s pharma momentum was attributed to the recent performance of Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus.”
    • “Roche’s earnings release reported the company’s sales performance from January through September, and in that span, all five of those franchises charted revenue increases. But looking at the period from July through September specifically, that shine lost some of its luster.”

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Bloomberg Law reports,
    • “Political pressure points set to hit around Nov. 1 could force lawmakers to negotiate an end to the government shutdown.
    • “Funding shortfalls and other deadlines for health care, military pay, and nutrition benefits will collide on or around the first of next month, potentially creating new bipartisan urgency for lawmakers to end the shutdown set to enter its fourth week on Wednesday.” 
  • The American Hospital Association News tells us,
    • The AHA provided a statement for a Senate Special Committee on Aging hearing today on shoppable services that improve health outcomes and lower costs. The AHA asked Congress to take certain steps to address hospital price transparency requirements, including streamlining existing policies that prioritize reducing potential patient confusion and unnecessary regulatory burden on providers; ensuring pre-service estimates are as accurate as possible; continuing to seek input from patients, providers and payers on ways to make more patient-centered federal price transparency policies; and refraining from advancing additional legislation or regulations that could further confuse or complicate providers’ ability to provide meaningful price estimates and add unnecessary costs. In addition, the AHA urged Congress to reject any efforts to expand site-neutral payment cuts.”
  • Per a Senate news release,
    • “On Wednesday, October 29, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on how we can better deliver lifesaving cures to patients and maintain American dominance in medical innovation.”
  • Modern Healthcare informs us,
    • “The Trump administration chose a new leader for a federal health research funding organization that focuses on high-risk, high-reward programs, after firing its previous head in February.
    • “Alicia Jackson, a health technology entrepreneur who used to work for the Defense Department, was appointed director of the Advanced Research Projects Agency for Health, according to the Department of Health and Human Services, confirming an earlier Bloomberg News report.
    • “The agency known as ARPA-H is part of HHS and one of several U.S. government research accelerators that support cutting-edge projects unlikely to attract traditional funding or commercial investment. It has programs in precision cancer therapy, manufacturing personalized genetic medicines, fixing brain damage and enabling joints to heal themselves, according to its website.”
  • The Paragon Health Institute released a paper suggesting ways to improve the CMS Innovation Center.
    • “The CMS Innovation Center has largely failed to produce models with savings or quality improvements. Despite savings projections in the tens of billions, the center’s models have generated more than $5 billion in costs in its first decade.
    • “The voluntary nature of demonstrations, flawed benchmarks, and an inadequate focus on savings have produced poor results.
    • “The Innovation Center’s new strategy seeks to rectify past issues with a renewed focus on evidence-based prevention, patient empowerment, choice and competition, and savings.
    • “Congress and CMS can reform the Innovation Center by prioritizing limited and true demonstrations that are primarily mandatory and based in markets with a focus on definitive savings.
    • “If these reforms are not adopted or are not successful, the Innovation Center should be terminated.”

From the Food and Drug Administration front,

  • Beckers Hospital Review points out,
    • “The FDA is requiring updated labeling for tranexamic acid injection to emphasize the risk of serious harm, including death, if administered incorrectly via spinal injection.
    • “Tranexamic acid injection is indicated for short-term use — two to eight days — in patients with hemophilia to reduce or prevent hemorrhage during and after tooth extraction. It is supplied in single-dose ampules and vials containing 1,000 milligrams in 10 milliliters, and in sodium chloride injection bags with 1,000 milligrams in 100 milliliters.
    • “The agency is mandating a boxed warning, a contraindication for neuraxial (spinal and epidural) use, and revised dosage instructions specifying that the drug must be administered intravenously, according to an Oct. 21 news release. The FDA took action after reviewing cases in which tranexamic acid was mistakenly administered intrathecally or epidurally instead of local anesthetics such as bupivacaine or lidocaine. These errors resulted in prolonged hospitalizations and deaths.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reportshttps://www.cidrap.umn.edu/measles/us-measles-cases-top-1600-south-carolina-outbreak-grows,
    • “The Centers for Disease Control and Prevention (CDC) said today the country has seen 1,618 confirmed measles cases so far in 2025, 22 more than last week. And in South Carolina, a measles outbreak linked to two schools with low student vaccination rates has grown by 4 cases. 
    • “The total represents the most US infections since 1992, when the CDC reported 2,237 measles cases.
  • The New York Times adds
    • Just as one large measles outbreak peters out in the United States, another outbreak of the virus has taken off along the border of Utah and Arizona.
    • The new outbreak began in August and has sickened more than 100 people, making it the second-largest cluster of cases in the country this year. A majority of the cases are in unvaccinated people. * * *
    • “There are several parallels between the current situation at the Utah-Arizona border and the outbreak that exploded from the Western edge of Texas in January: Both started in rural towns with a sizable population of children who had not been immunized against measles, mumps and rubella. And in both outbreaks, the virus traveled to a neighboring state and took root in similarly vulnerable pockets.” * * *
    • “In the current outbreak, cases have been clustered in Colorado City, Ariz., and Hildale, Utah — adjoining cities with historical ties to the Fundamentalist Church of Jesus Christ of Latter-day Saints, a polygamist offshoot of the Mormon Church. However, local public health officials said the virus had spread beyond members of that religious group into the broader community, where vaccination rates have dropped steeply since the pandemic.
    • “In Mohave County, Ariz. — which now has the second-highest case count of 2025, only after the Texas county at the center of the Southwest outbreak — roughly 90 percent of kindergartners were fully vaccinated against measles in the 2019-20 school year.
    • “But by the 2024-25 school year, the vaccination rate had dropped to 78 percent. (About 95 percent of a community needs to be vaccinated to stem the spread of measles, which is one of the most contagious known viruses.)
    • “Data from Southwest Utah tell a similar story: Vaccination rates dropped nearly eight percentage points over the course of the pandemic to about 78 percent.”
  • The New York Times also relates,
    • “Bird flu is back. After a quiet summer, the virus has hit dozens of poultry flocks, resulting in the deaths of nearly seven million farmed birds in the United States since the beginning of September. Among them: about 1.3 million turkeys, putting pressure on the nation’s turkey supply in the run-up to Thanksgiving.
    • “Reports of infected wild birds have also surged this fall, and three states — Idaho, Nebraska and Texas — have identified outbreaks in dairy cows.
    • “The virus often flares up in the fall as wild birds begin migrating south; this year, the uptick is occurring during a government shutdown, as federal agencies that are typically involved in the response are working with skeletal staff.”
  • Per MedPage Today,
    • “A large study suggested that older women who took at least 4,000 steps 1-2 days per week had lower risks of death and heart disease.
    • “Participants who reached that threshold 3 or more days per week had a 40% lower mortality risk.
    • “Researchers said the key factor was the total number of steps per day — not how many days per week a certain number was reached.”
  • and
    • “With new research shedding light on how our food affects respiratory function and the progression of disease, interest in the role of diet in lung health is increasing. The reasoning behind it is based on the possible anti-inflammatory qualities of some diets and the fact that some lung conditions, such as asthma and chronic obstructive pulmonary disease (COPD), are inflammatory diseases, Maria Sfika, MD, pulmonary resident at Attikon University Hospital in Athens, Greece, told Medscape Medical News.
    • “However, at the European Respiratory Society (ERS) 2025 International Congress, in Amsterdam, researchers presented a nuanced picture. While a healthy diet generally supports better lung function and can improve control of certain conditions, its benefits may be mediated through weight control.”
  • and
    • “Glovadalen (UCB), an investigational brain-penetrant D1 receptor positive allosteric modulator (D1 PAM), is both safe and effective for patients with advanced Parkinson’s disease (PD), new research showed.
    • “Results from the phase 2 ATLANTIS trial, which included more than 200 patients with PD and significant daily motor fluctuations, showed that those who received oral glovadalen plus standard care for 10 weeks had a greater reduction in number of OFF hours per day than those who received matching placebo, meeting the primary endpoint.
    • “Additionally, significantly more participants receiving active treatment reported feeling better on the Patient Global Impression of Change (PGI-C) of PD symptoms scale than those receiving placebo.”
  • Per Genetic Engineering and Biotechnology News,
    • “By the time patients start seeking care for multiple sclerosis (MS), the disease has already been damaging their brain for years. But until recently, scientists didn’t understand which brain cells were being targeted or when the injury began.
    • ‘Now, by analyzing thousands of proteins found in the blood, scientists at the University of California, San Francisco (UCSF), have created what they view as the clearest picture yet of when the disease attacks the myelin sheath that covers the nerve fibers. It shows that the immune system begins attacking the brain even earlier than previously had been thought.
    • “The study “Myelin injury precedes axonal injury and symptomatic onset in multiple sclerosis,” published in Nature Medicine, measured debris from these attacks in a person’s blood, along with the signals that coordinate the immune system to go on the attack. It lays out, for the first time, the sequence of events that eventually lead to the disease.
    • “The discovery could lead to new ways to diagnose multiple sclerosis—and possibly one day prevent it, noted the scientists.” 
  • The New York Times reports,
    • “A new large-scale analysis found that the short-term cardiovascular and metabolic side effects of antidepressants vary widely by drug, but the ones most commonly prescribed in the United States are linked to relatively mild issues.
    • “Tens of millions of U.S. adults take antidepressants for mental health conditions such as depression and anxiety. Like any medication, antidepressants have well-established side effects for some people. Researchers at institutions including King’s College London and the University of Oxford wanted to better understand just how much those side effects differed from drug to drug.
    • “The new study, published Tuesday in The Lancet, is among the largest meta-analyses to compare some of the short-term side effects of antidepressants. The findings may help millions of doctors work with their patients to determine the right choice for them in a sea of options.”
  • Per STAT News,
    • “Moderna said Wednesday afternoon that its experimental vaccine for cytomegalovirus, a cause of disability in newborns, failed in a Phase 3 trial, a significant setback for a company already facing pressure from Wall Street and the federal government.
    • “The CMV vaccine had been the company’s lead program prior to the Covid-19 pandemic. Leadership had repeatedly said it could bring in between $2 billion and $5 billion in peak annual sales. Analysts polled by Visible Alpha forecast peak sales of $1.6 billion for the product.

From the HLTH 2025 Conference

  • Healthcare Dive reports,
    • “A top aide for HHS Secretary Robert F. Kennedy, Jr. made waves at the HLTH conference when he accused players across the healthcare industry of capitalizing off of chronic illnesses and turning a blind eye to potential root causes of the conditions, like diet.
    • “The problem is that most people in this room are just predominantly making money off more sick patients. And that’s just an economic fact,” Calley Means, an influential advisor to Kennedy, said.
    • “Means spoke on a panel Tuesday about the Make America Healthy Again movement, which centers around reducing chronic disease by reforming food, health and science systems. A groundswell of public support for MAHA helped usher President Donald Trump into office, and the president created a MAHA Commission through an executive order in February.”
  • and
    • “American Nurse Association President Jennifer Mensik Kennedy says industry pressures are coalescing to worsen nursing shortages.
    • “Studies estimate the U.S. will need 1.2 million new registered nurses by 2030 to meet care demands. The ANA, American Hospital Association and health systems have doggedly called for solutions to the growing labor crisis for years, with some health systems opting to acquire their own nursing schools to ensure sufficient pipelines of talent.
    • “Still, Kennedy says barriers remain to educating, recruiting and retaining quality nurses. Some problems are old hat — for example, it’s difficult to entice nurses to take a pay cut to become a nurse educator. However, new challenges are of the cultural and political moment, according to Kennedy, including developing strategies to retain nurses burnt out by patients peddling misinformation.”
    • The article also features a Healthcare Dive interview with the ANA President.
  • and
    • “The window for digital health initial public offerings has opened after a long period of stagnation, but the outlook isn’t entirely smooth for firms looking to make the leap to the public markets, experts said at the HLTH conference this week.
    • “Few digital health companies have entered the public markets in recent years, in sharp contrast to a surge of health technology IPOs in 2021. However, many firms that went public during the pandemic-era funding boom struggled in the spotlight — and some collapsed altogether. 
    • “There’s plenty of uncertainty in healthcare right now, making it more challenging for companies to decide to make a move, Robbert Vorhoff, managing director and global head of healthcare at private equity firm General Atlantic, said during a panel discussion at HLTH.”
  • Modern Healthcare adds,
    • “Virta Health Chief Commercial Officer Laura Walmsley said in a panel on Monday at HLTH that some employers are looking for GLP-1 alternatives that can be as effective as weight loss drugs. She said Virta Health, a virtual diabetes care company, has sold nutrition-only therapy solutions to employers looking to forgo covering GLP-1s for weight loss.
    • “Most employers are not covering GLP-1s for weight loss,” Walmsley said. “Greater than 50% are not covering them.”
  • and
    • “Cleveland Clinic is using AI to identify patients who may need surgery. The health system hopes to reduce costs and limit care complications by treating patients before conditions worsen.
    • “Predictive modeling can sift through claims data to flag a patient who may need spinal surgery, a heart procedure, bariatric surgery or other treatment. The technology has increased referrals to Cleveland Clinic and bolstered partnerships with employers and insurers, said Meghan Cassidy, senior director of sales and product development at Cleveland Clinic, in an interview at HLTH on Tuesday.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The cost of health insurance rose steeply for a third year in a row in 2025, reaching just under $27,000 for a family plan, according to an annual survey from the nonprofit KFF, which provides the broadest picture of U.S. employer health coverage. 
    • “That is a 6% increase from the year before and builds on two prior years of 7% gains. The cost is rising faster than inflation, and economists and business leaders said it could bite into employment and wage growth. 
    • “If healthcare costs go up faster than the economy in general, that means there’s less money left over to go to wages,” said Gary Claxton, a senior vice president at KFF. 
    • “J.H. Berra Paving Co., in St. Louis, is struggling with this trade-off. The company is facing a 15% health-insurance rate increase this year, on top of last year’s increase, said John O’Connor, a risk manager for the company. That extra cost is likely to put a lid on wage increases for the company’s workers, O’Connor said.
    • “The KFF survey, which includes more than 1,860 employers and was completed earlier this year, offers a detailed snapshot of workplace insurance. Nearly half the U.S. population gets health coverage through a job.”
  • Modern Healthcare relates,
    • “MultiCare Health System and Samaritan Health Services look to combine the two nonprofit health systems, they announced Wednesday.
    • “The boards of the organizations approved a membership-substitution agreement that would make Tacoma, Washington-based MultiCare the parent company of Corvallis, Oregon-based Samaritan. MultiCare operates 13 hospitals and more than 300 primary, urgent, pediatric and specialty care facilities, while Samaritan operates five hospitals, more than 80 clinics and multiple health plans. 
    • ‘The systems plan to sign a definitive agreement in the coming weeks and close the proposed deal in mid-2026, pending customary regulatory approvals, according to a news release. A MultiCare spokesperson said the organizations in July signed a nonbinding letter of intent but did not disclose financial details.”
  • Per STAT News,
    • “As pharma companies and President Trump tout initiatives to sell branded medications directly to cash-paying consumers, some entrepreneurs have seized on a potential business opportunity — pitching a new model for employers to help their workers pay for medications without using insurance. 
    • “Take the blockbuster obesity treatments Wegovy and Zepbound, for example. Many employers don’t cover them, since they find them too expensive to add to their health plans. But now that the drug manufacturers Eli Lilly and Novo Nordisk have started selling the products directly to patients at about $500 a month, employers are being incentivized by startups to subsidize part of the cash price for their workers.
    • “Their pitch is this: Employers can pay less than they would if they covered the drugs through insurance and, with a subsidy, employees can get the treatments at a lower cost than if they paid the full cash price on their own. 
    • “One company, RxSaveCard, is charging employers a set fee to help them set up this model. CEO Chris Crawford said in an interview that the company has seen interest take off as more pharma companies launch direct-to-consumer sales and that hundreds of employers have either already signed up for RxSaveCard or will be adopting the model next year.
    • “Another new company, Andel, announced this week that it will launch a platform that will adopt a similar model for GLP-1 treatments and eventually for other branded drugs as well.”
  • Per Reuters,
    • Walmart (WMT.N) will become the first U.S. retailer to sell Abbott Laboratories’ (ABT.N), over-the-counter continuous glucose monitor Lingo in physical stores, an Abbott spokesperson said on Tuesday.
    • Abbott’s device, which was previously available only at HelloLingo.com and Amazon, will now be sold in Walmart’s 3,500 stores across the U.S.
    • Continuous glucose monitor makers such as Abbott, Dexcom (DXCM.O) and Medtronic (MDT.N) are riding a surge in demand as diabetes awareness rises, insurance coverage expands and patients embrace finger-prick-free technology.
  • Per BioPharma Dive,
    • “Brain drug developer Alkermes could spend billions of dollars in a new deal that, if completed, would give the company a marketed medication to build out its burgeoning sleep business.
    • “Alkermes on Wednesday said it has agreed to purchase Ireland-based Avadel Pharmaceuticals for $18.50 per share, reflecting a 3.5% premium to the latter company’s closing share price the day prior. Avadel’s main asset, Lumryz, is similar to the sleep drug Xyrem, which at its peak generated close to $2 billion in annual sales. Lumryz is already approved to treat excessive daytime sleepiness or cataplexy, a symptom of one form of narcolepsy that’s characterized by a sudden loss of muscle strength.”
  • and
    • Takeda [a Japanese pharmaceutical manufacturer] is turning to China to fuel its oncology pipeline, announcing Wednesday a wide-ranging collaboration with Innovent Biologics that could be worth more than $11 billion.
    • Through the alliance, Takeda is gaining rights outside of Greater China to two experimental cancer therapies in late-stage testing. It also acquired an option to a third in earlier development. Innovent, which is based in Suzhou, China, will receive $1.2 billion up front as well as a $100 million equity investment at a 20% premium to its current trading price on the Stock Exchange of Hong Kong. 
    • Takeda could add another $10.2 billion to the deal, if all three molecules hit a variety of development milestones.
  • Per MedTech Dive,
    • “The number of procedures performed with Intuitive Surgical’s flagship da Vinci system picked up pace in the third quarter, lifting the robot maker’s sales and earnings above Wall Street forecasts.
    • “Total procedures increased year over year by 20% worldwide, compared to 17% in the second quarter, which was the rate for all of 2024. Meanwhile, revenue rose 23% year over year to $2.51 billion, surpassing the average analyst forecast by $10 million, according to Citi Research.
    • “Procedure demand has been healthy,” Intuitive CEO Dave Rosa said on Tuesday’s earnings call.”

Tuesday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • As Congress still appears far from reaching a spending agreement to end the partial government shutdown, hundreds of thousands of federal employees are expecting to miss their first full paychecks this Friday.
    • “Many excepted and furloughed federal employees received partial paychecks around Oct. 10, for the pay period that ended Oct. 4 — although they were only paid for workdays through Sept. 30.
    • “But while the shutdown drags on, some members of Congress are looking at other options to try to secure pay and benefits for certain employees impacted by the funding lapse.
    • “One Republican-led bill aims to provide immediate and regular compensation to excepted employees, who are continuing to work throughout the shutdown without pay. Sen. Ron Johnson (R-Wis.), who introduced the Shutdown Fairness Act [(S. 3012)] last week, said while the shutdown remains ongoing, Congress should “at least agree to pay all the federal employees that are forced to continue working.”
    • “The 2025 Shutdown Fairness Act is a permanent fix that will ensure excepted workers and our troops are paid during a shutdown,” Johnson said.
    • “Despite the Republican bill being teed up for consideration in the Senate this week, some Democrats, including House Minority Leader Hakeem Jeffries, have already indicated they would not support the legislation, since it provides pay for only a portion of the federal workforce.” 
    • FEHBlog note — As long as Speaker Johnson can hold his majority in the House, the Democrats
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 21 announced that it has instructed all Medicare Administrative Contractors to lift a hold and begin processing claims dated Oct. 1 and later for those paid under the Medicare Physician Fee Schedule, ground ambulance transport claims and federally qualified health center claims. This also includes lifting holds on telehealth claims that CMS can confirm are for behavioral health services. CMS directed all MACs to continue temporary claims hold that began Oct. 1 for other telehealth services and acute Hospital Care at Home claims, as the shutdown approaches the start of a fourth week.”
  • Federal News Network tells us,
    • “The Office of Personnel Management is eyeing July 4, 2027, to fully launch a new governmentwide human resources system.
    • “In a new request for proposals released Friday, OPM details a much more specific plan of action to modernize and centralize 119 distinct core federal human resources systems across the government.
    • “The ideal ‘to be’ state is a single, pan-government core human capital management (HCM) system that gives the federal government full, real-time visibility into its workforce and drives effective workforce management on behalf of the American taxpayer,” wrote OPM Director Scott Kupor in a blog post on Monday. “Key to this ideal is our hypothesis that one system at governmentwide scale will drive significant per-user cost savings over the current siloed, duplicative, ad-hoc landscape.”
    • “Kupor said these 119 systems and the 44,000 people required to use them cost about $5.5 billion a year to manage, and are costly, error-prone and leads to unnecessary delays in enabling a seamless transition to retirement.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has confirmed that a safety concern it was investigating with Johnson & Johnson MedTech’s Automated Impella Controllers (AICs) has resulted in a Class I recall. The agency reserves Class I recalls for issues that could potentially lead to a serious injury or death.
    • “This latest issue with the Johnson & Johnson MedTech AICs revolves around “purge retainer failures,” including cracks, that customers have experienced during purge disc insertion or removal.”
  • Reuters informs us,
    • “The U.S. Food and Drug Administration has approved a new eye therapy from Glaukos Corp (GKOS.N), giving patients a less painful option to treat a progressive condition that can severely affect vision, the company said on Monday. * * *
    • “The approval makes the therapy, called Epioxa, the first FDA-cleared treatment that does not require removal of the eye’s outer protective layer, known as the corneal epithelium.
    • “Epioxa was approved to treat keratoconus, a condition in which the cornea thins and changes shape over time, making vision blurry and increasing the risk of blindness.
    • “Glaukos said it expects Epioxa to be commercially available in the first quarter of 2026.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Food allergies in children dropped sharply in the years after new guidelines encouraged parents to introduce infants to peanuts, a study has found.
    • “For decades, as food allergy rates climbed, experts recommended that parents avoid exposing their infants to common allergens. But a landmark trial in 2015 found that feeding peanuts to babies could cut their chances of developing an allergy by over 80 percent. In 2017, the National Institute of Allergy and Infectious Diseases formally recommended the early-introduction approach and issued national guidelines.
    • “The new study, published Monday in the journal Pediatrics, found that food allergy rates in children under 3 fell after those guidelines were put into place — dropping to 0.93 percent between 2017 and 2020, from 1.46 percent between 2012 and 2015. That’s a 36 percent reduction in all food allergies, driven largely by a 43 percent drop in peanut allergies.
    • “The study also found that eggs overtook peanuts as the No. 1 food allergen in young children.”
  • The American Journal of Managed Care points out,
    • “Body size and metabolic factors—including body mass index (BMI), basal metabolic rate (BMR), body surface area (BSA), and weight—significantly influence psoriasis severity and response to treatment, a study has found.1 Patients with higher measurements were less likely to achieve strong improvement with biologic therapies, suggesting a critical role for personalized dosing in clinical management, particularly for fixed-dose biologics like ustekinumab.
    • “This multicenter, prospective study is published in Journal of Translational Medicine.
    • “Our findings provide important insights into the interplay between body size, metabolic parameters, and psoriasis,” wrote the researchers of the study. “The observation that higher values of BMI, BSA, BMR, and body weight were more common in individuals with higher educational attainment, males, and those reporting smoking or alcohol use may reflect lifestyle- and nutrition-related influences on metabolic status.”
  • Per Cardiovascular Business,
    • “Back in 2023, the American Heart Association (AHA) coined a new term to describe the close relationships between cardiovascular disease (CVD), kidney disease, type 2 diabetes and obesity: cardiovascular-kidney-metabolic (CKM) syndrome.
    • “CKM syndrome involves nearly every major organ in the body, the AHA explained. Patients with CVD often face a heightened risk of developing kidney disease, type 2 diabetes or obesity. Also, patients with any of those three conditions may face a heightened risk of CVD. 
    • ‘More than two years later, the AHA’s message has yet to make a significant impact on the general public. However, new survey data suggests there is a reason to be hopeful.
    • “According to an August 2025 survey, just 12% of U.S. adults have heard of CKM syndrome. The good news, though, is that 79% of respondents said it is important to know more about the way these different health conditions interact with one another. And 72% indicated they were interested in learning more.”
  • Per MedPage Today,
    • “Maternal respiratory syncytial virus (RSV) vaccination during pregnancy and infant RSV immunization — either alone or combined — appeared to be safe and effective at boosting neutralizing RSV antibodies, according to interim results from a randomized, open-label phase IV clinical trial.”
  • and
    • “Giving oseltamivir (Tamiflu) to children hospitalized with influenza cut their risk of ICU admission by nearly one-third and significantly shortened their lengths of stay (LOS), according to a retrospective cohort study.”
  • and
    • “Patients with metastatic hormone-sensitive prostate cancer (mHSPC) lived significantly longer without disease progression with the addition of radioligand therapy to hormonal treatment, a large, randomized trial showed.”
  • and
    • “Adding another twist to the ongoing debate about the effects of weight-loss drugs on vision, a retrospective cohort study linked GLP-1 receptor agonists to a lower risk of legal blindness in patients with type 2 diabetes and risk for cardiovascular disease.”
  • The Wall Street Journal takes us “Inside Priscilla Chan’s Multibillion-Dollar Wager to Outsmart Disease.” As the initiative she co-founded celebrates its 10-year anniversary, Chan is pursuing a wildly ambitious goal: unlocking the hidden causes of disease.

From the HLTH 2025 Conference

  • Modern Healthcare reports,
    • “Risant Health has reduced care variation by using hospitals’ electronic health records to guide treatment, a model it hopes to expand to other hospitals as the Kaiser Permanente-backed nonprofit venture grows, Geisinger Health, Kaiser and Risant executives said during a Tuesday panel at HLTH.
    • “Risant, which was formed in April 2024 when Kaiser acquired Geisinger and folded it into Risant, has integrated what executives describe as value-based care guides into EHRs. A clinician can select a list of the most common conditions for certain specialties and order evidence-based tests and follow-ups via the EHR.
    • “The guides have helped standardize care across Geisinger hospitals, said Dr. Benjamin Hohmuth, chief medical informatics officer at the Danville, Pennsylvania-based health system.
    • “Whether you live in California, are a Geisinger patient in Pennsylvania or a Cone Health patient in North Carolina, you should be receiving the same care and the bias should lean toward more comprehensive primary care,” he said. “It leads to faster resolution for patient concerns, lower cost sharing for patients and frees up specialty access.”
    • “The new protocols have helped reduce the number of primary care visits associated with specialty referrals by about 7% over the last year at Geisinger, freeing up capacity for about 10,000 annual specialty care appointments, and increased virtual and primary care utilization, Hohmuth said.”
  • and
    • “UnitedHealth Group Inc. is testing a new system to streamline how medical claims are processed, an early example of what the company says is the potential for artificial intelligence to smooth out friction in billing.
    • “The system, dubbed Optum Real, aims to distill health plans’ complex rules around what is covered into information that doctors, and billing staff can use in real time to tell whether a claim is likely to be paid. 
    • “It’s been in place at Allina Health, a 12-hospital system based in Minneapolis, since March, where two departments have used it to connect to UnitedHealthcare, the health conglomerate’s insurance division. It’s already reduced claims denials meaningfully across more than 5,000 visits in Allina’s outpatient cardiology and radiology departments, said Dave Ingham, chief digital and information officer for the hospital group.” * * *
    • “Optum Real is speeding up prior authorization requests and helping some patients get care faster, Allina Health’s Ingham said. It’s also reducing headaches for billing and coding staff by flagging claims that need more documentation, for example, before they’re denied. That lets Allina fix the problem without a lengthy back-and-forth with the insurer.
  • Healthcare Dive notes,
    • “Medical billing tech firm Cedar launched a tool Monday that aims to help patients enroll in and maintain Medicaid coverage as the healthcare sector braces for major cuts to the safety-net insurance program.
    • “The product, called Cedar Cover, identifies patients who may be eligible for Medicaid, reminds beneficiaries of upcoming eligibility checks, helps them manage care denials and connects them to medication co-pay assistance, the company announced at the HLTH 2025 conference in Las Vegas. 
    • “The tool comes months after President Donald Trump signed a massive tax and policy law that includes historic cuts to Medicaid. “This bill is going to directly drive increases in uninsured patient care,” Seth Cohen, president of Cedar, said at HLTH.”
  • and
    • “Generation X and Millennials are more interested in utilizing artificial intelligence tools in healthcare as the two generations are increasingly squeezed by caregiving responsibilities for children and aging parents, according to a survey by PwC. 
    • “More than 70% of Gen X and Millennials are currently using or interested in AI-assisted diagnosis products leveraged and reviewed by doctors, compared with 56% of the total population, according to the report released at the HLTH conference Monday.
    • Additionally, 73% of the two generations are using or interested in AI-backed care navigation tools, compared with 53% of the overall population. “They just have a lack of time,” said Thom Bales, principal and health services advisory leader at PwC. “And so, I think that when you see their openness, it is a call to simplifying their life.”
  • Per Fierce Healthcare,
    • “Oscar Health has unveiled its slate of plans available for the 2026 open enrollment window, including a new product launch designed for members who are navigating menopause.
    • “The plan, called HelloMeno, was built in partnership with Elektra Health, a virtual menopause care provider, and offers $0 primary care, gynecologist and behavioral health visits. Members who enroll in this plan option will also receive no-cost labs, hormone therapy, insomnia medications and bone density scans, per an announcement.
    • “Through Elektra, members can connect to its network of experts at any time and are estimated to save $900 per year on their healthcare costs. The plan also allows for low-cost treatment options for autoimmune conditions like rheumatoid arthritis or Crohn’s disease.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance posted revenue and profit growth in the third quarter as the Indianapolis-based insurer brought in higher premiums and kept medical costs for its members in check.
    • “Elevance raked in net income of $1.2 billion on revenue of $50.1 billion in the quarter, up 17% and 12% year over year, respectively. Elevance’s stock ticked up in premarket trade after the results were released Tuesday morning — but it dropped again after executives implied that profit growth could shrink in 2026 during a call with investors later in the morning.
    • “Elevance said it expects a decline in Medicaid margins as state payment rates continue to not cover members’ medical costs — a bad sign for other managed care companies with a large presence in the safety-net insurance program, like Centene and Molina. Elevance also plans to invest “several” hundred million dollars in its health services division Carelon, artificial intelligence capabilities and Medicare Advantage star ratings, which could stifle earnings growth next year.”
  • Per MedTech Dive,
    • “Hologic said Tuesday that it has agreed to be acquired by funds managed by Blackstone and TPG in a take-private deal valuing the company at up to $18.3 billion.
    • “Hologic, which makes diagnostic tools including mammography machines and cervical cancer screening tests, would be delisted from Nasdaq upon completion of the transaction. The company would keep its brand and current headquarters in Marlborough, Massachusetts.
    • “The acquisition is expected to close in the first half of 2026, subject to shareholder and regulatory approval. Hologic’s board unanimously approved the deal.”
  • Beckers Hospital Review shares a non-exhaustive list of “72 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2025,” and offers a look at Microsoft’s healthcare moves.
  • The International Foundation of Employee Benefit Plans offers it medical stop loss premium survey while Brown and Brown posts its 2025 PBM industry and market update.
  • Healthcare IT News lets us know that the American Medical Association has created a new Center for Digital Health and AI.  “The AMA says the new initiative is designed to ensure physicians are involved in the development and deployment of artificial intelligence technologies and to help shape AI policy conversations.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Republicans and Democrats both see a likely path to ending the government shutdown, involving extending enhanced Affordable Care Act healthcare subsidies for a year or longer. But there are a series of reasons why no deal has emerged, even with costs set to surge for more than 20 million Americans.
    • “The shutdown is now entering its third full week, with no serious talks under way. The House passed its short-term bill to fund the government through Nov. 21 and has been out of town since. Democrats have repeatedly blocked the measure in the Senate, where Republicans have a 53-47 majority, but 60 votes are required to advance the legislation.”
  • Per a Senate news release,
    • “Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and John Hickenlooper (D-CO) introduced the 21st Century Dyslexia Act, legislation that incorporates the modern, scientific understanding of dyslexia into federal statute and prevents the harm unidentified dyslexia can inflict on young students.
    • “Despite dyslexia impacting one in five Americans, students are rarely tested,” said Dr. Cassidy. “This legislation brings a common-sense approach to dyslexia, ensuring students have the resources they need to reach their full potential.”
    • “Better early screening, more awareness, and modern tools will help make sure kids with dyslexia are diagnosed early. These resources are inexpensive and immensely valuable. I know – I lived it,” said Senator Hickenlooper.
    • “U.S. Representatives Erin Houchin (R-IN), Julia Brownley (D-CA), and Bruce Westerman (R-IN) introduced the companion legislation in the U.S. House of Representatives.” * * *
    • “Read the full bill text here.”
  • Tammy Flanagan, writing in Govexec, explains “what to know when your child ages out of federal health coverage. Children can stay on a parent’s FEHB or PSHB plan until 26, but understanding the 31-day extension, conversion options and Temporary Continuation of Coverage is key to avoiding gaps.” The FEHBlog’s advice is to move your adult child to their employer sponsored health plan which should be a snap.
  • FedWeek tells us,
    • “An inspector general report has cited some positives for USPS finances but also notes that its financial picture in recent years has benefitted from several special infusions of funding from Congress that it called “unique events.” * * *
    • “First Class mail volume “is not expected to return to levels previously seen in the early part of the 20th century,” it said, and “ultimately, future retirement obligations will need to be funded.”
    • “Eliminating the prefunding requirement temporarily alleviated the Postal Service’s financial burden but did not change the fact that once the [Postal Service Retiree Health Benefits Fund] runs out of funds, the Postal Service is responsible for funding its share of the healthcare premium costs for its retirees as the costs are incurred,” it said.”
  • Per a Labor Department news release,
    • “U.S. Secretary of Labor Lori Chavez-DeRemer today joined President Trump at the White House as the President announced the third most-favored-nation agreement, which will result in significant cost savings on fertility treatments. On the heels of the President’s announcement, the U.S. Department of Labor, joined by the Departments of Health and Human Services and Treasury, issued guidance designed to cut burdensome red tape, helping employers understand how to structure health benefits to expand access to fertility treatments like In Vitro Fertilization or IVF.” * * *
    • “Following the President’s announcement today, the Departments of Labor, Health and Human Services, and Treasury issued new guidance in line with the President’s Executive Order 14216, “Expanding Access to In Vitro Fertilization.” The guidance clarifies existing categories of excepted benefits that employers can use to offer fertility benefits, including fertility treatment through a specified disease or illness policy, or offering reimbursement for those services through an excepted benefits health reimbursement arrangement.
    • “The departments also intend to propose rulemaking aimed at providing additional ways that certain fertility benefits may be offered as a limited excepted benefit. The departments are also considering whether to modify the standards under which supplemental health insurance coverage provided by a group health plan, including a supplemental benefit for fertility coverage, will be considered to satisfy the conditions for being an excepted benefit.”
  • According to a Paragon Health Institute report,
    • “The Inflation Reduction Act caused Medicare Part D stand-alone prescription drug plan premiums to increase nearly 600 percent from 2023 to 2026.
    • “To disguise this premium spike, the Biden administration abused Medicare’s “demonstration” authority. Despite the Biden administration’s $5 billion bailout of the Inflation Reduction Act’s failed policies, the number of plans declined by over half from 2021 to 2025.
    • “The Trump administration has sensibly mitigated this abuse, phased down the bailout, and reduced distortions in the Medicare Part D program.”
  • The Postal Service Health Benefits Program relies heavily on stand-alone Medicare Part D prescription drug plan for benefit cost savings.

From the Food and Drug Administration front,

  • Per an HHS press release,
    • “The U.S. Food and Drug Administration today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing.
    • “Voucher recipients will receive a decision within 1-2 months following filing of a complete application for a drug or biologic. In addition, sponsors will receive enhanced communications with review staff throughout the development process prior to their final submission and during the review period. If necessary, FDA scientists reserve the right to extend the review time if an application is incomplete, there are manufacturing violations, or as they otherwise deem appropriate.” * * *
    • “The following products were selected:
      • “Pergoveris for infertility
      • “Teplizumab for Type I diabetes
      • “Cytisinicline for nicotine vaping addiction
      • “DB-OTO for deafness
      • “Cenegermin-bkbj for blindness
      • “RMC-6236 for pancreatic cancer
      • “Bitopertin for porphyria
      • “Ketamine for domestic manufacturing of a critical drug for general anesthesia
      • “Augmentin XR for domestic manufacturing of a common antibiotic.”
  • Per MedPage Today,
    • “The FDA is warning about the potential for serious injuries with radiofrequency (RF) microneedling for skin procedures following reports of burns, scarring, disfigurement, and nerve damage.
    • “The agency said it is working with manufacturers of the class II medical devices with the hopes of identifying mitigation strategies. “While the FDA’s evaluation is ongoing, we are asking patients, caregivers, and healthcare providers to report any complications to the use of these devices for dermatologic or aesthetic skin procedures.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “The first US case of locally acquired clade 1 mpox has been reported in Long Beach, California, according to city and state health authorities.
    • “The clade 1 case is the nation’s first in a person with no recent travel history and the seventh clade 1 case in the country. The patient required hospitalization and is now isolating and recovering at home, the City of Long Beach news release said.
    • “Public health officials are reviewing the patient’s potential source of exposure and conducting contact tracing. No other cases have been identified.
    • “While the overall risk of mpox clade I exposure to the public remains low, we are taking this very seriously and ensuring our community and health care partners remain vigilant so we can prevent any more cases,” Long Beach Mayor Rex Richardson said in the release. “This underscores the importance of continued surveillance, early response, and vaccination.”
  • The New York Times reports,
    • “A study, published in the journal JAMA Ophthalmology, analyzed the number of eye injuries that brought pickleball players to hospital emergency rooms from 2005 to 2024. Dr. Tsui and his colleagues extrapolated from a database of injuries that relies on a nationally representative sample of hospitals.” * * *
    • “While there were just over 3,100 pickleball-related eye injuries that brought players to emergency rooms between 2014 and 2024, over one-third of them — some 1,262 injuries — occurred in 2024 alone.
    • “Players 50 and older, who were more likely to sustain ocular injuries than younger players, accounted for 70 percent of all eye injuries. Age-related decreases in muscle mass, bone density and balance may have made them more vulnerable, the authors said.” * * *
    • “Eye protection is not required for professional or casual play, the authors of the study noted. USA Pickleball, the sport’s governing body in the United States, last year disapproved of a rule change that would require players to wear eye protection in its tournaments, saying it would be difficult to enforce.
    • “Pickleball clubs and courts also do not require eye protection. But the American Academy of Ophthalmology last year recommended players wear eyewear that meets the American Society for Testing and Materials F3164 guidelines, which are the standard for most racket sports.”
  • United Healthcare, writing in LinkedIn, ponders whether GLP-1 drugs are real-life wonder drugs.
    • “GLP-1 drug sales are up 500% since 2018, with growth accelerating as new uses emerge.
    • “Beyond diabetes and obesity, they show promise for Alzheimer’s, cancer and more.
    • ‘GLP-1 users also saw a 44% drop in hospitalizations from stroke, heart attack and heart failure.”
  • The Genetic Engineering and Biotechnology News relates,
    • “Although it well known that the human gut contains a large and diverse array of bacteriophages, a functional understanding of the phage–host interactions is limited. This is, in part, due to a lack of cultured isolates available. Now, a new study uncovers hundreds of new phages within our gut, information that could eventually reshape the gut microbiome, potentially influencing gut health and the progression of various disease states.
    • “Published in Nature in the paper, “Isolation, engineering and ecology of temperate phages from the human gut,” the study is the first of its kind and uses a large-scale, culture-based approach to isolate and study temperate bacteriophages in the human gut.
    • “This is a foundational study that changes how we think about and study the viruses within the human gut,” said Jeremy Barr, PhD, professor at the Monash University’s School of Biological Sciences. “We found that compounds produced in human gut cells can wake up dormant viruses inside gut bacteria. This could have major implications for gut diseases like inflammatory bowel disease (IBD), where inflammation and cell death are common.”
  • Per MedPage Today,
    • “There were 176.6 major congenital malformations (MCMs) per 10,000 infants exposed to first-trimester COVID-19 mRNA vaccines, compared with 179.4 per 10,000 infants not exposed to the vaccines.
    • “There were no associations between mRNA vaccine exposure and MCMs by organ system.
    • “There was no difference in the rate of stillbirths between pregnant women who received mRNA vaccines and those who didn’t (both 0.4%).”
  • Per BioPharma Dive,
    • “A regimen pairing Johnson & Johnson’s dual-pronged multiple myeloma drug Tecvayli with an older medication, Darzalex, staved off disease progression and death better than Darzalex and a standard drug combination in a Phase 3 trial, the company said Thursday.
    • “According to J&J, a panel of independent trial monitors recommended halting the study early after the Tecvayli regimen met its objectives at an early data check. Researchers have been following trial volunteers for an average of about three years.
    • “The trial assessed the Tecvayli combination in people whose multiple myeloma had progressed after one to three prior treatment lines. Tecvayli is currently available to patients who’ve previously received at least four lines of care. That clearance, awarded in 2022, was an “accelerated” approval, which requires confirmation from a trial that demonstrates a survival benefit.”
  • and
    • “Final results from a years-long study show that Novartis’ Fabhalta medicine can significantly slow the decline of kidney function in patients with IgA nephropathy, the Swiss drugmaker said Thursday.
    • “The trial, known as Applause-IgAN, compared twice-daily doses of Fabhalta with a placebo in patients with the rare kidney disease. After two years of treatment, researchers found that the patients on Fabhalta had significantly better results on a scale that measures how well kidneys filter waste from the blood.
    • “Fabhalta had already won accelerated approval from the Food and Drug Administration in 2024 based on initial data showing the drug could reduce protein in the urine of patients with the condition. With the final study results in hand, Novartis now plans to seek a full, traditional approval of the medicine for IgAN patients next year.”
  • and
    • “In March 2023, investors could buy a share of Praxis Precision Medicines for about the same price as a dollar-menu item at a fast-food restaurant. The Boston-based biotechnology company had just suffered a major setback with one of its experimental medicines, which failed a key study testing it as a treatment for a neurological disease that causes involuntary shaking.
    • “Praxis, as drug companies often do, found enough silver linings in the data to push its medicine forward. The company consulted with the Food and Drug Administration that summer and began enrolling two late-stage trials that fall. By February 2025, a group of independent experts were telling Praxis the first of those trials looked unlikely to succeed. It decided to continue anyway.
    • “That confidence appears to have paid off, as Praxis on Thursday disclosed that both of its studies met their main goals. The company now plans to submit an approval application to the FDA by early 2026. Its share value, which got buffed in late 2023 from a 1:15 stock split, more than tripled on the announcement, peaking at $200 Thursday afternoon.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • ‘New York City-based Montefiore Health System and Garnet Health have signed a letter of intent for Garnet to join the academic health system through a strategic affiliation. 
    • “Garnet Health, a three-hospital system headquartered in Middletown, N.Y., serves more than 500,000 residents across New York’s mid-Hudson and Catskills regions.
    • “The proposed transaction would expand Montefiore’s presence in the Hudson Valley and strengthen Garnet Health’s clinical services, specialty care offerings and long-term sustainability.
    • “Montefiore, which operates 10 hospitals and more than 200 outpatient sites, described the deal as a natural fit.”
  • and
    •  “Already-strained emergency departments are not only projected to experience more volume in the near future, but also more clinical cases requiring immediate attention, according to a Vizient Sg2 report published Oct. 15.
    • “Vizient, which works with hundreds of U.S. hospitals and other healthcare providers, estimates a 5% increase in ED visits between 2025 and 2035. Urgent visits are projected to remain stagnant while emergent cases — those requiring immediate action — are expected to rise 8% over the decade. 
    • “Over the past year, emergent visits increased 6% while urgent visits stabilized. Sixty-five percent of ED visits between the third quarter of 2024 and the second quarter of 2025 were emergent. 
    • “While urgent visits have stabilized, continued efforts to redirect low-acuity patients to alternative care sites remain essential to improving ED throughput and preserving capacity for higher-acuity cases,” the report said.”
  • and
    • “Physician compensation rose more in 2025 than in any year over the past decade, largely due to clinician supply and demand imbalances, according to a survey from SullivanCotter. 
    • “Published Oct. 15, the survey is based on data from more than 500 healthcare organizations representing approximately 231,300 physicians across 232 specialties. It found that median physician total cash compensation — base salary plus incentives — grew year over year across all major specialty categories.
    • “Among those, adult medical specialties saw the largest year-over-year increase at 7.5%, as physician workforce expectations continue to evolve.”
  • Modern Healthcare discusses why private equity wants in on outpatient cardiology.
    • “Private equity investors are training their attention on cardiology — a fast-growing specialty rife with financial opportunity. 
    • “Investor interest in outpatient cardiology practices has grown in recent years, driven by a fragmented market landscape facing financial pressures and an aging population of patients and providers. The Centers for Medicare and Medicaid Services also is reimbursing more cardiac procedures in ambulatory settings, which has been an impetus for private equity firms to make investments.
    • “The growing number of transactions and operational changes hasn’t quieted skepticism about whether the investments are a win for patients. There is limited post-acquisition data on quality, patient volumes and costs of care at individual cardiology practices. The data on private equity’s overall impact on the industry paints a bleak picture.
    • “Private equity is here in cardiology. It’s not going to go away,” said Dr. Samuel Jones, director of inpatient electrophysiology at the Chattanooga Heart Institute and member of the American College of Cardiology’s Board of Trustees.”
  • Healthcare Dive points out,
    • “Prospect Medical Holdings has tentative deals to sell two of its shuttered hospitals in Pennsylvania — Chester Medical Center and Springfield Hospital — for a combined $13 million, according to documents filed to bankruptcy court last week. 
    • “Chariot Allaire Partners has offered $10 million for Crozer-Chester Medical Center, while Restorative Health Foundation and Syan Investments together have offered $3 million for Springfield Hospital.
    • “Closing the deals would allow Prospect to finally rid its hands of failed Crozer Health, following years of conflict with state regulators over its management practices and failed sales attempts. Crozer fully shuttered this spring.”

From the artificial intelligence front,

  • Healthcare Dive lets us know,
    • “Google Cloud revealed several artificial intelligence partnerships with healthcare organizations on Thursday, including for projects that summarize clinical notes and automate prior authorizations. 
    • “The partnerships come as more healthcare and life science firms are deploying AI agents, or advanced tools that can more autonomously plan and perform tasks, according to a Google Cloud survey of 605 leaders released Thursday. Forty-four percent of executives said their organizations were actively using agents, with 34% reporting they use 10 or more agents.
    • “For example, Hackensack Meridian Health built multiple AI agents using Google’s generative AI technology, including a tool that can recap patients’ medical records for doctors.
    • “The health system’s note summarization agent has helped more than 1,200 clinicians generate more than 17,000 summaries since it went live in June, according to a press release.”
  • and
    • “Microsoft is expanding its artificial intelligence-backed clinical assistant to include functionality geared towards nurses, the technology giant said Thursday. 
    • “Dragon Copilot, Microsoft’s upgraded AI assistant tool launched this spring, will be able to record nurses’ interactions with patients and help document their care, as well as access medical content or health system protocols, the company said.
    • “Microsoft collaborated with multiple health systems to build the update focused on nurses’ documentation workflow. “Physicians document very differently,” said Mary Varghese Presti, corporate vice president and chief operating officer at Microsoft Health and Life Sciences. “What we built here for nurses is not a rinse and repeat of that.” 

Tuesday’s report

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Obesity, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Senate returned to Capitol Hill today and is scheduled to hold its eighth vote on the House-passed continuing resolution but is expected to fall short of the 60 votes required to pass the CR. Formal negotiations toward a deal still have yet to take place. The House, which has been out of session since passing the CR Sept. 19, remains out this week with no plans to return.”
  • The FEHBlog adds that today’s Senate eighth vote on the House passed continuing resolution did fall short of the 60 votes required to pass the CR. The vote was 49 ayes and 45 nays. The Majority Leader switched his vote from aye to nay to preserve his ability to bring this cloture motion back to the floor.
  • CNBC informs us,
    • “The government shutdown will delay a key announcement that affects millions of Social Security beneficiaries — just how much their benefit checks will increase in 2026.
    • “The Social Security cost-of-living adjustment for next year will be revealed once September consumer price index data, which was slated for release on Oct. 15, is available. Due to the federal government shutdown, the CPI release has been pushed to Oct. 24.
    • “The Social Security Administration (SSA) will use this release to generate and announce the 2026 cost-of-living adjustment (COLA) on October 24 as well,” a Social Security spokesperson told CNBC.com via email.” * * *
    • “Experts estimate the benefit increase may fall in the range of 2.7% to 2.8%, based on the most recent government inflation data. Such an increase would push the average retirement benefit up by about $54 per month.”
  • Fierce Healthcare relates,
    • “The Purchaser Business Group on Health is launching a massive data project that aims to make it easier for employers to get their arms around what they’re actually paying for healthcare.
    • “The organization unveiled its Health Care Data Demonstration Project on Tuesday morning, which is built on both hospital price transparency data and transparency in coverage information, establishing tools that employers can use to more accurately determine a “fair price” for healthcare services.
    • “The demonstration leans on five large employers, including aerospace company Boeing and technology firm Qualcomm, PBGH said in an announcement. Armed with more accurate pricing data, employers can see where their health plans or third-party administrators may be falling short in managing costs.”
  • WTW identifies ten “surprising expenses” that can be reimbursed from an employee’s health savings account.
  • Life Health Advisor lets us know,
    • “Equitable, a leading financial services organization and principal franchise of Equitable Holdings, Inc. (NYSE: EQH), has announced new findings from a national survey of more than 1,000 consumers, highlighting key financial trends shaping how Americans engage with their workplace benefits.
    • “The survey revealed that 80% of Americans worry that an unexpected medical expense could derail their financial goals, with more than a quarter of this group indicating that a bill under $1,000 would cause financial hardship. Younger generations are especially anxious — 89% of Gen Z and millennials said an unplanned medical cost would disrupt their financial plans, compared to just 56% of baby boomers.
    • “Since employer-sponsored health insurance often does not cover the full cost of medical care, workers frequently pay out of pocket for uncovered expenses. When respondents were asked how they would pay for a costly and unplanned medical bill, 48% said they would set up a payment plan, 31% would use general savings, and 28% would rely on credit cards. Notably, 12% would take a hardship withdrawal from their retirement account, with millennials (20%) and Gen Z (16%) more likely to do so than Gen X (6%) or baby boomers (3%).
    • “Americans’ health and wealth needs are inextricably connected. An unplanned visit to the hospital can put a person’s long-term financial security at risk — especially if they need to tap into retirement savings to cover a costly medical bill,” explained Stephanie Shields, Head of Equitable’s Employee Benefits business. “While some approach open enrollment as a chore each year, it is important to take the time to understand all the benefit options offered by your employer. This investment can protect your health and your financial well-being.”
  • Per a PCMA news release,
    • “After more than seven years leading the Pharmaceutical Care Management Association (PCMA) and in the last year of his contract with the organization, PCMA President and CEO Juan Carlos “JC” Scott today announced his decision to step down before the end of the year.
    • “JC has led PCMA during a critical period of transition in health care. He works tirelessly to advocate for the PBM industry and our mission to lower prescription costs for the patients, businesses, labor unions, health plans, and public partners we’re proud to serve,” said PCMA board chairman Adam Kautzner, PharmD, President, Evernorth Care Management & Express Scripts. “We value JC’s role in leading PCMA to where it is today during a time of dynamic changes on Capitol Hill and in the states. As we begin the search for a new head of the association, it is helpful to have JC’s continued guidance in this transition period.”

From the Food and Drug Administration front,

  • Cardiovascular Business points out,
    • “Medtronic has received an important update from the U.S. Food and Drug Administration (FDA) to the labeling of its Endurant stent graft system.
    • “Going forward, the FDA is allowing Medtronic to include clinical evidence related to the treatment of ruptured abdominal aortic aneurysm (rAAA) in the device’s labeling. In addition, Medtronic can now remove the rAAA treatment warning currently required to be included in the instructions for use (IFU) of the Endurant system and other similar devices.
    • ‘The Endurant stent graft system has been used to treat abdominal aortic aneurysms for more than a decade now. It now stands as the first and only endovascular aneurysm repair (EVAR) system to receive this labeling update from the FDA.” 
  • CNN reports,
    • “The US Food and Drug Administration has given clearance to another blood test to help assess Alzheimer’s disease and other causes of cognitive decline, providing a broader understanding of when the disease can be ruled out.
    • “Roche Diagnostics said Monday that its Elecsys pTau181 test, developed in collaboration with Eli Lilly, could be used by primary care physicians to help identify patients who are unlikely to have Alzheimer’s disease, while those with a positive result would be recommended for further testing.
    • “The test is intended for adults 55 and older in the United States who are showing signs or symptoms of cognitive decline.”
  • Per Fierce Pharma,
    • “It appears problems at Novo Nordisk’s recently acquired manufacturing facility in Indiana aren’t going to be solved any time soon. The FDA has tagged the former Catalent facility with an official action indicated (OAI) label, which is the most severe of the three inspection classifications issued by the agency.
    • “The OAI designation—which identifies facilities that are at “an unacceptable state of compliance,” according to the regulator—is bad news for drugmakers who depend on the massive plant in Bloomington for contract manufacturing.
    • “One of those companies is Scholar Rock, which is bidding for FDA approval of its highly anticipated spinal muscular atrophy (SMA) treatment apitegromab. Another is Regeneron, which has two FDA applications pending for eye disease treatment Eylea, which is produced at the site.
    • “In an email, Novo Nordisk acknowledged receiving the OAI status notification on Oct. 9 and said it is in contact with the FDA and its CDMO partners who are affected.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “More children are getting diagnosed with autism than ever before.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. has promised to find out why. The Trump administration has already touted the active ingredient in Tylenol, acetaminophen, as a possible cause, even as doctors and researchers say the link is unproven.
    • “Autism has a strong genetic component, scientists say, and some known risk factors such as older parental age might have contributed to the increase. Some think environmental exposures that haven’t yet been identified could also have played a role. 
    • “But to explain the bulk of the rise — from one in 150 8-year-old children in 2000 to one in 31 in 2022 — many doctors and scientists point to how the diagnosis itself has morphed over time.” * * *
    • “Some researchers and advocates have started using the term “profound” autism to describe cases among children with an IQ of less than 50 or who are minimally verbal or nonverbal. Around 27% of 8-year-olds with autism in the U.S. fit that description, according to the most recent estimates. 
    • “Profound autism cases have ticked upward, but the much bigger rise has been in the children with fewer impairments. Kids referred for an autism evaluation are now less likely to have intellectual disabilities or major language delays, said Amy Esler, a psychologist and professor in the pediatrics department at the University of Minnesota.” * * *
    • “Clinicians also started screening more kids, after the American Academy of Pediatrics recommended it for all children at 18 and 24 months starting in 2007, researchers said.  
    • Rates vary based on location, with federal data from 2022 showing prevalence ranging from 9.7 per 1,000 8-year-olds in Laredo, Texas, to 53.1 per 1,000 in California.”
  • Health Day tells us,
    • “Heart rate variability biofeedback (HRVB) can reduce negative affect, craving, and substance use among individuals in early recovery from substance use disorder (SUD), according to a study published online Oct. 1 in JAMA Psychiatry.
    • “David Eddie, Ph.D., from Massachusetts General Hospital in Boston, and colleagues examined the efficacy of HRVB in the treatment of SUD. The analysis included 115 adults seeking treatment for SUD who were randomly assigned to receive treatment as usual with or without HRVB as a wearable smart patch.”
  • Cigna, writing in LinkedIn, discusses understanding subclinical mental health conditions and their impact on the workplace.
    • “Subclinical mental health conditions like mental load, daily stressors, and mild anxiety are real challenges for today’s workforce. Though less visible than clinical diagnoses, their impact on productivity, morale, and workplace culture is profound. Recent U.S. data shows these issues are common, making it essential for employers to take notice.
    • “By prioritizing mental health before problems become severe, business leaders and HR managers can create healthier, more engaged teams and a more successful organization. The steps are simple but powerful: open communication, flexibility, education, and access to support. Investing in employee well-being isn’t just about compassion; it’s about building a thriving workplace for everyone.”
  • Gastroenterology Advisor notes,
    • “Patients with ulcerative colitis (UC) and Crohn disease (CD) do not have a higher risk for colonic perforation during colonoscopy than patients without inflammatory bowel diseases (IBDs), according to study results published in Digestive Diseases and Sciences.”
  • The American Journal of Managed Care relates,
    • “A 12-year study in China finds that individuals who dine out often face a higher risk of colon and rectal cancers, with obesity playing a mediating role.
    • “Regularly eating meals away from home may carry more than just financial costs. A large cohort study of over 42,000 adults in China found that frequent dining out was significantly associated with an increased risk of colorectal cancer.1The findings suggest a dose-response relationship, with obesity emerging as a key factor that may partially mediate the link between dining habits and cancer risk.
    • “This cohort study is published in Frontiers in Oncology.
    • “Our findings indicated that over half of the Chinese adult population reported dining out at least once per week,” wrote the researchers of the study. “Furthermore, a significant association was observed between frequent dining out and an elevated risk of both colon and rectal cancers when compared to individuals who dined out rarely or never.” * * *
    • “The study found a 2.23-fold increased risk for colon cancer and a 1.79-fold increased risk for rectal cancer among frequent diners.”
    • “Obesity partially mediates the association between dining out frequency and colorectal cancer risk.”
    • “Limitations include self-reported dining frequency, potential unmeasured confounders, and lack of detailed meal data.”
  • Per a UNC Health news release,
    • “A first-of-its-kind clinical study shows that offering modest monthly grocery cards for produce leads to improvements in blood pressure compared to distributing pre-selected boxes of healthy food.
    • “While the link between nutrition and improved health outcomes is well established, there had previously been limited clinical evidence to guide how best to deliver healthy food to individuals facing food insecurity. Funded by Blue Cross and Blue Shield of North Carolina (Blue Cross NC) and conducted by researchers at UNC Health and UNC Schools of Medicine and Public Health, the Healthy Food First trial offers compelling evidence that empowering people to choose the nutritious foods they want can drive meaningful improvements in health outcomes, helping more North Carolina families take steps toward healthier lifestyles.
    • “High blood pressure affects about half of all adults and can lead to serious heart problems. Even though many people get treatment, UNC researchers say more than 75% of Americans with high blood pressure still have readings that are too high, and food insecurity can cause those numbers to go up.”
  • Per Fierce Pharma,
    • “Pfizer’s oncology portfolio has produced a second positive phase 3 trial in HER2-positive breast cancer in the span of about a year.
    • “This time, the drug that delivered the positive readout is Tukysa, a HER2-targeted tyrosine kinase inhibitor that Pfizer picked up in its $43 billion acquisition of Seagen.
    • “When used as a first-line maintenance therapy in patients with HER2-positive metastatic breast cancer who’ve responded to standard induction therapy, Tukysa significantly prolonged the time before cancer progression or death compared with placebo, Pfizer said Tuesday. Both Tukysa and placebo were given in combination with the standard maintenance regimen of Roche’s Herceptin and Perjeta.
    • “The statistically significant and clinically meaningful improvement in progression-free survival means that the phase 3 HER2CLIMB-05 trial has met its primary endpoint, Pfizer said.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are grappling with a shortage of anesthetists and reimbursement cuts, a combination of factors that could limit patient’s access to care and provider’s expansion plans. 
    • “They hope to stave off service reductions by training more CRNAs and simplifying clinician operations, but those strategies may not overcome mounting financial pressures, hospital executives and staffing experts said. Rural areas could be particularly hard hit.
    • “There is serious financial strain on the cost to keep surgery departments going right now,” said Alex Herbison, vice president of physician solutions at staffing firm AMN. “It doesn’t feel sustainable.”
  • Beckers Hospital Review informs us,
    • “CVS Health released its 2025 “Rx Report: Community Pharmacy Reimagined” Oct. 14, highlighting trends in patient expectations, workforce dynamics and technology adoption across the pharmacy sector.
    • “To devise the report, CVS surveyed more than 2,200 customers and 1,060 pharmacists and pharmacy technicians.”
    • The article offers seven takeaways from the CVS report.
  • Beckers Oncology identifies 50 “hospitals and health systems that are opening cancer centers or expanding cancer care services in 2025.”
  • Healthcare Dive reports,
    • “California Gov. Gavin Newsom signed into law new rules on Monday that will place more restrictions on corporate investors’, including private equity firms’, role in healthcare delivery.
    • “The law, Senate Bill 351, prohibits financial firms from having a hand in medical decisions, including determining how many patients clinicians see per hour or what diagnostic tests are appropriate. 
    • “The legislation was drawn up in response to a growing body of evidence that links private equity firms’ involvement in healthcare to higher costs, lower care quality and reduced services, according to the California Medical Association, which backed the bill.” 
  • The Wall Street Journal relates,
    • “Johnson & Johnson plans to separate its artificial hip and knee business into a stand-alone company to be called DePuy Synthes.
    • “J&J said it expects to complete the separation within 18 to 24 months.
    • “This separation is part of J&J’s strategy to focus on higher-growth and higher-margin businesses.”
  • Per BioPharma Dive,
    • “Obesity startup Kailera Therapeutics has raised one of the year’s largest private funding rounds, securing $600 million to support global, late-stage testing of an injectable drug that works similarly to Eli Lilly’s Zepbound.
    • “Bain Capital Private Equity led the Series B round, which also involved Adage Capital Management, investment funds from the Canadian and Qatari governments, Royalty Pharma and other investors. Multiple so-called crossover investors that back private and public drug companies participated, too. 
    • “Kailera and its partner Hengrui Pharma reported in July that the drug, called KAI-9531 or HRS9531, helped people with obesity lose 18% of their body weight on average in a 48-week Phase 3 trial in China, positioning the company to seek approval there. The Food and Drug Administration will likely require a larger, longer, multi-country study before considering a U.S. clearance.”
  • Per Fierce Healthcare,
    • “Oura, the company behind the personal health tracker the Oura Ring, has raised more than $900 million in series E funding, reflecting the company’s rocketing revenue and sales over the last year. 
    • “The company is now worth $11 billion. 
    • “In 2025, Oura Rings soared in sales. The preventive health company has sold 5.5 million smart rings since 2015, and nearly 3 million of those sales occurred in 2025. Its total sales for the year are expected to reach $1 billion between the devices and app subscriptions, according to the company.
    • “The Oura Ring and corresponding app track health metrics like sleep, fertility windows, heart rate, activity and movement and metabolic health.” 
  • and
    • “Digital health platform Hello Heart is launching a new suite of medication management tools for people at risk of heart disease, including an AI assistant for heart health.
    • “Through a connected blood pressure monitor and app, patients can track their blood pressure, cholesterol and medications. Hello Heart aims to reduce the cost of cardiovascular conditions, which, if left untreated, result in costly hospitalizations. Nearly half of the U.S. adult population has hypertension.
    • “The new suite of tools aims to help patients take their medications and manage side effects. It has three components: Nia, an AI assistant; a connected pill box; and chart reviews of high-risk members’ health records by pharmacists.
    • “Medication is the best way to treat high blood pressure, a major risk factor for heart conditions, Edo Paz, M.D., senior vice president of medical affairs at Hello Heart, said in an interview. However, many patients struggle to remember to take their medication or discontinue medications because they don’t perceive a benefit.”
  • Per Fierce BioTech,
    • “Having already established a commercial infrastructure for its oral hereditary angioedema (HAE) drug Orladeyo and eager to pinpoint the source of its future growth, BioCryst Pharmaceuticals has struck a $700 million deal to buy Astria Therapeutics. 
    • “The deal will give the rare disease specialist control of a phase 3 challenger to Takeda’s HAE therapy Takhzyro.
    • “North Carolina-based BioCryst already sells the daily oral capsule Orladeyo, which won approval in 2020 to prevent HAE attacks in patients 12 and older. Forecasting that Orladeyo sales will peak at $1 billion around the end of the decade, the company has been investing in drug discovery and scouting around for deals to drive its next phase of growth.”
  • Per MedTech Dive,
    • Medtronic said Wednesday [October 9] it has completed the first procedures in a U.S. clinical study assessing the safety and effectiveness of its Hugo robot in gynecological procedures.
    • Gynecology is the focus of Medtronic’s third investigational device exemption study in the U.S., after trials for urology and hernia repair met their primary safety and effectiveness endpoints.
    • The total hysterectomy procedures were performed at AHN West Penn Hospital in Pittsburgh. Medtronic expects to enroll as many as 70 people across up to five U.S. hospitals, and include patients having radical, modified radical or total hysterectomies, as well as those being treated for malignancies.

Midweek update

David Ermer–CDC, CMS, FDA, Medical / Rx research, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Federal News Network tells us,
    • “Despite being less than a week away from the government’s funding deadline, and with lawmakers still far from reaching a spending agreement, agencies have not published their plans for what would happen during a government shutdown.
    • “Often, leading up to a possible government shutdown, agencies will publish or update their shutdown contingency plans, which are made publicly available on the Office of Management and Budget’s website. Those plans typically detail how many federal employees at each agency would continue to work — and how many would be furloughed — if a shutdown were to happen.
    • “But even with the fast-approaching deadline for Congress to reach a spending agreement for fiscal 2026 appropriations, OMB’s webpage that usually hosts that contingency information is completely blank.
    • “OMB did not respond to multiple requests for comment from Federal News Network, asking if the Trump administration intends to publish agencies’ contingency plans, or if there were any alternative government shutdown planning efforts currently in the works.”
  • Politico adds
    • “The White House budget office is instructing federal agencies to prepare reduction-in-force plans for mass firings during a possible government shutdown, specifically targeting employees who work for programs that are not legally required to continue.
    • “The Office of Management and Budget move to permanently reduce the government workforce if there is a shutdown, outlined in a memo shared with POLITICO ahead of release to agencies tonight, escalates the stakes of a potential shutdown next week.
    • “In the memo, OMB told agencies to identify programs, projects and activities where discretionary funding will lapse on Oct. 1 and no alternative funding source is available. For those areas, OMB directed agencies to begin drafting RIF plans that would go beyond standard furloughs, permanently eliminating jobs in programs not consistent with President Donald Trump’s priorities in the event of a shutdown.
    • ‘The move marks a significant break from how shutdowns have been handled in recent decades, when most furloughs were temporary and employees were brought back once Congress voted to reopen government and funding was restored. This time, OMB Director Russ Vought is using the threat of permanent job cuts as leverage, upping the ante in the standoff with Democrats in Congress over government spending.”
  • Axios reports,
    • “Big drug companies so far are responding to President Trump’s demand they commit to his “most favored nation” pricing policy by raising prices abroad without cutting them in the U.S.
    • “That only gets halfway toward Trump’s goal of ending what he calls “global freeloading” and getting other developed countries to foot more of the cost while lowering costs for Americans.” * * *
    • “The pharmaceutical industry says it agrees with the goal of making other countries pay more and putting an end to “foreign freeloading.” But drastically cutting U.S. prices to match those abroad would hurt innovation, officials argue. 
      • “Industry is more receptive to other Trump ideas like offering sales directly to patients who pay on their own without insurance. 
      • “We must reject foreign price control models that ration care and suppress innovation,” PhRMA CEO Steve Ubl wrote in an op-ed in Stat in June. 
      • “If we instead required hospitals and [pharmacy benefit managers] to pass along the steep discounts they already receive — and ensured wealthy nations paid their fair share — U.S. prices could fall without jeopardizing our life sciences edge.”
  • Per an HHS press release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced it has awarded more than $45 million in new supplemental funding to State Opioid Response (SOR) program recipients to focus on sober or recovery housing among young adults. This investment advances President Trump’s Executive Order, Ending Crime and Disorder on America’s Streets, by providing sober housing and recovery support services, which are critical to combatting our Nation’s challenge of homelessness, addiction, and illness.
    • “President Trump has elevated this issue as a key public health and public safety priority,” said HHS Secretary Robert F. Kennedy, Jr. “All too often, young adults with opioid or stimulant use disorders lack safe housing to support their recovery. This funding can make a life-changing difference for young people working toward long-term recovery.”
    • “Firsthand experience has shown me that wraparound services, especially sober housing, play a vital role in breaking the cycle of addiction,” said SAMHSA Principal Deputy Assistant Secretary Dr. Art Kleinschmidt. “This supplemental funding will help expand that lifesaving care and help people pursue a fulfilling life in recovery.”
    • “Sober housing for those in early recovery is a safe and supportive alcohol- and drug-free residence where people can live, build stability and work toward independence. This therapeutic model allows people to actualize their hopes and dreams to live a fulfilling and self-directed life.”

From the Food and Drug Administration front,

  • Per MedTech Dive,
    • “Olympus told customers last week to stop using certain lots of its ViziShot 2 FLEX (19G) needles due to the risk that components may detach during procedures. 
    • “Olympus started the recall after receiving reports of patient injuries and one death. Olympus did not immediately respond to a request for comment or specify how many injury reports it had received.
    • “The medtech company has faced quality concerns in recent years, with the Food and Drug Administration sending multiple warning letters to Olympus in 2023 related to its endoscopes, and blocking some of the devices from entering the U.S. in June.”
  • and
    • “Johnson & Johnson has recalled certain automated controllers for its Impella heart pumps over a fault linked to five serious injuries, the Food and Drug Administration said Tuesday.
    • “The company’s Abiomed unit told customers to return the affected devices when contacted by its field servicing team because of potentially fatal purge pressure issues. Abiomed will make a design change during device servicing to correct the problem. Hospital inventory can continue to be used, according to the FDA’s alert.
    • “J&J’s recall, which triggered an FDA early alert, follows other recent safety actions to address two problems with Impella that were collectively linked to four deaths.”

From the judicial front,

  • Bloomberg Law reports,
    • “The full Fifth Circuit confronted the limits of agency rulemaking in arguments over a Biden administration rule for a surprise medical billing law.
    • “The en banc appellate court in New Orleans heard an appeal Wednesday on whether federal agencies exceeded their authorities in a rule on the calculation of a key figure under the No Surprises Act. That law is meant to protect patients from excessive medical bills.
    • “The billing law mandates that medical providers and health insurers settle out-of-network disputes through arbitration. The measure is aimed at protecting patients from medical bills stemming from out-of-network emergency care and from out-of-network clinicians’ care received at in-network facilities.
    • “Justice Department attorney Kevin Soter told the appellate court’s 17 active judges that the statute left it up to federal agencies—the Department of Labor, the Department of Health and Human Services, and the Office of Personnel Management—to come up with details on the arbitration process for surprise medical bill disputes.
    • “Judges Leslie Southwick and Catharina Haynes asked about impact of the US Supreme Court’s 2024 ruling in Loper Bright Enterprises v. Raimondo, which eliminated deference to agencies in interpreting vague laws. Soter said that through the statute, “Congress did clearly put this in the hands of the departments.” * * *
    • “The case is Texas Medical Association v. HHS, 5th Cir. en banc, No. 23-40605, oral argument 9/24/25.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “In its weekly measles update, the Centers for Disease Control and Prevention (CDC) said there are now 1,514 confirmed measles cases in the United States reported this year, with 23 new cases reported in the past week. 
    • “Eighty-six percent of the cases have been part of 40 outbreaks reported to the CDC. Of note, 92% of case-patients are unvaccinated or have unknown vaccination status, 4% have only one measles, mumps, and rubella dose, and 4% were fully vaccinated. 
    • “Twelve percent of cases have required hospitalization, with 29% of those hospitalized aged 19 years or younger. There have been 3 confirmed measles deaths this year.” 
  • The Centers for Disease Control and Prevention announced,
    • “A new report from the Centers for Disease Control and Prevention (CDC), published in the Annals of Internal Medicine, highlights a dramatic increase in a dangerous type of drug-resistant bacteria called NDM-producing carbapenem-resistant Enterobacterales (NDM-CRE). 
    • “In a 2022 special report, COVID-19: U.S. Impact on Antimicrobial Resistance, CDC noted that in 2020 there were approximately 12,700 infections and 1,100 deaths in the U.S. due to CRE. The rise in NDM-CRE, documented in the new study, threatens to increase CRE infections and deaths.
    • “Between 2019 and 2023, NDM-CRE infections surged by more than 460% in the United States. These infections —including pneumonia, bloodstream infections, urinary tract infections, and wound infections—are extremely hard to treat and can be deadly. Detection is also challenging, as many clinical laboratories lack the necessary testing capacity.
    • “This sharp rise in NDM-CRE means we face a growing threat that limits our ability to treat some of the most serious bacterial infections,” said Danielle Rankin, an epidemiologist in CDC’s Division of Healthcare Quality Promotion. “Selecting the right treatment has never been more complicated, so it is vitally important that healthcare providers have access to testing to help them select the proper targeted therapies.”
  • Per MedPage Today,
    • “Sexually transmitted disease (STD) rates for U.S. adults fell last year, but syphilis in newborns continued to rise, according to new government data posted Wednesday.
    • “The CDC provisional data for 2024 showed a third consecutive year of fewer gonorrhea cases, and the second year in a row of fewer adult cases of chlamydia and the most infectious forms of syphilis.
    • “But congenital syphilis cases, in which infected moms pass the disease to their babies, aren’t seeing the same improvements. Such infections in infants can lead to deaths or lifelong health problems such as deafness, blindness, and malformed bones.”
  • and
    • “Drinking any amount of alcohol increased dementia risk, data from a combined observational and genetic study suggested.
    • “Light alcohol consumption was associated with low dementia risk in observational analyses, and genetic analyses showed a monotonic increasing dementia risk with higher alcohol intake, reported Anya Topiwala, DPhil, of the University of Oxford in England, and co-authors.
    • “Mendelian randomization suggested a causal role of alcohol consumption in increasing dementia risk with no evidence supporting a protective effect at any consumption level, Topiwala and colleagues wrote in BMJ Evidence-Based Medicine.”
  • BioPharma Dive informs us,
    • “UniQure said Wednesday it will ask the Food and Drug Administration next year to approve its gene therapy for the neurodegenerative disorder Huntington’s disease following positive data from a Phase 2 study that showed it slowed signs of disease progression by 75% after three years.
    • “Though from only 12 patients who’d received the highest tested dose of the therapy, AMT-130, and had been evaluated for at least 36 months, the effects were “greater than what we even anticipated and expected and hoped for,” said Sarah Tabrizi, director of the University College London Huntington’s Disease Center, on a conference call.”
  • and
    • “Acadia Pharmaceuticals is giving up on a drug to treat the insatiable hunger associated with Prader-Willi syndrome after a Phase 3 trial failed to prove the experimental medicine was more effective than a placebo.
    • “The 12-week study tested the effects of ACP-101 in 175 patients with the rare genetic syndrome. The main goal was improvement on a questionnaire measuring the hunger, known as hyperphagia. But the drug didn’t show advantages over a placebo on that primary endpoint or any secondary endpoint, Acadia said Wednesday.”
  • MedPage Today notes,
    • “Supplementing digital breast tomosynthesis (DBT) with molecular breast imaging (MBI) increased the detection of cancers in women with dense breasts, a prospective study suggested.
    • “In an analysis involving nearly 3,000 women with dense breasts, adding MBI to DBT led to incremental cancer detection rates of 6.7 and 3.5 cancers per 1,000 screenings in year 1 and year 2, respectively (both P<0.001), reported Carrie B. Hruska, PhD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.
    • “Supplemental MBI also increased invasive cancer detection by more than 2.5 times that of DBT alone at both screening rounds, they noted in Radiology.
    • “Across both screenings, there were 30 cancers detected in 29 women with MBI only. Most of these incremental cancers (71%) were invasive. Additionally, 90% of the cancers detected only with MBI were node negative, “indicating that MBI screening provides early detection,” Hruska and colleagues wrote.”
  • Per Health Day,
    • “Providing immediate bedside hepatitis C virus (HCV) consultation at discharge from labor and delivery for women with HCV-affected pregnancies is associated with higher rates of treatment completion than referral for outpatient follow-up, according to a study published in the October issue of O&G Open.
    • “Leah Madeline McCrary, M.D., from Washington University in St. Louis (WashU), and colleagues evaluated the associations of a traditional postpartum outpatient referral (92 women) compared to an opportunistic inpatient consultation (33 women) for HCV treatment initiation on HCV treatment completion. 
    • “The researchers found that all individuals in the inpatient referral group had an inpatient consultation; however, a majority (55.4 percent) of those in the outpatient referral group did not present for consultations. Inpatient referral was associated with higher rates of HCV treatment completion (20 of 30) among women who were prescribed direct-acting antivirals compared with standard care (14 of 41). Inpatient treatment was associated with higher odds of treatment completion (adjusted odds ratio, 4.7).”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Premier is going private through an acquisition by healthcare-focused investment firm Patient Square Capital, the companies announced Monday.
    • “The deal values Premier at roughly $2.6 billion and is set to take the company, which provides supply chain, technology and consulting services to thousands of U.S. providers, off the public markets after more than a decade.
    • “Premier and Patient Square expect the deal to close by the first quarter of 2026 subject to regulatory approval and other closing conditions.”
  • and
    • “Privia Health is acquiring a value-based primary care business from Evolent Health as the physician enablement company continues to expand its care delivery network into new geographies.
    • “Evolent has agreed to sell its accountable care organization business, called Evolent Care Partners, for $100 million in cash, the companies announced aftermarket Tuesday. Another $13 million is contingent on the ACO’s performance in traditional Medicare’s largest value-based care program in 2025.
    • “The transaction is expected to close in the fourth quarter and positively contribute to Privia’s adjusted earnings next year. Analysts said the deal is favorable for both parties.”
  • Fierce Healthcare relates,
    • “UnitedHealthcare is rolling out a new offering that aims to make it easier for employer plan members to shop for health and wellness solutions that meet their needs.
    • “The UHC Store is embedded in the insurer’s member portal and app and is now available to 6 million people enrolled in its employer-sponsored health plans. The payer giant plans to expand to 18 million members this year.
    • “Members who access the store are eligible for discounts of up to 15% of health and wellness programs of their choice, according to its announcement. The team initially focused on programs that fit within some of the most in-demand and high-cost areas, such as women’s health, musculoskeletal conditions and diabetes, according to Amy Jordan, vice president of consumer experience for UnitedHealthcare’s commercial business.”
  • and
    • “Harbor Health continues to expand its clinical footprint in Texas with the acquisition of 32 clinics from VillageMD.
    • ‘The deal expands the company’s reach into three new markets: San Antonio, El Paso and Dallas. Harbor Health also grew its established clinical footprint in its home base of Austin. Financial terms of the deal were not disclosed.
    • “The acquisition nearly quadrupled Harbor Health’s clinical presence, growing from 11 to 43 total clinics and adding more than 80 clinicians to its team of physicians and advanced practice providers. The acquisition also advances the company’s philosophy that having a denser network of clinics improves quality of care through enhanced accessibility.” 
  • Fierce Pharma informs us,
    • “Excitement around Fujifilm Biotechnologies’ massive new cell culture facility in Holly Springs, North Carolina, has been growing steadily since 2021, prompting a beefed-up investment from the company last April and a string of high-profile manufacturing contracts this year.
    • “Now, some four years since the project’s reveal, Fujifilm Biotechnologies is opening the doors to the facility, which might look familiar to anyone who’s worked with the CDMO in Denmark.
    • “The opening of the Holly Springs site, which will focus on antibody-based drugs, marks the debut of one of the largest cell culture biomanufacturing sites in the U.S., Fujifilm Biotechnologies said in a Sept. 24 press release.”
  • and
    • “Jiangsu Hengrui Pharmaceuticals’ dealmaking spree rolls on, with a potential $1.1 billion transaction on a rival to AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu being the latest addition.
    • “Hengrui is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to a subsidiary of India’s Glenmark Pharmaceuticals, the two parties announced (PDF) Wednesday.
    • “The deal is heavily back-loaded, as it features an upfront payment of $18 million and up to $1.09 billion in regulatory and commercial milestones, plus sales-based royalties.”
  • Beckers Payer Issues discusses an Experian Health report about the 2025 State of [Health Plan] Claims.
  • Avalere Health explains how “CMS Continues to Refine Value-Based Care Approach for Kidney Care.”
  • Radiology Business reports,
    • “Medical imaging accounts for 4 of the 5 most prevalent low-value healthcare services among Medicare beneficiaries, according to new research published Friday. 
    • “Imaging for plantar fasciitis” was the most frequently delivered unnecessary exam, occurring nearly 84 times per 100 Medicare beneficiaries, experts write in JAMA Health Forum. Low-value imaging for headache (76/100), syncope (72/100) and lower back pain (39/100) also made the top five, with vertebroplasty and kyphoplasty at No. 4. 
    • “The findings are based on a review representing claims from over 3.7 million Medicare beneficiaries treated between 2018 and 2020. Altogether, the payment program spent approximately $484 million on 15 different low-value imaging services, a figure that balloons to nearly $584 million when factoring in beneficiaries’ out-of-pocket costs.  
    • “Findings of this cross-sectional study highlight that reforms aimed at reducing spending for low-value services are feasible to achieve billions in savings without compromising patient health,” David D. Kim, PhD, and A. Mark Fendrick, MD, with the universities of Chicago and Michigan, respectively, wrote Aug. 1.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NCQA, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Democrats blocked Republicans’ stopgap measure that would keep the government funded until late November and insisted that major healthcare spending be added to the bill, raising the odds for a partial shutdown in less than two weeks.
    • “Friday’s vote in the Republican-controlled Senate was 44 in favor and 48 against, short of the 60 votes required. Sens. Rand Paul of Kentucky and Lisa Murkowski of Alaska were the only Republicans to vote against the measure, while Democratic Sen. John Fetterman voted in favor. Several Republicans were absent. 
    • “The GOP-led House narrowly passed the measure earlier in the day in a 217-212 vote largely along party lines.
    • “The failure of the bill in the Senate set the stage for a down-to-the-wire standoff, with both parties standing firm and saying the other one would take the blame for a fall shutdown. * * *
    • Democrats proposed an alternative that would fund the government through Oct. 31 and reverse hundreds of billions of dollars in cuts to Medicaid enacted under the Republican tax-and-spending legislation that Republicans have rebranded the “working families tax cut.” The Democratic alternative would permanently extend certain ACA subsidies that expire at the end of this year. * * *
    • Republicans rejected the Democratic proposal as unserious. It failed in its own vote with 47 in favor and 45 opposed, short of the 60-vote requirement. Republicans control the Senate 53-47.
    • “The Democrats want a ransom payment of more than $1 trillion to keep the government open for only four more weeks,” said Senate Majority Whip John Barrasso (R., Wyo.).
    • [Senator Lisa] Murkowski [(R. AK), who voted against both the Republican plan and the Democratic proposal, said she wants a continuing resolution that extends enhanced ACA subsidies for two years, in addition to addressing some fiscal year 2026 appropriations and funding for the public media.
    • “Both of these were messaging bills,” she said. “They both did what everybody predicted was going to happen, which was, they were going to go down.
  • STAT News reports good news from Atlanta,
    • “A government advisory committee voted unanimously Friday to recommend that individuals 6 months and older should discuss the risks and benefits of Covid-19 vaccines with their health care providers before deciding whether to get vaccinated.
    • “The decision, if signed off on by federal health leaders, would preserve insurance coverage for the shots, and is similar to the Food and Drug Administration’s approvals of the updated vaccines earlier this year. The Advisory Committee on Immunization Practices, convened by the Centers for Disease Control and Prevention, emphasized that for people under 65, the benefits of vaccination are most clear for people with risk factors for severe Covid-19.
    • “This vote provides for immunization coverage through all payment mechanisms including entitlement programs such as Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal health insurance marketplace,” a Health and Human Services spokesperson said.”
  • and
    • “A key government advisory committee voted Friday to postpone a vote on whether to delay infants’ first hepatitis B vaccine — temporarily alleviating fears that a new recommendation on shot timing could reverse the significant progress made in controlling the disease’s spread in recent decades.
    • “The decision followed a lengthy deliberation on Thursday by the newly reconstituted Advisory Committee on Immunization Practice, which pressed scientists from the Centers for Disease Control and Prevention on the necessity of the birth dose, and brought into question the veracity of the data presented on the risks and benefits of the vaccine. But ultimately, members voted to push the vote.”
    • “I believe that there’s enough ambiguity here and enough remaining discussion about safety, effectiveness, and timing that I believe that a vote today is premature,” Robert Malone, a member of the committee, said on Friday. All of the members of the committee, except its chair, Martin Kulldorff, voted to table the vote.”
  • Per a Congressional news release.
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a statement on the Advisory Committee on Immunization Practices (ACIP) postponing a vote to change the recommendation for the hepatitis B vaccine for newborns. If a recommendation for a vaccine is altered without a scientific basis, insurance companies may decide to no longer cover it for patients free of charge. Additionally, doctors will lack the necessary information to counsel families, so they make the best health care decisions for their children.
    • “At Wednesday’s hearing, Cassidy underscored the importance of families having access to the hepatitis B vaccine at birth.”
  • Here is an informative Blue Cross link to an article about No Surprises Act abusive practices by providers particularly in the arbitration / IDR process.  In my opinion, which supplements the Blue Cross recommendations, the NSA arbitration process would be more equitable if the Tri-Agencies added more substance from the AAA baseball / final offer rules to its IDR procedures. 
  • Beckers Payer Issues informs us,
    • “CMS has finalized a rule requiring Medicare Advantage plans to submit provider directory data for inclusion in the Medicare Plan Finder. 
    • “The change, aimed at improving transparency and beneficiary decision-making, takes effect January 1, 2026.
    • “Under the rule, MA plans must make provider directory information available to CMS in a standardized format for online publication, update the data within 30 days of becoming aware of changes, and attest at least once a year to the accuracy of the information.
    • “CMS said the move is designed to allow beneficiaries to more easily compare provider networks across plans without having to navigate multiple websites. The agency expects to publish an operational guide in the coming months with technical specifications for plans to follow, along with a testing period before the data appears publicly online.”
  • The American Hospital Association News explains that this CMS rule was part of a larger rulemaking.
    • “The Centers for Medicare & Medicaid Services Sept. 18 released a final rule on policy and technical changes to Medicare Advantage, the Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly for contract year 2026. Yesterday’s final rule follows one released in April on other changes for MA and prescription drug programs. In the latest final rule, CMS finalized a requirement aimed at increasing beneficiary access to provider directory data in the CMS Medicare Plan Finder platform.”
  • The Government Accountability Office released a report titled “Urban Hospitals: Factors Contributing to Selected Hospital Closures and Related Changes in Available Health Care Services.”
    • “About half of U.S. hospitals are in urban areas. More urban hospitals closed than opened from 2019 to 2023.
    • “All of the 5 hospitals in our review struggled financially before they closed, with inpatient volumes decreasing at 4 of them. The anticipated cost of upgrading or maintaining aging facilities also contributed to the closures of all 5 hospitals.
    • “After closure, 2 of the hospitals still provided outpatient services, while the other 3 stopped all services.
    • “Representatives from local hospitals, providers, and community organizations told us some community residents continued having trouble getting health care after all 5 hospitals closed.”
  • Last but not least, OPM Director Scott Kupor released his regular Friday blog post which concerns OPM’s mine in Boyers, PA, that holds paper personnel records.
    • “The Boyers mine is but one of many examples of opportunities for modernization across the federal government. None of these challenges are rocket science – maybe with the exception of our friends at NASA – but they have been plagued for too long by a system that doesn’t demand inventiveness and efficiency as first-class citizens in the government vernacular. OPM aims to create fluency in this new language – and we are starting with one retirement piece of paper at a time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “The cancer medication Keytruda is the world’s best-selling drug. But with lower-priced competition set to arrive as soon as 2028, Keytruda’s manufacturer, Merck, is on the brink of losing tens of billions of dollars in sales.
    • “To keep Keytruda revenue flowing, Merck followed a well-worn playbook. It developed a new version of the drug, given as a shot under the skin, which the Food and Drug Administration approved on Friday.
    • “The company is talking up the new version as quicker and easier for patients than the original therapy, which is given through tubes as an intravenous infusion.
    • “Keytruda is approved to treat 18 types of cancer, including of the skin, lung, breast and colon. It has been given to 2.9 million patients and helped former President Jimmy Carter extend his life by nearly a decade. Since arriving in 2014, Keytruda has generated $146 billion in sales for Merck. The drug accounts for nearly half of Merck’s revenue.”
  • Per MedPage Today,
    • “The FDA approved the Altaviva implantable nerve stimulator for urge urinary incontinence (UUI), a common symptom of overactive bladder (OAB), Medtronic announced.
    • “Inserted near the ankle in a minimally invasive procedure, the device generates low-level electronic impulses that stimulate the tibial nerve to restore bladder-brain communication. The device is the third tibial neuromodulator for UUI, joining the eCOIN device approved in 2022opens in a new tab or window and the Revi System approved in 2023.
    • “The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” Kevin Benson, MD, of Sanford Health in Sioux Falls, South Dakota, said in a statement. “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has published an early alert about risks posed by Abbott’s Tactiflex Ablation Catheter.
    • “Officials published the alert Thursday in response to Abbott writing to customers. The company updated its instructions after reviewing three reports of catheter tips detaching in patients. 
    • “Abbott had not received any reports of serious injuries or deaths as of Sept. 11. However, the potential for harm led the FDA to class the safety action as a potentially high-risk issue.”
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells).
    • “The FDA remains committed to facilitating the development of effective and safe therapies for rare diseases and will continue to work diligently to help ensure patients with rare diseases have access to innovative treatments,” said George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research.
    • Barth syndrome primarily affects males, typically starts with severe heart failure in infancy, and causes premature death. Patients who survive into adolescence and adulthood often have fatigue, poor stamina, and exercise intolerance. The quality of life and daily functioning of patients with Barth syndrome are significantly affected throughout their lives.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in adults 65 years and older. Hospitalization numbers are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is very low nationally.
  • The AHA News points out,
    • “The Department of Health and Human Services Sept. 18 announced it will take new actions to help improve care for individuals with long COVID. They include a public awareness and education campaign; the launch of an online platform for physicians, researchers and health systems to share best practices and clinical insights; and an Agency for Healthcare Research and Quality report also released Sept. 18 that covers the sources of health coverage for adults with long COVID.” 
  • Fierce Pharma lets us know,
    • “The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences’ twice-yearly HIV pre-exposure prophylaxis (PrEP) med Yeztugo, representing a step forward on the road to wider U.S. adoption of the med. Still, work remains to increase access for all who need it, advocacy groups warn. 
    • “The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead’s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA’s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence.
    • “Based on the studies, the CDC “strongly recommends” Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug “has the potential to improve PrEP adherence and thus enhance HIV prevention.”
  • Per Health Day,
    • “Aspirin can cut by more than half the risk that colon cancer will come back following initial treatment, a new clinical trial has found.
    • “Daily aspirin reduced by 55% the risk of cancer recurrence in patients whose colorectal cancer is driven by a genetic mutation, researchers reported Sept. 17 in the New England Journal of Medicine.
    • “Aspirin is a drug that is readily available globally and extremely inexpensive compared to many modern cancer drugs, which is very positive,” lead researcher Anna Martling, a professor of molecular medicine and surgery at Karolinska Institute in Sweden, said in a news release.
    • “The study focused on people whose colon cancer was driven by a mutation of the PIK3 gene, which helps regulate cell growth and division in the human body.
    • “Every year, about 107,320 new cases of colon cancer and 46,950 cases of rectal cancer are diagnosed in the United States, according to the American Cancer Society.”
  • NBC News reports,
    • “Wildfire smoke is responsible for tens of thousands of deaths each year and will do more harm to U.S. residents by midcentury than any other threat driven by climate change, including extreme heat. 
    • “That’s the conclusion of a new research paper that provides some of the most extensive modeling of the growing health toll of wildfire smoke on public health in the U.S. 
    • “The study, which was published in the journal Nature on Thursday, found that each year, on average, wildfire smoke is causing more than 41,400 excess deaths, or more than would be normally expected without smoke given the demographics of the U.S. That figure is more than twice what was previously recognized in other studies. 
    • “By midcentury, the study’s authors expect that number to grow by an additional 26,500 to 30,000 deaths as human-caused climate change worsens and the risk of wildfires igniting increases. 
    • “Wildfire smoke is a much larger health risk than we might have understood previously,” said Marshall Burke, a professor of environmental social sciences at Stanford University and a study author.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are working directly with employers to improve cancer care and lower costs as demand — and employers’ healthcare expenses — surge.
    • “Providers are gearing up to treat more cancer patients, hoping to ease employers’ mounting frustration with steep premium increases, long appointment wait times and unnecessary treatment, health system and care navigation company executives said. Cutting out insurers through direct contracts could add transparency to employers’ healthcare costs and help standardize treatment strategies, they said.
    • “Employers and unions have no choice but to take a really hard look at solutions that are going to steer patients to high-quality and lower-cost care,” said Emily Kauff, executive director of Memorial Sloan Kettering Cancer Center’s MSK Direct. “Employers are in crisis — they need lower costs and better value in cancer care.”
  • Beckers Payer Issues adds,
    • “Patients who get primary care from older adult-focused, value-based care organizations are more likely to use these services regularly, according to a study published in NEJM Catalyst: Innovations in Care Delivery, a digital journal published by The New England Journal of Medicine. 
    • “The study, produced by Humana Healthcare Research and Suhas Gondi, MD, attending physician at Boston-based Massachusetts General Hospital, covered 3.2 million Medicare Advantage members and included six older adult-focused facilities, most full-risk practices, according to Humana Chief Medical Officer Kate Goodrich, MD. The team found value-based care — as opposed to physicians offering a greater volume of services — is linked to increased use of primary care services.
    • “The exciting thing about this paper is that it shows that in those higher or more mature types of practices that are focused on seniors, they’re getting more primary care, and they’re getting more consistent primary care,” Dr. Goodrich told Becker’s.
    • “This research builds from a 2024 study on how older adult-focused organizations can increase access to primary care, particularly among underserved populations.”
  • Per Modern Healthcare,
    • “UnitedHealth Group has named Sandeep Dadlani CEO of its Optum Insight technology arm, Dadlani announced in a social media post Thursday. 
    • “Dadlani previously served as UnitedHealth’s executive vice president and chief digital and technology officer. He succeeds Dhivya Suryadevara, who had served in that role and CEO of the Optum Financial healthcare banking division since May.
    • “In a LinkedIn post, Dadlani wrote that it was his first week as CEO of Optum Insight, which includes the Change Healthcare claims processing division.” 
  • and
    • “VillageMD is selling 32 Texas clinics to Harbor Health, an Austin-based primary and specialty clinic group that also offers health plans.
    • “The deal includes 10 clinics in Austin, 10 in San Antonio, six in El Paso and six in Dallas. More than 80 clinicians will join Harbor as part of the transaction, according to a Thursday news release. 
    • “Financial details were not disclosed.”
  • Beckers Payers Issues looks into why Blue Cross of Massachusetts consistently achieves a very high NCQA scorecard.

Midweek update

David Ermer–CDC, COVID-19 vaccine, FDA, HSA, Medical / Rx research, NCQA, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Roll Call lets us know,
    • “House Republican leaders overcame a key procedural hurdle Wednesday evening, paving the way for floor consideration of the short-term stopgap funding measure they will need to pass with GOP votes later this week due to near-uniform Democratic objections.
    • “The chamber adopted the rule for floor debate on the bill on a 216-210 party-line vote.” * * *
    • “If the GOP bill can get out of the House, [Senate Minority Leader Chuck] Schumer [(D NY)] did offer an exit strategy of sorts on Wednesday night, offering a chance to look at a future commitment to deal with the expiring exchange subsidies once the CR passes rather than insist on changes to the bill now before the Sept. 30 deadline.
    • “Well look, we have two weeks [until October 1, the beginning of the new federal fiscal year]. They should sit down and talk to us, and we maybe can get a good proposal,” Schumer said. “We’ll sit down and negotiate if they will sit down and negotiate. We don’t have a red line, but we know we have to help the American people.”
    • “Republican leaders argue the current income thresholds to qualify for the tax credits are too high, and GOP senators are discussing lowering those in any extension.”
  • The Wall Street Journal reports,
    • “The former director of the Centers for Disease Control and Prevention [Susan Monarez] said she was fired after refusing to compromise her scientific integrity, testifying that Robert F. Kennedy Jr. asked her to preapprove vaccine recommendations and remove career scientists.” * * *
    • “Republican senators largely defended Kennedy and sought to cast Monarez as either untrustworthy or disloyal. Some questioned her hiring of lawyers who have represented Hunter Biden and other officials targeted by Trump.” 
  • Here is a link to the Senate Health, Education, Labor and Pension Committee’s website on this hearing.
  • Roll Call tells us, “Senate Republicans took a final procedural step Wednesday to speed up consideration of President Donald Trump’s lower-level nominees, setting up the confirmation of dozens of appointees as early as this week.”
  • Modern Healthcare points out,
    • “The House passed the Lower Costs More Transparency Act of 2023 with a PBM provision in the last Congress. The Senate, however, only advanced PBM bills as far as committee consideration. At the end of 2024, a version of all those measures was added to a popular bipartisan package of healthcare legislation, in part because of the work of Rep. Buddy Carter (R-Ga.), a pharmacist who pushed the PBM provisions with House leaders. 
    • “The bill was on the verge of passing as part of the annual government funding bill when leaders pulled it from consideration because then-presidential adviser Elon Musk and President Donald Trump raised objections. PBM industry groups argued the provisions aimed at them were giveaways to drug companies, which they say are ultimately responsible for drug prices.
    • “In an interview [with Modern Healthcare], Carter said he expects PBM legislation to pass this year. 
  • The Plan Sponsor Council of America notes,
    • “The PSCA’s 2025 HSA Survey shows employees are increasing contributions to their health savings accounts, and more are investing those assets when given the opportunity, leading to an increase in average account balances for the third consecutive year.
    • “PSCA’s seventh annual HSA survey, sponsored by HSA Bank, was conducted in the summer of 2025 and reflects responses from nearly 600 employers with an HSA program. The survey tracks employee and employer HSA trends from 2024.
    • “The survey shows that 20 percent of participants now invest their HSA savings, up from 18 percent the prior year. Also, two-thirds of employers now offer investments, a 12 percent increase over a two-year period.”
  • Per MedTech Dive,
    • “The Food and Drug Administration posted two notices on Tuesday warning about unauthorized blood pressure and infant monitoring devices sold over the counter.
    • “Many devices for measuring blood pressure and monitoring infant vital signs are currently sold over the counter without FDA marketing authorization, the agency said. The FDA recommended looking for an authorized device.
    • “The regulator has sent warning letters in the past to companies for selling monitoring devices without authorization.” 
  • From Justice Department news releases,
    • “Today, the Antitrust Division of the Department of Justice announces its collaboration with the Federal Trade Commission (FTC) to identify over 125 anticompetitive regulations in response to the President’s Executive Order on Reducing Anti-Competitive Regulatory Barriers. Under the leadership of President Trump, the Antitrust Division, in close coordination with the FTC and federal agencies, conducted a comprehensive, government-wide effort to identify and reform anticompetitive regulations that distort markets and stifle competition.
    • “In America we believe in free markets, not central planning by government regulators or powerful monopolists,” said Assistant Attorney General Abigail Slater of the Justice Department’s Antitrust Division. “Lowering barriers to entry by removing anticompetitive regulations will free America’s innovators and entrepreneurs to do what they do best: drive America’s future success.”
  • and
    • “An indictment was unsealed Friday charging two Florida men for their roles in a scheme to submit approximately $34.8 million in false and fraudulent claims to Medicare for medically unnecessary products. As part of the scheme, the defendants and their co-conspirators targeted thousands of Medicare beneficiaries and, through deceptive telemarketing, persuaded them to accept medical equipment that they did not need, such as orthotic braces and continuous glucose monitors.” * * *
    • “According to court documents, Kenneth Charles Kessler III, 42, of Miami-Dade County, Florida, and Michael Andrew Gomez, 42, of Broward County, Florida, are charged in connection with their ownership and operation of seven durable medical equipment (DME) supply companies based in Florida. Kessler and Gomez are accused of paying illegal kickbacks and bribes to purported marketing companies that targeted thousands of Medicare beneficiaries with deceptive and aggressive telemarketing campaigns. The indictment alleges that these marketing companies obtained the beneficiaries’ personally identifiable information and arranged for purported telemedicine companies to generate doctors’ orders for unnecessary medical equipment. Kessler and Gomez allegedly used these doctors’ orders to submit false and fraudulent claims to Medicare through their network of DME companies.
    • “Kessler and Gomez are both charged with conspiracy to commit health care and wire fraud, two counts of health care fraud, conspiracy to defraud the United States and to offer and pay health care kickbacks, and two counts of offering and paying kickbacks in connection with a federal health care program. If convicted, Kessler and Gomez each face up to 65 years in prison. A federal judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.”

From the Covid vaccine front,

  • STAT News informs us,
    • “Amid growing concern about Americans’ access to vaccines, the country’s biggest health insurance association said its member plans will continue to cover all shots recommended by a federal advisory committee prior to any changes by its new slate of appointees.
    • “America’s Health Insurance Plans’ announcement comes just ahead of the first meeting of the Advisory Committee on Immunization Practices’ 12 members handpicked by Health and Human Services Secretary Robert F. Kennedy Jr. The selection of the five newest members was announced Monday, and their meeting is Thursday and Friday. Experts have speculated that, among other steps, the panel will drop the existing recommendation that newborns receive the hepatitis B vaccine, a move that could lead to a resurgence of the virus and, as a result, liver disease and cancer.” * * *
    • “AHIP said its plans will cover all vaccines recommended by ACIP as of Sept. 1, 2025, and that there would be no cost sharing for patients through the end of 2026. That includes updated Covid-19 and influenza vaccines. Health insurers are required to make vaccines free if they are recommended by ACIP and adopted by the Centers for Disease Control and Prevention, but AHIP’s pledge ensures coverage will continue even if the new members change the panel’s recommendations.” 
  • The Washington Post warns that ACIP could increase the age at which senior citizens can receive the Covid vaccine without cost sharing from 65 to 75.
    • “The people familiar with the deliberations cautioned that the situation is fluid and rapidly changing. The recommendations would also need to be approved by the acting director of the Centers for Disease Control and Prevention before taking effect, and it’s unclear how quickly that would happen.
    • “If a senior is concerned about losing access to a coronavirus vaccine, “they should absolutely try to get vaccinated as soon as possible,” said Caitlin Donovan, senior director at Patient Advocate Foundation. But even if more restrictive guidelines take effect, she noted most seniors have an underlying condition such as diabetes, heart issues or a history with smoking. * * *
    • “If you can’t find an appointment quickly, contact your primary care physician and discuss your options,” Donovan said. “They should be willing to write you a prescription after considering your risk levels.”
  • The New York Times adds,
    • “Four Democratic-controlled Western states on Wednesday issued their own recommendations on who should get three common seasonal vaccines, a sharp rejection of efforts by Health Secretary Robert F. Kennedy Jr. to upend vaccine policy at the federal level.
    • The so-called West Coast Health Alliance — which includes health officials in California, Oregon, Washington and Hawaii — recommended that every resident 6 months and older receive the flu vaccine this fall. They also recommended that broad swaths of the population receive a Covid-19 shot, including pregnant women and all children from 6 months to 2 years old, and that R.S.V. vaccines be given to infants under 8 months and adults over 75, as well as to others with certain risk factors.
    • “The detailed guidance generally mirrors clinical recommendations that have been made by the federal government and by national medical organizations such as the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.”

From the public health and medical/Rx research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Today in its weekly update, the Centers for Disease Control and Prevention (CDC) said there are 1,491 confirmed measles cases in the United States this year in 42 jurisdictions, an increase of 37 cases in the past week. 
    • “Eighty-six percent of cases have been linked to one of 38 reported outbreaks, and roughly 12% of all case-patients have required hospitalization. 
    • “Last year the country recorded only 285 measles cases, and 2025 has been the worst year for measles activity in the United States since the virus was officially declared to be eliminated in 2000.”
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) has launched an effort to advance research on whole-person health and create an integrated knowledge network of healthy physiological function. Whole person health involves looking at the whole person—not just separate organs or body systems—and considering multiple factors that promote health. For example, a multicomponent lifestyle intervention including healthy diet, physical activity and stress management may improve multiple and interconnected aspects of health including cardiovascular (e.g. blood pressure), metabolic (e.g. glucose metabolism) and musculoskeletal function (e.g. muscle strength).
    • “Biomedical research is largely organized around the study of specific organs and diseases. In contrast, we do much less research on health itself, which is an integrated process involving the whole person,” said Helene M. Langevin, M.D., director of NIH’s National Center for Complementary and Integrative Health, which leads the NIH-wide program.
    • “The five-year research initiative will proceed in several stages, drawing from existing scientific knowledge to develop a complete, working model of healthy human physiology. It will build on the NIH Human Reference Atlas and the Human BioMolecular Atlas Program (HuBMAP) to connect the complex anatomy and function of the body’s different organs and systems into a single “map.”
    • “Future stages of the project will link common clinical measures, such as blood pressure, blood glucose and cholesterol, to major physiological functions. This initiative will also populate the framework with existing human data and ultimately build and test an interactive model of whole-person health.
    • “By organizing healthy physiological function into a whole-body knowledge network, researchers will be able to explore scientific questions about health in a new way,” said Dr. Langevin. “With our ability to acquire new scientific data at an increasingly dizzying speed, the importance of integrating and connecting new data to what we already know is greater than ever. The Whole Person Reference Physiome will lay a foundation for understanding the factors that drive declines in health and mechanistic pathways to health restoration.”
  • and
    • “Research supported by the National Institutes of Health (NIH) shows that repeated head impacts from contact sports can cause early and lasting changes in the brains of young- to middle-aged athletes. The findings show that these changes may occur years before chronic traumatic encephalopathy (CTE) develops its hallmark disease features, which can now only be detected by examining brain tissue after death.
    • “This study underscores that many changes in the brain can occur after repetitive head impacts,” said Walter Koroshetz, M.D., director of NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “These early brain changes might help diagnose and treat CTE earlier than is currently possible now.”
    • “Scientists at the Boston University CTE Center, the U.S. Department of Veterans Affairs Boston Healthcare System and collaborating institutions analyzed postmortem brain tissue from athletes under age 51. Most of them had played American football. The team examined brain tissue from these athletes, using cutting-edge tools that track gene activity and images in individual cells. Many of these tools were pioneered by the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. The researchers identified many additional changes in brains beyond the usual molecular signature known to scientists: buildup of a protein called tau in nerve cells next to small blood vessels deep in the brain’s folds.
    • “For example, the researchers found a striking 56% loss of a specific type of neurons in that particular brain area, which takes hard hits during impacts and also where the tau protein accumulates. This loss was evident even in athletes who had no tau buildup. It also tracked with the number of years of exposure to repetitive head impacts. The findings thus suggest that neuronal damage can occur much earlier than is visible by the currently known CTE disease marker tau. The team also observed that the brain’s immune cells, called microglia, became increasingly activated in proportion to the number of years the athletes had played contact sports.”
  • The American Journal of Managed Care informs us,
    • “Early-onset T2D is rising in the US, especially among underserved populations, with a worse cardiometabolic profile than later-onset cases.
    • “Financial hardships are more significant for younger adults, women, and minority groups with T2D, necessitating policies addressing medical and financial well-being.
    • NHANES data from 1999 to 2020 shows increased prevalence of early-onset T2D, highlighting the need for improved screening and diagnosis in younger adults.
    • ‘Study limitations include cross-sectional data, potential recall bias, and exclusion of institutionalized populations, affecting generalizability and causal inferences.’
  • Per Healio,
    • “Walking quickly for 15 minutes per day was associated with a significant reduction in all-cause mortality and CVD mortality, according to a cohort study published in American Journal of Preventive Medicine.
    • “Many studies have explored the health benefits provided by regular walking, including recent findings on the ideal step count and how walking can improve life expectancy for middle-aged adults.”
  • The Wall Street Journal reports,
    • “Eli Lilly’s diabetes pill, orforglipron, showed better blood sugar control than Novo Nordisk’s oral semaglutide in a Phase 3 trial.
    • “Orforglipron met primary and secondary goals across doses, with some participants reaching near-normal blood sugar levels.
    • “Lilly said the results, combined with the pill’s scalability, show its potential as a key Type 2 diabetes treatment.”
  • Per BioPharma Dive,
    • “Roivant and subsidiary company Priovant said Wednesday their inflammatory disease pill succeeded in a Phase 3 trial in the rare condition dermatomyositis, significantly reducing signs and symptoms of the disorder by more than placebo when used for one year.”
    • “Company executives said they plan to ask the Food and Drug Administration to approve the pill, called brepocitinib, in early 2026, based on trial results they called “the first ever positive registrational trial for a targeted therapy” in dermatomyositis.
    • “Brepocitinib is being developed by Priovant Therapeutics, which is part owned by Pfizer. The big drugmaker licensed the pill to Roivant in 2022 as part of a pipeline cull.”
  • and
    • AstraZeneca reported divergent outcomes from two late-stage studies on Wednesday. In one Phase 3 trial, a subcutaneous form of its marketed medicine Sophnelo helped lower signs of disease activity in people with the most common form of lupus. In the other, its drug Fasenra, used to treat asthma and a few other conditions, failed meaningfully lower the rate of moderate or severe chronic obstructive pulmonary disease attacks. The under-the-skin injection of Sophnelo is being reviewed by regulators. AstraZeneca will analyze the Fasenra data to “further understand the results,” the company said.
  • Per Fierce Pharma,
    • “SK Biopharmaceutical’s Xcopri (cenobamate) met the bar in a phase 3 trial that could support the company’s ambitions of building a blockbuster with an expansion into another seizures subtype.
    • “The South Korean pharma won FDA approval for Xcopri in 2019 as a treatment for partial-onset seizures, also known as focal seizures, in adults. Since then, with rapid global growth, SK has outlined blockbuster ambitions for the drug by 2029. 
    • “Now, with a positive phase 3 trial, another indication for primary generalized tonic-clonic (PGTC) seizures could be on the table.”
  • Beckers Hospital Review identifies “four new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports
    • “Baltimore-based Johns Hopkins Medicine has ended contract negotiations with UnitedHealthcare without a new deal, The Baltimore Banner reported Sept. 15. 
    • “Johns Hopkins went out of network with UnitedHealthcare on Aug. 25 after eight months of negotiations and several extensions of their existing agreement. 
    • “Health system leaders did not rule out an agreement in the future, but a spokesperson told The Banner they decided to make patients “aware of this stalemate now, to provide our patients and their employers the time they need to explore alternative insurance options during the upcoming open enrollment season.” 
    • “Both parties have said the impasse was not about money but other provisions in the contract, according to the report. Johns Hopkins said UnitedHealthcare was demanding overly burdensome prior authorization requirements. The payer said the system wanted to be able to exclude certain employer-sponsored plans.
    • “UnitedHealthcare Mid-Atlantic CEO Joseph Ochipinti told the news outlet the payer remains at the negotiation table. He said they expect “network providers to honor their commitment to care for the individuals and families who rely on them as in-network providers.”
  • and
    • lists the top NCQA rated commercial health plans in each state.
  • Per a Healthcare Cost Institute news release,
    • “Primary care offers patients a critical connection point to the health care system. With contact, continuity, comprehensiveness, and coordination as its base1, primary care has been shown to improve health outcomes and population health, reduce health disparities, and save health care dollars. Despite the virtues and benefits of primary care, it seems to be getting harder to access. In 2025, there were 7,901 primary care health professional shortage areas. A recent report found that primary care physicians per capita declined between 2012 and 2021, and fewer trainees chose to pursue primary care than specialty care over the same period.
    • “In response, a number of states are innovating to increase investment in primary care. By one estimate, nearly 20 states have taken action to improve primary care with initiatives ranging from defining and measuring primary care to setting specific primary care spending targets.
    • “This analysis assesses what portion of total health care spending is dedicated to primary care, in alignment with many of the primary care spending targets that are expressed as a percentage of total health care spending. We defined the percentage of primary care as the portion of ambulatory spending rendered by primary care providers (PCPs) relative to total medical and prescription spending among people with Employer-Sponsored Insurance (ESI) and Medicare Fee-for-Service (FFS) between 2018 and 2022. 
    • “The results presented below are based on a narrow definition of primary care provider based on provider specialty. We conducted the same analysis using an expanded list of specialties, (e.g., obstetrics and registered nurses and other allied practitioners). As expected, the share of primary care spending was higher using the broader definition. Otherwise, the patterns observed with the narrow definition also applied to the broader definition. The results of the analysis using both definitions are available in the downloadable data.
    • “Approximately 4% of spending went to primary care in 2022.”
  • Beckers Health IT lets us know,
    • “Epic’s revenue rose to $5.7 billion in 2024, a company spokesperson told Becker’s, as the EHR vendor continues to add health system customers.
    • “That number is up from $4.9 billion in 2023 and $1.2 billion in 2012. Epic has continued to consolidate its U.S. market share lead over the past few years, from 31% of acute care hospitals in 2021 to 42.3% in 2024, per KLAS Research. Its nearest competitor, Oracle Health, clocked in at 22.9%. Epic is the market share leader for all U.S. acute care hospital types except standalone facilities with 200 beds or fewer.”

Thursday report

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

From Washington, DC,

  • Per a Congressional news release,
    • “[Yesterday,] the House Appropriations Committee met to consider the Fiscal Year 2026 Financial Services and General Government Appropriations Act. The measure was approved by the Committee with a vote of 35 to 28.”
    •  Among other provisions, the bill “prohibits the Federal Employees Health Benefit Program from covering puberty blockers, hormone therapy, or surgical procedures for gender affirming care.”
  • Healthcare Dive notes,
    • “At a House subcommittee hearing on Wednesday, lawmakers expressed concerns about whether artificial intelligence is being appropriately used in healthcare and called for stronger guardrails to supervise the quickly evolving technology.
    • “With all these innovative advancements being leveraged across the American healthcare ecosystem, it is paramount that we ensure proper oversight is being applied, because the application of AI and machine learning will only increase,” said Energy and Commerce subcommittee Chair, Rep. Morgan Griffith, R-Va.”
  • The Wall Street Journal reports,
    • “Health Secretary Kennedy faced bipartisan Senate [Finance Committee] questioning regarding CDC turmoil and changes to U.S. vaccine policy.
    • “Kennedy defended his actions as necessary to restore the CDC, while critics raised concerns about vaccine access and his appointees.
    • “The CDC is facing internal strife after the ouster of its director and calls for Kennedy’s resignation from employees.”
  • MedPage Today adds,
    • “HHS Secretary Robert F. Kennedy Jr. has chosen seven new members for the CDC’s Advisory Committee on Immunization Practices (ACIP), according to information obtained by MedPage Today‘s editor-in-chief Jeremy Faust, MD.
    • ACIP’s next meeting is set to take place Sept. 18-19, and the posted agenda states that “recommendation votes may be scheduled” for immunizations against hepatitis B, COVID, and respiratory syncytial virus, as well as the measles, mumps, rubella, and varicella shot.
  • STAT News tells us,
    • “After months of uncertainty, the Trump administration confirmed that it will work with Gilead Sciences and The Global Fund to Fight AIDS, Tuberculosis and Malaria to provide a groundbreaking HIV prevention drug to up to 2 million people in low- and middle-income countries.
    • “The ambitious effort was first announced late last year but doubts quickly emerged after the Trump administration began to drastically cut foreign aid. The move appeared to jeopardize the future of the President’s Emergency Plan for AIDS Relief, or PEPFAR, which has long been the world’s leading provider of HIV prevention drugs. Only about half of its $6 billion budget has reportedly been appropriated.
    • “Nonetheless, The Global Fund, which pools money from public and private donors, maintained it would proceed with plans to purchase and distribute the Gilead medication, called lenacapavir. The antiviral offers virtually complete protection against contracting HIV with just a single administration every six months and has been hailed as a tool that could bring the 45-year-old pandemic to heel.” 
  • and
    • “A key government study about alcohol and its health harms will not be released publicly, despite several years of taxpayer-funded work and a growing body of evidence connecting drinking with disease. 
    • “A final version of the Alcohol Intake and Health Study led by the Substance Abuse and Mental Health Services Administration will not be published, “to the detriment of the people’s health,” scientific review panelist Priscilla Martinez told STAT in an email Thursday morning. Another panel member confirmed that they have not heard from the Trump administration since submitting their work months ago. News of the killed report was first reported by Vox.”
  • The American Hospital News informs us,
    • “The Department of Health and Human Services Sept. 4 announced new hardship exemption guidance that would allow consumers ineligible for premium tax credits or cost-sharing reductions to enroll in catastrophic health coverage. Consumer eligibility will be based on projected annual household income. The Centers for Medicare & Medicaid Services made this change in light of the significant anticipated rise in individual market premiums and the expiration of the enhanced premium tax credits at the end of the year.”
  • Modern Healthcare relates,
    • “The Federal Trade Commission asked the public to weigh in on noncompete contract provisions, even though district courts have blocked the commission’s nationwide ban on most of those agreements. 
    • “The agency issued a request for information Thursday, seeking detail about employers who unfairly restrict employees from working for a rival organization through noncompetes. These agreements can stunt wage growth, limit competition, reduce innovation and inflate prices, the FTC said.
    • The commission said the consequences are magnified in healthcare where noncompete agreements can restrict patient access, particularly in rural areas. The comment period will close Nov. 3. 
  • Axios interviews OPM Director Scott Kupor.
    • Q “You’re nominated in December but not confirmed until July. In the meantime, Elon Musk and DOGE make lots of major personnel decisions via OPM. Were you just sitting on your hands?
    • A “The short answer is yes. That’s the rules. I wasn’t even allowed to go into the building, so I was just trying to interpret what was happening. The only time I got more insight was when I started prepping for the Senate confirmation hearing, because I got briefed so I wouldn’t look like a complete idiot.” * * *
    • Q You’ve also talked about establishing more of a merit-based system for federal workers. But DOGE often fired probationary workers, not because of merit but because of where they were on the totem poll.
    • A “It was only around 5,800 probationary employees out of 2.4 million across the entire government. Yes, I’m sure many of those were under 30, and the government has a real problem getting younger workers — only 7% under 30 compared to 24% in the normal workforce — but you still need to view it in context.”
    • Q Of that 2.4 million, how many do you want still working for the government at year-end?
    • A “Around 2.1 million, which is where we were when the first Trump administration took office … That doesn’t include the military, which OPM isn’t responsible for.”
  • FedSmith points out,
    • “The percentage of federal employees working on site has more than tripled from its low point of the last three years according to new data released by Gallup.
    • “The new Gallup poll data show that as of the second quarter of 2025, 46% of federal employees in Washington, DC now work fully on site. This is more than double the national average of 21% and more than triple the low point of 14% back in Q1 2022.
    • “Also, the percentage of federal employees working in a hybrid model (employees who work both on-site and remotely) dropped sharply since President Trump took office, going from 61% at the end of 2024 to 28% in Q2 2025.”
  • At long last, the Spring 2025 semi-annual regulatory and deregulatory agenda has appeared on reginfo.gov.
    • OPM agenda has one FEHB entry reading
      • “The Office of Personnel Management (OPM) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that would have amended the Federal Employees Health Benefits (FEHB) regulations at 5 CFR part 890 that would have allowed FEHB coverage to take effect at the beginning of the pay period that an employee in pay status has an initial opportunity to enroll. OPM is withdrawing the proposed rule as additional research determined that the potential costs to agencies for making updates to business systems and processes for an additional two weeks of FEHB coverage is not an effective use of resources.” 

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “Kardium has received premarket approval for its Globe pulsed field ablation system, as well as 510(k) clearances for both the Globe Introducer sheath and mapping software, the company said Wednesday. 
    • “The Food and Drug Administration authorization positions Kardium, which raised $250 million to fund commercialization in July, to launch the system as a treatment for atrial fibrillation.
    • “Kardium is entering a fast-growing market served by Boston Scientific, Johnson & Johnson and Medtronic. The company cited Boston Scientific and Medtronic devices as 510(k) predicates.”

From the public health and medical/Rx research front,

  • The New York Times fills us in about flu shots this fall.
  • Health Day reports,
    • “A single dose of RSV vaccine might protect seniors for two cold and flu seasons in a row, a new study says.
    • “Vaccination reduced seniors’ risk of hospitalization by 58% during two RSV seasons, researchers reported Aug. 30 in the Journal of the American Medical Association.
    • “These results clearly demonstrate that the RSV vaccines prevent hospitalizations and critical illness due to RSV infection among older Americans,” said principal investigator Dr. Wesley Self, senior vice president for clinical research at Vanderbilt University Medical Center in Nashville, Tennessee. “It is exciting to see the public health benefits of this new vaccination program.”
    • “However, the vaccine’s effectiveness waned between the first and second years, raising questions regarding how often seniors should get the jab.” * * *
    • “Redosing the vaccine at some interval after the initial dose could be a strategy to maintain protection over longer periods of time,” Self said. “It will be important to continue to closely monitor vaccine effectiveness over time to understand how long the benefit lasts after a single dose and if repeat dosing should be considered.”
  • Per Tech Target,
    • “One in six women have missed a routine cancer screening in the past year, underscoring deep care gaps imperiling health outcomes, according to new data obtained via email.
    • “The data, gleaned from the full dataset from the Prevent Cancer Foundation’s annual Early Detection Survey, showed that women tend to stay up to date on other ordinary tasks — like getting a haircut, renewing their driver’s license or donating their old clothes — more than their preventive cancer screenings.
    • “Instead, women mostly only schedule a preventive screening when they are experiencing the signs or symptoms of disease, with 33% of respondents saying as much.
    • “Early detection equals better outcomes, so we can’t wait until our bodies are screaming at us to check our health. Women need to prioritize their own health by going to the doctor even when everything feels fine,” Jody Hoyos, CEO of the Prevent Cancer Foundation, said in an emailed statement. “Routine checks and screenings provide an opportunity to stay ahead of cancer, so if there is an issue, you can deal with it before it becomes a bigger problem down the road.”
  • Per STAT News,
    • “One of the worst places for cancer can spread is the leptomeninges, the inner membranes encasing the brain and spine. Patients with these metastases have limited treatment options and tend to succumb to the disease rapidly. But a new study suggests that using proton beam therapy might make it possible to more effectively treat these cancers with radiation and dramatically extend survival.
    • “There’s so little we have to offer patients with leptomeningeal metastasis that really, truly works,” said Lauren Boreta, a radiation oncologist at the University of California San Francisco, who did not work on the study. Treatments that increase survival, the way this study showed proton beam radiation did, is “unheard of for these patients,” she said. “It’s shocking. We haven’t had an advance in this space for maybe ever.” * * *
  • The Washington Post explains “the health risks from plastics almost nobody knows about Phthalates, chemicals found in plastics, are linked to an array of problems, especially in pregnancy.”
  • Per MedTech Dive,
    • “Cardiologists are welcoming the arrival of a new device-based hypertension treatment called renal denervation and asking Medicare to cover the procedure for a large patient population.
    • “Doctors, medical groups and others have endorsed national reimbursement for renal denervation in dozens of public comments submitted to the Centers for Medicare and Medicaid Services ahead of a final Medicare coverage decision expected by early October. Many cite concern about the high numbers of patients whose blood pressure remains poorly controlled despite the availability of multiple drug treatments.” 
  • Genetic Engineering and Biotechnology News reports.
    • “A key to understanding the brain lies in unpacking how hundreds of interconnected brain areas process information that leads to various outputs. In order to try to understand this, researchers investigate both single neurons and groups of neurons together. Now, a major advance in this area of neuroscience study has been published: the first complete activity map of the brain has been unveiled by a large international collaboration of neuroscientists.
    • “Two papers published in Nature reveal insights into how decision-making unfolds across the entire brain in mice at the resolution of single cells. This brain-wide activity map shows that decision-making is distributed across many regions in a highly coordinated way.”
    • “This is the first time anyone has produced a full, brain-wide map of the activity of single neurons during decision-making,” explained Professor Alexandre Pouget, PhD, co-founder of the International Brain Laboratory (IBL) and group leader at the University of Geneva. “The scale is unprecedented as we recorded from over half a million neurons across mice in 12 labs, covering 279 brain areas, which together represent 95% of the mouse brain volume. The decision-making activity, and particularly reward, lit up the brain like a Christmas tree.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Employees of large and small companies are likely to face higher health care costs, with increases in premiums, bigger deductibles or co-pays, and will possibly lose some benefits next year, according to a large survey of companies nationwide that was released on Thursday.
    • “The survey of 1,700 companies, conducted by Mercer, a benefits consultant, indicated that employers are anticipating the sharpest increases in medical costs in about 15 years. Higher drug costs, rising hospital prices and greater demand for care are all contributing factors, experts said.
    • “With the projected increases, this is the fourth consecutive year in which employers — and their workers — have faced significantly higher costs for health insurance, with next year representing the biggest jump since 2010.” * * *
    • “Without making any changes to benefits — which would involve moves like shifting more costs to workers or reducing benefits — employers said they expected next year’s increases in health costs to reach nearly 9 percent on average. By altering plans, they projected increases overall of 6.5 percent on average in health costs next year.
    • “A quarter of those surveyed projected double-digit increases for 2026 even after changes to plans.”
  • Modern Healthcare relates,
    • “Elevance Health will cut some Medicare Advantage plans and fully exit the Medicare Part D standalone prescription drug market next year. 
    • “The for-profit Blue Cross and Blue Shield licensee will eliminate unprofitable Medicare Advantage plans covering approximately 150,000 individual and group members in total, Chief Financial Officer Mark Kaye said Thursday during the 2025 Wells Fargo Healthcare Conference. The company has prioritized HMO and Dual Special Needs Plan coverage for 2026, he said.
    • “Elevance Health is the fourth-largest Medicare Advantage carrier, with 2.3 million enrollees. It counts 400,000 standalone Part D members, making it the sixth-largest carrier, according to a July report by KFF, a healthcare research firm. It is one of seven companies that sell standalone Part D plans, KFF said. Fee-for-service Medicare beneficiaries purchase the coverage to help offset their prescription drug costs.” 
  • Beckers Payer Issues adds,
    • “UCare has asked CMS to mutually terminate its Medicare Advantage plans for 2026, citing rising medical costs and challenges within the broader market.
    • “This decision was not made lightly,” President and CEO Hilary Marden-Resnik said Sept. 4 “UCare remains deeply committed to the health of Minnesotans and to supporting members through upcoming transitions.”
    • “UCare has more than 600,000 members in Minnesota and parts of western Wisconsin, including 158,000 MA members. It is the second largest MA carrier in the market, with 26% percent market share. The company will continue to offer Medicaid, special needs plans, Medicare supplement and ACA coverage.”

Midweek Update

David Ermer–CDC, CMS, COVID-19 vaccine, Generative AI, Government Contracting, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Meritalk reports,
    • “With the Office of Personnel Management (OPM) on track to lose one-third of its workforce by the end of the year, OPM Director Scott Kupor said on Tuesday that he’s looking to technology to help steady the agency during its ongoing restructuring.
    • “Kupor, who the Senate confirmed as OPM director last month, said that his team is currently conducting a “reprioritization” effort to determine the top critical areas for the agency to focus on – and whether or not they need more headcount to get the job done.
    • “There may be cases where maybe we actually are short people,” Kupor said during an Aug. 26 event hosted by Federal News Network.
    • “We’re not perfect, and I fully acknowledge that there just may be areas where we need to revisit. So, there will be, I’m sure, some places where we have cut deeper than was appropriate, and we’ll have to make some changes,” he said.
    • “Some of those hiring efforts could target fresh talent, but Kupor said the agency may also look to rehire some employees who chose to participate in the deferred resignation program.”
  • The Wall Street Journal reports at 8:35 pm ET Wednesday,
    • “Susan Monarez, the director of the Centers for Disease Control and Prevention, has been pushed out of the job, a senior Trump administration official said Wednesday.
    • “Monarez, who led the agency for less than a month, clashed with Health and Human Services Secretary Robert F. Kennedy Jr. and members of his staff, the official said. President Trump had nominated her to lead the CDC in March after dropping his first pick. Previously the agency’s acting director, Monarez was the first CDC head without a medical degree in more than 70 years.
    • “Lawyers for Monarez said in a statement that she has neither resigned nor received notification from the White House that she has been fired. They also said she will not resign. “When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda,” they said. “For that, she has been targeted.”
    • “Three senior CDC leaders, including Dr. Debra Houry, the agency’s chief medical officer, submitted their resignations Wednesday, according to emails viewed by The Wall Street Journal.”
  • Healthcare Dive tells us,
    • “The process set up by the No Surprises Act to settle disputes between providers and insurers about out-of-network claims is generating billions of dollars in extra costs for the healthcare system — costs that could trickle down in the form of higher consumer premiums, according to a new analysis.
    • “Independent dispute resolution, or IDR, has created an estimated $5 billion in total costs between its inception in 2022 and the end of last year, according to the report published in Health Affairs on Monday. The high amount of claims, significant provider participation and lofty offer amounts are driving the spending, researchers found.
    • “The analysis raises questions for policymakers concerned about curbing healthcare costs. In particular, Washington should consider tackling the high volume of ineligible disputes clogging up the process — and scrutinize the role of private equity, given providers backed by the firms are responsible for an outsized portion of disputes, researchers said.”
  • FEHBlog note — The No Surprises Act arbitration which is supposed to resemble baseball arbitration fails to include the safeguards found in actual baseball arbitration like a hearing at which the parties have access to both offers and can debate them before the decisionmakers.
  • Fierce Healthcare informs us,
    • “The National Committee on Quality Assurance (NCQA) has launched an artificial intelligence working group to determine how to best measure performance of high-risk AI once it has been deployed by health plans and providers. 
    • “The 35-year-old organization runs a spate of quality measurement and reporting programs, like health plan accreditation and the Healthcare Effectiveness Data and Information Set (HEDIS) measures used by 90% of health plans, according to the Office of the Assistant Secretary for Planning and Evaluation. 
    • “The NCQA has convened more than 30 organizations to share their experiences using AI and help create standards for the technology. Some members of its AI working group are the American Academy of Family Physicians, America’s Health Insurance Plans, Blue Cross Blue Shield of Tennessee, the Community Care Plan, Covered California, the Kaiser Foundation Health Plan and United HealthCare.
    • “As the modality of care, as the channels of healthcare delivery continue to evolve, and as we continue to see a very evolving healthcare delivery landscape, we do want to take a very hard look at what additional things we can do to continue putting that lens on quality and putting quality front and center,” Vik Wadhwani, chief transformation officer at NCQA, said in an interview.”
  • Kushner & Co. reminds us that the time for circulating Medicare prescription drug creditable coverage notices is approaching. The deadline is October 15, 2025.
    • For 2025, with the Inflation Reduction Act lowering the out-of-pocket maximum to $2,000 (from $8,000 in 2024), many employer prescription drug plans—and especially those with High-Deductible Health Plans—may find that their plans are no longer creditable. Further, new changes for 2026 may also impact these notices. Be sure to check with your group medical plan insurance carrier or TPA [or PBM] to ensure you’re in compliance in determining whether your prescription drug plan is creditable or noncreditable.
  • The FAR Council today finalized the inflation adjustments to FAR thresholds which take effect on October 1, 2025. The key change for FEHB carriers is the following:
    • “The cost or pricing data threshold at FAR 15.403–4, for contracts awarded before July 1, 2018, increases from $750,000 to $950,000. For contracts issued on or after July 1, 2018, the threshold increases from $2 million to $2.5 million.”
    • 90 Fed. Reg. 41873 (August 27, 2025)
    • OPM’s FEHBAR treats this threshold as the subcontract preapproval threshold for experience rated carriers and the flow down trigger for the significant events clause. 48 C.F.R. Secs. 1652.222-70, 1652.244-70.

From the Food and Drug Administration (FDA) front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration authorized three new Covid-19 vaccines—from Pfizer and its partner BioNTech, and Moderna and Novavax—that target a variant of the coronavirus known as LP.8.1. This was the dominant circulating strain when FDA advisers picked a target in May. 
    • “The companies are expected to begin shipping doses to pharmacies and other vaccination sites within days. This is the fourth-year companies have updated Covid shots to target the primary variant that is circulating, in hopes the shots will better protect people from severe illness through the fall and winter months.
    • “In a change this year, the FDA cleared use of the updated vaccines in a smaller population. The three vaccines are cleared for everyone 65 and older, and for people in younger populations who have underlying conditions that put them at higher risk of severe Covid-19. 
    • “Pfizer’s vaccine was cleared for at-risk people ages 5 through 64, Moderna’s in at-risk people six months and older, and Novavax for at-risk people 12 and older.
    • “In previous years, U.S. health officials recommended the booster shots in most people six months and older, even if they didn’t have at-risk conditions.” * * *
    • “In deciding on vaccine coverage, health insurers typically follow recommendations by the Advisory Committee on Immunization Practices, or ACIP, which advises the CDC. They may also consider clinical recommendations from medical societies. 
    • “No meeting has been scheduled for ACIP to consider the new updated boosters. Kennedy fired all members of the ACIP in June and replaced them with people including some vaccine skeptics.
    • “A trade group for health-insurance companies, America’s Health Insurance Plans, said health plans will continue to follow requirements for ACIP-recommended vaccines.”
  • FEHBlog note — Indeed, the Affordable Care Act requires that health plans waive cost sharing for in-network administration of vaccines recommended by ACIP and confirmed by the CDC (or the HHS Secretary in the event of a vacancy in the CDC directorship.).
  • Cardiovascular Business adds,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about a new safety issue associated with Johnson & Johnson MedTech’s Automated Impella Controller (AIC). 
    • “This latest alert was put in place after Johnson & Johnson MedTech received reports that some of the Pump Driver Circuit Assemblies of its AICs contain 25V-rated tantalum capacitors instead of the expected 35V-related tantalum capacitors. This can cause the pump’s performance to suffer, and there a risk of the pump stopping altogether and triggering an “Impella Failure” or “Impella Stopped. Controller Failure” alarm. 
    • “One patient death has been linked to this issue. 
    • “This alert covers a total of 69 AICs. Full lists of the affected product codes and serial numbers are available as part of the FDA’s advisory. Anyone with one of the affected devices is urged not to use it any longer. Instead, the device should be quarantined until additional information is made available.
    • “The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” according to the advisory.”

From the judicial front,

  • Bloomberg Law reports,
    • “Cigna Health & Life Insurance Co. reached a class-wide settlement in a family’s lawsuit saying the insurer breached its fiduciary duties by failing to maintain an up-to-date list of in-network medical providers.
    • “The parties reached a preliminary agreement after a mediation session with a retired judge and plan to file details of the deal for court approval by Sept. 19, they said in a status report docketed Monday in the US District Court for the Northern District of Illinois. The filing didn’t include details about the terms of the settlement.” * * *
    • “Judge Manish S. Shah allowed portions of the case to advance in February, saying the family has a viable fiduciary breach claim based on Cigna’s failure to properly resolve the matter in a way that didn’t force them to foot the bill. But Shah dismissed the family’s claim for wrongfully denied benefits under the Employee Retirement Income Security Act because Cigna correctly paid their benefits according to the terms of their health plan.”

From the public health and medical research front,

  • Fierce Healthcare lets us know,
    • “Advancements in technology, testing and imaging have transformed cancer detection and risk assessment, enabling them to be faster and more precise.
    • “But providing patients with a cancer risk score or identifying those at high risk is only one step in cancer prevention. Getting patients to act on their cancer risk and get supplemental screening is the next big leap, and CancerIQ is focused on closing this gap.
    • “The company, which offers healthcare providers a cancer-focused precision health platform, developed new capabilities to provide patients at elevated risk for cancer with “hyper-personalized” patient education, engagement and navigation support. The new features were built on insights from thousands of high-risk patient journeys and backed by behavioral science with the aim to drive sustained follow-through on supplemental screenings that detect cancer earlier, according to executives.
    • “The first release focuses on screening breast MRI, with plans to support additional patient populations, including those eligible for low-dose lung CT.”
  • BioPharma Dive reports,
    • “People with early breast cancer who were treated in a late-stage study with Eli Lilly’s drug Verzenio and standard hormone therapy lived longer than those given hormone therapy alone, the company reported Wednesday.
    • “The summary results come from Lilly’s monarchE study, which began in 2017 and enrolled more than 5,600 adults with high-risk breast cancer that tested positive for hormone receptors but negative for a protein called HER2. Lilly said the improvement in survival was “statistically significant and clinically meaningful.”
    • “The study previously met its main goal, showing the addition of Verzenio improved invasive disease-free survival — data that supported a 2021 approval in this treatment setting. The overall survival findings, which were a secondary endpoint, will be presented at an upcoming medical meeting, Lilly said.”
  • STAT News relates,
    • “Akeso, a Chinese biotech with a drug positioned to rival Merck’s megablockbuster Keytruda, has reported for the first time that the therapy can improve patient survival.
    • “The therapy, ivonescimab, showed a statistically significant survival benefit as a second-line treatment when combined with chemotherapy to treat non-small cell lung cancers. The patients’ cancers had progressed after getting therapies targeting EGFR, a protein that can drive tumor growth. 
    • “The company described the results of the Chinese trial as clinically meaningful in a report for the first half of the year released on Tuesday. But it didn’t delve into details, which Akeso plans to share at an upcoming medical conference.”
  • Per Fierce BioTech,
    • “Amylyx’s withdrawn-from-market Relyvrio has failed to make an impact on primary or secondary endpoints in a rare neurodegenerative disease, prompting the company to discontinue the program.
    • “Oral therapy Relyvrio, which Amylyx is again referring to as AMX0035, was tested in progressive supranuclear palsy (PSP), a fatal and rapidly progressing condition that impacts mobility, eye movements, swallowing and speech. Currently, there aren’t any approved treatments for the disease.”
    • “Amylyx’s phase 2/3b study was measuring AMX0035’s impact on disease progression and severity using a 28-item, condition-specific scale. The phase 2 portion of the trial found no difference in patients receiving AMX0035 compared to placebo at 24 weeks, according to an Aug. 27 company release.
    • “Given the results, the company has discontinued the phase 2b trial, plus a related open-label extension study. Amylyx has also terminated plans for the phase 3 portion of the study.”
  • Per Health Day,
    • ‘Few teens with depression receive treatment, with disparities seen based on residence, gender, and race, according to a study published online Aug. 20 in PLOS Mental Health.
    • “Su Chen Tan, from the University of Tennessee in Knoxville, and colleagues used data from adolescents (aged 12 to 17 years) with major depressive episodes (MDE) participating in the 2022 U.S. National Survey on Drug Use and Health to assess mental health service utilization by rurality, race/ethnicity, gender, age, health insurance coverage, and poverty level.
    • “The researchers found that 19.2 percent of adolescents experienced MDE, but only 47.5 percent received treatment within the past year. There were significantly lower odds of receiving specialist treatment for adolescents in rural areas versus their urban counterparts (adjusted odds ratio [aOR], 0.64). Further, odds of receiving telehealth services were significantly lower for rural adolescents (aOR, 0.64) but were significantly higher for adolescents with insurance (public insurance: aOR, 2.99; private insurance: aOR, 3.82). Compared with younger adolescents, older adolescents had lower odds of utilizing school-based services (aOR, 0.52). Female adolescents had greater odds of utilizing any mental health treatment than male adolescents (aOR, 1.59), while Black adolescents had significantly lower odds of utilizing any mental health treatment versus non-Hispanic White adolescents (aOR, 0.36).”
  • and
    • “Two-thirds of women in their child-bearing years have an increased risk for birth defects due to a lifestyle factor they can change, a new study says.
    • “These risk factors — low levels of vitamin B9 (folate), unmanaged diabetes or exposure to tobacco smoke — increase the odds of a serious birth defect in any child they might have, researchers said.
    • “Heart defects, cleft palates and defects of the brain and spinal cord are among the problems that could be headed off if women took steps to improve their health prior to pregnancy, researchers reported today in the American Journal of Preventive Medicine.”

From the U.S. healthcare business front,

  • Healthcare Dive points out Blue Shield of California names interim CEO Mike Stuart to permanent chief executive.
  • Beckers Payer Issues notes,
    • “AM Best has downgraded its outlook for the health insurance sector from stable to negative, citing escalating medical costs and increased utilization across government, commercial and ACA plans.
    • “The credit rating agency noted higher utilization of specialty drugs, increased physician visits, more inpatient admissions and a surge in behavioral health claims. The coding intensity of medical services has also increased, according to an Aug. 25 news release.”
  • STAT News reports,
    • “Dressed in red and black jackets reminiscent of Star Trek uniforms, the heads of Epic’s data and AI divisions, Phil Lindemann and Seth Hain, described an aspirational vision for artificial intelligence at the end of last week’s Epic UGM keynote. Using the data stored in Cosmos — Epic’s de-identified patient record research database — the company trained an AI model that can generate many possible future timelines for a patient, then tell the doctor which outcomes are most likely, like what might happen during a hospital stay, or if the patient might end up in the emergency department in the next year. 
    • “Just as a large language model can be trained once and then used to generate different kinds of text, like an email or a poem, without being specifically trained on how to write either emails or poems, Epic’s “large medical model,” trained on all sorts of medical events and outcomes, could replace individual predictive medical algorithms. If the model, which Epic calls CoMET — the Cosmos Medical Event Transformer — can achieve performance similar to machine learning algorithms specifically trained to predict readmissions or asthma attacks, “that’s a breakthrough in how we can get risk prediction embedded into clinical care,” said Lindemann.
    • “This idea isn’t entirely new. Researchers like Arkadiusz Sitek at Massachusetts General Hospital have built models that predict future patient medical events before. But, Sitek told STAT, the scale of CoMET is impressive and suggests this approach will work in a large population. Epic trained and evaluated its model on 115 billion medical events from 118 million unique patient records collected from January 2012 to April 2025. The work was detailed in a preprint posted last week with Microsoft and Yale researchers.”
  • FIerce Healthcare informs us,
    • “Four hospitals are sending heart failure patients home with a virtual care support team under a newly unveiled collaboration between the American Heart Association (AHA) and remote chronic disease monitoring platform Cadence.
    • “The American Heart Association Connected Care pilot program aims to reduce 30-day readmissions by addressing “critical gaps in heart failure care” that occur after heart failure patients leave the hospital.
    • “It will see the participating hospitals integrate program referrals into their discharge workflows. Enrolled patients are given and taught to use connected vital sign monitors, which a Cadence virtual care team uses to provide ongoing clinical support, adjust treatments or direct the patient to an in-person provider if necessary.
    • “Almost one in four heart failure patients are readmitted to the hospital within 30 days of discharge, and fewer than a fifth receive post-discharge medical therapies in line with clinical guidelines, according to study data cited in the announcement.”
  • Beckers Hospital Review identifies “five new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.”